Can we afford the future cost of cancer care?

Lung cancer researchers came up with an important discovery this week that has important implications for our health care finance system.

It turns out that just one in ten lung cancer patients respond to AstraZeneca's drug Iressa because only one in ten have a mutation of the epidermal growth factor receptor (EGFR) gene, which gets expressed at rates far beyond normal and triggers abnormal cell growth. Iressa (the generic name is gefitinib) inhibits EGFR.

Of course, that's not what AstraZeneca wanted to hear. Thanks to the tobacco industry, air pollution and other factors, about 200,000 Americans get lung cancer every year. It's a huge market. The company adroitly exploited that patient population when seeking approval for the drug. It gave tens of thousands of dying patients the drug in a "compassionate use" program, thus building a huge constituency to lobby for its approval. We now know why a small percentage of them responded.

However, that limited response has been used to justify marketing the drug to all lung cancer patients. Unfortunately for AstraZeneca, knowing which ones will respond by administering a test to see which ones have the EGFR mutation will cut its potential market by 90 percent.

There are a number of lessons to be drawn from this story. First, most major

cancers are not single diseases. People either develop multiple genetic mutations in a single cancerous cell type or each person's cancer falls into tiny subset of the broader category that we call, say, lung, breast or colon cancer. Which subset a patient falls into will depend on which gene mutates. The result is that any single drug will help only a small fraction of the overall patient population with that type of cancer.

This doesn't bode well for the future cost of health care. Every cancer in effect becomes a rare disease. As scientists hone in on the cancers that may be inhibitable with targeted therapies like Gleevec or Iressa, each drug will only help a subset of the total patient population.

Identifying in advance which patients will respond to a drug by genetically testing their cancer cells will either sharply reduce the drug manufacturer's sales, or force them to increase their prices to astronomical levels to get the returns they'd hoped for when they embarked on developing the drug.

Can health care insurers, Medicare, Medicaid and private health care consumers support this kind of targeted therapy? Don't forget that these targeted therapies don't kill cancer, they control it. That means that as patients live longer, they require long-term, perhaps permanent treatment with wildly expensive drugs.

The simple answer is no. The nation will either ration through price, or allow health care spending to gobble up more and more of overall economic activity.

Here's where it is important to recall that most of the knowledge about these genetic mutations and identification of drug targets was generated by researchers funded by the government. Even though drug companies spend lots of money developing drugs to inhibit these targets, the drugs' eventual pricing is driven by the overall economics of the industry, not the cost of developing the drug.

And those economics are exceedingly depressing, especially as one looks out over the medium and long term. Drug companies are coming up with fewer and fewer blockbuster drugs to justify their huge expenditures on marketing, advertising and wasteful research on me-too drugs (not to mention a profit margin that is the envy of every other industrial enterprise). Trying to squeeze the cash flow needed to support those wasteful activities out of targeted therapies for cancer -- the nation's second leading killer -- will bankrupt the health care system.

Most of the leading chemotherapy agents -- the earlier generation of cancer drugs -- were developed in the public sector. The coming collision between the rapidly evolving science of cancer and the financial needs of the drug industry suggests we may have to return to that model if the American people are going to be able to afford treatments based on knowledge they've already paid for with their tax dollars.

Posted by gooznews at May 1, 2004 11:36 AM