New Drugs And Risks

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FDA Approves Two Drugs That Will Make Millions For Manufacturers But Will

Predictably Pose Risks To Consumers

 

 

One drug approved, another pending, and few Americans are likely to be any

healthier. The Food & Drug Administration, under pressure by industry to approve

prescription drugs in a more expedient fashion so as not to raise costs to

manufacturers and consumers, has become a rubber-stamp arm of government. Most

of the drugs the FDA approves today work better than a placebo tablet, but not

necessarily better than existing therapies. Pharmaceutical companies often do

not disclose what they use as an inactive placebo tablet so as to reduce the

comparative side effect rate between active drug and placebo. This makes the

drugs look better than they are in the real world. Many drugs that have achieved

FDA approval have done so via rigged studies.

 

Without much fanfare, the US Food & Drug Administration approved the

cholesterol-lowering drug Crestor (rosuvastatin) on August 12, 2003. Crestor

(AstraZeneca) does a better job of lowering a particular type of " bad "

cholesterol called LDL-C (low-density lipoprotein-C) than other statin drugs

like Lipitor. The drug was approved after evaluation of studies that only lasted

a few weeks, not long enough to reveal any long-term side effects. Muscle aches

and weakness were reported in these short-term studies, which are overt signs of

possible rhabdomyolysis, a potentially mortal drug side effect that degrades

muscle tissue which can clog the kidneys and can cause death. [FDA Talk Paper

T03-61, August 12, 2003]

 

Move over Lipitor. At a 40 milligram daily dose, Crestor reduces LDL-C a

remarkable 63%, lowers total cholesterol 46%, and raises " good " HDL cholesterol

by 10%. However, it accomplishes this by being more toxic to the liver, the

organ that manufactures cholesterol. Statin drugs deplete the body of coenzyme

Q10, an essential antioxidant, and often raise liver enzymes, a sign of a

dysfunctional liver.

 

Most of the people taking statin drugs this writer encounters state they have

had bouts of muscle soreness but have no idea this a serious sign. Yet the

manufacturers claim very low side effects. The long-term safety studies for

Crestor were only conducted on animals for 107 weeks. The adverse reaction rate

was 3.0 to 3.7%, most being characterized as mild or transient, yet data was

only collected for 12 weeks. [AstraZeneca product description 08/03] At higher

than human doses, animals did develop increased number of uterine polyps and

carcinoma of the liver. Two studies indicate statin drugs raise the lactic acid

levels surrounding cells in the body. [british J Clin Pharm 42: 333-37, 1996;

Clin Pharmacol 72: 461-64, 2002] The scary problem is that cancer cells also

release more lactic acid.

 

Another widely acclaimed statin anti-cholesterol drug was approved in a similar

manner to Crestor. It was Baycol, which was withdrawn from the marketplace after

it as linked with 52 deaths. [Therapie 58: 77-83, 2003] Crestor is an even more

powerful drug than Baycol, so the public can anticipate future reports of

serious side effects, and a possible recall. The approval of Crestor was delayed

about 2 years after the Baycol problems.

 

Another drug the FDA intends to approve in September 2003 is Seasonale (Barr

Laboratories), which is an extended-cycle oral contraceptive. Women's cycles

would be delayed for 84 days and only 4 menstrual periods would be experienced

annually. For the sake of convenience, women will give up their natural immunity

against disease. Women, by virtue of their monthly loss of blood, maintain iron

levels about half that of males and exhibit half the rate of diabetes, cancer,

infections and heart disease compared to men. [American Heart Journal 145:190-4,

2003] There is no mention for women to avoid iron supplements, or highly

iron-fortified foods, when taking Seasonale. Expect the rates of disease in the

population of American females to rise with the popularity of Seasonale.

 

Copyright Bill Sardi 2003

Knowledge of Health, Inc.

Copying for individuals is permitted.

 

 

 

 

Copyright 2003 Knowledge of Health.