A Plate of the Good, the Bad, and the Ugly

Tomorrow on 19 September 2010, the FDA’s Veterinary Medicine Advisory Committee will discuss and evaluate the safety, effectiveness, and environmental impact on the first genetically engineered (GE) Atlantic salmon called AquAdvantage from AquaBounty Technologies Inc. based in Waltham, MA.  So far, major news sources reported in an optimistic tone that AquAdvantage will receive recommendation from the panel.

Good: A New Biotechnology Makes Salmons Grow Bigger and Faster

With increasing growth of human population and unpredictable natural disasters on earth, there is an awareness of possible depletion of food source from the land and the sea in the future.  Since the inception of the recombinant DNA technology in the 70s, its variety of applications has benefited many industries like medicine, agriculture, and science, with humans being the biggest beneficiaries.  AquaBounty introduced a single copy of a continuously expressing growth hormone transgene into a salmon egg to produce triploid hemizygous all-female Atlantic salmon (Salmo salar).  Therefore, growth hormone was produced all year round, boosting the growth rate and mass of the GE salmons.  To ultimately resolve the decrement of naturally produced seafood, genetically engineered animals could offer a hope and solution.

Bad: Competition Between Nature vs Man-made

From the business point of view, for those whose livelihood rely on what the ocean can offer are concerning the competition brought by man-made fish, theoretically unlimited supply.

Ugly: We Don’t Know What We Don’t Know About GM Food

Speaking of genetically modified (GM) food, several of my colleagues reacted with doubts of potential unknown harm to the human population and environment.  Although there are strict FDA regulations of where and how the GE salmons can be cultured and distributed, a Nature News reader, Anurag Chaurasia of the National Bureau of Agriculturally Important Microorganisms in India, suggests:

“FDA should conduct SAFOTEST (by feeding GM fish to experimental animals) for few years followed by voluntary human trial before giving OK to transgenic fish.  There are always chance of cross breeding between GM & wild fish.  More ever in biology it is not always 1+1=2, some may not be triploid.  FDA should not be in a hurry in such sensitive issue otherwise GMOs like opposition may have to be faced.”

There are also other concerns about food allergy or increased cancer risk from consuming a large amount of GE food.  So the post-market data collection and analysis has to be implemented to allow us understand the potential hazard (or lack of) of GE food.

Until next post, keep on reading and writing!!

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Take a Thrill Ride of the FDA Advisory Panel’s Decision

Gambling on FDA Advisory Panel Decision?

I recently encountered a short article on how to use FDA’s advisory panel to trade stocks. The article caught my eyes because I am really curious about how Wall Street plays games using FDA.

Pump and Dump Prelude?

My case-in-point is VIVUS, a biopharmaceuticals company whose weight management drug QNEXA (phentermine/topiramate) faced the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee’s vote whether it can go on market on July 15.  On July 13’s Wall Street Journal, a report “FDA Finds ‘Significant’ Weight Loss With Qnexa” and New York Times’s “F.D.A. Review of Diet Pill Relieves Investors” both had positive outlooks for QNEXA to pass panel vote to go on market.  And Leerink Swann analyst Steve Yoo told Reuters, “The topics the FDA raised are in line with what we expected,” and he said “the likelihood of a positive panel vote has increased, which in turn increases the likelihood of approval.”  Three major news sources were upbeat about QNEXA’s clinical trial results.

Science Speaks Louder

To give myself a benefit of doubt, I went to FDA’s website to download over 200 pages document.  I have to admit that I am not experienced enough to make a judgement call, but there are many safety issues that seem to be not negligible.  On July 15, the FDA panel rejected QNEXA due to its questionable safety issues.  Admittedly, share price of VIVUS tanked during after hour trading.

What do I learn from this case?  Timing is everything and beware of analyst’s opinions.  Because some information may not be toxic on the surface, inside it can poison you if you don’t do your own due diligence and give a benefit of doubt on things you don’t really understand.  There are more cases you can practice as many drugs are waiting in line for FDA advisory panels’ examinations.

[Disclosure: I don’t own any of the stocks in the articles I provided the links to, and I don’t endorse any strategies of trading stocks.]

Until next post, keep on reading and writing!!