HHS – R&R – Reachout and Rebuild

Letter from Dr. Norbert regarding COVID-19

David Posnett — Fri, 18 Sep 2020 19:10:52 +0000

COVID-19’s Human Toll, New Knowledge, Challenges Ahead

https://www.nbcboston.com/news/local/covering-coronavirus-straight-talk-on-covid-19s-death-toll/2120520/

Several of my patients have died of COVID; others hospitalized butt survived. Many more were COVID positive and for reasons that we are only beginning to understand survived with few aftereffects. Food insecurity is a new standard question whenever I speak to a patient. I’ve spoken in past COVID notes about one patient in his 30s who luckily survived weeks of intubation. While I’ve spoken to him almost on a weekly basis, I saw him for the first time only yesterday. Outwardly he looks the same. Yet he is permanently scarred – both physically and emotionally. He will likely never work again. He is undergoing rehabilitation and more procedures such as taking the filter in one of his major veins that was placed during his hospitalization for the blood clot in his leg that, in turn, was caused by COVID. Almost all my patients have an overarching sense of anxiety. I wash my hands incessantly with sanitizer; I wear a head screen over a mask whenever I am with a patient. When I come home, I undress and take a shower.

You’ve all heard about the fact that the executive branch politicized even our CDC guidelines. The vocal disagreement between the executive branch/ Republican members of Congress and scientists reached a crescendo this week with one senior HHS official taking medical leave after accusing scientists of sedition. Then executive branch leadership repeated many of the same accusations, without taking medical leave. Other challenges continue. Because we do not to date have a national COVID policy, we continue to have shortages of PPE equipment months and months after the outbreak. But the deficiencies are very solvable — “if the federal government gives the Strategic National Stockpile agency greater clout, provides it with access to better information and technology, and beefs up its expertise.” The cost of testing continues to be a challenge with individuals getting astronomical bills for COVID testing; more and more people living in the United States are going without health insurance. This in turn will have a serious impact on our health care system with the economically vulnerable among us suffering the most such as, for example, hospitals located in low income areas. This is particularly distressing as we learned this week that “Hispanic, non-Hispanic Black and non-Hispanic American Indian/Alaskan Native person accounted for 94 (78%) of the 121 deaths aged <21 years reported to the CDC.”

We are getting better at treatment of COVID 19 but have a long way to go. We are also getting better at our understanding of our bodily response. In a study with an accompanying editorial of the homogenous population of Iceland: “Whether antibodies that persist confer protection and retain neutralizing or other protective effector functions that are required to block reinfection remains unclear. Nevertheless, …the data point to the utility of antibody assays as highly cost-effective alternatives to PCR testing for population-level surveillance, which is critical to the safe reopening of cities and schools, and as biomarkers and possible effectors of immunity — useful tools…while we scan the horizon (and the pages of medical journals) for the wave of vaccines that will end the pandemic of Covid-19.”

Yet we of course realize that even with a vaccine, we will fall down yet again because we have no national policy. Though challenging, I am still using my minute leverage to encourage the National Academy of Medicine to be involved. In addition, Ask Nurses and Doctors is totally focused on the upcoming election. We are organizing health professionals in Fl, PA, and Michigan on behalf of Biden via the videos that will be circulated (Dr Abdul El-Sayed who did this video lives in Michigan and ran for governor of Michigan 2 years ago). If any of you are health professionals and would like to do a similar video – it will take no more than 10 minutes of your time. The organization AND is working for is identifying voters motivated by health care issues. Just contact me and/or spread the word. Among other activities, AND continues to work on several Congressional races from Iowa to Maine.

If you are celebrating the Jewish New Year (starts tonite!) – may it be as sweet as possible while understanding that whoever wins the White House and Congress will have many challenges. In the spirit of resolution, this is mine: which my friend Isa Aron passed on to me:

Question what is

Imagine what can be

And then do it

Lets do it together! I am lucky to know all of you.

Norbert

Labradoodle dog breeder heads HHS response to the coronavirus

David Posnett — Thu, 23 Apr 2020 17:56:29 +0000

Submitted by Peggy Backman:

Rebecca Ballhaus @rebeccaballhaus

FDA chief Stephen Hahn asked HHS (Health and Human Services) in January if he could contact companies about possible shortages of PPE and other equipment. He was told no. Azar told associates such calls would alarm the industry and make the administration look unprepared.

Health Chief’s Early Missteps Set Back Coronavirus ResponseAlex Azar, the Health and Human Services secretary, waited for weeks to brief the president, oversold his agency’s progress and didn’t effectively coordinate the health-care divisions under his purview.wsj.com

https://www.reuters.com/article/us-health-coronavirus-usa-hhschief-speci/special-report-former-labradoodle-breeder-tapped-to-lead-u-s-pandemic-task-force-idUSKCN2243CE

Letters from an American (April 22nd, 2020)

I’m going to start tonight with an important story that slipped under the radar on a day when one outrageous performance after another grabbed headlines.

On its surface, the story doesn’t seem terribly important. A number of congressional committees have asked the Office of Personnel Management for updates on how the OPM is handling working conditions for federal employees during the coronavirus crisis. OPM is declining to answer the requests. “It has always been difficult to get information from this administration, but the refusal to provide Congress with a basic briefing during a pandemic is especially egregious,” said a Democratic Senate aide to Politico reporter Daniel Lippman. “We’ve never been denied a briefing like this before.”

But the story is actually very significant. The OPM oversees the 2 million workers in the federal government. In mid-February, after Republican Senators acquitted him in his impeachment trial, Trump set out to purge the federal workforce of civil servants, whom he sees as “snakes,” and replace them with political appointees loyal to him.

To head the Presidential Personnel Office, which recruits candidates for the executive branch, Trump brought in John McEntee, who had been fired from a former position in the White House by former chief of staff, John Kelly, over a security clearance. On March 17, McEntee forced the director of the Office of Personnel Management, Dale Cabaniss, who had significant personnel experience, to resign. Michael Rigas, formerly of the right-wing Heritage Foundation, took his place. (Phew. I know… but this is going somewhere important.)

The change from Cabaniss to Rigas at the head of OPM transpired just as the novel coronavirus pandemic hit the nation hard.

Rigas has said he believes the 1883 Pendleton Act is unconstitutional. Congress passed the Pendleton Act, also known as the Civil Service Act, after a mentally-ill office seeker shot President James Garfield in 1881. Until then, government positions had been handed out to political loyalists, regardless of their capacity to do the job, but the assassination created a public outcry. Charles Guiteau shot Garfield with the expectation that, once elevated to the presidency, Garfield’s vice president would give Guiteau the position his delusions made him think he deserved. The assassination built momentum behind the idea that government should be non-partisan, and that positions should be filled by people actually equipped to do the job. This sentiment has ruled the nation ever since.

Non-partisan civil service has proved a blessing to the nation in two ways. First of all, over time, as more and more positions came under the act, the government got much more efficient. Second, a non-partisan corps of officials has kept the nation stable since they give their loyalty to the country’s government, rather than to any particular president. Administrations come and go, but government bureaucrats keep the nation on an even keel.

Now, Rigas, the man at the head of the federal government’s 2 million workers, wants to get rid of that system and make all employees of the executive branch political appointees, loyal not to the country but to Trump. Rigas is working with McEntee at the PPO. As of a few weeks ago, agencies now have to submit job openings to the PPO to see if they have anyone they want in the position before they can submit their own choice for it. PPO is filling positions with keen regard for their loyalty: recently it has hired four college seniors to become administration officials.

OPM is the office that is refusing to tell Congress what it’s up to.

Today offered some guesses. Dr. Rick Bright, the director of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, claimed that he was let go from his job for crossing Trump. BARDA is charged with protecting us from pandemic influenza and emerging infectious diseases (EID) and Bright is a specialist in those areas. He headed the federal agency developing a coronavirus vaccine, and refused to use the agency’s significant budget to promote hydroxychloroquine, the anti-malarial drug Trump has been pushing as a treatment for the coronavirus. Bright was transferred to a less central position at the National Institutes of Health, but has refused to resign his position at BARDA.

Bright and his lawyers say his removal is retaliation and that he will be filing a whistleblower complaint. “I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the Covid-19 pandemic into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit,” he said in a statement. “I am speaking out because to combat this deadly virus, science — not politics or cronyism — has to lead the way.”

Bright’s defense of science over politics got a boost with Tuesday’s news that hydroxychloroquine is not only ineffective against Covid-19, but possibly worsens the outcome for those who take it. A study of 368 patients at Veterans Affairs showed that those given the drug were more likely to die than those who weren’t. After much hyping of the drug, Laura Ingraham and other Fox News Channel personalities have suddenly gone quiet on it. Trump, who hailed the drug as a “game-changer” but who has stopped talking about it lately, said he did not know of the bad report, “but we’ll be looking at it.”

Demanding loyalty to Trump is about cementing the power of the president, and service to that power means he will sacrifice his loyalists whenever necessary to protect himself. People are noting that Trump tossed Georgia Governor Brian Kemp under the bus today over Kemp’s reopening of certain Georgia businesses against the advice of public health officials. After a week of calling for states to reopen, Trump told reporters that he “disagree[s] strongly” with Kemp’s decision to start that process.

But Kemp and Trump have clashed before—Trump wanted Kemp to appoint key Trump supporter Doug Collins to the Senate seat that Kemp gave to Kelly Loeffler (now in trouble for insider trading)—so it’s not a huge surprise that Trump hung Kemp out to dry.

Today’s more significant underbussing was that of Alex Azar, the secretary of the Department of Health and Human Services, who was skewered in a piece in the Wall Street Journal for what appears to have been extraordinarily inept handling of the coronavirus crisis. My guess is that he is shortly going to be out of a job, taking the blame for the White House’s poor response to the pandemic.

Considering that Trump’s OPM wants to remove qualified civil servants from the government in favor of political cronies, the piece of the Azar story that has attracted the most outrage is ironic. Azar tapped a key aide with little experience or education in public health, management, or medicine to head up the response of Health and Human Services to the coronavirus crisis.

Before going to work for Azar, the aide, Brian Harrison, was a dog breeder who specialized in labradoodles.

Notes:

McEntee: https://www.axios.com/johnny-mcentee-white-house-d1c29eee-8b0a-4c4d-8ba4-9355f3c27f4f.html

Cabaniss resigns: https://www.politico.com/news/2020/03/17/opm-chief-resigns-134541

PPO and OPM: https://www.politico.com/news/2020/04/21/democrats-blast-trump-federal-workers-coronavirus-199026

Bright: https://www.nytimes.com/2020/04/22/us/coronavirus-live-coverage.html

https://www.nytimes.com/aponline/2020/04/22/business/ap-us-virus-outbreak-hhs-whistleblower.html

https://www.cnn.com/2020/04/22/politics/rick-bright-barda-trump-coronavirus/index.html

https://www.thedailybeast.com/study-of-hydroxychloroquine-trump-promoted-coronavirus-drug-finds-more-deaths

https://www.nytimes.com/2020/04/22/business/media/virus-fox-news-hydroxychloroquine.html

Kemp: https://www.nbcnews.com/politics/donald-trump/trump-reverses-course-says-too-soon-georgia-reopen-n1190061

https://www.politico.com/news/2020/04/22/trump-kemp-georgia-reopen-coronavirus-202117

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Trump Undercuts ACA with New Plan Options

David Posnett — Thu, 19 Oct 2017 18:12:36 +0000

Author Shannon Muchmore @stmuchmore

Published Oct. 12, 2017

Dive Brief:

President Donald Trump signed an executive order Thursday that rolls back a number of Affordable Care Act (ACA) provisions that set minimum requirements for health plans.
The order will allow small businesses and groups of people to band together and buy insurance as an association. The association health plans (AHP) available to them do not have to meet the requirements of the ACA, such as protection for people with pre-existing conditions and essential health benefits.
In addition, the order expands the use of short-term plans that also have looser requirements and allows plans to be sold across state lines.

Dive Insight:

Broadly, the executive order loosens the requirements health plans must meet and shifts regulation away from federal levels. This could lower out-of-pocket costs for people who don’t use much care, but would likely result in major cost increases for people with pre-existing conditions.

The biggest concern with offering these plans is that it would lead payers to cherry pick young, healthy people who are less expensive for payers. But separating them from people who will need services creates an unbalanced risk pool. That can quickly lead to prohibitive out-of-pocket costs for people who have a pre-existing condition or who unexpectedly need high-cost care.

There are still several steps to be taken before the order could have a real impact. HHS and the Department of Labor have been instructed to write new regulations which will go through the regular notice and comment process. The specifics of those regulations will be important to how the order ultimately plays out. Also, the order will almost certainly see a legal challenge. Still, it signals that Trump’s White House is ready to find ways of undercutting the ACA despite the high-profile legislative failures earlier this year.

It’s far from the first sign, though. HHS has drastically cut back efforts to promote this year’s open enrollment period, which begins Nov. 1. The ACA’s overall advertising budget was slashed by 90%, community groups that receive federal funding to help people enroll have been devastated by cuts and HHS recently barred regional directors from participating in enrollment events.

Short-term plans are inexpensive for people who are healthy, but they can exclude people with pre-existing conditions. They have previously been allowed for a limited stretch, such as three months, but extending that time and allowing these plans to count toward the individual mandate will mean an unstable risk pool.

Allowing plans to be sold across state lines is a staple of conservative health policy, but there is little reason to believe it would actually lower costs. There are also many unanswered questions about how these plans would be relegated.

Tom Price Must Go

David Posnett — Fri, 29 Sep 2017 20:24:19 +0000

Posted on their website where you can also sign up in support. Here is the message from the National Physician’s Alliance:

We’ve been here before. Almost a year ago, we opposed the nomination of Dr. Tom Price for Secretary of Health and Human Services. As clinicians who put our patients first, today we call for Tom Price to resign.

A year ago, we were concerned that Dr. Price did not have a record of promoting policies that prioritized Americans’ health. As a legislator in the House of Representatives, he supported dismantling Medicaid, reducing funding for the Children’s Health Insurance Program (CHIP), and removing essential health benefits that would provide access to treatment for opioid use disorders, prenatal care, and contraception.

Prior to his confirmation, we learned that Dr. Price had traded stocks that stood to profit from his direct actions in the legislature, raising serious questions around his ethical conduct.

Regrettably, his tenure has only confirmed our fears.

In his confirmation hearings, Secretary Price recalled the lessons he learned as a practicing physician. One lesson he highlighted was that “many patients [he] knew or treated were never more angry and frustrated than when they realized that there was someone other than themselves and/or their physician making medical decisions on their behalf – when there was someone not involved in the actual delivery of care that was standing between them and their doctor or treatment.”

However, as Secretary of Health and Human Services (HHS) – that is precisely where Dr. Price has found himself: directly impeding patients’ ability to access treatment.

Worse, he has shirked his duties in office and wasted taxpayer dollars in the process.

His brazen decision to misspend over $400,000 by traveling needlessly on private jets is only the most recent offense to come to light. Records indicate that he used public funding to travel to luxury resorts, areas where he owned property, speaking events for friends, and lunch with his son. New reporting2 puts his travel costs at over $1 million in just 8 months; his recent decision to pay back only $52,000 of these costs only highlights his lack of accountability.

Beyond these questionable ethics, Dr. Price has eagerly advocated for legislation that would increase cost of health insurance and reduce access to care. These policies, according to multiple Congressional Budget Office (CBO) estimates, would create anywhere from 20 to 32 million additional uninsured and were universally opposed by patient groups, doctors, nurses, hospitals, health systems, and insurers.

During this process, he provided at best, misinformation, and at worst, outright lies about the impact of the legislation he was promoting.

Most egregiously, Dr. Price has demonstrated dereliction of his duties at HHS, which has been used as a political tool for sabotage of the Affordable Care Act (ACA), rather than as an institution for policy implementation. Under his leadership, HHS has used funding that was earmarked to increase enrollment to run ads against the ACA. The ACA enrollment period has been reduced by 45 days; television advertising and patient navigators have been cut; and access to the health insurance portal has been reduced with unnecessary periods of website shutdown.

The uncertainty he has created over continuing the cost-sharing reduction payments mandated under law has only served to destabilize the insurance markets and increase premiums for patients.

Tom Price should never have been confirmed. His conduct prioritizes self-enrichment, and raises critical questions about his commitment to “improve the lives of the American people, to help heal individuals and whole communities.” He has advocated cuts to programs impacting the most vulnerable Americans, while simultaneously wasting taxpayer resources. Now almost one year later, we believe that his actions in office warrant resignation.

It’s time for Tom Price to go.

Tom Price Bought Drug Stocks. Then He Pushed Pharma’s Agenda in Australia.

David Posnett — Thu, 01 Jun 2017 21:26:12 +0000

Before he was named Trump’s health secretary, Price took a congressional trip to Australia and pressed officials to extend protections for drug companies in an international trade agreement.

by Robert Faturechi
ProPublica, June 1, 2017, 8 a.m.

In the spring before the 2016 presidential election, the Obama administration’s 12-nation trade agreement known as the Trans-Pacific Partnership, or TPP, was still alive. Negotiators worked on details as Congress considered whether to ratify the pact.

The Australian government was getting in the way of one change demanded by U.S. pharmaceutical companies. Makers of cutting-edge biological drugs wanted to have data from their clinical trials protected from competitors for 12 years, as they are under U.S. law — not the roughly five years permitted under the TPP. Australian officials insisted that an extension would deprive consumers of cheaper alternatives for too long.

On April 5, 2016, a bipartisan group of U.S. lawmakers arrived in Canberra, Australia’s capital, for meetings with government officials on a broad range of subjects. Among those on the routine congressional trip was Rep. Tom Price, a Georgia Republican who would go on to become President Trump’s secretary of health and human services. Three weeks before the trip, Price had purchased up to $90,000 worth of pharmaceutical stocks — trades that would come under scrutiny after his nomination to Trump’s cabinet.

In Canberra, Price and another Republican, Rep. John Kline of Minnesota, pressured senior Australian trade officials to modify their position on the 12-year extension, according to a congressional aide who was on the trip. The Australians explained that they had no intention of changing their laws or rules in ways that could increase drug prices. Price and Kline continued pushing, according to the aide, asking for a side letter or other written guidance that the period would be extended in Australia even if it weren’t spelled out in the TPP itself.

Price’s lobbying abroad, which has not previously been reported, is another example of how his work in Congress could have benefitted his investment portfolio. He traded hundreds of thousands of dollars’ worth of shares in health-related companies while taking action on legislation and regulations affecting the industry. ProPublica previously reported that Price’s stock trades are said to be under investigation by federal prosecutors.

Price, who did not respond to an interview request for this story, has said he did nothing wrong, that his broker generally chose stocks without his knowledge and that all of his trades were publicly disclosed.

Price’s financial disclosures submitted to the House Office of the Clerk show that on March 17, 2016, he purchased shares worth between $1,000 and $15,000 each in Eli Lilly, Amgen, Bristol-Meyers Squibb, McKesson, Pfizer and Biogen. All six companies had an interest in biological drugs, which are grown from live cells and are known for short as biologics. Eli Lilly, for example, is behind Portrazza, the first biologic approved to treat a common type of lung cancer. Amgen makes a top-seller for rheumatoid arthritis and psoriasis. Biogen developed a biologic for people suffering multiple sclerosis relapses.

Kline, who has since retired from Congress, said he could not recall if he or anyone else raised the biologics issue. His financial disclosures do not show direct holdings in pharmaceutical companies.

Australia has played another role in Price’s financial activities. In 2015 the congressman bought about $10,000 worth of shares in Innate Immunotherapeutics, a small biologics firm with an office in Sydney. After the congressional trip, which also made a stop in Sydney, Price purchased a larger stake in the company, about $84,000 worth, in two private placements, the first of which was announced in June. Price was invited to purchase the shares at a discounted rate.

It’s not known if Price had any contact with the firm while in Sydney. Price didn’t respond to questions about when and where he discussed the discounted offering with company officials. The company’s officials also did not respond.

Traveling congressional delegations typically meet with a variety of local officials, and at the time of the visit to Australia it wasn’t unusual for Republican lawmakers to side with the pharmaceutical industry on the trade deal’s protections for biologics. Price’s advocacy stands out because he pushed the cause directly with foreign officials, while at the same time owning stakes in companies that could have benefited.

An itinerary for the trip reviewed by ProPublica mentions TPP in relation to one of the meetings, but does not list the biologics provision. A former Australian trade official, who asked not to be named and attended one of the meetings, confirmed that the 12-year lockup was addressed, but said he could not recall which Congress members were pushing it.

Others on the trip, organized by the House’s Education and the Workforce Committee, were Robert Scott, D-Va., Ruben Hinojosa, D-Texas, Erik Paulsen, R-Minn. and Dan Benishek, R-Mich. Those members who responded to requests for comment said they could not recall whether the provision was discussed.

The data collected during clinical trials of drugs can save competitors time in developing the cheaper alternatives to biologics known as biosimilars. Keeping the data proprietary longer extends the original drugmaker’s monopoly. While some big brand-name pharmaceutical companies also make biosimilars, they and their trade association — the Pharmaceutical Research and Manufacturers of America — advocated strongly for longer exclusivity.

In the end, the debate over the provision became moot. Trump scrapped the TPP days after taking office. Price divested his drug stocks upon taking the cabinet post. His investment in Innate Immunotherapeutics yielded a profit of at least $150,000.