Even the Autoclave Was Dirty
Health officials from the FDA investigating conditions that led to the contamination of methylprednisolone acetate made by the New England Compounding Center found that staff documented cases of mold and bacterial growth in supposedly sterile rooms about four dozen times since January. The outbreak has made 338 people sick and killed 25. In addition to a leaky boiler and dirty floor mats, the air conditioning that regulates temperature and filters the air to prevent bacterial growth was turned off every night. Even the autoclave, used to sterilize equipment, had a "greenish yellowish discoloration." No preservatives are added, so it has to be made under sterile conditions. Compounding pharmacies are generally regulated by the state, but the FDA will step in to assist with serious problems.
Doctors Paid, Studies Edited
After reviewing over 5000 pages of documents, a U.S. Senate Committee has found that Medtronic paid around 210 million dollars to doctors to conduct and author studies on Infuse and heavily edited the journal articles but did not disclose this in the articles. Infuse is a genetically engineered protein designed to be used in spinal surgeries in place of a bone graft from the pelvis. Medtronic said Infuse was the better technique which was not true and none of the 13 studies sponsored by the company reported any side effects. Medtronic denies allegations of influencing studies and did not agree with the way the payments to physicians were described. The U.S. Food and Drug Administration approved Infuse for use in 2002, and in 2011 it brought in approximately 800 million dollars in sales.