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Gene Patents, Physician Mistakes, and Other Mishaps Shaping Personalized Medicine Outcomes

For years now, providers and payers have enthusiastically heralded the advent of personalized medicine. Treatments and cures genetically matched to the patient promised unprecedented prevention and cure rates, and a much needed means to thwart the onslaught of antibiotic resistant diseases. That promise still shines brightly as there is yet any empirical evidence to the contrary that would dull its sheen.

However, personalized medicine is running headlong into some unexpected and serious obstacles.

For one thing, too many physicians have yet to understand it fully and therefore they are making mistakes in administering the new personalized drugs. ModernHealthcare.com reports that in the practice of oncology in the U.S., physicians are commonly prescribing personalized medicines without doing the required genetic testing first, or they are using substandard diagnostic tests.

“Laboratories in some cases have created their own versions of companion diagnostic tests, which have never been approved by the FDA,” writes Jaimy Lee, the author of the ModernHeathcare.com report. “It may be leading to less-than-accurate results, but physicians may order tests from labs that promise lower costs or more convenience for the provider.”

However, physicians may also be required by some insurance providers to use only certain labs which could lead to restricting the doctor’s choices to the tests those labs make available.

Such practices can lead to a potentially false read on the effectiveness of personalized medicine. Certainly such doesn’t help the patient any. But bottom line, insurers may hesitate to cover personalized medicine believing it either ineffectual or prone to misuse if these practices are not corrected soon. It doesn’t help that the costs are exorbitant too.

A 2012 UnitedHealth Group report found that the U.S. is spending over $5 billion on genetic testing and those costs may increase to $25 billion by 2021.

“What new technology is supposed to do is lower the cost of care, not just keep it equal,” says Dr. Lee Newcomer, UnitedHealthcare's senior vice president of oncology, genetics and women's health in the March 2013 ModernHealthcare.com article. “We spend more money on that than we do on chemotherapy medicines. It is an expensive field. What we have to do there is learn to be just as responsible by using the right test in the right situation and they can't be priced so exorbitantly.”

Gene patents have a role in those exorbitant costs as well as a role in blocking improved diagnostic tests from ever coming to market.

A recent PBS NOVA report titled “Are Gene Patents Standing in the Way of Personalized Medicine” details how it came to be that scientists raced to patent their gene discoveries, some missing publication and patent scores by mere minutes, in an effort to keep federal funding for more research. But now those very same patents have led to oodles of lawsuits.

“Initially, the uproar focused on private companies using findings from dozens of federally funded researchers to gain exclusive rights over a gene, writes Amy Maxmen in the NOVA report. “Now researchers and clinicians worry that gene patents compromise their ability to tailor treatments to individuals based on their DNA.”

“But recently, some researchers have hesitated to bring new and improved tests to the clinic for fear of infringing on a patented gene,” she continued in that same article. “It’s gotten to the point that Francis Collins, director of the National Institutes of Health, calls gene patents ‘an impediment to personalized medicine.’”

Clearly these and other related issues will need to be addressed quickly in every country in order for mankind to truly benefit from personalized medicine. It starts with education for the providers, the patients, and the legal system so that each can recognize what must be done.

And on that note, I’ll leave you with a fun video of Francis Collins, director of the National Institutes of Health, singing a very educational song about personalized medicine at the annual Public Interest Organization meeting at the National Institutes of Health's National Heart, Lung, and Blood Institute in 2010.

There’s been no word as to whether he still feels like singing it after his comments on the gene patent fray.

Gene Patents, Physician Mistakes, and Other Mishaps Shaping Personalized Medicine Outcomes

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