The Questionable Ethics of Anisina – Part II

I have lost a lot of sleep this week about my prior post on the relationship between Novogen/Anisina (ASX : NRT) and the Kids’ Cancer Project. I received some fairly scathing emails from donors who are obviously very passionate about what the Kids’ Cancer Project represents and – if I am honest with you – rightly so. It’s one thing to pick on companies that lack integrity, it’s another thing to target charitable organisations that are simply trying to improve the standard of care for our loved ones.

For example, the mission statement of the Kids’ Cancer Project:

Laudable... but...?

Laudable… but…?

Unfortunately, when one considers the efficacy of the biosciences landscape in Australia, companies are not the only “ecosystem” stakeholder contributing to our overall mediocrity. Government policy, private investment ethos, insular academic standards and culture, and the non-profit arena all contribute to many of the problems that we have to fix if we want to be respected on the global stage for our innovation output. For close to a decade now I have been a strong advocate of private-public partnerships to tackle some of our biggest social challenges, but when there is exploitation and a lack of transparency in the interface between business and the public wallet, things can go very badly wrong.

I am impressed with the mission of the Kids’ Cancer Project, but less impressed with the execution. If you read the 2013* and 2014 annual report for this charitable organisation, you get the picture that this is an organisation that has basically had a fairly static research funding deployment plan over the past three years. I have put together a consolidated picture from the various annual reports:

Kids cancer research expenditure

There are a few things that should jump out at you. Firstly, extrapolating from the 2011 annual report (which provides more descriptive detail around the individual programs than do subsequent reports) the single largest expenditure is Peter Gunning’s neuroblastoma drug discovery program at UNSW. Add to that the additional related line items for related anti-tropomyosin drug development, and it’s over a $1m / year or almost 1/3 of the total funding of the charity. Therefore I think it’s fair to say that Gunning’s work is the “flagship” investment, and this is certainly reflected in the charity’s web site, in my opinion.

The second interesting thing is that 1/3 of all research expenditure goes to UNSW programs, and a further 1/3 of research expenditure goes to programs at the Westmead Hospital, a UNSW-affiliated hospital. This begs the question of how Professor Peter Smith, the Dean of Medicine at UNSW and Chair of the charity’s Research Advisory Committee (RAC) isn’t conflicted? Moreover, Prof. Smith has previously publicly endorsed the anti-tropomyocin work, so this is not only a flagship program for the charity, but it is a flagship program for UNSW’s cancer program. Such endorsement is not overly surprising given Prof. Peter Gunning’s seniority in the program (i.e. the head). You might also note, if you were a cynic, that the charity hasn’t particularly changed its funding allocation the past few years, but yet “research governance” expenditure (presumably the cost of running the RAC) has tripled. Donors should certainly want to understand the reason for this.

The third interesting thing is that Nationwide Children’s hospital also got $250,000 from The Kids’ Cancer Project over the past three years for testing new neuroblastoma drugs. Back in July we saw an announcement from Novogen that Anisina had been shown to be effective in pre-clinical studies in neuroblastoma, conducted at Nationwide Children’s Hospital. To be clear, this isn’t a hospital in Australia – it’s a hospital in the US (Columbus, OH), and a collaborator site of Novogen’s (part of CODA). I also note that if you take another look at the charity’s RAC you will note that Dr. Timothy Cripefrom Nationwide, sits on the committee. So I guess that’s how it works – sit on the charity’s medical advisory board and then just redirect the funding to your own institution? That’s nice and simple! Frankly, knowing the extensive capabilities we have to conduct pre-clinical research of this nature in Australia, I am disappointed that Australian donor money went to running a bunch of mediocre experiments at a US institution, but there you have it.

The Kids’ Cancer Project is – on the whole – not the most efficient charitable organisation, mostly reflective of the fact that its fundraising mechanisms have a fairly high cost-of-goods (raffles, merchandising and the like). A relatively small proportion of the charity’s income makes it into research (again, not implying anything inappropriate, except maybe the increased “research governance expense” and the utter lack of impartiality of the RAC), but what does make it into research is highly aligned with UNSW’s cancer research program, Peter Gunning and … Novogen/CODA. In fact in the last three years, at least 36% of The Kids’ Cancer Project or ~$3,250,000 of funding has gone into programs that directly benefit the intellectual property portfolio owned by Novogen and almost $7m in total to affiliated research institutions.

Put another way – 74% of all donor money in the past three years, allocated for research by The Kids’ Cancer Project, went to institutions affiliated with Novogen/CODA, and at least 40% of research allocation in the past three years has benefited the development of technology owned by Novogen. There is no clear disclosure of this, at least not that I have been able to ascertain, in any of the annual reports.

But who cares? Surely it’s perfectly reasonable for a charitable research organisation to direct its funding at anything it (or its RAC) can justify?

Well, I suppose that’s true but you would have thought that before the charity started reaching out to donors to fund a trial at Westmead for Anisina, it would have properly managed it disclosure with respect to Novogen. I wish to acknowledge (with appreciation) that since my last post, the charity has updated its web site (see before), but justification for supporting this research has to go much further than just disclosure of a highly conflicted commercial relationship. To repeat, I have no problems with companies and charities working together to achieve good outcomes for patients, but when yet more donor money is solicited to cover the clinical development costs of a drug that is owned by an ASX-listed company, then I strongly believe that much more explanation and rationale is required. Also, if this level of funding continues to be directed towards UNSW, then the governance structure of the RAC also needs to be urgently reconsidered. There are plenty of other highly qualified oncologists and medical administrators in Australia that can be recruited to do the job.

To conclude, on a slightly unsatisfactory note, there are still many questions that need answering…

  • Why, given at least $4m (including 2011 dollars) in research funding and a $40m-ish balance sheet at Novogen (not to mention the fact that Genscreen/Trobio first initiated its commercial relationship with the Gunning technology in 2005 (!!)) do we still have such a dearth of peer-reviewed data around this technology that demonstrates its potential efficacy and suitability for clinical translation? I’m not talking about the swath of basic science papers, of which there are plenty (of varying quality), I am talking about outcomes related to an identifiable drug candidate, outcomes that would genuinely warrant picking up the phone to potential donors to solicit funds for clinical translation.
  • Why, if Anisina (aka ATM-3507) is purportedly so effective (and potentially pan-cancer), is Novogen not “all over it”, especially since Westmead and UNSW is clearly getting a pile of related funding and there should be no impediment to clinical translation, at least from a financial standpoint. Not to mention Novogen’s decent balance sheet.
  • Why, if Anisina truly is a robust clinical candidate (and has been a clinical candidate since at least late year) do we still continue to get these underwhelming pre-clinical updates on science that should have easily been accomplished by now with all that money granted from The Kids’ Cancer Project donations? Indeed a significant amount of those “studies” (for example Anisina announcements back in MarchMay, July) were conducted in the academic setting using that money, not Novogen’s money. Yet Novogen clearly felt that those Anisina announcements were important – even price sensitive (they were disclosed as such to the ASX).
  • Why, if Anisina is a flagship product, did the company make a press release earlier this week “confirming mechanism of action” (strangely, not a price-sensitive ASX disclosure like all the other underwhelming pre-clinical announcements that Novogen makes and not even a press release, just a quiet posting to the news page) for the anti-tropomyosin technology? Not only did this strange disclosure “confirm” mechanism of action more than a decade after Trobio Pty Ltd was formed. Not only after millions of dollars of donor money from the Kids’ Cancer Project has been spent. Not only after the company has repeatedly asserted that Anisina is a shining light in the world of cancer. Not only after Novogen raised a huge amount of money to develop the program. But now?
  • Why would Iain Ross talk about an optimised GLP/GMP process for making Anisina back in July (with GMP production to have commenced in August) without having firstly disclosed basic toxicology data for the clinical candidate? What sort of a company invests in the expense of GMP scale-up for clinical trial material without reasonably understanding 1) the mechanism of action and 2) any meaningful toxicology data for the drug? I’m not talking about GLP toxicology for an IND package, I’m talking about just basic candidate selection / justification on the basis of toxicity?

The bottom line is that this drug, this company and its relationship with The Kids’ Cancer Project is all a bit stinky. There are too many unanswered questions and not enough transparency. It is not my desire to hurt the Kids’ Cancer Project because I feel strongly that it is critically important for us to continue to support important research into cancer. However when charities and companies take money from the public, either through donations or shareholding, they have a duty to demonstrate transparency and integrity.

When companies and charities work together, this duty only increases.


 

*Includes 2012 numbers for comparison in the 2013 report

10 thoughts on “The Questionable Ethics of Anisina – Part II

  1. This is quite troubling. Have you considered providing the affected parties with the right-of-reply with an unedited guest post? They will probably refuse but it seems reasonable to give them the opportunity.

    Like

      • Uncomfortable reading Chris but I cannot fault what’s been said – doesn’t mean they necessarily set out to not properly acknowledge the relationship with Novogen. It needed to be corrected – Novogen aren’t a charity especially the recently departed he was very well compensated during his time there.

        Like

      • Sad but true. This charity needs to have very real rethink about who it is and what it’s deliverables are.

        I feel particularly bad because September is children’s cancer month. Perhaps a donation to the Peter Mac will restore the karmic balance.

        But probably not 😦

        Like

  2. Chris this reminds me of when the Chasers war on everything did a comedy spoof on the childrens make a “realistic” wish foundation; because they were going to die anyway.

    The chasers karmic forces took a serious dent.

    But your right the foundation should really be perfectly clear about who they support, why and what they hope they to achieve. Unfortunately often the sales pitches for these sorts of charitable bodies are put together by PR guys or communication specialists. Who are just not into nuances around research governance.

    I just skimmed through the web-site of a significant foundation based in a major teaching hospital from which I have received a few small grants. It is truly woeful; outdated, overstated, selective and jingoistic.

    So keep calling it as you see it; but I’d avoid doing any research on Mother Teresa or Florence Nightingale for a couple of weeks at least.

    Like

  3. Chis

    A nicely presented analysis of the research foundation, and useful I am sure for other research foundations to learn from.

    Aside from the issues you raised I was struck by the level of funding for neuroblastoma related research. That may reflect the foundations perception of need, but with other malignancies being more common

    http://www.cancer.org/cancer/cancerinchildren/detailedguide/cancer-in-children-types-of-childhood-cancers

    i.e Leukemias (30%), Brain and CNS tumours (26%), lymphoma (8%) ahead of neuroblastoma (6%), it raises a question of why?

    Perhaps it is because:
    1) there is some overlap of the other malignancies with adult research and they want to focus on tumours that dont get embraced by adult research, so with neuroblastomas being more restricted to childhood, they need the focus of funding.
    2) treatment outcomes are still so poor with neuroblastoma although the same could be said for many of the brain tumours

    I was interested in the expenditure for research governance of 254K… There is separate funding for “Key Management Personnel Compensation” of 259K. The 254K may include some secretarial / admin support which would fit with the 92K figure the year before, but as you point out – that figure seems out of line for a presumably voluntary board, unless there are some site visits and flying in for meetings as opposed to teleconferencing in. I am assuming outside reviews of research applications are pro bono ?

    Any thoughts

    Like

    • Agree with you about the direction of funding…a little bit odd. If you look at the old site (links on my blog to PDFs) you will also note that the “facts” were somewhat over-sensationalised as well.

      My basic thesis is this isn’t a “real” charity anymore but has evolved into a vehicle being used to develop some particular research areas for some particular researchers.

      As to the issue of compensation for research governance I can imagine a bit of admin cost and, as you point out, travel is a possibility (including conference attendance on behalf of the charity). But I still struggle to get to 92k and, quite frankly, the RAC of a charity like this should be doing it for free. Especially given the fact that they didn’t actually make any real new research allocations anyhow.

      …and at the risk of sounding insular, there is also no need for two U.S. medics to sit on the board of an Australian charity (and presumably incur business class flights). We have plenty of people in this country that can competently allocate this money and deliver value to donors. Whether advising charities or doing pro bono work, medics and execs have an obligation to give back.

      Like

      • I can accept / understand some administrative cost – but not sure it is a full timer cost at 92K, and if part time then they are paying too much.

        The suspicion is that the additional cost of “research governance” is someone flying to look at the US site, or as you suggest US representatives flying in. If they have taken on a US hub for their trials in neuroblastoma then there are other ways to run a parallel program with a US site, assuming the drug warrants it, and that commercial interests are not being protected behind charitable programs.

        Like

  4. Pingback: A Little Rest | The Long Tail

Say something useful (or at least interesting)...

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s