Another Day at the Pharma: Pfizer fined 107 Million in Overbilling

This is a report via Reuters

Britain’s competition watchdog has fined Pfizer a record 84.2 million pounds (US$107 million) for its role in ramping up the cost of an epilepsy drug by as much as 2,600 percent.
In the case of phenytoin sodium capsules, the UK price charged for 100 mg packs of the drug jumped from 2.83 pounds to 67.50 in 2012, before reducing to 54.00 from May 2014.
As a result, annual spending on the capsules by Britain’s National Health Service rose from 2 million pounds in 2012 to about 50 million in 2013. The CMA said UK prices were many times higher than elsewhere in Europe.
Pfizer used to market the medicine under the brand name Epanutin but sold the rights to Flynn, a privately owned British company, in September 2012.
It was then debranded, meaning that it was no longer subject to price regulation, and the price soared.
“The companies deliberately exploited the opportunity offered by debranding to hike up the price for a drug which is relied upon by many thousands of patients,” Philip Marsden, chairman of the CMA’s case decision group, said on Wednesday.
“This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behavior.”
Pfizer said in a statement it planned to appeal all aspects of the CMA’s verdict.
The U.S. drug maker said the medicine had been loss-making and it was therefore forced to consider whether it could continue supplying it. Pfizer added that the price set by Flynn was actually 25 to 40 percent less than the cost of an equivalent tablet form from another supplier.
Flynn also plans to appeal. Chief executive David Fakes said punishing Flynn for selling phenytoin capsules for less than phenytoin tablets “beggars’ belief”.

Wisconsin Officer Exonerated and a Teen is Deceased, but is Pfizer Exonerated?

According to the Wisconsin Dane County DA a March 6 shooting of Tony Terrell Robinson Jr. was "lawful."
NBCnews reported that some of the evidence was recently released from the scene of the shooting, including dashcam videos taken from police cruisers. The Dane County district attorney said that Robinson, 19, had Xanax, mushrooms and marijuana in his system. Witnesses described him as acting erratically while on drugs that evening. End News Report.
Xanax is a product of Pfizer, and some of the side effects are irritability, trouble concentrating, fear or nervousness, inability to sit still, mood or mental changes. Rare side effects are actions that are out of control, feeling jittery. Hmm, according to the police report this young teen was acting erratic and out of control, and punched the officer. It seems like this young man was feeling the effects of Xanax and hallucinogenic mushrooms as well as marijuana. But will Pfizer be exonerated well certainly. The protesters are concentrating on the police incident and not that the teen was as the mercy of Pfizer’s drugs.
We should all protest Pfizer’s headquarters and hold them to account. Their Xanax drug was an element in the cause of this police incident and the death of this teen.

Has America Become a Nation of Psychotics on Psychotics?

(photovecteezy)

An article reprint by James Ridgeway who writes for The Guardian newspaper, and is the senior Washington correspondent for Mother Jones magazine.

You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux.
Once upon a time, antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses - primarily schizophrenia and bipolar disorder - to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics. Parents are told that their unruly kids are in fact bipolar, and in need of anti-psychotics, while old people with dementia are dosed, in large numbers, with drugs once reserved largely for schizophrenics. Americans with symptoms ranging from chronic depression to anxiety to insomnia are now being prescribed anti-psychotics at rates that seem to indicate a national mass psychosis.
It is anything but a coincidence that the explosion in antipsychotic use coincides with the pharmaceutical industry's development of a new class of medications known as "atypical antipsychotics." Beginning with Zyprexa, Risperdal, and Seroquel in the 1990s, followed by Abilify in the early 2000s, these drugs were touted as being more effective than older antipsychotics like Haldol and Thorazine. More importantly, they lacked the most noxious side effects of the older drugs - in particular, the tremors and other motor control problems.
The atypical anti-psychotics were the bright new stars in the pharmaceutical industry's roster of psychotropic drugs - costly, patented medications that made people feel and behave better without any shaking or drooling. Sales grew steadily, until by 2009 Seroquel and Abilify numbered fifth and sixth in annual drug sales, and prescriptions written for the top three atypical antipsychotics totaled more than 20 million. Suddenly, antipsychotics weren't just for psychotics any more.
Not just for psychotics anymore
By now, just about everyone knows how the drug industry works to influence the minds of American doctors, plying them with gifts, junkets, ego-tripping awards, and research funding in exchange for endorsing or prescribing the latest and most lucrative drugs. "Psychiatrists are particularly targeted by Big Pharma because psychiatric diagnoses are very subjective," says Dr. Adriane Fugh-Berman, whose Pharmed Out project tracks the industry's influence on American medicine, and who last month hosted a conference on the subject at Georgetown. A shrink can't give you a blood test or an MRI to figure out precisely what's wrong with you. So it's often a case of diagnosis by prescription. (If you feel better after you take an anti-depressant, it's assumed that you were depressed.) As the researchers in one study of the drug industry's influence put it, "the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." For this reason, they argue, it's particularly important that the guidelines for diagnosing and treating mental illness be compiled "on the basis of an objective review of the scientific evidence" - and not on whether the doctors writing them got a big grant from Merck or own stock in AstraZeneca
Marcia Angell, former editor of the New England Journal of Medicine and a leading critic of the Big Pharma, puts it more bluntly: "Psychiatrists are in the pocket of industry." Angell has pointed out that most of the Diagnostic and Statistical Manual of Mental Disorders (DSM), the bible of mental health clinicians, have ties to the drug industry. Likewise, a 2009 study showed that 18 out of 20 of the shrinks who wrote the American Psychiatric Association's most recent clinical guidelines for treating depression, bipolar disorders, and schizophrenia had financial ties to drug companies.

In a recent article in The New York Review of Books, Angell deconstructs what she calls an apparent "raging epidemic of mental illness" among Americans. The use of psychoactive drugs—including both antidepressants and antipsychotics—has exploded, and if the new drugs are so effective, Angell points out, we should "expect the prevalence of mental illness to be declining, not rising." Instead, "the tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 - from one in 184 Americans to one in seventy-six. For children, the rise is even more startling - a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children." Under the tutelage of Big Pharma, we are "simply expanding the criteria for mental illness so that nearly everyone has one." Fugh-Berman agrees: In the age of aggressive drug marketing, she says, "Psychiatric diagnoses have expanded to include many perfectly normal people."
Cost benefit analysis
What's especially troubling about the over-prescription of the new antipsychotics is its prevalence among the very young and the very old - vulnerable groups who often do not make their own choices when it comes to what medications they take. Investigations into antipsychotic use suggest that their purpose, in these cases, may be to subdue and tranquilize rather than to treat any genuine psychosis.
Carl Elliott reports in Mother Jones magazine: "Once bipolar disorder could be treated with atypicals, rates of diagnoses rose dramatically, especially in children. According to a recent Columbia University study, the number of children and adolescents treated for bipolar disorder rose 40-fold between 1994 and 2003." And according to another study, "one in five children who visited a psychiatrist came away with a prescription for an antipsychotic drug."
A remarkable series published in the Palm Beach Post in May true revealed that the state of Florida's juvenile justice department has literally been pouring these drugs into juvenile facilities, "routinely" doling them out "for reasons that never were approved by federal regulators." The numbers are staggering: "In 2007, for example, the Department of Juvenile Justice bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children…That's enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day." Further, the paper discovered that "One in three of the psychiatrists who have contracted with the state Department of Juvenile Justice in the past five years has taken speaker fees or gifts from companies that make antipsychotic medications."
In addition to expanding the diagnoses of serious mental illness, drug companies have encouraged doctors to prescribe atypical anti-psychotics for a host of off-label uses. In one particularly notorious episode, the drugmaker Eli Lilly pushed Zyprexa on the caregivers of old people with Alzheimer's and other forms of dementia, as well as agitation, anxiety, and insomnia. In selling to nursing home doctors, sales reps reportedly used the slogan "five at five"meaning that five milligrams of Zyprexa at 5 pm would sedate their more difficult charges. The practice persisted even after FDA had warned Lilly that the drug was not approved for such uses, and that it could lead to obesity and even diabetes in elderly patients.

In a video interview conducted in 2006, Sharham Ahari, who sold Zyprexa for two years at the beginning of the decade, described to me how the sales people would wangle the doctors into prescribing it. At the time, he recalled, his doctor clients were giving him a lot of grief over patients who were "flipping out" over the weight gain associated with the drug, along with the diabetes. "We were instructed to downplay side effects and focus on the efficacy of drug…to recommend the patient drink a glass a water before taking a pill before the meal and then after the meal in hopes the stomach would expand" and provide an easy way out of this obstacle to increased sales. When docs complained, he recalled, "I told them, ‘Our drug is state of the art. What's more important? You want them to get better or do you want them to stay the same--a thin psychotic patient or a fat stable patient.'"
For the drug companies, Shahrman says, the decision to continue pushing the drug despite side effects is matter of cost benefit analysis: Whether you will make more money by continuing to market the drug for off-label use, and perhaps defending against lawsuits, than you would otherwise. In the case of Zyprexa, in January 2009, Lilly settled a lawsuit brought by with the US Justice Department, agreeing to pay $1.4 billion, including "a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind,''the Department of Justice said in announcing the settlement." But Lilly's sale of Zyprexa in that year alone was over $1.8 billion.

Making patients worse

As it turns out, the atypical antipsychotics may not even be the best choice for people with genuine, undisputed psychosis.
A growing number of health professionals have come to think these drugs are not really as effective as older, less expensive medicines which they have replaced, that they themselves produce side effects that cause other sorts of diseases such as diabetes and plunge the patient deeper into the gloomy world of serious mental disorder. Along with stories of success come reports of people turned into virtual zombies.
Elliott reports in Mother Jones: "After another large analysis in The Lancet found that most atypicals actually performed worse than older drugs, two senior British psychiatrists penned a damning editorial that ran in the same issue. Dr. Peter Tyrer, the editor of the British Journal of Psychiatry, and Dr. Tim Kendall of the Royal College of Psychiatrists wrote: "The spurious invention of the atypicals can now be regarded as invention only, cleverly manipulated by the drug industry for marketing purposes and only now being exposed."
Bottom line: Stop Big Pharma and the parasitic shrink community from wantonly pushing these pills across the population.

Antidepressant Linked to Cause Autism When Used by Pregnant Women

A recent article from SFgate.com and other news sources indicates that a recent study published in Archives of General Psychiatry, looked at the possible role of maternal antidepressant use before and during pregnancy. Prenatal Children whose mothers take Prozac, Zolft, or similar SSRI antidepressants during pregnancy are twice as likely as other children to have a diagnosis of autism or similar disorder. The study of 298 autistic children in the Kaiser Permanente Northern California system found a two fold increase in risk of the disorder when mothers took antidepressants at some point in the year before giving birth.
The study doesn't prove that the antidepressants actually caused autism, but it shows that genetics is not the sole reason for autism. Environmental issue can cause autism and antidepressants appear to be a common cause. We hope and expect there will be more studies, but we are not surprised of the results.

"The problem with our 'treatment procedures' is that, unlike standard medical practices, we have no way to verify the true cause of the problem or the effectiveness of our 'solutions'. We have gone from hot/cold baths, to lobotomies, to electric shocks, to psychotropic drugs - with no proof of any kind. If other MDs treated a broken arm the way we treat the human brain they would be in court. And so, more and more, that is where we find ourselves." Dr. Thomas Szasz MD, chair of psychiatry, Syracuse University.

Antidepressants Do Not Work to Treat Autism Either

The U.S. Food and Drug Administration (FDA) has not approved any medications to specifically treat autism, but they have approved three SSRIs sertraline (Zoloft), fluoxetine (Prozac) and fluvoxamine (Luvox) to alleviate certain symptoms of the illness. But research indicated that these antidepressants also provide no benefits.
Another study found that the antidepressant citalopram (Celexa) is not any better than a placebo at alleviating autism symptoms. Additionally researchers concluded that studies of other antidepressants revealed the same results.

Besides not working, these antidepressants often cause major side effects, especially in young people. In the citalopram study, one child participant developed severe seizures from taking the drug. Even after being taken off it, the child continued to have seizures. Other children taking it had a hard time sleeping and concentrating. Hard time concentrating is a symptom of autism, so the study shows the so called alleviate is causing the problem.

It must be devasting for a mother to have an autistic child, but what is worse is the potential prescription of an antidepressant is actually causing the life long problem for the child. The responsibility lies heavily on the pharmaceutical companies that produced these drugs Eli Lilly(prozac), Pfizer(zolft), Solvay(Luvox), GlaxoSmithkline(Paxil), Forest Labs(Celexa). There are class action lawsuit currently by baumhedlundlaw.com, rxbirthdefects.com and others