Posted on 05/15/2004 1:18:39 AM PDT by neverdem
ONDON, May 14 — Britain will become the first country in the world to sell a cholesterol-reducing drug, called a statin, without a prescription.
Starting in July, a low dosage of the drug Zocor will be sold over the counter to people at moderate risk of heart disease, a number that could reach 5 million to 10 million. That group includes all men older than 55, as well as men over 45 and women over 55 who smoke, are overweight, have a family history of heart disease or come from the Indian subcontinent, all groups that are at higher risk than the general population.
The customer is expected to fill out a questionnaire at the pharmacy before buying the drug and may be encouraged, but not required, to take a cholesterol test.
The drug, made by Johnson and Johnson MSD, will be sold in monthly packets, to be taken at doses of 10 milligrams a day, and is expected to cost £12 to £15, or about $21 to $26, per pack, said Paul Jarman, a spokesman for the company. That is about £9, or $15, more than it costs National Health Service patients.
The decision to broaden the availability of statins is expected to curb the rate of coronary disease in Britain, which kills 100,000 people in England alone and costs the National Health Service a substantial sum in treatment. Studies have found that statins can help fight heart disease by lowering levels of "bad" LDL, or low-density lipoprotein, cholesterol.
As it stands now, only those at moderately high risk of heart disease can get a prescription for statins from their doctors; statins are taken by 1.8 million people here, making them the most widely prescribed drug in Britain. The drugs cost the government about $1.2 billion a year.
John Reid, the health secretary, said that experts believed hundreds of deaths a year may be prevented by offering low-dose statins over the counter. The Committee on Safety of Medicines, which recommended the switch to over-the-counter sales, said the benefits of selling Zocor without a doctor's permission outweigh the risks.
"By extending access to this drug, we are giving people more choice about how they protect their health," Mr. Reid said, in announcing the change. "We are committed to extending choice whenever advised it is safe to do."
But the decision to permit the sale of simvastatin, marketed as Zocor, has divided the medical community and angered consumer rights organizations that say too many questions remain unanswered.
Dr. John Chisholm, chairman of the British Medical Association's general practitioners committee, said there were concerns about possible side effects and appropriate dosages, particularly for people suffering from heart disease who may need higher doses and not know it.
Consumer rights groups say there are no solid clinical trials showing that statins help people at moderate risk of heart disease. Other critics say pharmacists should have access to customers' medical histories. And some wonder whether the drug will encourage risky behavior, like smoking, if people believe they are inoculating themselves against heart attacks.
Dr. James Kennedy, a spokesman for the Royal College of General Practitioners, said one major concern is the two-tier system the government is now creating between those who can afford preventive medicine and those who cannot. The poor, a category of people generally most threatened by heart disease, will not be able to buy the drug. Yet they will only qualify for a prescription if they are at high risk.
"This is the first time that in our state health service, funded out of general taxation, the cost of a large preventive drug has been shifted onto the individual patient," Dr. Kennedy said. "That is a huge departure from the National Health System."
At least for now, Zocor will be the only statin available in British pharmacies. Johnson and Johnson MSD applied for permission to reclassify the drug, which ran out of patent protection last year, for over-the-counter sales. The switch was approved by the government, after consultation.
Other companies, including Merck in the United States, are also working on getting over-the-counter approval for their statins in the United States and other countries.
Dr. John LaRosa, a nationally recognized expert on statins, said Britain's decision was a significant step in the prevention of heart disease despite the concerns, which he called reasonable. Preventive efforts by doctors and governments to help stymie heart disease have not been nearly as successful as they could be, he said.
"There is a significant percentage of people who should be getting treated with statins who are not getting treated for one reason or another," said Dr. LaRosa, president of the State University of New York Downstate Medical Center. "You can make an argument that something is better than nothing."
The drugs, with few exceptions, have been proven safe and beneficial to the "overwhelming majority of the patients who take them," he said.
On balance, he added, "They are much safer than aspirin.
PING
I don't think this is wise either. How are people going to know if they even need this? Or that they still need it after finishing another drug? I have customers come in and ask me about cholesterol stuff and their own diagnosis is based on how fat they are.
bttt
To my knowledge it has never been proven that lowering your cholesterol by using this drug reduces your chances of heart problems at all.
This is a bad, bad, bad idea.
I was hesitant to accept the cholesterol hypothesis for explaining coronary artery disease(CAD) initially. There have been many large, well done studies in the last ten years that support the use of statins to reduce mortality and morbidity from CAD.
Check out PubMed at the following URL:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
Use "statins AND (mortality OR morbidity)" or "statins AND CAD" as search strategies, just as you see how I wrote them, but without the quotation marks. Left click on limits, and then left click on "articles with abstracts". You may also want to limit the search to "review" in types of articles and language.
My problem stems from the fact that this policy of "over the counter" availability ignores the serious adverse effects which I mentioned in comment# 1 that occur in about 3% of the population, IIRC, and should be taken under the supervision of a physician IMHO.
BTW, it is believed that statins also have a beneficial anti-inflammatory effect with respect to CAD in addition to the effect on cholesterol levels. These effects are also thought to apply to the type of stroke in which the blood supply is obstructed.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.