President signs “Right to Try Act” – “Despite good intentions – right to try legislation grants no rights.”

Perhaps read this first
“Should the terminally ill have the RIGHT-TO-TRY non-FDA approved therapies?”
Highlight and click on

“President Donald Trump signed the “Right to Try Act” Wednesday, a measure aimed at helping terminally ill patients access drug treatments that are yet to be fully approved by the Food and Drug Administration.
Trump, at a White House ceremony surrounded by patients and families who will be affected by the legislation, said his administration “worked hard on this” but said repeatedly he didn’t understand why it hadn’t been done before.
The bill will give terminally ill patients the right to seek drug treatments that remain in clinical trials and “have passed Phase 1 of the Food and Drug Administration’s approval process” but have not been fully approved by the FDA. Some opponents of the bill argue that the legislation won’t change much but could have a detrimental effect on how the FDA safeguards public health.
“With the passage of this bill, Americans will be able to seek cures,” Trump said adding they will finally be given “the right to try.” (A)

“Opponents of the law say Trump’s promises to help thousands or even hundreds of thousands are grossly unrealistic. It isn’t clear that any patients have successfully utilized the dozens of state laws that attempt to give patients a similar pathway for expanded treatments…
Supporters say the new law gives dying patients an important reprieve from overly cumbersome FDA rules, and from what they call a slow-moving bureaucracy that can delay access to time-sensitive treatments.
Opponents have cautioned that the legislation will undermine FDA’s authority and open vulnerable, desperate patients up to “snake oil salesmen.” They point out, too, that the FDA already has a process in place for approving such requests and grants some 99 percent of them, often within a short time frame…
In a statement, Gottlieb said the agency stands ready to implement the new law “in a way that seeks to protect [patients’] autonomy, their safety, and the safety of others following in their paths.” (B)

“Despite good intentions – and the legislation’s name – right to try legislation grants no rights. It would merely grant permission for a patient to try to get experimental medication from a pharmaceutical company.
Patients would be allowed to try experimental drugs, but nothing in the legislation would make it mandatory for pharmaceutical companies to provide these medications.
The reasons for a company to withhold a drug are many. Giving access to preapproval drugs can be costly, particularly given the limited supply, and almost no medical insurance will cover experimental treatments. Access to the drugs will likely only be feasible for wealthy Americans who can afford to pay for the treatment, as well as the consequences of any negative side effects out of pocket.
Many drug companies also worry that making the drug available without approval opens them up to lawsuits if the drugs prove ineffective or have unforeseen side effects. The current federal right to try proposal does provide some protections for companies in this regard, but until those protections have been tested in court, it is likely companies will remain cautious.
Providing the drug to patients outside of clinical trials can also be disruptive to the approval process because it can lead to data on negative clinical outcomes outside the highly controlled trial setting…” (C)

“Opponents also argue it gives “false hope” to patients, since drugmakers aren’t required to give unapproved medicines to patients who ask for them.
Supporters say, however, it will provide new treatment opportunities for terminally ill patients who have exhausted existing options.
“While a long time coming, today is a monumental win for patients desperately seeking the ‘right to try’ investigational treatments and therapies,” said Energy and Commerce Committee Chariman Greg Walden (R-Ore.) and health subcommittee chairman Michael Burgess (R-Texas).
“With ‘right to try’ being the law of the land, we are confident that the Trump Administration, and FDA Commissioner [Scott] Gottlieb, will take both congressional intent and the safety of patients into consideration when implementing this important law.” (D)

“It allows certain patients to ask drugmakers for medicines that have passed Phase 1 of the FDA approval process but haven’t been approved yet and are still undergoing testing. Patients must have exhausted other options and be unable to participate in a clinical trial. Drugmakers aren’t obligated to give patients the requested experimental medicines.
Critics say the legislation undermines the FDA’s authority to regulate drugs and could leave patients vulnerable to medicines that might not work or may even be harmful. The agency already runs an “expanded access” program where seriously ill patients can apply to gain access to experimental treatments.
Commissioner Scott Gottlieb has said the agency grants 99 percent of these requests. In a statement Wednesday, Gottlieb said the FDA is ready to implement the “right-to-try” legislation.
“The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines,” he said.” (E)

““The Administration believes that treatment decisions for those facing terminal illnesses are best made by the patients with the support and guidance of their treating physicians,” the White House said in its statement of support Monday.
Opponents, meanwhile, say the legislation will allow “snake oil salesmen” to take advantage of desperate patients and could ultimately weaken or undermine the FDA’s authority to regulate drugs. They point out, too, that the FDA already has a system in place for granting terminally ill patients access to experimental therapies, often within a tight timeframe. Though opponents said the more refined version of the legislation was an improvement, they said it still failed to address many of their concerns.
“The legislation would roll back essential patient safeguards and could result in patients being harmed by unproven, and potentially unsafe, therapies,” a coalition of patient groups, including the American Cancer Society Cancer Action Network, Friends of Cancer Research, and the National Organization for Rare Disorders, wrote in a letter to lawmakers.. “Furthermore, the legislation would significantly restrict FDA’s ability to stop access to an experimental therapy and would remove expert consulting requirements on dosing and other important safety measures currently provided by FDA.”” (F)

“The president said the issue was “very personal” for him.
“As I proudly sign this bill, thousands of terminally ill Americans will have the help, the hope and the fighting chance — and I think it’s going to be better than chance — that they will be cured, that they will be helped, that they will be able to be with their families for a long time, or maybe just for a longer time,” Trump said. “But we’re able to give them the absolute best we have at this current moment, at this current second. We’re going to help a lot of people. It’s an honor to be signing this.” “ (G)

“A program known as compassionate use, or expanded access, has been in place since the 1970s. It allows patients with a serious disease or condition to obtain experimental medicines; the Food and Drug Administration says it authorizes 99 percent of the requests for expanded access that it receives.
The new national law — like similar laws in more than three dozen states — allows patients and doctors to ask drug companies directly for access to the experimental drugs, rather than wait for approval by the agency.
Yet these laws “do not ensure that manufacturers will provide the drug or that insurance companies will cover the cost,” according to a policy report from Rice University. Obtaining the medicines from manufacturers can be more cumbersome than going through the Food and Drug Administration’s existing program, the report found.
Colorado enacted the first right-to-try law in 2014. Since then, “there have been no documented cases of anyone receiving access, because of a right-to-try law, to an experimental product that would not have been available via the F.D.A.’s expanded access program,” a 2017 study by researchers from New York University concluded.
Alison Bateman-House, a professor of medical ethics and an author of the study, called it “extremely unlikely” that the national right-to-try law would directly save hundreds of thousands of lives, given that drug companies are using — and accustomed to — the existing process.” (H)

“Most experimental drugs are nowhere close to being effective, or carry side effects outweighing their benefits. But if they were, who could afford to try them?
“The law gives the right to pay, not the right to try,” says Arthur Caplan, head of medical ethics at New York University’s School of Medicine, who also studies compassionate access to medication. The law, he explains, doesn’t come with a budget, leaving patients paying out-of-pocket for unproven treatments. Insurance companies are unlikely to help out; they’re not even required to cover all the drugs that are approved by the FDA.
Medical costs are already the leading cause of bankruptcy in the US. Under “right to try,” a cancer patient could end up paying additional hundreds of thousands of dollars for experimental treatment, on top of their existing costs. False hope could tempt sick Americans to poor financial decisions, argues Caplan. “You are asking terminally ill people to spend their family’s savings on drugs that don’t work,” he says.” (I)

“Today, 40 states have passed similar laws. And on Wednesday, President Trump will sign a national Right to Try Act into law. In the states, Right to Try has not been a partisan issue. In most instances, it passed without a single dissenting vote…
But, sadly, this spirit of bipartisanship did not translate to Washington. Only 22 House Democrats voted for the final bill that Trump will sign. In August, a version introduced by Sen. Ron Johnson, R-Wis., passed the Senate by unanimous consent, but stalled in the House, which eventually passed a more limited bill from Rep. Greg Walden, R-Ore. Last week, Senate Republicans tried to accommodate Democratic objections by bringing up the Walden bill for a vote, but Senate Minority Leader Charles Schumer blocked it from coming to the floor. So the House passed the Johnson version, with Democrats nearly united in opposition.
In other words, Democrats in Washington managed to take an issue that unified thousands of legislators from both parties in 40 states, and turned it into a divisive, party-line vote. Thanks to Trump, Americans facing terminal diagnoses will now have a new chance at life. How tragic — and pathetic — that Democrats refused to join him in making that happen.” (J)

“From now on, these patients — in fact, practically anyone who has been diagnosed with any life-threatening disease or condition, whether or not he or she is near death — will be able to choose to trust doctors and drug companies alone to look out for their well-being…
Under the new law, without the FDA’s expert guidance, companies will have even more reason to turn down requests for experimental medicines. Those inclined to provide the drugs, if they’re wise, will continue to do so only through the FDA’s existing channel — as Janssen Pharmaceuticals has decided to do. The company says that the FDA may be “uniquely aware” of available safety data.
FDA Commissioner Scott Gottlieb has pledged to carry out the new law in a way that promotes access and protects patients. But he has no authority to do anything except issue guidance and receive annual summaries from companies providing investigational drugs.
A word of advice to doctors and patients who choose to sidestep the FDA: Proceed with care, and don’t count on a miracle.” (K)

(A) Trump signs ‘Right to Try Act’ aimed at helping terminally ill patients seek drug treatments, by Allie Malloy, https://www.cnn.com/2018/05/30/politics/right-to-try-donald-trump/index.html
(B) Trump signs right-to-try legislation, making controversial measure law of the land, by ERIN MERSHON, https://www.statnews.com/2018/05/30/trump-signs-right-to-try/
(C) What is “right to try” and will it help terminally ill patients? by Morten Wendelbo, Timothy Callaghan, https://www.cbsnews.com/news/right-to-try-bill-trump-signing-will-it-help-terminally-ill-patients-today-2018-05-30/
(D) Trump signs ‘right to try’ drug bill, by Jessie Hellmann, http://thehill.com/policy/healthcare/389908-trump-signs-right-to-try-bill-for-terminally-ill-patients
(E) President Trump signs ‘right-to-try’ bill for experimental drugs, by Angelica LaVito,| https://www.cnbc.com/2018/05/30/trump-signs-right-to-try-legislation-on-experimental-medicines.html
(F) Congress passes ‘right-to-try’ measure, sending hard-fought bill to Trump’s desk, https://www.statnews.com/2018/05/22/house-vote-right-to-try/?utm_source=STAT+Newsletters&utm_campaign=cdfd050a18-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-cdfd050a18-149527969
(G) Trump signs ‘Right to Try,’ says it will save ‘tremendous number of lives’, by Brooke Singman, http://www.foxnews.com/politics/2018/05/30/trump-signs-right-to-try-says-it-will-save-tremendous-number-lives.html
(H) Trump Oversells New ‘Right to Try’ Law, by Linda Qiu, https://www.nytimes.com/2018/05/30/us/politics/fact-check-trump-right-to-try-law-.html
(I) Who pays for the “right to try” experimental medicine?, by Annalisa Merelli, https://qz.com/1292947/under-the-right-to-try-act-who-pays-probably-not-insurance/
(J) Thiessen: Terminally ill thank GOP for ‘Right to Try’, by MARC A. THIESSEN, https://www.mercurynews.com/2018/05/30/thiessen-terminally-ill-can-thank-republicans-for-right-to-try-investigational-drugs/
(K) A ‘Right to Try’ That Americans Didn’t Need, https://www.bloomberg.com/view/articles/2018-05-31/a-right-to-try-that-americans-didn-t-need

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“Raw” Curated Contemporaneous Health Care Case Study Methodology by Jonathan M. Metsch, Dr.P.H.

I taught full time in the Baruch MBA in Health Care Administration program from 1972 to 1975, then was a health care administrator for over thirty years, finishing for seventeen years as President & CEO of LibertyHealth/ Jersey City Medical Center, where we built a replacement safety-net hospital (it took 15 years), played a key role on September 11th, 2001, and once again became a medical school affiliated teaching hospital (having been free-standing for decades).
After retiring from LibertyHealth, I returned to the Baruch program for four years as Adjunct Professor and started writing case studies. I developed case studies based on my CEO experiences. Interestingly case studies on failures provided better Lessons Learned than cases on successes. I also used Harvard Case Studies, and invited “Visiting” Professors to present cases typically related to the new realities of Obamacare, mostly C-Level executives I was still in touch with from my first stint at Baruch. I was very proud of what they had accomplished and shared.
In retirement I have watched health care disruption become so complex that there are few, if any, up-to-date case studies. So I developed a method of “raw” contemporaneous cases studies each developed by curating news articles into a coherent thread, after a topic has called out to me. Topics come from navigating the system (think out-of-network physicians, for example), news feeds, and friends and family.
Now, my Career Capstone Project is to bring “raw” cases to AUPHA that can be used in real-time, meaning they can start a discussion for immediate use in class. For example if I was teaching now I would be doing a contemporaneous cases on the opioid crisis, tracking the implications of medicinal/ recreational marijuana, and the stealth plan to reintroduce Trumpcare before Congress adjourns for the mid-term election.

Here’s my way of developing a case:

A. Spend some time looking at the case format at http://doctordidyouwashyourhands.com/

B. To identify CCCS topics sign-up for daily automatic health care news feeds. For example:
1. STAT https://www.statnews.com/
2. MedPageToday https://www.medpagetoday.com/
3. Becker’s Hospital Review https://www.beckershospitalreview.com/
4. Healthcare Dive https://www.healthcaredive.com/
5. FierceHealthcare https://www.fiercehealthcare.com/
6. New York Times
7. Hospital Association Daily News Clips

C. Set up Google Alerts https://www.google.com/alerts https://support.google.com/websearch/answer/4815696?hl=en (for example: Amazon. health care; medical/ recreational marijuana; cost of prescription/ generic drugs; Ebola; Emerging viruses; flu; health care disruption; health care innovation; health insurance; hospital innovation;.; ObamaCare; opioid crisis; Trump Care; Zika)

D. Select topics to follow and make a folder for each (for example: Amazon+, precision medicine, Zika, marijuana, antibiotics; insurance; flu, hospitals; Obamacare/ TrumpCare; opioid crisis; prescription and generic drugs, right-to-try)

E. Then every day from News Feeds select articles on your topics and move them to the appropriate folder.

F. When you are inspired to write a “case” start a Word document, then go to the case folder and select key points from the articles, and cut and paste them to the Word document. As well capture article title, author and hyperlink.

G. Move the key points around until you have created a story.

H. Then label each point A,B.C…and move article title, author and hyperlink to footnotes at the end of the case.

I. Then write an introduction to the case.

Jonathan M. Metsch, Dr.P.H.
http://www.mountsinai.org/profiles/jonathan-m-metsch

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As ZIKA and EBOLA reemerge, Trump administration cuts funding to halt international epidemics

March 13th
“The White House appeared to declare victory this week for an Obama-era initiative to stamp out disease outbreaks around the world even as it moved to scale back the program…,
But the United States is set to dramatically shrink its contributions to the initiative, a point that the report omitted. The Centers for Disease Control and Prevention is preparing to narrow epidemic work from 49 countries to 10, an agency spokeswoman said.
That has alarmed health policy experts.
“It’s not a matter of if — but when — there will be another Ebola or Zika, and right now, the world isn’t ready,” said Dr. Thomas R. Frieden, who led the C.D.C. during the West African Ebola outbreak. “Many life-threatening gaps have been identified, but most of them haven’t been closed.” “ (A)

“The response to the Zika virus is fairly typical of both our strengths and weaknesses in dealing with infectious diseases, especially when they emerge. Existing drugs against other viruses were identified as potential therapeutics for Zika, efforts to develop a vaccine are underway and nearing completion, and the concern about Zika spurred some needed and valuable research. Those are encouraging signs, but these efforts were somewhat slow to get started and preceded by the usual complacency. We tend to close the barn door only after most of the horses have escaped.” (B)

May 8th
“The Government of the Democratic Republic of the Congo declared a new outbreak of Ebola virus disease (EVD) in Bikoro in Equateur Province today (8 May). The outbreak declaration occurred after laboratory results confirmed two cases of EVD.
The Ministry of Health of Democratic of the Congo (DRC) informed WHO that two out of five samples collected from five patients tested positive for EVD at the Institut National de Recherche Biomédicale (INRB) in Kinshasa. More specimens are being collected for testing.
WHO is working closely with the Government of the DRC to rapidly scale up its operations and mobilize health partners using the model of a successful response to a similar EVD outbreak in 2017.
“Our top priority is to get to Bikoro to work alongside the Government of the Democratic Republic of the Congo and partners to reduce the loss of life and suffering related to this new Ebola virus disease outbreak,” said Dr Peter Salama, WHO Deputy Director-General, Emergency Preparedness and Response. “Working with partners and responding early and in a coordinated way will be vital to containing this deadly disease.” “ (C)

May 17th
“An Ebola outbreak in the Democratic Republic of Congo has spread to a major city — Mbandaka, with a population of about 1 million people — officials said.
The country’s health minister said authorities are intensifying work to identify those who have been in contact with suspected cases. Another concern is the disease could be spread through commerce, as the city is a major trade thoroughfare on the banks of the Congo River.” (D)

May 17th
National Institutes of Health officials assured lawmakers on Thursday that U.S. health experts are following concerns of an Ebola outbreak in Africa closely and said a number of medical countermeasures have already been deployed in response.
“Obviously given our prior experience, we are on very high alert,” said Anthony Fauci, M.D., head of the National Institute of Allergy and Infectious Diseases, in response to a question about how worried the U.S. should be about reports that Ebola had been found in an urban area of the Democratic Republic of Congo….
…at least one case is now in a more populated area, he said: “Even though there is only one case there, there’s a total now of 44 cases, even though only two have been confirmed. There are 20 that are probable and 20 that are suspicious. So there are probably many more cases.”…
“We are on high alert. We are always concerned when there is Ebola. But we right now have a number of countermeasures that we were able to develop to go in and hopefully block that,” he said. “Our expectations are always cautious. Our hopes are always that we will not have the kind of outbreak that we saw in West Africa.” (E)

May 18th
“Congo at ‘Very High’ Risk as Ebola Strikes Major City. WHO raises the public-health risk to ‘very high,’ as the deadly virus reaches a large port city
Aid organizations and the Congolese government rushed supplies and health experts Friday to a major city in the Democratic Republic of Congo, after the World Health Organization raised the public-health risk from the latest Ebola outbreak to “very high.”
Congo’s threat from the deadly disease was elevated from high by the WHO, who also upped the risk to neighboring nations to high from moderate. Very high is the second-highest risk level available, below serious.” (F)

May 18th
“What’s the worse-case Ebola outbreak?
Public health officials would say it’s when the virus is spreading in a crowded urban environment that’s a major transportation hub and has dilapidated, ill-equipped health care facilities.
Unfortunately, that’s what’s happening right now in the northwest of the Democratic Republic of the Congo…
That’s why the World Health Organization along with Congolese officials and other aid agencies are scrambling to try to contain this outbreak before it grows much larger…
Congolese health officials now say there have been 45 suspected cases reported in their country since April. And 25 people have died. Laboratory testing of patient blood samples, however, has been progressing slowly; 14 of the cases have been confirmed as Ebola.
Four thousand doses of an experimental Ebola vaccine — which has to be stored at minus 60 degrees Celsius — have shipped to the DRC. Plans are being developed to try to vaccinate hundreds if not thousands in areas near where Ebola cases have been found.
Doctors Without Borders is setting up isolation wards and Ebola treatment centers both near the epicenter of the outbreak and in the port city of Mbandaka.
The Red Cross is recruiting local volunteers to collect and safely bury the dead.
“We have now 20 volunteers trained on how to do these burials,” says Karsten Voigt, operations manager for the International Federation of the Red Cross in the Democratic Republic of the Congo.” (G)

May 18th
“The Ebola outbreak in Democratic Republic of Congo can be brought under control and is not an international public health emergency, experts advising the World Health Organization said on Friday.
Earlier in the day the WHO had said the first confirmation of Ebola in Mbandaka, a city of about 1.5 million people, had prompted it to declare a “very high” public health risk to the country and a “high” risk to the region.
But the WHO’s Emergency Committee of 11 experts said the rapid response had mitigated the risk from the outbreak, which was declared 10 days ago and has killed 25 people since early April.
“Interventions underway provide strong reason to believe that the outbreak can be brought under control,” the committee said in a statement.
They decided not to declare a “public health emergency of international concern” (PHEIC), a formal alert that puts governments on notice and helps mobilise resources and research.
However, committee chairman Robert Steffen said the “vigorous” outbreak response must continue.” (H)

May 19, 2018
“ Three new cases of the often lethal Ebola virus have been confirmed in a city of more than one million people, Congo’s health minister announced, as the spread of the hemorrhagic fever in an urban area raised alarm.
The statement late on Friday said the confirmed cases are in Mbandaka, a city where a single case was confirmed earlier in the week.
There are now 17 confirmed Ebola cases in this outbreak, including one death, plus 21 probable cases and five suspected ones…
While Congo has contained several Ebola outbreaks in the past, all of them were based in remote rural areas. The virus has twice made it to Congo’s capital of 10 million people, Kinshasa, in the past but was rapidly stopped.
Health officials are trying to track down more than 500 people who have been in contact with those feared infected, a task that became more urgent with the spread to Mbandaka, which lies on the Congo River, a busy traffic corridor, and is an hour’s flight from the capital.” (I)

May 19th
“The U.S. government is preparing its most direct response yet to the outbreak that appears to have begun in April, readying staffers from the Centers for Disease Control and Prevention (CDC) to deploy to multiple communities in the Democratic Republic of Congo…
The present outbreak has raised anew questions about WHO and its capacity to respond to deadly viral threats. In the wake of the West African outbreak ago, when the ill-prepared WHO endured withering criticism for its lackluster response to the initial round of cases, the agency has undergone a remarkable round of self-flagellation, reorganizing to prioritize emergency preparedness and response while cutting bureaucracy.” (J)

“Regular vaccines can be tested in a few different ways. In one approach, researchers can vaccinate people and then expose them to the pathogen that the vaccine targets. That was never an option for a virus as deadly as Ebola.
Another approach is the standard randomized clinical trial. Enroll a large number of volunteers who may encounter the pathogen in their day-to-day life, and randomly assign some to be vaccinated. If researchers see more illness in the people who didn’t get the vaccine, it is considered to offer protection.
But a standard randomized clinical trial doesn’t work when a pathogen circulates as rarely as Ebola does. In the 42 years since the first known Ebola outbreak, only about 31,000 people are known to have been infected — and most of those infections occurred in the West African outbreak of 2013-2016. Outbreaks have ranged over a terrain that spans thousands of miles from West Africa to Central Africa.
Researchers could vaccinate thousands of people and follow them for years without seeing any disease in either the vaccine recipients or the control group.
Even testing during an outbreak was traditionally thought to be impossible. But the West African outbreak changed that thinking.
The vaccine now being fielded in the DRC — the VSV vaccine — was shown to be effective in Guinea in a so-called ring vaccination trial, in which people exposed to a case were vaccinated in an attempt to build a wall of immunity that cuts off the virus’s ability to spread.
In the latest outbreak, if the vaccine works as well as earlier studies suggest, it could present a paradigm shift in the way the world thinks about Ebola outbreaks.” (K)

May 24th
Two infected patients who fled from an Ebola treatment center in a Congo city of 1.2 million people later died, an aid group said Wednesday while asserting that “forced hospitalization is not the solution to this epidemic.”
As the number of suspected Ebola cases continued to rise, experts emphasized that more community engagement is needed to prevent the spread of the deadly virus.
Three patients left of their own accord from the isolation zone of the Wangata hospital in Mbandaka city between Sunday and Tuesday, said Henry Gray, emergency coordinator for Medecins Sans Frontieres.
One patient had been about to be discharged, he said. “The two others were helped to leave the hospital by their families in the middle of the night on Monday. One of the men died at home and his body was brought back to the hospital for safe burial with the help of the MSF teams; the other was brought back to the hospital yesterday morning and he died during the night,” Gray said in a statement.” (L)

May 24th
“Congo’s fight to rein in a deadly Ebola outbreak has authorities crossing the border to buy up available thermometers, a World Health Organization official said, as the health ministry on Thursday announced that confirmed cases had reached 30, including eight deaths.
The spread of the often lethal hemorrhagic fever to a provincial capital of 1.2 million people has health officials scrambling to monitor for Ebola at busy ports in the capital, Kinshasa, which is downstream from the infected city of Mbandaka on the Congo River…
In Kinshasa, travelers streamed off boats at ports on the Congo River and ran a gauntlet of health officials watching for signs of infection.
“We want to ensure that ports and airports are effectively protected,” WHO’s Congo representative Allarangar Yakouide told The Associated Press. “I assure you, we have already taken all the thermometers that are in Kinshasa, practically all the thermometers, and there are even colleagues who are going on the other side to Brazzaville to buy thermometers.”
The Republic of Congo’s capital is across the river from Kinshasa, a city of 10 million.” (M)

““A lot of what’s working now is the result of remembering and learning from previous failures,” said Jeremy Konyndyk, a senior policy fellow at the Center for Global Development and the director of foreign disaster assistance at the United States Agency for International Development during the Obama administration.
The Trump White House, however, appears to be uniquely amnesiac. On the same day that officials in the Democratic Republic of Congo reported the new Ebola cases, the administration sought to rescind $252 million in Ebola response funds left over from the earlier epidemic.
Before Congress acts on that request, members should recall how those funds came to be. Public health officials confirmed the 2014 outbreak at the end of a fiscal year, when most agency budgets — at the Centers for Disease Control and Prevention, U.S.A.I.D. and elsewhere — were tapped out. The search for additional funding delayed the American response, which in turn led to more lives lost and, ultimately, more money spent. To prevent the same thing from happening next time, the White House Office of Management and Budget agreed to leave these funds in U.S.A.I.D.’s budget so they would be on hand to combat the next emergency. Rescinding that money brings us back to where we started — ill prepared to mount a rapid response to a new infectious disease threat.
Around the same time that the administration proposed rescinding the funds, the National Security Council dissolved its biosecurity directorate, a small team focused exclusively on global health security threats and led by a director often referred to as the Ebola czar…
The Trump administration has also failed to seek renewed funding from Congress for a global health security initiative begun after the 2014 epidemic…
But whether and how these policy shifts will affect the current Ebola response remains to be seen. Though the outbreak seems to have been quickly contained, it involves a disease that we have fresh and terrifying experience with, in a country that has seen this particular foe nine times in living memory. The next outbreak may not offer such a head start. And when it comes, Mr. Trump’s shortsightedness, if it is not corrected, will have left us far less prepared.” (N)

(A) White House Hails Success of Disease-Fighting Program, and Plans Deep Cuts, by Emily Baumgaertner, https://www.nytimes.com/2018/03/13/us/politics/trump-ebola-disease-cuts-global-health-security-agenda.html
(B) Cannot be complacent, by Stephen S. Morse, https://www.theweek.in/health/more/2018/05/05/cannot-be-complacent.html
(C) New Ebola outbreak declared in Democratic Republic of the Congo, http://www.who.int/news-room/detail/08-05-2018-new-ebola-outbreak-declared-in-democratic-republic-of-the-congo#.WvMD0bhGhfE.email
(D) WHO mulling health emergency over Congo Ebola outbreak, by Susan McFarland, https://www.upi.com/Top_News/World-News/2018/05/17/WHO-mulling-health-emergency-over-Congo-Ebola-outbreak/1061526551624/
(E) NIH officials on ‘high alert,’ deploying countermeasures in response to Ebola outbreak, https://www.fiercehealthcare.com/hospitals-health-systems/nih-countermeasures-deployed-hopes-not-to-see-repeat-ebola-outbreak?
(F) Congo at ‘Very High’ Risk as Ebola Strikes Major City, by Nicholas Bariyo, https://www.wsj.com/articles/congo-at-very-high-risk-as-ebola-strikes-major-city-1526640110
(G) Ebola Outbreak: How Worried Should We Be?, by Jason Beaubien, https://www.npr.org/sections/goatsandsoda/2018/05/18/612010495/ebola-outbreak-how-worried-should-we-be
(H) Congo’s Ebola not an international emergency, can be controlled –WHO, by Tom Miles and Fiston Mahamba, https://www.reuters.com/article/us-health-ebola/ebola-congo-outbreak-high-risk-but-can-be-brought-under-control-who-idUSKCN1IJ0CM
(I) Congo says 3 new Ebola cases confirmed in large city,https://www.srnnews.com/congo-says-3-new-ebola-cases-confirmed-in-large-city/
(J) The Ebola superhighway: Why the new outbreak terrifies public health authorities, by Reid Wilson, http://thehill.com/policy/healthcare/388401-the-ebola-superhighway-why-a-new-outbreak-terrifies-public-health
(K) ‘You’re holding your breath’: Scientists who toiled for years on an Ebola vaccine see the first one put to the test, by HELEN BRANSWELL, https://www.statnews.com/2018/05/22/ebola-scientists-outbreak/
(L) Ebola response on ‘knife’s edge’ as timing key, WHO says, https://abcnews.go.com/Health/wireStory/nations-mobilize-prevent-ebola-spread-55374170
(M) Congo says confirmed Ebola cases have reached 30; 8 deaths; by Saleh Mwanamilongo, https://www.washingtonpost.com/world/africa/congo-says-ebola-cases-have-reached-30-warns-against-rumors/2018/05/24/88404b66-5f32-11e8-b656-236c6214ef01_story.html?noredirect=on&utm_term=.cbc0505f0c13
(N) Ebola, Amnesia and Donald Trump, https://www.nytimes.com/2018/05/22/opinion/ebola-outbreak-trump.html

May 3rd
“we are not finished with Zika… It very well could come back.” Are we ready?
highlight and click on

_____________
CURATED CHRONOLOGY OF 2016/ 2017 ZIKA CONUNDRUM & 2018 FLU EPIDEMIC

June 6, 2016
Former hospital prez says: Designate local Zika centers now. Medical experts do not know if, or where, or how much, or on what trajectory the Zika virus may spread across the United States.

August 13, 2016
The ER clerk asked me “How do you spell Zika?

August 19, 2016
With little gudiance about caring for Zika patients, hospitals are planning on their own

September 7, 2016
Hospitals are developing their own Zika preparedness models. Compare the Central Florida and Johns Hopkins approaches! Which template makes more sense?

September 29, 2016
All pregnant women with Zika diagnosed at community hospitals must be referred to academic medical centers for prenatal care!

May 15, 2017
EBOLA is back in Africa. Is ZIKA next? Are we prepared?

June 10, 2017
Study Findings: Five percent of pregnant women with a confirmed Zika infection.. went on to have a baby with a related birth defect

June 21, 2017
When I was a kid the only thing as scary as the polio epidemic was practicing getting under our desks for a nuclear attack…

July 18, 2017
In June WEST NILE was identified nationwide. Today it’s POWASSAN VIRUS. – ARE WE PREPARED FOR A SURGE OF EMERGING MOSQUITO AND TICK BORNE VIRUSES?

July 20, 2017
“Houston Braces for Another Brush With the Peril of Zika” *. But they are doing passive not active surveillance. IS YOU AREA’S HEALTH CARE SYSTEM PREPARED FOR A SURGE OF AN EMERGING VIRUS LIKE ZIKA?

July 27, 2017
Locally transmitted ZIKA case in Texas! Are we ready?

October 11, 2017
CDC deactivated its emergency response center for Zika.. The first probable locally acquired Zika case in 2017 has been confirmed in Texas….

November 7, 2017
a hand held device (was used) to measure the germ-count on some of New York City’s dirtiest surfaces

January 8, 2018
“We are arguably as vulnerable—or more vulnerable—to another (flu) pandemic as we were in 1918.”

January 11, 2018
In the ICU at Massachusetts General Hospital, nurses use Gatorade to combat flu-related dehydration (due to shortages of intravenous fluids)

January 15, 2018
The CDC postponed its briefing on preparation for nuclear war and will focus on responding to severe influenza

January 17, 2018
“Think hospitals are under a strain now, from a slightly bad flu season? Wait until a really bad one hits.”

January 20, 2018
Government Shutdown. “The CDC would furlough key staff amid one of the most severe flu seasons in recent memory….”

January 23, 2018
“..in a severe (flu) pandemic, the U.S. healthcare system could be overwhelmed in just weeks.

updated May 24th

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New Ebola outbreak declared in Democratic Republic of the Congo

On May 3rd we posted:
“we are not finished with Zika… It very well could come back.” Are we ready?

Today:
The Government of the Democratic Republic of the Congo declared a new outbreak of Ebola virus disease (EVD) in Bikoro in Equateur Province today (8 May). The outbreak declaration occurred after laboratory results confirmed two cases of EVD.
The Ministry of Health of Democratic of the Congo (DRC) informed WHO that two out of five samples collected from five patients tested positive for EVD at the Institut National de Recherche Biomédicale (INRB) in Kinshasa. More specimens are being collected for testing.
WHO is working closely with the Government of the DRC to rapidly scale up its operations and mobilize health partners using the model of a successful response to a similar EVD outbreak in 2017.
“Our top priority is to get to Bikoro to work alongside the Government of the Democratic Republic of the Congo and partners to reduce the loss of life and suffering related to this new Ebola virus disease outbreak,” said Dr Peter Salama, WHO Deputy Director-General, Emergency Preparedness and Response. “Working with partners and responding early and in a coordinated way will be vital to containing this deadly disease.”

(A) http://www.who.int/news-room/detail/08-05-2018-new-ebola-outbreak-declared-in-democratic-republic-of-the-congo#.WvMD0bhGhfE.email

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“we are not finished with Zika… It very well could come back.” Are we ready?

In 2014, I suggested several anchor principles for Ebola preparedness in New Jersey, as hospitals of all sizes and scope “marketed” their Ebola readiness, only to learn that it took well over 20/ 25 full time staff to care for one Ebola patient (and 50 in Dallas!).
These recommendations included that every hospital that certified its Emergency Room as ready for Ebola be subject to at least three separate drills using a standardized form, and then be subject to random “secret shopper” inspections; that anyone with a confirmed or suspected Ebola diagnosis be immediately transferred to a regional center hospital designated by national standardized criteria which could demonstrate that it has sufficient nursing staff “volunteers” to care for a least five patients round the clock; and that isolation hospitals be readied for instant activation, whether a closed hospital prepared for Ebola now and standing by, or a “virtual” hospital ready-to-go in military fashion.
Also there was a need to minimize Ebola patients walking into an ER unannounced, and suggested a statewide 800 number be established so patients can call ahead and be transported by a prepared ambulance team and taken to a regional center.
The Federal government, later than sooner, did exclusively designate three national bio containment facilities hospitals as Ebola Centers.
In 2016 I suggested that similar organizing principles were urgently need to be established for tiered Zika hospital preparedness by designating Zika Regional Referral Centers. More specifically:
1. There should not be an automatic default to just designating Ebola Centers as ZRRCs, although there is likely to be significant overlap.
2. Zika Centers should be academic medical centers with respected, comprehensive infectious disease diagnostic/ treatment and research capabilities, and rigorous infection control programs. They should also offer robust, comprehensive perinatology, neonatology, and pediatric neurology services, with the most sophisticated imaging capabilities (and Zika-related “reading” expertise).
3. National leadership in clinical trials.
4. A track record of successful, large scale clinical Rapid Response.
5. Organizational wherewithal to address intensive resource absorption.
6. Start preliminary planning for Zika care out of the initial designated ZRRCs.
Zika protocols will be templates for are other mosquito borne diseases lurking on the horizon, such as Chikungunya, MERS, and Dengue.

Where are we today on readiness for Zika or other emerging viruses?

“Farewell, carefree days of summer. The number of people getting diseases transmitted by mosquito, tick and flea bites has more than tripled in the United States in recent years, federal health officials reported on Tuesday. Since 2004, at least nine such diseases have been discovered or newly introduced here…
New tickborne diseases like Heartland virus are showing up in the continental United States, even as cases of Lyme disease and other established infections are growing. On island territories like Puerto Rico, the threat is mosquitoes carrying viruses like dengue and Zika…
Between 2004 and 2016, about 643,000 cases of 16 insect-borne illnesses were reported to the C.D.C. — 27,000 a year in 2004, rising to 96,000 by 2016. (The year 2004 was chosen as a baseline because the agency began requiring more detailed reporting then.).. (A)

Mosquito-borne disease epidemics happen more frequently.
Chikungunya and Zika viruses caused outbreaks in the US for the first time.
Seven new tickborne germs can infect people in the US…
The US is not fully prepared
Local and state health departments and vector control organizations face increasing demands to respond to these threats.
More than 80% of vector control organizations report needing improvement in 1 or more of 5 core competencies, such as testing for pesticide resistance.
More proven and publicly accepted mosquito and tick control methods are needed to prevent and control these diseases.” (B)

““Mosquitoes—and the viruses that they carry—are pushing up the incidence of malaria globally and causing periodic explosive outbreaks of Rift Valley fever, which first brings on flulike symptoms but can turn into a severe hemorrhagic fever akin to Ebola. Bluetongue virus, a ruminant virus spread by midges that was once confined to tropical areas, has reached as far as Norway. Studies have shown shifts in cholera transmission with recent climate variability. As emerging diseases migrate to new areas, they encounter new species, making outbreaks even more difficult to manage.
Unfortunately, writes journalist Lois Parshley in her feature article “Catching Fever,” the common enabler for the movement of each of these ailments is human-caused climate change. As weather patterns wreak more havoc, a Pandora’s box of microbes enters new terrain, stressing global public health systems…
Such alterations are happening whether we want to use the words “climate change” or not. Whether we acknowledge the scientific consensus, demonstrated in thousands of studies over decades, climate change is both real and promoted by human activities. Coastal communities are being affected by rising seas, drought-prone areas are arid for longer periods and, as our report shows, infectious agents are taking advantage of these more extreme weather patterns.” (C)

“Texas Department of State Health Services released a report its first two travel related Zika cases in Williamson County this Spring.
DSHS said it serves as a reminder for people to be cautious as they travel this summer.
Austin Public Health got a jump start on mosquito prevention with a tire drive Sunday afternoon. Dozens of people dropped of extra and abandon tires that tend to lay idle and collect water.
Ashley Hawes, APH Research Analyst said when the department surveys communities who attract mosquitoes they realized many had standing water collected by tires, bird baths, and rain gutters.
“If we can educate people of simple ways they can get rid of water in their area they can help reduce mosquitos and hopefully reduce the amount of people who get sick from diseases like West Nile and Zika,” Hawes said…
Hawes said one spoon full of water can attract about 10,000 mosquitoes “ (D)

“Two years ago, the world was gripped in Zika panic as the mosquito-borne virus infected millions and spread across 80 countries. Officials declared a global health emergency and tourists canceled their tropical vacations. Thousands of babies were born with devastating birth defects after their mothers were infected in pregnancy…
Still, “we are not finished with Zika,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “Even though when you look at the number of infections, it’s dramatically down, it doesn’t mean they’re going to stay down,” Fauci said. “You’ve got to be careful when dealing with vector-borne diseases. They have a tendency to cycle in and out. It very well could come back.”…
The U.S. Centers for Disease Control and Prevention recently deactivated its emergency response system for Zika that was launched in January 2016…
The future of Zika could look like the pattern of mosquito-borne West Nile virus, which hit highs 9,862 cases in the U.S. in 2003 and hasn’t reached those numbers since. Or it could be more like dengue virus, with four subtypes that reliably infect more than 1 million people each year in the Southern Hemisphere…
“We can’t totally write it off yet,” Lawrence said. “It’s still a potential problem for people traveling. There is always the potential for changes in the virus. I don’t think the story is over.” “ (E)

“Despite the powerful technologies that scientists currently have to characterize pathogens and treat the infections they cause, the course and consequences of epidemics are still a source of surprise. Modern tools of molecular biology have enabled researchers to tear apart the Zika virus and decipher all of its genes and proteins, to map the antibodies and blood cells it mobilizes in infected individuals. But we still don’t know why some people contract the microbe with little or no illness, at most mild fever and muscle aches, while others suffer Guillain-Barré syndrome, a life-threatening paralysis. And we can’t distinguish between those pregnant women whose babies will be born deformed and others who seem to escape the most devastating neurological effects of the virus…
While the spectre of Zika in the Americas is fading, it’s wise to stay vigilant. Some experts worry that new cases of Zika recently reported in northern Mexico could presage another outbreak, with subsequent spread to U.S. border states. Relying on herd immunity is shortsighted, since over time fewer people will be infected and the virus can gain a new foothold. Indeed, the geographic distribution of Aedes aegypti, the mosquito species that transmits Zika, is expanding. The insect is infesting unexpected parts of North America and Europe; a population of A. aegypti was recently found in Washington, D.C., and appears to have survived four consecutive winters. The steady creep of climate change could bring A. aegypti farther north, where there is no herd immunity.” (F)

“An international consortium of researchers has reported that an Ebola vaccine appears to provide volunteers protection against the virus two years after they were injected — encouraging findings both for the public health community and the vaccine’s manufacturer.
An earlier study, conducted in Guinea near the end of the devastating West African Ebola outbreak, showed the vaccine from Merck, which is given in a single shot, rapidly generated protection against the virus. But how long that protection lasts remained an open question.
A fast-acting, long-lasting vaccine given in a single dose would be an effective tool for controlling dangerous Ebola outbreaks. Vaccinating health care workers, for instance, could prevent the type of spread within hospitals that, in the early days of an outbreak, can turn a smoldering outbreak into a conflagration.” (G)

“Analyses of more than 400 mice in New York City found that they carried previously unknown viruses and antibiotic-resistant bacteria.
Mice that live in the basements of New York City apartment buildings — even at the most exclusive addresses — carry disease-causing bacteria, antibiotic-resistant bugs and viruses that have never been seen before, a new study from Columbia University finds…
The viruses included nine species that had never been seen before and others that have not been known to cause human disease, according to the study, published Tuesday in the journal mBio.
But in a second study focused on bacteria, the researchers detected some of the most recognizable disease-causing pathogens, including Shigella, Salmonella, Clostridium difficile and E. coli. The scientists also found antibiotic-resistant bacteria like those that have become nearly untreatable at area hospitals…
“They are a potential source of human infection,” said Dr. W. Ian Lipkin, the epidemiologist at the Mailman School of Public Health at Columbia who was the senior author on the study. “The real message is that these things are everywhere.”” (H)

“A baby believed to have contracted a drug-resistant strain of typhoid, hospitalized in Hyderabad, Pakistan in February. Nadeem Khawer/European Pressphoto Agency
The first known epidemic of extensively drug-resistant typhoid is spreading through Pakistan, infecting at least 850 people in 14 districts since 2016, according to the National Institute of Health Islamabad.
The typhoid strain, resistant to five types of antibiotics, is expected to disseminate globally, replacing weaker strains where they are endemic. Experts have identified only one remaining oral antibiotic — azithromycin — to combat it; one more genetic mutation could make typhoid untreatable in some areas.
Researchers consider the epidemic an international clarion call for comprehensive prevention efforts. If vaccination campaigns and modern sanitation systems don’t outpace the pathogen, they anticipate a return to the pre-antibiotic era when mortality rates soared.
“This isn’t just about typhoid,” said Dr. Rumina Hasan, a pathology professor at the Aga Khan University in Pakistan. “Antibiotic resistance is a threat to all of modern medicine — and the scary part is, we’re out of options.” “ (I)

“Members of a government ethics panel have renewed their criticisms of a controversial study in which volunteers are to be deliberately infected with the Zika virus.
In an article published this month in the journal Science, panel members called for the establishment of ethics committees to review the design of such human-challenge studies, which are sometimes used to test vaccines.
“There is no way to turn back time,” said Ms. Seema Shah, a bioethicist at the University of Washington who chaired the panel and is a co-author of the new paper.
“When you’re asking someone to take a risk that won’t benefit them but may benefit others in the future, you need to know two things — that proper protections are in place, and that it’s really going to move the needle.”
With funding from the National Institutes of Health, the investigators plan to inoculate participants with potential vaccines and then to inject them with small doses of the Zika virus to test the vaccines’ effectiveness. The N.I.H. has not yet decided whether the research will proceed.
The scientists leading the trial say it is necessary to prevent a future epidemic. But Ms. Shah and other bioethicists convened by the N.I.H. concluded in 2017 that the research had “insufficient value” to justify the risks.” (J)

“A public warning and call to action, the new book “Lyme: The First Epidemic of Climate Change,” by investigative journalist Mary Beth Pfeiffer, sheds light on a tick-borne disease that recently has emerged to infect hundreds of thousands of people in the United States each year…
“There’s a problem with how we manage Lyme disease,” Pfeiffer said in a recent phone interview. “People need to be aware that we have a long way to go before we get to the point where we can adequately diagnose and treat Lyme disease and other tick-borne diseases.”..
“[Lyme] has been in the environment for millions of years. That we know.” Pfeiffer said. “But it really exploded just as climate change was getting to the point where we were noticing differences in temperature, differences in snowfall, differences in the length of growing seasons and so forth.”
“I ultimately concluded that it was the first major epidemic to move about the planet as a result of climate change,” Pfeiffer said, well aware that some readers may disagree.” (K)

“The White House appeared to declare victory this week for an Obama-era initiative to stamp out disease outbreaks around the world even as it moved to scale back the program.
The National Security Council released a report on Monday trumpeting the achievements of the multinational Global Health Security Agenda, which helps low-income countries halt epidemics before they cross borders. The report “clearly shows how the investments made by taxpayers to improve global health security are paying dividends,” White House officials said in the announcement.
But the United States is set to dramatically shrink its contributions to the initiative, a point that the report omitted. The Centers for Disease Control and Prevention is preparing to narrow epidemic work from 49 countries to 10, an agency spokeswoman said.
That has alarmed health policy experts.
“It’s not a matter of if — but when — there will be another Ebola or Zika, and right now, the world isn’t ready,” said Dr. Thomas R. Frieden, who led the C.D.C. during the West African Ebola outbreak. “Many life-threatening gaps have been identified, but most of them haven’t been closed.” “ (L)

“The response to the Zika virus is fairly typical of both our strengths and weaknesses in dealing with infectious diseases, especially when they emerge. Existing drugs against other viruses were identified as potential therapeutics for Zika, efforts to develop a vaccine are underway and nearing completion, and the concern about Zika spurred some needed and valuable research. Those are encouraging signs, but these efforts were somewhat slow to get started and preceded by the usual complacency. We tend to close the barn door only after most of the horses have escaped.” (M)

(A) Tick and Mosquito Infections Spreading Rapidly, C.D.C. Finds, by DONALD G. McNEIL Jr., https://www.nytimes.com/2018/05/01/health/ticks-mosquitoes-diseases.html
(B) Illnesses on the rise, https://www.cdc.gov/vitalsigns/vector-borne/index.html
(C) Our Planet, Ourselves: How Climate Change Results in Emerging Diseases, by Mariette DiChristina, https://www.scientificamerican.com/article/our-planet-ourselves-how-climate-change-results-in-emerging-diseases/
(D) DSHS reports first 2018 Zika cases in Williamson County, by Natalie Martinez, http://www.fox7austin.com/news/local-news/dshs-reports-first-2018-zika-cases-in-williamson-county
(E) Zika retreats widely, but health experts remain concerned, by Blythe Bernhard, https://medicalxpress.com/news/2018-01-zika-retreats-widely-health-experts.html
(F) Is Zika Gone for Good?, by Jerome Groopman, https://www.newyorker.com/tech/elements/is-zika-gone-for-good
(G) In encouraging sign, Ebola vaccine appears to provide long-lasting protection, by HELEN BRANSWELL, https://www.statnews.com/2018/04/16/ebola-vaccine-lasting-protection/?utm_source=STAT+Newsletters&utm_campaign=189d05d6b0-MR&utm_medium=email&utm_term=0_8cab1d7961-189d05d6b0-149527969
(H) New York Mice Are Crawling With Dangerous Bacteria and Viruses, by KAREN WEINTRAUB, https://www.nytimes.com/2018/04/17/science/urban-mice-viruses-bacteria.html
(I) ‘We’re Out of Options’: Doctors Battle Drug-Resistant Typhoid Outbreak, by EMILY BAUMGAERTNER, https://www.nytimes.com/2018/04/13/health/drug-resistant-typhoid-epidemic.html
(J) Ethicists Call for More Scrutiny of ‘Human-Challenge’ Trials, by EMILY BAUMGAERTNER, https://www.nytimes.com/2018/04/20/health/zika-study-ethics.html
(K) Could Lyme disease be the first epidemic of climate change?, by By Aislinn Sarnacki, http://bangordailynews.com/2018/04/16/homestead/could-lyme-disease-be-the-first-epidemic-of-climate-change/
(L) White House Hails Success of Disease-Fighting Program, and Plans Deep Cuts, by EMILY BAUMGAERTNER, https://www.nytimes.com/2018/03/13/us/politics/trump-ebola-disease-cuts-global-health-security-agenda.html
(M) Cannot be complacent, by Stephen S. Morse, https://www.theweek.in/health/more/2018/05/05/cannot-be-complacent.html

    CURATED CHRONOLOGY OF 2016/ 2017 ZIKA CONUNDRUM & 2018 FLU EPIDEMIC

June 6, 2016
Former hospital prez says: Designate local Zika centers now. Medical experts do not know if, or where, or how much, or on what trajectory the Zika virus may spread across the United States.

August 13, 2016
The ER clerk asked me “How do you spell Zika?

August 19, 2016
With little gudiance about caring for Zika patients, hospitals are planning on their own

September 7, 2016
Hospitals are developing their own Zika preparedness models. Compare the Central Florida and Johns Hopkins approaches! Which template makes more sense?

September 29, 2016
All pregnant women with Zika diagnosed at community hospitals must be referred to academic medical centers for prenatal care!

May 15, 2017
EBOLA is back in Africa. Is ZIKA next? Are we prepared?

June 10, 2017
Study Findings: Five percent of pregnant women with a confirmed Zika infection.. went on to have a baby with a related birth defect

June 21, 2017
When I was a kid the only thing as scary as the polio epidemic was practicing getting under our desks for a nuclear attack…

July 18, 2017
In June WEST NILE was identified nationwide. Today it’s POWASSAN VIRUS. – ARE WE PREPARED FOR A SURGE OF EMERGING MOSQUITO AND TICK BORNE VIRUSES?

July 20, 2017
“Houston Braces for Another Brush With the Peril of Zika” *. But they are doing passive not active surveillance. IS YOU AREA’S HEALTH CARE SYSTEM PREPARED FOR A SURGE OF AN EMERGING VIRUS LIKE ZIKA?

July 27, 2017
Locally transmitted ZIKA case in Texas! Are we ready?

October 11, 2017
CDC deactivated its emergency response center for Zika.. The first probable locally acquired Zika case in 2017 has been confirmed in Texas….

November 7, 2017
a hand held device (was used) to measure the germ-count on some of New York City’s dirtiest surfaces

January 8, 2018
“We are arguably as vulnerable—or more vulnerable—to another (flu) pandemic as we were in 1918.”

January 11, 2018
In the ICU at Massachusetts General Hospital, nurses use Gatorade to combat flu-related dehydration (due to shortages of intravenous fluids)

January 15, 2018
The CDC postponed its briefing on preparation for nuclear war and will focus on responding to severe influenza

January 17, 2018
“Think hospitals are under a strain now, from a slightly bad flu season? Wait until a really bad one hits.”

January 20, 2018
Government Shutdown. “The CDC would furlough key staff amid one of the most severe flu seasons in recent memory….”

January 23, 2018
“..in a severe (flu) pandemic, the U.S. healthcare system could be overwhelmed in just weeks.

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From REPEAL & REPLACE to WRECK & REJOICE (from Obamacare to Trumpcare)

On March 24th, 2017. “Speaker Paul Ryan (R-Wis.) on Friday said his party “came up short” in a news conference minutes after pulling the GOP healthcare bill off the House floor, acknowledging that ObamaCare will stay in place “for the foreseeable future.””

Yet on December 20th, 2017 the INDIVIDUAL MANDARE was repealed. ““When the individual mandate is being repealed that means ObamaCare is being repealed,” Trump said…“We have essentially repealed ObamaCare, and we will come up with something much better…”

“Andy Slavitt, who served as the acting administrator for the Center for Medicare and Medicaid Services under President Barack Obama, warned late Friday night that Republicans may try to repeal and replace Obamacare once again before the 2018 midterm elections. “Republicans have been meeting in secret to bring back ACA repeal,” he writes…
… Santorum and others may think that there will be a “blue wave” in 2018 no matter what, so this may be the last time the GOP has the opportunity to get rid of Obamacare. And that might make Republicans desperate enough to try again.” (R)

At the end of this post there are links to a series of over 60 posts tracking the activity between March 24th and December 20th. Laws are like sausages,” goes the famous quote often attributed to the Prussian Chancellor Otto von Bismarck, “it is better not to see them being made.”

In 2018, mostly under-the-radar, efforts are continuously underway to continue to undermine what’s left of ObamaCare.

“Republicans, having failed to repeal Obamacare, have stumbled, almost accidentally, into replacing it. For better and for worse, and with little coherent vision at work, they are making Obamacare their own. And over time, they are likely to embrace it…,
Congress has already repealed several unpopular parts of the law as part of last year’s tax legislation — most notably the individual mandate, which now expires at the end of this year, but also the Medicare cost-control board (known as the Independent Payment Advisor Board).
The executive branch has exerted its own influence on the law. In October of last year, President Trump signed an executive order calling for the expansion of association health plans and limited-duration insurance, in hopes of creating a secondary market for health plans that are cheaper and less regulated, and this year, the administration released extensive proposals for each. The administration also stopped paying the law’s cost-sharing reduction subsidies, which reimburse insurers for low-income beneficiaries. And the Department of Health and Human Services has begun allowing states to attach work requirements to Medicaid, making the program more bureaucratic, but possibly enticing red states that have so far declined to expand the program to do so…
Having failed in their repeal effort, Republicans are now in something of an arranged marriage with the health care law. These alterations are being made in a predictably haphazard fashion, with little in the way of guiding theory, but the cumulative effect is to turn Obamacare into a law that they can, if not love, at least learn to live with.”(A)

“Bigger changes are coming. The administration has proposed regulations that would allow so-called short-term health plans to be offered for nearly a year of coverage. Those plans aren’t subject to any Obamacare rules in most states, and are likely to be marketed aggressively. They are likely to cover fewer health services and be available only to the healthy — but at a lower price. Another pending rule would expand the availability of association health plans, a form of group insurance purchasing that may be attractive to small businesses looking for cheaper, less comprehensive options….
People buying those plans may face some unpleasant surprises. The plans are likely to require applicants to fill out detailed health histories, and to exclude those with prior illnesses. They also are likely to exclude or limit services — like addiction treatment, maternity care or prescription drugs — that all Obamacare plans require. Association plan buyers have tended to have problems with fraud. And some short-term plans have a history of declining to pay for serious illnesses after the fact.
But even if the new plans serve their customers well, their popularity could leave the remaining markets a bit shakier. Because the short-term plans will be open only to the healthy, the remaining customers will tend to be sicker, and more expensive to insure.” (B)

“It’s been well documented that the Trump White House has filled federal agencies with bureaucrats whose life work is destroying the very agencies they’ve been assigned to. But one is in a better position than her fellows to threaten the health of millions of Americans—and she’s been working at that assiduously.
We’re talking about Seema Verma, who as administrator of the Centers for Medicare and Medicaid Services also is effectively the administrator of the Affordable Care Act. In the Trump administration, that has made her the point person for the Trump campaign to dismantle the act, preferably behind the scenes…
Still, Verma had spent enough time in the healthcare field that observers thought she might not be totally egregious as CMS administrator. But then, during her confirmation hearing in February 2017, she let on that she didn’t see why maternity coverage really needed to be mandated for all health policies, since “some women might want maternity coverage, and some women might not want it…
It wasn’t an auspicious start. But since then she has lived down to our expectations. Verma never has concealed her hostility to Medicaid — especially Medicaid expansion, a provision of the ACA. Her animosity is fueled at least in part by ignorance (willful or otherwise) about the program. Back in November, on the very day that voters in Maine and Virginia were demonstrating full-throated support at the polls for expanding Medicaid in their states, Verma was unspooling a string of misleading statistics and suspect assertions about the program to support a policy of rolling back enrollment.” (C)

“Passing two measures aimed at stabilizing the Affordable Care Act marketplaces by infusing insurers with more funds would lower monthly premiums by 20 to 40 percent and prompt an additional 3.2 million people to get covered, says an attention-grabbing independent analysis released yesterday by the firm Oliver Wyman.
These measures – which would pay insurers for extra cost-sharing discounts for the low-income and reimburse them for their most expensive customers – are currently stuck in political limbo as leaders on Capitol Hill consider whether to include them in a massive, must-pass spending bill next week.
The bills have become emblematic of inter and intraparty disputes over how to approach a world with most of the ACA still in place. Democrats are bitter that Republicans are still chipping away at parts of the law by repealing its individual mandate and changing other provisions through the executive branch…
And Republicans can’t even agree among themselves how to handle the law now that they’ve failed to entirely wipe it from the books. (D)

“Republicans campaigned for roughly a decade, promising voters they would dismantle former President Barack Obama’s landmark health care legislation; but one of their own senators is trying to keep it alive through the 2018 election cycle…
Sen. Lamar Alexander, R-Tenn., along with Sen. Patty Murray, D-Wash., is using the deadline to sway leadership to include a proposal that would fund politically contentious Obamacare subsidies through 2019. The proposal would provide $10 billion a year for three years for these subsidies…
Additionally, the proposal would give states greater Obamacare waiver flexibility and would broaden consumer eligibility for “copper” plans. Abortion-covering health insurance plans would not receive subsidies under the proposal…
Republicans are either not thrilled about Alexander’s proposal, calling it a bad idea and one that could hurt the party going into 2018, or they think it could be one way to provide taxpayers some relief from the financial burdens Obamacare imposed.” (E)

“The House passed the $1.3-trillion omnibus spending package meant to keep the government running until Sept. 30 in a vote of 256-167, leaving the Senate barely 35 hours to get the same legislation approved by Friday at midnight to avert a shutdown.
The bill boosts funding for the National Institutes of Health, the CDC, and the Department of Veterans Affairs (VA) as well as other key agencies, but keeps funding flat for the Centers for Medicare and Medicaid Services…
The bill also does not include the health insurance stabilization bill from Sen. Lamar Alexander (R-Tenn.) and Sen. Susan Collins (R-Maine). They had wanted the omnibus package to include measures restoring for 3 years the cost-sharing reduction subsidies (monies that help insurers defray out-of-pocket costs for low-income enrollees), establishing 3 years of reinsurance (monies that help pay for the sickest of patients and keep premiums from spiking) at $10 billion per year, and streamlining the 1332 waiver process to allow states more flexibility in health plan design.” (F)

“The Trump administration hopes to move forward with a rule expanding alternatives to ObamaCare plans by this summer, Secretary of Labor Alex Acosta said Monday. The rule allows small businesses and self-employed individuals to band together to buy insurance as a group in what are known as association health plans. “We hope to have that by this summer,” Acosta said Monday during a tax reform event alongside President Trump in Florida.” (G)

“In 2012, the Supreme Court of the United States upheld Obamacare in a 5-4 ruling, with Chief Justice John Roberts writing the majority opinion. Many Obamacare opponents believe Roberts used contorted reasoning to save the law by labeling Obamacare’s individual mandate penalty a tax.
Now, six years later, 20 states have seized on the Roberts ruling to ask the courts again to undo Obamacare. These states filed a lawsuit indicating that because the December 2017 tax reform bill repealed the individual mandate penalty, there’s no longer any legal rationale for the mandate. They also argue that because there’s no “severability clause” in Obamacare, the entire law must be struck down.
If this sounds confusing, read on to unpack what’s going on with this latest attempt to undo Obamacare through the courts.
The Obamacare mandate was ruled a tax…
Opponents of the law argued Congress didn’t have the power to require individuals to purchase a product from private insurers, while the Obama administration argued authority for the mandate came from the Commerce Clause, which gives the federal government power to regulate commerce “among the several states.”” (H)

“Gov. Scott Walker has asked for a federal waiver to operate a state-based reinsurance plan designed to stabilize the state’s individual health insurance market and hold down premiums under the Affordable Care Act.
Following a 44 percent average spike in Obamacare premiums this year, Walker’s office estimates the $200 million program would lower premiums by 11 percent from what they otherwise would have been, amounting to a 5 percent decrease in premiums compared to 2018.
Under the plan, the state would pay $34 million for reinsurance in 2019, while $166 million would come from federal funds…
“We are taking action to address the challenges created by Obamacare and bring stability to the individual market,” Walker said. “Our Health Care Stability Plan provides a Wisconsin-based solution to help stabilize rising premiums in order to make health care more affordable for those purchasing in the individual market. With Washington D.C. failing to fix our nation’s health care system, Wisconsin must lead.” (I)

“The American Academy of Family Physicians and other doctor groups have unleashed detailed critiques of Trump’s effort to introduce cheaper health insurance with skimpier benefits….
“Insurers could reduce or eliminate certain essential health benefits to avoid vulnerable, expensive patients by excluding specific services,” AAFP board chair Dr. John Meigs, Jr., a family physician from Alabama wrote in a letter last week to U.S. Health and Human Services Secretary Alex Azar.
“In doing so, insurers could potentially make plans more expensive for people with long-term chronic conditions or with sudden medical emergencies,” Meigs said. “Inadequate benefits could leave this population with too little coverage to meet their health care needs.” (J)

“The Affordable Care Act (aka Obamacare) banned any hospital, doctor, or insurance company who receives federal funding from discriminating against or denying services based on sex; the Obama administration made it clear in 2016 that provision included transgender and gender-nonconforming patients…
These benefits and protections are heading for oblivion though, according to the Times. The Trump administration is pointing to a January 2017 ruling from a Texas federal judge who said the 2010 law did not cover gender identity or presentation.
“Congress did not understand ‘sex’ to include ‘gender identity,’” Judge Reed O’Connor ruled. In the Affordable Care Act, he said, Congress “adopted the binary definition of sex.” (K)

“As Republicans careen toward the midterms with tax reform under their belts and not much else, rumor has it that a small group of Republican senators are working with the White House and former Sen. Rick Santorum (R-Pa.) to revive the debate over ObamaCare repeal.
Their purpose is laudable. But, privately, conservatives across Capitol Hill are expressing concern that the proposal may not do enough to dismantle ObamaCare’s regulatory structure, reduce its colossal spending, or allow freedom to innovate outside the law’s stifling framework…
The bill’s premise — to devolve much of the health-care spending to the states — is a good starting point. But its implementing details are still unknown, leaving conservatives to wonder if the new bill will actually repeal ObamaCare and reform the health-care marketplace, or if it will simply recast much of the law’s worst elements with a few minor tweaks…
Voters are still waiting for a full repeal effort. Anything less will not suffice as a solution for candidates who will soon be elected on a message of repeal. Nor will it suffice for a party who has spent years making the same promise.” (L)

“Less than a year after the GOP gave up on its legislative effort to repeal the law, Democrats are going on offense on this issue, attacking Republicans for their votes as they hope to retake the House majority…
ObamaCare’s favorability in polls has improved since the repeal push last year, with more now favoring the law than not. A Kaiser Family Foundation poll in March found that 50 percent of the public favors the law, while 43 percent holds an unfavorable view.
GOP strategist Ford O’Connell said the political winds have shifted on the issue, turning ObamaCare into a subject Democrats want to tout and many Republicans want to duck.
“I don’t think it’s seen as a winning issue,” he said. “It’s also an issue that tends to fire up the Democratic base more so than the Republican base.”” (M)

“While Republican moves to overhaul Social Security, Medicare or Medicaid appear unlikely — at least for this year — Democrats are increasingly warning about the prospect because of the deficit concerns created by the tax plan. The GOP argues Democrats want to distract from the fact that they did not support the tax overhaul, the signature Republican achievement of Trump’s first year in office.
Democrats’ ability to sell voters on their vision for health care and warn about the possibility of cuts to Social Security and Medicare could prove crucial for candidates, such as Manchin, who are trying to win in red areas…
Polling suggests Trump and the GOP’s efforts to reshape the American health-care system have not resonated with voters. Thirty-six percent of respondents to the Economist/YouGov poll said they strongly disapprove of how the president has handled health care, compared with only 15 percent who said they strongly approve.” (N)

“People have voted with their enrollment decisions: A sizable number of Americans do not get insurance from their employers and value the coverage on Obamacare’s markets. That refutes the GOP myth that the program forces Americans to purchase junk insurance that they do not want. A recent Kaiser Family Foundation poll found that these consumers seek to guard against major medical costs, to gain the peace of mind that comes with insurance and to obtain coverage for chronic medical care, suggesting that the law serves important and durable needs.
Another fictional Republican claim is that Obamacare has been collapsing. A Kaiser study this year found that insurance markets stabilized in 2017, despite Mr. Trump’s best efforts to undermine the law. This comports with findings from the Congressional Budget Office and a range of other independent analysts…
Obamacare continues to serve an important need. What’s sad to see is how easy it would be to make it even more useful, if Republicans would focus on improvement instead of sabotage.” (O)

“What’s the secret of Obamacare’s stability? The answer, although nobody will believe it, is that the people who designed the program were extremely smart. Political reality forced them to build a Rube Goldberg device, a complex scheme to achieve basically simple goals; every progressive health expert I know would have been happy to extend Medicare to everyone, but that just wasn’t going to happen. But they did manage to create a system that’s pretty robust to shocks, including the shock of a White House that wants to destroy it…
What this says to me is that if Republicans manage to hold on to Congress, they will make another all-out push to destroy the act — because they’ll know that it’s probably their last chance. Indeed, if they don’t kill Obamacare soon, the next step will probably be an enhanced program that lets Americans of all ages buy into Medicare.” (P)

“At the outset, Obamacare had three central features:
• Insurers could not charge higher prices to people with pre-existing conditions.
• Those without coverage had to pay a penalty to the government (the “mandate”).
• Low-income people would be eligible for subsidies.
The first two provisions were necessary to prevent the death spiral, and government couldn’t mandate insurance purchases without adding subsidies for the poor.
Despite a bumpy rollout and some frustrations over shrinking choices and rising prices at health care exchanges, Obamacare was working remarkably well by most important metrics. Program costs were much lower than expected, and the uninsured rate among nonelderly Americans fell sharply — from 18.2 percent in 2010 to only 10.3 percent in 2018.
This progress is now imperiled.
The mandate — by far the program’s least popular provision — was repealed as part of tax legislation passed in December 2017. And because economists predict that its absence will slowly rekindle the insurance death spiral, we’re forced back to the policy drawing board… (Q)

SEE OBAMACARE/ TRUMPCARE CHRONOLOGY AFTER THE FOOTNOTES

(A) The G.O.P. Accidentally Replaced Obamacare Without Repealing It, by Peter Suderman https://www.nytimes.com/2018/03/12/opinion/republicans-obamacare-health-care.html
(B) Republicans Couldn’t Knock Down Obamacare. So They’re Finding Ways Around It., by Margot Sanger-Katz, https://www.nytimes.com/2018/04/11/upshot/republicans-couldnt-knock-down-obamacare-so-theyre-finding-ways-around-it.html
(C) How Trump’s Obamacare administrator is taking a hatchet to Obamacare, by Michael Hiltzik, http://www.latimes.com/business/hiltzik/la-fi-hiltzik-obamacare-verma-20180417-story.html
(D) The Health 202: Republicans could lower Obamacare premiums. But will they?, by Paige Winfield Cunningham, https://www.washingtonpost.com/news/powerpost/paloma/the-health-202/2018/03/13/the-health-202-republicans-could-lower-obamacare-premiums-but-will-they/5aa6a81330fb047655a06c0d/?utm_term=.923a4143e8d5
(E) Senate May Fund Obamacare Subsidies With This Sneaky Move, by Robert Donachie, https://www.dailysignal.com/2018/03/15/senate-is-going-to-fund-obamacare-subsidies-with-this-sneaky-move/
(F) House Passes Spending Bill Without Obamacare Fix, by Shannon Firth https://www.medpagetoday.com/publichealthpolicy/healthpolicy/71945
(G) Trump Official: Alternative to ObamaCare Plans Likely This Summer, by Peter Sullivan, http://galen.org/2018/obamacare-watch-newsletter-4-20-18/
(H) States Take Another Run at Undoing Obamacare Through the Courts, by Christy Bieber, https://www.fool.com/investing/2018/04/22/states-take-another-run-at-undoing-obamacare-throu.aspx
(I) Amid rising Obamacare premiums, Walker seeks federal waiver for reinsurance program, by op 5 percent, by Lauren Anderson, https://www.biztimes.com/2018/ideas/government-politics/amid-rising-obamacare-premiums-walker-seeks-federal-waiver-for-reinsurance-program/
(J) Doctors Attack Trump’s Short-Term Health Plans Ahead Of Comment Deadline, by Bruce Japsen, https://www.forbes.com/sites/brucejapsen/2018/04/22/doctors-attack-trumps-short-term-health-plans-ahead-of-comment-deadline/#9049bad3fb10
(K) Trump to Allow Anti-Trans Discrimination in Health Care, by BY NEAL BROVERMAN, https://www.advocate.com/transgender/2018/4/22/trump-allow-anti-trans-discrimination-health-care
(L) Republicans have a long way to go toward fully repealing ObamaCare, by Rachel Bovard, http://thehill.com/opinion/healthcare/383722-republicans-have-a-long-way-to-go-toward-fully-repealing-obamacare
(M) GOP in retreat on ObamaCare, by BY PETER SULLIVAN, http://thehill.com/policy/healthcare/384032-gop-in-retreat-on-obamacare
(N) It’s not all about Trump: Democrats’ midterm chances ride on health care and Social Security, too, by Jacob Pramuk, https://www.cnbc.com/2018/04/16/not-just-trump-health-care-social-security-could-define-2018-midterm-elections.html
(O) Americans are sticking by Obamacare. If only the GOP would stop trying to kill it., https://www.washingtonpost.com/opinions/americans-are-sticking-by-obamacare-if-only-the-gop-would-stop-trying-to-kill-it/2018/04/15/9b817832-3c2b-11e8-a7d1-e4efec6389f0_story.html?noredirect=on&utm_term=.e10e892994e9
(P) Obamacare’s Very Stable Genius, by Paul Krugman, https://www.nytimes.com/2018/04/09/opinion/obamacare-trump.html
(Q) Back to the Health Policy Drawing Board, by ROBERT H. FRANK, https://www.nytimes.com/2018/03/16/business/back-to-the-health-policy-drawing-board.html
(R) Health Policy Expert Says Republicans Have ‘Secret’ Plan to Repeal Obamacare, by Cody Fenwick, https://www.alternet.org/news-amp-politics/health-policy-expert-says-republicans-have-secret-plan-repeal-obamacare

OBAMACARE/ TRUMPCARE CHRONOLOGY

March 26, 2017
LESSONS LEARNED: TrumpRyanCare Obits

March 29, 2017
Let’s prohibit Congressmen from insurance reimbursement for Prostate Screening and Treatment

May 6, 2017
Repeal and DESTROY Obamacare

May 24, 2017
Hard to believe a congressman said NOBODY DIES BECAUSE THEY DON’T HAVE ACCESS TO HEALTH CARE

June 16, 2017
REVISE and RECALIBRATE Obamacare. Prevent Republican’s “mean” plan.

June 23, 2017
Is there more “heart” in the Senate health care bill? Or is it “meaner” than the House bill?

June 29, 2017
Perry Como sang “There’s no place like home for the holiday”….except for Republican Senators with their TrumpCare albatross

July 4, 2017
REPEAL NOW/ REPLACE LATER: “Nothing like rolling a hand grenade into ongoing negotiations…”

July 6, 2017
Cruz health care bill amendment – “….healthy people could get coverage although that coverage might not protect them if they got sick and sick people would have to pay an unaffordable amount for coverage.”

July 9, 2017
SLOW DOWN & START OVER (policy) versus REPEAL & REPLACE (politics)

July 12, 2017
What would Albert Einstein have said about TrumpCare? “The definition of insanity is doing something over and over again and expecting a different result.”

July 13, 2017
Is the new Senate health proposal a responsible bill or just “stuff” to get 50 votes?

July 15, 2017
Republican Talking Points on the new Senate Health Care Bill. Democratic Party response – “Senate Republicans spent the past two weeks putting lipstick on a pig”

July 16, 2017
Last week Senator McCain said the “Senate healthcare deal could be reached by Friday ‘if pigs fly’” (A). Now he has a deciding vote on the Republican “junk insurance” bill!

July 17, 2017
“Laws are like sausages, it is better not to see them being made.” (Otto von Bismarck). Or not made…two conservative Republican Senators kill TrumpCare….for now

July 18, 2017
After another day of Republican health care bill fiascos: “President Trump: ‘Let Obamacare Fail…I’m Not Going to Own It’

July 19, 2017
Are Republicans going to LET Obamacare die or MAKE it die? How can the individual market exchanges be stabilized?

July 20, 2017
“The vote is a reward to the ultras who sabotaged repeal and replace by allowing them to posture one more time as purists who have not forsaken the true faith.”

July 21, 2017
“McConnell is still planning votes on health-care legislation next week. But many things have to go right for his strategy to succeed, and not all of them are within his control.”

July 22, 2017
“….. the parliamentarian has taken an already very difficult process for enacting health care legislation in the Senate and made it nearly impossible….”

July 23, 2017
New York Daily News editorial: Senate Republican vote –“An embarrassment wrapped in cruelty wrapped in political disaster.”

July 24, 2017
Rep. Blake Farenthold (R-Texas) suggested….that he’d like to duel with female senators he blames for the Senate’s failure to repeal and replace ObamaCare

July 25, 2017
“These are the moments legislatively when you get creative. We’re getting creative.”

July 26, 2017
“It is clear that Mr. McConnell does not much care which of these proposals the Senate passes…. — he just wants to get a bill out of the Senate.”
http://doctordidyouwashyourhands.com/?s=It+is+clear+that+Mr.+McConnell&submit=Go

July 27, 2017
Senator Graham said he could not support a “half-assed” plan that he called “politically” the “dumbest thing in history.”

July 28, 2017
The House and Senate played “dodgeball” not wanting to be held accountable when twenty million people, their constituents, would lose access to affordable care.

July 29, 2017
What Congress, President Trump and Former President Obama are saying about healthcare

August 6th
“.. here’s the first thing I thought about: feel better, Hillary Clinton could be president..” (Senator McConnell) (A) “McCain Voted Against Health Care Bill…Because it Would ‘Screw’ Arizona.” (B)

August 10, 2017
“In politics you can tell your friends from your enemies, your friends are the ones who stab you in the front”.* Look at what the Republicans are saying about each other now about health care

August 16, 2017 |
The Trump administration “blinks”; provides Obamacare funding

August 23, 2017
For 17 years I was President and CEO of a safety net hospital. TrumpCare will “disinsure” twenty million+ people and devastate the hospitals we all depend on.

August 23, 2017
Trump told a GOP senator she could only ride on Air Force One if she voted for the healthcare bill.

September 3, 2017
TrumpCare. “If you don’t know (`or care`) where you’re going, any road will get you there.” – Lewis Carroll

September 8, 2017
“Republican plans to replace Obamacare are fading fast, but that doesn’t mean Congress is done with health care.
http://doctordidyouwashyourhands.com/?s=Republican+plans+to+replace+Obamacare+are+fading+fast%2C&submit=Go

September 16, 2017
“Senators on the health committee are working over the weekend to try to reach an agreement on a stabilization bill for Obamacare…”

September 19, 2017
President Trump would sign the Graham-Cassidy bill if the legislation to repeal Obamacare makes it to his desk…. IT JUST MIGHT MAKE IT THERE!

September 20, 2017
TRUMPCARE. “This is the choice for America, Mr. Graham said on Tuesday: “Socialism or federalism when it comes to your health care.””

September 21, 2017
President Trump tweeted he ”.. would not sign Graham-Cassidy if it did not include coverage of pre-existing conditions. It does! A great Bill. Repeal & Replace.” IT DOESN’T!

September 22, 2017
“It ain’t over till it’s over.” (Yogi Berra). But, John McCain said he “cannot in good conscience vote for the Graham Cassidy proposal.”

September 23, 2017
TrumpGrahamCassidy. “Perhaps one of the biggest challenges for the bill will come next week when the Senate parliamentarian — an umpire of sorts for the chamber’s rules — takes a look at the bill…”
http://doctordidyouwashyourhands.com/?s=TrumpGrahamCassidy.+%22Perhaps+one+of+the+biggest+challenges&submit=Go

September 24, 2017
White House Director of Legislative Affairs Marc Short is defending the proposed Graham-Cassidy bill — – by countering criticism that the bill does not provide coverage for those with pre-existing conditions.

September 25, 2017
TRUMP/ GRAHAM/ CASSIDY. “If there’s a billion more going to Maine … that’s a heck of a lot,” Cassidy said.

September 26, 2017
“I personally think it’s time for the American people to see what the Democrats have done to them on health care,” said Senate Finance Committee Chairman Orrin G. Hatch (R-Utah).

September 27, 2017
Last minute Sunday night Graham Cassidy revisions included.. a pretty sweet deal for the state of Louisiana, home of one of the bill’s sponsors Sen. Bill Cassidy.

September 28, 2017
LINDSEY GRAHAM ON OBAMACARE REPEAL: I HAD NO IDEA WHAT I WAS DOING

September 29, 2017
“Senate Republicans Commence Health Care Blame Game” – pointing fingers at each other. (But..Is a bipartisan deal next?)

October 1, 2017
Senator Cassidy a candidate for Health and Human Services Secretary?

October 2, 2017
Access to health care….should be considered “privileges” for those who can afford them

October 8, 2017
Trump: “I want to focus on North Korea not ‘fixing somebody’s back’,…Let the states do that.” As “synthetic repeal” of ObamaCare is underway.

October 12, 2017
Trump’s Executive Order: “By siphoning off healthy individuals, these junk plans could cannibalize the insurance exchanges.”

October 15, 2017
Trump vows to rip apart Obamacare piece by piece

October 18, 2017
“… President Donald Trump on Wednesday backed away from a bipartisan deal on healthcare reached by two senators…

October 31, 2017
Ending the subsidy for copays/ deductibles would increase the subsidy for premiums ..and ObamaCare enrollment would grow

November 9, 2017
President Trump and Republican congressional leaders falsely claim that Obamacare… is in a “death spiral.”

November 14, 2017
Senate Republicans include repeal of Obamacare’s individual mandate in the tax bill

November 20, 2017
The Republican deal with itself: repeal the Obamacare individual mandate and stabilize the individual health insurance market?

November 26, 2017
“The White House is trying kill Obamacare. Americans are throwing it a lifeline.”

November 30, 2017 | Edit
“The Senate tax bill is really a health care bill with major implications for more than 100 million Americans…..

December 2, 2017 |
“..Conference Committee “may not change a provision on which both houses agree, nor may they add anything that is not in one version or the other,”…

December 6, 2017
“…House and Senate Republicans will likely scrap Obamacare’s individual mandate in their final tax bill.”

December 8, 2017
..congressional Republicans aim to reduce spending on federal health care programs to reduce America’s deficit

December 10, 2017
Note to Sen Collins: Look Around the Poker Table- If You Can’t See the Patsy, You’re It! *

December 14, 2017
“..the compromise tax bill from House and Senate negotiators will end the health law’s requirement that all individuals buy insurance or pay a fine….”

December 17, 2017
“ the move is a winner for Republicans, who.. would otherwise have little to show for 7 years of…repeated efforts to kill Obamacare..”

December 19, 2017
“….57 % of Americans now approve of Obamacare. Only 29 % approve of the GOP’s tax cuts.”

December 20, 2017
By ending the Individual Mandate Republicans are “showing they have no clue how insurance works.”…or don’tcare…

December 21, 2017
President Trump: “When the individual mandate is being repealed that means ObamaCare is being repealed”

December 23, 2017
“It leaves us with two laws… Call the first one Obamacare… Call the second one Trumpcare”

January 10, 2018
“wreck and rejoice” – has consequences. BTW, there is a congressional exemption from ObamaCare

January 24, 2018
GOP Rep. Blames Obamacare For Sexual Harassment Allegations

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Why is there a nationwide hospital shortage of injectable opioids? – follow the money. (part 3 of a continuing case study on the opioid crisis)

“The incident command system kicked in at Brigham and Women’s Hospital about a week ago. A large team of doctors, pharmacists, and nurses began assembling every morning to confront an emerging crisis with the potential to severely undermine care for patients.
The challenge was different than it was during the Boston Marathon bombing, another event that triggered the command response. This one wasn’t rushing toward caregivers as fast. But it was similarly daunting and logistically demanding: Amid a nationwide crisis caused by too-easy access to medical painkillers, hospitals are now struggling to find enough of that same class of drugs to keep their patients’ pain controlled.
That is the reality now facing Brigham and Women’s and other medical providers across the country. Production of injectable opioids has nearly ground to a halt due to manufacturing problems, creating a shortage of staple medications used to treat a wide array of patients. Alarms are now ringing at all kinds of medical providers, from sprawling academic hospitals to small hospice programs, and many are launching efforts to conserve injectable opioids and institute safeguards to prevent dosing errors that can result from rapid changes in medication regimens.” (A)

“The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs needed for patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.
As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.
In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which is about 10 times more powerful than fentanyl, which was the ideal medication for that situation.
In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can. Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases. Others patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.” (B)

The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.
Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.
Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.
Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.
Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.
“The system has been set up safely for the drugs and the care processes that we ordinarily use,”…“You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”
Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.
“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.” (C)

Experts say opioid pills are most often the culprits behind this abuse. It is not those drugs, but the liquid form that hospitals depend upon for general surgery, sedation, trauma treatment and pain management. And it is those drugs — namely ketamine, fentanyl and hydromorphone — that are in critically low supply.
Pfizer, a major injectable drug supplier, had to stop production of the medications after the Food and Drug Administration found problems at a manufacturing facility in Kansas. Work to upgrade the facility took longer than expected, Pfizer wrote in a letter to its customers in November.
In that letter, Pfizer said syringes would not be available until 2019.
Roper St. Francis’ medication safety officer, Kim Gaillard, said the system gets 60 percent of its IV opioid drugs from Pfizer…
Clinicians have had to find solutions. Gaillard was sure to stress there are other medications in many cases. Other types of painkillers have worked just as well in some surgeries, she said. The shortage has led the hospital system to speed up its review of different ways to deal with pain.
“I know that this is alarming,” Gaillard said, “but we have other strategies.”
Leaders at MUSC restricted ketamine, fentanyl and hydromophone to the system’s intensive care unit, emergency department and operating rooms. An email circulated to MUSC prescribers cited “critical shortages.”
Clinicians were told they need to convert all patients to morphine, if possible. The email warned further restrictions are possible.
Heather Easterling, administrator of pharmacy services at MUSC Medical Center, said in a statement the pharmacy team is working with wholesalers every day to order more of the medications. The DEA’s restrictions are at the heart of the issue, she said.
The DEA’s quotas are quarterly, so Easterling said the shortages hospitals are seeing may continue at least until mid-April.” (D)

“This fact sheet provides an outline of potential actions for organizations to consider in managing the acute shortages of injectable hydromorphone, morphine, and fentanyl. Healthcare professionals should use their professional judgment in deciding how to use the information in this document, taking into account the needs and resources of their individual organizations.
Critical importance
Shortages of injectable opioids can be particularly challenging due to the range of uses in various healthcare settings, including emergency response, ambulatory surgery centers, and hospitals. Injectable opioids are used for acute, acute-on-chronic, or chronic pain that cannot be controlled by other pain management options. Some injectable opioids are used for sedation or anesthesia. Intermittent shortages of specific injectable opioids may require institutions to convert temporarily to a more available product. Not all injectable opioids are interchangeable for all indications. Improper conversion between morphine and hydromorphone caused two deaths during a similar shortage in 2010.
ISMP Medication Error Reporting
ASHP encourages the reporting of any medication errors related to drug shortages to the Medication Error Reporting page on the Institute for Safe Medication Practices (ISMP) website.
What can clinicians do to mitigate the impact?
• Switch therapy to a clinically appropriate oral or enteral opioid whenever possible. o The Pharmacy and Therapeutics (P&T) committee should review current IV-to-oral policies; there may be an opportunity to expand policies to include drug classes affected by shortages.
• Provide multimodal pain management by using parenteral and enteral alternatives to opioids. Consider nonpharmacologic treatments, local nerve blocks, or other pharmacologic adjuncts, as appropriate.
• Engage the institution’s experts in anesthesia and pain and palliative medicine to further develop guidance and formulate strategies for dealing with intermittent shortages.
• Ensure relevant institutional pain medication guidelines are up to date. o To reduce the risk of conversion errors, use a uniform opioid conversion tool that is approved by the anesthesia team and the P&T committee and distributed throughout the entire health system. o Resources like the ASHP Demystifying Opioid Conversion Calculations reference may be helpful in establishing guidelines.
• Product availability can vary by wholesaler and may change from week to week. Guiding prescribers to choose between the available injectable opioids can help institutions reserve certain opioids for specific populations or indications (for example, reserve fentanyl for operating-room use). Use systemwide communications to alert all clinicians who prescribe, dispense, or administer injectable opioids.
• Ensure the electronic health record (EHR) displays opioid options that match the products currently in stock. Do not underestimate the informatics resources that will be needed during this shortage. Inventory control strategies
• Consider reserving supplies of specific injectable opioids for specific indications and limiting the placement.” (E)

“Regrettably, we believe the forecast for drug shortages is grim. There is little relief in sight to halt the rapid escalation of shortages in large part because the conditions that lead to shortages are varied and FDA lacks the necessary regulatory authority to proactively manage potential shortages. It is not always clear what causes drug shortages, as drug companies are not required to disclose the underlying reason or notify FDA regarding a decision to stop production unless they are the sole-provider of the product and it is a medically necessary product. Few manufacturers will supply letters to healthcare providers regarding the reason behind the shortage and the anticipated duration, which is very frustrating to healthcare personnel. The drug shortage lists maintained on the ASHP and FDA Web sites attempt to provide a reason for the shortage in very general terms.
Some of the more common reasons for drug shortages include the following:
– Unavailability of bulk and raw materials used to produce pharmaceuticals, of which 80% come from outside the US
– A delay or halt of production in response to an FDA enforcement action regarding noncompliance with good manufacturing practices identified during an inspection
– Voluntary recall of a drug after the manufacturer discovers a problem with the medication, such as inadvertent bacterial or fungal contamination
– Change in the manufacturer or product formulation (e.g., inhalers without chlorofluorocarbons) that delays production
– Manufacturer’s business decision to halt production of a drug due to availability of generic products, patent expiration, market size, drug approval status, regulatory compliance requirements, anticipated clinical demand, and/or reallocation of resources to other products (FDA does not have authority to require a company to continue manufacturing a medically necessary product)
– Manufacturer mergers that narrow the focus of product lines, causing discontinuation of certain products, or move production of a drug to a new facility, causing production delays
– Poor inventory ordering practices, stockpiling before price increases, and hoarding caused by rumors of an impending shortage
– Unexpected increases in demand for a drug when a new indication has been approved, usage changes due to new therapeutic guidelines, or a substantial disease outbreak occurs
– Natural disasters that involve manufacturing facilities or that lead to demands for certain classes of medications to treat disaster victims.” (F)

“Other companies can’t make up the difference because they don’t have the capacity. Even if they did, the Drug Enforcement Administration is unwilling to give them large amounts of raw materials. The DEA implements annual caps on the amount of raw material a manufacturer can use to make opioids—one mechanism it has to try to limit the diversion of the addictive drugs amid the addiction epidemic.
The DEA has not shifted those caps to allow other manufacturers to produce enough to offset the shortage of injectable narcotics, according to Premier, which has advocated for the agency to loosen its quota restrictions.
“We understand and support the DEA’s goal to be judicious about the production of narcotics, but we believe we are in the midst of a public health crisis,” Mike Alkire, chief operating officer of Premier, said in a statement. “A temporary reallocation of supply quotas would allow others to step into the void, potentially addressing a multi-year shortage in a matter of months.”
Injectable opioids aren’t the ones getting diverted, said Scott Knoer, chief pharmacy officer at Cleveland Clinic.
“We have to do something to try to limit controlled substances, but limiting injectable opioids is not helpful for patients who need them,” he said. “ (G)

“The Drug Enforcement Administration has raised production quotas for drug manufacturers Fresenius Kabi and West-Ward Pharmaceuticals to mitigate the shortage of opioid injectables, but relief is likely months away…
Providers, lawmakers, group purchasing organizations and industry groups like the American Hospital Association have been lobbying the DEA to raise production quotas amid the shortage. In a survey of 116 member health systems, GPO and consulting group Premier found that nearly all of them are experiencing moderate-to-severe shortages of injectable opioids. More than half reported that the shortage affected patient care, including delaying or canceling surgeries or lowering patient satisfaction scores.
“We are encouraged that the DEA did transfer raw material allocations to the three other companies, and we applaud Pfizer for recognizing the need to transfer some of their excess raw material allocation to other suppliers to help meet the inpatient needs for injectable narcotics,” Todd Ebert, CEO of the Healthcare Supply Chain Association, said in an email. “However, we hope that the DEA will develop processes and procedures to recognize and respond to these market issues much more quickly in the future, as three months seems to be too long.”…
The DEA has been under immense pressure to rein in production as the opioid epidemic has worsened.
The agency reduced its production quota of opioids by at least 25% in 2016, which was the first reduction of its kind in more than two decades. But DEA-approved opioid production volumes remain high—including a 55% increase in oxycodone levels in 2017 compared with 2007, according to a July 2017 letter to the DEA signed by 16 senators…
Between 1993 and 2015, the DEA allowed production of oxycodone to increase 39-fold, along with drastic increases for other opioids, the letter said. The number of opioid prescriptions increased from 76 million in 1991 to more than 245 million prescriptions in 2014, resulting in a dramatic rise in overdoses. More than 42,000 people died from opioid overdoses in 2016, according to the Centers for Disease Control and Prevention, a five-fold increase from 1999… (H)

“Hydrocodone and oxycodone are semi-synthetic opioids, manufactured in labs with natural and synthetic ingredients. Between 2007 and 2016, the most widely prescribed opioid was hydrocodone (Vicodin). In 2016, 6.2 billion hydrocodone pills were distributed nationwide. The second most prevalent opioid was oxycodone (Percocet). In 2016, 5 billion oxycodone tablets were distributed in the United States.
The International Narcotics Control Board reported that in 2015, Americans represented about 99.7% of the world’s hydrocodone consumption.” (I)

“Governments allege that opioid companies unreasonably interfered with the public’s health by oversaturating the market with drugs and failing to implement controls against misuse and diversion, thereby creating a public nuisance.” (J)

So why didn’t manufacturers switch to a higher percentage of injectable opioids?
“Part of the issue is that there are a limited number of manufacturers that produce syringes of opioids. The products are heavily regulated given the complexity of making a syringe and the return on investment is slim.” (H)

(A) Hospitals are confronting a new opioid crisis: an alarming shortage of pain meds, by Casey Ross, https://www.statnews.com/2018/03/15/hospitals-opioid-shortage/
(B) Opioid shortages leave US hospitals scrambling, by Pauline Bartolone, https://www.cnn.com/2018/03/19/health/hospital-opioid-shortage-partner/index.html
(C) The Other Opioid Crisis: Hospital Shortages Lead To Patient Pain, Medical Errors , by Pauline Bartolone, https://www.washingtonpost.com/national/health-science/the-other-opioid-crisis-hospital-shortages-lead-to-patient-pain-medical-errors/2018/03/16/91d2c6fe-28fa-11e8-a227-fd2b009466bc_story.html?noredirect=on&utm_term=.d44201ad0fd6
(D) South Carolina hospitals dealing with ‘critical shortage’ of opioids, by Mary Katherine Wildeman, https://www.postandcourier.com/health/south-carolina-hospitals-dealing-with-critical-shortage-of-opioids/article_33c49db6-2c7a-11e8-b468-eb78b128b456.html
(E) Injectable Opioid Shortages Suggestions for Management and Conservation (Compiled by ASHP and the University of Utah Drug Information Service, March 20, 2018), https://www.ashp.org/-/media/assets/drug-shortages/docs/drug-shortages-iv-opioids-faq-march2018.ashx
(F) Drug Shortages Threaten Patient Safety, https://www.medscape.com/viewarticle/727958,
(G) Injectable opioid shortage compromises care, by Alex Kacik, http://www.modernhealthcare.com/article/20180321/TRANSFORMATION03/180329986
(H) DEA lifts production quotas to ease injectable opioid shortage, by Alex Kacik, http://www.modernhealthcare.com/article/20180414/NEWS/180419944
(I) Opioid Crisis Fast Facts, https://www.cnn.com/2017/09/18/health/opioid-crisis-fast-facts/index.html
(J) Drug Companies’ Liability for the Opioid Epidemic, by Rebecca L. Haffajee and Michelle M. Mello, http://www.nejm.org/doi/full/10.1056/NEJMp1710756

Part 1
CASE STUDY ON THE OPIOID CRISIS. “We still have lacked the insight that this is a crisis, a cataclysmic crisis”

Part 2
“In 2016, more than 40 percent of opioid overdose deaths in the U.S. involved a prescription opioid.”

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