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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Dying Scientist and his Rogue Vaccine Trial – Wired (Amanda Schaffer | May 2018)0

Posted by Admin in on June 18, 2018
 

Bill Halford was convinced he’d found a miracle cure, but he was running out of time to prove it. So he teamed up with a Hollywood executive and recruited a band of desperate patients.

IN A PHOTO from 2009, Bill Halford, who was then 40 years old, looks like a schoolboy who hasn’t quite grown into his big ears. He wears an ill-fitting red shirt tucked into belted khakis; his jawline is square and his eyes are full of wonder. The picture was taken at Southern Illinois University, where he was a respected professor. A few years before, he had made a significant discovery—one that would determine the course of his life.

Halford, a microbiologist, had taken an interest in the peculiar nature of herpes—how it lies dormant in the nervous system and reactivates to cause disease. Herpes is one of the most pervasive viral infections in the world, sometimes causing painful genital blisters, and it has frustrated scientists attempting to find a cure. But in 2007, Halford realized that a weakened form of the virus he’d been studying might serve as a vaccine. He designed an experiment in which he inoculated mice with this variant, then exposed them to the wild-type form of the virus. In 2011 he published the results: Virtually all the mice survived. By contrast, animals that were not injected with his vaccine died in large numbers. It was promising science.

That same year, however, Halford became seriously ill. At first he thought he had a sinus infection, but it turned out to be a rare and aggressive form of cancer, sinonasal undifferentiated carcinoma. Halford was 42 years old at the time, with two teenage children. He underwent chemotherapy and radiation followed by surgery, but he was told that the form of cancer he had did not usually stay at bay for long. Halford had always been determined—“a 90-hours-a-week sort of researcher,” as his wife, Melanie Halford, puts it. The cancer diagnosis only seemed to harden his focus. Others had tried, and failed, to develop a herpes vaccine, but Halford was convinced that his method—using a live, attenuated form of the virus—would succeed. He would use whatever time he had left to show he was right.

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Why all randomised controlled trials produce biased results (Papers: Alexander Krauss | March 2018)0

Posted by Admin in on June 7, 2018
 

Abstract

Background: Randomised controlled trials (RCTs) are commonly viewed as the best research method to inform public health and social policy. Usually they are thought of as providing the most rigorous evidence of a treatment’s effectiveness without strong assumptions, biases and limitations.

Objective: This is the first study to examine that hypothesis by assessing the 10 most cited RCT studies worldwide.

Data sources: These 10 RCT studies with the highest number of citations in any journal (up to June 2016) were identified by searching Scopus (the largest database of peer-reviewed journals).

Results: This study shows that these world-leading RCTs that have influenced policy produce biased results by illustrating that participants’ background traits that affect outcomes are often poorly distributed between trial groups, that the trials often neglect alternative factors contributing to their main reported outcome and, among many other issues, that the trials are often only partially blinded or unblinded. The study here also identifies a number of novel and important assumptions, biases and limitations not yet thoroughly discussed in existing studies that arise when designing, implementing and analysing trials.

Conclusions: Researchers and policymakers need to become better aware of the broader set of assumptions, biases and limitations in trials. Journals need to also begin requiring researchers to outline them in their studies. We need to furthermore better use RCTs together with other research methods.

Key messages

  • RCTs face a range of strong assumptions, biases and limitations that have not yet all been thoroughly discussed in the literature.
  • This study assesses the 10 most cited RCTs worldwide and shows that trials inevitably produce bias.
  • Trials involve complex processes – from randomising, blinding and controlling, to implementing treatments, monitoring participants etc. – that require many decisions and steps at different levels that bring their own assumptions and degree of bias to results.

Keywords: Randomised controlled trial, RCT, reproducibility crisis, replication crisis, bias, statistical bias, evidence-based medicine, evidence-based practice, reproducibility of results, clinical medicine, research design

Krauss, A. (2018) Why all randomised controlled trials produce biased results. Annals of Medicine. 50:4, 312-322, DOI: 10.1080/07853890.2018.1453233
Publisher (Open Access): https://www.tandfonline.com/doi/full/10.1080/07853890.2018.1453233

(US) ‘Right-to-try’ bill passes Congress – CNN (Michael Nedelman and Jacqueline Howard | May 2018)0

Posted by Admin in on June 3, 2018
 

With a House of Representatives vote Tuesday, Congress passed legislation that could give terminally ill patients a way to independently seek drugs that are still experimental and not fully approved by the US Food and Drug Administration.

Despite being lauded by some politicians (including subsequent to this story President Trump) this law is likely to concern most people involved in human research ethics (it certainly does concern us).

The House voted 250-169 in favor of the bill, which the Senate passed in August. The bill will now be sent to President Trump, who is expected to sign it.
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“This is an extraordinarily great day,” Democratic Sen. Joe Donnelly of Indiana, one of the original cosponsors of the bill, said in a press conference after the event. Donnelly said he met with Vice President Mike Pence a few weeks ago and urged him to push for a House vote on the bill.
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(US) FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research – KHN (Marisa Taylor | April 2018)0

Posted by Admin in on May 15, 2018
 

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned.

SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an institutional review board.

According to four people with knowledge about the inquiry, the FDA’s Office of Criminal Investigations is looking into whether anyone from SIU or Halford’s former company, Rational Vaccines, violated FDA regulations by helping Halford conduct unauthorized research. The probe is also looking at anyone else outside the company or university who might have been complicit, according to the sources who asked not to be identified because of the sensitivity of the matter.

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