GlaxoSmithKline settles healthcare fraud case for $3 billion

By David Ingram - Reuters

WASHINGTON (Reuters) – GlaxoSmithKline Plc agreed to plead guilty to misdemeanor criminal charges and pay $3 billion to settle what government officials on Monday described as the largest case of healthcare fraud in U.S. history.

The agreement, which still needs court approval, would resolve allegations that the British drugmaker broke U.S. laws in the marketing and development of pharmaceuticals.

GSK targeted the antidepressant Paxil to patients under age 18 when it was approved for adults only, and it pushed the drug Wellbutrin for uses it was not approved for, including weight loss and treatment of sexual dysfunction (one of its side effects is sexual dysfunction), according to an investigation led by the U.S. Justice Department.

The company went to extreme lengths to promote the drugs, such as distributing a misleading medical journal article and providing doctors with meals and spa treatments that amounted to illegal kickbacks, prosecutors said.

In a third instance, GSK failed to give the U.S. Food and Drug Administration safety data about its diabetes drug Avandia, in violation of U.S. law, prosecutors said.

The misconduct continued for years beginning in the late 1990s and continued, in the case of Avandia’s safety data, through 2007. GSK agreed to plead guilty to three misdemeanor criminal counts, one each related to the three drugs.

Guilty pleas in cases of alleged corporate misconduct are exceedingly rare, making GSK’s agreement especially unusual.

The agreement to settle the charges “is unprecedented in both size and scope,” said James Cole, the No. 2 official at the U.S. Justice Department. He called the action “historic” and “a clear warning to any company that chooses to break the law.”

The settlement includes $1 billion in criminal fines and $2 billion in civil fines.

GSK said in a statement it would pay the fines through existing cash resources. The company announced a $3 billion charge in November related to legal claims [ID:nL5E7M315A].

NEW ‘ERA’ AT GSK

Chief Executive Officer Andrew Witty said the misconduct originated “in a different era for the company” and will not be tolerated. “I want to express our regret and reiterate that we have learnt from the mistakes that were made,” he said in a written statement.

The GSK settlement surpasses what had been the largest criminal case involving a drugmaker in U.S. history. In 2009, Pfizer Inc agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs.

The cases follow a trend of U.S. authorities cracking down on how pharmaceuticals are sold, in part because of the rising cost of providing drugs through government programs.

Part of civil fines address allegations that, from 1994 to 2003, GSK underpaid money owed to Medicaid, the healthcare program for the poor run jointly by states and the federal government. The company had an obligation to tell the government its “best prices” but failed to do so, prosecutors said, and $300 million of the settlement will go to states and other public health authorities.

A portion of the $2 billion in civil fines may go to a group of whistleblowers who contributed to the government’s investigation and who are eligible to share in the recovery under the False Claims Act. Cole said the amount has not been determined.

‘INTEGRITY’ PLAN

As part of the settlement, GlaxoSmithKline agreed to new restrictions by the U.S. government to prevent the use of kickbacks or other prohibited practices. The inspector general of the U.S. Department of Health and Human Services will oversee the “Corporate Integrity Agreement” for five years.

The company will not be able to compensate its salesmen based on sales goals for territories. It was also required to change its executive compensation program to allow the company to “claw back” certain pay for those engaged in misconduct.

Witty said GSK’s U.S. unit has “fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct.”

Prosecutors have not brought criminal charges against any individuals in connection with the GSK case, although the settlement expressly leaves open that possibility. Cole declined to comment on the possibility of future charges.

Almost exactly a year ago GSK agreed to pay nearly $41 million to 37 states and the District of Columbia in an unrelated case about substandard manufacturing processes at a Puerto Rico factory.

In 2010, the company took a $2.4 billion charge in connection with Avandia to settle claims from patients.

GSK’s shares were positive on the New York Stock Exchange on Monday, up 1.6 percent to $46.29 at 1400 EDT.

The case is U.S. v. GlaxoSmithKline LLC, U.S. District Court for the District of Massachusetts, No. 12-cr-10206.

When Big Pharma Writes the Laws

Move Over ALEC!

by MARTHA ROSENBERG

Just like ALEC, Big Pharma is doing the job of elected officials by writing legislation-ready bills for no charge, says the New York Times.  The new bills seek to prevent health insurers from raising co-pay amounts to a price where patients are unable or unwilling to buy them, especially with expensive drugs. When co-pays rise too high, many people engage in what Pharma calls “prescription abandonment”–leaving the prescription at the pharmacy “altar” or not refilling future prescriptions.

Pharma is losing so much money from rising co-pays and prescription abandonment, it has launched cagey, public service announcement-sounding campaigns about “patients not taking the drugs they need,” as if it is a health and not revenue issue. Pharma has even instituted arrangements with some pharmacies to send visiting nurses to patients’ homes to ensure “compliance,” Big Brother overtones notwithstanding.

Prescription abandonment is an especially thorny issue for Pharma when the drugs are taken on faith, to reduce patients’ “risks” and patients do not necessarily feel them working. It is also a thorny issue when studies suggest the drugs being abandoned may not be necessary to begin with or working.

One such expensive placebo is the drug known by the brand name Risperdal. The Department of Veterans Affairs spent $717 million on the drug to treat posttraumatic stress disorder in Afghanistan and Iraq troops with PTSD over nine years, only to discover it worked no better than a sugar pill! Veterans Affairs doctors wrote more than 5 million prescriptions from 2000 through June 2010 for naught, says a 2011 paper in the Journal of the American Medical Association (JAMA).

Last month, Johnson & Johnson also agreed to pay $1.2 billion in fines for minimizing or concealing Risperdal’s  dangers. Many say unless a drug company’s chief officers go to prison or the company is banned from sales to Medicare and other government programs, penalties are a joke. Wall Street did not punish J&J stock after the Risperdal settlement and actually rewarded Abbott this week after a $1.6 billion settlement for mismarketing the seizure drug Depakote! Hello?

Nor did the JAMA revelations about Risperdal dry up government sales. Less than two weeks after the study was published, the VA awarded a contract for more than 200,000 bottles of generic risperidone, said published reports, containing more than $20 million pills.

Of course, people-aren’t-taking-their-drugs is not Pharma’s only faux PSA campaign. Big bucks are also going into a campaign to prevent patients “abusing” prescription drugs, as  if Pharma billions  in marketing

While no one wants sick people to go without their drugs, some say the Pharma-concocted bills are designed to change the debate over the cost of exorbitant drugs to coverage issues over who pays for them–thus giving “the drug companies a free ride to charge as much as they want.” Pharma is even using patient front groups to whip up a contrived demand for expensive drugs, some charge.

Patients may seem to benefit from the proposed co-pay legislation but health care costs and taxes actually skyrocket as Pharma tries to pass along the cost of expensive brand name drugs that may not even be necessary and are often less effective than cheaper drugs. Some don’t work at all.

An example of how Pharma is trying to play the co-pay card for its revenue stream is seen in a recent article in the Journal of the American Medical Association, called “Out-of-Pocket Medication Costs and Use of Medications and Health Care Services Among Children With Asthma.” Increased co-pay is resulting in less use of the asthma “controller medications” say the authors, who have links to Pfizer, Novartis and Bristol-Myers Squibb, three large drug companies. Asthma controller medications are drugs added on top of  rescue inhalers or inhaled corticosteroids like Advair, Singulair, Symbicort, and Accolate.  But data published by Medco, the nation’s largest pharmacy benefit manager, says the controller drugs reduce neither trips to the ER or hospitalizations when taken by a large amount of patients. Worse–some reports say the controller asthma medications actually make asthma worse.

Do we really need laws written by Pharma to help “buy” drugs that may be worthless or even make us worse?

Researchers Hid, Ignored Bad Results in Massive Drug Trial Corruption

April 17, 2012
Patrick Gallagher | NaturalSociety

Pharmaceutical medication has always been very highly regarded in society, and its continued use shows that many individuals seem to use it without knowing — or more likely, even thinking — about the content of the drugs that they so hastily consume. Recently there has been yet another study that shows the Food and Drug Administration, trusted by millions and yet funded with trillions to overlook some of the most detrimental health risks, cares even less about drug trial regulation than previously thought.

The study reveals the varied corruption deeply rooted within the FDA, vying for approval of drugs that serve no medical purpose, sometimes with more harmful effects than good. Specifically, the drug Tamiflu (oseltamivir) — the drug praised as the be all end all cure for the ‘deadly swine flu epidemic‘.

The entire article debunks the use and distribution of the effectively worthless drug, as well as the FDA’s reasons for approval:

“If sales can be considered a proxy for utility, the controversies surrounding even the most successful drugs (such as blockbuster drugs) seem all the more paradoxical, and have revealed the extent to which the success of many drugs has been driven by sophisticated marketing rather than verifiable evidence… Prior to the global outbreak of H1N1 influenza in 2009, the United States alone had stockpiled nearly US$1.5 billion dollars worth of the [drug].”

The researchers continue:

“This analysis, conducted by Kaiser and colleagues, proposed that oseltamivir treatment of influenza reduced both secondary complications and hospital admission. In contrast, the Food and Drug Administration (FDA), which approved Tamiflu in 1999 and was aware of these same clinical trials, concluded that Tamiflu had not been shown to reduce complications, and required an explicit statement in the drug’s label to that effect.”

This study only covers one single drug that has only been approved solely for profiteering; the FDA is known to have approved thousands upon thousands of commercial drugs from the big pharmaceutical corporations over the decades, with many questioning their serious side effects. Such is the case with highly-popular cancer drugs, which have been shown to make cancer worse and actually kill the patient more quickly. It has become abundantly clear that citizens cannot and should not place any sort of trust in many of these corporate-pushed these medications and their supposed ‘benefits’.

Cited:http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001201http://blogs.mercola.com/sites/vitalvotes/archive/2012/04/13/massive-corruption-revealed-to-be-at-the-core-of-many-drug-approvals.aspx

Drugmakers have paid $8 billion in fraud fines

By Kelly Kennedy, USA TODAY

WASHINGTON – The nation's largest drugmakers have paid at least $8 billion in fines for repeatedly defrauding Medicare and Medicaid over the past decade, but they remain in business with the federal government because they are often the sole suppliers of critical products, records show.

Pfizer, the maker of drugs that help alleviate arthritis and other ailments, has paid almost $3 billion in fines since 2002 and entered into three corporate integrity agreements with the Department of Health and Human Services aimed at preventing future fraud. It and other companies are fighting attempts by Congress to exclude them from government business because of their history of fraud.  Pfizer spent $12 million lobbying Congress in 2011.

Merck, another pharmaceutical giant, paid $1.6 billion in fines since 2008, Medicare and Justice Department records show, to resolve claims it was not paying proper rebates to the government.

Pfizer's 2009 settlement was for improperly promoting the use of drugs for purposes other than those for which they were approved by the government. Merck's 2008 settlement involved claims the company paid illegal kickbacks to health care providers in exchange for prescribing its drugs.

Government investigators say their hands are tied with the tools they have. They can exclude Pfizer and other pharmaceutical companies from providing medications to Medicaid and Medicare beneficiaries as punishment for bad behavior, but that would leave beneficiaries without drugs patented through a particular company.

Or they can fine the companies and force them to enter corporate integrity agreements that require government oversight and a promise not to defraud the government again — a promise that often goes unkept.

"We're seeing some of the big companies a second and third time," said Gregory Demske, assistant inspector general for legal affairs for Health and Human Services. "The corporate integrity agreement is not sufficient to deter further misconduct."

In addition, the cases are labor- and cost-intensive as the companies fight often for years to avoid an exclusion, Demske said.

To try to change that trend, the government announced in 2010 that, rather than exclude an entire company, investigators would go after individuals within a company. Demske said his organization, the Justice Department and the Food and Drug Administration have come up with some ideas to use within the scope of the rules — such as taking away a company's patent rights as a condition of a settlement. That could begin with cases being investigated now, he said.

Sen. Chuck Grassley, R-Iowa, introduced a bipartisan bill that would make it easier for the government to find a middle ground, saying the law now forces "the inspector general to use all-or-nothing, mandatory exclusion penalties against corporations that have committed fraud." The bill would allow the exclusion of individuals from working with the government even after they've left the company where the fraud occurred.

Pharmaceutical companies altogether spent more than $200 million lobbying Congress in 2011, including $12 million spent by Pfizer. At least 12 pharmaceutical and medical device companies are lobbying specifically against a House bill, HR 675, that complements Grassley's.

None of the pharmaceutical companies —Abbott Laboratories, Pfizer or Bristol-Myers Squibb— contacted by USA TODAY responded to questions about their response to the government's proposed enforcement actions.

The industry's trade group, the Pharmaceutical Research and Manufacturers of America, says excluding an individual should occur only when there is "significant wrongdoing" that the individual knew about and did nothing to stop, said Matthew Bennett, the group's senior vice president.

Corporate Crime in the Pharmaceutical Industry

The Scandal of Reincarnated Rats
by RUSSELL MOKHIBER

John Braithwaite is back.

The famed Australian corporate criminologist is teaming up with a former European pharmaceutical executive – Graham Dukes – and together they are completing a new book on corporate crime in the pharmaceutical industry.

The working title – Corporations, Crime and Medicines.

It’s due out early next year.

Thirty years ago, Braithwaite finished his magnum opus – Corporate Crime in the Pharmaceutical Industry (Routledge Kegan & Paul).

The book documented widespread fraud and corruption worldwide.

“In the latter part of the 1980s, I thought that the pharmaceutical industry was actually improving in its standards,” Braithwaite told Corporate Crime Reporter in an interview. “Ciba Geigy was one company that had come under particularly aggressive attack from the consumer movement. And Ciba Geigy was responding and setting up corporate social responsibility policies with a new risk management initiative that it was trying to get other companies to join up with.”

“Pfizer became the number one company in the industry. It was sending senior executives to Australia to talk to me. They were really interested in what kind of internal procedures they could be putting in place to make sure that folks like Graham and I would not be making the kinds of critiques that were in Corporate Crime in the Pharmaceutical Industry.”

“I was encouraged by that. I think actually I wasn’t conned. In the course of the 1980s, there was progress.”

“I actually finished the research for Corporate Crime in the Pharmaceutical Industry in 1980. But the book was held up for concerns about libel.”

“But 30 years on, the situation has in fact become worse in most respects. Perhaps there has been some improvement in terms of safety and manufacturing processes among the majors. But on the other hand, the largest pharmaceutical corporations in the world have done a major disservice in the way they have approached the generic industry and, in a sense, stigmatized the generic industry.”

“In Corporate Crime in the Pharmaceutical Industry, we concluded that 19 of the 20 largest U.S. pharmaceutical companies had engaged in serious corrupt activities in the course of the 1970s. And there was really no other industry in the United States that had such a consistent pattern. There were other industries – like the defense industry – that were doing terribly corrupt things. But in terms of top to bottom corruption, the pharmaceutical industry was the worst in the United States.”

“And in some ways, we are inclined to conclude that today it is even worse.”

In the area of research fraud, things are again worse 30 years later.

“A big part of the 1984 book was fraud in safety and testing of drugs,” Braithwaite said. “Remember the GD Searle company, of which Donald Rumsfeld was a CEO? They had the scandal of reincarnated rats. The rats would die when a drug was tested on them. And they would be replaced with living rats. That kind of blatant fraud is not dead in the pharmaceutical industry. There is a lot more sophisticated fraud in the form of suppression of negative safety and efficacy studies. And the boosting of positive studies.”

“But still, there is quite a lot of plain old fashion losing of negative data. And that is the same as the throwing away of the dead rat and replacing the dead rat with the reincarnated rat.”

“You generate data that a drug does not work. And you just suppress that data. It’s as if the study were never conducted and you start again and do another study until you get one that shows you what you want to find. Go to another university professor who will tell you what you want to hear.”

“That situation is, if anything. worse rather than better.”

On the Wall Street meltdown, Braithwaite says the situation could have easily been prevented.

“There was a lot of evidence that there was systemic mortgage fraud – liar loans, false representation of income and employment status of people on loans,” Braithwaite said. “And that had to do with a shift of the nature of capitalism. Banks issuing loans were no longer as interested as they should have been in assessing the capacity of the borrower to repay. Why? Because it was a move from a risk management financial sector to a risk shifting financial sector. You just slice and dice the loans and spread the risk around to a lot of other banks.”

“But it seems to me that there was a ready regulatory response to that. It was knowable that there was a problem. You had the FBI reporting as early as 2004 and 2005 that there was an epidemic of mortgage fraud in the United States. You had this huge trend up in housing loan defaults starting in the mid 2000s. These were very clear red flags.”

“The simple regulatory strategy was for prudential regulators to go to mortgage brokers and banks and say – look, your portfolio of loans has twice the default rate of the average in our state. We want to sit down with you and look into why that is. And if that very simple regulatory inspection measure had been taken, it would have quickly become apparent that there was a pattern of fraud in the loans that they were issuing. And that would have been the early preventive step.”

“And you wouldn’t have necessarily had to prosecute those banks. You would have wanted to go around the country and stop the problem. That would be the most important thing. You would prosecute the ones with the worst patterns of conduct. But the more important thing would be return to integrity in the way loans are issued. Banks return to being interested in ensuring that these were levels of repayment that could be made.”

How Big Pharma Hooked Americans on Drugs

Saturday, July 16, 2011 by Al-Jazeera-English
Mass Psychosis in the US:
by James Ridgeway

 

Has America become a nation of psychotics? 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 anymoreBy 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 PharmedOut 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 analysisWhat'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 suggests 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 were 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 comes 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.

Ask Not for Whom the Drug Tolls

Wendy McElroy - January 25, 2011
The Freeman

“Fifty years ago, it made sense to assert that mental illnesses are not diseases, but it makes no sense to say so today. Debate about what counts as mental illness has been replaced by legislation about the medicalization and demedicalization of behavior. Old diseases such as homosexuality and hysteria disappear. New diseases such as gambling and smoking appear.” So writes the iconoclastic psychiatrist Thomas Szasz.

Almost 50 years ago Szasz published The Myth of Mental Illness. It changed the political framework in which mental illness was addressed by laying the foundation for a concept Szasz developed through a series of books, including The Manufacture of Madness (1970). That concept was “the Therapeutic State”—a collaboration between psychiatry and the State through which “undesirable” actions, thoughts, and behavior patterns were suppressed. Thus Szasz not only disputed the moral and scientific basis of psychiatry but also argued that modern medicine was an engine of social control, with pharmaceuticals as primary tools.

A new slate of drugs now addresses a wide range of so-called disorders, or dysfunctions, that former generations considered environmental problems or lifestyle choices: from obesity to attention deficit, from erectile dysfunction to social anxiety (shyness), from menopause to alcoholism. Indeed, laziness is now being discussed as “a neuro-developmental dysfunction” for which drugs are being developed. The current Therapeutic State may be best analyzed as a collaboration between modern medicine, the pharmaceutical industry, and the State.

The debate stirred by Szasz has muted. The medical establishment and mainstream media are now advocates of the Therapeutic State. Similar advocates dominate universities, studies, prestigious committees, FDA hearings, and governmental bodies. Since writing The Myth, Szasz himself has noted that “the formerly sharp distinctions between medical hospitals and mental hospitals, voluntary and involuntary mental patients, and private and public psychiatry have blurred into nonexistence. Virtually all medical and mental health care is now the responsibility of and is regulated by the federal government, and its cost paid, in full or in part, by the federal government.” Problems of everyday life have been medicalized, and people are viewed as having little or no ability to “cure” conditions such as alcoholism or drug abuse through willpower or change of habit. The focus Szasz tried to foster on the individual’s responsibility for his or her own dysfunctions has eroded.

Happily, a backlash against the medicalization of everyday life is occurring. Alas, it is being fought on the wrong ground.

In this regard, a fascinating book has just been published. Sex, Lies, and Pharmaceuticals: How Drug Companies Plan to Profit from Female Sexual Dysfunction by Ray Moynihan and Barbara Mintzes is a work of investigative journalism that explores the close financial relationship between the medical experts who define and develop the “science” behind new dysfunctions and the $500-plus billion pharmaceutical industry that profits from treating them. For example, Moynihan examines the makeup of experts on committees that define dysfunctions for the extremely influential Diagnostic and Statistical Manual of Mental Disorders (DSM); it is from the DSM that “social anxiety disorder” derives. (Revealingly, homosexuality was only delisted as a disorder in 1970.) Moynihan observes, “The DSM has been criticised for the closeness between the expert committees who write the definition of diseases and the pharmaceutical companies that sell the drugs prescribed to treat them. One study that looked closely at the affiliations of the men and women on those committees found that more than half of them had ties to drug companies. On the committees revising mood disorders, including depression, the figure was closer to 100 per cent.”

In short, he constructs a strong case for endemic bias within the medical establishment in favor of drug companies and the creation of disease.

Another sign of backlash is the emergence of grassroots rebellions against specific “diseases,” such as the currently emerging “female sexual dysfunction,” and against the use of drugs, such as Ritalin, to “cure” attention deficit disorder in children.

A reopening of debate on medicalizing everyday life is to be applauded. But, unlike Szasz, the new critics, such as Moynihan, do not take aim at the Therapeutic State; instead they focus on the therapeutic industry—that is, the flow of money between the medical establishment and the pharmaceutical companies. The culpability of the government in the creation of disease is either marginalized or denied.

Other pharmaceutical dissidents tend to view the State as the solution, not part of the problem. For example, feminist activist Leonore Tiefer works through the World Health Organization to impose new legislation that promotes such “rights” (or entitlements) as “the right to comprehensive sexuality education” and “the right to sexual health care, which should be available for prevention and treatment of all sexual concerns, problems, and disorders.”

It is possible that critics like Moynihan and Tiefer will accomplish some good. Perhaps they will be able to reduce the widespread prescription of the powerful Ritalin to grade-school children. But without understanding the essential role played by the State in the medicalization of everyday life, critics can never strike at the root of the problem. Indeed, they may well worsen matters by shifting blame and giving more authority to the very agency most responsible for the creation of disease.

The Need for a New Focus

The focus of the reemerging debate needs to shift onto Szaszian grounds, onto an analysis of the Therapeutic State, in at least four ways.

First, it must be clear that government defines the framework for all medical practices within North America. Second, the protection offered to pharmaceutical companies should be analyzed as legal privilege. Third, the relatively new and influential “private-public partnerships”—a marriage between the corporate sector and government institutions—should be examined and exposed. And, fourth, the role government plays in “marketing” drugs through institutions like the public school system and social services must be examined.

Government framework. There is no genuine competition allowed in the practice of medicine or the administration of drugs. Both of these vital functions of society are monopolies that the government assigns to those who meet State requirements and abide by State rules. Thus the American Medical Association (AMA) is able to exert monopoly control of medical care, such as hospitalization, and has a long history of persecuting competitors such as midwives.

But licensing is only the most obvious way in which the State and AMA define medical care. There are many other labyrinthine ways in which the medical establishment partners with authority. In reporting on the AMA’s support of Obamacare, for example, the Wall Street Journal explained last year, “The organization wants to protect a monopoly that the federal government has created for it—a medical coding system administered by the AMA that every health-care professional and hospital must use if they wish to get paid for the services they provide. This monopoly generates income of $70 million to $100 million annually for the AMA. That makes the AMA less an association looking out for doctors and more a special-interest group beholden to Congress and the White House.”

FDA Approved

Legal privilege. All prescription drugs must be approved by the FDA; but, again, the monopoly privilege of being the sole legal drug dealers in society is only the most obvious one granted the pharmaceutical industry and hardly captures the extent of partnership. Moynihan chronicles a less obvious privilege in writing about “one of the biggest healthcare frauds in U.S. history. Pfizer was accused of illegally promoting an anti-arthritis drug for unapproved uses and, so, creating a health risk to users. Pfizer admitted to limited guilt and paid a criminal fine of $1.2 Billion and civil penalties of $1B.” Despite the hefty financial hit, not one executive was held personally responsible; no retribution was sought. The sentencing judge, federal District Court Judge Douglas Woodlock (Massachusetts) commented in his concluding remarks, “This is a case in which no human being, apparently, is going to be held responsible for substantial criminal activity by a corporation.” He notes that Pfizer absorbed the financial hit as a “cost of doing business” and still returned record profits.


Private-public partnerships (PPP). A PPP is a collaboration between government and the private sector in which a venture is funded (in part or in full) by tax dollars and operated through the private sector, or else the private sector raises capital under contract with the government to provide services. Although PPPs are most often associated with infrastructure projects, such as the repair of roads or building of bridges, this sort of ersatz capitalism is rampant within medical research and drug promotion. According to a 2001 study, “hundreds of millions of dollars” have been invested in the United States to promote partnerships around health issues, creating “thousands of alliances, coalitions, consortia and other health partnerships.” That trend has only increased in the ensuing years. Tax-funded research is commonly funneled through nominally private organizations or researchers. Conferences, studies, reports, and such are conducted at taxpayer expense. Arguably, such funding constitutes the greatest barrier to alternative, independent research.

Uncle Sam the Pusherman

Government peddling of pharmaceuticals. It is not merely that private for-profit organizations have used tax dollars to climb aboard the public health bandwagon. The government uses its agencies to create a market base. Just one example is the role of the public schools as a “pusher” of Ritalin—a form of speed more potent than cocaine—to millions of school-age children. Overwhelmingly, it is prescribed to boys who are “unruly” in class. A 2001 report stated, “If Huckleberry Finn and Tom Sawyer were in a school in Massachusetts today, they’d be drugged with Ritalin, according to many psychiatrists and other experts.” As a recent September Huffington Post headline asked, “Do 2.5 Million Children Really Need Ritalin?” Dr. Sanford Newmark continued, “What is going on here? Have millions of our children become so hyperactive and unable to focus that they are incapable of succeeding at school or dealing with the demands of normal life? Or are we creating an illness where there is none, calling normal variations in temperament and personality a ‘disease’ that requires the intervention of long term, and extremely profitable, pharmaceutical medication?”

Monopoly, legal privileges, the rise of PPPs, the use of tax dollars to create disease and eliminate competition, the peddling of pharmaceuticals through government agencies—these issues must be prominent in any productive discussion of the medicalization of everyday life. If the discussion focuses on corporate greed, then the Therapeutic State will have merely entered a new phase.

Antipsychotic drug prescriptions triple in the US

by Setrok Layl on January 15th, 2011
New Scientist – Health

Doctors are prescribing too many expensive antipsychotic drugs, often for conditions where there is little evidence they work, say US researchers.

PRESCRIPTIONS for antipsychotic drugs have more than doubled in the US over the past 15 years, often given for conditions for which there is scant evidence they work.

Antipsychotic drugs are often given for conditions for which there is scant evidence they work.

Expensive antipsychotics were originally approved to treat schizophrenia. They are now also prescribed for conditions including anxiety disorders and dementia, even though the Food and Drug Administration has not approved these off-label uses. The side effects of such drugs can include diabetes, weight gain and an increased risk of heart disease.

Caleb Alexander at the University of Chicago and colleagues analysed the results of a survey of visits to doctors between 1995 and 2008. In the sample population, the prescriptions of antipsychotics went from 6.2 million in 1995 to 16.7 million in 2006 and fell to 14.3 million in 2008. Off-label prescriptions also doubled during this time (Pharmacoepidemiology and Drug Safety, DOI: 10.1002/pds.2082).

Alexander points to ways to combat the trend, such as reducing heavy drug marketing and raising awareness of off-label prescribing.

Design, setting, and measurements

We used nationally representative data from the IMS Health National Disease and Therapeutic Index to describe outpatient antipsychotic use. The primary outcome was the volume of visits where antipsychotics were used for specific indications (treatment visits). We also quantified use without U.S. Food and Drug Administration approval (off-label use) and off-label use with compendium data suggesting an uncertain evidence base.

Results

Antipsychotic use increased from 6.2 million (M) treatment visits (95% CI, 5.4–7.0) in 1995 to 16.7 M visits (15.5–18.2) in 2006, then declined to 14.3 M visits (13.0–15.6) by 2008. A shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). As they declined, typical medications shifted toward use in schizophrenia (30% in 1995 to 48% 2008). In contrast, use of atypical agents expanded for bipolar affective disorder (10 to 34%), remained stable for depression (12 to 14%), and declined for schizophrenia (56 to 23%). Overall, antipsychotic use for indications without FDA approval increased from 4.4 M visits in 1995 to 9.0 M in 2008. The estimated cost associated with off-label use in 2008 was US$6.0 billion.

Conclusions

Atypical use has grown far beyond substitution for the now infrequently used typical agents. Antipsychotics are increasingly used for conditions where FDA approval and associated clinical evidence is less certain. Despite the value of innovation, the benefits of widening atypical antipsychotic use should be weighed against their cost, regulatory status, and incomplete nature of available evidence.

Dirty Big Pharma Tricks That Rip You Off and Risk Your Health for Profit

Even during a recession, pharma is still the nation's third most profitable sector. Here are some of the dirty tricks it employs to stay on top.
By Martha Rosenberg, AlterNet
Posted on December 22, 2010


Even during a two-year recession with people losing their homes and jobs, pharma is still the nation's third most profitable sector. How does it do that? In part by cheating the government, misrepresenting science, bribing doctors, patients and pharmacies, and squeezing the FDA. Other than that, the industry plays completely fair. Pharma has often been criticized for lack of creativity in developing new drugs. But these dirty tricks show its creativity is alive and well when it comes to putting the public at risk just to turn a profit.

1. Astroturf Patients?

Pharma promotes fake patient advocacy groups to lobby for its interests.

These front groups often push the FDA to approve an expensive drug that has acceptable, cheaper alternatives. Or, they'll try to prevent Medicaid from switching to the less pricey drug. One of the largest faux groups, the "grassroots" National Alliance on Mental Illness (NAMI), was investigated by Sen. Charles Grassley for undisclosed pharma links. He found the 10 top NAMI state chapters received $3.84 million from pharma in less than five years, the biggest largesse from Eli Lilly, AstraZeneca and Bristol-Myers Squibb.

How else can you tell an astroturf group? Their Web sites look just like the pharma companies that fund them.

2. Cheating the Government

Pharma is now a top defrauder of the federal government. “Desperate to maintain their high margin of profit in the face of a dwindling number of important new drugs,” pharma illegally promotes unapproved uses of drugs and deliberately overcharges Medicare and Medicaid, says Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. Pharmaceutical companies have been hit with $14.8 billion in wrongdoing settlements in the last five years. But that's still cheaper for Big Pharma than going about things the old-fashioned, legal way. So the fraud continues.

3. Trials and Fibulations

Presiding over clinical trials can make a doctor thousands per patient. But they wouldn't compromise patient safety just to make a buck, would they? Medical College of Georgia psychiatrist Richard Borison and his colleague Bruce Diamond did 13 years ago when they tested Zyprexa, Risperdal and 20 other drugs and ended up in jail. So did Baystate Medical Center's Scott Reuben, who went to prison earlier this year for fraudulent Celebrex, Neurontin and Lyrica trials. And a Tucson facility testing asthma drugs Symbicort, Advair and Singulair doctored data and risked patients' health to net as much as $10,000 per patient, according to a whistleblower and government and court documents. How many other drugs were tested for such fiscal outcomes? Not counting recalled ones, of course.

4. More Trials and Fibulations

Even without fraud, pharma-sponsored studies can deceive. Trials that only determine that a drug is "not worse" than another one or impute safety before real data are available -- as in the case of Vioxx and Avandia's threat of heart attacks -- can skew results. And some research is not meant to be accurate to begin with. The Johnson & Johnson Center for Pediatric Psychopathology Research at Massachusetts General Hospital was founded to "move forward the commercial goals of J.& J." according to unsealed court documents. Its head, Harvard's Joseph Biederman, promised J.& J. a proposed drug trial "will support the safety and effectiveness of risperidone [Risperdal] in this age group," before it was ever conducted. Why leave things up to science?

5. Overseas Adventurism

As pharma increasingly eyes poorer countries for new markets and cheaper manufacturing it also eyes them for cheaper clinical trials. In 1996, 11 Nigerian children died in trials testing Pfizer's not-yet-approved antibiotic Trovan. While Pfizer paid the Nigerian government and state of Kano millions in a settlement, documents released by Wikileaks show that Pfizer tried to extort Nigeria's former attorney general to drop the lawsuits. Trovan was withdrawn from U.S. markets in 2001 for liver toxicity, though "safety signals" may have appeared sooner.

6. Clueless Institutional Review Boards

Institutional review boards, charged with overseeing clinical trials, should catch the unsafe drugs and shady trials. But a Congress and General Accountability Office sting conducted last year on a Colorado review board raises serious doubts. When asked to oversee a study of Adhesiabloc, a product designed to reduce scar tissue after surgery, Coast Independent Review Board said...when do we start? Even though the product did not exist -- nor did its developer or lead researcher!

7. 'Previous Government Experience Desirable'

In the fight against medical fraud, the Justice Department is beginning to file criminal, not just civil, charges against pharma. More employees also are turning whistleblower thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlements, in some cases. But the other side has a big advantage. As long as politicians like former Louisiana Rep. Billy Tauzin, who left government to head the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to commit a career's worth of knowledge, judgment and relationships to sell product, the government is fighting itself.

8. Double Dealing at the Pharmacy

The best thing that ever happened to pharma (after direct-to-consumer advertising) is Pharmacy Benefit Managers (PBMs). Their job is to negotiate the best drugs for their clients, which are heath and pension plans. But they seem far more adept at taking money to push pharma’s top branded drugs, regardless of the cost.

Recently CVS' pharmacy benefit manager, AdvancePCS, sent letters to doctors extolling the benefits of the expensive drug Zyprexa on behalf of drug giant Eli Lilly. Had a generic drug been prescribed over Zyprexa, savings would have been huge.

9. FDA Foreplay

A sneaky way pharma tries to get FDA to approve a drug -- even when the science isn’t there -- is to float the drug to the public. That's where directed marketing comes in. When “patients” (these are often astroturf groups), really want a drug approved, it puts huge pressure on the FDA to be sensitive to the public’s wishes. This tactic famously flopped for Boehringer-Ingelheim this year when it tried to sell a medication for "hypoactive sexual desire disorder" (HSDD) in women (first it had to sell the disease itself). Even though BI debuted its pink Viagra at a medical conference last year and rolled out its elaborate "Sex Brain Body: Make the Connection" Web site with TV personality Lisa Rinna soon after, FDA said no. Seems even though Boehringer-Ingelheim was effective in "raising awareness" about female sexual dysfunction, something else wasn't effective: the drug. And when it came to foreplay, the FDA had a headache.

10. Pharma Service Announcements

Public service announcements are messages for your own good, like, "Do You Know the Seven Warning Signs of Cancer?" But a lot of the awareness messages and warning signs you hear now are not from the government or medical groups, but pharma.

“Voices of Meningitis” ads on mom sites and online TV, for example, look like they are raising awareness of meningitis, but they were actually funded by maker Sanofi Pasteur, which makes a meningitis vaccine.

"Unbranded" advertising appears to have legit origins, like the National Association of School Nurses, which sponsors the Sanofi Pasteur’s meningitis ads. But when TV, radio and web messages push "awareness" of diseases like ADHD, irritable bowel syndrome (IBS), restless legs syndrome (RLS) or excessive sleepiness (ES), be suspicious. Real diseases aren't given initials for quick recall and easy reference. Nor do they come with snappy self-quizzes and pretty patient models. Unbranded messages also pimp the PSA (public service announcement) money that media outlets have for actual public issues.

11. National 'Interests' of Health

The National Institutes of Health are supposed to fund research for the public health with the public's tax dollars. But recently, a researcher who was stripped of his own NIH grant because of his huge financial links to pharma, is ruling on other researchers' grants on NIH committees, reports the Chronicle of Higher Education. The researcher, psychiatrist Charles Nemeroff, was also allowed to keep NIH funds when he moved to the University of Miami after being disqualified from them at Emory University. Clearly, when it comes to conflicts of interest at the top of level of government research, the fox is guarding the henhouse (or pork house).

12. Big Pharma Sends Schools Doctors

Continuing Medical Education (CME) are courses that doctors are required to take to keep their state licenses and stay up-to-date with current practice and treatment guidelines. But many are created by pharma, which covers the cost of the course for the doctor in exchange for unvarnished sales pitches. Worse, many are embarrassingly dumbed down.

A recent "course" offered by Medscape was titled "Quadrivalent HPV Vaccine May Be Effective in Women 24 to 45 Years Old." Participants were told that after taking the course, they would be able to "specify the currently recommended age range" for the vaccine (especially if they could read the title!). Another course manipulates participants to "lobby your legislators" for pharma-related Medicare funding. Congress recently investigated the billion-dollar continuing education industry for illegal marketing -- too bad Congress couldn’t investigate for stupidity.

13. Ghostwriting

Ghostwriting -- papers written by medical marketing writers, with doctors only posing as the authors -- was rampant until 2008 Congressional investigations. But even though it's now prohibited, few journals have retracted ghostwritten articles that sold Vioxx, Fen Phen, Prempro and probably Avandia. Asked about the papers ghostwritten "by" Lila Nachtigall, a professor in the Department of Obstetrics and Gynecology, Deborah Bohren, vice president for public affairs at New York University's Langone Medical Center said, "If we had received a complaint, we would have investigated."

A Congressional investigation doesn't qualify as a complaint?

14. Crooked Books and Slanted Messages

Pharma is often accused of ghostwriting articles that end up in medical journals under doctors' names who had nothing to do with the writing or research. But this month an entire textbook was accused of being funded and approved by pharma. The 1999 textbook, written to help primary care doctors diagnose psychiatric conditions, was funded entirely by GlaxoSmithKline (GSK) -- which makes pills for... psychiatric conditions! Nor were its authors, two prominent psychiatrists, strangers to GSK. Alan Schatzberg is on GSK's speakers bureau and Charles Nemeroff was investigated by Congress for undeclared GSK income. Did the authors write the book themselves or was it ghostwritten by pharma or its marketing company? Does it matter?

15. May I Take Your Order?

Have you ever waited in a doctor's office with a 102-degree fever, only to have pharma reps swinging Vytorin totes see the doctor first, just because they brought free samples or lunch and are dressed for a music video (pharma tends to employ attractive people to hawk their wares)? Until Congressional investigations brought about the Physician Payments Sunshine Act, some doctors in medical centers say they never paid for a meal. Nor did pharma largesse end there. One doctor told AlterNet her entire group was jetted to a Caribbean island courtesy of her Paxil rep. Even medical students were schmoozed until the 62,000-member American Medical Student Association (AMSA) sought to end the pharma practice of gifts and free meals. Now pharma must report what it spends on doctors.

Drugs don't work: professor claims five in six new medicines have 'little benefit' to patients

By Daily Mail Reporter 18th August 2010

Drug companies have been accused of conning the public by hyping up patented medicines with little new to offer while downplaying their potentially harmful side-effects.

A new study estimates that 85 per cent of new drugs offer few if any new benefits while having the potential to cause serious harm due to toxicity or misuse.

The author of the research delivered a damning attack on 'Big Pharma' at a meeting of sociology experts in the US.

Professor Donald Light described the pharmaceutical industry as a 'market for lemons' - one in which the seller knows much more than the buyer about the product, and takes advantage of this fact.

'Sometimes drug companies hide or downplay information about serious side-effects of new drugs and overstate the drugs' benefits,' said Prof Light, a professor of comparative health policy at the University of Medicine and Dentistry in New Jersey, US.

'Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs.

'Doctors may get misleading information and then misinform patients about the risks of a new drug. It's really a two-tier market for lemons.'

He alleged that the pharmaceutical industry owned companies in charge of drug testing and provided 'firewalls' of legal protection behind which information about dangers or lack of effectiveness could be be hidden.

Companies were assisted by the 'relatively low bar' for effectiveness that had to be crossed to get a new drug approved, he claimed.

Prof Light presented his paper, entitled 'Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm' at the American Sociological Association's annual meeting in Atlanta, Georgia.

Over 100,000 Americans Die Each Year from Prescription Drugs, While Pharma Companies Get Rich

Prescription drugs taken as directed kill 100,000 Americans a year.
That's one person every five minutes. How did we get here?

By Daniela Perdomo, AlterNet
June 25, 2010

How many people do you know who regularly use a prescription medication? If your social group is like most Americans', the answer is most. Sixty-five percent of the country takes a prescription drug these days. In 2005 alone, we spent $250 billion on them.

I recently caught up with Melody Petersen, author of Our Daily Meds, an in-depth look at the pharmaceutical companies that have taken the reins of our faltering health care system by cleverly hawking every kind of drug imaginable. We discussed how this powerful industry has our health in its hands.

Daniela Perdomo: Your book includes some staggering stats. For example, 100,000 Americans die each year from prescription drugs — that’s 270 per day, or, as you put it, more than twice as many who are killed in car accidents each day. Could you elaborate on this? Are these people abusing their prescription drugs or is this a sign of prescription meds gone bad? 

Melody Petersen: The study estimating that 100,000 Americans die each year from their prescriptions looked only at deaths from known side effects. That is, those deaths didn’t happen because the doctor made a mistake and prescribed the wrong drug, or the pharmacist made a mistake in filling the prescription, or the patient accidentally took too much. Unfortunately, thousands of patients die from such mistakes too, but this study looked only at deaths where our present medical system wouldn’t fault anyone. Tens of thousands of people are dying every year from drugs they took just as the doctor directed. This shows you how dangerous medications are.

DP: You write about a growing market for drugs for children. You say we know little about the long-term effects of prescription meds on kids. Let’s talk particularly about depression medications and ADHD meds, which seem to be what kids are mostly prescribed. 

MP: In recent years, sales of drugs for children have been the industry’s fastest growing business. Doctors now prescribe pills to children for all kinds of conditions — from high cholesterol to anxiety. The market for ADHD drugs has long been a big opportunity for the industry. More recently, the companies have had their sales reps urge doctors to prescribe antidepressants, antipsychotics and other psychiatric meds to children. The result: our kids take more of those medicines than children in other countries. For example, a study last year found that American children take three times more attention deficit medications and antidepressants than children in Europe.

DP: Could you tell me how the prescription med industry is in bed with doctors?
MP: The industry spends hundreds of millions of dollars on physicians every year. In one survey, 9 out of 10 doctors said they had recently taken something of value from the drug industry. And some of those doctors take hundreds of thousands of dollars each year from the industry. The drug companies pay doctors to be their so-called consultants. They also pay them to sit on corporate advisory boards and to give lectures to other doctors. They pay for up to 80 percent of the continuing medical education that doctors need to maintain their licenses. If you ask a doctor if this is a problem, they will more than likely tell you no. But the studies show that even a small gift will sway doctors to write a prescription for a certain drug. The truth is that doctors are no longer independent gatekeepers who keep us safe from drugs we don’t need. Far too many of them are financially tied to the industry. They are writing the prescriptions that their financial backers want them to write.

DP: We are the only developed country that doesn't control prescription drug prices. Could you tell me what that means, practically, for consumers?
MP: It means that the drug companies can charge whatever they want to — even for drugs that don’t work very well. One drug costs $400,000 a year. Some cancer drugs now cost $50,000, even though on average, they give the patient just a few weeks extra to live. It’s clear that the drugs aren’t worth these extreme prices, but the companies are taking advantage of patients who are desperate for a cure. The industry’s unlimited hikes in prices have helped make health insurance unaffordable. This is also why wages of American workers have stagnated. When health premiums rise, employers must get the extra money from somewhere, and employee raises are one of the first things to go.

DP: You write about how companies are more interested in developing 'lifestyle drugs for rich Americans' rather than discovering cures for diseases that affect the majority of the world, like malaria. How many cholesterol drugs do we need? Sex drive meds? Hair loss meds?
MP: The answer is that we really don’t need many of those kinds of drugs, those lifestyle drugs that don’t save or lengthen lives. But the drug companies have discovered there are billions of dollars to be made by selling pills to Americans who worry about getting old, but are otherwise healthy. It’s so easy to fall for the marketers’ claim that a little pill will enhance our lives and keep us young forever.

DP: Could you tell me about drugs that are developed for one use but used for another. How often does this happen?
MP: It is a common sales tactic in the industry to have sales reps push doctors to prescribe a drug for many uses and patient conditions. The drug companies do this even though it is illegal to promote a drug for anything other than the condition the FDA has approved it for. I detail in my book how a lackluster drug for epilepsy – a drug called Neurontin -- was sold by a company for just about any condition that affects the brain. The company’s sales representatives pushed doctors to prescribe Neurontin for children with attention problems, for adults with mania, for just about anyone with restless legs. They did this even though they had no scientific evidence that it helped people with these conditions. This is a very dangerous corporate fraud.

DP: How often are ailments created simply to fit a drug already created?
MP: The industry has proven that it is not beyond creating new diseases when it wants to expand the use of a drug. For example, I wrote in my book about how the company Pharmacia created the disease of overactive bladder to expand sales of a drug for incontinence. We don’t know how often this is done because few companies are willing to tell the public how their marketers work behind the scenes.   

DP: What do we prescribe drugs for that other countries don’t? In other words, what ailments do Americans suffer from that other nations don’t?
MP: The drug companies have made Americans believe that almost anything should be treated with a pill. Women can ask their doctors for a drug that will diminish their facial hair. Parents can ask for a stimulant to keep their children calm and focused. Even people who are shy are now told they have a disease that needs to be medicated. This is far less prevalent in other countries because the drug companies don’t have as much power elsewhere. The U.S. and New Zealand are the only two developed countries in the world that allow the drug companies to aggressively advertise prescription drugs to consumers.

DP: Why do we rush to prescribe? Have we always been this way or was there a shift at some point?
MP: The prescriptions are driven by the promotional efforts of the industry. Today, the companies start promoting a drug years before it even goes to the FDA for approval. Some drugs have promotional campaigns funded by more than a billion dollars. It was around 1980 when the big drug companies learned that they could make far more profit by focusing their efforts on marketing rather than on the truly hard work of scientific research and finding new drugs.

DP: American life expectancy is low compared to other developed nations. What are they doing right? We’re not the only ones with prescription drug companies within our borders.
MP: In America, if you’re lucky enough to have health insurance, you can easily get too much medicine, too much health care. Many Americans don’t understand that all of health care has risks and that too much of it can actually shorten your life. Is this one of the reasons why we’re falling fast in the world rankings on life expectancy? No one knows for sure. But it’s obvious that all that money we spend on prescriptions and doctors is not giving us an advantage.

DP: From a consumer/patient standpoint, are certain drug manufacturers better than others?
MP: No. There is not an ethically minded shining star. All the companies operate in a similar way. Fraud is rampant in this industry because there is so much money involved.

DP: How will the health care bill affect prescription drug use and the med industry?

MP: The drug companies and their lobbyists won big under the new health care law. The companies will get millions of new customers. At the same time, Congress agreed with the industry’s lobbyists that there should be no limits on how much they can charge for medicines. We needed to make health insurance available to all Americans, but there should have been stronger cost controls and promotional limits in the law. Now, even more people will be at risk of getting dangerous and expensive drugs that they don’t need.

DP: What do you make of theories that someday very soon we’ll all be on smart drugs. Realistic? Already here?
MP: I recently spoke to a college student who told me he used Adderall, a drug for ADHD, to enhance his studies. He didn’t have a prescription for the drug. He got the pills from friends. He knew this was dangerous and illegal, but he did it anyway. People no longer understand that every drug comes with risks. Adderall, for example, comes with a label warning that using it without a prescription can lead to addiction, and in rare cases, death. The marketers have made us believe that we can do just about anything with the help of a pill.

DP: What is the biggest issue relating to prescription drugs that the mainstream media misses?
MP: Overall, the biggest problem is that the news media is not objective when reporting on medicines. Much of the news coverage on prescription drugs exaggerates their potential benefits and glosses over their risks. Many news stories about new drugs don’t even mention the side effects. People are getting distorted information on prescription drugs. Many of these news stories are little more than press releases that come straight out of the drug companies’ marketing departments.

Overly Medicated by Prescription Drugs

Video link

The Psychiatric Drugging of Infants and Toddlers

An American Phenomenon
By EVELYN PRINGLE

The United States has become the psychiatric drugging capital of the world for kids with children being medicated at a younger and younger age. Medicaid records in some states show infants less than a year old on drugs for mental disorders.

The use of powerful antipsychotics with privately insured children, aged 2 through 5 in the US, doubled between 1999 and 2007, according to a study of data on more than one million children with private health insurance in the January, 2010, "Journal of the American Academy of Child & Adolescent Psychiatry."

The number of children in this age group diagnosed with bipolar disorder also doubled over the last decade, Reuters reported.

Of antipsychotic-treated children in the 2007 study sample, the most common diagnoses were pervasive developmental disorder or mental retardation (28.2%), ADHD (23.7%), and disruptive behavior disorder (12.9%).

The study reported that fewer than half of drug treated children received a mental health assessment (40.8%), a psychotherapy visit (41.4%), or a visit with a psychiatrist (42.6%) during the year of antipsychotic use.

"Antipsychotics, which are being widely and irresponsibly prescribed for American children--mostly as chemical restraints--are shown to be causing irreparable harm," warned Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a February 26, 2010 InfoMail.

"These drugs have measurable severe hazardous effects on vital biological systems, including: cardiovascular adverse effects that result in shortening lives; metabolic adverse effects that induce diabetes and the metabolic syndrome," she wrote. "Long-term use of antipsychotics has been shown to result in metabolic syndrome in 40% to 50% of patients."

The lead researcher on the study above, Columbia University psychiatry professor Mark Olfson, told Reuters that about 1.5% of all privately insured children between the ages of 2 and 5, or one in 70, received some type of psychiatric drug in 2007, be it an antipsychotic, a mood stabilizer, a stimulant or an antidepressant.

Psychiatric drugs bathe the brains of growing children with agents that threaten the normal development of the brain, according to Dr Peter Breggin, founder of the International Center for the Study of Psychiatry and Psychology (ICSPP), and author of about 20 books, including "Medication Madness."

The drugs themselves are causing severe disorders in millions of children in the US, he warns. "Substances like antidepressants, stimulants, mood stabilizers, and antipsychotic drugs cause severe, and potentially permanent, biochemical imbalances."

American Phenomenon

A number of presentations at the annual meeting of the American Psychiatric Association in May 2009, addressed the diagnosis of bipolar disorder, including one titled, "Pediatric Bipolar Disorder: A Critical Look at an American Phenomenon," at which Dr Peter Parry, a consultant child & adolescent psychiatrist, and senior lecturer at Flinders University in Australia, presented a survey on, "Australian and New Zealand's Child and Adolescent Psychiatrists' Views on Bipolar Disorder Prevalence and on Rates of Pediatric Bipolar Disorder in the USA."

Dr Parry and his colleagues conducted a survey of child and adolescent psychiatrists in Australia and New Zealand. Of the 199 psychiatrists who responded to the survey, 90.5% thought pediatric bipolar disorder was overdiagnosed in the US.

In an October 1, 2009 article titled, "Medicating Our Children," Dr Parry reports that since "the mid-1990s in the USA, some researchers have claimed that Paediatric Bipolar Disorder (PBD) frequently starts prior to puberty."

One of PBD's main proponents, Harvard University's Professor Joseph Biederman, stating onset "is squarely in the preschooler age group," he notes.

Parry explains that "PBD has been created by moving the diagnostic goalposts away from traditional concepts of bipolar disorder."

"In children," he says, "episodes were redefined to last hours instead of days or weeks and, instead of manic elation, severe anger in children sufficed as mania."

"Unlike diagnoses like ADHD or depression, or simply accepting a child has serious emotional and behavioural problems in reaction to various stressors, PBD implies a lifelong severe mental illness requiring of strong psychiatric medication," Parry warns.

"In the USA," he says, "the public is furthermore exposed to direct pharmaceutical advertising that can feed the natural desire parents of distressed and aggressive children have for a quick solution by suggesting a simple medication fix."

"The medicating of America's children has become intensely controversial, highlighted by the tragic case of Rebecca Riley, a four-year-old Boston girl diagnosed at 28 months old with ADHD and PBD," he points out.

On April 7, 2009, the author of the book, "Shyness: How Normal Behavior Became a Sickness," Christopher Lane, featured an interview on his Psychology Today blog, "Side Effects," with journalist, Philip Dawdy, the creator of the popular website, Furious Seasons, and discussed the rising number of children being diagnosed with bipolar disorder.

"As for bipolar disorder in kids (meaning pre-teens and younger), it's simply not an issue in the rest of the world," Dawdy told Lane. "The bipolar child is a purely American phenomenon."

"The pharma companies and the Harvard crew worked hand-in-hand to bring America a generation of ADHD kids and bipolar children, and their profound influence can be seen in the millions of children and teens who now carry lifetime diagnoses and take gobs of psychotropic drugs each day, often to their detriment," he advised.

Lane asked for Dawdy's opinion on a recent report in the St Petersburg Times that found 23 infants less than one-year-old had been prescribed antipsychotics in Florida in 2007, as well as the drug overdose death of 4-year-old Rebecca Riley in Massachusetts. "How is it possible for psychiatrists to continue prescribing to infants in such numbers without more oversight?" Lane asked.

"What's gone on with antipsychotics prescribed to infants and toddlers is simply inexplicable to me," Dawdy said. "The drugs are known to cause huge problems in adults, so why the heck would a doctor give them to little kids, especially infants? It boggles my small mind."

"I'm no fan of bans or restrictions," he told Lane, "but this does strike me as a situation where there needs to be a serious rethinking of what we are doing—and maybe there should be a ban on the use of these drugs in kids under, say, 6 years of age."

An October 2007 report by the University of South Florida found the most common diagnosis for antipsychotic use with children in Florida’s Medicaid program, between July and December 2005, was ADHD. Roughly 54%, or 1,372 cases, involved prescriptions for children five and under and the total number of antipsychotic users in this young age group was 2,549, with all disorders combined, according to the report.

Increased Prescribing to Poor Children

Federally funded research published online in December, 2009, revealed that children covered by Medicaid were prescribed antipsychotics at a rate four time higher than children with private insurance. The data showed that more than 4% of children in Medicaid fee-for-service programs received antipsychotics, compared to less than 1% of privately insured youth. The study found Medicaid kids were more likely to receive antipsychotics for unapproved uses such as ADHD and conduct disorders than privately insured children.

The researchers examined records for children in seven states for the years 2001 and 2004, chosen as representative of the US Medicaid population. But more recent data through 2007 indicates that the disparity has remained, said Stephen Crystal, a Rutgers professor who led the study, according to the December 11, 2009, New York Times.

Antipsychotics were the top selling class of drugs in both 2008 and 2009. With sales of $14.6 billion in 2009, they brought in more than the $13.6 billion earned by both heart burn and cholesterol medications. Antidepressants ranked fourth with sales of $9.9 billion, according to data by IMS Health. In 2008, the drug makers took in $11.3 billion from antiseizure drugs and $4.8 billion from ADHD drugs.

In a new book titled, "Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America," Robert Whitaker reports that the number of children on government disability rolls due to severe mental illness has increased more than 35-fold since 1987.

The book explores the question of whether the epidemic rise in people disabled by mental illness, among all age groups in the US over the past 20 years, could have been fueled by a drug-based paradigm of care.

It also explores what is happening to children over the long-term who are placed on psychiatric drugs. "Once again, science tells a very clear story, and, as you might imagine, it is one that — when you think of the millions of children so affected — makes you want to weep," Whitaker stated in a March 26, 2010, notice for the book's release on the Beyond Meds Website.

Experimental and Controversial Vaccines in Public Schools

Pharma Planning to Dump Experimental and Controversial Vaccines in Public Schools
03-29-2010

The golden calf of public health was smashed in this recent flu season as many in the United States outright rejected the H1N1 vaccine. Pharmaceutical companies are now holding the bag, as millions of doses of the vaccine are rotting on shelves or being discarded as hazardous waste. Or are they? The manufacturer may find it more cost effective to dump them into the arms of our public school systems.

Parents would revolt if they knew that the pharmaceutical industry, the Department of Health and Human Services, and Centers for Disease Control have allocated millions of dollars in funding to establish vaccine clinics in the public schools. Pumping children with experimental vaccines in public school is about to be pursued as a matter of policy.

Denver Public Schools the Target

Recently, a news article (http://www.denverpost.com/commented...) in the Denver Post highlighted two grants issued by the Centers for Disease Control totaling $1.6 million dollars to vaccinate students attending Denver Public Schools (http://communications.dpsk12.org/an...).

One grant (http://communications.dpsk12.org/an...) funds an effort to establish a sustainable school-based vaccination program utilizing the yearly influenza and experimental H1N1 vaccine. The hope is to create a partnership between public health (Denver Health), school personnel (Denver Public Schools), and an entity (Kaiser Permanente) that would bill third party payers.

The second grant (http://www.cdc.gov/od/pgo/funding/I...) provides cash for vaccinating children with the newly approved diphtheria toxoid and acellular pertussis vaccine (Tdap), meningococcal conjugate vaccine (MCV4), and human papillomavirus vaccine (HPV). The new vaccines for adolescents are among the most expensive vaccines (http://www.cdc.gov/vaccines/program...) recommended today for any age group.

Lead investigator of Denver In-School Immunization Project, Dr. Judith Shlay, of Denver Health, readily admits that if all goes well, plans are in place to implement school-base vaccine clinics (http://www.youtube.com/watch?v=PHji... ) nation-wide (a high level overview of this plan (http://www.nasbhc.org/site/c.jsJPKW...) was presented to the National Assembly on School-Based Health Care by Dr. Shlay).

School Based Health Clinics As the Conduit

The Denver In-School Immunization Project (http://denverhealth.org/portal/Serv...) has long been in the works. It was paved in the late 1970s and early 1980s by incrementally creating School-Based Health Clinics (SCHC). In 1978, The Robert Wood Johnson Foundation (RWJF), a non-profit organization funded by the Pharmaceutical Company, Johnson and Johnson (http://www.sec.gov/Archives/edgar/d...), contributed $2.3 million dollars to the state of Colorado, (http://www.rwjf.org/reports/grr/032...) making SBHCs a reality.

Illnesses such as ADD/ADHD, Cervical Cancer, diabetes, asthma, obesity, and learning disabilities were of little consequence in the '70s. However, these disabling syndromes and the medications aimed at treating them have all reached epidemic proportions and astronomically profitable sales.

In the past, parents have discovered challenging a school-based medical model can be extremely dangerous. In September, 2000, Ms. Patti Johnson, a former Colorado State education board member, testified before Federal Congress (http://www.politicalwatchdog.com/ps...) concerning Selective Serotonin Reuptake Inhibitors (SSRIs). In the 1990s, the much-hyped drug, Ritalin, was maneuvered into public schools to address the growing epidemic of hyperactivity. Mrs. Johnson testimony was prophetic and foreshadowed a future scenario where parents could be charged with medical neglect if they refused to medicate their child per the school's request.

Vaccines for All School Children is the Goal

If School Based Health Clinics are being used as the conduit to vaccinate children, the federally-funded Vaccines For Children (VFC) (http://www.cdc.gov/vaccines/program...) program and third party insurance coverage provide the finances. According to the grant approved by the CDC, the VFC program would provide "free" vaccines to an estimated forty percent of children in the United States who are not covered by third party insurance plans.

"The goal is for this (Denver In-School Immunization Project) to be a sustainable program that can immunize all children in the schools regardless of their insurance. And we need to see at the end of the day, when all the dust settles at the end of this school year, whether the amount that was reimbursed for all these different insurance companies, adds up to the amount of time and effort it took to actually have the clinic." (Emphasis added)

Dr. Matthew Daley
Evaluator of the Denver In-School Immunization Project
Kaiser Permanente
Colorado Public Radio Interview
February 17th, 2010
(http://www.kcfr.org/index.php?optio...)

Put into context, the implications of the Denver In-School Immunization Project are enormous. We are speaking of a captured market for vaccine manufacturers (guaranteed purchase of vaccines), insurance companies (guaranteed rise in premiums), and government funding (VFC) all footed by taxpayer dollars. The total price per vaccinated adolescent in the private sector is approximately $500 (http://www.elsevier.com/wps/find/au...). That's a lot of cash.

What Does Pharma Know?

Dr. Matthew Daley is very aware that a paltry 1/3rd of adolescents receive their yearly influenza vaccine, for example. In a semi-recent presentation, (http://www.preventinfluenza.org/NIV...) Dr. Daley shows obtaining parental consent is a barrier to mass vaccination in a school setting. Furthermore, the presentation suggests improved financial incentives for providing influenza vaccinations. Dr. Daley must be sharing his notes with RAND Corporation because it is almost the exact message RAND pitched to the pharmaceutical giant, Sanofi Pasteur.

In 2007, a study performed by RAND Corporation, funded by Sanofi Pasteur, investigated the most efficient way to vaccinate (http://www.rand.org/pubs/documented...) low-income adolescents. Nicole Lurie,(http://www.opensecrets.org/revolvin...) one authors of the white paper, is now an adviser to Kathleen Sebelius, the Secretary of Human Health Services (HHS). Mrs. Lurie has a long history of traversing the revolving door between private industry, government duties, and academic appointments (there is no difference from the former head of the CDC, Julie Gerberding, (http://vactruth.com/2010/01/04/juli...) becoming President of Merck Pharmaceuticals Vaccine Division).

RAND's report identifies barriers that would obstruct "alternative vaccination campaigns," otherwise known as "in-school vaccination programs." The list of legal issues includes parental consent laws, absence of a reliable medical home (where an adolescent receives medical treatment such as a doctor's office), and access to vaccine registration information.

Your current ability to refuse vaccines for your children, which is protected by most state laws, is considered a barrier to Pharmaceutical Interests.

*As a side note, many states are taking steps to move parents out of the way and allow public officials the right to vaccinate children, without parental consent. By example, legislation is being considered in New York that would give absolute authority to health professionals to vaccinate children under 18 years old without the parental consent. Another bill in New York (http://vactruth.com/2010/02/12/new-...) seeks to mandate the controversial HPV vaccine (Gardasil) for school entry.

With Public Relations at the foreground, The RAND paper further recommends that Sanofi Pasteur create "Vaccine Champions" or "Registration Champions." Vaccine champions are "ardent supporters of a cause … They can bring about change by educating those around them and spurring others into action through local events, meetings, or publications." Coincidentally, non-profit organizations such as The Immunization Partnership are following lockstep with the RAND Corporation's group-think. It also has "Immunization Champions." (http://www.immunizeusa.org/iz-champ...)

If vaccines are mandated for public school attendance, and most likely they will be, you can bet that it won't matter whether the vaccine is experimental or not. With rising awareness of the chronic effects of mass vaccination, public skepticism and outcries will likely be countered with fear mongering (http://www.scribd.com/doc/19212191/...) by fanatical vaccine advocates and lobbying groups funded by Big Pharma interests. The only real way to protect the safety of our children is to fiercely safeguard state exemption laws that uphold parents' freedom to choose whether to vaccinate or not.

Yet, by blending society's Federal Educational Framework with a superficial medical model, vaccine proponents have a road map to overcome any damaging future resistance to experimental vaccines.