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It's Time For A National Institute of People's Medicine.

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Pharmaceutical corporations are failing seriously. No, I don't mean financially. Each of big pharma's top five have annual revenues topping forty billion dollars. Instead the drug industry is floundering in its ability to provide the public with many of the basic medicines that are absolutely required for the treatment of a host of diseases.

First, there is an ongoing critical shortage of specific well-established medicines. The tragic result is that some patients may not receive life-saving, life-extending, or palliative therapies. This dearth of medications includes vinblastine and vincristine, two chemicals found in Madagascar's Rosy Periwinkle. These two drugs revolutionized the therapy of childhood leukemia, changing the prognosis from almost certain death to nearly certain cure. Also increasingly scarce is Taxol  (Paclitaxel), a gift from the Pacific Yew Tree and discovered through research financed by the National Cancer Institute. Since it's launch in 1992, Taxol has been an essential component in the chemotherapy of breast and ovarian cancers as well as AIDS-associated Kaposi's sarcoma. The global giant Bristol-Myers-Squibb generated well over ten billion dollars in revenues from this taxpayer-financed discovery.   Another shortfall involves the cancer chemotherapy mainstay Cytarabine, employed in the therapy of leukemia and lymphoma. There is also a sparsity of the drug thyrogen, used in protocols to test for or treat thyroid cancer. Presently there are at least 14 generic cancer drugs in short supply. And the shortages don't stop there.

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The U.S. Food and Drug Administration reports that the number of drug supply shortages nationally nearly tripled during the last six years. Medicines with supply insufficiencies numbered 61 in 2005, but that count leapt to 178 in 2010.   Not only cancer treatment drugs, but also anesthetics, antimicrobials, and pain medications are included in those startling numbers.

What is the cause of perhaps the worst drug supply crisis in thirty years? There are many factors at play including raw materials supplies, production and inventory issues, and the way Medicare sets drug prices. But an overarching influence is the pharmaceutical industry's profit motive:   multibillion-dollar revenues don't come from producing generic standby medicines.

The other pharmaceuticals crisis is looming larger and even more frightening. The Center For Disease Control reports that greater than 70% of hospital bacterial infections are resistant to one or more classes of antibiotics. The direct results are 90,000 deaths per year in the United States and 4.5 billion dollars in extra healthcare costs.

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As a society, we have forgotten what life was like without antibiotics. Antibiotics have increased the span and quality of human life, and decreased post-surgery complications.

The so-called "drug pipeline" is drying up in its capacity to provide new antibiotics. FDA commissioner Dr. Margaret A. Hamburg calls the number of antibiotics in development "distressingly low." Why bother to discover or develop a drug that can cure in a few days?   The profits lie in "lifestyle drugs," like those for high cholesterol, diabetes or depression. The patient most probably will have to buy these drugs for the remainder of her life. Put a lifestyle drug together with a huge patient population and you have the industry's motherlode known as he "blockbuster drug."

In matters of public health, if we can no longer depend on the profit-driven drug industry, the government must step in. Proposals to encourage needed pharmaceutical company action with patent extensions and tax breaks miss the mark.   Rather we must establish a rock-solid platform for drug supplies and for antibiotics R & D. The eight hundred pound canary that no one wants to put forward in these strange days on planet Earth is the creation of a National Institute of Peoples' Medicine (NIPM). This new entity would join the other 27 institutes and centers at the National Institutes of Health (NIH). The NIPM would be a sleek, trim administrative agency that would ensure that drug inventories are always well stocked. It would additionally be the driver and funder of cutting-edge drug discovery and development for antibiotics.   Working through out-sourcing and contract mechanisms, the NIPM could rejuvenate research funds-deprived academics and mobilize small pharma to manufacture requisite medicines.  

Appropriate established models for this venture already exist. For instance, the National Institute of Allergy and Infectious Diseases has a branch that awards competitive contracts for research on biodefense, HIV/AIDS, tuberculosis, and other infectious diseases. A separate institute for drug supplies and antibiotics R & D would ensure a visible budgetary focus on those issues.

The benefits accruing to the to the public could be substantial, aside from a dependable supply of valuable drugs and new antibiotics. There would be no need to generate stockholder gains and executive super-salaries. Gone also would be the immense expenditures for advertising and marketing. The NIPM and FDA would be the source of facts about these medicines, not glossy brochures and advertisements generated by a profit-motivated industry. Overall, drug misuse and overuse would decrease with concomitant savings to the consumer.   Jobs in this vital enterprise could be created here in the U.S., rather than being shipped overseas as foreign outsourcing continues to increase in the pharmaceutical industry.

Are we taxpayers to foot the bills for the very best biomedical research establishment in the world, and then be held hostage by those who have benefited financially from our generosity?  Can we stand by while government attempts to apply one band-aid, then another, as our access to essential medicines becomes more remote?   Not all revolutions in human health need to be of scientific origin. A National Institute of Peoples' Medicine could fill a widening gap in our healthcare system and ensure that no one is denied a medicine simply because it isn't a "blockbuster."

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Paul F. Torrence is Emeritus Professor of Chemistry and Biochemistry at Northern Arizona University, Flagstaff, USA. His career spanned 30 years at the US National Institutes of Health where he was a Section Chief and then 8 years at Northern (more...)
 

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