Archive for October, 2010

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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Psychiatrists Dominate “Doctor-Dollars” Database Listing Big Pharma Payments

Friday, October 22nd, 2010

Medscape, October 22, 2010

Shelley Wood and Robert Lowes

October 22, 2010 — Psychiatrists dominate a list of physicians receiving the most in payments from pharmaceutical companies, according to a free, interactive database of such payments launched by investigative journalism group ProPublica, in partnership with other US media outlets

So far, the database includes payments made by 7 of the biggest pharmaceutical companies — some of which the US Department of Justice has required to disclose physician payments as part of settlement agreements over illegal drug marketing — which account for a boggling $258 million in payments to roughly 17,700 physicians. The plan is to add 70 more companies.

Any US physician is searchable by name in the database.

“Receiving payments isn’t necessarily wrong,” says the homepage for the Dollars for Docs, “but it does raise ethical issues.”

The payments covered by the project include fees for such items as speaking, consulting, meals, and travel; the different types of payments from different companies have been compiled, streamlined, and tallied by ProPublica.

The 10 highest-paid physicians in 2009 to 2010 for each of the 7 companies are listed on the site, spanning all medical disciplines.

Endocrinologist Firhaad Ismail, MD, from Las Vegas, Nevada, ranked number one in pharmaceutical industry compensation, receiving $303,558 from GlaxoSmithKline, Eli Lilly, and Merck. Dr. Ismail did not return messages left with his office requesting an interview.

Top-Paid Psychiatrist Says Payments Do Not Cloud Clinical Judgment

ProPublica researchers also compiled a list of physicians who were paid more than $100,000 (typically from more than 1 company) during the past 18 months, turning up 384 names, including 41 who earned more than $200,000 through speaking or consulting arrangements and 2 who earned more than $300,000 from 1 or more of the 7 companies.

More psychiatrists are listed in the database than any other kind of specialist. Of the 384 physicians in the $100,000 group, 116 are psychiatrists. Leading all psychiatrists was Roueen Rafeyan, MD, in Chicago, Illinois, who received $203,936 from Eli Lilly, AstraZeneca, Johnson & Johnson, and Pfizer, mostly for professional education programs.

In an interview with Medscape Medical News, Dr. Rafeyan said that compensation from pharmaceutical companies does not cloud his clinical judgment at the expense of patients.

The day I’m influenced by that is the day I’m not fit to practice medicine,” Dr. Rafeyan said.

He noted that the majority of the drugs he prescribed were generics. “If someone looked at my prescribing patterns, it would be the opposite of the [pharmaceutical] money I receive,” said Dr. Rafeyan, an assistant clinical professor at Rush University Medical Center in Chicago.

Dr. Rafeyan said that although the extra income is always welcome, patient well-being was his prime motivation to talk to other physicians about brand-name psychiatric drugs. “When you educate other physicians, hopefully 1 patient will benefit from it.”

When asked how he found the time to earn more than $200,000 as a pharmaceutical company educator over 18 months, Dr. Rafeyan said, “I work very hard, like many other physicians. None of us have 40-hour work weeks.”

Dollar Value of Psychiatric Drugs Is Enormous

The preponderance of psychiatrists on the ProPublica list may reflect the proportion of prescription activity involving psychiatric drugs. In 2009, the dollar value of antipsychotic drugs came to $14.6 billion, topping all other therapeutic classes, according to research firm IMS Health. Antidepressants occupied the number 4 spot on the list, valued at $9.9 billion.

IMS Health put the total US prescription market in 2009 at $300.3 billion.

Carol Bernstein, MD, president of the American Psychiatric Association, told Medscape Medical News that the thorny issue of pharmaceutical industry compensation went beyond her specialty.

People with high-profile, high-visibility [positions] sometimes get carried away.

“Academic medicine needs a different relationship with the pharmaceutical industry,” she said. Physicians must find new ways to facilitate the development of new drugs that do not compromise their ethics or patient care.

“People with high-profile, high-visibility [positions] sometimes get carried away,” she said.

Research has shown, Dr. Bernstein added, that heavy pharmaceutical marketing indeed influences physician prescribing.

Read the rest of the article here:  http://www.medscape.com/viewarticle/731028

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Psychiatrists Are Major Target for Drug-Maker Money

Friday, October 22nd, 2010

WFAE 90.7 FM
Julie Rose
Thursday October 21, 2010

Earlier this week, NPR and ProPublica released a database showing the flow of money from seven top drug makers to the doctors who prescribe those drugs.  WFAE’s Julie Rose takes a closer look at one type of doctor getting a big slice of that money. Psychiatrists are only about 7 percent of all doctors in the country, according to a 2008 survey funded by the Robert Wood Johnson Foundation.

But when you look at the doctors who made more than $100,000 consulting and speaking on behalf of major drug companies in the last 18 months, psychiatrists are more than a quarter of the list.

What is it that makes the health of the mind such an attractive target for pharmaceutical money?  Adam Linker of the NC Justice Center has this theory.

“Some of these drugs are the most expensive,” notes Linker.  “They’re some of the best-sellers and they’re driving some of the increases in drug costs.  I think drug companies want to keep increasing those prescriptions.”

The anti-psychotic drug Zyprexa, for example, is Eli Lilly’s top-selling product. AstraZeneca has a top-seller, too. No surprise, then, that those two companies cut some of the largest checks to psychiatrists.

Most doctors deny their drug-company consulting work has any effect on the medicine they prescribe.  But numerous studies have shown there is a link.

Read the rest of the article here:  http://www.wfae.org/wfae/1_87_316.cfm?action=display&id=6578

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Mental health clinics targeted in Medicare fraud crackdown

Friday, October 22nd, 2010
Agents raid chain of mental health clinics accused of filing false claims

Miami Herald

By Jay Weaver
October 22, 2010

Even by Miami-Dade’s reputation for Medicare fraud, the indictment was a shocker:

American Therapeutic’s patients could not feed themselves or control their own bodily waste.

Many lacked the mental capacity to respond to counseling; instead they simply stared at walls or watched TV.

An employee complained that those patients should be ineligible for Medicare since they could not benefit from treatment.

She got fired.

That launched whistle-blower and criminal investigations that led to the Justice Department’s takedown Thursday of Miami-based American Therapeutic Corp., the nation’s largest chain of mental health clinics.

Federal prosecutors charged the company and four top executives with scheming to fleece $200 million from the taxpayer-funded healthcare program.

“Some of the patients were not even cognizant of where they were or what was going on around them,” said Lanny A. Breuer, assistant attorney general of Justice’s criminal division.

“Other patients were simply there to make money, through kickbacks,” said Breuer, who flew to Miami for a news conference at the U.S. attorney’s office.

At the crack of dawn Thursday, federal agents arrested Lawrence S. Duran, 48, of North Miami, the owner of American Therapeutic; Marianella Valera, 39, the company’s CEO; Margarita Acevedo, 40, the firm’s marketing director; and Judith Negron, 39, vice president of a subsidiary.

Since 2003, Medicare paid the chain a total of $84 million — taxpayer money that authorities say was mostly blown on luxury items, including Duran’s 2009 Maserati Quattroporte and Valera’s bayfront condo at the Opera Towers. Duran and Valera also spent the money on trips to Switzerland, Dominican Republic and Cuba.

The feds obtained court orders to freeze the employees’ personal and corporate bank accounts in an attempt to salvage possibly a few million dollars of the Medicare payments.

The indictment charged American Therapeutic, a seven-clinic chain, and its subsidiary, Medlink Professional Management Group, Inc., and the four employees with conspiring to defraud Medicare for group therapy sessions that were either unnecessary or not provided to patients, many suffering from Alzheimer’s or dementia.

The ring is also accused of paying bribes to recruiters who tapped into an endless supply of patients from assisted-living facilities and halfway houses, who also received kickbacks for the referrals.

The accused ringleaders, Duran and Valera, instructed doctors and employees to alter patient charts, medical diagnoses, therapy session notes and drug medications to make American Therapeutic’s thousands of claims look legitimate to Medicare, according to court documents.

Whether they harmed any patients is the subject of “an ongoing investigation,” Breuer and other Justice Department officials said.

On Thursday morning, 160 agents from the FBI and Health and Human Services raided American Therapeutic’s clinics at 1801 NE Second Ave. and other South Florida locations. They carried out boxes of records, computers and other evidence and loaded them into vans. Patients who showed up for their daily mental health sessions were asked to leave.

IN COURT

Later Thursday, in federal court, the four defendants had their first appearance. They were dressed in Euro-style T-shirts and pants — though they were cuffed at the wrists and ankles.

Jennifer Saulino, a Justice Department attorney, recommended no bond for Duran and Valera and $1 million bail for Negron and Acevedo.

“This was the largest Medicare fraud scheme in this district, and, as you know, Your Honor, that’s saying quite a lot,” she told Magistrate Judge Edwin Torres. “This was a big fraud, and these were big players.”

Acevedo was granted a $350,000 bond. The other three will have pretrial detention hearings on Tuesday.

The scope of South Florida’s alleged $200 million case surpassed that of a vast network of Armenian gangsters and their associates charged last week with operating phantom healthcare clinics to try to cheat the federal program out of $163 million.

U.S. authorities touted that case as “the largest Medicare fraud scheme ever perpetrated by a single criminal enterprise,” with 73 people charged in New York, Los Angeles and other cities.

The Miami indictment signaled the Justice Department’s latest assault against rampant Medicare fraud in South Florida.

U.S. Attorney Wifredo Ferrer called mental health fraud the latest scam in a series involving medical equipment, HIV infusion and home diabetic services.

Authorities said the magnitude of such fraud is eye-opening: More than 100 Florida mental health centers, mostly in Miami-Dade, submitted $425 million in bills to the Medicare program last year.

In turn, Medicare paid $171 million to the Florida clinics, with almost all of that money going to mental health operators — such as American Therapeutic — in Miami-Dade, Broward and Palm Beach counties.

Indeed, reimbursements to South Florida clinics alone accounted for 56 percent of Medicare’s entire payments to mental health centers nationwide last year, according to the agency’s records.

American Therapeutic is not only Medicare’s highest biller of mental health services in the country, but Duran also has been active in a Washington, D.C., lobbying group called The National Association for Behavioral Health.

A video of Duran’s visit in January to the congressional office of U.S. Rep. Ileana Ros-Lehtinen, R-Miami, was posted on You Tube, in which he talked about protecting mental health services under the healthcare reform legislation passed by Congress this year.

Also, Duran and two other South Florida healthcare businessmen were pictured with the congresswoman in a photo posted on the Behavioral Health’s website.

Confronted with an onslaught of suspicious claims, Medicare administrators began placing many suspect Miami-Dade mental health clinics on what is known as “prepayment review.”

That means payments are frozen until Medicare can verify that doctors prescribed the services, the clinics provided the counseling sessions, and patients received and benefited from them.

Without confirmation, the clinics aren’t paid, which has led to some shutting down.

Read the entire article here:  http://www.miamiherald.com/2010/10/22/v-fullstory/1885571/mental-health-clinics-targeted.html

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Miami Psychiatrist Who Wrote 96,685 Prescriptions for Psychiatric Drugs in 21 Months Prompts Calls for Federal Investigation

Wednesday, October 20th, 2010

Lexington Herald Leader, October 20, 2010

By MAR CABRA AND JOHN DORSCHNER

Based on the huge numbers of prescriptions written by a Miami psychiatrist, Sen. Charles Grassley, R-Iowa, is continuing to pressure federal officials to investigate why some doctors write stunning numbers of scripts for tax-funded Medicare and Medicaid programs.

In his latest volley, a letter sent Wednesday to Kathleen Sebelius, secretary for the U.S. Department of Health and Human Services, Grassley demanded exact answers to three pointed questions about what her department is doing to address the problem.

“The federal government has an obligation to figure out what’s going on here,” Grassley said in a statement e-mailed to The Miami Herald Wednesday. “The taxpayers are footing the bill, and Medicare and Medicaid are already strained to the limit. These programs can’t spare a dollar for prescription drugs that aren’t properly prescribed.

“The conclusion might be that there isn’t any fraud, but it’s important to reach a conclusion one way or the other and fix whatever is broken,” Grassley said.

In the Sebelius letter, Grassley said his concern was triggered by a “Florida provider who wrote 96,685 prescriptions for mental health drugs in a 21-month period.” The letter did not identify the provider, but state records confirm that it is Fernando Mendez-Villamil, a psychiatrist with an office on Coral Way.

State Medicaid records independently obtained by The Herald show that over a two-year period Mendez-Villamil wrote almost twice as many prescriptions for mental health drugs as the No. 2 Medicaid prescriber in the state.

Robert N. Pelier, attorney for Mendez-Villamil, said Wednesday he and his client learned about the letter only after receiving a call from The Herald. He said the psychiatrist tried to reach Grassley’s office when his prescription numbers were made public to give the proper context to the doctor’s prescription patterns and “why he is an intricate part in the community.” Pelier said he had not received a response from Grassley.

“What my client believes is that he’s been a victim of this health care debate,” the attorney said. “The majority of his prescriptions are expensive because they’re cutting-edge pharmaceuticals.”

Pelier said Mendez-Villamil has been recently terminated from the Medicaid program and is now seeing some patients for free. “We are pursuing legal action against AHCA Agency for Health Care Administration for the improper termination of doctor Mendez-Villamil from Medicaid,” he said. The lawsuit was filed late July.

Meanwhile Ryan Wiggins, spokesman for the Florida Office of the Attorney General, confirmed there is an ongoing investigation into Mendez-Villamil that involves “complicated issues of medical necessity … We cannot comment further at this time.”

Last December, Grassley’s office calculated Mendez-Villamil’s numbers meant “this physician wrote approximately 153 prescriptions each and every day, assuming he did not take vacations.”

Earlier this year, Mendez-Villamil told The Herald that he works long hours and often gives each patient four or five prescriptions, accounting for the large numbers.

In April, Grassley wrote to all state Medicaid agencies requesting data about certain mental health drugs. On Wednesday, Grassley’s office said the Florida provider identified by The Herald as Mendez-Villamil had the second-highest number of prescriptions in the nation for the generic form of Xanax in the data they analyzed.

The Wednesday letter also noted that the top Zyprexa provider in Florida wrote 1,356 prescriptions for 309 individuals in 2008 and 1,238 for 236 in 2009. The Herald independently verified from state data that this provider was Mendez-Villamil, and he wrote more than twice as many Zyprexa prescriptions as the No. 2 provider in the state.

“I want to be clear that none of the information provided suggests any illegal or wrongful behavior,” Grassley wrote. But such huge numbers “might also suggest overutilization or even health care fraud. The only way to determine veracity is through appropriate oversight by Health and Human Services and continued monitoring by the Congress and the Senate Finance committee.”

Read more: http://www.kentucky.com/2010/10/20/1488418/grassley-seeks-probe-into-numbers.html#ixzz12xQPjZzm

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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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When Big Pharma Breaks the Law—Prosecute the CEO

Tuesday, October 19th, 2010

New Scientist

October 19, 2010

Avandia's manufacturer won't release all its documents about the drug (Image: Bloomberg/Getty)
(Image: Bloomberg/Getty)

Patient safety will remain at risk until big pharma’s top executives are brought to book for their companies’ actions, says Paul Thacker

THERE have been so many stories about pharmaceutical companies promoting the misuse or abuse of their drugs that the names seem to merge – Zyprexa, Seroquel, Paxil and more.

The latest case concerns GlaxoSmithKline’s Avandia (rosiglitazone), an anti-diabetes drug linked to heart attacks. Last month, the European Medicines Agency recommended its suspension from the market, while the US Food and Drug Administration made it all but impossible for doctors to write prescriptions for the drug.

With sales worth over $3 billion in 2006, Avandia was the world’s best-selling diabetes drug until May 2007, when The New England Journal of Medicine published a study linking it to heart attacks. Reporters circled, and the finance committee of the US Senate investigated, forcing GSK to hand over internal documents.

As the main investigator into Avandia for the Senate committee for the past three years, I looked closely at the documents. I was appalled. From 2000, GSK pulled out all the stops to keep the drug on the market. Not all studies were provided to regulators, and it intimidated a doctor who criticised the drug. Even though GSK is in the middle of multibillion-dollar lawsuits brought by thousands of patients, it still has hundreds of documents hidden from public view under court seal – a feature of the US system that leaves documents provided under discovery accessible only to the parties involved in the litigation.

How can we stop this? One way is to slash what pharma can spend on encouraging doctors to prescribe their drugs. Companies spend billions wining and dining doctors. For instance, Forest Laboratories’ 2004 marketing plan for its antidepressant Lexapro notes it planned to spend $34.7 million to pay doctors to give lectures to their peers, and $36 million on lunches for doctors to create “an extended amount of selling time for representatives”.

In legal settlements reached with the US government, several companies have been forced to publish databases listing monies they provide to doctors. A provision in the Health Reform Bill passed this year will from 2013 require companies to disclose payments above $10 made to doctors, and explain why. This will be available in a searchable public database.

This will help, and may shame doctors into not taking handouts, but we also need professional societies to tighten ethical requirements to stop doctors accepting pharma gifts.

A second route is to reform the continuing medical education (CME) courses doctors must take every year. Of the $2 billion spent on CME in the US, pharma funds almost half. Companies claim this has no influence on prescribing practices, but internal company documents made public by the Senate finance committee contradict this. For example, Forest Laboratories’ marketing material on Lexapro discussed how CME courses could be used to push sales of the drug.

Several universities have revised rules on industry funding. Stanford University in California now requires companies to pool their money and fund a number of activities instead of funding individual courses, as is still allowed in most medical schools. The Memorial Sloan-Kettering Cancer Center in New York has ended all commercial support for CME in 2007, without ill effects.

Third, we need to penalise executives when companies are caught committing illegal acts. Since 2004, pharma has paid over $7 billion in fines and penalties, but even these figures barely dent profits. The $2.3 billion fine Pfizer paid in September 2009 for the way one of its subsidiaries marketed Bextra, the non-steroidal anti-inflammatory drug, and three other drugs, was the biggest ever paid by a corporation in the US. Yet the fine was just 14 per cent of $16.8 billion revenue from the drugs from 2001 to 2008, little more than the price of doing business.

Paul Thacker is an investigator at the Project On Government Oversight, a non-profit organisation exposing waste, fraud and abuse in federal government. He was congressional investigator for the US Senate’s finance committee, where he was Senator Chuck Grassley’s lead investigator on Avandia

Read the rest of the article here:  http://www.newscientist.com/article/mg20827826.900-when-big-pharma-breaks-the-law-prosecute-the-ceo.html

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Doctors draw payments from drug companies: Physicians say presentations they make are educational, but critics say the practice puts financial rewards ahead of patient care

Tuesday, October 19th, 2010

Los Angeles Times

October 19,2010

by Judith Graham

Follow drug company money in Illinois, and it leads to the psychiatry department at Rush University Medical Center, a prominent headache clinic on the North Side of Chicago, a busy suburban urology practice and a psychiatric hospital accused of overmedicating kids.   In each of these settings, doctors are drawing an extra paycheck — worth tens of thousands of dollars a year or more — for speaking to other medical professionals about pharmaceutical products at company-sponsored, company-scripted events in Illinois and across the country.

The extent of these activities is only now coming to light as drug companies start publicly releasing data about their relationships with physicians, information that until now has been a closely guarded secret.

The pharmaceutical data show that 11 Illinois physicians each earned more than $100,000 between January 2009 and June 2010 from seven companies, according to a new database compiled by the national investigative news organization ProPublica. An additional 13 medical providers earned between $75,000 and $100,000, primarily for participating in speakers’ bureaus and educational forums. Most doctors received far lesser sums.

This medical moonlighting is perfectly legal but highly controversial.

Doctors and drug companies say their collaborations provide time-pressed medical professionals with much-needed education about how best to treat illnesses and how various drugs work. But other medical and policy experts say physicians involved in the activities have crossed an important line, straying into the realm of product promotion and potentially compromising their independence and patient care.

“Let’s be honest: The purpose of these talks is to influence doctors to buy a company’s drugs,” said Eric Campbell, an associate professor of health policy at Harvard Medical School.

That may raise potential problems if patients are prescribed medications that are not necessary, are needlessly expensive or are not appropriate for their conditions.

Dr. Catherine DeAngelis, editor of the Journal of the  American Medical Association, criticized the speaking arrangements, saying they posed “a conflict of interest” and threatened to put doctors’ “own financial benefit before that of the patients who trust them.”

More than a dozen physicians interviewed by the Tribune explained that they work with drug companies because they enjoy teaching other practitioners about important medications and the research behind them. None of the physicians routinely tells patients about his or her drug company-sponsored activities, and all said they believe such ties have no effect on their medical practices.

Read the rest of the article here: http://www.latimes.com/health/ct-met-doctors-drug-dollars-20101018,0,599135.story


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Prescription for prestige—Drug firms’ speaking fees flow to Harvard doctors; concerns about influence prompt new restrictions

Tuesday, October 19th, 2010

The  Boston Globe,  October 19, 2010

Liz Kowalczyk

The Harvard brand, unrivaled in education, is also prized by the pharmaceutical industry as a powerful tool in promoting drugs. Its allure is evident in a new analysis of all publicly reported industry payments to physicians.

Doctors and researchers affiliated with Harvard Medical School collected 45 percent of the $6.3 million given to Massachusetts doctors in 2009 and 2010 by seven pharmaceutical companies that disclosed their payments for parts of those years. The money was mostly for talking to other physicians about the companies’ drugs and the diseases they treat, but also for consulting on research and marketing.

“Companies value the cachet that comes with the name of a prestigious institution,’’ said Dr. Paul Appelbaum, director of the Division of Law, Ethics and Psychiatry at Columbia University College of Physicians and Surgeons. “Even though the institutions themselves are not in any way endorsing the presentations, the aura carries over.’’

The proportion of money going to Harvard doctors underscores why the medical school and its affiliated hospitals, concerned that certain speaking fees can compromise the independence of doctors, are clamping down on such payments.

It is not clear yet whether these restrictions are slowing payments to Harvard doctors, because the data reported publicly are incomplete. But one company, Eli Lilly, gave 50 percent of its payments in 2009 to Harvard doctors and just 33 percent during the first three months of this year.

Many hospitals and medical schools continue to permit doctors to participate in company speakers bureaus, and even at medical centers that largely ban the practice, the analysis — by ProPublica, a nonprofit, online investigative reporting organization, and the Globe — found spotty enforcement.

Consulting with industry to develop new treatments is considered part of an academic physician’s role. But participating in speakers bureaus, while legal, is controversial. Bureau speakers typically show groups of doctors company-created or approved slide presentations about specific drugs or diseases treated by a company’s products. Many of these talks, often held at fancy restaurants, have been moved out of state, doctors said, since last year, when Massachusetts banned doctors from eating the free dinners.

Pharmaceutical companies defend speakers bureaus as an important tool for educating doctors and say industry naturally relies on physicians from top academic medical centers because their peers look up to them.

While some doctors who gave speeches once or twice during 2009 and 2010 earned $2,000 to $3,000, more than two dozen Massachusetts psychiatrists, endocrinologists, and other specialists who gave frequent talks brought in $40,000 to $100,000 and, in a few cases, more. Dr. Lawrence DuBuske, an allergy specialist, earned the most: $219,775. The Globe reported earlier this year that he resigned from Brigham and Women’s Hospital largely because of its new speaking ban.

Partners HealthCare, which includes the Brigham and Massachusetts General and McLean hospitals, halted their doctors’ promotional speaking appearances in January because of concern that they could be perceived as company salespeople and were helping to drive up use of expensive drugs.

Dr. Brent Forester, a geriatric psychiatrist at McLean, was one of the Massachusetts physicians paid the most last year, when he made $73,100 for giving nearly 40 talks for Eli Lilly to colleagues about the antipsychotic Zyprexa and the antidepressant Cymbalta over dinners in restaurants and in doctors offices. He has resigned from speakers bureaus to comply with the new rules, but said he “never felt like a spokesperson for the company at all.’’

“It was an opportunity to educate primary-care doctors about the treatment of psychiatric conditions,’’ Forester said.

Christopher Clark, who oversees compliance for Partners, said his staff searched drug company websites and identified 31 of its physicians who had been hired for speakers bureaus. All but two agreed to resign from the bureaus.

Harvard Medical School itself is also prohibiting participation in speakers bureaus, effective early next year. Consulting payments will still be allowed, with certain restrictions, but will have to be disclosed to Harvard, which has been under pressure from Senator Charles Grassley of Iowa to better monitor its faculty’s relationships with industry.

“We must ensure the integrity and objectivity of all our activities,’’ said Gretchen Brodnicki, the medical school’s dean for faculty research and integrity, who added that the Harvard faculty is huge, about 24 percent of the state’s doctors.

The data on physician payments was compiled from the websites of Eli Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, Merck & Co., Cephalon, and the Johnson & Johnson companies by ProPublica and analyzed for Massachusetts by the Globe.

Companies reported paying about 470 Massachusetts doctors, about 200 of them Harvard faculty, a small percentage of the physicians statewide and of those affiliated with the university.

Most drug companies, however, have not publicly reported payments. The ones that have posted the information report different types of payments for different time periods, so it is not possible to draw definitive conclusions about how many doctors received payments and how much individual doctors earned.

Read the rest of this article here:  http://www.boston.com/news/health/articles/2010/10/19/mass_doctors_earn_drug_firms_dollars/?page=full

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Pfizer ends trial after widespread overdosing of children with psych drug

Monday, October 18th, 2010

NaturalNews.com,  October 18, 2010

by David Gutierrez

Drug giant Pfizer has canceled a scheduled clinical trial of its antipsychotic drug Geodon after the FDA accused it of subjecting child participants in a prior study to “widespread overdosing.”

“After careful consideration, the company decided not to proceed with the study,” Pfizer spokesperson Gwendolyn Fisher said.

Fisher said that although the company had taken “preparatory steps” toward the trial, it had decided to abandon the study in order “to meet regulatory timelines.” No patients were enrolled.

Pfizer is seeking FDA approval to market Geodon for the treatment of bipolar disorder in children between the ages of 10 and 17. An FDA panel already rejected this use once in 2009 by a vote of 10-7, expressing concern that large numbers of participants had failed to complete clinical trials of the drug. The FDA asked Pfizer for further information on the drug’s safety in children, and the company responded by launching pediatric trials of the drug.

In April, the FDA warned the company that researchers in charge of the trials were engaging in “significant violations,” including “widespread overdosing” caused by inadequate company oversight.

Five months earlier, Pfizer had agreed to pay $2.3 billion to settle a collection of federal and state criminal and civil charges that it had improperly marketed Geodon and three other drugs.

Geodon, which made Pfizer $1 billion in 2009, is already approved for the treatment of bipolar disorder and schizophrenia in adults. Its competitors AstraZeneca and Eli Lilly have already secured FDA approval to use their respective antipsychotics Seroquel and Zyprexa to treat bipolar disorder in children.

Treatment of children with antipsychotics remains a controversial practice amid growing concern over major side effects such as severe metabolic changes and weight gain.

Although Geodon’s most recent safety trial has been canceled, the company made it clear that it still plans to secure FDA approval for pediatric use of the drug.

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