The Porton Group, the private equity partner of the British Ministry of Defence, has accused 3M Corporation of "negligence and possible recklessness putting lives at risk" due to "botched" 2007 clinical trials of a medical device called "BacLite," which can detect within five hours the presence of the potentially deadly MRSA/staph "superbug." The trials were conducted after notification of the U.S. Food and Drug Administration (FDA) and after seeking FDA advice, which 3M proceeded to ignore, according to Porton. 

As a result, Baclite was withdrawn and the group that sold it to 3M are blaming 3M.

 MRSAs have killed more people annually than AIDS yet has no Hollywood celebrities talking about it. The British group claim alternatives to BacLite's inexpensive, five-hour or less detection system are either far more expensive, DNA/molecular detection systems, or growth solutions, which take 1-2 days to detect the presence or absence of MRSAs.   BacLite was invented by researchers in the British Ministry of Defence using photo-fluorescent technology based on the firefly and originally was to identify biological weapons of mass destruction, such as Anthrax. 

At a press conference today in Minneapolis, Porton attorneys cited a secret report (how did they get it?  Hacked emails?  Illegally-obtained?) by an 11-member internal 3M technical committee that confirmed 3M testers had made fundamental errors that led to unacceptable 50% reliability results. The results were in contrast to the 95% results achieved in 2006 in British-run trials and after which European Union (EU) regulators allowed the sale of BacLite to British hospitals starting in 2006 - based on those test trial results. 

The 3M report cited errors by 3M testers such as refrigerating the "comparator" solution at temperatures colder than test protocols permitted, thus artificially impeding the growth of MRSAs; and the use of a different comparator solution than had been used in the successful European trials, despite FDA's allegedly express approval of using the same comparator as was used in Europe. 

In February, 2007 3M purchased the rights to BacLite from Acolyte, consisting of the British- Ministry of Defence-wholly-owned subsidiary, Ploughshare, and a group of equity investors called The Porton Group.   

The attorneys for Porton cited reasons they say the FDA should conduct an investigation, claiming there was evidence that 3M had possibly misled the FDA when it: 

- failed to disclose to FDA the contents of the secret technical report on the multiple errors leading to failure of the U.S. trials;

- failed to explain why another round of tests were not conducted consistent with its own technical committee's and FDA's advice; and

- failed to disclose possible financial conflicts of interest that might explain such 3M decisions as:

- not re-doing the clinical trials in November 2007 to correct the errors pointed out by its own internal technical committee in their secret report;

- withdrawing BacLite entirely from the European market at the end of 2008, one year from the term of the purchase and sale contract;

- at the end of 2008, removing BacLite system equipment from some U.K. hospitals, despite being told by some hospital personnel that, according to one physician, BacLite was "easy to use" and "very reliable" and "could save lives;" and

 - in May or June 2009, with more than six months to go in its purchase and sale contract, appearing to announce an effort to sell its own more expensive competitor to BacLite called "FastMan," which used molecular technology to detect MRSAs but had not met reliability standards.  3M's medical products division is also promoting apparently another similar product, "Simplexa." 

  The CEO of the company wholly owned by the British Ministry of Defence, Mr. Pete Hotten,  issued a written statement, unusual for a representative of the British government: "We are disappointed that 3M Corporation failed to get an excellent diagnostic technology [to detect MRSAs in incoming hospital patients] into the market, though what 3M's own [technical committee] officials describe as avoidable mistakes. [We] believe 3M's decision not to correct their mistakes and to reapply for FDA approval is contrary to its obligation to its partners." 

The two attorneys who signed the public petition to the FDA and the letter, Messrs. Davis and Hopper, cited several FDA regulations as the basis for their request for an FDA investigation and public hearing, including a regulation permitting an administrative hearing and a third-party citizens' petition when there is evidence of misconduct that could affect the public health (21 C.F.R. Sections 10.25, 10.30, 12, 13, 14, 15, or 16 and 54.2), and specifically, to look into any potential financial conflict of interests by 3M that could have influenced the outcome of its clinical trials (21 C.F.R. Section 54.4(1).) 

 In addition, in their letter to FDA the two Porton attorneys cited additional FDA regulatory authority: (1) to initiate an audit of data derived from the 3M investigators and its own internal (and still secret) technical report concerning 3M's fall 2007 BacLite clinical trials; and (2) to appoint an independent clinical investigator to re-conduct the 3M trial study because of the serious public health - potential life-death ramifications of 3M's clinical trial failure and errors pointed out by its own technical committee.