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FDA warns of medical device hack vulnerability

Shidonna Raven Garden and Cook

Published: March 3, 2020 at 4:19 p.m. ET
By Wallace Witkowski
Source: Market Watch
Feature Photo Source: Unsplash, Ehimetalor Akhere Unuabona

Certain chips used in medical devices may be vulnerable to hackers through their Bluetooth functions, the Food and Drug Administration said Tuesday. The FDA said that SweynTooth, also known as Bluetooth Low Energy, used in medical devices such as pacemakers, stimulators, blood glucose monitors and insulin pumps, is vulnerable to hackers who can use the Bluetooth function to crash or compromise the device. Chip suppliers affected by the vulnerability include Texas Instruments Inc. TXN, -1.47%, NXP Semiconductors NV NXPI, -4.32%, Cypress Semiconductor Corp. cy, Dialog Semiconductors PLC DLG, +1.14%, Microchip Technology Inc. MCHP, -3.08%, STMicroelectronics NV STM, -0.95%, and Telink Semiconductor, the FDA said. “To date, the FDA is not aware of any confirmed adverse events related to these vulnerabilities,” the agency said in a statement. “However, software to exploit these vulnerabilities in certain situations is publicly available.”

About the Author

Wallace Witkowski

Wallace Witkowski came to MarketWatch from the Associated Press in New York, where he was a business reporter specializing in pharmaceutical companies. He previously reported for trade publications in covering the drug and medical-device industries back to 1998. Based in San Francisco, his focus is on U.S. equities. Follow Wally on Twitter at: @wmwitkowski.

How many medical devices include unauthorized experiments? Are medical professionals using technology to put people’s lives at risk and commit medical fraud? What should be done?

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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

Shidonna Raven Garden and Cook
Source: Kaiser Health News
Shidonna Raven Garden and Cook

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

Shidonna Raven Garden and Cook
Source: Kaiser Health News
Shidonna Raven Garden and Cook

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

Shidonna Raven Garden and Cook
Source: Kaiser Health News
Shidonna Raven Garden and Cook

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'

Shidonna Raven Garden and Cook
Source: Kaiser Health News
Shidonna Raven Garden and Cook

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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FDA and NIH let clinical trial sponsors keep results secret and break the law

DAVIDE BONAZZI/SALZMAN ART

Source: Science Magazine
By Charles PillerJan. 13, 2020 , 11:00 AM

For 20 years, the U.S. government has urged companies, universities, and other institutions that conduct clinical trials to record their results in a federal database, so doctors and patients can see whether new treatments are safe and effective. Few trial sponsors have consistently done so, even after a 2007 law made posting mandatory for many trials registered in the database. In 2017, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) tried again, enacting a long-awaited “final rule” to clarify the law’s expectations and penalties for failing to disclose trial results. The rule took full effect 2 years ago, on 18 January 2018, giving trial sponsors ample time to comply. But a Science investigation shows that many still ignore the requirement, while federal officials do little or nothing to enforce the law.

Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline. As of that date, those habitual violators had failed to report any results for 67% of their trials and averaged 268 days late for those and all trials that missed their deadlines. They included such eminent institutions as the Harvard University–affiliated Boston Children’s Hospital, the University of Minnesota, and Baylor College of Medicine—all among the top 50 recipients of NIH grants in 2019.

The violations cover trials in virtually all fields of medicine, and the missing or late results offer potentially vital information for the most desperate patients. For example, in one long-overdue trial, researchers compared the efficacy of different chemotherapy regimens in 200 patients with advanced lymphoma; another—nearly 2 years late—tests immunotherapy against conventional chemotherapy in about 600 people with late-stage lung cancer.

Other leading NIH grantees did only slightly better in Science’s analysis based on data collected from the TrialsTracker website of the University of Oxford, which automatically mines information from ClinicalTrials.gov. The University of Texas MD Anderson Cancer Center and the Mayo Clinic both failed to report results on time, or at all, in about two-thirds of their trials. Yale University failed to do so in 84% of its trials. NIH’s own institutes also had a bad record. They are directly responsible for reporting results when they sponsor studies done by agency staff or some grantees, and the top four NIH institute sponsors, taken together, reported results late or not at all in more than six of every 10 trials Science looked at.

Contacted for comment, none of the institutions disputed the findings of this investigation. In all 4768 trials Science checked, sponsors violated the reporting law more than 55% of the time. And in hundreds of cases where the sponsors got credit for reporting trial results, they have yet to be publicly posted because of quality lapses flagged by ClinicalTrials.gov staff (see sidebar).

Although the 2017 rule, and officials’ statements at the time, promised aggressive enforcement and stiff penalties, neither NIH nor FDA has cracked down. FDA now says it won’t brandish its big stick—penalties of up to $12,103 a day for failing to report a trial’s results—until after the agency issues further “guidance” on how it will exercise that power. It has not set a date. NIH said at a 2016 briefing on the final rule that it would cut off grants to those who ignore the trial reporting requirements, as authorized in the 2007 law, but so far has not done so.

Missed deadlines

Among more than 4700 clinical trials examined by Science, less than 45% had their results reported early or on time to ClinicalTrials.gov.150631.6%Not reported113223.7%213044.7%Reported ontime or earlyReported late(GRAPHIC) N. DESAI/SCIENCE; (DATA) CLINICALTRIALS.GOV, VIA TRIALSTRACKER

Many scientists who conduct clinical trials, and their sponsors or funders, have downplayed concerns about late or missing results in ClinicalTrials.gov. Researchers, doctors, and patients can instead learn about trial outcomes from peer-reviewed publications, they say. But thousands of trials are never published, particularly when they find treatments ineffective, history has shown. ClinicalTrials.gov also uses a common format, allowing relatively easy comparisons of results across trials that journal articles rarely make possible. Doctors, researchers, and potential trial participants rely on the site, to judge from its 215 million monthly page views.

Deborah Zarin, a physician at Brigham and Women’s Hospital and Harvard who headed ClinicalTrials.gov between 2005 and 2018, says the Science findings show failures of the research culture, FDA, and NIH. “If this was a priority for the leadership of NIH, then they could ensure that high-quality, timely reporting happened all of the time,” says Zarin, an NIH-paid research consultant for the database. “You can set up processes so trial reporting is an expectation. You can’t pass ‘go’ and collect $200 until this is done.”

Zarin, who works in a program to advance clinical research, adds that the problem persists because “reporting to ClinicalTrials.gov is frequently seen by sponsors, funders, and trialists as an annoying administrative and perhaps legal burden, not a scientific imperative. Human nature being what it is, people follow the requirements when forced to do so.”

NIH and FDA officials do not seem inclined to apply that pressure. Lyric Jorgenson, NIH deputy director for science policy, says her agency has been “trying to change the culture of how clinical trial results are reported and disseminated; not so much on the ‘aha, we caught you,’ as much as getting people to understand the value, and making it as easy as possible to share and disseminate results.” To that end, she says, ClinicalTrials.gov staff have educated researchers about the website and improved its usability.

As for FDA, Patrick McNeilly, an official at the agency who handles trial enforcement matters, recently told an industry conference session on ClinicalTrials.gov that “FDA has limited resources, and we encourage voluntary compliance.” He said the agency also reviews reporting of information on ClinicalTrials.gov as part of inspections of trial sites, or when it receives complaints.

McNeilly declined an interview request, but at the conference he discounted violations of ClinicalTrials.gov reporting requirements found by journalists and watchdog groups. “We’re not going to blanketly accept an entire list of trials that people say are noncompliant,” he said. Such determinations require “nonpublic information” submitted to the agency by trial sponsors. In response to Science’s findings, a spokesperson said an absence of posted results on ClinicalTrials.gov did not mean a trial sponsor has broken the 2007 law.

Yet that law and the 2017 final rule detail only a few exemptions that would allow trial sponsors to withhold results on the basis of nonpublic information. The very few registered trials that qualify for those exemptions are not flagged as violators by TrialsTracker or in Science’s analysis.

CONGRESS APPROVED THE CREATION OF ClinicalTrials.gov in 1997, after allegations that patients were harmed because companies withheld evidence showing their medicines were ineffective or hazardous. A widely cited case involved the GlaxoSmithKline antidepressant Paxil (paroxetine). According to legal filings and a report in The BMJ, the firm held secret data showing that in clinical trials the drug was ineffective and caused suicidal thoughts in teenagers, yet encouraged doctors to prescribe it for young people.

Registration was only required initially for trials of treatments for serious or life-threatening diseases. But the 2007 law, the Food and Drug Administration Amendments Act, required sponsors to register a much broader range of trials within 21 days of enrolling the first patient, and to post summary results, adverse events, and other data to ClinicalTrials.gov within 1 year of collecting the last patient data. Although many trials, such as industry-sponsored early-stage evaluations of drug safety, are exempt from reporting, about 326,000 have been registered, and results have been posted for more than 40,000.

Yet until 2015, even the most active investigators at clinical research institutions treated the law more as a suggestion—not surprising given that the government enforced no penalties and did not publicly identify violators. A report on the news website STAT by this author and Talia Bronshtein first drew significant attention to specific trial sponsors—companies, government agencies, universities, and individuals—that routinely ignored reporting requirements. It sparked immediate improvement, according to NIH. (Those same authors documented some of that improvement in a 2018 STAT article.)

At a 2016 press briefing, NIH and FDA rolled out the final rule, aimed at boosting even greater compliance with the 2007 law. It took effect in January 2017, with first deadlines for results, and ostensibly enforcement, 1 year later. Then–FDA Commissioner Robert Califf said it would thereafter “be pretty hard to hide that you are doing a clinical trial or hide the result.” FDA, he vowed, was finally prepared, if necessary, to enforce the daily $10,000 penalty for noncompliance allowed under the law. (Adjusted for inflation, that figure recently rose above $12,000.)

“I don’t think anybody wants to be on the wall of shame,” NIH Director Francis Collins said at the press event, promising that NIH would publicly flag reporting violations on ClinicalTrials.gov itself.

“We are serious about this,” Collins said, threatening for the first time to enforce provisions of the 2007 law that allow NIH to rescind funding to grantees who violate the statute. “It’s hard to herd cats, but you can … take their food away,” he said. “This is about maintaining the trust that we have with participants in clinical trials. … If we fail to live up to that expectation, then that is an ethical failure.”

Three years later, TrialsTracker conservatively estimates that FDA could have collected more than $6 billion in ClinicalTrials.gov penalties so far. The agency has yet to demand a single dollar. And despite more than 2600 trials for which results are overdue or were filed late, NIH has yet to withhold a single grant as a result or post a single violation notice on ClinicalTrials.gov. No “wall of shame” exists.

“Public-facing websites run by the government should be accurate. That’s not asking much,” Senator Chuck Grassley (R–IA), who advocated for the 2007 law, wrote in an email after reviewing a summary of the Science findings. “It’s a question of basic management and agency competence. The government has a duty to police its work product, especially because the public trusts .gov websites will be accurate and reliable.”

To physician Ben Goldacre, who directs the Oxford program behind TrialsTracker, “The lack of urgency is really troubling.”

Why do you think so few clinical trail results and information is not submitted? What is the cost to taxpayers, patients and the community? Why? Do you trust this process?

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Coronavirus clinical trials are pausing over safety concerns – here’s what that means

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Source: CNBC
PUBLISHED THU, OCT 15 2020 6:00 AM EDT UPDATED THU, OCT 15 20209:02 PM EDT
Berkeley Lovelace Jr.@BERKELEYJR

  • J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.”
  • Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns.
  • Pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts say.

Coronavirus clinical trials from drug giants Johnson & Johnson and Eli Lilly hit a snag this week after safety monitors halted them over bad reactions from participants.

J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.” Less than 24 hours later, Eli Lilly said its late-stage trial of its leading monoclonal antibody treatment for the coronavirus had been paused by U.S. health regulators over potential safety concerns. The pauses are likely to add to concerns about the safeness of potential Covid-19 vaccines or treatments.

But pauses to clinical trials are not uncommon, and the delays should reassure the public that the systems in place intended to protect volunteers are working, medical experts said in phone interviews with CNBC.WATCH NOWVIDEO04:02Jim Cramer: Eli Lilly pausing antibody trial isn’t a big setback

The data and safety monitoring board, an independent group of experts who oversee U.S. clinical trials to ensure the safety of participants, recommends a pause to a clinical trial any time there is an “adverse event,” said Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto. The pause will take as long as needed to gather all information and does not necessarily mean there is a problem with the vaccine or treatment, he said.

“The DSMB will say let’s push pause on this,” said Bogoch, who is also a member of the group and is overseeing other clinical drug trials. “They will say, ‘we need more data and let’s see if this person was in the vaccine group or in a placebo group.’ They’ll say, ‘let’s see what the actual illness is and use all the data at our disposal to determine whether this was a true side effect from the vaccine and if so, decide if it is safe to proceed with this study.’”

Pauses happen all the time, especially in large clinical trials with older adults, according to Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Offit, a past member of the CDC’s Advisory Committee on Immunization Practices, said “adults get sick” and sometimes “they are going to get sick in the same period of time” of getting a vaccine or treatment.

“Johnson & Johnson’s vaccine is designed to prevent Covid-19. It is not designed to prevent everything else that happens in life,” he said. “You’re always going to be sorting out those temporal associations. Strokes, heart attacks, neurological problems. Always. You always err on the side of caution and make sure that this isn’t a problem and then continue again.”

Bogoch echoed those remarks, adding, “no one before Covid-19 cared when there was a pause on a clinical trial for an antibiotic or heart medication.”

“Never have we been in a scenario where you truly have 7 billion people watching intently and following every single bit of progress under a microscope,” he said. “You know, it’s fascinating and it’s good. It creates a more health literate community. There is only good that can come of it.”

He added a pause isn’t the same as a regulatory hold, sometimes referred to as a “clinical hold.”  A clinical hold is imposed by a health authority, like the Food and Drug Administration, he said.

“It’s a little more serious when you get to a regulatory hold,” he said. “That’s actually when the FDA steps in and say we’re concerned about a particular event and we’re going to stop this trial because we don’t think it’s safe to proceed with the data that we have available at this point in time.”

The FDA still has a late-stage clinical trial from AstraZeneca, a front-runner in the Covid-19 vaccine race, on hold in the United States. That means the company is unable to administer second doses of its two-dose vaccine regimen to U.S. participants.

The company announced on Sept. 8 that its trial had been put on hold due to an unexplained illness in a patient in the United Kingdom. The patient is believed to have developed inflammation of the spinal cord, known as transverse myelitis. The trial has since resumed in the U.K. and other countries but is still on hold in the U.S.

It remains unknown what reactions the participants in J&J’s and Eli Lilly’s trials had.

Offit said companies will sometimes claim they are protecting the confidentiality of the patient, but he disagreed with the behavior. “As long as you can’t identify the person, they can give you a fair amount of information about the person, but they don’t,” he said.

Dr. Mathai Mammen, global head of research and development at J&J’s Janssen arm, told investors on a conference call Tuesday that the company still had “very little information” on the reason for the holdup, including if the patient received the vaccine or the placebo. “It’ll be a few days at minimum for the right information to be gathered,” he added.

Dr. Ezekiel Emanuel, a former health advisor in the Obama administration, said it would “raise serious questions” if the participant received the vaccine.

“One adverse event is serious, especially when you’re considering a vaccine that you’re going to roll out to tens, hundreds of millions of people, maybe even billions,” he said Tuesday on CNBC’s “Squawk Box.” “That’s the ultimate concern.”

Eli Lilly and the National Institutes of Health did not disclose what the “safety” concern was either, but Eli Lilly said it was “supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” spokeswoman Molly McCully told CNBC. 

Indeed, the whole world is on edge for the first time in “modern” history with over 1 Million dead global (as reported by Wikipedia) from COVID 19 and even more cases. People are waiting for a solution and the end of the pandemic. How important is a vaccine to you and yours? Is a safe and effective vaccine more important to you than simply a vaccine? Will you take the vaccine once it is here?

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White House Blocks New Coronavirus Vaccine Guidelines

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Source: The New York Times
Featured Photo Source: Unsplash, Sharon Mccutcheon
The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

Sharon LaFraniere
Noah Weiland

By Sharon LaFraniere and Noah Weiland

WASHINGTON — Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.

Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.

The struggle over the guidelines is part of a monthslong tug of war between the White House and federal agencies on the front lines of the pandemic response. White House officials have repeatedly intervened to shape decisions and public announcements in ways that paint the administration’s response to the pandemic in a positive light.

That pattern has dismayed a growing number of career officials and political appointees involved in the administration’s fight against a virus that has claimed more than 209,000 lives in the United States.

The vaccine guidelines carry special significance: By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.

“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” the biotech industry’s trade association pleaded on Thursday, in a letter to President Trump’s health secretary, Alex M. Azar II, asking for release of the guidelines.

The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely.

A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity. Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before Election Day.

The conflict began almost as soon as the Food and Drug Administration submitted the guidelines to the White House budget office on Monday, Sept. 21. The next day, Dr. Stephen M. Hahn, the F.D.A. commissioner, briefed Mr. Azar on the matter.

That Wednesday, Mr. Meadows raised a series of concerns, a senior administration official said. He questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr. Hahn was overly influenced by his agency’s career scientists. The White House on Monday did not respond to a request for comment.

Speaking to reporters on Sept. 23, Mr. Trump publicly cast doubt on whether the guidance would be approved. “We may or may not approve it,” he said, suggesting that the regulatory action “was a political move more than anything else.”

F.D.A. officials later provided additional justification to the White House, explaining that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19, the disease caused by the coronavirus, was not short-lived. But they have been unable to break the stalemate.

The White House has the authority to intervene in such nonbinding guidance documents — a step below enforceable regulations — at least partly because of an October 2019 executive order that tightened restrictions over the issuance of such documents. That order asserted that “agencies have sometimes used this authority inappropriately in attempts to regulate the public.” White House officials have cited it to force the Food and Drug Administration and other agencies to submit pandemic-related guidelines to the White House budget office for review before public release.

Staff members at the budget office scrutinize the documents for statements that could undercut the president’s public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.

The testing and release of a vaccine is an issue that has gained wide national attention. Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month. No clinical trial in the United States has yet advanced far enough to prove that any vaccine is safe and effective, although Pfizer, one vaccine developer, is hoping for interim results soon from its trial.

The Food and Drug Administration’s new guidelines were intended to assure companies developing vaccines that they were being held to a common standard and to reassure the public. Polls suggest that Americans are increasingly wary about taking a coronavirus vaccine: A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.

Dr. Peter Marks, the F.D.A.’s top regulator for vaccines, said last week in an event organized by Friends of Cancer Research that the government had to be transparent about the standards it was using to evaluate experimental vaccines in order to build public trust. He and other health officials have stressed that the companies developing vaccines are already fully aware of the agency’s expectations for products seeking authorization for emergency use.

Mr. Azar on Friday played down the conflict with the White House, telling a House panel that those concerned about its involvement in the guidelines were making “a mountain out of a molehill.”

“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Mr. Azar said. “The F.D.A. has already told the manufacturers what they’re going to look for.”

Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.

At a recent meeting with F.D.A. staff members, Dr. Marks said the agency “may hear more noise in the press” about trouble with the guidance but added that the “goal isn’t to get into fights,” according to people familiar with his comments. He said at the Friends of Cancer Research event that there was no reason “to get all excited” because “we are going to have a transparent advisory committee meeting for each and every emergency use authorization that comes through.”

Privately, Dr. Marks has told colleagues that an angry tweet from Mr. Trump attacking F.D.A. scientists over the guidelines could damage public confidence in a coronavirus vaccine.

The guidance laid out more specific criteria for clinical trial data and recommended that it be reviewed by the advisory committee of independent experts. It is expected to be included in the briefing papers for the committee’s next meeting, scheduled for Oct. 22.

Food and Drug Administration officials hope the committee will consider those standards before giving its blessing to any emergency use authorization for a vaccine. The most likely recipients of any vaccine that wins that authorization will be high-risk populations such as health care workers.

In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.

The guidelines also laid out the agency’s expectation that vaccine makers would continue to assess the long-term safety and efficacy of the drug, if granted emergency use authorization.

Katie Thomas contributed reporting from Chicago. Kitty Bennett contributed research.

How do you feel about a coronavirus vaccine? What do you think the guidelines will be? Will you take a coronavirus vaccine?

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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Health Fraud: FDA

Health Fraud Scams – Be Smart, Be Aware, Be Careful Video

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FDA – Health Fraud Scams
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Unfortunately health fraud scams are prevalent and many fall prey to them besides the elderly. I have personally been misdiagnosed, which included fraudulently signing my name to several medical documents and applications without my consent. Like many who are misdiagnosed to charge higher or unnecessary fees to insurance companies, medicare and medicaid, my health deteriorated to the worst condition I have ever experienced during my life. Some medical professionals will misdiagnose you based on a voting system based on no scientific evidence often handing out prescriptions to legitimize their diagnosis. The FDA is correct: these activities can and have put peoples lives in danger and have cost some their lives. Be well informed. As those who seek medical care the red flags do not always seem as obvious as you think. Undercover Epicenter Nurse: How Fraud, Negligence, and Greed Led to Unnecessary Deaths at Elmhurst Hospital reveals just how easy and how many lives have and can be lost.

What do you know about your doctor? What do you know about the history of the medical professionals and facilities that serve you? Have any reports or complaints been placed against these individuals or their facilities? 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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COVID 19 and Climate Change

COVID-19 Mitigation Leads to Reduced Pollution Associated with Decreased Fossil Fuel Use

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COVID-19 Mitigation Leads to Reduced Pollution Associated with Decreased Fossil Fuel Use
Source: NASA
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Many people have commented on the not so unusual phenomena of the planet healing itself as the world halted to a stop. In deed climate change such as extreme temperatures of heat: we have seen 102 Degrees Fahrenheit in Norfolk, VA, USA this summer (2020) alone. Extreme heat can leave people exposed to stroke and heat exhaustion landing them in the hospital. So, as one might imagine people are thrilled to see the positive change in the environment. We have definitely felt the heat and experienced the flood waters here in Norfolk, VA, USA.

We know that COVID 19 remains at the forefront of people’s minds as we wait at the edge of our seats for a cure. While you wait read COVID-19: How to Prevent Getting Infected.

What measures have you and yours taken to stay COVID 19 free? There is so much we still do not know about COVID 19. Have any of your precautions included organic or natural remedies? Do you know of anyone who has tested positive for COVID? 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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Too much and never enough!

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Pharma drew a line in the sand over Covid-19 vaccine readiness — because someone had to

By ED SILVERMAN @Pharmalot – Source: Stat News
Book Photo Source: Mary L. Trump

SEPTEMBER 7, 2020

Talk about a rebuke.

President Trump may want a Covid-19 vaccine to ship in time to boost his reelection chances, but the pharmaceutical industry doesn’t appear ready to cooperate — at least, not on his terms.

In a highly unusual turn of events, nine vaccine makers — including some of the world’s biggest companies — plan to issue their own public pledge not to seek government approval without extensive safety and effectiveness data on Tuesday. This follows a fairly similar open letter the BIO trade group released last week warning any vaccine or therapy should only become available with the same sort of “rigorously considered” data.

These are only words, but right now, these are the words that Trump needs to hear.

After Trump has brazenly and transparently bullied members of his own team — most notably, Food and Drug Administration Commissioner Stephen Hahn — someone has to draw a line in the sand and push back against him.

Get the revealing book Trump’s niece wrote about him. Trumps presidency has been far reaching as his decisions have highly impacted us all via COVID 19. Do you know who is in the Whitehouse? Hear what his niece has to say:

There’s good reason. As we move closer to Nov. 3, vaccine makers are still testing their shots. Yet at a Friday press conference, Trump said a vaccine might be ready “maybe even before Nov. 1” or “sometime in the month of October.”

The vaccine makers that are signing this pledge — Pfizer, Merck, AstraZeneca, Sanofi, GlaxoSmithKline, BioNTech, Johnson & Johnson, Moderna, and Novavax — are rushing to complete clinical trials. But only Pfizer has indicated it may have late-stage results in October, and that’s not a given.

Yet any move by the FDA to greenlight a Covid-19 vaccine without late-stage results will be interpreted as an effort to boost Trump — and rightly so.

Consider Trump’s erratic and selfish remarks. He recently accused the FDA of slowing the vaccine approval process and being part of a “deep state.” No wonder there is concern he may lean on Hahn to authorize emergency use prematurely. For his part, Hahn has insisted he won’t buckle to political pressure, but he also said emergency use may be authorized based on preliminary data.

“It’s unprecedented in my experience that industry would do something like this,” said Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “But we’ve experienced unprecedented events since the beginning of Covid-19, starting with the FDA, where the commissioner has proven to be malleable, to be kind, at the foot of the president.”

Remember, we’ve seen this movie before.

Amid criticism of his handling of the pandemic, Trump touted hydroxychloroquine, a decades-old malaria tablet, as a salve and the FDA authorized emergency use. Two weeks ago, he touted convalescent blood plasma as a medical breakthrough, but evidence of its effectiveness against the coronavirus is inconclusive. And Hahn initially overstated study results.

Most Americans seem to be catching on. A STAT-Harris poll released last week found that 78% of the public believes the vaccine approval process is driven by politics, not science. This goes for a majority of Democrats and Republicans.

Poll: Most Americans believe the Covid-19 vaccine approval process is driven by politics, not science

The pharmaceutical industry has to be vocal, though.

Why? The FDA has long been seen as the global gold standard among regulators. No government agency is perfect, but Trump is sadly undermining its credibility. If he keeps this up, it will only make it harder for companies to later point to the FDA as validation for the safety and effectiveness of their products.

This explains why the biotech executives used such pointed phrases as “FDA should maintain its historic independence” and “political considerations should be put aside.” The vaccine makers, however, avoided using any language that might appear confrontational and further provoke Trump. Instead, they underscored a need to “adhere to high scientific and ethical standards.”

Let’s be clear, though. These public pronunciations are not simply altruistic attempts to take the moral high ground. With each tweet and off-the-cuff remark about the vaccine timeline, Trump is eroding whatever confidence the public may have in vaccine makers, which is already questionable as far as some people are concerned.

“The companies are aware that, on a good day, they have trouble selling vaccines to 25% of the country that is suspicious about safety. So the last thing they need is to have Trump pull a stunt and push through a vaccine ahead of its time,” Loss said. “In many ways, the industry is doing a defensive move to ensure they’re not going to have to defend any approval because the president is doing a dance.”

The pharmaceutical industry is keenly aware that its reputation is also at stake as the pandemic becomes more and more politicized.

And simply put, that’s not good for business.

Will you vote on November 3rd? Is it important for the politicians to know you will cast a vote? Do you have questions? Contact your local office of elections. Share your comments with the community by positing 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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True to the Journey

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Moderna’s coronavirus vaccine deal with the U.S., announced last week with a $1.525 billion price tag, would be worth far more if all options are exercised—and if the mRNA biotech meets an aggressive timeline for the shot’s arrival.

The company stands to gain up to a whopping $8.125 billion, according to a Moderna securities filing that details the price for follow-up doses and the windfall for an early FDA approval.

The base agreement calls for 100 million doses of the company’s COVID-19 vaccine candidate, mRNA-1273, for $1.225 billion. But the drugmaker is eligible for a $300 million bonus if it’s able to score an FDA emergency use authorization or full approval by Jan. 31, the filing shows. 

Source: Fierce Pharma

As we get information regarding COVID 19 and on the many companies working on the vaccine, I am reminded of something my supervisor once said “the medical industry is a business like any other business”. A family friend recently shared that she tested positive for COVID 19. We prayed for her and offered her all the information we had about COVID 19. She was grateful, yet she stated that she would be seeking natural means for recovering from COVID 19. In the midst of a global pandemic it is easy to seek out the quickest solutions. She reminds us that through it all it is important to stay true to the ‘Organic Journey’. It is true in gardening and true with health. It may seem easier and quicker to grab the nearest chemical or drug for a solution. But, in our Organic Journey we have learned to first ask “what is the Organic Remedy to this problem. Who do you know that has been impacted by COVID 19? How has your family been impacted? How has your ability to work been impacted? 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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Wireless Medical Devices


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Wireless Medical Devices
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One thing we know about the FDA is that its board of medical professionals (often with unreported conflicting relations) are often too quick to push drugs and medical devices onto the market. Often they have financial incentives that encourage them to get these drugs and devices on the market fast, which is why we often see recalls. When a drug and device is not properly tested, it brings clinical trails to the unknowing public who become tests subjects. The FDA is this not proactive but reactive in dealing with things that people often spend years complaining about. Indeed these complaints are often made by thousands upon thousands of people.

The question is, should we just because we can? Are we ready for this level of technology? Do we know all the risks or are we the test subjects? Many people eat GMOs (genetically modified organisms) without knowing it. The results are still out on the impact of GMOs on the public and environment. In fact many people do not even know what GMOs are. Share your comments with the community by positing them below. Share the wealth of healthy 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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