Tuesday, November 15, 2005

V. Special Educational Post

We had a v. entertaining research talk yesterday re: "Bowel Function during Pregnancy" and I learned about the Bristol Stool Scale, a patient-friendly tool with which to classify poo. I loves me a good poo talk but even I couldn't finish my black bean soup after this popped up on screen:



Fabulous!

Right after the research talk the drug rep who bought us dinner came in to give his spiel. Last Thursday the AP came out with a pretty damning article re: Ortho Evra (The Patch) and risk of venous thromboembolism. There's kind of a gynormous freak-out right now because it's been all over CNN that the risk of VTE with the Patch was 3x the risk of VTE with the Pill because it has a bit more estrogen.

The warning from Johnson and Johnson subsidiary Ortho McNeil, makers of Ortho Evra, says women using the patch will be exposed to about 60% more estrogen than those using typical birth-control pills because hormones from patches get into the bloodstream and are removed from the body differently than those from pills.



Well that's part of it; the estrogen in the patch is more efficiently transferred to the bloodstream because it's not in a form that has to be digested first. Basic physiology: The pill offers a fluctuating level of estrogen, while the Patch provides a consistent level of estrogen 24/7. The NET AREA under the estrogen curve of Evra > the sum of the area under the Pill estrogen curve area by 50-60%, this is true. BUT because the Pill has peaks and troughs in estrogen, the HIGHEST amount of estrogen a user is exposed to at any one time is actually LOWER with the patch than with the pill.

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.

This is a half truth. There haven't been any studies comparing the incidence of VTE between the Patch and the Pill; what this refers to is the number of VTE incidents reported to the FDA by Patch users. So, this conclusion isn't necessarily evidence-based.

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."
That does sound scary but again I don't think we're hearing the whole story; OE admits that decisions to fund studies are based on scientific merit. For the record at present Ortho-McNeil is conducting a large-scale prospective cohort study comparing the actual prevalences of PE, DVT, and stroke in Pill vs. Patch users. I hope they have a control group in there too.

Net result: We don't know if the risk is greater with the Patch or the Pill. If you're freaked out call and get your Rx changed from the Patch to OCPs, it's very easy to do. Don't just go off your medication though. (What's ironic is that the risk of VTE with unintended pregnancy exceeds the risk of VTE with the Patch or the Pill, yet women (esp smokers) might possibly go off hormonal contraceptive all together after this scare.)

(And I'm sorry and this is completely unrelated but the Ortho Evra drug rep was SMOKIN' HOT. I think it's hilarious how the drug companies are starting to realize most ob/gyns today are female and are trotting out the hot guys to sell birth control. My cute friend Rashaun from college was hired by Johnson & Johnson to sell OrthoTriCyclen Lo when he graduated. He was assigned to FARGO, NORTH DAKOTA of all places. He was afraid he would be the only black person in both Dakotas.)

(Also, I googled "Ortho Evra" and "blood clots" to see all the press that was out there so far and the first thing that popped up was 5 billion lawyer websites inviting you to join their lawsuits. Big surprise there.)

And oh what the hell, as long as I'm in the mood:

Plan B: I just got a NARAL update email that counts down how long Bush's FDA has fnur-fnurred about making a decision re: making emergency contraception available over the counter. Right now we're at 1,734 days, which is how long it's been since the FDA's own advisory board of experts overwhelmingly recommended improving access to Plan B. (At Northwestern everyone is entitled to get it up to twice a year for free! Rock on!)

Samuel "The Constitution Does Not Protect A Right to An Abortion" Alito: "The White House can’t expect Americans to feel secure while they pursue the dual strategy of telling the public to ignore Alito’s own written documentation of his legal philosophy but simultaneously using it to assure far right groups of his anti-choice positions." says Nancy Keener. Word.

1 comment:

Serena said...

That stool picture killed my appitite. All that birth control Ortho evra stuff was interesting. My friend is on it I should tell her about that. I like your entries.