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China's Changchun mayor resigns after vaccine scandal: state media

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August 21, 2018 / 3:57 AM / Updated an hour ago

China's Changchun mayor resigns after vaccine scandal: state media

BEIJING (Reuters) – The mayor of the Chinese city of Changchun resigned on Tuesday, state media reported, after a safety scandal at Changchun-based vaccine maker Changsheng Biotechnology sparked widespread consumer anger.

FILE PHOTO – People gather at the gate of Changchun Changsheng Bio-technology Co Ltd, the Chinese vaccine maker, in Changchun, China July 26, 2018. REUTERS/Philip Wen

The company was accused in July of falsifying data for a rabies vaccine and manufacturing an ineffective vaccine for babies, triggering public outrage and multiple official investigations.

The People’s Daily reported on Tuesday mayor Liu Changlong’s resignation had been accepted by the Standing Committee of Changchun’s People’s Congress. The state-run paper did not directly link Liu’s decision with the vaccine scandal.

In a separate report on Tuesday, the newspaper said the head of the Changchun Food and Drug Administration, Tang Ruodi, had been removed from his post.

China said on Saturday it had sacked six senior officials at its food and drug regulator, a day after state media reported that more than 40 government officials, including seven at the provincial level, had been held accountable for the scandal.

Changsheng is based in Changchun city in Jilin province. It is China’s second-largest producer of rabies and chickenpox vaccines, according to the company’s 2017 annual report.

The company said on its website on Friday that it had dismissed its deputy general manager in charge of production and warned or fined eight other employees.

Changsheng has said that because it would face huge fines and confiscation of all illegal income it faced the risk of delisting.

Reporting by Stella Qiu and Se Young Lee; Editing by Darren Schuettler




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Uses, Side Effects & Addiction

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Can you get addicted to benzodiazepines and cyclobenzaprine?

Benzodiazepines

Benzodiazepines or benzos are habit forming and you can become addicted to them – even if you take them as your doctor or health care professional has prescribed. People who have a history of drug or alcohol abuse are more likely to develop an addiction to these drugs. If you use these drugs over a long period of time you can develop a tolerance for them. This means that you will need higher doses of the drug to treat your health condition or disease because you’ve become tolerant of the weaker formulations of the drug. These drugs may be very effective for the treatment of several conditions, for example, anxiety and insomnia; but be careful because you can become addicted to them.

The street names for benzodiazepine drugs are “Benzos” and “Downers.” Drug addicts abuse these drugs to get “high.” They can cause addiction similar to opioids (narcotic drugs like oxycodone, morphine, hydrocodone, and fentanyl), cannabinoids (marijuana), and the club drug GHB (gamma-hydroxybutyrate).

They are commonly abused by young adolescents and young adults who crush it up and snort it, or take the tablet to get high. If you abuse this medication you may have adverse effects with symptoms include:

  • Disturbing or vivid dreams
  • Irritability
  • Hostility
  • Amnesia

Signs and symptoms that you might be addicted include:

  • Problems sleeping
  • Diarrhea
  • Vomiting
  • Nausea
  • Goose bumps
  • Uncontrollable leg movements
  • Bone and muscle pain

It is very difficult to recover from benzodiazepine addiction because these drugs change the chemistry of the brain. Contact a drug addiction treatment center if you or a loved one are suffering from a addiction. Quitting cold turkey is not likely to be successful and can be dangerous because of symptoms of withdrawal. Doctors and other health care professionals that treat addiction will formulate a taper schedule to slowly wean off the medication to reduce the severity of withdrawal symptoms during treatment.

Signs and symptoms of overdose include:

Benzodiazepine withdrawal symptoms and signs

If you stop taking these medications abruptly you may experience withdrawal symptoms that include:

  • Problems concentrating
  • Sleep problems
  • Irritability
  • Increased anxiety and tension
  • Panic attacks
  • Hand tremors
  • Dry heaving and vomiting
  • Palpitations
  • Headache
  • Muscle pain and stiffness
  • A host of perceptual changes

The severity of the withdrawal symptoms depends on amount and duration of benzodiazepine use. Withdrawal symptoms can be deadly.
These medications are classified by the Drug Enforcement Administration (DEA) as Schedule IV drugs. This means that they have a lower potential and risk of dependence than other more powerful drugs like codeine, testosterone, anabolic steroids, Vicodin (hydrocodone and acetaminophen), OxyContin (oxycodone), Adderall (amphetamine and dextroamphetamine), and Ritalin (methylphenidate).

Cyclobenzaprine

Abrupt cessation after prolonged therapy may cause withdrawal symptoms such as headaches, nausea, and weakness.



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ORBITA Group Offers Middle Ground on Stenting for Stable Angina (CME/CE)

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Medpage Today

ORBITA Group Offers Middle Ground on Stenting for Stable Angina

Study solidifies the physiological basis, suggests maximizing placebo effect

MedpageToday

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    Earn Free CME Credits by reading the latest medical news in your specialty.

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  • by Reporter, MedPage Today/CRTonline.org

Action Points

  • Stenting normalizes blood flow to boost exercise capacity in stable, single-vessel coronary artery disease (CAD).
  • Note that physiological parameters showing a significant benefit to PCI included coronary flow velocity, distal coronary pressure, systolic blood pressure, and rate-pressure product.

Stenting normalized blood flow to boost exercise capacity in patients with stable, single-vessel coronary artery disease (CAD), according to a small, unblinded but careful physiological study by the ORBITA research group.

Among 21 patients with stable angina and single-vessel disease recruited from elective PCI waiting lists, investigators saw improved responses at peak exercise immediately after the procedure, improved exercise time (+67 seconds, from 145 at baseline to 212, P<0.0001), and an 81% reduction in rate-limiting angina symptoms (P<0.001).

“Examining solely objective physiological measures during physical exercise, PCI for single-vessel stable CAD shows clear evidence of meeting all that could be demanded of a therapy for ischemia,” according to Justin Davies, MD, PhD, of the Hammersmith Hospital in London, and colleagues reporting in the Aug. 28 issue of the Journal of the American College of Cardiology.

Previously, in the blinded, sham-controlled ORBITA trial presented at the Transcatheter Cardiovascular Therapeutics meeting last year, Davies’ group revealed that PCI had a small effect on exercise tolerance that was no better than that of placebo among patients with stable CAD.

An accompanying editorial called the new study “one of the best human physiological studies demonstrating the mechanisms of benefit” from stenting.

The measured objective findings “should go a long way to restoring confidence in the physiological basis for PCI and supporting its continued use for patients with stable angina,” concluded editorialists Morton Kern, MD, and Arnold Seto, MD, MPA, both of the Veterans Administration Long Beach Health Care System in California.

Why the ORBITA investigators now say that exercise-limiting angina does improve with PCI can be attributed to a change in how they define angina, argued C. Noel Bairey Merz, MD, of Cedars-Sinai Medical Center in Los Angeles.

Importantly, ORBITA had a 1-month real-world Seattle Angina Questionnaire (SAQ) evaluation, blinded design, and no cath lab preloading of medication, she noted, versus the current study’s immediate and not validated angina measurement, unblinded design, and use of intra-arterial unfractionated heparin and intracoronary nitroglycerin before coronary angiography and physiological measurement.

“Other design flaws include lack of details regarding case selection and how these findings relate to the larger population of stable ischemic heart disease; the well-established ‘training’ effect of repeat exercise stress testing whereby subsequent testing is significantly better; the lack of reporting the before and after exercise stress ECG results; and the lack of baseline and 1-month SAQ scores,” Bairey Merz said in an interview.

A better study would be needed to address issues raised of the futility of PCI for angina raised by the ORBITA trial, she emphasized. “Our physicians and patients deserve rigorous study designs.”

Patients in this study were recruited from Hammersmith Hospital and the Essex Cardiothoracic Centre in England. Mean age was 60.3 years and 19 of the 21 participants were men.

The group exercised on a supine bicycle before and after PCI until rate-limiting angina or exhaustion, while operators simultaneously took trans-stenotic coronary pressure-flow measurements.

Physiological parameters showing a significant benefit to PCI included coronary flow velocity, distal coronary pressure, systolic blood pressure, and rate-pressure product.

PCI reduced ischemia as shown by pre- versus post-procedure measures of the following:

  • Fractional flow reserve (0.59 to 0.91, P<0.001)
  • Instantaneous wave-free ratio value (0.61 to 0.96, P<0.001)
  • Coronary flow reserve value (1.7 to 3.1, P<0.001)

“These data demonstrate that PCI immediately normalizes the physiological response to exercise in coronary, microcirculatory, and systemic circulations,” Davies and colleagues said, adding that these findings were tied to stenosis resistance being eliminated immediately after PCI.

However, they acknowledged that patients’ awareness of having received PCI may have contributed a placebo effect.

“The reason that we did not blind patients in this study is that the blinding protocol in ORBITA (which was enrolling concurrently) necessitated sedation for allocation concealment, and this would have impaired exercise performance,” the authors noted.

While the authors argued that their selection of focal single-vessel disease as anatomy and physiology likely to be normalized by PCI, the editorialists argued that it made the findings less generalizable.

It is still possible that “stenting may not be able to relieve ischemia/angina because of the confounding influences of untreatable small-branch disease, coexistent microvascular dysfunction, or in patients with prior remote MI, residual ischemia in the border zones,” Kern and Seto wrote.

In any case, these scenarios do not negate PCI’s therapeutic effect, they maintained.

The researchers posited that ORBITA and the new findings together may have a message for practice: Take advantage of the placebo effect in everyday clinical practice in which every patient is aware of the stent received.

“As clinicians, we should feel confident about the biological plausibility of PCI as an effective therapy for the relief of angina; however, we should also be aware that patients also gain some functional improvement from placebo,” they wrote.

Emphasizing to the patient how effective the PCI has been, both anatomically and physiologically, such as by showing the pre- and post-PCI angiogram images might not only enhance overall patient education, they noted, but also “maximize the overall therapeutic benefit of PCI in stable angina.”

The study was funded by the National Institute for Health Research and Imperial College Healthcare NHS Trust Biomedical Research Centre.

Davies and several co-authors disclosed relationships with industry including Philips Volcano, Pfizer, AstraZeneca, and others.

Kern disclosed having been a consultant and speaker for Abbott/St. Jude, Philips Volcano, Acist Medical, Opsens, and HeartFlow.

Seto reported being a speaker for and receiving research funding from Acist Medical and Philips Volcano.

Bairey Merz declared no conflicting interests.

  • Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
1969-12-31T19:00:00-0500

last updated

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At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.

Medpage Today

ORBITA Group Offers Middle Ground on Stenting for Stable Angina

Study solidifies the physiological basis, suggests maximizing placebo effect

MedpageToday

  • register today

    Earn Free CME Credits by reading the latest medical news in your specialty.

    sign up

  • by Reporter, MedPage Today/CRTonline.org

Action Points

  • Stenting normalizes blood flow to boost exercise capacity in stable, single-vessel coronary artery disease (CAD).
  • Note that physiological parameters showing a significant benefit to PCI included coronary flow velocity, distal coronary pressure, systolic blood pressure, and rate-pressure product.

Stenting normalized blood flow to boost exercise capacity in patients with stable, single-vessel coronary artery disease (CAD), according to a small, unblinded but careful physiological study by the ORBITA research group.

Among 21 patients with stable angina and single-vessel disease recruited from elective PCI waiting lists, investigators saw improved responses at peak exercise immediately after the procedure, improved exercise time (+67 seconds, from 145 at baseline to 212, P<0.0001), and an 81% reduction in rate-limiting angina symptoms (P<0.001).

"Examining solely objective physiological measures during physical exercise, PCI for single-vessel stable CAD shows clear evidence of meeting all that could be demanded of a therapy for ischemia," according to Justin Davies, MD, PhD, of the Hammersmith Hospital in London, and colleagues reporting in the Aug. 28 issue of the Journal of the American College of Cardiology.

Previously, in the blinded, sham-controlled ORBITA trial presented at the Transcatheter Cardiovascular Therapeutics meeting last year, Davies' group revealed that PCI had a small effect on exercise tolerance that was no better than that of placebo among patients with stable CAD.

An accompanying editorial called the new study "one of the best human physiological studies demonstrating the mechanisms of benefit" from stenting.

The measured objective findings "should go a long way to restoring confidence in the physiological basis for PCI and supporting its continued use for patients with stable angina," concluded editorialists Morton Kern, MD, and Arnold Seto, MD, MPA, both of the Veterans Administration Long Beach Health Care System in California.

Why the ORBITA investigators now say that exercise-limiting angina does improve with PCI can be attributed to a change in how they define angina, argued C. Noel Bairey Merz, MD, of Cedars-Sinai Medical Center in Los Angeles.

Importantly, ORBITA had a 1-month real-world Seattle Angina Questionnaire (SAQ) evaluation, blinded design, and no cath lab preloading of medication, she noted, versus the current study's immediate and not validated angina measurement, unblinded design, and use of intra-arterial unfractionated heparin and intracoronary nitroglycerin before coronary angiography and physiological measurement.

"Other design flaws include lack of details regarding case selection and how these findings relate to the larger population of stable ischemic heart disease; the well-established 'training' effect of repeat exercise stress testing whereby subsequent testing is significantly better; the lack of reporting the before and after exercise stress ECG results; and the lack of baseline and 1-month SAQ scores," Bairey Merz said in an interview.

A better study would be needed to address issues raised of the futility of PCI for angina raised by the ORBITA trial, she emphasized. "Our physicians and patients deserve rigorous study designs."

Patients in this study were recruited from Hammersmith Hospital and the Essex Cardiothoracic Centre in England. Mean age was 60.3 years and 19 of the 21 participants were men.

The group exercised on a supine bicycle before and after PCI until rate-limiting angina or exhaustion, while operators simultaneously took trans-stenotic coronary pressure-flow measurements.

Physiological parameters showing a significant benefit to PCI included coronary flow velocity, distal coronary pressure, systolic blood pressure, and rate-pressure product.

PCI reduced ischemia as shown by pre- versus post-procedure measures of the following:

  • Fractional flow reserve (0.59 to 0.91, P<0.001)
  • Instantaneous wave-free ratio value (0.61 to 0.96, P<0.001)
  • Coronary flow reserve value (1.7 to 3.1, P<0.001)

"These data demonstrate that PCI immediately normalizes the physiological response to exercise in coronary, microcirculatory, and systemic circulations," Davies and colleagues said, adding that these findings were tied to stenosis resistance being eliminated immediately after PCI.

However, they acknowledged that patients' awareness of having received PCI may have contributed a placebo effect.

"The reason that we did not blind patients in this study is that the blinding protocol in ORBITA (which was enrolling concurrently) necessitated sedation for allocation concealment, and this would have impaired exercise performance," the authors noted.

While the authors argued that their selection of focal single-vessel disease as anatomy and physiology likely to be normalized by PCI, the editorialists argued that it made the findings less generalizable.

It is still possible that "stenting may not be able to relieve ischemia/angina because of the confounding influences of untreatable small-branch disease, coexistent microvascular dysfunction, or in patients with prior remote MI, residual ischemia in the border zones," Kern and Seto wrote.

In any case, these scenarios do not negate PCI's therapeutic effect, they maintained.

The researchers posited that ORBITA and the new findings together may have a message for practice: Take advantage of the placebo effect in everyday clinical practice in which every patient is aware of the stent received.

"As clinicians, we should feel confident about the biological plausibility of PCI as an effective therapy for the relief of angina; however, we should also be aware that patients also gain some functional improvement from placebo," they wrote.

Emphasizing to the patient how effective the PCI has been, both anatomically and physiologically, such as by showing the pre- and post-PCI angiogram images might not only enhance overall patient education, they noted, but also "maximize the overall therapeutic benefit of PCI in stable angina."

The study was funded by the National Institute for Health Research and Imperial College Healthcare NHS Trust Biomedical Research Centre.

Davies and several co-authors disclosed relationships with industry including Philips Volcano, Pfizer, AstraZeneca, and others.

Kern disclosed having been a consultant and speaker for Abbott/St. Jude, Philips Volcano, Acist Medical, Opsens, and HeartFlow.

Seto reported being a speaker for and receiving research funding from Acist Medical and Philips Volcano.

Bairey Merz declared no conflicting interests.

  • Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
1969-12-31T19:00:00-0500

last updated

Take Posttest Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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Black Lung Disease Sees Significant Resurgence

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Medpage Today

Black Lung Disease Sees Significant Resurgence

Central Appalachia epicenter of progressive massive fibrosis cases

MedpageToday

Reported cases of the most aggressive and deadly form of black lung disease increased sharply during the past 2 decades, despite large declines in the number of coal miners working in the U.S. during the period, according to researchers.

Analysis of data collected by the U.S. Department of Labor from 1970 to 2016 under the Federal Black Lung Program identified 4,679 cases of progressive massive fibrosis (PMF). A total of 2,374 cases were identified during the 21-year period between 1996 and 2016, surpassing the 2,205 cases identified during the first 26 years of the program, reported Kirsten Almberg, PhD, of the University of Illinois Chicago and National Institute for Occupational Safety and Health (NIOSH), and colleagues.

The increases occurred despite the fact that the number of coal miners working in the U.S. declined by more than two-thirds between 1979 and 2016, they noted in the Annals of the American Thoracic Society.

While the PMF case totals were reported at the 2018 American Thoracic Society meeting in San Diego, Almberg told MedPage Today that the full report provides new information about PMF trends.

The analysis revealed that more than four out of five (84%) PMF cases reported from 1970 to 2016 occurred among miners working in central Appalachia, with 28.4% of cases occurring in West Virginia, 20.2% occurring in Kentucky, 20.0% occurring in Pennsylvania, and 15.3% occurring in Virginia.

The biggest increase in PMF cases by state occurred in Virginia, with an average increase of 31.5% annually over the study period.

Miners and former miners reporting PMF ranged in age from 27 to 93 years, and the average age was 61 years.

“We believe what’s driving this increase, especially in central Appalachia, is overexposure to dust and changes in mining practices that produce finer dust particles and may also alter the mineralogic characteristics of that dust,” Almberg said. “The leading hypothesis is that there has been higher exposure to silica in recent decades, which is more toxic to the lungs.”

Current mining practices, such as surface mining, typically expose miners to high levels of rock dust, including crystalline silica dust. Since it has become profitable to sort coal from rock in recent decades, this is increasingly part of the mining process.

Almberg told MedPage Today that reductions in allowable dust exposures in U.S. coal mines, which went into effect in 2014, should have a positive impact on PMF cases moving forward if mining companies fully comply with the regulations.

“With the reduction in permissible dust levels we would expect to see decreases in all [black lung] disease categories — both simple and severe — but only time will tell,” she said. “This is why it will be important to maintain rigorous surveillance programs that include both active and former coal miners.”

A recent indictment brought against eight former employees of a now bankrupt coal mining company in Kentucky illustrates the potential ongoing threat to workers.

The indictment by the Western Kentucky District U.S. Attorney charged the employees of Armstrong Energy coal company with falsifying dust monitoring samples in two of its mines, placing dust monitors in clean rooms instead of mining areas, and engaging in other practices designed to circumvent federal restrictions on coal dust exposures.

“What the grand jury is charging and what the United States will prosecute is lying and cheating by a coal company to prevent the appropriate testing of this dust to protect miners,” U.S. Attorney Russell Coleman said at a July 11 press conference in Owensboro, Kentucky.

The study was funded by NIOSH and the Alpha Foundation for the Improvement of Mining Safety and Health.

2018-08-20T17:00:00-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.

Medpage Today

Black Lung Disease Sees Significant Resurgence

Central Appalachia epicenter of progressive massive fibrosis cases

MedpageToday

Reported cases of the most aggressive and deadly form of black lung disease increased sharply during the past 2 decades, despite large declines in the number of coal miners working in the U.S. during the period, according to researchers.

Analysis of data collected by the U.S. Department of Labor from 1970 to 2016 under the Federal Black Lung Program identified 4,679 cases of progressive massive fibrosis (PMF). A total of 2,374 cases were identified during the 21-year period between 1996 and 2016, surpassing the 2,205 cases identified during the first 26 years of the program, reported Kirsten Almberg, PhD, of the University of Illinois Chicago and National Institute for Occupational Safety and Health (NIOSH), and colleagues.

The increases occurred despite the fact that the number of coal miners working in the U.S. declined by more than two-thirds between 1979 and 2016, they noted in the Annals of the American Thoracic Society.

While the PMF case totals were reported at the 2018 American Thoracic Society meeting in San Diego, Almberg told MedPage Today that the full report provides new information about PMF trends.

The analysis revealed that more than four out of five (84%) PMF cases reported from 1970 to 2016 occurred among miners working in central Appalachia, with 28.4% of cases occurring in West Virginia, 20.2% occurring in Kentucky, 20.0% occurring in Pennsylvania, and 15.3% occurring in Virginia.

The biggest increase in PMF cases by state occurred in Virginia, with an average increase of 31.5% annually over the study period.

Miners and former miners reporting PMF ranged in age from 27 to 93 years, and the average age was 61 years.

"We believe what's driving this increase, especially in central Appalachia, is overexposure to dust and changes in mining practices that produce finer dust particles and may also alter the mineralogic characteristics of that dust," Almberg said. "The leading hypothesis is that there has been higher exposure to silica in recent decades, which is more toxic to the lungs."

Current mining practices, such as surface mining, typically expose miners to high levels of rock dust, including crystalline silica dust. Since it has become profitable to sort coal from rock in recent decades, this is increasingly part of the mining process.

Almberg told MedPage Today that reductions in allowable dust exposures in U.S. coal mines, which went into effect in 2014, should have a positive impact on PMF cases moving forward if mining companies fully comply with the regulations.

"With the reduction in permissible dust levels we would expect to see decreases in all [black lung] disease categories -- both simple and severe -- but only time will tell," she said. "This is why it will be important to maintain rigorous surveillance programs that include both active and former coal miners."

A recent indictment brought against eight former employees of a now bankrupt coal mining company in Kentucky illustrates the potential ongoing threat to workers.

The indictment by the Western Kentucky District U.S. Attorney charged the employees of Armstrong Energy coal company with falsifying dust monitoring samples in two of its mines, placing dust monitors in clean rooms instead of mining areas, and engaging in other practices designed to circumvent federal restrictions on coal dust exposures.

"What the grand jury is charging and what the United States will prosecute is lying and cheating by a coal company to prevent the appropriate testing of this dust to protect miners," U.S. Attorney Russell Coleman said at a July 11 press conference in Owensboro, Kentucky.

The study was funded by NIOSH and the Alpha Foundation for the Improvement of Mining Safety and Health.

2018-08-20T17:00:00-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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Anticonvulsant With Opioids Tied To Higher Mortality (CME/CE)

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Medpage Today

Anticonvulsant With Opioids Tied To Higher Mortality

Researchers call for warning labels about combining pregabalin and opioids

MedpageToday

  • register today

    Earn Free CME Credits by reading the latest medical news in your specialty.

    sign up

  • by Contributing Writer, MedPage Today

Action Points

  • Treatment with pregabalin (Lyrica) was associated with an increased risk for opioid-related death when co-prescribed with opioids.
  • Note that FDA reports suggest the number of patients receiving gabapentinoids with opioid analgesics or benzodiazepines has increased, with more than half of patients concurrently dispensed both a gabapentinoid and an opioid analgesic.

Treatment with pregabalin (Lyrica), an anticonvulsant also approved for several forms of chronic pain, was associated with an increased risk for opioid-related death when co-prescribed with opioids, Canadian researchers reported.

Among some 6,500 residents of Ontario with opioid prescriptions — including 1,417 who subsequently died from an opioid-related cause — concomitant exposure to pregabalin and opioids was associated with significantly increased odds of opioid-related death compared with exposure to opioids alone (adjusted OR 1.68, 95% CI 1.19-2.36), reported Tara Gomes, MHSc, PhD, of the Institute for Clinical Evaluative Sciences (ICES) and St. Michael’s Hospital in Toronto, and colleagues.

A high dose of pregabalin (defined as >300 mg/d) was associated with substantially increased odds of opioid-related death relative to no pregabalin exposure (adjusted OR 2.51, 95% CI 1.24-5.06). A low or moderate dose (≤300 mg/d) was associated with relatively lower, but still significantly increased, odds of opioid-related death (adjusted OR 1.52, 95% CI 1.04-2.22), they wrote in the Annals of Internal Medicine.

Pregabalin and opioids may lead to a potentially life-threatening interaction similar to one previously observed with gabapentin (Neurontin) and opioids, the researchers suggested.

Pregabalin can be sedating and may augment central nervous system (CNS) depression in patients receiving opioids. “There is an important drug interaction between opioids and pregabalin that can lead to increased risk of fatal overdose, particularly at high doses of pregabalin,” Gomes told MedPage Today. “Clinicians should consider carefully whether to prescribe opioids and pregabalin together. If they decide that both medications are clinically appropriate, they should start with low doses and monitor their patients closely.”

Pregabalin ranked as one of the 10 best-selling drugs in 2017, and the use of gabapentinoids (gabapentin and pregabalin) tripled in the U.S. from 2002 to 2015.

New prescribing patterns “as healthcare practitioners begin to explore new pain management paradigms” in response to the opioid crisis may have led to this increase, observed Douglas Throckmorton, MD, and Janet Woodcock, MD, both of the FDA in Silver Spring, Maryland, in an accompanying editorial.

“These drugs are approved to treat certain forms of neuropathic pain and seizures, and pregabalin is approved to treat fibromyalgia. Increased clinical use, much of which seems to be for painful conditions beyond the approved indications, has recently been linked to higher rates of misuse and abuse,” they wrote.

FDA reports suggest the number of patients receiving gabapentinoids with opioid analgesics or benzodiazepines has increased, with more than half of patients concurrently dispensed both a gabapentinoid and an opioid analgesic, added Throckmorton and Woodcock. “Clinicians who may seek to minimize opioid dosing by co-prescribing alternative medications could thus be inadvertently introducing new risks,” they said.

Because more than half of Ontario residents who start pregabalin therapy also are prescribed an opioid, this research has important clinical implications, Gomes noted.

“Currently the product monograph for pregabalin does not include a warning regarding its use with opioids,” she said. “In contrast, this warning does exist for gabapentin, another drug within this class. Given this emerging evidence, regulators should consider requiring a similar warning for pregabalin.”

From a regulatory perspective, more research about the consequences of combining CNS-active drugs is needed, Throckmorton and Woodcock noted. “The U.S. Food and Drug Administration is implementing processes to support such work and engaging in initiatives to determine what changes, if any, are needed to address the labeling concerns raised by Gomes and colleagues,” they wrote.

“As we move forward in this work, we need to keep in mind that both gabapentinoids and opioids have an appropriate role in pain management,” they noted. “As we work to better understand potential interactions, we also need to try to avoid inadvertently increasing prescription drug use or abuse through future regulatory actions.”

The study included Ontario residents, ages 15 to 105, who received publicly-funded opioid prescriptions from August 1997 to December 2016. The 1,417 who died of opioid-related causes (cases) were matched by age, sex, and other characteristics to 5,097 surviving individuals also receiving opioids (controls). Case patients were more likely to have recently been prescribed other CNS depressants, receive more medications annually, and have more comorbidities than control participants. Statistical results reflected multivariable adjustment.

The study was supported by the Ontario Ministry of Health and Long-Term Care.

Gomes and co-authors disclosed relevant relationships with Lundbeck, Indivior, Mundipharma, Opiant, D&A Pharma, BioProject, Kinnov Therapeutics, Novartis, Eli Lilly, Novo Nordisk, Allergan, and Celgene.

Throckmorton is the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research (CDER). Woodcock is the CDER director. They disclosed no relevant relationships with industry.

  • Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
2018-08-20T17:30:00-0400
Take Posttest Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.

Medpage Today

Anticonvulsant With Opioids Tied To Higher Mortality

Researchers call for warning labels about combining pregabalin and opioids

MedpageToday

  • register today

    Earn Free CME Credits by reading the latest medical news in your specialty.

    sign up

  • by Contributing Writer, MedPage Today

Action Points

  • Treatment with pregabalin (Lyrica) was associated with an increased risk for opioid-related death when co-prescribed with opioids.
  • Note that FDA reports suggest the number of patients receiving gabapentinoids with opioid analgesics or benzodiazepines has increased, with more than half of patients concurrently dispensed both a gabapentinoid and an opioid analgesic.

Treatment with pregabalin (Lyrica), an anticonvulsant also approved for several forms of chronic pain, was associated with an increased risk for opioid-related death when co-prescribed with opioids, Canadian researchers reported.

Among some 6,500 residents of Ontario with opioid prescriptions -- including 1,417 who subsequently died from an opioid-related cause -- concomitant exposure to pregabalin and opioids was associated with significantly increased odds of opioid-related death compared with exposure to opioids alone (adjusted OR 1.68, 95% CI 1.19-2.36), reported Tara Gomes, MHSc, PhD, of the Institute for Clinical Evaluative Sciences (ICES) and St. Michael's Hospital in Toronto, and colleagues.

A high dose of pregabalin (defined as >300 mg/d) was associated with substantially increased odds of opioid-related death relative to no pregabalin exposure (adjusted OR 2.51, 95% CI 1.24-5.06). A low or moderate dose (≤300 mg/d) was associated with relatively lower, but still significantly increased, odds of opioid-related death (adjusted OR 1.52, 95% CI 1.04-2.22), they wrote in the Annals of Internal Medicine.

Pregabalin and opioids may lead to a potentially life-threatening interaction similar to one previously observed with gabapentin (Neurontin) and opioids, the researchers suggested.

Pregabalin can be sedating and may augment central nervous system (CNS) depression in patients receiving opioids. "There is an important drug interaction between opioids and pregabalin that can lead to increased risk of fatal overdose, particularly at high doses of pregabalin," Gomes told MedPage Today. "Clinicians should consider carefully whether to prescribe opioids and pregabalin together. If they decide that both medications are clinically appropriate, they should start with low doses and monitor their patients closely."

Pregabalin ranked as one of the 10 best-selling drugs in 2017, and the use of gabapentinoids (gabapentin and pregabalin) tripled in the U.S. from 2002 to 2015.

New prescribing patterns "as healthcare practitioners begin to explore new pain management paradigms" in response to the opioid crisis may have led to this increase, observed Douglas Throckmorton, MD, and Janet Woodcock, MD, both of the FDA in Silver Spring, Maryland, in an accompanying editorial.

"These drugs are approved to treat certain forms of neuropathic pain and seizures, and pregabalin is approved to treat fibromyalgia. Increased clinical use, much of which seems to be for painful conditions beyond the approved indications, has recently been linked to higher rates of misuse and abuse," they wrote.

FDA reports suggest the number of patients receiving gabapentinoids with opioid analgesics or benzodiazepines has increased, with more than half of patients concurrently dispensed both a gabapentinoid and an opioid analgesic, added Throckmorton and Woodcock. "Clinicians who may seek to minimize opioid dosing by co-prescribing alternative medications could thus be inadvertently introducing new risks," they said.

Because more than half of Ontario residents who start pregabalin therapy also are prescribed an opioid, this research has important clinical implications, Gomes noted.

"Currently the product monograph for pregabalin does not include a warning regarding its use with opioids," she said. "In contrast, this warning does exist for gabapentin, another drug within this class. Given this emerging evidence, regulators should consider requiring a similar warning for pregabalin."

From a regulatory perspective, more research about the consequences of combining CNS-active drugs is needed, Throckmorton and Woodcock noted. "The U.S. Food and Drug Administration is implementing processes to support such work and engaging in initiatives to determine what changes, if any, are needed to address the labeling concerns raised by Gomes and colleagues," they wrote.

"As we move forward in this work, we need to keep in mind that both gabapentinoids and opioids have an appropriate role in pain management," they noted. "As we work to better understand potential interactions, we also need to try to avoid inadvertently increasing prescription drug use or abuse through future regulatory actions."

The study included Ontario residents, ages 15 to 105, who received publicly-funded opioid prescriptions from August 1997 to December 2016. The 1,417 who died of opioid-related causes (cases) were matched by age, sex, and other characteristics to 5,097 surviving individuals also receiving opioids (controls). Case patients were more likely to have recently been prescribed other CNS depressants, receive more medications annually, and have more comorbidities than control participants. Statistical results reflected multivariable adjustment.

The study was supported by the Ontario Ministry of Health and Long-Term Care.

Gomes and co-authors disclosed relevant relationships with Lundbeck, Indivior, Mundipharma, Opiant, D&A Pharma, BioProject, Kinnov Therapeutics, Novartis, Eli Lilly, Novo Nordisk, Allergan, and Celgene.

Throckmorton is the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research (CDER). Woodcock is the CDER director. They disclosed no relevant relationships with industry.

  • Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
2018-08-20T17:30:00-0400
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Major Boost in Viral Suppression Rates in HIV Patients in U.S.

0


Medpage Today

Major Boost in Viral Suppression Rates in HIV Patients in U.S.

But disparities among younger and black HIV-positive people remain

MedpageToday

  • by Staff Writer, MedPage Today

There was a nearly three-fold improvement in the rate of HIV viral suppression among people in the U.S. living with HIV who received clinical care, although odds of improvement varied among different demographic groups, researchers found.

Viral suppression rose from 32% in 1997 to 86% in 2015, and in adjusted analyses, factors such as older age (OR 0.76 per decade, 95% CI 0.74-0.78) and using an integrase strand transfer inhibitor (ISTI)-based regimen (OR 0.54, 95% CI 0.51-0.57, P<0.001 for both) were linked with lower odds of detectable viral load, reported Heidi M. Crane, MD, of the University of Washington in Seattle, and colleagues.

However, adjusted analyses also found that black race was associated with higher odds of having a detectable viral load (adjusted OR 1.68, 95% CI 1.57-1.80, P<0.001), they wrote in the Annals of Internal Medicine.

They noted that large-scale estimates of viral suppression from across the U.S. are “limited,” and that other analyses from earlier time periods did not examine potential improvements in viral suppression, due to recent changes in antiretroviral therapy (ART) regimens. The authors also cited the increased use of ISTIs, stating that these drugs “may have superior tolerability, reduced pill burden, and improved virologic and immune outcomes.”

Researchers examined data from the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS), a cohort of more than 32,000 people living with HIV with two or more HIV clinical care visits at eight U.S. sites. Participants were ages ≥18, with a viral load measure between 1997 and 2015, as well as a subgroup of those who received ART in or after 2010 “to minimize the effect of changes in treatment initiation guidelines.” Viral suppression was defined as a viral load of no more than 400 copies/mL (versus >400 copies/mL).

Overall, 47% were still alive and receiving clinical care at the end of the study period, over 80% were men, and 55% were “non-white.” Those with viral suppression were older (age 46 versus 41) and more likely to have a current CD4 count of ≥0.500 × 109 cells/L (58% versus 22%, P<0.001 for both) compared to those without viral suppression.

Adjusted analyses found that older age, use of ISTI-based regimens, Hispanic ethnicity (OR 0.81, 95% CI 0.74-0.90), calendar time (OR 0.83, 95% CI 0.83-0.84), and years of follow-up (OR 0.79, 95% CI 0.79-0.80) were all associated with lower odds of a detectable viral load (P<0.001 for each).

In the subgroup analyses of about 20,000 people living with HIV who received ART from 2010 to 2015 (the “current treatment era”), the authors found the percentage receiving this therapy increased each year (86% in 2010 to 93% in 2015). About 18% of people living with HIV reported current illicit drug use each year (from 2010 to 2015). The authors also noted that the findings in the initial adjusted analyses persisted in analyses limited to 2010 and after.

In an accompanying editorial, Anthony S. Fauci, MD, of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, and colleagues, noted the demographic disparities in these results, but added there was “cause for optimism” because specific improvements in this demographic group “have approached those of older age groups in recent years.”

“As guidelines have changed, therapies have improved, and other efforts have been instituted to improve care, the rates of viral suppression have continued to increase proportionately for all racial groups,” the editorialists wrote.

However, they added that the association between black race and detectable viral load compared with other racial groups still persists, and should be investigated.

“Identifying and understanding disparities in achieving viral suppression is the first step in addressing them with targeted interventions,” Fauci’s group stated.

Study limitations included the observational nature of the data, “particularly with regard to causal inference,” the authors said. They added that the adherence measure was self-reported, and accuracy may have “varied across demographic groups.”

The study was supported by the National Institute on Alcohol Abuse and Alcoholism, NIAID, National Institute of General Medical Sciences, and National Institute on Drug Abuse.

Crane disclosed support from ViiV Healthcare. Co-authors disclosed support from Pfizer, Gilead Sciences, ViiV Healthcare, Gilead Foundation, Bristol-Myers Squibb, Roche, Janssen Pharmaceutical, Medscape, Merck, AbbVie, and Proteus.

Fauci and co-authors disclosed no relevant relationships with industry.

2018-08-20T17:47:11-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.

Medpage Today

Major Boost in Viral Suppression Rates in HIV Patients in U.S.

But disparities among younger and black HIV-positive people remain

MedpageToday

  • by Staff Writer, MedPage Today

There was a nearly three-fold improvement in the rate of HIV viral suppression among people in the U.S. living with HIV who received clinical care, although odds of improvement varied among different demographic groups, researchers found.

Viral suppression rose from 32% in 1997 to 86% in 2015, and in adjusted analyses, factors such as older age (OR 0.76 per decade, 95% CI 0.74-0.78) and using an integrase strand transfer inhibitor (ISTI)-based regimen (OR 0.54, 95% CI 0.51-0.57, P<0.001 for both) were linked with lower odds of detectable viral load, reported Heidi M. Crane, MD, of the University of Washington in Seattle, and colleagues.

However, adjusted analyses also found that black race was associated with higher odds of having a detectable viral load (adjusted OR 1.68, 95% CI 1.57-1.80, P<0.001), they wrote in the Annals of Internal Medicine.

They noted that large-scale estimates of viral suppression from across the U.S. are "limited," and that other analyses from earlier time periods did not examine potential improvements in viral suppression, due to recent changes in antiretroviral therapy (ART) regimens. The authors also cited the increased use of ISTIs, stating that these drugs "may have superior tolerability, reduced pill burden, and improved virologic and immune outcomes."

Researchers examined data from the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS), a cohort of more than 32,000 people living with HIV with two or more HIV clinical care visits at eight U.S. sites. Participants were ages ≥18, with a viral load measure between 1997 and 2015, as well as a subgroup of those who received ART in or after 2010 "to minimize the effect of changes in treatment initiation guidelines." Viral suppression was defined as a viral load of no more than 400 copies/mL (versus >400 copies/mL).

Overall, 47% were still alive and receiving clinical care at the end of the study period, over 80% were men, and 55% were "non-white." Those with viral suppression were older (age 46 versus 41) and more likely to have a current CD4 count of ≥0.500 × 109 cells/L (58% versus 22%, P<0.001 for both) compared to those without viral suppression.

Adjusted analyses found that older age, use of ISTI-based regimens, Hispanic ethnicity (OR 0.81, 95% CI 0.74-0.90), calendar time (OR 0.83, 95% CI 0.83-0.84), and years of follow-up (OR 0.79, 95% CI 0.79-0.80) were all associated with lower odds of a detectable viral load (P<0.001 for each).

In the subgroup analyses of about 20,000 people living with HIV who received ART from 2010 to 2015 (the "current treatment era"), the authors found the percentage receiving this therapy increased each year (86% in 2010 to 93% in 2015). About 18% of people living with HIV reported current illicit drug use each year (from 2010 to 2015). The authors also noted that the findings in the initial adjusted analyses persisted in analyses limited to 2010 and after.

In an accompanying editorial, Anthony S. Fauci, MD, of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, and colleagues, noted the demographic disparities in these results, but added there was "cause for optimism" because specific improvements in this demographic group "have approached those of older age groups in recent years."

"As guidelines have changed, therapies have improved, and other efforts have been instituted to improve care, the rates of viral suppression have continued to increase proportionately for all racial groups," the editorialists wrote.

However, they added that the association between black race and detectable viral load compared with other racial groups still persists, and should be investigated.

"Identifying and understanding disparities in achieving viral suppression is the first step in addressing them with targeted interventions," Fauci's group stated.

Study limitations included the observational nature of the data, "particularly with regard to causal inference," the authors said. They added that the adherence measure was self-reported, and accuracy may have "varied across demographic groups."

The study was supported by the National Institute on Alcohol Abuse and Alcoholism, NIAID, National Institute of General Medical Sciences, and National Institute on Drug Abuse.

Crane disclosed support from ViiV Healthcare. Co-authors disclosed support from Pfizer, Gilead Sciences, ViiV Healthcare, Gilead Foundation, Bristol-Myers Squibb, Roche, Janssen Pharmaceutical, Medscape, Merck, AbbVie, and Proteus.

Fauci and co-authors disclosed no relevant relationships with industry.

2018-08-20T17:47:11-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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This Is Your Brain on a Long ED Shift: HealthLeaders Media

0


Medpage Today

This Is Your Brain on a Long ED Shift: HealthLeaders Media

Also, strategies to enhance in-hospital patient mobility

MedpageToday

  • by

Working a 24-hour shift in the emergency department can affect a doctor’s cognitive function, according to a recent analysis.

A new study revealed that doctors issued fewer opioid prescriptions after hearing about a patient’s overdose death.

The majority of healthcare providers believe population health should be a priority for their organization, a recent survey found.

Here are five strategies for enhancing a patient’s mobility during a hospital stay.

This report is brought to you by HealthLeaders Media.

2018-08-20T18:00:00-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.

Medpage Today

This Is Your Brain on a Long ED Shift: HealthLeaders Media

Also, strategies to enhance in-hospital patient mobility

MedpageToday

  • by

Working a 24-hour shift in the emergency department can affect a doctor's cognitive function, according to a recent analysis.

A new study revealed that doctors issued fewer opioid prescriptions after hearing about a patient's overdose death.

The majority of healthcare providers believe population health should be a priority for their organization, a recent survey found.

Here are five strategies for enhancing a patient's mobility during a hospital stay.

This report is brought to you by HealthLeaders Media.

2018-08-20T18:00:00-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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Azar Asks Congress, Pharma to Do More to Cut Drug Prices

0


Medpage Today

Azar Asks Congress, Pharma to Do More to Cut Drug Prices

Also urges industry to list prices in direct-to-consumer ads

MedpageToday

  • by News Editor, MedPage Today

WASHINGTON — Congress and drugmakers should be doing more to lower the cost of prescription drugs, Health and Human Services (HHS) Secretary Alex Azar said Monday on a conference call with reporters.

“The industry and Congress can and should take specific action in the months to come,” said Azar. For example, “The industry could move further to a fixed price discount system at the point of sale. There’s nothing stopping them. There’s nothing stopping pharmacy benefit managers [PBMs] from changing the contracts they have with their plans or their employers to enable discount pricing or to move to net pricing regimes and away from guaranteed rebate structures that lock in existing incentives toward ever higher list prices.”

“The pharmaceutical industry can and should voluntarily begin disclosing the cost of their drugs in direct-to-consumer advertising,” he continued. “Congress can and should act to preclude ‘gag clauses’ in private insurance as well as Medicare.” Azar was referring to contract clauses that prohibit pharmacists from letting customers know when it would be cheaper to pay for a drug out-of-pocket than to go through their insurance.

“Congress can and should repeal the Obamacare giveaway to pharma by limiting the rebates in the Medicaid program for those actors who increase list prices faster than the rate of inflation, and Congress can and should act to get rid of the abuse of the 180-day generic exclusivity window currently being abused by generic and branded pharmaceutical companies to delay entry of competitive generic products,” he added.

Azar’s remarks came during a call that the agency convened to mark 100 days since President Trump released his plan to lower prescription drug costs for patients. “We have taken a significant amount of action in these 100 days, but this is just the beginning of a fundamental transformation,” he said.

Azar cited actions the administration had taken in this area, including accelerating generic drug approvals, launching a work-group to consider ways to safely import certain sole-source branded drugs, launching a biosimilars action program, and publicizing companies who had used the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program to deny access to generic companies requesting samples of brand-name drugs for the purpose of developing generic versions.

He also lauded drugmakers for their actions so far. “Fifteen companies have made significant announcements on drug prices by either reducing prices … or freezing prices at least,” he said. “And a new analysis from the [HHS] Assistant Secretary for Planning and Evaluation finds that there have been 60% fewer brand-name price increases than the same period in 2017, and 54% more brand-name and generic price decreases.”

However, some media outlets have reported that the drug companies’ announcements were “largely symbolic” and would not greatly affect the companies’ bottom lines. “Of the few companies that actually cut prices, for instance, most targeted old products that no longer produce much revenue — such as Merck’s 60% discount to a hepatitis C medicine that had no U.S. revenues in the first quarter,” Politico noted in its story on the topic. “Others volunteered to halt price increases for 6 months — in some cases, just weeks after announcing what is normally their last price hike for the year.”

When asked by MedPage Today about this, Dan Best, the secretary’s senior advisor for drug pricing reform, responded that “Our focus is getting the work done that we laid out in the blueprint; how manufacturers have decided to support or go in this direction — it’s something we’re appreciative of. It does have an impact on what consumers would pay, but at the end of the day, the only way we’re going to achieve our objective is to deliver on the blueprint as outlined on May 11th.”

Congressional Democrats are also talking about the topic — but in a different light. On Tuesday, Senate Democrats are holding an event featuring patients and their families who have been adversely affected by high prescription drug prices.

1969-12-31T19:00:00-0500

last updated

Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.

Medpage Today

Azar Asks Congress, Pharma to Do More to Cut Drug Prices

Also urges industry to list prices in direct-to-consumer ads

MedpageToday

  • by News Editor, MedPage Today

WASHINGTON -- Congress and drugmakers should be doing more to lower the cost of prescription drugs, Health and Human Services (HHS) Secretary Alex Azar said Monday on a conference call with reporters.

"The industry and Congress can and should take specific action in the months to come," said Azar. For example, "The industry could move further to a fixed price discount system at the point of sale. There's nothing stopping them. There's nothing stopping pharmacy benefit managers [PBMs] from changing the contracts they have with their plans or their employers to enable discount pricing or to move to net pricing regimes and away from guaranteed rebate structures that lock in existing incentives toward ever higher list prices."

"The pharmaceutical industry can and should voluntarily begin disclosing the cost of their drugs in direct-to-consumer advertising," he continued. "Congress can and should act to preclude 'gag clauses' in private insurance as well as Medicare." Azar was referring to contract clauses that prohibit pharmacists from letting customers know when it would be cheaper to pay for a drug out-of-pocket than to go through their insurance.

"Congress can and should repeal the Obamacare giveaway to pharma by limiting the rebates in the Medicaid program for those actors who increase list prices faster than the rate of inflation, and Congress can and should act to get rid of the abuse of the 180-day generic exclusivity window currently being abused by generic and branded pharmaceutical companies to delay entry of competitive generic products," he added.

Azar's remarks came during a call that the agency convened to mark 100 days since President Trump released his plan to lower prescription drug costs for patients. "We have taken a significant amount of action in these 100 days, but this is just the beginning of a fundamental transformation," he said.

Azar cited actions the administration had taken in this area, including accelerating generic drug approvals, launching a work-group to consider ways to safely import certain sole-source branded drugs, launching a biosimilars action program, and publicizing companies who had used the FDA's Risk Evaluation and Mitigation Strategy (REMS) program to deny access to generic companies requesting samples of brand-name drugs for the purpose of developing generic versions.

He also lauded drugmakers for their actions so far. "Fifteen companies have made significant announcements on drug prices by either reducing prices ... or freezing prices at least," he said. "And a new analysis from the [HHS] Assistant Secretary for Planning and Evaluation finds that there have been 60% fewer brand-name price increases than the same period in 2017, and 54% more brand-name and generic price decreases."

However, some media outlets have reported that the drug companies' announcements were "largely symbolic" and would not greatly affect the companies' bottom lines. "Of the few companies that actually cut prices, for instance, most targeted old products that no longer produce much revenue -- such as Merck's 60% discount to a hepatitis C medicine that had no U.S. revenues in the first quarter," Politico noted in its story on the topic. "Others volunteered to halt price increases for 6 months -- in some cases, just weeks after announcing what is normally their last price hike for the year."

When asked by MedPage Today about this, Dan Best, the secretary's senior advisor for drug pricing reform, responded that "Our focus is getting the work done that we laid out in the blueprint; how manufacturers have decided to support or go in this direction -- it's something we're appreciative of. It does have an impact on what consumers would pay, but at the end of the day, the only way we're going to achieve our objective is to deliver on the blueprint as outlined on May 11th."

Congressional Democrats are also talking about the topic -- but in a different light. On Tuesday, Senate Democrats are holding an event featuring patients and their families who have been adversely affected by high prescription drug prices.

1969-12-31T19:00:00-0500

last updated

Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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