Dan Jenski – ADDicted

Kickstarter is a website for artists to use to raise money and complete awesome projects. The best thing to come to the informed consent movement since Thomas Szasz could just be the new, upcoming film by Dan Jenski, “ADDicted” which basically gives Ritalin, Adderall, Concerta and the like a great big gigantic middle finger. Dan is a friend of mine and I see huge potential in his work. I’m thinking Oscar. The short film version of ADDicted has made it into film festivals all across the country and now Dan and his co-producer Aaron Bickes need to raise enough money to be able to create the feature length film.

With fewer and fewer days left in this important campaign, you can make a difference today for future generations of children, high school, college, and graduate students BEFORE their moms, teachers, dads and doctors get a chance to diagnose them with some kind of problem leading to the use of risky and damaging, potentially fatal stimulants. This project needs donations. Please help us spread the word.

Check it out at http://www.kickstarter.com/projects/libproductions/addicted-feature-film?ref=live

Also read what award-winning writer Kelly O’Meara has to say about it here:


Biggest Off-Label Drug Marketing Scheme in History – Part II

Evelyn Pringle December 1, 2006

In fairness to off-label prescribing doctors, until recently, studies that showed SSRIs were ineffective and dangerous when used by children were kept hidden and thus, the data made available to physicians painted a rosy, but false, picture of success with SSRIs.

And up until recently, many doctors were not even aware that their fellow doctors who were encouraging the use of these drugs for off-label indications at medical education seminars were being paid by SSRI makers to give the presentation.

However, there is no longer any excuse for peddling SSRIs to children. Since the actual studies became public, British authorities have told doctors to never prescribe SSRIs to children without first trying multiple alternatives and psychotherapy and to never prescribe Paxil and Effexor to depressed children under any circumstances.

A review of all of the studies which led to the ban, was conducted by Tim Kendall, deputy director of the Royal College of Psychiatrists’ Research Unit in London, and colleagues, and discussed in the April 23, 2004, New Scientist journal.

In his position, one of Mr Kendall’s duties in the UK is to analyze research to draw up the clinical guidelines on which the British government bases its drug regulations much like FDA does in this country.

After revelations about the existence of hidden pediatric studies, Mr Kendall contacted the drug makers directly requesting the unpublished studies and when none of them complied, he contacted a government agency which provided 6 unpublished studies on 3 SSRIs.

His research team then added those results to a review of 5 published studies on the effects of SSRIs on children and the tables turned. “When we got the unpublished data and put it in with the published data, something happened,” Mr Kendal told New Scientist. “Instead of being safe and effective, the risk-benefit reversed.”

For instance, the unpublished studies on Zoloft, New Scientist said, “suggested the drug increased suicide-related events such as suicidal thoughts or attempts by 14 times compared with placebo.”

And the review of the studies revealed no benefits in the pediatric use of SSRIs. “This data confirms what we found in adults with mild to moderate depression: SSRIs are no better than placebo,” Mr Kendall said, “and there is no point in using something that increases the risk of suicide.”

An editorial in the journal, Lancet, which published Mr Kendall’s study, said the research on SSRIs in children was marked by “confusion, manipulation, and institutional failure.”

Analyses of published studies that governments rely on to set regulations, it stated, are “made entirely redundant if results are so easily manipulated by those with potentially massive financial gains.”

The editorial also pointed out that GlaxoSmithKline sold almost $5 billion worth of Paxil in 2003, even though in June 2003, Paxil was found to increase suicidal thoughts and behavior in children by as much as 3-fold compared to children on a placebo.

The off-label prescribing of atypicals is every bit as rampant as with SSRIs. On March 16, 2006, the Associated Press reported that soaring “numbers of American children are being prescribed anti-psychotic drugs — in many cases, for attention deficit disorder or other behavioral problems for which these medications have not been proven to work,” citing a study led by Dr William Cooper, a pediatrician at Vanderbilt Children’s Hospital.

Between 1995 and 2002, the number of children covered by Medicaid and prescribed antipsychotics jumped 5-fold, to an estimated 2.5 million, the study said, or an increase from 8.6 children for every 1,000, to nearly 40 out of every 1,000 in 2002. “The increasing use of anti-psychotics,” the Associated Press wrote, “corresponds with the introduction of costly and heavily marketed medications such as Zyprexa and Risperdal.”

But the over-prescribing is not limited to kids on Medicaid. On May 11, 2006, the Associated Press reported that the use of atypicals by privately insured persons 19 and under had skyrocketed 80% in the four years ending in 2005, citing a report by Medco Health Solutions based on an analysis of over 2 million insured Americans.

The package inserts for these drugs specifically state that their safety and effectiveness have not been established with children and they come with no dosage recommendations for children even though experts say dosage issues have a higher importance when prescribing drugs to children because of their differing weights and developing bodies.

Doctors all over the country are prescribing psychiatric drugs in combination with one another for uses that have never been tested in any patient population. Medical professionals say its not uncommon to see patients, including very young children, on an SSRI, an atypical, an ADHD stimulant drug, and a sleeping medication all at the same time.

In fact, according to a study conducted by Medco Health Solutions, a managed-care firm, there has even been an 85% increase in the use of sleeping pills by children and young adults between 2002 and 2004.

New York Times reporter, Gardiner Harris, published an article on November 23, 2006, discussing the prescribing of off-label combinations of psychiatric drugs to children. For the article, he interviewed Andrew and Leslie Darr of Caldwell, Idaho, whose 2 sons were prescribed several psychiatric medications at the same time.

Mr Darr said that he was opposed to the drugging from the start. “When you come home from work and instead of getting them clawing at your feet and yelling, ‘Daddy, Daddy,’ you get a lethargic grunt, it just kills you,” he told Mr Harris.

Mrs Darr said that she was pressured by school officials to give her son Nicholas a stimulant drug when he was 6, and that his brother Nathan, a year younger, soon followed.

Three years later, the boys had a traumatic experience, and a month after that, both boys were hospitalized and given a diagnosis of bipolar disorder, with prescriptions for an antipsychotic, an antidepressant and a sleeping medication.

Atypical drugs are known for causing drastic weight gain. In three years, Mr Harris reports, Nicholas’s weight ballooned from 52 pounds to 140, and Nathan went from 48 pounds to 115. Neither boy got much taller, Mrs Darr told Mr Harris, and they both did poorly in school.

When another child in the family became ill, a nurse practitioner gave Mrs Darr free samples of an antipsychotic “to help her cope.” After she began taking the drug, Mrs Darr said, she could not sleep or think straight and realized that she had been giving similar drugs to her sons for years and decided to wean them off the pills.

After the boys were off all medication for four months, their behavior normalized, the Darrs told Mr Harris, and they were transferred out of special ed into regular classrooms.

In an interview for the Times, Nicholas said the drugs “were not cool.”

“You go to school and everybody thinks, ‘Look at that retard,'” he told Mr Harris.

On October 8, 2006, California child and adolescent psychiatrist, Dr Elizabeth Roberts, author of, “Should You Medicate Your Child’s Mind?” who has worked with children for more than 30 years, published an opinion piece in the Washington Post, and said, “the changes I have seen in the practice of child psychiatry are shocking.”

“There has been a staggering jump,” she notes, “in the percentage of children diagnosed with a mental illness and treated with psychiatric medications.”

“There was a time,” Dr Robert writes, “when doctors insisted on hours of evaluation of a child before making a diagnosis or prescribing a medication.”

Today, she says, some of her colleagues brag that they can make an assessment and write a prescription in less than 20 minutes and some parents have told her that it took their pediatrician only 5 minutes.

Dr Roberts says the loser in this race is the child “who must endure the side effects of these powerful drugs and be burdened unnecessarily with the label of a mental illness.”

“Parents and teachers today,” she says, “seem to believe that any boy who wriggles in his seat and willfully defies his teacher’s rules has ADHD.”

“Likewise,” she notes, “any child who has a temper tantrum is diagnosed with bipolar disorder.”

“Psychiatrists are now misdiagnosing and overmedicating children for ordinary defiance and misbehavior,” she writes in her editorial. “The temper tantrums of belligerent children,” she says, “are increasingly being characterized as psychiatric illnesses.”

“Using such diagnoses,” Dr Roberts states, “doctors are justifying the sedation of difficult kids with powerful psychiatric drugs that may have serious, permanent or even lethal side effects.”

But the off-label over-prescribing of atypicals is happening with all age groups. A June 2005, study in the Archives of Internal Medicine reviewed nearly 2.5 million Medicaid beneficiaries in nursing homes and found that more than 200,000 residents received antipsychotics that had “no appropriate indications for use.”

A study conducted at the University of Georgia in the June 2006, Journal of Clinical Psychiatry, reviewed prescribing records for 107,000 Medicaid recipients on drugs that act on the central nervous system and found that 75% of SSRI patients and 64% of atypical patients received at least one of these drugs for an off-label use, and most of the time without the patient’s knowledge.

However, life in the fast lane for the doctors whose off-label prescribing habits have increased due to the influence of Big Pharma without the knowledge of their patients, may soon find themselves sitting at the same table in a courtroom with the drug maker defendants, legal analysts say.

Although no law in any state specifically requires doctors to tell their patients when a drug is prescribed off-label, in some states like California, judges may now allow injured patients to use a doctor’s lack of disclosure to bolster a malpractice suit, according to the May 5, 2006 San Francisco Chronicle.

California law does not explicitly require doctors to reveal that they are prescribing a drug off-label, the Chronicle says, but a jury might conclude on its own that the patient needed that information to make an informed choice. “If a jury reached that conclusion,” it states, “the liability could be increased for a physician who didn’t disclose the drug’s off-label status.”

Attorney, Barry Turner, Lecturer in Law at Leeds Law School in the UK is an academic lawyer who has been involved in litigation related to the off-label marketing and promotion activities involving Big Pharma for several years.

He says combing drugs, or polypharmacy, can be a dangerous practice for doctors even in general medicine. But at least in cases like diabetes or heart disease, he says, cause and etiolgy are often known and understood, making decisions about the risks and benefits of multiple medications possible.

“That knowledge is totally absent in psychiatry,” Mr Turner reports. “While the data on efficacy of multiple medications is ‘zero – zip’,” he says, “the data on side effects and adverse drug reactions is not.”

“Polypharmacy, based on hit and miss ‘diagnosis’, guesswork and belief systems rather than science,” he warns, “is dangerous hokum and a ripe territory for negligence actions.”

States are beginning to come down on doctors for the off-label prescribing bills submitted to Medicaid. In August 16, 2006, the Houston Chronicle reported that 5 Texas doctors who treat children covered by Medicaid were instructed to return $11,034.43 to the state that was paid out for psychiatric drugs they prescribed.

Two years ago, state officials did a two-month review of Medicaid payments for psychiatric drugs prescribed to Texas children and found that 63,118 children were on stimulants, SSRIs, or antipsychotics, with nearly one-third taking drugs from more than one of those classes. During that 2 month period, review identified 114,315 claims worth more than $17 million just for kids alone, according to the Chronicle.

Texas has since established strict guidelines as far as prescribing psychiatric drugs to children and doctors have been warned of the consequences of off-label over-prescribing.

On September 13, 2006, the American Statesman reported that the Texas Medical Board suspended the license of a psychiatrist for improperly medicated a 7-year-old boy with Prozac and the ADHD drug Stattera, and causing him to be hospitalized with homicidal and suicidal thoughts.

The doctor had also mishandled the care of another patient who overdosed on drugs that he prescribed, the Board found.

The responsibility for ending the most blatant off-label marketing scheme in history should not be left up to the individual states. The FDA is charged with protecting consumers against Big Pharma and Black Box warnings have done little to slow the off-label sales of SSRIs and atypicals.

It’s time for the FDA to quit debating whether these drugs, alone or combined, are dangerous or effective when prescribed to children or the elderly or for any other unapproved use. The off-label sale of these drugs needs to be banned completely, once and for all.

ADHD Drugs – Cash Cow For Pharma

Evelyn Pringle February 13, 2006

“Our society viewed with loathing those who ‘pushed’ stimulant drugs on children,” says child psychiatrist Dr Peter Breggin. “Yet today, there are more children taking Ritalin and amphetamines from doctors than ever received them from illegal pushers,” he says.

“Parents and teachers and even doctors have been badly misled by drug company marketing practices,” he warns. “Drug companies have targeted children as a big market likely to boost profits and children are suffering as a result.”

The marketing campaign referred to by Dr Breggin has proven to be extremely successful At a February 10, 2006, FDA advisory committee hearing, it was reported by Dr Andrew Mosholder, a medical officer in the FDA’s Office of Drug Safety, that about 2.5 million children in this country between the age 4 and 17, currently take ADHD drugs. A government survey found 9.3% of 12-year-old boys, and 3.7% of 11-year-old girls are on the drugs, he said.

In 1980, the so-called Attention Deficit Disorder (ADD), which amounts to little more than a list of behaviors, was voted into existence as a mental illness by the American Psychiatric Association, so it could be included in the psychiatric billing Bible known as the Diagnostic & Statistical Manual for Mental Disorders, DSM.

In 1987, an H was added to the label and the illness became, “Attention Deficit Hyperactivity Disorder.” Within one year, 500,000 children in the US were diagnosed with this cash-cow disorder.

A few years later, it was classified as a disability and a cash incentive program was initiated for low-income families with children diagnosed with ADHD. A family could get $450 a month for each child diagnosed with the disorder, and the cost of treatment and medication for low-income children would be covered by Medicaid.

Then in 1991, schools began receiving educational grants of $400 annually for each ADHD child. The same year, the US Department of Education classified the disorder as a handicap, which required special services to be provided to each disabled child.

By 1996, close to $15 billion was spent annually on the diagnosis, treatment, and study of the so-called attention deficit disorder.

Over roughly the past 2 years, public health officials in the US, Canada and the UK have issued warnings about previously known, but undisclosed, risks associated with the stimulant drugs used to treat ADHD.

In September 2005, Canadian public health officials asked drug makers to turn over data from all clinical trials and post-marketing reports for the medications by the end of 2005 to be reviewed in 2006.

The February 2006 hearings, represent the third time in 2 years that the FDA has addressed the heart related side effects of ADHD drugs. This whole charade is beginning to look more and more like a repeat of the Vioxx debacle.

Foot-dragging earned the FDA a rebuke this month from Senator, Chuck Grassley (R-Iowa), chairman of the Senate Committee on Finance, which has exclusive jurisdiction over the Medicare and Medicaid programs which, according to Sen Grassley, pay hundreds of millions of dollars for prescription drugs each year, including drugs used to treat ADHD.

In a February 6, 2006, letter to acting FDA commissioner, Dr Andrew von Eschenbach, Sen Grassley said in part, “I remain concerned that while both psychiatric and cardiovascular risk signals have cropped up across this class of drugs this past year, it appears that FDA is just now beginning to ‘discuss approaches’ for studying these risks.”

“More specifically,” Sen Grassley wrote, “I question why it has taken nearly an entire year for FDA to begin to address these concerns given the serious nature of the adverse events associated with these drugs.”

In the letter, Sen Grassley noted that the FDA had recently announced upcoming meetings of two different advisory committees to examine different ways of studying adverse events related to ADHD drugs when studies showing the risks had already been done. He accused the FDA of taking a slow approach to regulating the drugs.

As examples of risk already established, Sen Grassley pointed out that in February 2005, cardiovascular concerns raised in adverse event reports led Canadian health officials to suspend market authorization of Adderall XR for six months due to a review of safety information from Shire that showed 20 international reports of sudden death and that in 2004, the FDA required Shire to include the risk of sudden death on the label.

He noted that last summer, the safety of the drugs was called into question when the FDA publicly stated that it had concerns about psychiatric side effects from the use of Concerta and specifically stated on its website that it had “identified two possible safety concerns with the methylphenidate drug products: psychiatric adverse events and cardiovascular adverse events.”

Sen Grassley also pointed out that in September of 2005, the FDA had issued an alert to healthcare professionals regarding the use of Strattera, after reviewing data showing an increase in suicidal thoughts in 12 separate studies, and directed Eli Lilly, to “revise the labeling…to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents.”

As an added pressure, Sen Grassley asked for a complete list of names of participating panel members and a complete list of conflict disclosures for both the February 9-10 2006, advisory committee and the March 22, 2006, Pediatric Advisory Committee.

The latest report made public by the FDA at the February 2006 hearings, said that between 1999 and 2003, there were twenty-five deaths in persons using ADHD drugs, including the deaths of 19 children. Officials also admitted to receiving reports of more than 50 cases of cardiovascular problems, including stoke, heart attack, hypertension, palpitations and arrhythmia.

The report only covers a 4 year period and because only between 1 and 10% of adverse events are ever reported, the numbers above represent a gross understatement of actual cases of harm from these drugs.

The report could not have considered the increase in emergency room visits associated to Ritalin abuse alone over the past decade. According to the Drug Abuse Warning Network, while there were 271 Ritalin-related emergency room visits in 1990, there were 1,478 Ritalin-related visits in 2001.

According to the National Institute of Drug Abuse, in 1999, some 165 Ritalin-related poison calls were made in Detroit; 419 cases were reported in Texas, and only 114 of those cases involved intentional misuse or abuse.

While the FDA foot-dragging has continued for years, the drug companies have been making a fortune by pushing the exact same pills that have been pedaled on the street for 50 years under names like black beauties, yellow jackets, uppers, white crosses, and bennies.

These are the exact same drugs that were handed out like candy in the 1960s and 1970s, when prescribed under the guise of diet pills, and used by truckers to stay awake, by entertainers and athletes to perform, and by people who wanted to party for days in the general population, until they were banned.

The drugs contain the exact same amphetamine that was THE main ingredient in the once popular “B-12” injections given weekly to wealthy patients in doctor’s offices all over the country until they were banned.

So here we are in 2006, with pharma making a killing by selling dangerous drugs that have been outlawed time and time again. What kind of profits are we looking at? As of September 2005, Walgreen’s prices for a 30 day supply for the lowest dosage of the top selling drugs were:

Methylphenidate (generic Ritalin) $15.69
Ritalin (brand name): $27.79
Amphetamine/dextroamphetamine (generic Adderall): $47.09
Adderall (brand name): $94.49
Concerta: $103.99
Strattera: $123.99

According to Dr Mosholder, since March 2002, prescriptions written for adults rose by 90%, to about 1 million a month as of June 2005, and to about 2 million a month for children.

If the three million people are on the lowest priced Ritalin, a round number of $30 per month times 3 million would create over $1 billion a year for the drug company alone. Then add in the medical and psychological professional fees and the grand total easily exceeds $2 billion per year. And if the patients are on Adderall, the cost of the drug triples to over $3 billion a year.

The money earned by prescribing shrinks is nothing to sneeze at either. A 2003 American Psychological Association study on “financial disincentives” for psychotherapy found that doctors could earn about $263 an hour for doing three 15-minute “medication management” sessions, verses about $156 for a single 45 to 50-minute therapy session. That represents a pay cut of 41% an hour for doing therapy only, the study determined.

However, hopefully we are about to see a dwindling of the above profit margins.

On February 10, 2006, the Drug Safety and Risk Management advisory committee said that ADHD drugs should carry the strongest warning label that they may be linked to an increased risk of death and injury.

One of the committee members who pushed for the label, Cardiologist, Steven Nissen, said something must be done to curtail the prescription rates. “I feel strongly we need to slow the growth of utilization,” he said. “When you have that kind of exposure for drugs that are suspicious, that does create a major public health concern,” he added.

This legally prescribed speed is being passed around between students in schools and colleges all over the nation. A 2002 study by the University of Wisconsin estimated that one of five college students takes Adderall, many for recreational reasons.

On July 25, 2005, CBS News reported that “Adderall and Ritalin have in fact become “street drugs” at America’s colleges and universities, where prescription stimulants often replace coffee and CliffsNotes as the study aids for today’s college students.”

According to Dr Sean Esteban McCabe, interim director of the University of Michigan Substance Abuse Research Center, a recent survey found that 6.9% of American college students have taken prescription stimulants illicitly, and up to 25% at certain elite universities with high academic pressures and admission standards.

The study canvassed students at 119 four-year colleges and universities nationwide and was published in the January 2005 issue of the journal Addiction. The specific focus of the study was the non-medical use of Ritalin, Dexedrine and Adderall.

Based on his survey, Dr McCabe found that, prescription stimulant abuse tends to lead to higher rates of other drug abuse and driving while drinking.

The survey found that students who had used a prescription stimulant non-medically in the past year were 10 times more likely to report the use of marijuana, twenty times more likely to use cocaine, and 5 times more likely to report driving after binge drinking.

On December 5, 2005, the Nashville, Tennessee based newspaper, The Tennessean reported that Athletes aren’t the only ones popping pills to gain a competitive edge these days.

“College students are turning to prescription stimulants such as Adderall and Ritalin to get them through late-night cram sessions, risking potential side effects and unknown long-term effects for a chance at a better grade,” it wrote.

“I would say it’s pretty common,” says Matthew Fleischer, a senior philosophy major at Vanderbilt University. “I know people who use it; I know people who call me and ask me if I can find some for them,” he told the Tennessean.

More than 50 college newspapers have already published articles describing Adderall abuse on campus according to CBS News.

For school age children, these drugs are providing a spring-board into early addiction. Over the past few years, high school students have been busted for using the legal speed all across the country.

For instance, on March 16, 2001, in Norwich Connecticut, 3 eighth-graders were hospitalized when they overdosed on Adderall at school.

On September 12, 2002, NBC TV News reported that 11 students were transported to Antelope Valley and Lancaster Community Hospital in Los Angeles California, for treatment of possible overdose from Ritalin. The school confiscated a large amount of Ritalin pills. “I would say in excess of 150,” said school principal Mark Bryant.

In three separate cases in 2004, Tucson, Arizona area students were caught with Adderall. Six Catalina Foothills High School students were suspended for taking or possessing Adderall while on campus, according to reports from the Pima County Sheriff’s Department reports.

Two Ironwood Ridge High School students, ages 15 and 17, were cited for exchanging Adderall in January, 2004, according to an Oro Valley, Arizona police report.

And 6 football players at Millennium High School in Goodyear, Arizona were disciplined by the Agua Fria Union High School District for taking Adderall before a game.

In both of the Tucson cases, students who had legal prescriptions for Adderall and brought the pills to school and gave them to classmates.

On October 13, 2005, a 17-year-old Waukesha, Wisconsin boy was arrested on felony charges for possession of Adderall, after the car he was riding in was stopped for a broken taillight.

On January 20, 2006, Florida Okaloosa County Sheriff Department received word that a student at Richbourg Middle School had illegally shared the prescription drug Adderall.

“Unfortunately and sadly,” Sheriff Rick Hord told reporters, “the news value may not be how unusual this is but rather how common it is.”

“We’ve had 22 cases so far that have been investigated primarily by the resource officers but in a couple of incidents by other deputies, of drugs on campus at just about every school you can name,” he said.

On February 7, 2006, two Harrington, Delaware middle school students were arrested for distributing Adderall at WT Chimpan Middle School over a period of 3 months. Both students were expelled.

If children are having problems, they need therapy not speed.

William Pelham, a well-known researcher involved with clinical trials of both Concerta and Adderall, says a major study, sponsored by the National Institute of Mental Health, showed that behavioral therapy often eliminates the need for drugs altogether.

During a one-year trial, he told The Street.com, 75% of the children who relied on behavioral treatments functioned well without the drugs. Moreover, he added, most of those children remained off the drugs a full year later.

“What this means to me is that two-thirds of ADHD kids could be taken off the medications,” Pelham told Street.com. “I do think they are grossly overused as a first line of intervention,” he added.

According to Dr Peter Breggin: “We are encouraging a generation of youngsters to grow up relying on psychiatric drugs rather than on themselves and other human resources.”

“In the long run,” he warns, “we are giving our children a very bad lesson, that drugs are the answer to emotional problems.”

Strattera – 130 Reports Of Suicidality In One Month

Evelyn Pringle February 15, 2006

A not yet released discussion paper written by the British Medicines and Healthcare Regulatory Agency, reveals that last fall, there were 130 reports of suicidality in a single month by patients treated with the attention deficit drug Strattera.

In addition, the paper reveals that there have also been more than 760 spontaneous reports of cardiac disorders, 172 reports of liver damage, and about 20 reports of completed suicides.

The large number of adverse event reports are exposed in a December 9, 2005, paper sent to the Swedish Medical Products Agency by the British agency. The information was obtained through FOIA-requests, and was released under a court order, according to Swedish investigative reporter Janne Larsson

A press release on the British discussion paper will be issued tomorrow morning, on February 16, 2006.

Drug making giant, Eli Lilly originally sought FDA approval of Strattera as an antidepressant and was unsuccessful. The drug has since been marketed as a treatment for ADHD. Strattera is approved for use with children and adult patients. However, the drug has not been tested in children less than 6 years of age or in geriatric patients, according Lilly.

Strattera is selective norepinephrine reuptake inhibitor, and the first non-stimulant drug approved to treat ADHD. Since Strattera is chemically similar to depression drugs linked to suicidal thoughts in children in 2004, last year the FDA ordered Lilly to analyze its data on Strattera.

The 12 short-term (6-18 weeks) trials reviewed involved more than 2200 patients, including 1357 receiving Strattera and 851 receiving placebo. The analysis found a greater risk of suicidal thinking during the first few months in those receiving Strattera. The average risk of suicidal thinking was about 4 per thousand with Strattera compared to no events in placebo-patients. There was 1 suicide attempt in a patient treated with Strattera.

Based on the above data, the FDA determined that the following points should be included in a boxed warning:

(1) Strattera increases the risk of suicidal thinking in children and adolescents with ADHD

(2) Anyone considering the use of Strattera in a child or adolescent for ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug.

(3) Patients who are started on therapy should be observed closely for clinical worsening, suicidal thinking or behavior, or unusual changes in behavior

(4) Families and caregivers should be advised to closely observe the patient and to communicate changes or concerning behaviors with the prescriber

On September 29, 2005, the FDA announced that it had directed Lilly to revise Stattera labels to include black boxed statements to alert health care providers to an increased risk of suicidal thinking in children and adolescents treated with this drug.

The FDA also told Lilly to prepare a Patient Medication Guide, to advise patients of the risks and precautions that should be taken, to be distributed by pharmacists when Strattera is dispensed.

Once the media reported the new back box warnings and the risks became well-publicized, spontaneous reports of adverse events began to pour in. It was between September 23, 2005 and October 25, 2005, that the 130 cases of suicidal and self-injurious behavior were reported.

In the 3 year period prior to the warning, between November 2002 and September 2005, only about 300 cases had been reported between. “This means that 30 percent of all reports of suicidality were received in one month,” Ms Larsson points out.

In 2004, Strattera was Lilly’s 6-best-selling product, raking in over $665 million in global sales. However, when the FDA ordered the black box warning last fall, Friedman Billings Ramsey analyst, David Moskowitz, told Reuters News, he cut his 2006 sales forecast for Strattera to $518 million from $685 million.

Once the black box warning was announced, it apparently did not take long for sales to drop off. According to Dow Jones New Wire on January 26, 2006, sales of Strattera, fell 8% to $168 million for the last quarter of 2005.

On February 10, 2006, the FDA safety advisory committee recommended that attention deficit drugs carry a black box warning about heart-attack risks, because the panel members agreed that the public is largely unaware of the risks and may be overusing the drugs, to include Adderall, Concerta, Ritalin, and generic versions of Ritalin called methylphenidate. The committee also recommended that a medication guide for patients and parents be provided when the drugs are dispensed.

However, Strattera, is not classified as a stimulant and is therefore, not required to carry the new proposed black box warning. However, a Lilly warning on Strattera already states: “Patients with a history of high or low blood pressure, increased heart rate, or any heart or blood vessel disease should tell their doctor before taking Strattera.”

It remains to be seen what will happen to Strattera once this latest devastating news about adverse reports reaches consumers.

Legal ADHD Speed – Becoming Drug Of Choice For Americans

Evelyn Pringle March 20, 2006

A study published online in the February 2006, Journal of Drug and Alcohol Dependence, that examined data from a 2002 survey of about 67,000 households, estimates that more than 7 million Americans have misused stimulant drugs meant to treat ADHD, and “substantial numbers of teenagers and young adults appear to show signs of addiction, according to a comprehensive national analysis tracking such abuse.”

The statistics are alarming because people are using the drugs recreationally or to boost academic and professional performance. The scientists who published the study concluded that about 1.6 million teenagers and young adults had misused these stimulants during a 12-month period and that 75,000 showed signs of addiction.

Last month, the FDA’s Drug Safety and Risk Management Advisory Committee held 2 days of hearings, and after listening to all the testimony and reviewing the data presented, recommended that all ADHD drugs carry a black box warning on increased cardiovascular risks.

This month, the Pediatric Advisory Committee is meeting on March 22, 2006, and will focus on neuropsychiatric adverse event reports and trial data on ADHD medications. The committee will also receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications, according to the FDA web site.

During the hearings last month, the Alliance for Human Research Protection, asked the FDA to issue (1) a public advisory; (2) a “dear doctor” letter to every doctor in America to apprise them of the essentially lethal side effects that are being tracked; and (3) to solicit the reporting of any and all adverse events of which they are aware.

Allen Jones, speaking as a representative of the Alliance, told the panel the FDA should instruct the pharmaceutical industry to advise the FDA of all adverse events that have been reported concerning ADHD drugs immediately, and also it should demand that all clinical trials in possession of the drug companies be turned over to the FDA so that independent researchers can review them for adverse events.

“We don’t have the luxury of time to wait for the future trials,” he pointed out. “Children are dying,” he said.

Ellen Liversridge, having lost her son to side effects of the drug Zyprexa before they were made known in a black box warnings, appeared to speak on behalf of all parents who have lost their children due to adverse reactions to prescription drugs.

“I grieve particularly today for the 51 dead of ADHD drugs that were announced yesterday by the FDA,” she told the panel.

“I guess my up-front message, front and center,” she continued, “is that you know that ADHD drugs can cause serious side effects and death, including sudden death, hypertension, myocardial infarction, stroke, and possibly bipolar disorder.

“This being the case,” she said, “I urge you to recommend that these drugs have an appropriate black box warning placed on the label starting immediately.”

Sandra Lucas, appeared at the hearing to speak on behalf of the Citizens Commission on Human Rights, a psychiatric watchdog group, and told the panel, “we do know that the side effects of the stimulants are not only present, they are extremely serious and sometimes lethal.”

“So,“ she asked the committee, “while the FDA ponders the problem of studying the issue and conducting the studies that may have inherent flaws, what real, immediate protections are to be put in place for parents and children?”

During the hearing, Drug Safety panel member, Dr Art Levin, told the committee, “I think we have to recognize that when a drug is approved and marketed the public assumes a level of comfort in the safety of that drug unless they are told otherwise.”

“And, for us to sit around and talk about this,” he continued, “to have three advisory committee meetings discussing the signals and not to make, at the very least, a very strong warning to people that there is uncertainty here about the safety of these drugs and that they need to be aware of that pending clarification I just think is inappropriate, unethical behavior.”

Committee member, Dr Steve Nissan advised, “we have to elevate the level of concern and if it slows the growth of this, that is probably appropriate because I think most observers would argue that ten percent of ten year-olds do not have this disease and what has happened is that this is out-of-control use of drugs that have profound cardiovascular effects and, as a cardiologist, I can tell you that,” he said.

Panel member, Dr Curt Furberg, recommended that ADHD drugs also come with a patient guide “so that when parents are filling prescriptions for their kids they get a written document laying out the state of knowledge, or lack of the state of knowledge and the potential risks so they are reminded each time that there is a potential risk and we are trying to find solutions to it,” he advised.

Since last month’s recommendation for a black box warning on cardiovascular events, FDA reviewers announced a recommendation for stronger warnings on all ADHD drugs due to reports of numerous adverse events like mania and psychosis in clinical trials, including modafinil.

On March 14, 2006, an FDA review was posted to the agency’s web site in advance of next week’s meeting. The FDA said stronger warnings are needed on the risk of psychosis, a mental disorder characterized by the inability to distinguish real and imaginary events.

“The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD,” according to a memo dated March 3 from two members of the agency’s ADHD psychiatric review team.

The review said current labeling neither addresses those concerns nor does it “clearly state the importance of stopping drug therapy in any patient who develops hallucinations or other signs or symptoms of psychosis or mania during drug treatment of ADHD.”

From January 2000, through June 30, 2005, the review found nearly 1,000 reports of psychosis or mania possibly linked to the drugs, including Adderall, Concerta, Ritalin and Strattera. The reports were pulled from the FDA’s database and from the drug makers themselves after the FDA had requested additional information from the drug companies.

The FDA found a “substantial portion of the psychosis-related cases were reported to occur in children 10 years or less,” an age group which according to the FDA, does not typically suffer from psychosis.

“The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking and deserves further evaluation,” the FDA noted.

Last fall, on September 29, 2005, the FDA issued a public health advisory to alert physicians of reports of suicidal thinking in children and adolescents associated with Strattera, and directed Eli Lilly, manufacturer of Strattera, to develop a Medication Guide for patients and caregivers.

Although Strattera is marketed as a “nonstimulant” medication, according to pediatrician, Dr DuBose Ravenel, MD, FAAP, of Cornerstone Pediatrics, “it is in fact a stimulant every bit as much as the traditional stimulants, as evidenced by even a cursory consideration of its pharmacological action, and evidenced by the fact that it is classified as such by the World Health Organization.”

Dr Fred Baughman, ADHD expert and well-known author, will testify before the committee next week on behalf of the International Center for the Study of Psychiatry and Psychology.

“We know these drugs are poisons,” Dr Bughman warns, “and we know they are highly addictive, dangerous and sometimes deadly.” He points to the senseless death of children on ADHD drugs. “Matthew Smith is dead today not because of ADHD,” he says, “but, as carefully delineated by the medical examiner, his chronic Ritalin/methylphenidate exposure.”

“Nor is there any other plausible explanation for the death of Stephanie Hall, 11 years old of Canton, OH,” he advises. “No physical predisposing factor other than Ritalin was present,” he notes, “leading up to her death, in bed, by cardiac arrhythmia.”

“The main question the FDA needs to answer concerns ADHD,” Dr Baughman says, “the “disorder” these addictive, dangerous, sometimes deadly drugs are used to treat.”

“The shocking fact of the matter is that it is not a disorder/disease at all,” he explains, “children said to have it are entirely normal meaning they bear no objective, demonstrable, diagnosable, abnormality, meaning there is no justification for prescribing these or any other drugs for so-called ADHD–a wholly fictitious, wholly subjective entity.”

According to Dr David Stein, Ph D, Professor of Psychology at Longwood University, “the risks of psychiatric drugs in the bodies of children and teenagers is well documented and needs no further elaboration.”

He wants the advisory committee to address two issues: (1) the validity of ADD/ADHD as diseases; and (2) effective alternative behavioral treatments that reduce reliance on drugs.

Dr Stein’s behavioral/cognitive treatment methods have won awards from the American Psychological Association (One of top ten research projects at the 1998), the International Center for Psychiatry and Psychology (2005), and the Ritalin Litigation Conference (2001).

“It is my hope,” he says, “that the committee will consider that within the decision tree, the physician’s choice to use drugs can be lowered in favor of, at the very least, recommending properly designed behavioral parent training.”

“The risks of legal liability and the risks of medical damage to children,” Dr Stein advises, “can be reduced with the augmentation and further development of proper behavioral treatments.”

According to court certified expert and author of many books on ADHD, Dr Peter Breggin, all stimulants commonly cause “a continuum of stimulation, including agitation and irritability, anger, hostility, disinhibition, hypomania and mania.”

The stimulant or activation syndrome, he advises, was originally observed decades ago with stimulant drugs such as amphetamines, Adderall, and Dexedrine, and methylphenidates such as Ritalin and Concerta.

It also occurs, he notes, with dexmethylphenidate such as Focalin, and selegilines like Sparlon and Provigil, as well as the atomoxetine, Strattera.

In a review of the summary data for the FDA Spontaneous Reporting System through March 1997, Dr Breggin counted the following: Psychosis, 43; hallucinations, 44; and psychotic depression, 11. His review also counted more than 50 reports in the combined category of overdose, overdose intentional, and suicide attempt.

“In regard to both amphetamines and methylphenidate,” he explains, “there are a surprising number of animal and human studies showing persistent biochemical changes and atrophy after several weeks or more exposure.”

“While the changes in children are sometimes mistakenly attributed to ADHD or OCD, they are a known effect of stimulants on the animal brain,” he advises. “A known toxic drug effect is a far more likely culprit than a highly speculative “biochemical imbalance” in these children,” he adds.

Dr Breggin will also testify at the advisory committee hearing on behalf of the International Center for Psychiatry and Psychology, and will recommend that labels for stimulant drugs include the following neuropsychiatric warnings:

(1) A warning concerning depressive/OCD ADRs that includes depression, apathy, lethargy, listlessness, tiredness, sadness, crying, withdrawal, and social isolation as well as worrying, ruminating, over-focusing, and other obsessive-compulsive behaviors.

(2) A warning concerning stimulation or activation ADRs that includes insomnia, anxiety, agitation, panic attacks, irritability, hostility, aggressiveness, violence, impulsivity, disinhibition, hypomania, and mania.

(3) Strengthened warning concerning psychosis, paranoid ideation and hallucinations.

(4) Strengthened warning about rebound, dependence and abuse, especially for methylphenidate products (all current methylphenidate labels especially inadequate).

(5) A specific warning that the combination of depressive, obsessive-compulsive and stimulant ADRs poses a serious risk of dyscontrol or disinhibition with suicidal and/or violent behavior.

(6) A warning in the labels for amphetamine and methylphenidate products about persistent brain dysfunction and atrophy.

Information released by the FDA last month showed that between 1999 and 2003, seventy-eight million prescriptions were written for ADHD drugs in children ages 1 to 18, and more than 14 million prescriptions were written for adults.

During last month’s hearings, Safety Drug committee member, Dr Steve Nissen, said he is certain the public is 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.”