Cost of lead poisoning drug jumps from $3,500 to $32,000, making it hard for hospitals to stock

By CNN Newsource

Published December 6, 2023 3:10 AM

By Meg Tirrell, CNN

(CNN) — In August, the US Food and Drug Administration greenlit a new maker of an old drug used for the most severe cases of lead poisoning, ending a shortage and stopping the need for importation of the medicine from France.

The only problem: The new version costs almost 10 times as much as the imported version, about $32,000 per course of treatment.

“What we run up against with this pricing is that the hospitals are just not able to stock this drug,” said Dr. Diane Calello, executive and medical director of the New Jersey Poison Control Center.

And though it’s rare these days for a child in the US to have blood lead levels that are high enough to require this medicine, called calcium disodium edetate or EDTA, it does happen, she said; at that stage, they could have seizures, coma and brain swelling known as encephalopathy.

When a hospital doesn’t have the antidote in supply, “then we’ve got sometimes two or three days trying to find or source this drug,” Calello said. “Two or three days when you have a child who’s in a coma or having seizures or is really critically ill is intolerably long.”

It’s not the first time calcium disodium EDTA has been the subject of massive price hikes. In 2016, toxicologists flagged a 2,700% price increase on the medicine to Congress; Valeant Pharmaceuticals had acquired the maker of the drug in 2013 and increased the price from about $1,000 per course to almost $27,000.

It’s a playbook many associate with former pharmaceutical CEO Martin Shkreli, also known as the “pharma bro,” who in 2015 bought a decades-old medicine used to treat a parasitic infection that can afflict people with HIV and increased the price overnight by 5,000%.

But Valeant used the strategy on many more medicines until public and congressional pushback mounted. The company changed its name to Bausch Health in 2018.

After the price increases and resulting backlash, EDTA fell into shortage in 2021, and in October 2022, the FDA allowed importation of a version from France made by SERB’s BTG Pharmaceuticals to try to provide an option for US hospitals, a contingency put into place only when other options aren’t available. That version carried a wholesale acquisition cost of $3,500, a spokesman for the company told CNN.

Bausch discontinued its product. When a new company, Rising Pharmaceuticals, secured FDA approval for a US version of EDTA, it ended the ability to import the French one, although the company says the remainder of what’s already in the US can still be ordered.

The Rising drug has a wholesale acquisition cost of more than $32,000 per course of treatment, according to data shared by Erin Fox, a drug shortages expert and associate chief pharmacy officer at University of Utah Health.

That’s more than eight times higher than the imported French version’s price.

“We still have a long way to go to address the problem of high drug prices in the US,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and director of the Program on Regulations, Therapeutics and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.

Even after so much backlash about its previous price increase, the fact that EDTA now costs even more with a new maker shows “that the problem with high drug prices is not limited to specific manufacturers but is a more systematic issue with the approach we take that allows profit-driven decisions to put patients at risk,” he said.

Rising Pharmaceuticals didn’t respond to CNN’s requests for comment.

At EDTA’s new price, it could cost almost $50,000 to stock the recommended amount in a hospital, said Kait Brown, clinical managing director for America’s Poison Centers.

“The reality that we’re looking at is, we have hospitals that may be limited in resources to stock these antidotes,” Brown said.

EDTA is one of three main drugs used for what’s known as chelation therapy, when blood lead levels become very high – typically a threshold of more than 45 micrograms per deciliter, explained Dr. Kevin Osterhoudt, medical director of the Poison Control Center at Children’s Hospital of Philadelphia.

He describes lead like “a burglar who creeps undetected in children’s homes and robs them of their potential,” because even low levels are toxic to brain cells and nerves and can lead to lower IQ scores and cognitive deficits. Often, kids are exposed because of lead paint in homes, and their exposure can build up over time.

Most recently, kids have been exposed to lead in some cinnamon applesauce pouches, with reports of more than 60 potential cases among kids under 6. The FDA is investigating the source of the contamination, believed potentially to be cinnamon from a distributor in Ecuador.

Chelator drugs essentially grab on to lead particles and help remove them from the body. In addition to EDTA, which is given via IV infusion in the hospital, doctors turn to succimer, an oral capsule, and dimercaprol, or BAL, for chelation.

If blood lead levels are very high, perhaps over 70 micrograms per deciliter, a combination of succimer or dimercaprol with EDTA may be the best course, Osterhoudt said. If children have lead encephalopathy, or brain swelling, the best treatment is thought to be dimercaprol and EDTA.

Both those drugs currently can be hard to get, EDTA because of its new price and dimercaprol because its maker, Akorn Pharmaceuticals, filed for bankruptcy in February. According to the American Society of Health-System Pharmacists’ drug shortages database, there are no other makers. Succimer has also been in shortage over the years.

That tradeoff makes EDTA’s pricing situation more complicated, explained Dr.
Maryann Amirshahi, medical director for the National Capital Poison Center, who has studied drug shortages.

“The bigger problem that we need to look at is not just the price of this, because it is problematic, but at the same time, we don’t have the drugs that we need to treat this condition,” Amirshahi said. “I think it is unfortunate that there are going to be higher health-care costs, but at the same time, if there is a steady supply of a drug that we need to treat a critical, life-threatening condition, which is the lesser evil?”

Severe lead poisoning is a particularly difficult indication for drug companies because – in an example of a public health success story – it’s become increasingly rare.

“Over the past 50 years, we’ve lowered the lead levels down so low that we hardly ever use these drugs anymore,” said Dr. Alan Woolf, a professor of pediatrics and director of the environmental medicine program at Harvard Medical School. “I see kids with elevated lead levels all the time, but I rarely have to use these chelants on them.”

There were an average 2,188 reports of lead exposures to US poison centers each year between 2019 and 2022, and there have been 2,093 in 2023 through the end of November, according to data shared by America’s Poison Centers, which noted that those figures underestimate the true numbers as they’re voluntarily reported and include only cases where lead is the only substance involved.

The same data shows an average of 200 reports per year of uses of any of the three chelation drugs; for 2023 through November, there have been three reports of use of BAL, 21 of EDTA and 169 of succimer.

The relatively low usage of EDTA makes the market for medicines like this unappealing to drug companies, Utah Health’s Fox explained.

“We don’t have lots and lots of people getting poisoned all the time needing these antidotes, so it’s a really small market,” she said. “So it almost never makes sense to have multiple companies making antidotes.”

It’s a broader issue than just lead poisoning, said America’s Poison Center’s Brown.

“Unfortunately, it’s a common trend that we experience in toxicology specifically,” she said.

Still, Fox noted, Rising’s price of EDTA is “a great example of drug companies [being] able to price a product at whatever price they want, and it’s kind of whatever the market will bear.”

To Kesselheim, that suggests that the market is broken and that other solutions are needed.

“If the so-called ‘market’ for an off-patent drug for a rare disease breaks down to the point where no private manufacturer is able to produce it apart from at unsustainably high prices, that to me is a good rationale for investing in public-sponsored manufacturing so that patients can have access to the essential medications that they need,” he said.

He cited efforts like nonprofit manufacturer CivicaRx, which works with hospitals to provide access to generic drugs experiencing shortages or price hikes, as one example.

For now, hospitals may have to rely on one another to share supplies of rare stocks of chelation drugs. It’s a particularly problematic time not to have good access to them, the New Jersey Poison Center’s Calello said, as many kids spent more time at home during the Covid-19 pandemic, visited the doctor less and there was less access to support services like housing inspectors.

“It’s like the worst time ever to be a kid with lead poisoning,” Calello said. “And now, we’ve got a drug that we don’t have or that’s really expensive.”

For questions about lead exposure and poisoning, or if you need emergency assistance, call Poison Help at 1-800-222-1222 or visit PoisonHelp.org for additional resources.

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