Category Archives: Genetic Engineering

I have frequently pointed out that pharmaceutical companies acknowledge that animal models are not predictive for human response in terms of efficacy or toxicity. More evidence for this position comes from Robert G. Hunter in an article in Genetic Engineering & Biotechnology News.[1] Hunter: Having developed over the past 20 years into a global market recently estimated at $5 billion, in vitro and in silico products and services are now about the same size as the in vivo services (contract research organization) industry. If animal models worked well, there would be no need for industry to look at other options. Pharma does not love bunnies. Pharma loves money.

Matthew Herper addressed the problems in drug development in an article in Forbes.[2] Herper:

Theres one factor that, as much as anything else, determines how many medicines are invented, what diseases they treat, and, to an extent, what price patients must pay for them: the cost of inventing and developing a new drug, a cost driven by the uncomfortable fact than 95% of the experimental medicines that are studied in humans fail to be both effective and safe.

Animal models are relied on for the evaluation of both efficacy and safety.[3-9] Herper continues:

A new analysis conducted at Forbes puts grim numbers on these costs. A company hoping to get a single drug to market can expect to have spent $350 million before the medicine is available for sale. In part because so many drugs fail, large pharmaceutical companies that are working on dozens of drug projects at once spend $5 billion per new medicine. . . . This is crazy. For sure its not sustainable, says Susan Desmond-Hellmann, the chancellor at UCSF and former head of development at industry legend Genentech, where she led the testing of cancer drugs like Herceptin and Avastin. Increasingly, while no one knows quite what to do instead, any businessperson would look at this and say, You cant make a business off this. This is not a good investment. I say that knowing that this has been the engine of wonderful things.

This, in part, is why disease-specific drugs like Kalydeco, a drug for cystic fibrosis (CF) patients that have a specific genetic mutation, costs $294,000 per patient per year.

The reason animal models fail for drug development is that animals and humans are evolved systems that are differently complex. While morphological similarities exist, very small differences in the genetic make-up between species and between individuals of the same species means the predictive value for extrapolation is nil in the real world. (For more on this see Trans-Species Modeling Theory.) Moreover, if the concept of evolved, complex systems invalidates trans-species extrapolation in drug development, it is going to do the same when trans-species extrapolation involves any perturbation that affects higher levels of organization. So just based on the evidence from drug development we can safely say that disease research on mice, monkeys, or dogs is not going to result in knowledge that has predictive value for human patients. The literature confirms this.[10-21][[22]p19-33, 73-77] [23-25]

Compare the above to this recent statement from Michael E. Goldberg published in the Wisconsin State Journal: Nearly every medical advance from the last century is a product of responsible animal research, and animal models will continue to be important to medical progress. . . . Activists who claim animal research does not benefit humans are wrong. Animals are essential to medical progress in all fields of human disease. [26] This illustrates the dichotomy regarding animal models. Dr Goldberg is an animal modeler who does basic research, which he sells as applied research. Not surprisingly, Goldberg thinks animal modeling is great. He does not suffer loss of income or prestige when the knowledge from animal modeling fails to translate to human patients.

Pharma on the other hand, can actually measure the success or lack thereof of animal models in the form of drugs successfully brought to market and Pharma says it doesnt work. Remember, Pharma is a business and they do not care how they develop new drugs they just want to develop new drugs so they can make money. Also remember that there are not two different theories of evolution: one for drug development and another for basic science research or basic research masquerading as applied research. If animal modeling in drug development fails to be consistent with evolutionary biology, then it fails in general as well.

Image courtesy of Wkipedia Common http://en.wikipedia.org/wiki/File:Chromosomes_mutations-en.svg

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There is Only One Evolution

Carp species are found to live successfully in the Great Lakes, but at what price?

Blocking Asian carp from invading the Great Lakes could require an engineering marvel that rivals the reversal of the Chicago River more than a century ago, according to a new federal study that promises to reignite a fierce debate about the region's waterways.

Among the options outlined Monday by the Army Corps of Engineers to thwart the voracious fish and other invasive species from spreading is permanently separating Lake Michigan from the river and its connected waterways. Such a project would restore the once natural divide between the Great Lakes and rivers southwest of Chicago that drain into the Mississippi River.

Chicago blasted through that hydrological barrier when it dug the Sanitary and Ship Canal and Cal-Sag Channel at the turn of the last century to divert the region's sewage away from its source of drinking water. It also created a shipping link between two of the nation's major trade routes.

Separating the lake and the river again could cost more than $18 billion and take up to 25 years, the Corps' study concluded, making that option the most expensive of the eight studied. Another option, carrying a $15 billion price tag, would allow portions of the Chicago River, Sanitary and Ship Canal and Calumet River to flow into Lake Michigan.

Reflecting the development of Chicago from a swampy prairie outpost to a sprawling city, both of those options would require a multibillion investment in giant stormwater tunnels and massive flood-control reservoirs, according to the study.

Several political leaders said the potential cost and time frame could scuttle the plan before Congress considers it.

"I've seen too many of these long-term Corps projects languish for years and fall victim to congressional inaction," said U.S. Sen. Dick Durbin, the Illinois Democrat and assistant Senate majority leader. "We can't gamble with the threat of Asian carp ... or risk severe flood damage to the Chicago metropolitan area by pursuing a risky plan at the expense of our current efforts."

A lobbyist for one of the industries that still relies on the river system was even more blunt. The study "clearly indicates that physical separation is too expensive, too slow and too uncertain to be a viable solution to the spread of invasive species," said Mark Biel, executive director of the Chemical Industry Council of Illinois.

Two years in the making, the study comes amid a series of alarming findings that raise the possibility it might be too late for new federal action to stop Asian carp from getting into the Great Lakes and threatening the region's $7 billion fishing industry.

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Engineering marvel may be needed to stop Asian carp

PUBLIC RELEASE DATE:

7-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, January 7, 2014African American men have an increased risk of prostate cancer and are two times more likely than Caucasian American men to die from the disease. Despite recent questions about the overall usefulness of prostate-specific antigen (PSA) testing to detect prostate cancer, should PSA screening be used to detect early-stage disease to help save lives in this at-risk population? The controversy is explored in a Review article in Journal of Men's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Men's Health website at http://www.liebertpub.com/jomh.

In the Review "PSA Screening for the African American Male: When and Why?" Tyler Luthringer, Ilija Aleksic, Vladimir Mouraviev, and David Albala, Associated Medical Professionals of NY, PLLC, and SUNY Upstate Medical University, Syracuse, support the American Urological Association's position that early detection of prostate cancer should include multiple parameters to assess personal risk. Together with their physicians, men should decide on an individualized approach to risk assessment and screening, which may include PSA testing and digital rectal examination.

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Increased risk of prostate cancer in African American men; implications for PSA screening

A fight over whether to require genetically modified foods to be labeled in New Hampshire is coming before the House this month.

Supporters argue New Hampshire residents have a right to know whether their food is produced with genetic engineering, but critics say the federal Food and Drug Administration has not mandated the labeling because it determined the foods are safe.

The House Environment and Agriculture Committee split in its recommendation on the bill, with a majority favoring killing it. But a minority is arguing its time for states like New Hampshire to lead, regardless of the federal position on the issue.

While we have concerns about the lack of safety and health testing by parties independent of the bio-tech industry, we are not opposed to the use of (genetic engineering) technology per se. We simply feel that people should have the freedom to make their own choices about food, and since knowledge is essential to the proper exercise of that freedom, information about genetically engineered content should be available on food labels, state Rep. Peter Bixby wrote to the House.

But state Rep. Robert Haefner countered in his message to the House on the bill that a label would in effect serve as a skull and crossbones, suggesting to the consumer that there is something dangerous in the product when in fact science has shown there is not.

Haefner said the bill would be difficult and expensive for the state to enforce.

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GMO bill to go before the House this month

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Margaret Smith is a professor of plant breeding and genetics who leads a Cornell University program to help farmers and the public understand plant breeding and genetic engineering. She says the recent move by General Mills to eliminate genetically modified organisms from its Cheerios cereal might please GMO-shy consumers, but it won't alter the iconic cereals make up one bit.

Smith says:

Corn starch and sugar are highly refined products, so they contain no DNA (which is what is introduced into a genetically engineered organism) and no protein (which is what the new DNA would produce in a genetically engineered organism). Because of that, corn starch and sugar from a genetically engineered corn variety are nutritionally and chemically identical to corn starch or sugar from a non-genetically engineered variety.

This means that the new version of Cheerios that is being made without use of genetically engineered varieties will be nutritionally and chemically identical to the previous version. So it will not offer anything new to consumers other than to give them the option to buy a product that does not support planting more acres to genetically engineered crop varieties.

Cornell University has television, ISDN and dedicated Skype/Google+ Hangout studios available for media interviews.

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Plant Genetics Expert - in the Bowl, GMO-Free Cheerios Identical to Current Crop

Bohemia, NY (PRWEB) January 03, 2014

Colle Farmers Market, an organic food advocate, responds to an article published by Surfer Magazine on December 18th, which discusses the protests involving genetic engineering on Hawaiian soil.

According to the Surfer Magazine article titled Surfers Say No to GMOs, Hawaiian citizens and organic advocates were protesting against the genetic engineering experiments happening in Hawaii. The article says Kamehameha Schools leased 1000 acres of land to Monsanto, the company that has been performing the genetic modification experiments.

Most developed countries have banned this type of experimentation, mainly because of the potential environmental harm these experiments could have. However, genetically modified organisms (GMOs) and genetically engineered foods are still legal in the United States.

The article says, "This push came on the heels of the recently passed Kauai Bill 2491legislation requiring companies to disclose their use of GMOs, pushed through after the city council overturned the mayors veto weeks before the opening of Hawaiis legislature."

A representative from Colle Farmers Market, an organic food advocate, says if more people adopted an organic lifestyle, the amount of GMO foods will decrease. We should be eating food the way nature intended, he says. Organic food is all natural, and free from preservatives, chemicals, and pesticides. Humans were not designed to eat food made in a lab or developed with chemicals. We were made to eat fresh food. GMOs are genetically engineered organisms that are produced in a lab and have the potential to significantly harm our bodies and environment.

The Colle rep says organic food also helps to keep the soil healthy. GMOs and conventional farming can have horrible affects on the ground soil, he says. By advocating and adopting an organic lifestyle, farmers and consumers can ensure help keep the environment healthy. We applaud these Hawaiians and surfers for standing up for what they believe in and raising awareness.

Colle Farmers Market is an E-Commerce enabled farmers market community that is passionate about sustainable consumption and responsible conservation. The Colle movement is dedicated to connecting natural product vendors, organic farmers and all people who are living an organic and natural lifestyle.

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Organic Food Advocate, Colle Farmers Market, Comments on Hawaiian Surfers Protesting Genetic Engineering

One of the toughest problems facing embryonic stem cell therapy, immune rejection of transplanted cells, may have been solved, according to a UC San Diego-led research team.

The cells can be made invisible to the immune system by genetically engineering them to make two immune-suppressing molecules, according to the study. Researchers tested the approach in mice given a human immune system. Immune functioning in the rest of the animal remained active.

If the approach works in people, patients receiving transplanted tissue or organs made from embryonic stem cells wouldnt have to take harsh immune-suppressing drugs, said study leader Yang Xu, a UC San Diego professor of biology.

Human embryonic stem cells. The green markers indicate the presence of a protein expressed only in these cells. / Samantha Zeitlin, 2006 CIRM fellow

Researchers placed genes in the stem cells to produce the two molecules, called CTLA4-lg and PD-L1, naturally made in the body. The mice accepted transplants of heart and skin cells derived from the engineered stem cells. They rejected transplants derived from regular embryonic stem cells.

The study was published online Thursday in the journal Cell Stem Cell. Its findings will have to be confirmed for safety and effectiveness before human trials can be considered, which will take years.

Three scientists given the paper for comment had mixed reactions. While they praised the works scientific prowess, two said genetically engineering the transplanted cells could cause serious side effects that might preclude their use.

The researchers employed a clever strategy to use the immune systems natural regulatory systems, said Mitchell Kronenberg, president of the La Jolla Institute for Allergy & Immunology.

This is an especially promising approach, because it avoids the toxic side effects of the drugs now used to suppress the rejection response, and therefore this is an important step forward in showing the feasibility of using human embryonic stem cells from unrelated donors, Kronenberg said.

More skeptical were Jeanne Loring, a stem cell researcher at The Scripps Research Institute, and Craig M. Walsh, associate director of the Institute for Immunology at UC Irvine.

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Embryonic stem cell rejection problem fixed, study says

PUBLIC RELEASE DATE:

2-Jan-2014

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, January 2, 2014Minority women tend to be less aware of the increased risk of cardiovascular disease (CVD) they face by being overweight or obese. The results of a study that compared Hispanic and non-Hispanic white women based on their knowledge of heart disease risk factors and their perceptions of their own weight is published in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Women's Health website at http://www.liebertpub.com/jwh.

Elsa-Grace Giardina, MD and coauthors, Columbia University Medical Center (New York, NY), report that although awareness of CVD and recognition that heart disease is the leading cause of death among women in the U.S has increased, knowledge of these risk factors still remains low among minority women, making prevention efforts more difficult. The authors compared how women estimate their weight and view their risk of heart disease and present their findings in the article "Cardiovascular Disease Knowledge and Weight Perception Among Hispanic and Non-Hispanic White Women."

"Based on these findings, prevention strategies need to target CVD knowledge and awareness among overweight and obese Hispanic women," says Susan G. Kornstein, MD, Editor-in-Chief of Journal of Women's Health, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health.

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About the Journal

Journal of Women's Health, published monthly, is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. The Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women's healthcare issues. Complete tables of content and a sample issue may be viewed on the Journal of Women's Health website at http://www.liebertpub.com/jwh. Journal of Women's Health is the Official Journal of the Academy of Women's Health and the Society for Women's Health Research.

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Hispanic women are less aware of weight and heart disease risk

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