July 9th, 2010
11:47 AM ET

FDA pokes holes in study defending Avandia

The Food and Drug Administration this morning posted a blistering analysis of a study on the popular diabetes drug Avandia, a study the drug’s maker has pointed to repeatedly as evidence that Avandia is safe. The study, known as RECORD, involved more than 4,447 patients and compared Avandia with two older diabetes drugs, metformin and sulfonylurea, and found no increased risk of heart problems. But the analysis by Dr. Thomas Marciniak says researchers repeatedly submitted sloppy data and failed to follow up on reports of problems in patients – including reports of patient deaths. He also called the design of the study “inappropriate and biased.” The end result was to provide a more favorable picture of Avandia than the data warrant, according to Marciniak.

His analysis was submitted last month to an FDA panel that next week will debate the fate of Avandia, which other studies have linked to an increased risk of heart attacks, stroke and heart failure. It was posted today by the FDA, along with other materials the panel will consider during its meeting next week.

In a statement Thursday, Glaxo’s vice president for Clinical Development, Dr. Murray Stewart, said, “Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.”

The RECORD study is the largest of those, and the most widely known. In a briefing Thursday, Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said, “RECORD is the most germane because it is meant to look at cardiological comparisons between rosiglitazone [the generic name for Avandia] and the standard of care.”

Visit CNNHealth.com later today for more details.

soundoff (30 Responses)
  1. PiercedPsycho

    Leah, lay off the crack and comment on the article, not on your crackpot conspiracy theory. There is a place for everything.

    July 9, 2010 at 12:35 | Report abuse | Reply
  2. PiercedPsycho

    Back to the topic at hand...am I correct in stating that GlaxoSmithKline is the maker of Avandia? It was never directly stated, and I was a little confused by the phrase "In a statement Thursday, Glaxo’s vice president for Clinical Development"

    July 9, 2010 at 12:40 | Report abuse | Reply
  3. mark

    You mean to tell me that a large drug corporation is lying and faking reports to help sell its poison? I am shocked. If any one missed it, that was sarcasm.

    July 9, 2010 at 13:53 | Report abuse | Reply
  4. ranch111

    Junk can't cure the junk you put in your body.

    July 9, 2010 at 14:24 | Report abuse | Reply
    • Katie

      Well said. I shifted from junk to health food a month ago and I feel so much better already. A lot of my health problems are starting to aleviate themselves, and I am losing weight in the process. If we really start eating healthy, we get less trips to the doctor, meaning less meds, meaning expectations of lower insurance premiums. If this country went total health, it would turn the medical money making machine on its head. Good post.

      July 9, 2010 at 16:02 | Report abuse |
    • Katie

      Well said. I shifted from junk to health food a month ago and I feel so much better already. A lot of my health problems are starting to aleviate themselves, and I am losing weight in the process. I

      July 9, 2010 at 16:03 | Report abuse |
    • Dr. Greg

      Very well put.

      July 9, 2010 at 16:26 | Report abuse |
  5. rhonda reinier

    Type I & Type 2 Diabetes is BIG BUSINESS

    July 9, 2010 at 14:38 | Report abuse | Reply
  6. Lzzrdking2

    People are going to think that this means the system doesn't work.... but this is EXACTLY why there are multiple studies done on these things and everything needs to be reproducible. This should increase peoples faith that we are actually studying these things but I am sure people will just see it as another reason to turn to magic instead of real medicine...

    July 9, 2010 at 14:44 | Report abuse | Reply
  7. Gary

    "You mean to tell me that a large drug corporation is lying and faking reports to help sell its poison? " And the government is not beyond doing so? I do not know the facts, but what if this is a better, but more expensive drug/ The government will not want it being used, as it will raise the cost of treatment. Just something to think about.

    July 9, 2010 at 14:53 | Report abuse | Reply
    • Carl

      Actually, it probably would not raise expenses when compared to the costs of treating poorly maintained diabetes. Why do so many people think the government/FDA has some evil purpose in mind? I'd be far more concerned about drug companies looking at huge profits from these so-called miracle drugs and pushing them for adoption before all the studies are done.

      July 9, 2010 at 15:03 | Report abuse |
  8. Gary

    @ranch111, I agree about Type II, but what about Type I. There is nothing they can do, in reality same goes for most cases of Type II. Some of it is brought on by weight, but some is heriditary.

    July 9, 2010 at 14:55 | Report abuse | Reply
    • Heather

      As a healthcare provider, please show me a patient with type II diabetes that is solely due to heredity. Somehow, all of my patients with "hereditary" type II diabetes are obese just like all my other obese type II diabetics. You can't blame Mommy and Daddy for everything. The answer to the type II diabetes epidemic is to push yourself back from the table and keep moving until you're outside walking around the block. Alas, too many of my type II diabetics fail to heed this advice and blame "heredity."

      July 9, 2010 at 19:07 | Report abuse |
    • Karina

      Gary, actually you are wrong. Type two diabetes is not hereditary. The only thing genetic could be the lazy and self indulgence. jk. Seriously, I work with diabetics and all type two can be reversed with exercise and healthy eating like almost RAW and vegan diets. Check out the documentary "Simply Raw".

      July 9, 2010 at 19:21 | Report abuse |
  9. Roy J

    Everything you put into your body has some effect. If you are stupid enough to blindly trust your doctor, your pharmaceutical company, your government, your employer, your insurance company, your neighbor, etc then you deserve what happens to you. Be smart, reseach things on your own (/sarcasm on ... of course use the interwebs cuz they never lie! ... /sarcasm off) and make educated decisions. At that point you can remove most of the blame from yourself.

    Have a great weekend!
    There are only 10 types of people in the world, those that understand binary and those that do not.

    July 9, 2010 at 15:03 | Report abuse | Reply
  10. duffey

    Physicans must have good information regarding the potential side effects of medication so they can weigh the the benefits vs. the risks. However fatal flaw is often tiems the MD is not up todate on the side effects, and if they they are aware of teh downside to the medication there may not be full discloser is not given to the patient.

    This is really a cause and effect. The Providers are seeing too many patients to have down time to do the necessary reading or are not with the patient in front of them, but thinking about the next 3 patients they msut see.

    July 9, 2010 at 15:31 | Report abuse | Reply
  11. Marc

    There have been numerous studies that have questioned the safety of Avandia. My father has diabetes, and U have been tracking these studies. GlaxcoSmithKline, which produces Avandia, paid for the study that is usually cited as proof that Avandia is safe. Glaxo also markets heavily to physicians to get the doctors to prescribe Avandia to their patients. Simply stated, the government would not be taking second look at the issue unless the newer studies that questioned Avadia's safety had some merit. I spent a lot of time researching all this, and I took my father off Avandia and had him put on an alternate medication that seems to be doing just as well. And because it's beyond its patent period, he can get a much cheaper generic.

    July 9, 2010 at 16:11 | Report abuse | Reply
    • PiercedPsycho

      Marc-so Merck doesn't market to doctors? All pharms market heavily to doctors. My father used to work for GSK as a drug rep-ALL pharmas do it. All pharmas take doctors to lunch to try and get them to prescribe THEIR diabetic med, THEIR anti-depressant, THEIR nasal spray.

      You want to know who knows the most about a drug, after the researchers who make it? Drug reps, because they have to sell the drug to doctors. They must know the drug backwards and forwards.

      July 10, 2010 at 10:21 | Report abuse |
  12. Allison

    It should be illegal for prescription drug companies to advertise to the public- with the more power they have they can lobby harder to get drugs passed through- at the patient's expense of thier health. We can't advertise for cigarettes because they are dangerous, so why should we allow these companies to advertise drugs that are by presciption only and harmful? Leave the reccomendations to your doctor, and take the pill popping, money making control away from these vampires!

    Sometimes the side effects are worse than the benefit, and some of these drugs would be unessisary if we as americans could control our diet and exercise. *sigh*

    July 9, 2010 at 16:23 | Report abuse | Reply
    • Claire

      I agree that prescription drugs should not be advertised to the general population. And I couldn't find my insect-bite creme, so I grabbed some cheap witchhazel from the medicine cabinet. I was amazed that it worked as well or better than the expensive concoctions. But no one is making money, so it's just not advertised.

      On diabetes, lifestyle definitely makes a difference, and humans were not meant to sit in offices. It's not easy to get in all the aerobic exercise and healthy foods to really make a difference. We've made it hard to stay fit as a culture. It's not individual shortcomings–it's an entire culture that has found cheap, quick, but unhealthy ways to feed our people, placed them in long commutes and given them long workdays so they are even less likely to strike out as individuals for fitness.

      We really need to reexamine everything we are doing as a culture instead of mocking fat people, blaming individuals, etc. And one key area for improvement is the silver bullet mentality. We tell people via advertising and medical professionals that a pill is a cure-all, and it almost never is.

      July 9, 2010 at 17:55 | Report abuse |
  13. ed

    as long as there is money to made by creating and selling medication there will be companies that try to hide the harmful side effects in the name of making money.

    July 9, 2010 at 16:40 | Report abuse | Reply
  14. John

    So what's new. Drug companies routinely do their own studies and say their drugs are safe when a huge amount of them are not safe. Just look at the number of stories where drugs are recalled after a few years of being on the market because it was decided that there were more problems than they were helping. And most of these are by the large pharmeceutical companies who make huge profits while causing an untold amount of damage. They need to outlaw the marketing of these drugs on TV and radio as well. It doesn't make sense that they are reaching people who then ask their doctors for those drugs whether or not they would be right for them.

    July 9, 2010 at 16:43 | Report abuse | Reply
  15. Star

    I'm ashamed to say that as an employee of Glaxosmithkline, I was involved with the Avandia clinical trials. I, and many of my co-workers, studied data reported from these trials and it became clear that there were possible serious, life threatening cardiac side effects. I agree with Dr. Thomas Marciniak, the study was “inappropriate and biased.” The data submitted by researchers was sloppy, and in my opinion, even manipulated, to provide a more favorable picture of Avandia. Competition among drug companys is fierce, it is a business, and whoever comes out on top stands to make billions of dollars.

    July 9, 2010 at 17:30 | Report abuse | Reply
  16. Claire

    A close relative is on another diabetes study drug, and has communicated to me that the companies have never even asked about side effects during the studies in which he participated. They look at their blood and urine and EKG results and have never so much as offered a questionnaire about side effects, and he's been in various studies for about 5 years.

    July 9, 2010 at 17:39 | Report abuse | Reply
  17. Phil

    it's all about the money!

    July 9, 2010 at 17:41 | Report abuse | Reply
  18. DrAly

    This has been followed by physicians over the past several years, and I don't personally know anyone who is still prescribing Avandia as a new or add-on drug for patients with diabetes. I personally would not use it currently, given that we have other oral drugs, plus insulin, that we can use. Also, as others have mentioned, lifestyle modification is key, and weight loss (in the case of Type II DM). However, many patients will not lose weight...it is very discouraging. I'm sure it is hard for many, but I feel like if I had a life threatening disease and a physician or nurse told me that weight loss would help, I could lose at least 5-10lbs. Research has showed that losing 5% of one's body weight can make a significant impact on Type II DM. But I digress...
    As far as Avandia goes, there is certainly a contraindication to using it in patients with known heart failure or cardiovascular disease. I would not personally use it even in people who don't...I suppose there are always exceptions to the rule, but I can't think of a situation where I would use it. I would say that the weight of the scientific evidence right now certainly points to Avandia raising the risk of cardiovascular events. There are other drugs with a similar mechanism of action that appear to be neutral, or even beneficial, in regards to risk of cardiovascular events. I do not think that this one episode/discovery should sour one on using conventional medicine or controlling one's diabetes, as it has unequivocally been shown that out of control/high blood glucose is also linked to increased risk of health problems if you are diabetic. No doctor (at least none that I know) is interested in "pushing pills" on a patient...we only want to lower the patient's risk of bad complications such as heart attack, stroke, kidney failure, infections, etc. in the setting of diabetes.

    July 9, 2010 at 17:54 | Report abuse | Reply
  19. Victoria

    The medical system is completly flawed, not just in US. There is an emphasis on the chemical side of an illness. You can't just expect that taking a drug while continuing to to abuse your body will cure you illness. At the same time, you can't expect the body is made just of chemical processes. There is more than meets the eye.

    July 9, 2010 at 18:04 | Report abuse | Reply
  20. sofrito

    It remains a mystery to me why the FDA allows the maker of a drug to conduct the safety tests on its own drugs that will be used by the FDA to approve it. For the vast majority of drugs Americans are prescribed today, the studies showing what a great drug it is were all conducted by the manufacturer. Has anybody in that entire organization every heard the words "conflict of interest?" I guess not.

    July 9, 2010 at 18:05 | Report abuse | Reply
  21. E

    There are a couple of easy ways for EVERYONE to avoid Type II Diabetes.

    3) AVOID MSG
    4) EXERCISE.

    If people got in regular habits of reading labels and took responsibility for their own health, this country would not have half of the chronic degenerative WESTERN diseases it has. Don't wait for your doctor to put you on meds. Find out what causes these illnesses and do the opposite. The great part of Type II is that it's completely reversible. Take responsibility, lose some weight, make better choices, and increase your quality of life. Water is cheaper than Coke anyway, so not only will you save on your grocery bill, but you'll avoid costly prescriptions and trips to the doc. It's a win-win.

    July 12, 2010 at 19:33 | Report abuse | Reply
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