Healthy Skepticism Library item: 10383

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Publication type: news

Rubin R.
FDA scientist says she was reprimanded for warning
USA Today 2007 Jun 10
http://www.usatoday.com/news/health/2007-06-10-fda-insider_N.htm

Full text:

Rosemary Johann-Liang thought she’d be able to leave her job Friday at the Food and Drug Administration, where she worked for 6½ years, without much fanfare.

“I was trying to leave peacefully,” she said in a telephone interview on the eve of her last day as deputy director of the Division of Drug Risk Evaluation, part of the Office of Surveillance and Epidemiology (formerly the Office of Drug Safety). “I had nice parties last week.”

But then the popular diabetes drug Avandia began making headlines because a prestigious medical journal aired concerns about its safety. Johann-Liang found herself in the media spotlight.

The reason: She took her staff’s advice and recommended in February 2006 that Avandia get a “black box” warning about congestive heart failure. For doing so, FDA staffers told Senate Finance Committee investigators, Johann-Liang was verbally reprimanded and told to talk to her director before making any major recommendations related to drug safety.

FDA spokeswoman Susan Cruzan said Friday that the agency is looking into whether Johann-Liang was reprimanded for her opinion. “We don’t know if that’s actually the case,” Cruzan said.

Last week, Commissioner Andrew von Eschenbach, in written remarks for a House panel hearing, said the FDA is now asking for a black-box warning about congestive heart failure on the labels of Avandia and its cousin, Actos.

“It is our goal to not just make the right decision about a drug like Avandia, but, more important, to always do the right thing by patients,” von Eschenbach told the House Committee on Oversight and Government Reform.

Longtime FDA critic Sen. Chuck Grassley, R-Iowa, ranking member of the Senate Finance Committee, is asking von Eschenbach to make sure no agency scientist is ever reprimanded for raising safety questions. “Those FDA employees ded- icated to post-marketing surveillance … should be able to express their opinions in writing and independently without fear of retaliation, reprimand or reprisal,” Grassley wrote in a letter dated June 4.

Von Eschenbach told the House panel that the FDA “is committed to appropriate scientific dialogue and discussion.”

But, Johann-Liang says, “I really advocate for drug safety, and a lot of times the agency doesn’t want to hear that there are problems. I think, in general, there is a culture of ‘The drug is always innocent.’ “

Part of the problem, she says, is that the Office of Surveillance and Epidemiology can only recommend how to manage risks linked to drugs. The Office of New Drugs, the same office that approves drugs, is the one that decides whether to take action.

With Avandia, Johann-Liang says, “when we recommended this black box, they said they wanted to look at it further.” But the Office of New Drugs never got around to it, she says, because they were pressed to meet deadlines for acting on new drug applications.

In her two years in the Office of Surveillance and Epidemiology, Johann-Liang says, “I worked really hard to institute systematic safety meetings” with the Office of New Drugs. She says Congress needs to increase staffing in the surveillance and epidemiology office and give it the authority “to take action in a timely manner.”

Johann-Liang speaks of a convoluted system in which the FDA requires a higher level of proof of risk than of effectiveness.

The FDA approves diabetes drugs such as Avandia if clinical trials show they meet the “surrogate endpoint,” or goal, of lowering blood sugar, she says, but then doesn’t require makers to do follow-up studies of whether patients actually feel better and live longer.

On the other hand, Johann-Liang says, “if there is a safety issue with the drug, it must be confirmed. I just don’t think that that’s appropriate.” As a result, “we’re not doing things in a timely way.”

Meanwhile, Johann-Liang says, “people are continuing to be hurt.” Congestive heart failure “is a very, very clear adverse reaction syndrome” with Avandia, she says, adding that she’s concerned some patients might blame congestive heart failure symptoms, such as shortness of breath, on their diabetes and take even more Avandia.

The drug’s label has mentioned heart failure for a few years, but “the stuff is all over the label,” so doctors and patients can easily miss it, Johann-Liang says.

In his written remarks to the House panel, von Eschenbach said that although congestive heart failure “is already prominent in the WARNINGS section for both drugs,” FDA has asked for a black-box warning “because, despite the existing warnings, these drugs were being prescribed to patients with significant heart failure.”

Despite her frustrations, Johann-Liang says, she is leaving FDA mostly for personal reasons. Two of her three children are autistic, and, she says, she needs a job with a more consistent workload and hours.

She begins working Monday as chief medical officer in the vaccine injury compensation program at the federal Health Resources and Services Administration. Still, she says, she might have tried to figure out how to stay at the FDA “if the agency had a vision of promoting and protecting public health.”