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Johnson v. Monsanto: Roundup and product liability
QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.
Which of the following statements is incorrect?
A. These are all examples of product liability.
B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.
C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.
D. It is now harder to include multiple plaintiffs in a class-action lawsuit.
E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.
ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.1 DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.
The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”2 Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.
At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.
Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.
The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.
Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”
There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.
In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.3 He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.
The California Supreme Court went beyond the law of contracts and negligence by introducing the notion of strict liability, which centers on whether a product is defective and unreasonably dangerous. It holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs.
“Defective” is usually defined as product quality that is less than what a reasonable consumer expects. It can be a design, manufacturing, or marketing defect, the latter instance typically showing up as a failure to warn. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.
Product liability lawsuits commonly involve pharmaceutical products and medical devices. Recent examples are suits against Pfizer over Lipitor’s alleged role as a cause of diabetes and against Johnson & Johnson over its talcum products purportedly causing ovarian cancer.4
When the same product injures multiple plaintiffs, they may band together to file a common legal action against the manufacturer. This is called a class-action suit, and will proceed if it is certified to satisfy four prerequisites: numerosity, commonality, typicality, and adequacy.5 A class-action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.
A recent U.S. Supreme Court decision has, however, put a damper on class-action suits by tightening the jurisdictional requirement.6
The case involved Bristol-Myers Squibb, which was sued in California by several hundred individuals from 33 states for injuries from the platelet inhibitor Plavix (clopidogrel). The issue was whether non–California residents could sue in that state for injuries incurred elsewhere.
In a 8-1 decision, the U.S. Supreme Court held that California courts did not have specific jurisdiction to hear the claims of nonresidents without identifying an adequate link between the state and the nonresidents’ claims, as they weren’t prescribed Plavix in the state, didn’t buy or take the drug there, and weren’t injured by the drug there.
Finally, note that, should a doctor fail to warn an injured patient of a known medication risk, the patient may have a claim against the doctor – but usually not against the drug manufacturer. This is termed the “learned-intermediary doctrine.” The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps and in its package insert and the Physician’s Desk Reference. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
Such lawsuits fall in the common category of medical negligence and lack of informed consent, and are not considered a product liability action.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.
2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.
3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).
4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.
5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.
6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).
QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.
Which of the following statements is incorrect?
A. These are all examples of product liability.
B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.
C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.
D. It is now harder to include multiple plaintiffs in a class-action lawsuit.
E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.
ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.1 DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.
The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”2 Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.
At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.
Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.
The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.
Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”
There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.
In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.3 He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.
The California Supreme Court went beyond the law of contracts and negligence by introducing the notion of strict liability, which centers on whether a product is defective and unreasonably dangerous. It holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs.
“Defective” is usually defined as product quality that is less than what a reasonable consumer expects. It can be a design, manufacturing, or marketing defect, the latter instance typically showing up as a failure to warn. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.
Product liability lawsuits commonly involve pharmaceutical products and medical devices. Recent examples are suits against Pfizer over Lipitor’s alleged role as a cause of diabetes and against Johnson & Johnson over its talcum products purportedly causing ovarian cancer.4
When the same product injures multiple plaintiffs, they may band together to file a common legal action against the manufacturer. This is called a class-action suit, and will proceed if it is certified to satisfy four prerequisites: numerosity, commonality, typicality, and adequacy.5 A class-action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.
A recent U.S. Supreme Court decision has, however, put a damper on class-action suits by tightening the jurisdictional requirement.6
The case involved Bristol-Myers Squibb, which was sued in California by several hundred individuals from 33 states for injuries from the platelet inhibitor Plavix (clopidogrel). The issue was whether non–California residents could sue in that state for injuries incurred elsewhere.
In a 8-1 decision, the U.S. Supreme Court held that California courts did not have specific jurisdiction to hear the claims of nonresidents without identifying an adequate link between the state and the nonresidents’ claims, as they weren’t prescribed Plavix in the state, didn’t buy or take the drug there, and weren’t injured by the drug there.
Finally, note that, should a doctor fail to warn an injured patient of a known medication risk, the patient may have a claim against the doctor – but usually not against the drug manufacturer. This is termed the “learned-intermediary doctrine.” The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps and in its package insert and the Physician’s Desk Reference. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
Such lawsuits fall in the common category of medical negligence and lack of informed consent, and are not considered a product liability action.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.
2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.
3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).
4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.
5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.
6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).
QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.
Which of the following statements is incorrect?
A. These are all examples of product liability.
B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.
C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.
D. It is now harder to include multiple plaintiffs in a class-action lawsuit.
E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.
ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.1 DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.
The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”2 Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.
At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.
Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.
The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.
Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”
There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.
In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.3 He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.
The California Supreme Court went beyond the law of contracts and negligence by introducing the notion of strict liability, which centers on whether a product is defective and unreasonably dangerous. It holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs.
“Defective” is usually defined as product quality that is less than what a reasonable consumer expects. It can be a design, manufacturing, or marketing defect, the latter instance typically showing up as a failure to warn. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.
Product liability lawsuits commonly involve pharmaceutical products and medical devices. Recent examples are suits against Pfizer over Lipitor’s alleged role as a cause of diabetes and against Johnson & Johnson over its talcum products purportedly causing ovarian cancer.4
When the same product injures multiple plaintiffs, they may band together to file a common legal action against the manufacturer. This is called a class-action suit, and will proceed if it is certified to satisfy four prerequisites: numerosity, commonality, typicality, and adequacy.5 A class-action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.
A recent U.S. Supreme Court decision has, however, put a damper on class-action suits by tightening the jurisdictional requirement.6
The case involved Bristol-Myers Squibb, which was sued in California by several hundred individuals from 33 states for injuries from the platelet inhibitor Plavix (clopidogrel). The issue was whether non–California residents could sue in that state for injuries incurred elsewhere.
In a 8-1 decision, the U.S. Supreme Court held that California courts did not have specific jurisdiction to hear the claims of nonresidents without identifying an adequate link between the state and the nonresidents’ claims, as they weren’t prescribed Plavix in the state, didn’t buy or take the drug there, and weren’t injured by the drug there.
Finally, note that, should a doctor fail to warn an injured patient of a known medication risk, the patient may have a claim against the doctor – but usually not against the drug manufacturer. This is termed the “learned-intermediary doctrine.” The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps and in its package insert and the Physician’s Desk Reference. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
Such lawsuits fall in the common category of medical negligence and lack of informed consent, and are not considered a product liability action.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.
2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.
3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).
4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.
5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.
6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).
CME: Current Trends in Multiple Myeloma: Customizing Treatment Strategies and Optimizing Outcomes
Click here to read the digital edition of the supplement
This supplement is supported by an educational education grant from Celgene and Janssen Biotech, Inc.
Topics Include:
- Advances in diagnosis and prognosis
- Management of the newly diagnosed patient
- Treatment advances and current management strategies for relapsed/refractory patients
- Future treatment directions
About the Author
Thomas R. Chauncey, MD, PhD
Associate Professor of Medicine and Oncology
University of Washington
Associate Member
Fred Hutchinson Cancer Research Center
Director, Marrow Transplant Unit
VA Puget Sound Health Care System
Seattle, WA
Click here to read the digital edition of the supplement
Click here to read the digital edition of the supplement
This supplement is supported by an educational education grant from Celgene and Janssen Biotech, Inc.
Topics Include:
- Advances in diagnosis and prognosis
- Management of the newly diagnosed patient
- Treatment advances and current management strategies for relapsed/refractory patients
- Future treatment directions
About the Author
Thomas R. Chauncey, MD, PhD
Associate Professor of Medicine and Oncology
University of Washington
Associate Member
Fred Hutchinson Cancer Research Center
Director, Marrow Transplant Unit
VA Puget Sound Health Care System
Seattle, WA
Click here to read the digital edition of the supplement
Click here to read the digital edition of the supplement
This supplement is supported by an educational education grant from Celgene and Janssen Biotech, Inc.
Topics Include:
- Advances in diagnosis and prognosis
- Management of the newly diagnosed patient
- Treatment advances and current management strategies for relapsed/refractory patients
- Future treatment directions
About the Author
Thomas R. Chauncey, MD, PhD
Associate Professor of Medicine and Oncology
University of Washington
Associate Member
Fred Hutchinson Cancer Research Center
Director, Marrow Transplant Unit
VA Puget Sound Health Care System
Seattle, WA
Click here to read the digital edition of the supplement
Kymriah cost effectiveness depends on long-term outcomes
The cost-effectiveness of tisagenlecleucel (Kymriah) depends on long-term clinical outcomes, which are presently unknown, according to investigators.
If the long-term outcomes are more modest than clinical trials suggest, then payers may be unwilling to cover the costly therapy, reported John K. Lin, MD, of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University, and his colleagues. Lowering the price or setting up an outcomes-based pricing structure may be necessary to get insurers to cover the therapy.
Tisagenlecleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that was approved by the Food and Drug Administration in August 2017 for relapsed or refractory pediatric B-cell acute lymphoblastic leukemia (ALL). In 2018, the FDA expanded the indication for tisagenlecleucel to include adults with relapsed or refractory large B-cell lymphoma, though outcomes from lymphoma trials are not analyzed in the current study.
At a wholesale acquisition cost of $475,000 per infusion, it is the most expensive existing oncology therapy to date, and can be accompanied by expensive, potentially fatal adverse effects. However, clinical trials suggest that tisagenlecleucel can offer years of relapse-free remission, thereby allowing patients to forgo other expensive therapies such as hematopoietic stem cell transplantation (HSCT).
“Although tisagenlecleucel-induced remission rates are promising, compared with those of established therapies (greater than 80% vs. less than 50%), only short-term follow-up data currently exist,” the investigators wrote in the Journal of Clinical Oncology. “Given the high cost and broad applicability in other malignancies of tisagenlecleucel, a pressing question for policy makers, payers, patients, and clinicians is whether the cost of therapy represents reasonable value.”
The study used a Markov model to assess various long-term clinical outcome rates and cost thresholds of tisagenlecleucel. The lifetime cost of therapy was assessed and compared with costs of existing therapies.
The results showed that a 5-year relapse free survival rate of 40% would make the present cost ($475,000) of tisagenlecleucel economically reasonable. In this scenario, the increased life expectancy would be 12.1 years and would result in an additional 5.07 quality-adjusted life years (QALY) gained at a cost of $61,000 per QALY, compared with blinatumomab.
But if long-term outcomes are less favorable, tisagenlecleucel becomes much less cost effective. A 5-year relapse-free survival rate of 20% would drop increased life expectancy to 3.8 years, resulting in 1.80 QALYs gained and raising the cost to $151,000 per QALY.
“Our results suggest that at tisagenlecleucel’s current price and payment structure, its economic value is uncertain,” the investigators wrote.
They suggested a price drop to $200,000 or $350,000, which would allow the drug to remain cost effective even in a worse-case scenario, in which patients relapse and tisagenlecleucel is a bridge to transplant. Another option is to move to outcomes-based pricing. Making payment conditional on 7 months of remission would make the treatment cost effective, according to the analysis.
“Price reductions of tisagenlecleucel or payment only for longer-term remissions would favorably influence cost-effectiveness, even if long-term clinical outcomes are modest,” the investigators wrote.
The study was funded by a Veterans Affairs Office of Academic Affiliations advanced fellowship in health service and research development, and a National Center for Advancing Translational Science Clinical and Translational Science Award. One of the study coauthors reported consulting and research funding from Novartis.
SOURCE: Lin et al. J Clin Oncol. 2018 Sep 13. doi: 10.1200/JCO.2018.79.0642.
The cost-effectiveness of tisagenlecleucel (Kymriah) depends on long-term clinical outcomes, which are presently unknown, according to investigators.
If the long-term outcomes are more modest than clinical trials suggest, then payers may be unwilling to cover the costly therapy, reported John K. Lin, MD, of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University, and his colleagues. Lowering the price or setting up an outcomes-based pricing structure may be necessary to get insurers to cover the therapy.
Tisagenlecleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that was approved by the Food and Drug Administration in August 2017 for relapsed or refractory pediatric B-cell acute lymphoblastic leukemia (ALL). In 2018, the FDA expanded the indication for tisagenlecleucel to include adults with relapsed or refractory large B-cell lymphoma, though outcomes from lymphoma trials are not analyzed in the current study.
At a wholesale acquisition cost of $475,000 per infusion, it is the most expensive existing oncology therapy to date, and can be accompanied by expensive, potentially fatal adverse effects. However, clinical trials suggest that tisagenlecleucel can offer years of relapse-free remission, thereby allowing patients to forgo other expensive therapies such as hematopoietic stem cell transplantation (HSCT).
“Although tisagenlecleucel-induced remission rates are promising, compared with those of established therapies (greater than 80% vs. less than 50%), only short-term follow-up data currently exist,” the investigators wrote in the Journal of Clinical Oncology. “Given the high cost and broad applicability in other malignancies of tisagenlecleucel, a pressing question for policy makers, payers, patients, and clinicians is whether the cost of therapy represents reasonable value.”
The study used a Markov model to assess various long-term clinical outcome rates and cost thresholds of tisagenlecleucel. The lifetime cost of therapy was assessed and compared with costs of existing therapies.
The results showed that a 5-year relapse free survival rate of 40% would make the present cost ($475,000) of tisagenlecleucel economically reasonable. In this scenario, the increased life expectancy would be 12.1 years and would result in an additional 5.07 quality-adjusted life years (QALY) gained at a cost of $61,000 per QALY, compared with blinatumomab.
But if long-term outcomes are less favorable, tisagenlecleucel becomes much less cost effective. A 5-year relapse-free survival rate of 20% would drop increased life expectancy to 3.8 years, resulting in 1.80 QALYs gained and raising the cost to $151,000 per QALY.
“Our results suggest that at tisagenlecleucel’s current price and payment structure, its economic value is uncertain,” the investigators wrote.
They suggested a price drop to $200,000 or $350,000, which would allow the drug to remain cost effective even in a worse-case scenario, in which patients relapse and tisagenlecleucel is a bridge to transplant. Another option is to move to outcomes-based pricing. Making payment conditional on 7 months of remission would make the treatment cost effective, according to the analysis.
“Price reductions of tisagenlecleucel or payment only for longer-term remissions would favorably influence cost-effectiveness, even if long-term clinical outcomes are modest,” the investigators wrote.
The study was funded by a Veterans Affairs Office of Academic Affiliations advanced fellowship in health service and research development, and a National Center for Advancing Translational Science Clinical and Translational Science Award. One of the study coauthors reported consulting and research funding from Novartis.
SOURCE: Lin et al. J Clin Oncol. 2018 Sep 13. doi: 10.1200/JCO.2018.79.0642.
The cost-effectiveness of tisagenlecleucel (Kymriah) depends on long-term clinical outcomes, which are presently unknown, according to investigators.
If the long-term outcomes are more modest than clinical trials suggest, then payers may be unwilling to cover the costly therapy, reported John K. Lin, MD, of the Center for Primary Care and Outcomes Research at Stanford (Calif.) University, and his colleagues. Lowering the price or setting up an outcomes-based pricing structure may be necessary to get insurers to cover the therapy.
Tisagenlecleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that was approved by the Food and Drug Administration in August 2017 for relapsed or refractory pediatric B-cell acute lymphoblastic leukemia (ALL). In 2018, the FDA expanded the indication for tisagenlecleucel to include adults with relapsed or refractory large B-cell lymphoma, though outcomes from lymphoma trials are not analyzed in the current study.
At a wholesale acquisition cost of $475,000 per infusion, it is the most expensive existing oncology therapy to date, and can be accompanied by expensive, potentially fatal adverse effects. However, clinical trials suggest that tisagenlecleucel can offer years of relapse-free remission, thereby allowing patients to forgo other expensive therapies such as hematopoietic stem cell transplantation (HSCT).
“Although tisagenlecleucel-induced remission rates are promising, compared with those of established therapies (greater than 80% vs. less than 50%), only short-term follow-up data currently exist,” the investigators wrote in the Journal of Clinical Oncology. “Given the high cost and broad applicability in other malignancies of tisagenlecleucel, a pressing question for policy makers, payers, patients, and clinicians is whether the cost of therapy represents reasonable value.”
The study used a Markov model to assess various long-term clinical outcome rates and cost thresholds of tisagenlecleucel. The lifetime cost of therapy was assessed and compared with costs of existing therapies.
The results showed that a 5-year relapse free survival rate of 40% would make the present cost ($475,000) of tisagenlecleucel economically reasonable. In this scenario, the increased life expectancy would be 12.1 years and would result in an additional 5.07 quality-adjusted life years (QALY) gained at a cost of $61,000 per QALY, compared with blinatumomab.
But if long-term outcomes are less favorable, tisagenlecleucel becomes much less cost effective. A 5-year relapse-free survival rate of 20% would drop increased life expectancy to 3.8 years, resulting in 1.80 QALYs gained and raising the cost to $151,000 per QALY.
“Our results suggest that at tisagenlecleucel’s current price and payment structure, its economic value is uncertain,” the investigators wrote.
They suggested a price drop to $200,000 or $350,000, which would allow the drug to remain cost effective even in a worse-case scenario, in which patients relapse and tisagenlecleucel is a bridge to transplant. Another option is to move to outcomes-based pricing. Making payment conditional on 7 months of remission would make the treatment cost effective, according to the analysis.
“Price reductions of tisagenlecleucel or payment only for longer-term remissions would favorably influence cost-effectiveness, even if long-term clinical outcomes are modest,” the investigators wrote.
The study was funded by a Veterans Affairs Office of Academic Affiliations advanced fellowship in health service and research development, and a National Center for Advancing Translational Science Clinical and Translational Science Award. One of the study coauthors reported consulting and research funding from Novartis.
SOURCE: Lin et al. J Clin Oncol. 2018 Sep 13. doi: 10.1200/JCO.2018.79.0642.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point:
Major finding: If 40% of patients achieve 5-year remission without relapse, then tisagenlecleucel would cost $61,000 per quality-adjusted life year.
Study details: An economic analysis involving tisagenlecleucel costs and clinical trial outcomes.
Disclosures: The study was funded by a Veterans Affairs Office of Academic Affiliations advanced fellowship in health service and research development, and a National Center for Advancing Translational Science Clinical and Translational Science Award. One study coauthor reported consulting and research funding from Novartis.
Source: Lin JK et al. J Clin Oncol. 2018 Sep 13. doi: 10.1200/JCO.2018.79.0642.
Predictors for worse outcomes in low–disease activity RA remain tough to come by
Disease flares are common but are hard to predict in people with rheumatoid arthritis who achieve low disease activity (LDA), and these flares are “undeniably” associated with worse disease activity, quality of life, and radiographic progression, researchers report in an analysis of a prospectively observed cohort.
First author Katie Bechman, MBChB, of the academic rheumatology department at King’s College London, and her colleagues reported online in the Journal of Rheumatology that nearly one-third of patients with RA in stable LDA states, including remission, had flares during a year of follow-up in the observational prospective REMIRA study, similar to previous reports in cohort studies.
The cohort of 152 patients had 28-joint Disease Activity Scores (DAS28) less than 3.2 for at least 1 month apart, and 66% (n = 97) of the cohort fulfilled DAS28 remission criteria (DAS28 less than 2.6). The authors defined disease flare as a DAS28 increase of more than 1.2, compared with baseline, or a DAS28 increase of more than 0.6, compared with baseline, and concurrent DAS28 of 3.2 or greater. A total of 69 (35%) were taking disease-modifying antirheumatic drug monotherapy.
Nearly one-third of RA patients (30%, n = 46) with LDA states experienced a flare during 12 months of follow-up. When limiting the cohort to patients who were in remission at baseline, 25% (n = 24) had at least one flare.
Patients who had a flare experienced significantly worse clinical outcomes at 12 months than did patients in sustained remission, reflected by higher disease activity, worse functional outcomes, and higher radiographic progression scores.
For example, patients who flared had more than a threefold greater risk for erosive progression, defined as new or larger erosions over 1 year on radiographs (hazard ratio, 3.6; 95% confidence interval, 2.77-4.67; P less than .01).
Patients’ baseline values on the Health Assessment Questionnaire-Disability Index – a measure of functional activity that is reflected by difficulties in activities of daily living – proved to be a significant independent predictor of flare (HR, 1.76; 95% CI, 1.05-2.93; P = .03) in multivariate analyses.
The researchers also found that serum biomarkers were modestly correlated with DAS28 at the time of flare. DAS28 and its components significantly correlated with multibiomarker disease activity score and calprotectin at time of flare, but correlation coefficients were low at 0.52 and 0.49, respectively. Two-thirds of flares were not associated with a rise in biomarkers.
“This might be because a flare is defined by worsening of the DAS28 composite score, and an increase in [tender joint count] and [patient’s global assessment] alone may increase the DAS28 score to a sufficient level to define a flare,” the investigators suggested.
“It is possible that a flare event is not solely the result of direct synovial inflammation but may be driven by other pathways, for example chronification of pain due to central sensitization and abnormal regulatory mechanisms. This heterogeneity may partly explain why identifying predictors of flare is challenging,” they said.
“In our study, we have shown that the occurrence of a flare is hard to predict, but undeniably associated with worse clinical outcomes at 12 months,” the researchers concluded.
They suggested that it was possible that two “distinct subtypes” of flare might exist: an “inflammatory” flare that was predominantly driven by an increase in swollen joint count and erythrocyte sedimentation rate, and a “noninflammatory” flare with a disproportionately elevated tender joint count and a high patient global assessment score.
“Differentiating these two flare types may identify potential predictors. Further research is needed to determine whether distinct flares exist and to categorize the potential predictors of each,” they added.
The research was partly funded by the U.K. National Institute for Health Research Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London.
SOURCE: Bechman K et al. J Rheumatol. 2018 Sep 1. doi: 10.3899/jrheum.171375.
Disease flares are common but are hard to predict in people with rheumatoid arthritis who achieve low disease activity (LDA), and these flares are “undeniably” associated with worse disease activity, quality of life, and radiographic progression, researchers report in an analysis of a prospectively observed cohort.
First author Katie Bechman, MBChB, of the academic rheumatology department at King’s College London, and her colleagues reported online in the Journal of Rheumatology that nearly one-third of patients with RA in stable LDA states, including remission, had flares during a year of follow-up in the observational prospective REMIRA study, similar to previous reports in cohort studies.
The cohort of 152 patients had 28-joint Disease Activity Scores (DAS28) less than 3.2 for at least 1 month apart, and 66% (n = 97) of the cohort fulfilled DAS28 remission criteria (DAS28 less than 2.6). The authors defined disease flare as a DAS28 increase of more than 1.2, compared with baseline, or a DAS28 increase of more than 0.6, compared with baseline, and concurrent DAS28 of 3.2 or greater. A total of 69 (35%) were taking disease-modifying antirheumatic drug monotherapy.
Nearly one-third of RA patients (30%, n = 46) with LDA states experienced a flare during 12 months of follow-up. When limiting the cohort to patients who were in remission at baseline, 25% (n = 24) had at least one flare.
Patients who had a flare experienced significantly worse clinical outcomes at 12 months than did patients in sustained remission, reflected by higher disease activity, worse functional outcomes, and higher radiographic progression scores.
For example, patients who flared had more than a threefold greater risk for erosive progression, defined as new or larger erosions over 1 year on radiographs (hazard ratio, 3.6; 95% confidence interval, 2.77-4.67; P less than .01).
Patients’ baseline values on the Health Assessment Questionnaire-Disability Index – a measure of functional activity that is reflected by difficulties in activities of daily living – proved to be a significant independent predictor of flare (HR, 1.76; 95% CI, 1.05-2.93; P = .03) in multivariate analyses.
The researchers also found that serum biomarkers were modestly correlated with DAS28 at the time of flare. DAS28 and its components significantly correlated with multibiomarker disease activity score and calprotectin at time of flare, but correlation coefficients were low at 0.52 and 0.49, respectively. Two-thirds of flares were not associated with a rise in biomarkers.
“This might be because a flare is defined by worsening of the DAS28 composite score, and an increase in [tender joint count] and [patient’s global assessment] alone may increase the DAS28 score to a sufficient level to define a flare,” the investigators suggested.
“It is possible that a flare event is not solely the result of direct synovial inflammation but may be driven by other pathways, for example chronification of pain due to central sensitization and abnormal regulatory mechanisms. This heterogeneity may partly explain why identifying predictors of flare is challenging,” they said.
“In our study, we have shown that the occurrence of a flare is hard to predict, but undeniably associated with worse clinical outcomes at 12 months,” the researchers concluded.
They suggested that it was possible that two “distinct subtypes” of flare might exist: an “inflammatory” flare that was predominantly driven by an increase in swollen joint count and erythrocyte sedimentation rate, and a “noninflammatory” flare with a disproportionately elevated tender joint count and a high patient global assessment score.
“Differentiating these two flare types may identify potential predictors. Further research is needed to determine whether distinct flares exist and to categorize the potential predictors of each,” they added.
The research was partly funded by the U.K. National Institute for Health Research Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London.
SOURCE: Bechman K et al. J Rheumatol. 2018 Sep 1. doi: 10.3899/jrheum.171375.
Disease flares are common but are hard to predict in people with rheumatoid arthritis who achieve low disease activity (LDA), and these flares are “undeniably” associated with worse disease activity, quality of life, and radiographic progression, researchers report in an analysis of a prospectively observed cohort.
First author Katie Bechman, MBChB, of the academic rheumatology department at King’s College London, and her colleagues reported online in the Journal of Rheumatology that nearly one-third of patients with RA in stable LDA states, including remission, had flares during a year of follow-up in the observational prospective REMIRA study, similar to previous reports in cohort studies.
The cohort of 152 patients had 28-joint Disease Activity Scores (DAS28) less than 3.2 for at least 1 month apart, and 66% (n = 97) of the cohort fulfilled DAS28 remission criteria (DAS28 less than 2.6). The authors defined disease flare as a DAS28 increase of more than 1.2, compared with baseline, or a DAS28 increase of more than 0.6, compared with baseline, and concurrent DAS28 of 3.2 or greater. A total of 69 (35%) were taking disease-modifying antirheumatic drug monotherapy.
Nearly one-third of RA patients (30%, n = 46) with LDA states experienced a flare during 12 months of follow-up. When limiting the cohort to patients who were in remission at baseline, 25% (n = 24) had at least one flare.
Patients who had a flare experienced significantly worse clinical outcomes at 12 months than did patients in sustained remission, reflected by higher disease activity, worse functional outcomes, and higher radiographic progression scores.
For example, patients who flared had more than a threefold greater risk for erosive progression, defined as new or larger erosions over 1 year on radiographs (hazard ratio, 3.6; 95% confidence interval, 2.77-4.67; P less than .01).
Patients’ baseline values on the Health Assessment Questionnaire-Disability Index – a measure of functional activity that is reflected by difficulties in activities of daily living – proved to be a significant independent predictor of flare (HR, 1.76; 95% CI, 1.05-2.93; P = .03) in multivariate analyses.
The researchers also found that serum biomarkers were modestly correlated with DAS28 at the time of flare. DAS28 and its components significantly correlated with multibiomarker disease activity score and calprotectin at time of flare, but correlation coefficients were low at 0.52 and 0.49, respectively. Two-thirds of flares were not associated with a rise in biomarkers.
“This might be because a flare is defined by worsening of the DAS28 composite score, and an increase in [tender joint count] and [patient’s global assessment] alone may increase the DAS28 score to a sufficient level to define a flare,” the investigators suggested.
“It is possible that a flare event is not solely the result of direct synovial inflammation but may be driven by other pathways, for example chronification of pain due to central sensitization and abnormal regulatory mechanisms. This heterogeneity may partly explain why identifying predictors of flare is challenging,” they said.
“In our study, we have shown that the occurrence of a flare is hard to predict, but undeniably associated with worse clinical outcomes at 12 months,” the researchers concluded.
They suggested that it was possible that two “distinct subtypes” of flare might exist: an “inflammatory” flare that was predominantly driven by an increase in swollen joint count and erythrocyte sedimentation rate, and a “noninflammatory” flare with a disproportionately elevated tender joint count and a high patient global assessment score.
“Differentiating these two flare types may identify potential predictors. Further research is needed to determine whether distinct flares exist and to categorize the potential predictors of each,” they added.
The research was partly funded by the U.K. National Institute for Health Research Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London.
SOURCE: Bechman K et al. J Rheumatol. 2018 Sep 1. doi: 10.3899/jrheum.171375.
FROM THE JOURNAL OF RHEUMATOLOGY
Key clinical point: Flares occur frequently in RA patients with low disease activity and are associated with worse disease activity, quality of life, and radiographic progression.
Major finding:
Study details: A study of 152 RA patients taking part in the observational prospective REMIRA study who had a stable 28-joint Disease Activity Score (DAS28) less than 3.2.
Disclosures: The research was partly funded by the U.K. National Institute for Health Research Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London.
Source: Bechman K et al. J Rheumatol. 2018 Sep 1. doi: 10.3899/jrheum.171375.
Pediatric hypertension linked to troubling MRI changes
CHICAGO – There’s another reason to worry about hypertension in children: cognitive decline later in life.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In a pilot study, Marc Lande, MD, a professor of pediatric nephrology at the University of Rochester (N.Y.), and his colleagues found similar to what’s found in adults with cognitive impairment from hypertension.
The work is ongoing, but it helps explain the subtle deficits on cognitive testing that have been previously demonstrated in children with hypertension.
“The fact that we are finding anything at this very early stage of disease is striking and somewhat bothersome. The hope is that, by improving blood pressure in children, you can improve subsequent cognition and maybe even delay the onset of dementia further down the road,” Dr. Lande said.
For now, the findings underscore the need to diagnose and manage hypertension in children, but there might be additional treatment implications in the future, especially if blood pressure targets are found that ameliorate the problem.
Dr. Lande explained the issues and the emerging evidence in a video interview at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
CHICAGO – There’s another reason to worry about hypertension in children: cognitive decline later in life.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In a pilot study, Marc Lande, MD, a professor of pediatric nephrology at the University of Rochester (N.Y.), and his colleagues found similar to what’s found in adults with cognitive impairment from hypertension.
The work is ongoing, but it helps explain the subtle deficits on cognitive testing that have been previously demonstrated in children with hypertension.
“The fact that we are finding anything at this very early stage of disease is striking and somewhat bothersome. The hope is that, by improving blood pressure in children, you can improve subsequent cognition and maybe even delay the onset of dementia further down the road,” Dr. Lande said.
For now, the findings underscore the need to diagnose and manage hypertension in children, but there might be additional treatment implications in the future, especially if blood pressure targets are found that ameliorate the problem.
Dr. Lande explained the issues and the emerging evidence in a video interview at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
CHICAGO – There’s another reason to worry about hypertension in children: cognitive decline later in life.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
In a pilot study, Marc Lande, MD, a professor of pediatric nephrology at the University of Rochester (N.Y.), and his colleagues found similar to what’s found in adults with cognitive impairment from hypertension.
The work is ongoing, but it helps explain the subtle deficits on cognitive testing that have been previously demonstrated in children with hypertension.
“The fact that we are finding anything at this very early stage of disease is striking and somewhat bothersome. The hope is that, by improving blood pressure in children, you can improve subsequent cognition and maybe even delay the onset of dementia further down the road,” Dr. Lande said.
For now, the findings underscore the need to diagnose and manage hypertension in children, but there might be additional treatment implications in the future, especially if blood pressure targets are found that ameliorate the problem.
Dr. Lande explained the issues and the emerging evidence in a video interview at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
REPORTING FROM JOINT HYPERTENSION 2018
Dupilumab efficacy extends to chronic rhinosinusitis/nasal polyposis
PARIS – Severe asthma patients with chronic rhinosinusitis (CRS), nasal polyposis (NP), or both derive more protection from severe exacerbations with the monoclonal antibody dupilumab than do those who do not have these comorbidities, according to a post hoc analysis of a phase 3 trial presented at the annual congress of the European Respiratory Society.
“Dupilumab reduced rates of severe exacerbations and improved FEV1 [forced expiratory volume in 1 second] in patients in asthma patients with or without CRS/NP. In those with CRS/NP, dupilumab reduced symptoms associated with these comorbidities,” reported Ian Pavord, MBBS, statutory chair in respiratory medicine at University of Oxford (England).
The data were drawn from the phase 3 Liberty Asthma Quest trial, which was published earlier this year in the New England Journal of Medicine (2018;378:2486-96). In that study, both the 200-mg and 300-mg dose of dupilumab (Dupixent) administered every 2 weeks was associated with about a 50% reduction in the annualized rate of severe exacerbations relative to placebo (P less than .001 for both doses).
In this new post hoc analysis, response in the 382 patients who entered the study with a history of CRS/NP was compared with the 1,520 without CRS/NP. In the CRS/NP patients, the reductions relative to placebo in the rates of severe exacerbations, defined as 3 or more days of systemic glucocorticoids or visit to an emergency department leading to treatment with systemic glucocorticoids, were 63% and 61% for the 200-mg and 300-mg doses of dupilumab, respectively (both P less than .001).
In the non-CRS/NP arms, the reductions relative to placebo were 42% and 40%, respectively (both P less than .001). The greater relative reductions in the CRS/NP patients were achieved even though they were older (mean age approximately 52 vs. 47 years for non-CRS/NP patients), had a significantly greater number of exacerbations in the past year (P = .027), and had higher baseline fractional exhaled nitric oxide and eosinophil levels (both P less than .001), Dr. Pavord reported.
“The greater asthma severity in the CRS/NP patients in this trial is consistent with that reported previously by others,” Dr. Pavord said.
Although the greater asthma severity may have provided a larger margin for benefit, Dr. Pavord also reported that there were improvements in CRS/NP-specific symptoms as measured with the 22-item Sino-Nasal Outcome Test (SNOT-22). By week 12, the total score reduction in SNOT-22 was approximately 15 points (P less than .05) from baseline for both the 200-mg and 300-mg dupilumab doses. This was significantly greater (P less than .05) relative to modest SNOT-22 reductions in the placebo arms (P less than .05). After 52 weeks, the reduction In SNOT-22 scores were sustained, providing an even greater statistical advantage over placebo (P less than .001).
In addition to greater protection against severe exacerbations and CRS/NP-specific symptoms, dupilumab may offer specific improvements on CRS/NP pathology, according to Dr. Pavord. Although imaging was not part of this study, he noted in particular that previous studies with dupilumab as well as other biologics have shown shrinkage of nasal polyps with treatment.
Dupilumab was similarly well tolerated in those with and without CRS/NP. The most common adverse event was injection site reactions in both groups, Dr. Pavord said.
Calling CRS and NP “important comorbidities” in severe asthma patients, Dr. Pavord said that this analysis should be reassuring for those who with CRS/NP who are being considered for dupilumab. Already approved for treatment of atopic dermatitis, dupilumab, which binds to interleukin-4 (IL-4) and IL-13 receptors, is currently under review for the treatment of moderate to severe asthma.
Dr. Pavord has financial relationships with Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Knapp, Merck Sharpe, Novartis, Knapp Teva, RespiVert, and Schering-Plough.
PARIS – Severe asthma patients with chronic rhinosinusitis (CRS), nasal polyposis (NP), or both derive more protection from severe exacerbations with the monoclonal antibody dupilumab than do those who do not have these comorbidities, according to a post hoc analysis of a phase 3 trial presented at the annual congress of the European Respiratory Society.
“Dupilumab reduced rates of severe exacerbations and improved FEV1 [forced expiratory volume in 1 second] in patients in asthma patients with or without CRS/NP. In those with CRS/NP, dupilumab reduced symptoms associated with these comorbidities,” reported Ian Pavord, MBBS, statutory chair in respiratory medicine at University of Oxford (England).
The data were drawn from the phase 3 Liberty Asthma Quest trial, which was published earlier this year in the New England Journal of Medicine (2018;378:2486-96). In that study, both the 200-mg and 300-mg dose of dupilumab (Dupixent) administered every 2 weeks was associated with about a 50% reduction in the annualized rate of severe exacerbations relative to placebo (P less than .001 for both doses).
In this new post hoc analysis, response in the 382 patients who entered the study with a history of CRS/NP was compared with the 1,520 without CRS/NP. In the CRS/NP patients, the reductions relative to placebo in the rates of severe exacerbations, defined as 3 or more days of systemic glucocorticoids or visit to an emergency department leading to treatment with systemic glucocorticoids, were 63% and 61% for the 200-mg and 300-mg doses of dupilumab, respectively (both P less than .001).
In the non-CRS/NP arms, the reductions relative to placebo were 42% and 40%, respectively (both P less than .001). The greater relative reductions in the CRS/NP patients were achieved even though they were older (mean age approximately 52 vs. 47 years for non-CRS/NP patients), had a significantly greater number of exacerbations in the past year (P = .027), and had higher baseline fractional exhaled nitric oxide and eosinophil levels (both P less than .001), Dr. Pavord reported.
“The greater asthma severity in the CRS/NP patients in this trial is consistent with that reported previously by others,” Dr. Pavord said.
Although the greater asthma severity may have provided a larger margin for benefit, Dr. Pavord also reported that there were improvements in CRS/NP-specific symptoms as measured with the 22-item Sino-Nasal Outcome Test (SNOT-22). By week 12, the total score reduction in SNOT-22 was approximately 15 points (P less than .05) from baseline for both the 200-mg and 300-mg dupilumab doses. This was significantly greater (P less than .05) relative to modest SNOT-22 reductions in the placebo arms (P less than .05). After 52 weeks, the reduction In SNOT-22 scores were sustained, providing an even greater statistical advantage over placebo (P less than .001).
In addition to greater protection against severe exacerbations and CRS/NP-specific symptoms, dupilumab may offer specific improvements on CRS/NP pathology, according to Dr. Pavord. Although imaging was not part of this study, he noted in particular that previous studies with dupilumab as well as other biologics have shown shrinkage of nasal polyps with treatment.
Dupilumab was similarly well tolerated in those with and without CRS/NP. The most common adverse event was injection site reactions in both groups, Dr. Pavord said.
Calling CRS and NP “important comorbidities” in severe asthma patients, Dr. Pavord said that this analysis should be reassuring for those who with CRS/NP who are being considered for dupilumab. Already approved for treatment of atopic dermatitis, dupilumab, which binds to interleukin-4 (IL-4) and IL-13 receptors, is currently under review for the treatment of moderate to severe asthma.
Dr. Pavord has financial relationships with Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Knapp, Merck Sharpe, Novartis, Knapp Teva, RespiVert, and Schering-Plough.
PARIS – Severe asthma patients with chronic rhinosinusitis (CRS), nasal polyposis (NP), or both derive more protection from severe exacerbations with the monoclonal antibody dupilumab than do those who do not have these comorbidities, according to a post hoc analysis of a phase 3 trial presented at the annual congress of the European Respiratory Society.
“Dupilumab reduced rates of severe exacerbations and improved FEV1 [forced expiratory volume in 1 second] in patients in asthma patients with or without CRS/NP. In those with CRS/NP, dupilumab reduced symptoms associated with these comorbidities,” reported Ian Pavord, MBBS, statutory chair in respiratory medicine at University of Oxford (England).
The data were drawn from the phase 3 Liberty Asthma Quest trial, which was published earlier this year in the New England Journal of Medicine (2018;378:2486-96). In that study, both the 200-mg and 300-mg dose of dupilumab (Dupixent) administered every 2 weeks was associated with about a 50% reduction in the annualized rate of severe exacerbations relative to placebo (P less than .001 for both doses).
In this new post hoc analysis, response in the 382 patients who entered the study with a history of CRS/NP was compared with the 1,520 without CRS/NP. In the CRS/NP patients, the reductions relative to placebo in the rates of severe exacerbations, defined as 3 or more days of systemic glucocorticoids or visit to an emergency department leading to treatment with systemic glucocorticoids, were 63% and 61% for the 200-mg and 300-mg doses of dupilumab, respectively (both P less than .001).
In the non-CRS/NP arms, the reductions relative to placebo were 42% and 40%, respectively (both P less than .001). The greater relative reductions in the CRS/NP patients were achieved even though they were older (mean age approximately 52 vs. 47 years for non-CRS/NP patients), had a significantly greater number of exacerbations in the past year (P = .027), and had higher baseline fractional exhaled nitric oxide and eosinophil levels (both P less than .001), Dr. Pavord reported.
“The greater asthma severity in the CRS/NP patients in this trial is consistent with that reported previously by others,” Dr. Pavord said.
Although the greater asthma severity may have provided a larger margin for benefit, Dr. Pavord also reported that there were improvements in CRS/NP-specific symptoms as measured with the 22-item Sino-Nasal Outcome Test (SNOT-22). By week 12, the total score reduction in SNOT-22 was approximately 15 points (P less than .05) from baseline for both the 200-mg and 300-mg dupilumab doses. This was significantly greater (P less than .05) relative to modest SNOT-22 reductions in the placebo arms (P less than .05). After 52 weeks, the reduction In SNOT-22 scores were sustained, providing an even greater statistical advantage over placebo (P less than .001).
In addition to greater protection against severe exacerbations and CRS/NP-specific symptoms, dupilumab may offer specific improvements on CRS/NP pathology, according to Dr. Pavord. Although imaging was not part of this study, he noted in particular that previous studies with dupilumab as well as other biologics have shown shrinkage of nasal polyps with treatment.
Dupilumab was similarly well tolerated in those with and without CRS/NP. The most common adverse event was injection site reactions in both groups, Dr. Pavord said.
Calling CRS and NP “important comorbidities” in severe asthma patients, Dr. Pavord said that this analysis should be reassuring for those who with CRS/NP who are being considered for dupilumab. Already approved for treatment of atopic dermatitis, dupilumab, which binds to interleukin-4 (IL-4) and IL-13 receptors, is currently under review for the treatment of moderate to severe asthma.
Dr. Pavord has financial relationships with Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Knapp, Merck Sharpe, Novartis, Knapp Teva, RespiVert, and Schering-Plough.
REPORTING FROM THE ERS CONGRESS 2018
Key clinical point: In asthma patients with chronic rhinosinusitis and/or nasal polyposis (CRS/NP), dupilumab reduces exacerbations.
Major finding: At 52 weeks, severe exacerbations were reduced 61% in CRS/NP patients and 40% in non-CRS/NP patients (both P less than .001).
Study details: Post hoc analysis of phase 3 trial.
Disclosures: Dr. Pavord has financial relationships with Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Knapp, Merck Sharpe, Novartis, Knapp Teva, RespiVert, and Schering-Plough.
Updated IPF guideline refines diagnostic criteria with HRCT
A recently updated guideline for idiopathic pulmonary fibrosis (IPF) provides refined diagnostic criteria in an effort to improve clinical application and diagnostic accuracy.
Of note, the guideline recommends that high-resolution CT (HRCT) patterns be used to dictate management course. The guideline also calls for detailed medical history, serological testing to exclude connective tissue disease, and multidisciplinary discussion. Serum biomarkers are recommended against as a means of distinguishing between IPF and other interstitial lung diseases (ILDs).
“Diagnosing IPF is challenging because these symptoms are nonspecific: They occur with all other interstitial lung diseases and with other respiratory problems,” Ganesh Raghu, MD, chair of the guideline committee and professor of medicine and director of the Center for Interstitial Lung Disease at the University of Washington, Seattle, said in a written statement. “Because drugs may slow the progression of IPF, an early and accurate diagnosis is essential for prompt and appropriate treatment for this fatal disease.”
The 2018 guideline represents a second collaborative effort from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. The guideline committee consisted of 29 clinicians, scientists, and a patient with IPF. They evaluated all IPF-related evidence and rated the quality of findings with the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. The first IPF guideline was published 7 years ago; the intervening time has revealed some clinical limitations that the 2018 guideline aims to fix.
“The 2011 guideline provided the first evidence-based, formal criteria for diagnosis of IPF and allowed patients with a well-defined diagnosis of IPF to participate in numerous clinical studies and randomized controlled trials that enhanced our understanding of the disease,” Dr. Raghu said. “However, it became clear that there were significant challenges in ascertaining the diagnosis per the 2011 criteria, and abundant evidence accumulated since then allowed the committee to refine the diagnostic criteria now.”
“This [updated] guideline is intended to help clinicians make an accurate diagnosis of IPF,” the authors wrote in the American Journal of Respiratory and Critical Care Medicine, “and to empower them to implement recommended courses of action in the context of individual patient values and preferences, particularly decisions regarding which diagnostic interventions to pursue.”
While the 2011 guideline did not distinguish between patients with different HRCT patterns, the 2018 guideline emphasizes the use of HRCT. It is now recommended that patients undergo HRCT to determine the pattern of usual interstitial pneumonia (UIP). Broadly, patients exhibit the UIP pattern or one of three possible non-UIP patterns (probable UIP, indeterminate UIP, or an alternative diagnosis). Recommendations are specific for UIP and non-UIP.
Patients with probable UIP, indeterminate UIP, or an alternative diagnosis should undergo bronchoalveolar lavage (BAL) and surgical lung biopsy (SLB). Transbronchial lung biopsy (TBBx) and lung cryobiopsy recommendations were not described in these patients because of a lack of evidence. However, patients with UIP should not undergo BAL, SLB, TBBx, or cryobiopsy.
For all patients, the 2018 guideline recommends that medical histories include environmental exposure and medication use, and that serological testing is performed to exclude connective tissue disease. Multidisciplinary discussion is conditionally recommended for diagnostic decision making, particularly when a patient has probable UIP, indeterminate UIP, or an alternative diagnosis.
Finally, the guideline recommends against the use of serum biomarkers as a means of distinguishing between IPF and other ILDs because of weak data on this point. “For the time being, the guideline panel dismissed serum biomarker measurement as an approach to distinguishing IPF from other ILDs because of the high false-positive and false-negative result rates,” the panel wrote.
“Our hope is that this new guideline will bridge the gap between the experienced IPF experts and general pulmonologists in making a prompt and accurate diagnosis of IPF for the individual unfortunately confronted with the disease,” Dr. Raghu said. “This will allow patients to make well-informed decisions about treatment options and participation in clinical trials.”
Looking to the future, the panel described an “urgent need to refine and validate diagnostic approaches to ILD. These needs can be roughly categorized as investigations into the roles of clinical observations, HRCT, bronchoscopy, histopathology, and biomarkers.” The authors also emphasized “the need to refine prognostic approaches, identify risk factors for the development of IPF, and determine the impact and approach to the diagnosis of comorbid illness in the patient with IPF.”
The authors reported funding from Bellerophon, Gilead, Roche, Sanofi, and others.
SOURCE: Raghu G et al. Am J Respir Crit Care Med. 2018 Sep 1. doi: 10.1164/rccm.201807-1255ST.
A recently updated guideline for idiopathic pulmonary fibrosis (IPF) provides refined diagnostic criteria in an effort to improve clinical application and diagnostic accuracy.
Of note, the guideline recommends that high-resolution CT (HRCT) patterns be used to dictate management course. The guideline also calls for detailed medical history, serological testing to exclude connective tissue disease, and multidisciplinary discussion. Serum biomarkers are recommended against as a means of distinguishing between IPF and other interstitial lung diseases (ILDs).
“Diagnosing IPF is challenging because these symptoms are nonspecific: They occur with all other interstitial lung diseases and with other respiratory problems,” Ganesh Raghu, MD, chair of the guideline committee and professor of medicine and director of the Center for Interstitial Lung Disease at the University of Washington, Seattle, said in a written statement. “Because drugs may slow the progression of IPF, an early and accurate diagnosis is essential for prompt and appropriate treatment for this fatal disease.”
The 2018 guideline represents a second collaborative effort from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. The guideline committee consisted of 29 clinicians, scientists, and a patient with IPF. They evaluated all IPF-related evidence and rated the quality of findings with the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. The first IPF guideline was published 7 years ago; the intervening time has revealed some clinical limitations that the 2018 guideline aims to fix.
“The 2011 guideline provided the first evidence-based, formal criteria for diagnosis of IPF and allowed patients with a well-defined diagnosis of IPF to participate in numerous clinical studies and randomized controlled trials that enhanced our understanding of the disease,” Dr. Raghu said. “However, it became clear that there were significant challenges in ascertaining the diagnosis per the 2011 criteria, and abundant evidence accumulated since then allowed the committee to refine the diagnostic criteria now.”
“This [updated] guideline is intended to help clinicians make an accurate diagnosis of IPF,” the authors wrote in the American Journal of Respiratory and Critical Care Medicine, “and to empower them to implement recommended courses of action in the context of individual patient values and preferences, particularly decisions regarding which diagnostic interventions to pursue.”
While the 2011 guideline did not distinguish between patients with different HRCT patterns, the 2018 guideline emphasizes the use of HRCT. It is now recommended that patients undergo HRCT to determine the pattern of usual interstitial pneumonia (UIP). Broadly, patients exhibit the UIP pattern or one of three possible non-UIP patterns (probable UIP, indeterminate UIP, or an alternative diagnosis). Recommendations are specific for UIP and non-UIP.
Patients with probable UIP, indeterminate UIP, or an alternative diagnosis should undergo bronchoalveolar lavage (BAL) and surgical lung biopsy (SLB). Transbronchial lung biopsy (TBBx) and lung cryobiopsy recommendations were not described in these patients because of a lack of evidence. However, patients with UIP should not undergo BAL, SLB, TBBx, or cryobiopsy.
For all patients, the 2018 guideline recommends that medical histories include environmental exposure and medication use, and that serological testing is performed to exclude connective tissue disease. Multidisciplinary discussion is conditionally recommended for diagnostic decision making, particularly when a patient has probable UIP, indeterminate UIP, or an alternative diagnosis.
Finally, the guideline recommends against the use of serum biomarkers as a means of distinguishing between IPF and other ILDs because of weak data on this point. “For the time being, the guideline panel dismissed serum biomarker measurement as an approach to distinguishing IPF from other ILDs because of the high false-positive and false-negative result rates,” the panel wrote.
“Our hope is that this new guideline will bridge the gap between the experienced IPF experts and general pulmonologists in making a prompt and accurate diagnosis of IPF for the individual unfortunately confronted with the disease,” Dr. Raghu said. “This will allow patients to make well-informed decisions about treatment options and participation in clinical trials.”
Looking to the future, the panel described an “urgent need to refine and validate diagnostic approaches to ILD. These needs can be roughly categorized as investigations into the roles of clinical observations, HRCT, bronchoscopy, histopathology, and biomarkers.” The authors also emphasized “the need to refine prognostic approaches, identify risk factors for the development of IPF, and determine the impact and approach to the diagnosis of comorbid illness in the patient with IPF.”
The authors reported funding from Bellerophon, Gilead, Roche, Sanofi, and others.
SOURCE: Raghu G et al. Am J Respir Crit Care Med. 2018 Sep 1. doi: 10.1164/rccm.201807-1255ST.
A recently updated guideline for idiopathic pulmonary fibrosis (IPF) provides refined diagnostic criteria in an effort to improve clinical application and diagnostic accuracy.
Of note, the guideline recommends that high-resolution CT (HRCT) patterns be used to dictate management course. The guideline also calls for detailed medical history, serological testing to exclude connective tissue disease, and multidisciplinary discussion. Serum biomarkers are recommended against as a means of distinguishing between IPF and other interstitial lung diseases (ILDs).
“Diagnosing IPF is challenging because these symptoms are nonspecific: They occur with all other interstitial lung diseases and with other respiratory problems,” Ganesh Raghu, MD, chair of the guideline committee and professor of medicine and director of the Center for Interstitial Lung Disease at the University of Washington, Seattle, said in a written statement. “Because drugs may slow the progression of IPF, an early and accurate diagnosis is essential for prompt and appropriate treatment for this fatal disease.”
The 2018 guideline represents a second collaborative effort from the American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. The guideline committee consisted of 29 clinicians, scientists, and a patient with IPF. They evaluated all IPF-related evidence and rated the quality of findings with the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. The first IPF guideline was published 7 years ago; the intervening time has revealed some clinical limitations that the 2018 guideline aims to fix.
“The 2011 guideline provided the first evidence-based, formal criteria for diagnosis of IPF and allowed patients with a well-defined diagnosis of IPF to participate in numerous clinical studies and randomized controlled trials that enhanced our understanding of the disease,” Dr. Raghu said. “However, it became clear that there were significant challenges in ascertaining the diagnosis per the 2011 criteria, and abundant evidence accumulated since then allowed the committee to refine the diagnostic criteria now.”
“This [updated] guideline is intended to help clinicians make an accurate diagnosis of IPF,” the authors wrote in the American Journal of Respiratory and Critical Care Medicine, “and to empower them to implement recommended courses of action in the context of individual patient values and preferences, particularly decisions regarding which diagnostic interventions to pursue.”
While the 2011 guideline did not distinguish between patients with different HRCT patterns, the 2018 guideline emphasizes the use of HRCT. It is now recommended that patients undergo HRCT to determine the pattern of usual interstitial pneumonia (UIP). Broadly, patients exhibit the UIP pattern or one of three possible non-UIP patterns (probable UIP, indeterminate UIP, or an alternative diagnosis). Recommendations are specific for UIP and non-UIP.
Patients with probable UIP, indeterminate UIP, or an alternative diagnosis should undergo bronchoalveolar lavage (BAL) and surgical lung biopsy (SLB). Transbronchial lung biopsy (TBBx) and lung cryobiopsy recommendations were not described in these patients because of a lack of evidence. However, patients with UIP should not undergo BAL, SLB, TBBx, or cryobiopsy.
For all patients, the 2018 guideline recommends that medical histories include environmental exposure and medication use, and that serological testing is performed to exclude connective tissue disease. Multidisciplinary discussion is conditionally recommended for diagnostic decision making, particularly when a patient has probable UIP, indeterminate UIP, or an alternative diagnosis.
Finally, the guideline recommends against the use of serum biomarkers as a means of distinguishing between IPF and other ILDs because of weak data on this point. “For the time being, the guideline panel dismissed serum biomarker measurement as an approach to distinguishing IPF from other ILDs because of the high false-positive and false-negative result rates,” the panel wrote.
“Our hope is that this new guideline will bridge the gap between the experienced IPF experts and general pulmonologists in making a prompt and accurate diagnosis of IPF for the individual unfortunately confronted with the disease,” Dr. Raghu said. “This will allow patients to make well-informed decisions about treatment options and participation in clinical trials.”
Looking to the future, the panel described an “urgent need to refine and validate diagnostic approaches to ILD. These needs can be roughly categorized as investigations into the roles of clinical observations, HRCT, bronchoscopy, histopathology, and biomarkers.” The authors also emphasized “the need to refine prognostic approaches, identify risk factors for the development of IPF, and determine the impact and approach to the diagnosis of comorbid illness in the patient with IPF.”
The authors reported funding from Bellerophon, Gilead, Roche, Sanofi, and others.
SOURCE: Raghu G et al. Am J Respir Crit Care Med. 2018 Sep 1. doi: 10.1164/rccm.201807-1255ST.
FROM THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Hospitalist movers and shakers – Sept. 2018
Modern Healthcare recently announced its list of the 50 Most Influential Physician Executives and Leaders, and hospital medicine was well represented among the honorees. The honored physicians were selected by a panel of experts and peers for their leadership and impact on the profession.
Topping the list was Scott Gottlieb, MD, the commissioner of the Food and Drug Administration. Dr. Gottlieb was confirmed to his position in May 2017 and, in his first year, has focused on price transparency and the approval of generic medications.
Dr. Gottlieb was deputy commissioner of the FDA from 2005-2007, and he has worked as an advisor and analyst for GlaxoSmithKline, the American Enterprise Institute, Vertex Pharmaceuticals, and Avilene Health.
Dr. Gottlieb earned his medical degree from the Icahn School of Medicine at Mount Sinai, New York, and completed his residency at Mount Sinai Hospital. He has worked as a hospitalist at New York University’s Tisch Hospital, the Hospital for Joint Diseases, and Stamford (Conn.) Hospital.
Patrick Conway, MD, was listed at number 23 on Modern Healthcare’s 50 Most Influential Physician Executives and Leaders. Formerly the deputy administrator for innovation and quality at the Centers for Medicare & Medicaid Services, Dr. Conway recently became president and chief executive officer of Blue Cross and Blue Shield of North Carolina.
Dr. Conway is known for his ability to develop and promote alternative payment models. He was elected to the National Academy of Medicine’s Institute of Medicine in 2014 and was selected as a Master of Hospital Medicine by the Society of Hospital Medicine.
Lynn Massingale, MD, the cofounder and chairman of TeamHealth, was named one of the 50 Most Influential Physician Executives and Leaders for a third year running, coming in at number 27 on the list. Dr. Massingale, who also recently was named to the Tennessee Healthcare Hall of Fame, founded TeamHealth in 1979 and was its chief executive officer for 30 years before assuming the role of chairman in 2008.
TeamHealth provides outsourced emergency medicine, hospitalist, critical care, anesthesiology, and acute care surgery services, among other specialties, at more than 3,200 facilities and physician groups across the United States.
Veeravat Taecharvongphairoj, MD, a veteran internist and hospitalist at Hemet Valley Medical Center in Hemet, Calif., has been honored by the International Association of Healthcare Professionals in its Leading Physicians of the World publication.
Dr. Taecharvongphairoj completed his residency at the University of Hawaii, Honolulu, before accepting a fellowship in hospital and palliative care at Cedars-Sinai Medical Center, Los Angeles. He is a member of the American Academy of Hospice and Palliative Medicine.
Sean Bain, MD, has been selected to the Glen Falls (N.Y.) Hospital Foundation Board of Trustees for 2018. Dr. Bain works as a hospitalist/internist at Glen Falls Hospital, where he is the president of medical staff. He manages the credentialing, continuing education, and policies and practices for the staff’s providers.
Dr. Bain received his medical degree at Albany (N.Y.) Medical College and served his residency at Wake Forest Baptist Medical Center, Winston-Salem, N.C.
George Harrison, MD, has been tabbed the new chief medical officer at Fairview Park Hospital in Dublin, Ga. Dr. Harrison will be charged with managing clinical quality and patient safety, staff relations, and clinical integration strategies at the hospital.
Prior to his appointment, Dr. Harrison was the codirector of the hospitalist program at Fairview Park. The Georgia native previously worked in management roles at urgent care centers, family practice centers, and hospitalist programs in North Carolina, South Carolina, and Georgia. He is a member of the American Academy of Family Physicians, the Society of Hospital Medicine, and the American Academy of Physician Leaders.
Dr. Harrison taught high school geometry and chemistry before earning his medical degree at the Morehouse School of Medicine, Atlanta. He did his residency at Duke University Medical Center, Durham, N.C.
BUSINESS MOVES
U.S. Acute Care Solutions (Canton, Ohio), a physician-owned, national provider of emergency medicine and hospitalist services, has extended its relationship with Central Health of Colorado and western Kansas. USACS has acquired the physicians of Front Range Emergency Specialists (Colorado Springs, Colo.), Southwest Emergency Physicians (Durango, Colo.), and Southern Colorado Emergency Specialists (Pueblo, Colo.).
USACS’s acquisition of these three physician groups adds care to more than 175,000 patients each year in central and southwest Colorado. USACS cares for more than 6 million patients per year at more than 200 locations across the United States.
VEP Healthcare (Concord, Calif.), an emergency medicine and hospitalist staffing company, has signed on to manage hospitalist and ED services at City Hospital at White Rock in Dallas. Its goals are to increase patient satisfaction, decrease wait times in seeing providers, raise recommendation rates, and lower malpractice claims.
White Rock is a 218-bed, community hospital providing care to East Texas since 1959.
Modern Healthcare recently announced its list of the 50 Most Influential Physician Executives and Leaders, and hospital medicine was well represented among the honorees. The honored physicians were selected by a panel of experts and peers for their leadership and impact on the profession.
Topping the list was Scott Gottlieb, MD, the commissioner of the Food and Drug Administration. Dr. Gottlieb was confirmed to his position in May 2017 and, in his first year, has focused on price transparency and the approval of generic medications.
Dr. Gottlieb was deputy commissioner of the FDA from 2005-2007, and he has worked as an advisor and analyst for GlaxoSmithKline, the American Enterprise Institute, Vertex Pharmaceuticals, and Avilene Health.
Dr. Gottlieb earned his medical degree from the Icahn School of Medicine at Mount Sinai, New York, and completed his residency at Mount Sinai Hospital. He has worked as a hospitalist at New York University’s Tisch Hospital, the Hospital for Joint Diseases, and Stamford (Conn.) Hospital.
Patrick Conway, MD, was listed at number 23 on Modern Healthcare’s 50 Most Influential Physician Executives and Leaders. Formerly the deputy administrator for innovation and quality at the Centers for Medicare & Medicaid Services, Dr. Conway recently became president and chief executive officer of Blue Cross and Blue Shield of North Carolina.
Dr. Conway is known for his ability to develop and promote alternative payment models. He was elected to the National Academy of Medicine’s Institute of Medicine in 2014 and was selected as a Master of Hospital Medicine by the Society of Hospital Medicine.
Lynn Massingale, MD, the cofounder and chairman of TeamHealth, was named one of the 50 Most Influential Physician Executives and Leaders for a third year running, coming in at number 27 on the list. Dr. Massingale, who also recently was named to the Tennessee Healthcare Hall of Fame, founded TeamHealth in 1979 and was its chief executive officer for 30 years before assuming the role of chairman in 2008.
TeamHealth provides outsourced emergency medicine, hospitalist, critical care, anesthesiology, and acute care surgery services, among other specialties, at more than 3,200 facilities and physician groups across the United States.
Veeravat Taecharvongphairoj, MD, a veteran internist and hospitalist at Hemet Valley Medical Center in Hemet, Calif., has been honored by the International Association of Healthcare Professionals in its Leading Physicians of the World publication.
Dr. Taecharvongphairoj completed his residency at the University of Hawaii, Honolulu, before accepting a fellowship in hospital and palliative care at Cedars-Sinai Medical Center, Los Angeles. He is a member of the American Academy of Hospice and Palliative Medicine.
Sean Bain, MD, has been selected to the Glen Falls (N.Y.) Hospital Foundation Board of Trustees for 2018. Dr. Bain works as a hospitalist/internist at Glen Falls Hospital, where he is the president of medical staff. He manages the credentialing, continuing education, and policies and practices for the staff’s providers.
Dr. Bain received his medical degree at Albany (N.Y.) Medical College and served his residency at Wake Forest Baptist Medical Center, Winston-Salem, N.C.
George Harrison, MD, has been tabbed the new chief medical officer at Fairview Park Hospital in Dublin, Ga. Dr. Harrison will be charged with managing clinical quality and patient safety, staff relations, and clinical integration strategies at the hospital.
Prior to his appointment, Dr. Harrison was the codirector of the hospitalist program at Fairview Park. The Georgia native previously worked in management roles at urgent care centers, family practice centers, and hospitalist programs in North Carolina, South Carolina, and Georgia. He is a member of the American Academy of Family Physicians, the Society of Hospital Medicine, and the American Academy of Physician Leaders.
Dr. Harrison taught high school geometry and chemistry before earning his medical degree at the Morehouse School of Medicine, Atlanta. He did his residency at Duke University Medical Center, Durham, N.C.
BUSINESS MOVES
U.S. Acute Care Solutions (Canton, Ohio), a physician-owned, national provider of emergency medicine and hospitalist services, has extended its relationship with Central Health of Colorado and western Kansas. USACS has acquired the physicians of Front Range Emergency Specialists (Colorado Springs, Colo.), Southwest Emergency Physicians (Durango, Colo.), and Southern Colorado Emergency Specialists (Pueblo, Colo.).
USACS’s acquisition of these three physician groups adds care to more than 175,000 patients each year in central and southwest Colorado. USACS cares for more than 6 million patients per year at more than 200 locations across the United States.
VEP Healthcare (Concord, Calif.), an emergency medicine and hospitalist staffing company, has signed on to manage hospitalist and ED services at City Hospital at White Rock in Dallas. Its goals are to increase patient satisfaction, decrease wait times in seeing providers, raise recommendation rates, and lower malpractice claims.
White Rock is a 218-bed, community hospital providing care to East Texas since 1959.
Modern Healthcare recently announced its list of the 50 Most Influential Physician Executives and Leaders, and hospital medicine was well represented among the honorees. The honored physicians were selected by a panel of experts and peers for their leadership and impact on the profession.
Topping the list was Scott Gottlieb, MD, the commissioner of the Food and Drug Administration. Dr. Gottlieb was confirmed to his position in May 2017 and, in his first year, has focused on price transparency and the approval of generic medications.
Dr. Gottlieb was deputy commissioner of the FDA from 2005-2007, and he has worked as an advisor and analyst for GlaxoSmithKline, the American Enterprise Institute, Vertex Pharmaceuticals, and Avilene Health.
Dr. Gottlieb earned his medical degree from the Icahn School of Medicine at Mount Sinai, New York, and completed his residency at Mount Sinai Hospital. He has worked as a hospitalist at New York University’s Tisch Hospital, the Hospital for Joint Diseases, and Stamford (Conn.) Hospital.
Patrick Conway, MD, was listed at number 23 on Modern Healthcare’s 50 Most Influential Physician Executives and Leaders. Formerly the deputy administrator for innovation and quality at the Centers for Medicare & Medicaid Services, Dr. Conway recently became president and chief executive officer of Blue Cross and Blue Shield of North Carolina.
Dr. Conway is known for his ability to develop and promote alternative payment models. He was elected to the National Academy of Medicine’s Institute of Medicine in 2014 and was selected as a Master of Hospital Medicine by the Society of Hospital Medicine.
Lynn Massingale, MD, the cofounder and chairman of TeamHealth, was named one of the 50 Most Influential Physician Executives and Leaders for a third year running, coming in at number 27 on the list. Dr. Massingale, who also recently was named to the Tennessee Healthcare Hall of Fame, founded TeamHealth in 1979 and was its chief executive officer for 30 years before assuming the role of chairman in 2008.
TeamHealth provides outsourced emergency medicine, hospitalist, critical care, anesthesiology, and acute care surgery services, among other specialties, at more than 3,200 facilities and physician groups across the United States.
Veeravat Taecharvongphairoj, MD, a veteran internist and hospitalist at Hemet Valley Medical Center in Hemet, Calif., has been honored by the International Association of Healthcare Professionals in its Leading Physicians of the World publication.
Dr. Taecharvongphairoj completed his residency at the University of Hawaii, Honolulu, before accepting a fellowship in hospital and palliative care at Cedars-Sinai Medical Center, Los Angeles. He is a member of the American Academy of Hospice and Palliative Medicine.
Sean Bain, MD, has been selected to the Glen Falls (N.Y.) Hospital Foundation Board of Trustees for 2018. Dr. Bain works as a hospitalist/internist at Glen Falls Hospital, where he is the president of medical staff. He manages the credentialing, continuing education, and policies and practices for the staff’s providers.
Dr. Bain received his medical degree at Albany (N.Y.) Medical College and served his residency at Wake Forest Baptist Medical Center, Winston-Salem, N.C.
George Harrison, MD, has been tabbed the new chief medical officer at Fairview Park Hospital in Dublin, Ga. Dr. Harrison will be charged with managing clinical quality and patient safety, staff relations, and clinical integration strategies at the hospital.
Prior to his appointment, Dr. Harrison was the codirector of the hospitalist program at Fairview Park. The Georgia native previously worked in management roles at urgent care centers, family practice centers, and hospitalist programs in North Carolina, South Carolina, and Georgia. He is a member of the American Academy of Family Physicians, the Society of Hospital Medicine, and the American Academy of Physician Leaders.
Dr. Harrison taught high school geometry and chemistry before earning his medical degree at the Morehouse School of Medicine, Atlanta. He did his residency at Duke University Medical Center, Durham, N.C.
BUSINESS MOVES
U.S. Acute Care Solutions (Canton, Ohio), a physician-owned, national provider of emergency medicine and hospitalist services, has extended its relationship with Central Health of Colorado and western Kansas. USACS has acquired the physicians of Front Range Emergency Specialists (Colorado Springs, Colo.), Southwest Emergency Physicians (Durango, Colo.), and Southern Colorado Emergency Specialists (Pueblo, Colo.).
USACS’s acquisition of these three physician groups adds care to more than 175,000 patients each year in central and southwest Colorado. USACS cares for more than 6 million patients per year at more than 200 locations across the United States.
VEP Healthcare (Concord, Calif.), an emergency medicine and hospitalist staffing company, has signed on to manage hospitalist and ED services at City Hospital at White Rock in Dallas. Its goals are to increase patient satisfaction, decrease wait times in seeing providers, raise recommendation rates, and lower malpractice claims.
White Rock is a 218-bed, community hospital providing care to East Texas since 1959.
Half as many people are trying heroin, but marijuana use grows
Some good news from the front lines of the heroin crisis: Half as many people tried heroin for the first time in 2017 as in 2016. That’s according to data released Sept. 14 from the government’s annual National Survey on Drug Use and Health.
“This is what we were hoping for,” said Elinore McCance-Katz, MD, who directs the Substance Abuse and Mental Health Services Administration. “It tells us that we are getting the word out to the American people of the risks of heroin,” especially when the drug is tainted with additional powerful opioids, fentanyl or carfentanil.
The survey found that marijuana use, however, increased in 2017, especially among pregnant women and young adults. Dr. McCance-Katz said the increase was likely linked to the growing number of states that have legalized marijuana and the misperception that marijuana is harmless.
Dr. McCance-Katz attributed the drop in new heroin users to increased government funding for prevention and public messaging on the local, state and federal levels.
David Kan, MD, president of the California Society of Addiction Medicine, was surprised by the heroin finding. “This report seems to run counter to the common wisdom that everyone is migrating from prescription medications to heroin,” he said. Still, the number of drug overdose deaths continued to climb to a staggering 72,000 in 2017, with the sharpest increase among people who used fentanyl or other synthetic opioids. “All it takes is one exposure to fentanyl to die,” Dr. Kan said.
The survey also found a small increase in the number of people with substance use disorders who receive specialty treatment, particularly heroin and opioid users. Nonetheless, 92% of people with substance use disorders do not receive it.
“It’s unacceptable,” said Greg Williams, executive vice president of Facing Addiction, a nonprofit group that advocates for people struggling with substance use disorders. “We’ve had a 90% treatment gap in America for the two decades we’ve been tracking it, and we have not been able to close it.” Despite all the news coverage of the drug crisis, he said, “the response has been woefully inadequate.”
As for marijuana, it appears that public health messaging has not been as effective as marketing efforts by the burgeoning cannabis industry. “When you have an industry that does nothing but blanket our society with messages about the medicinal value of marijuana, people get the idea this is a safe substance to use. And that’s not true,” said Dr. McCance-Katz.
Cannabis does appear to have medical benefits – in June, for example, the FDA approved the first cannabinoid-derived medication for the treatment of epilepsy. But Dr. McCance-Katz said there is already ample evidence that the drug can pose serious health risks, particularly for teenagers, young adults and pregnant women.
The survey found that during 2015-2017, the percentage of pregnant women who reported marijuana use more than doubled, to 7.1%. Often, they use it to combat nausea and pain, believing it is safer than the drugs prescribed by their doctors and approved of by the Food and Drug Administration. Mounting evidence, however, suggests that marijuana can cause preterm birth and long-term neurologic problems in the babies of mothers who use it during pregnancy.
“I’m going to talk about it every chance I get,” said Dr. McCance-Katz. “Americans have the right to know that marijuana has risks.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Some good news from the front lines of the heroin crisis: Half as many people tried heroin for the first time in 2017 as in 2016. That’s according to data released Sept. 14 from the government’s annual National Survey on Drug Use and Health.
“This is what we were hoping for,” said Elinore McCance-Katz, MD, who directs the Substance Abuse and Mental Health Services Administration. “It tells us that we are getting the word out to the American people of the risks of heroin,” especially when the drug is tainted with additional powerful opioids, fentanyl or carfentanil.
The survey found that marijuana use, however, increased in 2017, especially among pregnant women and young adults. Dr. McCance-Katz said the increase was likely linked to the growing number of states that have legalized marijuana and the misperception that marijuana is harmless.
Dr. McCance-Katz attributed the drop in new heroin users to increased government funding for prevention and public messaging on the local, state and federal levels.
David Kan, MD, president of the California Society of Addiction Medicine, was surprised by the heroin finding. “This report seems to run counter to the common wisdom that everyone is migrating from prescription medications to heroin,” he said. Still, the number of drug overdose deaths continued to climb to a staggering 72,000 in 2017, with the sharpest increase among people who used fentanyl or other synthetic opioids. “All it takes is one exposure to fentanyl to die,” Dr. Kan said.
The survey also found a small increase in the number of people with substance use disorders who receive specialty treatment, particularly heroin and opioid users. Nonetheless, 92% of people with substance use disorders do not receive it.
“It’s unacceptable,” said Greg Williams, executive vice president of Facing Addiction, a nonprofit group that advocates for people struggling with substance use disorders. “We’ve had a 90% treatment gap in America for the two decades we’ve been tracking it, and we have not been able to close it.” Despite all the news coverage of the drug crisis, he said, “the response has been woefully inadequate.”
As for marijuana, it appears that public health messaging has not been as effective as marketing efforts by the burgeoning cannabis industry. “When you have an industry that does nothing but blanket our society with messages about the medicinal value of marijuana, people get the idea this is a safe substance to use. And that’s not true,” said Dr. McCance-Katz.
Cannabis does appear to have medical benefits – in June, for example, the FDA approved the first cannabinoid-derived medication for the treatment of epilepsy. But Dr. McCance-Katz said there is already ample evidence that the drug can pose serious health risks, particularly for teenagers, young adults and pregnant women.
The survey found that during 2015-2017, the percentage of pregnant women who reported marijuana use more than doubled, to 7.1%. Often, they use it to combat nausea and pain, believing it is safer than the drugs prescribed by their doctors and approved of by the Food and Drug Administration. Mounting evidence, however, suggests that marijuana can cause preterm birth and long-term neurologic problems in the babies of mothers who use it during pregnancy.
“I’m going to talk about it every chance I get,” said Dr. McCance-Katz. “Americans have the right to know that marijuana has risks.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Some good news from the front lines of the heroin crisis: Half as many people tried heroin for the first time in 2017 as in 2016. That’s according to data released Sept. 14 from the government’s annual National Survey on Drug Use and Health.
“This is what we were hoping for,” said Elinore McCance-Katz, MD, who directs the Substance Abuse and Mental Health Services Administration. “It tells us that we are getting the word out to the American people of the risks of heroin,” especially when the drug is tainted with additional powerful opioids, fentanyl or carfentanil.
The survey found that marijuana use, however, increased in 2017, especially among pregnant women and young adults. Dr. McCance-Katz said the increase was likely linked to the growing number of states that have legalized marijuana and the misperception that marijuana is harmless.
Dr. McCance-Katz attributed the drop in new heroin users to increased government funding for prevention and public messaging on the local, state and federal levels.
David Kan, MD, president of the California Society of Addiction Medicine, was surprised by the heroin finding. “This report seems to run counter to the common wisdom that everyone is migrating from prescription medications to heroin,” he said. Still, the number of drug overdose deaths continued to climb to a staggering 72,000 in 2017, with the sharpest increase among people who used fentanyl or other synthetic opioids. “All it takes is one exposure to fentanyl to die,” Dr. Kan said.
The survey also found a small increase in the number of people with substance use disorders who receive specialty treatment, particularly heroin and opioid users. Nonetheless, 92% of people with substance use disorders do not receive it.
“It’s unacceptable,” said Greg Williams, executive vice president of Facing Addiction, a nonprofit group that advocates for people struggling with substance use disorders. “We’ve had a 90% treatment gap in America for the two decades we’ve been tracking it, and we have not been able to close it.” Despite all the news coverage of the drug crisis, he said, “the response has been woefully inadequate.”
As for marijuana, it appears that public health messaging has not been as effective as marketing efforts by the burgeoning cannabis industry. “When you have an industry that does nothing but blanket our society with messages about the medicinal value of marijuana, people get the idea this is a safe substance to use. And that’s not true,” said Dr. McCance-Katz.
Cannabis does appear to have medical benefits – in June, for example, the FDA approved the first cannabinoid-derived medication for the treatment of epilepsy. But Dr. McCance-Katz said there is already ample evidence that the drug can pose serious health risks, particularly for teenagers, young adults and pregnant women.
The survey found that during 2015-2017, the percentage of pregnant women who reported marijuana use more than doubled, to 7.1%. Often, they use it to combat nausea and pain, believing it is safer than the drugs prescribed by their doctors and approved of by the Food and Drug Administration. Mounting evidence, however, suggests that marijuana can cause preterm birth and long-term neurologic problems in the babies of mothers who use it during pregnancy.
“I’m going to talk about it every chance I get,” said Dr. McCance-Katz. “Americans have the right to know that marijuana has risks.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Inpatient vs. outpatient addiction treatment: Which is best?
In the course of my general psychiatry practice, there are times when I am unable to manage a patient’s substance abuse issues, and I have referred patients to a higher level of care – often to an intensive outpatient program (IOP) that meets for 3 hours a day, or to an inpatient rehabilitation, usually for 28 days. I’m not always sure who can be managed in which setting, and I usually honor the patient’s wishes. If the patient is motivated, has a support system in place, and is concerned that his job will be in jeopardy if he takes time off work, then I refer to Kolmac Outpatient Recovery Centers, a local outpatient treatment center that gives patients the option of attending in the mornings or evenings and allows most people to continue working. If I think I may have only a single shot at getting a patient engaged in care, and the patient is willing to go to an inpatient setting, I refer to a residential treatment facility. It has occurred to me that this is not a very scientific way of making a treatment decision.
George Kolodner, MD, is the chief clinical officer of Kolmac. He has been a member of the American Society of Addiction Medicine’s (ASAM) treatment criteria committee. When I spoke with Dr. Kolodner, he noted: “Discussions between third-party payers and treatment programs about what is the appropriate level of care for a particular individual have been adversarial. ASAM has spent many years developing the ASAM Criteria, a document that attempts to mediate these disagreements by developing objective criteria for where people ought to be treated. Because it is so comprehensive and the variables are so many, it can be difficult to use. A computerized version, called ‘Continuum,’ has been developed to make the criteria more user-friendly.”
“My 45-year experience,” Dr. Kolodner continued, “is that detoxification and rehabilitation can usually be done successfully on an outpatient basis if an appropriate facility is available and the patient has both a supportive living environment and can get to the treatment. Hospitalization and residential rehabilitation is an essential level of care when those conditions do not exist or when outpatient treatment proves to be insufficient.”
One problem with comparing the success of IOPs to inpatient programs is that these settings differ widely in which services they offer to patients.
“There’s no standardization,” Dr. Kolodner said. “The services may be watered down, they may not have a medical staff or a psychiatrist, and people get sucked into inappropriate treatments. When it comes to both IOPs and inpatient facilities, there is no uniformity, and right now it’s caveat emptor.”
Marc Fishman, MD, is medical director of Maryland Treatment Centers/Mountain Manor Treatment Center, a coeditor of the ASAM Criteria, and, with Dr. Kolodner, a member of ASAM’s treatment criteria committee. He, too, talked about the absence of standardization across treatment settings.
“Bed-based and non–bed-based care exist in many flavors and subflavors. You have to remember,” Dr. Fishman said, “this is a marathon, not a sprint, and one of the most important goals of bed-based care is that it serves as a stepping stone for outpatient treatment.”
Dr. Fishman talked about a list of criteria he uses to decide whether someone can be treated as an outpatient. “First, someone has to be able to access outpatient treatment; it may not be available. Can they get back and forth? How chaotic are their lives? Is there support at home, or is it a toxic environment in which others are using? Are they likely to keep using and drop out? What is the patient’s level of motivation? If a person is very ambivalent, you may need a high-intensity motivational milieu. Are their psychiatric symptoms severe enough to require 24-hour monitoring and supervision? Most detoxification we can do on an outpatient basis, but some complex multisubstance withdrawal may need more monitoring.
“Also, we have an increasing armamentarium of medications to promote abstinence, and sometimes it makes sense to start them in higher-level treatment settings; for example long-acting injectable naltrexone (Vivitrol) needs a 10-day postdetox opioid-free washout before it can be started.”
Dr. Fishman was careful to note that imminent danger is usually not a reason to use an inpatient rehab setting. “When you’re talking about safety issues, then people usually need a hospital. Most rehabs are not equipped to deal with dangerous patients.”
In choosing from the different treatment options, the first question should be to ask which forms of treatment are available with high-quality care. Can the patient access an outpatient center, will he be able to get to treatment, and will he be able to remain sober between visits? Will he be offered a full range of treatment options in that setting? Can substance withdrawal be managed safely? If the patient fails at outpatient care, will he be willing to consider inpatient treatment as a next step? What is the risk associated with relapse in a setting that allows for access to substances between sessions? Is the patient someone who is at high risk for a fatal overdose, or at high risk for endangering others, for example, someone who has been revived from overdoses or has driven while inebriated? Would this patient benefit from more intensive psychotherapeutic care? And the question that always haunts me: If there is a bad outcome, will I regret that I did not recommend more?”
Often, I’m left with the idea that it would be nice if we were all given crystal balls at the end of training. In hindsight, if a patient does well, the treatment that was offered was enough, and perhaps even too much in terms of cost. If a patient does not do well, we may be left to ask if he would have been better off if we had recommended a higher level of care, assuming that care could be financed and accessed, and that the patient complied with the treatment recommendations.
Both experts agree that treatment is often effective, and the news here is good. But treatment only works if a patient actually follows through on it, so the best treatment is often the one the patient is willing to accept.
Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).
In the course of my general psychiatry practice, there are times when I am unable to manage a patient’s substance abuse issues, and I have referred patients to a higher level of care – often to an intensive outpatient program (IOP) that meets for 3 hours a day, or to an inpatient rehabilitation, usually for 28 days. I’m not always sure who can be managed in which setting, and I usually honor the patient’s wishes. If the patient is motivated, has a support system in place, and is concerned that his job will be in jeopardy if he takes time off work, then I refer to Kolmac Outpatient Recovery Centers, a local outpatient treatment center that gives patients the option of attending in the mornings or evenings and allows most people to continue working. If I think I may have only a single shot at getting a patient engaged in care, and the patient is willing to go to an inpatient setting, I refer to a residential treatment facility. It has occurred to me that this is not a very scientific way of making a treatment decision.
George Kolodner, MD, is the chief clinical officer of Kolmac. He has been a member of the American Society of Addiction Medicine’s (ASAM) treatment criteria committee. When I spoke with Dr. Kolodner, he noted: “Discussions between third-party payers and treatment programs about what is the appropriate level of care for a particular individual have been adversarial. ASAM has spent many years developing the ASAM Criteria, a document that attempts to mediate these disagreements by developing objective criteria for where people ought to be treated. Because it is so comprehensive and the variables are so many, it can be difficult to use. A computerized version, called ‘Continuum,’ has been developed to make the criteria more user-friendly.”
“My 45-year experience,” Dr. Kolodner continued, “is that detoxification and rehabilitation can usually be done successfully on an outpatient basis if an appropriate facility is available and the patient has both a supportive living environment and can get to the treatment. Hospitalization and residential rehabilitation is an essential level of care when those conditions do not exist or when outpatient treatment proves to be insufficient.”
One problem with comparing the success of IOPs to inpatient programs is that these settings differ widely in which services they offer to patients.
“There’s no standardization,” Dr. Kolodner said. “The services may be watered down, they may not have a medical staff or a psychiatrist, and people get sucked into inappropriate treatments. When it comes to both IOPs and inpatient facilities, there is no uniformity, and right now it’s caveat emptor.”
Marc Fishman, MD, is medical director of Maryland Treatment Centers/Mountain Manor Treatment Center, a coeditor of the ASAM Criteria, and, with Dr. Kolodner, a member of ASAM’s treatment criteria committee. He, too, talked about the absence of standardization across treatment settings.
“Bed-based and non–bed-based care exist in many flavors and subflavors. You have to remember,” Dr. Fishman said, “this is a marathon, not a sprint, and one of the most important goals of bed-based care is that it serves as a stepping stone for outpatient treatment.”
Dr. Fishman talked about a list of criteria he uses to decide whether someone can be treated as an outpatient. “First, someone has to be able to access outpatient treatment; it may not be available. Can they get back and forth? How chaotic are their lives? Is there support at home, or is it a toxic environment in which others are using? Are they likely to keep using and drop out? What is the patient’s level of motivation? If a person is very ambivalent, you may need a high-intensity motivational milieu. Are their psychiatric symptoms severe enough to require 24-hour monitoring and supervision? Most detoxification we can do on an outpatient basis, but some complex multisubstance withdrawal may need more monitoring.
“Also, we have an increasing armamentarium of medications to promote abstinence, and sometimes it makes sense to start them in higher-level treatment settings; for example long-acting injectable naltrexone (Vivitrol) needs a 10-day postdetox opioid-free washout before it can be started.”
Dr. Fishman was careful to note that imminent danger is usually not a reason to use an inpatient rehab setting. “When you’re talking about safety issues, then people usually need a hospital. Most rehabs are not equipped to deal with dangerous patients.”
In choosing from the different treatment options, the first question should be to ask which forms of treatment are available with high-quality care. Can the patient access an outpatient center, will he be able to get to treatment, and will he be able to remain sober between visits? Will he be offered a full range of treatment options in that setting? Can substance withdrawal be managed safely? If the patient fails at outpatient care, will he be willing to consider inpatient treatment as a next step? What is the risk associated with relapse in a setting that allows for access to substances between sessions? Is the patient someone who is at high risk for a fatal overdose, or at high risk for endangering others, for example, someone who has been revived from overdoses or has driven while inebriated? Would this patient benefit from more intensive psychotherapeutic care? And the question that always haunts me: If there is a bad outcome, will I regret that I did not recommend more?”
Often, I’m left with the idea that it would be nice if we were all given crystal balls at the end of training. In hindsight, if a patient does well, the treatment that was offered was enough, and perhaps even too much in terms of cost. If a patient does not do well, we may be left to ask if he would have been better off if we had recommended a higher level of care, assuming that care could be financed and accessed, and that the patient complied with the treatment recommendations.
Both experts agree that treatment is often effective, and the news here is good. But treatment only works if a patient actually follows through on it, so the best treatment is often the one the patient is willing to accept.
Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).
In the course of my general psychiatry practice, there are times when I am unable to manage a patient’s substance abuse issues, and I have referred patients to a higher level of care – often to an intensive outpatient program (IOP) that meets for 3 hours a day, or to an inpatient rehabilitation, usually for 28 days. I’m not always sure who can be managed in which setting, and I usually honor the patient’s wishes. If the patient is motivated, has a support system in place, and is concerned that his job will be in jeopardy if he takes time off work, then I refer to Kolmac Outpatient Recovery Centers, a local outpatient treatment center that gives patients the option of attending in the mornings or evenings and allows most people to continue working. If I think I may have only a single shot at getting a patient engaged in care, and the patient is willing to go to an inpatient setting, I refer to a residential treatment facility. It has occurred to me that this is not a very scientific way of making a treatment decision.
George Kolodner, MD, is the chief clinical officer of Kolmac. He has been a member of the American Society of Addiction Medicine’s (ASAM) treatment criteria committee. When I spoke with Dr. Kolodner, he noted: “Discussions between third-party payers and treatment programs about what is the appropriate level of care for a particular individual have been adversarial. ASAM has spent many years developing the ASAM Criteria, a document that attempts to mediate these disagreements by developing objective criteria for where people ought to be treated. Because it is so comprehensive and the variables are so many, it can be difficult to use. A computerized version, called ‘Continuum,’ has been developed to make the criteria more user-friendly.”
“My 45-year experience,” Dr. Kolodner continued, “is that detoxification and rehabilitation can usually be done successfully on an outpatient basis if an appropriate facility is available and the patient has both a supportive living environment and can get to the treatment. Hospitalization and residential rehabilitation is an essential level of care when those conditions do not exist or when outpatient treatment proves to be insufficient.”
One problem with comparing the success of IOPs to inpatient programs is that these settings differ widely in which services they offer to patients.
“There’s no standardization,” Dr. Kolodner said. “The services may be watered down, they may not have a medical staff or a psychiatrist, and people get sucked into inappropriate treatments. When it comes to both IOPs and inpatient facilities, there is no uniformity, and right now it’s caveat emptor.”
Marc Fishman, MD, is medical director of Maryland Treatment Centers/Mountain Manor Treatment Center, a coeditor of the ASAM Criteria, and, with Dr. Kolodner, a member of ASAM’s treatment criteria committee. He, too, talked about the absence of standardization across treatment settings.
“Bed-based and non–bed-based care exist in many flavors and subflavors. You have to remember,” Dr. Fishman said, “this is a marathon, not a sprint, and one of the most important goals of bed-based care is that it serves as a stepping stone for outpatient treatment.”
Dr. Fishman talked about a list of criteria he uses to decide whether someone can be treated as an outpatient. “First, someone has to be able to access outpatient treatment; it may not be available. Can they get back and forth? How chaotic are their lives? Is there support at home, or is it a toxic environment in which others are using? Are they likely to keep using and drop out? What is the patient’s level of motivation? If a person is very ambivalent, you may need a high-intensity motivational milieu. Are their psychiatric symptoms severe enough to require 24-hour monitoring and supervision? Most detoxification we can do on an outpatient basis, but some complex multisubstance withdrawal may need more monitoring.
“Also, we have an increasing armamentarium of medications to promote abstinence, and sometimes it makes sense to start them in higher-level treatment settings; for example long-acting injectable naltrexone (Vivitrol) needs a 10-day postdetox opioid-free washout before it can be started.”
Dr. Fishman was careful to note that imminent danger is usually not a reason to use an inpatient rehab setting. “When you’re talking about safety issues, then people usually need a hospital. Most rehabs are not equipped to deal with dangerous patients.”
In choosing from the different treatment options, the first question should be to ask which forms of treatment are available with high-quality care. Can the patient access an outpatient center, will he be able to get to treatment, and will he be able to remain sober between visits? Will he be offered a full range of treatment options in that setting? Can substance withdrawal be managed safely? If the patient fails at outpatient care, will he be willing to consider inpatient treatment as a next step? What is the risk associated with relapse in a setting that allows for access to substances between sessions? Is the patient someone who is at high risk for a fatal overdose, or at high risk for endangering others, for example, someone who has been revived from overdoses or has driven while inebriated? Would this patient benefit from more intensive psychotherapeutic care? And the question that always haunts me: If there is a bad outcome, will I regret that I did not recommend more?”
Often, I’m left with the idea that it would be nice if we were all given crystal balls at the end of training. In hindsight, if a patient does well, the treatment that was offered was enough, and perhaps even too much in terms of cost. If a patient does not do well, we may be left to ask if he would have been better off if we had recommended a higher level of care, assuming that care could be financed and accessed, and that the patient complied with the treatment recommendations.
Both experts agree that treatment is often effective, and the news here is good. But treatment only works if a patient actually follows through on it, so the best treatment is often the one the patient is willing to accept.
Dr. Miller is the coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).