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Forced to abide by the onerous rules of the FDA, a drug company knows it can squeeze only one or two drugs through the regulatory barrier each year. The company, therefore, tends to focus its research priorities on drugs that can be used to treat millions of patients, rather than risk investing in more speculative drugs that may be prescribed for only thousands of people. In this way, the FDA regulations nudge drug development in certain directions and tend to slow down the research on diseases that may be serious but also rather uncommon.
Research and development spending certainly hasn’t stopped. “The biopharmaceutical research sector invested an estimate $65.3 billion to discover and develop new medicines in 2009 alone,” said David Wheadon Feb. 21. He is senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA). “We’ve made dramatic strides in the battles against diseases…Today nearly 3,000 medicines…are in development. Our companies create the vast majority of new medicines from start to finish…in collaboration with academia and NIH.”
A recent example of government-controlled medicine was reported Feb. 18 by American Thinker, as well as many other publications. It was the FDA’s ruling to ban doctors from prescribing Avastin, the drug for patients with breast cancer. Avastin is an expensive but powerful drug for those with advanced stages of breast cancer.
FDA’s reasoning: Avastin does not provide a “sufficient benefit in slowing disease progression to outweigh the significant risk to patients…” Why shouldn’t a mother, or wife, or daughter be allowed to spend her money to gain an extra month or year, or even a week? As long as patients are willing to take the risk and able to pay the high price, why should FDA dictate the course of action?
Health care issues typically considered most important by the government–costs and broad coverage–should be considered as secondary to innovation. Medical treatment must first be invented, the Cato Institute said in a recent study.
An article last year in the Journal of Clinical Oncology said that increased regulatory delays in drug approvals result in the loss of nearly 300,000 life-years in the United States. The authors of the study said, “The current regulatory situation is unacceptable and seems to be unethical.”
As for the NIH and its glorious plans for the new drug invention center, one biochemist, Dr. Mark Lively, a Wake Forest University biochemist, was quoted in The New York Times as saying: “The NIH is not very good at drug discovery, so why are they doing this?”
Why indeed? Do we need another government body in an already untrustworthy drug discovery and approval process?
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