You know all those lawsuits now pending around the country charging that the Obama administration’s rule requiring most health insurance plans to offer no-cost contraception is a violation of religious freedom?
Well, a whole bunch of supporters of the rule are chiming in now to say that argument has no legal merit.
The dozen new suits, representing some 43 Catholic dioceses, universities and charities “have made a splash by virtue of their number, but when you take a moment to actually look at them, there’s nothing to see,” Sarah Lipton-Lubet, policy counsel for the American Civil Liberties Union, wrote in a blog post. “The rule is constitutional, it violates no federal law, and it’s incredibly important for women.”
Lipton-Lubet is talking about the rules issued in January (and amended in February to address the religious backlash) that require prescription contraception and sterilization services to be available without additional copays as part of most health insurance packages.
While those filing the lawsuits charge that offering the coverage (or even being forced to facilitate it) in violation of their religious belief runs afoul of the First Amendment’s guarantee of freedom of religion, Lipton-Lubet points out that the Supreme Court has already weighed in on the question.
“The Free Exercise Clause does not require any exemptions from a neutral law of general applicability. As the Supreme Court held two decades ago, in an opinion authored by Justice Antonin Scalia, to do otherwise would be to create a system “in which each conscience is a law unto itself.” Translation? If it applies equally and doesn’t target any faith, it’s not a First Amendment violation.”
(Backers of the church challenges, however, point to a more recent case, a unanimous ruling this past January, where the justices said religious organizations should have broader hiring and firing power than other businesses.)
But even setting the Supreme Court aside, pointed out Ian Milhiser of the Center for American Progress, more than half the states already require contraceptive coverage. And the issue has already been litigated at that level by the Catholic church — and the challengers lost.
In 1999, in California, Milhiser wrote, “five of the court’s six Republican justices held that, even if the law were examined under the strictest level of constitutional scrutiny, California’s contraceptive access law is constitutional.”
And even if the issues hadn’t been litigated before, the current cases are premature, says Nancy Northup of the Center for Reproductive Rights. That’s because the work on the regulations remains ongoing.
“This is the most cynical kind of political theater and nothing more,” she said in a statement. “Rather than working constructively with the Administration and allowing the rulemaking process to reach a resolution, these groups have chosen to grab headlines with a political stunt that will only burden the courts with untimely claims.”
But even though most religious-based organizations will have an additional year – until August 1, 2013 – to come into compliance with the new requirements, some are already taking action.
The 2,800 student Franciscan University of Steubenville in Ohio, for example, announced earlier this month that it would stop offering health insurance coverage for students this fall rather than comply with the mandate. [Copyright 2012 National Public Radio]
PHARMALOT’S, Ed Silverman, from the Publishers of PharmaLive.com, examines the state of DRSP (DROSPIRENONE) birth control and the FDA Advisory Committee hearings of 12.8.11.
“Three months ago, an FDA advisory panel voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and the drugs should remain on the market, albeit with added information about a risk of blood clots. The decision followed a long-running controversy - studies by Bayer, which sells the pills, found there is no risk, while other studies said risk is evident (see this).
But controversy also surrounded the meeting. Beforehand, the FDA yanked Sid Wolfe of the Public Citizen Health Research group from the panel due to an intellectual conflict of interest (read here). Afterwards, concerns were raised because four panel members held ties to Bayer, either as paid consultants or in the form of research funding, but the FDA did not disclose the conflicts, prompting the Project on Government Oversight, a watchdog group, to ask the FDA to convene an entirely new meeting (read this and this).
Now, a coalition of women’s health groups charges there were several irregularities that may well have altered the outcome. In a letter to FDA commish Margaret Hamburg, the coalition complains, in particular, that the key question panelists had to answer, which determined the outcome of the voting, was vague and confusing. And they maintain that several panelists who are practicing obstetricians and gynecologists may also have held intellectual conflicts that swayed their votes.
“Obviously, we can’t predict how people would have voted with different wording…,” the coalition wrote. “However, the vaguely (and, we believe, inappropriately) worded question and the difference in how conflicts of interest were handled raises very serious questions of bias.” The groups that signed the March 9 letter include the Jacobs Institute of Women’s Health, the National Research Center for Women & Families, the National Women’s Health Network and Our Bodies Ourselves.
The panelists were asked to vote on whether “the benefits of the DRSP-containing oral contraceptives for prevention of pregnancy outweigh their risks.” DRSP is drospirenone, which is a hormone contained in the Yaz and Yasmin pills. After voting, each panelist was asked to explain their vote, and the coalition noted that those who voted “no” explained that safer oral contraceptives were available.
However, the letter also notes that almost all of the 15 who voted “yes” indicated they voted on a comparison of risks and benefits compared to pregnancy, rather than on whether the risks and benefits of oral contraceptives containing DRSP outweigh risks and benefits compared to other oral contraceptives. These are two different issues, the coalition writes, the befuddled some panelists.
The coalition pointed to panelist Elaine Morrato, who voted “yes,” but said: “However, if the standard is to make a comparative, which… I just compared it in the absolute sense. I would agree that I didn’t see any benefit of the product that’s well demonstrated for Yasmin, perhaps for Yaz. And so if the regulatory standard would be that you’d have to demonstrate a comparative benefit, then I would vote no.” This would have changed the vote to 14-to-12.
Another panelist, Anne Burke, voted “yes,” and according to the letter, said: “I don’t think I was expecting it to be more effective than other pills on the market, and while I acknowledge that there does seem to be a moderate increased risk, it’s still lower than the risks of pregnancy. And like some other folks who have spoken, a no vote sounded like it would be - to take the product off the market. I’m not quite sure that’s necessary at this point.”
And panelist Julia Johnson voted “yes” and said: “I am significantly concerned regarding the most recent FDA study…I would like to see comparison with another U.S. study. I think that’s absolutely critical. I do not think there is one advantage for this pill over any other for use for women. If indeed there is truly an increased risk, then I would vote differently,” according to the letter. Both Johnson and Burke had ties to Bayer.
Meanwhile, seven other panelist are practicing OB/GYNs. “Given that practicing OB/GYNs routinely prescribe oral contraceptives, and that these physicians have likely made a decision to either prescribe or not prescribe/stop prescribing DRSP-containing OCs prior to the meeting, this certainly raises an intellectual conflict of interest as great as that attributed to Dr. Wolfe. Had they been ask to participate in the panel but not vote, as Dr. Wolfe was, this clearly would have resulted in a majority vote that the benefits do not outweigh the risks,” the coalition writes to Hamburg.
How so? Here is the math: If Wolfe voted no and at least one of the three panelist who expressed strong concerns voted “no” on the more specific question of whether the benefits outweigh the risks compared to other pills, the vote would have been 14 “no” and 13 “yes.” But if Wolfe and those with a financial conflict had not been allowed to vote, the final vote would have been 11-to-11. And if Morrato had been counted as a “no,” given her confusion, then the vote would have 12-to-10 against allowing the Bayer drugs to remain on the market, the coalition writes (here is the letter).
The coalition, however, stopped short of asking the FDA to hold a new meeting and, instead, wants Hamburg to review its policies “that resulted in biases” so a repeat does not occur. We asked the FDA, which previously indicated the POGO request for a new meeting would be reviewed, for a reply and will update you accordingly. [UPDATE: An FDA spokeswoman writes us to say the agency will respond directly to the coalition.]”
Birth control prices range widley from $100 to $1,000
However, you better ask about increased risks or side effects because you have to look out for yourself as this debate rages on.
Majorities In Senate And Public Support Birth Control Coverage
by Julie Rovner and Scott Hensley
- March 1, 2012
The Senate has turned back an attempt to kill President Obama’s new rules requiring most health insurance plans to provide contraceptives without additional cost.
The 51-48 vote against an amendment to an unrelated highway bill (Yes, that’s just how the Senate works) was mostly along party lines.
Missouri Republican Roy Blunt, the amendment’s sponsor said its goal was a simple one. “I believe what this does is protect First Amendment rights. The first freedom in the founding documents is freedom of religion,” he said.
The amendment would have allowed employers to opt out of the mandate to cover birth control. It was the latest in a series of collisions between the right to follow one’s conscience and the demands of society.
Senate Democrats, like New Jersey’s Frank Lautenberg, said the amendment’s language was so vague it would allow employers to deny coverage of any benefit to which they had a religious or moral objection.
“Imagine that your boss is going to decide whether or not you’re acting morally,” he said.
The Obama administration weighed in on the language last night, with Health and Human Services Secretary Kathleen Sebelius calling it, “a cynical attempt to roll back decades of progress in women’s health.”
After the vote, the Coalition to Protect Women’s Health Care, a consortium of women’s health advocates, said in a statement, “We believe, as do the majority of Americans, that health care decisions should be made between doctors and patients, not employers.”
And there are fresh poll data out from the Kaiser Family Foundation that show that’s the case. Overall, 63 percent of Americans support the birth control coverage mandate. But among Republicans that support drops to 42 percent, according to the poll conducted last month. [Copyright 2012 National Public Radio]
Obama birth control compromise distracts from issue of whether the pill is safe, activists say
From THE WASHINGTON POST - NATIONAL - blog POST
After weeks of uproar over a new requirement that religious employers provide free birth control, President Obama said Friday he had found a compromise.
Workers at religious institutions, he said, will get free contraceptiondirectly from health insurance companies instead of their employer. Both sides of the debate welcomed the announcement.
So everybody wins, right?
Everybody except the women taking the pill, some activists say. During the past year, they say, there have been a number of troubling developments concerning birth control, and yet the national discussion remains focused on who is doling it out.
Last month, Pfizer recalled one million packets of birth control pills due to pregnancy concerns, because of a manufacturing mix-up. Several weeks before that, an advisory committee to the FDA said labels on the popular Yaz and Yasmin pills didn’t contain the information they should about possibly causing blood clots. Two different studies found those pills put women at a higher risk of blood clots.
Women began self-reporting health problems like blood clots, too, often on “survivor boards” As of last month, approximately 10,000 lawsuits piled up against Bayer by women who have suffered blood clots or by the families of women who have died while taking Yaz or Yasmin.
And yet the pill continues to see an almost universally positive representation in the media, writes Holly Grigg-Spall in Ms. Magazine, as “a quality of life treatment,” and curer of acne, bloating and anxiety.
I’m surprised there has not been a broader call for more research, or wider public discussions of the risks of this pill. When a drug company is withholding data and 10,000 lawsuits are pending, more than research is needed. I can’t help but wonder why we’re not seeing congressional hearings–akin to the 1970 Nelson Pill Hearings – again, and more of an outcry from both physicians and patients.
Grigg-Spall thinks there is a lack of education because it helps sustain the profits pharmaceuticals companies.
“In this current climate… it is very difficult for women to have an intelligent, critical discussion about their birth control choices and particularly about the relative dominance of hormonal contraceptives,” she wrote in an email to The Post.
Grigg-Spall started a blog called “Sweetening the Pill,” about the dangers of birth control, because she started feeling depressed after switching to a new brand of pill. But these days, she is outraged about all the women she says she has encountered who have faced even worse side effects.
Friday, Obama sought to soothe a different outrage over birth control. “This is not only unacceptable, it is un-American,” Sen. Joe Manchin (D-W.Va.), a Catholic, had said of the requirement that religious employers provide free birth control. “Correct this decision which will erode the conscience rights,” another Catholic senator, Bob Casey of Pennsylvania, had said.
In Friday’s press conference, Obama corrected that decision. It did not escape activists’ notice, however, that he made no mention of the birth control pill’s possible risks.
Ms. MAGAZINE BLOG:
Just How Safe is Yaz? Women Need to Know!
The oral contraceptive Yasmin was released in 2001 by the pharmaceutical company Bayer, followed by Yaz in 2006. They differ from other birth control pills in the synthetic progesterone they utilize, drospirenone, which is marketed as less likely to cause weight gain and bloating than other birth control pills. Yaz soon became the most popular birth control pill in the U.S., due in part to a widespread advertising campaign promoting the drug as what theNew York Times dubbed “a quality of life treatment,” claiming it could also clear up acne, prevent bloating and ease the depression and anxiety associated with both PMS and the controversial condition ofPMDD. It prevents pregnancy at the same rate of effectiveness as all other oral contraceptives.
In 2009, the FDA requested that Bayer distribute a corrective advertisement to counter its aggressively screened commercials that were said to be making misleading assertions about the capabilities of the drug, promoting it for unapproved uses and making light of the more serious health risks (such as blood clots). However, in 2010 the drug remained the second-best-selling Bayer product, bringing in$1.5 billion in sales.
As of January 2012, there are approximately 10,000 lawsuits against Bayer by women who have suffered blood clots and by the families of those women who have died whilst taking Yaz or Yasmin. It is considered the most complained-about drug on the Internet, with thousands of women voicing concerns in online forums and support groups over health issues both physical and emotional. Jane Bennett and Alexandra Pope, authors of The Pill: Are You Sure It’s for You?, characterize many of these problems as “quality-of-life-threatening.” I have written extensively on my own experience with Yasmin in my blog, Sweetening the Pill, and for the UK Independent and have been quoted in Fabulous magazine the Washington Post.
Two studies conducted with funding from Bayer revealed that Yaz and Yasmin held no higher risk of blood clots than other birth control pills. However, last month it was revealed that five other studies undertaken independent of Bayer suggested a 50-to-75 percent increased risk of clots for those taking these birth control pills in comparison to others. A former FDA commissioner, David Kessler, charged that Bayer deliberately withheld data about this early on in order to push through the drugs’ approvals. In response, the FDA called an advisory committee to evaluate the safety of birth control pills containing drospirenone. The decision had the potential to cause the drugs to be pulled off the market, but the panel voted by a four-person margin that the drugs’ benefit outweighed the risks.
Yet a government watchdog group, the Project on Government Oversight (POGO), conducted an independent investigation that revealed three of the advisors on the FDA panel had research or other financial ties to Bayer. A fourth advisor was connected to manufacturing the generic version of these pills. All four voted for Yaz and Yasmin to continue to be prescribed by doctors. POGO asked the FDA that a new advisory committee be brought together to make another assessment.
Should these developments impact women’s perspective on the birth control pill? Should we consider that use of the Pill for pregnancy prevention, let alone acne or PMS, is still today, as women’s health activist Barbara Seaman wrote in her 1969 book The Doctors’ Case Against the Pill, “like tinkering with nuclear bombs to fight off the common cold”?
I’m surprised there has not been a broader call for more research, or wider public discussions of the risks of this pill. When a drug company is withholding data and 10,000 lawsuits are pending, more than research is needed. I can’t help but wonder why we’re not seeing Congressional hearings–akin to the 1970 Nelson Pill Hearings–again, and more of an outcry from both physicians and patients.
Much of the media coverage of these recent developments and research was quick to assert the unimportance of women’s concerns. It was repeatedly reported that, when compared to the risk of blood clot development associated with pregnancy, the risk produced by taking any oral contraceptive–including Yasmin or Yaz–is of little concern. This is misleading in that it suggests there are only two states in which young women can choose to live: on birth control pills or pregnant. The fear has been voiced that any discussion of the negative impact of the Pill will prompt women to come off of it and fall unintentionally pregnant. No coverage that this writer has read discussed a comparison with non-hormonal contraceptive alternatives–which, of course, hold no increased risk of blood clots. Some of these alternatives are just as effective in preventing pregnancy as oral contraceptives, and others are more so.
According to Laura Wershler, veteran pro-choice sexual and reproductive health advocate and board director of theCanadian Federation for Sexual Health,
We need to reframe the idea that hormonal birth control is the gold standard of contraception. If women are quitting the Pill, and they have every right to do so, and they are not using alternative methods of birth control effectively, that’s proof positive that what we are teaching about contraception is incomplete and ineffective. If we make the Pill the ‘right’ choice, then why should we be upset when women stop taking it and get pregnant?
It is often claimed within news stories that the Pill “regulates” a woman’s menstrual cycle, when it, in fact, stops and replaces the cycle. All of this propaganda for the Pill is extremely misleading, and it further breeds a lack of confidence to know that Bayer paid women’s magazines to advocate for Yaz. Such actions blind women to their choices and to understanding how their bodies work. There is much research that supports the health benefits of consistent (typically monthly) ovulation, which can be found through the Centre for Menstrual Cycle and Ovulation Research.
The absence of education in body literacy is a major factor in unwanted pregnancies. However, this lack of education is beneficial to some: It helps sustain the billion-dollar profits of pharmaceutical companies.
Photo is the cover of The Pill: Are You Sure It’s for You?