Most expedited cancer drugs don’t pan out, research finds
According to research published Sunday, most of the cancer drugs granted faster approval by the FDA do not show positive results within five years.
The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives?
In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years.
“Five years after the initial accelerated approval, you should have a definitive answer,” said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.”
The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs.
It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval.
Patients get access to drugs earlier, but the tradeoff means some of the medications don’t pan out. It’s up to the FDA or the drugmaker to withdraw disappointing drugs, and sometimes the FDA has decided that less definitive evidence is good enough for a full approval.
The new study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approval. Of those, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials.
The research was published in the Journal of the American Medical Association and discussed Sunday at the American Association for Cancer Research annual meeting in San Diego.
It’s unclear how much cancer patients understand about drugs with accelerated approval, said study co-author Dr. Edward Cliff of Harvard Medical School.
“We raise the question: Is that uncertainty being conveyed to patients?” Cliff said.
Drugs that got accelerated approval may be the only option for patients with rare or advanced cancers, said Dr. Jennifer Litton of MD Anderson Cancer Center in Houston who was not involved in the study.
It’s important for doctors to carefully explain the evidence, Litton said.
“It might be shrinking of tumor. It might be how long the tumor stays stable,” Litton said. “You can provide the data you have, but you shouldn’t overpromise.”
Congress recently updated the program, giving the FDA more authority and streamlining the process for withdrawing drugs when pharmaceutical companies don’t meet their commitments.
FDA spokesperson Cherie Duvall-Jones wrote in an email that the FDA can now require that a confirmatory trial be underway when it grants preliminary approval, which speeds up the process of verifying whether a drug works.
Renowned for ancient churches and the tomb of Dante, the 14th-century poet, the city of Ravenna and its environs along Italy’s Adriatic coast are also home to old-line industries like steel and fertilizer. The manufacturing plants are of little interest to the many tourists who help sustain the area’s economy, but these sites employ tens of thousands of people.
The question is: For how long? The factories, like others in Europe, face increasing pressure from regulators to reduce the climate-altering gases that their operations produce. The worry is that rising costs from regulation will force them to close.
“We are very scared about the future of our industries,” Ravenna Mayor Michele De Pascale said. “We have to reach this goal to reduce CO2 emissions, but we want to do it without destroying our industries.”
Italy’s energy giant, Eni, which has a large presence in Ravenna, is pushing a plan that the mayor says could help preserve the region’s heavy industries: create an industrial pollution collector.
The company is proposing to construct a network of pipelines to sweep up the carbon dioxide from the sites and store it away in old natural gas reservoirs. It sees this process, known as carbon capture and storage, as a promising new business line that would aid its shift to cleaner activities.
Eni is working on similar plans elsewhere in Europe, notably in Britain, where many mature oil and gas fields offer large volumes of storage potential.
There are other carbon capture projects around the world, including in the United States, often aimed at reducing emissions from oil and natural gas
Eni’s gas processor is seen March 13 in Casalborsetti, Italy. MAURIZIO FIORINO/THE NEW YORK TIMES production.
The company wants to diversify away from the oil and gas sales that have long been its mainstay, but it faces an uncertain future because of climate change concerns. Eni executives calculate they will have an edge because they can make use of the company’s existing infrastructure, like wells and pipelines, and redeploy employees.
“It is very easy to reskill or shift people,” Eni CEO Claudio Descalzi said.
Descalzi plans to turn carbon capture into a “satellite” company that could attract other investors seeking profits that he forecasts could be about 10% a year.
The transition to cleaner energy will succeed only if it spawns sustainable businesses, Descalzi said. “Otherwise, it will fail,” he added. “Because resources are limited and you can’t burn money.”
Eni has about 50 operating petroleum platforms in the Adriatic Sea off Ravenna, beyond lagoons dotted with flamingos. With production falling, Eni plans to pump carbon dioxide into the depleted gas reservoirs, which will act as giant sponges for the