Who Will Replace His Royal-Ness Andrew Witty At GSK?


It seems to be that GSK just replace one sociopath with another..

I can just imagine the interview process for CEO…

We’ve had JP Garnier (he was a very good sociopath), then we had Witty (who was arguably even better).. very convincing , very slick…

Who next?

I bet it’s something like a tick the boxes ‘sociopath’ checklist for the selected candidates…

Something like this perhaps?…


2960020302001

 

 

 


http://news.sky.com/story/1661575/woodford-demands-outsider-to-take-gsk-helm

Woodford Demands Outsider To Take GSK Helm

The high-profile fund manager tells Sky News a “fresh pair of eyes” is needed to replace Sir Andrew Witty at GSK.

10:58, UK, Thursday 17 March 2016

GlaxoSmithKline Chief Executive Andrew Witty poses with his medal after being honoured with a Knighthood by Prince Charles

Sir Andrew Witty poses after being honoured with a knighthood

Britain’s biggest drugs-maker, GlaxoSmithKline (GSK), has been told to ignore internal candidates in its search for a new boss as shareholders intensify demands for a radical overhaul of the company.

Speaking exclusively to Sky News, Neil Woodford, the City’ s best-known fund manager, said that GSK needed “a fresh pair of eyes” to replace Sir Andrew Witty, who will step down next year.

“I have a strong preference for an external candidate,” the head of investments at Woodford Investment Management said on Thursday.

Mr Woodford’s demands will put pressure on Sir Philip Hampton, GSK’s new chairman, to appoint an executive from elsewhere in the pharmaceuticals industry to succeed Sir Andrew.

That would come as a blow to possible internal candidates such as Emma Walmsley, who runs GSK’s consumer products division, and Abbas Hussain, president of its global pharmaceuticals unit.

Sky News revealed last autumn that Mr Woodford was seeking a break-up of the £69bn company, which owns brands such as Nicorette and Horlicks.

He believes the group would be far more valuable if it separated its HIV business ViiV, its consumer healthcare division and Stiefel, its dermatology division, from its core medicines and vaccines arm.

GSK said on Thursday that Sir Andrew would step down at the end of March 2017, with a formal recruitment process now underway.

The City has grown frustrated at GSK’s lacklustre share price performance, with the stock down about 10% over the last 12 months as investors wait to see whether a pipeline of promising new products will deliver.

Under Sir Andrew, its chief executive since 2008, GSK has signalled a shift away from highly priced prescription drugs in favour of vaccines and consumer products.

Analysts at Deutsche Bank said the announcement about Sir Andrew’s retirement was unlikely to signal material strategic changes at GSK.



http://www.bloomberg.com/news/articles/2016-03-17/glaxo-chief-executive-witty-plans-to-step-down-next-year

GlaxoSmithKline CEO Andrew Witty to Retire in March 2017
Marthe Fourcade
Ketaki Gokhale
KetakiGokhale
March 17, 2016 — 7:12 AM GMT
Updated on March 17, 2016 — 12:10 PM GMT

Board will search for CEO candidate inside, outside drugmaker
Chairman Hampton also plans `board refreshment’ this year

GlaxoSmithKline Plc Chairman Phil Hampton began an overhaul of the biggest U.K. drugmaker by launching a search for Chief Executive Officer Andrew Witty’s successor and replacing a third of the board as he seeks to pacify some disgruntled investors.

Witty, 51, will retire next March, after almost a decade at the helm, the London-based company said in a statement on Thursday. Glaxo also plans what Hampton termed a “board refreshment” as directors Deryck Maughan, Stephanie Burns, Daniel Podolsky and Hans Wijers won’t stand for re-election at the annual meeting in May.

Andrew Witty
Andrew Witty
Photographer: Simon Dawson/Bloomberg

Witty, once hailed as one of the pharmaceutical industry’s most visionary managers, has faced criticism for Glaxo’s lagging share performance, sluggish sales and a pipeline lacking promising medicines. A bribery scandal in China that led to a $489 million fine last year also tarnished his image, which he had built with initiatives to develop the world’s first malaria vaccine and reform the way medicines are marketed to doctors.

“Glaxo needs a shakeup at the top,” said Gareth Powell, a portfolio manager at Polar Capital LLP in London whose holdings include Glaxo shares. “There’s a lack of truly innovative products, and that’s what they need to sort out.”
Right Time

Last year, Witty oversaw the biggest reorganization since the merger that created Glaxo 15 years ago. He sold the company’s cancer drugs to Novartis AG in exchange for the Swiss firm’s vaccines business and cash. The companies also formed a joint venture, controlled by Glaxo, to sell consumer health products.

Glaxo shares fell 1.3 percent to 1,394 pence at 12:07 p.m. in London trading. The stock has returned an average of 10 percent a year over the past five years, compared with a 17 percent average annual return for the Bloomberg Europe Pharmaceutical Index.

“By next year, I will have been CEO for nearly ten years and I believe this will be the right time for a new leader to take over,” Witty said in the statement. He began leading Britain’s largest drugmaker in 2008 after more than 20 years at the company, including postings in the U.S., Asia and Africa.
Avoiding Deals

Both internal and external candidates will be considered for the role. Glaxo investor Neil Woodford said he would like to see someone from outside the company take the top job. One of that person’s first tasks may be to slash the dividend, investors said.

Potential candidates include Emma Walmsley, head of Glaxo’s consumer-health division, and Abbas Hussain, president of its drug business, according to reports in U.K. media. Chief Financial Officer Simon Dingemans and Roger Connor, who oversees global manufacturing and supplies, may also be considered as internal successors. David Epstein, head of Novartis’s pharmaceutical unit, may also be approached, the reports said.

Witty’s views have diverged from those of his peers. He has avoided large-scale acquisitions that have consumed others such as Pfizer Inc. and Teva Pharmaceutical Industries Ltd. And in 2011, he started a program called Patient First that eliminated the link between sales targets and bonuses for Glaxo’s U.S. marketing team, following allegations of illegally promoting drugs. Few drugmakers followed his lead.
Fresh Board

Glaxo’s sales declined to 23.9 billion pounds ($34.2 billion) last year from a peak of 28.4 billion pounds the year after Witty joined. Core earnings per share will probably surge this year, the company has said, after two years of declines.

“The decision will allow him to step aside at a high point following the company’s expected return to double-digit earnings growth in 2016,” Richard Parkes, an analyst at Deutsche Bank AG in London, wrote in a note to clients.

One bright spot has been Glaxo’s portfolio of HIV medicines, which the company considered spinning off in an IPO before opting to keep it. The British drugmaker also has one of the broadest drug pipelines in the industry, with more than 70 new medicines in development (though many are early-stage drugs that won’t deliver sales anytime soon), according to a Bloomberg Intelligence pipeline analysis.

A breakup of the company, favored by some investors including Woodford, might not generate that much value, according to an analysis by Bloomberg Intelligence analyst Sam Fazeli. Separating the drugs, vaccines and consumer-health units will probably increase Glaxo’s enterprise value of 83 billion pounds ($118 billion) by 10 percent or less, he estimated.

Forbes Nails Andrew Witty And GSK’s Agenda For What It Is : Utter BS!


It is quite remarkable to see a mainstream corporate news agency like Forbes really nail the problems of GSK and the various ethical/integrity issues that surround Andrew Witty’s tenure as CEO. Great article, and It would be great to see more like it from the mainstream media.

We- the bloggers- have been calling out GSK on their hypocritical corporate bullshit for years now- so it’s good to see some journalists, from the mainstream, are finally catching up. Well done  to Forbes for having the balls to tell it like it is. Kudos. 

http://www.forbes.com/sites/erikakelton/2014/04/28/glaxosmithklines-spin-doctoring-doesnt-cure-corruption-problems/

Erika KeltonErika Kelton Contributor

I write about whistleblower matters involving fraud and other issues.

INVESTING 4/28/2014 @ 5:02PM 1,737 views

GlaxoSmithKline’s Spin Doctoring Doesn’t Cure Corruption Problems

Andrew Witty, GlaxoSmithKline GSK -0.49%’s CEO, has been a busy man over the past couple years, taking every opportunity to convince the public that the company has reformed its culture and marketing practices.

But despite the full-on PR campaign, claims continue to surface about Glaxo using bribes to induce doctors to prescribe Glaxo drugs. Allegations of Glaxo’s bribery in China have hung over the company for nearly a year, and just recently similar concerns have been raised publicly about the company’s marketing practices in Poland, Iraq, Jordan and Lebanon – in all, a list that is becoming as long as an Amazing Race itinerary.

It has been less than two years since Glaxo paid the US government a record-setting $3 billion to settle a range of fraud and bribery allegations, including allegations that it paid kickbacks to doctors to prescribe Glaxo drugs and that it marketed many of its drugs for unapproved uses, making unsubstantiated claims about results. (A number of those allegations were raised by whistleblowers my firm represented.)

Untitled

 

GlaxoSmithKline Chief Executive Officer Andrew Witty said “displaying integrity” is a company priority, but the recent spate of bribery allegations belie those words. 

If the latest allegations are true, Andrew Witty will need to work overtime to dispel the conclusions that Glaxo simply “off-shored” illegal sales tactics first developed in the United States and that the pharma giant continues to foster a culture where bribery and kickbacks are considered standard sales practices.

CEO Witty promised in 2012 that GSK would make “displaying integrity in everything we do” a priority. However, the temptation of rapidly growing markets in Asia, the Middle East and Europe may have proven too difficult to resist. After all, it’s harder to convert “integrity” into rising share prices than it is to boost profits through questionable business practices.

The flood of bribery allegations is a test even for Glaxo’s professional spin doctors who, rather ironically, try to distract the public from bad news on the ethical front by announcing the company’s latest steps to reinvent itself as an ethical business venture.

For example, prior to its November 2011 announcement that the company would pay $3 billion to resolve the U.S. liabilities, Glaxo moved to pre-empt the bad news by announcing it was changing its US sales representatives’ compensation structure so that they would no longer be rewarded based on the volume and value of prescriptions sold. Such incentive-based compensation is considered to encourage illegal practices that drive sales.

But as the latest alleged bribery revelations suggest, limiting those changes to the US sales force left the rest of the world – including Glaxo’s most rapidly growing markets – open to questionable practices encouraged by incentive compensation structures that Glaxo failed to change outside the US.

In 2013, dogged by numerous media stories that it was bribing doctors in China to prescribe its drugs, Glaxo tried to blunt the fallout by belatedly announcing that all of its sales representatives worldwide would be compensated under the same terms as its US sales force, replacing financial incentives based on sales with ones based on the quality of service sales reps provide doctors and other healthcare providers.

Then in March, a top Glaxo official said in a media interview that Glaxo would hire doctors in-house to market its drugs, rather than pay physicians to speak to other doctors about its products. Within just a few weeks, like clockwork, allegations of GSK bribing physicians in Iraq, Jordan, Lebanon and Poland surfaced.

One gets the feeling that Glaxo’s compliance efforts are geared more to pre-empting bad news than they are to making meaningful and effective changes to its business culture.   Glaxo’s piecemeal approach to compliance holds back on clearly needed wholesale changes while the executive suite waits for the next investigation of unethical conduct to crop up.

With Glaxo’s recent history, it is hard to keep a straight face when reading the company’s statement responding to the latest bribery allegations involving Jordan and Lebanon. Glaxo declares: “We are confident in our processes and controls and that we do not have a systemic issue with unethical behavior in GSK.”

If Glaxo truly doesn’t recognize that bribery allegations in multiple countries around the globe add up to a “systemic issue,” then the company has even bigger management problems than it seems. In that case, GSK and Andrew Witty should be prescribed a full dose of reality – with unlimited refills.

 

 

 

 

GlaxoSmithKline and Roche won’t disclose their results (2013)


A year ago GSK announced that they would give access to their clinical trial data, and pundits like Ben Gold-acre praised them to the public,  for ushering in this so called ‘new era’ of transparency…

But astute observers are aware that GSK are playing this data game only on their terms… and transparency is determined strictly by their definition… they control the game…

and of course, ultimately this game will all play out to the tune of their agenda…

2014 should be intriguing…

 

 

http://www.bmj.com/content/346/bmj.f819/rr/633959

 

GlaxoSmithKline and Roche won’t disclose their results

5 March 2013

GlaxoSmithKline (GSK) and Roche have declared they are willing to disclose their trial data. But not like the European Medicines Agency, which from January 2014 will provide public access to the full clinical study reports for all new drugs, the corresponding protocols, and the raw data in statistical programmes and the codes – without conditions.

If we shared our data, it would lead to tremendous progress for public health (1). But this is not what GSK (2) and Roche have announced (3). The companies will establish committees of “experts” that will decide whether people can get access to patient level data. And GSK will only allow access after it has published the trials. What about trials that never get published?

Does anyone really believe that the companies will allow access to the data if the research could potentially show that one of their blockbusters is so dangerous that the drug agencies will withdraw it? Or that Roche is willing to run the risk that governments won’t buy any more Tamiflu after they have seen the data?

Instead of providing the full clinical study reports, GSK will take the trouble to strip out all patient level data. This means we won’t be able to detect when GSK has manipulated their analyses, which they and other companies often do. Here are some examples related to GSK:

1) Not only GSK, but also Eli Lilly and Pfizer, added cases of suicide and suicide attempts to the placebo arm of their trials of antidepressants, although they didn’t occur while the patients were randomised to placebo (4-8). Professor David Healy pointed this out, and it wasn’t denied by the companies but GSK instead called Healy’s analysis “scientifically invalid” and “a disservice to patients and physicians” (9).

2) Cases of suicidality were coded as hospital admission, drop-out, worsening of depression or emotional lability by several companies (4). In the BBC Panorama series about paroxetine, Glaxo’s spokesperson, Dr Alastair Benbow, denied in front of a running camera that paroxetine could cause suicidality or self-harm but one month later he sent trial data to the UK drug regulator that showed exactly this, which immediately led to a ban on using the drug in children. GSK stated that they “detected no signal of any possible association between Paxil and suicidality in adult patients until late February 2006,” but US government investigators found that the company had the data back in 1998 (10).

3) GSK denied for years that paroxetine was habit forming, although paroxetine led to withdrawal reactions in 30% of the patients in the original licence application (11). In 2003, GSK quietly and in small print revised its previous estimate of the risk of withdrawal reactions in the prescribing instructions from 0.2% to 25% (12), a 100 times increase.

4) Glaxo’s trial 329 of paroxetine in children and adolescents was negative for efficacy on all protocol specified outcomes and positive for harm but data massage produced four statistically significant effects after splitting the data in various ways (13,14). The paper falsely stated that the new outcomes were declared a priori. At least eight children became suicidal on paroxetine versus one on placebo, but in the published paper, five cases of suicidal thoughts and behaviour were listed as “emotional lability” and three additional cases of suicidal ideation or self-harm were called “hospitalisation.” The abstract of the paper concluded that “Paroxetine is generally well tolerated and effective.” Trial 329 was widely believed and cited (184 times by 2010), and it lured many doctors into using paroxetine for childhood depression, although the drug is harmful. The trial has not been retracted despite repeated calls on the journal to do so. The Attorney General of New York State sued GSK in 2004 for repeated and persistent consumer fraud in relation to concealing harms of paroxetine, and GSK was required as part of a legal settlement to make the individual patient level data from that trial available, but they didn’t do so. Only when Dr Peter Doshi contacted the New York Attorney General’s office in 2012 and said that the data weren’t there, did the data get posted. The clinical study report is now available on GSK ‘s home page (http://www.gsk.com/media/resource-centre/paroxetine/paroxetine-paediatri…) and it contains revealing narratives of serious adverse experiences. For some unexplained reason, the four authors of GSK’s study report have been replaced by xxxxx x xxxxxx, B.S.*, xxxx xxxxx, Ph.D.*, xxxxx x xxxxxxxxxx, B.S.*, xxxxxxxx xxxxx, M.S.**.

5) An FDA scientist found that the adjudication of cardiovascular events in the RECORD trial of rosiglitazone was seriously flawed. He found many missing cases of cardiac problems that favoured rosiglitazone four to one (15,16) and that rosiglitazone increased cardiovascular risk, in contrast to Glaxo’s results. He concluded that the case report forms are essential for understanding a study and noted that, “even with blinded adjudication, biased referral for adjudication of cases and data by unblinded investigators and site monitors may lead to biases in event rates” (16). In 1999, the company, then known as SmithKline Beecham, completed a trial that found more cardiac problems with rosiglitazone than with pioglitazone, but according to an internal email, “These data should not see the light of day to anyone outside of GSK” (15,17). The company spent the next 11 years trying to cover them up (17).

6) Because of concerns that long-acting beta-agonists might increase asthma-related deaths, the FDA asked GSK to carry out a large trial of salmeterol, the SMART trial. The trial period was 28 weeks, but the investigators could – if they wanted – report serious adverse in an additional 6 months period. The FDA assumed that the data they reviewed stemmed from the trial period, and only when the agency asked, did GSK reveal it had included the follow-up data. There was no statistically significant increase in asthma-related deaths in Glaxo’s analysis, whereas the risk was four times higher for the trial data, which was statistically significant (18).

7) In 2008, Professor Jens Lundgren received a death threat at the international AIDS congress in Mexico City in an SMS before he presented data showing that Glaxo’s £600 million drug, abacavir, almost doubles the risk of heart attacks (19,20). As soon as Lundgren had finished his talk, he was escorted to the airport with eight body guards. It was not possible to trace where the death threat came from.

Right now, the drug industry fights tooth and nail against access to trial data. In relation to the proposed revision of the EU Clinical Trials Directive the industry argues that a summary of the results is all that is needed, although we know we cannot trust summaries. We cannot trust the industry either when it says it’s committed to full transparency (3):

“Roche is supporting the European Medicines Agency (EMA) in its commitment to the proactive publication of data from all clinical trials supporting the authorisation of medicines.”

If Roche was serious about this, then why the obstacles?

References

1 Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011;12(1):249.

2 Kmietowicz Z. GSK backs campaign for disclosure of trial data. BMJ 2013;346:f819.

3 Roche launches new process for accessing clinical trial data. Press release 2013 Feb 26.

4 Healy D. Let them eat Prozac. New York: New York University Press, 2004.

5 Healy D. SSRIs and deliberate self-harm. Br J Psychiatry 2002;180:547.

6 Healy D. Did regulators fail over selective serotonin reuptake inhibitors? BMJ 2006;333:92-5.

7 Healy D, Cattell D. Interface between authorship, industry and science in the domain of therapeutics. Br J Psychiatry. 2003;183:22-7.

8 Lenzer J. FDA to review “missing” drug company documents. BMJ 2005;330:7.

9 Rockhold F, Metz A, Traber P. Response from GlaxoSmithKline. Br J Psychiatry 2002;180:548.

10 Grassley CE. Paxil. Speech at the US Senate 2008 June 11.

11 Herxheimer A, Turbulence in UK medicines regulation: A stink about SSRI antidepressants that isn’t going away. Chapter 10. In: Glavanis K, O’Donovan O (eds). Power, Politics and Pharmaceuticals: Drug Regulation in Ireland in the Global Context. Cork University Press, 2008.

12 Medawar C, Hardon A. Medicines out of control? Antidepressants and the conspiracy of goodwill. Netherlands: Aksant Academic Publishers, 2004.

13 Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008;20:73-81.

14 Jureidini JN, McHenry LB. Conflicted medical journals and the failure of trust. Accountability in Research 2001;18:45-54.

15 Cohen D. Rosiglitazone: What went wrong? BMJ 2010; 341:530-4.

16 Psaty BM, Prentice RL. Minimizing bias in randomized trials: the importance of blinding. JAMA 2010; 304:793-4.

17 Harris G. Diabetes drug maker hid test data. New York Times 2010 July 13.

18 Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. Lancet 2005;366:1261-2.

19 Glaxo ‘downplayed’ warning on heart-attack risk from AIDS drug. The Independent 2008 May 12.

20 Brix SM. [Researcher receives death threats]. Universitetsavisen 2008;14:5.

Competing interests: None declared

http://1boringoldman.com/index.php/2013/03/08/cat-and-mouse-mice/

Ben Goldacre [AllTrials], Fiona Godlee [BMJ], and the Peter Gøtzsche [Nordic Cochrane Group] seem to be in a fairly intense cat and mouse game with Roche, GSK, and by proxy everything PHARMA over the meaning of the term data transparency. They mean “all of it” – the protocols, the raw data reports, everything the people doing the study have the opportunity to see themselves – including the data for studies not slated for publication – including the studies going back for thirty years. While it seems a bold request, the behavior of the pharmaceutical companies has been so regularly egregious that complete data transparency has moved from the level of a request to a requirement. At least in psychiatry, it would be unethical to practice just relying on the kind of information that has been available to us in the last several decades now that we know how far off the mark it has actually been – both in terms of efficacy and adverse effects, particularly the latter.

There is little question that these measures will negatively impact the profitability of pharmaceuticals, but those are clearly ill-gotten gains. The only rational alternative would be to dramatically tighten the FDA/EMA approval processes. And it seems a better solution for medicine itself to assertively assume the watchdog role. Medical ethics are neither the domain of pharmaceutical companies nor the government. That contract needs to be between physicians and patients. If we physicians are to be the gatekeepers and the dispensers of medications, then it’s our collective responsibility to do the checking so we know what we’re talking about. We can’t do that without access to those raw data sets.

On the other hand, no matter how well justified, the odds that the pharmaceutical industry will voluntarily agree to these conditions are about as good as those of that mouse on the right voluntarily walking out through the mouse-hole. The drug industry sees this campaign for Data Transparency as an invitation to commit suicide on Wall Street.

In psychiatry, there is a larger problem. Psychiatry has redefined itself over the last thirty years under the influence of the third party carriers, the pharmaceutical industry, and the body of organized and academic psychiatry to become clinical neuroscience [meaning psychopharmacology]. To further complexify things, the American Psychiatric Association is set to release its DSM-5 in May, a diagnostic manual created under the over-riding influence of the clinical neuroscience meme. So we have yet another cat and mouse scenario.

One might ask, “Who is the cat and who is the mouse?” Certainly the power base seems to be on the side of the pharmaceutical industry, the third party carriers, academic and organized psychiatry, and a still deluded populace who have been led to believe that these medications are more powerful and safer than they really are. Is this one of those times when a bunch of do-gooders can finally go against that kind of power and prevail? Sure. Look who’s on the run…
  1. Annonymous
    March 8, 2013 | 10:03 AM

    Let’s be clear, alltrials and Goldacre are explicitly NOT demanding patient-level stat access across the board.
    The new BMJ publication rule does speak to this, and it will be much much harder for researchers to deny access to patient level data when a problem is apparent from the clinical trial reports.
    I think alltrials needs to be backed wholeheartedly.
    But, I think it is important that it be clearly understood that alltrials is leaving out patient level data out of its main demand. Likely to start with a broad tent. And, to strip Pharma of its main counter-strategy.

  2. Annonymous
    March 8, 2013 | 10:11 AM

    There is also the question of whether or not the campaign’s longterm success depends on the awareness of clinicians in the US. 1BOM, how many of your compatriots have read the book?

  3. March 8, 2013 | 10:50 AM

    “Hear experts give oral evidence @commonsSTC about clinical trials next Wednesday 13th March http://www.parliament.uk/science/ #ALLTrials”

    My compatriots in Parliment have…

  4. Annonymous
    March 8, 2013 | 12:57 PM

    Those kind of compatriots will not show the ongoing vigilance needed to assure more than another set of “fake fixes.” We need a more fundamental understanding of the problem, and of the stakes, among physicians in order for 2013 to be different than 2008. If most of your fellow physicians have not heard of Goldacre’s book, much less read it, then that is a concerning state of affairs indeed.

  5. wiley
    March 8, 2013 | 6:46 PM

    I read about Dr. Drew and how his “patients” are killing themselves under his “tough love” approach to drug addiction that televises their withdrawal and profits from it, and I wondered whence the AMA? Can they not threaten this man’s licence for torturing his patients with Folk Psychology? He is not practicing medicine, he’s practicing the third-rate morality of an Elmer Gantry type huckster.

  6. berit bj
    March 9, 2013 | 9:06 AM

    BMJ has interviewed Andrew Witty, CEO of GSK, the British pharma giant recently fined 3 bn dollars in USA for criminal actions, off label promotion of dangerous drugs the most serious, most profitable, global sales around 10 bn pr year for the drugs in question.
    Witty looks his part, youngish, clean, a prince – fighting for the kingdom with weapons at his disposal. The power of charm, deception, money is set to postpone necessary changes for transparency, honesty, accountability as far into the future as politically possible.
    But governments footing the greater share of the pharma bill must – sooner or later – have to side with their populace – if democracy is to be their game. Tyrants come in unfamiliar guises, the pretty princes hard to unmask, a tale repeatedly told in the theaters of life, in private as in public.
    Nothing scared me more than having to realize our fundamental insecurity, always potentionally at the mercy of dark forces yet unseen, hiding in benevolent world figures, and in the doctor, nurse, MP, PM, CEO, father, brother, mother. Jaspers warned of the everpresent danger of fascism.

The Flaws In Ben Goldacre’s ‘Evidence Based Medicine’ Transparency Agenda


Ben Goldacre

Ben Goldacre has become somewhat of a ‘key opinion leader’ in the arena of science and pharmaceutical practices. His approachable persona, backed by his best selling books and much-read Guardian column, has made him into something of a celebrity in the UK. He has done TED talks and even appeared in Stephen Fry’s QI TV show. He has over 250,000 twitter followers and many more fans who comment on his bad science blog. He is asked his opinion on a range of different issues, from health care to public policy. When Goldacre expresses his opinion- people listen…he’s quite popular.

Perhaps this is why GSK are so keen to be associated with him?

Ben has been running a campaign for access to all clinical trial data, through his Alltrials organization, and he’s even managed to get GSK to sign up to it. Although it sounds fairly promising (if you believe the PR sound-bites) ,GSK haven’t actually delivered on anything yet, but they have made some half-baked promises about access to their clinical trial data in the coming years (how, when, or in what form- this transparency will be- is still very vague and unclear). Of course transparency itself is all well and good (and indeed I applaud Ben for such a noble aspiration)  however, what use is the clinical trial data (or evidence based medicine) when it is manufactured, analysed and selectively interpreted by the drug makers themselves? (and of course there is also the possibility of destroying the unfavorable data altogether and never letting it see the light of day- if it no longer exists – you can’t be expected to show it). It’s issues like those mentioned, as well as many others, which highlights the impotence of Ben Goldacre’s quest for transparency from the industry. Nonetheless, the good PR generated for pharma for appearing to usher in an era of transparency earns companies like GSK many ethical brownie points (which are undoubtedly invaluable in a highly competitive market with so much public mistrust and cynicism towards it from the general public).

Ben’s argument rests upon the premise that randomized clinical trial data (RTC’s) presented by the pharmaceutical industry is the gold standard of assessing risks and benefits of medications. He calls for access to all clinical trials because he claims that the industry suppresses the negative trials and promotes the positive ones. He is correct here- this is what industry does and this is of course unethical and wrong, and it’s been going on for decades. Of course all data should be published, and it’s amazing how the industry have gotten away with this sham for so long.

Nevertheless, this focus on suppression of negative trial data is really a bit of a red herring, because not only do companies like GSK hide negative data about their drugs, but they also have the power to manipulate the trials both in their design and interpretation- in order to generate an appearance of efficacy and safety. They control the whole process, they create the data, they design the methods and they interpret the results, therefore it is the process itself which is corruptible. This is far from a gold standard, and many dangerous medications still make it to market- despite regulatory approval based on clinical trials! (Vioxx, Avandia, Seroxat, Zyprexa … to name but a few of the recent past). 

Dr David Healy explains how they do this in an interview here:

“There are a few ways that RCTs can hide effects. First, the process doesn’t encourage anyone to look closely at particular things that happen on a drug—the focus is instead on the group and on average effects. That’s true of all trials. In company trials there are more specific problems like miscoding, where suicidality becomes “nausea” or “emotional lability” or even “treatment non-responsiveness.”

There is also the problem of mislocation—patients on placebo end up being given problems they never had—and of nonexistent patients, who don’t of course have adverse events.

Beyond that, there are more sophisticated tricks that companies can and do play—such as claiming that increased rates of a problem on a drug are not really evidence of an increase in rates if the data are not statistically significant. In this way, companies have hidden many more heart attacks on Vioxx and Avandia or suicidal acts on SSRIs than have been hidden by miscoding or mislocation.

Isn’t what you’re describing tantamount to

fraud? I’m all in favor of clinical trials—if done right, wouldn’t they give us the correct answer?

Actually no, when it comes to adverse events, trials almost never get the right answer.

Let’s assume in a trial that we have 3,000 depressed patients on Paxil who had 10 suicidal acts and 1,750 on placebo who had 0 suicidal acts. Paxil clearly causes suicidal acts here. Now let’s take 200 depressivepersonality disorder patients on Paxil who have 30 suicidal acts and 200 depressive personality disorder patients on placebo who have 25 suicidal acts—again, that’s an increased rate of suicidal acts on Paxil. But add these two increases together and you end up with a reduced rate of suicidal acts on the SSRI compared to placebo—40 suicidal acts in 3,200 patients is less than 25 in 1,950.

Hey presto—problem gone. Exactly the same thing can happen in every clinical trial where we don’t fully understand the condition we’re treating—which is, frankly, most conditions from back pain to diabetes to psychosis. We mix patients who superficially appear the same but who in fact have different conditions.

That is just one trick that no-one ever mentions—I’ve laid out several more on davidhealy.org.

Is there any way to overcome such tricks and masking problems?

Yes, actually, there is. One way is to do trials in healthy volunteers—these are the true drug trials. Companies do these but rarely publish them. There’s no register of these trials and no data are made available, though there’s no issue of clinical confidentiality involved. Given that these trials tell us so much—10 years before Zoloft came on the market, for instance, they indicated that the drug made healthy volunteers suicidal—it’s a huge scandal that these data in particular are buried.”

Another problem is- although clinical trial data can be useful, most clinical trials of psychiatric drugs are merely 6 to 12 weeks in duration– they are way too short to assess risks. Short trials give little (or virtually no) indication of long term affects for a lot of drugs. In the case of psychiatric drugs, it can take some weeks (and even months) for the drug to fully metabolize in the body. It can take even longer for the body to develop tolerance and dependence. Each individual is different therefore they will have a different reaction and the side effects will vary. It is often – only after a few years on the drug -that people realize that they are having serious side effects. In the case of Seroxat – it seems the longer the individual remains on Seroxat the greater the risks increase, and the harder it is to come off it. Problems like withdrawal, addiction, and issues of toxicity, are often only discovered long after the drug is approved thus only after many millions of people have been taking it for a few years.

GSK have altered the Seroxat PIL so many times over the years that if you compare the first PIL from 1991 to the ones from the last few years they are barely recognizable as so many side effects (and rates of occurrence of side effects) have been added.

See here: http://seroxatsecrets.wordpress.com/2009/12/30/the-seroxat-paxil-pil-over-the-years-ch-ch-ch-changes/

Corruption of clinical trials and falsification of data does happen, therefore in trusting in clinical trials, we have to also trust that the people involved in the trials are ethical. Seroxat Secret has highlighted this problem on his blog : see here

GlaxoSmithKline is the subject of more bad publicity after a researcher was allegedly found to have falsified data in trials about Paxil. Meanwhile, the drug maker faces lawsuits alleging newborns suffered Paxil Birth defects when they were exposed to Paxil prior to birth.

The psychiatrist who reportedly falsified clinical data, Dr. Maria Carmen Palazzo, was a clinical investigator on studies conducted by SmithKline Beecham (doing business as GlaxoSmithKline). According to CNBC on 8/20/10, Palazzo has now pleaded guilty to 15 counts of failing to prepare and maintain records with the intent to defraud and mislead.

Palazzo reportedly included children in a study that involved diagnoses the children did not have. Prosecutors claimed that Palazzo also reported symptoms that her study subjects did not exhibit. She was sentenced to 13 months in prison, which she is serving at the same time as an 87-month term for healthcare fraud.

According to BNET (08/19/10), Palazzo was charged after the Federal Drug Administration (FDA) accused her of enrolling children in studies of obsessive-compulsive disorder and major depressive disorder even though the children she studied did not have the proper diagnosis for inclusion in the study.

Paxil now carries a black box warning about the risk of suicide in children. It also carries a warning about the risk of birth defects in babies exposed to the antidepressant prior to birth.

Remember, Glaxo has a track record of hiding negative clinical trial data that would knock sales of its drugs – the story of Seroxat and Study 329 is truly shocking.

Read more about Seroxat here:
More on Paxil and suicide – “Glaxo was aware of this risk, and hid it”

and here:

Glaxo fails in its responsibility to patients and it hid Seroxat data – it’s official

And what happens in the UK when the MHRA  undertakes a criminal investigation into Glaxo and the withholding of clinical trial data?… and finds Glaxo guilty…?

The answer is nothing happened to Glaxo – nothing at all.”

Even when some companies get a negative result from a clinical trial, they can hire ghost writers to fluff up the results and make it appear that the trial was a positive one. This happened with Seroxat study 329 and tragically many children and young people were prescribed an extremely harmful drug because of it. See here :

The court documents released as a result of one of the lawsuits in October 2008 indicated that GSK “and/or researchers may have suppressed or obscured suicide risk data during clinical trials” of Seroxat. One of the investigators, “Charles Nemeroff, former chairman of the Department of Psychiatry at Emory University, was the first big name ′outed′. In early October 2008, Nemeroff stepped down as department chair amid revelations that he had received over $960,000 from GSK in 2006, yet reported less than $35,000 to the school. Subsequent investigations revealed payments totaling more than $2.5 million from drug companies between 2000 and 2006, yet only a fraction was disclosed”.

Disclosure of all clinical trial data is a step in the right direction, and it is a major issue which needs to be addressed, and I sincerely applaud Ben Goldacre for highlighting what he believes to be an important issue, but the problems of drug regulation, broken ethics, undue influence of industry on academia, and corruption in the industry itself, also need to be addressed if we are to avoid patient deaths from defective and dangerous drugs which should not have been approved.

Companies like GSK operate above the law in the UK, they are virtually untouchable. Perhaps if Ben Goldacre was to concentrate his efforts on attaining  justice for those harmed by medications such as Seroxat and Avandia, GSK might begin to manifest a sense of real atonement and change, or at the very least they might say sorry. It is only through the courts that GSK would be forced to reveal and disclose hidden information and data. But again, unfortunately, in the UK, pharma-litigation cases are usually squashed before they get to trial. The establishment have a vested interest in protecting GSK, they are a major UK cash-cow… and despite an utterly dire track record of  harm to consumers, corruption, lies and fraud for decades, they even have the UK prime minister defending them. What hope is there, for damaged patients from GSK drugs, in a situation like that? What hope is there for justice?

Ben Says:

“I don’t think GSK will be the only company to sign up. I think we’re going to enter a very interesting era where potentially the market is differentiated by ethical companies who’ve made a commitment to sharing all their trial results, and unethical companies who are still aggressively defending their ability to withhold information from doctors and patients.”

I agree with Ben here, that era is now upon us, and GSK have gained more positive publicity than any other company for basically promising to be more ethical.

Essentially they have positioned themselves quite strongly within this frame because it is in their economic interest to appear to want to be an ethical company.

They haven’t actually delivered on any of this yet and I sincerely hope that they do, but I have a feeling that they will find a way around it while still seeming to be the good guys.(they are a clever bunch). But for the time being, they are certainly generating a lot of column inches full of positive praise because of all this (such great PR for them).

Furthermore, ironically, GSK have said they will only give access to data for drugs released after the company merger (after 2000) therefore the hidden  trials of the most dangerous and infamous of their drugs- Seroxat (1991) and Avandia (1999)- will likely never see the light of day…

How convenient for them

How tragic for the families of the dead and the damaged..

As David Healy said:

“Now it is unfair to say if Ben Goldacre didn’t exist perhaps Andrew Witty would have to invent him?”

Indeed, that would be (fairly) unfair..
However, I’m not the only one to express such cynicism about GSK and their promises of transparency, see the following comments from this article about GSK’s promises..

“He’d like to see all of the clinical study reports ever completed brought out of “dry storage archive…and everywhere else that people stack their old, crinkly, yellow paperwork” and made publicly available — ideally on his new website, AllTrials.net, which recently signed on GlaxoSmithKline (GSK) to release every study the company has ever done.  (Mistake —  anything after the merger (2000)… NOT every study the company has ever done

Beverly Richards-Smith, PhD”02/24/13

“How will Dr. Goldacre or AllTrials.net ensure that GSK, or any pharmaceutical company that registers in the future, actually provides all its “old, crinkly, yellow paperwork?” It will remain up to the corporations to determine what trial results are “located” and made public. I suspect that results from older trials for drugs that have been superseded by newer products will be provided in their entirety when possible, but those for drugs that are sources of significant current corporate income will be cherry-picked to exclude negative data of a sort that might reduce the drug’s prescription rate. The threat of lawsuits resulting from lethal or severe side effects is less likely to keep a study off the Web site, as Big Pharma regards lawsuit settlements, even on what appears to outsiders to be a large scale, simply as part of the cost of doing business. If the side effects can be “justified” by the supposed benefits of the drug – e.g., 1-2% risk of diabetes vs. the claims of protection from heart attacks for statin drugs – then prescription numbers won’t be affected..”

Our “evidence-based” medicine is only as good as the “evidence”. So if the “evidence” is bad—meaning poorly constructed studies, badly interpreted or just plain fraudulent data—then so is the recommendations, policies and practices developed using that “evidence”..

jmz, MD

02/25/13

“What a waste of time, as Dr. Goldacre, like many before him, think the data should be on his site where evidently he can judge its importance. What a crock. As far as I know, GSK has already reneged on their promise. They never will release all their data and others will not also. The same is true for almost all funded research. Not all data is released and even if it were released, it would likely not be possible to analyze it because many internal information items would be missing. It’s a pipedream and please tell me how “evidence-based medicine” would improve. It sounds to me that Dr. Goldacre is after fame that is not his due..”

Bay Area MD

03/02/13

“The application of evidence-based medicine is often misguided and indiscriminately applied to a larger population than what the studies often show with few if any postmarketing studies showing the true insignificant benefits and/or greater harm created. The withholding of negative data is unethical and prevents real peer review. Evidence based medicine is quite a disappointment..”

 

What’s Really Behind GSK’s New Business Model? (From Mad in America Blog)


http://www.madinamerica.com/2013/12/whats-really-behind-gsks-new-business-model/

What’s Really Behind GSK’s New Business Model?

3

December 20, 2013

GSK has recently announced that it will cease paying doctors for promoting its drugs and sponsoring them to attend conferences and sever the link between pay for its sales representatives and the numbers of prescriptions physicians write.

Commentary from the critics of GSK have attributed the changes they are making to pressure from the government or the requirements of recently enacted legislation. My assessment of the situation is that this could not be further from the truth.

In my view, the key to GSK’s actions is in a small paragraph from the Chair of the Board in their most recent annual report which reads “Operating in a responsible and ethical way is essential for the commercial success of GSK.”
From a business perspective there are very clear reasons why GSK are doing this and why other pharmaceutical companies will follow suit. My reading of GSK’s annual report leaves me in no doubt that they are changing their business model because it is likely to increase their profitability – not because they are being forced to. I do not think GSK is concerned to any great extent about legislative change because it, along with the other players in the pharmaceutical industry, has considerable power not only to influence US legislation but to control the legislation of other countries.

Consider the Trans Pacific Partnership Agreement (TPPA) currently being negotiated between eleven Asian and Pacific-rim countries, including the United States. Key to this agreement are
• the protection of patents by US pharmaceutical companies which would see member countries’ domestic legislation controlled or overturned

• provisions for pharma to sue governments for millions in damages for undermining the value of their investments by purchasing generic drugs; and
• compensation for drug companies if the market approval process for medicines extended beyond a drug’s patent term.

The proposed Article 15 of TPPA would specifically prevent countries enacting law that was unanimously agreed by all parties in their Parliaments.

Across the countries represented, the unprecedented secrecy under which these negotiations have taken place has been strongly criticized. This secrecy does not extend to the pharmaceutical industry however. The Dominion Post in New Zealand reports that a politician with top-level United States security clearance was barred from viewing the draft text as was US Senate finance subcommittee on trade chairman Ron Wyden who sits on the committee that oversees America’s intelligence agencies but that “more than 600 representatives of pharmaceutical and film corporations are given access because they are deemed to be US Government ‘advisers’’’

Surely, you may be thinking, if the pharmaceutical industry had this power the first thing it would do is to dismantle the regulatory process, removing the need to obtain very expensive approval before marketing its drugs. Not so. Strong regulation serves a very important function in any industry that of providing a strong barrier to entry for new competitors. Michael Porter of Harvard Business School, a world leading authority on company strategy and competitiveness, identifies barriers to entry for new companies as one of the keys to industry profitability.

The cost of the drug approval process is a significant barrier to the establishment of new drug companies and therefore a deterrent to the entry of new competitors to the market, something that works in the favour of pharmaceutical companies. Far better to control regulators like the FDA than to abolish them, and that’s exactly what Big Pharma have done. The regulatory process also serves the interests of pharmaceutical companies by giving the consumer a sense of security that drugs have been through an independent quality control process.

Removal of the regulatory regime could see a flood of new pharmaceutical companies enter the market, increasing competition and reducing profits. The goal of pharma is to control regulation, not to abolish it and there is ample evidence that they have been successful in achieving control of regulatory policy and practice internationally.

In my view, the key driver of GSK’s shift away from providing incentives to doctors and to their sales reps for influencing prescribing practice is that these practices threaten their profitability.
The only distribution channel (the path through which goods and services travel from the vendor to the consumer) for prescription drugs is the medical profession, and the actions of the pharmaceutical industry have undermined confidence in the honesty and integrity of this channel. Low levels of trust in the medical profession result in reduced profitability for Big Pharma.

Americans are turning to complementary and alternative medicine because they feel the current healthcare system is failing them for many reasons. These, according to an analysis of the CAM market include “cost prohibitive prescriptions, impersonal & dismissive physicians, a heavy reliance on drugs, misdiagnosis, and conflicting views regarding the maintenance of wellness. “

GSK’s recent prosecutions and fines have undermined their reputation but in practice this is unlikely to have much impact on sales. Governments not consumers are their customers and government purchasing agents are interested in the quality and price of drugs not in whether the company who produces them behaves ethically or not. While patients may question the class of drugs they are prescribed there is no evidence they are aware of who manufactures the particular brand of drug they are prescribed or reject prescriptions because of the manufacturers reputation.

More relevant to sales is the impact GSK’s actions may have had on public confidence in the medical profession who are the pharmaceutical company’s distribution channel. Prescribing behavior is the biggest driver of pharmaceutical sales. Loss of confidence in doctors represents a huge threat to profitability.
While in the past, increasing sales through providing incentives to doctors to prescribe has been a successful strategy, revelations about the prevalence and quantum of incentives to doctors has damaged public confidence in the integrity of the medical profession to the extent that GSK and its rivals have seriously harmed their own distribution channel.

We have seen this happen in other industries. A Deloitte survey of retirement advisers found that 20% of respondents didn’t trust advisors to provide objective advice and were concerned that they were motivated to guide them towards investments benefitting the provider rather than the client. The survey found that 83% of those who have a high level of trust in advisors sought their advice, compared with only 32% of those who have a low level of trust.

Given that doctors are the sole distribution channel for drugs, it is in the interests of pharma to ensure they are trusted by consumers and are not perceived as compromising their commitment to patient care as a result of their relationship with the pharmaceutical industry. Stopping payments to doctors and funding for medical conferences and severing the ties between sales rep remumeration and prescribing rates will be key to convincing consumers of the independence of doctors.

Marketing guru Kotler believes that strong brands are the only route to sustained, above-average profitability and that great brands present emotional benefits, not just rational benefits. Great brands work more on emotions than on product attributes and benefits and show social responsibility care and concern for people and society.
There is a niche in the market for a pharmaceutical company to become the leader in ethical practice. Branding is about perception rather than reality and it is not necessary for GSK to be ethical in reality but to create the perception of being so.

The recently announced changes in GSK’s business practices are, in my view, aimed at increasing confidence in the medical profession and positioning GSK as the ethical player in the pharmaceutical industry, they have nothing to do with requirements imposed by government.

Would The Real Ben Goldacre Please Stand Up?


Ben Goldacre is a doctor, journalist, blogger and writer whose media profile has risen exponentially over the past few years, particularly with the release of his last book on the pharmaceutical industry, Bad Pharma.  But who is the real Ben Goldacre- and what does he really stand for?

   Whilst Bad Pharma catapulted Ben Goldacre’s career firmly into the mainstream (and his trendy hip-doctor/guardian-journo persona seemed to capture the interest of the public imagination)- the content of Bad Pharma had more or less been covered already by other writers such as David Healy , Marcia Angell and others- over the years.

   Actually, most of the topics and issues in Goldacre’s book had also already been covered on this blog alone – predating the content of his book by five years ( I set up this blog in 2007- Bad Pharma was published in 2012).

   In other words- for a seasoned pharmaceutical industry critic, patient advocate, ex-Seroxat addict and blogger like me – what he had to ‘reveal’ about the badness and misdeeds of pharmaceutical companies was hardly revelatory at all. I could  have written it myself as I was certainly familiar with most of the information.

All that aside- what interests me most about Goldacre is his association with GlaxoSmithKline.

   Back in 2003- Goldacre received the GSK/ABSW award for his Guardian article ‘never mind the facts’. The article itself was basically a rebuttal piece in defense of MMR Vaccines and thus in turn- a defense of the pharmaceutical companies who make them and somewhat of an attack on those who claim that they can cause harm.

   I am no expert on vaccines or their link to Autism, nor would I ever claim to be- but I am well versed in pharmaceutical misdeeds- in particular those of GSK (I have been researching and blogging about GSK related issues for over 7 years now). I am aware that one of GSK’s vaccines, Pluserix was banned in 1992 and like other GSK medicines-  such as Seroxat and Avandia- not only was it causing immense harm- but GSK were allegedly aware of it.

  From my own experience of Seroxat- I would like to categorically state that I believe GSK were aware that Seroxat might harm me but like many instances with many other GSK products, they failed to warn- because all that matters to GSK is the health of GSK. Profit is the bottom line. Patients- like me- are merely collateral damage. However, considering that Goldacre is a psychiatrist (a fact he seems resistant to overtly publicize) maybe he just doesn’t care much for those who claim to be harmed by psychiatric drugs like Seroxat? Nonetheless- there is surely enough quackery and pseudo-science in Seroxat marketing which could keep a self-proclaimed quack-buster like Goldacre steeped in column inches for months.

   GSK have a murky history of malpractice and deception- their corporate history is littered with headline after headline of disturbing unscrupulous behavior. They are quite simply- pathologically sociopathic when it comes to harming the public. As a physician- I am surprised that Ben Goldacre would be so quick to jump to their defense- surely fraudulent clinical trials, intimidation of critics and widespread corruption resulting in damage to patients- would go entirely against the physician’s hippocratic oath?

Not so- it seems… in Ben Goldacre’s world.

Below is a picture of Goldacre receiving his BSW/GSK ‘science writers’ award from (none other than) GSK’s infamous Seroxat apologist Alastair Benbow (pictured right) in 2003. Apparently the award includes a 2000 pound bursary. (see link) http://www.badscience.net/2006/07/test-2/

6a00d8357f3f2969e2013485f7e002970c

Benbow was interviewed by BBC Panorama for their Seroxat documentaries and in (a diabolically delivered) defense of Seroxat he basically eventually admitted that Seroxat caused some children to commit suicide (after previously denying this in the Panorama documentary before it). Chillingly, Benbow seemed to think that this fatal side effect was almost inconsequential in the grand scheme of pharmaceutical depression treatment.

   The year Mr Goldacre was receiving awards from GSK for writing articles in favor of the pharmaceutical industry, was also the year that coroners in the UK were calling for a withdrawal of GSK’s Seroxat from the market (see here).

   2003 was also the year that (due to overwhelming evidence from the public) GSK were forced to abandon their no addiction claim about Seroxat. (see here)

   The year that Ben was posing with an award from a GSK funded initiative is also the year that the UK regulator banned Seroxat for under-18’s due to it’s propensity to make them suicidal- a sinister fact that GSK failed to inform the public of- for years. (see here)

 (Thankfully, for users of Seroxat, it was Ben Goldacre’s colleague- Sarah Boseley of the Guardian -who covered most of these stories)

   According to a tweet (screen-grab below) sent in 2010 in response to Seroxat Secrets, Goldacre, knows the’ Seroxat story well‘ and apparently he thinks it’s ‘vile‘. If this is the case then perhaps he would relay his opinion on Seroxat to his chum Andrew Witty because Mr Witty doesn’t seem to give a damn about Seroxat at all. If Goldacre really thinks that the Seroxat story is so vile- then why be so chummy with GSK?

gold

   Goldacre’s stance on pharmaceutical companies seemed to take a sharp turn with the release of Bad Pharma, which on the surface paints them in a very negative light. However, since most of the content of Bad Pharma had already been covered either online,  by blogs, in news-articles or in print form already- one would have to question whether it really had any negative impact at all on the reputation of the industry? Did it enlighten us to anything we did not know already?

   An insightful (albeit also complex) review of Bad Pharma from David Healy (not so bad pharma) seems to conclude that the problem with Bad Pharma rests not upon the repetition of content already covered, or the many flawed arguments raised which seem to rally against the pharmaceutical  industry but actually often work in their favor, “but on the premium Ben puts on controlled trials not found in other books”.

  You would have to read Healy’s review a few times to understand just how flawed and  -dare I say it- impotent –Bad Pharma is- particularly from a patient’s (or patient advocate’s) perspective. Perhaps it’s justified to ask- if a book highlighting the badness of Pharma actually serves to work in their favor in the long term- what use is it for the benefit of the public? Are we any safer? Possibly not.

   In a video of a parliamentary discussion of clinical trial transparency in the UK parliament from April 2013- Goldacre sits alongside GSK exec- James Shannon, and William Burns from Roche (19:06:00). In this inquiry, Goldacre refers to GSK as being ‘rather badly behaved‘ in the past- he then goes on to congratulate them on their current progress towards atonement (a fairy-tale like ‘atonement agenda’ which Goldacre seems to be swallowing hook-line-and sinker). The irony of this is- GSK have no intention of giving any access to clinical trials which predate 2000- therefore trials on drugs like Seroxat will not be released for inspection (Seroxat Trials pre-date the 90’s).

   I find Goldacre’s choice of words also quite astounding- ‘rather badly behaved‘ really doesn’t describe the destruction of life from a defective drug like Avandia or Seroxat.  “Rather badly behaved‘ doesn’t illustrate the magnitude of a 3 Billion dollar fine for fraud and corruption does it? “Rather badly behaved‘ is the kind of phrase we might use in regards to naughty children who won’t do their homework- not the UK’s biggest drug company (with the responsibility and power to enhance or extinguish human life on any given day depending on which way their ethical compass intends to sway). Goldacre then proceeds to  heavily criticize Roche and their Tamiflu debacle -conveniently leaving GSK looking much more ethical by comparison.

In an interview from March 2013– Goldacre says that he met Andrew Witty, CEO of GSK, before the announcement that GSK will release all trial data relating to its current products, with older data being released over several years. “He’d obviously thought very carefully about the practicalities of it, and that reassures me – he’d thought about how to do it, what the costs would be, and I think it’s to his enormous credit.”  Following the announcement Among one of many celebratory tweets, Goldacre said the news was: “Amazing. Fantastic. Historic.

   Thanking GSK for its decision, he added: “This is the beginning of the end for a dark era in medical history.” This ‘end of an era‘- and ‘the beginning of a new ethical GSK’ concept– has long been the mantra of Andrew Witty and GSK- particularly in regards to crimes that were committed prior to Andrew Witty’s tenture as CEO. I’m sure that GSK is delighted to have people like Goldacre championing (and echoing) its PR agenda- tweets from Ben Goldacre (with 250,000 followers) go far and wide.   Furthermore, these are just the perfect type of glowing PR sound-bytes that- pharmaceutical reputation management consultants- can’t even buy for GSK. Goldacre’s support must therefore be -utterly invaluable to them…

   And here we come back  again to Ben Goldacre and his association with GSK. At every given opening in the clinical trial transparency debate- it seems Ben Goldacre  just can’t resist an opportunity to lavish praise upon GSK CEO Andrew Witty. In an article from October last year (2012) he says:

“I think Andrew Witty, the current head of GSK, is a good guy, and I discuss this at length in the afterword of Bad Pharma: because I don’t realistically think that we can rely on one person in one company being nice, as a strategy to address ongoing regulatory failure in a global $600bn industry where lives are at stake.” (see here

   Perhaps Goldacre is incredibly naive, easily manipulated, under a spell, or utterly gullible? or maybe he genuinely does believe that GSK have changed their spots? I really have no idea

  However, considering that Andrew Witty has worked for GSK in various high level positions for most of his adult life I think it would be safe to assume that as CEO now he would have knowledge of most things that have – and do occur -within the company- including those things which would often undoubtedly come under the banner of big bad pharma

   And Ben… “good guys don’t become CEO’s of Billion-dollar Global Pharmaceutical companies”…

“You cannot hope to bribe or twist,
Thank God, the British Journalist,
For seeing what the man will do
Unbribed, there’s no occasion to.1

What is true cannot be minted

into a falsehood, even by

the most distinguished professor. 4

1 Anon.
4 Samuel Hahnemann.”

(Quotes Kindly Taken From http://www.whale.to/b/dwarfs01.pdf)

GSK’s Extensive and Long History of Corporate Misconduct… Bob Fiddaman Investigates..


And this is just the tip of the iceberg where GSK and bad deeds are concerned… 
Scary..

http://fiddaman.blogspot.ie/2013/09/gsk-runaway-trainrunning-right-off-track.html

Saturday, September 14, 2013

GSK – A Runaway Train…Running Right Off The Track

If there is one corporate company still operating when it really shouldn’t be that company that stands head and shoulders above any other I know is British based GlaxoSmithKline.No sooner had they been found guilty for a whole host of violations in the US [Resulting in an estimated $3 billion fine] they are back in the news again for yet more violations, this time in China.The Chinese violations are currently under investigation. GSK head honcho, Andrew Witty, has denied knowing about the shenanigans going on in China which include:

  • Bribing doctors with cash payments
  • Bribing doctors with sexual favours
  • Using a network of more than 700 middlemen and travel agencies
  • Inventing meetings that required travel payments (these payments were given to doctors to persuade them to prescribe GSK products)
Glaxo’s $3 billion fine in the US is just another piece of the jigsaw. Before this they have made settlements in and out of US Courts, paying defendants compensation and slamming down gagging orders as part of the settlements… in other words nobody can go public with amounts paid to them.
Let’s just take a look at some of the other violations committed by GlaxoSmithKline over the past few years.
Cidra
Glaxo’s Puerto Rico plant, Cidra, was infested with violations of federal rules and regulations with regards to the operation of the plant, which violations had a large and detrimental effect on the Company’s sale of Paxil (Seroxat) and Paxil CR.
A lawsuit was filed by Cheryl Eckard, who, at the time, was Glaxo’s Manager of Global Quality Assurance. (United States ex rel. Cheryl Eckard v. GlaxoSmithKline, Case No. 1:04-cv-10375-JLT (D.Mass. Feb. 25, 2004
Eckard was assigned by GSK headquarters in Research to lead a recovery team in Cidra after Glaxo had received a warning letter from the FDA regarding the abhorrent state of the plant. GSK had nine years to iron out the problems at Cidra… they didn’t.
After leading her recovery team Eckard found more violations that the FDA had missed first time round.
In a nutshell, she brought this to the attention of her senior managers, her managers ignored her… then fired her.
According to Eckard’s complaint: “persons at the Cidra plant were skimming product during manufacture, including reject product, and diverting the product to Latin America. … rejected batches of drug product, including Avandamet, were sent from Cidra to [MOVA Pharmaceuticals], (which is located near Cidra) for “black market” packaging and distribution …”
 
Nearing the end of the trial Glaxo said in a statement that it regretted the way it operated the Puerto Rico plant, which has since been closed, and it’s committed to continuously improvingmanufacturing quality. The company denied Ms. Eckard’s allegations, and said her lawsuit will be dismissed as part of the settlement and payout to her.
Glaxo were fined $750M and Eckard walked away with $96 million for her whistleblowing efforts.
No criminal charges were laid against Glaxo despite allegations of their involvement in selling on rejected batches of drugs to MOVA Pharmaceuticals.
Avandia
Glaxo suppressed patient-level meta-analysis of safety data from Avandia trials which demonstrated an estimate of excess risk of ischemic cardiovascular events and other potentially life-threatening complications.
A two-year investigation by the U.S. Senate Finance Committee revealed GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication.
During the first round of Avandia lawsuit settlements in May 2010, the company agreed to pay approximately $60 million to settle more than 700 cases. Later that year, GlaxoSmithKline agreed to a $460 million settlement, which resolved approximately 10,000 cases. In early 2011, as the first federal Avandia trials began, GlaxoSmithKline agreed to pay a reported $250 million to settle 5,500 claims that Avandia had resulted in death.
In 2012, after being ordered to pay $90 million to resolve allegations by prosecutors in 38 states that the they illegally marketed Avandia, Glaxo had this to say:
 “The company did not admit to any wrongdoing or liability of any kind under these states’ consumer protection laws in this settlement” 
 
 
Paxil (Seroxat) Birth Defects
 
After deliberating for seven hours, a state court jury in Philadelphia found that GlaxoSmithKline failed to properly warn doctors and pregnant women about risks associated with Paxil. The jury awarded $2.5 million in damages to the family of Lyam Kilker, who was born with heart defects after his mother took Paxil during her pregnancy.
The case was the first to go to trial of more than 600 suits claiming that Glaxo hid knowledge of birth defect risks allegedly tied to Paxil.
What did Glaxo have to say after being found guilty?
“While we sympathize with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition.” 
You’ll probably find that the jury thought otherwise Glaxo.
Paxil (Seroxat) Suicide
On December 14, 2009, Bloomberg published an article entitled “Glaxo Said to Have Paid $1 Billion in Paxil Suits.” 
The article reported:
GlaxoSmithKline PLC has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.
Why did they do this?
Well, it’s down to the Schell case in 2001.
Donald Schell, 60, had been taking Paxil for just two days when he shot and killed his wife, his daughter, his granddaughter and then himself.
Remaining members of the family filed suit.
During the trial GSK [then SmithKline Beecham] internal documents showed the company was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging didn’t, at the time, include a warning about suicide, violence or aggression.
Glaxo were found guilty and ordered to pay $6.4 to the remaining family members.
What did Glaxo attorneys say after this particular defeat?
“Paxil is a very effective medication in helping depression,” attorney Charles Preuss said after the trial. “Our only regret is that Mr. Schell did not have Paxil for a longer period of time.” [Link]
 
The link between Paxil and suicide has been raging for years.
Here’s what former Head of Psychiatry at GlaxoSmithKline, Alistair Benbow, had to say in a BBC interview.
Benbow {A} was being interviewed by investigative journalist Shelley Jofre.{Q}
Q. Let us move on. What has the company done about the Wyoming (Schell) verdict?
A. As I told you before, in this matter because of a confidentiality agreement between the family and GSK I am not able to specifically comment on the mitigation, but what I can say is that there is no reliable clinical evidence that Seroxat causes violence, aggression or homicide. This tragic, tragic case is something that does occur from time to time in patients who are depressed…
Q. This man had no history of suicidal thoughts or tendencies. The jurors sat and listened to all the evidence and decided that there were four deaths that were mainly caused by Seroxat. Your company was found guilty of negligence. You cannot ignore that.
A. No, and nor would we want to ignore it. This was a tragic case but we remain firmly convinced that Seroxat did not cause the tragic events in this case.
Again, I think the jury would disagree with Benbow here.
If Glaxo believed their product was innocent in the suicides of these people why would they settle further cases? One such case involving the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hanged himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.
They then settled with the family later.
Paxil (Seroxat) Addiction
In its 2008 annual report, Glaxo officials said they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.
In other words a gagging order was place. This enables Glaxo to defend any further lawsuits regarding Paxil addiction. One such lawsuit is the UK Seroxat litigation which Glaxo are defending.
The UK lawsuit has been dragging on for over 10 years now. Glaxo have refused to make any such compensatory settlements to any UK citizen.
So, just a few reasons why it comes as no surprise to learn that Glaxo have been behaving badly in China. No surprise that Witty is denying any knowledge of what went on in China either.
Even when found guilty Glaxo continue to deny any wrong-doing… that trend will continue until compensation is put to one side and criminal charges are laid against the top executives at Glaxo. They are the past masters of buck-passing, of laying blame on others, of waving wads of cash [dangling carrots] in front of victims in the hope that a settlement can be reached. With settlement comes suppression and Glaxo just love suppression.
I anticipate that the bad behaviour in China will be settled and those responsible [the top management] will deny knowledge and let the area managers take the fall.
That’s their style, always will be until someone has the balls to come down hard on the senior management at GlaxoSmithKline.
Someone really needs to put a stop to this runaway train.
Bob Fiddaman