Lap Banders: Write a Letter to Washington!!

You may have seen a story about problems with pelvic mesh triggering a report by the independent Institute of Medicine (IOM - a part of the National Academy of Sciences) condemning the FDA for not requiring post-marketing surveillance for medical devices a couple of days ago:

Risky pelvic mesh highlights worries about FDA

Well, this report has generated a HUGE pre-emptive response from the medical device industry, big enough that it got its own (likely unwanted) press attention today.  How much do you want to bet that a big contributor to this attack on the IOM is Allergan??

Study of medical device rules is attacked, unseen

Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry.

If you want to do something to support the IOM in their fight to require the FDA to force doctors to report problems with medical devices, including the LapBand, please write a letter to the person at IOM spearheading this project:

Abigail E. Mitchell
Senior Program Officer
Keck Center
858
500 Fifth St. NW Washington, DC 20001
[email protected]

I wrote her a long letter explaining how the LapBand manufacturers are able to hide problems with their product, and have a co-conspiracy with the LapBand surgeons, who have inappropriate financial relationships with the LapBand manufacturers and are motivated against raising a stink about problems with the product that generates their cash-cow business, which brings patients back over and over and over for fills and unfills, plus explantations, replacements, etc.

I even have letters sent to me by a NON-LapBand surgeon who has had to remove numerous bands from people, demonstrating the lack of interest or responsiveness from the manufacturers AND the FDA in tracking problems with the band - he was hoping I could get the documents to someone who could DO something about this.  I hope they are seen as smoking guns in this battle.

DO YOUR PART!  PAY IT FORWARD!!  TELL WASHINGTON THAT THIS LACK OF POST-MARKETING SURVEILLANCE IS HURTING PEOPLE!!!

Not only is it hurting people but it is leading people to make uninformed decisions because they believe everything they see on TV. The one I kind of growl about is the commercial for the Realize Band that touts it as the least invasive, most successful of ANY weight loss surgery.
All I can do is let my jaw drop and yell, "BULL****!!!"

From
http://www.fdamatters.com/?p=1179 

In the House of Representatives, there are three committees that exercise "oversight and investigations" jurisdiction (O&I) over the FDA. The primary ones are the Energy and Commerce Committee and the Oversight and Government Reform Committee. The Appropriations Committee also conducts O&I.

The Energy and Commerce Committee intends to investigate the scope of work and expenditures under FDA’s contract with McKinsey & Company, an international management consulting firm that has been asked to improve the productivity of the generic drug review office. Once the Energy and Commerce has reorganized itself for the new Congress and priorities are set, there are sure to be more areas under investigation.

The Oversight and Government Reform Committee is off to a faster start because outgoing chair Representative Edolphus Towns (D-NY) and incoming chair Representative Darrell Issa (R-CA) were already working together on manufacturing problems in the drug industry. This has now become an investigation of whether understaffing in FDA’s Puerto Rico office led to inadequate oversight of industry.

Some top level influence will be needed, for the longhaul, for a wide range of issues. The FDA remains very effective at reducing overall health levels within the United States by focusing (as regulated from above) on risks rather than benefits. While the rest of the world progressed with band procedures in the 1990's, the USA remained characteristically 3rd world in status on such matters. During that period hundreds of people died who, all things considered, would have lived had that surgical option been available. None of those dead wrote angry letters to their elected representatives. Nor do any of the tens of thousands of other dead who would have lived, or lived longer, had the US been as advanced as, say, Mexico or Greece or any number of other countries in terms of treatments available (without the risk of physicians being separated from their families and placed in jail for practicing unapproved medicine).

Meanwhile, it only takes one death, or threat thereof.... just ONE... in order for congressional hearings to be scheduled on the risks of some drug or device.

That is the balance.

It mirrors the classic (and fortunately increasingly rare) stance of the PCP. Patient dieing from diabetes and related disorders that drugs alone cant cure.... that's merely part of life.  On the other hand, so much as as 0.3% chance of death from a surgical intervention? Those odds are unacceptable.

The patient may die from passive or active non treatment, but above all, do no harm. Death from inaction or coercive witholding of proper treatment.. that's fine.... but just do no harm.

Former FDA Intern,
Eric Klein

Eric,
To bring real "balance" to your comment, as the founder of Obesity Help do you care to reveal how much in advertising your site receives from Allergan and Lap Band surgeons?

Sure.
Allergan... approximately zero. (Yeah, tell me about it). Not what one might think. ... wait, ok... see the "Choice" banner showing up lower right corner?  That's Allergan. Might be 0.5 % of our income or something like that.

As for lap band surgeons... no bias that I'm aware of in surgery type & surgons sponsoring us. Maybe 1/4 overall do only band, 1/4 do no band, 1/2 do band & other? Something like that. Probably the same re advertising.

WAIT  WAIT  WAIT.....


Why are you helping Allergan out by allowing them to use that bull**** link ?

When Allegan removes their inferior product from the market and" Implements new policies to provide optimal care for those affected by obesity undergoing weight-loss surgery and invest in new research that will reduce the prevalence and burden of obesity"
I will sign their damn petition, but I cannot contribute to their greed while their product continues to harm their cash cows.

bump

.....

The FDA has a job to do.  It regulates, among other things, drugs and medical devices.

The requirements for post-marketing surveillance (AKA Phase IV studies) of drugs were established for a variety of reasons, not the least of which is that once a drug gets approved, and is put into a wider variety of people than the limited numbers and types of people who were involved in the clinical trials, new and unforeseen problems can occur.  When this happens, limitations, warnings or withdrawal of approval for a drug can and should happen.  Sometimes, that means that SOME people who could benefit from the drug get screwed - for example, I had a pretty good response for my IBS symptoms with Lotronex, and I was not happy when the FDA ordered it off the market - BECAUSE IT KILLED SOME PEOPLE!  This problem didn't become evident until after it was taken by more people than the relatively limited number that were involved in the trials.  http://www.webmd.com/ibs/news/20001128/ibs-drug-withdrawn-af ter-less-than-year-on-market

In the case of the LapBand, as well as other medical devices, this post-marketing surveillance is CRUCIAL, just as it is with drugs.  The surgeons are financially motivated to turn a blind eye to the problems, and have no incentive to report them either to the FDA or the manufacturer; the manufacturers are financially motivated to turn a blind eye to the problems as well.  Without reporting requirements like those that are required for drugs, how are these systemic problems going to be brought to the attention of the regulatory agency??

I'm not saying the Lapband should be taken off the market (even if I BELIEVE it should be).  I'm saying there needs to be a reporting requirement that can collect the data necessary to see if there IS a systemic problem with it, that should limit its use or require it to be taken off the market.  There are other surgeries that can be provided; there are improvements to the band that could be required; there are WARNINGS that should be given to patients who decide they want one if the problems don't rise to the level of ordering taking them off the market.  All of these analyses require adequate and mandatory post-marketing surveillance, and it is a unethical that it is not already required - in my opinion, of course.

I like your specifics.
Web URL even. If only more OH members would reference external sites as part of discussions. ... ok, I'm suddenly feeling inspired now... what if several hundred OH members regularly did exactly that on OH....

My comments above were explicitly (and transparently) uber-focus in nature. I.e., technically inoring the actual specifics at hand... which I intend to study. (Thanks for bringing them up here).

I'm perhaps just a _tad_ too proud in my jadedness. Or, pehaps not.  The actual specifics are always relevant, case, by case.  Before silicon breast implants were banned for 15 years, for example, I'm sure there were a lot of specific problems in need of addressing.

My thoughts tend toward the regulatory big picture whereby, regardless of the particulars, one voice of harm can outdo hudreds of non-voices of benefit. Overall, the ratio is simply adverse. Reminds me of conversations I've had with my wife (perhaps others could relate) comparing ACTUAL risk of death by freeway versus risk of death by plane crash. The later gets the attention.

Another example I think of: phen-fen.  Primary pulomary hypertension is a risk within unmedicated morbidly obese. That pre-existing risk accounted for much of the post-pondamin diagnosis. When all the class action suits were said and done, I don't know if there were more than perhaps 100 (I could be way off) confirmed diagnoses of PPH in individuals who had used pondamin. [Note -- I'm sure I'm misspelling a lot here].  So, maybe use of one of the phen-fen drugs resulted in 50 individuals getting PPH who wouldn't have otherwise done so, where the other 50 would have wound up with it anyway on their own.  That could be a count of 50 against phen-fen.

Meanwhile, on the other hand, the withdrawal of phen-fen was THE immediate cause of the initial spike of the obesity epidemic (if you compare graphs of such with years; but that's an aside anyway...  the longer term demographics were geared as they were in any case). The number of people who DIDN'T die from 1992-1997 as a result of phen-fen... how large are they in number. The reasoning goes....  maybe 10,000. But none of those non-deaths resulted in congress or the media stirred up with fear.  10,000 to 100 ratio. 100 to 1.

Ok, I think I'm on the verge of rambling. I hijacked your specific in order to generalize to a "main bigger picture" point that I nevedr hear anyone raising, and I think both are valid, in parallel.