Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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PhRMA Lobbying Pays Off Again: Senate Panel Rejects Proposal to Allow Importation of Rx Drugs from Canada

PhRMA Lobbying Pays Off Again: Senate Panel Rejects Proposal to Allow Importation of Rx Drugs from Canada | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A Senate panel on Thursday rejected a Democratic effort to make it easier for Americans to purchase medications from Canada, where prescription drugs are typically sold at significantly cheaper prices than in the United States.

 

The Senate Health, Education, Labor and Pensions Committee voted 13-10 along mostly party lines to kill the proposal, which was offered by Sen. Bernie Sanders (I-Vt.) as an amendment to bipartisan legislation that would reauthorize Food and Drug Administration programs.

 

Opponents of easing federal laws on drug importation, including the pharmaceutical lobby, say it could expose Americans to unsafe medicines that haven’t been vetted by U.S. regulators.

 

“This would put Americans at risk of counterfeit and substandard drugs,” Sen. Orrin Hatch (R-Utah) said at the markup. “There’s no way for Americans to ensure the drug being dispensed in a Canadian pharmacy is the same drug as what the doctor prescribed.”

 

Sanders said the amendment has provisions to ensure drugs imported from Canada are safe. Opposition to the proposal, he said, is being fueled by lobbying from the drug industry, not out of concern for drug safety.

 

“This amendment is about whether or not we have the courage to stand up to an industry which has spent more than $3 billion lobbying since 1998 to make certain that we pay the highest prices in the world for prescription drugs,” he said.

 

The Pharmaceutical Research and Manufacturers of America, the industry’s trade group, said it has concerns about importation proposals in Congress due to safety issues, pointing to counterfeit drugs that reached the United States from China via Mexico and Canada.

 

“Even Canada has said it does not and would not be able to guarantee that U.S. citizens would receive products that are safe, effective and of high quality,” PhRMA spokesman Andrew Powaleny said. “Guaranteeing patient safety is crucial, and we must have policies that ensure patients safely have access to the medicines they need.”

 

Further Reading:

Bernie to Trump: “Talk is Cheap.” Stand Up to Big Pharma! Support Importing Drugs from Canada!: http://sco.lt/83osEr

Senators Start a New Effort to Allow Importation of Certain Drugs from Canada. Will Trump Play Security Card?: http://sco.lt/644f0D

Pharma Guy's insight:

This is part of Sanders’ campaign to thwart president Trump’s agenda. However, Bernie is up against a much stronger opponent than Trump – the drug industry lobby headed by PhRMA, which is now firmly in Trump’s camp (read, for example, Big Pharma Struggles to Distance Itself from "Price Gouging" Small Pharma: http://bit.ly/2ra4Pd1).

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Bernie to Trump: “Talk is Cheap.” Stand Up to Big Pharma! Support Importing Drugs from Canada!

Bernie to Trump: “Talk is Cheap.” Stand Up to Big Pharma! Support Importing Drugs from Canada! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump and other Republicans have talked about the greed of the pharmaceutical industry. Recently, Trump said (rightly) that Big Pharma is “getting away with murder.” But talk is cheap. The question is: Will Republicans really have the guts to join me and many of my colleagues in standing up to the drug companies to fight for American consumers and end the disgrace of having our country pay by far the highest prescription drug prices in the world? If Trump believes what he has said about the industry, he will rally his party to help save American lives. Here’s why.

 

The five largest drug manufacturers made more than $50 billion in profits in 2015. Meanwhile, nearly 1 out of 5 Americans could not afford the medicine they were prescribed. The result: Millions of Americans became sicker, and some ended up in emergency rooms at great cost. Others unnecessarily lost their lives.

 

It is beyond comprehension that while Americans are suffering and dying because they cannot afford the medications they need, the 10 highest-paid chief executives in the pharmaceutical industry collectively made $327 million in 2015. These executives get richer while Americans die. That’s not acceptable.

 

The root of this problem is that we are the only major country not to negotiate drug prices with the pharmaceutical industry. You can walk into a pharmacy today and the price could be double or even triple what you paid for the same medicine a year ago, and there are no legal barriers in place to stop these arbitrary increases. Pharmaceutical corporations can raise prices as high as the market allows. If people die, it is not their concern. If people get sicker, it is not a problem for them.

 

Yet, 50 miles from my home in Vermont, the same medications manufactured by the same companies in the same factories are available for a fraction of the price. A 90-day supply of Januvia, which treats diabetes, is $505 in the United States but $204 across the northern border. A 90-day supply of Advair, used in asthma inhalers, costs about $222 in Canada and approximately $464 in the United States. A year’s supply of one of the most important treatments for advanced prostate cancer, Xtandi, is sold for about $30,000 in Canada. Patients here pay about $130,000.

 

Outrageously, our government, and therefore U.S. taxpayers, paid for research that led to Xtandi’s discovery.

 

This state of affairs is unacceptable. Until recently, Trump agreed. Yet after one meeting with pharmaceutical lobbyists, the president started reversing course. Instead of negotiating drug prices down, he talked about cutting taxes for drug companies that already make billions on the backs of American consumers.

 

Again, this cannot continue. That is why I am introducing legislation to end this insanity, allowing Americans to buy the same drugs they receive now, but from Canada, at far lower prices.

Pharma Guy's insight:

Further Reading: “Sanders to Challenge Trump to Support Allowing Medicare to Negotiate Drug Prices”; http://sco.lt/8PLedN

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Bernie Sanders Explains Why U.S. Spends So Much on Healthcare: Waste, Inefficiency & #Pharma Profits

Bernie Sanders Explains Why U.S. Spends So Much on Healthcare: Waste, Inefficiency & #Pharma Profits | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Today the United States spends far more per capita on health care than any other nation. According to the latest information, we spend $ 3.2 trillion a year on health care— about $ 10,000 for every man, woman, and child. In 2013, we spent 17.1 percent of our GDP on health care. This was almost 50 percent more than the next highest spender, France, and double what the United Kingdom spent.

 

The irrationality of the current system can thus be seen not just in the profit margins and outrageously high compensation packages of CEOs in the insurance and pharmaceutical industries, but, more significantly, in the huge amount of waste and inefficiencies inherent in an enormously complicated system designed to maximize profit rather than provide high-quality and cost-effective health care.

 

While the five largest drug companies made a combined $ 50 billion in profits last year, one out of five Americans between the ages of nineteen and sixty-four were unable to fill the prescriptions their doctors wrote.

 

One of the reasons the pharmaceutical industry makes huge profits is pretty simple: Unlike every other major country on earth, all of which negotiate prices with the pharmaceutical industry, here in the U.S. drug companies can charge any price they want. And so they do. You can walk into your pharmacy tomorrow to get a refill of the same medicine that you have used for twenty years, and the price could be double what it was when you got your last refill six months before. And there is not a thing you can do about it.

 

It might have something to do with the fact that the pharmaceutical industry is one of the most politically powerful industries in the country and spends endless amounts of money on lobbying and campaign contributions. The pharmaceutical industry has spent more than $ 3 billion on lobbying since 1998. This is $ 1 billion more than the insurance industry, which came in second place in lobbying expenditures. The pharmaceutical industry, because of its great power, rarely loses legislative fights. It has effectively purchased the Congress, and there are Republican and Democratic leaders who support its every effort.

 

The answer has everything to do with the power and greed of the pharmaceutical industry, and a health care system more concerned about profits than about the needs of the American people

Pharma Guy's insight:

Meanwhile, "Trump Trumps Bernie Sanders: Promises Free Rx Drugs to All!"; http://sco.lt/82V0Rl 

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Sanders to Pfizer and Allergan: "I Don't Want Your Damn Merger!"

Sanders to Pfizer and Allergan: "I Don't Want Your Damn Merger!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sanders has asked the Treasury to try to undermine the deal by removing some of the tax strategies, including "hopscotch loans" that companies use after a so-called tax inversion like this one to return offshore profits to shareholders, according to his letter to the department.

"Blocking this inversion would not only be sound fiscal policy, it would also act as a strong deterrent to other companies that are contemplating similar tax scams," Sanders, the ranking member of the Senate Budget Committee, said in his letter.

He pointed to estimates from a tax fairness group stating that stopping the merger would save the U.S. about $35 billion in lost taxes, although some economists have questioned that estimate.

The Treasury, which already has twice made rule changes in an effort to make such deals less palatable, acknowledged receiving the letter and said the department would respond "in due course," The Washington Post reported.

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Califf a "Shoe-in" to be Approved for FDA Commish

Califf a "Shoe-in" to be Approved for FDA Commish | Pharmaguy's Insights Into Drug Industry News | Scoop.it
He has been trying to satisfy Democratic concerns that he's too close to pharmaceutical companies.


He has had to spend time addressing concerns from Democratic committee members — especially Senator Bernie Sanders of Vermont, the presidential candidate, and Senator Elizabeth Warren of Massachusetts. They’ve grilled Califf on his close ties to pharmaceutical companies and the impact of their funding on research he oversaw at Duke. Sanders, who has been out on the campaign trail, isn’t expected to show up for the vote.


In written responses to follow-up questions from Warren, Califf said he and his Duke Center did not permit its pharmaceutical industry funders to influence the outcome of the studies — although he acknowledged their input into the design.


Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices."; http://bit.ly/1lUzR4I

 

Pharma Guy's insight:

Remember when FDA Commissioner Andrew von Eschenbach was announced that he planned to resign as FDA commish in 2009? A disgruntled FDA staffer rose abruptly from his seat about 12 feet away, reared his right arm and fired a shoe at the commissioner’s head while shouting: “This is a gift from the entire FDA staff; this is the farewell kiss, you dog!”; http://bit.ly/1E74Dv 

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Bernie Sanders Blasts FDA Commish Nominee Califf on Drug Reimportation

Senator Bernie Sanders laid into FDA Commissioner nominee Robert Califf during yesterday's Senate hearing. Here's a snippet of his comments regarding reimportation of Rx drugs as a means to lower drug prices - an issue of importance to 91% of voters (for more on that, read this).

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ROFL! @MartinShkreli Accuses @BernieSanders of "Price Gouging."

ROFL! @MartinShkreli Accuses @BernieSanders of "Price Gouging." | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Turing CEO Martin Shkreli tweeted screenshots of two automated emails he received from Bernie Sanders’ campaign. The first asked for a $3 donation; the second, which arrived the next day, asked for $25.66.


In a follow up tweet, Shkreli wrote: “Bernie Sanders…raised the donation requested from his supporters by 755% in one day. Price gouging,” an attempt to paint the presidential candidate as a hypocrite after refusing to accept the price gouging CEO’s donation.

Pharma Guy's insight:

This is just one of the reasons why I follow @MartinShkreli on Twitter. Learn about the other reasons here: http://bit.ly/1M0dOza 

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Califf Is Not the Person to Lead FDA, Says Bernie Sanders

Califf Is Not the Person to Lead FDA, Says Bernie Sanders | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“At a time when millions of Americans cannot afford to purchase the prescription drugs they need, we need a new leader at the FDA who is prepared to stand up to the pharmaceutical companies and work to substantially lower drug prices. Unfortunately, I have come to the conclusion that Dr. Califf is not that person,” Sanders said after speaking with the nominee. Califf’s confirmation will come before the Senate health committee, which Sanders sits on.

Pharma Guy's insight:

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis. He also receives as much as $100,000 a year in consulting fees from some of those companies, and from others, according to his 2014 conflict of interest disclosure [pdf]. In an interview with TIME, Califf estimates that less than half of his annual income comes from research money provided by the pharmaceutical industry, though he says he is not certain because he doesn’t tend to distinguish between industry and government research funding. http://bit.ly/1L3DUno 

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Pharma Showers West Virginia with Oxycontin: 433 Pills for Every Man, Woman, & Child!

Pharma Showers West Virginia with Oxycontin: 433 Pills for Every Man, Woman, & Child! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a town hall televised by MSNBC Monday night, Sen. Bernie Sanders called out the pharmaceutical industry for pumping addictive opioids into small, rural towns—parts of the country already devastated by disappearing jobs and crumbling infrastructure.

 

“I’ve got to tell you, I’m not a great fan of the pharmaceutical industry in general,” Sanders said, according to the Bluefield Daily Telegraph. “For them to make to make billions in profits by getting young people addicted and ruining their lives … we have to start holding them accountable.”

 

The event was held in McDowell County, West Virginia, which has one of the highest per capita fatal drug overdose rates in the country. Not by coincidence, West Virginia coal country was the target of a concerted push by the pharmaceutical industry to bring addictive painkillers to poor, rural regions.

 

In December, the Charleston Gazette-Mail reported that out-of-state pharmaceutical companies went to extreme lengths to sell drugs in West Virginia, including McDowell County. In one case, just one pharmacy in a town of 392 received 9 million hydrocodone pills over the course of two years.

 

“In six years, drug wholesalers showered the state with 780 million hydrocodone and oxycodone pills, while 1,728 West Virginians fatally overdosed on those two painkillers,” the investigation found. “The unfettered shipments amount to 433 pain pills for every man, woman and child in West Virginia.”

 

Further Reading:

  • “Secret Internal Sales Documents Reveal Abbott's Despicable "Crusade" to Sell OxyContin” in West Virginia: http://sco.lt/71CKvZ
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Sanders to Challenge Trump to Support Allowing Medicare to Negotiate Drug Prices

Sanders to Challenge Trump to Support Allowing Medicare to Negotiate Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sen. Bernie Sanders (I-Vt.) on Tuesday said he will introduce legislation allowing Medicare to negotiate drug prices and called on President-elect Donald Trump to support the proposal.

 

"If Mr. Trump is serious about taking on Pharma, if Mr. Trump is serious about having Medicare ... negotiate prescription drug prices with the pharmaceutical industry, we are going to have very shortly very significant legislation to do just that," Sanders told reporters.

 

"I would hope that Mr. Trump would join us and support that legislation."

 

Trump indicated throughout the campaign that he would support allowing the government to negotiate drug prices and said last week that the pharmaceutical industry is "getting away with murder" because of what it charges the government.

 

Sanders did not say when he would be introducing his legislation, which is also expected to allow for importing drugs from Canada and other countries.

 

Further Reading:

  • “Cory Booker and 12 Other Dems Just Stopped Bernie Sanders’ Amendment to Lower Prescription Drug Costs”; http://sco.lt/6FEFw9
Pharma Guy's insight:

Feel the Bern!

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Bernie Sanders Calls Lilly & Novo #pharma a"Greedy" for Raising Prices of Insulin Drugs

Bernie Sanders Calls Lilly & Novo #pharma a"Greedy" for Raising Prices of Insulin Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Despite his defeat in the primary, popular Vermont Senator Bernie Sanders continues to lend his star power to the principals of the political revolution, taking aim Tuesday at a pharmaceutical company that raised the price of a life-saving insulin drug—and Wall Street is taking notice.

Tuesday morning, Sanders criticized pharmaceutical company Eli Lilly, which raised the price of its insulin drug Homolog (sic) by 700 percent in 20 years when adjusted for inflation.

In a tweet to his 2.7 million Twitter followers, the Vermont Senator posted a Washington Post graph showing the cost of Homolog has risen from $21 to $255 since 1996. Sanders blamed “the drug industry’s greed” for profiting off those in need.

Pharma Guy's insight:

Is Bernie short-selling the stock of pharma companies he criticizes?

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Senate Committee Clears Califf But Bernie Sanders May Throw Shoe

Senate Committee Clears Califf But Bernie Sanders May Throw Shoe | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Two senators, including presidential candidate Bernie Sanders, threatened to hold up his nomination.


The Senate Health, Education, Labor and Pensions Committee on Tuesday voted unanimously in favor of Dr. Robert Califf to become commissioner of the FDA. Two senators have threatened to block the former Duke cardiologist's nomination, however. 


Sen. Lisa Murkowski (R-Ala.) said she would hold up a vote on the Senate floor, the next and final step in Califf's nomination, until the FDA addresses her concerns about the labeling of genetically modified salmon. 


Sen. Bernie Sanders(I-Vt.), too, opposes the nomination and is considering a hold—he has cited Califf's ties to the pharmaceutical industry, particularly his work as a consultant for drugmakers. Sanders was not present at the committee hearing. Open Payments data show that Califf received over $29,000 in consulting fees, food and travel from drugmakers in 2014.

Pharma Guy's insight:

Read:

  • "FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft "Cures" Legislation"; http://sco.lt/7feuEz 
  • "Bernie Sanders to Robert Califf: 'You're Not the One'."; http://sco.lt/5yQxqT 
  • "NYT Has Questions for President Obama’s Nominee to lead the F.D.A."; http://sco.lt/9LrfNp 
  • "Califf Removes His Name as Author of Scientific Paper Critical of FDA"; http://sco.lt/8dwRer 


Public Citizen said: "It should be unimaginable that the most senior Food and Drug Administration (FDA) officials would collude with the lead medical device trade association to write legislation to weaken the agency’s regulatory oversight and approval standards for medical devices. But that is exactly what appears to have happened. The result is contained within the House-passed 21st Century Cures Act – more accurately known as the False Cures Act – which would eviscerate the already far-too-weak safety rules for medical devices."; http://bit.ly/1lUzR4I

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Pharma to Sanders: "No Money for you, but Clinton? Yes!"

Pharma to Sanders: "No Money for you, but Clinton? Yes!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sen. Bernie Sanders (I-Vt.) has criticized Democratic presidential rival Hillary Clinton for taking millions from pharmaceutical companies in a new fundraising email that frames her as beholden to the industry.  


"I don't go around asking millionaires and billionaires for money. You know that. I don't think I'm going to get a whole lot of contributions from the health care and pharmaceutical industries," he wrote in the note from Wednesday.
 
Sanders went on to remind supporters that he turned down a donation from Martin Shkreli, the CEO who raised prices on AIDS medications and is now charged with financial crimes. Both Sanders and Clinton repudiated Shkreli when that decision went public. 
 
Then Sanders shifted toward a critique on Clinton.
 
"Secretary Clinton, on the other hand, has received millions of dollars from the health care and pharmaceutical industries, a number that is sure to rise as time goes on," he wrote, arguing that Clinton has raised more money from the healthcare industry than the top three Republican candidates combined. 
 
"Now, and let's not be naive about this, maybe they are dumb and don't know what they are going to get? But I don't think that's the case, and I don't believe you do either."
 
Clinton has raised about $1.1 million from the pharmaceuticals or health products industries this cycle, according to data from Open Secrets. That's the 14th highest total from any industry or group that has given to Clinton, according to Open Secrets. The group giving the most money to Clinton — $7.66 million — is retirees.

In an email, he criticized Clinton for those donations.

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Bernie Sanders to Robert Califf: "You're Not the One."

Bernie Sanders to Robert Califf: "You're Not the One." | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Under sharp questioning from Democratic Senator Elizabeth Warren of Massachusetts, Califf promised to strike the right balance between approving new drugs quickly and making sure they’re safe.


“I think if you look at my record, I’ve never been a proponent of lowering standards. If anything, I’ve argued for raising them,” he told Warren. “That doesn’t mean we couldn’t be quicker in some cases.”


But Sanders — who had previously announced he wouldn’t support Califf — grilled the potential FDA commissioner in an unsuccessful attempt to get him to support reimportation of cheaper prescription drugs from other countries and allowing Medicare to negotiate lower drug prices, two key proposals in Sanders’ plan to rein in drug costs.


“We all want great medicines to come onto the market, and I respect the work you have done. But at the end of the day, people are dying … because we have been extraordinarily weak in taking on the pharmaceutical industry,” Sanders told Califf. “I believe we need a commissioner who is going to stand up to the pharmaceutical industry, so I have to say to you with regret you are not that person.”


Most of the questions Califf received from Republicans and Democrats on the committee were polite and restrained, and he’s still expected to win confirmation. But his past financial support from the pharmaceutical industry quickly became the running theme of the questions from Democratic senators.

Pharma Guy's insight:

Sanders also brought up other issues that prevent the U.S. from lowering drug prices; e.g., pharma lobbying (In 2014, the pharmaceutical industry spent $250 million on lobbying and campaign contributions and employed some 1,400 lobbyists. “Do you think that type of expenditure has any impact on the fact that we pay the highest prices in the world for prescription drugs?” Sanders asked Califf.) and Medicare's inability to negotiate lower drug prices (see here: http://sco.lt/7igOmn). Listen to the hearing here: http://1.usa.gov/1MQk01x 

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Bernie Sanders Scorns Donation from Pharma Bro Martin Shkreli

Bernie Sanders Scorns Donation from Pharma Bro Martin Shkreli | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The campaign said they would not keep money from a "poster boy for drug company greed.”


Turning Pharmaceuticals drew national scorn after it raised the price of a unique treatment for a rare parasitic infection by 4,000 percent overnight, a move Sanders described as “blatant profiteering.”


Shkreli said he donated the money to Sanders in order to try to set up a meeting with the self-proclaimed Democratic socialist to explain his side of the story.


“I think it’s cheap to use one person’s action as a platform without kind of talking to that person,” Shkreli said in an interview with Stat on Thursday. “He’ll take my money, but he won’t engage with me for five minutes to understand this issue better.”


He accused Sanders of “talking out of his rear end so that he gets some votes.”

Pharma Guy's insight:

Shkreli donated $2,700. Whoa! Big spender!


The Sanders campaign said it will hand over the money to a Washington-based health clinic. 

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