Greg Thorpe originally blew the whistle on GSK’s fraudulent activity- and it was as a direct result of Greg’s actions- that GSK were fined 3 Billion in 2012 by the department of Justice. Greg regularly leaves comments on this blog, and they are always extremely interesting, particularly in relation to the department of Justice- GSK fine -debacle.
I call this scandal a debacle because I have long thought that GSK’s fine of 3 billion, and the corporate integrity agreement etc, was merely a little slap on the wrist for GSK. People died because of GSK’s various unethical shenanigans; crimes committed by GSK over many years: many patients were harmed, maimed or killed. GSK should have had its license to trade revoked, instead the department of Justice fined them 3 months profits and allowed to them continue on -business as usual. The executives all sailed off into the sunset, dripping with even more wealth and money than they had previously earned – golden parachutes all-round for the GSK top brass-despite being party to the biggest health care fraud of the 21st century.
Astounding isn’t it?
I’ve always felt that the whole thing stank to high heaven, and furthermore, I have always wondered, why is Greg the only whistle-blower willing to tell the truth about this sham fine?
There were, apparently, another 5 whistle-blowers- why do they not speak out about the quid pro quo? Why do they not criticize Eric Holder and the revolving door? Why do they not speak out about this grave travesty of justice to consumers and patients? Why do they not speak about this slap on the wrist for GSK? Why do they not tell the public that far from being a success for patients, this fine was merely a sleight of hand and a smokescreen?- as GSK were allowed to continue on- as evident by their China-Bribe scandal in 214, to commit more bribery and fraud in different countries, further afield.
Why do they not inform the public about the real scandals of this debacle?
Thankfully, we have people like Greg, he’s not afraid to speak out- here is his latest comment-
There are hundreds if not thousands in the DOJ that are to say the least, are not interested in real justice or the truth. They are not in lockstep with Jeff Sessions to say the least. They regularly monitor this site. Truthman knows this. I hate to coin a phrase, but this swamp cannot be fully drained.
I have been threatened and put myself at risk with everything I say…they violated my constitutional rights by putting a gag order on me for 9 1/2 years…so GSK could continue to reap off label marketing profits and worst of all patients and physicians were kept in the dark. The law I filed under, the False Claims Act has no provision for this conduct, for such a length of time. They are allowed to seal the case only to investigate whether it has merit. I was interviewed under oath by the FBI…3 months after I filed. every government agency was present who had a stake in the case…DEA, HHS, FDA, DOD, IRS, CIA, VA ,DOJ, FBI and others…Shortly after that, I was informed through Counsel that DOJ had dozens of people on the case, and a entire floor at DOJ working on the case. I assume this was true. The False Claims Act seal is to only be extended after they decide to take the case, usually 6 months, for good cause. Obviously it became apparent after 9 years that the seal only remained in place so DOJ could secretly, without public knowledge cut a deal with GSK or go to trial. During this long, long period of time, I was never told that they had joined my complaint until the 11th hour AFTER the settlement was reached. They used this tactic to threaten me with non joining and tossing me out for 9 years plus. During this time, patients continued to receive prescriptions on the 9 drugs I reported …physicians were kept in the dark. In short, the carnage continued…I consistently objected but to no avail. The lead prosecutor told me after I demanded that this go to trial that they “would bankrupt the company, and nobody would get anything”…at the time I thought the statement may have merit, although I now know it was sheer B.S. It would be hard to bankrupt a company with a market cap approaching 200 billion dollars or more.. So I kept my mouth shut while people died, and that haunts me to this day. It included my mother who developed congestive heart failure while kept on Avandia, for diabetes. I did not know GSK had hidden data showing it caused CHF, until it was too late. Hundreds of thousands of patients suffered the same effect, and this was going on with all the drugs reported…but did the DOJ care. Hell no they kept all of this important data sealed from patients and physicians. Why ?
The only reason I know now was to negotiate a sweetheart deal for GSK under a former attorney for the company….ERIC HOLDER. Holder was supposed to have recused himself. I have no evidence that he did. I BELIEVE after he gave GSK the quid pro quo for his law firm, Covington Burling….IN A FINE THAT AMOUNTED TO 3 MONTHS OF COMPANY PROFIT..that he had his hand on the trigger. Supporting this is the fact that he returned to Covington Burling to what has been reported as a “hero’s welcome and a huge raise”.They were even nice enough to give him his old office back, supposedly saved for his return. Holder committed many acts as Attorney General which warrant investigation …but none of this caliber.
GSK lost 3 billion dollars…one month of profit. Nobody was prosecuted .
Nine and one half YEARS is a long time…especially to rob the taxpayers who fund these illegal prescriptions of 40-50 billion dollars, at least. This would not even be what the punishment calls for under the statute. People should be in prison and maybe the company should be bankrupt…they continued the crimes all over the world after the settlement, while under 3 corporate integrity agreements, which called for the so called “death penalty” meaning no Federal program Medicare, Medicaid, VA, etc could use ANY GSK drug..
Why? It defies anything I can come up with except massive criminal fraud and corruption at the highest levels of government. This is a huge story, what I saw and heard over ten years makes me literally sick…yet Nobody seemingly will say anything…the other , second to file whistleblowers, were a joke…copied my complaint, took their money and hid . Mere accomplices to the crimes in my opinion.
Do I fear retaliation for what I say…hell yes I do, but someone has to speak up on this.
I am hopeful someone in the DOJ will come forward, everyone cannot be corrupt or cowardly and I hope we will see under a new administration, something done.
As to the post about Jeff Sessions.. the answer is I don’t know what he can or will do. All I know is my son was in second grade when this began , now he is about to graduate from college. This hasn’t been easy for my family or me and I’m not sure if the swamp can ever be drained. I know a lot more, but someone in the DOJ has inside information…I hope they come forward. The lead investigator, Sara Bloom …would be a good start.
From Compliance Week-
How did GSK obtain a declination?
Bill Coffin | November 22, 2016
Back in September, our old compliance friend GlaxoSmithKline plc (GSK) settled with the Securities and Exchange Commission for violating various provisions of the Foreign Corrupt Practices Act, namely for improper payments, gifts, and other bribes made by GSK subsidiaries in China to Chinese officials to boost sales in that country. Back in 2013, GSK got itself into trouble for a wide-ranging bribery scheme in China, which included the involvement of top-level country managers down to individual sales personnel. The bribery schemes were numerous, including direct bribe payments to all healthcare personnel (HCPs) who could be influenced to prescribe the company’s pharmaceutical products, indirect payments to hospital administrators who could then dole out the money, excessive and over the top gifts, travel and entertainment, and very large payments for speaking events. According to the SEC, the corruption within GSK’s China unit was pervasive, with bribes actually written into the sales plan for the company.
For this, the SEC fined GSK $20 million and declined to prosecute, citing GSK’s cooperation with the Commission during its investigation and global remedial actions taken by GSK to eliminate payments to doctors, improve risk assessment, and improve third-party oversight. This declination might have made more sense with a different company. But this is GlaxoSmithKline here, and this was hardly the company’s first brush with the law, nor its most severe.
Corporate integrity agreement. In July 2012, GSK pled guilty and paid $3 billion to resolve fraud allegations and failure to report safety data and for false price-reporting practices in what the Justice Department at the time called the largest healthcare fraud settlement in U.S. history and the largest payment ever by a drug company for legal violations.
You would think that any company that has paid $3 billion in fines and penalties for fraudulent actions would take all steps possible not to engage in bribery and corruption. Indeed, as part of that settlement, GSK agreed to a Corporate Integrity Agreement (CIA) that applied not only to the specific pharmaceutical regulations that GSK violated but all of GSK’s compliance obligations, including the Foreign Corrupt Practices Act (FCPA).
In addition to requiring a full and complete compliance program, the CIA specified that the company would have a compliance committee, inclusive of the compliance officer and other members of senior management, whose job was to oversee full implementation of the CIA and all compliance functions at the company. These additional functions required deputy compliance officers for each commercial business unit, integrity champions within each business unit, management accountability, and certifications from each business unit. Training of GSK employees was also specified. Further, there was detail down to specifically state that all compliance obligations applied to “contractors, sub-contractors, agents, and other persons (including, but not limited to, third-party vendors).” So, while GSK may have separate FCPA liabilities to be investigated by the Justice Department; it may be more of an issue that the company could be in violation of its CIA.
“Transparency is what enables the public to understand why particular results are reached in particular cases and helps to reduce any incorrect perception that our enforcement decisions may be unreasoned or inconsistent.”
Leslie Caldwell, Assistant Attorney General
Chinese criminal conviction. But that is not all. In September 2014, barely two years after its historic DoJ settlement, GSK was convicted in a secret trial in a court in the Hunan province of China for bribery and corruption related to its Chinese business unit. The amount of the fine was approximately $490 million, roughly equal to the 3 billion Rmb that Chinese investigators alleged that GSK had paid in bribes. Five GSK senior executives from this China business unit were also convicted. Mark Reilly, the former head of GSK in China, was sentenced to prison for three years with a four-year suspension. He was deported and reportedly has left the company. Zhang Guowei, GSK China’s former human resources director, was sentenced to three years in prison with a three-year suspension. Liang Hong, GSK’s former China unit vice president and operations manager, was sentenced to two years in prison with a three-year suspension. Zhao Hongyan, GSK China’s former legal-affairs director, was sentenced to two years in prison with a two-year suspension. Finally, Huang Huang, the GSK China business-development manager, was sentenced to three years in prison with a four-year suspension.
There is even more. The New York Times recently ran a front-page story about GSK and China, focusing not so much on the bribery schemes or individuals, but on GSK’s inept response to whistleblowers’ allegations of bribery and corruption in the company’s Chinese business unit. “The Glaxo case was fueled by missed clues, poor communication, and a willful avoidance of the facts,” the Times wrote. “For more than a year the drug maker brushed aside repeated warnings from a whistleblower about systemic fraud and corruption in its China operations.”
It turned out that the company had received substantive information concerning the bribery schemes by way of e-mail, written in excellent English about the company’s operations in China. Yet the GSK response was to try “another common gambit in China: bribing officials” who were doing the investigating. The company “set up a special ‘crisis management’ team in China and began offering money and gifts to regulators.”
In the midst of this corruption investigation crisis, the company received a video of its country manager, Mark Reilly, having sex with a Chinese woman. An e-mail alleged that a Chinese company, seeking to corruptly gain business favors with Reilly and seek additional business with GSK China, provided the woman. GSK officials in London thought this sex tape video was the work of the same person who was the whistleblower for the corruption allegations against the company and set out to discover the identity of the corruption whistleblower, as well as the sex tape whistleblower. Rather amazingly, GSK’s internal investigation turned up no evidence of bribery in its Chinese business unit, in spite of the detailed information provided by the whistleblower for the corruption allegations. At some point the whistleblower for the corruption allegations provided the same information to Chinese authorities, and this led to arrests of GSK China personnel in late June and July 2013.
The DoJ’s declination order did not reference the Chinese trial, penalty, or investigation and seemed to sidestep GSK’s still-existing CIA for their prior violations and all of the facts developed in the Chinese governmental investigation of GSK. Assistant Attorney General Leslie Caldwell has consistently communicated that the Justice Department is committed to the international fight against corruption, often leading the way. The Department has been training prosecutors from other nations in the techniques of investigating corruption and enforcement of anti-bribery laws.
Moreover, with this increase in the international fight against bribery and corruption, it would seem appropriate that a company not be double penalized by paying a penalty for the same offenses in multiple countries. However, if the Justice Department were providing such credit to GSK, it would seem appropriate that such information be communicated to heighten the transparency around the entire process. From the outside, it does not appear that GSK met at least two of the four prongs required under the FCPA Pilot Program. GSK did not self-disclose the violations of its Chinese business unit and did not cooperate with the authorities. While there were certainly some remedial steps taken by the company in China, they have not been detailed in any manner.
Whatever the reason for the declination, it would have been much better if the Justice Department had been more transparent in their decision-making calculus. Indeed, in recent remarks at the George Washington University School of Law, Caldwell spoke about the importance of transparency in the process. She said, “Transparency is what enables the public to understand why particular results are reached in particular cases and helps to reduce any incorrect perception that our enforcement decisions may be unreasoned or inconsistent. Transparency also informs corporate actors and their advisers what conduct will result in what penalties and what sort of credit they can receive for self-disclosure and cooperation with an investigation.”
Just how GSK was able to get a complete pass from the Justice Department may well remain a mystery, and such mysteries do no one any good.
Interesting to note that, despite leading to a 3 Billion dollar fine, and despite immense detail and its huge scope, Whistle-Blower Greg Thorpe’s 7th Amended Complaint resulted in no jail time for any GSK executives. In retrospect it seems that GSK’s 3 billion fine was a slap on the wrist for GSK (and perhaps the revolving door between GSK and the department of justice had something to do with that?) and then it was business as usual. Until high level executives in these corrupt companies are held to account for their role in these scams, nothing will change…
Former Pharma Exec Heads To Trial On Kickback Allegations
By Ed Silverman @Pharmalot
May 17, 2016
Between 2009 and 2012, W. Carl Reichel allegedly orchestrated a campaign to give doctors money, free meals, and phony speaking fees in exchange for prescribing medicines sold by Warner-Chilcott, where he had been the president of the pharmaceutical division, according to federal prosecutors.
Next week, he goes on trial in what is expected to be a closely watched case in the pharmaceutical industry. That’s because the case marks one of the relatively few instances in which federal prosecutors have sought to hold a high-ranking executive from a drug maker accountable for such activities.
“To the extent the executive is convicted, it will impact the industry,” said Anne Walsh, a former associate chief counsel at the US Food and Drug Administration who is now a director at Hyman, Phelps & McNamara, a law firm that specializes in regulatory matters.
To be sure, other drug company executives have faced penalties for illegal activities. Notably, three former executives at Purdue Pharma pleaded guilty in 2007 to misleading the public about the risk of addiction posed by the OxyContin painkiller. They were also banned from any dealings with federal health care programs, notably, Medicare and Medicaid.
But such instances are relatively rare in the pharmaceutical industry, even as a parade of drug makers has paid large fines for civil and criminal violations. Moreover, the Reichel trial gets under way just eight months after the US Department of Justice issued a memo that serves as a blueprint for pursuing individuals who engage in corporate malfeasance.
Former sales rep for opioid drug maker pleads guilty to kickbacks
There is now a “more uniform, systematic, and sustained focus on individuals,” said Sally Yates, a US Deputy Attorney General at a New York City Bar Association meeting last week. She originally issued the DOJ memo.
“There is one system of justice — one in which wrongdoers can and must be held accountable based on facts and evidence, not on position or title, power or wealth,” she said.
The emphasis on individuals also emerges after a drop-off in the number of settlements that the Justice Department has reached with drug makers for illegal activities, such as paying kickbacks to physicians or illegally marketing medicines. From a high of 18 deals in 2013, which capped a rising trend, the number of settlements fell to 11 last year, according to data compiled by Public Citizen.
In the Reichel case, the feds allege that he developed and oversaw an illegal strategy to boost prescriptions for several drugs, including the Actonel osteoporosis treatment and the Doryx acne medicine. Among the charges: Reichel provided sales reps with unlimited expense accounts in order to wine and dine doctors, and he suggested targeting doctors who were already frequent prescribers, according to the indictment.
He faces no more than five years in prison, three years of supervised release, and a fine of $250,000. We asked his attorney for comment and will update you accordingly.
“I think the Justice Department needs and wants to send a signal,” said Patrick Burns of Taxpayers Against Fraud, a nonprofit that that advocates for tough penalties and is partially funded by attorneys. ”I hope this will become a larger effort to bring personal accountability to corporate suites, because if they bring pain to the executive, it will bring change to the corporation.”
At the time that Reichel was indicated last fall, Allergan, which now owns Warner-Chilcott, agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil charges in connection with illegally promoting several drugs, according to the settlement.
Three former sales managers — Timothy Garcia, Landon Eckles, and Jeff Podolsky — also pleaded guilty for directing sales reps to access confidential patient data after insurers denied coverage for the drugs. The company sought the patient data in order to submit what are called prior authorization forms, which refer to specific requests made by doctors to insurers to provide coverage for a medicine.
They each face no more than 10 years in prison, three years of supervised release, and a fine of $250,000. Their respective sentencings will not occur until between July and September.
Ed Silverman can be reached at email@example.com
Follow Ed on Twitter @Pharmalot
Appendix A: Section IX of United States of America vs. GlaxoSmithKline, PLC
1. GSK’S OFF-LABEL MARKETING OF LAMICTAL
- In December 1994, Lamictal (active ingredient lamotrigine) was FDA approved for use as adjunctive therapy in adults with partial seizures, and as adjunctive therapy in the generalized seizures of Lennox-Gastaut syndrome in adults and pediatric patients ages two and older.
- However, despite the narrow indications for which it was approved, GSK heavily marketed Lamictal for the treatment of bipolar disorders both before and during the period it was pending a supplemental new drug application for treatment of bipolar I disorder, which was finally granted by the FDA on June 20, 2003.
2. Off-Label Promotion to Bipolar Patients
- GSK’s aggressive marketing of Lamictal prior to its approval for use in the treatment of bipolar I disorder proved extremely lucrative. Lamictal grew by 33% in the year 2000 (with total U.S. sales of $210 million) and continued to grow in the following years. In a press announcement for year 2003 GSK boasted that Lamictal was approaching ‘blockbuster status’ with sales that grew by 31% to approximately $1 billion.
- Curiously, there is no data that would support a commensurate rise in partial seizures in adults or Lennox-Gastaut Syndrome, the only approved indications for Lamictal prior to June of 2003.
- Ultimately, the aggressive and illegal pre-approval marketing served the dual purpose of reaping significant gains prior to approval for treatment of bipolar I disorder as well as assuring GSK of a nationwide network of health care providers ready to prescribe the drug for bipolar disorders the minute it received FDA approval.
- Over the course of nearly ten years of off-label marketing of Lamictal, billions of dollars in sales were generated prior to the 2003 indication for bipolar I, as alleged infra.
- Accordingly, GSK, in promoting Lamictal by willfully misrepresenting the FDA approved uses, engaged in egregious and knowing off-label marketing.
3. Off Label Promotion for all Bipolar Disorders
- Despite the fact that Lamictal was only FDA approved for treatment of partial onset seizures in 1994, since its launch, sales representatives were trained to promote the drug as an effective treatment for all bipolar disorders.
- Although there are several types of bi-polar disorders, as alleged infra, bipolar I is the most severe and the most rare. Notably, the drug was never approved by the FDA for bipolar II disorder or any of the four (4) other variations on bipolar disorder listed below.
- Bipolar I disorder involves episodes of severe mood swings, from mania to depression.
- Bipolar II disorder is a milder form, involving milder episodes of hypomania that alternate with depression. Bipolar II is a more broadly defined mental illness and encompasses more patients.
- Cyclothymic disorder describes even milder mood changes.
- With mixed bipolar disorder, there is both mania and depression at the same time, resulting in a person having feelings of grandiosity and racing thoughts, often resulting in an irritable, angry and moody feeling.
- Rapid-cycling bipolar disorder is characterized by four or more mood episodes that occur within a 12-month period. Some people experience multiple episodes within a single week, or even within a single day. Rapid cycling tends to develop later in the course of illness. Women are more likely than men to have rapid cycling. A rapid-cycling pattern increases risk for severe depression and suicide attempts.
- Despite the lack of any bipolar related indication until 2003, sales representatives were provided with materials designed to promote the drug for global bipolar disorders. Even after it received approval for bipolar I disorder in 2003, sales representatives were trained not to call attention to the distinctions among the various types of bipolar disorder unless a physician inquired.
- As evidence of the pre-indication marketing and training, one need look no further than the 2001 GSK Selling Resource Guide for Lamictal. The Resource Guide provides scripts for sales reps to address requests for information on Lamictal and bipolar depression suggesting that there were numerous inquiries into this usage. 7AC 0000413-0000430.
- In furtherance of their bipolar marketing efforts, GSK engaged in an aggressive campaign aimed at pushing sales representatives to use the FaxBack program discussed in the Resource Guide as a marketing tool.
- Specifically, in the aforementioned 2001 Resource Guide, sales representatives were instructed to direct the physicians to “Faxback Number 5” for information regarding the use of Lamictal and bipolar disorder. This faxback incorporated the findings of Dr. Joseph R. Calabrese, and others, which positively detailed the use of Lamictal in patients suffering from bipolar I and II, mania, unipolar depression, and as a monotherapy. 7AC 0000419
- Most troublesome is the fact that GSK was aware of its illegal strategic use of the FaxBack program, yet made a conscious and deliberate effort to cover up its actions.
- For example, at a management training program in July 2002, Relator Hamrick was instructed by a manager-in-training that, with respect to the detailing of Lamictal for bipolar to psychiatrists, the record of every contact report should automatically include the phrase ‘Dr. inquired about bipolar disorder” thereby effectively circumventing the requirements of the FDCA with regards to disseminating literature concerning non-approved uses.
- In addition to the FaxBacks, GSK frequently distributed “Lit Alerts” to its sales force allegedly for the purpose of educating the drug reps. The Alerts, essentially a cliff-note version of a drug specific study, were routinely carried by sales representatives to aid in answering any questions posed by physicians. The fact that the Lit Alerts were, by their very nature, off label marketing tools, makes their distribution by GSK even more egregious.
- Specifically, in August 2002, a Lit Alert was distributed to Lamictal sales representatives discussing the use of Lamotrigine as an augmentation agent in treatment resistant depression (‘TRD’), a use for which it has never received approval. 7AC 0000431-0000433.
- Subsequent to the TRD Lit Alert, in April 2003 GSK distributed another study titled ‘Lamictal as Maintenance Treatment in Recently Manic or Hypomanic Bipolar I Patients.’ This Lit Alert served only to fan the flames of an already rampant bipolar campaign and was referenced widely in sales calls. 7AC 0000434-0000438.
- Just as troublesome as the Lit Alerts and Faxbacks, were the numerous studies by Calabrese, distributed by GSK, which suggest the efficacy and use of Lamictal in patients with bipolar II.
- Although Lamictal never received an indication for bipolar II disorder, GSK maintained its effective off label campaign and continued to forge strong relationships with its prescribing physicians ultimately pushing the boundaries by suggesting Lamictal’s effectiveness as a treatment option for bipolar II disorder.
- In fact, since the dosage of Lamictal must be increased slowly from a subtherapeutic level to a therapeutic level, acute mania and Bipolar II never received an indication.
4. GSK’s Improper Use of National Thought Leaders to Promote the Off-Label Marketing of Lamictal
- GSK’s extremely aggressive off-label campaign for Lamictal included spending large sums of money in the form of unrestricted grants, membership on advisory boards and speaker’s fees on physicians and researchers who served as ‘national thought leaders.’ As with campaigns for other drugs, the campaign for the use of the drug Lamictal in the treatment of bipolar disorders began with the widespread promotion of “disease awareness.”
- Key figures in GSK’s national promotion of Lamictal for treatment of bipolar disorders prior to its indication were Dr. Joseph R. Calabrese of Cleveland, Ohio and Dr. Charles L. Bowden of San Antonio, Texas.
- As previously discussed, Dr. Calabrese, in particular, was GSK’s greatest proponent for the use of Lamictal in the treatment of bipolar disorders and published articles advocating the use of Lamictal in bipolar disorder as early as 1998. Dr. Calabrese has widely published his opinion that there is need for a greater awareness of the prevalence of bipolar disorders in the United States, stating that the disease impacts as many as 4% of the total population (11,000,000 people) yet is ‘largely undiagnosed.’
- In his promotion of the use of Lamictal for bipolar disorder, Dr. Calabrese wrote about a new nomenclature (‘above the line/below the line’) advocating that Lamictal was clearly superior to other commonly prescribed medications such as Lithium. Dr. Calabrese also defended the drug from the accusation that the risk of serious side-effects, such as Stevens- Johnson Syndrome4, outweighed the benefits of prescribing the medication.
4 Stevens-Johnson syndrome is a rare, serious disorder in which the skin and mucous membranes react severely to a medication, in this case, Lamictal, or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed. 4612704 117
- In addition to journal articles, in 2002 Dr. Calabrese even published a greatly abbreviated, highly commercialized version, of his 1998 study (being careful to identify Lamotrigine by its GSK product title Lamictal) in an internet bulletin called “Fast Breaking Comments.” In this interview, Dr. Calabrese blatantly publicizes his determination that “lamotrigine (Lamictal) is effective in the treatment of patients with rapid cycling bipolar II disorder.” 7AC 0000439-0000441.
- To date, Lamictal has not received an indication for rapid cycling bipolar II disorder. However, GSK placed great emphasis on this study and sales representatives were expected to read and be familiar with Dr. Calabrese’s theories and statistics for use in off label marketing.
- Dr. Bowden began publishing his opinions concerning the efficacy of Lamictal in the treatment of bipolar disorder as early as 1998. Dr. Bowden became a widely sought after speaker for GSK, and GSK sales representatives nationwide were encouraged to try to persuade Dr. Bowden to make presentations on his findings in their geographical area.
5. GSK’s Off-Label Marketing to Psychiatrists
- Seizure disorders – the only approved indication for Lamictal during the 1998 through 2003 period – were treated by neurologists, not psychiatrists. Notwithstanding that fact, GSK began requiring its sales representatives to detail Lamictal with psychiatrists and family practitioners many years before the approval for bipolar I disorder.
- It is clear that these ‘details,’ which were prevalent throughout the nation during this period, were directed at persuading physicians to prescribe Lamictal off-label for the treatment of bipolar disorder and through the use of free samples, ‘thought leader’ lunches, dinners and CME’s, and distribution of studies favorable to GSK, particularly the Calabrese 4612704 118 studies, GSK was extremely successful in persuading physicians to begin prescribing the drug off-label.
- As confirmation of the detailing of psychiatrists, a quick review of the contact sheets written up by the sales representatives shortly after the physician visits confirm the fact that the purpose of these visits was solely to market Lamictal for the treatment of bipolar disorders. The following is representative of the quantity of the off label physician visits by sales representatives including Ron Crews, Joan Schindler and Betty Hosler5
- 9/13/00 Dr. Douglas Gregory (psychiatrist) ‘Had long discussion about Lamictal, is afraid of rash….Rash is severe side effect which has caused death in several patients….’Stevens Johnson Syndrome’….Gave him Calabrese article and encouraged him to talk to Marciniak [local GKS ‘thought leader’;
- 10/18/00 Dr. McClure [Dr. Scott H. McClure, psychiatrist] Is getting more comf w/ lamic, thought it [conference put on by GSK]was informative More comfortable with Lamictal for bi-polar;
- 10/26/00 Dr. Crandall (psychiatrist) “[D]iscussed Bowdens’ lecture, she is afraid of the rash;
- 10/30/00 Dr. Gamblin (psychiatrist) ‘very pos. about lam. (Lamictal) has over 50 patients on it’…’Trained with Bowden sorry he missed it ‘ (referring to lecture in Colorado Springs that GSK arranged with Dr. Bowden as the speakers);
- 10/30/00 Dr. McClure [Dr. Scott H. McClure, psychiatrist] ‘Said he is more comf.with Lamictal as monotherapy [in the treatment of bipolar disorder] after hearing Bowden likes the bottles of 25 only, not the kits (Lamictal) samples’;
- 1/8/01 Dr. Harazin [Dr. Jeffrey Harazin, psychiatrist] ‘Lamictal is on it’s way’;
- 03/21/01 Dr. Marciniak [psychiatrist] detailed by GSK District Manager for Lamictal in bipolar;
- 05/23/01 Dr. Gregory [psychiatrist] attended noon lecture at Pikes Peak Mental Health with Dr. Paul Wender speaking, detailed on Lamictal;
5 These notes have been reproduced exactly as they were written in the contact reports by the individual sales representatives and entered into the Passport system following each sales call.
- 06/12/01 Dr. Gamblin [psychiatrist] again detailed on Lamictal;
- 06/19/01 Dr. Richard Marciniak [psychiatrist] detailed on Lamictal and offered a free fly fishing trip;
- 06/21/01 Dr. Richard Marciniak again detailed on Lamictal and offered speaker/dinner engagement at local restaurant (Warehouse);
- 07/05/01 Dr. Gamblin again detailed for Lamictal;
- 07/19/01 Dr. Richard Marciniak again detailed on Lamictal and stated it is his choice for treatment of bipolar, as well as discussing dosage amounts and titration;
- 07/30/01 Dr. Fred Michel detailed on the use of Lamictal for the treatment of children (‘Uses very little Lamictal in kids but would like to use it more.’);
- 03/14/02 Dr. Julie Sanford [psychiatrist] detailed for using Lamictal in the treatment of bipolar;
- 03/15/02 Dr. Gamblin had not yet seen the Calabrese study but did not want to drive to Denver for CME’s;
- 03/15/02 Dr. James Spadoni [psychiatrist] detailed for the use of Lamictal in bipolar;
- 03/19/02 Dr. Marciniak agreed to be paid by GSK to speak about Lamictal for bipolar as well as Wellbutrin at a lunch for local physicians in Colorado Springs;
- 03/19/02 Dr. Stephen Mueller [psychiatrist] confirmed attendance at the bipolar/Lamictal physician’s meeting in Colorado Springs, Colorado;
- 03/20/02 Dr. Gamblin again detailed for prescribing Lamictal for bipolar disorder;
- 04/03/02 Dr. Marciniak detailed for Lamictal and confirmed that he would accept paid assignment to do GSK’s CME program on June 7, 2002;
- 04/03/02 Dr. Spadoni [psychiatrist] detailed for use of Lamictal in bipolar disorder;
- 04/10/02 Dr. Gamblin detailed for use of Lamictal in bipolar disorder with reference to the Calabreze study;
- 04/24/02 Dr. David Caster [psychiatrist] detailed for Lamictal in bipolar disorder;
- 04/25/02 Dr. Rosalyn Kneppel [psychiatrist] detailed for Lamictal in bipolar disorder;
- 04/29/02 Dr. Nancy Sharpe, a Colorado Springs psychiatrist, was detailed for Lamictal in bipolar disorder; this doctor, who has a large Medicaid practice, asked the GSK sales representative about proper dosage amounts;
- 05/01/02 Dr. Brian Grabert, a pediatric neurologist, was invited to be on GSK’s advisory board for an upcoming San Diego, California conference; 05/06/02 Dr. Gamblin detailed once again for Lamictal and now said he feels quite comfortable using it;
- 05/08/02 Dr. Rosalyn Kneppel [psychiatrist] again detailed for Lamictal in bipolar disorder;
- 05/08/02 Dr. Jeffrey Harazin again detailed for Lamictal in bipolar and now said he uses it ‘first line’ for bipolar disorder;
- 05/13/02 Dr. Stephen Mueller, psychiatrist, again detailed for Lamictal in bipolar and requested pricing information;
- 05/17/02 Dr. Marciniak agreed to do a talk and stated that he is using Lamictal more for bipolar now that he has more samples;
- 05/20/02 Dr. Elliott Cohen, psychiatrist, detailed for Lamictal and he requested more samples;
- 05/20/02 Dr. Rosalyn Kneppel [psychiatrist] again detailed for Lamictal in bipolar disorder and said she is using half the dosage [recommended for seizures] because of concerns about the rash;
- 05/20/02 Dr. James Polo detailed for use of Lamictal in bipolar disorder in adolescents;
- 05/22/02 Dr. Ralph Everett, child psychiatrist detailed for Lamictal in bipolar and after having stated he did not like it, was given a comparison to Zoloft by the GSK rep;
- 05/22/02 Dr. Scott McClure, psychiatrist, again detailed for Lamictal in bipolar and Dr. McClure asked the GSK rep. how to dose if a patient was already on Depakote for bipolar and was given ‘the Calabrese study’ by the rep;
- 05/23/02 Psychiatrists Dr. Anne League, Dr. James Spadoni and Dr. Julie Sanford were treated to lunch at a local Colorado Springs restaurant by the GSK sales representative and given American Psychiatric Association guidelines relating to Lamictal;
- 05/23/02 Psychiatrist Pamela A. Brickers of Colorado Springs, CO was detailed by a GSK representative and was given a copy of ‘the calabrfese [sic] study’;
- 05/29/02 Dr. Julie Sanford was detailed on Lamictal for bipolar and the GSK rep went over a study/comparison with Zoloft that was favorable to GSK’s product;
- 05/29/02 Dr. James Spadoni and Dr. Richard Marciniak detailed for Lamictal;
- 05/30/02 Dr. Brian Grabert detailed for Lamictal for his pediatric patients;
- 06/05/02 Dr. Brian Grabert again detailed for Lamictal and discussed the rash;
- 06/17/02 Dr. Honie Crandell again detailed for Lamictal in the treatment of bipolar disorder and confirms that it is her drug of choice for this disorder.
- In addition to targeting psychiatrists for detailing, prior to the FDA approved indication for bipolar I, GSK sales representatives were instructed to devote virtually all of their free sampling activities to psychiatrists, rather than neurologists. A routine practice that was documented in the contact reports of physician details as well as the first-hand experience of Relator Thorpe.
6. GSK’S Off-Label Promotion of Lamictal Resulted in Patient Harm
- Although the FDA issued recommended dosing for Lamictal for its seizure indications, there were no such dosing guidelines for use in patients suffering from any form of bipolar disorder prior to the FDA approval in 2003. As such, there existed an acute risk of overdosing and resulting complications.
- Since the FDA did not establish a recommended dosage for Lamictal for use off label, and because the potential side effects were so severe if not dosed correctly, once the sales representatives had successfully gotten a physician to inquire about its use for bipolar, they were instructed to use the phrase ‘start low and go slow.’
- On information and belief, this “catchphrase” came directly from the GSK marketing department and was used by sales representatives throughout the country as a way to remind physicians to start with a small dose and raise the dosage very slowly in the treatment of bipolar I disorder in children and adolescents especially.
- Given the lack of dosing information, coupled with the intense campaign for use as a treatment for bipolar disorders, the contact reports referenced in the preceding paragraphs evidence physicians routinely inquiring about dosage and titration from the sales representatives themselves.
- On information and belief, as a direct and proximate result of the lack of proper dosing of Lamictal when used off-label, patients suffered both reported and unreported severe side effects including death.
- The Federal Drug and Cosmetic Act (“FDCA”) and its regulations require that adverse events due to prescription medications be promptly reported. However, ample evidence exists of widespread under-reporting of adverse drug reactions, even when drugs are being prescribed for their approved uses. (Mintzes, B., Bassett, K., Wright J.M.. Drug Safety without Borders: Concerns about Bupropion. Can. Med. Assoc. J., 2002;167(5); Moride Y, Haramburu F, Requejo AA, Begaud B. Under-reporting of Adverse Drug Reactions in General Practice. Br J Clin Pharmacol 1997;43(2):177-81; Bates DW. Drugs and Adverse Drug Reactions. How Worried Should We Be? JAMA 1998;279(15):1216-7; Okie, S., Safety in Numbers – Monitoring Risk in Approved Drugs, N.E.J.M., 352:1173-1176, March 2005.)
- On February 14, 2003, Relator Hamrick became aware of an incident involving the dangers of off-label prescription particularly when combined with the widespread laxity in adverse event reporting when he called on Dr. J. Vitanza, an allergist.
- Mr. Hamrick was informed that one of Dr. Vitanza’s patients had been prescribed Lamictal for bipolar I disorder (prior to its approval by the FDA) and noted in the patient’s chart an incidence of rash. Assuming that the patient’s psychiatrist would report the rash incident, Dr. Vitanza failed to report the occurrence to the FDA. After observing that the physician was not going to file an adverse event report, Mr. Hamrick filed his own, based upon his second-hand knowledge of the incident. 7AC 0000442-0000443.
- As a result of the underreporting of rash occurrences, physicians failed to be properly alerted to the potential danger of the rash which had, on a few occurrences, developed into Stevens-Johnson Syndrome.
- In addition to the unreported incidents of rash, often resulting from off-label prescriptions, at least one death resulted from the use Lamictal for bipolar I disorder.
- Dr. Julie Sanford, a psychiatrist who was consistently detailed by GSK sales representatives to prescribe Lamictal for bipolar disorders, prescribed the drug for a patient that subsequently died. Since Dr. Sanford was not a neurologist likely to be treating a patient for a seizure disorder, it should have been apparent to GSK officials receiving a copy of her adverse event report that the drug was, in all likelihood, prescribed for a non-indicated use.
- Nevertheless, in a May 22, 2001 letter to Dr. Sanford from GKS’s “Global Clinical Safety and Pharmacovigilance” division, there is a reiteration of adverse event reporting: the patient, who had been given Lamictal experienced headache and died, and other patients of whom she was aware also experienced rashes subsequent to receiving therapy with Lamictal. 7AC 0000444.
- Significantly, the “Global Clinical Safety and Pharmacovigilance” division, while allegedly interested ‘in obtaining as much information as possible concerning reports of suspected adverse reactions for the purpose of continuing to monitor and evaluate drug safety’ made no inquiry into the issue of the purpose of the supposed therapy.
- Of even more concern, in a conversation with Relator Thorpe, Dr. Sanford, a psychiatrist married to key opinion leader Dr. Marciniak, revealed that the patient who died was in fact being treated for bipolar I disorder.
- Clearly, when combined with the lack of recommended dosage, the off-label use of Lamictal made for a recklessly dangerous combination for patients resulting in severe rashes, including Stevens Johnson Syndrome, and even death.
7. GSK Targeted Federal Health Care Programs for Off-Label Use
- GSK’s off-label marketing tactics also helped put their products on Tricare/Champus formularies for uses not approved by the FDA.
- For example, GSK focused on psychiatrist Dr. James Polo because of his position at Evans Army Hospital, Fort Carson, Colorado. As a result of the persistence of GSK, Lamictal was actually placed on formulary for treatment of bipolar disorders prior to receiving such an indication.
- GSK began seriously attempting to influence Dr. Polo in the late 1990’s by making arrangements for and paying for all of the food and liquor at the annual Colorado Spring Psychiatric Association Christmas party at Dr. Polo’s home, with 60-70 physicians in attendance.
- A simple review of just a few GSK contact reports in 2001 and 2002 clearly indicates that GSK sales representatives “detailed” Dr. Polo to enlist his aid in placing Lamictal on the Tricare/Champus formulary at Fort Carson for use in the treatment of bipolar disorders:
- 4/23/02 Dr. James Polo detailed on Lamictal and Wellbutrin, invited to GSK speakers program, ‘he saw the green journal and asked if on lamictal on formulary, he said yes but for neurology only; he will champion it for p.t.’
- 5/20/02 Dr. James Polo detailed on Lamictal with note ‘he was not attending the Tricare meeting this week, wsr for pts. w depression and concentration difficulties, lamictal is now a favorite of his and uses it in adol with bi-polar.’
- 7/15/02 Dr. James Polo detailed on Lamictal and reported that ‘Lamictal is no longer restricted to neurology’ meaning it was now available on the Tricare formulary.
- 07/24/02 Dr. James Polo detailed on Wellbutrin and Lamictal and reported “Lamictal free for all psyches.’
- As evidence of the success of the GSK engineered approval of Lamictal for use as a psychiatric treatment on the Fort Carson Tricare formulary, Dr. Kenneth Gamblin, a high volume Medicaid psychiatrist was told, (according to the July 17, 2002 GSK contact report) about availability of Lamictal on the Tricare formulary. Subsequently, according to the aforementioned contact report, he ‘…has started several new pts.’
- Upon information and belief, GSK targeted other high volume federal healthcare providers for off-label use of Lamictal and by the second quarter of 2007, Lamictal held a 14.1% share of the Medicaid market.”
Behaviorism and Mental Health: Philip Hickey is a retired psychologist. He has worked in prisons (UK and US), addiction units, community mental health centers, nursing homes, and in private practice. He and his wife, Nancy, live in Colorado, and have four grown children. His posts can also be seen on his website, Behaviorism and Mental Health.
Very interesting comparison..
A former user of Avandia (GSK’s heart attack inducing Diabetes drug) asks an important question…
How come Andrew Witty is never held to account for anything that GSK does?
Including the Avandia scandal and the Seroxat scandal- which killed, harmed and maimed many people, where is the accountability? Why is the department of Justice not investigating GSK breaking their corporate integrity agreement? and when will we see the results of the SFO (Serious Fraud Office) investigation into GSK in the UK bear fruit?
CEO accountability selectively enforced
Posted Oct. 9, 2015 at 2:01 AM
So the U.S. Department of Justice says it could seek to hold individual Volkswagen executives accountable for that corporation’s emissions testing scandal — but it’s done nothing to GlaxoSmithKline CEO Andrew Witty for premeditated poisoning for profit with the drug Avandia.
As a victim of this insidious drug, I am appalled at the selective punishment of CEOs by the Justice Department. I guess my life is not as important as car fumes.
The time has come for President Obama to get off the world stage and start protecting “we the people” at home!
Paul G. Redlund