a Better Bubble™
When Andrew Gallamore clocks out of work at his job in Bonner Springs, he clicks on his phone. Sometimes, to bet. His DraftKings app makes dropping $5 or $10 on a prop bet so easy. And once he’s back home in Missouri, having even a few dollars riding on how many yards a player may […]
The post With a casino on their phones, more Kansas City gamblers risk addiction appeared first on Missouri Independent.
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In the winter of 2021, with its stock price plunging, lawsuits mounting and popular breathing machines pulled from the shelves, Philips Respironics made a surprise public announcement.
The company said the sleep apnea devices it had recalled only months earlier had undergone new safety tests and did not appear to pose a health threat to the millions of patients who relied on them to breathe.
It was a remarkable reversal for the global manufacturer, which had drawn headlines after admitting that an industrial foam placed inside the devices could break apart in heat and humidity and send potentially toxic and carcinogenic particles and fumes into the masks worn by users.
The new results, Philips said, found the machines were not expected to “result in long-term health consequences.”
But a series of emails obtained by ProPublica and the Pittsburgh Post-Gazette show the Food and Drug Administration quickly rejected those safety claims, telling Philips that the new tests failed to account for the impact on patients who had used the devices for years. The FDA also said it still considered the machines a significant health threat that could inflict severe injury or even death.
“These tests are preliminary,” the agency told Philips. “Definitive conclusions cannot yet be drawn in support of reduction in hazards.”
The FDA did not publicize its assessment, even though patients across the country were at risk and an untold number continued using their recalled machines while they waited on Philips to send replacements.
At the time, the FDA made only one public reference to the dispute — on the fourth page of a 14-page letter to Philips in May 2022. To see it, customers would have had to find it on the agency’s website and then wade through scientific language about “cytotoxicity failure,” “novel continuous sampling” and other complex concepts.
Philips went on to publicize more test results, all playing down the potential health dangers. To this day, the FDA has said little about its ongoing disagreement with the company over whether the machines were safe.
The emails over the course of 2022 were obtained by ProPublica and the Post-Gazette through a public records lawsuit filed by the news organizations against the FDA. Taken together, the exchanges reveal a startling lack of transparency by both Philips and the government while patients and their doctors struggled to make sense of one of the largest and most tumultuous medical device recalls in years.
“The bottom line is that lives were at risk,” said Dr. Bob Lowe, a former emergency room physician and public health advocate in Oregon who used one of the recalled machines. “People have a right to know and providers have a right, or really an obligation, to be fully informed. As a physician, if I don’t know what the dangers are, then I can’t protect my patients.”
Dr. Robert Lowe, a former emergency room physician and public health advocate in Oregon, used a recalled device. (Liz Moughon/ProPublica)In the emails to Philips, the FDA described a litany of concerns, notably that the company’s analysis did not consider the “real world” use of the devices, which send air directly into the noses, mouths and lungs of patients for hours at a time.
Philips had brought on independent testing labs to assess whether the chemicals and particles released into the masks of patients reached dangerous levels, but the government in its emails said the testing program was “limited in its utility and does not fully assess or account for all risks.”
“FDA has not accepted the data or Philips Respironics’ conclusions,” Denise Hampton, with the FDA’s Office of Health Technology, wrote to the company in one of the emails.
It wasn’t until October 2023 — nearly two years after Philips started promoting the favorable test results — that the FDA released a public statement about its concerns, saying that testing and analysis were not “adequate” and that Philips had agreed to conduct additional studies.
Richard Callender, a former mayor in Pennsylvania who used his sleep apnea machine for six months after the recall, said patients should have been given details far earlier.
“We deserve that. If they had concerns they should have at least informed the public,” he said. “Don’t let everybody walk around saying, ‘Hey, I’m OK because [Philips] told me they think it’s all right.’”
The FDA defended its handling of the matter, saying it released the statement in October after completing an analysis of the company’s test results. “Any health determination made by the FDA is science-driven and based on thorough analysis of the information presented to the agency,” it said.
The agency said it “has been clear” about the government’s concerns with the foam in public alerts and other communications and has maintained its position about the potential health risks.
Lowe, however, said the FDA waited far too long to publicly challenge Philips as the company repeatedly told patients that the devices were safe.
“It’s not full disclosure,” he said.
Philips did not respond to specific questions from ProPublica and the Post-Gazette, but it has previously said that the tests found the foam caused no “appreciable harm” to patients and that the company would continue to carry out additional tests.
In its emails to the FDA, Philips said that the favorable findings were based on the “worst-case chemical release” and that testing had found particles from the foam did not exceed safety levels.
While Philips continues to defend the safety of the devices, the company late last month announced it would not sell any new sleep apnea machines and other respiratory devices in the United States under an agreement with the federal government.
Days later, the FDA said it had received 561 reports of deaths associated with the machines since 2021.
From the outset of the recall, there was little debate that Philips had a serious problem: Noise-reducing foam that the company had fitted inside the devices years earlier was crumbling.
Both Philips and the FDA at the time described potential health risks for patients exposed to the material, including respiratory tract illnesses, headaches, nausea, and toxic and carcinogenic effects.
Philips, however, began to walk back its warnings in December 2021, six months after the recall began. And by the following year, the company made multiple announcements about the new test results.
In email exchanges, the FDA challenged the “significant limitations” of the company’s testing program as well as efforts to change an earlier evaluation of the health risks conducted by about a dozen company officials. The 2021 internal assessment was damning, describing the deteriorating foam and dangerous chemicals and declaring the risk to patients who used the machines “unacceptable.”
Months later, Philips turned in a modified evaluation to the FDA, lowering the threat level from “crucial” to “marginal.”
Inside Philips, scientists and others were also alarmed, criticizing the company for minimizing the health risks without carrying out comprehensive testing to determine whether the machines could inflict serious harm, according to interviews and internal communications obtained by ProPublica and the Post-Gazette.
The dispute reached the company’s highest levels. Medical director Hisham Elzayat broke ranks and refused to sign the evaluation that downgraded the risk level, according to court testimony and the internal communications.
“I haven’t seen or heard anything that makes me decide acceptable risk,” he wrote at the time.
In another message, he noted about the evaluation, “There is nothing I can do about it.”
He also wrote, “If only all this effort is steered towards fixing the problem instead of hiding it.”
Elzayat, a cardiothoracic surgeon who still works for Philips and whose differences with the company were described in a federal court hearing in October, declined to comment.
According to the court testimony, after Elzayat refused to endorse the new evaluation, he was removed from the team inside Philips that was handling the crisis and stripped of his access to data about the foam.
Another company supervisor also raised concerns, complaining about the company’s push to change the evaluation, internal communications show.
“They desperately want to make changes,” the supervisor wrote. “I am trying to limit what they are doing.”
ProPublica and the Post-Gazette are withholding the supervisor’s name because of fear of reprisals.
Another official at Philips cited similar concerns, writing about the actions by a company manager to ensure that a testing lab reported favorable results. “You wouldn’t believe the magic he worked to ensure that compound was labeled a non-risk,” the official wrote.
The debate was captured in internal communications, some of which have been turned over to the Department of Justice. The DOJ has been carrying out a criminal investigation, according to sources familiar with the probe and a document reviewed by the news organizations.
Philips, which has said it is cooperating with authorities, declined to answer questions about Elzayat’s role in the controversial evaluation of the foam.
ProPublica and the Post-Gazette have reported that the company held back more than 3,700 complaints about the foam degradation from customers and the government before announcing the recall. The news organizations recently obtained more records from the FDA that identified an additional 1,100 complaints that Philips did not turn over to the government before the recall.
Federal law requires medical device makers to submit reports about malfunctions, patient injuries and deaths to the FDA within 30 days. Philips has said the company reviewed the complaints on a case-by-case basis and gave them to the FDA after the recall out of an “abundance of caution.”
The private debate about whether the machines were safe played out as hundreds of thousands of people were left to decide whether to continue using their recalled devices while waiting for a replacement from Philips. Many reached out to members of Congress, who forwarded a series of complaints to the FDA, records show.
“Having to choose whether to continue using a life-saving device and risk further health complications or to stop using them altogether and risk death is an unthinkable decision to make,” Rep. Brian Fitzpatrick, R-Pa., wrote to the agency in 2022. “It is imperative that patients and healthcare providers have the best guidance.”
The back-and-forth between federal regulators and Philips also unfolded as longtime users of the devices and their relatives stepped forward to report illnesses, including throat, lung, esophageal and nasal cancers. Some described deaths of wives, husbands and other family members.
ProPublica and the Post-Gazette previously identified reports that described nearly 2,000 cases of cancer, 600 liver and kidney illnesses, and 17,000 respiratory ailments.
Medical experts interviewed by ProPublica and the Post-Gazette say that it may take years to determine the health consequences but that early findings are worrisome. The devices tested positive numerous times for genotoxicity, the ability of a chemical to cause cells to mutate, a process that can lead to cancer, company records show.
The biggest challenge, they said, is conducting more comprehensive testing, including an epidemiological analysis that tracks the health of people who used the machines over years.
“You would want more than lab tests to really confirm that these devices are safe,” said Kushal Kadakia, a public health researcher at Harvard Medical School who has written about the recall. “You’d want data from patients over multiple years.”
Mike Wereschagin of the Pittsburgh Post-Gazette contributed reporting.
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Almost every weekday at 7 a.m., Mexican President Andrés Manuel López Obrador holds a press conference known in Spanish as “la mañanera,” or, loosely translated, the morning show. He takes questions from reporters, but his purpose is to control the news, recounting his achievements and bashing his enemies, real and perceived — especially those in the media.
Since last week, López Obrador has focused much of his ire on an article we published on Jan. 30 about allegations that drug traffickers contributed $2 million to his first, unsuccessful presidential campaign in 2006. He dismissed the story as “completely false” and “slander.”
The president has been aggressive in attacking the story’s reporter, Tim Golden, calling him “a mercenary in the service” of the Drug Enforcement Administration, a tool of the U.S. State Department and “pawn,” among other things. “As far as I’m concerned, they should give him the prize for slander,” he said of Golden, who has twice shared the Pulitzer Prize.
On Wednesday, López Obrador challenged Golden to come to the National Palace in Mexico City to answer questions about the origins of the story, why we wrote it and the identity of his sources in the United States and Mexico.
Although Golden might enjoy the debate, he won’t be appearing on the morning show. He made extensive efforts to include López Obrador’s views before the piece ran. We contacted the president’s chief spokesperson more than a week before publication and provided a detailed summary of the story’s findings along with a series of questions. After numerous requests, the spokesperson promised a reply, but we never received one.
ProPublica has requested an interview with López Obrador about the story and the questions it raises, and we would speak with him as we would any other head of state — not for an episode of the regular mañanera segment he calls “Who’s Who in the Lies?”
I do think it’s useful to engage the president on the legitimate questions he has posed about why we are doing this reporting and how we went about it.
To recap: Our story, which was based on interviews with current and former officials and a review of government documents, disclosed the existence of a previously secret investigation by the DEA into reported donations to López Obrador’s 2006 presidential campaign by traffickers working with the so-called Sinaloa Cartel.
The case began when a Mexican drug lawyer working as an informant for the DEA reported in 2010 that he had participated in the meeting at which the donations were first negotiated, officials said. He reported having given most of the agreed-on funds to an operative in López Obrador’s 2006 campaign, Mauricio Soto Caballero. The informant then enticed Soto to come in on a small-time cocaine deal. DEA agents arrested Soto in McAllen, Texas, and he agreed to work undercover for the Americans to stay out of federal prison.
Ultimately, three other witnesses, including Soto, confirmed the drug lawyer’s account to the DEA, officials said. To gather more evidence for a possible corruption case, the DEA had Soto surreptitiously record two conversations with the man to whom he said he had given most of the traffickers’ money, Nicolás Mollinedo Bastar, one of López Obrador’s closest aides.
Justice Department prosecutors reviewed the tapes and found them incriminating but not decisive, people familiar with the case said. DEA agents wanted to go forward with a more elaborate sting operation inside Mexico, but DOJ officials rejected that plan in late 2011, in part over concerns that even a successful prosecution would be viewed by Mexicans as egregious American meddling in their politics.
The case was closed and, to our knowledge, no further investigation of López Obrador or his inner circle’s possible links to drug traffickers was pursued by U.S. investigators.
(Soto did not respond to our repeated questions about his role in the U.S. investigation, but he denied in recent interviews that he acted as a confidential source or taped his friend and colleague Mollinedo. In an interview, Mollinedo told us he never received donations from drug traffickers, disputed that López Obrador would ever tolerate such corruption and said he knew nothing of any U.S. investigation involving his friend Soto.)
López Obrador was elected president in 2018 after promising a turn away from confrontation with Mexico’s powerful crime groups. He called the policy “Hugs, not bullets” and immediately began to scale back counterdrug cooperation with the United States.
Some critics of our reporting have asked why we pursued an allegation of corruption that dates back to 2006. It’s a fair question. We viewed this as a case study of the conflicting pressures faced by U.S. officials when they learn of possible corruption in Mexico. While some American officials feel that policing government corruption should be a Mexican responsibility, others note that government collusion has been a crucial element (along with a porous 2,000-mile border and a vast illegal drug market in the United States) fueling the drug gangs’ rise as a global criminal force.
The power of those gangs, which lord over large swaths of Mexican territory and extort businesses across the economy, has become a growing national security problem for both countries. In the United States, annual deaths from drug overdoses have surged over 100,000 in recent years. Hugs notwithstanding, criminal violence in Mexico remains at historic levels. After more than 15 years and $3.5 billion dollars in U.S. aid, bilateral efforts to overhaul Mexico’s criminal justice system have faltered badly.
Washington officials’ ambivalence in the face of Mexico’s corruption problem has become even more acute as immigration has taken center stage in American politics: U.S. officials understand that López Obrador’s administration could react to criminal charges against its officials by easing efforts to stop migrants at the border.
While it might disappoint López Obrador, we do not reveal the identities of the present and former government officials who speak with us for these stories. But we can offer some context on the latest article. This was not an orchestrated leak; the Biden administration officials with whom we spoke were uniformly dismayed that it was going to appear. A spat with a Mexican president — much less any threat of conflict on the immigration front — is not a backdrop they’d like to see for a 2024 presidential election.
López Obrador’s attacks from the palace podium have been personal and vituperative. So here are a few facts. Golden has been reporting on Mexico for three decades, first as The New York Times bureau chief in Mexico City and then as an investigative reporter for the Times and ProPublica. He began working on this story months ago, and the details emerged only from dozens of interviews and internal documents.
López Obrador has advanced multiple theories about how this story came to be. This week, he suggested that Golden was somehow in cahoots with the discredited former President Carlos Salinas de Gortari, whom he covered in the early 1990s. While Golden did have good sources inside the government in those days, he also produced dozens of deeply reported stories about the explosion of the drug trade under Salinas, the growing shadow of Mexican corruption and the failure of the United States to deal effectively with either problem. That work continued during the tenure of Salinas’s chosen successor, Ernesto Zedillo, whose administration also complained about stories that exposed allegations of high-level corruption.
Some in Mexico have speculated around the fact that similar stories about drug traffickers’ contributions to the 2006 campaign appeared in three foreign outlets simultaneously. Surely, they argue, that is clear circumstantial evidence of a coordinated U.S. campaign to leak information that might undermine the Mexican government.
The truth, as it so often is, is far more mundane. Early in our reporting, we realized that a respected U.S. news organization, InSight Crime, was pursuing the same allegations. Sometimes we collaborate — or compete — in such circumstances. In this case we agreed with Insight Crime that we would each work independently to produce the most thorough and careful stories we could, but coordinate our publication date. We delayed publication and rewrote our stories in order to address a request from the DEA that we not name any confidential government sources.
As sometimes happens, though, a Mexican reporter who writes for the German outlet Deutsche Welle published her own account of the donations and named Soto as a DEA source. With that information public, InSight Crime and ProPublica went ahead and included it in our stories.
Within hours, López Obrador was assailing all three reporters as “vile slanderers.”
The tactic of attacking reporters who reveal uncomfortable truths is as old as democracy itself. But the advent of social media has taken the power of attacks on journalists to new heights. Politicians like López Obrador can now use their platforms to say whatever they want about a reporter and then stand back as armies of friends and bots amplify the message across the internet.
That experience can be difficult for American reporters. But it is a deadly serious business in Mexico, where journalists who investigate organized crime and official corruption are killed with impunity. According to the Committee to Protect Journalists, more than 100 Mexican reporters, editors and photographers have been killed just since 2010. The 13 killed in 2022 represented an all-time high.
We hope López Obrador will grant us an interview, but we will continue to write about Mexican corruption and U.S. policy either way.
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