Michael P. Link, MD
The last thing an oncologist wants to hear is that a medication he or she has prescribed is unavailable. But the reality is that drug shortages, while not new, have reached a crisis level. The medications in short supply run across multiple specialties, but the impact is most prevalent—and devastating—in oncology.
The American Cancer Society reports that patients with lung, breast, ovarian, and rarer forms of cancer face the biggest health risks when medications like paclitaxel, fluorouracil, doxorubicin, and bleomycin are scarce. An alternate drug may not work as well, and there may be increased side effects.
A recent statistic points to the magnitude of the problem: an IMS Institute for Healthcare Informatics analysis found that 550,000 cancer patients were impacted by the drug shortage as of June 30, 2011.
One of the more prominent leaders working toward a solution is Michael P. Link, MD, president of the American Society of Clinical Oncology (ASCO). This past summer, Link addressed the drug shortage problem at a Capitol Hill briefing. ASCO’s influence also was evident when, on November 30, 2011, the US House of Representatives Oversight and Government Reform Subcommittee on Health Care, District of Columbia, Census and the National Archives held a hearing on drug shortages.
Testimony ranged from declaring the situation a “massive national emergency” to calling on the FDA to accelerate regulatory processes that help resolve drug shortages.
In addition to his role as ASCO president, Link also serves as the Lydia J. Lee Professor of Pediatric Hematology/Oncology at Stanford University School of Medicine and director of the Bass Center for Cancer and Blood Diseases at the Lucile Salter Packard Children’s Hospital at Stanford. Link recently spoke with our oncology editors to discuss the impact of drug shortages.How common are drug shortages?
Let me start by saying that this is an issue that is not only related to oncologic drugs. It relates mostly to generics, but includes antibiotics and anesthetic drugs, as well as oncologic drugs and many others. I think it is now getting more attention because there has been a crescendo effect, almost a tripling of the number of drugs being followed that are in short supply over the last five years. There are hundreds of drugs in short supply, versus 20 or 30 in years past.
The reason? That’s a bit more difficult. The companies don’t have to announce the reason for a shortage, so we really don’t know the reason in more than half the cases. Sometimes it’s a manufacturing problem, meaning they’re having difficulty producing a sterile injectible, because that’s what most of the drugs in short supply are. There can be issues the drug precipitates, or a problem with the line. I understand one manufacturing plant was closed down by the FDA because they had a number of problems, and that creates a shortage because there are very few manufacturers making a given drug. If there’s two and one goes out of business for a while, that creates a shortage.It sounds like the bigger issue is having some sort of advance notice that you know this is going to happen, so you can make alternative treatment plans.
Well, now you’re on to the solution, but I want to make sure that another problem is highlighted. That is that there is not much profit to be made on these drugs, certainly the oncologics. If a company is having problems making the drug that would require retooling and expense to solve, and they’re not making much money on the drug, there’s not much incentive to fix the problem. Also, because of the limited profits, these companies may have a different drug they can make, with a better business plan, and so there’s nothing to stop them from just ceasing to make the drug, as a business decision. Given that, the solutions are variable depending on what the real problems are, but economics has to be considered a key factor. Regarding advance notification, companies are not required to notify the FDA they’re going to stop making a drug if it is not listed as a medically necessary drug. Admittedly, if the FDA has advance notice, they can do something preemptively to prevent a shortage. They can explore alternatives like importing a drug from a source outside the United States where the manufacturing is FDA approved, try to induce somebody else to make the drug, etc. The longer the lead time, the more clout the FDA might have. The penalties for not notifying the FDA, even if it’s a medically necessary drug, are not terrible, so there’s not much incentive for the companies to let people know. One issue that has been raised is that advance notification actually could exacerbate the problem, because if it’s known a shortage is going to happen, distributors might buy up supplies, and there would be hoarding of drugs both by the hospitals and larger users, as well as distributors.