Yet, close to 800,000 prescriptions for the drugs are written each week in the United States, bringing in close to $4 billion for the year.
The companies have responded to cardiologists’ concerns over the lack of safety data for the drugs by promising to publish only a portion of the results in March, a move that critics are calling highly unusual.
Currently, no one knows whether Zetia and Vytorin are as effective as other cholesterol-lowering medications called statins. If they turn out to be less so, patients may be unnecessarily at risk of heart attacks.
Zetia was approved by the U.S. Food and Drug Administration in 2002 because it was found to lower LDL cholesterol by 15 to 20 percent. Vytorin combines Zetia with Merck’s statin drug, Zocor.
Together, the drugs have acquired close to 20 percent of the U.S. market for cholesterol-lowering drugs.
However, because Zetia and Vytorin work differently than standard statin drugs, cardiologists have expressed concerns that they may not protect the cardiovascular system as much as using a statin does.
Drugmakers Changed the Trial’s Endpoint
Along with announcing that they will only be releasing part of the clinical trial’s results, Merck and Schering-Plough said they had changed the trial’s endpoint, or the final result the study was supposed to measure.
Typically, the trial’s endpoint is supposed to remain constant because otherwise the study’s authors could change their goals to conform to the data they received.
The delay in publishing the study’s results raise further questions as to whether the drug industry is improving their disclosure of clinical trials.
Two years ago drugmakers promised to disclose study results publicly, however they face few penalties for failing to do so. It is a common trick of the drug cartel to overwhelmingly make public only the positive results to their clinical trials. And if it doesn’t look like you’re going to get any positives, well then you just change what you were looking for (which could easily be the purpose behind Merck and Schering-Plough’s decision to change their trials endpoint).
But the thing that gets me the most riled up is the blatant fact that millions of Americans have been taking these drugs, and paying for the privilege, without any solid evidence whether they’re truly effective (let alone what the real risks are).
The cardiologists referred to in the New York Times article are right to express concern over prescribing drugs that may or may not work. But they missed the boat in comparing these newer cholesterol-lowering drugs to their “gold standard,” the statins. In reality, neither drug is the answer.
PLEASE Understand -- Drugs are Not Your Answer to High Cholesterol
It may surprise you to learn that cholesterol is not the major culprit in heart disease or any disease. It may surprise you even more to learn that the guidelines that dictate what number your cholesterol levels should be to keep you “healthy” are fraught with conflict of interest -- and have never been proven to be good for you.
It is VERY rare for anyone to need cholesterol-lowering drugs. Among the more than 20,000 patients who have come to my clinic, only four or five of them truly needed these drugs, as they had genetic challenges that required it. If you or someone you know is taking them, odds are very high, greater than 100 to 1, that you or they don't need it.
This is true whether the drugs are statins or the newer Zetia and Vytorin.
You should know that among the many dangers of statins drugs is an increased risk of heart disease. This is because patients taking statins become depleted in Coenzyme Q10 (CoQ10), which leads to fatigue, muscle weakness, soreness and, ironically, heart failure.
The FDA has had a petition to label statin packages with a warning about statin-induced CoQ10 depletion for years, but nothing has been done about it. Some of the other risks of statin drugs include:
- Muscle aches
- An increase in cancer risk
- Immune system suppression
- Serious degenerative muscle tissue condition (rhabdomyolysis)
- Potential increase in liver enzymes so patients must be monitored for normal liver function