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Shortage Of Child Cancer Drug Reveals Broken US Health Care System

Pfizer and Israeli company Teva were the only manufacturers of Vincristine until July 2019, when Teva made a "business decision" to stop producing the drug, leaving Pfizer as the sole U.S. producer.
Pfizer and Israeli company Teva were the only manufacturers of Vincristine until July 2019, when Teva made a "business decision" to stop producing the drug, leaving Pfizer as the sole U.S. producer. (Photo: John R. Perry, Pixabay)

“The average price of vincristine in the developing world, where it is on the World Health Organization’s list of essential medicines, is $1.80 a dose, compared to $42.60 per dose in the U.S.”

Vincristine, a vital chemotherapy drug used to treat childhood cancer, is being rationed because it is insufficiently profitable, according to a report published by the Food and Drug Administration last Tuesday. While the FDA believes hospitals should pay more for the low-cost generic to incentivize its production, critics argue catering to the whims of Big Pharma shouldn’t be the central concern in producing a life-saving drug for kids with cancer.

The American Prospect’s Robert Kuttner argues the true reason for the shortage is the overwhelming power of drug corporations and the refusal of regulators to confront them. Kuttner explains how like insulin, there is no explanation for the drug’s shortage:

“Vincristine is a well-established drug. The introduction of chemotherapy agents like vincristine turned childhood cancers from a death sentence to a category of cancer with a high cure rate.

“It was first developed in 1961, and has long been a generic. That means it should be cheap and plentiful, like aspirin. Indeed, the average price of vincristine in the developing world, where it is on the World Health Organization’s list of essential medicines, is $1.80 a dose, compared to $42.60 per dose in the U.S.”

Pfizer and Israeli company Teva were the only manufacturers of Vincristine until July 2019, when Teva made a “business decision” to cease production of the drug, leaving Pfizer as the sole U.S. producer. “According to Dr. Sidney Wolfe, who founded the Public Citizen Health Research Group, in situations like this the dominant producer then keeps the supply relatively scarce in order to keep the price high, and sometimes cuts its strategy too close, creating shortages,” writes Kuttner.

Pfizer and Teva, which have been scrutinized for criminal price-fixing, aren’t the only culprits. Kuttner explains how group purchasing organizations, or GPOs, serve as non-transparent middlemen that buy drugs like vincristine in bulk for hospital networks and “pull huge fees out of the cost of the supplies.”

The FDA report did not consider government involvement as a potential solution to the problem, concluding that shortages will likely continue as an inevitable consequence of the “broken marketplace.” Critics were unsatisfied with this conclusion, arguing that public funds should be able to help cancer patients if they could be used to rescue Wall Street after it crashed the economy with subprime mortgages in 2008.

“The government has previously stepped into the marketplace to assist the ailing automotive industry, Wall Street and the insurance companies,” Dr. Yoram Unguru, who treats children with cancer at the Herman and Walter Samuelson Children’s Hospital at Sinai in Baltimore, told the New York Times.

“Why not do the same for our ailing health care system, specifically the manner in which lifesaving medications are manufactured and distributed?” Dr. Unguru believes that life saving medications should be viewed as “critical infrastructure, not unlike public utilities such as electricity and water,” and called preventable drug shortages “unacceptable and ethically unjustifiable.”

Big Pharma Owns Congress And FDA

Kuttner argues it is absurd that the FDA treats drug shortages as “if they were some kind of naturally occurring calamity,” noting the agency’s close relationship with the drug industry may have something to do with its policy prescriptions.

Nine out of the last ten FDA commissioners joined the pharmaceutical industry after their public service. Scott Gottlieb, for example, was Trump’s FDA commissioner until March before joining Pfizer’s board of directors in June. As the New York Times reported in 2012, the industry bias is so extreme that the FDA even conducted a “wide-ranging surveillance operation” on its own scientists to suppress unfavorable drug safety opinions.

Dr. Raeford Brown, a pediatric anesthesia specialist at the UK Kentucky Children’s Hospital and chair of the FDA Committee on Analgesics and Anesthetics, says the government’s deference to the drug industry goes beyond the agency, “because Congress is owned by pharma.”

“The pharmaceutical industry pours millions of dollars into the legislative branch every single year,” he told Yahoo Finance. “In 2016, they put $100 million into the elections. That’s a ton of money.”

Kuttner argues that in previous eras, Congress would have held immediate oversight hearings with the executives of Pfizer and Teva upon news of the vincristine shortage.

“I’m really much more concerned because Congress is supposed to have oversight for the FDA,” Dr. Raeford Brown said. “If the FDA isn’t going to hold pharma accountable, and Congress is getting paid to not hold pharma accountable, then it really doesn’t matter who the president is because it’s really about Congress.”

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Peter Castagno

Peter Castagno is a staff writer and assistant editor at Citizen Truth.

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