By BRETT J. BLACKLEDGE
Associated Press Writer

WASHINGTON (AP) — A peanut processing plant in Texas run by the same company blamed for a national salmonella outbreak operated for years uninspected and unlicensed by government health officials, The Associated Press has learned.

The Peanut Corp. of America plant in Plainview never was inspected until after the company fell under investigation by the U.S. Food and Drug Administration, according to Texas health records obtained by AP.

Once inspectors learned about the Texas plant, they found no sign of salmonella there. But new details about that plant — including how it could have operated unlicensed for nearly four years — raise questions about the adequacy of government efforts to keep the nation’s food supply safe. Texas is among states where the FDA relies on state inspectors to oversee food safety.

The salmonella outbreak was traced to the company’s sister plant in Blakely, Ga., where inspectors found roaches, mold, a leaking roof and internal records of more than a dozen positive tests for salmonella.

The outbreak so far has resulted in more than 500 reported illnesses, led to an expansive recall and caused as many as eight deaths. The government is working on a criminal investigation in the case.

In Texas, inspector Patrick Moore of the Department of State Health Services was sent to Plainview, in the sparsely populated Texas Panhandle, after salmonella was traced to the company’s plant in Georgia. Moore said the Texas plant wasn’t licensed with health officials and had never been inspected since it opened in March 2005. Texas requires food manufacturers to be licensed every two years and routinely inspected.

“I was not aware this plant was in operation and did not know (what) type of products processed,” Moore wrote in an inspection report obtained by AP.

The plant is registered with the Texas Comptroller of Public Accounts to do business as Plainview Peanut Co. LLC, according to state records. But the company “was unable to present evidence at the time of the inspection of a current food manufacturers license,” Moore wrote in his report.

The plant was properly registered with the FDA as a food processing plant, said David Glasgow, director of the agency’s investigations branch in Dallas. FDA inspectors went through the plant two weeks ago after the state inspection and did not find salmonella or other problems, Glasgow said.

Texas ordered its inspection Jan. 12 during the FDA’s investigation of the Georgia plant, after it received reports that Peanut Corp. was operating the plant in Plainview, health services spokesman Doug McBride said. Texas requires food companies to obtain two-year licenses but doesn’t have enough money or inspectors to catch companies that don’t.

“We can’t drive up and down the street to know what people are doing behind closed doors,” McBride said.

Moore reported some unsanitary conditions, such as unclean sections of a peanut roasting line. But several internal company laboratory tests dating back to November found no salmonella or other contaminants, according to documents included in Moore’s report.

Plant manager Jesus Garrocho told Moore that he sent Texas health department forms to the company’s Virginia headquarters more than a year ago and did not know why the licensing forms were not completed.

Moore said the plant manager promised during the January inspection to register the plant with state health officials: “He will make sure this gets in and paid,” Moore wrote.

McBride said the company still hasn’t done so.

“Our first preference is not to go out and shut somebody down and wipe out jobs and income,” he said. “Our philosophy in any of our regulatory programs is to try to get a company in compliance.”

The plant is the subject of a complaint filed since the state’s inspection Jan. 12, and is scheduled for a new inspection in coming weeks, McBride said. He would not provide details about the complaint.

Garrocho referred questions Monday to company lawyers. Amy Rotenberg, a Minneapolis lawyer representing Peanut Corp., declined to comment.

The Texas plant blanches, dry roasts, oil-roasts and chops peanuts, then ships them to food companies across the country. The Georgia plant also processes peanuts, and produces peanut paste and peanut butter.

Copyright 2009 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the scientists wrote.

FDA spokeswoman Judy Leon said in response: “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency’s reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.

A spokeswoman said the Obama transition team had no comment.

Copyright 2009 The Associated Press.

WASHINGTON (AP) _ Treatment with certain epilepsy drugs may expose some Asian patients to serious skin reactions, federal health officials warned Monday.

The Food and Drug Administration said it is investigating whether medications like Dilantin, Phenytek and Cerebyx, which are used to control epileptic seizures, can lead to severe skin blisters and bleeding for some Asian patients.

Patients who test positive for a gene known as HLA-B1502 appear to be at increased risk of developing the skin problems, preliminary data indicate. About 10 percent to 15 percent of patients from parts of China, Thailand, Malaysia, Indonesia and the Philippines may carry the gene, as do 2 percent to 4 percent of South Asians, including Indians.

The FDA urged doctors to monitor patients closely, but said there is not enough information yet to recommend genetic testing. In most cases, patients who develop the skin problems do so in the first few months after starting to take the medications.

Because of the problem with skin reactions, the FDA last year recommended genetic testing for Asian patients taking another epilepsy drug, carbamazepine, sold under several brand names including Tegretol and Carbatrol. Doctors should also avoid Dilantin and the other medications for patients who have already tested positive for the gene, the FDA said.

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On the Net:

FDA safety alert: http://tinyurl.com/5fcnlf

Copyright 2008 The Associated Press.

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ Hundreds of thousands of baby boomer women who think they’ve found an antidote to aging in cosmetic facial fillers must be better informed of possible risks, government health advisers said Tuesday.

A panel of independent advisers urged the Food and Drug Administration to revise the labeling to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars.

“It is almost a no-brainer,” said Dr. Michael Bigby, a Harvard Medical School dermatologist. “The current label is not adequate.” The gel-like fillers, which have become hugely popular in the last few years, are injected into the face to smooth away wrinkles.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But Tuesday’s FDA hearing raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The hearing was a first step as the FDA considers whether to regulate fillers more closely.

Plastic surgeons pledged to help the government track safety, improve training and provide clearer information to consumers.

Women, and even some men, are drawn to skin fillers by the promise of youthful good looks at far less cost and trouble than a face lift. A touchup two or three times a year can boost deflated middle-age egos. Unfortunately, for some patients, the result can be blotchy skin, bumps on the face and worse.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle, except they’re injected into the face. They include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested and approved for, such as plumping the lips, which are extremely sensitive.

There are also questions about a lack of clinical evidence on how darker-skinned patients fare with the beauty treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications from fillers.

“The trouble is that once this material is in the hands of physicians, there’s really not much control over how it’s used and where it’s placed,” said Dr. Scott Spear, a Washington plastic surgeon. “That creates the potential for a certain amount of mischief.

“But the good news is that, by and large, these are very safe materials,” Spear added. “They have a very healthy risk profile.”

FDA scientists will present the advisory panel with data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. The overwhelming majority were women, and the most common age group was 50- to 60-year-olds. Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

Although no deaths were reported to the FDA, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

Most reactions involved minor swelling and redness, complications that could be expected. But the FDA said it also received reports of “serious and unexpected” problems, including facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions.

A small number of patients — 19 — went to the emergency room with life-threatening allergic reactions, such as difficulty breathing. Twelve developed infections that required hospitalization.

“The FDA has been rushing these products to market as if they were lifesaving medical products,” said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families. “They should be requiring better studies since these products have only cosmetic benefits but potentially lethal risks.”

Some problems reported to the FDA may be due to unapproved or “off-label” use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.

Another challenge is the sheer variety of fillers. Most are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not. That means they may react differently in the body.

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On the Net:

Food and Drug Administration: http://tinyurl.com/5jtuxv

Copyright 2008 The Associated Press.