Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, September 23, 2016

FDA Manipulates the Media: Scientific American

How the FDA Manipulates the Media
The U.S. Food and Drug Administration has been arm-twisting journalists into relinquishing their reportorial independence, our investigation reveals. Other institutions are following suit

Credit: Sébastien Thibault
It was a faustian bargain—and it certainly made editors at National Public Radio squirm.
The deal was this: NPR, along with a select group of media outlets, would get a briefing about an upcoming announcement by the U.S. Food and Drug Administration a day before anyone else. But in exchange for the scoop, NPR would have to abandon its reportorial independence. The FDA would dictate whom NPR's reporter could and couldn't interview.
“My editors are uncomfortable with the condition that we cannot seek reaction,” NPR reporter Rob Stein wrote back to the government officials offering the deal. Stein asked for a little bit of leeway to do some independent reporting but was turned down flat. Take the deal or leave it.
NPR took the deal. “I'll be at the briefing,” Stein wrote.
Later that day in April 2014, Stein—along with reporters from more than a dozen other top-tier media organizations, including CBS, NBC, CNN, the Washington Post, the Wall Street Journal and the New York Times—showed up at a federal building to get his reward. Every single journalist present had agreed not to ask any questions of sources not approved by the government until given the go-ahead.
“I think embargoes that attempt to control sourcing are dangerous because they limit the role of the reporter whose job it is to do a full look at a subject,” says New York Times former public editor Margaret Sullivan. “It's really inappropriate for a source to be telling a journalist whom he or she can and can't talk to.” Ivan Oransky, distinguished writer in residence at New York University's Journalism Institute and founder of the Embargo Watch weblog, agrees: “I think it's deeply wrong.”
This kind of deal offered by the FDA—known as a close-hold embargo—is an increasingly important tool used by scientific and government agencies to control the behavior of the science press. Or so it seems. It is impossible to tell for sure because it is happening almost entirely behind the scenes. We only know about the FDA deal because of a wayward sentence inserted by an editor at the New York Times. But for that breach of secrecy, nobody outside the small clique of government officials and trusted reporters would have known that the journalists covering the agency had given up their right to do independent reporting.
Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story. At the same time, the FDA cultivates a coterie of journalists whom it keeps in line with threats. And the agency has made it a practice to demand total control over whom reporters can and can't talk to until after the news has broken, deaf to protests by journalistic associations and media ethicists and in violation of its own written policies.
By using close-hold embargoes and other methods, the FDA, like other sources of scientific information, are gaining control of journalists who are supposed to keep an eye on those institutions. The watchdogs are being turned into lapdogs. “Journalists have ceded the power to the scientific establishment,” says Vincent Kiernan, a science journalist and dean at George Mason University. “I think it's interesting and somewhat inexplicable, knowing journalists in general as being people who don't like ceding power.”
The press corps is primed for manipulation by a convention that goes back decades: the embargo. The embargo is a back-room deal between journalists and the people they cover—their sources. A source grants the journalist access on condition that he or she cannot publish before an agreed-on date and time.
A surprisingly large proportion of science and health stories are the product of embargoes. Most of the major science journals offer reporters advance copies of upcoming articles—and the contact information of the authors—in return for agreeing not to run with the story until the embargo expires. These embargoes set the weekly rhythm of science coverage: On Monday afternoon, you may see a bunch of stories about the Proceedings of the National Academy of Sciences USA published almost simultaneously. Tuesday, it's the Journal of the American Medical Association. On Wednesday, it's Nature and the New England Journal of Medicine. Science stories appear on Thursday. Other institutions have also adopted the embargo system. Federal institutions, especially the ones science and health journalists report on, have as well. Embargoes are the reason that stories about the National Laboratories, the National Institutes of Health and other organizations often tend to break at the precisely same time.
Embargoes were first embraced by science reporters in the 1920s, in part because they take the pressure off. After all, when everybody agrees to publish their stories simultaneously, a reporter can spend extra time researching and writing a story without fear of being scooped. “[Embargoes] were created at the behest of journalists,” says Kiernan, who has written a book, Embargoed Science, about scientific embargoes. “Scientists had to be convinced to go along.” But scientific institutions soon realized that embargoes could be used to manipulate the timing and, to a lesser extent, the nature of press coverage. The result is a system whereby scientific institutions increasingly control the press corps. “They've gotten the upper hand in this relationship, and journalists have never taken it back,” Kiernan says.
The embargo system is such an established institution in science journalism that few reporters complain or even think about its darker implications, at least until they themselves feel slighted. This January the California Institute of Technology was sitting on a great story: researchers there had evidence of a new giant planet—Planet Nine—in the outer reaches of our solar system. The Caltech press office decided to give only a dozen reporters, including Scientific American's Michael Lemonick, early access to the scientists and their study. When the news broke, the rest of the scientific journalism community was left scrambling. “Apart from the chosen 12, those working to news deadlines were denied the opportunity to speak to the researchers, obtain independent viewpoints or have time to properly digest the published research paper,” complained BBC reporter Pallab Ghosh about Caltech's “inappropriate” favoritism in an open letter to the World Federation of Science Journalists.
When asked about why Caltech chose to release the news only to a select group of reporters, Farnaz Khadem, Caltech's head of communications, stated that she is committed to being “fair and transparent” about how and when Caltech shares news with journalists. She then refused to talk about the Planet Nine incident or embargoes or press strategy, and she would not grant access to anyone at Caltech who might talk about such matters. As a consequence, it is hard to know for certain why Caltech decided to share the news with only a select group of reporters. But it is not hard to guess why journalists such as Ghosh were excluded. “It wasn't that they were not good enough or not liked enough,” Kiernan speculates. “There was a real effort here to control things, making sure that the elite of the elite covered this story and covered it in a certain way, which would then shape the coverage of all other journalists. It's very clearly a control effort.”
Caltech is not the only institution that steers coverage by briefing a very small subset of reporters. (As I was writing this piece, I received a note from a U.S. Air Force press officer offering a sneak preview of video footage being offered to “a select number of digital publications.”) For years the FDA has been cultivating a small group of journalists who are entrusted with advance notice of certain events while others are left out in the cold. But it was not the game of favorites that ignited a minor firestorm in the journalism community in January 2011—it was the introduction of the close-hold embargo.
Like a regular embargo, a close-hold embargo allows early access to information provided that attendees not publish before a set date and time. In this case, it was a sneak peek at rules about to be published regarding medical devices. But there was an additional condition: reporters were expressly forbidden from seeking outside comment. Journalists would have to give up any semblance of being able to do independent reporting on the matter before the embargo expired.
Even reporters who had been dealing with the FDA for years were incredulous. When one asked the agency's press office if it really was forbidding communications with outside sources, Karen Riley, an official at the FDA, erased all doubt. “It goes without saying that the embargo means YOU CANNOT call around and get comment ahead of the 1 P.M. embargo,” she said in an e-mail.
“Actually it does need some saying, since this is a new version of a journalistic embargo,” wrote Oransky in his Embargo Watch blog. Without the ability to contact independent sources, he continued, “journalists become stenographers.” Kiernan echoes the sentiment: “[When] you can't verify the information, you can't get comment on the information. You have to just keep it among this group of people that I told you about, and you can't use it elsewhere. In that situation, the journalist is allowing his or her reporting hands to be tied in a way that they're not going to be anything, ultimately, other than a stenographer.”
The Association of Health Care Journalists (AHCJ), of which I am a member, publicly objected to the close-hold embargo, noting that it “will be a serious obstacle to good journalism. Reporters who want to be competitive on a story will essentially have to agree to write only what the FDA wants to tell the world, without analysis or outside commentary.” Faced by this opposition, the agency quickly backtracked. After a meeting with AHCJ leaders, Meghan Scott, then the agency's acting associate commissioner for external affairs, wrote: “Prior to your inquiry, the FDA did not have a formal news embargo policy in place.” The FDA was now establishing new ground rules that “will better serve the media and the public.”
Initially published online in June 2011, the FDA's new media policy officially killed the close-hold embargo: “A journalist may share embargoed material provided by the FDA with nonjournalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third party to uphold the embargo.” Due diligence would always be allowed, at least at the FDA.
Health and science journalists breathed a sigh of relief. The AHCJ expressed gratitude that the FDA had changed its tune, and Oransky's Embargo Watch congratulated the agency for backing down: “For doing the right thing, the FDA has earned a spot on the Embargo Watch Honor Roll. Kudos.” And the FDA had cleared up the misunderstanding and affirmed that it was committed to “a culture of openness in its interaction with the news media and the public.”
In reality, there was no misunderstanding. The close-hold embargo had become part of the agency's media strategy. It was here to stay—policy or no policy.
It is hard to tell when a close-hold embargo is afoot because, by its very nature, it is a secret that neither the reporters who have been given special access nor the scientific institution that sets up the deal wants to be revealed. The public hears about it only when a journalist chooses to reveal the information.
We have a few rare instances where journalists revealed that close-hold embargoes were being used by scientists and scientific institutions after 2011. In 2012 biologist Gilles-Eric Séralini and his colleagues published a dubious—later retracted and then republished—paper purportedly linking genetically modified foods to cancer in rats. They gave reporters early access under a close-hold embargo, quite likely to hamstring the reporters' ability to explore gaping holes in the article, a situation science journalist Carl Zimmer described as “a rancid, corrupt way to report about science.” In 2014 the U.S. Chemical Safety and Hazard Investigation Board (also called the CSB) released a report to journalists under a close-hold embargo. When challenged, the then managing director of the CSB, Daniel Horowitz, told Oransky's Embargo Watch that the close-hold embargo was used “on the theory that this would provide a more orderly process.” He then stated that the board was going to “drop the policy in its entirety for future reports.” Privately, however, a CSB public affairs specialist noted in an e-mail, “Frankly, I wish we did have more stenographers out there. Government agencies trying to control the information flow is an old story, but the other side of the story is that government agencies that do good work often have a difficult time getting their story told in an era of journalistic skepticism and partisan bickering and bureaucratic infighting.”
Also in 2014 the Harvard-Smithsonian Center for Astrophysics (CfA) used a close-hold embargo when it announced to a dozen reporters that researchers had discovered subtle signals of gravitational waves from the early universe. “You could only talk to other scientists who had seen the papers already; we didn't want them shared unduly,” says Christine Pulliam, the media relations manager for CfA. Unfortunately, the list of approved scientists provided by CfA listed only theoreticians, not experimentalists—and only an experimentalist was likely to see the flaw that doomed the study. (The team was seeing the signature of cosmic dust, not gravitational waves.) “I felt like a fool, in retrospect,” says Lemonick, who, as one of a dozen or so chosen journalists, covered the story for Time (at the time, he was not on the staff of Scientific American).
The FDA, too, quietly held close-hold embargoed briefings, even though its official media policy forbids it. Without a source willing to talk, it is impossible to tell for sure when or why FDA started violating its own rules. A document from January 2014, however, describes the FDA's strategy for getting media coverage of the launch of a new public health ad campaign. It lays out a plan for the agency to host a “media briefing for select, top-tier reporters who will have a major influence on coverage and public opinion of the campaigns.… Media who attend the briefing will be instructed that there is a strict, close-hold embargo that does not allow for contact with those outside of the FDA for comment on the campaign.”
Why? The document gives a glimpse: “Media coverage of the campaign is guaranteed; however, we want to ensure outlets provide quality coverage of the launch,” the document explains. “The media briefing will give us an opportunity to shape the news stories, conduct embargoed interviews with the major outlets ahead of the launch and give media outlets opportunities to prepare more in-depth coverage of the campaign launch.”
Ten reporters—from the New York Times, the Washington Post, USA Today, the Associated Press, Reuters, ABC, NBC, CNN and NPR—were invited to have their stories shaped. The day after the briefing, on February 4, everybody—except for the New York Times—ran with stories about the ad campaign. Independent comment was notably missing. Only NPR, which went live hours after the others, and CNN, in an update to its story midday, managed to get any reaction from anyone outside of the FDA. CBS plunked down an out-of-context quotation from the director of the Centers for Disease Control and Prevention, probably in hopes that readers wouldn't notice that it was two months old. Nobody else seems to have tried to get anyone who could critique the ad campaign.
The result was a set of stories almost uniformly cleaving to the FDA's party line, without a hint of a question about whether the ad campaign would be as ineffective as many other such campaigns. Not one of the media outlets said anything about the close-hold embargo. From the agency's point of view, it was mission accomplished.
The FDA had a much harder task two months later. The agency was about to make public controversial new rules about electronic cigarettes. It was nearly impossible to keep the story from leaking out ahead of time; days before the new rules were going to be published in April 2014, rumors were flying. Reporters around the country could smell the story and began to e-mail the FDA's press office with questions about the e-cigarette rules. The agency flacks would have to use all the powers at their disposal to control the flow of information.
“I've heard a number of rumors that the FDA will be releasing its proposed e-cigarette regulations on Monday,” Clara Ritger, then a reporter with the National Journal asked on Friday, April 18. “I wanted to see if I could confirm that? If that's not accurate, do you have a timeline?” Stephanie Yao, then an FDA press officer, dodged the question: “The proposal is still in draft form and under review. As a matter of policy, the FDA does not share draft rules with outside groups while a rule is still under review.”
The fencing match was on. “Thank you for following up with the statement,” Ritger responded. “While I know the proposal is still in draft form and under review, for my planning purposes I wanted to find out when the proposed regulations will be coming out?”
“Have you subscribed to FDA press announcements?” Jenny Haliski, then another FDA press officer, wrote back on Monday. “The proposed rule itself will be published in the Federal Register.”
“Thanks for sending! I signed up,” Ritger responded. “The only other question I had was when the proposed regulations would come out, off the record, for planning purposes?”
Not even an offer of being off the record could get the agency to spill the beans. “The FDA can't speculate on the timing of the proposed rule,” Haliski replied.
But this was a carefully crafted half-truth. There was no need to speculate. Haliski and others in the press office knew quite well not just that the rule was going to be published on Thursday, April 24, but also that there was going to be a close-hold embargoed briefing on Wednesday. It's just that Ritger and the National Journal weren't invited.
The invite list had been drafted days earlier, and, as usual, the briefing was limited to trusted journalists: the same outlets from the ad campaign briefing in February, with the addition of a few more, which included the Wall Street Journal, the Boston Globe, the Los Angeles Times, Bloomberg News, Politico and the Congressional Quarterly. At the very same moment that the agency was discussing the embargoed briefing with some of their chosen reporters, anyone outside that small circle, like Ritger, was being thrown off the trail. Not even Fox News was allowed in.
Some within the FDA press office wondered why Fox was excluded, unlike the other major networks. “BTW, we noticed that Fox still wasn't on the invite list,” Raquel Ortiz, then an FDA press officer, told Haliski.
“I have no national Fox reporter who had contacted me on this topic,” Haliski responded. “All reporters invited to the briefing needed to have covered tobacco regulatory issues before.”
Ortiz realized that this wasn't an honest answer: “But they definitely cover FDA/CTP [Center for Tobacco Products] and tobacco stories—[a colleague has] seen them.”
“We don't have a good contact for Fox,” Haliski insisted, rather lamely. A contact would not have been hard to find had they bothered to look. And, as chance would have it, the contact found them. Early the next morning, with plenty of time before the briefing, Fox's senior national correspondent—John Roberts, one-time heir apparent to Dan Rather—contacted Haliski asking for access. “I'm aware that the FDA will likely come out with its deeming rule regarding e-cigarettes in the next week or so. I'd like to have a story ready to go for the day (holding to any embargo),” he wrote. “Can we make that happen?”
“Hi, John, Have you subscribed to FDA press announcements?” Access denied.
“I was particularly troubled by it because I was the medical correspondent for CBS Evening News for a couple of years, and I had a very good relationship with the FDA and everybody there,” says Roberts, who found out he was excluded after the other correspondents' stories came out. “I was told by these folks that Fox news wasn't invited because of ‘past experiences with Fox.’”
A little after noon on Wednesday, April 23, the briefing went on as scheduled. All the reporters present understood the terms, as announced: “As discussed, under this embargo you will not be able to reach out to third parties for comment on this announcement. We are providing you with a preview of the information with this understanding.” But by 2:30 P.M., the close-hold embargo was already fraying at the edges. FDA officials apparently got wind that a reporter was trying to talk to a member of Congress about the new rules. Even though it was not clear that this was a breach of the embargo—the interview was scheduled for after the embargo expired, and the reporter presumably did not share any crucial information ahead of time—it was bending the close-hold rules, and the FDA was livid. Within half an hour, FDA's Erica V. Jefferson had fired off an angry e-mail to the close-hold journalists.
“It has been brought to our attention that there has already been a break in the embargo…. Third-party outreach of any kind was and is not permitted for this announcement. Everyone who participated agreed to this,” she wrote. “Moving forward, we will no longer consider embargoed briefings for news media if reporters are not willing to abide by the terms an embargo…. We take this matter very seriously, and as a consequence any individuals who violated the embargo will be excluded from future embargoed briefings with the agency.” Violate the rules, even in spirit, and you'll be left out in the cold with the rest.
The denials flew in. “This is very frustrating as someone who has consistently played by the rules and has covered CTP/FDA for years to be lumped in with a group of reporters that cannot respect your requests not to reach out to third parties,” insisted then AP reporter Michael Felberbaum. “I have of course always advocated that you work more closely with reporters like myself who clearly understand and cover this area consistently instead of reporters who are just assigned to handle on a whim.”
But despite the scare about a breach, the secrecy held. When the embargo expired and the early news stories went online, the FDA had little to complain about; the embargo had worked once again to shape coverage. Felberbaum's piece, for example, quoted Margaret Hamburg, then head of the FDA, and Mitch Zeller, the head of the agency's CTP, but nobody else. Even after he updated his piece later in the day to get some outside comments, there was little hint of how controversial the new rules were. Members of the tobacco industry were generally unhappy with increased federal regulation of their business, while antitobacco advocates tended to argue that the new regulations were far too weak and took way too long to promulgate. And there was no mention, in Felberbaum's article, at least, that the agency had tried to regulate e-cigarettes several years earlier but was slapped down with a stinging rebuke from the U.S. District Court for the District of Columbia. (When asked about his work for the AP, Felberbaum—who has since quit his job as a reporter to become an FDA press officer—said, “I'm not really sure whether I'm comfortable discussing that at this point.”)
Some of the other outlets, like NPR, injected a little more nuance into their pieces, despite the restrictions, by doing additional reporting after the embargo expired. (In a statement, NPR said that agreeing to the FDA's conditions was not a violation of ethics guidelines and “in no way influenced which other voices or ideas were included in the coverage.”) Still, even those pieces did not stray far from the key messages that the agency wanted to get across. Again the FDA found little to complain about. Except for one little thing.
Of all the media outlets, the New York Times was the only one to mention the close-hold embargo: “FDA officials gave journalists an outline of the new rules on Wednesday but required that they not talk to industry or public health groups until after Thursday's formal release of the document.” (“I felt like I wanted to be clear with readers,” Sabrina Tavernise, the author of the story, later told Sullivan, the New York Times' public editor at the time. “Usually you would have reaction in a story like this, but in this case, there wasn't going to be any.”)
The FDA was not pleased that the omertà had been broken. “I have to say while I generally reserve my editorial comments, I was a little surprised by the tone of your article and the swipe you took at the embargo in the paper—when after combing through the coverage no one else felt the need to do so in quite that way,” the FDA's Jefferson upbraided Tavernise in an e-mail. “To be clear, this is me taking stuff personally when I know I shouldn't, but I thought we had a better working relationship than this…. I never expect totally positive coverage as our policies are controversial and complex, but at least more neutral and slightly less editorialized. Simply put, bummer. Off to deal with a pissed Fox News reporter.”
Tavernise promptly apologized. “Geez, sorry about the embargo thing. Editors were asking why we didn't get to see it so I was asked to put a line in to explain,” she wrote. (Tavernise declined to comment for this article; Celia Dugger, one of the New York Times editors who handled the piece, said via e-mail: “As to the decision to describe the conditions of the embargo in the story, Sabrina and I talked it over and agreed it was best to include them.”)
The FDA was not pleased that the secret of the close-hold embargo was out, and the excluded press was confused and angry. “In this particular instance, it struck me as very strange,” says Fox's Roberts. “It was a government agency picking and choosing who it was going to talk to on a matter of public policy, and then the fact that I had a longstanding relationship with the FDA that, with this new administration, didn't seem to matter.”
Oransky complained again on Embargo Watch about the FDA's attempts to turn journalists “into stenographers.” Sullivan asked a few pointed questions of Jefferson, who, in Sullivan's words, insisted that the FDA's intent was “not to be manipulative but to give reporters early access to a complicated news development” and noted, in passing, that Tavernise had not objected to the terms of the close-hold embargo. But the damage was short-lived. Very little came of the complaints; Sullivan said that she would “like to see the Times push back—hard—against such restrictions in every instance and be prepared to walk away from the story if need be,” but there is no evidence of any substantial pushback by anyone.
The two-tiered system of outsiders and insiders that undergirds the close-hold policy is also still enforced. Major press outlets such as Scientific American and Agence France-Presse have written to the FDA to complain about being excluded but have not received any satisfaction from the agency. Months after the e-cigarette affair and following a different FDA story about food labeling that insiders had early access to, Time magazine complained about its lack of access to a select-press-only phone call. “Time was not included … (they weren't even on my radar to be honest with you), but we handled all their queries” the day after the call, then FDA press officer Jennifer Corbett Dooren wrote.
Absent any indications from the agency, it is anyone's guess whether the close-hold embargo is still in use at the FDA and, if so, how frequently. Unfortunately, the FDA refused to answer any questions. Because I am suing the agency for access to documents about embargo practices at the FDA, the press office, in a statement that failed to answer any specific questions, said that news embargoes “allow reporters time to develop their articles on complex matters in an informed, accurate way” and that its use of embargoes conforms to relevant government guidelines and best practices. The press office referred all questions to the FDA's Office of the Chief Counsel, which did not supply answers.
Since the New York Times slip, no journalist covering the agency has openly mentioned being subject to such restrictions. Scientific American made a significant effort to contact many of the reporters believed to have agreed to an FDA close-hold embargo—including the AP's Felberbaum, the Times' Tavernise, NPR's Stein, and other reporters from Reuters, USA Today and the LA Times. None could shed any light on the issue. Some explicitly refused to speak to Scientific American; some failed to return queries; two had no recollection of having ever agreed to a close-hold embargo, including Tom Burton, a Pulitzer Prize–winning Wall Street Journal reporter and the only one willing to answer questions. “I didn't remember it at all, and [even] after you told me, I didn't remember,” he said. As far as he knows, Burton added, such embargoes are rare.
No matter how rare it might be, there is documentary evidence of its happening multiple times, and each instance since 2011 is a violation of the FDA's official media policy, which explicitly bans close-hold embargoes. This policy still stands, just as it did before the last close-hold embargo. The smart money says that the agency's unofficial policy still stands, too—and the favoritism and close-hold embargoes continue. It is apparently too sweet an arrangement for the FDA simply to walk away.
Despite the difficulty of measuring the use of close-hold embargoes, Oransky and Kiernan and other embargo observers agree that they—and other variations of the embargo used to tighten control over the press—appear to be on the rise. And they have been cropping up in other fields of journalism, such as business journalism as well. “More and more sources, including government sources but also corporate sources, are interested in controlling the message, and this is one of the ways they're trying to do it,” says the New York Times' Sullivan. “I think it should be resisted.”
As much blame as government and other institutions bear for attempting to control the press through such means, the primary responsibility lies with the journalists themselves. Even a close-hold embargo wouldn't constrain a reporter without the reporter's consent; the reporter can simply wait until the embargo expires and speak to outside sources, albeit at the cost of filing the story a little bit later.
Says Oransky: “We as journalists need to look inward a little bit and think about why all of us feel we absolutely have to publish something at embargo [expiration] when we don't think we have the whole story?” Alas, Kiernan says, there isn't any movement within the journalism community to change things: “I don't know that journalists in general have taken a step back, [looking] from the 50,000-foot view to understand how their work is controlled and shaped by the embargo system.

This article was originally published with the title "How to Spin the Science News"

Saturday, September 17, 2016

Toxic Levaquin, FDA failure, Guns and the 2016 Election

Campaign 2016: Toxic side effects

by Dan Walter
Forget about guns… according to a long-time nemesis and drug safety activists, chances are that the Secret Service should be protecting Hillary Clinton from her doctor.
Among those who panicked at the recent sight of Hillary Clinton being physically helped toward the finish line in this election, supporters in the patient safety community suffered an extra jolt with the news that Clinton is being administered the antibiotic Levaquin to treat her pneumonia. The widely prescribed drug, along with other drugs like Cipro in the class known as fluoroquinolones, has been associated with an outsized risk of particularly nasty side effects — and should Hillary find herself among the minority of those who are injured by the drug, one of her main antagonists says the Democratic nominee for president may have herself partly to blame.
The Food and Drug Administration sent out an advisory in May of this year telling physicians what a lot of people already know about the class of drugs called fluoroquinolones: They can they be very dangerous. The problem seems to be that many doctors may not have gotten the memo.
“In my experience,” says patient safety advocate Linda Radach, “it is not uncommon for physicians to not know what the FDA has said or done. The chances are very high that Clinton’s physician has no idea that the FDA has posted black box warnings for the broad spectrum antibiotic. In general, unless there is someone within the provider network assigned to keep watch for FDA urgent postings, most physicians remain clueless of these warnings.”
“No matter how important a doctor is or how trusted, they are never fully informed about everything,” says Kathy Day, a retired nurse and safety advocate from Maine.
That has been my experience as well. I consider my current doctor to be the best primary care physician I have ever been to, but when it came time to treat bronchitis, he prescribed a fluoroquinolone. When I told him about the many people injured by the drug, the survivor support groups, the lawsuitsand the FDA advisories, he was genuinely surprised. He has been prescribing the drugs with great efficacy and no serious side effects for many years. In light of current knowledge about how these drugs can have crippling side effects in a small percentage of patients, one can assume that the doctor and his patients have simply been fortunate, although another possibility is that any injuries were latent and were not perceived to have been the result of the antibiotic.
But the fact that this very skilled and otherwise knowledgeable physician was unaware of the risks illustrates the information overload problem confronting doctors.
Rachel Brummert was prescribed fluoroquinolone for a sinus infection in 2006, and today she endures the suffering from the many bad reactions which began shortly after she took it, including nine tendon ruptures, peripheral neuropathy, arrhythmia, tremors, vertigo, tinnitus, persistent gastric problems and more.
She is now Executive Director of the Quinolone Vigilance Foundation and works to raise awareness of Fluoroquinolone Toxicity — among doctors.
“Whether Hillary Clinton should be prescribed Levaquin is obviously a matter for her to discuss with her doctor,” Brummert says. “One would assume that it is entirely appropriate. But for me, the point is that not all doctors have the information they should be getting from the FDA.”
Brummert says that the FDA should have been sending out “Dear Doctor” letters to increase the chances of informing physicians that these very powerful and effective antibiotics should be wielded with care. She sees current news coverage as an opportunity. “This highlights a bigger problem that needs to be addressed,” she says. “And we are hopeful that Clinton’s being put on Levaquin will spark a national conversation about medication safety and the balance between risk vs benefit.
Brummert has been pushing for the FDA to send out “Dear Doctor” letters for many months. “While I know that not all doctors will read them and their time is valuable, it’s better than whatever system is not working right now,” she says.
In the face of the FDA’s inaction, Brummert has taken the task upon herself through her foundation and expects to begin sending letters out by the end of the month.
Meanwhile, professional Clinton nemesis Larry Klayman probably could not believe his astonishing good luck when he heard the news that Hillary was being treated with Levaquin. Klayman’s the man who keeps the Clinton email controversy fully stoked through Judicial Watch, his “non-partisan educational foundation,” and with the antibiotic story, he has hit the triple jackpot in his Javert-like quest to take Hillary down a peg or two, having recently filed an $800 million lawsuit on behalf of five Levaquin victims.
In conjunction with the suit against Johnson & Johnson, the purveyors of Levaquin, Klayman initiated a RICO lawsuit charging former FDA commissioner Margaret Hamburg and her husband, hedge fund executive Peter Brown, with “collusion, conspiracy and racketeering alongside the pharmaceutical giant, Johnson & Johnson to conceal those deadly risks — to protect their financial stake.”
And here’s the kicker: Klayman says Hamburg got her job at the FDA because she and her husband contributed heavily to Hillary’s campaign, and to the Clinton Foundation, and that they “gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.” In short, the suit alleges, “Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation.”
The icing on the cake for Klayman is that one of the side effects of Levaquin plays right into Trumpian conspiracy theories regarding the health of the Democratic nominee. He plays the magnificent cards he’s been dealt expertly, as demonstrated by the headline for a recent press releaseproclaiming that “Hillary Clinton’s medical condition may be result of her taking dangerous drug Levaquin.”
Thus, Hillary’s everyday “medical condition” is transformed from pneumonia into one with far more profound political implications in Klayman’s release:
Under the heading “Central Nervous System Effects” on the Levaquin label, it states: “Fluoroquinolones, including Levaquin, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, toxic psychoses, increased intracranial pressure…. Fluoroquinolones may also cause… tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose….”
And now Fluoroquinolone toxicity has been added to the already poisonous brew of the 2016 presidential election.

Thursday, September 1, 2016

Surgical mesh survey shows 'horrific' patient outcomes.

Wednesday 31 Aug 2016 3:03 p.m.
The severe after effects of surgical mesh implants have been quantified for the first time in a survey, which suggests many problems could go unreported.
Lobby group Mesh Down Under is pushing for change in the way surgeons use the product and is raising awareness for the problems it can cause.
Fifty-seven of the group's 197 members responded to the survey, in which 87 percent said they weren't warned about the potential risks and 91 percent weren't offered an alternative treatment.
The mesh is used in a number of surgeries, including for pelvic organ prolapse and stress urinary incontinence.
The survey's results appear contrary to Medsafe's advice to DHBs and private hospitals last year, which said clinicians should consider research and talk to patients about treatment options, including the risks and benefits "in clear and simple terms".
Mesh Down Under survey results:
  • 70 percent experienced painful sex since surgery
  • 20 percent of cases reported to Medsafe
  • 80 percent needed one or more follow-up surgeries
  • 44 percent had their condition return after surgery
  • Of those who reported complications, 75 percent said GP didn't know about the adverse effects
Group spokesperson and registered nurse Patricia Sullivan said Medsafe had touted the benefits of mesh outweighing the risks.
"The risks are so horrific, that if people knew the risks, really knew how life-changing they are, they wouldn't do it.
"When it goes bad, it goes really bad," she says.
Problems with the mesh can sometimes take years to be felt, with 45 percent of respondents saying they'd had complications between five and nine years after surgery.
Ms Sullivan, who had an implant in 2008, says that makes it difficult for medical professionals to diagnose, with surgeons reluctant to re-operate.
"It took me four years for it to be diagnosed, and in those four years I saw six different specialists."
Ms Sullivan says the implants are faulty products, and pointed to three US states - Kentucky, Washington and California - suing Johnson & Johnson after they allegedly "concealed and misrepresented" the risk of surgical mesh.
Last week, the Government said it would consider creating a registry for the use of surgical mesh along with other recommendations from the health select committee.
The committee recommended:
  • Investigate options for establishing a centralised mesh registry, consistent with international recording of mesh complications;
  • Review best practice around informed consent for surgical mesh patients;
  • Encourage health providers to ensure coding information is consistent so that patients with mesh complications can be identified and monitored;
  • Encourage utilisation of the adverse events reporting system;
  • Endorse ongoing education for surgeons around the use of mesh and mesh removal;
  • Consider expanding Medsafe's role to assess quality and safety of medical devices.
Fellow campaigners Charlotte Korte and Carmel Berry say the recommendations don't go far enough and backed Labour health spokesperson Annette King's call for a full inquiry.
New Zealand First health spokesperson Barbara Stewart says the survey's numbers are concerning and congratulated those who had been "working tirelessly" on the issue.
She urged the Government to adopt all of the committee's recommendations.
"New Zealanders have suffered for long enough. The Government must show leadership," she says.
ACC Minister Nikki Kaye says cost of surgical mesh claims in the 10 years to May 2015 was $7,752,000.
Ms Sullivan says the survey could be considered a pilot study into the effects of surgical mesh because data hasn't been collected by other authorities, including Medsafe.

Wellington, NZ

Wednesday, August 3, 2016

Medtronic $8.45M 'settlements' to two harmed patients: deny any wrongdoing!

Patients who received Medtronic product to get $8.45 million in settlements

By Jim Spencer Star Tribune AUGUST 2, 2016 — 10:22AM

Two patients who were injured by Medtronic’s controversial Infuse bone graft product will receive a combined $8.45 million in settlements with the University of California Los Angeles, where a doctor with financial ties to the company used the product on them.
Patients Ralph Weiss and Jerome Lew alleged that hundreds of thousands of dollars in Medtronic consulting, grants and royalty payments to UCLA surgeon Jeffrey Wang created conflicts of interest that led to risky treatments about which they were not informed. They said they were not told that they were receiving Infuse or that it was being inserted into mechanical devices with which it had never been tested for safety.
Claims of injuries from such “off-label” use have plagued Infuse almost from the time of its introduction into the market in 2002, and the company’s possible role in promoting those treatments has sparked government investigations and lawsuits. Studies have shown that the bone growth product is used 85 percent of the time in ways the FDA did not specifically approve.
Medtronic denied any wrongdoing in the Weiss or Lew cases. The company settled with Lew for an additional amount of money that it declined to reveal.
“Medtronic’s company policies and extensive training expressly provide that we promote our products only for those uses that are consistent with the labeling approved by the FDA,” a spokesman said in a statement.

Both Weiss and Lew ended up with unwanted bone growth in their spines that caused nerve damage. Weiss got $4.25 million from UCLA, while Lew got $4.2 million and settled separately with Medtronic for an additional undisclosed amount.

Weiss had lumbar spine surgery. Lew’s spine surgery involved placement of Infuse in his neck, where the FDA had warned it could cause nerve and breathing problems.
In addition to allegations of improper use of Infuse, Lew’s suit said Medtronic illegally misbranded the cage device that Wang implanted in Lew’s neck to hold the synthetic bone growth product. Lew’s suit alleged that Medtronic got the U.S. Food and Drug Administration (FDA) to approve the device without testing by saying it would be used in the chest and lower spine, but that Medtronic designed the device so that it was too small and the wrong shape to fit anywhere but the neck.
Records in the Lew case show that one of the device’s designers testified that he intended it to be used in the neck. Lew’s lawyers also found an e-mail from a Medtronic employee to UCLA officials noting that “because of its small size many surgeons prefer to use it in the cervical spine.”
Lew’s principal attorney, Robert Vaage, told Los Angeles Superior Court Judge Terry Green that he could find no examples of the cage being used anywhere except the neck.

Medtronic said decisions on which devices to use rested with the physician and the patient. “The upper vertebrae in the thoracic spine can be quite small so the system comes in a variety of sizes to accommodate the unique anatomies of different sized patients,” the company said in its statement.
The company said that Wang was not paid for using the Medtronic products used in Lew’s surgery, and that as of the time of the surgery involving Lew he was not a consultant for Medtronic.
UCLA did not respond to the specific allegations of the suits but said it settled so the school and its medical system “could move forward with their ongoing commitment to excellence in patient care, research, education and community service.”
Wang’s lawyer did not respond to a request for comment. Records show that Medtronic paid Wang nearly $300,000 in grants, royalties and consulting fees from 2000-2009. Wang’s image and quotes remain on Medtronic’s neck pain website. He is now chief of the orthopedic spine service at the University of Southern California medical school.
Medtronic has already written-off $140 million to pay for “probable and reasonably estimated damages” in Infuse cases, as well as $90 million to settle a shareholder Infuse suit. In October, the company faces a leadoff trial among hundreds of lawsuits filed by Infuse recipients who say the product injured them.

Weiss’ and Lew’s individual awards are large in comparison to other announced Infuse settlements, which have averaged less than $30,000 per patient.
Weiss’ case was strictly about an unapproved use of Infuse in Weiss’ lower spine, said Vaage, who represented both Weiss and Lew. Medtronic was dropped from the suit as a defendant because Wang admitted he knew the risks of Infuse, Vaage said.
Doctors are allowed to use medical devices in non-FDA-approved ways if they think it will help their patients. But federal law says device makers are not supposed to promote those uses.
Lew’s suit is among the first — if not the first — to successfully raise the issue of misbranded spinal cages for off-label uses of Infuse. Vaage said the case settled for a “confidential amount” after he interviewed current and former Medtronic employees, including Dr. Zafar Khan, one of the designers of the cage that went into Lew’s neck.
Khan testified under oath that the cage was designed and intended for use in the cervical spine, Vaage said. Vaage also unearthed correspondence that he says showed that Medtronic marketed the device for use in the neck despite the fact that the company told the FDA it was not supposed to be used there. Medtronic produced a “surgical technique guide” that showed the cage being used in the neck, Vaage said.

“We took the position that but for this cage being made available, Infuse would never have been used in Jeremy Lew’s neck,” and he never would have been injured, Vaage said.
The law does not require doctors to disclose to patients if they are receiving off-label treatments. But patient advocates say cases like Weiss’ and Lew’s show why public policy should pay more attention to informed consent.
Patients “assume that if the doctor says do it, that it’s been approved and tested and all of those things,” said Lisa McGiffert of Consumer Union’s Safe Patient Project. “There’s a lot of off-label use and patients don’t really understand that.”

Staff writer Joe Carlson contributed to this report.

Wednesday, June 22, 2016

FDA/CDRH - Celebrates 40 year old (unsafe and ineffective) Medical Device Amendments

Posted on June 22, 2016 by FDA Voice

By: Jeffrey Shuren, M.D., J.D.
In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”

Jeffrey Shuren, M.D., J.D., FDA’s Director of the Center for Devices and Radiological Health, speaking at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments
Unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.
Although Congress had first given FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, the focus was on fraudulent products. Efforts to extend FDA’s oversight on medical devices failed in 1962 and again in 1970.
Then in 1975, reports emerged that thousands of women had been harmed, some even died, from pelvic inflammatory disease, as the result of using the Dalkon Shield, an intrauterine device for contraception. Congress responded the following year by enacting the Medical Device Amendments, which authorized FDA to classify all medical devices based on risk into one of three classifications, to require premarket approval for Class III devices, and for devices to comply with reporting and GMP requirements.
The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since.
In signing the legislation, President Ford noted that, when “well designed and well-made and properly used” medical devices “support and lengthen life.” But when medical devices are “poorly designed, poorly made, and improperly used” they can “threaten and impair” life.” His words still ring true today.
The initial Medical Device Program started with about 180 people. Today, FDA’s Center for Devices and Radiological Health (CDRH) is 1,700 strong; a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement.
And the mom and pop industry has transformed into a world of sophisticated software algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence.
Along the way, CDRH has adapted its expertise and regulatory approaches to meet the needs of such rapidly evolving innovation. While we will continue to adapt, more importantly, we are focusing on proactively anticipating where we need to be so that regulatory innovation is out in front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle rather than applying a one-size-fits-all approach.
We are implementing new models for evidence generation. They include the establishment of a National Evaluation System for health Technology, or NEST, that could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices. This is consistent with our vision: That patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.
And we are also going to new places with patients by establishing a foundation for engaging with them as our partners and routinely incorporating their perspectives in our decisions. And that’s fitting because improving the health and the quality of life of patients by assuring they have timely access to medical technologies that will benefit them is at the heart of who we are and what we do.
As we look ahead to the future, it is our work, our care and our dedication that will allow us to reach our vision.
Jeffrey Shuren, M.D., J.D., is FDA’s Director of the Center for Devices and Radiological Health
Remarks at FDA’s Celebration of the 40th Anniversary of the Medical Device Amendments

Remarks of Jeffrey Shuren, M.D., J.D.
Director of the Center for Devices and Radiological Health
U.S. Food and Drug Administration
June 22, 2016

Anyone thought about where they were or what they were doing in 1976?
I was in junior high school with no clue what the FDA was but very focused on a girl I had a crush on.
In 1976, Nadia Comaneci won 3 gold medals in gymnastics in Montreal.
The Steelers won the Super Bowl.
Steve Jobs and Steve Wozniak founded Apple.
The first “punk rock” single—by a group called The Damned—flopped horribly.
A gallon of gas was $.59 and the Dow Jones Industrial Average closed the year at 1004.
And, as we know and are here today to celebrate, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA’s “horse and buggy authority” and “laser age problems.”
How we got here has been quite a journey. We’ve been using medical devices for thousands of years, including tools to punch holes in the skull to let out evil spirits and sticks to help the disabled walk. In 1850, a German scientist, Hermann von Helmholz, invented one of the first modern day medical devices, the ophthalmoscope, using a light source and lenses to view the interior of the eye.
At about the same time, Willhelm Roentgen, a professor of physics in Bavaria, discovered that radiation can penetrate solid objects of low density, which led to the invention of X-ray machines. In 1927, the respirator was introduced. In 1939, the first heart-lung bypass machine came on the market.
However, unlike the pharmaceutical industry, which was born from large chemical companies that discovered medical uses for the products they made, the device industry sprung to life as a scrappy sibling—mostly mom-and-pop businesses addressing the needs of individual patients and physicians through invention.
I’ll give you an example: Earl Bakken and his brother-in-law Palmer Hermundslie co-founded Medtronic in 1949 in a garage in Minneapolis. The company started as a repair service for hospital electrical equipment and a regional distributor for other manufacturers. They would build new equipment on order or customize standard instruments for laboratory or clinical researchers. They would install equipment, train personnel on their use, troubleshoot and repair it as necessary. At the time, they were barely getting by.
Enter Walton Lillehei. This world-renowned cardiac surgeon at the University of Minnesota pioneered techniques for the repair of congenital defects as part of the rapidly evolving field of open heart surgery.
Despite successful repair of the congenital defect, about 1 patient in 10 developed post-operative, complete heart block due to damage of the conducting system while the surgical repair was being performed. It was thought that temporary cardiac rhythm support via pacing would keep the patient alive until recovery of the conducting system occurred. However, the high voltage pacing stimuli delivered across the chest by the machine invented by Zoll was believed to be too traumatic on young children.
Dr. Lillehei and his co-workers developed the myocardial wire – a multi-stranded, braided stainless steel wire in a Teflon sleeve that could deliver low voltage pulses. One end of this wire was implanted directly into the heart muscle and the other end was connected outside the body to the physiology lab stimulator.
Early attempts to use the device were successful until October 31, 1957,  when a 3-hour municipal power failure resulted in the tragic death of a baby. The hospital had emergency power generation in its surgical suites and recovery area but not in its patient rooms.
The very next day, Lillehei asked Bakken to see if Medtronic could come up with something better.
Initial attempts at building a more reliable and portable pacemaker involved adding an automobile battery with an inverter to convert 6 volts direct current into 115 volts alternating current.
This didn’t work. So, Bakken found a back issue of Popular Electronics where he had seen a circuit for an electronic, transistorized metronome. He modified the two-transistor circuit and placed it, without the loudspeaker, into a four-inch-square and inch-and-a-half-thick aluminum box with terminals and switches on the outside. The circuit was run by a miniature 9.4 volt battery housed within the box.
From that determination and ingenuity sprung the field of “medical electronics.” Prior to 1957, there had never been a partly or completely implantable electrical device.
Every journey brings new inspiration and experience—and, inevitably, bumps, potholes, and dead ends.
Following Medtronic’s early success, the pace of innovation picked up dramatically. But, the transition from garage to manufacturing facility didn’t always include rigorous scientific and clinical evaluation. Instead, it continued to rely on bedside observation for benefit and risk determinations.
Which led to problems. And tragedy.
Congress first gave the FDA explicit authority over medical devices in the 1938 Food, Drug, and Cosmetic Act, with our focus primarily on fraudulent products. However, in 1962 when Congress passed a new regulatory framework for drugs, they dropped President Kennedy’s proposal to include medical devices.
Then in 1970, President Nixon established the Cooper Committee – chaired by Dr. Theodore Cooper, then director of the National Heart and Lung Institute – to study medical devices as part of the President’s endorsement of medical device legislation. The committee recommended that any new legislation be specifically targeted to the device industry, because devices presented entirely different issues from drugs. It also suggested that different classifications for medical devices be created, which would tailor the regulatory controls to the risks involved. But Congress couldn’t agree on a bill.
In 1975, reports emerged that thousands of women had been harmed, some even died, from pelvic inflammatory disease, as the result of using the Dalkon Shield, an intrauterine device for contraception. Congress responded by enacting the Medical Device Amendments, which authorized the FDA to classify all medical devices based on risk into one of three classifications, to require premarket approval for Class III devices, and for devices to comply with reporting and GMP requirements.
The law ushered in a new era for medical technology innovation, patient access, and patient safety, but also created a tension, contributing to a political environment where the pendulum continues to swing between these objectives, defining and driving the medical device ecosystem ever since.
“Today, devices are routinely implanted in our bodies. They replace limbs, bones, tissues, even entire organs. They permit treatment of forms of illness that can be accomplished in no other way. They magnify and speed 10 thousandfold the diagnostic power of the human eye and brain.
“Medical and diagnostic devices have produced a therapeutic revolution, but in doing so they have also become more complex and less easily understood by those who use them. When well designed, well made, and properly used they support and lengthen life. If poorly designed, poorly made, and improperly used they can threaten and impair it.”
While I’d like to take credit for those words—I can’t. While they sound suspiciously recent—they are not.
These are President Gerald Ford’s words—a succinctly accurate and descriptive summary of why, in 1976, America desperately needed the law he was signing to allow the FDA to regulate medical devices based on risk.
Medical devices can save and give us better lives. I know because my family has relied on them for years – from cardiac stents to implantable hips to the mammogram that picked up my wife’s cancer in time to get her the treatment she needed. But we can rely on these medical miracles because of the careful oversight we provide here at CDRH.
When my wife had to decide what course of treatment to pursue, she was given the results of a laboratory developed test. However, it wasn’t until she and I had the results from an FDA-approved test that we had the information and the confidence we needed to make fully informed decisions.
It is our work, our care, and our dedication that will allow us to reach our vision—that patients in the U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world.
CDRH’s vision—our shared vision – intentionally begins with “patients” because improving the health and the quality of life of patients by assuring they have  timely access to medical technologies that will benefit them is at the  heart of who we are and  what we do.
After 40 years, we live in a world of sophisticated software algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence. And, all along the way, we at CDRH have had to adapt our expertise and regulatory approaches to meet the needs of rapidly evolving innovation. That has been our history.
Make no mistake:  We are as scrappy and as enterprising as the industry we regulate.
As we look to the future, however, we will continue to adapt, but, more importantly, we will and have already begun to focus on proactively anticipating where we need to be so that regulatory innovation can get out in front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle needs rather than applying a one-size-fits-all approach.
 And we are implementing new models for evidence generation, such as through the establishment of a National Evaluation System for health Technology, or NEST, that could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices.
We are going to new places with the patients who drive our mission, by establishing a foundation for routinely incorporating their perspectives in our decisions. After all, they are our most important customer and should be our partner in best serving them.
Forty years ago, the initial Medical Device Program started with about 180 people, and our country was celebrating its 200th anniversary. That year, NASA unveiled its first space shuttle – The Enterprise – which, as a Star Trek fan, I thought was very, very cool. As a nation we were ready to soar.
Forty years later, CDRH is 1,700 strong; a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement, including what one day soon may be the first Star Trek-like tricorder. While our mission and vision guide us, and patients drive us—it is our people and their diverse personal and professional backgrounds, experiences, and expertise who are fundamental to our success as a public health agency.
If our mission and vision are our North Star, if patients are our compass, then our ship – our USS Enterprise – that will boldly go where no person has gone before – is CDRH, and you are its crew.
Captain James T. Kirk once said, “You know the greatest danger facing us is ourselves, an irrational fear of the unknown. But there’s no such thing as the unknown — only things temporarily hidden, temporarily not understood.”
I don’t know what new worlds we will discover or the new technologies we will encounter, but I look forward to traveling there with you wherever we may go.

Happy anniversary.