FDA correctly identifies risks from statins

Got across this disturbing article about statins.  For those taking Lipitor or Crestor, take a look at this article about their side effects:

What does a knee surgeon know about statins' side effects? Plenty, after seeing scores of patients improve their memory, strength, vigor and sex drive after stopping these popular drugs.

Statins — known by brand names such as Lipitor and Crestor — are prescribed to lower cholesterol. The U.S. Food and Drug Administration recently decided to require that statin labels include warnings about the rare but serious risk of liver damage, memory loss and confusion, and Type 2 diabetes. Certain statins — known by the generic, lovastatin — can also raise the risk of muscle weakness, which I've seen in my patients.

Many of them provide a list of their medicines that commonly hit double digits. One medicine that seems to appear on that list of most every patient older than 45 is a statin. Most patients tell me they experience joint or muscle pain, but few are aware that statins' side effect may be one reason for their symptoms.


Many believe lowering cholesterol will decrease their risk of heart attack and stroke, and allow them to live longer. But nothing could be further from the truth for most people. Patients frequently experience side effects and have simply been switched to another drug in the same category. Very few told me they were informed of the true absolute benefit or given other lifestyle options as a first line of treatment.

Additionally, when follow-up blood work shows decreasing cholesterol levels, rarely are statins discontinued or decreased. The usual recommendation is to continue statins for the rest of their lives, which amounts to an annuity for the drugmakers.

A recent Cochrane Review of many studies confirmed 1,000 people without heart disease had to be treated with statins to prevent one death. Therefore 999 people, paying $5 per pill, are not going to live one day longer, but they will enrich the pharmaceutical industry's coffers and are at risk for the many real side effects of stopping production of cholesterol — a wonderful molecule responsible for healthy cell membranes, sex hormones, nerve conduction and brain function, all of which contribute to life as we know it today.

Statins are not a miracle drug like penicillin, insulin or vaccines that truly altered mankind; statins are simply the most prescribed drug in the history of medicine and the most profitable, with annual revenues of $26 billion. Profits are so lucrative to "big pharma" that drug manufacturers have influenced most medical organizations and respected high-profile physicians to continue to look for every opportunity to exaggerate any new study that validates prescribing the highest dose of statins to an increasing patient population under the false assumption that it will improve their quality of life.

Any physician who would publicly state that the absolute benefit is more 1 percent to 2 percent to only a small percentage of people would face an insurmountable fight from the monumental propaganda machine financed with billions in drug profits, much of which come from taxpayers through guaranteed Medicare pharmaceutical benefits negotiated by big pharma to support Obama's health care law.

Make no mistake: Statins have real benefits, but only for a limited group of people, mostly men with documented heart disease and with only a small benefit. Most healthy people and all women without a history of heart disease will not live one day longer if they took statins daily for 30 years.

Ironically statins' true benefit has more to do with other, less lucrative and marketable anti-inflammatory and antioxidant effects than its cholesterol-lowering effect. And statins are a very expensive way to gain an anti-inflammatory effect, when a similar benefit could be garnered with aspirin, a healthy lifestyle, an anti-inflammatory diet, fish oil, Vitamin B and other natural products.

A final dirty little secret is statins' depletion of Co-Q 10, a vitamin-like substance in our cells important for energy production. Less Co-Q 10 is the main culprit behind muscle aches and pains and even weakening of the heart pump in patients with heart failure. How ironic those patients with congestive heart failure are given a medication that can make them worse.

How many patients on statins are given advice to take Co-Q 10 by their prescribing physicians? Sadly, very few in my experience. Similarly, many diabetics with neuropathy are made worse with statins.

The FDA was correct in identifying a risk that many were aware of for decades; in my opinion and experience, side effects' numbers far exceed those reported to the FDA, since hundreds of my patients over the years complained of fatigue, memory difficulties and weakness.

They were just relieved to have an improved quality of life once they decided to give up statins — against the advice of their prescribing physician.

More from here: http://www.mcall.com/opinion/yourview/mc-statin-side-effects-meade-yv--20120310,0,3367573.story

Merck fails to get FDA nod for new cholesterol lowering combo pill

For those using maintenance medication for their cholesterol, hope this drug can be approved soon.  Take a look at this news article by Dr Ananya Mandal, MD:


The U.S. Food and Drugs Administration (FDA) have rejected Merck & Co.'s new combination cholesterol drug, at least for now.

The length of delay in approval is not clear yet as the FDA has called for additional study data on the compound. It combines generic Lipitor (Atorvastatin), the top-selling drug of all time, with Merck's cholesterol medicine Zetia (Ezetimibe).

The experimental drug, still known only as MK-0653C, contains medicines that fight high cholesterol in two different ways to reduce risk of heart attack and stroke. Lipitor, known chemically as atorvastatin, is part of the widely used class of drugs called statins that reduce the amount of cholesterol naturally produced in the liver. Zetia or Ezetimibe, on the other hand, reduces the amount of cholesterol absorbed from the food the patient eats. Vytorin includes Zetia and an older statin, Merck's Zocor, also called simvastatin.

Sales of Vytorin and Zetia both were hurt when Merck in early 2008 finally released unfavorable results from a study. The study showed that Vytorin was no better at reducing plaque build-up in neck arteries than just Zocor, which had been available as a cheap generic since 2006. Zetia is protected by patent in the U.S. until 2017.

The Food and Drug Administration issued a so-called Complete Response Letter for the pill, asking Merck to submit more data. It was unclear what data would be required. Merck said Monday that company officials will talk with the FDA to determine the next steps, adding that some new data expected later this year may address the FDA's concerns.

Merck spokeswoman Pamela Eisele said that the FDA did not ask for any information about the ongoing study, called IMPROVE-IT, to test whether Vytorin lowers heart attack risk compared to Zocor. Instead, Merck’s statement appears to be referring to two ongoing studies of Lipitor and Zetia taken as single pills and the new combination pill Merck is testing.

More from here: http://www.news-medical.net/news/20120305/Merck-fails-to-get-FDA-nod-for-new-cholesterol-lowering-combo-pill.aspx