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Ivermectin trial shows positive results, but experts still wary

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Although a top Israeli professor revealed that Ivermectin had been successfully tested on COVID-19 patients in a SA Jewish Report webinar on Thursday, 11 February, South African experts warn it’s still too early to trust this drug.

Ivermectin has been hailed by many since last year as a potential wonder drug in the fight against COVID-19. Merck, the drug’s original manufacturer, has said that too little data exists to support the use of the drug on COVID-19 patients.

In the face of mounting pressure, the SA Health Products Regulatory Authority (SAHPRA) announced last month that it had authorised a limited “compassionate and controlled-access programme” for Ivermectin to be used to treat COVID-19. Still, it stressed that only medical practitioners who applied to use the drug would be considered on a case-by-case basis, and wider access could be discussed only after large-scale testing and peer-review data became available.

The Israeli trial – like the others in South America, Bangladesh, and Egypt – was conducted in a small-scale programme.

Professor Eli Schwartz, the director of the Center for Geographic Medicine at Sheba Medical Center in Tel-Hashomer, is excited with the findings. “Ivermectin is an excellent drug that has changed many aspects of dealing with infections caused by parasites,” he says. “In many Western countries, they aren’t especially familiar with it, it’s not registered, and thus doctors are hesitant to use it.”

Schwartz shared the results of the test carried out last year for the first time on the webinar. They haven’t yet been reviewed.

“Our study looked at Ivermectin versus a placebo, using mild, non-hospitalised patients who had the virus,” he says. “Our objective was to reduce the viral shedding time and evaluate the drug’s efficacy in preventing progression.”

In a double-blind test, drug doses were determined according to the weight of each patient, and were given regularly over three days. A total of 90 patients were involved (45 in each arm of the study).

“With Ivermectin, the viral load was lowered much faster,” Schwartz says. “On day four, 57% of those who had received it were negative as opposed to 31% in the placebo group.

“From day six, more people on Ivermectin were negative, much more than in the placebo. It continued into day eight and 10. Ivermectin really had an impact, and patients quickly became negative or non-infectious.”

He also noted that some of the patients were over 60 or had risk factors, yet none of those who had taken the drug deteriorated or required hospitalisation.

Schwartz believes that the results are promising, and suggests that patients can overcome the disease faster with Ivermectin, reducing the amount of isolation required while populations wait for vaccines.

“It could prevent clinical deterioration and the need for hospitalisation,” he says. “If it proves antiviral, it can be used as a prophylactic. We should do more studies on these aspects.” He stresses, however, that the drug is no substitute for a vaccine.

Local experts and doctors are more reticent.

“The trials in other countries have been imperfect, with small numbers, varied doses, and other drugs used in addition,” says Professor Barry Schoub, the chairperson of the Ministerial Advisory Committee on COVID-19 vaccines. “We don’t really know if there’s efficacy or not, and there’s no peer-reviewed scientific evidence yet.

“It’s unlicenced, and not totally innocuous. If taken in high doses, it has the potential to be highly toxic. Unless a study is peer reviewed, it’s valueless. Until Ivermectin is tested in a proper randomised control trial, we shouldn’t use it.”

Professor Mervyn Mer, the principal specialist at Charlotte Maxeke Johannesburg Academic Hospital, says a balanced approach is needed.

“We have to question why a cheap drug hasn’t been subjected to larger trials,” he said in a recent webinar. “Many of our own colleagues are trying to take the veterinary medication, something we cannot support. A senior colleague of mine said he had taken a suggested dose and felt as strong as a horse. Several weeks later, he was severely ill with COVID-19 in intensive-care on ventilation.

“The rationale is there, but we don’t have the necessary scientific data – it’s all anecdotal. We need a balanced, sensible approach. If it works, fabulous. If not, we need to maximise what we have and continue to the best of our ability until such time as we can widely immunise patients.”

Some doctors agree with him.

“I’m not taking or prescribing Ivermectin at the moment,” says Dr Sheri Fanaroff. “It may well be effective, but the formulations currently available in South Africa aren’t regulated and thus not reliable or safe.

“If I prescribed Ivermectin and my patient developed a neurological side effect, I wouldn’t have any legal defence.”

“The Israeli study didn’t use people who are hospitalised or patients with severe disease,” says pulmonologist Anton Meyberg. “In our hospital, we had eight patients that started with mild disease, all took Ivermectin in high doses, and they all demised. They all had pulmonary and neurological manifestations, and were extremely ill.

“We have to be very careful with these small studies,” Meyberg says. “When a study is done on 90 people, that’s a phase-one trial. You need a few thousand people to see the effects of the drug. Even in Israel, Ivermectin isn’t part of the arsenal of medication and isn’t being used to treat COVID-19.”

However, GP Dr Paul Freinkel argues that there’s little downside to using the drug, and probable benefit.

“If it doesn’t work, we’ve lost little other than hope,” he says. “If it does, we’ve saved a life and, in some cases, a lifetime of disability.”

Freinkel recognises that the data generated so far by smaller trials is incomplete but maintains that very few trials show that Ivermectin doesn’t work, and they are generally underdosed.

“Even though there are no large-scale trials, what’s the chance of all the trials [of adequate dosing] all showing a benefit to using Ivermectin?” he asks.

“Andrew Hill, a senior researcher at Liverpool University, reports that the chance of an error in his meta-analysis [of the trial studies] is one in 5 000. In other words, the chance of his assertion that Ivermectin appears to work when in fact it doesn’t is only one in 5 000. That’s a one in 5 000 chance that it doesn’t decrease the chance of people dying,” Freinkel says.

“As my patients get sicker, I wonder about the downside to using it versus the 4 999 in 5 000 chance that it has a benefit. Must I watch a patient die knowing there is so little downside of her taking a drug that may cure her? The law says so.”

Because recommending Ivermectin carries the risk of prosecution, Freinkel suggests that Ivermectin should be approved for human use on parasites, where the efficacy and safety data are incontrovertible.

“This would allow doctors to legally and ethically use the medication off-label, as they do in most other countries,” he says.

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Vaccination a jab of hope for healthcare workers

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After a sleepless night marked by a mix of anxiety and excitement, Dr Mark Kadish woke up on Tuesday morning, 23 February, ready for a historic occasion: his long-awaited vaccine against COVID-19.

“I woke up on an emotional rollercoaster,” the GP told the SA Jewish Report. “I sat with my wife and reminisced about this past year of the COVID-19 pandemic, and how it had been working in healthcare. All healthcare workers and their support staff are mentally, physically, and emotionally depleted. As I entered the vaccination environment, I was overwhelmed with emotion.”

Kadish is one of thousands of South African healthcare workers who have at last received their shot of the Johnson & Johnson vaccine in recent days. The first leg of South Africa’s vaccine rollout programme is well underway, and in spite of some complications and frustrations, almost 40 000 healthcare workers across the country were expected to be inoculated by Wednesday, 24 February.

“I feel grateful and blessed to have received the vaccination,” says Kadish. “I feel privileged and at the same time so excited to be able to hug my family again. Driving back to my practice from my vaccine, I can honestly say I felt more hopeful and optimistic.”

The sense of relief amongst several doctors is especially significant following the frustration which beset the rollout previously. In the wake of the cancellation of the AstraZeneca vaccine rollout, many doctors were again disappointed on Sunday, when they were unable to receive their shots at Chris Hani Baragwanath Hospital.

“A number of GPs had registered for their vaccine and went on Sunday, only to be told Baragwanath wouldn’t be running because it was a weekend,” says pulmonologist Dr Anton Meyberg, who had booked for this vaccination slot. “A lot of them then went to Steve Biko Academic Hospital, and it was absolute chaos.

“More than 2 000 people were there, with queues on top of each other. They don’t have the facilities for people to be there, and people were being told to leave. It was a feeding frenzy.”

Thanks to the efforts of Netcare, however, Meyberg was able to secure a second booking for Tuesday, going to Baragwanath Hospital with fellow specialist Dr Carron Zinman.

“I was pleasantly surprised,” says Zinman. “The process was organised and efficient, with healthcare workers standing in designated queues with strict distancing. I joined the Netcare queue, presented my ID and booking number, and completed some forms. It felt like I was back at school.”

Carefully spaced groups of vaccinees were ushered into a hall and positioned at individual stations, greeted by a nurse ready to administer the vaccine.

Zinman recounts, “Bara had drawn up individual doses. There was a syringe with your name and number on it waiting, and after you got it, they waited to see if you had any immediate reaction. Women burst into song and clapped as we stepped outside to be monitored for anaphylactic reaction. It was a beautiful moment.”

Though the vaccine won’t change her social distancing habits or wearing of personal protective equipment, Zinman says it offers some relief and hope.

“I’m happy it’s done,” she says. “We’re still seeing positive patients, and though we’re wearing our equipment, you have a feeling that maybe the vaccine adds another layer of protection.”

Meyberg was equally elated.

“Fighting COVID-19 means working hard, putting life on hold, and risking your family,” he says. “The vaccine felt like getting some hakarat hatov [gratitude], something to say that people appreciate the risks you and your family take daily.”

Other healthcare workers in the Jewish community had equally moving experiences, in spite of many initially being let down by events on Sunday.

“I was as nervous about driving to Bara as I was about getting the vaccination,” admits GP Dr Lana Marcus. “I hadn’t been there since 2006. There was a lot of anxiety about logistics and parking, and obviously about the vaccine.

“I had an idea of what to expect based on photos shared by other GPs, and I was really impressed with the setup. It was smooth, there was no crowding, it was well-explained, and the staff were friendly.

“I now no longer have the holy terror of catching COVID-19.”

Dr Monique Price, the Chevrah Kadisha’s senior medical doctor, described her vaccination as an out-of-body experience.

“My rescheduled appointment was at 15:20 on Monday, and within a few minutes, I was in the observation area,” she says.

“When I had it, I felt on a high and part of something momentous and positive. Only two weeks ago, we weren’t sure any of us would get it when the AstraZeneca vaccine was cancelled.”

If the successful rollout so far shows how things can be done at a public tertiary hospital, Price feels that the rest of the country can surely follow suit and everyone can be vaccinated.

“13 March marks a year since the Chevrah Kadisha closed the doors to its facilities,” she says. “I would love to open them again, but that can happen only when it’s safe. It’s still some way off, but this is possibly the beginning of a positive change.”

After some initial scepticism, GP Dr Daniel Israel says his vaccination this week offered some much-needed light at the end of a long tunnel.

“There was some concern about GPs because they don’t fit into either public or private healthcare systems,” he says. “They’re on the frontline, so it’s important they get their shots, too.

“I had the attitude that I would believe it only when I saw the needle in my arm. When I saw all the incredible work being done by volunteers at Bara, however, I was reminded of the election in 1994 and felt that people were coming together and uniting for a common, important goal. People pulled together and made it happen.”

Doctors being vaccinated is a beacon of light, Israel says. “Time will tell if the vaccine is fully effective, but it’s a wonderful thing, and I feel a little safer.”

Dr Gilad Mensky, who works in intensive-care at Baragwanath Hospital, paid tribute to the efforts of the hospital and all volunteers involved. He was vaccinated last week.

“Bara has done an outstanding job,” he says. “You really felt safe. Heads of department and senior doctors were on the floor ushering people and helping them. You felt the commitment and the enthusiasm.

“We’ve all gone through an emotional derailment, and it was nice to get some upliftment at last. A vaccine isn’t a right but a privilege, and I’m honoured to have received it.”

Says Meyberg, “We will still wear our masks and maintain protocols as we wait for herd immunity as more people get vaccinated. People need to understand that more vaccines are on the way, and that everyone will get it. There’s a lot of work going on behind the scenes, and we are seeing the results.”

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SA chiropractor in Melbourne jail pleads guilty to drug trafficking

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A former head boy of King David Victory Park (KDVP) has pleaded guilty to importing a large quantity of cocaine from South Africa to Australia in 2018.

Dr Warren Sipser, 44, a prominent Melbourne chiropractor, previously married to television personality and author Andi Lew, has been in jail since December 2018. He recently pleaded guilty in the County Court of Victoria to importing a commercial quantity of cocaine with an estimated street value of A$90 million (R1 billion).

Australian police say that 120kg of liquid cocaine was shipped from South Africa in 600 wine bottles ordered on eBay. Police discovered the bottles containing the illegal substance, and an elaborate plan was devised to follow the drug trail which lead them to Sipser’s Elwood clinic in July 2018.

Sipser was previously denied bail in the criminal division of the Supreme Court in Melbourne in 2019.

His worried mother, who lived with her son in Melbourne at the time of his arrest, has been told by her son’s lawyers not to comment. She remains in regular contact with her son and grandson, Sipser’s 11-year-old son.

Sipser’s father, who asked not to be named, lives in Johannesburg. He hasn’t had much contact with his son since he left the country 22 years ago, but said the matter was taking its toll. He told the SA Jewish Report this week that he believed his son was “possibly set up”.

“I don’t believe my son is a drug dealer,” he said.

While Sipser sat in his high security jail cell this week, his troubled parents communicated via WhatsApp, marking the yahrzeit of his sister and their daughter, Stacey, who died 35 years ago from cancer.

“There isn’t a day we don’t think of her,” said Sipser’s father, 78, who continues to hope that one day, he will be reunited with his son and meet his grandson for the first time “when all this is over”.

Being so far away and suffering from several co-morbidities, Sipser’s father is doubtful that will happen soon, if ever.

“I feel so helpless. He’s there, I’m here, we’re all helpless. We can do nothing, it is all in Hashem’s hands,” he said.

“I told my ex-wife to wish him happy birthday earlier this month, and send him all my love. Warren is in the prime of his life, what can I say,” he lamented.

For now, his parents can only hope that their son will be given a light sentence after having already spent 26 months in jail awaiting trial.

The Herald Sun reported last week that Sipser will be sentenced later this year on one charge of attempting to import a commercial quantity of a border-controlled drug, and one charge of possessing a controlled drug.

At his 2019 bail hearing, prosecutors said Sipser allegedly bought a consignment of wine through eBay on 23 June 2018. When it arrived in Sydney, addressed to Sipser, it came with supporting documents which predated the purchase date.

The consignment was inspected by the Australian Border Force (ABF), and the contents of one of the bottles tested “a positive presumptive test for cocaine”. The consignment was seized by the ABF, and the matter referred to the Australian Federal Police (AFP) for investigation.

The AFP office in Sydney retained the original consignment, and forwarded the packaging to the AFP in Melbourne. Subsequent testing allegedly identified traces of cocaine in 343 out of the 600 bottles in the consignment, according to court documents.

The prosecution said agents then replaced the original consignment with replica bottles containing an inert substitute, and let the shipment continue under surveillance.

The bottles were delivered to Sipser’s Elwood clinic while he was at Crown Casino in what police suspected was an attempt to distance himself when they arrived.

The cargo was then collected by two men, who were arrested in a highway intercept at Tallarook, north of Melbourne, and later released without charge.

Three months later, an undercover police officer allegedly made contact with Sipser and made “an offer to alter or destroy documentation connecting the applicant [Sipser] to the consignment”, according to court papers. Sipser allegedly accepted the offer.

Sipser, who has no criminal convictions, was arrested in December 2018 at his Ormond Road clinic.

Police searched Sipser’s home and practice. The bail hearing was told items found included clip-seal bags, empty capsules, scales, 79.3g of cocaine, and A$2 100 (R30 709) in currency. A search of his vehicle was also conducted, which allegedly found capsules, and A$650 (R9 505) in currency.

Sipser was headboy of KDVP in 1994, and played first team rugby. After Grade 12, he trained as a paramedic in South Africa, then graduated as a chiropractor from RMIT University in Melbourne. He has a Masters in paediatric chiropractic. He opened his popular chiropractic practice at the age of 25. He made a name for himself as a primary care provider and health and wellness professional, with children making up a large percentage of his business. He served on the executive of the Chiropractors Association of Australia for many years.

He and Lew described themselves as wellness experts, and co-authored a book: 7 Things Your Doctor Forgot To Tell You, as a guide to optimal health. The couple, who divorced several years ago, have a son together.

Sipser’s chiropractic business has been sold since his arrest, and his license to practice has been suspended by the Australian Health Practitioner Regulation Agency.

People have been known to plead guilty, even when they are innocent, often in exchange for a reduced sentence, rather than risk a guilty verdict at trial that would come with more severe punishment.

It’s not known when Sipser will appear for sentencing.

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SA expats face ‘apocalypse now’ in Texas

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South African Jewish expatriates in Texas, United States, have experienced isolation, outages, and chaos on a scale that they never expected when they made the move to America, after the state was hit by an unprecedented snowstorm from 10 to 17 February, causing a humanitarian crisis.

“It felt apocalyptic. If we’d had any warning we would have prepared, but there was no inkling that we would be in such a crazy situation,” says Deborah Barak, who is in Houston with her partner and one-year-old daughter. “We had no power, water, or heat from Sunday 02:00 [14 February] to Wednesday night [17 February], aside from a couple of hours on Monday morning. To keep warm, we stayed in the smallest room in the house with all the blankets we could find.

“Luckily, we had gas to cook with and had recently been shopping, so we ate well, but we had no water to clean with or flush toilets. After a few days, the dirt started to pile up. I dressed my daughter in layers and tried to keep her under blankets, but she’s pretty mobile and got frustrated that we wouldn’t let her out of the room.

“There was absolutely nothing open around us, and very little information about what was going on. We were truly isolated. Occasionally, we would go for a careful drive to warm up in the car and charge our phones, but we kept those to a minimum because we had only a little petrol and there was none to be found anywhere. Luckily, we had a case of water, because we couldn’t find any. After several attempts, we found some diapers. We were down to just three when we found some.

“We got our power and heat back on Wednesday, but it took several more days before we had drinkable water. Everything is back to normal now, and it’s hard to believe that we felt so helpless about keeping our child safe and warm. It’s quite shocking how easily you can suddenly be cut off from the rest of the world.”

Trevor Kobrin lives in an apartment block in Irving, near Dallas. He was hit by rolling blackouts for three days, with only intermittent power coming on unexpectedly for half an hour, often in the middle of the night. At one point he was so cold, he warmed a cup of soup with heat from candles, and tried to make a cup of tea by boiling water on the stove. Soon after his electricity returned, he found he had no water in his taps. “Almost a week later, I still have no water,” he told the SA Jewish Report just hours before his water did return.

“I was able to go to a friend to shower and I had enough to drink, but needed water for washing dishes, flushing toilets, and so on. On Thursday night [18 February], I was so desperate, I went out to collect snow and melted it. The snow has since melted, and I was able to buy water, but you are only allowed to buy two five-litre bottles a day at the moment. On Sunday [21 February], I went to the complex swimming pool to try to get some water. It was all iced up, but I found a corner where the ice had melted, and I took from there.” Kobrin says he was in Cape Town at the height of its drought crisis, and what he learnt then helped him in this situation.

Says Linda Behr, “My husband and I left South Africa on a beautiful day in January 1977 and believe it or not, arrived in Dallas, Texas during an ice storm. Since then, we have had similar ice storms every couple of years. None of those winter storms prepared us for the one we just had!”

On Thursday morning, 11 February, she says, “I was due to go get my second COVID-19 vaccine. At 10:00 I received a call that my appointment was cancelled – the distributors were unable to get the vaccines out because of icy roads.

“On Saturday, I managed to get to the grocery store, which was packed. We were told that temperatures on Monday could reach -15 C. In the 44 years that we have lived here, we had never heard of Texas experiencing such low levels. We woke up on Monday morning to -13 C. Our power had gone off in the middle of the night, and it was freezing!

“We heard we were going to be having rolling blackouts. The power was supposed to be off for 15 to 45 minutes then go on again, but the people working these rollouts had no idea how to manage it properly. So the power would come on for anywhere from one to four hours, then go off for about seven to nine hours.

“One thing saved us. We have a gas fireplace, so we huddled there to defrost! My daughter, Tracy, and her boyfriend, Moshe, were staying with us. Moshe got very creative. He took one of my pots with a long handle, filled it with water, and boiled the water over the fire. He also made toast and scrambled eggs over the fire.

“For two days, the power was more off than on. Many people had burst water pipes, some died because of the extreme cold, and other weather-related problems have caused billions of dollars of damage in what may become Texas’s most expensive natural disaster in history.”

Joan Gremont in Dallas says, “On Friday night during our family Shabbat Zoom, our son in Austin mentioned that they had been without power for more than 24 hours. I told them they should come to Dallas. Austin had precipitation which had turned to ice, but Dallas didn’t have – yet. He agreed, and at 21:00, they packed up the kids, food, and two dogs, and were on the road, a 200-mile (322km) trip, arriving at midnight.”

Her son, Evan Gremont, says they looked “like refugees after packing up the house in complete darkness”. Ironically, the power returned to his house one hour after he left, and didn’t go off again. However, since returning to Austin a few days later, he has had to boil water to drink, and people have had to queue for water.

“It was cold, but we had power,” says his mother. “It got colder, and on Monday, our power went off and on without any warning. We left a lamp on in the living room. This was our signal that it was on or off as we sat in front of the raging fire in the gas fireplace.

“When there was no heat late on Monday afternoon, we all packed up and went to a friend, who lives in a spacious house not even a mile away from us, but they never lost power. There were 14 of us in their house, plus three dogs!

“The next day, we came home after we were able to determine that our power was back on. The pool iced over. In our 42 years in Dallas, we had never seen anything like this. I put the kettle on so we could have our Five Roses tea – first priority! That night, the power was out again so we went back to our friends, and returned home on Wednesday morning. We were much better off than tens of thousands of others,” she says.

Gremont says many organisations offered assistance, for example, one of their local kosher restaurants made free, hot kosher meals to distribute to anyone who needed it.

“The only reason we were able to drive on the snow-covered roads is that our son drives a four-wheel-drive truck. Neighbourhood roads were never cleared of the snow. Texas doesn’t have the equipment or manpower for this.”

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