Bloomberg News- Americans Are Paying Billions to Take Drugs That Don’t Work
Bloomberg news describes numerous cancer drugs and other treatments that FDA approved but were found to not work after companies made billions of dollars. Diana Zuckerman and Gregg Gonsalves explain that FDA approval used to take too long but the pendulum has swung too far so that expensive drugs that don't work and may be unsafe are costing patients and our healthcare system more than it can afford.
The post Bloomberg News- Americans Are Paying Billions to Take Drugs That Don’t Work appeared first on National Center for Health Research.
Bloomberg News
Americans Are Paying Billions to Take Drugs That Don’t Work
April 15, 2024
By Robert Langreth, Fiona Rutherford and Tanaz Meghjani
One ALS drug made $400 million in sales for its maker. It doesn’t work. A cancer treatment brought in $500
million. That one turned out to have no effect on survival. A blood cancer medication made nearly $850 million before being
withdrawn for two of its uses. That drug had been linked to patient deaths years prior.
million. That one turned out to have no effect on survival. A blood cancer medication made nearly $850 million before being
withdrawn for two of its uses. That drug had been linked to patient deaths years prior.
All of them were allowed to be sold to Americans because of the US Food and Drug Administration’s drive to get new drugs to
patients quickly — sometimes even before they’re done testing. The agency has been under pressure to move faster, a
dynamic that has roots in the AIDS crisis when patients were dying while waiting for new medications. But in the years since,
it has evolved into an approval process that critics say is driving confusion and could be putting people at risk.
patients quickly — sometimes even before they’re done testing. The agency has been under pressure to move faster, a
dynamic that has roots in the AIDS crisis when patients were dying while waiting for new medications. But in the years since,
it has evolved into an approval process that critics say is driving confusion and could be putting people at risk.
Drug companies are profiting, though. Since 2014, they’ve made at least $3.6 billion in global sales of medications that
have either later been shown to be ineffective or had most or all of their uses withdrawn in the US, according to data
compiled by Bloomberg.
have either later been shown to be ineffective or had most or all of their uses withdrawn in the US, according to data
compiled by Bloomberg.
“We get drugs faster and faster and know less and less about them and pay more and more,” says Yale University public
health professor Gregg Gonsalves, a former AIDS activist who was part of a group that urged the FDA to get quicker — but also
more rigorous — in the 1990s. Patient groups that are now pushing for speedy approvals took the wrong lessons from the HIV crisis, he said. “The idea is not to have more drugs. It is to have drugs that work.”
health professor Gregg Gonsalves, a former AIDS activist who was part of a group that urged the FDA to get quicker — but also
more rigorous — in the 1990s. Patient groups that are now pushing for speedy approvals took the wrong lessons from the HIV crisis, he said. “The idea is not to have more drugs. It is to have drugs that work.”
There are a number of ways a drug company can get its treatment to patients faster: There’s the “priority review”
pathway, then “fast track,” “accelerated approval” and “breakthrough therapy.” Companies can also use vouchers to
ensure speedier reviews for drugs that wouldn’t normally qualify. Bloomberg’s data analysis showed that the majority of
new drugs in the US are approved through one or more of these sped-up pathways. Last year two thirds of all new drugs reached
the market this way.
pathway, then “fast track,” “accelerated approval” and “breakthrough therapy.” Companies can also use vouchers to
ensure speedier reviews for drugs that wouldn’t normally qualify. Bloomberg’s data analysis showed that the majority of
new drugs in the US are approved through one or more of these sped-up pathways. Last year two thirds of all new drugs reached
the market this way.
[….]
Nearly a year and a half after the drug hit the market, a large study confirmed what skeptics had already suspected:
Amylyx’s drug was no better than a placebo. The company’s stock plummeted over 80%.
Amylyx’s drug was no better than a placebo. The company’s stock plummeted over 80%.
Amylyx is how taking its drug off the market — after reaping $400 million in sales from it.
Decades ago, the FDA reviewers weren’t very flexible and drugs sometimes languished for years as the agency demanded more
data.
Decades ago, the FDA reviewers weren’t very flexible and drugs sometimes languished for years as the agency demanded more
data.
“Now they’ve gone so far in the opposite extreme direction, sometimes approving things where there’s literally no evidence except wishful thinking,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank. The FDA’s Duvall-Jones said the agency only approves drugs if there is “substantial evidence” they work and the benefits outweigh the risks.
In theory, sped-up approval programs are designed for the most promising drugs that address some of the most crucial
medical needs. In practice, the drug industry has found ways to expand use of these pathways beyond the relatively narrow uses
for which they were originally envisioned. That may be because of pressure on the FDA from patients and their loved ones, who often join forces through nonprofits that make getting drugs approved quickly part of their mission.
medical needs. In practice, the drug industry has found ways to expand use of these pathways beyond the relatively narrow uses
for which they were originally envisioned. That may be because of pressure on the FDA from patients and their loved ones, who often join forces through nonprofits that make getting drugs approved quickly part of their mission.
The ALS Association, for example, said in its annual report that it “led a campaign to encourage the FDA to act with urgency and
flexibility” to get Amylyx’s drug to patients. After Amylyx’s drug failed in the larger study, the ALS Association put out a statement expressing disappointment and noting that they had supported the early approval because the drug appeared safe and patients were “willing to take the risk if it turned out to be ineffective.”
flexibility” to get Amylyx’s drug to patients. After Amylyx’s drug failed in the larger study, the ALS Association put out a statement expressing disappointment and noting that they had supported the early approval because the drug appeared safe and patients were “willing to take the risk if it turned out to be ineffective.”
Additional Approvals
One of the issues with the FDA letting a drug onto the market quickly is that it can open the door for similar drugs to
be approved, too. That’s what happened with a group of blood cancer drugs. Gilead Sciences Inc.’s Zydelig was approved in 2014 through
sped-up pathways for two types of lymphoma. But within two years, the company halted multiple studies of the drug due to
serious side effects and deaths of patients in trials. The FDA put out safety warnings, yet in the years after, the agency
continued to grant sped-up approvals for a number of similar drugs.
be approved, too. That’s what happened with a group of blood cancer drugs. Gilead Sciences Inc.’s Zydelig was approved in 2014 through
sped-up pathways for two types of lymphoma. But within two years, the company halted multiple studies of the drug due to
serious side effects and deaths of patients in trials. The FDA put out safety warnings, yet in the years after, the agency
continued to grant sped-up approvals for a number of similar drugs.
One of those was TG Therapeutics Inc.’s blood cancer pill Ukoniq, which snagged accelerated approval in February 2021 for
two types of lymphoma based on small trials that didn’t assess whether patients lived longer. The company’s shares shot up 12%
on the speedy approval.
two types of lymphoma based on small trials that didn’t assess whether patients lived longer. The company’s shares shot up 12%
on the speedy approval.
But less than a year later, a larger study of TG Therapeutics’s drug in a third blood cancer found a potential
increased risk of death when compared to patients on standard treatment.
increased risk of death when compared to patients on standard treatment.
[….]
One of the problems is that sometimes drugmakers resist pulling a drug off the market, even after it’s obvious it doesn’t work. Makena, a drug to reduce the risk of premature birth, received a sped-up approval in 2011. Eight years later, a large trial found it didn’t work.
Yet it took another four years for the FDA to force it off the market. Makena, which was owned by a number of companies in
its 12 years on the market, generated over $1.6 billion in sales.
its 12 years on the market, generated over $1.6 billion in sales.
The FDA is trying to take a stronger hand to get problematic drugs off the market. In February, it used a new
“expedited withdrawal” procedure for the first time to rescind the approval for Pepaxto, a bone marrow cancer drug from
Oncopeptides AB after the agency concluded that a new trial had failed to confirm the drug worked and actually suggested
patients taking the drug died sooner.
“expedited withdrawal” procedure for the first time to rescind the approval for Pepaxto, a bone marrow cancer drug from
Oncopeptides AB after the agency concluded that a new trial had failed to confirm the drug worked and actually suggested
patients taking the drug died sooner.
Oncopeptides’ shares, which hit a two-year high in Swedish trading shortly after the accelerated approval in February 2021,
have since lost more than 95% of their value.
have since lost more than 95% of their value.
[….]
A company can also use more than one sped-up pathway on the same drug in the hopes of getting to market that much faster.
In 2016, Eli Lilly & Co.’s cancer drug Lartruvo was approved after having snagged all four expedited pathways. The
accelerated approval was based on one trial of 133 patients that showed promising survival results in sarcoma, a cancer that
affects muscles and other soft tissues, even though the drug’s effect on slowing cancer growth weren’t clear cut.
In 2016, Eli Lilly & Co.’s cancer drug Lartruvo was approved after having snagged all four expedited pathways. The
accelerated approval was based on one trial of 133 patients that showed promising survival results in sarcoma, a cancer that
affects muscles and other soft tissues, even though the drug’s effect on slowing cancer growth weren’t clear cut.
Just over two years later, a larger study showed the drug had no effect on patient survival and Lilly pulled it from the
market. …. In the short time Lilly’s drug was available, it sold more than $500 million.To read the entire article, click here
https://blinks.bloomberg.com/
market. …. In the short time Lilly’s drug was available, it sold more than $500 million.To read the entire article, click here
https://blinks.bloomberg.com/
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