(Part 2 of 2)
This is the second part of the summary of testimony heard by Senate Homeland Security and Governmental Affairs Committee on December 8, 2020. It was the second recent hearing on the current progress with early out-patient treatment for COVID-19 and the successes that many front line physicians have had using inexpensive, repurposed drugs.
The previous testimony dealt mostly with the frustrations shared by these doctors trying to fight the war while the “generals,” well-removed from the front lines of the battle field, are making the wrong life-and-death decisions or occasionally the correct ones but at a snail’s pace.
Part one covered most of the opening statements by the six physicians giving testimony. This article deals with the responses the doctors gave to questions from the few committee members in attendance. It appeared only Republican senators Johnson, Paul and Hawley attended leaving senators Portman, Scott, Enzi, Lankford and Romney absent. On the Democrat side, only Senator Peters was initially present but he left immediately after his opening remarks never hearing any of the testimony. Democrat senators absent were Wood Hassen, Carper, Sinema, Harris and Rosen.
The physicians in attendance at the Senate hearing were Drs. Armand Balboni, M.D., Ph.D., CEO of Appili Therapeutics, Jay Bhattacharya, M.D., Ph.D. Professor of Medicine at Stanford University, Pierre Kory, M.D., Pulmonologist and Professor of Medicine at St. Luke’s Aurora Medical Center, Jane Orient, M.D., Executive Director of the Association of American Physicians and Surgeons, Ramin Oskoui, M.D., Cardiologist and CEO of Foxhall Cardiology and Jean-Jacques Rajter, M.D., Pulmonologist at Broward Health Medical Center.
Both Chairman Johnson and Senator Paul asked about how these doctors could tell if the medications they were prescribing, specifically hydroxychloroquine (HCQ) and ivermectin, were the reason for a patient’s rapid recovery or if the patient would have naturally improved on their own.
The question might have been easier to answer last spring when doctors were trying currently approved drugs and therapies on their own without any positive guidance from the NIH or FDA. Now, they say they know what works. They’ve seen it work in their patients and in now numerous observational studies.
Additionally, as some of the physicians noted, the use of a placebo with a COVID patient now becomes a serious ethical question. Can a doctor ignore the solid information provided by his or her own successes and a large observational study and enter into a random clinical trial (RCT) knowing he or she is intentionally denying a patient a likely life-saving drug?
Dr. Pierre Kory touted the benefits of ivermectin. He said the drug, as a prophylaxis, is valuable to more than just the asymptomatic recipient. He gave the example of a COVID positive but asymptomatic 20- or 30-year-old at a family gathering with their at-risk 89-year-old grandma. He said without ivermectin, “we now have a real problem.”
Dr. Kory said, “it literally destroys the virus in most people in 24 hours. so, hence, you take somebody that is asymptomatic, but a carrier with the risk of transmission and you essentially stop that right in their tracks.”
Dr. Armand Balboni responded that though our federal agencies haven’t embraced them, “there are observational studies with thousands of datapoints and hundreds of smaller trials having been run in many countries around the world” [regarding ivermectin].
Bureaucratic organizations like the NIH and FDA need to develop “hybrid trial methodologies to combine all of these traditional RCTs and observational study designs to gather real world evidence” to just satisfy themselves.
Dr. Balboni said, “As a physician, I’m trying to do the right thing for patients [but] we need assistance.” He again urged these agencies to participate in a “true public/private partnership.” The NIH must shed its typical bureaucratic way of doing things given we are in the viral equivalent of a major war.
Dr. Jane Orient gave one of the most important responses in the entire hearing. Now that we are in the middle of a major pandemic, she asked, aren’t “there are the ethical questions (to consider with a double blind study)? If you have something that’s going to protect your grandma if it works and doing nothing is going to put your grandma at risk, then are you engaging some kind of human sacrifice to use a placebo?”
“If you have something that’s going to protect your grandma if it works and doing nothing is going to put your grandma at risk, then are you engaging some kind of human sacrifice to use a placebo?”
Her point was powerful. For example, if you have substantial observational studies that clearly show that HCQ or ivermectin either mitigate or eliminate symptoms, how can you ethically give someone a placebo?
Dr. Orient added, “Some people have even suggested that maybe the RCT is outdated and we should be looking at other statistical approaches
Dr. Jay Bhattacharya actually prefers observational studies to RCTs under these circumstances. He said statistical methods can correct for “selection bias and treatment [and] you actually can get very large (accurate) samples relatively inexpensively.”
Chairman Johnson presented two questions to the assembled physicians: “One, can you describe why government doesn’t have the incentive to run these trials? We know the private sector doesn’t. They cost millions and millions of dollars, and if it’s a generic drug, there is no incentive other than in government. And it should be the NIH or the CDC or the FDA that voluntary advocates for all citizens in prescribing drugs? Can you tell us why that didn’t occur?
Dr. Jean-Jacques Rajter responded first. He said though his organization is “having fruitful discussions” with the FDA, it is “not moving quickly.”
He candidly added that there just doesn’t seem to be any urgency. They are “treating many of these products as if they were for chronic diseases. That’s the structure of these organizations, is to review thoughtfully and take the time to look at all the data.”
Dr. Rajter hoped his appearance in this hearing would help force change in this bureaucratic agencies. They are clearly under stress but that stress isn’t making them move any faster, it actually appears to be slowing them down as they cling to their old, comfortable methods. “I think they fall back on what they know, which is reviewing and approving drugs like cardiovascular drugs, which they can take more time with.”
“We have to move them (NIH, FDA and CDC) out of their comfort zone, work with them on new policies, and I hope you … can enforce those policies and get them to think more creatively during a pandemic.”
“I think there needs to be both a forcing function for supporting their efforts to move outside of what is tried and true in their review process,” Dr. Rajter asserted.
He added, “We have to move them out of their comfort zone, work with them on new policies, and I hope your colleagues, with your hands on those levers, can enforce those policies and get them to think more creatively during a pandemic.”
In responding to a question about the safety risks of the ivermectin and HCQ, Dr. Kory asserted, “As a physician, every decision I make therapeutically, involves exactly that question which is a risk-benefit analysis.”
Dr. Kory said that the very first consideration for prescribing any medication is its safety. He said these drugs (HCQ and ivermectin) are extremely safe. “So if the therapy I have is either low-cost, low-resource or extremely safe, and its potential for benefit is high, that would win the risk benefit analysis and you should be giving it.”
Without guidance from the federal agencies — that truly exist for a major disease breakout like this— physicians early in the pandemic were faced with trying to find creative solutions on their own to literally save the lives of their patients. “When you look at the mortality and morbidity of this disease which is unparalleled, we’re seeing countless deaths, and it’s horrific the way they’re dying, and you look at these safe and low-cost agents, it seems like a no-brainer that you should try it,” Dr. Kory stressed.
“(Regarding the safety of ivermectin). 3.7 billion doses have been administered since it was discovered in 1997. It has an unparalleled safety profile with almost no side effects,” Dr. Kory assured the committee.
Responding to a question from Chairman Johnson about the safety, specifically of HCQ, Dr. Orient said other countries have done much of the trial work that we (our federal agencies) should look at.
She said in Brazil, for example, one part of the country embraces the drug while another part forbids its use. There is a big difference in the mortality rates between the two with the part using HCQ being considerably lower.
Dr. Orient said, “In Switzerland, the mortality rate went up when they stopped using it because of the terror provoked by that “Lancet” study, and it came down again when the Swiss went back to using it.”
She said that the two drugs that frontline physicians have had the best successes with (ivermectin and HCQ) “both have a lot of potential, and sometimes patients respond better to one than to the other.”
Dr. Orient also brought up reports that the CDC was getting calls about poisonings due to HCQ. She said these calls purportedly “doubled, went up to 35. If you look at hand sanitizer, there were 33,000 hand sanitizer reports to the poison control center which was an increase of 73%, and for acetaminophen, which everybody recommends that you take instead of some of the drugs that might help you, there were 50,000 cases of just exposure to that alone and another 23,000 in combination and 65 and 42 deaths respectively.”
Dr. Kory again pressed the point that the federal agencies have (1) not stepped up the urgency in dealing with this deadly pandemic and (2) are putting all their efforts into vaccines and hospitalized inpatient treatments. These are some of the reasons why many state governors are shutting down businesses but failing keep people out of hospitals. The efforts and policies exhibited thus far by the federal bureaucracies appear to want more COVID patients in hospitals.
Specifically regarding Dr. Fauci and the NIH, Dr. Kory stated, “I don’t want to attack the NIH for getting it wrong. They didn’t necessarily get it wrong, they’re just not keeping up with the data.”
He concluded his remarks with a strong recommendation, “Ivermectin has shown itself to be a highly elective treatment and it needs to be adopted globally, period.”
“Ivermectin has shown itself to be a highly elective treatment and it needs to be adopted globally, period.”
Dr. Rajter closed his remarks by expressing his frustration with Washington’s roadblocks and apparent indifference with early treatments. “As a front line provider, I’ve been treating COVID pretty much every single day since the onset. I’ve only had pretty much seven days off since December 31st. Every other day has been taking care of COVID patients in the hospital.”
“Ivermectin is effective. it’s effective in early disease. It’s effective in late disease. It’s effective as a prophylaxis. It’s an oral medication, you do not need to monitor on anything. There’s hardly a reaction. you can administer this medication in any condition. It’s safe, inexpensive and widely available,” Dr. Rajter affirmed.
“Ivermectin is effective. it’s effective in early disease. It’s effective in late disease. It’s effective as a prophylaxis. It’s an oral medication, you do not need to monitor on anything. There’s hardly a reaction. you can administer this medication in any condition. It’s safe, inexpensive and widely available.”
Dr. Rajter pleaded, “We need to get people at the regulatory agencies to review the current data to see how effective this (ivermectin) is… I implore you, senators, to really help us front line providers… We have the answers, but (need) to make other regulatory agencies come on board. Do not chastise physicians who have been thinking outside of the box, because honestly the box has failed us.”
“I implore you, senators, to really help us front line providers… We have the answers, but (need) to make other regulatory agencies come on board. Do not chastise physicians who have been thinking outside of the box, because honestly the box has failed us.”
His final statement included a warning. “We really need to attack this together, and we need to try to save as many people as we can, because I cannot continue to stand by and see hundreds upon hundreds of people die in hospitals, thousands of people, hundreds of thousands of people dying across the country.”
But it seems like the FDA and Dr. Fauci’s NIH have not put much effort into examining the most up-to-date information and studies on inexpensive, repurposed medications. In fact, it ostensibly has done everything to stop their use in the face of considerable evidence and now expert testimony from front line doctors who shout the success of these medications.
These physicians, and particularly Dr. Rajter, seemed to convey that it is likely there is big money working against the use of these cheap and effective drugs. Behind the scenes lobbying and arm twisting cannot be ruled out in Washington when big pharma would like to see more expensive drugs (e.g., remdesivir) widely prescribed and hospitals are still receiving premium payments for COVID patients.)
The key question though might be: In the face of over 300,000 dead Americans will the NIH, FDA and CDC take a more urgent approach to early treatment — or will they reflect the priorities of 11 of the 14 senators on this committee who didn’t even bother to show up to hear this life-and-death testimony?