Trump’s COVID-19 Case Exposes Inequalities in the Healthcare System

Early Friday morning (October 2, 2020) President Trump announced through Twitter that he had tested positive for COVID-19 (aka SARS-CoV-2). Later Friday afternoon he was whisked away by helicopter for a 10-minute ride to Walter Reed National Military Medical Center (WRNMMC, formerly Bethesda Naval Medical Center) which is across the street from the National Institutes of Health campus in Bethesda. There he received REGN-COV2, a combination of two monoclonal antibodies (REGN10933 and REGN10987) directed against the spike protein of the COVID-19 virus. In addition, he received a dose of remdesivir (an antiviral drug) as well as zinc, vitamin D, famotidine (Pepcid®), melatonin and aspirin. As of Saturday morning, Trump has done well by all accounts.

All the therapies administered to Trump are unproven but have some evidence supporting their use against COVID-19. The Trump administration issued an emergency use authorization for remdesivir earlier this year after the drug showed moderate effectiveness in improving outcomes for patients who were hospitalized with the coronavirus (1). REGN-COV2 is now in Phase 3 clinical trials, is still experimental and has not received emergency use approval from the FDA. However, it had sufficient evidence for President Trump to receive the drug in response to a compassionate use request to the manufacturer (2). There is also some evidence that the other ancillary therapies might be useful therapies against COVID-19 (3-7).

What these therapies have in common is that the available scientific evidence of their efficacy was funded, at least in part, by the US government, most prominently the FDA’s Coronavirus Treatment Acceleration Program (CTAP) (8). The US government has spent several billion dollars on COVID-19 therapies including $450 million on REGN-COV2 and at least $75 million for remdesivir (9,10). The success of the program is remarkable in light of the disbanding of the National Security Council pandemic unit which had predicted the disaster we are now enduring (11). The ingenuity of the scientific community is truly amazing when motivated by billions of dollars. Those Americans who actually pay taxes should be proud of their government officials for making such successful investments on their behalf.

President Trump’s care is in contrast to my own or the general public. I recently became ill with increasing shortness of breath, orthopnea and a nonproductive cough but no fever. Because I have a history of diastolic dysfunction, I had assumed this was heart failure. As a physician who has many friends in the medical community, I am privileged to be able to call my cardiologist who saw me later that day. The general public might well have had to accept his next available appointment which was over 3 months or go to an emergency room. After 2 days, and 5 trips to a free-standing radiology center and 2 trips to a laboratory testing site, it became clear that I had left lower pneumonia by chest-x-ray and a normal brain naturetic peptide. Later that day I went to a free-standing clinic and had a rapid COVID-19 test which was negative. Because my presentation was atypical for bacterial pneumonia, I called my pulmonary physician who also saw me later that day. He ordered a coccioidomycosis serology and a COVID-19 test by PCR. The former because of the high possibility of Valley Fever which can cause up to a third of community-acquired pneumonias in Arizona and the latter because of the poor sensitivity of the rapid COVID-19 antibody test (12,13). However, I was not able to schedule the collection of the nasal swab or blood for 10 days at a free-standing laboratory. This seems excessively long and my pulmonologist decided against empirical treatment for Valley Fever because of a potential drug interaction with one of my heart medications (dofetilide).

President Trump often brags that the US has the greatest healthcare system in the world and for him it is. Although he repeatedly touted ineffective therapies for COVID-19 such as hydroxychloroquine, bleach and light and belittled those who wore masks, when he got sick only scientifically based therapy was used despite the expense (14). The general public probably does not have President Trump’s or my access to physicians. Donald Trump, the White House staff, and some professional athletes are getting daily COVID-19 tests but the rest of us taxpayers are forced to wait 10 days to get a nasal swab and a blood sample drawn.

USA Today is now reporting that President Trump had earned capital gains from Regeneron Pharmaceuticals and Gilead Sciences, the manufacturers of REGN-COV2 and remdesivir (15). According to a 2017 financial disclosure form filed with the U.S. Office of Government Ethics in June 2017, Trump had a capital gain of $50,001 to $100,000 for Regeneron Pharmaceuticals and $100,001 to $1 million for Gilead. Trump’s subsequent disclosure forms, including his 2020 form signed July 31, did not list Regeneron or Gilead. Ostensibly, he, other family members and close associates sold their stocks to avoid any apparent conflict of interest.

Based on previous experience, I remain skeptical that therapies developed and distributed by our tax monies will really be free. Will the clever businessmen who run drug companies take money from the US government for product development and then bill a hefty sum for their product? Will the rush to develop a vaccine before the November elections put expediency over safety? Some vaccines rushed to market such as the polio vaccine of 1955 or the swine flu vaccine of 1976 resulted in serious side effects in some recipients (16). As Trump is so fond of saying, “We will have to wait and see”.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. FDA. COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19. August 28, 2020. Available at: https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized#:~:text=Today%2C%20as%20part%20of%20its,laboratory%2Dconfirmed%20COVID%2D19%2C (accessed 10/3/20).
2. Farr C, Stankiewicz K. Here’s everything we know about the unapproved antibody drug Trump took to combat coronavirus. CNBC. October 2, 2020. Available at: https://www.cnbc.com/2020/10/02/what-we-know-about-regeneron-antibody-drug-trump-took-to-combat-coronavirus.html (accessed 10/3/20).
3. Arentz S, Yang G, Goldenberg J, et al. Clinical significance summary: Preliminary results of a rapid review of zinc for the prevention and treatment of SARS-CoV-2 and other acute viral respiratory infections [published online ahead of print, 2020 Aug 1]. Adv Integr Med. 2020;10.1016/j.aimed.2020.07.009. [CrossRef] [PubMed]
4. Entrenas Castillo M, Entrenas Costa LM, Vaquero Barrios JM, Alcalá Díaz JF, López Miranda J, Bouillon R, Quesada Gomez JM. "Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study". J Steroid Biochem Mol Biol. 2020 Oct;203:105751. [CrossRef] [PubMed]
5. Freedberg DE, Conigliaro J, Wang TC, Tracey KJ, Callahan MV, Abrams JA; Famotidine Research Group. Famotidine Use Is Associated With Improved Clinical Outcomes in Hospitalized COVID-19 Patients: A Propensity Score Matched Retrospective Cohort Study. Gastroenterology. 2020 Sep;159(3):1129-1131.e3. [CrossRef] [PubMed]
6. Zhang R, Wang X, Ni L, et al. COVID-19: Melatonin as a potential adjuvant treatment. Life Sci. 2020;250:117583. [CrossRef] [PubMed]
7. Mohamed-Hussein AAR, Aly KME, Ibrahim MAA. Should aspirin be used for prophylaxis of COVID-19-induced coagulopathy? Med Hypotheses. 2020 Jun 8;144:109975. [CrossRef] [PubMed]
8. FDA. Coronavirus Treatment Acceleration Program (CTAP). Available at: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap (accessed 10/3/20).
9. Loftus P, Walker J.  U.S. Commits $2 Billion for Covid-19 Vaccine, Drug Supplies. Wall Street Journal. July 7, 2020. Available at: https://www.wsj.com/articles/u-s-commits-2-billion-for-covid-19-vaccine-drug-supplies-11594132175 (accessed 10/3/20).
10. Public Citizen. The Public Already Has Paid for Remdesivir. Available at: https://www.citizen.org/news/the-public-already-has-paid-for-remdesivir/ (accessed 10/3/20).
11. Riechmann D. Trump disbanded NSC pandemic unit that experts had praised. AP News. March 14, 2020. Available at: https://apnews.com/article/ce014d94b64e98b7203b873e56f80e9a (accessed 10/3/20).
12. Valdivia L, Nix D, Wright M, Lindberg E, Fagan T, Lieberman D, et al. Coccidioidomycosis as a common cause of community-acquired pneumonia. Emerg Infect Dis. 2006;12(6):958-62. [CrossRef] [Pubmed]
13. Guglielmi G. Fast coronavirus tests: what they can and can't do. Nature. 2020 Sep;585(7826):496-498. [CrossRef] [PubMed]
14. Robbins RA. Lack of natural scientific ability. Southwest J Pulm Crit Care. 2020;21(1):15-22. [CrossRef]
15. Tyko K. Trump COVID-19 treatment: President had stakes in Regeneron and Gilead, makers of antibody cocktail, Remdesivir. USA Today. October 3, 2020. Available at: https://www.usatoday.com/story/money/2020/10/03/trump-walter-reed-treatment-president-regeneron-gilead-remdesivir/3610111001/ (accessed 10/3/20).
16. Trogen B, Oshinsky D, Caplan A. Adverse Consequences of Rushing a SARS-CoV-2 Vaccine: Implications for Public Trust. JAMA. 2020 Jun 23;323(24):2460-2461. [CrossRef] [PubMed]

Cite as: Robbins RA. Trump’s COVID-19 Case Exposes Inequalities in the Healthcare System. Southwest J Pulm Crit Care. 2020;21(4):82-5. doi: https://doi.org/10.13175/swjpcc055-20 PDF 

Brenda Fitzgerald, Conflict of Interest and Physician Leadership

Barely noticed in the news last week was Brenda Fitzgerald’s resignation as director of the Centers for Disease Control (CDC) after only 6 months on the job (1). Her resignation came one day after Politico reported that she bought shares in a tobacco company one month after assuming the CDC directorship (2). The stock was one of about a dozen new investments that also included Merck and Bayer (3). Fitzgerald had come under criticism by Senator Patty Murray for slow walking divestment from older holdings that government officials said posed potential conflicts of interest (1). While serving as director of the Georgia Department of Health, Fitzgerald owned stock in five other tobacco companies: Reynolds American, British American Tobacco, Imperial Brands, Philip Morris International, and Altria Group (4).

“It gives you a window, I think, into her value system,” said Kathleen Clark, a professor of law focusing on government ethics at Washington University in St. Louis (2). “It doesn’t make her a criminal, but it does raise the question of what are her commitments? What are her values, and are they consistent with this government agency that is dedicated to the public health? Frankly, she loses some credibility.” Purchasing tobacco stocks by any physician is disturbing, even more so when done by the director of the agency that spearheads the US government’s efforts to reduce smoking.

The influence of money on healthcare legislation has become increasingly concerning. Merck, whose stock Fitzgerald purchased on August 9, has been working on developing an Ebola vaccine and also makes HIV medications (2,3). Bayer, whose stock she purchased on August 10, has in the past partnered with the CDC Foundation to prevent the spread of the Zika virus (2,3). Fitzgerald’s purchases of tobacco stocks represent just one more instance of a potentially inappropriate relationship between politicians and business. Previous research published in the Southwest Journal of Pulmonary and Critical Care (SWJPCC) demonstrated a correlation between tobacco company political action committee contributions and support of pro-tobacco legislation (5).

Fitzgerald’s ethics issues are apart from a broader assessment of her leadership at the CDC. She had no research experience while leading an organization where research is one of its primary functions. She had previously promoted anti-aging medications to her patients despite no evidence of their efficacy (6).  She made few public statements during her time at the CDC and waited 133 days before holding her first staff meeting. She was scheduled several times to testify before Congress but sent deputies instead.

Fitzgerald seems to represent a high-profile version of the obsequious physician executive (OPIE), i.e., a physician obedient or attentive to an excessive or servile degree (7). Like the OPIE at the local hospital, Fitzgerald may have been appointed not for skill as a leader but her compliance as a subordinate to her supervisors. It raises the question of who would want to be director of the CDC when the current administration has been openly hostile, targeting the agency for deep budget cuts.

Hopefully, the next director of the CDC will be less conflicted. Previously, the SWJPCC has published tobacco company PAC contributions to candidates for political office (5). At the request of the Arizona Thoracic Society we intend to do the same prior to the November 2018 elections (8). In the interim, you can check tobacco company PAC contributions to federal candidates on the Campaign for Tobacco Free Kids website or for contributions at the state level at followthemoney.org (9,10).

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Sun LJ. CDC director resigns because of conflicts over financial interests. Washington Post. January 31, 2018. Available at: https://www.washingtonpost.com/news/to-your-health/wp/2018/01/31/cdc-director-resigns-because-of-conflicts-over-financial-interests/?utm_term=.05ee75769108 (accessed 2/3/18).
2. Karlin-Smith S, Ehley B. Trump's top health official traded tobacco stock while leading anti-smoking efforts. Politico. January 30, 2018. Available at: https://www.politico.com/story/2018/01/30/cdc-director-tobacco-stocks-after-appointment-316245 (accessed 2/3/18).
3. Fitzgerald B. Periodic Transaction Report | U.S. Office of Government Ethics; 5 C.F.R. part 2634 Executive Branch Personnel Public Financial Disclosure Report: Periodic Transaction Report (OGE Form 278-T). Revised 12/21/17. Available at: https://www.politico.com/f/?id=00000161-4804-d9fe-a9fd-5af5834d0000 (accessed 2/3/18).
4. Fitzgerald B. Executive Branch Personnel Public Financial Disclosure Report (OGE Form 278e). Revised 10/12/17. Available at:  https://www.politico.com/f/?id=00000161-4867-da2c-a963-cf770b6b0000 (accessed 2/3/18).
5. Robbins RA. Tobacco company campaign contributions and congressional support of the cigar bill. Southwest J Pulm Crit Care. 2016;13(4):187-90. [CrossRef]
6. Levitz E. Trump’s CDC pick peddled ‘anti-aging’ medicine to her gynecologic patients. New York Magazine. July 10, 2017. Available at: http://nymag.com/daily/intelligencer/2017/07/trumps-cdc-pick-peddled-anti-aging-medicine-to-patients.html (accessed 2/3/18).
7. Robbins RA. Beware the obsequious physician executive (OPIE) but embrace dyad leadership. Southwest J Pulm Crit Care. 2017;15(4):151-3. [CrossRef]
8. Robbins RA. September 2017 Arizona thoracic society notes. Southwest J Pulm Crit Care. 2017;15(3):122-4. [CrossRef]
9. Campaign for Tobacco Free Kids. Tobacco PAC contributions to federal candidates. Available at: https://www.tobaccofreekids.org/what-we-do/us/tobacco-campaign-contributions (accessed 2/3/18).
10. The National Institute on Money in State Politics. Money in state politics. Available at: https://www.followthemoney.org/tools/election-overview/?s=AZ&y=2016 (accessed 2/3/18).

Cite as: Robbins RA. Brenda Fitzgerald, conflict of interest and physician leadership. Southwest J Pulm Crit Care. 2018;16(2):83-5. doi: https://doi.org/10.13175/swjpcc029-18 PDF 

Disclosures for All

The August 15 edition of the Annals of Internal Medicine published an article “Effect of Access to an Electronic Medical Resource on Performance Characteristics of a Certification Examination - Randomized Controlled Trial" (1). The study examined open book vs. closed book testing for the American Board of Internal Medicine (ABIM) examination and found no or minimal changes in the outcomes between the two testing conditions.

All in all, this is not very exciting. However, what is interesting is a blog on the article written by Westby G. Fisher, MD in his Dr. Wes blog (2). He examined the disclosures from the Annals editors of the article who claimed no financial relationships or interests to disclose. However, Fisher points out that on its last available Form 990, the publishers of the Annals of Internal Medicine, the American College of Physicians (ACP), earned over $24.6 million in a single year selling their Medical Knowledge Self-Assessment Program to US physicians to study for their board certification and recertification examinations (3). Furthermore, Fisher notes that an accompanying editorial written by ACP's former senior executive vice president, Steven E. Weinberger, MD, a pulmonologist and an employee of the ACP, also did not disclose any meaningful conflicts. However, with compensation of nearly $800,000 in 2014, Weinberger’s compensation was over 3 times the average compensation of pulmonolgists in the Middle Atlantic states of $226,000 (3,4). It seems unlikely that unless their financial status was healthy that the ACP could have afforded a luxury such as Dr. Weinberger.

Fisher notes that the study was conceived exclusively by the American Board of Internal Medicine and executed by their corporate partners at PearsonVue and Wolters Kluwer. However, PearsonVue had more than a minor role in the research and had access to the study registrants' names, addresses, and probably more (2). Each of the 825 physicians enrolled in the study received $250 from the ABIM Foundation. None of the participants were told about the financial benefits to the ABIM, PearsonVue, Wolters Kluwer, or their content creators for participation in this study.

The financial future of many of the 24 approved medical specialty boards of the American Board of Medical Specialties (ABMS) and the 18 approved medical specialty boards of the American Osteopathic Association (AOA) was in doubt until maintenance of certification (MOC) was conceived back in the 1980’s (2). Since then there have been multiple attempts to show MOC leads to better patient outcomes, but to my knowledge, no meaningful improvements have been shown (5-7). Furthermore, advertising for MOC programs with slogans such as “Is your doctor board-certified?” likely led to an erosion of faith in the medical profession. These MOC programs can largely be lumped with other money-making schemes such as continuing medical education and hospital recertification which are funded on the backs of physicians, are time-consuming and have not been shown to improve care.

According to Fisher (2), “conflicted research” as published in the Annals of Internal Medicine misleads the public and represents little more than a free advertising for the financial agendas of MOC organizations who benefit from the research. Furthermore, “…it sets and incredibly low (and untrustworthy) bar for all of academic publishing.”

Although this is strong language, Fisher is right. Disclosures need to be full and honest from all. Here are ours. The cost of the Southwest Journal of Pulmonary and Critical Care (SWJPCC) is funded by the non-profit Phoenix Pulmonary and Critical Care Research and Education Foundation. None of the foundation board of directors, the editors, associate editors, staff, reviewers or authors receive any compensation. Our operating expenses are less than $5000/year and our income is dependent on donations to our foundation. We hope this reassures our readers that we have no hidden agenda and that what they read in the SWJPCC is honestly reviewed.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Lipner RS, Brossman BG, Samonte KM, Durning SJ. Effect of Access to an Electronic Medical Resource on Performance Characteristics of a Certification Examination: A Randomized Controlled Trial. Ann Intern Med. 2017 Aug 15 [Epub ahead of print]. [CrossRef] [PubMed]
2. Fisher WG. Fake news: Annals of Internal Medicine's disclosures. Dr. Wes. August 16, 2017. Available at: http://drwes.blogspot.com/2017/08/fake-news-annals-of-internal-medicines.html (accessed 8/17/17).
3. CitizenAudit.org. American College of Physicians Form 990. 2014. Available at: http://pdfs.citizenaudit.org/2015_05_EO/23-1520302_990_201406.pdf (accessed 8/17/17).
4. Peckham C. Medscape pulmonologist compensation report 2014. Medscape. April 15, 2014. Available at: http://www.medscape.com/features/slideshow/compensation/2014/pulmonarymedicine (accessed 8/17/17).
5. Buscemi D, Wang H, Phy M, Nugent K. Maintenance of certification in Internal Medicine: participation rates and patient outcomes. J Community Hosp Intern Med Perspect. 2013 Jan 7;2(4). [CrossRef] [PubMed]
6. Hayes J, Jackson JL, McNutt GM, Hertz BJ, Ryan JJ, Pawlikowski SA.Association between physician time-unlimited vs time-limited internal medicine board certification and ambulatory patient care quality. JAMA. 2014 Dec 10;312(22):2358-63. [CrossRef] [PubMed] 
7. Gray BM, Vandergrift JL, Johnston MM, Reschovsky JD, Lynn LA, Holmboe ES, McCullough JS, Lipner RS. Association between imposition of a Maintenance of Certification requirement and ambulatory care-sensitive hospitalizations and health care costs. JAMA. 2014 Dec 10;312(22):2348-57. [CrossRef] [PubMed] 

Cite as: Robbins RA. Disclosures for all. Southwest J Pulm Crit Care. 2017;15(2):87-9. doi: https://doi.org/10.13175/swjpcc105-17 PDF 

Qualitygate: The Quality Movement's First Scandal

Charles R. Denham is probably not a name familiar to most of our readers. Denham's name popped into the news when the Justice Department alleged that CareFusion, then a division of Cardinal Healthcare, paid Denham $11.6 million to influence the Safe Practices Committee at the National Quality Forum (NQF).

Dr. Charles R. Denham

Even though Denham may not be well known, readers might recognize the names of some of the organizations and individuals with whom Denham worked (2,3). Besides the NQF, these include the Institute of Medicine, Leapfrog Group, Centers for Disease Control and Prevention, Clinton Global Health Initiative, Discovery Channel, General Electric, Cleveland Clinic, Vanderbilt University Medical Center, Catholic Healthcare Partners, and Seton Medical Center. Prominent individuals associated with Denham include actor Dennis Quaid (whose newborn twins were nearly killed by a medication mistake) and Capt. Chesley "Sully" Sullenberger, famous for safely landing a crippled jetliner in the Hudson River. Lesser known, but prominent in the patient safety movement, are Dr. Kenneth Kizer (former Under Secretary for Health in the U.S. Department of Veterans Affairs and founding president and former CEO of the NQF) and Dr. Donald Berwick (founder and former President of the Institute of Healthcare Improvement and former Administrator of the Centers for Medicare and Medicaid Services).

Denham is a member of the President's Circle of the National Academies of Science of the Institute of Medicine, the National Academy of Sciences and the National Academy of Engineering. He has been a Senior Fellow in the Advanced Leadership Initiative at Harvard University and instructor at the Harvard School of Public Health. He teaches leadership and innovation on the faculty of Harvard Medical School and was an adjunct Professor at the Mayo Clinic College of Medicine. He played a leadership role in the development of a computerized prescriber order entry (CPOE) simulator that measures performance improvement of hospital medication management systems, driving patient safety through healthcare information technologies. He founded CareMoms, CareKids, and CareUniversity, which are programs that are focused on helping families survive healthcare harm and waste. He was until very recently the editor of the Journal of Patient Safety (4).

Many groups have benefitted by recommending best practices, but an endorsement by the NQF can mean riches for companies and individuals (4). Created in 1999 at the behest of a Presidential commission, the Washington, D.C.-based nonprofit takes private donations and collects fees from members, including consumer groups, health plans and medical providers. Five years ago, Health and Human Services hired the NQF to endorse measures to show whether health care spending is achieving value for patients and taxpayers. The contract has since grown substantially and by 2012 made up nearly three-fourths of the organization’s $26 million in revenue. The NQF’s standards are widely adopted. The report produced by the committee Denham co-chaired included recommendations for best practices in 34 areas of care.

The quality movement is distancing itself from Denham and denying any knowledge of Denham's conflicts of interest or alleged kickbacks (5). However, there were multiple clues. Although Denham was trained as a radiation oncologist, he was not a practicing physician (6). Known as an entrepreneur, Denham had formed and folded numerous for-profit and non-profit companies. Those listed by the Texas Secretary of State’s office include the Texas Institute of Medical Technology; Health Care Concepts; TD Enterprises Management; Spectrum Holdings International (also known as Austin Liberty, Inc.); Tetelestai, Inc. (Greek for “It is finished,” a New Testament reference); Aircare International, Inc. (Denham at one time worked in the aviation industry); CRD Health Ventures, Inc.; and Assisted Better Living Everywhere, Inc. Denham and his family live in a palatial waterfront home in Laguna Beach, California, whose value Zillow estimates at $10.5 million (6). The speaker’s bureau lists Denham’s minimum fee for U.S. engagements as an average of $50,000 to $75,000, far in excess of usual physician speaking fees (6). Denham even boasted his own webpage on Wikipedia and had a contract with Celebrity Talent International (2,4). Although Denham's biography in Wikipedia claims over 100 scientific publications a quick check of PubMed reveals only 25 with nearly all published in the last 5 years in the Journal of Patient Safety where Denham was editor.

In his article in Forbes, Michael Millenson quotes an accomplished patient safety advocate who left her first meeting with Denham convinced she had met with one of the most brilliant individuals of her life (4). Those who know Denham suspect that he would agree (6). The tendency of very smart and successful individuals to boss others is well known because in their own minds they are smarter and better, even when the evidence says otherwise. Some can even blur the boundaries between what they have done, what they are doing and what they hope to do-convincing themselves that it is in the patients' best interests. Like Watergate did to the Nixon White House, Denham has tainted many in the quality movement. Hence the title of this editorial-"Qualitygate". A lot of money is involved in patient safety and there are undoubtedly some willing to sacrifice principles for personal gain. This will probably not be the last scandal in the quality movement. As we have noted previously, there are probably too many guidelines based on expert opinion and some are wrong (7). Physicians need to exercise their own best judgment in deciding which guidelines need to be implemented.

Richard A. Robbins, MD*

Editor

Southwest Journal of Pulmonary and Critical Care

References

1. Department of Justice Office of Public Affairs. CareFusion to pay the government $40.1 million to resolve allegations that include more than $11 million in kickbacks to one doctor". Available at: http://www.justice.gov/opa/pr/2014/January/14-civ-021.html (accessed 2/21/14).
2. Wikipedia. Charles Denham. Available at: http://en.wikipedia.org/wiki/Charles_Denham (accessed 2/21/14). 
3. Newswise. Dr. Charles Denham named editor of Journal of Patient Safety. Available at: http://www.newswise.com/articles/dr-charles-denham-named-editor-of-journal-of-patient-safety (accessed 2/21/14).
4. Allen M. Hidden financial ties rattle top health quality group. Propublica. Available at: http://www.propublica.org/article/hidden-financial-ties-rattle-top-health-quality-group (accessed 2/21/14).
5. Carlson J. Groups cut ties to Denham. Modern Healthcare. Available at: http://www.modernhealthcare.com/article/20140201/MAGAZINE/302019962 (accessed 2/21/14). 
6. Millenson M. The money, the MD and a $12 million patient safety scandal. Forbes. Available at: http://www.forbes.com/sites/michaelmillenson/2014/02/14/the-money-the-md-and-a-12-million-patient-safety-scandal/ (accessed 2/21/14).
7. Robbins RA. What's wrong with expert opinion? Southwest J Pulm Crit Care. 2014;8(1):71-3. [CrossRef]

*The views expressed are those of the author and do not necessarily represent the views of the Arizona, New Mexico, Colorado or California Thoracic Societies or the Mayo Clinic.

Reference as: Robbins RA. Qualitygate: the quality movement's first scandal. Southwest J Pulm Crit Care. 2014;8(2):132-4. doi: http://dx.doi.org/10.13175/swjpcc022-14 PDF

What's Wrong with Expert Opinion?

In this month's Pulmonary Journal Club Dr. Mathew reviews an article by Feuerstein et al. (1) from Beth Israel Deaconess Medical Center and Harvard Medical School published in the Mayo Clinic Proceedings (2). The authors reviewed  the evidence basis for 153 interventional guidelines including 2 from the American College of Chest Physicians and the American Thoracic Society. Of the 3425 recommendations reviewed, 11% were supported by level A evidence, 42% by level B, and 48% by level C. These numbers are very close to the results published by Lee and Vielemeyer (3) for the Infectious Disease Society of America guidelines where only 14% of the guidelines were based on level A evidence and 55% by level C.

So what's wrong with the majority of guidelines based on expert opinion? After all, these are experts in the field and it can be argued that most of these opinions are probably right and that physicians want guidance from the experts. The problem is that they are opinion and sometimes wrong. When they are wrong the potential exists for causing large and devastating harm to patients. This has become an increasingly frequent. As examples:

1. Tight control of glucose in the intensive care unit which according to the largest and best done multi-center trial, causes a 14% increase in ICU mortality (4).
2. Xigris (activated protein C) for adults with septic shock which caused an increase in bleeding and a small but insignificant increase in mortality leading to withdrawal of the drug (5).
3. Perioperative beta blockers which Cole and Francis calculated caused an excess mortality of 800,000 deaths in Europe over the past 5 years (6).
4. Fluid boluses for in African children with severe infection which caused a 49% increase in mortality (7).

Guideline interventions leading to a decrease in mortality are rare and there are no carefully-done, randomized trials of guidelines that have shown a 14% decrease in mortality in the ICU, saved 800,000 lives or improved mortality by 49% in severe infection. So the question arises why were these guidelines put in place, and in some cases, why do they persist? In an editorial which was to be published on January 21 in the European Heart Journal, Cole and Francis raised the possibility that the responsibility for misconduct lies not just with misguided researchers but also the institutions and the institutional leaders that provide uncritical support to research factories. Further, they discussed the role of journal editors and, even, journal readers. However, the two editorials were withdrawn about an hour after the first was published.

It appears that some guidelines have become a cesspool of conflicts of interest (COI). As pointed out in the article Dr. Mathew reviewed, 62% of the guidelines failed to comment on COIs; when disclosed, 91% of guidelines reported COIs. In a egregious example of COI influencing guidelines, the research done by Don Poldermans on perioperative beta blockers has been discredited and he has been dismissed from his university (6). Poldermans also chaired the guideline writing committee for the European Society of Cardiology on perioperative beta blockers. The previously mentioned editorials by Cole and Francis discussing Poldermans' research and its implications were retracted by the European Heart Journal. Why the journal chose to retract the editorials is unclear but one wonders if threats of loss of advertising or lawsuits from pharmaceutical company lawyers may have had something to do with it.

The story of Xigris is a further example of COIs gone amuck (8,9). Eli Lilly, the manufacturer of Xigris, provided a $1.8 million grant to fund a task force on “Values, Ethics and Rationing in Critical Care” reportedly to further the concept that it was unethical to withhold Xigris from septic patients. Eli Lilly provided over 90% of the funding for The Surviving Sepsis Campaign, launched in October 2002 to create guidelines for the treatment of sepsis.  Many of the international experts who formulated the recommendations of this group had significant outside financial relationships with Eli Lilly. As subsequent prospective trials began to raise important concerns regarding the safety and efficacy of Xigris, these concerns were repeatedly and conspicuously absent from published recommendations of the Surviving Sepsis campaign. In 2004, Eli Lilly started a program of offering unrestricted grants to institutions for implementing Surviving Sepsis Campaign patient management bundles.

The leaders in healthcare from the Institute of Healthcare Improvement (IHI) to the local leaders often have substantial COIs combined with a weak backgrounds in medicine and research. For example, the evidence basis for IHI's 100,000 Lives Campaign was weak (10). However, the non-peer reviewed press releases allowed IHI to receive a landslide of “brand recognition” which undoubtedly led to substantial new revenues and philanthropic dollars (10). Locally, many CEOs and managers are operating under incentive systems that tie bonuses to guideline compliance. One chairman of medicine, asked me, "Why is my bonus tied to how many pneumococcal vaccines are administered?". Others may not be so willing to question the hand that feeds them.

It is unclear why professional societies and medical boards have been so silent about guidelines with a weak evidence base. Both were created to protect the public's health. Practice of medicine and nursing has been restricted to those with appropriate education and licensure who accept the responsibility for their actions. The guideline process can allow the unscrupulous to side step these regulations and responsibility, sometimes for their own financial gain. If the medical societies and medical boards are unwilling to intervene, perhaps a federal agency or regulator not vulnerable to such concerns might be better suited to regulate the implementation of guidelines.

Richard A. Robbins, MD*

Editor

References

1. Feuerstein JD, Akbari M, Gifford AE, Hurley CM, Leffler DA, Sheth SG, Cheifetz AS. Systematic analysis underlying the quality of the scientific evidence and conflicts of interest in interventional medicine subspecialty guidelines. Mayo Clin Proc. 2014;89(1):16-24. [CrossRef] [PubMed] 
2. Mathew M. January 2014 pulmonary journal club: interventional guidelines. Southwest J Pulm Crit Care. 2014;8(1):70. [CrossRef]
3. Lee DH, Vielemeyer O. Analysis of overall level of evidence behind infectious diseases society of America practice guidelines. Arch Intern Med. 2011;171:18-22. [CrossRef] [PubMed] 
4. NICE-SUGAR Study Investigators, Finfer S, Chittock DR, et al. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360(13):1283-97. [CrossRef] [PubMed] 
5. Ranieri VM, Thompson BT, Barie PS, et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 2012; 366:2055-64. [CrossRef] [PubMed] 
6. Maitland K, Kiguli S, Opoka RO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011;364(26):2483-95. [CrossRef] [PubMed] 
7. Eichacker PQ, Natanson C, Danner RL. Surviving Sepsis – Practice guidelines, marketing campaigns and Eli Lilly. N Engl J Med 2006;355:1640-2. [CrossRef] [PubMed]
8. Raschke RA. July 2012 critical care journal club. Southwest J Pulm Crit Care 2012;5:54-7.
9. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]

*The views expressed in this editorial are those of the author and do not necessarily represent the views of the Arizona, New Mexico, Colorado or California Thoracic Societies or the Mayo Clinic.

Reference as: Robbins RA. What's wrong with expert opinion? Southwest J Pulm Crit Care. 2014;8(1):71-3. doi: http://dx.doi.org/10.13175/swjpcc008-14 PDF