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, started giving his sepsis patients some intravenous vitamin C and thiamine. As a result, his patients stopped dying of sepsis. Sepsis is a major cause of death. It killed Patty Duke and Muhammad Ali.
Is Sepsis Due to Vitamin Deficiency?
The pharmaceutical industry has been trying for years to find a drug to treat sepsis. Now, we know why they keep coming up empty-handed. Sepsis is the result of the body’s response to an infection. This response may cause the body to run out of vitamin C and thiamine (vitamin B1). The only way to treat a vitamin C deficiency is to give the patient vitamin C. The only way to treat a thiamine deficiency is to give the patient thiamine. The best way to deliver these vitamins in an emergency is to give them intravenously. Intravenous vitamin C and thiamine products are cheap. They are already in the hospital pharmacy. Doctors should start giving them to sepsis patients now.
Many Doctors Will Ignore This Finding
Unfortunately, many doctors will ignore Marik’s breakthrough because Marik did not do a placebo-controlled trial. Instead, he compared the patients who got the new treatment with the patients who had been treated before he started using the new treatment. At this point, it would be wrong (and even illegal) to give sepsis patients a placebo instead of Marik’s treatment. Doctors should just start using Marik’s treatment and see if the death rates go down.
Marik has been an expert on sepsis for a long time. However, his breakthrough came in January of 2016. He was struggling to save the life of a 48-year-old woman who had severe 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.
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 Clinical Study
To support his claims, Marik has published the results of a clinical study. However, the 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. In contrast, 19 of the 47 patients in the control group died. There is less than a 1:1000 probability of a difference this big happening by random chance. Note that none of the patients in the treatment group developed progressive organ failure. That fact suggests that Marik’s treatment is effective against the sepsis, in particular. (Some patients could still die of other effects of the problem that led to their sepsis.)
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. Those 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. Thus, 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 should ever be done. Such a study would violate a basic principle of medical research ethics! You cannot assign people to treatment that you know will be ineffective. You cannot do a randomized controlled trial of treatment for a serious disease unless nobody really knows which of the treatments would be better. This principle is called clinical equipoise.
No Reasonable Doubt
There is no real uncertainty about the value of vitamin C for sepsis:
- There is no reason to believe that the patients who got the vitamins were different from the patients who had been treated only a few months earlier.
- The odds that the results of the retrospective study were due to random chance are less than one in a thousand.
- Intravenous vitamin C and thiamine are cheap and have a long history of safe use.
You do not always have to do a placebo-controlled trial, even to get a drug approved by the FDA. For example, the clinical trials of lepirudin (Refludan®) did not use placebo controls. The drug was being used for treating a disease that rapidly leads to loss of life and limb. For this reason, the lepirudin-treated patients were compared to patients who had been treated before lepirudin became available. The FDA did not require the drug’s sponsor to risk patient’s lives by assigning then to a placebo treatment.
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. Clearly, he does not understand what the FDA does.
The FDA is responsible for deciding what drugs can be sold within the United States. It bases this decision on studies of how well the drug works, as well as on evidence of safety. Injectable forms of vitamin C and thiamine are already on the market. These products are highly effective for treating deficiencies of vitamin C and thiamine (which are common in sepsis patients). These products are also remarkably safe. So no doctor has to wait for the FDA to allow a drug company to start selling these products. These products are already in the hospital pharmacy. The doctor just has to order a nurse to give them to the patient.
The FDA also decides what pharmaceutical companies can say about their products. If you want to say that your product is good for treating sepsis, you would have to prove to the FDA that your drug really is effective and safe for treating sepsis. However, no drug company is going to apply to get a sepsis indication for a cheap generic drug.
The FDA Does Not Regulate Medical Practice
The FDA regulates drug companies. It does not regulate the practice of medicine. The FDA puts limits on what products are available to doctors, and on how those products can be marketed. However, the FDA does not tell doctors how to use the available products. The state governments do that.
European countries have agencies that make recommendations about how doctors should practice medicine. In England, the National Institute for Health and Care Excellence (NICE) makes recommendations about what treatments should be available through the National Health Service. However, NICE usually focuses on the use of new and expensive products, when the cost-effectiveness is not clear. Vitamin C and thiamine are old and cheap. The risk of using these products is practically nil, and the benefits can be huge. This is such an easy decision to make that there would be no need for NICE to run this analysis.
Use Vitamin C and Thiamine for Sepsis Now!
Vitamin C and thiamine are cheap, easily available products. They have a long history of safe use. We now know that they can be the key to preventing death from sepsis. Adding vitamin C and thiamine to the standard steroid treatment for sepsis saves lives. Doctors, you will be judged by how fast or how slowly you act on this information.