ASSIGNMENT: Profile the University of Maryland Medical System COI challenge.
DISCLOSURE. I am a member and Interim Chairman of the IRB* at Stevens Institute of Technology.
“There are many varieties of conflicts of interest, and they appear in different settings and across all disciplines. While conflicts of interest apply to a “wide range of behaviors and circumstances,” they all involve the use of a person’s authority for personal and/or financial gain. Conflicts of interest may involve individuals as well as institutions. Furthermore, individuals, in certain circumstances, may have conflicts occurring on both an individual and an institutional level, as may be seen among members of an Institutional Review Board (IRB).
Conflicts of interest are broadly divided into two categories: intangible, i.e., those involving academic activities and scholarship; and tangible, i.e., those involving financial relationships.” (A)
“In an article in the May 2014 issue of Compliance Today, Bill Sacks, Vice President and co-founder of HCCS, a HealthStream company, describes how new NIH regulations are forcing academic medical centers (AMCs) to examine and update their conflict-of-interest policies. He lists the 15 best practices for management of conflicts of interest that have been proposed by the Pew Charitable Trust and discusses how some of these recommendations are enjoying wide acceptance, as others are being met by serious objections. The Pew “Best Practice” recommendations are summarized below.
1. No gifts or meals should be accepted from industry sales representatives…
2. Faculty must disclose all conflicts of interest. All academic medical centers must have a process in place to manage conflict of interest (COI) disclosures.
3. Industry-funded speaking should not be allowed…
4. Industry-funding of continuing medical education (CME) should be severely limited or prohibited…
5. Faculty, students, and trainees should not attend industry-supported promotional or educational events…
6. Limit or prohibit pharmaceutical sales representative access in academic medical centers…
7. Limit medical device representative presence in academic medical centers to what is necessary…
8. Conflict-of-interest education should be required for all clinical staff and students
9. Conflict-of-interest policies should apply to everyone with a relationship to the academic medical center—paid, volunteering, affiliated, etc…
10. Industry-supported clinical fellowships should be available for scientific training only…
11. Ghostwriting and honorary authorship are strictly prohibited…
12. …Consulting arrangements must require written contracts with clear deliverables, to ensure that inappropriate payments are not involved…
13. Consulting relationships for marketing purposes are prohibited.
14. Pharmaceutical samples can be accepted and used only when they don’t become marketing tools.
15. Members of pharmacy and therapeutics committee cannot vote on formulary or treatment changes involving a company or product in which they have a financial interest… (B)
“Open Payments gives the public more information about the financial relationships between physicians and teaching hospitals and applicable manufacturers and GPOs. Specifically, the program:
Encourages transparency about these financial ties
Provides information on the nature and extent of the relationships
Helps to identify relationships that can both lead to the development of beneficial new technologies and wasteful healthcare spending
Helps to prevent inappropriate influence on research, education and clinical decision making. (C)
“Community Catalyst offers this Policy Guide to Academic Medical Centers and Medical Schools to assist leaders, faculty, staff and medical students in successfully adopting and improving policies to address conflicts of interest and interactions with the pharmaceutical and device industries. Policies such as these and their effective implementation are of critical importance to the integrity of medical education and patient care…
Toolkit on Transparency and Disclosure. Toolkit on Relations with Sales Representatives. Toolkit on Promotional Speaking. Toolkit on Continuing Medical Education. Toolkit on Ghostwriting and Name-Lending. Toolkit on Samples. Toolkit on Pharmaceutical and Therapeutics Committees. Toolkit on COI Policy Implementation. Conflict of Interest Curriculum Toolkit (D)
“Papers in medical journals go through rigorous peer review and meticulous data analysis.
Yet many of these articles are missing a key piece of information: the financial ties of the authors.
Nearly two-thirds of the 100 physicians who rake in the most money from 10 device manufacturers failed to disclose a conflict of interest in their academic writing in 2016, according to a study published Wednesday in JAMA Surgery.
The omission can have real-life impact for patients when their doctors rely on such research to make medical decisions, potentially without knowing the authors’ potential conflicts of interest…
They did this by sampling 10 large surgical and medical device manufacturers. This list includes Medtronic, Stryker Corp., Intuitive Surgical, Covidien, Edwards Lifesciences Corp., Ethicon, Olympus Corp., W.L. Gore & Associates, LifeCell Corp. and Baxter Healthcare.
The researchers also pinpointed the 10 physicians who received the highest compensation from each company. They then searched for articles published by these physicians between Jan. 1 and Dec. 31, 2016, and reviewed the full text of each article for COI disclosure.
According to their findings, those 10 companies paid more than $12 million in 2015 to the 100 doctors included in the study. The median payment to these physicians was $95,993.” (E)
“Memorial Sloan Kettering Cancer Center launched a conflict of interest task force in the wake of the resignation of its chief medical officer, Dr. José Baselga, who failed to disclose connections to medical industry…
The Manhattan-based cancer center said the task force will assess its internal policies and processes for reporting and managing outside activities and industry-supported clinical trials.
The task force was announced by President and Chief Executive Officer Dr. Craig Thompson. It will be chaired by Debra Berns, MSK’s Senior Vice President and Chief Risk Officer.
Among its objectives, the task force will: Review MSK’s policies, procedures, and training on conflicts of interest; Identify best practices in COI, including monetary and commitment limits; Assess new or improved processes to support timely and thorough disclosure; Identify medical societies and journals with whom to partner in improving public disclosure at meetings and in publications. (F)
“One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and the Lancet.
The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations; has had a stake in start-ups testing cancer therapies; and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.
According to an analysis by ProPublica and The New York Times, Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.
At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.” (G)
“Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles…
Thompson echoed comments he made to the hospital staff on Sunday, saying that the cancer center had “robust programs” in place to manage employees’ relationships to outside companies, but that “we will remain diligent.” He added, “There will be continued discussion and review of these matters in the coming weeks.” (H)
“An artificial intelligence start-up founded by three insiders at Memorial Sloan Kettering Cancer Center debuted with great fanfare in February, with $25 million in venture capital and the promise that it might one day transform how cancer is diagnosed.
The company, Paige.AI, is one in a burgeoning field of start-ups that are applying artificial intelligence to health care, yet it has an advantage over many competitors: The company has an exclusive deal to use the cancer center’s vast archive of 25 million patient tissue slides, along with decades of work by its world-renowned pathologists.
Memorial Sloan Kettering holds an equity stake in Paige.AI, as does a member of the cancer center’s executive board, the chairman of its pathology department and the head of one of its research laboratories. Three other board members are investors…
Hospital pathologists have strongly objected to the Paige.AI deal, saying it is unfair that the founders received equity stakes in a company that relies on the pathologists’ expertise and work amassed over 60 years. They also questioned the use of patients’ data — even if it is anonymous — without their knowledge in a profit-driven venture.” (I)
“…The AAMC is continuing to work with member institutions, other associations and societies, journals, and the continuing education community to develop tools and resources to help institutions and individuals manage the disclosure of conflicts of interest.
Institutions looking for immediate steps to take could:
Remind faculty of the importance of full disclosure, not only to your institution, but in other writing, speaking and teaching situations, as well as grant applications.
Use relevant current events as an opportunity to recommit to the institution’s obligation to facilitate transparency about the ways in which faculty and industry may be collaborating, and the processes that are in place to review and manage those relationships.
Encourage faculty to review the information posted about them publicly on the Open Payments website, and to ensure its accuracy as well as consistency with complete disclosures in all aspects of their professional responsibilities.” (J)
* “Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.” (K)
(A) https://ori.hhs.gov/education/products/columbia_wbt/rcr_conflicts/foundation/#1_1
(B) 15 Conflict-of-Interest Best Practices for Academic Medical Centers, https://www.healthstream.com/resources/blog/blog/2014/06/04/15-conflict-of-interest-best-practices-for-academic-medical-centers
(C) Open Payments Data in Context, https://www.cms.gov/OpenPayments/About/Open-Payments-Data-in-Context.html
(D) Conflict of Interest Policy Guide for Medical Schools and Academic Medical Centers, https://www.communitycatalyst.org/initiatives-and-issues/issues/prescription-drugs/conflict-of-interest-policy-guide
(E) Financial Ties That Bind: Studies Often Fall Short On Conflict-Of-Interest Disclosures, by Rachel Bluth, https://khn.org/news/financial-ties-that-bind-studies-often-fall-short-on-conflict-of-interest-disclosures/
(F) Memorial Sloan Kettering launches conflict of interest task force after CMO’s resignation, by David Robinson, https://www.lohud.com/story/news/health/2018/09/21/memorial-sloan-kettering-conflict-interest-task-force/1381042002/
(G) Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals, by Charles Ornstein and Katie Thomas, https://www.propublica.org/article/doctor-jose-baselga-cancer-researcher-corporate-financial-ties
(H) Top Official at Memorial Sloan Kettering Resigns After Failing to Disclose Industry Ties, by Charles Ornstein, and Katie Thomas, https://www.propublica.org/article/memorial-sloan-kettering-official-jose-baselga-resigns-after-failing-to-disclose-industry-ties
(I) Sloan Kettering’s Cozy Deal With Start-Up Ignites a New Uproar, by Charles Ornstein, and Katie Thomas, https://www.propublica.org/article/sloan-kettering-cozy-deal-with-start-up-paige-ai-ignites-new-uproar
(J) Conflicts of Interest and Transparency Initiatives, https://www.aamc.org/initiatives/research/coi/
(K) Institutional Review Boards Frequently Asked Questions – Information Sheet, https://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm
(L) Facing Crisis, Sloan Kettering Tells Exec to Hand Over Profits From Biotech, by Katie Thomas and Charles Ornstein, https://www.propublica.org/article/facing-crisis-sloan-kettering-tells-exec-to-hand-over-profits-from-biotech(M)
Addendum
“A vice president of Memorial Sloan Kettering Cancer Center has to turn over to the hospital nearly $1.4 million of a windfall stake in a biotech company, in light of a series of for-profit deals and industry conflicts at the cancer center that has forced it to re-examine its corporate relationships…
The move to hand over his stake is one of several steps now underway as the cancer center tries to contain a crisis that has already led to the resignation of its chief medical officer and a review of its conflict-of-interest policies. Several board members and some executives of the nonprofit institution have maintained close ties to the health and drug industries at a time when stunning cancer breakthroughs are generating excitement among investors and spawning a flurry of biotech startups.
At other cancer centers and research institutions, employees are barred from accepting personal compensation when they represent their institution on corporate boards. But Memorial Sloan Kettering had no such prohibition until now.” (L)
When “googling” for hospital information we often wind up at hospital web sites.
Hospital web sites are marketing based so how does one find and aggregate key elements and then do comparative analysis?
You can use these web sites for this exercise, all hospitals with which I have been involved
City Hospital Center at Elmhurst (I was the Administrator of Mount Sinai Services, 1975-1979)
https://www.nychealthandhospitals.org/elmhurst/
Mount Sinai Hospital (I held various positions at the medical school and medical center from 1979-1989, leaving as an SVP)
https://www.mountsinai.org/locations/mount-sinai
LibertyHealth/ Jersey City Medical Center (I was President & CEO from 1989-2006. Now, Jersey City Medical Center/ RWJ Barnabas Health)
https://www.rwjbh.org/jersey-city-medical-center/
Meadowlands Hospital Medical Center (was part of LibertyHealth with Jersey City Medical Center; has changed ownership several times in the last ten years, now Hudson Regional Hospital)
https://www.hudsonregionalhospital.com/
CarePoint Health/ Hoboken (I was on the Board of the Hoboken Municipal Hospital Authority for three years; now owned by CarePoint Health)
or better yet, compare hospitals in your medical service area!
Ok, let’s get started:
Find ABOUT US. This is the picture painting how the hospital wants to be envisioned.
Find the MISSION STATEMENT, a formal summary of the aims and values of the hospital, as approved by the Board of Trustees and required for accreditation.
Compare ABOUT US and the MISSION STATEMENT. Are they clear and consistent?
Find ACCREDITATION. This gets trickier. A long list of certifications is not in of itself important. What is important is are they evidenced-based, completed by an arms-length review, and for a fixed period of time then must be renewed. You can google the agency and find the methodology used.
Find QUALITY. Again quality recognition awards should be evidenced-based, completed by an arms-length review, and for a fixed period of time then must be renewed. You can google the agency and find the methodology used.
Find AFFILIATIONS. A medical school affiliation is an excellent benchmark, however is it robust or ceremonial?
Go to LEADERSHIP/ BOARD OF TRUSTEES. Are Board member recognized community leaders?
And then go to
HOSPITAL COMPARE https://www.medicare.gov/hospitalcompare/search.html
at this MEDICARE site you can compare hospital performance metrics
HOSPITAL COST COMPARE/ CMS
http://www.hospitalcostcompare.com/
what over 3000 U.S. Hospitals billed Medicare for the top 100 Diagnosis Related Groups (DRGs) along with what Medicare actually reimbursed
OPEN PAYMENTS/ CMS.gov https://openpaymentsdata.cms.gov/
search payments made by drug and medical device companies to physicians and teaching hospitals.
THE LEAPFROG GROUP http://www.leapfroggroup.org/compare-hospitals
an independent organization where you can compare hospital quality metrics
US NEWS. BEST HOSPITALS REGIONAL RANKINGS
https://health.usnews.com/best-hospitals/area
ranks hospitals regionally in both states and major metro areas
THE JOINT COMMISSION
https://www.jointcommission.org/
An independent, not-for-profit organization, The Joint Commission accredits and certifies nearly 21,000 health care organizations and programs in the United States.
https://www.qualitycheck.org/
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY http://archive.ahrq.gov/consumer/qnt/qnthosp.htm
Choosing a Hospital Worksheet
Then take a look at:
NATIONAL QUALITY FORUM
http://www.qualityforum.org/About_NQF/
NQF measures and standards serve as a critically important foundation for initiatives to enhance healthcare value, make patient care safer, and achieve better outcomes.
AVOID for-profit “hospital quality” web sites like Healthgrades.
“Partnering with Healthgrades doesn’t just give you access to our talented marketing services group — it’s more accurate to say it becomes an extension of your own marketing department. Our team is dedicated to your success and available when you need us.”
https://hs.healthgrades.com/solutions/marketing-services
“At his surgery center near San Diego, Rodney Davis wore scrubs, was referred to as “Dr. Rod” and carried the title of director of surgery. But he was a physician assistant, not a doctor, who anesthetized patients and performed liposuction with little input from his supervising doctor, court records show.
So it was perhaps no surprise, in 2016, when an administrative judge stripped Davis of his license, concluding it was the only way to “protect the public.” State officials also accused two former medical directors of Pacific Liposculpture of enabling Davis to act as a doctor.
One powerful authority in California took a different view. The state-approved private accreditation agency that oversees the center left its approval in place. So the center is still operating and Davis remains an owner and administrator, state records show.
California is the only state with more than 1,000 surgery centers that has given private accreditors a lead role in oversight. Those accreditors are typically paid by the same centers they evaluate.
That approach to oversight has created a troubling legacy of laxity, an investigation by Kaiser Health News shows. In case after case, as federal or state authorities waved red flags, state-approved accreditation agencies affixed gold seals of approval, according to a KHN review of hundreds of pages of doctors’ disciplinary records, court files and accreditor reports — which are public only for California surgery centers.” (A)
Then…
The next challenge is reconciling accepted metrics with data connected on the internet!
A recent report..
“Crowd-sourced ratings of the “best overall” hospitals produced scores similar to Hospital Compare’s ratings, but crowd-sourced ratings were less reliable as indicators of clinical quality and patient safety, according to recent research.
The study in Health Services Research examined hospital ratings on Facebook, Google Reviews, and Yelp. The findings showed crowd — sourced ratings reflected patient experience rather than other factors…
The research examined data from nearly 3,000 acute care hospitals. Perez’s group found that:
• For best-ranked hospitals on the crowd-sourcing sites, 50% to 60% were ranked best in Hospital Compare’s overall rating.
• For best-ranked hospitals on the crowd-sourcing sites, 20% ranked worst in Hospital Compares overall rating.
• For clinical quality and patient safety, hospitals ranked best on crowd-sourced sites were only ranked best on Hospital Compare about 30% of the time.
Perez said Hospital Compare, which combines as many as 57 metrics for patient experience and clinical quality, was used to gauge the accuracy of the crowd-sourcing sites for several reasons.
“The clinical quality and patient safety measures are based on Medicare claims data, which means there is a lot of information about patients, and they can do risk adjustment,” she said of Hospital Compare.
Risk adjustment is crucial when comparing hospitals, she added. “Rather than being concerned that some hospitals are treating a sicker pool of patients, and have worse outcomes as a result, the Hospital Compare data can be adjusted for the health of the patient mix.”
The crowd-sourcing sites are more prone to bias, she said. “A concern when you look at social media is that people only write reviews when they have really good or really bad patient outcomes,” she pointed out.” (B)
Postscript.
“Medscape asked over 11,000 physicians to rank their preferences for care and treatment for themselves or family, assuming no barriers, such as transportation or cost.” (C)
(A) Despite Red Flags At Surgery Centers, Overseers Award Gold Seals, by Christina Jewett, https://khn.org/news/despite-red-flags-at-surgery-centers-overseers-award-gold-seals/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202018-09-20%20Healthcare%20Dive%20%5Bissue:17208%5D&utm_term=Healthcare%20Dive
(B) Crowd-Sourced Ratings Rely Heavily on Patient Experience, by Christopher Cheney, https://www.medpagetoday.com/hospitalbasedmedicine/generalhospitalpractice/75111?xid=nl_mpt_DHE_2018-09-19&eun=g1223211d0r&pos=11111&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-09-19&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days
(C) Medscape Physicians’ Choice: Top Hospitals for Key Conditions and Procedures (Non-cancer), https://www.medscape.com/slideshow/top-hospitals-key-conditions-6010216?faf=1#1
Previously posted was an op-ed describing Jersey City Medical Center’s “Rapid Response” role after the attack on the World Trade Center towers.
Military helicopters and jets were overhead, as President Bush was getting ready to leave. The plumes of smoke from the World Trade Center were still billowing skyward.
https://network.aupha.org/communities/community-home/digestviewer/viewthread?MessageKey=d375f16c-d2ff-4d54-b93f-d33c3c6330b3&CommunityKey=7457c476-880a-47b2-ad0b-8677bba9e9e4&tab=digestviewer#bmd375f16c-d2ff-4d54-b93f-d33c3c6330b3
Since Jersey City Medical Center was the New Jersey anchor in the response, I prepared a confidential Lessons Learned memorandum in preparation for a Debriefing Meeting called by the Democratic Party candidate for Governor.
As a courtesy I provided a copy of the memorandum to Bret Schundler, the former Mayor of Jersey City who was out-of-the country on September 11th and could not get back for almost a week. He was the Republican Party candidate for Governor. I forget that “No good deed goes unpunished” and Schundler widely circulated the document as a campaign issue.
“Rookie” mistake! Read the article below. What would you have done differently?
New York Times. September 22, 2001
Schundler Assails New Jersey’s Response to Terrorist Attack
By DAVID M. HALBFINGER
Making the World Trade Center disaster the focus of his campaign for governor, Bret D. Schundler is criticizing New Jersey’s response to the attack and has released his own plan to improve the state’s defenses against terrorism and its preparedness for future emergencies.
Mr. Schundler, the Republican candidate, has said that both the State Police and the National Guard reacted slowly and mismanaged their resources after the Sept. 11 attack, and that flaws in New Jersey’s emergency-management system made it difficult to coordinate the efforts of hospitals, ambulance crews and other volunteers.
Mr. Schundler, the former mayor of Jersey City, is now calling for bolstering New Jersey’s defenses, including restoring to the nation’s air-defense system an Air National Guard fighter wing that is stationed in Atlantic City and which, until two years ago, had two F-16’s ready to scramble 24 hours a day. He said New Jersey should conduct a thorough inventory of sensitive installations, like power plants, reservoirs and chemical factories, and immediately enhance security at Newark Airport and the the Hudson and Delaware River crossings.
He is also proposing an array of measures to improve the state’s response to emergencies, like maintaining rosters of doctors, nurses, engineers and others who might be needed in the case of another terrorist attack.
Mr. Schundler’s aides described his proposals as an attempt to provide leadership where it was needed and denied that he was trying to jump-start his campaign, which has stalled along with most of the political machinery in New Jersey.
But in critiquing the state agencies, hospitals and other institutions that responded to the attack — while the smoke is still rising from ground zero and many voters are still awaiting the remains of their loved ones — Mr. Schundler is running a huge risk: that he could be seen as trying to make hay out of a national tragedy.
”This is not a political exercise,” said Richard McGrath, a spokesman for James E. McGreevey, the Democratic candidate. ”Jim McGreevey’s been working in a quiet way to assimilate as much information as possible to address emergency needs and prevent future catastrophes,” Mr. McGrath said. ”This terrorist incident has had a profound effect on all Americans, and we don’t intend to parcel it out with any political agendas.”
In a telephone interview he initiated on Thursday, Mr. Schundler described a number of ways in which the state’s response to the attack had apparently broken down. For instance, he said he had been told by a police official in Jersey City that the State Police troopers who set up an operations center in Liberty State Park ”didn’t do much of anything — they just sat there.”
Mr. Schundler added that the troopers’ ”inaction” had forced the city’s police department to coordinate the supply effort for emergency workers, and said that troopers did not even arrive in Jersey City until 4:30 p.m. on the day of the attack.
Officials of the State Police and other agencies today briefed Mr. Schundler and Mr. McGreevey about their efforts. But on Thursday, Col. Carson Dunbar, the superintendent of the force, said there had been numerous tussles over turf in the hours after the attack, which were compounded by the loss of a radio-transmission tower at the World Trade Center, and which could have led to crossed signals about troopers’ assignments. But Colonel Dunbar said that state troopers were on the scene in Jersey City almost immediately after the attack. For instance, he said, one marine unit was among the first to ferry the injured to safety in New Jersey.
On Thursday, Mr. Schundler also released a five-page memorandum about breakdowns in the state’s response system that was prepared by Jonathan M. Metsch, president and chief executive of Jersey City Medical Center, which treated 175 people hurt in the attack.
The memo noted that police from outside Jersey City had prevented staff members from getting to the hospital; that National Guard troops who drove ambulances to the hospital ”had no leadership and provided no help”; that the blood donor system ”did not work”; and that it ”took too long” to prepare a list of the injured being treated at New Jersey hospitals, meaning each hospital was inundated with thousands of calls.
Dr. Metsch, reached today, said he had written the memo for state health officials, that it amounted only to his own impressions, and that he had done so merely to ensure that lessons would be learned, not to assess blame. He said he provided a copy to Mr. McGreevey on Wednesday after a private meeting of hospital executives that Mr. McGreevey had called to inquire about the response to the twin towers attack and ways to improve New Jersey’s readiness.
Dr. Metsch said he then provided a copy to Mr. Schundler, whom he called a friend, as a courtesy. But he said he had not expected the memo to be released to the public. ”These were off-the-record observations,” he said, adding that over all, New Jersey performed admirably.
But Bill Pascoe, Mr. Schundler’s campaign manager, said Dr. Metsch had not asked Mr. Schundler to keep the memo confidential. And he said Mr. Schundler’s use of it transcended politics.
”If the U.S. responds anytime in the next few days or weeks, we may be facing an immediate counterattack from the terrorists,” Mr. Pascoe said.
”We don’t have the luxury of time to let the dust settle. We have to use this event and our response to it right now as a learning exercise. What have we learned about what we did right and did wrong? What can we do better? That’s the point, and that’s the job of a leader.”
*written by Jonathan M. Metsch on September 14, 2001; published in the Jersey Journal on September 18, 2001
Suddenly a huge white military hospital ship with four Red Crosses steamed by and docked right across river. I thought how this hospital ship brought the war even closer to home but mostly about how the hospitals in Hudson County had responded and performed so magnificently.
Liberty HealthCare System is comprised of Jersey City Medical Center, Greenville Hospital, and Meadowlands Hospital Medical Center. The Medical Center, the County’s Trauma Center, treated 175 patients. Greenville treated 11 patients and processed over 500 volunteers who wanted to give blood; Greenville had originally been asked by the Red Cross to be a blood center but this was changed early on so donor information was passed (every volunteer was “typed and matched”) to the blood collection centers. Meadowlands treated 7 patients and was preparing to be a command center given its heliport; late Tuesday night Governor DiFrancesco used the heliport to depart from his visit to the triage center at Liberty State Park.
Every hospital in the County provided emergency services to victims. According to the Jersey Journal: Palisades Medical Center treated 12 patients; St. Francis Hospital treated 67 patients; Christ Hospital treated 54 patients; St. Mary Hospital treated 74 patients. Bayonne Hospital treated 58 patients.
At the Medical Center staff watched from windows the attack on the World Trade Center, then immediately went on Disaster Alert. Over 150 physicians covering all medical and surgical specialties were in the building as they are every day, and over 1000 other staff joined predetermined teams – trauma and surgery in the emergency room, and “walking wounded” in the auditorium. The library was organized for aftercare and rooms were set up for family members arriving from all over the metropolitan area. The injured started arriving around 10AM and suddenly, and sadly, everything stopped about 6PM. We hope and waited for more patients, and still wait “on alert”, our hope fading.
Since the New York City Command Center was in the World Trade Center complex and destroyed, good information was not available. We were told to expect somewhere between 2000 and 5000 injured.
Many others contributed to our success in handling the medical response to this act of war:
– Over 200 ambulances simply appeared from all over the state to assist. They were restocked from Medical Center inventory and dispatched by Medical Center EMS.
– New Jersey Commissioner of Health and Senior Services George DiFerdinando was in contact with us immediately and made sure we were re-supplied, and developed a plan with whereby trauma centers outside of Hudson County were on high alert so patients could be transported there to prevent Hudson County hospitals from being overwhelmed.
– Every hospital in the New Jersey was on disaster alert with elective admissions and surgery cancelled, and disaster teams ready until late Tuesday evening.
– Providers of food, IV solutions, medications, surgical supplies, and much more sent in truckloads of supplies without being asked.
– Volunteers poured in to help us in any way possible. For example with their help a “Hot Line” was set up at the Medical Center with up-to-date information on all disaster victims seen at New Jersey hospitals. This “Hot Line” was soon designated as “official” until the New York City Command Post was reestablished.
– Hudson Cradle opened its doors, wanting to help, wanting to serve.
– Mayor Cunningham and Jersey City police and fire officials coordinated all local efforts while supporting the recovery in New York City and securing the waterfront where victims were arriving by ferry in great numbers to several sites including Exchange Place and Liberty State Park. I know public officials in Hoboken, Secaucus, Bayonne and Weehauken did the same.
– And untold numbers were praying for the victims and those providing care – we could feel those prayers.
How can you help? Volunteer to give blood; blood will be needed for weeks and months to come. If you can, make a cash donation to help the families of those killed in this tragedy. Certainly go to community vigils and prayer services. Befriend someone who does not look like you and let them know that all Americans share this pain together and that the beauty of America is that we all came from somewhere else, and now live and work harmoniously side-by-side.
On a practical level we and other local hospitals can use your help. If you are a mental health worker and want to help with World Trade Center disaster Crises Counseling in hospitals, schools, and offices please call us. If you are a nurse who works outside the County or doing something else right now – particularly emergency room, critical care and operating room nurses, though all nurses are welcome – and want to be on our roster of volunteers for future emergencies please us. And if you just want to join the cadre of volunteers at our hospitals please call us. Please call 201 915-2048.
Finally I want to thank all the staff at Liberty, who once again, provided services so well. They acted heroically while worried about missing family and friends, and their children at home who had to cope with this tragedy without them nearby. I am honored to work with you
“A doctor in the Democratic Republic of Congo (DRC) has been hospitalised with the deadly Ebola virus after coming into contact with nearly 100 people…
The World Health Organization (WHO) said on Friday investigating the infection and its possible spread to 97 people in contact with the physician would be difficult because the area was entirely surrounded by rebels.”
“It is the first time we have a confirmed case and contacts in an area of high insecurity,” said Dr Peter Salama, WHO’s deputy director-general for emergency preparedness and response.
“It is really the problem we were anticipating and at same time dreading,” he told a news briefing.” (A)
““Really, in two weeks, we’ve gone from 24 cases to 105 cases,” … mainly because many health workers at a hospital in the town of Mangina, where the outbreak began, became infected when they treated early patients without recognizing that they had Ebola and therefore did not take adequate precautions….
So far, Redfield said, it is not necessary to test travelers at U.S. ports of entry, in part because there are no direct flights to the United States from the affected region and screening of outgoing travelers is being conducted. Four years ago, debate raged about whether to cut off all travel from West Africa to the United States. President Trump, then a private citizen, was an outspoken advocate of that position, tweeting that the United States should not allow two infected American missionaries back into the country for treatment.” (B)
“Military escorts are helping health workers quell an Ebola outbreak in eastern Democratic of Congo that’s killed 63 people in three weeks…
World Health Organization and Health Ministry workers are using escorts from the Congolese army and the United Nations peacekeeping force in areas of insecurity, said Michael Yao, a WHO spokesman. Other key partners, such as Doctors Without Borders and the International Federation of Red Cross & Red Crescent Societies, eschew the assistance to maintain their neutrality.” (C)
“Uganda has opened two Ebola treatment units in the border districts with the Democratic Republic of Congo, a World Health Organisation official said.
Yonas Woldemariam, WHO Representative in Uganda, told Xinhua that the two treatment units have been established in the western border districts of Kasese and Bundibugyo to respond to any deadly Ebola hemorrhagic fever alert case or outbreak.
He said the units are fully equipped and ready to manage any Ebola case in the east African country.
“Ebola Treatment Units are where patients can get the best care possible – with access to rehydration methods and protection from infecting their family and community,” said Woldemariam.
Although there is no confirmed Ebola case in Uganda, the country remains on high alert following an outbreak of the hemorrhagic fever in neighbouring DRC. “ (D)
“Congo has approved the use of four more experimental treatments in the Ebola virus outbreak in its northeast, as health officials try to contain the spread amid the threat from armed groups in the region.
The treatments ZMapp, Remdesivir, Favipiravir and Regn3450 – 3471 – 3479 can now can be used on those suffering from Ebola, the health ministry said Wednesday. On Tuesday, health officials administered Remdesivir, which is produced by Gilead Sciences, to a patient in Beni, the ministry said.
Health officials began using the mAb114 treatment on Aug. 11 on 10 patients and the ministry said they were doing well.” (E)
“Congo’s health ministry says two of the first 10 people to receive an experimental treatment for the Ebola virus in the latest outbreak have recovered, and monitoring could show what role the treatment played.
The head of the World Health Organization on Saturday congratulated Congo’s government for making several experimental treatments available in this Ebola outbreak, calling it “a global first, and a ray of hope for people with the disease.”
The two people received the mAb114 treatment isolated from a survivor of an Ebola outbreak in 1995. It was the first of five experimental treatments Congo approved for use in the outbreak that was declared on Aug. 1. The others are ZMapp, Remdesivir, Favipiravir and Regn3450 – 3471 – 3479.” (F)
Interim Guidance for Preparing Ebola Treatment Centers
Who this is for: State and local health departments and acute care hospitals designated as Ebola treatment centers.
What this is for: Guidance to assist state and local health departments and acute care hospitals as they develop preparedness plans to serve as Ebola treatment centers.
Key Points
1. Ebola treatment centers are prepared to provide comprehensive care to people diagnosed with Ebola virus disease (EVD) for the duration of a patient’s illness.
2. Designation as an Ebola treatment center will be a decision made between state and local health authorities and the hospital administration, informed by the results of a CDC site visit conducted by an interdisciplinary team of subject matter experts.
3. Decisions to receive a patient with EVD should be informed by discussions with public health authorities and referring physicians, depending on the status of the patient. (G)
“The UN Children’s Fund said more than 82,500 children are being prepared for the new school year in Ebola-affected areas of the Eastern Democratic Republic of the Congo .
UNICEF said it was scaling up education, health and water, sanitation and hygiene programmes to assist the schools to provide a protective learning environment for children and their teachers.” (H)
“Days after the Democratic Republic of the Congo declared an end to a deadly Ebola outbreak in the western province of Équateur, a new one emerged in North Kivu province. With the number of cases and death toll rising rapidly, the country’s ministry of health, the World Health Organization, and partners are working to launch a rapid and effective response that includes the use of an experimental vaccine. But their decision not to vaccinate women who are pregnant or lactating unfairly deprives them of the protection they deserve against this deadly disease….
Some contacts, though, won’t get the vaccine. Pregnant women and those who are lactating are being excluded from this life-saving intervention. From a public health perspective and an ethical perspective, the decision to exclude pregnant and lactating women is utterly indefensible.
There’s no question that evidence about the safety of the Ebola vaccine in pregnancy is limited. But what we don’t know is dwarfed by what we do know. We know that in previous outbreaks, up to 90 percent of pregnant women infected with Ebola died from it. We know that nearly 100 percent of the pregnancies of Ebola-infected women end in miscarriage or neonatal death. And we also know that pregnant and lactating women are more likely than many others in the population to be caring for sick relatives, and thus are among those most likely to be infected. Indeed, the most recent WHO situation report on Ebola in the DRC shows that a large proportion of the cases are among women of childbearing potential.” (I)
“The World Health Organization (WHO) reports the next seven to 10 days are critical in controlling the spread of the Ebola virus in eastern Democratic Republic of Congo. Its latest update reported 111 cases of Ebola, with 83 confirmed and 28 probable, including 75 deaths.
The WHO reports it is continuing to rapidly scale-up its response to the Ebola outbreak in North Kivu and Ituri provinces, including in Oicha, a town difficult to reach because of security concerns.
More than 100 armed groups are operating in these areas, putting some places, known as Red Zones, off limits because of the dangers. But, WHO spokesman Christian Lindmeier told VOA health workers have had access to all places they need to go with the help of MONUSCO, U.N. peacekeepers acting as escorts…
Lindmeier said the next week is critical in efforts to prevent Ebola from spreading to areas that cannot be reached.
“The quicker we can respond and in which we can get to people, to talk to them about how to protect themselves, how to prevent infection, how to deal with infected family members and loved ones, the better it is for any future control,” he said. “So, the earlier we get to any place where this outbreak could possibly reach, the better.”” (J)
(A) DRC: Doctor stricken with Ebola in rebel stronghold, https://www.aljazeera.com/news/2018/08/drc-doctor-stricken-ebola-rebel-stronghold-180824095226217.html
(B) Ebola outbreak now at 105 cases, and bordering countries are on alert, by Lena H. Sun and Lenny Bernstein, https://www.washingtonpost.com/national/health-science/ebola-outbreak-now-at-105-cases-and-bordering-countries-are-on-alert/2018/08/24/3b7a58a2-a7c2-11e8-a656-943eefab5daf_story.html?noredirect=on&utm_term=.53c97b919f02
(C) Military Escorts Back Ebola Response in Restive Congo Region, by William Clowes and Ignatius Ssuuna, https://www.bloomberg.com/news/articles/2018-08-23/military-escorts-back-ebola-response-in-restive-congo-region
(D) Uganda opens Ebola treatment units at border with DRC, https://punchng.com/uganda-opens-ebola-treatment-units-at-border-with-drc/
(E) Congo approves 4 experimental Ebola treatments in outbreak, by CARLEY PETESCH, https://abcnews.go.com/Health/wireStory/congo-approves-experimental-ebola-treatments-outbreak-57328608
(F) Two of first 10 people recover from Ebola outbreak in Congo after receiving experimental treatment, officials say, by Saleh Mwanamilongo, https://nationalpost.com/news/congo-2-who-received-experimental-ebola-treatment-recover
(G) Interim Guidance for Preparing Ebola Treatment Centers, https://www.cdc.gov/vhf/ebola/healthcare-us/preparing/treatment-centers.html
(H) UNICEF prepares DRC school children for Ebola response, https://punchng.com/unicef-prepares-drc-school-children-for-ebola-response/amp/
(I) Pregnant and lactating women should be vaccinated in an Ebola outbreak , by Ruth Faden, Ruth Karron, and Carleigh Krubiner, https://www.statnews.com/2018/08/27/ebola-vaccine-pregnant-lactating-women/?utm_source=STAT+Newsletters&utm_campaign=9fa414a249-MR_COPY_12&utm_medium=email&utm_term=0_8cab1d7961-9fa414a249-149527969
(J) WHO: Rapid Response Needed to Stem Ebola Outbreak in DR Congo, https://www.voanews.com/a/who-rapid-response-needed-to-stem-ebola-outbreak-in-dr-congo/4547478.html
“We are on an epidemiological precipice. We have a critical, time-limited window of opportunity to prevent the #DRC #Ebola outbreak from taking hold in areas that are much more difficult to access because of insecurity. There is not a minute to lose.” Peter Salama, deputy director-general for emergency preparedness and response
Public health officials in the Democratic Republic of the Congo are scrambling to contain the Ebola outbreak, as neighboring countries of Burundi, Rwanda, South Sudan and Uganda bolster their readiness in case the hemorrhagic virus spreads past their border…
Concerns about conflict zones: One of the big concerns is that one of the affected areas is in a conflict region, which is dangerous for health care workers and is near the border of Uganda.
Peter Salama, a top World Health Organization official, told STAT News:
“That’s really the worst-case scenario: That we can’t get in quickly enough to an alert [of possible cases] or we just have a blind spot because of security. And then an outbreak really begins to take hold in those blind spots and becomes a multicountry regional outbreak.”..
Meanwhile, the DRC is continuing its vaccination, treatment and education program. The spokesperson tells Axios:
(A)
“ “The environment is really conducive for Ebola to transmit freely. This is a very dangerous outbreak.
“What makes the outbreak in eastern DRC or northern Kivu more dangerous is there is a security challenge – there is active conflict in that area.”
Because of the ongoing fighting, some areas have been designated “red zones”.
As a result health officials and aid agencies find it difficult to access these areas, making it hard to find, isolate and treat potential cases.
Such areas were potential “hiding places” for the disease, which WHO figures suggest has a mortality rate of about 50 percent.” “ (B)
“The possibility that the virus could spread unchecked in one of these areas raises prospects of an outbreak that could make this year’s earlier brush with Ebola seem like a training exercise.
“That’s really the worst-case scenario: That we can’t get in quickly enough to an alert [of possible cases] or we just have a blind spot because of security. And then an outbreak really begins to take hold in those blind spots and becomes a multicountry regional outbreak,’’ Dr. Peter Salama, the World Health Organization’s deputy director-general of emergency preparedness and response, told STAT.
“That’s what keeps me up at night.”
The outbreak was declared in North Kivu on Aug. 1, a week after the previous epidemic was deemed contained. Genetic analysis of viruses from the two show that while they are caused by the same species of ebolaviruses, Ebola Zaire, they are not linked..
North Kivu is in northeastern Congo, near the border with Uganda and Rwanda. It’s the country’s most populous province, with 8 million people. It is also its most dangerous.
Under a scoring system used by the U.N. to determine the level of risk for its personnel in conflict zones, North Kivu is at level 4. Level 5 means the U.N. must evacuate; it is simply too perilous to be present.” (C)
“”That environment is really conducive for Ebola … to transmit freely.
“We call on the warring parties for cessation of hostilities, because the virus is dangerous to all. It doesn’t choose between this group or that group,” he said.” (D)
“The U.N. refugee agency is working closely with DRC authorities and other agencies on actions to contain Ebola on the national and regional level. But, its main focus is to monitor possible Ebola infections among refugees fleeing across the border, mainly to Uganda, from conflict ridden North Kivu and Ituri.
UNHCR spokesman, William Spindler says the number of newly arriving refugees into Uganda from these two Ebola affected provinces increased during July from 170 a day to 250 a day. He says the majority currently is crossing at the Kisoro border point.
“So UNHCR is working with WHO, UNICEF and other partners and with the Ministry of Health of Uganda to intensify screening for Ebola at all border entry points. And, additional health workers have been deployed in the border districts to improve response capacity,” he said.
Spindler notes the World Health Organization is not recommending any restriction on the movement of people. Therefore, he says UNHCR is urging countries neighboring DRC to allow refugees in need of protection to enter their territory and to include them into preparedness and response plans and activities.
The UNHCR says refugees are at the same risk of contracting and transmitting the Ebola virus disease as local farmers, merchants, business people and others moving through the area. Therefore, it urges governments and local communities not to adopt measures that single out refugees. Those measures may not be scientifically sound and will only serve to stigmatize and restrict refugees’ freedom of movement.” (E)
“The World Health Organization (WHO) said on Friday that at least 1,500 people had been potentially exposed to the deadly Ebola virus in the Democratic Republic of Congo’s North Kivu region, where insecurity prevents aid workers from reaching some areas.
But it expected more people to become infected and could not be sure that it had identified all chains by which the virus is spreading in the eastern part of the country beset by militia violence….
“We don’t know if we are having all transmission chains identified. We expect to see more cases as a result of earlier infections and these infections developing into illness,” WHO spokesman Tarik Jasarevic told a Geneva news briefing.
“We still don’t have a full epidemiological picture… The worst case scenario is that we have these security blindspots where the epidemic could take hold that we don’t know about,” he said.” (F)
“The ongoing deadly Ebola outbreak in the eastern part of the Democratic Republic of the Congo has particularly affected children, the United Nations Children’s Fund has said.
The outbreak in North Kivu Province was declared on August 1, and the UN children’s agency reported that more than 50 youngsters have lost their parents to Ebola.
UNICEF added that so far two children have died, while six others – who either are infected by the disease or suspected to be – are receiving treatment at two centres in the region.
Dr Gianfranco Rotigliano, UNICEF Representative in the DRC, said: “The children affected by the ongoing epidemic need special attention and care.
“Women are the primary caregivers for children, so if they are infected with the disease, there is a greater risk that children and families become vulnerable.”…
UNICEF and partners have trained nearly 90 psychosocial workers to assist and comfort children in Ebola treatment centres.
These professionals also support children who have been discharged, but who may be at risk of stigmatisation within their communities, and organised awareness-raising activities to facilitate their return. “ (G)
“The deadly Ebola outbreak in eastern DR Congo has now claimed 49 lives since the start of the month, the government has said, and the World Health Organization expects more cases.
The gradually increasing death toll, with a further 2,000 people feared to have come into contact with the virus, adds to the woes of a country already facing violence, displacement and political uncertainty.
First reported on August 1 in the North Kivu province, the current outbreak has killed 49 of the 90 cases reported, according to the latest health ministry bulletin on Saturday.” (H)
At least 10 health-care workers have been infected with the deadly Ebola virus as they battle an outbreak in an eastern province of Congo, officials said over the weekend, as concerns mount that the number of cases is growing faster than public health officials can respond…
The Health Ministry and the World Health Organization (WHO) expect more cases to emerge in the coming weeks. The Ebola virus disease carries an incubation period of up to 21 days, meaning it can take as long as three weeks for an infected person to show symptoms.
Tarik Jasarevic, a spokesman for the WHO in Geneva, told The Hill that health officials had identified more than 1,500 people who had come into contact with a possible or confirmed Ebola patient…
“Health-care workers are at the front line and extremely vulnerable to infection. They work in poor conditions, often without personal protective equipment, and thus [are] often exposed before an outbreak is detected,” Rimoin said. “The reason this is so important is because health-care workers can easily propagate disease given that they have contact with many sick people and their own families.”” (I)
(A) WHO official: Congo’s Ebola on “precipice” to spread further, by Eileen Drage O’Reilly, https://www.axios.com/who-warns-congo-ebola-outbreak-on-precipice-995ceba1-5d2a-4823-a796-f36cf57faa85.html
(B) Ebola latest: Dangerous outbreak can ‘spread rapidly’, warns WHO boss. by CIARAN MCGRATH, https://www.express.co.uk/news/world/1004172/Ebola-latest-news-dangerous-ebola-outbreak-rapidly-war-zone-who-vaccination
(C) Ebola outbreak shaping up as most dangerous test of world’s ability to respond since global crisis, by Helen Branswell, https://www.statnews.com/2018/08/16/ebola-outbreak-challenges/
(D) WHO says DRC conflict hindering push to stem Ebola outbreak https://www.aljazeera.com/news/2018/08/drc-conflict-hindering-push-stem-ebola-outbreak-180814172937317.html
(E) WHO says DRC conflict hindering push to stem Ebola outbreak, https://www.aljazeera.com/news/2018/08/drc-conflict-hindering-push-stem-ebola-outbreak-180814172937317.html
(F) WHO expects more Ebola cases in Congo, can’t reach no-go areas, by Stephanie Nebehay, https://www.reuters.com/article/us-health-ebola-who/who-expects-more-ebola-cases-in-congo-cant-reach-no-go-areas-idUSKBN1L20VB
(G) Child victims of Congo’s Ebola outbreak need ‘special care’ – UNICEF, https://punchng.com/child-victims-of-congos-ebola-outbreak-need-special-care-unicef/
(H) Ebola deaths in DR Congo rises to 49 with 2,000 feared ‘contacts’, https://punchng.com/ebola-deaths-in-dr-congo-rises-to-49-with-2000-feared-contacts/
(I) Ebola crisis worsens in Congo, health workers infected, by REID WILSON, http://thehill.com/policy/international/402553-ebola-crisis-worsens-in-congo-health-workers-infected
(J)
“When historians trace back the roots of today’s opioid epidemic, they often find themselves returning to the wave of addiction that swept the U.S. in the late 19th century. That was when physicians first got their hands on morphine: a truly effective treatment for pain, delivered first by tablet and then by the newly invented hypodermic syringe. With no criminal regulations on morphine, opium or heroin, many of these drugs became the “secret ingredient” in readily available, dubiously effective medicines.
In the 19th century, after all, there was no Food and Drug Administration (FDA) to regulate the advertising claims of health products. In such a climate, a popular so-called “patent medicine” market flourished. Manufacturers of these nostrums often made misleading claims and kept their full ingredients list and formulas proprietary, though we now know they often contained cocaine, opium, morphine, alcohol and other intoxicants or toxins.
Products like heroin cough drops and cocaine-laced toothache medicine were sold openly and freely over the counter, using colorful advertisements that can be downright shocking to modern eyes..
But more than that, widespread opiate use in Victorian America didn’t start with the patent medicines. It started with doctors.” (A)
“When I was in medical school, a professor instructed me to think of pain as the patient’s fifth vital sign. It was a radical, new idea, one that was quickly disseminating across the country, and it was supposed to alleviate suffering, improve outcomes and transform lives.
But as we discover in Beth Macy’s timely new book, “Dopesick: Dealers, Doctors, and the Drug Company That Addicted America” (Little, Brown, 376 pp., ★★★½ out of four), that approach was wildly misguided. It led to thousands of unnecessary deaths and created an underclass of marginalized and debilitated drug addicts. How could we have gotten this so wrong?
You’ve probably heard pieces of this story before, but in “Dopesick” we get something original: a page-turning explanation.
We begin in Appalachia, the epicenter of the opioid crisis, where “few businesses dare to set up shop because it’s hard to find workers who can pass a drug test.” It’s a place that feels forgotten, where Americans are dying in the prime of their lives and those who hang on are known as “pillbillies.”..
From there, the narrative moves to Stamford, Connecticut, and Purdue Frederick, a family-owned pharmaceutical company. In 1952, Purdue was purchased by brothers Raymond, Mortimer and Arthur Sackler – who transformed the small operation into a massive conglomerate called Purdue Pharma, cornering the pain-relief market with MS Contin and OxyContin.” (B)
“The letters arrived from the San Diego County medical examiner’s office, informing clinicians that one of their patients had died from a prescription drug overdose.
These letters appear to have had an impact — prescriptions of addictive painkillers dropped.
In a small, randomized trial, researchers showed that this intervention — aimed at making the abstract issue of safe prescribing individually tangible — led to a slight reduction in the amount of opioids these clinicians prescribed. What’s more, prescribers who received the letters doled out fewer of the most powerful doses and appeared to start fewer patients on opioids compared with doctors who did not receive the letters.
Authors of the study published Thursday and experts not involved with the research urged other communities around the country to adopt the same strategy.
“Hearing about one person’s death can be really impactful,” said Jason Doctor, the lead author of the study and an expert in behavioral science and policy at the University of Southern California. “People often don’t change their behavior unless they have a really salient, personal experience.”” (C)
“The Food and Drug Administration on Monday announced a shift in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments.
Now, rather than merely examining whether a potential treatment reduces opioid use, the agency will consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases.
“We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement.
The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment.” (D)
“A fast-acting class of fentanyl drugs approved only for cancer patients with high opioid tolerance has been prescribed frequently to patients with back pain and migraines, putting them at high risk of accidental overdose and death, according to documents collected by the Food and Drug Administration.
The F.D.A. established a distribution oversight program in 2011 to curb inappropriate use of the dangerous medications, but entrusted enforcement to a group of pharmaceutical companies that make and sell the drugs.
Some of the companies have been sued for illegally promoting other uses for the medications and in one case even bribing doctors to prescribe higher doses.
About 5,000 pages of documents, obtained by researchers at the Johns Hopkins Bloomberg School of Public Health through the Freedom of Information Act and provided to The New York Times, show that the F.D.A. had data showing that so-called off-label prescribing was widespread. But officials did little to intervene.” (E)
“Opioid addiction is an epidemic gripping the nation, leading to thousands of overdose deaths annually. But Dr. Kevin Zacharoff, an anesthesiologist with more than 25 years of experience in pain medicine, says opioids can also provide much-needed relief to many patients.
There are tens of thousands of people for whom opioids are the best form of treatment, Zacharoff told medical professionals and Long Islanders at a symposium at Stony Brook Medicine on Friday.
Rather than not prescribe opioids at all, Zacharoff believes there needs to be more discussion among health professionals and in medical schools about the risks and benefits of opioids as pain treatment. Currently, only about 4 percent of all medical schools in the country have curriculums dedicated to pain management and addiction, he said. Stony Brook is in the process of developing a curriculum for fourth-year medical students to be implemented next year on those topics, he said.
“The only thing that really concerns me is that we don’t throw the baby away with the bath water,” he said. “Opioids have been around for 4,000 years.”” (F)
“Addiction to prescription opioids like oxycodone has risen so rapidly in the last decade that now an average of 40 people die of overdoses in the U.S. each day, according to the Centers for Disease Control and Prevention (CDC). President Donald Trump declared opioid addiction a public health emergency last year, helping bring more attention to the crisis.
But newly published research led by the Mayo Clinic is raising serious questions about whether awareness of the dangers of opioid prescriptions is translating to fewer prescriptions and a reduction in use of the powerful painkillers.
Opioid prescription rates have remained flat for insured patients over the last 10 years, according to data published today in the BMJ. And even though prescriptions doled out to Medicare patients have recently shown signs of leveling, prescribing rates for some of those older people are actually higher than they were a decade ago.” (G)
“The New York State Department of Health recently began urging doctors prescribing opioids for patients with severe pain to consider medical marijuana as an alternative. The guidance was part of an emergency regulation that went into effect July 12.
The national opioid crisis on average causes 115 U.S. overdose deaths a day in the United States. New York has been focused on reducing its share of that toll. In 2016, opioids killed 18 of every 100,000 New Yorkers, according to the Centers for Disease Control and Prevention. New York’s State Health Commissioner Howard Zucker in June explained why the state is making this welcome move. “Medical marijuana has been shown to be an effective treatment for pain that may also reduce the chance of opioid dependence.”” (H)
“The new goal is pain elimination, which I believe is one factor that has fueled the overconsumption of opioids although there are other factors present…
But patients’ rising expectations of eliminating pain and the medical professions’ willingness to join in this mission has exacted a great societal cost. I am not blaming anyone here. Of course, patients want pain to go away. Of course, physicians want to relieve suffering. Isn’t a doctor’s mission to make his patient feel better?
Could this really result from a doctor’s prescription?
The consequences of this approach have exploded. Narcotics and opioids are addictive agents. Any individual who takes these medicines over time risks addiction, which is a new disease. In fact, the addiction may very well be a more severe illness than the original medical condition…
Consider this sobering statistic: The U.S. is about 5% of the world’s population yet consumes about 80% of the world’s oxycodone supply…
The medical profession and the scientific community need to triple down on research to develop new drugs and techniques that attack pain but leave patients protected from the ravages and misery of drug addiction.” “ (I)
(A) How Advertising Shaped the First Opioid Epidemic, by By Jon Kelvey, cdn.com/uUasjiYUx7Ife2mLvzZD61wklig=/800×600/filters:no_upscale()/https://public-media.smithsonianmag.com/filer/d7/d7/d7d7f166-3063-45f8-bf0c-d0bbf18e2362/vintage-advert-for-medicine.jpg
(B) ‘Dopesick’ is a page-turning look at the nation’s opioid crisis and big Pharma, by Matt McCarthy, https://www.usatoday.com/story/life/books/2018/08/06/dopesick-page-turning-look-nations-opioid-crisis-beth-macy-big-pharma-book-review/882892002/
(C) Clinicians were told their patient had died of an overdose. Then opioid prescribing dropped, by ANDREW JOSEPH, https://www.statnews.com/2018/08/09/opioid-prescribing-medical-examiner-letters-overdose/
(D) FDA will broaden how it evaluates new addiction treatment drugs, by LEV FACHER, https://www.statnews.com/2018/08/06/fda-expands-medication-assisted-treatment/?utm_source=STAT+Newsletters&utm_campaign=7daa54108e-DC_Diagnosis&utm_medium=email&utm_term=0_8cab1d7961-7daa54108e-149527969
(E) F.D.A. Did Not Intervene to Curb Risky Fentanyl Prescriptions, by Emily Baumgaertner, https://www.nytimes.com/2018/08/02/health/fda-fentanyl-opioid-epidemic-overdose-cancer.html
(F) Despite epidemic, doctor says opioids also help patients, by Janelle Griffith, https://www.newsday.com/news/health/stony-brook-medicine-symposium-opioids-1.20278189
(G) Opioid Prescribing Hasn’t Declined In The Last Decade Despite Addiction Crisis, by Arlene Weintraub, https://www.forbes.com/sites/arleneweintraub/2018/08/01/opioid-use-hasnt-declined-in-the-last-decade-despite-addiction-crisis/#430bb8945dec
(H) New York Points The Way In Dealing With Opioid Crisis, by Kevin Murphy, https://www.forbes.com/sites/kevinmurphy/2018/08/02/new-york-points-the-way-in-dealing-with-opioid-crisis/#5e1407f38f62
(I) The Misguided Expectation of Eliminating Pain, by Michael Kirsch, https://www.forbes.com/sites/kevinmurphy/2018/08/02/new-york-points-the-way-in-dealing-with-opioid-crisis/#5e1407f38f62
(J)
