[News & Analysis] Intellectual Property: California Moves Shake Up Prenatal Gene Testing Market

Science 8 November 2013:
Vol. 342 no. 6159 p. 680
DOI: 10.1126/science.342.6159.680 Intellectual Property Sequenom's 2001 patent on a method of isolating fetal DNA from a mother's bloodstream to test for Down syndrome was thrown out by a U.S. court in San Francisco. Judge Susan Illston rested her decision in part on the recent Supreme Court ruling that natural phenomena like genes cannot be patented. Illston also wrote that Sequenom's patented idea was not sufficiently inventive.

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Hawaii's Kauai Island moves to curb gene-altered crops, pesticide testing

By Christopher D'Angelo

Lihue, Hawaii | Wed Oct 16, 2013 11:18am EDT

Lihue, Hawaii (Reuters) - Lawmakers on the tropical island of Kauai, Hawaii, on Wednesday approved a hotly contested measure aimed at reining in widespread pesticide use by companies testing new genetically modified crops on the island.

The Kauai County Council passed the bill by a vote of six to one after months of protests by islanders and mainland U.S. groups who wanted to see a range of broad controls on the global agrichemical companies that have found the island's tropical climate ideal for year-round testing of new biotech crops.

The vote on Kauai came amid a global backlash against the spread of genetically-modified organisms in food and feed(GMO). Critics claim they contribute to greater pesticide use, environmental damage and health concerns for people and animals. But the industry says they are crucial for increasing global food production and improving environmental sustainability.

"This victory is an amazing credit to the people of Kauai who stood up to massive pressure from the GMO companies and won their right to know about pesticides and GMOs in their community," said Charles Margulis, a spokesman for the California-based Center for Environmental Health, which supported the bill.

Known as Hawaii's "Garden Isle," Kauai's landscape has become fertile ground for testing of new crops by DuPont Pioneer, Syngenta, BASF, and Dow AgroSciences, which together have staked out work on an estimated 15,000 acres on the isolated Hawaiian island.

DuPont, which fought to defeat the bill, was disappointed it passed, and may sue to block its implementation, said spokesman Josh St. Peters.

"We believe it to be bad policy - and the kind of regulation that should remain at the state and federal level, where policy makers and agencies are already empowered with oversight of our industry," he said. "We believe that the bill is not legally defensible and we continue to evaluate all of our business and legal options."

Kauai is the fourth largest of the main Hawaiian Islands and has a land area of 562.3 square miles and a population of about 67,000.

Many on the island have blamed health problems and pollution on what they say is excessive use of pesticides as the companies test a range of genetically altered crops. In early September, more than 3,000 islanders took to the streets of Lihue with signs and banners, and chanting "Pass the Bill."

More than 80 people lined up to offer testimony to the council meeting, which started on Tuesday morning but lasted until 3:30 a.m. local time on Wednesday. Only four people testified against the bill, the rest asked for its passage.

Early versions of the measure introduced in June prohibited open-air testing of experimental pesticides and genetically modified crops, established a permitting process for the industry and placed a temporary moratorium on the expansion of GMO crop test fields.

"The people in my community have asked for help," Kauai County Councilman Gary Hooser, who introduced the bill, said on Tuesday. "People are concerned."

In an attempt to forge compromise last month, Hawaii Gov. Neil Abercrombie proposed that pesticide and genetically engineered seed corporations be allowed to voluntarily disclose pesticide use.

The version of the bill that passed late Tuesday was stripped of some of its tougher conditions and now requires the agricultural companies to disclose the presence and use of genetically modified crops and pesticides; establishes buffer zones around schools, hospitals, homes and other areas, and requires the county to conduct a study on the health and environmental impacts of the industry.

Concerns about pesticide use on the island have been mounting in recent years and some allege health problems, including increased rates of cancer, are tied to the farm chemicals on the experimental crop fields.

But testifying at the hearing, BASF representative Kirby Kester said that passage of the bill was unwarranted because there is no evidence the companies are doing any harm.

And prior to the meeting, Mark Phillipson, spokesman for Syngenta Hawaii, said the industry was committed to a safe environment.

"We abide by high standards to create a safe environment for our workers, our neighbors and the community," Phillipson said.

A spokesman for Dow could not immediately be reached for comment.

(Reporting and writing by Carey Gillam in Kansas City and reporting by Christopher D'Angelo in Kauai; Editing by Alden Bentley)

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NEW: Cholera: Diagnosis and Testing in Haiti

Laboratory Test Results of Cholera Outbreak Strain in Haiti Announced

Growth of V. cholerae on thiosulphate citrate bile salt sucrose agar  (TCBS)
Photo Credit: Centers for Disease Control and Prevention Atlanta, Georgia 1999

Culture: Vibrio cholerae (V. cholerae) is confirmed through culture from stool or rectal swabs. For isolation and identification, a selective medium, thiosulfate citrate bile salts (TCBS) agar is used and the serogroup and serotype is confirmed using V. cholerae specific antisera.

Antibiotic Susceptibility Testing: Many bacteria, including V.  cholerae, show resistance to some antibiotics used to treat illnesses. It is important for clinicians to understand what drugs various bacteria are typically resistant to in order to prescribe effective treatment regimens. In addition, related bacteria usually show similar resistance patterns. Bacterial drug resistance can be tested in the laboratory. Bacteria are exposed to various concentrations of multiple antibiotics. Bacteria that grow are considered resistant whereas bacteria that do not grow are considered susceptible.

Antibiotic susceptibility testing requires several days to perform. Antibiotic susceptibility testing of selected isolates provides information that helps inform recommended antibiotic therapy for treating a population. However, it is not recommended for guiding care for individual patients.

The V. cholerae isolates from people with cholera in Haiti have undergone antimicrobial susceptibility testing.

Scanning electron micrograph of V. cholerae bacteria
Photo Credit: Centers for Disease Control and Prevention Atlanta, Georgia 2005

Current antibiotic testing results show*:

*Susceptibility testing of selected isolates from ill patients in Haiti will continue, and clinicians should be alert for changes in antibiotic treatment recommendations based on clinical experience in Haiti.
**Susceptibility inferred based on tetracycline testing.

Rapid Tests:  Commercially available rapid immunochromatographic test kits for stool antigen are useful in epidemic settings but do not yield an isolate for antimicrobial susceptibility testing and subtyping, and should not be used for routine diagnosis.

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Study of recalled medical devices faults lax FDA testing methods

A new analysis is raising questions about how good a job the Food and Drug Administration is doing at protecting Americans from faulty medical devices.

Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives. Most of the devices - 71 percent - had been approved without undergoing testing in people, the researchers reported Monday in the Archives of Internal Medicine.

That's because under a process designed to get products on the market as soon as possible, they were deemed to be similar to another product already being sold. Only 19 percent underwent more stringent review.

"Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy," wrote Diana M. Zuckerman of the National Research Center for Women & Families in Washington, D.C., and Steven E. Nissen of the Cleveland Clinic in Cleveland.

One-third of the recalled devices were for heart disease, including automatic external defibrillators, or AEDs. Those are the gadgets that have been increasingly showing up in airports, office buildings and other public places that shock the hearts of people who suffer sudden cardiac arrest. Defective AEDs reportedly have resulted in hundreds of patient deaths, the researchers said.

The findings indicate that the agency is allowing too many medical devices onto the market using the less stringent approval process, the researchers said.

"The FDA is now using the . . . process for 98 percent of the medical devices that they review, including heart valves, glucose meters and artificial hips and knees," Zuckerman said in a statement released with the report. "We think patients will be shocked to learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work."

Nissen said the findings should be a "wake-up call" to the agency and doctors.

Officials at the FDA, however, dismissed the findings, saying that it was not surprising that most of the recalls involved devices approved through the accelerated process since most of the devices on the market were approved that way.

"Even one recall is too many," said FDA spokeswoman Karen Riley in an e-mail. "But, considering that more than 19,000 devices were cleared via the ... process between 2005 and 2009, it's important to keep the 80 recalls in perspective. They represent a small numbers of the devices cleared via this program and don't reflect the thousands of people who have benefited from these devices."

Riley noted that the agency had recently completed a review of the program and was making 25 changes designed to make the approval process even safer.

In an editorial accompanying the study, Rita Redberg, editor-in-chief of the journal, agreed the findings indicate the need to improve safeguards.

"Doing the right thing will require withstanding the pressure of industry lobbyists," she wrote. "Without any data to support their statements, the lobbyists suggest that the proposed FDA changes--which could improve public safety--will 'chill device development.'"

Officials representing the medical device industry also dismissed the findings. The big problem with the FDA's medical device review process is that it is too slow, a trade group officials said. Many products, including those made in the United States, routinely become available in Europe years before they are approved in this country, he said.

"The real problem at FDA is not that they are clearing unsafe devices. They are doing a very good job of making sure devices are safe and are taking steps to make the process even better," said David Nexon, senior vice president at AvaMed, the industry's trade group. "The bigger problem is the efficiency and consistency of the process deteriorated so dramatically in recent years."

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