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Biotech
Personalized medicine could be antidote to soaring care costs
Daniel S. Levine
Here's a little secret of the pharmaceutical industry: Lots of the drugs they sell don't work on a large portion of the people who use them.


All right, so it's not so little and it's not so secret.

Antidepressants fail in 20 percent to 50 percent of patients who use them.

Got my mojo working.

Cholesterol-reducing statins fail in 30 percent to 70 percent of patients who use them.

Got my mojo working.

And beta2 agonist drugs fail in 40 percent to 70 percent of all patients who use them.

Got my mojo working, but it just won't work on you.

Treating patients with drugs that don't work is not only bad medicine, it is a waste of money in a health-care system struggling to rein in costs. Some see personalized medicine as the answer to this problem.

Through the unraveling of the human genome and the pairing of diagnostics and therapeutics, doctors are gaining the ability to genetically determine whether a given drug will work on a particular patient. Genentech's breast cancer drug Herceptin is the classic example of this. Before a patient is given the drug, a test is used to see if the patient overexpresses the HER2 gene. About one in four breast-cancer patients overexpress the HER2 gene and for them the drug is effective.


The Washington, D.C.-based Personalized Medicine Coalition, a year-old education and public policy advocacy group, wants to make sure this so-called age of personalized medicine arrives. Ed Abrahams, executive director of the coalition who was in the Bay Area for a dinner meant to draw new members to the group, said it's not the scientific, but the political, regulatory and economic barriers that need to be overcome for personalized medicine to succeed.


"We're asking the questions that need to be answered," Abrahams said. "We don't necessarily have the answers. We are setting the table where interested parties can come and work out those answers."

First, there is the political reality that two-thirds of Americans fear that their genetic information can be used against them by insurance providers and employers. There is legislation in Congress that would prohibit genetic discrimination, and Abrahams said it is important to pass such protections.

"You want to take that off the table and say it's not going to be an issue," he said.

In the regulatory arena, the question is whether regulators will provide incentives for drug developers to link diagnostics and therapeutics. Developing a test that eliminates the 50 percent of patients that won't benefit from a drug also promises to eliminate 50 percent of its sales. Will drug makers get extended patent protection for developing drugs that are safer and more effective?

No less significant is the question of how payers will reimburse people for personalized medicine. Though Centers for Medicare & Medicaid Services Administrator Mark McClellan is seen as supportive of personalized medicine, the industry may face a tough sell to justify higher prices for drugs that are paired with diagnostics, even though they promise to deliver overall economic benefits in the long run.

Raju Kucherlapati, a professor of genetics at Harvard University, who was scheduled to speak at the dinner, said he plans to launch a clinical trial involving patients with multiple diseases to establish that personalized medicine delivers better care at lower costs. The hope is the trial will demonstrate that patients treated with consideration of their genetics get better care for less cost than those treated with the current standard of care.

It's easy to consider the wonders of personalized medicine and how it will improve health care for not only patients and doctors, but payers, too. But there are also ethical questions personalized medicine will likely raise that may not be front and center in the discussion.

What will happen when a doctor has a patient where a diagnostic indicates the drug for his disease will not work for him and it is the only drug available? Will the patient insist on getting a useless drug? Will the doctor prescribe it assuming that even though it probably wouldn't work, it's better than nothing? Will a payer refuse to cover the cost of the drug if a diagnostic test says the drug is not right for the patient and will it be right to do so? These questions will need to be addressed, too.

Daniel S. Levine can be reached at [phone] or [e-mail].


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