Practice Fusion Admits to Opioid Kickback Scheme

Practice Fusion, a San Francisco-based health information technology developer, will pay $145 million to resolve criminal and civil investigations relating to its electronic health records (EHR) software (1). The Department of Justice announced on January 27th that the company admitted it solicited and received kickbacks from a major opioid company in exchange for utilizing its software to influence physicians prescribing opioid pain medications. The pharmaceutical company is widely speculated to be Purdue Pharma which faces U.S. Justice Department probes and sprawling litigation over allegations it played a central role in the deadly opioid crisis (2).

The DOJ said Practice Fusion extracted kickbacks from pharmaceutical companies in exchange for implementing a clinical decision support (CDS) system in its electronic health records (EHR) software designed to increase prescriptions for their drug products. In exchange for “sponsorship” payments from pharmaceutical companies, Practice Fusion allowed the companies to craft CDS alerts to increase sales of the companies’ products, resulting in alerts that did not always reflect accepted medical standards. In their criminal probe of opioid makers, federal prosecutors have indicted pharmaceutical company executives, physicians and pharmacists. This is the first criminal action against an EHR vendor and no indictments of any Practice Fusion executives were made.

Founded in 2005, Practice Fusion offers an EHR tailored for smaller, independent physician practices. It supports practices that comprise 112,000 health care workers who see 5 million patient visits per month. Practice Fusion had expected to go public at a valuation of about $1.5 billion, but was instead acquired in 2018 by Chicago-based Allscripts for $100 million in cash.

Our practice at Arizona Chest and Sleep Medicine uses Practice Fusion in its outpatient clinics. None of us were aware of receiving any alerts advising prescribing opioids.

References

1. Johnson T. S.F.-based Practice Fusion Inc. admits to opioid kickback scheme. San Francisco Business Times. January 28, 2020. Available at: https://www.bizjournals.com/sanfrancisco/news/2020/01/28/s-f-based-practice-fusion-inc-admits-to-opioid.html (accessed 2/3/20).
2. Spector M, Hals T. OxyContin maker Purdue is 'Pharma Co X' in U.S. opioid kickback probe – sources. Reuters. January 28, 2020. Available at: https://www.reuters.com/article/us-purdue-pharma-investigation-opioids-e/exclusive-oxycontin-maker-purdue-is-pharma-co-x-in-us-opioid-kickback-probe-sources-idUSKBN1ZR2RY (accessed 2/3/20).

Cite as: Robbins RA. Practice Fusion admits to opioid kickback scheme. Southwest J Pulm Crit Care. 2020;20(2):63. doi: https://doi.org/10.13175/swjpcc010-20 PDF

Arizona Averages Over 25 Opioid Overdoses Per Day

An Arizona Republic article and the Arizona Department of Health Services Director's blog, Dr. Cara Christ, brings the opioid crisis home (1,2). Christ states that over 3200 opioid overdoses with over 400 deaths occurred between June 15 and October 17 in Arizona. This averages to over 25 overdoses and 3 deaths per day.

Some of the data from Christ’s blog are below:

• Males 25-29 have the highest rates of suspected opioid overdoses.
• 37% of people experiencing a suspected opioid overdose had an opioid prescription in the two months prior to their overdose.
• The majority of overdoses occur at home.
• The most commonly cited pre-existing health conditions of those with suspected overdoses was chronic pain. Depression and other behavioral health conditions were also common health conditions noted.
• Meth and heroin were the most frequently cited drugs involved in reported neonatal abstinence syndrome.
• About 40% of people experiencing suspected opioid overdoses who had a prescription in the Controlled Substances Prescription Monitoring Program had been prescribed both benzodiazepines and opioids in 2017. When these medications are combined, it is so dangerous that the FDA gives it a “black box” warning.
• About 40% of people experiencing a suspected overdose that had prescription history in the Controlled Substances Prescription Monitoring Program (CSPMP) had received opioid prescriptions from 10 or more providers.
• Only about 25% of clinicians prescribing controlled substances checked the CSPMP prior to prescribing.

On October 16, a new mandate went into effect that requires clinicians to check the CSPMP prior to prescribing an opioid or benzodiazepine. Other states implementing such mandates have experienced reductions in people with 4 or more prescribers or pharmacies, reductions in opioid prescribing, and reductions in Morphine Milligram Equivalent daily doses.

The CSPMP requires registration and login but is relatively easy to use (3). You can search not only in Arizona but other states as well. Personally, as a pulmonary consultant I infrequently prescribe opioids or benzodiazepines. However, I have used the website once to check a benzodiazepam prescription for a patient I suspect might be addicted. No other prescriptions were found. It at least gave me some assurance that he was not obtaining prescriptions from multiple practioners while we attempt to wean him off this medication.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. McCrory C. More than 400 opioid-overdose deaths reported in Arizona since June 15. Arizona Republic. October 27, 2017. Available at: http://www.azcentral.com/story/news/local/arizona/2017/10/27/more-than-400-opioid-overdose-deaths-reported-arizona-since-june-15/809157001/ (accessed 10/28/17).
2. Christ CM. Opioid update: latest data and emergency rules update. October 17, 2017. Available at: http://directorsblog.health.azdhs.gov/opioid-update-latest-data-and-emergency-rules-update/ (accessed 10/28/17).
3. Arizona Board of Pharmacy. Arizona PMP Aware. Available at: https://pharmacypmp.az.gov/ (accessed 10/28/17).

Cite as: Robbins RA. Arizona averages over 25 opioid overdoses per day. Southwest J Pulm Crit Care. 2017;15(4):179-80. doi: https://doi.org/10.13175/swjpcc133-17 PDF 

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 

Most Drug Overdose Deaths from Nonprescription Opioids

The Centers for Disease Control (CDC) is reporting in Morbidity and Mortality Weekly that the number of people dying from an opioid overdose rose 15.5% from 2014 to 2015, but the increase had little to do with prescription painkillers such as oxycodone or hydrocodone (1). Roughly 52,000 people died from drug overdoses in 2015 and of those deaths 33,091 involved an opioid. The increases in “death rates were driven by synthetic opioids other than methadone (72.2%), most likely illicitly-manufactured fentanyl, and heroin (20.6%)”. Deaths from methadone, which is usually prescribed by physicians, decreased 9.1%.

The largest increase in deaths occurred in the South and Northeast with 3% and 24% increases in deaths from synthetic opioids from 2014 to 2015. In the Midwest and West, there were more modest 17% and 9% increases during the same period. States in the Southwest with “good” to “excellent” reporting included Colorado, Nevada, and New Mexico which showed 33%, 14% and 30% decreases respectively.

Earlier this year, CDC Director Tom Frieden, MD, MPH, said "The prescription overdose epidemic is doctor-driven…It can be reversed in part by doctors' actions” (2). That characterization has rung in some physicians' ears as blame for the entire opioid crisis, including deaths from heroin and illegal fentanyl. The data in the present article suggests that characterization is inaccurate and that efforts by a number of State Boards to limit physician opioid prescribing may be marginally or non-effective in reducing overdose deaths.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. 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]
2. Lowes R. CDC issues opioid guidelines for 'doctor-driven' epidemic. Medscape. March 15, 2016. Available at: http://www.medscape.com/viewarticle/860452 (accessed 12/21/16).

Cite as: Robbins RA. Most drug overdose deaths from nonprescription opioids. Southwest J Pulm Crit Care. 2016;13(6):316. doi: https://doi.org/10.13175/swjpcc145-16 PDF

Top Medical News Stories 2015

Here is our list of the top seven medical news stories for 2015 with special emphasis on the Southwest.

7. Wearable health devices

A wave of wearable computing devices such as Fitbit and UP wristbands have people keeping track of how much they sit, stand, walk, climb stairs and calories they consume (1). These fitness-tracking devices herald a series of devices that will detect and monitor serious diseases. However, these so-called medical-grade wearables require approval from the U.S. Food and Drug Administration, a regulatory hurdle avoided by the fitness-tracking devices which will likely slow their introduction.

6. Caitlyn Jenner

Caitlyn Jenner became the most famous transgender woman in the world following an interview published in Vanity Fair (2). The Vanity Fair website saw 11.6 million visits curious about the former Olympic athlete. Though Jenner publicly shared her gender identity, many transgender Americans do not-12% of gender non-conforming adults said they had never told anyone about their gender identity. Jenner's "coming out" has and will likely continue to draw increasing attention to gender dysphoria. In Arizona, the Tucson VA recently established a transgender clinic (3).

5. Ebola

Two years after the beginning of an Ebola outbreak in West Africa, the virus continues to strike fear in the US. The Ebola outbreak sickened more than 28,630 people and killed at least 11,300, according to the World Health Organization (4). While the epidemic subsided in 2015, the virus has never completely gone away. The only Ebola cases today are in Liberia, a nation twice declared "Ebola free" suggesting that eliminating Ebola may be difficult.

4. Terrorism in San Bernardino

Multiple terror attacks have occurred in far off places like Afghanistan and Paris, but terror was brought to the Southwest in 2015 by 2 terrorists who killed 14 at a holiday party earlier in December in San Bernardino, California (5). The attack generated concern about emergency preparedness and will likely generate training for triaging and care of multiple gunshot victims.

3. Vaccines

A measles outbreak that started at Disneyland spread to 117 people earlier this year and changed the national conversation about vaccinations (1). The outbreak also drew attention to Disneyland's Orange County where a relatively large percentage of the population is not vaccinated. The outbreak spurred California and Vermont to strengthen their school vaccine laws. Vermont repealed its "personal belief" exemption, which allowed unvaccinated children to attend school if their parents objected to vaccines for philosophical reasons. California went even further, putting an end to both personal belief and religious exemptions.

2. Opioids

Deaths from opioid drug overdoses have hit an all-time record in the U.S., rising 14 percent in just one year (6). More than 47,000 people died from these drug overdoses last year according to the CDC. Concomitant with the introduction of the pain scale as the "fifth" vital sign and continued criticism of doctors for undertreating pain, prescription opioid sales have quadrupled in the US since 1999. The CDC announced that it will issue guidelines to reduce opioid overdoses and prescribing.

1. Prescription Drug Prices

Concern over high drug costs has been building for years. Prices for cancer drugs often exceed $100,000 a year and Gilead priced its breakthrough hepatitis C drug at $84,000 for a 12-week treatment (4). Outrage over drug prices boiled over in 2015 when Turing Pharmaceuticals purchased the rights to pyrimethamine and immediately hiked the price from $13.50 a pill to $750 a pill. Pyrimethamine (Daraprim®) is a medication used for protozoal infections such as Toxoplasma gondii, an infection usually seen in AIDS patients. An October poll from the Kaiser Family Foundation found that 77% of those surveyed said that drug prices should be a top priority for Congress and the White House should and 63% favored government action to lower prescription drug prices.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Reddy S. Year in review: top 10 health issues of 2015. Wall Street Journal. December, 29, 2015. Available at: http://www.wsj.com/articles/year-in-review-top-10-health-issues-of-2015-1451341107 (accessed 12/31/15).
2. Chalabi M. 2015: the top news stories of the year in numbers. The Guardian. December 28, 2015. Available at: http://www.theguardian.com/news/datablog/2015/dec/28/2015-news-stories-of-the-year-in-numbers-police-shootings-syria-gay-marriage-star-wars (accessed 12/31/15).
3. Transgender services. Available at: http://www.tucson.va.gov/services/Transgender_Services.asp (accessed 12/31/15).
4. Szabo L. That $750 pill and more: 2015's top health stories. USA Today. December 15, 2015. Available at: http://www.usatoday.com/story/news/2015/12/15/five-medical-stories-led-news-2015/77296624/ (accessed 12/31/15).
5. Domonoske C. San Bernardino shootings: what we know, one day after. NPR. December 3, 2015. Available at: http://www.npr.org/sections/thetwo-way/2015/12/03/458277103/san-bernardino-shootings-what-we-know-one-day-after (accessed 12/31/15).
6. Siegel R. Draft of CDC's new prescribing guidelines stirs debate. NPR. December 29, 2015. Available at: http://www.npr.org/2015/12/29/461409296/draft-of-cdcs-new-prescribing-guidelines-stirs-debate (accessed 12/31/15).

Cite as: Robbins RA. Top medical news stories 2015. Southwest J Pulm Crit Care. 2015;11(6):285-6. doi: http://dx.doi.org/10.13175/swjpcc159-15 PDF