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Call for NIH to fund research on ethics, conflicts of interest

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I was among 100 researchers, clinicians and ethicists who this week signed and sent a letter (pdf file) to the National Institutes of Health asking them to fund research on medical ethics, conflicts of interest and industry influence on prescribing behavior.

The effort was led by Dr. Adriane Fugh-Berman, who leads the PharmedOut (http://pharmedout.org) project at Georgetown University Medical Center to educate physicians about industry influence on prescribing.

The letter states:

"Between bench and bedside lies a path treacherous with ethical quandaries. NIH is the best place to launch and support a scientifically rigorous inquiry into the state of research ethics, industry-academic relationships, and the effect of these relationships on human health. There is currently no identifiable mechanism through which NIH would fund this research.


Your leadership regarding the importance of this issue as one the NIH needs to direct resources towards is essential. We hope to discuss these issues in a face-to-face meeting."

An article on TheScientist.com contains more details.

Osteopaths try to buy journalists' attention with iTunes gift cards

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Scott Hensley reports on another low point in health industry marketing efforts.

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Investigative report on patient safety issues in drug study

See the Huffington Post investigative fund piece by Jeanne Lenzer and Shannon Brownlee, "Government Orders Columbia to Tell Patients 'True Nature' of Drug Study: Officials Say Research May Have Caused Harm to People Who Had Heart Surgery." Excerpts:

"....two-year medical study at Columbia that government regulators now say was carried out with ethical and regulatory mistakes and may have caused harm to some patients. The study was testing a commonly used intravenous surgical fluid that previous studies had shown could cause hemorrhaging at high doses. At least two patients in the study died shortly after receiving the fluid and more than two dozen others required transfusions, according to documents submitted to the federal government by the hospital and obtained by the Huffington Post Investigative Fund. ...


The issues raised by the Columbia study, which was indirectly funded by a pharmaceutical company, reflect the ongoing national debate over flaws in the system designed to protect people who participate in medical research. The federal oversight office has cited more than 40 hospitals and academic medical centers in the past two decades for falling short. The Columbia case stands out for the bitter controversy it has engendered for years inside the hospital, the courts and the federal government - reported here for the first time - and for the hospital's failure to contact patients even after federal investigators recommended it do so in 2003."

A ho-hum week for Pharma

1. Pfizer gets hit with a record $2.3. fine for off-label marketing of drugs.

2. Forest Laboratories' marketing shenanigans for its antidepressant Lexapro. As the New York Times reported:

"A document quietly made public recently by the Senate's Special Committee on Aging demonstrates just how Forest managed to turn a medicinal afterthought into a best seller. ... (the document makes) clear that one of the principal means by which Forest hoped to persuade psychiatrists, primary care doctors and other medical specialists to prescribe Lexapro was by finding many ways to put money into doctors' pockets and food into their mouths."

3. Schering -Plough motion to dismiss is denied - as reported by ShearlingsPlowed.com:

(The judge has) gone out of his way to signal that he thinks the plaintiffs have mustered-up a pretty good set of claims:

. . . .Plaintiffs, purchasers of Schering-Plough Corp. ("Schering") securities during the period July 24, 2006 to March 28, 2008, allege that Schering, five members of its senior management, eleven of its current directors and one former director, and eighteen underwriters that participated in Schering's August 2007 public stock offering (the "Offering") are liable in damages for unlawful misstatements and omissions made in connection with the Offering relating to the cholesterol drug Vytorin and the ENHANCE clinical study. . . .

Merck CEO wanted poster.jpg4. Merck price-gouging its HIV drug? ShearlingsPlowed.com reports this one, too:

AIDS Healthcare Foundation (AHF) today unveiled its latest advocacy campaign challenging Merck and Co. Pharmaceuticals over the steep price of its key HIV/AIDS drug, Isentress (raltegravir). The first phase of the public awareness campaign includes a postcard mailer, scheduled to arrive this week in the mailboxes of residents of Whitehouse Station, New Jersey, where Merck is headquartered. The front of the postcard features a mock "Wanted" poster with an artist rendering of Merck CEO Richard T. Clark pictured beneath the headline: "WANTED: Criminal AIDS Drug Pricing."


5. Merck in court over Fosamax problems, as reported by the NY Times:

Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug from Merck that has been taken by millions of women to offset the bone loss associated with menopause.


It is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop a rare problem called osteonecrosis of the jaw.

For people who cover the drug industry or follow the drug industry closely, this is probably not an extraordinary week.

Which is an extraordinary observation in itself.

What's that about market solutions to health care reform?

Dr. Jon Abramson, a pharmaceutical safety and ethics expert at the Harvard Medical School. "Unless health care reform can address misrepresentations, withholding science and control claims made to consumers, Americans will continue to pay too much for health care that is not as effective and is expensive." (ABCNews.com)

"It's hard to do what's right when everyone else around you is following management sales directive," Pfizer whistleblower John Kopchinski told the BBC's World Today.

"In the Army I was expected to protect people at all costs," Kopchinski said in a statement. "At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives." (Reuters)

"There's so much money in selling pills, that there's a tremendous temptation to cheat," said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports. "There's a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat,'' he said. "This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship." (Star-Ledger)

"What you see here is a company which essentially had a culture of corruption," said Patrick Burns, a spokesman for Taxpayers Against Fraud, a U.S. nonprofit organization that helps connect whistleblowers with attorneys on False Claims Act cases. (Reuters)

Using "continuing medical education" to sell drugs

How (im)pure is continuing medical education and the marketing of drugs to physicians?

See the New York Times piece and Dan Carlat's blog perspective on the marketing of the antidepressant Lexapro.

A potential "problem of enormous proportions" with the medical literature

Larry Husten, who's much quicker than I am, writes on Cardiobrief.org:

Mandatory registration of clinical trials was supposed to prevent some troubling abuses of the research system. Two new studies published today suggest that many of these abuses continue.

And Larry got Yale's Harlan Krumholz to comment on the significance of both papers for CardioBrief:

These papers, in tandem, highlight the shortcomings of the national registry of randomized trials. Much important information is missing from the voluntary registry, wrong information is included in the registry, and many studies remain unpublished even years after they are completed. The findings raise concerns about the quality and completeness of the medical literature.


These studies reveal a major flaw in the medical literature. These articles are a clarion call to action: if we cannot trust the literature - that it is complete and accurate - at least for trials important enough to be registered - then we have a problem of enormous proportions.


While many news organizations will undoubtedly report on positive news for the drugs known as aromatase inhibitors for breast cancer because of a study in this week's New England Journal of Medicine, few will probably pick up on a letter to the editor of the Annals of Oncology raising questions about aromatase inhibitor recommendations.

Päivi Hietanen of the Finnish Medical Journal wrote the letter. Hietanen asks if an expert panel provided an unbiased opinion about aromatase inhibitors in the management of women with early breast cancer.

Start lining up the awards for the series on conflict of interest published by the Milwaukee Journal-Sentinel this year.

Excerpts of the latest:

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"As fears were growing about the link between hormone therapy and breast cancer, a drug company paid the University of Wisconsin to sponsor ghostwritten medical education articles that downplayed the risks, records obtained by the Journal Sentinel show.


The five articles were funded by Wyeth, the company that made the top-selling hormone therapy products. The articles, published in 2001, appeared under the names of doctors who specialized in diseases common to menopausal women, but actually were written by professional writers paid by the company. badger.jpg

The articles came shortly before a long-term $1.5 million arrangement between Wyeth and UW to educate doctors and patients around the country about hormone therapy. The initiative promoted the benefits and softened the risks of drugs that produced sales of more than $1 billion a year."

Batmanannual14.pngThe article also showed two faces of health care on this issue. Excerpt:

"The company's ultimate goal is to sell more drugs, said Steven Miles, a physician and professor at the Center for Bioethics at the University of Minnesota Medical School.


"These ghostwritten articles are advertising masquerading as scientific reviews," he said. "It's dishonest."

One of the listed authors, Leon Speroff, then a professor of obstetrics and gynecology at Oregon Health Sciences University...said the practice of ghostwriting remains commonplace, and he defended it.

"There is nothing dishonest about it," he said.

He laughed at the idea that someone might be offended by the lack of transparency.

"If you don't like the way it works, that's your business," Speroff said."

The Association of Bioethics Program Directors - with members in 60 academic bioethics programs posted "a clear message about some myths that challenge the ethics of reform proposals."

New Scientist reports:

Lightning never strikes again in the same place? Tell that to the University of Minnesota in Minneapolis, which has launched yet another inquiry into research at its Stem Cell Institute after New Scientist raised further concerns about papers that seem to contain duplicated and manipulated images.

You can read the New Scientist article for more details. But note the ending:

Other stem cell biologists are disturbed that so many problems have been found in papers from a single institution. "It's pretty discouraging," says Arnold Kriegstein of the University of California, San Francisco. Given the pressure on scientists in such competitive fields, he wonders what might emerge at other research centres if their publications were subjected to similarly close scrutiny. "It raises serious issues about how widespread this could be," he says.

HRT ghostwriting - steroids on steroids

I'm late on this one and it's been widely covered. But in case you missed it, I like Dan Carlat's blog posting
on the New York Times' revelation that:

Wyeth Pharmaceuticals engaged a medical writing company to produce 26 articles pushing Premarin as Hormone Replacement Therapy (HRT) in women from 1998-2005. The articles were outlined and written by writers employed by Design Write, and then were sent to top academics in the Ob/Gyn field, who reviewed them, rubber stamped them with occasionally minor edits, and submitted them to journals under their names. In no case was Wyeth's involvement in funding the articles disclosed.


Carlat continues:

In this case, since Premarin is a steroid, Wyeth put its own steroids on steroids. As with baseball players on steroids, when companies pour marketing money into ghostwriting campaigns, they change the rules of the academic game. The playing field is no longer level; the drug company's version of the truth gains the upper hand. Sometimes, their truth really is the truth, but sometimes it's a carefully crafted lie. Sorting it out is difficult even for physicians who specialize in the area being written about. It's essentially impossible for the average generalist physician, to say nothing of patients who did not have the advantage of attending medical school.


...Wyeth's spokesman said that "the articles on hormone therapy were scientifically sound and subjected to rigorous review by outside experts on behalf of the medical journals that published them."

Actually, the proper collective response from all of these participants should have been: "We sincerely apologize for having deceived the medical community by engaging in ghostwriting without disclosure. We have contributed to the erosion of the public's trust in medicine, and we regret it."

When I served on the University of Minnesota medical school task force making recommendations for changes in the school's conflict of interest policy, I was the one who recommended addressing ghostwriting. We'll see if it ends up in the final version.

The St. Paul Pioneer Press reports:

It's nice work if you can get it: $1,750 to talk shop at dinner; $42 for making a five-minute phone call; $125 to spend 15 minutes on some e-mail.


When your pay rate is $500 an hour, the money adds up.

Welcome to the world of Dr. David Polly, the University of Minnesota spine surgeon who received nearly $1.2 million in consulting fees from medical device giant Medtronic over a five-year period.

Details of Polly's billing records were released this week by Sen. Charles Grassley, R-Iowa, as an attachment to a letter to University of Minnesota President Robert Bruininks. The letter raised questions about how the U polices conflicts of interest among doctors.

And on Thursday, Fridley-based Medtronic -- the world's largest maker of products used in spine surgery -- said it was asking some questions, too.

"We are investigating specific charges for which Dr. Polly billed us and determining whether or not they fit our standards and policies, and if newly enhanced standards are required," spokesman Steve Cragle said in a prepared statement.

... Dr. Charles Rosen, a spine surgeon in California who leads a medical ethics group, said he was among those surprised by the details.

"I've not seen anybody bill the way he did," said Rosen, of the University of California-Irvine, who acknowledged that he doesn't do paid consulting work with the device industry.

"In my opinion, it sounds more like an investment banker," he said of the detailed billing. "It doesn't sound like someone in medicine."

From invoices submitted to Medtronic by Dr. Polly:


# Download CDs from meeting, 15 minutes, $125

# Dinner meeting, 240 minutes, $2,000

# E-mail Medtronic employee, five minutes, $49.48

# Conference call, 90 minutes, $890.63

# Teach at scoliosis meeting, 330 minutes, $2,750

One of the most corrupt sectors of the nation's economy

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That's what Dr. Daniel Carlat calls industry-sponsored continuing medical education (CME) in his blog today. He advises:

Senator Herb Kohl (D-Wis) has just issued this press release announcing a hearing entitled "Medical Research and Education: Higher Learning or Higher Earning?" It will take place Wednesday, July 29, at 2 p.m., at 562 Dirksen Senate Office Building in Washington DC. You can view it live on the web by going to the Special Committee on Aging's website (http://aging.senate.gov/).

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