A Major Reversal:
No Patents on Genes
Gene patents have been issued for decades. The Patent and Trademark Office has granted thousands of patents on genes from various organisms, including about 20 percent of human genes. This has enabled the biotechnology industry to drive remarkable advances in medicine.
In late October, the Department of Justice declared that human and other genes should not be eligible for patents because they are part of nature.
The road to reversal began when a lawsuit was filed challenging patents covering the BRCA1 and BRCA2 genes and patent-holder Myriad Genetics' screenings that determine predisposition to breast and ovarian cancers. A district court judge in Manhattan ruled the patents invalid because genes carry important information, whether in the body or isolated from it, that can't be patented. His ruling prompted the government to reconsider its policy.
A subsequent friend-of-the-court brief stated: "The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth."
Such a reversal and adamant position could endanger the progress being made in diagnostic testing and in development of highly effective new drugs designed to work in conjunction with the patient's genetic makeup.
I often write about how this progress is already helping patients. BRCA2 screening provided early diagnosis to a cancer victim's children so they could avoid chemotherapy and invasive treatment. In clinical trials, patient-tailored cancer vaccines have brought remission in difficult cases. Extracted genes, and the potential they hold for improving people's lives, are not at all like the limited possibilities of extracted cotton fibers and coal.
The government's stand on patenting genes is not merely a matter of principle. It's a matter of life and death for current and future patients who depend upon the medical advances made possible through the development and delivery of gene therapies.
Appeals to the government's new stance are in progress. Let's hope they lead to a second reversal and further steps forward for biomedical science and the patients who benefit from it.
— Tom DeSanto
Trying a New Answer to Cancer Costs
The Problem
• Spending on cancer treatment is rising 15 to 18 percent annually, nearly double the rate of general health care costs.
• Drugs account for an estimated 65 percent of an oncologist's income.
• Customarily, doctors purchase cancer drugs, infuse them in their offices and then bill insurers for their cost plus a 15 percent profit margin.
How can cancer costs be reduced while ensuring that patients receive proper treatment and doctors are compensated fairly?
Their Answer is being tested in five cancer clinics for breast, colon and lung cancer. It works like this:
• Doctors decide in advance which drugs they would like to use in the patient's treatment plan, from generic chemotherapeutic agents to more costly branded drugs.
• UnitedHealth pays the doctors for whatever choice they make, but without the customary markup. Instead, the doctors receive a set fee that includes the profit they would have made, plus costs for managing patient care.
• If the doctors use a drug not in the treatment plan, United Health Group covers the cost of the drug, but will not increase the separate payment covering markup and patient management.
• In addition, treatment data would be shared among participating clinics to identify the most effective methods.
Reaction
Some groups argue that the plan could provide an incentive for doctors to withhold treatment from patients, especially if the separate payment doesn't cover enough costs.
I believe separating the ability to earn additional profit from prescribing more expensive drugs is a step in the right direction. We need to trust physicians to decide which drugs they prefer to use, cover the cost of those drugs and to provide them with collective data to support future decisions — without rewarding more expensive treatment options.
The outcome from the test program remains to be seen. In the meantime, UnitedHealth Group is to be applauded for seeking answers that respect physicians' judgment and support their financial success.
— Tom DeSanto
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