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"Diabetes Drug Still Has Heart Risks, Doctors Warn"New York TimesJune 6, 2007" ...A supervisor in the drug safety office at the agency said in an interview yesterday that she was rebuked last year after calling for a stronger warning label on Avandia and a competing drug, Actos.The supervisor, Dr. Rosemary Johann-Liang, said that in March 2006 she approved a recommendation from a safety reviewer at the agency that the drugs be required to carry the strongest warning, a so-called black box warning, because they posed a risk of unusual swelling that could lead to heart failure.But after officials at the agency who dealt more closely with Glaxo complained, Dr. Johann-Liang said she was ordered to retract her approval of the warning, lost her power to approve such assessments and no longer supervised reviews of the safety of Avandia and Actos.“This was a very careful review that came to an inescapable conclusion,” Dr. Johann-Liang said in the interview. “They decided to act like the review never happened and punish me for approving it.”Senator Charles E. Grassley, Republican of Iowa, has investigated Dr. Johann-Liang’s accusations. Mr. Grassley sent a letter on Monday to the Food and Drug Commissioner Andrew C. von Eschenbach demanding that he investigate the case. ..."-
Yes, Avandia like any drug has potential side effects, including heart failure, which can be caused by fluid retention However, according to facts that we have so far, the benefits still outweigh the risks for the vast majority of diabetics snd this drug is still a highly effective treatment. Now, this report you quote is based on meta-analysis, if you look carefully a that study (Google it) the data is less than clear and conflicting. The research is shaky at best. This drug has a similar cardiovascular risk profile to other diabetic medicines .Again, a problem with one drug or data does not equate to conventional medicine/big pharma FAIL. How about going for the needle, rather than the entire haystack ??What about all the other drugs that have actually saved lives? It's fallacious to suggest everything big pharma do is bad based on possible problems with certain drugs. The FDA/NICE requires drugs to have demonstrated evidence of efficacy and safety. The drug obviously still meets the criteria.============================================@Frecotose: In a previous answer and told us that Crestor had been withdrawn in the UK, which is incorrect and now you are making assumptions about my views on Crestor being given to otherwise healthy people. I have written many times before about Crestor.Now, giving Crestor to otherwise healthy people with no specific risk factors for HD is not something we do here in the UK. Much of the suggestion about giving Crestor to otherwise healthy people was based on these reports:- suggests people with elevated C-reactive protein levels would benefit from this drug. However, even if Crestor is safe and effective for primary prevention of heart disease in people with normal lipid levels, in my opinion it does not mean we should give it to everybody, for the following reasons:-First, we still don’t know the exact role of CRP in cholesterol. And it's a bit too soon to go out waving flags until a proper link can be established. We don’t know whether the benefits from this drug are related to the lower lipid levels or indeed if lower cholesterol is a maker for other factors which may be the actual benefit.Second problem is this, the study only involved people with elevated CRP levels. It does not mention those with normal CRP levels and this study was short term, the long term effects of Crestor in this situation/criteria haven't been established, in particular with young people.Next problem, LDL cholesterol levels dropped quite low with this drug and we do not know the long term risks in otherwise healthy people, in particular with young peopleAny plan to a drug given for prevention needs to assess all risk factors and in my opinion, this study is not enough to justify statin treatment in otherwise healthy people. On a plus side, many of these studys do re-inforce the fact that the vast majority of people who take statins, do so safely and effectively.In relation to this question, I don't know on what exact basis the FDA have approved Crestor in otherwise healthy people. I'd need to have a look at the report. However, the FDA/NICE aren't not perfect, but again, the point I was making is that this does not mean everything they do is bad, and it's fallacious to suggest otherwise.
Sigh, utter failure, time and again.This is a bit like saying "I ate an egg salad once and got ill, from now on I'm eating only cardboard".Just because something might make you ill, is not a reason to give up on food completely and eat something with no nutritional value.You'd have to be insane to not try a life saving drug, when the alternative is a deluded individual with a magic wand pulling bunnies out of a hat.
Governmental regulation of drugs is not perfect, but if the alternative is a return to the days of the traveling salesman pushing his heroin/cocaine miracle cure on unsuspecting parents to use on their children, I'll opt to keep this system. How about we work on improving it rather than trying to get rid of it?And if you want an idea of what the lack of government protection does, simply visit the quack (I mean alternative) cancer clinics in Mexico.
No"The FDA...requires drugs to have demonstrated evidence of efficacy and safety"..Lieas an example, given before, Crestor has been approved for use in healthy people. Where is the evidence of efficacy and safety? just one of numerous examples ignored by those of the pseudo ilk. FAIL with your dogmaEDIT: fallacious argument R### FAIL
problems with one drug doesn't mean this is common? no, it doesn't, but it's so obvious that they are common that to infer otherwise is simply dishonest. reports like this are in the news all the time.