Federal officials and lawmakers, along with the drug industry and doctors’ groups, are rushing to find remedies for critical shortages of drugs to treat a number of life-threatening illnesses, including bacterial infection and several forms of cancer.
The proposed solutions, which include a national stockpile of cancer medicines and a nonprofit company that will import drugs and eventually make them, are still in the early or planning stages. But the sense of alarm is widespread.
“These shortages are just killing us,” said Dr. Michael Link, president of the American Society of Clinical Oncology, the nation’s largest alliance of cancer doctors. “These drugs save lives, and it’s unconscionable that medicines that cost a couple of bucks a vial are unavailable.”
So far this year, at least 180 drugs that are crucial for treating childhood leukemia, breast and colon cancer, infections and other diseases have been declared in short supply — a record number.
Prices for some have risen as much as twentyfold, and clinical trials for some experimental cures have been delayed because the studies must also offer older medicines that cannot be reliably provided.
On Wednesday, Dianne Nomikos, 65, went to M. D. Anderson Cancer Center in Houston for a 9 a.m. appointment to receive Doxil, a vital medicine for her ovarian cancer. She was told to go home and wait until new supplies arrived.
“My life is in jeopardy,” she said through tears in a telephone interview. “Without the drug, who knows what’s going to happen to me?”
The Obama administration is considering creating a government stockpile of crucial cancer medicines. The Centers for Disease Control and Prevention already stockpile antibiotics, antidotes and other drugs needed in the event of a terrorist attack or earthquake.
Under one plan, the government would store the dry ingredients for cancer drugs and, in the face of a shortage, distribute them to hospitals, where pharmacists could mix them into injectable compounds.
Dr. Richard Schilsky, a professor of medicine at the University of Chicago, said the number of cancers diagnosed in a 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.
Legislation proposed in both the House and the Senate would give the Food and Drug Administration the power to demand that drug makers give early warnings of possible supply disruptions. Senator Amy Klobuchar, Democrat of Minnesota, said the idea behind the bipartisan bill came after she found that the agency had prevented 38 shortages last year after getting early alerts of problems at drug makers.
“I can’t say the drug companies are excited” about the proposed legislation, she said in an interview. “But we need to give the F.D.A. more time.”
A group of leading oncologists has started a not-for-profit drug company that it hopes will soon be able to import supplies of some of the missing medicines. The company will eventually manufacture the drugs itself, according to Dr. George Tidmarsh, a pediatric oncologist and biotechnology entrepreneur who will lead it.
“We have a meeting with the F.D.A. next week,” Dr. Tidmarsh said. “This unfolding tragedy must stop, and right now.”
More than half the recent shortages have resulted because government or company inspectors found problems like microbial contamination that can be lethal on injection. Others have occurred because of capacity problems at drug plants or lack of interest because of low profits, according to the F.D.A.
Doxil, the cancer drug Ms. Nomikos needs, is made by Johnson & Johnson. Monica Neufang, a company spokeswoman, said, “Our third-party manufacturer has had some manufacturing issues related to capacity.”
Heather Bresch, president of the generic drug giant Mylan, says the shortages grow out of a sweeping consolidation of the generic drug industry into a few behemoths that compete only on price and have 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,” Ms. 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.”
Ms. Bresch has helped to broker an agreement that would require the industry to pay $299 million a year for increased inspections of foreign drug plants, a deal that must be approved by Congress and one she says will prevent some shortages.
Top government officials have held a blizzard of meetings in recent weeks to tackle the shortage issue, and more are expected over the next month — including a public advisory meeting at the F.D.A. and hearings in Congress.
“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.
A crucial problem is disconnection between the free market and required government regulation. Prices for many older medicines are low until the drugs are in short supply; then prices soar. But these higher prices do little to encourage more supply, because it can be difficult and expensive to overcome the technical and regulatory hurdles. And if supplies return to normal, prices plunge.
Executives at Premier, a hospital buying cooperative, said that in April and May its members received hundreds of offers from obscure drug wholesalers to sell drugs in short supply at vastly inflated prices. Of the 636 offers that included a price, 45 percent were at least 10 times the normal rate and 27 percent were at least 20 times normal.
Such sales offers are legal as long as suppliers prove that they bought the drugs appropriately. Some wholesalers buy certain drugs in large quantities because they are betting there will be a shortage. The excessive buying can help make their predictions come true. “We never like to see a situation where people can profit off of a national crisis and engage in price gouging,” Mike Alkire, Premier’s chief operating officer, said in an interview.
Joyce Burke, 47, of Mooresville, N.C., has breast cancer and is worried that she might not be able to get Taxol, which is in short supply. A drug that might have been substituted for Taxol has a side effect that leads some patients to lose their fingernails.
“I was not looking forward to losing my fingernails,” she said.
On Thursday, she received her first dose of Taxol, and her doctor said he had secured enough of the drug to give her a second dose in a little more than a week. She will need four doses to complete the treatment.
“And I asked, ‘What happens if you can’t find the rest?’ ” Ms. Burke said. “It’s not nearly as effective if you switch drugs midway through.”
Source: The New York Times August 20, 2011