WASHINGTON — For 14 years, cancer survivor Lori Barghini went through the grueling biennial process of checking to see if the slow-growing cancer in her thyroid had returned.
After beating the disease in 1985 and again in 1994, Barghini would quit her synthetic thyroid medication for five weeks, growing sluggish and gaining weight as the body’s thyroid hormones dissipated, then disappeared, and she became hypothyroid. When doctors pumped her full of radiation at the end of it all, any leftover thyroid cells they detected could be cancerous.
“It’s almost like, when you’re a kid in a pool and you decide you’re going to walk on the bottom of the pool and see how far you can walk and move your arms and try to talk,” said Barghini, an afternoon drive radio host on myTalk 107.1 FM. “It’s hard. Everything about you feels like it’s so slowed down.”
That was until 1998, when a drug called Thyrogen hit the market. The drug, delivered by two injections over three days, helps a patient go hypothyroid quickly and easily, “without the misery of five weeks of lousy side effects,” Barghini said.
Last year, Barghini’s doctors found suspicious thyroid cells and needed her to undergo a radiation scan. She planned on using Thyrogen to do so.
The only problem: there wasn’t any Thyrogen left.
Thyrogen is on the Food and Drug Administration’s hundreds-long drug shortage list, a tally of drugs in short supply that has almost quadrupled since 2005. President Obama issued an executive order in October trying to carve away at the list, and Minnesota Sen. Amy Klobuchar has been working to do the same in the U.S. Senate.
“It used to just be [an] anecdotal [problem],” Klobuchar said. “Now the numbers are showing this to be way more than anecdotal.”
‘It will bring down the crisis we’re seeing’
In February 2011, Klobuchar introduced a bill requiring drug companies to give advanced notice to the Food and Drug Administration if a drug shortage was on the horizon. The FDA sometimes has the power and resources to avert a drug shortage if given enough lead-time, and did so 195 times in 2011.
The drug shortage problem has progressively gotten worse over the past seven years at least. By the White House’s count, there were 61 products on the drug shortage list in 2005. Today, there are 231, Klobuchar said. More than half of those are caused by problems at factories or manufacturing and shipping delays, but a lack of raw materials and financial incentives (like a company merger, or a drug that doesn’t make enough money) can cause problems as well.
Early FDA notification is just an immediate policy change lawmakers are pursuing, Klobuchar said. Long-term fixes involving drug pricing and manufacturing are a ways off. The Senate Health, Education Labor and Pensions committee incorporated her provision in a medical device bill on April 25.
“We’re very confident that, while this will by no means solve the whole problem, it will bring down the crisis that we’re seeing,” she said.
Executive order
Klobuchar’s bill, should it pass (and it has bipartisan support), would be an extension of an Obama executive order issued in October meant to force early notification among drug manufacturers. Before the executive order, manufacturers only had to disclose the discontinuation of a drug produced by a single manufacturer. Obama endorsed Klobuchar’s legislation when issuing the order.
The FDA says more than 100 potential drug shortages have been averted since October alone. In February, the FDA highlighted two such successes — cancer drugs Doxil and methotrexate. Their manufacturers gave early notice that the drug supply was running low, and the FDA ordered alternatives, including a replacement drug from the United Arab Emirates.
For its part, the pharmaceutical industry says it’s willing to work with the government to put more stringent shortage safeguards in place. The Pharmaceutical Research and Manufacturers of America, the major lobbying shop for pharmaceutical companies, said it has “long been in favor of working with all stakeholders on targeted solutions to help prevent and mitigate drug shortages.”
“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 President John J. Castellani said in a statement. “PhRMA and its members have worked — and will continue to work — diligently to this common goal.”
Supplies rebounding
In Barghini’s case, she was placed on a Thyrogen waiting list, but her doctors warned there were more crucial patients in front of her. She thought of going to Canada to get a dosage, but Thyrogen’s manufacturer, Genzyme Corp., had warned that the drug is in short supply worldwide, so there’s no guarantee she would get it there.
Genzyme originally announced the shortage in October 2010. A company spokeswoman blamed it on “a transition to a new plant for its bottling and labeling.”
Last December, Genzyme announced a “more consistent and predictable” supply of Thyrogen this year. Spokeswoman Ingrid Esser said the company could meet about 80 percent of the demand in the United States right now. The drug is still on the FDA’s shortage list.
“We’re on track,” Esser said. “We see the progress going along nicely and hope that it continues to do that.”
For Barghini, that means working her way to the top of the waiting list.
“I’m just going to have to deal with it,” she said. “But I sure would like to know why this is going on and why other people are having trouble getting medications, whatever their issue might be. It just seems like that’s going backwards.”
Barghini said her doctors are convinced her number will be called and she’ll get a dosage of Thyrogen before July.
But if not, she said, “I’m probably going to have to kick it old school … which is just going to be a drag.”
Devin Henry can be reached at dhenry@minnpost.com. Follow him on Twitter: @dhenry
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