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September 23rd, 2010
11:34 AM ET

Diabetes drug Avandia restricted by FDA

The controversial diabetes drug Avandia will stay on the market, but the U.S. Food and Drug Administration restricted its use to patients with type 2 diabetes who cannot control their illness with other medications.

The restrictions are based on studies showing an increased risk of serious heart problems, including heart attacks and strokes, in patients taking Avandia, the FDA said Thursday.

Just minutes after the FDA posted its decision on its website, its European counterpart, the European Medicines Agency, announced that it’s going further and suspending approval for the marketing of Avandia in Europe. If the decision is finalized by the European Commission, the drug will be removed from the European market, along with two medications Avandamet and Avandaryl that combine Avandia’s active ingredient with other drugs. Dr. Hans-Georg Eichler, the agency’s senior medical officer, said he expects a final decision within “a few weeks.”

The FDA’s move runs counter to the recommendation of a senior scientist, Dr. Gerald Dal Pan, who advised the agency to pull Avandia from the market altogether. Dal Pan heads the FDA’s Office of Surveillance and Epidemiology, which oversees the safety of drugs that have previously been approved.

In explaining her decision, FDA Commissioner Margaret Hamburg said the agency “is taking this action today to protect patients, after a careful effort to weigh benefits and risks. We are seeking to strike the right balance to support clinical care.” Approximately 600,000 Americans take Avandia, and those patients may continue taking the drug, Hamburg said, “if they are benefitting and they acknowledge that they understand the risks. Doctors will have to attest to patients’ eligibility.”

Avandia is used to control blood sugar in type 2 diabetics. It was approved by the FDA in 1999 and by 2006 was widely prescribed, with sales of more than $3 billion in 2006. But the drug came under close scrutiny in 2007, when Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, published an analysis which showed a 43 percent increase in heart attacks for patients on Avandia. The finding led the FDA to order GlaxoSmithKline (GSK), the drug’s maker, to conduct a thorough study of its safety. The full results of that study – known as RECORD – were made public last year. While GSK said the safety data was reassuring, the study came in for blistering criticism at a July meeting of an FDA advisory committee, where Dr. Thomas Marciniak, an FDA scientist who reviewed the data, said GSK ignored several cases of patients who suffered severe adverse effects.

In June, another FDA scientist, Dr. David Graham, published an analysis which came to similar conclusions as Nissen had. The accumulation of negative findings led the advisory panel to recommend a clampdown on use of Avandia, although the panel’s vote was split, with 17 in favor of restrictions, while 12 members voted to pull it from the market entirely and three said no action was needed.

On Thursday, the FDA ordered GSK to develop a program to ensure that access to Avandia is tightly controlled. It also ordered the company to pay for an independent review of the RECORD study, and ordered a stop to another study comparing Avandia with Actos, a competitor’s drug.

Nissen, the Cleveland cardiologist who became the drug’s most well-known critic, sounded a mixed note after hearing of the decisions. “It’s taken too long to stop the use of a drug that clearly was harming people. We’ve got to fix this system.” At the same time, he said he’s satisfied with the FDA and European moves. “The use of Avandia and related products will essentially cease in the U.S. and Europe. I will anticipate that 99 percent of the use of this drug will cease worldwide.”

Others who have studied Avandia were more critical. Dr. John Santa of Consumer Reports Health called the FDA’s failure to withdraw the drug, disappointing. “It’s frustrating for us to see there are still several hundred thousand patients on this,” Santa said. “We have concerns that many of those people don’t realize there are other alternatives that are more effective and less risky.”

Paul Thacker, who as an investigator for Senator Charles Grassley (R-Iowa) and the Senate Finance Committee accused GSK of burying negative information about Avandia, said the FDA is being too timid. “When you look at all the evidence provided by Congress to the FDA about misconduct by GSK, and when you look at the numerous independent studies saying that the drug is harming patients, what evidence does the FDA want to have to make a decision that a drug needs to be yanked? What evidence do you need?” Thacker left Grassley’s staff this month for a position with the Project on Government Oversight.

FDA Commissioner Hamburg and Dr. Eichler of the European Medicines Agency each downplayed their split, saying the two agencies agreed on Avandia’s risks but chose different strategies to manage it. “We discussed the decisions with each other. These decisions were not made in isolation,” Hamburg said.

A slight note of discord came from Dr. Janet Woodcock, who heads the FDA division that evaluates medicines, who said “There is still considerable uncertainty of the magnitude and existence of this cardiovascular risk.” In a memo, Woodcock said that patients might still benefit from Avandia if they did not respond to other medications.

Medical groups warned that patients should not stop taking Avandia without first talking to their doctors. A joint statement from the Diabetes Society, the American Association of Clinical Endocrinologists and the Endocrine Society said stopping medication “can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of long term diabetes-related complications.”

In a statement, GSK said it still has faith in its product. Wrote Chief Medical Officer Dr. Ellen Strahlman, “The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions.

Type 2 diabetes is a condition that affects the way the human body metabolizes sugar. Symptoms include weight loss, fatigue, blurred vision, frequent urination, and increased hunger and thirst. There is no cure, but patients can manage their conditions with proper diet and exercise; medications or insulin therapy may also be needed, says the Mayo Clinic.

About 8 percent of the U.S. population - or nearly 24 million people - is living with diabetes, and 90 percent of those cases are type 2, according to the National Diabetes Information Clearinghouse.

Here are alternatives for people with diabetes if you are concerned about Avandia.


soundoff (127 Responses)
  1. 4sanity

    Dave Eaker's post on Green Lip Mussel Extract should be taken with big dose of S.S.E (Scientific Skepticism Extract).

    It's proposed usefulness as a "natural" and safe nutritional supplement to alleviate joint pain/inflammation etc. is highly questionable for the following reasoning:

    1) There is no standardization for the potency of the extract i.e. every batch you buy over the counter will have potentially unknown variable effectiveness.
    2) The quantities you consume are in the homeopathic NOT pharmaceutical range i.e. grey zone where scientific mass action of drug-receptor interactions gives way to magical wishful thinking (placebo) properties.
    3) No large scale clinical studies have been conducted as to its effectiveness for any condition NOR safety NOR drug interactions. The only clinical trials had very small sample groups; follow up double-blind trials failed to find any evidence of anything compared to placebo.
    4) The extract is an unrefined mixture of multiple components not a single defined pharmaceutical. Good luck with defining all its potential side effects.
    5) There are only 21 reference to GLME in PubMed compared to 2143 for rosiglitazone and TZDs. The molecular mechanism for rosiglitazone is quite well understood (PPARg agonist) whereas no mechanistic understanding for GLME exists. Because of this extensive investigation, we know what the potential side effects of rosiglitazone are. Ignorance is not the same lack of deleterious effects nor the basis for claims for safety.
    6) Taking "homeopathic" nutriceuticals is generally a bad idea especially if you are on specific medications. These extracts, if they do contain unique bioactive components, often induce potent xenobiotic metabolism responses in your liver that can seriously perturb endogenous steroid hormone and drug metabolism. Often this renders your "prescription" medication useless e.g. St. John's Wort (hyperforin) causes increased metabolism of birth control hormones –> unwanted pregnancy. Always tell your doctor if you plan to take any of these products –> otherwise you run the risk of severe side effects.
    7) At best, some of these products may have minor benefits. Mostly they do nothing. Occasionally they are outright dangerous.
    8) Unfortunately, the nutritional supplement market has a loop hole to escape proper FDA review as long as they do not claim specific health benefits. That doesn't prevent these modern day vitamin/organic/natural product/snake oil salesmen from relieving you of your money.

    September 23, 2010 at 14:03 | Report abuse | Reply
    • DingDongsKill

      FDA was suppose to fix this food/dietary supplement "loophole" by 2003 but due to lack of funding and manpower the supplement B.S is on hold until 2014.Why doesn't CNN cover the debunked/falsified Ginkgo Bilobo and Chrondrotin studies? You gave those supplement companies your hard earned money...IDIOTS ...I heard green algae is good too...What is the dietary recommended daily dose of Green Algae you ask...0.0mg but it could CURE EVERYTHING from arthritis to schizophrenia.hahahahahaha

      September 23, 2010 at 14:47 | Report abuse |
    • GinkgoMadeMeRICH$$$$$$

      How dare you criticize the lucrative food supplement industry!!! Ginkgo made me RICH!!!

      Signed

      KEVIN TRUDEAU ......google me too!!!! like my suit? hahahahahahaha! THANKS for the YACHT!...I am just as qualified as Elizabeth Cohen....at least listen to Dr.Sanjay Gupta....

      September 23, 2010 at 14:54 | Report abuse |
    • Dave Eaker

      @ 4sanity....

      I do not agree with you.... Why not you call Moxxor Service Care 1-888-366-9967 for information ? You do not know about Green Lipped mussels...... Many people are very positive with Moxxor. I had bad arthritis on my right hip over 20 years. I had taken strong medicine and Alvee all time I took Moxxor The pain was gone in 5 days. Also I no loner taking blood pressure medicine. There has many wonderful Moxxor stories. Green lip mussels are NOT fish oil ! That is HUGE different !
      * 158 times more effective than fish oil
      * 247 times more effective than salmon oil
      * 316 times more effective than Evening Primrose Oil
      * 3950 times more effective than Flax Seed Oil

      MOXXOR is the most powerful, all-natural Omega-3 anti-inflammatory and anti-oxidant on the planet, and it can assist with a lot of health situations, such as:
      Joint Problems, Skin Disorders, Aches and Pains, Breathing Difficulties caused by inflammation, Heart Disease, Cirrhosis of the Liver,Anxiety, Asthma, Rheumatoid Arthritis, Osteoarthritis, Depression, Dry-eye, Psoriasis, Crohn's Disease, Ulcerative Colitis, Lupus, Migraine,Diabetes,Alzheimer's disease, High Cholesterol,Triglycerides,High Blood Pressures, Arthritis and Allergies.
      90 days 100% money back guarantee, no questions asked. It's no risk. If no results, or dislike, just return the bottles and get the 100% money back. It's a risk-free get well program at no charge.

      September 23, 2010 at 17:04 | Report abuse |
  2. PostForElizabethCohen

    "Subscriptions" are for newspapers and magazine.Prescriptions are for medications.Also Avandia was never considered a "wonder drug" In fact it is probably the 3rd or 4th class of prescriptions for type 2 diabetes behind METFORMIN then GLYBURIDE. The only wondering people are doing is how you keep your job title? One of the posters is correct the FDA is screwed both ways they are pressured to "fast track" medications and then are pressured to pull them off regardless of WHO voted for their approval before.FDA is only as good as the data they have and the studies should be submitted by unbiased Universities not the pharmaceutical companies regardless if they are double-blind...
    Diabetics there is no "wonder" drug or supplement.Know your NUMBERS and what you did exercise/nutrition-wise a year ago is ancient history.Insulin(your own or synthetic) resistance is now becoming a problem.The best thing to do is become a "health freak" and get together with a Endocrinologist YOU TRUST and a Registered Dietitian. Follow their advice ,ASK questions and you can live a healthy good life.Food is just fuel and eating is overrated...

    September 23, 2010 at 14:04 | Report abuse | Reply
    • PostForElizabethCohen

      Let me clarify because people twist words on a web board. an endocrinologist who is a M.D. or a D.O. as in a Medical Doctor OR a Doctor Of Osteopathic Medicine that is licensed in the United States...maybe Canada....When I type "get together" I mean a face to face appointment with the appropriate tests and keep your health care records because even though they are ancient history they are important in YOUR therapy.It would be extremely advisable to get a glucose meter that you can put in your flash drive on your computer.Take care and play nice!

      September 23, 2010 at 14:20 | Report abuse |
  3. CubanMom

    This drug KILLS. Can't believe its only being "restricted"! I am no longer plagued with diabetes 2 now that I lost 60 pounds, but I was on this drug for a couple of years. And what happened? TAKING THE DRUG I GAINED MORE WEIGHT! Most diabetes drugs make the patient gain weight...... which is the opposite of what they need! I got off this horrible drug, lost weight and I have been FREE of diabetes 2 for 10 years! People, YOU need to be informed. Beware of drugs! Big Phrama is all about making $$$!

    September 23, 2010 at 14:10 | Report abuse | Reply
  4. Eric in St. Louis

    As a user of Avandamet, I'd like to say I'm disappointed by this development.
    ALL drugs have negative side effects. Even aspirin can kill you (Google: negative side effects of aspirin)!!
    Avandamet helps me control my blood sugar. As has been previously stated, my cells do not respond properly to insulin. So, without Avandamet, I'd be in deep water (for the record, I've tried some of it's competitors with near-crippling side effects).
    I've suffered NO adverse reactions from Avandamet in the YEARS I've been on it. My heart has the qualities of a healthy ATHELETE'S heart!
    I am not some anonymous statistic in a Dr's report. I'm a human being. Just because it harms SOME does not mean it should be demonized.
    Thank you.

    September 23, 2010 at 14:25 | Report abuse | Reply
    • DingDongsKill

      You tell them Eric....I am a human being too........Not diabetic though...happy and healthy .....Race For a CURE Marathon!!!.....Beta Cell Transplant and Stem Cell Therapy LOOKS promising.............Say No to Twinkies.........

      September 23, 2010 at 14:31 | Report abuse |
    • Doug

      Eric, what is an acceptable death rate to you? This drug may work for you, but it killed others. What MD would prescribe a drug with a severe side effect like Heart Attack, or Stroke? You also may be lucky right now, what about threemonths from now? It is clear that the maker of this medication kept the truth hidden, if the FDA did its job it would NEVER have been introduced to the marketplace. If I were you I would find a really good Heart Specialist and a Lawyer, the first to see if you have damage done yet, the second in case you do. I wish you nothing but good health your whole life, I lost my Wife of 23 years do to FDA, and MD mistakes. Eric PLEASE be careful

      September 24, 2010 at 03:39 | Report abuse |
  5. bezerkur

    its called over-population. what other large mammal can boast being at 7 billion and counting. oceans are becomming dead zones by over fishing. you want to see something disturbing go to a factory farm and look at the animals we are eating. see how we pump them full of drugs during and right before slaughter to plump them up. thats only the beginning of the food problems that are contributing to the health problems. another factor to consider is stress. face it these are stressful times. mix that with poor food and its no wonder there is a outbreak in medical issues, especially diabeties. i am fortunate i dont have diabeties. but for how long and for millions of others. food practices must be changed. there is no quick fix like a pill or a shortcut like fillers to eliminate our poisoning food problems. our fate will be decided on education. i suggest the world get educated quickly.

    September 23, 2010 at 14:32 | Report abuse | Reply
  6. content_pessimist

    Have you heard of the new drug that is coming out that will replace Viagra?
    Its called macocksafalin (My-C0cks-a-Faillin).

    September 23, 2010 at 14:43 | Report abuse | Reply
  7. Edwin

    This seems like a reasonable compromise - if you take it because nothing else works, you should still be able to take it.

    September 23, 2010 at 14:48 | Report abuse | Reply
  8. phuong

    It may not be anything new. But im really surprise at peoples ignorance and intolerance

    September 23, 2010 at 14:51 | Report abuse | Reply
  9. Dale

    Nearly 24 million Americans, or about 8 percent of the U.S population, live with diabetes.

    Did you see that Avandia exceeded 3 billion dollars maybe this is a smear campaign, the other drug companies are being hurt by Avandia , money is being emphasized too much in this article.

    Nearly 24 million Americans have diabetes I wonder how many people in the world have diabetes and can afford treatment.

    The market for diabetes treatment is not just in United States there’s more than $3 billion at stake here, “”this whole thing is about money””.

    These big diabetics pharmaceuticals CEOs and shareholders do not care about people’s miseries and sickness caused by diabetes, they only care about how much money they can make off of sick people.

    There will never be a cure for diabetes too much money in it. $$$

    Just like cancer and other diseases, too much money to be made off of diseases. $$$

    September 23, 2010 at 14:52 | Report abuse | Reply
  10. dom625

    Everything that you put into your body can have negative consequences. The question that you have to ask yourself is whether the *possible* side effects are worth the cost of living with a disease and knowing what it will *definitely* do to you. If the risks of heart disease are minimal enough and nothing else treats your diabetes, then you should have access to this medication (if it works for you). The FDA should not ban medications based on a small number of people who have adverse effects if a large number of people are able to be helped.

    September 23, 2010 at 15:07 | Report abuse | Reply
  11. CatfishMammy

    They need be watch they sugar!

    September 23, 2010 at 15:12 | Report abuse | Reply
  12. MarciaMarcia

    I wonder, out of all of the people with Type 2 Diabetes, how many could control it with diet alone? And I'm not talking about a diet that most people THINK is healthy but is still loaded with sugar and carbohydrates- I know people at work that will say they are eating healthy but their diet consists of salad loaded with sugar-laden salad dressing and "healthy choice" meals that are saturated in sugar and msg. But what if acute attention was paid to diet and the amount of sugar/carb intake w/ each meal? There's a documentary that followed people with type 1 and type 2 who went on a strict raw diet and the people who maintained the diet and had type 2 were able to get off their meds. It was only a small sample so you can't say that it will have the same effect for everyone, but it makes you think, doesn't it?

    September 23, 2010 at 15:24 | Report abuse | Reply
    • IndependantVoter

      I agree that sometimes people think they are eating healthy but if a registered dietitian looked at their food consumption the end result may be different.Consumers are getting deceived by certain companies that use buzz words like "healthy" "natural" and "organic"Also serving size is something unheard of and going to bed hungry is a thing of the past with most americans.Exercise is their video games like Wii.

      September 24, 2010 at 04:29 | Report abuse |
  13. TalktoyourDOCTOR

    after reading some of the posts the best advice is talk to your doctor....and ask "does the benefit outweigh the risk?"
    Every case is unique.You as a patient/person are unique. I realize that for some patients Avandia or Actos may be the last choice before insulin therapy but listening to a person on television or a person posting on a web page is not the best advice.Bad information can be worse than no information... CALL your DOCTOR'S office.....

    September 23, 2010 at 16:13 | Report abuse | Reply
  14. Evil

    Funny how the FDA allows people to ingest pills with a side effect list that reads more like a symptoms list yet Marijuana is still illegal...

    September 23, 2010 at 16:19 | Report abuse | Reply
  15. ADiff

    The FDA 'kills' far, far more people by over-regulating than by being too lenient. Lives would be saved by stream-lining the approval process and reducing FDA regulation. Making the process more costly and time consuming or more restrictive will actually end up killing a lot of people. Of course no one will blame the FDA for avoidable deaths from illness and injury that could have been prevented by treatments the FDA effectively denied them....so there's no political 'downside' to just letting them die, and killing still more. Advocates of increased regulation are engaged in an effort to the same ends....they're happy to end up with more deaths, as long as there's no 'smoking gun' to get all hysterical about....but at least for most individual regulatory advocates, unlike the FDA itself and the established large companies they protect from competition, do so simply out of ignorance, rather than malfeasance.

    September 23, 2010 at 16:54 | Report abuse | Reply
  16. Justin

    I can see the lawyers circling avandia's floating carcass. Can you smell the money!!!!!!!!!!!

    September 23, 2010 at 17:33 | Report abuse | Reply
  17. Testament

    Leave it to the Governments (who are controlled by the greedy corperations of the world) To kill off its ppl by telling them something is good when in fact it is not. They allows chemicals pass thru our foods, our water, drinks, air, work environment and so much more. Their mentality? ...Why should we worry bout our slaves? Just support the promotions of s3xx and make some more! >.>

    September 23, 2010 at 18:44 | Report abuse | Reply
  18. anancain

    In america you HAVE A PILL to fix anything... pardon me, I meant to say "cover up, mask" what ails you. Drug companies are for profit and when your doctor pushes pills instead of "pushing you to clean up your unhealthly act", you end up taking one drug to fix the side effects of the first drug. My great grandparents and my grandparents-both sides- lived into their 80's or 90's – without drugs. Now what does that tell you about todays demanding patients....

    September 23, 2010 at 20:09 | Report abuse | Reply
  19. funmilayo kadiri

    americans should reduce their sugar intake n junk food! N i think d FDA should b fast wit der findings wit dis drug so dt it won't take more life!

    September 23, 2010 at 20:29 | Report abuse | Reply
  20. phoenix3

    This drug needs to be taken off the market now. How many people that trusted this drug and GSK have to die or now have life threatening heart disease to deal with in conjunction with their diabetes because of this drug? I was on Avandia for three and a half years and requested to be put on insulin in June of 08 after the issues with Avandia started coming out. In December of 08 I had a heart attack and now almost 2 years and 7 angioplasties later, I'm looking at having to have a CABG when the stents fail again. I'm sure the executives at GSK are to busy counting their bonus dollars and profits from this so called wonder drug to care about the people like me and the families of those that have died after taking this drug.

    September 23, 2010 at 21:18 | Report abuse | Reply
  21. Doug

    Over the past 20 years the FDA has lost sight of why they exist, this drug should NEVER been on the market. It appears the FDA is much more interested in money than protecting the people. If a drugs side effect is death, keep it off the market. Hey, Hey, FDA, how many people did you kill today????????????

    September 24, 2010 at 03:17 | Report abuse | Reply
  22. FuturePost2015

    Januvia and Byetta are not "wonder drugs" for type 2 diabetics also......Adults acting like children...Some adults were given bad genes due to no fault of their own.It is your choice what you do(including today) in regards to exercise and diet.Make the necessary adjustments. it really is a no brainer.Insulin resistance can change and so can your numbers like blood pressure, blood glucose,A1C, HDL.LDL and Triglycerides.Metabolic syndrome will become the next big thing and it can be PREVENTED and DELAYED. Choice and freedom is yours.......Stay Active.... Eat Healthy....Stay Healthy.....NO excuses

    September 24, 2010 at 05:24 | Report abuse | Reply
    • FuturePost2015

      Prevacid,Aciphex,Prilosec ,Prototonix and all proton pump inhibitors from G.I. "issues" are ALSO OVER-PRESCRIBED.......Short-term use maybe but these are not maintenance medications..The drug companies are advertising to patients so you can eat a certain food? are you kidding me? don't eat the food....Sometimes patients are their own worst enemy.......Stay Active Eat Healthy Be Healthy...NO excuses.......there are very few wonder drugs out .......but keep thinking your abusive lifestyle can be fixed down the road by a "wonder" drug. that is what "big pharma" is expecting and it looks like it will happen because you are just a number to them...

      September 24, 2010 at 05:52 | Report abuse |
    • FuturePost2015

      Last one...Prevacid is losing its patent so a generic will coming out soon.Read and learn...The makers of Prevacid have already come out with a Kapidex (brand)which is just another isomer of Prevacid and it will be 160 dollars/month just like Prevacid was......I forgot Nexium also.......$1500.00 to 2 grand a year! ....H-pylori is not as significant as once thought.....I am done......STAY healthy......

      September 24, 2010 at 06:12 | Report abuse |
  23. Denise

    Most of you bloggers are kidding, right? Who was it that said "common sense is not common"? Let's use some common sense here. First of all, there are no "wonder drugs", and there are side effects to ALL DRUGS! Second of all, having Type II diabetes does not mean you're fat and lazy. Eating and exercising properly helps, but not all the time. And last but not least, the big pharmaceutical companies have got to be taken out of the picture. Independent scientific testing has to be done on all drugs before being brought to market, not double blind "pharma" trials. Wake up America! Stop believing everything you read or hear. Do your own research. And unless you've gotten the facts from a trusted source (and I don't mean an internet website) WATCH WHAT YOU SAY! There are actually people out here who believe everything they read or hear! Especially if "THE GOVERNNET" (yea, I said governnet) or the "INTERNET" says its true! And truly, my sympathy goes out to all those who have lost loved ones due to the use of this drug, make God Bless and Keep you and your families!

    September 24, 2010 at 09:23 | Report abuse | Reply
  24. HealthcareWorker

    FDA should have pulled it off the market along with Meridia.In my eyes 1 death is too many.First do no harm.I am just curious.Are there any type 2 diabetics that their doctors prescribed Avandia first? It is NOT a first, second or even third choice of treatment. Do people think it is a wonder drug because of all the television and print advertisements?Who do you think pays for all the advertisements in the long run? Onglyza or Januvia are not wonder drugs for future reference.All drugs and supplements have SIDE EFFECTS including tylenol which can do some liver damage pretty quickly. Stay Healthy

    September 25, 2010 at 06:30 | Report abuse | Reply
  25. HLO

    First, type 2 diabetics are already at increased risk for cardio-related comorbidities, so it was never a surprise to anyone that Rosiglitazone – or any medication for Type 2 – would have safety risks. This is why they are listed on the commercial. That each med works differently on different people is why there are so many drugs for the same purpose. Every doctor considers the risk/benefit of medications prescribed.

    The truly sad thing about Rosiglitazone is that it was found to offer at least some mild improvement in Alzheimer's patients who don't express the ApoE4 allele. However, no further development or tweaking of this medication will ever occur now.

    Only 11 cents of every healthcare dollar is spent on medication. When you consider that it costs HUNDREDS OF MILLIONS of dollars to get just ONE drug to market should make us glad that we ever get any pharmaceuticals at all. I, for one, live better thanks to a particular Cox-2 inhibitor that is dangerous for others, but has worked great for me, for years. If and when the FDA pulls that one off the market, I'll be back at square one, trying to find another pain management remedy. Here's hoping that day never comes.

    September 25, 2010 at 21:37 | Report abuse | Reply
    • FuturePost2015

      Good post Hlo,
      I am in healthcare and working the graveyard shift.I never heard of Avandia for helping with Alzheimers but it is hard to keep up.I have heard of a research project for Alzheimers going on where they are using the statin class.When Avandia and the TZD class first came they did say there was side effect risk of a cardiovascular event but with the Cleveland clinic research it claims that risk is 6 times higher than what was originally thought.He is a well known and respected cardiologist with no association with Glaxo or the FDA.It was never a "wonder drug" because it could never be used alone for type 2 diabetes.I think it should be pulled because the risk outweighs the benefit and Actos which is in the same class should be watched closely.Many people don't realize with each prescription now there is an FDA phone number side effect hotline.Avandia is due for a generic soon and it will interesting to see if a generic company takes the risk and makes it or Glaxo stops production.
      I am wondering what your Cox-2 inhibitor is? Celebrex(which is staying on the market and is in clinical trials to help with colon cancer),Bextra or Vioxx.In my opinion the strength of 50 mg Vioxx was too strong.All cox-2 and NSAIDS for that matter raise the blood pressure as many as 20 points.ER docs mostly prescribed the Vioxx 50mg for short term use.The case that sealed Vioxx's fate was a 50 year old Texan triathlete who was in great shape before he took the medication for an ankle sprain and then had a stoke after taking Vioxx.The family was awarded an obscene amount of money and Merck(Vioxx maker) is appealing the ruling.1 death is too many.Vioxx was due to come off patent also.

      I wish the FDA would end all drug advertisements because the advertising companies make the medication look like a miracle drug side-effect free because that is their job.Drug companies can advertise the disease state talking about the disease itself and what the patients should be looking out for and say at the end the commercial was paid for by the drug.Because once the drug loses patent and goes generic you never see the commercial/print advertisement again.So does that mean the drug comapany no longer cares about the patient?For instance Merck could run a commercial about what a patient should be looking out for in type 2 diabetes and then say paid for by the makers of Januvia.

      The most disturbing trend I see on these boards is that some people think that health care workers are out to knowingly hurt patients.That medical personnel receive kickbacks from big pharma.Some doctors get drug samples from big pharma and dispense them for patients who cannot afford them or their co-pays.I went into medicine to help people not to become a millionaire and hurt people.Medicine is very humbly your day can be going well and then you get a phone call that one of your patients is not doing well or worse.

      September 26, 2010 at 05:33 | Report abuse |
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.