The Obama administration will try to correct the FDA's imposition on the drug market with more government.
When pharmaceutical companies search for a new drug, failure is normal, even after years of risky, expensive experimentation. So, sound the trumpets: Uncle Sam to the rescue with a new research center to help produce medicines! Why not? The Obama administration got in the automobile business, banking, even home weatherizing. Why not the drug industry?
Sadly, the plan to create a new National Center for Advancing Translational Sciences (NCATS) is a “near perfect example of how government failure (in the inaction of the Food and Drug Administration) leads to further government interference with markets.” In this case, “the market for new medicines,” said Reason.com in a Jan. 25 story.
After a rising level of research for many years, the number of new drugs to go on the market has slipped over the past 15 years. A major reason is the Federal Food and Drug Administration (FDA) bureaucracy and its belabored approval process. More recently, the recession and fears that ObamaCare mandates could bring drug price controls, influenced drug companies’ cut back in research spending. But those are not excuses in President Obama’s impatient view.
“Since many companies do not invest in basic research that does not have an immediate pay-off,” said Obama in his budget message, “we—as a Nation—must devote our resources to these fundamental areas of scientific inquiry.” He specifically mentioned biomedicine.
Dr. Francis Collins, head of the National Institutes of Health, criticized what he saw as declining drug industry research in a New York Times article in December. He said, “It certainly doesn’t show any signs of turning upward.” Collins seized the reins of the new drug center, with plans to open it as soon as this coming October. Collins also told The Times, “None of this is intended to be competitive with the private sector,” Oh, yeah? The center was reported by Merolic.com to invest a billion in basic research.
Collins, for many years, headed the Human Genome Project at NIH. Tens of billions of dollars were invested in it by the drug industry. Scientists believed they would find cures for cancer, HIV, and other diseases that plague humanity. But the industry looked askance at the promises and finally decided not to invest more money because there had been so many failures. A frustrated Collins decided to get the government involved, Metrolic.com reported.
The New York Times story said the NCATS “might need to discover not only the right chemicals but also to perform animal tests...and even start human trials to see whether they work. All of that has traditionally been done by drug companies, not the government.” Collins has indicated he is willing to “cannibalize” other parts of the NIH to bring more resources to the center.
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?