June 16, 2009

New scorecard released on med center conflicts of interest

The American Medical Student Association today released its 2009 scorecard on academic medical center conflict of interest issues.

The group gave A grades to:

Mount Sinai School of Medicine, New York, NY
University of California San Francisco School of Medicine
Mayo Medical School - College of Medicine
University of Pittsburgh Medical Center
University of California Davis School of Medicine
University of Texas Medical Branch at Galveston
University of Pennsylvania School of Medicine
Johns Hopkins School of Medicine
UCLA David Geffen School of Medicine

The group said this about my local school - the University of Minnesota Medical School:

This institution has informed us that they are revising or developing their policies. However they have provided material for review.

Most of the policies regulating conflict of interest at University of Minnesota Medical School demonstrate progress towards a model policy, but could be strengthened further. There are no policies regulating off-site educational events or pharmaceutical samples, and oversight and sanctions for noncompliance are not clearly established.

This institution made a new or revised policy submission to the AMSA PharmFree Scorecard in 2009. Their status is In Process. Their grade improves provisionally from a D to a C.

This institution has not consented to allow their policy to be publicly posted or quoted for illustrative purposes.

A provisional C. This comes after the school spent a year researching and writing new conflict of interest recommendations. Hmmmm.

AMSA reports that "Of 149 US medical schools, 9 receive As (6%), 36 Bs (24%), 18 Cs (12%), and 17 Ds (11%). 35 schools (23%) receive a grade of F."

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May 14, 2009

More vested interest vilification of virtual colonscopy decision

The Colon Cancer Alliance has distributed a statement of disappointment over Medicare’s decision not to pay for virtual colonoscopy.

Let's do a reality check on what they say in that statement.

"This decision now leaves millions of older Americans exposed to a higher risk of colon cancer.”

• Nope. Not one bit higher than it was the day before the decision was made. The risk is the same. Ridiculous fear-mongering rhetoric.

“It also exacerbates an unequal standard of care between Medicare beneficiaries, who do not have the choice to undergo a virtual colonoscopy, and those with private insurance who do.”

• Euphemism for rationing – battle cry of almost any anti-health care reform movement.

"By denying coverage for virtual colonoscopy, CMS is sending the signal that increased screening amongst the Medicare beneficiary population is unimportant.”
• Hmmm. I didn’t get that signal at all. I heard a signal of “show me the evidence in a Medicare population.” Period. There's no denial of payment for methods WITH solid evidence in a Medicare population.

By the way, the Colon Cancer Alliance is sponsored by a host of drug companies and by GE Healthcare, which makes and sells virtual colonoscopy machines.

Let's be clear: I don't have a dog in this hunt. I have nothing to gain or lose by Medicare's payment decisions - no more than any other taxpayer. But I can't stand the rhetoric. And I'm going to write about it whenever I have the chance.

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April 10, 2009

Big bucks on display at American College of Cardiology meeting

From the weekly newsletter of former US Senator David Durenberger (R-Minn.) at the National Institute for Health Policy at the University of St. Thomas:

At the recent meeting of the American College of Cardiology in Orlando, FL., 340 health companies paid $6 million for exhibit space. Of that, $3 million, plus another $1 million from medical drug/device industry went to the ACC to reduce the cost of attending the conference for cardiologists (who are among the highest income specialists in the country). The Pew Charitable Trusts have funded work by Columbia University physician David Rothman and others into the issue of appearance of conflict of interest at the intersection of medical education and medical decision-making. The resistance from doctors is enormous, because the financial rewards have always been very substantial.

That's the rationale behind every politician, every corporate CEO and every professional who claims "I can't be bought," while at the same time admitting they can't live without it.

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April 9, 2009

Pharma influence on patient advocacy

NAMI exposed: the drug money behind this supposedly grassroots group - blog post by Alison Bass.

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Merck, young journalists, and conflict of interest

The Vioxx story won't die.

From Australia:

SCIENTISTS were allegedly recruited by a pharmaceutical giant (Merck) to put their names on research done by the drug company to promote the safety of its anti-arthritis drug Vioxx.

Wonder if this continuing international tragedy will be discussed as students from 13 major universities in the United States and Canada meet at Rutgers this week for a three-day conference on the subject of science journalism - sponsored by the Merck Company Foundation. Of course, they will tour Merck’s research labs and hear from Merck execs. Rutgers says “Students will each receive a $1,000 scholarship for attending and a plaque commemorating their participation in the program.”

One former pharma exec wrote this to me: “I'd say that this "program" rates the equivalent of wining and dining doctors and their wives and then giving them a lecture on their new drug. Toss in a "reminder" gift.”

This is getting the students’ training in conflict of interest off to a rip-roaring start!

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April 8, 2009

Will the Minnesota med school ever recognize a COI problem?

See med student Josh Lackner's column in the Minnesota Daily.

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April 3, 2009

News about Gooz is our loss

Merrill Goozner, who headed the Integrity in Science Watch project at the Center for Science in the Public Interest for the past five years, has been axed by CSPI.

The good news is that he'll now have more time to devote to his terrific blog, GoozNews.com, for which, in the past, he had to cobble together an hour or two in the morning or an hour or two in the evening - or more - to fuel the blog. Or maybe he'll come up with a new initiative worth watching. He won't sit still - although he says a few rounds of golf will come first.

Gooz helped put health care conflict of interest on the public radar screen during his five years at CSPI. He has an eye and an intellect to hone in on troublesome tidbits that others may miss. We can't lose his regular contribution to journalism in whatever form that takes.

We wish him the best.

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March 30, 2009

Required reading on industry-funded CME

A devastating indictment. That's what Dr. Daniel Carlat - on his blog - called yesterday's piece in the Milwaukee Journal Sentinel, “Drug firms' cash skews doctor classes: Company-funded UW courses often favor medicine, leave out side effects.”

I'm late in weighing in on this, so I'll just refer you to Carlat's analysis.

But I will add this: somehow that little paper in Milwaukee continues to publish top-notch tough investigative health care journalism and their readers should appreciate what they're getting while they're still getting it. This story was more than 2,500 words of important news - not the usual 300 word drivel trumpeting breakthroughs from the medical journals. Carlat said "Occasionally, a piece of investigative journalism sets into motion processes that strike corrupt business practices at their core. ...it will become required reading for all those involved in health care policy."

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March 19, 2009

More UMN psychiatry ethics questions surface

I'm on the road, but I see that the Twin Cities papers and blogs are buzzing over new questions of conflict of interest in the University of Minnesota Medical School and specifically in the department of psychiatry.

The Star Tribune reports:

"In the spring of 2000, Dr. S. Charles Schulz attended a national medical conference to present favorable research on a new psychiatric drug called Seroquel. Schulz, chief of psychiatry at the University of Minnesota, reported that the drug was 'significantly superior' to the old gold-standard treatment for schizophrenia. In a press release by the manufacturer, AstraZeneca, he touted the 'dramatic benefits' of Seroquel's class of drugs. But newly released documents show that AstraZeneca knew the research didn't support the claim -- and knew two months before Schulz went public with it.

The disclosures have raised questions about Schulz's ties to the company as a paid consultant at a time when Congress and the university itself are intensifying their scrutiny of potential conflicts of interest in medical research."

The Pioneer Press story is here.

Dr. Frank B. Cerra, Sr. Vice President for Health Sciences at the UMN has an online statement:

"We are clearly operating in a new and different era of accountability, as is apparent from banking issues in New York and appointment issues in Washington in recent days.

For us, in the Academic Health Center this intense concern for accountability is somewhat familiar – with a new and different lens. We’re accustomed to the NIH environment where research grants have clear expectations for performance. And, as a public institution, we regularly report to the Minnesota legislature about our activities and outcomes. And it appears that the federal stimulus funding coming to Minnesota will add another layer of reporting, or accountability to ensure the University spends those dollars wisely.

In the midst of this heightened scrutiny, the media continues to focus on issues of conflict of interest as we publicly wrestle with developing new policies or procedures to manage the industry relationships necessary to bring new discoveries to the public and the marketplace

I’d like to make a couple of points loud and clear, as I have publicly on several occasions. Yes, the faculty within the Academic Health Center – and indeed in other parts of the University – have relationships with industry. Our new ideas, our discoveries would never go anywhere if there weren’t a company willing to develop or manufacture the results of our work. And then those discoveries would never make it into the marketplace to both improve and enhance care and health. Yes, pharmaceutical and device manufacturers pay for clinical trial work taking place at the University. There is no other source of funds. And, yes, our faculty – physicians, pharmacists, dentists and others – are compensated for their time and work.

Our job, as University administrators, is to ensure that those relationships are appropriately disclosed and appropriately managed, so that the public retains its confidence in our institution and its work. That’s accountability that’s critical for today and tomorrow."

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March 13, 2009

Well-deserved journalism award on clinical trial ethics story

St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto have been awarded a Frank Premack Public Affairs Journalism Award for their series on the death of Dan Markingson in a clinical trial at the University of Minnesota.

The Premack judges wrote: “Through the eyes of one patient, this story shed considerable light on the complicated and competing interests between the development and path to market of new drugs, funding needs of the University and the integrity of medical research. The judges are hopeful that the new ethics task force implemented at the U of M is resulting in changes in conflict of interest policies.”

Also this week, Professor Carl Elliott of the University of Minnesota Center for Bioethics published an editorial in the Pioneer Press, "Create counterweights to the influence of money on drug studies," regarding the Markingson story. In it he concludes:

"Any serious attempt to clean up industry-sponsored research must do at least two things. First, it must minimize the internal pressure faced by researchers to raise money for their departments. Second, it must eliminate the external financial incentives that lead researchers to recruit patients into studies instead of giving them proven treatment. Unless these conflicts of interests are eliminated, universities will continue to repeat the mistakes that preceded the death of Dan Markingson."

Congratulations to Olson, Tosto, and the Pioneer Press for this terrific investigative piece. Kudos to Professor Elliott for addressing the ongoing ethical issues in clinical trials.

We can't lose this kind of important contribution in daily journalism at the local level.

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March 4, 2009

Med student's editorial on conflict of interest

Read what Minnesota med student Josh Lackner wrote in the Minnesota Daily about his frustration with the "substantially diluted" UMN med school COI policy now being pushed through the system.

If he ever gives up on medicine, we should find a place for him in journalism.

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February 7, 2009

BMJ reminds docs: It takes two to tango with pharma

The BMJ this week states:

The relationship between the drug industry, academia, healthcare professionals, and patients has reached an all time low and few doubt that it is in the interests of all parties to improve it. A recent report from the Royal College of Physicians attempts to define a path towards achieving a more productive relationship. Here we set out five contrasting views on what the ideal relationship between industry and prescribers and patients should be and what steps need to be taken to achieve it.


Editor Fiona Godlee writes:

"As our cover image shows, it takes two to tango. It’s time for the profession to take a lead. This means saying no to gifts and hospitality, ensuring that research and clinical collaborations are transparent and unbiased in their design and reporting, refusing to be a guest or ghost author, declining the role of paid opinion leader, paying our way for information and education, and refusing industry support unless it is entirely transparent and in patients’ or the public’s best interests."

Former New England Journal of Medicine editor Marcia Angell writes:

"I believe there should be no relationship between the drug industry and either prescribers or patients. Drug companies are investor owned businesses with a responsibility to maximise profits for their shareholders. That is quite different from the mission of the medical profession, which is to provide the best care possible for patients. I start with this simple fact, because it is so often obscured by the industry’s public relations. ...We need to stop accepting the fiction that marketing, whether to prescribers or patients, is good education."

And Harlan Krumholz and Joseph Ross propose six standards to restore trust:

1. dispense with promotional activities such as direct to consumer advertising and distribution of drug samples in settings where prescribing decisions are made.

2. forgo gifts.

3. clinicians, researchers, academic institutions, clinics, and hospitals must disclose all payments and gifts from industry, regardless of size or whether they were paid directly, through a third party, or to a charity or other organisation.

4. industry sponsorship of continuing medical education must stop because it diminishes credibility regardless of its quality.

5. industry sponsored clinical studies should be visible, accountable, and comply with mandatory standards set by institutional review boards, data safety and monitoring boards, and steering committees to protect patient volunteers. In addition, external investigators should receive the study’s raw data and rights to publication. Seeding trials and ghostwriting should be prohibited. Trials should be publicly registered and their results should be posted within two years of completion regardless of peer review publication. Registration should include naming members of the data safety and monitoring board and steering committee (which is ideally composed of non-employees), investigators, and pre-specified data analysis plans including primary and secondary outcomes.

6. let’s accept divergent views, defend free speech, and acknowledge that there is great value in the respectful exchange of ideas. We need to overcome an unfortunate history of intimidation exhibited by some companies against physicians who have expressed opinions that did not favour their product. We also need to eliminate efforts by opinion leaders at some academic centres to leverage funding from companies in exchange for favouring industry products or neutralising critics.

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February 2, 2009

Will Boston lose business due to medical conflict-of-interest laws?

Or is just fear-mongering on the part of industry and special interests?

The Boston Globe and blogger Alison Bass have written about the new Massachusetts "state's regulations, which establish a code of conduct for pharmaceutical company employees, will limit participation by drug company scientists in meetings and continuing medical education courses in Massachusetts." As a result, some medical groups are threatening to move their medical conferences out of Boston.

Blogger Bass writes:

"All three of the medical societies named in the (Globe) article -- The American Academy of Allergy, Asthma and Immunology, the American Society of Gene Therapy and the Heart Rhythm Society -- have received major funding from the pharmaceutical and medical device industry over the years.

Hmmm...could it be that the pharmaceutical and medical device industry had something to do with these rather unsubtle threats?

Spokespeople for two of the groups quoted in The Globe article said they were concerned that the proposed guidelines won't allow presentations by drug company employees at meetings in Massachusetts. According to local public health officials, that's simply not true. The regulations do allow company scientists to present at meetings but the presentations must be objective and cannot be used to flagrantly promote company's products. What a marvelous concept -- and a major departure from business as usual.

One need only visit the medical groups' websites to see the extent of industry funding behind these groups. In the March 2008 annual meeting program of the American Academy of Asthma, Allergy and Immunology, for example, the list of commercial supporters filled a full page, ranging from pharm companies such as GlaxoSmithKline, Merck, Schering Plough and AstroZenica to biotechs like Sepracor, Genentech and Teva Specialty.

Likewise, the Heart Rhythm Society's list of supporters for its May 2008 meeting in San Francisco includes all the major makers of cardiac medical devices: Medtronic, Boston Scientific and sanofi aventis (labeled Diamond Level sponsors), Boehringer Ingelheim (an Emerald Level Sponsor) and Biosense Webster, a subsidiary of Johnson and Johnson (alas only Ruby Level).

Similarly, the American Society of Gene Therapy listed Genzyme as its "partner" for its annual meeting last May in Boston and 15 biotech and medical device companies as major contributors and patrons.

So if The Boston Globe really wanted to do its homework, it could ask these three medical groups just how much money all this corporate sponsorship translates into every year and what kind of pressure the industry put on them to howl about regulations that were, by the way, designed to protect consumers."

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January 29, 2009

Did handling of med school conflict of interest issues lead to this change in administration?

Professor Bill Gleason has posted on his blog the contents of an e-mail memo that announced that the University of Minnesota would "combine the position of Senior Vice President for Health Sciences with that of Dean of the Medical School. ... We are indebted to (medical school) Dean Powell for her leadership over the past several years. She and I are working together on transition issues and discussing a future administrative role for her in the area of medical education."

I've already had one reporter call me asking if I would tie this announcement to the recent controversy, reported by the Star Tribune, that Powell "appointed as cochair of the task force (on med school conflict of interest policy) a man who'd just come off three years of sanctions for his own serious conflict-of-interest violations involving a private company he owned."

How would I know?

I was on the task force and didn't even know the history of the events in question!

The thought crossed my mind when I heard the news, but U hierarchy hasn't shared any such info in my in-box recently.

And, no, I don't know what has happened or will happen with the task force recommendations, which took almost a year to draft.

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January 26, 2009

Milwaukee paper keeps hammering on conflict of interest

The Milwaukee Journal Sentinel has done it again.

This tough "medium market" (if I can call it that) newspaper faces tough economic times by scrapping to do more tough journalism. Just two weeks ago we blogged about one of their stellar health journalism efforts.

Yesterday they published a 1,700-word story (that's rare these days) raising more conflict of interest questions at the University of Wisconsin medical school. It begins:

The conclusions were clear: Women who took hormone therapy drugs were at increased risk for breast cancer, heart disease, stroke and blood clots.

The findings were so strong that researchers stopped a clinical trial in 2002, five years early, because it would have been unethical to continue giving the drugs to women.

But that same year, the University of Wisconsin-Madison's School of Medicine and Public Health began a medical education program for doctors that promoted hormone therapy, touted its benefits and downplayed its risks.

For the next six years, thousands of doctors from around the country took the online course that was funded entirely by a $12 million grant from Wyeth Pharmaceuticals, which makes the hormone therapy drugs used in the study, Prempro and Premarin.

The university received $1.5 million of that total, and university faculty received money as well.

Even after the course was no longer available, the Web site and course material remained on the Internet, accessible to consumers and doctors. The university dropped the site Jan. 15, one day after the Journal Sentinel began questioning UW officials about the propriety of the program.

The influence of drug companies on doctors - and, by extension, medical schools - is coming under increased scrutiny, with critics saying programs like the UW one are essentially marketing exercises.

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January 24, 2009

Spine surgeons group toughens disclosure policy

The Wall Street Journal reports today:

A medical society representing U.S. spine surgeons has taken the rare step of requiring that researchers disclose not just the existence of financial ties to medical-device companies, but the dollar amounts as well.

The initiative is a response by the North American Spine Society to pressure from lawmakers, prosecutors and lawsuits by companies' former employees. Prominent surgeons doing research have been found to have significant financial relationships -- sometimes to the tune of millions of dollars -- with medical-device firms.
The society said its policy "is not a voluntary guideline, but a binding covenant which applies to all relationships engaged in by all participants in all" activities of the spine society. Failure to disclose would be a "sanctionable offense," the spine society said. Sanctions could include suspension, expulsion or public letters of censure. NASS sanctions wouldn't have any effect on a doctor's ability to practice, only on membership in NASS.
In recent years, medical-implant makers Zimmer Holdings Inc., Stryker Corp., the DePuy orthopedics unit of Johnson & Johnson, and Biomet Inc. have paid more than $221 million to surgeon "consultants," according to a Senate committee.

Medtronic Inc. has been accused by former employees and the government of inducing surgeons to use its spine products through questionable payments. In 2006, the Minneapolis company agreed to pay $40 million to the government to settle civil charges in federal court in Memphis, Tenn., that it paid kickbacks to doctors, but denied wrongdoing.

The NASS disclosure policy is available online (although it is not immediately clear if what's posted is the latest version.)

I can't help but think that only a few days ago I blogged about the "gaping holes in medical school disclosure policies that didn't require the actual dollar amount of financial ties to be disclosed. And a Minnesota orthopedic surgeon commented in response to my blog posting:

"Please Mr. Schwitzer, pursue the whole story and not just the attention grabbing, tabloid headlines. People deserve to know the whole truth, ever (sic) if it sells less well than tabloid journalism."

It looks like surgeons like him shouldn't just be writing to little bloggers like me. They may want to start writing to their own professional organizations (like NASS), to Senator Grassley, to journal editors, and to all the other boogeymen out there.

BTW, I don't make anything from this blog. You don't see any ads. I'm not paid to do it.

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January 23, 2009

UMN med school prof tired of "foot-dragging" on conflict of interest policy

A University of Minnesota medical school professor who calls himself "The Whining Dinosaur" on his blog has stirred up the med school conflict-of-interest policy discussion again with an editorial in the Minnesota Daily.

I go out of town for a day and he stirs things up partially by using some of my comments as the stirring spoon!

That's OK.

I stand by what I said. And, while he said some nice things about me in the editorial, I also applaud how he writes to keep these issues alive - for whomever we reach in this little blog world.

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January 20, 2009

Patients unaware of docs' conflicts of interest

Close on the heels of the WSJ story last week that exposed gaping holes in med school conflict of interest policies comes this article in the Medical Journal of Australia.


To seek the views of patients attending general practice about doctors’ interactions with the pharmaceutical industry and their wishes for disclosure of this information.

Design, setting and participants:

906 patients attending three general practices in metropolitan Sydney during October –November 2007 completed an 18-item anonymous survey exploring their perceptions of doctors’ competing interests.


Most patients (76%) were unaware of any relationship their doctor may have with pharmaceutical companies. Patients wanted to know if their doctor obtained any benefits in cash or kind from the pharmaceutical industry (71%), financial incentives for research participation (69%) or sponsorship to attend conferences (61%). Most agreed that disclosure of competing interests by doctors is important (84%), believing this disclosure would help patients make better informed treatment decisions (78%). Eighty per cent of patients stated that they would have more confidence in their doctor’s decisions if interests were fully disclosed, with strong support for verbal disclosure during the consultation (78%).

Patients are currently not aware of their doctors’ competing interests but do want to know of doctors’ interactions with the pharmaceutical industry, indicating that disclosure of competing interests would improve their confidence in doctors’ decisions.

(Thanks to Elena Pasca of the French Pharmacritique blog for this tip!)

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January 17, 2009

Gaping hole in med school conflict of interest policies

$20,000 or $20,000,000. Come on, it's just a difference of a few zeroes!

The Wall Street Journal story, "Medtronic Paid This Researcher More than $20,000 - Much More," should not be missed.


Spine surgeon using Medtronic devices takes money from Medtronic.

How much money?

His university medical center only required him to say whether it was $20K or more a year.

So for five years he declared that "YES" he got more than $20K a year.

Disclosure policy satisfied, right?

It's just that the "more than" was astronomically MORE THAN - like up to $4.6 million in royalty and consulting payments a year, according to the WSJ.

The paper quotes the surgeon's med school dean agreeing that its disclosure requirements are insufficient and “indefensible.?

The WSJ reports that the surgeon says he doesn’t accept royalties on products used on his patients, and that since 1991 he has told patients about his royalty and consulting relationships.

Perhaps it should be made public exactly how that disclosure to patients is handled. I can't imagine.

"I have received $19 million in payments from a company to help develop and promote their products but that hasn't influenced my judgment in the least and I think this is the best product for you. Now, see my nurse to schedule the surgery."

We are all babes in the woods in our grasp of how complex the entanglement of conflicts of interest are in American health care.

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January 13, 2009

Are doctors loyalties divided?

The Milwaukee Journal - a paper facing all the struggles (and maybe some more) that any news organization faces - continues to shine through it all with its health news coverage.

Reporter John Fauber has a two-part series this week on "doctors moonlighting for drug companies." Excerpt:

It's a practice that increasingly is drawing criticism because of concerns that it can influence patient care and raise the cost of treatment, in addition to blurring the line between research and marketing.

The deans of the state's two medical schools say they would like to ban the practice or severely limit it.

"I am very bothered by our faculty using our school's name in giving non-academic promotional, marketing talks," said Robert Golden, dean of the UW medical school. "It's a major issue we are talking about now."

In October, the Wisconsin Medical Society, as part of its recommendations for ethical behavior, said doctors should not serve as speakers. The group has no authority to regulate or stop the practice.

See part one.

And part two.

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December 29, 2008

How NOT to handle conflict of interest disclosure

The Star Tribune did a fine job digging, finding and disclosing that Dean Deborah Powell of the University of Minnesota medical school "appointed as cochair of the task force (on med school conflict of interest policy) a man who'd just come off three years of sanctions for his own serious conflict-of-interest violations involving a private company he owned." As a Strib editorial correctly stated: "Had it not been for the newspaper story, made possible by documents obtained through the state's open records laws, neither the public nor some members of the panel would have known of Leo Furcht's past."

Blogger Bill Gleason posted the Strib article and has commented on the events.

Blogger Margaret Soltan "proposes we call this the Hannibal Lecter Executive Strategy. Not only was Lecter, as an object of FBI interest, experienced in the Bureau’s flaws. As someone who killed and ate people, Lecter had an insider’s understanding of other people who kill and eat people."

I was asked by the dean to serve on that task force.

I never thought I would have to poll fellow task force members about their own past or present conflicts of interest, so I didn't.

No one ever told task force members - at least not me - about the history of Furcht and Powell. Maybe everyone else knew. But I was the outsider on this task force - the journalism guy from across the street.

I am disappointed and feel misled. I'm not sure that knowing these details up front would have changed anything about the task force report. But I do know I'd feel a lot better about the process had there been full transparency and disclosure up front - which is at the core of conflict of interest policies.

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December 1, 2008

Conflict of interest on NPR's "On the Media"

NPR's "On the Media" program this weekend looked at drug industry influence on media messages, including an interview with Senator Charles Grassley about his investigations of the industry.

The program also featured an interview with me about our HealthNewsReview.org project and about other issues involving health care news sources' conflicts of interest.

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November 20, 2008

Entanglement of medical journalists & Big Pharma

In the BMJ this week, Steve Woloshin, Lisa Schwartz and Ray Moynihan raise new questions about "who's watching the watchdogs?" Excerpts:

"Industry sponsorship of training and further education of journalists now occurs in a variety of contexts—universities, conferences, and professional associations—raising similar concerns to those that apply to education of doctors.

The University of North Carolina’s master’s degree in medical journalism, one of the first in the United States, has at least two important forms of financial relations with drug companies. ...

Like some university programmes, the American Medical Writers Association, whose members include reporters and public relations specialists, receives sponsorship from the drug industry. Eli Lilly was a key sponsor of the association’s 2008 annual conference, and the company also sponsors its student scholarships.
One of the more astonishing forms of financial ties between journalists and drug companies is the sponsored award, which often involves lucrative cash prizes or opportunities for international travel. For example, Eli Lilly and Boehringer Ingelheim have co-sponsored an award for "reporting on urinary incontinence," carrying a prize of international travel. Boehringer has an award for reporting on "chronic obstructive pulmonary disease," offering prizes worth $5000 each, Eli Lilly one for reporting on oncology, and Roche one for "obesity journalism," with a prize of $7500. Sometimes awards are sponsored by organisations that are themselves heavily funded by industry, such as the non-profit Mental Health America. Its 2007 annual report shows that almost half of its funds came from drug companies, including more than $1m each from Bristol Myers Squibb, Lilly, and Wyeth.
A powerful contemporary example of entanglement involves a television network called Accent Health (whose logo includes the words "Your target is waiting"), said to be watched monthly by more than 10 million viewers in US medical waiting rooms. The network, which is produced by CNN, overtly offers sponsors, including drug companies, the chance to boost sales of their products, by, for example, putting "your brand in front of the valuable Baby Boomer population just before they discuss their health conditions with their doctor." One of the hosts is Sanjay Gupta, CNN’s chief medical correspondent and host of at least one other CNN health programme that is funded partly through drug company advertising. ...

As researchers and writers acting to improve medical journalism, we encourage journalists, educators, and professional associations to scrutinise their own relations with the industry as intensely as they do those between doctors and drug companies and to develop workable solutions. And, if they are to be good watchdogs, journalists need to mark their territory and clearly establish boundaries between themselves and the industry to avoid unhealthy entanglements.


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November 4, 2008

Definitions are everything with conflict of interest

Sandy Szwarc, on her Junkfood Science blog, posts an example of conflict of interest disclosure - or is it?


• a journal article touting the high benefit-risk ratio of statins
• the author states he's been a consultant to four statin makers
• disclosure ends with a statement "There are no conflicts of interest."

See and judge for yourself.

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October 27, 2008

Badger docs ban gifts

Thanks to Merrill Goozner for tipping me off on this one. The Wisconsin Medical Society’s ethics policy states that physician members “shall accept no gifts from any provider of products that they prescribe to their patients such as personal items, office supplies, food, travel and time costs, or payment for participation in online (CME) continuing medical education. A complete ban eases the burdens of compliance, biased decision making, and patient distrust.? Further:

The direct provision of drug samples to patients should be limited and, when possible, should be replaced by a system of vouchers for evidence-based drug choices.

Physicians serving on formulary committees who have any kind of commercial relationship with a health product company shall disclose any such relationship and recuse themselves from the formulary process, as necessary to avoid bias.

CME providers should not accept support from health product companies directly. A CME provider may create a fund for medical education that may accept unrestricted donations from health product companies that is then dispersed according to institutional policy; this policy, financial contributors and the amount of their contributions shall be disclosed as public information on an easily accessible Web site.

Physicians should not serve as members of speaker bureaus for health product companies or their contractees.

Physicians should not allow their names to be listed as authors for articles written by health product company employees, a practice called “ghostwriting.?

Since ethical collaboration between the profession and the health product industry is essential for the continued development of health products, high-integrity consulting and research relationships shall be strongly encouraged. However, to avoid such relationships being tantamount to a gift, such relationships shall be based in contracts for specific “deliverables? in return for just compensation.

The following office sign is available for members of the Wisconsin Medical Society:
Office Sign:
To uphold the highest standards of our Profession,
To ensure our advice is based solely on what’s best for you, and
To enable your highest level of trust in our advice,
We follow the recommendations of the Wisconsin Medical Society,
And accept no gifts from any provider of a product that we prescribe or recommend to you.

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October 20, 2008

Entanglements of conflicts of interest in health care news

The Integrity in Science Watch project of the Center for Science in the Public Interest, in this week's e-newsletter, has two different but related "jeers" for failure to disclose conflicts in two different health journalism efforts. Their posting:

Jeer to the National Press Foundation for an omission on its agenda for the Oct. 23 forum for journalists on “The New Understanding of Pain,? which was funded in part by the unit of Johnson & Johnson that makes pain medications. The agenda does not disclose that presenters Howard Heit of Georgetown Medical School and Aaron Gilson of the University of Wisconsin have consulted for Purdue Pharma, maker of the controversial pain medication OxyContin, and other manufacturers of pain medications.

Jeer to Erik Eckholm and Olga Pierce of the New York Times for failing to disclose in an August 15, 2008 article on methadone risks that Howard Heit of Georgetown Medical School, who is quoted warning about those risks, has served as a consultant for Purdue Pharma, maker of OxyContin, a rival drug.

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October 14, 2008

And now, your league leader in conflicts of interest.....

If you're not aware of, or haven't kept up on, the story of psychiatrist Charles Nemeroff, read Judith Warner's piece, "Diagnosis: Greed."

She says that Nemeroff...

"...violated federal research rules regarding conflicts of interest and made millions of dollars consulting for the pharmaceutical industry.

Yet the story of Nemeroff, who earned $2.8 million in fees from 2000 to 2007, and had at one point consulted for 21 drug and device companies simultaneously, wasn’t really a departure from the news of the week – or of this whole benighted era – at all.

It was, rather, yet another iteration of the ever-unfolding saga of greed and how the deregulation of absolutely everything has brought our country to this painful season of reckoning. Because Nemeroff’s story – which is hardly unique – belongs uniquely to this time in our nation’s history.

It is a product of legislative and cultural changes that have altered the practice of medicine, the work of research universities and the relationship between those universities and industry. And it is marked, like so much of what’s gone off the rails in our era, by the failure of our government to step in to protect citizens."

Also see Ed Silverman's blog entries:

"Your Speaker This Evening, Dr. Charles Nemeroff."
"What Rules? Emory Fiddled While Nemeroff Earned."

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September 11, 2008

Hospital ad pressure on a newspaper?

CJR's column, "Something's Rotten in Roanoke," raises some important questions, although it doesn't answer any of them.

It is clear that the once formidable wall that once stood between the advertising departments and the news departments now looks like Swiss cheese in many news organizations.

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September 9, 2008

Doctors, dollars and devices - Strib series

The Star Tribune today concluded a three-part series on financial conflicts of interest in the spine surgery/medical device industry. Nice job reporting on things all consumers should know more about.

Part 1: Medical device payments to doctors draw scrutiny

Part 2: For companies courting surgeons, how far is too far?

Part 3: Will disclosure affect flow of cash?

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August 6, 2008

You can find conflict-free experts in health care, medicine and science

We've posted the following Publisher's Note on HealthNewsReview.org.

Conflicts of interest among sources of health/medical news and information represent an enormous – and growing – problem.

Health care consumers, and news consumers, are often not told of the biases that may exist in medical research, in clinical care, or in health care professionals’ continuing medical education because of financial ties to drug companies and medical device manufacturers.

Journalists, broadcasters, editors, and producers too often rely – wittingly or unwittingly – on drug industry sources. The result: medical news often helps sell drugs to the public, accentuating the positive and minimizing risks, rather than giving readers a balanced, accurate view.

To counter claims that it is impossible to find experts who are not on the payroll of industry, independent journalists Jeanne Lenzer and Shannon Brownlee have compiled a list of more than 100 experts from several nations with expertise across a wide range of disciplines. There are two parts to the list. One part includes experts who have no financial conflicts of interest, or conflicts that are irrelevant to most stories. The second part includes experts with a variety of potential conflicts. Some of these experts have ended their pharma ties – but only within the past five years. Others may have current financial conflicts of interest. These experts, despite their commercial ties, are included in the list because they have provided important insights into the inner workings of industry – effectively biting the hand that fed them in some instances --and/or because their conflicts did not limit their ability to comment in areas unrelated to the conflicts.

The experts include: two former editors of the New England Journal of Medicine, the former editor of the western journal of medicine, current editors of American Family Physician and Public Library of Science-Medicine; former FDA advisors; physician educators; researchers; bioethicists; epidemiologists, methodologists, geneticists, and clinicians from a various specialties; medical whistleblowers; and several medical journalists.

Information about the list appears in the “Journalist Toolkit? section of the site at: http://www.healthnewsreview.org/independentexperts.php. If you’re a journalist, you’ll be given instructions about how to acquire the list, complete with experts’ contact information. The general public will be able to see the list of names without any contact information.

It’s our hope that this list helps journalists find and use sources who do not have financial conflicts of interest. We hope that the general public understands the gravity of these issues and their impact on the integrity of medical science.

For further information on the list see: Naming Names: Is There an (Unbiased) Doctor in the House? BMJ July 23, 2008.

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July 30, 2008

More MRI & imaging centers - do we ever say "NO"?

A few days ago, the Star Tribune reported on plans for still another diagnostic imaging center in a Minneapolis suburb that has more MRI machines than in many entire countries. Excerpt:

Along a two-mile stretch of France Avenue in Edina, medical providers have installed so many powerful magnetic resonance imaging (MRI) scanners that radiologists joke that anyone driving through with a pacemaker should beware.

Come September, there'll be a new one. ...

Its opening is likely to reignite a debate on whether Minnesota has too many diagnostic imaging facilities, encouraging doctors to order unnecessary procedures and pushing up medical costs. It's also likely to raise the ethically thorny question of whether doctors should refer patients to a facility in which they have a financial stake.

"Imaging has been an area of concern for a long time," said Julie Sonier, director of the Minnesota Department of Health's health economics program, which does reviews of major medical investments. "Issues about the concentration in Edina have also been a concern for some time."

A 2007 Health Department report said there was anecdotal evidence in Minnesota that physician investments in facilities led to financial conflicts of interest and overuse.

Among the reader responses are these:

• As a patient, how do you know that you really need a test that may be uncomfortable, that might have some risk associated, that might have radiation exposure associated, and that you might have to pay for when you know that the person telling you you need it stands to make up to $1000 just for suggesting it? The answer is you can't. This practice is a pox on medicine.

• There are as many MRI scanners in the Twin Cities as in all of Canada. Is the health of Canadians compromised by fewer imaging studies? Obviously not. There is no relationship between the number of tests and procedures performed in medical care and the health outcomes of the patients. More medical care is not better care. The Health Department should carefully examine the merits of this expansion of imaging services.
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July 11, 2008

Reax to PHRMA's toothless code of ethics

AP reports:

Dr. Brian Hurley, president of the American Medical Student Association, said the new rules are an improvement but they don't go far enough. He said gifts given to doctors as educational materials or occasional meals are still gifts. "Aggressive" marketing practices have made drug companies a lot of money, he said, and they have little incentive to stop those tactics.

"Educational gifts or educational programming that pharma's member companies put together are marketing in disguise," he said.

The Boston Globe reports:

The Prescription Project, a Boston-based national coalition of groups that monitors pharmaceutical marketing, released a statement noting that promotional spending by the pharmaceutical industry has increased since PhRMA adopted its first guidelines on gifts in 2002. It also said that a report released this week in Vermont, one of the few states that requires disclosure of marketing payments to doctors, showed an overall 33 percent increase in pharmaceutical payments in the last year.

The Baltimore Sun reports:

"This announcement is a P.R. ploy. It really is a meaningless gesture," said Dr. Jerome P. Kassirer, a Tufts University School of Medicine professor and author of On The Take: How Medicine's Complicity with Big Business Can Endanger Your Health. Kassirer said even small gifts persuade doctors to prescribe new drugs that cost more than older treatments and may have harmful side effects because they aren't well understood yet.

The 31 pages of revised guidelines don't curtail several promotional efforts that have drawn the particular ire of critics. Left unaddressed, for example, are the fees drug companies pay to physicians for speaking to fellow doctors about diseases and treatments or for advising the companies about products and medical conditions.

Nor would the recommendations advise against the widespread practice of having company sales representatives bring breakfast or lunch to doctors' offices and then pitch new drugs during the free meals.

"It's best for consumers if there's competition around price and not competition around influence, reciprocity and advertisements, and I don't think we see that here," said Dr. John Santa, director of Consumer Reports' health ratings center.

The Wall Street Journal reports:

Sidney Wolfe, director of the health research group at Public Citizen, a consumer organization, said the new code of conduct, like other transparency initiatives, is a "thinly disguised PR effort." He added that such codes are toothless and that "there's not going to be a serious effort to detect violations."

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July 10, 2008

Drug industry move that doesn't go far enough

This just in on a move that, on the surface, doesn't go nearly far enough.

Bloomberg reports:

The U.S. pharmaceutical industry revised its code of conduct, banning gifts to doctors such as pens, mugs and restaurant meals. The drugmakers may still provide food to physicians in their offices, and pay them speaking and consulting fees.

Drugmakers' salespeople may provide ``occasional meals'' in offices of health-care professionals ``in conjunction with informational presentations,'' the Pharmaceutical Research and Manufacturers of America said today in a statement on PR Newswire. The Washington-based lobbyist group also issued more detailed standards on continuing education and disclosure of speaking or consulting fees.

Relations between drug companies and doctors, including medical researchers, have come under scrutiny in Congress. Senator Charles Grassley, Republican of Iowa, criticized payments from Johnson & Johnson and Eli Lilly & Co. to Harvard Medical School doctors who helped pioneer the use of psychiatric drugs in children.

The new code, scheduled to go into effect in January, 2009, ``is part of an ongoing effort to ensure that pharmaceutical marketing practices comply with the highest ethical standards,'' the pharmaceutical association's statement said.

More on this later.

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July 3, 2008

"No Drug Reps" certificate for your door

PharmedOut.org, a project run by Dr. Adriane Fugh-Berman of Georgetown University Medical Center, now posts online a certificate which doctors can use to declare their independence from industry influence. Fugh-Berman says, “The certificate will help patients choose physicians who depend on evidence rather than marketing.? The certificate helps physicians as well, adds Fugh-Berman, because it explains to patients why drug samples are not available. “Patients love free samples,? notes Fugh-Berman, “but samples are the single most effective marketing tool pharmaceutical companies have. Once patients start a drug, they usually stay on it, and samples are usually for expensive drugs that are prescribed for chronic conditions.?

The PharmedOut.org site offers other related resources:

Help Your Doctor Break the Sample Habit

Fast Facts on Generic Drugs (pdf file)

Fugh-Berman A, Ahari S. Following the Script: How Drug Reps Make Friends and Influence Doctors. PLoS Medicine; April 2007;(4)4:e150.

The Physician-Pharma Relationship (slideshow)

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June 30, 2008

The $6 Million Dollar Researcher

The story of Stanford psychiatry chief Alan Schatzberg, his ownership of $6 million in stock in a drug he's investigating, Senator Charles Grassley's letter to the university, and the university's response is too good to miss.

Journalist Ed Silverman has blogged about it.

So has psychiatrist Daniel Carlat. Excerpt:

"I do find it incredible that Stanford finds it acceptable for him to serve as the chairman of an academic department. As chairman of psychiatry, Dr. Schatzberg is involved with many decisions having to with hiring staff and funding research. While I have no doubt that he is an ethical person, the fact that he owns $6 million in stocks can never be far from his mind. If it were me, I'd be thinking about it when I woke up in the morning, during my coffee breaks, my meals, and while I was brushing my teeth at night. We're talking $6 million here, people.

He doesn't have the cash yet. He will only be able get it if his company issues a successful IPO, and that will happen only if his drug, mifespristone, looks successful. Here are some problematic possible scenarios. A young professor in his department is up for promotion. But he is researching a medication in direct competition with mifepristone. Dr. Schatzberg has to make a decision, knowing that this could have an eventual impact on his ability to retire with $6 million.

Another scenario. A psychiatry resident has written a wonderful review paper on antidepressants which has been submitted for a departmental award. In it, the resident has concluded that mifepristone is not a promising agent. Schatzberg has to decide who will get the award.

Equally amazing to me is the American Psychiatric Association has no policy forbidding this level of conflict of interest in candidates for APA president. Shatzberg won the most recent election, and will be installed as APA president next May. What will happen if and when Dr. Schatzberg is asked to make decisions regarding the appropriate relationships between the pharmaceutical industry and the organization?

Let Dr. Schatzberg have his pharmaceutical company. But his financial entanglements are far too significant to have him entrusted to positions of leadership at major institutions.

Making tough decisions is part of life, and Dr. Schatzberg needs to decide between being a tycoon and an educator. He can't have it both ways."

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June 29, 2008

To hell with evidence

Read this terrific piece of journalism in the New York Times - "Weighing the Costs of a CT Scan's Look Inside the Heart."

It analyzes important questions about the lack of evidence for these tests, the costs, the radiation risks, and the conflicts of interest of many who promote them.

The story includes a quote from a physician who is a heart CT scan promoter - "It's incumbent on the community to dispense with the need for evidence-based medicine."

To hell with evidence. To hell with science.

This attitude always reminds of me of the saying, "It ain't what a man don't know that gets him into trouble. It's what he knows for sure that just ain't so."

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June 23, 2008

Key opinion leaders not in the public interest?

Journalist Ray Moynihan reports on the role of the influential experts paid by industry to help "educate" the profession and the public. Excerpt:

In the world of medicine, "key opinion leader" is the somewhat Orwellian term used to describe the senior doctors who help drug companies sell drugs. These influential doctors are engaged by industry to advise on marketing and help boost sales of new medicines. Across all specialties, in hospitals and universities everywhere, many leading specialists are being paid generous fees to peddle influence on behalf of the world’s biggest drug companies.

Read the article and listen to the video clips with former drug rep Kimberly Elliott.

Moynihan's concluding quote:

David Blumenthal, a Harvard University researcher who has studied the relationships between industry and the profession, says company payments to key opinion leaders, rather than being corrupt, are simply not in the public interest. "I think these are legal relationships between consenting adults who have overlapping interests that are not consistent with the interests of the larger society or necessarily with the patients served by these physicians." Blumenthal is part of a small but growing global chorus, which includes advocacy groups No Free Lunch and Healthy Skepticism, that is calling for a major winding back of industry influence over the medical profession and in particular its education.

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June 18, 2008

Tracking conflict of interest news coverage

From time to time, I've highlighted how the Integrity in Science Watch project of the Center for Science in the Public Interest tracks news coverage (or lack thereof) of conflicts of interest in medicine and science.

This week's offering:

• Cheer to Andrew Pollack of the New York Times for disclosing that Eric L. Matteson, chairman of rheumatology at the Mayo Clinic, has consulted for many companies developing arthritis medication. Matteson is author of a recent study examining the link between various arthritis medications and cancer.

• Jeer to Audrey Grayson of ABC News’ Medical Unit for failing to note that Michael J. Manos, head of the Pediatric Behavioral Health Center at the Cleveland Clinic’s Children’s Hospital, consulted and served on the speakers’ bureaus of Eli Lilly, McNeil Consumer and Specialty Pharmaceuticals, and Shire US. Manos was quoted supporting use of pharmaceuticals to treat Attention Deficit and Hyperactivity Disorder rather than St. Johns Wort.

• Cheer to Marilynn Marchione of the Associated Press for disclosing that Michael Gnat, a professor at the Medical University of Vienna, consults for Novartis, AstraZeneca, and other breast cancer drug makers. Earlier this month, Gnat announced results of his recent study showing Novartis’ bone drug, Zometa, can slow the spread of breast cancer.

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May 15, 2008

More on school lunch panel conflict of interest

Sandy Szwarc, who does a terrific job on her JunkFood Science blog, adds to the discussion about conflicts of interest on the school lunch panel - something I blogged about two days ago.

But in her perspective:

"...industry funding is often the least of concerns when it comes to possible conflicts of interest. If your entire career has been based on the belief that obesity is due to bad foods and inactivity; if your professional reputation and status among your peers, your speaking engagements and book deals, and the grant funding you’ve brought to your university* or program have all been based on an obesity crisis and dietary behavioral interventions; if you’ve been hand-selected for a prestigious committee, sponsored by a major funder who has made obesity and diet and lifestyle interventions its key agenda; and if you are surrounded by like-minded important people — how likely do you think you would be to risk all of that by seriously questioning and objectively examining the evidence that might tumble the entire house of cards and put you on the outs in your field?
junk food basket.jpg
Right. It’s not going to happen. It's human nature.

The public has been invited by the IOM to comment on its provisional committee selection for the next 7 days week here, but it goes to the IOM committee members with even more prestigious and influential positions in line with the war on obesity. The bigger issue is that we have private vested interests funding and influencing the health policies of federal agencies and health programs that affect you and your children. Until the National Academy of Sciences cleans its own house, the public and the integrity of science-based policies will continue to lose."

She adds a very important addendum to the discussion. I don't know how she manages that prolific blog, but keep it up, Sandy.

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May 13, 2008

Conflicts of interest on school cafeteria standards panel

The Integrity in Science Watch project of the Center for Science in the Public Interest reports:

At least 8 of 14 prospective members of the National Academies of Science committee reviewing the nation’s school cafeteria standards have received recent research support from the food industry or currently receive honoraria for sitting on the board of an industry-funded non-profit, an investigation by Integrity in Science Watch showed. Just one of those affiliations was disclosed in the NAS announcement that invites the public to comment on the proposed nominations.

Recent research support for five of the proposed panelists came from a variety of industry-affiliated organizations, including the National Dairy Council, International Life Sciences Institute, National Pork Foundation, and the USA Rice Federation. Members have also worked with specific companies such as General Mills and Gerber. The committee’s proposed chairman, Virginia Stallings of the Children’s Hospital in Philadelphia, serves as president of the Dannon Institute, a non-profit housed within the Dannon Co.’s White Plains, N.Y. headquarters and fully funded by the company. Stallings received $15,000 from the Dannon Institute in 2006, according to its latest publicly available Internal Revenue Service filing. The Institute’s charitable activities include support for a Johns Hopkins University-based program to combat obesity in early childhood.

The NAS committee is funded by the Agriculture Department’s Food and Nutrition Service. It will set standards for the national school lunch and breakfast programs. NAS policy requires current conflicts of interest be disclosed to the public. The public has nine days to comment.

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May 6, 2008

Undisclosed conflicts of interest in media interviews

Jeanne Lenzer and Shannon Brownlee have a piece in Slate today that asks, "Are doctors shilling for drug companies on NPR?"

The piece begins:

"A few weeks ago, devoted listeners of National Public Radio were treated to an episode of the award-winning radio series The Infinite Mind called "Prozac Nation: Revisited." The segment featured four prestigious medical experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown.

The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine T. MacArthur Foundation, had the air of quiet, authoritative credibility. Host Dr. Fred Goodwin, a former director of the National Institute of Mental Health, interviewed three prominent guests, and any radio producer would be hard-pressed to find a more seemingly credible quartet. Credible, that is, except for a crucial detail that was never revealed to listeners: All four of the experts on the show, including Goodwin, have financial ties to the makers of antidepressants. Also unmentioned were the "unrestricted grants" that The Infinite Mind has received from drug makers, including Eli Lilly, the manufacturer of the antidepressant Prozac.

We don't know just how much funding or when the show last received it, since neither Goodwin nor the show's producers responded to repeated requests for interviews. But the larger point is that undisclosed financial conflicts of interest among media sources seem to be popping up all over the place these days. Some experts who appear independent are, in fact, serving as stealth marketers for the drug and biotech industries, and reporters either don't know about their sources' conflicts of interests, or they fail to disclose them to the public."

Disclosure: I am interviewed in the story. But don't let that stop you. The piece is worth reading.

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May 5, 2008

Conflicts of interest in psychiatry's bible group

The Integrity in Science Watch Project of the Center for Science in the Public Interests reports:

"More than half the 28 new members of writers of the next edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry. The conflicts of interests were posted online by the APA last week. They ranged from small to extensive. Leading the pack was William Carpenter, Jr., director of Maryland Psychiatric Research Center at the University of Maryland, who over the past last five years worked as a consultant for 13 drug companies, including Pfizer, Eli Lilly, Wyeth, Merck, Astra Zeneca, and Bristol-Myers Squibb. APA President Carolyn B. Robinowitz claimed that "we have made every effort to ensure that DSM-V will be based on the best and latest scientific research, and to eliminate conflicts of interest in its development." The fifth DSM, produced in conjunction with the National Institute of Mental Health, will be published in 2012. It is used by mental health professionals to classify mental illnesses."
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April 21, 2008

Drug-and-device-reps-free zone

Psychiatrist Daniel Carlat, whose blog is one of the smartest publications on the Web, recently

I've had it. As of today, I am no longer allowing drug reps into my office.

Yes, until today, I was seeing reps a few times a month for 5 minute visits in order to keep up on trends in drug company marketing techniques. But today, an Astra Zeneca rep and his district manager came in to push Seroquel for bipolar depression. They came armed with the two studies that won Seroquel its FDA approval. The studies have their limitations, but somehow these reps didn't bring these up.

Instead, what I got was a ridiculous hard sell: "Dr. Carlat, given this data, would you choose Seroquel over the other atypical antipsychotics for bipolar depression?" I asked them if Astra Zeneca had done any head-to-head studies comparing Seroquel with the others. The rep adopted a pseudo-confused look, and said, "I'm not even sure that kind of study would be ethical--would the FDA even allow you to compare an approved drug with an unapproved drug?" I pointed out that the FDA, in fact, requires that drugs be compared with placebo, the ultimate in "unapproved" drugs, and that they deem this ethical enough.

He tried another tack. "What are the symptoms of bipolar depression that you have the hardest time treating?" I said that all the symptoms are hard to treat--that, in fact, bipolar depression is a very difficult illness to treat. Out came his computer, with a slide showing that Seroquel successfully treated every one of the depressive symptoms in one study. "Now doctor, if you had a patient come into your office with suicidal ideation, and you had an agent that would help those symptoms in a week, wouldn't you want to use that agent?"

Of course I would, and there are many other agents that will work better than placebo in a week. But my rep wasn't interested in talking about the alternatives. The focus, as always, was on his product, and on his bonus.

I've printed out the National Physicians Alliance's brochure, "Why Doesn't My Doctor See Drug Reps?" and will put it in my waiting room. I'll let you know how my patients respond. For now, I'm still accepting samples (making me the most despised of doctors among drug reps, a "sample-grabber") but that will be the next to go.

Meantime, my local Star Tribune newspaper today published a story cheerleading for a local device manufacturer.

Strib device rep.png

With the story came the photo above, showing a device rep making his pitch to health care professionals. The story and the photo seem to come from a different planet - far away from any controversy or concerns about the coziness of such a reps-in-the-clinical-setting repertoire. Not a word about the kind of concerns that Dr. Carlat and so many others have raised. But as I've noted before, there appears to be an "anything goes" attitude with a different code of ethics for local business news on the business page.

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April 18, 2008

Tanning for dollars - researcher conflict of interest

The Wall Street Journal reports:

A Boston University researcher who authored an article in the New England Journal of Medicine last year recommending the moderate use of tanning beds as a way to treat or avoid vitamin-D deficiency has received research funding from an organization funded and controlled by the tanning-bed industry.

The link to researcher Michael Holick's work and the tanning industry wasn't made clear in the article. A note at the end of the article disclosed that Dr. Holick's research was funded, in part, by the UV Foundation. No information about the foundation was provided.

The nonprofit foundation, according to its Web site, is funded by the Indoor Tanning Association as well as the makers of tanning-bed equipment. The board of directors is composed entirely of tanning-bed-industry officials. Boston University was the top recipient of grants from the foundation from 2004 through 2006, the most recent three years of the group's Internal Revenue Service filings. In total, the university received $162,014 during that period.

On its Web site, the UV Foundation said it "has made a commitment of $150,000 over three years to Boston University, to continue the efforts of Dr. Michael Holick, a Vitamin D expert." The site said the foundation "is dedicated to exploring the positive effects of UV light and to increasing public awareness about those benefits."

Dr. Holick said in an interview that the money was an unrestricted grant that he used for vitamin-D research.

A report on the funding arrangement was to appear in Friday's edition of the Cancer Letter, a Washington-based trade publication. (See Cancer Letter story online.)


"I was surprised that the New England Journal, a very prestigious journal, would run the article this way," said Martin Weinstock, a Brown University dermatology professor. He said he was surprised the journal would run a piece by an industry-funded author.

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April 16, 2008

Ghostwriting: a scary practice

A case study in this week's Journal of the American Medical Association tells us more about the practice of ghostwriting.


Ghostwriting is the practice whereby academic researchers allow their names to be listed as publishers of research articles even though some, most or all of the writing may have been done by industry-hired medical writers. If there's any acknowledgement of the outside help at all, it's often euphemistically phrased "editorial assistance."

The JAMA case study is particularly interesting because it involves the case of research involving Vioxx (rofecoxib). The authors say their analysis "demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support."

Another JAMA article contends that Merck, makers of Vioxx, tried to minimize deaths in two studies showing that the drug didn't work in treating or preventing Alzheimer's disease.

Merck calls the reports false and misleading.

Ghostwriting is misleading and deceptive, and the practice should be dragged into the light of day more often for more to see what impact it may have on the integrity of science.

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April 8, 2008

Grassley Knocks Doc Taking Pharma Funds

The Wall Street Journal health blog reports:

"A University of Cincinnati psychiatrist who was the lead author of a 2002 study that concluded kids did well on AstraZeneca’s antipsychotic Seroquel has received hundreds of thousands of dollars from the company since then, according to Sen. Charles Grassley (R-Iowa).

Grassley raised the issue in a floor statement last week in support of a bill he’s co-sponsoring that would require drug and device makers with annual revenues of more than $100 million to disclose to the federal government on a quarterly basis anything of value given to physicians, such as payments, gifts, or travel expenses.

“Today, I am going to report on the actions of one physician to explain how industry payments to medical experts can affect medical practice,? Grassley said by way of introducing his remarks. Grassley then reviewed the funding for Melissa DelBello, who had reported to the University of Cincinnati that she had received $100,000 from AstraZeneca in 2003, the year after the study’s publication in the Journal of the American Academy of Child & Adolescent Psychiatry. She reported another $80,000 in 2004. The payments covered lectures, consulting fees, service on advisory boards and reimbursements for travel-related costs, Grassley said.

“The fact that a physician can promote a drug to other doctors and receive NIH funding, while hiding a very clear conflict of interest, is disturbing,? Grassley concluded."

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April 3, 2008

NEJM tries to clear up dirty lung study controversy

See the New England Journal of Medicine's correction, clarification and editorial over the controversial lung cancer CT screening study.

Posted by schwitz at 6:58 AM | Comments (0)
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How drug companies wine & dine doctors

An Australian newspaper gives a glimpse of how much drug companies spend to wine and dine doctors at "educational events." Excerpt:

"A drug giant spent more than $514,000 on a weekend seminar that included just six hours of "education content".

The symposium by Australian-based AstraZeneca included gourmet meals, alcohol and two nights free accommodation.

A new report shows "Big Pharma" is prepared to spend millions showering doctors with hospitality in the hope they will prescribe their drugs.

It reveals drug companies spent $31 million on educational events in the second half of last year, including $16 million on meals, airfares and accommodation.

Drug companies funded 14,643 functions during the period, 52 of which are under investigation for possible breaches of new industry rules.

Critics attacked the spending as an "orgy of wining and dining designed to schmooze doctors and boost the sales of new medicines".

But doctors claimed the hospitality amounted to little more than "a glass of orange juice and a sandwich".

Industry body Medicines Australia said drug companies had to keep doctors informed about new medicines.

"No one knows more about pharmaceuticals than the people who make them," chief executive Ian Chalmers said.

Medicines Australia refused to disclose which companies hosted the suspect events until the cases are reviewed.

Companies that breach the rules face $200,000 fines.

More than 220 gastroenterologists attended the AstraZeneca event, which was one of the most expensive disclosed.

Another company, Roche Products, spent $511,791 on a weekend hepatitis symposium for 337 specialists at Melbourne's Grand Hyatt, including $415,000 on hospitality.

Pfizer spent $340,000 on a cardiovascular forum for 220 specialists in Sydney, and Wyeth spent $333,000 sending 178 psychiatrists to an $1800-a-head event on Sydney.

Australian Medical Association president Rosanna Capolingua said the events were necessary and spending was reasonable."

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March 26, 2008

Tobacco conflict of interest behind lung cancer study

Gardiner Harris of the New York Times has just raised important new questions about the integrity of pro-screening work promoted by a leading researcher and published by the New England Journal of Medicine. Excerpt of his story:

In October 2006, Dr. Claudia Henschke of Weill Cornell Medical College jolted the cancer world with a study saying that 80 percent of lung cancer deaths could be prevented through widespread use of CT scans.

Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. A review of tax records by The New York Times shows that the foundation was underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands.

The foundation got four grants from the Vector Group, Liggett’s parent, from 2000 to 2003.

Dr. Jeffrey M. Drazen, editor in chief of the medical journal, said he was surprised. “In the seven years that I’ve been here, we have never knowingly published anything supported by? a cigarette maker, Dr. Drazen said.

Well, Dr. Drazen, knowingly or not, your journal did publish the work. Now what?

This should rock the world of medical science and medical journals.

Stay tuned. Kudos to reporter Harris for digging and shining light on this episode.

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March 18, 2008

Newspaper lets hospital buy news coverage

I've blogged in the past about TV news operations accepting sponsored news deals with local medical centers. In these deals, oftentimes the news only includes perspectives from that sponsoring hospital.

Now, in the first instance I'm aware of, the trend has come to newspapers. The HometownAnnapolis.com website of The Capital newspaper yesterday announced:

Partnership should improve health coverage

Published March 16, 2008

In today's editions we are experimenting with a new concept that could alarm some readers: Anne Arundel Medical Center, or AAMC, has paid us to provide content for our Health & Fitness page once a month.

Newspapers don't normally sell access to news pages, and certainly we would not give away content privileges on any other news page. I'm sure County Executive John Leopold would love to have his staff write the stories for the front page, but that's not going to happen for any price.

But partnering with the hospital on the Health page seemed to make sense. We don't have a health reporter to write about medical issues and often use stories from syndicated services that quote doctors from other cities.

The local hospital is giving us stories about local physicians and programs it has to offer - in their words, without an effort to balance the copy with comments from other hospitals or from doctors who don't practice at AAMC.

The stories are written in newspaper style and the hospital staff is responsible for the page's design. To be open and transparent about the partnership, a disclaimer is clearly displayed at the top of the page.

I'm not entirely comfortable with the arrangement, purely for journalistic reasons. But in the end I think the reader benefits - and that's my goal.

Instead of generic stories originating from another city, the reader will have local news featuring people they recognize, doctors they use and services that are available to them. The hospital staff is getting to the stories we are not able to write because of other priorities.

Is the page more readable now? You tell me.

Wow. "Partnering" - or being paid by a hospital to provide their news? Actually, he calls it content, not news. Whew. Because we used to call that advertising.

Also a relief - "the stories are written in newspaper style and the hospital staff is responsible for the page's design." So they'll look professional! Just like, or maybe even better than, real news.

And who cares if we give readers only one side of a story? Maybe a side that is so incomplete it can hurt them? And so what if we don't disclose the financial conflicts of interest of the doctors who might appear in the stories written and designed by the hospital itself? And so what if there are other opinions or other approaches from other doctors on the other side of town that don't get covered?

The main thing is: "Is the page more readable now?"

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March 17, 2008

Troubling questions about failure to disclose conflicts of interest

The Cancer Letter (subscription required), a terrific publication about federal cancer policy and funding, opens new questions about disclosure of conflicts of interest in this country.

The Integrity in Science Watch project summarized it this way:

In the wake of allegations that a prominent lung cancer researcher failed to disclose a patent licensed to General Electric on interpreting CT scans in an article that claimed early CT scanning could substantially reduce lung cancer mortality, the New England Journal of Medicine last month ruled the patents “not relevant? to the subject of the article and refused to print a correction. Now, a follow-up investigation by the Cancer Letter, an industry newsletter, uncovered numerous instances when Weill Medical College researcher Claudia Henschke failed to disclose the patents in a series of continuing medical education (CME) seminars, including one held by the Radiological Society of North America (RSNA) a month after the article appeared in October 2006. The NEJM article could also be read for CME credit.

The Accreditation Council for Continuing Medical Education in 2005 adopted strict rules for disclosing granted and pending patents held by any presenter at a CME activity. “Royalties by themselves establish the financial relationship of the person with a commercial interest and create the potential for conflict of interest. Therefore, the relationship is relevant in CME,? Murray Kopelow, the chief executive of ACCME, told the Cancer Letter. The Center for Science in the Public Interest later this week will ask the ACCME to order all the CME providers where Henschke failed to disclose to send proper disclosures to anyone who participated in those activities. And Sen. Charles Grassley (R-IA) said he plans to launch a Congressional inquiry in physician patenting activity. “It’s becoming clear that patents and royal payments to doctors deserve a lot more scrutiny from Congress, the FDA, professional journals and other watchdogs,? Grassley said.

This one is complex - involving researchers' disclosure, medical journals' policies, and the whole big, murky mess of continuing medical education.

And it's important - for the sake of honest, transparent, open disclosure of questions at the very heart of the integrity of scientific medical research.

Kudos to the bulldogs at the Cancer letter, who say that although their publication is subscription only, they'll send this particular article to any interested party if you e-mail them at: kirsten@cancerletter.com or paul@cancerletter.com.

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March 15, 2008

Medicare to pick up tab for more heart scans

Earlier this week, Merrill Goozner may have given us the spot-on scary political reality when he put his touch on the story of Medicare approving new payments for expensive heart scans. Excerpt:

I suspect there will be a lot more of these decisions over the next nine months as Bush administration appointees hoping to line up their next jobs grant top-of-the-wish-list favors to special interests.

The New York Times website reported Wednesday that the Center for Medicare and Medicaid Services has reversed a proposed policy to cut off paying for heart scans, which can cost $600 or more. The preliminary decision announced last December found no clinical evidence that heart scans identify heart disease any better than other non-invasive procedures, like a stress test. According to the paper:

Medicare’s initial proposal, which would have ended payment for the scans unless the patients were enrolled in studies to determine the technology’s effectiveness, had met with fierce resistance from the doctors who perform these scans and the companies that make the equipment. They strongly defended the use of these scans as an important alternative to traditional angiography. ...

Lobbying by docs and equipment makers. Pay first, evidence later. It's the American way.

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March 13, 2008

Sleep may be not be the big problem special interests claim it is

I've blogged about the cloud of doubt that should hang over the annual proclamations made by the National Sleep Foundation during the highly-promoted National Sleep Awareness Week. The reason: special interests like sleeping pill makers fund the effort.

Now the Washington Post reports:

Americans are not as sleep-deprived as they think they are and, in fact, appear to be getting more Z's these days than they got a few years ago, according to an independent analysis of government statistics.

The new findings run counter to the widespread public perception that Americans are getting less and less sleep because of increasing workplace demands and the plethora of distractions available around the clock on the Internet and cable television.

"Many Americans work too much, but most do not seem to be cutting corners on their sleep to do so," said John P. Robinson, a sociologist at the University of Maryland, who led the analysis with faculty colleague Steven Martin.

Their report, "Not So Deprived: Sleep in America, 1965-2005," scheduled for release by the university today, finds that Americans on average got 59 hours of sleep per week in 2005, the latest year for which precise statistics are available. That is three hours more than in 2000.

The new numbers contrast significantly with the 2008 "Sleep in America" poll, the oft-quoted survey conducted annually by the Washington-based National Sleep Foundation, which advocates for better diagnosis and treatment of sleep problems.

Released last week, that survey concluded that Americans get an average of 48 hours of sleep per week.

The difference, experts said, reflects the two groups' methodologies. The Sleep Foundation survey asks Americans to estimate how much sleep they typically get. By contrast, the Maryland analysis draws upon detailed "time-use" data collected by the U.S. Census Bureau for the Department of Labor Statistics. In that approach, individuals must account for every minute of the previous day.

"This gives us a much better picture of where the time goes than when people just make an estimate," Robinson said.

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March 4, 2008

Here we go again - another industry-funded Sleep Awareness Week

Don't let the special interest campaign catch you napping!

Dozens upon dozens of stories about Americans lacking sleep are popping up from news organizations all over the country this week, driven by another of the National Sleep Awareness Week campaigns of the National Sleep Foundation.

Few - if any - of these stories will tell you that it is industry special interests - sleeping pill makers, sleep labs, mattress makers - who are paying for this campaign. They do it every year. And news organizations fall into line like sheep and report the "new" findings every year.


USA Today reports:

U.S. workers are silently suffering from a dramatic lack of sleep, costing companies billions of dollars in lost productivity, says a study out Monday.

Nearly three in 10 workers have become very sleepy, or even fallen asleep, at work in the past month, according to a first-ever study on sleep and the workplace by the non-profit National Sleep Foundation. The late-2007 survey was based on a random sample of 1,000 workers.

AP reports:

Hey you! Dozing at your desk! Wake up, go home and get more sleep! That could be the message from a survey released Monday by the National Sleep Foundation. The survey of 1,000 people found participants average six hours and 40 minutes of sleep a night on weeknights, even though they estimated they'd need roughly another 40 minutes of sleep to be at their best.

CNN, WebMD, UPI, the St. Louis Post-Dispatch and many, many more news organizations are reporting the same stuff - handed to them by the industry-funded campaign.


Wake me when the next disease-mongering campaign comes around.

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March 3, 2008

What is there to debate about medicine's conflicts of interest?

As proof that you can foster debate over just about anything, the BMJ hosts a journal debate over the question of "Has the hunt for conflicts of interest gone too far?"

Harvard professor Thomas Stossel says "Yes," arguing that restrictions on doctors’ and academics’ interaction with commercial companies are damaging research.

But UCSF professor Kirby Lee says "No," believing that scrutiny of potential conflicts of interest is a price worth paying to maintain public trust.

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February 28, 2008

Industry influence on medicine

Australian journalist Ray Moynihan writes in the BMJ about “the invisible influence of drug company sponsorhip? of doctors’ educational seminars. He writes that:

“it is not uncommon for drug company sponsors to suggest speakers at sessions that are assumed by the thousands of general practitioners who attend them to be totally independent. Drug industry representatives have confirmed that similar practices take place in the United Kingdom, where roughly half of all education for doctors is sponsored by drug companies.

In the case of one popular Australian provider of medical education, HealthEd, leaked documents and emails from a range of sources show drug company sponsors having input into the selection of some speakers at seminars held in recent years, despite the fact that these have been aggressively sold to general practitioners in brochures claiming that "all content is independent of industry influence."

Meantime, today's Star Tribune reports on a U.S. Senate hearing called "Surgeons For Sale." Excerpt:

Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to "adult entertainment" clubs. Fat checks for what some see as questionable work.

Such payments to doctors by medical device companies -- often disguised as "consulting agreements" meant to encourage use of their products -- were the subject of a packed, daylong hearing Wednesday before the U.S. Senate Special Committee on Aging.

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February 27, 2008

Drug Trials Should Not Be Done for Marketing Purposes Only

I've blogged earlier about something being smelly about the ENHANCE trial, comparing the cholesterol drug Zetia plus Zocor versus Zocor alone.

This week, a commentary in the Journal of the American Medical Association addresses some of the stink. Excerpts:

The unusual release on January 14, 2008, in the news media and on a drug company Web site, of a portion of the Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE) trial data resulted in numerous articles and commentaries in the lay media. The availability of only fragmentary information created massive confusion and raised many more questions than answers for patients, physicians, pharmaceutical companies, and regulators. A full report of the ENHANCE trial in a peer-reviewed medical journal is not expected for months, and the first public presentation of the study's findings in a medical setting will not occur before late March 2008.

Lesson 1: Drug Trials Should Not Be Done for Marketing Purposes Only

Lesson 2: The News Media Must Be Sure to Get the Facts Straight. Errors in Reporting Can Cause Serious Damage, and Patients May Be Harmed or Become Distressed From the Resulting Confusion

Lesson 3: Leading Scientific, Patient-Oriented, and Disease-Oriented Organizations Must Scrupulously Avoid Conflict of Interest

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January 31, 2008

Financial conflicts of interest in spine study

The New York Times reports on the testing and approval of an artificial spinal disc - the Prodisc. The Times says the case "provides a stark example of conflicts of interest among clinical researchers — conflicts that are seldom evident to doctors and patients trying to weigh the value of a new device or drug. Instead of serving as objective gatekeepers who can screen out potentially harmful or ineffective new devices or drugs, clinical researchers with conflicts may have incentives to overstate the value of a new product for patients."

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January 9, 2008

Who's Behind the Bible of Mental Illness?

I'm late in drawing attention to an article from several weeks ago in U.S. News & World Report.
It was headlined, "Who's Behind the Bible of Mental Illness: Critics say that touted efforts against conflicts fall short." Excerpt:

In what is arguably the most important mental-health development since the early 1990s, the American Psychiatric Association will spend the next five years producing a new edition of the psychiatrist's "bible," the official guidebook for diagnosing mental problems. The Diagnostic and Statistical Manual of Mental Disorders, as it is known, is hugely influential because it determines what is and is not a mental disorder. In turn, it is responsible for much of the sales growth in prescription drugs.

The most recent edition of the DSM, published in 1994, drew controversy because it turned what had once been a thin guidebook into an 886-page tome that significantly expanded the definition of mental illness. Traits once associated with shyness, for example, became symptoms of "social anxiety disorder." And drug companies went on to spend millions promoting medicines for those problems. Eyebrows were further raised in 2006 when a study showed that more than half of the researchers who worked on the manual had at least one financial tie to the drug industry.

This time around, pledging to avoid even the appearance of conflicts, the APA has instituted screening procedures for the 27 members of its DSM task force, asking them for detailed financial information about stocks, honoraria, and consulting fees from drug interests. It calls the effort the "most transparent" in the medical industry. Yet the summaries of the disclosure statements that were recently released to the public are remarkably spare; they show only the existence of corporate connections, not their dollar amount or their duration. The result is a document that even an APA board member suggested is not very revealing. In a 2006 memo to the board obtained by U.S. News, William Carpenter wrote: "Simple listing of all relationships is not very informative and does not identify potential conflicts that may need to be resolved."

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December 17, 2007

Conflict of interest in continuing medical education

John Mack, publisher of Pharma Marketing News, recently wrote an essay worrying about drug industry support of continuing medical education or CME. Excerpts:

"In 2006, commercial support of CME totaled about $1.19 billion ($1.44 billion if you include advertising and exhibits at CME events). That represents about 50% of the total support.

Why won’t physicians pay for CME?

Although $1.2 billion is only a small fraction of the total promotional spend of the industry, a billion here, a billion there, and pretty soon we’re talking about real money! Why should pharma contribute so much for CME in the first place? Doesn’t that naturally lead to biased content? Shouldn’t there be a ban on commercially-funded accredited CME? Why can’t physicians pay for their CME like many other professionals do?"

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December 7, 2007

Reminders of how much money people make in medicine

Item 1 in today's news:

Former UnitedHealth CEO Bill McGuire finally settled with the Securities and Exchange Commission over his stock options scandal. In all, he pays back $618 million. But don't lose sight of the fact he still holds options that are valued at $1.8 billion.

Item 2 in today's news:

A former department head fired from the Cleveland Clinic claims there are pervasive conflicts of interest at the world-renowned hospital. The Wall Street Journal reports the former head of the clnic's vascular intervention unit (a big bucks operation),

"said a number of the hospital's top doctors promote devices and treatments that they have a financial interest in, sometimes without informing patients. ... His suit alleges the clinic has been "indifferent" to financial conflicts of interest and that such situations are "widespread and pervasive." Those conflicts start at the top with clinic chief executive Delos "Toby" Cosgrove, according to the complaint. The lawsuit says the clinic heavily promotes and uses an invention of Dr. Cosgrove's in patients undergoing heart-valve surgery. Dr. Cosgrove and the clinic both receive royalties from sales of the product, known as the Cosgrove-Edwards ring and marketed by Edwards Lifesciences Corp. The lawsuit says patients aren't given the choice of using competing rings or told that the hospital and its chief executive profit from sales of the Cosgrove-Edwards ring."

Some have called the issues of conflict of interest in patient care "a ticking time bomb" in health care.

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December 5, 2007

You can find experts without conflicts of interest

The FDA has been criticized for how many scientists with conflicts of interest that the agency allows to serve on its advisory committees. The FDA says it can't find conflict-free experts. But a study by the Integrity in Science Watch project of the Center for Science in the Public Interest (CSPI) suggests the FDA isn't looking hard enough.

CSPI reports:

"For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not. ... Choosing well-qualified advisers without conflicts of interest instead of conflicted experts will strengthen the nation's food and drug safety system."

CSPI, along with other prominent science and consumer groups, urged the FDA "to adopt the conflict-of-interest guidelines the agency published last March. Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."


Meantime, read Maggie Mahar's blog for details on the FDA Science Board report, "FDA: Science and Mission At Risk." Some lowlights:

* “The Information Technology situation is problematic at best—and at worst it is dangerous.?
* “The FDA has substantial recruitment and retention issues?.
* “Critical data…including valuable clinical trial data...are sequestered in piles and piles of paper documents in large warehouses."
* “The FDA has an inadequate and ineffective program for scientist performance."
* "The FDA has inadequate funding for professional development to ensure that staff maintain scientific competence."

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November 9, 2007

Drug company gifts to Third World doctors

The UK newspaper, The Independent, reports:

"Multinational drug companies are showering doctors in the developing world with gifts and inducements to persuade them to prescribe drugs of dubious value, an investigation has revealed.

Intense marketing of medicines has resulted in up to half of drugs being wrongly prescribed, the campaign group Consumers International says in its report Drugs, Doctors and Dinners. It calls for a ban on gifts to doctors.

A GP in Malaysia, Rafik Ibrahim, who practises near the capital, Kuala Lumpur, described how in a period of five weeks in August last year he spent 17 hours with drug-sales representatives who approached him on behalf of 25 drug companies. In Pakistan, doctors who wrote 200 prescriptions for one high-price drug were offered the down payment on a new car.

Multinational companies are turning to the developing world as profits stagnate in the West. But regulation in these countries is weak and drug sales representatives can influence prescribing by the inducements they offer.

India was one of the fastest-growing markets last year, with sales increasing 17.5 per cent to $7.3bn. But the health commission, in 2005, labelled 10 out of the 25 top-selling medicines as being "irrational or non-essential or hazardous".

Richard Lloyd, of Consumers International, said: "The pharma industry sees the developing world as a trillion-dollar opportunity... but consumer health expenditure in these countries can ill afford to be squandered." He added: "The best way to ensure patients in the developing world get rational impartial treatment is... to ban gifts for doctors." "

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October 17, 2007

Influence of industry on academic medicine

A new study published in the Journal of the American Medical Association gives perhaps the best picture yet of how extensive are industry-academic relationships are in medicine. The authors surveyed department chairs in the 125 accredited allopathic medical schools and the 15 largest independent teaching hospitals in the United States. 67 percent of the 688 eligible department chairs completed the survey.

It showed that "almost two-thirds (60%) of department chairs had some form of personal relationship with industry, including serving as a consultant (27%), a member of a scientific advisory board (27%), a paid speaker (14%), an officer (7%), a founder (9%), or a member of the board of directors (11%). ... More than two-thirds of chairs perceived that having a relationship with industry had no effect on their professional activities, 72% viewed a chair's engaging in more than 1 industry-related activity (substantial role in a start-up company, consulting, or serving on a company's board) as having a negative impact on a department's ability to conduct independent unbiased research."

The authors concluded:

"Failure to address the existence and influence of industry relationships with academic institutions could endanger the trust of the public in US medical schools and teaching hospitals."

The Associated Press reports:

Dr. Jerome Kassirer, a former New England Journal of Medicine editor and frequent critic of industry influence over doctors, called the study eye-opening.

"I was appalled by the results," Kassirer said. "No one knew that so many chairs of medicine and psychiatry were paid speakers. We've never had that data before."

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September 7, 2007

British M.D.-journalist slams journalists for conflicts of interest

Ben Goldacre, in this week's BMJ writes:

I was surprised last week by an email circular I received from a science writers' mailing list. It was from the Aspirin Foundation, a group funded by the drug industry, and it was offering—on behalf of Bayer Healthcare—to pay expenses for journalists to attend the European Society of Cardiology's conference in Vienna.

Now aspirin is without doubt an excellent and cheap drug. But in my naivety I had no idea such things went on. I pinged off a few emails to friends and colleagues. Most poked fun at my innocence—quite rightly—but some were helpful. Not only is it extremely common for journalists to take money from drug companies, but there have been some astonishing cases in recent history, including one memorable case where a PR company invited journalists to "an exclusive preview" of new laser eye technology, with the offer to "discuss free treatment in return for editorial features."

"I organise the media programmes for a number of medical conferences run by scientific societies," said one person who, without wishing to be melodramatic, has asked to remain anonymous, "and I reckon at least 50% of the journalists present are paid for by drug companies. They get pretty well looked after too—first class travel, five star hotels, posh dinners, etc. Some of them indulge in double dipping, where they are paid by the day by the drug company and then by the publication that takes whatever they have written. Sometimes they don't even use the press room, spend all their time in company hospitality suites, and just go to company sponsored satellite sessions and press conferences."

Perhaps I'm naive, but I don't buy Ben's claim that it's "extremely common for journalists to take money from drug companies." But the points he makes about pharma's pervasive and troublesome influence on some journalists and news organizations is worth noting. He wrote:

"...There are real dangers in being too close to PR people: lovely though they may be, their trade is, by definition, manipulation. Drug companies are businesses, with responsibilities to their shareholders, and they wouldn't pay for journalists to attend their events if they didn't think it would affect media coverage of their product. After all, a journalist's article is far more credible than a paid advertisement, for anybody's money, and more likely to be read by potential consumers. ...

It's much easier to get someone to take your calls when they've taken your money. And I, for one, will in future read outraged media reports of academic conflicts of interest with a wry smile indeed."

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June 11, 2007

Journal Watch tracks conflict of interest

It may become easier to discover journal article authors' potential conflicts of interest, through the web site, Journal Watch.

The Wall Street Journal reports the system adopted by Journal Watch "was the latest move to toughen disclosure after a series of cases in which authors' ties to the pharmaceuticals industry weren't disclosed. Journal Watch is owned by the Massachusetts Medical Society, publisher of the New England Journal of Medicine. Under Journal Watch's new system, to be adopted later this month, online readers will be able to click on an author's name and instantly see disclosures about his or her financial ties to drug makers and other sources of support. The site, aimed at doctors, summarizes significant articles on recent medical journals."

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May 30, 2007

Pharma-funded nurses in UK - backdoor drug marketing?

The Wall Street Journal reports on a new drug company scheme in the UK.

Under the guise of "disease management programs," the paper says that drug companies are paying for nurses in doctors' offices to study patient charts to find people with chronic illnesses - which may often lead to a new prescription of a drug made by the company funding the nurses.

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May 29, 2007

Drug Industry Gifts Make Gastro-Conference Easier to Digest

From Caroline Rodriguez at the Integrity in Science Watch project of the Center for Science in the Public Interest:

"More than 15,000 doctors visited Washington, D.C. last week to attend the largest ever gathering of gastrointestinal physicians. Integrity in Science Watch paid a visit.

As soon as each doctor walked onto the convention floor, they were handed purple-pill backpacks advertising Nexium from AstraZeneca. The Shire Pharmaceuticals’ booth offered weary physicians a park-like atmosphere complete with gently rolling grassy hills, stone paths, park benches, and free hot dogs. The Abbott booth contained a mini-movie theater. On every aisle, companies provided free slushies, gourmet espressos, coffee, tea, sweets, hot dogs, and fresh pretzels. They also offered beach towels, blankets, movies, free internet access, and, the most popular gift of all, a comfortable place to sit and chat with colleagues or the model-like sales representatives who prowled the convention floor.

Most of the doctors surveyed did not express concerns about the potential influence of the gifts. Some said they expect free knick-knacks at conferences, but would oppose them at schools or hospitals. Others said it was important for companies to promote themselves. Almost no one favored cutting out free gifts at physician conventions and offices, but perhaps that was because this informal survey only included doctors clutching blankets, towels, key chains, or pens.

The quietest space on the convention floor was the corner reserved for the small booths of patient advocacy groups, text book sellers, and scientific journals. “We don’t get any sponsorship from corporations for our meeting booths,? said Crohn’s & Colitis Foundation of America representative Laura Hitchens, eyeing the towering Fuji stereo sound system blaring a description of a colonoscopy camera. Thelma King Thiel of the Hepatitis Foundation says they wouldn’t say no if a company was to offer to fund their booths, but not many companies are interested in prevention, she said."

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April 30, 2007

Drug company influence on patient advocacy groups

Here is more evidence of drug company influence on patient advocacy groups.

The need for disclosure is so clear - so that sick people are not misled into thinking that all of the information they get from some advocacy groups is unbiased and free from outside influence.

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April 17, 2007

Conflict of interest in advanced diagnostic imaging

The Health Affairs website today published a study that shows how physicians are often stretching or breaking the law when they refer patients to diagnostic imaging facilities with which they have a financial relationship. Excerpts:

"Laws enacted during the early 1990s to curb physician self-referral were a major step toward addressing the concerns about these arrangements; however, they contain exceptions that could enable self-referral to reappear but in a different form tailored to fit the exemption. This study is the first to document the prevalence and scope of self-referral arrangements in light of these exceptions. ...

Using data from a large insurer in California, we identified the self-referral status of providers who billed for advanced imaging in 2004. Nearly 33 percent of providers who submitted bills for magnetic resonance imaging (MRI) scans, 22 percent of those who submitted bills for computed tomography (CT) scans, and 17 percent of those who submitted bills for positron-emission tomography (PET) scans were classified as "self-referral." Among them, 61 percent of those who billed for MRI and 64 percent of those who billed for CT did not own the imaging equipment. Rather, they were involved in lease or payment-per-scan referral arrangements that might violate federal and state laws. ...

These findings should be of considerable concern to policymakers, employers, insurers, and consumers who recognize the need to control rapidly escalating health care spending. Efforts that address the exemptions in existing federal and state prohibitions on physician self-referral are likely to have major impacts on the increased use that characterizes these arrangements."

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April 7, 2007

60 Minutes on pharma influencing Congress - but why so late?

If you didn’t see 60 Minutes last Sunday (April 1), go to their website and read the story and watch the video link for the segment called “Under the Influence.? It’s the story of the incredible manipulation of Congress by the drug industry that took place to get the Medicare Part D legislation passed.


The unorthodox roll call on one of the most expensive bills ever placed before the House of Representatives began in the middle of the night, long after most people in Washington had switched off C-SPAN and gone to sleep.

The only witnesses were congressional staffers, hundreds of lobbyists, and U.S. Representatives like Dan Burton, R-Ind., and Walter Jones, R-N.C.

"The pharmaceutical lobbyists wrote the bill," says Jones. "The bill was over 1,000 pages. And it got to the members of the House that morning, and we voted for it at about 3 a.m. in the morning."

Why did the vote finally take place at 3 a.m.?

"Well, I think a lot of the shenanigans that were going on that night, they didn't want on national television in primetime," according to Burton.

"I've been in politics for 22 years," says Jones, "and it was the ugliest night I have ever seen in 22 years."

Despite what a terrific piece this was, one wonders why it took 60 Minutes several years to catch up to this story. Some viewers wrote to CBS about how late this report came. Examples:

“Great story, AWESOME Story!!! Too bad CBS & 60 minutes waited over 3 YEARS after President Bush Jr. signed the bill into law to report on this. Perhaps if we the American people had heard this story back in early 2004, we would have made different choices when the 2004 presidential election came around.?

“CBS, where the hell were you in reporting this when it happened. Everyone else who was paying attention knew we were being screwed by this legislation, that it was just a give away to the drug companies. but like all (mainstream media), you were totally going to let it pass. Shame on you for taking so long wake up.?

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April 5, 2007

FDA Okays Conflicts on Committee Considering Merck’s New Pain Pill

The Center for Science in the Public Interest reports:

The Food and Drug Administration last week gave three scientists, including two with financial ties to Merck, permission to serve on an advisory committee and to vote on the fate of the company’s new Cox-2 inhibitor pain pill. The Arthritis Drugs Advisory Committee will consider Arcoxia (etoricoxib) when it meets later this month. Preliminary clinical trial data released by the company last year indicated Arcoxia raises blood pressure in some patients, but does not result in the same heart attack risk as Vioxx, the Cox-2 inhibitor Merck removed from the market in late 2004.

According to agency documents that were released last week, the committee will include Robert Levine, a gastroenterologist at the State University of New York, who owns between $25,000 and $50,000 in Merck stock. The FDA identified four gastroenterologists willing to take the slot, but two had more extensive conflicts than Levine. The FDA also granted a waiver to Kenneth Saag, a rheumatologist at the University of Alabama at Birmingham, who receives somewhere between $10,000 and $50,000 a year from Merck. Saag, the FDA said, is expert in analyzing large databases (Merck has tested the drug in over 35,000 patients) and the agency “was unable to find anyone as qualified.? However, the agency admitted that it only scrutinized its current roster of advisers and employees of the National Institutes of Health to identify candidates. Committee chair Dennis Turk, an anesthesiology professor at the University of Washington, also received a waiver for the $10,000 a year or less he earns from a company that competes with Merck on unrelated issues.

The Wall Street Journal reports:

Merck tested Arcoxia in a massive study, called Medal, that included 34,701 patients enrolled in three trials. The study showed a similar cardiovascular risk for Arcoxia and an older drug, diclofenac. But FDA committee members may question the use of diclofenac as the comparator, because while diclofenac is not categorized as a Cox-2 drug, experts including the American Heart Association view it as closer to the Cox-2s than other painkillers in its class. "What they did is say, our Cox-2 is similar to another Cox-2," says Bruce Psaty, a professor at the University of Washington who wrote about the issue in a recent New England Journal of Medicine commentary. "That's not terribly reassuring."

Steven Nissen, immediate past president of the American College of Cardiology, also pointed out that more patients on certain Arcoxia doses dropped out of the study due to high blood pressure. "I do not believe that [Arcoxia] should be approved," he said.

Wanna bet on the outcome?

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March 23, 2007

Concern over doctors' ties to drug companies

The Star Tribune today has more details from the reports filed with the Minnesota Pharmacy Board about drug company payments to physicians. Minnesota and Vermont are the only two states that require drug companies to publicly disclose such payments.

The paper's lede:

Dr. Inder Anand went to Paris. Dr. David Lowe went to Mankato. And Dr. Rex Haberman traveled across the United States.

The three Minnesota doctors took the trips at the expense of pharmaceutical companies, which paid them tens of thousands of dollars in 2005 for their expertise and time.

The paper also reported:

Meanwhile, the reporting system that tracks payments in Minnesota was criticized in this week's journal article as flawed and incomplete.

State officials confirmed that one drug maker, Pfizer, did not file a 2005 report with the pharmacy board, even though it reported $2.8 million in payments in 2004.

"I'll be sending them a letter," said Cody Wiberg, the board's executive director. A Pfizer attorney did not return a call for comment Thursday.

Because of the increased public interest in the filings, Wiberg said the board will post copies of the documents on the board's website.

Eventually, he wants to put all of the information in a database so the public can search by doctors' names.

The paper lists some of the big givers and some of the big receivers.

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March 22, 2007

Lots of drug-related conflict of interest news this week

Gardiner Harris of the New York Times is all over issues about drug company influence on doctors and on the FDA this week. Today he writes:

Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.

Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.

A “significant number? of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many.

Yesterday, Harris' story on "Doctors' Ties to Drug Makers Are Put on Close View" simply blew away the competition - better by far than any other story I saw on the subject in many media across the country - including right here in Minneapolis. He and Janet Robert reported on records in Minnesota, where drug makers are required to disclose payments to doctors.

The Minnesota records are a window on the widespread financial ties between pharmaceutical companies and the doctors who prescribe and recommend their products. Patient advocacy groups and many doctors themselves have long complained that drug companies exert undue influence on doctors, but the extent of such payments has been hard to quantify.

The Minnesota records begin in 1997. From then through 2005, drug makers paid more than 5,500 doctors, nurses and other health care workers in the state at least $57 million. Another $40 million went to clinics, research centers and other organizations. More than 20 percent of the state’s licensed physicians received money. The median payment per consultant was $1,000; more than 100 people received more than $100,000.

The reporting on this latter story was complete and comprehensive, with many examples of Minnesota physicians receiving surprising amounts of money from drug companies; ten doctors and one dentist received more than $500,000. You should read the entire story. But be ready to take an anti-anxiety pill when you're done.

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March 8, 2007

Conflict of interest controversy with med school dean

The St. Paul Pioneer Press reports on a controversy surrounding University of Minnesota Medical School Dean Dr. Deborah Powell joining the board of PepsiAmericas, one of the world's largest sellers of Pepsi and Mountain Dew.

The paper reports:

“A recently completed internal review, standard for any U employee involved in outside work, found no conflict of interest in her service to PepsiAmericas, a publicly traded company that is the world's second-largest bottler of PepsiCo. brands.

That may not put the matter to rest. The appointment has wound itself into the national debate over how food and soft-drink makers do business. The basic questions: Can a doctor take money from a corporation but stay independent? Is joining a corporate board equal to endorsing its products?

‘If I didn't think I could make a difference on this board, I wouldn't stay on it, and I wouldn't go on it in the first place,’ Powell said Friday. ‘I'm trying the best I can to do something that I think will be valuable for the school and valuable for this company.

‘If it turns out it doesn't create value, then I won't stay on this board,’ she said.

Inside the U's health programs and departments, divisions remain over Powell's decision. Some have expressed hope that she can be a voice for children's health.

But Robert Jeffery, a nationally known researcher and a director of the Obesity Prevention Center in the U's school of public health, worries Powell's PepsiAmericas duty ultimately may hurt the university.

‘There is a level of 'ick' among quite a few faculty and students here,’ Jeffery said. ‘There definitely are some sour feelings. When you're talking about some of the most powerful people in the university backing it, it makes it distasteful.’

The U, he said, needs to have a ‘more serious conversation about where the ethical lines lie in corporate consulting. Whenever you get into a paid relationship with a commercial enterprise, there is an implied or maybe even explicit agreement that you're doing things for their benefit. I certainly would not have agreed to this.’ “

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February 27, 2007

In search of conflict-free experts

The Integrity in Science Project of the Center for Science in the Public Interest reports:

"The Food and Drug Administration's latest report on the make-up of its advisory panels reveals that little has changed in the 15 months since Congress required the agency to document its efforts to find scientists without ties to industry. In a report sent to Capitol Hill on Jan. 31, FDA Commissioner Andrew von Eschenbach reported that 24 percent of advisers to the agency’s seven centers and offices received conflict-of-interest waivers between November 2005 and January 2007. The Center for Drug Evaluation and Research (CDER) had the worst performance, with 146 of 417 advisers, or 35 percent, requiring waivers because they owned stock in, consulted for, or served on the speakers' bureaus of firms with products up for approval or their competitors.

The agency's ability to identify advisers without conflicts of interest has not budged since Congress acted. ...
When questioned about the agency's failure to reduce its reliance on outside advisers with ties to industry, acting deputy commissioner Randall Lutter said that 'it is very difficult to get the quality of the expertise we want without going to people who have some sort of relationship with industry related to product development.' But as a Lancet editorial noted in 2005 shortly before Congress passed its law, 'it is hard to believe that in a country with 125 medical schools – not to mention the pool of international experts – the FDA cannot find experts who do not have financial ties with companies whose products are under review.' A New York Times editorial has pointed out that 'unless the FDA makes a more aggressive effort to find unbiased experts or medical researchers start severing their ties with industry, a whiff of bias may taint the verdicts of many advisory panels.' "

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February 20, 2007

PBS ombudsman thinks Glaxo sponsorship isn't worth it

Broadcasting & Cable magazine reports:

"The sponsorship of a PBS program on obesity by diet drug maker GlaxoSmithKline has one veteran noncom TV watcher a bit exercised, but PBS says it is by the book.

Jeff Chester, executive director of the Center for Digital Democracy, and a frequent critic of what he sees as the increasingly commercialization of noncommercial broadcasting, has written to PBS ombudsman Michael Getler to complain about what he sees as too lax sponsorship policies.

Glaxo is underwriting the April broadcast of 'Fat: What No One is Telling You' ...

'We note that funding comes in part from GlaxoSmithKline,' Chester wrote Getler. 'The drug giant just happens to have a recently approved for over-the-counter drug on the market-under the brand name Alli, that is for 'use by overweight adults along with a reduced calorie, low-fat diet.' ...

PBS program executives need to 'cut the fat' out of their sloppy review of what's appropriate for underwriting,' said Chester."

Getler responded on his PBS ombudsman blog: "My view is that Chester’s eagle-eye provides a continuing, very useful challenge to PBS, a challenge that I agree with even though I sympathize with PBS’s constant search for funding, the difficulty of finding sponsorships to bolster more traditional funding, and that fact that some funders simply have an interest in seeing subjects aired and are willing to take their chances on how the program will come out. But in this case, there is little doubt how a program about obesity is going to turn out. Even though GlaxoSmithKline came in late and, under PBS policy, has no say in any of the content, this kind of possible conflict can undermine credibility and, without knowing the financial details, doesn’t seem worth it. "

(GS note: Thanks to one of my blog readers for tipping me off to this controversy.)

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February 6, 2007

Canadian paper bites on pharma-funded advocacy

A Vancouver Sun story is a good example of an imbalanced story that fails to address health policy issues with context and completeness. The story reports on an advocacy group report and, in so doing, takes a flawed advocacy stance itself.

The story begins: "Cancer patients are increasingly having to pay for important new drugs administered in public hospitals, the latest symptom of Canada's inconsistent and often inadequate funding of cancer treatment, an advocacy group reported Monday."

The story says, "One breakthrough leukemia drug is paid for by just a single province, (British Columbia)." The story didn't explain what qualifies as a breakthrough.

Then the story dipped into the language that is usually used when cost-effectiveness decisions are made by government officials - "rationing." The story says, " 'Essentially, we will continue to ration life-saving cancer treatment, and some Canadians will live and some will die simply because of where they live,' said the report."

Late in the story, it finally disclosed that the advocacy group was financed largely by pharmaceutical companies.

The report also looked at the availability of PET (positron emission tomography) scans and mammograms for cancer patients, raising questions about what the report said was underuse of the two technologies.

But overuse of PET and other scanning technologies is generally a bigger concern than underuse. And who's to say that women aren't choosing to forego mammography after weighing the evidence? The story certainly didn't look into that possibility.

Journalists will not contribute to a meaningful discussion on health care reform if they take the party line of a pharma-funded advocacy group as gospel.

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February 3, 2007

Molly Ivins would have loved this one

Molly Ivins used to call Texas governor Rick Perry, "Governor Good Hair," or Governor Rick "Good Hair" Perry.

But Molly would have had a field day with this news: Texas on Friday became the first state to require school-age girls to be vaccinated against a sexually transmitted virus that has been shown to cause cervical cancer.

The LA Times reports that Perry "signed an executive order mandating that most girls, starting in September 2008, receive the vaccination against the human papillomavirus before entering sixth grade. ... By sidestepping the Texas Legislature, Perry — a conservative Republican — avoided a showdown with GOP lawmakers and Christian organizations that oppose mandatory HPV vaccinations."

In so doing, Governor Good Hair was praised by some liberals and public health advocates. But, the Times reports, "the move drew criticism from conservative groups, which noted that the governor had accepted campaign contributions from the vaccine's manufacturer, Merck & Co.

'All Merck wanted was a mandate so the insurance companies would have to pay for this. Follow the money,' said Cathie Adams, president of the Texas Eagle Forum, an organization that promotes socially conservative government policies. ...

Merck has been pushing for laws mandating its Gardasil vaccine in numerous states. It has also launched a TV ad campaign featuring girls and the slogan 'One less,' to signify one fewer cancer patient for each person vaccinated.

The New Jersey-based drug company donated $6,000 to Perry's reelection campaign last year, Texas campaign finance records show. One of its top Texas lobbyists, Mike Toomey, is Perry's former chief of staff."

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January 31, 2007

Kidney Foundation conflicts of interest?

The Integrity in Science Project of the Center for Science in the Public Interest reports:

"The non-profit National Kidney Foundation is refusing to release the final roster of the expert panel that meets in Dallas on Saturday to re-evaluate its anemia guidelines for people suffering from chronic kidney disease. Recent studies show that raising red blood cell counts to meet targets established in the 2006 NKF guidelines increases strokes and heart attacks for people on dialysis, and hastens the onset of dialysis for people with chronic kidney disease. Eleven of the 16 members of the committee behind those guidelines, which were underwritten by Amgen Inc., had ties to firms that sell drugs to alleviate anemia, which are Amgen, Roche and Johnson & Johnson. The government's Medicare program currently spends over $2 billion a year for these drugs.

The current roster on the NKF website lists 12 of 18 members with ties to those three firms. ...

In an article in the current issue of the Clinical Journal of the American Society of Nephrology, Daniel W. Coyne of Washington University School of Medicine in St. Louis blasted the committee's decision last year to ignore his own unpublished data showing excess mortality even though he offered the data from his industry-funded study to the committee. 'In whose interest was it not to delay release of the guidelines until the results of these studies were available,' he asked. In a written response, five physicians from the committee, four with ties to the drug makers, said reviewing only published studies 'served as a safeguard against bias.'

Coyne also attacked Medicare reimbursement policy, which rewards dialysis clinics for increased use of the drugs, and called on NKF to prohibit or 'greatly limit' physicians with conflicts of interest from serving on its guideline-writing panels. 'There are many physicians in academia with few or no ties to industry who are well trained to evaluate evidence from clinical trials and capable of writing guidelines,' he told Integrity in Science Watch. 'By not restricting corporate conflicts of interest among guideline panel members, the NKF has sometimes chosen physicians clearly favored by their sponsoring corporations, and effectively encourages those companies to attempt to influence all panel members.' In the written response to his article, the NKF committee members said prohibiting physicians with conflicts from sitting on the panel 'although attractive in theory, is unrealistic.' They called instead for greater transparency."

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January 29, 2007

Canadian Cancer Society & Pharma Funding

The Canadian Cancer Society proclaimed last week "National Non-Smoking Week," and CBC radio covered the topic on its program, "The Current."

The program's website stated: "The Canadian Cancer Society is one of the voices you'll be hearing from this week. The organization has just published an updated version of its "How-To" guide to quitting smoking ... a book called One Step At A Time.

Among other things, the new version contains information about smoking-cessation devices ... nicotine patches and chewing gum meant to help deal with nicotine withdrawal. Ordinarily, that wouldn't be cause for concern. But some health policy specialists are suspicious about the fact that some of the money behind the revised guide came from the pharmaceutical giant, Pfizer ... a company that has made many of the products the Canadian Cancer Society's guide promotes. ...

Nicotine replacement products are a booming business. For about fifteen years now, repentant smokers have been able to buy over-the-counter products like nicotine-laced gum and skin-patches. And the makers of those products have boldly promoted their virtues in commercials featuring a flight attendant on the edge.

Commercials such as these can give you the impression that it's just about impossible to quit smoking without medication."

Drug company funding of "disease awareness" or patient education campaigns can be problematic. On this radio program, University of Victoria drug policy researcher Alan Cassels (whose Media Doctor website operates much like our HealthNewsReview.org website) explained where the problems may lie.

You can download and listen to the entire program, using Real Player.

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January 25, 2007

MRI kickbacks

On this blog, we've followed stories that show how doctors' referral arrangements to MRI and CT scanning centers may make them rich while possibly violating the law. And we advised: "Think about that the next time you see a news story or an ad promoting the latest CT, MRI or PET scanner in your community. Follow the money. And then start to question whether all the scans are necessary."

Last week, the Wall Stree Journal (subscription required) reported on a whistleblower lawsuit that "details a widespread scheme among Chicago-area MRI operators to win referrals from doctors by allegedly signing the doctors to phony equipment lease deals that result in the physicians getting a kickback when they order scans for patients. ... The lawsuit strikes at an increasingly common arrangement between magnetic-resonance-imaging centers and doctors that is blamed for helping to fuel a staggering increase in the number of medical imaging tests done each year in the U.S."

This is a story worth following - in Illinois and across the country.

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January 3, 2007

Big Pharma Lecture Circuit discussion continues

Two days ago (January 1), I posted the contents of a letter to the editor of the Wall Street Journal from a physician criticizing the "Big Pharma Lecture Circuit." Today's WSJ has a response from another physician:

As a physician who occasionally lectures on behalf of industry, I must respond to Jon C. Bowersox's insulting comments ("Concerns About Big Pharma Lecture Circuit," Letters, Dec. 29), where he likens us to traveling snake oil purveyors of old.

Lectures done in the context of a pharmaceutical promotional event, such as a dinner, follow strict guidelines established by the FDA. They are anything but opinion-based -- data from pivotal trials is presented and recommendations cannot differ from those that have been FDA-approved and are contained in the package insert. Personal opinions may emerge during Q & A, but how is this a problem? Apparently, Dr. Bowersox thinks physicians who attend such meetings are dull clods and cannot make their own minds up about a specific recommendation.

And perhaps the good professor can explain how $2,500 for a lecture that often requires one or two days away from the office or hospital is an "outrageous fee?" It barely covers lost income.

Richard Amerling, M.D.
Editorial Board
Nephrology News and Issues
New York

Ah yes, the poor pharma-supported lecturer barely covering lost income. And where do patient interests fit into this discussion?

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January 1, 2007

Concerns About Big Pharma Lecture Circuit

The headline above is the subject line of a letter to the editor of the Wall Street Journal. It's an important message for the new year. It reads:

"Your article on how pharmaceutical companies use "medical education" to build new markets for existing products ("Drug Firm's Cash Sways Debate Over Test for Pregnant Women," page one, Dec. 13) proves that rhetoric still trumps science in influencing physician behavior. More than 100 years ago, traveling salesmen touted the miraculous benefits of patent medicines sold from the back of their wagons, even though there was no evidence to support their claims. Now, it is traveling professors collecting $2,500 for an hour's lecture, plus first-class tickets and accommodations, to deliver the same message. In an era where there is a national consensus that evidence-based medicine improves patient outcomes, it is appalling that physicians would take these outrageous fees to represent pharmaceutical companies based on beliefs and not data, sometimes pleading ignorance when required to sign financial-disclosure statements or claiming that it is on the behalf of patients.

It isn't the responsibility of the pharmaceutical industry to stop this behavior. Companies are obligated to maximize value for their shareholders. But physicians have a higher level of responsibility to their patients and families. The FDA has created a stringent review process for approving new drugs or new applications for an existing drug. To subvert this process not only puts patients at risk, but lowers the public trust in all physicians. Corporate executives now face criminal and civil penalties for misrepresentation. Physicians should be held to the same standards.

Jon C. Bowersox, M.D., Ph.D.

Professor and Vice Chairman
Department of Surgery
University of Cincinnati

(Dr. Bowersox was previously global director of medical affairs for a major American pharmaceutical company.)

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December 27, 2006

Conflict of interest in New England Journal editorial

The Wall Street Journal (subscription required) reports on another questionable editorial decision by the editors of the New England Journal of Medicine.

The WSJ reports: "The New England Journal of Medicine last month published studies warning that aggressive efforts to treat anemia in kidney-disease patients with the drug erythropoietin, or EPO, as recommended by the National Kidney Foundation, appear to increase the risk of heart failure and the need for dialysis. But the medical journal spiked an opinion piece commissioned from one of its senior writers that was critical of the foundation's reliance on multimillion-dollar donations from the companies that make such drugs.

The journal did run a less-critical editorial on the studies co-authored by Julie Ingelfinger, a nephrologist and deputy editor at the journal who is the immediate past president of the Massachusetts-based chapter of the National Kidney Foundation and a member of the state group's medical advisory board. The editorial that ran made no mention of the foundation's industry funding, and Dr. Ingelfinger's relationship with the foundation wasn't disclosed.

Meanwhile, the author of the spiked editorial, Dr. Robert Steinbrook, submitted it to one of the journal's chief rivals, the British medical journal Lancet, which ran a version on its Web site on Nov. 17, a day after the New England Journal published its reports on the matter.

Dr. Steinbrook's article said that the foundation's guidelines have been questioned because of the group's close relationship with the drug industry. The article also noted that in fiscal 2005, the foundation received more than half of its support from "corporate and organizational partners," and, in the calendar-year 2005, it received $4.1 million from Amgen Inc. and $3.6 million from Johnson & Johnson's Ortho Biotech, the current marketers of EPO in the U.S. Of the 18 members of the group that formulated the guidelines, two-thirds disclosed financial associations with Amgen or other EPO manufacturers or marketers, he noted.

Dr. Steinbrook commented that "given the billions of dollars at stake for the drug and dialysis, such guidance is likely to receive the broadest acceptance if developed without industry support and by experts without relevant financial associations."

The editorial that was published in the New England Journal also expressed doubt about the kidney foundation guidelines -- saying "these recommendations are not based on persuasive randomized, controlled trials" -- but made no mention of the industry funding of the kidney foundation."

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December 21, 2006

Cleveland Clinic MD conflict of interest story

The Cleveland Plain Dealer reports on a new case of apparent conflict of interest with an influential Cleveland Clinic surgeon.

According to the Plain Dealer, the surgeon "pioneered and promoted a new treatment for spinal fractures after he was offered valuable stock options in the company that made the equipment used in the procedure. ... (This) provides another local chapter in what is playing out as a national saga: The potential for conflict between physicians' financial interests and their duties to patients."

The paper reports that the Clinic says the surgeon did not tell his patients about his financial conflict of interest unless asked. Meantime, the paper explains, "records indicate that there has been a disproportionate increase in reported deaths nationally associated with the procedure (called kyphoplasty) in the last three years."

Penn bioethicist Art Caplan is quoted: "This is a classic tale of why you wind up with a lot of technologies that are marginally better or turn out not to be better at all than what you already had - because you rely on reports from innovators who have economic dogs in the fight."

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December 20, 2006

Push for herpes testing = push for herpes drug use?

It's another story of questionable promotion of a screening test, of "off-label" promotion of a drug, of risk-benefit decisions, and of behind-the-scenes drug company wrangling for broader use of one of its drugs.

The Wall Street Journal (subscription required) reports on a controversial push by some doctors for testing all pregnant women for genital herpes to reduce infections in newborns. Of course, it would also mean a boost for GlaxoSmithKline, which has a herpes drug, and which supports the "continuing medical education" lectures promoting the screening.

The WSJ reports: "Advocates of screening point to a stark reality: Babies born to a woman whose herpes infection is active can end up blind or with cerebral palsy, and some die. An estimated one-quarter of pregnant women in the U.S. carry the herpes virus in their bodies.

Yet only a small fraction of these women are at any risk of passing the virus to their babies. It's not clear whether treating infected women with herpes drugs would reduce this number. Meanwhile, most pregnant women who have the virus don't even know it. And they aren't routinely tested to find out.

Federal health agencies that have studied the possibility of universal screening of pregnant women for genital herpes have come down against it. So has the American College of Obstetricians and Gynecologists. Opponents see little benefit but potential risks if large numbers of women tested positive and began taking herpes drugs. Their side effects can range from allergic reactions to hypertension.

Glaxo says it doesn't market its herpes drug, called Valtrex, in any way for pregnant women. The company couldn't promote the drug to prevent neonatal herpes in any case, because the Food and Drug Administration hasn't approved it for that purpose.

Doctors, however, aren't restricted in how they use an approved drug, nor in what they can say about it in talks to other medical professionals. And currently, about 10 doctors are fanning out across the U.S. making the case for universal genital-herpes screening of pregnant women. Glaxo funds these talks by giving grants to hospitals and other institutions that host them."

One Ob-Gyn in the story said, "A screening program will be horribly inefficient and almost entirely ineffective and highly cost-ineffective. There are a few people who have made careers out of neonatal herpes and they are the ones pushing screening."

It's a messy story, well-reported by the WSJ.

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December 13, 2006

Waiving conflict of interest on FDA panels

The Center for Science in the Public Interest (CSPI) reports on multiple waivers of conflicts of interest on three recent FDA advisory panels. Three experts with financial conflicts were allowed on this week's advisory panel on adult suicide risk from antidepressants. According to CSPI, one received between $10,000 and $50,000 per year from one of the companies affected by the panel hearing.

Last week, seven waivers were granted to members of a panel discussing safety concerns about Sanofi-Aventis' antibiotic Ketek.

And the FDA gave financial conflict-of-interest waivers to six physicians who sat on the advisory panel that evaluated the safety of drug-eluting stents made by Johnson & Johnson and Boston Scientific.

CSPI does a tremendous public service by disclosing what's going on at the FDA. The public - and many journalists - don't know the extent to which conflicts of interest may impact the integrity of science and of health care recommendations. We need to have a deep and ongoing public discussion about what these conflicts mean, how to judge them, and how to ensure unbiased review of new drugs and devices given the prevalence of conflicts of interest among America's physician-researchers.

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December 4, 2006

Profit and Questions on Prostate Cancer Therapy

The New York Times reports on a trend of urologists purchasing I.M.R.T. radiation therapy equipment, and suggests that the expanded use may due to the fact that doctors can make much higher profit using this technology than doing surgery. I.M.R.T.stands for intensity modulated radiation therapy. The Times reports, “Critics see a potential conflict of interest on the part of urologists, the specialists who typically help prostate patients choose a course of treatment. The critics say that urologists who can profit from the new form of therapy may be less likely to recommend other proven approaches, which for some older men can involve forgoing treatment altogether. …But because there is little research directly comparing I.M.R.T. with the other treatments, there is little consensus among urologists about which approach is best. … The one certainty about I.M.R.T. is that for doctors who own the technology, it can be much more lucrative than alternative treatments. Medicare and other insurers typically pay urologists only $2,000 or less for performing surgery to remove the prostate or for implanting radioactive seeds. The insurers say the much higher I.M.R.T. payments, which in some cases exceed $50,000, are based on the technology’s cost.?

Wouldn’t it be interesting to hear the “shared decision-making? discussion between physician and patient when IMRT is brought up as the recommended treatment option?

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November 28, 2006

Conflicts of interest in American Diabetes Association?

The New York Times raises old and new concerns about non-profit health organizations selling out to corporate interests. The Times reports:

"Many public health charities, from the American Heart Association to the Lupus Foundation of America, raise money from businesses. But for the American Diabets Association, and some other charities, the effort has increasingly become an exercise in balancing the need to raise money with core matters of conscience.

'We tightened things up,' Dr. Richard Kahn, a top A.D.A. executive, said of the association’s new guidelines for corporate fund-raising, 'because we were beginning to be bombarded by all kinds of food companies selling all kinds of products with requests to be a ‘proud sponsor’ or to advertise.'

Some consumer and food activists say the guidelines, while good, do not go far enough.

They say the A.D.A. remains too wedded to benefactors in the food and pharmaceutical industries, who provided more than $23 million last year.

Of particular concern: a three-year, $1.5 million sponsorship deal with Cadbury-Schweppes, the world’s largest confectioner. Under the deal, which meets the new guidelines, Cadbury is promoted as an A.D.A. sponsor in several settings, and has permission to use the A.D.A. logo on its Diet-Rite sodas, Snapple unsweetened tea and Mott’s Apple Sauce, among other products.

Critics say the A.D.A. affiliation has helped Cadbury pose as a concerned corporate citizen, even as it supplies grocery stores with sugary and fattening foods like Dr Pepper and the Cadbury Creme Egg.

'Maybe the American Diabetes Association should rename itself the American Junk Food Association,' said Gary Ruskin, director of Commercial Alert, a consumer advocacy group.

Others remain concerned about the A.D.A.’s relationships with pharmaceutical companies. Their presence is evident throughout the charity, from its annual convention, which is largely underwritten by drug makers, to its board meetings, where pharmaceutical executives have served on the volunteer committees that set policy."

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November 22, 2006

FDA Warns Against Guidelines Backed by National Kidney Foundation

From the Integrity in Science project at the Center for Science in the Public Interest:

"The New England Journal of Medicine last week published a Johnson & Johnson-funded clinical trial showing that patients with failing kidneys who were given high doses of Amgen's anti-anemia drug Epogen suffered 34 percent more heart attacks and strokes than patients given lower doses nearer to the FDA-approved standard. A comment that appeared in the Lancet online pointed out that the higher dose achieved in the study was within guidelines recently issued by the National Kidney Foundation, which received 57 percent of its $19.7 million budget in 2005 from corporate and organizational partners, including $4.1 million from Amgen and $3.6 million from J&J. Amgen and J&J compete with variants of Epogen sold as Aranesp and Procrit, respectively, in the oncology market. The Food and Drug Administration late last week warned physicians not to exceed agency-approved prescribing levels for Epogen, Aranesp and Procrit. "

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November 20, 2006

The Best Advice is Free – From Conflicts of Interest

The Center for Science in the Public Interest wrote the headline above for a statement CSPI issued last week.

The statement was written by CSPI Integrity in Science Director Merrill Goozner concerning U.S. Senate Bill 3807. He wrote:

"There are three crucial FDA advisory committee meetings coming up in December. One will discuss drug-eluting stents on December 7-8; one will discuss antidepressant use and adult suicidality on December 13; and one will discuss the antibiotic Ketek on December 14-15.

Nothing in S. 3807, the FDA reform bill sponsored by Sen. Mike Enzi (R-WY) and Sen. Edward Kennedy (D-MA), would require the scientists who will sit on those panels to be free from financial ties to the manufacturers of those products. This is unacceptable.

The scientists who advise the FDA should be free of all financial ties to firms whose products are under review. The public’s faith in the integrity of the process will be undermined by any reform legislation that allows physicians and scientists with conflicts of interest to continue serving on these committees."

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October 27, 2006

Questions about NIH guidelines on aggressive statin use

A team from the University of the Michigan and the VA question the National Institutes of Health guidelines that call for aggressive cholesterol lowering in people at high risk of, or who have already suffered, heart attacks and strokes. In a review in the October 2006 Annals of Internal Medicine, three researchers write that the "current clinical evidence does not support" the idea that aggressive statin therapy to achieve very low cholesterol levels for high-risk people "is beneficial or safe."

Of course, the guidelines in question are the ones for which eight out of nine guideline authors had financial ties to manufacturers of statin drugs.

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October 3, 2006

Smell fishy? Taste salty? Conflict of interest, perhaps

The Center for Science in the Public Interest reports that "The Journal of the American College of Nutrition's June supplement on sodium intake and human health failed to reveal that its editor and several authors had long-standing ties to the food industry. Then, in violation of the National Library of Medicine's rules, the editors allowed MEDLINE to index the supplement."

A CSPI news release also states: "In a letter to JACN, CSPI demanded that the next issue contain a formal apology to readers, full conflict-of-interest disclosure information for all authors and a prominent notice that the supplement did not undergo peer review. In a separate letter to the National Library of Medicine, CSPI requested that the abstracts be withdrawn from MEDLINE since the journal failed to follow NLM policy. The agency recently ruled that privately-sponsored journal supplements must contain conflict-of-interest disclosures for all authors and editors before they can be indexed in the government-funded database."

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September 12, 2006

High level NIH conflict of interest

An internal audit by the National Institutes of Health criticizes one of its senior cancer researchers for "serious misconduct," according to the Los Angeles Times.

The Times reports that Dr. Thomas J. Walsh entered "into dozens of unauthorized private arrangements with drug companies ... failing to report annually the outside income, totaling more than $100,000. ... The internal review, conducted by lawyers and other ethics specialists within the office of the NIH director, found that from 1999 to 2004, Walsh received fees totaling $100,970 from pharmaceutical and biotechnology companies. He accepted fees from 25 companies and has led government-sponsored research involving some of those companies' drugs."

The Times says a congressional hearing this week is expected to review NIH's handling of the Walsh case and that of another senior NIH researcher, Dr. P. Trey Sunderland III. The Times adds: "Sunderland, who has specialized in researching Alzheimer's disease, accepted hundreds of thousands of dollars in drug-company fees — including about $612,000 from Pfizer — without obtaining required advance approval. In June, Sunderland asserted his 5th Amendment right against self-incrimination while declining to answer questions before the congressional subcommittee. Neither Sunderland nor Walsh has been publicly disciplined, and each maintains his senior government position."

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September 5, 2006

Does FDA approval mean safety?

The National Research Center for Women & Families released a report that suggests a lot of FDA rubber-stamping of approval of new medical devices and drugs.

A news release on the group's website quotes Center president Dr. Diana Zuckerman:

"From our analyses of the FDA advisory committee voting patterns and committee discussions, our study shows advisory committee members usually recommending approval, even if they have strong concerns about the products' safety and effectiveness. And, on those rare occasions that the advisory committee opposes approval, the FDA frequently approves the product anyway. That is especially likely for medical devices." ... "Our study indicates that even one committee member with a financial conflict of interest could easily influence the votes of the entire committee, and thus the FDA decision to approve the product."

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August 29, 2006

Journal conflicts of interest continue

The Wall Street Journal reports that the editor of the journal Neuropsychopharmacology, Charles Nemeroff, resigned after he wrote a favorable review of a new device for treating depression that didn't disclose his financial ties to the device's maker.

WSJ reports: "The journal, which carried the article, has published a correction citing Dr. Nemeroff's ties to the device maker and those of the article's other eight authors. In addition to Dr. Nemeroff, seven of the authors were academics who serve as consultants to the maker of the device, and one was an employee of the company, Cyberonics Inc., of Houston. The authors' relationships to Cyberonics were reported in The Wall Street Journal last month. Last month, the journal published a review in which it said the Cyberonics treatment, in which a small device is implanted in the chest to deliver mild electrical pulses to the vagus nerve in the neck, is 'a promising and well-tolerated intervention that is effective in a subset of patients with treatment-resistant depression.' "

As I teach students, I use the term "rampant" to describe the entanglement of conflicts of interest in the dissemination of health and medical news. Since many journalists live off what they get in medical journals, this is further evidence of how rampant the spoiling of the food chain is.

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August 10, 2006

Health care conflict of interest down under

Two recent Australian news stories point to conflicts of interest in Australian health care.

One, "Doctors have unhealthy desire for gifts," discussed a survey of 823 medical specialists about what companies gave them and what they asked for. The lead author concluded, "Doctors are sometimes seen as the innocent victims, and the villains in the piece are the pharmaceutical industry. In reality, it is a two-way relationship."

The other story, "Mental health takes industry pills," reports that Australia's "most influential mental illness advocacy group signed a deal that financially tied it to some of the world's biggest pharmaceutical companies." A spokesman for the group called Healthy Skepticism reacted: "The strategy is all about growing markets and increasing sales."

These are two important stories that may only give you the twisted satisfaction that we're not alone in our entanglement of conflicts of interest in U.S. health care.

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August 3, 2006

Awesome Aussie Example of Pharma Largesse

Ray Moynihan gives us an inside look at one drug company's wining and dining of top doctors in The Australian. Excerpts:

"It was a glamorous Saturday night out in Sydney. The restaurant, the food, the wine and the calibre of guests were all first-class. The exclusive Guillaume at Bennelong restaurant sits atop the stairs at the Sydney Opera House, commanding one of the best views in the nation.

The restaurant's enticing degustation menu includes multiple courses, each served with a glass of one of the world's best wines, creating an unforgettable dining experience.

Among the 278 diners were some of the nation's top cancer specialists from our leading public hospitals. Some had brought partners, some were alone. All were there as guests of Swiss drug giant Roche Pharmaceuticals. At a cost of more than $65,000, Roche had booked out the restaurant and thrown a $200-a-head feast for the doctors.

"The gluttony of the whole thing was mind-blowing," says Karen McLeod, the former partner of one attending doctor. ...

Roche is officially arguing that the $200-a-head dinner was simple and modest. ...

Roche has quite an interest in blood disorders and cancer. Its top-selling drug in the world is MabThera, a cancer treatment for non-Hodgkins lymphoma, which costs almost $10,000 a treatment."

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July 26, 2006

Medical journals, drug ads and reform

The journal PLoS Medicine has re-opened the discussion of medical journal policies for dealing with industry in a new editorial. The journal reminds readers: "In PLoS Medicine's launch issue in 2004, we declared that we would not be part of 'the cycle of dependency that has formed between journals and the pharmaceutical industry'. We set out three policies aimed at breaking this cycle. First, we would not publish adverts for drugs and devices. Second, we would not benefit from exclusive reprint sales to drug companies, since our open access license would let readers make unlimited copies themselves. Third, we would decline to publish studies aimed purely at increasing a drug's market share."

When a recent policy paper in PLoS Medicine called for other medical journals to follow that example and ban ads for drugs and devices, a group of advertising agencies and public relations firms representing the pharmaceutical industry called this a “goofy idea.?

The discussion is healthy, not goofy. With so many recent instances of fraud on the part of scientists submitting papers to journals, and instances of failure to disclose conflicts of interest by authors, there is an erosion of trust at stake.

Read the PLoS Medicine editorial and educate yourself on some of the serious issues at play.

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July 24, 2006

Are National Academy of Science panels fair & balanced?

A new report from the Center for Science in the Public Interest questions the integrity of panels appointed by the National Academy of Sciences.

A CSPI news release reads, in part: "Congress created the National Academy of Sciences (NAS) to provide independent, science-based advice to policymakers in government. But according to a year-long review of 21 NAS committees conducted by the nonprofit Center for Science in the Public Interest (CSPI), nearly one out of every five scientists appointed to an NAS panel has direct financial ties to companies or industry groups with a direct stake in the outcome of the study. And about half of the panels examined had some scientists with readily identifiable biases who were not offset by scientists with alternative points of view. ...

CSPI released its report the day of a panel discussion it organized in Washington where representatives from the FDA, industry groups, and academics debated conflict-of-interest issues on panels at federal agencies and the NAS.

Legislation that would bar scientists with financial ties to drug makers and medical-device companies from serving on FDA advisory committees, sponsored by Rep. Maurice Hinchey (D-NY), passed the House in May and will be considered by a conference committee in the fall."

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July 21, 2006

Erosion of trust in medical journals

The editor of the Journal of the American Medical Association says that for the third time in three months, the Journal was misled by authors failing to disclose their ties to drug companies. This time it was in a study appearing in this week's Journal linking migraines to heart attacks in women. All six authors of the study have had financial ties to drug companies making products for migraines or heart problems.

The Associated Press reports that "the authors said they did not report their financial ties because they did not believe they were relevant to the study."

JAMA was burned last week when authors of a depression study failed to report their connections to drug companies making antidepressants. And two months ago authors of a study on arthritis drugs and cancer failed to fully disclose.

The engtanglement of conflicts of interest in the dissemination of health, medical and science news is worsened when journalists don't question researchers about potential conflicts of interest, or when they take as gospel anything that is published in a journal. Consumers are hurt when there is not full disclosure. They're not getting the full story. That's why, on our HealthNewsReview website, we give an "unsatisfactory" score to any news story that fails to pursue questions of conflicts of interest in the sources used in a story.

This situation must change.

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July 18, 2006

Hospital execs' conflict of interest questions

With all of the attention given to doctors' dealings with drug companies, let's not forget that hospital execs may have some shenanigans of their own. Yesterday, Walt Bogdanich of the NY Times, in a story headlined "Hospital Chiefs Get Paid for Advice on Selling," told the story of hospital executives benefiting from payments made by companies their hospitals do business with. Similar to the MD-Pharma story, this one has posh resort settings, big payments for little time commitment, etc.

The "institute" created to arrange such meetings once shunned the journalist's inquiries. They denied that any hospital exec member made as much as $50,000 a year from the "advice consultations," then later revealed that indeed payments did reach that high.

Great story, revealing another troubling area of conflict of interest in health care.

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July 5, 2006

Doctor-run charities and conflict of interest

The New York Times last week had an excellent front-page story on another troubling area of conflict of interest in health care and medical research.

Read the story to learn more about tax-exempt "charities" that, according to the Times, "are typically set up to engage in medical research or education, and the doctors involved defend those efforts as legitimate charitable activities that benefit the public. But because they operate mainly under the radar, the tax-exempt organizations represent what some other doctors, as well as regulators and industry consultants, say is a growing conduit for industry money. The payments, they say, can bias the treatment decisions of physicians, may lead to suspect research findings and at times may even risk running afoul of anti-kickback laws."

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June 19, 2006

TIME magazine fails to disclose glaring conflict of interest

What ethical standards still exist at Time magazine? Or do they exist and they're just being ignored?

The Center for Science in the Public Interest points out that this week's Time magazine includes a column by Dr. Andrew Weil touting the benefits of fish oil supplements. CSPI says, "The column was sparked by a recent report in the Journal of the American Medical Association showing that fish oil supplements did not reduce the risk of serious abnormal heart rhythms. The article failed to disclose that Dr. Weil sells his own brand of fish oil supplements on his website.

I've pointed out other questionable advertising-related editorial practices at TIME in the past.

Let the reader - and the buyer - beware.

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April 26, 2006

Hypertension drug panel stacked with industry consultants

The Center for Science in the Public Interest (CSPI) says the Food and Drug Administration’s (FDA) advisory committee on cardiovascular and renal drugs will be chaired by and dominated by industry-connected scientists when it meets today to evaluate draft labeling guidance for antihypertensive drugs. CSPI has urged the FDA to postpone the meeting to take the time to identify panelists who are free of conflicts of interest, and who could bring balance to the panel.

A balanced panel would at least have some members with expertise on how hypertension can be treated with diet and lifestyle changes, according to CSPI.

“American hospitals and medical school faculties are filled with experts on preventing and treating high blood pressure, and it is simply not the case that all of them have financial relationships with drug makers,? said Merrill Goozner, director of the Integrity in Science Project at CSPI. “If the FDA can’t find any to serve on this particular panel, we stand ready to help them identify some.?

CSPI also told the agency that its draft labeling guidance ignores the government’s own advice on the importance of lifestyle changes on lowering blood pressure, misrepresents the findings of the major government-funded science on hypertension, and would permit drug companies to make claims on drug labels that have not been reviewed by FDA. CSPI says that the labeling guidance would open the door for labeling abuse by letting drug companies tout the advantage of one drug over another without much evidence, and would squander and opportunity to educate Americans about the importance of diet and lifestyle in treating hypertension.

“The FDA acts as if it is much more concerned with pampering the pharmaceutical industry than it is preventing disease through better diets,? said CSPI executive director Michael F. Jacobson. “The best science on blood pressure shows that adoption of healthy lifestyles, including losing weight and reducing sodium, is indispensable to reducing blood pressure. Yet FDA does very little to help Americans make those changes.?

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April 21, 2006

Conflict of interest in psychiatry's "bible"?

For a long time there have been questions about how certain new mental disorders become classified in psychiatry's recognized "bible" of definitions - the DSM or Diagnostic & Statistical Manual.

Now a study reported in the New York Times shows that "more than half the psychiatrists who took part in developing a widely used diagnostic manual for mental disorders had financial ties to drug companies before or after the manual was published."

The study's lead author said that although the study could not prove that the psychiatrists' ties influenced the manual's development, "what we're saying is it's outrageous that the manual doesn't have a disclosure policy."

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February 20, 2006

Stink from fish studies in absence of full disclosure

According to the New York Times, the Harvard Center for Risk Analysis accepted a half million dollars from the Tuna Foundation to study the risks and benefits of hypothetical changes in fish consumption, but didn’t disclose Big Tuna as the primary funder of the work.

The study appeared in the November issue of the American Journal of Preventive Medicine.

The Times reports that “Critics say the failure to identify the source of the funding is a conflict of interest. Edward Groth, an environmental health expert retired from Consumers Union, said: ‘No matter how well they did their analysis, since an affected industry paid for it, its credibility is suspect.’ “

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February 19, 2006

How drug lobbyists influence doctors

Last week, Dr. Jerome Kassirer of the Tufts University School of Medicine, and author of ''On The Take: How Medicine's Complicity With Big Business Can Endanger Your Health,? had an op-ed piece under the headline above in the Boston Globe.

He wrote about what he called “corruptive influences in medicine.? For example: “The settlement of the $185 million class action lawsuit against Bristol-Myers Squibb announced at the end of January is a lesson in how physicians paid by the pharmaceutical companies as speakers and consultants can be hazardous to your health. While most of the attention of this suit focuses on how company officials defrauded investors by overly flamboyant predictions for the sales of the highly touted ''blockbuster" drug Vanlev, documents prepared for the suit show that behind the scenes, Bristol-Myers Squibb-paid physicians in major medical meetings were shamelessly exaggerating the benefits of the drug for patients with high blood pressure and heart failure and failing to report publicly on substantial numbers of life-threatening drug complications which they knew, from their close relationship to the company, to exist. Fortunately, the FDA saved hypertensive and cardiac patients from ever receiving Vanlev because it knew about the potentially fatal events, determined that they were excessive, and Bristol-Myers Squibb was eventually forced to withdraw its application to market the drug.?

Kassirer concluded: “It's about time that pharmaceutical companies cut back on their massive campaign to influence doctors and to use paid ''experts" to influence other doctors. It's about time physicians, academic medical centers, and professional medical organizations wean themselves away from the deep pockets of companies whose principal goal is not education but marketing.?

Meantime, USA Today last week reported that “at least nine states are considering bills that would require drugmakers to publicly report how much they and their sales representatives give to doctors, hospitals and pharmacists each year. A few proposals go further: A bill under debate in Massachusetts would ban all gifts to medical professionals from the drug industry. … Four states — Vermont, Minnesota, West Virginia and Maine — and the District of Columbia have laws requiring gift reporting by drugmakers. California requires that drugmakers declare they are compliant with federal and industry gift guidelines.?

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February 7, 2006

Questioning the independence of health advocacy groups

Freelance writer Tinker Ready delivers a terrific piece in the Washington Post about the ties between drug companies and nonprofit health advocacy groups.

She begins the piece: "Diabetes patients anxious to weigh the pros and cons of an experimental diabetes drug called muraglitazar might expect some help from the American Diabetes Association (ADA). But they won't find much on the ADA Web site.

For example, there is no information about research linking the drug to possible increased risk of fatal heart problems. Also, the Web site has yet to report that the Food and Drug Administration (FDA) approved the drug only on the condition that its maker, Bristol-Meyers Squibb -- which last year donated more than $1 million to the ADA -- produce additional safety data first. The diabetes group acknowledges financial support from the drug maker in its annual report and on a Web page called 'Corporate Health Ambassador Case Study,' but not the precise amount of the donation.

Similarly, if patients have questions on drugs for bone loss, they might think the National Osteoporosis Foundation (NOF) would help sort things out. But the NOF Web site doesn't get into the scientific debate over the long-term effects of Fosamax, the most popular osteoporosis drug on the market. Merck, the maker of Fosamax, is a longtime NOF donor, and it's named in NOF's annual report. But the organization does not disclose how much it gets from Merck and other supporters."

Read the whole piece. It highlights another example of the entanglement of conflicts of interest in the dissemination of health and medical news and information in this country.

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January 25, 2006

Conflicts of interest in academic medical centers

A group of top health care thought leaders published a plan in this week's Journal of the American Medical Association for academic medical centers to "take the lead in eliminating the conflicts of interest that still characterize the relationship between physicians and the health care industry."

The group writes: "Although physician groups, the manufacturers, and the federal government have instituted self-regulation of marketing, research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients. More stringent regulation is necessary, including the elimination or modification of common practices related to small gifts, pharmaceutical samples, continuing medical education, funds for physician travel, speakers bureaus, ghostwriting, and consulting and research contracts."

But Merrill Goozner at the Center for Science in the Public Interest, who has tackled health care conflict of interest questions since leaving newsroom journalism, writes in his blog that the group didn't go far enough. For example, he writes: "First, by focusing on the nation's academic medical centers, they ignore the fact that most of the drug and device industries' marketing practices are aimed at the nation's nearly one million practicing physicians, not the elite in the nation's medical schools. ... Moreover, the practice of medicine is heavily influenced by clinical practice guidelines written by professional associations or patient advocacy groups like the American Society of Clinical Oncologists or the American Heart Association. ... While many academicians sit on these guideline writing committees and most groups have strong conflict-of-interest disclosure requirements, industry exerts extraordinary influence over the guidelines either through direct funding of these groups or ongoing relationships with members of the guideline-writing committees. This proposal does nothing to liberate the writing of clinical practice guidelines from industry influence."

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December 12, 2005

Cleveland Clinic's stunning conflict of interest story

The latest evidence of the rampant conflicts of interest in big monied big American health care is in the Wall Street Journal today.

The Cleveland Clinic for years has touted a procedure for atrial fibrillation, calling it the "AtriCure procedure," after the maker of the equipment used in the surgery. But the Journal reports:

"The Clinic's relationship with AtriCure, however, goes deeper. A venture-capital partnership that the Clinic helped found and invested in owns about 4.1% of AtriCure's stock, valued at about $7 million. The Clinic's chief executive, heart surgeon Delos "Toby" Cosgrove, sat on AtriCure's board of directors until March. He also invested personally in the fund and was one of the general partners managing it until, according to a Clinic spokeswoman, he cut his ties to the fund at the end of October.

In addition, Dr. Cosgrove will be entitled to royalties for a medical device he developed that AtriCure plans to begin selling next year. Marc Gillinov, another Clinic surgeon who performs the AtriCure procedure, is a paid consultant to the company, as is another doctor who recently left the Clinic.

The Clinic didn't disclose these ties to AtriCure to the patients on whom it performed the AtriCure procedure. The venture fund the Clinic helped found has also invested in two other medical companies conducting clinical trials at the Clinic."

In addition, the Journal reports that one of the Clinic physicians who questioned the ties -- famed cardiologist Eric Topol -- was told last week that he would be removed from the Clinic medical school's top post and from the conflict-of-interests committee.


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September 26, 2005

Doctors' ties to device makers

There has been growing attention given to the undue influence drug companies may have on some doctors. But conflicts of interest with industry don't end there.

A New York Times editorial reminds readers that many surgeons have financial ties to device manufacturers -- something that is often not revealed to patients or to hospitals. The editorial states: "These connections raise questions as to whether some doctors are choosing devices primarily for the good of their patients or primarily for the benefit of their own bank accounts."

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September 9, 2005

More potential conflict of interest in FDA drug review

The Center for Science in the Public Interest reports that the Food and Drug Administration (FDA) is again allowing scientists with direct financial ties to a drug manufacturer to serve on an advisory committee charged with evaluating that company's product.

CSPI says that a committee reviewing the safety and efficacy of Pfizer's proposed insulin inhaler has at least three members with direct ties to Pfizer, the product's manufacturer, or its technological partner, Nektar Therapeutics. One other member-the acting chairman-holds stock in Pfizer.

"The public's faith in the integrity of the process is undermined when one-third of an advisory committee's membership has significant financial ties to the company seeking the product's approval," said Merrill Goozner, director of the Integrity in Science project at CSPI. "It is ludicrous that the FDA could not find highly qualified experts in these fields who did not have ties to the manufacturer."

Posted by schwitz at 9:10 AM | Comments (0)
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August 30, 2005

Disclosure of drug company gifts to doctors

A Vermont court should order the states attorney general to allow public access to all records disclosed by pharmaceutical companies under the Vermont Pharmaceutical Marketing Act, a law intended to allow the public to learn the amount of money doctors receive from drug manufacturers, Public Citizen said in a lawsuit filed Friday against the Vermont attorney general. The lawsuit, which calls for the release of records being withheld at the request of drug companies, was filed in Vermonts Washington County Superior Court.

Posted by schwitz at 8:31 AM | Comments (0)
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August 22, 2005

Industry ties cloud research

The Mercury News of San Jose is the latest to look at issues of bias in drug studies - bias introduced by researchers' financial ties to industry.

The News writes: "Earlier this year, an herbal supplement called FertilityBlend got a glowing endorsement from a prominent Stanford researcher, an author of two small studies that showed it increased pregnancy rates in infertile women.

``I think my opinion of herbal supplementation has changed. I was a skeptic,'' says Dr. Mary Lake Polan, chairwoman of Stanford's department of obstetrics and gynecology, in a video on the Web site of the product's manufacturer. But after one-third of the women taking the pills in the study got pregnant, she became a believer, she says.

What many consumers may not realize is that Polan also has a financial interest in the Mountain View company that makes the product -- and that such relationships between academic scientists and industry are increasingly common."

The article continues: "Critics believe the growing number of monetary relationships between scientists and companies that make drugs, supplements and medical devices could be tainting research and compromising patient care, and some are pushing for tighter regulations on such financial ties."

Posted by schwitz at 10:54 AM | Comments (0)
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August 16, 2005

Doctor/"reporter" sells cream on QVC


The Pittsburgh Post-Gazette reports that a KDKA-TV medical "reporter," who is a physician, was "peddling Joint Formula 88 joint pain relief cream ($21.90) on QVC." Worse, if it can get worse, is that the cream is his product.

Did anyone talk to this guy about journalism ethics before hiring him?

I just spoke to a group of California journalists about the entanglement of conflicts of interest in the dissemination of health news and information. My recurrent message to them is what I would tell this "M.D.-reporter" -- YOU HAVE TO DECIDE WHETHER YOU'RE GOING TO BE A JOURNALIST OR A PR-ADVERTISING PERSON. You can't do both.

Add this egregious example to the long list of commercialism and conflict of interest incidents in journalism which I previously reported.

Posted by schwitz at 7:56 AM | Comments (0)
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August 6, 2005

Can't mix news and PR jobs

This is becoming a recurring theme: journalists working in news rooms while also doing paid public relations work.

A Minneapolis-St. Paul TV anchor did it.

A Nashville TV reporter did it. (Although she called me yesterday to explain that she's not doing it anymore.)

And now Detroit Medical Center announced that it has named a former WDIV-TV anchorman to be its communication director, "providing guidance on media issues and serving as a principal spokesperson" for the medical center. That's fine. But in the next breath, it's revealed that the anchorman also has a long-term agreement with WDIV-TV to produce periodic in-depth documentaries for this Detroit-based NBC affiliate.

How does the audience know which hat the anchor/PR man is wearing at which times?

As critics said at the time of the Minneapolis incident cited above, journalists who cross these lines between journalism and public relations raise warning flags. Questions of credibility, conflict of interest (real or perceived), and truthfulness arise when you're being paid by someone to make them look good in the media -- at the same time you're supposedly being an independent, objective journalist in other venues.

Posted by schwitz at 8:31 AM | Comments (1)
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August 1, 2005

Drug company influence causes scientific split

A group of high blood pressure researchers is ending its 16-year relationship with a high blood pressure journal, and claims of improper drug company influence on doctors are at the root of the dispute.

The Wall Street Journal has details.

Dr. John Laragh, co-founder of the American Journal of Hypertension, complains that some doctors have become "heavily involved in pharma marketing for personal gain."

As the Journal appropriately frames the story, it is "a dispute reflecting heightened concerns about the control and credibility of medical information."

Posted by schwitz at 9:18 AM | Comments (0)
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April 29, 2005

Bucking the "buckraking" trend

Journalist Merrill Goozner rants about journalists accepting speaking fees from entities they cover.

He talks about an upcoming Las Vegas convention of health insurers, at which journalists from PBS, Fox, and the New Yorker will speak. He writes that one "talk is sponsored by Schering-Plough. Each of the other sessions is supported by major health providers Merck-Medco, AstraZeneca, Sanofi-Pasteur, Amgen. The insurance companies' annual meeting, it turns out, is sponsored by their contractors, the companies whose fees they're supposed to hold down. I guess it's all one big happy family."

Posted by schwitz at 7:34 AM | Comments (0)
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April 8, 2005

Conflict of interest in breast implant panel?

The following is an excerpt from a statement by the Center for Science in the Public Interest:

As The Washington Post reported in 2003, Dr. Michael Miller has taken $25,000 from breast-implant maker Inamed to help produce an educational CD-ROM about breast reconstruction surgery. We are extremely disappointed that the FDA chose to overlook this conflict of interest. It's also distressing that the panel is so unbalanced by the inclusion of four plastic surgeons, who financially benefit from the use of these devices. As the chairman of the last committee wrote to FDA chairman Mark McClellan after that vote, "It just does not play well in Peoria."

The Federal Advisory Committee Act requires that committees be balanced with regards to points of view. With plastic surgeons constituting four of 12 voting members on this committee, their votes may once again determine the outcome of the vote. The imbalance is exacerbated by the fact that only one person on the committee is expert in the diseases that may result from ruptured silicon gel breast implants.

Posted by schwitz at 7:33 AM | Comments (0)
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February 25, 2005

Conflicts of interest continue

Another report of conflicts of interest in FDA drug deliberations may not be surprising.

Ten of the 32 government drug advisers who last week endorsed continued marketing of the pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records. Take away their votes and the committee would have voted to keep Vioxx off the market and to withdraw Bextra.

Posted by schwitz at 9:08 AM | Comments (0)
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