Three Sheets to the Wind

Three Sheets to the Wind

Congressman Bart Stupak totally gets it.

As the chair of an oversight subcommittee, he’s held numerous hearings to investigate FDA inadequacy and corruption.

And oh the things he’s seen. And he’s had it up to here. And he wants to share.

Core mission abandoned

Earlier this month, Rep. Stupak made a bold suggestion: Don’t fill the FDA Commissioner’s spot with any current senior FDA employees.

As reported in PharmaTimes, Rep. Stupak states that agency senior staff members are “too close with the industries they regulate, creating a question of whom they are working for.”

Well put! But here’s the slammer: “The subcommittee’s investigations revealed how the current FDA senior management blocked clinical trials, drove dedicated medical professionals out of the agency and lined their pockets with outrageous bonuses.”

And he adds, “The agency has abandoned its core mission of protecting Americans from contaminated food, unsafe drugs and medical devices.”

Congratulations, Rep. Stupak. You’ve got the FDA down cold.

PharmaTimes reports that Rep. Stupak and several other Congressmen may be backing Peter Rost for the top spot. At first, this seems like a daring choice. Rost, once a Pfizer VP, is now embroiled in whistleblower litigation with his former company.

Apparently Mr. Rost has seen the light and come over from the Dark Side. But really…could a former drug company executive be trusted to lead the FDA? I have my doubts. I also have another idea…

Inside out

I’d like to place a name in nomination for FDA chief: Dr. David Graham.

Dr. Graham is a longtime FDA insider who I’ve featured in several e-Alerts. Now some might see that FDA connection as a strike against him, but I don’t think so.

You want whistleblowing? In 2004, Dr. Graham told his supervisors at the FDA that Vioxx was a dangerous drug that prompted thousands of heart attack deaths. Contrary to the agency’s official position on Vioxx, he advised banning of the drug.

When Congress investigated the Vioxx mess, Dr. Graham not only revealed the sordid truth about the drug, he also exposed the FDA’s hand in the matter, stating: “The FDA, as currently configured is incapable of protecting America against another Vioxx. We are virtually defenseless.”

Time and again, Dr. Graham has been the loudest voice warning about unsafe drugs, such as the antibiotic Omniflox (pulled from the market in 1992), Rezulin (a diabetes drug pulled in 2000), and others.

For doing his job, Dr. Graham has often been publicly criticized by officials in his own agency. So within the halls of the FDA, I expect Dr. Graham would be considered the worst possible Commissioner. Which is why I believe he would be the best possible Commissioner.