Saturday, June 30, 2018
Pot businesses urge California to delay strict testing rules
Friday, June 29, 2018
House Passes SUPPORT for Patients and Communities Act to Combat America's Opioid Crisis
Opioid abuse and addiction in America has reached epidemic heights. As a nation, we're spending more than $500 billion annually in health and social costs to combat this growing problem. What's more, the Department of Health and Human Services reports more than 40,000 lives lost in 2016 from overdosing on these pain management treatments.
Long-term solutions to combating this crisis will depend upon biomedical innovation and the development of novel and safer, next generation therapies to treat both pain and addiction.
Last week, the House of Representatives passed important legislation designed to help address this epidemic and to ensure that more innovative treatments are available to patients. The bill, H.R. 6 (the Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment – SUPPORT – for Patients and Communities Act), included several of BIO's recommendations pertaining to enhancing and improving the ability to utilize expedited approval pathways, which is an important step in getting new innovations to patients.
Specifically, the SUPPORT for Patients and Communities Act would require the Food and Drug Administration (FDA) to hold a public meeting within one year and update or develop new guidance documents covering topics such as:
- The use of innovative clinical trial designs, real world evidence, and patient experience data for the development of therapies for treating pain and addiction;
- Eligibility criteria for Sponsors to qualify for expedited approval pathways;
- Methods for evaluating acute and chronic pain; and
- Possible endpoints for use in clinical trials for pain and addiction therapies
By clarifying these points and the criteria for expedited approval qualifications, we can encourage greater investment into the development of much-needed novel and safer therapies.
The reality is that it often is not clear to companies who are developing therapies in this area as to whether they qualify for expedited approval pathways or what the FDA's expectations are for qualifying for such pathways. Additionally, inefficient tools for evaluating pain, like the current "1-10 scale" which does not consider acute versus chronic pain, pain perception, or other comorbidities such as depression and a lack of endnotes makes clinical trials for pain and addiction therapies more difficult.
The legislation, by providing Industry Sponsors and investors a clear path forward through regulatory clarity, would also help support the discovery and utilization of less-addictive medicines – a critical component of a comprehensive plan to solve the opioid crisis.
To date there have been several bills introduced in both Chambers to fight against this growing crisis and we applaud Congress' hard work in advancing these critical pieces of legislation.
BIO will continue working to promote policies to fight this disease by encouraging the research and development, as well as the timely approval of, and patient access to, novel medicines that improve the way we treat pain and addiction for current and future generations.
For more information about the biopharmaceutical industry' commitment to combatting the opioid crisis, please visit http://www.bio.org/opioid.
Wednesday, June 27, 2018
New Report Offers “Distorted View” of Biopharma Industry
This week, the Minority Staff of the U.S. Senate Committee on Finance released a report entitled, "A Tangled Web: An Examination of the Drug Supply and Payment Chains." The report is the latest to look at the nation's complex drug cost ecosystem.
More patients are finding that what they have to pay for prescription drugs is simply unaffordable. That's why BIO has repeatedly called on policymakers to advance reforms that will help provide all patients affordable access to the medicines they need. Real reform requires a holistic approach, one that recognizes the roles insurers, pharmacy benefits managers, hospitals and other health care actors play in determining what people pay for their prescription drugs.
Unfortunately, this report provides a distorted view of the biopharmaceutical industry. For example, it doesn't mention the fact that 90% of all biopharmaceutical companies are unprofitable and most biotech companies are small businesses. It also fails to recognize that when compared to other industries, the biotech sector collectively ranks near the bottom in terms of profitability. Finally, it gives scant attention to the tremendous value biopharmaceutical innovation provides patients and our broader health care system.
Biopharmaceutical innovators invest enormous amounts of time and resources bringing new cures and treatments to market, yet a large share of what's spent each year on prescription drugs goes to insurance companies and other middlemen. While we disagree with the conclusions in this report, we have long been encouraging policymakers to carefully review the complex way drugs are delivered to patients. We believe such an effort will ultimately lead to real solutions that provide all patients access to the medicines they need at a cost they can afford.
Tuesday, June 26, 2018
As More Countries Adopt Crop Biotechnology, Farm Families and the Environment Benefit
Biotech crops in the last 22 years have brought enormous benefits to the environment, health of humans and animals, and contributions to the improvement of socio economic conditions of farmers and the general public, according to a new report issued today by the International Service for the Acquisition of Agri-biotech Applications (ISAAA).
The ISAAA report shows the global biotech crop area increased in 2017 by 3 percent or 4.7 million hectares or 11.6 million acres; Global economic gains contributed by biotech crops in the last 21 years (1996-2016) have amounted to US $186.1 billion economic benefits to more than 16 to 17 million farmers, 95 percent of whom come from developing countries.
As more developing countries, now 19 in total including India, Pakistan, Brazil, Bolivia, Sudan, Mexico, Colombia, Vietnam, Honduras, and Bangladesh have increased their biotech crop area and continue to allow farmers to adopt biotechnology in food production, smallholder farmers see the direct improvements this offers, allowing them to provide better lives for themselves and their families.
Developing countries now account for 53 percent of the global biotech area planted.
The ISAAA report was released in conjunction with a similar study by PG Economics, Ltd. Both studies highlight and quantify the continued social, environmental and economic benefits of the global adoption of biotechnology in agriculture.
From 1996-2016, PG Economics reported biotech crops provided $186.1 billion in economic gains to some 17 million farmers, many of whom are female, smallholder farmers solely responsible for the livelihood of their families and communities.
"Global food insecurity is a huge problem in developing countries, with around 108 million people in food crisis-affected countries still at risk or experiencing food insecurity," said Graham Brookes, Director of PG Economics and co-author of the socio-economic and environmental impact paper. "We have seen for more than 20 years now how crop biotechnology adoption in developing countries has contributed to higher yields, more secure production, and increased incomes greatly contributing to decreasing poverty, hunger and malnutrition in some regions of the globe most prone to these challenges."
The PG Economics study also shows great strides have already been made to reduce the footprint of agriculture and in mitigating and adapting to climate change. The latest study highlights how biotech use in agriculture continues to contribute to reducing greenhouse gas emissions.
Highlights from the PG Economics report include:
- In 2016, the GM crop-related carbon dioxide emission savings from reduced fuel use and additional soil carbon sequestration were equal to the removal of 16.75 million cars from the roads.
- Advances in biotech crops allow farmers to use insecticides and herbicides more strategically, reducing the environmental impact associated with their use by 18.4 percent on GM crop areas since 1996.
- In 2016, the direct global farm income benefit from GM crops was $18.2 billion, equal to an average increase in income of $102/hectare. Since 1996, farm incomes have increased by $186.1 billion.
- Biotechnology remains a strong investment for farmers. In terms of farmer investment, for each dollar invested in biotech crop seeds, farmers gained an average $3.49.
Additional highlights from ISAAA's 2017 report include:
- In 2017, 67 countries used biotech crops.
– This includes 24 countries in total that grew biotech crops, including 19 developing and five industrial countries;
– and an additional 43 non-planting countries that formally regulate the importation and use of biotech crops for food, feed and processing
- Top five countries (USA, Brazil, Argentina, Canada and India) planted 91.3 percent of the global biotech crop area of 189.8 million hectares or 469 million acres.
- Biotech crops increased ~112-fold from 1996, the fastest adopted crop technology in the world; accumulated biotech area at 2.3 billion hectares or 5.7 billion acres.
The complementary studies – PG Economics' "GM Crops: Global Socio-Economic and Environmental Impacts 1996-2016" and ISAAA's "Global Status of Commercialized Biotech/GM Crops: 2017" – examine the continued widespread adoption of global crop biotechnology, and the significant positive socio-economic and environmental impacts of this adoption by farmers and communities around the globe.
The associated two papers in the peer review journal GM Crops and Food are available, with open access, at: www.tandfonline.com/doi/full/10.1080/21645698.2018.1464866 and www.tandfonline.com/doi/full/10.1080/21645698.2018.1476792
Retailers experiment with blue lights to deter drug use
Monday, June 25, 2018
The pros and cons of using blue lights to deter drug use
Former Anti-GMO Activist: To Accept GMOs Is To Accept Science
There is no doubting that genetic engineering will be a major part of the future of food and agriculture. And even though 88 percent of scientists believe genetically engineered foods are safe, according to a Pew Center poll, and GMO farming can be more environmentally friendly, GMOs have always been met with a lot of public resistance. There is hope, however, that acceptance of GMOs will become more widespread if more people rely on the science-based evidence that supports the technology rather than baseless fear and sensationalism, writes former GMO-opponent turned proponent Mark Lynas in "Confession of an Anti-GMO Activist," which was recently published in the Wall Street Journal.
Mark Lynas
"Opposition [to GMOs] was largely inspired and led by environmentalists, who asserted that genetically modified crops and foods would cause a range of harms."
Lynas, a science writer, was once so opposed to GMOs that he would protest and lobby to get GMOs banned in stores, even going as far as destroying test fields where GMO crops were being grown and studied. Since his days as an anti-GMO activist, however, he has come to see the harms that he once thought GMOs caused were unfounded in science. Anti-GMO activism was actually doing the opposite of its intention.
"The anti-GMO campaign has deprived much of the world of a crucial, life-improving technology-and has shown the readiness of many environmentalists to ignore science when it contradicts their prejudices. That's not the example we need just now as the planet faces the very real threat of climate change.
Contrary to our initial fears, the overall impact of genetically modified crops has been to dramatically reduce the amount and toxicity of pesticides sprayed by farmers."
Opponents of GMOs often spew weak arguments, such as consumption of GM crops leads to cancer, autism or other diseases and disorders, to support their claims. As Lynas notes, however, the science rejects these claims:
"The view that GMO foods have no discernible impact on health is now the well-established consensus across the international community. It includes not just the NAS [National Academy of Sciences] but the American Medical Association, the American Association for the Advancement of Science, the U.K.'s Royal Society, the French Academy of Science, the African Academy of Sciences and numerous others."
Even so, Lynas recounts the internal struggle he faced of accepting the science in support of GMOs as it went against his prejudices. Once Lynas recalibrated his beliefs, reaffirming his convictions to science and supporting GMOs, he received backlash from the community he used to be a part of.
"I have often been attacked, especially by my onetime activist friends, for changing my mind on GMOs. But what was the alternative? To stick to a position that I knew to be false in order to avoid losing reputation? Environmentalism, perhaps more than any other philosophy, requires science. And science means that you must change your mind when the evidence changes, however inconvenient that might be."
With strong evidence that points to GMOs being perfectly safe, environmentally friendly and an overall improvement to farming, it is saddening that there is still such a huge debate surrounding GMOs. Hopefully soon, for the sake of the environment, more people realize what Mark Lynas has and come to support the science of GMOs.
Saturday, June 23, 2018
Caffeine could protect the heart by helping it make energy, mouse study finds
Friday, June 22, 2018
BIO Congratulates 2018 George Washington Carver and Rosalind Franklin Award Recipients
Each year at the BIO World Congress on Industrial Biotechnology, BIO recognizes innovators in the field of industrial biotechnology with the George Washington Carver Award for Innovation in Industrial Biotechnology and Agriculture and the Rosalind Franklin Award for Leadership in Industrial Biotechnology and Agriculture. This year BIO congratulates Dr. Sang Yup Lee, distinguished professor and dean at the KAIST Institute in South Korea, and Krysta Harden, vice president of external affairs and chief sustainability officer at Corteva AgriscienceTM (a division of DowDuPont), for winning the George Washington Carver and Rosalind Franklin Awards, respectively.
George Washington Carver Award for Innovation in Industrial Biotechnology and Agriculture
The annual George Washington Carver Award, sponsored by the Iowa Biotechnology Association, recognizes an individual who has made a significant contribution to building the biobased economy by applying industrial biotechnology to create environmentally sustainable products. It serves as a lasting memorial to the original vision of George Washington Carver, who, over a century ago, pioneered biobased products, materials and energy derived from renewable agricultural feedstocks. Industrial biotechnology is the modern-day equivalent of Carver's vision.
Dr. Lee has actively promoted the importance of industrial biotechnology through engagement with the public, policymakers and decision makers around the world. Dr. Lee has published more than 575 peer-reviewed papers, contributed to 82 books and holds 636 patents.
As BIO's Executive Vice President of Industrial and Environment Brent Erickson said: "Dr. Sang Yup Lee has advanced the biobased economy by developing innovative products and processes that are sustainable and environmentally friendly…. His contributions to the advancement of the industry are a continuation of the legacy left behind by George Washington Carver."
"The credit all goes to my research team who has worked together for the past few decades," said Dr. Lee when learning of the honor. "Industrial biotechnology is becoming increasingly important to help achieve the UN's Sustainable Development Goals. We should continue to work together to advance the field and establish a solid foundation for the sustainable future."
Rosalind Franklin Award for Leadership in Industrial Biotechnology and Agriculture
The annual Rosalind Franklin Award, sponsored by the Rosalind Franklin Society, will be presented at the same plenary session on Wednesday, July 18, at the 2018 BIO World Congress to Corteva Agriscience's Vice President of External Affairs and Chief Sustainability Officer Krysta Harden.
Named after former King's College research associate Rosalind Franklin, the award is sponsored by the Rosalind Franklin Society, whose goal is to support and showcase the careers of eminent women in science. While working as a research associate in London, Rosalind Franklin conceived and captured Photograph 51 of the "B" form of DNA. Her photograph, acquired from a machine Dr. Franklin herself refined, revealed the structure of DNA, making it the single most important advance of modern biology. Though sometimes overlooked, Rosalind Franklin's critical work and discovery in the field has allowed the biotechnology industry to become what it is today.
"Krysta was a leader when she worked in Congress and the federal government and she continues to be a leader in the private sector," said Erickson. "The combination of her advocacy in biotechnology innovation and promotion of women in the field makes her the perfect recipient for an award that aims to honor the distinguished women that work in science."
"I am humbled to receive such a prestigious award," said Krysta Harden. "As an advocate for both biotechnology and women in science, it is an honor to receive the Rosalind Franklin award. Women leaders continue to play an increasingly pivotal role in science fields. From the farm to the lab to the boardroom, there are many possibilities for women in science and we must continue to open doors for them."
Following the award ceremonies, both recipients will participate in a panel discussion moderated by Brent Erickson on Wednesday, July 18 from 11:30 AM – 1 PM to discuss how industrial biotechnology has changed over the last 15 years and highlight promising opportunities for growth in the future.
For more information about the plenary session and other programming, view the program schedule here. For more information about this year's BIO World Congress, including information about past year's award winners, click here.
And if you haven't done so yet, be sure to register to attend the 2018 BIO World Congress in Philadelphia, July 16-19, 2018.
Thursday, June 21, 2018
A Milestone for America's Patent System
USPTO Director Iancu and Secretary of Commerce Wilbur Ross sign proclamation celebrating 10 millionth patent
"Innovation has been the life blood of this country since its founding," said Secretary of Commerce Wilbur Ross earlier this week in a press release announcing the 10 millionth patent issued by the United States Patent and Trademark Office (USPTO).
Strong, reliable and enforceable patent laws are the drivers of the biotechnology innovation ecosystem. Without these strong patent rights, the financing to take revolutionary biotechnology discoveries from the lab to the patient, farmer, or consumer would be unavailable. The weakening of these patent rights threatens new investment in the innovation sector of our economy and, with it, the jobs and industries of the future.
Toady in The Hill, BIO's President and CEO Jim Greenwood addressed our industry's concerns regarding the deficiencies within the USPTO that have weakened the our patent system that have led to the U.S. Chamber of Commerce to rank our patent system as only 12th in the world, behind nations like Singapore, France, and South Korea.
Wednesday, June 20, 2018
Cold, hard cash and a fitness device could help motivate people to exercise: Study
Tuesday, June 19, 2018
GMOs Help Us Combat Global Food Security and Sustainability Challenges
Every day, farmers around the world use GMOs to help combat threats to food and the environment. Whether helping to protect crop yields against plant diseases, weeds, pests, or to reduce water use, GMOs are one of modern agriculture's many innovations that allow farmers to grow more food with fewer resources. A new blog post at the GMO Answers Medium page show exactly how:
- Research into GMO bananas could help save the crop in Africa, where is it a staple in the diet and under attack from disease
- Golden Rice, a GMO fortified rice is int,ended to address Vitamin A deficiency (VAD), a serious disease which is estimated to affect 250 million preschool-age children around the world.
- The GMO Hawaiian papaya has helped save an important industry for Hawaiians since it came to the U.S. market in 1998.
To learn more about how these GMOs are helping find solutions to food problems around the globe, visit the GMO Answers Medium page.
