Three Predictable Covid Nightmares — and How Congress Can Help Prevent Them

https://www.politico.com/news/agenda/2020/07/29/states-congress-covid-nightmare-vaccine-385217?mkt_tok=eyJpIjoiTVRNNU0yWXpNMlk1TVRsaiIsInQiOiJ1Vlg3dlBCYytaWTdtcGtMd3ZaUVh6TTBZRlMxXC9MaW9UMk9MRHhpdkFpSFFJMHFVWWpocUhWR1ZEZTM2NFBXb0xOVUZTSXNJMzYxWk90Yld

Opinion | Three Predictable Covid Nightmares — and How Congress ...

The good news is that they aren’t partisan, and they’re fixable.

In our response to the Covid-19 pandemic, the United States has all too often been caught flat-footed. Our public officials have tried to avoid or deny problems until they have been right on top of us, and legislative measures have tended to react to major challenges rather than avert them.

That has left policymakers with a lot to react to. And the relief and assistance bill now being worked out in the Senate will need to do that on several fronts. But to do better in the future, that bill should also take on several predictable problems that will face our country over the remainder of the year and which could benefit enormously from some advance attention and action.

Three sets of such predictable problems stand out above all, and in all three cases there are measures that can be taken now that should be able to attract bipartisan support.

First, states are going to face a monumental fiscal crisis.

The pandemic and the ensuing shutdowns of economic activity have left state governments with immense revenue shortages. Balanced-budget amendments in all but one state severely restrict their capacity to run deficits, in many cases even in major emergencies. That means states will have to either find other ways to raise revenue quickly or make major cuts to basic services. Such cuts in spending, jobs and public assistance would exacerbate the deep recession we are in and leave millions who need help in the lurch.

Most state fiscal years begin in July, so in many cases budgets designed or enacted before the severity of the crisis was clear are now starting to take effect, leaving states facing gaps they can easily predict but haven’t formally accounted for. In fact, 16 states are now starting the second year of biennial budgets enacted in 2019, before anyone could have imagined the sort of crisis we now face. Over the coming months, there will be no avoiding the fiscal crunch.

The states have already begun pleading with Congress for help, and sooner or later Congress will need to provide it. Taking steps sooner rather than later would make an enormous difference. The federal government has often been called on to serve as a fiscal backstop for states in extreme emergencies, since its borrowing power vastly exceeds that of the states. And that role is particularly appropriate in a truly national—indeed global—crisis of this magnitude.

But to provide such help responsibly, Congress will need to clearly delineate what kinds of assistance it can offer and on what terms. Congressional Republicans are not wrong to be wary of state efforts to use the emergency to fill fiscal holes dug over decades of irresponsible state policies. Yet that can’t mean that they deny state governments the help they need to contend with this crisis. Rather, it means they must draw some distinctions.

As I’ve argued elsewhere, Congress would do well to divide state needs into three tranches: direct pandemic spending (which should be covered by federal dollars), lost state revenue (which states should be given the opportunity to make up with federally guaranteed loans on favorable terms), and longstanding obligations like pension and retiree health costs made untenable by the recession (for which affected states should be given options only for strictly conditional support, like a new state bankruptcy code or federal support conditioned on major pension reforms).

To be effective, that sort of response would need to take shape now, before states have truly hit the wall. It should be part of the bill the parties are now beginning to negotiate.

Second, this fall’s election is going to be seriously complicated by the pandemic.

There is pretty much no way around that. We’ll be voting while the virus is still spreading, which means that far more people than usual will vote by mail. Only a few states have real experience with voting by mail in large numbers, and the logistics involved are not simple. Primary elections in many states have already made the challenge clear.

To take just one example among many, mailed ballots require signature verification. In states that haven’t spent years building the required infrastructure, such verification will probably need to be done by hand, creating huge risks of confusion and error. States will need to develop new processes to handle this, to train election workers to use unfamiliar equipment, and to take on problems in real time. Signature verification also requires a process for notifying voters whose handwriting is challenged and giving them time to respond. All that, and similar challenges on other election administration fronts, makes it easy to imagine that many races will be impossible to call on election night, and perhaps for quite some time afterward.

Particularly in an era already overflowing with cynical mistrust and conspiracy mongering, such problems raise the prospect of a legitimacy crisis around the election. And policymakers need to take steps now to reduce the risk of such a crisis.

The first step must be to prepare the public. Elected officials, candidates, journalists and others must start speaking plainly about the likelihood of logistical challenges around the election so that voters are not shocked if things don’t go smoothly. People must know in advance that we should not expect every race to be called straight away and that results which take days or even weeks to determine are not therefore illegitimate.

But beyond setting voter expectations, policymakers should also be looking for ways to reduce the strain on the system and to deal with predictable problems. One simple step Congress could take now is to push back the deadlines involved in the work of the Electoral College, to give the states more time to count votes in the presidential race if they need it. A simple change in the federal law governing these dates, which wouldn’t give either party an advantage, could give every state about three more weeks to count. Such a change would be essentially impossible after the election—when partisans looking at partial results would argue over which side it would advantage. But it could easily be done today, it would just take a few sentences of legislative language, and it too should be part of the relief bill now being worked out.

Opinion | Three Predictable Covid Nightmares — and How Congress ...

Finally, if we’re lucky, we’re going to need to figure out how to distribute a Covid-19 vaccine early next yearThat would be a good problem to have, of course, but a huge problem nonetheless. And getting it wrong could catastrophically undermine the effort to defeat the virus.

Vaccine development itself is one area where our country has not been behind the curve: The federal government has invested heavily in the effort, the National Institutes of Health has played a key coordinating role, and the administration is prepared to pay for “at risk” manufacturing of millions of doses of any vaccine that makes it into Phase III trials, so that if a vaccine is found to be safe and effective there will immediately be doses to provide to high-risk individuals. But who will be first in line to get these early doses? And who will decide?

Here, too, there is an enormous danger of a legitimacy crisis. Both public fear about the safety of a vaccine (building on decades of anti-vaccine conspiracy theories on the right and left alike) and the danger of corruption, or at least perceived corruption, in the distribution of doses could undermine the potential of effective vaccination to end the nightmare of this pandemic.

Widespread uptake is essential to the effectiveness of any vaccine. It is not so much by protecting each vaccinated individual as by vaccinating enough Americans to achieve broad-based communal (or “herd”) immunity that a vaccine could truly change the game. That means public trust in the process and wholesale vaccination across our society will be crucial.

To achieve that, it is essential that both the safety of the vaccine-development process and the basic fairness of the ultimate distribution formula be established in advance, and in a very public way. Congress has a crucial role to play here, too. Hearings should begin very soon to put before the public all available information about the efforts taken by the Food and Drug Administration to ensure the safety of the vaccine-development process, even as that process proceeds with unprecedented speed. And Congress should establish, ideally in this next relief bill, a public commission to develop a formula for equitable distribution of early vaccine doses: setting out tiers of priority (for front-line health workers, vulnerable populations, the elderly, and those with particular preexisting conditions), and seeking out ways to make sure that economic and other disadvantages do not translate into lesser or later access to vaccination.

The work of such a group should be reasonably transparent and would need to begin very soon if it is to bear fruit in time to be useful. Policymakers must not underestimate the danger of a loss of public confidence in a Covid-19 vaccine, and must take steps now to avoid such a foreseeable disaster.

The same is true on all three of these fronts. These may not be the greatest problems we confront in the remainder of this dark and difficult year, but they share some features that ought to make them high priorities: All three are predictable and serious, each would amount to a disaster if left unchecked, but each could be made much easier to handle with some straightforward preparation. The relief bill being negotiated this summer could easily, without sparking a partisan war, take concrete steps on all three fronts.

Leadership in a crisis demands a combination of planning for foreseeable difficulties and responding to the unexpected. Getting the former right can make the latter far more doable. To make the rest of this year less disastrous, our leaders need to look ahead.

 

Coronavirus drugmakers’ latest tactics: Science by press release

https://www.politico.com/news/2020/06/05/drugmakers-media-coronavirus-303895

Coronavirus drugmakers' latest tactics: Science by press release ...

Pharmaceutical companies are using the media to tout treatments that are still under review.

Vaccine maker Moderna attracted glowing headlines and bullish investors when it revealed that eight participants in a preliminary clinical trial of its coronavirus vaccine had developed antibodies to the virus. The company’s share price jumped nearly 20 percent that day as it released a massive stock offering.

But the full results of the 45-person safety study haven’t been published, even though Moderna began a second, larger trial in late May aimed at determining whether the vaccine works. Several vaccine researchers say the scant public information on the earlier safety study is hard to evaluate because it addresses less than 20 percent of participants.

Call it science by press release — a tactic that pharmaceutical companies are increasingly relying upon to set their experimental coronavirus drugs and vaccines apart in a crowded field, shape public opinion and court regulators. Public health experts say the approach could increase political pressure on federal health officials to green-light drugs and vaccines before it is clear they are safe or effective, with potentially dangerous consequences.

“There’s a long history of pharmaceutical manufacturers putting out self-serving press releases related to clinical trial data that they’re developing that present an overly rosy picture of the data, usually with a boilerplate disclaimer at the end, which is fairly useless,” said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug regulation and pricing.

There are already signs of hype and political pressure influencing the U.S.’ coronavirus response. The Food and Drug Administration authorized emergency use of the malaria drug hydroxychloroquine in March without any proof that it was safe or effective for coronavirus patients — but with the backing of President Donald Trump, who had begun touting the treatment during daily White House briefings.

Subsequent studies have found that hydroxychloroquine doesn’t help those with Covid-19 and can cause potentially fatal side effects. And a top government scientist, Rick Bright, filed a whistleblower complaint in May alleging that he was ousted from his job leading the Biomedical Advanced Research Authority after he resisted political pressure to greenlight widespread use of the drug.

“The FDA has remained an unwavering, science-based voice helping to guide the all-of-government response,” agency Commissioner Stephen Hahn said in a statement. “I have never felt any pressure to make decisions, other than the urgency of the situation around COVID-19.”

But observers aren’t so sure. “From the outside looking in, there seems to be more political pressure than ever,” said Marc Scheineson, a former associate commissioner at the FDA and head of the FDA group at Alston & Bird. “The example in the White House is trickling down and there is a lot of pressure on the FDA … to color information on the optimistic side for political purposes and that is a hugely disturbing trend.”

A spokesperson for Moderna, which has received nearly a half billion dollars from the U.S. government and praise from Trump, said the company previewed its vaccine trial results by press release because it was concerned that the data might leak. The National Institutes of Health’s top infectious disease expert, Anthony Fauci, had hinted at the results in an interview with National Geographic, and data from a trial of the experimental drug remdesivir had leaked in April.

“You had this data moving widely around NIH and the remdesivir leak was also in our minds,” the Moderna spokesperson said.

But Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes, said Moderna’s effort to preview its findings in the press “could be construed as an effort to make sure they are part of the conversation — and it worked on that front.”

Other groups have also previewed their hotly anticipated vaccine studies in the press. In late April, The New York Times revealed that six monkeys given a vaccine developed by researchers at the U.K.’s University of Oxford had stayed healthy for 28 days despite sustained exposure to the coronavirus. The article quoted Vincent Munster, a researcher at the NIH’s Rocky Mountain Laboratory, which conducted the monkey study at the British scientists’ behest.

The Oxford researchers, who signed a deal with AstraZeneca two days later to develop the experimental vaccine, did not publish a formal scientific analysis of the monkey data until mid-May. The study revealed that the noses of vaccinated monkeys and unvaccinated monkeys contained similar levels of coronavirus particles, suggesting that the vaccinated animals could still spread the disease — and the vaccine might not be as effective as the earlier data had hinted.

AstraZeneca has since inked a $1.2 billion deal with the U.S. government to provide 300 million vaccine doses, and a £65.5 million ($80 million) agreement with the U.K. government to supply 30 million doses.

Liz Derow, a spokesperson for Oxford’s Jenner Institute, where the vaccine researchers are based, said they did not give the monkey data to The New York Times. The NIH’s National Institute of Allergy and Infectious Disease, which operates the Rocky Mountain Laboratory, said it did not provide the data to the newspaper — but one of its researchers, Vincent Munster, spoke to a Times reporter about the monkey findings at the request of the Jenner Institute.

“I was really disturbed by not just Moderna, but the Oxford group as well, presenting a press release without data, without a scientific review, without knowing what the press release was based on,” said Barry Bloom, an immunologist at the Harvard School of Public Health. “And very positively enough to raise the stock price so two days later officials within the company sold their stock and made a whole lot of money, whether or not the vaccine works.”

Four of the pharmaceutical firm’s top executives together saw gains of $29 million from prescheduled sales of shares in the company in the two days following the vaccine announcement. The company has not yet responded to a request for comment on the stock sales.

Neither the Oxford nor Moderna vaccines are available to the public. But some drugs whose safety and efficacy are now being studied have already been repurposed or authorized for emergency use during the pandemic. The rush to release snippets of information on drug trials to the press ahead of full results has left some doctors wondering how to best treat their patients.

After leaked data from a trial of Gilead’s experimental antiviral remdesivir suggested the drug might be the first shown to help coronavirus patients, the company put out a press release in late April teasing results from a larger, government-run study. Hours later, Fauci revealed some findings of the study during an Oval Office press spray.

But the full analysis of the NIAID trial results was not published until three weeks later. Until that point, frontline physicians had no way to know that patients on ventilators did not benefit from remdesivir treatment — meaning that doctors may have inadvertently wasted some of the United States’ limited stock of the drug.

This lack of understanding on how to use remdesivir was evident in a recent survey more than 250 hospitals by the American Society of Health-System Pharmacists, which found that just 15 percent planned to use their remdesivir doses as described in the FDA’s emergency authorization for the drug.

Andre Kalil, an infectious disease doctor at the University of Nebraska Medical Center who led the NIAID trial, told POLITICO that physicians could have patterned their use of remdesivir on the dosages given during the trial.

Others say doctors using experimental treatments should have as much information as possible.

“If we want doctors to make rational medical decisions based on data, then before an authorized product reaches patients, the data should be available to review in some way, not just a press release,” said Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing.

Kesselheim, too, said that clinical trial data should be made public alongside any emergency authorizations to give physicians “the maximum amount of help they need in figuring out how to prescribe the drug.”

Gilead did not respond to a request for comment. But NIAID said that the urgency of the coronavirus prompted Fauci to share initial results before a full analysis was ready for publication.

Ivan Oransky, a professor of medical journalism at New York University and co-founder of the blog Retraction Watch, which monitors errors and misconduct in scientific research, told POLITICO he fears that the temptation to conduct science by press release will get “worse before it gets better.”

The world is growing more desperate for drugs and vaccines that could bring the coronavirus to heel. And many members of the public and politicians are treating every scrap of scientific information about the pandemic equally, he said — whether data comes from a peer-reviewed study or a company press release.

“There have been mechanisms to review science critically that, given the speed of Covid, have gone out the window,” said Bloom.

And interpreting results of clinical trial data can be difficult under the best of circumstances — especially when that data concerns a virus that was unknown to science until December of last year. When to end a trial and which conclusions to highlight are in many cases a matter of discretion, said Scheineson.

“It’s an art, not a science, in that respect,” he said. “I, for one, will not be the first in line to the new Moderna vaccine.”

 

 

 

 

Major study finds common steroid reduces deaths among patients with severe Covid-19

Major study finds common steroid reduces deaths among patients with severe Covid-19

What is Dexamethasone? | What Is News,The Indian Express

A cheap, readily available steroid drug reduced deaths by a third in patients hospitalized with Covid-19 in a large study, the first time a therapy has been shown to possibly improve the odds of survival with the condition in the sickest patients.

Full data from the study have not been published or subjected to scientific scrutiny. But outside experts on Tuesday immediately embraced the top-line results. The drug, dexamethasone, is widely available and is used to treat conditions including rheumatoid arthritis, asthma, and some cancers.

In a statement, Patrick Vallance, the U.K. government’s chief scientific adviser, called the result “tremendous news” and “a ground-breaking development in our fight against the disease.” Scott Gottlieb, a former commissioner of the U.S. Food and Drug Administration, called it “a very positive finding” in an interview on CNBC. “I think it needs to be validated, but it certainly suggests that this could be beneficial in this setting.”

Atul Gawande, the surgeon, writer and public health researcher, urged caution, tweeting, “after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper.”

The study randomly assigned 2,104 patients to receive six milligrams of dexamethasone once a day, by mouth or intravenous injection. These were compared to 4,321 patients assigned to receive usual care alone.

In patients who needed to be on a ventilator, dexamethasone reduced the death rate by 35%, meaning that doctors would prevent one death by treating eight ventilated patients. In those who needed oxygen but were not ventilated, the death rate was reduced 20%, meaning doctors would need to treat 25 patients to save one life. Both results were statistically significant.

There was no benefit in patients who didn’t require any oxygen. The researchers running the study, called RECOVERY, decided to stop enrolling patients on dexamethasone on June 8 because they believed they had enough data to get a clear result.

“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” Peter Horby, one of the lead investigators of the study and a professor in the Nuffield Department of Medicine at the University of Oxford, said in a statement. He added that the drug should now become the standard treatment for patients with Covid-19 who need oxygen. “Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.’”

A different arm of the same study showed on June 5 that hydroxychloroquine, widely touted as a potential Covid treatment, had no benefit in hospitalized patients. Yesterday, based in part on those results, the Food and Drug Administration revoked an Emergency Use Authorization for using hydroxychloroquine in those patients.

From the start of the pandemic in March, researchers have focused on two different stages of Covid-19, which will likely require very different interventions. Some drugs are designed to directly combat the novel coronavirus, SARS-CoV-2, that causes the disease. The first medicine shown to have a benefit, remdesivir from the biotech firm Gilead Sciences, falls into this category, even though, because it must be given intravenously, it has been tested in hospitalized patients. Remdesivir shortens the course of infection, but has not been shown to save lives.

After patients have become profoundly sick, the problem starts to become not only the virus but their own immune system, which attacks the lungs, a condition called acute respiratory distress syndrome, or ARDS. For these patients, doctors have believed, they would need to dampen patients’ immune response even as they fought the virus.

Initially, excitement in this area fell on new and expensive drugs, such as Actemra, a rheumatoid arthritis drug from Roche that is used to treat a similar condition caused by some cancer immunotherapies. But a study in patients who needed oxygen showed no benefit from a similar drug, although another arm in sicker patients is continuing. The National Institutes of Health is conducting a study of an Eli Lilly pill targeting rheumatoid arthritis, an extension of the study that showed remdesivir has a benefit.

Dexamethasone, which reached the market 59 years ago, seemed an unlikely candidate to help these patients; it was seen as too crude a way of tamping down the immune system. In guidelines for physicians treating the disease, the NIH doesn’t even mention the therapy.

Studies that are testing other medicines may now need to incorporate the use of the drug, which could complicate analyzing the results. A spokesperson for Regeneron, which is testing Covid-19 drugs focused on both attacking the virus and dampening the immune system, said the company’s studies are written so that when a new medicine becomes the standard of care, it becomes available to patients in the trial.

Some studies have shown a benefit for using dexamethasone in acute respiratory distress syndrome not related to Covid-19, although the benefit was smaller than in RECOVERY. 

The result, should it hold up to further scrutiny, shows the benefit of the strategy of Horby and Martin Landray, the Oxford researchers who designed the study, leveraging the U.K. health system to start a study of multiple inexpensive potential Covid-19 therapies — including hydroxychloroquine, dexamethasone, and also some older HIV medicines. Several months into the Covid-19 pandemic, two of the most important results come from this single study.

Neither of those results, however, have been scrutinized or published.

 

 

 

BANKS PRESSURE HEALTH CARE FIRMS TO RAISE PRICES ON CRITICAL DRUGS, MEDICAL SUPPLIES FOR CORONAVIRUS

https://theintercept.com/2020/03/19/coronavirus-vaccine-medical-supplies-price-gouging/

Image result for BANKS PRESSURE HEALTH CARE FIRMS TO RAISE PRICES ON CRITICAL DRUGS, MEDICAL SUPPLIES FOR CORONAVIRUS

IN RECENT WEEKS, investment bankers have pressed health care companies on the front lines of fighting the novel coronavirus, including drug firms developing experimental treatments and medical supply firms, to consider ways that they can profit from the crisis.

The media has mostly focused on individuals who have taken advantage of the market for now-scarce medical and hygiene supplies to hoard masks and hand sanitizer and resell them at higher prices. But the largest voices in the health care industry stand to gain from billions of dollars in emergency spending on the pandemic, as do the bankers and investors who invest in health care companies.

Over the past few weeks, investment bankers have been candid on investor calls and during health care conferences about the opportunity to raise drug prices. In some cases, bankers received sharp rebukes from health care executives; in others, executives joked about using the attention on Covid-19 to dodge public pressure on the opioid crisis.

Gilead Sciences, the company producing remdesivir, the most promising drug to treat Covid-19 symptoms, is one such firm facing investor pressure.

Remdesivir is an antiviral that began development as a treatment for dengue, West Nile virus, and Zika, as well as MERS and SARS. The World Health Organization has said there is “only one drug right now that we think may have real efficacy in treating coronavirus symptoms” — namely, remdesivir.

The drug, though developed in partnership with the University of Alabama through a grant from the federal government’s National Institutes of Health, is patented by Gilead Sciences, a major pharmaceutical company based in California. The firm has faced sharp criticism in the past for its pricing practices. It previously charged $84,000 for a yearlong supply of its hepatitis C treatment, which was also developed with government research support. Remdesivir is estimated to produce a one-time revenue of $2.5 billion.

During an investor conference earlier this month, Phil Nadeau, managing director at investment bank Cowen & Co., quizzed Gilead Science executives over whether the firm had planned for a “commercial strategy for remdesivir” or could “create a business out of remdesivir.”

Johanna Mercier, executive vice president of Gilead, noted that the company is currently donating products and “manufacturing at risk and increasing our capacity” to do its best to find a solution to the pandemic. The company at the moment is focused, she said, primarily on “patient access” and “government access” for remdesivir.

“Commercial opportunity,” Mercier added, “might come if this becomes a seasonal disease or stockpiling comes into play, but that’s much later down the line.”

Steven Valiquette, a managing director at Barclays Investment Bank, last week peppered executives from Cardinal Health, a health care distributor of N95 masks, ventilators and pharmaceuticals, on whether the company would raise prices on a range of supplies.

Valiquette asked repeatedly about potential price increases on a variety of products. Could the company, he asked, “offset some of the risk of volume shortages” on the “pricing side”?

Michael Kaufmann, the chief executive of Cardinal Health, said that “so far, we’ve not seen any material price increases that I would say are related to the coronavirus yet.” Cardinal Health, Kaufman said, would weigh a variety of factors when making these decisions, and added that the company is “always going to fight aggressively to make sure that we’re getting after the lowest cost.”

“Are you able to raise the price on some of this to offset what could be some volume shortages such that it all kind of nets out to be fairly consistent as far as your overall profit matrix?” asked Valiquette.

Kaufman responded that price decisions would depend on contracts with providers, though the firm has greater flexibility over some drug sales. “As you have changes on the cost side, you’re able to make some adjustments,” he noted.

The discussion, over conference call, occurred during the Barclays Global Healthcare Conference on March 10. At one point, Valiquette joked that “one positive” about the coronavirus would be a “silver lining” that Cardinal Health may receive “less questions” about opioid-related lawsuits.

Cardinal Health is one of several firms accused of ignoring warnings and flooding pharmacies known as so-called pill mills with shipments of millions of highly addictive painkillers. Kaufmann noted that negotiations for a settlement are ongoing.

Owens & Minor, a health care logistics company that sources and manufactures surgical gowns, N95 masks, and other medical equipment, presented at the Barclays Global Healthcare Conference the following day.

Valiquette, citing the Covid-19 crisis, asked the company whether it could “increase prices on some of the products where there’s greater demand.” Valiquette then chuckled, adding that doing so “is probably not politically all that great in the sort of dynamic,” but said he was “curious to get some thoughts” on whether the firm would consider hiking prices.

The inquiry was sharply rebuked by Owens & Minor chief executive Edward Pesicka. “I think in a crisis like this, our mission is really around serving the customer. And from an integrity standpoint, we have pricing agreements,” Pesicka said. “So we are not going to go out and leverage this and try to ‘jam up’ customers and raise prices to have short-term benefit.”

AmerisourceBergen, another health care distributor that supplies similar products to Cardinal Health, which is also a defendant in the multistate opioid litigation, faced similar questions from Valiquette at the Barclays event.

Steve Collis, president and chief executive of AmerisourceBergen, noted that his company has been actively involved in efforts to push back against political demands to limit the price of pharmaceutical products.

Collis said that he was recently at a dinner with other pharmaceutical firms involved with developing “vaccines for the coronavirus” and was reminded that the U.S. firms, operating under limited drug price intervention, were among the industry leaders — a claim that has been disputed by experts who note that lack of regulation in the drug industry has led to few investments in viral treatments, which are seen as less lucrative. Leading firms developing a vaccine for Covid-19 are based in Germany, China, and Japan, countries with high levels of government influence in the pharmaceutical industry.

AmerisourceBergen, Collis continued, has been “very active with key stakeholders in D.C., and our priority is to educate policymakers about the impact of policy changes,” with a focus on “rational and responsible discussion about drug pricing.”

Later in the conversation, Valiquette asked AmerisourceBergen about the opioid litigation. The lawsuits could cost as much as $150 billion among the various pharmaceutical and drug distributor defendants. Purdue Pharma, one of the firms targeted with the opioid litigation, has already pursued bankruptcy protection in response to the lawsuit threat.

“We can’t say too much,” Collis responded. But the executive hinted that his company is using its crucial role in responding to the pandemic crisis as leverage in the settlement negotiations. “I would say that this crisis, the coronavirus crisis, actually highlights a lot of what we’ve been saying, how important it is for us to be very strong financial companies and to have strong cash flow ability to invest in our business and to continue to grow our business and our relationship with our customers,” Collis said.

The hope that the coronavirus will benefit firms involved in the opioid crisis has already materialized in some ways. New York Attorney General Letitia James announced last week that her lawsuit against opioid firms and distributors, including Cardinal Health and AmerisourceBergen, set to begin on March 20, would be delayed over coronavirus concerns.

MARKET PRESSURE has encouraged large health care firms to spend billions of dollars on stock buybacks and lobbying, rather than research and development. Barclays declined to comment, and Cowen & Co. did not respond to a request for comment.

The fallout over the coronavirus could pose potential risks for for-profit health care operators. In Spain, the government seized control of private health care providers, including privately run hospitals, to manage the demand for treatment for patients with Covid-19.

But pharmaceutical interests in the U.S. have a large degree of political power. Health and Human Services Secretary Alex Azar previously served as president of the U.S. division of drug giant Eli Lilly and on the board of the Biotechnology Innovation Organization, a drug lobby group.

During a congressional hearing last month, Azar rejected the notion that any vaccine or treatment for Covid-19 should be set at an affordable price. “We would want to ensure that we work to make it affordable, but we can’t control that price because we need the private sector to invest,” said Azar. “The priority is to get vaccines and therapeutics. Price controls won’t get us there.”

The initial $8.3 billion coronavirus spending bill passed in early March to provide financial support for research into vaccines and other drug treatments contained a provision that prevents the government from delaying the introduction of any new pharmaceutical to address the crisis over affordability concerns. The legislative text was shaped, according to reports, by industry lobbyists.

As The Intercept previously reported, Joe Grogan, a key White House domestic policy adviser now serving on Donald Trump’s Coronavirus Task Force, previously served as a lobbyist for Gilead Sciences.

“Notwithstanding the pressure they may feel from the markets, corporate CEOs have large amounts of discretion and in this case, they should be very mindful of price gouging, they’re going to be facing a lot more than reputational hits,” said Robert Weissman, president of public interest watchdog Public Citizen, in an interview with The Intercept.

“There will be a backlash that will both prevent their profiteering, but also may push to more structural limitations on their monopolies and authority moving forward,” Weissman said.

Weissman’s group supports an effort led by Rep. Andy Levin, D-Mich., who has called on the government to invoke the Defense Production Act to scale up domestic manufacturing of health care supplies.

There are other steps the government can take, Weissman added, to prevent price gouging.

“The Gilead product is patent-protected and monopoly-protected, but the government has a big claim over that product because of the investment it’s made,” said Weissman.

“The government has special authority to have generic competition for products it helped fund and prevent nonexclusive licensing for products it helped fund,” Weissman continued. “Even for products that have no connection to government funding, the government has the ability to force licensing for generic competition for its own acquisition and purchases.”

Drug companies often eschew vaccine development because of the limited profit potential for a one-time treatment. Testing kit companies and other medical supply firms have few market incentives for domestic production, especially scaling up an entire factory for short-term use. Instead, Levin and Weissman have argued, the government should take direct control of producing the necessary medical supplies and generic drug production.

Last Friday, Levin circulated a letter signed by other House Democrats that called for the government to take charge in producing ventilators, N95 respirators, and other critical supplies facing shortages.

The once inconceivable policy was endorsed on Wednesday when Trump unveiled a plan to invoke the Defense Production Act to compel private firms to produce needed supplies during the crisis. The law, notably, allows the president to set a price ceiling for critical goods used in an emergency.

 

 

 

 

BIG PHARMA PREPARES TO PROFIT FROM THE CORONAVIRUS

https://theintercept.com/2020/03/13/big-pharma-drug-pricing-coronavirus-profits/?fbclid=IwAR3GaO3iDDuiIKbx2UUaYzU3_3fIfYlwvd6II3neLfK67IcmZpJ_acEv_2k

Image result for BIG PHARMA PREPARES TO PROFIT FROM THE CORONAVIRUS

AS THE NEW CORONAVIRUS spreads illness, death, and catastrophe around the world, virtually no economic sector has been spared from harm. Yet amid the mayhem from the global pandemic, one industry is not only surviving, it is profiting handsomely.

“Pharmaceutical companies view Covid-19 as a once-in-a-lifetime business opportunity,” said Gerald Posner, author of “Pharma: Greed, Lies, and the Poisoning of America.” The world needs pharmaceutical products, of course. For the new coronavirus outbreak, in particular, we need treatments and vaccines and, in the U.S., tests. Dozens of companies are now vying to make them.

“They’re all in that race,” said Posner, who described the potential payoffs for winning the race as huge. The global crisis “will potentially be a blockbuster for the industry in terms of sales and profits,” he said, adding that “the worse the pandemic gets, the higher their eventual profit.”

The ability to make money off of pharmaceuticals is already uniquely large in the U.S., which lacks the basic price controls other countries have, giving drug companies more freedom over setting prices for their products than anywhere else in the world. During the current crisis, pharmaceutical makers may have even more leeway than usual because of language industry lobbyists inserted into an $8.3 billion coronavirus spending package, passed last week, to maximize their profits from the pandemic.

Initially, some lawmakers had tried to ensure that the federal government would limit how much pharmaceutical companies could reap from vaccines and treatments for the new coronavirus that they developed with the use of public funding. In February, Rep. Jan Schakowsky, D-Ill., and other House members wrote to Trump pleading that he “ensure that any vaccine or treatment developed with U.S. taxpayer dollars be accessible, available and affordable,” a goal they said couldn’t be met “if pharmaceutical corporations are given authority to set prices and determine distribution, putting profit-making interests ahead of health priorities.”

When the coronavirus funding was being negotiated, Schakowsky tried again, writing to Health and Human Services Secretary Alex Azar on March 2 that it would be “unacceptable if the rights to produce and market that vaccine were subsequently handed over to a pharmaceutical manufacturer through an exclusive license with no conditions on pricing or access, allowing the company to charge whatever it would like and essentially selling the vaccine back to the public who paid for its development.”

But many Republicans opposed adding language to the bill that would restrict the industry’s ability to profit, arguing that it would stifle research and innovation. And although Azar, who served as the top lobbyist and head of U.S. operations for the pharmaceutical giant Eli Lilly before joining the Trump administration, assured Schakowsky that he shared her concerns, the bill went on to enshrine drug companies’ ability to set potentially exorbitant prices for vaccines and drugs they develop with taxpayer dollars.

The final aid package not only omitted language that would have limited drug makers’ intellectual property rights, it specifically prohibited the federal government from taking any action if it has concerns that the treatments or vaccines developed with public funds are priced too high.

“Those lobbyists deserve a medal from their pharma clients because they killed that intellectual property provision,” said Posner, who added that the language prohibiting the government from responding to price gouging was even worse. “To allow them to have this power during a pandemic is outrageous.”

The truth is that profiting off public investment is also business as usual for the pharmaceutical industry. Since the 1930s, the National Institutes of Health has put some $900 billion into research that drug companies then used to patent brand-name medications, according to Posner’s calculations. Every single drug approved by the Food and Drug Administration between 2010 and 2016 involved science funded with tax dollars through the NIH, according to the advocacy group Patients for Affordable Drugs. Taxpayers spent more than $100 billion on that research.

Among the drugs that were developed with some public funding and went on to be huge earners for private companies are the HIV drug AZT and the cancer treatment Kymriah, which Novartis now sells for $475,000.

In his book “Pharma,” Posner points to another example of private companies making exorbitant profits from drugs produced with public funding. The antiviral drug sofosbuvir, which is used to treat hepatitis C, stemmed from key research funded by the National Institutes of Health. That drug is now owned by Gilead Sciences, which charges $1,000 per pill — more than many people with hepatitis C can afford; Gilead earned $44 billion from the drug during its first three years on the market.

“Wouldn’t it be great to have some of the profits from those drugs go back into public research at the NIH?” asked Posner.

Instead, the profits have funded huge bonuses for drug company executives and aggressive marketing of drugs to consumers. They have also been used to further boost the profitability of the pharmaceutical sector. According to calculations by Axios, drug companies make 63 percent of total health care profits in the U.S. That’s in part because of the success of their lobbying efforts. In 2019, the pharmaceutical industry spent $295 million on lobbying, far more than any other sector in the U.S. That’s almost twice as much as the next biggest spender — the electronics, manufacturing, and equipment sector — and well more than double what oil and gas companies spent on lobbying. The industry also spends lavishly on campaign contributions to both Democratic and Republican lawmakers. Throughout the Democratic primary, Joe Biden has led the pack among recipients of contributions from the health care and pharmaceutical industries.

Big Pharma’s spending has positioned the industry well for the current pandemic. While stock markets have plummeted in reaction to the Trump administration’s bungling of the crisis, more than 20 companies working on a vaccine and other products related to the new SARS-CoV-2 virus have largely been spared. Stock prices for the biotech company Moderna, which began recruiting participants for a clinical trial of its new candidate for a coronavirus vaccine two weeks ago, have shot up during that time.

On Thursday, a day of general carnage in the stock markets, Eli Lilly’s stock also enjoyed a boost after the company announced that it, too, is joining the effort to come up with a therapy for the new coronavirus. And Gilead Sciences, which is at work on a potential treatment as well, is also thriving. Gilead’s stock price was already up since news that its antiviral drug remdesivir, which was created to treat Ebola, was being given to Covid-19 patients. Today, after Wall Street Journal reported that the drug had a positive effect on a small number of infected cruise ship passengers, the price went up further.

Several companies, including Johnson & Johnson, DiaSorin Molecular, and QIAGEN have made it clear that they are receiving funding from the Department of Health and Human Services for efforts related to the pandemic, but it is unclear whether Eli Lilly and Gilead Sciences are using government money for their work on the virus. To date, HHS has not issued a list of grant recipients. And according to Reuters, the Trump administration has told top health officials to treat their coronavirus discussions as classified and excluded staffers without security clearances from discussions about the virus.

Former top lobbyists of both Eli Lilly and Gilead now serve on the White House Coronavirus Task Force. Azar served as director of U.S. operations for Eli Lilly and lobbied for the company, while Joe Grogan, now serving as director of the Domestic Policy Council, was the top lobbyist for Gilead Sciences.

 

 

 

Confronting a national emergency over coronavirus

https://mailchi.mp/325cd862d7a7/the-weekly-gist-march-13-2020?e=d1e747d2d8

Image result for national emergency

President Trump declared a national emergency today, in response to the growing spread of coronavirus across the country. The administration had come under sharp criticism for its sluggish response to the coronavirus crisis, in particular the widespread shortage of tests. Dr. Antony Fauci, director of the National Institute of Health’s infectious disease branch, told Congress on Thursday that the government’s response on testing was “not really geared to what we need right now…That’s a failing. Let’s admit it.”

In response, the administration today announced a series of emergency steps to increase testing capacity, turning to private labs to support the effort. The emergency status frees up $50B in federal emergency funding. Trump also announced that the Health and Human Services (HHS) Secretary will be able to waive regulations around telemedicine licensing, critical access hospital bed requirements and length of stay, and other measures to provide hospitals with added flexibility. House Speaker Nancy Pelosi and Treasury Secretary Steven Mnuchin have negotiated a sweeping aid package that would strengthen safety net programs, and offer sick leave for American workers affected by the virus.

Meanwhile, the American economy likely entered a recession, as consumers continued to pull back on spending on airline travel, entertainment, and other discretionary areas, while financial markets experienced the worst one-day drop in more than 30 years. Many school districts and universities shut down and announced plans to convert to online instruction for the foreseeable future. Employers imposed broad travel restrictions on their employees, moved to teleworking where possible, and even began to lay off workers as demand for services cratered. Shoppers stocked up on staples, cleaning supplies, and (inexplicably) toilet paper, as shelves ran bare in many stores.

Epidemiologists and disease experts urged broad adoption of “social distancing”, restricting large gatherings and reducing the ability of the virus to spread person-to-person. The objective: “flattening the curve” of transmission, so that the healthcare delivery system does not become overwhelmed as the virus spreads exponentially.

 

 

 

 

Another new first for CRISPR

https://www.axios.com/newsletters/axios-vitals-38324a12-c0f6-4610-bbc9-675192c94df1.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Image result for crispr gene editing

For the first time, scientists have used the gene-editing technique CRISPR inside the body of an adult patient, in an effort to cure congenital blindness, Bryan reports.

Why it matters: CRISPR has already been used to edit cells outside a human body, which are then reinfused into the patient.

  • But the new study could open the door to using gene editing to treat incurable conditions that involve cells that can’t be removed from the body, like Huntington’s disease and dementia.

Details: The research was sponsored by biotech companies Editas Medicine of Cambridge, Massachusetts, and Allergan of Dublin, Ireland, and was carried out at Oregon Health and Science University.

  • Scientists led by Eric Pierce of Harvard Medical School injected microscopic droplets carrying a benign virus into the eye of a nearly blind patient suffering from the genetic disorder Leber congenital amaurosis.
  • The virus had been engineered to instruct the cells to create CRISPR machinery. The hope is that CRISPR will edit out the genetic defects that cause blindness, restoring at least some vision.
  • “We literally have the potential to take people who are essentially blind and make them see,” Charles Albright, chief scientific officer at Editas, told AP.

“It gives us hope that we could extend that to lots of other diseases — if it works and if it’s safe,” National Institutes of Health director Francis Collins told NPR.

 

 

 

 

Moffitt Cancer Center CEO, center director step down; conflicts of interest cited

https://www.beckershospitalreview.com/hospital-executive-moves/moffitt-cancer-center-ceo-center-director-step-down-conflicts-of-interest-cited.html?origin=CEOE&utm_source=CEOE&utm_medium=email

Related image

Tampa, Fla.-based H. Lee Moffitt Cancer Center & Research Institute on Dec. 18 accepted the resignations of President and CEO Alan F. List, MD, and Thomas Sellers, an executive vice president and center director at Moffitt, the cancer center announced.

In a news release, Moffitt said the resignations were due to violations of conflict-of-interest rules through the work the center director and CEO did in China. An internal compliance review led up to the resignations.

“Moffitt initiated an internal review of team members’ collaborations with research institutions in China after the National Institutes of Health warned all its grant recipients of foreign efforts to influence or compromise U.S. researchers,” Moffitt said. “Moffitt found several compliance violations that also prompted separation of four additional researchers.”

Timothy Adams, Moffitt’s board chairman, will become interim CEO and president.

The Tampa Bay Times reports that the compliance violations were primarily associated with cancer center employees’ personal involvement in China’s “Thousand Talents” program, which aims to recruit global researchers and academics. 

Mr. Adams said in the news release: “At Moffitt, we pride ourselves not only on our lifesaving research and world-class patient care, but also on transparency and integrity among all our employees. This was an unfortunate but necessary decision.”

“Going forward, this will not damage the future of our research or the care of our patients. We will continue to be careful stewards of the public money entrusted to us for cancer research. Moffitt is proud to have 7,000 of the finest medical professionals in the world fighting every day to treat and cure cancer. That is what mattered yesterday, and that is what will matter tomorrow,” he added.

Former Florida House Speaker H. Lee Moffitt, the cancer center’s namesake, also addressed the matter, saying in the news release: “This great institution did its job. We listened to the warnings from NIH, conducted a proactive review, and took strong action when it was needed.”

Dr. List, who previously was Moffitt’s executive vice president and physician-in-chief as well as chief of the malignant hematology division, could not immediately be reached by the Times for comment.

Moffitt continues to conduct a review, including examining its research and education partnership with China’s Tianjin Medical University Cancer Institute and Hospital. Moffitt said nothing indicates that the cancer center’s research was compromised or patient care affected.