Public healthLawmakers struggling to end critical medicine shortage

Critical shortages for medicines needed in treating life-threatening illnesses have lawmakers and public health officials scrambling to find solutions.

This year alone, a record high of more than 180 drugs crucial for treating childhood leukemia, breast and colon cancer, infections, and other diseases have been declared in short supply.

“These shortages are just killing us,” said Dr. Michael Link, the president of the American Society of Clinical Oncology. “These drugs save lives, and it’s unconscionable that medicines that cost a couple of bucks a vial are unavailable.”

The shortages have resulted in dramatically inflated prices for remaining supplies with some drugs costing as much as twenty times more. In addition clinical trials for some experimental cures have been delayed because the studies cannot reliably obtain older medicines, which they must also offer.

Patients like Dianne Nomikos, a sixty-five year old woman with ovarian cancer, have been turned away by their doctors because they do not have the medicines available to continue their treatments. Last week, Nomikos was told by the M. D. Anderson Cancer Center in Houston to return home because they no longer had Doxil, a vital medicine for her ovarian cancer.

“My life is in jeopardy,” she said in a tearful interview with the New York Times. “Without the drug, who knows what’s going to happen to me?”

“Drug shortages represent a pressing public health issue, and we are actively working to understand the causes, the full scope of the problem in the U.S. and internationally, and possible solutions,” said Dr. Howard K. Koh, an assistant secretary for health.

More than half of the recent shortages have been the result of microbial contamination, which can prove lethal if administered, while other shortages have been caused by capacity problems at manufacturing plants or a lack of interest from pharmaceuticals because of low profits.

According to Monica Neufang, a Johnson & Johnson company spokesman, Doxil, the cancer medication Nomikos needs, is in short supply because their “third-party manufacturer has had some manufacturing issues related to capacity.”

Heather Bresch, the president of the generic drug giant Mylan, explained that the recent drug shortages stem from the increasing consolidation of the generic drug industry where now only a few giant companies compete solely on price using foreign plants that are rarely inspected.

“The race to the bottom has led to an increase of products coming from plants in China and India that may have uncertain supply and may have never been inspected,” Bresch said. “If the F.D.A. was required to inspect foreign drug plants at the same rate it does domestic ones, we might not have so many of these shortages.”

To that end, Bresch is currently working with Congress to pass a deal that would require the pharmaceutical industry to pay $299 million a year for increased inspections at foreign drug plants. If approved by Congress, Bresch says it will prevent some shortages.

The Obama administration is also considering creating a government stockpile of critical cancer medicines. The Centers for Disease Control and Prevention (CDC) currently stockpiles antibiotics, antidotes, and other medicines that are necessary in a terrorist attack or major natural disaster.

One proposed solution would be for the government to store dry ingredients for cancer drugs and in the event of a shortage, it could distribute them to hospitals where doctors could then mix them into injectable compounds.

Dr. Richard Schilsky, a professor of medicine at the University of Chicago, said the number of cancers diagnosed each year was easy to predict. “So we ought to be able to make a pretty good estimate of the grams required to treat every patient in the country in any given year,” he said.

Finally a proposed bill in both the House and Senate would empower the Food and Drug Administration to require drug manufacturers to give early warnings of possible supply disruptions.

Senator Amy Klobuchar (D – Minnesota) said the concept behind bipartisan bill stems from the fact that last year the FDA prevented thirty-eight shortages after it received early alerts of problems from drug makers.