Big pharma is in the dock again this morning following the publication of a Cambridge University report which details the influence companies exact "at every stage" to get their drugs reimbursed.
Research undertaken by Cambridge sociologist Lawrence King claims that drugs that do not represent value for money or are medically unproven may be increasingly reaching one of Europe’s largest pharmaceutical markets, Poland. Prof King and colleagues Piotr Ozieranski (University of Leicester) and Martin McKee (London School of Hygiene and Tropical Medicine) argue that "through direct and indirect methods, many of which remain hidden from public view", some of the world’s biggest pharmaceutical companies, as well as politicians, are exercising influence over the drug evaluation programme in Poland, which is overseen by the Polish Agency for Health Technology Assessment (AHTAPol).
The findings, published in the December issue of Health Policy, are based on more than 100 interviews with people on all sides of the process, as well as data from more than 270 scientific recommendations on drugs issued by the AHTAPol. Poland’s Minister for Health recently announced that the agency is in line to be replaced.
The research showed that an increasing number of drugs were being recommended for reimbursement, even though more than 50% of them were not deemed cost-effective at their current pricing. Furthermore, the AHTAPol found that for drugs positively recommended, the evidence supporting their cost-effectiveness was “not credible” in more than 25% of the cases, and was missing or lacking in more than 50% of the cases.
State experts snapped up by pharma firms
Dr Ozieranski said that "the most troubling finding from our research is the extent of privatisation of state expertise by the pharmaceutical sector". He added that "excellent experts, educated with public money, are almost immediately captured by the pharmaceutical industry – able to offer them a much better deal than the AHTAPol".
This loss of state expertise, coupled with the potential for ‘insider knowledge’ and personal connections being passed directly on to big pharma, could be rectified by a ‘cooling-off’ period before experts can jump ship, says Prof King.
The report's authors were also concerned by behind-the-scenes political interference. One interviewee, an AHTAPol official, said: “Sometimes there is political pressure on certain decisions, say, from various patient groups (often backed or created by the pharmaceutical companies) which accessed some places or organised media campaigns.” Another spoke of a minister asking for a change in the legal status of a sizeable group of highly-expensive reimbursed drugs - without any analysis or research.
Prof King said that the study is the first to look at health technology assessment (HTA) in Poland, a country which faces huge popular pressure at reimbursing novel drugs, as well as suffering from an underfinanced healthcare system. “The influence exerted by multinational drug companies calls into question the validity of Poland’s HTA, given some of these conflicts of interest we’ve uncovered,” he added.
The report notes that drug companies paid state experts to lecture, offered research grants and employed other incentives "to win their hearts and minds". Other methods of interference included co-opting clinical experts, patient organisations and politicians to advocate drugs under consideration by the state authority.
The authors highlight "a few promising regulations" introduced by the new reimbursement legislation in 2012, but claim that "not all improved standards for disclosure of conflicts of interests have not been implemented rigorously". They make a number of recommendations, including broader use of professional codes of conduct for experts performing HTA, comprehensive disclosure and management of experts’ conflicts of interest and "well-defined institutional separation between HTA and political decision-makers".
Prof King concludes by saying that the research "talks about the dilemmas that can be identified in any country using HTA to assist decisions about the reimbursement of new drugs, in particular the role of the drug industry in HTA".