Monday, July 22, 2013

Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity

I had guessed that this sort of thing was going on all the time, but being kept very well hidden.  Now we have some more evidence.

An article in yesterdays Guardian showed how the pharmaceutical industry is using pet patient advocacy groups in a public relations campaign to defeat calls for for measures against suppression and manipulation of clinical research. In summary,

The pharmaceutical industry has 'mobilised' an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.

More specifically,

The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.  The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee.

The email describes a four-pronged campaign that starts with 'mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.

The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database.

The argument for continuing to allow clinical trials to be suppressed was to be,

The patient groups focus on the concern that if companies release all of their clinical trials data, the information might be misconstrued, or intentionally cherry-picked, and spark damaging health scares around certain drugs or vaccines.

The Guardian story did not disclose which patient groups were cooperating with this effort.

By the way, the other parts of this strategy involved using scientific associations and academics to push the pharmaceutical companies' agenda,

 Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. The final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. 
Several of the large multinational drug companies contacted by the Guardian issued the usual non-denial denials

In response to queries from the Guardian, GSK said: 'This is not something we are doing. One of the reasons we're involved in this is we want more companies to move towards greater transparency. I don't think it's for us to be mobilising patient groups to campaign on a negative level.'

A Roche spokesperson said the company consulted patient groups to understand their concerns about clinical trials, but 'to our knowledge Roche has not been involved in any EFPIA's potential activity in mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'.

A Lilly spokesman said: 'Lilly is committed to working with Europe-based patient advocacy organisations for the benefit of patients in a way that is true to the EFPIA code of practice and Lilly's integrity in business policy.'


We have long discussed and decried how vested interests, chiefly health care corporations with services and products to sell, have manipulated clinical research to make their wares look better, and suppressed research whose results, even if manipulated, could not be made sufficiently favorable. This has resulted in making drugs and devices look more efficacious and/or less hazardous than they really are.  See this post for our latest discussion, and information on the latest effort to counter suppression and manipulation of clinical research.

It is not surprising that pharmaceutical companies do not want to have to publish every clinical trial they sponsor, or expose their manipulations of these trials.  Instead, the Guardian article suggests that companies and their trade associations, including the US based pharmaceutical trade association, and several large US companies, and well as large companies based elsewhere, are using a third-party public relations strategy.  Wendell Potter's muckraking book on the US commercial health care insurance industry, Deadly Spin, revealed how similar strategies were used by US based health insurance companies to defeat the Clinton administration's attempt at health care reform, and other measures targeted to make the US commercial health care insurance system more equitable and ethical  (see post here).  Third party strategies are fundamentally deceptive.   

The current alleged use of the third party strategies by pharmaceutical companies to support ongoing suppression and manipulation of clinical research is more than just deceptive.  It is corrupt.

Patient advocacy groups are usually believed to represent patients' interests.  For such groups to support a public relations campaign that could allow ongoing harm of patients (by suppressing and manipulating evidence to prevent it from being used to forestall excess use of ineffective, dangerous drugs) is abuse of their entrusted power.  To do it for money, money used to support these groups, or help underwrite generous compensation for their executives, fits the definition of corruption used by Transparency International - abuse of entrusted power for private gain.

Note that the Guardian provided this viewpoint,

Tim Reed, of Health Action International, a group that has previously exposed the pharmaceutical industry's financial links with patient groups, said: 'It's incredibly ironic that this is a transparency initiative and we've now got clear indications that the pharmaceutical industry is ready to use patient organisations to fight their corner.

'It underlines the fact that patient groups who are in the pay of the pharmaceutical industry will go into battle for them. There's a hidden agenda here. The patient groups will say they think it's a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry.

'Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we're not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials,' he added.

We have previously noted isolated examples of evidence that particular US based patient advocacy groups were being supported by commercial firms presumably to aid their marketing.  We have also found examples of conflicts of interest affecting medical societies, and many affecting non-profit hospitals and academic medical institutions, and their staff and faculty.  I begin to wonder if most health care non-profit organizations in the US, and now it appears maybe in UK and in Europe, have been paid off to support marketing and/or public relations interests of health care corporations.

This latest example suggests that health care worldwide has become deeply corrupt, even more corrupt than Transparency International's Global Report on health care corruption in 2006, or the those responding to Transparency International's global corruption survey in 2013, could envision.

I only hope that the pile up of new examples - each seemingly worse than the one before - of health care corruption, will be sufficient to overcome the anechoic effect, and create enough global outrage to give us a chance to clean up our corrupt health care before it destroys our health.

ADDENDUM (25 July, 2013) - See also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. 

ADDENDUM (29 July, 2013 - See the comment on the 1BoringOldMan blog. 


Anonymous said...

Well, these sorts of actions are simply to-be-expected when the goal is money making not patient health. Absolutely predictable.

Anonymous said...

Roy, I'm sure you will comment on the following; it is pertinent to the "health care worldwide has become deeply corrupt":

Sorry to those who may not be able to read the times online.

Anonymous said...

There was discussion yesterday about this article, and the effective use of astro-turf 'patient advocacy' groups. An individual from the UK ended her discussion with this:"Don't forget that this is an article in the Guardian!!!" (as if that somehow impugns the credibility????)

I responded to her disparaging remarks with this:
The Guardian article has been picked up/reported by several healthcare blogs—whose reporting integrity I DO respect and whose analysis provides perspective. It seems that many of us already know that advocacy groups have morphed into a model of self-sustainability. Putting themselves “out of business” by finding the cure they claim to be seeking is not in their best interests. They hide behind the veil of ‘partnering’ with the profit-seekers of pharma, and claim that their ‘voice for the patient’ can only be sustained by financial support from their base. It would be interesting to discover how many ‘patients’ are allowed into the inner sanctums to voice issues with the Executive Directors of these organizations versus visits by drug and device makers, politicians, fund-raising specialists, academia KOLs, etc.


Matthew Jayden said...

This is indeed an abuse of the trust placed in patient advocacy groups by patients. This defeats the very purpose of their existence. But, then money makes the world go 'round, I suppose...

Steve Lucas said...

This issue is playing out today in the UK as the JCVI has rejected a meningitis B vaccine:

“About 1,870 people contract meningitis B each year and one in 10 dies.
The Joint Committee on Vaccination and Immunisation (JCVI) said the vaccine was not cost-effective at any price and should not yet be adopted by the NHS.
Meningitis charities have been campaigning for it to be introduced.”

Some time ago I argued against the mandate for the HPV vaccine. This was met with less than proper comments by a number of people and even many doctors ignoring the facts that the original sample did not include children in the age group of the proposed mandate and what I considered a small sample size. There were no long term studies to determine genetic issues with the vaccine with the result that a number of children have been injured and in some countries the vaccine has been put on hold due to the large number of adverse reactions.

This against the backdrop of:

“All women are at risk for cervical cancer, but it is rare in women younger than 30 years of age. The median age at diagnosis (the age at which half of all reported cases were older and half were younger) is 47 years. In 2007 (the most recent year for which statistics are available), 12,280 women in the United States were told they had cervical cancer, and 4,021 died from the disease.”

Now we face the lament of the drug companies that sales are not meeting expectations due to only a 25 – 30% vaccination rate. Additionally this failure to meet sales goals is due to politicians claiming the drug is not safe.

I in no way wish to diminish the suffering and loss of families dealing with these or other medical issues.

What I do feel is fair is to look, as done in the UK, at the financial issues of vaccinating an entire population for what may be a small benefit. I am also not swayed by the argument that I have an obligation to make those who develop a vaccine feel good by mandating their product.

Patient groups push and push for their disease, and no body can deny the suffering of those who are affected, but can we separate the need from the desire, and who is driving the conversation?

Steve Lucas