ProPublica
By Charles Ornstein and Tracy Weber
January 24, 2012

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The New York Times – January 16, 2012

by Robert Pear

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul. “The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.

Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Federal officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.

The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.

The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.

Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.

Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.

The new requirements, or something very similar, will take effect soon; in fact, they are overdue. Under the new health care law, the administration was supposed to establish payment-reporting procedures by Oct. 1, 2011. The public will have until Feb. 17 to comment on the proposals, which are broadly consistent with the expectations of industry and consumer groups. After considering the comments, Medicare officials will issue final rules with the force of law.

Consumer advocates have long demanded details of the financial ties between doctors and drug and device companies.

Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”

In an introduction to the proposed rules, the Obama administration says that patients can benefit when doctors and the industry work together to develop life-saving drugs and devices. But, it said, these relationships can also “lead to conflicts of interests that may affect clinical decision-making” and “threaten the underlying integrity of the health care system.”

The administration does not try to define the difference between proper and improper payments. It says simply that public reporting of the financial ties between doctors and drug and device companies “will permit patients to make better-informed decisions when choosing health care professionals and making treatment decisions.”

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul.

“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.

“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said.

Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.

Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing.

As an example of inappropriate payments, the inspector general of the Department of Health and Human Services cited a case in which manufacturers of medical devices had provided financial incentives — in the form of consulting agreements, lavish trips and other perks — to induce doctors to use particular hip and knee replacement products. Under a civil settlement with the government, the companies agreed to new compliance procedures.

The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks.

The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery.

http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=2&pagewanted=all

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New York Times November 24, 2011

The financial relationships raise questions about the influence of drug companies on prescribing patterns or research results. The practice “puts patients and tax dollars at risk,” said Lee Spiller, the policy director for the Texas branch of the Citizens Commission on Human Rights,  a nonprofit mental health watchdog. “It taints the whole process. I’d hate to think donations were shaping state mental health policy in particular.”

State records show that of the 74 doctors and psychiatrists statewide who have routinely prescribed the highest number of costly antipsychotic drugs to patients on Medicaid, the joint state-federal health insurance program for the disabled, children and the very poor, 10 received payments from drug companies in 2009-11 — from $11,000 to $180,000 each.

By EMILY RAMSHAW and RYAN MURPHY

Published: November 24, 2011

Thousands of Texas doctors, researchers and medical experts — including more than 100 who are employed by the state and are paid with taxpayer dollars — routinely supplement their salaries with income from pharmaceutical companies.

Drug companies pay medical professionals for a wide range of activities, from speaking engagements to consulting. While legal, the practice raises questions about potential conflicts, and whether the interests of patients may be compromised.

From 2009 to early 2011, at least 25,000 Texas physicians and researchers received a combined $57 million — and probably far more — in cash payments, research money, free meals, travel and other perks, according to data culled from 12 drug companies and provided by the nonprofit investigative news organization ProPublica.

Dozens of these medical professionals were paid more than $100,000 each during that period. And 114 were professors, physicians, psychiatrists or researchers who were already paid a salary by the state — in some cases more than a half-million dollars a year. These state employees brought in nearly $3 million combined from pharmaceutical companies from 2009 to early 2011, according to a Texas Tribune analysis of the ProPublica data.

Nationwide, pharmaceutical manufacturers routinely pay medical professionals to assess a new product or to help contribute to the drug company’s sales. The companies fly medical professionals to seminars and conferences and may also pay speaking fees. State-employed doctors and researchers are generally no exception, though they are supposed to comply with their individual institutions’ conflict-of-interest policies.

“It’s important to state out of the gate the importance of these interactions, the value they bring to physicians, to health care professionals in general and ultimately to patients,” said Karl Uhlendorf, vice president of Pharmaceutical Research and Manufacturers of America.

But the financial relationships raise questions about the influence of drug companies on prescribing patterns or research results. The practice “puts patients and tax dollars at risk,” said Lee Spiller, the policy director for the Texas branch of the Citizens Commission on Human Rights, a nonprofit mental health watchdog. “It taints the whole process. I’d hate to think donations were shaping state mental health policy in particular.”

Dr. Stanley Self, a part-time psychiatrist at Texas’ state-run Rusk psychiatric hospital, earns $166,000 a year from the state. He also earned at least $145,000 from drug companies in 2009-10, largely for speaking engagements. Dr. Self did not return calls seeking comment on his work for drug companies, but his receptionist said he is “not doing much of that anymore.”

Christine Mann, a spokeswoman for the Department of State Health Services, said agency employees, like Dr. Self, are allowed to hold a second job as long as there is not a conflict of interest. The agency “is looking into this issue further and will examine its policies to see if there are provisions that need to be strengthened,” Ms. Mann said.

Dr. Joseph Bailes, an oncologist and the vice chairman of the executive committee at the Cancer Research and Prevention Institute of Texas, earned roughly $250,000 between 2009 and 2010 as a consultant for Pfizer. Dr. Bailes said that he has advised Pfizer on Medicare policy — not on drug development — and that it has no bearing on his role with the institute, a $3 billion endeavor financed by voter-approved bonds, for which he is an “unpaid volunteer” specializing in efforts to bring new cancer therapies to market.

“It doesn’t influence anything I do,” Dr. Bailes said, adding that his committee is not responsible for selecting projects for financing.

Dr. Stanley Lemon, who left his post as the director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch in April and is now at the University of North Carolina, made nearly $80,000 consulting for Pfizer in 2009-10. Dr. Lemon, who is still an adjunct professor at U.T.M.B. but is no longer on the state payroll, said consulting for the pharmaceutical industry has enriched his academic life and made him a more productive scientist.

“As long as they are properly reported and do not engender conflicts of interest or commitment, such interactions between industry and academia help to move drug development forward in a positive way,” Dr. Lemon wrote in an e-mail.

The analysis of Texas pharmaceutical payments comes as the state attorney general’s office prepares for a mammoth trial in January against Janssen Pharmaceuticals and its parent company, Johnson & Johnson. Janssen, which has vigorously denied any wrongdoing, has been accused of offering trips and kickbacks to state health officials to get the schizophrenia drug Risperdal on an approved drug list for medications that are paid for by the state.

Across the country, the reporting of such perceived conflicts has traditionally fallen short. Companies have not been required to disclose payments, and medical institutions have made limited efforts to police their employees.

The ProPublica data covers just a part of drug company payments — it represents about 40 percent of the 2010 pharmaceutical market in the United States — and includes manufacturers that have either begun disclosing their payments voluntarily, or as a result of legal settlements.

Beginning in March, federal law will require drug and device companies to report and disclose all of their payments to medical professionals and researchers; by September, the data is supposed to be displayed in a searchable online government database. Texas universities — whose doctors and researchers account for $2.7 million of the pharmaceutical money statewide from 2009 to early 2011 — are working to update their own conflict policies and monitoring systems.

The University of Texas System will require its faculty members to report every dollar they are paid by a drug or device manufacturer and all financial interests in their research beginning Jan. 1.

The U.T. Southwestern Medical Center in Dallas is working on an electronic conflict-of-interest filing system that will feed into a soon-to-be-released public disclosure Web site, said Tim Doke, U.T.-Southwestern’s vice president for communications.

“We’ve been working feverishly here for the last couple of months,” Mr. Doke said. “Transparency is the absolute key to the public being confident that conflicts that exist are being managed appropriately.”

At the University of Texas MD Anderson Cancer Center in Houston, university administrators monitor drug company databases to ensure that faculty-conflict filings match, and to set limits on how much doctors and researchers can accept, said Dr. Raymond DuBois, the center’s provost and executive vice president.

But such efforts at transparency vary widely depending on the institution, or may be nonexistent when there is no institution at all. State records show that of the 74 doctors and psychiatrists statewide who have routinely prescribed the highest number of costly antipsychotic drugs to patients on Medicaid, the joint state-federal health insurance program for the disabled, children and the very poor, 10 received payments from drug companies in 2009-11 — from $11,000 to $180,000 each.

All but one got the payments from the maker of the drug they most commonly prescribed.

http://www.nytimes.com/2011/11/25/us/payments-to-doctors-by-pharmaceutical-companies-raise-issues-of-conflicts.html?_r=1

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Click image to watch Psychiatric Drug Side Effects

4-year-olds on drugs? You betcha.  The  American Academy of Pediatrics issued new treatment guidelines for “Attention Deficit Hyperactivity Disorder” that say ADHD can be diagnosed in kids as early as age four, and that Ritalin and similar drugs are an appropriate treatment even for children this young. Apparently the “Academy” has no problem with the fact that the US FDA warns drugs like Ritalin can cause hallucinations, mania, heart attack, stroke and sudden death. Nor do they consider it a problem that a diagnoses of “ADHD” is based solely on a checklist of behaviors such as “loses pencils or toys,” “often does not seem to listen,” “is easily distracted by extraneous stimuli,” “fidgets” or “runs about or climbs excessively in situations when it is not appropriate.” And for this, children as young as four should be placed on drugs that the U.S. Drug Enforcement Administration categorizes in the same class of highly addictive drugs as cocaine, morphine and opium?

Right.

It should come as no surprise that the chairman of the new ADHD guidelines, Mark Wolraich, MD, is a periodic consultant to Shire Pharmaceuticals,  Eli Lilly, Shinogi, and Next Wave Pharmaceuticals, or that the American Academy of Pediatrics (AAP) has received millions in pharmaceutical funding—In 2011,they received $30,000 from Pfizer; $100,000 from Eli Lilly; and $79,650 from Merck. In 2010, they received $297,750 from Pfizer; $100,000 from Merck; and $3,000 from Shire. Between 2008 and 2009, AAP received another $69,000 from Pfizer. 

This isn’t the first time the AAP has come under fire for promoting a pharmaceutical agenda – in 2008, they were exposed for their  financial ties to the pharmaceutical industry, when the academy issued guidelines recommending statins (cholesterol lowering drugs) for kids, after it was disclosed they had received substantial contributions from pharmaceutical companies with ties to statins, including $433,000 from Merck, $835,250 from Abbott Laboratories’ Ross Product Division and $216,000 from the Bristol-Myers Squibb company Mead Johnson Nutritionals.

Here are the only guidelines (also known as facts) that the AAP should be issuing:

1) There is no medical or scientific test that can validate ADHD as a medical condition or disease.  Not one.  Diagnoses is 100% subjective and means nothing in medical terms.

2) 12 International drug regulatory agencies have issued warnings on ADHD drugs such as Ritalin causing depression, insomnia, mania, hallucinations, psychosis, heart attack, stroke and sudden death. The US DEA places Ritalin in the same category of highly addictive drugs as morphine, cocaine and opium.

3) No child should ever be subjected to mind-altering, life threatening drugs based solely on a checklist of behaviors. Period.

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The News Tribune – September 20, 2011
by Tracy Weber and Charles Ornstein; ProPublica

Despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians

Two years ago, drugmaker Eli Lilly pleaded guilty to illegally marketing its blockbuster antipsychotic Zyprexa for elderly patients. Lilly paid $1.4 billion in criminal penalties and settlements in four civil lawsuits.

But a doctor named as a co-defendant in one suit – for allegedly taking kickbacks to prescribe the drug extensively at nursing homes – never was pursued.

Last year, Alpharma paid $42.5 million to settle federal allegations that it paid kickbacks to doctors to prescribe its painkiller Kadian.

“Health-care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” Rod Rosenstein, U.S. attorney for the District of Maryland, said in a statement announcing the settlement.

But the doctors, accused of trading prescriptions for paid speaking gigs, faced no consequences.

At least 15 drug and medical-device companies have paid $6.5 billion since 2008 to settle accusations of marketing fraud or kickbacks. However, none of the more than 75 doctors named as participants was sanctioned, despite allegations of fraud or of conduct that put patients at risk, a review by ProPublica found.

Reporters reviewed hundreds of pages of court records and interviewed current and former federal prosecutors, state medical board officials, attorneys for whistle-blowers and, when possible, the doctors. For each doctor identified in a suit, ProPublica checked for state medical board discipline, penalties from the Medicare program and federal criminal charges.

In many of the cases, it appears that not even a cursory investigation was done to see whether the physicians had behaved inappropriately.

“Doctors have kind of gone under the radar,” said Tavy Deming, a Philadelphia lawyer who represents drug company whistle-blowers.

Amid concerns about the influence of drug company money on medicine, whistle-blower lawsuits have emerged as a headline-grabbing tool for holding manufacturers accountable.

Yet, despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians. Doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the suits. And even when settling, many companies, including Alpharma, continue to deny the allegations.

After cases are resolved, the internal company documents used as evidence remain confidential, preventing further exploration of the physicians’ behavior. Patients have no way of knowing whether their doctor’s judgment has been compromised, and doctors might be tarnished by spurious accusations.

Medical boards, which normally pursue tips or complaints of wrongdoing, do not routinely scan for such cases. Justice Department lawyers, wary of spending more time and effort on a case, say they usually are not interested in going after lesser players.

Tony West, the assistant attorney general who oversees civil litigation nationwide for the Justice Department, declined through a spokeswoman to discuss the issue. In announcing settlements with the drug companies, however, West has said that kickbacks undermine doctors’ credibility. Medical decisions, he said in one news release, should be “guided by a patient’s needs, not tainted by illegal incentives or fraud.”

Sen. Charles Grassley, Iowa, the ranking Republican on the Judiciary Committee, said in a written statement that it takes “two sides to perpetuate this fraud” and that both need to be held accountable.

“Otherwise, regardless of how big of a civil settlement a drug company makes, the incentive to cheat the taxpayers will still be in place for those willing to take part,” said Grassley, who has led investigations into conflicts of interest in medicine.

In recent years, pharmaceutical and medical-device companies have been barraged by whistle-blower lawsuits detailing how the pursuit of profit allegedly fueled fraud and corruption.

The suits are typically filed by former employees who say the companies promoted drugs for unapproved uses or paid doctors to prescribe drugs or use medical devices. The suits seek to recover millions – even billions – of dollars spent on these products by government health programs.

For Justice Department lawyers, big drug companies make attractive targets. They are flush with profits and determined to avoid crippling legal defeats. Their bureaucratic sprawl often leaves a trail of incriminating email and memos.

The massive financial settlements they are willing to pay are often modest in light of their annual sales and profits. Zyprexa, for example, had U.S. sales of nearly $3 billion in 2010. Kadian, Alpharma’s painkiller, brought in nearly $263 million, according to IMS Health, which tracks prescription drug sales.

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PMLive
August 30, 2011

A report by the Financial Times has claimed a group of pharmaceutical companies has paid doctors in the US almost $150m so far during 2011.

Prepared in conjunction with the data provider, PharmaShine, the figures show the money was paid by pharmaceutical firms, including Eli Lilly, AstraZeneca (AZ) and Pfizer, for doctors’ travel and entertainment expenses as well as education and consultancy fees.

Of those companies who have released data, Lilly is reported to have paid $48m and Pfizer to have paid $42m.

AZ, who recently launched a database containing payments made to doctors and institutions, said $24.7m was paid out in associated compensation for the second quarter of 2011, with $8.1m going to individual physicians and $16.6m going to institutions.

In a post on the company’s AZ Health Connections blog, US compliance officer, Marie Martino, gave reason as to why the company was releasing its data.

She said: “AstraZeneca believes it is important to be open about how we conduct our business, and this new reporting expands on a major initiative announced three years ago to provide greater public visibility into how we do business.”

Around 165,000 doctors have received related payments in 2011 so far, compared to 262,000 doctors who received payment in 2010.

The report comes at a time when US government agencies are preparing guidelines to make the publication of industry support for medical professionals compulsory by 2013.

This is part of ongoing US healthcare reforms as an attempt to allow better, more consistent understanding of the pharmaceutical industry’s relationship with healthcare professionals in the US.

In the UK, the Association of the British Pharmaceutical Industry (ABPI) changed its code of practice at the beginning of 2011 to help increase transparency of working practices between the pharmaceutical industry and healthcare professionals to help increase trust.

Companies will have to declare payments to healthcare professionals for services including speaker fees, advisory boards and consultancy, and sponsorship for attendance at meetings on an annual basis. The first declaration will be made in 2013 for payments made in 2012.

http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/august_2011/news/big_pharma_pays_us_doctors_$150m_in_2011

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From Project on Government Oversight:

In recent years, Senator Grassley exposed several academic physicians for taking large amounts of money from companies with a direct financial interest in their research, some of it funded by the NIH. The list reads like a who’s who in academic research:

• Dr. Charlie Nemeroff, former Chair of the Psychiatry Department at Emory University, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant.  Dr. Nemeroff was bounced from Emory and has now taken over the Chair of Psychiatry at the University of Miami.

• Dr. Alan Schatzberg, former Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. An NIH oversight group recommended that Stanford’s clinical trial on mifepristone be “terminated immediately and permanently.”  The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.
• Dr. Joseph Biederman and two other researchers at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard later disciplined the three physicians.

US health agency revises conflict of interest rules

From Reuters – August 23 – 2011

by  Alina Selyukh

WASHINGTON,  – The U.S. National Institutes of Health revised on Tuesday its 16-year-old conflict of interest rules for medical researchers, lowering the amount of money that constitutes a financial conflict and expanding the required disclosures.

The 1995 regulations effectively put responsibility for tracking scientists’ financial conflicts of interest on their universities. The rule required researchers to disclose conflicts to their institutions, which then had to assure the NIH the conflict had been managed, reduced or eliminated.

The new rule extends that requirement so researchers report not only the fact of a conflict of interest, but also its details such as value, specific nature, why it is a conflict and the impact it might have on research.

It lowers the amount a researcher must disclose if received from an industry or held in company stock to $5,000 from about $10,000.

Research institutions, in turn, are now required to report that information to the federal grant-awarding agency alongside details of how the conflicts are managed. Also, before spending any grant money, the institution has to post information about the financial conflicts on a public website.

The new rules will affect about 2,000 organizations that are awarded public health science funding every year and some 38,000 scientists who participate in research funded by these grants and have a “significant financial interest,” NIH said.

Concern about the integrity of research in the United States has grown since 2008, when Iowa Republican Sen. Charles Grassley criticized prominent Harvard University psychiatrist Dr. Joseph Biederman and others for failing to fully disclose payments from drug companies.

In a more recent example, medical device maker Medtronic Inc (MDT.N) came under fire over accusations that doctors paid by the company had failed to disclose major side effects from a bone growth drug in clinical trials.

A 2009 report by the Institute of Medicine, one of the National Academies of Sciences that advises U.S. policymakers, called on doctors to strictly disclose research funding to strengthen protection against conflicts of interest. The report called for virtually anyone involved in medicine — academic medical centers, journals, professional societies, researchers and doctors — to set up or strengthen conflict of interest guidelines.

From 1996 to 2007, relationships between individual academic researchers and industry nearly doubled, according to a study cited by NIH in its final rule. From 1994 to 2003, the amount of financial support for biomedical research almost tripled to $94.3 billion, with 57 percent of that funding coming from industry sources, according to analysis cited by NIH. (Additional reporting by Anna Yukhananov; editing by Andre Grenon)

http://www.reuters.com/article/2011/08/23/health-science-conflicts-idUSN1E77M1PB20110823

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NaturalNews -  August 15, 2011

by Christina Luisa

There is a good chance you have heard the story of Maryanne Godboldo and how armed government agents broke down her door and attempted to kidnap her 13-year-old daughter Ariana to turn over to CPS because she refused to medicate her with a potentially dangerous and mind-altering anti-psychotic drug Risperdal (http://www.naturalnews.com/032191_C…). Maryanne had been using holistic remedies for her daughter instead, such as dance therapy.

The Detroit mother is now currently going through a criminal and custody trial because of this incident, and a variety of revealing and disturbing information is starting to come out about the involvement of Big Pharma and other parties in the twisted web of lies the case is wrapped in.

The jury presiding over the hearing was convinced to believe that Maryanne’s refusal to give her daughter the controversial drug, supposedly used to “treat” ADHD, represented a form of parental neglect. Read more here: http://www.naturalnews.com/033295_p…

Thanks to the Voice of Detroit (VOD), it is now coming to light that the New Oakland Child-Adolescent & Family Center – a private facility which reported Maryanne to CPS for taking her daughter off the drug — has paid connections with Big Pharma since at least 2004.

Pharmaceutical companies were involved all along

According to the Center’s website, Kimberly Smith — Director of Pharmaceutical Research for all its facilities since 2004 — provides “clinical support and supervision” for the Clinton Township facility. She is also the head of the Center’s Office of Recipient Rights. The website openly says that Kimberly has been coordinating Adult and Pediatric CNS (Central Nervous System) Clinical Trials for a number of big pharmaceutical companies for the last ten years.

Smith was recently contacted by VOD at her office, and she admitted that not only is she paid by the drug companies she works with, but that trials she is paid to conduct are among those carried out at New Oakland’s facilities. She refused to give further information on specific drug trials, saying the information was “private.” She claimed reports are only published after the FDA approves a drug, and that a confidentiality agreement must be signed with the company.

However, this statement is not nearly the whole truth, according to the U.S. National Institutes of Health’s website at http://ClinicalTrials.gov. The site indicates that the FDA Amendments Act of 2007 “requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices.” A clinical trial of Depakote that New Oakland recruited participants for was listed on the site while it was still ongoing.

Ms. Smith claimed that parents are required to complete a detailed form when their child participates in such a study, but said she did not have a blank copy of the form she could provide for proof.

Follow the money trail

Even beyond the New Oakland Center’s drug connections, those involved in seizing Ariana – from the judge to the DHS and various public and private agencies involved — are connected to each other in a suspiciously twisted web. All are getting big bucks for not only children they barbarically take from their families, but for clinical trials on psychiatric drugs and medical treatment — including pharmaceutical drugs — that are given to the children.

Government officials involved in the case, including Judge Lynne Pierce, Department of Human Services chief Maura Corrigan and others also have their ties to Big Pharma and the undercurrent of money funneling.

Godboldo first took her daughter to The Children’s Center in Detroit when Ariana began having significant adverse reactions to the immunizations she had been receiving. Maryanne didn’t realize at the time that the Children’s Center is one of six partners in Behavioral Health Professionals, Inc (BHPI), a non-profit based in Michigan. BHPI is the parent organization for ConsumerLink and CareLink, which network with insurance companies and refer children to the various partners and other organizations.

Amber Kozlowski — a “social worker” — testified on Aug. 5 that she was responsible for Ariana’s admission to the Hawthorn Center on March 25. There, Ariana’s prosthesis was removed in violation of her disability rights, she was re-medicated with Risperdal and other drugs and was said to become the victim of sexual abuse, as stated in a police report filed by her family.

According to the Voice of Detroit, Kozlowski said she works for Neighborhood Services Organization (NSO) — one of the partners of BHPI — directly while contracting with ConsumerLink for the hospital liaison part of her job. NSO’s board of directors includes executives from various health and insurance agencies, including the Detroit Medical Center, Pro Care Health Plan and the Health Alliance Plan.

The Children’s Center, which is primarily funded by the Department of Human Services, also has its own foster care division and is funded at the rate of $34 per day for foster care provision, according to state budget documents. These funds originate with the federal government and are also channeled also into various other private foster care agencies in the state.

But that’s not all – the center also receives substantial grants from Ford Motor Company, and three Ford family members sit on its board.

Corruption, lies and illegal action

After authorities seized Ariana and institutionalized her, they decided she didn’t need the medication after all, but still continued to institutionalize her for seven weeks before releasing her to an aunt. Due to Maryanne’s allegedly firing a shot when authorities tried to take her daughter, this case received special attention – but it is otherwise exactly like thousands of other cases like it in Michigan. In the Godboldo case and many others, orders to remove children are literally rubber-stamped.

Voice of Detroit also recently reported that the Interim Supervisor of Juvenile Intake for Wayne County, Vikki Kapanowski, testified at Godboldo’s juvenile court trial that these orders are actually approved by a probation officer with no law license who merely stamps the judge’s name on the order — the judge never even sees the order.

Voice of Detroit and the Detroit News also reported on testimony in Godboldo’s criminal trial revealing that the whole process of serving the illegal order was, in itself, illegal. The probation officers doing this rubber-stamping in Detroit have not been sworn, do not have law licenses and are not authorized to perform functions such as issuing these orders.

CPS has no intentions of protecting children

Everything about this case seems wrong. To begin with, Ariana was not only prescribed a dangerous drug that is restricted to individuals over the age of 18, she had to witness a standoff with a SWAT team because there was no legal court order to remove her. A caseworker lied and called Maryanne’s actions medical neglect, even though she was working out a treatment plan elsewhere with another medical doctor. Ariana was then forced to return to the same facility that she was said to have been sexually assaulted at.

Not only has CPS – an agency sworn to protect children — shown no concern about this child’s best interests in any regard, its insistence on forcing children on medications is the reason why the Godboldo family has been forced to struggle through this ridiculous and unnecessary trial.

Ariana was taken from her mother (a low-income household), who CPS assumed would not be able to afford to defend herself, and was attempted to be placed in a foster home, group home or institution without due process or any evidence to prove that intervention was even necessary to begin with. All the while, federal matching funds and Medicaid funds were being collected to do so.

This case has exposed a serious problem in the way child protection is handled in not only Detroit or in the entire state of Michigan; the sad truth is that this is how child protection is being handled in every city in the country as well. Far from protecting children, CPS frequently exploits children for private gain.

This all comes back to the disturbing truth about the corruption of the agency, and how it uses private contractors to kidnap children and take them from their homes. The private contractors working for CPS are paid up to millions of dollars in reward money a year (http://www.infowars.com/cps-warrior…). Maryanne Godboldo has now openly accused CPS of being engaged in child trafficking (http://www.naturalnews.com/032501_M…) as well as sexually molesting her daughter (listen to interviews below).

Risperdal was unlawfully marketed to children to start with

What is even more interesting about all this information is the timing of recent news reports that Johnson and Johnson has just settled with the Justice Department and agreed to plead a misdemeanor on the illegal marketing of Risperdal ((http://voiceofdetroit.net/2011/08/0…).

Forty US states are planning lawsuits against J&J for this (http://www.pharmalot.com/2011/08/jj…). Johnson and Johnson has been forced to pay millions in damages – in multiple cases – for misleading safety claims it made about Risperdal while marketing the drug, including to children.

Big Pharma’s habit of paying medical professionals to recommend, market and prescribe their products regardless of the consequences is gathering more attention in recent times, such as in the case of Risperdal.

According to one lawsuit filed against the drug company giant, the FDA told J&J in 1997 that its request to market Risperdal for children was “without any justification.” In the following years, J&J’s arsenal of pharmaceutical sales reps made thousands of sales calls to child and adolescent psychiatrists. The company informed doctors that they qualified for the drug if they had as few as one adult patient displaying minor signs of schizophrenia.

Listen to interviews with Maryanne Godboldo here:
http://naturalnews.tv/v.asp?v=8B819…
http://naturalnews.tv/v.asp?v=97774…
http://www.naturalnews.com/033295_p…

More sources/further reading:

http://voiceofdetroit.net/2011/08/0…

http://online.wsj.com/article/BT-CO…

http://www.nccprblog.org/2011/08/fo…

http://www.pharmalot.com/2011/08/jj…

http://online.wsj.com/article/BT-CO…

http://www.mentalhealthrightsyes.or…

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 In a letter to OMB [ Office of Management and Budget]  Sen. Chuck Grassley warned the administration not to back off from a proposed rule that would create a website to disclose medical researchers’ conflicts of interest. “I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers.” Grassley said he’s worked tirelessly “to shine light on these relationships, including with the help of Sen. Kohl in securing the passage of the Physician Payment Sunshine Act of 2009.” Read the letter here: http://1.usa.gov/r0OLYG

The Honorable Jacob J. Lew
Director
Office of Management and Budget
Eisenhower Executive Office Building
1650 Pennsylvania Avenue, NW
Washington, DC 20503

Dear Director Lew:
I write to you today regarding public disclosure of financial relationships between physicians and the drug, device and biologic industries. For the past three years I have worked to shine light on these relationships, including with the help of Senator Kohl in securing the passage of the Physician Payment Sunshine Act of 2009 (PPSA).

Before the passage of PPSA, in summer of 2008, I began releasing the results of my oversight work that demonstrated that universities are not and have not managed their professors’ financial conflicts of interest and that change is needed at the National Institutes of Health (NIH). Specifically, I found:

The Chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company’s drugs with an NIH grant. The Health and Human Services Office of the Inspector General (HHS OIG) is now investigating the matter.

The Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. He was later removed from the grant.

Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard released a report on the matter, and a briefing has been scheduled with my office.
I am concerned about recent reports that the Office of Management and Budget (OMB) may be attempting to weaken conflicts of interest rules proposed in May 2010 by the Department of Health and Human Services (HHS).

According to an article in Nature, OMB has removed the requirement for a publicly available website that would publish the conflicts of interests of researchers funded by taxpayers.1 I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers. Transparency is a backstop against such practices. I urge OMB to follow through and approve a rule that includes a publicly available website. OMB is the final arbiter of this decision. Any weakening of publicly available information requires careful scrutiny.

In order to understand why OMB appears to have concluded that weakening the HHS proposed conflict of interest rule is appropriate, I would appreciate your response to the following requests for documents:

1) Please provide all records relating to communications, including emails, with OMB staff regarding the Department of Health and Human Services’ proposed conflicts of interest rule from May 1, 2010, to the present.

2) Please provide all records, including calendar entries, relating to meetings with Administrator Cass Sunstein, OMB Office of Information and Regulatory Affairs, from May 1, 2010, to the present.

I request that OMB respond to my request by no later than August 25, 2011. Thank you for your attention to this important matter.

Sincerely,
Charles E. Grassley
Ranking Member
See the letter here: http://1.usa.gov/r0OLYG

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Minyanville
By Minyanville Staff
July 28, 2011

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

For any mental illness or passing mood swing that may trouble a person, the Diagnostic and Statistical Manual of Mental Disorders — better known as the DSM — has a label and a code. Recurring bad dreams? That may be a Nightmare Disorder, or 307.47. Narcolepsy uses the same digits in a different order: 347.00. Fancy feather ticklers? That sounds like Fetishism, or 302.81. Then there’s the ultimate catch-all for vague sadness or uneasiness, General Anxiety Disorder, or 300.02. That’s a label almost everyone can lay claim to.

These codes are used by doctors, psychologists, and regulators to maintain a mutual language; it’s a handy shorthand system for bureaucratic purposes. But over the past few decades, the staggering, ever-expanding influence of the ever-expanding DSM, which is published by the American Psychiatric Association, has also played a lead role in building wealth and off-label product uses for the major drug manufacturers. In an insightful essay in this week’s New York Review of Books, Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and former Editor in Chief of The New England Journal of Medicine, explains how.

The medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported."

Angell’s essay is based on a review of three current books examining the psychiatric industry: The Emperor’s New Drugs: Exploding the Antidepressant Myth, by Irving Kirsch; Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America by Robert Whitaker, and Unhinged: The Trouble with Psychiatry–A Doctor’s Revelations About a Profession in Crisis, by Daniel Carlat. She also cites the DSM-IV, the most recent edition of the manual, while her review traces big pharma’s role in our current mental disorder epidemic to the DSM-III, published in 1980.

To begin, Angell describes the psychiatric profession’s backlash against a developing perception in the 1960s and 1970s that the practice was a “soft” almost pseudo science:

In the late 1970s, the psychiatric profession struck back–hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible.

Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

These efforts to enhance the status of psychiatry were undertaken deliberately. The APA was then working on the third edition of the DSM, which provides diagnostic criteria for all mental disorders. The president of the APA had appointed Robert Spitzer, a much-admired professor of psychiatry at Columbia University, to head the task force overseeing the project. The first two editions, published in 1952 and 1968, reflected the Freudian view of mental illness and were little known outside the profession. Spitzer set out to make the DSM-III something quite different. He promised that it would be “a defense of the medical model as applied to psychiatric problems,” and the president of the APA in 1977, Jack Weinberg, said it would “clarify to anyone who may be in doubt that we regard psychiatry as a specialty of medicine.”

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

Despite its lack of citations, that DSM named 265 disorders doctors were meant to identify by matching (or mostly matching) a list of symptoms in the book with symptoms described by a patient. The drug companies were quick to see this radical shift in psychiatry as an opportunity. From the 1980s until now, as Angell demonstrates, the drug makers have supported the move away from talk therapy to the drug therapy, which also benefits practitioners, since doling out drugs and tweaking prescriptions earns a psychiatrist more money for less time spent with a patient.

Here Angell explains how companies influence the DSM itself. The bold typeface is ours.

Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

The drug industry, of course, supports other specialists and professional societies, too, but Carlat asks, “Why do psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies?” His answer: “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another.” Unlike the conditions treated in most other branches of medicine, there are no objective signs or tests for mental illness—no lab data or MRI findings—and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that.

Eli Lilly gave $551,000 to NAMI

In addition to the money spent on the psychiatric profession directly, drug companies heavily support many related patient advocacy groups and educational organizations. Whitaker writes that in the first quarter of 2009 alone, “Eli Lilly gave $551,000 to NAMI [National Alliance on Mental Illness] and its local chapters, $465,000 to the National Mental Health Association, $130,000 to CHADD (an ADHD [attention deficit/hyperactivity disorder] patient-advocacy group), and $69,250 to the American Foundation for Suicide Prevention.”

And that’s just one company in three months; one can imagine what the yearly total would be from all companies that make psychoactive drugs. These groups ostensibly exist to raise public awareness of psychiatric disorders, but they also have the effect of promoting the use of psychoactive drugs and influencing insurers to cover them. Whitaker summarizes the growth of industry influence after the publication of the DSM-III as follows:

“In short, a powerful quartet of voices came together during the 1980’s eager to inform the public that mental disorders were brain diseases. Pharmaceutical companies provided the financial muscle. The APA and psychiatrists at top medical schools conferred intellectual legitimacy upon the enterprise. The NIMH [National Institute of Mental Health] put the government’s stamp of approval on the story. NAMI provided a moral authority.”

And now here we are in 2011, with almost everyone we know taking two or three different mood disorder drugs. (This trend is not limited to mental disorder, mind you. See Disease Branding.)

Work started on the DSM-V in 1999, which is due out in 2013. It will contain many new disorders, such as “binge eating” and “restless leg disorder.” It will also expand existing categories by tacking on words like “spectrum” to the end of a known disorder, Angell reports. “It looks as though it will be harder and harder to be normal,” she writes.

But the curtain gets pulled back further still.

In her review of Daniel Carlat’s book, Angell calls attention to the “disillusioned insider’s” frank admission that when he prescribes a drug, his decision process is largely guesswork. Carlat’s view is that although any psychiatrist will acknowledge that he or she has had great success with mental disorder drugs for say, depression or anxiety, no doctor can say with certainty whether the drugs are working or if a placebo effect has taken effect.

[Carlat's] work consists of asking patients a series of questions about their symptoms to see whether they match up with any of the disorders in the DSM. This matching exercise, he writes, provides “the illusion that we understand our patients when all we are doing is assigning them labels.” Often patients meet criteria for more than one diagnosis, because there is overlap in symptoms. For example, difficulty concentrating is a criterion for more than one disorder. One of Carlat’s patients ended up with seven separate diagnoses. “We target discrete symptoms with treatments, and other drugs are piled on top to treat side effects.” A typical patient, he says, might be taking Celexa for depression, Ativan for anxiety, Ambien for insomnia, Provigil for fatigue (a side effect of Celexa), and Viagra for impotence (another side effect of Celexa).

As for the medications themselves, Carlat writes that “there are only a handful of umbrella categories of psychotropic drugs,” within which the drugs are not very different from one another. He doesn’t believe there is much basis for choosing among them. “To a remarkable degree, our choice of medications is subjective, even random. Perhaps your psychiatrist is in a Lexapro mood this morning, because he was just visited by an attractive Lexapro drug rep.”

Messy. And, of course, the whole system is now being exported to China and other countries where the middle class is growing and the mental health industry is still in a developing stage.

Angell’s latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

Read the rest of her essay, which examines the controversial use of brain chemistry drugs to treat children, here.

http://www.minyanville.com/dailyfeed/2011/07/25/harvard-expert-links-our-mental/

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