The Wall Street Journal (WSJ) is reporting that: “Many doctors have stopped writing prescriptions for a popular form of birth control after the Food and Drug Administration warned earlier this month of increased hormone exposure to women who use it.”
According to the WSJ: “[A] number of individual practitioners and major health-care providers say they don’t want to take any chances. In Memphis, Tenn., obstetrician and gynecologist Henry Sullivant says he has stopped writing new patch prescriptions and suggests that his roughly two dozen patch users try other forms of prescription contraceptives, such as the pill or a monthly vaginal ring. Pennsylvania State University, which provides health services for 42,000 students, is no longer issuing prescriptions and says it is considering whether to contact all students who have been given prescriptions for Ortho Evra, even if they are no longer at the university.”
In a effort to exercise caution, similar actions are being taken by many other university health officials including those at the University of Texas at Austin, Stanford University, the University of California, Berkeley, and Connecticut College in New London, Connecticut where one patch user experienced a blood clot in her lung last spring.
In addition “Lee Shulman, incoming board chairman of the Association of Reproductive Health Professionals, says he expects that ‘there will be a decrease in use’ of Ortho Evra, at least over the next several months. He adds that he has been inundated with doctor and patient phone calls asking whether the patch is safe to use.”
When asked for his thoughts on the matter, Jerrold Parker, managing partner of Parker & Waichman, a law firm with considerable experience in pharmaceutical and medical malpractice litigation, told us that: “This is a particularly dangerous situation for doctors and major healthcare providers like colleges and universities since the warning involved ere is quite strong and very specific. The danger posed by the patch is a very real one and it’s not a secret anymore.”
Mr. Parker continued: “There are also many well-publicized law suits out there alleging deaths and catastrophic injuries from the very side-effects contained in the new warning.
Thus, any doctor writing a prescription for the patch from this point on is doing so at his or her peril. Given the potentially fatal side-effects of the drug, writing a prescription now could be considered irresponsible in terms of good and accepted medical practice especially if an otherwise healthy woman is paralyzed or dies from a stroke caused by blood clots after using the patch.”
Parker sees this as “a malpractice case just waiting to happen. It’s no wonder so many healthcare providers are rethinking their policies and recommending alternative medications to their patients. Their caution is well-advised at this point.”
Only last week, another high-profile wrongful death case was commenced against Ortho-McNeil and Johnson & Johnson. It involves Alycia Brown, an eighth-grader in La Crosse, Wisconsin, who died of blood clots in her lower pelvis on May 7, 2004. She had been using the Ortho Evra birth control patch for about eight weeks.
The federal law suit filed in Madison by her parents claims the patch was the cause of their daughter’s tragic death. The La Crosse County medical examiner has found that Ortho Evra was a likely contributing factor in Alycia’s death.
Although many lawsuits have already been commenced against Ortho-McNeil and its parent company, Johnson & Johnson, for injuries and deaths allegedly caused by the patch, the 14-year-old is now the youngest known victim.
The girl’s mother had feared that her daughter was having sexual relations. The patch was decided upon because the girl was afraid to have a birth control shot because she was afraid of needles. The mother wanted to avoid the possibility of Alycia ruining her life with an unwanted teenage pregnancy. What happened, however, was far worse.
Ortho-McNeil has finally acknowledged the fact that women who use its Ortho Evra birth control patch are at a significantly greater risk of blood clots, stroke, and death than woman who use other forms of oral contraceptives.
The company now admits that women who use the patch can be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill instead.
Several lawsuits have already been commenced around the U.S. alleging that serious injuries and deaths have been caused by the Patch. Two weeks ago, CBS News presented a story concerning documents produced in the course of a pending lawsuit involving a young mother who was paralyzed by a stroke only 12 days after she began using the patch. She is now a total invalid.
According to that story, Ortho-McNeil’s own records show the company received some 500 reports of serious health problems associated with the patch between April 2002 and December 2004. During that time only 61 such reports were received with respect to all types of existing oral contraceptives.
In addition, there were four times as many strokes in women using the patch as in women using oral contraceptives even though three times as many women were taking those other forms of birth control.
Finally, the evidence indicates, that in medically confirmed cases, the risk of blood clots is 14 times as high with the patch.
An investigative report published by the Associated Press on July 18, 2005 linked the birth control patch, which contains a combination of norelgestromin and ethinyl estradiol, to an increased risk of blood clots and deaths (compared to older contraceptives) in some young healthy women.
Ortho Evra, like the other hormonal contraceptives, has a black box warning about an increased risk of cardiovascular adverse reactions in older women who smoke. This type of warning is the strongest that the FDA can request. In an Associated Press follow-up story, the AP stated:
“Documents released to attorneys as a result of that litigation show Ortho McNeil has been analyzing the FDA’s death and injury reports, creating its own charts that document a higher rate of blood clots and deaths in association with the patch than with the pill.
In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was ‘too high a chance that study may not produce a positive result for Evra’ and there was a ‘risk that Ortho Evra may be the same or worse than Ortho-Cyclen.’”
The patch, like many oral contraceptives, contains two hormones, a progestin and an estrogen. The progestin in Ortho Evra is a new drug (2001) known as norelgestromin, and the estrogen is an existing one known as ethinyl estradiol.
Ortho Evra was approved by the Food and Drug Administration (FDA) in November 2001 and is the first contraceptive product to be approved as a skin patch. It was launched and marketed in a series of “glitzy” television ads featuring “sexy models.” (CBS 11/2/05).
In 2004, the drug accounted for more than 9.9 million prescriptions with sales topping $411 million.
Contraceptives are often referred to as second- or third-generation based on their progestin component. Since some experts classify norelgestromin as a third-generation progestin, Ortho Evra is considered third-generation contraceptive.
Public citizen first listed some third-generation oral contraceptives as “DO NOT USE” drugs in 1998 and 1999 because of an increased risk of blood clots compared to the older, second-generation birth control pills. Thus, elevated blood levels of progestin as well as estrogen are possible with the Patch.
The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from last year.
Since the FDA estimates that it receives reports of only between 1% and 10% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.
The Associated Press also analyzed the reviews of clinical trial results done by FDA physicians and scientists prior to the drug’s approval. Those results were submitted for review by Ortho-McNeil in support of Ortho-Evra and are available on the FDA’s Web site at:
Significantly, Ortho-McNeil and the FDA medical officer reviewing Ortho Evra strongly disagreed about whether two cases of blood clots in the lungs (pulmonary embolus) in young women participating in the pre-approval clinical trials were caused by the drug. The FDA medical officer wrote:
“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the group” [emphasis in the original].
The FDA medical officer also included the following statement in his comments:
The professional product labeling and information written specifically for women using Ortho-Evra “should reflect the possible increased risk of venous thromboembolism (VTE) [blood clots] associated with this new transdermal combination hormonal contraceptive containing the new molecular entity progestin norelgestromin (17d-norgestimate).”
In addition, the medical officer expressed concern that 211 out of 3,088 women (6.8%) in the pre-approval clinical trials gained 10 or more pounds in the trials and noted that the contraceptive effectiveness of Ortho-Evra was reduced in women weighing or than 198 pounds (90 kilograms).
Since contraceptives are usually prescribed to young, healthy women they should be associated with the lowest possible risk of serious adverse drug reactions.
Blood clots in the lungs were seen in two women given Ortho Evra in clinical trials conducted before the drug was even approved (in addition to several similar cases after the drug was marketed).
There is also no evidence that the patch is a superior contraceptive compared to older second-generation birth control pills. As stated in the September 2005 issue of Worst Pills Best Pills (published by Public Citizen); “Rarely do randomized pre-approval studies, the scientific ‘gold standard’ for proving safety or efficacy, present such strong evidence of a serious problem.”
As a result of what it considers strong evidence of the increased risk of blood clots and death, Public Citizen states: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.”
The Ortho-McNeil’s Press Release is a rather difficult document for the average person to understand. If its implications are considered with respect to the amount of estrogen that can be released in a given period of time, however, the result is shocking since that amount can easily exceed 50 mg which is well beyond the level already determined to be unsafe.
A previous study conducted with respect to another contraceptive product (the “vaginal ring”) documented these excessively high levels of estrogen associated with the Patch over nine months ago in the journal Contraception.
In addition to the risks already discussed, cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. As a result, women who use hormonal contraceptives, including ORTHO EVRA, should not smoke.
The mounting litigation focuses on the claim that Ortho-McNeil knew of the blood clot risk and even disagreed with the FDA medical officer who suspected the two incidents that occurred during the clinical trial were related to the drug.
A lawsuit was filed in July 2005 against Ortho-McNeil on behalf of a 30-year-old woman who suffered fatal blood clots thought to be linked to the Ortho Evra risk. The woman was admitted into the intensive care unit shortly before her death suffering from severe headache, visual problems, vomiting, and nausea.
The other deaths reported in connection with Ortho Evra risk factors were the result of heart attacks and strokes. One of the most recent deaths linked to Ortho Evra was suffered by a 25 year old woman who suffered fatal headaches thought to be linked to a surge of hormone release from the birth control patch.
Before the Alycia Brown case was filed, the youngest woman to die had been an 18 year old college student who collapsed in the New York subway. Many other women ranging in age from 18 to 27 have also sued Ortho-McNeil.
In September, Parker & Waichman, a major New York based plaintiffs’ personal injury law firm that is heavily involved in pharmaceutical litigation announced that it had filed suit against Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc., on behalf of a 37-year-old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months. The suit was filed U.S. District Court for the District of New Jersey.
According to the complaint in that lawsuit, from April 2002 through September 2003, the U.S. Food and Drug Administration logged 9,116 reports of adverse events because of the patch, according to the suit.
This is significant since there were only 1,237 adverse reports by women taking the leading oral contraceptive, Ortho Tri-Cyclen, over a six-year period even though that drug was used by almost six times as many women as Ortho Evra in 2003.
As Lorie Brown, Alycia’s grieving mother, told reporters last week: “I’m out to let people know: get off (Ortho Evra). That’s my biggest goal here. I didn’t save her life, but maybe I can save somebody else’s.” It seems that many responsible doctors and major healthcare providers are trying to do the very thing.