SMOKINCHOICES (and other musings)

October 26, 2012

Fungus seen in steroids @ pharmacy

Fungus visible in steroids at Mass. pharmacy

By Bob Salsberg ASSOCIATED PRESS

BOSTON — State officials said Tuesday they found unclean conditions, including visible black specks of fungus in steroids and a leaking boiler near what was supposed to be a clean room, at a pharmacy linked to a deadly outbreak of meningitis.  Gov Deval Patrick said Massachusetts has moved to revoke the licenses of the New England Compounding Center and three pharmacists there. He also has ordered the state pharmacy board that oversees similar companies to conduct surprise inspections and take other steps to tighten oversight.

The first such inspection was made at a compounding pharmacy yesterday, state health department spokesman Alec Loftus said. He would not reveal the name of the facility and said results of the inspection were being reviewed.

State officials said a preliminary investigation found that the NECC shipped orders from the lots of steroid shots suspected in the meningitis outbreak before its own tests came back confirming that the lots were sterile. In some cases, they said, drugs went out up to 11 days before test results came back.

  • Officials also said the company, in Framingham, just west of Boston, operated as a drug manufacturer by producing drugs for broader use, rather than filling specific prescriptions for specific doctors, which is all its license allowed.

“Over the years and for a variety of reasons, some pharmacists have transformed from your neighborhood drugstore into large-scale manufacturers that sell products across state lines,” Patrick said.

The outbreak of meningitis, an inflammation of the lining of the brain and spinal cord, has sickened more than 300 people, including 23 who died, in 17 states. Eleven Ohioans have been sickened.

Each victim had received a steroid shot, mostly for back pain. Federal health officials matched the shots produced by the company to the outbreak after finding a deadly fungus in more than 50 unopened vials there, but they have not said how the doses were contaminated.

  • New state documents released this week detailed problems an outside firm hired to make an assessment found there years ago.

The state documents, obtained by the Associated Press under a public-records request, say investigators in 2006 found inadequate contamination control and no written standard-operating procedures for using equipment, among other problems. The problems were corrected that year, and a state inspection in May 2011 as the company prepared to update its facilities found no such issues.

  • In a letter sent Monday to an attorney for NECC, the U.S. House Committee on Energy and Commerce sought nearly 10 years of documents about safety and quality issues at the company. It indicated that as far back as 2002, officials from the Food and Drug Administration and the state conducted joint probes of the company after receiving a report about a steroid shot. Those probes preceded a 2004 joint investigation of the center by the FDA and the Massachusetts Board of Registration in Pharmacy.

(Jan’s comment: 

It appears that the problems have been ongoing for years, and yet while known,  change and corrections had not been required or done.  Public safety and risk factors were not being protected.   People are NOT SAFE.   Too many are harmed or killed. Governor Patrick is to be admired for trying to get a handle on this and taking appropriate action. 

The public has a much larger problem, for we are all being subjected  to danger from 1000’s of business purported to be operating within safety guidelines which are supposed to protect life and limb.  But it is only a mirage.  Our tax dollars are being used to imperil us as the  number of injuries and deaths by medicine, whether accident,  improper prescriptions being given,  accidents made on hospital instructions,   faulty or incompetent delivery by professionals to unsuspecting patients as well as procedures which don’t do what they are purported to be doing.  These ‘accidental deaths’ total in the hundreds of thousands annually.  All this continues to happen even as the financial burden has become prohibitive.   The tax dollars are mentioned here not to attack our president or anything he has tried to accomplish for us all medically, but the system itself which has painted itself with colors of nobility and compassion (my Gawd, who of us doesn’t respect science?)  The reality is,  medicine in the U.S.A. is NOT worth the price one pays.   Medicine in our country treats disease;  that’s what they study in school and that’s what they attempt to do in practice.   

The entire construct is all but useless if one seeks answers and care on how to get and keep ‘robust health’.  For that, essentially, one needs  not allopathic medicine , but some form or branch of ‘alternative’ care. .  .     Medicine in our country is totally organized toward BUSINESS and the pursuit of profit.  It is good to think about these things and dream up solutions for potential change.  For the present, we must deal with ‘what is’   and we have governmental departments which govern every part of life.   There are regulations for most businesses.  With such a large population, these agencies should be funded even more lavishly that in days past when it was business as usual.   The cuts to government services  are seriously hurting our way of life and there is urgent need to bring all these agencies and departments up to functioning, practical standards.  Actually, we shouldn’t be running one without the other.         We need rules and regulations and the force of law behind them.  People are entitled to this.  You know it and I know it and everybody does.   Jan)

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