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March 2010

Whose bread I eat, his song I sing

by Julian Burnside QC

Julian Burnside is a prominent Australian barrister. In 2009 he represented the lead plaintiff in a class action against Merck concerning the effects of Vioxx. This is an excerpted version of the keynote address he gave at the Royal Australian and New Zealand College of Psychiatrists Congress in Adelaide on 28 May 2009.

(Click here to read an unedited transcript of this address - .pdf 127 Kb.)

An ABC television program called Media Watch keeps an eye on what happens in Australian media.  In 1999 Richard Ackland was the anchor of the program.  He drew attention to something which had been happening on the John Laws Radio Program.  (Until he retired very recently, John Laws dominated the Sydney and rural airwaves with talk back radio.)  Laws was famous amongst other things for his relentless beating up of Australian banks, but Richard Ackland drew attention to the fact that, recently, John Laws had started telling good news stories about them.  Subsequently, Richard Ackland revealed that Laws had reached a sponsorship arrangement with the Australian Bankers Association worth 500,000 dollars a year.  The quid pro quo was that he would run a number of spots on his show called The Whole Story in which he would tell interesting little historical anecdotes which would be known in part and then he would tell you the balance of story, giving you “the whole story”.  He would accompany that with a parallel yarn about how we have only heard half the story about the banks, and these stories placed the banks in a very favourable light.  This approach managed to negate a great deal of the beating up of the banks that he had previously engaged in.
Richard got quite excited about this as it seemed quite odd that John Laws would take money from the banks and then start embracing their views.  The Australian Broadcasting Authority decided to hold an enquiry into this and its initial investigations into the matter revealed the fact that the other king of talkback radio station, Alan Jones, was also on the drip with a few companies to whom he had recently been relatively benign.  I was briefed to act for the Australian Broadcasting Authority in the public hearings into the matter.  During my opening remarks at the hearing, I spoke of the old Irish aphorism:  Whose bread I eat, his song I sing.

The enquiry uncovered amongst other things that Jones had a $500,000 a year contract with Optus, $433,000 a year contract with the Colonial State Bank, $250,000 a year contract with the Walker Corporation and a swag of others.  John Laws was getting $895,000 a year from Optus – incidentally,  it provoked a bit of rivalry between them when each discovered what the other was getting.  Laws was getting $300,000 a year from Foxtel, a couple of hundred thousand a year from Qantas plus 6 first class tickets to any destination in the world and a handful of others.  Both of them doing incredibly well. 

John Laws gave evidence at the hearing that he wasn’t paid to be influenced or to change his mind but the recorded fact is that he stopped beating up on the banks. What conclusion you can draw from that is a matter for you.  They both insisted from first to last that their comments on air and off air were completely unaffected by the sponsorships of the sorts that were revealed.
So that defined the fighting ground, and when you think about it the response of each of them was perfectly understandable, probably genuine, probably sincerely held, probably the sort of reaction that every person in this room would hold when asked in some form or another: Would pharmaceutical company sponsorship influence the way you see things?

Now everything has a background and in 2007 I heard a wonderful Ockham’s Razor on Radio National, given by Christopher Nordin.  It got me thinking about pharmaceutical company sponsorship, which is something I haven’t really attended to before. 

More recently I have been involved in some really exciting litigation against Merck Pharmaceuticals in relation to their drug, Vioxx, which I might mention a little later on.  One thing becomes clear, and that is that big pharma spends a lot of money to influence your thinking. 

Now some facts. The pharmaceutical industry is very profitable.  The combined profits of the top 10 drug companies on the Fortune 500 list is 35.9 billion US dollars.  That is more in total than profits of all of the remaining 490 companies in the Fortune 500.  They have research and development that amounts to about 11% of their budget but their marketing amounts to 36% of their budget.  In 2001, a United States pharmaceutical company spent more than $4.8 billion on sales personnel targeting medical practitioners.  They spent more than $2 billion US on conferences, seminars and other practitioner-oriented events.  They spent more than $10 billion providing drug samples free of charge to physicians. 

In Australia, although the scale is smaller, a study of Australian practitioners revealed that 96% of practitioners had received offers of food from pharmaceutical companies, not food handouts but nice dinners.  94% of them received products they could use in their office, 51% of them received personal gifts.  50% received journals or textbooks.  Between 75% and 85% of them were invited to product launches, symposia or other “educational events”.  More than half of them received offers of free travel to conferences and typically those offers would include free transport for the partner of the practitioner, gift tickets to sporting events and other entertainment.

Nevertheless, reports in learned journals indicate that physicians deny or are unaware that they are influenced in any way by pharmaceutical spending.  The effects of sponsorship however are at the heart of the issue.

Drug companies sponsor a great deal of research, and no doubt a good deal of that research has very useful outcomes.  Nevertheless the reports show that the drug company sponsored research is four times as likely to have an outcome favourable to the sponsor than research that is independent.

Authors of company-sponsored research are more than five times more likely to recommend the drug company’s products than are independent authors.  Researchers with industry connections are more likely to favour the products of the company that sponsor them.  An Australian survey revealed that over 12% reported that industry staff wrote the first draft of articles published under the names of the medical specialists.  Between 5 and 7% reported that unfavourable findings were either delayed or censored out of the reports, which were supposedly written by the authors.  A smaller number reported complete concealment of adverse results. 

Another area of influence, which must be particularly difficult to resist, is the use of Key Opinion Leaders.  My involvement in the Merck trial introduced me to this notion.  Key Opinion Leaders are the medical profession’s equivalent of talk back radio hosts.  They are the people whose voices are powerful and there is no doubt whatsoever that the pharmaceutical industry courts them, flatters them, coaxes them and nourishes them with feelings of goodness and virtue expecting that they will pass on favourable messages about the sponsor’s products.  The amounts which they spend on this are enormous, and one can only assume that they do it because they think it works. 

Key Opinion Leaders might reflect on this question: why do you imagine you are being flattered and groomed by pharmaceutical companies?  And when you pass on good messages about their products, are you confident that it is your view that you are passing on, or have you been influenced to some extent by the flattery and the money, the travel and all the perks?  I don’t have a view about whether or not people are able to withstand completely the blandishments that Key Opinion Leaders are subject to. I rather doubt it, as I come from a much frailer area of humanity than you do.

Equally I would be fascinated to know from you, especially as psychiatrists, why it is that we can all see these things and yet Key Opinion Leaders continue to be Key Opinion Leaders.  If everyone knows that these things happen, why does anyone listen to the people they think are necessarily affected by a drug company’s sponsorship?  Why are they opinion leaders at all, if you have the sense they are just peddling drug company’s products, albeit unwittingly? 

Another indirect way that drug companies influence opinion at the grass roots is through the learned journal.  The New England Journal of Medicine for a long time had a stringent policy restricting, or declaring, possible conflicts of interest of authors in the journal.  For 12 years it had a policy which precluded anyone with financial ties to the pharmaceutical industry from writing editorials or reviews.  In about 2002 they scrapped this policy because it was too difficult to find anyone to write editorials.  They could not find enough authors without ties to the pharmaceutical industry.  That fact alone tells you something remarkable about how pervasive is the influence of the industry.

Richard Smith, Editor of the British Medical Journal in an article titled ‘Medical Journals and Pharmaceutical Companies – Uneasy Bedfellows’ wrote in 2003 “How did we reach a point that so many doctors will not attend an educational meeting unless it is accompanied by free food and a bag of goodies?  Something is wrong and medical journals are a part of what is wrong.” 

“The industry dominates healthcare and most doctors have been wined and dined by it.”

I wonder, is there anyone in this room who has not been wined and dined, at least once by a pharmaceutical company.  He also said that the randomised clinical trial is being debased for marketing reasons.  He went on to suggest ways the pharmaceutical companies influence clinical trials and achieve the results that they want from clinical trials.  First test your drug against a treatment known to be inferior.  Next test your drugs against two lower doses of a competitor drug.  Alternatively test it against two higher doses of an alternative drug to make your drug seem less toxic.  Conduct trials that are too small to show differences from competitor drugs.  Select for publication those end points that give favourable results and select for publication results from centres that are favourable and information from those subgroup analyses that are favourable.

All of this I think can be seen if you look hard enough at the way clinical trials have been conducted and reported.  I am not saying this is a universal truth but it is sufficiently widespread that you need to be alert to it.  And the matter goes one layer deeper, when it was revealed during the Merck litigation that an apparently respectable, apparently independent, apparently learned peer review journal, The Australasian Journal of Bone and Joint Medicine was wholly produced by Merck and only ran articles and reviews that ran directly or indirectly in favour of Merck products.  In addition it had listed as its editorial board a number of people, Merck’s own advisory board, who didn’t realise they were on the editorial board of the Journal.  There was an email exchange between one of the Merck people and someone at Elsevier, who were the publishers of the Journal,  in which the Merck person said “We own the journal” and yet this was a journal to all outwards appearances entirely independent of any pharmaceutical company.

Whether there are other examples of the same phenomenon, it is difficult to know.  I guess you need to be on the look out.
Let me tell you briefly about the Merck litigation.  Merck produced a drug called Vioxx. Vioxx is supposed to be very good for relief of arthritis pain.  In 1999 and 2000 Merck had run a randomised controlled trial of Vioxx versus naproxen. Naproxen was a traditional NSAID which was associated with fairly bad gastric upsets, as many NSAIDs are.  The point of the trial was to demonstrate that Vioxx was free of gastrointestinal problems.  It was a big trial, well conducted and the results were exactly what Merck wanted, at least in part, because it showed that patients on Vioxx had far far fewer gastrointestinal problems than people on naproxen. 

There was a flip side however and that was that people on Vioxx had 5 times as many myocardial infarctions as people on naproxen.  Now that was rather inconvenient and there was a flurry of activity within Merck in March of 2000. They eventually released the report of the trials that said that Vioxx is brilliant for gastrointestinal problems, it reduces them dramatically, and naproxen subjects had fewer myocardial infarctions because of naproxen’s potent anti-platelet effect.

For the next 4 years Vioxx was sold on the footing that it did not cause adverse cardiovascular outcomes because the trial results were explained by the powerful anti-platelet or anti-thrombotic effect of naproxen.  This attributed to naproxen a cardio-protective effect even greater than that of aspirin.  The wheels fell off when a later placebo controlled study showed that Vioxx was actually producing twice as many heart attacks and other cardiovascular events than placebo. 

Now what is interesting about this was that the naproxen explanation was run as the explanation.It was pounded into the heads of the Key Opinion Leaders who were sent out like willing troops to convey the message, and Les Cleland from this city was vilified and scorned when he came out with the heresy that naproxen could not possibly be as cardio-protective as was necessary to explain the results in the clinical trials.  He was one of the very few dissenting voices. 

After the results of the placebo-controlled trial, Vioxx was voluntarily withdrawn worldwide.  A US senate enquiry was held and Senator Waxman, who ran it, later wrote an article about it in the New England Journal of Medicine which included these observations:

• On 7 February 2001 the arthritis drugs advisory committee of the FDA met to discuss VIGOR (the Naproxen trial). 
• Merck argued that the significant increase in myocardial infarctions which was five fold was explained by the effect of naproxen. 
• The medical reviewers voted unanimously that these cardiovascular adverse events had to be reported to physicians.
• The next day Merck sent a bulletin to its Vioxx sales force of more than 3,000 reps ordering them do not initiate discussions on the FDA Arthritis Advisory Committee or the results of the VIGOR Study.  They then produced a cardiovascular card which was given to all their reps, the point of which was to say there is no cardiovascular risk with Vioxx - the results of VIGOR are explained completely by naproxen’s powerful anti-platelet effect.

That was something about which the manufacturers of naproxen had never heard, and something that which would have been immensely beneficial for them because it showed naproxen to be twice as effective in cardio-protection as low dose aspirin.  The only people in the world to think naproxen was cardio-effective were Merck and their Key Opinion Leaders, and it kept Vioxx on the market for the next 4 years. 

Waxman also reported that the pharmaceutical industry in America spends more each year marketing its drugs than all American medical schools together spend educating doctors.  It is a very striking fact.  It seems to me that people who receive support from pharmaceutical companies are very likely to be influenced, unconsciously or not, by the levels of support they get, and the greater the support, the greater the degree of influence.  The question arises: are the pharmaceutical companies doing this out of altruism or are they doing it for plain commercial motives? 

One document produced in a Merck trial, passing between senior people within Merck, is an email with a subject line ‘Physicians to neutralize’:

“As we discussed attached is the list of ‘problem’ physicians that we must, at a minimum, neutralize…  We’ve had many opportunities to get these individuals involved including (lists examples of research, national consultants meetings, grants, CME program faculty training, medical school grants, personal contacts, peer to peer interactions, spend a day at headquarters and other consulting activities.)  We’ll keep these individuals top of mind for any upcoming programs and activities…”

If you are offered a grant, it may be that you are regarded as someone who needs to be neutralized. At the very least pharmaceutical companies are willing to offer grants to people who they think need to be neutralized or brought on-side.  Big pharma obviously think that this approach works.  If they think it works and they spend so much money on it then you need to be a bit more alert, perhaps, than you might have been. 

Ultimately, the question is: Are they fooling themselves or are they fooling you?  They are selling; are you buying? 

I started with an Irish proverb, let me finish with an Arab proverb: “The camel driver has his projects, the camel has his projects.”  If the pharmaceutical company is the camel and you are the camel driver, you must ask is it right to accept their sponsorship.  Thank you.




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