Yaz Panel Was Filled With ‘Irregularities’: Advocates

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.]”

http://www.pharmalot.com/2012/03/yaz-panel-was-filled-with-irregularities-advocates/

Mar. 9, 2012 at 12:38pm
Birth control prices range widley from $100 to $1,000
http://usat.ly/xxdbC5
However, you better ask about increased risks or side effects because you have to look out for yourself as this debate rages on.

Birth control prices range widley from $100 to $1,000
http://usat.ly/xxdbC5
However, you better ask about increased risks or side effects because you have to look out for yourself as this debate rages on.

Mar. 5, 2012 at 9:01pm
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]

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
By Elizabeth Flock


After weeks of uproar over a new requirement that religious employers provide free birth control, President Obama said Friday he had found a compromise.
Norgestrel and Ethinyl Estradiol birth control tablets. (Reuters)
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.
Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research, wrote recently:

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.








By	Elizabeth Flock  |  04:33 PM ET, 02/10/2012 Tags:  National, Obama, birth control, the pill

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.


Norgestrel and Ethinyl Estradiol birth control tablets. (Reuters)

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.

Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research, wrote recently:

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.

By   |  04:33 PM ET, 02/10/2012 

Tags:  NationalObamabirth controlthe pill

 
Ms. MAGAZINE BLOG:
Just How Safe is Yaz? Women Need to Know!

February 9, 2012 by Holly Grigg-Spall · Leave a Comment 


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”?
Says Ms. blogger Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research:

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?
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Ms. MAGAZINE BLOG:

Just How Safe is Yaz? Women Need to Know!

February 9, 2012 by  · Leave a Comment 

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”?

Says Ms. blogger Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research:

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?

 


FERTILITY
Pfizer Birth Control Recall: Could Women Who Get Pregnant Sue?
If women wind up pregnant from faulty pill packets, product liability lawsuits or “wrongful pregnancy” cases — reminiscent of medical malpractice — could be filed.
By BONNIE ROCHMAN | @brochman | February 3, 2012 | 








PETER DAZELEY / PHOTOGRAPHER’S CHOICE / GETTY IMAGES


It didn’t take long for the speculation to start: if women unintentionally get pregnant while taking the defective birth control pills that Pfizer recalled this week, could they, would they, sue?
Earlier this week, Pfizer recalled 1 million packages of pills — 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets — after uncovering a packaging error that included too many active tablets in some packets and not enough in others. It cautioned women to use alternate contraceptive methods because they were at greater risk of becoming pregnant. In a statement, the company said that the recalled pills don’t pose “any immediate health risks.” That, of course, depends completely upon how you define “health risks.” Assuming you’re taking the pills to avoid having a baby but end up faced with what to do about an unwanted pregnancy, the ensuing stress could arguably count as a mental health risk, at the least. An unanticipated pregnancy is certainly more than just a minor inconvenience.
MORE: Why Abortion Is Less Risky than Childbirth
For most women, it’s likely too early to know if the packaging defect has resulted in unintended pregnancy. But already, bloggers have begun running scenarios.
LawInfo wondered whether product liability lawsuits — which “generally involve a product that was designed defectively or gave an insufficient warning to the consumer who was eventually harmed as a result of the design or warning defect” — might bubble up.
(Video: Nancy Gibbs on the Pill’s Importance)
This would not be the first example of a “wrongful pregnancy” case, according to I. Glenn Cohen, assistant professor and co-director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, who spoke with MyHealthNewsDaily:

Similar cases have allowed people to sue for things like unwanted pregnancies after botched vasectomies. In the past, there has even been a case in which a woman successfully sued a pharmacist for a pregnancy that resulted from errors in filling the woman’s birth control prescriptions, Cohen said.
The best chance for a case, however, would be for affected women with unwanted pregnancies to band together and bring a class-action lawsuit against Pfizer, said Arthur Caplan, a bioethicist at the University of Pennsylvania. Such a case could ask for considerably more money than an individual case, and would be more attractive to lawyers, Caplan said.
“I’m sure some enterprising lawyer is already thinking of bringing a class-action lawsuit…against the company,” Cohen said.

It’s unlikely that any settlement would approach the cost of raising a child, which, at $226,920, may in itself be a fairly effective method of birth control.
MORE: ‘The Pregnancy Project’: Why One Girl Decided to Fake Her Baby Bump
SPECIALS: The Pill That Unleashed Sex
MAGAZINE: The Pill at 50: Sex, Freedom and Paradox
Bonnie Rochman is a reporter at TIME. Find her on Twitter at @brochman. You can also continue the discussion on TIME‘s Facebook page and on Twitter at @TIME.

Read more: http://healthland.time.com/2012/02/03/pfizer-recall-could-women-who-get-pregnant-from-recalled-birth-control-pills-sue/#ixzz1lpOuAGes

Pfizer Birth Control Recall: Could Women Who Get Pregnant Sue?

If women wind up pregnant from faulty pill packets, product liability lawsuits or “wrongful pregnancy” cases — reminiscent of medical malpractice — could be filed.
Peter Dazeley / Photographer's Choice / Getty Images
PETER DAZELEY / PHOTOGRAPHER’S CHOICE / GETTY IMAGES

It didn’t take long for the speculation to start: if women unintentionally get pregnant while taking the defective birth control pills that Pfizer recalled this week, could they, would they, sue?

Earlier this week, Pfizer recalled 1 million packages of pills — 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets — after uncovering a packaging error that included too many active tablets in some packets and not enough in others. It cautioned women to use alternate contraceptive methods because they were at greater risk of becoming pregnant. In a statement, the company said that the recalled pills don’t pose “any immediate health risks.” That, of course, depends completely upon how you define “health risks.” Assuming you’re taking the pills to avoid having a baby but end up faced with what to do about an unwanted pregnancy, the ensuing stress could arguably count as a mental health risk, at the least. An unanticipated pregnancy is certainly more than just a minor inconvenience.

MORE: Why Abortion Is Less Risky than Childbirth

For most women, it’s likely too early to know if the packaging defect has resulted in unintended pregnancy. But already, bloggers have begun running scenarios.

LawInfo wondered whether product liability lawsuits — which “generally involve a product that was designed defectively or gave an insufficient warning to the consumer who was eventually harmed as a result of the design or warning defect” — might bubble up.

(Video: Nancy Gibbs on the Pill’s Importance)

This would not be the first example of a “wrongful pregnancy” case, according to I. Glenn Cohen, assistant professor and co-director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, who spoke with MyHealthNewsDaily:

Similar cases have allowed people to sue for things like unwanted pregnancies after botched vasectomies. In the past, there has even been a case in which a woman successfully sued a pharmacist for a pregnancy that resulted from errors in filling the woman’s birth control prescriptions, Cohen said.

The best chance for a case, however, would be for affected women with unwanted pregnancies to band together and bring a class-action lawsuit against Pfizer, said Arthur Caplan, a bioethicist at the University of Pennsylvania. Such a case could ask for considerably more money than an individual case, and would be more attractive to lawyers, Caplan said.

“I’m sure some enterprising lawyer is already thinking of bringing a class-action lawsuit…against the company,” Cohen said.

It’s unlikely that any settlement would approach the cost of raising a child, which, at $226,920, may in itself be a fairly effective method of birth control.

MORE: ‘The Pregnancy Project’: Why One Girl Decided to Fake Her Baby Bump

SPECIALS: The Pill That Unleashed Sex

MAGAZINE: The Pill at 50: Sex, Freedom and Paradox

Bonnie Rochman is a reporter at TIME. Find her on Twitter at @brochman. You can also continue the discussion on TIME‘s Facebook page and on Twitter at @TIME.



Read more: http://healthland.time.com/2012/02/03/pfizer-recall-could-women-who-get-pregnant-from-recalled-birth-control-pills-sue/#ixzz1lpOuAGes

 
Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.
It began suddenly a little over 10 years ago. With impressive fluency, friends, family members and patients started asking me about random medications, the odd syncopations of those invented, polysyllabic pharmaceutical brand names – Viagra, Lipitor — rolling perfectly off their tongues.
The questions they asked about those drugs did not reflect breaking news or the results of scientific studies. Rather, they were a reflection of sound bites, advertisements and the draw of celebrities who endorsed them, all part of carefully conceived marketing schemes.
There’s no question that Americans like their prescription medications. We spend nearly twice as much per person on pharmaceuticals as patients in other developed countries do, and we account for nearly half of all sales worldwide. But in 1997, when the Food and Drug Administration loosened its regulations and the United States became one of only four countries to allow direct-to-consumer advertising (the others are New Zealand, Bangladesh and South Korea), we entered a new era in pharmaceutical consumerism.
Players in the drug industry began aiming their advertisements at patients, and their goal was to define in the minds of patients not only the beneficial effects of the drugs but also the diseases they were designed to treat.
As Vince Parry, a well-known marketing expert, counseled his colleagues, “If you can define a particular condition and its associated symptoms in the minds of physicians and patients, you can also predicate the best treatment for that condition.”
The phenomenon is sometimes referred to as “disease mongering,” redefining what is normal and abnormal in a way that widens potential markets for those who sell treatments. And, as detailed in a recent study in the journal Social Science & Medicine, one marketing strategy has accomplished more in this regard than any other by using what has come to be the very symbol of quality and reliability for doctors and patients everywhere: the checklist. 
Placed on Web sites, on downloadable apps and in pamphlets in doctors’ offices, these checklists of symptoms have become a critical part of every major pharmaceutical marketing campaign. What makes them so attractive is that they make it easy for patients to diagnose their own ailments, to take some control over their own health.
What makes the checklists so powerful is their ability to influence patient preferences.
The makers of Yaz, a birth control pill, for example, used a checklist to help promote the use of their drug as a treatment for premenstrual dysphoric disorder, a controversial diagnosis said to affect up to 10 percent of women. Alongside links to articles on fashion, makeup, hair and celebrity news, Yaz’s Web site offered a “Body Diary” checklist to help patients determine whether they suffer from the disorder.
Taking its cues from the Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., which mental health professionals use to diagnose disease, the checklist offered watered-down and potentially more inclusive descriptions. A symptom described in the D.S.M. as “persistent and marked anger or irritability or increased interpersonal conflicts” appeared in the Yaz questionnaire as “Felt angry, or irritable.” “Marked change in appetite, overeating, or specific food cravings” became “Had increased appetite or overate; or had cravings for specific foods.” The printable results that patients could then take to their doctors (the site has since been taken down) were on a form emblazoned with the birth control brand.
“The whole point of tools like this one is to confine people’s experiences into these categories in order to make a diagnosis in line with the branded drug,” said the author of the study, Mary Ebeling, an assistant professor of sociology at Drexel University in Philadelphia who got interested in the use of checklists while doing research at a marketing firm. “I became really intrigued when I saw a group of marketers sitting around a table in Midtown Manhattan and coming up with symptoms.”
Some symptom checklists are clearly branded, so patients and clinicians can easily discern the pharmaceutical interests involved. But many are less obvious or are used as part of advocacy groups’ materials or awareness events. For example, National Depression Screening Day, held annually at college campuses, military sites and community centers across the country, uses a symptom checklist called the Patient Health Questionnaire, or PHQ-9. The nine questions are based on a well-known anxiety screening tool, but its copyright is held by Pfizer, maker of the antidepressant Zoloft.
It’s difficult to ascertain whether efforts aimed directly at consumers ultimately translate into real sales. A recent marketing study found that fewer than 3 percent of patients mentioned a marketed drug by name and less than 1 percent asked for a prescription. However, a separate study comparing patients in Canada, where direct-to-consumer marketing is illegal, with those in the United States found that American patients were more than twice as likely to request advertised medications.
But sales may not be the only measure of success for these campaigns. “The whole point of this marketing and branding is that the name ends up in the minds of the consumers,” Dr. Ebeling said.
While the Obama administration is looking to force pharmaceutical companies to disclose any payments to doctors that might influence their treatment decision, marketing efforts directed at patients are likely to continue to grow. And with those efforts comes a widening, not shrinking, circle of interests that can influence their care.
“There are pharmaceutical marketers, medical device makers, health insurers and whoever is involved in the health industry sitting in the exam room, not just the doctor and patient,” Dr. Ebeling said.
She added, “I find that disturbing, because it’s our health and the quality of our lives that are at stake.”
Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.
Correction: An earlier version of this article incorrectly listed Pakistan as one of four countries that allow direct-to-consumer advertising of pharmaceuticals. The four countries are the United States, New Zealand, South Korea and Bangladesh, not Pakistan.

Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.

It began suddenly a little over 10 years ago. With impressive fluency, friends, family members and patients started asking me about random medications, the odd syncopations of those invented, polysyllabic pharmaceutical brand names – Viagra, Lipitor — rolling perfectly off their tongues.

The questions they asked about those drugs did not reflect breaking news or the results of scientific studies. Rather, they were a reflection of sound bites, advertisements and the draw of celebrities who endorsed them, all part of carefully conceived marketing schemes.

There’s no question that Americans like their prescription medications. We spend nearly twice as much per person on pharmaceuticals as patients in other developed countries do, and we account for nearly half of all sales worldwide. But in 1997, when the Food and Drug Administration loosened its regulations and the United States became one of only four countries to allow direct-to-consumer advertising (the others are New Zealand, Bangladesh and South Korea), we entered a new era in pharmaceutical consumerism.

Players in the drug industry began aiming their advertisements at patients, and their goal was to define in the minds of patients not only the beneficial effects of the drugs but also the diseases they were designed to treat.

As Vince Parry, a well-known marketing expert, counseled his colleagues, “If you can define a particular condition and its associated symptoms in the minds of physicians and patients, you can also predicate the best treatment for that condition.”

The phenomenon is sometimes referred to as “disease mongering,” redefining what is normal and abnormal in a way that widens potential markets for those who sell treatments. And, as detailed in a recent study in the journal Social Science & Medicine, one marketing strategy has accomplished more in this regard than any other by using what has come to be the very symbol of quality and reliability for doctors and patients everywhere: the checklist. 

Placed on Web sites, on downloadable apps and in pamphlets in doctors’ offices, these checklists of symptoms have become a critical part of every major pharmaceutical marketing campaign. What makes them so attractive is that they make it easy for patients to diagnose their own ailments, to take some control over their own health.

What makes the checklists so powerful is their ability to influence patient preferences.

The makers of Yaz, a birth control pill, for example, used a checklist to help promote the use of their drug as a treatment for premenstrual dysphoric disorder, a controversial diagnosis said to affect up to 10 percent of women. Alongside links to articles on fashion, makeup, hair and celebrity news, Yaz’s Web site offered a “Body Diary” checklist to help patients determine whether they suffer from the disorder.

Taking its cues from the Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., which mental health professionals use to diagnose disease, the checklist offered watered-down and potentially more inclusive descriptions. A symptom described in the D.S.M. as “persistent and marked anger or irritability or increased interpersonal conflicts” appeared in the Yaz questionnaire as “Felt angry, or irritable.” “Marked change in appetite, overeating, or specific food cravings” became “Had increased appetite or overate; or had cravings for specific foods.” The printable results that patients could then take to their doctors (the site has since been taken down) were on a form emblazoned with the birth control brand.

“The whole point of tools like this one is to confine people’s experiences into these categories in order to make a diagnosis in line with the branded drug,” said the author of the study, Mary Ebeling, an assistant professor of sociology at Drexel University in Philadelphia who got interested in the use of checklists while doing research at a marketing firm. “I became really intrigued when I saw a group of marketers sitting around a table in Midtown Manhattan and coming up with symptoms.”

Some symptom checklists are clearly branded, so patients and clinicians can easily discern the pharmaceutical interests involved. But many are less obvious or are used as part of advocacy groups’ materials or awareness events. For example, National Depression Screening Day, held annually at college campuses, military sites and community centers across the country, uses a symptom checklist called the Patient Health Questionnaire, or PHQ-9. The nine questions are based on a well-known anxiety screening tool, but its copyright is held by Pfizer, maker of the antidepressant Zoloft.

It’s difficult to ascertain whether efforts aimed directly at consumers ultimately translate into real sales. A recent marketing study found that fewer than 3 percent of patients mentioned a marketed drug by name and less than 1 percent asked for a prescription. However, a separate study comparing patients in Canada, where direct-to-consumer marketing is illegal, with those in the United States found that American patients were more than twice as likely to request advertised medications.

But sales may not be the only measure of success for these campaigns. “The whole point of this marketing and branding is that the name ends up in the minds of the consumers,” Dr. Ebeling said.

While the Obama administration is looking to force pharmaceutical companies to disclose any payments to doctors that might influence their treatment decision, marketing efforts directed at patients are likely to continue to grow. And with those efforts comes a widening, not shrinking, circle of interests that can influence their care.

“There are pharmaceutical marketers, medical device makers, health insurers and whoever is involved in the health industry sitting in the exam room, not just the doctor and patient,” Dr. Ebeling said.

She added, “I find that disturbing, because it’s our health and the quality of our lives that are at stake.”

Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.


Correction: An earlier version of this article incorrectly listed Pakistan as one of four countries that allow direct-to-consumer advertising of pharmaceuticals. The four countries are the United States, New Zealand, South Korea and Bangladesh, not Pakistan.

FDA required corrective ads, or ‘clear up’, following FDA WARNING LETTERS involving DRSP (DROSPIRENONE) pills and their direct to consumer promotion.

(Source: youtu.be)

FDA Revisits Safety of #DRSP #DROSPIRENONE Birth Control Drugs YAZ, YASMIN, BEYAZ & SAFYRAL - ABC News

12.8.11 FDA Advisory Committee hearings underway today to discuss elevated blood clot risk, side effects and other information pertaining to #DROSPIRENONE #DRSP containing birth control pills. Visit prior posts for more info.

Concerns about an elevated risk of blood clots linked to certain birth-control pills will be discussed early next month by a Food and Drug Administration committee, which could recommend stronger warnings about potentially life-threatening problems.

At issue is the ingredient drospirenone, a form of progestin used in newer pills such as Yaz, Yasmin, Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi and Loryna.

In an effort to resolve conflicting results from previous research, an FDA-led study looked at 835,826 women and found a 74 percent higher incidence of clots for those who took the newer pills compared with those who took older types.

The risk of developing blood clots for all women who take birth-control pills is small overall: about 6 in 10,000, according to the FDA. The additional risk associated with the newer pills would put the number at about 10 in 10,000.

The analysis also found an elevated risk of heart attack and stroke for new users of the newer pills and an increased risk of clots in the legs or lung for women using a vaginal ring or birth-control patch.

On Dec. 8, the FDA committee will review the details of that study, after which they could recommend labeling changes.

The main concern is deep-vein thrombosis (a blood clot, usually in the lower leg or thigh) that breaks loose and leads to a pulmonary embolism, the potentially fatal blockage of an artery in the lung. Symptoms include persistent leg pain, severe chest pain and sudden shortness of breath.

Blood clots also can break loose and lead to strokes and heart attacks.

Emily Neffenger of Sunbury was looking forward to her June wedding when, two months before, she found herself in the bathroom in the middle of the night, unable to speak or open the door.

“The left half of my body was completely numb,” she said. “I sat down and didn’t know what to do. I couldn’t get out of the bathroom and I couldn’t talk. I was just kind of making noises.”

Alex, who is now her husband, found her there and called paramedics. Neffenger, 27, had had a mild stroke.

Eventually, doctors determined that Neffenger has a disorder that makes her prone to blood clots. But she also had been on Yaz, or a generic form, for several years.

Neffenger said doctors should be careful when prescribing birth-control pills and go over all the potential risks. She’d like to see routine testing for clotting problems.

Although blood tests are unlikely to become the norm, doctors can and should be careful to ask women about a family history of clotting and talk about other things that put women at higher risk, including smoking and obesity, said Dr. Geoffrey Eubank, a neurologist and director of Riverside Methodist Hospital’s stroke program.

In addition to learning about the risks associated with birth-control pills in general, women who have a known risk of clotting should have serious discussions with their doctors, he said.

“I think, like every decision, you kind of have to weigh the reasons you are using them against the risk,” he said.

Dr. Lisa Keder, associate professor of obstetrics and gynecology at Ohio State University Medical Center, said she has not been recommending against Yaz and similar pills because studies have shown mixed results and the risks overall are relatively low.

“If you double a rare thing, it’s still a rare thing,” she said.

And it’s important to remember that pregnancy carries an elevated risk of blood clots — about 30 incidents per 10,000 pregnant women — as well, she said.

Women who are concerned about their pills should not stop taking them without talking to their doctors, Keder said. Unintended pregnancy is a serious consideration when women who do not wish to have babies stop their birth control.

Women also should have educated discussions with their doctors about the best pill for them, Keder said. In general, she doesn’t think that Yaz and similar pills have an advantage over older pills.

Bayer, the maker of Yaz, has said that company leaders believe the clotting risks are similar to those associated with other birth-control pills and are working closely with the FDA to evaluate its study.

Full Story at Columbus Dispatch:
http://www.dispatch.com/content/stories/local/2011/11/26/safety-of-birth-control-pills-under-review.html

Concerns about an elevated risk of blood clots linked to certain birth-control pills will be discussed early next month by a Food and Drug Administration committee, which could recommend stronger warnings about potentially life-threatening problems.

At issue is the ingredient drospirenone, a form of progestin used in newer pills such as Yaz, Yasmin, Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi and Loryna.

In an effort to resolve conflicting results from previous research, an FDA-led study looked at 835,826 women and found a 74 percent higher incidence of clots for those who took the newer pills compared with those who took older types.

The risk of developing blood clots for all women who take birth-control pills is small overall: about 6 in 10,000, according to the FDA. The additional risk associated with the newer pills would put the number at about 10 in 10,000.

The analysis also found an elevated risk of heart attack and stroke for new users of the newer pills and an increased risk of clots in the legs or lung for women using a vaginal ring or birth-control patch.

On Dec. 8, the FDA committee will review the details of that study, after which they could recommend labeling changes.

The main concern is deep-vein thrombosis (a blood clot, usually in the lower leg or thigh) that breaks loose and leads to a pulmonary embolism, the potentially fatal blockage of an artery in the lung. Symptoms include persistent leg pain, severe chest pain and sudden shortness of breath.

Blood clots also can break loose and lead to strokes and heart attacks.

Emily Neffenger of Sunbury was looking forward to her June wedding when, two months before, she found herself in the bathroom in the middle of the night, unable to speak or open the door.

“The left half of my body was completely numb,” she said. “I sat down and didn’t know what to do. I couldn’t get out of the bathroom and I couldn’t talk. I was just kind of making noises.”

Alex, who is now her husband, found her there and called paramedics. Neffenger, 27, had had a mild stroke.

Eventually, doctors determined that Neffenger has a disorder that makes her prone to blood clots. But she also had been on Yaz, or a generic form, for several years.

Neffenger said doctors should be careful when prescribing birth-control pills and go over all the potential risks. She’d like to see routine testing for clotting problems.

Although blood tests are unlikely to become the norm, doctors can and should be careful to ask women about a family history of clotting and talk about other things that put women at higher risk, including smoking and obesity, said Dr. Geoffrey Eubank, a neurologist and director of Riverside Methodist Hospital’s stroke program.

In addition to learning about the risks associated with birth-control pills in general, women who have a known risk of clotting should have serious discussions with their doctors, he said.

“I think, like every decision, you kind of have to weigh the reasons you are using them against the risk,” he said.

Dr. Lisa Keder, associate professor of obstetrics and gynecology at Ohio State University Medical Center, said she has not been recommending against Yaz and similar pills because studies have shown mixed results and the risks overall are relatively low.

“If you double a rare thing, it’s still a rare thing,” she said.

And it’s important to remember that pregnancy carries an elevated risk of blood clots — about 30 incidents per 10,000 pregnant women — as well, she said.

Women who are concerned about their pills should not stop taking them without talking to their doctors, Keder said. Unintended pregnancy is a serious consideration when women who do not wish to have babies stop their birth control.

Women also should have educated discussions with their doctors about the best pill for them, Keder said. In general, she doesn’t think that Yaz and similar pills have an advantage over older pills.

Bayer, the maker of Yaz, has said that company leaders believe the clotting risks are similar to those associated with other birth-control pills and are working closely with the FDA to evaluate its study.

Full Story at Columbus Dispatch:
http://www.dispatch.com/content/stories/local/2011/11/26/safety-of-birth-control-pills-under-review.html