Should The FDA Tell Abbott To Withdraw Meridia?
6 CommentsBy Ed Silverman // January 22nd, 2010 // 8:50 am
Two regulators, two different approaches to risk. Yesterday, the European Medicines Agency told docs to stop prescribing Abbott’s Meridia diet pill, because the risks outweigh the benefits, and decided Abbott’s license to market the pill should be suspended (look here). At the same time, the FDA added new warnings highlighting increased risks for patients with heart problems but reserves further action until full results arrive in March and a committee meeting is held (see here).
The varying decisions were made after reviewing data from a trial known as SCOUT, which emerged last November and showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, when comparing the drug with a placebo among nearly 10,000 patients. The trial was designed to assess the impact of weight loss on cardiovascular problems in a large group of overweight people taking the pill (see more in The Pink Sheet).
After the results were released, Public Citizen’s Sid Wolfe, who recently petitioned the FDA to yank Meridia (see here), had this to say: “It was the EMEA that ordered the study, has looked at the results and is now banning the drug. The FDA, au contraire, has said they will not get the results of the study from Abbott until March, will then bring the matter to an advisory committee and, for now, just increase the label warnings. Once again, it is clear that under its present leadership, FDA’s CDER is not willing to adequately protect the public health even with clear evidence of risks outweighing benefits for drugs such as Meridia.”
What do you think?
Should The FDA Urge Abbott To Withdraw Meridia Now?
- Yes (71%, 65 Votes)
- No (29%, 27 Votes)
Total Voters: 92
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patrons99
Yes, along with Adderall, and most of the ADHD/ADD meds. They are all “uppers” (stimulants) which put a burden on the heart. The LABAs safety is also very much issue. The FDA’s Black Box warning as to an increased risk of “asthma-related” death on the LABAs seems to ignore the risk of cardiac-related deaths. Cardiac-related SAE’s are probably being dismissed (not captured) as not related to LABA treatment. Yes, most patients on LABAs have asthma and/or COPD (emphysema/chronic bronchitis), but many have concomitant heart and lung disease. All-cause mortality (asthma-related and cardiac) on the LABAs should be analyzed.
pharmavet
I attended the FDA Advisory Committee on Meridia 1in 1996. At the end of the meeting, the Committee vote on three key questions was as follows:
1) Does Meridia meet criteria for effectiveness?: Yes (n=9); No (n=0)
2)Is the pressor effect of Meridia clinically important?: Yes (n=8); Abstaining (n=1)
3) Do the benefits of Meridia outweigh the risks? Yes (n=4); No (n=5)
Eventually the FDA went against the advice of its own Advisory Committee in approving Meridia. Perhaps the reason for their decision was that during this period of time a number of serious AE’S on Redux were pouring into FDA and they were looking for a “safer” alternative. Actually this is a fairly standard way that FDA approaches approvals based on prevailing risk in the marketplace.
I’ve provided the link to the transcript of the Advisory Committee Meeting below.
http://www.fda.gov/OHRMS/DOCKETS/ac/meridia.htm
M Helm, MD
An alternative approach for weight loss is a combination of increased physical activity with a decrease in caloric intake. I believe that to be both safe and effective, though some would probably argue that there are insufficient trial to conclude this.
It may matter what type of calories are ingested. I usually suggest to avoid calories which come prepared in a box or bag. Especially avoid those calories which derive sweetness from high fructose corn syrup instead of sugar, honey or actual fruit, or are deep fried. It also may matter where the calories are consumed. I recommend never to eat with a television, and only at a table from an appropriately sized plate or bowl, never from a bag or a box. Cars are for transportation, not mealtime.
There is much controversy also about what is the “correct” formulation for increased physical activity. There are also important safety concerns. Nevertheless, I believe that the formulation and dose frequency can be safely titrated by most reasonable practitioners on an individualized basis.
Sadly, these alternative treatments lack the advantage of convenience. As my grandparents might have said: “Nothing good is ever easy. Nothing easy is ever good.”
Pharmavet provides yet more example that there is a problem with philosophy and mission at the FDA. With luck the new top levels will help to restore credibility, but there will be political costs.
vince
For quite some time there has been an increasing tension between the safety review arm of the FDA and the drug development arm which simply has more say. Perhaps it should be called the bad drug rehab department.
Former Pharma Marketing Director
I am with Dr. Helm, the first thing we have to do is get back to good dietary basics. Obese patients should be asked to read “Food Politics, How the food industry influences nutrition and health” - Marion Nestle. They may realize that all food on the shelves at the grocer are not safe or healthy and that most additives in foods have not been tested for safety, especially since they are invariably combined with many different foods and chemicals depending on one’s diet.
Marion Nestle has worked at the USDA and the FDA and knows that the FDA and USDA work was completely scrutinized and undermined/influenced just as much as the Pharma industry does the same to the drug side of the FDA.
Food is medicine. We need to start educating the general public at a much earlier age. Many of the chronic diseases of today are a direct result of the poisons and toxins we have dumped into the food chain.
One magic diet pill is not going to fix the problem. How credible is any company who markets a quick fix solution like that? What is the difference between a company who sells these pills and the company who sells special “herbs”.
The last thing an obese person needs to do is add one more chemical to the toxic lab or I should say flab, growing in their body.
Eat less and make healthier choices, whole and no processed foods. Move more..
The EMA are doing their job in protecting the health of their citizens and working to ensure that their health care dollars get spent wisely. We continue to miss this opportunity here…frustrating…
patrons99
We need far fewer “magic pills” in the marketplace. We need healthier lifestyles. We need a healthcare system that encourages and rewards healthy lifestyles. “Magical” is the perfect adjective for many of the marketed drugs today because the data supporting their safety and efficacy are often tenuous at best. Meridia is certainly NOT the only dangerous drug in the marketplace. I hate to be repetitious, but there IS a drug safety crisis in this country. Pharmavet’s post (above) in this thread provides a perfect example of how broken the system really is. So-called FDA Advisory meetings are a joke, a sham, kangaroo courts, strictly for PR purposes. FDA management is unlikely to ever in any substantive way, injure the franchise (pharma).