On August 21st, the official version of the proposed rule was released, and while some of the problematic language about contraception and the beginnings of life was removed, the new version did little to quell concerns that the move was designed to limit women's access to reproductive health care. Framed by HHS as protecting "physician conscience" -- prohibiting providers from being forced to provide procedures such as abortion and sterilization to which they may object on moral or religious grounds -- the officially proposed rule is broad and ill-defined enough to leave considerable room for debate about what it would mean in practice if approved.
Although protections of physician conscience already exist in federal law, the HHS proposal expands the list of who would be covered by the protections to include support staff who are not directly involved with performing "objectionable" procedures, such as those "whose task it is to clean the instruments." The effect of this expansion would be to prevent federally-funded clinics and other entities from refusing to hire or being able to fire or discipline those who object to performing even basic and necessary general support services.
While the leaked proposal made clear that it would allow providers to define abortion however they liked - extending to forms of contraception that could hypothetically but have not been proven to at times prevent implantation of a fertilized egg - the official release does not address the definitions of the protected procedures at all, despite explicitly defining less controversial terms such as "individual" and "workforce." Lacking more explicit support for medically accepted definitions of contraception and abortion, the proposal might be interpreted to override state provisions - for example, those that require even Catholic hospitals to provide or refer for emergency contraception. Others have suggested that the proposal may jeopardize Title X-funded providers of family planning services.
HHS Secretary Michael Leavitt has claimed that the proposal was not "intended" to affect access to contraception or abortion, while neglecting to explain why the proposal would be needed if it is intended to apply only to abortion as currently medically defined -- as providers are already protected from being forced to perform this procedure. See this previous post from Emily Douglas for more discussion of how the proposed rule may limit access to reproductive health care despite Leavitt's statment that the proposal is only meant to address "the legal right medical practitioners have to practice according to their conscience and patients should be able to choose a doctor who has beliefs like his or hers."
HHS Obfuscates During Commenting Period
If you're left scratching your head about the justification for the proposed rule thus far, there's more. In a previous post for RH Reality Check, I described Leavitt's misunderstanding -- or willful mischaracterization -- of his own justification for the new rule, the ob/gyn certification issue. Leavitt has repeatedly claimed that without adopting the new rule, ob/gyns who object to abortion might lose their certification. The certifying body, the American Board of Obstetrics and Gynecology, has clearly stated that this is not true. ABOG explained this to Leavitt in a letter this March, but released a public letter to the Secretary when the official proposal was released, calling it a "the grossly untrue and unfair allegation."
The obfuscation doesn't stop with Leavitt's rationale, however -- it has apparently extended to technical issues on the proposed rule as well. HHS has repeatedly made it difficult for advocates to follow and respond to the conscience discussions, starting with Secretary Leavitt's initial blog post on the issue. Posted on August 7 at one URL, the web address changed by August 9 after a flood of comments opposing the proposal, and changed again by August 14. Visitors to the blog who had been referred to the initial URLs received only a "not found" error - until the URL was later reused for the Secretary's third post on the topic on Aug 21. I received a tip from a technical staffer that the number of comments "caused problems with the blog and they had to import the post multiple times." It is not at all clear why that would be the case or require a URL change.
These problems have carried over into the public comment period. A lengthy delay preceded the posting of the official docket and the release of submitted public comments. HHS released the proposed rule on August 21, and appeared in the Regulations.gov system for public comment on August 26; the public comment period officially opened on that day, and ends on September 25. But on September 3, the URL and docket number for the rule changed. A helpful Regulations.gov representative explained that this occurred because the site first posts a temporary docket, and the agency (HHS) later creates a permanent docket. I was assured that any comments made on the initial release would carry over, but many organizations and individuals who had publicized the comment period may have been sharing a link for rule that will no longer work. (The correct URL for submitting your comments is presently http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=HHS-OS-2008-0011-0001.)
I was less satisfied with the response from HHS as to why, as of September 11 -- 17 days into the public comment period -- none of the comment submissions had been made available for public viewing. The Regulations.gov staffer indicated that this was because HHS simply hadn't done it yet, stating "The agency has not yet posted any of the comments submitted," and referring me to the docket for the contact information of the specific person at HHS who is supposed to address any questions. I received no immediate response to my email, but discoverd that overnight on the day of my email, more than 1,100 comments suddenly appeared on the site. The response that did arrive to my query as to why no public comments had been posted was as follows, in its entirety: "Please use procedures in the Federal Register to ask questions about the conscious [sic] regulations.”
Advocates Talk Back
Although the comments are not very easy to browse, you can read the submitted comments (1,315 of them as of this writing) here. While some comments are in support of the proposed rule, many express objection. Some commenters have asked that health care providers be required to post notices as to which procedures, drugs and services they refuse to provide. Others note the problem of rural and underserved communities and low-income women where access to reproductive health care may be nonexistent if local providers "exert her/his moral authority on that community."
The lack of definition in the proposal seems to be a concern on both sides of the issue. One supporter of the proposal notes the lack of definition, explaining that "Leaving 'abortion' undefined is a two edged tactic. It might serve to allow these regulations to be instituted, but unfortunately it will lead to very uneven application of the non-discrimination regulations." Another commenter who objects to move asks that "At a minimum, the regulation should include explicit language clarifying that birth control is not at risk and that our current reproductive rights, guaranteed by law, will not be jeopardized."
If you would like to submit your comment prior to the Sep 25 deadline, please go to view the proposed rule and make your comment online. The proposal document also contains instructions for submitting comments via regular mail.
]]>For much more information on the new regulations, click here.
Leavitt continues to either misunderstand or deliberately misrepresent the certification issue as a primary argument for the introduction of the proposed regulations. He writes:
This became a topical matter when the American College of Obstetricians and Gynecologists (ACOG) issued guidelines that could shape board certification requirements and necessitate a doctor to perform abortions to be considered competent.
Physician certification is a powerful instrument. Without it, a doctor cannot practice the specialty. Putting doctors (or any one who assists them) in a position where they are forced to violate their consciences in order to meet a standard of competence violates more than federal law. It violates decency and the core value of personal liberty. Freedom of expression and action are unfit barter for admission to medical employment or training.
As Secretary of Health and Human Services, I called on the organization that oversees Ob-Gyn board certification to alter its guidelines to assert that refusal to violate conscience will not be used to block board certification. Their answer was dodgy and unsatisfying.
The American Board of Obstetrics and Gynecology (ABOG) is the certifying organization for ob/gyns, and has clearly stated since at least March of this year that refusal to perform or refer for abortion would have no bearing on issuance or renewal of provider certification. As this NPR piece documents,
Norman Gant, executive director of the certifying board, says HHS got it all wrong.
"They took two and two and came up with five," he said.
Gant, who didn't respond sooner because he was out of the office, backed up what ACOG spokesman Gregory Phillips said Tuesday, which is that the ethics committee opinion regarding referrals is not a binding portion of the college's ethics code, and therefore not a factor in the decision about board certification.
"We do not restrict access to our exams for anyone applying for initial certification, or maintenance of certification, based on whether they do or do not perform an abortion," Gant said. "We do not base this upon whether they do or do not refer patients to an abortion provider if they do not choose to do abortions."
Gant has publicly released his organization's response [PDF] to the issuance of the official regulation, in which Leavitt again refers to "the potential to force physicians to either violate their conscience by referring patients for abortions (or taking other objectionable actions) or risk losing their board certification." In his response, Gant states that he is:
"both shocked and very dismayed at the grossly untrue and unfair allegation that:
"...action by the American Board of Obstetrics and Gynecology...had the potential to force physicians to either violate their conscience by referring patients for abortions (or taking other objectionalbe actions) or risk losing their board certification."
The "subsequent action" to which you refer is totally unspecified in the Release. Moreover, your allegation is directly contrary to the advice I provided you in my letter to you of March 19, 2008, which expressly stated:
"The American Board of Obstetrics and Gynecology has taken no stand, pro or con, against individual physicians who choose to or choose not to perform abortions or to refer patients to abortion providers.
Moreover, such an issue is not a consideration in the application or in the examinations administered by the American Board of Obstetrics and Gynecology in any of its certification or in its Maintenance of Certification requirements or examinations."
Gant goes on to challenge Leavitt, essentially, to prove it:
In none of our various communications with you and your Department have you provided the American Board of Obstetrics and Gynecology with "even one" instance of the discrimination of which you have publically accused it in your Press Release, let alone any supporting documentation. My careful and comprehensive review of the ABOG files does not disclose "even one" instance of a physician who was denied certification or recertification, or whose certification was revoked, because the ABOG allegedly required that physician, as you have charged, to violate his or her conscience by referring patients for abortions.
The ABOG has previously and privately requested you to provide it with any cases or documentation you have to support your accusations so that it could know by whom it has been accused and for what offense. By this letter, which we are releasing to the public and the press, we again ask that you provide evidence supporting the serious and damaging charges you have made.
In other words, ABOG has clearly restated that certification is not at issue if a provider refuses to perform or refer for abortion, and is challenging Leavitt to provide any evidence that this is a real justification for the regulation, which he has thus far failed to provide. Gant goes on to request that formal hearings be held for receipt of public comment so the the "intent and full implications of any proposed Regulations governing ‘conscience rights' may be fully understood."
Gant also notes that it would provide "a public forum in which the allegations against the ABOG may be refuted, and will offer an opportunity for a complete consideration of the implications of the conduct the Regulation would impact, including, but not limited to, considerations of malpractice liability and the implications on women's health care."
]]>This piece was originally posted at Our Bodies Our Blog.
Combine girls, vaccines, and sex, and you apparently get a recipe for sensationalism and poor reporting. CNN last week featured a piece, "Should parents worry about HPV vaccine?" which notes that "Gardasil has been the subject of 7,802 'adverse event' reports from the time the Food and Drug Administration approved its use two years ago."
What the article doesn't explain is how the Vaccine Adverse Event Reporting System (VAERS) system works. Reports to VAERS can be submitted by anyone, and are not verified or definitively linked to the vaccine without further investigation. This understanding was not demonstrated by the piece, which simply conceded,
"The company said in a statement that an adverse event report 'does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination.'"
more/different side effects reported after a drug is approved (in the "post-marketing" period) due to the numbers of individuals involved. For example, if a drug causes death in 1 in 500,000 people, and was tested in 2,000, the possibility of the drug causing death is not likely to be realized until it is on the market and prescribed to a large population.
On the other hand (and unmentioned in the CNN article), many adverse events may occur that are not reported. "Post-marketing surveillance" - including analysis of reports from those who have received the drug or vaccine after it has been approved - is a crucial aspect of safeguarding the public from dangerous drugs. Because individuals and physicians may not associate an outcome with the vaccine, and many individuals may not realize that they are allowed to submit reports directly, underreporting of effects is both possible and likely. The FDA uses this surveillance system to make changes to labels, educate physicians about risks, and re-evaluate their approval of a drug or vaccine, so it remains important that adverse outcomes are reported, despite the cautions about making judgments based on raw numbers of reports and difficulties in later determining which of those outcomes were directly linked to a specific drug, vaccine, or other product.
Habladora at Feministe has an excellent summary
of how CNN's piece omitted crucial information in favor of drumming up
parental anxiety, touching on many of these same issues. She notes:
"Finally, CNN presents us with the terrifying story of a teenager who developed pancreatitis not long after taking the vaccine. While I am not insensible to how horrifying such a serious illness would be for a young girl and her family, it should be CNN’s responsibility to verify whether or not her fear that it was related to the vaccine could be founded - by researching how many of those incident reports dealt with pancreatitis, for example, or other autoimmune diseases. This type of reporting is important, after all, since it could impact women’s decisions and, consequently, their health."
This approach is not limited to CNN - Judicial Watch is currently featuring the large, bolded headline, "Judicial Watch Uncovers New FDA Records Detailing Ten New Deaths & 140 'Serious' Adverse Events Related to Gardasil." However, the CDC has reported that of the 10 deaths they have analyzed, they could not establish a causal relationship between the vaccine and the deaths, and notes that "While Gardasil was being tested in the U.S. before it was licensed, 10 people in the group that received the HPV vaccine and 7 people in the placebo group died during the trials. None of the deaths was considered vaccine-related."
In their report, Judicial Watch also suggests that Gardasil wasn't adequately tested for adverse effects because the comparison placebo vaccine contained an aluminum "reactive, potentially harmful substance." Without reading the original studies, this probably makes the comparison more valid instead of less, because the real vaccine also contains an aluminum compound (as do many other vaccines), and omitting it from the placebo vaccine would have skewed the comparison by confusing adverse effects of the aluminum with adverse effects of the actual vaccine substance.
I have to wonder if we'd be seeing the same level of fear-mongering if this were another vaccine, if opponents hadn't suggested that it would cause young girls to become sexually active and that girls from "good homes" don't get HPV. Yes, of course we should keep watch when a new drug, vaccine or product is approved and is targeted to women. Of course we should attempt to tease out real and serious side effects that didn't appear in the smaller trials, and be wary of the financial motives companies have to put the best light on their product. Of course we should be aware of mandates for vaccination and ensure that adequate information and opt-out provisions are available. It may still turn out that there are serious issues with Gardasil that warrant a different assessment of the risks and benefits. However, incomplete and inaccurate reporting and misrepresentation of the science does nothing to assist women and families in making decisions about vaccination and safety.
For further discussion, see Gardasil: What you need to know about the HPV vaccine and this previous OBOS blog post.
This post originally appeared on Our Bodies, Our Blog.