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FTR #1166 This program was recorded in one, 60-minute segment [5].
Introduction: Supplementing FTR #1138 [6], this program continues discussion about drug treatments for, and vaccines to prevent, Covid-19.
In previous posts and programs, we have noted [7] that Moderna’s vaccine work has been financed by DARPA. We have also noted that the overall head of Operation Warp Speed is Moncef Slaoui [8], formerly in charge of product development for Moderna!
Of great significance is the central role of the military in the development of treatment for Covid-19:
- The program notes that [9]: ” . . . . Remdesivir predates this pandemic. It was first considered as a potential treatment for Ebola [10], and was developed through a longstanding partnership between the U.S. Army and the Centers for Disease Control and Prevention. . . .”
- Jonathan King, who has chaired the microbial physiology study section for the NIH has sounded the alarm about “vaccine research” masking offensive biological warfare research: “. . . . King, who has chaired the microbial physiology study section for the NIH, believes that without intensive independent scrutiny, the Pentagon is free to obscure its true goals. ‘The Defense Department appears to be pursuing many narrow, applied goals that are by nature offensive, such as the genetic ‘improvement’ of BW agents,’ King says. ‘But to achieve political acceptability, they mask these intentions under forms of research, such as vaccine development, which sound defensive. . . .”
- Moderna’s vaccine development was overseen [11] by an unnamed Pentagon official: ” . . . . Moderna’s team was headed by a Defense Department official whom company executives described only as ‘the major,’ saying they don’t know if his name is supposed to be a secret. . . . .”
- The pervasive role [11] of the military in Operation Warp Speed (the Trump administration’s vaccine development program) has generated alarm in civilian participants:”. . . . Scores of Defense Department employees are laced through the government offices involved in the effort, making up a large portion of the federal personnel devoted to the effort. Those numbers have led some current and former officials at the Centers for Disease Control and Prevention to privately grumble that the military’s role in Operation Warp Speed was too large for a task that is, at its core, a public health campaign. . . .”
- General Gustave Perna–one of the principals in Operation Warp Speed–has chosen [11] a retired Lieutenant General to oversee much of the program: ” . . . . ‘Frankly, it has been breathtaking to watch,’ said Paul Ostrowski, the director of supply, production and distribution for Operation Warp Speed. He is a retired Army lieutenant general who was selected to manage logistics for the program by Gen. Gustave F. Perna [12], the chief operating officer for Operation Warp Speed. . . .”
- The military will be able to trace [11] the destination and administration of each dose: ” . . . . Military officials also came up with the clever idea — if it works — to coordinate the delivery of vaccines to drugstores, medical centers and other immunization sites by sending kits full of needles, syringes and alcohol wipes. Vaccine makers will be alerted when the kits arrive at an immunization site so they know to ship doses. Once the first dose is given, the manufacturer will be notified so it can send the second dose with a patient’s name attached several weeks later. The military will also monitor vaccine distribution through an operations center. ‘They will know where every vaccine dose is,’ Mr. [Paul] Mango said on a call with reporters. . . .”
This program begins with information about the ongoing professional massaging of Gilead Sciences’ anti-viral remdesivir.
The most positive studies have proved remdesivir/Veklury only modestly successful against SARS Cov‑2 (the virus that causes Covid-19). Remdesivir (now marketed under the brand name Veklury) has been propelled to the forefront of treatment regimens for the pandemic, a development [9] which appears to diminish the chances for a competing, more effective drug to gain professional approval for treating Covid-19.
” . . . . Other studies have shown no benefit, including the World Health Organization’s Solidarity trial, released as a preprint [13] on Oct. 15. Based on these results, the European Society of Intensive Care Medicine is now recommending that the drug not be routinely used in hospitalized Covid-19 patients [14]. Infectious disease experts [15] have stated that after examining all available evidence, we can reasonably conclude only that remdesivir may work. . . .”
Deeply disturbing, as well, is the news that the “positive news” about vaccine success and development has been generated by press releases [16] from the companies that manufacture them: ” . . . . But the companies announced the findings in news releases, not in peer-reviewed scientific journals, and did not disclose the detailed data that would allow outside experts to evaluate their claims. Therefore, the results cannot be considered conclusive. The figures on effectiveness may change as the studies continue. . . .”
Program Highlights Include: The rapid spread of the disease is benefitting the speed-up of vaccine research; how regulatory procedures for Big Pharma products were already being attenuated before the Covid-19 “op;” review of the attenuated, manipulated NIAID study on remdesivir that generated positive news, a run-up in the stock price of Gilead Sciences and a boost for the market as a whole; review of the role of “Scientists to Stop Covid-19” in massaging the vetting process for remdesivir; review of the CDC’s closing of the USAMRIID in August of 2019 and the testing of remdeisivir at that facility in March of 2019; review of the insidious, incestuous relationship between the authorities “regulating” treatment of Lyme Disease and those who benefit from the administration of that treatment; review of Lyme Disease as a biological warfare weapon.
1. Expanding our coverage of Gilead Sciences’ anti-viral remdesivir, the program notes that: ” . . . . Remdesivir predates this pandemic. It was first considered as a potential treatment for Ebola [10], and was developed through a longstanding partnership between the U.S. Army and the Centers for Disease Control and Prevention. . . .”
“Does Remdesivir Work?” by Ravi Gupta and Reshma Ramachandran; The New York Times; 11/18/2020. [9]
When the Food and Drug Administration approves a new treatment or vaccine, as doctors we are assured that rigorous studies have proven it to be safe and effective. But the F.D.A.’s haphazard issuance of emergency use authorizations for Covid-19 treatments like hydroxychloroquine [17] and convalescent plasma [18], whose potential benefits have not yet been backed up by data, has undermined this trust.
Early in the pandemic, the agency awarded an emergency use authorization for the antiviral drug remdesivir, based on evidence suggesting that it [19]may [19] be effective [19]. Then last month, despite conflicting evidence [20], the F.D.A. prematurely granted its first full approval for Covid-19 treatment to remdesivir [21], now marketed as Veklury.
In early October, The New England Journal of Medicine published a report [22] on the results of a trial funded by the National Institutes of Health that found that remdesivir decreased recovery time in Covid-19 patients who were hospitalized with less severe illness, but did not curb mortality. Other studies have shown no benefit, including the World Health Organization’s Solidarity trial, released as a preprint [13] on Oct. 15.
Based on these results, the European Society of Intensive Care Medicine is now recommending that the drug not be routinely used in hospitalized Covid-19 patients [14]. Infectious disease experts [15] have stated that after examining all available evidence, we can reasonably conclude only that remdesivir may work.
Some have argued that the approval of Veklury is justified even if it is only mildly effective because there are no other proven therapies for Covid-19. This fails to acknowledge, however, the proven effectiveness of drugs like dexamethasone [23], a cheap and widely used steroid.
It also ignores years of assault on F.D.A. evidentiary standards, accelerated by the passage in 2016 of the 21st-Century Cures Act [24]. This legislation, which sped up the F.D.A.’s approval process, was based on unfounded claims that the agency was too slow and hindered patients’ access to lifesaving drugs.
The F.D.A. is now increasingly approving new drugs based on weaker evidence [25], relying on “surrogate [26]measures” like changes in tumor size [27] in lieu of more meaningful clinical outcomes such as reduced mortality or hospitalizations. Recent cancer drugs, for example, have been approved without evidence of improving overall survival [28]. Weaker standards are a boon to pharmaceutical companies, but they can also depress the development of truly innovative and effective treatments.
The F.D.A. has tried to offset its accelerated approval of Veklury by asking its maker, Gilead, to complete 29 post-market studies to further examine the drug’s effectiveness and safety. This is more than three [29] to four [30] times the number typically requested. It’s unclear, however, if these studies will ever be done. One report found that, five to six years following approval, only half of post-market studies [31] had been completed and one-fifth hadn’t even been started.
Veklury’s approval could also have a chilling effect on the F.D.A.’s ability to issue emergency use authorizations for other potentially effective Covid-19 treatments, as the agency’s guidance requires [32] there be “no adequate, approved and available alternative” for the disease. Just last week, the F.D.A. granted an authorization to an antibody treatment called bamlanivimab [33], for use in non-hospitalized patients with Covid-19 who are at the highest risk of developing severe disease. This may have been possible only because Veklury was approved specifically for hospitalized patients.
Veklury’s questionable effectiveness is even more problematic given the drug’s price. A course costs $3,120 — a huge price tag, and one that ignores the substantial public investment in the drug’s development.
Remdesivir predates this pandemic. It was first considered as a potential treatment for Ebola [10], and was developed through a longstanding partnership between the U.S. Army and the Centers for Disease Control and Prevention. It was repurposed for Covid-19 after multimillion-dollar trials sponsored by the N.I.H [34]. suggested it could work against coronaviruses.
Despite Veklury’s questionable effectiveness, the F.D.A. has also awarded Gilead a “priority review voucher” worth $75 to $100 million. This voucher can be used by Gilead or sold to a different manufacturer to hasten review [35] of another drug application. This would perpetuate the entry of other treatments that are hurriedly reviewed and, like remdesivir, may be of uncertain benefit.
The dangers posed by the F.D.A.’s rush in approving Veklury are compounded by the chaos of presumed political interference by the Trump administration. But the weakening of F.D.A. standards will most likely continue under the Biden administration. When he was vice president, Joe Biden strongly endorsed [36] the 21st-Century Cures Act, and some in Congress are already pushing for its next iteration, Cures 2.0.
If passed, it would further erode [37] the F.D.A.’s evidentiary standards. Among Cures 2.0 proposals is moving the basis for approval away from randomized, controlled trials, long considered the gold standard of evidence, and instead relying more on observational evidence and surrogate measures.
It is hard to ask people to wait for the evidence when there’s a treatment that could hold some promise, especially during a devastating pandemic. But the hasty approval of expensive new treatments like remdesivir isn’t the solution. Doctors like us must feel confident that the drugs approved by the F.D.A. are worth prescribing to our patients.
Ravi Gupta (@rgupta729 [38]) is an internal medicine physician and a fellow at the National Clinician Scholars Program at the University of Pennsylvania. Reshma Ramachandran (@reshmagar [39]) is a family medicine physician and a fellow at the National Clinician Scholars Program at Yale University. They are both members of the Doctors for America Drug Affordability Action Team.
2a. Pivoting to discussion and review of the political, financial and corporate connections to the development of medicinal treatments for, and vaccines to prevent, Covid-19, we recap details relevant to the extraordinary timing of a 4/29 announcement of favorable results for a trial of remdesivir. That announcement drove equities markets higher and was beneficial to the stock of Gilead Sciences.
We present a Stat News [40] article on the internal deliberations behind the decisions to modify the NIAID study. Of particular significance is the DSMB deliberation. Note the timeline of the DSMB deliberation, combined with the announcement on 4/29 that drove the markets higher.
- The decision was made to cut it short before the question of remdesivir’s impact on mortality could be answered: ” . . . .The National Institute of Allergy and Infectious Diseases has described to STAT in new detail how it made its fateful decision: to start giving remdesivir to patients who had been assigned to receive a placebo in the study, essentially limiting researchers’ ability to collect more data about whether the drug saves lives — something the study, called ACTT‑1, suggests but does not prove. In the trial, 8% of the participants given remdesivir died, compared with 11.6% of the placebo group, a difference that was not statistically significant. A top NIAID official said he had no regrets about the decision. ‘There certainly was unanimity within the institute that this was the right thing to do,’ said H. Clifford Lane, NIAID’s clinical director. . . .”
- In addition, patients scheduled to receive placebo received remdesivir, instead. ” . . . . Steven Nissen, a veteran trialist and cardiologist at the Cleveland Clinic, disagreed that giving placebo patients remdesivir was the right call. ‘I believe it is in society’s best interest to determine whether remdesivir can reduce mortality, and with the release of this information doing a placebo-controlled trial to determine if there is a mortality benefit will be very difficult,’ he said. ‘The question is: Was there a route, or is there a route, to determine if the drug can prevent death?’ The decision is ‘a lost opportunity,’ he said. . . .”
- Steven Nissen was not alone in his criticism of the NIAID’s decision. ” . . . .Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, agreed with Nissen. ‘The core understanding of clinical research participation and clinical research conduct is we run the trial rigorously to provide the most accurate information about the right treatment,’ he said. And that answer, he argued, should ideally have determined whether remdesivir saves lives. The reason we have shut our whole society down, Bach said, is not to prevent Covid-19 patients from spending a few more days in the hospital. It is to prevent patients from dying. ‘Mortality is the right endpoint,’ he said. . . .”
- Not only was the administration of remdesivir instead of placebo prioritized, but the NIAID study itself was attenuated! ” . . . . But the change in the study’s main goal also changed the way the study would be analyzed. Now, the NIAID decided, the analysis would be calculated when 400 patients out of the 1,063 patients the study enrolled had recovered. If remdesivir turned out to be much more effective than expected, ‘interim’ analyses would be conducted at a third and two-thirds that number.The job of reviewing these analyses would fall to a committee of outside experts on what is known as an independent data and safety monitoring board, or DSMB. . . .”
- The performance of the DSMB for the remdesivir study is noteworthy: ” . . . . But the DSMB for the remdesivir study did not ever meet for an interim efficacy analysis, Lane said. All patients had been enrolled by April 20. The data for a DSMB meeting was cut off on April 22. The DSMB met and, on April 27, it made a recommendation to the NIAID. . . .”
- The DSMB meeting on 4/27 determined the switch from placebo to remdesivir. Of paramount importance is the fact that this was JUST BEFORE the 4/29 announcement that drove the markets higher and the same day on which key Trump aide–and former Gilead Sciences lobbyist Joe Grogan resigned! ” . . . . . That decision, Lane said, led the NIAID to conclude that patients who had been given placebo should be offered remdesivir, something that started happening after April 28. . . .”
- Dr. Ethan Weiss gave an accurate evaluation of the NIAID study: ” . . . . ‘We’ve squandered an incredible opportunity to do good science,’ [Dr. Ethan] Weiss said. ‘If we could ever go back and do something all over, it would be the infrastructure to actually learn something. Because we’re not learning enough.’ . . . .”
The remarkable handling of the NIAID study, the timing of the announcement of the altogether limited success of the attenuated trial and the rise in equities as a result of the announcement may be best understood in the context of the role played [41] in Trump pandemic decision-making by an elite group of billionaires and scientists–including convicted felon Michael Milken (the “junk bond king”).
- ” . . . . Calling themselves ‘Scientists to Stop COVID-19,’ the collection of top researchers, billionaires and industry captains will act as an ‘ad hoc review board’ for the torrent of coronavirus research, ‘weeding out’ flawed data before it reaches policymakers, the Wall Street Journal [42] reported on Monday. They are also acting as a go-between for pharmaceutical companies seeking to build a communication channel with Trump administration officials. The group . . . . has advised Nick Ayers, an aide to Vice President Mike Pence [43], as well as other agency heads, in the past month. Pence is heading up the White House coronavirus task force. . . .”
- ” . . . The brainy bunch is led by Thomas Cahill, a 33-year-old doctor who became a venture capitalist . . . . Cahill’s clout comes from building connections through his investment firm, Newpath Partners, with Silicon Valley’s Peter Thiel, the founder of PayPal, and billionaire businessmen Jim Palotta and Michael Milken. . . .”
Note that Peter Thiel played a dominant role in bankrolling Newpath Partners, and the other financial angel who elevated Cahill–Brian Sheth–introduced him to Tommy Hicks, Jr., [44]the co-chairman of the RNC. In FTR #‘s 1111 [45] and 1112 [45], we looked at Hicks’ networking with Steve Bannon associate J. Kyle Bass, as well as his role in the inter-agency networks driving the anti-China effort.
” . . . . At the helm of the effort: The 33-year-old and very-much-under-the-radar venture capitalist Tom Cahill, who leads life sciences-focused Newpath Partners. Cahill completed his M.D. and PhD at Duke University a mere two years ago before landing at blue-chip investment firm Raptor Group through a friend. He went on to found Newpath with some $125 million after impressing well-connected names like venture capitalist Peter Thiel and Vista Equity Partners co-founder Brian Sheth. . . . It was through Sheth, for example, that Scientists to Stop Covid-19 connected with the co-chairman of the Republican National Committee, Thomas Hicks Jr. . . .”
The federal government’s extreme focus on remdesivir has been shaped, in large measure [46], by the influence of “Scientists to Stop COVID-19”:
- “Scientists to Stop Covid-19” is shepherding remdesivir: ” . . . . Scientists to Stop COVID-19 recommends that in this phase, the U.S. Food and Drug Administration (FDA) should work to coordinate with Gilead pharmaceuticals to focus on expediting the results of clinical trials of remdesivir, a drug identified as a potential treatment for COVID-19. The group also recommends administering doses of the drug to patients in an early stage of infection, and notes remdesivir will essentially be a placeholder until a more effective treatment is produced.
- The group is doing so by attenuating the regulatory process for coronavirus drugs: “Government entities and agencies appear to adhere to the recommendations outlined by the group, with the Journal reporting that the FDA and the Department of Veterans Affairs (VA) have implemented some of the suggestions, namely relaxing drug manufacturer regulations and requirements for potential coronavirus treatment drugs. . . .”
We conclude discussion of the remdesivir machinations with a piece about the timing [47] of the announcement of Grogan’s departure.
” . . . . Grogan has served as the director of the White House Domestic Policy Council since February 2019, overseeing a broad array of policy issues including health care and regulation. . . . Grogan was one of the original members of the White House coronavirus task force launched in late January. . . . Grogan worked as a lobbyist for drug company Gilead Sciences before joining the Trump administration. . . .”
The departure was announced in the Wall Street Journal on the morning of Wednesday, April 29, the same day we got our first public reports of the NIAID clinical trial of remdesivir that was positive enough to show it shortened the time to recovery and the same day the FDA granted remdesivir emergency use status.
Note, again, the timing of the DSMB’s actions, as well as the influence of “Scientists to Stop Covid-19.”
2b. Of particular interest in the context of the professional massaging of remdesivir are the circumstances surrounding the CDC’s closure of the U.S. Army Medical Research Institute of Infectious Diseases. The USAMRIID–located at Ft. Detrick–had hosted Gilead Sciences’ animal trials of remdesivir. Remdesivir was developed to combat Ebola, and was a failure in its initial professional iteration.
In March of 2019, rhesus macaques were infected with Ebola [48] at the USAMRIID as part of a project to allow remdesivir to be marketed as an Ebola treatment without meeting the professional standards of human testing. ” . . . This agreement was made possible through a 2018 Natural History Study (NHS) of Ebola virus conducted by USAMRIID in close collaboration with Gilead Sciences, Inc., the sponsor of remdesivir development . . .”
Many of the safety violations [49] cited by the CDC in its critique of USAMRIID safety and security procedures concerned “non-human primates” infected with one or more “select agents” that were not named. The term “select agent” refers to a pathogen being used in laboratory procedures. Whether the “select agent” was Ebola, and whether the safety lapses were in connection with the remdesivir/rhesus monkey trials was not disclosed.
” . . . . Several of the laboratory violations the CDC noted in 2019 concerned ‘non-human primates’ infected with a ‘select agent’, the identity of which is unknown — it was redacted in all received documents, because disclosing the identity and location of the agent would endanger public health or safety, the agency says. In addition to Ebola, the lab works with other deadly agents like anthrax and smallpox. . . ..”
If, for the sake of argument, SARS-CoV‑2 research was indeed taking placing there was a very real risk of it escaping.
3a. Jonathan King, who has chaired the microbial physiology study section for the NIH has sounded the alarm about “vaccine research” masking offensive biological warfare research:
. . . . King, who has chaired the microbial physiology study section for the NIH, believes that without intensive independent scrutiny, the Pentagon is free to obscure its true goals.
“The Defense Department appears to be pursuing many narrow, applied goals that are by nature offensive, such as the genetic ‘improvement’ of BW agents,” King says. “But to achieve political acceptability, they mask these intentions under forms of research, such as vaccine development, which sound defensive. . . .
3b. Deeply disturbing, as well, is the news that the “positive news” about vaccine success and development has been generated by press releases [16] from the companies that manufacture them:
“Another Vaccine Appears to Work Against the Virus” by Denise Grady; The New York Times [16]; 11/17/2020. [16]
. . . . But the companies announced the findings in news releases, not in peer-reviewed scientific journals, and did not disclose the detailed data that would allow outside experts to evaluate their claims. Therefore, the results cannot be considered conclusive. The figures on effectiveness may change as the studies continue. . . .
4a. Moderna’s vaccine development was overseen [11] by an unnamed Pentagon official:
. . . . Moderna’s team was headed by a Defense Department official whom company executives described only as “the major,” saying they don’t know if his name is supposed to be a secret. . . . .
4b. The rapid spread of the disease is benefitting the speed-up of vaccine research.
The coronavirus is spreading out of control in the United States, overwhelming health systems and killing more than 1,100 Americans a day. But there is a slender silver lining: It is hastening the testing of vaccines that could eventually end the pandemic.
The surging virus has already allowed Pfizer and Moderna to accelerate the testing of their vaccines, which appear to be very effective at preventing Covid-19.
And if, as seems inevitable, the virus continues to proliferate — it is spreading faster than ever in the United States and some other countries — it is likely to speed the evaluations of promising vaccine candidates from other pharmaceutical companies. . . .
5. Of great significance is the central role of the military in the development of treatment for Covid-19:
When President Trump [53] talks about efforts to deliver the coronavirus vaccine to millions of Americans eager to return to their normal lives, he often says he is “counting on the military” to get it done. . . .
. . . . In reality, the role of the military has been less public and more pervasive than this characterization suggests. . . .
. . . . Scores of Defense Department employees are laced through the government offices involved in the effort, making up a large portion of the federal personnel devoted to the effort. Those numbers have led some current and former officials at the Centers for Disease Control and Prevention to privately grumble that the military’s role in Operation Warp Speed was too large for a task that is, at its core, a public health campaign.
“Frankly, it has been breathtaking to watch,” said Paul Ostrowski, the director of supply, production and distribution for Operation Warp Speed. He is a retired Army lieutenant general who was selected to manage logistics for the program by Gen. Gustave F. Perna [12], the chief operating officer for Operation Warp Speed.
Wrangling volunteers for four expedited vaccine trials — a chore in any circumstance — became even more challenging during a pandemic, when asking hundreds of thousands of subjects to sit in hospital waiting rooms and other health care centers was often not feasible. The Pentagon has helped three companies — AstraZeneca, Moderna and Janssen — set up pop-up sites to conduct trials at 63 locations nationwide. . . .
. . . . These are the types of things that the military can quickly obtain through its contracting system, as well as any permits needed to set it all up. “We have the ability to set up large-scale housing capabilities throughout the entire world at a moment’s notice,” General Ostrowski said. . . .
. . . . Military officials also came up with the clever idea — if it works — to coordinate the delivery of vaccines to drugstores, medical centers and other immunization sites by sending kits full of needles, syringes and alcohol wipes. Vaccine makers will be alerted when the kits arrive at an immunization site so they know to ship doses. Once the first dose is given, the manufacturer will be notified so it can send the second dose with a patient’s name attached several weeks later. . . .
. . . . The military will also monitor vaccine distribution through an operations center. “They will know where every vaccine dose is,” Mr. [Paul] Mango said on a call with reporters. [Mango is the deputy chief of staff for policy at the Department of Health and Human Services and the main spokesman for Operation Warp Speed.–D.E.] “If a vaccine dose is at risk of expiring, they will gide the movement of that to someplace else.” . . . .
6. Pivoting to discussion of the politics of Lyme Disease treatment, we note that legal and regulatory rulings have enabled the patenting of living organisms and that has exacerbated the monetizing of Lyme Disease treatment. That monetization, in turn, has adversely affected the quality of care for afflicted patients. ” . . . . All of a sudden, the institutions that were supposed to be protectors of public health became business partners with Big Pharma. The university researchers who had previously shared information on dangerous emerging diseases were now delaying publishing their findings so they could become entrepreneurs and profit from patents through their university technology transfer groups. We essentially lost our system of scientific checks and balances. And this, in turn, has undermined patient trust in the institutions that are supposed to ‘do no harm.’ . . .”
. . . . Thinking back on my research for the Lyme documentary Under Our Skin, I concluded that there was much more money at stake with Lyme Disease. It was the first major new disease discovered after the Bayh-Dole Act and the Diamond v. Chakrabarty Supreme Court decision made it possible for the NIH, the CDC, and universities to patent and profit from “ownership” of live organisms. When the causative organism behind Lyme disease was announced, something akin to the Oklahoma Land Rush of 1889 began, as scientists within these institutions began furiously filing patents on the surface proteins and DNA of the Lyme spirochete, hoping to profit from future vaccines and diagnostic tests that used these markers–for example, an NIH employee who patents a bacterial surface protein used in a commercial test kit or a vaccine could receive up to $150,000 in royalty payments a year, an amount that might double his or her annual salary. All of a sudden, the institutions that were supposed to be protectors of public health became business partners with Big Pharma. The university researchers who had previously shared information on dangerous emerging diseases were now delaying publishing their findings so they could become entrepreneurs and profit from patents through their university technology transfer groups. We essentially lost our system of scientific checks and balances. And this, in turn, has undermined patient trust in the institutions that are supposed to “do no harm.”
With Lyme disease, there’s no profit incentive for proactively treating someone with a few weeks of inexpensive, off-patent antibiotics. It’s the patentable vaccines and mandatory tests-before-treatment that bring in the steady revenues year after year. . . .
7. Bitten author Kris Newby went up against the “Lyme Disease establishment” in an attempt to find out why the disease was being mis-diagnosed and ineffectively treated. Strikingly, a FOIA suit she filed was stonewalled, before finally yielding the documents she had so long sought.
The “experts” and their agenda was neatly, and alarmingly, summed up by Ms. Newby:
” . . . . The emails revealed a disturbing picture of a nonofficial group of government employees and guidelines authors that had been setting the national Lyme disease research agenda without public oversight or transparency. . . . Bottom line, the guidelines authors regularly convened in government-funded, closed-door meetings with hidden agendas that lined the pockets of academic researchers with significant commercial interests in Lyme disease tests and vaccines. A large percentage of government grants were awarded to the guideline authors and/or researchers in their labs. Part of the group’s stated mission, culled from these FOIA emails, was to run a covert ‘disinformation war’ and a ‘sociopolitical offensive’ to discredit Lyme patients, physicians, and journalists who questioned the group’s research and motives. In the FOIA-obtained emails, Lyme patients and their treating physicians were called ‘loonies’ and ‘quacks’ by Lyme guidelines authors and NIH employees. . . .”
. . . . In the IDSA [Infectious Diseases Society of America] guidelines, chronic Lyme isn’t classified as an ongoing, persistent infection; it’s considered either an autoimmune syndrome (in which a body’s immune system attacks itself) or a psychological condition caused by “the aches and pains of daily living” or “prior traumatic psychological events.” These guidelines were often used by medical insurers to deny treatment, and many of its authors are paid consulting fees to testify as expert witnesses in these insurance cases. In some states, the guideline recommendations take on the force of law, so that Lyme physicians who practice outside them are at risk of losing their medical licenses.
The protestors were angry because, as part of a 2008 antitrust settlement brought by Connecticut attorney general Richard Blumenthal (now a senator), the IDSA guidelines were supposed to appoint an expert panel without biases or conflicts to do a re-review of the guidelines. In the settlement press release, Blumenthal had written, “My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA’s guideline panel improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.”
In response, the IDSA leadership selected a review panel of doctors and scientists, and they determined that “No changes or revisions to the 2006 Lyme guidelines are necessary at this time.”
Lorraine Johnson, JD, MBA, the chief executive officer of LymeDisease.org, and a champion of the IDSA antitrust suit, maintains that the review panel was stacked with like-minded cronies of the original guidelines’ authors and was therefore biased. She cites the recent article by research quality expert and Stanford professor John Ioannidis, MD, DSc, who recommends that “Professional societies should consider disentangling their specialists from guidelines and disease definitions and listen to what more impartial stakeholders think about their practices.”
Today, in 2019, these controversial guidelines and disputed tests are still influencing Lyme patient care.
People often ask me why the IDSA and CDC would support the problematic two-tier Lyme test. During my documentary research, I tried to get an answer to this question with a Freedom of Information Act (FOIA) request that solicited emails between three CDC employees and the IDSA guidelines authors. For five years the CDC strung me along with frivolous denials, unexplained delays, and false promises. In essence, the delays became an illegal, off-the-books FOIA denial. Some delays were attributed to understaffing, year-end deadlines, and CDC personnel out for vacation. At one point, my unanswered calls were blamed on a phone “dead zone” in the CDC’s new FOIA office. After the Lyme documentary Under Our Skin was released, I decided to double-down on my efforts to dislodge the FOIA request. My congressperson sent several letters to the CDC. The director of the documentary wrote a letter to President Obama. The FOIA ombudsman in the Office of Government Information Services repeatedly pressured the CDC to fulfill my request. I published blog posts about my plight and enlisted the support of a number of organizations dedicated to ensuring government transparency. Finally, the CDC sent three-thousand-plus FOIA pages, and I then understood its motivation for having delayed their release.
The emails revealed a disturbing picture of a nonofficial group of government employees and guidelines authors that had been setting the national Lyme disease research agenda without public oversight or transparency. Investigative journalist Mary Beth Pfeiffer of the Poughkeepsie Journal was given access to these emails, and on May 20, 2013. She published an expose on this group’s abuse of power.
Bottom line, the guidelines authors regularly convened in government-funded, closed-door meetings with hidden agendas that lined the pockets of academic researchers with significant commercial interests in Lyme disease tests and vaccines. A large percentage of government grants were awarded to the guideline authors and/or researchers in their labs.
Part of the group’s stated mission, culled from these FOIA emails, was to run a covert “disinformation war” and a “sociopolitical offensive” to discredit Lyme patients, physicians, and journalists who questioned the group’s research and motives. In the FOIA-obtained emails, Lyme patients and their treating physicians were called “loonies” and “quacks’ by Lyme guidelines authors and NIH employees.
Because my FOIA request ended up taking five years to process, Under Our Skin had been made and released without answering an important question: Were the government officials responsible for managing Lyme disease health policy being inappropriately influenced by outside commercial interests?
Through my FOIA request, I found that a majority of the authors of the 2006 IDSA Lyme diagnosis and treatment guidelines held direct or indirect commercial interests related to Lyme disease. By defining the disease and endorsing tests or vaccines for which they were patent holders, they and their institutions made more money.
Yet, now Willy’s confession had added another potential dimension to the story, another reason for the CDC to be undercounting Lyme cases—maybe government officials knew that something else, a pathogen in addition to Borrelia, possibly a bio-weapon, was causing the problems, and they wanted to keep a lid on it. . . .