[caption id="attachment_4070" align="alignleft" width="350"] Rectal smoke was used in the 18th century to resuscitate nearly drowned victims[/caption]
If someone is blowing smoke up your butt today, it probably means they are feeding your ego with insincere compliments. But a few hundred years ago people literally blew smoke up other peoples’ keisters for a variety of medicinal purposes.
This was the enlightening takeaway from a recent visit with my GI surgeon, Julius Bonello of Peoria, Illinois. Bonello wrote an article published in the December/January issue of History Magazine detailing the medical history of tobacco and an apparatus used to literally blow smoke up a patient’s derrière.
According to Bonello, rectal fumigation (also known as smoke enemas, tobacco enemas, or smoke clysters) were used during the 17th and 18th centuries to treat bowel obstruction, constipation, strangulated hernias, colic, and even to resuscitate stillborn babies.
The practice of rectal tobacco infusions during surgery for muscle relaxation was even documented in the January 1897 issue of the Boston Medical and Surgical Journal (now known as TheNew England Journal of Medicine). As if smoke enemas alone were not strange enough, there was an even more bizarre method put in place to prevent overdose. A cigar tied to a string was inserted into the rectum and then withdrawn once the desired effect was achieved.
Resuscitation of drowning victims was, perhaps, the most interesting use of the smoke enema, according to Bonello.
France was the first to adopt the technique, followed closely by London.
Bonello noted that nicotine has found its way back into medicine in recent decades as scientists have attempted to produce nicotine-based vaccines against HPV, HIV, rabies, Ebola, Alzheimer's, depression, obesity, and even chronic ulcerative colitis.
[caption id="attachment_4054" align="alignleft" width="338"]Danger, device maker! Counting to 15 is a lot tougher than you think[/caption]
Device makers are by now quite aware that FDA-inspected firms have 15 working days to respond to an inspectional form 483, but is this always consistently applied? It would appear not. Whether that difference makes a difference in the issuance of warning letters is tough to know, but one might think there are reasons for misgivings.
An example of when FDA is lenient (and I assure the reader this is not the only such case) is the Dec. 9, 2014, warning letter to Customed of Puerto Rico, for an inspection that ran July 14-31. Customed responded first within the 15 working day time frame with an Aug. 21 response, but FDA also considered a Sept. 8 "response update" in its consideration of the company's efforts to come into compliance.
Conversely, FDA did not allow a response beyond 15 days in the November 2014 warning letter to Stanmore Implants of Elstree, UK. The inspection took place July 28-31 last year, and FDA indicated that the company had inked three responses. The first of these was dated Aug. 21, which would have just made the 15-day turn-around mandate.
Stanmore replied twice more, on Sept. 26 and Oct. 15, which the agency declined to consider in its response to the company. It's obviously impossible to know whether consideration of those responses would have changed the outcome without filing a FOIA request for those documents, but they certainly could not have hurt the company's chances of avoiding a warning letter, not to mention the detention FDA slapped on the company's products.
One obvious question is: When is a second response a "response update" and when is it not?
But let's also ask about the justification for the differential treatment. Is it at the discretion of the issuing office? The Stanmore letter came from the Office of Compliance, which may feel it has to be a stickler for this sort of thing, whereas the Customed warning letter came, not unexpectedly, from the San Juan district office.
Whatever the explanation, a bit of disclosure might be appropriate here. I'm not necessarily arguing for a formal policy, but these warning letters – which are intended as public statements as David Kessler made clear back when he implemented the warning letter program more than 20 years ago – might be a good place for an explanation as to why the 15-day deadline is or is not observed.
Detention issue resurfaces?
We all remember the controversy that erupted in 2001 when regulatory attorney Larry Pilot challenged then-CDRH director David Feigel on the issue of whether detention was unfairly applied to non-U.S. companies. Pilot intimated that U.S. device makers were less likely to have to deal with a quarantine of their offerings, and the Stanmore warning letter would seem to bring that issue back up.
The reason I ask is that I could not find any indication that the devices in question had been recalled, although FDA said there had been a couple of instances of implant device malfunctions. I'm not sure that a handful of device malfunctions is all that conspicuous, though, given the absence of a denominator.
Beyond that, the Stanmore letter dealt largely with documentation issues, which often make up the entirety of a warning letter bill of fare, so there's no answer to be found there. Maybe we should ask Pilot and Feigel.
The Las Vegas casinos were teeming with activity last week, but the true bets from orthopedic surgeons who descended upon the city during the American Academy of Orthopedic Surgeons (AAOS) weren’t originating from the tables in their hotel lobbies. Smart money was being placed on what would happen regarding the Sustainable Growth Rate (SGR). Ultimately the House would overwhelmingly pass the bill. But the Senate went into recess before making a final vote.
For the uninitiated, in 1997, Congress adopted the SGR formula as part of the Balanced Budget Act. The idea was to control federal health care spending. The SGR formula – in broadest terms – keeps the total increase in Medicare reimbursement to physicians from exceeding the change in the Gross Domestic Product (GDP). But every year since its passage, the cost of healthcare delivery has gone up faster than the increase in GDP.
The chatter from AAOS annual meeting was centered around the implications of SGR - so much so that AAOS had a round-table discussion for reporters hosted by Thomas Barber, Chair of the AAOS Council on Advocacy.
Barber noted that on the ground level, most physicians are not aware of the scope of the issue and what it could mean.
“Most people [surgeons] today don’t understand that 6% of their pay is at risk,” he said.
The message at the conference was that surgeons and device makers had best get prepared for their worlds to change and to take ownership to help develop and mold a model where they define quality rather than allowing government agencies or elected officials to do it for them.