COMMENTARY

Drug Shortages: A Problem for Everyone

John M. Maris, MD

Disclosures

January 20, 2012

Editorial Collaboration

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My name is John Maris and I am Chief of Oncology at the Children's Hospital of Philadelphia. I have just returned from Capitol Hill where I had a chance to testify in the Senate about a problem that I think is very prevalent in medicine today and one that has the potential to really grow, and that is the problem of drug shortages.

For complicated reasons, many of the drugs that we as physicians rely on each day -- anticancer drugs, antibiotics, anesthetics, medicines that go in IV nutrition -- simply are just not available. These are generally generic, so-called sterile injectable drugs, difficult to manufacture, often very, very commonly used around the world, but for reasons of manufacturing, regulation, and many other issues, many of these are just not available today. At any one time in America today there are about 300 drugs that are in limited supply or simply not available as compared to dozens in the past.

Here at the Children's Hospital of Philadelphia, this has had a major impact. We track this issue on a day-to-day basis. We have invested a significant amount of resources in both monitoring the problem and, because we have small patients, stretching our supply. We use advanced robotics to make sure that every little drop is allocated the best way we can. This is how we have responded to the problem here, but still, as I sit here today, there are 8 drugs that would normally be prescribed by one of our doctors that just are not available.

This is beginning to have an impact. There is no doubt about it. In the cancer world, there are plenty of stories of patients either on therapy who cannot receive a drug that they have been receiving that has been effective or, in a pediatric cancer community, known curative medicines that we just cannot get. Despite all the systems that we have set up here at Children's Hospital, for 6 weeks this past summer we were unable to get a drug called daunorubicin. Daunorubicin was discovered decades ago. It has been tested in multiple clinical trials and clearly is a curative drug for leukemia, but we could not get it. There are other drugs available for leukemia and we met, talked, and substituted a medicine for daunorubicin that, as of today, we do not know was as effective. It clearly was more toxic, the children clearly got sicker than they would have if they were to receive the standard medicine, and it was an uncomfortable and not satisfactory substitution. It highlights the issue that the infrastructure in medicine today -- in oncology, for sure, but in all branches of medicine -- is built on decades of evidence. When one part of that armamentarium is missing, that can have very significant consequences.

The other very important impact that this is having is on our research mission. I think that it is clear to everyone in this audience that curing cancer, for example, is not going to occur because of a new drug that is going to replace all the old drugs. In fact, we make our advancements by integrating new discoveries into the backbone of what we have. It is incredibly frustrating for us to develop a new drug, to have the excitement and the ability to want to test it on a backbone, but to not have that backbone available.

What is really slowing clinical research in oncology right now is the inability to get some of the generic drugs that we need to use as part of the clinical trials. That impact is potentially devastating.

I am very encouraged that our leaders in Congress and the President have recognized this issue. Senators [Robert] Casey (D-Pennsylvania) and [Amy] Klobuchar [D-Minnesota] recently introduced a bill in the Senate [S. 296] that takes what I think is a very important first step, which is to take the surprise out of this issue. Sometimes drug shortages hit the medical community without any warning, and the Casey-Klobuchar bill requires immediate notification to the US Food and Drug Administration (FDA). President Obama has issued an executive order that codifies notification and now makes it essential and required for manufacturers.

However, this is just a step in the right direction, and it is only a first step. The testimony presented in the US Senate Committee on Health, Education, Labor, and Pensions was quite informative. I think that there was a bipartisan recognition that this is an issue that we need to solve together. It is a complicated problem and there is not a single solution. We are in a resource-limited time and that is tough, but I think that there is broad recognition that we have dodged a bullet to date. We have been able to mix and match and get away with a growing problem. I think that there is clear recognition that this is something that has the potential to turn into a real disaster and affect patients' lives directly and needs to be addressed.

Potential solutions are multifaceted. Clearly, the FDA is underresourced and we have to figure out, in this very resource-limited time, how to get the FDA the resources they need to work with the manufacturers to make sure that drugs continue to be made even if there is not a pending shortage.

There are clearly people who are profiting from this problem. It is a supply-and-demand issue. Those individuals that are hoarding drugs and selling them at sometimes 100-200 times the standard price need to be weeded out. We need to figure out how to stop that practice, which is certainly contributing to the problem.

Finally, we have to find a mutual way to incentivize the continued manufacturing of these essential drugs. There clearly has to be a business model that works for everyone. As a community, healthcare, government, and the manufacturing industry have to come together on this issue. Clearly, if there is one issue that should engender bipartisan support on the Hill, it is this issue. To date we have dodged a bullet and we have been able to mix and match and figure out ways around this problem. However, if this problem is left unaddressed, it is going to result in patient deaths. It is going to result in significant morbidity and mortality. It is something that we need to address now before it affects the patients that we serve.

Thank you for your attention.

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