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Patients With MS Who Consider Marijuana Use More Likely to Engage in Risky Behaviors
Key clinical point: Patients with multiple sclerosis who consider marijuana use are more likely to smoke and drink alcohol.
Major finding: Among multiple sclerosis patients who responded to a survey, 25.4% had used marijuana for their multiple sclerosis, 20.0% had discussed it with their doctors, and 16.1% were currently using some form of marijuana.
Study details: Questionnaire responses about health behaviors from 5,481 active participants in the North American Research Committee on Multiple Sclerosis.
Disclosures: The North American Research Committee on Multiple Sclerosis is funded in part by the Consortium of Multiple Sclerosis Centers and the Foundation of the CMSC. The present study had no funding support. Dr. Cofield reported receiving a consulting fee from the U.S. Department of Defense.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Patients with multiple sclerosis who consider marijuana use are more likely to smoke and drink alcohol.
Major finding: Among multiple sclerosis patients who responded to a survey, 25.4% had used marijuana for their multiple sclerosis, 20.0% had discussed it with their doctors, and 16.1% were currently using some form of marijuana.
Study details: Questionnaire responses about health behaviors from 5,481 active participants in the North American Research Committee on Multiple Sclerosis.
Disclosures: The North American Research Committee on Multiple Sclerosis is funded in part by the Consortium of Multiple Sclerosis Centers and the Foundation of the CMSC. The present study had no funding support. Dr. Cofield reported receiving a consulting fee from the U.S. Department of Defense.
Citation: REPORTING FROM CMSC 2019
Key clinical point: Patients with multiple sclerosis who consider marijuana use are more likely to smoke and drink alcohol.
Major finding: Among multiple sclerosis patients who responded to a survey, 25.4% had used marijuana for their multiple sclerosis, 20.0% had discussed it with their doctors, and 16.1% were currently using some form of marijuana.
Study details: Questionnaire responses about health behaviors from 5,481 active participants in the North American Research Committee on Multiple Sclerosis.
Disclosures: The North American Research Committee on Multiple Sclerosis is funded in part by the Consortium of Multiple Sclerosis Centers and the Foundation of the CMSC. The present study had no funding support. Dr. Cofield reported receiving a consulting fee from the U.S. Department of Defense.
Citation: REPORTING FROM CMSC 2019
Pediatric-Onset MS May Slow Information Processing in Adulthood
Key clinical point: Patients with pediatric-onset multiple sclerosis (MS) are more likely than those with adult-onset MS to have cognitive impairment in adulthood.
Major finding: At age 35 years, the mean Symbol Digit Modalities Test score for patients with adult-onset MS was 61, whereas for patients with pediatric-onset MS it was 51. By age 40 years, the mean score was 58 for adult-onset MS versus 46 for pediatric-onset MS.
Study details: A Swedish population-based, longitudinal cohort study of 5,704 patients with MS, 300 of whom had pediatric-onset MS (5%).
Disclosures: The study was supported by the Swedish Research Council, the Swedish Brain Foundation, and by postdoctoral awards from the Canadian Institutes of Health Research and European Committee for Treatment and Research in Multiple Sclerosis, both to Dr. McKay. Coauthors reported receiving honoraria for speaking and serving on advisory boards for various pharmaceutical companies, as well as receiving research funding from agencies, foundations, and pharmaceutical companies.
Citation: McKay KA et al. JAMA Neurol. 2019 Jun 17. doi: 10.1001/jamaneurol.2019.1546.
Key clinical point: Patients with pediatric-onset multiple sclerosis (MS) are more likely than those with adult-onset MS to have cognitive impairment in adulthood.
Major finding: At age 35 years, the mean Symbol Digit Modalities Test score for patients with adult-onset MS was 61, whereas for patients with pediatric-onset MS it was 51. By age 40 years, the mean score was 58 for adult-onset MS versus 46 for pediatric-onset MS.
Study details: A Swedish population-based, longitudinal cohort study of 5,704 patients with MS, 300 of whom had pediatric-onset MS (5%).
Disclosures: The study was supported by the Swedish Research Council, the Swedish Brain Foundation, and by postdoctoral awards from the Canadian Institutes of Health Research and European Committee for Treatment and Research in Multiple Sclerosis, both to Dr. McKay. Coauthors reported receiving honoraria for speaking and serving on advisory boards for various pharmaceutical companies, as well as receiving research funding from agencies, foundations, and pharmaceutical companies.
Citation: McKay KA et al. JAMA Neurol. 2019 Jun 17. doi: 10.1001/jamaneurol.2019.1546.
Key clinical point: Patients with pediatric-onset multiple sclerosis (MS) are more likely than those with adult-onset MS to have cognitive impairment in adulthood.
Major finding: At age 35 years, the mean Symbol Digit Modalities Test score for patients with adult-onset MS was 61, whereas for patients with pediatric-onset MS it was 51. By age 40 years, the mean score was 58 for adult-onset MS versus 46 for pediatric-onset MS.
Study details: A Swedish population-based, longitudinal cohort study of 5,704 patients with MS, 300 of whom had pediatric-onset MS (5%).
Disclosures: The study was supported by the Swedish Research Council, the Swedish Brain Foundation, and by postdoctoral awards from the Canadian Institutes of Health Research and European Committee for Treatment and Research in Multiple Sclerosis, both to Dr. McKay. Coauthors reported receiving honoraria for speaking and serving on advisory boards for various pharmaceutical companies, as well as receiving research funding from agencies, foundations, and pharmaceutical companies.
Citation: McKay KA et al. JAMA Neurol. 2019 Jun 17. doi: 10.1001/jamaneurol.2019.1546.
Zoledronic acid reduces symptomatic periodontal disease in patients with osteoporosis
according to Akira Taguchi, DDS, PhD, of the department of oral and maxillofacial radiology at Matsumoto Dental University, Nagano, Japan, and associates.
In a study published in Menopause, the investigators retrospectively analyzed 542 men and women with osteoporosis who participated in the randomized ZONE (Zoledronate Treatment in Efficacy to Osteoporosis) trial. Patients received either zoledronic acid (n = 258) or placebo (n = 284) once yearly for 2 years by IV infusion; mean age was 74 years in both groups. Patients were instructed to maintain good oral health at baseline and every 3 months afterward. Participants with signs or symptoms involving the oral cavity at the follow-up approximately every 3 months were referred to dentists for examination of oral disease.
Oral adverse events were significantly more common in the placebo group, compared with the zoledronic acid group (20% vs. 14%; P = .04); incidence of symptomatic periodontal disease also was significantly more common in those receiving placebo (12% vs. 5%; P = .002). While loss of teeth was more common in the control group than in those receiving zoledronic acid (11% vs. 7%), the difference was not significant.
“Because zoledronic acid can prevent symptomatic periodontal disease when combined with good oral hygiene management, it is possible that the procedures performed in this study could eventually suppress the development of [osteonecrosis of the jaw],” the investigators concluded.
The study was funded by Asahi-Kasei Pharma. The investigators reported employment or receiving consulting fees from numerous pharmaceutical companies.
SOURCE: Taguchi A et al. Menopause. 2019 Aug 19. doi: 10.1097/GME.0000000000001393.
according to Akira Taguchi, DDS, PhD, of the department of oral and maxillofacial radiology at Matsumoto Dental University, Nagano, Japan, and associates.
In a study published in Menopause, the investigators retrospectively analyzed 542 men and women with osteoporosis who participated in the randomized ZONE (Zoledronate Treatment in Efficacy to Osteoporosis) trial. Patients received either zoledronic acid (n = 258) or placebo (n = 284) once yearly for 2 years by IV infusion; mean age was 74 years in both groups. Patients were instructed to maintain good oral health at baseline and every 3 months afterward. Participants with signs or symptoms involving the oral cavity at the follow-up approximately every 3 months were referred to dentists for examination of oral disease.
Oral adverse events were significantly more common in the placebo group, compared with the zoledronic acid group (20% vs. 14%; P = .04); incidence of symptomatic periodontal disease also was significantly more common in those receiving placebo (12% vs. 5%; P = .002). While loss of teeth was more common in the control group than in those receiving zoledronic acid (11% vs. 7%), the difference was not significant.
“Because zoledronic acid can prevent symptomatic periodontal disease when combined with good oral hygiene management, it is possible that the procedures performed in this study could eventually suppress the development of [osteonecrosis of the jaw],” the investigators concluded.
The study was funded by Asahi-Kasei Pharma. The investigators reported employment or receiving consulting fees from numerous pharmaceutical companies.
SOURCE: Taguchi A et al. Menopause. 2019 Aug 19. doi: 10.1097/GME.0000000000001393.
according to Akira Taguchi, DDS, PhD, of the department of oral and maxillofacial radiology at Matsumoto Dental University, Nagano, Japan, and associates.
In a study published in Menopause, the investigators retrospectively analyzed 542 men and women with osteoporosis who participated in the randomized ZONE (Zoledronate Treatment in Efficacy to Osteoporosis) trial. Patients received either zoledronic acid (n = 258) or placebo (n = 284) once yearly for 2 years by IV infusion; mean age was 74 years in both groups. Patients were instructed to maintain good oral health at baseline and every 3 months afterward. Participants with signs or symptoms involving the oral cavity at the follow-up approximately every 3 months were referred to dentists for examination of oral disease.
Oral adverse events were significantly more common in the placebo group, compared with the zoledronic acid group (20% vs. 14%; P = .04); incidence of symptomatic periodontal disease also was significantly more common in those receiving placebo (12% vs. 5%; P = .002). While loss of teeth was more common in the control group than in those receiving zoledronic acid (11% vs. 7%), the difference was not significant.
“Because zoledronic acid can prevent symptomatic periodontal disease when combined with good oral hygiene management, it is possible that the procedures performed in this study could eventually suppress the development of [osteonecrosis of the jaw],” the investigators concluded.
The study was funded by Asahi-Kasei Pharma. The investigators reported employment or receiving consulting fees from numerous pharmaceutical companies.
SOURCE: Taguchi A et al. Menopause. 2019 Aug 19. doi: 10.1097/GME.0000000000001393.
FROM MENOPAUSE
Cat ladies, heroic music, and Canadian cannabis
Cat ladies: They’re just like you and me
Crazy cat ladies are … not so crazy after all. Bad news for stereotypes, but good news for women who love kitties.
A research team from UCLA observed over 500 pet owners to analyze how people reacted to distress calls from their pets. The investigators also looked at possible links between pet ownership and any mental health or social difficulties.
– meaning cat owners are scientifically proven to be normal.
The study authors specifically stated, “We found no evidence to support the ‘cat lady’ stereotype: cat-owners did not differ from others on self-reported symptoms of depression, anxiety or their experiences in close relationships.” Who would’ve thought?
Music is my hero
If you’re feeling down and need a little more motivation in life, try putting in your headphones and listening to some Hans Zimmer scores. A recently published study found that “heroic” music stimulates motivating and empowering thoughts in listeners.
Researchers had participants listen to heroic and sad music samples and fill out questionnaires after listening. They found that listening to heroic music while the mind starts wandering promotes positive, constructive, and motivating thoughts.
No word yet, though, on whether any of the participants attempted to fly or save some kittens from a tree.
The arms race continues
Intrauterine devices, pacemakers, insulin pumps, gastric bands, coronary stents, car keys: What do all of these things have in common? Right now, you’re probably thinking, “Well, I know what those first five have in common, but … car keys? There’s no way.” Yes way.
Aime Dansby, a software engineer from Dallas, had the key to her Tesla 3 – not the entire key, just the RFID chip from the credit-card-sized valet key – implanted into her arm by a body modification artist named “Pineapple,” according to Car & Driver. Seems she couldn’t get a physician to perform the procedure.
To make the chip “safe” for implantation, Ms. Dansby dissolved the rest of the card with acetone and then had the chip itself encased “in a biopolymer that is safe to use in the body and under the skin,” Popular Mechanics reported.
Ms. Dansby discusses some of her reasoning in a video on YouTube: “They say you can’t, like, start your car with that. It’s not secure. It won’t work. It makes me want to do it more.” We here at LOTME understand and support that kind of thinking, but we also hope that no one ever tells her she can’t start her car by sticking her finger in an electrical socket.
O (THC)anada
It can be difficult to get a precise estimate on the level of drug use within a city or country. Perhaps not surprisingly, many people aren’t entirely forthcoming about their drug habits, legal or not. But their poop … the poop never lies.
That’s why Stats Canada, in an effort to find new ways to collect data relating to the legalization of cannabis, conducted a survey of wastewater from five Canadian cities: Halifax, Montreal, Toronto, Edmonton, and Vancouver. In other words, they looked through the poop of about 8.4 million people to find out what drugs they preferred, gathering information on cannabis, cocaine, opioids, and methamphetamine.
Despite its legal status, cannabis usage was not uniform across the country, as Halifax and Montreal wastewater had THC levels more than twice as high as the other three cities. Stats Canada noted that Nova Scotia has higher-than-average cannabis usage, but Quebec as a whole has lower-than-average usage. Apparently the people of Montreal just really like their weed.
In fact, only cocaine showed no geographic bent. Opioids were significantly less popular in Toronto and Montreal, and methamphetamine was much more common in Edmonton and Vancouver.
In the end, Stats Canada concluded that wastewater analysis was an effective way to test drug usage, though we suspect they may have come to a different conclusion had they made anyone other than a bunch of polite Canadians sample the sewage of over 8 million people.
Cat ladies: They’re just like you and me
Crazy cat ladies are … not so crazy after all. Bad news for stereotypes, but good news for women who love kitties.
A research team from UCLA observed over 500 pet owners to analyze how people reacted to distress calls from their pets. The investigators also looked at possible links between pet ownership and any mental health or social difficulties.
– meaning cat owners are scientifically proven to be normal.
The study authors specifically stated, “We found no evidence to support the ‘cat lady’ stereotype: cat-owners did not differ from others on self-reported symptoms of depression, anxiety or their experiences in close relationships.” Who would’ve thought?
Music is my hero
If you’re feeling down and need a little more motivation in life, try putting in your headphones and listening to some Hans Zimmer scores. A recently published study found that “heroic” music stimulates motivating and empowering thoughts in listeners.
Researchers had participants listen to heroic and sad music samples and fill out questionnaires after listening. They found that listening to heroic music while the mind starts wandering promotes positive, constructive, and motivating thoughts.
No word yet, though, on whether any of the participants attempted to fly or save some kittens from a tree.
The arms race continues
Intrauterine devices, pacemakers, insulin pumps, gastric bands, coronary stents, car keys: What do all of these things have in common? Right now, you’re probably thinking, “Well, I know what those first five have in common, but … car keys? There’s no way.” Yes way.
Aime Dansby, a software engineer from Dallas, had the key to her Tesla 3 – not the entire key, just the RFID chip from the credit-card-sized valet key – implanted into her arm by a body modification artist named “Pineapple,” according to Car & Driver. Seems she couldn’t get a physician to perform the procedure.
To make the chip “safe” for implantation, Ms. Dansby dissolved the rest of the card with acetone and then had the chip itself encased “in a biopolymer that is safe to use in the body and under the skin,” Popular Mechanics reported.
Ms. Dansby discusses some of her reasoning in a video on YouTube: “They say you can’t, like, start your car with that. It’s not secure. It won’t work. It makes me want to do it more.” We here at LOTME understand and support that kind of thinking, but we also hope that no one ever tells her she can’t start her car by sticking her finger in an electrical socket.
O (THC)anada
It can be difficult to get a precise estimate on the level of drug use within a city or country. Perhaps not surprisingly, many people aren’t entirely forthcoming about their drug habits, legal or not. But their poop … the poop never lies.
That’s why Stats Canada, in an effort to find new ways to collect data relating to the legalization of cannabis, conducted a survey of wastewater from five Canadian cities: Halifax, Montreal, Toronto, Edmonton, and Vancouver. In other words, they looked through the poop of about 8.4 million people to find out what drugs they preferred, gathering information on cannabis, cocaine, opioids, and methamphetamine.
Despite its legal status, cannabis usage was not uniform across the country, as Halifax and Montreal wastewater had THC levels more than twice as high as the other three cities. Stats Canada noted that Nova Scotia has higher-than-average cannabis usage, but Quebec as a whole has lower-than-average usage. Apparently the people of Montreal just really like their weed.
In fact, only cocaine showed no geographic bent. Opioids were significantly less popular in Toronto and Montreal, and methamphetamine was much more common in Edmonton and Vancouver.
In the end, Stats Canada concluded that wastewater analysis was an effective way to test drug usage, though we suspect they may have come to a different conclusion had they made anyone other than a bunch of polite Canadians sample the sewage of over 8 million people.
Cat ladies: They’re just like you and me
Crazy cat ladies are … not so crazy after all. Bad news for stereotypes, but good news for women who love kitties.
A research team from UCLA observed over 500 pet owners to analyze how people reacted to distress calls from their pets. The investigators also looked at possible links between pet ownership and any mental health or social difficulties.
– meaning cat owners are scientifically proven to be normal.
The study authors specifically stated, “We found no evidence to support the ‘cat lady’ stereotype: cat-owners did not differ from others on self-reported symptoms of depression, anxiety or their experiences in close relationships.” Who would’ve thought?
Music is my hero
If you’re feeling down and need a little more motivation in life, try putting in your headphones and listening to some Hans Zimmer scores. A recently published study found that “heroic” music stimulates motivating and empowering thoughts in listeners.
Researchers had participants listen to heroic and sad music samples and fill out questionnaires after listening. They found that listening to heroic music while the mind starts wandering promotes positive, constructive, and motivating thoughts.
No word yet, though, on whether any of the participants attempted to fly or save some kittens from a tree.
The arms race continues
Intrauterine devices, pacemakers, insulin pumps, gastric bands, coronary stents, car keys: What do all of these things have in common? Right now, you’re probably thinking, “Well, I know what those first five have in common, but … car keys? There’s no way.” Yes way.
Aime Dansby, a software engineer from Dallas, had the key to her Tesla 3 – not the entire key, just the RFID chip from the credit-card-sized valet key – implanted into her arm by a body modification artist named “Pineapple,” according to Car & Driver. Seems she couldn’t get a physician to perform the procedure.
To make the chip “safe” for implantation, Ms. Dansby dissolved the rest of the card with acetone and then had the chip itself encased “in a biopolymer that is safe to use in the body and under the skin,” Popular Mechanics reported.
Ms. Dansby discusses some of her reasoning in a video on YouTube: “They say you can’t, like, start your car with that. It’s not secure. It won’t work. It makes me want to do it more.” We here at LOTME understand and support that kind of thinking, but we also hope that no one ever tells her she can’t start her car by sticking her finger in an electrical socket.
O (THC)anada
It can be difficult to get a precise estimate on the level of drug use within a city or country. Perhaps not surprisingly, many people aren’t entirely forthcoming about their drug habits, legal or not. But their poop … the poop never lies.
That’s why Stats Canada, in an effort to find new ways to collect data relating to the legalization of cannabis, conducted a survey of wastewater from five Canadian cities: Halifax, Montreal, Toronto, Edmonton, and Vancouver. In other words, they looked through the poop of about 8.4 million people to find out what drugs they preferred, gathering information on cannabis, cocaine, opioids, and methamphetamine.
Despite its legal status, cannabis usage was not uniform across the country, as Halifax and Montreal wastewater had THC levels more than twice as high as the other three cities. Stats Canada noted that Nova Scotia has higher-than-average cannabis usage, but Quebec as a whole has lower-than-average usage. Apparently the people of Montreal just really like their weed.
In fact, only cocaine showed no geographic bent. Opioids were significantly less popular in Toronto and Montreal, and methamphetamine was much more common in Edmonton and Vancouver.
In the end, Stats Canada concluded that wastewater analysis was an effective way to test drug usage, though we suspect they may have come to a different conclusion had they made anyone other than a bunch of polite Canadians sample the sewage of over 8 million people.
Farxiga gets Fast Track status from FDA
The Food and Drug Administration has given Fast Track designation to the development of dapagliflozin (Farxiga) to delay progression of renal failure and to prevent cardiovascular and renal death in patients with chronic kidney disease with and without type 2 diabetes, according to a release from AstraZeneca.
The Fast Track designation is meant to accelerate the development and review process for the treatment of serious conditions that have unmet therapeutic needs.
Dapagliflozin, an oral daily sodium-glucose transporter 2 inhibitor, is approved both as a monotherapy and a component of combination therapy for the improvement of glycemic control in patients with type 2 diabetes, according to the release. It is given as an adjunct to diet and exercise, and has also shown additional benefits of weight loss and reduction in blood pressure.
A phase 3, randomized, placebo-controlled trial, DAPA-CVD (NCT03036150), is currently underway to evaluate the drug’s efficacy specifically in terms of renal outcomes and cardiovascular mortality in patients with chronic kidney disease, with and without type 2 diabetes. Participants receive once-daily dapagliflozin or placebo in addition to standard care.
Taking dapagliflozin carries risks of hypotension, renal impairment, hypoglycemia, and other concerns. The most common adverse reactions (5% or greater incidence) include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Full prescribing information can be found on the agency’s website.
The Food and Drug Administration has given Fast Track designation to the development of dapagliflozin (Farxiga) to delay progression of renal failure and to prevent cardiovascular and renal death in patients with chronic kidney disease with and without type 2 diabetes, according to a release from AstraZeneca.
The Fast Track designation is meant to accelerate the development and review process for the treatment of serious conditions that have unmet therapeutic needs.
Dapagliflozin, an oral daily sodium-glucose transporter 2 inhibitor, is approved both as a monotherapy and a component of combination therapy for the improvement of glycemic control in patients with type 2 diabetes, according to the release. It is given as an adjunct to diet and exercise, and has also shown additional benefits of weight loss and reduction in blood pressure.
A phase 3, randomized, placebo-controlled trial, DAPA-CVD (NCT03036150), is currently underway to evaluate the drug’s efficacy specifically in terms of renal outcomes and cardiovascular mortality in patients with chronic kidney disease, with and without type 2 diabetes. Participants receive once-daily dapagliflozin or placebo in addition to standard care.
Taking dapagliflozin carries risks of hypotension, renal impairment, hypoglycemia, and other concerns. The most common adverse reactions (5% or greater incidence) include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Full prescribing information can be found on the agency’s website.
The Food and Drug Administration has given Fast Track designation to the development of dapagliflozin (Farxiga) to delay progression of renal failure and to prevent cardiovascular and renal death in patients with chronic kidney disease with and without type 2 diabetes, according to a release from AstraZeneca.
The Fast Track designation is meant to accelerate the development and review process for the treatment of serious conditions that have unmet therapeutic needs.
Dapagliflozin, an oral daily sodium-glucose transporter 2 inhibitor, is approved both as a monotherapy and a component of combination therapy for the improvement of glycemic control in patients with type 2 diabetes, according to the release. It is given as an adjunct to diet and exercise, and has also shown additional benefits of weight loss and reduction in blood pressure.
A phase 3, randomized, placebo-controlled trial, DAPA-CVD (NCT03036150), is currently underway to evaluate the drug’s efficacy specifically in terms of renal outcomes and cardiovascular mortality in patients with chronic kidney disease, with and without type 2 diabetes. Participants receive once-daily dapagliflozin or placebo in addition to standard care.
Taking dapagliflozin carries risks of hypotension, renal impairment, hypoglycemia, and other concerns. The most common adverse reactions (5% or greater incidence) include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Full prescribing information can be found on the agency’s website.
Disputes over malpractice blame: Do allocations matter?
When the summons arrived, Nataly Minkina, MD, took one look at the lawsuit and fainted.
The Boston-area internist had treated the plaintiff just once while covering for the patient’s primary care physician. During a visit for an upper respiratory infection, the patient mentioned a lump in her breast, and Dr. Minkina confirmed a small thickening in the woman’s right breast. She sent the patient for a mammogram and ultrasound, the results of which the radiologist reported were normal, according to court documents.
Five years later, the patient claimed Dr. Minkina was one of several providers responsible for a missed breast cancer diagnosis.
Even worse than the lawsuit, however, was how her former insurer resolved the case, said Dr. Minkina, now an internist at Brigham and Women’s Hospital in Chestnut Hill, Mass. The claim was settled against the defendants for $500,000, and Dr. Minkina was alloted 30% of the liability. No fault was assigned to the other physicians named, while a nurse practitioner was alloted 10%, and the medical practice was alloted 60% liability, according to court documents.
“I was very upset,” Dr. Minkina said. “First of all, I was kept in the dark. Nobody ever talked to me. I did not get a single report or any document from my attorney in 12 months. When I asked why was I assigned the [30%] liability, they said the experts gave me bad evaluations, but they would not show reports to me. I was literally scapegoated.”
When the insurer refused to reconsider the allocation, Dr. Minkina took her complaint to court. The internist now has been embroiled in a legal challenge against Medical Professional Mutual Insurance Company (ProMutual) for 7 years. Dr. Minkina’s lawsuit alleges the insurer engaged in a bad faith allocation to serve its own economic interests by shifting fault for the claim from its insureds to its former client, Dr. Minkina. The insurance company contends the allocation was a careful and rational decision based on case evidence. In late July, the case went to trial in Dedham, Mass.
ProMutual declined comment on the case; the insurer also would not address general questions about its allocation policies.
“I started this fight because I felt violated and betrayed, not to make money,” Dr. Minkina said. “I am not rich by a long shot, and I wanted to clear my name because [a] good name is all I have. Additionally, having [a] record about malpractice payment in my physician profile makes me vulnerable.”
Liability experts say the case highlights the conflicts that can arise between physicians and insurers during malpractice lawsuits. The legal challenge also raises questions about allocations of liability by insurers, how the determinations are made, and what impact they have on doctors going forward.
The proportion of liability assigned after a settlement matters, said Jeffrey Segal, MD, JD, a neurosurgeon and founder of Medical Justice, a medicolegal consulting firm for physicians.
“There’s a subtext that your piece of the pie – the part that is allocated to you – is your liability, your culpability, your guilt,” Dr. Segal said in an interview. “This has impact going down the road in terms of reputation, in terms of credibility, and potentially of your premiums going forward. There are some real-world economic consequences.”
Bad care or bad faith?
In Dr. Minkina’s case, some facts are undisputed. In 2002, Dr. Minkina, then a physician at Blue Hills Medical Associates in Braintree, Mass., referred a 55-year-old patient for a mammogram and an ultrasound after confirming some nodularity in the women’s breast. A radiologist twice reported no abnormalities which Dr. Minkina relayed to the patient, advising her to follow-up with her primary care physician and to schedule yearly mammograms. The patient did neither, according to court records. Dr. Minkina left the practice shortly after the visit.
In early 2006, the patient visited the practice, and a nurse practitioner sent her for another mammogram and an ultrasound. The mammogram report included some signs of malignancy, but the nurse misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent a brain MRI and a breast MRI, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.
The agreement between parties ends there. Dr. Minkina believes she followed the standard of care and was not responsible for the delayed breast cancer diagnosis. Given the radiologist’s negative report and the patient’s lack of visual abnormalities, she contends she adequately referred the patient to her primary care physician for further consultation and evaluation. Dr. Minkina argues the insurer allocated an unjustifiably high percentage of liability to her because she was no longer an insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.
ProMutual contends Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of violations of standards of care and because of causation factors. The insurer’s experts asserted that when treating an older woman with a palpable lump, the standard of care is to obtain a biopsy, according to opening arguments by ProMutual defense counsel Tamara Wolfson.
The experts also concluded that, when the nurse practitioner and primary care physician saw the patient in 2006, the patient would have already had metastatic disease, and a cancer diagnosis at that time would not have saved her, according to court transcripts. Had the cancer been diagnosed in 2002 when Dr. Minkina saw the patient, the disease would have been “very treatable,” the experts further concluded.
“So, faced with negative opinions on both the standard of care and causation, [the claim representative] was very concerned that Dr. Minkina not only faced a very substantial risk of an adverse verdict in the ... suit, but a verdict that would exceed Dr. Minkina’s policy limits,” Ms. Wolfson said during opening arguments.
The evidence led to the settlement and the allocation decision, Ms. Wolfson said, adding that the majority – 60% – fell on Blue Hills Medical Associates because it lacked a good system to track and follow up with patients. There was zero benefit to ProMutual as to how the $500,000 settlement was parsed, she said during trial.
A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.”
Dr. Minkina had been a plaintiff in unrelated litigation in the past. In 2005, she sued her former employer for alleged discrimination and retaliation after claiming she was mistreated and terminated for complaining about fumes. She prevailed and was awarded an arbitration award of about $266,000. In 2009, Dr. Minkina sued the original law firm that represented her in the discrimination suit for malpractice, alleging the firm’s negligence cost her the chance to go to trial. A judge dismissed the claim as frivolous and ordered Dr. Minkina to pay the firm’s legal fees. The doctor twice has been jailed for failing to fully resolve that legal payment. The case remains outstanding, and Dr. Minkina is now in bankruptcy.
What’s in an allocation?
Liability allocations are an integral part of multiparty medical malpractice claims, said Brian Atchinson, president and CEO for the Medical Professional Liability Association, a trade association for medical liability insurers.
“In any case involving more than one party, there is a potential allocation issue,” Mr. Atchinson said in an interview. “[Insurers] generally look to the liability and damages incurred with regard to their respective insureds in a case and work to establish an allocation that reflects actual liability.”
If the case goes to a jury and jurors find for the plaintiff, depending on the nature of the damages awarded, the jury may be called on to allocate liability among multiple defendants, he said.
Because settlements are reported to the National Practitioner Data Bank (NPDB), the proportion of liability assigned to each defendant has significance, said J. Richard Moore, a medical liability defense attorney based in Indianapolis and chair for the Defense Research Institute’s Medical Liability and Health Care Law Committee.
“The allocation matters because the amount of settlement matters,” Mr. Moore said. “A lower settlement amount suggests the physician’s insurance company made a cost-benefit business decision to end litigation without more expense, while an extremely high settlement suggests actual malpractice.”
State medical boards have varying reporting requirements. Some state boards require both the amount paid by the individual provider and the global settlement amount – if known – while other state boards require only the amount paid on behalf of the provider.
Conflicts over allocations are not common, Dr. Segal said. More frequent are disputes among physicians and insurers over the potential settling of a claim. Such conflicts underscore the importance of paying close attention to contract language when signing with an insurer, Dr. Segal said.
Whether the contract includes a consent to settle clause, for example, can markedly change the case outcome. The clause means the insurer must have the doctor’s approval to settle the case. Absent the clause, insurers generally have authority to settle all claims arising under the policy.
Other contracts may include a “hammer clause,” Dr. Segal notes. This gives doctors the ultimate vote on settling, but it stipulates that if the physician refuses a settlement offer and opts for trial, the doctor is responsible for any surplus award, should the doctor lose.
In Dr. Minkina’s case, the doctor’s contract allowed ProMutual to settle without her consent, but the contract was silent on allocations.
Dr. Segal and Mr. Moore both said the odds of Dr. Minkina prevailing are fairly low. In another case, a South Carolina doctor similarly sued the South Carolina Medical Malpractice Liability Joint Underwriting Association over an allocation of liability following a settlement. The doctor claimed he should not be assigned any portion of the $500,000 settlement, and he sued after his insurer assigned him one-seventh liability.
A trial court found in his favor, ruling the insurer breached the covenant of good faith and fair dealing by failing to treat each physician equally when determining liability. The Supreme Court of South Carolina in 2001 overturned that decision, finding the evidence did not support a bad faith finding and that the insurer’s allocation decision was reasonable.
If the Massachusetts case ends in Dr. Minkina’s favor, it will be as a result of strong evidence that the insurer placed its interests ahead of the physician’s financial and other interests, Mr. Moore said.
“If that happens, I anticipate that insurers may revise their standard policy provisions to clarify and limit the extent to which physicians have the right to be involved in allocation decisions,” he said.
When the summons arrived, Nataly Minkina, MD, took one look at the lawsuit and fainted.
The Boston-area internist had treated the plaintiff just once while covering for the patient’s primary care physician. During a visit for an upper respiratory infection, the patient mentioned a lump in her breast, and Dr. Minkina confirmed a small thickening in the woman’s right breast. She sent the patient for a mammogram and ultrasound, the results of which the radiologist reported were normal, according to court documents.
Five years later, the patient claimed Dr. Minkina was one of several providers responsible for a missed breast cancer diagnosis.
Even worse than the lawsuit, however, was how her former insurer resolved the case, said Dr. Minkina, now an internist at Brigham and Women’s Hospital in Chestnut Hill, Mass. The claim was settled against the defendants for $500,000, and Dr. Minkina was alloted 30% of the liability. No fault was assigned to the other physicians named, while a nurse practitioner was alloted 10%, and the medical practice was alloted 60% liability, according to court documents.
“I was very upset,” Dr. Minkina said. “First of all, I was kept in the dark. Nobody ever talked to me. I did not get a single report or any document from my attorney in 12 months. When I asked why was I assigned the [30%] liability, they said the experts gave me bad evaluations, but they would not show reports to me. I was literally scapegoated.”
When the insurer refused to reconsider the allocation, Dr. Minkina took her complaint to court. The internist now has been embroiled in a legal challenge against Medical Professional Mutual Insurance Company (ProMutual) for 7 years. Dr. Minkina’s lawsuit alleges the insurer engaged in a bad faith allocation to serve its own economic interests by shifting fault for the claim from its insureds to its former client, Dr. Minkina. The insurance company contends the allocation was a careful and rational decision based on case evidence. In late July, the case went to trial in Dedham, Mass.
ProMutual declined comment on the case; the insurer also would not address general questions about its allocation policies.
“I started this fight because I felt violated and betrayed, not to make money,” Dr. Minkina said. “I am not rich by a long shot, and I wanted to clear my name because [a] good name is all I have. Additionally, having [a] record about malpractice payment in my physician profile makes me vulnerable.”
Liability experts say the case highlights the conflicts that can arise between physicians and insurers during malpractice lawsuits. The legal challenge also raises questions about allocations of liability by insurers, how the determinations are made, and what impact they have on doctors going forward.
The proportion of liability assigned after a settlement matters, said Jeffrey Segal, MD, JD, a neurosurgeon and founder of Medical Justice, a medicolegal consulting firm for physicians.
“There’s a subtext that your piece of the pie – the part that is allocated to you – is your liability, your culpability, your guilt,” Dr. Segal said in an interview. “This has impact going down the road in terms of reputation, in terms of credibility, and potentially of your premiums going forward. There are some real-world economic consequences.”
Bad care or bad faith?
In Dr. Minkina’s case, some facts are undisputed. In 2002, Dr. Minkina, then a physician at Blue Hills Medical Associates in Braintree, Mass., referred a 55-year-old patient for a mammogram and an ultrasound after confirming some nodularity in the women’s breast. A radiologist twice reported no abnormalities which Dr. Minkina relayed to the patient, advising her to follow-up with her primary care physician and to schedule yearly mammograms. The patient did neither, according to court records. Dr. Minkina left the practice shortly after the visit.
In early 2006, the patient visited the practice, and a nurse practitioner sent her for another mammogram and an ultrasound. The mammogram report included some signs of malignancy, but the nurse misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent a brain MRI and a breast MRI, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.
The agreement between parties ends there. Dr. Minkina believes she followed the standard of care and was not responsible for the delayed breast cancer diagnosis. Given the radiologist’s negative report and the patient’s lack of visual abnormalities, she contends she adequately referred the patient to her primary care physician for further consultation and evaluation. Dr. Minkina argues the insurer allocated an unjustifiably high percentage of liability to her because she was no longer an insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.
ProMutual contends Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of violations of standards of care and because of causation factors. The insurer’s experts asserted that when treating an older woman with a palpable lump, the standard of care is to obtain a biopsy, according to opening arguments by ProMutual defense counsel Tamara Wolfson.
The experts also concluded that, when the nurse practitioner and primary care physician saw the patient in 2006, the patient would have already had metastatic disease, and a cancer diagnosis at that time would not have saved her, according to court transcripts. Had the cancer been diagnosed in 2002 when Dr. Minkina saw the patient, the disease would have been “very treatable,” the experts further concluded.
“So, faced with negative opinions on both the standard of care and causation, [the claim representative] was very concerned that Dr. Minkina not only faced a very substantial risk of an adverse verdict in the ... suit, but a verdict that would exceed Dr. Minkina’s policy limits,” Ms. Wolfson said during opening arguments.
The evidence led to the settlement and the allocation decision, Ms. Wolfson said, adding that the majority – 60% – fell on Blue Hills Medical Associates because it lacked a good system to track and follow up with patients. There was zero benefit to ProMutual as to how the $500,000 settlement was parsed, she said during trial.
A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.”
Dr. Minkina had been a plaintiff in unrelated litigation in the past. In 2005, she sued her former employer for alleged discrimination and retaliation after claiming she was mistreated and terminated for complaining about fumes. She prevailed and was awarded an arbitration award of about $266,000. In 2009, Dr. Minkina sued the original law firm that represented her in the discrimination suit for malpractice, alleging the firm’s negligence cost her the chance to go to trial. A judge dismissed the claim as frivolous and ordered Dr. Minkina to pay the firm’s legal fees. The doctor twice has been jailed for failing to fully resolve that legal payment. The case remains outstanding, and Dr. Minkina is now in bankruptcy.
What’s in an allocation?
Liability allocations are an integral part of multiparty medical malpractice claims, said Brian Atchinson, president and CEO for the Medical Professional Liability Association, a trade association for medical liability insurers.
“In any case involving more than one party, there is a potential allocation issue,” Mr. Atchinson said in an interview. “[Insurers] generally look to the liability and damages incurred with regard to their respective insureds in a case and work to establish an allocation that reflects actual liability.”
If the case goes to a jury and jurors find for the plaintiff, depending on the nature of the damages awarded, the jury may be called on to allocate liability among multiple defendants, he said.
Because settlements are reported to the National Practitioner Data Bank (NPDB), the proportion of liability assigned to each defendant has significance, said J. Richard Moore, a medical liability defense attorney based in Indianapolis and chair for the Defense Research Institute’s Medical Liability and Health Care Law Committee.
“The allocation matters because the amount of settlement matters,” Mr. Moore said. “A lower settlement amount suggests the physician’s insurance company made a cost-benefit business decision to end litigation without more expense, while an extremely high settlement suggests actual malpractice.”
State medical boards have varying reporting requirements. Some state boards require both the amount paid by the individual provider and the global settlement amount – if known – while other state boards require only the amount paid on behalf of the provider.
Conflicts over allocations are not common, Dr. Segal said. More frequent are disputes among physicians and insurers over the potential settling of a claim. Such conflicts underscore the importance of paying close attention to contract language when signing with an insurer, Dr. Segal said.
Whether the contract includes a consent to settle clause, for example, can markedly change the case outcome. The clause means the insurer must have the doctor’s approval to settle the case. Absent the clause, insurers generally have authority to settle all claims arising under the policy.
Other contracts may include a “hammer clause,” Dr. Segal notes. This gives doctors the ultimate vote on settling, but it stipulates that if the physician refuses a settlement offer and opts for trial, the doctor is responsible for any surplus award, should the doctor lose.
In Dr. Minkina’s case, the doctor’s contract allowed ProMutual to settle without her consent, but the contract was silent on allocations.
Dr. Segal and Mr. Moore both said the odds of Dr. Minkina prevailing are fairly low. In another case, a South Carolina doctor similarly sued the South Carolina Medical Malpractice Liability Joint Underwriting Association over an allocation of liability following a settlement. The doctor claimed he should not be assigned any portion of the $500,000 settlement, and he sued after his insurer assigned him one-seventh liability.
A trial court found in his favor, ruling the insurer breached the covenant of good faith and fair dealing by failing to treat each physician equally when determining liability. The Supreme Court of South Carolina in 2001 overturned that decision, finding the evidence did not support a bad faith finding and that the insurer’s allocation decision was reasonable.
If the Massachusetts case ends in Dr. Minkina’s favor, it will be as a result of strong evidence that the insurer placed its interests ahead of the physician’s financial and other interests, Mr. Moore said.
“If that happens, I anticipate that insurers may revise their standard policy provisions to clarify and limit the extent to which physicians have the right to be involved in allocation decisions,” he said.
When the summons arrived, Nataly Minkina, MD, took one look at the lawsuit and fainted.
The Boston-area internist had treated the plaintiff just once while covering for the patient’s primary care physician. During a visit for an upper respiratory infection, the patient mentioned a lump in her breast, and Dr. Minkina confirmed a small thickening in the woman’s right breast. She sent the patient for a mammogram and ultrasound, the results of which the radiologist reported were normal, according to court documents.
Five years later, the patient claimed Dr. Minkina was one of several providers responsible for a missed breast cancer diagnosis.
Even worse than the lawsuit, however, was how her former insurer resolved the case, said Dr. Minkina, now an internist at Brigham and Women’s Hospital in Chestnut Hill, Mass. The claim was settled against the defendants for $500,000, and Dr. Minkina was alloted 30% of the liability. No fault was assigned to the other physicians named, while a nurse practitioner was alloted 10%, and the medical practice was alloted 60% liability, according to court documents.
“I was very upset,” Dr. Minkina said. “First of all, I was kept in the dark. Nobody ever talked to me. I did not get a single report or any document from my attorney in 12 months. When I asked why was I assigned the [30%] liability, they said the experts gave me bad evaluations, but they would not show reports to me. I was literally scapegoated.”
When the insurer refused to reconsider the allocation, Dr. Minkina took her complaint to court. The internist now has been embroiled in a legal challenge against Medical Professional Mutual Insurance Company (ProMutual) for 7 years. Dr. Minkina’s lawsuit alleges the insurer engaged in a bad faith allocation to serve its own economic interests by shifting fault for the claim from its insureds to its former client, Dr. Minkina. The insurance company contends the allocation was a careful and rational decision based on case evidence. In late July, the case went to trial in Dedham, Mass.
ProMutual declined comment on the case; the insurer also would not address general questions about its allocation policies.
“I started this fight because I felt violated and betrayed, not to make money,” Dr. Minkina said. “I am not rich by a long shot, and I wanted to clear my name because [a] good name is all I have. Additionally, having [a] record about malpractice payment in my physician profile makes me vulnerable.”
Liability experts say the case highlights the conflicts that can arise between physicians and insurers during malpractice lawsuits. The legal challenge also raises questions about allocations of liability by insurers, how the determinations are made, and what impact they have on doctors going forward.
The proportion of liability assigned after a settlement matters, said Jeffrey Segal, MD, JD, a neurosurgeon and founder of Medical Justice, a medicolegal consulting firm for physicians.
“There’s a subtext that your piece of the pie – the part that is allocated to you – is your liability, your culpability, your guilt,” Dr. Segal said in an interview. “This has impact going down the road in terms of reputation, in terms of credibility, and potentially of your premiums going forward. There are some real-world economic consequences.”
Bad care or bad faith?
In Dr. Minkina’s case, some facts are undisputed. In 2002, Dr. Minkina, then a physician at Blue Hills Medical Associates in Braintree, Mass., referred a 55-year-old patient for a mammogram and an ultrasound after confirming some nodularity in the women’s breast. A radiologist twice reported no abnormalities which Dr. Minkina relayed to the patient, advising her to follow-up with her primary care physician and to schedule yearly mammograms. The patient did neither, according to court records. Dr. Minkina left the practice shortly after the visit.
In early 2006, the patient visited the practice, and a nurse practitioner sent her for another mammogram and an ultrasound. The mammogram report included some signs of malignancy, but the nurse misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent a brain MRI and a breast MRI, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.
The agreement between parties ends there. Dr. Minkina believes she followed the standard of care and was not responsible for the delayed breast cancer diagnosis. Given the radiologist’s negative report and the patient’s lack of visual abnormalities, she contends she adequately referred the patient to her primary care physician for further consultation and evaluation. Dr. Minkina argues the insurer allocated an unjustifiably high percentage of liability to her because she was no longer an insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.
ProMutual contends Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of violations of standards of care and because of causation factors. The insurer’s experts asserted that when treating an older woman with a palpable lump, the standard of care is to obtain a biopsy, according to opening arguments by ProMutual defense counsel Tamara Wolfson.
The experts also concluded that, when the nurse practitioner and primary care physician saw the patient in 2006, the patient would have already had metastatic disease, and a cancer diagnosis at that time would not have saved her, according to court transcripts. Had the cancer been diagnosed in 2002 when Dr. Minkina saw the patient, the disease would have been “very treatable,” the experts further concluded.
“So, faced with negative opinions on both the standard of care and causation, [the claim representative] was very concerned that Dr. Minkina not only faced a very substantial risk of an adverse verdict in the ... suit, but a verdict that would exceed Dr. Minkina’s policy limits,” Ms. Wolfson said during opening arguments.
The evidence led to the settlement and the allocation decision, Ms. Wolfson said, adding that the majority – 60% – fell on Blue Hills Medical Associates because it lacked a good system to track and follow up with patients. There was zero benefit to ProMutual as to how the $500,000 settlement was parsed, she said during trial.
A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.”
Dr. Minkina had been a plaintiff in unrelated litigation in the past. In 2005, she sued her former employer for alleged discrimination and retaliation after claiming she was mistreated and terminated for complaining about fumes. She prevailed and was awarded an arbitration award of about $266,000. In 2009, Dr. Minkina sued the original law firm that represented her in the discrimination suit for malpractice, alleging the firm’s negligence cost her the chance to go to trial. A judge dismissed the claim as frivolous and ordered Dr. Minkina to pay the firm’s legal fees. The doctor twice has been jailed for failing to fully resolve that legal payment. The case remains outstanding, and Dr. Minkina is now in bankruptcy.
What’s in an allocation?
Liability allocations are an integral part of multiparty medical malpractice claims, said Brian Atchinson, president and CEO for the Medical Professional Liability Association, a trade association for medical liability insurers.
“In any case involving more than one party, there is a potential allocation issue,” Mr. Atchinson said in an interview. “[Insurers] generally look to the liability and damages incurred with regard to their respective insureds in a case and work to establish an allocation that reflects actual liability.”
If the case goes to a jury and jurors find for the plaintiff, depending on the nature of the damages awarded, the jury may be called on to allocate liability among multiple defendants, he said.
Because settlements are reported to the National Practitioner Data Bank (NPDB), the proportion of liability assigned to each defendant has significance, said J. Richard Moore, a medical liability defense attorney based in Indianapolis and chair for the Defense Research Institute’s Medical Liability and Health Care Law Committee.
“The allocation matters because the amount of settlement matters,” Mr. Moore said. “A lower settlement amount suggests the physician’s insurance company made a cost-benefit business decision to end litigation without more expense, while an extremely high settlement suggests actual malpractice.”
State medical boards have varying reporting requirements. Some state boards require both the amount paid by the individual provider and the global settlement amount – if known – while other state boards require only the amount paid on behalf of the provider.
Conflicts over allocations are not common, Dr. Segal said. More frequent are disputes among physicians and insurers over the potential settling of a claim. Such conflicts underscore the importance of paying close attention to contract language when signing with an insurer, Dr. Segal said.
Whether the contract includes a consent to settle clause, for example, can markedly change the case outcome. The clause means the insurer must have the doctor’s approval to settle the case. Absent the clause, insurers generally have authority to settle all claims arising under the policy.
Other contracts may include a “hammer clause,” Dr. Segal notes. This gives doctors the ultimate vote on settling, but it stipulates that if the physician refuses a settlement offer and opts for trial, the doctor is responsible for any surplus award, should the doctor lose.
In Dr. Minkina’s case, the doctor’s contract allowed ProMutual to settle without her consent, but the contract was silent on allocations.
Dr. Segal and Mr. Moore both said the odds of Dr. Minkina prevailing are fairly low. In another case, a South Carolina doctor similarly sued the South Carolina Medical Malpractice Liability Joint Underwriting Association over an allocation of liability following a settlement. The doctor claimed he should not be assigned any portion of the $500,000 settlement, and he sued after his insurer assigned him one-seventh liability.
A trial court found in his favor, ruling the insurer breached the covenant of good faith and fair dealing by failing to treat each physician equally when determining liability. The Supreme Court of South Carolina in 2001 overturned that decision, finding the evidence did not support a bad faith finding and that the insurer’s allocation decision was reasonable.
If the Massachusetts case ends in Dr. Minkina’s favor, it will be as a result of strong evidence that the insurer placed its interests ahead of the physician’s financial and other interests, Mr. Moore said.
“If that happens, I anticipate that insurers may revise their standard policy provisions to clarify and limit the extent to which physicians have the right to be involved in allocation decisions,” he said.
Zoledronate maintains bone loss after denosumab discontinuation
Women with postmenopausal osteoporosis who discontinued denosumab treatment after achieving osteopenia maintained bone mineral density at the spine and hip with a single infusion of zoledronate given 6 months after the last infusion of denosumab, according to results from a small, multicenter, randomized trial published in the Journal of Bone and Mineral Research.
The cessation of the monoclonal antibody denosumab is typically followed by a “rebound phenomenon” often attributed to an increase in bone turnover above pretreatment values caused by the up-regulation of osteoclastogenesis, according to Athanasios D. Anastasilakis, MD, of 424 General Military Hospital, Thessaloníki, Greece, and colleagues. Guidelines recommend that patients take a bisphosphonate to prevent this effect, but the optimal bisphosphonate regimen is unknown and evidence is inconsistent.
To address this question, the investigators randomized 57 postmenopausal women with osteoporosis who had received six monthly injections of denosumab (for an average of 2.2 years) and had achieved nonosteoporotic bone mineral density (BMD) T scores greater than –2.5 but no greater than –1 at the hip or the spine. A total of 27 received a single IV infusion of zoledronate 5 mg given 6 months after the last denosumab injection with a 3-week window, and 30 continued denosumab and received two additional monthly 60-mg injections. Following either the zoledronate infusion or the last denosumab injection, all women received no treatment and were followed until 2 years from randomization. All women were given vitamin D supplements and were seen in clinic appointments at baseline, 6, 12, 15, 18, and 24 months.
Areal BMD of the lumbar spine and femoral neck of the nondominant hip were measured at baseline, 12, and 24 months by dual-energy x-ray absorptiometry, and least significant changes were 5% or less at the spine and 4% or less at the femoral neck, based on proposals from the International Foundation for Osteoporosis and the National Osteoporosis Foundation USA.
At 24 months, lumbar spine BMD (LS‐BMD) returned to baseline in the zoledronate group, but decreased in the denosumab group by 4.82% from the 12‐month value (P less than .001).
The difference in LS-BMD changes between the two groups from month 12 to 24, the primary endpoint of the study, was statistically significant (–0.018 with zoledronate vs. –0.045 with denosumab; P = .025). Differences in changes of femoral neck BMD were also statistically significant (–0.004 with zoledronate vs. –0.038 with denosumab; P = .005), the researchers reported.
The differences in BMD changes between the two groups 24 and 12 months after discontinuation of denosumab (6 months after the last injection) for the zoledronate and denosumab group respectively were also statistically significant both at the lumbar spine (–0.002 with zoledronate vs. –0.045 with denosumab; P = .03) and at the femoral neck (–0.004 with zoledronate vs. –0.038 with denosumab; P = .007).
The authors observed no relationship between the number of denosumab injections and LS-BMD changes in either group of women; however, they noted that responses of individual patients to zoledronate were variable. For example, three women who took zoledronate experienced decreases of LS-BMD greater than the least significant change observed at 24 months, a finding which could not be explained by the timing of the infusion, baseline rate of bone turnover, or baseline BMD.
“It appears that intrinsic factors that still need to be defined may affect the response of a few individuals,” they wrote.
This was further illustrated by one patient in the zoledronate group who sustained clinical vertebral fractures associated with significant, unexplained decreases of BMD that could not be prevented with the zoledronate infusion.
“In clinical practice, it is, therefore, advisable to measure BMD at 12 months after the zoledronate infusion and decide whether additional treatment may be required,” the authors wrote.
Another significant finding reported by the authors was that neither baseline nor 12‐month bone turnover marker (BTM) values were associated with BMD changes in either group of women during the entire study period.
“Particularly important for clinical practice was the lack of a relationship in zoledronate-treated women; even when women were divided according to baseline median BTM values (below or above) there were no significant difference in BMD changes at 12 or 24 months,” they wrote.
“In a substantial number of women in the denosumab group BTMs were still above the upper limit of normal of the postmenopausal age 18 months after the last Dmab [denosumab] injection but also in 7.4% of patients treated with zoledronate at 2 years,” they added.
“Whether in the latter patients BTMs were also increased before the start of Dmab treatment, as it is known to occur in some patients with osteoporosis, or are due to a prolonged effect of Dmab withdrawal on bone metabolism could not be prevented by zoledronate, is not known because pretreatment data were not available,” the study authors noted.
For adverse events, in addition to the one patient in the zoledronate group with clinical vertebral fractures, three patients in the denosumab group sustained vertebral fractures.
“Prevalent vertebral fractures have been previously reported as the most important risk factor for clinical vertebral fractures following cessation of Dmab therapy [which] strongly suggest that spine x-rays should be performed in all patients in whom discontinuation of Dmab treatment is considered,” the authors wrote.
“In most women with postmenopausal osteoporosis treated with [denosumab] in whom discontinuation of treatment is considered when a nonosteoporotic BMD is achieved, a single intravenous infusion of zoledronate 5 mg given 6 months after the last Dmab injection prevents bone loss for at least 2 years independently of the rate of bone turnover. Follow-up is recommended, as in a few patients treatment might not have the expected effect at 2 years for currently unknown reasons,” they concluded.
The study was funded by institutional funds and the Hellenic Endocrine Society. Several authors reported receiving consulting or lecture fees from Amgen, which markets denosumab, as well as other pharmaceutical companies.
SOURCE: Anastasilakis A et al. J Bone Miner Res. 2019 Aug 21. doi: 10.1002/jbmr.3853.
Women with postmenopausal osteoporosis who discontinued denosumab treatment after achieving osteopenia maintained bone mineral density at the spine and hip with a single infusion of zoledronate given 6 months after the last infusion of denosumab, according to results from a small, multicenter, randomized trial published in the Journal of Bone and Mineral Research.
The cessation of the monoclonal antibody denosumab is typically followed by a “rebound phenomenon” often attributed to an increase in bone turnover above pretreatment values caused by the up-regulation of osteoclastogenesis, according to Athanasios D. Anastasilakis, MD, of 424 General Military Hospital, Thessaloníki, Greece, and colleagues. Guidelines recommend that patients take a bisphosphonate to prevent this effect, but the optimal bisphosphonate regimen is unknown and evidence is inconsistent.
To address this question, the investigators randomized 57 postmenopausal women with osteoporosis who had received six monthly injections of denosumab (for an average of 2.2 years) and had achieved nonosteoporotic bone mineral density (BMD) T scores greater than –2.5 but no greater than –1 at the hip or the spine. A total of 27 received a single IV infusion of zoledronate 5 mg given 6 months after the last denosumab injection with a 3-week window, and 30 continued denosumab and received two additional monthly 60-mg injections. Following either the zoledronate infusion or the last denosumab injection, all women received no treatment and were followed until 2 years from randomization. All women were given vitamin D supplements and were seen in clinic appointments at baseline, 6, 12, 15, 18, and 24 months.
Areal BMD of the lumbar spine and femoral neck of the nondominant hip were measured at baseline, 12, and 24 months by dual-energy x-ray absorptiometry, and least significant changes were 5% or less at the spine and 4% or less at the femoral neck, based on proposals from the International Foundation for Osteoporosis and the National Osteoporosis Foundation USA.
At 24 months, lumbar spine BMD (LS‐BMD) returned to baseline in the zoledronate group, but decreased in the denosumab group by 4.82% from the 12‐month value (P less than .001).
The difference in LS-BMD changes between the two groups from month 12 to 24, the primary endpoint of the study, was statistically significant (–0.018 with zoledronate vs. –0.045 with denosumab; P = .025). Differences in changes of femoral neck BMD were also statistically significant (–0.004 with zoledronate vs. –0.038 with denosumab; P = .005), the researchers reported.
The differences in BMD changes between the two groups 24 and 12 months after discontinuation of denosumab (6 months after the last injection) for the zoledronate and denosumab group respectively were also statistically significant both at the lumbar spine (–0.002 with zoledronate vs. –0.045 with denosumab; P = .03) and at the femoral neck (–0.004 with zoledronate vs. –0.038 with denosumab; P = .007).
The authors observed no relationship between the number of denosumab injections and LS-BMD changes in either group of women; however, they noted that responses of individual patients to zoledronate were variable. For example, three women who took zoledronate experienced decreases of LS-BMD greater than the least significant change observed at 24 months, a finding which could not be explained by the timing of the infusion, baseline rate of bone turnover, or baseline BMD.
“It appears that intrinsic factors that still need to be defined may affect the response of a few individuals,” they wrote.
This was further illustrated by one patient in the zoledronate group who sustained clinical vertebral fractures associated with significant, unexplained decreases of BMD that could not be prevented with the zoledronate infusion.
“In clinical practice, it is, therefore, advisable to measure BMD at 12 months after the zoledronate infusion and decide whether additional treatment may be required,” the authors wrote.
Another significant finding reported by the authors was that neither baseline nor 12‐month bone turnover marker (BTM) values were associated with BMD changes in either group of women during the entire study period.
“Particularly important for clinical practice was the lack of a relationship in zoledronate-treated women; even when women were divided according to baseline median BTM values (below or above) there were no significant difference in BMD changes at 12 or 24 months,” they wrote.
“In a substantial number of women in the denosumab group BTMs were still above the upper limit of normal of the postmenopausal age 18 months after the last Dmab [denosumab] injection but also in 7.4% of patients treated with zoledronate at 2 years,” they added.
“Whether in the latter patients BTMs were also increased before the start of Dmab treatment, as it is known to occur in some patients with osteoporosis, or are due to a prolonged effect of Dmab withdrawal on bone metabolism could not be prevented by zoledronate, is not known because pretreatment data were not available,” the study authors noted.
For adverse events, in addition to the one patient in the zoledronate group with clinical vertebral fractures, three patients in the denosumab group sustained vertebral fractures.
“Prevalent vertebral fractures have been previously reported as the most important risk factor for clinical vertebral fractures following cessation of Dmab therapy [which] strongly suggest that spine x-rays should be performed in all patients in whom discontinuation of Dmab treatment is considered,” the authors wrote.
“In most women with postmenopausal osteoporosis treated with [denosumab] in whom discontinuation of treatment is considered when a nonosteoporotic BMD is achieved, a single intravenous infusion of zoledronate 5 mg given 6 months after the last Dmab injection prevents bone loss for at least 2 years independently of the rate of bone turnover. Follow-up is recommended, as in a few patients treatment might not have the expected effect at 2 years for currently unknown reasons,” they concluded.
The study was funded by institutional funds and the Hellenic Endocrine Society. Several authors reported receiving consulting or lecture fees from Amgen, which markets denosumab, as well as other pharmaceutical companies.
SOURCE: Anastasilakis A et al. J Bone Miner Res. 2019 Aug 21. doi: 10.1002/jbmr.3853.
Women with postmenopausal osteoporosis who discontinued denosumab treatment after achieving osteopenia maintained bone mineral density at the spine and hip with a single infusion of zoledronate given 6 months after the last infusion of denosumab, according to results from a small, multicenter, randomized trial published in the Journal of Bone and Mineral Research.
The cessation of the monoclonal antibody denosumab is typically followed by a “rebound phenomenon” often attributed to an increase in bone turnover above pretreatment values caused by the up-regulation of osteoclastogenesis, according to Athanasios D. Anastasilakis, MD, of 424 General Military Hospital, Thessaloníki, Greece, and colleagues. Guidelines recommend that patients take a bisphosphonate to prevent this effect, but the optimal bisphosphonate regimen is unknown and evidence is inconsistent.
To address this question, the investigators randomized 57 postmenopausal women with osteoporosis who had received six monthly injections of denosumab (for an average of 2.2 years) and had achieved nonosteoporotic bone mineral density (BMD) T scores greater than –2.5 but no greater than –1 at the hip or the spine. A total of 27 received a single IV infusion of zoledronate 5 mg given 6 months after the last denosumab injection with a 3-week window, and 30 continued denosumab and received two additional monthly 60-mg injections. Following either the zoledronate infusion or the last denosumab injection, all women received no treatment and were followed until 2 years from randomization. All women were given vitamin D supplements and were seen in clinic appointments at baseline, 6, 12, 15, 18, and 24 months.
Areal BMD of the lumbar spine and femoral neck of the nondominant hip were measured at baseline, 12, and 24 months by dual-energy x-ray absorptiometry, and least significant changes were 5% or less at the spine and 4% or less at the femoral neck, based on proposals from the International Foundation for Osteoporosis and the National Osteoporosis Foundation USA.
At 24 months, lumbar spine BMD (LS‐BMD) returned to baseline in the zoledronate group, but decreased in the denosumab group by 4.82% from the 12‐month value (P less than .001).
The difference in LS-BMD changes between the two groups from month 12 to 24, the primary endpoint of the study, was statistically significant (–0.018 with zoledronate vs. –0.045 with denosumab; P = .025). Differences in changes of femoral neck BMD were also statistically significant (–0.004 with zoledronate vs. –0.038 with denosumab; P = .005), the researchers reported.
The differences in BMD changes between the two groups 24 and 12 months after discontinuation of denosumab (6 months after the last injection) for the zoledronate and denosumab group respectively were also statistically significant both at the lumbar spine (–0.002 with zoledronate vs. –0.045 with denosumab; P = .03) and at the femoral neck (–0.004 with zoledronate vs. –0.038 with denosumab; P = .007).
The authors observed no relationship between the number of denosumab injections and LS-BMD changes in either group of women; however, they noted that responses of individual patients to zoledronate were variable. For example, three women who took zoledronate experienced decreases of LS-BMD greater than the least significant change observed at 24 months, a finding which could not be explained by the timing of the infusion, baseline rate of bone turnover, or baseline BMD.
“It appears that intrinsic factors that still need to be defined may affect the response of a few individuals,” they wrote.
This was further illustrated by one patient in the zoledronate group who sustained clinical vertebral fractures associated with significant, unexplained decreases of BMD that could not be prevented with the zoledronate infusion.
“In clinical practice, it is, therefore, advisable to measure BMD at 12 months after the zoledronate infusion and decide whether additional treatment may be required,” the authors wrote.
Another significant finding reported by the authors was that neither baseline nor 12‐month bone turnover marker (BTM) values were associated with BMD changes in either group of women during the entire study period.
“Particularly important for clinical practice was the lack of a relationship in zoledronate-treated women; even when women were divided according to baseline median BTM values (below or above) there were no significant difference in BMD changes at 12 or 24 months,” they wrote.
“In a substantial number of women in the denosumab group BTMs were still above the upper limit of normal of the postmenopausal age 18 months after the last Dmab [denosumab] injection but also in 7.4% of patients treated with zoledronate at 2 years,” they added.
“Whether in the latter patients BTMs were also increased before the start of Dmab treatment, as it is known to occur in some patients with osteoporosis, or are due to a prolonged effect of Dmab withdrawal on bone metabolism could not be prevented by zoledronate, is not known because pretreatment data were not available,” the study authors noted.
For adverse events, in addition to the one patient in the zoledronate group with clinical vertebral fractures, three patients in the denosumab group sustained vertebral fractures.
“Prevalent vertebral fractures have been previously reported as the most important risk factor for clinical vertebral fractures following cessation of Dmab therapy [which] strongly suggest that spine x-rays should be performed in all patients in whom discontinuation of Dmab treatment is considered,” the authors wrote.
“In most women with postmenopausal osteoporosis treated with [denosumab] in whom discontinuation of treatment is considered when a nonosteoporotic BMD is achieved, a single intravenous infusion of zoledronate 5 mg given 6 months after the last Dmab injection prevents bone loss for at least 2 years independently of the rate of bone turnover. Follow-up is recommended, as in a few patients treatment might not have the expected effect at 2 years for currently unknown reasons,” they concluded.
The study was funded by institutional funds and the Hellenic Endocrine Society. Several authors reported receiving consulting or lecture fees from Amgen, which markets denosumab, as well as other pharmaceutical companies.
SOURCE: Anastasilakis A et al. J Bone Miner Res. 2019 Aug 21. doi: 10.1002/jbmr.3853.
FROM THE JOURNAL OF BONE AND MINERAL RESEARCH
Novel conditioning regimen shows benefit for beta-thalassemia major
A novel transplant protocol (WZ-14-TM) improved survival outcomes and rates of graft-versus-host disease (GVHD) in patients with beta-thalassemia major undergoing hematopoietic stem cell transplant (HSCT) from an unrelated donor, according to findings from a single-center study.
“In August 2014, we began using WZ-14-TM in hopes of lowering the [graft failure] rate and transplant-related mortality,” Lan Sun, MD, of Wenzhou (China) Medical University and colleagues wrote in Biology of Blood and Marrow Transplantation.
The study cohort included 48 patients (aged 2-11 years) with beta-thalassemia major who underwent unrelated-donor HSCT from August 2014 to June 2018. Prior to transplantation, all participants received iron chelation therapy and regular red blood cell transfusions.
The original busulfan/cyclophosphamide–based conditioning regimen was modified to include antithymocyte globulin and fludarabine in order to reduce the risk of graft failure.
Additionally, the team lowered the cumulative dose of cyclophosphamide from 200 mg/kg to 100 mg/kg in an effort to lessen treatment-related toxicity.
After analysis, the researchers reported that the rates of thalassemia-free and overall survival were both 100%, while the incidence rates of acute (grade 2-4) and chronic GVHD were both 8.3%. In prior studies, the incidence rates of acute (grade 2-4) and chronic GVHD were 37%-42% and 14%-27%, respectively.
Neutrophil engraftment was achieved in a median duration of 13 days, while the median hemoglobin and platelet recovery times were 11 days and 12 days, respectively.
The low incidence of GVHD in their study may be related to the combination of antithymocyte globulin, cyclosporine A, mycophenolate mofetil, and methotrexate for GVHD prophylaxis, the researchers wrote.
They acknowledged two key limitations of the study were the small sample size and its single-center design. Accordingly, the findings should be validated in future studies.
The results suggest that the WZ-14-TM protocol is a “feasible and safe” conditioning regimen for patients with beta-thalassemia major undergoing unrelated-donor HSCT, they concluded.
The study was funded by the Public Welfare Science and Technology Project of Wenzhou, the Natural Science Foundation of Zhejiang Province, and the National Natural Science Foundation of China. The authors reported having no conflicts of interest.
SOURCE: Sun L et al. Biol Blood Marrow Transplant. 2019; 25(8):1592-6.
A novel transplant protocol (WZ-14-TM) improved survival outcomes and rates of graft-versus-host disease (GVHD) in patients with beta-thalassemia major undergoing hematopoietic stem cell transplant (HSCT) from an unrelated donor, according to findings from a single-center study.
“In August 2014, we began using WZ-14-TM in hopes of lowering the [graft failure] rate and transplant-related mortality,” Lan Sun, MD, of Wenzhou (China) Medical University and colleagues wrote in Biology of Blood and Marrow Transplantation.
The study cohort included 48 patients (aged 2-11 years) with beta-thalassemia major who underwent unrelated-donor HSCT from August 2014 to June 2018. Prior to transplantation, all participants received iron chelation therapy and regular red blood cell transfusions.
The original busulfan/cyclophosphamide–based conditioning regimen was modified to include antithymocyte globulin and fludarabine in order to reduce the risk of graft failure.
Additionally, the team lowered the cumulative dose of cyclophosphamide from 200 mg/kg to 100 mg/kg in an effort to lessen treatment-related toxicity.
After analysis, the researchers reported that the rates of thalassemia-free and overall survival were both 100%, while the incidence rates of acute (grade 2-4) and chronic GVHD were both 8.3%. In prior studies, the incidence rates of acute (grade 2-4) and chronic GVHD were 37%-42% and 14%-27%, respectively.
Neutrophil engraftment was achieved in a median duration of 13 days, while the median hemoglobin and platelet recovery times were 11 days and 12 days, respectively.
The low incidence of GVHD in their study may be related to the combination of antithymocyte globulin, cyclosporine A, mycophenolate mofetil, and methotrexate for GVHD prophylaxis, the researchers wrote.
They acknowledged two key limitations of the study were the small sample size and its single-center design. Accordingly, the findings should be validated in future studies.
The results suggest that the WZ-14-TM protocol is a “feasible and safe” conditioning regimen for patients with beta-thalassemia major undergoing unrelated-donor HSCT, they concluded.
The study was funded by the Public Welfare Science and Technology Project of Wenzhou, the Natural Science Foundation of Zhejiang Province, and the National Natural Science Foundation of China. The authors reported having no conflicts of interest.
SOURCE: Sun L et al. Biol Blood Marrow Transplant. 2019; 25(8):1592-6.
A novel transplant protocol (WZ-14-TM) improved survival outcomes and rates of graft-versus-host disease (GVHD) in patients with beta-thalassemia major undergoing hematopoietic stem cell transplant (HSCT) from an unrelated donor, according to findings from a single-center study.
“In August 2014, we began using WZ-14-TM in hopes of lowering the [graft failure] rate and transplant-related mortality,” Lan Sun, MD, of Wenzhou (China) Medical University and colleagues wrote in Biology of Blood and Marrow Transplantation.
The study cohort included 48 patients (aged 2-11 years) with beta-thalassemia major who underwent unrelated-donor HSCT from August 2014 to June 2018. Prior to transplantation, all participants received iron chelation therapy and regular red blood cell transfusions.
The original busulfan/cyclophosphamide–based conditioning regimen was modified to include antithymocyte globulin and fludarabine in order to reduce the risk of graft failure.
Additionally, the team lowered the cumulative dose of cyclophosphamide from 200 mg/kg to 100 mg/kg in an effort to lessen treatment-related toxicity.
After analysis, the researchers reported that the rates of thalassemia-free and overall survival were both 100%, while the incidence rates of acute (grade 2-4) and chronic GVHD were both 8.3%. In prior studies, the incidence rates of acute (grade 2-4) and chronic GVHD were 37%-42% and 14%-27%, respectively.
Neutrophil engraftment was achieved in a median duration of 13 days, while the median hemoglobin and platelet recovery times were 11 days and 12 days, respectively.
The low incidence of GVHD in their study may be related to the combination of antithymocyte globulin, cyclosporine A, mycophenolate mofetil, and methotrexate for GVHD prophylaxis, the researchers wrote.
They acknowledged two key limitations of the study were the small sample size and its single-center design. Accordingly, the findings should be validated in future studies.
The results suggest that the WZ-14-TM protocol is a “feasible and safe” conditioning regimen for patients with beta-thalassemia major undergoing unrelated-donor HSCT, they concluded.
The study was funded by the Public Welfare Science and Technology Project of Wenzhou, the Natural Science Foundation of Zhejiang Province, and the National Natural Science Foundation of China. The authors reported having no conflicts of interest.
SOURCE: Sun L et al. Biol Blood Marrow Transplant. 2019; 25(8):1592-6.
FROM BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
Prices, out-of-pocket costs for MS drugs rose despite competition
according to an analysis published in JAMA Neurology. The increased prices raise concern “because they demonstrate that the approval of new therapies did not ameliorate and could have even contributed to high inflation rates observed for incumbent drugs,” wrote the authors.
Four self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) were available before 2009, and seven new branded DMTs were introduced after that year. Previous research indicated that the prices of DMTs for MS increased at higher rates than the prices of drugs for other disorders. How these price increases affected pharmaceutical spending during the past decade is uncertain, however.
A review of Medicare claims data
Alvaro San-Juan-Rodriguez, PharmD, a fellow in pharmacoeconomics, outcomes, and pharmacoanalytics research at the University of Pittsburgh, and colleagues examined claims data from 2006 to 2016 from a 5% random sample of Medicare beneficiaries. Information for a mean of 2.8 million Medicare beneficiaries per year was available. The researchers extracted all prescription claims for self-administered DMTs for MS (that is, glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod, teriflunomide, dimethyl fumarate, and peginterferon beta-1a).
Dr. San-Juan-Rodriguez and associates chose three main outcomes. The first was the annual cost of treatment with each medication, which was based on Medicare Part D prescription claims gross costs and Food and Drug Administration–approved recommended dosing. The second was the market share of each medication, which the researchers defined as the proportion of pharmaceutical spending accounted for by each drug. The third was pharmaceutical spending per 1,000 Medicare beneficiaries for all drugs. The investigators also examined the relative contributions of Medicare Part D Plans’ payments, patients’ out-of-pocket costs, and other payments toward pharmaceutical spending.
Prices defied market expectations
The annual costs of treatment with self-administered DMTs for MS increased more than 300%. The mean annual cost was $18,660 in 2006 and $75,847 in 2016, and the mean annual rate of price increase was 12.8%. “Prices of most self-administered DMTs for MS increased in parallel, defying standard market expectations,” the investigators wrote.
Branded formulations of glatiramer acetate maintained the largest market share throughout the study period, ranging between 32.2% and 48.4%. However, the market share of platform therapies – glatiramer acetate, interferon beta-1a, and interferon beta-1b – decreased significantly from 2006 to 2016. Market shares for brand-name glatiramers declined from 36.7% to 32.2%, for intramuscular interferon beta-1a (30 mcg) from 32.3% to 14.2%, for interferon beta-1b from 18.7% to 4.5%, and for interferon beta-1a (8.8, 22, or 44 mcg) from 12.2% to 8.3%. The market shares of newer therapies, however, increased to 7.9% for fingolimod, 9.0% for teriflunomide, and 19.2% for dimethyl fumarate.
Pharmaceutical spending per 1,000 beneficiaries increased by a factor of 10.2 throughout the study period (from $7,794 to $79,411). Patients’ out-of-pocket spending per 1,000 beneficiaries increased by a factor of 7.2 (from $372 to $2,673). Furthermore, the relative contribution of federal payments toward pharmaceutical spending increased from 68.5% to 73.8%.
“Large increases in drug prices have not been specific to MS drugs,” said Dr. San-Juan-Rodriguez in an interview. “We previously described similar trends in other specialty medications used to treat severe disease states, such as tumor necrosis factor inhibitors [TNFi] for the treatment of rheumatoid arthritis. Yet these increases took place at a slower pace. For instance, list prices of TNFi increased at an average annual rate of 9.9% in the same time period, 2006-2016.
“It is important to acknowledge that rising list prices of drugs may partially reflect competition for rebates,” he added. “Yet the specific reasons behind the faster growth of prices of MS drugs, compared with the prices of drugs used in other disease states, remain uncertain.”
Neurologists should bear in mind that, although generic drugs are substantially cheaper than branded drugs, generic specialty medications do not always reduce costs for Medicare Part D beneficiaries. “On the contrary, due to incentive misalignments created by the Medicare Part D benefit design, beneficiaries using generic drugs such as Glatopa ... may pay more than those using the branded drug,” Dr. San-Juan-Rodriguez said.
What are neurologists’ responsibilities?
Although the original annual price of interferon beta-1b ($10,920) was stunning, physicians now recall it with nostalgia, wrote Daniel M. Hartung, PharmD, associate professor of biostatistics and epidemiology, and Dennis Bourdette, MD, professor of neurology, both at Oregon Health and Science University, Portland, in an accompanying editorial. “The prices for DMTs for MS have risen dramatically over the last 15 years, far outpacing inflation, and now have a mean price of more than $86,000 per year.”
Neurologists should be concerned about these rising prices, Dr. Hartung and Dr. Bourdette wrote. They should feel responsibility toward the health care system that pays for these medications, and toward patients who pay out of their own pockets. “Neurologists should be seeking to minimize the financial adverse effects of these therapies as much as they try to minimize physical adverse effects.”
One way for neurologists to address increasing prices is to urge state and federal lawmakers to pass legislation to curb them, they wrote. Neurologists also should reexamine their relationships with pharmaceutical and biotechnology companies. “Remaining silent should not be an option. ... Neurologists should not allow the unfettered increases in price for these drugs to hurt the health care system or patients.”
The Myers Family Foundation and the National Heart, Lung, and Blood Institute funded the research. Several authors are employees of health insurance companies such as the UPMC Health Plan Insurance Services Division and Humana. One author received personal fees from Pfizer that were unrelated to this study.
SOURCEs: San-Juan-Rodriguez A et al. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2711; Hartung DM and Bourdette D. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2445.
according to an analysis published in JAMA Neurology. The increased prices raise concern “because they demonstrate that the approval of new therapies did not ameliorate and could have even contributed to high inflation rates observed for incumbent drugs,” wrote the authors.
Four self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) were available before 2009, and seven new branded DMTs were introduced after that year. Previous research indicated that the prices of DMTs for MS increased at higher rates than the prices of drugs for other disorders. How these price increases affected pharmaceutical spending during the past decade is uncertain, however.
A review of Medicare claims data
Alvaro San-Juan-Rodriguez, PharmD, a fellow in pharmacoeconomics, outcomes, and pharmacoanalytics research at the University of Pittsburgh, and colleagues examined claims data from 2006 to 2016 from a 5% random sample of Medicare beneficiaries. Information for a mean of 2.8 million Medicare beneficiaries per year was available. The researchers extracted all prescription claims for self-administered DMTs for MS (that is, glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod, teriflunomide, dimethyl fumarate, and peginterferon beta-1a).
Dr. San-Juan-Rodriguez and associates chose three main outcomes. The first was the annual cost of treatment with each medication, which was based on Medicare Part D prescription claims gross costs and Food and Drug Administration–approved recommended dosing. The second was the market share of each medication, which the researchers defined as the proportion of pharmaceutical spending accounted for by each drug. The third was pharmaceutical spending per 1,000 Medicare beneficiaries for all drugs. The investigators also examined the relative contributions of Medicare Part D Plans’ payments, patients’ out-of-pocket costs, and other payments toward pharmaceutical spending.
Prices defied market expectations
The annual costs of treatment with self-administered DMTs for MS increased more than 300%. The mean annual cost was $18,660 in 2006 and $75,847 in 2016, and the mean annual rate of price increase was 12.8%. “Prices of most self-administered DMTs for MS increased in parallel, defying standard market expectations,” the investigators wrote.
Branded formulations of glatiramer acetate maintained the largest market share throughout the study period, ranging between 32.2% and 48.4%. However, the market share of platform therapies – glatiramer acetate, interferon beta-1a, and interferon beta-1b – decreased significantly from 2006 to 2016. Market shares for brand-name glatiramers declined from 36.7% to 32.2%, for intramuscular interferon beta-1a (30 mcg) from 32.3% to 14.2%, for interferon beta-1b from 18.7% to 4.5%, and for interferon beta-1a (8.8, 22, or 44 mcg) from 12.2% to 8.3%. The market shares of newer therapies, however, increased to 7.9% for fingolimod, 9.0% for teriflunomide, and 19.2% for dimethyl fumarate.
Pharmaceutical spending per 1,000 beneficiaries increased by a factor of 10.2 throughout the study period (from $7,794 to $79,411). Patients’ out-of-pocket spending per 1,000 beneficiaries increased by a factor of 7.2 (from $372 to $2,673). Furthermore, the relative contribution of federal payments toward pharmaceutical spending increased from 68.5% to 73.8%.
“Large increases in drug prices have not been specific to MS drugs,” said Dr. San-Juan-Rodriguez in an interview. “We previously described similar trends in other specialty medications used to treat severe disease states, such as tumor necrosis factor inhibitors [TNFi] for the treatment of rheumatoid arthritis. Yet these increases took place at a slower pace. For instance, list prices of TNFi increased at an average annual rate of 9.9% in the same time period, 2006-2016.
“It is important to acknowledge that rising list prices of drugs may partially reflect competition for rebates,” he added. “Yet the specific reasons behind the faster growth of prices of MS drugs, compared with the prices of drugs used in other disease states, remain uncertain.”
Neurologists should bear in mind that, although generic drugs are substantially cheaper than branded drugs, generic specialty medications do not always reduce costs for Medicare Part D beneficiaries. “On the contrary, due to incentive misalignments created by the Medicare Part D benefit design, beneficiaries using generic drugs such as Glatopa ... may pay more than those using the branded drug,” Dr. San-Juan-Rodriguez said.
What are neurologists’ responsibilities?
Although the original annual price of interferon beta-1b ($10,920) was stunning, physicians now recall it with nostalgia, wrote Daniel M. Hartung, PharmD, associate professor of biostatistics and epidemiology, and Dennis Bourdette, MD, professor of neurology, both at Oregon Health and Science University, Portland, in an accompanying editorial. “The prices for DMTs for MS have risen dramatically over the last 15 years, far outpacing inflation, and now have a mean price of more than $86,000 per year.”
Neurologists should be concerned about these rising prices, Dr. Hartung and Dr. Bourdette wrote. They should feel responsibility toward the health care system that pays for these medications, and toward patients who pay out of their own pockets. “Neurologists should be seeking to minimize the financial adverse effects of these therapies as much as they try to minimize physical adverse effects.”
One way for neurologists to address increasing prices is to urge state and federal lawmakers to pass legislation to curb them, they wrote. Neurologists also should reexamine their relationships with pharmaceutical and biotechnology companies. “Remaining silent should not be an option. ... Neurologists should not allow the unfettered increases in price for these drugs to hurt the health care system or patients.”
The Myers Family Foundation and the National Heart, Lung, and Blood Institute funded the research. Several authors are employees of health insurance companies such as the UPMC Health Plan Insurance Services Division and Humana. One author received personal fees from Pfizer that were unrelated to this study.
SOURCEs: San-Juan-Rodriguez A et al. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2711; Hartung DM and Bourdette D. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2445.
according to an analysis published in JAMA Neurology. The increased prices raise concern “because they demonstrate that the approval of new therapies did not ameliorate and could have even contributed to high inflation rates observed for incumbent drugs,” wrote the authors.
Four self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) were available before 2009, and seven new branded DMTs were introduced after that year. Previous research indicated that the prices of DMTs for MS increased at higher rates than the prices of drugs for other disorders. How these price increases affected pharmaceutical spending during the past decade is uncertain, however.
A review of Medicare claims data
Alvaro San-Juan-Rodriguez, PharmD, a fellow in pharmacoeconomics, outcomes, and pharmacoanalytics research at the University of Pittsburgh, and colleagues examined claims data from 2006 to 2016 from a 5% random sample of Medicare beneficiaries. Information for a mean of 2.8 million Medicare beneficiaries per year was available. The researchers extracted all prescription claims for self-administered DMTs for MS (that is, glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod, teriflunomide, dimethyl fumarate, and peginterferon beta-1a).
Dr. San-Juan-Rodriguez and associates chose three main outcomes. The first was the annual cost of treatment with each medication, which was based on Medicare Part D prescription claims gross costs and Food and Drug Administration–approved recommended dosing. The second was the market share of each medication, which the researchers defined as the proportion of pharmaceutical spending accounted for by each drug. The third was pharmaceutical spending per 1,000 Medicare beneficiaries for all drugs. The investigators also examined the relative contributions of Medicare Part D Plans’ payments, patients’ out-of-pocket costs, and other payments toward pharmaceutical spending.
Prices defied market expectations
The annual costs of treatment with self-administered DMTs for MS increased more than 300%. The mean annual cost was $18,660 in 2006 and $75,847 in 2016, and the mean annual rate of price increase was 12.8%. “Prices of most self-administered DMTs for MS increased in parallel, defying standard market expectations,” the investigators wrote.
Branded formulations of glatiramer acetate maintained the largest market share throughout the study period, ranging between 32.2% and 48.4%. However, the market share of platform therapies – glatiramer acetate, interferon beta-1a, and interferon beta-1b – decreased significantly from 2006 to 2016. Market shares for brand-name glatiramers declined from 36.7% to 32.2%, for intramuscular interferon beta-1a (30 mcg) from 32.3% to 14.2%, for interferon beta-1b from 18.7% to 4.5%, and for interferon beta-1a (8.8, 22, or 44 mcg) from 12.2% to 8.3%. The market shares of newer therapies, however, increased to 7.9% for fingolimod, 9.0% for teriflunomide, and 19.2% for dimethyl fumarate.
Pharmaceutical spending per 1,000 beneficiaries increased by a factor of 10.2 throughout the study period (from $7,794 to $79,411). Patients’ out-of-pocket spending per 1,000 beneficiaries increased by a factor of 7.2 (from $372 to $2,673). Furthermore, the relative contribution of federal payments toward pharmaceutical spending increased from 68.5% to 73.8%.
“Large increases in drug prices have not been specific to MS drugs,” said Dr. San-Juan-Rodriguez in an interview. “We previously described similar trends in other specialty medications used to treat severe disease states, such as tumor necrosis factor inhibitors [TNFi] for the treatment of rheumatoid arthritis. Yet these increases took place at a slower pace. For instance, list prices of TNFi increased at an average annual rate of 9.9% in the same time period, 2006-2016.
“It is important to acknowledge that rising list prices of drugs may partially reflect competition for rebates,” he added. “Yet the specific reasons behind the faster growth of prices of MS drugs, compared with the prices of drugs used in other disease states, remain uncertain.”
Neurologists should bear in mind that, although generic drugs are substantially cheaper than branded drugs, generic specialty medications do not always reduce costs for Medicare Part D beneficiaries. “On the contrary, due to incentive misalignments created by the Medicare Part D benefit design, beneficiaries using generic drugs such as Glatopa ... may pay more than those using the branded drug,” Dr. San-Juan-Rodriguez said.
What are neurologists’ responsibilities?
Although the original annual price of interferon beta-1b ($10,920) was stunning, physicians now recall it with nostalgia, wrote Daniel M. Hartung, PharmD, associate professor of biostatistics and epidemiology, and Dennis Bourdette, MD, professor of neurology, both at Oregon Health and Science University, Portland, in an accompanying editorial. “The prices for DMTs for MS have risen dramatically over the last 15 years, far outpacing inflation, and now have a mean price of more than $86,000 per year.”
Neurologists should be concerned about these rising prices, Dr. Hartung and Dr. Bourdette wrote. They should feel responsibility toward the health care system that pays for these medications, and toward patients who pay out of their own pockets. “Neurologists should be seeking to minimize the financial adverse effects of these therapies as much as they try to minimize physical adverse effects.”
One way for neurologists to address increasing prices is to urge state and federal lawmakers to pass legislation to curb them, they wrote. Neurologists also should reexamine their relationships with pharmaceutical and biotechnology companies. “Remaining silent should not be an option. ... Neurologists should not allow the unfettered increases in price for these drugs to hurt the health care system or patients.”
The Myers Family Foundation and the National Heart, Lung, and Blood Institute funded the research. Several authors are employees of health insurance companies such as the UPMC Health Plan Insurance Services Division and Humana. One author received personal fees from Pfizer that were unrelated to this study.
SOURCEs: San-Juan-Rodriguez A et al. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2711; Hartung DM and Bourdette D. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2445.
FROM JAMA NEUROLOGY
Dr. Roger McIntyre discusses the role of inflammation in mental illness
