SUMMARY: The bill doesn’t offer a definition of what constitutes “significant medical risk,” which makes the claim hard to verify. The bill’s sponsor, and its authors, haven’t been very forthcoming with information to support that claim, or the implied claim that pill-induced abortion is riskier than surgical abortion. It’s true that physicians sometimes don’t follow FDA protocol when administering abortion-inducing drugs, but critics of the bill say doctors have a certain amount of leeway in how they prescribe drugs.
Analysis: SB298, sponsored by Sen. Gerald Allen, R-Cottondale, is one of six bills in the Republican-controlled Alabama Legislature that place new limits on abortion. Other bills under consideration would:
-- require an ultrasound before an abortion can be performed;
-- prohibit health insurance companies from providing abortion coverage;
-- prohibit Alabama from covering abortion under health insurance exchanges mandated by federal health care reform;
-- permit health care providers to opt out of procedures, including abortion, on conscientious grounds.
Like some other bills in the package, SB298 is modeled almost word-for-word from legislation provided by Americans United for Life, an anti-abortion group based in Washington, D.C. Nearly identical bills were recently introduced in Arkansas and Oklahoma.
The Alabama bill states mifepristone -– an abortion-inducing drug, once known as RU-486 -– “presents significant medical risks to women,” that medical abortions are “associated with an increased risk of complications relative to surgical abortion,” and that “physicians routinely fail to follow the mifepristone protocol as approved by the FDA.”
The Star’s attempt to verify these claims produced as many questions as it did answers.
The term “significant risk” is not defined by the bill, nor does the bill provide information and sourcing for the claim that medical abortions from mifepristone present “increased” safety and health concerns for women “relative to sur-gical abortion.”
Repeated efforts to reach Allen, over the course of three days, for clarification on the wording of the bill were un-successful.
The wording for the claims on the misuse of the FDA protocol for administering mifepristone, however, is much clearer, and it does have a source. Americans United for Life’s model legislation points to a 2006 court case from Ohio –- Planned Parenthood Cincinnati Region v. Taft -– in which the plaintiffs, Planned Parenthood, acknowledged not using FDA’s recommended protocol of administering 600 mg of mifepristone under a physician’s supervision and administering a follow-up of 400 mg of mifoprostol two days later.
Case closed, right? Not exactly.
Helene Krasnoff, a senior staff attorney for Planned Parenthood Federation of America, acknowledged that the group’s method of administering mifepristone doesn’t follow the FDA protocol, which is based on clinical trials from 1996.
“Our method is more effective, costs less, has fewer side effects and can be administered longer in(to) the pregnancy,” Krasnoff said.
Planned Parenthood Cincinnati v. Taft states that the method used by Planned Parenthood -– using 200 mg of mifepristone and taking 800 mg of mifoprostol 48 hours later at home –- is approved by National Abortion Federation and the American College of Obstetricians and Gynecologists, also known as ACOG.
A practice bulletin published by ACOG in October 2005 states that research “based primarily on good and consistent scientific evidence” suggests the method, compared to the FDA’s protocol, was “associated with a decreased time to expulsion, fewer side effects, improved complete abortion rates, and lower cost for women with pregnancies up to 63 days of gestation.”
The operative word in the legislation is “fail,” but physicians who follow the advice of Planned Parenthood, the National Abortion Federation and the American College of Obstetricians and Gynecologists aren’t exactly “failing” to do anything they are legally required to do, the bill's critics say.
According to Krasnoff, when the FDA approves a product, the agency doesn’t have a jurisdiction on how to administer the drug. That’s up to individual states to mandate.
Krasnoff said it’s common for physicians to prescribe so-called “off-label” uses of FDA-approved drugs. By the legislation’s definition, she said, any drug prescribed to children would be unsafe, as the FDA doesn’t conduct clinical trials on minors.
“There’s no incentive for manufacturers” to continue trials after a drug is approved, Krasnoff said.
As for the “significant risk” mifepristone poses to women seeking medical abortions, Americans United for Life’s legal team point to the drug’s label, which states “nearly all of the women who receive Mifeprex and misoprostol [the RU-486 regimen] will report adverse reactions, and many can be expected to report more than one such reaction.”
Kristi Hamrick, spokesperson from Americans United for Life, e-mailed The Star a document citing 1,070 “adverse events reported” by May 2006 associated with mifepristone as evidence of health risks associated with the drug. The listed events include six deaths, nine life-threatening incidents, 116 blood transfusions and 88 cases of infection. The group did not provide a more detailed explanation of the numbers, despite requests from The Star.
What’s not clear is how these numbers compare to other drugs, or what percentage of mifeprestone users experience these effects.
The numbers come from a staff report from October 2006 by the Criminal Justice, Drug Policy and Human Resources Subcommittee of the U.S. House of Representatives. That report cites a letter written by David W. Boyer, then the assistant commissioner for legislation of the FDA as the source for the statistics, but points out “accumulated case reports cannot be used to calculate actual incidences of adverse events or estimates of risk for a product, as the reporting of adverse events is a voluntary process with inherent underreporting.”
The Star’s calls to the Office of Legislation at the FDA, seeking more information on the numbers, went unreturned.
The bill’s claims of mifepristone’s risks “relative to surgical abortion” could not be verified, but according to Krasnoff, a survey conducted by the National Abortion Federation showed one-third of all women eligible for medi-cal abortions chose the option over surgical abortions, and the risks of medical abortions were statistically similar to complications from miscarriage.
The alternative method to administering mifepristone as approved by Planned Parenthood allows for medical abortions to be performed up to 63 days of the pregnancy. The FDA’s protocol is for only 49 days, meaning if SB298 is passed, the number of women eligible to choose a medical abortion would decrease significantly.
“It would be turning the clock back on medicine,” Krasnoff said.
Star staff writer Brian Anderson: 256-235-3548.
