Showing posts with label Illegal Marketing. Show all posts
Showing posts with label Illegal Marketing. Show all posts
Oct 4, 2012
Who is the idiot that put the active participants in an ongoing criminal enterprise in charge of protecting the victims?
I am biased. My son is a Risperdal victim. J&J started illegally marketing the drug as soon as it was FDA approved. All due respect to the Justice Department, the investigation going back to 2004, is not going back far enough. J&J had been illegally marketing Risperdal for close to a decade by 2004. The DOJ fines and penalties are very small % of the money that J&J defrauded from the American people through Medicaid and Medicare, and have not caused J&J to alter the unethical manner in which business is conducted. More importantly, these fines and penalties do not help J&J's PRIMARY VICTIMS who are grievously harmed. There is no way to compensate those who mourn the loss of a family member, the parents and children of J&J's victims who were killed by iatrogenic homicide. How can it ever rectify the harm done to Risperdal victims who were further victimized because the adverse effects of Risperdal were attributed to the patient's "psychiatric disease," or attributed to yet another psychiatric disease, which required adding a comorbid diagnosis? It does nothing for the parents who are taking care of an adult child that is disabled like my son is? My son requires a great deal of assistance, and probably will for the rest of his life. Don't misunderstand me, it is an honor and a priveledge to take care of my son; but, it is also a tragic that it is even necessary.
a screen shot from Sheller FDA Petition Comments
I am getting real tired of the "news reports" in the mainstream media which are about risk for diabetes and obesity from the neuroleptic drugs, called "antipsychotics." Children are being prescribed neuroleptic drugs for virtually any and every diagnosis---this is clearly Human Experimentation, occurring in Standard Clinical Practice; referring to it as "off label prescribing" implies that that there is some statistically relevant evidence which supports using these teratogenic drugs with fatal risks in the manner they are being used. The evidence does not even support using the drugs for the diagnosis of schizophrenia as a "first-line treatment," the condition for which the drugs were originally developed and prescribed for.
The very real risks of obesity and diabetes however are not, at least in my mind, what is most alarming about the fact that so many children are being prescribed neuroleptic drugs; nor is the fact that the American people are being defrauded through Medicaid (still!) in order to pay for these "off label" prescriptions over 90% of the time. Nor is it that journalists are failing to ethically report on any of the issues involved with prescription drugs, with rare exception. The articles are often lost amongst the prescription drug advertising and the press releases journalists publish without verifying the veracity of any of the "facts" which the press releases contain...I accept that this is what is passes for "reporting the news." There is very little reporting in the mainstream news about the rampant fraud in academic research, there is even less about the questionable (to say the very least) FDA approval process; this keeps people misinformed, dangerous drugs stay on the market, and keeps people are unaware of the risks involved when seeking psychiatric treatment. Once drugs are FDA approved, the manufacturers rarely do the required after-market testing, and are never held accoutable for this failure. There is little effort to no effort invested in regulating the marketing of FDA approved drugs so there are no meaningful consequences for making false claims in direct-to-consumer and direct-to-professional marketing of FDA approved drugs. Apparently, the fact that people are being harmed at an alarming rate, is not "news," it is rarely reported. All of this is due to the unethical conduct of public servants with glaring conflicts of interest, which is also rarely if ever, reported by mainstream journalists.
Add to this obfuscation of the facts regarding psychiatric diagnoses and the toxic teratogens used to "treat" them, is the fact that adverse effects (including death) do not have to be reported to the FDA by medical professionals--If the FDA's primary purpose is to protect people from the risks of prescription drugs, adverse events and adverse effects is data that should be required reporting, it is needed order to effectively assess a drug's safety profile. The FDA's primary purpose is not to protect the American people from the risks for harm, if it were, prescribers would be required to report adverse effects and adverse events. Protecting patients from harm is only a stated purpose; it is a marketing tool, a cover story. I don't believe protecting the American people was ever the FDA's primary purpose; it certainly is not a purpose that is effectively or ethically served currently.
The primary purpose served by the modern FDA is to protect the interests of the pharmaceutical industry. People who are given a psychiatric diagnosis are automatically at risk for experiencing grave harm because diagnostic criteria and treatment standards are developed by consensus; and consensus is regularly substituted for empirical data. There are two reasons for this, the first reason is there is insufficient evidence, and the second reason is the evidence does not support the marketing agenda in which it is claimed drugs sagfely and effectively treat a diagnosis. Psychiatry in this way ignores ethical scientific research standards; and it is abdicates it's responsibility for exercising sound, ethical medical judgement. It is a systematic way to standardize Human Experimentation on people who are given a psychiatric diagnosis in standard practice. The unethically developed "Standards of Care" become an affirmative defense for unethical medical practice, they are in this used by professionasl to abdicate any and all liability for harm to patients. Calling it a Standard of Care when it ignores ethical, scientific research and ethical medical practice standards is such utter BS---no one can possibly believe deception, fraud, and unethical behavior are necessary to provide mental health care. It is a way to rationalize, justify and codify unethical behavior; it serves to absolve doctors of liability for the grievous harm inflicted on patients using dangerous drug saccording to unethical standards.
In standard clinical mental health practice, there is no empirical data that is used to objectively diagnose a person. More often than not, there is no evidence that would support the recommended treatment. The treatment is usually teratogenic drugs with fatal risks, and/or electroshock. The reality is there is very little science and a whole lot of consensus. Consensus is evidence of agreement; it is not evidence of diagnostic validity; it is not an ethical basis for a medical treatment, much less a basis to force a person, since it does have the serious risks of causing disability and death! Patients are at a serious disadvantage, as soon as a psychiatric diagnosis is attached. Rarely is the harm done to them reported. In my experience, as the mother of a child who was the victim of a violent assault, once a psychiatric diagnosis was attached, the harm done to my son, including felony crimes committed by "professionals," can be reported; but are never investigated.
Adverse reactions from drugs, (if even recognized as an adverse reaction) are attributed to the psychiatric "disease" the patient is diagnosed with. The way the mental health psychiatric system is set up, the direct adverse effect of diagnosis and treatment upon the patient is not relevant; negative effects are rarely acknowledged, if at all. These effects are purposely not being collected; consequently the harm cannot be quantified by those with an ethical duty to do so. Indeed, the people who have an ethical and a legal duty to, "First, do no harm..." are covering up the evidence that they are doing a great deal of harm to a great number of victims whom they call patients. The majority of these victims are poor children and foster children on Medicaid, the elderly on Medicare, and traumatized Veterans on Tri-Care. They all have one thing in common: they were seen as a means to an end. Their psychiatric stigmatization was the means and meeting the marketing goals of the pharmaceutical industry was the financially lucrative ends. these particular populations were targeted for diagnosis and treatment because they had medical benefits which would pay the costs of their "care." They were used because the American people had seen fit to ensure these vulnerable people had their medical needs provided for. Pharma's illegal marketing campaigns targeted those among us who are the most vulnerable, and least capable of effectively defending themselves to meet their marketing goals...Isn't that special?
Back to my original point, the things that are NOT being discussed are the serious adverse effects on sexual functioning that Risperdal and other psychotropic drugs have on human beings. We are allowing children who are not sexually mature, to be given drugs which adversely effect normal sexual development and functioning; in effect, ensuring that many will never be capable of having a normal sexual relationship. If that is not a risk which should be of concern to their parents and the professionals who are alarmed about the diabetes and obesity risk, than I am Mary freaking Poppins! The rate children are being disabled and killed is not even MENTIONED by any of the "stake-holders" involved in the frantic efforts undertaken (supposedly on the behalf of foster children) when the THIRD Senate investigation was launched into the off label prescribing of teratogenic drugs to vulnerable children. The very people who we entrust to take care of our Nation's foster children do not appear to be concerned at all about how many of the children have been disabled and killed due to the direct negative effects of off label prescriptions taken as directed. These are relevant facts which should be part of the discussion; however, they are in fact being ignored by the paid public servants in Child Welfare, Academic Researchers paid to do drug and psychiatric treatment research, grassroots advocates claiming to be the Nation's voice on mental illness, The American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.
Well I am WIDE awake and I want to know why are the worst risks faced by these children for brain damage, sexual development, and sexual dysfunction, sudden death, and chronic neurological impairment are being ignored by those who are "concerned." The study below is over; as usual, results are not available...
But more than this, I want to know who is the idiot who thought putting active participants in an ongoing criminal enterprise, in charge of protecting their victims was a good idea?
Clinical Trials.gov
An Observational Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
This study has been completed.
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01050582
First received: January 14, 2010
Last updated: May 25, 2012
Last verified: May 2012
Purpose
The purpose of this observational study is to evaluate risk of prolactin-related adverse events (side effects) and the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children exposed to these drugs
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia Bipolar Disorder Autistic Disorder Attention Deficit and Disruptive Behavior Disorders | Drug: Risperidone Drug: Other atypical antipsychotic drugs | Phase 4 |
| Study Type: | Interventional |
| Official Title: | Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs |
Resource links provided by NLM:
MedlinePlus related topics: Autism Bipolar Disorder Schizophrenia
Drug Information available for: Prolactin Risperidone
U.S. FDA Resources
Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
- To compare Z-scores for height, age at current Tanner stage, and prolactin-related adverse events between patients exposed to risperidone and patients exposed to other atypical antipsychotic drugs. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess the prolactin value and risk of hyperprolactinemia associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population. [ Time Frame: One time during the study visit ] [ Designated as safety issue: Yes ]
- Identification of subgroups of patients at high risk for changes in height or maturation. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: No ]
| Enrollment: | 244 |
| Study Start Date: | October 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: 001
Risperidone As per local prescribing practices
| Drug: Risperidone
As per local prescribing practices
|
| No Intervention: 002
Other atypical antipsychotic drugs As per local prescribing practices
| Drug: Other atypical antipsychotic drugs
As per local prescribing practices
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 8 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- One or both parents (according to local regulations) or a guardian must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study (If appropriate according to local regulations, the patient must also assent)
- Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders
- Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit (patients may or may not be taking the atypical antipsychotics at the time of actual enrollment, eligible patients can have exposure to multiple atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1 atypical antipsychotic for a period of greater than 30 days)
- Had medical records or automated data available for at least 1 year prior to the start of exposure
- Height and weight were recorded at least once within 1 year before the start of exposure, and if available at any time points after the start of exposure in the medical records or electronic databases (not mandatory)
Exclusion Criteria:
- Have at least 1 medical record, at any time before the start of exposure, consistent with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental delay or abnormality associated with growth or sexual maturation delays not related to the specified indications
- Had exposure to prolactin elevating medications other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs)
- Had exposure to Paliperidone
- Cannot comply with study procedures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050582
Hide Study Locations
Hide Study Locations
Locations
| United States, California | |
| San Francisco, California, United States | |
| United States, Colorado | |
| Aurora, Colorado, United States | |
| United States, Florida | |
| Altamonte Springs, Florida, United States | |
| Gainesville, Florida, United States | |
| United States, Georgia | |
| Smyrna, Georgia, United States | |
| United States, Illinois | |
| Naperville, Illinois, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| Valparaiso, Indiana, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| Cambridge, Massachusetts, United States | |
| United States, New York | |
| Glen Oaks, New York, United States | |
| United States, Ohio | |
| Cleveland, Ohio, United States | |
| Columbus, Ohio, United States | |
| Belgium | |
| Antwerpen, Belgium | |
| Germany | |
| Freiburg, Germany | |
| Jena, Germany | |
| Mannheim, Germany | |
| München, Germany | |
| Tübingen, Germany | |
| Ulm, Germany | |
| Würzburg, Germany | |
| Greece | |
| Athens, Greece | |
| Netherlands | |
| Nijmegen, Netherlands | |
| Poland | |
| Gdansk, Poland | |
| Kielce, Poland | |
| Lódź, Poland | |
| Sosnowiec, Poland | |
| Warszawa, Poland | |
| Warszawa N/A, Poland | |
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More InformationNo publications provided
| Responsible Party: | Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01050582 History of Changes |
| Other Study ID Numbers: | CR016687 |
| Study First Received: | January 14, 2010 |
| Last Updated: | May 25, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
| Schizophrenia Bipolar Disorder Autistic Disorder Attention Deficit and Disruptive Behavior Disorders Risperidone | RISPERDAL Antipsychotic Agents Prolactin Pediatrics |
Additional relevant MeSH terms:
| Schizophrenia Child Development Disorders, Pervasive Schizophrenia and Disorders with Psychotic Features Autistic Disorder Mental Disorders Bipolar Disorder Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder with Hyperactivity Mental Disorders Diagnosed in Childhood Affective Disorders, Psychotic Mood Disorders Antipsychotic Agents Risperidone | Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on October 03, 2012
Jul 10, 2012
A question about the GSK settlement
I'm not impressed with the recent $3 billion dollars in fines and penalties the Department of Justice settled for in litigation against GlaxoSmithKline; it is a paltry sum when one considers how much these robber barons pinched from out of our collective pockets... The amount pales even further when one adds the the human toll paid for GSK's corporate malfeasance. While this settlement is the largest one to date; it is but a drop in the bucket. Lets be clear: The drugs GSK illegally marketed, were unethically prescribed by physicians who bought into GSK's marketing hype, and who convinced other medical professionals to do the same---to their patient's detriment.
One of the reasons this criminal enterprise was so successful, is because the FDA rolled over and played dead once the drugs were FDA approved. The FDA has failed to regulate the direct to consumer and direct to professional marketing of any of the FDA approved drugs involved in Federal litigation. I see no victory in the DOJ later retrieving a small percentage of what was stolen from patients by these modern day robber barons. Do not forget, much of this money was in effect, willingly handed over to these robbers barons on a silver platter through fraudulent claims paid by Medicaid and Medicare. Claims that should not have been paid; magically were. Fraudulent claims still are being paid for the off-label prescription of psychiatric drugs to children on Medicaid in case anyone cares...
It is true that we have been robbed, but every single Federal program failed in it's duty to the American people---which gives the appearance these programs are serving the interests of industry; not the interests of patients...
The FDA failed to regulate the direct to professional marketing of the drugs. As a result, physicians wrote prescriptions that should not have been written.
In 2010, Advair sales amounted to $7.8 billion in revenue for GSK; so $3 billion is a very small drop in a very large bucket...By the way, that $7.8 billion, "fell slightly short of analysts' projections." Don't your heart just bleed a little for GSK reading that?
via: 
Pharma
Big Ten Branded Drug Blockbusters of 2010
World’s Top Selling Branded Pharmaceuticals4. Advair Diskus
Sales: $7.8 billion Generic name: fluticasone; salmetrol Advair Diskus is prescribed for the management of asthma and chronic obstructive pulmonary disease COPD) symptoms.
Sales of GlaxxoSmithKline's Advair fell slightly short of analysts' projections, partly due to loss of patent protection in several European countries.
NONE of this could have been accomplished
without the participation of Doctors...
via
GlaxoSmithKline found guilty while complicit physicians remain unscathed
Although there has, rightly, been much criticism of GlaxoSmithKline’s illegal behaviour and activities, the physicians who allowed themselves to be used by the company are complicit in these crimes. Such self-serving behaviour does not put patients first and is an indictment on the entire medical profession.
Should complicit physicians remain unscathed?
(emphasis mine) read here
GlaxoSmithKline found guilty while complicit physicians remain unscathed
Although there has, rightly, been much criticism of GlaxoSmithKline’s illegal behaviour and activities, the physicians who allowed themselves to be used by the company are complicit in these crimes. Such self-serving behaviour does not put patients first and is an indictment on the entire medical profession.Should complicit physicians remain unscathed?
(emphasis mine) read here
For more on Andrew Witty, the CEO of GSK, read Bobby Fiddaman's blog:
GlaxoSmithKline: The Andrew Witty Era Jun 5, 2012
Medicaid fraud and the failure of medical professionals
"Primum non nocere"
"Declare the past, diagnose the present, foretell the future; practice these acts.
As to diseases, make a habit of two things--to help, or at least to do no harm."
Hippocrates
A 2006 article in The Oxford Medical Journal QJM, which is excerpted below, Dr. B.G. Charlton asks the question, Why are doctors still prescribing neuroleptics?
"The Parkinsonian (emotion-blunting and de-motivating) core effect of neuroleptics has been missed by most observers. This failure relates to a blind-spot concerning the nature of Parkinsonism.
"Parkinsonism is not just a motor disorder. Although abnormal movements (and an inability to move) are its most obvious feature, Parkinsonism is also a profoundly ‘psychiatric’ illness in the sense that emotional blunting and consequent demotivation are major subjective aspects. All this is exquisitely described in Oliver Sack's famous book Awakenings, 10 as well as being clinically apparent to the empathic observer.
"Emotional blunting is demotivating because drive comes from the ability subjectively to experience in the here-and-now the anticipated pleasure deriving from cognitively-modelled future accomplishments.2 An emotionally-blunted individual therefore lacks current emotional rewards for planned future activity, including future social interactions, hence ‘cannot be bothered’.
"Demotivation is therefore simply the undesired other side of the coin from the desired therapeutic effect of neuroleptics. Neuroleptic ‘tranquillization’ is precisely this state of indifference.8 The ‘therapeutic’ effect of neuroleptics derives from indifference towards negative stimuli, such as fear-inducing mental contents (such as delusions or hallucinations); while anhedonia and lack of drive are predictable consequences of exactly this same state of indifference in relation to the positive things of life.
"So, Parkinsonism is not a ‘side-effect’ of neuroleptics, neither is it avoidable. Instead, Parkinsonism is the core therapeutic effect of neuroleptics: as reflected in the name, which refers to an agent which ‘seizes’ the nervous system and holds it constant (i.e. indifferent, blunted).4 Demotivation should be regarded as inextricable from the neuroleptic form of tranquillization.2 And the so-called ‘negative symptoms’ of schizophrenia are (in most instances) simply an inevitable consequence of neuroleptic treatment.4 " here
Washington state's medicaid program began monitoring prescriptions of narcotics, antidepressants and other psychotropic drugs to prevent excessive or inappropriate prescriptions and to funnel clients addicted to prescription drugs into treatment, in June of 2005. here
Washington State developed the Partnership Access Line, 'PAL' which is a consultation service that professionals can call for prescription advice, also developed were the Primary Care Principles for Child Mental Health which can be accessed online or can be downloaded as a pdf. The section Non-Specific Medications for Disruptive Behavior and Aggression of this document recommends neuroleptic drugs, specifically, Risperidone (Risperdal) Aripiprazole (Abilify) Quetiapine (Seroquel) Ziprasidone (Geodon) and Olanzapine (Zyprexa) stating, that, "If used, choosing a single medication is strongly recommended over polypharmacy. Establish a specific target to treat, and measure the response over time (such as anger explosion frequency, duration) Aggression is not a diagnosis—continue to look for and treat what may be the cause, usually prescribing psychotherapy." It then lists other drugs Lithium, Valproate, Carbamazepine, Clonidine, and Guanfacine. After these recommendations, it states, None of the medications on this page are FDA approved for aggression treatment, with the exception of risperidone (Risperdal) which is approved for irritability/aggression treatment in autism. (emphasis mine) What this means is there is little to no evidence that quantifies safety, efficacy or effectiveness of the drug recommendations; they are based on consensus not medical science. These drugs have serious, debilitating adverse effects. The Practice Parameters for treating schizophrenia in children and adolescents written by Jon McClellan, estimate that 50% of children treated with neuroleptic drugs will develop an iatrogenic, or physician caused, neurological impairment called Tardive Dyskinesia, which is a mostly irreversible neurological disorder of involuntary movements which can be disabling.
It is very troubling that prescriptions for neuroleptics, which are teratogenic neurotoxins, are being recommended so casually for undesirable and maladaptive coping behaviors; particularly since it is also being acknowledged that the behaviors result from environmental conditions. The behaviors are not symptoms of an underlying medical illness or disease. The negative effects from the drugs in the short term are not clearly or completely understood or described in the resources developed to guide professionals; and even less appropriate information is shared with parents or guardians to base an Informed Consent to treatment. What is known is that the drugs have a serious and deleterious impact on multiple physiological processes including cognition; and it is also known that children experience adverse effects more often and more profoundly than adults who take these drugs.
According to a report on Morbidity and Mortality in People with Serious Mental Illness from the National Association of State Mental Health Program Directors (NASMHPD) Medical Directors Council, "It has been known for several years that persons with serious mental illness die younger than the general population. However, recent evidence reveals that the rate of serious morbidity (illness) and mortality (death) in this population has accelerated. In fact, persons with serious mental illness (SMI) are now dying 25 years earlier than the general population." These facts suggest it is not advisable or even ethical to prescribe these drugs 'off-label' to children; or to anyone else. The fact that it is fraud to submit claims for reimbursement for the costs of off-label prescriptions which are not supported by the Drug Compendia used by CMS for authorizing payment of prescription drugs is apparently not considered an issue. It is fraud for the prescriber and the pharmacist who causes such a claim to be filed; and this is obviously not a deterrent.
The reasons for the increased mortality are mainly attributable to the negative effects of the drugs and the iatrogenic illnesses they cause. These illnesses are then medically neglected by the medical providers who cause them.
In a training lecture on psychiatric drugs, Grace Jackson, M.D. reported,
"The Journal of the American Medical Association (aka, JAMA) featured an article by Johns Hopkins University professor, Dr. Barbara Starfield. The article expanded upon the Institute of Medicine’s theme of iatrogenic (treatment-related) death.
"Using data culled from a variety of inpatient and outpatient investigations, Starfield’s analysis estimated that adverse effects of medication (i.e., “therapeutic” doses of prescription drugs taken exactly as prescribed) account for approximately 305,000 deaths per year.
106,000 inpatient deaths due to pharmaceuticals
199,000 outpatient deaths due to pharmaceuticals
"[Note: Given the fact that “adverse drug reactions” are rarely reported, and given
the fact that drug-related heart attacks, strokes, pneumonias, and cancers are
seldom attributed by physicians or governmental agencies to pharmaceuticals,
these estimates were absurdly conservative.]" Grace Jackson, M.D. here
Jim Gottstein, the founder of PsychRights, has been a fierce advocate for children who are being harmed by psychotropic drugs and psychiatric diagnoses. He has worked to to stop children from being harmed and to stop the massive amount of Medicaid fraud being committed defrauding the American people. This fraud continues unabated despite multiple convictions against the drug makers and massive fines being levied. It is apparent that the pharmaceutical industry considers these fines and the convictions an inconsequential nuisance; it is abundantly clear the fines and convictions have not served as a deterrent to illegal and corrupt business practices. Jim has written a well thought out and practical solution which needs to be given serious consideration for the sake of the Nation's children.
The narcotic pain killers were have been illegally marketed and over prescribed to the detriment of patients, and like the neuroleptics, narcotics have caused iatrogenic diseases and death.
"Washington’s death rate is significantly higher than the national average, it said. In the state’s Medicaid programs, between 2004 and 2007, 1,668 patients died as a result of overdoses, about two-thirds involving methadone.
“These findings highlight the prominence of methadone in prescription opioid-related deaths, and indicate that the Medicaid population is at high risk,” the article said. “Efforts to minimize this risk should focus on assessing the patterns of opioid prescribing to Medicaid enrollees and intervening with Medicaid enrollees who appear to be misusing these drugs.” here
via The Yakima Herald and The Seattle Times
'Elephant in the room'
In December 2010, Dr. Michael Schiesser, a pain specialist in Bellevue, wrote a letter to the P&T committee, retracing the state's history with methadone and crying foul.
When it comes to methadone, Schiesser is the closest thing the state has to a whistle-blower. Three years ago he joined a Health Department work group on accidental poisonings. After that he became involved in legislative deliberations about pain management.
He reviewed transcripts of P&T committee meetings and swept up reports about methadone. The more research he did, the more troubled he became.
Schiesser uses the word "creep" to describe methadone's grip on Washington. As more years passed with the P&T committee saying the drug was as safe as any other, the harder it became for the state to reverse course or hedge by issuing special alerts to physicians of potential complications with methadone.
"So you start to ignore the elephant in the room, which is the mounting evidence," Schiesser says.
His letter challenged a 2008 report that Oregon Health & Science University provided to the committee, saying it "contains errors, deficient logic, and relevant omissions."
The report said one study "found no differences" between methadone and other drugs for overdose risk, when, in fact, the opposite was true, Schiesser wrote. The report mentioned a "black-box warning" from the FDA about OxyContin but not one from the same agency about methadone, he wrote.
In a written reply, an OHSU doctor downplayed Schiesser's points, saying, for example, that FDA black-box warnings are "not evidence."
To Schiesser, such hyper-selectivity has allowed the state to keep saying there's no evidence of methadone being especially risky -- and to the state, no news is good news. He describes the result as: "Because we don't know, therefore it ain't so."
In Washington, medications can go on and off the Preferred Drug List as more evidence develops. The P&T committee meets later this month, when its members will evaluate -- once again -- the safety of methadone.
* Database reporter Justin Mayo and news researchers David Turim and Gene Balk contributed to this report.
* Michael J. Berens: 206-464-2288 or mberens@seattletimes.com; Ken Armstrong: 206-464-3730 or karmstrong@seattletimes.com here
In December 2010, Dr. Michael Schiesser, a pain specialist in Bellevue, wrote a letter to the P&T committee, retracing the state's history with methadone and crying foul.
When it comes to methadone, Schiesser is the closest thing the state has to a whistle-blower. Three years ago he joined a Health Department work group on accidental poisonings. After that he became involved in legislative deliberations about pain management.
He reviewed transcripts of P&T committee meetings and swept up reports about methadone. The more research he did, the more troubled he became.
Schiesser uses the word "creep" to describe methadone's grip on Washington. As more years passed with the P&T committee saying the drug was as safe as any other, the harder it became for the state to reverse course or hedge by issuing special alerts to physicians of potential complications with methadone.
"So you start to ignore the elephant in the room, which is the mounting evidence," Schiesser says.
His letter challenged a 2008 report that Oregon Health & Science University provided to the committee, saying it "contains errors, deficient logic, and relevant omissions."
The report said one study "found no differences" between methadone and other drugs for overdose risk, when, in fact, the opposite was true, Schiesser wrote. The report mentioned a "black-box warning" from the FDA about OxyContin but not one from the same agency about methadone, he wrote.
In a written reply, an OHSU doctor downplayed Schiesser's points, saying, for example, that FDA black-box warnings are "not evidence."
To Schiesser, such hyper-selectivity has allowed the state to keep saying there's no evidence of methadone being especially risky -- and to the state, no news is good news. He describes the result as: "Because we don't know, therefore it ain't so."
In Washington, medications can go on and off the Preferred Drug List as more evidence develops. The P&T committee meets later this month, when its members will evaluate -- once again -- the safety of methadone.
* Database reporter Justin Mayo and news researchers David Turim and Gene Balk contributed to this report.
* Michael J. Berens: 206-464-2288 or mberens@seattletimes.com; Ken Armstrong: 206-464-3730 or karmstrong@seattletimes.com here
Since 2004, Yakima County has seen a total of 44 accidental methadone-related deaths. A Seattle Times analysis found statewide deaths occur in low-income areas at a rate three times higher than that of high-income areas. To save money, the state steers its Medicaid patients to methadone. Learn more of "Methadone and the politics of pain" special section by The Seattle Times
Click on a dot to see the age, sex, occupation and year of death for each decedent.
UPDATE: 6-7-2012 via Seattle Times:
Seattle Times methadone investigation wins Pulitzer Prize
Originally published April 16, 2012 at 1:08 PM | Page modified April 17, 2012 at 6:13 AM
Click on a dot to see the age, sex, occupation and year of death for each decedent.
UPDATE: 6-7-2012 via Seattle Times:
Seattle Times methadone investigation wins Pulitzer Prize
Originally published April 16, 2012 at 1:08 PM | Page modified April 17, 2012 at 6:13 AM
Seattle Times reporters Michael J. Berens and Ken Armstrong won the 2012 Pulitzer Prize in investigative reporting, while Eli Sanders of The Stranger won the Pulitzer in feature writing.
an few excerpts:
"In The Times' three-part series titled "Methadone and the Politics of Pain," Berens and Armstrong revealed that at least 2,173 people died in Washington state between 2003 and 2011 after accidentally overdosing on methadone, which for eight years was one of the state's two preferred painkillers for Medicaid patients and recipients of workers' compensation." (emphasis mine)"The Pulitzer citation honors Berens and Armstrong for "their investigation of how a little known governmental body in Washington State moved vulnerable patients from safer pain-control medication to methadone, a cheaper but more dangerous drug, coverage that prompted statewide health warnings."
Series brought changes
"The Times series reported that the poor have been hit hardest by the state's reliance on methadone. While Medicaid recipients make up about 8 percent of Washington's adult population, they account for 48 percent of the methadone deaths."
"State health officials had disregarded repeated warnings about methadone's risks, saying it was just as safe as any other painkiller."
"Immediately after the series was published in December, state Medicaid officials sent out an emergency advisory warning of the unique risks of methadone. In January, the state told doctors to use methadone only as a last resort."
"The warnings are likely to have an impact nationally, as Washington state's pain program had been considered a national model." read here
"The Times series reported that the poor have been hit hardest by the state's reliance on methadone. While Medicaid recipients make up about 8 percent of Washington's adult population, they account for 48 percent of the methadone deaths."
"State health officials had disregarded repeated warnings about methadone's risks, saying it was just as safe as any other painkiller."
"Immediately after the series was published in December, state Medicaid officials sent out an emergency advisory warning of the unique risks of methadone. In January, the state told doctors to use methadone only as a last resort."
"The warnings are likely to have an impact nationally, as Washington state's pain program had been considered a national model." read here
NOTE:
The discussion of methadone and psychotropic drugs begins on page 86
I read the transcripts of the Washington State PHARMACY AND THERAPEUTICS COMMITTEE MEETING that took place on February 18, 2009 and was deeply disturbed. The manner in which medical privileges are used is the underlying problem; it is an abuse of prescriptive privileges to prescribe drugs without evidence of safety and effectiveness of the prescription. This abuse of medical privilege is not discussed in meetings about the negative effects of the drugs and fatalities caused as a matter of course, which result from the standards used in clinical practice. Medical professionals have an ethical duty to report treatment providers whose patients are harmed by disabling iatrogenic illnesses, and to speak up on behalf of patients who die. Failure to report to the appropriate authorities in effect and in fact, makes a professional complicit; it is aiding and abetting criminal behavior after the fact. Coaching and advising medical professionals who are disabling and killing their patients is not enough; it allows them to harm other patients, while failing to be accountable for felonious medical assault and homicide. The focus of this committee meeting seemed to be the cost of the drugs, the potential for bad publicity and the fear of being held liable---
It is obvious that Medicaid fraud is not a concern of the Pharmacy and Therapeutics Committee committee. The committee met in February of 2009 and discussed once again, the number of deaths which are attributed to methadone for people on Medicaid. This was a discussion which had been going on for 3 or 4 years, according to the transcript. The policy was not changed until after the number of deaths were publicized in the Seattle Times. The fact that the committee members were aware of the high number of deaths for several years yet failed to act, makes it clear that the best interests of Medicaid patients are not a primary concern of the committee or Washington State's Medicaid program.
I read the transcripts of the Washington State PHARMACY AND THERAPEUTICS COMMITTEE MEETING that took place on February 18, 2009 and was deeply disturbed. The manner in which medical privileges are used is the underlying problem; it is an abuse of prescriptive privileges to prescribe drugs without evidence of safety and effectiveness of the prescription. This abuse of medical privilege is not discussed in meetings about the negative effects of the drugs and fatalities caused as a matter of course, which result from the standards used in clinical practice. Medical professionals have an ethical duty to report treatment providers whose patients are harmed by disabling iatrogenic illnesses, and to speak up on behalf of patients who die. Failure to report to the appropriate authorities in effect and in fact, makes a professional complicit; it is aiding and abetting criminal behavior after the fact. Coaching and advising medical professionals who are disabling and killing their patients is not enough; it allows them to harm other patients, while failing to be accountable for felonious medical assault and homicide. The focus of this committee meeting seemed to be the cost of the drugs, the potential for bad publicity and the fear of being held liable---
It is obvious that Medicaid fraud is not a concern of the Pharmacy and Therapeutics Committee committee. The committee met in February of 2009 and discussed once again, the number of deaths which are attributed to methadone for people on Medicaid. This was a discussion which had been going on for 3 or 4 years, according to the transcript. The policy was not changed until after the number of deaths were publicized in the Seattle Times. The fact that the committee members were aware of the high number of deaths for several years yet failed to act, makes it clear that the best interests of Medicaid patients are not a primary concern of the committee or Washington State's Medicaid program.
"Whenever a doctor cannot do good, he must be kept from doing harm."
Hippocrates
May 31, 2012
"The pharmaceutical industry is making money hand over fist while it systematically defrauds taxpayers"
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Sanders: Crack Down on Pharmaceutical Fraud May 23, 2012
WASHINGTON, May 23 - Sen. Bernie Sanders (I-Vt.) today proposed tough new penalties to combat rampant pharmaceutical industry fraud.
Sanders' amendment to a Food and Drug Administration bill before the Senate would take away exclusive marketing rights - potentially worth hundreds of millions of dollars - if a company is found to be at fault for fraud involving a particular drug.
"Companies that are fined for overcharging Medicare or Medicaid, or for dangerous illegal marketing practices, should not enjoy government-granted monopolies on those same medications," Sanders said.
The pharmaceutical industry achieved a dubious distinction in 2010 when the dollar amount of fraud against the government surpassed the notoriously-corrupt defense contracting industry, according to a Public Citizen study. Drug makers accounted for nearly half - $1.8 billion out of $4.1 billion -- of the penalties collected in 2011 by the Health Care Fraud and Abuse Control Program, a joint task force of the Department of Justice and the Department Health and Human Services. This year, pharmaceutical companies are expected to pay up to $9 billion under pending fraud settlements, according to Taxpayers Against Fraud.
While the penalties are steep, the amount pales in comparison to the huge revenues generated by illegal and fraudulent practices such as off-label marketing and price inflation. The top-12 pharmaceutical companies made $49.1 billion in profits in 2011, with Pfizer making $10 billion and Johnson and Johnson making $9.7 billion. "The penalties these companies pay when they are caught and prosecuted simply aren't big enough to stop them from being repeat offenders," Sanders said.
The senator described "a culture of fraud" that he said permeates the pharmaceutical industry. Over the past decade, virtually all of the major private pharmaceutical companies were involved in significant health care fraud. "The question arises, is fraud within the pharmaceutical industry the exception, or is it, simply put, their business model?"
The too-many-to-list examples include:
Abbott Labs, which agreed last month to pay $1.6 billion for illegally marketing the anti-seizure drug Depakote. The New York Times said the company also agreed to plead guilty to one misdemeanor charge for violating the Food, Drug and Cosmetic Act for misbranding.
Abbott Labs agreed to pay $421 million in 2010, along with two smaller companies, to settle charges that they deliberately spiked drug costs by up to 10 times the actual cost in order to boost reimbursements from Medicare and Medicaid.
Pfizer, which paid $49 million to settle charges that a subsidiary defrauded the Medicaid program by overcharging for the cholesterol-lowering drug Lipitor.
A division of Pfizer pleaded guilty to two felonies and agreed to pay $430 million to settle charges that it fraudulently promoted the drug Neurontin for a string of unapproved uses.
GlaxoSmithKline, which in 2011 reached an "agreement in principle" to pay $3 billion to conclude the company's most significant ongoing federal government investigations into illegal sales and marketing practices for a diabetes drug that was severely restricted last year after it was linked to heart risks.
Merck, which in 2009 reached a $670 million settlement for fraud on patients and Medicare/Medicaid involving a conspiracy with hospitals to give the elderly cheaper drugs but charging them for the more expensive product prescribed by the patients' doctors.
Merck last year pleaded guilty to a criminal misdemeanor charge and paid a $950 million settlement for illegally promoting Vioxx for rheumatoid arthritis before that use was approved. Vioxx was linked to thousands of heart attacks and sudden cardiac deaths before it was pulled from the market in 2004.
Johnson & Johnson last year illegally marketed Risperdal, an anti-psychotic medication, to nursing home patients, and paid over $2 billion in fines, a mere 6.3 percent of sales from the drug.
"And on and on it goes," Sanders said. "The bottom line is that the pharmaceutical industry is making money hand over fist while it systematically defrauds taxpayers, all the while individuals in the United States (let alone the developed world) are not getting the medicines they need because they cannot afford them."
Sanders' amendment would send a message to the drug industry that illegal behavior will not be rewarded with government-granted monopolies.
The proposal is backed by Public Citizen, U.S. Public Interest Research Group, the Consumer Federation of America, Consumers Union, the National Women's Health Network and the National Committee to Preserve Social Security and Medicare. here
photo credit healthexecnews.com
WASHINGTON, May 23 - Sen. Bernie Sanders (I-Vt.) today proposed tough new penalties to combat rampant pharmaceutical industry fraud.
Sanders' amendment to a Food and Drug Administration bill before the Senate would take away exclusive marketing rights - potentially worth hundreds of millions of dollars - if a company is found to be at fault for fraud involving a particular drug.
"Companies that are fined for overcharging Medicare or Medicaid, or for dangerous illegal marketing practices, should not enjoy government-granted monopolies on those same medications," Sanders said.
The pharmaceutical industry achieved a dubious distinction in 2010 when the dollar amount of fraud against the government surpassed the notoriously-corrupt defense contracting industry, according to a Public Citizen study. Drug makers accounted for nearly half - $1.8 billion out of $4.1 billion -- of the penalties collected in 2011 by the Health Care Fraud and Abuse Control Program, a joint task force of the Department of Justice and the Department Health and Human Services. This year, pharmaceutical companies are expected to pay up to $9 billion under pending fraud settlements, according to Taxpayers Against Fraud.
While the penalties are steep, the amount pales in comparison to the huge revenues generated by illegal and fraudulent practices such as off-label marketing and price inflation. The top-12 pharmaceutical companies made $49.1 billion in profits in 2011, with Pfizer making $10 billion and Johnson and Johnson making $9.7 billion. "The penalties these companies pay when they are caught and prosecuted simply aren't big enough to stop them from being repeat offenders," Sanders said.
The senator described "a culture of fraud" that he said permeates the pharmaceutical industry. Over the past decade, virtually all of the major private pharmaceutical companies were involved in significant health care fraud. "The question arises, is fraud within the pharmaceutical industry the exception, or is it, simply put, their business model?"
The too-many-to-list examples include:
Abbott Labs, which agreed last month to pay $1.6 billion for illegally marketing the anti-seizure drug Depakote. The New York Times said the company also agreed to plead guilty to one misdemeanor charge for violating the Food, Drug and Cosmetic Act for misbranding.
Abbott Labs agreed to pay $421 million in 2010, along with two smaller companies, to settle charges that they deliberately spiked drug costs by up to 10 times the actual cost in order to boost reimbursements from Medicare and Medicaid.
Pfizer, which paid $49 million to settle charges that a subsidiary defrauded the Medicaid program by overcharging for the cholesterol-lowering drug Lipitor.
A division of Pfizer pleaded guilty to two felonies and agreed to pay $430 million to settle charges that it fraudulently promoted the drug Neurontin for a string of unapproved uses.
GlaxoSmithKline, which in 2011 reached an "agreement in principle" to pay $3 billion to conclude the company's most significant ongoing federal government investigations into illegal sales and marketing practices for a diabetes drug that was severely restricted last year after it was linked to heart risks.
Merck, which in 2009 reached a $670 million settlement for fraud on patients and Medicare/Medicaid involving a conspiracy with hospitals to give the elderly cheaper drugs but charging them for the more expensive product prescribed by the patients' doctors.
Merck last year pleaded guilty to a criminal misdemeanor charge and paid a $950 million settlement for illegally promoting Vioxx for rheumatoid arthritis before that use was approved. Vioxx was linked to thousands of heart attacks and sudden cardiac deaths before it was pulled from the market in 2004.
Johnson & Johnson last year illegally marketed Risperdal, an anti-psychotic medication, to nursing home patients, and paid over $2 billion in fines, a mere 6.3 percent of sales from the drug.
"And on and on it goes," Sanders said. "The bottom line is that the pharmaceutical industry is making money hand over fist while it systematically defrauds taxpayers, all the while individuals in the United States (let alone the developed world) are not getting the medicines they need because they cannot afford them."
Sanders' amendment would send a message to the drug industry that illegal behavior will not be rewarded with government-granted monopolies.
The proposal is backed by Public Citizen, U.S. Public Interest Research Group, the Consumer Federation of America, Consumers Union, the National Women's Health Network and the National Committee to Preserve Social Security and Medicare. here
photo credit healthexecnews.com
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