Ortho-McNeil knew Ortho Evra Patch was Lethal

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Mon, 24 Apr 2006 19:52:39 -0400

[sSRI-Research] Pringle - Ortho-McNeil knew Ortho Evra Patch

was Lethal

 

 

 

 

 

fyi

 

http://www.lawyersandsettlements.com/articles/orthoevra.html

 

Ortho-McNeil knew Ortho Evra Patch was Lethal

April 19, 2006. By Evelyn Pringle*

 

Documents have surfaced in litigation that show Ortho-McNeil has been

analyzing the FDA's death and injury reports on women using the Ortho

Evra birth-control patch, and has charts that show a higher rate of

blood clots and deaths in women on the patch when compared to women

who take birth-control pills.

 

In addition, according to a November 11, 2005, article by the

Associated Press, an internal company memo shows that in 2003, the

company refused to fund a study comparing the Ortho patch to the

company's Ortho-Cyclen pill because there was " too high a chance that

study may not produce a positive result for Evra " and a " risk that

Ortho Evra may be the same or worse than Ortho-Cyclen. "

 

A number of doctors and health-care providers no longer prescribe the

patch, saying they do not want to take any chances. In Memphis, TN,

obstetrician and gynecologist, Henry Sullivant, told the Wall Street

Journal, that he has stopped writing new prescriptions and suggests

that his roughly 2 dozen users try other forms of birth control, such

as the pill or vaginal ring.

 

Pennsylvania State University, which provides health services for

42,000 students, is also no longer issuing prescriptions, and

according to the Journal, is considering contacting all students who

have been given prescriptions, even if they are no longer at the

university.

 

Since obtaining FDA approval in 2002, the Ortho patch has become a

very popular product. In 2004, according to the industry monitoring

firm, IMS Health, doctors wrote more than 9.4 million prescriptions

for the patch and sales topping $411 million. That is 21% more than

the top-selling brand of birth-control pill, IMS Health says.

 

The patch is about the size of a matchbook and the biggest draw is

that it eliminates the need to remember to take a pill every day. The

patch is applied to the lower abdomen, buttocks, upper arm or upper

body and worn for 7 days, and then replaced with another patch, for 3

consecutive weeks, followed by a week without a patch.

 

The system delivers hormones through the skin into the bloodstream and

contains progestin and estrogen, the same hormones found in

birth-control pills. Although the estrogen levels are similar in the

pill and the patch, before entering the blood stream the hormones in

the pill are processed through the digestive tract, while hormones in

the patch go straight to the bloodstream.

 

Both products work the same by: (1) preventing ovulation; an egg is

not released by the ovaries for fertilization; (2) thickening cervical

mucus so sperm are less likely to enter the uterus; and (3) causing

changes in the endometrium to reduce egg implantation.

 

In the case of adverse reactions, blood clots usually form in the

legs, and become serious problems if they travel to the heart, lungs

or brain. Symptoms include pain in the calf, shortness of breath,

chest pain, or coughing up blood.

 

When the patch was up for approval in 2000, it is now known that

doctors warned the FDA that clots could be a problem if the patch was

approved.

 

When conducting the review of more than 3000 women, doctors discovered

that two women had been treated for clots in the lungs. Ortho argued

that one case should not be counted as an adverse event because the

woman had undergone surgery. However, in report, a reviewing doctor

argued against that claim in capital letters.

 

" THE REVIEWER DOES NOT AGREE WITH THE SPONSOR'S ABOVE CONCLUSIONS, " he

wrote.

 

" The two cases of pulmonary embolus, a serious and potentially fatal

condition, must be counted as two cases ..., " the report said. " The

incidence rates quoted by the sponsor may be misleading. "

 

The doctor also said, " the label should clearly reflect this

reviewer's safety concern about a potential increased risk. "

 

In addition, the reviewer expressed concern that 211 women had gained

10 or more pounds during the trial and said the effectiveness of the

patch was reduced in women weighing over 198 pounds.

 

And although the report said it would be important to continue to

study problems with the patch once it was approved, there were no

requirements for follow-up studies other than the routine review of

reports filed by consumers, doctors and manufacturers.

 

In July 2005, the Associated Press conducted an investigation that

tracked adverse reactions in women using the patch since it came on

the market. In response to a FOIA request, the FDA provided the AP

with a database that contained roughly 16,000 adverse reaction reports.

 

The FDA's Adverse Event Reporting System (AERS) is a computerized

database designed to handle the agency's post-marketing safety

surveillance program for approved drugs. AERS receives reports from

manufacturers as required by law, and health care providers and

consumers send reports voluntarily through the MedWatch program. The

reports then become part of the AERS database.

 

Since the FDA estimates that it only receives reports on between 1%

and 10% of the adverse events that actually occur, the death and

injury rate for products is known to be significantly higher that

indicated in the database.

 

Within the group of 16,000 adverse reaction reports, the AP determined

that there were 23 deaths. Doctors who reviewed the 23 deaths said

about 17 appeared to be clot-related.

 

According to the AP, about a dozen women, mostly in their late teens

and early 20s, died from clots in 2004, and dozens more experienced

strokes and other clot-related problems.

 

In November 2005, the FDA warned that women using the patch were found

to have as much as 60% more estrogen in their blood steam than women

on the pill, putting them at a higher risk for potentially fatal side

effects.

 

Greater exposure to estrogen, the FDA said, may increase the risk of

blood clots. Experts say that clots are a known risk with hormonal

birth control because estrogen promotes blood coagulation.

 

On November 10, 2005, the FDA revised the labeling for the Ortho patch

to include a new, bolded warning to alert health care providers that

the amount of estrogen delivered through the patch produces a higher

level of estrogen exposure than birth control pills.

 

Johnson and Johnson has consistently denied knowledge of any problems

with the patch. However, according to a story by CBS News, documents

have surfaced in a lawsuit that show the company's own records reveal

that it received some 500 reports of serious problems associated with

the patch between April 2002 and December 2004.

 

Apparently, Johnson and Johnson has decided it's time to spring into

damage control. On April 9, 2006, the New York Post reported that

women " who suffered life-threatening blood clots and strokes on the

Ortho-Evra birth-control patch are receiving cash settlements from the

manufacturer, which allegedly failed to warn customers about the known

risks. "

 

" Ortho-McNeil Pharmaceutical of Raritan, N.J., a subsidiary of Johnson

& Johnson, " the Post said, " has settled a dozen lawsuits for millions

of dollars in the last few months, and more than 100 other suits are

pending. "

 

The settled cases include a lawsuit filed by Philomena Ugochukwa, a

37-year-old woman, who remains totally paralyzed after suffering a

massive stroke and brain damage while wearing the patch for less than

2 weeks.

 

The other 11 plaintiffs who settled out of court include women between

the ages 18 to 47, who suffered blood clots in the lung, leg, and brain.

 

One case involved 18-year-old Zakiya Kennedy, who died after

collapsing in a subway station, in which the medical examiner

determined the death was caused by a clot brought on by use of the

Evra patch

 

More lawsuits are being filed all across the country.

 

In November 2005, a federal lawsuit was filed in Madison, Wisconsin,

by the parents of the youngest patch victim, Alycia Brown, a

14-year-old eighth-grader, who died on May 7, 2004, after using the

patch for 8 weeks, when blood clots developed in her lower pelvis. The

medical examiner listed the patch as a likely contributing factor in

her death.

 

In another case, twenty-five-year-old, Sasha Webber, a Baychester, NY

mother of two, died of a heart attack in March 2004, after 6 weeks on

the patch.

 

In many instances it is difficult to determine with any degree of

certainty that a specific product did in fact cause a death or an

injury. Such is not the case with the Ortho patch, experts say,

because the injuries and deaths are occurring in young women of

child-bearing age, who in most cases have no prior history of health

problems.

 

 

Evelyn Pringle* is a member of our group. Vince