The Creepy Ways Big Pharma Peddles its Drugs

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

By Martha Rosenberg, AlterNet
Posted on January 9, 2012

(Editor's Note: You can view the ads throughout the story and can click on the ad to enlarge it.)

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.

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.  

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?

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."

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.

"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?

How Big Pharma Hooked Americans on Drugs

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

 

Has America become a nation of psychotics? You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux.

Once upon a time, antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses - primarily schizophrenia and bipolar disorder - to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics. Parents are told that their unruly kids are in fact bipolar, and in need of anti-psychotics, while old people with dementia are dosed, in large numbers, with drugs once reserved largely for schizophrenics. Americans with symptoms ranging from chronic depression to anxiety to insomnia are now being prescribed anti-psychotics at rates that seem to indicate a national mass psychosis.

It is anything but a coincidence that the explosion in antipsychotic use coincides with the pharmaceutical industry's development of a new class of medications known as "atypical antipsychotics." Beginning with Zyprexa, Risperdal, and Seroquel in the 1990s, followed by Abilify in the early 2000s, these drugs were touted as being more effective than older antipsychotics like Haldol and Thorazine. More importantly, they lacked the most noxious side effects of the older drugs - in particular, the tremors and other motor control problems.

The atypical anti-psychotics were the bright new stars in the pharmaceutical industry's roster of psychotropic drugs - costly, patented medications that made people feel and behave better without any shaking or drooling. Sales grew steadily, until by 2009 Seroquel and Abilify numbered fifth and sixth in annual drug sales, and prescriptions written for the top three atypical antipsychotics totaled more than 20 million.  Suddenly, antipsychotics weren't just for psychotics any more.

Not just for psychotics anymoreBy now, just about everyone knows how the drug industry works to influence the minds of American doctors, plying them with gifts, junkets, ego-tripping awards, and research funding in exchange for endorsing or prescribing the latest and most lucrative drugs. "Psychiatrists are particularly targeted by Big Pharma because psychiatric diagnoses are very subjective," says Dr. Adriane Fugh-Berman, whose PharmedOut project tracks the industry's influence on American medicine, and who last month hosted a conference on the subject at Georgetown. A shrink can't give you a blood test or an MRI to figure out precisely what's wrong with you. So it's often a case of diagnosis by prescription. (If you feel better after you take an anti-depressant, it's assumed that you were depressed.) As the researchers in one study of the drug industry's influence put it, "the lack of biological tests for mental disorders renders psychiatry especially vulnerable to industry influence." For this reason, they argue, it's particularly important that the guidelines for diagnosing and treating mental illness be compiled "on the basis of an objective review of the scientific evidence" - and not on whether the doctors writing them got a big grant from Merck or own stock in AstraZeneca.

Marcia Angell, former editor of the New England Journal of Medicine and a leading critic of the Big Pharma, puts it more bluntly: "Psychiatrists are in the pocket of industry." Angell has pointed out that most of the Diagnostic and Statistical Manual of Mental Disorders (DSM), the bible of mental health clinicians, have ties to the drug industry. Likewise, a 2009 study showed that 18 out of 20 of the shrinks who wrote the American Psychiatric Association's most recent clinical guidelines for treating depression, bipolar disorders, and schizophrenia had financial ties to drug companies.

In a recent article in The New York Review of Books, Angell deconstructs what she calls an apparent "raging epidemic of mental illness" among Americans. The use of psychoactive drugs—including both antidepressants and antipsychotics—has exploded, and if the new drugs are so effective, Angell points out, we should "expect the prevalence of mental illness to be declining, not rising." Instead, "the tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007 - from one in 184 Americans to one in seventy-six. For children, the rise is even more startling - a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children." Under the tutelage of Big Pharma, we are "simply expanding the criteria for mental illness so that nearly everyone has one." Fugh-Berman agrees: In the age of aggressive drug marketing, she says, "Psychiatric diagnoses have expanded to include many perfectly normal people."

Cost benefit analysisWhat's especially troubling about the over-prescription of the new antipsychotics is its prevalence among the very young and the very old - vulnerable groups who often do not make their own choices when it comes to what medications they take. Investigations into antipsychotic use suggests that their purpose, in these cases, may be to subdue and tranquilize rather than to treat any genuine psychosis.

Carl Elliott reports in Mother Jones magazine: "Once bipolar disorder could be treated with atypicals, rates of diagnoses rose dramatically, especially in children. According to a recent Columbia University study, the number of children and adolescents treated for bipolar disorder rose 40-fold between 1994 and 2003." And according to another study, "one in five children who visited a psychiatrist came away with a prescription for an antipsychotic drug."

A remarkable series published in the Palm Beach Post in May true revealed that the state of  Florida's juvenile justice department has literally been pouring these drugs into juvenile facilities, "routinely" doling them out "for reasons that never were approved by federal regulators." The numbers are staggering: "In 2007, for example, the Department of Juvenile Justice bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children…That's enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day." Further, the paper discovered that "One in three of the psychiatrists who have contracted with the state Department of Juvenile Justice in the past five years has taken speaker fees or gifts from companies that make antipsychotic medications."

In addition to expanding the diagnoses of serious mental illness, drug companies have encouraged doctors to prescribe atypical anti-psychotics for a host of off-label uses. In one particularly notorious episode, the drugmaker Eli Lilly pushed Zyprexa on the caregivers of old people with Alzheimer's and other forms of dementia, as well as agitation, anxiety, and insomnia. In selling to nursing home doctors, sales reps reportedly used the slogan "five at five"—meaning that five milligrams of Zyprexa at 5 pm would sedate their more difficult charges. The practice persisted even after FDA had warned Lilly that the drug was not approved for such uses, and that it could lead to obesity and even diabetes in elderly patients.

In a video interview conducted in 2006, Sharham Ahari, who sold Zyprexa for two years at the beginning of the decade, described to me how the sales people would wangle the doctors into prescribing it. At the time, he recalled, his doctor clients were giving him a lot of grief over patients who were "flipping out" over the weight gain associated with the drug, along with the diabetes. "We were instructed to downplay side effects and focus on the efficacy of drug…to recommend the patient drink a glass a water before taking a pill before the  meal and then after the meal in hopes the stomach would expand" and provide an easy way out of this obstacle to increased sales. When docs complained, he recalled, "I told them, ‘Our drug is state of the art. What's more important? You want them to get better or do you want them to stay the same--a thin psychotic patient or a fat stable patient.'"

For the drug companies, Shahrman says, the decision to continue pushing the drug despite side effects is matter of cost benefit analysis: Whether you will make more money by continuing to market the drug for off-label use, and perhaps defending against lawsuits, than you would otherwise. In the case of Zyprexa, in January 2009, Lilly settled a lawsuit brought by with the US Justice Department, agreeing to pay $1.4 billion, including "a criminal fine of $515 million, the largest ever in a health care case, and the largest criminal fine for an individual corporation ever imposed in a United States criminal prosecution of any kind,''the Department of Justice said in announcing the settlement." But Lilly's sale of Zyprexa in that year alone were over $1.8 billion.

Making patients worse As it turns out, the atypical antipsychotics may not even be the best choice for people with genuine, undisputed psychosis.

A growing number of health professionals have come to think these drugs are not really as effective as older, less expensive medicines which they have replaced, that they themselves produce side effects that cause other sorts of diseases such as diabetes and plunge the patient deeper into the gloomy world of serious mental disorder. Along with stories of success comes reports of people turned into virtual zombies.

Elliott reports in Mother Jones: "After another large analysis in The Lancet found that most atypicals actually performed worse than older drugs, two senior British psychiatrists penned a damning editorial that ran in the same issue. Dr. Peter Tyrer, the editor of the British Journal of Psychiatry, and Dr. Tim Kendall of the Royal College of Psychiatrists wrote: "The spurious invention of the atypicals can now be regarded as invention only, cleverly manipulated by the drug industry for marketing purposes and only now being exposed."

Bottom line: Stop Big Pharma and the parasitic shrink community from wantonly pushing these pills across the population.

Selling Clinical Depression

Adding New Spin and Urgency to Depression Drug Sales
By MARTHA ROSENBERG

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Marketing of Madness: Are We All Insane?

The Marketing of Madness: Are We All Insane? (2009)

Psychotropic drugging - it's business. This is the story of the high-income partnership between psychiatry and drug companies that has created an $80 billion psychotropic drug profit center, and millions of patients addicted to these drugs or developing worse health problems due to the use of these drugs.

This movie will break your heart.

vidlink (if video doesn't show)

Drug Industry Fraud

The Whistle Has Been Blown, But Where's the Enforcement?
By RALPH NADER

The corporate defrauding of taxpayers (eg. Medicaid and Medicare) and prescription drugs with skyrocketing prices was the subject of a report by Public Citizen's Dr. Sidney Wolfe and his associates (see citizen.org).

Dr. Wolfe's team compiled a total of 165 federal and state settlements since 1991 totaling $19.8 billion in penalties. A key finding is that the drug industry's penalties under the Federal False Claims Act exceed even those assessed against the overcharging defense industry for fraud.

Before we become overly impressed with the cumulative amount of the penalties, specialists in corporate crime law enforcement believe that adding more federal cops on the corporate crime beat, backed by a determined law and order Justice Department with White House backing, would have greatly increased the number of cases and imposition of penalties on these drug industry giants.

Nonetheless, Dr. Wolfe's study shows that the pace of penalties has picked up over the past five years. This is due to "a combination of increased violations by companies and increased law enforcement on the part of federal and state governments," says the report.

Many of these cases were initiated by company whistleblowers, who under the False Claims Act can receive a share of the settlements. Since the corporate bosses of these drug firms are almost never prosecuted, what these executives fear the most are company employees who go public with the evidence of corporate misdeeds.

These violations do more than financial damage to consumers and government health insurance programs. One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Outside the purview of the Public Citizen study are the ravages of counterfeit drugs and poorly inspected ingredients in drugs, now mostly coming from China and India, due to the outsourcing by U.S. and European drug companies in their thirst for even greater profits.

Drug company sales are huge, growing from $40 billion in 1990 to $234 billion in 2008, and far exceeding inflation with their annual price gouging. To make matters worse, in 2003, the Congressional Republicans, with decisive support from some Democrats, passed the drug benefit bill which explicitly prohibited Uncle Sam, the payer, from bargaining for volume discounts with drug companies.

With over 400 full-time drug company lobbyists putting pressure on Congress, and tens of millions of dollars flowing into the legislators' campaign coffers, budgets for federal investigators, prosecutors and inspectors are kept to a minimum. Unfortunately, crime in the suites pays over and over again, despite occasional penalties.

A bright spot is the increasing enforcement action at the state level.

By last year, 32 states had enacted false claims acts, including fourteen states that qualified as strong laws by federal standards.

Still, the Wolfe report concludes that the "current system of enforcement is not working." He gives the examples of the $7.44 billion in financial penalties assessed over the past twenty years on GlaxoSmithKline and Pfizer, as compared to their combined total of $16.5 billion in global net profits in one year alone.

What would deter these illegal practices and risks to public safety? Dr. Wolfe says "the lack of criminal prosecution that would result in jailing of company executives." is key. Moreover, the report notes that "a felony conviction could result in their companies becoming ineligible for reimbursement from federal and state health programs, a critical source of pharmaceutical company revenues."

A flicker of hope that a little change is on the way came from the Food and Drug Administration's Deputy Chief Counsel for Litigation, Eric Blumberg. He indicated that the government is considering going after drug company executives for violations such as off-label promotions. He stated: ".unless the government shows more resolve to criminally charge individuals-at all levels in the corporate hierarchy--.we can not expect to make progress in deterring off-label promotion."

The problem is that the final operating decision is in the hands of the Justice Department-historically short-staffed and short-willed to entreaties for prosecution by the FDA and other regulatory agencies.

Furthermore, for over 30 years, the Justice Department has stone-walled requests that it start a corporate crime database as it has done with street crimes. Congress likes it this way, as it continues to cash corporate campaign checks.

Just last week, however, outgoing Judiciary Committee Chairman, Democrat John Conyers introduced a bill (H.R. 6545) to create such a corporate crime data base in the Justice Department. Well, as the saying goes, everything starts with a gesture!

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

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


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

1. Astroturf Patients?

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

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

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

2. Cheating the Government

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

3. Trials and Fibulations

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

4. More Trials and Fibulations

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

5. Overseas Adventurism

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

6. Clueless Institutional Review Boards

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

7. 'Previous Government Experience Desirable'

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

8. Double Dealing at the Pharmacy

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

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

9. FDA Foreplay

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

10. Pharma Service Announcements

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

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

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

11. National 'Interests' of Health

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

12. Big Pharma Sends Schools Doctors

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

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

13. Ghostwriting

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

A Congressional investigation doesn't qualify as a complaint?

14. Crooked Books and Slanted Messages

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

15. May I Take Your Order?

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

Big Pharma Shamelessly Shills Dangerous Bone Drugs You Don't Need

Drugs meant to strengthen bones may not work -- and many have a slew of harmful side-effects like a higher cancer risk, irregular heart rate, and stomach bleeding.
By Martha Rosenberg, AlterNet
Posted on November 15, 2010

If you feel like everyone is warning you about your bones and imminent osteoporosis, you are right. Boniva, an osteoporosis drug which actress Sally Field says helps women "stop losing and start reversing" bone, is one of the top 20 most advertised drugs. Bone drug Evista was personally promoted by former FDA deputy commissioner for medical and scientific affairs under George W. Bush, Scott Gottlieb. And "novel" bone drug Prolia, also called a Frankendrug, received a Best New Drug award this week at the 2010 Scrip Awards ceremony.

While most of the world is now aware of the risks of osteoporosis, the problem with the bone drugs is: they may not work and women may not need them.

According to National Public Radio, Merck hired a company to whip up fears of "osteopenia," the risk of getting osteoporosis, to get women to take Fosamax, the first bisphosphonate bone drug launched 15 year ago. The hired guns creating the faux "Bone Measurement Institute," planted bone scan machines in medical offices and pushing the Bone Mass Measurement Act which made scans Medicare-reimbursable. By the end of the 1990s the "disease" of osteopenia had increased seven fold according to the Associated Press.

Even the term osteopenia, created by World Health Organization, was co-opted. It was never meant to be "a disease in itself to be treated," says Dartmouth Medical School professor Anna Tosteson who attended the WHO meeting, and the osteopenia diagnostic criteria were decided arbitrarily because the scientists were tired and wanted to adjourn.

Like Merck's Vioxx, Merck's Fosamax was launched ahead of schedule and its side effects -- esophageal erosion, bleeding, inflammation and perforation (why patients have sit or stand for an hour after a dose) -- only emerged when the drug was reimbur$able. In fact, Merck was forced to send out Dear Doctor letters months after Fosamax' 1995 approval and the FDA threatened to revoke approval altogether until Merck's head of research at the time, Edward M. Scolnick, convinced it to simply add a warning.

At the same time the clinical picture of bisphosphonates (Roche and GSK's Boniva and Procter & Gamble's Actonel followed) worsened.

It turned out the same mechanism that stops bone loss, suppression of the body's bone remodeling action, can cause bones to become brittle and at risk of breaking because they are not renewed. Since 2006, so many medical journal articles have chronicled spontaneous breaks of thigh and other bones on bisphosphonates, the FDA ordered a fracture warning to appear on the drugs' labels in October. Over a dozen women report their bones breaking while taking bisphosphonates on the drug rating site askapatient.com.

And there are other morbid perks with bisphosphonates.

Dentists and oral surgeons discovered that after simple office procedures patients' jaw bones would not heal but become necrotic and die. Whether Merck hid the jaw bone data, as some dentists claim, or didn't know because only two, three-year Fosamax studies were conducted, many dentists refuse work on bisphosphonate patients and an FDA-mandated jaw bone death warning went on the label. (Some Merck doctors blamed the jaw bone death on "bad oral hygiene.")

Intractable pain and atrial fibrillation, chronically irregular heartbeat, were reported with the bisphosphonates in medical journals and the FDA reported 23 US esophageal cancers and 27 in Europe and Japan in 2008. (Why does FDA put esophageal, fracture and jaw bone warnings on a drug also linked to cancers rather than simply withdraw it?)

But even as the FDA warned about bisphosphonate fractures last month, full page color ads in the New York Times offered women a new bone option: Evista, a Selective Estrogen Receptor Modulator (SERM) similar to the breast cancer drug Tamoxifen.

"You can take Evista at any time of day, with or without food," say the Eli Lilly ads without having to add "unlike SOME drugs we know."

Evista is approved for treatment and prevention of osteoporosis in postmenopausal women and reducing invasive breast cancer risk in other patient groups but it has its own negatives. Researchers at the University of Illinois and University of Southern California link it to ovarian cancer and its label warns about "increased risk of venous thromboembolism and death from stroke." Evista was originally promoted as reducing heart attacks and stroke. Oops.

Of 250 users on askapatient, 130 say they developed debilitating joint pain or muscle cramps on Evista, similar to bisphosphonates (though Evista rates higher than Boniva which is the lowest rated drug of 4,200.)

Many say they developed insomnia, memory loss, hair loss and eye problems -- SERMS are linked to cataracts -- but most alarming is: patients report losing bone density on a drug designed to preserve bone density.

And there's another macabre option for women's bone health. Amgen's Prolia, a monoclonal antibody derived from genetically engineered mammalian Chinese hamster ovary cells, was approved in June to prevent fractures in people with osteoporosis, two months earlier than expected.

Biologics are more lucrative for pharma than pills and lack generic competition -- Amgen's twice yearly Prolia injection costs $1650 per year -- but they suppress the immune system's tumor necrosis factor and cause malignancies, infections, tuberculosis and worse. During Prolia trials, 10 volunteers were hospitalized with the skin infection cellulitis and one died. Two monkeys died of protozoal infections on the drug and others developed tooth and jaw abscesses. (Jaw bone death is listed under Prolia's warnings and precautions.)

Immune-suppressing biologic drugs, broadly marketed for "RA," rheumatoid arthritis, which some say is pharma's next push, and to healthy college kids, are also associated with -- you guessed it!-- bone loss!

Of course no one is suggesting that fractures, especially in the elderly, are not a real problem. But increasingly doctors are looking at solutions other than bone drugs.

"The strongest single risk factor for fracture is falling and not osteoporosis," says a 2008 article in the British Medical Journal called Shifting The Focus in Fracture Prevention From Osteoporosis to Falls. "Despite this fact, few general practitioners will have assessed the risk of falling among their elderly patients or even know how to do it."

"Avoiding drugs that increase the likelihood of falling may be just as important as taking drugs that can make bones stronger," add People's Pharmacy authors Joe and Teresa Graedon, especially sedatives, sleeping pills and anxiety pills.

In fact many everyday pills like diuretics and anticoagulants can cause osteoporosis says an October article in The American Journal of Medicine.

A January British Medical Journal study of 68,500 younger women found calcium and Vitamin D reduced fractures by 50 percent while bisphosphonates exerted no action (unless you count that they "negate the effect" of the two supplements, according to the authors),

In fact, Vitamin D and calcium, given with placebo, actually outperformed Prolia in clinical trials.

Researchers are also looking at Vitamin K for osteoporosis protection and the elder plant, often taken to boost the immune system.

And then there's diet.

"There is growing evidence that consumption of a Western diet is a risk factor for osteoporosis through excess acid supply," says an article in the February Proceedings of the Nutrition Society. "Healthy adults consuming such a diet are at risk of chronic low-grade metabolic acidosis, which worsens with age as a result of declining kidney function."

Dean Ornish, Clinical Professor of Medicine at the University of California, San Francisco agrees. "For every gram of excess protein consumed (sulfur amino acid in particular) calcium loss is increased by 1 mg," he writes in a 2005 Journal of the American Dietetic Association. So do recent articles in the Journal of Bone and Mineral Research, Osteoporosis International, nutritionist Nathan Pritikin and probably Michael Pollan.

Long before bone drugs, the government supported "milk mustache" campaign warned teenage girls if they didn't drink milk they could get osteoporosis later in life, in 1993. Not that teens and tweens living with their parents worried about getting old or bone fractures.

A USDA expert panel threw out the bone benefit claims in 2001 but not before the Secretary of Health and Human Services herself, Donna Shalala posed for milk ads in 1998 and kicked off a "milk mobile" tour of 100 cities which offered free bone-density screenings.

The Center for Science in the Public Interest and fellows at the Brookings Institution objected to the government's top health official appearing in corporate advertising, but Shalala insisted that her promotion of the milk industry was to help the public prevent osteoporosis later in life. Today she