NEWSLETTER 16: BAD ORTHO EVRA BIRTH CONTROL PATCH

Ortho Evra is a once a week birth control patch that supplies the sex hormones estrogen and progestin over a seven day period of time. Ortho Women's Health website, www.OrthoEvra.com, describes the potential risks as follows:

Important Safety Information: Most side effects of the Patch are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use the Patch are strongly advised not to smoke. Some women should not use the Patch, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

Hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60% more estrogen if you use ORTHO EVRA than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen exposure may increase the risk of side effects. However, it is not known if there are differences in the risk of serious side effects based on the differences between ORTHO EVRA and a birth control pill containing 35 micrograms of estrogen.

You should discuss with your healthcare professional whether ORTHO EVRA is a good method of contraception for you. The Patch does not protect against HIV or sexually transmitted diseases.

What stands out as an obvious misleading statement is the disclaimer where they are admitting their BCP Patch exposes women to a hirer amount of estrogen than what they would be exposed to using a competitor BCP Pill; 60% more. They go on to say that this may increase the risk of side effects. The next sentence, however, tends to inappropriately minimize the gravity of the concerns by saying, "...it is not known if there are differences in the risk of serious side effects based on the differences between Ortho Evra and a birth control pill containing 35 micrograms of estrogen."

On the website, www.OrthoEvra.com, under the link, "Is Ortho Evra Right for Me?", it inappropriately minimizes the risk of being exposed to the hirer level of estrogen by stating in the first paragraph: "ORTHO EVRA has been used by more than 4 million women since it was first made available in 2002. The birth control patch contains the same hormones used in other forms of combination hormonal birth control, such as the birth control pill. The types of health risks associated with ORTHO EVRA are consistent with those of other forms of hormonal birth control. Information about these risks is contained in the package insert included in every ORTHO EVRA package."

I felt this is where they should have clearly and in a straight forward manner described the potential disadvantages of their BCP Patch with a disclaimer similar to this: The main problem over the years with BCPs is the sex hormone levels. Over years there has been a steady strive to recommend BCPs with lower and lower levels of the sex hormones in them as medical research has clearly shown an increase in serious side effects including heart attack, stroke, blood clots in the legs and lungs along with death. Ortho Evra does contain more sex hormones than the low dose BCP Pills that are a safer alternative probably. However, the convience of the once a week patch along with the feeling that some young women will feel safer applying a patch than taking a pill has to be weighed against the alternatives.

So the bullet points regarding why Ortho Evra is bad include:

1. It is more dangerous than its competitors.
2. The risk is from the hirer level of sex hormones it contains.
3. Ortho Women's Health had a responsibility to communicate these risks in a straightforward manner. Instead, they minimized them with the proper "spin."
4. They capitalized on the generally mistaken belief that the patch would be safer as it is not being taking in internally. They had a duty to address this generally mistaken belief in a broader and stronger fashion in their advertisements.
5. Why has Ortho Evra been used in over 4 million women since it was first made available in 2002 if it has all these negative attributes associated with it? The answer is the inappropriate and negligent Madison Avenue spin that has been applied to this product for the purpose of sales.
6. A reasonable young women who is taught:
• the patch delivers the same sex hormones to her bloodstream as the pill.
• the lowest dose is the safest.
• the patch contains more sex hormones than competitor low dose BCP Pills.
...would probably not chose this product over others.

Sincerely:

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRP
Member, ACFEI (American College of Forensic Examiners Institute of Forensic Science)
Expert Medical Witness, ExpertMD
PI (Principal Investigator), DSI (Drug Study Institute)
Board Certified Internist, JPMC (Jupiter Preventive Medicine Center)
DABIM (Diplomat American Board of Internal Medicine)
FACP (Fellow American College of Physicians)
CPI (Certified Physician Investigator) by the APPI (American Academy of Pharmaceutical Physicians)
CCTI (Certified Clinical Trial Investigator) by the ACRP (Association of Clinical Research Professionals)
CCI (Certified Clinical Investigator) by the DIA (Drug Information Association)
CCRC (Certified Clinical Research Coordinator) by the ACRP (Association of Clinical Research Professionals)
CCRP (Certified Clinical Research Professional) by SoCRA (Society of Clinical Research Associates)
Member, SIMPD (Society for Innovative Medical Practice Design)
Member, ACPM (American College Preventive Medicine)
Ethics Committee Member, Jupiter Medical Center
IRB Member, Jupiter Medical Center
Founder, CertifiedResearchers.com