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Patient groups special: Swallowing the best advice?

27 October 2006
Exclusive from New Scientist
Jessica Marshall
Peter Aldhous

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.


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Who gets what

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.


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, 27 October 2006, page 18-22