Should pharma give money to patient groups?

12 minute read

Should pharmaceutical companies be allowed to provide resourcing for patient-advocacy groups?


Say the phrase “conflict of interest” and the first thing that comes to mind is often the few paragraphs at the end of a journal publication, detailing the authors’ financial ties to industry.

But potential for bias is found in surprising places.

During 2014 and 2015, hepatitis patient groups called on the government to PBS list revolutionary new hepatitis C drugs that had cure rates approaching 100% and minimal side effects.

Their hefty price tag of around $80,000 per person per 12-week course led to an initial rejection by the PBS advisory committee, followed by protracted negotiations between the government and the manufacturers of the direct-acting antivirals.

While this negotiation was under way, the country’s peak body for hepatitis patients, Hepatitis Australia, was a vocal advocate for the PBS listing.

The group provided both personal stories and statistics of individuals harmed by the delay in access to the lifesaving medicines to the media, demanding immediate subsidies.

Meanwhile, the charity received $266,000 in 2015 from AbbVie, a major pharmaceutical company behind the new hepatitis C medicines.

This included $140,000 for the development and promotion of a book of personal stories and hopes for the future of individuals affected by hepatitis C.

According to public disclosures by AbbVie, this money was earmarked for logistics including the coordination of the personal stories included in the book, as well as a “targeted media relations program to announce the book release” and to “maximise interest among hepatitis C community members, politicians, media, and the general public”.

In the book’s foreword, Hepatitis Australia CEO Helen Tyrrell said the stories in the book would remind the community why investing in hepatitis C medications was necessary.

“These new hepatitis C medicines are gamechangers; they are a modern-day medical miracle offering a cure to the vast majority of people with chronic hepatitis C following just a few months of treatment,” she wrote. “As a nation it is imperative that we make the most of this extraordinary opportunity and invest in turning hepatitis C into a rare disease.”

The book’s launch came nine days before the publication of the findings of the government’s inquiry into hepatitis C in Australia, of which Hepatitis Australia was a contributor.

AbbVie gave an additional $50,000 to the organisation for the “Love Your Liver” awareness and advocacy project for World Hepatitis Day, two days after the government report was released.

This included money for the Take Action on Viral Hepatitis Now campaign, “with a call to action to support viral hepatitis testing, management, and treatment for affected populations and policy arms of the government and policy makers”.

During 2015, Hepatitis Australia received another $75,000 from Bristol-Myers Squibb and $60,000 from Gilead, both manufacturers of these direct-acting antivirals.

Since their listing in late 2015, the cost of the new hepatitis C medications to the PBS has topped $1 billion.

What is a conflict of interest?

A conflict of interest can be thought of as a situation where the primary obligations of a person or group may conflict, or be undermined, by a relationship with a third party.

There has been growing interest in the potential conflicts of interest of patient and consumer groups, which have a primary responsibility to represent the interests of their members.

Patient-advocacy groups are a powerful voice in healthcare, fighting for the rights and recognition of vulnerable populations, and are taken seriously by regulators and policymakers who see them as independent of profit motives.

Of course, public funding is often limited to these groups and it is common for patient-advocacy groups to received funding from industry, such as pharmaceutical or device manufacturers.

For example, in 2015 Osteoporosis Australia received $430,000 from Amgen and $75,500 from Pfizer; Arthritis Australia received $48,000 from Roche, $20,000 from Pfizer and $27,000 from Eli Lilly; Diabetes Australia received $30,000 from Bayer, $15,500 from Novartis, and Diabetes NSW alone received $100,000 from Sanofi.

“If you look at patterns of funding by pharmaceutical companies, they certainly tend to fund patient groups that are related to their product mix,” Dr Barbara Mintzes, research scientist specialising in pharmaceutical policy at the University of Sydney, said.

“For instance, a company that produces arthritis drugs will fund arthritis associations, or cancer groups will tend to be funded by companies that have cancer products to sell.”

Financial ties had the potential to bias the overall discussion, by having fewer entirely independent patient voices that could be raising concerns about the safety of drugs or price increases, she said.

“When you have a product being considered for reimbursement by the PBS, is that patient group really able to provide an independent opinion on whether the drug should be funded if they are also being sponsored by the manufacturer?” Dr Mintzes asked.

Patient-advocacy groups are a powerful voice which are taken seriously by regulators
Patient-advocacy groups are a powerful voice which are taken seriously by regulators

New research

New US research released last week indicates the potential impact the relationship might have on a patient group’s advocacy.

Researchers analysed the results of 158 organisations’ submissions on draft CDC guidelines aimed at combatting the dramatic rise in opioid use for chronic, non-cancer pain.

While four out of five groups supported the guidelines, opposition was significantly more likely in those receiving funding from opioid manufacturers (38% vs 6%).

Groups were not required to disclose their industry ties in the submissions.

Another study, published in JAMA Internal Medicine, highlighted how widespread industry funding of patient advocacy groups was.

Of a nationally representative sample of patient-advocacy groups, researchers found that two in three received funding from pharmaceutical groups.

Of these, one in 10 reported receiving more than half its funding from industry. It was a median of $US50,000, but a tenth received more than $US1 million annually – almost half of which was from pharmaceutical and device manufacturers.

What’s more, a small portion of these explicitly reported feeling pressure to conform to the interests of corporate funders.

For public-health expert Emeritus Professor Stephen Leeder, pharmaceutical company sponsorship poses an inherent and serious risk.

“Because inevitably the handouts from pharma influence the decision-making of the consumers every bit – or more – than the blandishments of pharma reps have been shown to do with doctors, and which are now illegal,” he said.

“This is why there are laws about gifts to politicians and lawmakers, and exactly the same applies here.”


Members of patient-advocacy groups undoubtedly have the best intentions, but does that protect them from being caught up in subconscious bias?

Some insight into the mindset behind these alliances may be found in an article in the trade magazine Pharmaceutical Executive, which, as the name suggests, is aimed at pharmaceutical and biopharmaceutical executives.

“Product managers see advocacy groups as allies to help advance brand objectives, like increasing disease awareness, building demand for new treatments and helping facilitate FDA clearance of their drug,” author Michael Durand wrote in 2006.

“Years before a new drug is launched, pharma companies and advocacy teams should map out how strong ties can advance corporate goals and brand objectives.”

An accompanying checklist of appealing characteristics of a consumer-group ally includes questions such as:

“What is the ‘price of entry’? does the group charge an exorbitant fee just to sit at the table? Is that fee reasonable, based on your anticipated return?”

“Would your company have a degree of control over how a program is implemented and managed?”

“Will the organisation make spokespeople, such as officers and key opinion leaders, available for media interviews?”

Direct-to-consumer advertising of pharmaceuticals is banned in most countries in the world. But industries with similar legal or social restrictions on advertising have had success promoting their messages through seemingly independent groups and individuals.

From the 1960s, tobacco companies would use smokers’ rights groups as a proxy to discredit claims that smoking had deleterious health effects.

More recently, soft-drink giant Coca Cola was exposed trying to sway the public opinion by creating the legitimate sounding “Global Energy Balance Network” group to push the message that obesity and related diseases were the fault of inactivity rather than consumption of its products.

Going one step further, the Sprout Pharmaceuticals-funded “Even the Score” campaign secured regulatory approval for its contentious female sexual dysfunction drug, flibanserin.

“There you had an outrageous public relations campaign, in the sense that the company was involved in sponsoring a campaign to promote the idea that the FDA was being sexist in not approving this drug,” said Dr Mintzes.

“Many legitimate organisations signed on to the idea that women needed access – that it was unfair that the FDA was not approving drugs for women’s sexuality – without necessarily being aware of the company’s role in that campaign,” Dr Mintzes said.

The pressure on the FDA from congressional representatives and women’s organisations had nothing to do with the actual analysis of whether the drug worked and whether it was safe.

“Often the pressure seems to be for faster access to the drugs, and there is an idea that any new drug is worth accessing,” Dr Mintzes said.

In cancer drugs, especially, it was not clear that all new, high-priced drugs were actually providing an advantage to patients, she said.

Situations like this were complicated, because it was understandable that patients would be grasping at straws when they had a disease that was not responding to treatment, she said.

“But that is the time, when you see someone close to you dealing with that situation, it is really important to separate out that vulnerability from for-profit companies that also have an interest in expanding sales,” she said.

On the other hand

Hepatitis Australia and AbbVie were unable to comment at the time of publication, but other pharmaceutical companies and patient groups pointed to the Medicines Australia guide, developed in collaboration with the Consumers Health Forum.

This stresses the importance of independence, transparency and openness.

Bayer, Pfizer, Bristol-Myers Squibb, Sanofi, Amgen, Roche were in agreement that collaborations focused on patient outcomes and not commercial ones.

Funding, educational grants, patient-education programs, sponsorship and fund-raising activities helped to support patients and advocate for their needs.

Diabetes Australia, Osteoporosis Australia and Arthritis Australia also defended ties to industry, stressing their independence.

Head of Diabetes Australia, Associate Professor Greg Johnson, said industry funding accounted for only a few per cent of Diabetes Australia’s total funding and gave companies no influence over the organisation’s policies or positions or guidelines.

Pharmaceutical and device companies were part of the business world, “and in this sense no different to any other business that has a product or service to sell”, he said.

The CEO of Arthritis Australia, Ms Ainslie Cahill, said funding received from pharmaceutical or device companies was for specific projects which advanced the organisation’s aims of achieving the best health outcomes for people with arthritis.

Arthritis Australia, which received 12% of its funding from industry last year, did not accept any funding from pharmaceutical or device companies which compromised its integrity or independence in any way, she said.

The fix?

For some, removing pharmaceutical funding altogether is what is needed to ensure patient groups are viewed as credible and independent.

If that proves too radical, improving transparency by listing specific figures of money given and the proportion of the budget accounted for by industry would help.

At the very least, firewalls, that distanced the funder from the group, were needed, Dr Wendy Lipworth, senior research fellow at the Centre for Values, Ethics & Law in Medicine at the University of Sydney, said.

“I don’t think the issue is the integrity of the consumers themselves, it’s more that they are a potentially vulnerable and exploitable group who are also incredible useful to industry,” Dr Lipworth said.

“You only have to open a newspaper to find a really sad story about someone who has been denied access to a medicine,” she said. “Those stories have a lot of power, so the consumer voice is potentially a very useful one.”

That combination of vulnerability and utility was what made it such a potentially worrying situation, she said.

“It is always very difficult to demonstrate tangible harms linked directly to a conflict of interest. The question is more how cautious you want to be given the risks,” she said.

Transparency alone was not a silver bullet, she said. “Transparency is important, but there are a number of problems with transparency as a sole means of managing conflicts of interest.”

One example was that when people disclosed conflicts of interest it could sometimes lead them to think that was the extent of their responsibility, she said.

“Once it is disclosed, then whatever behaviour might follow from that is OK, because people know about it and people can make up their own minds.”

It also put the onus onto the people receiving that information to be able to interpret it, but it was complicated to know what to make out of the knowledge that somebody had received money, Dr Lipworth said.

Even medical professionals had vastly different understandings of what a conflict of interest was, where it came from, whether it was a good or bad thing and how it should be managed, she said.

“The reality is that human beings are affected by gifts, whether that is in the form of funding, or a pen to a doctor. There is an unconscious sense of a need to reciprocate, or at least not bite the hand that feeds you, and no amount of good intention can really stop that from happening.”

JAMA Intern Med 2017; online 17 January

JAMA Intern Med 2017; online 17 January

Gilead declined to comment on whether such relationships with patient groups represented a conflict of interest

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