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The Center for the Biology of Chronic Disease

FDA Needs New Paradigm; Statins Latest Example

The FDA is adding new safety warnings to statins about memory loss and diabetes. The Center for the Biology of Chronic Disease (CBCD) is not surprised.

The FDA is adding new safety warnings to statins about memory loss and diabetes. The Center for the Biology of Chronic Disease (CBCD) is not surprised.

The FDA said Tuesday that it is making changes to the labels of Lipitor (Pfizer), Crestor (AstraZeneca), and Zocor's (Merck). These drugs are used by millions to lower cholesterol levels. 

Patients have reported memory loss and confusion for quite a while. In general, it went away after they stopped taking the drugs. However, the CBCD asks why the FDA is late in adding these new safety warnings.

Already, statins as a class of drugs have many side effects. In a series of trials, statins increased the risk of an adverse effect by 39% compared to placebo. [1]
These include raised liver enzymes and muscle problems. In randomized clinical trials, reported adverse effects are low; but they are "higher in studies of real world use", and more varied. [2]

And now, the FDA is adding more warnings to these drugs?

Amy Egan, deputy director for safety in the FDA's Division of Metabolism and Endocrinology Products, said in a statement, "The value of statins in preventing heart disease has been clearly established. Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects."

According to the FDA the benefits of statins is "indisputable." The CBCD would like to dispute this.

The CBCD points out that taking statins might be replacing one indication with another. For instance, should a patient trade heart disease for type 2 diabetes or memory loss?

It appears that the FDA is not calling a spade a spade, and as can be seen below ... neither is the medical profession.

According to ABC News, Dr. Kevin Marzo, chief of cardiology at Winthrop-University Hospital in New York said, "Patients should not see this as a new danger with the drugs, but as a known abnormality that appears in blood testing and should be discussed with their doctor." [3]

Memory loss is not an abnormality that shows up in blood tests. In the CBCD's opinion, Doctor Marzo's statement is simply wrong and is not helping patients understand the health tradeoffs presented by statins.

In point of fact, the CBCD believes these new warnings by the FDA are worrisome.

Like the Romans, the CBCD believes that knowledge is power. Statins inhibit the enzyme HMG-CoA reductase, which plays a central role in the production of cholesterol in the liver. Statins are an example of current pharmaceutical thinking and the FDA's paradigm. That paradigm involves designing drugs that inhibit or stimulate one enzyme/protein/hormone and hoping that this enzyme/protein/hormone is involved in a single bodily system.

No such enzyme/protein/hormone exists.

This means that every drug approved by the FDA will have serious side effects, some immediate, some delayed, some easily seen, others never recognized. The current paradigm of drug development and approval is flawed, costly, and the public pays the price, with their health.

In contrast with the current paradigm, the CBCD proposes the adoption of Microcompetition, a theory that identifies the origin of many chronic diseases. Such diseases include atherosclerosis, multiple sclerosis, stroke, cancer, obesity, diabetes, lupus, thyroiditis, osteoarthritis, rheumatoid arthritis, and alopecia.

When doctors treat a symptom, such as lowering cholesterol, they aggravate or create all new symptoms elsewhere in the body such as memory loss and diabetes. In contrast, when doctors will treat the origin of the disease they will not only cure it, but also cure other seemingly unrelated diseases.

The CBCD encourages the FDA, doctors, biologists, virologists, and scientists to obtain a copy of "Microcompetition with Foreign DNA and the Origin of Chronic Disease" written by Dr. Hanan Polansky.

The CBCD believes Dr. Polansky's findings may indeed be a huge blow to the paradigm held by the FDA and the entire pharmaceutical industry.

The book is available as a free download from the CBCD website.  (http://www.cbcd.net )

"I found that the theory is groundbreaking and will likely open doors to many exciting research areas and treatment options ... biology and medicine lag behind and remain experimental disciplines, which are heavy on experimental data but thin on applicable theories that could guide future directions. In this sense, Dr. Polansky's book is nothing short of revolutionary." - Liqun Zhang, PhD - Research Associate, Cystic Fibrosis/Pulmonary Research and Treatment Center, University of North Carolina at Chapel Hill

The CBCD endorses Dr. Polansky's theory and invites scientists and the media to contact us for dialogue regarding the theory.

For more information on the Center for the Biology of Chronic Disease, or to schedule an interview with Dr. Polansky on the subject of Microcompetition with Foreign DNA, please visit http://www.cbcd.net or call 585-250-9999.


[1] Silva MA, Swanson AC, Gandhi PJ, Tataronis GR (January 2006). "Statin-related adverse events: a meta-analysis". Clin Ther 28 (1): 26-35.

[2] Golomb BA, Evans MA (2008). "Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism". Am J Cardiovasc Drugs 8 (6): 373-418.

[3] http://abcnews.go.com/Health/wireStory/fda-adds-safety-information-statin-drugs-15810408#.T1S5JnnpdaE


About the CBCD

The Center for the Biology of Chronic Disease (CBCD, http://www.cbcd.net) is a research center recognized by the IRS as a 501(c)(3) non-for-profit organization. The mission of the CBCD is to advance the research on the biology of chronic diseases, and to accelerate the discovery of treatments for these diseases.

The CBCD published the "Purple" book entitled "Microcompetition with Foreign DNA and the Origin of Chronic Disease" written by Dr. Hanan Polansky. The book presents Dr. Polansky's highly acclaimed scientific theory on the relationship between the DNA of latent (chronic) viruses and the onset of chronic diseases. Dr. Polansky's book is available as a free download from the CBCD website.

We invite biologists, virologists, and scientists everywhere to download Dr. Polansky's book here: http://www.cbcd.net/.



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