Profit Before Patients

By Bonnie Jenkins, Advanced Natural Medicine Bulletin

How much is enough? If you’re a pharmaceutical company, there’s never enough – at least when it comes to profits. And no other type of medication brings in as much profit as the cholesterol-lowering statin drugs. In fact, Lipitor (the most popular statin drug) rakes in a whopping $10 billion!

But apparently that’s not enough.

I’m sure the pharmaceutical industry was tickled pink when the guidelines defining healthy cholesterol levels were lowered three years ago to add another 36 million patients to the 15 million who qualify for statins.

Now doctors are actively growing the statin market. A recent article in the Annals of Internal Medicine suggests that all diabetics take statins, which would bring the tally to more than 50 million Americans, all hooked on this expensive – and dangerous – class of drugs.

Money honey

The article supports guidelines recently adopted by the Clinical Efficacy Assessment Subcommittee (CEAS) of the American College of Physicians. Under the new guidelines, doctors would prescribe statin drugs to their diabetic patients whether or not they had high cholesterol.

You might think this would have the CEOs at Pfizer, Merck and Bristol-Myers Squibb giggling with glee. But greed can never be satisfied. So they’ve come up with a new plan to increase statin sales. Offer them over-the-counter!

As outrageous as this idea may sound, there is a precedence. Based on a recommendation by “experts” from Britain’s Committee on Safety of Medicines, consumers in the UK will soon be able to buy a low dose (10 mg.) of non-prescription Zocor at any corner  drugstore.

And you can bet the U.S. will be the next big market to consider making statins more accessible to consumers.

Sure, the FDA rejected the idea when drug companies first brought up the idea of making Mevacor and Pravachol OTC drugs in 2000. At the time, regulators were concerned about safety – and rightly so. But things have changed. A recent budget request by the FDA under President Bush asked for $1 million for OTC drugs, touting them as an "effective means to reduce consumer prescription costs." Of course, this is just one of many signs that the FDA is warming to the idea of turning prescription drugs into OTC remedies. And if Merck gets its way, Mevacor will be the test balloon that will pave the way for other statins.

But to say this move will save consumers money is wishful thinking. If anything, patients will pay more out-of-pocket since insurance companies don’t cover OTC medications. And then there’s the question of safety.

Risky business

Unfortunately, statins do more than simply lower cholesterol. The same enzymes involved in the production of cholesterol are also required for the production of coenzyme Q10. So, while statins do lower cholesterol levels, they also reduce the body’s supply of  CoQ10. CoQ10 plays an important role in the providing energy to the cells, especially in the heart, and low levels are implicated in virtually all cardiovascular diseases, including angina, hypertension, cardiomyopathy and congestive heart failure.

The drug companies are well aware of this problem, as is the FDA. In 1990, Merck obtained a patent for Mevacor and other statin drugs formulated with up to 1,000 mg. of coenzyme Q10. The company then shelved the plans for this statin/CoQ10 combo – essentially preventing anyone from coming out with a similar product.

But the problems don’t stop there. Study after study has documented the risks associated with taking statins. Eye problems are not uncommon and researchers have linked the drugs to an increased risk of cataracts. More recently, statins were found to boost the incidence of ocular hemorrhaging (bleeding in the eye). And there is evidence that statins have a negative impact on immunity – one study by the University of Texas, Austin, found evidence that statins are toxic to white blood cells.

More frightening, statin drugs can cause rhabdomyolysis, a life-threatening condition that destroys muscle cells and releases them into the bloodstream, ultimately causing kidney failure. And statins can also damage the liver. Yet, the American College of Physicians specifically dismissed testing for muscle enzymes or routine liver function tests in patients taking statins.

Despite these serious side effects, conventional medicine and the drug companies continue to tout the effectiveness of statins – and they don’t limit their praise to cholesterol. Industry funded studies are currently looking into the possibility of using statins for multiple sclerosis, rheumatoid arthritis and even cancer. 

One last thing . . .

The latest temptation drug companies are dangling in front of our faces is statin drugs potential to prevent or treat Alzheimer’s disease. Some experts say that statins can cut the risk of developing the disease by up to 70 percent and studies are currently looking into that possibility. But, so far the evidence doesn’t come close to supporting the theory.

In fact, just the opposite may be true. An article in the March 2004 issue of the journal Dementia and Geriatric Cognitive Disorders notes that Alzheimer’s patients are particularly susceptible to the adverse side effects of statin drugs.

Researchers at the University of Pittsburgh also report that some statins can affect attention and reaction speed in non-Alzheimer patients. In their study, patients whose cholesterol had been lowered with Mevacor paid less attention and had delayed psychomotor reflexes compared with those who had not received the drug. Those who had the greatest decreases in cholesterol levels suffered the greatest impairment.

The bottom line: start with diet and exercise. If these common sense strategies aren’t enough to lower your cholesterol, look for safer, less expensive alternatives to statins, such as guggul, fenugreek or policolsanol. 

This just in . . .

Can a cuppa Joe keep you healthy? It just might. New findings by Professor Alan Crozier, a researcher at the University of Glasgow suggest that coffee is jam-packed with highly-absorbable antioxidants.

In his study, Dr. Crozier found that 75 percent of the antioxidants in coffee were absorbed into the bloodstream before they hit the lower end of the small intestines. As a comparison, only 30 percent of the antioxidants in green tea are readily absorbed. And what about the remaining 25 percent? They passed into the large intestines, leading Dr. Crozier to speculate that the antioxidants in coffee could also protect against colon cancer.

But don’t head to Starbuck’s just yet. Other studies have found that the chlorogenic acid in coffee can raise homocysteine levels. What’s the answer? If you drink more than two cups of coffee a day, make sure you’re taking 400 to 800 mcg. of folic acid a day to counterbalance the homocysteine factor.

References:

Algotsson A, Winblad B. “Patients with Alzheimer's Disease May Be Particularly Susceptible to Adverse Effects of Statins.” Dementia and Geriatric Cognitive Disorders 2004;17:109-116.

“Coffee could fight disease, colon cancer.” NutraIngredients. 7 April 2004.

Dixon K. “U.S. Could Be Next Market for OTC Cholesterol Drugs.” Reuters. 11 May 2004.

Fraunfelder FW. “Ocular Hemorrhage Possibly the Result of HMG-CoA Reductase Inhibitors.” Journal of Ocular Pharmacology and Therpeutics. 2004;20:179-182.

Pettit FH, et al. “Reversal of statin toxicity to human lymphocytes in tissue culture.” Drug Metabolism and Drug Interactions. 2003;19:151-160.

Snow V, et al. “Lipid Control in the Management of Type 2 Diabetes Mellitus: A Clinical Practice Guideline from the American College of Physicians.” Annals of Internal Medicine. 2004;140:644-649.