A Sydney gastroenterologist who has been enthusiastically promoting an unapproved Covid-19 treatment, including to Australian politicians and general practitioners, has filed a patent in the US for the same treatment, allowing him to commercialise and profit from it, if approved.
Prof Thomas Borody has been quoted in medical newsletters and publications, and in news outlets including the Financial Review, the Daily Telegraph and the Australian, promoting what he describes as a “triple therapy protocol” to treat and cure Covid-19.
The protocol involves a combination of the anti-parasitic drug ivermectin, zinc and the antibiotic doxycycline.
In December 2020 Borody filed a patent in the US for therapeutic combinations of drugs, including a combination of ivermectin, an antibiotic and zinc. Patenting a treatment means the owner of the patent is allowed to exclusively manufacture, market and profit from the drug until the patent expires, usually after 20 years.
Borody did not declare in numerous media interviews, or in his appeals to state and federal governments for funding and adoption of the treatment, that he also sought to potentially profit from it. While this is not illegal or in breach of professional regulations, medical and research experts Guardian Australia spoke to expressed concern that it may be unethical and a conflict of interest.
In a statement to the Guardian sent via lawyers, Borody denied any wrongdoing and said: “My client has never hidden the fact that he applied for patents over his -19 treatment. That is a matter of public record for some time now.”
On 23 August 2020, four months before filing the patent, Borody wrote to the Australian health minister, Greg Hunt, requesting funding for the therapy. Hunt responded that Borody should apply for funding through independent processes to study the ivermectin treatment as part of a clinical trial.
When asked if Borody had declared his intentions to patent the therapy, or made them aware once it was filed, a spokesperson for Hunt told Guardian Australia: “We are not aware of Prof Borody’s private interests and to the best of our knowledge have no record of having received any such declaration.”
Borody has been lobbying the federal government for more than a year to support the treatment, both before and after the filing of the patent.
The former Liberal MP and now leader of the United Australia party, Craig Kelly, has promoted Borody and the treatment on Twitter, and in February urged the national Covid evidence taskforce, which sets guidelines for clinicians, to “please look at the evidence” for the treatment, citing Borody’s work. It is not clear whether Kelly was aware of the patent application at the time.
On Twitter, Kelly has claimed government and pharmaceutical companies refuse to endorse ivermectin as a treatment because it is not profitable, given that it is a drug that has long existed and is cheap to produce. “The moment that Big Govt accepts cheap & accessible Ivermectin can be effective & would set us free quickly, it would stop Big Pharma making BIG $$$ Big Pharma JUST playing us for $$$,” Kelly wrote on Twitter on 11 July.
Kelly told Guardian Australia in a statement: “I have no problems with people like Prof Borody seeking to protect their intellectual property when they discover a new treatment, as do the big pharmaceutical companies who aggressively protect their intellectual property, even to the extent of denying access to developing countries.
“I first spoke to Professor Borody in May of last year … And I’m aware that he has invested a substantial sum of his own money to undertake trials and develop the intellectual property.”
Lobbying the government
In July this year Borody emailed a doctor who was also lobbying the government and attached his triple-drug “treatment protocol to control Covid-19 in NSW in conjunction with vaccination”. Borody suggested the treatment could “curb the current outbreak rapidly”.
“This can be rolled out across Australia not just NSW,” he wrote. He also attached a pre-print scientific paper that he claimed showed the efficacy of the protocol and a “near 100% cure” rate in 24 patients.
“Thank you for bringing this to the Minister,” Borody wrote to the doctor. “This approach adds a badly needed ANTIVIRAL TREATMENT to the VACCINE …. to stop the outbreak, [and] abolish all lockdowns. A zoom explanation for further details and plans would most likely be of help to a Ministerial assistant.”
This email was then forwarded to the treasurer, Josh Frydenberg. Neither the treatment protocol nor the pre-print paper attached to the email declared that Borody had filed an application for a patent for the treatment in the US, and another one in France.
A study co-authored by Borody calling for urgent trials of multi-drug therapies, published in December 2020, after the patent was filed, also failed to disclose the patent. “There is nothing to disclose,” the study says under its “Conflict of Interest” heading.
But another study co-authored by Borody and published in August this year, titled “Ivermectin: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19”, does make clear that Borody is “a principal in Topelia Therapeutics (Ventura, California), which seeks to commercialize cost-effective treatments for COVID-19, including IVM [ivermectin]”. A “competing interest statement” in another study, a pre-print published in July, entitled “Effectiveness of Ivermectin-Based Multidrug Therapy in Severe Hypoxic Ambulatory COVID-19 Patients”, also states that Borody and another author have “patents relevant to the study”.
In August 2020 Borody’s Centre For Digestive Diseases issued a press release promoting the triple treatment, encouraging GPs to prescribe the drugs “off label”. Off-label prescribing, which is legal, is when a doctor prescribes a drug to treat a condition it is not indicated for by the manufacturer or approved to treat by drug regulators.
The press release again does not refer to any intention by Borody to file a patent for and profit from the same treatment.
The Therapeutic Goods Administration investigated Borody over his centre’s advertising of a prescription medicine as part of its promotion of the treatment protocol.
“The TGA investigated Prof Borody and the Centre for Digestive Diseases’ alleged advertising of a triple-therapy protocol for treating Covid-19 in mid to late 2020,” a spokesperson said. “The advertising compliance investigation was closed following removal of relevant content that promoted the use of the protocol, including a prescription medicine, from the website. Prescription medicines cannot be advertised in Australia unless a permission applies.”
The TGA was forced to change its prescribing rules for ivermectin in September this year due to concerns GPs were prescribing it to patients for the prevention or treatment of Covid-19 despite it not being approved for such use in Australia. There have been reports of poisonings among patients taking higher than recommended doses of the drug in a bid to combat Covid-19.
After moves by the TGA to restrict ivermectin prescribing, Borody’s Centre for Digestive Diseases updated its website to state it could no longer accept referrals for the treatment or prevention of Covid-19 or prescribe ivermectin for Covid-19.
The National Covid-19 Clinical Evidence Taskforce, the body which makes official recommendations to doctors about how to treat the virus, advises in its clinical treatment guidelines not to use ivermectin for the treatment of Covid-19 outside randomised trials with appropriate ethical approval.
Prof Tari Turner, the director of evidence and methods at the taskforce, said: “When claims are made about the effectiveness of treatments, it is vital that any potential conflicts of interest are declared.
“This applies to panel members making guidelines, recommendations, and people designing and conducting research, and also to clinicians advocating treatments.
“These declarations need to be specific enough for others to be able to evaluate the extent to which any conflicts of interest might impact on the statements or claims those people are making.”
There are serious concerns about many studies by other researchers published to date that claim to show ivermectin is an effective Covid-19 treatment either alone or in combination with other drugs. Many of the studies have been criticised for serious flaws in their design and recruitment of patients, and have been shown to be unreliable. There are no strong studies with large numbers of patients published in peer-reviewed medical journals that show ivermectin alone or in combination with other drugs is an effective preventative against or treatment for Covid-19, though these trials are under way. Most studies to date have been too small to be clinically significant, or poorly designed.
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Borody told the Guardian in a statement from his lawyer that he holds 162 patents for different treatments and therapies for various diseases. He referred to his previous work in the 1980s developing the first therapy, also a combination therapy, to fight H pylori and cure peptic ulcers. This went on to become the gold standard treatment for peptic ulcers globally.
“As a practising doctor and medical specialist, I have been at the forefront of medical research for more than 40 years focusing primarily on repurposing safe, effective, cheap and approved therapies resulting in FDA [US Food and Drug Administration] and TGA approved triple therapies,” Borody said in the statement.
“This includes the life-saving triple therapy for peptic ulcers with a track record of having saved millions of lives worldwide and 1,050 lives each year in Australia, as well as more than $10bn in hospitalisation costs.
“That would not have been possible unless the therapy had been patented.”
Assoc Prof Wendy Lipworth, from the University of Sydney’s Health Ethics centre, said: “There’s nothing wrong with applying for a patent.
“But declaring that patent, when you are becoming a public figure for promoting a treatment, is the bare minimum of your ethical obligations …
“As a medical professional, there is an obligation to appraise the evidence subjectively and give advice without bias. I think that’s where the tension is.
“There’s nothing wrong even with having a conflict of interest. What really is the issue is how it is managed, and the most important issue is not declaring it.”
She added: “Part of due diligence at the very least should be to have a declaration at the bottom about conflicts of interests to do with that treatment. To not do that is blatantly unethical.”
The benefit of applying for a patent in the US is it is a signatory to the international patent cooperation treaty, which means by applying in the US, applicants can simultaneously seek protection for an invention in a large number of countries.
The patent expert and principal of Stephens Lawyers, Katarina Klaric, said: “Once a patent is granted, the patent owner has a monopoly in respect of the invention, that is the exclusive commercial rights to exploit the invention the subject of the patent.
“This means that the patent owner can take legal action to stop others from manufacturing, marketing, distributing, selling or otherwise commercially exploiting the invention.”
There are considerable commercial benefits in having a patent because of the monopoly rights granted, she said.
“Monopoly rights enable patent owners to recoup some of the substantial investment made in research and development and clinical trial to get a drug to market.”
Conflict of interest questions
On Wednesday, six days after Guardian Australia issued Borody with a series of questions asking about the patent and the extent to which he had declared the apparent conflict of interest, Topelia Australia issued a press release – months after the patent was filed – announcing it had “secured exclusive global patent rights to Covid-19 Antiviral Triple Therapy from Prof Thomas Borody”. The treatment, trademarked as Ziverdox, is a combination therapy including zinc, ivermectin and doxycycline.
Through his lawyer, Borody said although Covid-19 treatment patents had been filed under Borody’s name, those applications and the patents once granted are owned by Topelia Australia.
“There is no guarantee that Topelia will make any money from its patents such is the nature of the commercialisation and development of new pharmaceutical drugs, as well as the pharmaceutical industry,” Borody’s lawyer said.
An Australian Securities and Investments Commission search shows Borody is both the director and secretary of Topelia Australia. The address listed is the Centre for Digestive Diseases. According to the Topelia Australia press release issued this week, the company is hoping to raise $25m from investors in its bid to gain TGA approval, conduct clinical trials and eventually commercialise the treatment.
The president of the Australian Medical Association, Dr Omar Khorshid, said Borody should declare the relevant patent when promoting his Covid-19 triple therapy. “Any doctor who is advocating to government or to a regulator for approval of a new treatment would of course have to declare their interest in that,” he said.
“It is a direct conflict of interest. The extent of your conflict has to be declared, not just that there is one, but you have to declare how big it is. Is it a financial one? Are you being paid? Do you have a commercial relationship, do your family members have one?
“And I think we have an obligation also to disclose to our individual patients if we have some kind of financial interest in our treatment that we’re providing or promoting. That’s all part of normal business as usual for the medical profession.”
In a statement to the Guardian sent via lawyers, Borody denied that he had “done anything wrong or illegal when advocating for the repurposing of existing medicines to treat Covid-19”.
“My client has never hidden the fact that he applied for patents over his Covid-19 treatment. That is a matter of public record for some time now. It is self-evident that if a prolific inventor, such as Dr Borody, is advocating the use of his Covid-19 treatment, then he is likely to have a financial interest in that treatment.
“He is a responsible doctor who holds himself to the highest standards in medical practice and research. He is a strong believer in fairness and equity. He is not afraid to challenge medical orthodoxy based on his evidence-based medical research.
“It is silly to allege that my client has an obligation to disclose his financial interest in his treatment when dealing with the federal health minister, members of parliament and others, [or in media appearances and interviews] when he is approaching them on the basis that: (a) he is a medical specialist who has invented his own Covid-19 treatment based on repurposed existing medicines; and (b) his reputation as a medical inventor speaks for itself …
“He shared his Covid-19 therapy for free with other Australian general practitioners who requested it. It was not illegal then, and it is not illegal now, for my client to have shared his protocol with Australian general practitioners who wanted it.”