Intravenous vitamin infusions go unregulated while sick patients go without

When he was readmitted to the hospital, the patient had been in severe pain for three months. He had been living in a nursing home for the past five months, waiting for a tear in his intestine to heal, and was entirely dependent on parenteral (intravenous) nutrition for nourishment. Typically, patients are fed this way when there are no means possible to use the intestine for nourishment. However, due to national drug shortages, the pharmacy responsible for mixing his parenteral nutrition was unable to provide any of the essential trace elements (zinc, copper, manganese, chromium, selenium). After two months he developed severe zinc deficiency and the skin on his hands and feet became severely inflamed, causing him great pain and placing him at risk for developing other complications.

{mosads}It is estimated that more than 50,000 people receive parenteral nutrition at home, and more than 350,000 people per year receive it during a hospital stay. Patients have been kept alive for decades using this highly exacting technique. The prescription, mixing and administration require advanced training and equipment to minimize complications, and these intravenous nutrients are considered the most complex prescription drug preparation available.

All of these nutrients, when given intravenously, are prescription drugs (as opposed to the vitamins we take by mouth). In the past five years, there has not been a single period of time that every component of this life-sustaining therapy has been available. Shortages have led to limiting and removing such important components as calcium, fat and vitamins. Ninety percent of hospitals reported shortages in nutrition-related products in 2011. Dozens of reports of significant nutrient deficiencies and deaths have been published, and a large portion of the most recent issue of the Journal of Parenteral and Enteral Nutrition has been dedicated to this severe and growing problem.

On the other hand, healthy people have for decades flocked to receive infusions of vitamins from practitioners claiming to treat everything from Alzheimer’s to weight loss. Not exactly actually claiming — their websites are extremely carefully worded to avoid directly making unfounded claims, since there is absolutely no proper scientific proof that their therapies have any benefit. But their wording is suggestive enough that the unaware would easily infer therapeutic benefit. Stories appear regularly about celebrities taking vitamin infusions. Now there is a new trendy group of practitioners in “health bars” you can visit to treat your hangover or fatigue. There are vitamin buses — just like Good Humor trucks — coming to your local grocery store, and practitioners making house calls for you to get access to vitamin infusions. They have cropped up in airports and in malls. There are even websites that purport to teach you how to create your own intravenous drip of nutrients like vitamin C. Please, do not try this at home. The risks, such as severe bloodstream infection and undissolved crystals clogging capillaries in your lung, are real and can be fatal.

It is very concerning that the shortages in medications and nutrients required for treating very sick patients continue unabated. Further, without regulation, as they continue to ply their unproven and potentially harmful wares to an unsuspecting public, these vitamin infusion practitioners may compete with patients who are truly need them for a dwindling supply of these nutrients to sustain life. We have even learned of patients dependent on parenteral nutrition going to one of these centers to receive needed vitamins, because they were not available to the reputable pharmacy that was mixing their parenteral nutrition. Without regulation, there is no way to know whether these infusions are prepared in a manner consistent with best safe practices.

Nutritional quackery refuses to die. Lydia Pinkham’s remedies have been on the market since 1875, and are still sold on the Internet to treat menstrual problems and infertility. Low carbohydrate diets are still being pushed despite 225 years of research that does not support their superiority. The supplement industry provides large contributions to the legislators protecting the deregulation of all things nutritional, and vitamin supplements, which have been proven harmful, continue to be promoted in the media.

The vitamin and supplement-using public take these substances for the pharmacological and medical benefits that they are touted to provide. Their regulation, and in particular the regulation of the practitioners providing these substances intravenously, should be equal to that of pharmaceuticals. Patients with real disease should have priority, over the neurotic and hungover, for access to these life-sustaining substances.

Seres is an associate professor of medicine at the Institute of Human Nutrition, director of the Nutrition Curriculum at Columbia University College of Physicians and Surgeons and a Public Voices Fellow with the Op-Ed Project. Chan is an associate professor of Pharmacy and Nutritional Sciences at the University of Washington. Guenter is senior director of Clinical Practice, Quality and Advocacy at the American Society for Parenteral and Enteral Nutrition. Teitelbaum is president of the American Society of Parenteral and Enteral Nutrition and professor of Pediatric Surgery at the University of Michigan.