Drug maker bends space-time continuum!
This may sound astonishing, true believers, but read on!
The FDA in a recent warning letter to J&J revealed that the company had done a poor job monitoring a drug study and cited as evidence the fact that the research staff members conducting the study were found to be giving the exact same drugs at the exact same time to two different people in two different places. In some cases, they delivered the drugs to patients as much as 65 minutes after the drugs already had been administered. In other cases, they used the same one-dose vial of drugs on multiple patients or on the same patient on different days.
Befuddled, the FDA asked for an explanation. And then another explanation. And then another explanation. J&J's explanations have been kept secret, but Antidote imagines they sounded something like this: "Don't you understand, government overlords, we at Johnson & Johnson have achieved such mastery over the elements of earth, sea and sky that we can alter time and space at will."
The warning letter is a frustrating 18-page read because the FDA has attempted to block out anything that would identify the drug being studied or the other companies involved in the study. It does offer, however, some clues:
1. Whose drug is this? Another company had submitted to the FDA an Investigational New Drug (IND) application. They teamed up with Johnson & Johnson on Feb. 2, 2005. to take over the clinical trial process, develop and market the drug. With that date, I would comb through the SEC filings for J&J, its subsidiaries and its partners for the first, second and third quarters of 2005 to see references to clinical trials and new partnerships. J&J should be commended for providing an easy-to-find and easy-to-use searchable database of its filings on its Web site. Here's one example of a partnership the company made at about that time. J&J also filed an amended statement of beneficial ownership on Feb. 3, 2005 involving Nitromed Inc., maker of BiDil, a drug for heart-failure treatment targeted at black patients.
2. What type of drug is it? The warning letter refers to "reconstituted study drug infusion solutions" that need to be used within six hours if stored at room temperature and within 16 hours if refrigerated. It says that the drug is supposed to be shipped in a refrigerated container. That rules out pills like BiDil. Infusions could run the gamut. Knowing that they are refrigerated infusions narrows it down a bit. There also are descriptions of abscesses, post-surgical infections and wound debridement. One part of the letter indicates that the focus is on infections within 30 days of surgery or trauma and "other types of complicated skin and skin structure infections." J&J, of course, is the maker of wound care blockbuster Neosporin.
3. What is the drug delivery system? The letter talks about "IV stability" and "self-administration." A drug administered via IV that is easy enough for a patient to use in the home must mean the patients have a semi-permanent stent in their arm that allows them to just plug and unplug the IV. The drug is administered in 60-minute or 120-minute drips. Talk with researchers who have looked at drugs with similar properties and say, "Any ideas?" Of course, with J&J's reach, you are going to run into people who are reluctant to say anything that might make the company mad.
4. Dónde están los pacientes? The letter says that J&J sent the agency "Notas De Enfermeria" (infirmary notes) and a "Planilla de estabilidad" (stability list). This indicates that at least part of the study was conducted in a Spanish-speaking country or a predominately Spanish-speaking part of the U.S. The FDA says that in some cases a Spanish-language informed consent document was not used even though "demographics of the region indicated a large population with native and preferred language of Spanish." Nothing like getting people to sign a form they don't understand.
5. Why do these screw-ups matter? The FDA notes several potential problems with these mistakes. In one case, nine patients were supposed to receive treatment for their wounds and infections on the same day, but treatment was delayed for as long as 11 days. The delay "would have placed them at increased risk for worsening of primary infection, dissemination of infection, sepsis and death."
There are definitely more questions raised than answers given, as is often the case with these warning letters.
If anyone finds out how exactly J&J managed to defy the rules of space and time that restrict the rest of us, please let me know. You need to be a registered member of ReportingonHealth.org to leave a comment, so if you haven't joined yet, click here. It's easy, quick and free.