But several months after the event, on September 23, 2004, Ms Kennedy's father and grandmother were interviewed by ABC News and said the young woman had experienced symptoms but did connect them to the patch or take them seriously. "She was complaining about her head was hurting - she felt pain in her leg and she had felt dizzy," her father recalled.
"She was complaining about pains in her leg or in her shoulder," he said. "She thought it was from her exercising."
Roberta Alloway, Ms Kennedy's grandmother, said the drug company should be warning people about the lethal side effects of the patch. "They need to really let people know that my granddaughter and other people have died from this patch," she told ABC news.
"I can't bring her back," she said. "But I want something to bring attention to these young women."
Notwithstanding the high statistics of death and serious injuries revealed by the New York Post based on the FDA's own database, it would take nearly 20 more months for the FDA to force J&J to add a warning to the label of the Ortho patch to alert women about the risk of blood clots, strokes, and heart attacks.
On November 11, 2005, the day after the waning was announced, Dr Sanjay Gupta, CNN's senior medical correspondent, predicted on CNN that the warnings would probably, at a minimum, "mean a complete redesign of the patch so it doesn't deliver as much estrogen and doesn't put women at greater risk for blood clots."
"Or," he stated, "it could mean the demise of the patch altogether."
Unfortunately, neither occurred and as a result, thousands more young women have died or been injured needlessly.
According to J&J at the time, the injuries and deaths with women on the patch were "consistent with the health risks" of the birth control pill, which "kills 0.3 to 1.9 women in every 100,000 users ages 15 to 29."
However, that assertion was proven to be a bold-faced lie on the part of Johnson & Johnson, by FDA reports obtained by the Associated Press under the FOIA, that showed that in 2004, when 800,000 women were using the patch, the risk of a woman dying or suffering a survivable clot while on the patch was three times higher than women using birth control pills.
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.
While reviewing the trials, the scientist discovered that two of the 3,300 women using the Ortho Evra patch had been treated for blood clots that had traveled to their lungs. J&J argued that one of the two women should not be counted because she had underwent surgery, but the FDA reviewer, using capital letters to emphasize the point, disputed that argument stating:
"THE REVIEWER DOES NOT AGREE WITH THE SPONSOR'S ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases..." "The incidence rates quoted by the sponsor may be misleading."
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)."
In addition, he expressed concern about the fact that 211 women out of 3,088 had gained 10 or more pounds during the trials and noted that the effectiveness of Ortho-Evra was reduced in women weighing more than 198 pounds.
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
