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Disciplined doctors receiving pharmaceutical funds

Thursday, November 18th, 2010

San Francisco Chronicle, November 18, 2010

by Victoria Colliver

About 48 of the more than 1,730 California doctors who received money from pharmaceutical companies over the past 21 months have been the subject of disciplinary action, a database compiled by the investigative news organization ProPublica found.

While that represents less than 3 percent of the California doctors who take pharmaceutical money, the fact that drug companies are paying those doctors – some of whom have multiple disciplinary actions – for their expertise calls into question how closely these companies vet the physicians who serve as the spokespeople for their drugs.

California doctors have received $28.6 million from top pharmaceutical companies since 2009, with at least three physicians collecting more than $200,000 and 36 others making more than $100,000 for promoting drug firm products. That cash flowing from drug companies to doctors has raised ethical concerns from some observers.

“If they’re getting as much money from pharmaceutical companies as they do for being a doctor, what are they really? Are they working for a pharmaceutical company, or are they being a doctor?” asked Lisa Bero, a pharmacy professor at UCSF who studies conflicts of interest in medicine and research.

Bero also questioned why drug companies – which presumably would want medical leaders who could influence prescribing patterns – would use doctors with a history of disciplinary actions.

“Are those really the most influential physicians?” she asked. “I don’t think they’re (the drug companies) on top of this.”

Company payments

Payments to doctors and other health professionals made by Eli Lilly, GlaxoSmithKline, AstraZeneca, Pfizer, Merck, Johnson & Johnson and Cephalon, some of the world’s largest drug companies, added up to more than $281.9 million in 2009 and 2010 nationwide. The figures do not include drug samples, the cost of continuing education programs, and meals brought to doctors’ offices.

In total, 384 of the approximately 17,700 health professionals in the 30 states surveyed who received some money from drug companies in ProPublica’s database, almost all of them physicians, earned more than $100,000 apiece for their promotional and consulting work on behalf of one or more of the seven companies in 2009 through Oct. 19 of this year.

ProPublica found that the seven drug companies paid $6.7 million to 290 doctors who faced disciplinary action or other regulatory sanctions in various states.

San Francisco psychiatrist Karin Hastik, for example, took $168,658 in speaking and consulting fees from Eli Lilly, AstraZeneca and GlaxoSmithKline since 2009.

But in May, the Medical Board of California placed Hastik on probation for negligence, prescribing drugs without prior examination, and failing to keep adequate records about a patient she had been caring for since 2000. Hastik did not return calls for comment.

Dr. Gerald Sacks, an anesthesiologist with offices in Los Angeles and Santa Monica, was California’s top earner in the database, receiving $249,822 from drug companies since 2009. More than half – $150,097 – came from Pfizer.

In 2003, the state medical board cited Sacks, who did not return calls for comment, for failing to maintain adequate records of a patient he treated for back pain.

Undermining trust

While the disciplinary actions in the database vary greatly – everything from failing to maintain accurate paperwork to sexual misconduct – some experts say the very act of taking large sums of money from pharmaceutical companies raises ethical concerns.

“It undermines the trust in the doctor-patient relationship,” said Maryann O’Sullivan, executive director for the Campaign for Effective Patient Care, a nonprofit based in Fairfax. O’Sullivan said patients shouldn’t have to worry if their doctors are making medication recommendations because they are beholden to drug company money.

Officials for several of the pharmaceutical firms told ProPublica that they intended to tighten and improve their selection and screening processes in light of the disciplinary results. ProPublica provided each company with lists of all speakers who had been disciplined in the 30 states and by the U.S. Food and Drug Administration.

A survey conducted in 2004 found that more than 80 percent of physicians had some relationship with the pharmaceutical industry, ranging from accepting drug samples to collecting consulting fees and participating in paid clinical trials.

Since that time, greater attention has been placed on the relationship between doctors and drug companies, and many hospitals and medical schools have adopted rules that limit these ties.

A survey published this month in the Archives of Internal Medicine found that more than 80 percent of doctors still had industry relationships, but the level of involvement had decreased. For example, the survey found the percentage of physicians receiving payment for speaking engagements and other services dropped from more than one-fourth in 2004 to 14.1 percent last year.

Several doctors who were not the subject of any disciplinary action but did take large sums from pharmaceutical companies told The Chronicle they spoke on behalf of only those drugs they believed in and thought they were performing an important educational service for other physicians.

A teaching tool

Dr. Rona Hu, clinical associate professor at Stanford University School of Medicine, said she earned more money from speaking engagements in 2009 than usual because several drugs she prescribes became available for new uses. The psychiatrist said she has since stopped getting paid by drug firms to speak because Stanford tightened its policy regarding industry gifts to staff.

One of the top earners in Northern California, Palo Alto psychiatrist Manoj Waikar, who earned $185,875 since 2009, ended his affiliation with Stanford as an adjunct professor after the school extended its ban to adjunct staff in March.

“Speaking for drug companies is a great vehicle for me for teaching. I end up reaching more people who are eager to learn, especially in rural parts of the country,” he said, adding he does not disclose what drugs he prescribes to pharmaceutical companies so they hire him for his expertise, not because of his prescribing patterns. “As much as I loved teaching at Stanford, abiding by their rules would (keep) me from teaching as many people in as many ways as I can.”

Dr. Michael Lenoir of Oakland, who collected $112,600 from GlaxoSmithKline, said he uses his speaking engagements to visit urban and underserved areas around the country to discuss the high rate of asthma in black communities and the treatment options.

A San Francisco pain doctor who has earned $176,771 since 2009 from Pfizer and Cephalon said he doesn’t believe speaking for drug companies poses a conflict because he discloses the payments to his patients.

“So far, every patient has been OK with it,” said Dr. Wayne Anderson, adding that doctors who take money from equipment manufacturers and other medical suppliers don’t fall under the same scrutiny. “I don’t get bonus payments at the end of the month. I’m not trying to do anything secretive. I have complete transparency and honesty, and I tell people when I have been paid to promote a drug.”

About this story: It was produced in partnership with ProPublica, a nonprofit investigative news organization. To read the stories in the investigation and to search the ProPublica database on pharmaceutical company payments to doctors, go to projects.propublica.org/docdollars.

Read the rest of the article here: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/11/18/MNJU1GDLRF.DTL

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Seven Ways Medical Conflicts of Interest are Disguised

Friday, November 12th, 2010

FoodConsumer, November 12, 2010
by Martha Rosenberg

“Trust me” used to be the punch line about how a certain obscenity is uttered by Hollywood agents.

It also used to govern the conflicts of interest policies at hospitals, universities, medical schools and scientific journals about doctors’ and researchers’ financial links.

But conflicts of interest (COI) at Harvard and other universities, medical journals, professional groups and at the FDA itself have ushered in a kind of disclosure fever. In addition to the Physician Payment Sunshine Act which requires drug and device makers to report physician payments yearly, medical schools are starting to reject industry money that traditionally funded Continuing Medical Education (CMEs).

Individual doctors’ COIs have also been a problem for medical groups and journals.

The American Psychiatric Association,  in its 240 page guide to its May annual meeting, “forgot” to mention the conflicts of interest of its own president Alan Schatzberg, MD. It had to print them on the newsletter circulated the third day of the meeting. Nor were names even alphabetized for easy information retrieval. (Schatzberg is financially linked to Eli Lilly, GSK, Merck, Pfizer, Forest, Takeda, Sanofi-Aventis and eight other companies.)

Joan Luby, MD, a pediatric depression expert says in the Archives of General Psychiatry in March she didn’t disclosure lectures she gave for AstraZeneca and other pharma ties “because they were not relevant to the subject of the article.” Maybe that’s why the New York Times magazine didn’t disclose Luby’s links in the August “Can Preschoolders be Depressed?” and five Wyeth links in April’s “The Estrogen Dilemma.”

And statin investigator, Harvard’s Paul Ridker, MD, apologized to JAMA readers in 2006 for an incomplete financial disclosure for an article about cardiovascular clinical trials. He thought he only had to report funding for the “study at hand” and had omitted mentioning funding from AstraZeneca, Bayer, Novartis, Roche, Sanofi-Aventis and five other pharmaceutical companies.

Disclosure is especially tricky for medical journals whose lifeblood is often drug ads and reprints of article for drug companies to pass out to physicians.

Here are some of the ways conflicts of interest are finessed.

1) Omnibus disclosure. All of a study’s authors are listed with all the pharma links in one block of solid type. Who goes with whom? You’ll never know — but the author with no links sure isn’t happy about shared guilt.

2) Initials. “R.L.T. has consulted for Merck” is set in 8 point type at the end of the article. Will readers return to the study’s start, five pages ago where there are eight authors, four with first names that begin with R?

3) Disclosures You Have To Work For. COIs of CME faculty are often given online but the information is tucked away in a pull-down, scroll menu. It is user-unfriendly like the drug side-effects found on the scrolling ads on the same site.

4) One Disclosure is Enough. When a previous article is cited in journal letters sections, the author disclosures are said to “be found with the original article.” Surely you have that issue, published four months ago, on your desk.

5) Protective Coloring. Disclosures of drug company links are embedded between government grants and charitable foundations. Government grants and charitable foundations are not conflicts of interest — though some say taking government money along with industry should be.

6) Paying Customers Only. 20 million citations of medical literature appear on the US National Library of Medicine web site. Many have author’s institutions and email. But do the abstracts show COIs? Not unless you’re a paid subscriber. Password please.

7) Paying Customers Only…Even When You Are Reading A Hard Copy. In hard copies of the August 5 New England Journal of Medicine, the disclosures of authors of “Suicide-Related Events in Patients Treated with Antiepileptic Drugs” are absent and said to be found with the “full text” of the article at NEJM.org.

When we asked Karen Pedersen Buckley, NEJM manager of media relations, why  disclosure information about doctors who challenge an 2008 FDA warning* were not available in the journal’s hard copy, she said the web site was being redesigned. “We hope that many of our readers will have access to the full text and disclosure forms through an institutional subscription at their hospital, university or library,” she added.

And for those who don’t? Trust us.

*FDA warned about seizure drugs’ suicide side effects. The authors largely find the drugs safe.

http://www.foodconsumer.org/newsite/Non-food/Healthcare/seven_ways_medical_conflicts_of_interest_are_disguised_111110061.html

See also CCHR’s expose, Shrinks For Sale: The Corrupt Alliance of the Psychiatric Pharmaceutical Industry

Joseph Biederman

Pharma Poster Boy, Psychiatrist Joseph Biederman http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/

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Drug-firm executives under new scrutiny in Medicare fraud

Tuesday, November 9th, 2010

The Washington Post, November 9, 2010

By Anna Edney

Federal inspectors want to prevent drug-company executives from doing business with the U.S. government when their companies are convicted of Medicare fraud.

Under guidelines from the Department of Health and Human Services’ Office of Inspector General, executives can be barred from contracting with federal health programs when they knew, or if the inspector general concludes they should have known, about fraud at their firms. The guidelines were posted Oct. 20 on the office’s Web site.

Authorities have been spurred by large settlements, said Robert DeConti, chief of the administrative and civil remedies branch in the inspector general’s Office of Counsel.

GlaxoSmithKline was ordered to pay $750 million on Oct. 26 for sale of defective drugs, and Pfizer agreed to pay $2.3 billion in September 2009 for fraudulent marketing of medicine. A company that employs someone barred from doing business with the government cannot receive federal payments.

That is definitely a renewed emphasis, maybe a new emphasis, on holding individuals accountable,” DeConti said in an interview last month.

Certain crimes, such as patient abuse or a felony conviction of health-care fraud, require automatic exclusion by law, according to the inspector general’s Web site.

The inspector general has the discretion to bar a person in other cases, such as a misdemeanor conviction.

Company executives might also be sanctioned if their employers are convicted of misconduct or they may be blocked from doing business with federal agencies. The inspector general has used this option 31 times since 1996. Most cases involved smaller, closely held companies such as those that make durable medical equipment, DeConti said. Twenty-eight people have been barred, he said.

Federal inspectors are targeting “complex cases that might involve global pharmaceutical manufacturers that are settling larger cases,” he said. “We have cases under development right now against individuals in that kind of company.”

In 2008, the inspector general barred three executives at Purdue Pharma. The officials at the drugmaker, based in Stamford, Conn., pleaded guilty to a misdemeanor for misbranding the painkiller OxyContin.

They were excluded from doing business with the government for 15 years. Purdue paid $634 million to settle criminal and civil claims that it misled patients and doctors about the addictiveness of OxyContin.

“An exclusion for 15 years is basically a career-ender,” said Cory Andrews, senior litigation counsel at the Washington Legal Foundation, who has criticized the Food and Drug Administration for what he calls excessive enforcement.

Pfizer has “invested substantial resources” to create a compliance program under which every employee gets mandatory training, said Christopher Loder, a spokesman for the New York-based drugmaker. He declined to comment on whether Pfizer executives might be targeted with exclusion.

Mary Anne Rhyne, a spokeswoman for London-based Glaxo, also declined to comment.

Tens of thousands of people and companies are excluded, including nurses, physicians, dentists, pharmacies and durable medical equipment suppliers.

“The current administration is feeling that they want to increase enforcement in this area, and they’re of the belief that monetary settlements aren’t sufficient, and they need to charge individuals to deter the conduct,” Jeffrey Senger, a lawyer at Sidley Austin LLP in Washington and former acting chief counsel with the FDA, said in a telephone interview.

Read the rest of the article here: http://www.washingtonpost.com/wp-dyn/content/article/2010/11/08/AR2010110805757.html

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Big Pharma executives facing legal threat; including potential fines and prison time

Sunday, October 31st, 2010

The Philadelphia Inquirer, October 31, 2010

by Christopher K. Hepp

Rats that infested a Philadelphia warehouse 40 years ago have found their way into the legal nightmares of the nation’s drug companies.Frustrated that even billion-dollar fines seem to have little effect on pharmaceutical firms, the Food and Drug Administration has increasingly signaled its intent to use a legal doctrine spawned by those long-gone rodents to bring criminal charges against top executives, even those who might have been unaware of company misdeeds.

Earlier this month, Eric Blumberg, FDA litigation chief, told an industry audience that his agency was looking for cases to use what is known as the Park Doctrine as a tool to “change the corporate culture” of firms that have thus far shrugged off other penalties.

In one area the FDA is targeting are companies that have illegally promoted products for unapproved uses, a practice know as off-label marketing.

“I don’t know when, where, or how many cases will be brought,” Blumberg told a gathering of the Food and Drug Law Institute, “but if you are a corporate executive – or counsel advising such a client – I would not wait for the first case to decide now is the time to comply with the law. They won’t get a mulligan on their conduct.”

In an interview Thursday, Blumberg was pointed.

“They need to take this seriously and find out what is going on in the marketing and sales divisions of their companies,” he said of pharmaceutical executives. “In my view, one thing that will get executives’ attention is a few cases in which we have convicted two-legged defendants.”

He singled out firms, including Pfizer Inc. and Eli Lilly & Co., that have paid multiple penalties in recent years.

Eli Lilly, for instance, was hit with a $1.4 billion fine last year for illegally marketing Zyprexa, a antipsychotic drug. The same year, Pfizer was fined $2.3 billion for illegally marketing the pain reliever Bextra. Neither company’s stock price suffered significantly, leading some to conclude that even massive fines are viewed by investors and executives as simply the cost of doing business. Neither firm responded to calls for comment.

“It is clear that fines are not working here,” Blumberg said. “We need to put something else on the scale to make people think twice, three times, before they promote drugs for unapproved uses.”

That something is the threat of prison and industry debarment, which could result from a successful prosecution using the Park Doctrine.

Under the Park Doctrine, a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing.

It stems from a case involving John Park, president of Acme Markets Inc. in 1970, when the company was cited for rodent infestations at a warehouse here.

The FDA charged Park personally with violating sanitation laws after other rodent infestations were discovered despite a number of agency warnings.

Park argued that as company president he was too far removed from warehouse supervision to be held responsible.

The U.S. Supreme Court ultimately agreed with the FDA that Park, as president, was responsible for ensuring rodent-free warehouses.

Park got off relatively easy: a $250 fine.

Prosecutors now hope to extract stiffer penalties under the doctrine, including up to a year in prison and $100,000 fines.

Those are the possible punishments facing four executives of Synthes Inc., a West Chester firm that pleaded guilty early this month in connection with illegal clinical trials of a bone cement. Charged under the Park Doctrine by the U.S. Attorney’s Office in Philadelphia, the executives have also pleaded guilty.

The Park Doctrine can be “a very powerful tool,” said Assistant U.S. Attorney John Pease, who supervises criminal prosecutions involving pharmaceutical-industry fraud cases in eastern Pennsylvania. But it also presents prosecutors with a number of hurdles, he said.

The crimes under scrutiny have a five-year statute of limitations, for instance. Often, prosecutors are not even alerted to them for several years, he said.

“And with multinational pharmaceutical companies with billions in revenue, you find responsibility is very diffuse,” Pease said. “The real challenge is finding a person who was in a position to know about and prevent the conduct that occurred.”

Scott Gottlieb, a former FDA commissioner who is now a partner with Arcoda Capital in New York, said another challenge would be assuring that an off-label case would hold up in court, particularly if it involved executives several layers above the departments that committed the illegal acts.

“There are clearly cases where the management is so far removed from the activity, they have no direct knowledge of the issue,” he said. “To hold them criminally liable is a significant policy step that needs to be done with great care.”

He agreed, however, that bringing criminal charges against executives “would be a significant deterrent.”

read the rest of the article: http://www.philly.com/inquirer/business/20101031_Big_Pharma_executives_facing_legal_threat.html?viewAll=y

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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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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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Public ‘misled’ by drug trial claims

Wednesday, October 13th, 2010


Tablets
BBC NEWS
October 13, 2010
by Michelle Roberts

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.

Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings.

The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.

Pfizer maintains its drug is effective.    Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK.

But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.  This is not the first time a large drug company

has come under fire about its published drug trial data.

Trial information

Pharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.

GSK rejected claims that it improperly withheld drug trial information.

But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.

Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer’s antidepressant reboxetine that should be made public because it could change views about the drug.

Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.

They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.

Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.

Biased picture

The researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.

“Our findings underline the urgent need for mandatory publication of trial data,” they say in the BMJ.

They warn that the lack of all information means policy makers are unable to make informed decisions.

Read the rest of this article here:  http://www.bbc.co.uk/news/health-11521873

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Booming Sales of Antipsychotic Drugs Often Fueled by Illegal Marketing Tactics

Wednesday, October 6th, 2010

FairWarning, October 6, 2010

By Jessica Roberts 

Antipsychotic drugs, once used to treat only the most serious mental illnesses, have emerged as the top-selling class of pharmaceuticals in the U.S., generating annual revenue of about $14.6 billion. Yet much of the sales boom has been achieved with illegal or controversial marketing tactics by major pharmaceutical companies to promote uses of the drugs that have not been approved by the U.S. Food and Drug Administration.

The result, according to an account by The New York Times, is that every major manufacturer of antipsychotic drugs — Bristol-Myers Squibb, Eli Lilly, Pfizer, AstraZeneca and Johnson & Johnson  — has recently settled criminal or civil government cases for hundreds of millions of dollars or is under investigation by the Department of Justice for possible health care fraud. The criminal fines paid by Eli Lilly and Pfizer last year set records last year for the largest criminal fines ever imposed on corporations, although in the case of Pfizer, the case was built only partly on the marketing of an antipsychotic drug.

In their defense, the companies say that they follow tight business ethics guidelines and that all possible side effects of their medicines are fully disclosed. Recently, however, the government has warned that some of the drugs may be fatal for older patients and have unknown effects on children. And critics question how drugs approved by the agency for use by 1 percent of the population, to treat illnesses such as schizophrenia and bipolar mania, could have turned into top sellers, prescribed for everyone from preschoolers to octogenarians.

At least part of the answer lies in the companies’ marketing tactics. The Times reports that civil and criminal lawsuits against big pharmaceutical companies have revealed hundreds of documents showing that some company officials knew they were using questionable tactics when they marketed these powerful, expensive drugs.

According to analysts and court documents, these tactics have included payments, gifts, meals and trips for doctors, biased studies, and ghostwritten medical journal articles. These all are meant, federal investigators say, to promote the benefits and downplay the risks of the drugs, while encouraging off-label uses — that is, uses the FDA has not approved but which doctors, if they choose, can pursue with their patients anyway.

Drug companies skirt restrictions on promoting off-label uses by hiring consultants, researchers and educators to handle the job, delivering the marketing message verbally and through company-sponsored studies. “They can give a small hint, and people will take the bait,” Dr. Robert Rosenheck, a professor of psychiatry and public health at the Yale School of Medicine, told the Times. “Psychiatric disorders are vaguely defined enough that you can stretch definitions.”

The Justice Department claims drug companies trained sales representatives to rebut valid medical concerns about unproved uses of antipsychotic drugs. For example, the department says, Eli Lilly produced a video called “The Myth of Diabetes” to sell Zyprexa, which became its all-time best-selling drug, even though evidence showed that Zyprexa could cause diabetes.

Read the rest of this article here: http://www.fairwarning.org/2010/10/booming-sales-of-antipsychotic-drugs-often-fueled-by-illegal-marketing-tactics/

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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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Sex, Lies and Pharmaceuticals—How Female Sexual Dysfunction (a “mental disorder”) was invented by the drug industry

Friday, October 1st, 2010

The Independent
By Jeremy Laurance
October 1, 2010

Female sexual dysfunction – which is claimed to affect up to two thirds of women – is a disorder invented by the pharmaceutical industry to build global markets for drugs to treat it, it is claimed today.

Drug companies have invested millions in the search for a female equivalent of Viagra, so far without success. But while doing so they have stoked demand by creating a buzz around the disorder they have created, according to Ray Moynihan, a lecturer at the University of Newcastle in Australia.

Corporate employees worked with medical opinion leaders, ran surveys aimed at portraying the problem as widespread and helped create the diagnostic instruments to persuade women that their sexual difficulties deserved a medical label. But sex problems in women are far more complex than they are in men, encompassing lack of desire, lack of arousal and lack of orgasm and the drug industry’s narrow focus is failing them.

Mr Moynihan, who first investigated the drug industry’s role in female sexual dysfunction a decade ago, says it illustrates a wider problem about the creation of new diseases, and the widening of existing boundaries for treatment with designations such as pre-diabetes, pre-hypertension and pre-osteoporosis, for which the latest treatments are aggressively promoted.

In his new book, Sex, Lies and Pharmaceuticals, which is previewed in the British Medical Journal, he says: “Drug marketing is merging with medical science in a fascinating and frightening way. Perhaps it is time to reassess the way in which the medical establishment defines common conditions and recommends how to treat them.”

In 2005, Pfizer, makers of Viagra, funded a survey which showed 63 per cent of women had sexual dysfunction and that testosterone and Viagra might be helpful. In 2006, Procter and Gamble, makers of a testosterone patch for women, sponsored a survey showing one in 10 postmenopausal women had hypoactive [low] sexual desire disorder (the company sold its drug business in 2009). In 2008, Boehringer Ingelheim, makers of flibanserin which is claimed to boost the female libido, sponsored a survey which also showed one in 10 women was in need of help.

Efforts by the companies to meet the need have subsequently foundered. Pfizer pulled Viagra from the market for women after trials showed it had no greater effect than placebo. Procter and Gamble’s testosterone patch was rejected in 2004 in the US, over fears it raised the risk of cancer and heart disease and Beohringer Ingelheim’s drug, flibanserin, was rejected by the US Food and Drug Administration in June on the grounds it had failed to deliver the agreed benefits while carrying the risk of serious side effects.

Mr Moynihan warns that although the drugs have so far failed, more are in the pipeline and claims that “the drug industry shows no signs of abandoning plans to meet the unmet need it has helped to manufacture”. A spokesman for Pfizer said: “We currently have no plans to develop medicines for FSD.”

Read entire article here:  http://www.independent.co.uk/life-style/health-and-families/health-news/female-sexual-dysfunction-was-invented-by-drugs-industry-2094578.html

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