The Centers for Disease Control and Prevention have reported 231 meningitis cases. They also say that 15 people have died because they took contaminated steroids. The drugs were made up into a compound by just one Massachusetts-based pharmaceutical firm. The CDC do not expect these cases to be the last. Their investigations have led them to the conclusion that steroids mixed up by the New England compounding center and prescribed for the easing of back pain were contaminated. The contaminants were slow-growing fungi that triggers meningitis.
The company under investigation has of course had its license taken away. But this action was too late to prevent the contaminated drugs being despatched to the following states. Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia. All states have reported cases linked to the rogue batch of steroids. Public health officials must intervene to take immediate action before these incidents become simply the precursors to an epidemic of awful sickness and death initiated by the drugs that are, for the most part unregulated, unproven and given to entirely unknowing patients.
Surely the point has finally been reached when regulation of this kind of pharmaceutical compounding is inevitable. The sector has mushroomed in last few years. They are making and selling substandard chemical treatments and in this case actually toxic medicines. All of their products are unapproved substances that are the modern age versions of carpetbagger â€˜snake oilâ€™.
Drugs remixed with well-established methods fulfil an important need. They serve to treat that minority of patients who are resistant or even allergic to the everyday drugs approved by the Food and Drug Administration. In too many cases, medicinal remixing has been beyond the FDA’s scope with supervision generally lying with State Boards of Pharmacy.
It is believed that there are up to 4000 such compounding operations now working across the country. Many of them are making and dispatching over a hundred unregulated prescriptions daily. When these compounds are delivered direct to medical facilities, doctors and clinicians are deprived of the choice of FDA approved drugs taken away from them.
The meningitis patients were unaware of the danger in the medication they were given. Their doctors were also unaware of the fact they were giving their patients less than totally controlled substances. The actual steroid that killed these unfortunate people was carried in two distinct fungi which are particularly toxic when administered to the spine. The substandard products are outputs of substandard processes where staff are poorly trained and supervised, the equipment and laboratories are less than required and or the raw materials are not sterile or poorly mixed to begin with.
[box type=”important”]These compounding labs are not even accountable to the FDA. There is no requirement on them to report quality failures and so the dangers involved are the worst kind, hidden. Unfortunately there is a long history here with another meningitis outbreak that killed 3 and a further 4000 cancer patients endangered by weakened chemotherapy mixtures.[/box]