Posts Tagged ‘pharma’

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Big Pharma’s Scam: U.S. Drug companies rig medication studies

Tuesday, December 6th, 2011

December 6, 2011  – Note from CCHR:  We created the psychiatric drug side effects database due to the misleading studies about psychiatric drug safety and efficacy being put out by the psychiatric/pharmaceutical industry.  For facts (instead of pharma funded studies)  from international drug regulatory agencies visit the psychiatric drug side effects database – click here

Many of these pharmaceutical studies were sponsored by the drug manufacturers; sponsors who the report states "may promote the use of outcomes that are most likely to indicate favourable results for their products."

Mercola.com—New research has revealed just how misleading and questionable the results of medication studies cited in top medical journals actually are — adding to an already sizeable mountain of data on mainstream medical manipulation.

Pharmaceutical and vaccine makers are continually found to be sponsoring the very institution performing the study on the effectiveness of their product.

Such is the case with a recent inquiry that examined the trustworthiness of top drug trials.

Investigators from UCLA and Harvard recently analyzed the randomized drug trials from six prestigious journals, reaching a conclusion that brings into question the overall credibility of many top medication studies and those who perform them.

  •  Many medication studies published in leading journals have been found to be sponsored by drug manufacturers and include deceptive statistical reporting and wording.

 

  • The flu vaccine is a perfect example of medical manipulation, with research concluding the effectiveness of the shots to be as low as one percent. In addition, the “gold standard” for scientific reviews has repeatedly found that there is little to no evidence backing flu vaccines as an effective flu prevention strategy. Despite this, they are still pushed by mainstream health officials
  • The reason why much of the population believes in mainstream medicine can be traced back to the PR campaigns of Edward Bernays, the so-called father of spin. Bernays focused on ‘conditioning’ consumers into believing many mainstream medical fallacies.

The investigative team found that many of these pharmaceutical studies were sponsored by the drug manufacturers; sponsors who the report states “may promote the use of outcomes that are most likely to indicate favourable results for their products.”

In fact many of these studies have been found to utilize different statistical techniques in order to establish the supposed safety of many medications that may actually be harmful to you.

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For international drug regulatory warnings on documented side effects/risks of psychiatric drugs click here

 

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NY Times—Payments to Doctors by Pharma Raise Issues of Conflicts, CCHR warns of tainted mental health policies

Friday, November 25th, 2011

New York Times November 24, 2011

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

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

By EMILY RAMSHAW and RYAN MURPHY
Published: November 24, 2011

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Would Tom Sawyer and Huck Finn be diagnosed mentally ill and drugged?

Thursday, September 1st, 2011

Natural News – September 1, 2011

by Monica G. Young

Imagine if the beloved young characters in Mark Twain’s classic, “The Adventures of Tom Sawyer,” lived today. Based on current psychiatric criteria, Tom and Huck could be designated mentally ill and prescribed mind-altering drugs. Quiet, listless and numb, their legendary adventures would be over.

Describing a day in school, Twain wrote: “The harder Tom tried to fasten his mind on his book, the more his ideas wandered.” His “heart ached to be free, or else to have something of interest to do to pass the dreary time.” That’s a text book so-called symptom of ADHD (attention deficit hyperactivity disorder). A teacher today could refer him to a psychiatrist who would dope him with stimulants. Yet like any typical boy, Tom had no trouble focusing attention on something he found interesting – like finding a hidden treasure.

Tom’s friend Huckleberry might fare worse. An avowed non-conformist, a psychiatric checklist could tag him with ODD – oppositional defiant disorder. And having run away from an abusive father, Huck would land in the hands of Child Protective Services who would sedate him on psychoactive drugs subsidized by government funds.

Although no brain scan, blood test or x-ray had been done, the psych doctors would claim the boys’ mental illness stemmed from a neurobiological disorder involving chemical imbalances in the brain, probably hereditary.

Tom and Huck would likely experience insomnia, stomach aches, high blood pressure, stunted growth or some other “side” effects, and more drugs would be added to treat these. They would start feeling despondent and have mood swings, leading to probable depression or bipolar disorder diagnoses and more drug cocktails. The once spirited youths might end up as life-long pharmaceutical junkies.

Psychiatry revealed as an industry of fakers

Recently Harvard-trained psychiatrist Daniel Carlat exposed psychiatry as essentially a field of imposters. His book, “Unhinged; the Trouble with Psychiatry – a Doctor’s Revelations about a Profession in Crisis,” reads much like a confession – and rightly so.

Despite all their years in medical school, psychiatrists do not use any medical tests in diagnosing. Instead their labels are entirely subjective, opinionated and based upon a manual of disorders voted into existence by a psychiatric committee.

Yet these “experts” have transformed boyhood into “ADHD,” shyness into “social anxiety disorder” and menstrual discomfort into “premenstrual dysphoric disorder.” Some toddlers are labeled before given a chance to learn to talk.

Carlat states, “Psychiatrists have cordoned off the most painful versions of normal life, defined them as syndromes, and have given them medical-sounding names.” Yes, there are people who suffer from severe mental disturbances, but he says it’s “an illusion that we understand our patients when all we are doing is assigning them labels.”

Where is the science in all this? He writes, “While the scientific literature contains thousands of papers proposing neurobiological theories to explain PTSD [post traumatic stress disorder], depression, bipolar disorder, schizophrenia, and other psychiatric disorders, these theories remain unproven…” And he confides, “the shocking truth is that psychiatry has yet to develop a convincing explanation for the pathophysiology of any illness at all.”

In regards the chemical imbalance rant, Carlat says this is nothing more than a “convenient myth” so psychiatrists can appear authoritative and avoid looking ignorant with their patients.

This is an industry riveted to drugs, drugs and more drugs. Forget really listening to and understanding a patient’s troubles in life. Now it’s all about lucrative fifteen-minute monthly med checks – about as personal as Wendy’s drive-through.

Pharmaceutical industry influence has vast bearing on what medications psychiatrists use and how often. Carlat admits, “We have been seduced by the constant encouragement from drug companies to prescribe more medications…” Such seduction ranges from a drug rep bringing a doctor his favorite drink from Starbucks, to companies paying him up to a million or more to be their marketing mouthpiece.

Psycho-Pharma’s drug obsession diverts society’s attention off non-harmful solutions like teaching life skills, improving education, better nutrition and exercise, and addressing environmental factors.

In short, for all their diplomas, chic offices, puffed-up terminology and high fees, this is a field where greed and deception replace ethics and scientific methodology. Fortunately some like Daniel Carlat are blowing the whistle.

Most unforgivable is the dispensing of labels and drugs to millions of children. The leading gurus of this campaign have been psychiatrists deep in the pockets of Big Pharma, such as the exalted Dr. Joseph Biederman – flanked by an army of Pharma-paid “advocacy” groups.

Perhaps we should ourselves vote on labels to categorize such mentally-depraved individuals, such as conscience deficit hyper-lying disorder (CDHD) or better yet, false representation and underhandedness disorder (FRAUD).

Sources for this article include:

“The book, “Unhinged; the Trouble with Psychiatry – a Doctor’s Revelations about a Profession in Crisis,” by Daniel J. Carlat, M.D.

http://speedupsitstill.com/dangerou…

http://www.thefix.com/content/jj-su…

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Are You Taking Pills You Don’t Need? Here Are Some Reasons Why

Thursday, July 21st, 2011

OpEdNews – July 21, 2011
by Martha Rosenberg

Most people blame direct-to-consumer advertising, especially on TV, for elevating everyday anxiety to depression, depression to bipolar disorder, childhood behavior problems to psychiatric illnesses, lack of sleep to excessive sleepiness, migraines to epilepsy drug deficiencies and old age to hormone deficiencya.

But ghostwriting also helps the national malaise of people suffering from and treating diseases that didn’t even exist before and ballooning government and private health plans costs.

There are 200 US medical education and communication companies (MECCs) who ghostwrite medical journal articles for pharma for $20,000 to $40,000 per article. Companies like Complete Healthcare Communications (CHC) whose phalanx of 50 medical writers, editors and medical directors promise a “84.5 percent acceptance rate for first-time manuscript submissions.”

Ghostwriting was behind the blockbuster Vioxx, withdrawn in 2004 for doubling the risk of heart attacks. “Merck designed the trial, paid for the trial, ran the trial,” Dr. Jeffrey R. Lisse told the New York Times about a Vioxx study he authored in the Annals of Internal Medicine that left out three cardiac deaths. Oops. “Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck, and then it was sent to me for editing.”

Medical journals themselves can make $450,000 off one such ghostwritten article, because pharma orders reprints which reps disseminate as sales pieces (“look, Doc, it says RIGHT HERE”).

Click image to watch Psychiatric Drug Side Effects Video

In 2006, the editor-in-chief of the Journal of the American Medical Association (JAMA) Dr. Catherine DeAngelis had to apologize for a pharma-tainted article that defended the use of antidepressants during pregnancy and an article linking migraines to coronary risks in women. The doctor authors, it turned out, were getting money from antidepressant and heart medication manufacturers.

But ten months later, JAMA ran a study “designed jointly by the non-Merck investigators and Merck employees” and “supported by contracts with Merck and Co” that extolled the virtues of Fosamax, a Merck bone drug. Three Merck authors on the study disclosed they potentially owned Merck “stock and/or stock options” and the article’s 11 other authors disclosed 40 research grants, consultancies and other financial relationships with drug companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth (now Pfizer) Novartis, Procter & Gamble and Merck. Since then, the FDA has issued several warnings about Fosamax and other bone drugs.

In 2007, the AMA itself was criticized for playing both sides of the enterprise street and making $50 million a year selling the names, office addresses and practice types of its members to data miners. The AMA’s defense? Doctors could “opt out” of the privacy-invading program if they wanted to.

And then there are pharma’s “unbranded” campaigns designed to look like real public health messages or communications from grassroots groups. Who can forget PR firm Cohn and Wolfe’s faux grassroots group Freedom From Fear to sell Paxil, a pill now linked to birth defects? And the Wyeth (Pfizer) campaign, The Change You Deserve which said, whoever you are, you have depression and need Effexor?   Now, a new unbranded pharma campaign, Depression Is Real, running on radio stations, compares depression to cancer because it kills and diabetes because it doesn’t go away. Kind of like pharma’s huckstering.

http://www.opednews.com/articles/Are-You-Taking-Pills-You-D-by-Martha-Rosenberg-110721-870.html?show=votes

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Antidepressant Nation

Thursday, July 14th, 2011

Truthdig – July 14, 2011

10 percent of Americans over age six now take antidepressants

A serious conversation is under way in the United States on the subject of psychiatric drugs. The debate consists of three fundamental issues: first, whether antidepressants actually treat depression; second, the vast, growing body of evidence that psychotropic medications alter the brain permanently; and third, the pharmaceutical industry’s continuing, decades-old corruption of American psychiatrists, many of whom have been made by drug companies’ shenanigans into little more than handsomely paid industry shills.

A careful questioning of these issues written by the spectacularly decorated Harvard Medical School lecturer Dr. Marcia Angell appeared as a two-part essay published earlier this summer in The New York Review of Books. In addition to holding a medical degree from Boston University School of Medicine and undergraduate diplomas in both chemistry and mathematics, Angell is a Fulbright Scholar, a board-certified pathologist, author of two books, a member of numerous professional health care associations and a retired 20-year staffer at the New England Journal of Medicine, which she ultimately left as editor-in-chief.

The recent publication of three books, each of which takes up one of the issues raised above, provided the occasion for Angell’s essay. In it, she argues convincingly that antidepressants are not known to do what drug companies and many psychiatrists say they do. It is this claim that drew the attention of practicing psychiatrist and Brown University professor Dr. Peter D. Kramer, who in a New York Times commentary published last Sunday questioned some but not all of what Dr. Angell wrote.

Both articles deserve to be read, but there is a crucial difference between them. While Kramer points to much data that must be taken seriously, his wandering defense of the utility of antidepressants does not undo the diligent, methodical inquiry one would expect from someone with Angell’s credentials—and which she delivers. Otherwise, he too is a critic of Big Pharma’s shady dealings. Kramer nods with genuine concern toward the dangers associated with the prolonged use of psychotropics and, in his conclusion, expresses support for treatment via effective alternatives. Both professionals agree that serious research needs to be done to understand exactly what these drugs are doing. —ARK

Marcia Angell in The New York Review of Books:

Nowadays treatment by medical doctors nearly always means psychoactive drugs, that is, drugs that affect the mental state. In fact, most psychiatrists treat only with drugs, and refer patients to psychologists or social workers if they believe psychotherapy is also warranted. The shift from “talk therapy” to drugs as the dominant mode of treatment coincides with the emergence over the past four decades of the theory that mental illness is caused primarily by chemical imbalances in the brain that can be corrected by specific drugs. That theory became broadly accepted, by the media and the public as well as by the medical profession, after Prozac came to market in 1987 and was intensively promoted as a corrective for a deficiency of serotonin in the brain. The number of people treated for depression tripled in the following ten years, and about 10 percent of Americans over age six now take antidepressants. The increased use of drugs to treat psychosis is even more dramatic. The new generation of antipsychotics, such as Risperdal, Zyprexa, and Seroquel, has replaced cholesterol-lowering agents as the top-selling class of drugs in the US.

Read Part 1: The Epidemic of Mental Illness: Why?

Read Part 2: The Illusions of Psychiatry

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Bad Side-Effects Ahead For Pharma?

Thursday, June 30th, 2011

Forbes – June 30, 2011

by Martin Fridson

In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.

These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder.  The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.

The New York Review of Books‘ recent two-part article (1)  by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks.  (All statistics and quotations herein are drawn from Dr. Angell’s article.)

It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so.  The profits in psychoactive drugs, however, make it tempting to flout the law.  In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.

Seeing that pharmaceutical marketing executives are evidently undeterred by the law, Dr. Angell, a senior lecturer in social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, advocates a prohibition on prescribing psychoactive drugs off-label.

A ban would cut into a major growth area for pharmaceutical companies.

This growth is not a function of a few blockbuster drug discoveries. It parallels an extraordinary rise in the portion of the population, particularly children, diagnosed with mental illness.  For example, if diagnoses mirror the actual incidence of juvenile polar disorder, that affliction grew forty-fold between 1993 and 2004.

Have mental disorders genuinely proliferated that dramatically?  Dr. Angell suggests instead that the surge in certain diagnoses reflects a long-run shift in emphasis from “talk therapy” to medication.  This change just so happens to enable psychiatrists to see more patients and earn higher fees.  Not incidentally, with drugs now regarded as the preferred mode of treatment, the increase in diagnoses is a boon to pharmaceutical manufacturers.  The new generation of psychoactives has displaced cholesterol-reducing medications as the biggest-selling class of drugs in the U.S.

Also benefiting from the present arrangement are low-income families that receive Supplemental Security Income (SSI) payments on the basis of mental disabilities.  To qualify, applicants (children included) generally must be taking psychoactive drugs.  Getting into the program usually also ensures that the family will qualify for Medicaid.  The disbursements can be so substantial that MIT economics professor David Autor describes SSI as “the new welfare.”

The parents and two siblings of Rebecca Riley, the four-year-old who died from the effects of off-label drugs, were all on psychoactive drugs and were receiving about $30,000 a year from SSI.  Dr. Angell links the astonishing rise in diagnoses of certain mental disorders to the huge financial stakes of physicians, pharmaceutical companies and SSI recipients.

I do not want to portray this issue as an imminent or mortal threat to pharmaceutical stocks. If a ban on off-label prescription of psychoactive drugs were proposed in Congress, the companies’ lobbyists probably could stave it off for a long time.  Furthermore, the major pharmaceutical companies have widely diversified product lines, so a setback in the psychoactive category, even though it is a major growth area, would not be a body blow.

Still, this topic is one to keep an eye on for investors who hope to gain an edge by seeing beyond the quarterly EPS data.  Psychoactive drugs have been around since the 1950s, but parents can readily observe that their use with children is far more widespread than it was a generation ago.  If advocates such as Marcia Angell can make a persuasive case that the change is not fully justified on medical grounds, yet poses significant health hazards, is it unrealistic to expect a public opinion backlash some day?

[1] Marcia Angell, “The Epidemic of Mental Illness: Why?” The New York Review of Books (June 23, 2011), pp. 20-22 and “The Illusions of Psychiatry” (July 14, 2011), pp. 20-22.  The article is a review of three books on the contemporary practice of psychiatry by Irving Kirsch, Robert Whitaker, and Daniel Carlat.

http://blogs.forbes.com/investor/2011/06/30/bad-side-effects-ahead-for-pharma/

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Selling Depression—Adding New Spin and Urgency to Depression Drug Sales

Tuesday, June 21st, 2011

CounterPunch – June 19 Edition

by Martha Rosenberg

The discovery that many people with life problem or occasional bad moods would willingly dose themselves with antidepressants sailed the drug industry through the 2000s. A good chunk of the $4.5 billion a year direct-to-consumer advertising has been devoted to convincing people they don’t have problems with their job, the economy and their family, they have depression. Especially because depression can’t be diagnosed from a blood test.

Unfortunately, three things dried up the depression gravy train for the drug industry. Blockbusters went off patent and generics took off, antidepressants were linked with gory and unpredictable violence, especially in young users and — they didn’t even work, according to medical articles!

That’s when the drug industry began debuting the concept of “treatment resistant depression.” It wasn’t that their drugs didn’t work (or you didn’t have depression in the first place), you had “treatment resistant depression.” Your first expensive and dangerous drug needed to be coupled with more expensive and dangerous drugs because monotherapy, one drug alone, wasn’t doing the trick!

You’ve got to admire the drug industry’s audacity with this upsell strategy. Adding drugs to your treatment resistant depression triples its take, patients don’t know which drug is working so they’ll take all of them and the defective drugs are exonerated! (Because the problem is you.)

Now the drug industry has a new whisper campaign to keep the antidepressant boat afloat. Your depression is “progressive.”

Once upon a time, when depression was neither seasonal, atypical, bipolar or treatment resistant, it was considered to be a self-limiting disease. In fact, just about the only good thing you could say about depression was it wouldn’t last forever.

But now, the drug industry is giving depression the don’t-wait scare treatment like coronary events (statins), asthma attacks (“controller” drugs) and thinning bones (Sally Field). If you don’t hurry and take medication, your depression will get worse!

“Depressive episodes become more easily triggered over time,” floats an article on the physician Web site Medscape (flanked by ads for the antidepressant Pristiq.) “As the number of major depressive episodes increase, the risk for subsequent episodes is predicted more from the number of prior episodes and less from the occurrence of a recent life stress.” The article, unabashedly titled “Neurobiology of Depression: Major Depressive Disorder as a Progressive Illness,” is written by Vladimir Maletic who happens to have served on Eli Lilly’s Speaker’s Bureau, says the disclosure information, and whose co-authors are each employees and/or Lilly shareholders.

On WebMD, a sister site to Medscape, the depression sell is even less subtle. An article called Recognizing the Symptoms of Depression, smothered with five ads for the Eli Lilly antidepressant, Cymbalta, submits, “Most of us know about the emotional symptoms of depression. But you may not know that depression can be associated with many physical symptoms, too.”

Depression may masquerade as headaches, insomnia, fatigue, backache, dizziness, lightheadedness or appetite problems mongers the article. “You might feel queasy or nauseous. You might have diarrhea or become chronically constipated.” And here, you thought it was something you ate!

The danger with these symptoms says the article is that you would fail to diagnose yourself as suffering from a psychiatric problem and buy an over-the-counter drug like a normal person. “Because these symptoms occur with many conditions, many depressed people never get help, because they don’t know that their physical symptoms might be caused by depression. A lot of doctors miss the symptoms, too.”

But when head and backaches aren’t labeled as depression, the drug industry make no money and insurance rates could stop climbing from over-treatment with unnecessary, expensive and dangerous psychoactive drugs!

To prevent such goring of marketshare, the article (whose content was “selected and controlled by WebMD’s editorial staff and is funded by Lilly USA,” an original WebMD financial partner according to the Washington Post) counsels worry about physical symptoms. “Don’t assume they’ll go away on their own.” Symptoms may “need additional treatment” and “some antidepressants, such as Cymbalta and Effexor, may help with chronic pain, too.”

Before direct-to-consumer advertising, the health care system was devoted to preventing over-treatment and assuring patients they were probably okay. Who remembers “Take two aspirin and call me in the morning”? Now patients are assured they probably aren’t okay but probably have a progressive disease. Luckily their disease can be treated with progressive prescriptions from pharma.

http://www.counterpunch.org/rosenberg06172011.html

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Beware the ghost(writer)s of medical research

Friday, June 17th, 2011

The One Click Group – June 16, 2011

By Dr. Marc-André Gagnon
 and Dr. Sergio Sismondo
 Expert Advisors – EvidenceNetwork.ca

The medical research world has been concerned about the problem of ghostwriting for more than a decade.

The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

How ghostwriting feeds Big Pharma profits

Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the AustralasSian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.

In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review”, or CASPPER, a playful reference to the “friendly ghost”. Such strategies are not exceptions; they are now the norm in the industry. Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge and create market share and market niches for their products.

A call for Evidence-Based medicine

In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive.

Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.

Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

Corporate science

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.

As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

http://www.theoneclickgroup.co.uk/news.php?id=6349#newspost

Dr. Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr. Sergio Sismondo is professor of Philosophy and Sociology at Queen’s University. His current research is on the pharmaceutical industry’s relationships with academic medicine and practicing physicians.

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Feds to start directly targeting drug company execs in health care fraud schemes

Saturday, June 11th, 2011

Natural News – June 10, 2011

by Ethan A. Huff

The days of drug companies simply settling out of court every time they break the law may soon be coming to an end. In a move that represents a significant shift toward punishing individuals for crimes rather than faceless corporations, federal officials say they will begin personally going after CEOs and other company executives whose companies fraudulently bilk Medicare, Medicaid, and other federal programs out of millions of dollars, or that falsely market dangerous drugs.

When a 1996 law was passed that banned drug companies convicted of felony charges from further participating in any federal health programs, Big Pharma quickly devised creative ways to get around it. As a result, drug companies for years have been able to continually break the law without much consequence by simply settling for a few million dollars, and continuing on with shady dealings that raked in a whole lot more (http://www.naturalnews.com/001867.html).

But now, company execs could face criminal charges for crimes committed by their companies, even if they claim to have had no awareness that any crimes were being committed. And drug companies will no longer be able to skirt by after breaking the law — if they cheat the government health system, they will lose any eligibility to participate in it. After all, ignorance of the law or of the illicit dealings of one’s company have never been a legitimate excuse for anyone else to evade justice — why should it be any different for drug companies?

“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department (HHS), to The  Washington Post.

“To our way of thinking, the men and women in the corporate suite aren’t getting it. If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”

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The Depression Drug Gravy Train – Marketing Life’s Problems as a ‘Disease’

Monday, June 6th, 2011
Op-Ed News – June 5, 2011
by Martha Rosenberg
The discovery that many people with life problems or occasional bad moods would willingly dose themselves with antidepressants sailed pharma through the 2000s. A good chunk of pharma’s $4.5 billion direct-to-consumer advertising has been devoted to convincing people they don’t have problems with their job, the economy and their family, they have depression. Especially because depression can’t be diagnosed from a blood test.

Unfortunately, three things dried up the depression gravy train for pharma. Blockbusters went off patent and generics took off, antidepressants were linked with gory and unpredictable violence, especially in young users and…they didn’t even work, according to medical articles!

That’s when pharma began debuting the concept of “treatment resistant depression.” It wasn’t that their drugs didn’t work (or you didn’t have depression in the first place), you had “treatment resistant depression.” Your first expensive and dangerous drug needed to be coupled with more expensive and dangerous drugs because monotherapy, one drug alone, wasn’t doing the trick!

You’ve got to admire pharma’s audacity with this upsell strategy. Adding drugs to your treatment resistant depression triples its take, patients don’t know which drug is working so they’ll take all of them and the defective drugs are exonerated!   (Because the problem is you.)

Now pharma has a new whisper campaign to keep the antidepressant boat afloat. Your depression is “progressive.”

Once upon a time, when depression was neither seasonal, atypical, bipolar or treatment resistant, it was considered to be a self-limiting disease. In fact, just about the only good thing you could say about depression was it wouldn’t last forever.

But now, pharma is giving depression the don’t-wait scare treatment like coronary events (statins), asthma attacks (“controller” drugs) and thinning bones (Sally Field). If you don’t hurry and take medication, your depression will get worse!

“Depressive episodes become more easily triggered over time,” floats an article on the physician web site Medscape (flanked by ads for the antidepressant Pristiq.) “As the number of major depressive episodes increase, the risk for subsequent episodes is predicted more from the number of prior episodes and less from the occurrence of a recent life stress.” The article, unabashedly titled“Neurobiology of Depression: Major Depressive Disorder as a Progressive Illness ,” is written by Vladimir Maletic who happens to have served on Eli Lilly’s Speaker’s Bureau, says the disclosure information, and whose co-authors are each employees and/or Lilly shareholders.

Before direct-to-consumer advertising, the health care system was devoted to preventing over-treatment and assuring patients they were probably okay. Who remembers “Take two aspirin and call me in the morning”?   Now patients are assured they probably aren’t okay but probably have a progressive disease. Luckily their disease can be treated with progressive prescriptions from pharma.

http://www.opednews.com/articles/Do-You-Have-Depression-He-by-Martha-Rosenberg-110605-409.html

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