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about the existence of hidden pediatric studies, Mr Kendall contacted the drug makers directly requesting the unpublished studies and when none of them complied, he contacted a government agency which provided 6 unpublished studies on 3 SSRIs.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 “When we got the unpublished data and put it in with the published data, something happened,” Mr Kendal told New Scientist.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For instance, the unpublished studies on Zoloft, New Scientist said, “suggested the drug increased suicide-related events such as suicidal thoughts or attempts by 14 times compared with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.

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