Reporting Denise Koch
BALTIMORE (WJZ) — What if you need a certain medicine, maybe one that would save your life, and you can’t get it? WJZ investigates prescription drug shortages. Denise Koch talks with University of Maryland women’s basketball coach Brenda Frese about her very personal fight to find a solution.
You’d never know it now, but not too long ago one of these twins nearly died.
“They told me he had only a matter of weeks to live,” said Mark Thomas, Tyler’s father.
University of Maryland women’s basketball coach Brenda Frese and her husband Mark remember the moment doctors told them their son Tyler had leukemia.
“Obviously you feel helpless,” said Frese. “You’re thinking the worst. My initial thought that whole night without being educated was ‘How much time do I have left with my son?’”
Doctors at Johns Hopkins Hospital immediately started pumping chemotherapy drugs into Tyler to stop the fast moving disease.
“These chemicals are doing these things to your child, yet they’re also saving his life,” said Thomas.
It was only after his chemotherapy that Thomas and Frese discovered the miracle drug that saved their son might not be there for others.
In short supply, its cost had skyrocketed from $12 a vial to nearly a thousand. They worried about parents who couldn’t afford it, knowing their children could die.
“I can’t imagine them telling us, ‘Yeah, there’s a drug that’s gonna help save your kid’s life, but it’s not available,’” said Thomas.
And it isn’t just one drug. Pharmacists and doctors tell WJZ drug shortages more than tripled in the last six years.
“I’d be surprised if 2012 isn’t worse because we’re still dealing with the shortages. They still keep rolling in,” said John Lewin, Maryland Pharmacy Coalition.
So why is this happening now? Aside from production problems, once a drug turns generic, profits plummet so there’s less incentive to make it.
Doctors blame drug makers.
“It’s just not worth their while to make the very cheap drugs any longer,” said Dr. Ram Trehan, oncologist.
But drug makers deny that, saying they can’t keep up with increased demand for certain medications. That means there are times doctors cannot get the very drug that could save your life…or you can’t afford it.
“I have had at least two patients who could not afford their drugs and decided to go the hospice route,” said Trehan.
“These people who are wanting to gain a profit, what would their life look like if their son or daughter was someone that needed this drug,” said Frese.
Frese and Thomas turned anger into action, asking lawmakers to investigate.
Maryland Congressman Elijah Cummings is outraged.
“Basically what you’re doing is stealing someone’s life. If we can’t take care of Americans when they’re going through illness, if we can’t make sure they’re not taken advantage of, we need to go home and do something else,” said Cummings.
“I’d like to put my foot in these people’s rear end and get them going. Maybe if it happens to one of their family members, they’ll do it,” said Thomas.
The FDA plans to work more closely with drug makers to manage the shortage and improve the supply. You can find a link to the FDA’s list of current drug shortages here.
In a statement, Pharmaceutical Research and Manufacturers of America President and CEO John J. Castellani said, “Patient access to innovative treatments is the cornerstone of our industry. That is why the critically important issue of drug shortages demands our collective attention to ensure patients can access the medicines they need in the most expeditious manner possible. America’s innovative biopharmaceutical companies have long worked to prevent drug shortages in advance, and will continue to work closely with the FDA to prevent manufacturing disruptions.
While the majority of drug shortages involve generic drugs, with FDA specifically referring to an increase in shortages among `older sterile injectable drugs,’ this problem concerns us all and requires our combined attention.
As FDA, Congress and other experts have noted, the factors that contribute to drug shortages are complex and multidimensional, and it is important for all of us who provide life-saving medications to work collaboratively to minimize unexpected disruptions in the supply of vital medicines.
In the instance a shortage is anticipated, an innovator or generic manufacturer is encouraged to notify the FDA in order to address, avert and mitigate drug shortages. In the event there is a discontinuation of sole source, medically necessary drugs, companies are required to inform FDA six months in advance. Manufacturers have stepped up the voluntary reporting of anticipated events that might lead to drug shortages, and according to the FDA, in 2011, this early notification helped prevent 99 shortages.
Addressing anticipated occurrences of a drug shortage early in the process helps both health care providers and manufacturers identify treatment alternatives more efficiently, and we will continue to work with FDA to improve upon existing reporting requirements.
Additionally, price gouging by secondary wholesalers is unacceptable. The `gray market’ presents serious concerns for patient safety as it cannot be assured that the products obtained by providers in this manner have been handled in a way that maintains product integrity.
Patients concerned that their medicine may be in short supply have several options available, including visiting the FDA’s Current Drug Shortages page to see if the drug has been reported in short supply or talking with your doctor, who may be able to offer another effective medicine.
It is critical that we seek a more comprehensive understanding of the many circumstances that can lead to a drug shortage as industry, Congress, FDA, patients, providers and other stakeholders try to identify meaningful ways to help alleviate, mitigate and address this critical problem. PhRMA and its members have worked—and will continue to work–diligently to this common goal.”