David versus Goliath:
National Cancer Institute (NCI) Small Business
Innovation Research (SBIR) Database Phase II Contract
— What if…?
It was in 1985, while I was having dinner when a former colleague from Franklin Institute of Philadelphia, Bernie Epstein, called. We both had worked on a project with NCI on some international cancer database a year or two earlier. Now, he was working for Ketron, a small computer database company not far from Philadelphia. He was in charge of grant writing and routinely reviewed publications announcing requests for proposals (RFP’s) from the National Institutes of Health (NIH) and other government agencies. He saw one from the NCI on building a computer database for medicinal plants with antitumor activities, basically saying the jungles were disappearing and we needed to document as many of these plants with antitumor activities as possible before they were lost forever. There was nothing about finding antitumor plants from traditional medicines such as Chinese or Indian. I told Bernie that I had no experience with jungle medicine nor did I believe it to be that worthwhile.
Then, after dinner and overnight, a thought came to me. Why go to the jungle? Doing that might be glamorous and ‘sexy’ compared to the dull task of investigating established traditional medicines like Chinese medicine. But in Chinese herbal medicine, there were already more than 10,000 herbal drugs documented. Among them, one could find many with antitumor activities if one knew how to interpret the Chinese medicinal records. And I specialized in recognizing potential new active chemicals for use in drugs and cosmetics from traditional Chinese herbs. So I called Bernie the next day to tell him about my idea, which was to deviate from the requirements of the original RFP. Instead of concentrating on jungle medicines, we would emphasize traditional Chinese herbs with their rich history most of which has already been well documented. While the original RFP had jungle medicines as the priority, with systematic traditional medicines only as a minor topic, our proposal stressed Chinese herbs, with traditional medicines of other countries (including jungle medicines) as a minor concern. For the non-Chinese botanical areas, I was able to persuade Dr. Richard Evans Schultes of Harvard University to be one of our three consultants, the others being Dr. James Duke of the U.S. Agricultural Research Services, also a well-known botanist and author, and Dr. Ara Der Marderosian, Professor of Pharmacognosy at the Massachusetts College of Pharmacy. Dr. Schultes is generally considered to be the father of Ethnobotany, a field based on the use of medicinal plants by native peoples. Since I was going to be the Principal Investigator, my company (AYSL Corp.) was the intended contractor and Bernie’s employer, Ketron, Inc., was the subcontractor. We submitted our proposal and out of thirteen or so companies having submitted bids, my company and a company newly founded by Dr. Norman Farnsworth along with some of his associates and assistants, won the Phase I contract, each of $50,000. Dr. Farnsworth was probably the biggest name in pharmacognosy during the past several decades. He was well connected to NCI and other government agencies. I wouldn’t be surprised if he or an associate or assistant had persuaded NCI to put out that RFP so that his group could form a private company to take advantage of the database, NAPRALERT, that was well known worldwide. This database had been built by Dr. Farnsworth’s group with government funds over a period of more than a decade. I believe they had expected that they would get the NCI SBIR contract. A tell-tail sign was in the wording of the RFP announcement. The qualifications of the applicant-candidate fit him and his group perfectly. Nevertheless, Dr. Farnsworth himself was not on the proposal.
While I had research and innovation experiences, my qualifications and those stated in the RFP didn’t match for the most part. But the reviewers must have liked our proposal and my approach along with my Chinese herbal resources, otherwise they wouldn’t have awarded us one of the two winning Phase I contracts, especially as our research focus was not even what the RFP specified. The Phase I contract was a proof-of-concept endeavor and would last six months, I think. Then both companies would demonstrate their products at NCI headquarters and if acceptable, would be invited to submit a Phase II proposal. The winner of that Phase II proposal would be awarded a contract worth $1 million to build and commercialize the database. Consequently, we both submitted our proposals. Normally, the decision of which company would be the winner after submission of the proposals would take about nine months. But in our case, a year passed without any notification. Then, more months elapsed and still no word. When I called NCI, I got conflicting responses, from ‘not ready’ to ‘both proposals were recommended for funding.’ I had never heard of such a thing. I always thought that whoever won the competition would get the contract, not both. I became impatient and suspicious. Finally, I got fed up and wrote to my Congresswoman, Marge Roukema, of Bergen County, New Jersey. After some time, I got the response that I wouldn’t have gotten if I had not been so upset that I had written to my congresswoman (Marge) who also happened to be a close friend of our close friends, Drs. Raul and Alba Ludmer, and whose husband, Dr. Richard Roukema and Raul were both psychiatrists and practiced in the same building in Ridgewood, N.J. The letter from the Department of Human Health and Services was signed by Robert E. Windom, M.D., Assistant Secretary for Health, telling us that AYSL Corporation had basically won the competition, “… Dr. Leung’s proposal received a score of 770, with 1,000 being the maximum possible number of points, and was the higher ranked proposal. The program staff recommended that this proposal be considered for funding in that scientific area, an indication that the AYSL proposal is of value….”
The knowledge we had beaten a monolithic organization was a consolation prize for me, though without the Phase II contract. I often wonder if I would have ever received any response from anyone if I had not been mad enough that I had, for the first time, utilized my personal connection with our congresswoman. I also contacted our senator, Frank Lautenberg, at the same time, but I don’t remember if he even acknowledged my letter. But if he did, it would have been an unmemorable form letter from a staff member. One of my major social handicaps is that I have never learned how to use personal or business connections for my own benefits, which I have always felt gauche, coming from me. Asking Congresswoman Roukema to write that letter was one of the two or three times I have used personal connections for my own gains. Another was when I asked one of my father’s prominent friends in Hong Kong, Dr. Ambrose So (see Chapter 1: Growing up in Asia) to help me present a proposal to the Hong Kong government for forming an international consortium to properly modernize Chinese medicines in the early 2000’s. That failed due to the entrenched drug-development and drug-therapy system that for decades had a solid grip on modern (aka American) health care concentrating on modern toxic chemical drugs.
In any case, Dr. Farnsworth was bigger than life for his graduates and most people in the pharmacognosy, natural products, and medicinal chemistry fields. Almost everyone knew him. He was quite a character, often made crude jokes to see the reaction of his listeners. I respected him and he seemed to respect me because he was always courteous to me even though I was quite a few years younger. We never collaborated in our work, but were once together on the same committee for setting botanical standards which he chaired. However, that was finally dissolved without accomplishing anything like many such committees. I remember fondly at an American Society of Pharmacognosy annual meeting in Storrs, Connecticut in the mid-1970’s, we were in a poker game together with Dr. Gordon Svoboda (the one who developed the anti-leukemia drugs from Vinca alkaloids at Eli Lilly) and one other colleague whose name I can’t recall. Norm told a lot of jokes and we all drank, though I barely (maybe up to a half glass), as I was not a drinker. My wife has tried for forty years to get me finally to drink up to one glass of wine without beginning to talk to a houseplant. Now, I can honestly tell others that my wife is probably the only woman in America who encourages her husband to drink more. Anyway, I cleaned them out that night and was being teased about my being a beginner at the game. But honestly, it was the first time I played poker with friends for real money (meaning not play money). That night’s take was probably no more than 20 or 30 dollars. Nevertheless, for quite a while I was teased as being a cardsharp.
Norm and my thesis advisor, Dr. Ara G. Paul (later Pharmacy Dean), and Dr. Varro E. Tyler, Jr. (who wrote the “Honest Herbal”) were peers. He was from the Massachusetts ‘school’ trained under Dr. Herber Youngken, Jr. while Drs. Paul and Tyler were trained under Dr. Arthur Schwarting in Connecticut. After I found out I had won the NCI contract bid, though without the money, at first I was very satisfied and proud about it – to have beaten the best team in its own game. But then, I felt badly about letting down a bunch of young researchers and staff under Norm’s organization, because earlier at a meeting in Chicago I had met one of Norm’s staff and learned that she chipped in to found Naprotech to respond to the RFP. I would have liked to collaborate with Dr. Farnsworth while he was alive. But because I didn’t know how or liked to schmooze with others, I never tried with Norm. It’s what I call it my social handicap. On the other hand, I wouldn’t feel badly breaking up a ‘scam’ if the RFP indeed originated from a buddy system between government and academia that favors Norm’s group. After all, Norm knew all NCI’s key people. After his death a number of years ago, the natural products database NAPRALERT continues to be dominated by Norm’s group and his influence – geared mainly to chemistry with no provisions for traditional medicines other than using them as raw material sources to discover and develop new chemical drugs, leaving the huge resources of systematic traditional medicines (with actual human-use experiences) untouched except exploited as source of chemicals to be turned into new chemical drugs. Their true value has never been properly tested even up to this day!
In the last few years, the topic of cronyism among academic and government institutions has at times popped up. To me, although Dr. Farnsworth’s group has dominated the ‘natural products’ field (especially database) for over forty years, it seemed obvious there were scientists out there who thought my alternative
idea was good and deserved funding, as both Phase I and Phase II reviewers liked our proposals and would have funded our Phase II research also. But it was also obvious that that project was not meant for me. Can you imagine if Norm’s group had a higher ranked proposal than mine and his was recommended for funding and NCI didn’t fund it, saying that there were not enough funds to go around?
After having been in this diversified field for over fifty years and seen practically
everything, including ‘empire building’ in academia and the ‘revolving door’ between government and industry, I don’t think this whole episode of the NCI database contract was totally free of cronyism.
That happened thirty years ago. There were already scientists in the natural product and health fields who would have liked to see more diversity in the technologies used in these fields. The idea that there is (should be) only one type of easily identified and analyzed drugs available, which invariably would end up toxic, did not sit well with them. It seems obvious there were enough reviewers of our proposals, that liked to see changes in these fields, and saw potential in my approach, even though it was not the original theme of the RFP. On looking back, it has been over thirty years since NCI rejected our alternative route (if not new direction) in our natural drug therapy, and 45 years since President Richard Nixon declared war on cancer. In that time, I don’t see anything new that has materialized other than maintaining the status quo of toxic drugs begetting new diseases that require more of the same.
Isn’t it time to give new ideas like mine another try?