ReputationRx

A new report from the Government Accountability Office found irregularities in how the Food and Drug Administration evaluated the morning-after pill for over-the-counter status.

A new report from the Government Accountability Office found irregularities in how the Food and Drug Administration evaluated the morning-after pill for over-the-counter status.

Regardless of where someone stands on the abortion debate, it is unthinkable that the FDA's senior officials attempted to hijack the scientific process for political or other reasons.

The debate extends beyond the morning-after pill, which is sold by Barr Laboratories under the brand name Plan B. Dr. Susan Wood, who resigned as the head of the Office of Women's Health, has attempted to make that distinction clear.

With the help of agency DDB Issues & Advocacy, she is traveling the country promoting the idea of "scientific integrity," or the idea that research and development should be untainted by the biases of those individuals conducting or evaluating it.

Take the HPV vaccine currently being developed by Merck. As a scientific discovery, it is a remarkable advance, with the potential to save thousands of lives each year ? to say nothing of the cost savings that the healthcare system would realize if it could invest in preventing cancer rather than treating it.

Yet conservative and religious advocacy groups have launched campaigns to spread the message that the vaccine will encourage premarital sex among teenagers, by reducing the fear of catching this sexually transmitted disease.  

Partnering with third party advocacy groups can give a tremendous boost to a healthcare campaign by helping to publicize new research among targeted audiences. Moreover, the public often places greater trust in these groups than in private companies or government officials.

But the role of these groups should be limited to disseminating information, not interfering in the scientific process.

Granted, there is no firm evidence that the FDA was pressured ? from the White House, Congress, or third-party organizations ? to take the unusual steps it did when it evaluated Plan B.

But the FDA is nevertheless facing a serious credibility hurdle. If the FDA's leadership had the gall to disregard the recommendations of its independent advisors in this instance, what is to say that the agency would not do the same in another?

Put another way, if the FDA can be successfully lobbied by one constituency ? the conservative right ? would it be a stretch to believe that the agency is under the thumb of the politically influential drug industry, which invests millions of dollars in protecting its interests on the Hill?

There might be debates about the social ramifications of new scientific advances ? be it face transplants, stem cell research, cloning, or treatments for STDs ? but it is vital that individuals trust the scientific process.

Without that trust, the FDA will compromise its ability to credibly communicate the risks and benefits of new drugs.

The FDA has declined to explain the irregularities raised by the GAO. That is the wrong tactic.

The agency's leadership must take a strong stance against even the suggestion that anything but scientific evidence is considered when a drug is up for review. The FDA's independence is at the heart of its credibility and reputation.

 

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