- The Washington Times - Monday, December 6, 2004

Most people will think of 2004 as a yet another year when the drug industry was on the defensive: A spate of critical books; a presidential candidate who made drug imports from Canada a mainstay of his campaign; the withdrawal of a widely used painkiller. And if we needed to be reminded about why we care so much about medicines — or why drugs are a great political issue — a government report shows that 44 percent of all Americans use medicines, an increase of about 5 percent from a few years ago.

The reasons people take drugs to the extent they do has less to with marketing than with the scientific transformation of medicine from palliative practices that merely keep people comfortable to a predictive and personalized pathway to providing people with treatments that reflect their particular genetic response to disease and drugs.

Indeed, the Vioxx story says less about the real role of medicines in our lives than the story of 71-year-old Doug Jensen, who back in 1997 was diagnosed with chronic myelogenous leukemia (CML). Back then, the only treatment available was bone marrow transplants or Interferon, a drug with side effects that were much more devastating than the disease itself. Mr. Jensen’s doctors took him off Interferon to allow him to die in peace. At the same time Mr. Jensen found out about a clinical trial for a new cancer drug called Gleevec, which, unlike any other cancer drug before, was developed based on the understanding of what drives the growth of cancer and precisely targeting the cancer mechanism without any side effects.

Now Gleevec treats many cancers that use the same mechanisms and many other cancer drugs are being developed that not only target specific cancer genes, but also work for specific groups of patients, such as children or women with a particular genetic profile. As for Mr. Jensen: “As far as I’m concerned, it’s a miracle,” he said. “I look back now from when I was first diagnosed — I’ve gotten two new daughters-in-law, new grandkids. My wife and I just had our 48th wedding anniversary. Those are all things that I’d never have had, if it hadn’t been for Gleevec.”

Mr. Jensen is only one of dozens of medical success stories in 2004 that were ignored by the press and politicians as they sought salvation in Canada, where Gleevec is rationed. There were others:

1. The first of a new class of antibacterial drugs in over a generation approved by the FDA for the treatment of several respiratory-tract infections.

2. In asthma, companies are working on new anti-inflammatory therapies targeting ten different genetic pathways. According to researchers, medicines based on this research enhance the prospects for a curative treatment.

3. Genetic tests show that 50 percent of women do not respond to tamoxifen, a generic drug, used to prevent the recurrence of breast cancer. This means that the day of “cheaper is better” drug formularies are nearing their end, to be replaced by personalized medicine.

Last year, life expectancy rose to 78 years, powered by yet another decline in the number of deaths due to cancer, heart disease and stroke. We are living longer lives with fewer afflictions largely because of the wider and novel use of newer medicines. The more we spend on drugs — still only 10 percent of total health care — the better and longer life is.

The problem is, policy-makers wishing to expand the role of government in running health care eagerly wait to enact price controls on Medicare. They talk of government “negotiating” drug prices for what will be about 60 percent of the total drug market. What they mean — if they refer to Medicaid or Veterans Affairs pricing — is a fixed ceiling price for drugs, limits to how much prices can go up and cheapest-is-best drug formularies.

The impact of such price controls, according to a study released by the Manhattan Institute Center for Medical Progress, is the complete destruction of the future of medicine. Under the new Medicare drug benefit, the government will increase its share of drug purchases threefold, from 20 percent to 60 percent. If the government applies Medicaid or VA price controls to the Medicare drug benefit, it will reduce real drug prices by 67.5 percent, reduce research and development spending by 39.4 percent, or $372 billion, over the next decade and cost Americans 277 million life-years.

The fact is, we need to spend more money on better medicines for the most expensive illnesses. To be sure, drug and biotech companies should provide more information on the value of these new technologies, and drug development has to become more efficient. But given what miracles were made in 2004 and what’s in store, can the critics of private companies say that we would be better off than we are today after price controls destroyed medical progress?

Robert Goldberg is director of the Manhattan Institute’s Center for Medical Progress.