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The FDA and the drug industry it is supposed to regulate have been the target of harsh criticism in recent years. The last couple of months have brought even more attention to the issue of public safety. The debate is intensifying, involving the FDA, drug companies, consumer groups, internal scientists and doctors. In the meantime, the public doesn''t know which side to believe and what drugs are really safe to take.
AstraZeneca makes Crestor cholesterol drug and insists the drug is safe. According to the Public Citizen consumer group, the same reports AstraZeneca says shows Crestor to be comparable to other cholesterol drugs show the drug has a higher than average rate of problems. In November, an FDA scientist and whistleblower, David Graham, told Congress that Crestor is linked to kidney failure and a rare muscle disorder called rhabdomyolysis.
Shortly after Graham''s statement, the FDA issued a statement saying the drug agency was not in agreement with Graham, but then in December the FDA cited AstraZeneca for making false or misleading claims about Crestor risks in newspaper print ads. Still, Crestor''s multi-million dollar advertising campaign has continued to appear on television, in newspaper and in magazines. AstraZeneca spent $122 million on television and print advertising for Crestor from January through September this year alone.
Crestor is just one example of the growing concern over drug safety that has continued to gain momentum in recent years. Just three years ago Baycol, another cholesterol drug, was pulled from the market after being linked to at least 31 deaths from rhabdomyolysis. It can take years after a drug receives FDA approval for side effects to emerge. Sidney Wolfe, the director of Public Citizen''s Health Research Group, urges the public to avoid new drugs for the first seven years on the market unless a major breakthrough has been made and there is an absence of other options.
There appears to be a misconception among the public that drugs heavily marketed are safe, and the increasing budget drug companies have put towards direct-to-consumer advertisements worries many critics. The British medical journal, The Lancet , slammed AstraZeneca just months after Crestor was approved in an editorial claiming the company “pushed its marketing machine too hard and too fast” with Crestor, and that doctors must communicate to their patients Crestor “has an inferior evidence base supporting its safe use.” In its first week on the market, more than 18,000 prescriptions for Crestor were written.
Pubic Citizen petitioned the FDA to remove Crestor from the market in March, and AstraZeneca continues to say it is confident in the safety and efficacy of the drug. For consumers, the mixed messages have hurt public confidence and have left many patients with more questions than answers.
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