Thursday, May 2, 2013

Horns of the dilemma: value to cancer patients versus profits to drug companies.

The pharmaceutical industry has recently developed several drugs that produce remarkable benefits in certain cancers. These include both small molecules and monoclonal antibodies or other macromolecules.  However, in some cases these life saving drugs come with astronomical price tags of $100,000 per year or more. Patients and insurers have long been concerned about these costs, but now oncologists have also started to rebel (1). This began with a group of physicians at Sloan Kettering cancer center in NY who objected to the high price of Zaltrap®, a new drug from Sanofi. It has since spread, and many oncologists support a commentary in the April 25 issue of the journal Blood (2) advocating for lower drug prices. In addition to Sanofi, criticism has been leveled at Novartis the maker of Gleevec®, as well as at other producers.

One of the problems in this area is the increasingly fragmented nature of the cancer drug market. As studies in cancer genomics have progressed the existence of multiple cancer subtypes has emerged, with each potentially requiring a different therapeutic approach.  One of many examples of this is the recently published study of endometrial carcinoma (3) that has divided this disease into four distinct categories and also revealed previously unsuspected relationships to some forms of breast and ovarian cancers. Unlike ‘classic’ cytotoxic anticancer drugs like doxorubicin that are used in a variety of cancers, many of the newer agents are highly selective for particular cancer subtypes. Since each subtype involves far fewer patients than previous broader cancer classifications, the industry response has been to raise prices. The argument, of course, is that this is necessary to cover R& D costs.

The issue of drug pricing came to the fore at the recent Biotechnology Industry Association meeting in Chicago, as reported in C&EN (4). Business oriented consults advocated that drug and biotech companies carefully consider future value and reimbursement issues before proceeding too far down the development pathway. However, this approach would put profit considerations squarely in opposition to the advance of science. As understanding of cancer (and other diseases) advances rapidly it should become possible to design drugs that have dramatic impacts on individual disease subtypes. Gleevec® is the current hallmark of this, since it has revolutionized therapy of chronic myelogenous leukemia but is useful only in this disease plus a few rarer cancers.

We seem to be coming to a sort of end game with current models of cancer drug development.  Patients need advanced drugs but our health system cannot sustain outrageous costs. Some new ideas about drug development strategies have been published recently (5) and more thought needs to be given to this critical area.

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