healthcare (5) the drug companies

Stephen Colbert, in a recent "Cheating Death" segment concluded that placebos become more effective whenever the drugs being tested prove ineffective. This came in the midst of several related news items. One of these, of the good news/bad news variety concerns the board of a drug company's firing of the chief executive and top research scientist and some others plus the resignation of a few more who had "failed to put in place adequate protocols and controls" for their studies and had given investor's unsubstantiated claims about new blood tests to detect Down syndrome (NYT, 9-29-09). The item appeared in the Business rather than in the Science section of that day, where some item might have alerted more readers.

The other item, also of a good/bad news nature is however more disturbing and deservedly was a front page article entitled "Where Progress Is Rare, the Man Who Says No." (NYT, 9-16-09). That man is Richard Pazdur M.D. of the Food and Drug Administration and his No's are to requests for approval of cancer drugs that "cost a fortune while giving patients few, if any added weeks of life." One analyst is quoted as saying that the good doctor is made the scapegoat for an "industry that is not producing that many good drugs." Guards are now posted at the FDA meetings to protect him and his fellows committee members. In fact, an accompanying graph shows that on average 3-4 drugs have been approved, or 29 since 2001 (during the Bush years) and 27 during the Clinton years so that it doesn't appear a question of political influence. It seems there are a lot of different drugs that did not actually lower the rate of cancer deaths. Yet the number of approvals is very small when compared with the 860 medicines that are being developed by the industry.

Dr. Pazdur reminds me of another FDA physician, Frances Kelsey, MD., PhD., who almost single-handedly kept thalimodide out of American pharmacies long enough for the catastrophic birth defects in about 8,000 babies in Europe to justify her opposition. These effects led Congress in l962 to require rigorous testing before a drug can be approved. The makers of this drug had not performed such tests and they refused to answer Kelsey's questions. But it is clear that even now drug companies seek to circumvent the law or simply lie about the test results. Meanwhile derivatives of the drug are being tested for other uses and has been approved, with stringent restrictions, as a painkiller for bone-marrow cancer patients. The drug is so dangerous that male users should use condoms when having sex. Aren't there safer painkillers?

As some 560.000 people are expected to die from cancer in 2009 there is a great demand for the miracle cure and insurance companies are eager to have more drugs as that could lower the cost of reimbursements. But Frances M. Visco, president of the National Breast Cancer Coalition reportedly stated: "We want drugs that prolong survival, not drugs that improve test results," and the head of a Cancer Hospital feared that the pressures on the FDA have lowered standards for approval. Also discussed is an instance that is similar to the Down Syndrome research in that a company had a drug used in a hospital in France and then blamed the hospital for its negative results, a practice that biotech executives often use to hide their own failures in order to be able to raise money from investors.

The article contains a photograph of people with placards demonstrating against the FDA and Dr Pazdur, who has been called a mass murderer, having created another Holocaust. It appears, fortunately, that the American Cancer Society recognizes "his outstanding service to the oncological community." One may thus ask why there is such a widespread criticism of Dr. Pazdur and the answer clearly can be found in the activities of thwarted biotech execs and investors who have taken to the media to mount their attacks. Personally I am convinced that drug advertisements promising cures for everything prey on the hopes of the sick who only have to ask their physician whether a drug is safe for them to take and by minimizing possible dangers with misleading statistical correlations (discussed in my Healthcare (2) blog, 6-4-09). Worse still are the media's talking heads whose politics, greed and ego seize upon any issue that may maintain their audience, for ex., with a line like "it is not that the government will stand between you and your doctor [under Obama's Health Reform], but it already stands between you and the medicine that cures."

Incidentally, why should drug companies be exempted from major restrictions of the Anti-Trust Laws? Since when is monopoly good for "free" enterprise?

Addendum: in these healthcare posts, I return again and again to the problem of possible side-effects. Two weeks ago, driving along on our way to a birding spot I noticed a new sign on the lawn in front of a former research institute. I asked my son if he know what that (new) company produced and he said: "Side effects."