The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Reviewing ADHD Drugs – FDA Goes Through the Motions

Evelyn Pringle March 12, 2006

Some of the top-selling drugs of all time are those prescribed to treat attention deficit disorders. Drug companies have physicians in every field of medicine pushing these medications and dole out millions of dollars worth of free samples each year to make sure they are passed out like candy.

A new ADHD drug is set to come on the market that supposedly can keep people awake for days at a time with no problems. Just what we needed, especially for hyper little kids.

I wonder if this means they will remain calm as they sit wide-awake watching TV and playing video games for days while the rest of the family sleeps.

The drug Sparlon is manufactured by Cephalon and is a clone of Provigil, another drug already on the market. Sparlon contains modafinil, the same exact active ingredient contained in Provigil which is approved for the treatment of patients with narcolepsy, sleep apnea and shift work sleep disorder, according to the FDA.

The drug’s approval will be considered by the FDA’s Psychopharmacologic Drugs Advisory Committee at a public hearing scheduled for March 23, 2006.

The day before the Sparlon hearing, the FDA’s Pediatric Advisory Committee is scheduled to meet to discuss neuropsychiatric adverse events and cardiovascular adverse events reported on patients who were treated with ADHD stimulant drugs already on the market.

The drugs under review include Ritalin from Novartis, Adderall and Adderall XR from Shire Pharmaceuticals, Concerta from Johnson & Johnson, and generic versions of Ritalin.

On February 9 and 10, 2006, the FDA’s Drug Safety & Risk Management Advisory Committee held hearings on the same topic, and after reviewing the information provided at the hearing, the panel recommended that black box labels be added to the labels of all stimulants.

However, the FDA is not bound by the recommendations of its advisory panels, and critics of the drugs say the close 8-7 vote by the panel, means there will be spirited debate within the agency over whether black box labels will be added.

Several members of the panel said they voted for the warning in part, because they were alarmed over the sharp rise in prescriptions written for both children and adults. During the hearing, the committee was informed that between 1999 and 2003, roughly 78 million prescriptions were written for children under the age of 18, and 14 million more were written for adults.

In a stark contrast, only 190 million prescriptions were issued for children and adults during the 12 year period between 1992 and 2004.

According to the FDA numbers on adverse events, between 1999 and 2003, there were 25 deaths reported for persons using ADHD drugs, and 19 were children. The agency also acknowledged that more than 50 cases of cardiovascular-related events were reported in the same time period including stoke, heart attack, hypertension, palpitations and arrhythmia.

Critics say the numbers revealed at the hearings represent a gross understatement because only 1% to 10% of adverse reactions are ever reported to the FDA, and it would therefore be better to add a black box now and remove it later if studies prove there is no link between the stimulants and sudden death and heart disease.

Supporters of the drugs, say the warning is based on inconclusive evidence and would deter physicians from prescribing the medications and scare patients away from taking the drugs.

Because Cephalon claims Sparlon should not be classified as a stimulant, analysts predict the company could get a boost if the FDA agrees and requires the other drugs to carry a black box warning. One of the issues discussed at the March 23, hearing will likely be how to distinguish Sparlon’s labeling from other ADHD drugs.

If approved, Sparlon will be co-marketed under an agreement with Johnson & Johnson, which will focus on the pediatric market through its McNeil Consumer & Specialty Pharmaceuticals unit.

McNeil’s sales team will promote Sparlon to psychiatrists, pediatric neurologists and pediatricians, while Cephalon’s 400-person sales force will focus on non-pediatric specialists and primary care physicians.

When Cephalon requested FDA approval for Sparlon, it submitted the results from three clinical trials on children aged 6 to 17 that the company said indicated better results in children taking Sparlon compared to children who received a placebo. Each trial lasted 9 weeks and the most common side effects noted were loss of appetite, mild insomnia and headaches.

But Cephalon has not been sitting idle while waiting for approval of its Provigil clone. Last year it had to figure out a way to deal with the fact that Provigil’s patent was set to expire in 2006. Through some last minute legal footwork, the company was able to negotiate agreements with 4 generic firms that will allow Cephalon to continue to sell the drug unchallenged until at least 2011

Provigil’s approval for a silly diagnosis like “shift-work sleep disorder” is a good example of disease-mongering, described in the book, “Selling Sickness: How The World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients,” by Ray Moynihan and Alan Cassels, which explains how drug companies foster the creation of bogus disorders to create markets for their pills, through “medicalization” of normal states of health.

In the same vein, many experts say the sale of ADHD drugs in general is nothing but a racket. Dr Fred Baughman, a board certified child neurologist and Fellow of the American Academy of Neurology, calls ADHD the “greatest health care fraud of modern times.”

Clinical social worker Peter Dwyer, has seven years’ experience working with troubled children, and has served as director of a large therapeutic foster care program. He also attributes the ever-rising sales numbers for ADHD drugs to a grand marketing scheme.

“It is easy to see why stimulants dominate the treatment of ADHD,” he says, “drug companies spend over $20 billion a year on promotion – more than they spend on research.”

“The bottom line,” Mr Dwyer explains, “professionals and the public are bombarded with a stream of “research” and “information” financed and spun by the people who make and sell these drugs.”

“The conflict of interest is palpable,” he adds.

And anyone who believes Provigil is free of the side effects associated with other ADHD medications needs to speak to Susan Florence who experienced a terrifying adverse reaction to the drug.

“I took one pill and I thought I was coming out of my skin,” she recalls, “I felt as if someone had climbed inside me.”

“It was one of the worst experiences of my life,” she says.

Nonetheless, Cephalon has done an excellent job of promoting Provigil. The US Air Force has even adopted the drug as one of its official “go pills” for pilots whose missions stretch out more than 12 hours, according to Business Week on November 1, 2004.

Ever since Provigil hit the market, Cephalon stayed busy figuring out ways to promote its off-label use for a multitude of ailments including ADHD, and with obvious success. SG Cowen & Co analyst, Eric Schmidt, told Business Week he figures more than 50% of Provigil sales are for unapproved uses.

And 50% in off-label sales adds up to enormous profits. In 2004, US doctors wrote 1.9 million prescriptions for Provigil, generating $414 million in sales. In 2005, Cephalon saw Provigil sales reach $512 million, according to Forbes.com on March 13, 2006.

While waiting for Sparlon to be approved, the company has been using every trick in the book to boost sales of Provigil for the treatment of ADHD.

For instance, Dr Fletcher Taylor, from Tacoma, Washington, was paid to meet with small groups of doctors to talk about Provigil.

He conducted a study on the use of Provigil for ADHD, which he claims showed positive results. However, according to Business Week, Dr Taylor says “he does not bring up the use of Provigil for ADHD in his talks, but he answers questions – as he is permitted to do – if one of the doctors in the group brings it up.”

“Usually people do ask,” he told Business Week.

I’m quite sure they do ask, probably much like the people on TV who used to just happen to step out of the audience to be cured by faith-healer 50 years ago.

Cephalon also employs the well-known off-label marking technique of funding continuing medical education seminars (CMEs), under the guise of providing doctors with information related to how certain ailments can be treated by drugs that the company just happens to sell.

For example, Cephalon paid for a CME that focused on the treatment of daytime sleepiness experienced by Parkinson patients and explained how Provigil might be a useful therapy.

The sponsor of the program, a firm called Projects in Knowledge, told Business Week that Cephalon paid for the program but had no input on the material discussed.

And of course I believe that.

Another tried and true method of promoting off-label use involves publishing the results of favorable studies funded by drug companies in medical journals. “Journals have devolved into information laundering operations for the pharmaceutical industry,” according to Richard Horton, editor of the Lancet, in March 2004

In a prime example of this practice, the August 4, 2005 New England Journal of Medicine, published a report on a study funded by Cephalon in which the lead author, Dr Charles Czeisler, from Harvard Medical School and Brigham and Women’s Hospital, had a professorship endowed by $2 million from Cephalon.

In the report, Dr Czeisler claimed night-shift workers remained more alert with Provigil and wrote a glowing summary of the study. “I would characterize [Provigil] as the treatment of choice with patients with shift-work disorder,” he said.

However, Dr Robert Basner, director of Columbia University’s Cardiopulmonary Sleep and Ventilatory Disorders Center, published an editorial on the study in the same issue of the NEJM and said the researchers’ data showed only slight improvements in workers wakefulness and productivity with Provigil, and pointed out that the drug seemed to exacerbate insomnia for some patients.

“That’s not a very robust endorsement of the drug coming from the investigators themselves,” Dr Basner wrote. “This drug is little better than nothing in terms of making them less sleepy during shift work at night,” he added.

Experts pretty much agree that Sparlon will be approved for treating children with ADHD so before too long the “little better than nothing” clone will not doubt be ringing up the cash registers all over the US.

Filed under: 'ADHD', 2006, Adderall, Cephalon, Concerta, FDA, FDA hearing, Johnson and Johnson, Novartis, Provigil, Ritalin, Shire, Sparlon

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.”

Filed under: 'ADHD', 2006, Adderall, Breggin, FDA, FDA hearing, prices, Ritalin, Shire, Strattera

Adderall Online – Black Market Profits In Plain Sight

Evelyn Pringle February 24, 2006

Dubbed “Kiddie Coke,” Adderall is being abused by increasing numbers of high school and college students all across America. It’s difficult to quantify the extent of the abuse among students due the availability of the drug through legal prescriptions and on the internet.

Adderall is an amphetamine, a class of stimulant drugs that were widely abused when prescribed as diet pills until they were banned for that use more than 2 decades ago. However, according to clinical social worker, Catherine Wood: “The mother’s little helpers of the 1960’s and 1970’s are all available now on the Internet.”

Adderall maker, Shire Pharmaceuticals, cannot claim ignorance about the obvious rise in profits resulting from the sale of one of its top selling drugs on the internet to people without a valid prescription. And therefore, in addition to enjoying the black market profits in plain sight, Shire must be held accountable for any and all harm done to customers who unwittingly purchase Adderall online.

As for legal prescribing of ADHD drugs, in the last 10 years, the number of preschoolers taking the drugs has tripled and the number of school-age children has multiplied by 20, according to the November 20, 2004 edition of Learning. Of the more than 2 million children prescribed ADHD drugs, Adderall users represent about a quarter of the market.

More and more high school students are using the drug illegally. A 2004 University of Michigan study on non-medical use of amphetamines in schools nationwide, found 4.9% of 8th graders had used amphetamines in the previous year, 8.5% of 10th graders had used the drug, and with 12th graders, one in 10 seniors admitted to non-medical use of amphetamines.

Another 2005 report from the Partnership for a Drug Free America, based on a survey of more than 7,300 teenagers, also found one in 10 teenagers, or 2.3 million young people, had tried prescription stimulants without a doctor’s order, and 29% of those surveyed said they had close friends who have abused prescription stimulants.

The use of ADHD drugs by college students is on the rise. Beyond the legitimate prescription of such medications lies new territory marked by illegitimate and inappropriate uses of stimulants, “practices that are often not even covert,” according to Dr Richard Kadison, chief of mental health at the University Health Services, Harvard University, in the September 15, 2005, New England Journal of Medicine.

“Increasing numbers of students, and sometimes their families,” Dr Kadison says, “request medication to provide an “edge,” even if the students have no clinically significant impairment of functioning.”

Many college students report what they call “pharming”: using stimulants for recreation, to work more efficiently, and to lessen the need for sleep. A July 2005, Student Drug Research Survey of University of Maryland students found Adderall was the third-easiest drug to get at the University after alcohol and marijuana.

Because stimulants have been widely prescribed to children for decades, college students think Adderall is safe and know the symptoms to describe to get a doctor to write a prescription. The challenge for physicians, Dr Kadison says, is to determine which patients have a legitimate need for medication, particularly given recent warnings about the safety of some of these drugs.

The widespread tolerance of Adderall use resembles the blind eye too many parents cast on teenage drinking prior to the 1990s. And since it is primarily considered a study drug by many students, even students who are anti-drug have divided opinions about Adderall use. Typically, “Dealers” have valid prescriptions for the drug and sell their unused pills to friends for little or no profit.

But the fact remains, under federal law it is illegal to possess a Schedule II drug, such as Adderall, without a prescription and yet ironically, college students are using Adderall illegally in hope of doing better on law school admission tests.

Shortly before taking the Law School Admission Test at the University of Colorado, Carrie, a college senior, downed an Adderall with her breakfast of eggs and toast. “I’m nervous because I’m taking a test that will determine the rest of my life,” she said in an interview with the Wall Street Journal, on November 8, 2004.

Carrie had no prescription for the drug but had bought 10 pills for $2 each from a friend’s roommate. She took practice tests with and without pills, she told the WSJ, before deciding that Adderall would help improve her score.

Another pre-law student, Chul Yim, a graduate of the University of Nevada, who has a job in Washington, on Capitol Hill, told the WSJ, he’s wrestling with whether to use a stimulant before he takes the Law School Admission Test.

“I really can’t fail,” Chul says, “because it’s not just me that’s failing. I fail for my parents and my entire family. Even if it bumps my score up an extra point, it’s worth it.”

These pre-law students obviously have no knowledge of the possible legal consequences they could face for using Adderall illegally. Serious criminal laws apply to the use of the drug and if caught, their plans for a career as an attorney would be history.

An article titled, “Students buy Adderall from students with prescriptions despite physical, legal and ethical consequences,” in Grinnel College’s Scarlet & Black Newsletter, Volume 122, Number 15, Feb 10, 2006, lists the criminal laws and penalties that apply as:

(1) Classified by the DEA as a Substance II, the same legal category as cocaine and heroin. For first time possession of between five and 49 grams, the minimum federal sentence is five years.

(2) If death or serious injury occur, the minimum sentence is 20 years.

(3) Individual first time offenders can be fined up to two million dollars.

(4) If a first-time offender possesses more than 49 grams, the minimum sentence is ten years and the maximum is life imprisonment.

In addition, the health risks associated with Adderall can be lethal. Concerned about the risk of sudden death or serious injury associated with stimulants used to treat ADHD, on February 10, 2006 the FDA’s Drug Safety and Risk Management advisory committee said the drugs should carry the most serious type of warning label.

The proposed “black box” statements would inform doctors, patients and parents of the uncertainty regarding the risk the drugs may pose to the cardiovascular system. The label for Adderall has included the warning since 2004.

An FDA review of its own databases found reports of 25 deaths in children and adults between 1999 and 2003, and 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia.

The FDA said it has tallied an additional 26 deaths between 1969 and 2003 in patients on the drugs involving death by suicide, intentional overdose, drowning, heat stroke and from underlying disease.

The rate of possible underreporting is unknown. The adverse reactions system of reporting is voluntary and said to only represent between 1 and 10% of actual adverse events.

“Does the FDA get 10 percent of cases, 20 percent? Nobody knows,” said Kate Gelperin, a medical officer in the FDA’s Office of Drug Safety. Any link to the drugs “is really only a rough estimate,” she told the panel.

The FDA may also undertake short-term studies into the effect of the drugs on blood pressure, heart rate and the heart muscle itself, said Dr. Peter Gross, chairman of the advisory committee.

The unsolicited recommendation was a surprise and caught the FDA off guard. The agency is not required to follow the advice of the panel but it generally does.

When asked why the committee approved a recommendation they had not been asked to consider, Dr Gross said: “No. 1, because of the seriousness of the side effects – the sudden deaths. No. 2, there is a sense maybe the diagnosis of ADHD is being applied where it shouldn’t be applied,” according to the Associated Press on February 10, 2006.

Filed under: 'ADHD', 2006, Adderall, addict, drugging children, FDA, Shire

Adderall’s Rollercoaster Year

Evelyn Pringle January 2006

Shire Pharmaceuticals is the global market leader in the sale of attention deficit drugs with the products Adderall, an instant-release amphetamine introduced in 1996, and Adderall XL, a timed-release version of the drug, introduced in 2001.

Adderall and Adderal XL are the top selling attention deficit treatments in the US. In 2004, Shire captured 28% of the US market and according to Bloomberg News on February 10, 2005, Shire sold about $759 million worth of Adderall XR in the US and roughly $10 million in Canada.

The drug contributed about half of the firm’s $1.3bn (�695m) annual sales total, according to the February 11, 2005 Guardian.

For the past year, Shire has been a continuous rollercoaster ride. The company took a major tumble in February 2005, when Canadian health authorities pulled Adderall off the market due to reports of 20 sudden heart-related deaths and strokes in children and adults using the extended-release pill.

Fourteen of the deaths were children and two of the 12 strokes were in children. The adverse events were reportedly not associated with drug overdose or misuse of the drug.

The Canadian news release said the incidence of serious reactions leading to death were higher with Adderall and Adderall XR combined, than with any other medications in the same class of drugs.

In immediate response to the action, the Guardian reported a 10% fall in Shire Pharmaceuticals’ share price.

Instead of investigating the matter at the time, the FDA merely posted an alert on its website that said Health Canada has suspended marketing of Adderall XR products due to concern about reports of sudden unexplained deaths and issued an advisory to healthcare professionals that the Canadian regulatory agency had suspended the sale of the drug.

However, not only did the FDA not investigate, an agency employee reportedly tried to talk Canadian officials out of banning Adderall, in an attempt to deflect FDA involvement in another drug-safety related controversy. Congressional committees were already grilling the FDA on its failure to reveal safety problems with other classes of top selling drugs.

Shire appealed the decision to remove its product from the market to Health Canada, and a panel of experts was convened to determine whether Adderall was more dangerous than other attention deficit drugs sold in Canada.

Seven months later, in August 2005, Health Canada reinstated approval for Adderall based on a finding by the New Drug Committee that the product could not be conclusively associated with the increase in the cardiovascular events and deaths.

According to the October 11, 2005 Canadian Medical Association Journal, health officials voted to reintroduced the drug not because the agency found it safe, but because “an independent panel found it impossible to accurately ascertain whether the drug increases the risk of cardiac death.”

The committee in fact evaded the underlying safety determination. Committee Chairman, Dr Mitchell Levine, said it was impossible to prove or disprove that Adderall increased the risks of sudden cardiac death or stroke, and when compared to similar drugs, it was also impossible to determine whether Adderall “was particularly worse or more harmful.”

The New Drug Committee did find that it is “biologically plausible” that there is an increased risk with any stimulant drug, but due to the uncertainty of whether Adderall was more dangerous than others, the panel recommended that it be returned to the market with a revised warning label.

The new package insert included warnings about the misuse of Adderall and said that Adderall generally should not be used in patients with structural cardiac abnormalities.

The good news in Canada brought no time for a breather, because another problem was on the horizon for Shire in the fall of 2005. Impending generic competition was threatening to knock Adderall off its top shelve pedestal in the market.

Shire quickly took legal action to defend its number one position by asking US regulators to impose more testing on generic versions of the drug and filed law suits against Barr Laboratories and Impax Laboratores for patent infringement.

The company also filed a Citizen Petition with the FDA, to require competitors to show that their products were equally effective in treating patients, before allowing them to be sold, to delay approval through more testing.

However, even with these legal bases covered, Shire’s worries were far from over. At the start of the new year, the next round of headaches arrived, when the FDA finally awoke from its usual and customary position of being asleep at the wheel when it comes to warning citizens about potential harm from lethal products of the pharmaceutical industry.

On January 6, 2006, Medical News Today, reported that the FDA had asked its Drug Safety and Risk Management advisory committee to examine ways of studying the potential cardiovascular risks of attention deficit drugs in response to reports of deaths and other serious adverse events in persons who had taken the medications.

According the FDA web site: “Cases of sudden death and serious adverse events including hypertension, myocardial infarction, and stroke have been reported to the agency in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult populations.”

“The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks,” it said.

The agency’s web site does not specifically identify any drug by name but it’s no secret that Adderall is the most commonly prescribed attention deficit drug in the US.

That said, Shire is definitely not the only company worrying about the FDA investigation. The financial stakes are high for every attention deficit drug maker. Billions of dollars in sales are hanging in the balance.

According to the market research firm IMS Health, overall spending on attention deficit drugs has increased from about $750 million in 2000 to over $3 billion in 2004.

Prescriptions for these drugs are on the rise for people in every age group. On September 15, 2005 the Associated Press reported that the use of drugs for attention deficit hyperactivity disorder is growing at a faster rate among adults than children.

Nearly 1.5 million Americans over 20 years old are using the drugs, according to Medco Health Solutions, the nation’s largest prescription benefit manager. Between 2000 and 2004, the use of these drugs has doubled among adults ages 20 to 44, and has increased 56% among children, Medco reports.

However, the most shocking increase in the use of attention deficit drugs is with toddlers. From 2000 to 2003, prescriptions for children under 5 contributed to an overall 23% increase for all children, according to an annual analysis by Medco.

And last but not least, not surprisingly, Adderall is becoming the recreational drug of choice for high school and college students. In a July 2005, Student Drug Research Survey of University of Maryland college students by the Maryland Drug Early Warning System, Adderall was listed as the third-easiest drug to get at the University after alcohol and marijuana.

On January 23, 2006, the Fond Du Lac, Wisconsin school board voted to expel students involved in selling and trading Adderall. Eleven students in all were suspended for their part in distributing the drug.

School authorities referred the students to prosecutors after arresting them last month. Police say a 14-year-old female student stole the drug from her three siblings to whom it had been prescribed. She took some of the pills herself and sold some to classmates.

As of January 19, 2006, Shire was back at the top of the rollercoaster again after it settled its legal battle with generic rival Impax. Once Shire confirmed the deal, company stock rose 8%.

The agreement is said to allow Shire five years to switch patients from Adderall XR to its newer hyperactivity drug and gives Impax the right to sell a generic form of Adderall XR from 2010. Impax will also pay a royalty on any sales of the generic and could become Shire’s authorized partner if another firm launches a generic rival to Adderall XR.

Although Shire is said to be involved in settlement discussions with Barr Laboratories, analysts agree that any potential agreement with Barr is unlikely to be so favorable.

Because the system of reporting adverse events is voluntary, analysts say that the events reported on any given product represent only 1-10 percent of the actual number of adverse reactions. In other words, there may have been thousands of deaths in people on Adderall.

So the question remains, how many more reports of deaths and serious injuries have to surface before regulatory officials protect potential victims by pulling Adderall off the market.

Filed under: 'ADHD', 2006, Adderall, drugging children, Shire

Donate: Stop Preventable Infant Deaths and Birth Defects

Click here to lend your support to: Stop Preventable Infant Deaths and Birth Defects and make a donation at www.pledgie.com !

Be a Facebook Fan!

UNITE FOR LIFE Fan Page

UNITE FOR LIFE Fan Page

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Join 730 other followers

Get the latest from the Fiddaman blog

Archives

UNITE News

August 2014
M T W T F S S
« Feb    
 123
45678910
11121314151617
18192021222324
25262728293031

Where Do People See This Blog?

Protect babies from drugs

Eli Lilly Funds Depression Screening Initiatives

depredrugshirt

Matthew Schultz killed by Effexor. Two hours old.

More Photos

Big Pharma Victim

  • I haven't been on in awhile thanks to all those who followed 3 years ago
  • @LindsayRush yay IOWA! 4 years ago
  • Another rainy day here in IOWA. Well at least i had a good time swimmin yesterday. 4 years ago
  • Hey everyone hope you have a great day! THanks to all the new followers :) and for those that continue to follow 4 years ago
  • srry if I dont get on here much I mostly just look at my facebook acct. thanks to all the new followers! 4 years ago

The Indiana Star

Christiane Schultz

  • Is not coping well at all. Loss sucks! 4 years ago
  • is scared to bond with this baby, just in case. 4 years ago
  • Happy 6 months today baby. I love you Matthew. 5 years ago
  • Living with loss, sucks. 5 years ago
  • Thinking I need to discuss plans for this baby soon or I will be having it in my doctors office. Where do I deliver? 5 years ago

Amery Schultz

Seeking Parents in Missouri for Celexa / Lexapro Class Action – Call 800-827-0087

TWEET FOR LIFE

BREATH – The Official Blog of MADNAP – momsandmeds.com

RSS BREATH

  • Untitled
    Originally posted on The Bitter Pill: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…
  • Untitled
    Originally posted on The Bitter Pill:In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman…
  • Antidepressants Again Linked to Preterm Birth & Seizures
    In what was more than likely originally an attempt to prove that depression causes birth complications, researchers from Yale, Tufts, et al found in two new studies that antidepressants increase the risk of preterm birth and seizures. Read more at this link on the newly redesigned UNITE website.
  • Who Could Do This On Purpose
    Read this blog to find out
  • Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed
    Canadian Regulation on Fetal Exposure to Psychotropic Drugs – Public Input Needed (Cross-Posted on The Bitter Pill blog) Amery and Christiane Schultz have been asked to provide input on proposed recommendations regarding psychotropic drugs in pregnancy in Canada. Amery & Christiane are hard-working activists affiliated with UNITE and MADNAP. Please send […]

UNITE ARCHIVES – Victims & Survivors Against The MOTHERS Act: YouTube Playlist

Videos: Psych Drugs, Birth Defects, Infant Death, Violence & Suicide

UNITE ARCHIVES – Add Your Group To The Coalition Against The MOTHERS Act

CADIMA: 54 Groups and Counting!

UNITE ARCHIVES – The MOTHERS Act Citizen Voting Area on Open Congress

Status: 76% AGAINST S. 324 The MOTHERS Act. Vote & Comment.

UNITE ARCHIVES – Join the Coalition Against The MOTHERS Act on Facebook!

3,271 Facebook Members and Counting!

UNITE ARCHIVES – Stop The Dangerous and Invasive MOTHERS Act!

13,500 Signatures and Counting!

Follow

Get every new post delivered to your Inbox.

Join 730 other followers

%d bloggers like this: