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Friday, April 22, 2016

Good News For Consumers From Global Drug Manufacturers

U.S. residents pay too much for their prescription drugs and medical supplies, which reflects on our cost-plus reimbursement practice which is fueled through insurance reimbursement, whether government or private sector. This article reviews some pharmaceutical companies which are offering greater transparency and value for their products.
Transparency from a Drug Manufacturer
AstraZeneca, PLC, a UK pharmaceutical company recently published the results of its study on the blood thinner, Brillanta, which was used to prevent secondary heart attacks for stroke patients, and declared it performed no better than aspirin. [1] Stop the presses, this may not be a first, but it is unusual for a drug company to declare that its product is not effective, but then again this is in Europe where drug manufacturers can’t market their products directly to consumers and governments contract with pharmaceutical providers directly. This level of transparency should be encouraged in the U.S. where clinical study results are often buffered to enhance the perception of the drug intervention, as opposed to stating statistical significance in the absolute. By that I mean, how many people would have to be treated with the drug to show a statistically reliable difference and what would that difference mean to a realistic population of potential users? Dr. Norman Hadler of the University of North Carolina has written extensively about the misinformation that is published about clinical studies and subsequent practices which do not improve health.[2]
Generic Drug Manufacturers Are Investigating Small Market Diseases for Drug Development
When the patents expire on pharmaceuticals, any approved drug manufacturer can start to develop its off-label version of the medicine. The three largest manufacturing centers for generic medications are in India, Israel, and the United Kingdom. Indian companies have applied to the U.S. Food and Drug Administration for pharmaceutical product licensing at an increasing rate. Sun Pharmaceuticals in India, has FDA approval for a treatment of the rare blood disease, myelo-dysplastic syndrome. Another Indian drug company, Dr.  Reddy’s Laboratories (yes, this is the real name) has FDA approval for a skin spray for plaque psoriasis (a skin disease) and it is working on an improved injection for treatment of migraines.[3] Indian pharmaceuticals companies have increased their research and development budgets for new drug treatments for diseases which are being ignored by the U.S. pharmaceutical industry.By working with existing compounds from expired patents scientists can save time when developing some of the new treatments. Indian companies are devoting 17% of their budgets to research and development which exceeds what the large U.S. pharmaceutical companies spend, typically less than 10%. Because of the direct to consumer marketing and other financial incentives, the drug companies spend much more of their annual budgets on marketing, than on research. Most new research is done at universities in the U.S. and is funded through grants by the U.S. National Institutes of Health.  India does not have a government agency, like the National Institutes of Health to invest in medical research, but it does partner with the NIH on some projects.
Moon Shot for Treatment of Melanoma
More than a third of patients with advanced melanoma (skin cancer) survived five years with a new molecular drug treatment which makes T cells target the cancer. The study by Bristol-Meyers Squibb, followed 107 people with advanced melanoma to determine the effects of Opdivo.The drug has the potential to double the number of  five-year survivors for people with advanced melanoma. The U.S. Food and Drug Industry approved the drug for treatment of melanoma in 2014. Study results were presented at the American Association for Cancer Research Annual Meeting.[4]

And this is the healthpolicymaven signing off with useful information for healthcare consumers. The healthpolicymaven is a trademark of Roberta E. Winter and Praevalere Inc. Feel free to share this article virally. Roberta Winter is the author of Unraveling U.S. Healthcare-A Personal Guide, Rowman & Littlefield, 2013.

[1] Denise Roland, AstraZeneca Says Its Blood Thinner Is No Better Than Aspirin, Wall Street Journal, March 24, 2016
[2] Norton M. Hadler, The Citizen Patient, University of North Carolina Press, 2013
[3] Suryatapa Bhattacharya, Indian Drug Makers Target Niche Markets, Wall Street Journal, April 19, 2016
[4] Drug Seems to Extend Survival for Advanced Melanoma, Medline Plus, U.S. National Library of Medicine, April 18, 2016

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