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By Adiel Kaplan, Kalen Goodluck, Kaitlin Sullivan and Pauliina Siniauer
After Teresa Hershey nearly died from complications of a hysterectomy, she wanted future patients to know about the potential dangers of choosing robotic surgery for the operation. In 2013, the California woman added a detailed account of how the robot that operated on her had burned a hole in her bowels to a database maintained by the Food and Drug Administration.
The database is meant to warn the medical community about the risks associated with medical devices. Hershey’s was one of hundreds of similar accounts about the same robotic device.
But earlier this year, the FDA made a rule change that could curtail that database, which was already considered to be of limited scope by medical researchers and the FDA itself.
The new rule, which had been sought by medical device manufacturers, opens the door for a decrease in reported information for nearly nine out of 10 device categories, an NBC News analysis found. It could allow manufacturers to submit quarterly summarized reports for similar incidents, rather than individual reports every time malfunctions occur, meaning there will be much less detail about individual cases.
“They’re taking away the detailed reports,” said Hershey, who is now an advocate, working with other victims harmed by devices. She sued the maker of the robot, and the suit was settled in May. “If they take that out, we’re not going to know what’s going on. Why do we even have the reports in the first place?”
The new rule is one of several regulatory changes favoring the medical device industry that have been proposed and enacted since the beginning of the Trump administration. They are part of a decades-long campaign to decrease U.S. regulation of the industry — a massive global business that has existed for years with minimal international scrutiny.
An NBC News analysis of the 10 largest publicly traded medical device companies in the U.S. found that since the start of the Trump administration, the companies have spent more than $36.5 million on efforts to influence rules and legislation. Some of these companies manufacture a variety of medical products, including pharmaceuticals and lab equipment, but four of the 10 exclusively manufacture devices and lobbying disclosures for all 10 emphasize efforts to influence policy around devices.
Building a presence in Washington
The medical device industry was worth $405 billion worldwide in 2017, according to an Accenture market analysis. Despite its size, the medical device industry has only a patchwork of international oversight, even though when things go wrong with a device, the consequences can be serious.
But the single largest medical device market in the world is the U.S., worth an estimated $156 billion in 2017, according to the U.S. Department of Commerce. As the medical device market has boomed over the past several decades, the industry has built a sizable presence in Washington, D.C.
Many medical device companies have built sophisticated lobbying arms, often employing their own team of lobbyists in addition to hiring outside firms for specific issues. Several of the largest companies used between 15 and 50 lobbyists in 2017 alone, an analysis by the Center for Responsive Politics (CRP) found.
There are also two main trade groups for the industry to which device makers contribute membership fees to, both of which pack a hefty lobbying punch on their own. Since the start of 2017, the Advanced Medical Technology Association (AdvaMed), the older and larger group, has spent more than $6 million and the Medical Device Manufacturers Association (MDMA) has spent nearly $2.6 million. The groups’ policy goals echo those that individual companies list on their lobbying disclosures, among them: decreasing taxes on devices, increasing insurance coverage and reimbursement and the FDA’s approval process for bringing a device to market.
The medical device lobbying effort is vast, with lobbyists seeking to be heard on Medicare and Medicaid reimbursement codes, device purchasing policies at the Veterans Administration, even cybersecurity and trade issues. Companies regularly lobby Congress, but also target agencies and offices across the executive branch, from the FDA to the Center for Medicare and Medicaid and the National Security Council.
Altogether, the industry has spent more than $20 million per year for the past five years lobbying the federal government, according to an analysis of campaign finance and lobbying data from CRP.
With the change in administration in 2017, that spending increased to more than $26 million, $2.2 million more than its highest level in any of the previous four years. Based on disclosures from the first three quarters of the year, medical device lobbying in 2018 is on pace to exceed 2017 levels.
An industry spokesperson noted that the U.S. pharmaceutical industry spends more heavily on lobbying than the device industry. Big Pharma, which was worth more than $453 billion in the U.S. in 2017, spent more than $171 million the same year — more than six times as much as the device industry, according to a Statista market analysis.
The lobbying resources of the device industry far outweigh those of consumer and patient advocates, which are often on the other side of regulatory debates on Capitol Hill.
Very few advocacy groups spend time lobbying on devices, said Dr. Diana Zuckerman, a former HHS official under Obama and president of the National Center for Health Research, a nonprofit advocacy organization based in Washington.
“When we’ve talked to congressional staff about this,” she said, “they say things like, ‘Well, we’re getting calls every day, all day long from various device companies or their lawyers,’ and the nonprofits are basically going to the Hill for visits a few hours a year.”
Zuckerman’s group is one of about a half dozen to lobby on devices over the past few years. Each of the largest spends no more than a few-hundred-thousand dollars annually to lobby on devices and all other consumer issues, according to their federal lobbying disclosures.
Trial lawyer groups, which the device industry spokesperson noted often sue device makers, also spent less than one third of what the device industry did in 2017, a CRP analysis found.
NBC News contacted the three companies that have spent the most on lobbying in the past five years to ask about their lobbying efforts. Baxter International and Abbott Laboratories did not comment. Medtronic said, “Despite the company nearly doubling in size, our lobbying-related efforts over the last 10 years have remained relatively stable.”
Previously, Abbott, Medtronic and a half-dozen other international device makers told the International Consortium of Investigative Journalists that they conduct business with the highest ethical standards, adhere to all laws and have rigorous programs to prevent employee misconduct.
In a statement to NBC News, Mark Leahey, president of MDMA, said, “As millions of Americans benefit daily from the more than 190,000 different medical devices available and in use in the United States, our members continue to work with patient groups and policy makers to advance policies that promote improved access for patients and providers. This dynamic innovation ecosystem remains committed to developing the cures and therapies of tomorrow, while reducing adverse events and learning from ongoing research and each patient’s experience.”
Obama versus Trump
During its eight-year tenure, the Obama administration permitted some deregulation but also instituted the first FDA product ban since the 1980s.
Beginning in 2014, warning letters to industry began to drop steeply and approval of new devices to rise. By 2017, the number of FDA warning letters to device manufacturers about product safety had dropped to nearly 80 percent less than those issued in 2010, while approval numbers for new devices were more than three times as high as at the beginning of the decade. The FDA says the decrease in warning letters is due to a more interactive approach to working with violative companies, and the uptick in approvals is due to an increase in staffing and efficiency.
Under Obama, some FDA regulators responsible for overseeing the device industry pushed for deregulation. Administrators largely kept it in check, said Peter Lurie, an FDA associate commissioner during the Obama administration.
“It was accompanied by very heavy lobbying on Capitol Hill as well,” said Lurie. Priorities included faster device approval times and decreasing taxes.
During Obama’s final year in office, the FDA banned its first device in more than 30 years — a type of surgical glove — and proposed a ban on a home shock collar for behavior modification. That ban is still pending.
The industry successfully pushed for changes in a proposed regulation on unique device identifiers — identification codes for individual devices, similar to automotive vehicle identification numbers, and won the suspension of a tax on medical devices created to help fund the Affordable Care Act.
“Now with the advent of the Trump administration,” said Lurie, “the deregulatory gloves are off and we’re seeing a number of the device industry’s most desired objectives come to fruition.”
President Trump vowed to cut regulations across the government by 75 percent when he came into office.
Since he took office, the industry has successfully pushed for making device alternatives to opioids easier to pay for. It also negotiated a decrease in approval times for certain devices.
In 2002, Congress instituted a program in which the device industry pays “user fees” to fund the FDA office that oversees it, amounts which are agreed upon in negotiations between industry and the regulator every five years. Its first year, the fees provided 10 percent of funding for the device center, but by 2018, the fees brought in more than $153 million, providing more than 35 percent of the center’s budget.
“It’s carefully negotiated for weeks and months at a time,” said Jack Mitchell, former director of Special Investigations for the FDA. “And there’s a laundry list of things that industry gets FDA to agree to and that they’re paying for.”
If the most recent agreement, negotiated in 2017, had not gone through by the deadline, the agency would have legally been required to temporarily layoff at least one third of its device center staff. The final agreement included a decrease in approval time for certain devices.
“We do not believe user fee funding has influenced our decision making,” the FDA said in a statement, noting that other parts of the FDA are also funded by user fees.
The agency also noted that it held meetings with patient stakeholders in addition to industry when negotiating the user fee agreement, saying, “Patients are a critical part of the user fee process.”
The FDA emphasized that it does not always agree with the industry, citing as examples its support of legislation that makers of reusable devices provide instruction on how to prevent bacterial contamination with devices and of including device identifier codes in insurance claims forms.
‘It makes things easier for industry’
The changes to how adverse events are reported was also an industry success.
The FDA database in which Hershey entered a report of her near fatal surgery complication back in 2013, called the Manufacturer and User Facility Device Experience Database, includes more than 750,000 incidents per year. The adverse events range from minor malfunctions to patient deaths linked to products being used around the world.
Despite its size, it’s widely accepted that the database is only a partial picture of the full scale of device complications.
The rule went into effect in August. The FDA said in a statement in November that though the reports are valuable, they were never meant to be sole source for determining if a device is causing harm.
“This type of reporting system has notable limitations,” said the FDA, “including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”
Patients like Hershey can report adverse events to the database themselves, but few know to do so. Companies are required to report the events. They don’t always do so. The FDA said a third of all warning letters to device makers were to companies that failed to meet rules for reporting complications with devices.
The more companies that fail to file properly, the less the database accurately reflects what is happening to patients with devices.
Under the rule change, companies could be allowed to submit quarterly summarized reports for similar incidents, rather than individual reports each time malfunctions occur. Previously, qualified manufacturers could submit summarized reports if they filed a request with the agency. Now they can do so without making a request.
“[The database] is the way we’ve learned about some very serious health issues,” said Rita Redberg, a cardiologist at the University of San Francisco who studies adverse events like Hershey’s. “It’s the most widespread and publicly available database for adverse events, which is extremely important for patient safety.”
In a public comment in support of the rule change, AdvaMed called the change a “commonsense approach” that will reduce the volume of reports manufacturers need to submit to the FDA and streamline the information the FDA receives about malfunctions.
“This process will actually make it easier for third parties to assess the malfunction data in [the database],” said Greg Crist, a spokesperson for AdvaMed. “Comparing the old alternative summary reporting program to this new initiative is comparing apples to oranges.”
In response to public comments that critical report information would be lost with the change in reporting, the FDA wrote in the published rule that, “We do not believe there will be an adverse impact on the content of information provided to FDA.”
In a statement, the agency said the new program “streamlines the process for reporting of device malfunctions and allows us to more efficiently detect potential safety issues and identify trends. It also frees up resources to better focus on addressing the highest risks.”
But Redberg, the cardiologist, is worried that the new rule change will make searching an already unwieldy database more difficult, decreasing the ability of researchers and the public to search for misfiled reports or see accurate numbers of adverse events.
“It makes things easier for industry, it makes things worse for patients,” she said. “I really think it’s a public health crisis. We have more and more devices in use, and for many of them we really have no idea how safe they are because we don’t have accurate reporting.”
NBC News probed medical device alerts around the world as part of a global project organized by the International Consortium of Investigative Journalists, a news organization notable for its work on the Panama Papers, to examine the medical device industry. More than 250 reporters in 36 countries worked on stories that began publishing Nov. 25.
Andrew W. Lehren contributed.
Wells Fargo, TD Bank have already given Trump-related financial documents to Congress
By Leigh Ann Caldwell and Alex Moe
WASHINGTON — A key congressional committee has already gained access to President Donald Trump’s dealings with two major financial institutions, two sources familiar with the House probe tell NBC News, as a court ruling Wednesday promised to open the door for even more records to be handed over.
Wells Fargo and TD Bank are the two of nine institutions that have so far complied with subpoenas issued by the House Financial Services Committee demanding information about their dealings with the Trump Organization, according to the sources. The disclosures by these two banks haven’t been previously reported. Both TD Bank and Wells Fargo declined to comment for this story.
Wells Fargo provided the committee with a few thousand documents and TD Bank handed the committee a handful of documents, according to a source who has seen them. The committee, led by Rep. Maxine Waters, D-Calif., is especially interested in the president’s business relationship with Russia and other foreign entities.
Appearing on MSNBC’s “Hardball” Wednesday, Waters said “we don’t have information to share with you at this time about what we’ve learned from the documents.”
A federal judge ruled Wednesday that two other banks — Deutsche Bank and Capital One — can hand over financial documents related to their dealings Trump and his businesses to Congress. The Trump family had sued to prevent those two banks from complying with the congressional subpoena and the ruling paves the way for the committee to now have access to years of financial records from at least four financial institutions.
The documents that have been provided so far are a fraction of those requested by Waters, whose committee has also sent subpoenas to Citigroup, Morgan Stanley, Royal Bank of Canada, Bank of America and JP Morgan Chase. The Royal Bank of Canada is in the process of complying with the subpoena, according to a source. The other banks have missed the subpoena deadline of May 6.
The development comes as House Democrats are internally debating whether to move forward with launching an impeachment inquiry of the president or not.
Deutsche Bank has been the Trump Organization’s biggest lender, financing more than $2 billion in loans to the president during his business career, and he still owes the bank at least $130 million, according to Trump’s latest financial disclosures.
The subpoenas, details of which have not been released to the public, are predicated on the notion that Congress has access to the information under the Bank Secrecy Act, which allows Congress access to financial information to search for money laundering, according to a person who has seen them.
“The potential use of the U.S. financial system for illicit purposes is a very serious concern,” Waters said in April when she issued the subpoenas. “The Financial Services Committee is exploring these matters, including as they may involve the President and his associates, as thoroughly as possible pursuant to its oversight authority, and will follow the facts wherever they may lead us.”
Neither the office for chairwoman Waters nor the committee’s ranking member, Patrick McHenry, R-N.C., responded to requests for comment.
The Waters probe is just one of numerous confrontations between House Democrats and the president over his financial information.
The receipt of documents suggests progress for House Democrats who have often been frustrated in their efforts to, in some cases, conduct oversight but they have had progress in recent days. U.S. District Judge Amit Mehta this week said that Congress has the legal authority to request information from the president’s personal accounting firm Mazars USA.
An NBC News analysis finds that at least 14 different Democratic-led House committees are investigating various aspects of Trump and his presidency, with 50 different inquiries that are seeking documents from the executive branch or outside entities.
Much of the focus for House Democrats has been on efforts across multiple committees to gain access to an unredacted version of the Mueller report, which the Justice Department recently moved to block after Trump asserted executive privilege.
While lawmakers have been stymied in obtaining additional documentation that could be central to an obstruction of justice case against the president or members of his administration, accessing bank records could provide new momentum for an investigation centered around questions of whether foreign individuals or governments hold financial leverage over the president, his family or his businesses.
CORRECTION (May 23, 2019, 9:35 a.m. ET): An earlier version of this article misstated the list of financial institutions that have received a subpoena from the House Financial Services Committee. Bank of America should have been included on that list.
CORRECTION (May 23, 2019, 10 a.m. ET): An earlier version of this article misspelled the first name of a federal judge. He is Amit Mehta, not Ahmit. It also misspelled the name of one of the banks mentioned. It is Capital One, not Capitol One.
In another attack, Trump tweets video of Pelosi tripping over words
By Phil Helsel
President Donald Trump on Thursday night tweeted out an edited video showing Nancy Pelosi stumbling over her words, escalating the personal attacks he has made against the Democratic House Speaker.
The video, apparently from a segment on Fox Business’ “Lou Dobbs Tonight,” features portions of a 20-minute news conference Pelosi held Thursday in a montage that lasts about 30 seconds. It shows her tripping over her words. At one point in the video, a moment is repeated several times.
Trump tweeted the video hours after he called Pelosi “crazy” and said “She is not the same person. She has lost it.” It comes a day after Trump cut short a meeting with Pelosi and Senate Minority Leader Chuck Schumer because he is frustrated with congressional efforts to investigate his administration.
Pelosi’s press secretary did not return a phone call seeking comment Thursday night.
Video on CSPAN of Pelosi’s full weekly legislative briefing with reporters on Thursday shows Pelosi making the same stumbles seen in the clip tweeted by the president. The briefing lasted about 20 minutes.
The tweet by the president comes after The Washington Post published a story about a different video circulating on social media of Pelosi at a Center for American Progress event. The video was altered to make it sound as if she was slurring her words, The Post reported.
Hany Farid, a computer-science professor and digital-forensics expert at University of California, Berkeley, told The Post that there was no doubt that video had been altered.
But said he believed the video Trump tweeted Thursday had not been slowed down.
“Unlike the video referred to in The Washington Post article, I don’t believe that this video montage was slowed down. This montage, however, is highly deceptive as it compiles in rapid succession relatively small verbal stumbles in an attempt to portray Speaker Pelosi as stumbling through her press conference,” Farid told NBC News.
“The original C-Span video clearly shows that this montage that the president tweeted is not an accurate depiction of her press conference,” Farid said.
Drew Hammill, Pelosi’s deputy chief of staff, on Twitter called the video that Trump tweeted Thursday night “doctored” and referred to the Post article. Pelosi’s daughter Christine tweeted: “Fake video altered for speed.”
A spokesperson for Fox Business Network, on which “Lou Dobbs Tonight” airs, said in a statement that “The FOX Business segment featuring clips from Speaker Pelosi’s speech today did not slow down any aspect of her address.”
Pelosi has also taken swipes at Trump. “When the ‘extremely stable genius’ starts acting more presidential, I’ll be happy to work with him on infrastructure, trade and other issues,” Pelosi tweeted earlier Thursday.
The reference is to a comments Trump has made about being a “very stable genius.”
And before the infrastructure meeting collapsed Wednesday, Pelosi accused Trump of engaging “in a cover-up.”
The president denied the allegation. “I don’t do cover-ups,” he said from the Rose Garden.
Trump lashes out at Rex Tillerson for saying Putin out-prepared him
By Allan Smith
President Donald Trump lashed out at Rex Tillerson on Thursday morning after his former secretary of state reportedly told a House committee that the president was ill-prepared for a 2017 meeting with Russian President Vladimir Putin.
“Rex Tillerson, a man who is ‘dumb as a rock’ and totally ill prepared and ill equipped to be Secretary of State, made up a story (he got fired) that I was out-prepared by Vladimir Putin at a meeting in Hamburg, Germany,” Trump tweeted. “I don’t think Putin would agree. Look how the U.S. is doing!”
The tweet followed a Washington Post report that Tillerson told the House Foreign Affairs Committee that Putin out-prepared Trump for the meeting at the 2017 G-20 summit. Tillerson said Putin’s higher level of preparation put Trump at a disadvantage during the meeting.
The U.S. had anticipated a shorter meeting between the two leaders, but it instead turned into a two-hour plus discussion of geopolitical issues, committee aides told the Post. Tillerson spoke before the committee for seven hours in a closed-door session on Tuesday.
“We spent a lot of time in the conversation talking about how Putin seized every opportunity to push what he wanted,” a committee aide told the Post. “There was a discrepancy in preparation, and it created an unequal footing.”
Tillerson spoke with a bipartisan group of lawmakers and staff at the request of the panel’s chairman, Rep. Eliot Engel, D-N.Y., the newspaper reported. Unlike Trump’s solo meeting with Putin in Helsinki last summer, advisers — including Tillerson — were present alongside him at the meeting with the Russian president in Germany.
Tillerson and Trump had sparred for months before the president fired him in March of last year. The former secretary of state nearly resigned in the summer of 2017 amid mounting policy disputes and clashes with the White House, NBC News reported, citing senior administration officials. As tensions came to a head, Tillerson called Trump a “moron” following a meeting at the Pentagon with Cabinet officials and members of Trump’s national security team, three officials familiar with the incident said.
In December, Tillerson told CBS News that Trump was “undisciplined,” didn’t read much and tried to do things that would violate the law. In response, Trump said Tillerson “didn’t have the mental capacity needed” to be secretary of state.
“He was dumb as a rock and I couldn’t get rid of him fast enough,” Trump tweeted. “He was lazy as hell.”
In hiring Tillerson to run the State Department, Trump pointed to the former Exxon Mobil executive’s “vast experience at dealing successfully with all types of foreign governments” and called him “a world class player and dealmaker.”
“He will be a star,” Trump tweeted after Tillerson was sworn in.
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