MINNEAPOLIS, May 11, 2011 /PRNewswire/ -- The famous U.S. 3M Corporation today was alleged by the private equity partner of the British Ministry of Defence, the Porton Group, to have exhibited "negligence and possible recklessness putting lives at risk" due to 3M's "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 and public legal papers.
MRSAs have killed more people annually than AIDS. The only alternatives to BacLite's inexpensive, five-hour or less detection system available today 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 seeking to identify biological weapons of mass destruction, such as Anthrax.
At a press conference today in Minneapolis, next door to "twin city" St. Paul, Minnesota, home of 3M's international headquarters, attorneys for Porton, Lanny J. Davis of Washington, D.C. and Robert Hopper of Minneapolis, cited a secret report by an 11-member internal 3M technical committee that confirmed 3M testers had made fundamental errors that led to unacceptable 50% reliability results. These results were in contrast to the 95%+ results achieved in 2006 in British-run trials when the Porton and the U.K. Ministry of Defence still owned BacLite, i.e., meaning European Union (EU) regulators allowed the sale of BacLite to British hospitals to begin in 2006 based on verifiable test trial results.
The secret 3M report cited many 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.
Background of 3M Purchase of BacLite
In approximately late 2006, 3M's chairman and CEO, George Buckley, through an intermediary, sought to purchase rights to the British Ministry of Defence-invented "BacLite," a rapid, inexpensive, MRSA-detection device approved for sale in Europe in 2006. A purchase and sale contract was signed in February 2007 between 3M and the combined company, Acolyte, comprising the British- Ministry of Defence-wholly-owned subsidiary, Ploughshare, and a group of equity investors called The Porton Group. 3M had approached Acolyte and argued that it was in the best position to maximize global sales of BacLite given its own health products division expertise and its global experience. 3M did due diligence on the efficacy of BacLite, including data from the U.K. clinical trials, and after its purchase, touted those data from the U.K. trials and the reliability of BacLite on its own website and its marketing procures. (See Exhibit A, H).
In the purchase and sale contract signed in February 2007, 3M promised to "actively" market BacLite and to obtain regulatory approvals "diligently" in the U.S., Canada, and Australia.
At an international telephonic press conference held today in Minneapolis, Minnesota, a short distance from 3M's corporate headquarters in St. Paul, Minnesota, Porton's U.S. attorneys, Lanny J. Davis of Washington, D.C. and Robert Hopper of Minneapolis, Minnesota, announced they were filing today a "citizens' petition" and letter with the FDA seeking an investigation of 3M and a public hearing under applicable FDA regulations.
Grounds for FDA Investigation and Hearing
The attorneys cited at least three grounds for FDA under applicable regulations to conduct such an investigation and public hearing in 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 (and still hasn't). (Just recently, on its Internet cite, 3M's medical products division is promoting apparently another similar product, "Simplexa.")
Statements by Equity Investors and British Government Co-Owners of BacLite
Harvey Boulter, the CEO of the Porton Group, issued a public statement saying
"We trusted 3M when they urged us to sell after promising in writing they would 'actively market' this product globally and, specifically, would 'diligently' seek to obtain regulatory approvals in the U.S., Canada, and Australia" through the end of 2009," Mr. Boulter continued. "But we believe they broke that promise, and we believe it is possible that, as a result, hospital patients in Europe, the U.S., and all over the world could have been unnecessarily exposed to MRSAs."
"We will not rest," he stated, "until 3M is held accountable for walking away from its obligations."
The CEO of the company wholly owned by the British Ministry of Defence, Mr. Pete Hotten, also issued a written statement, unusual for a representative of the British government.
Mr. Hotten stated: "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."
Legal Authorities for Porton Petition and Request for FDA Investigation/Hearing
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.
Authority for European / British Independent Public Health Investigations
The Porton attorneys also cited International Cooperation Agreements between the EU and its European Medicines Agency, the U.K.'s Healthcare Products Regulatory Agency (MHRA), and the FDA to allow the EU to request documents and to conduct its own investigation of 3M's BacLite clinical trial failures and the reasons they occurred, in contrast to the successful trials qualifying BacLite for sale within the EU.
"To this end, we intend to petition the EU European Medicines Agency and the U.K. MHRA to invoke their authority pursuant to International Agreements [and their own Good Clinical Practices Directives] to...undertake an investigation of 3M Corporation regarding its failed clinical trials," Davis and Hopper wrote in their letter to FDA.
In fact, the two Porton attorneys cited the U.K.'s Healthcare Regulatory Agency's requirements to conduct such an investigation when it is presented with "evidence that shows significant and unjustified departures...for the conduct of clinical trials, especially when such evidence shows the clinical data to be unreliable and/or there exists a number of non-compliances across areas of responsibility, indicating a systemic quality assurance failure" - "as is the case," Davis and Hopper wrote, "with 3M Corporation and the BacLite clinical trials."
FOR FURTHER INFORMATION: GO TO http://www.MRSA-INJUSTICE.com
(SEE FDA LETTER, ATTACHED FACTUAL CHRONOLOGY, RELEVANT DOCUMENTS, AND OTHER RELEVANT INFORMATION ON WEBSITE.)
FOR FURTHER INQUIRIES CALL: U.S. MEDIA: Robert R. Hopper & Associates: +1-(763)-476-5809 email@example.com Maddie Melendez: +1-(202)-756-8293 firstname.lastname@example.org EUROPEAN MEDIA: Catherine Nicholls: +44-7789-644-979 email@example.com
SOURCE The Porton Group