[Ip-health] Big pharma mobilising patients in battle over drugs trials data

Riaz K Tayob riaz.tayob at gmail.com
Sun Jul 21 12:27:32 PDT 2013

Big pharma mobilising patients in battle over drugs trials data

Leaked memo from industry bodies reveals strategy to combat calls by 
regulators to force companies to publish results

Ian Sample, science correspondent
The Guardian, Sunday 21 July 2013 19.44 BST
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Assorted pharmaceuticals
Pharmaceutical industry has broadly resisted moves to share data from 
drugs trials more freely. Photograph: Loic Venance/AFP/Getty Images

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

Drugs companies publish only a fraction of their results and keep much 
of the information to themselves, but regulators want to ban the 
practice. If companies published all of their clinical trials data, 
independent scientists could reanalyse their results and check 
companies' claims about the safety and efficacy of drugs.

Under proposals being thrashed out in Europe, drugs companies would be 
compelled to release all of their data, including results that show 
drugs do not work or cause dangerous side-effects.

While some companies have agreed to share data more freely, the industry 
has broadly resisted the moves. The latest strategy shows how patient 
groups – many of which receive some or all of their funding from drugs 
companies – have been brought into the battle.

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.

"Some who oppose full disclosure of data fear that publishing the 
information could reveal trade secrets, put patient privacy at risk, and 
be distorted by scientists' own conflicts of interest. While many of the 
concerns are valid, critics say they can be addressed, and that openness 
is far more important for patient safety."

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.

A recent review of medical research estimated that only half of all 
clinical trials were published in full, and that positive results were 
twice as likely to be published than negative ones.

A source in the European parliament, who is close to the negotiations 
over the clinical trials directive, said he had experienced intense 
lobbying from patient groups. "We've witnessed this sort of activity in 
recent months, and it's a concern if the pharmaceutical industry is 
behind some of it. They are trying to weaken some of the transparency 
proposals and that's clear from the amount of lobbying we've had," he said.

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.

"These aren't completely unfounded concerns, but the risk already 
exists, and those things already happen. The answer is to have a 
responsible scientific community that can counteract the allegations and 
claims," the source said.

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. "That is deemed to be happening in 
any case," the memo concedes.

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 

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 

Individuals who received the memo at several other companies, including 
AstraZeneca and Novartis, did not respond.

Tracey Brown, director of the campaign group, Sense about Science, and 
co-founder of AllTrials, a campaign to get all clinical trials 
registered and all results reported, said: "We now have the prospect of 
really significant developments to end the secrecy and make clinical 
trial reporting a practical reality and, finally, some sound commitments 
from parts of industry.

"In this context, the industry associations' strategy to get others to 
raise further spurious problems is backward. It should embarrass anyone 
associated with it. I would say to the individual companies that they 
should publicly distance themselves from any association with EFPIA and 
PhRMA's strategy now," she said.

The EFPIA told the Guardian it had been working with PhRMA on a 
"commitment to enhance sharing of clinical data" to researchers and the 
public, and intended to make an announcement this week.

"Knowing that some people want all data to be made available to 
everyone, EFPIA is engaging with stakeholders to share concerns with 
harmful 're-use' of data. We will engage not only with patient groups, 
but also with the scientific community," it said.

Matt Bennett, senior vice-president of PhRMA, said in a statement: 
"EMA's proposed policies on clinical trial information raise numerous 
concerns for patients. We believe it is important to engage with all 
stakeholders in the clinical trial ecosystem, including the patients who 
volunteer to participate in clinical trials, about the issue.

"If enacted, the proposals could risk patient privacy, lead to fewer 
clinical trials, and result in fewer new medicines to meet patient needs 
and improve health."

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