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Aug
01

1 of the 2,000 Articles Supporting GMO Safety

Posted under ag biotech, animal testing, Blog, Companies, Diagnostics, Farmer Gene, FDA, Food And Agriculture, Funding, GMO, GMO crops, GMO Food, GMO safety, Medical Devices, Medical Supply, Pharmaceuticals, proteins, Startups, toxic, toxicity, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization) Farmer Gene

On Thursday July 24, 2014, The Huffington Post published a blog titled Genetically-Modified Organisms (GMOs) Have NOT Been Proven Safe. The title alone made me question the author’s integrity. Personally, I was expecting the author to cite some academic sources to make such a claim; after reading the blog, it was clear that the author’s title did not reflect the true narrative of her logic. Her main argument for making this bold claim is that just because GMO’s are safe for  animal use does not mean it is safe for humans. She then compares GMO’s to artificial sweeteners, and warns us that these are similar cases.

Animal studies have value in that if something demonstrates harm in animals, it will also likely cause harm in humans. Although some animal studies have found harm from a GMO diet, these hotly debated studies are not the point of this article. The point is, if an animal study does not find harm with a particular substance, it could still cause harm in humans.

Firstly, GM foods are not molecularly similar to artificial sweeteners at all. There have been instances where toxic elements are apparently found in artificial sugar, like chlorine, toxic elements that are not found in GM foods.

In a juvenile sense, this claim is easily understood by readers. However, toxicity in GM foods are thoroughly tested in labs beyond just animal testing. Moreover, it is illegal, and impossible to do lengthy studies on humans, period. The article does reference a scholarly article which states that epidemiology studies are more effective then animal studies to determine toxicology in humans, but if you look at the date it was published in 2004, and there has been a decade of research since then to help further investigate and mimic human testing, without the use of people as subjects.

To help illustrate this point, I would like to reference a scholarly article from Critical Reviews in Toxicology titled, Toxicological evaluation of proteins introduced into food crops.

This [study] focuses on the toxicological evaluation of proteins introduced into GM crops to impart desired traits. In many cases, introduced proteins can be shown to have a history of safe use. Where modifications have been made to proteins, experience has shown that it is highly unlikely that modification of amino acid sequences can make a non-toxic protein toxic.

Basically, the authors are performing a scientific experiment to test whether the proteins produced by GM crops can potentially be toxic, even if the protein becomes denatured, which means losing function due to excess heat like or pH changes. Through a series of experiments, the results concluded there were no toxic features in the protein, regardless of animal testing.

  1. The introduced protein was structurally/functionally similar to a family of related proteins that have a (History of safe use) in food, based on bioinformatics analysis and literature review.
  2. The introduced protein was readily digested in vitro with simulated digestive fluids regardless of heat, pH and incubation.

Anti-GMO activists claim that the research has not been done, and there is no proof of safety, however the mentioned experiment is just one of the 2,000 peer reviewed scientific papers that has supported genetic modification safety.

But regardless of amount of scientific research that supports GMO safety, the FDA and the EPA must approve before any GMO hits the market:

The developer produces a safety assessment, which includes the identification of distinguishing attributes of new genetic traits, whether any new material in food made from the GE plant could be toxic or allergenic when eaten, and a comparison of the levels of nutrients in the GE plant to traditionally bred plants.

FDA scientists evaluate the safety assessment and also review relevant data and information that are publicly available in published scientific literature and the agency’s own records.

The consultation is complete only when FDA’s team of scientists are satisfied with the developer’s safety assessment and have no further questions regarding safety or other regulatory issues.

I chose to write a response for this blog for two reasons. One: The Huffington Post attracts a lot of attention from young adults,  like me, due to their influence on social media; I don’t want my peers to be lectured on a controversial topic that uses false claims. Two: I am biology major; I see science as a tool to help make this world a better place because it is the closest thing we have to fact. Part of the nature of a scientist is to question fact, and to find creative procedures to further test fact. I encourage future readers to do the same when they read “science” about GMO’s.

Aug
01

Treating Hepatitis C: Too Costly Not to Act

Posted under Blog, California Healthcare Institute, CHI, Companies, Diagnostics, Funding, Health, Health Care, healthcare, hepatitus c, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

Today, The Hill published an op-ed – Treating hepatitis C: Too costly not to act – by California Healthcare Institute’s Todd Gillenwater on the value of breakthrough Hepatitis C medicines that cure the disease in the majority of patients.

As Gillenwater asserts, “New hepatitis C drugs mark a paradigm shift – from a model of somewhat iffy but costly chronic care to a model of short-term curative treatment with equal or slightly lower costs paid upfront.”

Together with the Boston Consulting Group, CHI released a report – Innovation in Hepatitis C Treatment: New Opportunities for Action – that highlights the public health impact of hepatitis C and the potential of groundbreaking new treatments to save tens of thousands of lives over the coming decades.

As stated in the report, “Using a model developed by the Center for Disease Analysis, we estimate that new hepatitis C drugs could save 30,000 lives over the next 15 years when compared to the recent standard of care. In addition, the new medicines could prevent 16,000 cases of liver cancer and resulting liver transplants – a procedure that costs more than $500,000. With just a 5 percent increase in the number of patients screened and treated with these new medicines, 27,000 additional deaths from hepatitis C could be prevented – that’s nearly 60,000 lives saved over the next 15 years.”

Read the full op-ed here, and visit the California Healthcare Institute’s web site here.

Gillenwater is president & CEO at CHI-California Healthcare Institute (CHI). CHI represents more than 275 leading biotechnology, medical device, diagnostics, pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance biomedical research, investment and innovation through effective advocacy of policies to improve public health and ensure continued vitality of the life sciences sector.

Aug
01

Lilly, Boehringer win FDA approval for once-rejected diabetes drug

Posted under Blog, Boehringer Ingelheim, Companies, Diagnostics, Eli Lilly, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, SGLT2 drugs, Startups, Universities, Videos by Damian Garde

After a manufacturing issue scuttled their first attempt, Eli Lilly and Boehringer Ingelheim have won the FDA's blessing to market their new diabetes drug, a late entrant into a crowded space.

Aug
01

Loxo pulls off a $68M IPO to bankroll its cancer pipeline

Posted under Biotech IPOs, Blog, Companies, Diagnostics, Funding, Loxo Oncology, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by Damian Garde

Connecticut's Loxo Oncology nailed down about $68 million in an up-sized IPO, filling its coffers as it works up some targeted cancer therapies.