right on the money…

Posted on Thursday 12 September 2013

Like many others, a few days ago I wrote a deal-breaker?…, a post about AbbVie’s lawyer, Neal Parker, who appeared at the Brussels Conference, A Roadmap for Sharing Clinical Data. Among other things, he said:
… internal tactical decisions on how we are going to run a study, engage with regulators, and confront and solve problems and challenges we have uncovered during clinical trials… This information cannot be patented nor have exclusivity, but can give other companies a tremendous competitive advantage by revealing our strategic thinking for proving safety and efficacy of our products.
Since then, I’ve felt kind of numb. I’ve watched the video multiple times; written some things about it; and read what other people had to say; but none of that captures the numbness. Mr. Parker either intentionally or inadvertently redefined the drug approval process as a negotiation whose outcome was determined by "our strategic thinking for proving safety and efficacy of our products." The "trade secrets" aren’t in the products. They’re in the expertise of the trader. This review of a new book by Peter Gøtzsche, the head of the Nordic Cochrane Centre, entitled Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare comes close to defining my feeling:
BMJ Group Blogs
by Richard Smith, former editor of the BMJ
September 10, 2013

… Most of Peter’s book is devoted to building up the case that the drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs. As an epidemiologist with very high numerical literacy and a passion for detail, so that he is a world leader in critiquing clinical studies, Peter is here on very solid ground. He joins many others, including former editors of the New England Journal of Medicine, in showing this corruption. He shows too how the industry has bought doctors, academics, journals, professional and patient organisations, university departments, journalists, regulators, and politicians. These are the methods of the mob.

The book doesn’t let doctors and academics avoid blame. Indeed, it might be argued that drug companies are doing what is expected of them in maximising financial returns for shareholders, but doctors and academics are supposed to have a higher calling. Laws that are requiring companies to declare payments to doctors are showing that very high proportions of doctors are beholden to the drug industry and that many are being paid six figures sums for advising companies or giving talks on their behalf. It’s hard to escape the conclusion that these “key opinion leaders” are being bought. They are the “hired guns” of the industry.

And, as with the mob, woe be to anybody who whistleblows or gives evidence against the industry. Peter tells several stories of whistleblowers being hounded, and John Le Carré’s novel describing drug company ruthlessness became a bestseller and a successful Hollywood film.

So it’s not entirely fanciful to compare the drug industry to the mob, and the public, despite its enthusiasm for taking drugs, is sceptical about the drug industry. In a poll in Denmark the public ranked the drug industry second bottom of those in which they had confidence, and a US poll ranked the industry bottom with tobacco and oil companies. The doctor and author Ben Goldacre, in his book Bad Pharma raises the interesting thought that doctors have come to see as “normal” a relationship with the drug industry that the public will see as wholly unacceptable when they fully understand it. In Britain doctors might follow journalists, members of Parliament, and bankers into disgrace for failing to see how corrupt their ways have become. At the moment the public tends to trust doctors and distrust drug companies, but the trust could be rapidly lost…

It’s not about the cards, but about the poker player’s skill at the game. And a major part of that skill relies on the hidden cards. That’s what Peter Gøtzsche is talking about. It’s the "organized" in organized crime – refining those techniques behind a curtain of quaisi-legitimacy. There was a time when I would’ve thought Peter Gøtzsche’s analogy was melodramatic and fanciful. Not any more. And then there’s this from the EFPIA [European Federation of Pharmaceutical Industries and Associations], sponsors of the Roadmap for Sharing Clinical Data conference:

Brussels – [September 5, 2013] – Representing the research-based pharmaceutical industry in Europe, EFPIA and its member companies welcome efforts towards greater transparency of clinical trials data. However EFPIA has serious concerns about the EMA draft policy [Policy 0070 on publication and access to clinical trial data], which carries negative implications for public health in its failure to adequately protect the interests of patients and the research they benefit from. In the interests of sharing its concerns with all relevant stakeholders as well as the general public who will be impacted by these measures, EFPIA is today making publicly available its comments on the EMA submission.

Director General of EFPIA, Richard Bergstrom, stated: “We are worried by a move towards greater transparency of clinical trials data that appears to be putting transparency – at whatever cost – ahead of public health interests. Our detailed response to the EMA draft policy speaks to this concern. While EFPIA values other voices and opinion in the conversation surrounding clinical trials data, we believe there are better alternatives than what the EMA is presenting."

The EFPIA-PhRMA Joint Principles for Responsible Clinical Trial Data formally announced July 24 and going into effect January 1, 2014, outline a responsible transparency that safeguards patient privacy; respects the integrity of regulatory systems; and maintains incentives for investment in biomedical research. A transparency built on these pillars offers the protective measures for patients and research that ultimately will best serve patients and broader public health needs.” EFPIA’s response to the EMA draft policy focuses on three primary concerns, specifically that the EMA approach, as it stands, will:
  1. Weaken safeguards intended to ensure the privacy of patients and other individuals identified in marketing authorization application [EMA] dossiers;
  2. Undermine the trust in the regulatory approval system governing biopharmaceutical products and introduce risks of misinterpretation and misuse of clinical data into the process;
  3. Weaken incentives for companies to invest in biomedical research by disclosing companies’ commercially confidential information [CCI], without due consideration of the competing interests that may or may not justify disclosure.
The specific points addressed by EFPIA in its response to the EMA draft policy, and an Executive Summary overview, are available on the EFPIA website, as well as its dedicated transparency platform. The EMA public consultation remains open for comments until September 30.

A month ago, I summarized the prequel to this release in full speed ahead…:
I smell a strategy coming from PhRMA about this business of AllTrials and RIAT. Two recent articles address the public version. In do the time…, I looked at GSK’s white paper in the New England Journal of Medicine [available via Medscape’s write-up GSK Opens Access to Data From More Than 200 Clinical Trials]. Later, in the spice must flow…, I reviewed the head-to-head article from PhRMA in the British Medical Journal [Are clinical trial data shared sufficiently today? Yes]. The private version comes from the leaked memo reviewed in a closing argument… which includes an article from the Guardian [Big pharma mobilising patients in battle over drugs trials data], a retort in eye·for·pharma [Exclusive: The Devil is in the Details], and the actual memo from EFPIA & PhRMA.
So far, writing this has been good treatment for my numb feeling [which I suspected was a defense against rage]. That was confirmed when I almost involuntarily highlighted that part of their release in red – "introduce risks of misinterpretation and misuse of clinical data into the process." That’s an outrageous thing for them to say after so many Clinical Trial reports in our literature that regularly make mincemeat out of scientific interpretation.

I doubt that my rage makes much of a dent in their battle plan which is what this really is. Like Mr. Parker’s "internal tactical decisions" and "strategic thinking," these arguments are carefully constructed to move the unreasonable label from their folder and stamp in on the data transparency dossier and the EMA itself. There is one interesting thing of note. They don’t mention the motives of the EMA or the advocates of data transparency – a usual ploy in such maneuvering. I expect that’s because they couldn’t think of anything to say. The motives of the EMA are self evident and intrinsically valid.

And as for their bullet points, I don’t think any of us care about "other individuals identified in marketing authorization application [EMA] dossiers." Anonymize them too. I’ve commented on their Number 2 already. Number 3 is their business, not the EMA’s. Their "internal tactical decisions" and "strategic thinking for proving safety and efficacy of our products" is as much a part of the problem as anything else. Looking to the EMA to protect their poker game is an insult. And as for the blackmail clause ["Weaken incentives for companies to invest in biomedical research by disclosing companies’ commercially confidential information [CCI], without due consideration of the competing interests that may or may not justify disclosure"], we doctors and patients will limp by with the medications we already have and any legitimate entries that come along until a rational and transparent pharmaceutical industry emerges. No problem. I would welcome the opportunity.

I guess I knew about the rage under the numb feeling. There’s another part that wasn’t quite so obvious. After listening to Mr. Parker and reading the EFPIA press release, I don’t think they’re really going to negotiate in good faith, no matter what they say – ever. They’re going to just keep strategizing. Peter Gøtzsche is right on the money, and we’re in for a long struggle with some very moneyed people…
    Steve Lucas
    September 12, 2013 | 2:30 PM

    I have been looking for an old Health Care Renewal post showing a drug rep that became a Playboy model and then appeared in a reality show, no luck. I was able to find the link below, while old and I am sure the links do not work, indicates what pharma thinks of doctors.

    Flashy happy girls with no medical education or product knowledge:


    Really does fit the image of a mobster surrounded by attractive women.

    Steve Lucas

    September 12, 2013 | 5:01 PM

    At least the links to the original NYT article and the company that recruits cheerleaders in the Health Care Renewal post noted by Steve Lucas above still work.

    Note that we just posted about the AbbeVie and Intermune lawsuit here:

    September 12, 2013 | 10:45 PM

    Watching the whole video, I couldn’t help but feel that Neal Parker was the wolf at the front door, and Bergstrom from EFPIA, the EU Pharma guy, was the fox slipping round the back door (which is how Malcolm X once put it, adding that he’d rather deal with the fox!) You are dead right Dr Mickey, their “Road Map” offers us nada, zip, zilch. Pharma gets to decide what’s confidential, what’s relevant, what patients need to be protected from and who gets in to guard the chicken coop.

    If GSK is really so committed to transparency … well, they are members of EFPIA and PhRMA too, aren’t they? So are they ready to dissociate themselves from AbbVie’s disastrous lawsuit (which EFPIA) supports) and from EFPIA’s Road Map to Nowhere, for starters? If not, why are they getting all this acclaim, being allowed to sign on to the AllTrials petition, etc. etc.?

    At least ol’ Parker is letting the mask slip a bit, showing us the real face of his industry.

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