Over the last few decades we have become used to the questionable practices of drug companies when profits are at stake. Recent reports on the actions of two companies still have the potential to shock.
Genzyme (part of Sanofi) is applying for a licence for their drug alemtuzumab for the treatment of multiple sclerosis. This drug, originally marketed for leukaemia, was shown to be effective for MS in 1998. Since then it has been used off licence for this condition. The drug has now been withdrawn and, according to the Independent, it will be relaunched at 20 times the price.
The Independent article outlines that three leading neurologists have written to the Health Secretary. In their letter, Neil Scolding of the University of Bristol, Neil Robertson of the University Hospital of Wales, and John Zajicek of the University of Plymouth say that Genzyme’s decision has “serious implications for vulnerable UK patients with MS.” They say patients who have already started treatment will “not be able to get their vital second course,” and new patients may “miss their window of therapeutic opportunity” putting them at risk of “progressive, severe disability.”
In the same week we read in the Daily Telegraph of a massive increase in the price of Epanutin (phenytoin) capsules. For a 28 pack of 25mg capsules, the NHS is now being charged £15.74, up from 66p. Other versions have been increased by the same margin—a factor of 23.84.
What is surprising about this case is that Epanutin has just come off patent. The right to this formulation was bought by Flynn Pharma from Pfizer. The capsules are still being made in the same factory—by Pfizer—and still bear the legend “Epanutin” on them. The price of a drug would be expected to fall once the generic form becomes available, but in this case, Flynn Pharma have taken the opportunity to bring about just the opposite scenario.
According to the WHO, a generic drug is one that is “usually intended to be interchangeable with an innovator product,” and “marketed under a non-proprietary or approved name rather than a proprietary or brand name.” Whereas the price of branded drugs is negotiated between industry and the Department of Health, there is no such negotiation for generic drugs. Pricing regulations are based upon the theory that generic drugs are being sold in an open market, therefore competition will keep prices down.
In reality, however, many drugs that are officially “generic drugs” (giving the manufacturer freedom to set the price as they choose) are not “generic” by WHO’s definition. Epanutin is marketed under its brand name, not its approved name and the drug company do not intend it to be interchangeable with other forms of phenytoin. For starters, there aren’t any other forms currently on the market, and secondly even if there were other forms of phenytoin available, the risk of catastrophic seizures and the precise dosing that is required would limit the possibility of changing patients on to the alternative form of the drug. The total annual cost to the health service due to the price increase of Epanutin alone is predicted to be in the region of £44.4 million (a report by the Telegraph finds that the cost to the NHS will increase from £2m to £46.6m).
So, what can be done? Firstly, we can highlight the issue to other healthcare providers and primary and secondary care trusts to prevent these incidents going under the radar. Secondly, government has a role in ensuring that this loophole is closed. In our positions as healthcare professionals, we can ask the government to amend current legislation and to address the current situation where pharmaceutical companies wield disproportionate power over NHS funds.
This issues opens bigger questions, however. Healthy Skepticism exists to highlight unacceptable practices by drug companies and to promote ethical and evidence based marketing. If you’d like to learn more or do more to address the situation, please join the Healthy Skepticism mailing list to be kept updated.
Jeni McAughey qualified from Queens University Belfast in 1980. She has been working as a GP in deprived inner city Belfast for 28 years and is involved in undergraduate teaching and post graduate GP training.
Sarah Walpole graduated from Leeds University and is now working as a core medical trainee in North Yorkshire
Merav Kliner graduated from Leeds University in 2007 and is a specialty trainee in public health in Yorkshire and the Humber. She was founder and a keen member of PharmAware and Healthy Skepticism UK.