Fwd: Off-license IVB

[Chris Alston <alstonc@odrge.odr.georgetown.edu>]

>From: Rob Barish <ROBBARISH@AOL.COM>

>Greetings colleagues,
>
>I waited a few days to see if my friend Steve Balter would post a comment on
>this topic. Since he hasn't yet, I'll put in my two-cents worth and let him
>make his own comments if he so chooses.
>
>By the way, I'm his principal back-up at the Cardiovascular Research
>Institute in New York. The physicians in that group, working in the cath lab
>at Lenox Hill Hospital are well known for their collaboration with the groups
>at Scripps and the Washington Hospital Center and are major contributors to
>the Cordis (Ir-192 gamma) research program as well as to the Novoste program
>(Sr-90 beta). In addition, work with the Guidant (P-32 beta) system will be
>starting shortly.
>
>Thanks to Dr. Balter's skills in navigating the NYC Bureau of Radiological
>Health (did you know that New York City is, by itself, an agreement state),
>Lenox Hill Hospital received a license for the use of the Cordis and Novoste
>systems in conformity with the provisions approved by the FDA. So some
>patients are now treated outside of any research protocol and they are
>getting billed. I say "some patients" because with respect to the clinical
>applications and dose studies now underway in the research program, the FDA
>approved use is relatively limited. For example, in ongoing research,
>patients are treated with Iridium catheters with 6, 10, 14, 18 or 22 seeds.
>In the FDA approval now in effect, only the three shorter catheters may be
>used. Similarly, Novoste has a 3 cm and 4 cm device in ongoing clinical
>trials. Only the device with the 3 cm source length is approved, the other is
>still investigational.
>
>That's the important point in this discussion. The NRC or your local
>agreement state does not handle OFF-LICENSE use of radioactive materials the
>way the FDA regulates OFF-LABEL use of pharmaceuticals. As long as a DRUG is
>FDA approved, a physician can write a prescription for it without violating
>the law. Of course, the doctor has to deal with the possible legal
>consequences if the drug harms a patient and/or is clearly inappropriate.
>That's the subject of malpractice litigation.
>
>In the case of a radioactive materials license, the specific conditions of
>use are spelled out. For the two IVB systems now approved, the user MUST
>conform to the "package labeling." These are documents officially filed by
>the two vendors with the FDA. Any deviation from those conditions will likely
>subject the violator to a very public and damaging action from their local
>regulatory authority.  In addition, as a high-dose rate brachytherapy system
>in which positioning of the sources is accomplished by hand, messing around
>with "source stepping" in the coronary arteries or using the devices in ways
>that some cardiologist would like to "try," subjects the radiation oncologist
>and physicist (both of whom are on the radioactive materials license) to
>penalties that include criminal prosecution.  This falls into a category
>which the NRC calls "Willful Violation." Here is a quote from their
>enforcement manual on the subject:
>
>"A willful violation or an act of wrongdoing is one in which an NRC
>requirement has been breached with some intent or purpose to commit the
>breach, rather than through mistake or error. Wrongdoing consists of both
>deliberate violations of NRC requirements and violations resulting from
>careless disregard of or reckless indifference to regulatory requirements
>amounting to intent."  (NRC Enforcement Manual)
>
>At this time, the FDA approved uses of the Cordis and Novoste systems are
>very limited. Within six months or so newer applications based on later
>clinical data should enlarge that scope of use, e.g. approval for the longer
>source trains. Until that time, it is my suggestion that you do not
>jeopardize your career by participating in any use of these devices that is
>not strictly in conformity with the "package insert."
>
>Regards,
>
>Rob Barish
>
>PS. When I was at the Marsden, using an off-license was often followed by
>"going over the road" for a tasty meal.


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