Category: Wellbutrin

Sir Andrew Witty, Wellbutrin (Zyban/Bupropion) Marketing, And The Mystery Of Lauren Stevens…


Some very very interesting discoveries and posts on the way…

But for now…

These…

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http://www.docguide.com/glaxosmithkline-receives-first-european-approval-wellbutrin-xr-r-bupropion-hydrochloride-modified-re


Source: Blood  |  Posted 7 years ago

GlaxoSmithKline Receives First European Approval for Wellbutrin XR(R) (Bupropion Hydrochloride Modified-Release Tablets)

Marketing license granted in Netherlands for adult patients with depression

LONDON, UK — January 16, 2007 — GlaxoSmithKline announced today that Wellbutrin XR?* (bupropion hydrochloride modified-release tablets), has been granted a marketing license in The Netherlands for the treatment of adult patients with major depressive episodes. The medicine is also considered approvable by the regulatory agencies of 21 other countries** under the Decentralised Procedure.

Wellbutrin XR is the first once-daily noradrenaline dopamine reuptake inhibitor (NDRI) approved for the treatment of Major Depressive Disorder (MDD) in Europe. 1,2,3 Uniquely targeting dopamine and noradrenaline (two chemicals in the brain known to be involved in regulating mood) to treat MDD effectively, Wellbutrin XR offers an alternative to currently available treatments, including Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs) which some patients are unable to tolerate due to side effects such as weight gain and sexual dysfunction. 4,5,6,7

“Wellbutrin XR is an important new medicine for doctors and patients in Europe,” comments Andrew Witty, president, GSK Pharmaceuticals, Europe. “Depression can be a crippling condition that is often difficult to treat. With its unique mode of action, Wellbutrin XR offers a real alternative to the depressed patient. We hope its profile will help patients stay on their therapy, which would address a significant unmet need in the area of antidepressants.”

Wellbutrin XR is available as a 300mg or 150mg tablet with a dose of up to 300mg once daily starting with 150mg once daily.

Nearly 13 million patients have been treated with Wellbutrin XR in the USA where it is known as Wellbutrin XL *** and was FDA approved in 2003.5

It is expected that regulatory agencies in various European countries will grant national licenses for Wellbutrin XR throughout the first quarter of 2007, and the medicine could begin to be available to patients from April 2007.

GlaxoSmithKline has an agreement with Biovail Corporation for worldwide sales and distribution of bupropion hydrochloride modified-release tablets.

The most common side effects observed in clinical trials with Wellbutrin XR were trouble sleeping, headache, dry mouth, and upset stomach (nausea and vomiting).8

There is a risk of seizure with Wellbutrin XR, which increases with higher doses. People should not use it if they have had a seizure or eating disorder, or if they abruptly stop using alcohol or sedatives. People should not take Wellbutrin XR with monoamine oxidase inhibitors (MAOIs), or medicines that contain bupropion.

* Wellbutrin XR will be the most common tradename in European countries. Other tradenames include: Elontril (several countries), Voxra (Sweden) and Wellbutrin Retard (Norway).

** Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden.

*** While Wellbutrin XL is approved for the treatment of major depressive disorder in the United States, approved conditions of use and labeling may vary from those in European countries.

REFERENCES:
1. Stahl SM. Essential Psychopharmacology. 2nd ed. New York, NY: CambridgeUniversityPress; 2000.
2. Ascher JA et al. J Clin Psychiatry 1995; 56:395?401.
3. Stahl SM et al. Prim Care Companion J Clin Psychiatry 2004; 6:159?166.
4. Jefferson JW et al., J Clin Psychiatry 2006 June; 67(6):865-873.
5. GSK Data on file.
6. Thase ME et al. J Clin Pharmacol 2006; 26(5): 482-488.
7. Zajecka J. J Clin Psychiatry.2001; 62 Suppl 3:35-43.
8. GSK. Wellbutrin XR European Summary of Product Characteristics. 2007.

SOURCE: GlaxoSmithKline


http://adage.com/article/news/experience-pays-glaxo-wellcome-wins-consumers-pharmaceuticals-relationship-building-makes-difference/70483/

As direct-to-consumer prescription drug advertising continues to evolve, the No. 1 spender in DTC is evolving with it.

When the Food & Drug Administration relaxed its rules for prescription drug ads on TV in August, Glaxo Wellcome was ahead of the pack. Under the marketing stewardship of VP-General Manager of Marketing Andrew Witty, the company was first out of the gate with an estimated $10 million network TV buy for its antiviral Valtrex that mentioned both the drug’s name and herpes, the condition.

The spot also led viewers to print ads for full disclosure information.

SWIFT TO ACT

Glaxo’s swiftness was born of experience with DTC advertising and close contact with the FDA prior to the new rules.

“We started experimenting with DTC early and made a relationship with the rulemakers,” says Mr. Witty.

Indeed, Glaxo has been the top advertiser in DTC prescription drug advertising-a business expected to hit $1 billion this year-for two years running. Last year alone, Glaxo’s nasal spray Flonase received $32.7 million in support, migraine remedy Imitrex got $20.4 million, Serevent asthma inhaler had $16.4 million.

Mr. Witty also is adding more product firepower this year with Glaxo’s new anti-smoking pill Zyban getting an estimated $55 million in support (the brand is even getting TV teaser ads prior to its launch). Zithromax, the first antibiotic to receive DTC support, will get an estimated $15 million.

“Patients are demanding more information,” says Mr. Witty, 33. He notes that “one of the key challenges is getting patients to seek help and that’s where DTC comes in. Sometimes people need news, a sense of hope or courage-like with genital herpes-to go to their doctor.”

http://www.fiercepharma.com/story/glaxo-settles-multi-state-label-marketing-probe-105m-fine/2014-06-05

Glaxo settles multi-state off-label marketing probe with $105M fine

GlaxoSmithKline’s ($GSK) latest penalty for improper marketing practices may seem little more than a slap on the wrist–except that it’s coming at the worst possible time for the embattled British drugmaker. GSK agreed to pay $105 million to settle charges in California, New York, Texas and more than 40 other states that it illegally promoted its asthma drug Advair and antidepressants Wellbutrin and Paxil.

The states’ attorneys general alleged that GSK pushed mild asthma sufferers to request Advair even though the FDA did not approve it for mild cases, and that it marketed Wellbutrin and Paxil off-label for use in children.The states also claimed that the company promoted Wellbutrin for other unapproved uses.

Under the terms of the settlement, announced by Illinois attorney general Lisa Madigan, GSK has agreed to reform its marketing practices and refrain from disseminating information related to off-label uses of its drugs. GSK also agreed to continue for 5 years an internal program that “reduces the level of financial incentives by the company to drug sales representatives,” according to Madigan’s statement.


GlaxoSmithKline Anonymous board for GlaxoSmithKline

http://www.cafepharma.com/boards/showthread.php?t=465348

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#1
Old 05-10-2011, 02:24 PM
Anonymous

Posts: n/a

Today the Bush appointed pro-corporation Judge Titus, dismissed the Charges against Lauren Stevens. He will be regreting his foolish actions at a later date. Clear case of Judicial prejudice and malpractice. Wait until he finds out how this company raped the taxpayers and injured/killed patients.

The good news is that according to the company the main investigation on all 9 main GSK drugs is in Boston. If I am correct the DOJ criminal attorney there is Susan Winkler, she is a pit bull.
Stevens will now be indicted on the main crimes she committed including coverup of illegal activities, payments of kickbacks to physicians and a vast conspiracy of off label detailing that included 9 drugs, all under her watch. She will be indicted this time, the Judge in Boston is legitimate, put it that way.

It was definitely proven at the trial that GSK knowingly did two things….and these were with all the drugs.

1) They detailed off label…just look at all the call reports, which Stan Hull later did away with, and ALL the Wellbutrin, Paxil, Imitrex, Lamictal, Valtrex etc. They covered up everything and it goes all the way to the top.

2) They paid kickbacks and gave quid pro quos to some 49,000 speakers on the speakers bureau. We saw it all.

This was a narrow case on one small subject, hiding Wellbutrin slides from 2 Docs, What about the other thousands that had the same slides. Also,what about all the off label slides for other drugs. I saved all those, call me.

When there is a trial in Boston, there will be criminal and civil convictions. The company will be barred from all Federal programs, and if the appropriate penalties apply will be bankrupt.

Tell all the mothers who have deformed babies, or children that killed themselves with Paxil and other drugs. The Judge did not know of that misconduct, which is huge. He will be proven the fool that he is, and a disgrace to the bench, and it does not end there.

In the meantime, according to GSK attorneys who illegally broadcast an FCA case on their website, for profit-we know who you are,…and GSK who admits there is an 8 year investigation ongoing in Boston….hold on to your seatbelts, this company is in for a crash landing.

Hopefully soon.

Old 05-13-2011, 09:21 PM
Anonymous
Posts: n/a
Lightbulb Re: Great news on Stevens trial

They also showed CEO Witty was in on marketing sscams in the late 90’s and had to lie and coverup.How Much do you think they paid the same speakers when he was there ? Sorry Witty, also big mistake paying of Ingram to be you Advisor in chief in Jan 2010. Corrupt to the core and in on it all. Pretty disgusting, but as stated before Justice will prevail in spite of this small FDA case that would have gone against Stevens, unless she had a uniformed fool for a Judge who will regret how he hurt patients and taxpayers. Recall the SOB, fools like that do not belong making decisions for juries…especially the THIRD jury. The prosecutor in the case Sara Bloom is a patriot..Titus is a corrupt fool.

Oh and did you notice they shot the messenger, fired them after they came forward with slides and named all the off label crap going on -9 drugs, they say beginning in Co.- now in Mass.—-Titus is an embarrasment to the bench. It will be proven.

Political hack. End of story (for now).

Old 05-13-2011, 09:21 PM
Anonymous
Posts: n/a
Lightbulb Re: Great news on Stevens trial

They also showed CEO Witty was in on marketing sscams in the late 90’s and had to lie and coverup.How Much do you think they paid the same speakers when he was there ? Sorry Witty, also big mistake paying of Ingram to be you Advisor in chief in Jan 2010. Corrupt to the core and in on it all. Pretty disgusting, but as stated before Justice will prevail in spite of this small FDA case that would have gone against Stevens, unless she had a uniformed fool for a Judge who will regret how he hurt patients and taxpayers. Recall the SOB, fools like that do not belong making decisions for juries…especially the THIRD jury. The prosecutor in the case Sara Bloom is a patriot..Titus is a corrupt fool.

Oh and did you notice they shot the messenger, fired them after they came forward with slides and named all the off label crap going on -9 drugs, they say beginning in Co.- now in Mass.—-Titus is an embarrasment to the bench. It will be proven.

Political hack. End of story (for now).

View Full Version : Trial not just about weight loss-this involves

Anonymous
04-28-2011, 12:45 PM
The active detailiing of Wellbutrin to pregnant women (birth defects), the detailing of Wellbutrin for kids, ADHD, bipolar, anxiety and more with death and/oer damaging results. The waste of Medicare dollars as an ‘impotency’ drug for all men and women. The paying of kickbacks to thousands of physicians to lecture off label at luxurious resorts. The weight loss portion is small, Stevens knows that and so does everyone else at GSK. We were trained and had to pass a test on weight loss in non depressed patients. Stevens is a fucking criminal in on much more than taking the bullet for GSK. Just wait

4. Feds: Ex-GSK lawyer put loyalty above law
By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

Former GlaxoSmithKline attorney Lauren Stevens didn’t get much of a reprieve after her first indictment was tossed out last month. The government quickly indicted her again–on obstruction charges, among others–and, starting yesterday, took their case to trial.

Justice Department lawyers say Stevens tried to cover up potential marketing violations at GSK. When government investigators came calling, she responded by making false statements about the company’s promotions of the antidepressant Wellbutrin, they maintain. She also failed to disclose some questionable marketing practices and didn’t turn over potentially incriminating promotional materials, the indictment says.

“This is a case about a lawyer who put loyalty to her company above fidelity to the truth and to the law,” prosecutor Patrick Jasperse said during opening statements in a Maryland federal court (as quoted by Bloomberg). “This is a case about a lawyer who went too far, from aggressively representing her company to breaking the law.”

Stevens’ attorney told the jury she didn’t intend to mislead the FDA about Wellbutrin marketing. She responded to the investigation as advised by in-house counsel at GSK and by outside law firm King & Spalding, attorney Reid Weingarten said. “Everything she did in this case was utterly inconsistent with an intent to deceive the government,” he said.

Anonymous
04-29-2011, 07:07 AM
If you have something, become a whistle blower. What classes did you ever take and what test? No such thing. It’s obvious you hate GSK. No one I know promoted Wellbutrin for weight loss. A good friend of mine is an MD that owns a comprehensive weight management practice. The only time he ever used any antidepresseants were when patients exhibited signs and symptoms of depression or disthymia. Hire a lawyer and grind your axe in court if you really have something.

The active detailiing of Wellbutrin to pregnant women (birth defects), the detailing of Wellbutrin for kids, ADHD, bipolar, anxiety and more with death and/oer damaging results. The waste of Medicare dollars as an ‘impotency’ drug for all men and women. The paying of kickbacks to thousands of physicians to lecture off label at luxurious resorts. The weight loss portion is small, Stevens knows that and so does everyone else at GSK. We were trained and had to pass a test on weight loss in non depressed patients. Stevens is a fucking criminal in on much more than taking the bullet for GSK. Just wait

4. Feds: Ex-GSK lawyer put loyalty above law
By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

Former GlaxoSmithKline attorney Lauren Stevens didn’t get much of a reprieve after her first indictment was tossed out last month. The government quickly indicted her again–on obstruction charges, among others–and, starting yesterday, took their case to trial.

Justice Department lawyers say Stevens tried to cover up potential marketing violations at GSK. When government investigators came calling, she responded by making false statements about the company’s promotions of the antidepressant Wellbutrin, they maintain. She also failed to disclose some questionable marketing practices and didn’t turn over potentially incriminating promotional materials, the indictment says.

“This is a case about a lawyer who put loyalty to her company above fidelity to the truth and to the law,” prosecutor Patrick Jasperse said during opening statements in a Maryland federal court (as quoted by Bloomberg). “This is a case about a lawyer who went too far, from aggressively representing her company to breaking the law.”

Stevens’ attorney told the jury she didn’t intend to mislead the FDA about Wellbutrin marketing. She responded to the investigation as advised by in-house counsel at GSK and by outside law firm King & Spalding, attorney Reid Weingarten said. “Everything she did in this case was utterly inconsistent with an intent to deceive the government,” he said.

Anonymous
04-29-2011, 07:51 AM
Now there is some good advice and a lot of bullshit combined. Now, who would want to give up ten years of their life to blow the whistle ? Maybe someone with some balls and brains, unlike your lame ass.
Anonymous
04-29-2011, 10:57 AM
If you have something, become a whistle blower. What classes did you ever take and what test? No such thing. It’s obvious you hate GSK. No one I know promoted Wellbutrin for weight loss. A good friend of mine is an MD that owns a comprehensive weight management practice. The only time he ever used any antidepresseants were when patients exhibited signs and symptoms of depression or disthymia. Hire a lawyer and grind your axe in court if you really have something.

I sold Wellbutrin for years and often sold on the pregnancy category B as well as the weight loss. Also sold a ton on the combination use with an SSRI. None of these were approved messages from marketing but there is only so much you can do with “no sexual side effects.”

When you are threatened monthly with being fired for not pulling up numbers on a drug with no formulary coverage (b/c GSK was selling the generic SR for pennies)- you have to get creative to protect your job so you can feed your family.

Anonymous
04-29-2011, 11:42 AM
I sold Wellbutrin for years and often sold on the pregnancy category B as well as the weight loss. Also sold a ton on the combination use with an SSRI. None of these were approved messages from marketing but there is only so much you can do with “no sexual side effects.”

When you are threatened monthly with being fired for not pulling up numbers on a drug with no formulary coverage (b/c GSK was selling the generic SR for pennies)- you have to get creative to protect your job so you can feed your family.

Everybody did that and more, it was however a marketing plan. We were trained on weight loss in nondepressed patients…tested on studies, Why ? Every DM that rode with reps heard all the off label promotion, they all including marketing and upper level managers saw the call reports…then they went to Write Right (lie on call reports) Simple. Fax backs were a contest to see how many we could get out, whether the doc asked for them or not. Most reps carried copies in their bags, the ones without the not to be used for detailing, which we all got by simply calling in. These were plans by marketing, PRIDE programs and whore speakers were utilized by all to sell of label. Hudziak, Pradko, Montano, and hundreds of others were booked months in advance with off label slides printed by GSK. Are you shitting me ? Getting creative ? everyone was then creative because it was the marketing plan, it was a return on investment with some 50,000m speakers. If they didnot say what they were told, they were dropped. You think you were some kind of rogue rep huh ? LOL