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Do it yourself? When the researcher becomes the subject

Poldrack in scanner
Stanford psychologist Russell Poldrack, shown here in his 105th MRI scanning session during an 18-month experiment, is one of a number of researchers who are enlisting as subjects in their own studies. TIM LAUMANN

By Esther LandhuisDec. 5, 2016 , 12:30 PM
Source: Science Magazine
Photos Source: Science Magazine

Some scientists analyze fruit flies. Others use zebrafish. Many conduct studies with mice. But occasionally, researchers choose to experiment on a different animal: themselves. Consider the medical officer who in the early 1800s fed himself spoiled sausage to determine the source of foodborne botulism. Or the physician who in 1929 performed the world’s first cardiac catheterization on himself, and the young doctor who in 1984 guzzled Helicobacter pylori broth to prove that the bacterium causes ulcers. The latter two went on to win Nobel Prizes, but others haven’t been as fortunate. During the Spanish–American War, when yellow fever was killing thousands of U.S. soldiers, physician Jesse Lazear died after intentionally exposing himself to infected mosquitoes.

Medical martyrdom is rarer these days, in part due to increased regulation of human subject research after World War II, and fewer researchers dying for their work can only be a good thing. Nonetheless, autoexperimentation continues. The access to the subject is matchless, and the allure of big data and personalized medicine seems to be some nudging self-experimenters toward new types of studies. However, the regulatory environment remains somewhat vague, leaving it up to researchers to weigh practicality against ethical considerations. But if care and diligence accompany the appetite for adventure, scientists can responsibly conduct self-experimentation studies that help advance science—and potentially offer some fun and personal benefit to boot.

Balancing ease with ethics

For scientists whose work isn’t particularly risky, it’s hard to beat a prime motivation for self-experimentation: convenience. “It’s easy to draw your own blood and analyze it,” says Laura Stark, a bioethics historian at Vanderbilt University in Nashville. “You don’t have to worry about someone suing you or deciding you can’t use their sample.”

That was a key factor when Lawrence David, a Ph.D. student at the Massachusetts Institute of Technology at the time, and his adviser, bioengineer Eric Alm, sought to monitor how daily activities influenced the human gut and oral microbiomes over the course of a year. They needed to determine feasibility limits—for example, how frequently samples could be collected and how many variables could be measured. When the researchers couldn’t immediately find participants, they decided to enroll themselves. “We thought that by participating, we’d gain firsthand understanding of those limits,” says David, now an assistant professor of molecular genetics and microbiology at Duke University in Durham, North Carolina.

Each day, the two researchers saved spit samples and pooped into sterile bags. They used an iPad app to log their weight and everything they did and ate. Several months into the study, David went to Bangkok for a few weeks but stuck with the regimen, shipping home 3 to 5 pounds of stool on dry ice. That commitment eventually paid off when the results were published.

Russell Poldrack, a psychologist at Stanford University in Palo Alto, California, also had an ambitious study plan that required more than what the average participant would tolerate. That’s what led him to climb into an MRI machine every Tuesday and Thursday morning for 18 months to get his brain scanned. The idea started simmering years before, when Poldrack’s studies to understand psychiatric disorders stalled because they lacked a good control for normal brain function variability over time. At some point, he recalls, while he was directing the Imaging Research Center at the University of Texas (UT) at Austin, artist-in-residence Laurie Frick “really started pushing me, saying, ‘You’ve got this MRI scanner. Why aren’t you getting in there and scanning yourself?’”

While Poldrack was mulling over this possibility, Stanford geneticist Michael Snyder published a 2012 paper describing an “integrative Personal Omics Profile” of a 54-year-old male volunteer—himself. Snyder’s genome was sequenced and analyzed, and over 14 months, the research team made more than 3 billion measurements of his blood, saliva, mucus, urine, and feces. During the study—conducted as a proof of principle and to learn what a baseline “healthy” state looks like—Snyder discovered that he was genetically at risk for type 2 diabetes. With that information and the accompanying data, he was able to investigate biological pathways that kicked in as he developed signs of disease, which could have implications beyond Snyder’s individual health. Seeing Snyder’s work made Poldrack think that his crazy brain study might “not just be a goofy boutique project; it could actually have some scientific impact.”

He was right: His 18-month ordeal produced the most detailed map of functional brain connectivity in a single person to date.

Despite the potential advantages of using oneself as a subject, scientists contemplating this approach should consider research ethics guidelines. In the United States, the National Institutes of Health enacted policies in 1954 that restrict the use of employees as research subjects. The National Research Act, passed by Congress in 1974, requires research involving human subjects to be vetted by an institutional review board (IRB). Current rules, which date from 1981, outline additional protections for vulnerable groups, including pregnant women, children, and prisoners. U.S. federal law does not, however, explicitly address self-experimentation by a scientist or physician, says Jonathan Moreno, a bioethicist at the University of Pennsylvania. As Stark explains, it is “a blind spot in the current human subjects regulations.” That means that, at least for now, it is up to researchers to decide whether they’re comfortable experimenting on themselves and whether they need to seek IRB approval.

Conducting research in this vague regulatory environment can create confusion, even when researchers do everything they can to make sure they’re proceeding according to regulations and requirements. Before Poldrack started his brain study, for example, he submitted a proposal to the IRB at UT Austin, where he worked at the time. The board said that it did not consider his project to be human subjects research and therefore it did not require approval, so Poldrack got started collecting his scans without worrying about any further paperwork.

About 6 months after Poldrack started collecting data, however, the situation became more complicated. Researchers at Washington University School of Medicine in St. Louis learned of the study and wanted to use some of Poldrack’s data. When they checked with their IRB to see whether a formal protocol was required, they hoped the IRB would say it was unnecessary. After all, it was data being collected at a different institution that hadn’t required IRB approval—“essentially just a data transfer from our point of view,” says M.D.-Ph.D. student Tim Laumann, one of the researchers interested in accessing the data. However, the Washington University IRB did require a protocol to be written and approved—a process that took about a month even when expedited, Laumann says.

Looking back, Poldrack suspects that things could have gone more smoothly if he had gotten IRB approval from his institution to begin with. “It would have made data sharing much easier because the data would not have been living in an ethical gray zone”—although, he adds, other aspects of the study, such as the fact the data cannot be de-identified, “might also have raised issues even with IRB approval.” In the absence of hard-and-fast rules for self-experimentation, researchers wishing to study themselves should trust their best judgment while allowing for hiccups that could arise in this less-chartered realm.

The power of doing it yourself

Beyond administrative challenges, self-experimentation studies can raise questions about whether analyses of just a few individuals are scientifically valid. Self-monitoring experiments are not randomized or blinded like traditional human studies, and the experimenter’s personal involvement and motivations could make the research seem less objective.

Despite these concerns and caveats, there are scenarios where self-experimentation may be not only acceptable but optimal. Studies such as Poldrack’s, which aim to correlate hard-to-describe personal experiences such as mood or emotion with concrete measurements, for example, are among them because the researchers have particular expertise that makes them ideal subjects. Researchers “know the categories used to describe feelings and side effects and can articulate them in a way that translates easily into scientific language,” Stark says. Self-experimentation, therefore, can offer a way to calibrate tools and technologies that are otherwise hampered by relying on an individual’s subjective experience.

And for University of California, San Francisco, neuroscientist Adam Gazzaley, who develops video games to help improve brain function, the small sample size is exactly what he wants. The video games automatically adjust their difficulty based on the user’s performance, creating a personalized digital therapy, which is a key part of his lab’s effort to shift “away from just focusing on large populations and focusing more on the individual, the n of 1,” Gazzaley says. “We’re looking to understand more about how to make meaningful statements about data from a single person.”

<p>Adam Gazzaley underwent various measurements, including EEGs, as a participant in his own studies.</p>
Adam Gazzaley underwent various measurements, including EEGs, as a participant in his own studies. JO GAZZALEY

Every once in a while, when Gazzaley gives talks about the project, someone from the audience would ask him whether he played the games himself. His answer was “no” until the summer of 2015, when Gazzaley decided to put his time where his mouth is and became a research participant. For 2 months he played an hour of Body Brain Trainer, a physical and cognitive fitness game, three mornings a week. He also did 30 minutes of a meditation game called Meditrain on weeknight evenings, and for 3 weeks he played the newest game, Neurodrummer, which aims to improve cognition through rhythm training. He also had to get numerous measurements taken via saliva and blood samples, MRIs, EEGs, sleep tracking, heart rate monitoring, and more.

“Playing games I helped invent and being in studies I helped design and validate, but doing it from the perspective of a participant, was really helpful,” Gazzaley says. Experiencing firsthand the challenges of compliance, especially for something “not as quick as a pill,” has inspired Gazzaley to develop ways to not only push people to work harder during the game but also to sustain motivation over the long haul.

As for whether he plans to publish the data collected on himself, he says he might play the games again, perhaps annually, “to get a more longitudinal view.” For now, though, the personal reasons for self-experimentation could be just as strong as the scientific motivation. Now in his late 40s, Gazzaley says he is “approaching the age range of the adults we treat in some of our older studies. We know middle-aged folks have declining cognitive control. This seemed a great way for me to try and get out in front of it.”

Regardless of why scientists engage in self-experimentation, they should be transparent, making a public statement—perhaps a paragraph in the manuscript—explaining why they’re doing a study on themselves and what they hope to learn by conducting the research this way, Moreno says. “It says the researcher isn’t just using patients as guinea pigs.” Time will tell whether these types of studies establish worth that goes beyond provocative one-offs. Then again, with certain research questions, he adds, “if you don’t give it a shot, you may never know.”

doi:10.1126/science.caredit.a1600160

Esther Landhuis

Esther Landhuis is a freelance science journalist based in the San Francisco Bay area.

Why don’t more doctors and scientist use themselves as subjects since they have confidence in their trails? Why don’t patients know about informed consent? Why don’t doctors and scientist get it? Why are clinical trials infamous for their fines? Are unethical medical experiments really a thing of the past? Why are there so many modern day instances of unethical medical experiments?

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Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark.

By Christina Jewett and Heidi de Marco  Photos by Heidi de Marco  MARCH 7, 2019
Source: Kaiser Health News

This story also ran on Tampa Bay Times and Miami Herald. This story can be republished for free (details).This story can be republished for free (details).

Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

After Dr. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did.(KENDRA STANLEY-MILLS FOR KHN)

The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.

Deaths must still be reported in MAUDE. But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. They have included surgical staplers, balloon pumps snaked into vessels to improve circulation and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.

Yet the program, in all its iterations, has been so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety. Even a former FDA commissioner said he knew nothing of the program.

Behind The Byline: Christina Jewett

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Source: Kaiser Health News
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KHN pored over reams of public records for oblique references to reporting exemptions. After months of questions to the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of never-before-acknowledged instances of malfunctions or harm.

Amid the blackout in information about device risks, patients have been injured, hundreds of times in some cases, lawsuits and FDA records show.

“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She said doctors relying just on the public reports — and unaware that many incidents may be omitted — can easily reach the wrong conclusion about the safety record of a particular device.

The FDA has also opened additional — and equally obscure — pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

I don’t want to sound overdramatic here, but it seemed like a cover-up.DR. DOUGLAS KWAZNESKI, SURGEON

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a summary report to be filed publicly.

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years.

The long-standing exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive,” Hunt said in an email.

Madris Tomes(COURTESY OF MADRIS TOMES)

To those outside the agency, though, the exceptions to the reporting rules are troubling. They strike Madris Tomes, a former FDA manager, as the agency surrendering some of the strongest oversight and transparency powers it wields.

“The FDA is basically giving away its authority over device manufacturers,” said Tomes, who now runs Device Events, a website that makes FDA device data user-friendly. “If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”

Doctors, like Kwazneski, who have turned to the public data to gauge the risks of surgical staplers have seen little. He wrote about the “unacknowledged” problem of stapler malfunctions in a 2013 article in the journal Surgical Endoscopy. In 2016, while reports of 84 stapler injuries or malfunctions were openly submitted, nearly 10,000 malfunction reports were included in the hidden database, according to the FDA.

Device maker Medtronic, which owns stapler maker Covidien, has been described as the market leader in surgical staplers. A company spokesman said that the firm has used reporting exemptions to file stapler-related reports through July 2017. Ethicon, the other major stapler maker, said it has not.

The public database shows that Medtronic has reported more than 250 deaths related to staplers or staples since 2001.

Mark Levering, 62, nearly lost his life after a stapler malfunction early last year, according to a lawsuit filed by his family. His surgeon has testified that a surgical stapler misfired during his liver surgery at ProMedica Toledo Hospital in Ohio.

Staff performed CPR for 22 minutes while surgeons rushed to suture the severed vein. He emerged from a coma unable to walk or consistently recognize his wife and son. The surgeon, hospital and device maker Covidien have denied allegations of wrongdoing in an ongoing legal case.

Told of the reporting “exemption” for surgical staplers, his wife, Doris Levering, was incredulous.

“Why would this information not be made available to doctors? The true information — I mean the actual numbers …” she said. “People’s lives are at stake. Mark’s life will never be the same.”

Doris Levering says her husband, Mark, underwent a procedure to remove an abscess from his liver and ended up in a coma for weeks.(HEIDI DE MARCO/KHN)

Phil Levering (left) says his father, Mark Levering, used to have a calm demeanor but now exhibits signs of aggression due to a brain injury he suffered after a surgery gone wrong. (HEIDI DE MARCO/KHN)

Doris Levering holds a photograph of her and her husband predating his surgery. Levering says it’s clear that the man who used to tend to stray cats and enjoy dinner out with his family is gone. “People’s lives are at stake. Mark’s life will never be the same,” she says.(HEIDI DE MARCO/KHN)

The Stapler Problem

The sheer number of malfunctions made surgical staplers an easy pick for the new alternative summary reporting program at its inception nearly 20 years ago, according to Larry Kessler, a former FDA official and now a University of Washington health services professor.

Surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.

The severity of some of the injuries caught former FDA official Brown’s attention in the early years of its reporting exemption. Her 2004 article on stapler mishaps, published in the Journal of the American College of Surgeons, accounts for one of the few places in public records where an FDA authority mentions the “alternative summary” program. She found that in the first 28 months of filing to the hidden database, stapler makers filed more than 5,100 reports of malfunctions or injuries.

Mark Levering, now 62, was in a medically induced coma and had several surgeries after a surgical stapler malfunctioned during a Feb. 17, 2018, liver surgery. His wife, Doris Levering, said in a deposition that he did not open his eyes after the initial surgery until March 13.(COURTESY OF DORIS LEVERING)

She also noted that the publicly reported 112 stapler-related deaths in patients aged 22 to 91 from 1994 to 2001 were a “reason for concern.”

In the public data filed since, it would appear that the staplers rarely misfire. In 2011, only 18 injury or malfunction reports were filed publicly. Last year, the number was 79.

Lawsuits detail how quickly a stapler failure can turn a smooth surgery into a catastrophe.

In Michigan, Eugene Snook’s surgeon was in the process of removing part of his lung when he cut but couldn’t seal a major vessel due to a “stapler malfunction,” the surgeon said in sworn court testimony. Snook, then 59, had no detectable blood pressure for four minutes during the 2012 surgery.

The damage to Snook’s artery was so great, his surgeon decided to remove his lung completely, medical records filed in court say. Snook sued stapler maker Covidien, which in court records said there was no proof the stapler was unsafe when it left Covidien’s control and also that the surgeon used it improperly. The case reached a confidential settlement in 2017.

Another surgeon attempting to remove a benign liver growth from April Strange, 33, in 2013, testified that a stapler malfunction caused the woman to bleed to death. Strange, of central Illinois, left behind a husband and two daughters, then 6 and 8.

The stapler was thrown out after surgery, court records say. Covidien argued in court records that Ryan Strange couldn’t prove that the stapler had a specific defect.

Covidien reached an agreement to settle the family’s claims for $250,000, part of a larger settlement in the case.

Doctors initially thought Mark Levering had liver cancer. So when the diagnosis came back as an abscess that needed to be surgically removed last February, it came as a relief to his wife, Doris.

That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.

Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.

After Levering reopened his eyes, it was clear that the man who used to tend to stray cats and enjoy dinner out with his family was gone. Levering could no longer walk, comb his hair or recognize the letters of the alphabet.

KHN Video: Phil Levering Discusses His Father's Surgery

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Source: Kaiser Health News
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Doris and Mark Levering have sued the doctor, hospital and surgical stapler maker, alleging that the device caused Mark’s bleeding and brain injury. The surgeon has acknowledged in sworn testimony that the stapler malfunctioned, but denied other wrongdoing. The hospital said in a legal filing that its actions were “prudent, proper” and “lawful.”

Covidien denies any defect with the stapler or that it caused Levering’s injuries. A spokesman for parent company Medtronic declined to comment further on any lawsuit but said that “we always make patient safety our top priority” and that the company complies with FDA requirements.

The company’s reports of stapler problems in the public database remain relatively low. But in 2018, with the reporting exemption gone, a spike of reports emerged for Covidien’s staples — not to be confused with staplers. While Medtronic reported 1,000 staple malfunctions or injuries in 2015, the number soared to 11,000 for 2018.

KHN Video: Doris Levering Discusses Her Husband's Brain Injury

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Source: Kaiser Health News
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Rolling Out The Program

The alternative summary reporting program started two decades ago with a simple goal: to cut down on redundant paperwork, according to officials who were at the FDA at the time.

Kessler, the former FDA official, said the program took shape after scandals over under-reporting of device problems spurred changes allowing criminal penalties against device companies.

Soon, thousands of injury and malfunction reports poured into the agency each month, with about 15 staff members dedicated to reviewing them, Kessler said. Many reports were so similar that reviewing them individually was “mind-numbing.” Kessler went to the FDA’s legal department and to device manufacturers to propose a solution.

Device makers would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year or year.

That way, Kessler said, reviewers could quickly look for new problems or spikes in known issues. When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, Kessler said.

“I don’t know why it’s not [made public] now,” he said. “I’m surprised about that.”

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

The FDA declined to provide a complete list of “about 100” devices that have been granted reporting exemptions over the years, but confirmed that exemptions have been used for mechanical breathing machines and balloon pumps, known as intra-aortic balloon pumps, inserted in the vessels of people with circulation problems.

An FDA spokeswoman said “alternative summary” exemptions remain in place for pacemaker electrodes and implantable defibrillators.

Matthew Baretich, a biomedical engineer in the Denver area, said he helps several area health systems analyze device-related patient injuries and make equipment-purchasing decisions.

He said he regularly scans the FDA’s public device-injury reports. Asked about “alternative summary” reports, he said, “I’ve got to tell you, that’s a new term to me.”

Bruce Barkalow, president of a Michigan-based biomedical engineering firm, said he’s the guy government officials, attorneys or device makers call if someone gets a pacemaker and dies in the shower three days later.

In an interview, he said he was not aware of the reports, either. He said they may appear to the FDA to be a “nothing burger,” but the data would be meaningful to his forensic investigations.

The ECRI Institute, a nonprofit leader in medical device safety, declined to provide an engineer for an interview. Educating hospital leaders and health providers, the institute issues an annual “Top 10” in medical technology hazards. Its tagline: “Separating fact from fiction in healthcare.”

Among the institute’s “top medical device subject matter experts,” spokeswoman Laurie Menyo said in an email, “none of them had any familiarity with FDA’s Alternative Summary Reporting Program.”

Even Dr. Robert Califf, former FDA deputy commissioner and commissioner from 2015 to 2017, said in an interview that he was unaware of the program. “Never heard anything about it,” he said. “It’s interesting.”

Companies that get the exemptions tend to be very “tight-lipped” about them, said Christine Posin, a former device firm manager and consultant to device companies.

The relative secrecy around the program can give them an advantage, she said. For instance, sales representatives can print out only the public reports of device problems, ignoring what’s buried elsewhere.

That creates a business opportunity to persuade a doctor to try a different device. “‘We have a good product that does the same thing,’” Posin said a sales representative might tell a physician.

Exemptions Multiply

The FDA has spent millions, convened experts and pledged to improve its work in device safety in recent years. All the while, it has quietly opened new avenues for the makers of controversial and risky devices to file injury and even death reports with little public review.

Pelvic mesh is one example. The fabric-like device has long been used to hold up pelvic organs in women experiencing organ prolapse. In 2011, the FDA issued a “safety communication” saying “serious complications” like pain or infection were “not rare.”

The agency soon reclassified the device, ordered safety studies and saw most mesh makers remove the device from the market.

Behind closed doors, though, the agency has since granted pelvic mesh makers a special exemption from reporting injuries to the public, according to the FDA and mesh makers who were asked about the practices.

Under what the FDA calls the “litigation complaint summary reporting” exemption, device makers can file a single “injury” report. Attached to the summary report, device makers have sent the FDA a spreadsheet with as many as 1,175 reports of patient injuries, based on allegations in lawsuits.

To someone tallying the overall number of injuries related to pelvic mesh, the report would appear as a single injury. It would take a sharp eye to find the summary report and a special request — taking up to two years to be filled — to get the details on the 1,175 cases submitted directly to the FDA.

According to the FDA, in 2017 alone, eight mesh makers used their exemptions to send nearly 12,000 injury reports to the FDA.

The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.MADRIS TOMES, FORMER FDA MANAGER

Dr. M. Tom Margolis, a urogynecologist in the San Francisco Bay Area and an expert medical witness for those who are suing mesh makers, said a program that might hinder doctors relying on open FDA data to assess the risks of mesh is “horrible” and “unethical.”

“We need to know the good and the bad,” said Margolis, who treats patients in his urogynecology practice. “If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.”

The FDA issued the same kind of exemption to the makers of da Vinci surgical robots months after Johns Hopkins University School of Medicine researchers pointed out that the company was filing a notably small number of injury reports in the public database. Johns Hopkins professor Dr. Marty Makary noted in 2013 that the handful of reports sent to the FDA at the time were signs of a “haphazard” system that is “not independent and not transparent.”

Within months, the FDA allowed the makers of the robots to file a single report, noting that a spreadsheet sent straight to the FDA summarizes about 1,400 injuries alleged in lawsuits, with some injuries dating to 2004. Since then, the device maker has reported smaller batches of 99 and 130 injuries at a time.

Homa Alemzadeh(COURTESY OF HOMA ALEMZADEH)

“This is very frustrating,” said Homa Alemzadeh, an assistant professor of computer engineering at the University of Virginia who is working with MAUDE data to create software to identify errors in real time or before they happen in surgeries performed by robots. She said she was not aware of the reporting exemption.

Under another reporting exemption, the FDA is allowing device makers to report hundreds of death cases in spreadsheets sent directly to the agency.

Under the “registry exemption,” device makers can summarize what they learn from registries that tend to be held by specialty medical societies, and track the use of a certain kind of device, according to FDA spokeswoman Kotz.

Kotz said the data in registries often falls short of the level of detail that the FDA seeks for the more thorough death reports that device makers are required to file.

Device makers filing such reports include Edwards Lifesciences, which makes the Sapien 3 valve that’s snaked through a vessel and implanted in the heart. Some hail the device as a breakthrough for saving patients from the trauma of open-heart surgery to replace a valve. Others raise concerns over limited data showing how long the valve will last in the body.

The summary reports offer potential patients few answers. Such reports document as many as 297 deaths or 1,800 injuries in a single filing, with virtually no detail readily available to the public. In all, Edwards has filed more than 1,800 Sapien 3 valve patient deaths as summaries since 2016.

Edwards spokeswoman Sarah Huoh said in an email that the FDA mandated the tracking of every patient who has the valve in the registry to provide “comprehensive evidence for device safety.”

“The approval of alternative reporting protects against duplicate reports coming from multiple sources,” Huoh said.

Another device, the MitraClip, is used to attach two flaps in the heart that are allowing blood to flow backward. The device has been controversial, with some scientists saying it is crucial for a certain subset of patients, and others pointing to the harm it can cause to the heart.

The FDA has allowed Abbott Vascular, which makes the MitraClip, to report as many as 347 deaths or 1,000 injuries in a single filing, also shipping the details straight to the agency, FDA records show.

An Abbott spokesman said in an email that the company has done clinical trials with thousands of patients to establish the MitraClip’s safety. He said the exemption was granted because data in the registry was stripped of patient identifiers, making it hard to know whether the company would be filing redundant reports to the FDA.

We need to know the good and the bad. If you’re trying to hide complications from me, well that’s … wrong, my God, it’s heinous.DR. M. TOM MARGOLIS, UROGYNECOLOGIST AND EXPERT MEDICAL WITNESS

Last year, the FDA finalized regulations for yet another summary reporting program. Under the newest system, device makers do not have to seek an exemption or notify the FDA that they’ll be filing a public summary report in MAUDE.

The FDA has deemed the makers of more than 5,600 types of devices eligible to file “voluntary malfunction summary reports.” Among them are some of the riskiest devices the agency oversees, including cardiac stents, leadless pacemakers and mechanical heart valves.

The growing cadre of exceptions to the injury- and death-reporting rules strikes Dr. Michael Carome, director of the Public Citizen Health Research Group, as a retreat by the FDA from making crucial information available for researchers and patients.

“It’s just another example of a flawed oversight system,” he said, “bent toward making it easier for industry rather than making protection of public health the primary goal.”

California Healthline reporter and producer Heidi de Marco contributed to this report.

[Correction: A previous version of this story mischaracterized FDA spokeswoman Alison Hunt’s description of the reports that go into a new FDA exemption program. It has been revised to eliminate the term “placeholder.”]

KHN’s “Hidden Harm” series on the FDA’s secret database of malfunctioning medical devices was honored on Oct. 2, 2019, with the prestigious Barlett & Steele Award for Investigative Journalism. The series prompted the FDA to publish its entire hidden database online, revealing 5.7 million device-related injuries or malfunctions.

Christina Jewett: ChristinaJ@kff.org@by_cjewett

Heidi de Marco: heidid@kff.org@Heidi_deMarco

KHN Video: Doris Levering: 'Nothing Will Ever Be The Same'

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Source: Kaiser Health News
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Why are this reports hidden? What would you like to see the FDA do? Why aren’t conflicts of interest reported as required by the FDA? How does this government agency that should work for you, truly work for you?

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You Might Be in a Medical Experiment and Not Even Know It

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By Alice Dreger, January 31, 2017 1:34 PM
Source: Discover Magazine
Feature Photo Source: Unsplash, Hush Naidoo 

In the long view, modern history is the story of increasing rights of control over your body – for instance, in matters of reproduction, sex, where you live and whom you marry. Medical experimentation is supposed to be following the same historical trend – increasing rights of autonomy for those whose bodies are used for research.

Indeed, the Nuremberg Code, the founding document of modern medical research ethics developed after the Second World War in response to Nazi medical experiments, stated unequivocally that the voluntary, informed consent of the human subject is essential. Every research ethics code since then has incorporated this most fundamental principle. Exceptions to this rule are supposed to be truly exceptional.

Yet today, more and more medical experimenters in the United States appear to circumvent getting the voluntary, informed consent of those whose bodies are being used for research. What’s more, rather than fighting this retrograde trend, some of the most powerful actors in medical research are defending it as necessary to medical progress.about:blankabout:blank

A few years ago, I fell in with a growing group of professionals in medicine and allied fields such as bioethics who have mobilised to defend the right to informed consent in medical experimentation. As a historian of medicine, I had worked since 1996 with intersex rights activists on improving care for children born with bodies in between the male and female types. In 2009, colleagues alerted me that a group of parents judged ‘at risk’ of having a child born with a particular genetic intersex condition appeared to be unwitting subjects in a medical experiment.

A major researcher and physician was promoting the prenatal use of a drug (dexamethasone) aimed at preventing intersex development. Targeting would-be parents who knew they had this condition running in their families, the researcher told them that the ‘treatment’ had been ‘found safe for mother and child’.

In fact, the US Food and Drug Administration (FDA) has not approved dexamethasone for preventing intersex development, much less found it ‘safe’ for this use. Indeed, the FDA has noted dexamethasone causes harm in foetal animals exposed to it. No one seems to have told the parents that this ‘treatment’ had not gone through anything like the normal route of drug approval: there has been no animal modelling of this use, no blinded control trial for effectiveness, and no long-term prospective safety trials in the US, where thousands of foetuses appear to have been exposed.

Shockingly, at the same time that this researcher was pushing the ‘treatment’ as ‘safe’, she was obtaining grants from the US National Institutes of Health (NIH) to use the same families in retrospective studies to see if it had been safe. A Swedish research group has recently confirmed – through fully consented, prospective studies – that this drug use can cause brain damage in the children exposed prenatally.

As I sought allies in defending the rights of these families, I discovered that, while this was an especially egregious case of failure to obtain informed consent to what amounted to a medical experiment, the lapse was not unique. Public Citizen’s Health Research Group, a Washington-based NGO, has been leading the work in tracking cases where medical researchers fail in their obligations to obtain informed consent.about:blankabout:blank

Recently, Public Citizen, together with the American Medical Student Association, sounded an alarm about two clinical trials, one called iCOMPARE, the other FIRST. In these studies, researchers extended the working hours of newly trained physicians to see if these physicians and their patients were better or worse off with the most inexperienced doctors working longer, more tiring shifts.

The young doctors used in these studies were not given the option of not participating. If their residency programmes participated, they were in. More concerning, their patients were never informed that they were experimental subjects, even though a primary research goal was to see if patients treated by residents working longer shifts would experience higher rates of harm.

Some studies tracked by Public Citizen reveal downright bizarre ethical mistakes. A recent study funded by the US Department of Health and Human Services, led by a US Department of Veterans Affairs researcher, sought to determine whether, if brain-dead kidney donors’ bodies were cooled after brain death, living recipients of the transplanted kidneys did better. The researchers decided they didn’t need to get voluntary consent to the experiment from the living kidney recipients. They simply maintained the dead donors were the experimental subjects.

The largest contemporary fight over failure to obtain informed consent has been over the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (or SUPPORT). This was a large NIH-funded study meant to determine, in part, whether higher or lower levels of oxygen after birth provided very premature babies with benefit or harm. The consent forms for this study did not inform the parents that the experiment’s purpose was to see if, by being randomly assigned to one of two experimental oxygen ranges, babies end up more likely to be blind, neurologically damaged or die.

Most parents also weren’t informed that the researchers would use experimental measuring devices meant to ‘blind’ professional caregivers to the babies’ real oxygen levels to try to make the study more rigorous. Researchers told many parents that the study involved no special risks because all the procedures in the research were supposedly standard of care. This was a demonstrably untrue claim.

In this case, the US Office for Human Research Protections (OHRP) – an agency meant to protect the rights of people in federally funded research – agreed with Public Citizen and an allied group of more than 40 of us in medicine and bioethics that the informed consent for this trial was seriously inadequate. But in a series of emails meant to stay private, top NIH officials pressured the OHRP to back off its criticisms. OHRP is supposed to oversee NIH’s work, not the other way around!

NIH leaders also partnered with the editor of The New England Journal of Medicineto publicly defend this study. The journal’s editor-in-chief tried actively to limit the ability of us critics to respond. Meanwhile, the parents were never officially informed of what happened to their babies.

Those defending these troubling studies often argue that elaborate consent procedures can get in the way of obtaining important scientific results. They say that subjects might encounter the risks of the experiment even in ‘normal’ patient care, so we might as well engage them in studies without scaring them off through frightening research consent forms.

It is true that the current research ethics system in the US is cumbersome, inefficient and dysfunctional. Researchers often find themselves confused and frustrated by the bureaucracies of research ethics systems.

But that is no excuse not to vigorously maintain the first principle of the Nuremberg Code: the voluntary consent of the subject is essential. We can’t afford the risk to medical research that sloppy ethics entail; when the public finds out about the circumvention of informed consent – as in the case of the infamous US Public Health Service syphilis study at Tuskegee – the damage to the integrity and authority of the medical research community is inevitably significant and long-lasting.about:blank

The tenets of the Nuremberg Code were not meant only for Nazis. If Nazis presented the only danger to people being used for medical experiments, eliminating the Nazis would have solved our problems. The Nuremberg Code was written to guide all of us, because good intentions are not enough.

This article was originally published at Aeon and has been republished under Creative Commons.

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THE NUREMBERG CODE AND ITS IMPACT ON CLINICAL RESEARCH

Posted by Natalie Jarmusik on Tue, Apr 9, 2019
Source: IMA Research

Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects. 

What Is the Nuremberg Code?

When World War II ended in 1945, the victorious Allied powers enacted the International Military Tribunal on November 19th, 1945.  As part of the Tribunal, a series of trials were held against major war criminals and Nazi sympathizers holding leadership positions in political, military, and economic areas.  The first trial conducted under the Nuremberg Military Tribunals in 1947 became known as The Doctors’ Trial, in which 23 physicians from the German Nazi Party were tried for crimes against humanity for the atrocious experiments they carried out on unwilling prisoners of war.  Many of the grotesque medical experiments took place at the Auschwitz concentration camp, where Jewish prisoners were tattooed with dehumanizing numbers onto their arms; numbers that would later be used to identify their bodies after death.

The Doctors’ Trial is officially titled “The United States of America v. Karl Brandt, et al.,” and it was conducted at the Palace of Justice in Nuremberg, Bavaria, Germany.  The trial was conducted here because this was one of the few largely undamaged buildings that remained intact from extensive Allied bombing during the war.  It is also said to have been symbolically chosen because it was the ceremonial birthplace of the Nazi Party.  Of the 23 defendants, 16 were found guilty, of which seven received death sentences and nine received prison sentences ranging from 10 years to life imprisonment. The other 7 defendants were acquitted. 

The verdict also resulted in the creation of the Nuremberg Code, a set of ten ethical principles for human experimentation. 

What Are The Nuremberg Code’s Ethical Guidelines For Research?

The Nuremberg Code aimed to protect human subjects from enduring the kind of cruelty and exploitation the prisoners endured at concentration camps. The 10 elements of the code are: 

  1. Voluntary consent is essential
  2. The results of any experiment must be for the greater good of society
  3. Human experiments should be based on previous animal experimentation
  4. Experiments should be conducted by avoiding physical/mental suffering and injury
  5. No experiments should be conducted if it is believed to cause death/disability
  6. The risks should never exceed the benefits
  7. Adequate facilities should be used to protect subjects
  8. Experiments should be conducted only by qualified scientists
  9. Subjects should be able to end their participation at any time
  10. The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur

Want to learn more about the history of clinical research? Take a minute to watch the video and explore our History of Clinical Research timeline for more detail.

The History of Clinical Research Timeline by IMARC Research

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Source: IMA Research
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The Significance Of The Nuremberg Code

The Nuremberg Code is one of several foundational documents that influenced the principles of Good Clinical Practice (GCP)

Good Clinical Practice is an attitude of excellence in research that provides a standard for study design, implementation, conduct and analysis. More than a single document, it is a compilation of many thoughts, ideas and lessons learned throughout the history of clinical research worldwide.

Several other documents further expanded upon the principles outlined in the Nuremberg Code, including the Declaration of Helsinki, the Belmont Report and the Common Rule. 

Although there has been updated guidance to Good Clinical Practice to reflect new trends and technologies, such as electronic signatures, these basic principles remain the same. The goal has always been—and always will be—to conduct ethical clinical trials and protect human subjects. 

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Unauthorized Medical Experiments

5 Shocking Medical Experiments on Humans

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5 Shocking Medical Experiments
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What is worse than a lie? Perhaps a lie that puts your health and very life at risk. The subjects of these unauthorized experiments probably know all to well. Blue cross blue shield reported that medical fraud alone is said to cost tax payers over $68 billion dollars annually. History both modern and recent history s rife with unauthorized experiments and medical products that are currently pushed out to market with little to no clinical trail passing though several loop holes. Do you think people in the service should be subject to medical experiments without their knowledge or permission? Do you think anyone should be subject to a medical experiment without their knowledge or consent? Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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