The Food and Drug Administration (FDA) can’t prove that a program intended to curb opioid misuse and improper prescribing was ever effective, according to an analysis of newly uncovered documents.

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The analysis, published Monday in the journal JAMA Internal Medicine, found that the FDA never collected the right data to determine the effectiveness of the program in reducing addiction or changing physician prescribing practices. 

The authors from the Johns Hopkins Bloomberg School of Public Health reviewed more than 9,700 pages of FDA documents gained by Freedom of Information Act requests related to the agency’s risk evaluation and mitigation strategy (REMS).

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The strategy was launched in 2012 to address risks tied to extended-release and long-acting opioids, which were more associated with greater risk of addiction, unintentional overdose and death than their immediate-release counterparts.

The REMS program was intended to be the FDA’s primary tool “to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse,” according to the researchers. 

Yet the authors found that “more than 5 years after implementation, the FDA was unable to assess whether these outcomes were achieved.”

Under the program, the FDA required opioid manufacturers to pay for voluntary safety training for physicians who prescribe the drugs, and to track the effectiveness of the training. 

The researchers found the REMS program was implemented “largely as planned,” but when its shortcomings became known, “FDA instead changed the goal” of the assessments, instead of improving them. 

The agency could have done more to study the program’s effectiveness, and has come under fire for allowing drug companies to fund prescriber training. Prior assessments of the REMS program have also been funded by opioid manufacturers, and a May 2016 FDA advisory committee noted “methodological concerns” regarding the studies.

In an editorial accompanying the analysis, retired senior FDA official William Hubbard called on the FDA to take more aggressive action, and said the agency has “broad authority” to restrict the distribution of dangerous medications.

FDA “has tools that could mitigate opioid risks more effectively if the agency would be more assertive in using its power to control opioid prescribing, manufacturing, and distribution,” Hubbard said.

In 2019, the swirl of scrutiny and souring public opinion around Big Tech coalesced into serious regulatory threats as every relevant government body in the country launched investigations into the largest and most significant technology companies in the world. 

Lawmakers pointed fingers at tech companies like Facebook, Google’s YouTube and Twitter as they worked to assign blame in the aftermath of horrific mass shootings and acts of terror, which went viral online. And they lambasted the social media companies for allowing lies and smears about politicians to spill unabated across their platforms. 

The upcoming year is almost certain to bring an intensified level of antagonism and friction between the top tech companies and the U.S. government, with a stronger threat of regulatory action than ever before.

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Here are the top tech policy stories to watch for in 2020. 

 

Antitrust investigations

In 2020, the word “antitrust” will become near-synonymous with “Big Tech.” 

During the second half of 2019, the Department of Justice (DOJ), Federal Trade Commission (FTC), nearly every state attorney general and a key House Committee all announced separate antitrust probes into the unparalleled power and dominance of the top tech companies. The level of scrutiny signals the government intends to rein in those companies, but it is unclear when or how.

Only the House Judiciary Committee’s investigation into Facebook, Google, Amazon and Apple is certain to wrap up during 2020. The man leading the probe, House Judiciary antitrust subcommittee chairman Rep. David CicillineDavid Nicola CicillineFive things to watch in tech for 2020 Democratic senators tweet photos of pile of House-passed bills ‘dead on Mitch McConnell’s desk’ Impeachment obliterates tinges of comity in House MORE (D-R.I.), is vowing to put out a report about their findings in the “early part of 2020.”

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Then, Cicilline says, he will unveil legislation designed to update centuries-old antitrust laws for the digital age.

“We want to introduce legislation with sufficient time to actually act on it,” Cicilline told The Hill. 

“I think it will be the year that we have some very strong proposals to respond to the absence of competition in the digital marketplace, and to demonstrate that these big technology companies can’t be trusted to regulate themselves,” Cicilline said. “It requires the active participation of Congress.” 

It’s yet to be seen how much support he will get in the Senate, but Sen. Elizabeth WarrenElizabeth Ann WarrenYang raises .5 million in final week of December Sanders: Speed of Medicare for All plan is a ‘major difference’ with Warren Warren vows to ‘attack corruption in Washington’ in New Year’s Eve address MORE (D-Mass.), who has called for breaking up the big tech companies on the campaign trail, is a likely ally. 

Meanwhile, the separate but overlapping coalitions of state attorneys general, encompassing nearly every state in the U.S. besides California, will forge ahead in their investigations of Google and Facebook. Those battles are likely to spill into the courts as the companies fight tooth and nail against extensive document requests.  

Antitrust experts said it’s unlikely that the DOJ and FTC will wrap up their probes this upcoming year, pointing out that investigations of this scale often take years. 

 

TikTok 

TikTok, a buzzy social media app built around short-form videos set to music, found itself at the center of an unprecedented political firestorm when it burst into Western markets in 2019. It was the first time a Chinese-owned social media app made significant inroads in the U.S.

But the company is in a tenuous position as anti-Chinese sentiment reaches a fever pitch in Congress, the technological race between the U.S. and China intensifies, and the two economic superpowers wrangle over a potential trade deal. 

Top lawmakers also jumped into the fray, deeming TikTok a national security threat over its ties to China and its unfettered access to personal information on its millions of U.S. users, many of whom are young children.

TikTok is owned by ByteDance, a $75 billion Chinese media conglomerate, which must deal with a Chinese law requiring companies to provide assistance to Beijing.

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Sen. Josh HawleyJoshua (Josh) David HawleyThe most expensive congressional races of the last decade Senate GOP wants speedy Trump acquittal Hillicon Valley: Election security funding gets mixed response | Facebook tests community fact checking | Lawmakers look to block Chinese pick for IP organization | Secret court judge rebukes FBI over surveillance warrants MORE (R-Mo.), an outspoken tech critic who has waged a one-man battle against TikTok in the Senate, said “more and more people” are understanding the “significant” threats posed by the Chinese-owned app with 500 million monthly active users.

So far, there’s little evidence that TikTok has shared any data on U.S. users with the Chinese government. But industry watchers say the scrutiny of TikTok’s ties to Beijing is only going to become more serious as a little-known U.S. government entity, the Committee on Foreign Investment in the United States, continues to investigate the national security implications of ByteDance’s acquisition of TikTok.

In response, the company will likely work overtime to distance itself from China and lay down roots in the U.S., building out its team of American advisors and lobbyists to underline the daylight between itself and the Chinese Communist Party.

Expect Monument Advocacy, Bytedance’s high-profile Washington lobbyists, to appear more frequently in the halls of Congress as they work to beat back accusations of Chinese surveillance and censorship. 

“In 2020, we plan to continue building out our senior US leadership team, which we began at the start of 2019, and accelerated throughout the year,” a TikTok spokesperson told The Hill. 

But there’s likely little the company can do to appease lawmakers, most prominently Senate Minority Leader Chuck SchumerCharles (Chuck) Ellis SchumerSchumer renews call for witnesses to testify in impeachment trial in wake of ‘game changer’ report Giuliani associate to turn over iPhone data, documents to House committee Hanukkah attack highlights disturbing rise of anti-Semitic violence MORE (D-N.Y.), who has been beating the anti-TikTok drum with the support of Republican China hawks in the Senate. Schumer has raised concerns about multiple apps with connections to foreign countries. 

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A Schumer spokesman told The Hill that the Democratic Senate leader has “been raising concerns, and will continue to raise these concerns, with foreign owned apps that could pose a threat to US national security and Americans’ privacy.” 

 

Google v. Oracle

In 2020, the “copyright case of the decade” will reach the Supreme Court, setting the stage for a finale in the long-running saga of Google vs. Oracle, a legal battle that could fundamentally change how tech companies build their products.

After nearly a decade of dramatic arguments in lower courts, the Supreme Court has agreed to decide whether Google violated federal copyright law when it used some of Oracle’s programming language to build its Android operating system. 

Google says the software industry should remain open and allow engineers to build freely on one another’s platforms and use one another’s systems. But Oracle is accusing the search giant of stealing lines of its code, claiming almost $9 billion in damages. At issue is an unresolved question: whether it’s possible for a company to copyright an application programming interface (API), a vital tool that enables applications to communicate with one another. 

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Silicon Valley has watched the case closely since Oracle first sued Google in the Northern District of California in 2010. But now the contentious copyright battle is coming to Washington, D.C., leaving the future of the software industry in the hands of several wild-card justices who don’t have much history in digital copyright law.

“We welcome the Supreme Court’s decision to review the case and we hope that the Court reaffirms the importance of software interoperability in American competitiveness,” Jose Castaneda, a Google spokesperson, said. “Developers should be able to create applications across platforms and not be locked into one company’s software.”

Google’s brief is due by the beginning of January while Oracle’s is due by February, teeing up a Supreme Court hearing by the end of March and a ruling by about mid-2020 or later.

 

California’s privacy law

Congress has been struggling to work up even a draft of the nation’s first comprehensive privacy law, legislation that would draw sorely-needed guardrails around how companies are allowed to collect and use the personal information they’ve amassed on hundreds of millions of U.S. users. 

Top lawmakers have pledged they will have a wide-reaching privacy law passed and signed by the end of 2020. But they’ve blown past a slew of deadlines already since beginning bipartisan negotiations at the start of 2019. Even a key senator at the center of the privacy talks cast doubt on whether 2020 will be the “year of the privacy bill.”

“I have faith in the ability to get a strong privacy bill with willing partners,” Senate Commerce Committee ranking member Maria CantwellMaria Elaine CantwellHillicon Valley: House panel unveils draft of privacy bill | Senate committee approves bill to sanction Russia | Dems ask HUD to review use of facial recognition | Uber settles sexual harassment charges for .4M Key House committee offers online privacy bill draft Administration’s roadless rule exemption for Tongass National Forest is a special interest boondoggle MORE (D-Wash.) told reporters, days before Congress left for the holiday recess. “I don’t know if the United States Senate has the will to dedicate floor time to any major policy. We haven’t demonstrated that thus far and that’s what that would take too.”

“Is that going to happen in 2020?” Cantwell, who would have to sign off on any bipartisan compromise bill, asked. “I don’t know about that.” 

The looming impeachment trial and a distracting presidential election will likely leave privacy legislation at the bottom of most senators’ priority lists. 

In the absence of that federal law, California’s tough privacy law – which is set to go into effect on January 1 – will likely become the “de facto” U.S. standard as companies rejigger their systems to comply with the complicated and divisive statute across the country. The California law will become enforceable halfway through the year.

Some tech companies will likely sue California over the law, arguing that it is overly onerous and potentially harmful to smaller businesses that don’t have the resources to comply with complicated privacy regulations. But stakeholders agree: it’s coming, whether companies like it or not, and they could rack up significant legal fees if they don’t comply. 

Sen. Richard Blumenthal (D-Conn.), who is expected to put out bipartisan legislation with Sen. Jerry MoranGerald (Jerry) MoranFive things to watch in tech for 2020 The Hill’s Morning Report — Sponsored by AdvaMed — House panel delays impeachment vote until Friday McConnell, Grassley at odds over Trump-backed drug bill MORE (R-Kan.), said the California law going into effect just ups the stakes for Congress to take action.

“I think especially after California, the tech companies are going to want some uniformity and it should be sooner rather than later,” Blumenthal said. “I’m very hopeful that we will meet this historic test of protecting privacy, which is a real imperative and a growing demand to consumers.” 

 

Political misinformation 

As the country barrels into a presidential election year, the internet ecosystem is still dangerously vulnerable to political misinformation and viral “fake news,” several years after the U.S. discovered that its social media platforms were successfully manipulated by an army of Russian trolls seeking to sway the election in favor of President Donald TrumpDonald John TrumpGiuliani says he would be willing to testify in impeachment trial Trump expected to announce limited vaping ban this week Linda Ronstadt: Trump is ‘like Hitler, and the Mexicans are the new Jews’ MORE. 

Disinformation experts say many of the top social media platforms are rife with shady links, misleading memes and political conspiracy theories – and it’s only set to get worse amid a contentious election with over a dozen Democratic candidates and a president who has sowed discord online. 

Deputy director of the New York University Stern Center for Business and Human Rights Paul Barrett said voters should be “on the alert” for disinformation stemming from foreign actors – but “more likely, almost to the point of certainty, from domestic actors” seeking to “confuse people and prop up one candidate… and so forth.” 

As recently as this month, a fake story about Speaker Nancy PelosiNancy PelosiSenate Republican predicts impeachment trial ends by State of the Union Trump threatens Iran over embassy incident, which he calls the ‘Anti-Benghazi’ Trump urges Iraqi PM to protect US personnel after protesters storm embassy MORE (D-Calif.) stealing Social Security money to fund the impeachment process went viral, garnering over 4 million shares across a variety of social media platforms, according to analytics website Shared Count. 

Fadi Quran, a disinformation researcher with progressive advocacy group Avaaz, told The Hill that the group’s research showed the Pelosi article had received 258,000 and 1.38 million interactions during the House impeachment process, underlining the present and pervasive risk of disinformation during divisive political moments.

However, Quran said it’s likely that disinformation in 2020 will be “memes, pictures and videos” rather than the “‘fake news’ links or websites” that dominated the last presidential election. That’s because images laid over with text are harder for the platforms’ artificial intelligence systems to detect, and also because social media use is turning towards images more often.

“Based on everything we’ve seen, [the presidential candidates are] not prepared at all for the onslaught of disinformation that they’re going to face this year,” Quran said. 

The U.S. ambassador to Iraq will return to the embassy in Baghdad, a State Department official told The Hill on Tuesday, denying reports that the ambassador had been evacuated amid an attack by Iraqi protesters on the U.S. compound in the capital city.

According to the official, U.S. Ambassador to Iraq Matt Tueller was away from the embassy on previously scheduled personal travel as the area came under assault by protesters who got beyond heavily fortified walls, past a main door and set fire to a reception area, according to reports.

U.S. personnel are secure and there has been no breach, the official continued, and there are no plans to evacuate the embassy.

“We have made clear the United States will protect and defend its people, who are there to support a sovereign and independent Iraq,” the official said. “We are closely monitoring the situation in Iraq and call on the Government of Iraq to protect our diplomatic facilities per their obligations.”

The State Department further emphasized that it draws a distinction between the protesters who attacked the embassy and Iraqis who have risen up over the past few months in popular protests against Iranian influence in Iraq and poor economic conditions.

“The Iranian backed demonstrations in front of the U.S. Embassy should not be confused with the Iraqi protestors who have been in the streets since October to decry the corruption exported to Iraq by the Iranian regime,” the person said.

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A federal judge will allow portions of a lawsuit alleging racism at a Tesla factory in California to move forward. 

U.S. District Judge William Orrick, an Obama-appointee, decided Monday that there were still open questions over whether former employees Owen Diaz and his son, Demetric Di-az, experienced “severe and pervasive racial harassment” while working at Tesla’s factory in Fremont, Calif., in 2015 and 2016.

The Obama-appointee concluded that Diaz could pursue claims that Tesla allowed racial harassment and did not take necessary steps to combat it, according to the order. Punitive damages could be rewarded if Tesla knew about the harassment and “ratified” it, the judge wrote. 

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The trial is scheduled for May 11, Reuters reported. Tesla did not immediately respond to a request for comment.

Orrick said Diaz could also move forward with allegations against a staffing agency that sent him to the factory. Diaz worked as an elevator operator for 11 months, and his son worked as a production associate for two months, according to Reuters. 

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However, the judge did approve a motion to dismiss claims associated with the Unruh Civil Rights Act, a law forbidding discrimination — including racial discrimination — and several claims against the associated staffing agencies.

The plaintiffs, who are black, said they experienced racial epithets dozens of times as well as cartoons, including one “depicting a black face person with a bone in his hair with the caption under it saying boo,” allegedly short for “jigaboo,” a racial slur. They allege their supervisors participated in or did not stop the harassment. 

Tesla has countered the claims, saying the company “did not hesitate” to confront racism and there was no proof of “oppression, malice, or fraud,” according to Reuters. 

The plaintiffs’ lawyer Lawrence Organ, said his clients are seeking damages “in the millions,” according to news outlet. 

“Tesla is not sending a message that this kind of conduct in the workplace is not permitted,” he told Reuters.

North Korean leader Kim Jong UnKim Jong UnKim calls for ‘positive and offensive’ North Korea security protections WH national security adviser on North Korean ‘Christmas gift’: ‘We’ll have to wait and see’ North Korea holds political conference before year-end concessions deadline set for US MORE is expected to offer a “new path” in a New Year’s Day speech after the U.S. misses its deadline for denuclearization talks, Reuters reported Tuesday. 

Kim is set to discuss the country’s new plan in his address after the U.S. did not take the requested steps to lighten its stance on denuclearization. The leader suggested he would have to make adjustments if the U.S. did make his deadline when speaking for his 2019 speech.

The leader’s speech is expected to bring information from a meeting with the Workers’ Party’s 7th Central Committee that has continued since Saturday, according to state media, Reuters reported. In Monday’s meeting, Kim called for “positive and offensive measures” to preserve the country’s security. 

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“The Central Committee plenary meeting is meant to legitimize the process behind the policy decisions Kim Jong-unKim Jong UnWH national security adviser on North Korean ‘Christmas gift’: ‘We’ll have to wait and see’ North Korea holds political conference before year-end concessions deadline set for US Germans think Trump is more dangerous to world peace than Kim Jong Un and Putin: survey MORE will announce in his New Year speech,” Leif-Eric Easley, a professor at Ewha Womans University in Seoul, told Reuters. “This meeting is to provide political justification for the economic and security policies Pyongyang will pursue in 2020.”

U.S. military commanders say the “new path” forward could involve North Korea testing intercontinental ballistic missiles and nuclear bombs. U.S. national security adviser Robert O’Brien said the U.S. would be “extraordinary disappointed” if Kim took these actions.

These steps could also put North Korea’s frequently touted relationship with President TrumpDonald John TrumpSchumer renews call for witnesses to testify in impeachment trial in wake of ‘game changer’ report Tulsi Gabbard: Impeachment has ‘greatly increased the likelihood’ of Trump reelection and GOP retaking House Susan Collins says she’s ‘open’ to calling witnesses in Senate impeachment trial MORE at risk.

Military flight tracker Aircraft Spots also tracked a U.S. air force surveillance plane flying over South Korea Monday and Tuesday, Reuters reported.

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Microsoft on Monday announced that it has taken legal action against a North Korean-based cybercrime group that was using websites and other domains to attack individuals and companies in the U.S., South Korea and Japan. 

Tom Burt, the corporate vice president of consumer security and trust at Microsoft, wrote in a blog post that a case filed with the U.S. District Court for the Eastern District of Virginia, unsealed last week, allowed Microsoft to take control of 50 domains controlled by the group as well as halt cyberattacks. 

Burt wrote that the cybercrime group, known as Thallium, used a network of websites, domains and internet-connected computers to target and steal the personal information of government and university employees, think tanks, organizations focused on human rights and world peace, and individuals working in the field of nuclear proliferation.

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The cybercrime group would compromise the online accounts of victims by sending “spear phishing” emails and would then infect their computers and steal sensitive information. 

“Thallium typically attempts to trick victims through a technique known as spear phishing,” Burt wrote. “By gathering information about the targeted individuals from social media, public personnel directories from organizations the individual is involved with and other public sources, Thallium is able to craft a personalized spear-phishing email in a way that gives the email credibility to the target.” 

The fake email would encourage the victim to input their email user credentials, which would give the cybercriminals access to their accounts. Thallium also used malware viruses to infect the victim’s computer system, which, once installed, could steal data and send it to the attackers. 

“As we’ve said in the past, we believe it’s important to share significant threat activity like that we’re announcing today,” Burt wrote. “We think it’s critical that governments and the private sector are increasingly transparent about nation-state activity so we can all continue the global dialogue about protecting the internet.”

Burt strongly encouraged all Microsoft customers to enable two-factor authentication on their email accounts, enable security alerts and learn more about email phishing campaigns in order to prevent similar attacks. 

The legal action taken against Thallium marks the fourth time Microsoft has taken action against international cybercrime groups. 

The company has previously raised awareness about and targeted cybercrime groups linked to China, Russia and Iran, including announcing in October that an Iranian group known as Phosphorus had targeted the reelection campaign of President TrumpDonald John TrumpSchumer renews call for witnesses to testify in impeachment trial in wake of ‘game changer’ report Tulsi Gabbard: Impeachment has ‘greatly increased the likelihood’ of Trump reelection and GOP retaking House Susan Collins says she’s ‘open’ to calling witnesses in Senate impeachment trial MORE along with attempting to compromise thousands of other Microsoft accounts.

The number of deaths and injuries linked to a vaping disease have declined from their peak and appear to be leveling off, according to new data released Tuesday by federal health authorities.

According to the Centers for Disease Control and Prevention (CDC), 2,561 hospitalized cases have been reported in all 50 states, as well as the District of Columbia, Puerto Rico and U.S. Virgin Islands, since the summer.

As of Friday, 55 deaths have been confirmed in 27 states and the District of Columbia, the CDC said. The new numbers show the number of hospitalizations have slowed in recent weeks; prior to the most recent update, there were 2,506 hospitalized cases and 54 deaths. 

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The agency said its data seemed to show that the outbreak began in June and peaked in September, when cases were skyrocketing each week. 

Even though the number of hospitalizations has declined since the peak, the CDC said they have not returned to levels before June.

The investigation has zeroed in on vitamin E acetate, mostly found in illegal THC vaping products, as one of the main causes. 

However, the CDC cautioned that continued vigilance is necessary, as new data show that certain groups of patients released from the hospital — such as people with chronic medical conditions like cardiac disease and diabetes — are more likely to be re-hospitalized or die.

2019 was a tough year for our family so today, more than ever, I’m eager to welcome the new year. Emotionally, our thoughts and feelings need to be processed. Physically, our bodies need to find their way back to a healthy and strong place. January is therefore a perfect time to reflect, reboot, improve, clean up, make changes, make plans, set goals, and start afresh. 

I don’t set new year’s resolutions, but I do make a point of thinking about my priorities. How I can do things in a better way, and become a better person? I try to make peace with the things that bothered me during the previous year so that I can move on. Life is too short and goes by too fast.

I have a milestone birthday coming up in July, so I’ll be reflecting a little more than usual about fashion and style this month, and look forward to hearing your thoughts as you reflect with me. In the meantime, I wish you a happy, healthy and fabulous 2020 that’s full of love, laughter, fun, adventure, great style, good eats, excellent exercise, creative endeavours, and meaningful moments.