Gottlieb, the FDA and Dumbing Down Medicine

Gottlieb, the FDA and Dumbing Down Medicine

In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7.  However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1). Others praised Gottlieb as the right man to lead the FDA.

As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2). Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight answer when asked to share his thoughts on drug importation. While President Donald Trump has supported increased drug importation and is reported to be working with Democratic lawmakers on drug importation legislation, Dr. Gottlieb had previously opposed the measure (1). When asked if he opposes importing cheaper drugs from foreign countries, he said, "I can tell you I have a lot of ideas that I want to work on right away on how I think we can get more product competition onto the market."

Gottlieb stated that the FDA could speed up approval of new drugs and devices (1). However, a letter to the editor published in the New England Journal of Medicine examined compared review times for new therapeutic agents that were approved by the FDA or the European Medicines Agency (EMA), the primary drug regulator in Europe, between 2011 and 2015 (3). The median total review time was 306 days (interquartile range, 239 to 371) at the FDA, as compared with 383 days (interquartile range, 327 to 446) at the EMA.

In welcome news to many physicians, Gottlieb voiced uneasiness over increasing regulation of physicians’ practices (1). “My concern that the agency was losing confidence in physicians and felt it need[ed] …to supplant their judgment for the judgment of doctors,” Gottlieb said. He had previously referred to the FDA’s action on Arcoxia, a pain killer that was rejected in April 2007 because of concern that it could increase the risk of heart attack and stroke with prolonged use despite being meant for short-term pain relief. Gottlieb stated the opioid epidemic would be his "highest and most immediate priority." He added that the epidemic is a "public health emergency on the order of Ebola and Zika" that requires dramatic action from the FDA. "[T]o address it now, the types of actions that we are going to need to take are going to be more dramatic, perhaps, than the types of actions we would have taken 10 years ago."

Gottlieb did not note that some have linked the present opioid crisis to meddling by bureaucrats, administrations and politicians as an unattended consequence of the pain scale, opioid prescribing guidelines and patient satisfaction ratings (4). Furthermore, he did not note that increasing prescribing authority has been given to non-physicians with less education and clinical experience, e.g., unsupervised nurse practitioners in the Department of Veterans Affairs (5). Whether these non-physician clinicians will use drugs any more or less appropriately than physicians is unclear.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Dickson V. Gottlieb favors regulations that empower doctors while keeping FDA standards. Modern Healthcare. April 5, 2017. Available at: http://www.modernhealthcare.com/article/20170405/NEWS/170409965 (requires subscription, accessed 4/11/17).
2. Dodgson L. Trump has suggested vaccines cause autism — an idea that couldn't be more wrong. Business Insider. January 24, 2017. Available at: http://www.businessinsider.com/trump-vaccines-autism-wrong-2017-1 (accessed 4/11/17).
3. Downing NS, Zhang AD, Ross JS. Regulatory review of new therapeutic agents — FDA versus EMA, 2011–2015. N Engl J Med. 2017Apr 6;376:1386-7. [CrossRef] [PubMed]
4. Robbins RA. Pain scales and the opioid crisis. Southwest J Pulm Crit Care. 2017;14(3):119-22. [CrossRef]
5. Department of Veterans Affairs. VA grants full practice authority to advance practice registered nurses. December 14, 2016. Available at: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2847 (accessed 4/11/17).

Cite as: Robbins RA. Gottlieb, the FDA and dumbing down medicine. Southwest J Pulm Crit Care. 2017;14(4):166-7. doi: https://doi.org/10.13175/swjpcc047-17 PDF 

Salary Surveys Report Declines in Pulmonologist, Allergist and Nurse Incomes

The 2016 Medscape Physician Compensation Report relates that orthopedic surgeons and cardiologists earn on average the most of those physicians surveyed ($443,000 and $410,000 annually) (1). Pulmonologists and critical care physicians fell in the middle of the spectrum of physician incomes ($281,000 and $306,000 respectively). Allergists were at the lower end ($205,000). Physicians in each category earned more or the same in 2016 than in 2015 except pulmonologists and allergists which were down compared to 2015 incomes of $296,000 ($15,000 decline) and $243,000 ($38,000 decline). As in years past, the survey is nonscientific. Physicians were asked to provide their annual compensation for patient care including salary, bonus, and profit sharing if employed, earnings after taxes, and deductible business expenses (but before income tax) if in private practice. 

The reason for the decrease is unclear but self-employed physicians (i.e., private practice) earned substantially more than employed physicians ($64,000 more for men, $44,000 more for women) (1). If more pulmonary physicians are becoming employed, this could be one reason for the decline in income. In 2016, the Medscape survey reported 59% of men and 72% of women were employed (1).

Nurses also made less on average in 2016. Incomes decreased from $79,000 annually for RNs in 2015 to $78,000 in 2016 (2). LPNs had a more substantial decrease from $46,000 to $43,000. RN’s not employed full time made the same hourly wage as those employed full time ($37/hour) and LPNs not employed full time actually made more per hour than those employed full time ($23 compared to $21/hour). The two most common reasons that nurses gave for decreased income was switching jobs or working less overtime.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Peckham C.  Medscape Physician Compensation Report 2016. Medscape. April 1, 2016. Available at: http://www.medscape.com/features/slideshow/compensation/2016/public/overview#page=1 (accessed 2/9/17).
2. Yox SB, Stokowski LA, McBride M, Berry E.  Medscape RN/LPN Salary Report 2016. Medscape. November 2, 2016. Available at: http://www.medscape.com/features/slideshow/nurse-salary-report-2016?src=WNL_specrep_nursesalary_170209_MSCPEDIT_usmds&uac=9273DT&impID=1286926&faf=1#page=1 (accessed 2/9/17).

Cite as: Robbins RA. Salary surveys report declines in pulmonologist, allergist and nurse incomes. Southwest J Pulm Crit Care. 2017;14(2):68. doi: https://doi.org/10.13175/swjpcc018-17 PDF 

CDC Releases Ventilator-Associated Events Criteria

A new term has been coined by the CDC, ventilator-associated events (VAEs) (1). In 2011, the CDC convened a working group composed of members of several stakeholder organizations to address the limitations of the definition of ventilator-associated pneumonia (VAP) definition (2). The organizations represented in the Working Group include: the Critical Care Societies Collaborative (the American Association of Critical-Care Nurses, the American College of Chest Physicians, the American Thoracic Society, and the Society for Critical Care Medicine); the American Association for Respiratory Care; the Association of Professionals in Infection Control and Epidemiology; the Council of State and Territorial Epidemiologists; the Healthcare Infection Control Practices Advisory Committee’s Surveillance Working Group; the Infectious Diseases Society of America; and the Society for Healthcare Epidemiology of America.

VAEs are defined by an increase oxygen (>0.2 in FiO2) or positive end-expiratory pressure (PEEP) (≥3 cm H2O), after a previous stable baseline of at least 2 days. There are three definition tiers within the VAE algorithm: 1) Ventilator-Associated Condition (VAC); 2) Infection-related Ventilator-Associated Complication (IVAC); and 3) Possible VAP (PVAP) (2). There are also many other criteria to classify a VAE into the CDC’s tiers which are omitted for brevity. These definitions have been implemented in the National Healthcare Safety Network (NHSN) and according to the CDC are easily implemented, can make use of electronic health record systems to automate event detection, and identify events that are clinically important and associated with outcomes such as ICU and hospital length of stay and mortality. According to the CDC most VACs are due to pneumonia, ARDS, atelectasis, and pulmonary edema which “are significant clinical conditions that may be preventable”.

The CDC says "the VAE definition algorithm is for use in surveillance; it is not a clinical definition algorithm and is not intended for use in the clinical management of patients”. Based on the experience with the hospital acquired infections program this seems unlikely. What seems more likely is that hospitals will be measured on VAE rates with financial or public relations consequences shortly to follow.

The best evidence suggests that the VAE concept is not useful for guiding clinical decisions in the moment (1). Its performance characteristics as a screening test appear to be terrible, with poor sensitivity (~32%) for detecting VAP in the one of the only prospective studies. This is because clinically insignificant fluctuations in oxygenation/PEEP status are often recorded as VAEs, diluting signal with noise. Numerous retrospective reviews supporting the VAE concept listed on CDC's website strongly link VAEs with morbidity and mortality. However, these observations could be true of many events and may be very different from showing that a prospective (intervention-based) approach is helpful. Pulmonologist Dr. Richard Wunderink from Northwestern commented that “the central hypothesis of the VAE criteria—that VAP and other potentially preventable complications of mechanical ventilation can consistently be detected by worsening gas exchange—is clearly not true”.

The problems with VAE appear much the same as the problems with VAP. Neither is strongly evidence-based and neither has been shown to be helpful in patient care. Furthermore, it might be possible to “game” the numbers by adjusting PEEP, expiratory time, and FiO2 within the defined limits.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Pulm/CCM. What are ventilator-associated events (and why should you care)? Available at: http://pulmccm.org/main/2014/review-articles/ventilator-associated-events-care/?utm_source=Email+Updates+from+PulmCCM&utm_campaign=b1ee59472e-USP_mar_24_2014&utm_medium=email&utm_term=0_e9d9e09c7c-b1ee59472e-312029025 (accessed 1/24/17).
2. CDC. Ventilator-associated event (VAE). January 2017. Available at: https://www.cdc.gov/nhsn/pdfs/pscManual/10-VAE_FINAL.pdf (accessed 1/24/17).

Cite as: Robbins RA. CDC releases ventilator-associated events criteria. Southwest J Pulm Crit Care. 2017:14(1):40-1. doi: https://doi.org/10.13175/swjpcc009-17 PDF 

Medicare Bundled Payment Initiative Did Not Reduce COPD Readmissions

Implementation of the Medicare bundled payments for care improvement initiative has failed to cut readmission rates following hospitalization for acute exacerbation of chronic obstructive pulmonary disease (COPD), according to a study published in the Annals of the American Thoracic Society (1).

Bhatt and colleagues (1) from the University of Alabama at Birmingham enrolled 78 consecutive Medicare patients in 2014 compared to 109 patients in the historic group from 2012. They found that patients from 2014 were more likely to have compliance with the bundled care payment requirements. However, there was no difference in all-cause readmission rates at 30 days (15.4% vs.17.4%; p=.711), and 90 days (26.9% vs 33.9%; p=.306).

The bundled care requirements include regular follow-up phone calls, pneumococcal and influenza vaccines, home health care, durable medical equipment, pulmonary rehabilitation, and to attend pulmonary clinic which were significantly increased after implementation of the bundled care requirements. However, these COPD interventions were implemented despite having not been shown to decrease COPD readmissions (2). Furthermore, Shah et al. (3) have reported that only 27.6% of COPD hospital readmissions are for COPD making these COPD interventions even less likely to reduce readmissions.

References

1. Bhatt SP, Wells JM, Iyer AS, et al. Results of a Medicare Bundled Payments for Care Improvement Initiative for COPD Readmissions. Ann Am Thorac Soc. 2016 Dec 22 [Epub ahead of print]. [CrossRef] [PubMed]
2. Robbins RA, Wesselius LJ. Reducing readmissions after a COPD exacerbation: a brief review. Southwest J Pulm Crit Care. 2015;11(1):19-24. [CrossRef]
3. Shah T, Churpek MM, Coca Perraillon M, Konetzka RT. Understanding why patients with COPD get readmitted: a large national study to delineate the medicare population for the readmissions penalty expansion. Chest. 2015;147(5):1219-26. [CrossRef] [PubMed]

Cite as: Robbins RA. Medicare bundled payment initiative did not reduce COPD readmissions. Southwest J Pulm Crit Care. 2016;14(1):26. doi: https://doi.org/10.13175/swjpcc104-17 PDF

Younger Smokers Continue to Smoke as Adults: Implications for Raising the Smoking Age to 21

A review article published in Pediatrics assesses the evidence that smoking is particularly harmful the younger a smoker begins (1). Not only do youths tend to accumulate more pack-years but they have more difficulty quitting. The recent shift in smoking trends from tobacco cigarettes to e-cigarettes may not be helpful since both contain the addictive component, nicotine. Although e-cigarettes are marketed as a smoking cessation tool, there is no strong evidence to support these claims, the authors report.

"I think most people realize nicotine is addictive, but I don't know if there's an understanding of just how addictive it is – particularly for youths," said Lorena M. Siqueira, MD, MSPH, lead author of the report (2).

Evidence shows that the earlier in life a person is exposed to nicotine, the more likely they will consume greater quantities and the less likely they will be able to quit (1,2). The vast majority of tobacco-dependent adults (>99%) started smoking before age 26 years. Approximately two thirds of children who smoke in sixth grade, become regular smokers as adults. In comparison, 46% of youth who begin smoking in the eleventh grade go on to become regular smokers as adults. Youths require more attempts to quit smoking before being successful compared to adults. Only about 4% of smokers aged 12 to 19 years have been shown to successfully quit each year.

"There are now seven published longitudinal studies showing that youths who initiate smoking with e-cigarettes are about three times more likely to be smoking conventional cigarettes a year later," said Stanton A. Glantz, PhD, of the Center for Tobacco Research and Education at the University of California and a coauthor of the review (2). Instead of making quitting easier, e-cigarettes make it harder, Dr. Glantz added.

An Institute of Medicine report notes that the age of initiation of smoking is critical (3). The report estimates that that raising the minimum age for the sale of tobacco products to 21 will, over time, reduce the smoking rate by about 12 percent. This reduction is estimated to result in reducing smoking-related deaths by 10 percent, which translates into 223,000 fewer premature deaths, 50,000 fewer deaths from lung cancer, and 4.2 million fewer years of life lost (3).

These data may prove valuable in evaluating the potential health impact of this legislation.  California became the second state to raise the tobacco sale age to 21 in 2016, joining Hawaii (3). At least 210 localities have raised the tobacco age to 21, including New York City, Chicago, Boston, Cleveland, Kansas City and Cottonwood, Arizona. Statewide legislation to do so is being considered in several other states and will probably be introduced in Arizona during this legislative session.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Siqueira LM; Committee on Substance Use and Prevention. Nicotine and tobacco as substances of abuse in children and adolescents. Pediatrics. 2017 Jan;139(1):e20163436. [CrossRef] [PubMed]
2. Melville NA. Nicotine's highly addictive impact on youth underestimated. Medscape. January 3, 2017. Available at: http://www.medscape.com/viewarticle/873955?nlid=111769_2863&src=wnl_dne_170104_mscpedit&uac=9273DT&impID=1266832&faf=1 (accessed 1/5/17).
3. Campaign for Tobacco Free Kids. Increasing the minimum legal sale age for tobacco products to 21. Available at: https://www.tobaccofreekids.org/research/factsheets/pdf/0376.pdf (accessed 1/5/17).

Cite as: Robbins RA. Younger smokers continue to smoke as adults: implications for raising the smoking age to 21. Southwest J Pulm Crit Care. 2017;14(1):24-5. doi: https://doi.org/10.13175/swjpcc002-17 PDF