Thursday, July 28, 2011

Death, injuries, fraud, but no sanctions

Pharma companies conduct phony clinical trials with alarming regularity, but oversight bodies don't seem to care.  Why not?  Read about it in in the New York Times.

AstraZeneca says it has settled most of its Seroquel lawsuits

If current estimates hold, AstraZeneca will have paid $1.9 billion to defend and settle personal injury cases and government investigations over Seroquel.  That may sound like a lot, but it's far less than Eli Lilly paid for Zyprexa, and it represents only about five months of Seroquel sales.  Read about it at the New York Times Prescriptions blog.

Monday, July 25, 2011

Do psychoactive drugs increase rates of mental illness?

Robert Whitaker's recent book about pharma and mental illness, Anatomy of an Epidemic, has been getting renewed attention since Marcia Angell wrote about it in the New York Review of Books. You can listen to an interview with Whitaker on "The Takeaway."

Saturday, July 23, 2011

A major overhaul of research regulation?

The U.S. Department of Health and Human Services (HHS) has announced a plan to overhaul the guidelines that govern clinical research in the US.  The changes could be dramatic, but for now, the agency is seeking public comments.  Read about it here.

You say "drug whore" like it's a bad thing

Ah, the good old days. Remember when doctors could cash a drug industry check and feel proud of it? Back when nobody used the ugly phrase "drug whore" except angry reps who turned resentful when their doctors accepted money from a competitor? Now, of course, industry-funded doctors are being attacked from every direction -- the government, activists, university administrators, and especially the media. And all because they want to help people and make the world a better place.

That's apparently the way things look at ACRE, or the Association of Clinical Researchers and Educators, which held its annual meeting in New York on Friday. ACRE is a group devoted to preserving financial relationships between doctors and pharma. They believe they are under siege, and they are making plans to fight back. Read Duff Wilson's account on the NY Times "Prescriptions" blog.

Wednesday, July 20, 2011

"I will pay you $100 to write my strategic management paper"

Attention, Minnesota business school professors.  This ad was posted on Craigslist this morning: 

"I am taking a strategic management class and I need to write part of a paper as a group project. My part is due ASAP. I am simply unable to do it and am offering $100 to someone who can. It has to be about 25 pages. It should be easy money if you have ever taken a class on this before, and maybe easy if you haven't taken a class in this subject but are good at writing papers."  See the rest of the ad here.

Tuesday, July 19, 2011

ASBH Travel Grants for Early Career Scholars

Each year, the American Society for Bioethics and Humanities provides a select number of travel grants to early career scholars in order to help subsidize their travel to the annual meeting. Early Career Scholars are defined as students/scholars who are no more than  3 years beyond completing postgraduate work. The number of awards is limited, as is the amount of funding. The application deadline is August 26, 2011. The application form can be accessed here.

New Zealand Bioethics Conference: Call for Papers

No Country for Old Men (or Women): Increasing Pressures on the Health Care System
Salmond College, Dunedin, New Zealand 27-29 January 2012

Health care costs are steadily increasing partly due to new technologies. Should we fund comprehensive health care for all, only for those who meet certain criteria, perhaps related to age or lifestyle choices?

Call for Papers (by 14 October 2011)

The Bioethics Centre invites authors to submit abstracts for presentations at the New Zealand Bioethics Conference to be held at Salmond College, Dunedin, New Zealand 27-29 January 2012.

Read more here.

Monday, July 18, 2011

March of the Ass. Deans

“Generally speaking,a million-dollar president could be kidnapped by space aliens and it would be weeks or even months before his or her absence from campus was noticed.”  So writes Benjamin Ginsberg, a political scientist at John Hopkins, in his new book, The Fall of the Faculty: The Rise of the All-Administrative University and Why It Matters. Universities have been overtaken by assistant deans and other minor administrators whose primary mission is to justify their own existence. “Armies of staffers pose a threat by their very existence,” Ginsberg writes. “They may seem harmless enough at their tiresome meetings but if they fall into the wrong hands, deanlets can become instruments of administrative imperialism and academic destruction.”

Read the excellent interview with Ginsberg and article by Dan Berrett at Inside Higher Ed.

Sunday, July 17, 2011

No reps, no trinkets, no bribes

"A red circle with a line through it adorns the entrance to a psychiatric practice in Leonardtown, but it doesn’t refer to smoking or parking. Instead, the text inside reads “DRUG REPS” and warns medical salesmen not to darken the door."

Read about the Pharmed Out "No Drug Reps" campaign here.

Tuesday, July 12, 2011

How Big Pharma got Americans hooked on antipsychotics

"Has America become a nation of psychotics? You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux."  Read more on Al Jazeera.

The Chronicle reports on ghostwriting allegations at Penn

Here's the lead: A University of Pennsylvania psychiatry professor has accused his department chairman and four colleagues of publishing an article that was ghostwritten on behalf of a pharmaceutical company and made unsupported claims for one of its best-selling drugs.

The Ideal of Nature

"Going back at least to the writings of John Stuart Mill and Jean-Jacques Rousseau, people have argued for and against maintaining a state of nature. Is there an inherent virtue in leaving alone a naturally occurring condition, or does the human species thrive when we find ways to improve our circumstances? This volume probes whether "nature" and "the natural" are capable of guiding moral deliberations in policy making."

Read about the new book, edited by Greg Kaebnick, here.

POGO takes on Obama's bioethics commission

The Project on Government Oversight (POGO) has asked President Obama to remove Dr. Amy Gutmann, the President of the University of Pennsylvania, from her position as Chair of the Presidential Commission for the Study of Bioethical Issues.  POGO charges that Gutmann has ignored serious issues of research misconduct by a senior professor of psychiatry at the University of Pennsylvania.  Those issues revolve around published articles about the antidepressant Paxil, which another Penn psychiatrist says were ghostwritten by a firm employed by GlaxoSmithKline. Read the story on the POGO blog..

Update: more on the story at the Philly Inquirer and the Boston Globe.

Monday, July 11, 2011

Whitaker on Kramer on antidepressants

Bob Whitaker, author of Mad in America and Anatomy of an Epidemic, replies to Peter Kramer's defense of antidepressants.

Captain Ahab: Schizophrenic?

Jay Gatsby: narcissistic personality disorder? A teacher of American literature considers what is lost by reducing great characters to a medical diagnosis. Read the results in the Star Tribune.

Sunday, July 10, 2011

Duke cancer scandal

Another research scandal at Duke.  This time it's fraud, plus at least one death.  Read about it in the Times.

In defense of antidepresssants

Peter Kramer, author of Listening to Prozac, thinks antidepressants are getting a bad rap.  Read it here.

Thursday, July 7, 2011

Call for papers on conflicts of interest in medicine

The American Society of Law, Medicine & Ethics will be presenting a conference on Conflicts of Interest in the Practice of Medicine at the University Of Pittsburgh School Of Law on October 27-28, 2011. We are calling for proposals on the following sub-topics, listed below. Anyone selected to participate will be asked to present at the conference in Pittsburgh and soon after prepare a scholarly paper for publication on the topic in a special issue of the Journal of Law, Medicine & Ethics.

Read more here.

Tuesday, July 5, 2011

Social contagion debunked?

Remember all those stories last year claiming that obesity, divorce and even loneliness can be transmitted like viruses?  Maybe it's not quite so simple.  Read about it on Slate.

The Medtronic spine wars

The latest accusations (Stanford v Wisconsin) are here.

New Yorker writer sued for defamation

Read about it here.

Saturday, July 2, 2011

Eleven dead research subjects in a fake study

Everyone knows how Parke-Davis (now part of Pfizer) made billions by marketing Neurontin, a seizure drug, for off-label uses ranging from migraines to ADHD.  Less well-known is the fact that Parke-Davis also marketed Neurontin through so-called "seeding trials."  Seeding trials are fake studies.  They masquerade as clinical trials, but in fact their purpose is not to generate an answer to a legitimate scientific question, but rather to make doctors familiar with a new drug.

It's an old marketing tactic that ordinarily attracts little attention.  What makes the Neurontin seeding trials different is the window on the tactic opened by litigation.  As three expert witnesses in the Neurontin litigation recently wrote in The Archives of Internal Medicine, 73 patients in the Neurontin seeding trials had serious adverse events, 997 had side effects and 11 patients died.  That's eleven deaths in the service of a marketing campaign.  Pfizer was able to settle the off-label marketing lawsuit for $420 million.  Why hasn't it been forced to answer for these eleven deaths?

Friday, July 1, 2011

Mass General disciplines three psychiatrists

Here is something new under the sun: a teaching hospital has actually disciplined its physicians for conflict of interest violations.  According to the Boston Business Journal, the Massachusetts General Hospital has disclosed sanctions against Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens for failing to report the seven-figure payments they received from pharmaceutical companies.  (Of course, the sanctions are not exactly a tremendous hardship in comparison to those seven-figure sums  -- eg, "refraining from all industry-sponsored outside activities" for a year -- but hey, they are a start.)  Read about it here.

Ann Patchett's New "Wonder Drug Novel"

Patchett's new novel, "State of Wonder," is about a medical researcher at a Minnesota-based pharmaceutical company who is sent to the Amazon to investigate the fishy circumstances surrounding the death of her lab partner, who himself had been sent to the Amazon to check on a ruthless doctor the company has been paying to develop a miracle fertility drug.

A review in The New York Times calls the book "an engaging, consummately told tale."

Medical journal blasts Medtronic over biased research

Minnesota Public Radio reports that an editorial published in The Spine Journal blasts Medtronic for sponsoring studies about its spinal bone graft products that (surprise!) made those products look better than they actually are.