Dr. Gottlieb is Not Happy

It was an uncomfortable moment.

There they sat -- next to each other.

Dr. Steven Nissen, chair of the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation.

And Dr. Scott Gottlieb, deputy commissioner for Medical and Scientific Affairs at the Food and Drug Administration (FDA).

Next to each other they sat.

Fidgeting.

Nervous.

Dr. Nissen and Dr. Gottlieb -- along with four others gathered to discuss the question: "Government Science Panels: Fair and Balanced?"

The panel was moderated by a reporter -- National Public Radio's Snigdha Prakash.

The panel was sponsored by the Center for Science in the Public Interest, which the day before had released a report -- Ensuring Independence and Objectivity at the National Academies.

The report found that nearly one out of every five scientists appointed to National Academy of Sciences panels has direct financial ties to companies or industry groups with a direct stake in the outcome of the study.

But Cleveland Clinic's Dr. Nissen said he wanted to go beyond the narrow topic the panel was brought together to discuss.

Dr. Nissen wanted to address the bigger issue of the "imbalance of power between the FDA and industry."

"The American people no longer trust the FDA to protect their health," Dr. Nissen said. "Patients are increasingly suspicious of drug therapy and sometimes reluctant to accept potentially life-saving medications.

How did we get into this predicament?"

Dr. Gottlieb squirms.

The entire FDA budget for drug regulation is about $500 million and relies extensively on user fees, Dr. Nissen said. User fees are paid by drug companies seeking marketing approval and those with drugs on the market, and by law may only be used to fund the marketing approval process -- not FDA's other functions, like safety reviews of drugs already on the market.

As a result, the FDA is financially indebted to the companies it must regulate.

Forget about NAS and government agency panels.

This is the elephant in the room -- the big conflict of interest.

"Industry spends more than $48 billion on marketing, complete with a dazzling array of direct-to-consumer advertising touting the latest sleeping pills or even creating entirely new diseases like 'restless leg syndrome,'" Dr. Nissen said.

We must adequately fund the FDA -- without user fees, Dr. Nissen said.

And plus, the FDA needs new laws to strengthen its authority over the industry.

Dr. Gottlieb fidgets.

"Currently, the FDA must negotiate with industry to make even simple changes in drug labels," Dr. Nissen said.

"When drug studies reveal toxicity or lack of efficacy, the FDA is not permitted to release the results and the findings are often not published, thereby denying patients and physicians access to vitally important safety information. Why has the FDA not sought to strengthen its regulatory authority?" Dr. Nissen asks. "Well, that brings up yet another conflict-of-interest problem, evident at the highest levels of the FDA."

The FDA's Dr. Gottlieb nervously checks his Blackberry-like device.

He doesn't like what he sees coming.

Dr. Nissen starts at the top.

"For years, we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies," he says.

"Then the administration appointed Andrew Von Eschenbach as interim commissioner, creating another conflict,"

Dr. Nissen says. "In his role as director of the National Cancer Institute, Von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict."

Dr. Gottlieb is not happy.

"Even worse, the administration appointed Scott Gottlieb as deputy commissioner," Dr. Nissen says. "He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter. Between them, Drs. Von Eschenbach and Gottlieb have whined incessantly about the need to speed drug development. So while the American people worry about the safety of drugs, the top FDA leadership tells us we need faster drug approval."

Dr. Nissen speed reads through the remainder of his talk.

FDA's Dr. Gottlieb is next.

And he's still not happy.

But he gets up and brushes off the criticism with -- I know nothing about what Dr. Nissen said -- I'll stick to the subject at hand and delivers my prepared remarks.

In November 2005, the Boston Globe reported that Dr. Gottlieb worked for the public relations firm of Manning Selvage & Lee and had corporate clients that included Roche, the manufacturer of the antiviral Tamiflu, and Sanofi-Aventis, parent company of the nation's sole flu vaccine manufacturer.

Other firms he was involved with, according to the Globe, included Inamed Corp., one of two companies seeking to return silicone gel implants to the market -- and VaxGen Inc., a California firm that won a $878 million federal contract to supply 75 million doses of anthrax vaccine for the nation's protective stockpile.

During the question-and-answer period, we asked Dr. Gottlieb about Dr. Nissen's remarks and about the conflicts.

We prefaced the question with some facts from a 2005 newspaper report.

Dr. Gottlieb used to work at the American Enterprise Institute and he authored a column called the Forbes/Gottlieb Biotech Investor.

And he had a blog called the fdainsider.com -- since shut down.

Back in September 2005, the Daily Deal, a daily news outlet that covers Wall Street, warned that "watchdogs should keep an eye on Gottlieb's relations with former clients."

"His recent writing is rife with potential conflicts," according to the report by Alex Lash of the Daily Deal. "For example in an AEI paper, Gottlieb cites VaxGen as a victim of political meddling. In a footnote, he adds that he did consulting work for the company. And his Forbes columns are tagged with similar warnings that he 'may own stock or consult with firms' affiliated with his coverage."

So, what about it, Dr. Gottlieb?

"I'm not going to dignify the whole question -- it's not really a question -- it's a statement," Dr. Gottlieb shoots back. "But I complied with every requirement that was put on me. And that's not what I came here to discuss. I came here to discuss how we can move the agenda forward at the agency in dealing with some of these difficult issues related to these kinds of perception problems. And we're doing just that."

We wanted to ask a follow-up question about the perception problem, about Dr. Nissen's observation that the practice of having industry people like Dr. Gottlieb in positions of authority at the FDA is perpetuating the problem -- in fact is an integral part of the problem.

But NPR reporter Prakash wouldn't allow the follow up.

"I think we should move on," she says.

That brought a little cheer to Dr. Gottlieb.

But the rest of us shouldn't be happy.