Tagged: Lamictal

Woman Sues GSK For Horrific Lamictal Side Effect….


Khalia Shaw‘s skin was burned from inside out after dosage error. Picture: Journey of a Butterfly

Fox News

A GEORGIA woman who is three years into a painful recovery is suing after claiming she received the wrong dosage of a medication that caused her body to burn from the inside out. Khaliah Shaw, 26, spent three weeks in a medically induced coma while her skin slowly peeled off and wants to ensure that other patients are protected from pharmaceutical errors, 11Alive.com reported.

“This did not have to happen,” Ms Shaw, who lives in Snellville, northeast of Atlanta, told 11Alive.com. “This was not just some sort of fluke in my opinion. This happened as a directly (sic) result of somebody’s error.”

In 2014, Ms Shaw told her doctors she felt depressed and received a prescription for Lamictal, an anti-seizure medication sometimes used to treat bipolar disorders, the Tech Times reported.

Ms Shaw took the medication for two weeks before she started breaking out in blisters. Ms Shaw told the news outlet that her body felt like it “was on fire”.

Eventually, doctors diagnosed her with Stevens Johnson Syndrome, a rare skin disorder that is typically caused by an adverse reaction to medication, 11Alive.com reported.

“It essentially causes your body to burn from the inside out, and you pretty much just melt,” she told 11Alive.com.

Khalia Shaw was diagnosed with Stevens Johnson Syndrome. Picture: Journey of a Butterfly

Khalia Shaw was diagnosed with Stevens Johnson Syndrome. Picture: Journey of a ButterflySource:Supplied

 

The Palm Beach Post reported that others are also suing pharmaceutical company GlaxoSmithKline (GSK) for promoting Lamictal without advertising its risks in full. In July 2012, the pharmaceutical company pleaded guilty to criminal negligent charges for allegations of fraud and failure to report product safety data for the drug, the newspaper reported. GSK paid $3 billion total.

As for Ms Shaw, the young woman has come to resemble a burn victim. She has lost her fingernails and sweat glands, and she is slowly going blind, 11Alive.com reported.

“They’re telling me this could happen again, and they’re telling me if it did happen again, that it would be worse,” Ms Shaw told the news outlet.

The lawsuit claims her medical bills total upwards of $3.45 million and are expected to continue to grow as she continues receiving treatment.

“I never heard of Steven Johnson Syndrome until I was in the hospital with my skin melting off my body. That’s when I learned what it was,” she told the news outlet.

Ms Shaw’s lawyer told 11Alive.com that alleged errors by pharmacists continue to “happen at an alarming rate,” because staff are too rushed and too busy.

In telling her story, Ms Shaw wants to raise awareness about the dangers of prescription medication errors.

“It is difficult being in the spotlight, but I think it is worth it if it means someone is more educated about the medication that they are taking,” Shaw told The Palm Beach Post.

This article originally appeared on Fox News.

GSK’s Lamictal Crimes ..



http://www.madinamerica.com/2015/11/appendix-a-section-ix-of-united-states-of-america-vs-glaxosmithkline-plc-gsks-off-label-marketing-of-lamictal/

Appendix A: Section IX of United States of America vs. GlaxoSmithKline, PLC: GSK’S OFF-LABEL MARKETING OF LAMICTAL

Appendix A: Section IX of United States of America vs. GlaxoSmithKline, PLC

1. GSK’S OFF-LABEL MARKETING OF LAMICTAL

  1. 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.
  1. 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

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  2. 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

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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

  1. 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.”
  1. 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.
  1. 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.’
  1. 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

  1. 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.
  1. 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.
  1. 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

  1. 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.
  1. 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.
  1. 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.
  1. 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

  1. 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.
  1. 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.’
  1. 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.
  1. 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.
  1. 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.
  1. 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.)
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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

  1. GSK’s off-label marketing tactics also helped put their products on Tricare/Champus formularies for uses not approved by the FDA.
  1. 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.
  1. 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.
  1. 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.’
  1. 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.’
  1. 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.”

 

Philip Hickey, PhD

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.

Whistleblower Greg Thorpe’s 7th Amended Complaint..


GREGt“..When you look at the detail and accuracy of Greg Thorpe‘s written complaints distributed to the highest levels of Glaxo (See ‘Document Links’ Below) it’s almost surreal that the company took no corrective action. Now more than a decade later, GSK is essentially admitting that Thorpe had been right in 2001″.. Kenney said

“…As a Colorado Springs sales representative for GlaxoSmithKline, Greg Thorpe tried to put a stop to the practice. His manager wrote him up for not being a “team player” after he objected to the free spa treatments and pedicures, hunting trips, tickets to sports games and skiing junkets that his supervisors expected him to give out to doctors and others..”

“The sky was the limit,” said Thorpe, whose whistle-blower lawsuit against his former employer ended with a $3 billion settlement with the federal government. “Those who spent more money got rewarded because they were positioning the company for more business. And it did pay off.”

“How many kids died from Paxil (and WellButrin) being pushed illegally off label?”

When GSK were fined 3 Billion dollars by the US department of Justice in 2012 (for various criminal/fraudulent activities spanning over more than a decade- which resulted in some cases- in deaths of patients/consumers) the media concentrated mainly on the headline grabbing “3 Billion dollar fine” and very little of the exhibits (and the content of the actual legal complaint) were highlighted. This is understandable, considering this was the biggest health care fine in US history, but the fine itself is only a very small part of the overall story. These exhibits reveal a sinister and sociopathic corporate culture at GSK; a culture which indicate (and considering GSK’s recent China bribe scandal– arguably- still display) an utterly callous disregard for patient health, and an insatiable appetite for fraud and corruption in the pursuit of profits.

The main whistle-blower behind this record breaking fine was a previous employee of GSK- Greg Thorpe. Greg spent 23 years with the company, but when they expected him to get involved in prescribing medications such as the anti-depressant Wellbutrin to kids, Greg felt the need to speak out. Typically, GSK responded by vilifying Greg, and making his life hell. Greg’s original mails (to the GSK upper management -about his absolute unwillingness to participate in these nefarious activities) make for sobering reading. I applaud Greg for his actions, he deserves much praise and respect for doing the right thing. He is a hero (in the true meaning of the word), and he is truly brave and courageous; however I wish I could say the same for the media coverage of the fine itself. Very little of these exhibits were printed online or in broadsheets. The coverage of the finer details was paltry. I always wondered though, why did the department of Justice not go back further than 2000 with the Wellbutrin (off label allegations)? It couldn’t be anything to do with the fact that Andrew Witty was head of marketing around 1997/98 and involved in promoting Wellbutrin also could it? surely not…

Aside from that, I was also disappointed to see that there was very little in this legal complaint about Paxil (Seroxat). However, I have since learned (from my source) that this part of the complaint should have been much longer. Again, I wonder why it was cut short? Another aspect of all this that is interesting is- the fact that there were other whistle-blowers: what was their contribution? What did they know about Paxil (Seroxat) withdrawal/suicides/birth defects etc, or other GSK crimes, where are their complaints and exhibits? Why do we see mostly stuff from Greg in the complaint? (with some input from Blair Hamrick), what did the other whistle-blowers reveal? (if anything at all?) Why do the other four whistle-blowers not speak out at all?

If either whistle-blowers Michael Lafauci, Lois Graydon, Thomas Geraghty, or Matthew Burke are reading this and they would like to contact me about anything in this post, please e-mail : truthman30@gmail.com.

Thanks.

Furthermore, it seems to me that this 3 Billion dollar fine was merely a gift to GSK from Eric Holder, he did say, after all- that some companies were ‘too big to fall’ (he later countered this with a remark that ‘there is no such thing as too big to jail’ but it seems in Glaxo’s case, this wasn’t to be). GSK provide massive employment, investment, research to US states as well as donations to US institutions, academia etc, therefore perhaps Holder was correct, shoot down the beast, and the greater good is affected- however does this make it ethically sound to slap them on the wrist for corporate manslaughter of children? Or how about the birth defects from Paxil? what amount of fines can atone that crime?

The full 7th amended complaint can be found here

Personally, I believe, these several hundred pages of exhibits were the tip of the iceberg, who knows how much more could have been unearthed?

There were thousands of reps with access to these kinds of documents, and thousands more in the company would have been aware, to some degree..

If any of them have a conscience, and are reading this, contact me (anonymously if you like) on: truthman30@gmail.com


The following are examples of exhibits (from Greg’s Complaint) detailing how GSK marketed their various products off-label illegally to doctors in the US.

GREGT

GREG2 GREG3 GREG5 GREG6  GREG11GREG3 GREG5 GREGone GREGseven GREGsix GREGten GREGtwo GREHfour

http://www.glaxowhistleblowers.com/settlement-agreement/

Glaxo’s settlement agreement and the government’s charges against Glaxo

The settlement agreement signed by GlaxoSmithKline, the federal government and the whistleblowers describes not only the terms of the settlement of the whistleblower cases but also the whistleblower claims the government supported based on its investigation.

The claims the government stated in the settlement agreement describing Glaxo’s off-label marketing of Wellbutrin, Advair, Lamictal, Zofran, Imitrex and Valtrex and the financial inducements Glaxo gave to doctors to convince them to prescribe those drugs were based largely on the qui tam lawsuit brought by Phillips & Cohen’s whistleblower clients.

For more information about the government’s claims and the settlement amount allocated to each drug, see the Glaxo settlement agreement for the whistleblower cases and the Justice Department fact sheet about Glaxo’s $3 billion settlement.

Below are the claims the government made in the settlement agreement about Glaxo’s off-label marketing of Wellbutrin, Advair, Lamictal, Zofran, Imitrex and Valtrex and financial inducements offered to doctors to prescribe those drugs. The settlement agreement also contains allegations involving Paxil, which were based on a separate whistleblower lawsuit.

  1. Wellbutrin: During the period January 1, 1999 through December 31, 2003, GSK knowingly: (a) promoted the sale and use of Wellbutrin for conditions (including weight loss, the treatment of obesity, sexual dysfunction and in combination with other antidepressants) and at dosages other than those for which its use was approved as safe and effective by the FDA, and some of which were not medically-accepted indications as defined by 42 U.S.C. §1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Wellbutrin; (b) made and/or disseminated unsubstantiated and/or false and/or misleading representations or statements about the safety and efficacy of Wellbutrin; and (c) offered and paid illegal remuneration to healthcare professionals to induce them to promote and prescribe Wellbutrin, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. ‘ 1320a-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Wellbutrin to be submitted to, or caused purchases by Medicaid and the other Federal Health Care Programs.
  2. Advair: During the period January 1, 2001 through June 30, 2010, GSK knowingly: (a) promoted the sale and use of Advair for conditions and dosing regimens other than those for which its use was approved as safe and effective by the FDA (including first line use for mild or all asthma, and for asthma previously treated by short-acting inhalers alone), and some of which were not medically-accepted indications as defined by 42 U.S.C. § 1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Advair (b) made and/or disseminated unsubstantiated and/or false and/or misleading representations or statements about the safety and efficacy of Advair (including that Advair was superior to the single component, inhaled corticosteroid alone, for patients previously treated by short-acting inhalers alone); and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Advair, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Advair to be submitted to, or caused purchases by Medicaid, Medicare and the other Federal Health Care Programs.
  3. Lamictal: During the period January 1, 1999 through December 31, 2003, GSK knowingly (a) promoted the sale and use of Lamictal for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including bi-polar depression, neuropathic pain, and various other mental diseases), and some of which were not medically-accepted indications as defined by 42 U.S.C. § 1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Lamictal; (b) made and/or disseminated unsubstantiated and/or false and/or misleading representations or statements about the safety and efficacy of Lamictal concerning the uses described in section (a) of this sub–paragraph; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Lamictal, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. §1320-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Lamictal to be submitted to, or caused purchases by Medicaid and the other Federal Health Care Programs.
  4. Zofran: During the period January 1, 2002 through December 31, 2004, GSK knowingly (a) promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea), and some of which were not medically-accepted indications as defined by 42 U.S.C.  § 1396r-8(k)(6) for which the United States and state Medicaid programs provided coverage for Zofran; (b) made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran concerning the uses described in section (a) of this sub-paragraph; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320-7b(b). As a result of the foregoing conduct, GSK knowingly caused false or fraudulent claims for Zofran to be submitted to, or caused purchases by Medicaid and the other Federal Health Care Programs.
  5. Imitrex, Lotronex, Flovent and Valtrex: From January 1999 through December 2004, GSK paid illegal remuneration for speaker programs, mentorships, preceptorships, journal clubs, advisory boards (including Local and Regional Advisory Boards and Special Issues Boards), Reprint Mastery Trainings, and provided gifts (including entertainment, cash, travel and meals) to health care professionals to induce them to promote and prescribe the drugs Imitrex, Lotronex, Flovent and Valtrex, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b). As a result of the foregoing conduct, GSK caused false claims to be submitted to Medicaid and certain other Federal Healthcare Programs.

http://www.justice.gov/sites/default/files/usao-ma/legacy/2012/10/09/Settlement_Fact_Sheet.pdf

Why so little on Paxil (Seroxat)?

Paxil1 Paxil2 Paxil3


http://www.theguardian.com/business/2012/jul/04/glaxcosmithkline-former-chair-3bn-us

GlaxoSmithKline: former chairman denies knowledge of $3bn US deal
Richard Sykes says pharmacy firm’s issues ‘complicated’, as FairPensions urges pursuit of executive malpractice
Sir Richard Sykes, ex-chairman GlaxoSmithKline
Sir Richard Sykes, former chair of GlaxoSmithKline, which has been criticised for ‘putting profits above ethics’. Photograph: Richard Saker

Terry Macalister

Wednesday 4 July 2012 19.54 BST
Last modified on Wednesday 1 October 2014 12.41 BST

Sir Richard Sykes, the former chairman of GlaxoSmithKline, has refused to criticise actions at the large pharmaceutical company, saying he had “not a clue” about the details of a $3bn settlement with US authorities.

But critics said the case, involving issues dating to 1997, underlined the need for tougher action, which could include certain executives being jailed.

FairPensions, the campaign for responsible investment, linked the GSK scandal to the firestorm that has engulfed Barclays bank in the past week, and said the controversies were costing the City much more than tougher regulation ever could.

Sykes, now chairman of the Royal Institution, and the UK’s largest NHS healthcare trust, said the issues concerning the pharmaceutical group, where he had been chairman, were “complicated” and he was still digesting the case, despite a corporate statement from GSK more than 36 hours earlier.

“I have not had a chance to read the newspapers and have not a clue as to what is going on,” he said, from his home in London. “It is a complicated situation with two different companies [SmithKline Beecham and Glaxo Wellcome] and they did not really start coming together till 2001.”

Sykes was chief executive of Glaxo before the £100bn merger in 2000 but then stood down as chairman of the combined GSK in the middle of 2002.

A whistleblower, Greg Thorpe, first alerted the company to the entertainment offered doctors and the culture that allegedly put profits above ethics in 2001.

Sykes suggested that the problems could have related mainly to SmithKline, prior to its merger with Glaxo.

But GSK insisted that the problem was in the US and in the past: “Since Andrew Witty became chief executive in 2008, GSK has made significant changes at all levels within the company to ensure we act with integrity in everything we do, and these matters do not reflect the company that we are today.”

The company admitted in its settlement with various American authorities that it had been offering lavish holidays and hospitality to targeted doctors and encouraged the prescription of unsuitable anti-depressants to children.

GSK also paid for articles to appear in medical journals lauding its products, and hired “independent” doctors to promote the treatments.

Thorpe raised his concerns with David Stout, who was then head of the US business, and Bob Ingram, GSK’s chief operating officer. When he was forced out of the company he took his case to the regulators, who spent almost 10 years investigating the issues.

Stout became a non-executive director of another London-listed pharmaceutical company, Shire plc, and Ingram is chairman of the biotech firm Elan Corporation.

Louise Rouse, director of engagement at FairPensions, said shareholders should be asking searching questions to ensure there is sufficient oversight of people and practices at the new companies the executives had joined.

“Even though the management has moved on, shareholders at GSK need to ensure that the root and branch reform promised on paper has in fact been carried out,” she said.

Sidney Wolfe, director of the Health Research Group at the Washington-based campaign group Public Citizen, noted that the latest fine on GSK was just the latest in a series dating back to 1991.

He said: “Until more meaningful penalties and the prospect of jail time for company heads who are responsible for such activity become commonplace, companies will continue defrauding the government and putting patients lives in danger.”



https://childhealthsafety.wordpress.com/2012/07/03/gsk-fined-us3-billion-largest-health-fraud-settlement-in-u-s-history/

GSK Fined US$3 BILLION – largest health fraud settlement in U.S. history

So hot on the heals of more fraud by Merck [Merck Vaccine Fraud – 2nd US Court Case Over MMR Vaccine] we now have more fraud by GlaxoSmithKline.  You can read the Associated Press breaking story here:

GlaxoSmithKline to pay $3 billion in fines, the largest health care fraud settlement in U.S. history – THE ASSOCIATED PRESS – Tuesday, July 3, 2012

The Justice Department said that British drugmaker will plead guilty to promoting popular antidepressants Paxil and Wellbutrin for unapproved uses. The company also will plead guilty to failing to report to the government for seven years some safety problems with diabetes drug Avandia, which was restricted in the U.S. and banned in Europe after it was found in 2007 to sharply increase the risks of heart attacks and congestive heart failure.

Instead of repeating the story we are going to set out the names of GSK’s Board and ask what they have done about this and also ask what is the next fraud to come out of the company? This is not the first time GSK has been mired in fraud.  We list below the Board of Directors of GlaxoSmithKline today – so check out who was on the board, read the following facts and then ask yourself “should they still be on GSK’s Board?” 

And don’t forget – what are we supposed to think of people like the GSK Board who hired James Murdoch of News International onto their Board of Directors to protect their reputation and then had to dump him because of all the corruption associated directly with James Murdoch at News Corporation and News International which is being examined publicly in the Leveson Inquiry.

And should British first ministers like Prime Minister David Cameron and Chancellor George Osborne cosy up to a company like GSK?  Should we as the public cross the street to avoid GSK and all who have anything to do with it?

And let us be clear about the dates – PA report:

The case against Glaxo was originally brought in January 2003 by two whistleblowers, former Glaxo sales representatives Greg Thorpe and Blair Hamrick. In January 2011, the federal government joined in the case.

BUT PA also report:

The company also will plead guilty to failing to report to the government for seven years some safety problems with diabetes drug Avandia, which was restricted in the U.S. and banned in Europe after it was found in 2007 to sharply increase the risks of heart attacks and congestive heart failure.

If 2008 is the cut-off date then is it the case that any current GSK Director on the Board prior to 2008 is one of those ultimately responsible for overseeing fraud – yes that’s right – fraud?

We can also justifiably ask, is 2008 the appropriate cut-off date or should it be October 2010 when the European Medicines Agency withdrew the licence for Avandia?  In other words the GSK Board of Directors as it was constituted up to and including October 2010 are all implicated as GSK was still marketing Avandia: European Medicines Agency experts have said Avandia, a leading diabetes drug, should be suspended from the market. BBC Health News 23 September 2010 Last updated at 17:13

As you can see of the 16 current GSK Board members, 10 were on the Board during and/or prior to 2008 and 11 up to October 2010.   So should these people be on the Board of any company?  And if not, what are they still doing there?  These are fair questions to ask.  After all, if they can let their companies get away with fraud then everyone might as well do the same.  And what did they know of these frauds?  And if they claim they knew nothing – then why are they on the Board of the Company in the first place.

PA reports: “Sir Andrew Witty, Glaxo’s CEO, expressed regret Monday and said the company has learned “from the mistakes that were made.”

It needs to learn more – like most of the Board of Directors should go and right now.  Here they are:

Sir Christopher Gent – joined the Board as Deputy Chairman in June 2004.

Sir Andrew Witty – Chief Executive Officer – joined the Board in January 2008.

Professor Sir Roy Anderson – joined the Board in February 2007

Dr Stephanie Burns – Non-Executive Director – joined the Board in February 2007.

Stacey Cartwright – Non-Executive Director joined the Board in April 2011.

Larry Culp – Non-Executive Director joined the Board in July 2003.

Sir Crispin Davis – Non-Executive Director joined the Board in July 2003.

Simon Dingemans – Chief Financial Officer joined the Board in January 2011.

Lynn Elsenhans – Chief Financial Officer joined the Board in July 2012.

Judy Lewent – Non-Executive Director joined the Board in April 2011. BUT She is the former Executive Vice President and Chief Financial Officer of Merck & Co., Inc. which is a corporation which has previously been found guilty of fraud.

Sir Deryck Maughan – Non-Executive Director joined the Board in June 2004.

Dr Daniel Podolsky – Non-Executive Director joined the Board in July 2006.

Dr Moncef Slaoui – Chairman, Research & Development joined the Board in May 2006.

Tom de Swaan – Non-Executive Director joined the Board in January 2006.

Jing Ulrich – Non-Executive Director joined the Board in July 2012.

Sir Robert Wilson – Non-Executive Director joined the Board in November 2003