Bloomberg News – Feb 2, 2012

By Jef Feeley 

Johnson & Johnson hid studies showing its Risperdal anti-psychotic drug caused diabetes to protect billions of dollars in sales, a lawyer said in the first personal-injury claim over the medication to go to trial.

Researchers at J&J’s Janssen unit knew as early as 1999 that a study found Risperdal caused diabetes at a higher rate than a competing drug and failed to hand over the results to regulators probing links between the disease and anti-psychotic medicines, Fletch Trammell, a lawyer for a former Risperdal user, told a New Jersey jury today in opening statements.

“The evidence will show Janssen buried studies for a competitive advantage,” Trammell told jurors in state court in New Brunswick, New Jersey. J&J, the world’s second-largest health-products maker, is based in the city.

The trial of Gary Skala’s claims that his 14 years’ worth of Risperdal use caused his diabetes began two weeks after J&J agreed to pay $158 million to settle Texas officials’ claims that it fraudulently marketed the drug.

While J&J has faced four states’ claims that it defrauded Medicaid programs by misleading doctors and regulators about Risperdal’s diabetes risks, Skala’s case is the first brought by an individual patient to be presented to a jury.

The drugmaker contends that the study evaluating Risperdal’s diabetes risk against that posed by Eli Lilly & Co.’s Zyprexa anti-psychotic medication was flawed and that’s why it wasn’t made public, one of the company’s lawyers told jurors today.

‘Nothing Was Buried’

“Nothing was buried, nothing was hidden and no one was tricked,” Jeffrey Peck, a lawyer for J&J, said in his opening statement.

Risperdal, once J&J’s best-selling drug, generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007. Afterward, J&J lost patent protection and sales declined.

Lawyers for Risperdal patients contend J&J officials aggressively pushed the drug for unapproved uses and lied about its links to diabetes to pump up sales.

A judge in South Carolina who reviewed claims about the company’s Risperdal marketing campaigns concluded last year that J&J officials “allowed the profit-at-all-costs mentality to cloud” their judgment about the handling of the drug.

Attempted Suicide

Skala’s lawyers said the 56-year-old Nebraska resident started taking Risperdal in 1996 after attempting suicide by taking an overdose of anti-anxiety medicine. The former college maintenance man steadily gained weight while on the drug and was diagnosed with diabetes in 2002, Trammell said. Skala wasn’t obese when he started Risperdal and didn’t have a family history of the disease, the lawyer said.

“He went to them for help and they gave him diabetes,” Trammell said of J&J.

Peck countered that Skala’s weight gain and diabetes was caused by his excessive alcohol use and sedentary lifestyle rather than by Risperdal. After Skala stopped drinking in 2010, “he lost 25 pounds,” the J&J lawyer said.

The presentation of evidence in the case, which is being overseen by Judge Jessica Mayer, is expected to last two weeks.

J&J faces more litigation over Risperdal next month when the state of Arkansas’s claims that the drugmaker misled doctors and Medicaid supervisors about the medicine’s health risks are set for trial.

Litigation Record

In 2010, the company lost a Risperdal case in Louisiana, where on top of a $257.7 million jury award the judge ordered the company to pay $73.3 million in attorneys’ fees and costs. A year later, a South Carolina judge ordered J&J to pay $327 million in damages after a jury found its Risperdal marketing practices violated fraud and consumer protection laws.

J&J also has agreed to pay more than $1 billion to the U.S. and a number of states to end a civil probe into its Risperdal marketing practices, people familiar with the matter told Bloomberg News on Jan. 6.

The U.S. government has been investigating Risperdal sales practices since 2004, including allegations the company engaged in so-called off-label marketing of the medication, J&J has said in U.S. Securities and Exchange Commission filings. The company said it has been negotiating with the U.S. to resolve the investigation.

http://www.bloomberg.com/news/2012-02-02/j-j-hid-risperdal-studies-to-boost-drug-sales-lawyer-says-at-n-j-trial.html

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“We’re like Cinderella’s older stepsisters,” a psychiatrist told me the other day. “We’re trying to stick our fat feet into the delicate slipper so the prince can take us to the ball. But we ain’t going to the ball right now.” Which is why we might feel a little sorry for the beleaguered A.P.A

The New York Time – Jan 30, 2011
By GARY GREENBERG
YOU’VE got to feel sorry for the American Psychiatric Association, at least for a moment. Its members proposed a change to the definition of autism in the fifth edition of their Diagnostic and Statistical Manual of Mental Disorders, one that would eliminate the separate category of Asperger syndrome in 2013. And the next thing they knew, a prominent psychiatrist was quoted in a front-page article in this paper saying the result would be fewer diagnoses, which would mean fewer troubled children eligible for services like special education and disability payments.

Then, just a few days later, another front-pager featured a pair of equally prominent experts explaining their smackdown of the A.P.A.’s proposal to eliminate the “bereavement exclusion” — the two months granted the grieving before their mourning can be classified as “major” depression. This time, the problem was that the move would raise the numbers of people with the diagnosis, increasing health care costs and the use of already pervasive mind-altering drugs, as well as pathologizing a normal life experience.

Fewer patients, more patients: the A.P.A. just can’t win. Someone is always mad at it for its diagnostic manual.

It’s not the current A.P.A.’s fault. The fault lies with its predecessors. The D.S.M. is the offspring of odd bedfellows: the medical industry, with its focus on germs and other biochemical causes of disease, and psychoanalysis, the now-largely-discredited discipline that attributes our psychological suffering to our individual and collective history.

This tension has been high since at least 1917. That’s when Thomas Salmon, a future head of the A.P.A. — which was founded in 1844 — noted that psychiatry’s “classification of mental diseases is chaotic.” He worried that “this condition of affairs discredits the science of psychiatry and reflects unfavorably upon our association” and urged his membership to forge a diagnostic system “that would meet the scientific demands of the present day.”

The American Psychiatric Association has been trying to do just that ever since, mostly by leaving behind ideas about the meaning of our suffering in favor of observation and treatment of its symptoms. In 1980, it hit on the strategy of adopting a medical rhetoric, organizing those symptoms into neat disease categories and checklists of precisely described criteria and publishing them in the hefty — and, according to its chief author, “very scientific-looking” — D.S.M.-III.

That book, with its more than 200 objectively described diagnoses, would have made Dr. Salmon proud. By meeting the scientific demands of the day, it was credited by many with having rescued psychiatry from the brink of extinction, and its subsequent revisions have been the cornerstone of the profession’s survival as a medical specialty.

But as all those Diagnostic and Statistical Manuals have stated clearly in their introductions, while the book seems to name the mental illnesses found in nature, it actually makes “no assumption that each category of mental disorder is a completely discrete entity with absolute boundaries dividing it from other mental disorders or no mental disorder.” And as any psychiatrist involved in the making of the D.S.M. will freely tell you, the disorders listed in the book are not “real diseases,” at least not like measles or hepatitis. Instead, they are useful constructs that capture the ways that people commonly suffer. The manual, they go on, was primarily written to give physicians, schooled in the language of disease, a way to recognize similarities and differences among their patients and to talk to one another about them. And it has been fairly successful at that.

Still, “people take it literally,” one psychiatrist who worked on the manual told me. “That is its strength in a political sense.” And even if the A.P.A. benefits mightily from that misperception, the troubles on the front page are not the organization’s fault. They are what happens when we expect the D.S.M. to be what it is not. “The D.S.M. has been taken too seriously,” another expert told me. “It’s the victim of its success.”

Psychiatrists would like the book to deserve a more serious take, and thus to be less subject to these embarrassing diagnostic squabbles. But this is going to require them to have what the rest of medicine already possesses: the biochemical markers that allow doctors to sort the staph from the strep, the malignant from the benign. And they don’t have these yet. They aren’t even close. The human brain, after all, may be the most complex object in the universe. And the few markers, the genes and the neural networks, that have been implicated in mental disorders do not map well onto the D.S.M.’s categories.

“We’re like Cinderella’s older stepsisters,” a psychiatrist told me the other day. “We’re trying to stick our fat feet into the delicate slipper so the prince can take us to the ball. But we ain’t going to the ball right now.” Which is why we might feel a little sorry for the beleaguered A.P.A.

On the other hand, given that the current edition of the D.S.M. has earned the association — which holds and tightly guards its naming rights to our pain — more than $100 million, we might want to temper our sympathy. It may not be dancing at the ball, but once every mental health worker, psychology student and forensic lawyer in the country buys the new book, it will be laughing all the way to the bank.

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The StarPhoenix January 26, 2012

by Les MacPherson

 It has come to my attention that I am mentally ill.

I always knew I was neurotic – who isn’t? – but it still comes as something of a surprise to learn that I am suffering from an actual mental illness. Others, perhaps, will not be surprised in the least.

The particular mental illness that afflicts me was added only recently to the so-called Bible of psychiatry, otherwise known as the Diagnostic and Statistical Manual of Mental Disorders. This is the big reference book that officially catalogues all the mental illnesses recognized by modern psychiatry. The latest edition is nearly 1,000 pages. You would have to be almost pathologically normal to find nothing in there that applies to you.

Qualifying as entirely sane does not get any easier when new disorders are regularly added to the already voluminous manual. The goalposts of sanity now have been moved so close together that I can no longer squeeze through.

What afflicts me is one of the latest additions proposed for the diagnostic manual, something called avoidant/ restrictive food intake disorder, or ARFID. Until recently, people suffering from this disorder were dismissed as picky eaters. Now, we suddenly are sick and need help.

ARFID is defined as an “eating or feeding disturbance” that includes avoiding foods of a particular taste, colour or texture. That’s exactly what I do. I avoid foods if the taste is bad, if the texture is lumpy or slimy and if the colour is grey, green or mottled beige. If this makes me mentally ill, I plead not hungry by reason of insanity.

Consider oatmeal, for example, a slimy, lumpy, grey food I have always found unspeakably horrible. I always thought it was the people who liked oatmeal who were mentally ill. And yet it clearly is not them but me whose symptoms are to be described in psychiatry’s foremost diagnostic textbook. Well, I don’t care what the doctors say, I still hate oatmeal.

I hate liver, too. If there was a religion that forbade eating liver, I would sign on as a missionary: Eat not of the liver, for it is an unclean thing, and also slimy, with a putrid taste and disgusting appearance. Whosoever filleth his mouth with liver, whether cooked with bacon or not, shall be cast into the fiery pit, along with some fried onions.

This is somewhat by the way, but notice how easily mental illness is repurposed as theology. It goes the other way, too, when the mentally ill are afflicted with religious delusions. I have never heard of a mentally ill person yet who thought he was a newspaper columnist, incidentally, except, of course, for those who really are newspaper columnists.

If it was just liver and oatmeal that provoked my involuntary gag reflex, I probably would not need professional help. There are many other foods, however, that I would rather wrap in a napkin and secretly slip into my pocket than eat. Among them are broccoli, spinach and all organ meats except the baloney. Heart, lungs or tongue will be scraped off my plate untouched, but I do like a thin slice of baloney, in a sandwich with lettuce and a little mustard.

I also cannot eat anything smothered in cream sauce. Any food that could possibly be improved by immersion in cream sauce I would dispose of as hazardous waste.

Asparagus likewise disgusts me. Fish, too, I mostly find off-putting. It doesn’t help when I am told that this particular fish dish has no fishy taste. Why would anyone want to eat something that is not supposed to taste like what it is? I wouldn’t eat beef, either, if the best that could be said of it was that it had no beefy taste. And I’m supposed to be the crazy one?

Now that picky eating is to be regarded as a mental illness, we can perhaps look forward to a cure. The big pharmaceutical companies probably are working even now on new drugs to treat the disorder. Imagine a pill that could make me like liver.

I’d spit it out when no one was looking.

http://www.thestarphoenix.com/health/Latest+list+mental+disorders+leaves+taste+mouth/6052784/story.html

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ProPublica
By Charles Ornstein and Tracy Weber
January 24, 2012

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“Janssen ran amok,” Allen Jones, the Pennsylvania-based whistleblower on J&J’s marketing practices who was a plaintiff along with state of Texas, told reporters in the Austin courthouse.

“They trashed the Johnson & Johnson credo and they misused Texas and, I believe, well-meaning officials, to further their marketing aims,” Jones said. “They subverted science and they induced others to betray the people they were supposed to be taking care of. To me that is reprehensible.”

January 20, 2012/Reuters

J&J to pay $158 million to settle Texas Risperdal case

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The New York Times – January 16, 2012

by Robert Pear

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul. “The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

WASHINGTON — To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.

Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Federal officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.

The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.

The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.

Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.

Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.

The new requirements, or something very similar, will take effect soon; in fact, they are overdue. Under the new health care law, the administration was supposed to establish payment-reporting procedures by Oct. 1, 2011. The public will have until Feb. 17 to comment on the proposals, which are broadly consistent with the expectations of industry and consumer groups. After considering the comments, Medicare officials will issue final rules with the force of law.

Consumer advocates have long demanded details of the financial ties between doctors and drug and device companies.

Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”

In an introduction to the proposed rules, the Obama administration says that patients can benefit when doctors and the industry work together to develop life-saving drugs and devices. But, it said, these relationships can also “lead to conflicts of interests that may affect clinical decision-making” and “threaten the underlying integrity of the health care system.”

The administration does not try to define the difference between proper and improper payments. It says simply that public reporting of the financial ties between doctors and drug and device companies “will permit patients to make better-informed decisions when choosing health care professionals and making treatment decisions.”

The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul.

“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.

Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.

“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said.

Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.

Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing.

As an example of inappropriate payments, the inspector general of the Department of Health and Human Services cited a case in which manufacturers of medical devices had provided financial incentives — in the form of consulting agreements, lavish trips and other perks — to induce doctors to use particular hip and knee replacement products. Under a civil settlement with the government, the companies agreed to new compliance procedures.

The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks.

The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery.

http://www.nytimes.com/2012/01/17/health/policy/us-to-tell-drug-makers-to-disclose-payments-to-doctors.html?_r=2&pagewanted=all

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Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said.

Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin. Texas is suing J&J, saying the company fraudulently promoted Risperdal and overbilled Medicaid by at least $579 million.

State lawyers say Janssen’s payments to Shon were part of a scheme to influence development of the guidelines, known as the Texas Medication Algorithm Project, or TMAP, and tout them as a model for other states trying to advise doctors on prescribing drugs. Shon was asked how often he went around the U.S. to talk to other states about the TMAP.

“I would say once or twice a month for a period of several years,” Shon said in a video deposition shown to jurors on the trial’s second day of testimony. “I knew that Janssen paid for a substantial number of those trips.”

Texas also claims that New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, defrauded the state Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders. The state joined a lawsuit filed by a whistle-blower, Allen Jones, a former investigator for the Pennsylvania Office of Inspector General.

Medical Director

Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006.

Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called “Mental Health Issues Today” and was a continuing medical education speaker in programs sponsored by the company.

Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said.

In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years.

Jones’s attorney Thomas Melsheimer asked Shon about Texas regulations that bar a public official from “soliciting, accepting or agreeing to accept any honorarium for doing services” that he wouldn’t be asked to provide “but for that person’s official position or duties.”

Outside of Texas

Shon said his TMAP talks outside of Texas didn’t conflict with his official duties, and he gave them during compensatory time. When asked about a 2000 trip to Scottsdale, Arizona, when his timesheet showed he was at work, he said: “It appears that things were not recorded correctly.”

On cross-examination, Shon said Janssen had no influence over the development of the TMAP guidelines.

He said a state attorney, Cathy Campbell, told him that his appearances in other states were proper. He said he usually gave his honorariums to the state, based on Campbell’s advice.

In those cases when he kept the payments, Shon said, the lawyer advised him that his actions were proper.

‘Something Wrong’

“Did anybody ever tell you that you were doing something wrong in conjunction with your work with TMAP?” a J&J attorney asked Shon.

“No,” he answered.

Shon said he left his state job when he was told “it was time to move on,” he testified.

“Did anybody ever tell you that you had done something wrong, and that’s why it was time to move on?” he was asked.

“No,” he said.

In his opening statement yesterday, Melsheimer said J&J made $34 billion in Risperdal sales after its launch in 1994.

J&J denies wrongdoing and never acted illegally, attorney Stephen McConnico told jurors yesterday in his opening statement.

The case is State of Texas ex rel. Jones v. Janssen LP, D- 1GV-04-001288, District Court, Travis County, Texas (Austin).

Read article here:  http://www.bloomberg.com/news/2012-01-11/johnson-johnson-paid-texas-official-to-speak-around-the-u-s-jury-told.html

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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.

Click to enlarge image

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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The Dallas Morning News
By Janet Elliott and Mark Curriden
January 8, 2012

AUSTIN — A routine inquiry a decade ago by an investigator for the Pennsylvania inspector general exposed a pattern in which pharmaceutical companies showered trips, meals and other perks on state officials in positions to influence which drugs would be used to treat patients under Medicaid.

The efforts appeared to have been particularly successful in Texas, which has one of the largest Medicaid populations.

In 2004, Allen Jones, a whistle-blower who worked with the Pennsylvania inspector general, filed suit alleging that pharmaceutical giant Johnson & Johnson improperly marketed its antipsychotic drug Risperdal for unapproved uses while funneling money to members of a state panel charged with recommending drug treatments for those in state health programs.

Two years later, Texas Attorney General Greg Abbott joined the lawsuit, seeking hundreds of millions of dollars in damages.

The case has been described by lawyers as the biggest lawsuit in Texas since the tobacco litigation in the 1990s. It goes to trial Monday in state court in Austin.

The high-stakes lawsuit alleging Medicaid fraud seeks $579 million in damages from Janssen, a division of New Jersey-based Johnson & Johnson, and penalties that could exceed an additional $500 million. The federal government will get half of any money recovered in the case, and Jones could receive between 10 and 25 percent.

The Texas case is separate from a reported $1 billion settlement reached just last week between Johnson & Johnson and others states over the marketing of Risperdal.

Risperdal was among antipsychotic drugs introduced in the 1990s. Initially approved for adults with schizophrenia, it soon became widely used in Texas mental hospitals and prisons for “off-label” uses, including for youths in the state’s foster care system.

“Not only was Risperdal not more effective, its risks were worse than its competitors and it was 45 times more expensive,” said Tom Melsheimer, a partner at Fish & Richardson in Dallas who represents the whistle-blower. “The company’s claim that its product was superior and its off-label promotional efforts were not supported by science.”

What did support Janssen’s promotional efforts were influential decision makers — including state employees, University of Texas faculty and mental health advocates — who received consulting fees, extravagant meals and travel accommodations, research funding and honoraria, according to the lawsuit.

Janssen denies that it misrepresented Risperdal and rejects allegations that its marketing efforts inflated the state’s spending on the drug. In court filings, the drug company points to the state’s continued use of Risperdal since joining the whistle-blower’s case in 2006.

Follow the money

In the 2010 fiscal year, Texas spent $15.016 million on Risperdal and $13.275 million on its generic equivalent for patients enrolled in Medicaid and the Children’s Health Insurance Program. The drugs cost an average of $229 per prescription, a 2006 Texas comptroller’s report said.

The program known as the Texas Medication Algorithm Project, or TMAP, started in the mid-1990s when state mental health officials contracted with the University of Texas and some of its professors to evaluate medications for treating mental illnesses and disorders.

Jones and the state allege that a process designed to be based on independent experts was co-opted by Janssen using false and misleading information, including ghostwritten articles and industry-funded studies, while playing down side effects, including weight gain and diabetes.

“Defendants thus ‘seeded the literature’ and increased the ‘noise level’ in the Texas health care community, including the Texas Medicaid community, with their false and misleading tale of Risperdal’s superiority to other antipsychotics and suitability for off-label use on vulnerable populations,” the state says in its most recent filing in the case.

Janssen is prepared to vigorously defend itself against these claims, spokeswoman Teresa Mueller said in emailed statement.

“We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication,” Mueller said. “If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action.”

Before the marketing blitz, the market was limited for Risperdal, Melsheimer said.

“Janssen determined in 1993 that the market for this drug was the 1 percent of adults with diagnosed schizophrenia, which was a $1 billion market,” he said. “So, the company created a new market for the drug. They created the perception that the drug was a breakthrough for expanded off-label treatments. As a result, the revenue generated by the sale of Risperdal jumped to $34 billion between 1997 and 2010.”

Fees, meals and trips

The most sensational allegations involve Janssen’s use of inducements, including consulting fees, meals, travel accommodations, research funding and honorariums. A key target was Dr. Steven Shon, medical director of the Texas Department of Mental Health and Mental Retardation. Records filed in the case show that Shon received $30,000 in fees and honoraria as a frequent speaker at Johnson & Johnson-sponsored events around the U.S.

David Rothman, a Columbia University professor who studies relations between medicine and the pharmaceutical industry, said in a report that Shon’s conduct was an “acute conflict of interest.” Shon, who resigned in October 2006, said in a deposition that he did not believe he influenced the placement of drugs on TMAP because he was an administrator and not a decision maker in the TMAP process.

Another potential witness in the case is M. Lynn Crismon, dean of the University of Texas College of Pharmacy. Crismon was a professor and member of the TMAP advisory panel in the mid-1990s when he “cultivated a financial relationship with J&J, accepting substantial fees and honoraria and soliciting research grants from the company,” according to Rothman’s report. “As a result, Dr. Crismon subverted the scientific integrity of his research and educational presentations, and biased his decision-making capacity as a member of TMAP.”

Crismon did not respond to a request for comment.

Jury selection is expected to take one day, with opening statements starting Tuesday. The trial could last four weeks.

Read article here:  http://www.dallasnews.com/business/health-care/20120108-texas-ag-suit-over-the-drug-risperdal-goes-to-trial-monday.ece

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