Silicone breast implants up risk of stillbirth, cancer

Agencies
September 18, 2018

Houston, Sept 18: Silicone breast implants may increase the likelihood of stillbirth by over four times, and put women at higher risk of developing cancer and several rare disorders, a study warns.

The elevated risks included three conditions classified as autoimmune or rheumatologic disorders: Sjogren's syndrome, with a risk about eight times higher than in the general population; scleroderma, a seven-fold increase in risk; and rheumatoid arthritis, about a six-fold increase in risk.

"We are reporting an analysis of the largest prospective study to date on silicone breast implant safety," said Mark W Clemens, from the University of Texas in the US.

"This data gives women important safety information about silicone breast implants to have real expectations and to help them choose what is right for them," said Clemens.

In 2006, the US Food and Drug Administration approved silicone gel-filled implants from two manufacturers, stipulating that the manufacturers conduct large postapproval studies (LPAS) to monitor long-term health and safety outcomes.

"Despite abundant data collection, and open public access, the LPAS database had not yet been analysed and reported," said Clemens.

The researchers analysed data on nearly 100,000 patients enrolled in the LPAS between 2007 and 2009-10. More than 80,000 patients received silicone implants; the rest received implants filled with sterile saline solution.

Seventy-two per cent of the patients underwent primary breast augmentation, 15 per cent had revision augmentation, 10 per cent had primary breast reconstruction, and three per cent had revision reconstruction procedures.

The large size of the database enabled researchers to assess the risk of rare adverse outcomes.

Women receiving silicone implants were at increased risk of several rare harms compared to the general population.

Silicone implants were also associated with a 4.5-fold increase in the risk of stillbirth, but no significant increase in the risk of miscarriage.

Risk of melanoma, a serious type of skin cancer, was nearly four times higher in women with silicone implants. There was no significant association with the risk of suicide, which had been suggested by a previous study.

The database included just one case of breast implant-associated anaplastic large cell lymphoma -- a rare but serious type of cancer previously linked to breast implants.

Compared to saline-filled implants, silicone implants were also linked to a higher risk of some surgical complications. These included capsular contracture (scarring around the implant), which occurred at a rate of 5.0 per cent with silicone implants versus 2.8 per cent with saline-filled implants.

Capsular contracture occurred in 7.2 per cent of primary breast augmentation procedures and was the most common reason for reoperation in this group.

While certain rare harms appeared to be more common in women with silicone implants, absolute rates of these adverse outcomes were low.

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Agencies
January 4,2020

Washington D.C., Jan 3: A new study has found out that diet significantly affects the mental health and well being of an individual.

The study was published in the journal European Neuropsychopharmacology.

"We have found that there is increasing evidence of a link between a poor diet and the worsening of mood disorders, including anxiety and depression. However, many common beliefs about the health effects of certain foods are not supported by solid evidence," said the lead researcher, Professor Suzanne Dickson.

According to the researchers, the link between diet and mental health can be firmly established in certain cases like that of the ability of a ketogenic diet being helpful for children with epilepsy and the impact of vitamin B12 deficiency on poor memory, depression and fatigue.

"With individual conditions, we often found very mixed evidence. With ADHD for example, we can see an increase in the quantity of refined sugar in the diet seems to increase ADHD and hyperactivity, whereas eating more fresh fruit and vegetables seems to protect against these conditions," said Dickson

But there are comparatively few studies, and many of them don't last long enough to show long-term effects," added Dickson.

The study further concludes that some food items can be associated with treatment and the betterment of certain mental health conditions.

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Agencies
June 10,2020

Early treatment with the antiviral drug remdesivir has been found to reduce viral load and prevent lung disease in macaques infected with SARS-CoV-2 that causes COVID-19, according to a study.

The findings, published in the journal Nature on Tuesday, support the early use of remdesivir treatment in patients with COVID-19 to prevent progression to pneumonia.

Researchers from the National Institutes of Health in the US noted that remdesivir has broad antiviral activity and has been shown to be effective against infections with SARS-CoV and MERS-CoV in animal models.

The drug is being tested in human clinical trials for the treatment of COVID-19, they said.

Researcher Emmie de Wit and colleagues investigated the effects of remdesivir treatment in rhesus macaques, a recently established model of SARS-CoV-2 infection.

Two sets of six macaques were inoculated with SARS-CoV-2.

One group was treated with remdesivir 12 hours later -- close to the peak of virus reproduction in the lungs -- and these macaques received treatment every 24 hours until six days after inoculation.

In contrast to the control group, the researchers found that macaques that received remdesivir did not show signs of respiratory disease, and had reduced damage to the lungs.

Viral loads in the lower respiratory tract were also reduced in the treated animals; viral levels were around 100 times lower in the lower-respiratory tract of remdesivir-treated macaques 12 hours after the first dose, they said.

The researchers said that infectious virus could no longer be detected in the treatment group three days after initial infection, but was still detectable in four out of six control animals.

Despite this virus reduction in the lower respiratory tract, no reduction in virus shedding was observed, which indicates that clinical improvement may not equate to a lack of infectiousness, they said.

Dosing of remdesivir in the rhesus macaques is equivalent to that used in humans, the researchers noted.

They cautioned that it is difficult to directly translate the timing of treatment used in corresponding disease stages in humans, because rhesus macaques normally develop only mild disease.

However, researchers said the results indicate that remdesivir treatment of COVID-19 should be initiated as early as possible to achieve the maximum treatment effect.

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Agencies
July 2,2020

The American pharmaceutical giant Pfizer Inc. and the European biotechnology company BioNTech SE have conducted an experimental trial of a COVID-19 vaccine candidate and found it to be safe, well-tolerated, and capable of generating antibodies in the patients.

The study, which is yet to be peer-reviewed, describes the preliminary clinical data for the candidate vaccine -- nucleoside-modified messenger RNA (modRNA), BNT162b1.

It said the amount of antibodies produced in participants after they received two shots of the vaccine candidate was greater than that reported in patients receiving convalescent plasma from recovered COVID-19 patients.

"I was glad to see Pfizer put up their phase 1 trial data today. Virus neutralizing antibody titers achieved after two doses are greater than convalescent antibody titers," tweeted Peter Hotez, a vaccine scientist from Baylor College of Medicine in the US, who was unrelated to the study.

Researchers, including those from New York University in the US, who were involved in the study, said the candidate vaccine enables human cells to produce an optimised version of the receptor binding domain (RBD) antigen -- a part of the spike (S) protein of SARS-CoV-2 which it uses to gain entry into human cells.

"Robust immunogenicity was observed after vaccination with BNT162b1," the scientists noted in the study.

They said the program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target component of the novel coronavirus, SARS-CoV-2.

Based on the study's findings, they said BNT162b1 could be administered in a quantity that was well tolerated, potentially generating a dose dependent production of immune system molecules in the patients.

The research noted that patients treated with the vaccine candidate produced nearly 1.8 to 2.8 fold greater levels of RBD-binding antibodies that could neutralise SARS-CoV-2.

"We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings," said Kathrin U. Jansen, study co-author and Senior Vice President and Head of Vaccine Research & Development, Pfizer.

"We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible," Jansen said.

According to Ugur Sahin, CEO and Co-founder of BioNTech, and another co-author of the study, the preliminary data are encouraging as they provide an initial signal that BNT162b1 is able to produce neutralising antibody responses in humans.

He said the immune response observed in the patients treated with the experimental vaccine are at, or above, the levels observed from convalescent sera, adding that it does so at "relatively low dose levels."

"We look forward to providing further data updates on BNT162b1," Sahin said.

According to a statement from Pfizer, the initial part of the study included 45 healthy adults 18 to 55 years of age.

It said the priliminary data for BNT162b1 was evaluated in 24 subjects who received two injections of 10 microgrammes ( g) and 30 g -- 12 subjects who received a single injection of 100 g, and 9 subjects who received two doses of a dummy vaccine.

The study noted that participants received two doses, 21 days apart, of placebo, 10 g or 30 g of BNT162b1, or received a single dose of 100 g of the vaccine candidate.

According to the scientists, the highest neutralising concentrations of antibodies were observed seven days after the second dose of 10 g, or 30 g on day 28 after vaccination.

They said the neutralising concentrations were 1.8- and 2.8-times that observed in a panel of 38 blood samples from people who had contracted the virus.

In all 24 subjects who received two vaccinations at 10 g and 30 g dose levels, elevation of RBD-binding antibody concentrations was observed after the second injection, the study noted.

It said these concentrations are 8- and 46.3-times the concentration seen in a panel of 38 blood samples from those infected with the novel coronavirus.

At the 10 g or 30 g dose levels, the scientists said adverse reactions, including low grade fever, were more common after the second dose than the first dose.

According to Pfizer, local reactions and systemic events after injection with 10 g and 30 g of BNT162b1 were "dose-dependent, generally mild to moderate, and transient."

It said the most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 g dose, which was severe.

The study noted that there was no serious adverse events reported by the patients.

Citing the limitations of the research, the scientists said the immunity generated in the participants in the form of the T cells and B cells of their immune system, and the level of immunity needed to protect one from COVID-19 are unknown.

With these preliminary data, along with additional data being generated, Pfizer noted in the statement that the two companies will determine a dose level, and select among multiple vaccine candidates to seek to progress to a large, global safety and efficacy trial, which may involve up to 30,000 healthy participants if regulatory approval to proceed is received.

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