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July 21st, 2010
01:44 PM ET

FDA freezes long-term study on diabetes drug

A long-term study on the safety of a popular diabetes drug was put on hold Wednesday by the Food and Drug Administration, while the FDA considers whether it’s too dangerous to continue.  Several large studies have linked the drug, Avandia, to a higher risk of heart attacks and other heart problems. While other studies have not found the same risk,  last week an FDA advisory panel recommended that the drug not be sold without a stronger warning label or  possibly limits on who could receive it.

The so-called TIDE trial was ordered by the FDA in 2007, after the first major study suggesting a link to heart trouble. It's designed to compare Avandia with Actos, a similar medication.  The study was the subject of impassioned argument at the two-day meeting last week. A prominent FDA official, Dr. David Graham, said it should be stopped because there was no true benefit to participants and that it amounted to "human exploitation."

"It's a study to establish harm," Graham told the panel. "If the purpose of a study is to establish harm, it's unethical right off the bat. You can do that to laboratory animals, but not to human beings."

Dr. Hertzel Gerstein, the lead investigator of TIDE study, defended the study, saying, “The protocol has been independently reviewed by hundreds of ethics committees around the world.”

The FDA panel voted, 20-10, to recommend that the TIDE study continue.

GlaxoSmithKline (GSK), the company that sells Avandia, was supposed to recruit 16,000 patients for the TIDE study, but recruitment has been slower than expected. So far just 1,324 have signed up, spread around 353 medical centers in 23 countries, according to GSK spokeswoman Mary Anne Rhyne. Wednesday's decision allows patients already enrolled to continue in the study, but directs investigators to review the safety issues and what information they provide to patients.

"This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee’s recommendations,” GSK's chief medical officer Dr. Ellen Strahlman said in a statement.

The FDA is still weighing whether to take the panel's advice on a stronger warning label and tighter restrictions, and whether to go even further and pull the drug off the market. A spokeswoman said the TIDE decision was not a signal that the agency is leaning one way or another on those decisions.


soundoff (24 Responses)
  1. Philip

    I guess you can argue that the study is designed to establish harm, but doesn't that also mean it is establishing safety? How can you stop a study because you know it's harmful, but at the same time still allow the drug on the market? 10 years from now we'll be flooded with commercials asking us to join class-action lawsuits after this drug is eventually pulled. C'mon FDA, get your act together.

    July 21, 2010 at 16:10 | Report abuse | Reply
    • Donald

      There is increase risk for heart diease in diabetes. So the question is does heart diease occur at a increased rate with Avandia or is heart diease rate higher in a untreated diabetic patient? Everything boils down to risk versus benefit when treating patients.

      July 21, 2010 at 17:07 | Report abuse |
    • Philip

      I just take issue with them stopping a long term study of a drug that is clearly dangerous (How dangerous it really is can be debated, but it's dangerous enough to have this much attention) stopped for reasons that seem suspect. At this stage, the only people taking this drug are the people who would be prescribed the drug. This is not a stage I or II clinical trial. By stopping this study, the only person that wins is GlaxoSmithKline.

      July 21, 2010 at 17:09 | Report abuse |
    • JoT

      "By stopping this study, the only person that wins is GlaxoSmithKline"

      I would argue that stopping the trial also benefits Steve Nissen and the FDA's Graham. Their reputations hang in the balance. If the trial were to proceed and the results were to show no harm, both of these individuals would be scraping egg off their faces for years.

      July 22, 2010 at 10:41 | Report abuse |
    • Joe

      Everything boils down to encouraging farmers and food producers to product natural foods rather then foods laden with chemicals and additives. I will be you that the food industry and the big pharma are in collusion.

      July 22, 2010 at 16:41 | Report abuse |
  2. JPT

    Once again, big government stepping in to keep people from getting killed from medicine... If this the 1890's, we wouldn't have these problems!

    July 21, 2010 at 17:02 | Report abuse | Reply
    • Philip

      This is a case of the government saying the drug is too dangerous for the study, but not too dangerous to pull. It's a hypocritical move, and I wouldn't be surprised to hear that the actual reason the study was put on hold is more of a political and financial motive.

      July 21, 2010 at 17:12 | Report abuse |
  3. Mariska

    This stuff was on the market for 10 years before the FDA yanked it...... Aren't drug companies supposed to conduct studies so this kind of thing doesn't happen?

    July 21, 2010 at 17:50 | Report abuse | Reply
  4. gjc

    The actual degree to which Avandia is dangerous has noty been established by a primary study, but has been inferred by metaanalysis. Unfortunately, the initial metaanalyssis was so flawed as to raise real question of its purpose. Further, the author was paid by the manufacturer of a competing drug to perform the metaanalysis.

    The issue here is similar to the selective COX-2 studies where individual agents were suspected of being harmful, but where, in effect, the whole class of drug was finally found to be dangerous. The problems reside in the concepts of metaanalysis in place of competent formal studies to determine safety and efficacy, and metaanalysis has become a key to "evidence-based medicine". In general, these metaanalysis studies are commissioned by a drug company to "demonstrate" safety/efficacy of their drug, or conversely, the lack of safety/efficacy of a competetor's product. When I trained, you didn't attempt to lie through statistics where human lives were concerned. Instead, you constructed the best clinical trials possible, and obtained formal conclusions that could be verified by another clinical trial.

    July 21, 2010 at 18:28 | Report abuse | Reply
    • Joe

      Would you take this or give it to your dog?

      July 22, 2010 at 16:42 | Report abuse |
  5. almxx

    They must not stop this drug. Look at the billions of dollars that could possibly be made for the pharma companies. Just put a giant label BUYER BEWARE, THIS DRUG MIGHT CAUSE DEATH. Let the informed consumer decide. It is the American way.

    July 21, 2010 at 18:29 | Report abuse | Reply
    • Reply to almxx

      And when it is so blatantly obvious that nobody gets along with this drug (end of product life cycle), have it declared an environmental hazard and remove it from market. Works for them.

      July 21, 2010 at 19:01 | Report abuse |
    • Joe

      Telling people that a drug will kill them even on the label won't stop them look at smokes nobody stops that.

      July 22, 2010 at 16:43 | Report abuse |
  6. Joani

    It seems to me the FDA is messing up a lot lately! Food and drugs! 2 of the most important things in our lives.

    July 21, 2010 at 20:43 | Report abuse | Reply
  7. joe

    only when a drug works does the government pull it i know of vitiams that where outlawed in last few years gov pulled them from shelfs because thay where curing cancer cant have that government needs people to be sick so thay get money for drugs that done work government in america is soo currupt

    July 22, 2010 at 08:34 | Report abuse | Reply
    • Nic

      Are you a real person? Do you know how many billions of dollars a year the government spends on sick people, especially the chronically ill in the cases of obesity, heart disease, diabetes? The government LOSES money with a sick populace because the society loses productivity, the healthy people and the government have to find ways to support this group of people that are chronically ill and unable to provide as much to society as healthy people. Add to that the fact that chronic illnesses cost society a lot financially and many of those who are ill cannot meet the financial burdens of their illness without the support of the healthy via private insurance or the government via medicaid and medicare.

      July 22, 2010 at 13:02 | Report abuse |
  8. Kelly

    There are natural ways to help ourselves and maybe more people should investigate that route, especially when we hear news like this. Advanced blood sugar solution is a supplement I am aware of that helps.

    July 22, 2010 at 12:52 | Report abuse | Reply
  9. KR

    they should also test these drugs against herbal remedies- most Herbals might not work as fast, but have manyfewer side effets- why dont they add them to the studies??- because Big Pharm dosnt want it??????

    July 22, 2010 at 13:13 | Report abuse | Reply
    • Joe

      You know why drug companies don't like herbal remedies, profit and the fact that herbal remedies cannot be patented.

      July 22, 2010 at 16:36 | Report abuse |
  10. Karen

    My biggest problem with this article is the statement "It's a study to establish harm," Graham told the panel. "If the purpose of a study is to establish harm, it's unethical right off the bat. You can do that to laboratory animals, but not to human beings." Why should it be ok to put the lives of animals in danger for the good of Human Beings? Overall these drugs are not helping us at all instead making us sicker and more dependent on them.

    July 22, 2010 at 14:51 | Report abuse | Reply
  11. Joe

    Please, the only reason the FDA did that is because people found out about the side effects ahead of time and the drug companies would of made the trillions of dollars they needed before recalling it anyway and they wouldn't of had enough money for all the class action lawsuits that would of followed. Notice how it is ok for a DRUG company to give you your first full prescription for free but you can't do that for pot.

    July 22, 2010 at 16:35 | Report abuse | Reply
  12. Joe

    If food companies didn't put crap in our food we wouldn't need these drugs in the future. These drugs always have far more side effects then good effects they are poison even when they do help they lead to new drugs being needed. Where do you think all the street drugs came from rouge chemists in drug companies.

    July 22, 2010 at 16:39 | Report abuse | Reply
  13. MR

    What do you guys say now after the french study? They could stop the US study but they had no control over this one, and the bad news came out.

    June 21, 2011 at 15:55 | Report abuse | Reply
  14. MR

    p.s. And even with the French study, the FDA hasn't recalled or restricted Actos! http://bit.ly/lz0vW5

    June 21, 2011 at 15:56 | Report abuse | Reply

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