The following is from Dr. Craig Nichols, Co-Director of the Testicular Cancer Program at Virginia Mason Medical Center, member of the LIVESTRONG Board of Directors and Lance Armstrong?s oncologist.
It was 1996. A relatively unknown 25 year-old Lance Armstrong sat across from me in my office at Indiana University. He was struggling with the news that he had advanced, widely disseminated cancer in his abdomen, lungs and brain. At that moment, he was seeing a bright line being drawn across his life, dividing the ?before cancer? portion full of energy and optimism versus the ?after cancer? portion with looming disability, infertility, pain and quite possibly death.
My team and I developed a course of treatment for Lance that applied standard, readily-available medications and practices to achieve cure and high-quality survivorship. It?s the same course of treatment used for patients today. After brain surgery and rigorous chemotherapy, Lance recovered. He started a small foundation focused on fellow survivors, one that eventually grew into a global advocacy movement and national service provider for people affected by cancer. Then Lance took up his cycling career again and won an unprecedented seven Tour de France titles, becoming an inspiration to millions who embraced his triumphs with hope for their own battles against the disease.
Fast forward to the present. I’m often asked whether we gave Lance some sort of mythical special treatment or molecular wizardry reserved for celebrities and politicians. The answer is no. His recovery was due to tried-and-true treatments and medications like Cisplatin, a drug developed in the mid-1960s.Today, Cisplatin remains the cornerstone of cure for testicular cancer and is highly effective against many other malignancies. And this life-saving drug is on the Food and Drug Administration?s drug shortage list. Of the three manufacturers who produce Cisplatin, one has ceased production, a second has manufacturing challenges and the third can?t keep up with demand by itself.
Were Lance diagnosed today, the odds would be stacked against him.
For cancer and many other treatable diseases, effective and often inexpensive generic drugs are becoming scarce in the United States. More than 180 commonly-used drugs for anesthesia, infectious disease, arthritis and cancer are in desperately short supply. Americans are being forced to delay critical treatments or take substitutes, often suffering unnecessary pain and side effects.
The causes of this drug shortage crisis are many and complex. According to recent congressional testimony by the U.S. Department of Health and Human Services, three quarters of these shortages involve older, sterile injectable drugs. These are typically inexpensive drugs with low profit margins. Half of these sterile injectable drug shortages are due to product quality issues such as particulates and impurities. One fifth are due to production delays and capacity issues, and 11 percent are due to manufacturer discontinuations, usually for business reasons.
It is clear that market factors are playing a significant role in this problem, including industry consolidation and shortages of raw materials. While the Food and Drug Administration (FDA) does not have the authority to force drug companies to manufacture drugs in short supply, the agency is responsible for patient safety and must ensure that regulatory barriers within the drug approval process are not overly burdensome. In addition, Congress must ensure that the FDA has the necessary resources to address these problems and that the incentives are aligned properly to encourage manufacture.
Regardless of the causes, as a result of the shortage, physicians are forced to prioritize who gets life-saving treatment. Is it the young man with testicular cancer or the mother of three with ovarian cancer? Words can?t explain how terrible those decisions are or how frustrating it is to see this country regressing in its ability to provide access to high quality care.
And sadly, there are those all-too willing to exploit patients, insurers and states and offer drugs at 10 to 20 times the normal rate. To date, this price gouging remains perfectly legal.
Federal and state governments, professional societies and patient advocates are scrambling to address these unexpected challenges. Senator Amy Klobuchar and Representative Diana DeGette have introduced legislation that calls for manufacturers to give the Food and Drug Administration six months? notice before ceasing production on a prescription drug. It is a good first step. However, swift and urgent action is required by the federal government and by the pharmaceutical industry to provide for people in need of treatment today. End the price gouging now. Build solutions that assure Americans have access to the treatment and medications they need and deserve. And put measures in place that prevent this crisis from every happening again. Every day that this problem remains unsolved, we lose lives and cause unnecessary suffering.
From LIVESTRONG CEO Doug Ulman:
The drug shortage crisis requires immediate action by the federal government and the pharmaceutical industry. LIVESTRONG will work to ensure that patients? voices are represented during the search for solutions. We will also keep our spotlight trained on this issue and take every opportunity to remind manufacturers, elected officials and policy makers that failure to act is not an option. Americans expect and deserve solutions now.