Beverly Hills IRB: When Two Is Not Five
4 CommentsBy Ed Silverman // February 2nd, 2011 // 10:02 am
It seems to remain true that some people just can’t count. Take the folks at West Coast IVF Clinic in Beverly Hills. A corporate entitly that is connected to the operation, which endeavors to help couples conquer infertility, received a warning letter from the FDA for violating rules pertaining to Institutional Review Boards. And these were rather basic rules.
To wit, federal law requires that IRBs have at least five members and one must be primarily concerned with so-called non-scientific matters (in other words, someone with a different background and mission). Also, no IRB member is allowed to participate in reviewing any project in which this person may have a conflict of interest. But an FDA inspection of the Napoli LLC, which is housed in the same Wilshire Boulevard location as West Coast IVF, found otherwise.
However, the FDA wrote Michael Kamrava, who also runs the clinic, that he “failed to adhere to the above stated regulations, in that your sworn, signed affidavit states you conducted a clinical study that was approved by the ‘local IRB at West Coast IVF Clinic,’ whose membership consisted of yourself and an embryologist.”
Kamrava, by the way, is the same fertility doctor who made national headlines two years ago after implanting six embryos into a woman who gave birth to octuplets. He had already helped her conceive six previous children (look here).
Anyway, the FDA reached its conclusion after an inspector visited the Beverly Hills clinic last fall and issued a 483 inspection report. There is no specific information in the warning letter, which was issued on January 21, as to what kind of product exactly was being studied. However, it would appear that all two of the IRB members - just two - were running a study for their own clinic. Somehow, Kamrava believed this would pass muster. If nothing else, he has a fertile imagination.
Elaine Schattner, M.D.
Thanks for raising this important topic, Ed. Functional and well-constituted IRB’s are critical to the quality of medical research and informed consent. But the case you picked is an easy target. The problem of COI’s in IRB’s may be widespread, and most instances subtler than this one.
industry insider
For the right price you can even get an IRB to approve a fake study.
http://www.yourlawyer.com/articles/read/16477
Pelfrey1
Obvious that Dr. Kamrava has difficulty counting…anything! From IRB members to fertilized eggs. Enough is enough. These sorts of flagrant errors in judgement just make it more difficult for reputable/regulation abiding physicians and IRB members to practice within the law!
alig
He needs to be in jail. And California should sue him to cover the medical costs of the octuplets.