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By Alison Bass (cross-posted)

At a talk I gave Wednesday at George Washington University, someone in the audience asked why there seemed to be an inordinate number of psychiatrists on the take to the drug industry. Was it something about the specialty of psychiatry itself or the individuals involved? I have often pondered the same, especially since this is not simply an anecdotal observation. In 2007, The New York Times examined the payments made to all doctors in Minnesota in the years since that state passed one of the first laws in the nation requiring the public disclosure of payments from the pharmaceutical industry. Based on that investigation, Times reporters concluded that as a specialty, psychiatry topped the list in lucrative drug company payments.

So what’s going on? A couple of things, I think. First off, there’s a reason why drugs like Paxil, Zoloft, Prozac and Lexapro are top sellers: it’s easier to expand the criteria for who might benefit from these drugs. After all, almost everyone has experienced depressive or anxious symptoms at one time or the other, so if the makers of these drugs can reach psychiatrists and persuade them to prescribe pills for such universal symptoms, we’re talking real profits here. And what better way to influence psychiatrists’ prescribing behavior than to put their most prominent colleagues — the key opinion leaders (KOLs) — on your payroll?

Secondly, as someone who came to the talk astutely noted, psychiatrists have been squeezed by managed care into the role of pill prescribers. Unlike other medical specialties, doctors in psychiatry don’t get adequately reimbursed for treating the whole patient — by doing psychotherapy, for instance — so all they can do these days is prescribe drugs. In a sense, psychiatrists are gatekeepers for the pharmaceutical industry, much like surgeons (who put in stents and other devices) are gatekeepers for the medical device industry.

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Alison Bass, an award-winning journalist and Pulitzer Prize nominee, will be here at George Washington University tomorrow to speak about why the system of drug research and development in the United States is seriously flawed and what reforms are needed.

Wednesday, March 18, 4:30pm
GWU-SPHHS Health Policy Department
2021 K St. NW, Ste. 800, Washington, DC
Sponsored by the EOH and Health Policy Departments

Bass is the author of Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial; copies will be available for purchase and signing at the event. The book tells the true story of two remarkable women who exposed the deception behind the marketing of bestselling antidepressant Paxil.

Also, whether or not you’re in the DC area, Bass’s blog is a great source of information on the problems associated with today’s model of pharmaceutical marketing. For instance, check out her posts on the fraud case of anesthesiologist Dr. Scott Reuben;  the DOJ lawsuit against Forest Labs over their marketing of antidepressants Celexa and Lexapro; and Emory University’s treatment of psychiatrist Dr. Charles Nemeroff, who had failed to disclose hundreds of thousands of dollars in personal payments from Paxil maker GlaxoSmith Kline.

Last fall, we warned that a Supreme Court decision on medical device companies’ liability would remove a powerful incentive for device manufacturers to ensure their products’ safety. In that case, Riegel v. Medtronic, the Court ruled that as long as devices are FDA-approved, consumers injured by the devices can’t sue the manufacturers for liability in state courts – in short, FDA approval preempted those lawsuits. This wouldn’t be such a problem if FDA weren’t such a woefully under-resourced agency.

We feared that the Court might again rule in manufacturers’ favor in a similar case, this one involving pharmaceuticals. But in Wyeth v. Levine, the Court upheld a jury verdict awarded to musician Diana Levine, whose arm had to be amputated after an incorrectly administered injection of Wyeth’s anti-nausea drug Phenergan. (Levine claimed Wyeth’s warning against the administration method she received should have been stronger.) The New York Times’ Adam Liptak explains why the Court’s decision on pharmaceuticals differed from its decision on medical devices, and what the larger implications are:

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DC-area readers, mark your calendars: Alison Bass, an award-winning journalist and Pulitzer Prize nominee, will be here at George Washington University on Wednesday, March 18th, to speak about why the system of drug research and development in the United States is seriously flawed and what reforms are needed.

Wednesday, March 18, 4:30pm
GWU-SPHHS Health Policy Department
2021 K St. NW, Ste. 800, Washington, DC

Bass is the author of Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial; copies will be available for purchase and signing at the event. The book reads like a legal thriller (I just started it, and had a hard time putting it down), and tells the true story of two remarkable women who exposed the deception behind the marketing of bestselling antidepressant Paxil.

This event is sponsored by the Environmental & Occupational Health Department and the Health Policy Department of the George Washington University School of Public Health and Health Services.

Members of the media are gravely enumerating all the challenging circumstances that President-Elect Obama faces (financial collapse, two wars, global climate disruption, etc), so it’s worth noting that this is also a tough time for product safety. Recent problems with lead in children’s toys, contaminated food, and tainted drugs have demonstrated how many holes exist in our systems for ensuring product safety, and China’s melamine problem highlights how problematic it can be to rely on countries whose safety mechanisms are even weaker.

Here’s a quick review of where things stand:

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by Susan F. Wood, PhD

Recently the New York Times and RHRealityCheck reported on a leaked internal proposed regulation that calls for more and different enforcement of anti-discrimination provisions for health care providers.  The provisions are forms of conscience clauses that do not allow discrimination in hiring or promotion of health care workers who do not wish to perform abortion or sterilization (or indeed in the reverse, no discrimination against those who do perform abortions or sterilizations) in federally funded settings.

The draft regulation goes into detail outlining the history of the laws protecting the conscience of health providers and entities and then outlines the problem.  It seems that the central concern is not discrimination against those who won’t perform abortions, but that the US Department of Health and Human Services sees a real problem with requiring health professionals (and anyone in the healthcare workforce) to be involved with contraception, even if it is part of the job.  The majority of the section outlining “The Problem” concerns states that have passed laws or issued executive orders requiring pharmacies to dispense contraception, including emergency contraception, and that require hospitals to provide emergency contraception to rape victims. 

From the regulation:

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by David Egilman, MD, MPH

I just finished watching the Waxman hearings on FDA preemption and must comment on Christopher Shays’ (R-CT) comments.  Christopher Shays is the last remaining Republican congressman from New England.  Hopefully the November elections will result in the extinction of this last remaining
remnant of the age of the dinosaurs.

He repeatedly stated that he “had no dog in this hunt” concerning the impact of preemption and torts suits on drug safety. This is a peculiar position for a Congressperson who must decide whether or not the FDA’s actions are appropriate.  It’s one thing to have no opinion; it is in another to imply that there is no reason to have opinion.

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After so many stories about tainted drugs and food, here’s some good news for a change: The FDA plans to hire hundreds of new employees to help it fulfill its responsibilities to assure the safety of food, drugs, cosmetics, and medical devices.

They’ve identified a critical need for “medical officers, consumer safety officers, chemists, nurse consultants, biologists, microbiologists, health/regulatory/general health scientists, mathematical statisticians, epidemiologists, pharmacologists, pharmacists and veterinary medical officers” in their DC-area office as well as U.S. regional and district offices and their newly created overseas office.  Here’s their complete press release:

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The winners of the 92nd annual Pulitzer Prizes were announced yesterday, and reporting on veterans’ care and on drug and product safety scored top honors in the journalism category:

The Public Service prize went “to the Washington Post for the work of Dana Priest, Anne Hull and photographer Michel du Cille in exposing mistreatment of wounded veterans at Walter Reed Hospital, evoking a national outcry and producing reforms by federal officials.” The Post’s Walter Reed and Beyond website includes the original stories and slideshows, as well as reporting on the federal response.

The Investigative Reporting prize had two winners: “Walt Bogdanich and Jake Hooker of The New York Times for their stories on toxic ingredients in medicine and other everyday products imported from China, leading to crackdowns by American and Chinese officials”; and “the Chicago Tribune Staff for its exposure of faulty governmental regulation of toys, car seats and cribs, resulting in the extensive recall of hazardous products and congressional action to tighten supervision.” The New York Times doesn’t appear to have a special page dedicated to Bogdanich and Hooker’s reporting, but their initial article is here and others are listed here; the Chicago Tribune has a Kids at Risk website for its articles and resources.

Congratulations to the newspapers, reporters, and staff for their excellent work – and thanks to all of the journalists who are drawing attention to health and safety shortcomings and prompting officials to address them.

by Susan F. Wood, PhD 

The FDA Amendments Act (FDAAA) of 2007 includes a small section addressing direct to consumer (DTC) advertising.  The bill doesn’t limit advertising to consumers, nor does it give FDA authority to put a moratorium on advertising while more data on safety or effectiveness is collected during the first months or years that a product is on the market.  A moratorium was recommended by the IOM in it’s drug safety report in 2006, but was not adopted by Congress – perhaps due to arguments about first amendment rights, but perhaps due to objections by both the pharmaceutical industry and the advertising industry.

What was included is a small section requiring that all print DTC ads carry “the following statment printed in conspicuous text:  ‘You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088′ ”

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