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Podcast: What Should the FDA Do When Drug Tests Are Tainted?

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(The U.S. Food and Drug Administration/Flickr)

In an investigation published yesterday, Rob Garver and Charles Seife shared the story of how the Food and Drug Administration found a lab in Houston, Texas, that had provided the agency with drug tests tainted by "egregious" research misconduct. While the FDA's counterpart in Europe took seven of the improperly tested drugs off the market, the FDA did not follow suit.

Garver and Seife joined the podcast to discuss how the FDA typically handles situations like this, how the agency found out the tests were not conducted improperly, why the European Medicines Agency pulled the drugs, which drugs were involved, and why the FDA has not been forthcoming with more information.

"We certainly believe that the FDA ought to be more transparent, but it's not just us," said Garver. "Dr. David Kessler, the former head of the FDA, is on the record in the story concerned that the FDA hasn't been sufficiently transparent about this. He says that you can't just ask the public to trust you."

Seife added, "I think they (consumers) have to be worried about the process rather than any individual drug. The FDA is the watchdog — it is the agency that is supposed to keep us safe. And when it says that it can't tell us why these drugs are put on the market, despite the fact that we know that their experimental basis for the safety and efficacy of these drugs is undermined, [that] makes us question whether the FDA is hiding something."

Proposed remedies: 1. Remove the analytical company from all FDA rosters of reliable sources.  2. Publicly identify management and research scientists (carefully!!!) who either directly performed the research or had some management responsibility for approval of the data. 3. At the FDA, terminate anyone who approved acceptance of bad data, without mercy!

Anita Mitchell

April 16, 2013, 1:23 p.m.

Can we claw back FDA salaries since they have so egregiously failed?  What is different in Europe?  Well it could be they are more (but not entirely) socialized, government backed healthcare, and damage done to citizens is on the governments dime.  They do a better job over there, where their costs are lower, and their satisfaction is higher, and their outcomes better.  Our system is broken…polluted by money.  If we’re going to get this type of result, we might as well save where we can….on FDA salaries.

Re: ” how the agency found out the tests were not conducted “

I think you mean were conducted improperly.

This seems to be one more instance of the incestuous government/corporate revolving door policy. Which is to say, when you work in a government regulatory agency there is no incentive to crack down on the corporate interests you’re supposed to be monitoring, because when you leave public service (for greener pastures) you’ll be looking to go to work for one of those corporations.

That you are even posing the question is absolutely stunning and should shake the foundation of the FDA!!

Although there is always the Congress and their watchdog mentality of see nothing, mitigate, ignore, sequester, vacate, vascilate and move on!!

We need to rethink just what the FDA is doing if they are not protecting the American people, which is its job.  If they are accepting anything less than full disclosure on tainted drugs and does not rescind the right of any company that covers up bad test results to continue testing, then it is not protecting the public.

The FDA is corrupt beyond any repair. Shut down this agency.

I think Claude’s on the money.  If someone at a pharmaceutical company leaked unflattering data, what would happen to that whistleblower, absent any legal protection?

Why should a company falsifying data and endangering Americans be treated any less severely?

The FDA needs a complete over haul with real consumer interested parties running it and enforcing the laws which are now little to none. It seems like Elizabeth Warren should be appointed to head that commission to hire all new staff with policies that actually work. Many of these folks in these so called protection agencies are leftover appointees under the last administration and some from the Reagan days like the NLRB who are in the pockets of corporations. Any public official who was directly involved and complicit with the allowance of any tainted products should be charged appropriately for the crime that was caused. This is at least aiding and abetting in the allowance of people getting sick and or leading to their death.

I’ll relate another experience.

Some time ago, I was working on a project involving an investigational compound at a big name pharmaceutical company.  In the course of this work I had opportunity to discuss various aspects of the drug and its effects with co-workers.  One source related to me that management was in a flutter about some toxicity study results. 

It seems that in dogs at high doses the drug caused the hearts of the test animals to ‘liquefy’.  I was very surprised to hear this and it started me thinking.  On the basis of my prior work I proposed doing a series of experiments to investigate the cause of the liquified hearts.  At first management was receptive and gave me the go-ahead.  A short time later I was called into the office of one of my direct managers and told not to do the experiments.  I asked why and was told that the company did not want any ‘bad data’ written down anywhere about the drug. 

The company at that time had two of its’ big earners coming off-patent and they were counting on this drug to keep the lights on.  I escalated to the VP of research and the message was the same.

After overcoming the shock of this incident I resolved to finish the non-controversial part of my project and resigned.

It turns out that the drug was taken forward into human studies and that the drug caused excess mortality in certain demographics.  The company was acquired twice in quick succession and the drug was eventually dropped.

Regarding Rob’s comment: What you describe is common, especially in the USA but also abroad.
Pharma corps are able to easily NOT report adverse results by simply “disappearing” the studies. Regulators, medical professionals, and the public get only the rosiest of results.

There is a petition online gathering signatures to make all trials public, and medical professionals giving convincing presentations on the topic to groups here and abroad.

Here’s the URL:  http://www.alltrials.net/

“It is no measure of health to be well adjusted to a profoundly sick society.”

Dumb Q, when you consider the FDA is a totally corrupted org.

Well, of course, you have to reject the application for approval but, even a correctly run testing procedure has been shown to be useless and The FDA should not exist

Merck, Vioxx and admit no wrong doing. I’d tell my story but nobody cares. Admit no wrong doing has infiltrated everything.

arnold kleinmd

April 19, 2013, 6:24 a.m.

Recently a patient came to see me after being treated with Botox®. She could only open one eye and could barely smile. She looked more like she had a stroke than an aesthetic treatment. I called the physician who treated this woman, and found that he had used a unusually large volume of diluted Botox®. When I told him his dilution was far too large he says he had read dilution of Botox® did not matter. I told him this article was incorrect and the large volume of fluid he used caused the toxin to reach unintended muscles.
This type of incorrect information has turned present day medical literature into something akin to a mystery novel. Every time I pick up a medical journal I wonder if what I read is accurate or just a sales pitch from pharmaceutical companies, aka Big Pharma.
I often wonder why there are not legions of Physicians at my side, standing up to Big Pharma. This is same feeling I had when the American Foundation for Aids Research was founded at my home in 1984. Why can’t the others see the sky is really falling?
I guess maybe it is because my work is a lot more than a job to me. It’s my life; my passion; my everything and it has been that way since I first got interested in medicine.
      There are many responsible forces in my life that led me to pioneer the field of minimally invasive aesthetics. I realized the value of skin’s beauty at a very early age, as I was severely burned as a child. The damage caused me to avoid wearing short sleeve shirts until I was 21 years old. The burn also opened my eyes to visual aesthetics, as I began to envision and appreciate various forms of beauty. In the 1960s, I developed a love of the visual arts under the influence of such individuals as Andy Warhol and Louie Kahn. Interestingly enough, Louie Kahn had a severe facial burn.
    When I came to California for my internship in 1971, I began to meet an amazing group of artists that deeply influenced me and the way I saw things, including the human face. My California mentors include John Baldessari, Frank Gehry, Robert Graham, Ed Ruscha Ed Moses, and many more, who are legends of our time.
    One of these artists suggested I read Neuropolitics by Timothy Leary, which discussed the western migration of creative people. I definitely experienced the magnetic pull of creativity and light of the west. Although, I spent one year in dermatology residency back at Pennsylvania under the great Dr. Albert Kligman, I convinced him I needed to return to the land of light—-California. Thus began the marriage of art and science, of east and west, as I completed my dermatology residency at the University of California at Los Angeles.
De. Norman Orientrich, influenced my scientific perspective on injectables. He was a great champion of injectable silicone. However, to my eyes, the appearance of his nurses who had been treated with injectable silicone did not look natural.
I liked the idea of enhancing a face with injectables, but I wanted the result not to appear artificial. In 1979, my world forever changed when I developed the injection technique for bovine collagen. I wanted to share my experience with others, but the American Academy of Dermatology (AAD) holds meetings whose speakers are chosen by political position rather than by merit. I had received a call from a prominent San Francisco Dermatologist asking if I would get the word “skin” in the new arm of the National Institute of Health (NIH). NIH is the United State’s government agency for medical research. This required working with Congressman Henry Waxman, as unfortunately, the AAD had been unable to do so. I contacted many people, but only after speaking to the late great Lou Wasserman was I able to meet with Congressman Waxman…and within a few days. Due to Congressman Waxman and my collaboration, “Skin” was in the title of the new NIH center. It was then that I requested and received a course at the AAD to speak on injectables. My course attendance size became larger and larger, and I was very excited to witness the evolution of my world of minimally invasive aesthetics.
    I remember developing lip enhancement in 1984, and how it shook my small universe when I created Goldie Hawn’s extreme lips for the movie “The First Wives’ Club.” Granted, these were medically controlled distortions of injectable aesthetics, but made a great impact. Then something unusual occurred. Along came an immensely novel product called Botox®. I was the physician who developed the dilution and injection sites used for Botox’s® FDA approval for cosmetic purposes, and I became a major proponent of the drug’s usage. However, I had no idea that lurking behind this drug was a pharmaceutical company, who used cooperative physicians to willingly supported whatever the company told them. This corruption turned my dream into a bureaucratic nightmare.This situation is understandable, as minimally invasive aesthetics is one of the few remaining areas in the medical field where money can be made. As the rules go, once money is involved, it gives birth to greed. After greed comes dishonesty. What these forces created in medicine is a tale worse than anything that Steven King might have dreamt up.
It is a story of the FDA, medical societies, physicians, and most importantly, pharmaceutical companies that created a beast. This cast of characters is so intertwined; it is most difficult to see where one begins and the other ends. The beast includes forged medical literature, unlicensed foreign physicians selling products to the American public, misleading education of the medical community, and the approval of potentially disfiguring agents that are no longer available anywhere but the United States. The damage inflicted from this monster may appear at first possible, but is quite real, including severe scarring and even death. How on earth in our world of American medicine did this happen?
\While fillers restore volume and Botox® erases lines caused by muscle motion, the field of minimally invasive aesthetics has exploded into the mass market where the scalpel was once king. For medically trained individuals to properly utilize injectable agents such as Botox® and Restylane®, they must understand both where to inject the drugs, as well as understand the behavior of the drugs once injected.
    Why is there such an interest in injectables? The use of Botox® for cosmetic indications made it increasing acceptable for individuals to undergo cosmetic procedures. The FDA has been unable to control the nation’s obsession with cosmetic drugs while Big Pharma fuels the frenzy through spokespeople and media advertisements. Information to the public does not indicate the true risks associated with minimally invasive aesthetics.
    Soon after the approval, the physician spokespersons endorsing the various usage of Botox® were foreign physicians, who were not licensed in the United States. These physician spokespersons frequently took credit for publications they did not author, and publicly injected Botox® throughout the U.S. without licenses. No one questioned their lack of licensure.
    Next, aesthetic centers began to appear on every street corner. The aesthetic centers assured the public that these injectables involve simple “in and out” procedures which were easily performed by anyone. To the contrary, injecting minimally invasive aesthetics is not a simple treatment, but requires significant scientific understanding and skill in administering. These prescription injectable pharmaceuticals should not be performed at the mall or in the back room of a beauty parlor by untrained individuals ... including physicians. Training in this field is not a weekend course given by the manufacturer, but occurs over time as one becomes more familiar with the behavior of these agents. The pharmaceutical companies further compound the problem by marketing to physicians in every field to increase sales.
    The real beasts in this arena are centrally located in Washington DC, where politics and money are truly changing the face of America. When pharmaceutical companies began to pay physicians, including me, large sums of money to teach, study and increase the sales of their products, a monstrous form of greed began to grow. It resulted in a large group of aesthetic physicians who willingly promote almost any agent ... provided they are compensated. In 2013, these politically savvy physicians run medical societies, edit trade publications, appear on the internet and television, are quoted in beauty magazines, and speak before the FDA. Try to tell the truth in Elle, Vogue Allure, W or any other woman’s magazine and you will find your quotes in the circular file. The Editors seem to be more interested in their advertising budget than their reader’s welfare.
As stated, in 1997, I developed the injection pattern and dilution of Botox®, which was subsequently used for clinical trials which resulted in the FDA cosmetic approval of Botox® used for the frown. I specifically chose a small dilution for the FDA indication because large dilutions may result in the unintended spread of the toxin to muscles you do not want to relax. For example,a little water on the floor of your powder room will be limited to that site while a large flood or volume of liquid on the floor of the powder room could create a flood and ruin the carpet in your living room. It has long been known that large dilutions of botulinum toxin (Botox®) could result in the toxin migrating and reaching unintended muscles. Past U.S. Food & Drug Administration studies have found that problems with dilution or volume injected were the greatest cause of adverse reaction with Botox®.
    In 2007, an article published by a Canadian dermatologist as lead author concluded that dilution of Botox® was unimportant. A few years prior, an attempt was made by this same Canadian physician, the Aesthetic Czar of Allergan, to publish this same article. However, a review of the submitted paper uncovered serious problems and contradictory data, suggesting worse wrinkles after the Botox® wore-off then prior to treatment . Furthermore, small sample sizes and adverse events in the larger dilution groups were noted. In light of these concerns, the article was rejected for publication. The authors then resubmitted the article to the same journal but removed the data which had shown that wrinkles worsened after the toxin wore off. I spoke to the editor of the journal, and he promised to address the problem with the authors. I was both shocked and appalled to see the article appear with the altered data in the January 2007 issue of the medical journal.
      As Allergan, the manufacturer of Botox®, continues to teach anyone who can hold a needle how to inject this potentially toxic substance, the number of adverse reactions are expected to increase as injectors no longer had to worry about proper dilution. Indeed, profit has replaced patient safety as the major theme of Continuing Medical Education (CME) courses, thus setting the stage for potential medical disasters. Often inaccurate or altered medical data is used to reach dangerous conclusions.
    Dr. Scott S. Reuben’s faked data for 21 studies involving Vioxx®, Celebrex®, and other drugs and it caused a ruckus in the medical world. Forged data being released by a physician or physicians with strong ties to the Pharmaceutical Industry (as noted above) is commonplace. In another article in the same January 2007 issue of the Journal the very same foreign physician who submitted the Botox® dilution conclusions attempted to include my name and another physician’s on an article regarding the supposed safety of the injectable type B toxin, Myobloc®. We both demanded our names be removed. We were then offered $10,000.00 by the company who manufactures Myobloc® to include our names on this paper. We both voiced concerns that this article was incomplete, and did not reflect the true toxicity of this agent as had been shown in other studies, especially studies from Japan . In clinical usage, this toxin had been known to cause distant side effects such as inability to swallow when used in normal doses. Our names were removed from the article, but the manufacturer refused to include this important safety data. The article concluded that this toxin was both safe and effective. In the U.S. Myobloc® is approved for the treatment of adults with cervical dystonia, but is used off-label for a myriad of other indications. Physicians such as Dr. Reuben (and the Canadian dermatologist noted above) are supported by America’s biggest pharmaceutical companies. Pharmaceutical Companies are the people who control medicine

The field of aesthetics has been badly damaged by these deliberate acts. I have voiced my serious concerns and raised questions about the alteration of data published in peer-reviewed journals. As a result, I have been terminated from two manufacturer’s advisory boards and from the editorial boards of the three major peer-reviewed dermatology journal publications. Somehow and in some way, we must warn the public of the potential danger that exists at the end of the needle. Don’t these people know to lie is a liability? Once again the sky is falling but it is much more serious now. And to My Dear President Obama; only through repair of a badly damaged FDA can you begin to repair medical care in the USA.

Arnold W. Klein, MD
ProfessorMedicine/ Dermatology
UCLA
Klein Chair UCLA
Retired Prof.Dermatology Stanford
Visiting Prof Dermatology Harvard
Consultant-Surgical Device Panel of the FDA

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