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 

Pain Scales and the Opioid Crisis

In the last year, physicians and nurses have increasingly voiced their dissatisfaction with pain as the fifth vital sign. In June 2016, the American Medical Association recommended that pain scales be removed in professional medical standards (1). In September 2016, the American Academy of Family Physicians did the same (2). A recent Medscape survey reported that over half of surveyed doctors and nurses supported removal of pain assessment as a routine vital sign (3).

In the 1990’s there was a widespread impression that pain was undertreated. Whether this was true or an impression created by a few practitioners and undertreated patients with the support of the pharmaceutical industry is unclear. Nevertheless, the prevailing thought became that identifying and quantifying pain would lead to more appropriate pain therapy. The American Society of Anesthesiologists and the American Pain Society issued practice guidelines for pain management (4,5). Subsequently, both the Department of Veterans Affairs and the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) mandated a pain scale as the fifth vital sign (6-9). Most commonly these scales ask patients to rate their pain on a scale of 1-10. The JCAHO mandated that "Pain is assessed in all patients” and would give hospitals "requirements for Improvement" if they failed to meet this standard (9). The JCAHO also published a book in 2000 for purchase as part of required continuing education seminars (9). The book cited studies that claimed "there is no evidence that addiction is a significant issue when persons are given opioids for pain control." It also called doctors' concerns about addiction side effects "inaccurate and exaggerated." The book was sponsored by Purdue Pharma makers of oxycodone.

Almost as soon as the standards were initiated, suggestions emerged that pain treatment was becoming overzealous. In 2003 a survey of 250 adults who had undergone surgical procedures reported that almost 90% were satisfied with their pain medications. Nevertheless, the authors concluded that “many patients continue to experience intense pain after surgery … additional efforts are required to improve patients’ postoperative pain experience” (8). Concerns about overaggressive treatment for pain increased after Vila et al. (10) reported in 2005 that the incidence of opioid oversedation increased from 11.0 to 24.5 per 100 000 inpatient hospital days after the hospitals implemented a numerical pain treatment algorithm. As early as 2002 the Institute for Safe Medication Practices linked overaggressive pain management to a substantial increase in oversedation and fatal respiratory depression events (11). Articles appeared questioning the wisdom of asking every patient to rate their pain noting that implementation of the scale did not appear to improve pain management (12). The JCAHO removed its standard to assess pain in all patients but not until 2009.

The US has seen a dramatic increase in the incidence of opioid deaths (13). It is unclear if adoption of the pain scale and its widespread application to all patients contributed to the increase although the time frame and the data from Vila et al. (10) suggest that this is likely.

There have been other factors that may have also contributed to the increase in opioid deaths. The Medscape survey mentioned above asked participants how often they feel pressure to prescribe pain medication in order to keep patient satisfaction levels high (3). Specifically mentioned was the Hospital Consumer Assessment of Healthcare Providers and Systems or HCAHPS. HCAHPS is a patient satisfaction survey required for all hospitals in the US. About two thirds of doctors and nurses felt there was pressure (3). The survey also asked respondents about the influence of patient reviews on opioid prescribing. Forty-six percent of doctors said the reviews were more than slightly influential. The surveys seemed to carry more weight with nurses. Seventy-three percent said the reviews were influential. Others have blamed pharmaceutical company marketing opioids as a way of reducing pain and increasing patient satisfaction (14). Clearly, there has been a dramatic increase in narcotic prescriptions. Not surprisingly, pharmaceutical companies have done little to curb the use of their products.

Earlier this year, former CDC Director Tom Frieden said "The prescription overdose epidemic is doctor-driven…It can be reversed in part by doctors' actions” (15). Some physicians have taken this as blame for the entire opioid crisis, including deaths from heroin and illegal fentanyl. There may be some validity in this belief since abuse of illegal narcotics sometimes evolves out of abuse of prescribed narcotics. However, the actions of the health regulatory agencies that mandated pain scales and created guidelines for pain management were not mentioned by Dr. Frieden. Also, not mentioned are the patient satisfaction surveys. 

About a year ago the CDC issued guidelines for prescribing opioids for chronic pain (15). These guidelines were developed in collaboration with a number of federal agencies including the Department of Veterans Affairs which was one of the first to mandate pain scales and the Centers for Medicare and Medicaid Services (CMS) which mandated HCAHPS. Pain is a subjective symptom and quantification and treatment are imprecise. The goal cannot be to deliver perfect pain management but to reduce the incidence of under- and overtreatment as much as possible. Someone needs to assess patients’ pain complaints and prescribe opioids appropriately. No one is better qualified and prepared than the clinician at the bedside.

No one condones the unethical practice of widespread prescription of opioids without sufficient medical oversight. However, meddling by unqualified bureaucrats, administrators and politicians emphasizes guidelines over appropriate care. As detailed above, the present opioid crisis may be an unattended consequence of the pain scale and opioid prescribing guidelines. Further intrusion by the same groups who created the crisis is unlikely to solve the problem but is likely to create additional problems such as the undertreatment of patients with severe pain. As I write this on the ides of March it may be appropriate to paraphrase a line from Julius Cesar, “The fault lies not in our doctors but in our regulators”.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Anson P. AMA drops pain as vital sign. Pain News Network. June 16, 2016. Available at: https://www.painnewsnetwork.org/stories/2016/6/16/ama-drops-pain-as-vital-sign (accessed 3/2/17).
2. Lowes R. Drop pain as the fifth vital sign, AAFP says. Medscape Medical News. September 22, 2016. Available at: http://www.medscape.com/viewarticle/869169 (accessed 3/2/17).
3. Ault A. Many physicians, nurses want pain removed as fifth vital sign. Medscape Medical News. Medscape Medical News. February 21, 2017. Available at: http://www.medscape.com/viewarticle/875980?nlid=113119_3464&src=WNL_mdplsfeat_170228_mscpedit_ccmd&uac=9273DT&spon=32&impID=1299168&faf=1 (accessed 3/2/17).
4. Practice guidelines for acute pain management in the perioperative setting. A report by the American Society of Anesthesiologists Task Force on Pain Management, Acute Pain Section. Anesthesiology. 1995 Apr;82(4):1071-81. [CrossRef] [PubMed]
5. Gordon DB, Dahl JL, Miaskowski C, McCarberg B, Todd KH, Paice JA, Lipman AG, Bookbinder M, Sanders SH, Turk DC, Carr DB. American pain society recommendations for improving the quality of acute and cancer pain management: American Pain Society Quality of Care Task Force. Arch Intern Med. 2005 Jul 25;165(14):1574-80. [CrossRef] [PubMed]
6. National Pain Management Coordinating Committee. Pain as the 5Th vital sign toolkit. Department of Veterans Affairs. October 2000. Available at: https://www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf (accessed 3/2/17).
7. Baker DW. History of The Joint Commission's Pain Standards: Lessons for Today's Prescription Opioid Epidemic. JAMA. 2017 Mar 21;317(11):1117-8. [CrossRef] [PubMed]
8. Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97(2):534-540. [CrossRef] [PubMed]
9. Moghe S. Opioid history: From 'wonder drug' to abuse epidemic. CNN. October 14, 2016. Available at: http://www.cnn.com/2016/05/12/health/opioid-addiction-history/ (accessed 3/2/17).
10. Vila H Jr, Smith RA, Augustyniak MJ, et al. The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: is patient safety compromised by treatment based solely on numerical pain ratings? Anesth Analg. 2005;101(2):474-480. [CrossRef] [PubMed]
11. Institute for Safe Medication Practices. Pain scales don’t weigh every risk. July 24, 2002. Available at: https://www.ismp.org/newsletters/acutecare/articles/20020724.asp (accessed 3/2/17).
12. Mularski RA, White-Chu F, Overbay D, Miller L, Asch SM, Ganzini L. Measuring pain as the 5th vital sign does not improve quality of pain management. J Gen Intern Med. 2006 Jun;21(6):607-12. [CrossRef] [PubMed] 
13. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 16;65. Published on-line. [CrossRef] [PubMed]
14. Cha AE. The drug industry’s answer to opioid addiction: More pills. Washington Post. October 16, 2016. Available at: https://www.washingtonpost.com/national/the-drug-industrys-answer-to-opioid-addiction-more-pills/2016/10/15/181a529c-8ae4-11e6-bff0-d53f592f176e_story.html?utm_term=.36c5992fa62f (accessed 3/2/17).
15. Lowes R. CDC issues opioid guidelines for 'doctor-driven' epidemic. Medscape. March 15, 2016. Available at: http://www.medscape.com/viewarticle/860452 (accessed 3/2/17).

Cite as: Robbins RA. Pain scales and the opioid crisis. Southwest J Pulm Crit Care. 2017;14(3):119-22. doi: https://doi.org/10.13175/swjpcc033-17 PDF