Two days after launching an investigation into four deaths linked to the Diane-35 acne medicine sold by Bayer, which is also prescribed as a contraceptive, French authorities have halted the sale of the drug. More than 300,000 women are using the drug for contraception, according to the National Agency for the Safety of Drugs and Health Products.
The deaths were attributed to venous thrombosis, a risk that has been noted with the drug and an issue that prompted French authorities to ask the European Medicines Agency to change prescribing guidelines for third- and fourth-generation oral contraceptives after the drugs were found to carry a higher risk of blood clots compared with earlier versions of the medicines (see this and this).
Since 2011, French authorities have been reviewing the risks and benefits of medicines that were approved for use prior to 2005. And they note that, since 1987, 113 other non-fatal cases of venous thrombosis have been reported (see a question-and-answer summary here). The suspension also covers generic versions.
"This drug is not licensed for use as a contraceptive," ANSM director Dominique Maraninchi told a press conference, according to France24. "...But it is being used as such, in this secondary role... yet there are plenty of other alternative contraceptives that can be used in this country."
The move to suspend sales is significant because this signals a tougher stance by authorities in a major Western market toward safety, an issue that in recent years has plagued other regulators - notably the FDA in the US - years after several controversies. French authorities have been haunted by one scandal, in particular, that appears to be shaping regulatory thinking.
This involved the Mediator pill that was sold by Servier as an appetite suppressant for overweight diabetics and linked to heart-valve damage. Government investigators contended the risks were deliberately concealed. As many as 5 million people took the pill between 1976 and November 2009, when it was withdrawn - several years after it was yanked in Spain and Italy.
French health inspectors say Mediator should have been withdrawn a decade earlier. The government was lambasted after a former health minister was linked to the controversy following reports that two of his former advisers – a doctor and a public health expert who was in charge of research at the ministry – had once worked for Servier.
Last month, 9o-year-old Jacques Servier, who founded Servier Laboratories, was formally placed under investigation on suspicion of manslaughter in connection with his role in the scandal over the Mediator diabetes drug, which has since been blamed for at least 500 deaths in France (back story).
7 Comments
It's estimated that 100,000 people a year die in the U.S. of lethal side effects of prescription drugs. If these were car accidents, you can bet your bippy there would be Congressional outrage, hearings, and all the rest.
About 500 people in the US die from seat belt and airbag related injuries too. Looking at only the negative side of the equation, these items should be removed from motor vehicles. The problem is that this reasoning ignores the fact that overall deaths from vehicular accidents have fallen by nearly half since these devices became required equipment.
About 30,000 Americans die during or even in the aftermath of surgery. Perhaps we should ban that as well.
Drugs are not approved based on their safety, but based on their risk/benefit ratio. Warfarin, insulin, cancer drugs, and even penicillin kill people every year. But the reason they are on the market is because they are far more likely to extend life than to shorten it.
Odds are you're alive today because of one or more of the pharmaceutical industry's products.
You're welcome.
What has YOUR time with the relay stick produced?
In the case of antibiotic research, THAT was done as a WWII war time effort because of the disease that ALWAYS follows the leveling to the ground of city infrastructures - the whole "bombs away" thingy that adds lots of nasty to waste not being processed.
Whart did billions of taxpayer dollars buy this last go round? Docs who figured out where to attach the artificial limb because they used live, and unwilling, subjects to figure out nerve ending's pain threshold?
I leave it up to you to find the origins of the other drugs that you listed.
If people want to limit their criticisms of the industry to deaths caused by drugs that were approved within the last 10 years, I'll be happy to limit my responses to the discussion of the benefits of drugs approved in the same timeframe. But the fact is, the vast majority of the 100K deaths that pharma critics like to bring up at every opportunity are due to drugs that 1) are 40 years old or more, and 2) still have a favorable risk/benefit ratio in spite of their non-ideal safety profile.
As I've followed the industry, not been in it, I haven't been in any sort of catbird seat, but it seems to me some of the best and brightest have been laid off - replaced by slick marketing guys. What I once supposed was a pretty noble industry, full of people who cared - seems now to be driven solely by a bottom line mentality.
What would it take to change this?
My point is that like most controversial subjects, partisans tend to pick the most extreme estimates and interpretation of the data. 100,000 deaths a year is a reasonable estimate for the number of deaths caused by prescription drug AEs each year. But it needs to be said that most of these deaths were caused by drug approved 40 years or more ago. And the reason these drugs are still on the market is because we are better off with them than without.
Vioxx did cause a lot of deaths (though 50,000 is on the high side of reputable estimates). But without trivializing this number or the the associated cover-up, this episode does not begin to obviate the favorable impact on society of other drugs developed in the same period.
These include
1) the risk of death in epileptics is inversely proportional to their adherence to drug therapy.
2) Contrary to the common wisdom of the internet (fed by populist but not academically highly regarded authors such as David Healy), the overwhelming majority of studies show that antipsychotic therapy is associated not only with reduced risk of hospitalization, but also with reduced mortality.
3)There is overwhelming data that the use of statins in secondary prevention has played a important role in the halving of the death rate from CV disease since the 1970's (from roughly 1.2 million per year to around 600K. This reduction in death rate appears to be mainly an effect of better treatment, as cardiovascular disease prevalence has remained approximately constant.
4) Treatments for MS and RA have been demonstrated not only to provide symptomatic relief, but to slow the progression of disability.
5) Antidepressants are certainly not wonder drugs, but they clearly work in those most in need of them. Whatever you may read on the internet you'll be hard pressed to find a psychiatrist on the staff of any major medical school who will dispute this.
6) Recent advances in the treatment of hepatitis C are expected to prevent 150,000 cases of liver cancer and half a million cases of cirhosis over the next 20 years.
7) Know anyone with HIV? In 1990, the 500 student college where I completed my BA started running an obituary column. It doesn't show up in most issues anymore.
I wouldn't call the industry noble, but to suggest it has done more harm than good is discredited by even a casual investigation into the facts.
Actually, John, once you KNOW what an "antibiotic" is, finding new and better molecules is what the medical research relay race is all about. So your argument that continuing to find new antibiotics is "a giant-er leap for mankind" than the original discovery was, is typical of your thought process, not knowing where the horse gets hitched on the "science" bandwagon - behind or in front of the cart...?
As for managing genetic diseases, people have traditionally done it everytime they unzip their pants. There's a real risk in expecting that being rich enough to breed haphazardly can continue to be done on the backs of the healthy *slave labor* class in USA.