Doctors are doubling down on their
right to be wrong and do more harm to patients. With
Rosuvastatin/Crestor the only statin still under patent, all of the
other statins have lost patent protection, and so the world has
changed. It is now cheaper to use the generic statins and doctors
now feel that the benefits of low cost far outweigh the harms caused
by statins. These doctors are promoting statins for more of the
population and this means that the complications of statins will be
affecting more people.
Recommendations now state that statins,
which decrease low-density lipoprotein (LDL) cholesterol, may be
prescribed if lifestyle changes aren’t enough. In 2013, the
American College of Cardiology and American Heart Association, in
collaboration with NIH’s National Heart, Lung, and Blood Institute
(NHLBI), released new clinical practice guidelines on cholesterol
treatment to reduce ASCVD (atherosclerotic cardiovascular disease)
risk. Among the recommendations was that people 40 to 75 years of
age without clinical ASCVD and diabetes should take statins if they
have an LDL cholesterol level of 70 to 189 mg/dl and an estimated
10-year ASCVD risk of 7.5% or more. The guidelines also included
methods for making this risk estimate.
A group led by Drs. Ankur Pandya and
Thomas A. Gaziano at the Harvard T.H. Chan School of Public Health
developed a computer model to project the lifetime health outcomes
and cardiovascular disease–related costs of 1 million hypothetical
U.S. adults. They used data from the nationally representative
National Health and Nutrition Examination Survey (NHANES) and several
other published sources.
The team found that the health benefits
conferred by the current ASCVD risk threshold of 7.5% or higher were
worth the incremental costs, according to commonly accepted
“willingness-to-pay” public health standards. Lowering the
threshold for statin treatment to 3% or 4% could avert another
125,000 and 160,000 cardiovascular events, respectively. Depending on
assumptions about benefits and risks, these risk thresholds might
also be considered cost-effective options. These estimates can help
inform future decisions about balancing costs with quality years of
life.
A group led by Dr. Udo Hoffmann at
Massachusetts General Hospital and Harvard Medical School studied
whether the new guidelines improved the efficiency and accuracy of
the previous ones. The group drew on data from nearly 2,500 adults
in the Framingham Heart Study. Participants underwent testing to
detect coronary artery calcification, an early sign of coronary
artery disease.
About 39% of the participants were
eligible to receive statins under the ACC/AHA guidelines, compared to
14% under the previous 2004 guidelines. The new guidelines proved
more accurate and efficient at identifying people at increased risk
of both cardiovascular disease and subclinical coronary artery
disease. The findings were consistent for men and women. They were
particularly important for people at intermediate risk, for whom
deciding when to begin statin therapy is challenging. The
researchers estimated that between 41,000 and 63,000 cardiovascular
events would be prevented over a 10-year period by adopting the
ACC/AHA guidelines compared to the previous guidelines.
The new cholesterol treatment
guidelines have been controversial, so our goal for this study was to
use the best available evidence to quantify the tradeoffs in health
benefits, risks, and costs of expanding statin treatment. We found
that the new guidelines represent good value for money spent on
health care, and that more lenient treatment thresholds might be
justifiable on cost-effectiveness grounds even accounting for side
effects such as diabetes and myalgia.
Now we have Big Pharma and a new class
of drugs for treatment of LDL called Praluent (PSCK9), which in the USA has been
limited by the FDA to treat only people at extreme risk for heart
disease from cholesterol. Not that this will slow things as these
doctors will just elevate the number of people at high risk and
prescribe the drugs anyhow.
In addition, the
side effects of Praluent include itching, swelling, pain or
bruising at the injection site, nasopharyngitis and flu. Allergic
reactions, such as hypersensitivity vasculitis and hypersensitivity
reactions requiring hospitalization, have been reported. Please
read this blog by Dr. Malcolm Kendrick for more information on the
drug class PSCK9.
If you would like to do more research
about statins, I suggest you read the Great Cholesterol Con by Dr.
Malcolm Kendrick. This is important if you even think that doctors
are doing you a favor by prescribing statins to you.
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