Somebody needs to smack the head of the FDA : How is Gardasil safe for minors but not Plan B?

This is unbelievable.

Andrew von Eschenbach, the Acting Commissioner of the FDA, claims Plan B is supposedly not safe for 16 year-olds (the age Barr was seeking as their lowest threshold for unsupervised use) but it is OK for 18 year old.

[via Letter to Joseph A. Carrado, M.Sc., R.Ph., July 31, 2006]:

We are now proceeding with further evaluation of your sNDA. We would like to meet with you as soon as practicable, and preferably within seven days, to discuss the status of your sNDA, including any necessary amendments. For example, your sNDA seeks approval for OTC use for women ages 16 and older. As we informed you in our August 26, 2005 letter, the Center for Drug Evaluation and Research concluded the available scientific data are insufficient to support the safe use of Plan B as an OTC product for everyone in that age group. Moreover, because of enforcement considerations, we believe that the appropriate age for OTC access is 18. Should you desire to proceed with your sNDA, you would need to amend it to seek approval for OTC status for women ages 18 and older. In addition, you would need to amend your sNDA with respect to packaging.

Is it scientifically possible for the body of an underage woman to change so dramatically in two years?

But the FDA doesn't stop at bogus scientific claims. It goes into the marketing and selling of the product : Barr Laboratories can only sell Plan B to pharmacies that will be willing to card buyers AND keep it behind the pharmacists' counter.

We would also like to discuss the details of the CARESM Program that you submitted with your sNDA. That program regards your proposed marketing, education, distribution, and monitoring for the OTC version of Plan B�. Specifically, we would like to learn more about your proposal to restrict distribution of Plan B to certain pharmacies, i.e., the OTC version of Plan B would not be available at gas stations, convenience stores, etc., but only to those pharmacies agreeing to (1) keep the OTC version of the drug behind the pharmacy counter and (2) dispense the drug only upon the production of a valid photo identification card establishing the age of the consumer. In particular, we would like to learn more about your plan to routinely monitor these pharmacies to make sure they comply with the restricted distribution plan. In addition, we are very interested in learning how you plan on enforcing the restrictions if a pharmacy fails to comply with them, e.g., whether the restrictions will be incorporated into the terms of a formal contract and, if so, what the terms of that contract (particularly those terms related to a breach) look like.

Earlier this summer there was quite a stir over the approval or Merck's Gardasil vaccine in all pre-adolescent girls. Since the link betweenn genital warts and cervical cancer was found, there's been an aggressive campaign to force parents into immunizing their underage daughters.

Isn't there something horribly wrong when the FDA seeks to push a vaccine on little girls for a disease that can only be transmitted sexually but will not allow the same girls to have access to emergency contraception? It seems too easy to say that the FDA promoting the sexual abuse and impregnation of little girls by the choice of drugs they approve; but something even more sinister is involved in these decisions.

PlanB has been widely available since 1999 but for longer than that doctors had been experimenting with 'morning after' cocktails of contraceptives for averting unplanned pregnancies. Due to the nature of its preventive use (and the fact it's a derivative of oral contraceptives), it's potential adverse reactions have been proven to be negligible. The effectiveness and safety of this kind of drug treatment has been proven for over 10 years.

Not so with Gardasil.

The National Vaccine Information Center has every reason to believe the clinical trials were rushed to ensure approval of the drug. Merck's clinical trials did not prove Gardasil's long-term safety in children :

"Merck and the FDA do not reveal in public documents exactly how many 9 to 15 year old girls were in the clinical trials, how many of them received hepatitis B vaccine and Gardasil simultaneously, and how many of them had serious adverse events after being injected with Gardasil or the aluminum placebo. For example, if there were less than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis."

According to the Merck product manufacturer insert, there was 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis, and 1 case of reactive arthritis out of 11,813 Gardasil recipients plus 1 case of lupus and 2 cases of arthritis out of 9,701 participants primarily receiving an aluminum containing placebo. Clinical trial investigators dismissed most of the 102 Gardasil and placebo associated serious adverse events, including 17 deaths, that occurred in the clinical trials as unrelated.

"There is too little long term safety and efficacy data, especially in young girls, and too little labeling information on contraindications for the CDC to recommend Gardasil for universal use, which is a signal for states to mandate it," said Fisher. "Nobody at Merck, the CDC or FDA know if the injection of Gardasil into all pre-teen girls - especially simultaneously with hepatitis B vaccine - will make some of them more likely to develop arthritis or other inflammatory autoimmune and brain disorders as teenagers and adults. With cervical cancer causing about one percent of all cancer deaths in American women due to routine pap screening, it was inappropriate for the FDA to fast track Gardasil. It is way too early to direct all young girls to get three doses of a vaccine that has not been proven safe or effective in their age group."

What is even more terrifying about this rush to vaccination cheerleading is the thought that a whole generation of little girls is being force to act as guinea pigs for a pharmaceutical that had no economic incentive to ensure the long-term safety of its product. The FDA changed its approval guidelines in the 1990's so that companies paid for the privilege of approval. And with this new "pay-per-approval" scheme, faster and more 'streamlined' methods have been instituted for getting drugs to market with the minimum of testing needed to prove the minimum of safety required for distribution.

The problem is, recalls of deadly drugs have gone up since the pay-per-approval scheme was instituted. The Journal of the American Medical Association has blasted 'post-marketing" surveillance of drugs as potentially dangerous; as in the Vioxx cases. One could say this new twist on drug safety monitoring is in itself a clinic trial that, instead of being burdened by the pharmaceutical company, it is being imposed on users or, to use the pychopathic economic term, "the market".

Actually, that is what a scientist told me about the new wave in R&D during my years at Colgate-Palmolive. My job there was to write the reference manual or "the bible" used by all the consumer affairs representatives. My job was to get all the information that was not considered a trade secret by the company (as in their toothpaste's formula) and turn that into easily scannable information the reps could pop-up on their computer screens during a 'consumer contact' or communication.

Well ... I went a bit beyond the call of duty. I am horrendously curious about a lot of things, like the need for fluoride in toothpaste to avert cavities (not really needed), and the efficacy of tartar-control and whitening toothpastes (they don't whiten teeth at all).

So when I asked about the long terms of triclosan, the drug used on almost all anti-bacterial cosmeceuticals, including toothpaste; the guy looked at me and said : "We don't need to know".

"What do you mean you don't need to know?"

He told me that the company was not asked to provide data on what the long-term effects could be. They were only asked to fulfill the minimum amount of testing required by the FDA for approval. That was the law, as so they complied. I remember asking the guy : "So, if it has any long-term effects on the natural bacterial flora of human skin or mouth, it's none of your business". To which he gave me an uncomfortable nod. I was ferklempt. I couldn't believe the potential long-term consequences on the immune system were not being studied. I asked him, "Don't you want to know". And to my astonishment he answered : "I shouldn't, for liability reasons".

This was sometime between 1994-6. There's now evidence that indeed, autoimmunity problems may well be attributed, in part, to anti-septic (and anti-bacterial) lifestyles.

Six-years later, my gut instinct was proven right.

My past years as a consumer advocate taught me about the great lenghts pharmaceuticals will go to bend the truth to their economic favor and how the government, cash in hand, is a willing ennabler. I learned not to trust the FDA nor any of their allegedly scientific monitoring of food and drugs. For the most part, they don't work with the interests of regular people like you and me in mind. They think of "the market" and "consumers". Not people but an impersonal herd.

Injury and death from physician-monitored prescription drug use is expected. The death or neurological damage of children from a vaccine is expected as normal.

Until someone decided to wage a class-action suit ... or one too many "market samples" die.

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