Some of the world’s biggest drug companies are working behind the scenes to convince regulators to let older cholesterol-lowering drugs be sold without a prescription in low doses, as Britain has just done.
While doctors say the drugs are safe, less than one-half of Americans who could benefit take them, mostly those at highest risk of heart disease, other complications and death, experts say. Most of the 18 million at moderate risk, defined as having a 10 percent to 20 percent risk of such problems over the next decade, are not on medication.
“What we’re proposing with over the counter is, let’s treat that 10 to 20 percent (group),” said Jerry B. Hansen, vice president of marketing for Johnson & Johnson-Merck Consumer Pharmaceuticals Company, a joint venture seeking FDA approval for a low-dose, nonprescription version of Merck’s Mevacor, the first statin drug.
The added publicity also could drive more people at high risk to their doctors.
Hemant Shah, an independent pharmaceutical analyst with HKS & Co. in Warren, N.J., expects it would significantly expand statin use by people at mild to moderate risk without stealing sales from newer cholesterol drugs such as Lipitor, Zocor and AstraZeneca’ Crestor, because they are much more powerful and will be used by higher-risk patients.
But Dr. Sidney Smith, past president of the American Heart Association, worries that some patients won’t see a doctor regularly and address all their risk factors, including high blood pressure, smoking, diabetes, diet, exercise level and weight.
I still think it’s inevitable that OTC status is coming. As DB stated in his blog, it’s all about the money. Savings for insurance companies, continuing profit for the drug companies. With some reservations, I agree that OTC status will be beneficial to the public, encouraging those who should be on these medications to do so.
There will be many who believe that these medications would be a “quick fix” for lifestyle modification (i.e. those who pop a pill after a steak). Instead of wondering if it’s going to happen, we should start focusing on educating the public on the changes that potential OTC cholesterol medications will have on their lives.