Millions of Americans battling cancer are facing obstacles to recovery that have nothing to do with the disease’s toll on their bodies. According to a new study, national shortages of cancer drugs are threatening the health of the people who rely on them to stay alive.
According to the survey, presented at an oncology conference in Chicago on Monday, about 83 percent of cancer specialists have experienced a drug shortage at their clinics in the past six months. Of those doctors, 92 percent said the shortage had some effect on their patients’ care.
A little over a third of the doctors facing a shortage ended up switching their patients from a cheaper, generic version of that drug to a more expensive brand-name version. Considering the fact that cancer care is already exorbitantly expensive — Americans battling cancer are twice as likely to wind up bankrupt compared to those who don’t have the disease — that could represent a serious strain on those patients.
But cancer patients are facing much more than potential financial hardship. Thanks to the shortages, some cancer specialists can’t find the drugs their patients need at any price. When that happens, doctors are forced to make some painful choices. Nearly 80 percent reported that they switched patients to a different, and potentially less effective, chemotherapy regimen. Some have been forced to give cancers more time to spread further by delaying patients’ treatment or reducing their doses. And 37 percent of the study’s participants even had to choose between their patients, deciding which ones could receive life-saving medication and which ones would have to go without.
William Li, the executive director of a foundation that sponsors research into blood vessel growth, told USA Today that some hospitals are forced to hold lotteries to decide which patients will be able to receive the cancer drugs that are in short supply. “It baffles the mind that this is happening in a modern society,” Li said, pointing out that the FDA should do more to avert drug shortages.
Currently, drug manufacturers can alert the FDA when they suspect an impending shortage, and the federal agency can take steps to try to mitigate the effect on the market, like approving the same kind of drug from a different manufacturer. But so far, that hasn’t been enough to avert the situation. Largely due to manufacturing errors in drug-production facilities across the country, the U.S. faces limited supplies of everything from ADHD medications to painkillers — and cancer patients end up being hit the hardest.
Much of the blame may lie with powerful pharmaceutical companies. One of the co-authors of the new study, Keerthi Gogineni, noted that cancer doctors are concerned drug manufacturers may be prioritizing the most profitable medications over the most life-saving ones. “Some manufacturers have diverted existing production capacity from less profitable agents to more expensive agents,” Gogineni explained. Similarly, a group of over 100 doctors recently criticized Big Pharma for “causing harm to patients” by continuing to sell cancer drugs at unsustainably high prices.
By: Tara Culp-Ressler, Think Progress, June 3, 2013
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June 4, 2013
Posted by raemd95 |
Big Pharma, Health Care | Cancer Drugs, Cancer Patients, Chemotherapy, Drug Manufacturers, FDA, Pharmaceutical Companies, Public Health |
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Last year the Food and Drug Administration rescinded approval of the drug Avastin for treating breast cancer patients, prompting a firestorm of criticism. The decision was denounced by some politicians as health care rationing, and by breast cancer patients who feared that they would be deprived of a drug that they felt had helped them immensely.
But these criticisms ignore the facts: Avastin was rejected simply because it didn’t work as it was supposed to, and the F.D.A. should resist the aggressive campaign by Genentech, the drug’s maker, to get that ruling reconsidered at a hearing in late June.
Avastin has been on the market for seven years, and combined with other drugs it is effective in treating, but not curing, some colon, lung, kidney and brain cancers. It inhibits the development of new blood vessels and in so doing can starve a growing tumor.
Treating a breast cancer patient with Avastin costs about $90,000 a year, and Genentech could lose $500 million to $1 billion a year in revenue if the F.D.A. upholds the ban.
A clinical trial published in 2007 demonstrated that Avastin, when paired with the chemotherapy drug Taxol, halts the growth of metastatic breast cancer for about six months longer than chemotherapy alone. Genentech then asked the F.D.A. for approval of Avastin, combined with Taxol, for use against metastatic breast cancer.
This halt in tumor growth is known as progression-free survival. But delaying the worsening of cancer does not necessarily prolong life, and Avastin was not shown to lengthen patients’ overall survival time. So Genentech argued that the drug led not to longer life, but to improved quality of life.
In 2007, an F.D.A. advisory committee rejected the application, deciding that the toxic side effects of Avastin outweighed its ability to slow tumor growth. The F.D.A., however, overrode the committee and granted what is called accelerated approval, allowing Avastin to be used pending further study. The criteria for full approval was that Avastin not worsen overall survival and that the drug provide clinically meaningful progression-free survival.
To support its case Genentech submitted data from two additional clinical trials in which Avastin was paired with chemotherapy drugs other than Taxol. Like the first trial, neither showed a survival benefit. Both showed an improvement in progression-free survival, though this outcome was much less impressive than in the original study. In addition to seeking full approval for the Avastin-Taxol combination, Genentech also asked the F.D.A. to approve the use of Avastin with the drugs used in these follow-up studies.
Genentech presented progression-free survival as a surrogate for better quality of life, but the quality-of-life data were incomplete, sketchy and, in some cases, non-existent. The best that one Genentech spokesman could say was that “health-related quality of life was not worsened when Avastin was added.” Patients didn’t live longer, and they didn’t live better.
It was this lack of demonstrated clinical benefit, combined with the potentially severe side effects of the drug, that led the F.D.A. last year to reject the use of Avastin with Taxol or with the other chemotherapies for breast cancer.
In its appeal Genentech is changing its interpretation of its own data to pursue the case. Last year Genentech argued that the decrease in progression-free survival in its supplementary studies was not due to the pairing of Avastin with drugs other than Taxol. This year, however, in its brief supporting the appeal, Genentech argues that the degree of benefit may indeed vary with “the particular chemotherapy used with Avastin.” In other words, different chemotherapies suddenly do yield different results, with Taxol being superior. The same data now generate the opposite conclusion.
Perhaps more troubling is the resort to anecdote in the brief to the F.D.A. and in the news media. Oncologists recounted their successes, and patients who were doing well on Avastin argued for its continued approval. But anecdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.
Avastin will not disappear because of the F.D.A. decision. It remains available for treating other cancers, and research to find its appropriate role in breast cancer treatment continues. In the meantime, the F.D.A., which is expected to make its decision in September, needs to resist Genentech’s attempt to have it ignore scientific evidence.
Serious progress in the treatment of cancer will not be the result of polemics, lobbying or marketing. Genentech’s money and efforts would be better spent on research for more meaningful treatments for breast cancer.
By: Frederick C. Tucker, Jr., Oncologist and Op Ed Contributor, The New York Times Opinion Pages, May 24, 2011
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May 25, 2011
Posted by raemd95 |
Big Pharma, Capitalism, Consumers, Corporations, Government, Health Care, Health Care Costs, Health Reform, Pharmaceutical Companies, Politics, Public Health, Regulations, U.S. Chamber of Commerce, Women, Women's Health, Womens Rights | Avastin, Breast Cancer, Cancer, Cancer Drugs, Cancer Patients, Cancer Survival, Chemotherapy, FDA, Genentech, Health Care Rationing, Metastatic Cancer, Oncologists, Oncology, Patient Safety, Patients, Politicians, Quality of Life, Taxol |
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