Perhaps the F.D.A. should dispense with the pretense that they are genuinely interested in “protecting the public health” and just admit that they are in cahoots with the pharmaceutical industry and their initials really stand for Fast Drug Approval. And perhaps Congress, which seems on the verge of formally expressing its lack of confidence in Attorney General Alberto Gonzales, should offer similar sentiments to the hacks at the F.D.A.
From the New York Times:
Potentially Incompatible Goals at F.D.A.
Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe.
These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.
A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.
The latest to suffer this fate is Dr. Rosemary Johann-Liang, 42, who recommended more than a year ago that the diabetes drug Avandia carry the agency’s strongest possible safety warning for its effects on the heart.
Dr. Johann-Liang spent Friday sadly winding down her nearly seven-year career at the F.D.A. She turned in her BlackBerry, laptop and office key, and she went to the agency library to make sure she had no overdue books. She wished her colleagues well.
A pediatrician and expert in infectious diseases, Dr. Johann-Liang joined the agency in December 2000 and rose through the ranks. For four years, she reviewed drug applications as a medical officer and then team leader.
Two years ago she became a deputy division director in the agency’s office of surveillance and epidemiology, the group that examines the safety of already-marketed drugs.
In February 2006, one of her safety reviewers, Lanh Green, went to her with a problem. The agency’s Office of New Drugs had asked Ms. Green to determine whether eye problems that sometimes resulted from taking Avandia and a similar drug, Actos, were a serious issue. But Ms. Green noted that visual deficits were just one part of a drug-induced swelling problem that could lead to weight gain, ankle swelling and, if left untreated, heart failure.
Alerts about some of these problems were scattered throughout the two drugs’ labels. Ms. Green suggested consolidating them and highlighting the heart risks with a boxed warning, the agency’s most severe. After a weeklong review, Dr. Johann-Liang agreed.
“There’s no doubt these problems are caused by these drugs, and there’s no doubt that patients are continuing to suffer bad outcomes,� Dr. Johann-Liang said.
A week later, top officials from the new drug office walked by Dr. Johann-Liang’s office and into the office of her boss, Dr. Mark Avigan, she said. Nearly an hour later, she said, the door opened, the officials left and Dr. Avigan called her in.
“Mark told me that they were upset with our recommendation,� Dr. Johann-Liang recalled. “They decided to act like the review never happened.�
Dr. Avigan took over the supervision of the safety review of Avandia and Actos and told Dr. Johann-Liang that she could no longer approve strong safety recommendations without his say-so, she said. Over the next year, she was increasingly excluded from crucial safety reviews and meetings, which contributed to her decision to leave the agency on Friday, she said. [full text]
Kmareka.com 
Heaven help those of us who actually try to do our jobs in this world.
I would be interested to know what “top officials from the new drug office” said to her boss. Seems to me, since as taxpayers we are sponsors of the FDA, that conversation should be part of the public record.
Big Pharma & Co. (CDC) have been irresponsible and have poisened our children and elderly with Thimerosal in vaccines. Top officials deny…as their noses grow…and the statistics skyrocket for Autism, Altzheimer’s and other neurological disorders. Then Bush & Co. pass underhanded (unethical) legislation to protect those same pharmaceutical companies. Hey, the polar bears aren’t dying and 1 in 150 children that are in diapers, can’t talk and changed around 18 months are just us illusionaries. There is so much conflict of interest in this industry it isn’t possible to fix it. 85-90% of the money that is earmarked for advertising goes to the doctors benefits like symposiums and free products. It’s an incestious bed – How do you make a bundle in the pharmaceutical industry…humnn let’s poisen people with uncalculated amounts of mercury, formaldeyde and other toxins in shots and then once they are sick….sell them possible annedotes. We can’t let the Bush Administration to continue turning blind eye to what the american’s are being fed. Let’s send him on a glacier and see how he scoff’s at the global warming theory.
The progress medicine in all its forms has made in the last 50 years is greater, by any measurement, than the progress in the preceeding 2000 years. Yet there is a price, literal and figurative that has been paid. Modern medicine is horribly expensive, whether by procedures using new diagnostic or treatment, or the array of medications available. The majority of vast number of of medications, certainly numbering in the thousands, routinely used today were not available 50 years ago. We expect each to be of the highest quality and the least plagued by unexpected side effects. The progress has been spectacular but so have the “temptations” that enormous profits brings, as well as the intense competition between pharmaceutical companies and their sharholders. Fast track government approvals can and have led to significant “errors’ where error can mean unexpected andvery nasty side effects or even death from drugs. The process of approval and testing have sufferred and beed corrupted to some extent by the ceaseless pressure for drug approval and sales. It may be that in some corporate insanity, much like in the infamous example of the Ford Pinto, that little extra time to test more or more carefully screen, is simply not viewed as cost effective. In the case of the Pinto, Ford could have moved the gas tank forward a bit, or better shielded it from rear impacts, but the cost per car impacted profits more than “paying out” claims when that gas tank exploded on impact. The profits accruing to the drug industry are so huge, that perhaps a judgement can be made that the payout from any liability would not significantly impact profit. The guardians of us normal folk must be the federal authorities who insure our safety and no not bow to political or economic pressure that will compromise our safety. As in so many other areas, the choices the current administration continues to make, seem to be less on the side of the vast majority of us, the public, and more on the side of special interests. This is bad policy and worse government.