Trust Me I’m A Doctor. A Perspective on the AOD-9604 cock-up

Investors in the biotech sector of the stock exchange will be well aware of the gap between  promotional spiel and profitable outcome for all stakeholders.

Although doctors may be altruistic and ethical, medical research is expensive, and they must build a valid case to raise enough venture capital on the stock market if they are to find solutions for serious untreatable illnesses or more effective measures than those now available.

Most biotech stocks will come eventually to bankruptcy, a few may become spectacularly successful. Hence biotech speculators will usually spread their risk across a basket of enterprises. It is just not possible to tell which companies will succeed.

Both medical researcher, and biotech company, share an irresistible need to provide a flow of positive announcements to support the share-price, and thus the flow of funds until their research is completed, and hopefully successful.

At times the need for a positive outcome colours  professional and corporate presentations to investors.

Regulators usually stipulate that new pharmaceutical products must undergo an exacting program of therapeutic testing to assess both safety and efficacy. It is a process that aspiring healthcare companies with promising products should navigate. However many unproven therapies enter the market without this scientific scrutiny, selling “over the counter” (OTC), directly to the public.

The Story of AOD-9604

Peptides are amino-acid chains, many derived from more complex proteins such as the human hormones. They have become latest glamour substances to be marketed in the pharmaceutical world for a whole universe of medical problems.

Many may eventually be found to be effective, their indications defined, and side effects shown. For others the results of trials will be negative or equivocal. For them the market itself is an alternative testing ground.

One such product is the now notorious peptide derived from human growth hormone AOD-9604. Biochemist, Professor Frank Ng, working at Monash University in the 1990’s is credited with developing this peptide, also known as Lipotropin, to find a product which was both catabolic (able to mobilize fat) and anabolic (able to build muscle).

Adelaide authority in obesity management, Professor Gary Wittert, after performing 5 of 6 studies on the product, believes that although it worked in mouse studies, it was ineffective in humans. These studies were carried out on 925 humans, and they established the safety of the product.

His studies were funded by Metabolic Pharmaceuticals, now a subsidiary of Calzada Pharmaceutical; it is listed on the Australian Stock Exchange, with the code CZD. They have spent $50 million since 1998 developing the drug.

In February 2011 in-vitro studies (ie in the laboratory) from Mt Sinai hospital in Toronto, Canada showed AOD-9604 stimulated bone formation in cell cultures using human mesenchymal (connective tissue) stem cells.  Further in-vitro testing on cartilage and muscle repair in March 2012 were also positive.

The company has been able to sell its product on an OTC basis to the veterinary, sports injury, health and body building communities, to recover its investment. It has recently achieved approval for marketing into the USA as a self-affirmed “Generally Recognized As Safe” (GRAS) product. The product is now legally sold in creams for the treatment of cellulite, added to foods and drinks, and available as dietary supplements, on the basis of promoting repair and growth.

The Essendon Football Saga

Sports Scientist Stephen Danks was appointed as an advisory sports scientist to the Essendon AFL club in 2012, and he set in motion a program of management involving the systematic administration of AOD-9604 to its players. He is the link between Calzada and Essendon.

The club maintains that it was duped by him to virtually conducting a clinical trial into its clinical efficacy.

ASADA (Australian Sports Anti-Doping Authority) is reported to have given unilateral approval to the club for its use, without assent from WADA (World Anti-Doping Agency). WADA is now adhering to its existing stated policy of banning all substances that might be Performance Enhancing, even if there is no current clinical proof.

It is likely that WADA will exercise is authority to ban all suspected substances, and to institute sanctions for violation of this code. Already Essendon is beginning to feel the effects of the continuing investigations, and is likely to incur heavy penalties in due course.

Who is to blame for this fiasco?

It is unfair to seek a scapegoat by identifying a single individual/group as responsible and to punish them alone.

Rather there is a chain  of responsibility extending back to the development research and the marketing of the product for financial gain, without proper clinical trials being carried out.

The Essendon Football Club is implicated too however. Their claim that they have been misled, may make them ‘bunnies’ but does not exonerate them from blame, since they would not have embarked on such an involved and risky program, had they not considered that it would result in enhanced performance as a team. They sought an advantage, that WADA does not allow. The team performance this year would suggest that the drug may be effective.

References

http://www.abc.net.au/news/2013-02-07/explaisubner-performance-enhancing-stances/450612

http://www.businessspectator.com.au/article/2013/7/17/gaming-and-racing/sports-drug-debacle-falls-asadas-shoulders

http://www.ironmagazineforums.com/research-chemicals/144568-aod9604-peptide-fat-lose.html

http://peptidetech.en.ec21.com/AOD9604_HGH_Fragment_176_191–4770502_4772465.html

http://www.smh.com.au/afl/afl-news/hird-sounded-out-last-year-about-peptide-investment-20130211-2e8yd.html

http://www.radioaustralia.net.au/international/2013-07-27/essendon-believes-club-players-were-deceived-into-taking-banned-drug/1167382

http://www.theaustralian.com.au/sport/nrl/stephen-danks-expertise-skill-knowledge-and-qualifications-beyond-reproach-lawyer/story-fnca0von-1226573927387

http://calzada.com.au/metabolic-pharmaceuticals-pty-ltd/

http://www.musculardevelopment.com/articles/fat-loss/2065-a-fat-trimming-fragment-of-growth-hormone.html

About Kenneth Robson

I studied at Adelaide Boys' High School, and the University of Adelaide, Medical School. graduating in 1961. My field of specialisation was Plastic and Reconstructive Surgery. Prior to establishing my practice in Adelaide, I spent 5 years working in India, and Papua-New Guinea, in the field of reconstructive surgery for leprosy. In retirement I joined the Australian Technical Analyst Association and passed the two examinations for a Diploma inTechnical Analysis, and the designation Certified Financial Technician (CFTe) by the International Federation of Technical Analysts.
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