Fresh from passage of Medicare Part D, the K Street lobbyists have written a blockbuster how-to book, Making Government Your Lackey. This tell-all will tell all about the strategies that turned government from protector of the people to corporate lackey -- not even a veiled lackey, but a proudly subservient one that proclaims the public interest even as it fills corporate coffers. Medicare Part D is a case in point: It enriched Big Drugs and Big Insurers while giving would-be beneficiaries an expensive headache.
Medicare Part D, though, has its downside. The clamor from unhappy constituents surely dampened solons' enthusiasm for the corporate benefactors behind that endeavor. Although corporations fuel campaigns, voters decide elections; and Medicare Part D has spawned voter rage. From K Street's vantage, such unpopular success has its risks.
A more successful chapter in this primer will focus on Off-Label Marketing. No glitz there. The tale has attracted little public attention. Yet off-label marketing is lucrative. Indeed, its off-the-radar success makes it a perfect case.
The tale -- and the opportunity -- of off-label marketing begins in the innards of the Food and Drug Administration. A manufacturer needs FDA approval to market a drug; and the FDA demands evidence from years of clinical trials on all species, especially humans, before giving the company the green light to fill pharmacies with its miracle-product. That FDA screening marks the public's protection. Even ultraconservative legislators would not want a Wild West world without the FDA, where manufacturers tout their potions, citing whatever evidence they choose. When the public sees drug X advertised for a specific condition, the FDA has given its approval.
Once the drug is on the shelves, though, a physician can prescribe it for another condition. The FDA doesn't dictate to physicians: A physician can give a patient with condition B a drug that has been approved for condition A. Anecdotal evidence often supports the decision. Indeed, many drugs are in clinical trials for "off-label" conditions and in time these drugs might gain FDA approval for that condition.
Enter the K Street lobbyists. Companies are advertising drug X for condition A. The FDA prohibits a company from advertising that drug for other conditions -- but physicians can prescribe it. The challenge -- no, the opportunity -- is to "educate" physicians about the possibilities of the new drug. Education is okay; influence isn't. So why not educate physicians to prescribe that drug for conditions B, C and D? The line between education and influence wavers: Lobbyists help delineate it.
Consider thalidomide. The drug caused birth defects in the 1960s -- and spurred the FDA to bar unproven drugs from sale in the United States. In 1998 thalidomide found its way back into pharmacies when the FDA approved it for a condition akin to leprosy.
A sliver of the American populace, however, will get this condition. No great profits there. If thalidomide worked for other conditions, there might be enough of a market to make a profit.
There was. Clinicians discovered that it might help patients with multiple myeloma. Soon eager company "educators" were touting the drug to physicians, not just for myeloma, but for weight loss, even for boosting mood. By 2003, 1% of the sales were for the leprosy-like condition; 70% were for multiple myeloma. The FDA is now reviewing the company's application for thalidomide as a treatment for myeloma; there is no application, with accompanying data, to justify its use for other conditions.
Thalidomide is not unique. More than half the drugs sold are intended for "off-label" uses.
As profits have grown, so has "education." The Senate Committee on Finance, under Sens. Charles Grassley (R-Iowa) and Max Baucus (D-Mont.), just heard testimony that in 2004, 23 drug companies spent $1.47 billion on "education grants" -- 20% over that spent in 2003. One much-touted drug was Propulsid, approved to treat heartburn in adults, but widely prescribed as a remedy for childhood reflux -- and withdrawn in 2000 after several patients died.
The FDA could oversee off-label "education," delineating education from marketing. It has the capacity to cite companies for egregious sales pitches. If a drug is being widely prescribed for an off-label use, the FDA can ask for supporting evidence. But the FDA's regulatory zeal has ebbed. K Street lobbyists deserve the credit.
Joan Retsinas is a sociologist who writes about health care in Providence, R.I. Email retsinas@verizon.net.