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Francis Collins: Should M.E. Sufferers Care Whether He Leads the NIH? (Part Two)

Hillary Johnson

A question for people who suffer from M.E. is whether Collins, should he stay, will be helpful to them in the only way he can, by devoting more resources to the disease--by several orders of magnitude--in the form of grants to extramural researchers in academia.  In addition, Collins needs to move the disease out of the broom closet, the Office of Research on Women’s Health, where it has been buried for 18 years, and demand that an appropriate NIH institute take responsibility for it. Given his fondness for huge data sets and broadly-focused, prospective projects that last for years, even decades, my personal view is that it seems unlikely M.E. will ever truly engage Collins' interest unless an academic research team first identifies its cause.  

Thus far, Collins has shown no serious leadership in the M.E. field. His interest in the disease has been limited at best and intermittent, at least publicly.  (If he is attempting to pull strings and pushing to provide funding for the disease behind the scenes, his administrative skills are in question, since any possible efforts he may have made privately have yet to bear fruit.) In 2010, after the discovery of a murine retrovirus in M.E. sufferers, Collins made a brief appearance at the first and only “State of the Knowledge” conference on the topic at NIH.  When the virus, XMRV, was declared a laboratory contaminant two years later, interest in M.E. came to a grinding halt. NIH scientists couldn't seem to run for the exits fast enough, apparently happy to be released from responsibility for studying the nebulous (in their imaginations), hugely tainted M.E.

Several months after the Institute of Medicine issued its report on M.E. early in 2015, Collins paid lip service to the disease in an NIH press release in October.  “Of the many mysterious human illnesses that science has yet to unravel, ME/CFS has proven to be one of the most challenging,” Collins stated. “I am hopeful that renewed research focus will lead us toward identifying the cause of this perplexing and debilitating disease so that new prevention and treatment strategies can be developed.”

One could take the comment at its most superficial level and celebrate that a high-level bureaucrat in the Department of Health and Human Services was acknowledging the disease deserved attention.  But for anyone who has studied the NIH--or the DHHS for that matter--over the years, the statement appeared to be little more than PR word-craft and exactly what one might expect from a well-trained bureaucrat.  Worse was the inclusion of the word "mysterious." The word implies that M.E. is somehow freakishly different from every other disease known to humanity and that although many have tried no one has been able to crack it.  In fact, relatively few have tried, usually with next to no funding.  In fact, a great deal has been discovered about the disease--more than enough to know it is a huge public health crisis that has been unfolding in real time for three decades.  At this late date, there is probably not a doctor left in the U.S. who has failed to see patients with M.E. numerous times in their practice. 

In 2016, the National Institute of Neurological Disorders and Stroke unveiled plans for a five-year in-house clinical study of 40 patients, a time line that is leisurely, at best.  The disease has been spreading for 30 to 35 years and may have already disabled from two to four million Americans. Any selected patients, who must travel to the NIH, will by necessity not be the most seriously afflicted. Further, the knowledge base of the scientists involved seems limited. Published descriptions of their methods suggest the NINDS scientists are mired in a time capsule somewhere in the late-1980s in terms of their grasp of the disease. By the time these investigators actually get going, one can only hope they may be influenced by research underway around the world.

The October 2015 press release from the director's office at NIH noted, in addition, that "NIH will also be considering additional ways to support ME/CFS research in the extramural research community."  For patients who have been sick for decades, the sentence might produce little more than a shrug.  NIH has expressed this sentiment so many times in the last three decades, then failed to deliver, it's not easy to believe it. 

Recently, after anxiously awaiting news of extramural funding, academic M.E. researchers learned that the agency has committed approximately $29 million to M.E.  The catch: it's a sum to be doled out over five years to two or possibly three yet-to-be chosen research centers.  The available funds will amount to about $5 or $6 million a year, depending on the number of centers, and once administrative costs are stripped away from those sums by the institutions, the money will be further diminished.  By report NINDS grant officer Vicky Whittemore, assuredly one of the friendliest, sanest, least defensive members of the NIH staff I've met--someone who is regarded by M.E. researchers and advocates alike as an ally--had to fight hard to secure the money.  That she had to fight at all is doubly discouraging.  Whittemore's struggle suggests Collins is less than excited or personally committed to discovering what has disabled two to four million Americans, 80 percent of them women, for decades. 

As stated in Part One of this series, the NIH project that most excites Collins going forward, by his own admission, is the Precision Medicine Initiative.  The latter seeks to enroll one-million Americans into a data base that will collect medical and demographic information over a period of several years, including their individual genomes.  The Precision Medicine Initiative seems like a great idea in a perfect world: a world where millions of people of every age weren't suffering and eventually dying from a disease that appears to be infectious yet has been shoved to the margins of the government's research agenda since it emerged in the early 1980s.  One thinks of the phrase, "while Rome burns...."  

Tellingly, since news of these centers was announced, two of the most high-profile M.E. research centers of the day, each led by scientists who probably have the best chance of being awarded the parsimonious funds, have made urgent Internet appeals to patients seeking additional donations of money. Ron Davis of Stanford, in an Internet video for patients put together by his public relations team, has said he needs $5 million a year for himself.  This sum would be required, he said, to staff a lab full of competent, out-of-the-box thinkers who would test drugs and theories for years to come.  Columbia University's Center for Infection and Immunity, whose investigators Ian Lipkin and Mady Hornig have conducted research in the past on M.E., went online to plead for donations from patients, too.  Even if Columbia's CII gets an NIH center award, the missive indicated, it still won't be enough unless patients pony up.  

For perspective, single digit figures (one-million, two-million, etc.) are considered so nominal at NIH they are commonly referred to as “fairy dust.”  Additionally, there are currently at least five dedicated centers in the U.S. alone where M.E. is under study by researchers: Cornell, the Nevada Center for Biomedical Research, Nova University, Stanford and Columbia, not to mention the Bateman-Horne Center in Utah and additional collaborative groups.  One might well ask, why not fund all of them to a level commensurate with centers focused on resolving a disease that has caused a public health crisis? Why force these researchers to compete against one another for NIH fairy dust?  Collins either recognizes M.E. as a national emergency, requiring all hands on board, or he doesn't.  If the latter, the latest funding sums look like a political choice. NIH executives can employ their contribution to center grants, however paltry, as a defense if they are ever in the crosshairs of a congressional hearing or forced to testify in a patient's personal injury lawsuit against the DHHS.

Most tragically, many ME patients who fell ill in the 1980s and 1990s are entering their seventh and eighth decades.  Any hope for drug therapies or recovery is rapidly receding in this group, who already may have lost twenty, thirty or more years of their life to M.E.  When you are, say, 65 or 70 years old, news that a study will conclude in five or more years is hardly inspiring. This is especially true if the most likely outcome of the study will be a press release from the NIH noting that M.E. is indeed--in that well-worn phrase--"a real disease."

The tragic nature of the struggle was brought home by long-time patient Johanna Kaiser when she publicly challenged Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke during an NIH call-in three weeks ago. Koroshetz's institute is conducting the too-small, too-late clinical trial. Kaiser noted that most members of her family had perished in the Holocaust; she added that they had all wanted to come to America. 

"If they saw what happened to me (in America) they wouldn't believe it," she added. 

Koroshetz, seemingly at a loss for words, remarked simply, “It’s very sad.”  

A simple, "I'm sorry--mistakes were made," would have hit the mark.  But today's government scientists aren't clued in.  Instead they scratch their heads and ask each other, "Why are these people so mad???" as if the disease itself was a personality disorder defined by excessive anger.  After all, cancer patients aren't angry; MS patients aren't angry; AIDS patients aren't angry--not anymore.

The plight of aging M.E. victims was not sad enough for either Koroshetz or Collins--in whose lap the decision ultimately lay--to cancel speaker Edward Shorter’s lecture to NIH scientists presumably engaged in Koroshetz's clinical trial.  They boldly ignored numerous pleas from patients and their advocates well before the event occurred. Shorter made a name for himself in the 1980s with a book fueled by hate speech characterizing M.E. victims as hysterics who reveled in seeking attention for their fake illness. Going by recent comments to this reporter during an interview last fall, Shorter seems to have grown only more contemptuous of sufferers as he has aged.  Shorter was not cancelled and no apologies were issued. 

Brian Walitt

One of the men who is intricately involved in the M.E. clinical trial, Brian Walitt, referred to Shorter as a “distinguished medical historian” in a scientific publication one month prior the Shorter lecture.  By several indicators too tedious to explore in this space (see my earlier articles on Shorter cached in Eye View Exclusives), it seems most likely that Walitt extended the invitation to Shorter, as much as Walitt's NIH colleagues sought to protect him from being identified as the guilty party.  In my view, if Collins really cared about progress in M.E. and was paying attention, he would have a) demanded Koroshetz dump Walitt from the NINDS clinical investigation or done it himself and b) insisted that Shorter be encouraged to stay in Canada.

Should anyone think the Shorter episode was overplayed by patients, let me suggest it was a metaphor for the NIH's behavior of the last several decades and a startling reminder of how little the government has changed its behavior toward M.E. sufferers since the 1980s. In the weeks leading up to Shorter's appearance, the tone emanating from NIH was a perpetuation of the arrogance that has oozed over and around everything to do with M.E. for years.  It was a reiteration of the unspoken (and sometimes spoken) "We will not let these patients push us around or tell us what to do," a mentality that lasted a couple of years during the early AIDS epidemic but has persisted for 30 years in the case of the M.E. epidemic.

***

Ultimately, Francis Collins is a pleasant man with a relaxed sense of humor who plays electric guitars, rides Harley Davidson motorcycles and is not averse to singing the national anthem at baseball games.  He is also a respected scientist (in part as a result of his directorship of the Genome Project during the 1990s) with an abiding religious faith.  His belief in evolution directed by God’s hand likely holds wide appeal inside an administration whose supporters and their federal representatives, in some unknown but significant portion, believe the earth and all life on it was created in six days.  Whether he will pass muster over the long haul with a president who, thus far, seems perpetually unhinged, is uncertain.  Whether it will make a difference to M.E. sufferers if Collins continues to lead NIH, however, seems highly dubious given his eight years of passivity on the matter.  As Hillary Clinton, quoting Maya Angelou, frequently warned during her presidential campaign in reference to Trump, "When someone shows you who they are, believe them; the first time."

I concede that my low opinion of Collins is not shared by Carol Head and Zaher Nahle, the president and scientific director, respectively, of the Solve ME/CFS Initiative, the L.A.-based research and advocacy organization that I wrote about in this space in January.  In their latest bulletin, they, too, address the issues of regime change at NIH:

"Dr. Collins has been one of the most effective directors to date in moving the internal processes of the NIH toward progress for ME/CFS. However, the new administration also presents new challenges. The ME/CFS advocacy community has spent eight years cultivating agency relationships to make progress, and the potential to lose those small gains is very real. Furthermore, the nominee for secretary of the Department of Health and Human Services (HHS), Senator Tom Price, has spurned constituents with ME/CFS who have approached him in the past. SMCI will work actively with the incoming administration to educate and inspire action regarding ME/CFS. Ultimately, it is not the administration that will dictate the future of ME/CFS, but advocacy."

Maybe you have to be someone who has had 31 years of their life, two-thirds of their adulthood, stolen from them as a result of incompetence, bias and corruption at NIH and throughout the rest of the federal health establishment to hold the director of the NIH to a higher standard.  Lip service is neither action nor leadership.  Collins may have been "one of the most effective leaders to date in moving the internal processes of NIH toward progress for ME/CFS," but I would add, compared to what? 

An effective leader would have insured that M.E. had been pulled from the Office if Research on Women's Health; would have made sure the proposed funding of M.E. centers of expertise included all the M.E. centers instead of forcing investigators with expertise and specific research interests to compete for amounts of money that are so  inadequate as to be laughable. An effective leader would have made public comments--to journalists with large audiences--about the urgency of the M.E. crisis and the seriousness of the disease in order to counteract the stigma that continues to exist and impedes progress.  

Finally, an effective leader would have found the time to apologize to M.E. sufferers for the devastating failures of the past three decades at NIH to resolve the disease. 

In 1997, President Bill Clinton apologized in the East Room of the White House to the eight survivors of the Tuskegee syphilis experiments undertaken by the Centers for Disease Control from the 1930s to the 1970s.  He called the CDC's activity the "longest nontherapeutic experiment on human beings" in public health history.  Anyone who has read Osler's Web, or who knows even some of the government's history surrounding M.E., can see the parallels and grasps the need for public apology.  NIH should probably be on notice that patient trust and confidence in anything the NIH does will be undermined until that apology comes.  The past must be acknowledged.  Until everyone who remembers it has died and Osler's Web begins to disappear from library shelves, the decades of inhumanity toward sufferers of M.E. and illegal activities with respect to the investigatory process will taint whatever NIH tries to do. 

‍Certainly thirty years of inaction leads to gratitude for anyone who will even listen to patients or their representatives and express concern.  The phenomenon seems uncomfortably close to the Stockholm syndrome to me, however. I believe Head and Nahle are doing the best they can with a largely unresponsive federal agency.  They were able to "buttonhole" Collins at a public meeting to discuss ME in 2016.  In effect, the NIH director listened to these highly motivated representatives of thousands of patients on the fly.  To my knowledge, Collins has scheduled no meetings with Head and Nahle, nor with any members of congress who have shown support for the disease, to discuss strategies for addressing an epidemic that has disabled millions in this country alone.

Head and Nahle also point out that Trump's new Secretary of Health, Tom Price, has actually "...spurned constituents with ME/CFS who have approached him in the past."  Their observation is a chilling omen of what may be in store no matter who heads the NIH.  Price has so many black marks against him, including his place in the so-called Republican War on Women, it's difficult to imagine he will be receptive to turning significant resources toward M.E.   Head and Nahle's final comment on the matter of regime change that "advocacy will dictate the future of ME," not any particular group of high-level bureaucrats in the administration, seems not just realistic but profound.

The abuse and neglect of PWME has been ongoing within NIH since Stephen Straus debuted his psychoneurotic theory of the disease 25 years ago.  Straus also advised the Food and Drug Administration in their deliberations on Ampligen--resulting in a failure to approve the drug despite the fact that it works and is safe.  Straus gave permission to doctors in hospitals and medical schools to laugh at patients and the disease in his grand rounds lectures throughout the 1990s.  I was in the audience copying his jokes into my notebook, weighing the laughter, when he did so.  National Institutes of Allergy and Infectious Diseases director Anthony Fauci, Straus’ biggest cheerleader, remains in place as possibly the most powerful player at NIH (he has held his post since Reagan's first term, and unlike the director, does not serve "at the pleasure of the president").  I have heard that Fauci is the third-highest paid employee in the federal health system.  He continues to show M.E. the back of his hand, last year telling Carol Head and Ellen Clayton Wright, chair of the IOM investigation of M.E., that M.E. will not find a home at NIAID. 

Lastly, Trump’s desire for increased military spending and significantly reduced funding to regulatory agencies and so-called “entitlements”—not to mention his administration’s communal desire to limit and even deny women’s access to health care and to punish women who attempt to claim ownership of their own bodies, is deeply worrisome.  The new president's agenda suggests that money for a stigmatized, wildly politicized disease, suffered by women by a ratio of 4 or 5 to one, may continue to be scarce no matter who is running NIH absent outside intervention, whether in the form of class action law suits or Congressional hearings. 

 

Post Script:  Trump and Vaccines

 

When Collins submitted his resignation on December 7 of last year, so did the CDC’s director Tom Friedan, a former NYC Health Commissioner.  Like Collins, Frieden was appointed by Obama in 2009. The Trump administration accepted his resignation and Friedan’s deputy, Anne Schuchat, a CDC veteran of 30 years, became acting director. 

Schuchat, who began her CDC career as an Epidemic Intelligence Service officer, would have been a contemporary of Gary Holmes, then an EIS officer who investigated the 1984-1985 Incline Village outbreak for the agency.  Is it possible Schuchat avoided being tainted by the contempt for M.E. and its sufferers that pervaded (and which I amply documented in real time) the CDC of that era? 

Friedan, of course, wasn't at the CDC during that era.  Nonetheless, the CDC head to my knowledge never publicly uttered the words “myalgic encephalomyelitis” or “chronic fatigue syndrome” during his tenure, which happens to have been the second-longest in CDC history.  Frieden responded aggressively to the Zika virus outbreak, persuading Congress to devote over one billion dollars to fight Zika.  His response to the Ebola outbreak was marred, however, in the view of many.  He was accused of being “out of touch” and unprepared. Since departing the CDC, Friedan has told the press that going forward he plans to take whatever job will allow him “to save the most lives.”

In an article on the Daily Kos site, Friedan has been described as being dismissive of anti-vaccine proponents. The anonymous author of the piece speculated that Friedan’s opposition to the anti-vaccination movement possibly cost him his job given Trump’s stated interest in exploring vaccination safety. More likely, Freidan is simply following the pattern of most CDC heads who exit the job when a new president is elected.  There have been seven CDC directors since the M.E. outbreak began to be written about in the scientific literature in the early 1980s, and six presidents.

Robert Kennedy, Jr.

The vaccine issue, nevertheless, could derail Collins.  Donald Trump has expressed his concern about the current vaccine schedule for infants.  Trump feels strongly enough about the issue that he has sought out Robert Kennedy, Jr. to possibly establish a vaccine safety commission.  A rumor persists that Trump's youngest son Barron may be autistic. The well-connected, dogged Kennedy has performed extensive investigation into the Centers for Disease Control’s vaccine research.  Kennedy has accused the agency of hiding data about vaccine safety in Rolling Stone magazine and elsewhere.  As recently as February 21, 2017 Kennedy and actor Robert DeNiro held a press conference in which they offered $100,000 to anyone who could prove that the presence of mercury in children’s vaccines was safe.

Short of committing his institute to supporting an exploration of vaccine safety, Collins may truly be a placeholder deputy should Trump make the vaccine controversy a litmus test. On the other hand, Collins may prevail simply on the strength of his born-again bona fides and his merging of biblical passages with his belief in evolution.

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