From: sbharris@ix.netcom.com(Steven B. Harris) Subject: Re: breast cancer and alcohol? Date: Sun, 21 Sep 1997 Newsgroups: alt.support.menopause In <603kor$72e@ocean.silcom.com> joanliv@silcom.com (Joan Livingston Attorney at Law) writes: > Some of the "studies" that showed "no" increase in breast >cancer/estrogen/HRT were: > > -too short term to show up the cummulative effect of the >estrogens and/or other hormone medications. > > - included women who took any estrogen containing drug at any >time in their lives, such as 6 months of birth control pills when they >were 20 and thereby diluting the breast cancer incidence among those >who were taking it more steadily and later in life. > > Read carefully, Cathe, even my posts. > >Joan L. Comment: By and large the studies which show the increase in breast cancer mortality are those which also show a decrease in cardiac mortality, and total mortality. There is exactly as much evidence for the good effects as the bad, and for the fact that the good outweighs the bad for most women. I'm amused that the package insert for these things requires the company to say that there is evidence that the healthier women who took hormones in the epidemiological studies, were healthier to begin with than those who decided not to. Indeed. Hormone-taking women are slightly better educated, have fewer children, make more money, etc, etc. In fact, by gosh, they have a bigger risk for breast cancer to begin with, also. Except the FDA doesn't make the drug company mention that. Here's why not: the package insert for a drug is written by lawyers with lawsuits in mind, and balanced treatments of biological theories are not the purpose. Avoiding liability by overdoing the potential dangers is the purpose. This is to the drug company's best interests, and it's in the government's best interests, giving both deniability if the side effects hit the fan later. A package insert for a drug is very much like what the S.E.C. makes sellers of stock write for potential investors. The problem that arises from this kind of thing is that of all liability, however: when you critically examine evidence of benefits for an action without just as critically examining evidence for your risk, you take an unnecessary risk. Somebody ought to remind the FDA that there really are penalties for crying wolf and exagerating risks-- that it's not something you can do willy nilly without consequences. Not doing anything is risky, too. At least for the consumer. But the FDA is a political animal, and it knows that there are few consequences to IT in delaying approval of a drug too long, or making a drug sound nearly worthless, for too long. People don't think of themselves as dying from lack of drug, because usually they never know about the drug or the particular use for it. They think of themselves or their loved ones as having died of the disease. And so they have died of disease, but it's not the one they are thinking of. Calcification of the Government is not something you can write on a death certificate. The political penalties for delaying a drug too long are almost nil. By contrast, the political penalties associated with passing off on a drug too early, are immense. So which is the FDA going to lean towards? Steve Harris, M.D. |