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On Thursday, November 10, 2005, the U.S. Food and Drug Administration (FDA) announced that it was updating the warning that must accompany prescriptions of the Ortho Evra™ birth-control patch, manufactured and sold exclusively by Ortho-McNeil, Inc., a subsidiary of pharmaceutical giant Johnson & Johnson, headquartered in New Brunswick, New Jersey.
According to the FDA announcement:

"The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen."

To access the FDA's "Questions and Answers--Ortho Evra (norelgestromin/ethinyl estradiol)," click here. Clicking on the FDA-supplied link to a PDF version of the newly-revised warning about Ortho Evra, as of 2:45 pm, PST, on Saturday, November 12, 2005, returned only an error message.

This announcement came two days after another announcement: "Parker & Waichman, LLP, Files Suit Against Ortho-McNeil Pharmaceutical, Inc. on Behalf of Victim of Ortho Evra Birth Control Patch--23-Year-Old Victim Suffered Multiple Pulmonary Embolisms after Using Ortho Evra for 10 Months."

The warning from the FDA came months after the July 25, 2005, announcement that "Ten women filed a lawsuit Monday against the maker of a birth control patch, claiming the device caused them to suffer strokes and blood clots, their attorney told CNN.

"The lawsuit -- filed in Hudson County, N.J., Superior Court -- alleges that the popular Ortho Evra birth control patch is 'defectively designed' and 'unreasonably dangerous.'

"The suit seeks punitive damages against pharmaceutical giant Johnson & Johnson and its subsidiary, Ortho McNeil, the patch's manufacturer."

You can read more about the alleged dangers of the Ortho Evra birth-control patch in this November 7, 2005, article from newsinferno.com entitled "Litigation Heats Up Over Allegations that the Ortho Evra Birth Control Patch Increases Risk of Blood Clots, Stroke, and Death," which features the warnings issued by consumer watchdog group Public Citizen.

You can directly access the Public Citizen warnings about Ortho Evra by clicking on the title of an article on their web site about this entitled "Birth Control Patch Linked to Dangerous Blood Clots: Do Not Use ORTHO EVRA."

Far from being surprising, the connection between elevated levels of estrogens in the body and the incidence of blood clot-related health problems is extremely well-established in the medical literature. The mechanism by which this occurs is also well-known: estrogens increase the ability of the liver to manufacture the "clotting factors" that regulate the rate at which human blood coagulates, for good or ill.

From the MedicineNet.com ("Written by Pharmacists/Reviewed by Doctors") web site discussing the estrogen estradiol, a primary component of the Ortho Evra birth-control patch:

"Estrogens increase the liver's ability to manufacture clotting factors. Because of this, patients receiving warfarin (Coumadin) need to be monitored for loss of anticoagulant (blood thinning) effect if an estrogen is added when warfarin is already being taken.

"Blood clots are an occasional but serious adverse effect and are dose-related. (The higher the dose, the more likely the clots.) Cigarette smokers are at a higher risk for clots, and, therefore, patients requiring estrogen therapy are strongly encouraged to quit smoking."

Scientists have even elucidated one possible mechanism by which increased estrogen levels can generate more effective (and hence potentially more dangerous) blood clotting through a biological pathway outside of the liver. In an article, entitled "Estrogen increases coagulation factor V mRNA levels via both estrogen receptor-alpha and -beta in murine bone marrow/bone," copyrighted in 2004 by the European Federation of Endocrine Societies and published in the European Journal of Endocrinology, Vol 151, Issue 2, 259-263, researchers conclude that:

"None of the selected genes was regulated by 17beta-estradiol in the liver. Interestingly, 17beta-estradiol increased mRNA levels of coagulation factor V in the bone marrow/bone. Furthermore, this stimulatory effect of 17beta-estradiol on coagulation factor V expression can be mediated via both estrogen receptor-alpha and -beta. CONCLUSIONS: The expression of bone marrow-derived, but not liver-derived, coagulation factor V is increased by estrogen treatment in mice. The pathophysiological importance of this finding for estrogen-induced venous thromboembolism remains to be determined."

It is "estrogen-induced venous thromboembolism" that is directly at issue in cases of dangerous or fatal blood clots allegedly induced by the use of the Ortho Evra birth-control patch.

Women are given estrogen not only to prevent ovulation and thereby effect birth control, but to treat the symptoms of menopause, through what is called "estrogen replacement therapy," or ERT.

Included in a discussion of this use of estrogen, on the Peace Health web site, found here, under the heading "Risks of estrogen replacement therapy," are these comments:

"Blood clots. ERT [estrogen replacement therapy] slightly increases the risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) which can be life-threatening. This risk is greatest in the first year of use. (7) A recent small study suggests that oral ERT slightly increases blood clot risk, but the ERT patch does not. When taken orally, ERT seems to increase a clotting factor in the blood; this does not happen with ERT that is absorbed through the skin. (8) [bolding added]."

Here are the footnotes referenced in this item:

(7) American College of Obstetricians and Gynecologists Women's Health Care Physicians (2004). Venous thromboembolic disease. Obstetrics and Gynecology, 104(4 Suppl): 118S–127S.

(8) Scarabin PY, et al. (2003). Differential association of oral and transdermal oestrogen-replacement therapy with venous thromboembolism risk. Lancet, 362(9382): 428–432.

The cited research by PY Scarabin et al. can be found here, and concludes by saying:

"Oral but not transdermal ERT is associated with risk of VTE [venous thromboembolism] in postmenopausal women. These data suggest that transdermal ERT might be safer than oral ERT with respect to thrombotic risk."

A November 10, 2005, Associated Press article by Martha Mendoza entitled "Warning issued for birth-control patch" reports that:

"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.'

"Last week, in response to AP questions about the Ortho McNeil memo, [Ortho McNeil spokesman Michael] Beckerich said in a written statement that 'decisions to fund studies are based upon scientific merit.'"

National Public Radio (NPR) covered the FDA Ortho Evra warning in a November 11, 2005, segment entitled "FDA Orders Label For Contraceptive Patch," by Joanne Silberner, which concludes by saying that:

"The FDA does not have the authority to order up the study that would clear everything up -- a head-to-head comparison of women who use the patch versus women on the pill. The manufacturer says it's working on two epidemiological studies, but wouldn't give further details."

Next week, Etopia Media Medical News Network will be investigating why there is no pre-existing national medical database containing information regarding the rate of dangerous blood clots among women using oral contraceptives versus those using transdermal ones, or the difference in the incidence rate of dangerous blood clots in both these classes of women and comparably-situated ones not using estrogen-based birth control, so that the public (and especially women considering their options in this regard) could have a low-cost, reliable, useful and easily-accessible way to answer their questions about this, without being dependent for this crucial information on the company that makes and sells the drugs in question.

There are many brands of oral contraceptives on the market, including: Alesse, Apri, Brevicon, Cyclessa, Demulen, Desogen, Estrostep, Levlen, Levlite, Levora, Loestrin, Lo/Ovral, Low-Ogestrel, Micronor, Mircette, Modicon, Necon, Nordette, Norinyl, Nor-QD, Ogestrel, Ortho-Cept, Ortho-Cyclen, Ortho-Novum, Ortho Tri-Cyclen, Ovcon, Ovral, Tri-Levlen, Tri-Norinyl, Triphasil, Trivora, Yasmin, and Zovia.

Ortho Evra from Ortho-McNeil is, at this time, however, the only FDA-approved transdermal contraceptive product on the market, although the FDA avoids saying that by telling visitors to its web site only that "Ortho Evra was the first skin patch approved for birth control."

You can hear plaintiffs' attorney Jason Mark, of the Parker & Waichman, LLP, law firm mention Ortho Evra's unique position as the only FDA-approved transdermal contraceptive path in an Etopia Media Medical News Network interview with him recorded on November 11, 2005, by clicking here.

You can see how Ortho McNeil trades on the fact that it's selling the only available birth-control patch ("ORTHO EVRA – The only once-a-week birth control patch"/"Ortho Evra® (norelgestomin/ethinyl estrodiol transdermal system)—On your body. Off your mind.™") on its own web site dedicated to marketing Ortho Evra by clicking here.