Thursday, May 28, 2009

Video-Risperdal Creating Lactating Breasts on Boys

CBS Evening News [click for graphic video]
– May 25, 2009 – Risperdal


Graphic CBS Video Covering Law Suit Against Johnson & Johnson for their Antipsychotic Risperdal Creating Lactating Breasts in Male Children


“Caution: Graphic Content:” For children “diagnosed” with ADD and bi-polar disorder, Risperdal is used for “treatment”. The side effects are putting them at serious risk.

2 Comments on Video

  • Lisa Jones RN

    I cried the first time I had to give my son Risperdal. I am now homeschooling and have him OFF the medication. He is doing well….now.

    It is the pubic school system that pushes this !! When will it ever stop?

  • It would never cross my mind to give a kid or anyone a substance to “solve” a behavioral problem.

    Why?

    Look around you – look at the ever-growing population of insane people and compare that to the ever-growing, billion-dollar drug sales business in the United States.

    People need to come to their senses and stop buying into this practice, this money-making racket, and justice needs to be brought once and for all to everyone involved in these CRIMINAL activities.

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Thursday, May 21, 2009

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."

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Monday, May 18, 2009

In Senate Probe, NAMI Admits To Over Half Its Budget Being Pharma Dollars

FuriousSeasons.com
May 06, 2009

Most of you are aware that Sen. Charles Grassley (R-Iowa) sent a letter to the National Alliance on Mental Illness last month, asking for the organization, which lobbies Congress, to reveal how much it gets from what pharma companies. NAMI has long been known,a s I've pointed out for three years, to be receiving about 50 percent of its annual budget (around $12 million to $13 million total) from pharma companies, which is kind of interesting for a group that styles itself as "the nation's voice on mental illness." Of course, many of the group's initiatives, nationally and locally, involve getting people to understand that mental illness comes from bad brains and that bad brains require medications made by the companies supporting NAMI. It's the bio-pharma marketing model run amok. (Much past coverage of NAMI here.)

Anyway, NAMI replied to the Senator and its reply was obtained by MindFreedom, a fairly anti-meds group, and posted to its website. In it, Michael Fitzpatrick, NAMI's executive director, states that the group has received on average 56 percent of its annual budget from pharma companies from 2005 to 2009. Fitzpatrick, who defends the group's pharma dough, claims that NAMI's strategic plan is to reduce that percentage dramatically in coming years. He told me the same thing when I met with him in 2005 (back when I was still at a newspaper). Four years later, NAMI is still pulling in many millions from pharma.

In fact, NAMI is now breaking out its pharma contributions each quarter, a practice it apparently began this year. For the first quarter of 2009, NAMI took in $1,249,340 from pharma companies and foundations. You can read the list here, including $25,000 from AstraZeneca for "Exemplary Psychiatrist Awards," presumably to be presented at NAMI's annual convention. In fact, you'll be amazed at how much of that $1.2 million is aimed at NAMI's annual convention--$147,500.

Bristol-Myers Squibb, for example, gave $262,500 in the first quarter. Some $37,500 of that is for something called "NAMI Depression Initiative." BMS doesn't make an anti-depressant and NAMI, according to Fitzpatrick's letter, hasn't been bought by Big Pharma. Oh, wait, but there's that new add-on for depression indication for BMS' Abilify antipsychotic. I bet that whatever program this is at least includes a mention of using antipsychotics to treat depression.
Posted by Philip Dawdy at May 6, 2009 12:05 AM

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Mass. Medicaid to get $22.5 million in Lilly settlement

The Boston Herald
Monday, May 18, 2009

Eli Lilly & Co. has agreed to pay nearly $22.5 million to the Massachusetts Medicaid program to resolve allegations that the company engaged in the improper marketing of its antipsychotic drug, Zyprexa, according to the Massachusetts Attorney General’s Office.

The Massachusetts payment is part of a national settlement that has returned more than $700 million to Medicaid programs nationwide and an additional $65 million to other federal health care programs. Attorney General Martha Coakley’s office served as the lead representative and negotiator for a coalition representing 36 states and the District of Columbia.

Comments (1)
KevinH
Getting money back is good but if leading executives at Eli Lilly intentionally covered up the diabetes side effect of Zyprexa, shouldn't they be criminally prosecuted for intentionally harming and even killing people?

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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.

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Wednesday, May 13, 2009

Scholars discuss 'medicalization' of formerly normal characteristics

www.news.harvard.edu/gazette/2009/04.30/99-medhum.html
Harvard Gazette
April 30, 2009

By Corydon Ireland

Harvard News Office

Not long ago, a majority of Americans described themselves as "shy," a condition of reticence or caution that for ages just seemed natural.

In a discourse on blushing, Darwin thought of shyness — "self-attention" — as an adaptive trait. In a poem, Emily Dickinson described it as something that follows emotional pain: "a formal feeling comes — / The Nerves sit ceremonious, like Tombs."

But in the past two decades, shyness has darted out of the realm of the ordinary and into the medical books. Now a shy person might be suffering from "avoidant personality disorder" or a list of other anxiety-related mental ailments first described in 1980.

That was the year an expanded edition of the "Diagnostic and Statistical Manual of Mental Disorders" was published — the third edition of the American bible of psychiatric disorders. (A fourth has since appeared.)

Of the 112 new disorders described in DSM-III, seven related to shyness or social anxiety.

In 1979, shyness had no medical status, but by 1993, it had been elevated to the third-most-common mental disorder in the United States after depression and alcoholism. And the treatment? Antidepressants — for which 200 million prescriptions are written every year, earning drug companies over $10 billion annually.

The transformation of shyness from blushing to a bona fide illness is an example of medicalization — a complex social, moral, medical, and economic phenomenon that in the past century has widened the definition of disease.

It was the subject of a four-hour Harvard conference last week (April 22) in Emerson Hall, jointly sponsored by the Humanities Center at Harvard and the A. Bernard Ackerman Endowment for the Culture of Medicine. Presenting lectures and sitting on panels were a gathering of experts in history, the law, medicine, social studies, and literature.

Christopher Lane, a scholar of Victorian literature at Northwestern University, offered up a lecture on the medicalization of shyness, drawn from his bestselling 2007 book, "Shyness: How Normal Behavior Became a Sickness."

In it, he quotes Darwin on blushing, and Dickinson on nerves sitting ceremonious. Lane also wonders aloud on what the medical fate of two other famously shy writers (Henry David Thoreau and Nathaniel Hawthorne) might have been in a medicalized world.

How did bad breath become "halitosis," Lane asked, looking out at the audience of about 80, and how did impotence turn into the formalized "erectile dysfunction" — once an accepted consequence of aging that is now the stuff of daytime television?

Medicalization is not the easiest word to understand, he said, but it is the best one to explain so far "a juggernaut which no one seems able to stop."

Behind that juggernaut is a culture-accelerating blend of medicine, marketing, and perceived need that Allan Brandt called "inexorable" and culturally pervasive. (Brandt, who helped introduce the event, is Amalie Moses Kass Professor of the History of Medicine and dean of the Graduate School of Arts and Sciences.)

"Before you sell a drug," said Lane — skeptical of a well-oiled U.S. medicalization machine, "you have to sell an illness."

Harvard Provost and Professor of Neurobiology Steven E. Hyman, who helped introduce the event, acknowledged the dark side of medicalization. Drug companies do sometimes "exploit our credulity in order to turn problems of ordinary living into dread diseases," he said.

And the same companies are capable of making a "trivial chemical modification" to a drug that is about to go off-patent — and reintroduce it as a treatment for something else.

But there is another side to medicalization, said Hyman — the promise of new research and therapies for neglected diseases. (Alzheimer’s, he offered, was once just dismissed as senility.)

"It’s very easy to demonize in an unalloyed way the forces of medicalization," he said — but "there are clearly benefits, liberating benefits, for reconceptualizing some areas as illness."

The Harvard conference explored the wide gray zones of medicalization with other case studies.

McGill University social scientist Jennifer Fishman looked at a hybrid commercial-medical world that is stretching the boundaries of "normal" in aging. Her research explores how the sexual dysfunction that sometimes accompanies normal aging has been commodified — made profitable — in the concept of "successful aging."

Fishman’s investigations, in part, touch on how new diagnoses often emerge in tandem with new drugs; how drugs related to sexual performance have gender implications; and how modern marketing has changed our understanding of medical information.

Direct-to-consumer drug advertising — legal in the United States and New Zealand — "cuts doctors out of the loop," lamented Homi Bhabha, director of the Humanities Center, who introduced the conference. The smooth, soothing voice-overs in medical commercials seem so empathetic, he said, that you feel "better looked after by your television than your GP."

Harvard assistant professor in the history of science Jeremy Greene — a physician-historian who studies the pharmaceuticals industry — said conditions that get treated are sometimes simply dependent on what drugs are available.

As a case in point, he talked about the "therapeutic expansion" of cholesterol-lowering drugs. With the introduction of statin drugs starting in the 1980s, Greene offered, cholesterol was revived as a key risk factor in heart disease. (In the decade before, its relevance had been downplayed.)

Other speakers, including Hyman, touched on the wider social realities of medicalization. (The session was chaired by Arthur Kleinman, the Esther and Sidney Rabb Professor of Anthropology and a professor of medical anthropology and psychiatry.)

"Just as medicalization spreads through life, it spreads through the law," said Martha Field, Langdell Professor of Law at Harvard Law School.

In criminal law, medical debates have arisen over, among other issues, compulsory sterilization and — more dramatically — over the insanity defense. In 1981, the trial of John Hinckley Jr. for the attempted assassination of President Ronald Reagan turned into "a great battle of experts," said Field.

When Hinckley was found not guilty by reason of insanity, she said, the same strategy of defense fell into disfavor with juries.

Field also touched on other arenas of law affected by medicalization: disability, reproductive rights, assisted suicide, the murder of defective newborns, the biological underpinning of homosexuality, and identity disorders that seem to demand surgical intervention.

Nancy Krieger, professor of society, human development, and health at the Harvard School of Public Health, offered an "ecosocial perspective" on medicalization.

Public health, she asserted, often adopts a "narrowly bio-medical perspective," neglecting what her research has shown: that "injustice, not biology," is the source of health inequities.

Some historical perspective came from Charles Rosenberg, Harvard’s Ernest E. Monrad Professor of the Social Sciences.

"Disease specificity," he said, is "a very recent historical phenomenon" — and being more specific about naming diseases may have thrust us into a hundred years of an "increasing bureaucratic imperative" of medicalization.

"Disease perspectives are narratives," and are subject to continuing fluidity, said Rosenberg.

But humans remain "individual moral actors," he said. "We are shaped by our diseases. We are not reduced to them."