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Lawsuits Say Pharma Illegally Paid Doctors to Push Their Drugs

Pharma companies are being accused in lawsuits of paying doctors to push off-label uses of their drugs or financially rewarding doctors for prescribing their brand-name medications.

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Drug companies say the millions of dollars they pay physicians for speaking and consulting justly compensates them for the laudable work of educating their colleagues.

But a series of lawsuits brought by former employees of those companies allege the money often was used for illegal purposes — financially rewarding doctors for prescribing their brand-name medications.

In several instances, the ex-employees say, the physicians were told to push “off-label” uses of the drugs — those not approved by the U.S. regulators — a marketing tactic banned by federal law.

In the past three years alone, pharmaceutical companies have anteed up nearly $7 billion for settlements in cases such as one filed by Angela Maher, a former drug sales rep for Ortho-McNeil Pharmaceutical.

Maher sued the company in Massachusetts federal court in 2003, alleging it pushed an anti-seizure drug for 27 off-label uses. She said company officials rigorously tracked whether their payments to physicians were worthwhile.

Maher said she would regularly hear commentary from her boss after a physician spoke at a dinner program: “‘After he talked last week, our sales went up 8 percent’ or ‘I listened to doc ABC and he barely mentioned’” the drug.

The company settled for $81 million earlier this year and pleaded guilty to a misdemeanor charge of misbranding a drug; Maher was awarded $3 million.

Allegations in other whistleblower lawsuits provide a rare glimpse into the inner workings of the drug marketers:

-- Allergan, the maker of Botox, created faux advisory boards solely “to reward hundreds of its top injectors,” federal prosecutors charged this month. More than 200 doctors, for example, were put up at an oceanfront resort in Newport Beach, Calif., in 2005 and 2006 and paid $1,500 to listen to presentations, according to their sentencing memorandum.

Allergan settled with the government for $600 million last month and pleaded guilty to a misdemeanor for misbranding Botox. Allergan said in a statement that it is “committed to conducting its business with the highest ethical standards and in compliance with all applicable laws.”

-- Forest Laboratories created “preceptorship” programs in which physicians were paid up to $1,000 each to allow a sales rep to spend time observing their practice. “In reality, Forest sales representatives used the preceptorships to induce physicians to prescribe [anti-depressants] Celexa and Lexapro,” according to a 2009 complaint filed by federal attorneys in Massachusetts.

The reps filled out “return on investment” forms to justify the payments from 1999 until 2003. One rep noted that a psychiatrist’s prescription “numbers were trending up,” and “we need to keep a good thing going as long as we are still getting this kind of growth,” the complaint said.

A Forest subsidiary pleaded guilty to one felony and two misdemeanors and the company paid $313 million in criminal and civil fines. In a statement, Forest’s CEO said the firm had improved its “compliance program since the events at issue in this investigation, which occurred a number of years ago.”

-- In a 2005 lawsuit pending in Pennsylvania , Wyeth Pharmaceuticals is accused of hiring speakers until 2003 based on how often they prescribed the kidney transplant rejection drug Rapamune. “Wyeth management was able to exclude speakers who did not promote Rapamune, and reward those who did so with repeated speaking engagements and resulting honoraria,” according to an amended complaint filed this year by two former sales reps.

Speakers who were “unfavorable or even unenthusiastic” about Rapamune were counseled by drug reps on the “ways in which the speaker might treat Rapamune more favorably,” the complaint said.

The federal government has taken over the lawsuit, which is pending in federal court in Pennsylvania. Pfizer, which owns Wyeth, said in a statement last month that the company is “committed to ensuring that information provided to physicians on the uses, benefits and risks for Rapamune is consistent with its FDA-approved label.”

Last year, Pfizer paid $2.3 billion to settle allegations in other cases that it had illegally promoted its drugs.

-- Cephalon was accused of rewarding even poor speakers if they heavily prescribed its narcotic lollipop Actiq and other drugs, according an amended complaint filed in 2008 by a former sales manager. Physicians were paid to attend speaker training even though the company never intended them to speak. Some were paid even when no one showed up to hear them, said the complaint filed in federal court In Pennsylvania.

“Even good public speakers have been dropped by Cephalon,” the lawsuit said, “if experience later showed that they did not themselves write substantial off-label prescriptions.”

Cephalon pleaded guilty in 2008 to a misdemeanor count of selling misbranded drugs and paid $425 million in penalties. In a statement, an official said the company had put a “strong compliance infrastructure” in place that has “improved the accountability of our employees and the transparency of our actions.”

One company continued to pay doctors to discuss its products even after it settled a lawsuit that singled out those speakers for alleged misconduct.

The case, filed against AstraZeneca, detailed how California psychiatrist Rimal Bera discussed the antipsychotic Seroquel for “conduct disorders” in children even though it was not approved for that use.

AstraZeneca settled with the government for $520 million in April, and like the other firms, signed a corporate integrity agreement promising to follow federal rules.

AstraZeneca paid Bera at least $10,530 for speaking this year, company data show. It paid another doctor named in the case nearly $42,000. A company official would not discuss Bera but said speakers are terminated if they violate company standards. In an interview, Bera said he has become more conscious of when it is permissible to discuss off-label uses.

“We have done a better job certainly as speakers — and I think the industry really has hammered this home,” he said.

Illegal marketing of drugs for off-label use is rampant. I’ve done a lot of research into this area and have written a novel published this year by Random House that explores some of these issues. You can read about STASH at http://www.bydavidklein.com.

Compensation is not always paid in the form of cash / checks. For example, there’s a group of MDs in my town that have a big pharma paid gourmet buffet lunch delivered every week (this is fact, as one of the nurses invited me & told who pays for it) costing about $500.00 (its a group of 5 MDs + staff, totaling 10 or more people). Then there’s the all expense paid vacation vouchers (basically gift coupons) to places like the Caribbean, Hawaii, etc. that has not been counted in this list.

actually, all things that are given to healthcare providers, fees, lunch, vacation vouchers (?) are accounted for and reported in these pharma records.

And, off-label promotion is a completely seperate story.  The fees discussed in this article are generally for consulting and promotional talks on behalf of the company.  The materials that are produced for promotional talks are all on-label and are submitted to the FDA for reivew.

Just curious as to the qualiifications and/or conflicts of interest of the authors that leads to such a biased and unbalanced report. Providing medical speakers, with relevant experience, to speak to their peers about their experience is a well-accepted mechanism by the FDA. This is not the case for other bodies like OIG and

I also realize that “whistleblower” (WB) is a status akin to sainthood in this climate, but realistically the charged offenses and the smoking guns are just so much hearsay fueled by the disappearance of the rep’s jobs.

WB’s are closer to the mob hit men who told all for witness protection than saints. The profit motive for the WB’s colors everything that is put forth by them and should be judged as harshlly as we judge the companies.

The rapid settlement by the drug companies is evidence of expediency than abject “gulit”.

I expect much more from “balanced” media.

I was an unknowing “victim” of the Allergan/Botox scam this year when doctors at UCSF Surgical Movement Disorders Dept. consulted with me on my request to try Botox injections for head tremor associated with my longstanding diagnosis of essential tremor.

I was not warned of possible serious side-effects, including death. Nor was I given the FDA required Botox literature with a Black Box Warning.

Dr. Nicholas Galifianakis and Dr. Jennifer Landes then submitted a claim to Medicare and Tricare with a sham diagnosis of cervical and vocal dystonia, rather than my correct diagnosis, in order to defraud my insurers into paying for the treatment.

It is nearly six months since my Botox injections and I still suffer from the after effects of this treatment. Meanwhile the doctors at UCSF Surgical Movement Disorders Dept. continue to treat patients and make money for themselves and Allergan.

Thank you for your expose.

I am a physician and have done promotional speaking for medications that I use and think are useful. The conduct, speech and slides during these talks are all very tightly FDA regulated. Off label promotion is strictly forbidden now and has been for years, though it was not as emphasized in past years. The companies are now going to extremes to emphasize this. Even the answers from me to unsolicited questions from MD’s that are on off label uses are tightly controlled and regulated. Numerous warnings on side effects need to be reviewed to be in compliance. Lunches in my office from drug reps are sandwhiches or pizza or equivalent- there are no ‘goumet lunches’- because that is how they get the doctors attention for a few minutes. Going to a speaker update is paid, but it should be - in exchange one usually loses time in the office in order to travel and for attendence, which may cost more revenue from lost office time than one is paid. There is no travel to some exotic location. You travel to the location the day before, then one sits through 6-8 hours of lectures, then you head back to the airport and leave. The speaker presentations take time to prepare for, time for travel, and to present and answer questions afterwards. I find primary doctors find them useful, because the welcome peer to peer learning.
The entire tone of the story is negative and one sided. One can always find worse case examples. I would expect a more balanced report from NPR.

I find it interesting that some Docs believe that they should receive compensation for the time they spend in Rx update seminars.  In all other industries professionals usually have to pay for training and continued education about best practices.  In fact, I can think of no other industry where people are paid to “listen” to a speaker. This just emphasizes how out of touch the health care industry is compared to the rest of the true free market.

D McElroy should realize that the previous comment was in regards to speaker training sessions, not educational activities. As a speaker you are an independent contractor and have every right to be reimbursed for your time and lost income in “the true free market”.

In response to S. Algeo - I have no problem with the speaker being paid.  I have a problem with the audience being paid for filling out some limited questionnarie or other frivilous survey in order to disguise a payment as some justified research cost by the pharma companies. I was lucky enough to be a guest at one such function.  As far as a free market, the day I see hip replacement price wars advertised on banners outside of Surgical clinics and drug margins around 40% like other highly competitive markets is the day I’ll believe a market has been established. Until then, I will continue to see the raises that I could pay directly to my employees instead be applied to their ever increasing health care premiums

This is a powerful site that has emerged in the wake of exposing the practices of pharmaceutical corporations and universities.

I would like to see a focus on pediatric medication, mainly the “illegal and wrongful” marketing of psychotropic drugs to children, as charged by the DOJ.

These drug companies not only push FDA unapproved psychiatric drugs to child in foster care and SCHIP, but also ghostwrite and lobby to manipulate the federal Medicaid program to fund their illegal activities.

Anything dealing with child welfare is sequestered from public scrutiny; therefore, I present this task to ProPublica:

Expose the Medicaid fraud in child welfare.

Beverly Tran

I am surprised an expose was not done on the whistleblower- $3M! -talk about unethical and disgusting! As far as the Pharma issues, the talks are very regulated, there are no free vacations or any such nonsense and there is nothing illegal about this. Why is this even a story?

The drug companies not only pay doctors, but they hire hundreds of lobbyists to influence regulators and legislators in Washington. They also spend millions of dollars advertising in magazines and on TV, effectively influencing the content of those media. Medicine was once a lofty profession, earning its stature through the Hippocratic Oath and groundbreaking research. These days, it’s succumbing to the pressure of money and power.

Arnold Klein, M.D.
Professor of Medicine & Dermatology, Geffen School of Medicine, UCLA
Consultant, FDA

arnold kleinmd

Oct. 22, 2010, 1:37 a.m.

As the individual who pioneered the FDA approved cosmetic use of Botox as well as the use of dermal fillers,I feel one would be wise not to cut corners on his or her choice of cosmetic surgery centers. On nearly every street
corner, treatment centers have popped-up with the creation of med spas, typically staffed by nurses. The public has been reassured that these are simple ‘in-and-out’ procedures easily performed by anyone. The problem is these are not simple treatments. They require a great deal of scientific understanding and finesse. These procedures should not be performed at the mall or in the back room of a beauty parlor by untrained individuals. Education in this field is not a weekend course given by the manufacturer.
As many of the country’s largest pharmaceutical companies
continue to teach anyone who can hold a needle how to inject Botox, a potentially toxic substance, the number of serious reactions are increasing dramatically. Profit has replaced patient safety as the major theme of Continuing Medical Education is controlled by drug companies
setting the stage for potential medical disasters. Compounding this is the forged medical literature, illicit promotion of products to American physicians by unlicensed foreign physicians, and the rampant approval of potentially disfiguring injectable agents by the Food and Drug Administration. Furthermore through rewards of $10,000 a day the drug companies control the officers of medical societies who control the speakers at medical meetings as well as the articles in medical journals.Furthermore, a company such as Allergan employs up to 15 lobbyists. As the individual considered responsible for getting the black box warning on Botox
I remain appalled by the FDA’s approval of substances such as injectable Plexiglas (Artefill), suture material (Sculptra), and injectable bone (Radiesse). These compounds
have severely scarred and impaired the health of people around the world, and as a result, are no longer used in most countries. What’s even more shocking is the discovery that articles written about agents such as Botox are totally incorrect and rely on falsified data.The FDA has over 180 reports of life-threatening adverse reactions to Botox with 80 requiring hospitalization. Until recently, the effects of all injectable filling agents were temporary and
very rarely associated with permanent problems. In the past, the permanent injectable silicone had been used but had been so problematic that the Justice Department filed injunctions against certain physicians on behalf of the FDA.  This doesn’t happen any more. Politics and money have changed the face of aesthetics in America.
Arnold KleinMD part 2

First, Angela Maher was so concerned that she sued and was awarded $ 3 million from Ortho-McNeil Pharmaceutical. I wonder where she thinks that money will come from and I wonder what she will do with the money? Certainly she will donate ALL of it to worthy causes.
Second, how do you spell “hypocrite?”

The $3 million award is what is known as a bounty, whose origins goes back to the Magna Carta. 

The statutory provisions created financial incentives for citizens to step up and report their personal knowledge of fraud, waste and abuse during President Lincoln’s administration.

The government cannot be everywhere at all times.  This is civic engagement for the whistleblower.

It’s called the False Claims Act and needs more enhancements to become an even more effective tool for citizens to report these activities which are harmful to everyone.

Whistleblowers should be honored and compensated for the work they have done and harms they have endured.

It think there would be a fine line between “bounty” and “extortion,” and I would be curious to know if she filed this case while she was still working for the company OR if she filed the case as a disgruntled employee. Hero or Vengeance? Three million dollars is more than most people would expect to earn in their entire career.

For the record, I’m NOT taking up for the pharmaceutical industry and providers that prostitute themselves.

I suggest, Mr. Fox, if you have challenges with the competency of the court discerning between “bounty” (proper legalese) and “extortion” (criminal charge) then perhaps you should write a letter to the presiding judge of the case, submit amicus curiae on behalf of the pharmaceutical corporation and lobby U.S. Congress to rescind the False Claims Act, 31 U.S.C. § 3729–3733.

Waking up in Ameica

Oct. 23, 2010, 3:21 p.m.

My concern and worry about the drug, snake oil pushers, pushing the latest and greatest toxic medicines and vaccines, are the potential DANGERS it might have on our infants, babies, toddlers, children, adults and elderly who are BEING subjected OR FORCED into compliance. 

I do not trust the pharmaceutical companies nor our government when it comes to ANYTHING!

Why are there MORE immunizations TODAY, GIVEN EARLIER and more combined immunizations given today than in the past?

WHAT EFFECT DOES THIS HAVE ON INFANTS AND BABIES WHO’S IMMUNE SYSTEM HAVE NOT DEVELOPED?? 

WHY ARE WE GIVING OUR BABIES MORE AND MORE IMMUNIZATIONS and why are THEY BEING given in more and more COMBINATION’S ??

Government’s coziness with the drug companies,  is VERY CONCERNING!

The masses who reject this mass immunization, are then FORCED INTO IT whether one agrees to it or not!

The combining of flu vaccines with the H1N1, the combining of pertussis with tetanus, and on and on….....

Where is the research that PROVES THE NECESSITY AND SAFETY OF IT ALL??

Richard Beasley

Oct. 24, 2010, 5:30 p.m.

So-long as we have peer reviewed medical articles written for the express purpose of “experimenting” with drugs in off-label environments, so will we have a medical community willing to participate. Big Pharma experimentations with off-label uses of their drugs is quote “illegal” while producing hundreds of peer reviewed documents published in medical publications showing and telling doctors how to conduct such experiments is legal.  Seems we have a system by which the doctors are in fact providing Big Pharma with advanced “free” research within the innocent patient population.  Trial and error research that can yield a new indication for their drug which effectively bypasses a couple $100-million more in running the clinical trials on the same.  I found this especially true in the drug Aldara mfg. by 3M Pharma.  This whole story is released on http://www.aldara1.com

Fascinating Blog-itry. This really demonstarets the lack of understanding that we live in a capitalist economy that has rewards for actions and business risks. All parties involved are acting in their own seld-interest, guided by their profit motives and self-sustainability. Note that the drug companies annd device companies promote according to the guidelines issued by the FDA & statutes from the states and Fed.. It needs to be noted that the guidance for the governing bodies are ambiguous and allow for substantial interpretation in execution. This is apparent by the lack of “damning” evidence submitted by the money-motivated whistleblowers.
Yes, Dorothy, the righteous WB’s are after money too! Bounty or extortion - semantics at best. Remember the poster child for the WB effect is the clown who went to Merck, hired to get their shop in order, documented with an attorney from day 1 & none months later turned WB. He pocketed $75 million! And it was “tax free” money at that. Oh you didn’t know that the WB portions are rendered tax free status - well now you do.
The cases where the evidence is clear and the wrongdoing is defined - people go to jail; they don’t just “consent” to do better in the future.
The OIG and state’s words for extortion are “penalties and fines”. Much of this industry attack and search for WB’s was spurred by the overuse of meds - especially off-label. Some of this was due to the companies and much was due to the MD’s profit motive, e.g., oncology and urology in particular.
We’ll see what the Obamacare-incentivied changes will bring besides confusion.

It is a laughable to read such prose on the vitues of the pharma companies and the medical profession, and their right to make money from the sick, and the gullible.

There is no disputing that the costs of the US medical system are huge, the highest per head in the world, and the benefits to the population less than in Western Europe and in Canada.

Of course if I were a doctor or a pharma executive I would be very pleased with the status quo, and vigorously defend my pork barrel.

As for whistleblowers, fining the company hurts the shareholders who have no power but the executives seem to escape scot-free. Perhaps clauses for recovery for illegal acts should be inserted in all execs contracts. And perhaps a ten year holdback on 10% of their salary whilst employed.

Shareholders should not be shafted.

Thanks to ProPublica for being one of few sources for authentic investigative journalism. When I had a herniated disc several years ago, I noticed that my doctor was writing me lots of prescriptions for Vicodin and other drugs, even when I told him that the drugs made me feel worse instead of better. Without apparent shame or fear, he calmly explained to me that he was in a “contest” with other doctors sponsored by the pharmaceutical company that manufactured the drugs he prescribed. If he prescribed the most, he won a trip to Hawaii for him and his wife. If he prescribed at least past a certain threshold, he got lesser but still lucrative rewards. I reported him to the medical board and the hospital where he worked and was told that this is business as usual. I then researched the medical-industrial-pharma cabal and realized it’s all about profits and perks. I walked away from allopathic (regular) doctors and took control of my own health via an organic diet, serious exercise, yoga, tai chi, and acupuncture. I am healthier than anyone my age or younger that I know. I hope to never see the inside of a regular doctor’s office again, nor will I take prescription pharma or over the counter meds unless there’s absolutely no alternative. Thanks again ProPublica for busting these greedy medical malpracticioners and the corporations who own them!

Using the concepts of “free enterprise” and “capitalism” to rationalize the conduct of pharma companies and certain doctors does a disservice to reputable industries and professions that do not give or receive payoffs in order to do business.

The practices cited in this article have been in effect for decades. Years ago doctors I personally know bragged about taking the largesse of the pharma companies. They recognized that they were merely cashing in on freebies. Many stated that they regretted they didn’t have the time to take advantage of the free trips and had to be content with the local dinners out and theater. They loved getting $1000 a pop to attend nothing more than a sales pitch for a particular drug, their offices being fed lunches at least three times a week, and even using vouchers so they could order take-out at home. Some of them were more sophisticated than others and cashed in royally. Others obviously were nothing more than cheap dates.

Many doctors over the years lost both their dignity and their pride when they saw others being lavished upon. Others spread the gospel and encouraged their colleagues to get on the band-wagon.

Marketing and sales efforts do not need to plumb the depths like pharma has. The best hope we have is that “new” doctors with somewhat more realistic expectations and a more elevated set of goals and motivations will break the cycle.

hank colorado

Nov. 1, 2010, 11:51 p.m.

I noticed that some of the writers here were talking about bias and calling for a more fair and balanced report. We are talking about literally billions of dollars in awarded settlements, fines and judgements…from the destructive side of drugs pushed by these billion dollar plus pharmaceutical corporations…and barely noticeable peeps out of the mainstream media. So much for fair and balanced. From the media we get shootings, weather calamities, and Lindsey’s never ending rehab. But we do get commercial after commercial brainwashing us into believing that there’s a pharmaceutical fix for everything. Big Pharma’s fear tactics selling high cholesterol,low bone density, diabetes,etc. drugs while they are being sued in class actions for these same drugs should be a crime. We know cigarettes can kill…you don’t see those ads on TV. It’s just Big Pharma maximizing it’s profits before the drugs are banned forever like they are already in more progressive countries. Don’t expect fair and balanced from big media that makes 10’s of millions of dollars from Big Pharma…just expect a little truth from people speaking freely and for free here on this blog.

If off-label prescribing is such a big deal, why not make it against the law and haul the doctors themselves off to jail?  Just being facetious, but the fact is that people love to bash pharma but they ignore the fact that they have access to drugs that dramatically extend their lives and improve their well being. The system continually corrects and improves itself. For example a few years ago, the pharma industry on its own volition eliminated the once familiar logo-festooned pens and other premiums.

Richard Beasley

Nov. 17, 2010, 6:41 p.m.

I don’t think for a minute anyone on here would suggest that we should ban the anti-biotic drugs as there would surly be mass numbers of deaths occur within months.  However, with that said there are drugs on the market that are there because of who their manufacturers happen to be in the scheme of things, not because their respective drugs are ligitimate in safety and efficacy.  i.e., Forget for a minute if it would be safe to do this just follow along and stay with me on this.

You give your patient the following cocktail of cytokines by way of I.V., continueously for over 21-days, and 24/7.

INF-a / g,  TNF-a,  IL-1,  IL-1Ra,  IL-6,  IL-8,  IL-10,  IL-12 p40,
G-CSF,  GM-CSF,  1-a(MIP-1),  MIP-1b,  and MCP-1

Hypothetical Protocol:
  All of these products are made available to the patient through means of I.V.
The length of the exposure is 21-days (min), 24/7 without interruption.
The levels for each are below the lethal levels for each but higher than innate levels for each.

What would you expect the outcome to be in relation to autoimmunity, GI Conditions, Brain Damage, Neurological damage,  and other permanent conditions you may think of, instantaneously? 

My very next post will demonstrate where I am going.

Richard Beasley

Nov. 17, 2010, 7:03 p.m.

I am quite sure you have arrived at some variance of the same conclusions on this.  It would be so dangerous you probably would think this could never be an FDA approved tool or prescription drug being prescribed to patients ON-LABEL, right? 

The drug of which these 14-cytokines which represent the pharmacological drug mechanism of action is the 3M Pharmaceutical drug , Aldara/imiquimod.

The hypothetical protocol I listed above is actually the standard protocol being used everyday in practices.  Many users are permanently and seriously disabled by their use of this drug while the FDA continues to approve more generic formulations, 3 more this year.  Yet, as the victims pile up in numbers, FDA is giving it gas to approve more harmful variations of the drug.  This is what needs to be fixed in Health Care, punishing the frauds taking place by taking their ill-gotten drugs off the market rather than fining them and seemlessly passing it on to be reimbursed by the public.  For more on this subject visit   http://www.aldara1.com

This article is part of an ongoing investigation:
Dollars for Doctors

Dollars for Doctors: How Industry Money Reaches Physicians

ProPublica is tracking the financial ties between doctors and medical companies.

The Story So Far

ProPublica is investigating the financial ties between the medical community and the drug and device industry. In October 2010, ProPublica compiled the list of payments that drug companies make to physicians and built a publicly searchable database so that patients could look up their doctors.

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