EPA Appears To Be Backing Off From The Discredited Linear No Threshold Theory

August 5, 2019 By Michael D. Shaw @ Health News Digest

This is good news, but requires a bit of explanation. The Linear No Threshold Theory, aka the Linear Non-Threshold Theory, aka the Linear No Threshold Model (abbreviated LNT), was originally developed regarding exposure to ionizing radiation. LNT holds that additional cancer risk is linear with respect to the absorbed dose, and becomes zero only at zero dose. Thus, there is no threshold below which there is no effect. This model is used as the basis of most nuclear-related legislation around the world, and in some chemical risk assessment.

LNT was controversial from its introduction, and became even more so once it was applied to chemical exposures. After all, if the dose makes the poison, and the dose is diluted down to one molecule, how harmful could it be? Intuitively, there must be a threshold. If not, then no pharmaceutical drug could ever be safe. Or as my toxicologist friend Dr. Robert Golden once put it, “If there is no safe level, then why bother doing risk assessments at all?”

There is much literature extant disputing LNT, including this extensive review article from 2018, which concludes:

Objectively evaluating and incorporating the latest scientific evidence on LDDR (low dose, low-dose rate) dose-response relationships for application to the regulatory and policy-making process for risk assessment purposes will (1) ensure science remains the foundation for its decision making, (2) reduce the unnecessary burden of costly cleanups, (3) provide a much needed platform to educate the public on the risks or benefits from LDDR radiation exposures, and (4) harmonize the agency’s policies with those recognized by the rest of the radiation scientific community. A continued resistance to conducting a comprehensive review of the latest science regarding LNT-based policies will only diminish the agency’s [EPA’s] credibility and influence to protect human health and the environment.

The notion of LNT is based on the work of Nobel Laureate Hermann Muller, who won the 1946 Nobel Prize in physiology or medicine for his discovery that X-rays induce genetic mutations. In his Nobel Lecture (December 12, 1946), Muller declared that there is “no escape from the conclusion that there is no threshold dose.”

However, according to the extensive work of toxicologist Edward Calabrese, it is highly probable that at the very time Muller gave this lecture, he already knew that his contention was untrue. More than that, Muller actively conspired to suppress contrary findings for years.

Which brings us to recent activity of EPA’s Science Advisory Board (SAB). On July 15th, the Board posted a report entitled “Consultation on Updating EPA Guidelines for Carcinogen and Non-Cancer Risk Assessment.” The report first states the charge questions, which cover aspects of EPA’s risk assessment guidelines, with frequent reference to dose-response issues. The next two sections of the report include individual comments from members of the SAB on these questions.

The comments were conveyed as such because EPA administrator Andrew Wheeler specifically requested individual advice from the board members, rather than seeking consensus recommendations.

Member Kimberly White, with the American Chemistry Council, noted that, “There is considerable empirical evidence of non-linearity in dose-response modeling and the Agency should evaluate its reliance and application of default models that limit the consideration of alternative approaches. Decades of peer reviewed published literature provide multiple examples of observed chemical specific thresholds for both non-cancer and cancer endpoints.”

Member Dennis Paustenbach, an independent consultant, agrees: “It is clear to me, although not everyone would agree, that the linearized multi-stage model is unable to account for the dozens of compensatory mechanism that clearly exist at low doses which render virtually all chemicals to be harmless at those levels. Dozens of papers of the past 15-20 years that have attempted to study such doses in whole animal studies seem to clearly show this to be true.”

Member Brant Ulsh, Principal Health Physicist with M.H. Chew & Associates cites numerous references criticizing LNT, which have heretofore been ignored by the EPA…

“In spite of these cautions and caveats, the Agency continues to claim that there is consensus for their application of LNT to estimate risks from low radiation doses and set cleanup standards. In fact, there is wide disagreement on application of the LNT model among expert advisory bodies, professional societies, and individual scientists.”

“The Agency’s assertion that assuming linearity is protective of public health is presented without evidence and is in fact contradicted by the experiences of the Chernobyl and Fukushima accidents. In those situations, public health responses based on the LNT model of radiation risks were retrospectively found to have done more harm than good.”

There is little doubt that EPA should abandon Linear No Threshold.

Is Fear of Radiation Bad for Your Health?

Fraudulent science behind radiation regulations

Radiation scientist documents fraud in Nobel award for “Linear No Threshold” toxicity model

Paul Driessen and Dr. Jay Lehr

The 2018 elections underscore the need for bipartisan efforts to address scientific frauds that promote and justify ever more stringent regulations – often to the great detriment of people, patients and society.

In fact, world-renowned toxicology expert Dr. Edward Calabrese has now discovered and documented fraud behind the award of the 1946 Nobel Prize for Physiology or Medicine. The prize was given to Hermann Muller for his claimed discovery that even small or infinitesimal amounts of radiation can cause cancer. It is the ridiculous assertion that there is no threshold below which any kind of radiation is safe.

By contrast, toxicologists have long used actual experiments to establish a dose response model and determine what exposure to various kinds of radiation (or chemicals) actually pose cancer (or other risks) risks for humans.

Low doses are generally benign, they have found. In many cases, they even help animals and humans ward off disease, safeguard bodies against certain chemicals or diseases, or actually cure cancer and other diseases. Higher doses can cause problems, and therefore must be calculated and regulated.

For example, via a process called hormesis, low levels of radon exposure can protect against cancer; 80 milligrams of aspirin are thought to prevent strokes; and trace amounts of selenium help our bodies counteract the harmful effects of mercury in our blood.

However, despite this evidence, government agencies like the U.S. Environmental Protection Agency have followed Muller’s straight-line Linear No Threshold (LNT) model for decades. Besides giving rise to what many say are overly restrictive and even unnecessary regulations, the LNT model has actually harmed patients, by greatly precluding the use of radiation in curative medicine.

But now University of Massachusetts at Amherst health sciences professor Calabrese has documented LNT fraud through an exhaustive review of communications that began July 22, 1927 in the journal Science, where Muller first put forth the claim that any amount of radiation causes cancer. Calabrese lays out his findings in an October 2018 paper in the Philosophy, Ethics and Humanities in Medicine journal. an

Calabrese has spent years investigating Muller’s claims. His story unfolds like a detective novel with all the characters who played intentional or inadvertent roles in the deception indicted by their written and published communications 90 years ago. There are 34 documents in all.

They show that, without any supporting scientific data or peer review, Muller presented his claims at the Fifth International Genetics Congress in September 1927, where he described how he had supposedly induced hundreds of gene mutations by bombarding common fruit flies (Drosophila) with x-rays.

Muller’s closest friend and colleague, William Rice Institute biologist Edgar Altenburg, told Muller his experiment had not caused any mutations. Instead, they created changes by eliminating pieces of the flies’ chromosomes, enabling the creation of inheritable traits or progeny, but no mutations whatever.

As early as 1929, in a paper in the Journal of Genetics, geneticist Barbara McClintock demonstrated that Altenburg’s criticism of Muller were correct. She went on to win the 1983 Nobel Prize for her other work in genetics.

However, Muller repeatedly brushed off his friends’ advisories about his error and McClintock’s proof that his hypothesis was incorrect. The recriminations may have led to Muller’s failed suicide attempt in 1932. His suicide note was directed to Altenburg, rather than his family, and Altenburg never challenged Muller again. It appears that loyalty to a close friend may have overwhelmed his responsibility to science, medicine and humanity.

The scientific community was enthralled by Muller’s claims and the publicity it received. Scientists worldwide quickly and uncritically came to believe that Muller actually had produced gene mutations and was advancing one of the most significant questions confronting biology. His lack of data never slowed down the wave of excitement.

Muller resumed his duplicity quite strongly throughout the years leading to his Nobel Prize lecture on December 12, 1946. There he deliberately deceived the audience by arguing that there was no possibility of a threshold or harmless dose response for radiation-induced mutations.

Calabrese documents that Muller had seen data that supported exactly that conclusion. It came from two scientists, Ernst Caspari and Curt Stern, who worked at the University of Rochester and released their findings one month prior to Muller’s Nobel Lecture. Muller ignored their findings and promoted his deception to support his long-held commitment to his Linear No Threshold claim, which is commonly referred to as LNT dose response for mutation and cancer risks.

Muller’s story is one of unbridled ambition, self-serving manipulation, a scientific community that at many levels failed to demand accountability, and a Nobel Prize committee that inadequately evaluated the findings which lead to the award. The implications of these actions have been incredibly damaging.

They resulted in the U.S. National Academy of Sciences adopting the LNT in 1956 for all regulatory programs relating to radiation. This convention was subsequently adopted worldwide.

The deceptions facilitated a continuing impact on society that continues to the present day, without any acknowledgement or change by the scientific community or government regulatory agencies.

Incredibly, modern nucleotide analysis methods have repeated Muller’s experiments with x-ray bombardments – and shown conclusively that Muller’s alterations to fruit flies resulted in modest to extraordinarily large chromosomal deletions, rather than point mutations.

In addition, the 2011 Fukushima nuclear disaster was exacerbated by a commitment to the LNT, which persuaded the Japanese government to mandate that people be moved unnecessarily miles from their homes. That led to an estimated 1,600 premature elderly deaths due to stress.

Not a single radiation illness or death occurred, because there was never enough radiation lasting long enough in the prevailing winds to cause either. But the Fukushima fear lasted for years afterward.

Most amazing and distressing of all, they have led to the rejection of low-dose radiation (LDR) treatments. Underscoring how devastating this can be for patients, Dr. Kiyohiko Sakamoto gave himself total-body LDR treatments for his systemic stage IV colon cancer. Thus far, he is a 20+ year survivor!

In his landmark paper, Calabrese says, regardless of Muller’s deceit, “the most significant criticisms and concerns should be directed to the scientific and regulatory communities, such as U.S. EPA, that have uncritically adopted and sustained Muller’s findings as the foundation for cancer risk assessment.”

They have permitted this process to be dominated by ideological perspectives that must end if healthcare is to be optimized by using low dose radiation to arrest or cure cancers, and prevent needless deaths.

The reasons behind this travesty of science and medicine are simple. First, prominent scientists do not like to be found incorrect on major issues. Second, an activist anti-nuclear population views all radiation as evil, whether that view is rational, irrational or actually harmful to people’s health and welfare.

Hopefully, a “refreshed” House of Representatives and stronger Republican Senate will team up with the White House to correct an egregious wrong that has negatively impacted the health of cancer victims and others who most need advanced radiation treatments that have too long been rendered unavailable.

Any LNT changes will likely be resisted by environmental and health activists and others committed to the status quo. However, Congress, EPA, the Food and Drug Administration, and other regulatory bodies worldwide need to reexamine and revise existing LNT rules. Countless lives hang in the balance.

Paul Driessen is policy advisor for the Committee For A Constructive Tomorrow and author of articles and books on natural resource issues. Dr. Jay Lehr is science director for The Heartland Institute Arlington Heights, Illinois.