Research shows that those who are immunosuppressed are at higher risk of becoming severely ill from COVID.

This article was published on Friday, August 13, 2021 in Kaiser Health News.

By Victoria Knight  

Elizabeth Groenweghe got a kidney transplant 14 years ago. She now takes several medications to prevent her body from rejecting her transplant organ. But these medications also weaken her immune system, putting her at higher risk of becoming seriously ill if she catches COVID-19.

When the pandemic began last year, Groenweghe, 29, worked from home for the first month and a half. But then in May 2020, as the chief epidemiologist for the public health department in Wyandotte County, Kansas, she returned to the office.

"Obviously, I was nervous about it because I'm so immunosuppressed," said Groenweghe.

She felt relatively safe because her co-workers wore masks and strictly followed infection control protocols. But now that vaccinations have become widely available, her workplace has stopped requiring or enforcing mask use. There is no vaccine mandate for her office, and she knows some co-workers are unvaccinated. She feels uncomfortable working around them.

"I am debating putting a sign on my door that says 'Please do not enter if you are unvaccinated,' because I am really concerned about getting COVID … and have even had a couple co-workers test positive recently," said Groenweghe.

"Knowing that I don't have any protection against COVID, I'm still wearing a mask and I'm trying to avoid in-person meetings," she added. "It has been frustrating because, at home, my bubble of protection is great; all of my family and friends are vaccinated. At work I don't have as much control."Bottom of Form

While the emergence of the delta variant in the U.S. has made many companies delay the return to in-person work or mandate vaccinations, in other offices, immunosuppressed people like Groenweghe are left to cobble together their own strategies to minimize their risks. The delta variant raises the stakes for many who were already concerned about catching COVID when they return. Those who have the option to keep working remotely have done so — but worry about what it means for their careers as their colleagues return to the workplace.

Research showing how well vaccines protect those with weakened immune systems is limited. In part that's because immunosuppressed people, who make up at least 3% of the U.S. population and include people with cancer, HIV and many chronic health conditions, were not included in the original clinical trials for the three COVID vaccines authorized for emergency use.

Scientists didn't include them because they needed to conduct the clinical trials quickly and were concerned that this group's immunosuppressive medicines and increased likelihood of developing infections in general would complicate interpreting the study results.

Research does show that those who are immunosuppressed are at higher risk of becoming severely ill from COVID, passing the virus to others in their household and getting infected even if vaccinated. A recent study reported that 44% of hospitalized "breakthrough" cases in the U.S. were in immunosuppressed people.

Concerns about her elevated COVID risk led Groenweghe to obtain a third dose of the Moderna vaccine on her own — and participate in a Johns Hopkins University research study that involved measuring transplant recipients' immune response to an extra vaccine dose. Hopkins recently told her she hadn't produced any antibodies.

But, while the third dose might not have helped Groenweghe, early research shows that a booster shot seems to strengthen the immune response for some with weakened immune systems. Israel began distributing additional doses to the immunosuppressed in July. Britain and France have said they plan to start distributing booster doses to high-risk groups in September. However, the World Health Organization recently called for a moratorium on booster shots until more vaccine could be distributed globally to countries with low vaccination rates.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a July Senate hearing that immunosuppressed people "may actually need a boost as part of their initial regimen in the sense of getting them up to the point where they are protected."

And soon, third doses may indeed become part of the regimen. The Food and Drug Administration reportedly is closing in on amending the emergency use authorization requests for the Pfizer-BioNTech and Moderna vaccines to allow third doses of those shots to be given to those with weakened immune systems. The vaccine advisory committee of the Centers for Disease Control and Prevention was set to meet Friday and is expected to vote on whether to officially recommend that doctors can prescribe third doses to immunocompromised people. Still, federal officials said these third doses would be recommended only for a small number of immunocompromised people, and it's not yet clear who will be included.

Well in advance of this green light, patients were asking their doctors about additional shots.

Andrew Clifford is one such patient. (KHN is identifying him by his first and middle names because he fears retaliation from his workplace.) Andrew, a marketing manager from Missouri, is working from home indefinitely and worries about what he might be missing. The 40-year-old has multiple sclerosis and takes immunosuppressive medication.

"The fear of missing out is a tremendous anxiety," he said. Recently his entire team went back to the office for two weeks to meet with an outside agency. While Andrew was able to go in for two days, he could tell he had missed out on things on the days he stayed home.

"I missed out on the lunchtime convos. When I did show up in the Zoom meetings, I was playing a lot of catch-up," he said. "I was trying to figure out who I was actually talking to and what they did."

Some patients, such as transplant recipient Elyse Thomas, aren't waiting for new guidance from the U.S. government. (KHN is identifying her by her middle and last names because she is worried about pushback from her employer.) Instead, Elyse, a 30-year-old social worker for a high school district in the Bay Area of California, pursued third and fourth doses of a COVID vaccine on her own since her school district had staff members return in person in early August.

"Some of us transplant patients have had to take matters into our own hands," Thomas said. "We can't wait for the recommendation while we could be dying."

She asked for an accommodation to continue working remotely during the 2021-22 school year, as she did the year before, but was told all employees must return. Thomas was offered the option to take medical leave without pay if she didn't want to come into the office, but that would strain her finances. Her workplace does have a mask mandate, but she's not sure physical distancing will be enforced and she's even more anxious now that the delta variant is circulating.

"I don't feel safe and I don't understand why I have to be there in person," Thomas said. "I don't want to risk my transplant for a paycheck. I don't want to risk my life for a paycheck."

Victoria Knight: vknight@kff.org, @victoriaregisk

From Fresno, California, to Portland, Maine, universities, communities and businesses are monitoring human excrement for signs of COVID.

This article was published on Monday, August 16, 2021 in Kaiser Health News.

By Anna Maria Barry-Jester

Since reopening campus at the University of California-San Diego last summer, university officials have relied on the tried-and-true public health strategies of testing and contact tracing. But they have also added a new tool to their arsenal: excrement.

That tool alerted researchers to about 85% of cases in dorms before they were diagnosed, according to a soon-to-be published study, said Rob Knight, a professor of pediatrics and computer science and engineering who helped create the campus's wastewater testing program.

When COVID is detected in sewage, students, staffers and faculty members are tested, which has allowed the school to identify and isolate infected individuals who aren't yet showing symptoms — potentially stopping outbreaks in their tracks.

UC-San Diego's testing program is among hundreds of efforts around California and the nation to turn waste into valuable health data. From Fresno, California, to Portland, Maine, universities, communities and businesses are monitoring human excrement for signs of COVID.

Researchers have high hopes for this sludgy new data stream, which they say can alert public health officials to trends in infections and doesn't depend on individuals getting tested. And because people excrete virus in feces before they show symptoms, it can serve as an early warning system for outbreaks.

The Centers for Disease Control and Prevention finds the practice so promising that it has created a federal database of wastewater samples, transforming raw data into valuable information for local health departments. The program is essentially creating a public health tool in real time, experts say, one that could have a range of uses beyond the current global pandemic, including tracking other infectious diseases and germs' resistance to antibiotics.

"We think this can really provide valuable data, not just for COVID, but for a lot of diseases," said Amy Kirby, a microbiologist leading the CDC effort.

The virus that causes COVID infects many types of cells in the body, including those in the respiratory tract and gut. The virus's genetic signature, viral RNA, makes its way into feces, and typically shows up in poop days before symptoms start.

At UC-San Diego and other campuses, researchers take samples flowing from individual buildings, capturing such granular data that they can often deduce the number of infected people living or working there. But in most other settings, because of privacy concerns and resource constraints, testing is done on a much larger scale, with the goal of tracking trends over time.

Samples are drawn from wastewater, which is what comes out of our sewer pipes, or sludge, the solids that have settled out of the wastewater. They are typically extracted mechanically or by a human with a dipper on the end of a rod.

When researchers in Davis, California, saw the viral load rise in several neighborhood sewage streams in July, they sent out text message alerts and hung signs on the doors of 3,000 homes recommending that people get tested.

Before the pandemic, testing sewage to identify and ward off illness in the U.S. was largely limited to academic use. Israel used it to stave off a polio outbreak in 2013, and some communities in the U.S. were sampling sewage before the pandemic to figure out what kinds of opioids people in their communities were using, a service offered by the company Biobot.

But when COVID hit the U.S. amid political chaos and a shortage of tests, local governments scrambled for any information they could get on the virus.

In rural Lake County, California, health officials had identified a handful of cases by sending nurses out to look for infected people. They were sure there were more but couldn't get their hands on tests to prove it, so in spring 2020 they signed up for a free sewage testing program run by Biobot, which pivoted to COVID testing as the pandemic took off and now is charging to test in K-12 schools, office buildings and nursing homes, in addition to local governments and universities, said Mariana Matus, CEO and co-founder of the company.

The COVID virus turned up in samples at four wastewater treatment facilities in Lake County.

"It is a way to just get more information because we can't do testing," Gary Pace, then the county's health officer, told KHN at the time.

As sewage sampling took off around the world, the U.S. Department of Health and Human Services began awarding grants in fall 2020 to wastewater treatment plants. Biobot won a bid to run a second round of that program, currently underway through late August, testing the sewage of up to 30% of the U.S. population.

At least 25 California wastewater treatment plants are participating in the program, and numerous others are getting money from the CDC, working with local universities or paying for their own testing. While such states as Ohio and Missouri have created public dashboards to show their data, California's efforts remain scattershot.

The test data alone doesn't provide much value to health officials — it needs to be translated to be useful. Scientists are still learning how to read the data, a complicated process that involves understanding the relationships between how much virus people excrete, how many people are using a wastewater system and how much rainwater is running into the system, potentially diluting the sewage, among many other factors. Since using wastewater to track diseases was not widespread before the pandemic, there's been a steep and ongoing learning curve.

Beleaguered public health officials have struggled to incorporate the new data into their already overwhelming workloads, but the CDC hopes it can address those issues with its new national system that tracks and translates wastewater data for local governments.

Throughout 2020, Kirby, the CDC microbiologist, and engineer Mia Mattioli were a two-person wastewater team inside the agency's larger 7,000-person COVID response. During that time, academic colleagues generously shared what they knew about wastewater epidemiology, Kirby said. By September 2020, the pair had launched the National Wastewater Surveillance System, which interprets sampling data for state and local governments. Today, they lead a team of six and have a permanent place in one of the CDC's departments.

"Every piece of this system had to be built largely from scratch," Kirby said. "When I look at that, it really amazes me where we are now."

In the months since the system debuted, it has been able to detect an uptick in cases anywhere from four to six days before diagnostic testing shows an increase, Kirby said.

She hopes that by the end of next year the federal monitoring program will be used to check for a range of diseases, including E. coli, salmonella, norovirus and a deadly drug-resistant fungus called Candida auris, which has become a global threat and wreaked havoc in hospitals and nursing homes.

The longer these programs are up and running, the more useful they become, said Colleen Naughton, a professor and civil engineer at the University of California-Merced who leads COVIDPoops19, which tracks wastewater monitoring efforts globally. Naughton is working with colleagues at the University of California-Davis to launch monitoring programs near where she works in the Central Valley but is finding that some smaller communities don't have the resources to conduct testing or sufficient health personnel to analyze or use the data.

It's in these smaller communities with limited access to testing and doctors where the practice may hold the most promise, Naughton said. COVID laid bare long-standing inequities among communities that she fears will be perpetuated by the use of this new public health tool.

Privacy concerns also need to be addressed, experts said. Wastewater data hasn't traditionally been considered protected personal health information the way diagnostic tests are. Health officials have managed earlier concerns about wastewater tracking of illicit drug use by sampling from large enough sewage streams to offer anonymity. But testing for certain health problems requires looking at DNA. "I think that's going to be a challenge for public communication," Knight said, "to make sure that's not perceived as essentially spying on every individual's genetic secrets."

Public health and wastewater officials said they are thrilled by the potential of this new tool and are working on ways to address privacy concerns while taking advantage of it. Greg Kester, director of renewable resource programs at the California Association of Sanitation Agencies, wrote to CDC officials in June 2020 asking for a federal surveillance network. He can hardly believe how quickly that call became a reality. And he hopes it is here to stay, both for the ongoing pandemic and for the inevitable next outbreak.

"As vaccination rates increase and we get the variants, it's still going to be important because clinical testing is decreasing," Kester said. "We really want to make this part of the infrastructure."

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

Anna Maria Barry-Jester: annab@kff.org, @annabarryjester

 

From California to Massachusetts, veterans have been active in the push for medical marijuana legalization for decades.

This article was published on Friday, August 13, 2021 in Kaiser Health News.

By Aneri Pattani

RALEIGH, N.C. — Each time Chayse Roth drives home to North Carolina, he notices the highway welcome signs that declare: "Nation's Most Military Friendly State."

"That's a powerful thing to claim," said Roth, a former Marine Corps gunnery sergeant who served multiple deployments to Iraq, Afghanistan and Pakistan.

Now he says he's calling on the state to live up to those words. A Wilmington resident, Roth is advocating for lawmakers to pass a bill that would legalize medical marijuana and allow veterans with post-traumatic stress disorder and other debilitating conditions to use it for treatment.

"I've lost more men to suicide since we went to Afghanistan in '01 than I have in combat," said Roth, who said he doesn't use cannabis himself but wants others to have the option. "It's just unacceptable for these guys to go overseas and win the battle and come home and lose the battle to themselves."

He is among several veterans brought together by a recently formed advocacy group called NC Families for Medical Cannabis. These veterans have testified before the legislature and visited lawmakers individually.

In a state that's home to eight military bases, one of the largest veteran populations in the country and a Republican-controlled legislature that prides itself on supporting the troops, they hope their voices will act as a crucial lever to push through a bill that has faced opposition in the past.

"If we really want to be the most veteran-friendly state in the union, this is just another thing we can do to solidify that statement," Roth said.

From California to Massachusetts, veterans have been active in the push for medical marijuana legalization for decades. But now, as the movement focuses on the remaining 14 states that have not enacted comprehensive medical marijuana programs or full marijuana legalization, their voices may have outsize influence, experts say.

Many of these remaining states are in the traditionally conservative South and dominated by Republican legislatures. "The group carrying the message here makes a huge difference," said Julius Hobson Jr., a former lobbyist for the American Medical Association who now teaches lobbying at George Washington University. "When you've got veterans coming in advocating for that, and they're considered to be a more conservative bunch of folks, that has more impact."

Veterans also have the power of numbers in many of these states, Hobson said. "That's what gives them clout."

Successes are already evident. In Texas and Louisiana, veterans played a key role in the recent expansion of medical marijuana programs. In Mississippi, they supported a successful ballot initiative for medical cannabis in 2020, though the result was later overturned by the state Supreme Court. And in Alabama, the case of an out-of-state veteran arrested and jailed for possession of medical marijuana incited national outrage and calls for legalization. The state legalized medical marijuana earlier this year.

To be sure, not every veteran supports these efforts, and the developments in red states have been influenced by other factors: advocacy from cancer patients and parents whose children have epilepsy, lawmakers who see this as a states' rights issue, a search for alternative pain relief amid the opioid epidemic and a push from industries seeking economic gains.

But the attention to the addiction and suicide epidemics among veterans, and calls to give them more treatment options, are also powerful forces.

In states like North Carolina, where statewide ballot initiatives are banned, veterans can kick-start a conversation with lawmakers who hold the power to make change, said Garrett Perdue, the son of former North Carolina Gov. Beverly Perdue and a spokesperson for NC Families for Medical Cannabis and CEO of Root Bioscience, a company that makes hemp products.

"It fits right in with the general assembly's historical support of those communities," Perdue said. "For [lawmakers] to hear stories of those people that are trusted to protect us and enforce the right of law" and see them as advocates for this policy "is pretty compelling."

Gary Hess, a Marine Corps veteran from Louisiana, said he first realized the power of his platform in 2019, when he testified in front of the state legislature about seeing friends decapitated by explosions, reliving the trauma day-to-day, taking a cocktail of prescription medications that did little to help his symptoms and finally finding relief with cannabis. His story resonated with lawmakers who had served in the military themselves, Hess said.

He recalled one former colonel serving in the Louisiana House telling him: "They're not going to say no to a veteran because of the crisis you're all in. As someone who is put together well and can tell the story of marijuana's efficacy, you have a powerful platform."

Hess has since started his own nonprofit to advocate for medical marijuana legalization and has traveled to other state and national events, including hearings before the North Carolina legislature.

"Once I saw the power my story had," he said, "the goal became: How do I expedite this process for others?"

Experts trace the push for medical marijuana legalization back to the AIDS epidemic of the 1980s and '90s, particularly in California's Bay Area.

As the movement tried to expand, medical marijuana activists realized other regions were not as sympathetic to the LGBTQ community, said Lee Hannah, an associate professor of political science at Wright State University who is writing a book about the rise of legal marijuana in the U.S. They had to find "more target populations that evoke sympathy, understanding and support," Hannah said.

Over time, the medical marijuana conversation grew from providing symptom relief for patients with AIDS to include such conditions as cancer, pediatric epilepsy and PTSD, Hannah and his colleagues noted in a 2020 research paper. With each condition added, the movement gained wider appeal.

"It helped change the view of who a marijuana user is," said Daniel Mallinson, a co-author on the 2020 paper and the upcoming book with Hannah, and an assistant professor at the Penn State-Harrisburg School of Public Affairs. "That makes it more palatable in these legislatures where it wouldn't have been before."

In 2009, New Mexico became the first state to make PTSD patients eligible for medical marijuana. The condition has since been included in most state medical marijuana programs.

The movement got another boost in 2016 when the American Legion, a veterans organization with 1.8 million members known for its conservative politics, urged Congress to remove marijuana from its list of prohibited drugs and allow research into its medical uses.

"I think knowing an organization like the American Legion supports it frankly gives [lawmakers] a little bit of political cover to do something that they may have all along supported but had concerns about voter reaction," said Lawrence Montreuil, the group's legislative director.

In Texas, when the Republican governor recently approved a law expanding the state's limited medical marijuana program, he tweeted: "Veterans could qualify for medical marijuana under new law. I will sign it."

It's smart political messaging, Hannah said. Elected officials "are always looking to paint laws they support in the most positive light, and the approval rate of veterans is universally high."

Nationally, veteran-related marijuana bills seem to be among the few cannabis-related reforms that have gained bipartisan support. Bills with Democratic and Republican co-sponsors in Congress this session deal with promoting research into medical marijuana treatment for veterans, allowing Veterans Affairs doctors to discuss cannabis with patients in states where it is legal and protecting veterans from federal penalization for using state-legalized cannabis.

Rep. Dave Joyce (R-Ohio), who has co-sponsored two bipartisan bills concerning veterans and medical marijuana this session, said the interest of veterans is "what drew me to cannabis in the first place."

In North Carolina, veterans like Roth and Hess, along with various advocacy groups, continue to drum up support for the medical marijuana bill. They know it's a long battle. The bill must clear several Senate committees, a full Senate vote and then repeat the process in the House. But Roth said he's optimistic "the veteran aspect of it will be heavily considered by lawmakers."

An early indication of that came at a Senate committee hearing earlier this summer. Standing at the podium, Roth scrolled through his phone to show lawmakers how many of his veteran contacts were now dead due to suicide. Other veterans testified about the times they had contemplated suicide and how the dozens of prescription medications they had tried before cannabis had done little to quiet those thoughts.

The hearing room was silent as each person spoke. At the end, the lawmakers stood and gave a round of applause "for those veterans who are with us today and those who are not."

The bill later passed that committee with a nearly unanimous vote.

Aneri Pattani: apattani@kff.org, @aneripattani

A KHN review of treasurer reports from 2015 through 2020 shows that pharmaceutical companies have given consistently to the national academies.

This article was published on Thursday, August 12, 2021 in Kaiser Health News.

By Christina Jewett August 12, 2021

To several U.S. senators, it looked wasteful, even outrageous. Every year, taxpayers pay for at least $750 million worth of expensive pharmaceuticals that are simply thrown away. Companies ship many of the drugs in "Costco"-size vials, one lawmaker said, that once opened usually cannot be resealed or saved for other patients. Yet pharma gets paid for every drop.

So Congress turned to the prestigious National Academies of Sciences, Engineering and Medicine for advice, given its reputation for "independent, objective reports" on such matters. The national academies' influential report, released in February, struck physicians who've tracked the issue as distinctly friendly to Big Pharma. It advised against an effort to recoup millions for the discarded drugs. It concluded that Medicare should stop tracking the cost of the drug waste altogether.

Yet the report left out a few key facts, a KHN investigation has found.

Among them: One committee member was paid $1.4 million to serve on the board of a pharmaceutical corporation in 2019 and in 2020 joined the board of a biotechnology company that lists government "cost containment" efforts as a risk to its bottom line.

Another committee member reported consulting income from 11 to 13 pharmaceutical companies, including eight that Medicare records show have earned millions billing for drug waste. His pharma ties were disclosed in unrelated publications in 2019 through this year.

Those committee members said they reported relevant relationships to the national academies and that the information is readily available outside of the report.

What's more: The National Academy of Sciences itself for years has been collecting generous gifts from foundations, universities and corporations, including at least $10 million from major drugmakers since 2015, its treasurer reports show. Among the donors are companies with millions to retain or lose over the drug waste committee's findings.

The fact that those relationships were not disclosed in the final report by an organization charted in 1863 to advise the nation amounts to "egregious" failures, said Sheldon Krimsky, a Tufts University professor and expert on conflicts of interest in science.

"The amount of money you're reporting is really substantial," he said. "It really raises questions about the independence" of the national academies.

In a statement emailed to KHN, the national academies said the two members with undisclosed board and consulting roles had "no current conflicts of interest during the time the [drug waste] study was being conducted" from January 2020 through February. The report did disclose conflicts for two others on the 14-member board. The report in question was paid for by federal officials, and "funds from for-profit organizations with a direct financial interest in the outcome of a study may not be used to fund advisory consensus studies, except in rare circumstances," national academies spokesperson Dana Korsen said in the emailed statement.

She also said the organization is implementing a new conflict-of-interest policy that will be fully in place this fall.

"Protecting the integrity, independence, and objectivity of our study process is of the utmost importance to the National Academies," her statement said.

The committee's failure to call for concrete changes — and the millions in gifts from pharmaceutical companies to the national academies — looked familiar to David Mitchell, president of Patients for Affordable Drugs and a cancer patient who relies for his survival on a drug with high waste costs.

"We have found in our work that pharma is like an octopus," he said, "and at the end of each tentacle is a wad of cash."

Waste Shocked Policymakers in 2016

Dr. Peter Bach and colleagues published an explosive paper in 2016 that for the first time showed that taxpayers and health insurance rate payers were bankrolling an estimated $2.8 billion a year in drug waste. The findings encompassed all U.S. healthcare — not just what's reported by doctor's offices to Medicare — and were covered widely in the news.

Bach, a researcher with the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, found that medications infused in doctors' offices often arrived in vial sizes fit for a linebacker but might be given to a waif. Given sterility and other concerns, the extra milligrams, often for cancer therapies that can cost thousands of dollars per dose, were typically discarded.

Congress and policymakers took notice.

In 2017, Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) introduced a bill urging healthcare agencies to develop a "joint action plan" to address the waste. Sens. Dick Durbin (D-Ill.) and Rob Portman (R-Ohio) introduced an even stronger measure in 2019 and again this year that would allow Medicare to recoup the cost of the wasted drugs. None of the bills has passed.

The refund mandate made it into a broader drug pricing measure that also failed, but not before the Congressional Budget Office took a close look in 2020 and estimated $9 billion could be saved over a decade.

Medicare officials also urged doctors to use a billing code to document the amount taxpayers were spending on wasted drugs each year — which amounted to $753 million in 2019 alone, Medicare data shows.

Before and while Bach's paper was making waves, physicians who would eventually be on the national academies committee were forging alliances with the pharmaceutical industry.

Dr. Kavita Patel reported earning a speaking fee in 2015 from the Pharmaceutical Research and Manufacturers of America, or PhRMA, of $5,001 to $15,000. She also accrued assets valued at more than $50,000 for her role as a pharmaceutical company board member, according to 2015 and 2018 disclosures filed with the Government Accountability Office.

Dr. Anupam Jena, who also served on the committee, wrote a 2018 article with staff members of PhRMA arguing that medications should be valued not for their actual benefit, but rather for the potential for innovation that comes with making new therapies.

The 'Kiss of Death'

In 2016, lawmakers called for an independent study of the drug waste. In September 2019, the National Academy of Sciences was awarded $1.2 million to complete the report.

At the outset of its study in January 2020, national academies committee members declared their potential conflicts of interest in a closed session, according to the meeting agenda.

Bach was among the physicians and other experts who later presented to the national academies committee. He said his team had laid out two possible solutions from the start: Have companies make a variety of vial sizes to minimize waste, or pursue refunds.

Former Medicare administrator Donald Berwickpresented to the committee at a June 2020, virtual meeting, exhorting its members to defy the expectation that they'd be one more committee that failed to do anything meaningful about health costs.

"Someone's got to begin to set a standard and say, 'Nope, this money is too important for … us to accede to this,'" Berwick told the committee.

The report's recommendations were "the result of extensive fact-finding, full committee discussions and unanimous consensus," said committee chairperson Dr. Edward Shortliffe, chair emeritus and adjunct professor in the Department of Biomedical Informatics at Columbia University.

The report, though, did not meet Berwick's call to action. In a webinar summarizing the report findings, Jena described the drugs as valuable enough to justify the total cost of each vial, completely used or not. Patel and others summarized the findings in a STAT opinion piece, saying the committee argued against tracking the money wasted and instead called for a "whole of government" approach.

Bach said the conclusions were "better than pharma could have ever hoped for" and called the whole-of-government idea the "kiss of death."

Berwick said that he was "disappointed" by the conclusions and that all committee members' industry relationships should have been reported. He noted that, in his experience, committee members have been very open about conflicts and the national academies dismissed those who had them.

Presented with KHN's findings about certain committee members' undisclosed pharmaceutical company income and consulting relationships, Bach said they raise serious concerns.

"The conflicts align just way too closely with the results," he said. "That's what makes it hard to ignore."

'Current' Conflicts Don't Tell Full Story

Conflicts of interest became a hot topic more than a decade ago, amid a series of scandals over Big Pharma quietly backing influential doctors.

Reforms followed, with countless medical journals, nonprofits and government agencies strengthening their conflict-of-interest policies.

The national academies came under scrutiny in 2014 and 2016 for failing to disclose conflicts among committee members advising federal officials on opioid use and in 2017 on genetically modified crops.

Its webpage on conflicts underscores why strong disclosure rules are important: "The institution should not be placed in a situation where others could reasonably question, and perhaps discount or dismiss, the work of the committee simply because of the existence of such conflicting interests."

Yet conflict-of-interest experts interviewed by KHN said the national academies stands out by considering only "current" conflicts and not those going back three years, as is more typical. Korsen said the National Academy of Sciences is working toward requiring five years of disclosures.

Several experts said that, given the trust placed in — and $200 million in federal funding awarded to — the national academies, a number of conflicts should have been disclosed in the report.

They include those of Patel, who is described in her report biography as a Brookings Institution fellow, a primary care physician in Washington, D.C., and former Obama administration policy adviser.

The national academies declined to provide the conflict-of-interest form that Patel or any other member filled out at the outset of the committee's work in early 2020.

Unrelated Securities and Exchange Commission records show that, before she joined the committee in 2020, Patel's role as a board member for Tesaro, a developer of cancer medications, became very lucrative when GlaxoSmithKline bought the company. At the time of the 2019 sale, Patel was in line to receive an estimated $1.4 million for her shares and stock options, according to a December 2018 Tesaro securities filing.

Also in 2020, Patel was appointed to the board of Sigilon Therapeutics, a biotech company with no product on the market. The company awarded her stock options then worth an estimated $369,000, an SEC filing shows.

Sigilon described state and federal efforts to control costs as a risk to its business in an annual report to investors: "Any cost containment measures could significantly decrease … the price we might establish for our products."

The national academies' lack of disclosure of those roles "to me is a violation of almost all the standards that I'm aware of for disclosing conflicts of interest," said Krimsky, of Tufts.

Patel told KHN she "fully and transparently participated" in the disclosure process and "provided all of the information requested." She said: "In addition, many of the financial relationships incurred over the course of my work had already been disclosed in the public record."

Patel was the lead writer on the Feb. 25 opinion piece in STAT that summarizes the committee's report as focusing on the need to reduce inefficiencies, "rather than on trying to recover from pharmaceutical companies the financial worth of the portion of drug that was not used."

Patel said she was "objective in all of my contributions" to the national academies report.

The national academies — as an organization — reported in its 2016 treasurer report that while 84% of its funding in 2011 was from federal agencies, the amount was failing. So it was working to "grow the non-federally sponsored work."

"It will be very important for the future of the institution to continue vigorous efforts to diversify its sources of income," the treasurer report says.

A KHN review of treasurer reports from 2015 through 2020 shows that pharmaceutical companies have given consistently to the national academies. Drugmakers donated at least $10 million over those years. Their giving is reported in ranges, often $100,000 to $500,000, and that total assumes they gave the lowest amount in each range each year.

A 2018 treasurer report recognized Merck & Co. for more than $5 million in cumulative giving and 10 other drugmakers for donating more than $1 million.

None of those donations was listed in the drug waste report. But listing them would reassure readers, said Genevieve Kanter, a University of Pennsylvania assistant professor of medical ethics and health policy.

"If the national academies is interested in producing a credible, independent report," she said, "I think they would report all of those donations in the report itself."

Jena, a Harvard Medical School associate professor, physician at Massachusetts General Hospital and an economist, also had no conflicts disclosed in the report.

Jena has disclosed consulting fees from a dozen major pharmaceutical companies, articles in the Journal of the American Medical Association and The BMJ show. Most of those companies have a direct financial interest in the drug waste matter, a KHN review of Medicare data shows. He said he disclosed all his consulting relationships to the national academies.

After the report came out, he took the lead on a Health Affairs article that says Medicare should stop tallying the waste money.

"Attempts by public payers to recoup overpayments are unlikely to be successful since they may simply end up paying higher prices" if drugmakers raise the price tag for the medications.

That article initially omitted his consulting relationships with numerous pharmaceutical companies — but journal editors updated the disclosures after KHN inquired.

Jay Hancock and Megan Kalata contributed to this report.

Christina Jewett: ChristinaJ@kff.org, @by_cjewett