Scientific, fact-based evidence -vs- financially-supported political agendas Part 5

Are CRE and RPC merely part of the ‘old boys’ network’?

My goodness, I hope not! But just for safety’s sake, and since our emphasis is on scientific, fact-based evidence, let’s just make absolutely sure, shall we?

So, the Center for Regulatory Effectiveness. What’s that then?

There is a somewhat troubling indication on the CRE website that US home-grown tobacco stock trading up or down is significant to the CRE! Hmm… time to investigate, methinks.

Jim Tozzi, the architect of the CRE, and indeed of the Data Quality Act – both of which have been criticised for attempting to robustly defend industry from regulatory attack – does indeed have some conflicts of interest which ought to be made known.

In 1972, he began working at the US Office of Management and Budget while Reagan was in power. According to SourceWatch:

Under his directorship, the OMB’s Office of Information and Regulatory Affairs was the gatekeeper for virtually all proposed regulations dealing with public health and safety.

Tozzi was at the OMB when evidence arose in the 1980s that giving aspirin to children with flu symptoms increased the risk of Reye’s syndrome, a potentially fatal complication. A federal health agency recommended that aspirin containers bear warnings, but Tozzi said he was not satisfied the evidence was good enough. It took years for activists and Congress to force the labeling issue — years in which almost 200 children died of Reye’s. Today, with labeling, the syndrome is extremely rare.

It occurs to me that there are a number of potentially nasty side-effects with paracetamol-based medications, too, which have been used as an alternative for children since aspirin was deemed ‘too risky’. With medication comes risk, but surely a proper analysis of the evidence is necessary?

In any case, if we want to take SourceWatch as a source of information, we need to understand its inherent bias, which is to expose people who are funded by industry. Either we are going to investigate through layers and layers of possible conflict, or we are going to look for the common sense and follow that.

In 1986, Dr Tozzi founded Federal Focus, a Philip Morris-funded non-profit organisation. He went on to become a significant lobbyist for Phillip Morris, and fought hard to prevent the FDA from gaining regulatory power over tobacco products. He is still involved with political efforts to push for the legalisation of marijuana.

Dr Tozzi (who holds a doctorate in Economics and Business Administration, not in medicine or other science) has some history of helping businesses achieve proportionate regulation, based on sound and secure scientific evidence, rather than opposition-funded potentially questionable science. This may be a good thing or a bad, depending on one’s viewpoint on any given issue. The real problem is that one can scientifically ‘prove’ just about anything – given sufficient funding from whatever quarter. Anyone who is insisting on checks and balances, rather than bald acceptance of so-called ‘scientific fact’, seems to me to be on the right lines – generally speaking.

In 2004, the Data Quality Act was criticised by the Washington Post:

Things were not looking good a few years ago for the makers of atrazine, America’s second-leading weedkiller. The company was seeking approval from the Environmental Protection Agency to keep the highly profitable product on the market. But scientists were finding it was disrupting hormones in wildlife — in some cases turning frogs into bizarre creatures bearing both male and female sex organs.

Last October, concerns about the herbicide led the European Union to ban atrazine, starting in 2005. Yet that same month, after 10 years of contentious scientific review, the EPA decided to permit ongoing use in the United States with no new restrictions.

Herbicide approvals are complicated, and there is no one reason that atrazine passed regulatory muster in this country. But close observers give significant credit to a single sentence that was added to the EPA’s final scientific assessment last year.

Hormone disruption, it read, cannot be considered a “legitimate regulatory endpoint at this time” — that is, it is not an acceptable reason to restrict a chemical’s use — because the government had not settled on an officially accepted test for measuring such disruption.

Those words, which effectively rendered moot hundreds of pages of scientific evidence, were adopted by the EPA as a result of a petition filed by a Washington consultant working with atrazine’s primary manufacturer, Syngenta Crop Protection. The petition was filed under the Data Quality Act, a little-known piece of legislation that, under President Bush’s Office of Management and Budget, has become a potent tool for companies seeking to beat back regulation.

The Data Quality Act — written by an industry lobbyist and slipped into a giant appropriations bill in 2000 without congressional discussion or debate — is just two sentences directing the OMB to ensure that all information disseminated by the federal government is reliable. But the Bush administration’s interpretation of those two sentences could tip the balance in regulatory disputes that weigh the interests of consumers and businesses.

John D. Graham, administrator of the OMB Office of Information and Regulatory Affairs (OIRA), who has directed implementation of the Data Quality Act, said the law will keep the federal government hewing to “sound science.” He said the act, which allows people and companies to challenge government information they believe is inaccurate, is equally accessible to “a wide diversity of interests, both in the business community and in the consumer, environmental and conservation communities.”

But many consumers, conservationists and worker advocates say the act is inherently biased in favor of industry. By demanding that government use only data that have achieved a rare level of certainty, these critics maintain, the act dismisses scientific information that in the past would have triggered tighter regulation.

Judge for yourselves, my friends, whether the Data Quality Act is a good thing or a bad, but bear in mind that it will also be applied to the consideration of electronic cigarettes and eliquid….

Jim Tozzi will be handing over to a successor at the CRE in the coming year, I understand.

And what of the Regulatory Policy Committee in the UK? Its website describes it as ‘Providing independent advice to Government on the quality of analysis supporting new regulations.’ This sounds good, providing it is accurate.

In ‘About the committee‘ it says:

The Committee consists of a mix of independent experts with a wide range of experience and current knowledge of business, employee and consumer issues. The Committee is supported by a secretariat of civil servants.

Michael Gibbons was appointed the first Chair of the Regulatory Policy Committee with effect from October 2009. Michael has a strong interest and background in better regulation both at domestic and EU level.

Working with Michael are the five members of the Regulatory Policy Committee:

• Dr David Parker – Emeritus Economics Professor of Cranfield School of Management;
• Dr Ian Peters – Chief Executive of the Institute of Internal Auditors;
• Philip Cullum – Deputy Chief Executive of Consumer Focus;
• Mark Boleat – Consultant on regulation and public policy;
• Sarah Veale – Head of the Equality and Employment Rights Department at the TUC

Owing to the wide range of backgrounds and ‘special interests’ covered in this list, this seems to me to represent a reasonably independent group, who could reach reasonably independent conclusions, irrespective of whether some or all of them held shares in a particular high-profile pharmaceutical company, for example, or had worked for the tobacco industry in the past. I have not looked for such conflicts, so do not know whether or not they exist. My point is that it is not necessary to do so, since the overall ‘blend’ is clearly a suitable vehicle for producing independent opinions.

Is it possible to avoid conflicts of interest completely? Not really. Is it necessary, for everyone connected with regulatory policy-making to be entirely unconflicted? No.

What matters is that there are sufficient checks and balances in place to ensure that no one group’s or individual’s personal agenda can skew a particular outcome. This, unfortunately, is what is entirely lacking at the MHRA. The two most significant conflicts of interest which mean that the MHRA is in no sense a suitable agency to regulate electronic cigarettes are these: their funding is largely drawn from the pharmaceutical industry whom they are tasked with regulating (and who are in direct market competition with the electronic cigarette industry); and there are too many pharma shareholders in the MHRA’s ranks who have a vested interest in helping them market their products, even if those products are unsafe, and ineffective.

Conflicts of interest are inevitable. After all, everyone has to make a living. However, it does seem that some are more acceptable than others.

Even I have conflicts of interest, although I have declared these whenever opportunities to do so have arisen. For the record, I shall do so again now.

I am a paid consultant for ECITA Ltd; I am also a shareholder in that company; my brother, Peter Cole, owns and operates the only (current) UK business manufacturing eliquid to USP/EP grade standard, Decadent Vapours; I operated a small retail business, FreeGenie Ecigs, for a short time, but this is now closed; and I lost my husband to cancer when we were both aged 31.

I have an agenda, folks. Sorry if that is a disappointment. I would just like to clarify what my agenda is, though, for anyone who doesn’t know:

I have made it my mission to assist the Electronic Cigarette Industry in getting the truth about smokers’ options out there in the public view;

to achieve credibility for this industry in the global market-place;

to ensure that my colleagues in this industry are operating legally, and to the Industry Standard of Excellence ECITA is leading;

to assist regulators in formulating appropriate, proportionate and sensible regulatory frameworks for these innovative products;

to do everything in my power to make sure that no more children have to watch their parents waste away and die before their very eyes from smoking-induced cancer, as mine did.

If smokers can be told the whole truth about their options, they can make genuinely informed decisions. For some, that may be to continue to smoke; for some, it may be to choose a medicalised quitting method; and for some, it may be to choose an alternative means of taking nicotine which has massively-reduced risks, such as smokeless tobacco, and/or electronic cigarettes.

The ‘quit-or-die’ lie has to be tempered with the truth.

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