What’s Behind the Growing Rate of Scientific Retractions?

Alison Bass

First posted 8/10/11 on Alison Bass

The retraction of studies in medical and scientific journals has surged in the last decade, according to separate analyses done by the Wall Street Journal and Retraction Watch.

In its page-one article today, the Journal noted that while just 22 retraction notices appeared in 2001, there were 139 in 2006, 339 last year and 210 so far this year. Retraction Watch, in a blog celebrating its one-year anniversary, said it has recorded 200 retractions over the last 12 months, compared to an annual average of about 80 over the previous 10 years.

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With Big Pharma on Campus, Who Will Look After the Public Interest?

Alison Bass

First posted 8/3/11 on Alison Bass

Medicare and social services for vulnerable Americans are not the only programs on the chopping block with Washington’s deal to raise the debt ceiling and cut trillions of dollars in government spending. Looming ahead may be deep cuts in funding for medical and science research, and that raises the specter of growing collaboration between academic centers and industry, including pharmaceutical and medical device companies.

Even before the debt deal was reached, partnerships between Big Pharma and universities have been on the rise, according to an article in the current issue of Chronicle of Higher Education. The article, Big Pharma Finds a Home on Campus, details this growing collaboration and the “many new ethical and practice questions” it raises, including the increasing potential for conflicts of interest.

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Tougher NIH Rules About Financial Conflicts in Danger of Being Watered Down

Alison Bass

First posted 7/20/11 on Alison Bass

I realize this is the dead of summer and every journalist who isn’t on vacation is captivated by the Murdoch phone-hacking scandal. But while everyone is looking the other way, the National Institute of Health’s proposed new rules about the disclosure of financial conflicts of interest may be watered down.

The sticking point, according to the Project on Government Oversight (POGO), is a proposed rule that would require government-funded researchers to publicly disclose potential conflicts of interest to consumers. POGO officials say that the Office of Management and Budget (OMB), which has been reviewing the proposed changes for months, may weaken or eliminate the public disclosure requirement due to pressure from industry and university officials. In a letter to OMB July 11, POGO’s executive director Danielle Brian and staff scientist Ned Feder called on the OMB to make sure that requirement remains in the new guidelines.

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The Real Reason the Biotech Industry Opposed Medicare’s Independent Payment Advisory Board

Alison Bass

First published 6/27/11 on Alison Bass

A page-one story in The Boston Globe today spotlights the Massachusetts biotech industry’s effort to block a key piece of President Obama’s health care overhaul: the creation of an independent payment advisory board (IPAB) that would make recommendations on how to trim wasteful and counterproductive Medicare spending.

The presidentially appointed board, to be comprised of representatives from hospitals, physicians, patients, drug and device companies and other health care constituencies, is supposed to recommend program changes that will hold Medicare spending increases to levels that are no greater than the pace of economic growth (GDP) plus one percent. As Merrill Goozner explains in gooznews, the board can recommend replacing fee-for-service with bundled payments or pay-for-performance schemes. It can penalize health care organizations for lousy care and give them incentives for higher quality care. Whatever the board recommends must be passed by Congress, which also has the option of substituting its own cost-cutting measures.
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Helen Mayberg and Conflict of Interest Transparency

Alison Bass

First published 5/17 on Alison Bass

A year ago, the Department of Health and Human Services proposed new rules governing the disclosure and handling of financial conflicts of interest by medical researchers who receive federal funding. The more stringent rules were prompted by Congressional findings that prominent NIH-funded researchers had failed to disclose significant consulting and other income, violating the agency’s own regulations. The new rules would, among other things, require universities to post on a publicly available website information describing the specific financial conflict of interests of their federally funded researchers, according to Sheldon Krimsky, the Tufts University ethicist who wrote about the new rules in an article for Ethics in Biology, Engineering & Medicine last year.

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Serious Flaws and Conflicts Undermine Largest Anti-Depressant Study

Allison Bass

First published 4/25/11 on Alison Bass

In 2006, researchers first published results from a $35 million NIMH-funded study of antidepressants known as STAR*D, claiming it proved the effectiveness of second-generation antidepressants used alone and in combination with each other. The NIMH chimed in with press releases extolling “new strategies” that help depressed patients become symptom-free, and the findings became the basis for American Psychiatric Association’s guidelines calling for the open-ended use of antidepressants in treating depression.
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Let’s Fix Medicaid’s Perverse Financial Incentives Before Hacking Its Budget

Alison Bass

First published 4/15/11 on Alison Bass

Medicaid and Medicare are in the news of late, as Congressional Republicans spar with President Obama and the Democrats on how best to rein in the ballooning costs of these entitlement programs, which make up a growing share of federal and state budgets. But what few policy makers seem to be talking about — at least in public — are the perverse financial incentives built into the system that allow the companies who manage Medicaid contracts on a statewide basis to make profits at the expense of quality health care for Medicaid recipients. As a result of these perverse incentives, many Medicaid patients, particularly those being treated for mental health problems, are either terribly under-served or in some cases, badly over-treated. The upshot, in many cases, is poorer health outcomes and higher Medicaid costs.

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A Tale of Censorship and Secrecy Starring the American Psychiatric Association

Alison Bass

First published 4/4/11 on Alison Bass

Psychiatry is supposed to be all about disclosure, disclosing the dark secrets of one’s past to a professional in an effort to heal or, at the very least, figure out why one is in such psychic pain. But given the recent actions of the American Psychiatric Association, the largest trade group for psychiatrists in the U.S., one might get the impression that the profession is really all about censorship and obfuscation.

Remember when the Project on Government Oversight (POGO), as part of an effort to get the NIH to crack down on ghostwriting, released documents showing that a psychopharmacology handbook for primary care doctors, authored by then psychiatry kingpins Charles Nemeroff and Alan Schatzberg, had actually been ghost-written by a company hired by GlaxoSmithKline, the maker of the blockbuster antidepressant, Paxil? The New York Times broke the story last fall, relying on internal Glaxo documents obtained in the course of a lawsuit against the drug giant, and a number of other journalists, including myself, blogged about it — see here. The documents showed that Glaxo hired Scientific Therapeutics Information (STI) to prepare a draft of the textbook with the understanding that Glaxo could review the initial drafts before publication. The handbook itself, which was published in 1999 by the APA, essentially promoted Paxil, among other drugs, as a safe and effective treatment for anxiety and depression.

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The Corrosive Influence of Industry Money on Cardiology Practice Guidelines

Alison Bass

First published 3/28/11 on Alison Bass

In a finding that may stun heart patients but surprise few others, researchers have found that more than half of the doctors who wrote key clinical practice guidelines in cardiology had financial ties to medical device and drug companies that stood to benefit from those guidelines. The study, published today in the Archives of Internal Medicine, raises serious questions about the reliability of such clinical guidelines in treating heart disease.

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Are We Seeing a Concerted Drug Industry Campaign Against the FDA?

ALISON BASS

First published 2/10/11 on Alison Bass’ blog.

There must be something in the air. Either that, or the drug and medical device industry has embarked on a concerted campaign to improve its tattered public image and bully the FDA into backing down from recent efforts to ensure that unsafe drugs and medical devices are kept from the market.

First appeared an op-ed piece in The Boston Globe early this week complaining that the average number of new drugs approved by the FDA since 2005 has dropped 33 percent and urging the FDA to once again speed up the process. The op-ed was penned by none other than Christoph Westphal, a biotech entrepreneur who made a mint when he sold his startup, Sirius, to GlaxoSmithKline in 2008 for a whopping $720 million.

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