Good Day BIO: Regulatory uncertainty hurts efforts to feed the world

Biotech can help feed the world—but regulatory uncertainty is thwarting the effort, says BIO’s Dr. Michelle McMurry-Heath. Plus, late-stage cervical cancer sees an unnecessary upward trend. (738 words, 3 minutes, 41 seconds) 

P.S. BIO’s Michele Oshman interviews Rep. Buddy Carter (R-GA) about how federal policies affect patients during Georgia Bio’s Patient Advocacy Summit today—get the details and register.

BIO CEO: Regulatory uncertainty hurts efforts to feed the world

As drought threatens our food supply, biotech has solutions ready to go—but we need clear regulations that encourage innovative development, BIO President and CEO Dr. Michelle McMurry-Heath writes in Agri-Pulse.

The challenge: USDA’s Drought Monitor shows drought is impacting areas of the country that produce wheat, beef, dairy, barley, alfalfa, and hay, writes Dr. Michelle McMurry-Heath. Meanwhile, climate change and the war in Ukraine are harming global food supply.

Biotech offers solutions: “companies like Bayer CropScience are developing corn and rice hybrids that are more resilient to drought,” she notes. “Corteva Agriscience and BASF are developing the next generation of soybeans resistant to pests.” Acceligen breeds heat-tolerant cattle, and J.R. Simplot Co. makes crops that keep better, reducing food waste.

But biotech needs support—a “clear, science-based, and efficient regulatory system. Unfortunately, the U.S. government has fallen behind in developing policy on biotechnology and gene editing.” 

Specifically:

• FDA’s draft guidance on the use of biotech in animals is delayed, as BIO told the Office of Management and Budget.
• Funding has been proposed but not appropriated for FDA guidance on new plant varieties.
• USDA’s recent regulatory frameworks for biotech plants needs further updating.
• EPA has yet to issue final rules on plant-incorporated protectants. 

And other countries must step up—including Mexico, whose “non-science-based” approach stymies the development of technologies that can sustainably feed the world, Dr. Michelle explains.

The bottom line: “Agriculture and science are moving rapidly to meet food demand and adapt to a changing climate,” says Dr. McMurry-Heath. “We need practical, workable government regulations, both in the U.S. and abroad, to strengthen food security through innovation.” 

Read the whole thing.

Learn more about biotech solutions for agriculture.

Late-stage cervical cancer has unnecessary upward trend

In the United States, Black women are more likely to be diagnosed with the most advanced cervical cancers, and the rate of occurrence in all women is growing—even though we can prevent many cervical cancers.

Late-stage cervical cancer is rare: From 2001-18, some 29,715 women were diagnosed with late-stage cervical cancer, with cancer spreading to other organs, says a study published last week in the International Journal of Gynecologic Cancer. It has a five-year survival rate of only 17%.

While cervical cancer is declining overall, late-stage diagnoses are up—about 1.3% per year, according to the study.  

In the U.S., Black women had higher incidence of late-stage cervical cancer, at 1.55/100,000 versus 0.92/100,000 for white women. However, white women in the South ages 40-44 had the highest increase at 4.5% annually. White women are also more likely to miss screenings and white teenagers had lower rates of HPV vaccination (66.1% versus 75.3% for others), finds the study.

Cervical cancer should be rarer: More than 90% of anal and cervical cancers are caused by human papillomavirus (HPV)—but since 2006, we’ve had an effective HPV vaccine, BIO member Merck’s Gardasil.

The UK has almost eliminated cervical cancer among women born after 1995, thanks to a rigorous vaccination campaign, but in the United States, the HPV vaccine is only required in a few states.

Early detection is critical: HPV tests and pap smears can catch cervical cancer early, says the American Cancer Society, and the prognosis can be greatly improved with treatments, including the new Tivdak.

Thanks to biotech,we have the tools to make cervical cancer a thing of the past—we just need to use them. 

More Reading:

• Rwanda fights cervical cancer with information
• WHO: One dose of HPV vaccine gives solid protection against cervical cancer

The Washington Post: Fauci plans to step down in December after half a century in government
“Anthony S. Fauci, the nation’s preeminent infectious-disease expert who achieved unprecedented fame while enduring withering political attacks as the face of the coronavirus pandemic response under two presidents, plans to step down in December after more than a half-century of public service, he announced Monday.” 

Pfizer: Pfizer and BioNTech seek FDA authorization for booster targeting Omicron BA.4/BA.5
“Pfizer Inc. and BioNTech SE [yesterday] announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.”

P.S. Don't miss two important virtual events today:

• Georgia Bio Patient Advocacy Summit, featuring BIO's Michele Oshman interviewing Rep. Buddy Carter (R-GA)—get the details and register. The event takes place from 11 AM to 1 PM ET.
• BlackDoctor.org's Protecting Our Kids: The Truth About Vaccinations and Immunizations—watch on YouTube or Facebook at 3 PM ET.

President Biden’s Tuesday: Continuing summer vacation.

What’s Happening on Capitol Hill: Recess.