June 3, 2009

Did singer Natalie Cole get priority for a kidney transplant?

Forbes reports that singer "Natalie Cole bypassed thousands of people to get an organ." Excerpt:

"There are nearly 80,000 people on the wait list for a kidney transplant, according to the United Network for Organ Sharing. So how did Natalie Cole, the Grammy-award winning singer, receive an organ on May 26, bypassing thousands of people?

It doesn't hurt that Cole drummed up public sympathy by appearing on Larry King to discuss her time of need, which yielded thousands of offers. (She ended up getting a transplant from a deceased donor match.) It may seem outlandish but it's nothing out of the norm -- the phenomenon was recently mocked on an episode of 30 Rock that detailed a "Kidney Now" benefit."

Posted by schwitz at 4:59 PM | Comments (0)
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June 2, 2009

On The Media on medical journal madness

The NPR program has now posted its transcript of last weekend's segment on Merck's fake journals - with guest Dr. Peter Lurie of Public Citizen explaining how journal publishers and drug companies work together.

Posted by schwitz at 1:03 PM | Comments (1)
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April 24, 2009

UK bioethics panel explores marketing of screening tests

Science reports:

"Ordinary folk can now try to be masters of their own health, as private companies offer online DNA tests and full-body CT or MRI scans. But these services, which often offer health information without a doctor’s guidance, have stirred up much controversy in the medical community, with claims that the results the companies provide can be inaccurate or misleading to the average layperson. In response to this issue, the U.K.’s Nuffield Council on Bioethics launched a consultation today on the ethical, legal, social, and economic issues behind these commerical health services."

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April 3, 2009

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."

Posted by schwitz at 1:29 PM | Comments (1)
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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

Medical Schools' Faustian bargain With Pharma

Duff Wilson's NYT piece is a good read.

"Harvard Medical School in Ethics Quandary."

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February 9, 2009

Ghostwriting debate

The journal PLoS Medicine offers an online debate on the practice of ghostwriting in medical journals. Their background to the debate:

"Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products but hiding those contributions and instead naming academic physicians or scientists as the authors. To improve transparency, many editors' associations and journals allow professional medical writers to contribute to the writing of papers without being listed as authors provided their role is acknowledged. This debate examines how best to tackle ghostwriting in the medical literature from the perspectives of a researcher, an editor, and the professional medical writer."

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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 OUR PATIENTS
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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September 24, 2008

More on editorial bias against publishing negative results

A study published in the journal Oncology found less than one in five cancer clinical trials registered in the government database ClinicalTrials.gov wind up in medical journals. The authors conclude:

"Our findings raise concern about the completeness of the available information on present and future cancer treatments. If selective publication has altered the apparent risk– benefit assessments of cancer treatments, doctors and their patients may not be making treatment decisions that are in their best interest."


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We don't get all the bad news from drug trials

A new study published in PLoS Medicine suggests that more than half the clinical trials to support drug approval remain unpublished 5 years or more after FDA approval. The journal editors summarize:

"(These findings) also reveal selective reporting of results. For example, they show that a pivotal trial in which the new drug does no better than an old drug is less likely to be published than one where the new drug is more effective, a publication bias that could establish an inappropriately favorable record for the new drug in the medical literature. Importantly, these findings provide a baseline for monitoring the effects of the FDA Amendments Act 2007, which was introduced to improve the accuracy and completeness of drug trial reporting. Under this Act, all trials supporting FDA-approved drugs must be registered when they start, and the summary results of all the outcomes declared at trial registration as well as specific details about the trial protocol must be publicly posted within a year of drug approval on the US National Institutes of Health clinical trials site."

Maggie Mahar blogs about the news of this study, offering some additional perspectives.

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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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June 26, 2008

Problems in bioethics

Two different news stories about problems in bioethics caught my eye this week. The Wall Street Journal reports:

"...as the number of hospitals with ethics consulting services has grown in recent years, so have questions about how qualified some of these professionals are to render life-and-death advice. The complex ethical issues arising from new life-prolonging medical technologies are throwing up new challenges. And hospitals face potential legal liability if patients and families feel they haven't been properly counseled or provided with all the information they need to make decisions."

On a quite different theme, Scientific American profiles the problems of one bioethicist at one center. Excerpt:

"When Glenn McGee founded the Alden March Bioethics Institute (AMBI) at Albany Medical College in New York State in 2005, magazine articles and newspaper stories hailed the arrival of the man once described as "Socrates with a beeper." Now, a month after his abrupt departure, former colleagues are painting a complex portrait that suggests the ethicist's own personal and professional relationships may have led to the institute's undoing.

McGee remains a tenured professor at AMBI, and neither he nor college officials will discuss the circumstances surrounding his change in status. Former colleagues, however, say the institute began to unravel shortly after his arrival when Union College in Schenectady, N.Y., severed its longtime educational partnership with AMBI's parent medical school and as disillusioned faculty—accusing the ethicist of everything from forgery to spreading insulting rumors—left."


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June 14, 2008

Were the data on Paxil suicide risk cooked?

The Wall Street Journal reports:

GlaxoSmithKline PLC faces new questions about whether it deliberately misrepresented data on suicide risk for its antidepressant Paxil when it applied for the drug's approval to the U.S. Food and Drug Administration at an advisory committee meeting in 1991, a charge the company has denied.

A study by a Harvard psychiatry instructor, underwritten by plaintiffs' lawyers and previously kept under seal by a court order, says that Glaxo "improperly" counted patients taking placebos during clinical studies. From 1989 through 1991, Glaxo then submitted information to the FDA that indicated no major difference in risk of suicidal behavior, or suicidality, as doctors call it, between patients who took Paxil and those who took a placebo.

However, Glaxo's counting minimized the differences between suicidality rates in the Paxil and placebo groups, according to the report. For instance, the company counted placebo patients who had attempted or committed suicide before the study formally started, which enhanced the results for Paxil.

The real risk for suicidality from Paxil, says the report's author, Joseph Glenmullen, was eight times its risk for patients on placebo. "Glaxo was aware of this risk, and hid it," Dr. Glenmullen's report states. The drug was approved for sale in the U.S. in 1992. Dr. Glenmullen said, in an interview Thursday, that if Glaxo had given the agency the "correct" data in 1991, the FDA would likely have added warnings about the risk for suicidality when it approved Paxil.

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June 4, 2008

Trojan horses sneaking ads into peer-reviewed journals

A recent letter to the BMJ identifies a troubling new practice. Geraint Lewis of NYU and Peter Hockey of Harvard Medical School write:

"Two research papers were published recently in the BMJ, neither of which stated its funding, competing interests, ethical approval, provenance or peer review status. Both papers extrapolated in- vitro data to clinical situations and made other potentially misleading claims. However readers of the journal were unable to post Rapid Responses to point out these shortcomings. The explanation becomes apparent on closer inspection: these "research papers" were in fact advertisements. We and several of our colleagues began reading them as legitimate BMJ scientific papers and only later noticed the light blue header stating "Advertisement Feature". trojan_horse.jpg

We all feel misled. The company paying for these adverts has effectively purchased "academic copy" in a high-impact journal, bypassing the peer-review process and using the reputation of the journal as a Trojan horse to catch our attention. In doing so it has made it impossible for us to follow Richard Smith's advice to "flip over the adverts in the journal." Of more concern is the fact that we, like many readers, sometimes skim-read articles without poring over the details. We do this because we trust the BMJ to scrutinize articles on our behalf. These adverts pose a danger because skim-readers may turn to the next page of the journal without realizing that they had just read an advert rather than peer-reviewed research.

... Surely every page of the journal should be subject to all of the same rigorous standards that editors rightly set for scientific research.

...The option, which to our mind is the only workable solution, is a complete ban on pharmaceutical adverts in peer-reviewed journals. The publication of these two adverts, despite being calculatedly inconspicuous, has once again reopened the debate about whether medical journals should carry drug advertising."

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May 14, 2008

Concerns about clinical trial recruitment

A Wall Street Journal column offers some information and some caution about recruitment for clinical trials. Excerpt:

"Medical ethics experts warn there are still concerns when it comes to protecting participants, with alarming reports in recent years about deaths in clinical trials and persistent questions about conflicts of interest among researchers who have financial stakes in drugs or treatments. Karen Maschke, an associate for ethics and policy at the Hastings Center, a Garrison, N.Y., nonprofit bioethics research institute, warns that patients have to be sure that researchers aren't "overselling the benefits and playing down the risks." Recruiting should be carried out "so that it is clear there is no moral obligation to participate and people's decisions will be respected if they say no," she says."

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May 11, 2008

Getting "informed consent" for drug trials in poor countries

Merrill Goozner reports that the FDA decided that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration.

Why should you care? Gooz says this "increases the likelihood that more trials will go abroad and that more of them will not even be registered with the FDA, which makes them all but impossible to monitor."

Huge issue. And, as Gooz points out, one not reported by many news organizations.

Posted by schwitz at 9:36 AM | Comments (0)
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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.

TN_14-09-07_07.jpg

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 11, 2008

WSJ Health Blog Flogs Vytorin Again

Scott Hensley of the Wall Street Journal Health Blog just posted this:

Merck and Schering-Plough attempted to recreate information from a crucial meeting about a major study on cholesterol blockbuster Vytorin after a Congressional panel began an investigation, according to documents obtained by a Congressional subcommittee, the WSJ reports.

In a letter Friday, Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) asked why minutes of the companies’ ad hoc expert panel, which had met in mid-November, had been “created after the fact? in December. Spokesmen for Merck and Schering-Plough couldn’t be reached immediately by the WSJ for comment.

The minutes, circulated Dec. 19, a week after Dingell’s investigation began, suggest that the companies’ experts had agreed to move the goal post for the study, which would have made Vytorin and its sister drug Zetia look better. Internal company documents released by the House Commerce Committee, which Dingell chairs, include strong complaints from one of the study panel members. Click on image at right to see the documents.

“It was my understanding that there were no minutes or transcript of this meeting,? James Stein, a cardiac imaging expert at the University of Wisconsin, wrote in an email to Schering-Plough. (See his comment to the same effect in the margin of draft minutes that appears in the image above.) Some of the new minutes of the Nov. 16 meeting didn’t accurately represent his recollections or details of the debate during the meeting said Stein in an email to Schering-Plough.

“It was the decision of the company to change the endpoint,? Stein wrote in comments back to company about the minutes.

The companies had issued a press release on Nov. 19, shortly after the consultants’ meeting saying the outside experts recommended such a change, which is contrary to generally accepted scientific practice.

Earlier this month the Merck/Schering-Plough joint venture that sells Vytorin made public an email exchange with John Kastelein, the cardiologist who ran the study called Enhance, and who had objected to the proposed change in the endpoint for the study.

In March, Forbes’ Matt Herper laid out the challenge for Dingell’s panel posed by the creation of minutes from the meeting after the fact. The retrospective memo writing, he wrote, “could also make it more difficult for the companies to defend their own decision making with regard to the study.?

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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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April 1, 2008

More suggestions of drug company deceit on Vytorin

The New York Times adds more questions to the Vytorin drug data delay story. Excerpt:


"The lead outside investigator on a crucial trial of two widely used heart drugs said in an e-mail message last July that Merck and Schering-Plough, the companies that make the drugs, were deliberately delaying the release of the trial results “to hide something.?

The companies did not release the preliminary results of the trial, called Enhance, until January, almost two years after the trial was finished. When they were finally released, the trial’s results showed that the drugs, Vytorin and Zetia, did not work to reduce plaque in arteries. The results led a panel of cardiologists to recommend on Sunday that the drugs be used only as a last resort. ... The drugs are used to lower cholesterol and are among the most widely prescribed medicines in the United States, with sales of $5 billion last year. Shares of Merck and Schering plunged on Monday."

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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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February 4, 2008

When Drug Trials Go Wrong

Don't miss an important story from the Wall Street Journal last week about things going wrong in clinical trials, questions about informed consent forms, and about liability - especially as companies speed up the pace of trials.

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January 15, 2008

Ethical news director quits over hospital deal for fake TV health news

Although I said I was on a blog break until January 22 because I'm on vacation and should be out on the beach, when I read about this, I had to share it with those who may not have seen it.

An Eau Claire, Wisconsin newspaper reports the following:

"One year after being hired as WEAU TV-13 news director, Glen Mabie has resigned because of a disagreement with station management regarding coverage of medical topics.

According to Mabie and other sources close to the situation, station management attempted in recent weeks to negotiate a deal with Sacred Heart Hospital in which TV-13 would run medical stories featuring personnel from that hospital and its affiliates but not employees of other Chippewa Valley hospitals or clinics.

That didn't sit well with Mabie, who said an exclusive deal with Sacred Heart posed an obvious conflict of interest that called the newsroom's objectivity into question. Mabie said he was unsure whether the hospital would pay TV-13 as part of the agreement.

"My problem with this is it was going to dictate newsroom content," said Mabie, whose last day at TV-13 was Friday. "I told myself that I could not with a clear conscience go into that newsroom and tell the staff that this was a good thing."

If this went down as the newspaper reports, my hat goes off to Glen Mabie, the only news executive I've heard of in this country who spoke up and stood up against this very common practice. Health news is being sold to the highest bidder in many communities.

In the past, I've blogged about this practice and how widespread it is. How and why the Radio-Television News Directors Association - whose code of ethics clearly addresses such practices - fails to address this directly and openly should be a source of embarrassment to that organization.

And to all other station managers and news executives who - unlike Glen Mabie in little Eau Claire, Wisconsin - have looked the other way and allowed this practice to continue, shame on you. Viewers of these stations should turn away from your "product" and never come back.

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January 2, 2008

Guinea-pigging

Bioethicist Carl Elliott has a terrific and disturbing article in The New Yorker (subscription required for full text) about the demand for healthy human subjects for drug safety trials. Elliott quotes an attorney representing volunteers injured at commercial testing sites: "This is something the poor do so that the rich can get better drugs."

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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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November 7, 2007

Kickbacks to orthopedic surgeons

From Integrity in Science Watch, a publication of the Center for Science in the Public Interest:

"Nearly 50 orthopedic surgeons, many affiliated with the nation’s top teaching hospitals, each earned over $1 million a year in consulting contracts and royalties from the five companies that make artificial knees and hips. The payment disclosures were posted on the companies’ websites last week as part of a $311 million anti-kickback settlement between four of the firms and the U.S. attorney for northern New Jersey. The complaint had accused the companies of using consulting contracts as an illegal kickback scheme to get surgeons to use a particular company’s artificial joints. ...

With seniors accounting for nearly 70 percent of the knee and hip replacement market, Medicare spent $16 billion on the procedures last year. A typical knee replacement costs $33,000, according to Medicare records. A spokesman for Christopher J. Christie, the U.S. attorney in Newark, said the investigation into the alleged kickback scheme is ongoing."

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September 29, 2007

$500 million settlement doesn't wash away drug company sins

The Boston Globe reports:

"Bristol-Myers Squibb and a subsidiary have agreed to pay more than $515 million to settle civil suits over fraudulent drug marketing and pricing schemes, including illegally promoting an anti-psychotic drug to children and the elderly, US Attorney Michael J. Sullivan said yesterday. ...

The agreement says Bristol-Myers Squibb gave kickbacks to physicians and healthcare providers from 2000 through mid-2003 to get them to prescribe the company's drugs. The kickbacks came in several forms, including consulting fees and trips to luxury resorts.

"Patients are entitled to unbiased decision-making from their physicians and should not have to worry that financial inducements or lavish entertainment have influenced their physicians' prescribing choices," Sullivan said. ...

Bristol-Myers Squibb participated in pricing schemes, including one involving its anti-depressant drug Serzone, that defrauded the Medicaid program, prosecutors said.

Bristol-Myers Squibb and Apothecon also inflated prices for a wide assortment of cancer-fighting and generic drugs, deceiving federal healthcare programs that established reimbursement rates based on those prices, prosecutors said. ...

Dr. Jerome Kassirer, a professor at Tufts University School of Medicine and outspoken critic of drug companies, is skeptical.

"A lot of these companies, when they get sued for a few million dollars, they just consider it loose change," he said. "I haven't seen any let-up in what they're doing. Most of the time, when they're caught, they'll often say, 'It was a renegade, someone who wasn't following the instructions. Our policy says we shouldn't do that.' "


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September 28, 2007

Avandia execs planned punishment for researcher's negative findings

A story in the September 29 issue of New Scientist magazine reports:

When the US Congress examined the controversy over the diabetes drug Avandia back in June, things got embarrassing for GlaxoSmithKline. A researcher who raised safety concerns in 1999, although he later withdrew them, was questioned about attempts by the company to silence him – a charge GSK denied. Now it has emerged that conversations about how to deal with the critic took place at the highest levels. Internal emails presented to the Senate this month show that several executives, including CEO Jean-Pierre Garnier, knew of plans to put pressure on John Buse, a diabetes researcher at the University of North Carolina at Chapel Hill (UNC). One email, entitled “Avandia Renegade?, was sent in June 1999 by William Claypool, a senior vice president at what was then called SmithKline Beecham, to Tachi Yamada, then chairman of research and development. It accuses Buse of misrepresenting safety data. Claypool suggests warning Buse not to repeat the claims, with the “punishment? being that “we would complain up his academic line? and to the bodies that gave Buse accreditation for teaching. Yamada’s reply, sent the same day, was copied to Garnier. In it, Yamada discusses the possibility of approaching the chairman of Buse’s department and of suing Buse for “knowingly defaming our product?.
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June 8, 2007

Avandia critic says drugmaker tried to shut him up

The Washington Post reports on how North Carolina researcher John Buse, the incoming president of the American Diabetes Association, says he was intimidated by the maker of Avandia in 1999 when he began questioning the drug's safety. Excerpt:

"Buse said company officials considered his actions "scurrilous" and implied that he might be held accountable for a $4 billion drop in the drug firm's stock.

"I was characterized as a liar and I was characterized as being for sale," Buse told the House Oversight and Government Reform Committee, which released a letter that he wrote in response.

"Please call off the dogs. I cannot remain civilized much longer under this kind of heat," Buse wrote.

Moncef Slaoui of GlaxoSmithKline, the company's new name after a merger, expressed regret about the episode, attributing it to the "passion" of officials at the time."

Passionate, indeed. But nothing stirs pharma's passion like threats to the bottom line.

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March 30, 2007

The Limitations of Drug Testing in Animals

A Wall Street Journal story today looks at an important question in science, in policy-making, and in journalism: "What do the results of animal studies really tell us about humans? That question still puzzles researchers even though guinea pigs, lab rats and their brethren have long been part of experiments."

Two examples from the story:

Many times, however, subtle results in animals are unclear and scientists just don't know what to make of them. In the case of the new Novartis drug Galvus, James Shannon, the company's global head of pharmaceutical development, told investors that Novartis researchers "do not understand -- do not know -- the mechanism of the skin findings" in monkeys. They do know that "humans appear to react to Galvus in a very different way."

Another example of the confusing disparities that can arise in testing is the case of the popular sleep drug Lunesta. It won FDA approval despite the fact that tumors appeared when rats and mice took huge doses of a closely related chemical cousin of the medication. Some FDA reviewers were concerned enough initially to recommend rejection of Lunesta. After further analyses, however, agency officials concluded the data from human testing didn't suggest a signal for cancer in people. But you won't see the issue highlighted in the company's ubiquitous green-moth commercials for the drug.

Journalists who report on preliminary findings from animal research without strongly emphasizing the inherent weaknesses in trying to interpret such findings are not serving the public.

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February 26, 2007

Why so much medical research is rot

The headline above is the headline of a piece in The Economist, in the February 22 edition. Excerpts:

"People born under the astrological sign of Leo are 15% more likely to be admitted to hospital with gastric bleeding than those born under the other 11 signs. Sagittarians are 38% more likely than others to land up there because of a broken arm. Those are the conclusions that many medical researchers would be forced to make from a set of data presented to the American Association for the Advancement of Science by Peter Austin of the Institute for Clinical Evaluative Sciences in Toronto. At least, they would be forced to draw them if they applied the lax statistical methods of their own work to the records of hospital admissions in Ontario, Canada, used by Dr Austin.

Dr Austin, of course, does not draw those conclusions. His point was to shock medical researchers into using better statistics, because the ones they routinely employ today run the risk of identifying relationships when, in fact, there are none. He also wanted to explain why so many health claims that look important when they are first made are not substantiated in later studies.

The confusion arises because each result is tested separately to see how likely, in statistical terms, it was to have happened by chance. If that likelihood is below a certain threshold, typically 5%, then the convention is that an effect is “real?. And that is fine if only one hypothesis is being tested. But if, say, 20 are being tested at the same time, then on average one of them will be accepted as provisionally true, even though it is not. ...

So, the next time a newspaper headline declares that something is bad for you, read the small print. If the scientists used the wrong statistical method, you may do just as well believing your horoscope."

On HealthNewsReview.org, one of the 10 criteria we apply to our review of news stories is whether the story adequately explains the quality of the evidence. Journalists may feel this is too "academic" - too detailed for most readers. If what one is reporting is likely to be flawed, we think it is an excellent criterion to apply.

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February 1, 2007

Think of Baycol when you hear new drug hype

Whenever I think about premature enthusiasm for new drugs, when I hear doctors talking about putting statins in the water supply, when I hear news reports that a drug is safe -- I think of Baycol. The statin drug was approved about ten years ago, but pulled from the market about five years ago after being linked to 31 deaths.

The Houston Business Journal now reports:

"Bayer Corp. will pay $8 million to 30 states, including $200,000 to Texas, as part of a settlement requiring the company to fully disclose when drugs pose risks for patients with specific health conditions.

According to the settlement, Bayer failed to adequately warn physicians, pharmacies and patients of clinical studies revealing serious consequences of taking Baycol, a cholesterol-lowering drug. The company pulled the drug from the market in August 2001 due to its muscle-weakening side effects.

The terms also extend to the disclosure of clinical studies involving other Bayer drugs with possibly harmful side effects. ...

The terms of the judgment require that Bayer register its clinical studies and, upon the completion of each study, post the results on the Internet. The marketing, sale and promotion of Bayer's pharmaceutical and biological products must comply with the law and cannot include false or misleading claims."

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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 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 24, 2007

How common is medical journal ghostwriting?

A study in PLoS Medicine concludes that ghost authorship in industry-initiated trials is very common. The authors write that "Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability."

That's mild. It may be a sign that positive news is being overemphasized and negative news is being squelched. And for journalists who live off the latest tidbit out of a medical journal, and for consumers who rely on news outlets for their health/medical/science news and information, this raises an important new and huge red flag.

The authors looked at 44 industry-sponsored drug trials in Denmark in the 1990s.

"We found evidence of ghost authorship for 33 trials (75%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors."

Why would ghostwriters not be named? The authors write: "This might happen because the study 'looks' more credible if the true authors (for example, company employees or freelance medical writers) are not revealed. This practice might hide competing interests that readers should be aware of, and has therefore been condemned by academics, groups of editors, and some pharmaceutical companies."

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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 22, 2006

Egregious spinning of lung cancer screening news

In the latest edition of The Cancer Letter (Nov. 22, 2006, Vol. 32 No. 42), Editor & Publisher Kirsten Boyd Goldberg and Editor Paul Goldberg, publish an extremely important and troubling followup to the lung cancer CT scanning study published in the New England Journal of Medicine several weeks ago. They obtained documents distributed by the the International Early Lung Cancer Action Program – or I-ELCAP - the organization that conducted the study published in the NEJM. The documents give “talking points? to be used in media interviews about the study. Physicians who put patients on the study were urged to repeatedly use the word “compelling? to describe the results being published, refrain from mentioning ongoing randomized trials, and urge people to get screened. The “talking points? also urged interviewees to avoid using the terms “observational or noncomparative? to describe the design of the trial – even though those are accurate terms for the study design, seen as a limitation by some critics.

In the article, ethicist Heidi Malm says “Why instruct other researchers not to state factual claims? This limits informed consent by suggesting that this kind of study has the same merit as other studies. [Claudia Henschke, I-ELCAP principal investigator and lead author of the study] is blocking the terms that would make it clear that it isn’t the same kind of study, so people might just assume that it has the same evidentiary quality as a randomized clinical trial. This limits informed consent from the public. They are assuming this has been shown to be effective in terms of saving lives and not just in terms of finding new cancers. It feeds into the misassumption by the public that finding more cancers is the same as saving more lives and that’s what we need the randomized trial to show.?

I am also quoted in the article: “I consider myself well-informed on the latest methods of ‘managing the media’ by different sources in the dissemination of health, medical and science information. I consider myself quite skeptical. Yet I am shocked by what is written in these I-ELCAP ‘soundbites.’ The admonition to ‘stay on the high ground’ begs the question of ‘what is the low ground?’ To me, the low ground is the deception that is recommended in these talking points. The advice is to avoid discussing the trial design. Here are scientists urging each other to mislead journalists into doing an inferior job. The observational nature of the trial is critical to consumer understanding. But the I-ELCAP PR machine advises spokespersons to run from the truth.?

A copy of the "talking points" spin document is included in The Cancer Letter article. While the Letter is a subscription-only publication, Editor & Publisher Kirsten Boyd Goldberg says she will send a free copy to anyone who writes to her at: kirsten@cancerletter.com.

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November 11, 2006

Trust in medicine; docs can't be pharma lapdogs

A Georgetown professor warns in this week's BMJ that doctors can not be lapdogs to drug companies.

Her warning comes after she addressed a conference about the influence of the drug industry on continuing medical education. And after several companies withdrew or threatened to withdraw their support for future conferences because of what she said.

Professor Adriane Fugh-Berman’s talk covered the costs of drugs, the costs of promoting drugs to doctors, the salaries of drug representatives, and the funding of continuing medical education. She also covered psychological profiling and monitoring of physicians, including prescription tracking.

She writes, “Drug representatives are paid to be nice to us, as long as we cooperate, sustaining market share of targeted drugs, and limiting our continuing medical education lectures to messages that increase drug sales. ...If we remain dependent on pharmaceutical companies for sponsoring continuing medical education, then these courses will remain under the control of the drug industry. This control is not contractual, but it is enforced through psychological manipulation. ... As a last resort, we physicians could actually pay for our continuing education, as do lawyers, accountants, business people and aerobics teachers, to mention a few." ...Medicine must shed its docility and the corporate leash. Let us not be a lapdog to the pharmaceutical industry. Rather than sitting contentedly in our master’s lap, let us turn around and bite something tender. Freedom calls.?

In the same issue of BMJ, editor Fiona Godlee writes, "Trust is at stake in every decision doctors make, and unchecked clinical enthusiasm can threaten professional integrity. Above all, beware of optimism bias... Two papers in the BMJ suggest that this "unwarranted belief in the value of interventions" has been at work with statins."

Optimism bias is fed by pharma influence. Thanks, BMJ, for publishing these important observations.

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July 27, 2006

Another new conflict-of-interest issue in a medical journal

There may soon be a new daily column or website dedicated to the medical journal/research conflict-of-interest du jour.

The Boston Globe this week has a must-read article on a new angle.

A bunch of physicians who proposed routine screening of virtually every middle-aged person for heart disease using expensive scanning technology say they were frustrated waiting for support from the American Heart Association or the American Journal of Cardiology. The Globe says, "Usually, such a seismic shift in medical practice -- it would affect 50 million US adults and easily cost $25 billion or more -- emerges from a government agency or a major professional organization."

But this handful of physicians proposed a supplement in the American Journal of Cardiology. The journal made them find the funding. The Globe reports: "To raise the money, the physicians sent letters of appeal to a half-dozen major pharmaceutical companies, receiving $55,800 from the maker of the blockbuster cholesterol-lowering drug Lipitor, Pfizer Inc., which might benefit if more people are diagnosed with heart disease.

'The whole thing sounds like a conflicted mess, from the recommendations that they're making to the issue of how these journal supplements work,' said Dr. Jerome P. Kassirer, top editor of The New England Journal of Medicine through most of the 1990s and an outspoken critic of the intrusion of financial interests into the scientific process."

The article goes on to question the evidence to support the aggressive screening recommendations, and the varying policies of medical journals for such "pay to play" supplements, which do not undergo the same review as studies published in the journals.

It's a mess, and the Globe did a terrific job in shining a light on it.

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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 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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March 10, 2006

Faith in 'Miracle Cures' Is Fading in South Korea

Good story under this headline in the Los Angeles Times. Another cautionary tale of false hope, premature PR hype, and people who get hurt as a result.

The story begins: "When Hwang Mi Soon rose from her wheelchair and shuffled forward with the aid of a metal walker, her small steps were trumpeted around the world. 'Stem-Cell Gal's Miracle Steps,' crowed the New York Post in November 2004, while a New Zealand newspaper proclaimed, 'Miracle Cure for Paralysis.' The breathless pronouncements were accompanied by photographs of the 37-year-old South Korean woman who, just as in the cliche, was smiling through her tears.

Today there are only the tears.

Hwang is back in the wheelchair, where she has largely been since falling off a bridge as a teenager. She said the purported miracle treatment — which entailed injecting umbilical stem cells into her damaged spine — had only fleeting benefits that wore off after a few weeks. A second procedure in March 2005 caused an infection and left her in constant pain.

'I was like an animal they used for testing,' a bitter Hwang said."

One neurosurgeon says in the story: "The problem in Korea is that these therapeutic tests were conducted as much for public relations as for the patients," Jeong said. "There should have been more clinical testing on animals before they tried these procedures on people."

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February 28, 2006

In the guts of Guidant

More about money in health care.

The New York Times reports: "As the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its heart devices, the company's public message was upbeat and insistent: concerns about the safety of its products were overblown, it said, and perhaps even irresponsible. But newly released documents show that, inside Guidant, executives were struggling to contain a mounting crisis. The records illustrate how a series of miscalculations by Guidant, like its misreading of doctors' tolerance for being kept in the dark and its initial decision not to recall the devices, put the company on the defensive. "

According to the Times, in 2004, Guidant's heart device division accounted for about half of Guidant's $3.8 billion in sales. Defibrillators, which cost up to $35,000 each, have a profit margin of about 75 percent.

One physician says in the story, "I will not work with a company that put profit and image in front of good patient care and honesty in device manufacturing."

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December 13, 2005

Ghostwriting in medical journals

The Wall Street Journal today has an excellent, although troubling look at ghostwriting. That is, researchers who do the work don't actually write the research results in papers submitted to journals.

Sometimes the "ghostwriting" is not disclosed. Oftentimes the ghostwriter is hired by a drug company whose product is the subject of the research.

One journal editor tells the story of a paper that was submitted but the "track changes" function of Word was still in place. It showed that the "author" really didn't write the article. And a telltale note was in the text: "Marketing approval required."

This is an ethical issue that journals and the scientific community must deal with.

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