Our social norms are, if nothing else, inconsistent. An alien race would look (is looking?) at our planet with confusion as it tries to decipher the complex algorithms of inequality, resource imbalance, discrimination and hypocrisy. It’s always amazing to see how as each new era of human existence supersedes the previous, what may have been considered heroic becomes shunned and unacceptable. Though in some ways, I still wish that cigarettes were widely considered to be a health remedy (my favorite cafe in Los Angeles has a pile of the old 1950s Marlboro posters where they tout “The Brand that 95% of Doctors Smoke”).
That’s the power of knowledge – it makes all things fun, bad*.The same applies to medicine. Plenty of physician scientists – Lister, Pasteur, Salk, Prichard, Hoffman, to name a few – experimented on themselves. Even our own Barry Marshall got the Nobel prize in 2005 for experimenting on himself with H. pylori. Obviously the science was pretty good, but the pioneering spirit is what made him famous. We love that stuff. Besides who wouldn’t take a drug after knowing that their doctor was so confident that they were willing to take it themselves. Marlboro and Camel ads from the 1950s illustrate this perfectly, and so do some of our biotech CEOs.
In response to prior posts about Graham Kelly, I had received a few critical / abusive emails about my comments regarding his self-experimentation. Over the last week I also received some similar argumentative communications about my comments in relation to Paradigm boss Paul Rennie’s “self-administration” (presumably someone at least medically qualified administered it to him) of pentosan polysulphate sodium for bone bruising. The general sentiment seems to be that people actually admire and appreciate drug company bosses that are willing to show this level of commitment to their technology. Indeed a typically “working man’s” review of Novogen in the Herald Sun gave a ‘speculative buy’ to Novogen on the basis that Graham Kelly had enough chutzpah and commitment to dose himself. Remarkable.
Well, I disagree and I’d like to suggest three very important reasons why that all shareholders should think carefully about :
1) Founders or CEOs that experiment on themselves are simply illustrating that they don’t understand what robust scientific data means in the commercial context. There is no doubt that the TGA, FDA and other regulatory agencies make life challenging for drug companies, some would certainly argue unnecessarily so. But then honestly when I take a step back and look at some the snake oil that certain firms are trying to peddle, I personally believe that a self-regulatory model will never work, even it it might theoretically enable important drugs to help patients sooner. We do formal and structured clinical trials for a reason – to make sure that there is some sort of a structured framework to regulate the quality and integrity of data that is used to induce both patient and investor behaviour. When it comes to doing a “proof-of-concept” in humans, which can be a defining event for many start-up companies, the truth is there is really very little excuse to do dodgy experiments. The CTN scheme in Australian (and many equivalent schemes internationally) enable a limited number of patients to be studied in a very cost-effective way. By the way, a CTN doesn’t stop data falsification, but at least it probably has a few more eyes looking at it than a CEO’s anecdotal claims of safety and efficacy.
2) Self-experimentation should suggest to shareholders that CEO is willing to take a disproportionate risk. In the case of Graham Kelly, if the guy was dying from cancer and everything else had failed, then I suppose it’s a reasonable personal decision to try something else, including your own drug. But then to stand in front of your prospective shareholder base and use your own heath as a product advocacy platform, is pretty unacceptable really. But at least GK was willing to disclose (nay grandstand) his actions to the public (I did a Google search on “CEO tests drug on himself” and GK is #1). I saw no evidence of any such public disclosure from Paul Rennie in the Paradigm prospectus which, in my opinion, illustrates a lack of business ethics because it deprives shareholders/investors of the ability to fully understand the risk profile of the person they are investing in. It also doesn’t disclose that there may be bias or even a basic lack of integrity with the data, because the conflict of interest between the CEO’s potential financial gain and the integrity of the data is not disclosed. Even worse, it is my understanding that Rennie’s self-administration was disclosed in private meetings with institutional investors but not in the public prospectus. That actually presents not only an ethical issue, but possibly a legal issue because of asymmetry of information.
3) The biggest issue, however, is not the ethics or optics of self-experimentation by company CEOs – but rather the decision bias. We do clinical trials precisely for the purpose of making objective decisions about how to pursue a product development and deploy shareholder capital appropriately to do so. It’s bad enough that we have plenty of examples of where management teams have just blindly ploughed ahead with very little reason for doing so, except to keep the gravy train running for a little longer. I would argue that Starpharma’s current Phase III study in R-BV is such an example where there is little clear clinical evidence to warrant spending $20m-odd of shareholder capital on another Phase III study. Invion’s recent announcement about their Phase II study in lupus is similarly flawed (I will be commenting on this study shortly). But when you see a CEO self-experiment, you know that this person has already made the decision that the drug is going to work, either because there is sufficient conviction to take a risk – or there is sufficient commitment to a financially successful outcome, however achieved, to be a willing guinea pig. Ultimately this means that as the leader of an enterprise, that particular individual is probably not capable of making objective and unbiased decisions about a drug.
That is why as an investor, I look very carefully at how clinical proof-of-concept data is obtained. I want to know whether there were any related parties, friends and family, etc. because it tells you a lot about a company. I’m not implying that it is always bad – I know of several CEOs that started companies to help a loved one. But self-experimentation without clear justification – and even worse, without disclosure?
*I should note for the record that I am a non-smoker, am not advocating to readers that they should have “fun” smoking and wholeheartedly accept all clinical evidence that it is extremely bad for you. Except maybe a Cuban with a glass of decent whiskey, once or twice a year. Unfortunately, I think I paid another 30 dollars a month for the mistake of making that disclosure on my life insurance premium, so it had better be a good Cuban.