Pharm Exec Q&A: A Soft Spot for Whistleblowers - Pharmaceutical Executive

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Pharm Exec Q&A: A Soft Spot for Whistleblowers
FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive Pharm Exec interview, he explains where the agency goes wrong—and what he would do to fix it.


Pharmaceutical Executive


As chairman of the Senate Finance Committee, Senator Charles (Chuck) Grassley, a Republican from Iowa, wields enormous clout in Washington. His committee oversees taxes, international trade, Social Security, and Medicare. Grassley keeps close tabs on agencies charged with executing Congressional mandates, including FDA. If it cozies up too tight with the industry, or downplays safety data that he thinks consumers need, the self-described "common-sense Iowan" says he "sinks his teeth in" and doesn't let go until the problem is solved.



The federal government spends hundreds of billions of dollars on prescription drugs each year, and Grassley is determined that US taxpayers will pay only for safe and effective medicines. But investigations and reports by whistleblowers have convinced the senator that FDA does not protect the public as it should. He has accused the agency of "sweeping safety data under the rug" when it looked at antidepressants for children, ADHD drugs, and Merck's painkiller Vioxx (rofecoxib). Not to mention the "runaround" he gets when he asks for information on the side effects of Ketek (telithromycin), an antibiotic by Sanofi-Aventis. Grassley backs legislation to overhaul FDA's drug-safety reviews, liberalize curbs on drug imports, and eliminate conflicts of interest. He says safety comes up short in DTC ads, and he wants FDA to better protect patients in clinical trials.

Pharmaceutical Executive's Washington correspondent Jill Wechsler recently discussed these and other concerns with Senator Grassley. The Senator emphasized that FDA needs new permanent leadership, but hedged on whether he thinks Andrew von Eschenbach is the right man for the job. Those he does like: whistleblowers great and small.

Pharm Exec: Why do you think FDA is in trouble, and what would you do to fix it?

Grassley: As a starting point, Senator [Christopher] Dodd and I have introduced legislation that offers some improvements. One bill would require that all clinical trials—both positive and negative—for all drugs would be posted on the Internet so that all the information would be made public. The other bill would make the Office of Drug Safety [recently renamed Office of Surveillance and Epidemiology] entirely separate from the Office of New Drugs.

That's the legislative piece. From the standpoint of the agency itself, in most of the last six years, it hasn't had permanent leadership. So getting a commissioner that will do the job right, and getting him in there full-time, is important.

You have talked about a broader cultural problem within FDA. Why is that a concern?

There is a culture within the FDA that's more worried about its public relations than it is about patients. Now I can say the same thing about the FBI, and I have. It may not just be an FDA problem, but a culture problem in all government. You see it, for instance, when the Office of New Drugs approves something, and the Office of Drug Safety raises questions about it. The Office of New Drugs doesn't want egg on its face, so it tries to squash the controversy.

In the end, you lose proper respect for the scientific process. For a non-scientist like me, that means if you have a good idea, it should be subject to peer review so that the science will prove if it's right or not. In the case of FDA, the key issue is whether the drug is safe and effective. But dissident points of view are not getting proper respect. Events have proven that they were right: We see that Vioxx is off the market and that antidepressants for kids have a black box. But the scientific process has been compromised, and it's all about the public relations of the organization.

And lastly, it seems to me, the relationship between FDA and pharmaceutical companies is too cozy. We see evidence of this in some of the telephone notes and e-mails we've had access to. It's just not right. The only person that should be across this table from the FDA is John Q. Public. It seems like FDA officials see themselves too much as facilitators working with the drug companies—instead of regulators.


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