Taming healthcare costs: Think third class of drugs

Joe Graedon, pharmacologist, author, and syndicated health talk show host of "People's Pharmacy," is enthusiastic about future growth opportunities for pharmacists. He was very disappointed with the recent Food & Drug Administration decision denying Merck permission to market its statin drug Mevacor (lovastatin) over the counter.

At a January forum held in New York City and sponsored by the Healthcare Marketing and Communications Council (HMC) on the problems and opportunities in the pharmaceutical industry, Graedon had a message for the industry: "I want this industry to convince the FDA that it is not all or nothing," when it comes to the Rx-to-OTC switch. He admits this is a challenging mission, especially in the aftermath of the Vioxx firestorm, when the Food & Drug Administration came under intense scrutiny by critics who questioned whether it has been vigilant enough in policing the safety of drugs already on the market. But as healthcare costs continue to skyrocket, Graedon sees the creation of a third class of drugs deserving of a closer look.

JD Kleinke, medical economist, author, and IT executive, agreed with Graedon. He told the packed audience at the Union League Club, "We need to lay out the architecture for pharmacists dispensing a third class of drugs." He added that the pharmaceutical industry should have a huge interest in pursuing this avenue while also acknowledging that this vision for pharmacists requires a level of technology not yet in place. Pharmacists who are more accessible than physicians can monitor blood pressure, test glucose levels, and work in collaboration with physicians on risk management, he said.

British Health Secretary John Reid recently commented, "Pharmacists will ask people a series of questions and, where appropriate, offer a range of health tests to ensure that it is safe to issue this drug." Gillian Hawksworth, president of the Royal Pharmaceutical Society, added that the reclassification of simvastatin would "... provide a perfect opportunity to discuss other risk factors such as smoking, obesity, and diet with a customer. Most important, the public will benefit from access to primary prevention treatment without compromising on professional expertise and advice."

Graedon asserted that the FDA has long resisted this concept. "It insists on an all-or-none approach: For the agency, drugs are either safe enough for anyone to buy at a convenience store without a prescription, or they are so risky that only a doctor can guide their appropriate use." Pharmacists, he contended, could alert patients to potential complications or prevent dangerous drug interactions just as they currently do with prescription drugs. Furthermore, Graedon added, behind-the-counter sale by pharmacists would give patients greater access to many medications-and at a lower cost.

FDA officials have said they believe it would take a change in federal law to restrict sales of certain medications to pharmacists, although they would be checking with their attorneys to be certain. Several panel members on the FDA advisory committee, reviewing Merck's application, said they would like to see an in-between option by which patients can buy the drug without a prescription but only after speaking with a pharmacist. However, the application by Merck for Mevacor asked for freely available, over-the-counter sales, so that is what was considered.

Both Graedon and Kleinke said that many countries would be monitoring the performance of OTC Zocor in the UK closely. They expressed their hopes that the FDA would consider this model in the future.