Posts Tagged ‘ Yasmin ’

Did Yasmin Clinical Trials Lack Female Researchers?

December 27th, 2009. By janem

yas Did Yasmin Clinical Trials Lack Female Researchers? Historically, clinical trials have studied more males than females, and researchers–for several reasons–test mostly or exclusively men. The Yasmin manufacturer says the effectiveness and safety of Yasmin was established in large-scale clinical trials: it involved 2,629 women. This number may seem substantial, but Viagra was given to over 3,000 men (of course) during its clinical trials and the statin Lipitor (prescribed for both sexes) involved 16,066 patients!

Biomedical scientists and researchers have preferred studying male subjects for a number of reasons including:

The outdated belief that women were just little men and that the only difference was in reproductive organs;
Perceived costs and complexity of recruitment and inclusion of women in clinical trials;
The desire both to protect a woman’s potential fetus (regardless of whether she is pregnant, uses contraceptives, or intendsto conceive) and to avoid legal liability from prenatal exposure.
The potentially confounding effects of women’s hormonal changes.

Clearly, a drug that is taken daily by millions of women-such as Yasmin and Yaz-needs more exhaustive clinical trials. Perhaps the (predominantly male) researchers are biased: they won’t ever take a birth control pill but they might use Viagra or a cholesterol-lowering drug like Lipitor or Crestor, the most widely prescribed medications in the world.

In the recently published book The Push to Prescribe, the authors make it clear that the under-representation–or even complete lack–of women in pharmaceutical research is one reason why women should research a drug such as Yasmin beforehand, even though they trust their doctors.

“Women are at the brunt of bad prescribing practices,” says Alan Cassels, a drug policy researcher. “Historically, it goes back to the birth control pill…Women are the leading consumers of health products, not just for themselves but for their husbands and kids as well.”

The Push to Prescribe also points out that adverse reactions to drugs are a major issue of particular interest to women. The number of people exposed to drugs is much more once it has been approved, meaning that experiences other than those observed in clinical trials are likely to occur after a drug is on the market.

Tags: Yasmin, yasmin clinical trials, Yaz
Posted in Drugs/Medical | 2262No Comments »2009-12-27+19%3A47%3A10janem

Yaz, Yasmin, Gardasil: Are Young Women Just Guinea Pigs?

October 27th, 2009. By LucyC

guineapig 262x300 Yaz, Yasmin, Gardasil: Are Young Women Just Guinea Pigs? A couple of interesting news releases came across my desk this morning: the first is about two new lawsuits filed against Bayer AG alleging the company’s birth control pills Yaz and Yasmin have caused two young women life-threatening health events. The second is about the Gardasil vaccine—more on that in a minute.

First the Yaz lawsuits. Short version: Judith M. Woodall and Tasha Marcell allege that they sustained “severe and permanent personal injuries, pain, suffering, and emotional distress as a result of their use of Yaz.”

To be specific, the news release states: “Ms. Woodall, a resident of Tennessee, first began using Yaz in approximately November 2008. That same month, she suffered a saddle pulmonary embolus and deep vein thrombosis. Ms. Marcell, a resident of Georgia, began taking Yaz in October 2007. She also suffered a pulmonary embolism and deep vein thrombosis shortly after she began using the medication.” Hold that thought.

Now the Gardasil press release. One of the researchers involved in the development of the HPV vaccine spoke at a medical conference earlier this month, and instead of towing the company line—in this case the company is Merck—she is reported to have said “70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, Read the rest of this entry »

Tags: Gardasil, Yasmin, Yaz
Posted in Drugs/Medical | 1671No Comments »2009-10-27+16%3A05%3A26LucyC

Yasmin and Yaz Investors File Lawsuit

October 13th, 2009. By janem

Not only is Bayer likely going to shell out millions of dollars in lawsuits filed by Yasmin and Yaz victims, now its investors are bailing.

It’s bad enough that anyone could suffer serious side effects from Yasmin or Yaz, a drug they thought was harmless, a drug used by thousands and thousands of women to prevent pregnancy. Imagine how furious you would be, knowing that so many women have suffered from this birth control pill, and that you bought into it?

yaz Yasmin and Yaz Investors File Lawsuit

On October 13, yet another lawsuit was filed against Bayer, the maker of Yasmin and Yaz, claiming the company concealed Yasmin and Yaz side effects to boost sales. Bayer has been accused of misleading investors-in this case, two pension funds for firefighters and city employees in Pennsylvania–about the value of the company by concealing the drug’s increased risks of blood clots, strokes, heart attacks, gallbladder disease, pulmonary embolisms and deep vein thrombosis (DVT). By hiding the risks of side effects, the company allegedly defrauded investors by falsely estimating the value of the pharmaceutical company and its birth control products.

According to a report by Bloomberg News, there are currently at least 300 Yaz lawsuits or Yasmin lawsuits pending in state or federal courts throughout the US; at least 200 lawsuits over Yaz or Yasmin are consolidated in a federal MDL that is centralized in the Southern District of Illinois; and another 50 cases are consolidated in Pennsylvania state court in Philadelphia.

Tags: Yasmin, Yasmin lawsuit, Yaz
Posted in Drugs/Medical | 15622 Comments »Yasmin+and+Yaz+Investors+File+Lawsuit2009-10-13+22%3A13%3A17janem

A Fair and Just Legal System Also Needs Moderation

October 9th, 2009. By Hunter West

coffeecuphot A Fair and Just Legal System Also Needs Moderation Important as it is for citizens to have legal recourse to sue in order to right a wrong, do you sometimes wonder if things are getting a bit out of hand?

Case in point: in 2002 a detective with the New York Police Department (NYPD) accidentally shot himself in the knees while sitting on a chair and trying to holster his revolver. The following year he retired on a three-quarters disability pension and is now employed as a court officer in South Carolina making $24,000 annually.

He also sued the City of New York and last November was awarded $4.5 million in damages by a jury.

For accidentally shooting himself in the knee. For that kind money maybe we should all do that.

Obviously, the former NYPD man found himself a talented lawyer who presumably argued that the revolver, issued by the department, was faulty. As the NYPD is an agent of the City, the Big Apple would be on the hook.

Keep in mind that if we are injured, or victimized in concert with a situation or event through no fault of our own, we should have the right to seek compensation.

Case in point: the scores of women who have unknowingly put themselves in harm’s way by simply subscribing to Yaz birth control. They believed Yaz (and Yasmin) to be a safe and effective oral contraceptive, only to find out the hard way about risks for life-threatening blood clots and thrombosis. Women—painfully young, healthy women—have died.

And then there are the thousands of California workers who are robbed of their right to claim, Read the rest of this entry »

Tags: California Overtime, lawsuits, New York, Yasmin, Yaz
Posted in Court of Public Opinion | 1552No Comments »2009-10-10+01%3A15%3A52Hunter+West

Yasmin/Yaz Recall Way Overdue

September 22nd, 2009. By janem

yaz Yasmin/Yaz Recall Way Overdue

What comes first: will Bayer issue a recall of Yasmin/Yaz or will the drug company simply stop making its wildly popular and extremely dangerous birth control pill? For Bayer, the decision likely boils down to cost: can more claims be settled by taking the drug off the market? Poor Bayer has plenty to worry about these days. Not only are Yasmin/Yaz lawsuits related to life-threatening side effects stacking up, it was also served a warning letter from the FDA regarding quality control problems.

If and when Yasmin is taken off the market it will surely affect Bayer’s bottom line: In 2008 Yaz brought in $616 million for the company and Yasmin sales brought in $382. And sales increased from the previous year, mainly due to aggressive marketing campaigns that have since been called “deceptive” and “misleading” by the FDA. Advertising is a powerful tool: according to numerous Yasmin users I have spoken with, they had no knowledge of these side effects nor did they hear of any warnings: after all, if you knew Yasmin was life-threatening, you certainly wouldn’t be taking it!

So what’s taking the FDA so long to issue a recall? The agency must act on the countless reports of thrombosis, heart attack and stroke and even gallbladder disease associated with Yasmin and Yaz.

It wasn’t long ago that several fatalities were directly linked to the Ortho Evra birth control patch and it never did get recalled, even though last May the Public Citizen Health Research Group filed a petition on behalf of 80,000 consumers urging the FDA to recall Ortho Evra within six months. I wonder how many deaths it will take to remove Yasmin and Yaz from the market…

Tags: Yasmin, Yaz
Posted in Drugs/Medical | 140511 Comments »Yasmin%2FYaz+Recall+Way+Overdue2009-09-22+20%3A14%3A48janem