Aetna: Draft letter #2 : DS is not investigational (very long)

[Guest guest]

Hi Everyone,

Here is my 2nd draft for anybody who is interested. Many more

reference added:

Hull

Dear Aetna,

I would like to address your claim that the biliopancreatic diversion

with duodenal switch (BPD/DS) procedure being " investigational " .

Before doing that, I would like to briefly discuss the disadvantages

of the alternatives.

Vertical-Banded Gastrectomy: Not an effective procedure

Balsiger, in his 10 year follow up study at the Mayo Clinic reports

that " only 26% of the VBG patients have maintained a weight loss of

at least 50% of excess body weight " . In addition he reports

that " Vomiting one or more times per week continues to occur in 21%

and heartburn in 14% " . Balsiger concludes with " Thus the VBG is not

an effective, durable bariatric operation " . [1] MacLean (CPB

reference 11) also reports poor long-term results of the VBG

procedure.

Roux-N-Y Gastric Bypass: The " Gold Standard " is getting tarnished

The other procedure approved (RNY) has a number of significant

disadvantages. The pyloric valve is bypassed and the rate of food

movement into the small intestine is not regaled. This results in

the well-known phenomena called " dumping syndrome " which can cause an

individual to feel sick or even faint. Supporters of the procedure

actually refer to this unpleasant side effect as a benefit because it

helps the patient form an aversion to sugar [2]; however, Mallory

reported that his " study fails to demonstrate a significant

relationship between dumping severity and weight loss " [3]. The

extremely small " pouch " (1 oz) that replaces the stomach causes

vomiting whenever the patient eats even the slightest amount beyond

what the pouch can handle. [4] In addition, the patient cannot eat

and drink at the same time. Meat intolerance is reported in the

majority of the patients [5]. The volume of food that the patient is

allowed to consume is so small that it causes severe social problems

in restaurants and other social eating occasions. Patients will

vomit or get food stuck in their pouch if it is not mashed into the

tiniest peaces before swallowing. Sanyal reports a rate of stenosis

and ulceration of 12.5% and 12% respectively. [6]

The RNY procedure has mixed results in terms of efficacy. Initial

weight loss is reported to be 60-70% peaking at 18-24 months.

[1,7,8,9,10,11,12,13,14]. However, long term studies consistently

show weight regain after 3 yrs leading to excess weight loss of only

50.9% and 57.5% at 4-5 yrs [11,12]. Avinoh reported in a 6-9 year

followup that 24% of the patients were once again morbidly obese, and

only 74% of the patients had loss more than 50% of their excess

weight. [15]. Brolin reported that 37 out of 91 patients regained

greater than 15% of their excess weight.[7].

I have experienced these problems first hand. Both my wife and

father-in-law had the RNY procedure in 1997 and 1996 respectively.

Although I have been morbidly obese for many years and my physician

originally recommended bariatric surgery for me in January of 2000, I

was hesitant to undergo this surgery given the consequences I have

personally observed.

When I learned about the BPD/DS procedure, my point of view changed.

This procedure does have side effects (foul stools, vitamin

supplementation required), but I consider these to be much more

reasonable side effects to live with than the RNY.

Biliopancreatic Diversion with Duodenal Switch: The Platinum Standard

Now, on to the issue of the BPD/DS being claimed to

be " investigational " . According to our insurance contract:

" … a procedure will be determined to be experimental or

investigational if there are insufficient outcomes data available

from controlled clinical trials published in the peer reviewed

literature to substantiate its safety and effectiveness for the

disease or injury involved. "

I will set out to first prove the efficacy of this procedure by

sighting peer-reviewed literature including some of your own

references! Then I will site more recent references that show the

safety of this procedure. Finally I will demonstrate that there is

sufficient data currently available to substantiate these conclusions.

Effectiveness of the BPD/DS procedure:

You own policy bulletin #157 admits that the BPD/DS is

effective: " this procedure is reported to have a higher rate of

weight loss " .

Sugarman reports (In your CPB Reference #10) that " the

biliopancreatic diversion has had excellent weight loss results " ,

In fact, not a single author among those on your reference list (or

any others that I have found) has stated even the slightest doubt

about the efficacy of the BPD and BPD/DS procedure.

In addition, all of the seven references included report equal or

better weight loss with the BPD/DS procedure when compared to the

standard Roux-n-Y (RNY) gastric bypass. Results of the BPD procedure

without DS have shown little or no weight regain even out to 20 years

[16].

Mean excess weight loss is reported to be in the 70-80% range

[17,18,19,21]

So the efficacy of the BPD and BPD/DS procedures cannot be

questioned. The BPD and BPD/DS are the most effective procedures for

weight loss in existence today.

Safety of the BPD/DS procedure:

Having shown the efficacy, the key remaining question becomes the

safety of this procedure.

Operative and late mortality rates are shown to be comparable to

other gastric bypass procedures. [16,17].

In CPB 157 reference #13 and #14 describe one and two cases

respectively.

Grimm reports a single case of liver failure (CPB 157 reference #13)

and Langdon reports two cases of liver failure (CPB 157 reference

#14). However, Grimm reports that the patient was non-compliant and

anorexic. " She refused most oral medications prescribed in hospital,

including metronidazole " . Langdon reports one patient " refused

surgical takedown on multiple occasions " and the other patient " began

(drinking) alcohol surreptitiously " . And Grimm also reports " the

rarity of liver disease after BPD contrasts sharply with the

situation after the JI bypass … " . Hess reports that liver disease

is not a problem with this procedure [17].

Regarding morbidities, Sugarman reports in 1993 (in CPB 157 reference

#10) that " the biliopancreatic diversion has had excellent weight

loss results " , but comments on " severe protein-calorie malnutrition,

… fat soluble vitamin deficiencies, calcium loss, and iron

deficiency. " You have included an old report by Socpinaro (ref #12)

which is now 9 years out of date.

Carmichael (CPB 157 reference 26) touches only briefly on the BPD

procedure stating " This procedure is the most traumatic of all anti-

obiesity procedures and induces massive metabolic changes " . However,

the author neglects to include a single reference or give a single

clinical case to substantiate his claim.

Before addressing Sugarman's concerns I would like to point out that

CPB 157 states that " (the distal RNY procedure) combines the least -

desirable features of the gastric bypass with the most troublesome

aspects of the biliopancreatic diversion " . Yet it also states

that " Although patients can have increased frequency of bowel

movements, increased fat in their stools, and impaired absorption of

vitamins, recent studies have reported good results (for the distal

RNY). Since it is admitted that the most " troublesome " aspects of

the BPD/DS procedure are shared by the distal RNY procedure than it

follows that if the distal RNY procedure has had good results then so

too will the BPD/DS procedure.

I will discuss address each of the issues that Sugarman was concerned

with by sighting more recent literature.

Protein Malnutrition (PM).

Scopinaro reports in 1998 that increasing the mean gastric volume to

350ml reduced the incidence of PM to 15.1%. Increasing the length of

the alimentary limb to 300cm for patients with a carbohydrate rich

diet reduced the incidence of protein malnutrition to 3%.[16]

Hess reports in 1998 that 8 out of 440 patients (1.8%) undergoing the

BPD/DS patients required revisions due to protein malnutrition or

excess weight loss. Rather than choosing a fixed limb length, Hess

choose to measure the small intestine and make the alimentary limb

40% of the total intestinal length while the common channel was made

to be 10%. The mean common channel was increased from 50cm as in

Scopinaro to 75cm. [17]

Clare shows that by using equal limb lengths for the alimentary and

billio limbs, the rate of protein malnutrition drops from 8% (using

the classic 250cm/50cm Scopinaro technique) to 2%.

Marceau reports that by increasing the common channel from 50cm to

100cm, his yearly revision rate on BPD/DS is only 0.1% per year!

To summarize, the modern literature reports a PM rate between 0.1-3%.

Further, protein malnutrition is not unique to the BPD/DS procedure.

Kusher reports on a case of severe malnutrition after RNY surgery

[24].

Iron Deficiency/Anemia:

Hess reports that 9% of his patients required iron supplementation

and that " all anemia were correctable with the proper iron or

surgical therapy. Scopinaro reports that Anemia appears only in BPD

patients with chronic bleeding (menstruation, hemorrhoids, or stomal

ulcer). Baltasar reports that oral iron was insufficient in 10% of

the female patients.

Here again, anemia is not unique to the BPD/DS procedure. Halverson

reported that " anemia developed on more than one-third of the

patients " following the RNY procedure. [25]

Fat Soluble Vitamin Deficiency:

Baltasar reports " liposoluble vitamins should be monitored, but so

far none of our patients have presented deficits " .

Once again the problem of vitamin deficiency is not unique to the

BPD/DS procedure. Rhode and Brolin report problems with vitaman B12

defficiency in post RNY patients. [26,27] Buffington reports vitaman

D deficiencies in both post-operative RNY patients as well as pre-

operative. [28]

Calcium Loss:

Hess reports " these results indicate that if the patients take their

vitamin D and calcium they can maintain the proper levels and in some

cases increase their calcium and vitamin D to levels higher than

those before surgery.

Scopinaro reports " older and heavier patients showed a sharp

improvement in bone mineralization compared with the preoperative

state. " [16]

Sufficiency of data:

In your CPB 157 It is stated " … this (BPD/DS procedure) … is rarely

performed in the United States due to the high risk of various

metabolic complications. "

This is incorrect. Currently there are 30 US surgeons performing

this procedure with 18 performing it as their primary procedure.

Thousands of BPD/DS procedures are done each year. The metabolic

complication rates have dropped dramatically now that it is common

practice to make the alimentary limb length 40-50% of the total

intestinal length [17,18,19,21].

Scopinaro published a paper 3 years ago based on over 2000 patients

who underwent BPD. His report includes following patients for up to

20 years, and he claims that this is the longest longitudinal study

ever reported on in the literature! [16].

Hess reports on a series of 440 patients who underwent BPD/DS

followed up to 8 years.

Marceau reports on 465 patients who underwent BPD/DS a mean of 4.1

years prior to his report.

Baltasar reports on 125 patients who underwent BPD/DS, and Rabkin

reports on 105 patients who underwent BPD/DS.

By contrast, Dr. Wittgorve's paper on laprascopic RNY sites only 500

cases over a maximum of 5 years, and yet it is considered to be the

authoritative study on laprascopic RNY [23].

Regarding the 1991 NIH conference (CPB 157 rerference #1), the

conclusions at that time were groundbreaking. However, 10 years of

research, as well as research prior to the 1991 conference but

published after 1991 conference, have shown that some of the

conclusion of that conference need to be revised.

Specifically VBG has been shown to be rather ineffective, while

BPD/DS has been shown to be safe an extremely effective.

There now exists a large body of evidence to show that the

Billiopancreatic diversion (with or without duodenal switch) is safe

and effective. Several thousand patients have been reported on with

follow-ups as long as 20 years. The author of your policy bulletin

effectively admits that it is as safe and effective as distal RNY

(which is an approved procedure) and more effective than proximal

RNY. Over the last 3 years there have been numerous articles showing

the long-term safety and efficacy of this procedure. Those that

claim otherwise are either confusing the procedure with JIB or are

unaware of the more recent data.

1. Balsiger BM, Poggio JL, Mai J, KA, Sarr MG, Ten and

more years after vertical banded gastroplasty as primary operation

for morbid obesity, Gastrointest Surg 2000 Nov-Dec;4(6):598-605.

2. Balsiger BM et all, Prospective evaluation of Roux-en-Y

gastric bypass as primary operation for medically complicated

obesity. Mayo Clinic proc. 2000 Jul; 75(7):669-72

3. Mallory GN, Macgregor AM, Rand CS, The Influence of Dumping

on Weight Loss After Gastric Restrictive Surgery for Morbid Obesity.

Obes Surg 1996 Dec;6(6):474-478

4. Mason EE, Starvation injury after gastric reduction for

obesity, World J Surg 1998 Sep;22(9):1002-7

5. Avinoah E, Ovanat A, Charuzi I., Nutritional status seven

years after Roux-en-Y gastric bypass surgery. Surgery 1992 Feb; 111

(2):137-42

6. Sanyal AJ, Sugerman HJ, Kellum JM, Engle KM, Wolfe L.,Stomal

complications of gastric bypass: incidence and outcome of therapy, Am

J Gastroenterol 1992 Sep;87(9):1165-9

7. Brolin RE et all, Lipid Risk profile and weight stability

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8. Balsiger BM et all, Prospective evaluation of Roux-en-Y

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9. Hsu LK et all, Nonsurgical factors that influence the outcome

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10. Bloomston M et all, Outcome following bariatric surgery in

the super versus morbidly obese patients: does weight matter? Obes

Surg 1997 Oct;7(5):414-9

11. Oh CH, Kim HJ, Oh S, Weight loss following transected gastric

bypass with proximal Roux-en-Y, Obes Surg 1997 Apr;7(2):142-8

12. Reinhold Rb, Late results of gastric bypass surgery for

morbid obiesity, J Am Coll Nutr 1994 Aug;13(4):326-31

13. Brolin Re., Critical analysis of results: weight loss and

quality of data, Am J Clin Nutr 1992 Feb; 55(2 Suppl):577S-581S

14. Choban PS et all, A health status assessment of the impact of

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Friedman D; Camerini G; Baschieri G; Simonelli A, Biliopancreatic

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switch, Obes Surg 1998 Jun;8(3):267-82

18. Baltasar A; Bou R; Bengochea M; Arlandis F; Escriva C; Mir J;

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21. Rabkin RA et all, Distal gastric bypass/duodenal switch

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22. Claire MW, Equal Billopancreatic and Alimentary Libms: An

Analysis of 106 cases over 5 years, Obes Surg 1993 Aug;3(3):289-295

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26. Prophylactic iron supplementation after Roux-en-Y gastric

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27. Rohde BM et all, Treatment of Vitamin B12 Deficiency after

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