FRONTLINE: Dangerous Prescription
Andy Liebman
Writer, Producer, Director
Friday, November 14, 2003; 11:00 a.m. ET
As medications play an ever-increasing role in modern health care, the importance of FDA approval to consumers, it would seem, has never been greater. For many consumers, the phrase "FDA approved" signifies that a drug or product is completely safe and without risk. But just how much does the average American know about the FDA approval process and what it can—and cannot—do? How good is the FDA's system for identifying drugs that don't work or cause harm? And what
happens when a harmful product makes its way into consumers’ hands?
In "Dangerous Prescription" FRONTLINE investigates the FDA and drug safety, and questions whether the current system is adequate for protecting the public.
Producer, writer and director Andy Liebman will be online Friday, Nov. 14 at 11 a.m. ET, to discuss the film and the likelihood of harmful drugs making it through the FDA approval process.
Submit your questions and comments before or during the discussion.
"Dangerous Prescription," airs Thursday, Nov. 13 on PBS. (check local listings)
Editor's Note: washingtonpost.com moderators retain editorial control
over Live Online discussions and choose the most relevant questions for guests and hosts; guests and hosts can decline to answer questions.
Frankfort, Ky.:
Hi Andy,
What are your recommendations in improving the FDA approval process?
Andy Liebman: Please keep in mind that I am not an expert on the FDA. I am a journalist who has listened to many current and former FDA insiders who told us there were some serious problems brewing inside the FDA that need addressing.
That said, there ARE some obvious targets for improvement.
The FDA surely needs to cooperate with pharmaceutical companies so that the companies don't waste their time conducting studies that will later be rejected by reviewers. There wasn't enough of that cooperation in the past, we are told. But now things have swung the other way. The FDA needs to go back to having a more distant relationship with the companies it regulates.
Congress needs to give the agency the money it needs to do its job. And the money needs to come not from industry but from taxpayers. We are told by FDA insiders that there is an atmosphere at the agency that the scientists and administrators there "work for industry", that "industry is their client". Congress must elmininate this atmophere if we are to have an FDA that can do its job.
But that probably means that Congress has to reduce its own hunger for contributions from pharmaceutical companies. Otherwise our politicians find themselves having to do the work of industry lobbyists.
Also, we are told that FDA Advisory Committees need more independence from the companies whose products they are evaluating. Typically, a large percentage of any advisory committee is made up of scientists who have financial connections to the companies.
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Nashville, Tenn.:
Which party has the most responsibility (gov or pharma) for post clinical trial research and data gathering?
Andy Liebman: The FDA doesn't conduct any clinical trials -- before or after approval. It is the responsibility of pharmaceutical companies to keep tabs on what's happening with a drug after approval.
The FDA often makes so-called "Phase 4" post approval studies a condition of approval -- so that lingering questions about safety and efficacy finally get answered. I can't give you the statistics but commonly the pharmaceutical companies NEVER carry out those trials. There is some effort being made in Congress (by Congressman Stupak, for example) to get companies to live up to their obligations. But these measures typically get voted down.
Ask your Congressman why?
As for data gathering, we explained this in the show. Both the FDA and companies collect data after approval. Sometimes doctors submit reports directly to the FDA. Sometimes they get sent to the companies, which are obligated to send them to the FDA.
Companies are only required to send the data to the FDA, not to analyze it or point out that something new and serious has been discovered. And the FDA is too short-staffed to pick up all the important developments that get sent in.
The agency IS trying to improve the situation by installing more sophisticated computers that will help staff members to notice new and important side effects.
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Nashville, Tenn.:
Are you aware of any systematic technological efforts to insure that the doctors, government or public is better informed as to the drug interactions or reactions that are manifested with patients other than initial clinical trials?
Andy Liebman: This is a big questions. Let me mention a few things.
Dr. Raymond Woosley from the University of Arizona in Tucson runs something called a CERTS center -- the purpose of which is to study the interactions between drugs. Drug companies conduct only very limited studies on drug-drug interactions before approval. Usually they only look at how their product interacts with a few specific drugs that have caused big interaction problems in the past. Dr. Woosley and his are trying to be much more thorough and systematic. Check out what he's doing at:
http://www.certs.hhs.gov/
So, the first step is to collect information about drug interactions. So little of it exists today.
Then, the next step is to inform doctors and the public about the results. Dr. Woosley and his team are thinking about that too.
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Rochester, N.Y.:
Why did you not comment on the European experience with drug approval? Most of their post-marketing phase 4 trials are already published before the FDA application can be submitted. Examples include metformin and photorefractive keratotomy. Your documentary made it seem that the FDA operates in a vacuum and that the U.S. experience is the only valid experience regarding drug approval.
Andy Liebman: We did actually talk about a European post marketing study -- the International Primary Pulmonary Hypertension Study that was conducted on diet drugs at the request of European regulators. That information was present to members of the FDA Advisory Committee that considered Redux. And of course FDA reviewers had that information too.
Sometimes drugs come up for approval in the US when they have already been on the market elsewhere for a while -- and of course the FDA takes into account the experience that has been accumulated with those drugs. But often new drugs come up for approval first in the US -- so there is very little post-marketing experience.
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Bethesda, Md.:
So what happened to the FDA scientist who spoke with you without permission after the hearing? Might we find him in Guantanamo these days?
Andy Liebman: I'm as curious as you to find out. Hopefully administrators inside the agency will listen to what he has to say. But as of now there isn't any news.
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Ann Arbor, Mich.:
Great reporting. Mr. Liebman -- You cite the FDA's internal study about the extent of pressure reviewers feel. Pretty much the same excerpts are included in the Hilts book. Is the whole study itself available to the public anywhere? I believe the documentary said that Frontline "managed to get a copy" or something like that. Can we?
Thanks.
Andy Liebman: You should contact the FDA Office of Public Affairs and ask them for the study. If they don't give it to you, send a letter to me at Frontline.
I don't believe the study has ever been made public.
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New York, N.Y.:
Mr. Liebman:
Would you consider carrying your report one step further? FDA does not favor all pharmaceutical companies. On the contrary, they often are vindictive and arbitrary. Not all companies fall into the "Big Pharma" category. Many are small, privately held, upstart companies whose success relies on FDA fairly reviewing and without prejudice, product applications based on innovative technology. However, non publically held corporations whose stock cannot be purchased and/or firms for which FDA personnel would not consider obtaining a job from after retiring, are often held back and subjected to corrupt treatment. Especially when the innovative technology is a threat to "Big Pharma." Are you interested in speaking with a company that has been a victim of this treatment by the agency -- at the expense of public health? The agency, although necessary, has become corrupt! I can provide you with specifics.
Andy Liebman: I would be interested in speaking to you about this. One of the participants in our program told us that, while the FDA was too soft on big pharmaceutical companies in his opinion, the agency was often very tough on small companies that have less political clout. Send me a letter c/o Frontline, WGBH-TV, 125 Western Avenue, Boston, MA 02134.
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Cleveland, Ohio:
Comment:
In response to "Dangerous Prescriptions," there is the other scary side to the industry.
After I was wrapping up a six month pre-clinical study and preparing the report to submit to the FDA for a biotech company, my work, data and results were edited by my boss to be more appealing to the FDA -- i.e. exclusion of ALL animal deaths during the study.
After my cautioning against this (and knowing we were headed to conduct the same research in India although this time on humans), I was let go from the company's employment.
I understand and see that many more scientists like myself are "let go" after questioning safety data results before FDA submission.
So, you have industry on one hand effectively removing the truth behind studies BEFORE FDA SUBMISSION and you have the FDA removing/silencing safety advocate scientists DURING FDA APPROVAL PROCESS.
The product of both politics is "Hillenbrand Industries" share price increasing while good scientists learn to live "hand to mouth."
Andy Liebman: I don't know anything about the specifics of your story. If you want to send me a note c/o Frontline, WGBH TV, 125 Western Avenue, Boston, MA 02134 we can talk about it.
I can tell you that I have heard many similar stories from scientist friends in the Boston area. And it's even more frightening when the scientists involved work at universities on grants from drug companies and get asked to hide certain results. I have numerous examples from friends at top Ivy League institutions.
I am thinking about making a film on this subject, so please tell me your story.
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Providence, R.I.:
A portion of your discusion focused on the opinions of the reviewers and how they were accepted or not during the review process. Did you discuss the training and supervision processes with FDA management? One expects there to be supervisors and managers in most large organizations to provide oversight and secondary review. We do not have interns treating patients without supervision. Is there a process by which to confirm the proficiency of reviewers to a point where we can distinguish differences of scientific opinion, from management oversight of a bad review, from a tainted management overruling that your story seems to suggest?
Andy Liebman: It's not my place to determine what is a "difference of scientific opinion" from "oversight of a bad review" from "tainted management". Only an outside independent scientific investigation of the FDA could determine that, I'm afraid.
We did speak with the FDA management about countless individual cases and we were told the problem IN EVERY CASE was just a "difference of scientific opinion". I didn't believe this adequately explained why reviewers' concerns were consistently brushed aside.
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Durham, N.C.:
Excellent program. Anxiety producing and
compelling.
Did the FDA appear to be open and forthcoming
during your interview process, or was there
obvious uneasiness and apprehension?
Does the FDA routinely hire scientists from the
pharmaceutical industry, or more importantly, is
industry a potential and more lucrative employer
for FDA scientists?
Did you read “Dispensing With The Truth” by
Alicia Mundy? I thought it was an impressively
researched analysis of the fen-phen debacle -- all
the players -- the FDA, politicians, the industry, and
major medical institutions…came out looking
unsavory, to say the least, some more than others.
Andy Liebman: I would give the FDA a 50 % grade for cooperation. We requested interviews with the new head of the FDA, Mark McClellan, and with the head of the Drug Division (CDER) Janet Woodcock and we were turned down. We requested an interview with Dr. David Graham and we were turned down. We never received a reply to our Freedom of Information Act requests (made about 1 year ago now)
We were only allowed to spend about 2 hours filming in the safety division office. But obviously we did get in the door. And the agency got us a reasonable amount of information when we requested it.
To answer your second question, it is common for FDA employees to go work for industry after leaving the FDA. And vice versa -- the so-called "revolving door". It's an issue that affects all government regulatory agencies.
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Takoma Park, Md.:
I work for the EPA. We have a federally mandated list of studies that a chemical must go through depending on its TARGET use. Change the use, you have to do different studies.
It amazes me how different these agencies function considering how interrelated they are. But then again I am not suprised. THere are some chemicals in the USA that are regulated by the EPA and the FDA. THe difference between what we usually think of the toxicity of the SAME chemical is stunning.
Andy Liebman:
Why don't you contact me at Frontline to tell me about some of your examples. Andy Liebman c/o Frontline, WGBH-TV, 125 WEstern Avenue, Boston, MA 02134
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