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Monday, June 24, 2013

Breast Cancer Profiteer

I want to revisit the roots of this blog. What made me go crazy and start this thing? I make the claim that my biotech career resembled a Cargo Cult. We only pretended to do scientific research. Our hands were tied by the narratives of our leaders. Here is a specific example of a leader who defines Cargo Cult leadership.

Back in 2007 a little Cargo Cult company called Nastech was almost single handedly dismantled by the leadership of a megalomaniac CEO. Steven Quay can be heard here.

http://video.cnbc.com/gallery/?video=591437325

Nastech went on to tank, giving rise to MDRNA then Marina which is now a penny stock with one employee. Dr. Quay disappeared but came back with a new company Atossa. The company consists of a  breast cancer screening device that sucks fluid out of the breast through the nipple. The fluid is then sent off to test for breast cancer bio-markers. The FDA has a few things to say about the progress of the new company.

The warning letter from the FDA highlighted a few issues that resemble some of the observations I have made regarding Cargo Cult leaders. Take the first issue:


1.      Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, (b)(4), your firm’s Regulatory Consultant, indicated that you have not established design control procedures for the MASCT System.
 
We reviewed your firm’s response and conclude that it is not adequate.  While a procedure titled SOP-007, Design Control for the MASCT System was submitted in the response, no evidence of implementation or training on this procedure was provided. In addition, you did not provide evidence that you retrospectively reviewed all devices to ensure they had design control procedures in place as required for all devices.

When working for Dr. Quay it was clear that he had little interest in these kinds of details. He was a big picture kind of guy. Yet, as you can see, the very product that is intended to be sold seems to be an afterthought. Start company, get rich, design product as you go along. Maybe someday it will work as advertised. Which takes us to another claim from the warning letter:

Our inspection, and subsequent review of your websites www.atossagenetics.com and www.nrlbh.com determined that your devices are misbranded under Section 502(a) of the Act [21 U.S.C. 352(a)] and within the meaning of 21 CFR 807.97, in that your websites contain statements that create an impression of official approval of a device due to clearance of a premarket notification submission. 

Imagine trying to follow the "bend over backwards" kind of honesty depicted by Feynman while working for this individual. 

One humorous side story related to the FDA warning letter: Dr. Quay was once a heavy set man. He embarked on a weight loss plan that involved the use of Equal in his coffee. He was the only person to use the Equal because people were afraid of him and they didn't want to get caught using up all of the Equal. Dr. Quay used the opportunity to spread fear among his subordinates. He let the Equal run out. He immediately notified several C level executives and their direct reports. Meetings were held and plans were put in place and an SOP was written to ensure that Nastech never ran out of Equal again.

Which brings us back to what a Cargo Cult is. If the issue is about a product that is of value to the leader, that issue will be dealt with in great detail. Much ado will be made. But if the product is the cargo promised by the Cargo Cult, not much happens. The leaders don't need the product as much as they need the narrative. In this case, Atossa has what the FDA considers to be a fairly flawed breast cancer testing device. The understanding of what goes into such a company, (engineering and FDA regulation issues...) is about as complete as the understanding the Cargo Cults have regarding airports. 

We jokingly referred to the Equal incident as Equalgate. It became an example of the emphasis placed on silly things, while research projects received little attention. It is not surprising then for me to read the FDA warning letter and see that some things never change. Dr. Quay started a new company with a new narrative. The FDA pulled the curtain back on the Great Wizard of Atossa. Behind that curtain was a man who knew very little about his breast cancer product, but at one point in his career had an SOP written, distributed among the highest ranking members of his staff, and followed to the letter, so that he would not run out of Equal. It's not clear what motivates such a man but his tactics are predictable. There is little pride in the quality of the product but great pride in the power of running your own cult. 

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