John Curtin, MD
Many contemporary issues in the US healthcare system affect clinicians in all areas of medicine: The Supreme Court hearing on the constitutionality of certain aspects of the Affordable Care Act, the development and makeup of accountable care organizations, and relationships with industry. Other issues, such as the current shortages of oncologic drugs, affect oncology specialists to a greater extent than they do other clinicians.
Some issues are even more specific to the field of gynecologic oncology, such as finding ways to improve survival and cure more patients with ovarian cancer, eradication of cervical cancer, and encouraging cooperation with other clinicians–including nonphysicians– who have a special interest in gynecologic cancers.
At the 2012 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, held in March in Austin, Texas, outgoing SGO president John Curtin, MD, director of Gynecologic Oncology, New York University Langone Medical Center in New York City, addressed all of the above-mentioned issues and more in a wide-ranging interview with Oncology & Biotech News
.OBTN: Shortages of oncologic drugs have made a lot of headlines recently. How have the shortages affected the field of gynecologic oncology?Dr. Curtin:
For our patients and for the members of SGO, the primary problem remains the availability of Doxil (liposomal doxorubicin). Our society has been taking a proactive approach to this problem, discussing the shortage with the manufacturer. Additionally, we have taken an interest in the fact that the FDA has allowed temporary importation of Lipodox, which apparently is an agent that has been around for awhile, but the manufacturer never sought generic equivalency. The FDA felt it needed to allow this agent to come into the country, given that it doesn’t look like there is going to be any Doxil available for awhile.
We know that ovarian cancer patients aren’t the only patients who benefit from Doxil. I believe it is approved for multiple myeloma in combination with another agent. It is approved for Kaposi’s sarcoma. But it seems like it is a primary drug for ovarian cancer. I have seen estimates that 7000 women a year are being treated with Doxil.
The shortage of Doxil is a little different from shortages of other drugs, in that some of those generic drugs are in short supply because there isn’t a big interest among pharmaceutical manufacturers to make them, because there is such a close margin between cost and revenue on them. With Doxil, the company that had licensed it contracted with another manufacturing plant for production. That plant had sort of a poor infrastructure, and it didn’t seem like they were keeping up. Finally, the situation got to the point that the FDA gave them a very critical review, and, according to my understanding, the manufacturing plant voluntarily shut down before the FDA could close it. I have read the FDA report, and the issues with the plant were related to manufacturing processes, quality control–a lot of it was about just good manufacturing practice.
The toughest thing for physicians has been trying to explain to patients why this very active drug–which is relatively easy to give to patients, who have a relatively good quality of life while on it, and that works in a substantial proportion of patients–all of a sudden is not available. It became unavailable in July 2011, and we keep hearing different timelines for when it’s going to come back.Physicians who might not be familiar with this issue might look at it and say, “What’s special about liposomal doxorubicin? Why can’t you just use the old Adriamycin or one of its generics?”
The big difference is toxicity. Having treated patients with doxorubicin in the past, I know the biggest problem is that you’re limited to about eight cycles, and then you start to get unacceptably high rates of cardiac toxicity. When you give doxorubicin, you have to be very careful because it’s a desiccant and can cause tissue injury. A lot of patients require central lines. With liposomal doxorubicin, you avoid a lot of that. There are still some patients who develop cardiac toxicity, but the number is very low. Most patients tolerate the drug quite well. It does seem to be something about the formulation. By putting the doxorubicin into liposomes–and there are a lot of theories about why it works–it appears to deliver a higher concentration of doxorubicin to the tumor and minimize the toxicity to normal tissue, which is an ideal way to target a drug like doxorubicin.Have you heard when production of liposomal doxorubicin might resume in the United States?
I’ve heard two things. I’ve heard that production will start up again in July 2012, and I’ve heard that it will resume at the end of 2012. The problem is that we have heard several different timelines that have passed, and there’s no drug produced, so it’s frustrating, and I no longer expect the dates that I hear to be accurate.