CUERO, Texas -- The Food and Drug Administration has launched an investigation into a mysterious medicine that was tested on patients in several small towns southwest of Houston, Local 2 Investigates reported Thursday.

The federal investigation centers around a complaint filed by a nurse anesthetist who reported that he witnessed the unapproved drug being given to patients without their knowledge or consent.

With a hidden camera, Local 2 Investigates found the drug stocked in the pharmacy at Cuero Community Hospital, the only hospital in a small Dewitt County town. The pharmacist quickly jerked the medicine away, apparently thinking a KPRC undercover reporter was actually a potential patient getting too close a look at the medicine container.

The drug is called Providex. It has also been marketed and sold under the names "Sore Relief" and "Durable Closure."

The former nurse who reported the testing on humans, Timothy Goosby, said, "If people in that town knew that if they received that medication, that they were being tested on, that they were becoming -- as you say -- guinea pigs -- I think you might find a great public outcry."

Goosby first complained to the Cuero Community Hospital CEO. He then filed complaints with the FDA, the FBI, several state legislators and state regulatory boards.

In some cases, Goosby reported he was present as the medicine was rubbed on cuts and sores of patients at Cuero Community Hospital. In one case, he said the medicine was actually injected into the abdomen of a patient who had just undergone intestinal surgery.

"When I saw him inject it into the patient's abdomen, I was absolutely appalled," Goosby said.

He reported to the FDA that several of his colleagues were concerned about the fact that patients had no idea that an experimental, unapproved drug was being tested on them. His complaint likened it to the infamous Tuskegee Study of the 1930s, when the government experimented with a new syphilis medicine on hundreds of black men without telling them.

In the Texas case, he said the only difference is a physician who stands to profit.

"He had a great financial involvement. I don't think the Tuskegee people had financial gain," Goosby said.

The CEO of Cuero Community Hospital when "Providex" first arrived, Jim Buckner, admitted he purchased the drug and stocked the hospital's pharmacy for use on patients, having no idea what was in the drug.

"The product was touted to us as having been done and researched," said Buckner, who is now CEO of a different Texas hospital.

Buckner had access to all patient files when he was alerted to the testing and he told KPRC Local 2 Investigates, "If there was ever a written consent given to a patient to accept the use of this drug, I am completely unaware. I don't think we did at our hospital."

"No consents," said Goosby, who said he was forced out of the hospital for reporting the testing. He said patients were misled into believing they were receiving their usual medicine.

"It was just, 'Hello Mrs. so and so. I have your medication for you," he said. "That's the way it was being handled, that this is kind of standard protocol, this is one of the medications we use daily."

Barbershop owner Pat Flores lives near the Cuero Community Hospital and he reacted, "I don't think it's right. It's very wrong, because no telling what the consequences to those people or the side effects."

The former CEO said he bought the drugs for his hospital pharmacy in Cuero after hearing a sales pitch from one of his "influential physicians."

Dr. Daniel Dugi referred to himself as the drug company's "principal investigator," a point emphasized in an elaborate sales packet that Dugi provided to Local 2 Investigates.

Former CEO Buckner said, "When I asked him what was in this product as the active ingredient, he wouldn't disclose it, (saying) 'It's still patent pending, waiting for FDA approval,' and they couldn't share that information with us."

In the promotional literature provided to Local 2 Investigates, Dugi wrote that he had treated "well over 1000 patients" and he reported "a superior success rate" in over 90 percent of the patients he treated.

The sales pamphlet then contains 18 separate entries marked "Case Summary," spelling out how the drug performed when applied to those patients' wounds. Some of the documents are marked, "Confidential," but Dugi admitted to KPRC Local 2 that they were all his patients. Photographs and graphs illustrate the healing of the various wounds.

When KPRC Local 2 Investigates approached Dugi for answers, he invited the camera crew into a back room at one of his clinics, but he said very little.

"No filming! No filming!" Dugi said.

He insisted that the medicine manufacturer would not allow him to answer questions. When asked why a drug company should dictate his silence when talking about his own care to patients, Dr. Dugi said, "my care meets very, very good standards.

"I had informed consent from everybody that we used the product on," Dugi said when asked about whether patients knew they were subjects in a test.

He declined to answer when he was asked whether FDA knew he was testing the drug on patients.

"You're barking up the wrong tree," he said. "This is an FDA registered product."

However, the Food and Drug Administration told Local 2 Investigates it has never heard of the drug and no human testing was ever approved.

FDA spokeswoman Rita Chapelle said, "We don't comment on pending investigations."

The drug container photographed by hidden camera, along with the promotional packet for the drug, both list a National Drug Control number, or NDC number. The promotional material has "FDA Registered" typed next to the NDC number. However, when Local 2 Investigates entered that number, the drug name and the drug's ingredients into the FDA national database of approved drugs, there were no matches.

Chapelle said by telephone that she checked with several different divisions within the FDA and she found that the number did not exist.

Buckner said, "Nobody really wanted to do much about trying to stop him because he was a very influential physician on our staff."

Buckner said he left that position, partly because of the dispute over this drug.

The pharmacist in charge when the drug was first added to the "formulary," or list of medicines being dispensed to patients by the hospital, has now been elevated to CEO of Cuero Community Hospital.

Darryl Stefka, Cuero Community Hospital's current CEO declined to answer questions on camera, but he insisted the drug's use was "very legitimate." When asked whether it was tested on patients without their knowledge, he answered, "I'm sure they knew."

He was asked why the hospital would stock a drug that is not approved by the FDA, but he did not answer. He said the medicine was not used as part of a trial.

Federal law requires specific, written consent forms for any trial of a new medicine on human subjects. The doctor declined to provide verifiable proof that any such forms existed.

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