ADHD Experts Head to Washington – Is the FDA up to the Task?

Evelyn Pringle March 14, 2006

Heavy-hitters from across the country are heading to Washington this month to debate representatives of the pharmaceutical industry during FDA hearings on the controversy surrounding the over-prescribing of attention deficit drugs to children.

The International Center for the Study of Psychiatry and Psychology (ICSPP) will be represented by five of the leading experts on attention deficit disorders at the FDA’s Pediatric Advisory Committee’s meeting on March 22, to include Dr Fred Baughman, Dr Peter Breggin, Dr S DuBose Ravenel, Dr Grace Jackson, MD, and Dr David Stein. These experts combined have authored hundreds of books, papers and reports on attention deficit disorders.*

And all five have one common goal; to put an end to the drugging for profit of the nation’s most vulnerable citizens and pharma’s most lucrative customer base – innocent children.

Dr Baughman says drugging kids is commonplace today. “Its happening all across country not by thousands but tens of thousands, picking most on the disenfranchized, powerless,” he warns.

“These children become for-profit receptacles for psychiatric drugs,” he says, “which will, undoubtedly alter their bodies and brains.”

The harm caused by these medications is well-documented. Although the FDA staff reports shows 51 deaths between 1999-2003 in persons using ADHD drugs, according to Dr Baughman, the MedWatch database contains 186 deaths between 1990 and 2000. Because only 1% to 10% of all adverse events are reported to the FDA, the actual number of deaths is known to be much higher.

Studies have determined that ADHD drugs endanger the cardiovascular system and according to Dr Jackson, “the cardiovascular risks of stimulants are hardly new.”

“As early as 1977,” she says, “Drs. Vernon Fischer and Hendrick Barner documented the cell changes associated with heart muscle enlargement in a chronic consumer of Ritalin.”

“The connection between stimulants, cardiovascular disability, and death has long been documented in the medical literature,” Dr Jackson notes, “but physicians and government regulators have refused to acknowledge the hazards associated with prescriptions.”

Dr Jackson takes exception with FDA officials who say warnings on ADHD drugs are unnecessary and that their benefits outweigh their risks.

“Whether by ignorance or design,” Dr Jackson states, “the regulators remain oblivious to the evidence-based limitations of the prescription pad: at least 40% of all children fail to tolerate or respond to stimulant therapy; about twice as many respond at least as well to non-pharmacological interventions; and, as documented in the National Institute of Mental Health’s most prestigious study to date (the MTA study), the long term outcomes for medicated children demonstrate diminishing returns over time, persistent suppression of growth (about 1 cm per year), and artificial behavioral improvements which dissipate when treatment is withdrawn.”

“Not surprisingly,” she says, “the world community observes the United States with alarm for the unjustified chemical exploitation of those who are different, but not diseased.”

Dr David Stein also rejects the pill solution, and promotes a parent training program called the caregivers’ skills program that helps children learn appropriate behavioral and cognitive skills permanently, without drugs. For over twenty-five years, he has conducted workshops providing realistic, practical and effective alternatives to stimulant medications.

Dr DuBose Ravenel agrees with Dr Stein’s overall assessment that “this behavioral syndrome likely represents basically a culturally derived phenomenon rather than a biological or neurological one.”

He stresses the importance of providing positive reinforcement for appropriate behavior while dealing with oppositional behavior and encourages fellow professionals to employ Dr Stein’s approach when dealing with children with attention deficit problems.

ADHD drugs are known to have serious adverse psychological effects on children which is one of the main reasons Dr Breggin is dead against giving stimulants to kids. “That we are doing this,” he says, “I believe, is ethically and scientifically wrong.”

“We’re the only country in the world, along with Canada, that is doing this to such massive numbers of our children,” Dr Breggin notes. “It’s a reflection not on our children, but on ourselves as parents and as teachers.”

Dr Breggin describes an all too common occurrence in recent years. “As the child’s emotional control breaks down due to medication effects, mood stabilizers may be added,” he explains. “Eventually, these children end up on four or five psychiatric drugs at once and a diagnosis of bipolar disorder by the age of eight or ten,” he says.

In addition, there is now a mountain of evidence that stimulants disrupt growth hormone production on a daily basis and that they also can reduce the child’s overall growth, including height and weight, according to Dr Breggin.

“All stimulants impair growth,” he notes, “not only by suppressing appetite but also by disrupting growth hormone production.”

“This poses a threat to every organ of the body, including the brain, during the child’s growth,” Dr Breggin warns. “The disruption of neurotransmitter systems adds to this threat.”

“It is hard to imagine a more serious warning flag than growth inhibition,” he says, “since it affects the overall growth of the body and all its organs, including the brain.”

Its a well documented fact that the pharmaceutical industry funnels money to front groups, which in turn fund marketing campaigns and come out to do battle at times like this when drug company profits are threatened and scrutinized.

On February 15, 2006, Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD), the leading Pharma backed front group responsible for pushing ADHD drugs issued a press release criticizing the FDA Advisory Committee’s recommendation last month to add black box warnings to the labels of stimulant drugs.

In the press release, E Clarke Ross, identified as CEO of CHADD stated: “The committee’s recommendation to include warning language about rare and unproven cardiac health risks on medications used to treat ADHD is premature, at best, and could unnecessarily alarm patients and clinicians.”

“The committee,” the press release continued, “directed by the FDA to decide how to move ahead with additional research on the medication’s safety, endorsed future studies, trials and surveys for both pediatric and adult patients.”

Clarke said the committee “approved the unsolicited recommendation to include warning language on patient inserts and labels.”

On March 13, 2006, the Shreveport Times published an article by Terry Davis, that seems to directly address the issue raised by CHADD, which began with the question: “Do drugs used to treat attention deficit hyperactivity disorder need a black box warning because of reports that they may cause sudden death?”

Ms Davis was a member of the FDA advisory committee that decided last month that they did. In the article she explains the reasoning behind the decision.

“The panel felt the parents of the 2.5 million children taking medication such as Ritalin or Adderall – the 1.5 million adults also on these medicines, as well as their physicians – need to be alerted about the drugs’ significant risks,” she wrote.

“The advisory panel was also concerned that ADHD drugs are overused,” she said and noted that more than “30 million prescriptions – valued at $3.1 billion – are filled annually.”

“ADHD medications help,” Ms Davis acknowledged, “however, they are also known to increase blood pressure and heart rate and may increase risk of stroke and arrhythmia in adults,” she said.

She pointed out that last year, “25 people, mostly children, died suddenly after taking these prescribed drugs.”

In light of this logical explanation, CHADD’s criticism of the panel’s recommendation is obviously unwarranted but hardly surprising.

The group bills itself as the nation’s largest patient education group for persons affected by ADHD, and says it provides consumer, patient, and professional information. But those familiar with the marketing tactics of ADHD drugs know all about CHADD’s long history of concerted effort to increase drug company profits through the sales of stimulants.

According to Dr Baughman, as far back as 1995, the DEA was contacted by the United Nations International Narcotics Control Board (INCB), about the financial ties between CHADD and Ciba-Geigy, the manufacturer of Ritalin at the time.

The INCB discovered CHADD had received over $775,000 from Ciba-Geigy and charged the organization with being a vehicle for marketing a controlled substance to the public in violation of the international statute known as the Controlled Substances Act of 1971.

Ritalin is classified as a Schedule II medication. In order for a product to be classified as a Schedule II drug under the Federal Controlled Substances Act, it must meet three criteria: one, it has to have a high potential for abuse; two, it has to have a currently accepted medical use in treatment in the US; and three, it has to show that abuse may lead to severe psychological or physical dependence.

It seems CHADD was lobbying the Drug Enforcement Agency to get Ritalin removed from the Schedule II class and moved into a less controlled group to make the drug easier to buy.

“They couldn’t do anything more valuable for the drug company, and more dangerous to the public,” according to Dr Baughman.

However, it’s lobbying failed, in part because of the disclosure about CHADD receiving so much money from the drug companies, according to Dr Breggin.

After conducting its own research, the DEA not only refused to reclassify the drug, on May 16, 2000, the agency issued a report to Congress that said Ritalin use had reached epidemic proportions, and that it was being abused as a recreational drug.

DEA told Congress that police were reporting that Ritalin was being stolen, sold and traded on playgrounds, as well as snorted, injected, and cut much like any other amphetamine. Although the DEA presented a thorough report, nothing was done to slow the sale of Ritalin to children.

And nothing changed as far as CHADD’s employment status as a major pusher for Pharma either. For the fiscal year 2002-2003, the group’s financial statements showed it received more than $670,000 from various drug companies.

In the November 29, 2004 Alternet article “Drug Companies Pushing ADHD Drugs for Children,” reporter Kelly Hearn further discussed the ties between CHADD and the drug companies in an interview with Dr William Pelham, director of the Center for Children and Families at State University of New York at Buffalo, a leading ADHD researcher for 30 years, and a former advisory board member of McNeil Pharmaceuticals, which markets the ADHD drug Concerta.

Over his career, Dr Pelham has written more than 250 research papers on ADHD, and in 2002, he even received a lifetime achievement award from CHADD.

However, he has few good words to say about CHADD, regulatory officials, medical professionals, or anybody else involved in selling ADHD drugs to children.

“In recent years,” Dr Pelham told Alternet, “I have come to believe that the individuals who advocate most strongly in favor of medication – both those from the professional community, including the National Institutes of Mental Health, and those from advocacy groups, including CHADD – have major and undisclosed conflicts of interest with the pharmaceutical companies that deal with ADHD products.”

“I believe that parents of ADHD children and the public at large should be made aware of this situation,” he told Ms Hearn.

According to Dr Breggin, front groups like CHADD use pharma money in several marketing techniques that increase the sale of drugs. “They put out newsletters and other information that praise medications,” he says.

“Sometimes,” he notes, “they actively suppress viewpoints that are critical of drugs – for example, by discouraging the media from airing opposing viewpoints.”

Representatives of CHADD showed up at the FDA hearings last month and the group will no doubt be out in full force this month ready to go head to head against pharma’s number one enemy – the advocacy groups opposed to the mass drugging of children for profit.

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