A class action suit against an Australian IVF provider is a reminder that IVF is a huge industry

Remember Erin Brockovich, an inspiring consumer advocate and environmental activist in winning a US$333 million class-action lawsuit, the biggest of its kind in US history? She brought a small town to its feet and a huge corporation to its knees, as the tagline goes.

A class action was just lodged against Monash IVF Pty Ltd, the owner of IVF clinics in Australia. The lawsuit emerges amid revelations that the innovative genetic testing used by Monash IVF is less reliable than initially thought.

The lead plaintiff, Ms Danielle Bopping, who is in her 40s, was informed by Monash IVF that her last embryo, categorised as abnormal, may have been viable. It is claimed that the fertility clinic may have incorrectly labelled healthy embryos as abnormal before discarding them through a now-suspended non-invasive genetic testing programme.

Ms Bopping will provide instructions to the legal firm about the case's conduct and adduce evidence during the proceedings. The legal documents were filed in the Supreme Court… MORE





Arkansas case shows path forward for banning Down Syndrome abortions

A novel argument for chipping away at legalised abortion in the United States is catching on amongst the judiciary: abortion should not be used for eugenic purposes.

Earlier this month the US Court of Appeals for the Eighth Circuit struck down Arkansas Acts 493 and 619. The first attempted to ban abortions after 18 weeks because it is possible that some foetuses are viable at that stage. The second would have forbidden abortions of a foetus with Down Syndrome. Little Rock Family Planning Services sued.

The court found that it had no choice but to uphold the US Supreme Court which had ruled in Planned Parenthood of Southeastern Pennsylvania. v. Casey (1992) that “a State may not prohibit any woman from making the ultimate decision to terminate her pregnancy before viability.” The Arkansas abortion lobby won the case. However, that is not the end of the story.

In 2019, US Supreme Court Justice Clarence Thomas penned an eloquent dissent… MORE





Forced sterilization policies in the US targeted minorities and disabled – and lasted into the 21st century

An operation in 1941 on South Side of Chicago 

In August 1964, the North Carolina Eugenics Board met to decide if a 20-year-old Black woman should be sterilized. Because her name was redacted from the records, we call her Bertha. She was a single mother with one child who lived at the segregated O'Berry Center for African American adults with intellectual disabilities in Goldsboro. According to the North Carolina Eugenics Board, Bertha had an IQ of 62 and exhibited “aggressive behavior and sexual promiscuity.” She had been orphaned as a child and had a limited education. Likely because of her “low IQ score,” the board determined she was not capable of rehabilitation.

Instead the board recommended the “protection of sterilization” for Bertha, because she was “feebleminded” and deemed unable to “assume responsibility for herself” or her child. Without her input, Bertha’s guardian signed the sterilization form.   

Bertha’s story is one of the 35,000 sterilization stories… MORE





Regenerative clinics: strong language from FDA

A strongly worded article in JAMA gives a heads-up to stem cell clinics operating outside of the regulatory framework that they may not be granted more time to reach compliance with Food and Drug Administration (FDA) regulations.

The article, written by the FDA during a pandemic when it is busy with other concerns, underscores the agency’s duty to promote evidence-based regenerative medicine. 

Authors Stephen Hahn, the FDA’s new commissioner, and Peter Marks, the director of the Center for Biologics and Evaluation and Research, write that “these products, whether autologous or allogeneic, are not inherently safe and may be associated with serious adverse consequences”.

There has been an increasing number of unscrupulous clinics in US advertising treatments for diseases and conditions ranging from autism to ageing. But the safety and efficacy of these products are yet to be proven. For instance, three women became blind after receiving untested stem cell treatment on their eyes in a Florida clinic.

MORE




There is a bright side. If you catch Covid-19, you’ve missed out on bubonic plague

Milan is in the grip of an epidemic. Towns have been quarantined. Public gatherings have been cancelled. The streets are empty. Public officials try to dampen mounting hysteria. Dark rumours are circulating. Hospital wards are overflowing.

The coronavirus?

No, the Great Plague of 1630 in which perhaps a million (1,000,000) people died. About 35,000 have died so far in Italy’s coronavirus outbreak. That figure alone should immunise you against nostalgia for the Good Old Days. The panic and suffering of the citizens of Milan during the bubonic plague — who also had to cope with a drought, a famine and the Thirty Years’ War — make coronavirus seem like a Sunday summer picnic.

Europe, to say nothing of the rest of the world, has had plagues a-plenty, but Milan’s torment may be the best known thanks to its vivid description in the Great Italian Novel, I Promessi Sposi (The Betrothed). Written by Alessandro Manzoni, it was published in 1827… MORE





Things you should think about when you hear ‘vaccine by end of the year’

On July 27, 2020, the Washington Post reported, Two coronavirus vaccines begin the last phase of testing: 30,000-person trials, wrapping it in historical terms:

At 6:45 a.m. Monday, a volunteer in Savannah, Ga., received a shot in the arm and became the first participant in a massive human experiment that will test the effectiveness of an experimental coronavirus vaccine candidate. The vaccination marks a much-anticipated milestone: the official launch of the first in a series of large U.S. clinical trials that will each test experimental vaccines in 30,000 participants.

“We are participating today in the launching of a truly historic event in the history of vaccinology,” Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said at a news conference. He noted that the United States has never moved faster to develop a vaccine, from basic science to a large Phase 3 trial designed to test safety and effectiveness.

Fauci predicted… MORE





Covid-19: should we deliberately infect volunteers?

In a desperate race to develop a Covid-19 vaccine, it is tempting for scientists to compromise quality control and rigour. But crises are not an excuse for lowering the bar of stringent ethical and scientific standards. Ethicists have warned scientists not to cave into bad science. Can permitting volunteers to be purposely infected with COVID-19 to develop a vaccine be done ethically?

Yes, according to Adair D. Richards, of the University of Warwick, in the UK. This sounds disturbing and reminds us of past ethical disasters, e.g. the Tuskegee study of untreated syphilis amongst poor African-American men in Georgia in the 1930s.

In recent research, Dr Richards designed ethical guidelines to guide researchers on an ethical path to purposely infect participants who have been provided with a vaccine candidate with Covid-19 (known as ‘challenge studies’). The volunteers who are vaccinated are given a dose of the virus so the scientist can determine whether the vaccine works. This… MORE





Unscrupulous scammers are selling stem cell therapies for Covid-19

It is alarming that unsubstantiated stem cell-based treatments for Covid-19 are cropping up everywhere. Bioethicist Leigh Turner, of the University of Minnesota, recently flagged stem-cell-based “therapies” in a leading journal, Stem Cell Stem.

Turner worries that users of these so-called treatments for Covid-19 will be harmed by products that haven't been rigorously tested, or that they'll forgo measures like physical distancing as they believe the product will shield them from being infected.

He notes a business in Colorado selling mesenchymal stem cell exosomes "for patients that need to boost their immune system" or who want "additional defence against the virus" for US$3,000. Clinics in Alabama, Arizona, California, Delaware, Florida and Pennsylvania have made similar claims; some advertise stem cell therapies as a preventive step while others claim it can repair damage from Covid-19.

Other companies offer biobanking of one’s own stem cells. "Having a frozen line of one's own personal mesenchymal stem cells could prove life-saving should someone… MORE





Mass gatherings: OK. Mass: not OK

If you can remember that long ago, the only protesters defying Covid-19 lockdowns in the United States were small crowds of roughnecks from flyover country waving flags and brandishing placards at State capitals.

Nonetheless, petty incidents like this still outraged bioethicists and public health experts. Writing in PennLive, a Pennsylvania blog, four of them, including the nationally-known bioethicist Art Caplan, argued that those protesters were freeloading on the sacrifices made by people who observed lockdown restrictions.

They had little sympathy for them if they fell ill with the coronavirus: “If the protesters can’t be persuaded that they are wrong and their behavior is dangerous, they should own up to their political commitment and sign and carry a pledge stating they decline all medical care to treat Covid-19, should they fall ill if resources are being rationed.”

That was then.

Now, crowds of tens of thousands have gathered to protest the appalling tragedy of the death of George Floyd in cities across… MORE





Is seeking ‘herd immunity’ ethical?

Several health experts have proposed a “herd immunity” strategy for managing the coronavirus pandemic. This would involve allowing the virus to spread in a controlled way so as to achieve population immunity — even though this may expose vulnerable members of the community to an increased risk of infection.

While Australia has managed so far to control the spread of the virus, the number of new infections may increase as state and territory government move to ease social distancing and self-isolation measures. The situation in other regions such as North America and Europe is much worse, and initial strategies of strict containment have in some cases been abandoned in favour of mitigation policies.

In light of this, many commentators argue that governments should officially make herd immunity — rather than containment or virus suppression — the end goal of their COVID-19 policies. Harvard Medical School Professor Martin Kulldorff, for example, recently argued that we have no choice but to allow the virus to spread… MORE




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