The huge increase in the price of a lifesaving lead poisoning treatment has prompted a Michigan lawmaker to call for a congressional investigation into Valeant Pharmaceuticals.

Two years ago, the drug maker boosted the list price for Calcium EDTA by roughly 2,700 percent. After Valeant bought the drug in 2013 as part of a deal in which it took over another company, the list price for a package of vials started rising quickly. After being stable at $950, Valeant raised the price several times before closing out 2014 at more than $26,900.

“It’s a pretty grotesque example of corporate greed to see this kind of price increase,” US Representative Dan Kildee, (D-Mich.), who hopes to convince a Congressional committee to hold a hearing, told us. “We’ve seen such increases elsewhere, but that doesn’t justify it for a drug that, in most cases, is very likely to be used for a child who lives in poverty and exposed to high levels of lead ingestion. That makes it pretty egregious.”

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The price hikes have angered toxicologists, who note the drug is decades old and that other companies sell the same medicine for much lower prices in other countries. Ever since the price hikes began two years ago, poison-control specialists and physicians have been complaining, but until now, their efforts — which included reaching out to Washington lawmakers — did not gain traction.

As we noted previously, doctors acknowledge there are relatively few cases of severe lead poisoning each year, which means that only a small number of packages are stocked. There were about 50 serious cases reported in 2015, according to the American Association of Poison Control Centers, which also contacted Congress earlier this year about the increased pricing.

But even this small outlay can take a toll on hospital finances, and by extension public health, according to emergency room experts. In part, this is because the shelf life for the treatment is limited, but also because the funds could be used for other purposes, which can be an issue especially for some inner city hospitals that have limited resources and are more likely to see cases of lead poisoning.

The pricing further frustrates toxicologists because there are few viable alternatives. Most hospitals are not equipped to compound their own versions of the intravenous medicine. A pill called DMSA can be used, but since people suffering from severe lead poisoning are unconscious or can have seizures, it must be administered through a nasal tube into the stomach, which creates a risk of lung-related complications.

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Valeant has explained the current pricing is justified in order to maintain consistent supplies, and that there are high carrying costs, since about 200 to 300 units are sold each year. Each unit contains a pack of five vials. The company also must purchase sufficient supplies of needed ingredients in advance and this can amount to three to five times more than recent annual sales, which were between $3 million and $5 million last year. The list price also does not reflect any rebates or discounts that Valeant pays.

Kildee, by the way, represents a part of Michigan that includes Flint, where lead in the water has become a huge public health problem. However, he noted that, while exposures were very high, residents were exposed over a period of time, which would have precluded emergency treatment with the drug. “So the opportunities to be treated (with the Valeant drug) were made more difficult as a result,” he explained.

“But this isn’t just about Flint kids,” he continued. “This is about any child or person exposed to high levels of lead and about a kind of corporate greed that, if left unchecked, can just continue.”

[UPDATE: Valeant later issued a statement noting that it “does not sell a product that can treat chronic asymptomatic exposure to lead.”  Also, Dr. Michael Kosnett, an associate clinical professor in the division of clinical pharmacology and toxicology at the University of Colorado’s School of Medicine and a consultant to the California Poison Control System, whose complaints about pricing were previously reported, has noted the drug would not be used for situations such as the Flint water crisis because concentrations of lead would not likely have been high enough.]

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  • @Silverman I think you’re being disingenuous. You’re diverting attention away from who is really responsible for Flint’s contaminated water supply, the government in the area that either failed to control pollution of the water source or the water providing utility that failed to adequately filter the water.

    Your article is directly demonizing Valeant, when it has nothing to do with Valeant. I don’t see how you can come off calling them greedy when you don’t even try to report their side, so I’m doing it for you. Figure it out, 100 doses a year for a drug with a limited shelf life is going to increase costs per dose astronomically irrespective of who produces the drug…it’s called the free market and market pricing. This is a generic drug, anybody can produce it. any hospital can compound it. So why don’t they instead of buying it from Valeant..maybe because it would cost them more for an inferior product??

    • Dear Mr. Flint,

      I did not call Valeant a ‘greedy’ company. I reported that a Congressman called the company ‘greedy.’ Those are two different things, as I would hope you can appreciate.

      And I did report the company’s side of the story after speaking with Valeant to ask for a response to the concerns raised by the physicians and poison control association.

      Again, the information about the costs, the limited shelf life and the number of units sold was noted, as it was in our first story, which appeared on Oct. 11. A link to that story is in the second paragraph of this story.

      As far as compounding, the first story provides a little added perspective about compounding considerations, from the perspective of the physicians I spoke with – who are also poison control specialists.

      Valeant’s position may well make financial sense. At the same time, the concern over the pricing – as expressed by the toxicologists and the poison control centers – may also be justified. I reported both sides.

      Thanks for stopping by,
      ed

  • Recent statements have falsely asserted that Valeant sells a “leading treatment” for children poisoned by lead in Flint, Michigan.

    Calcium Disodium Versenate (CDV) is a sterile, injectable formulation of Calcium EDTA that is used to treat acute cases of lead poisoning and lead encephalopathy. Contrary to recent statements and media reports linking this product to the Flint water crisis, CDV is not used to treat elevated levels of lead in the blood that result from the chronic low-level lead exposure like that reportedly experienced in Flint, Michigan.

    As reported in the Detroit News on October 21, 2016: “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.”

    While Valeant does not sell a product that can treat chronic asymptomatic exposure to lead, our thoughts are with the people of Flint who have been adversely affected by the wide-scale mismanagement that led to the water crisis. We have been in touch with Congressman Kildee’s office to correct any misunderstanding about the clinical efficacy of our product and have offered our assistance should there be a patient with acute symptomatic lead poising who requires CDV.

    With respect to concerns about the list price of CDV, past price actions enabled the provision of consistent supply of a product with high carrying costs and very limited purchase volume of 200-300 units per year. 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. The company does not generate material revenue from this product, which represents less than 0.01% of our total revenue.

    • Dear Mr. ‘Flint,’

      Thanks for your note. Yes, as noted in this story, by the Congressman, the Valeant drug would not have been used for the water problems in Flint. And toxicologists have told me that the medication would not be suitable, generally, because the levels of lead poisoning would probably not be the same as in cases of involving paint chips, for instance.

      The story did not suggest otherwise. Nor did the Congressman. He is addressing the pricing – right or wrong – because he claims to be concerned about the larger issue of treating lead poisoning, however it may occur.

      By linking his position as a Congressman who represents the Flint district to his objections to the cost of the drug, Valeant supporters would appear to be trying to create the impression that he is making incorrect assertions.

      Also, the company’s explanations for the pricing, including its costs and the volume of units sold each year, were noted here and in our previous story, which can be read by clicking on the link in the second paragraph of this story.

      Hope this helps,
      ed

    • Dear Mr. Alpert,

      Thanks for your note. There is nothing in the story that suggests this drug would or could have been used to deal with the water problems in Flint. That is noted near the end of the story, in fact.

      As I wrote in this story and the previous story – a link appears to the earlier story in the second paragraph – toxicologists are concerned about the price. The issue in Flint is not the issue raised by the physicians or the American Association of Poison Control Centers.

      The congressman from Michigan is addressing the pricing – right or wrong – because he claims to be concerned about the larger issue of treating lead poisoning, however it may occur.

      Hope this helps,
      ed

  • Embarrassing for the media and politicians talk about something they dont know , the Flint case cant be treated with Valeant medicine, prescribe only for acute cases, not chronic cases as Flint. Media and politicians should get better educated before create rumors, you hurt investors who are already negative, because so much non sense noise.

    • Dear Mr. Staack,

      Thanks for your note. There is nothing in the story that suggests this drug would or could have been used to deal with the water problems in Flint. That is noted near the end of the story, in fact.

      As I wrote in this story and the previous story – a link appears to the earlier story in the second paragraph – toxicologists are concerned about the price. The issue in Flint is not the issue raised by the physicians or the American Association of Poison Control Centers.

      The congressman from Michigan is addressing the pricing – right or wrong – because he claims to be concerned about the larger issue of treating lead poisoning, however it may occur.

      Hope this helps,
      ed

  • Corporate greed at its best. Valiant does not even have the R&D costs to hide behind because the drug was developed in another company’s pipeline.

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