Posts Tagged ‘drug industry’

ONE DRUG TO MAKE YOU HAPPY

Monday, November 28th, 2011

NewsWithViews.com – 11/28/2011
by Jonathan Emord, Constitutional Attorney and Author

Psychiatric drugs are big sellers. They are among the best selling drugs made. In 2010, Americans or their insurers doled out some $16.1 billion for anti-psychotics; $11.6 billion for anti-depressants; and $7.2 billion for ADHD treatments.

Within the last two decades the field of psychiatry has mushroomed from a fringe body of Sigmund Freud admirers to a mainstream player in the field of medical pharmacology, largely because of an unseemly union between that profession and the drug industry, leading to the creation of many never before known disease states and profitable ways to exploit those alleged diseases with psychiatric services and drugs.

The field of psychiatry has persistent and well-informed critics who point to the excessive drugging of institutionalized patients, of children commonly misdiagnosed as suffering from Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder, and of the elderly misdiagnosed with treatable dementia, among others. The drugs given these patients have their own side-effects, including increased risk of depression, suicidal thoughts, birth defects, and even death. Because of the movement of psychiatry from the fringe of medicine to its heart, a majority of Americans are likely to come into contact with psychiatric drugs, either recommended for use by their children or for use by them at some point in their lives. Indeed, presently some 1 in 5 adults take anti-depressants, anti-psychotic, or anti-anxiety drugs.

The next edition of the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM-5), the profession’s so-called diagnostic bible, will soon be published in 2013. It comntinues the trend of identifying as “diseases” conditions that have previously been considered within the normal range. It adds to the list of “disease” states “apathy syndrome” (i.e., not caring enough); “internet addiction disorder” (i.e., liking the web too much); “parental alienation syndrome” (i.e., not liking your parents enough); “mild neurocognitive disorder” (i.e., age-related decline in mental function); “absexual” disorder (i.e., disliking sex); and “sluggish cognitive tempo” (i.e., daydreaming too much). Characteristics that we all used to think within the realm of normal brain function (such as teenage angst at parental rules; parental angst at teenage rebellion; a loss of quick wittedness in the elderly; youthful exuberance or youthful preoccupation with daydreams beyond the confines of academia) are all fast becoming “diseases.” The APA’s overall movement has been one of calling into question characteristics of eccentricity, leading to an unscientific conclusion that anything different may be rightly called a disease and rightly prescribed a treatment.

Every newly identified psychiatric disorder begets a new slate of psychiatric drugs for their treatment, giving leading pharmaceutical companies new opportunities to profit from the expansion of psychiatric diagnoses.

Psychiatric drugs are big sellers. They are among the best selling drugs made.

In 2010, Americans or their insurers doled out some $16.1 billion for anti-psychotics;

$11.6 billion for anti-depressants;

and $7.2 billion for ADHD treatments.

Profit lies in designing drugs for the treatment of these conditions. As the drug industry continues to pump out new elixirs that, in turn, leads to more reliance on psychologists and psychiatrists, which leads them in turn to prefer identifying more conditions as disease. The perverse incentives abound, and the FDA is pleased to approve the drugs at the behest of the drug company sponsors.
Everyone standing to profit from the sale of these agents wins at the expense of patients.

The drugging of America is an enormous problem, having spill-over effects that include drug addiction and destruction of the family, productivity, even national security. With an ever rising population taking these drugs which alter cognitive function, it becomes ever more apparent that the very fabric of our society, its common commitment to stable family life, self-sacrifice for the greater good, and adherence to laws that protect life, liberty, and property are all imperiled. As the drug industry and psychiatric profession profits enormously with each new declared disease state, there is a loss of free agency in the population, a movement that saps self-control from the individual in favor of control by the medical community over basic life-affecting decisions. Patients become dependent, event addicted, to drugs, and ever more dependent on their medical counselors to cope with life.

Whatever may be said for use of psychiatric drugs in those who cannot function in society, the expansion of those drugs to embrace those who can, including those with virtually any characteristic that exceeds the norm, represents a horrific sacrifice of the very promise of life that lies in those eccentricities. It is particularly horrific to watch beautiful, energetic children with all their great promise become addicted to drugs that alter brain chemistry in ways that yield drug dependency and lessen their perception of and enthusiasm for life and their ability to achieve. A majority of children prescribed anti-depressant and anti-psychotic drugs are wrongly prescribed those drugs, even by accepted psychiatric standards. That misguided course is itself a form of deviant behavior by this profession, calling into question the mental stability of those who would profit off of misdiagnosis and mistreatment.

The psychiatric drugging of America is bearing and will continue to bear for generations to come toxic consequences, whether in the form of the destruction of the family, increases in crime, or decreases in productivity and inventiveness. It’s high time for a rebellion against this drugging for the sake of sanity.

http://www.newswithviews.com/Emord/jonathan220.htm

Jonathan W. Emord is an attorney who practices constitutional and administrative law before the federal courts and agencies. Congressman Ron Paul calls Jonathan “a hero of the health freedom revolution” and says “all freedom-loving Americans are in [his] debt . . . for his courtroom [victories] on behalf of health freedom.” He has defeated the FDA in federal court a remarkable eight times, six on First Amendment grounds, and is the author of Amazon bestsellers The Rise of Tyranny, and Global Censorship of Health Information. He is also the American Justice columnist for U.S.A. Today Magazine. For more info visit Emord.com.

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“Sunshine: Best Rx for good medicine” by U.S. Senator Chuck Grassley

Wednesday, November 24th, 2010
The Daily Nonpareil, November 24, 2010
By  Chuck Grassley, U.S. Senator

As Americans count their blessings during this season of thanksgiving, many of us can be thankful to gather around the holiday table with multiple generations of family and friends. More Americans are enjoying greater longevity and an improved quality of life well beyond retirement. In 21st century America, the bar of expectation has been raised for each successive generation not only to live the American Dream, but also to live longer and healthier than those before us. Many of us can thank modern medicine for creating breakthrough cures and treatments.

As the taxpaying public shoulders a growing share of the nation’s health care spending, it’s important now more than ever to protect the integrity of each tax dollar and strengthen the integrity of the U.S. health care system.

That’s why I’ve focused for the last several years to improve transparency and accountability between health care providers and the pharmaceutical and medical device industries.

In 2004 I began an inquiry regarding the financial ties between Food and Drug Administration advisory board members and the drug industry. Later, I broadened my scope to include the National Institutes of Health in order to assess its effectiveness in monitoring conflicts of interest between the industry and medical researchers.

It became clear more transparency was needed. In my work in public office, I’ve found sunshine to be very effective in revealing problems and promoting good behavior.

Starting in 2007, I led a bipartisan legislative effort to bring transparency to the financial relationship between drug and medical device makers and doctors conducting research or practicing medicine.   My “Physician Payments Sunshine Act,” which became law this year as part of health care reform, will require all payments above $10 from drug and device makers to physicians to be reported every year by the drug or device company. A user-friendly data base will be available to the public, so that anyone can see industry payments to physicians prescribing treatments and medical researchers conducting studies whose outcomes can significantly influence the commercial success of a drug or device.

The pharmaceutical industry spends tens of billions of dollars every year to market its products to providers. Some physicians receive industry payments for speeches, consulting activities, travel and research. While these payments are often a good and necessary part of drug development, they can also create bad behavior when kept hidden from the public.

In the past few years, congressional investigations and state gift disclosure laws have raised eyebrows about these financial connections, especially where the amount that has been publicly reported is vastly less than what has actually been paid. For example, a congressional review I led from my position on the Senate Finance Committee revealed a troubling financial link between a drug maker and a child psychiatrist at Harvard, whose work led to a significant spike in diagnoses of pediatric bipolar disorders and prevalent use of antipsychotic medicines for children.

Separately, an orthopedic surgeon at the University of Wisconsin received more than $19 million from a medical device company, although he reported only receiving “more than $20,000” per year on his financial disclosure records to the university.

My sunshine legislation that’s now law will require the pharmaceutical and device industries to collect information on their payments to physicians beginning in 2012 and submit it to the Department of Health and Human Services by March 2013 and annually thereafter. The Department of Health and Human Services is required to make that payment information available to the public starting in September 2013. Some within the industry already are developing self-reporting requirements in response to the effort.

While I’m glad to see companies, manufacturers, universities and even the National Institutes of Health are getting a head start to increase disclosure, I’m concerned the information could create even more confusion because the data is not standardized.

That’s why I am working closely with the Department of Health and Human Services to ensure the implementation of the sunshine law works as intended. That means the data must be made available in a timely, user-friendly format.

This effort has been part of my continued work to build openness and establish accountability for taxpayers. Banning anonymous “holds” in the U.S. Senate would shine the light of day on lawmakers who delay the people’s business. I’ve said lawmakers who take issue with a specific bill or nomination ought to have the guts to stand up and say so.

Likewise, creating a meaningful database of financial ties between Big Pharma and medical researchers ought to strengthen our health care system. Financial ties should withstand the light of day.

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Vatican City— Catholic Church Called On To Counter Corporate Greed Fueling Harmful Psychiatric Drugging of Children

Friday, November 19th, 2010

Catholic News Service, November 19, 2010

by Rita Fitch

photo: Graur Ionut

VATICAN CITY – The Catholic Church may be the only organization that can counter the corporate greed fueling the over-prescribing of harmful psychiatric drugs to children and young people, said Dr. Barry Duncan, a clinical psychologist and director of the Heart and Soul of Change Project.

Flawed methodologies in research and a drastic minimization of actual risks make the cited efficiency and safety of these drugs untrustworthy, he told a meeting of the Pontifical Council for Health Care Ministry.

And clinical trial evidence on psychiatric drugs is often skewed by conflicts of interests, particularly when trials are funded by the drug industry or when the studies are conducted by people who are paid consultants of the company under review, Duncan told the Nov. 18-19 meeting.

He said because of the church’s broad networking capabilities and international influence, it “may be the only power on earth that can counter the forces of corporate greed that have no moral or ethical conscience.”

He called on religious orders, Catholic schools, hospitals, medical associations, media and parishes to become informed and help children and families discover alternatives to psychiatric medications as well as help them have real input when discussing the risks and benefits of such medication.

Duncan spoke Nov.19 on “The Question of the Use of Psychiatric Pharmaceuticals in Pediatrics” during the conference, and he spoke about his findings in a separate meeting Nov. 18 with Cardinal Ennio Antonelli, president of the Pontifical Council for the Family.

Duncan told the conference that the United States leads the world in the number of psychiatric prescriptions to young people and that the trend to resort to antipsychotics before or in lieu of social and behavioral therapy is on the rise in Europe.

Most disturbing, he said, is that poor children in the United States, particularly those in foster care or on Medicaid, are four times more likely to be prescribed antipsychotic drugs and six times more likely to be treated with a number of different psychotropic medications.

Poor children are also “vulnerable to dangerous drugs used as interventions of control rather than therapy,” he said.

Clinical evidence does not support the practice of prescribing pharmaceutical drugs as a first response to behavioral or psychiatric issues, he said, not only because of the drugs’ questionable long-term effectiveness, but also for the risk of serious health consequences, dependence and disability.

“The belief in the power of chemistry over church, community, social and psychological process – fueled by unprecedented promotion from the drug industry that targets all players in health care – forms the basis of pharmacology’s growing centrality in treatment, research, training and practice,” he said.

Children have no voice, and they rely on adult judgments and decisions for their well-being, he added.

Families, pastoral workers, pediatricians and health professionals “need access to accurate data – to the truth untainted by corporate influence,” Duncan said.

http://www.catholicreview.org/subpages/storyworldnew-new.aspx?action=9117

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Drug Industry’s Boast of Ethics Rings Hollow

Thursday, September 16th, 2010

The Star Phoenix, September 16, 2010

by Mark Lemstra

Russell Williams, president of Canada’s Pharmaceutical Companies, recently wrote an opinion piece criticizing a series of articles that I wrote on antidepressants. His article was headlined: “Drug industry ethical standards high.”

Curiously, Williams did not address my concern that a review from the United States Food and Drug Administration found that antidepressants not only have no benefit in children, but are associated with a 50 per cent increase in suicidal behaviour.

Regrettably, these negative results were buried by the drug companies. In an editorial in the Canadian Medical Association Journal, titled Drug Company Experts Advised Staff to Withhold Data about SSRI Use in Children, and a separate editorial in The Lancet, titled Depressing Research, the authors express regret that drug companies put profits ahead of preventing suicides among children.

I fail to see the high ethical standards in these actions. In fact, it would be easy to list all of the unethical activity by pharmaceutical companies, but this would take a whole book. Instead, let’s discuss one specific example in detail.

Read more: http://www.thestarphoenix.com/health/Drug+industry+boast+ethics+rings+hollow/3532133/story.html#ixzz0zi3tRIIc

http://www.thestarphoenix.com/health/Drug+industry+boast+ethics+rings+hollow/3532133/story.html

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BNET: ‘The Dog Ate AstraZeneca’s Homework! Evidence on Misleading Drug Ad Disappears From Company’s Files’

Wednesday, July 7th, 2010

BNET
By Jim Edwards
July 7, 2010

AstraZeneca (AZN) says it has lost a crucial internal document that would explain how an ad for its antipsychotic Seroquel misleadingly claimed there was “no weight gain” with the drug and described its “favorable weight profile.” But the company admits it kept the six-year-old envelope that once allegedly contained the ad’s approval certificate, according to a ruling by the U.K.’s Prescription Medicines Code of Practice Authority.

The drug industry watchdog also alleges AZ’s Seroquel management team “pressured and manipulated” executives around them in order to make sure negative data on Seroquel was buried. The PMCPA ruled that AZ had breached its code of practice, which requires companies to operate in “a professional, ethical and transparent” manner.

If there’s a lesson here for managers, it’s this: Simply winning the legal war isn’t good enough. Consumers — and your own employees, as the Seroquel case shows — expect companies to go above and beyond. (AZ has mostly won the litigation filed against it which alleges the company failed to warn patients that Seroquel causes weight gain and diabetes. It settled with the Department of Justice for $520 million.)

Many of the allegations in the PMCPA case are familiar, but what’s new is the source: One of the complainants was an unnamed male former AZ executive, employed at the company from 1992 to 2001, who from 1995 to 2000 was responsible for the medical aspects of the U.K. launch and subsequent marketing of Seroquel.*

In terms of the ad, the BBC reported in January that AZ had published a misleading ad in the British Journal of Psychiatry in April 2004. The PMCPA asked AZ to produce all the documentation behind the ad. Here’s its characterization of AZ’s response:

… for a product that had been marketed for more than 12 years in the UK, the company did not believe that it could reasonably investigate and respond to such a broad request in relation to specific clauses of the code.

The Code requires companies keep relevant documents for three years, AZ argued, and the ad itself was at least five years old, thus, “AstraZeneca had been unable to produce the certificate approving the advertisement from its archive.” But:

The Appeal Board noted from the AstraZeneca representatives at the appeal that although the job bag for the advertisement at issue still existed, it did not contain the relevant certificate.

How unfortunate!

More seriously, the PMCPA appeared to take seriously the ex-employee’s allegation that AZ buried or manipulated data on Seroquel long after the company became aware of weight-gain effects on its patients. The executive alleged that in 1997 he was told by a colleague…

Read entire article here:  http://industry.bnet.com/pharma/10008835/the-dog-ate-astrazenecas-homework-evidence-on-misleading-drug-ad-dissappears-from-companys-files/

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