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.
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