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How Did These Babies Die? Question unites grieving families

admin — Tue, 02 Aug 2011 16:15:42 +0000

BC LocalNews.com – August 1, 2011

by Jeremy Deutsch

Matthew Schultz was only 2.5 hours old when he died on Feb. 21, 2009. A coroner’s report stated there was no anatomical or toxicological cause of death, which was deemed “natural”. Another baby, Greyson Rawkins, was only two months old when he died on March 23 of this year. A coroner’s report found Greyson died of sudden unexplained death in infancy and his death was ruled undetermined. However, the mothers of both babies were taking Effexor while carrying and believe the antidepressant drug may be connected to the deaths of their children. And, as KTW learned, there are widespread medical warnings about pregnant women taking antidepressants.

Two hours is not a lot of time, but for little Matthew Schultz, it was his entire life.

One moment, Amery Schultz held Matthew in his arms. The next moment, his child was dead.

As the Merritt family struggled to deal with their grief, two years later and 45 minutes away in Kamloops, another family would be shattered by the sudden loss of a newborn.

Greyson Maxwell Rawkins was found one morning by his mother, cold and unresponsive.

The two-month old was dead.

Unlike most sudden-infant deaths, which go largely unexplained, both families believe they know exactly what killed their sons — an antidepressant called Effexor.

Matthew was born on February 21, 2009, at 2:21 a.m. at Royal Inland Hospital.

Right from birth, the newborn had poor colouring and trouble breathing.

Schultz said he and wife Christiane argued with medical staff at the hospital about Matthew’s symptoms, only to be told they was normal.

An hour later, alone in the hospital room, Amery held Matthew in his arms.

He was gently rocking his fifth child to sleep and noted the baby’s lips were a bit purple.

Matthew fell asleep in his father’s lap.

Moments later, a nurse came into the room and noticed the new born was pale and unresponsive.

Matthew was in complete respiratory and cardiac arrest.

Medical staff were unable to revive him and he was pronounced dead an hour later.

“Losing your child — you can’t explain it,” Amery said.

“It tears a hole in your heart that will never heal.”

The B.C. Coroners Service listed Matthew’s death as natural — as far as the coroner was concerned, it was a case of sudden infant death syndrome (SIDS).

However, the Schultzes were not convinced.

The couple started to do their own research and were dismayed by what they found.

Christiane had been taking the antidepressant Effexor, also known by its clinical name venlafaxine, for years prior to Matthew’s birth and during pregnancy.

Three previous children were also exposed to the drug.

Unbeknownst to the couple, venlafaxine had been under a Health Canada warning since 2004.

The government agency had advised that newborns may be adversely affected when pregnant women take a specific group of antidepressants during the third trimester of pregnancy.

The list included venlafaxine.

The Schultzes said their family doctor never told them about the possible risks of taking the drug during pregnancy.

“I asked every pregnancy, ‘Should I get off of these?’” Christiane said.

“But I was told, ‘No, they’re fine, they’re perfectly safe.’”

Convinced Effexor contributed to Matthew’s death, the family awaited the final report from the coroner, hoping to get some answers as to the cause of their son’s death.

They were also hoping the coroner would make recommendations so other families wouldn’t suffer through a similar loss.

But the report, which the Schultzes received on the two-year anniversary of Matthew’s short life and death, surprised and angered the family.

It made no recommendations and found no cause of death.

According to the coroner’s report, a detailed autopsy on Matthew showed no anatomic cause of death, but the possibility was raised of venlafaxine exposure being a contributing factor.

Brain-tissue samples were sent to a research facility in the U.S. for examination to determine if there was an underlying susceptibility to the class of antidepressants.

But the report noted it was unclear how prenatal exposure to Effexor might have contributed to Matthew’s death, if at all.

The report concluded the significance of the exposure to venlafaxine in utero is unknown and made no recommendations.

“At best, I can’t bring my son back,” Amery said.

“But to call his death natural, certainly it’s not.”

He argued the coroners office has ignored what he considers overwhelming evidence the drug played a role in his son’s death.

The report itself listed exposure to venlafaxine under the category of other conditions contributing to death.

Physician and coroner Karla Pederson, with the B.C. Coroner’s Service, looked over the results of the report and is satisfied the office went to great lengths to find the cause of death.

“We are not making a presumption that we know what caused the death of this child, because we do not know,” she said.

When asked if the coroners service is concerned about the use of antidepressants during pregnancy, Pederson noted the drugs are used by thousands, if not millions, of pregnant women around the world without resulting in infant death.

Greyson Rawkins was born on Jan. 24, 2011, at RIH.

Like Matthew Schultz, little Greyson had trouble breathing at birth and spent five days in the hospital before he could go home for the first time.

“He was just different from my first,” said Greyson’s mother, Nicole Rawkins, who noted her second child weighed less and slept much more than her daughter, Layla, now three years old.

During her entire pregnancy, Rawkins said she was taking a prescribed 450-milligram daily dose of Effexor to help her depression.

It was more than five times the amount she took during her first pregnancy.

The 31-year-old Rawkins was also taking another drug called Seroquel, between 100 and 150 milligrams a day, which is used to treat bipolar depression.

She said her doctor never told her of the risks.

After two months, though, Greyson appeared to be doing well.

That was until the evening of March 22 of this year.

Rawkins put Greyson to sleep in his bassinet, in the same room with her and her boyfriend.

But the two-month old was being fussy, so mom brought him into her bed for nursing.

They fell asleep, with Greyson lying on the edge of the bed with his mom.

At around 4 a.m., Greyson’s older sister decided to climb into bed, while Rawkins’ boyfriend moved to a couch.

Five hours later, Rawkins awoke to find her son cold and unresponsive.

“I shook him a bit, but he was floppy,” she recalled.

Emergency services was dispatched, but it was too late.

Greyson was dead.

Rawkins thought she had accidently killed her baby, but that wasn’t the case.

A coroner’s report released at the end of June listed the death as undetermined and classified it as SIDS.

As in the Schultzes’ case, the autopsy noted Effexor and Seroquel as risk factors for SIDS in the case, but added it could not be determined by a pathological exam.

An autopsy on Greyson also stated the respiratory complications at birth were considered likely secondary to withdrawal effects from utero exposure to venlafaxine.

Despite the findings, Rawkins said the blame in Greyson’s death has fallen on her shoulders.

“I wasn’t allowed to grieve because everyone was watching me,” she said.

After getting in contact with the Schultz family and sharing their stories, Rawkins is also certain the antidepressants she had taken for months played a role in Greyson’s death.

The two mothers have been carrying around their own guilt because they unwittingly exposed their children to the drug.

“Every day I look at them and I did that to them because I didn’t look up the safety of the drug,” said Christiane.

“Every day is guilt.”

http://www.bclocalnews.com/news/126547313.html

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

admin — Thu, 21 Jul 2011 15:51:33 +0000

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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The Small Group of Thoughtful, Committed Citizens Has Been Drugged

cchrint — Tue, 24 May 2011 16:59:54 +0000

OpEdNews
By David Swanson
May 23, 2011

Movements for justice have historically been driven by a small percentage of any population. One percent of Americans nonviolently occupying Washington, D.C., could make Cairo and Madison and Madrid look like warm-up acts. It is certainly true that a small group of thoughtful, committed citizens is the only thing that ever has changed the world for the better.

So, what happens if a society picks out a significant slice of its population, one including many thoughtful and committed citizens, and drugs them?

The Drug Enforcement Administration (DEA) held a first-time, one-day, little publicized event last September that allowed people to turn in their extra prescription drugs. The DEA reports collecting 242,000 pounds or 121 tons. A second such day was held in April with 376,593 pounds or 188 tons of pills collected. This is the stuff nobody wants and is willing to hand in to the government. This is not the amount that’s out in circulation. That amount is no doubt in proportion to the roaring flood of television ads for the stuff. “More Americans currently abuse prescription drugs,” says the DEA, “than the number of those using cocaine, hallucinogens, and heroin combined. . . . [I]ndividuals that abuse prescription drugs often obtained them from family and friends, including from the home medicine cabinet.” And that’s just the users said to be abusing.

Ted Rall suggested drugging to me as a possible explanation for the big mystery staring us in the face, namely why Americans sit back and take so much more than other people from their government. The Patriot Act is being put on steroids with hardly a peep of protest. The “Defense Authorization Act” now before Congress would give presidents virtually limitless power to single-handedly make wars or imprison people. This is the biggest formal transfer of power in the U.S. government since the drafting of its Constitution. This undoes the American War for Independence. But perhaps we’d still be 13 colonies if Prozac and Zoloft had come along sooner.

“Like many people,” says Rall, “I have often wondered why so many Americans seem so emotionally flat and politically apathetic in response to a political and economic landscape that cries out for protest, or at least complaint. Could it be that our society’s most angry — justifiably angry — are being medicated into quiescence?” It does seem possible. I don’t mean to discount the fact that the United States imprisons record numbers of people. I’m willing to share some blame with our education system, our so-called news media, our religiosity, the two-party trap, and several other likely factors. But drugs looks like the big one that is nonetheless hardest to see. People don’t usually tell you they’re drugged, but chances are at least one in 10 people you meet is.

Two years ago, a study found that “the number of Americans taking antidepressants doubled to 10.1 percent of the population in 2005 compared with 1996, increasing across income and age groups.” One year earlier, another study had found that close to 10 percent of men and women in America were taking drugs to combat depression, and that 11 percent of women were taking antidepressants.”

Author and clinical psychologist Bruce Levine tells me this may be even worse than it sounds. “If you are around certain populations,” Levine says, “that 10 percent stat seems very low, especially among healthcare professionals and college students.” College students? I can remember them getting pretty thoughtful and committed in times past. “And that 10 percent,” Levine adds, “only includes the ‘official antidepressants’ such as Prozac, Paxil, Zoloft, Lexapro, Wellbutrin, Effexor, etc. This stat doesn’t include people using ADHD drugs such as Ritalin, Adderall, etc. to stimulate themselves.”

Adderall, Levine explained, is an amphetamine that affects the same neurotransmitters as cocaine (dopamine, serotonin, and norepinephrine), “and if one takes the antidepressant Effexor (affects serotonin and norepinephrine) at the same time one is taking the antidepressant Wellbutrin (affects dopamine), one can sense the hypocrisy in labeling certain psychotropics (drugs that affects neurotransmitters) as ‘antidepressants’ and other psychotropics as ‘ADHD psychostimulants.’ Lots of people — especially young people — are popping ‘Addies’ (street name for Adderall) to ‘motivate’ them to get them through their lives, especially during exam time.”

Levine said he’s counseling a young man who is supplementing his income by selling ADHD psychostimulant drugs to his fellow college students. He gets the best price around final exam time. “He told me, ‘Bruce, you’ve got to do better improving the self-esteem of these young kids who you are counseling.’ Why, I ask him, why do you care? ‘Well,’ he says, ‘these little brats who are getting their freebie prescription Addies feel so crappie about themselves that they are giving away their Addies to their older brothers for free just so they will hang out with them, and all those freebie Addies on the market are driving price down for me.”

Levine stresses that Adderall, like nicotine or caffeine or cocaine, provides a buzz that antidepressants do not. In fact, he points out, the so-called antidepressant drugs make people twice as likely to commit suicide. Levine concedes that some people swear antidepressants have saved their lives, but points out that people will say that about a placebo as well. The evidence, Levine says, shows antidepressants working no better than a placebo at lifting people out of depression.

Antidepressants may bear as Orwellian a name as the Patriot Act, but Levine finds the latter easier to talk about with people. “I get less grief,” Levine tells me, “when I talk about something like anarchism and Emma Goldman than when I talk about antidepressants’ effectiveness and [author] Irving Kirsch, as abstract political ideologies are far less threatening than people’s very own drugs.” Political movements may in fact be less threatening to those in power, because of people’s drugs.

Read article here: http://www.opednews.com/articles/The-Small-Group-of-Thought-by-David-Swanson-110523-181.html

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Panel to Examine Murder and Suicide Associated With Antidepressants

admin — Tue, 22 Mar 2011 19:39:58 +0000

The Huffington Post, March 22, 2011
by Dr. Peter Breggin

Click image to visit the Psychiatric Drug Database

On Saturday morning April 9th of this year, a panel discussion will be held for the public and professionals on the theme of “Psychiatric Drug Tragedies: Personal, Legal and Medical Perspectives.”

The two-hour presentation focuses on suicide and murder potentially caused by antidepressant medications. It is part of the international Empathic Therapy Conference put on by the Center for the Study of Empathic Therapy, Education & Living (April 8-10, 2011 in Syracuse, New York).

The panel will present a unique examination of an antidepressant-related suicide from three perspectives: Mathy Downing, the mother of a twelve-old-child who committed suicide; Karl Protil, the lawyer in her case, which was settled without any admission of negligence; and myself as the medical expert in the case. Mathy will be accompanied by her surviving daughter. Other family members will tell the stories of two more children who committed suicide, a father who committed suicide, and a husband who murdered his two young children–all while taking prescribed antidepressants.

A great deal is now known about suicide and violence in association with the newer antidepressants such as Prozac (fluoxetine), Paxil (paroxetine), Zoloft (sertraline), Luvox (fluvoxamine), Celexa (escitalopram), Lexapro (escitalopram), Cymbalta (duloxetine), Effexor (venlavaxine), Pristiq desvenlafaxine), and Wellbutrin (bupropion).

The FDA has imposed a Black Box on all antidepressant labels that warns against the risk of suicidal behavior in children, youth and young adults. Click here to find the example of Prozac’s official prescribing information. More importantly and more broadly, the new labels also warn about the risk of aggression, hostility, mania, and an overall worsening of the individual’s mental condition, for all ages. The new FDA-approved labels also include a Medication Guide, which the FDA urges prescribers to give to patients and their families. Originally intended for children taking antidepressants, it now has no age limitation and pertains to all ages. The Medication Guide warns patients and their families to be aware of the possibility of suicidal and violent behavior, mania, and a long litany of other dangerous mental abnormalities.

The new FDA-approved antidepressant labels confirm that the risks are highest at the start of medication therapy or during changes in dose, either up or down. To a great extent, the labels read like my prior publications, one of which was given by the FDA to its outside expert committee that recommended the changes to the labels.

Unfortunately, many psychiatrists, internists, family doctors, nurse practitioners and other professionals continue to prescribe these medications, too often without providing adequate information to the patient and the family. As a result, I was asked to write about the implications of these new labels for the most widely read psychiatric journal for primary care prescribers. The panel at the Empathic Therapy Conference, the first of its kind, will explore these tragedies and put a human face on them through the presence and presentations of surviving family members.

Other aspects of the conference will describe empathic approaches to helping a wide variety of emotional conditions and problems in children and adults. Speakers will bring unique and inspiring approaches to children and adults given psychiatric diagnoses, ordinary folks who are suffering from stress, street people overcome by psychosis, military personnel recovering from PTSD and head injuries, and elderly victims of dementia. Professionals and the general public are welcome at the Empathic Therapy Conference in Syracuse, New York, April 8-10, 2011. Continuing education credits (CEs) for 29.5 hours are available.

Peter R. Breggin, MD is a psychiatrist in private practice in Ithaca, New York, and the author of dozens of scientific articles and more than twenty books including Toxic Psychiatry: Why Therapy, Empathy and Love Must Replace the Drugs, Electroshock and Biochemical Theories of the “New” Psychiatry, as well as his newest book, Medication Madness. The Empathic Therapy Conference brings together more than forty presenters and a diverse audience from around the world. Professionals and nonprofessionals are welcome. Learn about the conference at http://www.empathictherapy.org.

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A sugared pill

cchrint — Wed, 09 Mar 2011 20:46:23 +0000

Financial Times
By Andrew Jack
March 8, 2011

Stefan Kruszewski, a US psychiatrist who has been a whistleblower against pharma companies in three recent cases that resulted in settlements, warns that the legacy of the past will generate yet more pain. “Some companies have got better,” he says. “But there is more to come out.”

When Daniel Carlat, a psychiatrist in Massachusetts, was flown to New York with his wife by Wyeth, the “training” weekend he attended in a luxury hotel was topped off with a Broadway show. It was early 2001 and he had just agreed to the US pharmaceuticals company’s proposal that he give talks to doctors about its antidepressant Effexor.

During the following year, he was regularly paid fees of $750 a time to drive to “lunch and learn” sessions where he would speak for 10 minutes to emphasise the drug’s advantages to fellow doctors, using slides prepared by the company. “It seemed like a win-win,” he recalls. “I was prescribing it, educating doctors and making some money.”

But within a few months, he became disillusioned with his co-option as a marketing representative. He was selectively presenting clinical data that put the drug in a positive light to physicians who had been targeted by the company through “data mining” techniques that identified their individual prescription patterns.

Dr Carlat has spoken out as part of a growing backlash against such aggressive marketing tactics, which are leading to significant changes in the relationship between doctors and drug companies. But even as pharmaceuticals executives argue that such problems belong to the past and were always exaggerated, they are bracing for both intensifying penalties and calls for further reform.

“In some ways, our industry lost its way and failed to fully appreciate the evolving expectations of our stakeholders,” Deirdre Connelly, head of North American operations at GlaxoSmithKline, told a conference in January. While playing down the extent of the problem, she conceded: “No matter the reasons, at the end of the day, we must regain the public’s trust.”

Her comments came as the UK-based company put aside provisions of £2.2bn ($3.6bn), largely to cover a settlement under negotiation with the US district attorney’s office for Colorado over sales and promotional practices between 1997 and 2004 for drugs including its antidepressants Paxil and Wellbutrin. A report in January by Morgan Stanley, the investment bank, predicted a surge in litigation, including against GSK, as still undisclosed “whistleblower” lawsuits and regulatory settlements translate into claims totalling billions of dollars for the industry in the coming months.

At the heart of the problem is a wide-ranging, cosy and opaque relationship between companies and physicians – one that often includes money or other benefits changing hands. For most in the industry, such links are essential to understanding diseases and patient needs, developing effective medicines and providing education on them to prescribers.

US authorities have taken the lead, investigating practices used in other countries as well as at home. Authorities elsewhere, including in the UK, France and Italy, have also been scrutinising arrangements.

Chris Viehbacher, head of Sanofi-Aventis, the French drugmaker, rejects the suggestion that payments need cause insuperable problems. “Doctors are professionals and I have every confidence in their judgment,” he says, arguing that payments from companies need not undermine the integrity of prescribers.

Yet others argue that payments to doctors have at times resulted in the prescription of medicines to patients who do not stand to benefit, risking suboptimal or even dangerous treatment and substantial and unnecessary costs to health systems.

“The industry has made important steps to clean up its act, but more needs to be done,” says Richard Horton, editor of The Lancet, the medical journal. He chaired a working party at the UK’s Royal College of Physicians two years ago that launched recommendations to rebalance the relationship between the industry, academia and the taxpayer-funded National Health Service. In the face of a lack of consensus and practical difficulties, many have yet to be implemented.

He and others say questionable links between doctors and industry reached their apogee in the US at the start of the millennium, when fierce competition among companies at a time of slowing innovation resulted in the creation of a slew of “me too” drugs, often with little advantage over existing treatments. Pressure from increasingly aggressive makers of low-cost generic versions of out-of-patent proprietary products heightened the urgency of maximising sales. Companies were spending heavily on media advertisements – often including celebrity endorsements – to persuade patients to lobby doctors for prescriptions of their products.

Above all, a wave of takeovers spurred by falling productivity left newly expanded groups such as Pfizer with thousands of sales “reps”, often recruited more for their charm than their medical expertise, charged with visiting doctors to persuade them to prescribe their drugs. This created an “arms race” among leading companies, often with barely distinguishable products.

One tool used in the US was “sampling”, whereby reps would leave free supplies of their often costly drugs with doctors, who were able to hand them out to patients without medical insurance. They also paid for physicians’ meals and even petrol.

In Europe and most other industrialised regions, direct-to-consumer advertising of prescription medicines is typically banned or tightly controlled, and free samples are less relevant in markets where drugs are largely paid for by governments.

Yet close links between sales reps and doctors have been widespread – and not always limited to small gifts such as pens, notepads and coffee mugs. There have also been allegations of significant payments, some of which are under scrutiny by federal investigators focusing on the overseas activities of companies operating in the US.

In the UK, US-based Abbott Laboratories was severely reprimanded by the Association of the British Pharmaceutical Industry in 2006 after reps took doctors to Wimbledon matches, greyhound races and a lap-dancing club. Two years later, Swiss-based Roche suffered the same fate after encouraging the sale of weight-loss pills to individuals in private slimming clinics not qualified to prescribe.

. . .

Practising doctors are required by their own professional bodies to participate in “continuing medical education” sessions to keep up to date. But speakers and themes can be influenced by drugmakers. Often flown business class with their spouses to resorts in exotic locations, doctors around the world attend scientific conferences where companies hold “satellite” sessions presenting their products in a favourable light.

While Dr Carlat participated in such “speaker bureaus”, other “key opinion leaders” were paid as consultants for a variety of services. Those included advice on the design and writing up of clinical drug trials and adding their names and credibility to articles ghost-written by specialist authors hired by the companies.

A series of studies has demonstrated that industry-sponsored trials published in medical journals – a cornerstone of marketing to doctors – generally favour their drugs. Trials with less promising results are not generally published. This can distort the true picture of risks and benefits of medicines.

The full extent of such marketing activities and any distortion of prescribing practices is unclear. But “sunshine” legislation introduced as part of US President Barack Obama’s healthcare reforms is beginning to reveal the amount companies have been willing to spend. According to an analysis by ProPublica, an investigative journalism agency, the first eight companies to disclose their spending paid a total of $320m in 2009-10 to 18,000 doctors, the top 10 of whom received more than $250,000 each.

Such transparency is itself accelerating reform. Companies – some forced by legal settlements, others persuaded by the requirements of government funders and medical journals – are making details of their clinical studies available on public websites, allowing scrutiny by independent researchers. GSK this year changed its payment system for reps, hiring and assessing them based on medical expertise and removing commissions linked directly to sales.

Organisations including Britain’s ABPI, its Swedish counterpart Lif, and Efpia, the European Union-wide trade body for the sector, have introduced ever tougher codes of conduct that have restricted gifts, drug samples, entertainment and travel. In the US, the independent Institute of Medicine has called for far more aggressive measures to control continuing medical education, in order to put content at arm’s length from drug companies. The National Institutes of Health, the US federal research funder, is revising its conflict of interest codes for grant recipients, and many medical schools have taken similar steps to clamp down on industry influence on faculty members.

But such measures have proved partial. Disclosure of clinical trial results remains patchy, and pledges to publish payments to doctors in Europe are less comprehensive than those in the US. The ethics code of Phrma, the US trade grouping, has no enforcement mechanism. Ifpma, the international body, has only ever considered – and then rejected – four complaints against companies.

Susan Chimonas, of New York’s Columbia University, says the medical profession must take more responsibility. She highlights a recent study that found the majority of US medical schools had weak or non-existent conflict of interest guidelines on payments to their faculty. “It takes two to tango,” she argues. “Industry is behaving the way industry is expected to in a capitalist system, but the medical profession has lost its way. Prescribers are willing partners.”

In the UK Des Spence, a Glasgow doctor who founded a national chapter of the No Free Lunch movement, which rejects drug company hospitality, points out that the NHS is supposed to provide registers of payments to doctors, but few disclosures have been made. The General Medical Council, the profession’s regulator, has shown little interest.

. . .

The greatest pressure for reform has come from governments and health insurers. A growing trend towards rigorous and continuing comparative data on drugs’ safety, efficacy and cost-effectiveness is shifting prescription powers from individual doctors to technical organisations such as the UK’s National Institute for Health and Clinical Excellence.

The result has been a cull in tens of thousands of drug reps in the industrialised world in the past few years, although their numbers have been growing in the less-regulated emerging markets to which the pharmaceuticals companies are increasingly turning. If some of the more egregious payments to doctors are on the wane, that leaves more subtle issues such as the independence of continuing medical education. If the drug industry pulls back, either individual doctors or their employers will have to provide funding instead.

With austerity measures squeezing government health spending in many countries, and UK changes giving more powers to family doctors, the solution will not be easy. Stefan Kruszewski, a US psychiatrist who has been a whistleblower against pharma companies in three recent cases that resulted in settlements, warns that the legacy of the past will generate yet more pain. “Some companies have got better,” he says. “But there is more to come out.”

Read the rest of the article here:

http://www.ft.com/cms/s/0/ae7099a0-49bc-11e0-acf0-00144feab49a.html#axzz1G80Pn69u

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Note to Press Re: Arizona Shooting—Before Touting Pharma’s “More Mental Health Treatment Needed” Line – Try Asking The Right Questions

admin — Wed, 12 Jan 2011 22:49:52 +0000

By CCHR International

10 recent massacres were committed by those under the influence of psychiatric drugs resulting in 54 dead and 105 wounded

Every single time there is a school shooting, or some senseless massacre, the press are quick to start touting the need for more mental health treatment to “prevent” these tragedies—well before the facts of the case have been investigated. In fact, most of the press don’t appear as interested in bringing the facts to light as they are in making “recommendations” based on assumptions and calling for more mental health services/treatments. How one can make recommendations before finding out what actually occurred seems illogical to us, and we’re hoping we’re not the only ones. What also seems illogical is the lack of direct questioning and demand for answers given the facts already known about prior massacres/shootings, such as: The majority of those who committed such acts had already undergone mental health “treatment,” and were already on psychiatric drugs. Drugs documented by international drug regulatory agencies to cause violence, mania, psychosis, hallucinations, suicide and even homicidal ideation.

In the case of prior massacres/shootings, what has repeatedly occurred is that when the facts finally came out, due solely to the efforts of those few determined investigative reporters (such as Fox National News reporter Douglas Kennedy), and it was revealed that the shooter had been under the influence of psychiatric drugs, or in withdrawal from them, most of the press were quick to counter the drug/violence connection by featuring some Pharma mouthpiece touting the “there is no evidence that these drugs cause violent or homicidal behavior” line.

Really? No evidence? There have been 22 International Drug Regulatory Agency Warnings on psychiatric drugs causing violence, mania, psychosis and even homicidal ideation. These warnings have been issued by drug regulatory agencies in the United States, the European Union, Japan, The United Kingdom, Australia and Canada.

And consider that just last week, TIME Magazine reported on a study from the Institute for Safe Medication Practices that “based on data from the FDA’s Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.” And out of the Top 10, 8 were psychiatric drugs.

From Time Magazine: “When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

The Top 10 included the Antidepressants Pristiq, Effexor, Luvox, Paxil, Prozac, ADHD Drugs, Strattera and the Anti-Anxiety drug, Halcion.

Now, to be perfectly clear, we’re not saying for a fact that Loughner was taking psychiatric drugs at the time of the shooting, or in the past, which studies show can cause long-term damage long after an individual has stopped taking them. We’re saying, why aren’t the press finding out? Consider that 10 recent massacres were committed by those under the influence of psychiatric drugs documented to cause mania, psychosis, violence and even homicide, resulting in 54 dead and 105 wounded—and those are just the ones we know about. In several cases, medical records were sealed or autopsy reports not made public or, in some cases, toxicology tests were either not done to test for psychiatric drugs, or not disclosed to the public. But let’s just consider what we do know about the mental health “treatment” of those who committed these acts of violence:

Dekalb, Illinois – February 14, 2008: 27-year-old Steven Kazmierczak shot and killed five people and wounded 16 others before killing himself in a Northern Illinois University auditorium. According to his girlfriend, he had recently been taking Prozac, Xanax and Ambien. Toxicology results showed that he still had trace amount of Xanax in his system.

Omaha, Nebraska – December 5, 2007: 19-year-old Robert Hawkins killed eight people and wounded five before committing suicide in an Omaha mall. Hawkins’ friend told CNN that the gunman was on antidepressants, and autopsy results confirmed he was under the influence of the “anti-anxiety” drug Valium.

Jokela, Finland – November 7, 2007: 18-year-old Finnish gunman Pekka-Eric Auvinen had been taking antidepressants before he killed eight people and wounded a dozen more at Jokela High School in southern Finland, then committed suicide.

Cleveland, Ohio – October 10, 2007: 14-year-old Asa Coon stormed through his school with a gun in each hand, shooting and wounding four before taking his own life. Court records show Coon had been placed on the antidepressant Trazodone.

Blacksburg, Virginia – April 16, 2007: 23-year-old Seung Hui Cho shot to death 32 students and faculty of Virginia Tech, wounding 17 more, and then killing himself. He had received prior mental health treatment, however his mental health records remained sealed.

Red Lake, Minnesota – March 2005: 16-year-old Jeff Weise, on Prozac, shot and killed his grandparents, then went to his school on the Red Lake Indian Reservation where he shot dead 7 students and a teacher, and wounded 7 before killing himself.

Greenbush, New York – February 2004: 16-year-old Jon Romano strolled into his high school in east Greenbush and opened fire with a shotgun. Special education teacher Michael Bennett was hit in the leg. Romano had been taking “medication for depression”.

El Cajon, California – March 22, 2001: 18-year-old Jason Hoffman, on the antidepressants Celexa and Effexor, opened fire on his classmates, wounding three students and two teachers at Granite Hills High School.

Williamsport, Pennsylvania – March 7, 2001: 14-year-old Elizabeth Bush was taking the antidepressant Prozac when she shot at fellow students, wounding one.

Conyers, Georgia – May 20, 1999: 15-year-old T.J. Solomon was being treated with antidepressants when he opened fire on and wounded six of his classmates.

Columbine, Colorado – April 20, 1999: 18-year-old Eric Harris and his accomplice, Dylan Klebold, killed 12 students and a teacher and wounded 26 others before killing themselves. Harris was on the antidepressant Luvox. Klebold’s medical records remain sealed.

Notus, Idaho – April 16, 1999: 15-year-old Shawn Cooper fired two shotgun rounds in his school, narrowly missing students. He was taking a prescribed SSRI antidepressant and Ritalin.

Springfield, Oregon – May 21, 1998: 15-year-old Kip Kinkel murdered his parents and then proceeded to school where he opened fire on students in the cafeteria, killing two and wounding 22. Kinkel had been taking the antidepressant Prozac.

So, given the fact that these shooters were on psychiatric drugs, given the fact that 22 international drug regulatory agencies warn these drugs can cause violence, mania, psychosis, suicide and even homicide, given the fact that a major study was just released confirming these drugs put people at greater risk of becoming violent, here are the questions we think deserve to be answered.

1) Court records show that a case against Jared Loughner was dismissed on Dec. 9, 2008, after he completed some type of diversion program. What was the diversion program? Did it include mental health treatment or do the case notes include any information about any prior mental health treatment Loughner may have undergone? Such was the case of Columbine shooter Eric Harris’s “diversion program”, where case notes dated 4/16/98 revealed that “Eric has been having difficulty with his medication for depression. A few nights ago he was unable to concentrate and felt restless. He went to the doctor and the doctor is changing his medication.”

* Further note to press: Sometimes finding the psychiatric drug connection requires a bit more due diligence than just asking the question; case in point, following the Columbine massacre, the Coroner’s office initially reported no drugs were found in Eric Harris’ tox reports. Following this, an investigative reporter found that Harris was rejected from the military and psychiatric drug use was suspected as the cause for the rejection. When this became known, the coroner’s office seemed to find that Harris did in fact have the antidepressant Luvox in his system.

2) The Wall Street Journal reported, “One high-school pal said Loughner had become suicidal”. Considering the FDA has issued black box warnings that antidepressants can cause suicidal ideation (as can other psychiatric drugs) was Loughner already under the influence of these drugs?

3) The press has reported that Loughner was “barred from campus pending a psychological evaluation.” So what happened? Did he get one? Was he ever in mental health treatment, or prescribed a psychiatric drug? Ever?

As a final note: Whether or not Loughner was yet another in the long list of shooters under the influence of drugs documented to cause mania, psychosis, hallucinations, aggressive behavior, suicidal and homicidal ideation—Given the international drug regulatory agency warnings & studies, the just released Institute for Safe Medication Practices study, this much we know for certain; the last thing we need is more kids on psychiatric drugs. And given what we already know about the risks of these drugs, any recommendation for more mental health treatment, meaning more people and more kids put on these drugs, is not only negligent, but considering the possible repercussions, criminal.

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Finally—An Official Admission: Psychiatric Drugs Cause Violent & Homicidal Behavior

admin — Fri, 07 Jan 2011 20:11:16 +0000

NOTE FROM CCHRINT: Finally. An admission. From TIME Magazine no less. We at CCHR would like to take this opportunity to point out that it was due to CCHR’s efforts in 1991 that the FDA held public hearings on the antidepressant Prozac causing violence and suicide in patients. Scores of victims and families gave testimony along with medical experts that people with no prior history of violence or suicidal behavior became so under the influence of an antidepressant. However, the FDA panel, comprised of individuals and psychiatrists with heavy conflicts of interest and numerous ties to the pharmaceutical industry, ignored the evidence. It would take the FDA 13 years to finally issue black box warnings that antidepressants can induce suicidality. They have yet to issue black box warnings on antidepressants causing violence…. despite the fact numerous school shooters have been under the influence of such drugs. Watch CCHR’s exclusive footage of the 1991 FDA hearings on Prozac.

TIME MAGAZINE – JAN 7, 2011

Top Ten Legal Drugs Linked to Violence

by Maia Szalvitz

When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.

A new study from the Institute for Safe Medication Practices published in the journal PloS One and based on data from the FDA’s Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others.

Please note that this does not necessarily mean that these drugs cause violent behavior. For example, in the case of opioid pain medications like Oxycontin, people with a prior history of violent behavior may seek drugs in order to sustain an addiction, which they support via predatory crime. In the case of antipsychotics, the drugs may be given in an attempt to reduce violence by people suffering from schizophrenia and other psychotic disorders — so the drugs here might not be causing violence, but could be linked with it because they’re used to try to stop it.

Nonetheless, when one particular drug in a class of nonaddictive drugs used to treat the same problem stands out, that suggests caution: unless the drug is being used to treat radically different groups of people, that drug may actually be the problem. Researchers calculated a ratio of risk for each drug compared to the others in the database, adjusting for various relevant factors that could create misleading comparisons.

10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.

9. Venlafaxine (Effexor) A drug related to Pristiq in the same class of antidepressants, both are also used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior.

8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence

7.Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.

6) Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.

5) Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.

4) Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain’s dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.

3) Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs.

2) Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.

1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it’s 18 times more likely to be linked with violence compared to other drugs — by comparison, that number for Xyban is 3.9 and just 1.9 for nicotine replacement. Because Chantix is slightly superior in terms of quit rates in comparison to other drugs, it shouldn’t necessarily be ruled out as an option for those trying to quit, however.

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Nation of Pill Poppers: 19 Potentially Dangerous Drugs Pushed By Big Pharma

admin — Tue, 07 Dec 2010 18:50:34 +0000

AlterNet — December 6, 2010

by Martha Rosenberg

Here are some of the dicey drugs many Americans are hooked on,

thanks to greedy pharmaceutical companies.

Since direct-to-consumer drug advertising was legalized 13 years ago, Americans have become a nation of pill poppers — choosing the type of drug they desire like a new toothpaste, sometimes whether or not they need it.

But if patients want the drugs, doctors and pharma executives want them to have the drugs and media gets full page ads and huge TV flights (when many advertisers have dried up), is the national pillathon really a problem?

Yes, when you consider the cost of private and government insurance and the health of patients who take potentially dangerous drugs like these.

Seroquel, Zyprexa, Geodon, atypical antipsychotics

Even though the antipsychotic Seroquel surpasses 71 drugs on the FDA’s January quarterly report with 1766 adverse events, even though it’s linked to eight corruption scandals, even though military parents blame Seroquel for unexplained troop deaths, it is the fifth biggest-selling drug in the world and netted AstraZeneca almost $5 billion last year.

Atypicals were originally promoted to replace side-effect prone drugs like Thorazine but soon became pharmaceutical Swiss Army Knives for depression, anxiety, insomnia, bipolar and conduct disorders and other off label uses — and betrayed the same side effects as older antipsychotics. (Especially tardive dyskinesia-linked Abilify.)

Foisted disproportionately on the young, poor and disadvantaged, atypicals cause such weight gain and metabolic derangement — 16 percent of Zyprexa patients gain 66 pounds and some gain over 100 — manufacturer Lilly Eli Lilly agreed to pay the state of Alaska $15 million in 2008 for the Medicaid costs of Zyprexa patients who developed diabetes.

Atypicals carry warnings of death in demented patients but are widely used in nursing homes. And even though Risperdal maker Johnson & Johnson, Geodon maker Pfizer, Abilify maker Bristol-Myers Squibb, Lilly and AstraZeneca have all entered into government settlements that acknowledge fraudulent or wrongful atypical marketing, FDA rewarded atypical makers by approving Zyprexa and Seroquel for children last year. And approved a new atypical antipsychotic, Latuda, in October. Maybe the FDA is bipolar.

Ritalin, Concerta, Strattera, Adderall and ADHD drugs

When it comes to the epidemic of 5.3 million US children between 3 and 17 diagnosed with ADHD, suspicions of pharma pushing the disorder are exceeded only by pharma’s admissions thereof.

During an August conference call with financial analysts, Shire specialty pharmaceuticals president Mike Cola credited the “very dynamic ADHD market” to Shire’s globalization efforts and “investments we have made in new uses for our existing products.”

Those uses, a.k.a. diagnoses, for Shire products like stimulants Adderall, Vyvanse and Intuniv include adult ADHD, cognitive impairment, depression and excessive daytime sleepiness.

Still, Cola says despite the 10 percent ADHD “new starts” that are helping Shire “grow the market,” and the “co-administration market” of add-on prescription drug$, the ADHD franchise suffers from patients who drop out when they quit seeing their pediatrician. “We don’t see those patients show up again until their mid-to-late 20s,” laments Cola.

ADHD drugs, in addition to “robbing kids of their right to be kids, their right to grow, their right to experience their full range of emotions, and their right to experience the world in its full hue of colors,” as Anatomy of an Epidemic author Robert Whitaker puts it, can also be deadly.

A 2009 article in the American Journal of Psychiatry called Sudden Death and Use of Stimulant Medications in Youths found 1.8 percent of youthful stimulant users died sudden deaths from cardiac dysrhythmia or unexplained causes versus 0.4 percent who were not on stimulants. Though it helped fund the study, the FDA said the results proved no “real risk” and kids should keep taking their meds.

Meanwhile, says Robert Whitaker, kids on ADHD meds “are told they are going to be on these drugs for life. And next thing they know, they’re on two or three or four drugs,” a phenomenon also known as the co-administration market.

Prozac, Paxil, Zoloft, SSRIs

Selective serotonin reuptake inhibitor (SSRIs) antidepressants like Prozac, Paxil, Zoloft and Lexapro probably did more to inflate pharma profits in the last decade than direct-to-consumer advertising and Viagra put together, no pun intended: over 60 million prescriptions were filled in the US in 2007 with many patients reporting their depression lifted.

But some critics say for mild depression, SSRIs don’t work at all and are no better than placebo.

And others say they can add aggression, bizarre behavior, self-harm and suicidal thoughts to depression. In fact, there are 4,200 published reports of SSRI-related violence, aggression, bizarre behavior, self-harm and suicide since the drugs were introduced in 1988 including the well known gun massacres at Columbine (1999), Red Lake (2005), NIU and likely, Virginia Tech (2007).

SSRIs have non-behavioral perks both sides agree on: life-threatening serotonin syndrome when taken with migraine drugs, gastrointestinal bleeding when taken with aspirin, Aleve or Advil and the bone condition, osteoporosis.

Paxil can reduce or abolish the effect of tamoxifen in breast cancer patients and increase deaths says British Medical Journal. It’s linked to a two-fold increased risk of cardiac birth defects in infants according to its own manufacturer, GSK.

And sex? SSRIs are so linked to dysfunction even the pharma-identified web site WebMD admits many will experience impotence, delayed ejaculation or no orgasm. But there is a solution (besides going off SSRIs) says WebMD: Add another antidepressant that’s not an SSRI, like Wellbutrin!

Effexor, Cymbalta, Pristiq, SNRIs

Selective norepinephrine reuptake inhibitors (SNRIs) are like their SSRIs chemical cousins except their norepinephrine effects can modulate pain, which has ushered in your-depression-is-really-pain, your-pain-is-really-depression and other crossover marketing. But the problem with giving a psychoactive drug for pain is that you’re giving a psychoactive drug for pain. “After three months of taking Savella [another SNRI], I started self-destructing and cutting myself,” writes a 40 year old woman on askapatient.com. “I don’t know why or anything, but it does similar to Prozac where it makes you think and do weird things.”

And Cymbalta, approved this fall for chronic back pain and osteoarthritis?

Cymbalta was the drug healthy 19-year-old volunteer Traci Johnson was testing when she hung herself in an Eli Lilly dorm in 2005. It was the drug Carol Anne Gotbaum killed herself on at Phoenix’s Sky Harbor airport in 2007.

SNRI’s are also harder to quit than SSRIs, especially Effexor. 25-year-old Chicagoan David F. told AlterNet he stood at the top of an 8-story parking lot contemplating jumping every day for weeks after quitting. It’s also the drug Andrea Yates was on when she drowned her five children in 2001.

But not all SNRI side effects are behavioral. The FDA would not approve Pristiq, a newer version of Effexor, when Wyeth/Pfizer tried to market it for vasomotor symptoms, because it caused heart attacks, coronary artery obstruction and hypertension in clinical trials. That’s similar to another SNRI, the diet pill Meridia, which was just withdrawn from the market for causing heart problems. Pristiq is still available.

Read the rest of the article here: http://www.alternet.org/story/149078/nation_of_pill_poppers_19_dangerous_drugs_shamelessly_pushed_by_big_pharma?page=entire

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5 Myths About Depression Treatments

admin — Fri, 03 Dec 2010 20:58:18 +0000

COUNTER PUNCH, December 3, 2010

By Bruce E. Levine,
Clinical Psychologist

A warning: for people satisfied with their standard depression treatments, debunking myths about them may be troubling. However, for critically thinking depression sufferers who have not been helped by antidepressants, psychotherapy, or other standard treatments, discovering truths about these treatments can provide ideas about what may actually work for them.

Critical thinkers have difficulty placing faith in any depression treatment because science tells them that these treatments often work no better than placebos or nothing at all, and if one lacks faith in a depression treatment, it is not likely to be effective. In fact, it is belief and faith—or what scientists call “expectations” and the “placebo effect”—that is mostly responsible for any depression treatment working. Critical-thinkers can find a way out of depression when their critical thinking about depression treatments is validated and respected, and they are challenged to think more critically about their critical thinking.

Myth 1: Antidepressants Are More Effective than Placebos

Many depressed people report that antidepressants have been effective for them, but do antidepressants work any better than a sugar pill? Researcher Irving Kirsch (professor of psychology at the University of Hull in the United Kingdom as well as professor emeritus at the University of Connecticut and author of The Emperor’s New Drugs) has been trying to answer that question for a significant part of his career.

In 2002, Kirsch and his team at the University of Connecticut examined 47 depression treatment studies that had been sponsored by drug companies on the antidepressants Prozac, Paxil, Zoloft, Effexor, Celexa, and Serzone. Many of these studies had not been published, but all had been submitted to the Food and Drug Administration (FDA), so Kirsch used the Freedom of Information Act to gain access to all the data. He discovered that in the majority of the trials, antidepressants failed to outperform sugar pill placebos.

“All antidepressants,” Kirsch reported in 2010, “including the well-known SSRIs [selective serotonin reuptake inhibitors], had no clinically significant benefit over a placebo.” While in aggregate, antidepressants slightly edge out placebos, the difference is so unremarkable that Kirsch and others describe it as “clinically negligible.”

Why are so many doctors unaware of the lack of superiority of antidepressants as compared to placebos? The answer became clear in 2008 when researcher and physician Erick Turner (currently at the Department of Psychiatry and Center for Ethics in Health Care, Oregon Health and Science University) discovered that antidepressant studies with favorable outcomes were far more likely to be published than those with unfavorable outcomes. Analyzing published and unpublished antidepressant studies registered with the FDA between 1987-2004, Turner found that 37 of 38 studies having positive results were published; however, Turner reported, “Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, [falsely] conveyed a positive outcome (11 studies).”

Myth 2: If the First Antidepressant Fails, Another Antidepressant Will Likely Succeed

In The Noonday Demon, the popular 2001 book about depression, writer and depression sufferer Andrew Solomon repeated the then urban legend that “more than 80 percent of depressed patients are responsive to medication.” Solomon accurately cites a journal article that states this statistic; however, following the “reference trail,” I discovered that the journal article that Solomon cited refers to a second article for evidence of this statistic, but this second journal article mentions nothing about 80 percent of depressed patients responding to some medication.

The National Institute of Mental Health (NIMH) was aware that there was no research to back up the assertion that 80 percent of depressed patients improve if they keep trying different medications, so NIMH funded “Sequential Treatment Alternatives to Relieve Depression” (STAR*D), the largest ever study of sequential depression treatments. STAR*D results were published in 2006.

In Step One of STAR*D, all depressed patients were given the antidepressant Celexa, and in Step Two, patients who failed to respond to Celexa were divided into different groups and received other treatments (mostly different drug treatments) in place of or in addition to Celexa. If their second treatment failed, there was a third and, if necessary, a fourth treatment step.

In every STAR*D treatment step, remission rates were either equal to or significantly lower than the customary placebo performance in other antidepressant studies, but to the exasperation of many scientists, there was no placebo control in this $35 million U.S. taxpayer funded STAR*D study. (STAR*D researchers disclosed receiving consulting and speaker fees from the pharmaceutical companies which manufacture the antidepressants studied in STAR*D.)

In March 2006, NIMH triumphantly announced that 50 percent of depressed people saw remission of symptoms after the first two STAR*D steps. However, NIMH failed to mention in its press release that in the same time it took to complete these first two steps—slightly over 6 months—previous research shows that depressed people receiving no treatment at all have a spontaneous remission rate of 50 percent.

In November 2006, following the completion of all four STAR*D steps, STAR*D authors claimed a 67 percent cumulative remission rate, which again exasperated many scientists because this number failed to incorporate STAR*D’s extremely high relapse and dropout rates. In an American Journal of Psychiatry editorial that accompanied STAR*D authors’ report, J. Craig Nelson, M.D, stated, “I found a cumulative sustained recovery rate of 43 percent after four treatments, using a method similar to the authors but taking relapse rates into account.” However, even 43 percent turns out to be an inflated rate.

Separate analyses of STAR*D in 2010 by psychologist Ed Pigott and medical reporter Robert Whitaker revealed that STAR*D researchers had inflated remission numbers by switching mid-study to a more lenient measurement, and also by including patients who were not depressed enough at baseline to meet study criteria. But even taking the STAR*D data as is, Pigott’s analysis revealed that less than 3 percent of the entire group of depressed patients who began the STAR*D study can be ascertained as having a sustained remission (i.e., actually participated in the final assessment without relapsing and/or dropping out).

Myth 3: Electroconvulsive Treatment (ECT) is an Effective Last Resort

Andrew Solomon in The Noonday Demon alsostates, “ECT seems to have some significant impact between 75 and 90 percent of the time. About half of those who have improved on ECT still feel good a year after treatment.” Is ECT really that effective?

In 2004, researcher Joan Prudic, M.D. and her team at New York State Psychiatric Institute conducted a major study of ECT, which involved 347 patients at seven hospitals. Reported were both the immediate outcomes and the outcomes over a 24-week follow-up period. With respect to immediate outcomes, Prudic reported: “In contrast to the 70 to 90 percent remission rates expected with ECT, remission rates, depending on criteria, were 30.3 to 46.7 percent.” Even worse for ECT advocates, Prudic noted that, “10 days after ECT, patients had lost 40 percent of the improvement.”

There are also studies comparing ECT with a placebo (called “sham ECT”). In sham ECT, patients receive muscle-relaxing and anesthetizing drugs that routinely accompany ECT, and they are hooked up to the ECT apparatus, but they receive no electric voltage. Psychiatrist Colin Ross reports, “No study has demonstrated a significant difference between real and placebo (sham) ECT at 1 month post-treatment.”

Myth 4: Cognitive Behavior Therapy (CBT) is the Best Psychotherapy for Depression

First, the good news about CBT. The only non-drug treatment examined in STAR*D was a form of cognitive therapy (which was not fully detailed by STAR*D authors and only administered in Step Two). Among those who failed Celexa in the first step, three groups in Step Two switched from Celexa to one of three antidepressants, and their remission rates ranged from 25 to 26.6 percent; but one group in Step Two switched from Celexa to cognitive therapy, and its remission rate was 41.9 percent. STAR*D researchers did not assess whether any differences in treatment effectiveness were statistically significant.

Another group in Step Two maintained Celexa and added cognitive therapy, and this “Celexa plus cognitive therapy” group’s remission rate was 29.4 percent, not as high as the group that received cognitive therapy without medication. This begs the question: Is it also a myth that “antidepressants plus psychotherapy” works better than either treatment alone? Research psychologist David Antonuccio at the University of Nevada School of Medicine reports, “Combined psychotherapy and drug treatment do not appear to be superior to therapy or drug treatment alone.”

What psychotherapy is best for depression? While Americans hear most about CBT, it turns out that CBT or some form of cognitive therapy is no more effective for depression than any of several other types of psychotherapy. In 2008, psychologists Pim Cuijpers and Annemicke van Straten at the University of Amsterdam reported on a meta-analysis of 53 studies, each of which compared two or more different types of psychotherapy for depression. Included were varieties of “cognitive-behavior therapy,” “psychodynamic therapy,” “behavioral activation therapy,” “social skills training,” “problem-solving therapy,” “interpersonal therapy,” and “nondirective supportive therapy.” The major finding? “No large differences in efficacy between major psychotherapies for mild to moderate depression.”

So, if psychotherapy technique is not all that important, what is? Psychologist Bruce Wampold at the University of Wisconsin reviewed the psychotherapy outcome literature, examining hundreds of studies and meta-analyses, for his book The Great Psychotherapy Debate. Wampold unequivocally states that outcome effectiveness does not depend on the specific techniques of psychotherapy but instead depends on so-called “non-specific” factors such as the nature of the alliance between therapist and their client, and clients’ confidence in the therapy and in their therapist. “Simply stated,” Wampold concludes, “the client must believe in the treatment or be led to believe in it.”

Myth 5: No Treatment for Depression Works

In April 2002, an NIMH-funded study on the antidepressant Zolof, the herb St. John’s wort, and a placebo had some curious results. The findings were that 32 percent of placebo-treated patients experienced remission, better than the 25 percent remission for the Zoloft-treated patients or the 24 percent remission for the St. John’s wort-treated patients. Most scientists would say that this study shows that neither Zoloft nor St. John’s wort worked, but those subjects who had positive outcomes with these two treatments would disagree. So, does this study show that antidepressants and St. John’s wort are not helpful, or does it show that “expectations,” belief,” and “faith” are the likely factors that make all treatments work?

When assessing whether a specific treatment is effective, scientists are trained to rule out the effect of expectations. Researchers evaluate a depression treatment as effective if, in a controlled study, the treatment outcome is significantly better than a placebo. However, the reality of depression treatments is that expectations, faith, belief, and the placebo effect are—far and away—the most important reasons why anything works.

Read the rest of the article here: http://www.counterpunch.org/levine12032010.html

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Wyeth Execs Can’t Hide Behind Silence on Antidepressant Data

admin — Wed, 01 Dec 2010 21:04:35 +0000

BNET – December 1, 2012

Image by Francesco Marino

by Jim Edwards

A lawsuit that alleges Wyeth executives told a series of lies about the antidepressant Pristiq — suggesting that it was a good treatment for post-menopause hot-flashes when they were sitting on study data showing a risk of heart and liver problems — gives new guidance to management on what counts as a false or misleading disclosure to investors.

In the case, the judge ruled that front-loading your investor presentations with a bunch of boilerplate language about “safe-harbor” predictions and “forward-looking statements” that ought to be treated with caution does not allow you to stay silent about negative data that you know will affect the fortunes of your company. (The order was reaffirmed just before Thanksgiving.)

A pension plan that was invested in Wyeth stock (before it merged with Pfizer (PFE)) alleged that Wyeth CEO Bernard Poussot and others knew by 2005 that using Pristiq for post-menopausal vasomotor symptoms (hot flashes) carried increased risks of liver and heart damage. The ruling says:

Of the 707 participants [in a Phase III clinical trial], 27 suffered serious adverse effects (“SAEs”), including three coronary occlusions and two heart attacks.

No one taking the placebo experienced a serious adverse event. Wyeth did not reveal this data to investors, however, and instead applied to the FDA for approval to market the drug as if nothing was wrong.

At the time, Pristiq was crucial to Wyeth’s fortunes. It previous antidepressant, Effexor, was losing its exclusive patent protection and the company’s two post-menopause drugs, Prempro and Premarin, turned out to be associated with blood clots and cancer. If the company could get Pristiq approved for hot flashes, it would be a double-blockbuster.

In 2007, however, Wyeth announced that the FDA turned down Pristiq for hot flashes. Wyeth’s stock dropped more than 10 percent, losing $5.70 per share.

Between learning of the negative data in 2005 and the FDA’s thumbs down in 2007, Poussot’s team fed investors a stream of upbeat chatter about the likelihood of getting Pristiq approved for post-menopausal women:

February 9, 2006, Merrill Lynch Pharma Conference, CFO Kenneth Martin: The opportunity clearly is there. The market clearly is there. And if the profile of the product is where we hope it be, we think this is a –- this could be a very big opportunity. … This is a drug that we’re very optimistic about.

October 5, 2006, annual investor conference, svp/president Joseph Mahady: [Pristiq] begins to really differentiate itself with its ability to reduce the frequency and severity of moderate to several [sic] vasomotor symptoms associated with … menopause. … [W]e predict that Pristiq has the potential to exceed $2 billion in peak sales, and that’s the cost of the two indications that we’ve spoken about, MDD and VMS.

At the same conference, svp R&D Robert Ruffolo: We think that [Pristiq] will also be important for the vasomotor indication where – it would obviously be our intent for this drug to be used as another option for women who are suffering from vasomotor symptoms, which is the number one reason women will go to the doctor to seek treatment. … In fact, the way Pristiq looks like it’s positioning itself right now, it’s a drug primarily for women’s health.

Wyeth’s defense was that safe harbor statements about future predictions ought to be treated with caution as “forward-looking statements” — i.e. all the legal disclaimers you see in front of every investor presentation — so Wyeth could not have predicted the FDA’s decision.

The judge agreed with that, but he then ruled that managers’ statements about Pristiq’s safety were not forward-looking because Wyeth already had all the safety data in hand when the statements were made.

Wyeth also argued that the adverse events were not statistically significant, and that they were disclosed at a poster-session at an ob-gyn conference and in a single analyst’s note to investors. The judge dismissed both of those arguments, as statistical significance is an issue of fact to be decided by a jury not a matter of law, and because the conference poster disclosure was too minimal to count as a disclosure to investors.

The case is a warning from the federal judiciary that sometimes CEOs and their lieutenants go too far in concealing negative data. Recently, the federal judiciary has sided with executives who lie to investors and to the federal government. Nonetheless it appears there is still a limit to judges’ sympathy for managers who have difficulty disclosing the whole truth.

http://www.bnet.com/blog/drug-business/wyeth-execs-can-8217t-hide-behind-silence-on-antidepressant-data/6592

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