User login
FDA grants priority review to polatuzumab vedotin for DLBCL
With this BLA, Genentech is seeking approval for polatuzumab vedotin in combination with bendamustine and rituximab (BR) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The FDA grants priority review to applications for products that are expected to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency aims to take action on a priority review application within 6 months, rather than the standard 10 months.
The FDA is expected to make a decision on this BLA by Aug. 19, 2019.
The BLA is supported by a phase 1b/2 trial (NCT02257567) of patients with relapsed or refractory follicular lymphoma or DLBCL who received polatuzumab vedotin in combination with BR or obinutuzumab.
The trial’s phase 2 stage included 80 DLBCL patients who were randomized to receive BR or BR plus polatuzumab vedotin, according to Genentech.
The complete response rate was 40% in the polatuzumab vedotin arm and 18% in the BR arm. The median duration of response was 10.3 months and 4.1 months, respectively (hazard ratio [HR] = 0.44).
The median progression-free survival was 7.6 months in the polatuzumab vedotin arm and 2.0 months in the BR arm (HR = 0.34).
Among patients who were ineligible for a transplant, the median overall survival (an exploratory endpoint) was 12.4 months in the polatuzumab vedotin arm and 4.7 months in the BR arm (HR = 0.42).
Patients who received polatuzumab vedotin had higher rates of grade 3-4 cytopenias, compared with patients who received BR alone. Rates of infection and transfusion were similar between the arms.
With this BLA, Genentech is seeking approval for polatuzumab vedotin in combination with bendamustine and rituximab (BR) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The FDA grants priority review to applications for products that are expected to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency aims to take action on a priority review application within 6 months, rather than the standard 10 months.
The FDA is expected to make a decision on this BLA by Aug. 19, 2019.
The BLA is supported by a phase 1b/2 trial (NCT02257567) of patients with relapsed or refractory follicular lymphoma or DLBCL who received polatuzumab vedotin in combination with BR or obinutuzumab.
The trial’s phase 2 stage included 80 DLBCL patients who were randomized to receive BR or BR plus polatuzumab vedotin, according to Genentech.
The complete response rate was 40% in the polatuzumab vedotin arm and 18% in the BR arm. The median duration of response was 10.3 months and 4.1 months, respectively (hazard ratio [HR] = 0.44).
The median progression-free survival was 7.6 months in the polatuzumab vedotin arm and 2.0 months in the BR arm (HR = 0.34).
Among patients who were ineligible for a transplant, the median overall survival (an exploratory endpoint) was 12.4 months in the polatuzumab vedotin arm and 4.7 months in the BR arm (HR = 0.42).
Patients who received polatuzumab vedotin had higher rates of grade 3-4 cytopenias, compared with patients who received BR alone. Rates of infection and transfusion were similar between the arms.
With this BLA, Genentech is seeking approval for polatuzumab vedotin in combination with bendamustine and rituximab (BR) to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The FDA grants priority review to applications for products that are expected to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The agency aims to take action on a priority review application within 6 months, rather than the standard 10 months.
The FDA is expected to make a decision on this BLA by Aug. 19, 2019.
The BLA is supported by a phase 1b/2 trial (NCT02257567) of patients with relapsed or refractory follicular lymphoma or DLBCL who received polatuzumab vedotin in combination with BR or obinutuzumab.
The trial’s phase 2 stage included 80 DLBCL patients who were randomized to receive BR or BR plus polatuzumab vedotin, according to Genentech.
The complete response rate was 40% in the polatuzumab vedotin arm and 18% in the BR arm. The median duration of response was 10.3 months and 4.1 months, respectively (hazard ratio [HR] = 0.44).
The median progression-free survival was 7.6 months in the polatuzumab vedotin arm and 2.0 months in the BR arm (HR = 0.34).
Among patients who were ineligible for a transplant, the median overall survival (an exploratory endpoint) was 12.4 months in the polatuzumab vedotin arm and 4.7 months in the BR arm (HR = 0.42).
Patients who received polatuzumab vedotin had higher rates of grade 3-4 cytopenias, compared with patients who received BR alone. Rates of infection and transfusion were similar between the arms.
Migraine and Conditioned Pain Modulation Efficiency
Migraine sufferers exhibited impaired conditioned pain modulation of the nociceptive blink reflex, suggesting a deficiency in inhibition of trigeminal nociception, which may contribute to the development of migraine headaches. This according to a recent study that aimed to assess conditioned pain modulation efficiency in persons with and without migraine headaches. Twenty-three adults with and 32 without a history of migraine headaches participated in the study. Four electrocutaneous stimulations of the supraorbital branch of the left trigeminal nerve were delivered at 150% of an individually determined pain threshold. Conditioned pain modulation was assessed by applying a noxious counterstimulus (forearm ischemia) and delivering 4 more electrocutaneous stimulations. After each stimulation, pain and the nociceptive blink reflex were assessed. Researchers found:
Participants with and without migraine headaches had similar baseline pain responsivity, without significant differences in pain report or nociceptive blink reflexes.
Pain report was inhibited by conditioned pain modulation in both the migraine and control groups.
However, unlike non-migraine controls, participants with migraines did not exhibit an inhibition of nociceptive blink reflexes during the ischemia task.
Williams AE, Miller MM, Bartley EJ, McCabe KM, Kerr KL, Rhudy JL. Impairment of inhibition of trigeminal nociception via conditioned pain modulation in persons with migraine headaches. [Published online ahead of print January 25, 2019]. Pain Med. doi:10.1093/pm/pny305.
Migraine sufferers exhibited impaired conditioned pain modulation of the nociceptive blink reflex, suggesting a deficiency in inhibition of trigeminal nociception, which may contribute to the development of migraine headaches. This according to a recent study that aimed to assess conditioned pain modulation efficiency in persons with and without migraine headaches. Twenty-three adults with and 32 without a history of migraine headaches participated in the study. Four electrocutaneous stimulations of the supraorbital branch of the left trigeminal nerve were delivered at 150% of an individually determined pain threshold. Conditioned pain modulation was assessed by applying a noxious counterstimulus (forearm ischemia) and delivering 4 more electrocutaneous stimulations. After each stimulation, pain and the nociceptive blink reflex were assessed. Researchers found:
Participants with and without migraine headaches had similar baseline pain responsivity, without significant differences in pain report or nociceptive blink reflexes.
Pain report was inhibited by conditioned pain modulation in both the migraine and control groups.
However, unlike non-migraine controls, participants with migraines did not exhibit an inhibition of nociceptive blink reflexes during the ischemia task.
Williams AE, Miller MM, Bartley EJ, McCabe KM, Kerr KL, Rhudy JL. Impairment of inhibition of trigeminal nociception via conditioned pain modulation in persons with migraine headaches. [Published online ahead of print January 25, 2019]. Pain Med. doi:10.1093/pm/pny305.
Migraine sufferers exhibited impaired conditioned pain modulation of the nociceptive blink reflex, suggesting a deficiency in inhibition of trigeminal nociception, which may contribute to the development of migraine headaches. This according to a recent study that aimed to assess conditioned pain modulation efficiency in persons with and without migraine headaches. Twenty-three adults with and 32 without a history of migraine headaches participated in the study. Four electrocutaneous stimulations of the supraorbital branch of the left trigeminal nerve were delivered at 150% of an individually determined pain threshold. Conditioned pain modulation was assessed by applying a noxious counterstimulus (forearm ischemia) and delivering 4 more electrocutaneous stimulations. After each stimulation, pain and the nociceptive blink reflex were assessed. Researchers found:
Participants with and without migraine headaches had similar baseline pain responsivity, without significant differences in pain report or nociceptive blink reflexes.
Pain report was inhibited by conditioned pain modulation in both the migraine and control groups.
However, unlike non-migraine controls, participants with migraines did not exhibit an inhibition of nociceptive blink reflexes during the ischemia task.
Williams AE, Miller MM, Bartley EJ, McCabe KM, Kerr KL, Rhudy JL. Impairment of inhibition of trigeminal nociception via conditioned pain modulation in persons with migraine headaches. [Published online ahead of print January 25, 2019]. Pain Med. doi:10.1093/pm/pny305.
Vestibular Migraine: Clinical Features and Triggers
Vestibular migraine (VM) typically affects women in their 40s with a personal and family history of migraine, according to a recent study. Typical ictal symptoms were triggered as well as spontaneous vertigo (associated with photophobia and phonophobia), nausea, aural symptoms, and headache. In addition, interictal vestibular symptoms, comorbid psychiatric disorders, and non‐specific interictal neuro‐otologic findings were common. Researchers evaluated a retrospective chart review of 491 patients seen from August 2014 until March 2018 at a tertiary neurology referral center for vestibular disorders to identify patients fulfilling the 2012 VM criteria. There were 131 patients (105 women) identified; mean age of VM onset was 44.3 (±13.7) years. They found:
Preceding the onset of vestibular symptoms, most had migraine (57.3%) and motion sickness (61.1%).
It was common to have a family history of migraine (50.8%) and episodic vestibular symptoms (28.1%).
Common ictal symptoms were triggered (visually induced and head‐motion) and spontaneous vertigo, accompanied by photophobia and phonophobia (118/131 [90.1%] patients), nausea (105/131 [80.2%] patients), aural symptoms (79/131 [60.3%] patients), and headache (65/131 [49.6%] patients).
Interictally, many experienced visually induced (116/131 [88.6%] patients), head‐motion (86/131 [65.6%] patients), and persistent (67/131 [51.1%] patients) dizziness.
Beh SC, Masrour S, Smith SV, Friedman DI. The spectrum of vestibular migraine: Clinical features, triggers, and examination findings. [Published online ahead of print February 8, 2019]. Headache. doi:10.1111/head.13484.
Vestibular migraine (VM) typically affects women in their 40s with a personal and family history of migraine, according to a recent study. Typical ictal symptoms were triggered as well as spontaneous vertigo (associated with photophobia and phonophobia), nausea, aural symptoms, and headache. In addition, interictal vestibular symptoms, comorbid psychiatric disorders, and non‐specific interictal neuro‐otologic findings were common. Researchers evaluated a retrospective chart review of 491 patients seen from August 2014 until March 2018 at a tertiary neurology referral center for vestibular disorders to identify patients fulfilling the 2012 VM criteria. There were 131 patients (105 women) identified; mean age of VM onset was 44.3 (±13.7) years. They found:
Preceding the onset of vestibular symptoms, most had migraine (57.3%) and motion sickness (61.1%).
It was common to have a family history of migraine (50.8%) and episodic vestibular symptoms (28.1%).
Common ictal symptoms were triggered (visually induced and head‐motion) and spontaneous vertigo, accompanied by photophobia and phonophobia (118/131 [90.1%] patients), nausea (105/131 [80.2%] patients), aural symptoms (79/131 [60.3%] patients), and headache (65/131 [49.6%] patients).
Interictally, many experienced visually induced (116/131 [88.6%] patients), head‐motion (86/131 [65.6%] patients), and persistent (67/131 [51.1%] patients) dizziness.
Beh SC, Masrour S, Smith SV, Friedman DI. The spectrum of vestibular migraine: Clinical features, triggers, and examination findings. [Published online ahead of print February 8, 2019]. Headache. doi:10.1111/head.13484.
Vestibular migraine (VM) typically affects women in their 40s with a personal and family history of migraine, according to a recent study. Typical ictal symptoms were triggered as well as spontaneous vertigo (associated with photophobia and phonophobia), nausea, aural symptoms, and headache. In addition, interictal vestibular symptoms, comorbid psychiatric disorders, and non‐specific interictal neuro‐otologic findings were common. Researchers evaluated a retrospective chart review of 491 patients seen from August 2014 until March 2018 at a tertiary neurology referral center for vestibular disorders to identify patients fulfilling the 2012 VM criteria. There were 131 patients (105 women) identified; mean age of VM onset was 44.3 (±13.7) years. They found:
Preceding the onset of vestibular symptoms, most had migraine (57.3%) and motion sickness (61.1%).
It was common to have a family history of migraine (50.8%) and episodic vestibular symptoms (28.1%).
Common ictal symptoms were triggered (visually induced and head‐motion) and spontaneous vertigo, accompanied by photophobia and phonophobia (118/131 [90.1%] patients), nausea (105/131 [80.2%] patients), aural symptoms (79/131 [60.3%] patients), and headache (65/131 [49.6%] patients).
Interictally, many experienced visually induced (116/131 [88.6%] patients), head‐motion (86/131 [65.6%] patients), and persistent (67/131 [51.1%] patients) dizziness.
Beh SC, Masrour S, Smith SV, Friedman DI. The spectrum of vestibular migraine: Clinical features, triggers, and examination findings. [Published online ahead of print February 8, 2019]. Headache. doi:10.1111/head.13484.
Complementary and alternative medicine
Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?
A. CAM practitioners are just as likely as medical doctors to be sued.
B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.
C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.
D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.
E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.
Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.
CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.
More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.
CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.
In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.
Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.
For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.
In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.1 In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.2
However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.3 The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.
The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.
Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.4 And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.5 The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.
Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.
In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.6 Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.
Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.
In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.7
The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.
In general, a physician may employ several legal defenses to avert liability following an adverse event.
One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.
A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.8 The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.
The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.
A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.
When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wengel v. Herfert, 473 N.W.2d 741 (1991).
2. Salazar v. Ehmann, 505 P.2d 387 (1972).
3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).
4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).
5. Wallman v. Kelley, 976 P.2d 330 (1998).
6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).
7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).
8. Schneider v. Revici, 817 F. 2d 987 (1987).
Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?
A. CAM practitioners are just as likely as medical doctors to be sued.
B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.
C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.
D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.
E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.
Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.
CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.
More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.
CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.
In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.
Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.
For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.
In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.1 In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.2
However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.3 The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.
The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.
Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.4 And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.5 The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.
Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.
In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.6 Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.
Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.
In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.7
The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.
In general, a physician may employ several legal defenses to avert liability following an adverse event.
One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.
A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.8 The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.
The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.
A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.
When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wengel v. Herfert, 473 N.W.2d 741 (1991).
2. Salazar v. Ehmann, 505 P.2d 387 (1972).
3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).
4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).
5. Wallman v. Kelley, 976 P.2d 330 (1998).
6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).
7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).
8. Schneider v. Revici, 817 F. 2d 987 (1987).
Question: Which one of the following statements regarding complementary and alternative medicine (CAM) is correct?
A. CAM practitioners are just as likely as medical doctors to be sued.
B. Damages arising out of the use of CAM may be compensable if there is clear and convincing evidence of substandard care, and the plaintiff can prove legal causation.
C. An acupuncturist who treats an asthmatic patient will be sued if he/she fails to refer the patient to a medical specialist.
D. Obtaining informed consent after discussing all therapeutic options and material risks is especially important for those who practice CAM.
E. It is not a valid defense that the patient had fully and willingly assumed the risk of treatment.
Answer: D. Compared with medical doctors, non-MD practitioners of CAM pay lower malpractice insurance premiums, as they are much less likely to be sued, and patient injuries are usually less severe.
CAM covers a broad range of healing philosophies, approaches, and therapies that are typically outside mainstream Western medicine. It comprises modalities such as chiropractic, acupuncture, massage therapy, naturopathic medicine, nutritional therapy, and others.
More than half of the U.S. population uses some form of CAM, which is widely perceived as a natural and effective means of promoting overall well being in addition to treating a specific illness. The scope of practice for CAM providers is defined and limited by state rather than federal statutes, and enforced by regulatory bodies.
CAM treatments are generally noninvasive, and there are fewer than 50 indemnity insurers in the country for chiropractors, massage therapists, and acupuncturists, underwriting some 5% of the total medical malpractice insurance market.
In the event of an injury, damages are recoverable if there is a preponderance of evidence to indicate substandard care. “Clear and convincing” is a higher evidentiary level of legal proof, and it is not required in a negligence action. Whether an acupuncturist will be sued successfully for treating an asthmatic patient will depend on many factors, for example, whether it is an acceptable CAM practice in the jurisdiction, whether there is any statutory restriction on such treatment, whether there was a failure of a timely referral, etc.
Finally, assumption of risk is a valid defense in a negligence tort action under some circumstances.
For a negligence claim to prevail, the plaintiff must establish breach of duty, i.e., that the defendant deviated from the standard of care ordinarily exercised by a similarly situated practitioner. In addition to falling below that level of skill, practitioners may also be sued for having failed to refer to a medical doctor, for practicing outside the scope of CAM, or for venturing into traditional Western medical practice.
In one instance, a plaintiff alleged that he was led to believe that chiropractic manipulation would help his diabetes. The court found in favor of the plaintiff and awarded damages.1 In another, the plaintiff successfully sued a chiropractor for failing to take x-rays and refer to a medical doctor. The court held that the defendant fell below the standard of care, as the state licensing board required physician referral when the problem extended beyond the limits of chiropractic practice.2
However, an injured party does not always prevail. In Miyamoto v. Lazo, the plaintiff claimed that Dr. Lazo, a chiropractor, negligently treated his injuries from a car accident.3 The patient was taking Coumadin and developed a hematoma in his left shoulder following chiropractic treatment. This was complicated by neuropathy in his left hand when the hematoma expanded and required surgical drainage.
The jury, however, found Dr. Lazo not liable, because of evidence that a hematoma could spontaneously arise in someone on an anticoagulant.
Injured patients have also filed lawsuits against other CAM practitioners. Allegations against acupuncturists have included cases of pneumothorax, wrongful death in an adolescent girl with asthma, and burns from a heat lamp.4 And in Wallman v. Kelley,a plaintiff developed liver damage and filed negligence and breach of implied warranty claims against a seller of Chinese herbal medicine.5 The court held that the defendant was not liable, as the plaintiff failed to prove causation or give timely notice of suit.
Medical doctors are increasingly incorporating CAM into their practices, so they must adhere to CAM standards in addition to their own medical standards.
In Charell v. Gonzalez, a cancer patient refused conventional treatment by oncologists and opted instead for nutritional therapy by a physician.6 Her cancer metastasized, and she alleged negligence and failure to warn of risks. The jury found the physician 51% liable for departure from standard of care and lack of informed consent. The plaintiff was found to be 49% at fault for choosing to ignore the recommendations of her oncologists.
Even if it’s the patient’s choice, physicians must still exercise due care when implementing therapy.
In Gonzalez v. New York State Department of Health, Dr. Gonzales was charged with gross negligence and incompetence after he used nutritional therapies to treat six patients with incurable cancer who had failed or rejected conventional treatment.7
The hearing committee found that he missed signs of disease progression and failed to perform adequate assessments, testing, and follow-up evaluations. The court held that a patient’s consent to or even insistence upon a certain treatment does not relieve the physician from the obligation of treating the patient with the usual standard of care.
In general, a physician may employ several legal defenses to avert liability following an adverse event.
One defense is to assert the “respectable minority” standard of care, if it can be shown that a respectable minority in the medical community also accepts the treatment in question.
A second defense is assumption of risk. In Schneider v. Revici, a physician delivered nutritional (selenium and dietary restrictions) and other nonsurgical treatment for breast cancer after the patient refused conventional treatments offered by other physicians.8 The patient signed a detailed consent form releasing the physician from liability and acknowledging that the defendant’s treatments lacked Food and Drug Administration approval, and that no results could be guaranteed.
The cancer spread, and the patient sued for common law fraud, medical malpractice, and lack of informed consent. The court of appeals held that assumption of risk is a complete defense to malpractice. The same court also held in another case that a patient’s failure to sign a consent form did not preclude the jury from considering the assumption of risk defense.
A third defense, rarely successful, is to invoke “clinical innovation” when CAM is used to alleviate a desperate situation, for example, if the patient is terminal or has failed conventional therapy. The defendant-physician may plead involvement in a clinical trial study, or show that the unorthodox treatment is based on extensive personal experience or some newly discovered developments in the field.
When discussing CAM, the physician should first fully inform the patient about conventional treatments and their limitations. Next, the physician should explain why the “novel” rather than the recognized conventional therapy is being considered. Finally, whether the physician intends to carry out CAM therapy or refer to another practitioner, the patient must be warned about the potential risks associated with such therapy.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is modified from a chapter in the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk.” It is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. Wengel v. Herfert, 473 N.W.2d 741 (1991).
2. Salazar v. Ehmann, 505 P.2d 387 (1972).
3. Miyamoto v. Lum and Lazo, 84 P.3d 509 (2004).
4. Rosenberg v. Jing Jiang, 153 A.D.3d 744 (2017).
5. Wallman v. Kelley, 976 P.2d 330 (1998).
6. Charell v. Gonzales, 673 N.Y.S. 2d 685 (1998).
7. Gonzales v. NYS DOH, 232 A.D.2d 886 (1996).
8. Schneider v. Revici, 817 F. 2d 987 (1987).
Antipsychotics show no link to increased risk of major congenital malformations
LAS VEGAS – Assessing the risk of major congenital malformations related to antipsychotic exposure requires detailed assessment of other sources of risk, including those related to the diagnosis and associated behaviors, according to Jonathan M. Meyer, MD.
However, the largest study to date showed no significant difference in rates of major congenital malformations for those with one or more prescriptions for atypical antipsychotics in the first trimester, compared with pregnancies with no first trimester antipsychotic exposure.
In the U.S. general population, the estimated risk of major birth defects is 2%-4%, Dr. Meyer, a clinical professor of psychiatry at the University of California, San Diego, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
Medications represent one source of risk for major congenital malformations in patients with psychiatric illness. Other factors include lifestyle factors such substance abuse and smoking, diet and physical activity, adherence with medical/prenatal care regimens, general medical disease burden, and unknown genetic risk because of the illness itself.
Until recently, published studies examining antipsychotic exposure and the risk for congenital malformations have been flawed because of numerous factors, Dr. Meyer said, including the small sample size of live births, absence of systematic collection of risk data prior to and during pregnancy, and failure to examine all possible covariates that might moderate the risk potentially attributable to the medication itself.
For example, researchers led by Frank Habermann, PhD, prospectively evaluated three cohorts who were followed in a psychiatry consultation in Freiburg, Germany: 453 women who received atypical antipsychotics in the first trimester of pregnancy (group A); 238 women who received typical antipsychotics in the first trimester of pregnancy (group B); and 1,104 women who had no records of treatment with medications associated with harmful fetal effects (group C).
Covariates included maternal age, alcohol consumption, smoking habits, number of previous spontaneous abortions, number of previous malformed children, and gestational week at delivery (J Clin Psychopharmacol. 2013;33[4]:453-62).
The researchers found that 5.2% of women in group A gave birth to a child with a major congenital malformation, compared with 5% in group B and 2.5% in group C. Nonsignificant associations were observed between group A vs. B (adjusted odds ratio, 1.26; 95% confidence interval, 0.57-2.82) and group B vs. C (adjusted OR, 1.71; 95% CI, 0.78-3.76). The only significant association noted was between group A and C (adjusted OR, 2.17; 95% CI, 1.20-3.91). However, Dr. Meyer emphasized limitations of the study, including its small sample size and certain missing covariates, including illegal substance use.
In addition, since subjects were enrolled in a consultation clinic, surveillance bias might have detected a higher number of CV malformations. “I don’t have a lot of confidence in this study because there were enormous sources of risk that were not controlled for,” said Dr. Meyer, who is also a psychopharmacology consultant for the California State Department of Hospitals.
In a separate study, researchers led by Lee S. Cohen, MD, assessed data from 487 women in the National Pregnancy Registry for Atypical Antipsychotics based at the Massachusetts General Hospital Center for Women’s Health, Boston. Of the 487 women, 353 were on atypical antipsychotics and 134 served as controls (Am J Psychiatry. 2016;73[3]:263-70). Medical records were obtained at baseline, month 7, and postpartum for 82% of subjects, which left 303 women in the final analysis. Covariates included demographic characteristics, medication use and dosage changes, social habits including smoking, use of alcohol and illicit drugs, medical and psychiatric history, and family history of birth defects.
Of 214 live births with first-trimester exposure to atypical antipsychotics, three major malformations were confirmed, while among the control group of 89 women, one major malformation was confirmed. The absolute risk of major malformations was 1.4% for exposed infants and 1.1% for unexposed infants. Meanwhile, the OR for major malformations comparing exposed infants was 1.25, which did not reach statistical significance (95% CI, 0.13-12.19). Limitations of the study include the small sample size of live births and the low overall rate of malformations, said Dr. Meyer. “This group of women living in the Boston area might not be representative of the general population based on the extremely low rates of congenital malformations for both cohorts in this study,” he commented.
In what Dr. Meyer said was the most robust study of its kind to date, researchers led by Krista F. Huybrechts, MS, PhD, drew from Medicaid data from 2000-2010 and included only women who were enrolled from 3 months before their last menstrual period through at least 1 month after delivery (JAMA Psychiatry. 2016;73[9]:938-46). The sample consisted of 1,341,715 pregnancies. Among those pregnancies, 9,258 women filled at least one prescription for an atypical antipsychotic, and 733 filled at least one prescription for a typical antipsychotic, for a total of 9,991 pregnancies. The researchers used propensity score matching to match for risk of antipsychotic exposure. They also balanced the antipsychotic-exposed and nonexposed groups for covariates that might be related to the outcome of interest (major congenital malformations), including (but not limited to) calendar year, age, race, smoking history, multiple gestation, indications for antipsychotic use, other maternal morbidity, concomitant medication use, and general markers of illness burden in the 3 months prior to pregnancy.
The atypical antipsychotics used included quetiapine (n = 4,221), followed by aripiprazole (n = 1,756), risperidone (n = 1,566), olanzapine (n = 1,394), and ziprasidone (n = 697). The absolute risks for congenital malformations per 1,000 live-born infants was 38.2 (95% CI, 26.6-54.7) for those treated with typicals and 44.5 (95% CI, 40.5-48.9) for those treated with atypicals versus 32.7 (95% CI, 32.4-33.0) for untreated women. In the fully adjusted analysis, the risk ratio was not statistically different for those exposed to atypical antipsychotics, compared with the control group, for malformations overall (relative risk, 1.05; 95% CI, 0.96-1.16) nor for cardiac malformations (RR, 1.06; 95% CI, 0.90-1.24). However, the risk remained elevated for risperidone for overall malformations (RR, 1.26; 1.02-1.56) and cardiac malformations (RR, 1.26; 95% CI, 0.88-1.81).
When Dr. Huybrechts and her colleagues redefined exposure as having filled two more prescriptions or having at least a 1-day supply in the first trimester, the results did not meaningfully change. However, the association appeared to strengthen somewhat for risperidone when filling two or more prescriptions (RR, 1.46 for any malformation; 95% CI, 1.01-2.10; RR, 1.87 for cardiac malformations; 95% CI, 1.09-3.19). The researchers observed no evidence of a dose-response relationship for any of the individual antipsychotics except risperidone. Risperidone dosages of 2 mg/day or more were associated with an increased risk for cardiac malformation (RR, 2.08; 95% CI, 1.32-3.28).
“The small increase in absolute risk and RR for malformations observed with risperidone should be interpreted with caution because no apparent biological mechanism can readily explain this outcome and the possibility of a chance finding cannot be ruled out,” the authors wrote in their study. “This finding should therefore be interpreted as a potential safety signal that will require follow-up in other studies.”
If the finding in this study is replicated, Dr. Meyer said, a number needed to harm analysis suggests that compared with no antipsychotic use. “Given the risks of bad outcomes that might occur related to medication switching or nonadherence, the risk-benefit ratio may tilt towards continuing risperidone, especially when a long-acting injectable [LAI] antipsychotic is needed in someone who responds to risperidone and either doesn’t respond to or tolerate the medications available in other LAI preparations such aripiprazole, haloperidol, or fluphenazine,” he said. “This need to balance the risks of exacerbating the mental disorder and the extremely small chance of an adverse pregnancy outcome is part of a clinical discussion one should have with the patient and her family.”
Dr. Meyer reported having received speaking or advising fees from Acadia, Alkermes, Allergan, Intracellular Therapies, Merck, Neurocrine, Otsuka America, Sunovion, and Teva.
LAS VEGAS – Assessing the risk of major congenital malformations related to antipsychotic exposure requires detailed assessment of other sources of risk, including those related to the diagnosis and associated behaviors, according to Jonathan M. Meyer, MD.
However, the largest study to date showed no significant difference in rates of major congenital malformations for those with one or more prescriptions for atypical antipsychotics in the first trimester, compared with pregnancies with no first trimester antipsychotic exposure.
In the U.S. general population, the estimated risk of major birth defects is 2%-4%, Dr. Meyer, a clinical professor of psychiatry at the University of California, San Diego, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
Medications represent one source of risk for major congenital malformations in patients with psychiatric illness. Other factors include lifestyle factors such substance abuse and smoking, diet and physical activity, adherence with medical/prenatal care regimens, general medical disease burden, and unknown genetic risk because of the illness itself.
Until recently, published studies examining antipsychotic exposure and the risk for congenital malformations have been flawed because of numerous factors, Dr. Meyer said, including the small sample size of live births, absence of systematic collection of risk data prior to and during pregnancy, and failure to examine all possible covariates that might moderate the risk potentially attributable to the medication itself.
For example, researchers led by Frank Habermann, PhD, prospectively evaluated three cohorts who were followed in a psychiatry consultation in Freiburg, Germany: 453 women who received atypical antipsychotics in the first trimester of pregnancy (group A); 238 women who received typical antipsychotics in the first trimester of pregnancy (group B); and 1,104 women who had no records of treatment with medications associated with harmful fetal effects (group C).
Covariates included maternal age, alcohol consumption, smoking habits, number of previous spontaneous abortions, number of previous malformed children, and gestational week at delivery (J Clin Psychopharmacol. 2013;33[4]:453-62).
The researchers found that 5.2% of women in group A gave birth to a child with a major congenital malformation, compared with 5% in group B and 2.5% in group C. Nonsignificant associations were observed between group A vs. B (adjusted odds ratio, 1.26; 95% confidence interval, 0.57-2.82) and group B vs. C (adjusted OR, 1.71; 95% CI, 0.78-3.76). The only significant association noted was between group A and C (adjusted OR, 2.17; 95% CI, 1.20-3.91). However, Dr. Meyer emphasized limitations of the study, including its small sample size and certain missing covariates, including illegal substance use.
In addition, since subjects were enrolled in a consultation clinic, surveillance bias might have detected a higher number of CV malformations. “I don’t have a lot of confidence in this study because there were enormous sources of risk that were not controlled for,” said Dr. Meyer, who is also a psychopharmacology consultant for the California State Department of Hospitals.
In a separate study, researchers led by Lee S. Cohen, MD, assessed data from 487 women in the National Pregnancy Registry for Atypical Antipsychotics based at the Massachusetts General Hospital Center for Women’s Health, Boston. Of the 487 women, 353 were on atypical antipsychotics and 134 served as controls (Am J Psychiatry. 2016;73[3]:263-70). Medical records were obtained at baseline, month 7, and postpartum for 82% of subjects, which left 303 women in the final analysis. Covariates included demographic characteristics, medication use and dosage changes, social habits including smoking, use of alcohol and illicit drugs, medical and psychiatric history, and family history of birth defects.
Of 214 live births with first-trimester exposure to atypical antipsychotics, three major malformations were confirmed, while among the control group of 89 women, one major malformation was confirmed. The absolute risk of major malformations was 1.4% for exposed infants and 1.1% for unexposed infants. Meanwhile, the OR for major malformations comparing exposed infants was 1.25, which did not reach statistical significance (95% CI, 0.13-12.19). Limitations of the study include the small sample size of live births and the low overall rate of malformations, said Dr. Meyer. “This group of women living in the Boston area might not be representative of the general population based on the extremely low rates of congenital malformations for both cohorts in this study,” he commented.
In what Dr. Meyer said was the most robust study of its kind to date, researchers led by Krista F. Huybrechts, MS, PhD, drew from Medicaid data from 2000-2010 and included only women who were enrolled from 3 months before their last menstrual period through at least 1 month after delivery (JAMA Psychiatry. 2016;73[9]:938-46). The sample consisted of 1,341,715 pregnancies. Among those pregnancies, 9,258 women filled at least one prescription for an atypical antipsychotic, and 733 filled at least one prescription for a typical antipsychotic, for a total of 9,991 pregnancies. The researchers used propensity score matching to match for risk of antipsychotic exposure. They also balanced the antipsychotic-exposed and nonexposed groups for covariates that might be related to the outcome of interest (major congenital malformations), including (but not limited to) calendar year, age, race, smoking history, multiple gestation, indications for antipsychotic use, other maternal morbidity, concomitant medication use, and general markers of illness burden in the 3 months prior to pregnancy.
The atypical antipsychotics used included quetiapine (n = 4,221), followed by aripiprazole (n = 1,756), risperidone (n = 1,566), olanzapine (n = 1,394), and ziprasidone (n = 697). The absolute risks for congenital malformations per 1,000 live-born infants was 38.2 (95% CI, 26.6-54.7) for those treated with typicals and 44.5 (95% CI, 40.5-48.9) for those treated with atypicals versus 32.7 (95% CI, 32.4-33.0) for untreated women. In the fully adjusted analysis, the risk ratio was not statistically different for those exposed to atypical antipsychotics, compared with the control group, for malformations overall (relative risk, 1.05; 95% CI, 0.96-1.16) nor for cardiac malformations (RR, 1.06; 95% CI, 0.90-1.24). However, the risk remained elevated for risperidone for overall malformations (RR, 1.26; 1.02-1.56) and cardiac malformations (RR, 1.26; 95% CI, 0.88-1.81).
When Dr. Huybrechts and her colleagues redefined exposure as having filled two more prescriptions or having at least a 1-day supply in the first trimester, the results did not meaningfully change. However, the association appeared to strengthen somewhat for risperidone when filling two or more prescriptions (RR, 1.46 for any malformation; 95% CI, 1.01-2.10; RR, 1.87 for cardiac malformations; 95% CI, 1.09-3.19). The researchers observed no evidence of a dose-response relationship for any of the individual antipsychotics except risperidone. Risperidone dosages of 2 mg/day or more were associated with an increased risk for cardiac malformation (RR, 2.08; 95% CI, 1.32-3.28).
“The small increase in absolute risk and RR for malformations observed with risperidone should be interpreted with caution because no apparent biological mechanism can readily explain this outcome and the possibility of a chance finding cannot be ruled out,” the authors wrote in their study. “This finding should therefore be interpreted as a potential safety signal that will require follow-up in other studies.”
If the finding in this study is replicated, Dr. Meyer said, a number needed to harm analysis suggests that compared with no antipsychotic use. “Given the risks of bad outcomes that might occur related to medication switching or nonadherence, the risk-benefit ratio may tilt towards continuing risperidone, especially when a long-acting injectable [LAI] antipsychotic is needed in someone who responds to risperidone and either doesn’t respond to or tolerate the medications available in other LAI preparations such aripiprazole, haloperidol, or fluphenazine,” he said. “This need to balance the risks of exacerbating the mental disorder and the extremely small chance of an adverse pregnancy outcome is part of a clinical discussion one should have with the patient and her family.”
Dr. Meyer reported having received speaking or advising fees from Acadia, Alkermes, Allergan, Intracellular Therapies, Merck, Neurocrine, Otsuka America, Sunovion, and Teva.
LAS VEGAS – Assessing the risk of major congenital malformations related to antipsychotic exposure requires detailed assessment of other sources of risk, including those related to the diagnosis and associated behaviors, according to Jonathan M. Meyer, MD.
However, the largest study to date showed no significant difference in rates of major congenital malformations for those with one or more prescriptions for atypical antipsychotics in the first trimester, compared with pregnancies with no first trimester antipsychotic exposure.
In the U.S. general population, the estimated risk of major birth defects is 2%-4%, Dr. Meyer, a clinical professor of psychiatry at the University of California, San Diego, said at an annual psychopharmacology update held by the Nevada Psychiatric Association.
Medications represent one source of risk for major congenital malformations in patients with psychiatric illness. Other factors include lifestyle factors such substance abuse and smoking, diet and physical activity, adherence with medical/prenatal care regimens, general medical disease burden, and unknown genetic risk because of the illness itself.
Until recently, published studies examining antipsychotic exposure and the risk for congenital malformations have been flawed because of numerous factors, Dr. Meyer said, including the small sample size of live births, absence of systematic collection of risk data prior to and during pregnancy, and failure to examine all possible covariates that might moderate the risk potentially attributable to the medication itself.
For example, researchers led by Frank Habermann, PhD, prospectively evaluated three cohorts who were followed in a psychiatry consultation in Freiburg, Germany: 453 women who received atypical antipsychotics in the first trimester of pregnancy (group A); 238 women who received typical antipsychotics in the first trimester of pregnancy (group B); and 1,104 women who had no records of treatment with medications associated with harmful fetal effects (group C).
Covariates included maternal age, alcohol consumption, smoking habits, number of previous spontaneous abortions, number of previous malformed children, and gestational week at delivery (J Clin Psychopharmacol. 2013;33[4]:453-62).
The researchers found that 5.2% of women in group A gave birth to a child with a major congenital malformation, compared with 5% in group B and 2.5% in group C. Nonsignificant associations were observed between group A vs. B (adjusted odds ratio, 1.26; 95% confidence interval, 0.57-2.82) and group B vs. C (adjusted OR, 1.71; 95% CI, 0.78-3.76). The only significant association noted was between group A and C (adjusted OR, 2.17; 95% CI, 1.20-3.91). However, Dr. Meyer emphasized limitations of the study, including its small sample size and certain missing covariates, including illegal substance use.
In addition, since subjects were enrolled in a consultation clinic, surveillance bias might have detected a higher number of CV malformations. “I don’t have a lot of confidence in this study because there were enormous sources of risk that were not controlled for,” said Dr. Meyer, who is also a psychopharmacology consultant for the California State Department of Hospitals.
In a separate study, researchers led by Lee S. Cohen, MD, assessed data from 487 women in the National Pregnancy Registry for Atypical Antipsychotics based at the Massachusetts General Hospital Center for Women’s Health, Boston. Of the 487 women, 353 were on atypical antipsychotics and 134 served as controls (Am J Psychiatry. 2016;73[3]:263-70). Medical records were obtained at baseline, month 7, and postpartum for 82% of subjects, which left 303 women in the final analysis. Covariates included demographic characteristics, medication use and dosage changes, social habits including smoking, use of alcohol and illicit drugs, medical and psychiatric history, and family history of birth defects.
Of 214 live births with first-trimester exposure to atypical antipsychotics, three major malformations were confirmed, while among the control group of 89 women, one major malformation was confirmed. The absolute risk of major malformations was 1.4% for exposed infants and 1.1% for unexposed infants. Meanwhile, the OR for major malformations comparing exposed infants was 1.25, which did not reach statistical significance (95% CI, 0.13-12.19). Limitations of the study include the small sample size of live births and the low overall rate of malformations, said Dr. Meyer. “This group of women living in the Boston area might not be representative of the general population based on the extremely low rates of congenital malformations for both cohorts in this study,” he commented.
In what Dr. Meyer said was the most robust study of its kind to date, researchers led by Krista F. Huybrechts, MS, PhD, drew from Medicaid data from 2000-2010 and included only women who were enrolled from 3 months before their last menstrual period through at least 1 month after delivery (JAMA Psychiatry. 2016;73[9]:938-46). The sample consisted of 1,341,715 pregnancies. Among those pregnancies, 9,258 women filled at least one prescription for an atypical antipsychotic, and 733 filled at least one prescription for a typical antipsychotic, for a total of 9,991 pregnancies. The researchers used propensity score matching to match for risk of antipsychotic exposure. They also balanced the antipsychotic-exposed and nonexposed groups for covariates that might be related to the outcome of interest (major congenital malformations), including (but not limited to) calendar year, age, race, smoking history, multiple gestation, indications for antipsychotic use, other maternal morbidity, concomitant medication use, and general markers of illness burden in the 3 months prior to pregnancy.
The atypical antipsychotics used included quetiapine (n = 4,221), followed by aripiprazole (n = 1,756), risperidone (n = 1,566), olanzapine (n = 1,394), and ziprasidone (n = 697). The absolute risks for congenital malformations per 1,000 live-born infants was 38.2 (95% CI, 26.6-54.7) for those treated with typicals and 44.5 (95% CI, 40.5-48.9) for those treated with atypicals versus 32.7 (95% CI, 32.4-33.0) for untreated women. In the fully adjusted analysis, the risk ratio was not statistically different for those exposed to atypical antipsychotics, compared with the control group, for malformations overall (relative risk, 1.05; 95% CI, 0.96-1.16) nor for cardiac malformations (RR, 1.06; 95% CI, 0.90-1.24). However, the risk remained elevated for risperidone for overall malformations (RR, 1.26; 1.02-1.56) and cardiac malformations (RR, 1.26; 95% CI, 0.88-1.81).
When Dr. Huybrechts and her colleagues redefined exposure as having filled two more prescriptions or having at least a 1-day supply in the first trimester, the results did not meaningfully change. However, the association appeared to strengthen somewhat for risperidone when filling two or more prescriptions (RR, 1.46 for any malformation; 95% CI, 1.01-2.10; RR, 1.87 for cardiac malformations; 95% CI, 1.09-3.19). The researchers observed no evidence of a dose-response relationship for any of the individual antipsychotics except risperidone. Risperidone dosages of 2 mg/day or more were associated with an increased risk for cardiac malformation (RR, 2.08; 95% CI, 1.32-3.28).
“The small increase in absolute risk and RR for malformations observed with risperidone should be interpreted with caution because no apparent biological mechanism can readily explain this outcome and the possibility of a chance finding cannot be ruled out,” the authors wrote in their study. “This finding should therefore be interpreted as a potential safety signal that will require follow-up in other studies.”
If the finding in this study is replicated, Dr. Meyer said, a number needed to harm analysis suggests that compared with no antipsychotic use. “Given the risks of bad outcomes that might occur related to medication switching or nonadherence, the risk-benefit ratio may tilt towards continuing risperidone, especially when a long-acting injectable [LAI] antipsychotic is needed in someone who responds to risperidone and either doesn’t respond to or tolerate the medications available in other LAI preparations such aripiprazole, haloperidol, or fluphenazine,” he said. “This need to balance the risks of exacerbating the mental disorder and the extremely small chance of an adverse pregnancy outcome is part of a clinical discussion one should have with the patient and her family.”
Dr. Meyer reported having received speaking or advising fees from Acadia, Alkermes, Allergan, Intracellular Therapies, Merck, Neurocrine, Otsuka America, Sunovion, and Teva.
EXPERT ANALYSIS FROM NPA 2019
Dr. Lisa Christopher-Stine: Polymyositis? It’s more likely something else
“When someone refers you [a patient with suspected] polymyositis, I want you to do a checklist in your head and say, ‘Have I thought about these five things?’ ” Dr. Christopher-Stine, director of the Johns Hopkins Myositis Center, Baltimore, said at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
The five most common diagnoses in patients labeled as having polymyositis are immune-mediated necrotizing myopathy (IMNM), overlap with other rheumatologic conditions, antisynthetase syndrome, inclusion body myositis (IBM), and muscular dystrophy, she explained.
“You may say, ‘look, it’s all what you call it,’ but I think we need to be a little bit more careful in what we call it,” she said.
IMNM
Patients with IMNM present with clinical symptoms similar to those seen in polymyositis and dermatomyositis – mainly proximal muscle weakness.
However, there are some important differences, both clinically and histologically, Dr. Christopher-Stine said.
“Look for higher [creatine kinase (CK)] levels,” she said. “In the thousands, usually multiple thousands ... like 5,000, 10,000, 2,000 ... that’s when you’re thinking about a necrotizing phenotype before you even look at the biopsy.”
CK levels will usually be under 30,000 U/L in IMNM, she noted, adding that data increasingly suggest that the extensive muscle necrosis in IMNM explains the elevated CK levels versus those seen in other myopathies.
Myalgias also tend to be more prominent in IMNM than in polymyositis.
“These folks hurt,” she said, noting that IMNM patients tend to have more extensive muscle atrophy and functional disability. “Many will be wheelchair bound within 9 months of diagnosis; it’s not subtle.”
The most important tool for making an IMNM diagnosis is muscle biopsy; look for prominent myocyte necrosis and a relative paucity of lymphocytes, she advised.
Overlap
Sometimes patients with polymyositis also have other rheumatologic conditions that shouldn’t be overlooked, therefore “overlap is its own category,” she said.
“In our experience, the most common overlap is scleroderma,” she noted, adding that the scleroderma is often, but not always, subtle, and that there may be overlapping autoantibodies.
Overt sclerodactyly is rarely seen, although a small amount may be present, but significant Raynaud’s phenomenon is common in these patients, and tiny telangiectasias across the neck are a tell-tale sign.
“Why does that matter? It’s not an esoteric argument; those are the folks that go on to have pulmonary hypertension,” she said. “They can have the same [interstitial lung disease] and all of the other internal scleroderma manifestations.”
Think about overlap and “look close phenotypically and with antibodies,” she advised.
There is also “the typical RA seropositive overlap,” she said, but lupus only rarely overlaps with myositis.
“However, the next diagnosis on the list – antisynthetase syndrome – can be a forme fruste where you first see a seronegative RA-like picture, and it’s important to think about that as well,” she said.
Antisynthetase syndrome
In patients referred for polymyositis, it’s also important to evaluate for antisynthetase syndrome, Dr. Christopher-Stine said.
The arthritis seen in the extramuscular phenotype of the syndrome is rarely deforming, but despite what many physicians were taught, “it absolutely can be erosive,” she said.
In fact, 40% of people with this syndrome present with an isolated forme fruste seronegative rheumatoid arthritis, she said.
Roughening and desquamation of the skin on the radial surface of fingers or palms – a sign known as mechanic’s hands – that doesn’t have another identifiable cause suggests this diagnosis in patients with this type of arthritis, as does interstitial lung disease and Raynaud’s phenomenon.
The Raynaud’s can be “fairly significant in the sense that it is bothersome,” but it usually doesn’t lead to ulceration or digital necrosis.
This is different from what is seen with the scleroderma phenotype, she said, adding that “if you’re starting to see gangrene and digital loss, think of something else.”
IBM
IBM is “probably the No. 1 most-missed diagnosis” among patients referred for what is initially believed to be polymyositis, Dr. Christopher-Stine said.
“I used to think that this was missed at entry, that everybody [with IBM] had all of these criteria and that rheumatologists really didn’t understand this phenotype ... but some people morph into this,” she said, explaining that they often start out looking like they have polymyositis with proximal muscle weakness.
“They may even initially respond to steroids. And then they get this phenotype,” she said.
Older men are more likely to present with the phenotype from the beginning; women, in her experience, tend to present with what appears to be polymyositis, and then develop the phenotype over time, she noted.
An IBM diagnosis requires age over 30 years, but most patients are over 50, she said.
“This is the only one of the myopathies that is preferential to men,” she added, noting that it affects men twice as often as it does women.
The syndrome is characterized by proximal strength loss and muscle atrophy. Also, a finding that a patient’s knee extensors are weaker than their hip flexors is “a fantastic bedside sign” differentiating IBM from polymyositis, she said.
That’s not to say IBM patients don’t have hip flexor weakness, but their knee extensors usually are “considerably weaker by a grade strength or more” versus their hip flexors, she explained.
“It’s a very easy bedside test. In typical other myopathies we have this, but the knee extensors aren’t that weak in general, or they’re not as weak as the hip flexors,” she added.
Another sign is distal strength loss, particularly in the forearm and finger flexors.
“I was taught to have them make a fist; don’t have them make a fist,” she said, explaining that this recruits intrinsic muscles which basically allows cheating that may mask weakness.
Instead, ask them to flex just their distal interphalangeal joints by making a claw and using the fingers to pull against your fingers, she suggested.
Mixed myopathic and neuropathic features on electromyography also indicate IBM, she said.
Muscle biopsy may be helpful, but inclusions are seen in less than one-third of IBM patients.
“At times, we have had to biopsy three times to see them at all, and some people never show them, so you have to rely on your clinical acumen if you don’t see them,” she said.
Also, keep in mind that these patients are often labeled as having treatment-resistant polymyositis.
“Please, when somebody refers to you somebody that’s treatment resistant, that may be the case, but I want you to think maybe they’re treatment resistant because they don’t have that disease.”
Muscular dystrophy
Some cases of myositis mimic certain types of muscular dystrophy, Dr. Christopher-Stine said, providing a checklist of muscular dystrophies that can look “clinically completely indistinguishable from a typical inflammatory myopathy,” and should therefore be considered in these patients.
The checklist includes Duchenne’s manifesting carrier, limb girdle muscular dystrophy type 2b, myotonic dystrophy (usually type 2), and facioscapulohumeral muscular dystrophy.
Dr. Christopher-Stine reported having intellectual property interest in a novel Inova Diagnostics autoantibody assay detection for anti-HMGCR. She was also the safety officer for the JBT-101 Trial sponsored by Corbus and funded by the National Institutes of Health.
“When someone refers you [a patient with suspected] polymyositis, I want you to do a checklist in your head and say, ‘Have I thought about these five things?’ ” Dr. Christopher-Stine, director of the Johns Hopkins Myositis Center, Baltimore, said at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
The five most common diagnoses in patients labeled as having polymyositis are immune-mediated necrotizing myopathy (IMNM), overlap with other rheumatologic conditions, antisynthetase syndrome, inclusion body myositis (IBM), and muscular dystrophy, she explained.
“You may say, ‘look, it’s all what you call it,’ but I think we need to be a little bit more careful in what we call it,” she said.
IMNM
Patients with IMNM present with clinical symptoms similar to those seen in polymyositis and dermatomyositis – mainly proximal muscle weakness.
However, there are some important differences, both clinically and histologically, Dr. Christopher-Stine said.
“Look for higher [creatine kinase (CK)] levels,” she said. “In the thousands, usually multiple thousands ... like 5,000, 10,000, 2,000 ... that’s when you’re thinking about a necrotizing phenotype before you even look at the biopsy.”
CK levels will usually be under 30,000 U/L in IMNM, she noted, adding that data increasingly suggest that the extensive muscle necrosis in IMNM explains the elevated CK levels versus those seen in other myopathies.
Myalgias also tend to be more prominent in IMNM than in polymyositis.
“These folks hurt,” she said, noting that IMNM patients tend to have more extensive muscle atrophy and functional disability. “Many will be wheelchair bound within 9 months of diagnosis; it’s not subtle.”
The most important tool for making an IMNM diagnosis is muscle biopsy; look for prominent myocyte necrosis and a relative paucity of lymphocytes, she advised.
Overlap
Sometimes patients with polymyositis also have other rheumatologic conditions that shouldn’t be overlooked, therefore “overlap is its own category,” she said.
“In our experience, the most common overlap is scleroderma,” she noted, adding that the scleroderma is often, but not always, subtle, and that there may be overlapping autoantibodies.
Overt sclerodactyly is rarely seen, although a small amount may be present, but significant Raynaud’s phenomenon is common in these patients, and tiny telangiectasias across the neck are a tell-tale sign.
“Why does that matter? It’s not an esoteric argument; those are the folks that go on to have pulmonary hypertension,” she said. “They can have the same [interstitial lung disease] and all of the other internal scleroderma manifestations.”
Think about overlap and “look close phenotypically and with antibodies,” she advised.
There is also “the typical RA seropositive overlap,” she said, but lupus only rarely overlaps with myositis.
“However, the next diagnosis on the list – antisynthetase syndrome – can be a forme fruste where you first see a seronegative RA-like picture, and it’s important to think about that as well,” she said.
Antisynthetase syndrome
In patients referred for polymyositis, it’s also important to evaluate for antisynthetase syndrome, Dr. Christopher-Stine said.
The arthritis seen in the extramuscular phenotype of the syndrome is rarely deforming, but despite what many physicians were taught, “it absolutely can be erosive,” she said.
In fact, 40% of people with this syndrome present with an isolated forme fruste seronegative rheumatoid arthritis, she said.
Roughening and desquamation of the skin on the radial surface of fingers or palms – a sign known as mechanic’s hands – that doesn’t have another identifiable cause suggests this diagnosis in patients with this type of arthritis, as does interstitial lung disease and Raynaud’s phenomenon.
The Raynaud’s can be “fairly significant in the sense that it is bothersome,” but it usually doesn’t lead to ulceration or digital necrosis.
This is different from what is seen with the scleroderma phenotype, she said, adding that “if you’re starting to see gangrene and digital loss, think of something else.”
IBM
IBM is “probably the No. 1 most-missed diagnosis” among patients referred for what is initially believed to be polymyositis, Dr. Christopher-Stine said.
“I used to think that this was missed at entry, that everybody [with IBM] had all of these criteria and that rheumatologists really didn’t understand this phenotype ... but some people morph into this,” she said, explaining that they often start out looking like they have polymyositis with proximal muscle weakness.
“They may even initially respond to steroids. And then they get this phenotype,” she said.
Older men are more likely to present with the phenotype from the beginning; women, in her experience, tend to present with what appears to be polymyositis, and then develop the phenotype over time, she noted.
An IBM diagnosis requires age over 30 years, but most patients are over 50, she said.
“This is the only one of the myopathies that is preferential to men,” she added, noting that it affects men twice as often as it does women.
The syndrome is characterized by proximal strength loss and muscle atrophy. Also, a finding that a patient’s knee extensors are weaker than their hip flexors is “a fantastic bedside sign” differentiating IBM from polymyositis, she said.
That’s not to say IBM patients don’t have hip flexor weakness, but their knee extensors usually are “considerably weaker by a grade strength or more” versus their hip flexors, she explained.
“It’s a very easy bedside test. In typical other myopathies we have this, but the knee extensors aren’t that weak in general, or they’re not as weak as the hip flexors,” she added.
Another sign is distal strength loss, particularly in the forearm and finger flexors.
“I was taught to have them make a fist; don’t have them make a fist,” she said, explaining that this recruits intrinsic muscles which basically allows cheating that may mask weakness.
Instead, ask them to flex just their distal interphalangeal joints by making a claw and using the fingers to pull against your fingers, she suggested.
Mixed myopathic and neuropathic features on electromyography also indicate IBM, she said.
Muscle biopsy may be helpful, but inclusions are seen in less than one-third of IBM patients.
“At times, we have had to biopsy three times to see them at all, and some people never show them, so you have to rely on your clinical acumen if you don’t see them,” she said.
Also, keep in mind that these patients are often labeled as having treatment-resistant polymyositis.
“Please, when somebody refers to you somebody that’s treatment resistant, that may be the case, but I want you to think maybe they’re treatment resistant because they don’t have that disease.”
Muscular dystrophy
Some cases of myositis mimic certain types of muscular dystrophy, Dr. Christopher-Stine said, providing a checklist of muscular dystrophies that can look “clinically completely indistinguishable from a typical inflammatory myopathy,” and should therefore be considered in these patients.
The checklist includes Duchenne’s manifesting carrier, limb girdle muscular dystrophy type 2b, myotonic dystrophy (usually type 2), and facioscapulohumeral muscular dystrophy.
Dr. Christopher-Stine reported having intellectual property interest in a novel Inova Diagnostics autoantibody assay detection for anti-HMGCR. She was also the safety officer for the JBT-101 Trial sponsored by Corbus and funded by the National Institutes of Health.
“When someone refers you [a patient with suspected] polymyositis, I want you to do a checklist in your head and say, ‘Have I thought about these five things?’ ” Dr. Christopher-Stine, director of the Johns Hopkins Myositis Center, Baltimore, said at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
The five most common diagnoses in patients labeled as having polymyositis are immune-mediated necrotizing myopathy (IMNM), overlap with other rheumatologic conditions, antisynthetase syndrome, inclusion body myositis (IBM), and muscular dystrophy, she explained.
“You may say, ‘look, it’s all what you call it,’ but I think we need to be a little bit more careful in what we call it,” she said.
IMNM
Patients with IMNM present with clinical symptoms similar to those seen in polymyositis and dermatomyositis – mainly proximal muscle weakness.
However, there are some important differences, both clinically and histologically, Dr. Christopher-Stine said.
“Look for higher [creatine kinase (CK)] levels,” she said. “In the thousands, usually multiple thousands ... like 5,000, 10,000, 2,000 ... that’s when you’re thinking about a necrotizing phenotype before you even look at the biopsy.”
CK levels will usually be under 30,000 U/L in IMNM, she noted, adding that data increasingly suggest that the extensive muscle necrosis in IMNM explains the elevated CK levels versus those seen in other myopathies.
Myalgias also tend to be more prominent in IMNM than in polymyositis.
“These folks hurt,” she said, noting that IMNM patients tend to have more extensive muscle atrophy and functional disability. “Many will be wheelchair bound within 9 months of diagnosis; it’s not subtle.”
The most important tool for making an IMNM diagnosis is muscle biopsy; look for prominent myocyte necrosis and a relative paucity of lymphocytes, she advised.
Overlap
Sometimes patients with polymyositis also have other rheumatologic conditions that shouldn’t be overlooked, therefore “overlap is its own category,” she said.
“In our experience, the most common overlap is scleroderma,” she noted, adding that the scleroderma is often, but not always, subtle, and that there may be overlapping autoantibodies.
Overt sclerodactyly is rarely seen, although a small amount may be present, but significant Raynaud’s phenomenon is common in these patients, and tiny telangiectasias across the neck are a tell-tale sign.
“Why does that matter? It’s not an esoteric argument; those are the folks that go on to have pulmonary hypertension,” she said. “They can have the same [interstitial lung disease] and all of the other internal scleroderma manifestations.”
Think about overlap and “look close phenotypically and with antibodies,” she advised.
There is also “the typical RA seropositive overlap,” she said, but lupus only rarely overlaps with myositis.
“However, the next diagnosis on the list – antisynthetase syndrome – can be a forme fruste where you first see a seronegative RA-like picture, and it’s important to think about that as well,” she said.
Antisynthetase syndrome
In patients referred for polymyositis, it’s also important to evaluate for antisynthetase syndrome, Dr. Christopher-Stine said.
The arthritis seen in the extramuscular phenotype of the syndrome is rarely deforming, but despite what many physicians were taught, “it absolutely can be erosive,” she said.
In fact, 40% of people with this syndrome present with an isolated forme fruste seronegative rheumatoid arthritis, she said.
Roughening and desquamation of the skin on the radial surface of fingers or palms – a sign known as mechanic’s hands – that doesn’t have another identifiable cause suggests this diagnosis in patients with this type of arthritis, as does interstitial lung disease and Raynaud’s phenomenon.
The Raynaud’s can be “fairly significant in the sense that it is bothersome,” but it usually doesn’t lead to ulceration or digital necrosis.
This is different from what is seen with the scleroderma phenotype, she said, adding that “if you’re starting to see gangrene and digital loss, think of something else.”
IBM
IBM is “probably the No. 1 most-missed diagnosis” among patients referred for what is initially believed to be polymyositis, Dr. Christopher-Stine said.
“I used to think that this was missed at entry, that everybody [with IBM] had all of these criteria and that rheumatologists really didn’t understand this phenotype ... but some people morph into this,” she said, explaining that they often start out looking like they have polymyositis with proximal muscle weakness.
“They may even initially respond to steroids. And then they get this phenotype,” she said.
Older men are more likely to present with the phenotype from the beginning; women, in her experience, tend to present with what appears to be polymyositis, and then develop the phenotype over time, she noted.
An IBM diagnosis requires age over 30 years, but most patients are over 50, she said.
“This is the only one of the myopathies that is preferential to men,” she added, noting that it affects men twice as often as it does women.
The syndrome is characterized by proximal strength loss and muscle atrophy. Also, a finding that a patient’s knee extensors are weaker than their hip flexors is “a fantastic bedside sign” differentiating IBM from polymyositis, she said.
That’s not to say IBM patients don’t have hip flexor weakness, but their knee extensors usually are “considerably weaker by a grade strength or more” versus their hip flexors, she explained.
“It’s a very easy bedside test. In typical other myopathies we have this, but the knee extensors aren’t that weak in general, or they’re not as weak as the hip flexors,” she added.
Another sign is distal strength loss, particularly in the forearm and finger flexors.
“I was taught to have them make a fist; don’t have them make a fist,” she said, explaining that this recruits intrinsic muscles which basically allows cheating that may mask weakness.
Instead, ask them to flex just their distal interphalangeal joints by making a claw and using the fingers to pull against your fingers, she suggested.
Mixed myopathic and neuropathic features on electromyography also indicate IBM, she said.
Muscle biopsy may be helpful, but inclusions are seen in less than one-third of IBM patients.
“At times, we have had to biopsy three times to see them at all, and some people never show them, so you have to rely on your clinical acumen if you don’t see them,” she said.
Also, keep in mind that these patients are often labeled as having treatment-resistant polymyositis.
“Please, when somebody refers to you somebody that’s treatment resistant, that may be the case, but I want you to think maybe they’re treatment resistant because they don’t have that disease.”
Muscular dystrophy
Some cases of myositis mimic certain types of muscular dystrophy, Dr. Christopher-Stine said, providing a checklist of muscular dystrophies that can look “clinically completely indistinguishable from a typical inflammatory myopathy,” and should therefore be considered in these patients.
The checklist includes Duchenne’s manifesting carrier, limb girdle muscular dystrophy type 2b, myotonic dystrophy (usually type 2), and facioscapulohumeral muscular dystrophy.
Dr. Christopher-Stine reported having intellectual property interest in a novel Inova Diagnostics autoantibody assay detection for anti-HMGCR. She was also the safety officer for the JBT-101 Trial sponsored by Corbus and funded by the National Institutes of Health.
EXPERT ANALYSIS FROM THE WINTER RHEUMATOLOGY SYMPOSIUM
Child suicides rock Kentucky county; lack of access to care burdens rural Arizona
The people of Fayette County, Ky., reportedly have experienced five suicides by children in the last year. The latest suicide occurred several weeks ago and involved a 12-year-old girl. This followed the suicides of children aged 10, 11, 13, and 14 years.
The deaths are not related, and there seems to be no connection to race or gender. All involved hanging, and one child might have been bullied.
The cases reflect a disturbing trend in Kentucky and across the country. In 2015, 25% of suicides of children under 17 years in Kentucky involved those aged 10-14, a 14% increase from 4 years earlier. The percentage of 6th-grade students who have thought about or planned their suicide also has climbed in recent years.
Fayette County Coroner Gary W. Ginn said the deaths in Kentucky provide another example of how events in life that might be less traumatic to adults can cause mental anguish for children, anguish which can lead some to take their own lives.
“We should be very worried to have this many cases, but we should not be hopeless,“ said Susan H. Pollack, MD, a pediatrician at the University of Kentucky Children’s Hospital, Lexington, in an interview with the Lexington Herald-Leader. She added that resources and programs are available but that stronger support systems focusing on youth are needed.
“Our families have limited options when their child needs a higher level of care. ... Local agencies often have a wait list,” Fayette County Public Schools spokeswoman Lisa Deffendall said in the article. “We have made referrals and seen it take weeks for children to get the help they need. Where do families turn when their child is in crisis? Who provides care when school is not in session?”
Rural Arizona facing crisis
Living in rural areas can prove isolating, and gaining access to health care, including mental health care, can be challenging. A segment presented on KOLD News 13 in Tucson provided yet another examples of the mental health crisis in rural America.
Cochise County is an area of about 6,200 square miles in the southeast corner of Arizona. The area, which is about eight times bigger than New York City, is home to about 125,000 people. For those with mental health issues, it’s a bleak place to live, with only two psychiatrists available and no mental health facility.
“It’s as if we got a fire going that we can’t put out,” said James P. Reed, DO, in an interview. He is one of the two psychiatrists practicing in the county. In the last 2 months alone, 64 new people have sought his help, and he has had to turn many away.
Dr. Reed has been practicing in the country for 35 years, which gives him a longer-term perspective. “It’s so much worse now. I don’t know what it is, if it’s a consequence of our society and the direction it’s going. I just can’t put my finger on it.”
The main reason behind the paucity of mental health professionals comes down to economics. Burdened with student loan debts after graduation from medical school, the low salaries of rural positions cripple the recruitment of psychiatrists and other medical professionals.
In Cochise County, as elsewhere, the main refuge for people with mental illness is jail. “We have people in there [who] really shouldn’t be in there,” said Cochise County Sheriff Mark J. Dannels. “These people need special help that I can’t provide to them. It’s almost a misjustice to have them in our jail. Unfortunately, there’s no other place to put them.”
Perils of involuntary mental health holds
South Dakota is one of five states where jailing people with mental illness is part of a deliberate strategy, and the state’s new governor wants to change the practice.
“They’re not criminals,” Gov. Kristi Noem said in an article published in the Sioux Falls Argus Leader. “They’re having a crisis at a point in time when they need to be observed, but unfortunately, in a lot of communities, that’s the only option that folks have.”
The article cited the case of Nick Johnson, a 14-year-old whose mental health struggles include the loss of control that can include aggressiveness. Although not charged with any offense, the response had been stints in the Minnehaha County Juvenile Detention Center. “It feels like I’m in prison,” Nick said. “Why would a kid have to go through that?”
National advocacy groups have criticized the practice of imprisoning people with mental illness, and local jail officials have complained that their facilities have not been designed to deliver mental health treatment. “If you look at it from a strictly medical perspective, being in a jail setting is almost guaranteed to make somebody’s mental health crisis worse, not better,” said Lisa Dailey, legislative and policy counsel for the Treatment Advocacy Center, a national nonprofit that surveys and ranks states for their mental health policies. “It’s the worst possible thing you could do.” The report said the other states that take this approach toward people with mental illness are Texas, Wyoming, New Mexico, and North Dakota.
Cutbacks may hit recovery centers
Idaho’s nine crisis centers are in peril in the first year of the administration of Gov. Brad Little. The centers, located in nine of the state’s cities, collectively had requested about $890,000 from the Idaho Millennium Fund that would enable them to stabilize precarious financing and improve outreach efforts in surrounding rural communities.
However, as the Idaho Statesman reported, the funding request did not make it to the governor’s budget recommendation for 2020. Instead, the governor intends to use the Millennium Fund funds to expand Medicaid coverage. The consequence of the lack of state financial support could be the shuttering of all nine centers. If that happens, it would be much harder for those in the throes of or recovering from addiction or mental health issues to find the support they need.
“[The centers’] continued survival has been something of a miracle already,” said Norma Jaeger, executive director of Recovery Idaho. The organization had submitted the funding request on behalf of the nine centers. “Hopefully, a better funding solution is on the horizon,” said Ms. Jaeger.
Some in government disagree with that view, contending that the ongoing use of the Millennium Fund was never in the plans and that the centers were expected to seek other nongovernmental sources of funding. This tact is contrary to the traditional state funding of mental health and substance abuse programs. The legality of the move is being considered by the state Supreme Court.
Mental health and religious faith
A recent article in the Philadelphia Inquirer related the downsides and upsides of religious belief in the struggle against depression. The article discussed Yashi Brown, who at age 20, dealt with a bout of depression that led to manic episodes and contemplation of suicide. To her dismay, Ms. Brown found that her Jehovah’s Witness faith community was of little help.
Twenty years later, Ms. Brown, who now works as a mental health advocate in Los Angeles, better understands why relying on the faith’s teachings did not work. “I was in the throes of a manic episode,” she said. “I didn’t even have the tools to say a prayer.”
Ms. Brown’s experience highlights the burden faced by some religious traditions in helping church members with mental health issues. Instead of receiving tangible care from mental health professionals, those who are suffering can be told to rely on faith alone. The fallout is especially profound for African Americans like Ms. Brown, research shows. African Americans are 20% more likely to experience serious psychological distress than their white counterparts but are less likely to seek help – even if they can financially afford it.
The racial/ethnic disparities in health care that affect African Americans partly explains this reticence to seek treatment. Another factor is the multigenerational acceptance among some African Americans of mental trauma as a normal part of life, according to Meagan McLeod, a pastor and spiritual care director for Friends Hospital, a psychiatric hospital in northeast Philadelphia. “The idea is, if prayer worked for our ancestors when we were in slavery, then prayer has to be able to work now,” said Ms. McLeod.
Meanwhile, the article said, mental health professionals and clergy think that faith and mental health treatment “can – and should – work together. Research suggests higher levels of religiosity or spirituality are associated with lower rates of depression, anxiety, substance use disorder, and suicidal thoughts. Prayer can have the same calming effects as meditation,” such as both lowering blood pressure and respiratory rates. Incorporating religious approaches into the mental health treatment of African American patients might be particularly helpful, the article said.
The people of Fayette County, Ky., reportedly have experienced five suicides by children in the last year. The latest suicide occurred several weeks ago and involved a 12-year-old girl. This followed the suicides of children aged 10, 11, 13, and 14 years.
The deaths are not related, and there seems to be no connection to race or gender. All involved hanging, and one child might have been bullied.
The cases reflect a disturbing trend in Kentucky and across the country. In 2015, 25% of suicides of children under 17 years in Kentucky involved those aged 10-14, a 14% increase from 4 years earlier. The percentage of 6th-grade students who have thought about or planned their suicide also has climbed in recent years.
Fayette County Coroner Gary W. Ginn said the deaths in Kentucky provide another example of how events in life that might be less traumatic to adults can cause mental anguish for children, anguish which can lead some to take their own lives.
“We should be very worried to have this many cases, but we should not be hopeless,“ said Susan H. Pollack, MD, a pediatrician at the University of Kentucky Children’s Hospital, Lexington, in an interview with the Lexington Herald-Leader. She added that resources and programs are available but that stronger support systems focusing on youth are needed.
“Our families have limited options when their child needs a higher level of care. ... Local agencies often have a wait list,” Fayette County Public Schools spokeswoman Lisa Deffendall said in the article. “We have made referrals and seen it take weeks for children to get the help they need. Where do families turn when their child is in crisis? Who provides care when school is not in session?”
Rural Arizona facing crisis
Living in rural areas can prove isolating, and gaining access to health care, including mental health care, can be challenging. A segment presented on KOLD News 13 in Tucson provided yet another examples of the mental health crisis in rural America.
Cochise County is an area of about 6,200 square miles in the southeast corner of Arizona. The area, which is about eight times bigger than New York City, is home to about 125,000 people. For those with mental health issues, it’s a bleak place to live, with only two psychiatrists available and no mental health facility.
“It’s as if we got a fire going that we can’t put out,” said James P. Reed, DO, in an interview. He is one of the two psychiatrists practicing in the county. In the last 2 months alone, 64 new people have sought his help, and he has had to turn many away.
Dr. Reed has been practicing in the country for 35 years, which gives him a longer-term perspective. “It’s so much worse now. I don’t know what it is, if it’s a consequence of our society and the direction it’s going. I just can’t put my finger on it.”
The main reason behind the paucity of mental health professionals comes down to economics. Burdened with student loan debts after graduation from medical school, the low salaries of rural positions cripple the recruitment of psychiatrists and other medical professionals.
In Cochise County, as elsewhere, the main refuge for people with mental illness is jail. “We have people in there [who] really shouldn’t be in there,” said Cochise County Sheriff Mark J. Dannels. “These people need special help that I can’t provide to them. It’s almost a misjustice to have them in our jail. Unfortunately, there’s no other place to put them.”
Perils of involuntary mental health holds
South Dakota is one of five states where jailing people with mental illness is part of a deliberate strategy, and the state’s new governor wants to change the practice.
“They’re not criminals,” Gov. Kristi Noem said in an article published in the Sioux Falls Argus Leader. “They’re having a crisis at a point in time when they need to be observed, but unfortunately, in a lot of communities, that’s the only option that folks have.”
The article cited the case of Nick Johnson, a 14-year-old whose mental health struggles include the loss of control that can include aggressiveness. Although not charged with any offense, the response had been stints in the Minnehaha County Juvenile Detention Center. “It feels like I’m in prison,” Nick said. “Why would a kid have to go through that?”
National advocacy groups have criticized the practice of imprisoning people with mental illness, and local jail officials have complained that their facilities have not been designed to deliver mental health treatment. “If you look at it from a strictly medical perspective, being in a jail setting is almost guaranteed to make somebody’s mental health crisis worse, not better,” said Lisa Dailey, legislative and policy counsel for the Treatment Advocacy Center, a national nonprofit that surveys and ranks states for their mental health policies. “It’s the worst possible thing you could do.” The report said the other states that take this approach toward people with mental illness are Texas, Wyoming, New Mexico, and North Dakota.
Cutbacks may hit recovery centers
Idaho’s nine crisis centers are in peril in the first year of the administration of Gov. Brad Little. The centers, located in nine of the state’s cities, collectively had requested about $890,000 from the Idaho Millennium Fund that would enable them to stabilize precarious financing and improve outreach efforts in surrounding rural communities.
However, as the Idaho Statesman reported, the funding request did not make it to the governor’s budget recommendation for 2020. Instead, the governor intends to use the Millennium Fund funds to expand Medicaid coverage. The consequence of the lack of state financial support could be the shuttering of all nine centers. If that happens, it would be much harder for those in the throes of or recovering from addiction or mental health issues to find the support they need.
“[The centers’] continued survival has been something of a miracle already,” said Norma Jaeger, executive director of Recovery Idaho. The organization had submitted the funding request on behalf of the nine centers. “Hopefully, a better funding solution is on the horizon,” said Ms. Jaeger.
Some in government disagree with that view, contending that the ongoing use of the Millennium Fund was never in the plans and that the centers were expected to seek other nongovernmental sources of funding. This tact is contrary to the traditional state funding of mental health and substance abuse programs. The legality of the move is being considered by the state Supreme Court.
Mental health and religious faith
A recent article in the Philadelphia Inquirer related the downsides and upsides of religious belief in the struggle against depression. The article discussed Yashi Brown, who at age 20, dealt with a bout of depression that led to manic episodes and contemplation of suicide. To her dismay, Ms. Brown found that her Jehovah’s Witness faith community was of little help.
Twenty years later, Ms. Brown, who now works as a mental health advocate in Los Angeles, better understands why relying on the faith’s teachings did not work. “I was in the throes of a manic episode,” she said. “I didn’t even have the tools to say a prayer.”
Ms. Brown’s experience highlights the burden faced by some religious traditions in helping church members with mental health issues. Instead of receiving tangible care from mental health professionals, those who are suffering can be told to rely on faith alone. The fallout is especially profound for African Americans like Ms. Brown, research shows. African Americans are 20% more likely to experience serious psychological distress than their white counterparts but are less likely to seek help – even if they can financially afford it.
The racial/ethnic disparities in health care that affect African Americans partly explains this reticence to seek treatment. Another factor is the multigenerational acceptance among some African Americans of mental trauma as a normal part of life, according to Meagan McLeod, a pastor and spiritual care director for Friends Hospital, a psychiatric hospital in northeast Philadelphia. “The idea is, if prayer worked for our ancestors when we were in slavery, then prayer has to be able to work now,” said Ms. McLeod.
Meanwhile, the article said, mental health professionals and clergy think that faith and mental health treatment “can – and should – work together. Research suggests higher levels of religiosity or spirituality are associated with lower rates of depression, anxiety, substance use disorder, and suicidal thoughts. Prayer can have the same calming effects as meditation,” such as both lowering blood pressure and respiratory rates. Incorporating religious approaches into the mental health treatment of African American patients might be particularly helpful, the article said.
The people of Fayette County, Ky., reportedly have experienced five suicides by children in the last year. The latest suicide occurred several weeks ago and involved a 12-year-old girl. This followed the suicides of children aged 10, 11, 13, and 14 years.
The deaths are not related, and there seems to be no connection to race or gender. All involved hanging, and one child might have been bullied.
The cases reflect a disturbing trend in Kentucky and across the country. In 2015, 25% of suicides of children under 17 years in Kentucky involved those aged 10-14, a 14% increase from 4 years earlier. The percentage of 6th-grade students who have thought about or planned their suicide also has climbed in recent years.
Fayette County Coroner Gary W. Ginn said the deaths in Kentucky provide another example of how events in life that might be less traumatic to adults can cause mental anguish for children, anguish which can lead some to take their own lives.
“We should be very worried to have this many cases, but we should not be hopeless,“ said Susan H. Pollack, MD, a pediatrician at the University of Kentucky Children’s Hospital, Lexington, in an interview with the Lexington Herald-Leader. She added that resources and programs are available but that stronger support systems focusing on youth are needed.
“Our families have limited options when their child needs a higher level of care. ... Local agencies often have a wait list,” Fayette County Public Schools spokeswoman Lisa Deffendall said in the article. “We have made referrals and seen it take weeks for children to get the help they need. Where do families turn when their child is in crisis? Who provides care when school is not in session?”
Rural Arizona facing crisis
Living in rural areas can prove isolating, and gaining access to health care, including mental health care, can be challenging. A segment presented on KOLD News 13 in Tucson provided yet another examples of the mental health crisis in rural America.
Cochise County is an area of about 6,200 square miles in the southeast corner of Arizona. The area, which is about eight times bigger than New York City, is home to about 125,000 people. For those with mental health issues, it’s a bleak place to live, with only two psychiatrists available and no mental health facility.
“It’s as if we got a fire going that we can’t put out,” said James P. Reed, DO, in an interview. He is one of the two psychiatrists practicing in the county. In the last 2 months alone, 64 new people have sought his help, and he has had to turn many away.
Dr. Reed has been practicing in the country for 35 years, which gives him a longer-term perspective. “It’s so much worse now. I don’t know what it is, if it’s a consequence of our society and the direction it’s going. I just can’t put my finger on it.”
The main reason behind the paucity of mental health professionals comes down to economics. Burdened with student loan debts after graduation from medical school, the low salaries of rural positions cripple the recruitment of psychiatrists and other medical professionals.
In Cochise County, as elsewhere, the main refuge for people with mental illness is jail. “We have people in there [who] really shouldn’t be in there,” said Cochise County Sheriff Mark J. Dannels. “These people need special help that I can’t provide to them. It’s almost a misjustice to have them in our jail. Unfortunately, there’s no other place to put them.”
Perils of involuntary mental health holds
South Dakota is one of five states where jailing people with mental illness is part of a deliberate strategy, and the state’s new governor wants to change the practice.
“They’re not criminals,” Gov. Kristi Noem said in an article published in the Sioux Falls Argus Leader. “They’re having a crisis at a point in time when they need to be observed, but unfortunately, in a lot of communities, that’s the only option that folks have.”
The article cited the case of Nick Johnson, a 14-year-old whose mental health struggles include the loss of control that can include aggressiveness. Although not charged with any offense, the response had been stints in the Minnehaha County Juvenile Detention Center. “It feels like I’m in prison,” Nick said. “Why would a kid have to go through that?”
National advocacy groups have criticized the practice of imprisoning people with mental illness, and local jail officials have complained that their facilities have not been designed to deliver mental health treatment. “If you look at it from a strictly medical perspective, being in a jail setting is almost guaranteed to make somebody’s mental health crisis worse, not better,” said Lisa Dailey, legislative and policy counsel for the Treatment Advocacy Center, a national nonprofit that surveys and ranks states for their mental health policies. “It’s the worst possible thing you could do.” The report said the other states that take this approach toward people with mental illness are Texas, Wyoming, New Mexico, and North Dakota.
Cutbacks may hit recovery centers
Idaho’s nine crisis centers are in peril in the first year of the administration of Gov. Brad Little. The centers, located in nine of the state’s cities, collectively had requested about $890,000 from the Idaho Millennium Fund that would enable them to stabilize precarious financing and improve outreach efforts in surrounding rural communities.
However, as the Idaho Statesman reported, the funding request did not make it to the governor’s budget recommendation for 2020. Instead, the governor intends to use the Millennium Fund funds to expand Medicaid coverage. The consequence of the lack of state financial support could be the shuttering of all nine centers. If that happens, it would be much harder for those in the throes of or recovering from addiction or mental health issues to find the support they need.
“[The centers’] continued survival has been something of a miracle already,” said Norma Jaeger, executive director of Recovery Idaho. The organization had submitted the funding request on behalf of the nine centers. “Hopefully, a better funding solution is on the horizon,” said Ms. Jaeger.
Some in government disagree with that view, contending that the ongoing use of the Millennium Fund was never in the plans and that the centers were expected to seek other nongovernmental sources of funding. This tact is contrary to the traditional state funding of mental health and substance abuse programs. The legality of the move is being considered by the state Supreme Court.
Mental health and religious faith
A recent article in the Philadelphia Inquirer related the downsides and upsides of religious belief in the struggle against depression. The article discussed Yashi Brown, who at age 20, dealt with a bout of depression that led to manic episodes and contemplation of suicide. To her dismay, Ms. Brown found that her Jehovah’s Witness faith community was of little help.
Twenty years later, Ms. Brown, who now works as a mental health advocate in Los Angeles, better understands why relying on the faith’s teachings did not work. “I was in the throes of a manic episode,” she said. “I didn’t even have the tools to say a prayer.”
Ms. Brown’s experience highlights the burden faced by some religious traditions in helping church members with mental health issues. Instead of receiving tangible care from mental health professionals, those who are suffering can be told to rely on faith alone. The fallout is especially profound for African Americans like Ms. Brown, research shows. African Americans are 20% more likely to experience serious psychological distress than their white counterparts but are less likely to seek help – even if they can financially afford it.
The racial/ethnic disparities in health care that affect African Americans partly explains this reticence to seek treatment. Another factor is the multigenerational acceptance among some African Americans of mental trauma as a normal part of life, according to Meagan McLeod, a pastor and spiritual care director for Friends Hospital, a psychiatric hospital in northeast Philadelphia. “The idea is, if prayer worked for our ancestors when we were in slavery, then prayer has to be able to work now,” said Ms. McLeod.
Meanwhile, the article said, mental health professionals and clergy think that faith and mental health treatment “can – and should – work together. Research suggests higher levels of religiosity or spirituality are associated with lower rates of depression, anxiety, substance use disorder, and suicidal thoughts. Prayer can have the same calming effects as meditation,” such as both lowering blood pressure and respiratory rates. Incorporating religious approaches into the mental health treatment of African American patients might be particularly helpful, the article said.
Matching clinical, claims data essential for value-based care
Finding success in alternative payment models is going to require infusing clinical data into administrative claims data.
This was the key takeaway of an analysis of data from a participant in the Oncology Care Model (OCM), a value-based episodic payment model being tested by the Centers for Medicare & Medicaid Service’s Center for Medicare and Medicaid Innovation.
Researchers looked at administrative claims data and infused into it clinical data from 377 6-month-long episode payments pertaining to 210 prostate cancer patients participating at a single OCM site to see if the combination could be used to develop more useful information that OCM participants could use to help improve care and control costs.
“In order to introduce these clinical factors, what we did was divide the patients that were included in our analysis into different disease-state treatment dyads,” Anish Parikh, MD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. Dr. Parikh is a coauthor of a report detailing the results of the analysis that was published in the Journal of Oncology Practice.
“Then we did a comparative cost analysis using the OCM’s data in this framework,” he continued. “We introduced these clinical factors this administrative claims data and then ran a comparative cost analysis to see what were the contributions to cost of care for each of these dyads.”
The analysis found that the most excessive expenses in prostate cancer treatment were seen in metastatic, castration-resistant dyads containing second-line hormone therapy (ratio of observed to expected expenses [O/E], 2.66), chemotherapy (O/E, 2.09) and radium-223/sipuleucel-T (O/E, 3.01).
During the observation period, the CMS updated the payment model, and a singular change correcting for castration-resistant prostate cancer resulted in up to a 38% increase in O/E for hormone-sensitive dyads and up to a 58% decrease in O/E for castration-resistant dyads. The update improved the overall O/E for all episodes by 22%, from 1.48 to 1.15.
The analysis “really is a demonstration of how sensitive this model is to clinical factors and how necessary and important it is to include clinical data into the administrative claims data whenever possible in order to make the model more accurate and usable,” Dr. Parikh said.
The investigators reported no conflicts of interest.
SOURCE: Parikh A et al. J Oncol Pract. 2019 Feb 11. doi: 10.1200/JOP.18.00336.
Finding success in alternative payment models is going to require infusing clinical data into administrative claims data.
This was the key takeaway of an analysis of data from a participant in the Oncology Care Model (OCM), a value-based episodic payment model being tested by the Centers for Medicare & Medicaid Service’s Center for Medicare and Medicaid Innovation.
Researchers looked at administrative claims data and infused into it clinical data from 377 6-month-long episode payments pertaining to 210 prostate cancer patients participating at a single OCM site to see if the combination could be used to develop more useful information that OCM participants could use to help improve care and control costs.
“In order to introduce these clinical factors, what we did was divide the patients that were included in our analysis into different disease-state treatment dyads,” Anish Parikh, MD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. Dr. Parikh is a coauthor of a report detailing the results of the analysis that was published in the Journal of Oncology Practice.
“Then we did a comparative cost analysis using the OCM’s data in this framework,” he continued. “We introduced these clinical factors this administrative claims data and then ran a comparative cost analysis to see what were the contributions to cost of care for each of these dyads.”
The analysis found that the most excessive expenses in prostate cancer treatment were seen in metastatic, castration-resistant dyads containing second-line hormone therapy (ratio of observed to expected expenses [O/E], 2.66), chemotherapy (O/E, 2.09) and radium-223/sipuleucel-T (O/E, 3.01).
During the observation period, the CMS updated the payment model, and a singular change correcting for castration-resistant prostate cancer resulted in up to a 38% increase in O/E for hormone-sensitive dyads and up to a 58% decrease in O/E for castration-resistant dyads. The update improved the overall O/E for all episodes by 22%, from 1.48 to 1.15.
The analysis “really is a demonstration of how sensitive this model is to clinical factors and how necessary and important it is to include clinical data into the administrative claims data whenever possible in order to make the model more accurate and usable,” Dr. Parikh said.
The investigators reported no conflicts of interest.
SOURCE: Parikh A et al. J Oncol Pract. 2019 Feb 11. doi: 10.1200/JOP.18.00336.
Finding success in alternative payment models is going to require infusing clinical data into administrative claims data.
This was the key takeaway of an analysis of data from a participant in the Oncology Care Model (OCM), a value-based episodic payment model being tested by the Centers for Medicare & Medicaid Service’s Center for Medicare and Medicaid Innovation.
Researchers looked at administrative claims data and infused into it clinical data from 377 6-month-long episode payments pertaining to 210 prostate cancer patients participating at a single OCM site to see if the combination could be used to develop more useful information that OCM participants could use to help improve care and control costs.
“In order to introduce these clinical factors, what we did was divide the patients that were included in our analysis into different disease-state treatment dyads,” Anish Parikh, MD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. Dr. Parikh is a coauthor of a report detailing the results of the analysis that was published in the Journal of Oncology Practice.
“Then we did a comparative cost analysis using the OCM’s data in this framework,” he continued. “We introduced these clinical factors this administrative claims data and then ran a comparative cost analysis to see what were the contributions to cost of care for each of these dyads.”
The analysis found that the most excessive expenses in prostate cancer treatment were seen in metastatic, castration-resistant dyads containing second-line hormone therapy (ratio of observed to expected expenses [O/E], 2.66), chemotherapy (O/E, 2.09) and radium-223/sipuleucel-T (O/E, 3.01).
During the observation period, the CMS updated the payment model, and a singular change correcting for castration-resistant prostate cancer resulted in up to a 38% increase in O/E for hormone-sensitive dyads and up to a 58% decrease in O/E for castration-resistant dyads. The update improved the overall O/E for all episodes by 22%, from 1.48 to 1.15.
The analysis “really is a demonstration of how sensitive this model is to clinical factors and how necessary and important it is to include clinical data into the administrative claims data whenever possible in order to make the model more accurate and usable,” Dr. Parikh said.
The investigators reported no conflicts of interest.
SOURCE: Parikh A et al. J Oncol Pract. 2019 Feb 11. doi: 10.1200/JOP.18.00336.
FROM THE JOURNAL OF ONCOLOGY PRACTICE
Supplementary compression doesn’t improve DVT odds in critically ill
SAN DIEGO – In critically ill patients receiving pharmacologic thromboprophylaxis, (DVT), according to a new trial.
“I was surprised. My hypothesis was that it would work,” said lead author Yaseen M. Arabi, MD, chairman of the intensive care department at King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Many physicians routinely carry out the practice on the assumption that IPC should lead to better blood flow and further cut DVT risk. The procedure carries few risks, aside from patient discomfort. “The main issue is that it’s not needed. It might be useful in patients who are not receiving heparin or low-molecular-weight heparin,” said Dr. Arabi, who presented the results of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published online in the New England Journal of Medicine.
Unfractionated or low-molecular-weight heparin reduces the risk of DVT by about 50%, but about 5%-20% of critically ill patients will develop DVT in spite of treatment, and mechanical thromboprophylaxis reduces DVT risk, compared with no prophylaxis. Some researchers have attempted to address whether adjunct intermittent pneumatic compression could further reduce DVT risk, but their studies were marked by a lack of controls, unoptimized pharmacologic regimens, and other limitations.
The trial included 2,003 adults from 20 sites in Saudi Arabia, Canada, Australia, and India, who were expected to have an intensive care unit stay of at least 72 hours. They were randomized to receive IPC combined with pharmacologic thromboprophylaxis (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control).
The proportion of patients receiving unfractionated heparin versus low-molecular-weight heparin was similar between the two groups, with about 58% treated with unfractionated heparin.
A total of 3.9% of patients in the pneumatic compression group experienced incident proximal DVT, compared with 4.2% of controls (relative risk, 0.93; P =.74). A total of 3.4% experienced prevalent proximal DVT, compared with 2.7% of controls (RR, 1.29; 95% confidence interval, 0.78-2.12). There was no significant difference in the incidence of any lower-limb DVT (9.6% vs. 8.4%; RR, 1.14; 95% CI, 0.86-1.51).
There was no difference between the two groups in a composite outcome that included pulmonary embolism or all prevalent and incident lower-limb DVT (RR, 1.11; 95% CI, 0.85-1.44), and there were no between-group differences with respect to lower-limb skin injury or ischemia.
The results should change practice among those who still provide adjunct intermittent pneumatic compression, however surprising physicians may find these new results to be, according to Dr. Arabi: “People believed strongly that (adjunct IPC) should work, but you need to be evidence based, and here it showed no difference. But that’s why we do studies, right?”
The study was funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center. Dr. Arabi has no relevant financial conflicts.
SOURCE: Arabi Y et al. CCC48, Abstract 142. N Engl J Med Feb 18. doi: 10.1056/NEJMoa1816150.
SAN DIEGO – In critically ill patients receiving pharmacologic thromboprophylaxis, (DVT), according to a new trial.
“I was surprised. My hypothesis was that it would work,” said lead author Yaseen M. Arabi, MD, chairman of the intensive care department at King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Many physicians routinely carry out the practice on the assumption that IPC should lead to better blood flow and further cut DVT risk. The procedure carries few risks, aside from patient discomfort. “The main issue is that it’s not needed. It might be useful in patients who are not receiving heparin or low-molecular-weight heparin,” said Dr. Arabi, who presented the results of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published online in the New England Journal of Medicine.
Unfractionated or low-molecular-weight heparin reduces the risk of DVT by about 50%, but about 5%-20% of critically ill patients will develop DVT in spite of treatment, and mechanical thromboprophylaxis reduces DVT risk, compared with no prophylaxis. Some researchers have attempted to address whether adjunct intermittent pneumatic compression could further reduce DVT risk, but their studies were marked by a lack of controls, unoptimized pharmacologic regimens, and other limitations.
The trial included 2,003 adults from 20 sites in Saudi Arabia, Canada, Australia, and India, who were expected to have an intensive care unit stay of at least 72 hours. They were randomized to receive IPC combined with pharmacologic thromboprophylaxis (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control).
The proportion of patients receiving unfractionated heparin versus low-molecular-weight heparin was similar between the two groups, with about 58% treated with unfractionated heparin.
A total of 3.9% of patients in the pneumatic compression group experienced incident proximal DVT, compared with 4.2% of controls (relative risk, 0.93; P =.74). A total of 3.4% experienced prevalent proximal DVT, compared with 2.7% of controls (RR, 1.29; 95% confidence interval, 0.78-2.12). There was no significant difference in the incidence of any lower-limb DVT (9.6% vs. 8.4%; RR, 1.14; 95% CI, 0.86-1.51).
There was no difference between the two groups in a composite outcome that included pulmonary embolism or all prevalent and incident lower-limb DVT (RR, 1.11; 95% CI, 0.85-1.44), and there were no between-group differences with respect to lower-limb skin injury or ischemia.
The results should change practice among those who still provide adjunct intermittent pneumatic compression, however surprising physicians may find these new results to be, according to Dr. Arabi: “People believed strongly that (adjunct IPC) should work, but you need to be evidence based, and here it showed no difference. But that’s why we do studies, right?”
The study was funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center. Dr. Arabi has no relevant financial conflicts.
SOURCE: Arabi Y et al. CCC48, Abstract 142. N Engl J Med Feb 18. doi: 10.1056/NEJMoa1816150.
SAN DIEGO – In critically ill patients receiving pharmacologic thromboprophylaxis, (DVT), according to a new trial.
“I was surprised. My hypothesis was that it would work,” said lead author Yaseen M. Arabi, MD, chairman of the intensive care department at King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Many physicians routinely carry out the practice on the assumption that IPC should lead to better blood flow and further cut DVT risk. The procedure carries few risks, aside from patient discomfort. “The main issue is that it’s not needed. It might be useful in patients who are not receiving heparin or low-molecular-weight heparin,” said Dr. Arabi, who presented the results of the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine. The study was simultaneously published online in the New England Journal of Medicine.
Unfractionated or low-molecular-weight heparin reduces the risk of DVT by about 50%, but about 5%-20% of critically ill patients will develop DVT in spite of treatment, and mechanical thromboprophylaxis reduces DVT risk, compared with no prophylaxis. Some researchers have attempted to address whether adjunct intermittent pneumatic compression could further reduce DVT risk, but their studies were marked by a lack of controls, unoptimized pharmacologic regimens, and other limitations.
The trial included 2,003 adults from 20 sites in Saudi Arabia, Canada, Australia, and India, who were expected to have an intensive care unit stay of at least 72 hours. They were randomized to receive IPC combined with pharmacologic thromboprophylaxis (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control).
The proportion of patients receiving unfractionated heparin versus low-molecular-weight heparin was similar between the two groups, with about 58% treated with unfractionated heparin.
A total of 3.9% of patients in the pneumatic compression group experienced incident proximal DVT, compared with 4.2% of controls (relative risk, 0.93; P =.74). A total of 3.4% experienced prevalent proximal DVT, compared with 2.7% of controls (RR, 1.29; 95% confidence interval, 0.78-2.12). There was no significant difference in the incidence of any lower-limb DVT (9.6% vs. 8.4%; RR, 1.14; 95% CI, 0.86-1.51).
There was no difference between the two groups in a composite outcome that included pulmonary embolism or all prevalent and incident lower-limb DVT (RR, 1.11; 95% CI, 0.85-1.44), and there were no between-group differences with respect to lower-limb skin injury or ischemia.
The results should change practice among those who still provide adjunct intermittent pneumatic compression, however surprising physicians may find these new results to be, according to Dr. Arabi: “People believed strongly that (adjunct IPC) should work, but you need to be evidence based, and here it showed no difference. But that’s why we do studies, right?”
The study was funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center. Dr. Arabi has no relevant financial conflicts.
SOURCE: Arabi Y et al. CCC48, Abstract 142. N Engl J Med Feb 18. doi: 10.1056/NEJMoa1816150.
REPORTING FROM CCC48
A novel approach to MIPS quality reporting for facility-based providers
A cornerstone of hospital medicine is the delivery of high-quality inpatient care by improving the performance of the systems and facilities in which hospitalists work. By extension, hospitalists are often held accountable, in varying ways, for improving the performance of facility metrics, such as those in the Hospital Value-Based Purchasing (HVBP), Inpatient Quality Reporting, and Hospital Readmissions Reduction programs.
Despite the work hospitalists were already doing to improve both efficiency and quality within their institutions, the 2010 Affordable Care Act introduced penalties for clinicians who did not submit qualifying provider-level data via the Physician Quality Reporting System program. Initially only an incentive program, PQRS was ultimately incorporated into the Physician Value-Based Payment (VBP) Modifier to make performance-based payment adjustments to Medicare physician payment. At this point, many hospitalists were not only accountable for helping to improve the metrics of their facilities, but also required to report individually or within their groups on provider-level measures, many of which were irrelevant to hospital medicine practice.
With this dual burden becoming evident, the Society of Hospital Medicine approached the Centers for Medicare & Medicaid Services with a possible solution. Could hospitalists elect to use their facilities’ metrics as a stand-in for the provider level metrics? Not only would this reduce the burden of reporting irrelevant metrics, but it would also help alleviate some of the disadvantages hospitalists face within Physician VBP.
The CMS was initially very supportive of the concept, but informed the SHM such alignment was not possible under existing law. In brief, the law required Physician VBP to remain completely within the Physician Fee Schedule and its related metrics; facility level metrics from a different payment system could not be used.
Undeterred, the SHM sought opportunities to change the law. As Congress was developing the Medicare Access and Chip Reauthorization Act (MACRA), the SHM worked closely with lawmakers to include language that would permit measures in “other payment systems” to be used for physician performance assessment. This language was retained in the final version of MACRA that was signed into law on April 16, 2015.
The SHM continued its advocacy, working closely with the CMS and its new authority to shape an option to align Medicare’s facility metrics and scores with provider reporting. Today that idea is a reality. Beginning this year, the CMS will have a new Merit-based Incentive Payment System (MIPS) reporting option available for hospitalists: facility-based measurement.
Facility-based measurement enables clinicians to receive a score for the Quality and Cost categories of the MIPS, without the need to collect and report on measures separately. Eligible providers would receive the MIPS score in those categories associated with the same percentile as their hospital’s score in HVBP. No more administrative work necessary to collect, clean and report on data for quality measures in the MIPS. If you are eligible, the CMS will automatically calculate a Quality and Cost score and combine this with your score from Improvement Activities and Promoting Interoperability (if you are not exempt) to give you a final MIPS score. If you decide to report on quality measures through the traditional MIPS pathway as well, the CMS will give you the higher of the scores.
There are certainly trade-offs associated with the facility-based measurement option. You do not have the burden of reporting measures on your own, but you do not get to pick what measures and what facility’s score you receive. Facility-level measures may be more difficult to improve performance, particularly as an individual, but the automatic application of facility-based measurement to eligible clinicians and groups serves as a backstop for MIPS reporting.
Aligning facility and clinician performance should encourage collaboration and innovation to meet these shared goals. As such, facility-based measurement represents a massive philosophical and practical shift in CMS measure reporting. As we enter these uncharted waters together, we hope to continue learning from your experiences and perspectives and working to refine facility-based measurement in the future.
For more information about facility-based reporting and the MIPS in general, visit www.macraforhm.org.
Mr. Lapps is government relations senior manager and Mr. Boswell is government relations director at the Society of Hospital Medicine.
Who is eligible for facility-based measurement?
- Individual providers who bill more than 75% of their Medicare Part B professional services in Place of Service 21 (Emergency Department), 22 (Hospital Outpatient), and 23 (Inpatient Hospital), billing at least one service in POS 21 or 23, and work in a hospital with an HVBP score.
- Groups who have at least 75% of their individual clinicians who meet the eligibility criteria.
- Nearly all hospitalists should qualify for facility-based measurement as individuals, while group eligibility depends on the demographics of their staff.
A cornerstone of hospital medicine is the delivery of high-quality inpatient care by improving the performance of the systems and facilities in which hospitalists work. By extension, hospitalists are often held accountable, in varying ways, for improving the performance of facility metrics, such as those in the Hospital Value-Based Purchasing (HVBP), Inpatient Quality Reporting, and Hospital Readmissions Reduction programs.
Despite the work hospitalists were already doing to improve both efficiency and quality within their institutions, the 2010 Affordable Care Act introduced penalties for clinicians who did not submit qualifying provider-level data via the Physician Quality Reporting System program. Initially only an incentive program, PQRS was ultimately incorporated into the Physician Value-Based Payment (VBP) Modifier to make performance-based payment adjustments to Medicare physician payment. At this point, many hospitalists were not only accountable for helping to improve the metrics of their facilities, but also required to report individually or within their groups on provider-level measures, many of which were irrelevant to hospital medicine practice.
With this dual burden becoming evident, the Society of Hospital Medicine approached the Centers for Medicare & Medicaid Services with a possible solution. Could hospitalists elect to use their facilities’ metrics as a stand-in for the provider level metrics? Not only would this reduce the burden of reporting irrelevant metrics, but it would also help alleviate some of the disadvantages hospitalists face within Physician VBP.
The CMS was initially very supportive of the concept, but informed the SHM such alignment was not possible under existing law. In brief, the law required Physician VBP to remain completely within the Physician Fee Schedule and its related metrics; facility level metrics from a different payment system could not be used.
Undeterred, the SHM sought opportunities to change the law. As Congress was developing the Medicare Access and Chip Reauthorization Act (MACRA), the SHM worked closely with lawmakers to include language that would permit measures in “other payment systems” to be used for physician performance assessment. This language was retained in the final version of MACRA that was signed into law on April 16, 2015.
The SHM continued its advocacy, working closely with the CMS and its new authority to shape an option to align Medicare’s facility metrics and scores with provider reporting. Today that idea is a reality. Beginning this year, the CMS will have a new Merit-based Incentive Payment System (MIPS) reporting option available for hospitalists: facility-based measurement.
Facility-based measurement enables clinicians to receive a score for the Quality and Cost categories of the MIPS, without the need to collect and report on measures separately. Eligible providers would receive the MIPS score in those categories associated with the same percentile as their hospital’s score in HVBP. No more administrative work necessary to collect, clean and report on data for quality measures in the MIPS. If you are eligible, the CMS will automatically calculate a Quality and Cost score and combine this with your score from Improvement Activities and Promoting Interoperability (if you are not exempt) to give you a final MIPS score. If you decide to report on quality measures through the traditional MIPS pathway as well, the CMS will give you the higher of the scores.
There are certainly trade-offs associated with the facility-based measurement option. You do not have the burden of reporting measures on your own, but you do not get to pick what measures and what facility’s score you receive. Facility-level measures may be more difficult to improve performance, particularly as an individual, but the automatic application of facility-based measurement to eligible clinicians and groups serves as a backstop for MIPS reporting.
Aligning facility and clinician performance should encourage collaboration and innovation to meet these shared goals. As such, facility-based measurement represents a massive philosophical and practical shift in CMS measure reporting. As we enter these uncharted waters together, we hope to continue learning from your experiences and perspectives and working to refine facility-based measurement in the future.
For more information about facility-based reporting and the MIPS in general, visit www.macraforhm.org.
Mr. Lapps is government relations senior manager and Mr. Boswell is government relations director at the Society of Hospital Medicine.
Who is eligible for facility-based measurement?
- Individual providers who bill more than 75% of their Medicare Part B professional services in Place of Service 21 (Emergency Department), 22 (Hospital Outpatient), and 23 (Inpatient Hospital), billing at least one service in POS 21 or 23, and work in a hospital with an HVBP score.
- Groups who have at least 75% of their individual clinicians who meet the eligibility criteria.
- Nearly all hospitalists should qualify for facility-based measurement as individuals, while group eligibility depends on the demographics of their staff.
A cornerstone of hospital medicine is the delivery of high-quality inpatient care by improving the performance of the systems and facilities in which hospitalists work. By extension, hospitalists are often held accountable, in varying ways, for improving the performance of facility metrics, such as those in the Hospital Value-Based Purchasing (HVBP), Inpatient Quality Reporting, and Hospital Readmissions Reduction programs.
Despite the work hospitalists were already doing to improve both efficiency and quality within their institutions, the 2010 Affordable Care Act introduced penalties for clinicians who did not submit qualifying provider-level data via the Physician Quality Reporting System program. Initially only an incentive program, PQRS was ultimately incorporated into the Physician Value-Based Payment (VBP) Modifier to make performance-based payment adjustments to Medicare physician payment. At this point, many hospitalists were not only accountable for helping to improve the metrics of their facilities, but also required to report individually or within their groups on provider-level measures, many of which were irrelevant to hospital medicine practice.
With this dual burden becoming evident, the Society of Hospital Medicine approached the Centers for Medicare & Medicaid Services with a possible solution. Could hospitalists elect to use their facilities’ metrics as a stand-in for the provider level metrics? Not only would this reduce the burden of reporting irrelevant metrics, but it would also help alleviate some of the disadvantages hospitalists face within Physician VBP.
The CMS was initially very supportive of the concept, but informed the SHM such alignment was not possible under existing law. In brief, the law required Physician VBP to remain completely within the Physician Fee Schedule and its related metrics; facility level metrics from a different payment system could not be used.
Undeterred, the SHM sought opportunities to change the law. As Congress was developing the Medicare Access and Chip Reauthorization Act (MACRA), the SHM worked closely with lawmakers to include language that would permit measures in “other payment systems” to be used for physician performance assessment. This language was retained in the final version of MACRA that was signed into law on April 16, 2015.
The SHM continued its advocacy, working closely with the CMS and its new authority to shape an option to align Medicare’s facility metrics and scores with provider reporting. Today that idea is a reality. Beginning this year, the CMS will have a new Merit-based Incentive Payment System (MIPS) reporting option available for hospitalists: facility-based measurement.
Facility-based measurement enables clinicians to receive a score for the Quality and Cost categories of the MIPS, without the need to collect and report on measures separately. Eligible providers would receive the MIPS score in those categories associated with the same percentile as their hospital’s score in HVBP. No more administrative work necessary to collect, clean and report on data for quality measures in the MIPS. If you are eligible, the CMS will automatically calculate a Quality and Cost score and combine this with your score from Improvement Activities and Promoting Interoperability (if you are not exempt) to give you a final MIPS score. If you decide to report on quality measures through the traditional MIPS pathway as well, the CMS will give you the higher of the scores.
There are certainly trade-offs associated with the facility-based measurement option. You do not have the burden of reporting measures on your own, but you do not get to pick what measures and what facility’s score you receive. Facility-level measures may be more difficult to improve performance, particularly as an individual, but the automatic application of facility-based measurement to eligible clinicians and groups serves as a backstop for MIPS reporting.
Aligning facility and clinician performance should encourage collaboration and innovation to meet these shared goals. As such, facility-based measurement represents a massive philosophical and practical shift in CMS measure reporting. As we enter these uncharted waters together, we hope to continue learning from your experiences and perspectives and working to refine facility-based measurement in the future.
For more information about facility-based reporting and the MIPS in general, visit www.macraforhm.org.
Mr. Lapps is government relations senior manager and Mr. Boswell is government relations director at the Society of Hospital Medicine.
Who is eligible for facility-based measurement?
- Individual providers who bill more than 75% of their Medicare Part B professional services in Place of Service 21 (Emergency Department), 22 (Hospital Outpatient), and 23 (Inpatient Hospital), billing at least one service in POS 21 or 23, and work in a hospital with an HVBP score.
- Groups who have at least 75% of their individual clinicians who meet the eligibility criteria.
- Nearly all hospitalists should qualify for facility-based measurement as individuals, while group eligibility depends on the demographics of their staff.
