Posted on October 13, 2020 by [email protected]_84
CHESAPEAKE, Va. — The last time Brittni DuPuy-German saw her trusted gynecologist, she once again explained that the stabbing, mystery pain in her abdomen had not gone away.
It first appeared two years earlier, after she said her doctor, Javaid Perwaiz, surgically tied her tubes. To fix it, he had proposed more surgery — three additional procedures in nine months that she said included a hysterectomy when she was 29. But the pain persisted.
So on Nov. 8, 2019, at his private-practice office, Perwaiz and DuPuy-German discussed the possibility of yet another surgery, she said. He scheduled an ultrasound for just days later, a sign of the efficiency that DuPuy-German had come to expect from her family’s longtime gynecologist. He was her mother’s doctor, her sister-in-law’s doctor, her best friend’s doctor. Perwaiz had delivered DuPuy-German and delivered her children.
Which is why, when her phone buzzed the day after her appointment, she was shocked by the headline she was reading: “Chesapeake doctor tied women’s tubes, performed hysterectomies without their consent, feds say.”
She absorbed the details of the FBI investigation. Her doctor, the news report said, was accused of lying to patients and persuading them to have life-altering surgeries they didn’t need. DuPuy-German began doubting everything Perwaiz had told her about her own body.
“That’s when all of the things that I didn’t question before started popping up,” she said.
As Perwaiz faces trial this week, a year after his arrest, DuPuy-German has received few answers to those questions — even as the FBI’s investigation expanded and the list of alleged victims grew. There are 29 patients specified in court documents and hundreds of others who contacted authorities after the doctor’s arrest.
DuPuy-German, now 32, is not cited in the criminal case but has filed a lawsuit against Perwaiz.
The U.S. attorney’s office for the Eastern District of Virginia would not say how many women in total were allegedly mistreated by Perwaiz, but in a recent trial memorandum prosecutors wrote that “the identified patients are only ‘examples’ of the scheme to defraud.”
The case, which authorities said was launched in 2018 after a hospital employee’s tip, first hinged on one charge each of health-care fraud and false statements. Federal prosecutors now allege that Perwaiz executed an “extensive scheme” spanning nearly a decade that endangered women’s pregnancies, robbed their ability to conceive and pressured them into unnecessary procedures based on unfounded cancer diagnoses and exams using broken equipment.
The more procedures Perwaiz performed, authorities said, the more money he made off insurance companies. He used the profits, according to prosecutors’ trial memorandum, “to support his lavish lifestyle.”
Perwaiz, who is jailed without bond, pleaded not guilty. He has not spoken publicly about the allegations but defense attorneys said in a court document he is “prepared to defend himself at trial.” His lawyers in the criminal case have not responded to multiple requests for comment, but have argued unsuccessfully in numerous motions to dismiss that, among other things, some charges were duplicative.
Tag: trial
Eli Lilly antibody trial paused over safety concerns
Posted on October 14, 2020 by [email protected]_84
Checking in: The trial design calls for the data and safety monitoring board to examine results from the first 300 participants — including their need for supplemental oxygen, mechanical ventilation or other supportive care five days after receiving the treatment or a placebo — before proceeding with further enrollment.
The NIAID trial has so far enrolled 326 patients. An agency spokesperson said that the board overseeing the trial this morning “reached a predefined boundary for safety at day five.” The board will now decide whether the trial should add 700 more participants.
The NIAID spokesperson added that the pause in enrollment is “out of an abundance of caution” and the safety board is “continuing data collection and follow-up of current participants for safety and efficacy.”
The late-stage study is examining whether Lilly’s antibody, known as bamlanivimab, could help hospitalized patients. The treatment is a monoclonal antibody that mimics the antibodies the body makes naturally. It’s similar to the Regeneron antibody cocktail that President Donald Trump received recently after being diagnosed with Covid-19.
Background: Last week, Lilly asked the FDA to grant an emergency-use authorization that would allow use of the antibody treatment in high-risk patients recently diagnosed with mild-to-moderate Covid-19.
That application is largely based on preliminary data from a Phase II trial released in mid-September that showed patients who received any dose of the antibody were less likely to be hospitalized or visit the ER.
What’s next: The data and safety monitoring board overseeing the trial will review data again at a preplanned meeting on October 26. The board will recommend at that meeting whether or not enrollment should be resumed, according to NIAID.
Source Article …
Category: health Tags: antibody, concerns, Eli, Lilly, paused, safety, trial
As Dr. Javaid Perwaiz faces trial, the women he treated question decades of care
Posted on October 13, 2020 by [email protected]_84
CHESAPEAKE, Va. — The last time Brittni DuPuy-German saw her trusted gynecologist, she once again explained that the stabbing, mystery pain in her abdomen had not gone away.
It first appeared two years earlier, after she said her doctor, Javaid Perwaiz, surgically tied her tubes. To fix it, he had proposed more surgery — three additional procedures in nine months that she said included a hysterectomy when she was 29. But the pain persisted.
So on Nov. 8, 2019, at his private-practice office, Perwaiz and DuPuy-German discussed the possibility of yet another surgery, she said. He scheduled an ultrasound for just days later, a sign of the efficiency that DuPuy-German had come to expect from her family’s longtime gynecologist. He was her mother’s doctor, her sister-in-law’s doctor, her best friend’s doctor. Perwaiz had delivered DuPuy-German and delivered her children.
Which is why, when her phone buzzed the day after her appointment, she was shocked by the headline she was reading: “Chesapeake doctor tied women’s tubes, performed hysterectomies without their consent, feds say.”
She absorbed the details of the FBI investigation. Her doctor, the news report said, was accused of lying to patients and persuading them to have life-altering surgeries they didn’t need. DuPuy-German began doubting everything Perwaiz had told her about her own body.
“That’s when all of the things that I didn’t question before started popping up,” she said.
As Perwaiz faces trial this week, a year after his arrest, DuPuy-German has received few answers to those questions — even as the FBI’s investigation expanded and the list of alleged victims grew. There are 29 patients specified in court documents and hundreds of others who contacted authorities after the doctor’s arrest.
DuPuy-German, now 32, is not cited in the criminal case but has filed a lawsuit against Perwaiz.
The U.S. attorney’s office for the Eastern District of Virginia would not say how many women in total were allegedly mistreated by Perwaiz, but in a recent trial memorandum prosecutors wrote that “the identified patients are only ‘examples’ of the scheme to defraud.”
The case, which authorities said was launched in 2018 after a hospital employee’s tip, first hinged on one charge each of health-care fraud and false statements. Federal prosecutors now allege that Perwaiz executed an “extensive scheme” spanning nearly a decade that endangered women’s pregnancies, robbed their ability to conceive and pressured them into unnecessary procedures based on unfounded cancer diagnoses and exams using broken equipment.
The more procedures Perwaiz performed, authorities said, the more money he made off insurance companies. He used the profits, according to prosecutors’ trial memorandum, “to support his lavish lifestyle.”
Perwaiz, who is jailed without bond, pleaded not guilty. He has not spoken publicly about the allegations but defense attorneys said in a court document he is “prepared to defend himself at trial.” His lawyers in the criminal case have not responded to multiple requests for comment, but have argued unsuccessfully in numerous motions to dismiss that, among other things, some charges were duplicative.
Category: health Tags: Care, decades, faces, Javaid, Perwaiz, question, treated, trial, women
J&J says review of illness that led to pause of coronavirus vaccine trial could take days
Posted on October 13, 2020 by [email protected]_84
(Reuters) – Johnson & Johnson said on Tuesday it would take a few days at least to hear from a safety monitoring panel about its review of the company’s late-stage COVID-19 vaccine trial after announcing that the large study had been paused due to an unexplained illness in one participant.
The pause comes around a month after AstraZeneca Plc also suspended trials of its experimental coronavirus vaccine – which uses a similar technology – due to a participant falling ill. That trial remains on pause.
U.S.-based J&J, whose vaccine effort is among the high profile attempts to fight the coronavirus pandemic, said on Monday the illness was being reviewed by an independent data and safety monitoring board as well as its own clinical and safety team. The data board is then required to submit its findings to the U.S. Food and Drug administration before the study can be restarted.
Mathai Mammen, head of research & development at J&J’s drugs business, said the company informed the safety board about the ill trial participant on Sunday. The board has asked for more information, he said, adding that the company is collecting information to answer its questions.
“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.
He said because the study is blinded, the company did not yet know if the ill person had been given the vaccine or a placebo.
J&J said such pauses are normal in big trials, which can include tens of thousands of people. The company said the trial is still on track to continue adding patients over the coming months.
It noted that the voluntary “study pause” in giving doses of the vaccine candidate to trial participants was different from a “regulatory hold” imposed by health authorities.
Former FDA chief said on Twitter the trial said that the oversight of safety boards for the COVID-19 vaccine trials is evidence of the “integrity, rigor, and careful nature” of the vaccine trial process.
Experts and officials have voiced concerns that U.S. President Donald Trump could put pressure on vaccine makers to rush an unsafe or ineffective vaccine to market.
AstraZeneca last month paused late-stage trials of its experimental coronavirus vaccine developed with the University of Oxford due to a serious unexplained illness in a British study participant.
While AstraZeneca’s trials in Britain, Brazil, South Africa and India have since resumed, its U.S. trial is still on hold, pending a regulatory review.
The J&J and AstraZeneca vaccines both use modified, harmless versions of adenoviruses to deliver genetic instructions to human cells in order to spur an immune response to the target virus, in this case the novel coronavirus.
They are both also
Category: health Tags: coronavirus, days, illness, led, pause, review, trial, vaccine
Dustin Johnson; Johnson & Johnson vaccine trial
Posted on October 13, 2020 by [email protected]_84
Since the coronavirus pandemic started, the United States has recorded more than 7.6 million cases of COVID-19 and 213,000 deaths.
USA TODAY
A third of U.S. states are reporting higher coronavirus case counts than they’ve ever had before.
A USA TODAY analysis of Johns Hopkins data shows 16 states set records for new cases in a week. But nearly all states are surging: 41 states had worse weeks than they did a week earlier. And an analysis of COVID Tracking Project data shows that in 36 states, a higher rate of people were testing positive than in the week before.
While the data continues to show the virus’ reach is not letting up, the head of the World Health Organization said achieving herd immunity by allowing the virus to spread is “scientifically and ethically problematic.”
“Herd immunity is achieved by protecting people from a virus, not by exposing them to it,” WHO Director-General Tedros Ghebreyesus said Monday, adding that the strategy relies on vaccination.
The quest for a vaccine, however, ran into trouble on Monday when Johnson & Johnson paused its Phase 3 clinical trial because of a participant’s unexplained illness. It’s the second of four large-scale, final-stage vaccine trials to go on hold as President Donald Trump pushes for a vaccine by Election Day on Nov. 3. Eli Lilly paused an antibody trial on Tuesday because of safety concerns.
Some significant developments:
📈 Today’s numbers: The U.S. has reported more than 7.8 million cases and 215,000 deaths, according to Johns Hopkins data. There have been more than 37.8 million confirmed cases around the world and 1 million deaths.
🗺️ Mapping coronavirus: Track the U.S. outbreak, state by state.
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World’s top golfer Dustin Johnson has positive COVID-19 test
World No. 1 golfer Dustin Johnson withdrew Tuesday from an upcoming golf tournament in Las Vegas after testing positive for COVID-19.
According to
Category: health Tags: Dustin, Johnson, trial, vaccine
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