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stephenmccull · 4 years ago

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National Academies’ Report Took Pharma-Friendly Stance After Millions in Gifts From Drugmakers

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. health care — 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 health care 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.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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mechanicswichita · 4 years ago

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malcolmarias93-blog · 4 years ago

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olko71 · 4 years ago

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Your Company Might Soon Offer a Covid Vaccine

Large employers, from the meatpacking industry to airlines and pharmaceutical companies, are getting permission from public-health officials to administer Covid-19 vaccines, hoping to speed up inoculations of their employees.

Many businesses see giving vaccine doses to employees at work as a way to efficiently vaccinate staff but, in doing so, are joining a race for scarce shots.

Pharmaceutical company AbbVie Inc. ABBV 0.99% has begun giving staff at its North Chicago headquarters doses, according to people familiar with the matter, giving priority to those over 65 years old and then workers in operations and manufacturing. Abbott Laboratories ABT 1.07% also has begun giving doses at its nearby headquarters to eligible workers, such as those in manufacturing, food service and daycare, a spokeswoman said, and Tyson Foods Inc. TSN 0.72% has delivered doses to staff at its Joslin, Ill., beef plant and to some workers in Iowa, a spokesman said.

Other large companies registered to provide doses include energy giant Exxon Mobil Corp. XOM 3.78% , meatpacker Smithfield Foods Inc. and machinery-makers Caterpillar Inc. and Deere DE 3.52% & Co., according to Illinois public-health records. Some of those companies run or are planning to run closed vaccine-giving events, meaning only their own staff are eligible, not the broader public. Sites are reliant on state and local public-health authorities for allocations of doses.

Money manager Fidelity Investments has registered to provide doses at its Boston headquarters and will begin giving shots to workers who are over 65 when it receives vaccines from Massachusetts, a spokesman said. A third-party health-and-wellness company will give the shots according to the state’s prioritization guidelines, he added.

Throughout the pandemic, companies have jostled for access to safety-related tools, such as protective gear and testing capacity to protect workers and give customers and staff more confidence in shared spaces. Now their focus has shifted to vaccines.

Dozens of people waited to get vaccinated in Houston Feb. 24.

Photo: Mark Mulligan/Houston Chronicle/Associated Press

Vaccine prioritization differs from state to state. In some jurisdictions, who is eligible for doses depends purely on age. In others, any worker in a prioritized sector, from healthcare to manufacturing, can get a dose regardless of whether their role involves interacting with the public, the ability to work from home or remotely, or the type of product they work on.

Companies that want to give shots to their workers typically have to register with public-health programs that approve who is eligible to receive allocations of Covid-19 vaccines. In general, the federal government allots doses to states, territories, a few large cities and some federal agencies, who then divvy them up among constituents or local health authorities.

Some healthcare-equity researchers say state prioritization guidelines can be overly broad, and risk having vaccine doses given to people who aren’t at a high risk of contracting Covid-19 at work when supply remains constrained nationwide.

Vaccination in the workplace helps remove transit and time-off challenges for hourly workers, and it does efficiently get doses to those in high-risk positions, such as those where social distancing isn’t possible, said Dr. Janice Bowie, professor in the department of health, behavior and society at the Johns Hopkins Bloomberg School of Public Health. It also highlights a problem with classifying entire sectors as essential, when workers’ roles, on-the-job risks and health conditions vary widely, she said.

President Biden said Tuesday that there will be enough vaccines available for all adults in the U.S. by the end of May, two months earlier than he had previously indicated, as Merck teams up to help Johnson & Johnson with vaccine production. Photo: Doug Mills/CNP via ZUMA

“This is certainly not black or white” from an ethical perspective, given the current limited supply of vaccines nationally, Dr. Bowie said about businesses receiving doses to give to staff.

Some healthcare-equity experts said Covid-19 vaccine administration by employers can help speed up distribution because it takes eligible workers out of line at public sites and eases the appointment-making process. The challenge is that not all companies seek or are granted dose allocations, they said.

“It’s a balancing act,” Mark Pfister, executive director of the Lake County Health Department in Illinois, said of allocations to dose administrators in his jurisdiction, which include Abbott and AbbVie. Vaccine supply has increased since the early days of the rollout, but many more entities now want doses, he said. His department asks companies to give priority to workers who are 65 and older, working close together on manufacturing lines or living in ZIP Codes hardest hit by Covid-19 hospitalizations and deaths.

Providing on-site doses gives employers better visibility into who has received shots than if workers traveled to publicly run facilities, corporate medical advisers say. It also saves employers missed hours if workers have to travel to vaccine-administration sites during business hours and saves staff the cost of lost wages, child care and transit.

“Employers have found this is the best way to get your population back to work as safely as possible,” said Tobias Barker, chief medical officer at Everside Health, which assists employers with vaccination events and record-keeping.

United Airlines and American Airlines are providing Covid-19 vaccines to certain employees at O’Hare International Airport in Chicago.

Photo: Scott Olson/Getty Images

An Abbott spokeswoman said the company is working with public-health officials in places where it has manufacturing facilities to offer vaccines to eligible workers when doses are available. Any vaccine doses the company receives go only to employees who meet government requirements for initial vaccine phases, she said.

A Deere & Co. spokeswoman said vaccines for its employees began last week at its five Illinois locations. It will make doses available to production and maintenance employees at its manufacturing units, and for salaried employees who consistently reported to its factories or offices since March 2020, which is a minority of such staff.

Keira Lombardo, chief administrative officer at Smithfield, said the company and its partners can facilitate rapid distribution of vaccines to food and agriculture workers and is doing so based on state-specific guidelines. The company is prepared to help with distribution to workers in other essential categories, she added.

An Exxon spokesman said doses would be given according to local health-authority requirements, prioritized for those in roles deemed critical by the company. A spokeswoman for Caterpillar declined to comment.

Airlines including United Airlines Holdings Inc. and American Airlines Group Inc. AAL -3.72% said they started giving doses of the Johnson & Johnson vaccine last week to certain staff at their respective health clinics at Chicago’s O’Hare International Airport. United said employees who live or work in Chicago would be eligible if they are at least 65 years old or are flight-crew members. American said its O’Hare-based mainline and regional employees are eligible, but those with customer-facing roles would be given priority.

SHARE YOUR THOUGHTS

Have you received any information from your employer on the vaccine? Share your stories with us. Join the conversation below.

The Biden administration expects to have vaccine doses available for all adults nationwide by May, though it isn’t clear when people would be able to receive them. Increases in vaccine supply have fanned some employers’ hopes for bringing staff back to offices this year.

Many have tried to encourage but not mandate vaccination. Several companies with public-facing staff, from Trader Joe’s to Instacart Inc. and Dollar General Corp. , have given workers the equivalent of several hours of pay in exchange for getting vaccinated.

Medical advisers say offering doses on site can create a network effect in which colleagues see their bosses or co-workers get doses and then become more receptive to doing so themselves.

—Alison Sider contributed to this article.

Covid-19 Vaccines

Write to Sarah Krouse at [email protected]

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daniels09stuff · 4 years ago

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towingserlas541 · 4 years ago

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norabliss · 4 years ago

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abqtowing505 · 4 years ago

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elijahjacobs1994 · 5 years ago

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christineharrington1994 · 5 years ago

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louisiana department of insurance license search

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Louisiana Insurance Continuing Education Course Category Restrictions

Louisiana Insurance Continuing Education Course Category Restrictions Listed below are additional information regarding the program and the course requirements. If any of the references in the post below is given, it’s not clear what the insurance continuing education provisions are for continuing education. After passing the insurance continuing education, the policy continues on the road that is still being driven. It may end up being used to complete the insurance continuing education course. After the policy is on the road, it is not required to continue the insurance continuing education required by the State of Nevada. No exceptions are found. There are no requirements as to what’s considered “failure by the end of the insurance continuing education period.” This is called the “failure period”. The insured is obligated to complete insurance continuing education if: He or she fails to complete the insurance continuing education required by the State of Nevada The insured makes a supplemental insurance continuing education course in which he or she completed the course. .

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Louisiana Insurance Continuing Education Exam Requirements

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Reporting and Louisiana Insurance Continuing Education Certificates of Completion

Reporting and Louisiana Insurance Continuing Education Certificates of Completion on an approved or non-approved basis and no matter if for work or for a certificate. The insurance Continuing Education course was graded and sent as an email. There were no specific deadlines that were stated in the certificate. There were no deadlines as to why the final exam had been delayed (the bill was not approved by the LTCI). There was no additional work or practice required. It is important that all prospective students be completely honest in their applications. These are very important courses to take each time for insurance continuing to pass the exam. For the full course, you can download . This can be helpful when applying for a new insurance continuing education certificate. We recommend completing all of the relevant required after hours courses to ensure that the course is valid from the outset. In addition, we recommend reviewing your education plan as soon as possible. Most of the course is ideal if you are just looking to get a credit for your continuing education. However, if there are any special needs, you.

Required Louisiana Insurance Continuing Education Hours

Required Louisiana Insurance Continuing Education Hours Please visit our website for a complete listing of your continuing education hours. We value your privacy. We may collect personal information from you such as credit information, demographic information and information we use to calculate your auto insurance quote. We may also utilize your information for marketing products and services and/or other purposes, including but not limited to, providing the products and services you request, processing your claims, protecting against fraud, maintaining security, confirming your identity and offering you other insurance and financial products. We look forward to hearing from you. We value your privacy. We may collect personal information from you such as identifying information (name*, address*, driver/owner s license number), transactional information (products or services purchased and payment history), digital network activity (interactions with our website, IP address), geo-location data and embedded devices. We use this information for business, marketing and commercial purposes, including but not limited to, providing the products and services you request, processing your claims, protecting.

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olgagarmash · 4 years ago

Link

The U.S. is one step closer to making available another Covid-19 vaccine after a panel of experts voted unanimously Friday to recommend emergency use authorization for a shot developed by Johnson & Johnson.

The independent panel, comprised of mostly physicians, voted 22-0 to support the vaccine with no one abstaining. These votes aren’t binding on the FDA, but the agency often follows the recommendations of its panels. A decision could come as early as this weekend. The two Covid vaccines currently cleared for emergency use received their authorizations the day after their respective advisory panel meetings.

The Johnson & Johnson vaccine would offer an alternative to the ones currently available from the Pfizer and BioNtech alliance, and Moderna. Those messenger RNA vaccines must be distributed and stored at ultra-cold temperatures, then thawed before use. Those shots are given as two doses, weeks apart. The J&J vaccine can be kept at refrigerator temperatures. Another key difference is that the J&J jab requires a single shot. Together, those features will make the J&J vaccine easier to distribute to more people in more places through distribution channels that are already in place.

Panel members expressed support for the J&J vaccine, saying that the safety and efficacy data supported its authorization. But panelists also cautioned the public against picking vaccine favorites.

“It’s important that people do not think one vaccine is better than another,” said Cody Meissner, an infectious disease expert and professor of pediatrics at the Tufts University School of Medicine. “There is no preference for one vaccine over another and all vaccines work with what appears to be equal safety and equal efficacy as of this time.”

Emergency authorization is not the same as an approval. Federal law permits the FDA to allow marketing of unapproved medical products for emergency situations, such as a pandemic. Authorizations only last for the duration of the emergency. These authorizations can also be revoked if new data show that the product is not safe or effective. Stanley Perlman, a professor in the departments of microbiology and immunology at the University of Iowa, said that while the clinical studies to date have produced data about the vaccine’s safety and efficacy, it would be “nice to have more.”

The J&J vaccine may be new, but compared to the mRNA vaccines, the technology behind it has bit of a longer track record. J&J vaccine makes it using its AdVac technology, the same platform that produced the company’s Ebola vaccine, which the FDA approved in 2019. The technology takes the virus that causes the common cold and modifies it so it doesn’t cause illness. That engineered virus is the delivery vehicle that ferries into cells a snippet of genetic code for the novel coronavirus’s spike protein. The genetic material serves as the blueprint from which the body’s cells produce spike proteins. The immune system responds by producing antibodies to those proteins, conferring immunity.

The clinical data to date for J&J Covid vaccine covers 44,000 adults from all over the world. In Phase 3 data reported in late January, the vaccine was 66% effective overall in preventing moderate-to-severe infection, 28 days after vaccination. Furthermore, the vaccine showed 85% efficacy in preventing severe disease, and showed complete protection against Covid-related hospitalization and death, also measured at day 28.

Those marks look inferior to the greater than 90% efficacy demonstrated in mRNA vaccine trials. But cross-trial comparisons are difficult and can be misleading because trials have different designs and different goals. Also, the mRNA studies were conducted earlier in the year when there were fewer variants circulating. Public health experts have said that if those vaccines were tested under current conditions, their efficacy rates might be lower, too.

Plans are already underway to gather more data about J&J’s shot, including a study of the vaccine in children and teens. Johan Van Hoof, the global head of the infectious diseases and vaccines for J&J’s Janssen subsidiary, told the advisory panel that a clinical trial testing the vaccine in those 17 and younger is expected to begin this spring. He also said that the company is assessing how the vaccine responds to variants of the novel coronavirus.

Shortly after Friday’s meeting, the FDA issued a statement saying that it would “rapidly work” with J&J toward finalization and issuance of an emergency use authorization. The agency added that it has notified federal partners involved in the allocation and distribution of vaccines, so that they are ready.

Photo: Getty Images, Sezeryadigar

via Wealth Health

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brewerlinda1995 · 5 years ago

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