Pharma sales rep paid physicians to participate in hundreds of sham “speaker programs” in order to prescribe med drugs

Subsys : Drug Company Sales Rep Sentenced for Role in Kickback Scheme Related to Fentanyl Spray Prescriptions

John H. Durham, United States Attorney for the District of Connecticut, announced that NATALIE LEVINE, 35, of Scottsdale, Arizona, was sentenced today by U.S. District Judge Janet Bond Arterton in New Haven to five years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. Judge Arterton also ordered Levine to spend the first six months of probation in home confinement, and to perform 150 hours of community service.

According to court documents and statements made in court, from approximately March 2013 to October 2014, Levine was employed by Insys Therapeutics, an Arizona-based pharmaceutical company that manufactured and sold Subsys, a fentanyl-based sublingual spray that was approved by the Food and Drug Administration solely for the management of breakthrough pain in cancer patients. Levine was a sales representative for the company and was responsible for covering the territories that included Connecticut, New Hampshire and Rhode Island.

Levine induced certain medical practitioners, including an advanced practice registered nurse (APRN) in Connecticut, a physician’s assistant (PA) in New Hampshire, and a physician in Rhode Island, to prescribe Subsys by paying them to participate in hundreds of sham “Speaker Programs.” The Speaker Programs, which were typically held at high-end restaurants, were ostensibly designed to gather licensed healthcare professionals who had the capacity to prescribe Subsys and educate them about the drug. In truth, the events were usually just a gathering of friends and co-workers, most of whom did not have the ability to prescribe Subsys, and no educational component took place. “Speakers” were paid a fee that ranged from $1,000 to several thousand dollars for attending these dinners. At times, the sign-in sheets for the Speaker Programs were forged so as to make it appear that the programs had an appropriate audience of healthcare professionals.

The medical practitioners were paid thousands of dollars in illegal kickbacks in order to prescribe Subsys, and induce others to prescribe Subsys, over similar medications. Medicare Part D plans authorized payment for hundreds of Subsys prescriptions written by the three medical practitioners, resulting in a loss of approximately $4.5 million.

Levine’s restitution figure will be determined after additional court proceedings.

On July 11, 2017, Levine pleaded guilty to one count of conspiracy to violate the anti-kickback law.

Several other individuals affiliated with Insys Therapeutics, and medical practitioners involved in this kickback scheme, have been charged and convicted in the District of Connecticut and in other Districts across the United States. In sentencing Levine, Judge Arterton credited Levine’s significant cooperation and assistance to the government’s prosecution of defendants in Connecticut, Massachusetts, New Hampshire and Rhode Island.

On January 3, 2019, Levine’s husband, Michael Babich, who was the CEO and President of Insys Therapeutics, pleaded guilty in the District of Massachusetts to conspiracy and fraud charges stemming from the scheme. He awaits sentencing.

On May 2, 2019, a federal jury in Boston found John N. Kapoor, the founder and former Executive Chairman of Insys Therapeutics, and four other former Insys executives guilty of racketeering conspiracy.

Earlier this month, Insys Therapeutics agreed to pay a total of $225 million to resolve criminal and civil investigations of the company.

The investigation in the District of Connecticut is being conducted by the U.S. Department of Health and Human Services Office of the Inspector General and the Federal Bureau of Investigation, with the assistance of the Drug Enforcement Administration’s Tactical Diversion Squad. The case is being prosecuted by Assistant U.S. Attorneys Douglas P. Morabito, Sarah P. Karwan and Richard M. Molot.

U.S. Attorney Durham encouraged individuals who suspect health care fraud to report it by calling the Health Care Fraud Task Force (203) 785-9270 or 1-800-HHS-TIPS.

Department of Justice
U.S. Attorney’s Office, District of Connecticut, News And Press Releases, Monday June 24, 2019

Doctors’ unconscious instinct to reciprocate med reps’ gifts

What Big Pharma knows about people’s hardwired instinct to return the favor when given a gift

Abstract

… “You might reasonably ask whether a modest meal with a pharmaceutical sales rep matters all that much. You might also be surprised by what a small gift can buy. In recent years, social psychologists and marketers have demonstrated that the pull of reciprocity is exceedingly powerful in human beings, often acting on us in ways we may not consciously appreciate. Perhaps it’s too much to suggest that free pens were responsible for the opioid epidemic. But it’s become more and more clear that a gift, even from a salesperson, can make the receiver feel obliged to give something in return.” …

Read Did Free Pens Cause the Opioid Crisis? on the atlantic, about the role of medical representatives in the promotion of pharmaceuticals in general, and the opioid crisis in particular.

Shady Deals between Device Makers and Hospitals … Damages are on Patients

Newstapa investigates collusion between device makers-hospitals in Korea

Doctors should be free to choose the best medical device when treating their patients. But if the doc is paid with $ and fancy trips by MD makers, will his/her decision be objective ?

Korea Center for Investigative Jounalism (KCIJ)-Newstapa has investigated the problems of medical device industry as part of the cross-border investigation project with the International Consortium of Investigative Journalists(ICIJ) and its 58 member news organizations from 36 countries.

Video published on 27 Nov 2018, by newstapa.

How Pharmaceutical Companies Entice Doctors into Prescribing Expensive Medication

An excerpt from Dissenting Diagnosis, by Arun Gadre and Abhay Shukla, published by Random House India

Written by the doctors and public health advocates Arun Gadre and Abhay Shukla, Dissenting Diagnosis is based on a study conducted at Support for Advocacy and Training to Health Initiatives, a Pune-based non-governmental organisation. During the course of this study, Gadre and Shukla interviewed 78 doctors from across the nation in an effort to confront what they consider is an ongoing crisis of the medical profession: doctors, they write in their introduction to the book, are finding “their traditions of ‘keep patients foremost’ rapidly buried under the ruthless logic of ‘keep profits foremost.’” Gadre and Shukla discussed with these medical professionals issues such as lack of regularisation in the private sector, unlawful and unethical practices routinely followed by doctors, the influence of pharmaceutical companies, the state of medical education, and the possibility of a universal healthcare system.

How Pharmaceutical Companies Entice Doctors into Prescribing Expensive Medication, caravanmagazine, 16 April 2016.

In the following excerpt from the book, interviewees speak to the writers about the hold of the pharmaceutical companies over the medicines prescribed by doctors. They describe how, through offers of gifts and benefits, aggressive marketing and sheer persistence, representatives from pharmaceutical companies routinely entice doctors into prescribing expensive and often unnecessary medicines to their patients. The pharmaceutical companies, one of the doctors said, are “like a pack of wolves.”

“Some of my doctor friends boast to me that they have travelled the world, sponsored by pharmaceutical companies. One was telling me with pride that even their shirts, pants, vests and underwear are given by pharmaceutical companies!” says an ophthalmologist from a medium-sized city.

Dr Suchitra, a general practitioner in Chennai, mentions, “The pharmaceutical companies offered to sponsor me for a conference, but I refused. I usually prescribe generic medicines or cheap, branded medicines. But the interesting thing is that once these pharmaceutical companies realized I don’t prescribe their medicines, they stopped visiting me.”

“I have been practising for thirty years. I have not given any ‘cuts,’” a super-specialist from a metropolis shares. “I did not encourage pharmaceutical companies. I change the medicines prescribed to my patients, prescribing cheaper medicines if expensive medicines have been prescribed. And what a big difference this makes to the patient! Sometimes the cost is reduced as much as Rs 35–40 per tablet! Patients are often unnecessarily prescribed expensive brands of medicines, for years on end, sometimes for life. The hapless patient keeps taking these medicines.

“Once, four medical representatives visited me with their bosses. They tried to convince me that I should not replace their brands, while prescribing cheaper brands to patients. We discussed the matter for an hour and their argument was that their company does a lot of research, on which they spend crores of rupees. That is why their brand is more expensive by Rs 30 per tablet.

“After they had finished their speech, I took Rs 1000 out of my pocket and handed it to one of the bosses. Surprised, he asked me what this was for. I answered: ‘You are doing such good work for humankind. This is my small contribution!’”

“After that I emphatically told them that I would help them, but how could I do this at the patients’ expense without telling the patients? Of course, they had no answer to that.”

A big-city surgeon remarks, “Pharmaceutical companies sponsor conferences where nobody bothers to listen to the lectures. Doctors just go to the stalls, and collect gifts. They enjoy the free drinks. It is a filthy business. What can one say?”

“Medical representatives influence the doctors. One of them offered me a trip to Singapore. I refused and told him that I would go at my own expense, and when I wanted,” said a general practitioner from a big city.

A super-specialist from a metropolitan city also shares, “The medical representatives are really persistent; they don’t leave you alone. Earlier, I would get angry at them. One of them pleaded with me, “Sir, you are the only one left. The other doctors, like you, who would earlier not take gifts, have all gradually succumbed. That’s why I am now meeting you too.” Since then, I don’t get angry with them.

“Recently, a medical representative brought along a diamond necklace as a gift, worth Rs 1 lakh.

“I asked him, ‘What’s this?’

“‘A diamond necklace, sir.’

“‘For whom?’

“‘It’s for your wife.’

“Controlling my temper, I asked him, ‘How do you dare to put a necklace on my wife’s neck?’

“The poor fellow was taken aback. ‘It is you . . . you will put the necklace on your wife’s neck.’

“Giving it back to him, I told him in a calm voice, ‘If that is so, then I will buy it with my own money. That is, if she wants a necklace at all!’

“The poor fellow left with the necklace.”

Dr Sumit Das, a psychiatrist from Kolkata notes, “Pharmaceutical companies exist to do business and make profits. But what about doctors? They too put pressure on pharmaceutical companies, telling them, ‘If I prescribe your medicines, send me on a tour to Europe.’

“In the field of psychiatry, pharmaceutical companies bring out new medications every day. There is no evidence that the new medications are better than the cheaper and effective medications that are already in use. And keep in mind the fact that our patients don’t take these medications for just a few days, but often for months or even longer. Yet these unnecessarily expensive medicines are sold and also prescribed.”

“Pharmaceutical companies could have donated money to our department and our institution by cheque. But instead of doing that, I would repeatedly be offered personal gifts, foreign trips, etc. Those salesmen would tell me openly that they are willing to spend on an individual, not on the institution,’ comments a general surgeon from a metropolitan city.

A paediatrician from a metropolitan city suggests, “The practice of pharma companies sponsoring doctors for conferences and CME (Continuing Medical Education) workshops must be stopped immediately.”

A gynaecologist from a big city observes, “The area manager of a pharmaceutical company once paid me a visit along with his army of representatives. He asked me why I regularly use a certain product manufactured by them.

“I answered, ‘It is cheap, it is effective. That’s why.’

“He was confused. He asked me in bewilderment, ‘Madam, we never give you any gifts.’

“I replied, ‘There is no need for that.’

“He just could not believe it. He kept asking, ‘How can this be, madam? Please tell me the reason.’

“This is the ridiculous situation that prevails. This is the reality.”

A paediatrician from a big city mentions, “Our branch [of a doctors’ association] was functioning well. We would organize CME workshops with our own funds. Gradually, the pharmaceutical companies pushed their way in. From 1995 onwards they began to organize their own CME workshops. Earlier, we would focus on the issues of importance that we had decided upon. But then the pharmaceutical companies began to select only those topics that would help them promote their new drugs. The workshops were free, with liquor thrown in. Finally the doctors in our city decided that all workshops henceforth would be organized by the pharmaceutical companies. I would ask them why they couldn’t spend Rs 1000 per year on their own education. Why do you want it free? Finally, through a secret ballot, my opposition was set aside and the basic principles of our [doctors’ association] branch were changed in favour of the pharma companies. Obviously, I withdrew from it. Now all workshops in our city are conducted by pharmaceutical companies.”

“A rampant malpractice is in the area of prescribing vaccines—it is organized, and takes place on a large-scale in planned fashion. The practitioner gets a cut on the Maximum Retail Price (MRP). The more expensive the vaccine, the higher the cut. The cut is even more than the consultation fee. The doctor gets both—the cut from the company and the fee from the patient,” notes Dr Vandana Prasad, a paediatrician from Delhi.

“The pharmaceutical companies are like a pack of wolves. They keep pestering you and encourage you to accept some incentives. Once you take anything from them, they immediately become arrogant. Now they begin to ask you directly, ‘Why don’t you prescribe our medicine?’ They start dictating terms, and because you have accepted money and gifts, you are morally bound to them,” Dr Sanjay Bhatnagar, a paediatrician from Delhi, also shares.

A surgeon from a megacity mentions, “The government cannot provide funds, and if the pharmaceutical companies therefore sponsor conferences in a transparent manner, there is nothing wrong with it. The MCI wanted to do something about this.”

A skin specialist from a big city says, “The pharmaceutical companies have created mayhem. Things like conference sponsorship by drug companies must be stopped. The MCI is aware of the problem, but there are lots of loopholes that can be exploited. Nowadays, doctors take money from pharmaceutical companies and prescribe ten to twenty medicines in a single prescription. There is always an antioxidant tablet prescribed, whether it serves any purpose or not.”

A skin specialist from Kolkata, Dr Jayant Das also remarks, ‘Now pharmaceutical companies are resorting to a new strategy. “For example, they don’t even produce Doxycycline (an established antibiotic) capsules, which cost less than Re 1 per capsule. Instead, they add a useless component like lactobacillus with Doxycycline, and then sell each of those capsules for Rs 5. And when the ordinary, cheap Doxycycline capsule is not even available in the market by design, one has no choice but to prescribe the expensive medicine. This is happening without any check with respect to many medications. One company recently withdrew a medication available for Rs 2. They made some token changes in the formulation and the same tablet is now sold by them for Rs 15!”

Another skin specialist from a big city observes, “Pharmaceutical companies try to give money to doctors under the pretext of conducting studies on their medicines. Such bogus clinical trials are conducted openly. The doctors lure the patients with the promise that the stated medication has come from abroad, and if you want to have it free, you would have to just sign this form, that’s all! Please sign here. Doctors collect the signatures on the forms. Sometimes they just fill up the details. Once they have given the papers for ten to twelve cases (even without prescribing the medication) they get a cheque from the pharmaceutical company.

“If one puts an end to the money pharmaceutical companies spend on doctors, medicines will definitely become much cheaper. That must be ensured, for the benefit of patients. Doctors should be legally compelled to prescribe only generic medicines.”

A general surgeon from a big city offers, “Take the example of Lactulose, which is used to treat constipation. It costs about Rs 180 for 200 ml, that is, around Rs 900 a litre. This is a by-product of the sugar industry. Actually, this should cost less than sugar, i.e., less than Rs 60 per kg. Elderly people will be taking this for years together. Shouldn’t the prices of such medicines be regulated? No. The loot continues.”

 

Big Pharma Whistleblower speaks out at the AZK in Germany, 2009

Dr John Rengen Virapen ex big pharmaceutical executive turned whistle blower

Dr John Rengen Virapen – writer of Side Effects: Death. Confessions of a Pharma-Insider –  ex big pharmaceutical executive turns whistle blower.

More information

News drugs and marketing tactics of the pharmaceutical industry

How Big Pharma is Selling Sickness, Alan Cassels, 2012

Alan Cassels was the keynote speaker at the Victoria Seniors Meeting, Febr. 2012.

More information
  • A drug policy researcher for the University of Victoria, Alan Cassels is a known for having a knack for finding and describing the chasm between what the market says and what science does in modern healthcare. Over the past two decades Cassels has spent much of his research energy studying clinical research and the marketing tactics of the pharmaceutical industry, turning some of that research into journalism and books, including international best-sellers Selling Sickness: How the World’s Biggest Pharmaceutical Companies are Turning us All into Patients and The ABC’s of Disease Mongering: An Epidemic in 26 Letters.
  • Watch more pharma videos on @DES_Journal YouTube channel.

Physicians and the Pharmaceutical Industry: are Doctors really immune to Marketing?

Is a Gift Ever Just a Gift?

business-lunch
The free lunches, merchandise, expensive dinners and golfing holidays – they’re all an investment… Pharmaceutical marketing works… Why else would the industry shell out so much money on marketing to doctors? Image Phillip Capper.

2000 Study Abstract

Context
Controversy exists over the fact that physicians have regular contact with the pharmaceutical industry and its sales representatives, who spend a large sum of money each year promoting to them by way of gifts, free meals, travel subsidies, sponsored teachings, and symposia.

Objective
To identify the extent of and attitudes toward the relationship between physicians and the pharmaceutical industry and its representatives and its impact on the knowledge, attitudes, and behavior of physicians.

Data Sources
A MEDLINE search was conducted for English-language articles published from 1994 to present, with review of reference lists from retrieved articles; in addition, an Internet database was searched and 5 key informants were interviewed.

Study Selection
A total of 538 studies that provided data on any of the study questions were targeted for retrieval, 29 of which were included in the analysis.

Data Extraction
Data were extracted by 1 author. Articles using an analytic design were considered to be of higher methodological quality.

Data Synthesis
Physician interactions with pharmaceutical representatives were generally endorsed, began in medical school, and continued at a rate of about 4 times per month. Meetings with pharmaceutical representatives were associated with requests by physicians for adding the drugs to the hospital formulary and changes in prescribing practice. Drug company–sponsored continuing medical education (CME) preferentially highlighted the sponsor’s drug(s) compared with other CME programs. Attending sponsored CME events and accepting funding for travel or lodging for educational symposia were associated with increased prescription rates of the sponsor’s medication. Attending presentations given by pharmaceutical representative speakers was also associated with nonrational prescribing.

Conclusion
The present extent of physician-industry interactions appears to affect prescribing and professional behavior and should be further addressed at the level of policy and education.

There are few issues in medicine that bring clinicians into heated discussion as rapidly as the interaction between the pharmaceutical industry and the medical profession.

  • More than $11 billion is spent each year by pharmaceutical companies in promotion and marketing, $5 billion of which goes to sales representatives.
  • It has been estimated that $8000 to $13,000 is spent per year on each physician.
  • The attitudes about this expensive interaction are divided and contradictory.
    • One study found that 85% of medical students believe it is improper for politicians to accept a gift,
    • whereas only 46% found it improper for themselves to accept a gift of similar value from a pharmaceutical company.
  • Most medical associations have published guidelines to address this controversy. Perhaps the intensity of the discussion is related to the potential consequences were it confirmed that gifts influence prescription of medication that results in increasing cost or negative health outcomes.

This article addresses the question by way of a critical examination of the evidence. Two review articles have addressed the factors affecting drug prescribing, but only 1 has focused on the impact of the physician-industry interaction on the behavior of physicians. This article critically examines the literature and highlights articles with rigorous study methods.

Sources and more information

Champions of Medicine’s next Revolution

Alan Cassels at TEDx Victoria 2013

A drug policy researcher for the University of Victoria, Alan Cassels is a known for having a knack for finding and describing the chasm between what the market says and what science does in modern healthcare. Over the past two decades Cassels has spent much of his research energy studying clinical research and the marketing tactics of the pharmaceutical industry, turning some of that research into journalism and books, including international best-sellers Selling Sickness: How the World’s Biggest Pharmaceutical Companies are Turning us All into Patients and The ABC’s of Disease Mongering: An Epidemic in 26 Letters.

More information

Free yourself from drug reps

The No Ads Please campaign

Doctors who see medical representatives are more likely to prescribe more medication, more expensively and less according to accepted guidelines. The No Advertising Please campaign encourages doctors to avoid using drug representatives as their “educational” resource, by pledging to not see drug reps at their practice for one year.

Free Yourself from drug reps poster
Watch @DES_Journal diaporama and posters album on Flickr
a #NoAdsPlease poster by the @NoAdsPlease campaign.

Sources and more information

On Flickr®

Say No to the Sandwich

Free Yourself from Drug Reps – the No Ads Please campaign

Doctors who see medical representatives are more likely to prescribe more medication, more expensively and less according to accepted guidelines. The No Advertising Please campaign encourages doctors to avoid using drug representatives as their “educational” resource, by pledging to not see drug reps at their practice for one year.

Say-No-Sandwich poster
Watch @DES_Journal diaporama and posters album on Flickr
a #NoAdsPlease poster by the @NoAdsPlease campaign.

Sources and more information

On Flickr®