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4 Creepy Ways Big Pharma Peddles its Drugs

Tuesday, January 10th, 2012

Big Pharma uses ads that sow hypochondria, raise health fears and sell diseases to adults and their children.

Alternet
By Martha Rosenberg
January 9, 2012

It’s no secret that advertising works. Big Pharma wouldn’t spend over $4 billion a year on direct-to-consumer advertising if it didn’t mean massive profits.

What is more unknown is why drug ads that sow hypochondria, raise health fears and “sell” diseases are often the most common–and effective–even when the drugs themselves are of questionable safety.

The nation’s fourth most frequent drug ads in 2009 for were Cymbalta, making Eli Lilly $3.1 billion in one year, despite the antidepressant’s links to liver problems and suicide. Pfizer spent $157 million advertising Lyrica for fibromyalgia in 2009, despite the seizure pill’s links to life-threatening allergic reactions. The same year, it spent $107 million advertising the antidepressant Pristiq, even though it also had links to liver problems.

So, how does Pharma dupe us into using unsafe drugs? Today’s drug ads, targeted directly to consumers since 1999, seem like they sell diseases and often cast women, children, the elderly and mentally ill in a bad light. But a quick look at ads before direct-to-consumer advertising (DTC) in medical journals shows that drug ads have always done so. It’s just that patients didn’t used to see them.

Here are some of Pharma’s most offensive ad campaigns, then and now.

1. You’re Sicker Than You Think

When psychiatric drugs first became popular for use in the general population, in the late 1960s, everyday personality problems became imbued with psychiatric labels. “Lady, your anxiety is showing (over a coexisting depression),” says a 1970 ad, showing an older, wrinkly woman in a bouffant wig with gigantic sunglasses and garish jewelry. “On the visible level, this middle-aged patient dresses to look too young, exhibits a tense, continuous smile and may have bitten nails or overplucked eyebrows,” says the ad copy. “What doesn’t show as clearly is the coexisting depression.”

The ad, both sexist and ageist, suggests the woman needs the antidepressant and tranquillizer Triavil.

Another ad from 1968 shows a bored, upper-middle-class couple whose hauteur is also said to really be depression. “Do you have patients who try to hide frustration behind conformity?” says the ad for the antidepressant Aventyl HCl.

You’d think such demeaning ads would vanish with DTC advertising because people would be offended. But You’re Sicker-Than-You-Think ads are alive and well since DTC advertising and even flowering.

A three-page consumer ad in the late 2000s similarly conveys that everyday psychological traits could actually be dire mental problems that require medication. If you are “talking too fast,” “spending out of control,” “sleeping less,” “flying off the handle” and “buying things you don’t need,” you could be suffering from bipolar disorder said the ads, which appeared in magazines like People. And here you thought it was the coffee. Accompanying photos of a woman screaming into a phone and contorting her face are so extreme they could come out of the movie Halloween Part II, if the woman were holding a knife.

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Psychiatric drugs are not just advertised for everyday personality problems. Pharma is pushing them for everyday pain conditions. Eli Lilly’s original depression campaign for the antidepressant Cymbalta, “Depression Hurts,” seems to anticipate its subsequent approval for pain conditions including back problems. Now ads tout Cymbalta as a “non-narcotic, once daily analgesic FDA approved for three indications across four different chronic pain conditions,” as if it does not have severe controversial psychiatric risks including the suicide of volunteers who tested it.

And seizure and epilepsy drugs, known for major allergic and psychiatric reactions, are also becoming pain franchises. “What’s causing your chronic widespread muscle pain?” asks an ad for the seizure and epilepsy drug Lyrica. “The answer may be overactive nerves,” says the ad, even though “widespread muscle pain” and “over-active nerves,” are not mentioned in the approved labeling for Lyrica, says pharmaceutical reporter John Mack. The military spent $35 million on seizure and epilepsy drugs in 2009 alone, including for migraines, headaches and pain.

And speaking of overkill, ads for genetically engineered injected drugs like Humira, approved to treat serious diseases like Crohn’s disease, psoriatic arthritis and chronic plaque psoriasis look like they are designed to sell beer or beauty treatments, not immune suppressing drugs that invite cancers and lethal infections.

DTC ads don’t just escalate everyday problems into psychiatric problems, they also escalate real psychiatric problems into irresponsible, sensationalistic stereotypes. Ads for the best-selling antipsychotic Risperdal, widely used in children, and in soldiers with PTSD, suggest that people with mental illness have hallucinatory fears about “boiling rain” and “dog women.” The “dog woman” ad, showing a half-dog, half-woman crouched on her elbows, her eyes blackened, furthers the sensationalizing of mental illness with the tagline, “Because relapses are a living nightmare.”

2. Your Kid Is Sick 

DTC ads don’t just convince people they’re in need of new drugs, but also that their kids may be, too. And it’s been going on for decades.

Long before Pharma convinced parents, teachers and clinicians that millions of US kids had attention deficit hyperactivity disorder (ADHD), kids were said to suffer from “minimal brain dysfunction” (MBD) and “hyperkinesis,” two conditions that were essentially the same as ADHD. In fact, so many kids had MBD by 1976 that an ad for the drug Cylert hailed the “Importance of single daily dose to the child, the parents and the teacher,” because kids wouldn’t have to be singled out anymore at pill time at school. (ADHD has been so huckstered, a YMCA ad spoofs it with the headline, “Before video games, before Facebook, before Ritalin, there was basketball.”)

Yet neither Cylert–whose approval the FDA withdrew in 2005 because of liver failure and deaths–or the current ADHD drugs are safe. In 2009, researchers reported that kids are more likely to die sudden deaths while taking them and the American Heart Association recommends electrocardiograms (ECGs) before kids take them. And yet, combined sales of ADHD drugs continue to grow from $4.05 billion to $7.42 billion in 2010.

Thirty years ago, it certainly looked like kids were being overmedicated. They were given the antipsychotic Thorazine for their “hyperactivity,” “hostility,” sleep problems and even for vomiting. Picky eaters and kids who wet the bed were given tranquillizers. Kids with tics, stuttering and school phobia were given the tranquillizer Miltown.

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But today, ads promoting drugs for kids continue, and now they are aimed at parents. Sometimes, it’s hard to tell the difference between ads for drugs or ads for sugary cereals! Pharma tells moms to give their kids the bubble gum-flavored ADHD med, LiquADD and the grape-flavored ADHD med, Methylin. The latter campaign, to parents, is “Give ‘em the GRAPE!”

DTC advertising has also convinced parents their kids suffer from GERD (gastroesophageal reflux disease) otherwise known as acid reflux disease, which was barely a disease in adults much less kids, before consumer advertising. “GERD Can Be a Big Problem for Little Kids,” say award-winning ads for Prevacid, which won a “RX Club” Silver award in 2004. In Europe, kids are treated for another “adult disease” and given chewable Liptitor to lower their cholesterol.

Some of Pharma’s most aggressive advertising has been designed to convince parents their children’s minor sniffles or wheezing are imminent asthma and require immediate and expensive drugs. To make the asthma drug Singulair (which also comes in a yummy chewable), the seventh most popular drug in 2010, Merck inked partnerships with the American Academy of Pediatrics and Scholastic, both of which parents consider neutral organizations and not Pharma mouthpieces. Merck also partnered with Olympic gold-medalist swimmer Peter Vanderkaay and NBA kid clubs to sell the asthma drug.

“A kid who’s got what your kid’s got is out doing what your kid’s not,” says one Singulair ad campaign. “Find out how you can help your child breathe a little easier.”

If Singulair were not harmful, the huckstering would simply be a case of wasting money and overmedicating kids. But Singulair has been linked to both pediatric suicide and to emotional, behavioral and ADHD-like symptoms in kids, the latter likely inspiring parents to give their kids “the grape.”

Of course, another kid-targeted campaign is for the vaccine against the sexually transmitted Papillomavirus or HPV, immortalized by Gov. Rick Perry and Rep. Michele Bachmann in hot exchanges this fall. Many object to the sexualizing of 9-year-olds, to government lining Pharma’s pockets by promoting the vaccine (including overseas) and to the risks of the vaccines themselves. But the ads for Gardasil and Cervarix are also offensive.

Last spring, poster-sized ads for Gardasil on Chicago’s commuter trains pretended to sell real estate in sought-after neighborhoods. A closer look revealed descriptions of women in those neighborhoods who thought they didn’t need the HPV vaccine but did, positioning HPV not only as a general risk to the population, like flu, rather than an STD but as “hip.”

HPV vaccine ads got even cooler when GSK rolled out Cervarix extravaganza TV ads and its “armed against cervical cancer” campaign with an Angelina Jolie-like model displaying a skinny arm with a Cervarix tattoo.

3. Be Like Me, and Can Your Beer Do This?

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Prescription drugs may affect health, but they are still consumer products sold with the same marketing principles as toothpaste or beer. In fact, the wacky, “Can Your Beer Do This?” Miller Lite campaign of the 1990s, came back to life to sell the antidepressant Wellbutrin XR. In a glossy, color magazine ad, a young man rows his girlfriend on a scenic lake and lists the benefits of his Wellbutrin XR. “Can your medicine do all that?” he asks.

What does it say about the success of DTC advertising that people are assumed to have an antidepressant?

Experiential ads also sell prescription drugs like vintage ads for the “Kodak Moment,” “Maalox Moment” and the old cigarette ads for the “L&M Moment” did. “Lunesta Sleep. Have You Tried it?” asks a 2007 ad in Parade magazine, elevating the experience to something akin to “designer sleep.”

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And just as celebrities move other consumer products, they have been deployed to sell prescription drugs. TV personality Joan Lunden and former baseball star Mike Piazza stumped for the allergy pill Claritin, ice skater Dorothy Hamill and track star Bruce Jenner for the pain pill Vioxx, and Sen. Bob Dole for Viagra. NASCAR figure Bobby Labonte also endorsed the antidepressant Wellbutrin XL in 2004. Yes, his medicine could “do all that.”

But there has been a problem with celebrity drug endorsements, unlike product endorsements in which a celebrity like Tiger Woods or Martha Stewart could taint a product, a prescription drug can taint a celebrity! Did Dorothy Hamill know that Vioxx doubled the risk of heart attacks in users when she stumped for it? Did the model Lauren Hutton know that hormone replacement therapy causes a 26 percent higher incidence of breast cancer, a 29 percent increase in heart attacks, a 41 percent increase in strokes, and a doubling of the rate of blood clots when she shilled for it? Does actress Sally Field know that bone drugs like Boniva are linked to esophageal cancer, jaw bone death and the very fractures they are supposed to prevent as she pushes them?

Of course, good product marketing includes public relations. When Pharma sells a disease with no mention of the drug it is really selling, it’s called “unbranded” advertising. Since DTC advertising, Pharma has invaded public service announcements (PSAs) that TV and radio stations confer for free, pretending their take-a-drug messages serve the public good, like messages to change smoke detector batteries or put kids in car seats.

One such “educational” “awareness” campaign called “Depression Is Real” saturated the radio air waves in 2011, funded by the National Alliance on Mental Illness, which was investigated by Congress for its Pharma funding from Wyeth, part of Pfizer, and other groups. The high-budget ads, running for free, compare depression to diabetes because it doesn’t go away and to cancer because it can be fatal.

4. One Kind of Ad You Won’t See Anymore

Animal research at drug companies and the National Institutes of Health is a great scientific iceberg of which people only see a tip. In drug development, millions of animals die to prove a drug’s “safety.” At academic and medical centers, animal study grants from NIH provide millions to researchers and labs.

As sentiment grows against animal experiments and the government’s gigantic National Primate Research Centers (new rules will limit the use of chimpanzees), the research is downplayed and even hidden. But there was a time when Pharma actually flaunted animal research.

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“More than a decade of animal research on various animal species has suggested that Librium (chlordiazepozxide HCI) exerts its principal effects on certain key areas of the limbic system,” says an ad from the 1970s, showing three monkeys crouching and dangling in cages as assorted experiments are conducted.

An ad for the diet pill Pre-Sate is even worse. It says, “one of the most sophisticated comparative animal studies ever conducted demonstrates direct action on the satiety centers,” and shows five photos of cats in experiments. One shows a life-size white cat looking at the camera with a chain around its neck and invasive instrumentation embedded in its skull.

Today’s consumers, it seems, wouldn’t tolerate ads like these. (Or the experiments behind them.) Why do they tolerate derisive ads about “dog women” and ploys to market pharmaceuticals to kids as if it were candy?

http://www.alternet.org/drugs/153677/4_creepy_ways_big_pharma_peddles_its_drugs?page=entire

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Online database lets you research the side effects of common psychiatric drugs

Thursday, September 15th, 2011

Natural News – September 15, 2011

by M.K. Tyler

(NaturalNews) If you have ever seen a commercial for a pharmaceutical drug, you are probably familiar with the long list of dangerous side effects that are rattled off in the last five seconds of the advertisement, just after viewers are told how Drug “X” is going to save their lives, improve their memories or give them unlimited energy. What was that? Did he just say that pill might cause bleeding out of my eyes?

Drug companies do a great job – and spend a lot of money – to ensure that most consumers aren’t aware of the harmful side effects of common drugs prescribed for conditions like depression, heart disease, arthritis, ADHD or high blood pressure. Unfortunately, the result of this has created a society where the average person with a health problem is captivated by the promises delivered in clever advertising. There is a drug for everything? All I have to do is talk to my doctor? How convenient.

But what if there was a way to take back control of our lives and our health? What if, despite talking to your doctor, you still have questions or concerns about the safety of a drug?

The Citizens Commission on Human Rights International (CCHR) has a database that allows you to do just that. It’s called the Psychiatric Drug Database, and it allows consumers to research the potential side effects of common psychiatric drugs, such as Ritalin or Wellbutrin.

While the database is limited to psychiatric drugs, this type of public information portal represents a significant step in the right direction to help patients find unbiased information and make informed decisions about their health.

The database allows you to search by drug and will retrieve information about adverse reactions reported by patients who have taken the drug, international warnings and studies that have been done on the drug and what side effects different age groups or genders have experienced. For example, a search of the effects of Ritalin on 18-30 year old women retrieved 89 reported cases of adverse side effects.

These effects including anxiety, fatigue, hypertension, tremors, chest discomfort, nausea, panic attacks, cardiac murmurs, aggression, suicide attempts and completed suicides. The results are broken down by case and list specific symptoms and reactions caused by the drug in each reported case.

Another search of Zoloft and its effects on young children included cases of cerebral disorders, upper respiratory tract infections, sleep disorders, vertigo, hallucinations, psychomotor hyperactivity and suicidal ideation.

The database only includes information on cases that were actually reported to the FDA’s Adverse Event Reporting System between 2004 and 2008. Based on the FDA’s own estimates, only about 1 to 10 percent of adverse drug side effects are even reported to the FDA. The CCHR’s database, therefore, represents only a small margin of the population that has been affected by adverse side effects of pharmaceutical psychiatric drugs.

Visitors to the site will also notice an interesting anecdote that describes how the definition of poison – a substance that causes death or harm when consumed by a living organism – clearly characterizes the drugs listed in the database. Consumers are encouraged to research potential problems of a drug before agreeing with their doctors to start a course of therapy.

To find more information about a particular drug, visit www.cchrint.org/psychdrugdangers

Sources for this article include

http://www.cchrint.org/psychdrugdan…

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Interview with “Psychiatryland” Author, Phillip Sinaikin, MD

Monday, July 25th, 2011

Scoop News – July 25, 20011

By Martha Rosenberg

"Psychiatry mimics science but is not a real science. The symptoms it treats are subjective and have not been demonstrated and cannot be demonstrated at the cellular level."

Phillip Sinaikin, MD, is a Florida psychiatrist who has been in practice for 25 years. His new book focuses on excesses and industry influence in the field of psychiatry.

Rosenberg: Your new book, Psychiatryland, traces how deception, conflicts of interest, medical enabling and direct-to-consumer advertising have resulted in millions being on psychiatric drugs they don’t need. One patient you describe has legitimate mourning and grief work to do after his wife leaves him for his own cousin. But his grief is pathologized into “bipolar disorder” by the system, including his own mother.

 Sinaikin: By the time I saw this patient, he was on Wellbutrin and another antidepressant, the mood stabilizers Eskaltih and Keppra, the antipyschotic Abilify, the tranquilizer Klonopin and Adderall for ADD. Calling grief a psychiatric disorder deflates and dishonors the spiritual dimension of loss and grief and the sadness which is a marker of the lost love. By the time this patient came under my care (three years after the loss of his wife) his “case” had become such a jumbled, incomprehensible and irrational mess of overdiagnosis and overmedication that the only word I can use to describe it is CRIMINAL.

Rosenberg: Can you explain the popularity of such drug cocktails? The drugs haven’t been tested together so the patient is a guinea pig. And their total cost can exceed $1000 per month, often shuttled onto taxpayers because the people are considered disabled under federal entitlement programs.

Sinaikin: Psychiatry mimics science but is not a real science. The symptoms it treats are subjective and have not been demonstrated and cannot be demonstrated at the cellular level. That gives psychiatrists free reign to just experiment and symptom chase, often insanely chasing the side effects and negative interactions of the current drug regimen with more and more drugs. Polypharmacy is also a way psychiatrists can distinguish themselves in an increasingly competitive market. No one believes you need a specialist for one drug — any primary care physician can give you Zoloft — but for multi-drug therapy you do. If you don’t write a prescription as a psychiatrist, you won’t work these days. It is like being a pacifist and having no choice but working in a bullet factory.

Rosenberg: A lot of this trial-and error polypharmacy is buttressed by the concept of “treatment resistance” and “Prozac poop-out.”

Sinaikin: I write in the book that an antidepressant not working anymore is no different than getting used to anything that used to thrill us. We buy our dream house with two bedrooms and a garage and after a while it doesn’t make us happy anymore and we are eyeing the house with three bedrooms and a pool. Another example, of course, is falling in and out of love.

Rosenberg: You document in Psychiatryland the creation of new diseases to sell drugs including adults now diagnosed with childhood disorders like ADD and children with adult disorders like bipolar and depression.

Sinaikin: One scientific article I read about the new childhood disorders sounds like a satire. Two well-respected “thought leaders” in psychiatry were debating the underlying pathology of a three-year-old girl who ran out in traffic. The first doctor believed her dangerous behavior was indicative of an Oppositional-Defiant disorder. The other doctor argued her impulsive act represented grandiose delusions where this girl believed she was special and cars could not harm her. She was, therefore, bipolar.

Rosenberg: Another shocker in your book is how everyday drug and alcohol addicts were recast as having psychiatric conditions for money.

Sinaikin: The insurance companies told the rehabs they would no longer pay for inpatient rehab for heroin, cocaine or alcohol unless there was also another Axis 1 psychiatric disorder like bipolar disorder or major depression. I was working in a drug treatment facility when the change happened. Since addicts typically complain of anxiety and depression, a completely understandable emotional response to their toxic lifestyles, it was “no problem” to add a new label and throw a few psychiatric drugs at their now relabeled “dual diagnosis.” Of course the central tenet of recovery, taking personal responsibility, was buried by the new victim narrative of self-medicating a previously undiagnosed mental illness.

Rosenberg: Treating addiction with psychiatric drugs before or instead of seeking a higher power is antithetical to the 12 Steps of Alcoholics Anonymous.

Sinaikin: As I say throughout my book, human beings are indescribably complex. There are times when the dual-diagnosis concept is necessary and helpful but clearly not applicable to 100% of the cases of addiction as it is now applied. I believe that the 12 Step model is an ideal model of recovery. Patients can have the help whenever they are truly ready, not just when someone decides to foist it on them. Most importantly, the addicts helping other addicts are doing it to facilitate their own recovery and not for ulterior motives such as money. Amazingly, in a world gone profit crazy 12 Step recovery programs are still free. I conceptualize the 12 Steps as a distillation of the spiritual principles world’s great religions but no one is forced to believe in anything including God.

Rosenberg: Given conflicts of interest at the American Psychiatric Association, which drives psychiatric diagnoses, in the FDA drug approval process itself and the legions of doctors willing to huckster for pharma as thought leaders or Key Opinion Leaders (KOLs), do you see any hope of rescuing people from Psychiatryland?

Sinaikin: The system is unbelievably bad and even worse than it looks. But, I think a goal that could be achieved would be a repeal of direct-to-consumer advertising. Patients now come into my office asking me if they have ADD or bipolar disorder or if they can have Cymbalta. When I began practicing psychiatry, long before direct-to-consumer advertising, this would never have happened.

Psychiatryland

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The Small Group of Thoughtful, Committed Citizens Has Been Drugged

Tuesday, May 24th, 2011

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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Wellbutrin – To Promote or Not Promote… That is the Question

Friday, May 6th, 2011

Seroxat Sufferers – Stand Up and Be Counted
By Bob Fiddaman
May 6, 2011

Did they or didn’t they?

Lauren Stevens, the Glaxo associate general counsel, who is charged with one count of obstructing an official proceeding, one count of falsifying documents before a federal agency and four counts of making false statements to the FDA, has heard evidence given to a jury by James Millar, GSK vice president of strategic pricing, contracting and marketing.

Millar had originally refused to testify but prosecutors persuaded the US District Judge [Roger W. Titus] to order him to give his testimony.

Millar was head of GSK’s marketing for Wellbutrin and remained insistent that GSK’s promotion of its product was as an antidepressant that carried low risk of weight gain and sexual dysfunction.

GSK have claimed that they worked with doctors to stop the promotion of Wellbutrin for off label use.

In 2002, writes Law 360′s Christopher Norton, “GSK became aware that the company’s two top promotional-speaker doctors were using slides in their presentations including information for off-label uses of the drug, but swiftly took steps to bring the pair into compliance with all regulations.”

Those top two doctors were named as Psychiatrist James Hudziak and physician James Pradko, they were both the most highly paid doctors in GSK’s Wellbutrin promotional stable.

It was Millar who, alongside others at GSK, worked with doctors that GSK, claimed, paid to promote the drug in an effort to ensure the physicians removed any mention of off-label uses from their presentations, especially in the wake of new regulations that began to roll out around 2002, he told the jury, writes Christopher Norton for Law360.

It is alleged that Lauren Stevens lied to the FDA when they sought information from GSK about whether or not they promoted Wellbutrin for weight loss. It’s also alleged that Stevens knew GSK had sponsored programs that promoted Wellbutrin as a weight loss drug. Stevens is also alleged to have known that GSK had paid many doctors to promote Wellbutrin to other doctors which included “off-label” use.

Millar claims that he was sent to monitor Psychiatrist James Hudziak after concerns were raised about his potential use of off-label slides, slides he used at presentations. Millar was apparently able to make Hudziak change the presentation and got him to start using a “company approved” slide kit.

Stevens has claimed that she concealed slides from the FDA showing that GSK was promoting Wellbutrin for illegal unapproved use, she has also claimed that she was advised by a company lawyer to do so.

So, we have GSK saying they did everything in their power to stop doctors promoting the illegal, unapproved use of Wellbutrin… yet we have Stevens, as part of her defence, claiming she concealed slides that showed GSK was promoting Wellbutrin for illegal unapproved use. Not only that – she was told to do so by one of GSK’s lawyers!

The mind boggles at how this company operate.

It seems that Stevens, the former Glaxo associate general counsel, is now turning against the very same people she used to work for. You go girl.

The case against Stevens continues.

Her re-indictment can be viewed HERE

Read article here:  http://fiddaman.blogspot.com/2011/05/wellbutrin-to-promote-or-not.html

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Feds Want Glaxo Exec To Testify In Stevens Case

Monday, April 25th, 2011

Pharmalot – April 25, 2011

By Ed Silverman

gavel-flickr4The trial of former GlaxoSmithKline lawyer Lauren Stevens gets under way this week and federal prosecutors hope to force a Glaxo exec to testify, according to documents filed in federal court last week. The feds are trying to compel James Millar, a vp of strategic pricing, contracting and marketing to take the stand in their quest to convict Stevens of obstruction of justice.

Stevens, you may recall, was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. More recently, the indictment was tossed, because prosecutors incorrectly portrayed her defense to a grand jury. However, they subsequently issued another indictment earlier this month (back story).

The feds want Millar to be compeled to testify because his testimony “may be necessary to the public interest.” However, prosecutors expect that he would refuse to testify or otherwise provide any info on the basis of his privilege against self-incrimination, according to court documents (read this). As of this morning, the order compelling his testimony has not been filed with the court.

As indicated previously, the trial threatens to evolve into a spectacle where Glaxo execs and Glaxo lawyers – notably, the King & Spalding law firm that frequently represents the drugmaker – turn the courtroom into a finger-pointing match among people who once labored on the same side of the pharmaceutical battlefield (see here).

http://www.pharmalot.com/2011/04/feds-want-glaxo-exec-to-testify-in-stevens-case/

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Panel to Examine Murder and Suicide Associated With Antidepressants

Tuesday, March 22nd, 2011

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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Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New Jersey – Drinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

Oklahoma – Kaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

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A sugared pill

Wednesday, March 9th, 2011

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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Dealing With Depression Naturally

Tuesday, March 8th, 2011

FOX News, March 8, 2011
by Chris Kilham

If your life is making you unhappy, then making positive changes may be the very best prescription of all

According to a study published in the Archives of General Psychiatry, approximately 10 percent of Americans are taking antidepressant medications.

This means that over 31 million Americans are gobbling Prozac, Zoloft, Celexa, Elavil, Norpramin, Luvox, Paxil, Wellbutrin and other antidepressant psychiatric drugs like M & M’s. This drug use accounts for billions of dollars in pharmaceutical sales annually (9.6 U.S. billion in 2008).

Yet according to a landmark study published in the Journal of the American Medical Association, antidepressant medications work – as well as placebos and not more. In other words, people in depression studies who are given sugar pills instead of antidepressant drugs do as well as the group who gets the drugs.

Before you ask yourself whether you should simply take a Tic Tac instead of a Paxil, there is more disheartening news about these drugs. Many Americans are taking antidepressant medications instead of changing their own behavior or life circumstances. According to Maryland medical doctor Ronald Dworkin, “Doctors are now medicating unhappiness. Too many people take drugs when they really need to be making changes in their lives.” If you are beating your nose with a hammer, do you stop hitting yourself, or do you continue, and take a pain pill?

Digging more deeply into the mystery of antidepressants, George Washington University health analyst Thomas Moore examined unpublished studies conducted by drug companies  with various antidepressants. Approximately 40 percent of the studies conducted on this class of drugs have never been published — because in those 40 percent of studies, antidepressants do not demonstrate effectiveness. In other words, in the unpublished studies, they didn’t work. In even further research, Irving Kirsch of the University of Connecticut looked at results from varying doses of antidepressants. The difference in effectiveness between small doses and large doses was virtually non-existent.

It gets even gloomier. A U.S. government study released in 2006 showed that fewer than 50 percent of people become symptom-free on antidepressants, even after trying two different medications. Many who do respond to medication slip back into major depression within a short while, despite sticking with drug treatment. And then there are the “side effects,” which are really effects pure and simple. The most common effects of antidepressant drugs include nausea, insomnia, anxiety, restlessness, loss of sex drive, dizziness, weight gain, tremors, sweating, sleepiness, fatigue, dry mouth,  diarrhea, constipation and headaches. People over 65 are at extra risk of falls, fractures and bone loss, newborns of mothers on SSRI antidepressants can go through drug withdrawal, and among teens, the use of antidepressants can increase suicidal tendencies. Any sober assessment of these effects points to the fact that there is something terribly wrong with this entire class of drugs. Remember what Hippocrates said “First of all, do no harm.”

Many intangibles add up to either a happy life or a sad one. Do you spend enough time with your family? Your friends? Do you relax? Do you do things you love? Do you enjoy your work? If you answer no to these questions, you probably have good cause to feel depressed. But popping a pill won’t help if you are not living in a fulfilled way.

What about natural approaches to depression? A number of doctors believe that nutritional deficiencies play a key role in many cases of depression. After all, brain chemistry depends on nutrient intake for proper balance. Really, it’s no surprise that a junk food-eating culture would be increasingly mentally out of sorts. No brain food means poor brain function. This is where omega 3 fatty acids come in, notably DHA, which is essential for proper brain function. These essential fats greatly enhance brain health and mood. The best way to get them is to eat fresh seafood, especially wild salmon. But omega 3 fatty acid supplements from fish oil are also available.

According to the National Institutes of Mental Health, anxiety and depression often go hand in hand. Many people find that they can relieve or reduce anxiety by meditating. There are many ways to meditate. By setting aside time every day, you can calm your body and mind, change your brainwaves, and alter your mood for the better.

Regular exercise is also associated with improved mood. Exercise enhances circulation, modifies brain chemistry for the better, enhances overall energy, improves vitality and contributes greatly to well being. You don’t need to go to a gym, either. Just get outside and walk. Do so briskly for at least half an hour each day, and notice how much better you feel.

On the herbal side, Rhodiola rosea is the big antidepressant. Many forward-thinking psychiatrists have turned to Rhodiola as a first line of treatment, instead of pharmaceuticals. Psychiatrists Richard Brown and Patricia Gerbarg in New York are ardent advocates of Rhodiola for depression and mood enhancement, and have written profusely about it. Dr Hyla Cass of UCLA also is an advocate. Meanwhile, dozens of studies demonstrate significant improvement in all parameters of mental function with Rhodiola rosea. My favorite brands? Rhodiola Energy by Enzymatic Therapy, and Rapid Rhodiola by EuroPharma.

If your life is making you unhappy, then making positive changes may be the very best prescription of all. Many people are so buried by work and stress that they forget to take time to live, to enjoy themselves and to savor life itself. I remember once meeting a psychiatrist at one of my talks. He was retired, and I was deeply impressed by what he shared.

“I practiced psychiatry for twenty-eight years,” he said. “And I never once gave anybody a prescription.” I asked him what he did for his patients instead.

“I talked with them,” he replied. As Rabbi Earl Grollman, author of several books on grief says, “the mentionable is manageable.” Maybe talking is a good place to start.

Chris Kilham is a medicine hunter who researches natural remedies all over the world, from the Amazon to Siberia. He teaches ethnobotany at the University of Massachusetts Amherst, where he is Explorer In Residence. Chris advises herbal, cosmetic and pharmaceutical companies and is a regular guest on radio and TV programs worldwide. His field research is largely sponsored by Naturex of Avignon, France. Read more at www.MedicineHunter.com

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