On July 16, 1998, the FDA cleared thalidomide for marketing as a
for inflammatory leprosy. (See the FDA Talk Paper online.)
Thalidomide was shown to cause severe birth defects in the early
Pregnant women, or women who are trying to become pregnant, should
therefore not use it. However, thalidomide is highly effective in
leprosy (in trials,
70 percent-80 percent of patients given it improved significantly,
versus 25 percent with sugar pills) — a serious condition for which no
comparably effective treatment
is available — as well as other immune disorders.
For this single approved use of thalidomide (leprosy), the following
restrictions have been put in place:
You, the patient, will be required to submit your name, address,
and health information to a special national registry of all patients
Your doctor must be enrolled in a special national registry before
s/he can prescribe thalidomide.
Patients — both female and male — must comply with mandatory
contraceptive measures. Specifically, you must use two forms of birth
control, one of which must be an IUD, the pill, Depo-Provera, or female
sterilization surgery, while the other may be a barrier method such as
a condom or diaphragm.
Thalidomide’s availability in the U.S. will be limited to 500
physicians and 500 pharmacists for the first three months — with a
promise that “registration ultimately will be more open.”
Weekly pregnancy tests must be documented.
Any personal privacy being sacrificed here? Mind you, the safety
where this drug is concerned are legitimate and important ones. Among
requirements, weekly pregnancy tests, in particular, are an excellent
necessary precaution. They are there because, if pregnancy is detected
early enough, the drug can be stopped before there is any risk to the
Let me repeat, because the implications of this are stunning:
be detected by a quick and easy test about 10 days after conception –
the menstrual period is even late, and quickly enough so that the
stop using thalidomide before the “sensitive period” of potential fetal
begins, thus avoiding the risk of her baby’s having thalidomide-related
In other words: for decades, thalidomide has been denied to
research upon its benefits has been systematically discouraged, on the
grounds that it is capable of causing birth defects — although birth
entirely preventable, even when a woman taking the drug becomes
and without resorting to abortion.
There is more. Thalidomide is potentially useful in cancer, AIDS, rheumatoid
arthritis, lupus, tuberculosis, macular degeneration (a common form of
blindness), and multiple sclerosis. Yet, the FDA has not approved its
for any of these serious and crippling diseases, because of the birth
It is criminal — or should be — that the nanny state has so long
such a widely useful and effective drug to people with devastating
like cancer and AIDS who desperately need it. The FDA’s historical and
paternalism on drugs that can cause birth defects is nothing short of
repellent and totalitarian.
There is a presumption operating here (the same prejudice that has
sometimes created inequality of opportunity for women in the workplace)
woman of “childbearing age” — regardless of whether she is single or
has undergone a hysterectomy, is a virgin, etc — is liable to be
pregnancy at any moment. It’s as if getting pregnant were an
and uncontrollable happenstance, a matter of rolling snake eyes in a
mandatory, mindless craps game.
Well, I have a news flash for the FDA: not all women bear children
time. What about women who are celibate, sterile, lesbians, or birth
control users? What about men, for that matter, who also have been
benefits of thalidomide and other such drugs? (Again, remember in the
thalidomide that even if a pregnancy does occur, tragedy and abortion
not the only available choices — if the drug is stopped, a healthy baby
still be born.)
What upsets me worst about this entire business is the government’s
idea that women — that patients in general — are mindless bodies, not
intelligent individuals. The FDA plainly believes that you and I cannot
be trusted to
take appropriate precautions (such as abstinence or birth control) when
doctors tell us it is necessary to do so. American adults who have AIDS
or multiple sclerosis or developing blindness are treated as if they
irresponsible children, whining to play unsupervised with guns: they are
summarily denied access to a powerful and effective drug that, used
according to a doctor’s directions, could treat their conditions safely.
Women (including fertile women in sexual relationships with men) and
who can benefit from thalidomide treatment should be able to choose for
themselves whether to use it or not. It’s a plain civil liberties issue.
- Report from “Thalidomide: Potential Risks and Benefits” Workshop,
September 9-10, 1997 (covers many above-discussed topics and concerns).
- American Medical Association’s page on thalidomide (excellent):
- Celgene, the manufacturer of thalidomide. Also check here.
- Thalidomide and AIDS, brain cancer, prostate cancer, and other diseases:
- Thalidomide Primer (scroll all the way down the page)
- The FDA’s medical review of thalidomide for leprosy
Store favorite sites on the Web
Ad Hoc Incredibly Useful Site Award: Ever logged on so you could hit
great Web site you happened upon last week, only to discover that you’ve
bookmarked it at work, but not on the home machine you’re sitting at?
surfing from a public computer at a cybercafe, without ANY of your
“favorite places” handy? For those of us who go online from two or more
and maybe even use more than one browser, it can be infuriating trying
track of the sites we want to revisit. At MURL you
can store all of what Netscape calls your bookmarks and Explorer calls
favorite places together in one accessible spot right there on the Web.
John Keane, a leading authority on the recovery of lost and stolen
has a Web site for his pet-retrieval company, Sherlock Bones. Keane offers extensive,
tailored pet-recovery plans, which can include features like vet, animal
hospital, and shelter alerts; preprinted posters with your pet’s
photograph; and database-generated, preaddressed postcard mailings
targeted to homes in your neighborhood. Also available on the site is
advice about protecting
your pets, what to do if you lose an animal, what to do if you find one,
basic first aid. You can email Keane.
Microsoft breaks into homes
Microsoft has just launched HomeAdvisor, a free Internet-based
service. Search for agents, homes, loans, and neighborhoods by your
criteria; sign up for tracking services to receive free email updates on
homes that meet your needs or on loans for which you qualify. You can
advice on budgets, inspections, negotiations, and closings. My only
question: will they bundle Windows98 with your new house?
Are you just in a horrible mood a lot lately, or should you start
about looking for help? New York University’s psychiatric department has
Web site that offers a wide
of public mental-health resources, including free online screening tests
anxiety, depression, attention deficit disorder, and sexual disorders –
that one comes in male and female versions. The tests are nondiagnostic,
course, but they can probably tell you whether it’s worth getting a
checkup. Or, if
you’re feeling cynical, they may just give you big laffs. (Note that
assessment can be unclear: three “anxious” responses out of 10, say,
return dark comments about those three rather than encouraging ones
the other seven. So don’t let the tests make you crazy.)