Pharmola.com

FDA scientists complain to Obama of 'corruption' 

By RICARDO ALONSO-ZALDIVAR 

January 8, 2009 WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration. 

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead. The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. 

The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx. The FDA declined to publicly respond to the letter, but said it is working to address the concerns. 

Purple Heart Is Ruled Out for Traumatic Stress

By LIZETTE ALVAREZ and ERIK ECKHOLM

Published: January 7, 2009

The Pentagon has decided that it will not award the Purple Heart, the hallowed medal given to those wounded or killed by enemy action, to war veterans who suffer from post-traumatic stress disorder because it is not a physical wound.

The decision, made public on Tuesday, for now ends the hope of Iraq and Afghanistan veterans who have the condition and believed that the Purple Hearts could honor their sacrifice and help remove some of the stigma associated with the condition.

The disorder, which may go unrecognized for months or years, can include recurring nightmares, uncontrolled rage and, sometimes, severe depression and suicide. Soldiers grappling with PTSD are often unable to hold down jobs.

US university psychiatrist loses chairmanship over drug company payments
British Medical Journal 

Janice Hopkins Tanne

Charles Nemeroff, a psychiatrist and expert in depression and mood and anxiety disorders, has lost his post as chairman of the department of psychiatry and behavioural sciences at EmoryUniversity in Atlanta, Georgia, because of payments from drug companies that he had not disclosed.

In October, Dr Nemeroff, who had chaired the department for 17 years, temporarily stepped down after the Senate finance committee found that he had received payments from GlaxoSmithKlineand other companies but had not reported them to the university or to the National Institutes of Health as required. Emory then set up a new conflict of interest office (BMJ 2008;337:a2200).

New York Times editorial: "No Mugs, but What About
Those Fees?" (1/5/09)

New pharmaceutical industry guidelines should stop most drug companies from distributing a wide range of trinkets and office supplies designed to keep their brand names before doctors as a subliminal inducement to prescribe high-priced drugs.

The new code, which kicked in on New Year’s Day, bars the free distribution of everything from pens to coffee mugs and staplers by some 40 drug companies that have agreed to the restrictions. That may seem like small potatoes, but in the aggregate the promotional products probably cost about $1 billion a year, as Natasha Singer reported in The Times.

The updated rules are the industry’s latest attempt to restore public confidence that doctors are prescribing medicines in the patient’s interest. The code still has too many loopholes.

 

AstraZeneca row as corruption
claims engulf Nobel prize

The integrity of the Nobel prize was called into question last night after it emerged that a member of the jury also sat on the board of a pharmaceuticals giant that benefited from the award of this year’s prize for medicine.

Prosecutors were studying whether AstraZeneca, the London-based multi-national pharmaceutical company, could have exerted undue influence on the award.

The joint winner of this year’s Nobel Prize for Medicine, Harald zur Hausen, was recognised for his work on the human papilloma virus (HPV), which can lead to cervical cancer. AstraZeneca has a stake in two lucrative vaccines against the virus.

Two senior figures in the process that chose Mr zur Hausen have strong links with the pharmaceutical company, which has also recently begun sponsoring the Nobel website and pro-motional subsidiary. The company strongly denies any wrongdoing.

Psychiatrists under fire supported by Mass. General

By Elizabeth Cooney 

June 11, 2008 

Three Harvard psychiatrists facing a US Senate inquiry got a vote of confidence from their hospital as "beloved and trusted by thousands of grateful children and families." Senator Charles Grassley is looking into the doctors' failure to report payments of more than a million dollars in consulting fees from drug makers from 2000 to 2007.

A memo from top officials at Massachusetts General Hospital obtained by the Globe praised Drs. Joseph Biederman, Timothy Wilens, and Thomas Spencer as "pioneers in the field of child mental health" while also endorsing "closely managed" collaboration with industry and promising a review of conflict-of-interest policies.

"They are beloved and trusted by thousands of grateful children and families who have counted on them for treatment, counseling, help and hope. We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them," Dr. Peter L. Slavin, hospital president, and Dr. David F. Torchiana, head of Massachusetts General Physicians Organization, write.