It sounds almost too good to be true. Dr. Paul Marik, the Chief of Pulmonary and Critical Care Medicine at Eastern Virginia Medical School, in Norfolk, Virginia, has found that a cocktail of intravenous vitamin C and corticosteroids, along with a little bit of thiamine, may be a cure for sepsis, which is a major cause of death. (Sepsis killed Patty Duke and Muhammad Ali.) Many physicians are skeptical of Marik’s claim, for two reasons. First, they have heard a lot of nonsense about vitamin C over the years. Second, they have been trained to wait for the results of a double-blind randomized controlled trial before they make any change in how they practice medicine. As a result, they may be slow to adopt Marik’s protocol. But if they hesitate, they will miss the chance to save lives. Physicians have nothing to lose by trying the Marik’s protocol. Patients have everything to lose if their physician hesitates.
Saving the Lives of Sepsis Patients
Marik’s breakthrough came in January of 2016, as he struggled to save the life of a 48-year-old woman suffering from overwhelming sepsis. He had recently read that vitamin C might be a useful treatment for sepsis. He recalled that steroids, which are commonly used for treating sepsis, might work well in concert with vitamin C. So he ordered that the patient be given a combination of steroids and vitamin C intravenously. Within hours, she started to recover. Two days later, she was well enough to leave the intensive care unit. Then, Marik and his colleagues used the same treatment on two more patients who seemed destined to die of sepsis. Those patients also recovered. At that point, Marik and his team adopted the combination therapy as standard practice. They eventually added a small dose of thiamine to the protocol, because sepsis patients are also often deficient in thiamine. Since then, they have not seen a single patient die of sepsis. (However, some did die of the underlying disease that led to sepsis.)
Marik’s claims have been supported by an adequately powered clinical study. However, that study was retrospective. It compared 47 consecutive septic patients treated with his protocol to 47 septic patients who had been treated before his institution began using the protocol. Only 4 of the 47 patients treated with the vitamin C protocol died, as compared with 19 of the 47 patients in the control group (P<.001). Most importantly, none of the patients in the treatment group developed progressive organ failure. That finding suggests that the treatment is effective against the sepsis, in particular.
Sepsis Patients Need Vitamin C
Marik’s claim makes biological sense. Sepsis could actually be a form of scurvy, which is the disease that results from vitamin C deficiency. In 2012, Wilson and Wu explained how and why vitamin C could improve the function of tiny blood vessels in sepsis patients. The vitamin C would have to be given intravenously. That would be the only way to raise the vitamin C concentration to high enough levels. In 2015, Carr et al pointed out that patients with sepsis are known to have low vitamin C levels. In that article, the authors also explained that vitamin C is an important cofactor for the enzymes that are involved in the synthesis of norepinephrine and vasopressin, which are the hormones that help the body maintain blood pressure.
Several doctors have told me that they would refuse to use this treatment. But the objections that they give are foolish. Some of them insist that they will wait for a “proper” study to be done. But those doctors have never been involved in research, and they do not understand that such a study would be illegal. It would mean allowing patients to die, when you could have saved their lives. Some other doctors want to wait for the FDA to render an opinion on the use of vitamin C in sepsis. However, the FDA will never do that, because no pharmaceutical company is applying for permission to market vitamin C as a treatment for sepsis! Vitamin C is already on the market as a generic drug!
Don’t Wait for a Placebo-Controlled Trial!
Some doctors may quibble about the supposed “flaws” of the design of Marik’s study. They may insist on a prospective, randomized, placebo-controlled study before they adopt the vitamin C protocol. Yet the fanatical refusal to look at any other kind of evidence is an error in reasoning called methodolatry. The word methodolatry is a portmanteau of methodology and idolatry. David Gorsky explains the problem of methodolatry here.
Do not wait for a placebo-controlled trial of vitamin C for sepsis. No such study will ever be done, because no such study should ever be done. Doing such a study would violate a basic principle of medical research ethics! Researchers are not supposed to assign patients with a serious illness to different treatment arms unless there is real uncertainty about which of the treatments would be better. This principle is called clinical equipoise. Yet there is no real uncertainty about the value of vitamin C for sepsis. The probability that the results of the retrospective study were due to random chance is less than one in a thousand. Nor was there any reason to suspect that the differences in outcome were due to any confounding variables. Nor are there any serious safety concerns about adding vitamin C and some thiamine to the commonly used corticosteroid treatment for sepsis.
Regulatory agencies typically require drug companies to do double-blind, randomized controlled trials to support a new drug application. Yet there are some exceptions. For example, the Food and Drug Administration’s approval of lepirudin (Refludan®) for anticoagulation in patients with heparin-induced thrombocytopenia was based on a clinical trial that used historical controls. The FDA did not require the drug’s sponsor to assign patients to a placebo treatment that would have threatened life and limb.
Do Not Wait for the FDA!
One doctor have told me that he will wait for the Food and Drug Administration to render an opinion about the use of vitamin C for sepsis. Yet that doctor has clearly never worked in pharma, and he does not understand what the FDA is for. The FDA regulates drug marketing, not medical practice. The FDA decides what the drug companies can sell in the United States, and how they can sell it. Doctors can generally use the available products as they see fit, even for purposes that were not mentioned in the approved prescribing information. The FDA is not going to give any pharmaceutical company the permission to advertise their vitamin C product as a treatment for sepsis, because no drug company is going to go to the trouble and expense of submitting a new drug application (NDA) to get a new indication for a generic drug.
Use Vitamin C and Thiamine for Sepsis Now!
So we now know that vitamin C, which is a cheap, easily available product with a long history of safe use, is probably the key to the preventing people from dying of sepsis, which is a major cause of death. Adding vitamin C and thiamine to the standard steroid treatment for sepsis saves lives. The medical profession will be judged by how fast or how slowly it acts on this information.