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Neurologists appeal to health secretary over withdrawal of drug for MS patients

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7449 (Published 02 November 2012) Cite this as: BMJ 2012;345:e7449
  1. Jeremy Laurance
  1. 1London

Three neurologists have called on health secretary Jeremy Hunt to intervene after a drug company withdrew off label use of its drug alemtuzumab for patients with multiple sclerosis ahead of trial results into its efficacy.

The doctors said they are disappointed by the actions of Genzyme, a subsidiary of the multinational drug company Sanofi. One called the company “morally corrupt” for disrupting the treatment of patients in favour of future profits.

Genzyme funded two trials of alemtuzumab that were published in the Lancet.1 2 These found that alemtuzumab dramatically cut the relapse rate compared with the current most effective treatment, interferon beta-1a.

Researchers from the University of Cambridge announced that they had found the best treatment yet for multiple sclerosis, which had a “transformative” effect on patients. Alemtuzumab could be suitable for up to two thirds of the 6000 patients who are newly diagnosed each year, they said.

Alemtuzumab was developed as a treatment for leukaemia at Cambridge University in the 1970s, but was later discovered to be effective in multiple sclerosis. The first patient to receive it was treated in 1991.

Since then the drug has been owned by 13 different companies, some of whom bought it to close down its development, according to Alasdair Coles, a neurologist at the University of Cambridge who led one of the trials.

Genzyme, which acquired the drug in 2004, funded the latest trials and had been “very supportive,” Coles said. Alemtuzumab is given in two courses a year apart and currently costs around £2500 (€3100; $4000) a patient.

But the culmination of 20 years’ research by the Cambridge scientists was overshadowed by Genzyme’s decision to withdraw off label access to the drug for existing patients, pending the outcome of the trials.

The decision, announced last summer, triggered a protest by Neil Scolding of the University of Bristol, Neil Robertson of the University Hospital of Wales, and John Zajicek of the University of Plymouth who wrote to Hunt appealing to him to intervene.

In their letter the neurologists said that Genzyme’s action had “serious implications for vulnerable UK patients with MS.”

Patients who had already started treatment would “not be able to get their vital second course,” and new patients might “miss their window of therapeutic opportunity” thereby putting them at risk of “progressive, severe disability.”

When licensed, the drug’s price was expected to be “15 to 20 times greater” and its withdrawal set an “inappropriate precedent.” They added: “It shows little regard for patients whose opportunity to alter the course of their disease is time limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation.”

Their letter concluded: “We think it important to bring these issues to your attention in the hope of protecting a vulnerable group of patients, and that a more humane approach to drug development in this area can be fostered, and that with your help steps may be taken to secure continued access to the drug for UK patients.”

Zajicek said he had personally treated 150 patients with the drug off label and estimated 400 to 500 had received it across the UK.

“Many of us think it is the best drug for patients with aggressive MS in the early stages of the disease. It’s the greedy behaviour of the drug company that upsets me. They are just trying to rebrand it and put the price up. It is morally corrupt,” he said.

A spokesperson for Genzyme said it had restricted off label use of alemtuzumab in multiple sclerosis to clinical trials because “any adverse event outside a clinical trial setting not only poses a risk to the individual patient but may complicate the regulatory process thereby delaying the availability of the drug for the MS community.”

The price of alemtuzumab would be established after it was licensed and would be subject to scrutiny by the National Institute for Health and Clinical Excellence (NICE). “We are committed as a company to engaging constructively in this process,” the spokesperson said.

Notes

Cite this as: BMJ 2012;345:e7449

Footnotes

  • Jeremy Laurance is health editor of the Independent.

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