Healthy Skepticism Library item: 6346

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Publication type: Journal Article

Marshall J, Aldhous P.
Patient groups special: Swallowing the best advice?
New Scientist magazine 2006 Oct 27; (2575):18-22
http://www.newscientist.com/channel/health/mg19225755.100-patient-groups-special-swallowing-the-best-advice.html

Notes:

To see table on who gets what http://www.newscientist.com/data/images/archive/2575/25755101.jpg

Full text:

THEY are supposed to be grassroots organisations representing the interests
of people with serious diseases. But Drummond Rennie, professor of medicine
at the University of California, San Francisco, and deputy editor of
the Journal of the American Medical Association, believes that some patient
groups are perilously close to becoming extensions of pharmaceutical
companies’ marketing departments. “There’s a crisis here,” he contends.

Rather than grassroots, the word Rennie uses to describe such organisations
is “astroturf”. Originating in the black arts of politics and public
relations, astroturfing is the practice of disguising an orchestrated
campaign as a spontaneous upwelling of public opinion.

Other health specialists don’t go as far, but they are still uneasy about
the financial relationships between drug firms and prominent patient groups.
“I think there are grounds to be concerned,” says Joel Lexchin, who studies
pharmaceutical policy at York University in Toronto, Canada. He and others
point to instances in which representatives of patient groups, sometimes in
close contact with corporate public relations teams, have spoken favourably
about drugs at meetings or press conferences.

It is easy to see the appeal for pharmaceutical companies. Patient groups
provide people with information about available treatments for a particular
disease and offer support to those affected by it. They campaign for
treatments to be financed by publicly funded health insurance programmes,
and some patient representatives are members of advisory committees that
consider drugs for approval. Firms would clearly have much to gain by
filtering their marketing messages through such organisations, which tend to
engender more trust than do multinational companies.

Self-policing

Patient groups rely largely on public donations for support, and must adhere
to the financial and lobbying restrictions that apply to all public
charities. However, when it comes to the type of information the groups
provide, they are largely self-policing. Many groups were founded by
patients or their family members, and they range from small, volunteer-run
organisations to large operations with executive staff.

So is the charge of astroturfing fair? How much money are patient groups
typically taking from pharmaceutical and medical device firms, and does this
affect their behaviour? To investigate, New Scientist conducted the
largest survey to date of industry donations to patient groups based in the
US – the biggest single market for drugs and medical devices. As well as
taking a random sample, we identified groups associated with conditions for
which companies have been accused of “disease-mongering” – encouraging an
expansion of the boundaries of an illness in order to boost sales of a
treatment for it (see “How the groups were selected”, below). Though these
allegations are unproven, we decided it was important to investigate whether
any patient groups have received unusually large proportions of their
funding from industry.

In each case, we tried to determine the percentage of a group’s total
funding that came from the pharmaceutical and medical device industry in the
most recent year for which figures were available. This was not always easy,
as US non-profit organisations are not required by law to disclose their
donors’ identities. Tax returns and annual reports provided some of the
information, but in most cases, obtaining a figure required the group
concerned to provide it voluntarily.

The extent of industry funding varied widely (see Chart, right). In some
cases the cash amounts were enormous – more than $23 million in the case of
the American Heart Association, the largest organisation studied, although
this accounted for just 4 per cent of its total funding. Small proportions
of funding may not be cause for concern, Lexchin says, unless they go toward
activities like creating biased treatment information. “It depends how the
money is used.” Lexchin also believes there is a need for greater
transparency about where such donations are coming from, so patients can
evaluate for themselves the information the groups are providing.

In total, seven groups received 20 per cent or more of their funding from
pharmaceutical and medical device companies, including all four linked to
the conditions over which accusations of disease-mongering have been made.

One of these groups, the Depression and Bipolar Support Alliance, said it
received more than half of its 2005 funding from industry. The group did not
provide an exact percentage, but combined information from its annual report
and tax return reveals that 77 per cent of its revenue for 2005 came from 15
major donors, 12 of which are drug or device companies.

Only one other organisation, the Colorectal Cancer Coalition, or C3,
received a greater proportion of its revenue from drug and device firms.
This group, part of our random sample, is only in its second year of
existence. Director of operations Judi Sohn says C3 is working to diversify
the organisation’s funding sources to make its finances more stable.

So are companies specifically targeting those groups which offer the
greatest potential for marketing their products? In general, groups in our
survey that received more than 20 per cent of their funding from industry
did seem to be associated with conditions that affect a significant number
of people, for which a specific therapy exists and which require long-term
treatment, therefore creating the potential for substantial profit.

The Restless Legs Syndrome (RLS) Foundation, for instance, received more
than $450,000 of its $1.4 million revenue in 2005 from GlaxoSmithKline (GSK)
and nearly $178,000 from Boehringer Ingelheim. GSK’s drug Requip was
approved for the syndrome in 2005, while Boehringer Ingelheim has a drug
pending FDA approval. Both drugs are intended to control the symptoms of RLS
over long periods. While these symptoms can seriously disturb sleep, critics
claim that their prevalence has been exaggerated by GSK and in media
reports.

The extent of industry funding of the RLS Foundation is “pretty incredible”,
says one such critic, Steve Woloshin of Dartmouth Medical School in Hanover,
New Hampshire. However, both the RLS Foundation and GSK reject accusations
of disease-mongering. GSK is clear that Requip is indicated for moderate to
severe RLS only, says company spokeswoman Holly Russell. “The main sense we
get from patients is an enormous sense of relief,” she adds. “Show me the
scientific article that says that people who don’t have the condition or
people that have very mild RLS are flocking to take drugs,” says Georgianna
Bell, executive director of the RLS Foundation.

By contrast, groups in our survey that received no industry funding seemed
to be for diseases that drug companies have little opportunity to profit by.
For example, the people supported by Faces, the National Craniofacial
Association, are typically treated with surgery, while the Ehlers-Danlos
National Foundation is for people with a disorder of the body’s connective
tissue for which there is no specific treatment. The Amyotrophic Lateral
Sclerosis Association received just 0.6 per cent of its $16 million budget
for 2005 from pharmaceutical companies. This neurodegenerative disease is
typically fatal within four years of diagnosis, and there is only one drug
approved by the US Food and Drug Administration to treat it. Aventis, which
manufactures the drug, provided $10,000 to the association.

The timing of donations also suggests a link to marketing interests, though
donations to individual groups can vary from year to year for various
reasons. Pfizer, for example, was a major donor to the RLS Foundation in
2003 and 2004. In July 2004 the firm announced that it had ceased developing
its candidate RLS drug, and the following year donations to the patient
group ceased.

Meanwhile, concerns about the safety of psychiatric drugs in children, which
reached new heights in 2004, have hit the Child and Adolescent Bipolar
Foundation hard. Its donations from industry fell from about 40 per cent of
its total revenue in 2004 to 20 per cent in 2006. “Pharmaceutical companies
are not as willing to support us because of increased scrutiny around
psychiatric treatments in children,” says Susan Resko, the foundation’s
executive director. As a consequence, she has had to lay off more than half
of her staff.

It should come as no surprise that a company would donate where its
commercial interests lie, but is this a problem? Some groups argue that the
funding allows them to expand their operations and serve more patients than
they would be able to otherwise. “Should I say no to company donations and
not benefit all the people that we serve?” asks Virginia Ladd, president of
the American Autoimmune Related Diseases Association. Ladd claims the
organisation could not raise enough money for national campaigns if it had
to rely on individual donations alone.

Every group in our survey that received a high proportion of funding from
industry denied that it biased their mission. Companies have no input into
how the money is used, they said, and some added that they had turned down
funding that they felt came with strings attached. Most of the organisations
also stressed that they do not endorse specific drugs or therapies, and that
any treatment information posted on their website is approved by a medical
advisory board. “We’re extremely conscious of our ties with any of our
funders,” says Catherine Rice, executive director of the International
Essential Tremor Foundation. “It’s got to be an arm’s length away.”

Critics claim, however, that dependence on industry funding can
unintentionally compromise an organisation’s objectivity. “I think it’s
naive to think that you aren’t being influenced,” says Douglas Ball of
Kuwait University, who has studied patient groups in many countries,
including the US. Lexchin agrees: “Psychologists talk about the ‘gift
relationship’. The patient organisations are getting something and feel the
need to repay that gift. Whether they are conscious of it or not is really
irrelevant.”

Sharon Batt of Dalhousie University in Halifax, Canada, has just begun to
study patient group behaviour and funding after years working in breast
cancer advocacy, where she noticed a general pattern. Organisations that
accept pharmaceutical funding “tend to advocate for faster review and
availability of drugs, greater insurance coverage, and they tend to see
‘direct-to-consumer’ advertising as a benefit to patients”, she claims.
Groups that maintain financial independence, on the other hand, “emphasise
safety over speed and are critical of direct-to-consumer advertising”, she
says (see “Virtuous but poor”, below).

Information on the websites of some groups in our survey raises further
questions. For example, the treatment section of the Depression and Bipolar
Support Alliance’s site was developed with an “educational grant” from
Neuronetics, a company which gave at least $10,000 and possibly as much as
$150,000 to the alliance in 2005. One page describes transcranial magnetic
stimulation (TMS) and vagus nerve stimulation (VNS) which both aim to treat
mood disorders by stimulating neural activity. Neuronetics makes equipment
for TMS, which has not yet been approved as a treatment. Nevertheless, the
site provides web links and telephone numbers for Neuronetics and
Cyberonics, a VNS equipment maker that donated between $150,000 and $500,000
to the alliance in 2005.

The AMD Alliance International, which is for people with a common cause of
sight loss called age-related macular degeneration, did not provide
information on its industry funding. A note posted on the organisation’s
website in June “loudly applauded” the US approval of Lucentis as a
“ground-breaking treatment”. International rights for marketing Lucentis are
held by Novartis Ophthalmics, the alliance’s “founding global sponsor”.

Whether or not such examples represent inappropriate corporate influence,
critics argue that such groups should be more transparent about where their
funding comes from – especially since they are a vital source of information
and people will expect them to be impartial. “Groups should publicise how
much money they’ve gotten from which companies and what it is used for,”
Lexchin says.

Ball’s team recently examined the websites of 69 national and international
patient groups, and concluded that they gave insufficient financial
information to evaluate whether a conflict of interest existed. Annual
reports, which were provided on 37 sites, were often inconsistent with
information found elsewhere, while only seven itemised donations from
pharmaceutical firms and none chose to list the total proportion of industry
funding (BMC Public Health, DOI: 10.1186/1471-2458-6-201). “Basically,
it’s a muddle, which these organisations haven’t thought about coherently,”
says co-author Andrew Herxheimer of the UK Cochrane Centre in Oxford.

Some patient groups don’t provide information on their funding as a matter
of policy. The public relations consultant for the Neuropathy Association
told New Scientist that the information was “proprietary”, and wouldn’t
discuss the group’s guidelines on receiving donations, while the director of
the National Spasmodic Dysphonia Association called the subject “a sensitive
topic for our board”, and declined to provide figures. Families for
Depression Awareness similarly declined to answer our queries.

Complete disclosure of industry funding by patient groups is almost unheard
of, but the massive American Heart Association, which boasts an annual
revenue of more than $650 million, is leading the way. This month, it will
begin posting an itemised list of pharmaceutical and medical device company
donations on its website.

Until now, most patient groups have been shielded from public scrutiny of
their finances. “There is a tendency not to want to criticise the motives of
the patient groups, because a lot of them are made up of people who are
pretty seriously sick,” says Batt, herself a breast cancer survivor. She
argues that such organisations need to put their house in order and accept
the need for greater transparency.

Only then, claim the critics, will patients be able to make informed
judgements about which groups they can really trust.
How the groups were selected

We selected 20 US patient groups operating on a national level with annual
revenues of more than $100,000, plus five with revenues exceeding $10
million, pulling them at random from the GuideStar database, which provides
information on US non-profit organisations.

In addition, we identified four further groups, again with annual revenues
exceeding $100,000, associated with bipolar disorder, restless legs syndrome
and attention deficit hyperactivity disorder. These conditions were
highlighted in April by the journal PLoS Medicine as being susceptible to
“disease-mongering” by the pharmaceutical industry.

Virtuous but poor

Just two groups identified in New Scientist‘s survey – the National
Women’s Health Network (NWHN) and Breast Cancer Action – refuse to accept
donations from pharmaceutical or medical device companies. “We want women to
know that when they come to us, they are getting independent information,”
says Amy Allina, the network’s programme director. “We think of ourselves as
virtuous, but poor.”

The NWHN was a prominent advocate of one of the clinical trials in the
Women’s Health Initiative, the largest-ever study of post-menopausal women,
which investigated the use of hormone replacement therapy (HRT). The trial
was halted in 2002 after finding that HRT increased women’s risk of heart
attack, stroke and breast cancer. “We have been very active critics of the
ways drug companies have promoted HRT,” says Allina. On its website, the
NWHN stresses that women who choose to have HRT should take the lowest dose
possible for the shortest time.

The same basic information is also posted on the website of an organisation
not included in our survey, the Society for Women’s Health Research (SWHR),
but its position on HRT seems more ambiguous. The society’s president and
chief executive officer, Phyllis Greenberger, told The Washington Post in
September 2005 that she believed the risks of the treatment had been
exaggerated, and described her own experience with HRT over more than 10
years. “I feel better, I have no side effects and in my case I see no
downside,” she told the newspaper. SWHR does accept funding from the drug
industry – including from Wyeth, a manufacturer of the hormones used in HRT.
>From issue 2575 of New Scientist magazine, 28 October 2006, page 18-22