Hawaii's attorney general is suing the makers of a widely prescribed blood thinner that he says a significant portion of the state's population has difficulty metabolizing.
Attorney General David Louie filed a lawsuit Wednesday against the manufacturers and distributors of Plavix, marketed to work similarly to aspirin to prevent a stroke or heart attack.
Louie alleges the manufacturers failed to disclose that Plavix has "diminished or no effect" on people of East Asian or Pacific Islander descent because they metabolize it poorly. He said the drug puts them at risk for gastrointestinal bleeding and other complications. He wasn't aware of any deaths as a result.
The suit names Bristol-Myers Squibb and Sanofi-Aventis as defendants. In a joint statement, the companies said they won't comment on pending litigation.
"Plavix is one of the most studied medicines with over a decade of real-world experience in patients with acute coronary syndrome, recent stroke, recent heart attack and peripheral arterial disease (PAD)," the statement said. "Plavix has been prescribed to more than 115 million patients worldwide, including more than 50 million in the United States."
But Louie said the drug is ineffective for a significant portion of Hawaii's population.
He said more than 1 million Plavix prescriptions have been issued in Hawaii since 1998, when the drug first started being marketed. It's estimated that the manufacturers made tens of millions in profits from those sales, including at the state's expense through Medicaid, Louie said.
Hawaii is the fifth state attorney general to file a lawsuit claiming unfair and deceptive marketing of Plavix, after Louisiana, Mississippi, West Virginia and California, said Richard Fried of the Honolulu law firm the attorney general's office hired to handle the lawsuit.
To work effectively, Plavix must be broken down by a particular liver enzyme. But the Food and Drug Administration says 2 to 14 percent of people in the U.S. have low levels of the enzyme, preventing them from successfully processing Plavix. The likelihood of being a non-responder varies by race, according to the FDA.
Plavix's "diminished effectiveness is especially prevalent among Hawaii consumers," the suit said.
According to 2010 Census data, Asians constitute nearly 39 percent of Hawaii's population; Pacific Islanders make up 10 percent; and nearly 24 percent of people in Hawaii are of mixed race.
Sanofi said last year that the U.S. Justice Department was investigating its disclosures to the FDA about different responses to Plavix. The company provided no additional details but said it was cooperating with the probe.
Date: March 20, 2014
Source: Associated Press