The New York Times
By Gardiner Harris and Natasha Singer
August 13, 2010
At least a dozen major drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening bribery inquiry into whether the companies made illegal payments to doctors and health officials in foreign countries.
In previous investigations, federal officials have charged that some companies made these kinds of payments to encourage doctors abroad to order or prescribe their products. In the United States, companies routinely hire doctors as consultants to market drugs and devices to their colleagues and other health professionals at medical conventions and small gatherings. Such consulting arrangements are legal in the United States as long as the companies do not pay doctors directly to write prescriptions for their products.
But in much of the rest of the world, doctors are government employees. And even consulting arrangements that would be considered routine in the United States might violate the Foreign Corrupt Practices Act, particularly if the payments are outsize or the arrangements are not disclosed to the governments.
Of even greater concern to prosecutors in the United States are unusually large payments made to foreign doctors who oversee the growing number of clinical trials that drug and device makers conduct abroad, according to Kirk Ogrosky, a former top federal prosecutor who now represents drug and device makers at a Washington law firm.
More than 80 percent of the drugs approved for sale in 2008 involved trials in foreign countries, and 78 percent of all people who participated in clinical trials were enrolled at foreign sites, according to a recent investigation by Daniel R. Levinson, the inspector general of the Department of Health and Human Services. Medical ethicists have long worried that many of these trials are conducted in countries that federal auditors rarely visit and where research controls may be scant.
Now, prosecutors are investigating whether the payments made to doctors who conducted these studies abroad were appropriate. If evidence shows that such payments have influenced the results of some clinical trials, prosecutors will be inspecting the trials closely, Mr. Ogrosky said. An article about the inquiry appeared Friday in The Financial Times.
Last month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events. Many of the study’s trial sites were in foreign countries, and the study is a main reason that Avandia remains on the market in the United States. Government officials have not accused GlaxoSmithKline, the trial’s sponsor, of fraud.
“At the Justice Department, investigations that involve allegations of patient harm rise straight to the top and will attract the immediate attention of the F.B.I.,” Mr. Ogrosky said.
Read entire article here: http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=2&hp
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