Friday, January 27, 2006

Ecstasy-Parkinson's Connection?

This report was written in 2002

Take note

WASHINGTON, Sept. 26, 2002


"A young individual who sustains injury to these dopamine cells and depletes their reserve may be at greater risk of Parkinsonism."
Dr. George A. Recaurte
Johns Hopkins University

Partying with Ecstasy several times a night, a common practice among users of the illegal drug, may damage key neurons in the brain and perhaps hasten the onset of Parkinson's disease, according to a study in monkeys.

But some researchers were skeptical that the results from the animal studies translate to humans and said such studies discourage research that might lead to medical uses for Ecstasy.

A Johns Hopkins University researcher injected squirrel monkeys and baboons with three shots of Ecstasy, also known as MDMA, three hours apart, mimicking dosages "often used by MDMA users at all-night dance parties." He said the drug caused enduring damage to dopamine-producing neurons in the brains of the animals. “The damage was still evident two weeks to six weeks later,“ said Dr. George A. Recaurte, the lead author of the study, which appeared in the journal Science. But he said it is not clear if the damaged neurons will repair themselves, a key factor in whether Ecstasy could cause Parkinson's disease.

Parkinson's disease is a brain disorder triggered by the permanent loss of dopamine-producing nerve cells. "We already know from the literature that brain dopamine declines with age," he said. "A young individual who sustains injury to these dopamine cells and depletes their reserve may be at greater risk of Parkinsonism."

But MFEMF A. Holland, a psychiatrist on the faculty of the New York University School of Medicine, said earlier studies on humans have failed to show that Ecstasy causes permanent damage to dopamine neurons. "It is a big leap to extrapolate what he is seeing in these primates and what you expect to see in Parkinson's syndrome," Holland, the author of a book on the risk and recreational use of Ecstasy. She said Ricaurte's research has helped "demonize" Ecstasy and prevented studies to determine if the drug could be used to treat post-traumatic syndrome.

Dr. Alan I. Leshner, former head of the National Institute on Drug Abuse, however, said the Ricaurte study shows "that even an occasional use of Ecstasy can lead to significant damage to brain systems."

Stephen Kish, a University of Toronto researcher studying Parkinson's disease and Ecstasy, said he analyzed the brain of a deceased habitual Ecstasy user two years ago and found no evidence of dopamine neuron damage. "Ricaurte's findings do raise a concern that Ecstasy may damage the dopamine neurons and potentially cause Parkinson's," said Kish. But he said the current study "might not translate to humans" and has not proven a clear connection between the drug and the brain disease.

In the study, the animals were given six milligrams for every 2.2 pounds of their weight. One of five monkeys and one of five baboons used in the study died shortly after receiving the shots. The brains of the surviving animals were examined microscopically and chemically after two to eight weeks. The nerve endings where the dopamine is processed were destroyed, said Ricaurte.

"There hasn't been a single animal that escaped the dopamine (cell) lesions," he said.

Ricaurte said the damage was not enough to cause Parkinson's symptoms, but there is "a clinical concern" that repeated use of Ecstasy will diminish the natural reserve of brain cells and lead to early disease.

Holland said Ricaurte's study in monkeys and baboons does not relate to the experience of human recreational users of Ecstasy. "The dose that he gave killed 20 percent of the animals immediately," said Holland. "Clearly these animals reacted to the drug differently than humans because not one out of five Ecstasy users drops dead."

Also, she said Ricaurte's study injected Ecstasy, while most human users take the drug orally. Drugs taken orally are less concentrated in the body than drugs that are injected, said Holland.

The NYU psychiatrist said "there is a lot of politics involved" in Ricaurte's study because the government does not want to allow medical research with Ecstasy, even though it has been approved for study by the Food and Drug Administration.

Ricaurte's research has been funded by the National Institute on Drug Abuse, the agency Leshner once headed. Leshner is now chief executive officer of the American Association for the Advancement of Science, the organization that publishes Science, the journal printing Ricaurte's current study on Ecstasy.

... does not relate to the experience of human recreational users of Ecstasy. "The dose that he gave killed 20 percent of the animals immediately," said Holland. "Clearly these animals reacted to the drug differently than humans because not one out of five Ecstasy users drops dead."

No, but they do die. The warning is there. Ignore it if you will, but tough if it all goes wrong. Playing with your life for recreational purposes.

Makes it sound like a hobby. What fun!

What actually is recreational drug use?

Tuesday, January 24, 2006

Cancer Patients Wrongly Cleared

Seventeen women had a diagnosis delay of more than three months. Twenty-two women with breast cancer were wrongly given the all-clear after misdiagnoses by a radiologist at two hospitals in Greater Manchester. The consultant radiologist, who worked at North Manchester General Hospital and Trafford General, has not been named but has since been suspended.

The radiologist worked at North Manchester and Trafford hospitals. It states that decisions for 238 patients were wrong, and of those, 22 women who were given the all-clear have now discovered they have breast cancer.

Of those 22, 17 had a delay in diagnosis of more than three months. Delays of more than three months for the diagnosis of breast cancer can have serious implications. One woman had a delay of two years before she was told she had breast cancer.

Dr Richard Campbell, medical director at Trafford, said: "None have died. It is possible we think in 17 cases, out of 22, the delay in diagnosis was long enough that it might alter their outcome. "The longer the delay, then of course, your risks are going to go up."


Health managers have admitted that some of the women could die because of mistakes made from April 2003. Almost 2,500 scans were checked again after concerns came to light last year. The mammograms carried out by the consultant were recalled and re-checked after concerns were raised over the quality of his work last year.

Chris Harrison, from Greater Manchester Strategic Health Authority (GMSHA), said: "On behalf of the health authority I offer my apologies to the women affected by this, and for the worry and distress caused, in particular to the patients whose cancer diagnosis became delayed as a result of this incident.

"We will be commissioning a full, independent investigation into the circumstances of this incident to identify the route causes, what underlies this, what can we learn from it and how can we prevent it from happening again."

Small comfort for those affected. Possibly seriously because of an anonymous consultant's (alleged) incompetence. It's just not acceptable.

Corruption trial opens in France

Ex-minister Drut was convicted in a case from Chirac's time as mayor. Forty-nine businessmen and public housing officials have gone on trial, accused of taking bribes when President Jacques Chirac was mayor of Paris. Prosecutors claim that during the 1980s and 1990s, housing department officials received bribes from contractors for licences to build council housing.

They say (allegedly) that the money was used to fund Mr Chirac's Rally for the Republic (RPR).

Mr Chirac has denied any wrongdoing and is protected by presidential immunity from standing trial.


Monday, January 23, 2006

Energy source?

Perhaps there is something in the claim that the West is attempting to keep the Middle East technology-poor. And this smells of desperation. A realisation that current methods of supplying power for all needs is not sustainable. Resources are running out as demand is ever increasing. Nuclear energy is not the way forward. It is dangerous and very unclean. Toxic waste is a reality.

Planet Earth has been geared up to rely totally on a resource that will expire - and not too long into the future. The Mad Max scenario is a very real one. The resource will run out and in the process the Earth's atmosphere will be destroyed. Life will end. The Earth will recover in a few millions of years without the help of the Human destroyer/polluter. The picture is becoming clearer by the day.

Alternatives have to include solar, wind and water power. The Moon will continue to go around the Earth for billions of years so tides will be there essentially always. It costs nothing to operate the Moon! Make it go round the Earth maintaining tidal movement. Piles of money are to be made from this. At little cost. Running costs are basically zero. And people are used to paying for power.

Conventional money making schemes are finished. The old guard will disappear. New ideas will flourish. The Earth will flourish. The New Age. No fossil fuel burning, no toxic nuclear waste. No global warming (and it's a reality). Life will go on.

Those misguided individuals who imagine money can buy longevity (cryonic storage) could at best come back to a World so different they would be driven into madness. The liquid nitrogen necessary would not be replaced when it had run out.

The government is asking industry and the public for ideas - it is time to decide to "close... or open the door" to nuclear power, Trade Secretary Alan Johnson has said. The 2003 Energy White Paper "had rightly" focused on boosting renewable energy and energy efficiency, but left the door "ajar" on nuclear. But, as a public consultation into UK future energy needs begins, he said it was time to take a decision on nuclear.

Critics say nuclear power is too expensive, is a terror threat and creates much radioactive waste.

True, true, true.

Do you see what's happening here? Being manipulated into a limited choice that only includes what is wanted?

Be careful. Stay awake.

Mr Johnson spoke out as it emerged that ministers had asked the Health and Safety Executive to look at the safety, cost and suitability of existing nuclear plants. Environmental campaigners fear the HSE study is a prelude to an expansion of Britain's nuclear network.

Friends of the Earth suggest: "We can tackle climate change and meet our energy needs by cutting waste, harnessing the power of renewables and using fossil fuels more efficiently". They believe the HSE review, set to take 18 months, has been requested to save time if the government does give the go-ahead for new power stations.

Mr Johnson says he still has an open mind (really?), but adds that it is "crucial" to consider how Britain will meet its energy needs in the next 50 or 60 years. True.

50 or 60 years? 5 or 6 more likely.

He said the HSE would also look into the viability of other ways of generating power, such as wind turbines, gas transport and storage and carbon capture and storage. And as he launched a three-month public consultation on the issue, he said:

"We need to look at the risks to security of supply, our climate change commitments and, to the long term, to make sure we take the necessary action. There is not a do-nothing option."


Mr Johnson said by 2020 coal and nuclear generating electricity plants producing 30% of UK electricity will have closed. "Companies will need to decide how this capacity should be replaced. These are big investment decisions so the government needs to provide a clear framework," he said. While renewable sources of energy would be an element towards filling that gap, he said the security of oil and gas supplies from overseas had to be considered, especially in the light of the recent dispute between Russia and Ukraine.

Look beyond the end of your nose, Mr Johnson.

"If gas, as well as renewables, were to fill the gap, how comfortable will we be relying on imports for 80% of our supplies?" he asked.

And when the imports end as the resource has run out?

The World is a very confused place.

Genes record orangutans' decline

Deforestation has had a huge impact on orangutan numbers. The dramatic collapse of orangutan populations has been linked to human activity, new genetic evidence shows.

Ironically, the orangutan is one of the three species (along with chimpanzee and Human) that has self-awareness. And the claim is that the Human species is responsible for the orangutan's impending demise.

Researchers report that a population crash occurred during the past 200 years, coinciding with deforestation in the same area. The study focuses on orangutans found in the forests of Kinabatangan Wildlife Sanctuary in Malaysia. Writing in the journal Plos Biology, researchers suggest that the outlook is "bleak" unless urgent action is taken.

The team looked at 200 orangutans living along the Kinabatangan river. These animals are confined to fragmented patches of forest. By collecting the orangutans' hair and faeces, the researchers were able to extract DNA to create genetic profiles, which could then be used to study genetic diversity of the population, which shows a very strong signal of a massive population decline," he said. "This was interesting because we didn't expect it to show that the decline has happened so recently - within the last 200 years."

The period in which the population collapse occurred correlates strongly with the time that post-colonial habitat exploitation began in the region.

When north Borneo became part of the British Empire in the late 19th Century, deforestation began in earnest. In recent years, conservationists have linked the orangutans' decline to forest clearance for palm oil plantations, which produce the raw materials used for products like lipstick and soap. However, the Malaysian authorities told the BBC in November that the plantations were mainly grown on land that had already been cultivated or in "secondary jungle". Environmental impact studies were also carried out before any plantations were established, they added.

Orangutans numbers are now put at just 50,000, according to The World Atlas of Great Apes and their Conservation which is published by the UN's environment and biodiversity agencies. Professor Bruford warns that the animals' habitat needs to be better preserved, and that steps should be taken to re-establish corridors between fragmented forest patches.

He says it may even be necessary to move orangutans around to prevent inbreeding.

"The important thing you have to remember is that Kinabatangan is just one area, but these problems are significant in all orangutan ranges. If we don't put these changes in place throughout, then the outlook is really very bleak indeed," he urged.

Sentences to 'mean what they say'

New proposals to end the automatic early release of prisoners have been published by the Sentencing Commission. But some prisoners would still be able to serve less than the full term if they were closely supervised in the community, including being tagged.

The commission's chairman said the reforms were designed to put forward a system in which the sentences imposed by the courts would mean what they say.

Lord Macfadyen said they would bring much-needed clarity in sentencing.

But he warned that the proposals were not intended to increase the severity of sentencing and should not be regarded as a 'back door' opportunity to make Scotland a more penal society.

Ministers will now consider the detailed implications of the recommendations and publish their proposals in the late spring ahead of the introduction of a Sentencing Bill later this year. At present, prisoners sentenced to less than four years are released without conditions after serving half their term. Those sentenced to longer periods are freed on licence after completing two thirds of their sentence, though they can get out earlier on the Parole Board's recommendation.

A new regime for those sentenced to terms of more than 12 months involving the offender serving the whole of a minimum period, fixed by the court, in jail. After that most would then serve a further part of their sentence in the community.

Release at the end of the custodial part would depend on the prisoner being assessed as posing an acceptable risk (!!) to the community.

Those sentenced to less than 12 months could be released from prison on electronically-monitored Home Detention Curfew after not less than half the term has been served. Those passing sentence should explain what it means in terms of the minimum time to be served in custody and that which may be served in the community. It should be made explicit that the prison term should be the minimum period required to be served to satisfy the criminal justice requirements of punishment and deterrence and the protection of the public.

Sounds very laudable, I just don't believe the sincerity of any of it. Very politicised. But then, this is Scotland. What is the Blair influence to ruin everything? He has Scottish ancestry.

Lord Macfadyen said that the topic of early release was identified by the Scottish Executive as a top priority when it set up the commission in November 2003. He said: "Our review of this complex area of our law has been thorough. We consider that the keys to improving this aspect of our criminal law are simplicity and clarity. We also believe that the greater transparency which we are recommending should help create a regime that is understandable. Such understanding is vital if confidence in this aspect of our criminal justice system is to be restored and maintained."

Lord Macfadyen said that the recommendations were designed to put forward a system in which the sentences imposed by the courts would mean what they say. Justice Minister Cathy Jamieson said: "We are committed already to ending automatic early release and replacing it with a new regime that the public, particularly victims, can understand. A system that, as well as punishing the offender, will allow for a sentence that can be tailored to the offender's risk and needs in a way that will enhance public protection and reduce re-offending. The commission's report makes a valuable contribution towards achieving our goal."

Overall, rather more useful, in principle, than anything ever released into England.

Frozen into the future

Some 1,000 members of the "cryonics" movement, have made arrangements to have their body frozen in liquid nitrogen as soon as possible after death. Such is the hope to be revived sometime in the future when medicine has advanced far beyond where it stands today.


Mr Pizer from Arizona has left his money to himself so he won't "be revived in poverty". That assumes the funds of the present are sufficient to cover the needs of an unquantifiable future. With the help of an estate planner, Mr. Pizer has created legal arrangements for a financial trust that will manage his roughly $10 million in land and stock holdings until he is re-animated. Mr. Pizer says that with his money earning interest while he is frozen, he could wake up in 100 years the "richest man in the world."

Such trust. Such belief. It's truly ironic that someone who thinks like this - totally selfishly - imagines everyone else is unlike him! The double standards and hypocrisy are really quite breathtaking. He should convert all assets to gold stock as in 100 years' time it could all otherwise be valueless.

Though cryonic suspension of human remains is still dismissed by most medical experts as an outlandish idea, Mr. Pizer is not alone in hoping to hold onto his wealth into the frosty hereafter. "I figure I have a better than even chance of coming back," says Don Laughlin, the 75-year-old founder of an eponymous casino and resort in Laughlin, Nev. Mr. Laughlin, who turned a down-and-out motel he bought in 1966 into a gambling fortune, plans to leave himself $5 million.

Some 142 human bodies or heads, including that of baseball legend Ted Williams, are now held in cold-storage at one of two U.S. cryonics facilities, Alcor Life Extension Foundation in Scottsdale Ariz., and the Cryonics Institute of Clinton Township, Mich.

No one knows just what future technology may bring, or what form a new existence could take. Mr. Laughlin confronted that issue in a meeting last August with his lawyers while drafting a trust. Mr. Laughlin opted against allowing a mere biological clone to get his money. He insisted whoever gets the funds should have "my memories". Since people like Mr. Laughlin may rest in icy slumber for hundreds of years, protecting their assets from the living is apt to be a key challenge. After all, even the most standard of trusts have long been susceptible to dishonest managers -- not to mention challenges from disgruntled heirs.

This sadly is to be expected:

When Jakob P. Canaday, a Florida investor, died in 2004 of throat cancer, he left behind plans to stash his millions in a long-lasting trust with directions that he would recoup the money if and when his "human remains are revived and restored to life", according to court documents. On the eve of Mr. Canaday's death, however, his two daughters produced a new will, which left his fortune to them.

Such is greed.

Now there's a lawsuit pending in Broward County, Fla., Circuit Court. Mr. Canaday's brother, Siesel "Bud" Canaday, a retired Wall Street bond trader, says his sibling always wanted to be frozen and insists that the second will is not valid. No matter how bizarre his brother's choices may be, Mr. Canaday says, "it's tradition to honor the will of the deceased."

Wake up.

Daughter Michelle Canaday declined to comment on the case.

In Arizona, Mr. Pizer says he hopes his wife will join him in cryonic storage. And even if his trust money is somehow lost or stolen during his time on ice, he'll be content just as long as he returns to life.

What? Who's he kidding?

If he does, he says he'd use the opportunity to work hard and create new businesses. "I made it the first time from nothing, and I could do it again."

Nobody will care - all contempories'll be dead. Anyway, a dead challenger is no challenger. Why would the current generation want anyone like this around?

The thawing out is the real problem. Money can't facilitate this. To warm up a body so, so gradually and uniformly is certainly currently not possible. Any minor differences in a warming rate throughout the entire organism would result in fatality.

The cryonic storage companies won't tell you that.

Not the desired outcome.

With this, you can begin to understand what drives greed.

It's nasty and quite disgusting.

In a word: madness.

TV 'sleep' button stands accused

Apparently, the average household has up to 12 gadgets on standby or charging. Leaving TV sets and other gadgets on standby wastes the equivalent of around two power stations' worth of electricity each year. Around 800,000 tonnes of carbon are released as a result of "sleep mode".

Energy efficiency groups are urging people to carry out their own personal energy review because homes are set to place an ever increasing demand on power supplies - cost notwithstanding!

The number of TVs in the UK is estimated to reach 74 million by 2020, meaning that there will be more televisions than people to watch them.

The TV of the future will probably be the TFT-type (thin film transistor) screen or some other advancement. These are low voltage devices, but require a transformer running on 240V to step-down to the working voltage. The upshot is that placing on standby would make a lot less difference to actually being "on".

High-fi, video, DVD and computers etc are lower energy consuming devices (no CRT), so the difference between "on" and "standby" is consequently less. Essentially, "on" all the time.

It was a parliamentary question by Norman Baker (Liberal Democrat's environment spokesman) to the Department for Environment, Food and Rural Affairs (Defra) that led to the admission over emissions. Manufacturers include sleep modes on their products because it is what their customers want, says Matthew Armishaw from the Market Transformation Programme (MTP).

(I've never been asked. Have you?)

"For most products, it is purely consumer-driven; it is not a technical issue."

"Most set-top boxes need to have power all of the time because they download information from digital transmissions that update their electronic programme guide and software." Set-top boxes are becoming a common fixture in most homes across the UK because of plans to switch off the analogue TV signal in the near future.

STANDBY EMISSIONS. Estimated annual CO2 emissions from devices left on standby:

Stereos - 1,600,000 tonnes
Videos - 960,000 tonnes
TVs - 480,000 tonnes
Consoles - 390,000 tonnes
DVD players - 100,000 tonnes
Set-top boxes - 60,000 tonnes
(Source: Energy Saving Trust)

Norman Baker favours a "polluter pays" approach to the standby problem: "In the end, there has to be costs in the form of manufacturers paying something to recognize the damage they are causing.

This, of course, translates to "consumer pays". A tax rather than fixing the problem at source.

Some of these standby modes for televisions use two-thirds of the electricity that it would if it were on. "I think some (most?) people think that standby is a tiny red dot that has no impact at all."

The Energy Saving Trust's survey found that one-in-seven people questioned thought putting devices on standby was actually more energy-efficient than switching them on and off. [Less damaging to the device, though.] The MTP's Matthew Armishaw clears up any confusion: "That is largely a myth. There may have been some issues with very old electronic components [most TVs?], but it is certainly not the case with today's consumer electronic goods."

I would venture that the old cathode ray tube TV (probably still in the majority of TVs) would consume substantially less power than the TV "tube" as it isn't being energised. A very high voltage (around 20,000 volts) is necessary to drive the tube.

Head teacher guilty of bullying and more...

Richard Wealthall has been banned from running any school. A successful head teacher, who was praised by the Prime Minister Tony Blair, has been banned from ever running a school again. The General Teaching Council found Richard Wealthall guilty of professional misconduct while at St Clement's High School, Norfolk.

They found charges against him of bullying and nepotism to be proved. They also said he had used school funds to support fundraising activities by his family.

How low can he get? How can this ever be described as a "successful" head teacher? Sounds more like a complete failure. Unless, of course, it's in a Blair defense. He had been praised by the prime minister. Can't be seen to do wrong. Spin? I think a crude attempt.

The council added that Mr Wealthall, from King's Lynn, had also used the school mobile phone for personal use and failed to report to governors details of staff turnover.

Barbara Hibbard, chair of the council's committee, said Mr Wealthall had allowed his personal life to affect his decisions when employing his wife, daughter, son-in-law, and two family friends. She said it was also proved that Mr Wealthall, 60, had used "bullying and intimidating behaviour. It was an extremely autocratic and domineering style, such an atmosphere is not capable of allowing a school to thrive," she said.

In 2000 the school, in Terrington St Clement, near King's Lynn, was named one of the most improved comprehensive in England. Mr Blair said at the time that Mr Wealthall's work was "an example to the rest of the country". The school governors issued a statement saying: "The issues for the school were nearly three years ago.

"The school, under the leadership of a new head teacher since January 2004, has put the matter behind it and moved on."

Mr Wealthall, who is now retired and lives in the south of France, denied all the allegations.

The headteacher was not at the hearing for the outcome of the case in Birmingham that started last year. His lawyer Simon Thomas said: "Mr Wealthall accepts the decision of the committee and regrets that it has appeared he has upset valued former colleagues.

"Not withstanding this decision, Mr Wealthall asks that the considerable improvements made to the school during his period of headship be remembered."

And how long is that list of improvements? And where is it? Wealthall is (retired) in France and not present to answer the allegations that he denies.

News for you Mr Wealthall: whatever earlier achievements are alleged to have been, when you FUCK UP, that's what's remembered. And, of course, everything becomes tarnished and discredited anyway.

Sounds a decent sort of chap, eh?


Mother loses 'right to know' case

A mother has lost her court battle for a parent's "right to know" if girls are being advised on abortion. Sue Axon, 51, of Baguley, Manchester, wanted the law changed to prevent girls under 16 getting confidential advice. Mrs Axon said she regretted having an abortion 20 years ago that caused her "guilt, shame and depression". But the High Court rejected a review of guidelines which state terminations do not need parents' consent and doctors should respect girls' confidentiality.

Presumably, advice translates to "how to get an abortion".

Respect "confidentiality". Disregard long-term health and welfare. After all, these are only doctors. What do they know? When compared to a High Court judge. They know it all, of course! Mr Justice Silber, sitting in London, said Mrs Axon, or any other parent, had no right to know unless the child decided otherwise. "Forcing a girl to tell her parents may lead her to make a decision that she later regrets or seek the assistance of an unofficial abortionist", he added.

A forced decision she later regrets by NOT having an abortion? Isn't that a rather perverse argument? Spin as they say.

But the judge also warned that abortions should not be made available if the young person lacked the maturity to understand all the advice they were given.

And how will that be assessed? A potential immaturity to understand the advice, but obviously mature enough to have the baby and look after it. Where do these people come from? The legal profession getting itself tied up in knots again. Painting itself into a corner. Then rig up a messier "get-out" from the mess.

Mrs Axon's QC Philip Havers had told Mr Justice Silber she did not say that doctors could not carry out treatment without parents' consent but that she had the right to be notified. Mrs Axon believes current guidelines "undermine" her role as a parent and infringe her parental rights under the European Convention on Human Rights.

Seems reasonable.


Philip Sales, appearing for the health secretary, had told the judge her arguments had "absolutely no foundation in law".

At a hearing in November, he said the UK had "a very serious problem" with high teenage pregnancy rates - and confidentiality was a key component of government policies to reduce conception rates and improve sexual health.

How does that work? I don't follow any logic there.

Smacks of sweeping under the carpet. Place in the shadows so the problem isn't seen. If the problem can't be seen, the problem doesn't exist! Right? It sweeps away the under-age sex and the legality issue. It reduces the number of births, mostly illegitimate, since they are aborted. It increases the numbers of damaged and traumatised young girls - doesn't effect young males in any such way: nothing to do with me guv! - and it fails absolutely to even attempt to control sexually transmitted diseases.

In fact, it does nothing less than makes a bad situation even worse.

That comment by Sales about "absolutely no foundation in law" is a very pompous and extremely unhelpful one. No surprises there - it comes from the health secretary's department. An assertion that has "absolutely no foundation in common sense".

I must be missing something else here: I always thought that the law defined statutory rape as sex under the age of 16. The morals of that does not enter the equation here. But this legal problem is always dodged. The fact that a child under 16 is pregnant defines the situation. This is not talking about parthenogenesis where sex isn't necessary to procreate. It takes two to tango! Under age sex is illegal, but no mention of this. The whole issue is very conveniently dodged.

The suggestion that children under 16 have the maturity to deal with this is based upon a really crappy (and dangerous) premise. A child of 16 or less is immature. By the definition of having lived for only less than 16 years. Not enough time to develop real maturity. Physically girls of around 10 years old or so can have babies. The maturity necessary to raise a child is somewhat older to be able to do this independently. It probably happens, but is very rare.

A physical maturity doesn't imply mental maturity.

The Monsanto Files. BE VERY AFRAID.

The Ecologist September October 1998
(This edition was trashed by the printing office after threats from Monsanto)

Revolving Doors: Monsanto and the Regulators
by Jennifer Ferrara

Traditionally, key figures at the FDA in particular have either held important positions at Monsanto, or are destined to do so in the future. Is it surprising therefore that Monsanto gets clearance for its often dangerous products?

Though the evolution of genetic engineering from a laboratory science to a method of creating commercial products happened very fast - within a decade - the US government saw the commercialisation of biotechnology coming and deliberately chose a path that has amounted to non-regulation. Genetic engineering broke through natural barriers of reproduction and sped up plant and animal breeding processes, but agribusiness corporations were wary that burdensome regulations would hinder new discoveries and therefore the commercial development of the technology. The federal government took up industry's cause. Instead of establishing strict, precautionary regulations that gave priority to public and environmental health, the government patched together an inadequate regulatory system that relied on risk assessment, industry science, and corporate volunteerism.

The US was in the heat of a high-tech economic race with Japan, and, as far as agriculture was concerned, lawmakers saw genetic engineering as the new technology that would allow the US to maintain its position as the world's agricultural "leader". The federal government would erect no law that might reduce America's competitiveness in the future world market for bioengineered products.

The first government body to establish guidelines for biotechnology research was the National Institutes of Health (NIH) in 1976[1]. Since the NIH is an advisory and not a regulatory body, it could formulate guidelines, but it had no power to enforce them. From the beginning, the NIH guidelines relied on the scientific community's and industry's self-regulation, starting a trend that continues today. As corporations became more involved in genetic engineering, NIH guidelines made accommodations for field tests and mass production of genetically engineered organisms.

In 1977 and 1978, 16 bills to regulate genetic research were introduced in the US Congress.

None was passed.

The NIH guidelines (dealing primarily with medical and pharmaceutical research and not taking a precautionary approach) remained the sole regulatory mechanism for biotechnology research.

In the early 1980s, agribusiness corporations were developing genetically engineered plants, animal drugs, and livestock, but no system was in place to regulate the development, sale, or use of these products[2]. This was the era of the deregulatory Reagan/Bush administration, which developed the framework by which bioengineered products, including food, are "regulated" today.

Industrial profit, not public safety, was the administration's top priority.

Government officials in the Office of Management and Budget, the Departments of State and Commerce, and the White House Office of Science and Technology Policy wanted to ensure that the administration did not do anything to "stifle" the dev[3]. The Bush-era President's Council on Competitiveness, chaired by Vice-President Dan Quayle, joined the biotechnology industry in opposing strong regulations and close oversight by federal agencies[4].

The result was a 1986 "biotechnology regulatory framework"[5].

The policy was founded on the corporate-generated assertion that bioengineering was just an extension of traditional plant and animal breeding, and that bioengineered products did not differ fundamentally from non-engineered organisms[6].

The administration determined that existing federal agencies could regulate bioengineered products sufficiently and gave them overlapping regulatory authority[7].

The Food and Drug Administration (FDA) would regulate bio-engineered organisms in food and drugs.

The United States Department of Agriculture would regulate genetically engineered crop plants and animals.

The Environmental Protection Agency would regulate genetically engineered organisms released into the environment for pest control.

The NIH would look at organisms that could affect public health.

In determining that existing agencies could do the job of regulating bioengineered products, the administration avoided passing new, more stringent federal laws or establishing a new regulatory agency devoted to the task.

The policy left gaping communication gaps between agencies, plenty of regulatory ground uncovered, and confusion over who would regulate what[8,9].

But most importantly, the regulations were founded on the false premise that bioengineered organisms used for food and agricultural products are no different from non-engineered, conventional products[10].

In fact, to produce genetically engineered foods, researchers take genes from food or non-food organisms and add them to another organism to alter its genetic makeup in ways not possible through sexual reproduction.

The process deletes essential proteins or adds entirely new ones, and can modify genetic characteristics in entirely unexpected ways.

As long as the new genes come from an approved food source, the government treats new or altered genes in bioengineered foods as natural, not novel, additives. So in most cases regulators are not required to take a precautionary approach when evaluating new genetically engineered food products; products are considered safe until proven otherwise.

As late as 1994, it appeared that the federal government was still playing catch-up in establishing working biotechnology safety regulations. The Union of Concerned Scientists (UCS), which monitors the biotechnology industry and the federal regulatory system, was pointing out big holes in the so-called framework.

"Fundamentally, it does not contain sufficient statutory authority to oversee all of the products and activities entailed in genetic engineering," wrote UCS in February 1994. "Where authority does exist, there are problems with implementing regulations and policies."

For example, a 1992 FDA policy exempted corporations from having to test bioengineered food for safety and get FDA approval before the foods are put on the market. Unless the corporation determined that "sufficient safety questions exist", corporations could undergo voluntary, private "consultations" with the agency before marketing their product.

It is not unusual for agribusiness corporations like Monsanto to manipulate the limited safety regulations that exist. To establish safety standards for new products, federal agencies rely on studies performed by the very corporations that are trying to get their products on the market. Studies to determine the long-term health consequences of new products are not always required. Over the years, many corporations have submitted fraudulent test results showing that their products are safe, or they have simply withheld information or studies indicating otherwise.

Because the federal government protects corporate safety studies as trade secrets, they are not available for public scrutiny. By sheltering corporations in this way, federal agencies hold corporations' pursuit of profits above the public's right to good health and a safe environment.

The Regulatory Irony

Laws governing biotechnology continue to favour agribusiness and biotechnology corporations, but as the industry has developed, the corporate push for specific types of regulations has taken ironic twists. The initial lack of a cautious regulatory approach enabled small biotechnology companies to develop and market new bioengineered products at a rapid pace. In the meantime, larger agribusiness corporations like Monsanto and Ciba-Geigy were buying up these small companies while developing their own expansive in-house biotechnology research and marketing operations. During this time, Monsanto, Ciba-Geigy, and several other agribusiness corporations came virtually to dominate the world market for bioengineered food products, strengthening their hold over much of the world's food supply.

From their position at the top, Monsanto and other corporations have actually favoured some seemingly tight regulations, but, it turns out, only when the regulations serve corporate marketing purposes.

Regulations that require corporations to submit a plethora of costly scientific data to regulatory agencies, for example, discourage competition from smaller biotechnology and seed companies while giving the public the illusion that new biotechnology products undergo rigorous safety evaluations and are therefore safe.

In 1995, for example, Monsanto lobbied against a provision in the EPA funding bill that would have prevented the EPA from regulating agricultural plants bioengineered to contain the toxic bacterium Bacillus thuringiensis (Bt). Genetically engineered foods had just hit the market, and Monsanto was fully aware that almost any EPA regulations for Bt plants would publicly sanction the genetically engineered products and defuse resistance from public interest environmental groups. Furthermore, corporations could only get their Bt products to market if they had extensive money and resources to jump through all the regulatory hoops.

Big corporations alone can meet data requirements and, once in the system, manipulate and pass the EPA's safety evaluation process. With the competition out of the way, the market is theirs.

FDA Scandals and Revolving Doors

To better understand how genetically engineered foods and the associated safety hazards were unleashed onto the American public, take a look at the story of the first mass-marketed bioengineered food product, the Monsanto corporation's recombinant bovine growth hormone (rBGH). rBGH has been linked to cancer in humans and serious health problems in cows, including udder infections and reproductive problems. rBGH's development and approval was rife with scandal and protest.

But the right combination of government backing, corporate science, and heavily-funded corporate public relations schemes paved the way for the first major release of a genetically engineered food into the nation's food supply.

The roles played by the FDA and the Monsanto corporation in the development, safety evaluation, approval, and marketing of rBGH led to the exposure of the American public to the multiple hazards of bioengineered foods.

These organizations hid important information about safety concerns, masked disturbing conflicts of interest, and stifled those who were asking the "wrong" questions and telling the truth about rBGH.

The FDA declared rBGH-milk safe for human consumption before important information about how rBGH-milk might affect human health was even available.

When critical information about how rBGH raised the levels of insulin-like growth factor, IGF-1, in milk and the possible link between IGF-1 and human cancer began to emerge, the FDA was already apparently in too deep to change its mind or ask more questions about the drug's effect on human health.

Instead, the agency relied almost exclusively on data generated by the Monsanto corporation and highly criticized by independent scientists to justify a decision it had made years before. Many independent scientists have called for more extensive, long-term studies, which have never been done.

In 1991, a researcher at the University of Vermont (UVM), where Monsanto was spending nearly half a million dollars to fund test trials of rBGH, leaked information about severe health problems affecting rBGH-treated cows, including mastitis and deformed births. The scientist heading the research had already made numerous public statements to state lawmakers and the press and released a preliminary report indicating that rBGH-treated cows suffered no abnormal rates of health problems compared with untreated cows. The US General Accounting Office (GAO) investigated. During the investigation, the FDA stalled in providing the GAO with original Monsanto test data and the GAO was unable to obtain critical data from UVM and Monsanto. The GAO terminated its investigation, concerned that Monsanto had had time to manipulate the questionable data and that any further investigation would be fruitless. In an effort to dissipate public concern, UVM scientists finally released information showing rBGH's negative effect on cow health, years after the findings had been made."

Even FDA insiders have criticized the agency for its slack review of the drug, but the FDA has dismissed these concerns and fired at least one official who blew the whistle on the organisation's corrupt drug approval process. Veterinarian Dr. Richard Burroughs reviewed animal drug applications at the FDA's Center for Veterinary Sciences from 1979 until he was fired in 1989.

[Note: Dr. Burroughs exemplifies integrity and good science.]

In 1985, Burroughs headed the FDA's review of rBGH and remained directly involved in the review process for almost five years. Burroughs wrote the original protocols for animal safety studies and reviewed the data that rBGH developers, including Monsanto, submitted as they carried out safety studies.

A 1991 article in Eating Well magazine quotes Burroughs describing a change in the FDA beginning in the mid-1980s. "There seemed to be a trend in the place toward approval at any price. It went from a university-like setting where there was independent scientific review to an atmosphere of "approve, approve, approve." This is the atmosphere in which the FDA carried out its review of rBGH. According to Burroughs, the FDA was totally unprepared to review rBGH, the first bioengineered animal drug to go through the FDA's approval process; rBGH was out of the scope of most FDA employees' knowledge. But rather than admit incompetence, the FDA "decided to cover up inappropriate studies and decisions," and agency officials "suppressed and manipulated data to cover up their own ignorance and incompetence."

Burroughs himself was faced with corporate representatives who wanted the agency to ease strict safety testing protocols, and he saw corporations drop sick cows from rBGH test trials and manipulate data in other ways to make health and safety problems disappear. According to Burroughs, the raw, untouched data stashed away behind the agency's doors and protected as trade secrets would show otherwise.

Burroughs challenged the agency's lenience and its changing role from guardian of public health to protector of corporate profits. He criticized the FDA and its handling of rBGH in statements to Congressional investigators, in testimony to state legislatures, and to the press. Inside the FDA, he rejected a number of corporate-sponsored safety studies as insufficient and was prevented by his superiors from investigating data submitted by industry revealing possible health problems caused by rBGH.

Though Burroughs had a record at the FDA showing eight straight years of good performance, he began receiving poor performance reports, for which he claims he was set up. Finally, in November 1989, he was fired for "incompetence".

Not only did the FDA fail to act upon evidence that rBGH was not safe, the agency actually promoted the Monsanto corporation's product before and after the drug's approval. In doing so, the FDA took on the impossible double role of regulator and promoter of bioengineered foods. Dr. Michael Hansen of Consumers Union notes that the FDA acted as an rBGH advocate by issuing news releases promoting rBGH, making public statements praising the drug, and writing promotional pieces about rBGH in the agency's publication, FDA Consume.

This dual role also manifested itself in other ways. In an apparent attempt to quell public controversy over rBGH, for example, two FDA researchers published industry and "independent" data in the journal Science in 1990 to show that rBGH was safe for consumers.

Gerald Guest, the director for FDA's Center for Veterinary Medicine told Science, "We'd like to get our side of the story out, to show why we're comfortable with the safety. We'd like for people to know that it's a thoughtful process and we want it to be open and credible."

Guest was apparently doing a lot of wishful thinking. Professor Samuel Epstein criticized the FDA for acting

"as a booster or advocate for an animal drug that hasn't yet been approved."

Epstein and others faulted the FDA for including only pieces of unpublished studies about rBGH in the Science article, but not making the full studies available for independent review.

The FDA's pro-rBGH activities make more sense in light of conflicts of interest between the FDA and the Monsanto corporation.

Michael R. Taylor, the FDA's deputy commissioner for policy, wrote the FDA's rBGH labelling guidelines. The guidelines, announced in February 1994, virtually prohibited dairy corporations from making any real distinction between products produced with and without rBGH. To keep rBGH-milk from being "stigmatized" in the marketplace, the FDA announced that labels on non-rBGH products must state that there is no difference between rBGH and the naturally occurring hormone.

In March 1994, Taylor was publicly exposed as a former lawyer for the Monsanto corporation for seven years. While working for Monsanto, Taylor had prepared a memo for the company as to whether or not it would be constitutional for states to erect labelling laws concerning rBGH dairy products.

In other words Taylor helped Monsanto figure out whether or not the corporation could sue states or companies that wanted to tell the public that their products were free of Monsanto's drug.

Taylor wasn't the only FDA official involved in rBGH policy who had worked for Monsanto.

Margaret Miller, deputy director of the FDA's Office of New Animal Drugs was a former Monsanto research scientist who had worked on Monsanto's rBGH safety studies up until 1989.

Suzanne Sechen was a primary reviewer for rBGH in the Office of New Animal Drugs between 1988 and 1990. Before coming to the FDA, she had done research for several Monsanto-funded rBGH studies as a graduate student at Cornell University. Her professor was one of Monsanto's university consultants and a known rBGH promoter.

Remarkably, the GAO determined in a 1994 investigation that these officials' former association with the Monsanto corporation did not pose a conflict of interest.

But for those concerned about the health and environmental hazards of genetic engineering, the revolving door between the biotechnology industry and federal regulating agencies is a serious cause for concern.

Original citation: Published with permission of The Ecologist

When Advocates Become Regulators

Published on Sunday, May 23, 2004 by the Denver Post

President Bush has installed more than 100 top officials who were once lobbyists, attorneys or spokespeople for the industries they oversee.
by Anne C. Mulkern

WASHINGTON -- In a New York City ballroom days before Christmas, a powerful Bush administration lawyer made an unprecedented offer to drug companies, one likely to protect their profits and potentially hurt consumers.

Daniel E. Troy, lead counsel for the U.S. Food and Drug Administration, extended the government's help in torpedoing certain lawsuits. Among Troy's targets: claims that medications caused devastating and unexpected side effects.

Pitch us lawsuits that we might get involved in, Troy told several hundred pharmaceutical attorneys, some of them old friends and acquaintances from his previous role representing major U.S. pharmaceutical firms.

The offer by the FDA's top attorney, made Dec. 15 at the Plaza Hotel, took the agency responsible for food and drug safety into new territory.

"The FDA is now in the business of helping lawsuit defendants, specifically the pharmaceutical companies," said James O'Reilly, University of Cincinnati law professor and author of a book on the history of the FDA. "It's a dramatic change in what the FDA has done in the past."

Troy's switch from industry advocate to industry regulator overseeing his former clients is a hallmark of President Bush's administration.

Troy is one of more than 100 high-level officials under Bush who helped govern industries they once represented as lobbyists, lawyers or company advocates, a Denver Post analysis shows.

In at least 20 cases, those former industry advocates have helped their agencies write, shape or push for policy shifts that benefit their former industries. They knew which changes to make because they had pushed for them as industry advocates.

The president's political appointees are making or overseeing profound changes affecting drug laws, food policies, land use, clean-air regulations and other key issues.

Government watchdogs call it a disturbing trend, not adequately restrained by existing ethics laws.

Among the advocates-turned-regulators are a former meat-industry lobbyist who helps decide how meat is labeled; a former drug-company lobbyist who influences prescription-drug policies; a former energy lobbyist who, while still accepting payments for bringing clients into his old lobbying firm, helps determine how much of the West those former clients can use for oil and gas drilling.

"When you go to work in lobbying, it is clearly understood and accepted that your job is to advocate for the interests of those who hired you," said Terry L. Cooper, a University of Southern California ethics and government professor. "When you go to work in government, you are supposed to be responsible for upholding and maintaining whatever you can identify as the public interest."

The Bush administration says the regulators were chosen for their abilities.

"The president appoints highly qualified individuals who make their decisions based on the best interests of the American people," said White House spokesman Jim Morrell. "Any individual serving in the administration must abide by strict legal and ethical guidelines, including full disclosure of past lobbying activities."

Six of the former industry advocates have faced ethics investigations or resigned amid conflict-of-interest charges. Those and at least 14 others have been lambasted by public-interest groups.

Government ethics standards are part of the problem because they don't fully address the kind of issues that now permeate Washington, Cooper and some inside government say. The rules focus mainly on direct financial conflicts. Other, more nuanced conflicts aren't addressed

"There are so many ways around, over and under these (ethics) bans ... they almost never work," said Paul Light, who for decades has studied the appointment process for the Brookings Institution, a think tank in Washington. "There're more screen doors than steel doors."

A March 16 report from the Interior Department's inspector general, for example, concluded that department's "byzantine" conflict-of-interest rules were "wholly incapable" of addressing ethical questions involving a former energy lobbyist, J. Steven Griles, as the department's No. 2 official.

The report called the department's ethics system "a train wreck waiting to happen."

Bringing bias to a federal job isn't new. Presidents of all political persuasions have appointed people who shared their party's values.

As president, Bill Clinton peppered the federal bureaucracy with Democratic state officials, lawyers and advocates from various environmental or public-interest groups.

Only a handful of registered lobbyists worked for Clinton, however.

Bush's embrace of lobbyists marks a key difference because it allows "those who are affected by the regulations to determine what the ground rules should be," said David Cohen, co-director of the Advocacy Institute, which helps teach nonprofits how to lobby in Washington.

While previous Republican presidents hired lobbyists, "the Bush administration has made it rise in geometric proportions," Cohen said, meaning Bush is "capturing the instruments of government and using them for the ends" that favor Bush's political supporters.

"In the Bush administration," said U.S. Sen. Joe Lieberman, D-Conn., "the foxes are guarding the foxes, and the middle-class hens are getting plucked."

Republicans and their lobbying allies reject the idea that industry is embedded in the administration.

"Foxes? No," Vice President Dick Cheney told The Denver Post. "I think we have a good track record."

The clout of industry is balanced by the power of labor unions, trial lawyers and public-interest groups, said Jerry Jasinowski, chairman of the National Association of Manufacturers.

"The notion that somehow business gets everything and we've gotten a free ride is absurd," he said.

Still, the lobbyists-turned-policymakers control or influence health care, food safety, land use, the environment and other issues touched by government.


Ann-Marie Lynch

The drug-industry lobbyist who fought price controls joined the Health and Human Services Department and has helped drug companies avoid the limits.

Top aides in the Department of Health and Human Services provide analysis and advice to the president on key consumer issues, including prescription-drug policies. In doing so, they consider the needs of pharmaceutical companies seeking revenue for future research, and consumers struggling to afford increasingly costly medications.

In June 2001 Bush installed Ann- Marie Lynch, a lobbyist for the drug- company trade group Pharmaceutical Research and Manufacturers of America, to help set those policies.

As a lobbyist, Lynch fought congressional attempts to cap prices for drugs. Price controls, she argued, would hamper medical innovation.

Thirteen months after Lynch became deputy assistant secretary in the office of policy, her division issued a report that praised brand- name drugs. It warned that "government-controlled restrictions on the coverage of new drugs could put the future of medical innovation at risk and may retard advances in treatment."

Consumer advocates say that's nonsense. Other countries innovate despite price controls, said Gail Shearer, director of health policy analysis for Consumers Union, nonprofit publisher of Consumer Reports.

"They haven't taken as seriously their job of making medicines affordable to all Americans," Shearer said. "When you talk about the need for (drug) innovation, you have to put it in the context of, will people get the wonder drugs?"

Critics say the report influenced congressional debate over a Medicare drug policy that, among other things, banned government from using Medicare's buying power to cut drug prices. The legislation will mean an extra $139 billion in profit over eight years to drug companies, Boston University researchers said.

Republicans in Congress used arguments that came "directly out of Ann-Marie Lynch's mouth" and from the trade group she previously worked for, said Rep. Sherrod Brown of Ohio, lead Democrat on the Energy and Commerce Committee's health subcommittee.

Lynch declined to talk to a reporter. HHS spokesman Bill Pierce said the report was not intended to sway Congress. Provisions banning Medicare from negotiating drug prices date to 2000, he said.

Lynch also blocked the release of about a dozen completed research reports that challenge drug-company claims, three former employees said. Pierce said Lynch decides research topics and which reports are released.

One 2001 report, for example, criticizes Medicare plus Choice (now known as Medicare Advantage). Its findings suggested that running the Medicare prescription-drug benefit through private health companies - the method the administration ultimately chose - would be more expensive and would not serve rural areas well.

"Very few of (the private companies) manage to bring in the benefit cost effectively," said Mark Merlis, the private health policy consultant who wrote the report.

Thomas A. Scully

The former hospital lobbyist presided over an agency that helped a chain he once represented win a favorable settlement in a Medicare fraud case.

Thomas A. Scully represented the nation's for-profit hospitals as a lobbyist before being hired by the Bush administration in June 2001 to head the federal Centers for Medicare & Medicaid Services.

Eight months after Scully arrived at the Medicare and Medicaid agency, it moved to settle final claims involving HCA Inc., a hospital chain that was the biggest member of Scully's former employer, the Federation of American Hospitals. HCA Inc. faced allegations it fraudulently overbilled the government for Medicare cases.

Under the terms agreed to in June 2002 by Scully's agency, HCA would have settled for $250 million. Medicare fraud cases typically are ironed out with Justice Department participation, but Scully agreed to those terms on his own, said John R. Phillips, an attorney who represented whistle-blowers in the case.

"The $250 million was a total sellout by Scully, who totally negotiated it behind Justice's back," Phillips said.

It also was handled in a way that protected the company from a full review of its cost reports and the triple- damage civil fines that can be imposed in fraud cases, he said.

Sen. Charles Grassley, R-Iowa, asked Justice in October 2002 if that deal was "too lenient."

Justice delayed the settlement until June 2003.

HCA, the nation's biggest for-profit hospital company, eventually paid that $250 million, plus $631 million in civil penalties and damages and $17.5 million to states.

Scully's ethics agreement did not require him to officially avoid cases involving HCA. But Scully said he steered clear.

"I recused myself from everything involving HCA-specific issues or policy and was not involved in any way, shape or form," Scully said. "Every time anything came up (regarding) HCA, I left it to my deputies."

But Grassley in a June 25, 2002, letter to a Justice Department lawyer said comments by Scully "have given me great concern that there is an active, ongoing effort underway to change or modify enforcement (on Medicare fraud) policy that in my view could significantly undermine the (law)."

Scully has since left the administration for consulting jobs with a lobbying firm and an investment company that represent Medicare providers.

Daniel E. Troy

The lawyer who represented major drug companies still fights for causes that benefit them as chief counsel at the Food and Drug Administration.

Daniel E. Troy was well-known at the FDA before he arrived in summer 2001 to work as chief counsel, the top legal position in the department.

As a lawyer in private practice, Troy repeatedly sued the FDA, arguing that it had only limited ability to regulate drug companies. He filed those suits through the Washington Legal Foundation, a group funded by businesses, including drug companies. Donors include charitable foundations run by Pfizer Inc., Procter & Gamble Co. and Eli Lilly & Co.

Troy also represented Pfizer through his firm, Wiley, Rein & Fielding. Troy said in an e-mail to a reporter that his Pfizer work was mainly communications and insurance law, and averaged only 80 hours a year.

At the FDA, Troy still is fighting for causes that benefit drug companies.

It's unclear whether any of pharmaceutical firms responded to his December request for lawsuits the FDA might get involved in.

By the time Troy made that offer, he had already intervened in three drug-company cases as FDA chief counsel. One involved Pfizer.

In court briefs, the FDA argued that it determines which warnings a drug company must give consumers. Lawsuits filed in state courts arguing that drug-company warnings are inadequate therefore were invalid, the FDA says. One of the cases Troy challenged involves thousands of consumers who say they were harmed by painful withdrawal from an antidepressant.

Lawsuits accusing drug companies of telling consumers too little about side effects constitute the largest category of cases against drug companies, law professor O'Reilly said.

If Troy's legal position prevails, O'Reilly said, it would be catastrophic for consumers hurt by drugs. He said it would bar cases like the one filed against the makers of fen-phen, the combination of diet medications tied to heart problems. The makers of those drugs are settling with consumers for $14 billion. That case predates Troy's policy.

Troy, who declined to be interviewed, said in a written statement that the FDA is intervening in the lawsuits to protect "the safety, effectiveness and availability of important medical products."

He said that would be "adversely affected if judges and juries acting under state law had the power to substitute their judgment for the expert determinations made by FDA scientists."

Clinton's Justice Department, he added, took the same legal position, arguing that federal law pre-empts state law.

But prior to Troy, professor O'Reilly and one FDA official said, the government got involved only when a judge asked. Troy, in contrast, is seeking cases in which to intervene.

And the FDA now is staking a new legal claim, experts say: that its authority to determine drug labeling always trumps any claims made in state court.

The FDA is "taking sides in private litigation," said Thomas McGarity, a University of Texas Law School professor and president of the Center for Progressive Regulation, which supports government regulation on health and safety issues.

The FDA asks drug-company attorneys to alert the agency to cases because otherwise "our rules might be undermined by contrary state findings" the agency is unaware of, said Peter Pitts, an FDA spokesman.

He added: "For people to infer that (FDA) decisions are made with anything but the public health as our focus is untrue, unfair and very ill-considered."

FDA officials also say they want to discourage frivolous lawsuits, which drive up costs.

A former FDA chief counsel in the Nixon administration, Peter Barton Hutt, said he supported the FDA's legal position but added, "I probably wouldn't be out there encouraging" lawsuits.

Troy oversees other FDA changes that provoked accusations that he is siding with drug companies.

In October 2001, the Health and Human Services Department gave Troy's office final approval over warnings telling companies they could be in violation of FDA rules. Those had previously been sent out by the FDA's drug-marketing division and district offices.

After that change, the number of warnings of questionable claims by pharmaceutical companies quickly dropped from an average of seven a month to two.

FDA spokesman Pitts said fewer letters were sent because the process was centralized.

"If you torture statistics long enough," Pitts said, "they confess to anything."

Others see this as dangerous to the public.

"This ... may be a welcome development for the drug industry, but it poses serious dangers to public health," Rep. Henry Waxman of California, the top Democrat on the House Committee on Government Reform, said in an Oct. 1, 2002, letter to HHS Secretary Tommy Thompson.

Waxman said the bad policy decision was "exacerbated by the appointment of Daniel Troy."

The investigative arm of Congress, the General Accounting Office, in October 2002 also found that, under the new system, warning notices "have taken so long that misleading advertisements may have completed their broadcast life cycle before FDA issued the letters."

Waxman described the delays as "a development that benefits the powerful pharmaceutical industry at the expense of consumers."


Charles Lambert

As a USDA official, the former lobbyist for the meat industry who opposed labeling told a hearing that mad cow disease was not a threat.

Mad cow disease had yet to surface in the United States last June when a U.S. Department of Agriculture official - a meat-industry lobbyist only eight months earlier - bet his job on the promise that the ailment couldn't sneak into the country through imports.

Congress had just passed a law requiring meat labels to state which country a cow lived in before slaughter. Food safety groups say those labels could, among other things, help consumers avoid buying beef from countries with mad cow disease.

The USDA opposed such labeling. The person making the agency's case, Deputy Undersecretary Charles Lambert, knew the arguments against such labels. He'd made them as a lobbyist for the National Cattlemen's Beef Association.

Lambert spent 15 years at the Cattlemen's Association working in Denver before coming to Washington, D.C., where he worked as lobbyist and chief economist. He left in December 2002 to join the USDA as undersecretary for marketing and regulatory programs.

When asked about mad cow and the labels, Lambert said mad cow disease wasn't a threat.

"Is there a possibility that it could get through?" Rep. Joe Baca, a California Democrat, asked Lambert at a hearing last June.

Lambert answered, "No, sir."

"None at all?" Baca asked.

"No," Lambert replied.

"You would bet your life on it - your job on it, right?"

Lambert answered, "Yes, sir."

The disease was discovered in the U.S. six months later - apparently brought here by a cow from Canada.

Lambert now says, "I overstated my case."

More than a dozen other high-ranking USDA officials appointed under Bush also have ties to the meat industry.

"Whether it's intentional or not, USDA gives the impression of being a wholly owned subsidiary of America's cattlemen," said Carol Tucker Foreman, director of the Consumer Federation of America's Food Policy Institute. She served as a USDA assistant secretary in the Carter White House. "Their interests rather than the public interests predominate in USDA policy."

When he came to the USDA, Lambert signed an agreement stating that in his first year he would "not participate personally and substantially in any particular matter involving specific parties in which (Cattlemen's) is a party or represents a party, unless I am authorized to participate."

During that period he met at least 12 times with current or former members of Cattlemen's and its affiliates, an office calendar obtained by The Denver Post shows.

Lambert said that at any meeting where policy was discussed, he acted only as a facilitator and that another USDA person was present. The calendar shows meetings where other USDA people were present, although it is not always clear what was discussed.

The rest of those meetings were at social settings, he said.

"You're not required to sever all personal and past relationships ... when you come to federal employment," Lambert said in an interview.


Jeffrey Holmstead

The EPA official, a lawyer, formerly worked for a firm that represents utility companies, which are among the biggest air polluters.

When the Environmental Protection Agency issued proposed changes to air pollution rules Jan. 30, the wording troubled Martha Keating, a scientist with environmental advocacy group Clear the Air.

"It struck me that I had seen this before," Keating said.

At least 12 paragraphs were identical to or closely resembled a Sept. 4, 2003, proposal given to the Bush administration by Latham & Watkins, a law firm that represents utility companies.

The EPA official overseeing the proposed changes is Jeffrey Holmstead, who until he joined the EPA in October 2001 had worked as a lawyer at Latham & Watkins. His clients included a chemical company and a trade group for utility companies. Power plants are among the biggest air polluters.

Holmstead oversees the EPA division that governs air pollution.

Environmental groups say the rewrite poses a health threat because it slows the reduction of mercury emissions by as much as 11 years. Those emissions can end up in water where they contaminate fish. Forty-three states have issued advisories about fish consumption because of mercury pollution, the U.S. Public Interest Research Group said.

One effect of the proposal would be that 168 of 236 Western-based plants, including those in Colorado, would not be required to reduce those emissions at all, Keating said.

Lobbyists commonly suggest wording for legislation. But even EPA Administrator Mike Leavitt objects to how this language was lifted.

"To take something from a source without noting it doesn't seem to be the normal course of business, and it shouldn't have been done," EPA spokeswoman Cynthia Bergman said, speaking for Leavitt.

Holmstead declined to comment.

Six Democratic senators are asking for an investigation. Ten attorneys general and 45 senators - including three Republicans - have asked Leavitt to void the proposed rule because of undue industry influence.

The inspector general hasn't decided whether to investigate. Bergman said the final pollution rule is still under development.


J. Steven Griles

The tenure of the veteran energy lobbyist at the Interior Department was labeled an "ethical quagmire" by the agency's inspector general.

At the U.S. Department of the Interior, which oversees some 507 million acres of national parks, refuges and rangeland, top officials weigh the competing merits of resource conservation and development.

Bush named J. Steven Griles, a veteran energy industry lobbyist, as the department's second-highest official in June 2001.

Griles earned $585,000 a year as a lobbyist, representing an array of oil, gas and other energy interests. As Interior's deputy secretary, he continues to receive $284,000 a year for four years to pay him for the value he had created for the firm by bringing in clients.

Upon entering the government, Griles had pledged to remove himself from deliberations that affected his former clients.

This year, the department's inspector general called Griles' tenure an "ethical quagmire."

"Mr. Griles' lax understanding of his ethics agreement and attendant recusals, combined with the lax dispensation of ethics advice given to him, resulted in lax constraint over matters in which the deputy secretary involved himself," the inspector general concluded.

That report or a subsequent review by the U.S. Office of Government Ethics found other issues:

A former business partner of Griles' hosted a party for Griles and top Interior officials for land and mining.

Also, a former Griles client, Advanced Power Technologies Inc., won some $2 million in no-bid contracts from his department after two people Griles supervised pressed APTI's case.

And Griles urged the EPA not to press concerns over a plan to open 8 million acres in Wyoming and Montana to gas drilling by companies including six of his former clients. The project is proceeding while a task force studies the matter.

The investigations of Griles found no illegalities. Secretary of the Interior Gale Norton announced that her right-hand man had been "cleared."

Review of ethics guidelines

Neither the Bush administration nor Congress has called for a systematic review of government's ethics guidelines.

They should, says Stuart Gilman, president of the Ethics Resource Center, a nonprofit group in Washington that works with companies and government groups.

"The question is, are we dealing with the problems we're currently confronting in government?" Gilman said.

Complaints about ethical breaches within government in some cases can be politically motivated, said Gilman, who also worked in the Office of Government Ethics under Presidents George H.W. Bush and Clinton.

At the same time, Gilman said, governmental leaders have a responsibility to eliminate both real and perceived conflicts of interest.

"For government to function, government must have the confidence of people," Gilman said. "If people don't believe the government is acting fairly, it encourages everyone to cheat."

Denver Post staff writers John Aloysius Farrell and Mike Soraghan and researchers Tamania Davis, Barbara Hudson and Regina Avila contributed to this report.

© Copyright 2004 The Denver Post


Within 100 high-level officials under President Bush now help govern industries they once represented as lobbyists, lawyers or company advocates, a Denver Post analysis shows. My department, here is a selection of some of the appointees, but their jobs are now, and what positions they held previously.


Samuel Wright Bodman, Deputy Secretary (left for treasury Post) background: chairman and CEO, Cabot chemicals and metals company.

Joseph Bogosian, deputy assistant secretary for transportation and machinery. Background: lobbyist for health care and energy companies. CSX freight transport Corp.

Donald L. Evans, Secretary. Background: CEO, Tom Brown energy company

Michael B. Gallagher, assistant secretary for communications and information and administrator of the National Telecommunications and Information Administration.

Kenneth I. Juster, undersecretary, bureau for industry and security. Background lawyer, Arnold and Porter, for international investments and arbitrations.

Bruce Mehlman, assistant secretary for technology policy (left office). Background: lobbyist for Cisco Systems Inc.

Nancy Victory, assistant secretary for communications and information (now at FCC). Background: lobbyist for personal communications industry.


Thomas F. Hall, assistant secretary for reserve affairs. Background: lobbyist Naval Research Association.

Gordon R. England, Navy secretary. Background: Executive Vice President, General Dynamics Corp.

Douglas J. Feith, undersecretary for policy. Background: lobbyist for Loral Spacecom, Northrop.

Powell Moore, assistant secretary for legislative affairs. Background: lobbyist Loral Corp. And communications.

Paul Michael Parker, assistant army secretary for Office of Civil Works (left office). Background: lobbyist, CSX freight transportation.

Richard Perle, chairman, Defense Policy Board (left office). Background: consultant, Global Crossing.

James Roche, Air Force secretary. Background: Vice President, Northrop Grumman defense company.

Marvin R. Sambur, assistant Air Force secretary for acquisition. Background: CEO of ITT defense.

Peter Teets, Air Force undersecretary for space-operations procurement. Background: president, Lockheed Martin


Marianne L. Horinko, assistant administrator for Office of Solid Waste in Emergency Response. Background: president, Clay Associates I'm a environmental policy consultants.


Kathleen Abernathy, commissioner. Background: lobbyist for AirTouch and US West.

Michael Powell, chairman. Background: telecommunications law with O'Melveny & Myers.


Sydney Taurel, member. Background: chairman, Eli Lilly.


David L. Bernhardt, director of congressional and legislative affairs. Background: lobbyist for Delta Petroleum Corp., Timid-Titanium Metals Corp.

Kit Kimball, director of intergovernmental and external affairs. Background: lobbyist, Western Regional Council for business interests.

Gail Norton, Secretary. Background: lobbyists, NL Industries chemical company.

Bennett William Raley, assistant secretary for water and science. Background: lobbyist with Trout and Raley in Denver representing water districts.

Patricia Lynn Scarlett, assistant secretary and chief financial officer. Background: president of Reason Foundation, funded by American Forest and Paper Association, the American Petroleum Institute, Chevron, Dow Chemical, others.


Thomas Sansonetti, assistant attorney general for environment and natural resources. Background: lobbyist national mining association and energy companies.


David Daniel Lauriski, assistant secretary, mine safety and health. Background: executive with East Mining Company.


Stephen Hatley, deputy national security adviser (now with Agency for International Development). Background: lawyer-lobbyist, represented Lockheed Martin.


Mitch Daniels, director (reside, running for Indiana Gov.). Background: senior vice president, Eli Lilly.


Harvey Pitt, chairman (left office). Background: lawyer at Fried, Frank, Harris, Shriver and Jacobson for accounting firms.


Jeffrey Shane, undersecretary for policy. Background: lawyer representing airline interests.

Read Van de Water, assistant secretary for aviation and international affairs (left for National Science Foundation). Background: lobbyist for Northwest Airlines, Business Roundtable.


Ann Veneman, Secretary. Background: lawyer-lobbyist for food companies


Anthony Principi, Secretary. Background: head of QTC Medical Services Inc., with VA contracts.


Doug Badger, senior health policy adviser and now deputy assistant trade representative. Background: lobbyist for pharmaceutical companies.

Randall Tobias, coordinator for international AIDS assistance. Background: chairman and CEO, Eli Lilly.

Cheney's Multi-Million Dollar Revolving Door

This makes fascinating reading:

News: As Bush Sr.'s secretary of defense, Dick Cheney steered millions of dollars in government business to a private military contractor -- whose parent company just happened to give him a high-paying job after he left the government.

By Robert Bryce
August 2, 2000

Ever since George W. Bush named him as a running mate, Dick Cheney has been all smiles. And why not? Cheney has led a charmed life. His political career included stints in the White House, Congress and the Defense Department. Then he went into the private sector and got rich.

But just how Cheney got rich deserves some scrutiny. As secretary of defense, Cheney oversaw one of the largest privatization efforts in the history of the Pentagon, steering millions of military dollars to civilian contractors. Two and a half years after Cheney left his federal job, he began cashing in on the very contracts that he helped initiate.

In 1992, the Pentagon, then under Cheney's direction, paid Texas-based Brown & Root Services $3.9 million to produce a classified report detailing how private companies -- like itself -- could help provide logistics for American troops in potential war zones around the world. BRS specializes in such work; from 1962 to 1972, for instance, the company worked in the former South Vietnam building roads, landing strips, harbors, and military bases. Later in 1992, the Pentagon gave the company an additional $5 million to update its report. That same year, BRS won a massive, five-year logistics contract from the US Army Corps of Engineers to work alongside American GIs in places like Zaire, Haiti, Somalia, Kosovo, the Balkans, and Saudi Arabia.

After Bill Clinton's election cost Cheney his government job, he wound up in 1995 as CEO of Halliburton Company, the Dallas-based oil services giant -- which just happens to own Brown & Root Services. Since then, Cheney has collected more than $10 million in salary and stock payments from the company. In addition, he is currently the company's largest individual shareholder, holding stock and options worth another $40 million. Those holdings have undoubtedly been made more valuable by the ever-more lucrative contracts BRS continues to score with the Pentagon.

Between 1992 and 1999, the Pentagon paid BRS more than $1.2 billion for its work in trouble spots around the globe. In May of 1999, the US Army Corps of Engineers re-enlisted the company's help in the Balkans, giving it a new five-year contract worth $731 million.

To critics, this all adds up to classic revolving-door politics: Cheney's work for Halliburton, they say, has allowed him to improperly profit off of actions he took and contacts he made while in government.

"Over the years, we've tried to slow the revolving door to make sure decision makers don't benefit from decisions they make while they are in office," said Tom Smith, the Texas state director of Public Citizen, a non-profit consumer group. "You have to question whose interests Cheney is looking after, and whether privatization has really benefited the Department of Defense, or the defense contractors like Brown & Root."

Although the US military has long relied on contractors for various services, the issue for some observers is the possibility that Cheney used his contacts within government to enrich himself. "We are talking about nepotism of the highest order and profiteering at the expense of the US taxpayers," says Pratap Chatterjee, a radio journalist who has followed Halliburton for several years.

Chatterjee points out that BRS gets a one percent profit guarantee on their logistics contracts and that in Somalia, the company was given another eight percentage points for meeting various incentive clauses in their contract. "Compare that with average corporate profit percentages, which are about three percent," he said.

Moreover, while there are advantages to using private companies to do soldiers' work, BRS has run into significant criticism for the way it has carried out some of its military missions.

The company has drawn praise for allowing more American soldiers to carry M-16's instead of spatulas. "It doesn't take a soldier to do what Brown & Root does for the Army," explains Jan Finegan, a spokesperson for the Army Materiel Command, who points out that the active-duty force of the US military has declined by about 25 percent over the past decade. Hiring a private contractor to take out the garbage, do the laundry and take care of the dining halls "frees soldiers up to do what they are trained to do," she said.

BRS also saves money by hiring local workers whenever possible. But that doesn't always turn out happily. In 1994, at the end of its engagement in Somalia, where American troops had attempted to quell endemic civil strife, BRS dismissed the Somali workers it had hired. The disenchanted workers then staged a protest at the United Nations compound in Mogadishu, until they were scattered by UN troops armed with batons and tear gas. Three people were reportedly injured in the melee.

In 1996, in Hungary, where BRS had set up shop to support American troops stationed in the former Yugoslavia, the company ran into more controversy. Shortly after American forces moved in, Hungarian officials ruled that BRS was subject to the country's value-added tax, and that company employees were subject to Hungarian income tax, just like any other private corporation. The Pentagon, however, insisted that the company was part of the American military and therefore exempt from the tax. Ultimately, BRS did pay the Hungarian government $18 million in taxes -- for which it was reimbursed by the US government. The company was also accused of sexual harassment by several female workers who claimed that BRS employees had fondled and propositioned them.

Nonetheless, BRS, which has 20,000 employees worldwide, continues to pull in major government deals. The company recently won a $100 million contract from the US State Department to upgrade security at its embassies. It also holds a long-term contract with the British military to operate the Devonport Royal Naval Dockyard, the UK's sole refitting and refueling location for nuclear powered submarines.

Nine years ago, Dick Cheney was overseeing the military's performance in the Gulf War. Since then, he has made millions running a business that provides services to that same military. That business, incidentally, has contributed a quarter-million dollars to the Republican cause so far this election cycle. And now, Cheney and Bush are the odds-on favorites to take the White House.

Is this politics as usual? Or is it business as usual? In Cheney's case, it's difficult to tell the difference.