Transcript: Testimony of Dr. Michelle Hudspeth on the drug shortage crisis

House Oversight and Government Reform Committee

“Drug Shortage Crisis: Lives are in the Balance” hearing held on Nov. 30, 2011 by the Subcommittee on Health Care, District of Columbia, Census, and the National Archives

Transcript of testimony by Dr. Michelle Hudspeth, Division of Pediatric Hematology/Oncology of Medical University of South Carolina:

Dr. Michelle Hudspeth, Division of Pediatric Hematology/Oncology of Medical University of South Carolina. IMAGE SOURCE:

“Chairman and members of the subcommittee, thank you for inviting me here to testify today. I am the chief of the division on pediatric hematology/oncology and the director of pediatric blood marrow transplantation at the Medical University of South Carolina in Charleston, South Carolina.

“I care for close to 75 newly-diagnosed cancer patients each year who are children as well as 30 patients who undergo bone marrow transplants for the best chances of survival in childhood cancer.

“The National Cancer Act in 1971 officially declared the war on cancer. Since that time, the overall survival rate of childhood cancer has dramatically improved from 10% to almost 80%. However, the incidents of childhood cancer has continued to increase over the past 20 years, and cancer remains the leading cause of death from disease of children.

“In 23 days, we will mark the 40th anniversary of the National Cancer Act being signed into law. Today, unfortunately we mark the largest number of chemotherapy drugs ever in shortage. The war on cancer has been reduced to a mere skirmish with no weapons and no clear battle plan.

“Just a few days ago, I was with a family in crisis at our pediatric emergency room. I had to tell the parents of a two-year-old little boy that he has high risk, acute lymphoblastic leukemia. This type of leukemia is the most common childhood cancer. For his first month of treatment, he needs four drugs plus another two chemotherapy drugs injected into his spinal fluid. Five of his six drugs are in shortage. Each of these drugs in shortage is a generic drug. Mercifully, we have the drugs right now. I held his mother’s hand and told her we’ll do everything humanly possible to cure her son. He needs three-and-a-half years of chemotherapy treatments. Will I be able to tell her the same thing next month? In six months? Or even in a year?

“The scope of the problem continues to intensify. Between 2005 and 2010, the number of prescription drug shortages nearly tripled in the U.S. Currently, 21 chemotherapy drugs are in shortage as well as two essential chemoprotectant drugs.

“The vast majority of drugs in shortage are generic and used to treat curable childhood cancers. Clearly, the most critical problem is a child being denied curative cancer treatment because of a drug shortage.

“Furthermore, the additional downstream effects of chemotherapy shortages have significant ramifications as well. Research cures cancer. The major advancements of pediatric cancer have occurred through the Clinical Trials Cooperative Group funded by the NCI [National Cancer Institute]. The majority of clinical trials incorporate elements of standard treatments into one or more treatment groups in the trial. Clinical trial enrollment is not currently allowed if you do not have access to the standard treatment. As a result, clinical trial enrollment is declining. Not only does this undermine the advances of cancer treatments, but it comes with a significant financial cost as well. Cooperative Group clinical trials have regulatory costs that add up. Consequently, up to $1.2 million could be spent in one year alone for pediatric cancer clinical trials that are not able to enroll a single patient.

“A recent study published in the American Journal of Health-System Pharmacy reported that overall personnel costs associated with managing the drug shortages cost an estimated $260 million each year.

“Regrettably, most institutions have had to institute a review board, often with an ethics committee, to develop harrowing plans of how to ration chemotherapy drugs, most of which are generic drugs that have been available for 30 years or more. How do you decide who should be given a chance to live?

“In an effort to maintain some semblance of adequate chemotherapy treatment, drug substitutions are being made with less familiar products. Additionally, pharmacies are stocking multiple concentrations of the same drug. This can easily lead to dosing errors, either underdosing or overdosing when one concentration of drug is mixed as if it is the other concentration. Chemotherapy agents are high alert drugs; they have a very narrow therapeutic index, meaning there’s a very small difference in the amount that gives benefit and the amount that causes death.

“Over a year ago, a national survey by the Institute of Safe Medication Practices noticed that 35% of respondents reported a near-miss error due to drug shortages. 25% reported actual errors that reached the patient. One-third of physicians reported an adverse patient outcome due to drug shortages.

“As with any issue, there is multiple reasons for the current drug shortage. However, the timing is notable. In 2003, the Medicare Modernization Act was put into place. In 2004, the FDA reported 58 drug shortages. In 2011, the number skyrocketed to over 200. The intent of the MMA was to create more transparency in pricing. However, generic prices are driven down by market competition. In their current under the the MMA, it makes it difficult for companies to raise prices more than 6% per year. Product margins have fallen significantly for many generic drugs, leaving companies with no incentive to continue manufacturing the drug or to increase production.

“The current situation is nothing short of a massive national emergency. The burden is on us to resolve the crisis to protect our children. None of my patients’ families ever thought that they’d be faced with the diagnosis of childhood cancer. Today alone in the U.S. the parents of 36 children will be told, ‘Your child has cancer.’ Let’s act to ensure that these parents can also be told, ‘We have drug available to cure your child.’

“Thank you.”



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