The maker of Accutane, a controversial acne medication, disregarded a company doctor's recommendation that users of the drug be monitored for signs of depression and that a warning to that effect be added to the drug's U.S. label, allegations in a federal court case show.
Six weeks after Amanda Callais, 21, started taking Accutane, she tried to kill herself.
The Florida lawsuit against the drugmaker, Hoffmann-La Roche, charges that the Swiss drug giant omitted the warning after its marketing officials argued that such an alert could cost the firm sales or prompt lawsuits. The doctor's recommendation and the marketing debate sketched in legal filings have not been previously publicized.
There has been no official finding that links Accutane to depression or other psychiatric illnesses. Roche says the drug is effective when used properly. Nonetheless, a senior Roche official, testifying in a pretrial deposition for the Florida case, said the firm's internal analysis showed Accutane "probably caused" depression and other psychiatric illnesses in some patients, according to a summary of the deposition in a court brief.
The internal debate alleged in the case comes to light after a U.S. Food and Drug Administration researcher last month told a Senate panel Accutane was one of five drugs that should be studied for possible withdrawal from the market. The FDA has since moved to tighten safeguards against the major side effect: birth defects in children whose mothers took Accutane while pregnant.
The alleged internal corporate debate over an Accutane warning, which emerged from a USA TODAY review of Accutane lawsuits, also comes as the recent withdrawal of another drug, Merck's pain reliever Vioxx, has intensified scrutiny of both drug companies and the FDA's oversight of the industry.
More... (bit long article): http://www.usatoday.com/money/industries/health/drugs/2004-12-06-accutane-cover_x.htm
Right after one whisteblower exposed about FDA and Vioxx problem surfaced, seem that people finally stand up and speak out. That's good news and that is only the beginning.
Six weeks after Amanda Callais, 21, started taking Accutane, she tried to kill herself.
The Florida lawsuit against the drugmaker, Hoffmann-La Roche, charges that the Swiss drug giant omitted the warning after its marketing officials argued that such an alert could cost the firm sales or prompt lawsuits. The doctor's recommendation and the marketing debate sketched in legal filings have not been previously publicized.
There has been no official finding that links Accutane to depression or other psychiatric illnesses. Roche says the drug is effective when used properly. Nonetheless, a senior Roche official, testifying in a pretrial deposition for the Florida case, said the firm's internal analysis showed Accutane "probably caused" depression and other psychiatric illnesses in some patients, according to a summary of the deposition in a court brief.
The internal debate alleged in the case comes to light after a U.S. Food and Drug Administration researcher last month told a Senate panel Accutane was one of five drugs that should be studied for possible withdrawal from the market. The FDA has since moved to tighten safeguards against the major side effect: birth defects in children whose mothers took Accutane while pregnant.
The alleged internal corporate debate over an Accutane warning, which emerged from a USA TODAY review of Accutane lawsuits, also comes as the recent withdrawal of another drug, Merck's pain reliever Vioxx, has intensified scrutiny of both drug companies and the FDA's oversight of the industry.
More... (bit long article): http://www.usatoday.com/money/industries/health/drugs/2004-12-06-accutane-cover_x.htm
Right after one whisteblower exposed about FDA and Vioxx problem surfaced, seem that people finally stand up and speak out. That's good news and that is only the beginning.