Eloise Gibson is Newsroom's environment and science editor. She's written for the New Zealand Herald, Stuff.co.nz, The Listener, and BBC Future.com. Twitter: @eloise_gibson.

Newsroom Special Inquiry

Legal threat to suppress clinical study

Sir Ray Avery tried to suppress publication of a clinical study carried out at Auckland Hospital showing that an intravenous drip controller he was promoting didn’t work as well as expected.

The idea had been to design a cheap, easy-to-use device to deliver intravenous medicines and rehydration fluid more accurately to people in poorer countries, replacing the cheap devices that poorer hospitals often use in place of pricey electronic pumps.

Full of early promise, the Acuset controller was named one of 10 finalists in the prestigious $100,000 Saatchi and Saatchi Award for World Changing Ideas for 2007/2008.

But clinical trials at Auckland City Hospital in 2008 revealed it was not more accurate than a ubiquitous 50c device known as a roller clamp, which health workers in developing world hospitals already use widely. The Acuset is now being promoted as part of a set of products, with other components that are claimed to improve its performance.

In 2015, Avery legally threatened a researcher to try to keep the clinical study findings quiet. He requested a “quiet retraction” of a paper a team of researchers had sent to a medical journal, telling one researcher “you really don’t want this from a career perspective”.

In a follow-up email to the same researcher he added that his lawyer, Mai Chen, had “successfully removed similar material [from the public domain] on a previous occasion, so it can be done”.

More recently, the charity leader has said he’s running clinical trials of his LifePod infant incubators , however he’s been silent on details including which Indian hospital is conducting the trial.

The published study was one of two clinical studies carried out by prominent researchers in Auckland, both of which yielded disappointing results.

Avery didn’t disclose those to Newsroom when we asked last month about clinical evaluations of the Acuset at Auckland hospital. Nor are they listed in a table of research for prospective investors in a company Avery set up to commercialise the Acuset and other drip set components. However, that research list includes another study of the Acuset (before it was incorporated in a more extensive package of products).

Today Avery said he believed Newsroom was asking about a different study – not involving the Acuset – when we asked about trials of the Acuset at Auckland hospital.

He acknowledged they happened but said they “did not reflect normal usage” of the device, related to an earlier, obsolete version of the product, and that one of the two studies was done without his written consent.

Hopeful beginnings

The Acuset was born after an American non-profit, Design That Matters, approached Avery with the idea of creating a better alternative for developing world hospitals that can’t afford $2000-plus for electronic devices.

Avery turned to Auckland medical manufacturer Murray Fenton, who worked with staff at his company Adept to come up with an initial design. Trade Me founder and philanthropist Sam Morgan agreed to fund the die-making tooling required to produce the gadgets.

“This paper may result in a public debriding of Sir Ray’s reputation, particularly with respect to Sir Ray Avery's disruptive technology and design pertaining to the Lifepod Incubator …. I am requesting a silent retraction of this paper.” - Sir Ray Avery

In 2007, prominent researchers at Auckland City Hospital helped Avery by arranging a Nepalese trial of the Acuset, using devices he supplied. The Nepalese trial seemed to show that it was much more accurate than a roller clamp, making everyone involved hopeful that it would help people in developing countries.

But the Auckland researchers felt the results from Nepal seemed too good to be true. Emails from the period show – and the researchers confirmed to Newsroom – that they told Avery they wanted to conduct a clinical trial in Auckland where they could control the study set-up and make sure the findings were accurate, before risking making claims about the device’s performance.

Two clinical studies were conducted by different teams of researchers at Auckland City Hospital. Both showed there was no significant difference in accuracy between the Acuset and roller clamp devices.

A trail of documents from 2007 and 2008 records the progress of the studies, with Avery discussing various issues with the researchers and pressing them to write up their results. He promised to discuss the results with the Acuset’s then-designers and manufacturers, Adept, who were hoping to interest an international distributor in a partnership.

The 2008 annual report of the Northern X Regional Ethics committee, which is publicly available, shows the committee granted ethics approval on May 26, 2008 for a trial of “administration of intravenous fluids using Acuset versus roller-clamp” at Auckland District Health Board.

But when it became clear the results did not match the Nepalese study, Avery accused some of the researchers of “shoddy work”. He raised various technical issues, at one point telling staff at Adept that a benchtop study at Auckland hospital had been abandoned because of a malfunctioning measuring gadget called a drip counter.

Newsroom asked Professor Ian Bissett, the academic head of the Department of Surgery at University of Auckland, about that claim: he says calibration using a drip counter in a clinical study of the Acuset he was involved in showed “remarkable accuracy”.

Newsroom was able to confirm with Bissett that the Acuset was studied at Auckland City Hospital on both the benchtop and in patients in 2008. Although the Acuset took nurses less time to set than the roller clamp, it didn’t result in any significant improvements in accuracy.

A screenshot from the Acuset IV website.

Another study done at around the same time, led by a different researcher at the hospital, enlisted more than 60 nurses and compared the nurses’ subjective assessment of the device’s performance with an objective assessment using a drip counter. The researchers of that study also found there was no accuracy advantage to using the Acuset, despite the nurses mistakenly thinking the device was more accurate on the basis that it ‘looked better’.

After learning of the disappointing results from the clinical studies, Avery and others continued to look at ways to improve the Acuset by adding components, utilising help from one of the researchers involved in the original trials.

But Avery took exception when, several years later, the research team published their findings from the study with nurses in a medical journal. The paper, published in 2015, focused on nurses’ perceptions of the product design and discussed the implications for manufacturing good-looking medical products. It didn’t name the Acuset, though it thanked Avery.

The researcher who’d headed the nurses’ study told Avery about the forthcoming paper, thinking he’d be interested. Avery replied: “This paper may result in a public debriding of Sir Ray’s reputation, particularly with respect to Sir Ray Avery's disruptive technology and design pertaining to the Lifepod Incubator …. I am requesting a silent retraction of this paper.” He went on: “You may wish to consult with your legal advisors, but unless I get a retraction I will hand it over to my lawyer Mai Chen and as part of my friendly FMCE [sic] you really don’t want this from a career perspective.”

The researcher replied to Avery that his response was “completely unexpected. We understood that you were keen for us to evaluate the performance of the version of the device and had several meetings discussing various projects. You lent us the version for the purpose of evaluation ... Please also note that this study was conducted at the time we were in discussion.”

Although he stood by the study’s findings, the researcher told Avery he’d see about retracting it —then contacted the medical journal to discuss options including removing Avery’s name from the acknowledgements. But he was told it was too late and the paper was published.

Newsroom asked Avery about the legal threat. He says he made it because the researchers didn’t have his written consent to do the second study, with the nurses, and the devices they used were “obsolete”. Newsroom has confirmed that the two studies were done over the same period, using devices Avery supplied, though the findings from the nurses’ study weren’t published until years later.

Avery supplied us with an email Bissett sent Avery on October 2008. Bissett was not an author of the study with nurses, but was involved in the other trials.

In the email, Bissett says that, given the disappointing clinical results he and the other researchers were seeing, “we would not be prepared to” undertake any more trials in patients until studies had shown the Acuset had some advantage.

The email also asks that an instruction manual the researchers had prepared, “not be used for the promotion of Acuset ... We would like to be able to support Acuset, but only after we have got the necessary evidence.”

No mention

A number of things changed for the Acuset after the studies were arranged in 2008: Adept’s Murray Fenton, the original designer of the IV controller, cut ties with the Acuset and asked Avery to remove his company’s name from marketing of the product. Fenton felt Avery was making inflated claims about the product’s ability to be calibrated as a measuring device. “Adept Medical’s reputation and the need to strictly adhere to our obligations for CE certification lead me to ask that reference to Adept be eliminated to the best of your abilities from future press releases or promotions,” he emailed Avery.

Not long afterwards Morgan – who had donated about $600,000 to Avery’s projects, including $300,000 to help develop the Acuset – offered to write off a $100,000 loan in exchange for greater financial transparency from Avery. But the relationship deteriorated and Avery chose to repay the loan, with interest. For his part, Avery says he’d been told he shouldn’t have signed a loan deal with Morgan incurring interest and his charity’s board had advised him to get out of it.

Avery and others continued to develop and promote the Acuset and added components to make a set of products. In 2017 Avery started a company called AIS Technologies Limited to commercialise the concept. That company promotes a whole ‘drip set’ that incorporates a stretchy cord on the fluid bag to counter the effect of gravity as the bag empties, a drip chamber and tubing, as well as the Acuset IV controller device itself.

Marketing and investment material downloaded from AIS Technologies’ website on August 30 makes the stunning claim that the new kit is not only better than a roller clamp but offers similar accuracy to an expensive first-world electronic infusion pump. No clinical studies are cited to support the claim. When asked by Newsroom if there was clinical data from hospitals or patients to back up the claim, Avery replied that this was “proprietary information”.

An AIS Technologies booklet for investors contains a table listing the research carried out to-date, but, while the table lists other studies it omits any mention of the two conducted at Auckland Hospital. However, the table lists a 2007 Nepalese trial of the Acuset. Asked about this, Avery told Newsroom there were two lots of results from Nepal, one of which was conducted by a former chief medical officer at the Bhaktapur Cancer Hospital.

Emails from 2008 show Bissett raised with Avery serious concerns about the reliability of some of the Nepalese results. His concerns alarmed sales staff at Avery’s then-manufacturing partner, Adept, who were hoping to get robust proof of accuracy, which they could use to secure a deal with distributors.

Adept’s sales people were concerned to read in an email from Bissett that the Nepalese data Avery had shared didn’t match what the Auckland researchers were seeing, and that more work was needed to confirm accuracy. They stressed the need to be completely upfront with potential distribution partners. Avery acknowledged in emails that more clinical trials were needed, and promised to discuss the forthcoming results with Adept. He also questioned aspects of the Auckland trials.

Clinical trials at Auckland City Hospital in 2008 revealed the Acuset was not more accurate than a 50c device known as a roller clamp. Photo: John Sefton

In an email to Adept seeking to allay concerns about the trial results, Avery said a second-hand drip counter had malfunctioned and a benchtop study of the Acuset at Auckland Hospital had been ‘abandoned’.

However, Bissett confirmed to Newsroom this month that calibration using a drip counter in the clinical study had showed “remarkable accuracy”.

In July, Newsroom asked Avery about reports that the Acuset had been trialled at Auckland Hospital, after finding mention of a trial online.

He responded that the research and development at Auckland had related to a new fluid bag design, emailing us the following answer: “The University of Auckland R & D related to the automatic hydrostatic compensating IV bag.”

Newsroom then directed Avery to a technology case study of the Acuset we’d found online, which says the Acuset was being evaluated “in a study at Auckland Hospital and in field trials in Nepal”.

Avery responded: “The Auckland Hospital trial referred to was about the 'determination of customer statement of need' and is referenced in the full [investor materials] showing that conventional IV drip systems which use a roller clamp are very inaccurate.”

The study to which he directed Newsroom is a different piece of research highlighting the inaccuracies of the roller clamp device, and didn’t involve the Acuset. Asked today why he didn’t disclose the trials, Avery said Newsroom was asking him about clinical trials in referenced in the investor materials.

As for why those investor materials list the Nepalese study but not the Auckland Hospital ones, he said this: “Because the Auckland trials used a product that does not in any way relate to the current product offering ... the Acuset has been re-designed.” Newsroom pointed out to Avery that the Nepalese study, which is listed in the materials for investors, also used the same, earlier version of the Acuset as the Auckland trials. Avery did not reply on that point.

Last month Avery told Newsroom there’d been clinical studies of the whole drip set package by a multi-national pharmaceutical company, Baxter, which at one point was interested in investing in the Acuset and its associated kit. He couldn’t share the trial results, however. “We partnered with Baxter China and successfully completed 'in hospital' clinical trials showing that the Acuset Safeguard System was not only better than conventional roller clamp systems but better than proprietary single use flow controllers,” he told Newsroom in July. “Baxter USA then completed in vivo clinical evaluation in the USA. We can’t share this information because it is the proprietary property of Baxter,” Avery emailed Newsroom.

Avery showed Newsroom a letter from Baxter Asia Pacific, saying Baxter had decided not to proceed with investment in February 2011, despite a technical evaluation having found what Baxter called “clinical benefits”. Baxter cited regulatory hurdles as the reason for declining further investment. Avery says those hurdles have since been cleared by regulators.

If the new set-up is successfully commercialised and distributed, it will be a more expensive proposition than was first envisaged. The original plan, which first attracted donors and accolades, was for a cheap, reusable device to sell at low-cost to cash-strapped hospitals. When buying the new kit, however, hospitals would need to purchase a single-use IV bag from the company each time they used the Acuset drip set. The marketing materials pitch this feature as a benefit, saying it creates an “ongoing product revenue stream” for AIS Technologies.

AIS Technologies is seeking minimum investments of $10,000 for a total of 17.5 per cent of the company, valuing the company at $7.1 million.

Why publish clinical trials?

New medical devices, like all scientific discoveries, need to be carefully tested to ensure they are safe and effective, improving patient outcomes and/or saving costs.

There are international regulatory bodies, including the FDA in the United States, that determine whether medical devices can be sold in markets.

The decision has to be based on sound evidence, and the primary responsibility for conducting the necessary trials is the company wanting to sell the device.

The evidential process is supposed to make sure unsubstantiated marketing doesn’t put people in danger.

While Avery’s legal threat is an extreme example of trying to silence a piece of research, it is not uncommon for trials to be done on devices or medicines and never published.

Proponents of open science have been pushing for publication of all drug and medical trials, even those ones with negative findings, so people can learn from them.

Siousxie Wiles, a microbiologist and prominent science communicator, says the gaps left by unpublished information can have real consequences.

“It’s so important for the results of all clinical trials and fundamental science research to be published, or at the very least made available for others to access in some form,” she says. “All around the world researchers, clinicians, and policy makers use the results from previous studies to do things like design further experiments or trials, or to decide what the best treatments are to offer patients. When information is missing because it hasn’t been published it can have massive consequences for medicine and human health, from time and money being wasted doing studies that were never going to work, to patients receiving useless or even dangerous treatments.”

There’s a move to encourage researchers to publish their study designs and hypotheses before they embark on doing a trial, and even a US law that allows the FDA to fine people who don’t report certain clinical trial results.

There’s also another, unofficial ethical obligation on scientists: when researchers in a field have doubts about a new finding – or even if they don’t – they are supposed to try to repeat it, to ensure the result stacks up.

That is what the Auckland City Hospital researchers did with the Acuset, when they suggested re-testing the device after a promising Nepalese study. One researcher told Newsroom he wanted the device to succeed, and help people. But it wouldn’t have been responsible to risk people relying on information that mightn’t be robust, so they had to repeat the study under carefully-controlled conditions.

Avery: The story so far

Newsroom began speaking to Avery and his current and former collaborators in July, when a fundraising concert for the LifePod was planned.

The goal was to raise $4 million from a Live Aid-style concert at Eden Park and use the money to buy 2000 incubators to save a million babies. The “million” was based on Avery’s estimate that each incubator would save 500 babies over its 10-year lifetime, though he acknowledged the figure was a “marketing” number.

During reporting for that story and in the weeks since we have spoken to more than a dozen people, including philanthropists, scientists, manufacturers and engineers, who’ve had adverse experiences during their involvement with Avery. A key concern was a lack of transparency and/or rigorous process.

Many say they bowed out of his projects after growing concern at his methods.

Four people, including one of the researchers in this story, say he made legal threats against them going public with information about him.

Avery himself has reported acrimony between himself and other former associates he mistakenly believed Newsroom had spoken to for its reporting. He’s also acknowledged things ended badly between him and US non-profit Design that Matters, with whom he worked in the early days of the LifePod and the Acuset.

In his own defence, Avery raised allegations against a few of those we spoke to, sometimes of a personal nature. He told Stuff.co.nz "If you've had a business over 20 years and with 200 volunteers it's inevitable you'll have a fallout with someone along the way.”

Former collaborators and contacts who agreed to be named in our reporting include philanthropist Sam Morgan, who granted $600,000 to various Avery ventures, former Fisher and Paykel engineer Kip Marks, who spoke out about his worries about the LifePod design process after earlier volunteering to help, and medical manufacturer Murray Fenton, who came up with the original design for the Acuset controller.

With respect to the LifePods, which have attracted millions of dollars’ worth of donated time and money, Newsroom last month found they were not in production to any scale, don’t yet have ISO certification, and clinical trials in India hadn’t been confirmed, despite some primary schools and other donors believing Lifepods had already been purchased and shipped using money they’d raised for that purpose. The factory where LifePods are supposed to be built in Chennai is undergoing re-building, Avery says, and it is the factory that will take charge of gaining ISO accreditation.

Avery points out that multinationals also take many years to develop medical devices, working with vastly greater resources.

But he acknowledges his deadlines have shifted. In August 2012 he told Radio New Zealand the Liferaft incubators, as they were then called, would hopefully be field-tested in Samoa and the Cook Islands in early 2013. The estimated number of babies-saved-per-incubator was then much higher: "We think that one incubator over its life span will save between 25,000 and 30,000 children ... over the prescriptive 10-year life span,” Radio NZ reported him saying.

In 2014, Avery launched a campaign to raise $2 million to get the LifePod to the production stage. Twenty-five prototypes had been built, it was reported, and the $2 million was to finance the work needed to obtain medical device certification from the ISO.

In September 2015, the NZ Herald reported that the LifePod had reached the manufacturing stage and Avery hoped to have it on the market in early 2016.

In April 2016, Stuff reported that “by the end of 2016 Avery hopes to have 20 LifePods operating in the Pacific Islands”.

The latest estimate he supplied was February 2019.