The Death of Elisa Lam

21-year-old Elisa Lam

This is a blog about the bizarre case of 21-year-old Elisa Lam, a Canadian student at the University of British Columbia in Vancouver, whose body was recovered from a water tank atop the Cecil Hotel in Downtown Los Angeles on February 19, 2013.

Many readers may have already seen the related YouTube video which was released by the LAPD. It has gone viral with over 24 million views.

In the footage, below, Lam is seen exiting and re-entering the elevator, talking and gesturing in the hallway outside, and sometimes seeming to hide within the elevator, which itself appears to be malfunctioning. Her actions caught on CCTV prompted many theories about her disappearance and death which include speculations that she was either murdered, died by suicide, or experienced some sort of paranormal activity.

The LAPD was contacted by Lam's parents from their Vancouver home. After an investigation into her whereabouts revealed nothing, the police issued a Missing Person's poster (Fig 1)

(Fig 1)

Here's the CCTV footage

Sometime after the LAPD publicly released the video, guests at the Cecil Hotel had complained about low water pressure and that the water was black. Upon investigation of the rooftop tanks, Lam's body was found naked with her clothes floating next to her.

Two days later the Los Angeles coroner's office issued a finding of accidental drowning, with bipolar disorder as a significant factor. In June of the same year, a full coroner's report was released. This is where we, for the first time, have access to Lam's toxicology report. The full report lists Lam's death as an "accident."

Before reading it, it's interesting to note that days prior to her death, Lam was room sharing at the hotel. The other two roommates complained to hotel management that Lam's behaviour was "odd". Lam was then moved to a room on her own.

Here's the toxicology report that piqued my interest. (Click on images to enlarge)

As you can see, Lam was medicated with Wellbutrin, Lamictal, Seroquel and Effexor, four potent psychiatric drugs. Four drugs, when taken together, throw up major interactions, as seen here.

Given Wellbutrin, Effexor and Lamictal were found in her system (Fig 2), a logical question is did Lam abruptly stop taking Seroquel?

Tiffany Hahn, a licensed Private Investigator in the State of California, raises a very important question about this. She writes, "Elisa Lam has a prescription for Quetiapine. The Quetiapine was prescribed by Dr. Sarah E. Scarfe and filled at London Drugs (Canadian Pharmacy), 604-570-0252, Prescription Number: 7153992; Prescribed 01/11/2013. She was issued 30 tablets. There were still 20 in the bottle. RX Directions: 2 Tabs QHS PRN (QHS = Abbreviation for L. quaque hora somni, every bedtime; PRN: Abbreviation meaning “when necessary”).

If there are 10 tablets missing from the bottle, Elisa Lam might have taken them in the 21 days between when they were prescribed (January 11, 2013) and her disappearance (February 1, 2013)."

Keywords here, "When necessary". So, one at bedtime and one whenever she felt like it. What Dr would advise a patient to take Seroquel "when necessary"? Doubling a dose and then halving a dose abruptly can have dire consequences for the patient. We can see that she didn't take one every night as only 10 were missing from her bottle. Missing doses like this can cause an array of problems. The patient information leaflet for Seroquel states: "If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten tablet."

Why then did her prescribing psychiatrist tell her to take one at bedtime and one  "when necessary" This would, in essence, be doubling her dose, would it not?

Fig 2

One has to ask why a 21-year-old woman had been prescribed these four drugs given their major interactions when combined. We can see from the report that her prescriber was Dr. Sarah Scarfe, a Psychiatrist who practices at Student Health Services Psychiatry, University of British Columbia, M334-2211 Wesbrook Mall, Vancouver, Canada.

On top of this, it is alleged that Lam also made posts on her blog referring to her Hypomania and depression. She also made a post where she detailed making an appointment with a doctor to discuss Electroconvulsive Therapy.

According to some prescribers, "bipolar disorder" may include psychotic episodes. However if, indeed, Lam was suffering "bipolar disorder", why would her condition cause psychosis and suicidal thinking? Aren't the drugs she was given supposed to effectively treat such things?

Let's look at the four prescription drugs, three of which, were found in her system (Effexor, Lamictal and Wellbutrin)

Wellbutrin - norepinephrine-dopamine reuptake inhibitor (NDRI) (GlaxoSmithKline)

The website VerywellMind tells us, "Antidepressants, including Wellbutrin, are widely used in managing depression in bipolar disorder. There are concerns when it comes to antidepressants and bipolar disease. One of these concerns is called phase switching, which is a shift in mood from depression to mania. This can be a serious problem because mania can result in impulsive or dangerous behavior."

It is used “off-label” to treat bipolar.

Wellbutrin carries a suicide risk on the patient information leaflet. It also carries a warning of akathisia, a condition which is best described as an 'inner restlessness and turmoil' that can become so overwhelming that death is a welcome result.

Lamictal - Antiepileptic (GlaxoSmithKline)

Lamictal was originally developed as an anticonvulsant to treat seizures and is often used with other medications in the treatment of bipolar.

In 2009, the FDA forced manufacturers of all antiepileptic drugs to include new warnings of possible suicide ideation.

The current Lamictal patient information leaflet carries a suicide warning. Akathisia is also listed as a side-effect.

Seroquel - Antipsychotic - AstraZeneca

Seroquel was approved in 2006 for the treatment of depressive episodes in patients diagnosed with bipolar disorder. It carries a suicide risk warning on the patient information leaflet. People taking Seroquel have a 30% to 40% chance of akathisia.

Seroquel has been the subject of more than 25,000 product liability lawsuits, including one brought by federal prosecutors. The federal litigation and other lawsuits alleged that AstraZeneca (Seroquel's manufacturer) did not disclose certain side effects of the drug, and encouraged doctors to prescribe the drug for treatments not approved by the U.S. Food and Drug Administration (FDA).

Effexor - serotonin-norepinephrine reuptake inhibitor (SNRI) - was introduced by Wyeth Pharmaceuticals in 1993. Since 2009, it has been marketed by Pfizer

Not indicated for bipolar, however, according to Psycom.net, "If you have bipolar disorder and take an SNRI, you may be at risk for triggering a manic episode."

In addition to birth defect lawsuits, other claims have been made for suicidal thoughts, violent behaviours and discontinuation syndrome, or on behalf of deceased loved ones. 

Effexor carries a suicide warning on its patient information leaflet. Akathisia is also listed as a side-effect.

Four drugs that carry suicide warnings, four drugs prescribed to this 21-year old woman by a psychiatrist, Dr. Scarfe, who works at a university that caters to young people ages 25 and under. The FDA's black box suicide warning for people age 25 and under was supposedly created to help teens and young adults be better informed about critical adverse drug effects. It is not clear whether Dr. Scarfe ever provided informed consent to Elisa. Many psychiatrists fail to provide informed consent and leave it to chance that a young person such as Elisa, would, somehow, automatically know to carefully read the microscopic fine print in each of the four drug leaflets.

Maybe bipolar disorder was a significant factor in this young woman's suicide or maybe, just maybe, the four drugs found in her system, all of which carry suicide warnings, contributed to her obvious psychosis as depicted in the CCTV footage and previous bizarre behaviour with roommates at the Cecil Hotel in Downtown Los Angeles.

In September 2013, Lam's parents, David and Yinna Lam, filed a wrongful death suit, claiming the hotel failed to "inspect and seek out hazards in the hotel that presented an unreasonable risk of danger to Lam. In 2015, the suit was dismissed.

Maybe they would have had better luck filing suit against Lam's psychiatrist given the four drugs Lam was prescribed, three of which were in her system at the time of her increasingly "odd" behaviours and sudden death.

Bob Fiddaman

Elisa's full autopsy report

Learn more about akathisia here

Guess Who's Being Sued Again?

Drug: Lamictal (lamotrigine)
Marketed and manufactured by GlaxoSmithKline.

According to the Daily Mail, the lawsuit, filed by Khaliah Shaw, 26, alleges that within a month of taking the drug, she had developed a rash on her face, while the skin on her lips had started to peel off. Although she visited her local ER, she was initially diagnosed with the flu.

Two days later, it is claimed, Miss Shaw woke up in excruciating pain, with the skin on her face, neck, back and chest falling off and her mouth covered in blisters.

The reaction left her skin permanently scarred, and she is slowly losing her sight.

Shaw, along with many others, are suing GlaxoSmithKline for promoting the product without warning of the risks, claiming more than $3.45 million in medical costs.

Shaw lost up to 90 percent of her skin.

More articles...

Woman's skin burned from inside out after dosage error, lawsuit claims

Wrong Treatment Melts Woman’s Skin Inside Out

Student, 26, who was almost blinded and lost 90% of her skin after taking common anti-seizure drug sues GlaxoSmithKline for more than $3 million


The GSK company mission statement is to, "help people do more, feel better, live longer."

Bob Fiddaman

What GSK Told Reps to do.

The following video is for the UK Serious Fraud Office (SFO) who announced last month that they will be investigating GlaxoSmithKline.

It's assumed that the SFO will only be investigating Glaxo's foreign bribery allegations and won't be delving into any alleged bribery or fraud committed in the UK.

If the SFO think that Glaxo's UK practices are whiter than white then they really should take some time out to watch this video.

Blair Hamrick was one of the whistleblowers that blew the lid on Glaxo's off-label promotion of drugs and also how they bribed US doctor's to prescribe Glaxo's drugs.

All the SFO have to do is what I did. They need to put Glaxo UK in the spotlight and ask them if their sales team, including senior management and reps, paid doctors, hospital officials and health institutions to use GSK products in the UK, resulting in the "illegal revenue" of hundreds of millions of British pounds. Or if they, as a company, ever bribed UK government officials?

If GSK answer 'No' then the SFO can do one of two things.

1. Believe them

2. Investigate to see if they are telling the truth.


Here's the video.




Related stories.

A Message From the UK Serious Fraud Office re GSK

Cronyism, Chinese Style

GlaxoSmithKline: The Andrew Witty "Era"

Advair Launch 2001: GSK's “Myth of Mild” Campaign


Bob Fiddaman

Email to Editor of JAACAP - Re Paxil 329

Below is an email I've sent to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP]

It follows on from the recent abhorrent behaviour of British pharmaceutical company, GlaxoSmithKline and their agreement to plead guilty with regard to the way they knowingly misbranded Paxil and knowingly falsified a ghostwritten study [329] for the sole purpose of making money from a product that had a propensity to induce suicide in children and adolescents.

A call for this fraudulent study to be retracted has previously been asked for by Jon N. Jureidini and Leemon B. McHenry, whom are both mentioned and referenced below.

I've previously called for Glaxo CEO, Andrew Witty, to contact JAACAP, seeing how it was his company that hired a ghostwriter for the article.

His limp-wristed excuse that this was part of an era just doesn't wash. If he had any morals then he would tell the journal to pull the study, although the damage has been done now and many children may have died as a result of this study being published.

More about Witty coming soon on this blog... there's some disgruntled whistleblowers out there.

Anyway, here's the email to the editor of the Journal of the American Academy of Child and Adolescent Psychiatry.


Dear Mr Martin,

I am the author of the book, The evidence, however, is clear; the Seroxat scandal, and the blog, Seroxat Sufferers. Seroxat is the UK brand name for GlaxoSmithKline's antidepressant, you will know it by its US brand name, Paxil.

The reason I am contacting you is with regard to the publication in the Journal of the American Academy of Child and Adolescent Psychiatry entitled, "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al.

It is my understanding that the particular study was used as a marketing tool by British pharmaceutical giants, GlaxoSmithKline, and was in fact not written by the authors, Martin Keller et al, at all but by Sally Laden, an editorial director for Scientific Therapeutics Information.

Given that this publication has been widely available since 2001 its safe to assume that many inquiring doctors, pediatrics, child psychiatrists and, in general, healthcare professionals, have used it as a guide when making a decision whether or not to prescribe Paxil off-label to children and adolescents.

It is also my understanding that the study, better known as Paxil 329, has been brought to your attention in the past by Jon N. Jureidini and Leemon B. McHenry and despite pointing out to you Paxil 329'S flaws you refused to retract it. In fact, you added that, “We have found no evidence for such errors nor any justification for retraction according to current editorial standards and scientific publication guidelines. We therefore will not proceed further with your request” [1]

I am sure you are aware of recent events regarding GlaxoSmithKline's guilty plea surrounding the illegal marketing and promotion of many of their products, one of which was Paxil.

Glaxo agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C.  331(a), 333(a)(1) & 352(a). That 'misbranded drug' was Paxil.

Transcripts of GSK's plea and settlement agreements are available on the Department of Justice website. [2]

Regarding Paxil and their guilty plea, Glaxo settled allegations that:

From 1999 to 2003, during sales calls, dinner meetings, spa programs, lavish weekend conferences to places such as Puerto Rico and Hawaii, through a false and misleading medical journal article, and through the distribution of free samples for patient use, GSK promoted Paxil to doctors for the treatment of depression and, to a lesser extent, obsessive-compulsive disorder in patients under age 18.

and

That they conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, GSK failed to demonstrate efficacy on the endpoints identified in the study protocols.

and

That they hired a contractor to write an article on one of the studies that was published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). The article stated that Paxil “is generally well tolerated and effective for major depression in adolescents.” The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol.

and

There marketing team distributed the JAACAP article to all of the Paxil sales representatives with a cover memo that stated that Paxil had demonstrated “REMARKABLE Efficacy and Safety in the treatment of adolescent depression.” Some GSK sales representatives used the article to urge doctors to prescribe Paxil to treat patients under age 18.

Given that they have pleaded guilty one would assume that the next natural step would be for the study to be retracted. I gather the responsibility falls upon you to issue such an order.

Can you tell me if you plan to retract "A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression." - Martin Keller et al, and/or issue an explanation as to why you wish to retract it?

If you plan not to retract it could you please explain why?

Could you please also state, for the record, that your position is that you can still see no evidence of errors nor any justification for retraction according to current editorial standards and scientific publication guidelines.

Meantime, I look forward to your reply and hope that you will find it in your heart to remove this fraudulent publication as a goodwill gesture to the parents of children that have killed themselves as a result of Paxil induced suicide after it was prescribed to them by doctor's, pediatrics, child psychiatrists and, in general, healthcare professionals, whom used your journal as a reference when weighing up their decisions to prescribe it to this vulnerable population.

Yours sincerely,

Bob Fiddaman.

[1] Jureidini, Jon N. and McHenry, Leemon B.(2011) 'Conflicted Medical Journals and the Failure of Trust', Accountability in Research, 18: 1, 45 — 54
[2] Department of Justice - GLAXOSMITHKLINE SETTLEMENT FACT SHEET - http://www.justice.gov/usao/ma/news/GlaxoSmithKline/Settlement_Fact_Sheet.pdf







Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Glaxo's Andrew Witty and Paxil 329

Two recent articles grabbed my attention of late, both are brilliantly written, both drag up the Paxil 329 study once more.

Jonathan Leo, Ph.D. - wrote, 'Study 329′s Authors: Should Those Who Live in Glass Houses Throw Stones?' Whilst Paul Basken penned, 'Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement'

Both are well worth the read.

Both got me thinking.

With Glaxo Chief, Andrew Witty, blaming everyone but himself for the abhorrent way his company, GSK, hid the Paxil suicide link in children I can only assume that the fraudulent marketing by his company would be something he wants to obliterate from his company.

There have been calls for the academics involved in the shameful Paxil 329 study to be criminally prosecuted. The study, headed by child psychiatrist, Martin Keller, was actually written by Glaxo. Keller, along with other key opinion leaders, added their names to the paper to make it look like they had each played a part in testing the safety of Paxil in kids. Truth is, they didn't.

Truth is Paxil wasn't safe for children to take.

Keller and the rest of the 'experts' have to live with that.

The study itself was, after being passed around for three years between child psychiatrists, lawyers and PR firms, published in 2001 by the Journal of the American Academy of Child and Adolescent Psychiatry. Calls for it to be removed/retracted have been ignored by the journal.

Now, if Glaxo chief, Andrew Witty, had indeed been ashamed by his company's recent $3 billion payout for illegally promoted, among other drugs, Paxil, then surely it's down to him to contact the Journal of the American Academy of Child and Adolescent Psychiatry to ask them to retract the offending fraudulent study?

I'd like to give Witty a helping hand here. His company, Glaxo, haven't really done anything to help me or the  thousands of others wean off their addictive Paxil but, hey, you don't give to receive, right?

With this in mind I've devised a letter for Witty to simply sign and send off to the American Academy of Child and Adolescent Psychiatry.

All you have to do is sign it Witty. [Just print off and send to the journal, there's a good chap.]

For those, like me, who can't read small print, here's the letter in full:

Sir Andrew Witty

GlaxoSmithKline

980 GreatWest Road

Brentford

Middlesex

TW8 9GS

Dear, Journal of the American Academy of Child and Adolescent Psychiatry,

It is with great regret that I have to report that a study, A Multi-center, Double-blind, Placebo Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression- Acute Phase, sent to you under the guise of many highly thought of and influential psychiatrists, is actually false and misleading and could potentially cause harm to the patient population it was supposed to protect... children and adolescents.

The company I am now chief executive of, GlaxoSmithKline, have recently plead guilty and paid $3 billion as part of this criminal and civil resolution. 

We agreed to plead guilty to three misdemeanor violations of the Food, Drug and Cosmetic Act.

Regarding Paxil, we agreed to plead guilty to distribution of a misbranded drug due to false and misleading labeling, we also agreed to plead guilty to distribution of a misbranded drug due to inadequate directions for use, that drug was called Wellbutrin, you may know it as Zyban, that's down to me and my former role as VP Manager back in 1997... those were the days. Anyway, I digress, we also agreed to plead guilty to failure to report data to the FDA the adverse effects our diabetes drug, Avandia, was having on people. I heard a ripple that some folk died whilst taking this drug but I don't believe in anecdotal reports.

Anyway, back to the study.

We conducted three placebo-controlled clinical studies to study Paxil’s safety and efficacy in treating depression in patients under age 18. In all three studies, we failed to demonstrate efficacy on the endpoints identified in the study protocols.

Because of this we hired a contractor to write an article on one of the studies [329] that was published in July 2001 in your journal.

The article stated that Paxil "is generally well tolerated and effective for major depression in adolescents." The article did not explicitly state that the study failed to demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints that had been identified in the study protocol. We kind of thought that if we would have mentioned that it had failed  demonstrate efficacy on either of its two primary endpoints or on any of the secondary endpoints then we would not have been able to have a fair fight with Eli Lilly, who, at the time, were winning the antidepressant war with their particular poison, Prozac.

The study that our article referred to wasn't in fact written by any of the names that appear on it, namely, Martin B. Keller,  Neal D. Ryan, Michael Strober, Rachel G. Klein, Stan P. Kutcher, Boris Birmaher, Owen R. Hagino, Harold Koplewicz, Gabrielle A. Carlson, Gregory N. Clarke, Graham J. Emslie, David Feinberg, Barbara Geller, Vivek Kusumakar, George Papatheodorou, William H. Sack, Michael Sweeney, Karen Dineen Wagner, Elizabeth B. Weller, Nancy C. Winters, Rosemary Oakes, and James P. McCafferty.

I realize that by coming clean on this I am bringing into dispute the names of those above, who, for years, have all claimed that they played a part in the study. In fact the whole thing was drafted by Sally Laden, an editorial director for Scientific Therapeutics Information. You may have already seen the leaked memo from my company that sees the apparent lead author of the study, Martin Keller, write to Sally with, "Dear Sally, You did a superb job with this. ... It is excellent. Enclosed are rather minor changes from me."

As you may be aware, Martin Keller, or Marty as I like to call him, has gone on to earn vast amounts of money sitting on Advisory Boards for various pharmaceutical companies who want their antidepressants given that golden hallmark. Many others in the list have faced the wrath of a growing army of patient advocates/bloggers too. Poor old Stan Kutcher took a hammering a while back and subsequently failed to get elected in Novia Scotia, Canada. Karen Wagner seems to be doing well, although I understand she's under close scrutiny for a paper she wrote [ahem] about the safety of another antidepressant apparently being safe for kids, despite a previous study claiming that it wasn't. Neal Ryan made himself look rather silly when he was confronted by that Scottish bint, Shelley Jofre, from the BBC whilst the others have been pretty good at deflecting questions about their role in writing our study.

Many children have died by suicide whilst taking our drug, Paxil, many of whom should have been protected by us as we, as a caring company, had a duty to protect the most vulnerable. Alas, we failed and we failed on a huge scale.

Well, it's time to push that era away and to start making amends. So please could you retract the Paxil study from your journal and maybe offer an apology on my part for all the kids that have died since its publication. Although we can't say for sure that they carried out killing themselves because they were taking our drug, we still can't rule it out.

Sorry for any inconvenience this may cause you but I'm turning over a new leaf to get the public believing in GlaxoSmithKline again. I'm even going to blow the lid on my own past as VP Marketing Manager, that's if that pesky whistleblower, Greg Thorpe, doesn't beat me to it.

I hope to hear from you soon.

Please remember to to do more, feel better and live longer.

Yours sincerely,

Sir Andrew Witty

{SIGN HERE}

Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

Greg Thorpe GSK Whistleblower and the 'Dark Knight'

GSK's Andrew Witty. What was his role in 1997/98?

One of the recent UK GSK whistleblowers, Greg Thorpe, is letting off some steam on a UK newspaper website.

I'm trying to reach out to Greg for an interview for this blog. He, it appears, has much to say about Sir Andrew Witty, CEO of GlaxoSmithKline, in the comment section of the Yorkshire Post article, "Glaxo admits ‘mistakes’ over US guilt"

Just in case Glaxo's highly paid lawyers feel the need to put pressure on the Yorkshire Post, I have added Greg's comments below:


Someone over there ask Sir Witty, VP in marketing at the same time, app. 1997-2000, what his role was in all this blood money. He calls it echoes of the past, another era, another company yet he was there. Did he participate ? Did he know ? What did he know ? Why did he not come forward ? Why won't he answer these questions, seems logical....whether he was involved or not. I blew the whistle, I was tossed out after 24 years with the company.


I was terminated and retaliated against for the last 11 years. The law demands that GSK pay double back pay, reinstate me..or pay front pay, plus pay for the horrors they have put me and my family through for the last 10 plus years. GSK covered up their conduct, got caught and now Witty is "sorry" ? Yes, actions speak louder than words.....this "changed" company, who should reward me for coming forward to them with the marketing schemes, now wish to use their "blood money", to deny me my rightful compensation. They took 11 years from me and my family suffered. I was blackballed in the pharmaceutical business. In the meantime Witty was "knighted". Well Sir Witty, now you are making me fight you in Court for what you owe me. GSK is huge, but you will not break me. So from now on, when you say you are sorry, tell the whole story, not just your filtered version. Appoint me as your compliance officer, I am well qualified....No GSK has not changed, they intend on shooting the real messenger that tried to change the company.....again. Nice try Sir Witty, tell the whole story the next chance you get...Sincerely Thorpe the "commoner".


----



Oh yes, and you Britts must read my Complaint, and see the exhibits, you can find it online...Thorpe v. GlaxoSmithKline.
Quite the story...3 billion dollars, hmmmm.


----



Oh and Sir Witty, where does the buck stop, the charges went all the way until 2010, You were CEO , "ECHOES OF THE PAST ? '".....Then your thousands of attorneys, here in the states, threw Avandia into the settlement.Nobody knows how many thousands died from that drug.


Avandia killed my own mother, do you want her picture, her medical records, or maybe some of her ashes, a reminder every day that when you hide clinical data, someone dies.....she is one of thousands. Who is going to jail ....any recommendations, SIR Witty ?


Your attorneys sneaked that drug into the settlement without my knowledge. A scam period, my own mothers life was worth a thousand times the small amount you paid on that. You are "sorry", well maybe a little hard time in a U.S. prison would clear your conscience. I am sure your cellmate, BUBBA will turn your "knighthood" into the "knightmare", your changed squeaky clean company, GSK deserves. A knight ? Please.


----

Back story about GSK's Knight HERE.

Greg, if you are reading... let's Skype.

GlaxoSmithKline: The Andrew Witty "Era"

GSK's Andrew Witty. What was his role in 1997/98?

First off let's take a look at Andrew Witty's statement that came on the back of his company pleading guilty to violations over a number of its drugs.

“Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.

“We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organisation and displaying integrity in everything we do.

 “In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct. In the last two years, we have reformed the basis on which we pay our sales representatives and we have enhanced our ability to ‘claw back’ remuneration of our senior management. 

 “We have a vital role to play in bringing innovative medicines to patients and we understand how important it is that our medicines are appropriately promoted to healthcare professionals and that we adhere to the standards rightly expected by the US Government.”

All seems 'sweet' until we delve deep into Andrew Witty's tenure at Glaxo Wellcome and GlaxoSmithKline.

Glaxo's PR Department must have been hard at work these past few months or so. Searching for Witty's previous roles at the company have been exhausting. His bio page on the GlaxoSmithKline page doesn't really tell us anything about him at all, particularly between the years of 1997 and 1998 when he was head of the Glaxo Wellcome marketing team. One would think that winning an award for his marketing achievements during this period would sit proudly on any person's bio or CV...not Andrew Witty's though. Maybe it's a past that he would rather forget about or maybe his recent statement [above] would seem utterly ridiculous given that he himself was part of the problem [era]

1997/98 is a period of time where Witty was heavily involved in marketing although there are very few articles left on the internet that show this.

Glaxo Wellcome'sVP-General Manager of Marketing Andrew Witty, as he was known between 1997/98, worked very closely with prescription drug ads on TV. This is known as DTC or Direct to Consumer advertising.

In August 1997 the US Food and Drug Administration [FDA] relaxed its rules on DTC, it basically meant that the FDA were giving carte blanche to the pharmaceutical industry whereby they could promote their products in TV ads without giving detailed medical information on the indications, potential side effects, or proper use. [1]

Witty was quick to pounce. Why wouldn't he? DTC is lucrative for the pharmaceutical industry, well, it is in America and New Zealand as these are the only two countries that allow TV ads for prescription medication.

Witty added more products in 1997 with Glaxo's new anti-smoking pill Zyban, [buproprion] which got an estimated $55 million in support (the brand is even got TV teaser ads prior to its launch)

For those who don't know, Zyban is also in fact Wellbutrin which is an antidepressant that Glaxo marketed off-label for a whole host of reasons that it was never indicated for. See back story here and it will show you how Glaxo hired a famous radio personality to promote Wellbutrin for  increasing someone's orgasmic potential.

If we use the generic name, buproprion, rather than the brand names it gets slightly easier to follow.

You see bupropion is used to treat major depressive disorder and seasonal affective disorder and it is also used to help people stop smoking by reducing cravings and other withdrawal effects.

So, in 1997, Witty pushed Zyban, Wellbutrin, call it what you will, onto the TV screens and into the homes of millions of Americans. He was in actual fact pushing an antidepressant onto an unsuspecting public.

Here's a Zyban ad from 1997, this is one that Witty would have been behind as Glaxo Wellcome'sVP-General Manager of Marketing. What I find remarkable about this ad is that they do not distinguish the two brand names as being practically the same. The only warning they off is, "Don't take Zyban if you are taking Wellbutrin" - Surely it would have been morally ethical to tell the consumer, "If you take Zyban and Wellbutrin together you will actually be overdosing on the active ingredient, bupropion." But hey, why would a pharmaceutical company, like Glaxo, wish to inform its consumers that a drug that could help you quit smoking was  really an antidepressant?

Of course Glaxo got around this by altering the molecule structure. Change a molecule here and there and it can give you a whole new brand name with an even bigger target audience, case in point being Celexa and Lexapro, Forest pharmaceuticals blockbuster antidepressants, they are pretty much the same, save for a bit of laboratory tweaking.

So, with Witty's marketing strategy he and his team launched Zyban.

Are we to believe that Witty had no input to the sales team? Remember his statement at the top of this post?

"Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."

We?

A number of other drugs mentioned in the whistleblower suit seem to have fallen on deaf ears in the mainstream media. Lotronex,[alosetron] a drug made by Glaxo Wellcome that was on the US market for nine months, during which time it netted them an estimated $56 million. 

Why was it taken off the market?

According to Wikipedia alosetron was withdrawn in 2000 following the association of alosetron with serious life-threatening gastrointestinal adverse effects. The cumulative incidence of ischaemic colitis was 2 in 1000, while serious complications arising from constipation (obstruction, perforation, impaction, toxic megacolon, secondary colonic ischaemia, death) was 1 in 1000. 

This from The Lancet [2]

By July, 2000, concerns about the balance of risk and benefit were being voiced.3 Between February and June that year, seven patients had developed serious complications of constipation, three of whom required surgery. Eight further cases of ischaemic colitis were reported. The FDA had an opportunity then to take stock of its earlier decision. The clinical data confirmed the substantial and potentially life-threatening risks hinted at during pre-approval review. But instead of withdrawing Lotronex and calling for more evidence, the FDA issued a medication guide designed to warn patients of escalating risks, while keeping the drug on the market.

This decision was to prove fatal. On Nov 28, GlaxoWellcome withdrew Lotronex from the market after the deaths of five patients taking the drug. There had been 49 cases of ischaemic colitis and 21 of severe constipation, including instances of obstructed and ruptured bowel. In addition to the deaths, 34 patients had required admission to hospital and ten needed surgery. A letter from Janet Woodcock, director of CDER, declared that the "FDA is committed to working with pharmaceutical sponsors to facilitate the development and availability of treatment options for patients with IBS". There was no word of sorrow or regret for the families of those who had died.

Strangely it was reintroduced to the market in 2002, although it carried warnings that were not put in place during the nine months it was previously on the market.

Although it can be said that Andrew Witty was not head of marketing during the Lotronex debacle he was, however, still Vice President - General Manager of Marketing of Glaxo Wellcome when their drug Raxar was pulled to task regarding violations of its marketing. Raxar wasn't mentioned in the whistleblower suit but it's worth mentioning because Witty was in charge of marketing during this specific time.

In 1997, Barbara Thompson, Assistant Director, Advertising Policy, FDA, wrote to Glaxo Wellcome. She told them that, after reviewing the Raxar press release it was found to be in violation [Fig 1]

Fig 1

Raxar was withdrawn from the market in 1999 for causing Prolonged QT interval.

Witty would have been in charge during the advertising faux pas and quite possibly would have been behind the press release slated for violations by Barbara Thompson [above.]

Records filed with the U.S. Food and Drug Administration (FDA) showed that Raxar was cited as a suspect in the reported deaths of 13 patients. [3]

Imitrex, a migraine product that was mentioned in the whistleblowwer suit, was approved by the FDA in 1992. Documents from the lawsuit showed how Glaxo had pushed Imitrex for mild headaches and for use in children even though it was not indicated for both.

Here's an Imitrex ad from the 1990's, it's not known if Andrew Witty was head of marketing during this particular TV ad.

Here's Glaxo's 'self test' they created with the National Headache Foundation.

Lamictal, [lamotrigine] yet another drug mentioned in the lawsuit, was FDA approved in 1994. Once again,  I think it safe to assume that any promotional push via the marketing team would have come from Witty, at least during the 1997/98 campaign.

During the promotional push for Lamictal, after Witty had moved on from his role of marketing, Glaxo hired speakers to 'big up' the drug. Documents from the whistleblower suit show 7 pages of paid speakers, many of which were child neurologists. 

In 2010 the FDA issued a warning that Lamictal use can cause aseptic meningitis, an illness characterized by serous inflammation of the linings of the brain.


Maybe Witty should come clean or maybe documents will one day surface that shows how he, as head of marketing, pushed the off-label promoting of drugs that he was in charge of. I'm sure there are lots of internal emails that haven't made the public domain... yet.

Are we really expected to believe that Andrew Witty is whiter than white and he never knew what was going on or, indeed, he never once promoted the use of drugs in people or illnesses that they were never indicated for?

I'm surprised no journalist has asked him these questions. I'd just love him to go on record and state that he has never promoted the use of any drug for off-label use either personally or by proxy to the 9,000 or so pharmaceutical reps Glaxo once had, a figure that has almost halved over the years. Nonetheless, there's approximately 9,000 potential whistleblowers who would know whether or not Andrew Witty is the shining knight in armour who has been left to stifle the stench of JP Garnier, Glaxo's former CEO.

The violations, which amount to a humongous lump of excrement, cannot all be left at the feet of Witty's predecessor, JP Garnier. Witty, himself, has to take some blame on a personal level. 

I've yet to see him do this.

Special thanks to the Truthman for digging out the 1997 article from The Advertising Age.


[1] Do Ads Really Drive Pharmaceuticai Sales? By Steven Findlay
[2] Lotronex and the FDA: A Fatal Erosion of Integrity - Volume 357, Number 9268, 19 May 2001
[3] RAXAR: Warning on Label Omits Deaths - LA Times, Fri, 02 Sep 2005





Back Stories:


GSK - The Company With Great Ethics

GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint

Advair Launch 2001: GSK's “Myth of Mild” Campaign

Glaxo Named in Antitrust Class Action Suit

The subscription based website, Law360, is reporting that GlaxoSmithKline, along with Teva Pharmaceutical Industries Ltd, have both been named in an antitrust class action lawsuit. Both have been accused of conspiring to keep a generic epilepsy drug off the market in order to maximize profits.

The complaint has been brought by LOUISIANA WHOLESALE DRUG CO., INC., [LWD] on behalf of itself and all others similarly situated:

The 41 page document reveals that the case is brought on behalf of LWD and a class of all other persons or entities in the United States who directly purchased Lamictal brand lamotrigine tablets (“Lamictal Tablets”) from GSK and/or a generic version of Lamictal Tablets from Teva at any time during the Class Period of February 17, 2008 until the effects of Defendants’ conduct ceases (the “Class”)


Law360 writes:

Louisiana Wholesale Drug Co. Inc. filed the suit on behalf of all those who purchased Lamictal-brand lamotrigine tablets since February 2008, alleging that Teva put the brakes on a patent challenge to Lamictal in 2005 in order to strike a deal with GSK that would benefit both companies while hurting consumers.

The subsequent settlement and license agreement allowed Teva to sell limited amounts of a generic version of a Lamictal chewable product in June 2005 but kept Teva from selling the more lucrative Lamictal tablets until July 2008, six months before GSK's patent on the drug expired, according to the complaint.

Glaxo hurting consumers?

Surely not?

Arise Sir Witty - time to sort out the mess left behind by old JP.





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