Friday, June 29, 2007

Lilly May Face More Zyprexa Lawsuits After FDA Letter

 
Bloomberg News
Lilly May Face More Zyprexa Lawsuits After FDA Letter
By Rob Waters and Margaret Cronin Fisk
June 29, 2007
 
 
 

June 29 (Bloomberg) -- Eli Lilly & Co. may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from U.S. regulators.

The U.S. Food and Drug Administration told Lilly in March it would delay the approval of Symbyax for depression because the agency wanted more information about the risk of diabetes in the medicine's prescribing label. Symbyax combines Lilly's antipsychotic pill Zyprexa and the antidepressant Prozac.

The FDA's request, in a letter to Lilly obtained by Bloomberg, may bolster plaintiffs' suits against the Indianapolis company over side effects tied to Zyprexa, lawyers said. Lilly has paid more than $1.2 billion to settle 29,000 claims that patients weren't adequately warned that Zyprexa can cause diabetes, weight gain and pancreas infections.

``When the FDA says something damning about the warnings of a drug, it's admissible as evidence on the reasonableness of the manufacturer's decisions,'' said David Logan, dean of the Roger Williams University School of Law in Bristol, Rhode Island, in an interview. ``It would likely carry some weight with juries.''

Logan isn't involved in Zyprexa litigation and hasn't been an expert witness in product-defect lawsuits.

In addition to the individual claims, at least eight states have sued the company on behalf of their Medicaid health programs for the indigent, alleging Lilly concealed risks and marketed the drug for unapproved uses.

Studies have shown that Zyprexa and other, similar medications known as atypical antipsychotics are associated with weight gain and an increased risk of diabetes. These studies prompted the FDA to require Lilly and other drugmakers to warn doctors of the risks in September 2003 and again in March 2004.  

More here: http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a_m6PfnY8YA0

 

...

Thursday, June 28, 2007

APA Financial Ties to Drug Firms

"Last year's meeting of the American Psychiatric Association in Toronto, the field's biggest educational conference, reflects the extent of corporate sponsorships. In the meeting program, a voluntary listing of the financial ties to drug firms of the physicians who served as instructors covered 14 pages. Some instructors were sponsored by at least a dozen companies."

Washington Post
Conflict Alleged in Drug Firms' Education Role
June 27, 2007

Drug companies have become the biggest sponsors of continuing medical education courses in recent years, even at the nation's top medical schools, a development that critics say raises health-care costs, skews doctors' treatment decisions and allows the industry to skirt laws against advertising "off-label" uses for its products.

The trend accelerated after the government backed off a plan to limit commercial sponsorships in 2002 at the urging of the industry, Senate investigators said.

Now, nearly two-thirds of the cost of continuing education courses sponsored by medical schools, popular for their prestige, are paid for by drug and medical device companies and other commercial interests, figures show. Overall, commercial sponsors pick up about half of the $2.25 billion annual cost of the courses doctors must attend to keep their licenses.

"Most of what doctors know about drugs comes from the industry, and that's not healthy," said Jerry Avorn, a Harvard Medical School professor and critic of the sponsorships. "Academic organizations lend their names to courses that are nothing more than infomercials." 

 More here: http://www.washingtonpost.com/wp-dyn/content/article/2007/06/26/AR2007062601963.html?nav=rss_print/asection

 

 

...

Psychiatry - No Evidence

http://www.clinicalpsychiatrynews.com/article/PIIS0270664407703478/fulltext

Clinical Psychiatry News

Evidence has to be clinically relevant.

DR. MICHELS is professor of medicine and psychiatry at Cornell University, Ithaca, N.Y.

Our current evidence base in psychiatry is not totally irrelevant to the clinical task of treatment planning and selection. But it comes dangerously close.

What has been offered as evidence is only data. Evidence is data that are useful in making decisions. Much, probably most, of the data available about treatment in psychiatry fails that test in the clinician's office.

The treatments that are studied are only a portion (and a strongly biased portion) of the available array of treatments. The treatments chosen for study by the sponsoring industries or by academics aren't the ones that are of greatest clinical importance. Consequently, we have evidence neither for nor against many of the most popular treatments in contemporary psychiatry. We have a huge number of data about treatments that have little public health value.

Most of the studies are sponsored by industries or commercial organizations that have an interest in the outcome of the study. Extensive research--evidence, if you want to call it that--has demonstrated that sponsored studies are consistently biased, and therefore not desirable as resources for making decisions.

Most of the studies in the literature use control groups that rarely are treated with the optimal alternative to the treatment being investigated. Instead, they use as the comparison treatment "as usual" in the community. They neither select the best practitioners in the community nor give them the best resources. Any treatment provided by enthusiastic researchers can be "treatment as usual."

Patients in most studies are highly selected and often atypical. Studies usually rule out patients with comorbid disorders. Do the patients who enter your offices arrive without comorbidity?

Frequently, the treatment duration studied is inadequate and the follow-up so short that it is almost irrelevant to the clinical problems. The patients we treat in our offices have intermittent and recurring disorders that persist for years. The treatments we use ought to be evaluated on the basis of their long-term impact on the course of the illness, not on their short-term effects on acute symptoms.

Standard outcome measures are much too narrow, usually focusing on the diminution of presenting symptoms rather than on global function. For example, we have reams of data showing the "efficacy" of drugs in reducing the positive symptoms of schizophrenia in acute episodes, but few data about the more devastating problems patients face--their long-term functioning, neurocognitive deficits, and secondary symptoms.

A recent analysis of depression treatment studies suggested that the quality of the therapeutic relationship between the treater and the patient, and the patient's pretreatment personality, were both more important in determining outcome than the specific treatment delivered. In a treatment study designed to investigate specific therapy A vs. specific therapy B, you're going to get something that's data at the end of the study, but not something that's evidence.

We need evidence relevant to clinical decision making. We don't have that evidence yet. In the current setting, we don't have much chance of getting it. We need science-based psychiatrists and evidence-based clinical judgment rather than rhetorical slogans about evidence-based treatments.

 

...

A dose of influence?

A dose of influence?
Drug makers fund MDs' seminars but deny pressure


By: JOHN RUSSELL
Dr. Daniel Carlat, a Massachusetts psychiatrist, says it usually takes him no longer than 60 seconds of sitting through a medical education session to guess which pharmaceutical company sponsored it.

If the program highlights the findings of a recent national drug trial that concluded that Zyprexa was more effective in treating schizophrenia than other medications, but otherwise plays down the drug's metabolic side effects, he can guess that Eli Lilly and Co. paid for the program.

On the other hand, if the symposium does not mention that particular drug trial favorable to Zyprexa, but discusses the weight-gain side effects of certain drugs, he can guess that Pfizer, maker of rival antipsychotic Geodon, sponsored the session.

"It's kind of a nudge, nudge, wink, wink situation," said Carlat, an assistant clinical professor of psychiatry at Tufts University in Boston.

"Everybody in the field knows what's happening, but the official talk goes on as though everything is fine," added Carlat, who recently started a blog criticizing the relationship between the drug industry and continuing medical education for doctors.

More here: http://www.indystar.com/apps/pbcs.dll/article?AID=2007706240319


...

Psychiatrists Top List in Drug Maker Gifts - NYTimes

 
June 27, 2007

Psychiatrists Top List in Drug Maker Gifts

WASHINGTON, June 26 -- As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty.

How this money may be influencing psychiatrists and other doctors has become one of the most contentious issues in health care. For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved.

Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state's Medicaid program.

Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.

The number most likely represents a small fraction of drug makers' total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them.

"For the fourth year in a row, our analysis shows that there is a great deal of money being spent in our small state on marketing pharmaceutical products," said William H. Sorrell, the Vermont attorney general.

Endocrinologists received the second largest amount, according to the Vermont analysis, earning an average of $33,730. Since the state identified the specialties of only the top 100 earners, these averages represent the money earned by only some of the state's specialists. There were 11 psychiatrists and 5 endocrinologists in that top group of 100.

Still, a similar pattern was evident in a Minnesota database that was the subject of a series of articles in The New York Times this year. As in Vermont, psychiatrists earned on aggregate the most in Minnesota, with payments ranging from $51 to $689,000. The Times found that psychiatrists who took the most money from makers of antipsychotic drugs tended to prescribe the drugs to children the most often.

These and other stories have helped to fuel a growing interest among state and federal officials to document and restrict payments to doctors from drug makers. At a gathering last month at Columbia Law School in New York, state attorneys general from across the country discussed ways to get similar data for their states.

And today, the Senate Special Committee on Aging, which is led by Senator Herb Kohl, Democrat of Wisconsin, will hold the first of a series of hearings on the issue, which could lead to legislative proposals to restrict and require disclosure of payments and gifts to doctors from drug companies nationwide.

Several lawmakers on Capitol Hill have expressed interest in such legislation, including Senator Charles E. Grassley, Republican of Iowa. "A federal law requiring public disclosure of payments to doctors could be very effective if it was carefully monitored and consistently applied," Mr. Grassley said.

Efforts to require disclosure of payments to doctors began almost by happenstance in 1993, when The Minnesota Legislature passed a law that restricts drug companies from giving doctors gifts valued at more than $100 in any given year. The legislation also required companies to report and make public any consulting fees paid to doctors.

Lee Greenfield, a former state representative in Minnesota and one of the law's authors, said it passed with little fanfare or debate after legislators heard stories about doctors accepting gifts of great value from drug makers.

"Why do we want them bribing doctors to use what may not be the best or most cost-effective drug for the patient purely to get some hand-held TV, we all asked," Mr. Greenfield said.

Still, compliance with the law has been spotty. Some companies never responded to the board's requests for disclosures. Others did so fitfully. A few sent letters saying they did not collect that information and thus could not provide it.

Minnesota officials never cracked down. Such reports were put in file drawers and largely forgotten until this past year, said Cody Wiberg, executive director of the Minnesota Board of Pharmacy. Mr. Wiberg said he planned this year to pursue companies that fail to report.

Besides Vermont and Maine, more than a dozen other states have or are now considering similar legislation, said Sharon Anglin Treat, executive director of the National Legislative Association on Prescription Drug Prices.

Officials in Maine and Vermont said they would try to compare reports of payments to doctors with Medicaid records to explore how marketing practices might influence prescribing by doctors in ways that increased costs to taxpayers.

"What we want to be able to do is overlay the prescribing information that we have with the drug detailing information," said Jude Walsh, special assistant to the governor of Maine, John E. Baldacci. "If we see that doctors in a certain southern county in the state are prescribing a lot of a drug and getting a lot of detailing for that drug, that could lead to some record reviews to see what's happening."


 

...

APA Financial Ties to Drug Firms

"Between a third and a half of medical providers have a relationship with industry," said Jerome P. Kassirer, a professor at Tufts University's School of Medicine and the author of a book about the financial links between doctors and drug companies. "These are promotional activities disguised as education."

http://www.washingtonpost.com/wp-dyn/content/article/2007/06/26/AR2007062601963.html?nav=rss_print/asection

Washington Post
Conflict Alleged in Drug Firms' Education Role
June 27, 2007

Drug companies have become the biggest sponsors of continuing medical education courses in recent years, even at the nation's top medical schools, a development that critics say raises health-care costs, skews doctors' treatment decisions and allows the industry to skirt laws against advertising "off-label" uses for its products.

The trend accelerated after the government backed off a plan to limit commercial sponsorships in 2002 at the urging of the industry, Senate investigators said.

Now, nearly two-thirds of the cost of continuing education courses sponsored by medical schools, popular for their prestige, are paid for by drug and medical device companies and other commercial interests, figures show. Overall, commercial sponsors pick up about half of the $2.25 billion annual cost of the courses doctors must attend to keep their licenses.

"Most of what doctors know about drugs comes from the industry, and that's not healthy," said Jerry Avorn, a Harvard Medical School professor and critic of the sponsorships. "Academic organizations lend their names to courses that are nothing more than infomercials."

But Scott Lassman, senior assistant general counsel at Pharmaceutical Research and Manufacturers of America, said industry funding of continuing medical education is a great way to educate physicians about the latest medical and scientific research.

The courses "are viewed as running independently of the pharmaceutical company," Lassman said. "The company may be providing the funding for it, but they are not directing the content."

He also defended the practice of discussing off-label uses for drugs -- uses not approved by the Food and Drug Administration -- in the courses. "A lot of times, the regulatory process lags behind the science," he said. "I think it's a benefit for physicians, as long as it's independent and as long as the scientific information is solid."

For doctors, though, drug company funding "makes it very difficult to know what research to believe," said J. Gregory Rosenthal, an Ohio retinal surgeon and a founder of Physicians for Clinical Responsibility, a group pushing for tighter controls on conflicts of interest in medicine. "Even at the [specialty] academy level, you can't go onto a Web site without being confronted by sponsorship logos."

Rosenthal will testify today in a hearing before the Senate Special Committee on Aging, which is looking into physician links with the drug industry. Sen. Herb Kohl (D-Wis.), the chairman, said the commercial sponsorship of courses creates a conflict of interest.

"It appears that everyone profits from this pervasive system of gifts and payments, except the consumer," Kohl said.

The hearing marks the second time this year that the Senate has examined the independence of industry-sponsored continuing education. In April, a Senate Finance Committee study found that the Accreditation Council for Continuing Medical Education, the main accrediting body for education providers, does not scrutinize course materials for accuracy or evidence of bias toward sponsors' products. At times, sponsors have been able to select topics, and presenters have discussed off-label uses for drugs, the report found.

"There has to be a bright line between drug company spending on medical education and spending on marketing," Sen. Max Baucus (D-Mont.), the committee's chairman, said in remarks echoed by Charles E. Grassley of Iowa, the panel's top Republican.

Murray Kopelow, chief executive of the accrediting council, acknowledged that concerns over the drug industry's influence persist despite the advent of stricter oversight and ethical guidelines. "We've done a lot, but we believe we could do more in putting into place detection systems and monitoring systems in order to provide data to address those concerns," Kopelow said.

He said the drug industry does hold some sway over which topics are covered in the courses.

"Commercial interests fund educational activities that are consistent with their business," he said. "To that extent, the industry has some control over the topics that are taught. The title of the activity would not be in the hands of the commercial interest but would be in the hands of the accredited provider."

Last year's meeting of the American Psychiatric Association in Toronto, the field's biggest educational conference, reflects the extent of corporate sponsorships. In the meeting program, a voluntary listing of the financial ties to drug firms of the physicians who served as instructors covered 14 pages. Some instructors were sponsored by at least a dozen companies.

"Between a third and a half of medical providers have a relationship with industry," said Jerome P. Kassirer, a professor at Tufts University's School of Medicine and the author of a book about the financial links between doctors and drug companies. "These are promotional activities disguised as education."

In 2002, after identifying prescription drugs as the biggest factor in soaring federal health-care costs, the inspector general's office at the Department of Health and Human Services drafted tighter rules governing industry sponsorship of the courses, according to the Senate aging committee. Soon after, however, lawyers for the industry hand-delivered a 56-page memo objecting to the draft, and the guidelines the government eventually adopted closely matched the industry's voluntary code of ethics.

Some states have begun looking into the issue. In Pennsylvania, for example, Avorn, the Harvard professor, helped create RxFacts ( http://www.rxfacts.org), a two-year-old program that provides physicians with evidence-based, noncommercial prescription information.

"I don't think we ever can or should prevent companies from making honest statements about their approved products," Avorn said. "But we need to give doctors a chance to hear from people who don't have products to sell."

 

...

ScienceDaily: Antidepressants Linked To Bone Loss, Study Suggests

 

Antidepressants Linked To Bone Loss, Study Suggests

Science Daily -- Two new studies suggest older men and women taking selective serotonin reuptake inhibitors, a class of antidepressants that includes Prozac, Paxil and Zoloft, are prone to increased bone loss.

The jointly released studies by scientists at Oregon Health & Science University, and in San Francisco, Minneapolis, San Diego and Pittsburgh, found that elderly men taking the so-called SSRIs had lower bone mineral density, and that elderly women taking the antidepressants had a higher rate of yearly bone loss.

The studies "raise some concern about people taking SSRIs and whether they may need additional screening or extra protection for their bones," said Elizabeth Haney, M.D., assistant professor of medicine (general internal medicine and geriatrics) in the OHSU School of Medicine who led the men's study and co-authored the women's study.

But Haney cautioned the studies' results don't confirm a "cause-and-effect relationship" between SSRIs and bone loss. "Both are observational studies, so without a prospective study of this issue, we're unable to make a determination of direct causality," she said.

The studies also found that use of another popular class of antidepressant medications, known as tricyclic antidepressants or TCAs, were not associated with increased bone loss in men and women. TCAs include such drugs as amitriptyline (Elavil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil) and nortriptyline (Pamelor).

For the men's study, which measured total bone loss, researchers analyzed health data for 5,995 men ages 65 and older who were recruited from six regions of the United States between March 2000 and April 2002. They found that bone mineral density among SSRI users was 3.9 percent lower at the total hip and 5.9 percent lower at the lumbar spine compared with men not taking the antidepressants.

For the women's study, a longitudinal study measuring bone loss rate, researchers first examined 2,722 women ages 65 and older from four regions between 1986 and 1988, and again between 1997 and 1998. Bone mineral density in the total hip decreased .47 percent among participants who didn't use SSRIs, but .82 percent among people who did take the drugs.

Michael Bliziotes, M.D., OHSU associate professor of medicine (endocrinology, diabetes and clinical nutrition) who was senior author on the men's study and co-author on the women's study, said the research team was "surprised at the degree of difference we saw. I wasn't anticipating it would be that much."

That's because there are so many other factors that could affect bone density, the researchers said. For example, older men taking SSRIs have lower physical activity or greater intake of alcohol. And older women tend to be more depressed than men, and they lose bone density at a greater rate earlier in life due to menopause.

"One of the concerns we had was depression has its own effects on bones, so depressed people probably have lower bone density independent of their SSRI use," Bliziotes said. "Still we found that the bone density was lower in SSRI users even after controlling for as many confounding variables as we could."

Haney and Bliziotes both agree the results don't mean people taking antidepressants, even SSRIs, should stop.

"Depression is a serious condition and it's important not to stop antidepressants abruptly or without talking to your physician," Haney said. "However, it may be worth paying special attention to the things we know can prevent osteoporosis, such as exercise, taking adequate calcium and vitamin D, and it might be worth consideration of screening for low bone density."

Bliziotes added, "We don't want to leave anyone with the impression that if they're on an SSRI for a valid reason, they should go off it. They have benefits, they've been demonstrated, and people have been put on them for valid reasons, so we don't want to do anything that would jeopardize that."

Haney said future studies will continue to track bone density changes over time to help researchers determine the effects of SSRI use on markers of bone cell turnover.

 The studies appear in the Archives of Internal Medicine, a publication of the Journal of the American Medical Association. The studies were funded by the National Institutes of Health.

Note: This story has been adapted from a news release issued by Oregon Health & Science University.



 

...

Columbine Kid - Orange County, California

Columbine survivor forgives
Hit 8 times in 1999 shooting rampage, Mark Taylor, 24, now lives in homeless shelter in Buena Park.
 
BUENA PARK – Mark Taylor still bears scars – on his body and in his mind – of April 20, 1999.

Taylor was eating lunch in an outside area near the Columbine High School cafeteria when the Jefferson County, Colo., campus became a war zone.

Taylor, now 24, was shot eight times by students Eric Harris and Dylan Klebold, who went on a shooting rampage that lasted 16 minutes.

Those wounds forever changed the lives of Taylor and his mother, Donna. Today, Taylor and his mother live in Southern Baptist Church's homeless shelter in Buena Park. All the family's energy – and scarce resources – have been spent speaking out about the Columbine tragedy.

"It was right when we said a prayer when the whole thing happened," says Taylor, his hands trembling. "When you get shot, you remember everything."

Last month, he released a book, "I Asked, God Answered: A Columbine Miracle." The 55-page book sells for $7.99 on Amazon.com.

Taylor realizes the book isn't going to make a lot of money, but says it was something he had to do: "(This is) for the victims and their healing process. It's about forgiveness. That's what helped me get through it.

Tragedy, aftermath

Harris and Klebold, clad in black trench coats, killed 13 people, beginning at 11:19 a.m. Another 21 people were injured. Shortly after noon, they took their own lives.

For the assault, they were equipped with 20-pound propane bombs and pipe bombs, which failed to explode. They had ammunition strapped to their bodies, according to the Jefferson County Sheriff's Department.

Taylor, who was hit in chest and legs, spent two months in a hospital with tubes attached to his body. He returned home, where he was under the care of a nurse. He never got a diploma from Columbine.

He remembers the medical staff at the hospital discussing his condition: They called him the dead kid talking.

In time, most of the physical problems healed, Taylor says – aside from chronic back pain that hinders his ability to work.

The emotional pain also lingers. Both Taylors have vowed not to use medication to help cope with the trauma, blaming the gunmen's use of drugs for the rampage. Instead, they relied on prayer.

Taylor's father left the family four years ago, saying he could not deal with the constant reminders of the incident, according to Donna Taylor, 58.

To make ends meet, Mark Taylor accepted occasional speaking engagements around the country. Sometimes he was paid; sometimes he wasn't.

"It's been a tough spot for me," Donna Taylor says. "It's a total nightmare. … I never thought we'd have to go through this."

Faith prevails

During a speaking engagement, the Taylors met Dr. Wiley Drake, pastor at Buena Park's Southern Baptist Church. Drake and Donna Taylor stayed in touch.

"I was kind of a pastor from afar," says Drake, who welcomed the family into the shelter two weeks ago. He offered to let them stay until they bounced back.

Mark Taylor says his life had been turned upside-down by the rampage. He doesn't know what the future holds, but he does know that he wants to help his fellow classmates and others affected by the Columbine massacre.

"I think forgiveness is a big step toward moving on," says Taylor, who is considering a life in the ministry. "Just helping some else heal is all I need."

 

 

...

Monday, June 25, 2007

Mental Screening Bashed

 
Fort Wayne News Sentinel (Indiana)
June 25, 2007
Mental  health screening

The article, "Help to ensure happy, healthy kids," by Jennifer L. Boen, barely scratches the surface over the controversy of mental health screening. Before the author goes touting supposed benefits, the pitfalls need to be examined. Why? Because it's a child's life that hangs in the balance.

To date there has been no study or documentation that proves that screening "benefits children," and there is no scientific study that shows that "early intervention can also spare a life." But there is plenty of evidence showing otherwise.

Experts say there is no evidence to support that TeenScreen does anything other than guarantee that a large number of children will end up on drugs. In May, 2004, after an in-depth investigation, the United States Preventive Services Task Force issued a report with findings that said:

1. There is no evidence that screening for suicide risk reduces suicide attempts or mortality; 2. There is limited evidence on the accuracy of screening tools to identify suicide risk; 3. There is insufficient evidence that treatment of those at high risk reduces suicide attempts or mortality.

A 2006 study that investigated TeenScreen, said that mental health screening should be considered only investigational in nature, and the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) labels screening as "experimental."

According to another 2006 peer-reviewed study: "Simply Asking Questions Can Increase Risky Behaviors" - the title says it all.

Then of course, there is the matter of TeenScreen's 10-minute questionnaire, a survey that asks questions such as:

1. Have you often felt very nervous or uncomfortable when you have been with a group of children or young people - say, like in the lunchroom at school or at a party?
2. Have you often felt very nervous when you've had to do things in front of people?
3. Have you often worried a lot before you were going to play a sport or game or do some other activity?
4. Has there been a time when you had less energy then you usually do?
5. Has there been a time when you felt you couldn't do anything well or that you weren't as good-looking or as smart as other people?
6. Has there been a time when nothing was fun for you and you just weren't interested in anything?

Hmm, sounds like normal behavior and thoughts are being labeled as pathological.

The screening "tools" have an 84 percent false-positive rate, meaning that 84 percent of the children screened were falsely identified. The developer of TeenScreen says that the false-positive rate can overwhelm a school with the number of students identified and acknowledges that his screening tool "would deliver many who were not at risk for suicide, and that could reduce the acceptability of a school-based prevention program."

TeenScreen is set up to "arrange treatment" - their words. TeenScreen claims throughout their literature that "The TeenScreen Program makes no treatment recommendations," yet "treatment" is the long-term goal for TeenScreen, according to their director. The TeenScreen developer says, "The main role is to motivate the student and their parents to seek treatment and to connect the adolescent to a mental health service in their community."

There are ways to help our children but screening them for mental health is not one of them.

Susan Weibert
Buffalo, N.Y.  
 
 

 

...

Sunday, June 24, 2007

Judge sets date for first Zyprexa trial

 
Indianapolis Star
June 23, 2007
 
Judge sets date for first Zyprexa trial
Injury suits linked to side effects tentatively scheduled for Oct. 15
Indianapolis-based Eli Lilly and Co. could face its first trial this fall in personal injury lawsuits over the its top-selling schizophrenia drug Zyprexa, a federal judge in New York said Friday.
 
U.S. District Judge Jack Weinstein in Brooklyn said he will try about 30 Zyprexa lawsuits at one time and set a tentative trial date of Oct. 15.
 
Lilly has spent more than $1 billion to settle 26,000 product-liability claims against Zyprexa. Another 900 claims were settled this month, but Lilly hasn't disclosed the amount of those settlements.
 
At least eight lawsuits have been filed by several states that claim Lilly failed to disclose that Zyprexa causes high blood-sugar levels, weight gain, diabetes complications and other health problems.
 
At a hearing Friday, Weinstein told lawyers that cases filed in the Eastern District of New York "will be tried, dismissed or settled." He said he wants to "close them out by the fall."
Nina Gussack, a lawyer for Lilly with Pepper Hamilton, said after the hearing, "It's plain that the judge wants to move the cases forward on a variety of grounds. Lilly is going to be prepared to do whatever is necessary to address his variety of requests."
 
Weinstein is presiding over lawsuits originally filed in state and federal courts around the country by patients who sued Lilly over Zyprexa. The drug was approved in 1996 by the Food and Drug Administration to treat schizophrenia and bipolar disorder.
 
Weinstein said he will send cases that weren't filed in New York back to the courts where they originated. The judge said about 500 cases by Zyprexa users are pending before him.
 
Some of the suits claim the company marketed Zyprexa for off-label uses, including treatment of Alzheimer's disease, Tourette's syndrome and autism, without warning about its risks.
 
Zyprexa is Lilly's top-selling drug, with sales last year of $4.36 billion.

 

...

Saturday, June 23, 2007

Psychiatrist indicted for fraud in Paxil trials

http://www.dailycomet.com/apps/pbcs.dll/article?AID=/20070614/APN/706141
966

Psychiatrist indicted for fraud in Paxil trials

The Associated Press


NEW ORLEANS Dr. Maria Carmen Palazzo was indicted by a federal grand
jury on 55 counts of health care fraud and false documentation in
connection with a clinical trial of Paxil in children and adolescents,
U.S.
Attorney Jim Letten said on Thursday.

The indictment alleges that during approximately a five-year period,
Palazzo, 55, of New Orleans, defrauded Medicare in connection with
services she claimed to have rendered to patients in a Psychiatric
Partial Hospitalization Program at Touro Infirmary.

The indictment also charges that Palazzo defrauded Medicare by
submitting fraudulent invoices to Touro for consulting and medical
director services. The indictment says because of that Medicare paid
Palazzo over $653,000 she was not entitled to receive.

Palazzo, who specializes in psychiatry, is also charged with offenses
relating to clinical trials involving Paxil.

According to the indictment, Palazzo, as a clinical investigator for
SmithKline Beecham doing business as GlaxoSmithKline, fraudulently
failed to maintain and prepare records required by the FDA for
evaluation the drug's safety and effectiveness in children and
adolescents.

If convicted, Palazzo faces a maximum term of 445 years, and a fine of
$10.15 million, Letten's office said.

....

schizophrenics not taking antipsychotics more likely to recover

People with schizophrenia not taking antipsychotics more likely to
recover, states research

June 13, 2007
by Angela Hussain

http://psychminded.co.uk/news/news2007/June07/people002.htm

People diagnosed with schizophrenia who are not on antipsychotics are
more likely to experience recovery than those taking the medication,
according to an American study.

Over 15 years, schizophrenia patients not on antipsychotics showed more
periods of recovery than those taking antipsychotics, states a research
paper in last month's Journal of Nervous and Mental Disease.

Researchers reported that, after 10 years, 79% of patients on
antipsychotics were psychotic, whereas 23% of those not on medication
were psychotic. After 15 years, 65 per cent of patients on
antipsychotics were psychotic, whereas only 28% of those not on
medication were psychotic.

The study's authors - Martin Harrow and Thomas Jobe of the department of
psychiatry at the University of Illinois in Chicago - concluded that
"not all schizophrenia patients need to use antipsychotic medications
continuously throughout their lives."

They stated that certain patient characteristics - such as a "favorable
personality" - helped those not on medication to experience recovery.

The study was on 145 patients - 64 diagnosed with schizophrenia, and a
control of 81 patients who had another psychotic diagnosis, such as
paranoid disorder.

The research was part-funded by America's National Institute of Mental
Health.

....

How the FDA is becoming a Drug Company....

How the FDA is Becoming a Drug Company:
Consumer Safety and Access to Natural Health Options Threatened
Thursday, June 14, 2007

by: Byron J. Richards, CCN

Under the false pretense of improved food and drug safety the FDA is
re-inventing itself as a kingpin drug company. This charade has so far
hoodwinked virtually all members of Congress. The Senate has already
approved this FDA transformation. The House will bring similar
legislation out of committee next week, with a vote in the full House
likely in July. The measure will then go to a conference committee to
work out the differences. The final chapter in this transformation
occurs when the Reagan-Udall Foundation for the FDA becomes law, which
is scheduled to happen some time before September 30, 2007.

Even well-intended FDA employees are actively seeking new employment in
more meaningful work. Such is the case with Rosemary Johann-Liang,
former FDA deputy director of the Division of Drug Risk Evaluation.
Last year she was reprimanded for trying to put a black box warning on
Avandia, a move the FDA itself made last week in a damage-control effort
to cover its complicity with GlaxoSmithKline. After 6 1/2 years
Johann-Liang is leaving the FDA. As USA Today reports:

More here: http://www.newstarget.com/021900.html

....

Canada - Medication leaves patient crippled

Drug Side-Effects Infuriate Woman
Medication leaves patient crippled
Mon Jun 18 2007
By Jen Skerritt
 
A Winnipeg woman is furious the muscles in her hands, feet and face have been permanently crippled by a prescription drug that was supposed to relieve her anxiety and depression.

Laura Flett, 52, began taking Risperdal and Seroquel several years ago to help treat her obsessive compulsive behaviour and panic attacks. Although the drugs helped quell her uneasiness, Flett began to slowly lose control of her muscles.

She started smacking her lips together, thrusting her tongue, grinding her teeth, and having muscle spasms in her hands, feet and forehead. Flett said the spasms were uncontrollable and unpredictable, and continued to get worse.

In 2005, she was diagnosed with tardive dyskinesia -- a form of dystonia and movement condition her doctor said was related to either Risperdal, Seroquel, or both.

Now, she wants other people taking the medications to be wary of the irreversible side-effects.

"I can't peel an apple for my grandchildren," she said, tears welling up. "I wake up in the morning and both my fingers are (bent) down."

 
Dystonia is a movement disorder that affects the nervous system and is the third most common movement disorder in North America. Experts say dystonia can be genetic or caused by physical trauma and exposure to certain medications.

The disorder can affect multiple areas of the body, including the neck, eyes and limbs, and causes muscle spasms that can twist parts of the body into awkward, painful positions.

Flett can no longer use her right hand, since her fingers are constantly twisted and stiffened in a bent position. She has constant pain in her arm muscles.

Chris Summerville, executive director of the Manitoba Schizophrenia Society, said he's seen many people in the mental-health system suffer serious side-effects from their medications -- including some, like tardive dyskinesia, that never go away.

Summerville said older medications were notorious for causing muscle spasms, but drug companies sell newer drugs like Risperdal, promising that these types of side-effects are rare.

However, as time goes on and patients have been taking these new drugs for several years, Summerville said more adverse side-effects are being reported.

He said the best thing is for doctors to properly inform their patients of the risks, so they can catch movement problems early and switch medications. He said tremendous side-effects often deter some patients from taking their medication.

Flett said her doctors expect her muscle contractions will get worse and are worried they could spread to her diaphragm or chest. She said her physician brought up the idea of switching to another medication, but is too afraid, since the new side-effects include involuntary seizures -- something she's concerned could aggravate her current condition.   

 

...

Approval of Risperdal Delayed for Teens

 
Bloomberg News 
Approval of J&J's Antipsychotic Delayed for Teens (Update3)
By Lisa Rapaport

June 21 (Bloomberg) -- U.S. regulators delayed a request by Johnson & Johnson to expand use of its top-selling Risperdal to include schizophrenia and bipolar disorder in adolescents.

The Food and Drug Administration didn't request new studies on the treatment in a letter to the company, New Brunswick, New Jersey-based J&J said in a statement today. J&J said it would work with the agency to complete prescribing information on the drug, which is already approved for use in children with autism and adults with schizophrenia and bipolar disorder.

Use of antipsychotic drugs for younger patients has risen sharply in recent years, prompting concern among some doctors and parents about side effects including weight gain and diabetes. Risperdal, which generated $4.2 billion last year, is the second such drug delayed by U.S. regulators for teen use. Eli Lilly & Co.'s Zyprexa was held up in April.

``The FDA is giving approvable letters for everything under the sun these days, and in this case they are particularly gun shy because this is about kids and there are known side effects,'' said Ira Loss, an analyst at the Washington research firm Washington Analytics, in a telephone interview today.

The FDA normally issues what is known as an approvable letter to inform companies that more information is needed before a drug can be marketed in the U.S.

The shares of Johnson & Johnson fell 4 cents to $62 at 1:02 p.m. in New York Stock Exchange composite trading. The stock had declined 6 percent this year before today.

Rising Sales

About 1 in 100 people have schizophrenia, which causes hallucinations and distorted thinking, and a third of them develop it in adolescence.

Prescriptions of the drugs for teenagers are currently written mostly by psychiatrists as ``off-label'' or unapproved uses. Once a drug is cleared in the U.S., doctors aren't required to limit uses to those on the prescribing label.

Sales for Risperdal, which faces generic competition next year, rose 18 percent in 2006. Overall, prescriptions of antipsychotics for patients age 20 or younger rose sixfold from 1993 to 2002, from 201,000 to 1.22 million, according to a study published last year in the Archives of the Journal of the American Medical Association.

``There's no gold standard for treating schizophrenia in teens, and the first company to get FDA approval for this will have an edge in the very crowded market,'' said Les Funtleyder, an analyst at Miller Tabak & Co. in New York, in an interview prior to the J&J announcement.

Encouraging Use

FDA approval of antipsychotics for teenagers would encourage pediatricians and primary-care physicians to prescribe the drugs as well, said Mark Olfson, lead author of the study and a professor at Columbia University in New York. Use of Prozac and other antidepressants for younger patients soared after the FDA cleared those drugs for children.

``These antipsychotics will follow the same path as Prozac,'' Olfson said. ``The FDA label gives physicians outside psychiatry some reassurance and confidence in prescribing these medications.''

Bristol-Myers asked the FDA to approve its antipsychotic drug Abilify for schizophrenia in teenagers on June 5. Abilify sales surged 41 percent to $1.3 billion last year, helped by studies showing the pill caused less weight gain than competitors.

``There is a very likely possibility that the FDA approval of a teenage indication will provide a false sense of security,'' psychiatrist Stefan Kruszewski, of Harrisburg, Pennsylvania, wrote the FDA in a letter opposing clearance of the drugs. ``Approval would function as the means by which aggressive pharmaceutical marketing could easily persuade more practitioners to prescribe more potent medications.''

 

...

Bipolar Madness

San Francisco Chronicle

Bipolar madness?

Monday, June 18, 2007

Why did a two-day conference on the rather arcane subject of children's bipolar disorder that took place in Pittsburgh earlier this month attract intense media attention? The answer can only be the death last December of Rebecca Riley.

Rebecca was a 4-year-old girl who died, according to the medical examiner, from an overdose of clonidine, also known as Catapress. This drug is most widely prescribed to lower blood pressure but is also routinely employed by child psychiatrists to aid in sleep and to control unruly behavior in children. America is the only country that addresses the public health crisis of children's bad behavior with medications. No other society uses psychiatric drugs as widely as we do.

In this case, clonidine was one of only three psychiatric drugs given to Rebecca for the treatment of her purported psychiatric illness -- bipolar disorder. Her parents are being held for murder, charged with intentionally overdosing their daughter. Their defense: They were only following the doctor's orders.

Kayoko Kifuji, the child's psychiatrist, working at the Tufts-New England Medical Center, has withdrawn from her practice and is not answering any questions. Her license has been temporarily suspended. But she was not some extreme outlier practicing some voodoo alchemy on this child. Indeed, Tufts-New England issued a statement after the arrest of Rebecca's parents that her care "was appropriate and within responsible professional standards."

The Riley case is confusing, and responsibility for her death will ultimately decided by the courts. But her particular diagnosis and treatment have uncovered what one child psychiatrist called "the hidden tsunami" of children's mental health: the vast increase in the number of children receiving the bipolar diagnosis and the concomitant growth in the use of "mood stabilizing" drugs.

Rebecca was diagnosed at age 2 1/2 as having bipolar disorder, the new name for manic-depression. This diagnostic label conferred on Rebecca the same implications of being a chronic mental patient requiring drug treatment for the rest of her life. The conference in Pittsburgh fiercely debated the question: Can or should children that young be diagnosed with a disorder that ostensibly lasts a lifetime?

In addition to clonidine, Rebecca was also prescribed Seroquel, an anti-psychotic, and Depakote, an anti-convulsant. Neither drug is approved by the FDA for bipolar disorder in children. There are scant studies to justify such use. Is it appropriate to be prescribing these medications to someone so young?

There always have been unruly and difficult children. Rebecca's mother described her as, on the surface, very irritable, but the household was highly dysfunctional (Rebecca's older brother and sister were also on bipolar medications).

Nearly 3.5 million children in the United States take drugs for conditions such as attention deficit hyperactivity disorder. About 1.5 million children received an anti-psychotic prescription in 2006. While these drugs can be helpful in the short-term to improve children's behavior, they are not the moral equivalent to addressing aspects of their home life that are contributing to their problems. All these drugs have potential short and long-term side effects. Yet medication is often the desperate "quick fix" answer to chronic and difficult social problems.

Even if we agree on the need to medicate these children, should we be labeling children as young as age 2 as bipolar? Debate rages within professional circles. The most recent guidelines issued three months ago by the American Academy of Child and Adolescent Psychiatry specifically caution against the use of this diagnosis and its treatment in children younger than 6. Still, it may not be coincidental that the Tufts Medical Center is only a short drive from Harvard University, where that institution's pre-eminent child psychopharmacology clinic has been at the forefront of broadening and promoting the bipolar diagnosis for more and younger children.

Many doctors question the tie between any child's behavior and the adult bipolar condition. Given the predictable turbulence of adolescence (not to mention the terrible 2s), shouldn't one wait until children reach their early 20s before assigning this lifelong sentence? Other doctors say we cannot afford to wait to aggressively treat these problems of childhood, even though clear prospective links between the behaviors of bipolar illness of children to the later adult disorder have not been established.

Of course, the pharmaceutical industry's influence also cannot be denied. It vigorously promotes with millions of dollars the research and professional "education" that supports the pediatric bipolar diagnosis.

While the conference in Pittsburgh raised troubling questions about the bipolar "epidemic" in children, it will not change in the short term the way America copes with very difficult children. In the meantime, the practical aspects of addressing children's extreme behavior in an otherwise underfunded mental health system will tilt doctors toward making such a diagnosis and using these sedating and potentially dangerous drugs.

Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek and is the author of "The Last Normal Child" (Praeger, 2006).

 

...

Wednesday, June 20, 2007

Canada - Stop Doping Our Kids

Stop doping our kids

National Post

Wednesday, June 20, 2007

I have been sounding the alarm for more than three years about how atypical antipsychotic drugs, designed for floridly psychotic adult patients, are now being prescribed to thousands of children. These drugs are chemical straitjackets and are being used to control children's behaviour under the guise of "treatment." These prescriptions are being used as methods of social control and are a serious violation of childrens' human rights.

It is interesting that in some editions of the Post, this front page article continued on an inside page alongside an article about outlawing spanking. Society clearly does not sanction assaulting children, and the public needs to know that these drugs are a form of assault.

The government must initiate an investigation into the use of atypical antipsychotic drugs on children and classify it as a form of criminal assault.

Marty Mckay, Clinical Psychologist, Toronto
 

 

...

Tuesday, June 19, 2007

Psychiatric medication leaves patient crippled

Drug Side-Effects Infuriate Woman
Medication leaves patient crippled
Mon Jun 18 2007
By Jen Skerritt
 
A Winnipeg woman is furious the muscles in her hands, feet and face have been permanently crippled by a prescription drug that was supposed to relieve her anxiety and depression.

Laura Flett, 52, began taking Risperdal and Seroquel several years ago to help treat her obsessive compulsive behaviour and panic attacks. Although the drugs helped quell her uneasiness, Flett began to slowly lose control of her muscles.

She started smacking her lips together, thrusting her tongue, grinding her teeth, and having muscle spasms in her hands, feet and forehead. Flett said the spasms were uncontrollable and unpredictable, and continued to get worse.

In 2005, she was diagnosed with tardive dyskinesia -- a form of dystonia and movement condition her doctor said was related to either Risperdal, Seroquel, or both.

Now, she wants other people taking the medications to be wary of the irreversible side-effects.

"I can't peel an apple for my grandchildren," she said, tears welling up. "I wake up in the morning and both my fingers are (bent) down."

 
Dystonia is a movement disorder that affects the nervous system and is the third most common movement disorder in North America. Experts say dystonia can be genetic or caused by physical trauma and exposure to certain medications.

The disorder can affect multiple areas of the body, including the neck, eyes and limbs, and causes muscle spasms that can twist parts of the body into awkward, painful positions.

Flett can no longer use her right hand, since her fingers are constantly twisted and stiffened in a bent position. She has constant pain in her arm muscles.

Chris Summerville, executive director of the Manitoba Schizophrenia Society, said he's seen many people in the mental-health system suffer serious side-effects from their medications -- including some, like tardive dyskinesia, that never go away.

Summerville said older medications were notorious for causing muscle spasms, but drug companies sell newer drugs like Risperdal, promising that these types of side-effects are rare.

However, as time goes on and patients have been taking these new drugs for several years, Summerville said more adverse side-effects are being reported.

He said the best thing is for doctors to properly inform their patients of the risks, so they can catch movement problems early and switch medications. He said tremendous side-effects often deter some patients from taking their medication.

Flett said her doctors expect her muscle contractions will get worse and are worried they could spread to her diaphragm or chest. She said her physician brought up the idea of switching to another medication, but is too afraid, since the new side-effects include involuntary seizures -- something she's concerned could aggravate her current condition.

 

...

Attacks Continue on Psychiatry

 
Boston Globe
Misguided standards of care

AS A doctor, I did the nearly unthinkable at a recent conference on bipoloar disorder in children. I charged another doctor with moral responsibility in the death last December of Rebecca Riley, a 4 -year-old girl from Hull. Naming names in medicine is just not done very often -- and I knew the personal and professional risks I was taking. Yet I felt compelled to name Joseph Biederman, head of the Massachusetts General Hospital's Pediatric Psychopharmacology clinic, as morally culpable in providing the "science" that allowed Rebecca to die.

Rebecca's parents have been jailed and charged in her death. They are accused of intentionally overdosing her with clonidine, an anti hypertensive and sedative drug -- one of three psychiatric medications prescribed by a Tufts-New England Medical Center child psychiatrist. Rebecca had been treated with these medications since the age of 2 1/2 for the purported diagnosis of bipolar disorder -- the new name for manic-depression.

While the psychiatrist involved has withheld comment on the case, both her lawyer and the medical center have defended her actions as "within the standards of care." Biederman and his colleagues at Harvard are the professionals most responsible for developing and promoting those standards of care -- which include diagnosing preschool children as young as 2 with bipolar disorder and treating them with multiple medications.

Biederman shocked the child psychiatric world in 1996 by announcing that nearly a quarter of the children he was treating for attention deficit hyperactivity disorder also met his criteria for bipolar disorder. Up until then bipolar disorder was rarely diagnosed in teenagers and unheard of in prepubertal children. Biederman could justify his findings by simply broadening the semantic definitions of a previously more circumscribed condition contained within American psychiatry's bible -- the "Diagnostic and Statistical Manual of Mental Disorders."

Biederman has produced a number of studies and papers purporting to demonstrate the validity of his diagnosis and treatment. His research has always epitomized the best of what the DSM model of psychiatry could expect. But the diagnoses in the manual, in concept, are closely linked to the medical model of biologically based psychiatric disorders and focus exclusively on the individual.

While the manual provides helpful clinical guidance in adults, it begins to unravel with its assumptions about discrete and specific disorders in children and ignores the families and environments in which children live. The ultimate absurdity of this scientific model is diagnosing bipolar disorder in 2 year olds and linking it to the adult disorder with the same name -- in the process saddling young children as chronic mental patients condemned to a lifetime of psychiatric drugs.

Even the American Academy of Child and Adolescent Psychiatry -- in its recent parameters on the diagnosis in children -- eschews the bipolar diagnosis and its consequent medical treatment in children under 6. Still there are thousands of potential Rebecca Rileys being treated with multiple psychiatric drugs because Biederman has said it's OK and necessary. Supported by millions of dollars of drug industry promotional funding, Biederman and his colleagues circle the globe offering professional medical "education" for their singular point of view.

Finally, it's sad but true -- the field of child psychiatry is afraid of Biederman. One can hear the worries and fears whispered in the academic halls and clinics over where Biederman has taken the profession. Yet to politely challenge Biederman in public is to risk public retribution and ridicule from him and his team. Also academic researchers in child psychiatry risk losing their funding if they criticize this darling of the pharmaceutical industry, which provides most of the money these days for psychiatric research.

The silence was deafening -- and Rebecca's death pushed me over the edge -- because for over a decade I've have been uncomfortable about these practices in young children. I am not against psychiatric drugs for children. I've written prescriptions for children for 30 years in a clinical practice not tied to the drug industry.

I risk personal censure and loss of credibility in an advocacy for a broader concept and treatment for children with behavior problems in naming this doctor. But this time, Dr. Biederman, you have gone far.

Dr. Lawrence Diller practices behavioral/developmental pediatrics in Walnut Creek, Calif., and is the author of "The Last Normal Child: Essays on the Intersection of Kids, Culture and Psychiatric Drugs."

 

 

...

Canada - More children taking anti-psychotic drugs

Sharon Kirkey, CanWest News Service

Tuesday, June 19, 2007

Anti-psychotics are being widely prescribed to children with behaviour and mood problems, with a significant proportion going to children under nine, new research shows.

Ninety-four per cent of 176 child psychiatrists in Canada surveyed are prescribing powerful drugs known as atypical anti-psychotics for a variety of disorders and symptoms, including anxiety, attention-deficit hyperactivity disorder and "poor frustration tolerance."

While most prescriptions were for children 13 and older, a "surprising" number were for the very young: 12 per cent of all prescriptions were for children aged eight or under, including three-year-olds.

NEW RESEARCH: Dr. Tamison Doey is the lead author of research into the prescribing of anti-psychotic drugs to children.

NEW RESEARCH: Dr. Tamison Doey is the lead author of research into the prescribing of anti-psychotic drugs to children.
None of the drugs has been officially approved for use in children. Risperidone (brand name Respirdal) was the most commonly prescribed atypical anti-psychotic to children, followed by olanzapine (Zyprexa) and quetiapine (Seroquel).

All are in a different class from Ritalin, a stimulant used to treat attention deficit disorder in children.

Originally developed to treat schizophrenia and mania, so-called ATAs are now increasingly being used to treat non-psychotic disorders in adults, children and teens.

"These medications are currently being used off-label without clear guidelines for indications, dosing and monitoring," researchers report in the most recent issue of the Canadian Journal of Psychiatry.

"There is an urgent need for more data regarding safety and monitoring of these medications in children."

In the U.S., the number of visits to a doctor that ended with a patient under 20 being prescribed an anti-psychotic soared six fold between 1993 and 2002.

The new Canadian survey can't answer just how many children or teens in Canada are on anti-psychotics. But it shows prescribing by child psychiatrists and pediatricians who specialize in developmental problems is "ubiquitous."

"The trouble with a study like this is, it doesn't tell us whether that's a good thing or a bad thing. We just know it's happening," says lead author Dr. Tamison Doey, head of the division of child and adolescent psychiatry for Windsor and an adjunct professor at the University of Western Ontario.

"Intuitively we all say, 'Geez, these are young kids to be on medicine. But kids that age are put on drugs for asthma, and they're given antibiotics and different sorts of medication. I think we all get a bit concerned if it's something that affects the brain."

As doctors become more confident with ATAs, the drugs are filling an important niche, Doey says.

"We have data to show they are helpful. The concern is we also have data showing that when you stop the medication, many times the problems come back. That means you're maybe looking at having to take these drugs for the long term. Then you start to worry, 'these are kids, what will happen down the road?'"

Most of the specialists surveyed monitored their patients. But the types and frequency of tests performed vary widely.

"The concern is, will other doctors start to use these medicines and how can we guide them to do it appropriately," Doey says.

Atypical anti-psychotics are considered a significant improvement over older anti-psychotics that were used in both adults and children. For one thing, they don't cause the same neurological side effects, such as uncontrolled jerking and twisting.

But they can cause substantial weight gain. Johns Hopkins researchers have warned the drugs might trigger insulin resistance in children, increasing the risk of developing Type 2 diabetes and heart disease when they're older.

The drugs work by blocking dopamine, a brain chemical involved in aggression and impulsivity.

Doey says they can make the difference between a having a child in school or not, "or a child having friends or having terrible outbursts every time something doesn't go their way."

They are being used to treat depression, impulsivity and children who frustrate easily.

"That doesn't mean they just get a bit upset. The kids we see will have major aggressive or disruptive episodes for even the slightest reasons," Doey says.

"So if they can't do something in school or someone tells them to turn off the television or you can't run in the corridor, you name it, they proceed to become very angry and aggressive and out of control."

Her team plans to follow children prescribed atypical anti-psychotics over a year to look at the effects of the drugs over the longer term.

 

...

Sunday, June 17, 2007

Down Under Documents Zyprexa Cases

The Australian (Australia)
June 18, 2007 Monday
Aussies in class action on drug
BYLINE: Cath Hart
LOCAL; Pg. 7

PHARMACEUTICAL giant Eli Lilly faces a class action from a group of Australians claiming they have suffered dangerous or life-threatening side-effects including weight gain, pancreatitis and diabetes after taking the anti-psychotic drug Zyprexa.

The class action, the first over the allegedly negative affects of Zyprexa outside the US, started on behalf of a 32-year-old Tweed Heads saxophonist who developed pancreatitis after taking the drug.

Brisbane law firm Nicol Robinson Halletts expanded the case into a class action after others claimed their health had been harmed by Zyprexa.

Lawyer Simon Harrison said his team hoped to link the Australian claims to a $1.2billion group of settlements by Eli Lilly in the US over 30,000 similar cases.

''We are presenting a class action in respect of alleged side-effects from the use of Zyprexa, some of which are life-threatening,'' Mr Harrison said.

''We'll be alleging Eli Lilly minimised or understated the risk, and we're dealing with associate attorneys in the US with a view to including the class action within the American settlements.

''The concern that we as plaintiff lawyers have is that information concerning the risks wasn't presented as soon as it should have been.''

Zyprexa, or olanzapine, is used to treat people with schizophrenia or bipolar disorder and has been available in Australia since mid-1997.

Mr Harrison said there were litigants from Victoria, South Australia, Western Australia and Queensland, ''from middle-aged to early 20s'', who had metabolic disorders such as diabetes and pancreatitis.

A spokeswoman for Eli Lilly said the company was aware of the initial case but did not have details of the class action.

''Zyprexa remains an effective medication for the treatment of schizophrenia and bipolar disorder and its benefit-risk profile is not altered by this case,'' she said.

''An adverse event does not necessarily have a causal relationship to the medicine.''

Since April 1997, the Therapeutic Goods Administration has had reports of 40 deaths and 1231 adverse reactions among people taking Zyprexa.

Australian Medical Association federal counsellor Martin Nothling, a psychiatrist, said many of the problems associated with anti-psychotic medications could be avoided if the patient was ''intensely followed up'' by a treating psychiatrist.

''The benefits outweigh the risks,'' Dr Nothling said.

The figures, obtained by the Citizens Committee for Human Rights, co-founded by the Church of Scientology, show 53 cases of abnormal liver function in people taking Zyprexa, 87 cases of weight increase and more than 40 cases of metabolic disorders including diabetes and hyperglycemia.

The TGA did not respond to requests for comment.

 

...

Scrutiny of Psychiatry Continues

 
 The Boston Globe
 
Boston Globe
Backlash on bipolar diagnoses in children
MGH psychiatrist's work stirs debate

No one has done more to convince Americans that even small children can suffer the dangerous mood swings of bipolar disorder than Dr. Joseph Biederman of Massachusetts General Hospital.

From his perch as one of the world's most influential child psychiatrists, Biederman has spread far and wide his conviction that the emotional roller coaster of bipolar disorder can start "from the moment the child opened his eyes" at birth. Psychiatrists used to regard bipolar disorder as a disease that begins in young adulthood, but now some diagnose it in children scarcely out of diapers, treating them with powerful antipsychotic medications based on Biederman's work.

"We need to treat these children. They are in a desperate state," Biederman said in an interview, producing a video clip of a tearful mother describing the way her preschool daughter assaulted her before the child began treatment for bipolar disorder. The chief of pediatric psychopharmacology at Mass. General, he compares his work to scientific break throughs of the past such as the first vaccinations against disease.

But the death in December of a 4-year-old Hull girl from an overdose of drugs prescribed to treat bipolar disorder and attention deficit hyperactivity disorder has triggered a growing backlash against Biederman and his followers. Rebecca Riley's parents have been charged with deliberately giving the child overdoses of Clonidine, a medication sometimes used to calm aggressive children. Still, many wondered why a girl so young was being treated in the first place with Clonidine and two other psychiatric drugs, including one not approved for children's use. Riley's psychiatrist has said she was influenced by the work of Biederman and his protege, Dr. Janet Wozniak.

"They are by far the leading lights in terms of providing leadership in the treatment of children who have disorders such as bipolar," said J. W. Carney Jr., lawyer for Dr. Kayoko Kifuji, a Tufts-New England Medical Center psychiatrist who temporarily gave up her medical license after Riley died on Dec. 13, 2006. "Dr. Kifuji subscribes to the views of the Mass. General team."

Part of the criticism of Biederman speaks to a deeper issue in psychiatry: the extensive financial ties between the drug industry and researchers. Biederman has received research funding from 15 drug companies and serves as a paid speaker or adviser to seven of them, including Eli Lilly & Co. and Janssen Pharmaceuticals, which make the multi billion-dollar antipsychotic drugs Zyprexa and Risperdal, respectively. Though not much money was earmarked for bipolar research, critics say the resources help him advance his aggressive drug treatment philosophy.

Numerous psychiatrists say Riley's overdose suggests that bipolar disorder is becoming a psychiatric fad, leaving thousands of children on risky medications based on symptoms such as chronic irritability and aggressiveness that could have other causes. Riley's father, for example, had only recently returned to the home after being accused of child abuse, according to police. Since the girl's death, state officials have stepped up a review of the 8,343 children taking the latest antipsychotic medications under the Medicaid program for conditions including bipolar disorder, to be sure the treatment is appropriate.

Psychiatrists too often prescribe these medications, which carry side effects such as weight gain and heart disease risk, without addressing problems in the children's lives, said Dr. Gordon Harper, director of child and adolescent services at the state Department of Mental Health. He likened the approach to "tuning the piano while the subway is going by."

Aggressive treatment
Biederman's critics chide him for not speaking out against misuses of a diagnosis that he has helped inspire. Among leading authorities on bipolar disorder, the Mass. General team has proposed the most aggressive treatment for the broadest group of children, they say, and Biederman should take responsibility when treatment goes wrong. At a conference on bipolar disorder at Pittsburgh's Point Park University last weekend, one speaker, Dr. Lawrence Diller, a California behavioral pediatrician, contended that Biederman bears some blame for Riley's death.

"I find Biederman and his group to be morally responsible in part," said Diller, whose popular book, "Running on Ritalin," accused psychiatrists of over treating another childhood condition, attention deficit hyperactivity disorder. "He didn't write the prescription, but he provided all the, quote, scientific justification to address a public health issue by drugging little kids."

Biederman rejects the idea that Riley's death is a cautionary tale, accusing critics of exploiting a tragedy to fan fears about psychiatry, a profession that has long faced prejudice. "The fact that she had XY drug or XY treatment is irrelevant to what happened. . . . If this child had the same outcome from treatment for asthma or seizures, we wouldn't have this frenzy," said Biederman in an interview at Mass. General's Cambridge mental health clinic.

Though Biederman acknowledges that distinguishing bipolar disorder from ordinary crankiness and flights of fancy in young children is challenging, he insists there is no ambiguity in the patients at his practice. "People have to wait a long time to see me or my colleagues. . . . It's not that somebody comes to me after their child has a temper tantrum. They do things for years that are dangerous. These are things that profoundly affect the child," said Biederman, putting them at risk of academic failure or even suicide.

Biederman dismisses most critics, saying that they cannot match his scientific credentials as co author of 30 scientific papers a year and director of a major research program at the psychiatry department that is top-ranked in the "US News & World Report" ratings.

The critics "are not on the same level. We are not debating as to whether [a critic] likes brownies and I like hot dogs. In medicine and science, not all opinions are created equal," said Biederman, a native of Czechoslovakia who came to Mass. General in 1979 after medical training in Argentina and Israel. He now lives in Brookline

Struggle for research funds  
 
Biederman's thinking on bipolar disorder grew out of his work in the early 1990s, when he observed that many children referred to Mass. General's psychiatric clinic seemed to have periods where they were extremely aggressive, deeply depressed, or angry. And they were not getting better from taking medications such as Ritalin, which is prescribed for attention deficit hyperactivity disorder.
 
 
At the time, psychiatrists considered bipolar disorder a condition that typically revealed itself around age 20, and rarely in children under 12, but Biederman believed that many of his patients met the definition normally applied to adults. Working with Wozniak, he published an influential paper in 1995 reporting that one out of six children at his clinic might be bipolar and that the rate was even higher among children with ADHD.

Biederman was already quite successful as an ADHD researcher, establishing close ties with companies that manufactured drugs such as Ritalin to fund research projects that the federal government would not pay for. He also received payments for giving speeches about mental health issues and serving on scientific advisory boards that typically meet a few times annually to discuss research. He declined to say how much he receives, but said that all of the income was approved by both Harvard Medical School and the hospital.

Biederman's boss said he does not believe the money affects Biederman's judgment.

"I think a pharma person would not dare to tell Joe what to say," wrote Dr. Jerrold Rosenbaum , chief of psychiatry at Mass. General, in an e-mail. "And if they made that mistake, it would be only once. . . . For Joe, it is his ideas and mission that drive him, not the fees."

Biederman said he quickly discovered that drug companies were less interested in bipolar disorder than the more established ADHD. He and Wozniak, who did not respond to a request for an interview, struggled to get funding for research on bipolar children. "The more controversial a diagnosis is, the harder it is to get funding from conventional sources," he explained.

Contrasting viewpoints  
Occasionally, they received small grants from drug companies or private philanthropies to test drugs on children, but Biederman admits these studies are not enough to prove the drugs are safe and effective. Nonetheless, the Mass. General studies were enormously influential: their 2001 study, in which 23 children diagnosed as bipolar received the drug Zyprexa for eight weeks, became one of the most frequently quoted articles in the history of the Journal of Child and Adolescent Psychopharmacology. The study showed that the drug eased outbreaks of aggression, though children typically gained more than 10 pounds.

Biederman was disappointed that he could not do more comprehensive studies, but he saw no reason to delay treatment. "At least the line of drugs I'm talking about gives some relief," he said. "The only way to understand the side effects is in the context of the seriousness of the illness."

As bipolar disorder received increasing media attention, Biederman and Wozniak's research was often cited as the scientific rationale for diagnosing and treating the disease aggressively  (disease?  huh?   where's the blood test for that? - ed). Another leading researcher, Dr. Barbara Geller of Washington University in St. Louis, adopted a more restrictive view, requiring that children have a series of specific symptoms such as reduced need for sleep before she would diagnose the disorder. But the Mass. General team used broader categories, saying that children who are extremely irritable or aggressive might be bipolar. Skeptics said those symptoms were too common, leaving too much room for dispute over who is really sick.

Dr. Biederman's staff "can do the same diagnostic interview on 100 children and come up with five or 20 bipolar disorders, and I might do the same thing and find only one or none," said Dr. Jon McClellan , a psychiatrist at the University of Washington who chaired a panel of the American Academy of Child and Adolescent Psychiatry that recently concluded there is no proof that children under 6 can be diagnosed with the disorder. He says he has received no money from the pharmaceutical industry for years.

A surge in diagnoses
Biederman's work helped fuel a surge in the number of children diagnosed with bipolar disorder over the past 15 years. A national study of community hospitals found that the percentage of mentally ill children diagnosed as bipolar quadrupled from 1990 to 2000.

The rapid rise raised concerns at the National Institute of Mental Health, prompting its top officials to convene leading specialists, including Biederman, to urge them to come up with diagnosis and treatment standards. The resulting guidelines, released in 2001, acknowledged that Biederman was right: Bipolar disorder can strike before puberty. However, the guidelines also stated that identifying the disease among children is challenging because normal children are prone to be irritable, aggressive, or giddy.

Dr. Steven Hyman, who was then director of the mental health institute and is now provost at Harvard University, said he remains very concerned about the growing use of "big gun" antipsychotic drugs such as Zyprexa, Risperdal, and Seroquel on children. In the Massachusetts Medicaid program, the number of people under 18 receiving at least one of the "atypical antipsychotic" drugs rose from 6,943 in 2002 to 9,123 in 2005, a 31 percent jump, before declining to 8,343 in 2006. Hyman says that none of the drugs has the approval of the Food and Drug Administration for use in bipolar children, and doctors prescribe them based on their individual judgment.

"We don't know the first thing about safety and efficacy of these drugs even by themselves in these young ages, let alone when they are mixed together," said Hyman.

Rebecca Riley's treatment
Kifuji was careful in treating Rebecca Riley, meeting the child six times before diagnosing bipolar disorder, according to Carney. Based on the child's behavior and family history, Kifuji prescribed three drugs to the 3-year-old child, including the antipsychotic medication Seroquel and Clonidine, a high blood pressure medicine that is often prescribed to calm aggressive children. Last year, Clonidine was prescribed to 1,195 children under age 7 served by the Massachusetts Medicaid program, including Riley.

Police charge that her parents, Carolyn and Michael Riley , repeatedly convinced Kifuji to give them extra Clonidine, ultimately accumulating dozens of extra pills that they used to control the little girl. Long before the child finally died on the floor beside her parents' bed, the police report said, teachers and school nurses noticed that she had become lethargic like a "floppy doll" on a nurse's lap.

Carney said his client, who is not practicing while the investigation continues, did nothing wrong in writing the prescriptions for the girl. Although some were shocked that the child was taking so much medication, Carney said Kifuji was practicing mainstream psychiatry for a very troubled child. He observed that Biederman's "research and teaching validates Dr. Kifuji's work with patients."

 

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