By Tom Jefferson, Cochrane Collaboration
With billions to be made on the back of ill health and notable scandals and cover-ups in its history, it’s fair to say that many see the public face of the pharmaceutical industry as a mask for darker machinations. We rely on the drugs for myriad conditions, but do we trust big pharma?
Pharmaceutical giant GlaxoSmithKline (GSK) is no stranger to accusations of unethical drug marketing tactics. But recent news coverage has included its support for the AllTrials campaign – which calls for clinical trials to be registered and results to be published – and a package of other initiatives, including a new commitment to end direct payments to doctors and other key opinion leaders (KOLs) that have been one of the industry’s most powerful marketing tools.
Last year, the company received a record-breaking US$3 billion (£1.9 billion) fraud fine meted out by the the US Department of Justice after pleading guilty to promoting two antidepressant drugs Paxil and Wellbutrin for unapproved uses such as treating children. It was found guilty of paying kickbacks to doctors.
US attorney Carmin Ortiz said: “The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts.”
Andrew Witty, GSK’s chief executive, said the company had “learnt from the mistakes”. And some might see recent efforts as an attempt to clean up its act.
GSK announced via a carefully worded release that by 2016 it would no longer be directly funding speaking engagements or attendance at medical conferences for KOLs. This has been widely interpreted by media and commentators as signalling the end of the use of KOLs by GSK.
While GSK wants to “support fair, balanced and objective medical education for healthcare professionals through provision of independent educational grants” it also “will move to end the practice of paying healthcare professionals to speak on its behalf, about its products or disease areas, to audiences who can prescribe or influence prescribing”.
So far so very good on the surface, especially since GSK “instead will fund education for healthcare professionals through unsolicited, independent educational grant routes”.
The wording can be taken at face value or it can be taken to mean that indirect sponsorship of certain scientists will continue and since it is unsolicited, GSK will choose the lucky recipients. If so, on what basis will the choice be made?
GSK intends carrying out a consultation on how it should do this, starting in 2014 with view to a working policy by 2016.
In medicine, KOLs are people (usually physicians) who carry sufficient national or international weight to exert influence on what governments and the profession view as threats to health and the appropriate responses. Their influence can and does make an impact. But without knowing other interests, how do we know they are acting in the public interest?
In 2009, we started critically reviewing work on the blockbuster anti-influenza drug Tamiflu (oseltamivir) by the drug company Roche. We asked four authors of Tamiflu publications based on clinical trials carried out a decade before to clarify aspects of their publications. None could answer our questions.
These were not just any old clinical trials. The publications (in very prestigious journals) provided the rationale for the statements that Tamiflu could help with health complications caused by influenza. We now know that this statement is not based on credible evidence – but at the time it led to stockpiling of the drug in many countries at great public expense, which is continuing to cost us dearly to this day.
Later media inquiries revealed that the four doctor-researchers had not seen the raw data in the articles and some of them had been written by ghost writers. The ghosts had received summary tables with key messages, straight out the Roche marketing department. In one extreme case the results of the biggest trial of Tamiflu ever conducted were summarised in a conference abstract which bore the name of a US academic who could not recall ever having anything to do with the trial (which is still unpublished).
When Roche were asked who had presented the abstract at the conference they responded: “It’s not infrequent that you may have somebody who authors but they don’t actually present it at a conference, it depends upon their availability.”
Most of the academics involved were responsible for writing the first WHO guidelines on how to respond to an influenza pandemic. It is not surprising that Tamiflu use featured prominently. In addition we now know that UK government advisers who were linked with big pharma were the ones who made significantly more dire predictions of the impact of any influenza pandemic.
Thankfully this issue is now being picked up by a group of UK MPs who published a critical report that said doctors and others weren’t able to make proper decisions about Tamiflu because the drug company had not published full information from clinical trials. But who in government were taking these decisions? There will be yet more to come out of this.
But the story illustrates the role and importance of KOLs to industry. KOLs are able to persuade governments, healthcare workers and the public that a health problem should be viewed as a serious threat and are able to build consensus on the “right” treatment.
Most KOLs are not so by chance, they are spotted early by media relations companies and carefully groomed to enter a world of congresses, high-visibility publications and glittering careers. Some are convinced of their scientific prowess and objectivity, but others are less sure that the world of make-believe, carefully packaged messages and – of course – cash, is consistent with the ethos of their profession.
Most join “speakers’ bureaus” in which (as we have seen) they are assigned talks, presentations or just presence to suit and support a particular marketing strategy.
And it’s common practice – Roche, Novartis and GSK. But now GSK says it is pulling out.
Cynics refuse to believe that big pharma is planning to do away with one of its most powerful tools, I would suggest that readers make up their own mind by following the story as it evolves.
Whichever tack you choose, be like me: do not trust anything you hear or read, but ask, ask, ask.