First, I'd like to point out the ages of these women: 17, 18, 19, 20, 24, ect.... that's OUR age group. Thos are women who could have been going to school with us at the time they died or were injured from the patch.
Second, i'd like to do a little math. According to this article, which cites the FDA and FOIA as well as the AP and other news organizations, there are 9.4 million people per year that are perscribed the Patch. In a one year period between 2002 and 2003 the FDA logged 9116 cases of "adverse reactions" to the Patch (from blood clots to death). Also, according on one critic, only approximately 10% of all adverser reactions are ever reported to the FDA. That means in one year, while 9.4 million women are one the patch, about 90,000 of them experience patch related serious health complications. That's 1% of all women on the Patch. Ok, that doesn't sound like a whole lot, right? Well, let's just assume that on a typical college campus about 1 in every 10 women are using the Patch (a modest assumption). Now let's also assume that the campus population is about 4000. That means about 400 women are using the patch. One Percent of 400 is 4, so that means that approximately 4 women on OUR campus will experience serious health concerns (or will die) because of the Patch.
Will you be one of them?
The following synopsis is from:
http://www.lawyersandsettlements.com/articles/ortho_evra_sued.html?ref=article
"During its investigation, the Post used the FOIA to obtain FDA records that showed that 17 women between the ages of 17 and 30, who had used the patch, had died from unlikely causes in view of their age group, of heart attacks, blood clots, and possible strokes, since August 2002."
"Scores of other women on the patch, the Post reported, had suffered other complications including 21 life-threatening cases of blood clots and other ailments."
"Doctors who reviewed the reports voiced alarm over the number of fatalities. "This is a cause for concern," warned Dr John Quagliarello, a professor of obstetrics and gynecology at NYU Medical Center."
Critics also point out that these records do not accurately portray the number of women injured by the patch because according to the FDA, at best, only 10% of all adverse events get reported to the agency.
In 2005 alone, doctors wrote more than 9.4 million prescriptions for the Ortho Evra patch, according to IMS Health, a pharmaceutical industry-tracking firm.One case that was settled with a confidentiality agreement involved the first fatality attributed to the patch in the media which occurred on April 2, 2004, when 18-year-old Zakiya Kennedy collapsed in New York City while waiting for the subway.
The people who did catch the story about this 18-year-old dying so suddenly the few times it appeared were not surprisingly shocked. An autopsy revealed the cause of death was a blood clot called a pulmonary embolism that had moved to the lung as a direct result of using the Ortho Evra patch, the coroner ruled.
Thousands more young women have died or been injured needlessly.
In fact, the records show that back in 2000, the FDA scientist in charge of reviewing the pre-approval clinical trials submitted on the patch, warned FDA officials that blood clots could be a problem if the device was approved.
The reviewer also said "the label should clearly reflect this reviewer's safety concern about a potential increased risk."
The official specifically said the professional product labeling and information written for women using Ortho-Evra "should reflect the possible increased risk of venous thromboembolism (VTE) associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate)."
The reviewer might as well have been talking to himself, because when the device was approved, there was no warning on the label about the risks he identified and no requirements for post-surveillance studies other than routine monitoring of the adverse event reports from consumers, doctors and the drug makers.
Under the FOIA request, the FDA released approximately 16,000 adverse event reports associated with the patch ranging from a mild rash to death. Within these reports, the AP found 23 different deaths associated with the patch and the doctors who reviewed the 23 deaths, found about 17 to be clot related.
Nine months after the article in the Post about the 18-year-old women dying in the subway, a glimpse at the truth about the patch occurred in October 2004, when the first lawsuit was filed in Austin, Texas, on behalf of a paralyzed woman who suffered a stoke after only 12 days on the patch.
The lawsuit listed FDA records that showed forty-six women who were on the patch had suffered blood clot related injuries or death in a 1-year period between May 1, 2002 and April 30, 2003.
The plaintiff's attorney told CNN that the women listed in the lawsuit were all between 18 and 47-years-old, from Arizona, Arkansas, California, Colorado, Connecticut, Maryland, Mississippi, New Jersey, Ohio and Oklahoma.
The plaintiffs had all suffered debilitating long-term health problems as a result of using the patch. Plaintiff, Amanda Bianchi, 19, developed a 10-inch blood clot in her brain, which doctors said was a direct result of the patch she used for 3 months in 2004, and according to the complaint she had suffered two strokes.
And as far as what the FDA knew first-hand, according to the lawsuit's complaint, during a 17-month period between April 2002 and September 2003, the FDA logged 9,116 reports of adverse events due to of the patch.
On May 12, 2006, Knight Ridder reported the case of 20-year-old nursing student, Kristin Ribakusky-Templin, who experienced what started as a dull ache in her leg that within two weeks turned into shooting pains leaving her unable to walk and sent her to the emergency room where doctors found multiple blood clots deep in the veins of her lungs and leg. (THIS YEAR!)
On September 5, 2006, a Drug Newswire press release reported the latest federal lawsuit filed in Texas by a 24-year-old woman who suffered a miscarriage and developed life-threatening blood clots after using the patch.
According to the lawsuit, in 2004, Elizabeth Barroso, began experiencing chest pains and difficulty breathing after using the patch for three weeks and spent eight days in the hospital where doctors treated her for blood clots in her lungs.
Upon release from the hospital, Ms Barroso was placed on blood thinning drugs for 10 months. She became pregnant in October 2004, but later suffered a miscarriage.
In 2005, she became pregnant again and was forced to endure daily injections of blood thinners to prevent another miscarriage. Due to her injuries, all of Ms Barroso's future pregnancies will carry a risk of miscarriage and will require similar treatment.
From April 2002 to December 2004, Johnson & Johnson logged 27,974 adverse events among Ortho Evra patch users.
Other sources:
http://www.lawyersandsettlements.com/case/ortho_evra?ref=article
http://www.washingtontimes.com/national/20050716-114327-9302r.htm
http://www.medicalnewstoday.com/medicalnews.php?newsid=33512
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