Start Giving Vitamin C to Sepsis Patients Now!

A patient receiving an IV

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’s Breakthrough

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.

Foolish Resistance

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.

 

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2 thoughts on “Start Giving Vitamin C to Sepsis Patients Now!”

  1. Thank you Lau­rie for your well rea­soned thoughts on this excit­ing break­thru. I have been read­ing about vit­a­min c as a adjunc­tive treat­ment for sep­sis for at least 6 years now. EVERY sin­gle study or paper calls for more study. Only one or two sug­ges­tions that it might be wor­thy of care­ful use until the results of the mul­ti­cen­ter tri­als con­firm its effi­ca­cy. I had even drawn up a list of poten­tial ingre­di­ents to acom­pa­ny the vite c. Thi­amine was 14 on my list of 22. Aspirin (anti­co­ag, anti-inflam­ma­to­ry), vite d (immunomod­u­la­tor often defi­cient in sep­sis pts), quercetin (reduce vas­cu­lar leak­age), and glycine(neuro calm­ing effect) would prob­a­bly have been my first fan­ta­sy ingre­di­ents. No need now. Answer seems to be here before the proof. Until harm can be proven, I say use the answer and let those capa­ble of run­ning the stud­ies and rais­ing the huge amounts of $ need­ed, get to work in the mean time. Because right now the weapons in the crit­i­cal care tool box are insuf­fi­cient for the task at hand. This prob­lem of sep­sis has an answer that has been extreme­ly dif­fi­cult to ascer­tain. The results of the Marik Pro­to­col bor­der on the amaz­ing which invites the skep­ti­cism born of many pre­vi­ous promis­ing implod­ing “cures”. How­ev­er this one goes right to the core of the prob­lem, fail­ure of cir­cu­la­tion sur­round­ing the organs. Cir­cu­la­to­ry sys­tem fail­ure is the first organ fail­ure in the sep­sis chain. All the MOF’s pro­ceed from there. Marik’s pro­to­col goes right to the heart of the prob­lem, that is why its results are so strik­ing, so dra­mat­ic.

    1. Of course, Marik’s pro­to­col needs fur­ther study. But ICU doc­tors should study it fur­ther by imple­ment­ing it right away and see­ing if their patients stop dying. They do not need to wait for the com­ple­tion of the kind of study only a Nazi would do: ran­dom­ly assign­ing peo­ple either to receive life-sav­ing treat­ment or to go with­out. There is no longer enough uncer­tain­ty about the val­ue of Marik’s pro­to­col to jus­ti­fy a place­bo arm.
      Some peo­ple have com­ment­ed that Marik’s treat­ment is “nat­ur­al.” It is not. It is nat­ur­al for human beings to get a fair­ly small dose of vit­a­min C from their food. We do not nat­u­ral­ly inject pure vit­a­min C direct­ly into our blood­stream.

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