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Who Owns H.I.V.-Prevention Drugs? The Taxpayers, U.S. Says

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After years of prodding by patient advocates, federal officials on Wednesday sued the drug maker Gilead Sciences, charging that it had infringed government patents on the idea of preventing H.I.V. with a daily pill.

The suit, by the Department of Health and Human Services, came as a pleasant shock to many critics of the company, including Democratic members of Congress who had pressed the administration to act.

It is very rare for the government to take on a drug maker over patents. But the medications made by Gilead are necessary to end the AIDS epidemic by 2030, which the Trump administration has set as a goal. That cannot be accomplished if the drugs are not made more affordable.

Still, exactly what effect the lawsuit will have on the war on AIDS remains unclear.

Certainly, it was an unexpected turnabout by Alex M. Azar II, the secretary of health and human services. In May, he had praised Gilead for donating Truvada to the administration’s campaign to beat the AIDS epidemic.

On Wednesday, Mr. Azar struck a much harsher tone. “Gilead must respect the U.S. patent system, the groundbreaking work by C.D.C. researchers, and the substantial taxpayer contributions to the development of these drugs,” he said in a prepared statement.

The lawsuit bluntly accused Gilead of exaggerating its role in developing pre-exposure prophylaxis, or PrEP, ignoring work by government scientists and “baselessly denying” the validity of federal patents.

The Department of Health and Human Services declined to explain on Thursday what led Mr. Azar to change his tone and request a jury trial.

“The fact that the federal government sued a drug maker over a medication developed in part with taxpayer money is a milestone,” said Zain Rizvi, a researcher in the medicines access program at the advocacy organization Public Citizen.

“We hope it marks a fundamental shift in how the government will think about the many other medicines developed using public funding that remain unaffordable for millions of Americans,” Mr. Rizvi said.

Gilead has responded that the government patents are invalid and denied infringing them.

The government first applied for patents on prophylaxis techniques in 2006. Gilead recently asked the Patent and Trademark Office to cancel the government patents, arguing that other researchers already had conceived the idea of using drugs to prevent H.I.V.

Gilead said it would ask the court to stay the government’s suit until the patent office reaches a decision.

PrEP is a drug regimen: A person at risk of contracting H.I.V. is prescribed one of two drugs to be taken in pill form once daily to prevent the infection. Both of the drugs approved for use in this regimen, Truvada and Descovy, are made by Gilead.

If taken daily, the drugs cut the risk of H.I.V. infection by more than 99 percent. Public health officials are eager to get more people on PrEP, and the Trump administration in February announced an enormous effort to get the drugs to people in high-risk communities.

About one million Americans are at high risk of getting H.I.V. through sex or shared needles and would benefit from PrEP, according to the Centers for Disease Control and Prevention. But just 270,000 Americans are on PrEP, and there are about 40,000 new infections each year.

The price has been an obstacle, critics say. Truvada, which will come off patent next year, has cost about $20,000 per patient per year in recent years; Descovy currently costs about the same. In other countries, generic versions of Truvada sell for as little as $60 a year.

Gilead has said that virtually no patient pays the list price, and that those who cannot afford the drug may qualify for assistance.

“In 15 years, PrEP has never ceased to surprise me,” said Mitchell J. Warren, executive director of AVAC, an H.I.V.-prevention advocacy group based in New York. “This was an action I did not expect to see, especially after the announcement about Gilead’s donation.”

In May, Gilead and H.H.S. jointly announced that the company would donate enough Truvada to cover 200,000 patients for up to 11 years. The recipients were to be switched to a more expensive replacement, Descovy, once it was approved for prevention of H.I.V. infection.

The Food and Drug Administration approved Descovy for PrEP last month.

Although Mr. Azar praised Gilead for its donation, H.I.V. activists and some medical experts greeted the arrangement with suspicion, saying that it appeared to be an effort to build a market for Descovy.

Gilead has made about $3 billion a year on Truvada and would presumably make at least that much on Descovy, if insurers and government programs switch patients to the new drug instead of adopting generic equivalents to Truvada.

Descovy contains tenofovir alafenamide, a precursor molecule to tenofovir disoproxil, the main drug in Truvada. Gilead claims Descovy is less likely than Truvada to cause kidney damage or bone loss.

Critics note that Truvada is safe, and that Gilead has said so for years. They also point to a study suggesting that Descovy raises cholesterol levels more than Truvada does.

In September, four months after news of Gilead’s donation, H.H.S. announced that it would award the drug maker a $6 million contract to distribute donated Truvada and Descovy. The six-month contract, with a renewal option, paid Gilead to distribute the drugs to about 4,000 needy people.

But most drug makers already have programs like this one — including Gilead, which since 2012 has run a medication assistance program through which the company has provided Truvada free of charge to about 20,000 people each year.

Activists for H.I.V. patients said 4,000 more recipients amounted to a drop in the bucket, compared with the overall need. And they wondered why the government should pay for a separate distribution program when Gilead already has one.

“I’m very confused about who except Gilead is benefiting from this arrangement,” said Jeremiah Johnson, a project director at Treatment Action Group, an H.I.V. advocacy organization.

Individuals with drug addictions or mental problems, or who are homeless or live in distant rural areas, are very difficult and expensive for public health departments to enroll and keep on PrEP.

But there was no indication in the Gilead contract that such intensive services would be provided. The drug maker’s current assistance program simply provides Truvada free to anyone who comes to a pharmacy with a prescription, lacks health insurance and earns less than $62,450 a year.

The basis of the government’s patent claim is that, in the early 2000s, scientists at the C.D.C. did many experiments on monkeys to see if antiretroviral drugs given subcutaneously, in vaginal or anal gels, or as oral pills, would protect them against infection with the simian version of H.I.V.

Tenofovir was invented in Czechoslovakia in 1985, and Gilead later purchased the American patent rights.

Patents normally last for 20 years, but drug companies often do everything they can to “evergreen” them and head off generic competition by making small changes in the molecules, the combinations made with them, or the way they are delivered.

Gilead first released Truvada for H.I.V. treatment in 2004, charging less than $10,000 a year.

After it was approved for prevention in 2012, however, Gilead slowly raised the price to about $20,000.

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The company also sued every generic maker that tried to enter the market, and then reached out-of-court settlements with each one. The details were kept secret, but activists believe that Gilead paid each company millions of dollars to stay out of the market — “pay-for-delay” deals.

In June, Senator Debbie Stabenow, Democrat of Michigan, and the late Representative Elijah Cummings, Democrat of Maryland, asked the Government Accountability Office to open an investigation into why H.H.S. had not enforced its patents against Gilead.

“After shining a light on Gilead’s unfair practices, I am pleased to see H.H.S. decide to take action against Gilead,” Ms. Stabenow said Thursday.

“Drug companies should not be able to charge patients tens of thousands of dollars for lifesaving treatments, discovered through taxpayer-funded research, nor should they be allowed to infringe on government-owned intellectual property with impunity.”



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Live impeachment hearing updates: Fiona Hill, David Holmes testimony

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Fiona HillFiona Hill was the top adviser on Russia in the White House until she left the administration over the summer.AP Photo/Andrew Harnik

  • House investigators leading the impeachment inquiry into President Donald Trump are scheduled to hear from Fiona Hill and David Holmes on Thursday.
  • Hill, the former top Russia adviser on the National Security Council, in closed-door testimony already offered a scathing picture of shadowy efforts to urge Ukraine to investigate Trump’s political rivals.
  • Holmes is a top staffer at the US Embassy in Ukraine and worked closely with Marie Yovanovitch while she was serving as the US ambassador to Ukraine. He overheard a phone call with Trump relevant to the inquiry.
  • They’re scheduled to testify at 9 a.m. ET.
  • Visit Business Insider’s homepage for more stories.

Fiona Hill, the former director for Europe and Russia on the National Security Council, and David Holmes, a top staffer at the US Embassy in Ukraine, are set to testify before House investigators Thursday for the public impeachment hearings into President Donald Trump.

The hearing will be broadcast on C-SPAN and the major cable news networks. Insider will also embed a livestream of the hearings here when they kick off.

Watch the hearing here:

 


LIVE: Fiona Hill and David Holmes to testify in Thursday’s impeachment hearing

House investigators leading the impeachment…

LIVE: Fiona Hill and David Holmes to testify in Thursday’s impeachment hearing

Fiona Hill,Impeachment inquiry,Trump impeachment,Ukraine,Russia,John Bolton,Donald Trump,Impeachment,Joe Biden,David Holmes,Features

LIVE: Fiona Hill and David Holmes to testify in Thursday’s impeachment hearing

2019-11-21T15:00:00+01:00

2019-11-20T17:41:42+01:00

2019-11-21T15:05:27+01:00

https://headsn.com/wp-content/uploads/2019/11/1574362554_919_Live-impeachment-hearing-updates-Fiona-Hill-David-Holmes-testimony.jpg

BusinessInsiderDe



House investigators leading the impeachment inquiry into President Donald Trump are scheduled to hear from Fiona Hill and David Holmes on Thursday.
Hill, the former top Russia adviser on the National Security Council, in closed-door testimony already offered a scathing picture of shadowy efforts to urge Ukraine to investigate Trump’s political rivals.
Holmes is a top staffer at the US Embassy in Ukraine and worked closely with Marie Yovanovitch while she was serving as the US ambassador to Ukraine. He overheard a phone call with Trump relevant to the inquiry.
They’re scheduled to testify at 9 a.m. ET.
Visit Business Insider’s homepage for more stories.

Fiona Hill, the former director for Europe and Russia on the National Security Council, and David Holmes, a top staffer at the US Embassy in Ukraine, are set to testify before House investigators Thursday for the public impeachment hearings into President Donald Trump.
The hearing will be broadcast on C-SPAN and the major cable news networks. Insider will also embed a livestream of the hearings here when they kick off.
Watch the hearing here:
Youtube Embed: //www.youtube.com/embed/MpTIb_HubrY Width: 560px Height: 315px
 

Read more of Insider’s impeachment coverage:
Think Trump will get impeached? Gambling sites say the odds are in your favor
Trump could be impeached and removed from office but still win reelection in 2020
Over half of the House members support the impeachment inquiry against Trump — see all of them here
Everything you need to know about Trump’s impeachment process: What’s happened, who the players are, and what comes next

international

LIVE: Fiona Hill and David Holmes to testify in Thursday’s impeachment hearing

House investigators leading the impeachment…

LIVE: Fiona Hill and David Holmes to testify in Thursday’s impeachment hearing

Fiona Hill,Impeachment inquiry,Trump impeachment,Ukraine,Russia,John Bolton,Donald Trump,Impeachment,Joe Biden,David Holmes,Features

LIVE: Fiona Hill and David Holmes to testify in Thursday’s impeachment hearing

2019-11-21T15:00:00+01:00

2019-11-21T15:05:27+01:00

https://headsn.com/wp-content/uploads/2019/11/1574362554_919_Live-impeachment-hearing-updates-Fiona-Hill-David-Holmes-testimony.jpg

BusinessInsiderDe



House investigators leading the impeachment inquiry into President Donald Trump are scheduled to hear from Fiona Hill and David Holmes on Thursday.
Hill, the former top Russia adviser on the National Security Council, in closed-door testimony already offered a scathing picture of shadowy efforts to urge Ukraine to investigate Trump’s political rivals.
Holmes is a top staffer at the US Embassy in Ukraine and worked closely with Marie Yovanovitch while she was serving as the US ambassador to Ukraine. He overheard a phone call with Trump relevant to the inquiry.
They’re scheduled to testify at 9 a.m. ET.
Visit Business Insider’s homepage for more stories.

Fiona Hill, the former director for Europe and Russia on the National Security Council, and David Holmes, a top staffer at the US Embassy in Ukraine, are set to testify before House investigators Thursday for the public impeachment hearings into President Donald Trump.
The hearing will be broadcast on C-SPAN and the major cable news networks. Insider will also embed a livestream of the hearings here when they kick off.
Watch the hearing here:
Youtube Embed: //www.youtube.com/embed/MpTIb_HubrY Width: 560px Height: 315px
 

Read more of Insider’s impeachment coverage:
Think Trump will get impeached? Gambling sites say the odds are in your favor
Trump could be impeached and removed from office but still win reelection in 2020
Over half of the House members support the impeachment inquiry against Trump — see all of them here
Everything you need to know about Trump’s impeachment process: What’s happened, who the players are, and what comes next

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Over 200 economists, academicians ask government to release NSSO data, reports

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More than 200 economists and academicians have asked the government to release data of all surveys and reports, including results of the Consumer Expenditure Survey 2017-18, completed by the National Sample Survey Office (NSSO). According to some media reports, the 2017-18 Consumer Expenditure Survey shows a sharp decline in average consumption and the survey results are not being released because they support other evidence that the economy is experiencing a downturn, they said in a statement.

“It should be noted that consumption surveys are known to give results that diverge from macroeconomic estimates of the National Accounts,” they said.

Also, National Accounts estimates are based not only on administrative data but on a combination of sources including NSSO and other surveys. Several committees have looked into these discrepancies.

“In the interest of transparency and accountability, all data must be released without delay and irrespective of what the results are.

“The government may wish to defend itself against interpretations of the statistics that it disagrees with,” the statement said.

But this is best-done through technical papers and seminars. To prevent release of data that are adverse, and diverge from its own understanding, is “neither transparent nor technically sound”, it said.

“We therefore demand that the government should immediately release the report and unit-level data of the 75th Consumer Expenditure Survey. The government should also commit to release all other survey data after the usual processes to check for possible errors have been concluded,” they said.

The economists and academicians who issued the statement, include A Vaidyanathan and Abhijit Sen (former members of erstwhile Planning Commission), Biswajit Dhar (JNU), Dilip Mookherjee (Boston University), Maitreesh Ghatak (LSE), Prabhat Patnaik (Emeritus Professor, JNU), and Thomas Piketty (Paris School of Economics).





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Liberty’s Malone says Softbank’s Son ‘flings’ numbers around

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Liberty Media’s John Malone

Michael Kovac | Getty Images

Liberty Media Chairman John Malone took issue with SoftBank CEO Masayoshi Son’s investment approach in light of the botched WeWork IPO.

“He flings these numbers around awful easy. He’s got a balance sheet no one can understand,” Malone told CNBC’s David Faber in an exclusive interview Thursday.

WeWork pulled its IPO filing in September after investors balked at its mounting losses and unusual corporate governance structure. The scrutiny forced WeWork founder Adam Neumann to step down as CEO. The office-sharing start-up is laying off 2,400 employees as it tries to cut costs and right-size the business.

Son initially valued WeWork at $47 billion, a number public market investors viewed as nearly four times too high.

“I look at each one of these deep-loss businesses … you’ve got to have to have an argument that the scale will improve the marginal economics,” Malone said.

WeWork continues to bleed cash, reporting $1.25 billion in losses in the third quarter, up more than 150% from the same period last year. The company was poised to run out of money in a matter of weeks, but secured an 11th-hour bailout deal from SoftBank.

“[Masa’s] had some home-runs no question. He took some big rides and some of them are not performing for him at the moment, but those are cycles,” Malone said.

Malone is also not a fan of Uber’s business model.

“I never quite understood Uber and I never quite understood why Dara took the job,” Malone said of Dara Khosrowshahi, who succeeded CEO Travis Kalanick in 2017 following a series of scandals. “Right now in a world where you have three or four competitors in a metro area and drivers are working for all of them, I don’t see where scale changes the economics.”

Uber shares have fallen about 35% since its IPO in May.



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