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 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.
