Elderly patients over-prescribed antipsychotic drugs

New York Post
Friday, December 02, 2011

In the United States, elderly patients with dementia are too often prescribed antipsychotic drugs to calm their disruptive behavior, a costly and risky practice that should end, experts said Wednesday
Instead, more care should be taken to determine why dementia patients may be acting up and treat those underlying causes, lawmakers were told at a hearing of the Senate Committee on Aging.
"As the baby boomer generation ages, it is imperative to address the overuse and misuse of antipsychotic drugs among nursing home patients," said Daniel Levinson, Health and Human Services Inspector General.

Levinson said recent government audits have raised concerns about the use of antipsychotics by elderly people with dementia in nursing homes, raising their risk of death and wasting money for the US healthcare system.
For instance, more than half of such prescriptions were wrongly paid for in 2007 by government Medicare because the patients did not exhibit symptoms of schizophrenia or bipolar disorder, amounting to about 230 million dollars in waste.
One audit showed 14 percent of nursing home residents had Medicare claims for antipsychotic drugs, he said.
But another panel member, Toby Edelman, senior policy attorney in the office of the Center for Medicare Advocacy, said that audit's estimate was low because it only included some kinds of anti-psychotics.
"Nursing facilities' self-reported data indicate that in the third quarter of 2010, 26.2 percent of residents had received antipsychotic drugs in the previous seven days. That is approximately 350,000 individuals," she said.
"Facilities reported they gave antipsychotic drugs to many residents who did not have a psychosis, including 40 percent of patients at high risk because of behavior issues."
Edelman also pointed out that this issue is far from new, and that the same Senate committee had issued a report on the misuse of drugs in nursing homes back in 1975, and held a workshop on the topic two decades ago.
The practice persists, even though it is against federal law, because of serious understaffing in nursing facilities, high turnover of staff, and "aggressive off-label marketing of anti-psychotic drugs," she said.
The pharmaceutical giant Eli Lilly in 2009 paid a nearly 1.5 billion dollar settlement, in which it admitted no wrongdoing, for off-label promotion of its drug Zyprexa as a treatment for dementia. The drug is FDA-approved for bipolar disorder and schizophrenia.
According to Tom Hlavacek, executive director at Alzheimer's Association's southeastern Wisconsin chapter, elderly people with dementia are sometimes prescribed these potent drugs for behaviors that have other causes.
Urinary tract infections, tooth decay, arthritic pain, or simply moving a patient from one place to another can lead to agitated behaviors.
"Our experience indicates that these care transitions can exacerbate behaviors and often lead to escalating drug treatments," he told lawmakers.
Experts said solutions could include creating stronger penalties for inappropriate prescribing, and a renewed focus on trying non-pharmacological approaches to a problem first.
"Most doctors treat unwelcome behavior in all settings as a disease that requires medication. These drugs are used as chemical restraints," said Jonathan Evans, a doctor who specializes in caring for frail elders.
"Behavior is not a disease. Behavior is communication. And in people who have lost the ability to communicate with words, the only way to communicate is through behavior," he added.
"Good care demands we figure out what they are telling us and help them."

Top Ten Legal Drugs Linked to Violence - "Time Mag"

TIME Magazine
Maia Szalavitz
January 7, 2011
When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

A new study from the Institute for Safe Medication Practices published in the journal PloS One and based on data from the FDA's Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.

Please note that this does not necessarily mean that these drugs cause violent behavior. For example, in the case of opioid pain medications like Oxycontin, people with a prior history of violent behavior may seek drugs in order to sustain an addiction, which they support via predatory crime. In the case of antipsychotics, the drugs may be given in an attempt to reduce violence by people suffering from schizophrenia and other psychotic disorders — so the drugs here might not be causing violence, but could be linked with it because they're used to try to stop it.

Nonetheless, when one particular drug in a class of nonaddictive drugs used to treat the same problem stands out, that suggests caution: unless the drug is being used to treat radically different groups of people, that drug may actually be the problem. Researchers calculated a ratio of risk for each drug compared to the others in the database, adjusting for various relevant factors that could create misleading comparisons. Here are the top ten offenders:

10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.
9. Venlafaxine (Effexor) A drug related to Pristiq in the same class of antidepressants, both are also used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior. (More on Time.com: Adderall May Not Make You Smarter, But It Makes You Think You Are)
8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence
7. Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.
6) Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.
5) Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.
4) Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain's dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.
3) Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs. (More on Time.com: Healthland's Guide to Life 2011)
2) Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.
1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it's 18 times more likely to be linked with violence compared to other drugs — by comparison, that number for Xyban is 3.9 and just 1.9 for nicotine replacement. Because Chantix is slightly superior in terms of quit rates in comparison to other drugs, it shouldn't necessarily be ruled out as an option for those trying to quit, however.

Read more: http://healthland.time.com/2011/01/07/top-ten-legal-drugs-linked-to-violence/#ixzz1DHvpV500

Placebo fraud rocks the very foundation of modern medical science; thousands of clinical trials invalidated

Thursday, October 28, 2010
by Mike Adams, the Health Ranger

(NaturalNews) You know all those thousands of clinical trials conducted over the last few decades comparing pharmaceuticals to placebo pills? Well, it turns out all those studies must now be completely thrown out as utterly non-scientific. And why? Because the placebos used in the studies weren't really placebos at all, rendering the studies scientifically invalid.

This is the conclusion from researchers at the University of California who published their findings in the October issue of the Annals of Internal Medicine. They reviewed 167 placebo-controlled trials published in peer-reviewed medical journals in 2008 and 2009 and found that 92 percent of those trials never even described the ingredients of their placebo pills.

Why is this important? Because placebo pills are supposed to be inert. But nothing is inert, it turns out. Even so-called "sugar pills" contain sugar, obviously. And sugar isn't inert. If you're running a clinical trial on diabetics, testing the effectiveness of a diabetes drug versus a placebo then obviously your clinical trial is going to make the diabetes drug look better than placebo if you use sugar pills as your placebo.

Some placebo pills use olive oil which may actually improve heart health. Other placebo pills use partially-hydrogenated oils which harm heart health. Yet only 8 percent of clinical trials bothered to list the placebo ingredients at all!

Stay with me on this placebo issue... because it gets even more bizarre...

There are no FDA rules regarding placebos in clinical trials

It turns out there are absolutely no FDA rules regarding the choice or composition of placebos used in clinical trials. Technically, a clinical trial director could use eye of newt or lizard's legs as placebo and would not even be required to mention such nefarious details in the trial results. That would cause trouble, trouble, boil and bubble! (Shakespeare reference for all you literary fans...)

We already know that clinical trials are rife with fraud. Most of the clinical trials used by pharmaceutical companies to win FDA approval of their drugs, for example, are funded by pharmaceutical companies. And it is a verifiable fact that most clinical trials tend to find results that favor the financial interests of whatever organization paid for them. So what's to stop Big Pharma from scheming up the perfect placebo that would harm patients just enough to make their own drugs look good by comparison?

Fact: Placebos are usually provided by the very same company funding the clinical trial! Do you detect any room for fraud in this equation?

How drug companies can fake clinical trials with selected placebo pills

Placebo performance strongly influences whether drugs are approved by the FDA, by the way. As the key piece of information on its regulatory approval decisions, the FDA wants to know whether a drug works better than placebo. That's the primary requirement! If they work even 5% better than placebo, they are said to be "efficacious" (meaning they "work"). This is true even if the placebo was selected and used specifically to make the drug look good by comparison.

You see, if there are no regulations or rules regarding placebo, then none of the placebo-controlled clinical trials are scientifically valid.

It's amazing how medical scientists will get rough and tough when attacking homeopathy, touting how their own medicine is "based on the gold standard of scientific evidence!" and yet when it really comes down to it, their scientific evidence is just a jug of quackery mixed with a pinch of wishful thinking and a wisp of pseudoscientific gobbledygook, all framed in the language of scientism by members of the FDA who wouldn't recognize real science if they tripped and fell into a vat full of it.

Big Pharma and the FDA have based their entire system of scientific evidence on a placebo fraud! And if the placebo isn't a placebo, then the scientific evidence isn't scientific.

Oh, but wait. They'll call it science because they wish the placebo to be a placebo. Yep -- the clinical researchers are now psychics, mediums and fortune tellers who simply decree that little pill of olive oil to "be a placebo!" while waving their hands over it in a gesture borrowed from David Copperfield.

James Randi may have never seen a psychic transmute lead into gold, but he's no doubt seen doctors transmute biochemically active substances into totally inert materials merely by wishing them so! It's so amazing!

And this brings me to the really interesting "how-to" part of this article...

How to make your own placebo just like clinical researchers do

Are you wondering how to make your own FDA-approved, scientifically validated placebo? It's easier than you think.

Step 1 - Find something shaped like a pill. It could be a pill full of olive oil, white sugar, palm oil, fluoridated water, chalk dust, synthetic chemicals or just about anything you can imagine.

Step 2 - Close your eyes and get ready to concentrate.

Step 3 - This is the important part - Repeat out loud five times while turning counter-clockwise, "I am a scientific researcher practicing evidence-based medicine!" You must say this until you really, truly believe it. If you don't believe it strongly enough, the placebo effect will be ruined.

Step 4 - Thrust your palm in the direction of the placebo pills and shout, at the top of your voice, "You are now placebo!" You may feel a shiver of energy coursing through your body. That's the power of placebo reaching out to the pills.

The process is now complete. You may now use these placebo pills in any clinical trial and expect full approval of such use by your colleagues, famous medical journals and FDA regulators. (This is not a joke. This is the state of the art today in conventional medicine.)

Hope also has a huge role to place in all this. The more you hope your placebos are really placebos, the better results you'll get. In fact, in reporting on this whole fiasco, the lead researcher of the study uncovering all this, Dr Beatric Golomb, said, "We can only hope that this hasn't seriously systematically affected medical treatment."

But of course it has. (And by the way, no disrespect toward Dr Golomb. She deserves kudos for being willing to tackle this subject which will no doubt make her very unpopular among the cult of Scientism as practiced by conventional medical researchers today.)

How to improve your clinical trial results

For improved results, try to use the most harmful placebo substances you can. For example, in real clinical trials involving AIDS patients -- who tend to be lactose intolerant -- researchers have used pills made of, guess what? Lactose!

That's sort of like running a clinical trial on a cure for heroin addiction and using heroin as the placebo, isn't it? Gee, somehow our drug worked "better than placebo." Funny how that works, isn't it?

And if you still don't get the results you want, just start inventing your own data like other clinical trial researchers do. Remember Dr Scott Reuben? This highly-respected clinical trial researcher faked at least twenty-one clinical trials for Big Pharma (http://www.naturalnews.com/028194_S...). His fraudulent clinical trials are still being cited to sell prescription medications!

Heck, who needs placebo when you can just invent the data?

Come to think of it, who needs science when you can just use anything you want and call it placebo in the first place?

Conventional medicine operates clinical trials in the same way that banks and securities firms handle mortgage documents. They all just sort of make things up as they go along, committing felony crimes on a daily basis while hoping nobody notices. On that note, check out this amazing story by Greg Hunter called The Perfect No-Prosecution Crime (http://usawatchdog.com/the-perfect-...).

Where on the skeptics when it comes to Big Pharma science fraud?

Seriously, you just gotta love the state of medical science today. I've never watched a more hilarious group of nincompoops reassure each other that they're all so scientific while practicing the most quack-ridden chicanery imaginable. The stuff being pulled off today in the name of Big Pharma's clinical trials makes psychic detectives and tarot card readers look downright scientifically gifted by comparison.

It really makes you wonder about so-called "skeptics," doesn't it? If they're skeptical of homeopathy, tarot cards, psychic mediums and people who claim they can levitate, I can at least understand the urge to ask tough questions about all these things. I ask tough questions, too, especially when people tell me they've seen ghosts or spirits coming back from the dead or other unexplained phenomena. (And I've already publicly denounced so-called "psychic surgery" which it quite obviously little more than sleight-of-hand trickery combined with animal blood.)

But most conventional skeptics never step out of bounds of their "safety zone" of popular topics for which skepticism may be safely expressed. They won't dare ask skeptical questions about the quack science backing the pharmaceutical industry, for example. Nor will they ask tough questions about vaccines, or mammography, or chemotherapy. And you'd be hard pressed to find anything more steeped in outright fraudulent quackery than the pharmaceutical industry as operated today (and the cancer branch of it in particular).

That's why I'm skeptical about the skeptics. If a skeptic doesn't question the loosey goosey pseudoscience practiced by Big Pharma, then they really have no credibility as a skeptic. You can't be selectively skeptical about some things but then a fall-for-anything fool on other scams just because they're backed by drug companies.

But getting back to this study in particular...

Abstract of the study

Here's some of the text from the abstract of this study published in the Annals of Internal Medicine (http://www.annals.org/content/153/8...)

What's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials

1. Beatrice A. Golomb, MD, PhD;
2. Laura C. Erickson, BS;
3. Sabrina Koperski, BS;
4. Deanna Sack, BS;
5. Murray Enkin, MD; and
6. Jeremy Howick, PhD

Background: No regulations govern placebo composition. The composition of placebos can influence trial outcomes and merits reporting.

Purpose: To assess how often investigators specify the composition of placebos in randomized, placebo-controlled trials.

Data Sources: 4 English-language general and internal medicine journals with high impact factors.

Study Selection: 3 reviewers screened titles and abstracts of the journals to identify randomized, placebo-controlled trials published from January 2008 to December 2009.

Data Extraction: Reviewers independently abstracted data from the introduction and methods sections of identified articles, recording treatment type (pill, injection, or other) and whether placebo composition was stated. Discrepancies were resolved by consensus.

Data Synthesis: Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002).

Limitation: Journals with high impact factors may not be representative.

Conclusion: Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

Primary Funding Source: University of California Foundation Fund 3929 -- Medical Reasoning.

Connecting the Dots Between PhRMA and Congress

National Public Radio
February 22, 2010

The initial cost-cutting deal between PhRMA and Congress would have included $30 billion in savings related to the so-called doughnut hole in Medicare prescription-drug coverage.

The initial cost-cutting deal between PhRMA and Congress would have included $30 billion in savings related to the so-called doughnut hole in Medicare prescription-drug coverage.

Earlier this month, former congressman Billy Tauzin announced that he would step down from his position as president of the pharmaceutical industry's main lobbying group, the Pharmaceutical Research and Manufacturers of America — known by the shorthand PhRMA.

Last year, PhRMA spent $28 million lobbying in favor of a health care overhaul, after negotiating a deal with the White House and members of Congress. In that deal, the pharmaceutical industry pledged to reduce health care costs by $80 billion over 10 years.

By negotiating the secret deal, writer Paul Blumenthal explains, "the Obama administration got the biggest lobby in Washington and put them on the side of health care reform." Meanwhile, the pharmaceutical industry got a guarantee that "Congress would not legislate any cost-cutting measures that would make a dent in industry profits."

Blumenthal, a senior writer at the Sunlight Foundation, determined that Congress and PhRMA met dozens of times to negotiate that deal. He tells Terry Gross that he learned who attended the meetings by examining Federal Election Commission records, public visitor logs to the White House and the publicly available schedule of Sen. Max Baucus, the chairman of the Senate Finance Committee.

"The major people are President Obama, [Chief of Staff] Rahm Emanuel and Jim Messina," Blumenthal says. "Jim Messina is the former chief of staff and campaign manager to Sen. Max Baucus. You see Jim Messina pop up in meetings between pharmacy CEOs."

Blumenthal says that the CEOs of pharmaceutical giants Pfizer and AstraZeneca attended a series of meetings at the White House throughout the spring and summer, and agreed to spend more than $150 million on ads touting a health care overhaul. That spending and the subsequent lack of progress on the bill, Blumenthal notes, may be why Tauzin resigned.

"One of the key things to look at is the fact that pharmaceutical companies dumped $100 million to $150 million on ads and haven't gotten what they paid for," says Blumenthal. "They're not thrilled that they spent [that money] in ads, and this isn't going to pass."

Jurors outraged by psychiatrist's conduct Felt she should share culpability in toddlers death

By Patricia Wen
Globe Staff
February 11, 2010

BROCKTON - The jury that convicted a South Shore woman this week of killing her 4-year-old daughter with an overdose of psychotropic drugs was also outraged by the conduct of the child’s psychiatrist and hoped the doctor would be held responsible in some way for the girl’s death, according to several jurors interviewed a day after the verdict.

“Every one of us was very angry,’’ said one juror, who requested anonymity to avoid retaliation for her role in Tuesday’s second-degree murder conviction of Carolyn Riley. “Dr. Kifuji should be sitting in the defendant’s chair, too.’’

Another juror said that while the 12-member panel found that the 35-year-old mother was primarily responsible for Rebecca’s death, many jurors were “off the wall’’ when they heard the testimony of Dr. Kayoko Kifuji of Tufts Medical Center. She said they were struck by how quickly Kifuji diagnosed Rebecca with bipolar and hyperactivity disorders, as well as how little the doctor seemed to supervise the mother’s dispensing of medications.

“It blew me away,’’ said that juror, who asked to remain unidentified for fear of reprisals.

Rebecca’s psychiatrist was the focus of some of the most powerful reactions from the jurors after a three-week trial that left them emotionally and physically exhausted.

While Kifuji’s attorney defended the psychiatrist and said jurors saw “only pieces of the full extent of diagnosis and treatment’’ of the girl, several jurors said they feel Kifuji bears some responsibility for the child’s overdose of psychiatric drugs, which were dispensed by a troubled mother.

Kifuji is facing a medical malpractice case filed by the estate of Rebecca Riley, though that case is not expected to go to trial for at least a year.

Other than the nationwide publicity given to the Riley case, in which Kifuji is mentioned repeatedly, the only overt sign that Kifuji had potentially questionable conduct is on the Board of Registration of Medicine’s website.

In a section dealing with disciplinary matters, the website lists the dates, from February 2007 to September 2009, in which Kifuji started and was permitted to end a “voluntary agreement’’ to stop practicing psychiatry.

Still, when asked if the board’s investigation concluded that Kifuji acted within acceptable medical standards, spokesman Russell Aims responded by saying that the board “closed the complaint against Dr. Kifuji without discipline.’’ He said the board, however, “reserves the right to reopen a case if new information comes to light.’’

The psychiatrist will not face criminal prosecution. A grand jury last summer declined to indict her, and Kifuji testified in Carolyn Riley’s trial only after being granted immunity from prosecution.

With her Boston attorney, Bruce Singal, at her side in court, Kifuji had initially declined to testify by invoking her right against self-incrimination. That move forced the government to grant her immunity as the only way to compel her to testify.

Singal defended the 55-year-old psychiatrist, saying by e-mail yesterday that her treatment of Rebecca has been “reviewed and cleared on numerous levels.’’ He said a Tufts Medical Center review found her care appropriate.

Singal went on to say that he is confident that any thorough examination of the doctor’s care of Rebecca would show she acted “in the best interests of this seriously ill child, and diagnosed and treated her in full accord with acceptable medical standards.’’

Several jurors in the mother’s trial said they never questioned whether Carolyn Riley was culpable, and an acquittal was never a possibility. When faced with a choice between first-degree murder and two lesser options of second-degree murder and manslaughter, the panel was divided.

Throughout much of their discussions, roughly half the members tilted toward a conviction of first-degree murder, one juror sought a manslaughter conviction, and the rest were focused on a second-degree murder conviction, according to a third juror, who also asked to remain anonymous.

Jurors wrestled over the meaning of “malice,’’ a condition they felt was necessary for a murder conviction but not for manslaughter. Ultimately, they decided the mother acted with malice through her routine use of pills to sedate her toddler, and her dispensing of toxic levels of clonidine in the hours before the girl died on Dec. 13, 2006. They united on a second-degree murder conviction, instead of a first-degree murder conviction, as a compromise.

The jurors said that during the 19 hours of deliberations behind closed doors, many wept while looking at photos of the girl’s body on the floor next to her parents’ bed. They said everyone felt the girl had pneumonia, but that she would not have died without dangerous levels of drugs in her body.

Patricia Wen can be reached at wen@globe.com
© Copyright 2010 Globe Newspaper Company.

Vermont Acts to Make Drug Makers' Gifts Public

New York Times
By NATASHA SINGER
Published: May 19, 2009

Cracking down on medical industry payments to doctors, the Vermont legislature has passed a law requiring drug and device makers to publicly disclose all money given to physicians and other health care providers, naming names and listing dollar amounts.

The law, scheduled to take effect on July 1, is believed to be the most stringent state effort to regulate the marketing of medical products to doctors. It would also ban nearly all industry gifts, including meals, to doctors, nurses, medical staff, pharmacists, health plan administrators and health care facilities.

In practice, the new law would let Vermonters learn each year which doctors have been paid, and how much, by the makers of the brand-name drugs for which they wrote prescriptions — or how much money certain surgeons have received from the makers of the stents, pacemakers, artificial knees and such that the doctors implanted.

The action by Vermont has been watched around the country, as national legislators and medical groups look for links between industry marketing and health care costs.

Minnesota already requires drug companies to report payments to doctors. New Massachusetts regulations limit gifts to health care practitioners and call for disclosure of any payment or benefit worth $50 or more.

In Congress, Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin, have sponsored a bill requiring disclosure of pharmaceutical industry payments to doctors.

But Vermont has gone further with its new law, which Gov. Jim Douglas, a Republican, is expected to sign by early next month. It will require public disclosure of all payments by companies to any health care provider with authority to write prescriptions for drugs, medical devices and biologics, drugs that are typically administered by injection or infusion.

The law is also the first to ban all free meals, long a favorite gift in marketing to doctors. The law also closes a loophole in previous regulations that had allowed companies to keep specific expenses private by claiming them as trade secrets.

The required disclosures, though, do not include payments for clinical research on products under review by the Food and Drug Administration.

"This is a much more comprehensive law because it makes clear — whether devices, biologics or drugs are involved — the issue is inappropriate gift-giving," said Sharon Treat, the executive director of a nonprofit group, the National Legislative Association for Prescription Drug Pricing, and a Democrat in the Maine House of Representatives.

The Vermont law promises to provide a window into the considerable efforts and spending by device and drug makers to woo doctors even in a small state.

Makers of medical products spent about $2.9 million in fiscal year 2008 on marketing to health care professionals in Vermont, according to a report last month from the state's attorney general. Of Vermont's 4,573 licensed health practitioners, almost half received remuneration, including payments for lectures, meals or lodging from pharmaceutical companies in the 2008 fiscal year, the report said.

"If the drug industry gives $3 million on average for three years now to physicians in a small state like Vermont, what is happening in California and New York?" said Ken Libertoff, director of the Vermont Association for Mental Health, an advocacy group that supported the law.

The Vermont attorney general's report, compiled before passage of the law, provides only aggregate data because companies declared 83 percent of the payments to be trade secrets. Even so, without naming names, the disclosed expenses highlighted a widely used industry strategy of focusing much of the marketing money on a group of influential doctors.

Of the $2.9 million spent in Vermont, for example, about $1.8 million went to only 100 health care providers. That meant only about 4 percent of doctors received 60 percent of the payments, the report said.

A psychiatrist received about $112,000, the highest amount spent on one person. But specialists in internal medicine, neurology, endocrinology and diabetes also received more than $100,000 each during the year.

To reduce the perception of undue industry influence, the Pharmaceutical Research and Manufacturers of America or PhRMA, a trade association, instituted a voluntary code in January that prohibits noneducational gifts to doctors and restricts meals. About 50 manufacturers the code.

With such a code, Vermont's new reporting requirements seem redundant, said Marjorie E. Powell, a senior lawyer for PhRMA.

"We think this is unnecessary, and it is not going to improve patient care," Ms. Powell said. "It makes it onerous not only for the company but also for the physician in Vermont, because this is going to be on a Web site."

But the Vermont Medical Society, which represents 65 percent of the physicians in the state, supported the bill.

Peter Shumlin, president pro tempore of the Vermont state senate, said he hoped his state would provide a model on marketing disclosures for the rest of the country.

"Our goal is not to prohibit this practice," Mr. Shumlin said, "but to have the first system in this country where providers' acceptance of this money is on full public record."

Children's Use Of Psychiatric Drugs Begins To Decelerate

The Wall Street Journal
By David Armstrong
May 18, 2009

The growth in antipsychotic-drug prescriptions for children is slowing as state Medicaid agencies heighten their scrutiny of usage and doctors grow more wary of the powerful medications.

The softening in sales for children is the first sign that litigation, reaction to improper marketing tactics, and concern about side effects may be affecting what had been a fast-growing children's drug segment.

The six so-called atypical antipsychotics that dominate the market have limited approval from the FDA to treat patients under 18 years of age. Only one is cleared for children under age 10 -- risperidone, branded by Johnson & Johnson as Risperdal -- to treat irritability associated with autism.
[psychotic drugs for kids]

But doctors can prescribe drugs as they see fit, and many have turned to the atypicals to treat serious mental conditions in children, including schizophrenia and bipolar disorder. Use of Risperidone by those 18 and under accounts for about 25% of the drug's sales, while SDI Health, a medical market-research company that gathers sales information from drugstores, estimates that sales of all antipsychotics to that age group account for 15% of the drugs' sales, or $2.18 billion.

Data on use among children are hard to come by, but SDI's figures show that antipsychotic prescriptions for children under 18 rose 5.2% between 2007 and 2008, compared with an increase of 8.73% in the year-earlier period.

The slowdown is more pronounced among younger children. The nation's second largest pharmacy-benefits manager, Medco Health Solutions Inc., which handles 586 million prescriptions a year, estimates that prescriptions for antipsychotics for patients under 10 fell 4% last year. From 2001 through 2007, use in that age group increased 85%, Medco says.

SDI Health estimates that prescriptions for psychiatric drugs for children under 10 increased 3.5% last year. In contrast, between 2002 and 2007, such prescriptions rose 44.6%, it says. SDI also says it saw a 1% drop in prescriptions for those under seven last year.

"I was never a big prescriber to begin with, but I have definitely been more careful as information has come to light about the serious side effects being downplayed in the marketing of these drugs," says Michael Houston, a child psychiatrist in Chevy Chase, Md.

Others who treat children with serious and dangerous behavioral problems worry that misconceptions about the drugs will prompt some parents or doctors to balk at their use.

"For those children who are seriously mentally ill, although these side effects can be potentially significant, the benefits far outweigh the side effects," says Louis Kraus, the chief of child psychiatry at Rush University Medical Center in Chicago.

Antipsychotics have faced heightened scrutiny and investigation over the past year. In November, a Food and Drug Administration advisory committee asked the FDA to research children's use of the drugs and expressed concern about possible side effects such as weight gain and increased diabetes risk. And 11 state attorneys general are investigating alleged marketing of Eli Lilly & Co.'s antipsychotic Zyprexa for uses the FDA hasn't approved.

In January, Eli Lilly agreed to pay $1.4 billion to settle allegations it improperly marketed Zyprexa. The company also agreed to plead guilty to a criminal charge of promoting the drug for unapproved uses.

A Lilly spokesman declined to comment on ongoing litigation and said the company doesn't track the drug's use in children.

Bristol-Myers Squibb Co. agreed to pay $515 million in September 2007 to settle allegations it promoted Abilify for use in children. The FDA didn't approve of the use of the drug in children older than 10 until 2008.

State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, includingan antipsychotic, court records show.

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.