In what appears to be an unprecedented move, the FDA issued a second official Warning Letter, which it released yesterday, telling the primate testing lab that the agency would recommend rejecting any studies submitted to the FDA for a marketing or research permit that were performed at Coulston since December 22, 1999, as well as future such studies, as long as the widespread and fundamental Good Laboratory Practice (GLP) violations remain uncorrected.

The FDA first identified hundreds of GLP violations at Coulston during an August 1999 audit, and issued its first Warning Letter to Coulston in December of that year. The latest Warning letter specifies that Coulston remains in violation of those GLP regulations, which exist to ensure human safety and data integrity. In its strongest warning yet, the FDA threatened the lab with disqualification if the fundamental deficiencies - now more than two years old - are not corrected "promptly."

The latest Warning Letter was issued after a devastating December 2000 FDA inspection of the lab. The Letter found that violations of the scientific integrity regulations were so severe, and conditions so bad, that Coulston's study data was "compromised" to the point of making it "not reliable for review of drug safety."

According to its web site, the FDA has issued only 12 Warning Letters related to GLP since November 1996. Coulston is the only lab to have received more than one.

"Coulston has once again made history for unprecedented violations of federal law," said IDA Research Director Eric Kleiman. "It is the only lab ever to face four sets of formal USDA charges, and now is apparently the only lab to have two GLP Warning Letters filed against it by the FDA. How the federal government allows Coulston to continue to operate is beyond explanation." Kleiman noted that Coulston's violations have direct relevance not only to animal welfare, but also to human health and safety. "Who in their right mind would want to take a drug or device tested at Coulston?" he asked.

"We believe the FDA's devastating findings should make it clear that Coulston exemplifies the term 'junk science,'" said APNM Development Director Harriette Roller. "We intend to inform every drug company, biotech company and medical device company in the world of the FDA's unprecedented action - and to expose any company still doing business at this abysmal lab."

The FDA's latest blow comes as Coulston's regulatory problems continue to mount. In June 2001, the National Institutes of Health stopped all federal funding at the lab. This move crippled Coulston, since those federal funds had constituted approximately two-thirds of the lab's income, according to IRS records for the fiscal year ending June 30, 2000.

Coulston's only remaining source of revenue comes from a small and dwindling number of private sponsors.

"The latest FDA action should serve as a serious warning to any private drug companies stupid enough, or negligent enough, to still be doing business with Coulston," said Roller.

Coulston is also facing an unprecedented fourth set of formal USDA charges, filed in July 2001, for violations relating to the negligent deaths of two chimpanzees, inadequate veterinary staffing and care, inadequate research oversight, and violating a legally binding consent decree with the USDA. Less than a month ago, the USDA documented more veterinary care and research oversight violations at the lab.

"Coulston has repeatedly claimed that it had fixed its violations of the federal scientific integrity regulations," said Roller. "We believe that whopper should be added to Coulston's documented record of misleading federal agencies." (Evidence, in three sets of documents in Adobe Acrobat format, is available at NIHtestimony/index.html.)

"It is now only a matter of when, not if, this abysmal lab collapses," concluded Kleiman. "No amount of Coulston deception or P.R. spin can alter the fact that The Coulston Foundation has the worst record for complying with federal animal welfare and data integrity and human safety laws in U.S. history."

IDA is an international animal advocacy and rescue organization based in Mill Valley, CA. APNM is a statewide animal protection organization based in Albuquerque, NM.

Read more about IDA's campaign against the Coulston Foundation