Tuesday, September 27, 2005

FDA Footdragging Attacked Re Prozac, Paxil

According to a story on U.S. Newswire, 125 medical practitioners have signed onto a joint letter to the U.S. Food and Drug Administration (FDA), renewing a call to take immediate action on issuing stronger warnings for antidepressant and stimulant drugs, as a 3-day protest rages by consumer groups demanding Glaxo recall its $950 million antidepressant Paxil. The same letter, sent to FDA Commissioner Lester Crawford in July, 2005 and signed by 20 doctors, was left unanswered by the Commissioner prompting many to accuse the FDA of bureaucratic foot-dragging and procrastination. Senator Charles Grassley, (R-Iowa) who has spent months investigating the FDA, said the agency "demonstrated a too-cozy relationship with the pharmaceutical industry," and that "the opportunity to name a new commissioner is a chance to take the agency in the right direction."

The doctors' letters join recent efforts by Dr. Ann Blake Tracy, Executive Director of the International coalition for Drug Awareness (ICFDA) and Mrs. Bonnie Leitsch, founder of "Prozac Survivors Support Group" (PSSG) in calling for immediate federal action to warn the public that antidepressants can not only induce suicidality in adult patients - but also acts of violence, pointing out that the U.S. FDA has known of these effects since a 1991 public hearing on antidepressant drugs. Prompted by a spate of recent incidents of mothers murdering their own children while taking antidepressants, Dr. Tracy said, "These are extremely dangerous drugs that should have been banned, as similar drugs were in the past. Federal investigations into the violence- inducing effects of these drugs are long overdue." Mrs. Leitsch added, "In 1991, there was evidence of 500 deaths associated with antidepressants presented to an FDA Psychopharmacological Drugs Advisory Committee hearing investigating Prozac. The FDA's failure to issue timely warnings then has led to more suicides, homicides, school shootings and mothers killing their own children."

Concerned doctors are also pushing for FDA reform and action under new leadership. 25 European countries recently warned that antidepressants should not be used in patients under 18 due to the suicide and violence inducing effects of the drugs and recent clinical studies linked ADHD drugs to hallucinations, violence, psychosis, and suicide. Dr. Julian Whitaker, M.D., and principal author of the letter says the overwhelming evidence of the dangers of these drugs makes further FDA procrastination unacceptable, "It is beyond debate that these drugs have extremely dangerous side effects and that the public is not being kept adequately informed about these dangers," states Whitaker, "It is our hope that the new Commissioner will take immediate and swift action to protect the public from these dangerous and too often deadly psychiatric drugs."

Fueled by $4.5 billion in direct consumer advertising, ADHD stimulant drug sales have quadrupled since 2000 while antidepressant sales have passed the $20 billion mark, prompting many to question how profit-driven vested interests may be involved in the FDA's failure to warn patients of the drugs risks. "With literally billions of dollars of profits at stake, we are not surprised when we hear stories of skewed clinical trials, suppressed study outcomes, pressure placed on reviewers, and a host of other abuses," stated Dr. Whitaker.

Monday, September 26, 2005

Rock Icons Attack Ritalin

This L.A. Times article hits the nail on the head.

A Prescribed Threat

By Mary Eberstadt

MARY EBERSTADT is a research fellow at the Hoover Institution and author of "Home-Alone America," newly released in paperback by Penguin/Sentinel.

September 25, 2005

WHEN TOM CRUISE and his fellow Scientologists took a hammering earlier this year for their public opposition to psychiatric drugs, neither they nor their critics could have anticipated the releases in July and August of two weighty reports offering evidence that at least some psychiatric prescription-writing has run amok.

If these two reports by Columbia University's National Center on Addiction and Substance Abuse, or CASA, have it right, more kids than ever have their fingers — and sometimes their noses — in somebody else's psychiatric prescription pill bottle.

The July report ("Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S.") estimates that while self-reported use of prescription drugs by people of all ages nearly doubled between 1992 and 2003, abuse by teenagers during those years tripled.

Similar increases appear in the August report, "National Survey of American Attitudes on Substance Abuse X: Teens and Parents." Between April 2004 and June 2005, for example, "the percentage of teens who know a friend or classmate who has abused prescription drugs jumped 86%."

In his introduction to the July report, CASA Chairman and President Joseph A. Califano Jr. zeroes in on the problem: "Particularly alarming is the 212% increase from 1992 to 2003 in the number of 12- to 17-year-olds abusing controlled prescription drugs, and the number of teens trying these drugs for the first time."

Nor does Califano sugarcoat the question of just how close to home the problem hits: "The explosion in the prescription of addictive opioids, depressants and stimulants has, for many children, made the medicine cabinet a greater temptation and threat than the illegal street drug dealer, as some parents have become unwitting and passive pushers."

At a time when many doctors, teachers and parents swear by the beneficial effects of prescription stimulants for minors, words as unsparing as Califano's are likely to be dismissed as alarmist.

But these reports are not the only evidence of the harm done by these drugs to at least some kids. If we look at what kids say, sing and report about psychiatric medications, we learn that among the harshest critics of the child wonder-drug regimen are some of its intended beneficiaries and graduates.

Consider two music icons. The late grunge-rock guru Kurt Cobain appears in retrospect as a kind of anti-poster boy for child stimulants. Prescribed Ritalin from the age of 7, Cobain believed that the drug led to his later abuse of related substances. (He committed suicide by shotgun in 1994.)

Cobain's widow, Courtney Love, put the connection this way to biographer Charles R. Cross: "Kurt's own opinion, as he later told her, was that the drug was significant. Courtney, who also was prescribed Ritalin as a child, said: 'When you're a kid and you get this drug that makes you feel that [euphoric] feeling, where else are you going to turn when you're an adult?' "

Marshall Mathers, a.k.a. bad-boy rap superstar Eminem, is another prominent self-perceived child victim of the label-and-medicate momentum. In an article in Rolling Stone magazine, Howard Stern said that Eminem told him that his mother "misdiagnosed him with attention deficit disorder. 'My mother said I was a hyper kid, and I wasn't,' he said. 'She put me on Ritalin.' " One telling Eminem hit called "Cleaning Out My Closet" includes the lyric, "My whole life I was made to believe I was sick when I wasn't."

It seems almost too perverse to be true: Cobain's and Eminem's fans might get a stronger anti-stimulant message from their icons' examples than from their own parents, teachers and doctors.

Criticism of the child-drug phenomenon also comes from writers who self-identify as members of "the Ritalin generation." One is Elizabeth Wurtzel, author of the books "Prozac Nation" and "More, Now, Again." The latter detailed her harrowing descent into Ritalin addiction after a well-meaning doctor prescribed the drug to help her "focus" on writing.

Advocates of psychiatric medication for children often argue, and passionately, that these drugs alleviate the suffering of many children and families. But if that positive experience is to be a legitimate test, so too should the negative feelings and experiences of others be acknowledged.

"These [stimulants] are very safe medications," a child psychiatrist at Harvard Medical School told a reporter in the wake of the July CASA report. "They have been used for 70 years, and we haven't had terrible catastrophes."

Yet it doesn't take a Scientologist to wonder whether "terrible catastrophe" is the most accurate measurement.