FDA and ADHD Stimulant Medication. Science or Stigma? Part 2

See Also Part 1

Federal health advisers said Wednesday that Ritalin and other drugs for attention deficit hyperactivity disorder should not carry strong ”black-box” warnings about potential cardiovascular and psychiatric risks.

Rather, the Food and Drug Administration pediatric advisory committee recommended that the drug labels include warning language written so people can understand it.

Looks like the FDA is likely to follow the advice of committee #2

”I think we are likely to follow them, yes,” said Dr. Robert Temple, director of the FDA’s office of medical policy, following the meeting.

About time.

A black box warning is the toughest warning there is for a drug. You shouldn’t be putting it there unless there is real evidence that people who use drug X will have a higher incidence of problem Y than people in the general population. Which is not the case here.

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.

Dr. Ed Hallowell author of 2 books on ADHD says in a LA Times commentary that he

feverishly read the official statements, looking for the terrible new data that justified this recommendation. But there was none.

He mentioned that stimulants have been used for nearly 70 years, and used properly they have proved safe and effective.

I think the FDA panel reacted so strongly because so many people are being put on stimulants that it is hard to believe a proper work-up is being done on each of them. This objection makes more sense. Most primary care doctors don’t have enough time to do the in-depth work-up a diagnosis of ADD requires. Some doctors are writing too many prescriptions for stimulants; others refuse to write any at all. Most neglect to offer treatments that do not involve medication. Stimulants are not always effective or necessary…

Therefore, every treatment for ADD should include a program aimed at identifying and promoting talents and interests, whatever they might be. Viewing ADD only as a disorder creates far worse disorders: shame, loss of hope and giving up on dreams. That’s what really deserves a black box warning.

One thing that people aren’t mentioning is many media mentions of this whole issue often only talk about children with ADHD, not adults with ADHD. We’re the missing part of the equation. I watched the CBC news show The National a few nights ago (CBC is like ABC/NBC/CBS with a bit less hysteria) and Wendy Mesley the stand in anchor only mentioned children with ADHD not adults. Maybe adults with ADHD should start calling and emailing their media when this happens so we’re not so damned invisible.

I’m tired of getting calls from people who think they might have ADHD and talk to their doctor/psychiatrist/psychologist about them possibly having ADHD and getting the response “oh you can’t have ADHD, that’s only for children” or “oh you can’t have ADHD, you did well in school and have a good job”. Tell them about the Mensa ADHD group with 337 members, or the two Billionares with ADHD. I know there are competent knowledgeable medical professionals who can and do adequately diagnose and treat ADHD, I just think there’s not enough of them based on what I hear in person, on the phone, in emails and in talks with other ADHD professionals.

I think that people with ADHD especially adults with ADHD should start getting more politically active and start demanding adequate diagnosis and treatment instead of continually tolerating far too much second class medical treatment. No one will do the work for us, no one will contact the media, politicians or medical unions and bureaucracies. We need to do it ourselves. If you think you’re too busy or too overloaded/disorganized to do it, don’t complain when you can’t get adequate treatment for yourselves or your children, or someone needlessly takes away the one ADD med that works for you.