Back to the Future

Misguided and misleading labeling changes, unscientific drug use rejections, dubious orders and announcements. And that's just the FDA.

In July of 2000 a controversial FDA draft guidance is distributed. The draft proposes labeling changes for all combined oral contraceptives. Many industry leaders call these changes overly restrictive and lacking in important information about health benefits associated with OC [oral contraceptive] use. Based on this feedback, the proposed labeling changes are revised, and the draft is redistributed in 2004.

Unfortunately, even the revisions are misguided. A few of the problems:

One complaint regarding the proposed labeling is a lack of balance and recency. The proposed labeling is simpler than the existing labeling, but a great deal of recent literature has been ignored, while many of the data cited in the draft guidance are 1-2 decades old....

Another complaint is the lack of information regarding potential benefits of OC use. The only benefits listed for OCs are more regular menses, less blood loss, and less dysmenorrhea.

[T]he recommendation to exclude the prevention of endometrial and ovarian cancer as a potential benefit of OC use is particularly egregious, given the ample evidence for this benefit.

In December of 2003 the FDA advisory committees on Reproductive Health Drugs and Nonprescription Drugs votes 23-4 to recommend Barr Labs' emergency contraceptive Plan B for OTC status. However, in May 2004, the FDA rejects Barr's application. In the words of one of the voting members of the committee:

We find it offensive that religious ideology and partisan politics have been introduced into the decision-making process regarding a public health issue.

...

[T]his action [rejecting Barr's application] is a flagrant example of the intrusion of religious ideology and conservatism activism--enveloped in a thin veneer of pseudoscience--into what should be a scientific and empirical examination of the evidence by an objective, secular, and unbiased expert government advisory committee.

And the American College of Obstetricians and Gynecologists:

[F]inds the US Food and Drug Administration's failure to approve over-the-counter status for Plan B, despite the nearly unanimous recommendation of its own advisory panels, morally repugnant.

The Food and Drug Administration's (FDA's) action is a tragedy for American women, and a dark stain on the reputation of an evidence-based agency like the FDA.

This decision to ignore an advisory panel's assessment of the scientific evidence is not only rare, but it gives credence to recent criticisms that political interference is hampering scientific review within federal agencies today.

Finally, James Trussell, director of the office of population research at Princeton University and a member of the advisory committee, comments:

[T]he agency never raised the issue of label comprehension among young teenagers when it approved other products to be sold over the counter. "The White House has now taken over the F.D.A.," Mr. Trussell said.

On November 15, 2004 the FDA announces labeling changes for mifepristone (RU-486).

Unfortunately, the changes are unclear, bordering on misleading. Infections, sepsis, ectopic, bleeding and death are side effects of ending a pregnancy, not of the drug mifepristone.

On November 17, 2004 the FDA orders the addition of a "black box" warning to the labeling of Depo-Provera. The warning highlights that prolonged use of the drug may result in significant loss of bone density, and that the loss is greater the longer the drug is administered. This bone density loss may not be completely reversible after discontinuation of the drug. The FDA's justification for this action: to ensure that physicians and patients have access to this important information.

Of course, physicians and patients have had access to this information for decades. Least we forget, Depo-Provera has been available, worldwide, since the 1970s. [It's only been available in the U.S. since 1992.] Moreover, there's been access to the actual information about using this method and its impact on bone density*:

The degree and reversibility of bone loss with DMPA [Depo-Provera] are comparable to those observed with lactation [breastfeeding], which suggests that a long-term increase osteoporosis [brittle bones] risk in DMPA users is unlikely.**

In the meantime:

If you need to get the Pill.....

Pharmacists interrogate you and demand a justification; expect your justification to comply with their religious beliefs; refuse to fill your prescription and to refer you to another pharmacist; ignore requests to release your medical information to another pharmacist (one you've found on your own); and steal your prescription and refuse to give it back.

If you need EC.....

The Christian Coalition of Alabama (CCA) challenges the state's mandate to make emergency contraception (EC) available to women. CCA's stated goal is to change the health department's policy on EC. Also, Rep. Aderholt (R-Ala.) says ...he has "done all he can" to urge the health department to stop distributing EC....

As a result of the FDA's unscientific action, Barr is forced to resubmit its application to sell Plan B OTC only to women age 16 and older. According to Dr. Scott Spear, chair of the national medical committee of Planned Parenthood:

...Barr's new proposal is a "response to the political realities created by the FDA," adding that FDA's call for an age requirement for OTC status for Plan B is "bogus"....

If you expect your medical records to be private.....

Attorney General Ashcroft demands access to women's confidential medical records...and a whole lot more:

[A] subpoena filed on December 22 demanded that a doctor at New York Presbyterian Hospital identify "all persons to whom you have taught" the D and X method [dilatation and extraction, a surgical termination technique] as well as "all persons who have started using and teaching" it in the last five years. The subpoena also called for the medical record numbers of the "at least 50" women who had undergone such abortions after 19 weeks of pregnancy, as well as the records of women who had had such abortions because their fetuses had trisomy 18, a severe genetic disorder from which the vast majority of affected infants die in their first year of life, or anencephaly, a brain defect that results in death before or very soon after birth.

...

Of particular concern ... is the demand that doctors provide the names of their colleagues--including those not cited in the original [DOJ] suit.

If you need some assistance with paying for medications.....

For 2005, the proposed $2.4 trillion budget leaves family planning funding to stagnate while doubling money for abstinence-only programs.

[D]espite the great dividends--economic and otherwise--generated by family planning, the 2005 budget request for Title X, the U.S. family planning program for low-income men and women, is the same as the total for last year. At the proposed funding level of $278 million, the program's funding is not keeping up with inflation, and currently provides care for only about half of the low-income women and men who need family planning services.

Unfortunately:

Very few abstinence-only-until-marriage programs have been rigorously evaluated and, thus, there is no compelling evidence to date that they actually change sexual behavior. In the new U.S. budget, the funding level proposed for abstinence-only-until-marriage programs is doubled from last year, from $140 million in 2004 to more than $270 million in 2005. Money for "marriage promotion" is also increasing, as part of the President's proposed $1.5 billion marriage initiative.

If you'd like to learn facts.....

In Texas new sex-education textbooks are likely to ignore birth control:

The 15-member Texas Board of Education is considering and will likely approve four books, all of which extol the virtues of abstinence. Three make no mention of contraceptives at all while one makes passing reference to condoms.

If you're a woman and you'd like to receive health care.....

At the federal level, refusal to treat [female patients] laws are enacted and amended. Initially, in 1973, the law (42 U.S.C. 300a-7) is very narrowly tailored to apply only to doctors, and residency training programs, and a religious or moral basis for the refusal is required. In 1996 an amendment (42 U.S.C. 238n) that no longer requires any justification for the refusal to treat is passed.

In 2003, the Abortion Non-Discrimination Act (ANDA) (HR 3664) is passed by the House. ANDA radically changes the 1996 amendment by significantly expanding the existing refusal clauses to include not only doctors but other health professionals and health care entities--HMOs, health insurance plans, etc.

In 2004 the House passes the fiscal year (FY) 2005 Appropriations bill (HR 5006) funding the Departments of Labor, Health and Human Services and Education ("Labor-HHS-Education"). This Bill contains the Federal Refusal Clause (FRC) amendment [pdf, page 99]:

Under FRC, any federal, state or local law or regulation that preserves access to abortion services and information could be deemed discriminatory and thus not enforceable, unless the government body enforcing the law would be willing to sacrifice all federal assistance made available through the Labor-HHS-Education Appropriations bill. Any health care entity, including individual physicians or other health care professionals, hospitals, provider-sponsored organizations, HMOs, health insurance plans, or any other kind of health care facility, organization, or plan, could be allowed to refuse to perform, pay for, provide coverage of, or refer for abortion.

FRC's enforcement mechanism goes beyond ANDA's (which affects funding for all health related activity) to include all funding appropriated in the Labor-HHS-Education Appropriations bill. FRC also discriminates against states' authority to pass and enforce state laws and constitutional protections safeguarding a woman's right to chose.

In 2003, the RU-486 Suspension and Review Act is introduced [companion bills in the House (HR 3453) and Senate (S 1930)].

At the state level, 45 states have passed legislation allowing individual health care practitioners to refuse to perform abortions. Forty-one states have extended this right of refusal to health institutions (21 of these apply to any health facility and 20 apply to hospitals only). Nearly half of state abortion refusal laws require a religious or moral basis for the refusal (22 of 45 states). The majority of state exemptions require the service to be provided if a woman's life is in danger.

Bottom line: It is becoming increasingly apparent that, if you are a woman of reproductive age, you don't really matter.


*I will review the pertinent studies in a future post. [In my book, see page 194.]

**Speroff L. Bone mineral density and hormonal contraception. In: Dialogues in Contraception. Summer 2002;7(7):2-3, 8.