I Approve My Tax Dollars to do that: Bring Back Tetracycline

Attending a conference on small animal dermatology yesterday, one of the veterinarians asked the speaker about what drug to use as a substitute for one that is currently unavailable. To my surprise, the unavailable drug was not some obscure, esoteric medication. It was tetracycline, one of the most common broad-spectrum antibiotics used in human and animal medicine. I was shocked. How can such a drug be unavailable?

The current drug shortage is not a new problem. Since 2007, the number of unavailable drugs has been on the rise, peaking at over 280 as of October 2012. It is unclear as to when the shortage will be resolved. 

Photo credit: http://online.wsj.com/article/SB10001424052748704680604576110613604195324.html

Tetracycline joins the list of over two hundred drugs currently unavailable; a crisis over two years in the making. The entire list of unavailable medications can be accessed here. For the most part, the drugs on the list aren’t your unusual, random, rarely prescribed medications: they are your cancer treatment drugs, nutritional aids, anesthesia drugs, and antibiotics (http://onpoint.wbur.org/2011/10/04/prescription-drugs). The FDA cites manufacturing and quality issues as the main cause of the shortage. These include regulatory violations such as incorrectly printed expiration dates on bottles and sterility issues during production, and shortage of raw materials required to make the drugs. Though companies are required to inform the FDA of an imminent shortage and the estimated duration of the shortage as part of the Food and Drug Safety and Innovation Act passed in July, the FDA cannot force them or other companies to manufacture the drug. (http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm). The shortage affects a large number of suppliers but the majority of the drugs on the list only have one or two sources of supply (http://www.imshealth.com/portal/site/ims/menuitem.edb2b81823f67dab41d84b903208c22a/?vgnextoid=a6fbcc0f68f73310VgnVCM100000ed152ca2RCRD&vgnextfmt=default&vgnextrefresh=1)

How drug shortages affect patient care. While some drugs can be replaced with near equally-effective substitutes, such as doxycycline for tetracycline, others cannot. Even in the case of replacing tetracycline with doxycycline, increased use of one antibiotic risks creating increased resistance to that particular antibiotic. The last thing we need to do is to create more antibiotic-resistance super bugs such as Merca. 

Photo credit: http://online.wsj.com/article/SB10001424052702304584404576442211187884744.html 

Despite what the FDA claims, the shortage stems from more than manufacturing and quality assurance problems. Like most other shortages, the current drug shortage has as much to do with business as production. As more drugs became available in cheaper generic versions, companies quit producing brand-name versions because they could not earn a profit turning out more expensive drugs that neither hospitals nor insurance companies would pay for. They then switched to the less readily prescribed drugs. The switch ensured protection of their business venture, as financially it made no sense for generic companies to take up production for smaller quantities. Shortages arise when the generic companies producing the drugs experience material shortages or are shut down by the FDA for production violations. No factories, no drugs  (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60414-0/fulltext).

Health care should not follow free-market policies, especially not when people’s lives are at stake (I refer specifically to the availability of cancer drugs). What my body needs should not be at the mercy of companies more interested in making a dollar than my health. It’s absolutely ridiculous to me that such basic drugs are inaccessible to the public. Congress should exercise increased authority over drug manufacturers, holding them to tougher, and more stringent and ethical standards. At least fifteen deaths have been reported as a direct result of the shortage (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60414-0/fulltext). Congress needs to do something. Medicine is not about money: it’s about getting better.

I approve my tax dollars to do that: bring back my tetracycline. 

Some of the more popular drugs currently unavailable and their uses. Uses range from nutritional supplements, such as electrolytes, to cancer treatments. How would you feel if you went to the hospital and were told you couldn't be treated because the drug was not available? This is why we need to improve and increase federal overnight of drug manufacturing. 

Photo credit: http://sfmedicalsociety.wordpress.com/2011/08/22/prescription-drug-shortages-forcing-physicians-and-pharmacists-to-scramble/