Posts Tagged ‘Eli Lilly’

4 Creepy Ways Big Pharma Peddles its Drugs

Tuesday, January 10th, 2012

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

Alternet
By Martha Rosenberg
January 9, 2012

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

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

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

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

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

1. You’re Sicker Than You Think

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

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

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

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

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

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

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

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

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

2. Your Kid Is Sick 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Study: Antidepressants actually cause many people to have worse depression

Tuesday, December 20th, 2011

NaturalNews – December 20, 2011

Most who received placebo saw a gradual improvement in depression symptoms, while nearly 20% of those taking antidepressants became worse

A recent industry-funded study on antidepressant drugs has revealed that the medications can cause roughly 20 percent of patients to get worse depression symptoms than if they simply took nothing. Published in the journal Archives of General Psychiatry, the study, which was largely controlled by drug giant Eli Lilly, is an eye-opener for those who still put their faith in antidepressants like Cymbalta (duloxetine), which carry with them life-altering side effects.

Ralitza Gueorguieva, lead author of the study from the Yale University School of Health, and her colleagues conducted trials on 2,500 people, all of whom were given either Cymbalta, various other antidepressant drugs, or a drug-free placebo for two months. At the conclusion of the study, most of those who received the placebo saw a gradual improvement in their depression symptoms, while nearly 20 percent of those taking antidepressants saw a worsening of their symptoms.

Those taking antidepressants rather than a placebo were grouped into one of two groups — “responders” or “non-responders.” Responders allegedly saw some improvement from the drugs, while non-responders saw no improvement at all. Eighty-four percent of all patients in the drug groups reportedly saw some improvement, while 16 percent saw no improvement at all — and this 16 percent actually saw a worsening of symptoms, as well as various other harmful side effects.

According to Reuters Health one of the study’s three authors is an employee of Eli Lilly, the company that makes Cymbalta, while another is on the company’s scientific advisory board.

What this all means is that patients who choose to use antidepressants, despite the numerous studies showing that they really do not work and can cause tremendous harm (http://www.naturalnews.com/antidepr…), as well as their doctors, need to pay close attention to what effect the drugs are having. If no improvement is seen, it is perhaps best to stop using the drugs completely and turn to alternatives.

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Time Magazine: Why Are So Many Foster Care Children Taking Antipsychotics?

Wednesday, November 30th, 2011

11/29/2011 by Maia Szalavitz

More than 8% of children in foster care have received antipsychotic medication, and just over one quarter of those in foster care who also receive disability benefits take these drugs, according to a recent studyin the journal Pediatrics.

The question is why? Children in foster care have typically been neglected or abused — indeed, simply removing a young child from his or her parents, even abusive ones, is in itself traumatic — so, not surprisingly, kids in foster care are more likely to suffer from psychiatric and behavioral problems than those who have stable families. Previous data suggest that foster-care children are about twice as likely as those outside the system to receive psychiatric medications.

Whether these problems are leading to higher rates of antipsychotic use, however, is not clear. “I think we have clinicians facing some very challenging situations,” says Susan dosReis, associate professor at the University of Maryland School of Pharmacy and lead author of the study. “But we don’t have information as to why the prescribers decided on these medications for [these particular] youths.”

The numbers suggest that the influence of pharmaceutical company marketing cannot be overlooked. Ninety-nine percent of youth receiving antipsychotic medications in the study were given atypical antipsychotics — the newer generation of these drugs, which are expensive and mostly unavailable in generic form and have been heavily advertised.

All of the major manufacturers of these drugs have been fined by the Food and Drug Administration for illegal marketing practices — in part, for marketing the drugs for unapproved use in children — with some convicted of criminal charges.

Eli Lilly, which manufactures the atypical antipsychotic Zyprexa, paid out $1.42 billion in 2009 — $615 million of that to settle criminal charges. The charges against Lilly involved selling Zyprexa to doctors for use in children, despite the fact that it was not approved for this age group.

Bristol Myers Squibb paid $515 million in 2007 to settle charges that it also illegally pushed its antipsychotic Abilify to child psychiatrists. Pfizer paid out $301 million in a similar case related to its drug Geodon. AstraZeneca paid out $520 million to settle charges over the drug Seroquel. In all of these cases, the drugs were sold for unapproved use in youth.

Read the rest of the article here

Watch one foster kid’s story:

 

 

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With growing public awareness of antidepressant risks: Pro-pill website Web MD does damage control

Monday, October 24th, 2011

OpEdNews – October 24, 2011

by Martha Rosenberg

WebMD, the gigantic, pro-pill web site whose original partner was Eli Lilly, is doing damage control for SSRI antidepressants.

There was a day when it seemed like everyone was on antidepressant “happy pills” like Prozac, Paxil and Zoloft. But then the pendulum began to swing. Patients objected to the weight gain and feelings of not being “themselves,” sexual side effects and the withdrawal symptoms. There were even reports and warnings about suicide and other “neuropsychiatric” effects.

Now, WebMD, the gigantic, pro-pill web site whose original partner was Eli Lilly, is doing damage control for SSRI antidepressants. New articles, sounding like they’re from crib makers or cantaloupe growers, urge patients not to panic or quit taking their pills just because of things they read.

Don’t believe all the hooey about antidepressants turning “you into a zombie,” ruining your sex life or costing too much, says an article called Fears and Facts About Antidepressants on WedMD. And don’t be impatient!   “ If the first antidepressant medication doesn’t help, the second or third often will . Most people eventually find one that works for them.” Ka-ching.   Don’t listen to all that suicide talk either!   “Switching to a different antidepressant may help,” say the damage control articles.

Is your fear of becoming a drug lifer keeping you from antidepressants, asks another WebMD article called What’s Stopping You from Seeing a Doctor About Depression? “If you do need a medication, it most likely won’t be for life,” says the article. Just until the patent runs out?

Do you think you can ignore your depression and it will go away?   “Waiting for depression to simply pass can be harmful,” because “depression that goes untreated may become more severe,” say the WebMD articles–rewriting medical practice itself since depression has never been a progressive disease but is actually self limiting.

The important thing, say the articles, is to never stop your meds. “Stopping medication abruptly may.. cause depression to return,” and can cause side effects, say the articles. Worse–”prescription abandonment”–people who discover what a drug costs and leave it at the pharmacy or quit drugs because of their effects– costs Pharma lots of money! Pharma even has programs now that send Big Brother nurses to people’s homes, through their pharmacies, to make sure people are taking their meds.

 One antidepressant with a big PR problem is Eli Lilly’s Cymbalta. It’s linked to the deaths of   Traci Johnson, a healthy 19-year-old who hung herself on the Lilly campus during clinical trials in 2004, and Carol Anne Gotbaum, daughter-in-law of former New York City Public Advocate Betsy Gotbaum who died in police custody at Phoenix’s Sky Harbor airport in 2007.

Cymbalta is noted in the scientific literature for producing suicidal side effects in people with no mental health history. A 37-year-old man described in the Journal of Clinical Psychopharmacology with a stable marriage and employment and no history of mental problems tried to kill himself with carbon monoxide two months after taking Cymbalta for back pain. A 63-year-old man, also with no mental health history, became suicidal on the drug after two weeks.

“There is an emergence of suicidality in apparently nonsuicidal patients after starting or increasing Duloxetine [Cymbalta] reads an article in Clinical Practice and Epidemiology in Mental Health.”

But now, Cymbalta is being promoted as a pain drug of choice like it’s not a repurposed antidepressant with antidepressant side effects. Last year it was approved for chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain, and it was already approved for fibromyalgia and diabetic nerve pain.

A Cymbalta ad in October’s New England Journal of Medicine , says “Today a non-NSAID [non- aspirin or ibuprofen] non-narcotic, once daily analgesic FDA approved for 3 indications across 4 different chronic pain conditions can be found in 1 med.” Sounds as safe Vioxx.

http://www.opednews.com/articles/Should-You-Take-A-Psychiat-by-Martha-Rosenberg-111023-164.html

Martha Rosenberg’s first book , Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, will be published by Prometheus Books in 2012.

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Doctors rarely face consequences for drug kickbacks

Tuesday, September 20th, 2011

The News Tribune – September 20, 2011
by Tracy Weber and Charles Ornstein; ProPublica

Despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians

Two years ago, drugmaker Eli Lilly pleaded guilty to illegally marketing its blockbuster antipsychotic Zyprexa for elderly patients. Lilly paid $1.4 billion in criminal penalties and settlements in four civil lawsuits.

But a doctor named as a co-defendant in one suit – for allegedly taking kickbacks to prescribe the drug extensively at nursing homes – never was pursued.

Last year, Alpharma paid $42.5 million to settle federal allegations that it paid kickbacks to doctors to prescribe its painkiller Kadian.

“Health-care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” Rod Rosenstein, U.S. attorney for the District of Maryland, said in a statement announcing the settlement.

But the doctors, accused of trading prescriptions for paid speaking gigs, faced no consequences.

At least 15 drug and medical-device companies have paid $6.5 billion since 2008 to settle accusations of marketing fraud or kickbacks. However, none of the more than 75 doctors named as participants was sanctioned, despite allegations of fraud or of conduct that put patients at risk, a review by ProPublica found.

Reporters reviewed hundreds of pages of court records and interviewed current and former federal prosecutors, state medical board officials, attorneys for whistle-blowers and, when possible, the doctors. For each doctor identified in a suit, ProPublica checked for state medical board discipline, penalties from the Medicare program and federal criminal charges.

In many of the cases, it appears that not even a cursory investigation was done to see whether the physicians had behaved inappropriately.

“Doctors have kind of gone under the radar,” said Tavy Deming, a Philadelphia lawyer who represents drug company whistle-blowers.

Amid concerns about the influence of drug company money on medicine, whistle-blower lawsuits have emerged as a headline-grabbing tool for holding manufacturers accountable.

Yet, despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians. Doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the suits. And even when settling, many companies, including Alpharma, continue to deny the allegations.

After cases are resolved, the internal company documents used as evidence remain confidential, preventing further exploration of the physicians’ behavior. Patients have no way of knowing whether their doctor’s judgment has been compromised, and doctors might be tarnished by spurious accusations.

Medical boards, which normally pursue tips or complaints of wrongdoing, do not routinely scan for such cases. Justice Department lawyers, wary of spending more time and effort on a case, say they usually are not interested in going after lesser players.

Tony West, the assistant attorney general who oversees civil litigation nationwide for the Justice Department, declined through a spokeswoman to discuss the issue. In announcing settlements with the drug companies, however, West has said that kickbacks undermine doctors’ credibility. Medical decisions, he said in one news release, should be “guided by a patient’s needs, not tainted by illegal incentives or fraud.”

Sen. Charles Grassley, Iowa, the ranking Republican on the Judiciary Committee, said in a written statement that it takes “two sides to perpetuate this fraud” and that both need to be held accountable.

“Otherwise, regardless of how big of a civil settlement a drug company makes, the incentive to cheat the taxpayers will still be in place for those willing to take part,” said Grassley, who has led investigations into conflicts of interest in medicine.

In recent years, pharmaceutical and medical-device companies have been barraged by whistle-blower lawsuits detailing how the pursuit of profit allegedly fueled fraud and corruption.

The suits are typically filed by former employees who say the companies promoted drugs for unapproved uses or paid doctors to prescribe drugs or use medical devices. The suits seek to recover millions – even billions – of dollars spent on these products by government health programs.

For Justice Department lawyers, big drug companies make attractive targets. They are flush with profits and determined to avoid crippling legal defeats. Their bureaucratic sprawl often leaves a trail of incriminating email and memos.

The massive financial settlements they are willing to pay are often modest in light of their annual sales and profits. Zyprexa, for example, had U.S. sales of nearly $3 billion in 2010. Kadian, Alpharma’s painkiller, brought in nearly $263 million, according to IMS Health, which tracks prescription drug sales.

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U.S. doctors steeped in financial ties – drug money from Big Pharma

Monday, September 12th, 2011

Natural News – September 11, 2011

by S. D. Wells

Pharmaceutical firms in the United States are shelling out massive funds for doctors travel and entertainment expenses in hopes of boosting sales of new drugs. More than 160,000 doctors have received related payments in 2011 already.

The big push includes free samples, hospital detailing, journal ads, gifting, and the sponsoring of continuing medical education, but patients fear this all leads to doctors prescribing popular, money making drugs instead of following standard of care practices .

Pfizer, Eli Lilly, and AstraZeneca top the list of companies also spending far more on “marketing” than on research, with a total estimated $57,000 billion in overall marketing expenditures in just one year in the United States.

Pharmaceutical giants are claiming they are just trying to be open about how they conduct business, but the statements come at a time of intense scrutiny, and after several prosecutions regarding unlawful marketing practices.

In fact, some of these databases were actually set up as part of settlements of federal criminal investigations into the illegal marketing of drugs to doctors. Many companies have not released any data whatsoever, but Lilly and Pfizer combine to have paid out over 90 million dollars.

United States government agencies are preparing guidelines that will make such information mandatory by 2013. Currently there are over 80,000 pharmaceutical sales reps in the U.S. pursuing about 800,000 pharmaceutical prescribers, so it can be extremely difficult to track the money for one doctor from several sources, or to identify the largest recipients, like an entire hospital, without laborious work by a whole team of computer experts.

By 2013, new federal healthcare laws are expected to make it easier for the public to track a doctor’s payments from multiple companies; however, there may be controversial business opportunities available in the setting up and running of these supposedly transparent websites, such as PharmaShine, which was founded auspiciously by a former attorney for Merck.

Critics are complaining about the extreme conflicts of interest that arise from all the gift giving and promotional items, saying doctor’s can negatively influence the cost of medicine by recommending or prescribing brand name drugs over cheaper generics. In many instances, the reward is substantial for doctors to do exactly that. Over 380 doctors have earned more than $100,000 from drug companies in just the past two years.

But there is also a flip side to these perks. One doctor said he had to follow a slide show presentation word for word in order to receive funding for a speaking engagement promoting certain pharmaceuticals, or there would be changes made to his contract.

On top of all the other problems inherent in proper ethics and disclosure, many prominent doctors at academic medical centers have failed to disclose millions of dollars in drug company payments, and Federal prosecutors say some payments are really kickbacks for illegal or excessive prescribing. Are doctors now moonlighting as drug salesmen in order to keep the perks flowing?

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Big pharma pays US doctors $150m in 2011

Tuesday, August 30th, 2011

PMLive
August 30, 2011

A report by the Financial Times has claimed a group of pharmaceutical companies has paid doctors in the US almost $150m so far during 2011.

Prepared in conjunction with the data provider, PharmaShine, the figures show the money was paid by pharmaceutical firms, including Eli Lilly, AstraZeneca (AZ) and Pfizer, for doctors’ travel and entertainment expenses as well as education and consultancy fees.

Of those companies who have released data, Lilly is reported to have paid $48m and Pfizer to have paid $42m.

AZ, who recently launched a database containing payments made to doctors and institutions, said $24.7m was paid out in associated compensation for the second quarter of 2011, with $8.1m going to individual physicians and $16.6m going to institutions.

In a post on the company’s AZ Health Connections blog, US compliance officer, Marie Martino, gave reason as to why the company was releasing its data.

She said: “AstraZeneca believes it is important to be open about how we conduct our business, and this new reporting expands on a major initiative announced three years ago to provide greater public visibility into how we do business.”

Around 165,000 doctors have received related payments in 2011 so far, compared to 262,000 doctors who received payment in 2010.

The report comes at a time when US government agencies are preparing guidelines to make the publication of industry support for medical professionals compulsory by 2013.

This is part of ongoing US healthcare reforms as an attempt to allow better, more consistent understanding of the pharmaceutical industry’s relationship with healthcare professionals in the US.

In the UK, the Association of the British Pharmaceutical Industry (ABPI) changed its code of practice at the beginning of 2011 to help increase transparency of working practices between the pharmaceutical industry and healthcare professionals to help increase trust.

Companies will have to declare payments to healthcare professionals for services including speaker fees, advisory boards and consultancy, and sponsorship for attendance at meetings on an annual basis. The first declaration will be made in 2013 for payments made in 2012.

http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/august_2011/news/big_pharma_pays_us_doctors_$150m_in_2011

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Two High Ranking Senators – Grassley & Kohl – Question Use of Psych Drugs in Nursing Homes

Monday, August 15th, 2011

MedPage – August 15, 2011

Emily P. Walker

Click image to watch video: Psychiatric Abuse of the Elderly

WASHINGTON — Two high-ranking senators have urged the Centers for Medicare and Medicaid Services (CMS) to take a closer look at potential over-prescribing of atypical antipsychotics to nursing home residents.

There are eight atypical antipsychotics approved by the FDA to treat schizophrenia and/or bipolar disorder, including clozapine (Clozaril), aripiprazole (Abilify), and quetiapine (Seroquel).

Atypical antipsychotics are not approved to treat dementia, and must carry black box warnings that elderly people who take atypical antipsychotics have an increased risk of death, compared with those who take placebo pills for dementia.

Still, it’s clear that these drugs are being used in nursing homes to control behavioral problems related to dementia. A 2011 report from the Department of Health and Human Services Office of the Inspector General (OIG) found that 14% of all nursing home residents with Medicare had claims for antipsychotics and 88% of the atypical antipsychotics prescribed off-label were for dementia.

And in 2009 Elli Lilly, the makers of olanzapine (Zyprexa), pled guilty and paid $1.4 billion to the federal government for allegedly targeting doctors who worked in nursing homes and assisted living facilities to prescribe olanzapine off-label to elderly patients with dementia.

In their letter, Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wisc.), urged CMS administrator Donald Berwick, MD, to examine the issue of overuse of antipsychotics in nursing homes more closely. The letter is a follow-up to one the senators sent in May after the release of the OIG report, which the senators themselves requested.

The newest letter, sent Aug. 1, requests that CMS investigate what role pharmacy benefit managers — who manage prescription drug coverage for Medicare beneficiaries living in nursing homes — play in fueling the possible overuse of atypical antipsychotics in elderly people in long-term-care facilities.

Pharmacy benefits managers may receive rebates from drug companies for prescribing certain drugs, and CMS should look at their role in “unnecessarily increasing the use of antipsychotic drugs and to subsequently take action to address such practices and curb excess use.”

The letter also urges CMS to consider requiring that physicians, who off-label prescribe drugs with black box warnings to seniors, certify that a Part D provider will cover the drug.

If CMS followed the senators’ advice, Medicare payments for antipsychotics that “lack a medically-accepted indication” should be drastically reduced, the senators said.

“Taking such proactive steps will create disincentives for entities that administer pharmacy benefits to allow these practices to flourish while also providing CMS with clearer means to recoup erroneous payments,” Grassley and Kohl wrote.

A recent study found that the prescription cost for a typical antipsychotic increased from $38 to $41 between 2004 and 2008, while the price tag for an atypical antipsychotic rose from $226 to $323, the researcher found. Overall, the cost of typical antipsychotics in the U.S. was $600 million in 2008, while the cost of atypical drugs reached $9.9 billion.

That same study concluded that atypical antipsychotic use is growing, especially among seniors, and the drugs are increasingly prescribed off-label, sometimes without convincing evidence to support that use.

In 2008, 91% of the prescriptions written for atypical antipsychotics were for circumstances where the evidence for the efficacy was uncertain, the researchers found.

However, a separate study found that after the FDA issued a black box warning about the risks of using the drugs to soothe behavioral problems in dementia patients, there was a decline in prescribing the drugs to patients in the VA medical system.

http://www.medpagetoday.com/Geriatrics/Dementia/28052

 

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Harvard Expert Ties Mental Illness “Epidemic” to Big Pharma’s Agenda

Friday, July 29th, 2011

Minyanville
By Minyanville Staff
July 28, 2011

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

For any mental illness or passing mood swing that may trouble a person, the Diagnostic and Statistical Manual of Mental Disorders — better known as the DSM — has a label and a code. Recurring bad dreams? That may be a Nightmare Disorder, or 307.47. Narcolepsy uses the same digits in a different order: 347.00. Fancy feather ticklers? That sounds like Fetishism, or 302.81. Then there’s the ultimate catch-all for vague sadness or uneasiness, General Anxiety Disorder, or 300.02. That’s a label almost everyone can lay claim to.

These codes are used by doctors, psychologists, and regulators to maintain a mutual language; it’s a handy shorthand system for bureaucratic purposes. But over the past few decades, the staggering, ever-expanding influence of the ever-expanding DSM, which is published by the American Psychiatric Association, has also played a lead role in building wealth and off-label product uses for the major drug manufacturers. In an insightful essay in this week’s New York Review of Books, Marcia Angell, a senior lecturer in social medicine at Harvard Medical School and former Editor in Chief of The New England Journal of Medicine, explains how.

The medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported."

Angell’s essay is based on a review of three current books examining the psychiatric industry: The Emperor’s New Drugs: Exploding the Antidepressant Myth, by Irving Kirsch; Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America by Robert Whitaker, and Unhinged: The Trouble with Psychiatry–A Doctor’s Revelations About a Profession in Crisis, by Daniel Carlat. She also cites the DSM-IV, the most recent edition of the manual, while her review traces big pharma’s role in our current mental disorder epidemic to the DSM-III, published in 1980.

To begin, Angell describes the psychiatric profession’s backlash against a developing perception in the 1960s and 1970s that the practice was a “soft” almost pseudo science:

In the late 1970s, the psychiatric profession struck back–hard. As Robert Whitaker tells it in Anatomy of an Epidemic, the medical director of the American Psychiatric Association (APA), Melvin Sabshin, declared in 1977 that “a vigorous effort to remedicalize psychiatry should be strongly supported,” and he launched an all-out media and public relations campaign to do exactly that. Psychiatry had a powerful weapon that its competitors lacked. Since psychiatrists must qualify as MDs, they have the legal authority to write prescriptions. By fully embracing the biological model of mental illness and the use of psychoactive drugs to treat it, psychiatry was able to relegate other mental health care providers to ancillary positions and also to identify itself as a scientific discipline along with the rest of the medical profession. Most important, by emphasizing drug treatment, psychiatry became the darling of the pharmaceutical industry, which soon made its gratitude tangible.

Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

These efforts to enhance the status of psychiatry were undertaken deliberately. The APA was then working on the third edition of the DSM, which provides diagnostic criteria for all mental disorders. The president of the APA had appointed Robert Spitzer, a much-admired professor of psychiatry at Columbia University, to head the task force overseeing the project. The first two editions, published in 1952 and 1968, reflected the Freudian view of mental illness and were little known outside the profession. Spitzer set out to make the DSM-III something quite different. He promised that it would be “a defense of the medical model as applied to psychiatric problems,” and the president of the APA in 1977, Jack Weinberg, said it would “clarify to anyone who may be in doubt that we regard psychiatry as a specialty of medicine.”

When the DSM-II was published in 1980, it became “the bible of psychiatry,” writes Angell, who adds, “but like the real Bible, it depended a lot on something akin to revelation. There are no citations of scientific studies to support its decisions.”

Despite its lack of citations, that DSM named 265 disorders doctors were meant to identify by matching (or mostly matching) a list of symptoms in the book with symptoms described by a patient. The drug companies were quick to see this radical shift in psychiatry as an opportunity. From the 1980s until now, as Angell demonstrates, the drug makers have supported the move away from talk therapy to the drug therapy, which also benefits practitioners, since doling out drugs and tweaking prescriptions earns a psychiatrist more money for less time spent with a patient.

Here Angell explains how companies influence the DSM itself. The bold typeface is ours.

Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them. Of the 170 contributors to the current version of the DSM (the DSM-IV-TR), almost all of whom would be described as KOLs, ninety-five had financial ties to drug companies, including all of the contributors to the sections on mood disorders and schizophrenia.

The drug industry, of course, supports other specialists and professional societies, too, but Carlat asks, “Why do psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies?” His answer: “Our diagnoses are subjective and expandable, and we have few rational reasons for choosing one treatment over another.” Unlike the conditions treated in most other branches of medicine, there are no objective signs or tests for mental illness—no lab data or MRI findings—and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that.

Eli Lilly gave $551,000 to NAMI

In addition to the money spent on the psychiatric profession directly, drug companies heavily support many related patient advocacy groups and educational organizations. Whitaker writes that in the first quarter of 2009 alone, “Eli Lilly gave $551,000 to NAMI [National Alliance on Mental Illness] and its local chapters, $465,000 to the National Mental Health Association, $130,000 to CHADD (an ADHD [attention deficit/hyperactivity disorder] patient-advocacy group), and $69,250 to the American Foundation for Suicide Prevention.”

And that’s just one company in three months; one can imagine what the yearly total would be from all companies that make psychoactive drugs. These groups ostensibly exist to raise public awareness of psychiatric disorders, but they also have the effect of promoting the use of psychoactive drugs and influencing insurers to cover them. Whitaker summarizes the growth of industry influence after the publication of the DSM-III as follows:

“In short, a powerful quartet of voices came together during the 1980’s eager to inform the public that mental disorders were brain diseases. Pharmaceutical companies provided the financial muscle. The APA and psychiatrists at top medical schools conferred intellectual legitimacy upon the enterprise. The NIMH [National Institute of Mental Health] put the government’s stamp of approval on the story. NAMI provided a moral authority.”

And now here we are in 2011, with almost everyone we know taking two or three different mood disorder drugs. (This trend is not limited to mental disorder, mind you. See Disease Branding.)

Work started on the DSM-V in 1999, which is due out in 2013. It will contain many new disorders, such as “binge eating” and “restless leg disorder.” It will also expand existing categories by tacking on words like “spectrum” to the end of a known disorder, Angell reports. “It looks as though it will be harder and harder to be normal,” she writes.

But the curtain gets pulled back further still.

In her review of Daniel Carlat’s book, Angell calls attention to the “disillusioned insider’s” frank admission that when he prescribes a drug, his decision process is largely guesswork. Carlat’s view is that although any psychiatrist will acknowledge that he or she has had great success with mental disorder drugs for say, depression or anxiety, no doctor can say with certainty whether the drugs are working or if a placebo effect has taken effect.

[Carlat's] work consists of asking patients a series of questions about their symptoms to see whether they match up with any of the disorders in the DSM. This matching exercise, he writes, provides “the illusion that we understand our patients when all we are doing is assigning them labels.” Often patients meet criteria for more than one diagnosis, because there is overlap in symptoms. For example, difficulty concentrating is a criterion for more than one disorder. One of Carlat’s patients ended up with seven separate diagnoses. “We target discrete symptoms with treatments, and other drugs are piled on top to treat side effects.” A typical patient, he says, might be taking Celexa for depression, Ativan for anxiety, Ambien for insomnia, Provigil for fatigue (a side effect of Celexa), and Viagra for impotence (another side effect of Celexa).

As for the medications themselves, Carlat writes that “there are only a handful of umbrella categories of psychotropic drugs,” within which the drugs are not very different from one another. He doesn’t believe there is much basis for choosing among them. “To a remarkable degree, our choice of medications is subjective, even random. Perhaps your psychiatrist is in a Lexapro mood this morning, because he was just visited by an attractive Lexapro drug rep.”

Messy. And, of course, the whole system is now being exported to China and other countries where the middle class is growing and the mental health industry is still in a developing stage.

Angell’s latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

Read the rest of her essay, which examines the controversial use of brain chemistry drugs to treat children, here.

http://www.minyanville.com/dailyfeed/2011/07/25/harvard-expert-links-our-mental/

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Pharma-Funded Psychiatrists Behind Bogus Child ‘Bi-Polar’ Epidemic- Disciplined for Conflicts of Interest

Friday, July 22nd, 2011

Harvard Psychiatrists Disciplined for Conflicts of Interest

Alliance for Human Research Protection – July 21, 2011

by Vera Sherav

Psychiatrist Joseph Biederman was funded millions by Pharma while promoting child "bipolar" disorder

The primary promoters–inventors, one might say– of diagnosing children with “bipolar” disorder, who for over a decade, aggressively promoted the biopolar diagnosis and use of antipsychotics in children, were disciplined by Harvard University and its affiliated Massachusetts General Hospital.

An investigation, prompted by Sen. Charles Grassely, was conducted by Harvard University-affiliated Massachusetts General Hospital. It concluded (earlier this month) that psychiatrist Joseph Biederman and two of his proteges, Thomas Spencer and Timothy Wilens -each of who failed to disclose millions of dollars they had each received from the makers of antipsychotics, the drugs they promoted for the treatment of bipolar in children–had indeed violated the University’s/ and hospital’s conflict of interest reporting  standards.

The three wrote a mea culpa letter stating “we want to offer our sincere apologies…” acknowledging “our mistakes…”

However, no mention was made anywhere about the profound consequences of these psychiatritsts’ commercially-driven clinical recommendations. No mention about the corruption of the scientific literature, about clinical practice that deviated from the Hippocratic Oath, “First, do no harm,” nor was any mention made about the harm suffered by children whose doctors were misled about the safety and efficacy of highly toxic drugs.

Child psychiatrists and pediatricians throughout the US were guided by these exceedingly influential Harvard psychiatrists.

As Sen. Chuck Grassley noted in 2008 in the Congressional Record, “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. {But] They have also taken millions of dollars from the drug companies.”

The companies that paid them millions include: Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

The Senator brought public attention–and to Harvard University administrators’ attention–the financial conflicts of interest, “Out of concern about the relationship between this money and their research.”

Indeed, documents uncovered during litigation confirmed that the research was scientifically corrupt and commercially-driven. The New York Times reported that Dr. Biederman promised Johnson a& Johnson that a study (yet to be conducted) in preschool children who would be given the company’s antipsychotic, Risperdal (risperidone) “will support the safety and effectiveness of Risperdal in this age group.”

“The psychiatrist, Dr. Joseph Biederman, outlined plans to test Johnson & Johnson’s drugs in presentations to company executives. One slide referred to a proposed trial in preschool children of risperidone, an antipsychotic drug made by the drug company. The trial, the slide stated, “will support the safety and effectiveness of risperidone in this age group.”

Dr. Biederman was the lead author of a trial published last year concluding that treatment with risperidone improved symptoms of attention deficit and hyperactivity disorder in bipolar children.”

Another of Biederman’s Harvard ignoble disciples was Jeff Bostic, who is also at Massachusetts General Hospital. He was named in a 2009 lawsuit joined by the US Department of Justice alleging Forest Laboratories promoted its antidepressants for pediatric use without FDA approval and paid kickbacks to docs to encourage prescriptions. He received $750,000 in payments for giving talks on using these drugs in children.

Strangely, the National Institute for Mental Health, which had awarded thse psychiatrists millions of dollars at taxpayers expense. It appears that NIMH officials did not see fit to even conduct an investigation into the corruption of science and violation of federal regulations. This demonstrates a lack of professional and moral integrity at the NIMH whose administrators think nothing about the misappropriation of public money for commercially-driven, junk research.

http://www.ahrp.org/cms/content/view/828/9/

Backstory from Pharmalot:

Pharmalot

Harvard Docs Disciplined For Conflicts Of Interest

By Ed Silverman // July 2nd, 2011 // 9:03 am

Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments.

In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.”

And what is their punishment? They must refrain from “all industry-sponsored outside activities” for one year; for two years after the ban ends, they must obtain permission from the med school and the hospital before engaging in any of these activities and they must report back afterward; they must undergo certain training and they face delays before being considered for promotion or advancement (you can read their letter here).

The hospital had this to say: “A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues (read the statement). And a Harvard Med School spokesman sent us this: “We confirm that the review of their compliance with the Harvard Medical School Policy on Conflicts of Interest and Commitment has concluded, and appropriate actions have been taken.” He added that the conflicts policy was revised last year.

The sanctions result from a long-standing controversy over the explosive use of antipsychotics in children. Biederman, in particular (see photo), had been one of the most influential researchers in child psychiatry. Although his studies were small and often financed by drugmakers, his work helped fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder.

For more than a decade, Biederman and his colleagues aggressively promoted the diagnosis and use of antipsychotics to treat childhood bipolar disorder, a problem that once was largely believed to be confined to adults. But the docs maintained this was underdiagnosed in kids and the meds could be used for treatment, even though they had not been approved for most pediatric use at the time. Meanwhile, the relationships with drugmakers were never properly disclosed (back story).

And for years, payments they received from drugmakers were not thoroughly reported to university officials. Yet, millions of dollars in NIH grants, which were administered by the hospital, were awarded to the docs at the same time they were receiving money from various drugmakers that make and sell antipsychotics and antidepressants. Which ones? Eli Lilly, Johnson & Johnson, Pfizer, GlaxoSmithKline and Bristol-Myers Squibb.

At one point, Biederman pushed J&J to fund a research center at MassGen that would focus on the use of its Risperdal antipsychotic in children, well before the med was approved for pediatric use. He was then placed in charge of the institute and began a study of 40 children between 4 and 6 years old who were given Risperdal and Lilly’s Zyprexa, another antipsychotic. At the time, Harvard and MGH rules forbid researchers from running trials with drugmakers if they receive more than $10,000 from a company that makes the drug (back story).

But in June 2008, US Senator Chuck Grassley made a far-reaching statement before Congress that pulled the curtain back on the money involved. The statement is memorialized in the Congressional Record. Referring to the three docs, he said “they are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

“Out of concern about the relationship between this money and their research, I asked Harvard and Mass General Hospital last October to send me the conflict of interest forms that these doctors had submitted to their institutions. Universities often require faculty to fill these forms out so that we can know if the doctors have a conflict of interest. The forms I received were from the year 2000 to the present. Basically, these forms were a mess. My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making.”

How much were they making? At first, maybe a couple of hundred thousand dollars combined. But at his behest, the med school and hospital asked the docs to take a second look. “And this is when things got interesting. Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies.

“The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.” And as Grassley then noted, there was still more money that went unreported (to read the Congressional record, click here and then check the box for 2008 and type in the name ‘Biederman’ in the search box. Then click on ‘payments to physicians’ to read the complete statement and the chart showing payments to each doc).

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