Plant in Blakely, Georgia Suspected of Producing Salmonella Contaminated Peanut Butter

A peanut processing plant in Blakely, Georgia owned by The Peanut Corporation of America of Lynchburg, Va., is now the prime site under suspicion for having produced salmonella contaminated peanut butter. According to health inspection reports obtained by the New York Times from Georgia officials that indicate that the plant "has a history of sanitation lapses and was cited repeatedly in 2006 and 2007 for having dirty surfaces and grease residue and dirt buildup throughout the plant, according to health inspection reports. Inspection reports from 2008 found the plant repeatedly in violation of cleanliness standards."

The Times further reports that: "Inspections of the plant in Blakely, Ga., by the State Agriculture Department of Georgia found areas of rust that could flake into food, gaps in warehouse doors large enough for rodents to get through, unmarked spray bottles and containers and numerous violations of other practices designed to prevent food contamination."

The Atlanta Journal Constitution reports: "The plant has shut down and laid off most of its workers."

The Constitution adds that: "The salmonella outbreak has sickened 501 people in 43 states, and may be linked to eight deaths, according to the Centers for Disease Control and Prevention."

The New York Times, reporting on the Blakely, Georgia peanut plant, from details provided from inspection reports prepared by Georgia officials adds: "A typical entry from an inspection report, dated Aug. 23, 2007, said: “The food-contact surfaces of re-work kettle in the butter room department were not properly cleaned and sanitized.” Additional entries noted: “The food-contact surfaces of the bulk oil roast transfer belt ... were not properly cleaned and sanitized. The food-contact surfaces of pan without wheels in the blanching department were not properly cleaned and sanitized.”

The Times cites other violations of code obtained from inspectors that: "clean peanut butter buckets (were) stored uncovered," and a "wiping cloth" served to “cover crack on surge bin.”

The times adds that: "Two inspection reports from 2008 found the plant out of compliance with practices for making sure" and Georgia officials added that “food and non-food contact surfaces were cleanable, properly designed, constructed and used.”

Under a "contractual agreement" the Georgia Agriculture Department conducts the inspections as a representative for the U.S. Food and Drug Administration.

HooRay! FDA Approves First Clinical Trial Using Human Embryonic Stem Cells

In a major development awaited by millions of American citizens for a number of years; The United States Food and Drug Administration announced yesterday that it would now allow the very first clinical trial study to commence using the stem cells obtained from a human source.

Although the decision by the FDA comes on the heels of former-President Bush's departure from office this past Tuesday, January 20th, 2009, FDA officials were quick to point out that politics played no role in the decision. This may be the official position of the FDA, however, the agency had to be well aware that if the decision had been made while Bush was in office, it would have faced certain rejection. With Obama now president such considerations became inconsequential to FDA administrators.

The use of human embryonic stem cells holds such importance because the current use of stem cells from adult and fetal sources exhibit an inability to match the many different types of tissue produced. On the other hand, human embryonic stem cells display the rare ability to form any particular kind of cell found in the human body; making their usefulness much greater than the stem cells the Bush administration had approved for study. It is a well known fact that embryonic stem cells provide the body with the foundational building blocks needed for producing all of the blood, organs, and tissues needed to establish and maintain human life.

Geron, a Menlo Park, California-based biotechnology firm, is scheduled to begin its research using eight to ten individuals who suffer from acute types of spinal cord damage. Initially each patient will receive injections of nerve cells, derived from embryonic stem cells called oligodendrocytes, which will encase surrounding axons mending the insulation or myelin, and perhaps also prompting the damaged areas to regenerate. After the injections are made at the spinal injury site it is expected that they will conduct the transmission of electrical signals from the brain to other parts of the body.

If success is proven in the treatment of spinal cord injuries, the use of human embryonic stem cells could establish the field of regenerative medicine, which would mean that such incapacitating diseases as Alzheimer's, Parkinson's and multiple sclerosis could face a more hopeful future of treatment and possible cures.

The cells being used in this initial study represent first human embryonic stem cells ever developed. Researchers had feared those cells could never be used to treat people because they were These initial cells were created from substances collected from cows and mice. Initially researchers feared that the human immune system would reject the cells.

Unfortunately, scientists engaged in stem cell research had to deal with a number of obstacles created in 2001, when former-President Bush preempted the use of animal-free stem cell lines. Bush's decision effectively pushed any embryonic stem cell therapy at least until the end of his term in office that unfortunately lasted until January 20th, 2009. To make the observation that Bush did everything in his power to derail human embryonic stem cell research would be an accurate although unfortunate point of fact. Bush needlessly politicized the topic of stem cells in order to satisfy his most deranged 'pro-life' supporters. In other words Bush made a very stupid and research crippling decision to gain a few votes. Now with Bush out of office FDA decision makers can resume with stem cell research that is safe for humans, and the floodgates will open to allow numerous clinical trials to proceed.

There is also hope that if the initial stem cell treatments do not prove to be completely successful; they could lead to improvements in many disease-stricken and injured people's lives. Regardless of the initial results; there is a considerable amount of optimism among medical researchers and doctors that humankind may be on the verge of initiating a burgeoning era of medical therapeutics in which medical breakthroughs are made at the cellular level obviating the reliance on current pharmaceuticals and surgical implements such as scalpels. Another advantage that presents itself is the possible lowering of medical costs since the cells could be mass produced.

Whatever the case might be, Americans, indeed people around the world must maintain their patience. Advancements in proceedures involving human embryonic stem cell rsearch show tremendous promise for all of humanity. But we must remember, scientific research is a long and tedious process that does not attain progressive developments in a linear manner. Many questions confront us now and more will develop over time. Perhaps the most important development we have achieved in the last few days has been the replacement of Bush the anti-science fanatic; with President Obama, a man who has pledged his complete support for the value of science to humanity in general and his unquestioned affirmation for the supported growth of human embryonic stem cell research in particular.

Obama Faces a "Fundamentally Broken" FDA

ALICIA MUNDY and JARED A. FAVOLE, of the Wall Street Journal, write that: "A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law. The nine scientists ... say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal." The letter includes a passage that reads: "There is an atmosphere at FDA in which the honest employee fears the dishonest employee." The nine scientists focus their concerns on the scientific procedures used to review medical apparatuses that they say has been "corrupted and distorted by current FDA managers, thereby placing the American people at risk." A spokesperson for the agency has explained that the FDA is "actively engaged in a process to explore the staff members' concerns and take appropriate action." Commissioner Andrew von Eschenbach and Bill McConagha, the assistant commissioner for accountability and integrity have been contacted by the nine scientists. The Wall Street Journal reporters say: "The agency has been under fire from both parties in both Houses of Congress as being too close to industry. Several leading politicians, including Sen. Chuck Grassley have complained that FDA leaders often ignore or suppress their own scientists' opinions on safety issues involving drugs and devices. Those concerns were also aired in a report by the National Academy of Sciences' Institute of Medicine in 2006. FDA leaders, including drug division chief Janet Woodcock, have said they are working to improve the culture at the FDA, and are listening to dissent from their experts and doctors." The nine scientists have expressed their hopes that the FDA's current leaders are quickly replaced by the incoming Obama Administration. The nine scientists "says the FDA approved such devices without clinical evidence showing they were effective in detecting breast cancer. Since 2006, FDA physicians and scientists have recommended five times that these devices not be approved without valid scientific and clinical evidence. The group said there needs to be a complete restructuring of the evaluation and approval process, and that Mr. Obama needs to sign new legislation giving protection to government employees who speak out against corruption." The untenable situation at the FDA reflects poorly on the conduct of the Bush Administration when it comes to oversight of FDA procedures regarding medical devices. The most important of several questions looming over the FDA's disregard for established scientific procedures is whether the actions of the leadership were intentional or a matter of gross misconduct.