Sunday, February 27, 2005

US FDA Mixed Reviews;
What is the Public to Think?

First, let me say this.  The world is better off with the FDA than it would be without the FDA.  Although the US FDA has no authority outside the US, its actions have significant effects around the world.  For the most part, those effects are positive.  Anyone reading the news lately is likely to have at least some degree of skepticism about the effectiveness of the FDA.  A recent editorial in Newsday indicates that public confidence in the FDA has declined:
It [the FDA] was the gold standard of trustworthiness, both for the patient and the prescribing physician. Even drug manufacturers impatient with the long process coveted FDA approval, for it meant their drugs were safest; American drugs were the safest in the world.

Lately, however, the FDA's credibility has fallen on hard times. According to a recent CNN-USA Today-Gallup Poll, nearly 40 percent of 1,015 adult respondents said their confidence in the FDA has slipped during the past year.
What the Gallup Poll does not tell us is whether the declining confidence in the FDA is merely a reflection of increasing public realization that the government is more pro-business than pro-people.  Still, if taken at face value, the survey indicates that public perceptions are becoming more negative.  To what extent is this perception valid?

Undoubtedly, the organization  does have flaws.  The British Medical Journal posted an article yesterday, pointing out the deficiencies of the new drug safety oversight board. 
Dr Sidney Wolfe, director of Public Citizen's health research group in Washington, DC, said that the new board would only be an advisory body, relying on information from the FDA's Center for Drug Evaluation and Research, which itself stands accused of being too slow to move on safety and too close to one of its major sponsors, the drug industry. Dr Wolfe said that the new board will be a "toothless tiger" unless the opinions of the FDA's Office of Drug Safety are given more weight and enabled to prevail.
The BMJ included a comparison between the US FDA and the corresponding agencies in Britain and in Australia.  The British system has been criticized, mostly for being too slow to respond to indications of potential problems.  The Australian system might be better, in part because there is more separation between those who approve drugs, and those who monitor safety. 

The Chicago Tribune posted an article that was more detailed, and more critical:
Safeguards designed to protect Americans from potentially dangerous medications are being eroded by conflicts between federal bureaucrats who approve new drugs and those who oversee their safety, according to former and current officials at the U.S. Food and Drug Administration.

FDA regulators rush to review applications for new medicines but are slow to address serious problems that surface with the drugs once they come on the market, interviews with physicians, scientists, government officials and medical school researchers suggest. [...]

Last week, the administration sought to defuse some of the criticism aimed at the FDA, saying it would appoint a permanent commissioner--a position that has been vacant for almost a year--and create a new Drug Safety Oversight Board. The president's budget also shored up funding for the FDA's current Office of Drug Safety.

But critics say those actions do not fully address deep-seated flaws plaguing the FDA, including conflicts of interest, a lack of attention to safety issues and a lack of authority in forcing industry to heed its recommendations.
The Associated Press released an article illustrating a potential conflict of interest:
Ten members of the Food and Drug Administration (news - web sites) advisory panel who voted that a group of powerful pain killers should continue to be sold had ties to the drug makers, an advocacy group says.

A study by the Center for Science in the Public Interest indicates that 10 of the 32 panel members had ties to either Pfizer Inc. or Merck & Co., ranging from consulting fees and speaking honoraria to research support.
Of course, consulting fees and speaking honoraria do not necessarily create a significant conflict of interest.  The FDA has internal mechanisms for panel members to declare potential conflicts; a well-run organization can deal with such issues, without compromising public safety. 

Getting back to the original question, how valid is the public perception that the FDA is becoming less effective at protecting public safety?  There have been changes in the operation of the FDA, and those changes have led to quicker approval for many drugs.  In return, the pharmaceutical companies were supposed to increase their post-marketing surveillance of the safety of their products.  Some have argued that this has not happened.  The recent Vioxx problem may have arisen, in part, because of this. 

Unfortunately, single case studies do not really tell us what we want to know.  We may find a few cases in which drugs were put on the market, then not withdrawn promptly when there were signs of safety problems.  But what we really need to know is this: have the changes in the FDA resulted in more harm than good?  Presumably, getting drugs to market faster does result in some improvemnts in overall public health.  It also may entail some risks.  But finding a few cases of risk tells you nothing about the overall effect of the changes.   I've been looking for a few months now, albeit rather casually, and have not come upon anyone trying to answer this question.  So the fact is, we do not know whether the public should have a declining opinion of the FDA.

It is likely that quicker approval of HIV/AIDS drugs has resulted in many saved lives, or at least additional good years for those who ultimately succumb to the illness.  Quicker approval of arthritis drugs may not have actually extended anyone's life, but it probably added years of productive life for many people.  Similar arguments could be made for all categories of drugs. 

In addition, we need to understand that no regulatory process will eliminate risk.  Indeed, that is not the goal of the process.  The goal of the process is to quantify the risk as accurately as possible, so people can make informed choices.  It is common for patients to choose to take a drug, despite known risks.  There is nothing wrong with that, so long as the patient has the opportunity to make an informed choice.  

Some patients may decide to take the risk, even if an appropriate regulatory agency would advise against it.  Here's an example: the Vioxx controversy occurred, in part, because doctors ended up given the drug to people who did not fit the profile of patients for which the drug was approved.  This meant that a lot of people got exposed to the risks of the drug, people who --some may argue -- should not have taken the drug.  But let's say a patient has migraine headaches, occurring two to three times per week.  The patient is at risk of loosing her job.  She finds that Vioxx works very well for her.  Vioxx was not approved for treatment of migraine.  Who can tell her that she should live with the pain, and suffer the financial consequences, rather that take the drug and run the risk of cardiovascular complications?

Most of the editorials focus on the problems, not the benefits, of the approval process.  Personally, I think we need to reserve judgment on that question.  Even so, that does not free the government from the obligation to make sure that the FDA is operating as effectively as possible to discharge its primary missions.  That is, even if some study eventually shows that the current approval process has created more benefit than harm, we still need to see if it can be made better. 

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Vioxx health - Merck Earns Fall After Vioxx Withdrawal NEW YORK (Reuters) -

Merck Earns Fall After Vioxx Withdrawal
NEW YORK (Reuters) - Merck & Co. MRK.N on Thursday said first-quarter profit fell 15 percent following the withdrawal of its arthritis drug Vioxx last year. Link to original article
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