WASHINGTON (Reuters) - Quicker drug approvals and sophisticated marketing campaigns may be putting more patients at risk of dangerous side-effects but the same techniques might be put to use to protect them, a researcher argued on Tuesday.
New U.S. Food and Drug Administration procedures have clearly sped up some drug approvals, said Dr. David Kao of the University of Colorado Health Sciences Center.
For example, Merck & Co Inc’s anti-inflammatory drug Vioxx, or rofecoxib, had been tried by 20 million patients before it was withdrawn in 2004 because of its heart dangers.
Writing in the British Medical Journal, Kao said the 1992 Prescription Drug User Fee Act, or PDUFA, which authorizes fees from companies to beef up the FDA and speed drug approvals, cut the time needed to review a new drug from 33.6 months during 1979-86 to 16 months by the 1997-2002 period.
The revenue from the fees accounts for 43 percent of the FDA budget for drug oversight. Similar fees make up 75 percent of the funding for the European Agency for the Evaluation of Medicinal Products and all of Britain’s Medicines and Healthcare Products Regulatory Agency funding.
“It’s probably not helping drug safety,” Kao said in a telephone interview.
The closer to deadline that a new drug is approved, the more likely it is to later need strong safety warnings or to be withdrawn, he noted.
But drug companies may have the answer.
“I think the pharma companies are using ingenious methods of marketing,” Kao said. “And I think that the infrastructure is already there and we can capitalize on it to improve drug safety.”
New drugs are usually tested on a few thousand people at most, with rarer side-effects becoming evident only when they are used in the wider population. Watching for these effects is called post-approval surveillance.
“We just have very poor post-approval surveillance now,” Kao said. “People are going to want new drugs and it is going to be impossible to guarantee their safety before a lot of people get them.”
Companies could use multimedia techniques now used to sell their drugs to help patients watch for dangers, Kao said.
He cited the example of Merck’s Januvia, or sitagliptin, a diabetes drug.
“The FDA approved sitagliptin 3.8 years after the drug’s discovery; this compares with five years for rofecoxib and an industry average of 14.2 years between 1990 and 1999,” Kao wrote.
“Once the drug was approved, Merck began a multifaceted marketing campaign that capitalized on sitagliptin being a new class of drug,” he added.
“The product Web site was functional within 90 minutes of approval, and within eight days, Merck had reached 70 percent of target doctors and made first deliveries of sitagliptin to pharmacies. Within 14 days, discussions were completed with managed care organizations covering around 188 million patients or 73 percent of the insured U.S. population.”
Kao said he was not implying that Januvia will endanger any patients.
“It is an example of great marketing,” he said. “Those techniques could be used for post-marketing surveillance too.”
Editing by John O’Callaghan
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