We could have filled this and other blogs this week with all of the news and commentary about Anthrax. But what does that have to do with the Heparin Catastrophe. It just drives home even harder, the point we have been making on this blog since February that any firm in the pharmaceutical industry had to do the utmost to insure absolute purity of its drugs. Not only has there been on the front burner of the FDA agenda the risk of counterfeit drugs, but more seriously, the risk of intentional tampering, with malicious intent. Any company that makes drugs, must make them with such utmost security, that no opportunity to infect large numbers of people could exist.
That reality is even more important with a product like Heparin, that is designed to be taken, not only intravenously, but also given to our sickest individuals, those on kidney dialysis. Nothing less than an absolute guarantee of purity is required, and exporting the manufacture of raw materials and expecting a federal agency that has a 30 year backlog, is not the way to do it.
Attorney Gordon Johnson http://heparin-law.comhttp://tbilaw.comhttp://waiting.comhttp://vestibulardisorder.comhttp://youtube.com/profile?user=braininjuryattorneyg@gordonjohnson.com800-992-9447
©Attorney Gordon S. Johnson, Jr. 2008
Date: 8/8/2008 7:53 PM
By LOLITA C. BALDOR
Associated Press Writer
WASHINGTON (AP) _ The Army has created a team of medical and other military experts to review security measures at the research laboratory where the scientist linked to the anthrax mailings worked.
Army Secretary Pete Geren has asked at least a dozen military and civilian officials to scrutinize safety procedures, quality controls and other policies and practices at the biodefense lab at Fort Detrick, Md., Army spokesman Paul Boyce said Friday.
To date, the Army has offered no explanation for how its biosecurity system, which is set up to catch mentally troubled workers, failed to flag scientist Bruce Ivins for years. Ivins, the microbiologist accused of sending anthrax-laced letters in 2001 that killed five people, committed suicide last week as the FBI began closing in on him.
Boyce said Friday that Geren met with military officials on Thursday night, then traveled to the high-security Army Medical Research Institute of Infectious Diseases, known as USAMRIID, at Fort Detrick on Friday morning to talk with leaders there.
Boyce said the team, which is only now being formed, is not targeting individuals but instead will be reviewing documents, procedures and other safety measures to ensure security at the military biodefense lab. He added that as yet there are no deadlines for reports from the team.
The facility has come under intense public scrutiny as more details have spilled out about therapists’ concerns that in recent years Ivins had become paranoid, delusional and bent on violence.
Investigators said that between 2000 and 2006, Ivins had been prescribed antidepressants, antipsychotics and anti-anxiety drugs. By 2005, the government had matched anthrax in his lab to the strain that killed five people.
It wasn’t until November 2007, after the FBI raided his home, that Fort Detrick revoked Ivins laboratory access.
Army officials have declined to discuss any other efforts to either watch Ivins more closely or put other restriction on him prior to the November action.
Instead, they have stressed that safety procedures at the lab have included ongoing personnel evaluations, which rely largely on employee self-reporting medical or criminal problems and observations by other workers and supervisors.
Boyce said the impending review will be headed by a two-star general, and will include representatives from the medical research command, the Army’s surgeon general, and Army operations.
While the lab has strict security measures meant to weed out troubled scientists, there are lingering questions about why it took so long for supervisors to restrict Ivins access to the deadly toxins.
Ivins’ attorney, Paul F. Kemp, says the government’s evidence was too weak to trigger any action.
But members of Congress have questioned whether adequate action was taken, and they have pledged to investigate the case and lab security as a whole.
Overall, there are nearly 1,400 biological defense labs, with an estimated 14,000 scientists working with the world’s deadliest pathogens.
In 2005, the Pentagon ordered new “biosurety” safeguards requiring workers such as Ivins to be “mentally alert, mentally and emotionally stable.” The program was meant to ferret out workers with mental problems and those who attempted or threatened suicide.
Colleagues have differed in their observations of Ivins, with some saying they never say signs of mental illness, and others describing him as a “manic basket case” or saying they’d seen him openly weeping at his desk.
Ivins himself wrote in a July 2000 e-mail that he might be suffering from a paranoid disorder.
“I get incredible paranoid, delusional thoughts at times, and there’s nothing I can do until they go away, either by themselves or with drugs,” he wrote that August, in an e-mail included in government documents released Wednesday.
Copyright 2008 The Associated Press.
Attorney Gordon JohnsonChair Traumatic Brain Injury Litigation Group, American Association of Justice
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