First OTC Cholesterol Drug Launched
Issue219 Item 8

U.S. might be close behind. Britain became the first country in the world to sell a cholesterol-lowering drug without a prescription on Thursday when a low-dose "over-the-counter" (OTC) form of Merck & Co Inc’s Zocor was launched.

The new version of Zocor (simvastatin) will be marketed by Johnson & Johnson MSD under the brand name Zocor Heart-Pro at a cost of 12.99 pounds ($23.58) per 28-day pack.

In a ground-breaking move in May, the British government approved the switch from prescription to over-the-counter status, arguing that easier access would allow more people to protect themselves from the risk of coronary heart disease.

Many doctors have voiced concern about the decision, which they contend will result in some people taking the medicine who do not need it while others could receive an inadequate dose.

The 10-milligram daily pill is designed for people at moderate risk of heart disease, defined as those with a 10% to 15% risk of a heart attack in the next 10 years.

This group could total around 7.4 million, according to J&J MSD, and includes all men over 55 as well as men over 45 and women over 55 who are overweight, smoke, have a family history of heart disease or are of South Asian origin.

Pharmacists will be able to sell Zocor Heart-Pro to customers after asking about their situation and offering various health tests to ensure it is safe to give them the drug. A cholesterol test will be offered but is not compulsory.

The OTC move is expected to help reduce the state’s drug bill significantly, since Britain’s National Health Service spends more than 700 million pounds on such products each year.

The success of the scheme in Britain will be monitored closely by drug regulators around the world, who are under pressure from governments to make more medicines available OTC to reduce healthcare costs.

In the United States, Zocor has patent protection until 2006 and Merck is focusing there on seeking OTC status for an older statin called Mevacor.
===============================
FACT: Avandia and Actos Being Used for Psoriasis Treatment: glitazones are also being tested for other inflammatory conditions such as asthma…atopic dermatitis… multiple sclerosis…and ulcerative colitis. This benefit was first seen when some patients noticed that their psoriasis improved after starting a glitazone for diabetes. Now preliminary studies suggest that Avandia (rosiglitazone) or Actos (pioglitazone) can help psoriasis in patients WITHOUT diabetes. Glitazones improve insulin sensitivity by activating peroxisome proliferator-activated receptors (PPARs). PPARs are a hot area of research. You’ll hear more about them in the years ahead. These are receptors in cell nuclei. Activating PPARs seems to have anti-inflammatory and immune-modulating effects. Don’t be surprised if you see a dermatologist prescribe Avandia or Actos for psoriasis. Tell patients they don’t need to worry about hypoglycemia. Glitazones by themselves don’t cause hypoglycemia. Arch Dermatol 2000; 136:609-16.
Arthritis Rheum 2002;46:598-605