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. 7, 2012 at 11:32am

DATELINE, “The Hansen Files”: Drug Trials, aired on March 4, 2012 and explored how ‘clinical trials’ that pharmaceutical companies sponsor, or conduct, overseas should raise some ‘red flags’ with the #FDA, consumers and regulators. If you taken any prescription medications on a regular basis, or know anyone that does, this is worth watching. It really makes you wonder about how drugs are approved, regulated and followed in all countries.

Mar. 5, 2012 at 8:18pm
Many baby products not required to meet standards  http://usat.ly/x8chgl

Many baby products not required to meet standards http://usat.ly/x8chgl

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

ABC News explains the PFIZER LO/OVRAL #recall.

(Source: yazrecall.com)

CNN previously explored events leading up to the FDA’s 12.8.11 Advisory Committee and public hearings on the potential health risk posed by #DRSP (#DROSPIRENONE) containing birth control pills: #YASMIN, #YAZ, #BEYAZ, #OCELLA, #GIANVI and other generics.

In a narrow 15-11 vote the experts on the Advisory Committee decided that the pills were sufficiently effective in the prevention of pregnancy to outweigh the confirmed risk of blood clots they presented to users of all ages. Notably, a growing body of scientific evidence has repeatedly found the pills present a higher risk of blood clots. Estimates vary on the significantly higher risk they pose. However, a FDA funded study found that they are 75%-77% higher risk in comparison to other available birth control pills.  The same experts voted that this risk was not adequately presented in current warnings associated with the product. This is significant because the warning labels and inserts had already been revised twice in less than a twenty-four (24) month period. As a result, it is anticipated that the confusing and arguably misleading labels will be revised yet again in coming months.

Sadly, #DRSP (#DROSPIRENONE) containing birth control pills have been available for over a decade in the United States. Recent science confirms that added risk were not communicated, and that scientific research is catching up with the #DRSP (#DROSPIRENONE) family of pills that delivered more risk than was communicated.

Gabriel F. Zambrano, P.A., is the author and sponsor of this post. Gabriel F. Zambrano, P.A., is actively representing girls and women that have suffered catastrophic injuries from blood clots associated with the DRSP (DROSPIRENONE) family of contraceptives. Additional information is available at DRSPRecall

 
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.

Defunct manufacuturer, Poly Implant Prothese (PIP), has left a scandalous legacy as reported by CNN. Nearly 500,000 women worldwide are believed to have received their silicone breast implants that were recalled for unusually high failure rates. Recent news reports indicate the implants contained industrial, non-medical grade, silicone adding to questions over their safety and the risk women face moving forward. At least one news report has questioned whether a link to anaplastic large cell lymphoma (ALCL) is related to a removed PIP silicone breast implant further raising a specter of concern and anxiety for victims.

#NOVARTIS announced a massive #recall of over the counter pills on January 9, 2012. This recall applies to #EXCEDERIN, #BUFFERIN, #NODOZ and #GASX products. Emerging reports indicate that the facility, in Lincoln, Nebraska, where the pills were manufactured and packaged had failed repeated safety inspections by the FDA. Chips of different products were found in the wrong containers, indicative of a failure to ‘clear’ the manufacturing lines or machinery used for packaging. While this recall involves ‘over the counter’ medicines found in many households it should be taken seriously as a stray pill could lead to an allergic reaction or adverse event.

Of additional significance is the fact that, the FDA announced that ENDO PHARMACEUTICAL opiod products - or pain killers - should be carefully evaluated to confirm they are the intended prescription only product intended for consumers. Apparently, the prescription pain killers were also manufactured at the same facility and isolated incidents of confusion were reported, but averted, by pharmacists while filling prescriptions.

Refunds are available from Novartis by visiting the company website and following directions. Adverse events, allergic reactions or illness should be reported to the FDA and health authorities.

Jan. 9, 2012 at 10:11am
#NOVARTIS #recalls popular over the counter: #Excederin, #Bufferin #NoDoz, #GASX. Apparently, problems and mix ups relating to the over the counter meds during the manufacturing process precipitated the #recall. Details are still emerging. FDA is warning about related opiod meds made for ENDO and requesting patients and providers to scrutinize tablets.
http://usat.ly/ygrtMt

#NOVARTIS #recalls popular over the counter: #Excederin, #Bufferin #NoDoz, #GASX. Apparently, problems and mix ups relating to the over the counter meds during the manufacturing process precipitated the #recall. Details are still emerging. FDA is warning about related opiod meds made for ENDO and requesting patients and providers to scrutinize tablets.
http://usat.ly/ygrtMt