Leaked memo
from industry bodies reveals strategy to combat calls by regulators to force
companies to publish results
The Guardian, Ian Sample, science correspondent, Sunday 21 July 2013
 |
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 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."
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."
