Update On Merck

September 16, 2008

Gardasil, A Vaccine Being Forced On Young Girls, Is Dangerous As Well As Unproven
Merck’s Gardasil vaccine is supposed to prevent young women from getting cervical cancer. Now the FDA has approved a claim for two less common cancers as well.

Gardasil really prevents some (but not all) of the genital warts that may lead to cervical and other cancers. This leads to the supposition that it will also prevent cancer. Whether it will actually prevent cancer is unknown.
Partly because three painful and expensive ($375) shots are required, Merck’s marketing plan has been to persuade state legislators to make the shot mandatory. Company money has flowed to governors and legislatures to make this happen.
As of July, the federal government’s Vaccine Adverse Events Reporting System has received over 9,700 reports of problems since the vaccine’s introduction in 2006. These include paralysis, seizures, and miscarriage. Twenty deaths have been reported although the government has not acknowledged a link yet.
Vaccines were originally developed to protect the public from extremely contagious diseases spread primarily by air. Now we have dangerous and unproven vaccines mandated in the hope they will guard against diseases that require sex or very intimate contact to transmit. The pioneers of the public health vaccine program would be appalled.
We need to fight Merck’s efforts to make its vaccine mandatory in every state. Write your governor and state legislator to tell them you oppose the Gardasil vaccine.
Merck’s Grab for the B Vitamins
As we mentioned two weeks ago, natural substances aren’t supposed to be patentable. That’s why most drugs are made from unnatural, patentable molecules that are unfamiliar to our bodies. Because these molecules are new, they tend on average to be more dangerous and have more side effects.
Although natural substances aren’t supposed to be patentable, Merck has gotten a use patent on what many consider the best natural form of the key B vitamin folate, 5-methyl tetrahydrofolate (sold as Metafolin). The same reader who pointed out last week that synthetic B-6 will still be available if Medicure Pharma gets its way about banning the natural, bio-active form of B-6 also asked: why do we need natural folate? If that is no longer available, we will still be able to buy folic acid, a synthetic form of folate.
But synthetic folic acid may be dangerous in ways that natural folate doesn’t appear to be. One theory holds that both folic acid and folate are cancer protective. But once cancer gets started, high doses of folic acid (unlike folate) may lead to more cancer growth. A study of 25,000 postmenopausal women showed no breast cancer risk from natural folate, but a 32% increased risk with high folic acid supplementation (Am J Clin Nutr, 2006;83: 895-904).
Merck’s Cordaptive (a `version` of vitamin B-3) Turned Down
The FDA did the right thing on this one. Vitamin B-3 in the form of niacin has long been known to raise HDL cholesterol (so-called good cholesterol) and provide other protections against heart disease. Merck thought that it would produce its own patentable `version` of niacin by adding a bit of another drug (laropiprant), give it the name Cordaptive, and get FDA approval. Once FDA approval is granted, the new drug can then be prescribed freely by doctors and reimbursed by Medicare and Medicaid. The fact that an approved vitamin knock off will cost vastly more and involve unknown dangers doesn’t enter into the equation. The FDA didn’t say why it turned this drug down.

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