SCI/TECH: New Ethics Rules Cost NIH Another Top Researcher

New ethics rules recently passed at the National Institute of Health are too constrictive for many of their top researchers. The new rules state that an NIH employee cannot stand on an executive position with a private company, paid or unpaid. It also states that no NIH employee can recieve awards, payments or gifts of more than $200 from private firms. In addition to this, the new ethics rules state that employees must report any external source of income to NIH, and requires approval from NIH to continue. This includes ownership or interest in small businesses, stocks held, executive positions with other firms, among others. This new set of rules has cost NIH several top researchers, and has had an impact on the local biotech industry, which is the primary industry in Montgomery County, Maryland, where NIH is based.



This new policy seems inherently invasive, and quite possibly harmful to the thriving biotechnology industry in the Washington, DC area. Many of the smaller biotechnology firms in the DC area rely on having top NIH researchers on their executive board (often times in an unpaid position) in order to gain credibility for their own research.

In addition to this, researchers are also highly limited in the amount of royalties they are allowed to accept from pharmecudical companies that market medicines based on their research. Often, this is why researchers stay with NIH, as their primary salary from NIH is often much less than they would be able to make elsewhere. Junior researchers typically start around $40,000/year with NIH, whereas they could make as much as $60,000/year to start elsewhere. However, the benefits of working for a prestigious agency alongside top researchers in the field are a great asset. Many employees feel that if these top researchers are leaving, then there's no point in staying with NIH.

Related News Links:
www.nih.gov
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'bout time. Credibility? Where was the credibility when firms employed or honored the very people that were supposed to be the publics watchdogs? These officials already violated federal law and should be punished for their past and present violations.

Too cozy of a relationship to ask for credibility.

Good find obsidian468,

I think we do need to balance the ethics of a governing body with the understaning that we do not always get the best and the brightest to the government sector.

Fred, most definitely. I find this story also important on a personal level, since my girlfriend is an employee of NIH (researcher and trainer), and this affects her. I've heard her grumble about "BS at work" a few times lately, but she hasn't been willing to elaborate for the sake of her sanity. Now I think I know why she's been upset. This could potentially harm her other business venture (completely unrelated to the biotech field), which she uses to pay bills and such.

Originally posted by Terapin
I think the new regulations are a step in the right direction. Being paid by a pharmaceutical company while one of its drugs is under the scrutiny of NIH is a clear conflict of interest. The same goes for holding stocks in other bio/pharm businesses. If there is any disruption in business in the area it will be short lived. No privately owned company NEEDS a NIH employee on its payroll. Honest IS the best policy and this just makes things much clearer.

I am astounded that things went as far as they did, and that some people think 'conflicts of interest' might be normal business. Not in government!

Unfortunately, the integrity of NIH researchers has been called into question because of prior abuses of an extremely lax system. The NIH is supposed to be an entity that exists to support the public, however its decisionmaking seems to be clouded by personal relationships that its' researchers have with corporations--and in some cases, these decisions led to life being put it jeopardy.

The LA Times published an article in December 2003 which reported on the problems at the NIH. Some of questionable behavior that the LA Times found included:

Interviews and corporate and federal records obtained by the Los Angeles Times document hundreds of consulting payments to ranking NIH officials, including:

* Katz, director of the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases, who collected between $476,369 and $616,365 in company fees in the last decade, according to his yearly income-disclosure reports. Some of his fees were reported in ranges without citing exact figures. Schering AG paid Katz at least $170,000. Another company paidhim more than $140,000 in consulting fees. It won $1.7 million in grants from his institute before going bankrupt last year.

* Dr. John I. Gallin, director of the NIH's Clinical Center, the nation's largest site of medical experiments on humans, who has received between $145,000 and $322,000 in fees and stock proceeds for his consulting from 1997 through last year. In one case, Gallin co-wrote an article highlighting a company's gene-transfer technology, while hiring on as a consultant to a subsidiary of that company.

* Dr. Richard C. Eastman, the NIH's top diabetes researcher in 1997, who wrote to the Food and Drug Administration that year defending a product without disclosing in his letter that he was a paid consultant to the manufacturer. Eastman's letter said the risk of liver failure from the drug was "very minimal." Six months later, a patient, Audrey LaRue Jones, who was taking the drug in an NIH study that Eastman oversaw, suffered sudden liver failure and died. Liver experts found that the drug probably caused the liver failure.

* Dr. Ronald N. Germain, deputy director of a major laboratory at the National Institute of Allergy and Infectious Diseases, who has collected more than $1.4 million in company consulting fees in the last 11 years, plus stock options. One of the companies collaborated with his laboratory on research. The founder of another of the companies worked with Germain on a separate NIH-sponsored project.

* Jeffrey Schlom, director of the National Cancer Institute's Laboratory of Tumor Immunology and Biology, who has taken $331,500 in company fees over 10 years. Schlom helped lead NIH-funded studies exploring wider use for a cancer drug -- at the same time that his highest-paying client was seeking to make the drug through genetic engineering.

* Jeffrey M. Trent, who became scientific director of the National Human Genome Research Institute in 1993 and, over the next three years, reported between $50,608 and $163,000 in industry consulting fees. Trent, who accepted nearly half of that income from a company active in genetic research, was not required to file public financial-disclosure statements as of 1997. He left the government last year.

It is impossible not to give the appearance of impropriety when NIH researchers are sitting on pharmaceutical boards or consulting--and then involved in related NIH projects (paid or unpaid). They are supposed to recuse themselves--but some didn't. In order to instill confidence in the health system, there can't even be an appearance of collaboration between NIH researchers and corporate America.

But instead of making researchers adhere to strict codes of ethics regarding conflicts of interest, there basically were none. The NIH has been operating under an honor system that gave it's researchers free reign to work on outside projects without much oversight to ensure that disclosure rules were being followed. Researchers could hide external sources of consulting income from public disclosure--and 94% of all of the highest paid researchers did just that.

I think that because of the mistakes made by the NIH and the credibility issue that they currently face, they need to instill a strict policy. Perhaps at some point when NIH integrity has been restored, perhaps consulting rules can then beging to loosen up somewhat to attract more talent--but until then, working to become once again an advocate for the public instead of corporate America is their main concern.

The entire LA Times article can be found here...
www.anderson.ucla.edu...

obsidian too bad about your girlfriend.

Ethics in government are always subject to abuse. People that work for the government should realize the 'public trust' aspect is as important as the balance of their job.

Fred, you're out of line. That is inflammatory bunk you posted. Pure bunk-speculation you can't back up.

I've known a fair amount of people that worked for the government and they are not much different from industry people. Good and bad.

It's really a toss up regulate things too little, and you end up with a nightmare. At the same point if you make the restrictions too tight you could end up with nothing but career bureaucrats who barelly managed to make it through school.

Depends on what 'regulators' are supposed to do. This is a big problem with some agencies. They have no focus on their job. Are these agencies research centers or oversight offices?

Research centers abound. Oversight is what is lacking. No one needs to be a P.hD. In nuclear physics to oversee Los Alamos. What is needed is an investigator used to dealing in white collar crime.

Inspector Generals (I.G.) are supposed to do this but all to often don't. The I.G., no matter what they say publicly, all to often skirts around 'management.' As in lmgnyc's site, look at the top people getting rich from tax payer dollars. How many better contracts could have been awarded if done fairly?

These people should do some jail time. No plea out and fine- JAIL

Don't defend these people. They are crooks. They use their positions and inside contacts to rob each and everyone one of us.
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Originally posted by FredT
Good find obsidian468,

I think we do need to balance the ethics of a governing body with the understaning that we do not always get the best and the brightest to the government sector.

Hi Fred! This is Obsidian's girlfriend. Obsidian said I could post something about this article and is currently sitting here with me. I am currently waiting for approval and you will catch me on here as deadynightshade in the future- just fyi. I work for NIH as the "red headed stepchild" as a contractor there. I assure you that not everyone with a PhD is the brightest bulb in the box, but I can also attest to the fact that the government sector certainly hires some total peons, many of which I am suppose to train. I leave there on a regular basis going, "We are the saviors of humanity against diseases?" and shake my head in disgust.