Politics and Healthcare – still a volatile mix
pharmafile | December 22, 2005 | News story | |Â Â Â
Politics and the provision of healthcare are, it is generally agreed, ultimately inseparable; but their frequent interactions are a continual source of tension. This is particularly the case when politicians are perceived to use sensitive issues to fulfil their own agendas, or overstep the mark in to sensitive medical ethical cases.
Such flashpoints were abundant in 2005, with governments around the world trying to negotiate a range of complex and thorny issues.
In the US, a huge furore blew up around plans to make Barr Laboratories' Plan B morning after pill available over the counter in pharmacies.
The pro-life lobby, far more influential in the US than the UK (where a similar battle was fought) lobbied strenuously against its approval by the FDA.
In August, FDA chief commissioner Lester Crawford indefinitely postponed the sale of the emergency contraceptive, overruling the advice of its expert panel which had voted 23 to 4 in favour of approving the drug.
The overruling is understood to be only the second in five decades, and many blamed the intervention of Conservative politicians for the inconsistency of the final decision.
Susan Wood, the FDA's assistant commissioner for women's health resigned over the matter, deepening the poor morale at the agency, and contributing to the departure of the chief commissioner himself in September.
In the UK it was election year, and many polls showed that the NHS was the number one issue for voters, ahead of such issues as the economy, law and order and the situation in Iraq.
A deep-seated belief that the Conservatives could not be trusted with the NHS in some voters helped Labour win an historic third term, despite the similarity of their healthcare policies.
Most notably, the Tory campaign highlighting problems of the MRSA superbug in hospitals backfired badly when NHS leaders said the figures the party quoted were misleading and unhelpful.
Herceptin
For the pharmaceutical industry, the single biggest political bone of contention in 2005 was the controversy surrounding access to Herceptin.
Newly appointed health secretary Patricia Hewitt quickly made her mark by openly bypassing NICE and its board and ordering a fast-track appraisal of Roche's breast cancer drug.
Since that first intervention in July, the health secretary has continued to intervene in calls for access to the drug for women with early breast cancer – despite the fact that it is not yet licensed for this indication.
Hewitt has made it clear that PCTs should not refuse to fund Herceptin solely on the grounds of cost.
"I know that some PCTs are already under financial pressure and may have to make difficult trade-offs in priorities to fund this new treatment for women who want it and whose clinicians want it for them," she said in October. "Although that will not be easy, I believe it is the right thing to do, particularly as they will be managing it over two financial years."
Two direct interventions in local PCT decisions to deny the drug to women with early breast cancer has brought opprobrium from healthcare professionals and NHS leaders, and even UK pharma industry association the ABPI.
ABPI commercial director Martin Anderson told a PM Society meeting that Hewitt's move sent out very mixed signals about drug regulation.
"Six months ago the industry was being castigated for putting a dangerous drug on the market [Vioxx]. Now with Herceptin there is a clamour to have an unlicensed medicine available on the NHS. The Secretary of State wants everybody to have a drug that we don't really know works or not."
The intervention divided opinions deeply, with cancer charity CancerBACUP supporting the action, while The Lancet ran an editorial calling for 'cooler heads – cooler than have so far prevailed, in politics, in public, and even in medical journals', the latter a reference to an editorial in its rival NEJM which called the drugs data simply stunning.
Independent health think tank The King's Fund has added its voice to the dissent, saying Hewitt's circumventing of NICE could actually expose patients to risk since the European regulator has yet to even receive clinical data from the manufacturer.
Secondly, it says the health secretary has undermined local NHS decision-making and NICE, which was supposed to provide independent clinically-based decisions.
The think tank concluded: "Despite its rhetoric on increasing local autonomy in the NHS in general, the government has clearly indicated that, in this case, the centre knows best."
One thing seems certain: until politicians are no longer elected to improve healthcare and are ultimately accountable for patient well-being and safety, politics and healthcare will be as intertwined as ever.
Related links:
Health secretary backs Herceptin use
Thursday , November 10, 2005
