martes, 21 de abril de 2020

What do contractors, magazine publishers and a Mohawk tribe have in common?

D.C. Diagnosis
Nicholas Florko

Catching up with the NIH director

My colleague Lev Facher has a new interview with NIH Director Francis Collins. They talk about all the hot topics, from Trump’s #FireFauci tweet to growing calls for the NIH to require drug makers to affordably price any drug developed using NIH science. 
Spoiler alert: Collins’ answer on the latter topic isn’t going to satisfy drug pricing advocates, like Knowledge Ecology International, which has been locked in a multi-year fight with Collins over the NIH’s role in the drug pricing debate. They argue the government has the right to limit the prices drug makers can charge, but they’ve been unwilling to do so. NIH says it doesn't have nearly as much power as advocates say it does.
“The NIH has too good of a reputation,” KEI’s Executive Director Jamie Love told me late last month. “They’ve completely ignored all the pricing problems.” 
The fight is only likely to heat up: The NIH unveiled a partnership last week with 16 drug companies to speed the development of potential coronavirus treatments.
Check out Lev’s new interview here.

Coronavirus means lots of business for K Street
A number of companies at the center of the coronavirus pandemic response are hiring new lobbyists. Some of the companies, like 3M and General Motors, are household names with established presences on Capitol Hill. Others, like the ventilator manufacturer Vyaire Medical and the drug developer Arcturus are hiring lobbyists for the first time. For more on how coronavirus is impacting K Street, check out Lev’s new story here
More coronavirus coverage from STAT
The scoop that moved markets: STAT’s biotech braintrust got an early look at the progress of Gilead’s Remdesivir trial.

A Covid-19 test personally touted by Trump isn’t performing as well as expected. STAT has the scoop. 

Why the world’s top infectious disease experts seriously underestimated the Covid-19 threat, told by the STAT reporter who was one of the first to spot the looming pandemic.

Novartis is launching a study on Trump’s favorite, as-yet unproven Covid-19 treatment.

Why experts say a widely-used model for predicting Covid-19 deaths shouldn’t be relied on by policy makers.

Inside Trump’s plan for reopening the U.S.

Adam Feuerstein has some honest words for a company cashing in on coronavirus.

Curious what we know and don’t know about Covid-19 immunity? STAT’s got the details. 


Did we mention it’s lobbying disclosure day?

The Pharmaceutical Research and Manufacturers of America spent $9 million dollars lobbying Congress in the first four months of 2020, according to federal disclosures published late Monday. The lobbying group, known for its prowess in Washington, lobbied on no less than 100 bills so far this year, including at least seven dealing with the coronavirus. However, the group still spent $900,000 less than this time last year. 
PhRMA isn’t the only one spending less than last year. Genentech, which spent a record $2.95 million on lobbying in the first quarter of 2019, dropped its spending to $2.71 million in 2020. Merck cut back from $2.74 million during Q1 in 2019 to $2.17 in 2020, and Eli Lilly shaved just shy of $100,000 off its lobbying budget for the same period: It spent $1.29 million this quarter. 
The drop in spending could be an early sign that the troubles that were facing the drug industry in early 2019, namely bipartisan ire over high drug prices, have subsided. (Remember it was just 14 months ago that pharma CEOs were unceremoniously dragged before a Senate committee.)
Some other fun lobbying tidbits: It’s not just drug makers getting in on the action: take the Associated General Contractors of America, the Human Rights Campaign, and the National Venture Capital Association, all of whom disclosed they lobbied on drug pricing this quarter. Even the Magazine Publishers of America is on the list; They spent some time lobbying on bills that would take away tax write-offs for drug ads. 
P.S.: Remember the Saint Regis Mohawk Tribe, which courted controversy nearly three years ago when it claimed ownership of Allergan’s patent rights to the dry-eye drug Restasis? The tribe is still retaining a top D.C. law firm, Holland & Knight, to lobby on drug pricing issues, among a host of other topics — despite the fact that the federal courts ruled in 2018 that Allergan’s gambit didn’t pass legal muster.


Is the drug industry’s reputation improving?

Yes. At least according to a new survey of 1850 patient groups around the globe. The annual survey from PatientView, a UK-based research firm focusing on patient groups, found that 46% of patient groups surveyed have an “excellent” or “good” view of pharma — up from 41% last year. STAT’s Ed Silverman is quick to point out, however, that many of these patient groups receive sizable funding from drug makers, which could skew their views. 
(And hey, if money can only buy you a 46% approval rating, maybe money really can’t buy everything.)
And a counterpoint: Patients for Affordable Drugs, the patient group that prides itself on taking no money from the pharmaceutical industry, is out with a new blog today accusing the drug industry of being “uninterested in fighting infectious diseases for decades.” The blog is the group’s latest effort in a campaign calling for restrictions on how much drug companies can charge for potential Covid-19 treatments. Drug makers have denied these claims, arguing the industry has made “decades-long investments” in infectious diseases which have “prepared the industry to act swiftly to respond to the public health crisis.”


The latest coronavirus ask: Home infusion!

More than 150 health groups, including some of the nation's largest hospital systems, are out with a new letter to CMS Administrator Seema Verma that calls on the agency to allow widespread home infusion for drugs that are typically administered in doctors offices or hospitals. More specifically, they’re asking for CMS to issue a so-called 1135 waiver  to relax certain federal restrictions during the pandemic. The letter follows a similar April 3 request from 30 senators, led by Sen. Tim Scott (R-S.C.), and a April 10 request from 181 representatives, led by Rep. Eliot Engel (D-N.Y.)
It’s the latest and most visible push from infusion providers, which have complained for two years about what they argue are subpar and potentially unlawful home infusion reimbursement policies. The National Home Infusion Association is currently suing CMS over an earlier policy that required providers to be physically present in a patient’s home during an infusion in order to get paid. The group is also pushing a separate bill that would revoke that requirement.

STAT stories you may have missed 

Minnesota is the first state with an emergency insulin fund. Getting there wasn’t easy. Can other states replicate the model? 
STAT’s Matt Herper digs into the latest promising data for Bristol Myers Squibb’s latest cancer drug. 
After years of decline, prescriptions for insomnia and depression are spiking. 
The latest in the ongoing controversy over FDA’s use of so-called surrogate endpoints. 
In this week’s episode of our podcast, The ReadoutLoud, we discuss President Trump's move to freeze funding for the WHO and other surreal headlines coming out of the Capitol this month.
Opinion: The Covid-19 pandemic has forced many health care providers into an arranged marriage with telemedicine. For some of us, there is the potential for true love

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