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INFORMATION FOR TRANSPLANT PROFESSIONALS AND COMMUNITY MEMBERS REGARDING 2019 NOVEL CORONAVIRUS
The recent outbreak of a novel coronavirus (COVID-19) in Wuhan, Hubei Province, China and the finding of infection in many other countries including the United States has led to questions among transplant programs, Organ Procurement Organizations (OPOs) and patients. The Organ Procurement and Transplantation Network (OPTN) strives to provide up-to-date information to answer these questions and to provide guidance as needed. Accordingly, the OPTN Ad Hoc Donor Transmission Advisory Committee (DTAC), American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS), after careful review of information available from the Centers for Disease Control and Prevention (CDC), offers information to transplant programs and OPOs in light of these concerns. Please visit theOPTN website for more information.
The American Society of Transplantation recently conducted a Town Hall on guidances for transplant patients with regard to the COVID-19 pandemic. A video recording of the Town Hall is given below
Description of the Town Hall by the AST: A number of transplant organizations from around the world have partnered to develop this educational webinar for the organ donation and transplantation communities. Our goal is to share experiences to date and respond to your questions about the impact of COVID-19 on organ donation and transplantation.
Because transplant recipients take immunosuppressive drugs, they are at higher risk of infection from viruses such as cold or flu. To limit the possibility of being exposed to the coronavirus that causes COVID-19, transplant patients should follow the CDC’s tips to avoid catching or spreading germs, and contact their health care provider if they develop cold or flu-like symptoms. By being informed and taking your own personal precautions, you can help reduce your risk of coming in contact with the coronavirus that causes COVID-19. You can find more information and resources for kidney patients by visiting our special coronavirus webpage at KidneyFund.org/coronavirus. We’ll update the page with important information for kidney patients and their caregivers as the coronavirus crisis continues to unfold.
As part of the Harvard Medical School Series on Bioethics: author, clinician and professor Jerome Groopman, MD and Pamel Harzband, MD gave an online discussion of their book “Your Medical Mind”, a part of Harvard Medical School Center for Bioethics Program’s Critical Reading of Contemporary Books in Bioethics Series. The Contemporary Authors in Bioethics series brings together authors and the community to discuss books that explore new and developing topics in the field. This was held as an online Zoom meeting on March 26, 2020 at 5 pm EST and could be followed on Twitter using #HarvardBioethics. A recording of the discussion will be made available at the Harvard Med School Center for Bioethics.
Available at Amazon: From the Amazon book description:
An entirely new way to make the best medical decisions.
Making the right medical decisions is harder than ever. We are overwhelmed by information from all sides—whether our doctors’ recommendations, dissenting experts, confusing statistics, or testimonials on the Internet. Now Doctors Groopman and Hartzband reveal that each of us has a “medical mind,” a highly individual approach to weighing the risks and benefits of treatments. Are you a minimalist or a maximalist, a believer or a doubter, do you look for natural healing or the latest technology? The authors weave vivid narratives of real patients with insights from recent research to demonstrate the power of the medical mind. After reading this groundbreaking book, you will know how to arrive at choices that serve you best.
Doctors Groopman and Hartzband began the discussion with a recapping medical research studies and medical panels, which had reported conflicting results or reversal of recommendations, respectively. These included studies on the benefits of statin therapy in cholesterol management, studies on whether or not Vitamin D therapy is beneficial for postmenopausal women, the ongoing controversy on the frequency with which women should get mammograms, as well as the predictive value of Prostate Specific Antigen and prostate cancer screening. The authors singled out the research reports and medical panels reviewing the data on PSA in which the same medical panel first came out in support of using PSA levels to screen for prostate cancer and then later, after reconvening, recommended that PSA was not useful for mass screenings for prostate cancer.
In fact, both authors were
completed surprised of the diametrically opposed views within or between panels given similar data presented to those medical professionals.
The authors then asked a question: Why would the same medical panel come to a reversal of their decision and more, importantly, why are there such disparate conclusions from the same medical data sets, leading to varied clinical decision-making.
In general, Drs. Groopman and Hartzband asked how do physicians and patients make their decisions?
To answer this they looked at studies that Daniel Bernouli had conducted to model the economic behaviors of risk aversion in the marketplace. Bernouli’s theorem correlated market expectation with probability and outcomes
expectation = probability x utility of outcome
However, in medicine, one can measure probability (or risk) but it is very hard to measure utility (which is the value or worth of the outcome).
For example, they gave an example if a person was born blind but offered a risky to regain sight, the individual values their quality of life from their own perspective and might feel that, as their life is worthwhile as it is, they would not undergo a risky procedure. However a person who had suddenly lost their sight might value sight more, and be willing to undergo a risky procedure.
Three methods are used to put a value on utility or outcome worth with regards to medical decisions
linear scale (life or death; from 0 to 1)
time trade off: e.g. how much longer do I have to live
standard gamble: let’s try it
All of these methods however are flawed because one doesn’t know their future medical condition (e.g. new information on the disease) and people values and perceptions change over time.
An example of choice of methods the medical community uses to make decisions include:
In the United Kingdom, their system uses a time trade off method to determine value in order to determine appropriate course of action which may inadvertently, result in rationed care
in the United States, the medical community uses the time trade off to determine cost effectiveness
Therefore Drs. Groopman and Harztband, after conducing multiple interviews with patients and physicians were able to categorize medical decision making based on groups of mindsets
Maximalist: Proactive behavior, wants to stay ahead of the curve
Minimalist: less intervention is more; more hesitant to try any suggested therapy
Naturalist: more prone to choose natural based therapies or home remedies
Tech Oriented: wants to try the latest therapies and more apt to trust in branded and FDA approved therapeutics
Believer: trust in suggestions by physician; physician trusts medical panels suggestions
Doubter: naturally inquisitive and more prone to investigate risk benefits of any suggested therapy
The authors also identified many Cognitive Traps that both physicians and patients may fall into including:
Relative versus Absolute Numbers: for instance putting emphasis on one number or the other without regard to context; like looking at disease numbers without taking into consideration individual risk
Availability: availability or lack of available information; they noticed if you fall in this trap depends on whether you are a Minimalist or Maximalist
Framing: for example when people talk to others about their conditions and hear stories about others treatments, conditions .. mainly anecdotal evidence
Stories can be helpful but they sometimes increase our overestimation of risk or benefit so framing the information is very important for both the patient as well as the physician (even doctors as patients)
Both authors have noticed a big shift in US to minimalism probably because of the rising costs of healthcare.
How do these mindsets affect the patient-physician relationship?
A University of Michigan study revealed that patients who would be characterized as maximalists pushed their physicians to do more therapy and were more prone to seek outside advice.
Physicians need to understand and listen to their patients during the patients’s first visit and determine what medical mindset that this patient has.
About the authors:
Jerome Groopman, M.D. is the Dina and Raphael Recanati Professor of Medicine at Harvard Medical School, Chief of Experimental Medicine at Beth Israel Deaconess Medical Center, and one of the world’s leading researchers in cancer and AIDS. He is a staff writer for The New Yorker and has written for The New York Times, The Wall Street Journal,The Washington Post and The New Republic. He is author of The Measure of Our Days (1997), Second Opinions (2000), Anatomy of Hope (2004), How Doctors Think (2007), and the recently released, Your Medical Mind.
Dr. Pamela Hartzband is an Assistant Professor at the Harvard Medical School and Attending Physician in the Division of Endocrinology at the Beth Israel Deaconess Medical Center in Boston. She specializes in disorders of the thyroid and pituitary glands. A magna cum laude graduate of Radcliffe College, Harvard University, she received her M.D. from Harvard Medical School. She served her internship and residency in internal medicine at the Massachusetts General Hospital, and her specialty fellowships in endocrinology and metabolism at UCLA.
More articles on BioEthics and Patient experiences in this Online Open Access Journal Include:
The coronavirus pandemic has affected almost every country in every continent however, after months of the novel advent of novel COVID-19 cases, it has become apparent that the varied clinical responses in this epidemic (and outcomes) have laid bare some of the strong and weak aspects in, both our worldwide capabilities to respond to infectious outbreaks in a global coordinated response and in individual countries’ response to their localized epidemics.
Some nations, like Israel, have initiated a coordinated government-private-health system wide action plan and have shown success in limiting both new cases and COVID-19 related deaths. After the initial Wuhan China outbreak, China closed borders and the government initiated health related procedures including the building of new hospitals. As of writing today, Wuhan has experienced no new cases of COVID-19 for two straight days.
However, the response in the US has been perplexing and has highlighted some glaring problems that have been augmented in this crisis, in the view of this writer. In my view, which has been formulated after social discussion with members in the field ,these issues can be centered on three major areas of deficiencies in the United States that have hindered a rapid and successful response to this current crisis and potential future crises of this nature.
The mistrust or misunderstanding of science in the United States
Lack of communication and connection between patients and those involved in the healthcare industry
Socio-geographical inequalities within the US healthcare system
1. The mistrust or misunderstanding of science in the United States
For the past decade, anyone involved in science, whether directly as active bench scientists, regulatory scientists, scientists involved in science and health policy, or environmental scientists can attest to the constant pressure to not only defend their profession but also to defend the entire scientific process and community from an onslaught of misinformation, mistrust and anxiety toward the field of science. This can be seen in many of the editorials in scientific publications including the journal Science and Scientific American (as shown below)
Boston rally coincides with annual American Association for the Advancement of Science (AAAS) conference and is a precursor to the March for Science in Washington, D.C.
Responding to the troubling suppression of science under the Trump administration, thousands of scientists, allies, and frontline communities are holding a rally in Boston’s Copley Square on Sunday.
“Science serves the common good,” reads the call to action. “It protects the health of our communities, the safety of our families, the education of our children, the foundation of our economy and jobs, and the future we all want to live in and preserve for coming generations.”
It continues:
But it’s under attack—both science itself, and the unalienable rights that scientists help uphold and protect.
From the muzzling of scientists and government agencies, to the immigration ban, the deletion of scientific data, and the de-funding of public science, the erosion of our institutions of science is a dangerous direction for our country. Real people and communities bear the brunt of these actions.
The rally was planned to coincide with the annual American Association for the Advancement of Science (AAAS) conference, which draws thousands of science professionals, and is a precursor to the March for Science in Washington, D.C. and in cities around the world on April 22.
However, some feel that scientists are being too sensitive and that science policy and science-based decision making may not be under that much of a threat in this country. Yet even as some people think that there is no actual war on science and on scientists they realize that the public is not engaged in science and may not be sympathetic to the scientific process or trust scientists’ opinions.
Certainly, opponents of genetically modified crops, vaccinations that are required for children and climate science have become louder and more organized in recent times. But opponents typically live in separate camps and protest single issues, not science as a whole, said science historian and philosopher Roberta Millstein of the University of California, Davis. She spoke at a standing-room only panel session at the American Association for the Advancement of Science’s annual meeting, held in Washington, D.C. All the speakers advocated for a scientifically informed citizenry and public policy, and most discouraged broadly applied battle-themed rhetoric.
In general, it appears to be a major misunderstanding by the public of the scientific process, and principles of scientific discovery, which may be the fault of miscommunication by scientists or agendas which have the goals of subverting or misdirecting public policy decisions from scientific discourse and investigation.
This can lead to an information vacuum, which, in this age of rapid social media communication,
can quickly perpetuate misinformation.
This perpetuation of misinformation was very evident in a Twitter feed discussion with Dr. Eric Topol, M.D. (cardiologist and Founder and Director of the Scripps Research Translational Institute) on the US President’s tweet on the use of the antimalarial drug hydroxychloroquine based on President Trump referencing a single study in the International Journal of Antimicrobial Agents. The Twitter thread became a sort of “scientific journal club” with input from international scientists discussing and critiquing the results in the paper.
Please note that when we scientists CRITIQUE a paper it does not mean CRITICIZE it. A critique is merely an in depth analysis of the results and conclusions with an open discussion on the paper. This is part of the normal peer review process.
Below is the original Tweet by Dr. Eric Topol as well as the ensuing tweet thread
I reviewed the cited paperhttps://t.co/E4Iw7GpVh6 an open-label, non=randomized study The endpoint was viral PCR (mostly + or -, many ND) by nasopharyngeal swab. 6 of the 36 people were asymptomatic. 6 with pneumonia (LRTI) 6 people received "H + A" pic.twitter.com/KBjR1QcZRV
Eric – a huge issue here is they only report data on 20 of the 26 patients, and of the 6 – all deteriorated! Six hydroxychloroquine-treated patients were lost in follow-up: they worsened and weee sent to the ICU! They need to do last observation carried forward for those.
— Christopher Cannon, M.D. 🇺🇦 (@cpcannon) March 21, 2020
OMG, do you realize none of the patients in the treatment arm were definitive positives to start with? They were all in the "gray zone". JFC, this study was worse than I thought when I skimmed it the first time!
Within the tweet thread it was discussed some of the limitations or study design flaws of the referenced paper leading the scientists in this impromptu discussion that the study could not reasonably conclude that hydroxychloroquine was not a reliable therapeutic for this coronavirus strain.
The lesson:The public has to realizeCRITIQUE does not mean CRITICISM.
Scientific discourse has to occur to allow for the proper critique of results. When this is allowed science becomes better, more robust, and we protect ourselves from maybe heading down an incorrect path, which may have major impacts on a clinical outcome, in this case.
2. Lack of communication and connection between patients and those involved in the healthcare industry
In normal times, it is imperative for the patient-physician relationship to be intact in order for the physician to be able to communicate proper information to their patient during and after therapy/care. In these critical times, this relationship and good communication skills becomes even more important.
Recently, I have had multiple communications, either through Twitter, Facebook, and other social media outlets with cancer patients, cancer advocacy groups, and cancer survivorship forums concerning their risks of getting infected with the coronavirus and how they should handle various aspects of their therapy, whether they were currently undergoing therapy or just about to start chemotherapy. This made me realize that there were a huge subset of patients who were not receiving all the information and support they needed; namely patients who are immunocompromised.
These are patients represent
cancer patient undergoing/or about to start chemotherapy
Patients taking immunosuppressive drugs: organ transplant recipients, patients with autoimmune diseases, multiple sclerosis patients
Patients with immunodeficiency disorders
These concerns prompted me to write a posting curating the guidance from National Cancer Institute (NCI) designated cancer centers to cancer patients concerning their risk to COVID19 (which can be found here).
Surprisingly, there were only 14 of the 51 US NCI Cancer Centers which had posted guidance (either there own or from organizations like NCI or the National Cancer Coalition Network (NCCN). Most of the guidance to patients had stemmed from a paper written by Dr. Markham of the Fred Hutchinson Cancer Center in Seattle Washington, the first major US city which was impacted by COVID19.
Also I was surprised at the reactions to this posting, with patients and oncologists enthusiastic to discuss concerns around the coronavirus problem. This led to having additional contact with patients and oncologists who, as I was surprised, are not having these conversations with each other or are totally confused on courses of action during this pandemic. There was a true need for each party, both patients/caregivers and physicians/oncologists to be able to communicate with each other and disseminate good information.
Last night there was a Tweet conversation on Twitter #OTChat sponsored by @OncologyTimes. A few tweets are included below
The Lesson: Rapid Communication of Vital Information in times of stress is crucial in maintaining a good patient/physician relationship and preventing Misinformation.
3. Socio-geographical Inequalities in the US Healthcare System
It has become very clear that the US healthcare system is fractioned and multiple inequalities (based on race, sex, geography, socio-economic status, age) exist across the whole healthcare system. These inequalities are exacerbated in times of stress, especially when access to care is limited.
Some of the passengers had to be extricated from the wrecked cars. Many of the passengers and local residents helped first responders during the rescue operation. Five local hospitals treated the injured. The derailment disrupted train service for several days.
What was not reported was the difficulties that first responders, namely paramedics had in finding an emergency room capable of taking on the massive load of patients. In the years prior to this accident, several hospitals, due to monetary reasons, had to close their emergency rooms or reduce them in size. In addition only two in Philadelphia were capable of accepting gun shot victims (Temple University Hospital was the closest to the derailment but one of the emergency rooms which would accept gun shot victims. This was important as Temple University ER, being in North Philadelphia, is usually very busy on any given night. The stress to the local health system revealed how one disaster could easily overburden many hospitals.
Over the past decade many hospitals, especially rural hospitals, have been shuttered or consolidated into bigger health systems. The graphic below shows this
Note the huge swath of hospital closures in the midwest, especially in rural areas. This has become an ongoing problem as the health care system deals with rising costs.
Lesson:Epidemic Stresses an already stressed out US healthcare system
One of Alaska’s first confirmed coronavirus patients tells his story
March 19, 2020
A Ketchikan man who contracted the illness caused by the new coronavirus is speaking out about his experience.
In a social media post and an interview with the Ketchikan Daily News, he described his symptoms, how he was tested and his experience communicating with Alaska public health officials.
Brown said in a Facebook post that he was feeling better and was notified by public health officials that he’d tested positive for COVID-19 on Tuesday afternoon.
“I became sick Saturday morning with fever, headache, general achiness and chills,” Brown wrote.
Brown said he has “no idea” how he contracted the illness.
“I interacted with no one in recent weeks who was exhibiting obvious symptoms,” he wrote.
According to a statement Tuesday from the Ketchikan Emergency Operations Center saying one of its employees tested positive for the virus, the employee had a history of travel to the Lower 48. The Ketchikan Emergency Operations Center on Wednesday confirmed Brown is the employee.
After public health officials told Brown his diagnosis, he said that he went through more than an hour of questions with them, he told the Ketchikan Daily News.
“I used everything from cellphone records to work calendars to debit card bills, to recall everybody that I may have had contact with,” Brown told the Ketchikan Daily News. “I wanted to provide that information to public health, (so) that they could alert those people and really hope to kind of arrest this thing.”
Brown told the paper that public health officials focused on two days before he developed symptoms of the illness. Brown had been “working closely with borough staff and upper management” in those days as part of his job, the paper reported.
“I apologize for causing undue concern for anyone, especially my co-workers at the Borough,” Brown said in the Facebook post.
Ketchikan Gateway Borough employees in direct contact with Brown were instructed to self-quarantine for two weeks, according to the Ketchikan Emergency Operations Center statement.
The statement also said that the borough had hired a service to disinfect the now-closed White Cliff Building, which houses the Ketchikan Borough offices.
According to the Ketchikan Daily News, the last time Brown was at the borough’s White Cliff Building was Friday.
The paper reported that as of Tuesday night, there were no plans to test people who had been in direct contact with Brown.
A public information officer for Ketchikan’s Emergency Operations Center told the Ketchikan Daily News that she understood that to be tested, people would need to have “several” symptoms of the virus.
“I would also ask that you join me and all of Ketchikan to actively minimize community transmission so that we can protect our seniors or other medically vulnerable folks in Ketchikan,” Brown wrote. “I pray that we all make it through this largely unharmed, and together.”
The first person in Alaska to test positive for COVID-19 was an air cargo pilot who arrivedat Ted Stevens Anchorage International Airport on March 11, officials announced last week. He went through the airport’s North Terminal, which is separate from the domestic terminal.
Alaska’s chief medical officer, Dr. Anne Zink, said last week the man had self-isolated and was “stable.”
On Monday, officials said two older men in Fairbanks were diagnosed with the illness. Both had recently traveled to the Lower 48, Zink said, but were not traveling together.
In addition to the Anchorage case, the case in Ketchikan and the two in Fairbanks, officials on Tuesday announced that two more people had become sick with the virus — one in Fairbanks and one in Anchorage — bringing the total number of confirmed cases as of Wednesday morning to six.
Zink said that both of those cases were also travel-related. None of the three people who tested positive for COVID-19 on Tuesday were hospitalized, Zink said.
Fairbanks Memorial Hospital released a statement Tuesday saying a woman with a history of recent travel had tested positive for COVID-19.
“She self-isolated prior to testing,” the statement said. “This patient has been notified and is in stable condition and does not require hospitalization.”
A University of Alaska Fairbanks employee was one of the people who had recently tested positive for the virus in Alaska, university officials said Tuesday.
State and local officials have taken a series of steps to stem the spread of COVID-19 in Alaska, including closing schools, calling on hospitals to halt elective surgeries and shutting down dine-in service at all restaurants, bars, breweries, cafes and similar businesses.
Morgan Krakow is a general assignment reporter for the Anchorage Daily News. She is a 2019 graduate of the University of Oregon and spent the past summer as a reporting intern on the general assignment desk of The Washington Post. Contact her at mkrakow@adn.com.
Responses to the #COVID-19 outbreak from Oncologists, Cancer Societies and the NCI: Important information for cancer patients
Curator: Stephen J. Williams, Ph.D.
UPDATED 3/20/2020
Among the people who are identified at risk of coronovirus 2019 infection and complications of the virus include cancer patients undergoing chemotherapy, who in general, can be immunosuppressed, especially while patients are undergoing their treatment. This has created anxiety among many cancer patients as well as their care givers and prompted many oncologist professional groups, cancer societies, and cancer centers to formulate some sort of guidelines for both the cancer patients and the oncology professional with respect to limiting the risk of infection to coronavirus (COVID19).
This information will be periodically updated and we are working to get a Live Twitter Feed to bring oncologist and cancer patient advocacy groups together so up to date information can be communicated rapidly. Please see this page regularly for updates as new information is curated.
IN ADDITION, I will curate a listing of drugs with adverse events of immunosuppression for people who might wonder if the medications they are taking are raising their risk of infections.
From the Cancer Letter:The following is a guest editorial by American Society of Clinical Oncology (ASCO) Executive Vice President and Chief Medical Officer Richard L. Schilsky MD, FACP, FSCT, FASCO. This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
The worldwide spread of the coronavirus (COVID-19) presents unprecedented challenges to the cancer care delivery system.
Our patients are already dealing with a life-threatening illness and are particularly vulnerable to this viral infection, which can be even more deadly for them.Further, as restrictions in daily movement and social distancing take hold, vulnerable patients may be disconnected from friends, family or other support they need as they manage their cancer.
As providers, we rely on evidence and experience when treating patients but now we face uncertainty. There are limited data to guide us in the specific management of cancer patients confronting COVID-19 and, at present, we have no population-level guidance regarding acceptable or appropriate adjustments of treatment and practice operations that both ensure the best outcome for our patients and protect the safety of our colleagues and staff.
As normal life is dramatically changed, we are all feeling anxious about the extreme economic challenges we face, but these issues are perhaps even more difficult for our patients, many of whom are now facing interruption
As we confront this extraordinary situation, the health and safety of members, staff, and individuals with cancer—in fact, the entire cancer community—is ASCO’s highest priority.
ASCO has been actively monitoring and responding to the pandemic to ensure that accurate information is readily available to clinicians and their patients. Recognizing that this is a rapidly evolving situation and that limited oncology-specific, evidence-based information is available, we are committed to sharing what is known and acknowledging what is unknown so that the most informed decisions can be made.
To help guide oncology professionals as they deal with the impact of coronavirus on both their patients and staff, ASCO has collated questions from its members, postedresponses at asco.organd assembled a compendium of additional resources we hope will be helpful as the virus spreads and the disease unfolds. We continue to receive additional questions regarding clinical care and we are updating our FAQs on a regular basis.
We hope this information is helpful even when it merely confirms that there are no certain answers to many questions. Our answers are based on the best available information we identify in the literature, guidance from public health authorities, and input received from oncology and infectious disease experts.
For patients, we have posted a blog byDr. Merry Jennifer Markham, chair of ASCO’s Cancer Communications Committee. This can be found onCancer.Net, ASCO’s patient information website, and it provides practical guidance to help patients reduce their risk of exposure, better understand COVID-19 symptoms, and locate additional information.
This blog is available both in English and Spanish. Additional blog posts addressing patient questions will be posted as new questions are received and new information becomes available.
Find below a Tweet from Dr.Markham which includes links to her article on COVID-19 for cancer patients
JNCCN: How to Manage Cancer Care during COVID-19 Pandemic
Experts from the Seattle Cancer Care Alliance (SCCA)—a Member Institution of the National Comprehensive Cancer Network® (NCCN®)—are sharing insights and advice on how to continue providing optimal cancer care during the novel coronavirus (COVID-19) pandemic. SCCA includes the Fred Hutchinson Cancer Research Center and the University of Washington, which are located in the epicenter of the COVID-19 outbreak in the United States. The peer-reviewed article sharing best practices is available for free online-ahead-of-print via open access at JNCCN.org.
Coronavirus disease 2019 (COVID-19) Resources for the Cancer Care Community
NCCN recognizes the rapidly changing medical information relating to COVID-19 in the oncology ecosystem, but understands that a forum for sharing best practices and specific institutional responses may be helpful to others. Therefore, we are expeditiously providing documents and recommendations developed by NCCN Member Institutions or Guideline Panels as resources for oncology care providers. These resources have not been developed or reviewed by the standard NCCN processes, and are provided for information purposes only. We will post more resources as they become available so check back for additional updates.
Both the resources at cancer.gov (NCI) as well as the resources from ASCO are updated as new information is evaluated and more guidelines are formulated by members of the oncologist and cancer care community and are excellent resources for those living with cancer, and also those who either care for cancer patients or their family and relatives.
Related Resources for Patients (please click on links)
@DrMarkham Dr. Markham is Chief of Heme-Onc & gyn med onc@UF | AD Med Affairs@UFHealthCancerand has collected very good information for patients concerning #Covid19
Cancer patients on chemotherapy concerned about traveling for treatment during the #COVID19 crisis may have another option. Find out about the pros and cons of taking an oral medication. https://t.co/4djwfji5WR#CTCABlog
— CTCA, part of City of Hope (@CancerCenter) March 19, 2020
UPDATED 3/20/2020 INFORMATION FROM NCI DESIGNATED CANCER CENTERS FOR PATIENTS/PROVIDERS
The following is a listing with links of NCI Designated Comprehensive Cancer Centers and some select designated Cancer Centers* which have information on infectious risk guidance for cancer patients as well as their physicians and caregivers. There are 51 NCI Comprehensive Cancer Centers and as more cancer centers formulate guidance this list will be updated.
The webinar started with a brief introduction of attendees , most who are breast cancer survivors. Survivingbreastcancer.org is an organization committed to supplying women affected with breast cancer up to date information, including podcasts, webinars, and information for treatment, care, and finding support and support groups.
Some of the comments of survivors:
being strong
making sure to not feel overwhelmed on initial diagnosis
get good information
sometimes patients have to know to ask for genetic testing as physicians may not offer it
Laura Carfang discussed her study results presented at a bioethics conference in Clearwater, FL on issues driving breast cancer patient’s as well as at-risk women’s decision making process for genetic testing. The study was a phenomenological study in order to determine, through personal lived experiences, what are pivotal choices to make genetic testing decisions in order to improve clinical practice.
The research involved in depth interviews with 6 breast cancer patients (all women) who had undergone breast cancer genetic testing.
Main themes coming from the interviews
information informing decisions before diagnosis: they did not have an in depth knowledge of cancer or genetics or their inherent risk before the diagnosis.
these are my genes and I should own it: another common theme among women who were just diagnosed and contemplating whether or not to have genetic testing
information contributing to decision making after diagnosis: women wanted the option, and they wanted to know if they carry certain genetic mutations and how it would guide their own personal decision to choose the therapy they are most comfortable with and gives them the best chance to treat their cancer (the decision and choice is very personal)
communicating to family members and children was difficult for the individual affected; women found that there were so many ramifications about talking with family members (how do I tell children, do family members really empathize with what I am going through). Once women were tested they felt a great strain because they now were more concerned with who in their family (daughters) were at risk versus when they first get the diagnosis the bigger concern was obtaining information.
Decision making to undergo genetic testing not always linear but a nonlinear process where women went from wanting to get tested for the information to not wanting to get tested for reasons surrounding negative concerns surrounding knowing results (discrimination based on results, fear of telling family members)
Complex decision making involves a shift or alteration in emotion
The Mayo Clinic has come out with full support of genetic testing and offer to any patient.
Additional resources discussed was a book by Leslie Ferris Yerger “Probably Benign” which discusses misdiagnoses especially when a test comes back as “probably benign” and how she found it was not.
This article is excerpted from the Harvard Business Review, May 28, 2019
By Moni Miyashita, Michael Brady
3.4.13 The Health Care Benefits of Combining Wearables and AI, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 3: AI in Medicine
In southeast England, patients discharged from a group of hospitals serving 500,000 people are being fitted with a Wi-Fi-enabled armband that remotely monitors vital signs such as respiratory rate, oxygen levels, pulse, blood pressure, and body temperature.
Under a National Health Service pilot program that now incorporates artificial intelligence to analyze all that patient data in real time, hospital readmission rates are down, and emergency room visits have been reduced. What’s more, the need for costly home visits has dropped by 22%. Longer term, adherence to treatment plans have increased to 96%, compared to the industry average of 50%.
The AI pilot is targeting what Harvard Business School Professor and Innosight co-founder Clay Christensen calls “non-consumption.” These are opportunity areas where consumers have a job to be done that isn’t currently addressed by an affordable or convenient solution.
Before the U.K. pilot at the Dartford and Gravesham hospitals, for instance, home monitoring had involved dispatching hospital staffers to drive up to 90 minutes round-trip to check in with patients in their homes about once per week. But with algorithms now constantly searching for warning signs in the data and alerting both patients and professionals instantly, a new capability is born: providing healthcare before you knew you even need it.
The biggest promise of artificial intelligence — accurate predictions at near-zero marginal cost — has rightly generated substantial interest in applying AI to nearly every area of healthcare. But not every application of AI in healthcare is equally well-suited to benefit. Moreover, very few applications serve as an appropriate strategic response to the largest problems facing nearly every health system: decentralization and margin pressure.
Take for example, medical imaging AI tools — an area in which hospitals are projected to spend $2 billion annually within four years. Accurately diagnosing diseases from cancers to cataracts is a complex task, with difficult-to-quantify but typically major consequences. However, the task is currently typically part of larger workflows performed by extensively trained, highly specialized physicians who are among some of the world’s best minds. These doctors might need help at the margins, but this is a job already being done. Such factors make disease diagnosis an extraordinarily difficult area for AI to create transformative change. And so the application of AI in such settings — even if beneficial to patient outcomes — is unlikely to fundamentally improve the way healthcare is delivered or to substantially lower costs in the near-term.
However, leading organizations seeking to decentralize care can deploy AI to do things that have never been done before. For example: There’s a wide array of non-acute health decisions that consumers make daily. These decisions do not warrant the attention of a skilled clinician but ultimately play a large role in determining patient’s health — and ultimately the cost of healthcare.
According to the World Health Organization, 60% of related factors to individual health and quality of life are correlated to lifestyle choices, including taking prescriptions such as blood-pressure medications correctly, getting exercise, and reducing stress. Aided by AI-driven models, it is now possible to provide patients with interventions and reminders throughout this day-to-day process based on changes to the patient’s vital signs.
Home health monitoring itself isn’t new. Active programs and pilot studies are underway through leading institutions ranging from Partners Healthcare, United Healthcare, and the Johns Hopkins School of Medicine, with positive results. But those efforts have yet to harness AI to make better judgements and recommendations in real time. Because of the massive volumes of data involved, machine learning algorithms are particularly well suited to scaling that task for large populations. After all, large sets of data are what power AI by making those algorithms smarter.
By deploying AI, for instance, the NHS program is not only able to scale up in the U.K. but also internationally. Current Health, the venture-capital backed maker of the patient monitoring devices used in the program, recently received FDA clearance to pilot the system in the U.S. and is now testing it with New York’s Mount Sinai Hospital. It’s part of an effort to reduce patient readmissions, which costs U.S. hospitals about $40 billion annually.
The early success of such efforts drives home three lessons in using AI to address non-consumption in the new world of patient-centric healthcare:
1) Focus on impacting critical metrics – for example, reducing costly hospital readmission rates.
Start small to home in on the goal of making an impact on a key metric tied to both patient outcomes and financial sustainability. As in the U.K. pilot, this can be done through a program with select hospitals or provider locations. In another case Grady Hospital, the largest public hospital in Atlanta, points to $4M in saving from reduced readmission rates by 31% over two years thanks to the adoption of an AI tool which identifies ‘at-risk’ patients. The system alerts clinical teams to initiate special patient touch points and interventions.
2) Reduce risk by relying on new kinds of partners.
Don’t try to do everything alone. Instead, form alliances with partners that are aiming to tackle similar problems. Consider the Synaptic Healthcare Alliance, a collaborative pilot program between Aetna, Ascension, Humana, Optum, and others. The alliance is using Blockchain to create a giant dataset across various health care providers, with AI trials on the data getting underway. The aim is to streamline health care provider data management with the goal of reducing the cost of processing claims while also improving access to care. Going it alone can be risky due to data incompatibility issues alone. For instance, the M.D. Anderson Cancer Center had to write off millions in costs for a failed AI project due in part to incompatibility with its electronic health records system. By joining forces, Synaptic’s dataset will be in a standard format that makes records and results transportable.
3) Use AI to collaborate, not compete, with highly-trained professionals.
Clinicians are often looking to augment their knowledge and reasoning, and AI can help. Many medical AI applications do actually compete with doctors. In radiology, for instance, some algorithms have performed image-bases diagnosis as well as or better than human experts. Yet it’s unclear if patients and medical institutions will trust AI to automate that job entirely. A University of California at San Diego pilot in which AI successfully diagnosed childhood diseases more accurately than junior-level pediatricians still required senior doctors to personally review and sign off on the diagnosis. The real aim is always going to be to use AI to collaborate with clinicians seeking higher precision — not try to replace them.
MIT and MGH have developed a deep learning model which identifies patients likely to develop breast cancer in the future. Learning from data on 60,000 prior patients, the AI system allows physicians to personalize their approach to breast cancer screening, essentially creating a detailed risk profile for each patient.
Taken together, these three lessons paired with solutions targeted at non-consumption have the potential to provide a clear path to effectively harnessing a technology that has been subject to rampant over-promising. Longer term, we believe the one of the transformative benefits of AI will be deepening relationships between health providers and patients. The U.K. pilot, for instance, is resulting in more frequent proactive check-ins that never would have happened before. That’s good for both improving health as well as customer loyalty in the emerging consumer-centric healthcare marketplace.
The role of the patient has evolved dramatically over the past decade. Not only are patients increasingly more involved in their healthcare decision making, they are also passionate advocates who work tirelessly to advance drug development research and development and secure a public policy environment that is patient-centric. Join a discussion with patient advocates as they discuss their journeys to diagnosis and their viewpoints on our healthcare system. They will share their perspectives on what it means to be a patient and how they are advocating in their own unique ways to achieve a common goal: bringing new treatments to patients.
Christopher Anselmo: affected by MS but did not understand why he should be involved in a study at the time or share your story but he saw others who benefited from both of these and now is fervent patient advocate. Each patient is worth their weight in gold as needed for other patient support. The why needs to be asked of oneself before go out to other patients or into new trials. Might not see through to end if don’t have that discussion of why doing this.
Eve Bukowski: she had stomach aches, went to hospital, and diagnosed with constipation, but had stage III colon cancer. She was campaigning for Hillary Clinton but then started to campaign for her life. She wound up having multiple therapies and even many I/O trials. Fighting cancer is a mental challenge. She has been fighting for eleven years but has an amazing strength and will.
Emily Kramer: cystic fibrosis patient. Advocates for research as she has a mutant allele (nonsense mut) that is not targeted by the current new therapy against known mutants of CFTR. So started Emily’s Entourage for this orphan of an orphan disease. Funded $4 million in grants and helped develop a new startup and get early seed funding. Noticed that the infrastructure to get these drugs to market was broken and also is investing to shore up these breaks in drug pipeline infrastructure for orphan diseases. For progressive diseases she would like drug developers to shift the timelines or speed with which they get to take a chance and try that new possibility. As a patient advocacy org, they want to partner every step of the way with biotech/pharma, they understand co’s and stakeholders can only do so much but let’s break out of convention.
Julie: many patient advocacy groups go person to person and make a support network.
Real Time Coverage @BIOConvention #BIO2019: After Trump’s Drug Pricing Blueprint: What Happens Next? A View from Washington; June 3 2019 1:00 PM Philadelphia PA
Dan Todd is the Principal of Todd Strategy, LLC, a consulting firm founded in 2014 and based in Washington, DC. He provides legislative and regulatory strategic guidance and advocacy for healthcare stakeholders impacted by federal healthcare programs.
Prior to Todd Strategy, Mr. Todd was a Senior Healthcare Counsel for the Republican staff of the Senate Finance Committee, the Committee of jurisdiction for the Medicare and Medicaid programs. His areas of responsibility for the committee included the Medicare Part B and Part D programs, which includes physician, medical device, diagnostic and biopharmaceutical issues.
Before joining the Finance Committee, Mr. Todd spent several years in the biotechnology industry, where he led policy development and government affairs strategy. He also represented his companies’ interests with major trade associations such as PhRMA and BIO before federal and state representatives, as well as with key stakeholders such as physician and patient advocacy organizations.
Dan also served as a Special Assistant in the Office of the Administrator at the Centers for Medicare & Medicaid Services (CMS), the federal agency charged with the operation of the Medicare and Medicaid programs. While at CMS, Dan worked on Medicare Part B and Part D issues during the implementation of the Medicare Modernization Act from 2003 to 2005.
Cost efficiencies were never measured.
Removing drug rebates would cost 180 billion over 10 years. CBO came up with similar estimate. Not sure what Congress will do. It appears they will keep the rebates in.
House Dems are really going after PBMs; anytime the Administration makes a proposal goes right into CBO baseline estimates; negotiations appear to be in very early stages and estimates are up in the air
WH close to meet a budget cap but then broke down in next day; total confusion in DC on budget; healthcare is now held up, especially the REBATE rule; : is a shame as panel agrees cost savings would be huge
they had initiated a study to tie the costs of PartB to international drug prices; meant to get at disparity on international drug prices; they currently are only mulling the international price index; other option is to reform Part B; the proposed models were brought out near 2016 elections so not much done; unified agenda;
most of the response of Congress relatively publicly muted; a flat fee program on biologics will have big effect on how physicians and health systems paid; very cat and mouse game in DC around drug pricing
administration is thinking of a PartB “inflation cap”; committees are looking at it seriously; not a rebate; discussion of tiering of physician payments
Ways and Means Cmmtte: proposing in budget to alleve some stresses on PartB deductable amounts;
PartD: looking at ways to shore it up; insurers 80% taxpayers 20% responsible; insurers think it will increase premiums but others think will reduce catastrophic costs; big part of shift in spending in Part D has been this increase in catastrophic costs
this week they may actually move through committees on this issue; Administration trying to use the budgetary process to drive this bargain; however there will have to be offsets so there may be delays in process
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PEER-REVIEWED MEDICAL JOURNAL PUBLISHES LANDMARK STUDY ON EFFICACY AND SAFETY OF FDgard® (COLM-SST), DEMONSTRATING RAPID REDUCTION OF FUNCTIONAL DYSPEPSIA (FD OR RECURRING, MEAL-TRIGGERED INDIGESTION) SYMPTOMS WITHIN 24 HOURS
FDgard® (COLM-SST), a solid-state microsphere formulation of caraway oil and
l-Menthol, taken daily and proactively 30-60 minutes before meals, showed
statistically significant, rapid reduction of Functional Dyspepsia (FD)
symptoms within 24 hours and, additionally, relief of severe FD symptoms.
FDREST™ clinical trial with FDgard
represents an important medical advance, as no previous trials have shown rapid
relief of FD symptoms. There are no approved products for this highly prevalent
condition.
In FDREST, patients
received greater and more durable benefits with the addition of FDgard taken
daily and proactively to their typical medical regimen.
FDREST is the first
clinical trial in FD to use patented, Site
Specific Targeting (SST®) technology to deliver the FDgard
formulation to the upper belly (duodenum), the primary site of disturbance in
FD.
FDgard represents an
effective, safe and well-tolerated option to address the unmet medical needs of
millions of adults with FD.
Reporter: Gail S. Thornton
Boca Raton Fl., – (April 30, 2019) – IM HealthScience today announced that Clinical and Translational Gastroenterology (CTG), a peer-reviewed medical journal, has published the U.S. results of a landmark, double-blind, placebo-controlled study, FDREST™ (Functional Dyspepsia Reduction Evaluation and Safety Trial), which showed statistically significant, rapid reduction of Functional Dyspepsia (FD or recurring, meal-triggered indigestion) symptoms within 24 hours and, additionally, relief of severe FD symptoms.
The
FDREST study demonstrated that patients who took COLM-SST (FDgard®) on a daily
and proactive basis, 30 to 60 minutes before meals, along with commonly used
off-label FD medications versus patients who took placebo along with commonly
used off-label FD medications, experienced a statistically significant, rapid
reduction of FD symptoms within 24 hours across the FD study population.
This
study had a higher hurdle than previous studies on a similar combination of
ingredients. Firstly, concomitant medications for FD symptoms were allowed in
order to assess FDgard in a real-world setting. Second, only a subgroup of
patients in FDREST was categorized into the high-symptom burden, while they
constituted the entire groups in previous studies. Among this subgroup of
patients with the high-symptom burden, FDgard showed efficacy at 24 hours. In
spite of the polypharmacy and use of rescue medications for FD, after 48 hours
of first dose, FDgard helped further improve symptoms at 4 weeks, especially in
those high-symptom burden patients. In all cases, FDgard was safe and well-tolerated.
The
study results of FDREST were first presented at Digestive Disease Week (DDW),
the largest gathering of gastroenterologists, in May 2017.
Study Commentary
Commenting on the study, lead author William Chey, M.D., FACG, Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, said, “This landmark study was designed to answer a very important scientific question about the effectiveness, safety, and tolerability of a novel and innovative formulation of caraway oil and l-Menthol designed as solid state, enteric coated microspheres for targeted duodenal release for FD. In patients taking their usual medications for FD, FDgard was found to be effective, safe and well tolerated in rapidly reducing symptoms and in relieving severe symptoms.” Chey continued, “The positive finding at 24 hours is clinically important as symptoms are often triggered by a meal and patients are looking for rapid relief of those symptoms.”
The
study authors also cited the importance of utilizing the microsphere-based
site-specific targeting of FDgard (caraway oil and l-Menthol, the active
ingredient in peppermint oil) to the duodenum. They wrote, “This site
(duodenum) was targeted primarily due to mounting evidence that gastroduodenal
mucosal integrity and low-grade inflammation play a role in FD. Furthermore,
studies have shown that caraway oil and peppermint oil act on the duodenum to
induce smooth muscle relaxation, and that l-Menthol has anti-inflammatory
effects.” This may help normalize motility effects.
About FDREST™
FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial) was a multi-centered, post-marketing, parallel group,
U.S-based study conducted at seven university-based or gastroenterology
research-based centers (study period July 1, 2015, to September 14, 2016). The
study was designed to compare the efficacy, safety and tolerability of FDgard
plus commonly used, off-label medications for FD vs. a control group of placebo
plus commonly used, off-label medications prescribed for FD.
Ninety-five patients were enrolled
(mean age = 43.4 years; 75.8 percent women). At 24 hours, the active arm
reported a statistically significant reduction in Postprandial Distress Syndrome
(PDS) symptoms (P = 0.039), and a
nonsignificant trend toward benefit of Epigastric Pain Syndrome (EPS) symptoms
(P = 0.074). In patients with more
severe symptoms, approximately three-quarters showed substantial global
improvement (i.e., clinical global impressions) after 4 weeks of treatment vs.
half in the control arm. These differences were statistically significant for
patients with EPS symptoms (epigastric pain or discomfort and burning) (P = 0.046), and trending toward
significance for patients with PDS symptoms (early satiety, abdominal
heaviness, pressure and fullness) (P
= 0.091). There were no statistically significant differences between groups
for Global Overall Symptom scores for the overall population at 2 and 4 weeks.
Dr. Chey said, “The results of this
high-quality study highlight an advance in the management of FD, as current
off-label medications such as PPIs, H2RAs and antidepressants offer only a
modest level of therapeutic gain over placebo and may be associated with
adverse events, especially with continued use. FDgard addresses a significant
unmet medical need for a product to help manage symptoms in the 1 in 6 adults
suffering from this common disorder.”
About Functional
Dyspepsia (FD)
Functional
dyspepsia is a very common disorder affecting 11 percent – 29.2 percent of the
world’s population1, making it comparable in prevalence to IBS. However,
unlike IBS, there is no FDA approved product to treat FD. Sufferers are often
treated off-label with prescribed proton pump inhibitors (PPIs), histamine
type-2 receptor antagonists (H2RAs), antidepressants, and prokinetics. While
offering relief to a portion of FD patients, some of these have been associated
with adverse events. Functional dyspepsia can have a negative effect on
workplace attendance and productivity, with associated costs estimated in
excess of $18 billion annually.2
In
FD, which is typically recurring, meal-triggered indigestion with no known
organic cause, the normal digestive processes are disrupted along with
digestion and absorption of food nutrients. FD is accompanied by symptoms such
as epigastric pain or discomfort, epigastric burning, postprandial fullness,
inability to finish a normal sized meal, heaviness, pressure, bloating in the
upper abdomen, nausea, and belching. When doctors diagnose FD, they often
identify patients as those who have these symptoms for at least three months,
with symptom onset six months previously.
About FDgard®
FDgard® is a
nonprescription medical food designed to address the unmet medical need for
products to help manage Functional Dyspepsia (FD or recurring, meal-triggered
indigestion) and its accompanying symptoms. FDgard capsules contain
caraway oil and l-Menthol, the primary component in peppermint oil, for the
dietary management of FD. These two main ingredients are specially formulated
to be available in a solid state. With
patented Site Specific Targeting (SST®) technology pioneered by IM
HealthScience, FDgard capsules release individually triple-coated, solid-state
microspheres of caraway oil and l-Menthol quickly and reliably where they are
needed most in FD — the duodenum or upper belly. The l-Menthol helps with
smooth muscle relaxation and provides analgesic and anti-inflammatory
activities.3–5 Caraway oil helps mitigate the effect of gastric acid on
the stomach wall and also helps to normalize gallbladder function and may help
to normalize motility in the small intestine (primarily the duodenum) and in
the stomach.6,7 In addition to caraway oil and l-Menthol, FDgard also
provides fiber and amino acids (from gelatin protein). These ingredients have
additional positive effects on the gut wall and thus help toward normalizing
digestion and absorption.
Caraway
oil and peppermint oil have a history of working in FD. In multiple clinical
studies, the combination of caraway oil and peppermint oil has been shown to
manage FD and its accompanying symptoms, such as reducing the intensity of
epigastric pain, pain frequency, dyspeptic discomfort, and the intensity of
sensations of pressure, abdominal heaviness and fullness significantly better
than control.8,9 Cisapride, no longer an FDA-approved pro-motility drug
after its removal from the market in 2000 due to cardiovascular side effects,
was shown to have efficacy similar to a caraway oil/peppermint oil formulation10.
Complete
and final results from a real-world, observational study of 600 patients who
took FDgard, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), were selected after peer
review and presented by William D. Chey, M.D., FACG, at the World Congress of
Gastroenterology at ACG 2017 in Orlando, Florida. The data showed there was a
consistently high level of patient satisfaction and rapid improvement of FD
symptoms with the product. A majority of patients (95 percent) reported major
or moderate improvement in their overall FD symptoms, while many patients (86.4
percent) indicated experiencing relief from symptoms within 2 hours after
taking FDgard. The findings from FDACT
substantiate the data reported in FDREST.
The usual adult dose of
FDgard is 2 capsules, as needed, up to two times a day, not to exceed six
capsules per day. Many physicians are now recommending taking FDgard daily and
proactively 30-60 minutes before a meal, as this enables the supportive effect
of FDgard to start as early as possible. While FDgard does not require a
prescription and is available in retail outlets and online, it is a medical
food that should be used under medical supervision.
About IM HealthScience®
IM
HealthScience® (IMH) is the innovator of IBgard®and
FDgard®for the dietary management of Irritable Bowel Syndrome
(IBS) and Functional Dyspepsia (FD or recurring, meal-triggered indigestion),
respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic
fibers, to its product line via an acquisition. The sister subsidiary of IMH,
Physician’s Seal®, also provides REMfresh®,
a
well-known continuous release and absorption melatonin
(CRA-melatonin™) supplement for sleep.
IMH is a privately held company based in Boca
Raton, Florida. It was founded in 2010 by a team of highly experienced
pharmaceutical research and development and management executives. The company
is dedicated to developing products to address overall health and wellness,
especially in digestive health conditions with a high unmet medical need. The
IM HealthScience advantage comes from developing products based on its
patented, targeted-delivery technologies called Site Specific Targeting (SST).
For more information, visit www.imhealthscience.com to learn about
the company, or www.IBgard.com,
1. Mahadeva S, Goh KL. Epidemiology of
functional dyspepsia. A global perspective. World J Gastroenterol. 2006.
doi:10.3748/wjg.v12.i17.2661.
2. Lacy BE, Weiser KT, Kennedy AT, Crowell
MD, Talley NJ. Functional dyspepsia: the economic impact to patients. Aliment
Pharmacol Ther. 2013;38(May):170-177. doi:10.1111/apt.12355.
3. Amato A, Liotta R, Mulè F. Effects of
menthol on circular smooth muscle of human colon: Analysis of the mechanism of
action. Eur J Pharmacol. 2014. doi:10.1016/j.ejphar.2014.07.018.
4. Liu B, Fan L, Balakrishna S, Sui A, Moris
JB, Jordt S-E. TRPM8 is the Principal Mediator of Menthol-induced Analgesia of
Acute and Inflammatory Pain. Pain. 2013;154(10):2169-2177.
doi:10.1016/j.pain.2013.06.043.TRPM8.
5. Juergens U, Stober M, Vetter H. The
anti-inflammatory activity of L-menthol compared to mint oil in human monocytes
in vitro: a novel perspective for its therapeutic use in inflammatory diseases.
Eur J Med Res. 1998;3(12):539-545.
6. Alhaider A, Al-Mofleh I, Mossa J,
Al-Sohaibani M, Rafatullah S, Qureshi S. Effect of Carum carvi on
experimentally induced gastric mucosal damage in Wistar albino rats. Int J
Pharmacol. 2006;2(3):309-315.
7. Micklefield G, Jung O, Greving I, May B.
Effects of intraduodenal application of peppermint oil (WS 1340) and caraway
oil (WS 1520) on gastroduodenal motility in healthy volunteers. Phyther Res.
2003;17:135-140. doi:10.1002/ptr.1089.
8. May B, Köhler S, Schneider B. Efficacy
and tolerability of a fixed combination of peppermint oil and caraway oil in
patients suffering from functional dyspepsia. Aliment Pharmacol Ther.
2000;14:1671-1677. doi:10.1046/j.1365-2036.2000.00873.x.
9. Rich G, Shah A, Koloski N, et al. A
randomized placebo-controlled trial on the effects of Menthacarin, a
proprietary peppermint- and caraway-oil-preparation, on symptoms and quality of
life in patients with functional dyspepsia. Neurogastroenterol Motil.
2017;29(May):e13132. doi:10.1111/nmo.13132.
10. Madisch A, Heydenreich C, Wieland V,
Hufnagel R, Hotz J. Treatment of Functional Dyspepsia with a Fixed Peppermint
Oil and Caraway Oil Combination Preparation as Compared to Cisapride – A
multicenter, reference-controlled double-blind equivalence study. Arzneimittelforsch
Drug Res. 1999;49(II):925-932.
This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. This information should not be used for diagnosing a health problem or disease. While medical foods do not require prior approval by the FDA for marketing, they must comply with regulations. It should not be assumed that medical foods are alternatives for FDA-approved drugs. Only doctors can definitively diagnose functional dyspepsia. Use under medical supervision. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.fdgard.com. Individual results may vary.
Other related articles were published in this Open Access Online Scientific Journal include the following:
2012pharmaceutical
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