The Health 202: Trump may have made it easier for Biden to go after the drug industry

“This provides an opening,” said Elizabeth Fowler, executive vice president for programs at the nonpartisan Commonwealth Fund. “Maybe it’s a bargaining chip with the industry.” 

Biden likes the idea of bringing high U.S. drug prices more in line with other countries’ lower prices. 

This is the core idea in the “most favored nation” rule Trump announced on Friday. It will tie the prices of drugs in Medicare Part B to the lower prices in other developed countries, many of which negotiate those prices directly with drugmakers.

This approach of linking high-cost U.S. drugs to an international index is one that has been embraced by many Democrats. Last year, House Democrats passed a bill allowing the federal government to negotiate lower Medicare drug prices. The bill, H.R. 3, uses an index of prices in six other countries as a price ceiling for the United States.

Implemented a most favored nation rule represents a major shift in the way the federal government sets prices for drugs in the Medicare program and could result in significant payment cuts for drugmakers.

During his campaign, Biden proposed creating an independent panel to recommend prices for new drugs that lack competition and are provided through Medicare and marketplace plans. The panel would consider other countries’ prices in making its recommendations.

Yet it’s not entirely clear how the Biden administration will handle Trump’s rule.

For one thing, the Trump administration skipped the normal rulemaking process, which requires weeks for public comment. Instead, it issued what is known as an “interim final rule” a move typically only reserved for rules that need to go into place quickly. 

That could make it difficult for the Biden administration to defend the policy in court if the pharmaceutical industry sues over the rule. The rule also relies on the government’s authority to experiment with Medicare payments, but the Trump administration wrote it so broadly that it reads more like a fundamental change to the overall program. That could be another weakness drugmakers could emphasize in court.

Still, the Biden administration may decide to stick with the interim final rule. Or, it could choose to walk it back and issue its own rule laying out an international price index. Representatives for Biden didn’t respond to a question about how the president-elect will handle it.

Either way, the situation will soon be out of the hands of Trump appointees, who will be replaced by Team Biden in two months.

“These initial rules will not be finalized under the Trump administration, so the Biden team will have a chance to finalize or not finalize based on what is consistent with their view,” Andy Slavitt, administrator of the Centers for Medicare and Medicaid Services under President Barack Obama, told me.

Biden is less enthused about another Trump administration rule — this one banning drug rebates.

Trump announced another major regulation on Friday, finalizing a ban on drug rebates in the Medicare program. It is slated to go into effect on Jan. 1,

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Birx warns Trump administration ‘aggressive action’ must be taken on COVID-19

Dr. Deborah Birx, coordinator of the White House Coronavirus Task Force, wrote in an internal report shared with White House officials on Monday that the Trump administration must take “much more aggressive action” in order to curb the spread of the coronavirus.

Birx warned that “cases are rapidly rising in nearly 30 percent of all USA counties, the highest number of county hotspots we have seen with this pandemic,” The Washington Post reports. In many areas, testing is “flat or declining” but the number of cases is increasing, Birx wrote, and the country is “entering the most concerning and most deadly phase of this pandemic … leading to increasing mortality. This is not about lockdowns — it hasn’t been about lockdowns since March or April. It’s about an aggressive balanced approach that is not being implemented.”

President Trump has been claiming the U.S. is “rounding the turn” on the virus, and in the report, Birx expressly contradicts Trump, warning against huge gatherings like his campaign rallies. One administration official told the Post that Birx has been sending “urgent” messages like this for weeks, and has been pleading with Trump staffers to “ask the American people to use masks, avoid gatherings, and socially distance, basically since it became apparent that we were heading into a third surge.”

Another administration official told the Post that Birx feels “like she’s being ignored,” especially since Trump has been persuaded by his new medical adviser, radiologist Scott Atlas, that herd immunity is the way to go. Birx has been challenging Atlas in meetings, the Post reports, and has spent the last few weeks traveling to virus hot spots and asking health officials to shutter restaurants and bars and make masks mandatory. Read more at The Washington Post.

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Stanford faculty demand university sanctions for Trump adviser and faculty member Scott Atlas

Scott Atlas; Donald Trump
Scott Atlas; Donald Trump

US President Donald Trump (L) listens to White House coronavirus adviser Dr. Scott Atlas speak during a press conference in the Brady Briefing Room of the White House on September 23, 2020, in Washington, DC. MANDEL NGAN/AFP via Getty Images

This article originally appeared here on Salon.com

Scott Atlas, one of President Trump’s special coronavirus advisers and a faculty member at Stanford University’s Hoover Institution in Palo Alto, Calif., is causing a minor fracas among students and faculty at the elite university. Specifically, Atlas’ recommendations on coronavirus public health measures fly in the face of scientific consensus, faculty says — a charge that Atlas denies, and which he has threatened litigation over.  

During a Faculty Senate meeting at Stanford University late last month, the college’s president and provost were asked whether Dr. Scott Atlas should face university sanctions for positions he has taken about the novel coronavirus pandemic that go against the scientific consensus. (As the faculty noted, Atlas is a neuroradiologist, not an epidemiologist or a scholar of infectious disease.) At the meeting, similar questions were raised about the university’s relationship with the Hoover Institution, where Atlas is a senior fellow. The Hoover Institution is a conservative think tank located on Stanford’s campus that has supported a laundry list of prominent right-wing statesmen over the years, from Condoleezza Rice to Reagan Secretary of State George Shultz. 

Unsurprisingly given the politics of his employer, Atlas’ public statements tend to delight conservatives and alarm scientists who study public health and infectious diseases. Atlas recently tweeted that masks do not work to prevent infection (an unsupported claim, and one which Twitter wound up taking down for being misleading); previously, he claimed publicly that the threat of the coronavirus is greatly exaggerated. Atlas also claimed that summer civil rights protests were to blame for coronavirus outbreaks, as well as proximity to the U.S.-Mexico border, two more claims for which there is no evidence.

Despite being described by Trump as “one of the great experts of the world,” Atlas is reported to not have expertise in infectious disease mitigation or public health. Most recently, Atlas raised eyebrows last week for appearing on Russian state broadcaster RT, which is registered with the Justice Department as an agent of the Russian government.

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David Spiegel, a medicine professor and associate chair of the Department of Psychiatry and Behavioral Sciences, claimed during the late October meeting (which occurred before the RT interview) that Atlas is the “latest member of the Hoover Institution to disseminate incorrect and unscientific information about the coronavirus pandemic,” according to Stanford News. He also accused Atlas of violating the American Medical Association’s Code of Ethics and claimed that he may have additionally violated Stanford’s Code of Conduct.

University President Marc Tessier-Lavigne responded by citing the college’s Statement on Academic Freedom, although the provost acknowledged the validity of engineering professor Stephen Monismith’s concern about a New York Times report that some of Trump’s senior economic advisers had

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Top Trump adviser bluntly contradicts president on covid-19 threat, urging all-out response

A top White House coronavirus adviser sounded alarms Monday about a new and deadly phase in the health crisis, pleading with top administration officials for “much more aggressive action,” even as President Trump continues to assure rallygoers the nation is “rounding the turn” on the pandemic.



Deborah Birx wearing a suit and tie: Deborah Birx delivers remarks on the pandemic in the White House last April. (Jim Lo Scalzo/EPA-EFE/Shutterstock)


Deborah Birx delivers remarks on the pandemic in the White House last April. (Jim Lo Scalzo/EPA-EFE/Shutterstock)

“We are entering the most concerning and most deadly phase of this pandemic … leading to increasing mortality,” said the Nov. 2 report from Deborah Birx, coordinator of the White House coronavirus task force. “This is not about lockdowns — It hasn’t been about lockdowns since March or April. It’s about an aggressive balanced approach that is not being implemented.”

Birx’s internal report, shared with top White House and agency officials, contradicts Trump on numerous points: While the president holds large campaign events with hundreds of attendees, most without masks, she explicitly warns against them. While the president blames rising cases on more testing, she says testing is “flat or declining” in many areas where cases are rising. And while Trump says the country is “rounding the turn,” Birx notes the country is entering its most dangerous period yet and will see more than 100,000 new cases a day this week.

Through a spokesperson, Birx did not respond to a request for comment.

Other health experts, including Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, have warned of record surges in cases and hospitalizations as the United States records more than 9 million cases and 230,000 deaths. “We’re in for a whole lot of hurt,” Fauci told The Washington Post late Friday, predicting a long and potentially deadly winter unless there’s an “abrupt change” — prompting Trump to suggest he planned to fire the scientist after the election.

But Birx’s daily missives go further, revealing how much the administration’s internal reports are in direct conflict with Trump’s public pronouncements that downplay the seriousness of the threat and erroneously suggest few people are dying. They also speak to the increasing desperation of health officials to spotlight the risks of a pandemic that is forecast to take thousands more lives as the weather worsens unless people change their behaviors.

Still, the increasingly dire tone of her reports has gotten little traction, according to an administration official who works with Birx and spoke on the condition of anonymity to share sensitive information. “She feels like she’s being ignored,” the official said.

Birx’s message “has been urgent for weeks,” said another administration official, “as has the plea for the administration to ask the American people to use masks, avoid gatherings and socially distance, basically since it became apparent that we were heading into a third surge.”

The report hits hard on the worsening situation: “Cases are rapidly rising in nearly 30 percent of all USA counties, the highest number of county hotspots we have seen with this pandemic,” it said. “Half of the United States is

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Voters approve more of Fauci than Trump on coronavirus

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during a House Select Subcommittee on the Coronavirus Crisis hearing in Washington, D.C.

Erin Scot | Pool | Reuters

American voters overwhelmingly approve of how the country’s top infectious diseases expert, Dr. Anthony Fauci, is handling the coronavirus pandemic, according to a new CNBC/Change Research poll.

President Donald Trump gets much worse reviews.

Nationwide, 72% of likely voters said they approve of the job Fauci is doing in handling the outbreak and only 28% disapprove, the poll found. At the same time, only 41% of respondents said they approve of how Trump is managing the virus, versus 59% who disapprove.

In six battleground states, 66% of voters answered that they approve of how Fauci is handling Covid-19, versus 34% who disapprove. For Trump, 46% of swing-state respondents said they approve of how he is managing the outbreak, while 54% said they disapprove.

The poll findings came Monday, hours after the president suggested he could fire the National Institute of Allergy and Infectious Diseases director following Tuesday’s presidential election. Fauci has warned of a brutal winter looming as coronavirus cases spike around the U.S.

Trump has downplayed the outbreak, which has led to more than 230,000 American deaths as he tries to win a second term in the White House. At a campaign rally in Florida early Monday, the president signaled he could try to dismiss the infectious diseases expert during a rampaging pandemic.

Supporters gathered at the event chanted, “Fire Fauci!” The president responded, “Don’t tell anybody, but let me wait until a little bit after the election.”

Trump’s presidential election rival, Democrat Joe Biden, aimed to leverage Fauci’s popularity during his final string of campaign stops. During remarks in Cleveland on Monday, he criticized Trump for threatening to oust one of the faces of the government’s virus response.

“I’ve got a better idea: Let’s keep Dr. Fauci on the job and fire Donald Trump,” he said.

Trump could face difficulties in trying to directly fire Fauci, a civil servant whose career has spanned decades.

On Sunday, 81,400 new Covid-19 infections were reported, putting the seven-day average for U.S. cases above 81,000. On Friday, Fauci told The Washington Post that “we’re in for a whole lot of hurt” and “could not possibly be positioned more poorly” heading into the winter.

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Top Trump adviser pleads for ‘more aggressive action’ against covid-19, even as president downplays threat

A top White House coronavirus adviser sounded alarms Monday about a new and deadly phase in the health crisis, pleading with top administration officials for “much more aggressive action,” even as President Trump continues to assure rallygoers the nation is “rounding the turn” on the pandemic.



Deborah Birx wearing a suit and tie: Deborah Birx delivers remarks on the pandemic in the White House last April. (Jim Lo Scalzo/EPA-EFE/Shutterstock)


Deborah Birx delivers remarks on the pandemic in the White House last April. (Jim Lo Scalzo/EPA-EFE/Shutterstock)

“We are entering the most concerning and most deadly phase of this pandemic … leading to increasing mortality,” said the Nov. 2 report from Deborah Birx, coordinator of the White House coronavirus task force. “This is not about lockdowns — It hasn’t been about lockdowns since March or April. It’s about an aggressive balanced approach that is not being implemented.”

Birx’s internal report, shared with top White House and agency officials, contradicts Trump on numerous points: While the president holds large campaign events with hundreds of attendees, most without masks, she explicitly warns against them. While the president blames rising cases on more testing, she says testing is “flat or declining” in many areas where cases are rising. And while Trump says the country is “rounding the turn,” Birx notes the country is entering its most dangerous period yet and will see more than 100,000 new cases a day this week.

Through a spokesperson, Birx did not respond to a request for comment.

Other experts, including Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, have warned of record surges in cases and hospitalizations as the United States records more than 9 million cases and 230,000 deaths. “We’re in for a whole lot of hurt,” Fauci told The Washington Post late Friday, predicting a long and potentially deadly winter unless there’s an “abrupt change” — prompting Trump to suggest he planned to fire the scientist after the election.

But Birx’s daily missives go much further, revealing how much the administration’s internal reports are in direct conflict with Trump’s public pronouncements that downplay the seriousness of the threat and erroneously suggest few people are dying. They also speak to the increasing desperation of health officials to spotlight the risks of a pandemic that is forecast to take thousands more lives as the weather worsens unless people change their behaviors.

The increasingly dire tone of her reports has gotten little traction, according to an administration official who works with Birx and spoke on the condition of anonymity to share sensitive information. “She feels like she’s being ignored,” the official said.

Birx’s message “has been urgent for weeks,” said another administration official, “as has the plea for the administration to ask the American people to use masks, avoid gatherings and socially distance, basically since it became apparent that we were heading into a third surge.”

The report hits hard on the worsening situation: “Cases are rapidly rising in nearly 30 percent of all USA counties, the highest number of county hotspots we have seen with this pandemic,” it said. “Half of the United States is in

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Health care: Trump takes last swipe at Affordable Care Act before Election Day

The Centers for Medicare and Medicaid Services on Sunday gave the state permission to stop using the federal exchange, Healthcare.gov, for enrollment in the individual market and shift to a private sector Georgia Access Model, starting in 2023.

State officials argue that the move will give residents access to a broader array of options from web brokers, health insurance companies and agents — which will have a greater incentive to enroll consumers in coverage. They estimate the waiver will lower premiums and increase enrollment by 25,000 people.

Advocates, however, fear that it could shift healthier people to less comprehensive, non-Obamacare plans and leave those with pre-existing conditions facing higher premiums for Affordable Care Act policies. Plus, consumers could unknowingly sign up for skimpier policies.

“Consumer could end up in insurance plans that don’t cover everything they think it would cover,” said Tara Straw, senior policy analyst at the left-leaning Center on Budget and Policy Priorities.

Share your story: How have you been helped or hurt by Obamacare?

What’s more, the Georgia waiver would eliminate residents’ ability to go to a single website to see all their options. Instead, they would have to navigate a fragmented system of broker and insurers — similar to what existed prior to the landmark health reform law, Straw said. This would likely decrease coverage and raise premiums.

The waiver does not meet the federal requirements for approval, including covering as many people with the same affordable and comprehensive coverage as without the waiver, Straw said. This will open up the approval to legal challenges.

The agency opened the door for states to create alternatives to Obamacare in 2018. The Peach State, which has the nation’s third highest uninsured rate at 13.4%, is the first to seek this enhanced power to reshape its individual market.

About 433,000 Georgians were enrolled in Obamacare exchange plans, as of February, according to federal data.

The approval came on the same day as open enrollment for 2021 began and 10 days before the Supreme Court is set to hear oral arguments in a case that could bring down the law.

The Trump administration is backing a coalition of Republican-led attorneys general, including Georgia’s, who argue that Obamacare’s individual mandate was rendered unconstitutional after Congress reduced the penalty for not having insurance to zero as part of the 2017 tax cut law. As a result, the entire health reform law must fall, they argue.

Health care has taken center stage in the 2020 presidential campaign. Former Vice President Joe Biden’s campaign has hammered President Donald Trump for trying to take down the law and its protections for those with pre-existing conditions. Trump has repeatedly said he has a replacement plan that would continue those safeguards but has yet to produce one.
The administration has pursued multiple avenues to overturn the Affordable Care Act in its first term. After efforts to repeal the law in Congress failed in 2017, officials started undermining it from within, including shortening the annual enrollment period to
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Trump Suggests He Plans to Fire Fauci After Election | Health News

By Ernie Mundell and Robin Foster HealthDay Reporters

(HealthDay)

MONDAY, Nov. 2, 2020 (HealthDay News) — During a rally in Florida late Sunday night, President Donald Trump suggested that he would fire the nation’s top infectious disease expert, Dr. Anthony Fauci, as soon as the presidential election is over on Tuesday.

As he expressed frustration that the coronavirus remains prominent in the news — U.S. case counts are at their highest levels since the pandemic began — supporters in the crowd began chanting, “Fire Fauci,” the Associated Press reported.

Trump replied with this: “Don’t tell anybody, but let me wait until a little bit after the election.” He has previously expressed that he was concerned about the political blowback of removing the popular and respected doctor before Election Day. He added he appreciated the “advice” of the crowd.

Fauci, who heads up the U.S. National Institute of Allergy and Infectious Diseases, has begun to challenge the president publicly, saying that Trump has ignored his advice for containing the virus and that he hasn’t spoken with Trump in more than a month. He has also warned repeatedly that the nation is heading for a tough winter if more isn’t done soon to slow the spread of the disease which has killed more than 230,000 Americans so far this year, the AP reported.

The latest case counts suggest Fauci is right: More than 9.2 million Americans have been diagnosed with COVID-19, and the seven-day average of new daily coronavirus infections in the United States hit a new high of 81,740 on Sunday, the Washington Post reported. Record-shattering numbers of hospitalizations were also recorded in nine states: Alaska, Iowa, Missouri, Montana, Nebraska, New Mexico, Ohio, South Dakota and Utah.

“There is no way to sugarcoat it: We are facing an urgent crisis, and there is an imminent risk to you, your family members, your friends, your neighbors,” Gov. Tony Evers of Wisconsin said last week, The New York Times reported.

Evers’ state has been hard by coronavirus: More than 200 coronavirus deaths were announced last week, and as case numbers have exploded, hospitals have been strained.

But Wisconsin is not alone. The surge that started in the Upper Midwest and rural West has now spread far beyond, sending infection levels soaring in places as disparate as El Paso, Chicago and Rexburg, Idaho, according to the New York Times.

Daily reports of deaths from the virus still remain far below their spring peaks, averaging around 800 a day, but those have also started to climb, the Times reported.

States say they don’t have enough money to distribute a COVID vaccine

Meanwhile, state health officials say they are frustrated about a lack of financial support from the federal government as they face orders to prepare to receive and distribute the first doses of a coronavirus vaccine by the unlikely target date of Nov. 15, the Post reported. And these officials stress that they don’t have enough money to pay for the massive undertaking.

State

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Tests Show Genetic Signature of Coronavirus That Likely Infected Trump

President Trump’s illness from a coronavirus infection last month was the most significant health crisis for a sitting president in nearly 40 years. Yet little remains known about how the virus arrived at the White House and how it spread.

The administration did not take basic steps to track the outbreak, limiting contact tracing, keeping cases a secret and cutting out the Centers for Disease Control and Prevention. The origin of the infections, a spokesman said, was “unknowable.”

But one standard public health technique may still shed some light: tracking the cluster’s genetic fingerprints.

To better understand the outbreak, The Times worked with prominent geneticists to determine the genetic sequence of viruses that infected two Times journalists believed to been exposed to the coronavirus as part of their work covering the White House.

The study reveals, for the first time, the genetic sequence of the virus that may have infected President Trump and dozens of others, researchers said. That genome is a crucial clue that may allow researchers to identify where the outbreak originated and whether it went on to infect others across the country.

The White House has not disclosed any effort to conduct similar genetic testing, but the study’s results show that it is still possible, even weeks after positive tests. Additional sequencing could help establish the path of the virus through the White House, the role of a possible super-spreading event for Judge Amy Coney Barrett and the origin of an outbreak among the staff of Vice President Mike Pence in the last week or so.

The journalists, Michael D. Shear and Al Drago, both had significant, separate exposure to White House officials in late September, several days before they developed symptoms. They did not spend any time near each other in the weeks before their positive tests.

Mr. Shear traveled with Mr. Trump and other staff on Air Force One on Sept. 26, when Mr. Trump approached within five or six feet without a mask. Mr. Drago covered the Judge Barrett event that day and a news conference the next day near officials who were not wearing masks and later tested positive.

The viral genomes of the two journalists shared the same distinct pattern of mutations, the research found. Along with their exposure history, the findings suggest that they were infected as part of the broader White House outbreak, said Trevor Bedford, a geneticist at the Fred Hutchinson Cancer Research Center and the University of Washington who led the research team.

“These mutations that are possessed by these viruses are quite rare in the United States,” Dr. Bedford said. “I am highly convinced that these viruses come from the same outbreak or cluster based on their genomes.”

The study, which has been posted online but not yet peer reviewed or published in a science journal, followed academic protocols that require genetic samples to be anonymous. Mr. Shear and Mr. Drago chose to disclose their identities for this article.

Viruses constantly mutate, picking up tiny, accidental alterations

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Trump admin. funds plasma company based in owner’s condo

WASHINGTON (AP) — An obscure South Carolina company may be in line for millions of dollars in U.S. government funding to produce a coronavirus treatment after a former Republican senator with a financial stake in the business lobbied senior U.S. government officials.

Plasma Technologies LLC, has received seed money to test a possible COVID-19-fighting blood plasma technology. But as much as $65 million more could be on the way, a windfall for the company that operates out of the founder’s luxury condo, according to internal government records and other documents obtained by The Associated Press.

The story of how a tiny business, which exists only on paper, has managed to snare so much top-level attention is emblematic of the Trump administration’s frenetic response to the coronavirus pandemic.

And it’s another in a series of contracts awarded despite concerns over their proposals voiced by government scientists. The others include an $21 million study of the heartburn drug Pepcid as a COVID therapy, and more than a half-billion dollars to ApiJect Systems America, a startup with an unapproved medicine injection technology and no factory to manufacture the devices. In addition, a government whistleblower claimed that a $1.6 billion vaccine contract to Novavax Inc. was made over objections of scientific staff.

At the center of these deals is Dr. Robert Kadlec, a senior Trump appointee at the Department of the Health and Human Services, who backed the Pepcid, Novavax and ApiJect projects. Records obtained by the AP also describe Kadlec as a key supporter of Plasma Tech, owned by Eugene Zurlo, a former pharmaceutical industry executive and well-connected Republican donor. Three years ago, Zurlo brought Rick Santorum, who spent 12 years as a GOP senator from Pennsylvania, aboard as a part-owner.

Kadlec has come under pressure from the White House to act with more urgency and not be bound by lower-level science officials whom Trump has castigated as the “deep state” and accused of politically motivated delays in fielding COVID-19 vaccines and remedies.


The AP reached out to more than a dozen blood plasma industry leaders and medical experts. Few had heard of Zurlo’s company or its technology for turning human plasma into protein-rich antibody therapies, and would not comment.

Zurlo said in an email that the shortage of plasma from recovered COVID-19 patients, which is needed to make these therapies, underlines the need for the technology he’s patented to harvest as many of these proteins as possible.

In early April, shortly after Congress supplied hundreds of billions of dollars to combat the pandemic, Santorum stepped up his sales pitch for Plasma Technologies and the process the company has described as “disruptive and transformative,” according to the records.

In mid-August, the federal government awarded Plasma Technologies a $750,000 grant to demonstrate that it could deliver on its promises.

HHS would not comment when asked whether Santorum’s public backing of the president helped the company he has a financial stake in getting a government contract.

Santorum told the AP it would have been a

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