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Mediclinic News : SA’s closet deals between doctors and drug makers

Title

SA’s closet deals between doctors and drug makers

Date

2016-12-13

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BUSINESS DAY South African patients are oblivious of the hidden hand of the pharmaceutical industry, which every year pays millions of rand in speakers’ fees, free meals and research grants to doctors and research institutions. There is no legal requirement for the companies to reveal the perks they give to medical professionals, nor are they willing to volunteer the information. In contrast, US law requires these same firms to publicly disclose their payments to doctors and teaching hospitals. They do so voluntarily in the UK as part of a Europe-wide move towards greater transparency, as well as in Japan and Australia. The lack of disclosure in this country leaves consumers in the dark about whether drug companies may be inappropriately influencing the prescribing habits of doctors. Nor do they know what conflicts of interest the experts may experience who advise the Medicines Control Council (MCC) whether or not to allow drugs onto the market, or those who draw up treatment guidelines for diseases such as hypertension and asthma or compile the government’s list of approved medicines for hospitals and clinics. Medical Research Council senior scientist, Tamara Kredo, said there is global debate about the impact of this funding on the independence of those receiving the funds. Citing treatment guideline development as an example, she said poor reporting on conflicts of interest potentially erodes the trust that patients and the public place in clinicians. Recent analysis of the US Open Payments database found that doctors who received free meals from drug companies were more likely to prescribe their medicines than cheaper generic rivals, and that fancier meals were associated with the highest prescribing rates. The study, published earlier this year in the journal JAMA Internal Medicine, examined 63 000 payments made to nearly 280 000 doctors over a five month period. Most received fairly cheap meals, ranging between $12 and $18. The database, which has been operating since 2014, shows that more than 618 000 physicians and 1 100 teaching hospitals collectively received more than $7.52-billion from drug and device makers last year. More than half that amount ($3.9-billion) funded research - the rest went to speaking and consulting fees, meals and gifts. Huge sums are paid out in other countries too: the top 10 pharmaceutical companies in Japan spent $1.63-billion on healthcare professionals and researchers in 2013, while Medicines Australia recorded $A64-million in similar payments in the 12 months to April 2016. BUSINESS DAY asked six multinational pharmaceutical companies to disclose the nature and size of the payments they made to doctors and researchers in SA in 2015. None were willing to do so. Abbott ignored several e-mailed requests for comment. Novo Nordisk and Eli Lilly said they could not disclose the information because it would breach confidentiality agreements and data privacy laws such as the Protection of Personal Information Act. Pfizer said there was no legal requirement to publish payments to researchers. However, this information was fully disclosed in clinical trial applications to the MCC and to the ethics committees that approve these projects. Pfizer spokeswoman Charmaine Motloung recommended approaching the relevant ethics committees for the information. Sanofi-Aventis would need consent from all the healthcare professionals involved to publish the data, said its spokeswoman for SA, Prudence Selani. She declined a request to provide aggregate data that masked the identities of the healthcare professionals. GlaxoSmithKline, which discloses payments to doctors in the US, Japan, Australia and Europe, declined to provide data for SA. its GM for South and Southern Africa, Davies Gichuhi, said the company will work with the industry and government when they are ready. Eli Lilly’s MD for SA and sub-Saharan Africa, Ann-Marie Hosang, said in principle the company supported public disclosure of payments to healthcare professionals in SA, provided it was governed by an appropriate regulatory framework. She declined to provide information on its payments to healthcare professionals in SA. Local generic drug manufacturer Adcock Ingram was equally reticent. Spokeswoman Vicki St Quintin would not provide details of the payments the company made to doctors, but said the company complied with the guidelines drawn up by the Marketing Code Authority, a voluntary industry association. Aspen Pharmacare, another local generic manufacturer, was the most forthcoming. The company paid R883 000 in speakers’ fees to healthcare professionals last year, according to head of strategic trade Stavros Nicolaou. Some scientists, such as MCC chairwoman Helen Rees, have consistently refused to take funding from the pharmaceutical industry. She said she always thought good drugs must be used on the basis of their benefits to the patient, not on marketing ploys. Others regard it as a legitimate source of income. David Marais, chairman of the Lipid and Artherosclerosis Society of SA, said there often is suspicion about the influence of the pharmaceutical companies on the profession. However, his personal experience is that working together has ensured translation of therapeutics to patients with serious disease. He credits pharmaceutical companies with helping to provide state-of-the art treatment for patients with severe disorders and enabling university researchers to keep up to date with global scientific advances by paying for them to attend academic meetings. Marais said conflicts of interest should be declared at all academic presentations and publications to indicate potential bias, but amounts are not. He said his feeling is that this is enough and doing more, though superficially attractive, will not really be worthwhile: the profession is overburdened with administration and the system may not accurately reflect what is going on. Southern African HIV Clinicians’ Society president Francesca Conradie is frank about the payments she receives from pharmaceutical companies. She said she participates in training events - such as panel discussions to debate the pros and cons of different HIV/AIDS medications - as well as advisory boards. Fees typically range between R5 000 and R15 000 a session. Conradie said her area of interest is narrow and the choice of drugs is usually determined by the funders. She said she can’t see how the payments would make a difference, adding that she has never been asked directly or indirectly to sell a product. Conradie said researchers have to declare their conflicts of interest when they attend conferences and when they provide expert advice to the MCC. The head of the University of Cape Town’s ethics committee, Marc Blockman, said pharmaceutical industry support for doctors is not necessarily wrong. However, the lack of transparency in the South African system is a problem. He said no one does a lecture tour without being paid for it. Can we allow people to make extra money in a way that is not prejudicial to patient care? he asked. The Department of Health and the MCC are moving towards greater transparency. The MCC is exploring its options for making its members’ conflicts of interest available to their peers and to the public, said Rees. The department’s deputy director-general for regulation and compliance, Anban Pillay, said the experts who help draw up the Essential Drug List for hospitals are required to declare their conflicts of interest to the committee chair, who can ask people to recuse themselves from specific discussions. The information is not made public, but the Essential Drug List committee should consider making it so, he said. Pillay said it would be impractical to try to ban payments from drug makers to healthcare professionals, so the Department of Health supports the global move towards greater transparency. He said public disclosure should happen. It will temper the way the profession acts. The Innovative Pharmaceutical Association of SA’s CEO, Konji Sebati, said she sees no harm in public disclosure of payments to doctors. She said there is nothing to hide. IPASA is pushing the health department to legislate, she added. In the absence of legislation, the only strictures on the payments pharmaceutical companies make to healthcare professions are those imposed by the Marketing Code Authority. It has published a code that curtails some of the more egregious payments such as free overseas trips for spouses. Sebati said the authority regularly deals with complaints from its members. However, only a handful of cases are to be found in the complaints section of the authority’s website, and none related to payments to healthcare professionals. Despite the constraints imposed by the marketing code, industry sources say drug makers still pay hefty fees to individuals they identify as “key opinion leaders”. These are people at the top of their profession who wield influence over their peers’ prescribing habits. They get paid for services such as participating in advisory board meetings, speaking at conferences, and providing training. Advisory board meetings are sometimes used to help guide research into medicines or launch new products. Some prescribers also make money by becoming involved in clinical trials and receive payment for meetings to plan, monitor and evaluate the research. Opinion is divided over the extent to which these payments are justified.
Created at 2016/12/20 03:36 PM by Mediclinic
Last modified at 2016/12/20 03:36 PM by Mediclinic