FDA and ADHD Stimulant Medication. Science or Stigma? Part 1

What a dog and pony show.

First the FDA has a committee that did a report in Feb 2006 that calls for a black box warning for ADD stimulant meds by an 8 to 7 margin over concerns that stimulants may be linked to heart problems in kids. Unfortunately they provided no evidence that showed that people who take ADD stimulant medication have a higher degree of cardiac problems vs. what’s called the background rate, namely, what’s the incidence of the same problem in the general population.

Health Canada pulled Adderall XL last summer because of concerns over cardiac problems.

Problem was

1. The data was based on US not Canadian data.

2. “The U.S. Food and Drug Administration reviewed the data on the cases last summer and concluded the rate of sudden deaths and strokes in Adderall users wasn’t higher than what’s called the background rate — the rate of such events that would be expected to occur in people not taking the drug. ”

3. ” Top Canadian ADD researchers on ADD told me last June that they weren’t consulted before the drug was pulled and didn’t think it should have been pulled.”

Later they reinstated Adderall XR and announced a media press conference the same day as the announcement, interesting timing.

This looks like the Adderall screw up all over again. The FDA provided NO data showing that ADD stimulant medication caused cardiac problems at a higher rate than in the general population.

Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, told fellow committee members they should recommend the black box warning. Nissen said his suggestion was meant partly to slow what he characterized as the “out of control growth” use of the drugs.

The drugs already carry warnings related to the possible risk they could pose to patients with heart defects.

They’ve known about this for 30 years. This is not new information.

A New York Times editorial said this of the move

some FDA officials and psychiatrists were concerned the recommendation would “scare people away from potentially beneficial therapy” if the panel “issue[d] too strong a warning based on uncertain evidence.” However, the editorial says, “The prime function of a strong warning label is to force doctors to think twice before prescribing,” and “that is presumably salutary even if it does depress drug sales a bit.” The editorial concludes, “The renegade advisory panel was right to throw its weight against this trend” (New York Times, 2/12).

So basically the recommendation wasn’t based on scientific evidence, or the truth. It looked like the recommendation was based on an ideological belief. So they’re playing politics with our lives and well being.

Unfortunately, I’ve heard more than a few stories by some individual who went to a doctor to see if they had ADHD and instead of getting a proper diagnosis, they (according to what they told me) were told take this Ritalin and if it works you have ADD. I’m pretty sure that this ignorance and incompetence is the exception rather than the rule.

But instead of putting a false label on a group of medications, the government should make sure that doctors, psychologist and psychiatrists are

A) Adequately trained on how to diagnose ADHD and associated or comorbid conditions (depression, anxiety, OCD, Bipolar etc)

B) Adequately paid for their time to do so. In Vancouver where I live a doctor only gets paid for seeing a patient for 15 minutes. You can’t diagnose ADHD in 15 minutes. I’ve talked to a few doctors at the CADDRA Vancouver ADHD conference last summer, who were able to diagnose ADHD and I asked them if they wanted to be on my list of people known to diagnose and treat ADHD in the Vancouver area. They said no, because they lost money doing so. I wonder if it’s the same in other areas of Canada and the US?

Thomas Laughren, director of the FDA’s division of psychiatry products, says it would be unusual for the agency to issue a “black box” warning based on such thin evidence. He notes that the reported number of sudden deaths in patients taking stimulants is lower than the figure that experts would expect to see among people who aren’t taking the drugs. A second FDA committee, which focuses on pediatrics, will consider the drugs’ safety next month, Laughren says.

via Psych Central

I think the real problem is that medical professionals who are not adequately trained and paid to diagnose ADHD, and people who have or might have ADHD are getting screwed by this and no one is asking why this is not being taken care of. I guess it’s because those beating their chests against the drug companies (no paragons of virtue themselves) don’t really care about those of us with ADHD, they just want to feel self righteous.