Ortho Evra Patch: How Safe are the Clinical Trials?

Las Vegas, NVOn its website, Novum Pharmaceutical Research Services states that "Your participation in a clinical research study provides quality information to pharmaceutical companies" and it also states that the "Novum experience is healthy because you receive a free screening physical." One such study it recently conducted with the drug company was on the Ortho Evra Patch.

How can the Patch be considered a "healthy experience" after countless women have suffered blood clots, stroke and even death? But you can collect $3,000. Tempting? Or is it like playing Russian Roulette?

Novum recruits people year-round looking for participants in clinical trials. This ad (below) was placed on Craig's List March 20, 2007-- it only mentioned Gastrointestinal Upset and headache as common side effects.

Ad Posted on Craig's List
Healthy Females needed to participate in a clinical study.
Drug Type: Birth Control Patch (Ortho Evra)
Common Side Effects: Gastrointestinal Upset, and Headache

Screening Date: March 20th (8-11 and 1-3)

Basic Eligibility:
Ages 18 and older
Non smoking for at least 6 months
Not taking any prescription medication
Able to tolerate multiple blood sample collections Average height and weight (BMI 18-30) with a maximum of 198 lbs Comfortable staying a few nights in our facility Can not be on any form of hormonal birth control for at least 30 days prior to study start

Compensation: $3000.00
_________

I spoke to a Novum recruiter by phone and she told me that the tests are perfectly safe because participants only stay on the Patch for about one week. So what is the point? In real life, you use a contraceptive device for more than a week. Have any trials been conducted on the Patch that reflect real-life situations, that is, have women been paid to wear the Patch for months or years in one stretch?

Clinical trials are important and necessary and if carefully conducted, they should be the safest and most expedient way to find treatments that work and improve health.

Why Clinical Trials are Conducted

• To find out if a new drug or device is safe and effective for people to use.


• To compare existing treatments to determine which is better.


• To study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects.


• To learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.

How does the Ortho Evra Patch justify a clinical trial? Many women have died from blood clots as a result of wearing the Ortho Evra Patch. Why can't the FDA step in and "ask" Ortho McNeil to take it off the market?