STATIN DRUG INFORMATION THAT MAY SAVE YOUR LIFE.

[Preciouslife1]

Vytorin's Missing Fail-Safes

http://www.forbes.com/2008/01/24/sch...25vytorin.html

Thanks DD for article..
Matthew Herper
01.25.08, 6:00 AM ET

For Merck and Schering-Plough, the pile-on over the cholesterol drug Vytorin shows no signs of letting up. The latest: Plaintiffs' lawyers are licking their chops, and Charles Grassley, the powerful Iowa senator, has begun his own inquiry into the companies' handling of a failed clinical trial.

Meanwhile, Michigan Democrats Bart Stupak and John Dingell are asking about everything from the companies' television advertising to insider stock sales to mishandling of data. They're also asking Merck and Schering-Plough some arcane questions about how the failed clinical trial, called ENHANCE, was constructed.

The answers matter to investors, top researchers say. ENHANCE lacked expert committees that might have helped the companies avoid delays in releasing the data. Those committees may also have given them a legitimate way to handle any problems that came up, averting the public relations disaster that has caused share price declines of 15% for Merck and 25% for Schering as investors worry about the future of the companies' $5 billion cholesterol franchise.

A Jan. 22 letter from the Committee on Energy and Commerce to the chief executives of Merck and Schering-Plough asks essentially the same question, eight different ways: Were there standing committees held to monitor the safety of the trial, or to deal with problems that came up in its progress?

Schering chief medical officer Robert Spiegel provided the answer in an interview with Forbes.com more than a week ago. This study had neither a steering committee, as a group of experts who regularly convened to discuss the trial and its data, nor a data safety monitoring board (DSMB), which carefully watches study information to make sure patients are not harmed.

"You would have thought they would have been more sophisticated in doing trials and would have had all the right checks and balances," says Eric Topol, chief academic officer at the Scripps Health in California. "Every real trial should have both. You need to have the weight of a committee. You can't just have one individual to stand up to the sponsors."

Spiegel said that although steering committees are helpful, that is simply not the structure chosen for this trial. And a safety board wasn't necessary, because all patients were clearly getting "adequate cholesterol therapy."

The 700 patients in the ENHANCE trial, who all had a genetic disease causing their levels of bad cholesterol to spike without treatment, were all on the top dose of the cholesterol-lowering drug Zocor. Half of them also got Zetia, a second cholesterol drug, but there was no additional benefit on artery plaque. Vytorin is a combo pill of Zetia and Zocor. There was no sign Zetia was unsafe.

The lack of a data safety monitoring board is "sub-optimal," says Steven Joffe, a bioethicist and researcher at the Dana Farber Cancer Center. "It's hard to see who is helping to shape these decisions who has a strong level of independence from the company. Who has seen the data who can take public accountability?"

A DSMB might not take direct accountability, he notes, but it provides a mechanism that can reassure the public when problems happen.

Not everyone agrees. "I do not think a DSMB for ENHANCE was necessary," says Steven Nissen, head of cardiology at the Cleveland Clinic. He does, however, think the lack of a steering committee was "irregular."

Here's the rub: Schering-Plough wound up calling an ad hoc group on Nov. 16, 2007, to try to decide how to deal with what the company says were data problems. Schering and Merck have blamed the long delay in releasing details of the ENHANCE study on problems the companies saw with the imaging data in the study.

"We did think it was appropriate, as the study was still blinded, to try and get some outside opinions to just validate that the assumptions we made when the study started," said Spiegel.

If that decision had been made by a standing group of experts instead of an ad hoc group, it would have drawn less scrutiny. The same goes for the long delay in the study--if outside experts had been named ahead of time to make decisions about the data, there would be no debate over whether Merck and Schering did the right thing with regard to this trial.

Instead, they must now face a debate in which many top cardiologists argue that their drugs should only be used as second-choice options--and a congressional committee that is questioning every step they took--with the benefit of 20/20 hindsight.


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[Preciouslife1]

Cholesterol-Lowering Drugs Will Wreck Your Muscles

Cholesterol-lowering “statin” drugs often come with side effects. The most frequently reported consequence is fatigue, and about 9 percent of patients report statin-related pain.
The results of a new study show that statins at higher doses may also affect the ability of the skeletal muscles -- which allow your body to move -- to repair and regenerate themselves.
The study examined the proliferative capacity of human satellite cells when exposed to the statin simvastatin. They found that higher end concentrations of the drug led to reduced proliferation, which would likely negatively affect the muscle's ability to heal and repair itself.

Sources:

• Eurekalert September 25, 2008

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Statins -- a class of drugs used to lower your cholesterol -- are among the most commonly prescribed medications in the world. I’ve long maintained that statins are one of the most unnecessary drugs there is, and I’m not about to change my mind anytime soon. The list of studies documenting their dangers to your health just keeps getting longer.
With at least 12 million Americans taking statins, and experts' recommendations that another 23 million “should” be taking them, it's important to educate yourself on this issue.
Now, there are a very small group of people with genetic enzyme defects that end up having cholesterol levels above 325-350. These are about the only individuals in my experience, who seem to benefit from statins. In my clinical experience, which spans over more than two decades and thousands of patients, there have been a grand total of three patients that required statins to control this genetic problem.
For the remainder of you, taking a statin drug to control your cholesterol levels will likely do far more harm than good.
The Dangerous Side Effects of Statin Drugs
Statins have been known to cause muscle pain and weakness, but no one knew exactly why. More recent studies, however, have shed light on this mystery – including the latest study above. These findings add valuable talking-points to your arsenal when discussing your need for a statin drug with your doctor.
As Dr. Thalacker-Mercer, a member of the research team, stated:

"While these are preliminary data and more research is necessary, the results indicate serious adverse effects of statins that may alter the ability of skeletal muscle to repair and regenerate due to the anti-proliferative effects of statins."

And,

“It is possible that older adults may not be able to distinguish between muscle pain related to a statin effect or an effect of aging and therefore adverse effects of statins in older adults may be under-reported.”

In this study, the viability of the proliferating cells was reduced by 50 percent at a dose *************************alent to 40 milligrams of Simvastatin – the dose per day used in some patients. This could clearly have a negative effect on your skeletal muscles’ ability to heal and repair themselves, and could lead to eventually becoming more or less incapacitated.
Additionally, a study published last year in the Journal of Clinical Investigation found that statin drugs can activate the atrogin-1 gene, which plays a key role in muscle atrophy.
Three separate tests showed that even at low concentrations, statin drugs led to atrogin-1 induced muscle damage. As the drug dose increased, the damage increased as well.
One thing is for sure. You should NOT ignore symptoms of pain and muscle weakness, as they can deteriorate into even more dangerous conditions, including death.
For example, Bayer's statin, Baycol, was pulled from the market in 2001 after 31 people died from rhabdomyolysis, a condition in which muscle tissue breaks down resulting in kidney failure.
Adding insult to injury, Vytorin, a drug that combines two cholesterol drugs -- Zetia and Zocor – into one pill, has been found to cause the opposite effect of that desired: plaques grew nearly TWICE AS FAST in patients taking the Zetia-Zocor combination compared to those taking Zocor alone.
Experts called the results “shocking.”
Other serious and potentially life threatening side effects include, but are not limited to:

• An increase in cancer risk
• Immune system suppression
• Potential increase in liver enzymes, so patients must be monitored for normal liver function

What You Must Know About Cholesterol
Statin drugs work by preventing the formation of cholesterol, and reducing LDL cholesterol, which is considered the "bad" cholesterol. There is no argument that these drugs are effective at lowering your cholesterol levels. However, they in no way, shape or form, treat the cause of your problem.
In order to understand why you don’t need them to manage your cholesterol levels, you first need to understand that there is no such thing as “good” or “bad” cholesterol.
Both HDL and LDL cholesterol perform vital functions in your body, which is why it’s actually dangerous to bring your LDL levels down too low.
HDL (high density lipoprotein) and LDL (low density lipoprotein) are actually proteins that transport the cholesterol to and from your tissues. Cholesterol in turn is a precursor to steroid hormones. (For example, you can’t make testosterone or estrogen, cortisol, DHEA or pregnenolone, or a multitude of other steroid hormones that are necessary for health, without cholesterol.)
Even more importantly, you can’t make new cell membranes without cholesterol.
So, the major reasons your body makes cholesterol in the first place, and why you have LDL, is to take the cholesterol to the tissue so you can make new cells or repair old damaged ones.
You also need to be aware that statins are non-specific inhibitors of not just one, but a number of very important liver enzymes. For example, not only do they block HMG coenzyme A reductase (a key enzyme in cholesterol synthesis), they also block Coenzyme Q10.
CoQ10 is a vital enzyme that your body needs for energy and cardiovascular health. It is widely recommended to repair heart damage, boost the function of the heart and acts as a protectant against heart attacks and valve damage. Additionally, CoQ10 has been shown to be beneficial in heart and lung cancer, as well as maintain cognitive function.
Thus, when you take statins your production of this enzyme is dramatically depleted and you do not reap the health benefits associated with it.