Ebola Treatment Protocol Questioned

             “THERE IS NO TREATMENT, THERE IS NO CURE”…well, that is not entirely true.

            The heroic organization Medecins Sans Frontieres (MSF) and the physicians at other Ebola treatment units (ETUs) in West Africa provide a minimal form of treatment called “supportive care” for patients with Ebola virus disease (EVD). This includes keeping patients hydrated with water containing electrolytes, giving antibiotic drugs to help prevent secondary infections, painkillers and antimalarial drugs. This increases an Ebola patient’s chance of survival from only 10% in the absence of such care, to an average of 45%. But basic supportive care does not include any drug therapy targeted directly at the virus itself – no antiviral medication.  

            Two days after I arrived in Monrovia, Liberia from South Africa for the second time during the 2014 Ebola crisis, I attended the “Treatment Protocol Review” meeting at the Corina Hotel on Tuesday, November 11^th.

            Approximately fifty health professionals attended this Ebola protocol review. They represented various government and non-government organizations including the National Institutes of Health (NIH), the Center for Disease Control (CDC), the US Agency for International Development (USAID), the US Army, the Food and Drug Administration (FDA), the US Public Health Service, the World Health Organization (WHO) and the Liberian Ministry of Health (MoH). About half those attending were from the United States and approximately ten percent were Liberian. The remainder were Africans or Europeans representing various international health NGOs. Dr Moses Massaquoi, country director for the Clinton Health Access Initiative and head of Ebola case management at the Liberian MoH co-chaired the meeting, along with a young Indian doctor from the NIH.

            The group met briefly as a whole, then divided into five working groups to discuss their assigned topics. The five working groups were: 1) clinical guidelines (general and co-morbidity) 2) special populations (children, pregnant women, breastfeeding, etc.) 3) nutrition 4) psychosocial, and 5) experimental and non-traditional therapies. After morning and afternoon sessions, the groups merged to listen to and comment on the various working group reports.

As Dr Massaquoi expected, I joined group five expecting to discuss experimental and non-traditional therapies. There were nine members in our group, medical and health bureaucrats, most with MD and PhD degrees that I lacked. Given its designation I thought group five would examine what possible therapies should be considered to be tested against Ebola and the pros and cons of those potential treatments. We could prioritize what therapies should be fast tracked for testing and eliminate suggestions for some proposed remedies like nano-silver or herbal concoctions. Those had little scientific merit and no probability that they would be effective against a virus as aggressive as Ebola. Since the doctors I had been working with at the Ministry of Health had already conducted a successful trial using the selenium I had brought them at their request on my first trip from South Africa, naturally I thought I might be given five minutes to make a brief presentation. Our informal clinical trial conducted at ELWA Hospital, Monrovia in August had demonstrated selenium’s ability to reduce mortality by almost 54% from current levels, even using a suboptimal dose.

Surprisingly, in the seven hour meeting, no one ever even mentioned discussing various potential therapies for Ebola. Instead, the only subject group five discussed was how to regulate and restrict testing and how to stop the use of whatever was currently being tested or used against Ebola that was not already included in the standard protocol. It did not matter how successful the results that had been obtained may have been. Group five recommended that all current testing of experimental therapies should be stopped as soon as possible. Thus, no medication should be given at any ETU after December 1 unless it was already an approved part of the current treatment protocol as of the date of the Corina protocol meeting. As someone suggested. that would be, “under penalty of the law” – even though the assembled group had no legal standing in Liberia. The group decided that any medication must undergo protocol approval before it is tested. That sounded reasonable, although it would make it much more difficult to conduct ad hoc informal trials by anyone lacking major financial backing. According to these recommendations, any ETU that gave selenium or lamivudine or anything else not included in the current protocol to patients after the first of December, those doctors should be subject to arrest. This allowed all therapies that were already part of the established treatment protocol to be used even though none of them had previously undergone controlled clinical trials against Ebola. It was clear that selenium and the anti-HIV drug lamivudine were the targets of this meeting because they were the only two therapies listed on the power-point slide that had been prepared prior to the meeting. The Treatment Protocol Review was obviously a formality to cement the door shut on the use of the only two therapies that had shown significant benefit to patients in the epidemic so far.   

            As the group five discussion progressed the young officer representing the US military seemed particularly enthusiastic in coming up with new restrictions to testing potential therapies. In his notebook he quickly drew up a list of at least five different ways to restrict research. Clearly he had prepared for this meeting. The officer even suggested that nothing should be tested in a clinical trial unless it had already been analyzed in the test tube and had shown anti-viral activity against Ebola. This would make it almost impossible to test anything first in Liberia. It would also eliminate the possibility of trying immunologically based mechanisms to treat EVD. Perhaps that officer had been working on the $147 million program the Army had invested in to develop Ebola medicines and wanted to protect that drug’s exclusivity. Regardless of the newly proposed requirements, ironically none of the “supportive care” therapies that were currently being used to treat Ebola had undergone clinical testing or rigorous analysis against EVD. According to the recommendations of group five, these therapies were all now exempt. The fix was in. The rules had changed.

            As the discussion dragged on it was easy to see the deck was being stacked against any novel intelligent medical innovation during this crisis.  Although I distributed scientific journal extracts about selenium and hemorrhagic fever virus diseases to the other eight group members, I never demanded to present my information because that seemed the opposite of everyone else’s agenda. I spoke up to make points several times but nothing I could say or present would have influenced a meeting intent on shutting down a more open process of investigating potential treatments and conducting informal research on EVD.  Sitting on the opposite side of the group circle, the FDA representative glared intensely at me as if I were the real enemy, not the virus. Although I had handed him the scientific information about selenium and its historic success in treating hemorrhagic fever viruses, he was the only person who left the hand-outs on the table, refusing to even acknowledge them. Closed minds need no more information – scientific or otherwise    

            Although the issue was not raised in this meeting, another foreign doctor in Liberia had suggested that selenium should not be used on Ebola patients unless or until its efficacy against Ebola had been reported in a peer reviewed medical journal. In this deadly crisis situation that was like putting the cart before the horse. Even if a clinical trial of selenium was fully funded and showed great success, this stipulation would delay its use for months. His suggestion disregarded the fact that selenium’s benefits against hemorrhagic fever disease had already been published in peer reviewed medical journals. The articles included reports that selenium had been shown to be effective in reducing mortality rates in both Marburg and Hantan hemorrhagic fever epidemics by approximately 60%. None of the drugs being used to treat Ebola had proved as effective as that. So this meeting had been called to establish a double standard. The Corina Hotel protocol review revealed that behind the scenes there was a full-scale effort to immediately stop Liberia from independently testing anything that might save the lives of Liberians infected by this disease. Accepting that agenda would slow down progress in finding effective treatments for EVD since it would limit research to investigating only new experimental drugs for the benefit of the pharmaceutical industry. Who would fund a trial of an inexpensive medication like selenium with no profit motive as an incentive? Even if fast tracked, new experimental drug investigation would take months, even years before effective therapies could slog through the lengthy process of testing and approval, and then be manufactured in the quantities needed.                     

              Logically, one must question why international “experts” are treating a viral disease with antibiotics instead of trying dugs with proven antiviral activity. All Ebola patients were being given broad spectrum antibiotics to prevent secondary bacterial infections. Yet none of them were being given antiviral drugs to try to slow down the virus that was causing the problem. Doctors were treating symptoms and trying to prevent potential infections but not attacking the cause or the mechanisms of the disease. If this were a newly emerging bacterial disease, doctors would immediately try a number of existing anti-bacterial drugs to see if any might work. Then why would international health authorities apparently refuse to try, even block testing existing anti-viral medications against EVD? Just like in HIV/Aids, Ebola infects and attacks the immune system causing immune deficiency leading to secondary bacterial infections that need to be controlled with antibiotics. But that is not an excuse for not attempting to attack the cause of this disease, the virus itself. Testing the arsenal of over two dozen antiviral drugs that are currently sitting on pharmacy shelves might quickly uncover several that would be more or less effective. Most of the instant pop-up experts who had descended on West Africa and the Cornia Hotel protocol review meeting were not Ebola experts at all. Most were not even acquainted with the underlying scientific mechanisms of the disease.

Dr Armand Sprecher heads MSF’s heroic efforts against Ebola in West Africa. No organization has worked more diligently and valiantly against this epidemic than Medecins Sans Frontieres. Dr Sprecher did not attend the Corina meeting. However when I talked with him previously in August at the Ministry of Health he told me he had been fighting Ebola outbreaks for fifteen years but was not aware that anything could treat Ebola. I was amazed he did not know about selenium’s effect against hemorrhagic fever diseases.

            As an Aids researcher my analysis of Ebola virus disease comes from a different historic perspective. I had twenty-five years experience researching HIV disease and fifteen researching selenium, reviewing a thousand medical journal articles copied from the UCLA and USC medical school libraries in Los Angeles. I have spent a dozen years in Africa selling selenium to medical clinics and pharmacies and talking with doctors and pharmacists about the results they observed in their patients. I designed several HIV clinical trial protocols for doctors to implement in Africa and have attended over twenty international Aids conferences on five continents. During those years I came across several medical journal articles that reported that 2.0 mg of selenium in the form of sodium selenite could successfully treat viral hemorrhagic fever outbreaks. Each time, this therapy resulted in 60% reductions in mortality. However if a medical paradigm purports to be true and it is repeatedly drilled it into doctors’ heads that “there is no treatment and there is no cure for Ebola”, this becomes the accepted dogma. Most physicians close the book on even the possibility of testing potentially beneficial existing treatments.

Dr Jerry Brown at ELWA Hospital who was named “person of the year” on the cover of Time magazine for 2014 tested the selenium tablets I brought to the Ministry of Health in early August 2014. Although he used a lower dose than I had recommended – 1.2 mg instead of 2.0 mg - he demonstrated a 54.5% increase in survival rates - from a 44% survival rate just prior to providing selenium to 68% with the new tablets. . Still, MSF refused to use selenium supplements on their patients. Their static treatment paradigm could not be reconciled with the fact that selenium actually works and saves lives of Ebola victims – a lot of lives. Paralyzed by the repeated medical mantra that nothing can possibly work against Ebola, their minds were closed, much to the detriment of their suffering patients. The Corina Hotel treatment protocol review was designed to keep them all closed by eliminating the possibility of innovative approaches to treatment.     

            Selenium works against Ebola through multiple immunological mechanisms. Ibuprofen, aspirin and the aspirin-derivative drug asacol (5-ASA) also work as broad spectrum antiviral medications through a single mechanism. These non-steroidal anti-inflammatory drugs (NSAIDs) reduce viral replication in the nucleus of cells by inhibiting the cellular protein NF-kB (nuclear factor-kappa binding). Almost all viruses utilize this critical human protein, called a replication factor, to stimulate their own reproduction. Therefore NF-kB inhibitor drugs (NF-kBIs) work as broad spectrum anti-viral agents. The medical profession prefers to ignore this well-established science because it conflicts with the maximum profit motivation of the pharmaceutical industry. Their rationale is that if you do not need a prescription for a medication, then we won’t tell you about it. Most physicians are not familiar with NF-kappaB inhibitors, or the immunological effects of selenium, because this is not taught in medical school.

After the protocol review meeting adjourned, the NIH co-chair of the meeting and I briefly discussed NF-kappaB. He indicated he either did not know or refused to acknowledge that NF-kB stimulates viral replication nor that NF-kB inhibitors would reduce viral replication. He asked me if I knew that NF-kB was in the human cell, the most basic fact anyone could know about it. In fact during the 1990s I read more than one hundred scientific papers on the newly prominent NF-kB protein. Nobel laureate Dr David Baltimore discovered this central actor in cellular and immune function – and viral replication - in 1986. As an intellectual exercise in the late-1990s I wrote an eight page scientific paper on NF-kB with over sixty medical journal references. The fact that NF-kB inhibitors are not used against Ebola and HIV is tragic. Health suffers and people die unnecessarily. While NF-kB inhibitors are certainly not the strongest class of antiviral drugs, they do reduce both viral replication and the impact of most viral diseases.

            What the NIH, the WHO and others either do not understand or acknowledge – that NF-KB inhibitors like aspirin/asacol, ibuprofen and selenium are broad spectrum antivirals - hurts people with Ebola as well as those living with HIV. Refusing to even test proven ways to reduce viral replication and reduce hemorrhagic fever mortality threatens not only West Africa, but potentially the entire world. While NF-kappaB inhibitors like aspirin and ibuprofen hold promise in treating Ebola that is no guarantee they will be highly effective. They need to be tested to determine their exact level of efficacy. Selenium has already been tested, retested, and found to be moderately to highly effective against hemorrhagic fever. In August 2014 it was tested against the specific strain of Ebola in this epidemic, Ebola-Zaire. In the past it has worked against other hemorrhagic fever viruses every time, providing a 50% or greater reduction in mortality when the correct dosage was used. Selenium supplementation hits at the very essence of this disease, the depletion of the immune protective element selenium by the Ebola virus. Selenium supplements work via multiple mechanisms reducing symptoms, as an antiviral, and by helping protect the immune system from the onslaught of Ebola. Other NF-kB inhibitors like NSAIDs are beneficial against both the virus and some of its symptoms. But no NSAID packs the powerful punch of selenium.    

            At the protocol review meeting the nutrition committee also did its best to supress the use of selenium. Its report suggested no one with Ebola should receive more than the RDA – the recommended minimum daily allowance of selenium – 60 mcg. That RDA for selenium is based on the minimum amount required at the cellular level to produce adequate glutathione peroxidase, the universal antioxidant that helps keep every cell in the body healthy. But 60 mcg is the minimum needed for a normal healthy person. The average American diet contains approximately 150 mcg selenium a day. However a sick person needs much more than that since viral and bacterial infections rapidly deplete selenium levels in the body. Selenium supplements benefit patients because just like most cells in nature, bacteria and most viruses need selenium in order to exist, so they steal it from the body. Microorganisms also attack the body’s selenium supply as a way to weaken the body’s immune defences against them. The nutrition committee’s recommendation reflected a great ignorance of the fundamental mechanisms of EVD. They were merely echoing the predetermined but unspoken agenda of the meeting – to shut selenium and lamivudine down.

 Many diets in the world are low in selenium. Some Scandinavian countries supplement selenium into their agricultural soil due to its anti-cancer properties. The average Liberian diet is almost certainly selenium deficient. In Zambia, a country with a similar diet, 50% of the population does not receive the minimum RDA of selenium. While the selenium poor diet predisposed Liberian patients towards negative outcomes, selenium rich diets contributed to better outcomes for the American doctors who were infected.

            Another disturbing thing brought up at the protocol meeting was that 100% of Ebola patients are given anti-malarial drugs. Have antimalarial drugs been tested in controlled clinical trials to see if they are beneficial in Ebola infection? The science suggests these drugs may be dangerous in this circumstance. During the group five discussion the doctor from Sweden erupted when I suggested that not every Ebola patient should be given antimalarial treatments. He questioned whether I knew that everyone in the region has malaria. I did know malaria was endemic and chronic, but people only suffer active malaria one or two weeks a year and not every year at that. On the other hand, apparently the doctor was completely unaware that the immunological action of antimalarial drugs directly increases viral replication and could contribute to EVD progression and death.   

            Antimalarial drugs attack malaria parasites by massively increasing oxidation in the red blood cells malaria infects. This massive increase in oxidation kills the malaria parasite but it increases the release of NF-kB by orders of magnitude. NF-kB is the primary stimulant to viral replication in the nucleus of cells where viral particles are produced. [To understand this better read my peer reviewed, published scientific paper found on this website, “Taking the HIV Factory Tour”.] Theoretically, anti-malarial drugs should significantly increase Ebola replication, putting patients at greater risk. While anti-malarial drugs cause hyper-oxidation to kill malaria parasites, the Ebola virus also causes hyper-oxidation (peroxidation) that damages blood vessels. That is what eventually causes hemorrhaging in about one percent of cases in the terminal stage of EVD. Thus using antimalarial drugs on 100% of Ebola patients is most likely doing much more harm than good. Should the use of antimalarial drugs be banned from Ebola treatment until they have undergone controlled trials? That would be a wise precaution. At a minimum EVD patients should be tested for malaria before they are given antimalarial drugs and only patients with active malaria should be given them. Once again this shows the newly minted Ebola protocol “experts” have it wrong and often are not even asking the right questions.   

Antimalarial drugs certainly present a much greater danger to Ebola patients than selenium tablets. That raises the question of what other drugs in the current treatment protocol might also be dangerous to patients since none of them have undergone clinical trials against Ebola. Because anti-malarial drugs increase viral replication, it should be a high priority to quickly conduct a controlled clinical trial to determine whether their blanket use is helping or hurting EVD patients. The science suggests they are hurting patients, leading to a greater death toll than if they were not used at all.

            Another questionable choice in the current Ebola treatment protocol is the use of acetaminophen (Panadol, Tylanol) as the pain killer of choice. Some doctors have laughed or cringed when I mentioned aspirin as a potential treatment for Ebola. The representative of the WHO in the meeting attacked me for mentioning aspirin and asked if I knew anything about it. I did not respond that I had read over two hundred medical journal articles on aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) plus two books on the subject. I am the leading expert in the world on how aspirin and NSAIDs affects HIV disease and have designed and had clinical trials conducted on aspirin and HIV. I have used it personally every day since 1990 as part of the combination to treat my HIV infection.

According to a recent report in the New England Journal of Medicine, only about one percent of those infected in the current Ebola epidemic exhibit the symptom of hemorrhage. Then why do we refer to this as a “hemorrhagic” fever disease? That misnomer distorts the medical community’s understanding of the physiological processes underlying this illness as well as its approach to treating it. EVD might more accurately be renamed “blood clot fever” disease. Massive blood clotting, technically referred to as disseminated intravascular coagulation (DIC), is a distinctive physiological hallmark of this disease. However this clotting symptom is not apparent to the physician’s eye. The hemorrhagic fever designation is oxymoronic. It contributes to the medical community’s confusion as to how to treat EVD. One BBC news report filmed a doctor condemning a pile of medicine boxes that contained NSAID drugs. The doctor claimed they would be dangerous for a person who was hemorrhaging. That is true. But EVD is not fundamentally or even primarily a hemorrhagic disease. It is a disease that primarily exhibits blood clotting. Paradoxically, the drugs the physician on the BBC was condemning are the very drugs that should be helpful. This misnamed viral disease is confusing. It certainly has confounded the budding neo-experts and most of the doctors that are trying to treat it.      

            The woman representing the WHO in group five asked, “How do we know selenium is safe for Ebola patients?” In fact, selenium supplement tablets are 100% safe for almost any person to take. There are no negative side effects. One person in a hundred is just slightly allergic and one in a thousand is truly allergic. But the overall side effect profile is low compared to almost any other drug. In general, selenium tablets are safer than water, at least un-purified water, and certainly safer than almost any drug. They are not only safe but also beneficial for pregnant or breastfeeding women, and at lower doses for infants or children. Selenium supplements are not contraindicated to - do not conflict with - any other drug. Thus they can be used in conjunction with any other medical regimen. Not a single death has been attributed to an overdose or misuse of selenium supplements in over fifty years on the market. According to toxicology standards, a fatal dose of selenium consists of approximately 3.5 grams. That is more than 1,700 full strength selenium tablets. Medical journals report that high dose selenium therapy – about 2mg - can reduce death from sepsis by 27% while low levels of bodily selenium increase the chance of death from sepsis by 300%.  As a terminal disease condition, sepsis or “blood poisoning” is similar in most respects to the critical phase of EVD. The symptoms are basically the same. 

Starting with the early symptomatic stages of EVD, it is selenium depletion by the virus that causes the primary problem of DIC blood clotting. Hemorrhaging is only rarely a very late stage manifestation. Bleeding is caused by a combination of the hyper-oxidative damage to the blood vessels and massive blood clotting – both caused by the sudden, dramatic loss of selenium due to rapid viral replication. Selenium, aspirin and other NSAIDs help prevent both of those effects – clotting and blood vessel damage.

            NSAIDs have one major advantage compared to acetaminophen. While both NSAIDs and acetaminophen reduce fever, pain and inflammation, only NSAIDs also reduce viral replication by inhibiting NF-kB. Doctors could use NSAIDs in combination with acetaminophen since they work by different immunological pathways and have different side effects. In 1990 Dr Donald Kotler of Columbia University showed that asacol significantly reduces HIV replication by approximately 65%. The drug Asacol is exactly like aspirin except it does not prevent platelet aggregation - blood clotting. As an NF-kB inhibitor it will also reduce Ebola virus replication rates below untreated levels. Ibuprofen is even stronger than aspirin/asacol in all these effects.

Oddly enough, at the Corina meeting the nutritional committee came back with a report that advised against the “overuse” of both pro-oxidants like iron, and antioxidants like selenium. They should have decided one way or the other. It cannot be both. EVD is a disease of hyper - too much - oxidation. Clearly, the pop-up experts demonstrate limited knowledge of the underlying virological and immunological mechanisms involved in EVD and none of these issues or medical facts were discussed during the meeting. Obviously antioxidants that reduce viral replication and vascular damage are preferable to pro-oxidants that do the opposite. These newly minted experts appeared so caught up in an unrecognizably oxymoronic paradigm they no longer knew what to recommend.

            At the conclusion of the protocol review the psychosocial committee and many others repeatedly raised the issue of Ebola patients suffering from severe depression, hostility and confusion. They wondered how to address this problem. No one seemed to have a solution. By that time I just kept silent. I had said enough. Depression, hostility and confusion are all hallmarks of low bodily selenium. According to the 2000 review article titled “The importance of selenium to human health” by Margaret P. Rayman in The Lancet medical journal, “low selenium status was associated with a significantly greater incidence of depression and other negative mood states such as anxiety, confusion and hostility.” Unsuprisingly, this serves to highlight the fact that EVD and most of its symptoms are caused by rapid depletion of selenium by the virus – the same process observed in late stage Aids.

            Another issue in EVD is the involvement of the liver and kidneys. Any dietician knows one of the best sources of selenium in the diet is liver and kidney meat. The liver and kidneys are key organs in the immune system. Selenium is concentrated in the immune white blood cells as well as the various organs of the immune system because selenium is the keystone element of immunity. The reason the kidneys and liver basically “melt away” in late stage EVD is because they are where selenium is most highly concentrated in the body. The virus attacks them in order to gain the selenium it needs to replicate at such a ferocious pace. The Ebola virus genetically encodes an unusually large number of selenium molecules and because it replicates at such an extraordinary rate it specifically attacks and ravages high selenium content organs. One might speculate whether the virus “feeds” on selenium supplements. To the contrary, selenium supplements reduce viral replication, reduce oxidative stress and reduce damage to blood vessels. They boost the immune system’s ability to fight Ebola, in part by increasing CD4 count – the white blood cells that control immune function. Selenium supplements replace the selenium that the virus steals and the immune system needs to work.

            This raises another question regarding the current protocol. Acetaminophen (Panadol) can damage the liver. Liver damage is one of the most serious and frequent negative side effects of this drug. High doses of acetaminophen cause over half of all acute liver failures and some people are more genetically susceptible to this reaction. It is highly questionable why acetaminophen is the drug of choice to treat a disease that has destruction of the liver as one of its most deadly symptoms. Thus the standard accepted EVD protocol may have gotten it grossly wrong again. Or at the very minimum it has not been clinically proven right. For a number of reasons ibuprofen could be preferable to acetaminophen in treating EVD. Ibuprofen should be clinically compared to acetaminophen in a clinical trial of Ebola patients. Doctors and health bureaucrats should stop making unquestioning mistakes that have not been subject to clinical trials. These protocol questions urgently need to be clinically tested so we do not continue making these same mistakes in future epidemics. It would be quick and easy to do so.    

            In the world of biology, genetics is destiny. It makes us who we are. It determines how viruses act. Dr Ethan Will Taylor of the University of North Carolina was the first to genetically sequence the Ebola virus. He discovered how many selenoproteins the virus genetically encodes and how many selenium atoms the virus requires every time it replicates. He explained that Ebola causes “a more dramatic selenium depletion in a matter of days than HIV infection can accomplish in ten years.” The HIV and Ebola viruses are similar in many respects. They both attack the immune system, cause oxidative stress, immune deficiency, and finally immune system collapse. They both increase NF-kB to stimulate their own reproduction, and they both deplete the body’s selenium supply. They are different in that HIV is a lentivirus – a “slow” virus – and Ebola a filovirus, the most lethal of more than a dozen known hemorrhagic fever viruses. Ebola-Zaire is a very “fast” virus indeed. It kills within two to three weeks of infection. Like most viruses, both HIV and Ebola-Zaire genetically encode selenium, but because Ebola encodes so much selenium and replicates so rapidly, it drains selenium from the body three hundred times faster than HIV. Depleting the body’s store of selenium is at the core of both how HIV causes Aids and how Ebola causes death from EVD.                                                                        

            At the Corina Hotel meeting I asked the co-chair representing the NIH about the need to test the approximately twenty-five existing approved anti-viral drugs against Ebola. He claimed the NIH had already conducted in vitro test tube trials on all those drugs and none of them showed antiviral activity against Ebola-Zaire. Somehow I did not completely believe him because if that is true, they must not have tested selenium, NSAID drugs or lamivudine. A month after I spoke to the NIH co-chair of the Corina protocol meeting the Journal of Emerging Microbes and Infections reported that researchers had found fifty-three different existing drugs that show some activity against Ebola in the test tube. Had the NIH somehow missed all of those? Thirty years ago Nancy Reagan made a similar statement when she told the American public that they were “testing everything they can” against HIV. Again “everything” apparently did not include selenium, aspirin, asacol or other NSAIDS. At least they failed to inform people with HIV of the benefits if they did. So two dozen antiviral drugs that just might work, or should at least be tested, remain on the shelf untested against Ebola. The treatment protocol review meeting at the Corina Hotel was designed to make sure they will be blocked from testing or at the very minimum significantly delay their testing. Testing them would be cheap, safe and quick – a matter of weeks. But the Corina meeting put an end to that. Using any of them, on an informal trial basis, supposedly was banned by this meeting. That begs the question about the antiviral drug used to treat HIV, lamivudine (3Tc).

            In September 2014 Liberian Dr Gabriel Logan who oversees an ETU at Tubmanburg Hospital treated fifteen Ebola patients with the first generation, not terribly effective HIV antiretroviral drug (ARV) lamivudine. Only two of his patients died – an 86.7% survival rate. Following the Corina protocol meeting I met with the chief medical officer of Liberia, Dr Bernice Dahn and inquired about this. I expressed my suspicion that perhaps all these patients had not been confirmed Ebola patients. She made a quick cell-phone call and confirmed they had been positive for Ebola. If this is true, it would be remarkable and would tend to contradict the assertion by the NIH co-chair of the Corina meeting who claimed that all these ARVs and other antiviral drugs had been tested in vitro against the virus and found wanting. It is curious that after the success with lamivudine was reported on the BBC, someone from the WHO in Geneva, Switzerland phoned the Liberian regulatory authority and demanded to know where Dr Logan had gotten lamivudine. After all, lamivudine is one of the oldest, most common ARV drugs, found in almost every government clinic in Sub-Saharan Africa. In advanced HIV therapeutics it has been replaced by a fourth generation three-drug combination ARV that includes lamivudine called Truvada. If lamivudine works against Ebola, then Truvada should work extraordinarily well. But this is exactly what the Corina meeting was designed to put an end to - testing all these currently approved anti-viral drugs that might conflict with the interests of the international pharmaceutical industry that wants to test their own new, hopefully more specific experimental drugs. To paraphrase George Orwell’s Animal Farm, the pharmaceutical corporate paradigm is “Old [cheap] drugs bad. New [expensive] drugs good.”                    

            So why would anyone oppose the use of selenium or lamivudine to treat Ebola, the only two treatments that had shown significant ability to reduce the death toll among those infected? According to the Economist magazine dated 1 November 2014, US and European governments and pharmaceutical companies have spent five hundred million dollars trying to develop drugs to treat Ebola. That was before the 2014 Ebola crisis started. So far they have tested Z-Matt on six patients, three lived, three died. Other anti-Ebola drugs have been rushed forward for trial but we do not know if they will be effective, or if so, how effective. No one knows how safe they are. Do US health agencies and the WHO oppose the use of selenium and NSAIDs to protect that half billion dollar investment? There does not seem to be any solid scientific basis to oppose the use of selenium or lamivudine – and significant scientific rationale to support them. So does the current treatment strategy that ignores the use of selenium actually hurt those infected with Ebola. At the very minimum it lowers the survival rate from a minimum of 68% achieved by administering 1.2 mg selenium daily, down to the basic 45% achieved with supportive care alone. That difference adds up to hundreds of lives lost and families destroyed. Does the current truncated EVD treatment protocol endanger the world by increasing the chance this disease may spread? It might.

            There is a huge conflict of interest here. The health agencies of the US government and the World Health Organization have clearly come down on the side of protecting the commercial interests of the pharmaceutical industry as opposed to saving the lives of people infected with Ebola. People with Ebola will continue to die in unnecessary numbers while the pharmaceutical industry awaits its chance to use them as guinea pigs to test their new drugs. This is a harsh indictment. But when you boil it down to the core residue of the hidden agenda of the protocol review meeting, this seems to be what is left

            Of course we can eventually turn back the tide of this epidemic without ever having to adequately treat the patients who are dying. The same American, European and international organizations I berate here are doing an outstanding job in some places getting a hold on this epidemic. In Liberia they are turning the tide and bringing down the numbers through a combination of education, diligent epidemiological contact tracing, and insuring safe burial practices. But how can we turn our backs on the individuals and families who are suffering most, those who are infected and dying. This is especially true of the local West African doctors and nurses on the front line who have been hit the hardest. The establishment medical superpowers turn their backs on them by ignoring and restricting scientific enquiry and trying to shove quick, simple, cheap clinical trials of existing antiviral drugs into the closet, locking the door and turning off the light. That was the agenda of the Corina Hotel protocol review meeting. That hidden agenda succeeded spectacularly, when from a humanitarian point of view it was a colossal failure.

            The health-interested public deserves an open debate about Ebola research and treatment issues. Those concerns were shoved under the rug in a well-worn, two star hotel in a far off African country with the expectation no one would notice. The editorial in the 18 October Economist magazine cover titled “The War on Ebola” suggested that, “different treatments need to be tested against each other in a systematic way to see which ones work and which will not.” Existing, approved, safe and effective antiviral drugs offer the quickest hope for finding an effective combination therapy to treat Ebola disease. Who will fund this research? It would cost less than one million dollars and take two months to complete testing half a dozen existing, safe antiviral drugs. Who will step up to the plate to do this? Where is a true hero with the financing when the world needs one? A fortune in government money is being thrown at the Ebola epidemic. Some of it, as at the Corina meeting, is used to cover-up and prevent effective therapies from getting to those who need it most. The rational, logical approach to testing potential EVD therapies proposed by the Economist is exactly what the NIH, FDA and the WHO are trying to put a clamp on. Of course testing has to be regulated. But it also needs to be advanced on a logical, scientific basis as fast as humanly possible, and not just as a sop to the pharmaceutical industry. It does not cost much or take long to test drugs against Ebola. Within two to three weeks you know if a medication works or not. It either improves the survival rate or it does not. Nothing else matters to the patient or their family. To shut down testing as the Corina protocol meeting proposed, instead of expediting it, could even be considered criminal. It could contribute to rather than retard the potential spread of Ebola. It also contributes to the death of the doctors, nurses and other healthcare workers who have fought and died bravely battling this epidemic. Holding back research to swiftly find an improved combination of effective therapies contributes to the collapse of the health care systems in the three nations most affected as more and more heath care workers die.

            So the world medical community can follow the liberal, enlightened, nonpartisan advice of the Economist editorial staff. Or it can follow the uber-conservative, corporatist, close-minded, anti-investigative agenda of the US health agencies and the WHO and shut down quick, simple, inexpensive trials. With minimal funding clinical trials could be run by the Ministries of Health of the three affected countries using local doctors - if they were free to do so. It is a clear cut choice. We can save lives and cut this epidemic down to size as rapidly as possible. Or we can continue hoping pharmaceutical companies will come up with something, sooner or later, that might be more or less effective than what is already sitting on the shelf. How long the new drug development process takes to discover drugs more effective than selenium and lamivudine’s much improved successor Truvada, or the combination of the two is anyone’s guess.                       

            The governments of the region need to decide which path to follow – testing as much and as soon as possible or waiting passively for those with superior resources to follow the almost assuredly longer path of new drug research. At an indeterminate future time these companies will present the world with their maybe slightly more superior but much more expensive way to treat Ebola disease. Frankly it would be best to take both the high road and the low road. But do not let anyone blockade the low-tech, quick, simple, easy road just because they prefer the highly technical, lengthy, more difficult high road of experimental investigative new drug development. Given the billions of dollars headed to this poor region that will “sway” the decision, unfortunately hope for a rational humanistic approach to research is fading.          

When accused of being lucky in his discoveries, Louis Pasteur retorted, “Chance favours the prepared mind.” I prepared for this Ebola epidemic through thirty years of experience with and research on HIV disease. Today we need to cut the Gordian knot that Ebola presents. Governments should move rapidly forward to test and discover effective treatments for EVD without delay. They should not place impediments in the way of research other than reasonable regulations designed to expedite rather than shut down the search for a functional cure for this disease. I believe we can turn the untreated survival rate of 10% on its head. Within three months we might achieve a survival rate close to 90% if we add selenium and Truvada to basic supportive care. That will be impossible if West Africa is chained by bureaucratic red tape and led only up the high road of new drug development for the sole purpose of increasing pharmaceutical company profits. That would be neither the medically ethical nor the moral, humanitarian way out of this international health crisis. For even after we put out the fire of the 2014 Ebola epidemic, another Ebola, SARS, MERS or deadly avian influenza epidemic surely awaits around the corner. We should learn the lessons of this epidemic while we can. The 1918 influenza epidemic killed fifty million people worldwide. Next time Ebola, SARS, MERS or influenza could be much worse.

No one should ever again say, “There is no treatment for Ebola.” There is.