A congressional investigation of the money that drug companies give as supposed educational grants has found that the payments are growing rapidly and are sometimes steered by marketing executives to doctors and groups who push unapproved uses of drugs.
Twenty-three drugmakers spent a total of US$1.47 billion in 2004 on educational grants, or an average of US$64 million per company, according to the Senate Finance Committee. That number was a 20 percent increase from the total in 2003, which was US$1.23 billion.
The committee did not estimate what percentage of those grants were instead used for marketing purposes. But in a letter sent on Monday to Johnson & Johnson, the committee suggested that the use of educational grants to further marketing aims was widespread in the industry. The committee also sent letters to most other major drug makers this week, seeking more information about their use of educational grants.
The investigation is being directed by Senator Charles Grassley, an Iowa Republican, and Senator Max Baucus, a Democrat from Montana, who are the chairman and ranking minority member, respectively, of the powerful investigatory committee.
"It's hard to see how you could call some of these grants `educational,'" Grassley said in a recent interview.
Baucus added, "If drug companies are crossing the line with these grants and influencing providers to make treatment decisions they might not otherwise make, that's a problem and we're going to tackle that."
The investigation is part of a growing reassessment by federal legislators and prosecutors of the ways that drug makers are said to encourage doctors to prescribe medicines for uses not approved by federal drug regulators.
Although doctors are allowed to prescribe federally approved drugs for any purposes they see fit, companies are allowed to market drugs only for their specifically approved uses. But in years past, at least, drugmakers have given grants to doctors, medical societies and patient groups that do promote unapproved, or off-label, uses.
There is no doubt that off-label use of drugs is big business for the pharmaceutical industry. It has been estimated that more than half of all prescriptions written nationwide are for off-label uses.
Food and Drug Administration regulations have long allowed drug companies to give educational grants to individuals or groups that discuss or promote off-label uses. But in recent years, federal prosecutors have been investigating whether these activities have strayed beyond educational purposes and violated anti-kickback statutes or resulted in the government's spending money in its Medicare and Medicaid health programs for prescriptions that were not warranted.
In one example cited in the committee's letter, Johnson & Johnson in 1999 provided an "educational" grant to pay for an alumni reception at the annual meeting of a medical specialty society.
That grant was provided at the request of a physician who had previously received grant money for research and educational activities related to Propulsid, a Johnson & Johnson drug that was withdrawn in 2000 after it was found to cause potentially fatal heart arrhythmias. Although Propulsid was approved only to treat severe heartburn in adults, it ended up being widely prescribed for off-label use by children.