Class action $15M lawsuit against birth control makers

April 10, 2010 By Leave a Comment

Here’s an article that just came through my inbox, about a class action lawsuit against the makers of birth control pills.  I have been amazed for some time that young women take birth control pills for acne, and have always wondered if they even tried to eliminate the acne through better diet and exercise.  Hopefully cases like this will get young women to re-think their choices – and their lifestyle – at an early age.

Calgarians join class action $15M lawsuit
against birth control makers

Eight months after Chloe Papparis began taking a birth control pill for acne, she almost died from severe side-effects, she says.

The teen started suffering from a bad migraine headache and frequent bouts of vomiting last August. Her family doctor thought it might be swine flu.

Six days later, however, Papparis was rushed to Foothills Hospital. Doctors told her she was 24 hours from dying.

“When I was in ER, the doctor by fluke said to give me a CT scan. They found five blood clots on my brain,” Papparis, now 18, said Thursday.

“I was told I had had a stroke and I wasn’t supposed to be living. If we had waited . . . I would have died.”

Papparis is among 800 Canadians taking part in class-action lawsuits against the manufacturer of two birth control drugs, Yaz and Yasmin, which they allege have caused severe reactions, including seven deaths.

All of the claims have been filed by Tony Merchant of the Merchant Law Group.

Fifty-four of the 90 Alberta plaintiffs in the $15-million lawsuit are from this city. That suit was filed at the Court of Queen’s Bench in Calgary.

None of their allegations have been proven in court, and the defendants, all subsidiaries of manufacturer Bayer Inc., have yet to file statements of defence.

Merchant said Thursday his firm has filed or is about to file similar multimillion-dollar claims in all provinces except Prince Edward Island.

“The seven deaths are all similar in that they were all young women who were healthy,” Merchant said.

“One woman who died was 28, the rest were 14 to 19 years.”

“Of the 400 who do have problems, many have lost their gall bladder. All of them have continual blood pressure problems or blood clots related to blood pressure effects,” said Merchant.

In the claim, it is alleged the Bayer companies “participated in the common purpose of concealing the adverse effects of Yasmin and Yaz from regulatory authorities, the medical community, the public and class (action) members.”

It also alleges the FDA in the U.S. received more than 50 reports of deaths among users of the two drugs between 2004 and 2008.

“These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child-bearing years,” says the statement of claim.

It alleges the defendants knew or should have known that use of Yaz and Yasmin created an increased risk to consumers of personal serious injury, including but not limited to gallbladder disease, blood clots and strokes.

Papparis, meanwhile, spent six days in hospital and was placed on the anti-coagulant Heparin for six months to prevent clotting.

She is now off the drug but can never take birth control pills again. Doctors will have to be careful with her if she ever goes through surgery, for fear of more blood clotting.

Despina Papparis says her daughter was the first person to be admitted to the stroke clinic at Foothills Hospital because of reactions to Yaz, Yasmin and Ocella — all birth control pills with synthetic estrogen — but there have been several more since then.

“It was scary, it was horrifying, we’ve had nightmares,” she said.

“She started in December (2008), because she was graduating in May. She was taking it to clear up her acne for grad and her grad photos. The doctor handed it over and we didn’t think anything of it.

“We were lucky the doctor ordered the CT scan. He said had I not brought her in, she wouldn’t have survived Saturday. It was sheer luck. Why would I expect blood clots?”

Chloe said she doesn’t want anyone else to suffer.

“What happened to me is the worst thing of my life,” she said. “I don’t want other girls to go through it, too.”

By Daryl Slade, Calgary Herald
April 9, 2010

Filed Under: Birth Control, Blog, Medications Tagged With: , , , , , , , , , , , , , , , ,

Antidepressants are worthless for most of the people for whom they are prescribed

January 8, 2010 By Leave a Comment

THE NEW YORK TIMES
January 6, 2010
Popular Drugs May Help Only Severe Depression
By BENEDICT CAREY

Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday.

The findings could help settle a longstanding debate about antidepressants. While the study does not imply that the drugs are worthless for anyone with moderate to serious depression – many such people do seem to benefit – it does provide one likely explanation for the sharp disagreement among experts about the drugs’ overall effectiveness.

Taken together, previous studies have painted a confusing picture. On one hand, industry-supported trials have generally found that the drugs sharply reduce symptoms. On the other, many studies that were not initially published, or were buried, showed no significant benefits compared with placebos.

The new report, appearing in The Journal of the American Medical Association, reviews data from previous trials on two types of drugs and finds that their effectiveness varies according to the severity of the depression being treated.

Previous analyses had found a similar pattern. But the new study is the first to analyze responses from hundreds of people being treated for more moderate symptoms, as are most people who seek care.

“I think the study could dampen enthusiasm for antidepressant medications a bit, and that may be a good thing,” said Dr. Erick H. Turner, a psychiatrist at Oregon Health and Science University. “People’s expectations for the drugs won’t be so high, and doctors won’t be surprised if they’re not curing every patient they see with medications.”

But Dr. Turner added, “The findings shouldn’t dampen expectations so much that people refuse to even try medication.”

A team of researchers, including psychologists who favor talk therapy and doctors who consult widely with drug makers, performed the new analysis, using government grants. The group evaluated six large drug trials, including 728 men and women, about half of them with severe depression and half with more moderate symptoms.

Three of the trials were of Paxil, from GlaxoSmithKline, a so-called S.S.R.I., and the other three were of imipramine, an older generic drug from the class known as tricyclics. The team, led by Jay C. Fournier and Robert J. DeRubeis of the University of Pennsylvania, found that compared with placebos, the drugs caused a much steeper reduction in symptoms of severe depression (cases scoring 25 or higher on a standard scale of severity, putting them in the top quarter of the sample). Patients with scores of less than 25 got little or no added benefit from the medications.

“We were able to give an overall estimate of effectiveness for the first time in this more moderate severity range, from 14 to 20 on the scale, in which there’s no question that doctors would likely consider prescribing medication,” Dr. DeRubeis said.

His co-authors included Steven D. Hollon and Dr. Richard C. Shelton of Vanderbilt University, Sona Dimidjian of the University of Colorado, Dr. Jan Fawcett of the University of New Mexico and Dr. Jay D. Amsterdam of Penn.

The effects of other popular S.S.R.I.’s like Lexapro and Prozac are not likely to be much different than those of Paxil, experts said.

Dr. DeRubeis and others said antidepressants’ inability to outperform placebos against moderate symptoms stemmed partly from the sustained attention that patients in drug trials received from top doctors – which itself can help relieve symptoms, drug or no drug. For some people, too, the drugs’ side effects may cancel any benefit.

“The message for patients with mild to moderate depression,” Dr. DeRubeis said, “is, ‘Look, medications are always an option, but there’s little evidence that they add to other efforts to shake the depression – whether it’s exercise, seeing the doctor, reading about the disorder or going for psychotherapy.’ “

Filed Under: Blog, Consumer Protection, Medications Tagged With: , , , , , , , , , ,

Hospital’s Oxytocin Protocol Change Sharply Reduces Emergency C-Section Deliveries

June 22, 2009 By Leave a Comment

I’m not much into research studies.  Not one of them has ever convinced me of anything, but I’ll get into the reasons for that another time.  Here’s a hilarious one, though.  Hilarious because it demonstrates how far we’ve gone into needing evidence-based studies to verify for us what should be common sense:

Hospital’s Oxytocin Protocol Change Sharply Reduces Emergency C-Section Deliveries

By Betsy Bates
Elsevier Global Medical News
Conferences in Depth
June 22, 2009

CHICAGO (EGMN) – The modification of the oxytocin infusion protocol at a large university-affiliated community hospital nearly halved the number of emergency cesarean deliveries over a 3-year period, reported Dr. Gary Ventolini.

As oxytocin utilization declined from 93.3% to 78.9%, emergency cesarean deliveries decreased from 10.9% to 5.7%, Dr. Ventolini said at the annual meeting of the American College of Obstetricians and Gynecologists.

Other birth outcomes improved as well at an 848-bed community hospital that serves as the primary teaching hospital of the Boonshoft School of Medicine at Wright State University in Dayton, Ohio.

These included significant declines in emergency vacuum and forceps deliveries and a sharp reduction in neonatal ICU team mobilization for signs of fetal distress (P = .0001 in year 3 compared with year 1).

“More and more data are showing us that we are using too much oxytocin too often,” Dr. Ventolini, professor and chair of obstetrics and gynecology at the university, said in an interview.
“Our pivotal change was to modify the oxytocin infusion from 2 by 2 units every 20 minutes to 1 by 1 unit every 30 minutes. And we see the results,” he said.

Outcomes of 14,184 births from 2005, 2006, and 2007 were retrospectively analyzed to determine any impact of the change in an oxytocin protocol implemented in 2005. Patient characteristics were similar in all three calendar years.

The most profound changes were in emergency deliveries, including caesarean deliveries, vacuum deliveries (which dropped from 9.1% to 8.5%), and forceps deliveries (which fell from 4% to 2.3%).

The overall cesarean section rate remained unchanged, as did the rates of cord prolapse, preeclampsia, and abruption.

Dr. Ventolini cited a recent article in the American Journal of Obstetrics and Gynecology that suggests guidelines for oxytocin use, including avoidance of dose increases at intervals shorter than 30 minutes in most situations (Am. J. Obstet. Gynecol. 2009;200:35.e1-.e6).

Dr. Ventolini and his associates reported no financial conflicts of interest relevant to the study.

Here is the actual link to the story: http://egmn.idsk.com/stories_global/35_ds_7863805.jsp

Filed Under: Blog, Childbirth, Consumer Protection, Legal, Medications Tagged With: , , , , , , , , , , ,

Drugs, Drugs and More Drugs

April 14, 2008 By Leave a Comment

I was just sent a long, but interesting YouTube video on the dangers of pharmaceutical drugs, vaccinations, and more.  Had I done it, I would have included my references (and added a little something about childbirth) - but this still worth watching.    Click here: YouTube – Why I Left Mainstream Medicine – From A Nurse

I would welcome emails and/or comments below on your thoughts, critiques and/or verification of the claims made on this video.   Note that Tedd Koren covers the dangers of vaccinations in detail in his Childhood Vaccination series (only one more run, in June/July), and Jim Turner of Conscious Activism is a tremendous source of information regarding artificial sweeteners.  Also, Sarah Buckley describes the impact of pitocin, epidurals and cesareans on mother and baby in her Gentle Birth: The Science and the Wisdom series.

Filed Under: Blog, Childbirth, Consumer Protection, Medications, Vaccinations Tagged With: , , , , , , , , , ,

Cytotec and Other Verdicts

April 11, 2008 By 1 Comment

The comments and follow-up to the Maddy Oden Conscious Woman of the Month article are still coming in.  Gloria Lemay just sent me a reference to an older case involving cytotec and failure to obtain informed consent – this one with a large verdict. Maddy has informed me that there is also a cytotec lawyers site – she is not sure how successful they are in gathering and winning cases, but some are won. Apparently most are settled out of court with gag clauses.

$2 million
Failure To Obtain Consent For Off-Label Use Of Cytotec
Case name withheld.
Plaintiff’s Counsel: Joseph J. Wadland and James L. Ackerman, Wadland & Ackerman, Boston and Andover
The plaintiffs were a 38-year-old woman and her husband who were expecting their first child. At about 41 weeks of gestation, the decision was made by her primary Ob/Gyn to induce her labor. A dose of 25 micrograms of Cytotec, a drug that the FDA has approved for the prevention of gastric ulcers, but not for the induction of labor or cervical ripening, reportedly was given vaginally. The care providers did not obtain the mother’s informed consent for the use of Cytotec that was being administered for an “off-label” indication in a high-risk situation. A series of complications arose, including the deceleration of the fetal heart rate and the baby was delivered via Caesarian section. The baby was lifeless and resuscitation efforts were unsuccessful. The mother also required a hysterectomy as a result of off-label use of Cytotec. When the claim settled on Aug. 7, 2001, it was the first reported settlement or verdict in Massachusetts involving the drug Cytotec.  And a few more maternity related lawsuits among the largest settlements in MA in 2001: http://www.masslaw.com/reprints/breakstone011402.htm 
 

Although the facts of this case are horrific, it is encouraging to see this as nearly all verdicts against OB/GYNs are for failing to do a cesarean or failing to do one soon enough.  These kinds of verdicts play a major role the rise in the cesarean rate – for every woman who sues for those reasons, hundreds of others are cut unnecessarily, causing unnecessary trauma and increased risk to the mothers and their babies.  Defensive medicine at its worst. 

Furthermore – and worthy of similar attention and concern – new obstetricians are no longer taught the skills necessary to handle out-of-the-ordinary vaginal births.  If your birth doesn’t go like clockwork, you’re off to the OR.  If your baby isn’t in a good position, you’re off to the OR.  Breech? Forget it – directly into the OR. Vaginal breech birth is no longer part of the curriculum. I could go on and on — and I know there are exceptions, but they are becoming increasingly rare.

More widespread publicity of cases such as the following is essential – the public needs to know about the dangers of these drugs, among others and of the risks inherent in many obstetric practices.    And that babies don’t all come out “on time” and in the same presentation.

Filed Under: Blog, Childbirth, Consumer Protection, Legal, Medications Tagged With: , , , , , , , , ,