Wednesday, November 10, 2004

Ortho Evra and [Clueless] Media Reports

Back in September, ABC aired a report about Ortho Evra, titled
Do Users of the Birth Control Patch Know Enough About Its Potential Dangers? Basically, ABC implied that using the patch increases your risk of death. The report mentioned 17 deaths, allegedly caused by blood clots in the lung (PE), in women using the patch. In my first post, I speculated that the report was inaccurate, and that ABC is either clueless, or is priming the jury pool in anticipation of a lawsuit against the patch's manufacturer. I have more information now, and it appears I was right [at a minimum, about the report being inaccurate]:

Ortho-McNeil Pharmaceutical, Inc., manufacturer of the patch, has been informed of only six deaths in patch users since its introduction in April 2002. The role of the patch in these deaths is undetermined, and several of the deaths were reported multiple times, accounting in part for the erroneous number of 17.

Little is known about the circumstances of 3 deaths. This is the information on the other 3 deaths:

One of the six deaths was due to myocardial infarction [heart attack] in a woman with both Down syndrome and Eisenmenger syndrome; her health had been deteriorating before starting contraception. Another death in Germany was due to suicide. One death in New York City was attributed at autopsy to a pulmonary embolism [lung blood clot]; the woman was not wearing a patch at the time of death. Whether she had been using the patch previously has not been determined.

Since apparently ABC couldn't be bothered with, you know, factual reporting, let alone useful context, let's review how one assesses risk and calculates incidence rates. First, you have to determine if an alleged death actually occurred. Then, you have to evaluate the potential association between a given exposure (wearing the patch) and outcome (death due to PE). This evaluation includes:

  • confirming the exposure--Did the woman who die use the patch at all?

  • identifying the temporal relationship between exposure and outcome--When was the woman who died using the patch, and for how long? Was she wearing it at the time of death, and/or for a period of time immediately preceding that?

  • determining the cause of death--What exactly was the cause of death?

  • identifying alternative causative factors--Was the patch wearer involved in a car accident, did she commit suicide, etc.?

  • Once you have all this information, you can calculate the risk of the outcome (the risk of PE death in patch users). So, let's assume that all 6 reported deaths were caused by PE, that they occurred in current patch users, and that there were no other alternative causes of death involved.

    We know that the patch has been used by about 4 million women x 2 years (this gives us 2.2 million woman-years of patch use).

    The risk of an outcome is determined by dividing the number of documented cases of that outcome (in our example, 6 PE deaths in patch users) by the number of individuals exposed per unit of time (in our example, 2.2 million woman-years); our result is 2.7 per million woman-years. What does this mean? Here's a practical way to understand this: the death rate per year from a blood clot is about 1 per million for women aged 15 to 24 years who don't use hormonal birth control; 3 per million users for women who use the combination birth control pill; and ~13.2 to 20 per 100,000 live births for pregnant women.

    So, patch users have a slightly lower risk compared to Pill users, and a considerably lower risk compared to pregnant women. Women who don't use the patch or the Pill, and who aren't pregnant have the lowest risk.

    Bottom line:

    Case reports of deaths need to be fully investigated by formal epidemiological studies. Until this is done, a casual relationship remains questionable. At the present time, no evidence suggests that the transdermal patch is associated with an increased risk of death compared with combination oral contraceptives.

    All I have to say about the ABC report is: what a sorry state of affairs!

    Grimes DA, Mishell DR Jr. Assessing Rare Event Reports: A Numerator in Search of a Denominator. Dialogues in Contraception. Fall 2004;8(7):7.

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    At 4:01 AM, Anonymous Anonymous said...

    What you also don't say is that are cases that happen through out the United States that do not get reported to the FDA or Ortho Evra. There is no law on mandatory reporting.
    If I remember correctly they also reported that there were 21 or 22 near fatal incidents with patch users. That is incorrect. On August 28, 2003 I was admitted to the hospital with a massive bi-lateral pulmonary embolus. If you want to see facts, then look at my cat scan. I have been told by every medical person who has seen my medical record, treated me since, that I should be dead. They look at my cat scan and are amazed. At the time of the "incident" I was wearing the patch. I had been wearing the patch for several months.
    I had no underlying cardiac or pulmonary condition. In fact if I had, I would have died. I have never smoked, rarely drank, would walk or run 2 to 3 miles a day. Since, I have had the genetic test done, and I do not carry the gene that would make me prone to clot. I had a perfectly healthy body..had! Now I have asthma, spent a year on coumadin.
    So yes you are correct the figures are wrong. I asked my doctor and checked with the hospital, my case was never reported. So that would make it 23 near fatal incidents. I am sure there are a lot more women out there like me, who's doctor never reported to the FDA.
    So when you talk to me. I know Ortho Evra, I have lived the nightmare and survived.

    At 1:41 PM, Blogger ema said...


    If I may offer a suggestion: I strongly advise either you, or your doctor, contact the manufacturer and report your case.

    At 2:42 AM, Anonymous Anonymous said...

    Shortly after beginning use of the patch, I began to experience major migraine headaches. I had had migraines before, but they were very few and far between, and were never bad enough to seek treatment on. In the past seven months, I have missed over 100 hours of work due to these severe migraines that now last for days and are so intense that even lying with my eyes closed is painful. Last October, I wound up in the emergency room which finally led to my first CT scan that came through, luckily, okay. I can almost guarantee that the week I have the patch off, I will have at least 3 days with a full migraine. My regular physician prescribed Imitrex for my migraines, which worked maybe 25% of the time, and when asked, she said she wasn't concerned that I was having so many migraines. When I asked my gynecologist about the correlation, she suggested I simply try putting the patch back on after 3-4 days off instead of 7. I am just now learning about the links to strokes, etc. ironically after picking up my next month's prescription. I have taken the patch off and will be changing my form of birth control tomorrow. I KNOW this is what has been affecting me and causing me so much pain as well as causing me to lose wages since I was not able to work with it. I would wager there are many others of us out there who have had similar experiences, and I suggest you also take this into consideration before promoting this product to anyone.

    At 9:45 PM, Anonymous Anonymous said...

    excellent discussion and explanation about the relative risks of the patch versus pregnancy and birth.

    I would love to know where you got your information about the deaths and number of patch users.

    The patch has prevented many unplanned pregnancies in young women who otherwise can't swallow or can't remember to take birth control pills.


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