This article is part of the Global Policy Lab: Decoding Cancer.
Researchers want to save the pharmaceutical industry time and money on clinical trials. But that means teaching companies to work together and convincing them to pool patient data, benefiting not just themselves but also their competitors.
Its not an easy sell.
“In the vast majority of cases, the company wants to be in control,” said Denis Lacombe, chief of the European Organisation for Research and Treatment of Cancer.
Lacombe is basically in a race against Big Pharma to build a public biological database before companies create their own private ones.
The stakes, for patients, are high.
Innovations in so-called precision medicine, in which treatments are tailored to individuals, has made patient data critically important. The more it is walled off in corporate troves, some cancer experts like Lacombe warn, the more the potential of using big data is undermined and the harder it becomes for patients to find relevant experimental treatments.
EORTCs SPECTA platform is a collection of genomic and other biological and clinical data. When a new treatment is available to be tested, the data can be searched to identify patients who could participate.
Thats something that will be increasingly important as personalized medicine drives pharmaceutical companies “to search for specific patients with specific [genetic] alterations,” Lacombe said.
That should be an opportunity for the pharma industry, said Lacombe. But it hasnt worked out that way.
The industrys been slow to engage with SPECTA. Lacombe is concerned that instead, companies are starting to collect peoples genomic data on their own, without having a particular treatment or trial in mind.
“There is a risk that the commercial sector will develop a … parallel route to access DNA,” he said. Its “suboptimal, if not unethical, that companies collect biological data and put it in a commercial silo.”
The EORTC isnt the only one trying to collect patient data.
A parallel effort with a more utopian vision is based in the neutral Alpine haven of Switzerland. MIDATA cites the philosopher John Rawls and his idea of “Property-Owning Democracy” in its promotional material. Its founder, Ernst Hafen, predicts that it could make even more money than Google or Facebook — though it would all be reinvested for the good of society.
People who contribute personal information to MIDATA — whether its their genome or smartphone steps log — would remain the owners of their personal info and get to sign off on how its used. Theyd also become shareholders in MIDATA, able to vote on how it conducts business and spends its profits — earned in part by pharma companies who pay to recruit study participants.
MIDATA is starting slowly, with some academic partnerships and some companies interested in how patients are faring with their migraine and multiple sclerosis drugs. But Hafen insists that MIDATA is the future, “a citizen-empowered way of changing the way science is done.”
If patient data is to be collected in public data bases, citizens might have to do the powering. But there are signs the industry is slowly coming around.
Signs point to the pharma industry increasingly being open to sharing data and cooperating on trials, but theyre not eager to talk about it publicly yet. Requests for comment from both the European Federation of Pharmaceutical Industries, the sectors Brussels lobby, and individual companies yielded no one willing to discuss these new initiatives.
Collaboration has never been the pharmaceutical industrys strong suit. While industries like aviation and semiconductors have been working together for decades, “the pharmaceutical industry has been lagging,” said Dalvir Gill, CEO of TransCelerate BioPharma, a non-profit initiative trying to change that.
Over the past seven years, TransCelerate has looked for ways to coordinate clinical trials. They have created a common set of forms for different companies trials. It also created a network for companies to procure comparable drugs from each other directly for use in trials, rather than having to buy the longer-standing treatment from third parties to test against a new drug.
Ten companies signed on to TransCelerate initially, up to 19 now. Its required companies to change their mindset, Gill said.
Theres a “vast amount of work that happens in the development of drugs that is not competitive,” Gill said. “The R&D people get it,” he added, but in the commercial divisions of a company, “theres a lot more convincing that needs to happen there.”
Regulators also need convincing, Gill noted — when companies cooperate, it raises a different set of eyebrows.
“Our biggest barriers are typically not running afoul of antitrust,” Gill said. “Whenever you have 19 companies in a room doing something,” its going to draw scrutiny.
With lots of new cancer drugs coming out for increasingly narrow subsets of cancer patients, so-called platform trials — in which multiple new drugs are tested at once — are seen as a key way to speed up the process and avoid duplication.
But companies are deeply resistant to the idea of having their new idea compared (possibly unfavorably) to someone elses.
The I-SPY 2 trial for breast cancer, non-profit platform trial that has resulted in three drugs winning approval, showed drugs can be tested at the same time without being pitted against each other. Instead theyre tested against the existing standard of care.
Brian Alexander, a Harvard radiation oncologist preparing to launch a platform trial for brain tumors called GBM AGILE, said that the precedent has made it easier for him to convince companies to let him test their drugs.
“They werent as worried anymore because once you see two New England Journal [of Medicine] papers in the same edition, both coming from arms from I-SPY 2, and theyre not compar[ed to] each other… then [drugmakers] were like, Oh, ok, that isnt that much of an issue,” Alexander said.
Hes expecting to announce the first drug to be tested in the new GBM AGILE trial next week, but he said that overcoming companies fear of sacrificing control remained a major challenge.
“To feel like theyre turning over the late stage development of an asset to this other entity — thats a bit of a tough sell,” Alexander said.
Flu vaccine delays for over-65s ‘resolved by weekend’
GPs and patients frustrated by a shortage of the new flu vaccine for over-65s are being told the fin..
GPs and patients frustrated by a shortage of the new flu vaccine for over-65s are being told the final delivery batch will arrive by Saturday.
NHS England said there would be enough vaccines for everyone to be protected ahead of winter.
But doctors' leaders said more guidance should have been given to GPs and patients to avoid disruption over the phased delivery of supplies.
Older adults are advised to get the flu jab by early December.
This gives time for protection before flu starts to circulate, normally later in the month.
However, the staggered delivery of supplies of the over-65s vaccine from the manufacturer Seqirus to GPs and pharmacies means some older patients have not been able to be vaccinated.
In a survey of 650 GPs in Pulse, nearly 70% said there had been a shortage of this flu vaccine at their practice.
That meant they could not vaccinate as many elderly patients as they would have liked.
Some GPs said they had to cancel appointments while others said it had created staffing problems.
But a spokesperson for NHS England said that this week, "100% of vaccines will have been delivered by the manufacturer to those surgeries and pharmacists who placed an order on time". (more…)
NHS bosses look to overhaul cancer screening
Cancer screening programmes are to be reviewed following high-profile mistakes that have put thousan..
Cancer screening programmes are to be reviewed following high-profile mistakes that have put thousands of patients in England at risk.
NHS England has asked former government cancer tsar Sir Mike Richards to look at what changes are needed.
Three national schemes cover breast, cervical and bowel cancers.
On Wednesday, it emerged letters about the cervical cancer tests that should have gone to 40,000 women between January and June had not been sent.
About 4,000 of them were results of tests, the remainder were letters inviting them for screening or reminding them tests were due.
Between 150 and 200 of the test results that were not sent out detailed abnormal results.
NHS bosses have been able to contact all those affected.
The service in charge of distributing letters is provided for NHS England by Capita.
Looking at the merits of outsourcing screening was going to form part of the review, NHS England said.
The problems come just months after it emerged 174,000 women had not been invited for breast cancer screening, after mistakes had gone undetected for years. (more…)
Superbug risks fail to dent attitudes to antibiotics
Warnings about drug-resistant superbugs arent enough to change most peoples behavior on using antibi..
Warnings about drug-resistant superbugs arent enough to change most peoples behavior on using antibiotics, according to a Europe-wide poll out Thursday.
The Eurobarometer survey reported seven in 10 people who received information telling them not to take antibiotics unnecessarily said it didnt change their views on using them.
Excess use of the drugs is contributing to a growing threat of antimicrobial resistance and related infections. As germs multiply they can develop the ability to defeat the medicines designed to kill them — and those infections could be killing more than 33,000 people a year in Europe, according to recent estimates.
“It is ridiculous,” European Health Commissioner Vytenis Andriukaitis said in response to the fact that people arent responding to warnings, at an event in Brussels Thursday. “We have science on one hand and lack of trust on the other.”
“Unless we act decisively, immediately and together, we could face a public health and financial disaster,” he added.
The EU is failing to gain traction with its effort to get member countries to combat the rise of resistance.
The Eurobarometer survey showed the number of people who had taken antibiotics in the last 12 months fell from 40 percent in 2009 to 32 percent in 2017. But less than half of people said they were aware that antibiotics dont work to treat viruses, and 20 percent said they take antibiotics to treat flu or colds.
Seven percent of people said they took antibiotics without having seen a doctor or getting a prescription.
Andriukaitis said the survey, which polled around 27,400 people in 28 countries, shows Europeans “are still not sufficiently aware of the dangers of AMR.”
A report from the European Centre for Disease Prevention and Control (ECDC) on Thursday raised particular concern about the rise of superbugs in hospitals and care centers — estimating there are around 8.9 million cases of health care-associated infections in European facilities each year, many of them caused by multidrug-resistant bacteria. (more…)
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