The scientist also said that it would be important to study patch users for clot problems after the patch came on the market.
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.
The Associated Press also reviewed what had happened since the Ortho Evra patch arrived on the market in 2002, and determined that deaths of women on the patch appeared to be at least 3 times higher than women on the pill.
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.
But even after these reports became public, J&J continued to claim that none of the deaths could be directly attributed to the patch.
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.
In the same 12 months, the lawsuit said, only half as many women taking birth control pills had developed clots even though there were six times more women on birth control pills.
Comparatively, the lawsuit alleged, 11 times more fatal or life-threatening clots were suffered by women on the patch when compared to women taking the pill.
On July 25, 2005, CNN reported on a lawsuit filed in New Jersey, on behalf of 10 women, who alleged the Ortho Evra patch had caused them to suffer blood clots and strokes.
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.
"I don't want any other woman to have to go through what I'm going through," Ms Bianchi told CNN. "It's not fun to have to get up and not be able to go to school and live the life that you were living," she said.
When contacted by CNN, sticking to its guns, J&J repeated its usual mantra of denial in a written statement saying, "The types of adverse event reports that have been received for Ortho Evra are consistent with the health risks of other hormonal birth control methods and the Ortho Evra product level."
And a spokeswoman for the industry owned FDA, did the same. She totally ignored the FDA's own database statistics to the contrary and told CNN:
"The risks of using this product are similar to the risks of using birth control pills, including an increased risk of blood clots, heart attack, and stroke. The data is not precise enough to tell whether there is an increased incidence (with the patch)."
No woman should put these poisons on their skin or ingest birthcontrol pills. I started the pills in 1976 and within several months was having 4-5 migraines a week.It was seven years before the damage was corrected and the migraines ceased though I had ceased the pills immediately. Fortunately, I read that week I stopped that they had never been sufficiently tested by endocrinoligists!! I stopped IMMEDIATELY. Profits the game, not your health.Never had headaches in my life, I was 36 then.I learned of other horrors from women who took the pills. Women must take control of their bodies and listen to intuition. Nature did not intend these artificial methods or poisons to enter our bodies and disrupt natural rhythms. Let men take the burden for a while and not have women making it so easy for them to have unlimited and undisciplined sexual relations. Many other less harmful methods. That this company continues to foster the patch onto women, whose primary goal always is to please their man, is evil and cruel knowing of their subsequent threat to life.
Boycott, ban these patches!!! Most everything marketed on TV is suspect. Learn the natural way to good health, keep manufactuted poisons out of your bodies except where it is a matter of life and death. Drugs are crippling the people of this nation. Read Kevin Trudeau's book "Natural Cures THEY don't want you to know about."
by
Starchild (0 articles, 0 quicklinks, 0 diaries, 12 comments)
on Thursday, September 21, 2006 at 8:37:02 AM
THIS IS NOT NEWS! It is a blatant advertisement by a lawfirm
This is not a "news" article, nor it it an op-ed -- it is a blatant advertisement for Lawyers and Settlements.com! How irresponsible for opednews.com to accept and post such a submission. Is there no editorial board that reviews submissions???
PALEEZE!
by
Janet (0 articles, 0 quicklinks, 0 diaries, 2 comments)
on Friday, September 22, 2006 at 1:04:51 PM
Then could you please direct readers to a mainstream media sources that has published the information I have found during my investigation and included in this report?
I am not a shill for attorneys and I could care less about waht attorneys make. I am a shill for anyone who has been harmed by the gigantic pharmaceutical industry and who don't have a chance of getting one thin dime going up against a drug company alone.
If the mainstream media would do its job instead of trading its soul to the highest bidder under the guise of "advertising dollars," also known as bribes, to keep its mouth shut about the harm these drug companies do to the average Americans, reporters like myself would not have to find other forums to get the word out.
Evelyn Pringle
by
Evelyn Pringle (186 articles, 0 quicklinks, 0 diaries, 10 comments)
on Friday, September 22, 2006 at 1:40:06 PM
THIS IS NOT NEWS! It is a blatant advertisement by a lawfirm
It is NOT that the subject matter is not news -- indeed it is. But to use that lead (500 Ortho-Evra Birth Control Patch Victims Sue Johnson & Johnson) and to end with a link to the law firm...hey, wait a minute -- all of your "artilces" end with that link to lawyersandsettlements.com/...are you on their payroll?!?!?
by
Janet (0 articles, 0 quicklinks, 0 diaries, 2 comments)
on Friday, September 22, 2006 at 2:34:37 PM
I get offered a topic and if I want to investigate it and submit a report, I take the job. My investigation is all my own and not a word of my work is edited by anyone.
The headline you mention is straight out of the company's latest SEC filing and I think it is highly newsworthy. Furthermore, if there are 500 more young women out there that have been injured by this patch, that this company knew caused this problem, I hope they sue the company as well.
As far as caring if people know that I get paid by the online marketing firm listed at the bottom of the article, I obviously am not trying to hide the identity of the firm that commissioned me to write the report and I really don't care who knows.
Again, if you can direct readers to a mainstream media source that will alert the public to all of the information that I dug up and included in my report, please do so I can move on to another topic.
Cheers,
Evie
by
Evelyn Pringle (186 articles, 0 quicklinks, 0 diaries, 10 comments)
on Friday, September 22, 2006 at 3:57:10 PM
