FDA Advisory Panel Urges Strongest Warning for ADHD Drugs

Update March 22 '06: from CTV - FDA Paediatric Advisory Panel recommends tough warnings but not strongest warnings on ADHD drugs.

You gotta' love Americans and American Justice - I mentioned awhile ago that I was going to be sending a submission to the FDA for their ADHD Advisory hearings on February 9th. The decision of the panel was widely reported in these links here.

Here is the FDA's action docket notice from the Drug Safety and Risk Management Advisory Committee to look at cases of sudden death and serious adverse events including hypertension, myocardial infarction, and stroke have been reported to the agency in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult populations. The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks.

I have to commend Canada's CTV for running the decision on their web link. At least someone here in Canada is listening.

The New York Times: A surprising Warning on Stimulants

MSNBC: FDA Drug Advisory on ADHD drugs (with video)

Yahoo: Feds Recommend Warnings on ADHD drugs

USAToday: Warnings advised on ADHD drugs

CTV News: US officials recommend warnings on ADHD drugs

Backgrounder from Alliance for Human Research Protection: Drug Industry sells amphetamine-like drugs

Update: I have learned that my submission didn't make this recent hearing but there will be another docket opened to the public regarding the same topic. The FDA's Pharmaceutical Health Science Administrator confirmed that my submission will be sent to this forum. I am encouraging parents of children who have been diagnosed with ADHD or adults who have been diagnosed to contact the FDA through the above link.

I sent my submission in as a public member because it involved an American company and Canada usually considers doing the same once the FDA has accepted an advisory's recommendations.

I was given the go ahead to send in a submission quite awhile ago. In it, I pointed out in the 10 pages that a psychological testing publisher called IPAT was selling tests that were not approved to test for ADHD in America and was based on American norms were (are?) being sold in Ontario to diagnose for ADHD.

In these instances where these tests were used, not only is ADHD communicated as an "indication" of ADHD (wiggle words for Ontario's medical practitioners so they can get away with mental health diagnosis fraud). The tests were facilitated by a psychometrist running a company called Aptitude Plus that should have been acting under the direction of a psychologist or a psychiatrist to do so. She was not. She was acting under the direction of Human Resources Development Canada - or whatever it is called now.

Here is an excerpt by one of the members of the advisory panel:

"When asked why he and his fellow advisers approved, albeit narrowly, a recommendation they hadn't been asked to consider, Gross said: "No. 1, because of the seriousness of the side effects - the sudden deaths. No. 2,there is a sense maybe the diagnosis of ADHD is being applied where it shouldn't be applied."