How does Big Pharma influence mental health?
Across the EU, the pharmaceutical industry exerts influence on how we see mental health and mental illness. What do we need to look out for?
Everyone who has even a passing interest in mental health will be aware that many worry about the influence of pharmaceutical companies on how mental health is understood and treated. When the objectives of pharmaceutical companies and healthcare systems align, medical advances are possible and human suffering is reduced, but can we be certain who is charge: patients and medical professionals or pharmaceutical companies?
Many know enough to feel suspicious of the motives of ‘Big Pharma’, seeing their influencing hand in every negative aspect of mental health debate. Earlier this year European non-governmental network organisation Mental Health Europe published Shedding Light on Transparent Cooperation in Healthcare: the way forward for sunshine and transparency laws across Europe. The first part of a larger EU project, it aims “to raise awareness about the importance of transparency in the field of mental health and to encourage the adoption of sunshine and transparency laws across Europe.”
Marcin Rodzinka is Advocacy and Policy Officer at MHE and one of the co-authors of Shedding Light. “What I think is important here,” says Rodzinka, ”is to be aware that there’s a risk for patients and for users to mental health services that decisions that are made in the treatment process can be influenced by basic lobbying by the pharmaceutical industries. Sometimes in mental health we can face over-reliance on medication. They are treated very often as the first help for patients and first treatment methods and we observed mental health care over-medicalisation.” Doctors, says Rodzinka, can be “biased by undue influence of the pharmaceutical industry that has the first interest of the industry is basically to sell more medication and to have more profit out of it. In mental health you don’t really have breakthrough discoveries recently. So there’s no medication they can advocate for because everything is generic almost and everything is quite cheap. So they will do everything that they are allowed to and sometimes even illegal practices are in place to maximize their profits.”
Shedding Light divides interactions between the pharmaceutical industry and healthcare professionals and health care organisations into two main categories: research-oriented interactions and promotion practices. Research-oriented interactions are where Pharmaceutical companies pay for, partner on, or otherwise support research. Far murkier are promotion practices, which can cover everything from a free lunch, to a helpful bit of training, to some sponsorship of an event or project, to a visit from a pharmaceutical company rep.
How does big pharma influence medical behaviour?
Shedding Light identifies seven ways that close relationships with, or influencing by, pharmaceutical companies compromises the mental health care and support people receive. Many of these relate to the broadening of sales of existing medications. “It’s quite a long time that no new medicines were introduced to the market,” says Rodzinka. Involvement in research is one of the most obvious ways pharmaceutical companies influence mental health treatment. Many are aware that this can generate biased reporting of trials; downplaying of side effects and exaggeration of positive ones; and bias within the creation of research itself “Companies very often are trying to resell and promote old medicines and they don’t see hope in investing in Psychiatry and research in psychiatry.”
Influence is a difficult thing to quantify. The objective is to change how people see a particular issue. To do this requires access. Says Rodzinka: “In many many countries medicine and practice is under-financed so industry uses this as an argument to provide funding for practitioners and doctors to enable them to attend conferences, to enable their education, to provide them with additional materials.”
Shedding Light argues that greater independent funding should be available for research; for the continuing education of healthcare professionals and for charities and patient organisations. More funding will make it less necessary to enter into potentially compromising relationships with the Pharmaceutical Industry. The report recommends that independent research funding needs to be increased to reduce reliance upon pharmaceutical industry partnerships. The report also suggests the answer to influencing of doctors via education is support initiatives offering “independent and continuing medical education to initial and continuing medical students and healthcare professionals.”
Information, training or education developed with, or influenced by, pharmaceutical companies may mislead or misrepresent the benefits of certain medications over other forms of treatment. Rodzinka says that such training and professional development is often supported by pharmaceutical companies across Europe. While this does not influence directly, it contributes to a sense of the reality of mental health which may present certain arguments or evidence over others. Shedding Light claims that this can be observed in psychiatry, “where a worrying reliance on medication as the main form of treatment for mental ill health takes place. This unbalanced relationship may reinforce a narrow biological conception of the nature of mental health, which understates the adverse effects of psychiatric drugs.”
A systematic review published in the British Medical Journal in 2017 concluded that “Physician–pharmaceutical industry and its sales representative’s interactions and acceptance of gifts from the company’s PSRs have been found to affect physicians’ prescribing behaviour and are likely to contribute to irrational prescribing of the company’s drug. Therefore, intervention in the form of policy implementation and education about the implications of these interactions is needed.”
In the UK we are protected by the Bribery Act 2010 from direct financial inducements, so influence is far less easy to regulate and spot. The UK has fairly robust laws against undue influence on medical practice. NHS England guidance for managing conflict of interest requires disclosure of any gift or service over a certain financial level and advises that, in essence, if in doubt, don’t accept items, travel, training, sponsorship or other supports if it may be seen to influence professional decision making. Conflict of interest is defined for the purpose of guidance as “A set of circumstances by which a reasonable person would consider that an individual’s ability to apply judgement or act, in the context of delivering, commissioning, or assuring taxpayer funded health and care services is, or could be, impaired or influenced by another interest they hold.”
Shedding Light states that exposure to pharmaceutical company representatives themselves may influence which medications an individual healthcare professional prescribes, and whether they are likely to turn to these medications first over other forms of help or support. The authors also identify the potential for key opinion leaders who also work with, or for, pharmaceutical firms influencing the development of clinical practice guidelines
Shedding Light notes that pharmaceutical companies wish to increase the market for their products so may lead them to inflate the prevalence of certain conditions, or “by narrowing the definition of health (so that normal experiences get labelled as pathologies) or by expanding the definition of disease (in order for milder or presymptomatic forms to be treated as a full-blown disease).” This may also lead to suggestions for off-label uses or to support the patient or other groups in lobbying for more expensive or less effective drugs to be provided as part of healthcare systems.
Big Pharma in the age of influencers
Influencing the market for pharmaceutical does not only involve direct interaction with healthcare professionals, government bodies or regulators.
Charities, too, can be an avenue for influencing, as can patient groups, although Shedding Light does not contain any details about this. Pharmaceutical companies still provide money to charities and patient groups, mostly as corporate social responsibility, says Rodzinka, “to raise awareness for medication and to mainstream use of medication and to promote medication itself.” In the UK it’s rare for charities or service user groups to directly promote medications or call for wider availability of drugs. “Industry,” says Rodzinka, “doesn’t say to the charity on what they should spend money. They are free to use this money as they want. More like awareness-raising campaigns or general activity but not advocacy or lobbying itself.”
Not everyone who can influence opinion about mental health medications is a healthcare professional or charity employee. Rodzinka mentions social media as an area where public opinion can be shaped. “What we seen now happening is that you have on social media you have a lot of people sharing their personal experiences. which is super super useful and that than and it’s great that it’s happening. The narratives is that again I was saved thanks to medication, medication helped me survive. If not for medication, I wouldn’t be here today and so on.” Rodzinka suggests that some people may be paid by Pharma companies as influencers on social media, but Shedding Light does not contain any details to back this up. “It’s not in product placement, that’s not the goal. It’s patients who already have a strong position in the community who were previously involved in some special organizations or groups, but now they became so popular they became kind of advisers to the industry but still being a patient.”
Rodzinka says transparency, through what are called sunshine rules or laws, is about “‘are people allowed to make informed consent and having trustworthy knowledge about different options?’ And then based on that they can make a choice about what’s really best for them. We don’t want to leave patients and users alone with this information. What do they do if they’re taking medication but then they discovered their Psychiatrist or doctor was paid by Pharma, then what do they do? They discard medication, stop taking it, then they are at risk.”
Removing grey areas
How much activities to influence the prescription and licensing of mental health medications are actively effective is difficult to gauge without a greater level of transparency. Different EU member states have different laws regulating pharmaceutical industry influence and different systems of healthcare, so what is true in one country may not be true in another. There are currently no legally binding EU level laws regarding obligation to disclose pharmaceutical industry gifts, support or other means of potential influence. Directive 2001/83/EC — widely known as the Pharmaceutical Code — regulates the pharmaceutical market in the EU. The Directive states that advertising significantly contributes to the information available to healthcare organisations, healthcare professionals and other organisations and “as such remains desirable. Nevertheless, it should be subject to stringent conditions and effective monitoring, as health professionals must be able to perform their functions objectively, without being influenced by direct or indirect financial incentives from industry.”
One of the key recommendations of Shedding Light is a harmonised set of EU level laws governing the disclosure of all gifts, support and influence of pharmaceutical companies.
Any person in the EU should be able to easily find out if any healthcare professional, organisation, charity or group has received anything from a free sandwich or pen up to sponsorship, funding or support from any part of the pharmaceutical industry.
Shedding Light recommends that full or near-full disclosure should be the legal norm across Europe and that this information should be published in public databases with tools to make it easy for an average member of the public to find out how any individual has interacted with potential pharmaceutical industry influence.
Trust needs openness and not every cooperation is a bad one
Rodzinka is keen to point out that the goal of greater transparency and regulation is not to become like the anti-vaccination movement, seeing conspiracy and malign influence at every turn. “We don’t want to be those people that say that the whole industry is just nasty and whatever they do is bad. We as Mental Health Europe work with all of them. When we started this project we invited patients, users of mental health services, we invited pharmaceutical industry. We invited medical devices companies, medical students, doctors, to be in a dialogue.” Rodzinka says the job is “not to play this game that we are blaming and shaming these people but really that we are aware of things that are just not right and things that are just not as they should be and whether we can actually do something together.”
Rodzinka says people who experience mental health difficulties should have “a better picture of the scale of the influence of the industry and then be able to do something more with this.” MHE intends “to work closer with users to empower them and encourage them to be more critical in a positive sense; to ask more questions about what they are prescribed and what they are advised. it’s super important for you to find the balance, just to really to put all methods of helping people and supporting people on the same level and not to overuse any of them.”
For the authors of Shedding Light, better funding of mental health across Europe and stronger laws governing disclosure will remove both temptation and increase scrutiny. “We acknowledge that medication is very useful and and does help people,” says Rodzinka, “But at the same time we see that it’s over-used very often. Actually, it can harm people.” Where people with mental health difficulties may feel a lack of power, it is even more important that advice and decisions about medication can be trusted.
Rodzinka says the next stage is to work with people with mental health difficulties on how to approach this “and of course to make them aware that not every cooperation is a bad cooperation.” The authors of the report are keen to point out that while some level of cooperation between the pharmaceutical industry and healthcare professionals or organisations is inevitable and can be beneficial, the majority of these interactions remain opaque to patients and citizens. Says Rodzinka: “ It’s really about bringing more trust in medicine.”
The objective isn’t sow distrust between health care professionals and patients, but to create conditions where real trust is possible. Says Rodzinka: “By this strong lobbying of the industry we find ourselves in this narrative that pills will just make us healthy. To build and to strengthen trust between patients and doctors we need to know with what and with who doctors cooperate, to really have the whole picture.”
@markoneinfour
