John Kulik of Shaler should undergo his fifth treatment for bladder cancer today.
But because of a shortage of his medicine, Mr. Kulik, 85, is one of 12 patients at the University of Pittsburgh Medical Center whose treatment has been halted. And this shortage is nationwide: The Bladder Cancer Advocacy Network estimates that up to 30,000 people may not be receiving the treatment they need.
"I'm just kind of shooting blanks here trying to figure out what to do," said Mr. Kulik, who received just three of the six required dosages after surgery in April to remove cancerous cells in his bladder. He should have received the fourth treatment last week.
The drug, BCG, works to prevent recurrence of the cancer that has a 50 to 80 percent chance of coming back.
After his doctor told him there was no more medicine, Mr. Kulik asked his doctor: " 'What should we do?' and he said, 'I guess you can write your congressman.' "
The House and Senate late last month did pass bills that would require drugmakers to notify the Food and Drug Administration when they expect disruption to production of medicine and are now working to merge the bills.
BCG is one of 21 cancer drugs currently in shortage nationwide, according to the American Cancer Society. In 2011, more than 200 cancer drugs were in shortage, said Len Lichtenfeld, the society's national deputy medical chief.
"The patient goes in... and then the doctor says, 'I'm sorry, we can't treat you because we don't have the drug, and we can't find it anywhere,' " Dr. Lichtenfeld said.
Companies need to communicate with doctors and the FDA in advance when a shortage seems imminent, he said. "This is no way to treat patients who have a serious illness."
Mr. Kulik's doctor, Benjamin Davies, a UPMC urologist, had six patients initially affected by the BCG shortage: three who could not start their treatments and three who could not continue.
"It's a total nightmare," Dr. Davies said about the shortage.
BCG is the only treatment approved by the FDA for bladder cancer, said Diane Quale, president of the cancer advocacy network that has been lobbying the FDA to recruit new suppliers of the drug. Alternatives, like chemotherapy and radiation treatments, are available, but have more severe side effects and are not proven to be as effective against bladder cancer. Doctors can try "old-fashioned drugs that aren't very good," or experiment with options that can be as much as five times more expensive than BCG, said Michael O'Donnell, a urologist at the University of Iowa who has worked on alternative treatments. The unproven treatments may not always be covered by patients' insurance, Dr. O'Donnell said, meaning doctors are afraid to use them in case the hospital has to foot the hefty bill.
Changing therapies when the patient's treatment is interrupted can be dangerous, said Donald Lamm, a urologist in Phoenix, who pioneered the use of BCG for bladder cancer.
"We really can't switch mid-course from BCG to a chemotherapy," he said. "It could potentially be counterproductive."
BCG is manufactured by only two companies -- one of which, Sanofi-Pasteur, paused production at the end of April. The shortage was due to a "manufacturing delay," said Len Lavenda, a spokesman for Sanofi-Pasteur. Though there were no quality problems with the last batch of BCG, Mr. Lavenda said the company is holding the supply because it needs to re-evaluate its review process. He would not elaborate on details about the evaluation.
Merck, the other company that produces BCG, is increasing its production now that it is the only manufacturer on the market.
"Right now, we're meeting the demand," said Bob Consalvo, a spokesman for Merck, who supplies UPMC where Mr. Kulik is being treated. Though Merck increased production, Mr. Consalvo said he can't predict future demand if the shortage persists.
Courtney McCrimmon, a spokesperson for UPMC, said Thursday afternoon the pharmacy had received a new shipment of drugs from Merck. She predicted affected patients, including Mr. Kulik, should be able to re-start treatment soon. Mr. Kulik, when reached Thursday afternoon, had not yet been notified.
But Dr. Davies said the shipment UPMC received is a limited, stop-gap supply.
"I think we're good in the short term. But I have no confidence that we're good in the long term," he said. "There is a national crisis of intravesical chemotherapy, and it has not been handled well by the drug companies. This is just one manifestation of it."
The legislation being pushed in Washington is expected to be sent to President Barack Obama before Congress takes its August recess. Under the measures, federal officials would have to take steps to "help mitigate or prevent" the shortages, perhaps by finding other sources of supply, in this country or abroad. Manufacturers would also have to inform the FDA before shutting down production of certain drugs.
Still, the legislation won't do anything to address the current shortages or offer incentives for generic drugmakers to continue producing older, cheaper drugs.
Cynthia Kinsella, president of the American Bladder Cancer Society, said patients who are told BCG is not available because of a drug shortage should report the situation to the FDA by emailing CBERshortage@fda.hhs.gov or calling 1-301-827-4239.region - health
The New York Times contributed. Sanjena Sathian: email@example.com or 412-263-1408. First Published June 8, 2012 4:00 AM