The legal loophole that means doctors don’t have to declare if ‘independent’ research is actually funded by a drugs giant
When you take a powerful medicine, or have a medical device implanted in your body, you want to be sure its safety and effectiveness credentials are backed up by independent studies.
That is, free from medical companies’ efforts to oversell the benefits or, worse, cover up the fact that their products may be useless or even potentially harmful.
Yet numerous studies show commercial money significantly influences researchers to sway clinical trial results in favour of the drug or device they are testing.
For example, one study found antidepressants were better than talking therapy when a drug company funded the research; while another found that doctors who received a free meal from a drug company were more likely to prescribe more of the company’s drugs.
In the U.S., the Physician Payments Sunshine Act — passed into law in 2010 — requires all medical companies to disclose payments made to researchers and healthcare professionals, so they can be scrutinised by independent experts. Here, no such law exists.
Numerous studies show commercial money significantly influences researchers to sway clinical trial results in favour of the drug or device they are testing. File image
Instead, it is at the discretion of the researcher or company to disclose any fees, sponsorship, expenses or other forms of financial backing. Very often, evidence shows, they choose to keep this information secret.
The Government has repeatedly promised that financial openness legislation would be put in place this year, following scandals such as vaginal mesh implants — which left tens of thousands of women physically and mentally damaged.
The net-like surgical mesh came into routine use in the UK in the late 1990s, mainly as a support for the bladder in women with severe urinary incontinence.
And this is how it ca affect you…
- Research in the British Journal of Psychiatry in 2017 examined 45 trials comparing talking therapy with antidepressants. It found that if the trial was sponsored by a drug company, it was consistently more likely to favour the drugs.
- A 2016 study of 279,000 U.S. doctors, published in the journal JAMA Internal Medicine, found that even receiving one free meal from a drug company made them prescribe significantly more of the company’s drugs.
- Research in the journal Tobacco Control in May, by Bath University, found numerous articles and commentaries published in journals lacked explicit declarations that they had been funded by the tobacco industry representative group, the Foundation for a Smoke-Free World (FSFW).
Researcher Amy Lunt told Good Health: ‘The evidence shows UK-based researchers have accepted industry-related funding and have not been fully transparent about their links to the tobacco industry.’ A spokeswoman for FSFW said it receives ‘annual charitable gifts’ from tobacco giant Philip Morris International, but is not a tobacco-industry representative group.
But after it emerged that many thousands of women had been left with crippling pain, sexual dysfunction and injury from the implants, ministers announced a ‘pause’ on their use in 2018 (though investigations by Good Health show NHS surgeons are still implanting them in ‘special circumstances’).
A subsequent investigation, First Do No Harm, by Baroness Cumberlege in 2020 recommended Britain get its own Sunshine Act, so everyone can see details of direct payments and payments in kind (such as fees for research and attending conferences) that medical companies make to researchers, doctors, teaching hospitals and research institutions. The call reflected ongoing concerns about undisclosed financial conflicts of interest in mesh research.
Dr Ulf Ulmsten, a gynaecologist in Sweden, pioneered mesh use in women with stress urinary incontinence and pelvic organ prolapse in the late 1990s at Uppsala University Hospital, with impressive results.
Ethicon, a subsidiary of global medical giant Johnson & Johnson, then agreed a deal in 1997 with Ulmsten’s company to market the mesh, but secretly agreed to make additional payments — totalling $1 million (£795,000) — if the doctor could repeat the promising results in larger trials.
In the world of research, this can be regarded as effectively an incentive, even subconsciously, to make results look positive.
According to U.S. court evidence in 2017, Ethicon did not disclose the conflict of interest in this arrangement to doctors.
Few would argue against the UK needing the same U.S.-style legislation, but campaigners fear that ministers are deliberately fudging the issue so we may never get a useable system.
In January, the Commons Health and Social Care Committee said it had been told by William Vineall, director of NHS Quality, Safety and Investigations at the Department of Health and Social Care (DHSC), that he expected local pilot schemes to implement Sunshine Act-type openness would ‘run during 2023’.
Women’s Health Minister Maria Caulfield also promised implementation of the new system this year.But Health Minister Will Quince has since admitted there’s no date set for the necessary regulations to be put before Parliament.
A DHSC spokesman said: ‘The details of the consultation are being finalised, so I don’t have information to share at the moment.’
(Stock Photo) It is at the discretion of the researcher or company to disclose any fees, sponsorship, expenses or other forms of financial backing
Campaigners, including Dr Margaret McCartney, a GP and NHS-funded researcher at the University of St Andrews, have expressed alarm at the delays. They argue that the UK Sunshine Act system should be held by a single publicly accountable central body — most likely the General Medical Council (GMC) — and be open to all and easily readable.
However, the Government has already said: ‘We do not think that the GMC register is the best place to hold this information.’
Ministers also say their planned system would publish information ‘locally at employer level’.
The problem is that a similar system for publicly disclosing NHS conflicts of interests has been in place since 2016. Its aim is to ensure managerial-grade doctors, GPs and staff in NHS commissioning organisations don’t also have financial interests in the institutions from which they commission work. The rules require NHS bodies to publish potential financial conflicts of interest ‘in a prominent place’ online that is ‘accessible and contains meaningful information’.
But an investigation by Dr McCartney of NHS Trusts and commissioning groups in England, found three-quarters failed to provide all the information required, reported BMJ Open last year.
Those that were published were nigh-impossible for people outside NHS trusts to read, she says.
Susan Bewley, an emeritus professor of obstetrics and women’s health at King’s College London, who is a trustee of HealthSense, a charity that promotes evidence in healthcare, is also concerned.
‘There is clear evidence that payments from the pharma and medical device industries influence health professionals. Patients need to know their treatment is based on best evidence, and not on who is paying their doctor,’ she says.
Kath Sansom, who runs the mesh victims group Sling The Mesh and has led campaigning for the Sunshine Act, told Good Health: ‘The lack of progress makes us worry that ministers are just parking the reforms in the long grass. The current situation means that too often we are effectively being told a meaningless pack of lies rather than a reputable scientific study.’
Currently, there is not even a system for voluntary payment disclosure run by the medical-implant sector’s umbrella organisation, the Association of British HealthTech Industries. It told Good Health it has no plans to introduce one.
Meanwhile, with medicines, the only information on researchers’ conflicts of interests is a voluntary system for researchers working on branded medicines (drugs with patents held by pharmaceutical companies).
(Stock Photo) One study found antidepressants were better than talking therapy when a drug company funded the research; while another found that doctors who received a free meal from a drug company were more likely to prescribe more of the company’s drugs
This system, run by the Association of the British Pharmaceutical Industry (ABPI), is called Disclosure UK. But because it is only voluntary, researchers can opt out of having their payment details made publicly available. Nor does the system highlight if a doctor or researcher has opted out.
Past figures from the ABPI show that in 2018, for example, four out of ten professionals on the Disclosure UK database withheld information about any payment or relationship without having to give any reasons for so doing.
Kirsty Gelsthorpe, spokeswoman for ABPI, told Good Health the numbers withholding information are falling. ‘We expect that to continue,’ she says. ‘Last year, an estimated 72.6 per cent of healthcare professionals were named, leaving 27.4 per cent that weren’t.’
But that means that one in four researchers is still withholding information about their receipt of pharmaceutical-company payments or other commercial relationships that benefit them.
Why would they withhold?
As Baroness Cumberlege told Good Health: ‘The public have a right to know when the pharmaceutical and devices industries pay clinicians or fund research. They also have a right to know where doctors receive income.
‘In my review we called for a register of payments by industry to doctors, and the declaration of financial interests by doctors themselves. That was three years ago — I am keen to see progress.’
Johnson & Johnson told Good Health Dr Ulmsten’s trials were perfectly independent. ‘In the 20 years that have passed since the study was published, hundreds of studies with no connection to Dr Ulmsten or Ethicon, including over 100 randomised, controlled trials, have evaluated the clinical performance of TVT [tension-free vaginal tape], further validating its safety and effectiveness.’
Source: Read Full Article