October 27, 2017
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Dr. John N. Kapoor, the billionaire founder of Insys Therapeutics, was arrested and charged Thursday with bribing doctors to prescribe Subsys, a spray meant for cancer patients that contains the highly addictive synthetic opioid fentanyl.

Kapoor, 74, was arrested in Phoenix, and is facing federal charges of racketeering, conspiracy to commit fraud, and conspiracy to violate an anti-kickback law; the racketeering and fraud charges alone carry possible prison sentences of up to 20 years. Subsys was approved by the FDA to treat cancer patients who have pain that can't be helped by any other narcotics, and a 30-day supply costs between $3,000 and $30,000, NBC News reports; in the last year, Insys has sold $240 million worth of Subsys. Prosecutors allege Insys paid doctors hundreds of thousands of dollars in exchange for them prescribing Subsys, which is 100 times stronger than morphine.

Three of the top prescribers have been convicted of accepting bribes from Insys, and Insys denies any wrongdoing, saying the company cannot be held responsible for how doctors prescribe products. Over the summer, former employee and whistleblower Patty Nixon told NBC News she was trained to make sure doctors prescribed Subsys, even to patients who did not have cancer. She contacted insurance companies on behalf of the patients and doctors, she said, sometimes pretending to work for a doctor who treated cancer patients to make it easier for her requests to go through. Catherine Garcia

October 26, 2017

President Trump made rare mention of his late older brother Fred on Thursday while declaring the opioid crisis to be a national public health emergency.

Fred Trump Jr. suffered from alcoholism and died in 1981 at the age of 43. The president, who is famously a teetotaler, credited his older brother for steering him away from alcohol. "[Fred] had a problem with alcohol, and he would tell me, 'Don't drink,'" Trump said.

Trump went on to say that he has watched his friends struggle with alcohol over the years and that "the fact is, if we can teach young people and people generally not to start [taking drugs], it's really, really easy not to take them." He emphasized the importance of a "really tough, really big, really great advertising" campaign to raise awareness and added: "There is nothing desirable about drugs. They're bad."

The president also said that the government would require a particular "truly evil" opioid to be removed from the market, as well as promote research for non-addictive pain management techniques. Trump had been heavily criticized for not triggering a federal response to the crisis sooner, after saying he would make an announcement back in early August.

STAT estimated earlier this year that opioids could kill nearly 500,000 Americans in the next decade. Watch Trump's remarks about Fred below. Jeva Lange

October 26, 2017
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On Wednesday night, President Trump told reporters that he is "going to have a big meeting on opioids" Thursday, and White House officials tell USA Today that Trump will order the Health and Human Services department to declare the opioid crisis a public health emergency, a step short of the national emergency he promised to declare in August and again last week — to the surprise and consternation of his staff. Trump said the order would give the federal government the "power to do things that you can't do right now," and White House officials said the renewable 90-day order would give states more flexibility to spend the $1 billion for opioid treatment Congress approved last year as part of the 21st Century Cures Act, plus tap other funds.

States have already received half of their Cures Act funding, but it is taking time to reach addicts. Some of the lag involves setting up new programs and training, but federal rules on controlled substances have also gotten in the way. The public health emergency declaration should clear some of those, like prohibitions on prescribing opioid addiction treatments over the phone.

Trump's opioid commission, headed by New Jersey Gov. Chris Christie, had recommended a more robust national emergency declaration, which draws on a different law and would have presented Trump with the authority to waive privacy laws and Medicare regulation. The public health emergency declaration allows states to tap the HHS's Public Health Emergency Fund, which currently holds $57,000. "My view is that this action sends a clear signal from the president that he wants money appropriated into that fund," Christie told USA Today. "And it gives Congress a place to go with that money to give the administration some flexibility to use it." Trump won't request any funds in his executive order. Peter Weber

October 20, 2017
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President Trump assured critics that he would officially declare the opioid crisis to be a national emergency next week, which was apparently news to his own officials. "They are not ready for this," one public health advocate told Politico after discussing Trump's promise with Health and Human Services officials. A senior Food and Drug Administration official agreed, calling it "such a mess."

Opioids are the leading cause of unintentional death in the United States. STAT estimated earlier this year that opioids could kill nearly 500,000 Americans in the next decade. But "Trump's off-script statement stunned top agency officials, who said there is no consensus on how to implement an emergency declaration for the drug epidemic," Politico writes.

Part of the disagreement boils down to how to declare the emergency: The Stafford Act, which is normally used for natural disasters like hurricanes or earthquakes, could open up federal dollars for the opioid crisis but might not be legally sound. Trump could instead declare a more narrowly focused public health emergency, but that would rely on the mere $57,000 in available money from HHS. Trump could also look to Congress, but that approach still hasn't been finalized.

“The reaction [to Trump's promise] was universal," one senior health official told Politico. "Believe it when [we] see it." Read more about why if the opioid crisis isn't a national emergency, nothing is, at The Week. Jeva Lange

October 17, 2017

On Sunday night, 60 Minutes and The Washington Post reported that Rep. Tom Marino (R-Pa.) had worked for two years to push through a bill promoted and apparently written by the pharmaceutical industry that stripped the Drug Enforcement Administration of its biggest tool to fight prescription opioids entering the black market. Marino is President Trump's nominee to head the Office of National Drug Control Policy. On Monday, Trump called Marino "a good man," a "great guy," and "a very early supporter of mine — the great state of Pennsylvania," but said that after Sunday's 60 Minutes, "we're going to look into the report. We're going to take it very seriously."

Trump did not say if he would withdraw Marino's name to be drug czar, but hinted that he might. "I have not spoken to him, but I will speak to him, and I'll make that determination," he told reporters in the Rose Garden. "And if I think it's 1 percent negative to doing what we want to do, I will make a change, yes."

Democrats and a few Republicans backed repealing the law — which passed on voice votes with no objections — and some Democrats urged Trump to dump Marino. Sen. Richard Blumenthal (D-Conn.) said the drug czar "is supposed to be a watchdog, not a lap dog," and warned that if Trump pursues the nomination, "it will be ugly."

Trump also said he plans to declare the opioid crisis a national emergency next week, calling the epidemic a "massive problem" he wants to get "absolutely right." Democrats and a few Republicans said they were stunned by the report, insisting they had been assured by DEA officials that the bill would not hamper the fight against opioid addiction. You can learn more about the reaction in Washington in the CBS News report below. Peter Weber

October 16, 2017

Last year, Congress passed a law pushed by the pharmaceutical industry that stripped the Drug Enforcement Administration (DEA) of its most potent tool to fight illicit distribution of prescription opioid pain medications to shady clinics and unscrupulous doctors, The Washington Post and CBS's 60 Minutes reported Sunday night. The main sponsors and advocates of the bill were Rep. Tom Marino (R-Pa.) and Rep. Marsha Blackburn (R-Tenn.), whose districts are both hard-hit by the opioid epidemic. Blackburn is running for Senate, for the seat being vacated by Sen. Bob Corker (R), and Marino is President Trump's pick to be America's drug czar. Former President Barack Obama signed the law in April 2016.

60 Minutes dedicated half an hour to the story, interviewing former DEA officials, investigators, and lawyers, but mostly Joe Rannazzisi, who led the division in charge of regulation and investigation of the pharmaceutical industry and, according to CBS News, "one of the most important whistleblowers ever interviewed by 60 Minutes." He was sidelined and retired after a concerted push by Marino and, he and others suggested, drug lobbyists.

Rannazzisi told 60 Minutes that as opioid-overdose deaths continued to rise sharply, his division turned from prosecuting just pain clinics, pharmacists, and doctors who were illegally selling opioids to targeting the distributors that "allowed millions and millions of drugs to go into bad pharmacies and doctors' offices, that distributed them out to people who had no legitimate need for those drugs." He named names. His interpretation of Marino's bill is shared by Chief DEA Administrative Law Judge John J. Mulrooney II.

You can learn more about the increasing internal and external pressure on Rannazzisi and his team, the revolving door — the Marino bill was apparently written by Linden Barber, a top DEA lawyer-turned-lobbyist — and the role of distributors in the opioid food chain at 60 Minutes. Trump has still not declared the opioid epidemic a national crisis, despite saying he would in August. Peter Weber

October 12, 2017

Democratic Sen. Elizabeth Warren (Mass.) and Republican Sen. Lisa Murkowski (Alaska) have co-authored a letter to President Trump asking where his opioid epidemic declaration is. It has been 63 days since Trump promised he would declare a crisis, but he has not done so yet.

"On Aug. 10, 2017, you declared that '[t]he opioid crisis is an emergency and I'm officially saying right now it is an emergency — we're going to draw it up and we're doing to make it a national emergency. It is a serious problem of the likes of which we've never had,'" wrote Warren and Murkowski. But while the senators "applaud" Trump for addressing addiction, "we are extremely concerned that 63 days after your statement, you have yet to take the necessary steps to declare a national emergency on opioids, nor have you made any proposals to significantly increase funding to combat the epidemic."

An estimated 900,000 Americans overdosed in 2015, with over 30,000 of those overdoses fatal and stemming from opioid drugs. Opioids are the leading cause of unintentional death in the United States. STAT estimated earlier this year that opioids could kill nearly 500,000 Americans in the next decade.

"This kind of delay between pronouncement and formal declaration is not normal," The New York Times writes. "In the past, formal declarations and public pronouncements of a public emergency generally have happened simultaneously." Read more about what it means to declare a public emergency at The New York Times, and read Murkowski and Warren's full letter here. Jeva Lange

September 22, 2017

CVS Pharmacy announced Friday that it will be limiting opioid prescriptions to seven days for certain patients, including those who are new to prescription pain medications, CNN reports. The pharmacy's decision comes as opioid prescriptions have quadrupled since 1999 despite the fact that there has been no significant rise in conditions calling for such medications among American patients.

An estimated 900,000 Americans overdosed in 2015, with over 30,000 of those overdoses fatal and stemming from opioid drugs. Opioids are the leading cause of unintentional death in the United States. STAT estimated earlier this year that opioids could kill nearly 500,000 Americans in the next decade.

CVS pharmacists also plan to teach patients about the risk of addiction that comes with the pain medications, and insist on the importance of keeping the drugs somewhere secure. "With a presence in nearly 10,000 communities across the country, we see firsthand the impact of the alarming and rapidly growing epidemic of opioid addiction and misuse," said CVS Health's president and CEO, Larry J. Merlo.

The pharmacy will roll out the changes beginning Feb. 1, 2018. Jeva Lange

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