Afghanistan suspends officials after women’s soccer team abuse investigation

Afghanistan’s Attorney General has suspended the head of the Afghan Football Federation after a probe into allegations of sexual abuse of members of the national women’s soccer team, a spokesman for the attorney general said on Sunday.


Reuters: Sports News

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The Briefing Room: Celebrating H.W. Bush, US Markets and China tariffs, Mueller investigation

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Report: Cleveland PD Launching Internal Investigation Into How NFL Obtained Kareem Hunt Police Report

An unidentified officer reportedly leaked a copy of a police report following an incident involving Hunt in February.

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Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it agreed with the report recommendations regarding documentation and that the agency is “streamlining our processes.” The agency declined requests for interviews. In a comment included with the report, Matthew Bassett, assistant secretary for legislation at the Department of Health and Human Services, said HHS agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start as treatments for rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $ 147,308 in 2017 compared with $ 30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the United States. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $ 5.4 billion in sales and $ 184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $ 10 billion drugs, even though they are for rare diseases.”

From 2008 to 2017, more than half of the drugs granted orphan status were for cancer or blood disorders, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News

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Michael Cohen pleads guilty to misleading Congress about Russia investigation

Michael Cohen is in federal court in New York where he is expected to plead guilty to making false statements to Congress about the Russia investigation, CNN has learned.


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American scientist under investigation over ties to alleged genetic editing

This comes amid a scientific controversy.
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Elon Musk’s pot-smoking video prompts NASA investigation

NASA has launched a safety probe into SpaceX and Boeing, which are under $ 6.8 billion contracts to fly its astronauts to space, because Elon Musk sipped whiskey on the rocks and smoked pot — legally — on a podcast, according to a new report. Officials at the space agency will hold hundreds of “pretty invasive”…
Business | New York Post

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Russian Soyuz rocket failure caused by damaged sensor: investigation

The abortive launch last month of a manned Soyuz mission to space was caused by a sensor damaged during the rocket’s assembly at the cosmodrome in Kazakhstan, Russian investigators said on Thursday.


Reuters: Science News

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Stacey Abrams: Brian Kemp’s investigation is desperate

CNN

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Exclusive: Trump blamed ex-counsel McGahn for Mueller investigation

Former White House Counsel Don McGahn ended his tumultuous tenure at the White House with one last encounter in which President Donald Trump blamed him for Robert Mueller’s appointment, sources close to McGahn tell CNN.


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FBI Report on Kavanaugh Investigation, a Play About Hillary Clinton – Monologue

Late Night with Seth Meyers

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‘The Briefing Rom’: Migrant caravan, Texas senate race, Khashoggi investigation | ABC News

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Rod Rosenstein believes Mueller Russia investigation is ‘appropriate and independent’: WSJ

Deputy Attorney General Rod Rosenstein characterized the special counsel investigation into Russian interference in the 2016 elections as "appropriate and independent" in an interview with The Wall Street Journal.
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WATCH: World News 10/04/18: Firestorm As FBI Investigation On Kavanaugh Concludes

Rescue efforts for survivors continue after Indonesia earthquake and tsunami; US, UK, and Holland fighting back against Russia’s cyber attacks
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FBI interviews: Who spoke in the Kavanaugh investigation

With the FBI’s supplemental review of Supreme Court nominee Brett Kavanaugh completed, senators began filing in Thursday to learn of the agency’s findings.


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Democrats And Republicans Divided Over FBI’s Kavanaugh Background Investigation | NBC Nightly News

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Two key undecided senators say Kavanaugh FBI investigation ‘very thorough’

Two key Republican senators who have been undecided on whether to vote to confirm Brett Kavanaugh described the FBI’s findings of an investigation into President Donald Trump’s Supreme Court nominee as a thorough report, contrasting with Democrats’ objections that the inquiry was rushed and incomplete.


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‘The Debrief’: Kavanaugh investigation, Trump rallies Mississippi, MLB playoffs | ABC News

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Trump decries ‘trauma’ done to Kavanaugh, calls for ‘comprehensive’ investigation

President Donald Trump on Monday decried the “trauma” Supreme Court nominee Brett Kavanaugh has been subjected to in the confirmation process, but says he wants the FBI investigation to be “comprehensive” but “quick.”


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