- The Washington Times - Friday, May 11, 2001

When an FDA advisory committee holds a hearing today on a petition by HMOs to have prescription allergy drugs sold over the counter, it will be a case of the pill splitters vs. the gene hunters.
HMOs and insurance companies are tired of paying for such allergy medications as Claritin as well as other new drugs. Their most recent attempt to save money was to send their customers pill splitters. Pill-splitting is the practice of prescribing and dispensing a double dose for patients, and then telling them to split the tablet to get the required dose.
Unfortunately, according to Jann Skelton, director of professional practice development for the American Pharmaceutical Association, "some of these pills are incredibly tiny… . If you have perfect eyesight and perfect dexterity, you might be lucky enough to split it down the middle." Mr. Skelton also notes that "pill splitting is generally not accurate … you have folks that are fluctuating doses, which could cause changes in their overall treatment."
Pill splitting is obviously not in the best interest of patients. But neither is an over-the-counter petition filed by Wellpoint HMO, the first such petition filed by a health plan. A lot of observers see the petition merely as a money-saving move. If allergy medicines are given non-prescription status, HMOs dont have to reimburse people for their cost. Thats precisely why European and Canadian health systems famous for their rationing of new medicines have taken such medications over the counter. But in the case of filing for OTC status, an FDA approval also would be a blow against medical progress, and the first casualty would be the quality of asthma care.
According to Dr. Leonard Bielory, head of the Department of Asthma and Immunology at the University of Dentistry and Medicine of New Jersey, taking allergy medicines over-the-counter would compromise patient care, by taking the doctors out of the process of managing allergies, which are an important trigger for asthma.
Irwin Redlener, chairman of the Childrens Health Fund, which runs an asthma management program in the South Bronx for homeless and poor kids, is concerned there would be increasing self-diagnosis and treatment for problems that just arent what they seem to be. This is precisely what the HMOs are hoping for. If patients dont walk into an HMO, they dont bother the bottom line, right?
Second, the OTC shift would be a forced taking of intellectual property and patent life from companies such as Schering-Plough, Pfizer and others. If the FDA grants HMOs their petition, it would establish the precedent that any group could, for their own financial reasons, seek to eliminate a drugs patent life by taking a drug to nonprescription status. The Health Insurance Association of America the trade group that now represents HMOs and is in a loose alliance with the American Association of Health Plans has warned about the tidal wave of new biotechnology drugs that will hit the market in the next few years. What better way to fight the flood than to argue that because so many people take so many of these drugs so often, they should be stripped of patent protection and sold OTC?
Ultimately, the HMO endgame is about diverting dollars and resources away from innovation and into their own coffers. And they have been shrewd about picking on relatively uninspiring targets. For example, Schering-Ploughs allergy drug Claritin has become the poster boy for whats wrong with the pharmaceutical industry. It is supposedly a me-too drug that does not deserve any additional patent life. It is only profitable and popular because it is heavily marketed and paid for by third parties.
And yet it must be said that if it werent for Claritins profits, Schering-Ploughs research into the genetic underpinnings of hepatitis C would not be possible. Nor would a more recent discovery that few in the media in their effort to demonize the company bothered to report. A team of scientists at Southampton University, working for drug-maker Schering-Plough and Genome Therapeutics discovered a single gene that could account for as many as 40 percent of all asthma cases. Dr. Stephen Holgate, who led the research said, "In the 25 years since I have been doing asthma research, this is the biggest discovery thats been made. Its going to change the whole way we look at the disease."
It turns out that Schering-Plough provided all the cash for the entire gene-hunting operation. The cash, of course, came from sales of that terrible drug Claritin. There are no guarantees, but if all works out as hoped, there will be a tidal wave of new drugs and tests flowing from this single gene. That could be another reason why Wellpoint and other HMOs want to limit patent life and reduce the revenues of pharmaceutical firms in any way possible. Think of that the next time your HMO sends you a pill-splitter in the mail.

Robert M. Goldberg, senior fellow, National Center for Policy Analysis.

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