I’ve seldom heard of impersonating an FDA official. Evidently its happening. Here is the FDA press release:
FDA Warns Public of Continued Extortion Scam by FDA Impersonators
A study conducted by FDA and a different study published in the Journal of the American Medical Association (JAMA) have both found problems regarding the quality of the data used to approve cardiovascular medical devices, the NY Times reported today (‘F.D.A. Seeks Better Data From Tests Of Devices,’ by Barry Meier, page B1). Although the researchers came to some different conclusions, both studies showed serious problems with the way clinical trials are conducted, in particular with the follow-up of study participants. I can’t do a better job of explaining it than Mr. Meier of the Times so I won’t try. The URL to his article is below.
However, I can comment on the problem of “Lost to Follow-up” in device trials. I have audited a number of clinical trials for cardiovascular devices and found attempts to follow up with seriously ill participants to be lacking. At one clinical site, patients would be released to the institution’s extended-care facility where they died from complications of the surgery or disease progression. The clinical investigators had no way of communicating with their own affiliated facility and would learn of the deaths months later, if at all. At least from my own perspective, the problems identified in the two studies are very real.
It looks like FDA will develop guidelines for tougher standards. Hopefully the discussions that result from the two different studies will help determine the best approach. The FDA study was conducted by scientists at Beth Israel Deaconess Medical Center and FDA. The JAMA published study was conducted by researchers at the University of California, San Francisco.
It was enough to make my blood boil. A family member who has hearing problems passed me an announcement for a “Field Trial Notification” that contained wording that made it sound like a legitimate clinical trial. Things like, “You have been selected to receive this invitation to participate in this study” and “We will be selecting only 20 local residents as candidates for this field test at this time.” The notice gave three “inclusion criteria” similar to what you would see in a legitimate ad for a clinical trial. However, these folks are just peddling their product. There is no research going on and people who answer the ad are going to have to pay a price, which is never stated, for the hearing aid.
There are some dead giveaways that this isn’t a study of any kind. Three things are:
1. There is no clear statement of research, only the suggestion of a “study” and a “field test.”
2. It uses language such as “incredibly discreet” and “comfortable.”
3. It states that “Your satisfaction is 100% guaranteed.”
If this was a legitimate clinical trial an institutional review board (IRB) would have to approve the language in all advertisements and no legitimate IRB would ever allow such suggestive language. This is a scam to try to sell a particular brand of hearing aid, pure and simple. This type of deceptive advertising has been around since they invented snake oil. Its one of the reasons we have an FDA. The new leadership at FDA seems intent on going after the most fraudulent shysters, particularly with phony H1N1 “cures.” They’ve got a big job in front of them.
I’m all for alternative therapies and have an appointment with my acupuncturist tomorrow. I know some fine people using homeopathic medicines. There are also a lot of frauds out there and the ones who target seriously ill people with difficult health problems for nothing other than personal gain should be tarred & feathered and run out of town on a rail. (In my humble opinion.)
“1. You repeatedly or deliberately submitted false information to the sponsor in a required report [21 CFR 312.70(a)].
Multiple documents contain falsified information. For example:
a. For Subject 010414, the following forms contained fraudulent signatures, which represented that the forms were signed by one of the sub-investigators: Northstar Healthcare form dated 7/29/08, Inclusion Criteria form dated 7/29/08, Exclusion Criteria form dated 7/29/08, Assessment of (b)(4) Illnesses/Events form dated 7/29/08, Medical/Surgical History form dated 7/29/08, Physical Examination form dated 7/29/08, and the report for the EKG performed on 7/29/08.”
The list goes on from there. There really isn’t much to say if the charges can be substantiated. The Blog is unaware of Dr. Berger’s respone, if any. When it does come it will probably come from his attorney.
I’ve actually never seen this charge before (if my poor memory isn’t failing me) and its a pretty big deal. BRI is a large operation and this is not a very good practice, approving studies of your own research institute that is a for-profit enterprise. I discussed the Warning Letter with a colleague familiar with the operations of IRBs who said, “I’ve never seen FDA look into the details of the (IRB) board’s operations before.” And I haven’t seen the Center for Drugs write so many Warning Letters to IRBs before. Very interesting. (See previous post on the Centra and Teneo Warning Letters.)
The Burzynski IRB Chair, Carlton F. Hazlewood, Ph.D., is also a director of the for-profit research institute, raising concerns about conflicts of interest. In fact, “The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest,” is the fourth charge in the Warning Letter. The IRB would also allow non-members to vote if a board member had a conflict. Thats another big problem. There are very specific rules about the membership of an IRB.
The company is run by physician and researcher Stanislaw Burzynski, MD, PhD who has been the President and Chairman of the Board of Directors of the Burzynski Research Institute since its inception in 1984. Read the Warning Letter for yourself. Here is the URL, (WordPress isn’t letting me insert a link):
Up until now it looked like FDA would only go after the sponsor when things went wrong at a clinical site. In the Sanofi Aventis Warning Letter of October 2007 the CRO was mentioned but no Warning Letter followed.
UPDATE: The Warning Letter to ICON was sent out over three months ago and this continues to be the most visited post on this Blog. Obviously many people are interested in CRO oversight. It is an important issue and people involved with clinical research need to know that CROs are doing their job. Here is an article that can assist in reviewing your clinical trial vendors:
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2fSponsor+Articles/Vendor-Quality-Assurance-Audits-A-Formula-for-Succ/ArticleStandard/Article/detail/424921In the J & J Warning Letter the CRO, ICON, was redacted out and you could not determine who the CRO was. It took four months for FDA to write a Warning Letter to ICON. However, now that it is out, it is quite a doozy. FDA states that CROs need to adhere to their regulatory responsibilities. The Warning Letter states, in part:
“FDA regulations require that sponsors, or CROs to whom such responsibilities have been transferred, ensure proper monitoring of clinical investigations. Our investigation found that ICON failed to properly ensure monitoring of the studies referenced above. Inadequate monitoring resulted in deficiencies in recordkeeping with respect to case histories and drug accountability by clinical investigators participating in the above-referenced studies.”
Failure to monitor the progress of the investigation has for years been the number one violation of sponsor responsibilities. Now it appears that FDA is reviewing CROs that have assumed that responsibility. Read the Warning Letter for yourself:
Here is a link to the Applied Clinical Trials online edition for an article written, by the Blogster, on the Diabetes Technology Conference and the “artificial pancreas.” ACT has a new feature on clinical trials for diabetes and other therapeutic areas including podcasts and other high tech features. Read for yourself: