FDA Reports Scam Using Fake FDA Employees

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

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195814.htm

FDA & JAMA Report Device Data Problems

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.

Scam “clinical trial” targets the hard of hearing

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.)