GWEN IFILL: Now, how a shortage of some key drugs are creating problems for patients.
NewsHour health correspondent Betty Ann Bowser has our report.
BETTY ANN BOWSER: This is what Bruce and Kelly Blair had been waiting to hear for six months.
WOMAN: The bone marrow shows that you are in complete remission. After all of the induction therapy, the consolidation, all the issues, you’re in remission. We’re done.
BRUCE BLAIR, civil engineer: Good. Good.
BETTY ANN BOWSER: Just after Christmas, 55-year-old civil engineer Bruce Blair was handed a potential death sentence: acute myeloid leukemia, an aggressive form of cancer that destroys healthy blood cells.
Normally, Blair’s doctors in suburban Washington, D.C., would have inundated his body with cytarabine, a low-cost generic chemotherapy drug that cures a high percentage of cases.
But for Blair, there was no cytarabine, because it was one of the more than 180 critical drugs in short supply all over the country.
Are we talking about drugs that literally create a life and death situation sometimes?
CAP. VALERIE JENSEN, Food and Drug Administration: Absolutely. That’s right.
BETTY ANN BOWSER: Cap. Valerie Jensen is the assistant director of the Food and Drug Administration’s office that tracks shortages.
Is this unprecedented?
CAP. VALERIE JENSEN: It is. When we look back at the last six years, since we have tracked shortages, we have not seen these levels. We have not seen anything near these levels.
BETTY ANN BOWSER: In June, the American Hospital Association surveyed its members and found 82 percent of patients who couldn’t get medications on the shortage list experienced delayed treatment. For those who were given a substitute, 69 percent got less effective treatment.
The pharmacists who practice in those hospitals are especially concerned about the situation.
Joseph Hill is legislative director of the American Society of Health-System Pharmacists.
JOSEPH HILL, American Society of Health-System Pharmacists: This is really approaching crisis levels from our members’ perspective. They are finding that they are having to scramble to find product, and there is certainly concern that care is going to be rationed.
BETTY ANN BOWSER: About 60 percent of all the critical drugs in short supply are generic sterile injectables like these. They come from the drug manufacturers in self-contained doses, ready to be injected.
They are mostly low-cost generics given in hospital settings. They are also critical drugs, ones used to keep patients in the intensive care unit alive, anti-cancer drugs for which there may be no substitute, and medications crucial for some surgeries.
Most of the other 40 percent on the shortage list are brand-name drugs still under U.S. government patents, for which there are no generic equivalents. And few of them are critical to patient care.
When Blair’s oncologist, Dr. Dipti Patel, was unable to get cytarabine, she came up with a substitute. But it was more toxic, took longer to administer, and didn’t have the same proven cure rate.
DR. DIPTI PATEL, Virginia Cancer Specialists: It really cripples our ability to treat properly. And we have to become creative of how to treat patients such as this, because, often, leukemia patients can’t wait for their treatments.
BETTY ANN BOWSER: Patel practices at Virginia Cancer Specialists in Fairfax, Va., part of the U.S. oncology network of physicians.
DR. DIPTI PATEL: Timing for acute leukemia in general is very critical. I mean, it is a very proliferative disease, meaning it rapidly divides, and often can change in terms of your white count and how you feel in your clinical course within days. So it is not something we watch and wait.
BETTY ANN BOWSER: Although there was no solid evidence-based medicine that showed the alternative treatment would work, Patel was confident. But there were still some scary moments.
BRUCE BLAIR: There was actually some concerns as to what’s going on.
BETTY ANN BOWSER: Whether it was working.
BRUCE BLAIR: Whether it was working. And actually the other concern that we were told is maybe the cancer is back. When you are going through this, that’s kind of the last thing that you actually want to hear, is that maybe the cancer is back. And it really — for that two-week period, it really kind of puts you a little bit on edge.
BETTY ANN BOWSER: Things might not have been so edgy for Blair if more drug companies were still making critical generic drugs. But as a number of them have undergone consolidation of their manufacturing lines, some have dropped out of the generic market altogether. And the FDA says there is something else driving the shortage: money.
CAP. VALERIE JENSEN: When we ask firms why they discontinue these drugs, the usual reason that we receive back is that these are not profitable drugs. So, as newer drugs come off patent, often, those are picked up by firms. And they want to make those drugs because they are more profitable. And these older sterile injectables can get discontinued for that reason.
BETTY ANN BOWSER: The drug industry’s chief trade association, PhRMA, declined the PBS NewsHour’s invitation for an on-camera interview.
However, the Generic Pharmaceutical Association’s Bob Billings said his members have no financial incentive to create a shortage.
BOB BILLINGS, Generic Pharmaceutical Association: I can’t fathom that. Our entire mission here is just to make sure that we provide and our members provide access. We last year, out of the four billion prescriptions dispensed in the U.S., three billion were generic. And we just continue to work on making sure that we have every drug that we manufacture accessible.
BETTY ANN BOWSER: Billings says some generic drug makers have trouble getting raw materials from overseas, where 80 percent of all ingredients come from today. And the FDA says there have been problems in the manufacturing process.
CAP. VALERIE JENSEN: We have seen quality issues that have been discovered on inspection. And that’s what has been occurring, as well as quality issues in general that have been discovered outside of — once the drug has already left the manufacturer and has reached hospitals. And that has been a major reason for shortages that we have seen.
BETTY ANN BOWSER: Exacerbating all of this is the gray market, where many hospitals have had to go to get critically needed drugs.
This is a market where unscrupulous suppliers hoard drugs in anticipation of a shortage, and, when it happens, they jack up the price. According to a recent survey done by Premier, a national information sharing service, the gray marketers have been asking hospitals to pay an average of 650 percent higher than the normal price for some oncology drugs and anesthesia products. And in most states, there is nothing illegal about this practice.
Drug maker Hospira, the company that produces roughly half of the cytarabine on the market, now makes its distributors sign contracts to only distribute to end users of its products, not other distributors. Federal legislation that would create an early warning system for FDA when shortages are about to occur is under consideration. And the Obama administration has been looking into setting up a national system to stockpile crucial drugs in short supply.
Meanwhile, Dr. Patel and others remain on the front line of a serious problem that has no end in sight.
DR. DIPTI PATEL: Frustrating, upsetting, exasperating. I — I — sometimes, it drives me absolutely up the wall.
I mean, when we are talking about diseases such as cancer, if you already have so many hurdles to conquer as a patient and as a family member and as a physician treating patients with cancer, and on top of that, this just outrageous external factor is just infuriating.
BETTY ANN BOWSER: Bruce and Kelly Blair look forward to each day now, knowing they can count themselves among the lucky ones. But they also wonder how many thousands of other patients are out there, also with cancer, who need a drug that could cure them, but is unavailable.