California Expert Software

Introduction

NIH announced new rules for its scientists, aimed at reducing conflicts of interest in NIH research. According to the NY Times,

"An investigation by the agency concluded that 44 of its 1,200 senior scientists appeared to have violated rules governing consulting and that 9 might have violated criminal laws."

This is a long overdue crack-down on unethical and quasi-ethical practices in government sponsored research. Even though most scientists start out "honest," that character trait seems to diminsh with success ...

The temptation of huge amounts of money, of becoming permanently wealthy, is just too much for a lot of people. Many research workers rationalize "selling out" by thinking, 'when I'm rich, I will make it up by doing research on whatever I want.' Of course, it never works out that way, as the famous poem and opera Faust inform us. Once a scientist gives in to the blandishments of drug companies or Wall St investors, they find themselves on a treadmill. They are indeed well paid for their defection, but they are also on a short leash. Sometimes they end up like the unfortunate Dr Samuel Waksal, who's in jail even though his idea made a fortune for investors (except Martha Stewart) in ImClone.

t's very common for University research workers to leave the University to start their own companies just before they reach the pinnacle of their work, at the point when it becomes clear something will come of it, but before it is obvious to University Administrators. Almost all of their research work and their salaries are paid by Federal and State governments, so when they walk away with an invention or discovery that investment goes with them. It isn't foolproof, but some of the richest people in Biotechnology and Computing did their original work at Universities. Lucky for them, the University did not pursue them for royalties of the work.

Universities have got smarter, and now require most research workers to sign non-disclosure agreements and intellectual rights assignments as a condition of funding. Private entities, such as the Howard Hughes Institute, IBM, INTEL, etc, have had such requirements from the start of their contracting Universities to do research work. The result is that fewer research workers can get away with a huge fortune these days, but they are often .wooed by private entities with big salaries and perquisites. After all, especially in the transition from Basic to Applied Research, thence to Product Development, no one knows how the things work better than those who did the original research. And, of course, those scientists suffer a cruel fate because most people have an unfortunate ability: Monkey See, Monkey Do. So their seducers dispense with expensive scientists as soon as possible. Worldly wise scientists know this and make provision. Fools become paupers.

The Federal government, for unknown reasons, has been delinquent in preventing the sort of raids on taxpayer investments formerly common at Universities. So, these new rules are welcome. Hopefully, they will spread throughout the research establishment.

Note: Do not misinterpret my remarks. I am a very strong supporter of scientific research. But, I also believe the taxpayer is entitled to return on investment. Those research workers who've made fortunes by walking off with secrets are, in my opinion, embezzlers. I don't think scientists should have to live as monks, but I also think there is an old tradition of idealism - "do gooding" - in science. That tradition should be enforced.

I noticed the most recent example of greed and overreach just a few days ago, when it was reported in the SF Chronicle that University researchers proposed the State of California grant them royalties on their work. Thus, the rewards of the $3 billion bond issue funding Stem Cell Research would go to private parties, leaving taxpayers to hold the bag. That's totally unacceptable behavior.

Somehow, I connect these science rip-offs with the continuing false reports submitted to scientific journals. In many cases, the phony work dupes peer reviewers and editors, thus reducing the journal's credibility. In the long run, all of that undermines science and scientific knowledge.

So, while I am against Vows of Poverty for scientists, there is no doubt in my mind that there needs to be an enforced Vow of Dispassionate Honesty.

From the New York Times ...

Health Agency Tightens Rules Governing Federal Scientists

By GARDINER HARRIS
Published: August 26, 2005

WASHINGTON, Aug. 25 - After accusations that some government scientists used their official positions for private gain, the National Institutes of Health announced rules on Thursday that ban its scientists from consulting for drug companies.

"Our research should be based on scientific evidence that is not influenced by any other factors," Dr. Elias A. Zerhouni, director of the health institutes, said at a news conference.

The rules are being issued after disclosures that scientists at the institutes leveraged their positions to land lucrative consulting contracts that seemed to conflict with their official duties or at least overlap with them. Those contracts caused some critics to worry that research by the agency could be tainted.

An investigation by the agency concluded that 44 of its 1,200 senior scientists appeared to have violated rules governing consulting and that 9 might have violated criminal laws.

The conflicts were first reported by The Los Angeles Times.

The regulations are not as draconian as those that an internal panel proposed in February. Under those proposals, which caused an uproar, not only was consulting banned, but 6,000 scientists would have also been forced to sell all shares they owned in pharmaceutical and biotechnology companies.

Any remunerative activity outside of work - even selling jewelry or singing - would have had to be disclosed and approved by ethics overseers. All 18,000 employees would have been forced to limit their holdings in any one company to shares valued at no more than $15,000.

Under the final rules, the top 200 executives will be required to keep the value of their holdings in any single drug company below $15,000. Some 6,000 other employees will have to submit for review their holdings in such companies. If the holdings are determined to conflict with official responsibilities, the employees will be asked to sell these shares, officials said.

Agency scientists will also be allowed to hold fiduciary positions in medical societies as part of their lives outside the agency, a practice that the proposed rules would have banned.

"Clearly, we do not want to impede the normal academic interactions that scientists need to have with the rest of the world," Dr. Zerhouni said.

The changes were welcomed by scientists at the agency who had fiercely criticized the old proposals.

"This is a very good step forward, but it doesn't end the issue," said Dr. Ezekial Emanuel, chairman of the executive committee of the Assembly of Scientists, a group that filed a suit against the old rules and then withdrew it.

His group, Dr. Emanuel said, would continue to fight travel bans and bureaucratic inertia that he said is hurting the agency.

The changes disappointed some critics of the pharmaceutical industry's influence on research.

"These rules by no means end the influence of the pharmaceutical industry on N.I.H. employees," said Dr. Sidney M. Wolfe, director of the health research group at Public Citizen, the consumer advocacy group.

Dr. Wolfe noted that the new rules let employees deliver medical education lectures paid for by drug companies. Although no strings are supposed to be attached to the financing, Dr. Wolfe noted that scientists who disagreed with the positions of the drug industry were rarely invited to give such lectures.

The controversy surrounding consulting work and scientists' relationships with drug companies has been a black eye for the health institutes, which has for years enjoyed highly favorable press coverage and widespread support on Capitol Hill.

Investigations found that the health institutes had such poor and inconsistent controls over scientists' outside activities that the agency could not even answer investigators' basic questions about the extent of the problem.

One scientist, Dr. P. Trey Sunderland, a senior researcher at the National Institute of Mental Health, received more than $500,000 in consulting fees from Pfizer at the time he was collaborating with the company in his official work of studying patients with Alzheimer's disease.

Despite rules that require government scientists to notify the institutes of their consulting deals, Dr. Sunderland did not make such a report.

Dr. Zerhouni initially dismissed the problems as paperwork issues or the indiscretions of a few people. But as the disclosures built, he proposed modest changes.

Late last year, he proposed a one-year ban on all consulting work while the agency improved controls. Dr. Zerhouni termed the new rules "the most restrictive of any we know about in the world of biomedical research."

The revisions were made after officials received more than 1,300 comments, many fiercely critical, on the proposal. Dr. Zerhouni said he was not surprised that so many employees opposed the proposed rules. He said it was always his intent to adapt the new rules after receiving comments from outside.

The rules go into effect on Tuesday. Officials will have to divest their stock portfolios by Jan. 30. Dr. Zerhouni said he intended to re-examine the new rules in a year to make sure they have not had negative effects on the agency's ability to recruit top scientists.

Dr. Zerhouni also said he hoped to spur a broader discussion about conflicts of interest in universities.

Introduction
NIH announced new rules for its scientists, aimed at reducing conflicts of interest in NIH research. According to the NY Times, "An investigation by the agency concluded that 44 of its 1,200 senior scientists appeared to have violated rules governing consulting and that 9 might have violated criminal laws." This is a long overdue crack-down on unethical and quasi-ethical practices in government sponsored research. Even though most scientists start out "honest," that character trait seems to diminsh with success ...

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