Leading experts call on pharmaceutical industry to focus on coming up with meaningful drugs and boost levels of effectiveness.Many modern cancer drugs are of very little benefit to patients, according to a group of leading European experts, who have devised a way to score them.
Among the drugs that do badly in a table published on Saturday revealing their efficacy is Erlotinib for pancreatic cancer, which offers just 15 extra days of life.
The experts are all members of the European Society for Medical Oncology (Esmo). They presented their scoring system, which has nothing to do with cost, at a meeting in Chicago of the equivalent US body, the American Society of Clinical Oncology (Asco). The document, which includes scores for more than 70 cancer drugs, has been published in the Annals of Oncology journal.
Prof Richard Sullivan from Kings College London, a group member, said they wanted pharmaceutical companies and those who fund drug discovery to focus on inventing meaningful drugs that help patients, rather than just making profits.
He said: “Over the past decade, more and more medicines have been going on to the market with lower and lower levels of benefit.”
Not many medicines are being brought forward as potential cures, most are for palliative care. To get a licence, the manufacturer only has to show that the drug has some effect. Sullivan said: “It is easier to get a marketing authorisation in palliative disease.”
The E smo magnitude of clinical benefit scale scores drugs according to the results of the clinical trials they have been through, from one – providing the least benefit to patients – to five. Drugs that score between one and three are not doing well, Sullivan said.
He said: “Where they don’t score above three, you have to ask are they really delivering clinical benefit. There will be a lot of people saying there are some drugs that get into four that shouldn’t be there.” Because the trials are run in ideal, carefully monitored populations, the benefit in the real world is likely to be lower.
Most of the drugs in lung cancer score four, but Erlotinib, also used in this form of the disease, again scores one. Out of 14 drugs for bowel cancer, three score four but the rest all score less. For advanced breast cancer, Lapatinib scores five, but there are four drugs that score three or less, including Eribulin, which the National Institute for Health and Care Excellence (Nice) turned down but is paid for by the Cancer Drugs Fund. In melanoma (skin cancer), eight out of nine drugs score four.
It is a challenge to everybody involved in drug research, Sullivan said. “Are we really designing the trial that needs to be designed to prove clinical benefit or are we just trying to get [the drug] into the market? Is it genuinely for patients or to sell medicines?”
He and his colleagues hope the drug regulatory bodies will think about their decisions to approve the low benefit drugs. They also want the best drugs to get an approval rating that means they will be high priority for use in all countries.
Rolf Stahel, the Esmo president, said: “As the international organisation committed to the interest of the oncology community at large, we are concerned about some anti-cancer medicines approved by the European medicines agency not being available or affordable to patients when prescribed.
“We aim to signal the drugs with a large magnitude of clinical benefit which should be endorsed across Europe for rapid patient access, especially when these medicines are recommended through evidence-based standards set forth in the internationally recognised Esmo clinical practice guidelines.”