Lois Rogers

Journalist and Communicator

Dying beg to become medical guinea pigs

Health Policy

 

The Sunday Times 14 April 2013

A COALITION of influential medical figures is to spearhead a campaign to allow the terminally ill access to unlicensed experimental drugs.

The Right to Try campaign has been inspired by Les Halpin, a millionaire who is suffering from motor neurone disease (MND), a degenerative condition of the nervous system. Halpin has ploughed his fortune into winning the right for the terminally ill to become guinea pigs for unlicensed drugs, both to try to save themselves and future sufferers.

Under the Halpin protocol, patients would waive all rights to sue doctors and pharmaceutical companies in return for being prescribed experimental drugs. Regardless of the outcome, drug firms would be required to make the trial results public to help the search for a cure.

About 3.5m people suffer from one or more of 6,000 conditions classed as “rare”. The low number of sufferers of each condition dissuades pharmaceutical firms from investing in research because returns would be low.

Halpin is unlikely ever to know whether the campaign, which launches at Westminster tomorrow and is likely to require legislation, succeeds.

“For people like us, who know that without treatment we’re going to die soon anyway, attitude to risk is different,” he said. “If there is the slightest chance that a drug might help you, even with the chance of side effects, you would still take it.”

Supporters of Halpin’s campaign include Baroness Finlay, former president of the Royal Society of Medicine, Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, and Professor Sir Peter Lachmann, emeritus professor of immunology at Cambridge and former president of the UK Academy of Medical Sciences and the Royal College of Pathologists.

Lord Howe, the health minister, said the government was examining the Halpin protocol. “We are currently exploring ways this can happen while protecting the safety of patients,” he said. “We have [already] consulted on a scheme which aims to make new and promising medicines available to patients in the UK around a year before they are licensed.”

Many patient groups and doctors say a climate of fear over the cost of developing drugs and of any legal action has created a logjam in the emergence of new medication onto the market.

Laws introduced following the scandal over thalidomide, a drug taken to help alleviate morning sickness that left 10,000 babies in 46 countries with physical deformities, are in part to blame because drug companies can now be sued over side effects they could not have foreseen.

“We are in a golden age of scientific progress but drug development has fallen fiftyfold because of insane regulation,” said Lachmann. “Thalidomide is an example of a disaster that has given rise to other disasters which are much worse.”

Halpin’s initiative follows an attempt by Lord Saatchi, the advertising tycoon, to change the law. Following the death of his wife, the novelist Josephine Hart, from untreatable ovarian cancer in 2011, he recently introduced his own Medical Innovation Bill in the House of Lords.

The bill proposes that doctors be allowed to practise “responsible innovation” by using experimental treatments approved by a multidisciplinary team at their hospital and overseen by one doctor. He hopes his legislation can be amalgamated with the Halpin protocol and become law within two years.

“I think there would be a cure for cancer by now if it weren’t for the blockages in the system preventing innovation,” he said.

Change cannot come too quickly for John MacGlashan, an electrician from Dunstable, Bedfordshire. His three-year-old daughter Lilly was born with neuroblastoma, a form of cancer affecting only 100 children a year. She has been kept alive with £1m worth of experimental drugs provided by a hospital in America and paid for by charitable donations and funds from Lilly’s own family.

“All the NHS keeps telling us is that the treatment is not proven and they can’t offer it, but without it Lilly would be dead,” MacGlashan said. “There is actually nothing to stop them taking part in a trial from here [the US].”

Alison Moy, the chief executive of the Neuroblastoma Alliance, said: “Families are condemned to destroy themselves in this way simply because no one is willing to provide NHS staff with immunity from prosecution if they prescribe experimental drugs here.

“In one case, a family went to the High Court because doctors felt they would be too exposed if the child died from side effects of the drug. Although they won the case, they still ended up going to America because they couldn’t get the treatment in time. It is a simply outrageous situation.”

Written by Lois Rogers