I am a senior investigator at NIH. That means I run a research lab of about 10 people, including students, some recent Ph.D.'s ("post-docs"), a technician. I share a secretary with another researcher. I spent about 15 years acquiring the skill necessary to do my job, including undergraduate college, medical school, graduate school (to obtain a Ph.D. in biomedical science), internship, residency, and postdoctoral fellowship. Like the vast majority of intramural NIH scientists, I do basic research on cellular processes. I get paid a fraction of what I could make as a practicing physician. I decided to work at the NIH because I enjoyed making fundamental discoveries of importance in science. Perhaps these discoveries will someday be used to understand medical diseases or even to develop cures. Surely, however, I do not work on developing cures. It may come as a surprise, but cures are developed in drug companies. NIH scientists like me, for the most part, simply discover basic knowledge.

I don't make any laws or regulate any industries. I don't control any research grants. I don't give out any contracts. I don't have any inside information. There is no way I can have a conflict of interest, unless perhaps a manufacturer of test tubes pays me off to purchase their brand instead of the next guys. (Haven't been approached so far.) Nevertheless -- to prevent conflicts which can't happen -- the new NIH ethics rules prohibit me from doing anything on my off time to supplement my salary and help pay my kid's tuition bills. They also prevent me from using my understanding as any physician would do to purchase medically-related stocks I think will appreciate.

Like the journalist who can't purchase stocks being reported on, NIH scientists like me shouldn't be able to purchase stocks of companies that they collaborate with or whose products they are testing.

However, journalists aren't restricted from purchasing all stocks. Similarly, it makes no sense -- and it simply isn't fair -- to require NIH scientists to divest holdings in a large portion of the economy.

So, at the end of the day there is a fundamental misunderstanding that has resulted in many column inches of misinformation and unnecessarily fuled the public outrage. You too seem to be woefully misinformed. (But, hey, if it sells books . . .) Let's get this straight: my job is NOT "coming up with causes and cures of disease." I do not work for a drug company. I -- like the majority of NIH scientists -- do basic research. We work very hard to come up with new knowledge that we publish in scientific journals. We hope that someday our research will find application, but we aren't in the business of making these applications, so we can't have a conflict of interest.

The attacks and the resulting nonsensical rules have had an impact, and you the public are paying the price. I can tell you, we scientists are demoralized. Instead of thinking about our experiments, we are getting angrier and angrier as we see the press destroying one of the most successful Government organizations. We will continue to get our salaries. But you will have created a severely debilitated and ineffectual NIH. Where will the basic science come from for the drug companies to create the cures of the future?

NIH Scientist raises three important questions that deserve answers.

First, my reading of the new rules do not prohibit you from investing in stocks, only in stocks of companies that may be affected by NIH's work. Even with an expansive definition that includes the entire health care sector, which is 15 percent of the overall economy, that still leaves 85 percent of the economy open to investment. I think the journalism analogy is still relevant. I wasn't prohibited from investing in all companies, only in those companies in the industries I covered. To this day, I do not invest in health care-related stocks because most of my writing is in this arena.

Second, the reason you get to work on basic cellular processes in your lab is because NIH's mission is to come up with the "causes and cures for disease" (Check out the NIH mission statement and the language of its Congressional authorizations). Sometimes that basic science is used by drug companies to develop new therapies; sometimes that knowledge is used by NIH scientists; sometimes it is used by someone at a non-profit drug developer who just happened to read about your discoveries in the medical literature. The histories of the NIH's war on cancer, the AIDS battles and the numerous rare disease breakthroughs by senior NIH researchers like Roscoe Brady are testimony to the fact that NIH over the years has been a major player in directed research campaigns that lead to breakthroughs -- not just basic research. If you get out from behind your tree and look at the whole forest, I think you might begin to see the wisdom of NIH scientists -- even basic scientists like yourself -- not playing favorites among private sector firms or putting on the blinkers of private consultantcies when some company wants to make use of your knowledge.

Finally, you complain about your relatively low salary compared to colleagues in private practice. I agree wholeheartedly. Far too much attention has been paid in the press to the very high salaries of a handful of senior NIH researchers, and too little attention paid to the average salaries of the rank-and-file scientists who are doing the creative work. The cause of medical innovation would be better served by putting more money into your basic salary than by having you earn it by moonlighting for drug companies.

I am pleased to be able to continue this public dialog. NIH scientists, perhaps out of complacency or perhaps fearing retaliation, have remained silent too long. There are many issues to discuss, and we’ll get to them in time. But for now, I want to address head on your dangerous misconception about the fundamental nature of the NIH intramural research program.

The long and short of it Mr. Goozner is that you get your information from the NIH web site. I -- on the other hand -- know the reality from having worked on the Bethesda campus since 1981. I started as a post-doc and I have worked my way up to lab chief. I am now a senior investigator. From my perch at the top of the organizational chart, I can see the forest very clearly.

The truth is that NIH is not organized to find causes and cures. But it is not at all surprising that you have been deluded into thinking otherwise. Yes, the mission statement is right there on the NIH web site. The Congressional appropriation language says it too. Where do the Congressional staffers get the wording? Why, from the legions of NIH staff whose job is to act as PR agents in offices of communication and science policy that are found in the Director’s office and throughout the various component instututes. (Have these people ever bothered to ask me what I REALLY do? Don’t ask; you don’t want to know the answer.) These good folk are paid to justify the existence of NIH and they do their jobs very well. Unfortunately, Congress has been sold a bill of goods, and now it is coming back to haunt the NIH in terrible way.

The simple reality: NIH is not set up to create cures.

If you want to create cures, you need to have expert chemists who can make drugs. Well, guess what? -- We had a few when I started at the NIH, but most of them retired. There aren’t any medicinal chemists to speak of here now and there is no way I can tap into the one or two that are left; they have their own research interests. (Big drug companies have hundreds of chemists that work closely with scientists.) You also need people who understand how to do molecular optimization, pharmacological and toxicological testing in animals, pharmacokinetic studies, ADME (adsorption, distribution, metabolism, excretion), and phase I studies in normal volunteers; you need experts in clinical trial design, and you need people with the expertise to deal with the FDA. People with these kinds of expertises aren’t available to NIH scientists. Most importantly, you need huge amounts of money to run clinical trials that can run into millions upon millions of dollars. My research budget is about $1 million. If I should happen by chance to discover a new drug (I’m not looking for one), there is absolutely no way I can afford to carry out the research to make it a reality for patients. Moreover, the incentives here are not to develop new drugs but to do great science. Virtually nobody I know is trying to invent drugs. That is the business of the pharmaceutical industry. NIH is not organized to discover drugs and NIH scientists don’t have the resources to develop drugs. (And most sensible people wouldn’t want to try to turn NIH into a drug company; there are plenty of drug companies and only one NIH.)

You say drugs are old hat –- biological cures like enzymes (see Roscoe Brady below), peptides, antibodies, gene therapy –- even stem cells -- are the way of the future. Unfortunately, the same issues apply and it is even more difficult to develop a biological remedy.

There are a just enough cases where NIH research has been spun off into cures to keep the journalistic printing presses running full bore with delusions and fantasies. Roscoe Brady’s work on Gaucher’s disease – an exceedingly rare condition – is one of these. (Of course, it took Genzyme Corp. to make the therapy he pioneered a reality for patients.) However, to extrapolate from these examples, which you can perhaps count on the fingers of one hand over the entire history of NIH, is a gross misrepresentation. There are about 2500 M.D. or Ph.D. scientists at the NIH right now. We are doing basic research – not developing cures. But, no matter, what we are doing is a good for America and humanity. We are building the infrastructure upon which we hope the cures of the future will be built.

It should now be obvious that permitting companies to tap the expertise of NIH scientists through consulting arrangements is by and large not at all problematic from a conflict of interest point of view. For the most part, we can't benefit improperly or misuse our Government positions to aid private industry. Later, I’ll explain why these consulting arrangements can, in fact, be a very good thing if you REALLY want to accelerate the development of cures. Not only is there no wisdom to putting blanket restrictions on these activities, it is highly counterproductive for lots of reasons. The reasons are not all so easy to understand when you are outside the NIH and not in the trenches of science. But that is another discussion . . .

Our differences, NIH Scientist, are not as great as you think.

I recognize that the vast majority of work on the NIH campus is comparable to the 80 percent of NIH funding that goes out to universities in grants. It is for basic research into the causes of disease, not applied research to develop cures.

However, I think you underplay the historic role that NIH’s “directed research” campaigns have played in combating specific problems. The $50 billion spent by the government on the War on Cancer over the past 30 years has always had a large component directed at every phase of the drug development process. The modern tools of research and development would have been impossible without massive infusions of federal funds. The government role even extends to clinical trials – the most expensive part of the drug development process. Where would the war on AIDS or cancer be without the AIDS Clinical Trial Group or the 15 or so cancer clinical trials networks around the country?

Well, now I think we are getting somewhere. You point out that 80% of the research on the NIH campus is basic research, similar to that done at universities, medical schools, and research institutes. I don’t know that this number is correct, but let’s say for arguments sake that it is. Then why on earth do you want to subject those of us who are in the 80% majority to unnecessary, super-strict restrictions on stock ownership and limit our ability to consult? (Of course, those relatively few NIH scientists who are running clinical trials, handing out grants and contracts, or working in their official capacities with companies will obviously need to accept such limitations.)

You say government workers need to be held to a higher standard and be paragons of virtue and propriety. (You mean it is not virtuous in America to be an entrepreneur and attempt to better your family financially by working extra hard nights and weekends?) Well, there are several reasons why it is very bad for NIH and for America to impose severe consulting restrictions on all NIH scientists willy-nilly.

First, it is bad for morale and recruiting. We NIH researchers function in a community of scholars. Our colleagues and peers are university professors. University professors are generally not restricted from owning stock (unless, of course, it represents a conflict of interest, such as if the professor is conducting human clinical trials on a drug under development by the issuer). University professors are generally permitted to engage in consulting, although they often must have the arrangements reviewed. Restrictions that are more severe than those that apply to university professors are not only unnecessary, they turn NIH scientists into second class citizens in the community of science. This makes us demoralized and unwilling to devote the enormous effort that it takes to do ground-breaking scientific research. The best people don’t want to stay here and it’s impossible to recruit the most outstanding people. You are left with a bunch of mediocre plodders. Is this what the public really wants for NIH?

Second, consulting with industry makes NIH scientists better at what they do for NIH. They learn an enormous amount and the general understanding of the “real world” informs their science.

Third, consulting is one of the few ways NIH scientists can directly promote the search for cures. You are completely correct – the new rules don’t prevent NIH scientists from engaging in officially sanctioned collaborations with industry (referred to as CRADAs). Well, in most cases, a CRADA isn’t what a company wants. A CRADA is a collaboration where some of the research is done at NIH. Only companies operating on a shoestring need this. Any half-decent company has its own labs where it can control the research and, most importantly, the information flow. What companies REALLY want is to borrow the brain of a bright NIH scientist to give them advice on a problem they are grappling with. Now, Mr. Gloozner this is important, so listen up: every time a company taps the brain of an NIH scientist it has the potential to get the company CLOSER TO A CURE. Even though most of us don’t create cures in our NIH labs, our knowledge can help companies do it. Companies can surely read our published work in journals, but we can’t help them solve specific (and very confidential) problems unless consulting is permitted. If you stop NIH scientists from consulting with industry, you cut-off access to the intelligence of NIH scientists that can help companies develop new drugs and other kinds of treatments. If makes no sense to stop consulting when there is no possibility of a conflict of interest. If you do, you weaken NIH. You also deprive industry of the expertise of NIH scientists.

By the way, I have had CRADAs and you wouldn’t believe the restrictions and red tape that they require – concerns over intellectual property, confidentiality, publishing, appropriate contribution of the company (the rules say a company can't just contribute money) and so forth. There are too many government rules to make it a good deal for companies in most cases. Also, companies are frightened like the dickens of working with NIH on any official basis. They are worried that Congress will one day tell them how much they can charge for a drug if word gets out that NIH participated in even a tiny part of the research.