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.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label New York Times. Show all posts
Showing posts with label New York Times. Show all posts

Tuesday, November 22, 2016

Bayer Essure: Failure to Inform Patients of Harm or to Follow Patient Outcomes

Bayer’s Essure Contraceptive Implant, Now With a Warning

By RONI CARYN RABIN            NOVEMBER 21, 201

Kim Myers used to compete in rodeo-style barrel horse races, but after being sterilized with an implantable device called Essure, the pain was so intense that she had to stop.
The device’s small metal and polyester coils had pierced her fallopian tubes, her doctor found, so the two implants were removed. But the sharp, laborlike pains didn’t really subside until three years later, when Ms. Myers had a hysterectomy.
Then her surgeon discovered the cause: A piece of metal coil was still embedded in her uterus.

Kim Myers, 53, in the stable at her home in Wesson, Miss. Even after her two Essure implants were surgically removed, her sharp pains didn’t subside until she had a hysterectomy.
EDMUND D. FOUNTAIN FOR THE NEW YORK TIMES
“Doctors kept saying there was nothing wrong with me,” said Ms. Myers, 53, of Wesson, Miss. “I knew, with every fiber of my being, there was still something there.”
Ms. Myers was among a parade of women who testified before the Food and Drug Administration 14 months ago, saying they’d been injured by Essure and urging officials to pull the device from the market.
Essure comprises two small coils, made of a nickel alloy and a polyesterlike fiber, placed in the fallopian tubes through the vagina. The coils are designed to provoke an inflammatory response that causes scar tissue to form and block the tubes, a process that can take three months.
F.D.A. officials declined to withdraw the device, saying that Essure was safe and effective for many women although some experienced “very serious and sometimes debilitating problems.” But last week the agency ordered that a so-called black box warning be placed on the device’s packaging saying it could cause the kinds of injuries Ms. Myers sustained.
The implant may puncture the fallopian tubes and uterus, and travel into the abdomen and pelvic cavity, the warning notes, causing persistent pain and requiring surgical removal.

Officials at Bayer, which makes and sells Essure, say poor surgical skills are to blame for complications like Ms. Myers’s and insist there is no proof the device causes other reported side effects like chronic pain and autoimmune disorders.
“These are so common to women,” said Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs.


The F.D.A. also took the unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device. The three-page checklist is broken into five sections, each followed by a spot for the patient’s initials, and is to be signed by both doctor and patient.
The checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding.
Some doctors complain that the checklist is intrusive and burdensome, may dissuade physicians from using the implants, and is based on anecdotes rather than scientific clinical trial data. Some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.
“There’s no question there are complications, but there are risks and benefits to everything we do in medicine, and we don’t have good data to establish the magnitude of the problem,” said Dr. Christopher M. Zahn, the vice president of practice for the American College of Obstetricians and Gynecologists.
“Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” Dr. Zahn said, referring to the black box warning and the checklist.
Dr. Zampaglione of Bayer noted that some studies had shown that other methods of permanent sterilization, not just Essure, have caused serious long-term adverse events as well.
The F.D.A. approved the implant in 2002 after a fast-track review process that prioritized the device because it was the first sterilization procedure for women that could be done in a doctor’s office, without an incision and without general anesthesia. It offered an option to tubal ligation, commonly known as having one’s “tubes tied.”
Pain and other serious side effects emerged in the clinical trials of Essure. The device could not always be implanted, and failed to block the tubes in a significant percentage of patients. According to the new checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy.
The F.D.A. approved Essure after trials lasting a year or two, even though the implant was meant to last for life. By the end of last year, the agency had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities.
Many doctors who insert the implant do not know how to remove it.
By contrast, drug trials are required to have a comparison group of participants who are given a placebo.
Earlier this year, Bayer agreed to begin tracking 1,400 women who have the device implanted over the next five or six years. The study is supposed to report final results in 2023, but is already behind schedule.
This study has a comparison group of sorts: It will also follow 1,400 women who choose a more traditional form of sterilization using laparoscopic surgery.
The women will be followed for three years after the sterilization procedures to see how many in each group develop complications like chronic pelvic pain, heavy bleeding and autoimmune disorders, as well as how often each intervention fails, leading to pregnancy.

Researchers will also track how many women with Essure develop such severe complications that they have to undergo surgery to remove the implants.
http://mobile.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html?referer=https%3A%2F%2Fwww.google.com%2F

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"

Friday, May 29, 2015

Healthcare lobbyists outnumber Congress 5 to 1. Are the voters revolted yet?


Polluted Political Games

MAY 28, 2015  Nicholas Kristof                                                                                                                                       I’ve admired the Clintons’ foundation for years for its fine work on AIDS and global poverty, and I’ve moderated many panels at the annual Clinton Global Initiative. Yet with each revelation of failed disclosures or the appearance of a conflict of interest from speaking fees of $500,000 for the former president, I have wondered: What were they thinking?
But the problem is not precisely the Clintons. It’s our entire disgraceful money-based political system. Look around:
• Gov. Chris Christie of New Jersey accepted flights and playoff tickets from the Dallas Cowboys owner, Jerry Jones, who has business interests Christie can affect.
• Senator Marco Rubio of Florida has received financial assistance from a billionaire, Norman Braman, and has channeled public money to Braman’s causes.

When problems are this widespread, the problem is not crooked individuals but perverse incentives from a rotten structure.
“There is a systemic corruption here,” says Sheila Krumholz of the Center for Responsive Politics, which tracks campaign money. “It’s kind of baked in.”
Most politicians are good people. Then they discover that money is the only fuel that makes the system work and sometimes step into the bog themselves.
Money isn’t a new problem, of course. John F. Kennedy was accused of using his father’s wealth to buy elections. In response, he joked that he had received the following telegram from his dad: “Don’t buy another vote. I won’t pay for a landslide!”
Yet Robert Reich, Bill Clinton’s labor secretary and now chairman of the national governing board of Common Cause, a nonpartisan watchdog group, notes that inequality has hugely exacerbated the problem. Billionaires adopt presidential candidates as if they were prize racehorses. Yet for them, it’s only a hobby expense.
For example, Sheldon and Miriam Adelson donated $92 million to super PACs in the 2012 election cycle; as a share of their net worth, that was equivalent to $300 from the median American family. So a multibillionaire can influence a national election for the same sacrifice an average family bears in, say, a weekend driving getaway.
Money doesn’t always succeed, of course, and billionaires often end up wasting money on campaigns. According to The San Jose Mercury News, Meg Whitman spent $43 per vote in her failed campaign for governor of California in 2010, mostly from her own pocket. But Michael Bloomberg won his 2009 re-election campaign for mayor of New York City after, according to the New York Daily News, spending $185 of his own money per vote.
The real bargain is lobbying — and that’s why corporations spend 13 times as much lobbying as they do contributing to campaigns, by the calculations of Lee Drutman, author of a recent book on lobbying.
The health care industry hires about five times as many lobbyists as there are members of Congress. That’s a shrewd investment. Drug company lobbyists have prevented Medicare from getting bulk discounts, amounting to perhaps $50 billion a year in extra profits for the sector.

Likewise, lobbying has carved out the egregious carried interest tax loophole, allowing many financiers to pay vastly reduced tax rates. In that respect, money in politics both reflects inequality and amplifies it.
  • Lobbyists exert influence because they bring a potent combination of expertise and money to the game. They gain access, offer a well-informed take on obscure issues — and, for a member of Congress, you think twice before biting the hand that feeds you.
The Supreme Court is partly to blame for the present money game, for its misguided rulings that struck down limits in campaign spending by corporations and unions and the overall political donation cap for individuals.
Still, President Obama could take one step that would help: an executive order requiring federal contractors to disclose all political contributions.

COMMENTS
“President Obama could bring the dark money into the sunlight in time for the 2016 election,” notes Michael Waldman of the Brennan Center for Justice at the New York University School of Law. “It’s the single most tangible thing anyone could do to expose the dark money that is now polluting politics.”
I’ve covered corrupt regimes all over the world, and I find it ineffably sad to come home and behold institutionalized sleaze in the United States.

Reich told me that for meaningful change to arrive, “voters need to reach a point of revulsion.” Hey, folks, that time has come.

http://www.nytimes.com/2015/05/28/opinion/nicholas-kristof-polluted-political-games.html

Thursday, April 23, 2015

Stop Military and Civilian Medical Error 'Death Without Disclosure': Petition

Please sign this petition!  Disclosure:  Death from Medical Errors




WE PETITION THE OBAMA ADMINISTRATION TO:
Mandate Reporting of All Medical Errors to an Independent Oversight Committee, and to the Patient or Their Next of Kin.
We call on President Obama to mandate a national 'Medical Error Transparency Plan'. Medical errors are known to be the third leading cause of death, and medical errors also create a high number of disabilities. Patient's human rights are being violated by the current lack of transparency. We call for mandatory reporting of medical errors by anyone that has knowledge of, or reasonably suspects, that a medical error has occurred. Reporting must be to an independent oversight committee as well as to the patient, or to the deceased / incapacitated patient's healthcare representative.


Background story:  

Service Members Are Left in Dark on Health Errors

By SHARON LaFRANIERE APRIL 19, 2015
FORT WAYNE, Ind. — Lt. Col. Chad Gallagher was T. J. Moore’s squadron leader when the 19-year-old recruit arrived for basic training last spring at Lackland Air Force Base in San Antonio. He was watching at the quarter-mile track nine days later when Mr. Moore, on an easy mile-and-a-half test run, collapsed at the finish line and was rushed to a hospital.
And he was in Indiana shortly afterward to deliver a sorrowful eulogy at Mr. Moore’s funeral. “He had tears in his eyes,” Mr. Moore’s mother, Anita Holmes, said in an interview at her home here. “He said, ‘I didn’t do enough to protect T. J.’ ”
A year later, Ms. Holmes says she still does not know what Colonel Gallagher meant by that.
Outside experts who reviewed her son’s medical records at the request of The New York Times identified a serious medical error at the Lackland clinic: a decision to allow Mr. Moore to make the run even though doctors had pulled him from normal training after he failed the same test just days before. Test results revealing a genetic condition that in rare cases can lead to sudden death during physical exertion were apparently overlooked.

But the official Air Force explanation — in a 15-page report in a white binder, delivered to Ms. Holmes in December after months of inquiries — was that the military had followed proper protocol. No mistakes were identified. No one was faulted.
“I raised T. J. as a single mother on little income for 19 years, and kept him safe. They had him for nine days and sent him home to me in a box,” said Ms. Holmes, who called the report “garbage.”
“No one,” she added, “has really given me good answers about why.”
Tens of thousands of serious medical mistakes happen every year at American hospitals and clinics. While a handful of health care organizations have opted for broad disclosure amid calls for greater openness, most patients and their families still face significant obstacles if they try to find out what went wrong. But as Mr. Moore’s case illustrates, the nation’s 1.3 million active-duty service members are in a special bind, virtually powerless to hold accountable the health care system that treats them.
They are captives of the military medical system, unable, without specific approval, to get care elsewhere if they fear theirs is substandard or dangerous. Yet if they are harmed or die, they or their survivors have no legal right to challenge their care, and seek answers, by filing malpractice suits.
Only 18 months ago did the Pentagon explicitly allow them to file complaints about their treatment, although some had done so earlier. But even then they are barred from learning the results of any inquiry. Under federal law, investigations at military hospitals and clinics are confidential, in part to keep the findings from the roughly two million civilian patients they treat per year — spouses and children of service members, retirees and others — who can and do file malpractice claims.
In scores of interviews, active-duty patients, relatives and military medical workers described how, in that information vacuum, attempts to ferret out the truth about suspected medical mistakes — through freedom-of-information requests, complaints, meetings with military medical officials — produced anodyne letters of condolence, blanket denials of poor care or simply nothing at all.

“There is just no transparency. You can’t sue. You have no insight into the process,” said Cheryl Garner, a military intelligence officer who retired last year. “As active duty, we just don’t have much recourse.”
What’s more, until 2009, clinicians found to have delivered substandard care to active-duty patients in most cases were not reported to a national database that tracks problem medical workers; instead they were reported to an internal database. Even now, those clinicians, typically doctors, are mainly reported only if the service member is disabled or dies, a higher bar than in cases involving civilians.
And comparatively few have been reported, to either database, Pentagon records show. The Army, which runs the bulk of the system’s hospitals, treats four civilian inpatients for every active-duty one. But from 2003 to 2013, it reported nearly 50 times as many medical workers for breaching the standard of care in cases involving civilians.
The experiences of active-duty patients point to broader questions of accountability in a system of 54 hospitals and hundreds of clinics that has recently come under intense scrutiny. As The Times has reported, military hospitals often fail to conduct safety investigations that the Defense Department mandates when patients suffer serious harm or die. Many medical workers report reprisals for speaking out about problems with care. And systemwide efforts to limit errors and bolster quality have often foundered in a convoluted bureaucracy.
Amid growing fiscal pressures, the Defense Department has ordered improvements and is pushing to close hospitals where surgeons and other specialists treat too few patients to keep skills honed. In a new report to President Obama and Congress, a blue-ribbon commission argued that the military hospitals are wrongly modeled after typical civilian hospitals and so are stumbling in their central mission — to train a medical corps for injuries in combat zones.
In an interview, Dr. Jonathan Woodson, the Pentagon’s top health official since 2011, said that the federal confidentiality law notwithstanding, the military explicitly requires its clinicians and facilities to be open and accountable to all patients. If patients and the public once were unnecessarily denied information about quality of care, he said, “that went out the door when I came in.”
“From the top we are fully committed to the standard of transparency,” he said, describing efforts that include retraining thousands of doctors. If that message is not being heeded, he said, “we want to know.”
Yet military culture makes service members the least likely to complain, for fear of being branded troublemakers. And when they have spoken up, some said, they have been brushed aside.
Ms. Garner was 35 in 2007 when she saw a physician assistant at the Langley Air Force Base hospital three times for breast pain and other symptoms she feared might point to cancer. The physician assistant not only dismissed her fears as irrational, she said, but threatened to place a note in her file that could have damaged her career if she came back again.

Nine months later, Ms. Garner was able to switch her care to a Navy hospital. A doctor there speedily ordered a mammogram — and discovered Stage 2 invasive breast cancer. Her persistence, he told her, had saved her life. A double mastectomy and chemotherapy followed.
After she recovered in late 2009, Ms. Garner filed a complaint against the physician assistant, hoping, she said, to protect other patients. But while sympathetic, the hospital’s chief of medical services told her that she had not been mistreated. Not long afterward, the physician assistant was promoted.
‘Drive Families Crazy’

“When it is pretty clear that something occurred, and nobody is being honest with them, that will drive families crazy,” said Dr. Robert Truog, a professor of medical ethics at Harvard Medical School.
To Belinda and Ronald Robinson, that aptly describes the five years they have spent seeking an explanation for what happened to their 27-year-old son, Sgt. Ronald Robinson Jr., at the hospital now called San Antonio Military Medical Center. A gregarious computer technician with a blue Mustang and a love of barbecue, Sergeant Robinson enlisted in the Army at 19, hoping for a long military career like his father’s. But six years later, he was found to have a heart condition called atrial fibrillation, shared by several million Americans and characterized by an abnormal heart rhythm. Exercise sometimes left him disoriented, dizzy, even unable to speak.
Facing a possible lifetime of medication, he decided on an outpatient procedure in which an electrode on a catheter threaded into the heart burns away the problem tissue. Tens of thousands of such procedures are conducted annually in the United States, with an estimated death rate below one in 1,000.
In April 2010, Mrs. Robinson was waiting at the hospital for her son’s procedure to end when a surgeon burst in. “Something went terribly wrong,” he told her. Despite an all-out effort, Sergeant Robinson died within hours.
Two days later, she said, the cardiac electrophysiologist who performed the procedure, Dr. Robert Eckart, telephoned her and her husband. “He said, ‘I wish I could tell you what happened,’ ” Mrs. Robinson recalled in an interview at the family’s restaurant in Slidell, La. “I can never ever forget what he said: ‘It is just an unknown.’
In his notes, Dr. Eckart described the case as an “unexplained rapid death.”
Experts say his caution may have been appropriate. It often takes a thorough inquiry to figure out what happened. But with that one phone call, the Army’s effort to explain Sergeant Robinson’s death came to an end.
Hospital records obtained by The Times suggest the required patient-safety inquiry was never conducted. When the Robinsons asked about the results of an investigation, the Army sent duplicate sets of their son’s medical records. Their Freedom of Information Act requests were answered with a copy of the Army secretary’s condolence letter.
“If we knew the truth, we could deal with what happened,” Mrs. Robinson said. “I could forgive them.”

Two specialists who reviewed Sergeant Robinson’s medical records at The Times’s request called his death both rare and perplexing. But one of them — Dr. Hugh Calkins, director of cardiac arrhythmia services at Johns Hopkins Hospital — said it was not a total mystery. Because of some unknown factor, possibly an equipment malfunction, he said, the doctor inadvertently cauterized too close to two crucial pulmonary veins and the veins shut down, causing fatal hemorrhaging.
“The best people in this field have inadvertently burned inside the veins, and almost always you get away with it,” he said. He called the outcome “a tragic, freak complication,” adding, “I hope that they were straight with the family.”
Told of his comments, Mrs. Robinson fell silent. “No one ever told us that,” she said.
Dr. Eckart, now a civilian physician, said in an email that patient-privacy laws prohibited him from discussing the case. But he wrote, “Sometimes there can be a bad outcome, even if everything was done right.”
Beyond helping bring closure, experts say, honesty about medical errors makes it harder for hospitals to gloss over serious lapses in care.
The San Antonio hospital, the military’s largest, has had a perennial problem with surgical infection control. In 2011, when Mark Probus underwent spinal surgery there, the infection rate of surgical wounds was 77 percent higher than expected, given the mix of cases, according to a Pentagon-ordered comparison with civilian hospitals.
Mr. Probus, then 44, was no average patient: A lieutenant colonel, he worked at Army medical headquarters, assessing hospitals.
But when he nearly died from a surgical infection, requiring three more operations and months of follow-up care, he got no better answers about what had gone wrong than did the Robinsons. When he asked whether the mandatory safety investigation had been conducted, he said, hospital staff members did not respond.
Mr. Probus retired on medical grounds in 2013, utterly disillusioned, he said, by the system’s lack of accountability. “I had no faith whatsoever in what I was doing anymore,” he said.
Honesty With Patients

Defenders of the federal confidentiality law argue that without it, medical workers would not speak freely about mistakes for fear of provoking malpractice suits by the system’s civilian patients. But evidence from some civilian hospitals increasingly raises questions about that argument.
In 2001, the University of Michigan Health System, the state’s largest medical center, decided that officials would inform patients and apologize whenever they discovered a serious preventable error or lapse in care. Administrators say physicians and nurses have grown more open about mistakes — not less — even though, unlike their counterparts in military hospitals, they can be individually sued for malpractice. The hospital has followed its disclosures by negotiating compensation, resulting in lower malpractice costs.
That level of honesty with patients is still rare, but momentum is growing to make it standard. The National Quality Forum, a nonprofit organization whose safety recommendations are followed by hundreds of hospitals, said in 2009 that hospitals should acknowledge and explain preventable errors to patients and apologize.



Dr. Thomas Gallagher, director of the University of Washington’s research center for patient safety and quality of care, said hospital officials can summarize the results of investigations without disclosing so much that medical workers would be afraid to talk. At Johns Hopkins, physicians routinely tell patients not only what inquiries found, but what changes resulted, said Dr. Albert W. Wu, a physician there and a health policy professor.
The Pentagon has taken steps to open up: Three years ago, officials successfully pushed Congress to narrow the 1986 confidentiality law, suspecting it was being used to withhold not only judgments about care but medical facts.
Regulations now require that those facts be shared, thousands of doctors are being retrained and a small band of mediators has been hired to help. The military’s policies, Dr. Woodson says, are no different from those of most civilian hospitals.
Still, in the eyes of leaders in the field, like Richard C. Boothman, the Michigan health system’s clinical safety chief, such policies fall short. “If you can’t be honest about the conclusion, about whether what you did was right or wrong, whether it was reasonable or not reasonable, I don’t see how you can say you have a culture of full disclosure,” he said.
Arguing the need to maintain military discipline, the Defense Department has opposed a series of congressional attempts to modify a law that the Supreme Court ruled in 1950 bars active-duty service members or their survivors from filing malpractice claims. Officials insist that the prohibition in no way lessens the quality or scrutiny of care provided to service members.
But it has led to a bifurcated system of review that has produced proportionally fewer reports of medical workers for substandard care of active-duty patients than of civilian ones.
If the department determines that a medical worker breached medical standards in a civilian case that resulted in a malpractice payment, the worker must be reported to the National Practitioner Data Bank, which health care and licensing organizations routinely check to spot problem physicians and nurses. A similar inquiry is supposed to ensue when the Pentagon authorizes death or disability benefits for an active-duty patient — although until 2009, clinicians who were faulted in those cases were reported only to an internal database.
But in practice, few active-duty cases reach that level of scrutiny. Col. Kimberly Kesling, the Army’s chief of patient safety, said that is because service members are typically young, healthy and in need of only routine care.
Even so, service members make up one-fifth of inpatients and one-fourth of the maternity cases at military hospitals. Yet from 2003 to 2009, the military reported just 15 clinicians for substandard care of active-duty patients, while reporting 710 clinicians — 47 times as many — for unacceptable care of civilian patients leading to a payment.

In interviews, other current and former senior health officials attributed the discrepancy to several factors. For one, analysts who review disability cases typically do not focus on whether bad care is to blame. Indeed, at seven military hospitals visited by inspectors, staff members who handled disability claims did not even know they were expected to look for signs of malpractice, according to a 2007 department report.

“The disability system has never been structured to be a quality-of-care review,” said a senior Air Force official in charge of risk management. “It is fundamentally a disconnect.”
Beyond that, clinicians can be reported for substandard care of a civilian patient who wins a malpractice claim no matter the level of harm — not just if the patient is disabled or dies. Finally, service members are often reluctant to even file disability claims for fear of being declared unfit for duty, making their cases less likely to be investigated.
The gap has narrowed since 2009, when the military tightened regulations and started reporting active-duty cases to the national database. But it has not vanished: In the next four and a half years, 17 times as many medical workers were reported for poor care of civilians than of active-duty patients.
From 2003 to 2013, the Army reported not a single clinician for breaching medical standards in a case that left a service member disabled — despite tens of millions of active-duty patient visits and roughly 250,000 hospitalizations.
‘A Terrible Error’
T. J. Moore enlisted in the Air Force two months after high school, telling his mother that he wanted to accomplish “something big” and help care for her and his sisters. “Now you can rest,” he told her.

A former football player with an engaging grin, he seemed to fit in well at the Air Force base in San Antonio. But on his first Saturday of basic training, he flamed out on the 1.5-mile run, part of a mandatory initial fitness test. Given 18 and a half minutes to run six laps, Mr. Moore stopped after three laps. “Running is not for me,” he declared.
The Times pieced together what followed from Mr. Moore’s medical records, the official Air Force report and records of the family’s meeting with Air Force officials.
Dr. Aasif Mirza, who examined Mr. Moore the next Tuesday at the base’s health clinic, pulled him from standard training. Neither alternative he proposed was viable under military regulations, so the next day, another physician, Dr. Charlie Collenborne, sent Mr. Moore to a medical hold unit for trainees with health issues.
A nurse wrote in his chart: “Pt reports that he can not run at all.” The official Air Force report said “a thorough medical evaluation” was ordered.
Had that occurred, someone most likely would have noticed the results of a blood test that had arrived at the clinic the previous afternoon. Routine lab work done when he arrived at Lackland showed that Mr. Moore had sickle-cell trait, a genetic condition affecting 8 percent of African-Americans.
The vast majority of people with sickle-cell trait lead normal lives, and many are not even aware of their status. But in rare cases, people with the trait who engage in sudden, intense exercise suffer a poorly understood metabolic storm that can end in sudden death. Risk factors include heat and poor physical conditioning.
The military has long worried about such cases: Studies decades ago found that African-American recruits with the trait had a 30 percent higher rate of exercise-related death than those without it. The Air Force screens recruits for the trait and requires precautions, not always enforced: Just three years earlier, a Lackland recruit with sickle-cell trait died after the same 1.5-mile timed run. He had never been issued the required armband to alert medics to his status.

In Mr. Moore’s case, a medical worker had scheduled a Friday appointment to inform him of his test results, sending an email to squadron leaders. But on Thursday, his situation came to a head. Squadron leaders wanted to know if he would repeat the run or should be sent home. A low-level nurse at the base clinic contacted the physicians who had seen him in the previous 48 hours.
Although both had restricted him from basic training, the Air Force report suggests they changed their minds. “Both physicians stated that the Trainee of Concern was medically qualified and simply ‘deconditioned,’ ” it states. It stresses that Mr. Moore himself reported feeling fine since his run five days earlier — the last time he had engaged in any exercise.
The nurse relayed the information to a physician assistant, Seth Kasunick, who cleared Mr. Moore; neither he nor anyone else conducted a physical examination. His note documenting the decision, written after Mr. Moore died, said he had been “informed the trainee was without health concerns.”
That afternoon, in 82-degree heat, Mr. Moore ran five laps quickly. One hundred yards from the finish line, he fell down, got up and collapsed again. He died that night of what the medical examiner later ruled were complications from sickle-cell trait.
Three independent experts who reviewed Mr. Moore’s medical records at The Times’s request agreed that medical workers had failed him. Dr. Janis Abkowitz, a well-known hematologist and medical professor at the University of Washington, said abandoning the precautions just ordered by two physicians “was a terrible error.”
Dr. Stephen Rice, a specialist recommended to The Times by the American College of Sports Medicine, said that based on Mr. Moore’s symptoms when running — especially that his legs felt very hot — physicians should have investigated whether his muscle tissue was breaking down and leaching proteins into the bloodstream. That condition, called rhabdomyolysis, has been associated with sudden death of people with sickle-cell trait who overexert. And the sickle cell test results “should have been communicated to everyone,” he said.
“There was a breakdown here, no question about it,” he said. “You have to gain some lessons here. You can’t just say this is a tragedy.”
The military’s clinicians — Dr. Mirza, Dr. Collenborne and Mr. Kasunick — did not respond to phone calls for comment. Nor did Mr. Moore’s squadron leader, Colonel Gallagher. In a statement late on Friday, the Air Force said that Mr. Moore had died from complications related to a pre-existing condition and that no one who had trained or cared for him was negligent.
Defense Department officials say it is important that patients or relatives hear directly, and promptly, from caregivers in cases of serious harm or death. Surrogates do not work because patients and families do not trust them.
But nine months after her son died, Ms. Holmes said she had only his death certificate, a condolence letter and assurances that inquiries were underway, one of which ultimately produced a report not covered by the confidentiality law. “How can you fight back when they won’t talk to you?” she asked then.
The four Air Force officers who arrived at her house the next month with that report were just messengers, with no ties to the recruit. Their message was that medical workers had come to a careful, deliberate consensus that he could safely repeat the test run. They did not address why the “thorough medical evaluation” described in the report had not been conducted. Nor did they say whether anyone had considered the sickle-cell test results.
Ms. Holmes told the officers that their remarks were scripted. “The people who were in contact with him should have been the ones who came here today,” she said. “It would make me feel so much better if they would just say, ‘We messed up,’ ” she said after reading the report they gave her on their way out. “I just want them to own up and say it, not put up some kind of front.”
In frustration, she wrote to Colonel Gallagher, the squadron leader who said at the funeral that he had not done enough to protect her son. She wanted to ask him directly what he had meant.
There was no reply.
Andrew W. Lehren contributed reporting from New York.