Agrees

medicine

Former Barrie surgeon agrees not to practise medicine again, anywhere

A former Barrie surgeon has given up his licence to practise medicine and has promised his regulatory body to never apply to register as a physician ever again, anywhere.

The agreement arose following a College of Physicians and Surgeons of Ontario (CPSO) disciplinary hearing last week.

“The agreement to never reapply for registration… is the maximum level of punishment available in this situation,” said CPSO communications advisor Josh McLarnon.

The college had earlier launched investigations into Dr. Emad M. Guirguis and his now-defunct Lakeview Surgery Centre on Dunlop Street following complaints.

He was found to perform cosmetic surgery that was outside his scope of practice as a physician, not having the proper training and certification.

He also engaged in unprofessional conduct through online advertising and communications with a specific patient.

In addition to the practice ban, he was ordered to pay $6,000.

“Dr. Guirguis has been brought forward to the discipline committee on a number of occasions,” McLarnon added.

An investigation was first launched in 2015 resulting in a caution three years later.

Another caution was later issued relating to his compliance of the first issue.

In one complaint, Guirguis tried to perform bariatric revision gastric band surgery, but decided not to complete the surgery because he encountered extensive scar tissue from previous surgeries. According to documents from the college’s compliance and monitoring department, he perforated the patient’s bowel during the surgery, resulting in ongoing complications.

The complainant said he did not communicate or follow up with her after the surgery or provide a refund of her fee.

“The committee… was of the view that the respondent’s pre-operative assessment was insufficient,” the decision of the inquiries, complaints and reports committee found.

In another report, an independent assessor concluded: “Dr. Guirguis did not meet the standard of practice of the profession in some of the cases reviewed; his knowledge was adequate but basic; his surgical skills were adequate for his limited scope of practice; his judgment was not always adequate, mostly because the brief documentation does not allow a full understanding of his train of thought and exposes omissions or incomplete assessments; and in the reviewed cases his clinical practice, behaviour, or conduct had the potential to expose one patient to harm.”

Other assessors, it added, found broad deficiencies in Dr. Guirguis’s practice.

In a report from Dec. 14, 2018, Guirguis was cautioned about not providing a full explanation of a procedure to a patient and ensuring the patient had full clarity about what was going to be done following a complaint to the college about the outcome of a cosmetic surgical procedure.

According to CPSO documents, Guirguis agreed he has engaged in an act or omission relevant to the practice of medicine that would reasonably be regarded by members as disgraceful, dishonourable or unprofessional.

He was ultimately found to have committed an act of professional misconduct.

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Dr. Guirguis’s certificate of registration expired Sept. 4, 2020.

In addition to the clinic, Guirguis was also once

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health

Trump administration agrees to purchase $375 million of Lilly coronavirus antibody drug

The Trump administration will pay Eli Lilly $375 million to supply 300,000 doses of its experimental antibody drug to treat COVID-19, the Department of Health and Human Services said Wednesday.

If the Food and Drug Administration authorizes use of the drug, the federal government will allocate the doses to state and territorial health departments which, in turn, will determine which health care facilities receive the drug for use in outpatient care.

Lilly said it anticipates only high-risk patients will be indicated to receive the drug until more studies are completed and more supply is available.

The initial agreement is for delivery over the course of two months following authorization, with the option to purchase up to 650,000 additional doses through the end of June 2021 for up to an additional $812.5 million. 

The government-purchased doses would become available to Americans at no cost, although health care professionals could charge for administering the medicine.

Eli Lilly’s CEO, David Ricks, said the company is allocating the drugs to the countries that need them most, and will commit only to a few months of supply at a time to any given country in order to match demand with the limited supply.

“Unfortunately, the U.S. now leads the world in both COVID-19 cases and deaths. As a result, a top priority is helping reduce disease burden in the U.S.,” Ricks said. 

The rolling, seven-day average of daily cases in the U.S. topped 70,000, according to the COVID Tracking project data. With that many cases a day, the projected supply of the monoclonal antibodies would not be nearly sufficient to meet demand.

Lilly said it anticipates manufacturing up to 1 million doses of its drug by the end of 2020, with 100,000 doses ready to ship within days of authorization.

The agreement with Lilly is part of the administration’s Operation Warp Speed, the initiative created by the administration to fund the quick development and distribution of a COVID-19 vaccine.

Ricks said Lilly is pricing the drug at $1,250 per vial in wealthy countries, with a tiered system based on the country’s ability to pay. One vial represents the full course of treatment.

Ricks said the company expects to make a profit, and is pricing the drug “above our marginal cost to produce the medicine in developed markets,” meaning it expects “to produce a modest financial return for our investors by the end of 2021.”

The announcement of the agreement comes a day after Lilly said the drug had no clinical benefit for helping hospitalized patients. The company said it is confident the drug is helpful to those earlier in the course of a COVID-19 infection.

Antibody drugs are experimental, and while doctors think they promise as a potential treatment of COVID-19 and could be a bridge to a vaccine, clinical studies are still ongoing.

But President TrumpDonald John TrumpGiuliani goes off on Fox Business host after she compares him to Christopher Steele Trump looks to shore up support in Nebraska NYT: Trump had

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health

As Purdue Pharma Agrees to Settle with the DOJ, Revisit Its Role in the Opioid Crisis | Opioids, Inc. | FRONTLINE | PBS

In the latest chapter of a complex legal battle over who is responsible for the nation’s opioid crisis, Purdue Pharma, the manufacturer of the notorious painkiller OxyContin, has arrived at an $8.3 billion settlement with the federal government, pending court approval.

Announced in an Oct. 21 Department of Justice press conference, the settlement, if approved, resolves the federal government’s civil and criminal probes into Purdue Pharma, which is currently in bankruptcy; an additional settlement resolves a federal civil case against Purdue Pharma’s owners, the Sackler family.

“It’s also important to note that this resolution does not prohibit future criminal or civil penalties against Purdue Pharma’s executives or employees,” Jeffrey A. Rosen, the U.S. deputy attorney general, said at the press conference.

Under the settlement, Purdue Pharma admits guilt on three felony charges involving conspiring to defraud the U.S. and break anti-kickback regulations in how it marketed opioids. The settlement involves a $3.5 billion criminal fine and a $2 billion criminal forfeiture, as well as a civil payment of $2.8 billion, though actual monetary payments could be substantially less, once the company’s value is factored in. Separately, the Sacklers themselves will make a $225 million payment to the U.S.

The settlement “will require that the company be dissolved and no longer exist in its present form,” Rosen said, with the Sacklers barred from any controlling or owning role moving forward. Instead, if the settlement is approved by bankruptcy court, the company’s assets would become “owned by a trust for the benefit of the American public,” Rosen said. The new company would still be able to manufacture opioid drugs but would also be required to produce large quantities of medicines to treat and respond to addiction and overdoses, and would need to offer the latter as donations or “at cost.”

“Purdue deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice in the agreed statement of facts,” Steve Miller, chairman of Purdue Pharma’s board, said in a statement.

In a separate statement, Sackler family members who served on the Purdue Pharma board said they had “acted ethically and lawfully” and that they “reached today’s agreement in order to facilitate a global resolution that directs substantial funding to communities in need, rather than to years of legal proceedings.”

The statement also said, “Regarding the plea agreement between the government and Purdue, no member of the Sackler family was involved in that conduct or served in a management role at Purdue during that time period.”

A number of states’ attorneys general spoke out against the terms of the proposed settlement as inadequate and vowed to continue to pursue cases against the company and the Sacklers, which the federal settlements do not resolve.

Purdue Pharma has long been accused of being a driver of America’s opioid crisis. FRONTLINE’s 2016 documentary Chasing Heroin investigated how that crisis came to be, examining allegations about Purdue Pharma’s role in the early years of what has been called the worst drug epidemic in U.S. history.

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