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Drug Removed From Market After Local 2 Investigates Report

By Stephen Dean

POSTED: Thursday, February 21, 2008
UPDATED: 8:10 am CST February 21, 2008

Drugs have been removed from the market nationwide as part of Food and Drug Administration action that was prompted by a series of Local 2 Investigates reports on human drug testing.

The Activ Group's Web site had offered its drugs, "Durable Closure" or "Providex," for sale on its Web site, which proclaimed, "some 'Rules were meant to be broken' and that's just what we did."

Local 2 Investigates found those drugs being stocked in the Cuero Community Hospital pharmacy, just northwest of Victoria, Texas, as a former nurse reported to the FDA and other agencies that the unapproved drugs were being tested on unsuspecting patients throughout south Texas.

The FDA told Local 2 Investigates it had never heard of the drugs and had never approved any testing on humans. The FDA and other federal officials now report the drug maker agreed to pull it from the market as part of the growing federal investigation.

Former Cuero Community Hospital Chief Executive Officer Jim Buckner said he is unaware of any patient being harmed, but he had concerns about the testing years ago when he was at the helm of the publicly funded hospital.

"It's not that we shouldn't do testing on human subjects," he said. "It should be done according to proper technique and subject to academic review."

Buckner said he never saw any written consent forms that are required by the FDA.

The drugs were administered by a Cuero Hospital physician, Dr. Daniel Dugi, who referred to himself as the "principal investigator" for the drug company. He admitted that he was an investor in the company.

"He was keeping data and research at his clinic," said Buckner. "I know he used it on patients at our hospital on a regular basis."

Attorneys for the drug company and the taxpayer-funded Cuero Hospital Board insist no testing was conducted on patients, but Dugi listed a "case summary" along with photographs of some of his patients in the drug company's marketing brochure that he provided to Local 2 Investigates. He wrote about "superior success" with "over 1,000 patients."

In an earlier broadcast, Dugi declined to answer questions about his use of the drug, saying, "It's FDA registered, which is what has to be done."

Federal officials said the drug was removed from the company's Web site and the Cuero Hospital's pharmacy, but hospital board members did not return calls for comment about that move.

The drugs in question were sold with the words "FDA Registered" and listing an NDC number, which is a serial number the FDA issues to all drugs that are approved. FDA officials told Local 2 Investigates they had never heard of the drugs and the NDC number was not on file in the FDA's registry of all NDC numbers.

CRNA (nurse anesthetist) Timothy Goosby reported to the FDA, the FBI and the Texas Medical Board that he witnessed the unapproved drug being tested on patients' wounds and sores without their knowledge or permission when he was employed at Cuero Hospital.

Lawyers for the drug company insist the firm followed all FDA rules and they did nothing wrong. The company claimed it has documents to prove it, but when Local 2 Investigates asked to review copies of those documents, the company did not reply.

The FDA declined to comment on the status of its investigation, and the U.S. Attorney's Office for the Southern District of Texas declined to comment after issuing a subpoena to gather evidence as part of a criminal investigation.

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