Administration Moves to Avert a Late Rules Rush

Hmm .. does this administration really believe it will make it to the end of its term?

Veeger

By CHARLIE SAVAGE and ROBERT PEAR

Published: May 31, 2008

WASHINGTON — The Bush administration has told federal agencies that they have until June 1 to propose any new regulations, a move intended to avoid the rush of rules issued by previous administrations on their way out the door.

May 31, 2008

Regulations in the Pipeline

Related

White House Memo From Joshua B. Bolten (pdf)

The White House has also declared that it will generally not allow agencies to issue any final regulations after Nov. 1, nearly three months before President Bush relinquishes power.

While the White House called the deadlines “simply good government,” some legal specialists said the policy would ensure that rules the administration wanted to be part of Mr. Bush’s legacy would be less subject to being overturned by his successor. Moreover, they said, the deadlines could allow the administration to avoid thorny proposals that are likely to come up in the next few months, including environmental and safety rules that have been in the regulatory pipeline for years.

Many regulations do not take effect until 60 days after they have been issued, and a new president can try to postpone or revise them. After Mr. Bush took office in 2001, for example, he froze hundreds of pending regulations issued by the administration of Bill Clinton.

Mr. Clinton, in turn, had imposed a similar moratorium on last-minute regulations issued by the first President Bush.

Many officials in government agencies said they were caught unaware by the White House’s order, issued May 9.

Some officials described a flurry of activity as they sought to get proposals approved for publication in the Federal Register by June 1.

“There are good-government reasons to do what they are doing,” said Sally Katzen, the top regulatory aide to Mr. Clinton from 1993 to 1998. “But it has the added advantage of providing an excuse for not doing something they don’t want attributed to them, and for speeding up the things they want to lock in before the next administration.”

The highly unusual directive was outlined in a memorandum that Joshua B. Bolten, the White House chief of staff, issued to agency heads without public announcement.

The government should “resist the historical tendency of administrations to increase regulatory activity in their final months,” Mr. Bolten wrote. “We must recognize that the burden imposed by new regulations is cumulative and has a significant effect on all Americans.”

Mr. Bolten told agencies that the administration would make exceptions for rules that missed the deadline in “extraordinary circumstances,” which he did not define.

Still, the June 1 deadline to start the public comment process places at risk of delay scores of potential regulations, including protections for the environment and rules on workplace safety and public health.

Agency officials said it was impossible to speed up many proposals, some of which run for hundreds of pages, with three weeks’ notice. One official said his agency was resigned to the fact that some of its work would be delayed until the next administration, while another said he was hoping that the White House would exempt some proposals that missed the June 1 deadline but that were in line with the administration’s agenda.

Rick Melberth, the director of regulatory policy for OMB Watch, a nonpartisan government watchdog group, predicted that the administration, in keeping with its longstanding skepticism about regulation, would make it a priority to complete rules that relax regulations on industrial pollution and other burdens on business.

Mr. Melberth also predicted that the administration would be willing to invoke the exception for “extraordinary circumstances” to allow rules that give businesses more flexibility than Mr. Bush’s successor might, especially if the next president is a Democrat.

“They get to define emergency,” Mr. Melberth said.

“On other things, they could do ‘Sorry, we can’t do anything on this’ ” because of the deadline, he added.

But the White House defended the order as a way to ensure that there will be adequate time for a careful and transparent review of any new regulations.

“We’re not shutting down work on important regulatory matters after June 1st,” a White House spokeswoman, Emily Lawrimore, said in an e-mail message. “We’re just making clear that we will continue to embrace the thorough and high standards of the regulatory review process as we near the end of the administration.”

Mr. Bolten’s order will affect only potential rules controlled by the Bush administration. It does not apply to independent agencies or to pending regulations with deadlines imposed by federal statutes or court orders. The memorandum also does not prevent agencies from continuing work on potential rules that are not intended to be made final until after the next president takes office.

Still, the order places at risk of delay a host of pending regulations across the federal government that agencies have not yet formally proposed, including some backed by business interests.

The construction industry, for example, has been waiting for years for the Labor Department to issue updated safeguards to prevent crane accidents like the one in New York City on Friday. Industry and labor negotiators agreed to standards in 2004, but the administration has yet to issue them. Robert Weiss, the vice president of Cranes Inc., a provider of cranes in New York and a member of the negotiating committee that reached the agreement, said that the rule “could save many lives” but that he did not know how the White House memorandum might affect its prospects.

And Jeffrey Barach, vice president of the Grocery Manufacturers Association, said he feared that the deadline could jeopardize some rules that food manufacturers want. For example, the food industry has been pressing for more stringent requirements on farms to lower the risk that the food supply might be contaminated by crops that have been genetically modified to produce pharmaceuticals. The Department of Agriculture is planning to issue such a proposed rule in June, too late for the deadline.

“If it doesn’t go through now, it will be delayed,” Mr. Barach said. “There is already, out in the field, developmental work on pharmaceutical crops, which is expected to increase. So any delay is of concern to us.”

Still, the administration’s efforts won praise from William L. Kovacs, a vice president of the United States Chamber of Commerce, who said the memorandum was a “reasonable, sensible” effort to avoid so-called midnight rules.

“This is a gracious way of leaving office,” Mr. Kovacs said. “The White House is saying, ‘We will control the regulatory process so the next administration won’t end up with a lot of regulations being challenged in court in its first days in office.’ ”

But John D. Walke, director of the clean air program at the Natural Resources Defense Council, denounced Mr. Bolten’s memorandum as intending to

“shut down regulation for the remainder of the Bush administration.”

“Until the bitter end,”

Mr. Walke said,

“the administration will pursue deregulation on behalf of polluting industries and avoid regulation that would protect public health, welfare and the environment. This memo is a codification of that agenda.”

Still, some public-interest groups expressed ambivalence about the early deadlines. Several said they welcomed further delays in some long-sought regulations because they believed the next president, Republican or Democrat, might issue rules more favorable to their policy preferences.

Books of Note: Bodies Gone Haywire in a World out of Balance

The Autoimmune Epidemic: Bodies Gone Haywire in a World out of Balance

By Donna Jackson Nakazawa, Touchstone/Simon & Schuster
Posted on March 19, 2008, Printed on March 19, 2008

http://www.alternet.org/story/80129/

Excerpted from The Autoimmune Epidemic: Bodies Gone Haywire in a World Out of Balance--and the Cutting-Edge Science that Promises Hope

(Touchstone/Simon & Schuster).
Reprinted with permission. An interview with the author follows.

Most of us, at some juncture in our lives, have played out in our minds how devastating it would be to have our doctor hand down a cancer diagnosis or to warn us that we are at risk for a heart attack or stroke. Magazine articles, television dramas, and news headlines all bring such images home.

But consider an equally devastating health crisis scenario, one that you rarely hear spoken about openly, one that receives almost no media attention.

Imagine the slow, creeping escalation of seemingly amorphous symptoms: a tingling in the arms and fingers, the sudden appearance of a speckled rash across the face, the strange muscle weakness in the legs when climbing stairs, the fiery joints that emerge out of nowhere -- any and all of which can signal the onset of a wide range of life-altering and often debilitating autoimmune diseases.

Imagine, if you can: the tingling foot and ankle that turns out to be the beginning of the slow paralysis of multiple sclerosis. Four hundred thousand patients. Excruciating joint pain and inflammation, skin rashes, and never-ending flu-like symptoms that lead to the diagnosis of lupus. One and a half million more. Relentless bouts of vertigo -- the hallmark of Ménière's. Seven out of every one thousand Americans. Severe abdominal pain, bleeding rectal fissures, uncontrollable diarrhea, and chronic intestinal inflammation that define Crohn's disease and inflammatory bowel disease. More than 1 million Americans. More than 2 million patients. Dry mouth so persistent eight glasses of water a day won't soothe the parched throat and tongue and the mysterious swallowing difficulties that are the first signs of Sjögren's. Four million Americans. And, with almost every autoimmune disease, intolerable, life-altering bouts of exhaustion. If fatigue were a sound made manifest by the 23.5 million people with autoimmune disease in America, the roar across this country would be more deafening than that of the return of the seventeen-year locusts.

And yet, despite the prevalence of autoimmune disease, surveys show that more than 90 percent of people cannot summon the name of a single autoimmune disease when asked to name one specifically.

Think of it -- other than walkathons for multiple sclerosis, how many fundraising walks or lapel ribbons have you seen for autoimmune disease in general? Nearly 24 million Americans are suffering from an autoimmune illness, yet nine out of ten Americans cannot name a single one of these diseases. It boggles the mind.

Each of these nearly 100 autoimmune diseases derails lives. Taken collectively, these diseases, which also include type 1 diabetes, Graves' disease, vasculitis, myasthenia gravis, connective tissue diseases, autoimmune Addison's disease, vitiligo, rheumatoid arthritis, hemolytic anemia, celiac disease, and scleroderma are now the Number Two cause of chronic illness in America and the third leading cause of Social Security disability behind heart disease and cancer. (Acquired immune deficiency syndrome, or AIDS, by contrast, is not an autoimmune disease; in fact, it is entirely different. In AIDS a virus attacks the immune system and destroys it, whereas in autoimmune disease, the immune system leads the attack, mistaking the body's tissue for an invader and turning on the body itself.)

Autoimmune diseases are the eighth leading cause of death among women, shortening the average patient's lifespan by fifteen years. Not surprisingly, the economic burden is staggering: autoimmune diseases represent a yearly health-care burden of more than $120 billion, compared to the yearly health-care burden of $70 billion for direct medical costs for cancer.
To underscore these numbers, consider: while 2.2 million women are living with breast cancer and 7.2 million women have coronary disease, an estimated 9.8 million women are afflicted with one of the seven more common autoimmune diseases: lupus, scleroderma, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, Sjögren's, and type 1 diabetes. All of these can lead to potentially fatal complications.

Or slice these statistics another way: while one in 69 women below the age of fifty will be diagnosed with breast cancer, according to estimates, as many as one in nine women of childbearing years will be diagnosed with an autoimmune illness, which strike three times as many women as men -- and most often strike patients in their prime. According to the National Institutes of Health, autoimmune disease affects far more patients than the 9 million Americans who have cancer and the 16 million with coronary disease.

"The Western Disease": A Rising Epidemic Underrecognized and Underaddressed

Even as autoimmune diseases remain underrecognized and underaddressed, the number of patients afflicted with these illnesses has been steadily growing. Yet few of today's practicing physicians are aware of the escalating tsunami of epidemiological evidence that now concerns top scientists at every major research institute around the world: evidence that autoimmune diseases such as lupus, MS, scleroderma, and many others are on the rise and have been for the past four decades in industrialized countries around the world.

Mayo Clinic researchers report that the incidence of lupus has nearly tripled in the United States over the past four decades. Their findings are all the more alarming when you consider that their research has been conducted among a primarily white population at a time when many researchers believe lupus rates are rising most significantly among African Americans.

Over the past fifty years multiple sclerosis rates have tripled in Finland. Rates have likewise been rising in Scotland, England, the Netherlands, Denmark, and Sweden, where the number of people with MS has been rising at nearly 3 percent a year. Multiple sclerosis rates in Norway have risen 30 percent since 1963, echoing trends in Germany, Italy, and Greece, where MS rates have doubled over the past thirty to forty years.

Rates of type 1 diabetes are perhaps the most telling. Data over the past forty years show that type 1 diabetes, a disease in which immune cells attack the insulin-producing beta cells in the pancreas, has increased fivefold. The story regarding childhood-onset type 1 diabetes is more disturbing. Studies show that the number of children with type 1 diabetes is skyrocketing, with rates increasing 6 percent a year in children four and under and 4 percent in children aged 10 to 14.

Rates of numerous other autoimmune diseases -- scleroderma, Crohn's disease, autoimmune Addison's disease, and polymyositis -- show the same alarming pattern.

As with all epidemiological research, it can be more art than science to tease out what percentage of these rising rates is the result of more people being diagnosed with a disease because physicians are more aware of it, versus the increase from a genuine rise in the number of people falling ill. Yet the researchers behind these epidemiological studies hold that something more than an improved ability among doctors to diagnose autoimmune diseases is driving these numbers upward.

Norwegian epidemiologists, for instance, argue that rising rates are "due to a real biological change of the disease" rather than being caused solely by better diagnostics and are concerned by the higher occurrence of autoimmunity in urban than in rural areas. Swedish and German researchers concur that enhanced diagnostics alone cannot explain today's significant increases in MS.

Type 1 diabetes researchers insist that today's rapid rise in this disease cannot be explained by either better diagnostics or by more people suddenly becoming genetically susceptible to type 1 diabetes; rather, a change in environmental factors is the "more plausible explanation." At the Mayo Clinic researchers are beginning to ask if rising rates of lupus are the result of an increased exposure to environmental triggers of some unknown origin. Because autoimmune disease is spreading in almost every industrialized nation, scientists the world over have dubbed it "the Western disease."

A Growing Autoimmune Patient Load, An Autoimmune-Disease Crisis in the Making

While epidemiological studies provide a global portrait of an autoimmune-disease crisis in the making, it is through patients' eyes that it takes on more personal meaning. And nowhere is this more evident than at the offices of Dr. Michelle Petri, clinical director of the Johns Hopkins Lupus Center, at the Johns Hopkins Outpatient Center in downtown Baltimore, Maryland. Dr. Petri is a heavy hitter in the field of rheumatology and a nationally known speaker on lupus. Many of the people she treats have waited months for an appointment in order to confirm a diagnosis or gain better treatment for such rheumatic autoimmune diseases as lupus and antiphospholipid syndrome. Some of them are local residents who live merely a few blocks away from her office, while other patients fly thousands of miles to see her.

Over the course of her thirty-year career, Petri has witnessed a dramatic rise in patients with lupus. In the 1960s there were only 150 to 200 lupus patients registered in the Hopkins Rheumatology Clinics. Today, there are 1,700 lupus patients registered from the immediate neighborhood alone. "The population in Baltimore is going down, and yet the number of people coming to our clinic from Baltimore with autoimmune disease is going up," she says.

In an administrative building nearby sits the lupus clinic records room. In the twenty-by-twenty-foot space loom four walls of filing cabinets -- enough to easily fill up the four walls in your local 7-Eleven -- packed with patient files that, twenty years ago, would have fit neatly into a few metal drawers. Although Petri has no way of conducting formal epidemiologic research through her clinic, the continued rise in the percent of patients afflicted in her own small urban area is, she says, a "very disturbing" sign.

Certainly, some of the increase that Petri and other clinicians are seeing in lupus is due to the improved treatment many patients receive through kidney dialysis and transplants, which help them live longer (the longer patients survive, the larger the overall patient number). And the skill with which physicians diagnose lupus has improved somewhat in many large metropolitan hospital centers. However, this increase in lupus "is so enormous," says Petri, part of it can only be explained by an increase in the incidence of lupus itself.

Petri's emphatic tone reveals her concern for her patients' well-being as well as her frustration over how little physicians understand about why so many people's immune systems are attacking their own healthy tissue. The fact that so many front-line practitioners are ill trained in how to diagnose these diseases can result in patients facing costly delays -- both physically and emotionally -- in getting the help they need.

One of these patients was Kathleen Arntsen, a 44-year-old sales professional from Verona, New York. After five years of searching for a diagnosis for what would turn out later to be myasthenia gravis, a disease in which sufferers develop severe muscle fatigue and disabling weakness, Kathleen was told by a doctor she'd been to eight times, "We've given you every test known to man except for an autopsy. Would you like one of those too?" For half a decade, she says, "I was treated like an absolute fruitcake. No one could tell me what was wrong with me, much less treat me."

Arntsen's story is not unusual. The average patient with autoimmune disease sees six doctors before attaining a correct diagnosis. Recent surveys conducted by the American Autoimmune Related Diseases Association reveal that 45 percent of patients with autoimmune diseases have been labeled hypochondriacs in the earliest stages of their illnesses. Some of this, no doubt, has to do with the fact that 75 percent to 80 percent of autoimmune disease sufferers are women, who are more easily dismissed by the medical establishment when hard-to-diagnose symptoms arise. In half of all cases, women with autoimmune disease are told there is nothing wrong with them for an average of five years before receiving diagnosis and treatment. Patients -- most especially women -- are often left feeling both confused and marginalized, or worse, labeled as psychosomatic malingerers.

Arntsen was fortunate to find her way eventually to Johns Hopkins University's neuromuscular clinic and later to Michelle Petri for confirmation, consultation, and validation regarding her polyautoimmune disorders, which include lupus, Sjögrens, Graves' thyroid disease, APS, psoriasis, Raynaud's disease, and myasthenia gravis. Yet despite having an accurate set of diagnoses, Arntsen's autoimmune illnesses have forced her to give up almost everything she once equated with normal life in order to preserve the stamina to get through each day. Once a healthy young woman on a full scholarship to Colgate University, where she was captain of the women's rugby team, Arntsen now has to stop and pick up each knee as she goes up the stairs. "I coexist," she says, "with bone-gnawing pain." For years, her long flame of red hair, which once reached her tailbone, turned scarce and thin, the fallout of her autoimmune thyroiditis, coupled with drug side effects. In the past decade she has spent almost a year and a half in the hospital during her most severe lupus flares. Although she is carefully monitored, there is little the medical establishment can offer Kathleen for her lupus and myasthenia gravis other than steroids, a healthy diet, and boatloads of rest -- especially since no new U.S. Food and Drug Administration-approved drugs have been developed for lupus in more than forty years.

Kathleen's debility and exhaustion, which have taken a permanent toll on her life and career, will never go away. A top-performing sales rep for an insurance company while in her thirties, Arntsen, who used to run three miles a day, now lives on Social Security disability -- which, she says ruefully, allows time for "my new full-time job -- seeing specialists." She gets going each day by around noon and spends what stamina she has left volunteering at the Lupus Foundation of Mid and Northern New York, which has become her "baby," although it can hardly begin to make up for the fact that "the chance to be a mother has been stolen from me." The best Kathleen and her husband of fifteen years can hope for is that with the careful monitoring of diet, stress, and sleep, she will have more good days than bad.

To look at Kathleen, however, you would never guess what she has been through or what she faces each morning at the start of her day. Like many people who suffer from autoimmune diseases, Kathleen's symptoms remain largely invisible. "Because we go through ups and downs, you might see us on a good day, between severe flares, when we seem to be perfectly fine," she says. "You don't know that we've just spent six weeks in hell." Few can imagine, she adds, that behind her bedroom door even on one of these good days, Kathleen has to take twenty-two medications about an hour before she tries to get up, just so she can handle the pain when her feet hit the floor. "By the time you run into me at the grocery store at two o'clock in the afternoon and say hello to me, I'm ready to nod and say, 'Oh, I'm fine, how are you?'"

© 2008 Donna Jackson Nakazawa.
*****
Q&A with Donna Jackson Nakazawa, author of The Autoimmune Epidemic: Bodies Gone Haywire in a World out of Balance -- and the Cutting Edge Science that Promises Hope (Touchstone/Simon & Schuster, February 2008).

Q. In your book you say that the number of people suffering from autoimmune diseases such as lupus, multiple sclerosis and type 1 diabetes has skyrocketed -- more than doubling in the last three decades. Yet we hear very little about this epidemic. Why?

Nakazawa: Lupus, multiple sclerosis, type 1 diabetes and rheumatoid arthritis are just a few of the more common types of autoimmune disease, but in fact there are nearly a hundred other known autoimmune diseases. One in 12 people -- and one in 9 women -- has an autoimmune disease. That's nearly 24 million Americans. Yet even though autoimmune diseases afflict more than double the number of people who have cancer, and a woman is 8 times more likely to have an autoimmune disease than breast cancer, 90 percent of Americans say they can't name a single autoimmune disease. That's because people just don't know that many painful and life-altering disorders that increasingly afflict so many of their friends and family members today are autoimmune in nature; the body's immune system, which is meant to protect us, is mistakenly attacking the body's own organs and systems.

We also don't hear much about these diseases because the exact process by which our immune system turns from friend to foe was, for many decades, the black box of modern science. Until the late 1970s scientists didn't even agree that the body could turn on itself, much less why. It's only in the last ten years that scientists have been able to show in the lab exactly how the immune system, when it's overwhelmed by foreign invaders such as chemicals and viruses, can go haywire and destroy our own tissue and organs in acts we might think of as "friendly fire." The fact that these diseases have been difficult for the medical community to understand means that even today getting a correct diagnosis can be very difficult. Most people who have an autoimmune disease see six doctors over four years before they get a diagnosis. One patient suffering from severe muscle fatigue and disabling weakness was told by a doctor she'd seen eight times: "We've given you every test known to man except for an autopsy. Would you like one of those too?" It was five years before she got a diagnosis of myasthenia gravis. The medical establishment often lacks a full understanding as to how to diagnose these diseases, dismisses women who complain of symptoms, and often has little to offer in the way of effective treatment. So one reason autoimmune diseases are not on our radar screens is that these diseases were, for many decades, mysterious and not well understood.

Another reason, I suspect, is that on some level we don't want to face the facts. Rates of these diseases have doubled and tripled in industrialized countries around the world over the past three decades. The top scientists I interviewed for my book agree that something in our environment -- something far beyond a better ability to diagnose these diseases -- is causing this health crisis. They are convinced that the cause of this epidemic -- which is world-wide, by the way -- lies primarily in our environment and in all the toxins, pesticides, heavy metals and chemicals that have become a part of our everyday living. We all carry a "body burden" of toxins in our bloodstream, even babies. Several studies show that chemicals commonly used in household cleaners, cosmetics and furniture are present in infant fetal cord blood. This doesn't sound healthy, does it? But even if we agree that this soup of chemicals within us is harmful, what do we do about it? Talking about the autoimmune epidemic is a bit like talking about global warming before the movie An Inconvenient Truth was released. For the longest time, we couldn't see, or didn't want to see, that the smallest rise in temperature would melt the polar ice caps. Likewise, we don't want to know that the ways we're polluting our environment are also harming our bodies and our immune cells. In the international medical world, the scientists who study autoimmune disease call this epidemic "the global warming of women's health." Yet the reality that the environment plays a major role in triggering these diseases hasn't yet trickled down to the rest of the population. {Bad comparison!! Actually, Al Gore's theories are the example of a thought virus .... }

Q. You coin the term "autogen" to describe the agents that trigger autoimmune disease. What are some examples of autogens?

Nakazawa: There are thousands of probable autogens we have not yet studied. Eighty thousand chemicals have been approved for use in our environment. Every year 1700 new chemicals are approved -- that's an average of five a day. Have scientists studied the effects on our bodies of all these chemicals? No. However, those chemicals that have been researched -- in occupational studies and in studies of lab animals -- have been shown to play a role in triggering autoimmune reactions. For example, mice exposed to pesticides -- at levels four-fold lower than the level set as acceptable for humans by the EPA -- are more susceptible to getting lupus than control mice. Mice that absorb low doses of trichloroethylene (TCE) -- a chemical used in industrial degreasers, dry-cleaning, household paint thinners, glues and adhesives -- at levels deemed safe by the EPA, and equal to what a factory worker today might encounter, quickly develop autoimmune hepatitis. And low doses of perfluorooctanoic acid, a breakdown chemical of Teflon that can be found in 96 percent of humans tested for it, impair the development of a proper immune system in rats.

We know from occupational studies in humans that these chemicals impair our immune systems in dangerous ways. In 2007, scientists from the National Institutes of Health announced -- after studying 300,000 death certificates in 26 states over a 14-year period -- that those who worked with pesticides, textiles, hand painting, solvents (such as TCE), benzene, asbestos, and other compounds were significantly more likely to die from an autoimmune disease than people who were not exposed. Other recent studies show links between working with solvents, silica dust, asbestos, PCBs and vinyl chloride and a greater likelihood of developing autoimmune disease.

Q. But not everyone who is exposed to these autogens comes down with a disease. So, why do some people get an autoimmune disease and not others?

Nakazawa: That's because of a phenomenon I call the "barrel effect." Each person, with his or her unique genetic composition, is exposed to a myriad combination and level of autogens depending on what they encounter in their day-to-day lives through the air they breathe and what they come into contact with through their skin. This toxic stew consists not only of chemicals and heavy metals, but additives in our highly processed diet and viruses and bacterial agents to which we're exposed -- all of which combine to impact our immune system. Chronic stress, which releases cortisol into our body, also plays a role in triggering these diseases as do women's reproductive hormones -- which is why women are three times more likely than men to come down with an autoimmune disease. As long as your barrel is less than full, however, your immune system is still able to deal with what it confronts every day. But once the immune system becomes overburdened it can begin to send misread signals, causing the immune system to make costly mistakes and attack the body itself. Unfortunately in modern life we've created a perfect storm of factors -- a plethora of chemicals, heavy metals, processed food additives, viral hits and stressors -- for today's autoimmune epidemic to take hold. So much of what we encounter in twenty-first century life is causing our barrel to fill to the brim -- and spill over. At that point, disease strikes.


Q. Is it only people with a genetic predisposition who are vulnerable to this "barrel effect"?

Nakazawa: No. Researchers have found that anyone can be susceptible. Whether or not you get an autoimmune disease depends on how many of these triggers you've been exposed to over your lifetime -- or how full your barrel is. People with a genetic predisposition -for example, if you have a close relative who has an autoimmune disease, you may be genetically inclined that way -- may be more vulnerable, but anyone whose immune system is overtaxed or over-stimulated can get sick.

Q. You talk about "clusters" of autoimmune diseases in your book. For example, in Buffalo, NY, in a small neighborhood surrounding known toxic waste sites, an unusually high number of people have developed lupus. And yet, the U.S. Department of Environmental Conservation is doubtful that there's a link. Why is that?

Nakazawa: Clusters are hugely controversial in part because our scientific criteria for proving that exposure A caused disease B in a community are extremely difficult to meet. Autoimmune diseases take years to appear after exposure, and communities are often constantly changing. People move, or die, or their disease is never properly diagnosed. How can we prove, with all these variables, that a toxic exposure in an area caused a group of people to fall ill with a specific set of diseases? Moreover, so much toxic waste exists everywhere, how can we definitively compare what autoimmune disease rates might be in a non-chemically laden area with those in a highly contaminated area when such clear-cut lines rarely exist in the cities and suburbs where we live? So it's very difficult.

Nevertheless, autoimmune clusters have been shown to exist near toxic waste sites in Buffalo, New York; El Paso, Texas; and Morrison, Illinois and its environs. Many more are being investigated, including in Anniston, Alabama, where investigators funded by the Agency for Toxic Substances and Disease Registry are conducting studies to determine whether high rates of autoimmune disease in the area are linked to an industrial manufacturing site where most of the PCBs in the United States were once manufactured and dumped. From Anniston to Buffalo we live in an increasingly complex sea of autogenic agents.

Still, we say we can't "prove" that chemicals are impairing the human immune system. Meanwhile, European environmental policy uses the precautionary principle -- an approach to public health that underscores preventing harm to human health before it happens. In June 2007, the European Union implemented legislation known as REACH (the Registration, Evaluation, Authorization and Restriction of Chemical Substances), which requires companies to develop safety data on 30,000 chemicals over the next decade, and places responsibility on the chemical industry to demonstrate the safety of their products. America lags far behind, without any precautionary guidelines regarding chemical use.

Obviously, political and economic considerations come into play here. There are over 1200 "superfund" sites around the U.S. -areas where deadly toxins are known to be seeping into the environment -- and these have yet to be cleaned up. At about 10 percent of these sites, people are freely entering the area and being exposed directly to the hazardous waste. Unfortunately, the Environmental Protection Agency does not release information about how much it plans to spend to remediate these sites, when the area will be cleaned up or how long it will take.

Q. You were twice paralyzed with the autoimmune disease Guillan Barre Syndrome during the writing of this book. How did you recover?

Nakazawa: Most patients with an autoimmune disease go through terribly difficult times -- or flare-ups -- which can be quite serious. Getting through a downturn involves a combination of factors. If you know what can contribute to disease it's easier to know how you can help yourself. Months of grueling physical therapy, coupled with IVIG treatments, helped me recover each time I was paralyzed. I also have had to be vigilant about what goes into my body and avoid coming into contact with things that might overstimulate my immune system. Dietary factors, use of household cleaners, emotional stress -- these all have to be watched and managed. Also, we do a lot of hand washing in my home, especially when there are colds and flu going around, to minimize any viral hits to my immune system. Studies show that patients with an autoimmune disease also do better if they build a wellness plan that involves reducing stress hormones through a daily habit of meditation and whatever form of exercise they can tolerate. Studies show that autoimmune patients also do much better if they follow "the autoimmune diet," which means consuming foods that are anti-inflammatory. For example, most autoimmune specialists agree that patients should avoid wheat and gluten products and highly processed foods, which can be inflammatory or provoke the immune system to overreact. So one needs to work with a doctor who is open to treating you not just with drugs but also with dietary changes, including making sure you're receiving adequate amounts of the main supplements that have been shown in clinical studies to help autoimmune disease patients, such as omega fatty acids, Vitamin D, antioxidants, probiotics, and glucosamine.

More! Ever more! on GM foods!

Don't ever say I didn't warn you!!

This is HIGHLY relevant as the Competitiveness Council appears to be applauding itself over this issue at the annual meeting coming in November. Aren't they just so damned clever??

How Corporations Engineered the Non-Regulation of Dangerous Genetically Modified Foods

• An FDA-Created Health Crisis Circles the Globe
  By Jeffrey Smith
  October 11,2007
  Straight to the Source
  
  

Government officials around the globe have been coerced, infiltrated, and paid off by the agricultural biotech giants. In Indonesia, Monsanto gave bribes and questionable payments to at least 140 officials, attempting to get their genetically modified (GM) cotton approved.[1] On the basis of this manufactured and false notion of no meaningful differences, the FDA does not require GM food safety testing.

To further justify their lack of oversight, they claimed that GM crops were "substantially equivalent" to their natural counterparts. But this concept does not hold up to scrutiny. The Royal Society of Canada described substantial equivalence as "scientifically unjustifiable and inconsistent with precautionary regulation of the technology." In sharp contrast to the FDA's position, the Royal Society of Canada said that "the default prediction" for GM crops would include "a range of collateral changes in expression of other genes, changes in the pattern of proteins produced and/or changes in metabolic activities."[11]

Fake safety assessments Biotech companies do participate in a voluntary consultation process with the FDA, but it is derided by critics as a meaningless exercise. Companies can submit whatever information they choose, and the FDA does not conduct or commission any studies of their own. Former EPA scientist Doug Gurian-Sherman, who analyzed FDA review records obtained through the Freedom of Information Act, states flatly,

"It is clear that FDA's current voluntary notification process (even if made mandatory) is not up to the task of ensuring the safety of future GE [genetically engineered] crops." He says, "The FDA consultation process does not allow the agency to require submission of data, misses obvious errors in company-submitted data summaries, provides insufficient testing guidance, and does not require sufficiently detailed data to enable the FDA to assure that GE crops are safe to eat."[12]

Similarly, a Friends of the Earth review of company and FDA documents concluded:

"If industry chooses to submit faulty, unpublishable studies, it does so without consequence. If it should respond to an agency request with deficient data, it does so without reprimand or follow-up. . . . If a company finds it disadvantageous to characterize its product, then its properties remain uncertain or unknown. If a corporation chooses to ignore scientifically sound testing standards . . . then faulty tests are conducted instead, and the results are considered legitimate. In the area of genetically engineered food regulation, the 'competent' agencies rarely if ever (know how to) conduct independent research to verify or supplement industry findings."[13]

At the end of the consultation, the FDA doesn't actually approve the crops. Rather, they issue a letter including a statement such as the following:

"Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different in composition, safety, and other relevant parameters from corn currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA. . . . As you are aware, it is Monsanto's responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements."[14]

The National Academy of Sciences and even the pro-GM Royal Society of London[15] describe the US system as inadequate and flawed. The editor of the prestigious journal Lancet said,

"It is astounding that the US Food and Drug Administration has not changed their stance on genetically modified food adopted in 1992. . . . The policy is that genetically modified crops will receive the same consideration for potential health risks as any other new crop plant. This stance is taken despite good reasons to believe that specific risks may exist. . . . Governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health."[16]

Promoting and regulating don't mix The FDA and other regulatory agencies are officially charged with both regulating biotech products and promoting them-a clear conflict. Suzanne Wuerthele, a US EPA toxicologist, says,

"This technology is being promoted, in the face of concerns by respectable scientists and in the face of data to the contrary, by the very agencies which are supposed to be protecting human health and the environment. The bottom line in my view is that we are confronted with the most powerful technology the world has ever known, and it is being rapidly deployed with almost no thought whatsoever to its consequences."

Canadian regulators are similarly conflicted. The Royal Society of Canada reported that,

"In meetings with senior managers from the various Canadian regulatory departments . . . their responses uniformly stressed the importance of maintaining a favorable climate for the biotechnology industry to develop new products and submit them for approval on the Canadian market. . . . The conflict of interest involved in both promoting and regulating an industry or technology . . . is also a factor in the issue of maintaining the transparency, and therefore the scientific integrity, of the regulatory process. In effect, the public interest in a regulatory system that is 'science based'-that meets scientific standards of objectivity, a major aspect of which is full openness to scientific peer review-is significantly compromised when that openness is negotiated away by regulators in exchange for cordial and supportive relationships with the industries being regulated."[17]

The conflict of interest among scientists at the European Food Safety Authority (EFSA) GMO Panel is quite explicit. According to Friends of the Earth,

"One member has direct financial links with the biotech industry and others have indirect links, such as close involvement with major conferences organized by the biotech industry. Two members have even appeared in promotional videos produced by the biotech industry. . . . Several members of the Panel, including the chair Professor Kuiper, have been involved with the EU-funded ENTRANSFOOD project. The aim of this project was to agree [to] safety assessment, risk management and risk communication procedures that would 'facilitate market introduction of GMOs in Europe, and therefore bring the European industry in a competitive position.' Professor Kuiper, who coordinated the ENTRANSFOOD project, sat on a working group that also included staff from Monsanto, Bayer CropScience and Syngenta."

The report concludes that EFSA is

"being used to create a false impression of scientific agreement when the real situation is one of intense and continuing debate and uncertainty."[18]

This parallels the deceptive façade at the FDA. The pro-GM European Commission repeats the same ruse. According to leaked documents obtained by Friends of the Earth, while they privately appreciate

"the uncertainties and gaps in knowledge that exist in relation to the safety of GM crops . . . the Commission normally keeps this uncertainty concealed from the public whilst presenting its decisions about the safety of GM crops and foods as being certain and scientifically based."

Further, in private

"they frequently criticize the European Food Safety Authority (EFSA) and its assessments of the safety of GM foods and crops, even though the Commission relies on these evaluations to make recommendations to member states. . . [and] to justify its decisions to approve new GM foods."[19]

For example, the Commission privately condemned the submission information for one crop as "mixed, scarce, delivered consecutively all over years, and not convincing."

They said there is "No sufficient experimental evidence to assess the safety."[20]

Evaluations miss most health problems Although the body of safety studies on GM foods is quite small, it has verified the concerns expressed by FDA scientists and others. The gene inserted into plant DNA may produce a protein that is inherently unhealthy. The inserted gene has been found to transfer into human gut bacteria and may even end up in human cellular DNA, where it might produce its protein over the long-term. Toxic substances in GM animal feed might bioaccumulate into milk and meat products. Farmer and medical reports link GM feed to thousands of sick, sterile, and dead animals. But there is not a single government safety assessment program in the world that is competent to even identify most of these potential health problems, let alone protect its citizens from the effects.[21]

A review of approved GM crops in Canada by professor E. Ann Clark, for example, reveals that 70% (28 of 40) "of the currently available GM crops . . . have not been subjected to any actual lab or animal toxicity testing, either as refined oils for direct human consumption or indirectly as feedstuffs for livestock. The same finding pertains to all three GM tomato Decisions, the only GM flax, and to five GM corn crops." In the remaining 30% (12) of the other crops tested, animals were not fed the whole GM feed. They were given just the isolated GM protein that the plant was engineered to produce. But even this protein was not extracted from the actual GM plant. Rather, it was manufactured in genetically engineered bacteria. This method of testing would never identify problems associated with collateral damage to GM plant DNA, unpredicted changes in the GM protein, transfer of genes to bacteria or human cells, excessive herbicide residues, or accumulation of toxins in the food chain, among others. Clark asks, "Where are the trials showing lack of harm to fed livestock, or that meat and milk from livestock fed on GM feedstuffs are safe?"[22]

Epidemiologist and GM safety expert Judy Carman shows that assessments by Food Safety Australia New Zealand (FSANZ) similarly overlook serious potential problems, including cancer, birth defects, or long-term effects of nutritional deficiencies. [23]

"A review of twelve reports covering twenty-eight GM crops - four soy, three corn, ten potatoes, eight canola, one sugar beet and two cotton - revealed no feeding trials on people. In addition, one of the GM corn varieties had gone untested on animals. Some seventeen foods involved testing with only a single oral gavage (a type of forced-feeding), with observation for seven to fourteen days, and only of the substance that had been genetically engineered to appear [the GM protein], not the whole food. Such testing assumes that the only new substance that will appear in the food is the one genetically engineered to appear, that the GM plant-produced substance will act in the same manner as the tested substance that was obtained from another source [GM bacteria], and that the substance will create disease within a few days. All are untested hypotheses and make a mockery of GM proponents' claims that the risk assessment of GM foods is based on sound science. Furthermore, where the whole food was given to animals to eat, sample sizes were often very low - for example, five to six cows per group for Roundup Ready soy - and they were fed for only four weeks."[24]

Hidden information, lack of standards, and breaking laws Companies claim that their submissions to government regulators are "confidential business information" so they are kept secret. Some industry studies that have been forced into the public domain through Freedom of Information requests or lawsuits have been appalling in design and execution. This is due in part to the lack of meaningful and consistent standards required for assessments. Gurian-Sherman says of the FDA's voluntary consultation, "Some submissions are hundreds of pages long while others are only 10 or 20."[25] A Friends of the Earth report on US regulation and corporate testing practices states, "Without standardization, companies can and do design test procedures to get the results they want." [26] Regulators also reference international standards as it suits them. According to the Centre for Integrated Research in Biosafety, for example, FSANZ "relaxed adherence to international standards for safety testing when that better suited the Applicant's submitted work, and imposed international standards whenever that was a lower standard than we recommended."[27]

Regulators also break laws. The declaration of GRAS status by the FDA deviated from the Food and Cosmetic Act and years of legal precedent. In Europe, the law requires that when EFSA and member states have different opinions, they "are obliged to co-operate with a view to either resolving the divergence or preparing a joint document clarifying the contentious scientific issues and identifying the relevant uncertainties in the data."[28] According to FOE, in the case of all GM crop reviews, none of these legal obligations were followed.[29]

Humans as guinea pigs

Since GM foods are not properly tested before they enter the market, consumers are the guinea pigs. But this doesn't even qualify as an experiment. There are no controls and no monitoring. Without post-marketing surveillance, the chances of tracing health problems to GM food are low. The incidence of a disease would have to increase dramatically before it was noticed, meaning that millions may have to get sick before a change is investigated. Tracking the impact of GM foods is even more difficult in North America, where the foods are not labeled. Regulators at Health Canada announced in 2002 that they would monitor Canadians for health problems from eating GM foods. A spokesperson said, "I think it's just prudent and what the public expects, that we will keep a careful eye on the health of Canadians." But according to CBC TV news, Health Canada "abandoned that research less than a year later saying it was 'too difficult to put an effective surveillance system in place.'" The news anchor added,

"So at this point, there is little research into the health effects of genetically modified food. So will we ever know for sure if it's safe?"[30]

Not with the biotech companies in charge. Consider the following statement in a report submitted to county officials in California by pro-GM members of a task force. "[It is] generally agreed that long-term monitoring of the human health risks of GM food through epidemiological studies is not necessary because there is no scientific evidence suggesting any long-term harm from these foods."[31] Note the circular logic: Because no long-term epidemiological studies are in place, we have no evidence showing long-term harm. And since we don't have any evidence of long-term harm, we don't need studies to look for it. What are these people thinking? Insight into the pro-GM mindset was provided by Dan Glickman, the US Secretary of Agriculture under President Clinton.

"What I saw generically on the pro-biotech side was the attitude that the technology was good, and that it was almost immoral to say that it wasn't good, because it was going to solve the problems of the human race and feed the hungry and clothe the naked. . . . And there was a lot of money that had been invested in this, and if you're against it, you're Luddites, you're stupid. That, frankly, was the side our government was on. Without thinking, we had basically taken this issue as a trade issue and they, whoever 'they' were, wanted to keep our product out of their market. And they were foolish, or stupid, and didn't have an effective regulatory system. There was rhetoric like that even here in this department. You felt like you were almost an alien, disloyal, by trying to present an open-minded view on some of the issues being raised. So I pretty much spouted the rhetoric that everybody else around here spouted; it was written into my speeches."[32]

Fortunately, not everyone feels that questioning GM foods is disloyal. On the contrary, millions of people around the world are unwilling to participate in this uncontrolled experiment. They refuse to eat GM foods. Manufacturers in Europe and Japan have committed to avoid using GM ingredients. And the US natural foods industry, not waiting for the government to test or label GMOs, is now engaged in removing all remaining GM ingredients from their sector using a third party verification system. The Campaign for Healthier Eating in America will circulate non-GMO shopping guides in stores nationwide so that consumers have clear, healthy non-GMO choices. With no governmental regulation of biotech corporations, it is left to consumers to protect themselves. To learn how to opt-out of the eating GMOs and to find non-GM alternative brands, visit www.responsibletechnology.org http://www.responsibletechnology.org/ .
New Book Genetic Roulette Documents Serious Health Dangers

The sourcebook for the Campaign is the newly released Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods. With input from more than 30 scientists over two years, it presents 65 health risks of GM foods and why current safety assessments are not competent to protect us from most of them. The book documents lab animals with damage to virtually every system and organ studied; thousands of sick, sterile, or dead livestock; and people around the world who have traced toxic or allergic reactions to eating GM products, breathing GM pollen, or touching GM crops at harvest. It also exposes many incorrect assumptions that were used to support GM approvals. Organizations worldwide are presenting the book to policy makers as evidence that GM foods are unsafe and need to be removed immediately. But we don't need to wait for governments to step in. We can make healthier choices for ourselves, our families, and our schools now, and together we can inspire the tipping point for healthier, non-GM eating in America. We believe that this can be achieved within the next 24 months. *******
The GM crops sold in the US include soy (including soy lecithin used in chocolate and thousands of other products as an emulsifier), corn (including high fructose corn syrup), cottonseed and canola (both used in vegetable oil), Hawaiian papaya, and a small amount of zucchini and crook-neck squash. There is also alfalfa for cattle (the sale of which was halted by a federal judge on March 13, 2007), GM additives such as aspartame, and milk from cows treated with GM bovine growth hormone. There is not yet any GM popcorn, white corn or blue corn. And the industry is threatening to introduce GM sugar from sugar beets next year. To learn more, for online shopping guides and to find out how to get involved, go to www.ResponsibleTechnology.org http://www.responsibletechnology.org/ .

The Institute for Responsible Technology's plans to achieve the tipping point on GMOs through consumer education has inspired the Mercola.com Foundation to match donations and membership fees to the Institute at this time. Please help end the genetic engineering of our food supply by contributing to the implementation of this important project. Click here http://www.seedsofdeception.com/utility/showPage/index.cfm?objectID=gmfree , 5112 .

Jeffrey M. Smith is the author of the newly released book, Genetic Roulette: The documented health risks of genetically engineered foods. He is the director of the Institute for Responsible Technology and the Campaign for Healthier Eating in America, the international bestselling author of Seeds of Deception, and the producer of the DVD Hidden Dangers in Kids' Meals.

[1] "Monsanto Bribery Charges in Indonesia by DoJ and USSEC," Third World Network, Malaysia, Jan 27, 2005, http://www.mindfully.org/GE/2005/Monsanto-Indonesia-Bribery27jan05.htm

[2] "Greenpeace exposes Government-Monsanto nexus to cheat Indian farmers: calls on GEAC to revoke BT cotton permission," Press release, March 3, 2005, http://www.greenpeace.org/india_en/news/details?item_id=771071

[3] Jeffrey M. Smith, Seeds of Deception, (Iowa: Yes! Books, 2003), 224.

[4] See Federal Food, Drug and Cosmetic Act (FFDCA)

[5] Dan Quayle, "Speech in the Indian Treaty Room of the Old Executive Office Building," May 26, 1992.

[6] See Smith, Seeds of Deception; and for copies of FDA memos, see The Alliance for Bio-Integrity, www.biointegrity.org http://www.biointegrity.org/

[7] Steven M. Druker, "How the US Food and Drug Administration approved genetically engineered foods despite the deaths one had caused and the warnings of its own scientists about their unique risks," Alliance for Bio-Integrity, http://www.biointegrity.org/ext-summary.html

[8] Louis J. Pribyl, "Biotechnology Draft Document, 2/27/92," March 6, 1992, www.biointegrity.org http://www.biointegrity.org/ http://www.biointegrity.org/FDAdocs/04/view1.html

[9] Linda Kahl, Memo to James Maryanski about Federal Register Document "Statement of Policy: Foods from Genetically Modified Plants," Alliance for Bio-Integrity(January 8, 1992) http://www.biointegrity.org http://www.biointegrity.org/

[10] "Statement of Policy: Foods Derived from New Plant Varieties," Federal Register 57, no. 104 (May 29, 1992): 22991.

[11] "Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada; An Expert Panel Report on the Future of Food Biotechnology prepared by The Royal Society of Canada at the request of Health Canada Canadian Food Inspection Agency and Environment Canada" The Royal Society of Canada, January 2001.

[12] Doug Gurian-Sherman, "Holes in the Biotech Safety Net, FDA Policy Does Not Assure the Safety of Genetically Engineered Foods," Center for Science in the Public Interest, http://www.cspinet.org/new/pdf/fda_report__final.pdf

[13] Bill Freese, "The StarLink Affair, Submission by Friends of the Earth to the FIFRA Scientific Advisory Panel considering Assessment of Additional Scientific Information Concerning StarLink Corn," July 17­19, 2001.

[14] FDA Letter, Letter from Alan M. Rulis, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, FDA to Dr. Kent Croon, Regulatory Affairs Manager, Monsanto Company, Sept 25, 1996. See Letter for BNF No. 34 at http://www.cfsan.fda.gov/~lrd/biocon.html

[15] See for example, "Good Enough To Eat?" New Scientist (February 9, 2002), 7.

[16] "Health risks of genetically modified foods," editorial, Lancet, 29 May 1999.

[17] "Elements of Precaution," The Royal Society of Canada, January 2001.

[18] Friends of the Earth Europe, "Throwing Caution to the Wind: A review of the European Food Safety Authority and its work on genetically modified foods and crops," November 2004.

[19] Friends of the Earth Europe and Greenpeace, "Hidden Uncertainties What the European Commission doesn't want us to know about the risks of GMOs," April 2006.

[20] European Communities submission to World Trade Organization dispute panel, 28 January 2005.

[21] Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, Fairfield, IA USA 2007

[22] E. Ann Clark, "Food Safety of GM Crops in Canada: toxicity and allergenicity," GE Alert, 2000.

[23] FLRAG of the PHAA of behalf of the PHAA, "Comments to ANZFA about Applications A372, A375, A378 and A379."

[24] Judy Carman, "Is GM Food Safe to Eat?" in R. Hindmarsh, G. Lawrence, eds., Recoding Nature Critical Perspectives on Genetic Engineering (Sydney: UNSW Press, 2004): 82­93.

[25] Doug Gurian-Sherman, "Holes in the Biotech Safety Net, FDA Policy Does Not Assure the Safety of Genetically Engineered Foods," Center for Science in the Public Interest, http://www.cspinet.org/new/pdf/fda_report__final.pdf

[26] William Freese, "Genetically Engineered Crop Health Impacts Evaluation: A Critique of U.S. Regulation of Genetically Engineered Crops and Corporate Testing Practices, with a Case Study of Bt Corn," Friends of the Earth U.S., http://www.foe.org/camps/comm/safefood/gefood/index.html

[27] M. Cretenet, J. Goven, J. A. Heinemann, B. Moore, and C. Rodriguez-Beltran, "Submission on the DAR for Application A549 Food Derived from High-Lysine Corn LY038: to permit the use in food of high-lysine corn, 2006, www.inbi.canterbury.ac.nz

[28] EU Regulation 178/2002 (Article 30)

[29] Friends of the Earth Europe, "Throwing Caution to the Wind: A review of the European Food Safety Authority and its work on genetically modified foods and crops," November 2004.

[30] "Genetically modified foods, who knows how safe they are?" CBC News and Current Affairs, September 25, 2006.

[31] Mike Zelina, et al., The Health Effects of Genetically Engineered Crops on San Luis Obispo County," A Citizen Response to the SLO Health Commission GMO Task Force Report, 2006.

[32] Bill Lambrecht, Dinner at the New Gene Café, St. Martin's Press, September 2001, pg 139.