Fresh off recent news that more than 1,000 people have filed lawsuits for damages due to cholesterol-lowering drugs since April this year (2014), comes the remarkable story reported in the Wall Street Journal that Regeneron Pharmaceuticals, Inc. and Sanofi SA are spending $67.5 million to purchase a voucher that will allow them to get the FDA to fast-track approval of a new class of cholesterol drugs. By purchasing this voucher, they hope to beat rival drug company Amgen, Inc. in being the first to market with these new cholesterol-lowering drugs.
Bloomberg Businessweek is reporting that this is a first-of-its-kind deal offered by the FDA to fast track a drug through the purchase of a voucher. However, the original voucher issued by the FDA was not even for a cholesterol lowering drug. It was originally issued to BioMarin Pharmaceutical under a 2012 law designed to reward companies for investing in drugs for rare childhood diseases. This law, which the FDA says was “intended to encourage the development of treatments for rare pediatric diseases,” also allowed those awarded such vouchers to sell them to other drug companies for the development of other drugs.
This has effectively created a type of legal “black market” where drug companies can sell these vouchers to the highest bidder, even though they were intended by the FDA to approve new drugs specifically for the “development of treatments for rare pediatric diseases.” Since this apparently does not raise any ethical questions in the mainstream media, I will raise them here:
1. Why did the FDA issue these vouchers in the first place? If it wanted to encourage companies to develop treatments for “rare pediatric diseases” why not just give them preferential treatment based on the merit of their products without issuing “vouchers”?
2. Who benefits from the issuance and sale of these vouchers? BioMarin made $67.5 million by selling the voucher the FDA gave them to develop pediatric drugs for “rare diseases.” It would seem the sole purpose of the vouchers is to create a market for drug companies to prosper, with no clear benefit to the consumer.
3. What does this say about the cholesterol drug market, given what we already know about it? Lipitor, the blockbuster cholesterol-lowering statin drug, earned Pfizer over $140 billion (that’s BILLION with a “B”) during its patent run, more than any other drug in the history of the world. The FDA also earns much of its revenue from fees paid by drug companies. They did not issue warnings about statin drugs until 2012, just a couple of months after Pfizer’s patent on Lipitor ran out. Today, thousands are filing lawsuits against Lipitor and other statin drugs for damages due to the drug use, such as diabetes. Current cholesterol-lowering drugs are also linked to increased breast cancer, neurodegenerative diseases like Alzheimer’s, and others. Do you feel that a new fast-tracked cholesterol drug will be safe??
The whole lipid theory of heart disease is without merit, and is quickly falling apart based on actual data. For example, the science shows that low cholesterol levels, not high, are linked to higher mortality rates. Even the main claim made by cholesterol-lowering drugs, that it reduces one’s risk for cardiovascular disease, is questionable based on the data. The fact that it does not prolong one’s life, and that they have serious side effects, is no longer even challenged.
Some doctors (mostly in Europe) are finally beginning to wake up and understand how dangerous these cholesterol lowering drugs are with no real benefit, but don’t expect the medical system in the United States to admit this anytime soon. It would result in the loss of billions of dollars in revenue, and even more lawsuits than are currently piling up. One of out every four Americans over the age of 50 is currently taking cholesterol-lowering drugs, so this is not a market they will give up easily. Consumers refusing to take the drugs are the only thing that will change the current market.
Only YOU the consumer can stem the tide, by doing your own research and saying NO to cholesterol-lowering drugs, even if it means going against the advice of your doctor.
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