FDA Hearings On ADHD Drugs Will Sound Like A Broken Record

Every few years one government entity or another pretends to be concerned about the fact that pharma is drugging the nation’s children with stimulants. Whether it be the FDA, or a congressional committee, the sequence of events is always the same. They hold hearings and appear shocked as they listen attentively to the upset parents and advocates who show up to speak on behalf of innocent children. But as soon as the hearings are over, drug companies carry on business as usual.

In reviewing the transcripts from the past 5 years of hearings, the testimony sounds like a broken record – the same information gets rehashed over and over and over. The same dedicated advocates show up to testify about the latest statistics and horror stories while members of the panels pretend to be shocked, just shocked, as if its the first time they’ve ever heard any of it.

The FDA is running the charade this year. Its advisory committees held two hearings last month and two different advisory panels have scheduled hearings for March 22, and 23. Of course true to form the advisory panels are stacked with pharma connected members.

But the outcome of the hearings will change nothing one way or the other. Even if the FDA does order the dreaded black box warning on the labels of ADHD drugs, pharma will continue to find doctors who will prescribe the drugs regardless.

As it stands right now, the off-label use of stimulants with pre-school children is rampant even though no ADHD drug has been approved for children under 5.

By now, what more can be said at hearings? What new news is there to report?

Back in May 2000, Deputy Director Terry Woodworth of the Federal Drug Enforcement Administration told Congress that although his agency could not estimate overall numbers on the use of ADHD medications, drug production indicated the numbers were soaring.

Between 1991 and 2001, he said, the number of prescriptions had increased almost 500%, and Ritalin production had gone from less than 2,000 kilograms in 1990 to almost 15,000 kilograms in 2000.

In May 2001, the Archives of Pediatrics and Adolescent Medicine published a study of North Carolina’s Medicaid program that found the use of drugs such as Ritalin and Adderall, had increased by nearly 550% between 1992 and 1998. In 1992, there were 24,584 prescriptions written compared with 135,057 prescriptions in 1998.

On April 15, 2004 CNN, reported that an estimated six million children in the US were taking Ritalin every day, up 500% since 1990.

So what has changed between 2000 and 2006? Is there a different way to present these statistics?

The drugging of toddlers has been reported for over a decade. A study published in the February 2000, New England Journal of Medicine, by the University of Maryland, estimated that 150,000 preschoolers (10% were 2-year-olds) were on psychotropic drugs in 1995, up from 100,000 only four years earlier.

A report published back in the October 1999 Archives of Pediatrics and Adolescent Medicine, on a study from Michigan State University in Lansing, warned that children three and under were being diagnosed with ADHD and placed on drugs.

The study reviewed the medical records on 223 Michigan children on Medicaid who had been diagnosed with ADHD at or before the age or 3 and determined than 25% of the children had been diagnosed at or before the age of 2.

The study found 57% of the children were put on drugs but psychological treatment was only provided to 27% of the kids.

The most frequently prescribed drugs were Ritalin and clonidine, even though studies dating as far back as 1995 found this combination to be lethal and reported four sudden deaths due to cardiac complications in children taking clonidine and methylphenidate together (Swanson et al. 1995; Cantwell et al. 1997; Fenichel 1995).

But it gets worse. Over one third of children in the Michigan study were on 2 or three psychotropic drugs at the same time, involving 30 different combinations and almost half were on two to six different drugs over time.

The authors of the report pointed out that most of the drugs used had never been tested for safety or efficacy in young children either alone or combined. "[T]he extreme variation in the use of psychotropic medications suggests haphazard use at worst and uninformed use at best." the report said.

At a September 26, 2002, Committee on Government Reform hearing on the Overmedication of Hyperactive Children, in regard to Ritalin, Representative John Duncan claimed, "I have to believe that this drug is way overprescribed in this country."

"And I believe it’s all really about money," he added.

He read from a June 28, 1999 article, titled "Doping Kids," that estimated that Novartis generated an increase in stock market value of $1,236 per child prescribed Ritalin.

"Based on these evaluations, the drug company would have enjoyed an increased stock market value of approximately $10 billion or more since ’91," he noted.

"I’ve known personally two or three of these young boys that have been put on Ritalin," Rep Duncan continued. "And they have appeared to me to be in zombie-like states," he observed.

"I believe it’s being overprescribed in this country just because of the profit factor," he noted, "the money that’s out there that the drug companies want to make."

Representative Dan Burton said the committee heard reports that Ritalin was being prescribed for 2-year olds in the Medicaid population and asked Dr Mary Ann Block, author of the book, "No More ADHD", whether she had any idea how physicians are influenced by the drug companies to prescribe ADHD drugs for kids.

"Yes, as a physician, I see this influence all the time," she told Rep Burton.

"For one thing," she said, "I don’t think any of us can turn on the television, radio, open up a newspaper or magazine without seeing multiple advertisements for prescription drugs."

"They go so far as to say, "Ask your doctor if this drug is right for you," she continued, "encouraging the public to go to the doctor to get a drug."

"But in addition," she noted, "I don’t believe the public is aware of the strong influence the pharmaceutical industry has on physicians."

"From the time we start medical school until the day we stop our practice," Dr Block continued, "we are strongly influenced or attempted to be strongly influenced by the pharmaceutical industry."

"Our medical journals," she said, "which are purported to be unbiased, usually have about 60 percent of their pages as full-page ads from the pharmaceutical industry."

"If I go to a continuing medical education meeting," she noted, "the doctors who are talking to us are being paid by the pharmaceutical industry to give those lectures."

"Many doctors are being paid in their offices to do research for the pharmaceutical industries as well," Dr Block told he panel.

"They also give money to different groups who go out and promote the use of these drugs for our children," she noted.

"So the pharmaceutical companies have a tremendous influence on our society and especially on physicians," she said.

This congressional committee clearly knew the score in 2002 and yet here we are four years later getting ready to play the same broken record at more government hearings.

And while doctors continue to claim the increase in cases of ADHD is due to "better diagnoses," it seems rather odd that the only change in treatment for the disorder has been the ever-rising number of new drugs competing for the lucrative market.