Survey Shows Alarming Amount Of Political Influence Over Food Safety

By AJ Swartwood - Talk Radio News Service

A new survey conducted by the Union of Concerned Scientists (UCS) shows that political interference in scientific work of the food and drug industries is high. The survey, which consisted of 44 multiple-choice questions and two essays, was sent to about 8,000 employees of the Food & Drug Administration (FDA) and the United States Drug Administration (USDA). 

According to the report, “The reported levels of political and corporate interference both at the USDA and FDA are troublingly high.”

Of 1,710 respondents, 238 (23 percent) reported that they had received requests from agency decision makers to “inappropriately exclude or alter technical information or conclusions in an agency scientific document.”

The topic of food safety has returned to the public spotlight once again after the recall last month of shell eggs due to Salmonella contamination. Roughly 76 million Americans suffer annually from foodborne illnesses each year, a statistic that has caused many to push for tighter regulation and more progress in the food technology and safety industry. The UCS is among certain groups that are urging the federal government to reform the industry.

“We are at a moment where the administration can act decisively by creating a Scientific Integrity Plan,” said Francesca Grifo, director of the Scientific Integrity Program at UCS. 

Though some small improvements have been made sine the last UCS survey was conducted in 2006, the UCS is calling on the government to play a greater role. Specifically, the group would like Congress to pass bipartisan food safety legislation that would enact many of the needed reforms highlighted by the recent survey.

Majority Of Oil Lingering In The Gulf

A panel of officials from the Food and Drug Adminstration (FDA), Environmental Protection Agency (EPA) and National Oceanic and Atmospheric Administration (NOAA) revealed to Rep. Edward Markey (R-Mass.), the lone member of the House Energy and Commerce Committee in attendance, some rather “unsavory” numbers regarding the status of the Gulf Coast.

After the release of the oil budget report, Markey told the panel that Americans are reacting to the Gulf Coast situation with a “false sense of confidence.”

“Over confidence breeds complacency and complacency is what got us into this situation in the first place,” Merkey said.

Dr. Bill Lehr, Senior Scientist at NOAA, estimated that nearly 4.1 million barrels of oil spewed into the Gulf of Mexico, omitting the nearly 800,000 barrels that were captured by containment efforts, but admits a majority of the oil is still present in the environment.

“Probably about three-fourths would still be [in the environment],” Lehr said.

The NOAA scientist pointed out discrepencies in his estimate saying that the only oil “officially” removed from the Gulf waters was that that was burned and skimmed. Oil contained using dispersants and that washed up on the Gulf shores as tar balls remain “in” the environment and Lehr said do not contribute to the percentages of oil removed from the water.

Lehr said that just over 10% of the 4.1 million barrels that spilled into the Gulf have been “removed” from the envorinment, leaving nearly 90% subject to dispersants, beach clean-up crews and natural dispersion.

FCC, FDA Partner Up

Philip Bunnell - Talk Radio News Service

The Federal Communications Commission (FCC) and the Food and Drug Administration (FDA) held a joint meeting Monday to announce “an unprecedented FCC, FDA partnership,” and the importance of wireless technology being used to improve healthcare and streamlined inter-agency communication.

FCC Chairman Julius Genachowski said that he hopes government can work smartly with industry to “create conditions that encourage the development of cutting edge and life saving technology,” such as the human genome project. Genachowski said that bringing broadband and wireless technology to healthcare would reduce costs, help diagnose diseases faster and, ultimately, save lives.

FDA Commissioner Margaret Hamburg emphasized that the “benefits of wireless technology to healthcare [are] very clear.”  Hamburg was very complementary of the new FCC/FDA partnership, saying that, coupled with broadband and wireless technology, it could “shift the paradigm, and will eventually change the face of medicine forever.”

The FCC and FDA will have another joint meeting Tuesday, July 27, to further discuss life-saving wireless medical technology.

New Study Shows FDA Regulations Are Hurting Patients

By Linn Grubbstrom - Talk Radio News Service

The Food and Drug Administration's (FDA) regulations have caused delays in the development of new drugs, costing patients far more than they cost producers. This is the result of a report presented by Tomas Philipson, Ph.D. of the University of Chicago and Eric Sun, M.D., Ph.D. of Stanford University.

"The main costs of drug delays to producers are not the clinical trial process being long and costly. The main cost to them is the forgone profits of delayed sales," said Philipson. "The second costs that have been ignored is the cost of patients that are waiting for these drugs to go on the market."

The study looked at the economic and health related consequences FDA regulations have for patients suffering from HIV, breast cancer and non-Hodgkin's lymphoma. In the first case, results showed that access in the market would be worth $16,000 for each patient and the total value for these patients would be $19 billion. These are all costs that can be slashed, according to the authors.

"In our report, we list a few policy recommendations such that make it easier to recruit patients into clinical trials, using bio markers to track a drug's effectiveness opposed to clinical outcome," said Sun.

The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and authorizes the FDA to collect fees from companies that produce certain human drug and biological products.

Senate Looks To HELP Those Hurt By Defective Medical Devices

By Courtney Ann Jackson - Talk Radio News Service

Members of the Senate want to ensure that medical devices which patients rely on to stay alive and healthy are working properly. Patients as well as medical professionals testified before the Senate Health, Education, Labor and Pensions Committee (HELP) Tuesday to express support for the Medical Device Safety Act of 2009.

Each witness provided different insight into an issue that Sen. Ted Kennedy (D-Mass.) sought to address over 30 years ago. He worked on the Medical Device Amendments Act, a bill that gave the Food and Drug Administration (FDA) authority to regulate medical devices.

Sen. Tom Harkin (D-Iowa) said last year’s Supreme Court decision in Reigel v. Medtronic, Inc., gave corporations immunity from lawsuits which involve endangering consumers with unsafe devices.

“The upshot is that negligent corporations are not held accountable, victims cannot receive fair compensation and consumers are at risk. Unfortunately, this has had catastrophic consequences for ordinary Americans,” said Harkin.

Michael Mulvihill was one of the patients who testified. He received 22 electric shocks within a span of 53 minutes from a faulty Medtronic defibrillator. The defibrillator had been implanted in him a little over a year ago to help address an irregular heart beat and pulse rate.

Mulvihill said, “My hope is that no one else ever has to go through the pain and agony that I experienced with the fractured lead, and that Medtronic is held responsible for the injuries it has caused other patients like me.”

Sen. Harkin believes people should maintain the ability to sue when injured and, in turn, encourage manufacturers to use “utmost care” and improve the safety of their devices.

“The threat of [product] liability is the safety net that helps repair problems when the FDA or manufacturers fail to warn consumers properly,” said Harkin.

Other members of the panel felt that the “Medical Device Safety Act of 2009” could stifle some important progress in the realm of innovation.

Michael Roman, an amputee, testified that in the time span of just five years, the changes in spinal cord stimulator technology have made a “huge difference” in his life and that of his family.

“But what if Congress had enacted the Medical Device Safety Act in 2001? For me, I’m sure it would have been game over,” said Roman.

Committee members say the purpose of the Act is to ensure the safety of consumers.