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. 
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
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." 
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
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
The book is available as a free download from the CBCD
"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
The CBCD endorses Dr. Polansky's theory and invites
scientists and the media to contact us for dialogue regarding
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.
 Silva MA, Swanson AC, Gandhi PJ, Tataronis GR (January
2006). "Statin-related adverse events: a meta-analysis". Clin
Ther 28 (1): 26-35.
 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.