Lead drug price hike hits nerve in Flint

Karen Bouffard, and Melissa Nann Burke

Correction: This story has been updated to correct the name of the drug calcium EDTA and the spelling of Marianne Udow-Phillips' name.

The cost of a lead poisoning drug that’s a staple in hospital emergency departments has increased by roughly 2,700 percent since 2013, resonating with some in Flint and prompting a call for a congressional hearing.

Quebec-based Valeant Pharmaceutical increased the list price of calcium disodium versenate, a sterile injectible version of the drug calcium EDTA, to $27,000 for a five-day course after acquiring the Medicis drug company in 2013. Medicis had charged $950 for the same five-day treatment.

It’s among a number of price hikes for drugs most often needed in low-income communities where problems such as lead poisoning and asthma are prevalent.

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Outrage recently soared over the cost of the EpiPen, which is carried to school by children with asthma or severe allergies and injects a life-saving dose of epinephrine. It was put out of the reach of many families earlier this year when its manufacturer, Mylan, raised the price from $100 to $600 for a two-pack. Mylan since has announced it will come out with a less expensive version.

News of Valeant’s price hike angered U.S. Rep. Dan Kildee, who called it “the worst example of corporate greed taking advantage of poor people.”

“Because of the sensitivity we have to issues related to lead poisoning it obviously got our attention,” the Flint Township Democrat said Thursday.

While the drug hasn’t been needed in Flint because it’s not made for the kind of lead poisoning suffered there, its price still hit a nerve.

“The idea that Valeant would charge these insane numbers for treatment is just unconscionable,” Kildee said.

A Valeant spokesman said Thursday its Calcium Disodium Versenate is priced high because it’s so rarely required, even by hospitals and poison control centers.

“The list price increases of CDV have enabled us to provide consistent availability of a product with high carrying costs and very limited purchase volume of 200-300 units per year,” the company told The News in a Thursday email. “The list price of CDV does not reflect the actual cost of the product to hospitals that purchase it, after rebates and other adjustments.

“Because CDV has a relatively limited shelf life and the minimum CDV purchase requirement for Valeant is roughly 3-5 times higher than recent annual sales volume, we have written down at our own expense approximately half of purchased quantities in the past few years.”

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Issues to explore

Kildee called for congressional hearings after the Nov. 8 election into what he described as “price gouging” by pharmaceutical companies.

“(Drugs) are offered at a relatively reasonable price, and then because they have the ability, because of the unique nature of the drug, this kind of price gauging, occurs and it’s just the worst example of corporate greed,” Kildee said. “They’re taking advantage particularly of poor people, because ... the likelihood of lead exposure in children is predominantly for people who are poor.

“Our focus right now is getting to the bottom of this, getting all the facts.”

Among the issues for Congress to explore, Kildee said, is the availability of possible alternative medications. San Diego-based Imprimis Pharmaceuticals this week introduced five-day, $495 compounded alternative that uses the same chemicals as the Valeant product, but it’s unlikely to replace the Valeant medicine under current Food and Drug Administration policies.

Compounds are mixtures of medicines combined by doctors or licensed pharmacists to meet individual needs of patients.

Under FDA rules, certain compounders may offer their compounded drugs only in response to prescription for a specific patient. Imprimis argues this situation makes its product useless for hospitals that wish to stock the medicine for emergencies.

Under FDA rules, a compounded drug can only be produced in response to a doctor’s prescription, one dose at a time. This makes the Imprimis product useless for hospitals that need to stock the medicine for emergencies.

“In the modern regulatory environment, prescribing a compounded medication comprised of one or more FDA-approved drugs is equivalent to prescribing an FDA-approved drug for ‘off-label’ use — that is, for an application not specifically approved by the FDA,” Imprimis founder and CEO Mark Baum said Thursday.

“Off-label use of FDA-approved medications, like drug compounding, is commonplace. Physicians routinely prescribe compounded medications or drugs for off-label uses because they believe them to be the best medical options for their patients.”

Baum said he would welcome a congressional investigation.

“What we really need is sane, rational policy that helps people,” Baum added.“We’re talking about old, old, drugs that should be really inexpensive, and yet the prices continue to go up and up and up.

“I’m calling on (drug developers and manufacturers) to work with us and with members of Congress to come up with a new policy so we can bring affordable solutions to people.”

A matter of approval

The FDA stresses that drugs made by compounders are not approved by the agency and, therefore, have not undergone the same pre-market review for safety, effectiveness and manufacturing quality.

When an FDA-approved drug is available, the federal agency says it should be prescribed over a compounded drug, unless the prescriber determines that a particular patient needs a compounded product.

Elizabeth Jungman, director of public health programs at the Pew Charitable Trusts, cautions that a new formulation or ingredient combination can make a drug less effective or safe.

“This drug pricing issue is a serious issue, but the way to solve that problem is not to ask patients to accept potentially substandard products by turning to compounding,” Jungman said.

“When you’re substituting unproven compounded versions of products — and they could be made under quality conditions — the real issue is that you’re exposing patients to unknown risk and undermining the incentive for pharmaceutical companies to do the testing that’s necessarily to protect patients.”

Congress updated the law regulating compounding manufacturers in 2013, following the outbreak of the deadly fungal meningitis that led to 64 deaths and was traced to a Massachusetts compounding pharmacy.

Flint pediatrician Dr. Mona Hanna-Attisha, who sounded the alarm over the city’s lead problem, said Calcium Disodium Versenate is not an appropriate treatment for children like those in Flint who were exposed to low levels of lead in their drinking water over a long period of time.

The Valeant drug is for people exposed to high levels of lead, and for them it can be life-saving, Hanna-Attisha said.

“It’s a chelating agent for very high lead levels,” said Hanna-Attisha, referring to a class of drugs that remove metals from the body. “There is no treatment for lead. Treatment is prevention.

“Chelating agents don’t even change neurocognitive impacts but (are) life saving at super, super high levels. The access and affordability of this med is an issue in other places.”

Wherever the drug is used, the price tag is a problem, whatever the reason, said Marianne Udow-Phillips, director of the Center for Healthcare Research and Transformation at the University of Michigan.

“There’s little question that this particular drug is a critical drug even if it’s used only occasionally, so it’s very important that they make it affordable for people,” she said.

“It’s got to be a congressional discussion, and I’m hoping that after the election they will look at this issue.”