Posts Tagged ‘Johnson & Johnson’

Justice to Pharma: “Do the Perp Walk!”

Wednesday, November 17th, 2010

PharmaExec.com – November 17, 2010

by Walter Armstrong

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next?

The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Officials had warned that they would target “repeat offenders,” and GSK certainly qualifies for that dubious distinction. The British firm has racked up some of the biggest settlements of the past decade, including $750 million in October to put to rest civil and criminal charges arising in part from a whistleblower suit filed by a quality-control cop who was fired after she advised temporarily shutting down one of its major manufacturing plants because it was routinely producing adulterated drugs (and selling some of them on the black market) between 2001 and 2005. GSK execs chose instead to look the other way. The former compliance advisor’s cut of the settlement was a record-setting $96 million.

In fact, GSK has been making headlines for all the wrong reasons this year: Prior to the whistleblower suit settlement news came the denouement of the Avandia side effects case revealing that the company had failed to disclose damaging data and otherwise misled the FDA about the diabetes drug’s heart-attack risks.

But the new charges against a former VP in its legal department and all the bad press are almost certainly coincidental, says Daniel Carpenter, a professor of political science at Harvard and leading expert on the FDA. “I am not inclined to read anything political into the fact that it is a Glaxo employee,” he says. “The real symbolic feature of this action is the general message that any criminal proceeding sends to the pharmaceutical industry, namely that the FDA general counsel is now willing to use criminal proceedings—something it has had the power to do for seven decades.” Lauren Stevens, who was said by a GSK spokesperson to be “retired,” has hired a high-profile team of defense attorneys who told the media that their client was innocent and looking forward to her day in court. Be that as it may, if convicted, Stevens could spend at least some of her retirement years in the slammer because the charges are felonies carrying lengthy prison sentences.

BNet’s Jim Edwards has raised the possibility on his Placebo Effect blog that the DoJ may offer Stevens immunity for spilling the beans on other misdeeds at GSK, especially those committed by top management. That lineup include, of course, several of the industry’s most powerful players: former GSK CEO Jean-Pierre Garnier; his successor in 2008, Andrew Witty; Chris Veihbacher, who was GSK’s head of US pharmaceuticals from 2003 to 2008, when he became the CEO of Sanofi-Aventis; and David Stout, the head of global pharma operations from 2003 to 2008.

But the most probable scenario, according to Pharm Exec’s legal sources, is that the DoJ has picked a first case that it is confident it can win a conviction in. And Stevens is likely merely the first shoe to drop. It is widely assumed that the coming months will offer other executives at other firms the opportunity to do a perp walk, with some insiders betting that J&J is next on deck following recent congressional hearings into the company’s recent series of OTC product recalls, including a “phantom” recall of defective Motrin during which consultants posing as consumers attempted to buy out the product.

Slammed for failing to announce an official recall in a speedy fashion, FDA deputy commissioner Josh Sharfstein told Congress last June that J&J had misled the agency about the scope of the retrieval, not to mention its bizarre counterfeit style. But when J&J CEO William Weldon took the hot seat, he countered that his firm had informed the agency of its plans.

One of the two men is lying to Congress, so this line of speculation goes, and if it’s Weldon, the FDA may be expected to pounce—calling its no. 2 a liar only adds insult to injury.

http://blog.pharmexec.com/2010/11/17/lauren-stevens-charged-with-obstruction/

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Another Psychiatric Drug, Another Potential Criminal Investigation—J&J’s Antipsychotic Risperdal

Thursday, November 11th, 2010

Wall Street Journal, November 10, 2010

by Peter Loftus of Dow Jones Newswires

Johnson & Johnson (JNJ) said it’s in discussions with the government to resolve a long-running investigation of whether it improperly marketed the antipsychotic Risperdal.

“Discussions are ongoing in an effort to resolve potential criminal and civil litigation arising from these matters,” J&J disclosed in a regulatory filing Wednesday. “Whether a resolution can be reached and on what terms is uncertain.”

J&J spokesman Jeff Leebaw declined further comment.

Risperdal, which is approved to treat schizophrenia and bipolar disorder, was once J&J’s best-selling drug, with global sales of about $4.9 billion in 2007, according to IMS Health, before its oral formulation lost patent protection and cleared the way for generic competition.

J&J has previously disclosed government inquiries regarding Risperdal and later, a newer antipsychotic, Invega, but hadn’t previously said it was in talks for a settlement.

In 2004, the Office of the Inspector General of the U.S. Office of Personnel Management issued a subpoena seeking documents regarding sales and marketing of Risperdal, as well as payments to physicians and clinical trials for the drug, from 1997 to 2002.

The U.S. Attorney’s Office in Philadelphia sent an additional subpoena in 2005, seeking information about Risperdal marketing and adverse reactions associated with the drug. Grand jury subpoenas have been issued seeking testimony from various witnesses.

Earlier this year, J&J, of New Brunswick, N.J., disclosed the government had served civil investigative demands seeking additional information about the marketing of Risperdal and Invega.

Other makers of popular antipsychotics have settled government probes of marketing practices in recent years. In April, AstraZeneca PLC (AZN) agreed to pay about $520 million to resolve Justice Department allegations that it promoted Seroquel off label, or for uses not approved by the Food and Drug Administration.

Last year, Eli Lilly & Co. (LLY) agreed to pay more than $1.4 billion and pleaded guilty to a criminal charge, admitting it promoted the antipsychotic Zyprexa for off-label uses including treatment of dementia in the elderly.

The drugs also have been linked to safety risks, including increased risk of death if used by elderly patients with dementia-related psychosis, as well as weight gain.

Several U.S. states have filed lawsuits against J&J seeking reimbursement of Medicaid funds used to pay for off-label uses of Risperdal, as well as compensation for treating beneficiaries for alleged adverse reactions to the drug.

In October, a jury in Louisiana awarded the state $257.7 million after concluding that J&J minimized the drug’s risk of causing weight gain leading to diabetes. J&J said it would appeal the verdict because the jury wasn’t properly told of applicable legal standards, and certain evidence was excluded. J&J said it didn’t violate the law.

Read the rest of the article here: http://online.wsj.com/article/BT-CO-20101110-717532.html

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Jury took little more than three hours to decide antipsychotic drug maker sent out false & misleading information

Saturday, October 23rd, 2010

LawyersandSettlements.com, October 22,2010

by  Brenda Craig

It took the jury a little more than three hours to decide that Ortho-McNeil-Janssen and its parent company Johnson & Johnson had sent out false and misleading information about the anti-psychotic drug Risperdal. The jury set monetary damages at $257 million. “It is one of the largest verdicts in the St. Landry Parish and one of the largest in Louisiana in a case such as this,” says attorney Patrick Morrow who handled the case on behalf of the state.

Don’t Mess with Louisiana’s MAPIL LawThe money will go to the state of Louisiana’s anti-medical fraud and kickback law known as Medical Assistance Program Integrity Law (MAPIL).

The case began six years ago when the FDA ordered a label change for anti-psychotic drugs, including Risperdal, because of the relationship between the drugs and diabetes mellitus.” Janssen agreed to the label change, but at the same time it sent out a letter distinguishing Risperdal from the other drugs,” says Morrow. “They claimed it had a lower risk of diabetes.”

When the FDA discovered this, it sent out a letter warning that Janssen’s letter of November 10, 2003, was false and misleading,” says Morrow.

“Under Louisiana’s Medical Assistance Program Integrity Law (MAPIL), anyone who attempted to defraud or cause false and misleading information to disseminate, you are subject to civil monetary fine,” says Morrow.

According to the evidence, Janssen made some 27,000 phone sales calls to doctors and sent hundreds of “dear doctor letters” downplaying the diabetes link to Risperdal.

Each event, according to the law, could be considered a separate violation with a penalty of zero to $10,000.

“The jury found that there were 35,542 violations and they assessed a penalty of $7,250 for each violation,” says Morrow. “That’s how the $257 million judgment was determined in which Janssen was 90 percent at fault and Johnson and & Johnson was 10 percent at fault.”

Following the jury’s decision, Louisiana’s Attorney General Buddy Caldwell issued a statement saying that “this verdict sends a loud message to those who knowingly try to defraud the system. Those who deceive the state must pay.”

Read the rest of the article here: http://www.lawyersandsettlements.com/articles/15242/interview-patrick-morrow-ryan-bassett.html

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Drug Companies Hire Troubled Doctors As Experts

Wednesday, October 20th, 2010

NPR is investigating how pharmaceutical company payments to physicians are influencing physician prescription practices in partnership with ProPublica, an independent, nonprofit newsroom that produces investigative journalism in the public interest.

This collaboration also includes The Boston Globe, the Chicago Tribune, PBS Nightly Business Report and Consumer Reports.

Pfizer Headquarters in New York City

Mark Lennihan/AP— Pfizer, one of the largest drug makers in the U.S., saw $27.8 billion in sales in 2009. Seven drug companies, including Pfizer, have disclosed information about doctors who receive payment for speaking fees related to products they sell.

by NPR Staff and ProPublica

October 19, 2010Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of the companies’ drugs.

But an investigation by ProPublica has uncovered hundreds of doctors receiving company payments who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.

To vet the industry’s handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. The companies include Lilly, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.

Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.

That is something not all companies do.

“Without question, the public should care,” said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. “You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn’t displayed good judgment in the past?”

ProPublica senior reporter Charles Ornstein detailed the findings with Morning Edition‘s Renee Montagne.

NPR: Tell us a little about the database. What have you found, and who’s on it?

Charles Ornstein, ProPublica: For many years, the pharmaceutical industry has been paying doctors to speak and consult on their behalf, but the names of those doctors have largely been a secret. So, for the first time we’re seeing from the companies who they’re paying for. Now we have a chance to take a look at their backgrounds and what they’re doing for the money.

What are these 17,000 doctors listed in the database doing for the seven drug companies that have released information?

The drug companies rely on doctors to speak locally and travel around the country to educate other doctors about the risks and benefits of the drugs. And they can get paid a lot of money. In our database we found that there were 384 doctors who, over the course of just the past 18 months, have received at least $100,000 from the drug companies that have reported so far.

What kind of money are we talking about, and what is that buying the drug companies in the way of sales?

We’re talking about big money. Just from these seven companies, they’ve paid out more than $257 million in the past 18 months, and remember not all of these companies have even disclosed their payments for that whole period of time, so it’s likely going to be substantially more, just for these seven companies.

What do they get for it? They wouldn’t be spending this kind of money if they weren’t getting returns from the perspective of increasing their brand in the market, letting doctors know about it, encouraging them to prescribe it. They say that doctors’ success at increasing prescriptions is not a means in which they’re measured, but some of the lawsuits against the industry have said that prescriptions and return on investment absolutely play a role.

And you have found among those doctors a few who have backgrounds that are a bit shocking, especially considering they’re representing these drug companies and, in a sense, representing themselves as experts.

If you take a look at the pharmaceutical company websites, you see that they take great pride in that they’ve recruited the top names in the field, the leading experts and academicians to speak on behalf of their products and consult with them, and when you start looking at the backgrounds, you find some, indeed, are the top names in their fields. But some you can’t find any information about.

We found several dozen of the top speakers did not have board certifications — which means they were not certified in their medical specialties — and then we found more than 250 doctors who had some type of sanction taken against them by a state medical board. And we just looked at a sampling of states.

Some of the discipline was really quite serious. The Ohio Medical Board, for example, voted a couple of years back to revoke the license of William David Leak, whom they accused of performing unnecessary nerve tests on 20 patients and subjecting some to an excessive number of invasive procedures. Dr. Leak is appealing the penalty, and his license is still active, but since 2009 he has received $85,000 from Eli Lilly and Co.

Another one is a hospital disciplinary case out of Georgia — the state appeals court in Georgia in 2004 upheld a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. He’s an anesthesiologist, and he admitted to giving young female patients rectal and vaginal exams without documenting why. He had also been accused of exposing women’s breasts during medical procedures, and when he was confronted by a hospital official, he said, “Maybe I am a pervert; I honestly don’t know.”

Dr. Leak did not return our phone calls, but I did talk to Dr. Taylor. He said that these incidents happened long ago, that they were old news and happened in the 1990s and didn’t want to talk about them, so he didn’t comment one way or the other, but he did say that nobody raised any issue one way or the other about his medical practice. And that’s really what was most important here — that his medical practice was not called into question.

The Survey Says…

Consumer Reports conducted a survey about the promotional activities of doctors on behalf of pharmaceutical companies.

The survey, conducted in October 2010, included 1,250 randomly selected adults in the U.S.

Highlights are below:

Some doctors take payments from drug companies in exchange for promoting the benefits of those companies’ drugs to other doctors in presentations at conventions and conferences.

Do you approve or disapprove of doctors taking such payments in exchange for promoting specific drugs to other doctors?

CR Survey Q4

Over the past five years, have you been told by a doctor you saw for medical treatment that he or she has taken payments from drug companies?

CR Survey Q5

Would you feel comfortable asking a doctor who is about to prescribe a drug for you if he or she has taken payments from the drug company that manufactures that drug?

CR Survey Q6

In general, how concerned would you be about the quality of treatment or advice you would get from a doctor who took payments from drug companies? Would you be …

CR Survey Q8

In your opinion, how often do you think doctors who take payments from a drug company would be biased enough by the money taken to prescribe that company’s drug even if that drug was no better and/or more expensive than an alternative drug that was available? Would you say …

CR Survey Q10

So put it in perspective. Of all of these doctors — and you’re really talking tens of thousands doing speaking — what does this represent? A few bad apples?

When we spoke to experts about this, what came up was that Pharma essentially has their choice — they get to pick the best of the best, and they have the pick of the litter. What one Yale professor told us is that the public definitely should care, because just as you wouldn’t want your child learning from a bad teacher, you wouldn’t want your doctor learning from a bad doctor. And if that person has displayed bad judgment in the past, what does that portend for what they may be speaking about when they are talking in front of doctors?

When you presented these findings about these doctors who had some real problems in the past to the drug companies, what did the companies say to you?

We asked the drug companies how they screen their doctors, because we felt that was a really important question. For the most part, they said that they relied on the doctors to tell them if they ran into trouble, or they checked federal databases to see if their misconduct had barred them from participating in federal health programs. But we didn’t find but two of the companies that said they checked state medical board websites to see if the doctors were disciplined in those states.

Did any of them suggest they were going to change?

The companies said that they’re certainly going to look into the doctors that we brought to their attention, and they also said they would be looking at their practices. So I think time will tell whether they take a more comprehensive look at the doctors before they hire them to go out and promote their products.

In the story you wrote for ProPublica.org, you talk about doctors who defend their speaking fees as purely educational. In some cases these are experts who go to rural areas where doctors can’t always attend conferences or meetings of experts. Is it the case that some of these payments to doctors for speaking about these products are actually doing some good?

Absolutely. I think one thing that can’t get lost here is that pharmaceutical products have been innovative and have saved lives and provided treatments for diseases that in the past there haven’t been treatments for. So without question, some drugs are absolutely necessary, and the more patients who take them, the better off society will be.

I think the question that some folks have raised is whether or not the drugs that are being excessively promoted are indeed those drugs that have really the breakthrough, the groundbreaking potential. But it does make a huge difference.

To give you an example: GlaxoSmithKline — their top drug that they’re using speakers for is a drug called Avodart, which is for enlarged prostate. And over the past five years, Avodart, which is really locked in a heated battle with another drug, has seen its sales more than quadruple and its market share double. So this has a huge effect.

I think what you hear from critics of the industry is that perhaps when they’re promoting drugs, they’re not suggesting what the alternatives could be — whether it’s watchful waiting or physical therapy or changes to diet and exercise.

In the interest of allowing patients to make some of these decisions themselves, ProPublica has compiled a database so people can search for their own doctor.

We have seven companies, and we’ve combined them all into one database, which was not easy to do. The documents they put on their websites and the databases they put on their websites are not easily analyzable and in some cases you can’t download them or even find out who the top speaker is.

So we are making available access to these doctors. You can search by state, you can search by company, you can search by doctor’s name. And we’re also letting folks have the ability to tell us if one of these doctors is their doctor, and what their experience has been with them. So this is really an opportunity to interact in a two-way conversation with the public about the doctors that work with the industry and hear what the public has to say about their experiences.

Folks will easily be able to look up the names of their doctors and pretty easily find if they’ve taken money from these seven companies.

They won’t know a couple of things. First, more than 70 companies have not yet publicly reported whom they have paid to promote their drug. You won’t see those in the database quite yet. But you also won’t know exactly what they’ve done for the money and if it’s influenced their prescription practices. And I know that we’re planning to continue our reporting in the coming months to provide additional clarity on that for the public.

What’s the use someone could practically put that information to?

We have extensively talked to experts across the country with that very question, and I think what we heard time and again was, if you see your doctor as receiving money from a company that makes your drug, it’s good to ask if there are alternatives that are less expensive, if there are alternatives that have fewer side effects, and to just exercise a degree of caution — not necessarily to distrust your doctor at all, but to ask questions to make sure that this is the drug that’s best for you.

Read the rest of this article here: http://www.npr.org/templates/story/story.php?storyId=130644774&ps=cprs

Explore the database Dollars for Docs logo

Dollars for Docs: What Drug Companies are Paying Your Doctor here: http://projects.propublica.org/docdollars/


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Johnson & Johnson to Pay $257 Million Over Antipsychotic Drug Marketing Tactics

Friday, October 15th, 2010

By Jef Feeley and Margaret Cronin Fisk

Oct. 15 (Bloomberg) — Johnson & Johnson lost a $257.7 million jury verdict in Louisiana for making misleading claims about the safety of the company’s Risperdal antipsychotic drug.

J&J officials defrauded the state’s Medicaid system by wrongfully touting Risperdal as superior to competing antipsychotic drugs and minimizing its links to diabetes, said jurors in state court in Opelousas, Louisiana.

Yesterday’s verdict is the second trial loss in a state lawsuit brought over Risperdal marketing. A West Virginia judge in a non-jury trial last year awarded $3.95 million, finding the company misled doctors about the risks and benefits of Risperdal. New Brunswick, New Jersey-based J&J appealed.

Michael Heinley, a spokesman for J&J’s Ortho-McNeil Janssen Pharmaceuticals unit, said the company is disappointed with the jury’s decision and will appeal.

“We believe the jury was not appropriately instructed on applicable legal standards and that critical and highly relevant evidence was excluded,” he said in an interview.

The jury found 35,542 violations of the state’s Medical Assistance Programs Integrity Law and imposed a penalty of $7,250 for each. The total $257.7 million verdict is the fifth- largest in the U.S. so far in 2010, according to data compiled by Bloomberg.

‘False and Misleading’

“You can’t come into Louisiana and disseminate false and misleading information,” Patrick Morrow, who represented the state, said after the verdict in a phone interview. “I’m sure this matter will be in the appellate courts for years to come. This is the first step.”

The state’s case centered on drug safety claims that J&J and Ortho-McNeil Janssen made in November 2003 correspondence to 700,000 doctors. In those letters, J&J touted Risperdal as safer than competing antipsychotics such as Indianapolis-based Eli Lilly & Co.’s Zyprexa and London-based AstraZeneca Plc’s Seroquel. Risperdal global sales peaked at $4.5 billion in 2007, declining after the company lost patent protection.

The U.S. Food and Drug Administration responded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to rival medicines.

7,604 Letters

Lawyers for the state asked jurors to hold J&J liable for the 7,604 letters it sent to Louisiana doctors and regulators making those claims along with more than 27,542 sales calls in the state made by the drugmaker’s representatives in 2003 and 2004.

The state sought a total of $351 million in damages, including penalties of $10,000 for each fraudulent claim and misrepresentation in violation of the Medical Assistance Programs Integrity Law.

Read the rest of the article here: http://www.businessweek.com/news/2010-10-15/j-j-told-to-pay-257-7-million-over-risperdal-marketing-tactics.html

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Antipschotic Drugs—Side Effects May Include Lawsuits

Monday, October 4th, 2010

The New York Times
By Duff Wilson
October 2, 2010

FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.

cover
Department of Justice Statements on the Five Major Companies Selling Anti-Psychotic Drugs:
AstraZeneca
Bristol-Myers Squibb
Eli Lilly
Johnson and Johnson
Pfizer

While the effectiveness of antipsychotic drugs in some patients remains a matter of great debate, how these drugs became so ubiquitous and profitable is not. Big Pharma got behind them in the 1990s, when they were still seen as treatments for the most serious mental illnesses, like hallucinatory schizophrenia, and recast them for much broader uses, according to previously confidential industry documents that have been produced in a variety of court cases.

Anointed with names like Abilify and Geodon, the drugs were given to a broad swath of patients, from preschoolers to octogenarians. Today, more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.

The new generation of antipsychotics has also become the single biggest target of the False Claims Act, a federal law once largely aimed at fraud among military contractors. Every major company selling the drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson — has either settled recent government cases for hundreds of millions of dollars or is currently under investigation for possible health care fraud.

Two of the settlements, involving charges of illegal marketing, set records last year for the largest criminal fines ever imposed on corporations. One involved Eli Lilly’s antipsychotic, Zyprexa; the other involved a guilty plea for Pfizer’s marketing of a pain pill, Bextra. In the Bextra case, the government also charged Pfizer with illegally marketing another antipsychotic, Geodon; Pfizer settled that part of the claim for $301 million, without admitting any wrongdoing.

The companies all say their antipsychotics are safe and effective in treating the conditions for which the Food and Drug Administration has approved them — mostly, schizophrenia and bipolar mania — and say they adhere to tight ethical guidelines in sales practices. The drug makers also say that there is a large population of patients who still haven’t taken the drugs but could benefit from them.

AstraZeneca, which markets Seroquel, the top-selling antipsychotic since 2005, says it developed such drugs because they have fewer side effects than older versions.

“It’s a drug that’s been studied in multiple clinical trials in various indications,” says Dr. Howard Hutchinson, AstraZeneca’s chief medical officer. “Getting these patients to be functioning members of society has a tremendous benefit in terms of their overall well-being and how they look at themselves, and to get that benefit, the patients are willing to accept some level of side effects.”

The industry continues to market antipsychotics aggressively, leading analysts to question how drugs approved by the Food and Drug Administration for about 1 percent of the population have become the pharmaceutical industry’s biggest sellers — despite recent crackdowns.

Some say the answer to that question isn’t complicated.

“It’s the money,” says Dr. Jerome L. Avorn, a Harvard medical professor and researcher. “When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

NEUROLEPTIC drugs — now known as antipsychotics — were first developed in the 1950s for use in anesthesia and then as powerful sedatives for patients with schizophrenia and other severe psychotic disorders, who previously might have received surgical lobotomies.

But patients often stopped taking those drugs, like Thorazine and Haldol, because they could cause a range of involuntary body movements, tics and restlessness.

A second generation of drugs, called atypical antipsychotics, was introduced in the ’90s and sold to doctors more broadly, on the basis that they were safer than the old ones — an assertion that regulators and researchers are continuing to review because the newer drugs appear to cause a range of other side effects, even if they cause fewer tics.

Contentions that the new drugs are superior have been “greatly exaggerated,” says Dr. Jeffrey A. Lieberman, chairman of the psychiatry department at Columbia University. Such assertions, he says, “may have been encouraged by an overly expectant community of clinicians and patients eager to believe in the power of new medications.”

“At the same time,” he adds, “the aggressive marketing of these drugs may have contributed to this enhanced perception of their effectiveness in the absence of empirical evidence.”

Others agree. “They sold the story they’re more safe, when they aren’t,” says Robert Whitaker, a journalist who has written two books about psychiatric medicines. “They had to cover up the problems. Right from the start, we got this false story.”

The drug companies say all the possible side effects are fully disclosed to the F.D.A., doctors and patients. Side effects like drowsiness, nausea, weight gain, involuntary body movements and links to diabetes are listed on the label. The companies say they have a generally safe record in treating a difficult disease and are fighting lawsuits in which some patients claim harm.

The cases, both civil and criminal, against many of the world’s largest drug makers have unveiled hundreds of previously confidential documents showing that some company officials were aware they were using questionable tactics when they marketed these powerful, expensive drugs.

Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.

Lawyers suing AstraZeneca say documents they have unearthed show that the company tried to hide the risks of diabetes and weight gain associated with the new drugs. Positive studies were hyped, the documents show; negative ones were filed away.

According to company e-mails unsealed in civil lawsuits, AstraZeneca “buried” — a manager’s term — a 1997 study showing that users of Seroquel, then a new antipsychotic, gained 11 pounds a year, while the company publicized a study that asserted they lost weight. Company e-mail messages also refer to doing a “great smoke-and-mirrors job” on an unfavorable study.

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data,” John Tumas, then AstraZeneca’s publications manager, wrote in a 1999 e-mail. “We must find a way to diminish the negative findings,” he added. “But, in my opinion, we cannot hide them.”

Tony Jewell, an AstraZeneca spokesman, said last week that the company had turned over all that material to the F.D.A. as part of the approval process and updated its label over the years to show the latest safety information.

Dr. Stefan P. Kruszewski, a Harvard-educated psychiatrist who once worked as a paid speaker for several drug makers, became a government informant and now consults for plaintiffs suing drug companies. Earlier in his career, he spoke at events for Pfizer, GlaxoSmithKline and Johnson & Johnson as an advocate of antipsychotics. He said one company offered him incentives of $1,000 or more every time he talked to an individual doctor about one of its drugs.

“When I started speaking for companies in the late 1980s and early ’90s, I was allowed to say what I thought I should say consistent with the science,” he recalls. “Then it got to the point where I was no longer allowed to do that. I was given slides and told, ‘We’ll give you a thousand dollars if you say this for a half-hour.’ And I said: ‘I can’t say that. It isn’t true.’ ”

Slides for one new antipsychotic drug contended that it had no neurological side effects. “They made it all up,” Dr. Kruszewski said. “It was never true.”

Read entire article:  http://www.nytimes.com/2010/10/03/business/03psych.html?_r=2

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J&J pleads guilty to illegal marketing of psychiatric drugs

Monday, September 20th, 2010

Natural News
By David Gutierrez
September 20, 2010

(NaturalNews) A subsidiary of pharmaceutical giant Johnson & Johnson (J&J) has pleaded guilty in federal court to misdemeanor charges of marketing a drug for unapproved uses.

The guilty plea comes as part of a larger, $81-million settlement signed by J&J to settle government allegations that it illegally marketed its anti-seizure drug Topamax for the treatment of conditions including bipolar disorder and drug and alcohol addiction.

U.S. law allows doctors to prescribe drugs for any use they see fit, but prohibits drug makers from actively promoting drugs for any use not specifically approved by the FDA.

According to prosecutors, J&J sought to get around this restriction through a program it called “Doctor-for-a-Day,” in which doctors would accompany sales representatives on marketing visits. These doctors would then promote Topamax for unapproved uses, allowing company employees to keep their hands clean. According to internal documents, sales representatives told doctors that the Doctor-for-a-Day could “talk to you about things I can’t talk to you about.”

Participating doctors were paid up to $3,000 per day plus expenses, with one neurologist making half a million dollars for 200 appearances.

Read entire article here:  http://www.naturalnews.com/029790_Johnson_&_guilty.html

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Big Pharma’s Next Big Thing: Antipsychotic Medicines for Preschoolers

Thursday, September 9th, 2010

BNET

By Jim Edwards

Dr. Joan Luby, the preschool depression researcher at the center of a New York Times article that failed to mention her past research was funded by Johnson & Johnson (JNJ), Shire (SHPGY) and AstraZeneca (AZN), is currently testing the antipsychotic Risperdal on autistic children aged 30 months to 5 years old, according to the ClinicalTrials.gov database. Although the study is not funded by Janssen, the unit of J&J that makes Risperdal, it nonetheless typifies a new field of drug research: The use of mood-altering pharmaceuticals on the very, very young.

The NYT piece investigated the development of preschool depression as a diagnosis. Slate, like me, found it surprising that the author did not believe Big Pharma’s interest in the field was relevant. Minyanville thought the same thing. Such research is controversial. In November 2008, the FDA said antipsychotic drugs were over-used in children and that more should be done to discourage doctors from treating unruly kids with powerful drugs.

Luby — who also believes that certain antidepressants may be effective in children, according to this press release — is just one researcher looking at extending the use of antipsychotics to very young kids. Here’s a study on Lithium vs. Risperdal in kids aged 7 and up. And here’s a similar trial on kids aged 6 and up. GlaxoSmithKline (GSK) is currently testing Paxil on 7-year-olds despite that medicine’s well-document propensity to trigger suicides in young patients.

The reason the FDA has warned against use of these drugs in kids is twofold: First, many of these products are not approved for use in children. Risperdal — the product in the Luby study of 30-month olds — is only approved for use in autistic children older than 5; and for schizophrenics older than 13. Eli Lilly (LLY)’s competing antipsychotic Zyprexa is not indicated for anyone below the age of 13.

Read the rest of this article here http://www.bnet.com/blog/drug-business/big-pharma-8217s-next-big-thing-antipsychotic-medicines-for-preschoolers/5624?tag=content;drawer-container

To see what side effects doctors, pharmacists,  health care providers and consumers have reported to the US FDA regarding antipsychotics and antidepressants on children (including 0-1 year olds) search CCHR’s decrypted FDA Medwatch reports here http://www.cchrint.org/psychdrugdangers/medwatch_psych_drug_adverse_reactions.php

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People & Power—Drug Money

Tuesday, August 17th, 2010

A 23 minute TV expose on Big Pharma by ALJAZEERA (see video at bottom of this page)

This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

  • “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.
  • Lewis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”
  • Sharon Ormsky, FBI Financial Crimes Unit states, “Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% of that is believed to be siphoned off into fraud—that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s  top ten pharmaceutical companies for fraud.  Investigations are ongoing against another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

This is one of the best exposĂ©’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

http://www.youtube.com/watch?v=1TwdsYVHjGA&feature=player_embedded#!

This is one of the best exposĂ©’s on Big Pharma we’ve seen:

People & Power —Drug Money, produced by ALJAZEERA.  This piece pulls no punches exposing the rampant fraud, fatal drug side effects, off label marketing, criminal practices  and “absolutely jaw dropping” payouts Pharma makes to psychiatrists/doctors.

* “There is so much money to be made in stealing from the United States Healthcare system,” says Patrick Byrnes, Taxpayers Against Fraud.

* Louis Morris, US Department of Health states, “One of the things we are now looking at is going after the executives in these companies and holding them personally accountable.”

*Sharon Ormsky, FBI Financial Crimes Unit states,  ”Pharmaceutical fraud is one of our top three threats — everybody is touched by these frauds in the extent that when you look at the billions of dollars that go into healthcare for the United States, a good percent,  3-10% is believed to be siphoned off into fraud that’s  money that  could be going to very needy patients.”

Now the U.S. government is fighting back.  In the last two years alone, the  government has fined six of America’s 10 pharmaceutical companies for fraud.  Investigations are ongoing into another three.  In this period the industry has had to pay out over 5 billion dollars in fines, and topping the list is drug giant Pfizer, having recently settled civil & criminal charges resulting in $2.3 billion dollars —the biggest fraud case, the biggest criminal case, the biggest false claims act in U.S. history.   ALJAZEERA also exposes Pfizer’s “interesting way of doing business.  Witnesses in the case revealed just how the company persuaded doctors to prescribe its drugs. It entertained them in strip clubs, it told them that the blues teenagers feel when they don’t make the football team was signs of treatable depression and it paid them to endorse Pfizer drugs. One doctor received $150,000 in a year.

Also highlighted is the current scandal regarding antipsychotic drugs, including state law suits, dangerous documented side effects and how federal investigators are now looking into claims drug company Johnson & Johnson illegally marketed their antipsychotic drug Risperdal to children, paying “some of the most influential doctors in the field” in order to accomplish this.  And leading that pack sits none other than the  [now] infamous psychiatrist Joseph Biederman, who has been “credited” with the huge increase of children prescribed psychiatry’s most powerful/dangerous drugs, antipsychotics, while receiving millions in Pharma kickbacks that he failed to disclose.   Biederman is shown on tape being questioned under oath, and when asked “What rank are you?” Biederman responds, “Full Professor.” When asked “What comes after that?” Biederman responds, “GOD.”

This is a 23 minute expose well worth watching.

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Heavy Doses—Drug Company J&J Pays Docs Millions for “speaking & consulting gigs”

Friday, July 9th, 2010

Portfolio.com
By Brett Chases
July 9, 2010

Speaking and consulting gigs for drug companies can be lucrative for doctors.

Birmingham, Alabama, psychiatrist James E. Parker was paid more than $21,000 in speaking fees between January and March by a Johnson & Johnson company that sells mental health drugs.

Patricia Quinn, a retired Washington, D.C., physician and expert on attention deficit hyperactivity disorder, received more than $26,00 in the same period for consulting and speaking fees paid by a J&J company that markets Concerta, a leading drug for the condition.

The payments are part of just-released disclosures by J&J, which is following Pfizer Inc. and GlaxoSmithKline Plc in making public the amounts of money it pays physicians for speaking, consulting and conducting clinical trials.

Unlike other drug companies, J&J didn’t aggregate the total payments but the Wall Street Journal tallied the sum to be around $2.85 million in payments in the first quarter. J&J has a large medical device division and it pledges to divulge doctor payments for that business by next year. In three years, drug and device companies will be required to report such payments to the government as part of the new health reform law.

The financial relationships between doctors and health products companies are being scrutinized more closely by critics, Congress and the Justice Department. Pfizer’s decision to reveal its payments wasn’t voluntary. It agreed to do so as part of a $2.3 billion fraud settlement with the government. The company was accused to pushing docs to prescribe medicines for unapproved uses.

Read entire article:  http://www.portfolio.com/views/blogs/heavy-doses/2010/07/09/johnson-and-johnson-pays-doctors-millions-in-first-quarter

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