The FDA’s Drug Safety & Risk Management Advisory Committee held a two-day meeting last month on February 9th and 10th to review adverse events linked to the widely prescribed ADHD drugs that included reports of sudden death, high blood pressure, heart attacks and strokes among adults and children taking the medications.
In the US, between 1999 through 2003, the FDA had reports of 24 deaths among patients who took the amphetamine, Adderall, the staff report said. Eleven more deaths were reported among patients using other drugs in the amphetamine class, it noted.
During the same time frame, another 16 deaths were reported in patients who took Ritalin or other drugs known as methylphenidates, the report stated.
Thirty additional deaths of methylphenidate patients were recorded but they were either non-US cases or occurred outside the review period, the FDA said. The agency also excluded cases that appeared linked to intoxication from multiple drugs or other causes.
During the February hearings, the committee heard testimony by representatives from several advocacy groups, as well as medical professionals and other interested parties, basically advocating for or against the use of ADHD drugs with children.
Sue Parry from New Mexico appeared and told the panel that she had traveled to the hearing at my own expense because she was concerned about the safety of the stimulant drugs given to children, some as young as two years old, she noted.
“I have worked as a school-based occupational therapist with students, mostly boys,” Ms Parry said, “who supposedly had ADHD.”
“I am also the mother of three sons who a decade ago,” she said, “like many young boys in America, were at risk of being labeled ADHD.”
She advised the panel that parents are not aware of the future harm that may result from an ADHD diagnosis, as eloquently described by Dr. William Carey who states:
“”The label may be stigmatizing and harmful in the long term in ways that are only dimply appreciated today. The diagnosis of brain malfunction, which seems so useful and comforting today, may at a later time come back to plague the person. We have not yet had sufficient time to observe fully the possible consequences it may have for education opportunities, employment, the military service or security clearances. Labels stick firmly, especially when they involve neurological disability.”
Ms Parry said parents are also not told that the 1998 ADHD Consensus Development Conference statement reads: “However, we do not have an independent, valid test for ADHD, and there are no data to indicate that ADHD is due to a brain malfunction.”
“The ADHD epidemic is a disgrace,” she told the audience.
“Our nation’s children do not need more federal studies,” she continued. “What they need is a federal grand jury to investigate what may be the biggest healthcare fraud our nation has ever seen,” she advised.
“Is the ADHD epidemic about neurotransmitters and chemical imbalances,” she asked the panel, “or is it about increased market share for drug companies?”
“Have our kids simply become funding mechanisms to be screened, labeled and medicated?” she asked.
“Only one government agency,” Ms Parry pointed out, “the DEA’s Office of Diversion Control, has stood up to this psychopharmaceutical cartel.””
Allen Jones, appeared on at the hearing on behalf of the Alliance for Human Research Protection, and started his testimony by saying, "I look at this panel and I am troubled."
"Most of you have had past or current relationships with the drug industry," he continued.
"I spent time researching these relationships," he informed the panel.
Mr Jones said he wondered how many people in the audience knew that Dr Elizabeth Andrews, "who spoke earlier, is a past world vice president of GlaxoSmithKline?"
Then he said he wondered how many knew that "Dr. Manasse heads an organization that takes in millions of dollars from the pharmaceutical industry?"
"These things were not, to my knowledge, disclosed," he said.
According to Mr Jones, the adverse events caused by ADHD drugs are readily apparent in hospital emergency rooms, case reports in the medical literature and doctors’ offices around the country, and the reporting of regulatory agencies in other countries.
"Pharmaceutical marketing in the United States seems to have far outstripped the willingness of the FDA to track adverse events," he told the audience.
"There is urgency in this present situation," he said. “Millions of Americans who are unaware of the dangers are taking drugs that threaten their lives,” he advised.
Mr Jones asked the panel to take immediate action to make the medical community and citizens aware of the risks. "We cannot rely on future clinical trials to save the persons who are at risk today," he warned.
Dr Chris Griffith appeared at the hearing as a representative of the group, Children and Adults with ADHD, better known as CHADD, the notorious industry funded front group responsible for promoting the sale of ADHD drugs.
According to Dr Chris, "the medications used for treatment of ADHD are safe and very effective."
While testifying, she painted a dire picture of children who will probably burn in hell if deprived of ADHD drugs. "What happens when a child loses all hope and ambition;" she asked, "what happens when it is easier to find a vial of crack cocaine or 40 ounces of beer as opposed to a park or community recreation center?"
And it gets worse according to the good doctor. She asked the audience to think about:
"What happens to a future generation of minority youth, African-American, Latino males who disproportionately populate our juvenile justice system? What happens to a teenager’s sense of fun when we are dealing with high rates of teen pregnancy, sexually transmitted diseases and even abortions?
"Finally, what does it say about all of us? We turn on the news each night and we tragically see young drivers, teenagers, killed in automobile accidents–so many that we forget their names, their faces and their stories. We develop a sense of apathy."
"This may all seem like drama," she told the audience. "Unfortunately, it is the untold story of what happens when we fail to recognize and treat ADHD," she said.
According to the doc, depriving kids of what amounts to legalized speed, leads to every misbehavior and sin known to mankind:
"With untreated ADHD we see higher rates of school and occupational failure; greater rates of incarceration; juvenile delinquency; substance abuse; teen pregnancy; sexually transmitted diseases; more problems with depression and self esteem and, finally, greater numbers of automobile accidents and fatalities."
Its a drama all right, but the good doctor has it backwards. Kids who are fed speed from age 2 on up are the ones likely to end up in the situations described above.
"Children who are medicated early," Psychiatrist Dr Stefan Kruszewski warns, "can’t adapt or learn to find coping strategies that work for them as they move through different developmental stages."
"Instead," he explains, "they learn to rely on a psychopharmaceutical behavior, i.e., that drugs can solve problems, rather than their innate creative potential to solve problems by themselves or with the help of family, friends, schooling, music and the arts, church, social outings, recreation and sports."
Actually, aside from the cheerleading by CHADD, the only good news that came out at the hearing for pharma was when Dr Kate Gelperin stated: "Drug treatment of ADHD is increasing in all age groups … and also drug treatment for ADHD can now potentially be life-long." That remark definitely describes a customer base that drug companies have been chasing after for years.
Dr Kruszewski says, "one of the problems with the diagnostic assessment of ADHD, is that a pre-screening statement is so inclusive that virtually every child meets pre-screening criteria and therefore every child, under prevailing treatment modalities for ADHD, becomes eligible for ‘chronic’ medication therapies."
Dr Kruszewski says once screened, "children become ‘eligible’ for further screening for co-morbid conditions (social anxiety, bipolar disorder, obsessive-compulsive disorder, etc) and therefore eligible for the possibility of even more medications."
Thus, an ADHD diagnosis marks the beginning of a nightmare for many kids.
Sandra Lucas appeared at the hearing and testified on behalf of the Citizens Commission on Human Rights, a psychiatric watchdog group.
Ms Lucas told the audience, “we do know that the side effects of the stimulants are not only present, they are extremely serious and sometimes lethal.”
“So, while the FDA ponders the problem of studying the issue and conducting the studies that may have inherent flaws,” she said, “what real, immediate protections are to be put in place for parents and children?
“If anyone proposed to study the issue of giving cocaine to children to suppress symptoms of inattention, that individual would be regarded as off his rocker,”” Ms Lucas said.
“Yet,” she continued, “there is already ample evidence that stimulant drugs given to children are similar in their effects to cocaine, the major difference being, of course, that cocaine is illegal, that drug companies do not profit from it, while stimulants are legal and highly profitable.”
Ms Lucas also noted the conflicts of interest between several members of the panels that were exposed. “In fact,” she said, “I can think of one member from previous committees who was so beholden to the drug companies that one might liken his presence to any hearings to inviting Osam bin-Laden to a national security meeting.”
After listening to all the testimony, the Drug Safety panel voted to recommend that ADHD stimulant drugs carry a black box warning alerting patients and doctors about potential cardiovascular risks.
Panel member, Dr Steve Nissen said he was certain the public was not aware of the risks. "If the current warnings were adequate we wouldn’t have 2.5 million children and 1.5 million adults taking these drugs," he noted.
"I mean," he continued, "it is just self-evident to me that the exponential growth in the use of the drugs suggests that the public and practitioners are unaware that there are people sitting around this table that have a serious concern about the safety."
Dr Nissen also said he was not very confident about the number of adverse events in the spontaneous reporting system. "We know that you get 1-10 percent of the actual events reported," he said.
Dr Nissen is correct. The number of deaths cited at the hearing does not portray an accurate picture. There were more deaths of children linked to ADHD drugs recorded by individual states than were reported for the whole country at the hearing.
For instance in Florida, the report, “Child Suicides In Florida Associated With Use Of Psychotropic Drugs,” by researcher Ken Kramer, recently released after a year long investigation, found that out of the 252 cases of suicide in children under 18, between 2000 and 2004, thirty-six of the children who committed suicide were on ADHD drugs.
As far as diagnosing attention deficit disorder, FDA official Dr Andrew Mosholder told the committee: "The etiology is unknown."
"Environmental, genetic, developmental and familial factors are all thought to play a role," he said. "The diagnosis is clinical."
But most importantly Dr Mosholder explained what experts believe all parents deserve to know. "There are no pathognomonic physical or laboratory findings," he said, "and there is no psychological testing that can make the diagnosis for certain."
