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Under the microscope: Irish pharma’s engagement with doctors

It has been five years since the Irish Pharmaceutical Healthcare Association launched its transfer of value register, which publishes payments to healthcare professionals and organisations by pharmaceutical companies. Catherine Reilly reports on its impact to date and how doctors view the influence of industry

In 2020, pharmaceutical companies provided direct and indirect financial support of €1.35 million to Irish healthcare professionals (HCPs) who disclosed their names on the transfer of value (ToV) register operated by the Irish Pharmaceutical Healthcare Association (IPHA). A further €746,322 was provided to HCPs who declined to be named, according to figures supplied to the Medical Independent (MI) by IPHA.

The ToVs to HCPs — mostly doctors — included fees for consultancy/services and related expenses, as well as registration fees for conferences and associated travel/accommodation. The total payments were vastly reduced on previous years, when HCPs received approximately €6 million. IPHA would not speculate on the reasons for the decline, although the pandemic appears to have been one likely factor.

Healthcare organisations (HCOs) received €7.76 million from pharmaceutical companies in 2020. These organisations included public and private hospitals, clinical societies, postgraduate medical bodies and medical schools (see panel). The payments took the form of donations, grants and event sponsorships, as well as expenses.

According to IPHA, companies invested over €27.5 million in research and development (R&D) last year, “a vital component of the medicines’ life cycle.” This was a 33 per cent increase compared with 2019. On the ToV site, companies’ R&D investment is presented as a total figure, without any further information.

Last year, the total ToV figure was just over €37.4 million, a rise of 6 per cent on 2019.

Transparency

The ToV register was established by IPHA in 2016 on foot of a position adopted by the European Federation of Pharmaceutical Industries and Associations. IPHA described the register as heralding a “new level of transparency” in the relationship between pharma and healthcare professionals and organisations.

But the level of transparency is open to serious scrutiny. Aside from when the register was launched in 2016, IPHA has not issued an annual press release on the updated data, although some media have continued to report on the figures. The site includes broad categories to describe the nature of the payment on each company page (ie, fee for service and consultancy; donation/grants to HCOs/contribution towards cost of events) but it lacks information on the service provided, or the names of the conferences concerned.

HCOs are named in an inconsistent matter — often only the institution name is included, rather than the department to which the payment related. Organisations cannot block disclosure of ToVs, but a different situation applies to HCPs under data protection law.

For organisations, “contract law is applicable and companies can require that provision of payments is dependent on the HCO being named publicly on transferofvalue.ie”, stated IPHA’s spokesperson. “We have 100 per cent disclosure of HCO transfers of value as a result. For HCPs, GDPR applies and contract law cannot be used for the disclosure piece.”

The HCP consent rate in 2020 was 68 per cent — 4 per cent higher than in 2019. The rate for 2015 was 55 per cent. “Our companies request that HCPs disclose on transferofvalue.ie,” according to the Association. IPHA has been investigating use of ‘legitimate interests’ as the legal basis for processing personal data — an approach it says has increased disclosure rates to nearly 100 per cent in some European countries.

The Association has “received considerable legal advice” on this area and has provided training and information to companies. The Association has not specifically advised companies to use ‘legitimate interests’ as the basis for disclosure, but it has informed companies that legal opinion has stated it is suitable.

As this matter related to GDPR, companies “should make their own decisions about what legal basis to use”.

Unsearchable

Interested parties — including patients — may wish to check whether a doctor or HCP is listed on the ToV site. However, it has no search engine and comprises 45 separate company pages with hundreds of entries.

Asked if it planned to introduce a search engine, IPHA’s spokesperson commented: “Regulatory guidance on legitimate interests requires that data controllers document the specific legitimate interests they are relying on, the countervailing rights and interests of the data subjects (here, the HCPs) and how they have balanced those rights and provided for safeguards for the data subjects.

“Other data protection agencies in Europe dealing with this type of data have required certain safeguards to be built into the data processing. One of the data protection agencies required that protocols be applied to the website which hosted the publication of the data (‘the host website’), preventing the indexing of the data through search engines.

“It required that the host website clearly state the purpose of the publication of the transfer of value data and that the publication did not provide a general permission to those accessing the website to undertake additional processing of the HCP data, such as cross-checking the data with other information published on other companies’ websites.”

There seems to be a concern that the relationship between physicians and the pharma industry

is inherently problematic. I do not accept this

Deficiencies

Industry-driven disclosure initiatives may be seen as an attempt to obscure the path towards statutory registers.

Some studies have shown a range of deficiencies associated with self-regulated industry databases, noted a recent academic analysis of IPHA’s ToV register, published in Health Policy. The paper by RCSI researchers, titled ‘Payments reported by the pharmaceutical industry in Ireland from 2015 to 2019: An observational study’, found “various data errors, and significant variation between companies in their methodology notes and disclosures” on the IPHA ToV site, “with inconsistent approaches to identifying individuals, and aggregation and exclusion of payment”.

The study found examples of exclusions that it said breached the IPHA code of practice, such as a company excluding payments under €100.

“By systematically identifying methodological problems, arbitrary exclusions and breaches of the IPHA code of practice, this study demonstrates a fundamental flaw with self-regulation likely to be repeated in other jurisdictions operating with similar systems.”

Payments totalling €163 million were reported by 47 companies during the study period of 2015–2019, including €84.6 million for R&D, and non-R&D payments of €45.1 million to HCOs and €33.6 million to HCPs. As the paper described, the core issue was that such payments can create a conflict of interest (COI).

According to the authors from RCSI’s School of Pharmacy and Biomolecular Sciences and Department of General Practice: “Evidence from a Cochrane review suggests that industry-sponsored research is more likely to produce findings favourable to the sponsor’s product.

“Other evidence shows that receipt of payments from the pharmaceutical industry is associated with higher prescribing rates, higher prescribing costs, increased use of specific drug classes, including opioids, and lower prescribing quality.

“Clinical guideline development can also be affected by industry payments, with many authors having interaction with pharmaceutical industry, including manufacturers of treatments recommended in guidelines.”

A legislated system of mandatory disclosure could address deficiencies associated with industry initiatives, posited the authors. However, while such a system could increase transparency and allow “accurate quantification of payments”, this was only “a first step in addressing the negative influence of pharmaceutical industry payments on prescribing and healthcare delivery”, they stated.

IPHA’s spokesperson told MI: “There are standard requirements for reporting and our members meet those requirements, so variation between companies is minimal.” The spokesperson said that “in relation to alleged data exclusions, we rely on the information we receive from companies which, as far as we can ascertain, is accurate. We won’t be commenting on any individual company’s record.”

More broadly, all alleged breaches of the IPHA code of practice “are thoroughly investigated through a process led by the Code Council. The findings of any investigations are published and we submit these findings to the Department of Health.”

IPHA’s spokesperson stressed that the ToV register was a “transparency initiative” brought about by industry itself.

Doctors’ views

In Ireland, continuing professional development (CPD) is mandatory for registered doctors. Many clinicians say that limited State funding for ongoing medical education has meant that doctors, training bodies and clinical societies rely heavily on industry to fund and provide access to conferences, talks, workshops and courses, as well as fund various research and training initiatives and direct patient care not covered by healthcare budgets.

Many doctors considered that engagement with pharma, such as participation in advisory boards, is an important element of driving new therapies and treatment approaches.

In 2020, payments to named HCPs ranged from double-digits to thousands. MI contacted some of the hundreds of doctors listed on the ToV site to seek feedback on the nature of these payments. The referenced payments are a small sample from the register and the quoted doctors actively responded to MI’s request for comment.

Prof Sean Gaine, Consultant in Respiratory Medicine at the Mater Misericordiae University Hospital in Dublin, is listed on the Janssen page as receiving €29,854, mainly in fees for consultancy/services (€28,160)

Prof Gaine speaks at many educational meetings, some of which are sponsored by industry. He noted that during the pandemic, virtual educational meetings became easier to arrange logistically and their reach could extend without the limitations of air travel and time zones.

“While I am involved in advisory boards and drug safety monitoring for Janssen, the main work would still be educational meetings,” he outlined. “Rather than big multi-speaker symposiums like we were familiar with pre-Covid, there has been a lot of interest in using the virtual approach to develop disease awareness at grand rounds and smaller group sessions throughout the world.

“As a pulmonary hypertension specialist, I am always honoured to be invited to discuss cases and new guidelines with emerging centres. I was also asked to share our experiences managing Covid in Ireland in several educational meetings.”

Prof Gaine has previously outlined his views to MI on the ToV register. He said provision of context to the payments would be preferable. He also said transparency was an important element of mitigating the well-established risk of bias arising from engagement with pharma.

Consultant Psychiatrist Prof Jim Lucey is listed on the Lundbeck page as receiving €1,500 in fees for consultancy/services. “My views on the relationship between pharma/industry and medicine are consistent with the views of the Irish College of Psychiatrists, of which I am a member and whose policy I support,” stated Prof Lucey.

Several years ago, the College of Psychiatrists ceased pharma sponsorship of its conferences and the awarding of external CPD points to meetings organised or sponsored by pharma.

On the listed fee, Prof Lucey said he teaches on mental health in a variety of settings, both sponsored and unsponsored.

“My theme is general wellness/mental health and the content is not pharma-related. There is a need to speak up for the mental health of clinicians. There are many stressed and distressed doctors and nurses working in the health services during these exceptionally difficult times.

“The talk to which you refer was the first I gave during the Covid-19 crisis and was specifically prepared for an audience of Irish GPs. As per policy, there was no mention of pharmacy or industry products. My topic/title was ‘Maintaining doctors’ mental health during this national crisis’. The talk was well received.”

Prof Lucey said he always encourages trainees to advocate, whenever possible, for mental health and wellness within the profession. He also urges them to “stay within the evidence-based guidelines”.

Some doctors listed on the ToV site are HSE National Clinical Leads. The HSE does not have a specific policy position on clinical leads’ engagement with pharma.

Prof David Kane, HSE National Clinical Lead for Rheumatology, is listed on the Janssen page as receiving €2,587, mostly in fees for consultancy/services (€2,100). Prof Kane informed MI: “The fee received was for giving an online lecture to other doctors on how to diagnose psoriatic arthritis, with an emphasis on developments in ultrasound imaging, which is an area of specific expertise of mine.

“The fee covered preparation time and time delivering the talk. It didn’t deal with the prescription of their products. Janssen run educational programmes on the diseases they treat, one assumes to develop a more positive profile with healthcare professionals and in my experience, they take great care to avoid bias by looking for independent experts and are very keen to highlight IPHA guidance at all stages.”

Prof Orla Hardiman, HSE National Clinical Lead for Neurology, was listed on the Biogen page as receiving €3,250 in fees for consultancy/services.

“The payment from Biogen was in the context of a symposium for the World Muscle Society — I gave a presentation on a clinical trial on which I had also written an editorial for the New England Journal of Medicine. One of the requirements was that I did not have any conflicts of interest in this presentation, which I didn’t (the gene therapy was for a variant of MND that we do not see in Ireland). Biogen provided me with an honorarium, as there was quite a lot of work in developing the slide-deck.”

The neurologist would favour a mandatory register. She agreed with colleagues who have maintained “that we need to make it very clear that advisory panels are necessary to allow us to inform industry”. She said participating in an ad board may require significant work and that it is reasonable to compensate professionals for their participation.

More generally, Prof Hardiman also expressed concern “that if we start putting in too many barriers to engagement between pharma representatives and clinical professionals, we risk losing access to important data about new treatments”.

She outlined: “Engaging in dialogue with industry representatives in this respect is both useful and acceptable in my opinion, and this often takes place in the form of robust discussion with representatives who present data. I think that if we prohibited this, we would risk losing an opportunity to critically assess drugs that are new to the market.”

“Certainly, in my own experience, the opportunity to critically review data with pharma representatives is very useful, as I can also ask questions, challenge the data, and on occasion, seek additional clarifications. I have often sought additional information from the Medical Director of the company.

“This type of dialogue enhances our knowledge and is good for our ability to safely prescribe new compounds (or in some instances, to explain to patients why we think that we should not prescribe a particular compound).”

Prof Hardiman, who is recognised internationally for her clinical research into amyotrophic lateral sclerosis/motor neurone disease, added: “There seems to be a concern that the relationship between physicians and the pharma industry is inherently problematic.”

“I do not accept this. As a physician who also engages in clinical trials, I am conscious that for better drug development (all my patients have untreatable diseases), we need to be able to engage with the industry.

“As ethical practitioners, of course we must continuously ensure that our engagement is founded on a desire to enhance patient care, and that we and the industry comply with the appropriate codes of practice to safeguard our respective integrity.”

Mandatory registers

Prof Adriane Fugh-Berman is a Professor in the Department of Pharmacology and Physiology and Department of Family Medicine at Georgetown University Medical Centre (GUMC), US.

She is the Director of PharmedOut, a GUMC project that “promotes evidence-based prescribing, educates healthcare professionals about pharmaceutical and medical device marketing practices, and provides access to unbiased information about therapeutics”.

MI shared with Prof Fugh-Berman a previously published article on pharma payments to Irish doctors and healthcare (‘Shifting doctor/pharma boundaries’, Medical Independent, 21 February 2018). Prof Fugh-Berman said she read the article with interest because she considered that many of the quoted doctors had “their heads in the sand”. Some of the arguments of the doctors included that the content of their pharma-sponsored talks was independent.

According to Prof Fugh-Berman, doctors in these types of situations are never paid to promote specific drugs, but to promote specific diseases. “Perhaps if physicians saw that their supposedly objective talks are actually linked to specific drug promotion, the scales would fall from their eyes.”

She said marketing a drug starts seven-to-10 years before it comes up for approval. “During that time, the company is not pushing a specific drug; it is shaping perceptions of specific diseases in order to prepare the market for specific drugs.”

Prof Fugh-Berman acknowledged a differentiation between receiving support for bona fide research versus payment for speeches, advisory board participation, consulting, etc. However, she maintained “even research funding biases researchers towards the products they study. We all feel attached to what we study”.

She also advised that a disclosure register should be mandatory, otherwise the sample would be “very skewed”. “The people who have less to disclose are much more likely to be transparent about their payments. And even if some people who are getting paid a lot disclose, I am sure they feel they are making themselves targets, as one of the people in your [2018] article confirms.”

In the US, the Physician Payments Sunshine Act came into effect in 2014. It legally requires the reporting of ToVs to doctors from pharmaceutical and medical device companies. The payments have decreased over the years, but the reasons for this are multifactorial and gifts/payments are still very common, according to Prof Fugh-Berman.

While researchers have utilised these data to publish many studies on COIs and prescribing behaviour, “there is no evidence that physician behaviour regarding COI has changed, or that employers, meeting organisers, or medical journals are excluding physicians based on conflicts of interest,” stated a recent paper co-authored by Prof Fugh-Berman in the Journal of General Internal Medicine (‘A Ray of Sunshine: Transparency in Physician-Industry Relationships Is Not Enough’, 2021).

The paper maintained that disclosure was necessary, but “not sufficient to address the damage that industry relationships causes to medical knowledge and public health”.

It argued the need for “a serious effort to eliminate financial COI”. It said measures in medical schools and training programmes to decrease interactions between students and trainees and pharmaceutical companies have made physicians less susceptible to industry influence when they are in independent practice.

The paper proposed that, among other measures, professional conferences and meetings should include a majority of speakers without COIs and should consider disallowing any speaker with a COI. Continuing medical education should be delivered without any commercial involvement.

Prof Fugh-Berman told MI: “The way that you can tell that drug reps are influencing your practice is that they keep coming back… The way that you can tell that a company is making money off of your involvement with them, is that they keep paying you.”

Pharma’s financial support for healthcare

The pharmaceutical industry provides significant financial support to Irish healthcare, including the funding of some posts and trainee bursaries, although this level of detail is not included on the Irish Pharmaceutical Healthcare Association’s transfer of value (ToV) site. MI contacted a range of healthcare organisations to seek further detail on a sample of listed payments from 2020.

This newspaper asked South/South West Hospital Group (SSWHG) about the following ToVs: €62,623 from Eli Lily to Cork University Hospital (CUH); €37,274 from Eli Lilly to Mercy University Hospital; €32,220 from Pfizer to CUH; and €26,768 from Novartis to University Hospital Waterford.

A SSWHG spokesperson referred MI to the ToV site and provided no additional details on these payments. Saolta University Health Care Group advised that a payment of €13,370 from Novartis to Portiuncula University Hospital was towards the costs of purchasing a new cardiac echo machine. A listed payment of €15,000 from Novartis to Sligo University Hospital was used to “support ICT software for chronic disease management in cardiology services”. Children’s Health Ireland stated €68,000 was received from three pharma companies in 2020. The funding did not support “mainstream operation posts”.

MI awaited responses from other Hospital Groups at press time.

Meanwhile, the ICGP was queried about funding of €136,500 from Amgen (listed as a contribution towards cost of events) and €46,000 from Pfizer (€45,000 was a donation/grant; the remainder a contribution towards cost of events).

Dr Claire Collins (PhD), Director of Research and Innovation, ICGP, said the cited grants were fully compliant with its sponsorship policy, which is on its website. The Amgen grant covered “both education and research”; the Pfizer grant covered a research-only component.

The RCPI was queried about funding of €160,000 received from AbbVie (€150,000 was listed as a donation/grant and the remainder as a contribution towards cost of events).

A response was awaited. NUI Galway was asked about funding of €16,100 to the “Department of Medicine” from Novo Nordisk. A university spokesperson said this grant supported a research project titled ‘Metabolic risks in women with gestational diabetes diagnosed using the IADPSG [International Association of the Diabetes and Pregnancy Study Groups] criteria compared to women with normal glucose tolerance — a 10-year follow-up’.

The spokesperson said NUI Galway has an “extensive policy” on COI.

UCD School of Medicine was asked about a payment of €4,500 listed on the Lundbeck page in the section for contribution to cost of events. A response was awaited.

Major patient organisations supported by pharma

Irish Heart Foundation

In 2020, approximately €330,000 (6 per cent) of the Irish Heart Foundation’s income was received from pharmaceutical companies, namely Pfizer, Novartis, Bayer, Vifor Pharma UK, Daiichi Sankyo, Boehringer Ingelheim and AstraZeneca.

“In line with the IPHA code of practice, the Irish Heart Foundation retains full control of all information which is published thanks to funding from the pharmaceutical sector and there is a strict understanding that the Irish Heart Foundation will not endorse products by the pharmaceutical companies. All this information is reviewed and overseen by healthcare professionals, including our Medical Director and members of our Medical Advisory Councils,” outlined a spokesperson for the Foundation.

“The majority of funding we received in 2020 from pharmaceutical companies was requested by the Irish Heart Foundation for specific programmes, including the introduction of our nurse support line, and as requested by the National Stroke Programme, our new stroke check-in service that provides vital support when moving from hospital to home following a stroke.”

The Irish Heart Foundation’s total income in 2020 was €5.68 million. Of this, €773,000 (14 per cent) was received through Government grants. This represented an increase on previous years due to Covid-19 specific grants. For example, in 2019, just 6 per cent of its funding came from the State.

Irish Cancer Society

In 2020, the Irish Cancer Society received approximately €290,000 in funding from 15 different pharmaceutical companies, according to the Society.  This included support for a range of initiatives including its lung cancer awareness campaign (Astra Zeneca and BMS), women’s health initiative (Pfizer), annual patient conference (Amgen and Janssen), as well as a mix of employee fundraising and Covid-19 support. This funding comprised 1 per cent of overall income in 2020.

“To guarantee impartiality, integrity and transparency, the Irish Cancer Society’s corporate partnerships policy sets out specific guidelines for working with the pharmaceutical industry to ensure that pharma funding does not in any way influence the contents of our literature, patient advice or strategic goals.”

The Society typically receives only 3 per cent of its income from the Government.  According to a spokesperson, it is “thanks to the generosity of our wonderful donors, fundraisers and volunteers that we are able to provide services and support to ensure nobody in Ireland has to face cancer alone. In 2020, grants from the State represented 7 per cent of total income, this was due to the Society having availed of two Covid-19-related Government schemes; the temporary wage subsidy scheme, and the restart grant scheme.”

Marie Keating Foundation

In 2020 the Marie Keating Foundation received €271,000 worth of funding from “a number of partners from the pharmaceutical sector” in the form of education grants and charitable donations. “Each grant was applied for and used for a specific cancer awareness campaign, support programmes or projects,” said a spokesperson. “Each grant applied for funded a specific campaign, project or service where the Marie Keating Foundation saw a clear patient or public need. At all times, the Marie Keating Foundation had full discretion on the campaign or programme content and execution. Once the funds were granted there were no conditions attached to the funding other then that it was used in its entirety for the purpose it was applied for.”

Across all campaigns, projects or services that are funded fully or in part by the pharma sector, the Foundation “never promotes or mentions any specific drug or therapy types and has never been asked to do so”.

In compliance with the IPHA code, “each of the educational grants or charitable donations are underpinned by grant agreements in which it is clearly specified that the grants are not conditional in any way on any pre-existing or future business relationships between the pharma company and the Foundation”, according to the spokesperson.

The charity said its funding is publicly available in its annual accounts, which are published in the annual report. The Foundation has not received any Government funding in 2021.

The Asthma Society of Ireland

This newspaper requested details on pharma support and information was awaited.

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