GEP (SGDoc 1998)

This article is part of the Tobacco portal on Sourcewatch funded from 2006 - 2009 by the American Legacy Foundation.

Smoking Gun Document -- Good Epidemiological Practices

This was a long-running attempt to create a scientific standard for epidemiology which made it particularly difficult for environmental and health scientists to conduct studies that were accepted by legislators as demonstrating harm -- a standard that would hamper the regulatory agencies in their labelling of harmful substances.

The Good Epidemiological Practices project had been created by Philip Morris disinformation executive/lawyer David Bushong and outside consultant George L Carlo -- who went on to even greater fame as the Director of the cellphone industry's Wireless Technology Research (WTR) program. He managed to spend $25 million on radio-radiation research "without getting a test-tube wet". This was a cellphone industry scam to exonerate the early (and possibly harmful) Time Division Multiple Access (TDMA) cellular phone technology from charges that it had not been adequately tested before being sold to the public. This was a high-powered strobe-pulse-type transmission (held against the side of the head) which had been released in the USA and Europe without biological testing. There were two short-lived TDMA standards known as GSM (most of the world) and D-AMPS (USA only).

After having spent the $25 million and wanting more to continue the WTR project, Carlo became embroiled in a fight with the Cellphone Telephone Industry Association (CTIA) over money). He then resigned and set up the BioPro operation flogging spurious 'cellphone radiation protection' shields to stop people getting brain cancer from the devices he had just 'proved' to be safe. But, by then, the cellphone industry had dropped the dangerous pulsed-power GSM and D-AMPS technologies and had switched to the standard used today -- a low distributed-power standard known as W-CDMA (Wideband - Code Division Multiple Access).

Carlo had many companies and 'research institutes' and he provide so-called 'research services' to many industries. He began working for Dow Chemicals conducting research to exonerate dioxins against the charge that they produced birth defects and had other health consequences. Dioxins are extremely toxic and mutagenic compounds that contaminate agricultural chemicals and are generally created during the manufacture of herbicides and pesticides. They were responsible for the Agent Orange scandal following the Vietnam War. Carlo's staff also worked on proving that Breast Implants were safe when biological concerns were raised about the lack of biomedical testing of these implanted devices. In fact, there was little that George Carlo and his team couldn't prove to be perfectly safe … provided they were paid enough money by the company or industry concerned.

This is a split entry.
The normal GEP entry.
The Index of GEP documents
This Smoking Gun Document

The GEP scam is also generally considered to be an offshoot of the TASSC sound-science/junk-science scam also run by Philip Morris. This was the creation of a pseudo-scientific association known as The Advancement of Sound Science Coalition run in the USA by lobbyist Steven Milloy and created, controlled and funded via Philip Morris's own-controlled PR firm APCO. There was also a closely-related, London-based European Science and Environment Forum (aka "Euro-TASSC") run by Roger Bate through the Libertarian think-tank, the Institute of Economic Affairs (IEA) which provide PM Margaret Thatcher with her anti-union/anti-welfare economic ideology. Both of these organisations were devoted to generating claims that certain scientific studies were "junk science". Milloy became a favoured commentator on Murdoch's Fox News network in the USA.

Documents & Timeline

1994-1995 Kelly G Sund who was George Carlo's general factorum at Health & Environmental Services Group (HESG) lists herself in her personal biography as occupying two positions simultaneously. She is:

• Associate Director of Research at the HESG [Health & Environmental Sciences Group]. Carlo used Health & Environmental Sciences [HES] and HESG as his primary organisations
• Director of the GLP-Laboratory (note 'good LABORATORY practice'). No further details are given. She maintains that she was simply a director until 1995 -- then "Director of Research GLP-Laboratories" (deliberately hyphenated) until 1997.

Carlo, Sund and James Baller (George Carlo's lawyer) flew to Australia and gave the green light to Nufarm (Dow subsidiary), the manufacturer of the herbicide RoundUp, following an accidental spill of dioxin-laden chemicals into Melbourne's water catchment areas.

1994 Mar 10 Matt Winokur at the head office of Philip Morris Corporate Affairs in New York has requested an opinion from the scientific staff about the GEP Project from Tom Borelli (Science & Technology in USA) and from Helmut Reif the Director of Science & Technology (S&T) in Switzerland, and his staff scientist Ruth Dempsey and Mitchell Ritter at the Scientific Affairs division in Neuchatel. He has asked for their input:

GEP Review I need the evaluation of the CMA's GEP criteria, and any further comments SA/S&T may have, prior to our next IARC task force meeting on March 29. Will you be able to have the consultant's evaluation by then?

[CMA = Chemical Manufacturer's Association which had previously established their own GEP project (with Carlo).]

[SA/S&T = Philip Morris's Scientific Affairs and Science & Technology divisions which preceded the WSA in USA and Switzerland.]

[IARC task-force = a collaborative group from all the tobacco companies meeting to coordinate their attacks on the science used to condemn cigarettes by the International Agency for Research into Cancer.]

---

1994 Mar 15 Tom Borelli of Science & Technology (S&T) in the USA has drafted his opinion and circulated this to the Swiss executive scientists working on the GEP scam (presumably before sending it to Winokur).

GEP Review Dear Ruth & Mitch, I reviewed the criteria It's not a bad place to start by [but] it lacks teeth and, as written, it does not have enough meat to help us on ETS [Environmental Tobacco Smoke = The passive smoking problem] However setting up our own standards is a good project for us and our consultants's program. It would be good offensive strategy for our consultant's to be out there trying to fix epidemiology instead of being critical all the time. I will send you a copy of the Carlo survey on epidemiology standards as a possible starting point.

George L Carlo was the outside contract disinformation contractor who had suggested the idea to Philip Morris (Borelli was his handler). He had borrowed the GEP idea from his Dow Chemical client and the umbrella Chemical Manufacturer's Association (CMA). The idea was to modify it to better suit the requirements of the tobacco industry.

Helmut Reif, then the Director of Philip Morris's European Union (EU) and East Europe/Middle East/Africa (EEMA) division in Switzerland has checked out the progress of the GEP and substantially agrees with Tom Borelli.

Ruth is Ruth Dempsey and Mitch is Mitchell Ritter, two of the Principle Scientists under himself and Ted Sanders.

GEP Review Dear Ruth & Mitch Just in case you did not receive. I think that this [the Borelli opinion] covers our opinion as well. The GEP is not bad, but too soft. However, it goes into the right direction and could serve as a piece of "constructive critique" of the existing approaches for our consultants. Helmut.

He appears to be less than enthusiastic about the GEP project, but suggests that the existence of the pseudo-standard might allow their helpers (consulting scientists) mount some form of credible objection to any adverse scientific health study which might later turn up.

The discussion about the wisdom of trying to get their version of the Good Epidemiological Practices document accepted as a scientific standard (without revealing their hand) then went on for another three years.

The Corporate Affairs division of Philip Morris (under Andrew Whist and Matt Winokur, together with Tom Borelli from S&T) recruited a number of prominent scientists (some not knowing the source of GEP) and they held two preliminary international scientific conferences trying to formulate and have accepted a GEP standard suited to their purpose. The ploy was to have it discussed and passed by a conference of experts -- then published as a scientific standard.

---

1994 Oct The Landsdown Conference was held in the Landsowne Conference Center the USA in October 1994 with 19 participants. It was organised (and had considerable input from) by George Carlo's associates, Thorne Auchter and James Tozzi via their jazz-think-tank Federal Focus [1] This was a trial run with a mixed group of both well-paid tobacco helpers and a couple of probably-honest scientists who were needed to lend their prestige to the undertaking. Some also came from the chemical industry.

The papers from conference were later published as 'The Role of Epidemiology in Regulatory Risk Assessment edited by Harvard's dubious for-sale scientist/administrator John D Graham. (Elsevier Science B.V. 1995).

---

1995-1997 Kelly Sund lists her work record as "Director of Research GLP-Laboratories" (deliberately hyphenated) from 1995 until 1997.

However she also lists herself as Science outreach coordinator for Wireless Technology Research, Washington during the period1994-1995 This was Carlo's $28.5 million propaganda operation, which involved no actual research, for the Cellular Telephone Industry Association (CTIA)

---

1995 Sep-Oct The London Principles Conference was run by tobacco lawyers Covington & Burling in 1995. It had a closely controlled invitation list to ensure that the tobacco industry had the numbers to block unwanted changes, and force through their own wording. [2]. It resulted in a publication: Principles for Evaluating Epidemiological Data in Regulatory Risk Assessment: which it claimed had been developed by an expert panel at a conference in London, England October 1995. [Again the Auchter-Tozzi Federal Focus Inc. was credited with organisation and the publication.]

They were also disturbed to find that an "independent GEP-theme conference [was to be held] in Luxembourg in October 1995" It was being organised by the IARC/World Health Organisation's DG V (division responsible for cancer research) to look at problems of contamination in the metal industry (fumes from smelters, etc) [3] Winokur decided to fund either Dr Rory B Conolly (from the Chemical Industry Institute of Toxicology - CIIT) or Maurice LaVois (then at San Francisco Uni -- but a partner in many scams with George Carlo) [4] to attend this conference and present a paper.

He ended up sending the notorious anti-science lobbyist and "junk man" Steven Milloy (who ran The Advancement of Sound Science Coalition - TASSC) for the tobacco industry which labelled any adverse scientific findings as 'junk'. Milloy was controlled by Philip Morris's own PR company APCO. Rather than present a paper, he was contracting Milloy to create popular humourous criticism about those involved at Luxembourg. [5] His report (prepared by lawyers Shook Hardy & Bacon) has been culled so only the cover-sheet remains. [6]

See GEP (Doc Index) for more detailed information about all these events.

The Main Document

1998 Apr 3 Ted Sanders (the Principle Scientist under Helmut Reif in Switzerland) is now responsible for the GEP (Good Epidemiology Practices) project created three years earlier by science consultant George L Carlo and PM executive David Bushong. In this memo to his superior Cathy Ellis at Worldwide Scientific Affairs in New York, he provides a good overview of the motivations behind the project, and some details of its history. This GEP project had been expanded to include chemical companies like Dow Chemical, and other industries with poisoning and polluting problems. [7]

1998 April 3 Cathy, Now for the short course on GEP's. Approximately three years ago, the concept of GEP's was discussed in considerable detail in PM. Corporate Affairs thought it was a wonderful idea, because at first they (and in particular one David Bushong who is now at the Washington office and no longer involved in GEP's) felt that part of a code for Good Epidemiological Practices would state that any relative risk of less than 2 would be ignored. This is of course not the case. No epidemiological organization would agree to this and even Corporate Affairs realizes this now. Corporate Affairs at PM was run by Stephen Parrish, Andrew Whist and David Bushong). {Note: A relative risk of 2 would require a study which showed a doubling of lung-cancer or heart disease before the study-authors were able to claim "significant" increase in disease. When other factors are taken into consideration -- like air pollution, and passive smoking by non-smokers -- it would be almost impossible to design and finance a study which would find such a level of extra risk among smokers. Therefore it would be almost impossible for legislators to take action on health grounds, based on such epidemiological study findings. By setting the bar so high, no company with a pollution or poisoning problem would ever need to face independent studies showing adverse health effects which could be claimed to be showing a "significant" or "substantial increase".] A number of initiatives were attempted, but the one initiative which continues in Europe is currently under the auspices of John Rupp. John Rupp was the chief industry corruption lawyer who worked through Covington & Burling in Washington, and for a while out of London. He did most of the recruitment of corrupt scientists in association with Myron Weinberg who ran the specialised scientific recruitment firm of The Weinberg Group (TWG) (aka WashTech). Rupp had an almost unlimited budget and was virtually free to develop projects under his own initiative. Now Mr Rupp, as you may know, has one outstanding good quality and one major fault. His good quality is that he is intelligent, effective, and gets things done. His fault is that he is intelligent, effective, and gets things done. John, with the help of our old friend Myron Weinberg, put together a consortium of companies in France who were interested in the idea of GEPs. [The GEP idea had originally come from the chemical industry. Rupp and Weinberg were perhaps also running a side business by getting these other industries involved (for a fee) which would have also served the interests of the tobacco industry, since the other industries would have served to provide cover for tobacco.] This consortium, headed by an epidemiologist at Dow Chemical France, put together an excellent code of Good Epidemiological Practices. {He probably means Carlo with Dow Chemical in the USA] The first public presentation of this code will be on April 23 in Graz at an epidemiology meeting which I will be attending. John has also been carrying out considerable lobbying (by himself or through others, I don't know) an organisation called ADELF which stands for (after translation and rearrangement) the Organization of French Speaking Epidemiologists. It has been John's goal to assure acceptance of the consortium code by ADELF. John has also initated similar activities in Italy and Germany. Total expenses for this program in 1997 were about $300,000. This includes approximately $200,000 for John and some other consultants (minor charges) and $100,000 for Myron Weinberg. John forsees similar expenses for himself for 1998 -- if the program continues as before (a big if) -- but there should be no further involvement by Myron. For quite some time I seem to have been the lone voice of dissent regarding the GEP project. I had two major concerns: The first is that I felt that the company was placing itself in a vulnerable position For me, however, the more important point is that I would much prefer to see a code of GEP's debated without it necessarily being accepted by any scientific organization. The reason for this is that in my humble opinion the "science" of epidemiology is not far enough advanced to have identified anywhere near all the potential sources of error in an epidemiological study. Therefore, if a code of GEP's becomes "cast in concrete," it will be even more difficult for anyone to argue (and this point goes far beyond the cigarette industry) that the results may not be meaningful. A very simple thought experiment outlines my point: If two laboratories, both using GLPs (Good Laboratory Practice standards) perform an analytical determination for arsenic in two different parts of the world, there is at least a 95% probability that the two answer will agree within the experimental error. If two laboratories perform an epidemiological study on the association of cellular phone usage with brain cancer using GEP's, there is well under a 50% probability that the two relative risks will agree with each other within the 95% confidence limit. Imagine my joy when I was told in November that, Corporate Affairs having lost complete interest in this project, that I would be inheriting it. I have had some preliminary conversations with John Rupp, which at least have served to slow things down [done] a bit, but some decisions still need to be made. [Corporate Affairs in New York under Steve Parrish and Andrew Whist was entirely devoted to lobbying, bribery, propaganda, and scientific corruption, so this was the source of their interest. However Whist was about to be deposed in the Oklahoma case (which exposed many of his underhand activities), so Corporate Affairs would have been clearing out its files and transferring its functions. Too much had already been revealed. They therefore probably did the standard corporate thing, of dumping the project on the far-off staff in Switzerland, where they couldn't easily object, and where it would be more difficult for lawyers to expose in any court case. After badgering Richard (Carchman) for a while, he suggested that I speak to the WRA lawyers, and I did have a long conversation with Roger Whidden, Mark Berlind, and Paola DeKock. They all agreed with my concerns, and were supposed to get back to me with a plan of action. I have been waiting for about three weeks now. [WRA = Worldwide Regulatory Affairs are the political lobbyists in Washington who would have had to convince politicians that GEP should be incorporated into future legislation as THE standard to be met before legislation would be enacted.] I think that we need to resolve this matter sooner or later. I would feel comfortable with PM acting as a member of a consortium looking into the development of a code of GEP's and identifying areas of research which need to be carried out in the field of epidemiology in order to better quantify sources of errors. Under such conditions, I would expect PM to support the program to the same extent that any other company in the consortium supported it. He is not opposed to the scam of creating a pseudo-scientific standard designed to limit regulation; what he really objects to is having PM lead the consortium and sticking its neck out I do not feel comfortable supporting the program as we are currently doing. I would agree that PM may not be an acceptable partner in such a consortium, and if that is the case, tant pis. ('tough luck") The problem is that other companies and industries might not wish to be associated, even in a consortium, with the notoriously corrupt company like Philip Morris.

Follow up

---

1998 Jul 22 Sanders is working with Cathy Ellis (Worldwide Scientific Affairs (WSA), at PM New York) on promoting the fake scientific standard called GEP (Good Epidemiology Practices. This was a very elaborate plot, initiated mainly by George L Carlo to design, promote and have legislated a standard for epidemiological research which was so high that it was virtually impossible for products like cigarettes to be implicated as causal in adverse health matters. It was a very clever manipulation technique which largely succeeded with some legislators, politicians, and semi-scientific organisations.

Cathy Ellis was the nominal at the head of PM's Worldwide Scientific Affairs, alongside Richard Carchman. Sanders is complaining that he continues to receive GEP bills many years after the project was supposedly abandoned. Since the purpose of GEP was to create misleading propaganda, these bills should have gone to Matt Winokur at the Corporate Affairs division, or to lawyer John Rupp (Covington & Burling) -- not to WSA which was supposed to deal in real science.

By mid-year 1998 Philip Morris had long decided to withdraw support for GEP (and also for the ASEAN conference assigned to Weinberg's consultancy group). Sanders wrote to Ellis:

Aside from the fact that I continue to receive GEP bills from all sorts of places for old work (the latest is from $weden, and none of them is parflcularly large), I recently received a bill from John (Rupp) himself for work done in the month of May . My understanding from conversations with Richard (Carchman), Matt Winokur, and Paola de Kock was that no further work was to be done on GEP's, and that John was in agreement with that decision. After I received the bill, I spoke to John Rupp himself. His impression was that Denise Keane had authorized him to continue the program, although only with respect to what he was doing in France. In other words, the program would not be expanded to other countries.[8]

[Note: The GEP project turned out to be a failure because they took a highly exaggerated position with lobbying in trying to make it into a recognised scientific standard for US and European parliaments when creating legislation over health concerns.]

Palao DeKock was a PM Worldwide Regulatory Affairs (WRA) lawyer in Washington DC]

Denise F Keane was the assistant/deputy to the new lawyer/head of Corporate Affairs, Steven Parrish.]