Shifting doctor/pharma boundaries

Medicine and pharma are intrinsically linked.

At most medical conferences, the note of gratitude to ‘friends in the pharmaceutical world’ for their sponsorship, and the exhibition stands placed where delegates break for refreshments, give form to the deep connections at play.

But it goes well beyond that. Pharmaceutical companies regularly cover the registration fees, flights and accommodation of doctors and other healthcare professionals attending international conferences, and pay fees to those delivering talks and serving on drug development committees and advisory boards. Pharma-sponsored CPD-accredited meetings often take place in healthcare settings, while reps freely call to clinicians at their workplaces. The industry says the relationship helps healthcare professionals to provide best patient care and companies to develop and provide medicines. Clinicians say that limited State funding for mandatory CME/CPD medical education means that Irish 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 that healthcare budgets do not cover.

<h3 class=”subheadMIstyles”>Payments</h3>

Details compiled by the <strong><em>Medical Independent</em></strong> (<strong><em>MI</em></strong>) from 44 separate company pages of the Irish Pharmaceutical Healthcare Association (IPHA) Transfer of Value (ToV) website show participating companies (including six non-IPHA member companies) paid €3.8 million to named healthcare professionals in 2016. A further €3.3 million was paid to healthcare professionals who withheld their names. The total amount given to healthcare organisations in 2016 was just over €10 million.

A small sample of the 2016 payments to membership/training colleges included €100,000 from AbbVie to the RCPI (the RCPI said this covers two bursaries in rheumatology to two trainees, awarded €50,000 each over a two-year period. The payment comes to RCPI and is in turn awarded from the RCPI to the successful rheumatology trainees); €99,530 from Pfizer Healthcare Ireland to the ICGP (the ICGP said its sponsorship policy is publicly available on its website); and €20,800 from Bayer to the RCSI (the RCSI said its relationship with industry and third parties is primarily based on sharing intellectual property (IP), patient insight and future technology. The RCSI does accept/receive sponsorship from relevant industry sponsors to, for example, support the delivery of certain stand-alone CPD courses but such sponsorship “confers no rights or influence over course content or delivery”).

In 2016, payments to hospitals included €106,250 from Pfizer to Connolly Hospital, Blanchardstown; €30,430 from Shire to the Children’s University Hospital, Temple Street; and €183,232 from AbbVie to the Mater Misericordiae University Hospital, Dublin, as examples. Temple Street said Shire and Alexion fund a WTE Clinical Nurse Manager II/Research Nurse and it received over €51,000 for this post in 2017.

Comment on the issue was still awaited from HSE Hospital Groups by press time.

In 2016, IPHA announced a “new level of transparency” in the relationship between pharma and healthcare professionals and organisations.

Launching its ToV register, it reported that IPHA member companies paid €27.2 million to Irish healthcare organisations and healthcare professionals in 2015. “Transfers” of €6.8 million were made to healthcare professionals (mainly doctors) and €10.7 million to healthcare organisations, while the R&D value was €9.7 million.

IPHA underlined that the register made “details of transfers of value” publicly available by the industry for the first time. But this detail has its limitations. The register is not searchable by named healthcare professional or healthcare institution. Furthermore, under data protection law, healthcare professionals may refuse to have their names disclosed.

The consent level from healthcare professionals to disclose their names alongside ToV data was 57 per cent for 2016, a slight rise from 55 per cent in 2015. No context or background is provided on the nature of payments beyond broad categories, which is of concern to some doctors who spoke to <strong><em>MI</em></strong>. Last year, IPHA did not issue a press release to inform the media of the returns for 2016.

As to why IPHA did not do so, Mr Oliver O’Connor, CEO of the Association, says it was felt there was “no new news”.

“The news was when it was done for the first time and now it is happening every year, so we didn’t feel there was any compelling news-line for media arising out of it,” Mr O’Connor told <strong><em>MI</em></strong>. “But that is not to say we wouldn’t do something again at any other point.”

<h3 class=”subheadMIstyles”>‘League tables’</h3>

The IPHA register is part of a voluntary Europe-wide initiative of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

However, some jurisdictions have instigated statutory disclosure regulations, such as the Physician Payments Sunshine Act in the US, while .

While some critics claim that voluntary registers may well be pharma’s way of controlling the narrative and staving-off the inevitable statutory initiatives, Mr O’Connor says this is not so. He says the ToV register is a “significant step forward from what was there before — which was nothing”. The IPHA says it aims for full disclosure but not “league tables”. There are no plans to introduce user-friendly search mechanisms.

“The question arises as to whether all of that isolating of a particular person or creating league tables of doctors, dentists or nurses, HCPs [healthcare professionals] — is that fair to the person concerned?” asks Mr O’Connor. “Does that give a full picture of their work, the value of their work for their patients; does that type of thing encourage disclosure, which we can only achieve on a voluntary basis, or does it discourage it? And those are important considerations that would have to go into that type of thing. The media do like to have league tables… from schools to doctors, to this, that and everything, and the question really arises: Do those things help?”

Payments to healthcare professionals registered on the ToV register are described under broad categories. The category of ‘Contribution to costs of events’ includes sponsorship, registration fees and travel/accommodation. The category of ‘Fee for service and consultancy’ includes fees and related expenses. The specific nature of the event attended, or consultancy/service proffered, is not detailed.

Payments to healthcare professionals, reported in accumulated form, range from two-figure sums to many thousands of euro. <strong><em>MI</em></strong> contacted a number of doctors listed on the register to seek their views on the initiative and on managing the doctor/pharma relationship.

On the page of Actelion UK Ltd, the highest amount in the healthcare professional section for 2016 is €13,514 (€10,589 fees; €2,925 expenses) to Prof Sean Gaine of Eccles St.

Prof Gaine is Consultant Respiratory Physician at the Mater in Dublin, where he established the National Pulmonary Hypertension Unit. He tells <strong><em>MI</em></strong> he fully supports transparency. However, he notes that “if you are transparent and some are not, the only focus is on those who are transparent — and that can be quite invasive or intrusive to somebody”.

He observes that a number of pharmaceutical companies have taken the position that they will not work with healthcare professionals who are not transparent, which, as he suggests, may effectively address the data protection issue in time.

“And also, the transparency really doesn’t tell you an awful lot about what’s involved, what the details are,” points out Prof Gaine of the IPHA register.

“It can look bad without being in a position to explain the nature of the funding, what it was for, and so on. I think it needs to be modified from what it is at the moment.”

Prof Gaine is highly active in the area of pulmonary hypertension, a relatively rare condition. He says he is often invited onto steering committees and advisory boards for new drugs. Much of his payments relate to flights and accommodation, he adds.

“In an Irish context, I’m always delighted to be involved in drug development or in steering committees and so on. I think it’s an honour as an Irish physician in our system to be invited onto these international panels and to be able to get an idea of what’s happening and be able to bring drugs to Ireland earlier or be able to make sure we are on clinical trials and so on, because you are influential in there.”

Actelion is “very actively involved in pulmonary hypertension and there was a clinical trial with a new drug [where] I’d been involved in the steering committee. We have a number of publications from that. And as a result, you end up being asked to talk about those publications and what the implications of them are.”

Most doctors have some form of interaction with pharma and there is a well-established risk of bias arising from this.

Prof Gaine says it is important to have “insight” in this regard. “I think you have to admit up-front that you can have biases as a result of involvement with companies. And then you have to think, what is the implication of that bias that one might have? The tools that we have are, one, being aware that it can happen and being open to the idea it can happen, and second is this idea of transparency… ”

On the AbbVie page of the IPHA register, in the healthcare organisation section for 2016, Ronan Kavanagh Unlimited of Galway Clinic, Doughiska, is listed as receiving €75,780 (€74,490 in sponsorship; €1,290 in fees).

Dr Kavanagh, Consultant Rheumatologist and founder of the dotMD conference, confirmed to <strong><em>MI</em></strong> that “the figure is a composite of three separate payments; two honoraria for speaking engagements, and the bulk of the figure, €74,490 (inclusive of VAT), relates to sponsorship for the dotMD conference in 2016”.

Dr Kavanagh pointed out “that the sponsors have no influence on the selection of speakers or topics covered at dotMD, and none of their products are mentioned in programme or promotional material for the conference”.

On the AstraZeneca page, Dr Tony O’Sullivan, a GP in Irishtown Medical Centre, Dublin, is listed as receiving €3,000 in fees for 2016. He says this was for “giving talks [to doctors] basically, quite a few of them”.

“They have a big range of products, including several that are quite useful in diabetes. I have an interest in diabetes… and I suppose within general practice, because I have run a diabetes course for many years, and I still do, people see me as someone who has an inside knowledge about diabetes. They invited me to give a few talks and they paid me.”

He says a huge proportion of doctors’ ongoing education is funded by the pharmaceutical industry. “Without it, we are on a very difficult path. So, for example, right now I am sitting here doing an online cancer course, which is absolutely independent. I know the people who set up the online course and that course is fully funded by one of the pharmaceutical companies.

“Often, readers would look at this and say ‘this is wrong, the companies are adversely influencing a doctor’s prescribing choice’. They also have to consider the other side of the coin, which is that doctors need to be well informed to make the right choices.”

He says there should be more State-funded ongoing education for doctors. “I remember asking [former Minister for Health] Mary Harney when she was bringing in competence assurance. I said, ‘okay, look, this is going to bring on a fairly substantial educational need; who is going to pay for that?’ She sort of looked at me — and it wasn’t going to be the State, anyway.”

So how does one guard against interaction with pharma having an influence on prescribing?

“We have got a certain amount of common sense to start off with,” answers Dr O’Sullivan. “I think the days when, let us say, pharma who are supporting educational activities have a direct influence on what is being said or being spoken about — those days are gone as a result of the IPHA controls. And I think most doctors now would smell a rat immediately if, let us say, the speakers were people who were very strongly linked to particular companies… or if the subject matter was ‘how great this drug is’ for such a condition. I think, although things have an impact, in general the way we do it is we get the money from the company unrestricted and then decide what we are going to talk about… ”

While Dr O’Sullivan agrees that pharma companies want to make doctors aware of their products, he reasons that at conferences, this will comprise exhibition stands that delegates might see or visit while having a coffee.

Overall, Dr O’Sullivan would prefer a mandatory register and some context to the ToV payments.

<h3 class=”subheadMIstyles”>Legislative proposal</h3>

Fianna Fáil Spokesperson on Health, Billy Kelleher TD, has brought forward a Bill that would provide for a statutory declaration by doctors who receive “gifts or donations” from pharmaceutical or other companies in the healthcare sector. The Medical Practitioners (Amendment) Bill 2017 would require declarations for ‘gifts’ worth over €600 and this process would be recorded on a register at the Medical Council.

In introducing the Bill, Deputy Kelleher said that “when doctors prescribe a type of medication, we need to know that this decision has been taken based on clinical terms and not in terms of which company has made gifts or donations to the doctor”. However, he added that he did not “for one second” believe that doctors here were prescribing medication, services or products based on gifts they had received.

Dr Andy Jordan, Chairperson of the NAGP, says the Association did not adopt a position on the IPHA ToV register, although he personally has “no problem” with such payments being disclosed on a register.

But the suggestion that the Council would maintain a register is not one he views favourably. “Everything the Medical Council does is a cost to GPs [and all registered doctors]. Who would pay for it?”

Dr Jordan says it could also create extra work for doctors if they were expected to file ‘annual returns’.

“If people want to legislate and regulate, then the people who want it should pay for it,” adds Dr Jordan, noting that this is his personal view.

Like many doctors, Dr Jordan is sometimes visited by reps at his practices in south Dublin.

“If they have an interesting or new product, or something that required a bit of time, we would set up a lunchtime meeting where we’d allow them to come in and run a meeting in the practice, and maybe invite some of the local GPs in as well. Sometimes they might even get a speaker to come. We would facilitate that, but we wouldn’t get paid for it.”

Dr Jordan finds these sessions helpful and insists that “very few people” would be “overly influenced” by this type of doctor/pharma relationship in terms of prescribing practice.

“Everybody tends to prescribe the appropriate medicine to the appropriate problem at the appropriate time,” he maintains. In respect of funding of continuing medical education, Dr Jordan also believes the “State and the HSE haven’t stepped up to the plate at all here”.

On 11 February last, writing in the<em> Sunday Business Post</em>, the head of the HSE Medicines Management Programme Prof Michael Barry stated that “there is, in my view, no role for the pharmaceutical industry in the education of doctors… The medical literature shows that doctors who interact more frequently with the pharmaceutical industry have poorer prescribing habits and are less likely to follow independent guidelines.”

On Deputy Kelleher’s Bill, a spokesperson for the Medical Council said “this is a legislative proposal that has been tabled and is now subject to discussion outside of the Council”.

Asked if the Council had issued any correspondence to registered doctors, encouraging their consent to release data for the IPHA register, the spokesperson said it had not done so.

The Private Members Bill brought by Deputy Kelleher in the Dáil in March 2017 commenced Second Stage hearings in the Dáil on 23 October last.

A Department of Health spokesperson commented: “Departmental officials consulted with the Medical Council and the HSE in advance of Second Stage. IPHA also sent its position paper on the issue to the Minister and its representative met Departmental officials to outline the key aspects of its ‘Transfers of Value’ initiative.”

In 2016, the <em>Sunday Business Post</em> investigated the extent of pharma payments to healthcare professionals and institutions and the associated lack of transparency.

In November 2016, following this report, the Department’s Secretary General Mr Jim Breslin wrote to HSE Director General Mr Tony O’Brien, informing him that Minister for Health Simon Harris “requested that the HSE undertake an assessment of existing protocols and practices” around this area and to consider whether there was a need for any additional guidance or code of practice.

Mr O’Brien wrote to Mr Breslin in February 2017, outlining four relevant protocols, namely the HR Codes of Standards and Behaviour (that employees do not receive benefits from a third party that might reasonably be seen to compromise their personal judgement or integrity and that benefits be disclosed to a superior); National Financial Regulations (similar to the above provision); the Ethics in Public Office process (all employees in the HSE above Grade 8 must disclose an interest that could materially influence them in the performance of official duties); and the annual controls assurance process (a statement/questionnaire of Grade 8 staff and above, including clinical directors, to confirm compliance with HSE financial controls and other governance arrangements).

Mr O’Brien said a number of actions would be taken to improve “awareness and compliance”, including considering extending the annual controls assurance process to include medical consultants and NCHDs from 2017, and arranging a suite of training and information sessions through HSE HR.

By press time, the HSE had not responded to a range of queries from <strong><em>MI</em></strong> on the topic of pharmaceutical payments to doctors and sponsorship of educational activities.

<div style=”background: #e8edf0; padding: 10px 15px; margin-bottom: 15px;”> <h3 class=”subheadMIstyles”>The road less taken: Psychiatrists’ body ended pharma sponsorship</h3>

There is a strong pharma presence at most national and international clinical conferences, where companies provide event sponsorship. However, the College of Psychiatrists of Ireland no longer accepts any funding from the industry.

In 2010, the Council of the College passed a motion that it would “cease receiving any sponsorship from pharmaceutical companies of its academic meetings or other activities”.

Consultant Psychiatrist Dr Miriam Kennedy, the College’s Director of Communication and Public Education, tells <strong><em>MI</em></strong> it recognises the contribution of the pharmaceutical industry towards areas such as research. However, it “became particularly important to have an independent, autonomous view towards our training and teaching, and not to be unduly influenced by strategies that might impact on prescribing”.

She says trainees and members are free to attend educational events of their choosing. However, as a training and membership body, the College does not believe it should be “endorsing” meetings organised and branded by pharmaceutical companies. The College, therefore, does not recognise such meetings for external CPD accreditation.

“I know that sometimes the pharmaceutical companies will host an event with useful presentations and you think ‘gosh, that is a speaker I wouldn’t get to otherwise’, and they may be a very, very good speaker. But the College has specific demands and protocols around these types of educational talks, in terms of promotional material and other aspects that must be adhered to for CPD accreditation to be valid. So the clinical or academic content is completely separate from any company promotional activity at the event. And there are a number of guidelines that we give to people to remind them of that.”

The hosting of conferences and educational events by the College has increased in recent years, as have levels of attendance and participation, according to Dr Kennedy, who detects no “adverse consequences” arising from its decision on ending pharma funding or sponsorship.

Dr Kennedy says the <em>Sláintecare</em> <em>Report</em> has a recommendation on developing the research capacity of clinicians, and others working in healthcare, and the College subscribes to this need.

Psychiatry is one of the specialties that the public most associates with being in the ‘pocket of pharma’ or perceives there to be an ‘undue influence’. Dr Kennedy says patients do raise this, but not as frequently as in the past.

Dr Kennedy recalls an experience as a trainee in psychiatry, which likely resonates with many doctors. She attended a major meeting of psychiatrists in the US, having received pharma sponsorship to do so. “I wouldn’t have got there otherwise — 40,000 psychiatrists, lots of presentations, great speakers”, but she was “uncomfortable at a certain point” regarding expectations to attend social events organised by the company.

She personally thinks that the current College guidelines leave boundaries clearer for all parties.

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