October 26

FDA New Drug Safety Website – ADHD A Huge Profit-Engine for amphetamine-like drugs – The Street

FDA New Drug Safety Website – ADHD A Huge Profit-Engine for amphetamine-like drugs – The Street

Sun, 22 May 2005

“After 25 years and 35 studies, there is not a single straightforward experiment comparing typical unmedicated children with an ADHD diagnosis to typical controls.”

But science is not what the psychotropic drug industry relies on to bolster sales.

Industry relies on an army of psychiatrists affiliated with academia who serve as marketeres advocating the use of psychostimulant drugs for ADHD-a non-specific unvalidated behavioral “condition.”

And these marketeers get paid handome “consultancy” fees.

Gretchen LeFever did the unthinkable. She pursued a line of research that threatens the interest of the university’s pharmaceutical supporters–for this she got fired.

For years Dr. LeFever has been documenting an inordinate, medically unsupported rise in the diagnosis of children with ADHD in eastern Virginia – as high as 17% compared to the national average of 5%.

That inflated diagnosis translates into doctors’ high prescribing rates which enriches the manufacturers of ADHD drugs:

Eli Lilly, manufacturer of Strattera; Johnson & Johnson manufacturer of Concerta ; Shire manufacturer of Adderall, the most popular ADHD drug; and Novartis which continues to profit from Ritalin.

Not only is there no medical justification for prescribing these drugs to most children, but the drugs have been linked to serious, even potentially life-threatening adverse effects.

In the wake of public outrage at the concealment of adverse drug effects, the FDA has just created a new website providing drug safety information: http://www.fda.gov/cder/drugSafety.htm

The following information about drugs prescribed for ADHD is on FDA’s new website:

The amphetamine, Adderall (extended release) was linked to 20 sudden deaths-14 in children-and was withdrawn from market by Health Canada. Concerta (methylphenidate,, much like Ritalin) is linked to difficulty breathing, irregular, fast heart beat, high blood pressure, and liver damage. Strattera (atomoxetine) an anti-depressant, is linked to high systolic blood pressure, tachycardia, hypotention, abdominal pain, nausea, vomiting and mood swings.

Dr. William Pelham who has tested Concerta and Adderall, notes that 75% of children who relied on behavioral treatments in a trial comparing drug and non-drug approaches, functioned well without ADHD drugs for a full year as well as the year following the study. “What this means to me is that two-thirds of ADHD kids could be taken off the medications.”

Dr. LeFevere’s “crime” appears to be her efforts to alert the public about a potential health hazard. Why are bioethicists not supporting Dr. LeFevere? Might they be chasing after PhRMA give-a-ways?

Contact: Vera Hassner Sharav

Attention Deficit Pays at Shire
By Melissa Davis
Senior Writer

For a while, Gretchen LeFever was able to draw national television coverage to her crusade: what she calls the excessive diagnosis and treatment of attention deficit hyperactivity disorder.

The pediatric clinical psychologist made a name for herself after studying the apparent prevalence of ADHD in her eastern Virginia community. At one local school district, for example, LeFever found that 17% of the children in grades two through five had been diagnosed with ADHD. Moreover, she discovered that the vast majority of those diagnosed with the disorder were being treated with prescription stimulants like Ritalin and the next-generation drugs manufactured by Eli Lilly, Johnson & Johnson and Shire Pharmaceuticals.

On average, only about 5% of the nation’s children supposedly suffer from ADHD. So LeFever’s findings, representing the highest rates of ADHD ever documented, led to stories by major news outlets including CBS, CNN and NPR.

But soon enough, critics attacked her research. LeFever believes some were actually bankrolled by the pharmaceutical industry. She says even her employer, the financially strapped Eastern Virginia Medical School, turned against her. The university failed to return a phone call from TheStreet.com.

“I was one of the more notable researchers at the school,” LeFever says. “But suddenly, everything I did was under scrutiny.”

Now, LeFever says she no longer feels surprised. After all, she has come to realize, her research could threaten a major growth market for the cash-rich drug industry.

In this third of five articles exploring apparent conflicts of interest in the medical business, TheStreet.com examines how an increasingly popular but still controversial diagnosis has paid off for big pharma companies — and how the industry might benefit from silencing troublesome questions.

Booming Business

As LeFever fights to keep her job, pharmaceutical companies continue to rake in huge sums for their ADHD drugs.

Last year, one of Eli Lilly’s newest drugs — the ADHD treatment Strattera — became one of its most popular as well. Sales of Strattera rocketed 80% to $667 million, far outpacing the growth posted by every other product line.

Johnson & Johnson also counts its ADHD drug Concerta, obtained through an $11.8 billion purchase of Alza in 2001, as a particularly strong performer. Even Novartis continues to make plenty of money on the old standby Ritalin.

But Shire now boasts the most popular ADHD drug of all. Last year, sales of Adderall jumped 28% — capturing one-fourth of the crucial U.S. market — as physicians wrote more and more prescriptions. Shire is now banking much of its future on ADHD as it races to bring out four new treatments for the disorder in 2005 alone.

“As the ADHD market develops, new choices of treatment are emerging,” Shire CEO Matthew Emmens recently explained. And “Shire aims to have a range of medicines in its ADHD portfolio.”

Yet some believe the ADHD drug market has already grown too large. William Pelham — a prominent researcher involved with trials of both Concerta and Adderall — says a major government study, sponsored by the National Institute of Mental Health, showed that behavioral therapy often eliminates the need for ADHD drugs altogether. During that one-year trial, he says, 75% of the children who relied on behavioral treatments functioned well without ADHD drugs. Moreover, he adds, 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 says. “I’m not saying the drugs are all bad. They’re useful for many children. But I do think they are grossly overused as a first line of intervention.”

Still, Pelham has battled to make his views known. Following the first Concerta trial, he says, Alza “wanted whole paragraphs cut out” of a journal article that highlighted the role of behavioral therapy in treatment. Pelham ultimately won his fight to retain the material, but he believes that other researchers — without his stubbornness or seniority — often feel pressured enough to back down instead.

“That pressure, whether it is subtle or not so subtle, is always something you have to deal with,” he says. “The drug companies want to emphasize medications. That is what they are selling.”

Catching Conflicts

LeFever’s research could hurt that goal.

So far, her opponents have only managed to nitpick. For example, they pounced on the wording of a single question in one of her studies even though it failed to influence her overall results. They also highlighted research that showed much lower ADHD rates instead of more recent studies that helped support her work.

Still, LeFever has felt herself battling an unimaginable force.

Russell Barkley — a high-profile expert known to embrace the ADHD drugs — emerged with his familiar argument that, if anything, even more children should be medicated for the disorder. His recent “Without Boundaries” survey was spearheaded in 2004 by the World Federation for Mental Health, in partnership with Eli Lilly.

Donald Lewis, a pediatrics professor at LeFever’s own medical school, also took aim at LeFever’s work. Lewis did not respond to a phone message from TheStreet.com. But like many researchers, he could be answering to more than one boss. The school’s directory says that Lewis actually works for nearby Monarch Research. Notably, Monarch counts dozens of drug manufacturers among its “collaborators” — including Alza, Eli Lilly, Novartis and Shire — and currently operates four clinical studies on ADHD treatments alone.

Pelham worries about potential conflicts in the industry and even points to a shortcoming in his very own work. He believes that researchers, including himself, should have disclosed their industry ties when reporting on the big NIMH study of ADHD. Right now, he says, the reports simply include a footnote — running for roughly 40 lines — about the researchers involved in the study. He says that a second footnote, exposing industry ties, would be about three times that long.

Pelham says he has tried, but failed, to see that addition made.

“I have argued for five years — on every paper — that we should have a footnote listing those relationships,” he says. “But pretty much nobody else thinks that’s necessary or important. … I always get outvoted.”

Meanwhile, LeFever fears that other researchers — influenced by their industry ties — feel compelled to halt her work.

If so, they seem to have succeeded. Late last year, LeFever says, the school abruptly placed her on administrative leave and seized the computers filled with her research. In addition, she says, the school terminated her latest ADHD project — financed by a prestigious government grant — and banned her from presenting her findings at two national conferences. Today, she says, she remains shut out of her university office and restricted from even discussing her most recent ADHD findings.

LeFever feels like the victim of powerful academic intrusions that, before, she never dreamed possible.

“This is research that’s important for the public interest and the public good, and they’re interfering with that,” she says. “It’s wrong. It’s an injustice. And it’s dangerous.”

Shaping Studies

To be fair, others have attacked more mainstream ADHD research as well.

Indeed, scientists Jonathan Leo and David Cohen offered a direct challenge. “Broken Brains or Flawed Studies?” they asked in a 2003 article published by the Journal of Mind and Behavior. They went on to tear apart some of the most powerful studies used to support the prescription of ADHD drugs. Those studies, they said, rely on imaging tests that seem to show brain differences in normal children and ADHD sufferers. But, they argued, those studies are faulty because they compare a control group with children who have already been medicated with ADHD drugs that could have actually caused the brain changes.

“After 25 years and 35 studies, there is not a single straightforward experiment comparing typical unmedicated children with an ADHD diagnosis to typical controls,” they concluded. “We are perplexed.”

Nor have scientists fully studied the long-term effects of popular ADHD drugs.

Berkeley professor Nadine Lambert offers one of the more extensive — and frightening — reports available. Lambert set out to determine whether children who take ADHD drugs go on to abuse other stimulants, such as tobacco and cocaine, as adults. She found a troubling correlation.

“Childhood use of CNS (central nervous system) stimulant treatment is significantly and pervasively implicated in the uptake of regular smoking, in daily smoking in adulthood, as well as … diagnoses of tobacco and cocaine dependence,” she wrote.

But other experts, including Barkley, have criticized those results. They call Lambert’s study flawed and highlight other research that contradicts her findings.

Andrea Arcona, a clinical psychologist and former colleague of LeFever’s, sees a pressing need for more extensive ADHD research. She says that current “long-term” studies often stretch for just a few months even though they involve drugs that may be taken by children — beginning as early as preschool — who will go on to use them for decades.

“Does it really hurt when kids start taking a drug — sometimes with other drugs — and stay on it for that long?” she asked. “Nobody knows. The research is just not out there.”

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