Roche Says Accutane Withdrawal Has Nothing To Do With Suicides
Pharmaceutical giants, Roche, have pulled their anti-acne medication, Accutane, from the US market just over a week ago, but it continues to say this had nothing to do with the huge amount of court cases that are pending globally, regarding psychiatric side-effects which may have led to hundreds of suicides and some murders too. It will continue to distribute the medication under the Roaccutane name outside the US and even though the history of this drug is unforgivable, the FDA have never took it off the market, and it now bows out, according to Roche, due to having such a small slice of the US market. For purely economic reasons! Who would have thought that?
July.08.2009 - Robert Knight, Blatant News Correspondent
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THE BIRTH OF ACCUTANE
Accutane was first introduced by Roche to the market in 1982, after they themselves developed the drug. It's real medical name is 'Isotretinoin', but Accutane is the brand name which Roche decided upon for use in the US market. It markets it as Roaccutane outside the US, and many other drug companies market Isotretinoin under many other brand names too. It is derived from Vitamin A, and small doses of it are found in our bodies naturally. It's main usage is for people who suffer from extreme cases of acne and is often described as the last point of call for people who's skin is being scarred by their acne problem, but in recent years it has been gaining a bad reputation for it's side-effects, most notably psychotic and depressive episodes, but also for some medical problems too. It is generally only given with proper supervision by a dermatologist, and a course of it can last from 2-5 months typically. It has been shown to get rid of some of the worst cases of acne, but it has also been proven to be a highly dangerous drug too.
THE CHARGES AGAINST
If you start googling the drug name, you will begin to see the sheer amounts of users who have been affected by this drug. There are tons of support groups, and campaigns, trying to get it taken off the market. It's danger is only half of the story though, as Roche is also criticised for not providing ample warnings on their packaging for the drug, and only adds warnings if a particular country forces it to do so. This has led to very different warnings on the packaging for the drug in different countries. Even though they have the same information available to them, from the same clinical studies. This is a usual ploy of drug companies when bad side effects are noticed in their drugs. They do whatever they can to hide them in each country, one by one, until they run out of markets that don't trust them anymore.
HOW THE SIDE EFFECTS WERE FIRST NOTICED
It was only in 1996 that the psychiatric side effects of the drug came to light, when a US Food & Drug Administration (FDA) physician noted two cases of suicide in a routine listing of recent adverse events associated with Accutane. By 1997 the French had added 'suicide' as a side effect to their labels. Ever since then there have been many suicides blamed on Accutane, and more recently there have been a handful of US murder cases blamed on the drug. At the moment there are thousands of personal injury claims against Roche just about to hit courts all over the globe, and Roche admits to up to 5,000 in the US alone and it blames the cost of these, coupled with just a 5% stake in the market in the US, as being the reasons for it's departure from the American market.
WHY IT FAILED
There are many reasons why Roche needs to take this drug out of play in the US, the main one possibly being the economic one if cites. But this low market share for Accutane came about due to the FDA putting tighter and tighter restrictions on its prescription, and because people became aware of some of the terrible side effects associated with the drug, and the high percentages of users that suffer from them. Last month it had to pay out US$2.5m to one former user, and US$12.9 collectively to another three. The shit is about to hit the fan & Roche are getting out now. But to do so globally would be a form of economic suicide, as it would look like they are guilty, so they will continue to put the lives of non-US acne sufferers at risk to save their own skin. It's all about the dollars, and they are doing what they need to, to dampen the flow of money out of the company.
THEY KNEW ALL OF THIS!
It is believed that Accutane doubles the risk of depression, and the vast amounts of suicides linked to the drug are solid evidence of this. As far back as 2002 the UK Medical Control Agency was aware that there were 15 cases of suicide, 10 cases of suicide attempt and 13 cases of suicide ideation totalling 38 UK cases at that time. This was from just 50,000 patients prescribed in the country between 1983 and 2002, and it only included those that had come forward. The real total is thought to be about 10 times this amount. At that time the US FDA had forced Roche to include a 12 page booklet - who would read anything that long? - about the possible reactions to the drug and what to look out for, but the warnings only ran to 1 page in the UK packaging. It seems that all countries' government drug regulation agencies would have known about this situation for a long time, but they have all gone along with the drug giant. It has been suggested that Roche have friends in high places, and with this kind of evidence, that much is clear. How the various drug agency's around the world still allow this drug to be legal is anybody's guess?
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