Drug Shortages Are Speeding Cancer Deaths, Survey Says

ASCO President Calls for Reimbursement Reform

Nick Mulcahy

February 02, 2012

February 2, 2012 — Cancer drug shortages hastened the deaths of some patients in 2011, according to a small survey of American clinicians, conducted by a for-profit research firm with ties to drug companies, that was released this week.

This dire news comes the same week that the Drug Shortage Prevention Act was introduced in the US House of Representatives by John Carney (D-Delaware) and Larry Bucshon (R-Indiana).

The legislative action is too late for some patients, the survey results suggest.

The survey involved 206 clinicians, nearly all of whom (99%) were board-certified in medical oncology or hematology/oncology.

In a section of the survey that asked about a clinician's experience in the previous year, 40% (n = 82) indicated that "a patient died sooner due to drug shortages." The majority of these respondents said that such an event was infrequent and happened only "a few times" in the previous year.

Conversely, 60% of respondents said that the shortages did not hasten any patient deaths.

Physician members of the Epocrates Web panel were paid $80 to complete the questionnaire. The firm that conducted the survey has worked for the pharmaceutical industry in the past, but funded this research itself.

Because the survey did not reveal the identities of the participants and the reports of deaths were not documented, there is no way to verify the findings.

However, 2 experts who wrote an essay last year in the New England Journal of Medicine suggested that the chronic shortage of cancer drugs would eventually cause a patient death (N Engl J Med. 2011;365:1653-1655).

As reported by Medscape Medical News, Mary Gatesman, PharmD, from the Virginia Commonwealth University Health System in Richmond, and Thomas Smith, MD, from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland, said that they were "unaware of any documented death of a patient with cancer," but warned that "it is only a matter of time."

In another development this week, Michael P. Link, MD, president of the American Society of Clinical Oncology (ASCO), said that economics are driving the problem.

"There are numerous causes for the escalating drug shortage crisis, but in our view, none are as powerful as simple economics," write Dr. Link and 2 coauthors in an essay published online January 30 in the Journal of Clinical Oncology.

"The most straightforward solution is to change the way generic sterile injectables are reimbursed," they say.

Dr. Link and coauthors explain that "if the generic drug price is kept at 5% to 10% of the brand drug price, and/or the ASP [average sales price] plus 6% reimbursement is modified to an ASP plus 10% to 20%, the profit margin will remain reasonable, and generic drug companies will have adequate incentive to continue to supply the drug."

Is Congressional Action on the Money?

The survey participants were oncologists who have been in practice 6 to 30 years and see at least 50 cancer patients per month, explained one of the researchers, Susan Schwartz McDonald, in an email to Medscape Medical News. She is president of National Analysts Worldwide, the company that conducted the survey.

It is projected that drug shortages will continue to hasten the deaths of cancer patients in the coming year, according to the survey. Half (50%) of the respondents expect to see more hastened cancer deaths; few (14%) anticipate a reversal of the trend.

There are other health consequences of the cancer drug shortage.

About half of the respondents (48%) said they believe that some tumor recurrences occurred due to drug shortages in the previous year.

"There has been much concern about drug shortages, but these findings confirm some of our worst fears," said McDonald, referring to the deaths and tumor recurrences, in a press statement.

The drug shortage problem in the United States has escalated to crisis levels, as reported by Medscape Medical News. The number of affected drugs continues to climb, according to the offices of Reps. Carney and Bucshon. In 2005, there were 61 different drug shortages; in 2010, there were 178, and in 2011, there were 230.

The shortages affect several therapeutic fields, but oncology has been hardest hit, as reported by Medscape Medical News.

ASCO reacted immediately to the news that 2 members of Congress introduced a bill to attempt to address the problem. "Last year, the medical community experienced a record number of shortages, and the situation is expected to worsen without action from Congress," said Dr. Link in an ASCO statement on the Drug Shortage Prevention Act.

Dr. Link suggested that at least one provision in the bill addresses important issues.

"By giving the US Food and Drug Administration [FDA] greater ability to consider shortage issues in the drug approval and regulatory process, this legislation takes steps in bringing solutions to a dilemma faced by cancer doctors and their patients," he said.

But Dr. Link’s statement also suggests that the bill is not a complete remedy.

"ASCO is grateful for the leadership of Reps. Carney and Bucshon, and will continue to advocate for legislation that addresses the current drug shortage crisis and will prevent future shortages from occurring," he added.

The focus of the proposed Drug Shortage Prevention Act is, at least in part, on the machinations of the regulatory process, according to a press statement from Reps. Carney and Bucshon.

"The legislation mandates expedited review of drugs vulnerable to shortage in order to prevent shortages in the first place, and it requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages," the statement explains.

Notably, the press materials on the Drug Shortage Prevention Act do not specifically mention any would-be changes to generic drug reimbursement.

To date, the Drug Shortage Prevention Act has been endorsed by ASCO, the American Society for Parenteral and Enteral Nutrition, AstraZeneca, and the Hematology/Oncology Pharmacy Association.

Dr. Link reports receiving research funding from Seattle Genetics and Pfizer.

J Clin Oncol. Published online January 30, 2012. Abstract

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