A health crisis the companies caused

November 9, 2011

Nicole Colson explains why the U.S. is facing a shortage of certain lifesaving drugs.

IT SOUNDS like a problem striking poor and developing countries: shortages of critical, lifesaving drugs, resulting in severely compromised patient care and delays in important studies in the treatment of cancer and other serious diseases.

But it's happening right here in the U.S.--the world's wealthiest nation.

According to recent reports, drug shortages in the U.S. have spiked in recent years--nearly tripling from 61 drugs in 2005 to 178 in 2010. That number is expected to be even higher by the end of 2011. According to the Food and Drug Administration (FDA), the main drugs affected are cancer drugs, anesthetics, electrolytes and various other drugs used in emergency rooms.

According to Bloomberg News, more than half of hospitals and medical centers surveyed by the American Society of Health-System Pharmacists said that drug shortages had compromised patient care in the past year.

Howard Koh, an assistant secretary of health for the Department of Health and Human Services, recently testified to Congress that these drug shortages are causing hundreds of clinical trials to be stopped or delayed. As Koh told Congress in writing in September, "The inability to obtain adequate supplies of these cancer drugs for research has resulted in promising clinical trials being suspended indefinitely and patient enrollment being abruptly halted." More than 300 clinical studies being paid for by the National Cancer Institute involve a drug that is in short supply, according to Koh.

President Obama, flanked by Health and Human Services Secretary Kathleen Sebelius and cancer patient Jay Cuetara
President Obama, flanked by Health and Human Services Secretary Kathleen Sebelius and cancer patient Jay Cuetara

In an interview with NPR the same month, Koh called the shortages nothing short of "a dire public health situation."

According to the Wall Street Journal, some of the cancer drugs in short supply include decades-old chemotherapy drugs that "are still the backbone of cancer treatment...[including] doxorubicin, often used to treat breast cancer, and cytarabine, a leukemia drug that has no substitute."

Frighteningly, because drug companies are not legally required to notify anyone when they've stopped making a drug, hospitals and physicians can sometimes be left in the lurch, scrambling to provide alternative treatments or forced to delay treatment for critically ill patients while they search for an alternative source.

A majority of hospitals have actually been forced, according to the Journal, to ration drugs this year as a result of the shortage of key cancer and other critical-care drugs. Hospitals and clinics have also reported delaying cancer treatment or switching to alternative drugs that might not be as effective as a result of the shortages.

According to an Associated Press review of industry reports and interviews with experts, there were at least 15 patient deaths in the past 15 months that can be directly attributed to the drug shortages--either because the right drug wasn't available or because of dosing errors or other problems in administering or preparing alternative medicines. The actual number of deaths is likely much higher, say experts.

In the worst case, earlier this year there were nine patient deaths and 10 other patients harmed in Alabama due to bacterial contamination of a hand-mixed batch of liquid nutrition given via feeding tubes--because the sterile pre-mixed liquid wasn't available.

"How, in the United States of America, could critical lifesaving or life-prolonging drugs be in short supply?" asked Jay Cuetara, a cancer patient who said his chemotherapy was delayed when his hospital ran out of the drugs, at a press conference held by the Obama administration in late October.


WHAT'S TO blame for this shortfall of critical drugs? Simply put, the profit-seeking behavior of pharmaceutical companies.

As the Wall Street Journal reported:

Most of the shortages involve older drugs administered by injection or intravenously...They are mainly generic, not highly profitable and are now made by only one or two companies...

The shortages are growing more severe, in part because of industry consolidation and manufacturing problems in the past year. When one company runs into a manufacturing problem with a product or decides to quit making a drug, competing companies can't quickly fill the void.

As Salon.com columnist Mary Elizabeth Williams, herself a cancer survivor, noted last month, "Because the profit margins on several of these drugs are small, companies have less incentive to keep making them."

The Associated Press reported, "Companies [are] abandoning the injected generic drug market because the profit margins are slim. Producing these sterile medicines is far more complicated and expensive than stamping out pills, and it can take about three weeks to produce a batch."

But some people are making out like bandits in this crisis. Some 97 percent of hospitals and medical centers surveyed by the American Society of Health-System Pharmacists said the drug shortages drove up costs through purchases from so-called "gray market" resellers. Such resellers, according to a report by Premier Healthcare Alliance, inflate prices by an average of 650 percent. One leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial--more than 80 times higher--while a drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200 due to a drug shortage.

According to the Associated Press:

The drugs with the highest markups were for critically ill patients needing anesthesia or other medicines for surgery or for emergency care, cancer, infectious diseases and pain management...

The pitches hospitals get from the secondary distributors generally say they have small batches of specific drugs that are hard or impossible to find. "Are you enjoying this crazy 'roller coaster ride' of pharmaceutical shortages?...I utilize over 60 vendors to locate and procure needed pharmaceuticals to assist when you have shortage needs," one reads.


IN LATE October, the Obama administration finally addressed the crisis, with Obama ordering the FDA to take new steps to send out early warnings about looming shortages and try to avert them. "Even though the FDA has successfully prevented an actual crisis, this is one of those slow-rolling problems that could end up resulting in disaster for patients and health care facilities all over the country," Obama said.

The families of the 15 patients documented to have died as a result of drug shortages might disagree with the Obama administration on whether we're in an "actual" crisis, of course.

Additionally, Obama ordered the FDA to work with the Justice Department to "examine whether potential shortages have led to illegal price gouging or stockpiling of life-saving medications." Likewise, the FDA is reportedly planning to more than double the size of its office dealing with shortages--to a whopping 11 people.

The Obama administration also announced that it "sent a letter to drug manufacturers reminding them of their responsibility to report the discontinuation of certain drugs to the FDA. The letter also encourages companies to voluntarily disclose to FDA potential prescription drug shortages in cases where disclosure is not currently required by law."

Well, that's telling them!

Realistically, such measures amount to little more than a drop in the bucket and will do little to solve the ongoing crisis. While an early warning system is necessary in order to not leave patients and hospitals scrambling for critical drugs, if a manufacturer decides to stop production on a key drug and no other company steps forward to start making it (because profit margins are deemed too low, for example), patients and hospitals will still be left without the drugs they desperately need.

And although it's illegal for pharmaceutical companies to create a monopoly or conspire to create a medicine shortage (and thus artificially raise prices), there's currently no federal law against price gouging on prescription drugs,

The Bloomberg News declared:

The administration's plan won't ease shortages because drug makers have little incentive to raise output when Medicare and Medicaid, the two big U.S. public health programs, limit how fast the price of a drug can rise, said Devon Herrick, senior fellow at the national Center for Policy Analysis, a policy research organization in Dallas.

"Firms have little incentive to ramp up production," Herrick said.

It's true that firms have little incentive to ramp up production--but the main problem isn't the price controls instituted by Medicare and Medicaid on drug manufacturers.

Instead, the real problem is that health care overall, and the pharmaceutical industry in particular, is a for-profit system. In fact, the decision of multimillion-dollar pharmaceutical companies to discontinue making a lifesaving generic drug makes a perverse sort of sense under a system in which profit margins dictate the logic of which drugs get produced. After all, why produce a low-profit generic antibiotic, when you could instead be developing new patents on more profitable drugs like the next Viagra?

According to the Associated Press, for example, "shortages of a common cancer drug named leucovorin didn't start until the FDA approved a similar competitor that worked as well but, because it was new, was 58 times more expensive."

Sometimes, "you have to look the patient in the eye and say, 'I can't treat you. I certainly can't treat you the way I meant to treat you,'" Dr. James Speyer, medical director of the clinical cancer center at New York University Langone Medical Center, told the Associated Press.

Speyer said, "Obama's action is important but doesn't address one key part of the problem--drug profits...Unfortunately, we're going to be living with the problems of these shortages for some time."

Republicans, of course, were quick to condemn even Obama's token stand against the pharmaceutical industry, saying that the "real problem" was price controls instituted by Medicare and Medicaid. In other words, lift the price controls and let the "free market" sort it out.

But there's no real solution to be found in manufacturing these drugs only to price them out of the reach of vast numbers of people (especially the 50 million Americans who lack health insurance).

As Mary Elizabeth Williams put it:

Survival isn't just for those who, as Herman Cain puts it, can only "blame yourselves" for not being rich. And death and disease are not just for those who, like Ron Paul, think that's "what freedom is all about--taking your own risks."

All the riches and "freedom" in the world won't save your ass if you don't have access to the right treatment. And when effective medicine isn't getting out there because the financial incentive isn't compelling enough, it's just plain sickening.

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