Posts Tagged ‘Bristol-Myers Squibb’

US Department of Justice Probes Corruption in Big Pharma; Glaxo, Pfizer, Bristol-Myers Squibb, Eli Lilly & Merck

Friday, August 13th, 2010

Financial Times
By Stephanie Kirchgaessner
August 12, 2010

The US Department of Justice is scrutinising payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe.

GlaxoSmithKline, Pfizer, Bristol-Myers Squibb and Eli Lilly, among others, have disclosed being contacted by the DoJ and Securities and Exchange Commission in connection with the investigation. Merck, the US drugs group, announced last week that it had also been contacted and was co-operating with investigators.

An industry attorney familiar with the probe said that the DoJ was looking at whether pharma companies had ignored a “systematic risk” inherent in the global drugs business and ignored obligations under local and US anti-bribery law.

The highly regulated nature of the business, combined with the fact that healthcare officials in many non-US markets were government funded, made the industry a natural target for such a probe, the person added.

The investigation is at a relatively early stage but is considered a priority for the DoJ.

While hospitality – including meals and all expenses-paid travel for conferences – has long been considered a potential risk for pharma groups, the DoJ’s probe is looking at all aspects of companies’ dealings in non-US markets, people familiar with the matter say. That includes the recruitment of physicians for clinical trials. In some markets, the same physicians may serve on regulatory boards that approve or deny drugs.

The DoJ declined to comment. But last November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.

Mr Breuer warned a conference of pharmaceutical industry lawyers that prosecutors were gearing up for an investigation of international corruption in the sector. The drugs companies took notice.

That threat has now become a reality. Merck, AstraZeneca, Eli Lilly, Baxter, SciClone, and Bristol-Myers Squibb have in recent months received inquiries from the DoJ and the Securities and Exchange Commission in connection with an industry-wide bribery ­investigation.

GlaxoSmithKline, the UK drugmaker, told the Financial Times on Thursday that it too had received “inquiries” from US authorities, but that it disclosed the issue “reactively” only to selected reporters in April.

Pfizer, the world’s largest pharmaceutical group, said in February that it had voluntarily provided the DoJ and SEC with information concerning potentially improper payments outside the US and was exploring resolution of the matter.

There is perhaps no industry that is as vulnerable to violations of US anti-bribery laws as the pharmaceutical industry. In markets round the world, the companies deal, sometimes thousands of times in a single day, with doctors, clinicians, hospital operators and regulators who are considered under US law to be government officials, because they are employed by state-owned facilities.

Under the Foreign Corrupt Practices Act, the US anti-bribery law, companies may not offer items of value to foreign government officials for profit. One industry lawyer involved in the matter said global pharmaceutical companies operating in countries with state-run medical institutions deal with government officials at every turn of their business: whether it is seeking the go-ahead for a manufacturing site; obtaining drug licences; conducting clinical trials; importing drugs; selling and marketing drugs to physicians; or getting a product on to a hospital’s approved list.

“What most companies will find is that all of these areas are risky and, if they don’t train and educate their people, they are going to find themselves with issues. For example, if you have hired customs brokers, how do you know they aren’t bribing officials?” the attorney said.

According to the law firm Arnold & Porter, the DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.

A person familiar with the investigation confirmed that clinical trials were one of several areas the DoJ was examining.

Alexandra Wrage, the president of Trace, a non-profit organisation that helps companies establish anti-corruption practices, said that alleged wrong­doing at pharmaceutical companies could often centre on inappropriately lavish hospitality, such as wining and dining doctors from state-run hospitals at conferences in Bali or Monaco.

Read entire article here:  http://www.ft.com/cms/s/0/9a8e8f90-a63e-11df-8767-00144feabdc0.html
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Meet the Psychiatrist Pushing For A Brave New World of Pre-Drugging Kids—Patrick McGorry

Friday, May 21st, 2010

By CCHR International
May 21, 2010

One of the most controversial proposed disorders for the upcoming revision of psychiatry’s billing bible of mental disorders, (the DSM-5) is Psychosis Risk Syndrome (PRS) a “mental disorder” that, if voted into DSM, would confirm the allegations that psychiatry is manufacturing a Brave New World for itself—heavily backed by Big Pharma—of drugging children before they develop a “mental illness.” Already criticized for the millions of children being needlessly drugged and the lack of scientific criteria to substantiate any mental diagnosis as a legitimate medical condition, some psychiatrists now want the power to pull out their crystal ball and predict the onset of a psychosis and drug it before it has even occurred. And perhaps the strongest proponent is Australian psychiatrist Patrick McGorry.

Even psychiatrist Allen Frances, former chairman of the previous DSM task force expressed alarm over the proposed diagnosis and its repercussions should it be legitimized, stating, PRS “stands out as the most ill-conceived and potentially harmful.” The Syndrome fails badly on all 3 counts, he says:

“1. It would misidentify many teenagers who are not really at risk for psychosis;

2. The treatment they would most often receive (atypical antipsychotic medication) has no proven efficacy; but,

3. It does have definite dangerous complications.”

Frances adds: “Drug company marketing would influence parents and clinicians to be especially alert to any strangeness in teenagers.” False positives could be as high as 70-90 percent.[i] This can only lead to greater numbers of children and adolescents being harmfully drugged—already one of the major criticisms against psychiatry and a point of contention among many psychiatrists today.

Australian psychiatrist Patrick McGorry, speaking at the APA convention in New Orleans, as a cheerleader for “early intervention” (i.e. pre-drugging) is undeterred. Despite the unpredictability and risk of the drugs prescribed to treat PRS, McGorry wants to go full steam ahead, increasing the number of children being placed on extremely dangerous and even lethal drugs. It should come as no surprise that McGorry is a paid consultant for, and has received speaker’s fees from AstraZenecca, Janssen-Cilag, Eli Lilly, Novartis, Sanofi, Bristol Myers Squibb and Pfizer.[ii]

The theory of PRS wasn’t McGorry’s. He credits Dr. Ewen Cameron, the Canadian psychiatrist who became infamous in the 1980s after it was revealed he had performed cruel and brain-damaging experiments on his patients in the 1950s and 1960s with funding from the CIA.[iii] However, McGorry tested it in a world-first trial. Another study he conducted in 2002 was funded with an unrestricted grant from Janssen-Cilag and supported by pharmaceutical company-funded groups NARSAD and the Stanley Foundation, as well as several Australian agencies. McGorry and colleagues predictably found that risperidone (Risperdal)—made by Janssen—reduced the risk of “transition to psychosis” in young people.[iv] Risperdal has been linked to Type 2 diabetes.

  • In Australia, McGorry’s Early Psychosis Prevention and Intervention Center’s (EPPIC) preventive treatment center for young people, PACE, receives drug company funding from Janssen-Cilag. Much of the policy development embodied in the Australian Clinical Guidelines has come out of EPPIC research programs. As Richard Gosden, Ph.D., a highly respected Australian author and academic stated: “This may have paid off handsomely for the company…. It may not be coincidental that a half page of the Clinical Guidelines is dedicated to dosage recommendations for using risperidone in first-episode psychosis. The Clinical Guidelines do not extend these dosage recommendations to include other schizophrenia drugs and the recommendations for risperidone give the appearance of an official endorsement of the drug.” [v]

McGorry’s theory has psychiatry’s skeptics and even psychiatrists aghast:

  • One respected American research group equated the practice of pre-drugging children to “performing mastectomies on women who are at risk of—but do not have—breast cancer.” [vi]
  • Honorary Professor Anthony Pelosi from the Department of Psychiatry, Hairmyres Hospital, East Kilbride, stated, “So far, evidence from randomized trials does not support the use of psychological therapies or drugs as preventive interventions.”[vii] Further, “After teachers, college counselors, and families were encouraged to refer young people with possibly prodromal [early] symptoms directly to the same clinic for the same care plans…almost 90% were receiving unnecessary ‘preventive’ interventions.” [viii]
  • Fellow Australian psychiatrist Niall McLaren says the diagnostic criteria for PRS “has no scientific validity whatsoever…it can never be reliable and…will have huge unforeseen consequences.” Essentially, it means “putting large numbers of teenagers and young adults under the long-term supervision and control of psychiatrists” and that “supervision” includes the “aggressive, indefinite prescription of antipsychotic drugs.” It is the “clearest example I know of pseudoscience.  Not since [lobotomies] has psychiatry stumbled so far from the principle of Primum, non nocere. First, do no harm.” [ix]
  • Dr. Richard Warner, professor of psychiatry at the University of Colorado, counters the idea that science drives McGorry’s pre-disorder assessment, stating that the screening instrument he uses “is not that accurate in routine use.” Further, “McGorry speculates that a variety of interventions may be effective in preventing schizophrenia in high-risk cases…. Given the expected number of false positives, the potential for harm is significant,” stated Dr. Warner. [x]
  • Dr. Jerald Block, a US psychiatrist writing in Bioethics Forum, reported that “preventive pharmacology” (which McGorry, et al. practice) is “ethically questionable territory” because the treatments given “frequently have side effects and complications” and “you are potentially harming people.” The symptoms used to identify them as at risk of schizophrenia are “also remarkably common…adolescence is a period of life that is normally marked by tumultuous changes in personality.” [xi]
  • Melissa Raven, psychiatric epidemiologist and policy analyst, adjunct lecturer in Public Health at Flinders University, South Australia, and David Webb, board member of the World Network of Users and Survivors of Psychiatry and working with the research/policy office with the Australia Federation of Disability Organizations, were published last month, writing: “McGorry’s campaign is part of a wider push to promote the medicalization of mental health (for which psychosocial wellbeing is a better term).” “Further doubts must be raised about McGorry’s agenda when you see the substantial funding his organization (Orygen Youth Health) receives from the pharmaceutical industry and also from the US Stanley Foundation, which is notorious for its particularly aggressive approach to the detention and mandatory treatment of people labeled with psychiatric disorders.” He has “personally received funding from many manufacturers of antipsychotics, frequently reports no conflicts of interest, particularly in his many recent Medical Journal of Australia articles, including a supplement on early intervention that repeatedly advocates the use of antipsychotics.” [xii]

Psychosis Risk Syndrome is nothing more than psychiatrists with conflicts of interest drumming up more business at the risk of teenage lives, while increasing the profits for the pharmaceutical industry they serve.


[i] Allen Frances, M.D., “DSM5 ‘Psychosis Risk Syndrome’–Far Too Risky,” Psychology Today, http://www.psychologytoday.com/blog/dsm5-in-distress/201003/dsm5-psychosis-risk-syndrome-far-too-risky.

[ii] http://www.mhanet.ca/documents/2008/Research-Colloquium/0920%20-%20Keynote%20MCGORRY.pdf; http://www.bmj.com/cgi/content/full/337/aug04_1/a695.

[iii] Richard Gosden, Ph.D., “Pre-Psychotic Treatment for Schizophrenia: Preventive Medicine, Social Control, or Drug Marketing Strategy?” Ethical Human Sciences and Services, Vol 1, No. 2, Summer 1999, pp. 165-177, http://sites.google.com/site/richardgosden/ehss.

[iv] Arch Gen Psychiatry, Vol 59, Oct. 2002, http://www.meb.uni-bonn.de/psychiatrie/zebb/literatur/mcgorry.pdf.

[v] Richard Gosden, Ph.D., “Pre-Psychotic Treatment for Schizophrenia: Preventive Medicine, Social Control, or Drug Marketing Strategy?” Ethical Human Sciences and Services, Vol 1, No. 2, Summer 1999, pp. 165-177, http://sites.google.com/site/richardgosden/ehss.

[vi] http://www.ministryoflies.com/pdf-articles/Yale-Lilly.pdf.

[vii] Anthony Pelosi, “Head to Head, Is early intervention in the major psychiatric disorders justified? No,” BMJ 2008;337:a710, http://www.bmj.com/cgi/content/full/337/aug04_1/a710.

[viii] http://www.bmj.com/cgi/content/full/337/aug04_1/a710.

[ix] Niall McLaren, M.D., “Psychosis Risk Syndrome (PRS),” 14 May 2010 (soon to be published).

[x] Richard Warner, MB, DPM, is director of Colorado Recovery in Boulder, Colorado, and professor of psychiatry at the University of Colorado, “Early intervention in psychosis: Future or fad?” Centre for Addiction and Mental Health website, http://www.camh.net/Publications/Cross_Currents/Winter_2007-08/futureorfad_crcuwinter0708.html.

[xi] http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=386; http://ww.bioethicsforum.org/ethics-of-preventive-psychopharmacologic-treatments.asp.

[xii] David Webb, Melissa Raven, “McGorry’s ‘early intervention’ in mental health: a prescription for disaster,” Online Opinion, http://www.onlineopinion.com.au/view.asp?article=10267.

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Its about time…With drug companies paying criminal fines of $7 billion, FDA to increase prosecution of Pharma Execs

Tuesday, March 9th, 2010

Pharmalot
By Ed Silverman
March 4, 2010

The FDA plans to increase misdemeanor prosecutions of industry execs as it looks to refocus its Office of Criminal Investigations (see this letter to the Senate Finance committee). The move comes in response to a new report from the General Accountability Office that the OCI suffers from lax oversight, despite increased in funding and staffing over the past decade. In fact, the FDA hasn’t reviewed most OCI offices in more than three years. The OCI investigates counterfeit drugs and other bad stuff, as well as misconduct by FDA employees.

The GAO concluded the FDA “has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.” The GAO found assessments of six OCI field offices aren’t being done on a timely basis. Of 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office hadn’t been assessed in over 10 years.

In addition, the FDA lacks performance measures that could enhance oversight by allowing it to assess OCI’s overall success. A few more facts: the OCI has a 230-person operation with more than $41 million in funding. In 2008, the group’s investigations led to more than 400 convictions. The OCI budget rose 73 percent between 1999 and 2008 to $41 million, and the number of employees increased by about 40 percent.

The GAO study, which was first reported by The Wall Street Journal, was requested by Chuck Grassley, the ranking Republican on the US Senate Finance, who has been probing drug safety issues, among other things. A report on GlaxoSmithKline’s Avandia noted that several drugmakers – Pfizer, Lilly, Bristol-Myers Squibb – have recently paid large criminal fines totaling $7 billion. Among the infractions – off-label promotion.

Read entire article:  http://www.pharmalot.com/2010/03/fda-oversight-of-criminal-investigations-is-lax/

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US Kids Represent Psychiatric Drug Goldmine

Monday, December 14th, 2009

Truthout
Evelyn Pringle
December 12, 2009

Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.

On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.

In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.

The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as “mood stablizers” and the arrival of the new atypical antipsychotics.

Read entire article: http://www.truthout.org/1213091

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