Around the country something is happening. Medical facilities are running out of drugs. The medications turning up in short supply are usually those for cancers. One in particular, Methotrexate most often used for Acute Lymphoblastic Leukemia is down to a couple of weeks supply for the nation, maybe less. The reason for the scarcity is not that the materials are becoming scarce, it’s because the drugs simply aren’t being made. Already medication distributors are raising the prices for the drugs, and of course, as prices rise more people have to go without.
Methotrexate is just one of some 267 prescription drugs whose shortages have proven life threatening. In response to FDA urgings, Congress is considering a bipartisan bill that puts safeguards in place for notifying drug companies of a need to up their production. Currently, there are no laws to force pharmaceutical companies to meet production standards, and many of them would rather focus on more lucrative medications new to the market.
As with organ donations, a gray market has developed as a result of the lapse in medications, and health care providers are being forced to reach to these distributors and their significantly higher prices. Drug shortages have been rising steadily in recent years. In 2004 only 58 shortages were reported. This number elevated to 211 in 2010, and this year adds another 56 for a total of 267.
The lack of available drugs are impacting patient care in hospitals, especially for cancer patients with a need for chemotherapy and pain control. The interruption in the flow of needed drugs has been blamed for fifteen deaths in the past year. Drug companies say they sympathize, but need to answer to investors as well as patient needs. While dollars for research for different cancer drugs has been on the rise, and significantly so, production facilities for older medications is waning. A producer of Methotrexate closed its production facilities after inspections showed serious concern for quality and safety in processing. There is no word from the company as to when production might be resumed.
In recent years the research for new medications has so diversified as to become dizzying, stretching the facilities such that the rate of progress in getting new drugs to market is also slowed. In the end, whicle it is profitable for pharmaceutical companies and the research arms of various facilities, it leaves patients with a current and desperate need out in the cold. Sadly, deaths are occuring in cancers for which there are cures, such as the childhood lukemia A.L.L. But without the needed drugs, the curable cancer is taking a death toll.
The Food and Drug Administration says the regulation is needed for drugs which become established components of successful therapies. It wants the ability to order drug manufacturers to ramp up production when signs of shortages appear. While at least being able to notify companies of am impending shortage is a good step they say, it isn’t enough and it’s patients who will pay the price in both the long and short run. Multiple Myeloma has not been left untouched. Supplies of Ondansetron, and anti-nausea drug commonly used to offset side effects of chemotherapy has been spotty, causing oncologists to slow or even hold up chemotherapy cycles because they’d be too hard on the patients.
Drug companies are also saying that increased regulation and the threat of price controls are responsible for shortages. Forcing the closure of facilities or slackening their production as companies try to maintain compliance with regulations is a cause for the shortages. Pricing limitations discourages investment, lso slowing down adding to or improving existing production facilities as they place their money in higher return investments.
The bottom line is that there are shortages and they’re increasing, driving up prices and reducing the number of patients able to benefit from the medications in short supply.