1st BCG Maintenance Series (2 of 3) & Dosage Compromise - November 6, 2008

In my last update I pointed out how it seemed Dr. Hopkins had missed the thrust of Dr. Lamm's response to his email. Differences boiled down to "AS TOLERATED" versus "UNTIL SIDE EFFECTS OCCUR." I also promised to email Dr. Lamm myself, and I expected him to reiterate his earlier guidance. I believe the email exchange and what transpired next may be of interest to most of you.

Please be advised that challenging your doctor is an exercise in delicacy. Doctors are trained to be confident, and their natural egos are given frequent boosts as they complete training and begin practice. It's important to be respectful and keep in mind that YOU have employed the Doctor as an expert in his or her field. It is a sad tribute to American culture that we so often hire experts and pay for their advice, then discard it whenever it does not suit our (often less-educated or experienced) preconceptions. In an earlier post I had suggested that both doctors could benefit from collaboration and so could both patient sets. The reaction I observed raised my awareness that THREE egos were involved in potential conflict - those of the two doctors, and MINE! Since mine is the only one I can influence, I started there. Trying to be objective and respectful, I prayed for guidance as I composed an email to Dr. Lamm. My primary goal was to summarize all relevant facts succinctly to minimize the time it would take for him to read, understand, and respond to the message. When I was finished, I waited a couple of hours and took a fresh look to reorganize and tighten it up. With I final prayer I sent the finished product, reproduced for you below:

e-Consultation Follow-Up Questions

Hello Dr. Lamm,

I completed an e-Consultation with you on September 1, 2008 (Labor Day) for T1G3 bladder cancer and your summary is attached. I shared it with my urologist (Dr. Scott Hopkins in Salt Lake City), and I asked him to contact you to reach a consensus on BGC maintenance therapy recommendations for my case.

Dr. Hopkins' standard of care is to perform a cystoscopy followed (if clear) by 3 weeks of BCG maintenance at FULL STRENGTH every 6 months for three years, then discontinue.

Your recommendation for my case was distinctly different - increased frequency and duration with reduced dosage: 3 week maintenance BCG reducing the dose to 1/3 and giving up to 3 instillations at 3, 6, 12, 18 and 24 months, then yearly to 6 years, then at 8, 10 and 12 years

Dr. Hopkins shared your reply to his email inquiry with me, which states "...it is OK to continue full strength until side effects occur."

He now plans to give 3 week maintenance BCG sessions per your frequency above at FULL dosage AS TOLERATED, then reduce to half a dose. He defined inability to tolerate as unwillingness to undertake another treatment, or urgency/discomfort making it impossible to work 2 days after instillation. We proceeded with a full dose yesterday and another is planned for next Thursday, November 6. My symptoms were bright hematuria and clots lasting from 3 to 9 hours post-instillation followed by moderate abdominal cramps and general tiredness - no fever.

I think it will be helpful if you could clarify three specific areas:

1) Is there evidence to support that a reduced dosage is as effective as a full strength dose of BCG for maintenance, or any evidence to the contrary? This is the primary area of my concern.

2) What level of side effects would indicate a reduced dosage is in order? I can certainly tolerate much worse than yesterday as an alternative to radical surgery.

3) What are the mechanics of preparing/instilling a reduced BCG dosage? I believe the clinic here has never used a reduced dose, and they may perceive some difficulty and/or risk to the staff regarding the mechanics.

If you determine that your level of involvement with my case exceeds the scope of the e-Consultation, I would be happy to provide an additional consulting fee.

Thank you for your time and consideration.

Steve Kelley

I copied my email address and added home and cell phone numbers after my name. The message was sent Friday around 1PM, and Dr. Lamm sent me the response below at 3:40PM on Sunday.

Dear Mr. Kelley,
I will respond IN CAPS in the body of your email so I don't miss anything.
Unfortunately, I am prohibited from doing any more electronic consults by my insurance carrier, so I apologize for not being able to continue to consult by email on your case.
This does no apply to face to face consultation.
Best regards,
Don Lamm, MD

> 1) Is there evidence to support that a reduced dosage is as effective as a
> full strength dose of BCG for maintenance, or any evidence to the
> contrary? This is the primary area of my concern. ABSOLUTELY,
RANDOMIZED CONTROLLED TRIALS CONFIRM EQUAL EFFICACY (Ith INTERFERON SUPERIOR EFFICACY) AND REDUCED SIDE EFFECTS
>
> 2) What level of side effects would indicate a reduced dosage is in
order? PERSONALLY, WITH YOUR SIDE EFFECTS I WOULD REDUCE THE DOSE TO 1/10TH. REDUCTION TO HALF IS INSUFFICIENT IN MY OPINION.
>
> 3) What are the mechanics of preparing/instilling a reduced BCG dosage?
ONE THIRD, ONE TENTH OR ONE WHATEVER OF THE FULL STRENGTH PREPARATION IS PLACED IN AN APPROPRIATE VOLUME TO YIELD 50 ML OF THE BLADDER INSTILLATE. MASK AND GLOVES CAN BE WORN, BUT IT IS NOT REALLY NECESSARY.

I was dismayed to see that Dr. Lamm had to discontinue his e-Consultations, as I found his advice to be very helpful. It was very generous of him to answer my questions. I checked his website and found this short note, "e-Consultation Services are no longer available." Bad news indeed for those who don't have the time or funds to travel to Phoenix to see him. As I read his email, it seemed to boil down to -
1) Evidence supports that reduced dosages are equally effective (and more effective than adding interferon, which I was not contemplating)
2) One-tenth dose for my side effects - a pronouncement that surprised both Kathryn and me.
3) Just mix it up - no big deal

I trimmed Dr. Lamm's email down to just the facts and sent the following summary to Dr. Hopkins on Sunday evening:

Dr. Hopkins,

I was concerned that there may not be a meeting of the minds between you and Dr. Lamm regarding reduced dosage BCG therapy. I believe your plan is to continue full dosage as TOLERATED, and Lamm's email to you stated "...it is OK to continue full strength until SIDE EFFECTS OCCUR."

In order to save time and ensure clarity, I asked Dr. Lamm to respond to three specific questions. He was kind enough to answer despite advice from his insurer. His response is copied below for your consideration. My only motivation is to engage in treatment that will best prevent cancer recurrence and progression in my case, not to interfere with your diagnostic and therapeutic judgment.

> From: Donald L Lamm, MD
> Date: 11/2/2008 3:41:24 PM
> Subject: Re: e-Consultation Follow-Up Questions
>
> Dear Mr. Kelley,
> I will respond IN CAPS in the body of your email so I don't miss anything. Unfortunately, I am prohibited from doing any more electronic consults by my insurance carrier, so I apologize for not being able to continue to consult by email on your case. This does not apply to face to face consultation.
> Best regards,
> Don Lamm, MD
>
> > 1) Is there evidence to support that a reduced dosage is as effective as a
> > full strength dose of BCG for maintenance, or any evidence to the
> > contrary? This is the primary area of my concern. ABSOLUTELY, RANDOMIZED CONTROLLED TRIALS CONFIRM EQUAL EFFICACY (ITH INTERFERON SUPERIOR EFFICACY) AND REDUCED SIDE EFFECTS
> >
> > 2) What level of side effects would indicate a reduced dosage is in
> order? PERSONALLY, WITH YOUR SIDE EFFECTS I WOULD REDUCE THE DOSE TO 1/10TH. REDUCTION TO HALF IS INSUFFICIENT IN MY OPINION.
> >
> > 3) What are the mechanics of preparing/instilling a reduced BCG dosage?
> ONE THIRD, ONE TENTH OR ONE WHATEVER OF THE FULL STRENGTH PREPARATION IS PLACED IN AN APPROPRIATE VOLUME TO YIELD 50 ML OF THE BLADDER INSTILLATE. MASK AND GLOVES CAN BE WORN, BUT IT IS NOT REALLY NECESSARY.
> >
> > Steve Kelley

Dr. Hopkins responded to me at 3PM on Monday...

Thank you. We will discuss how you want to proceed (dosage) when I see you
this week. See you in the next couple of days.

Scott A. Hopkins M.D.

This polite reply left a lot of room to wonder how Dr. Hopkins really felt about my "interference." I modeled a number of scenarios in my mind over the next few days, none of which was helpful. So today after prayer, devotions, and shower, I did the deep breathing exercises during the hour-long trip to the doc's office.

We were shown into the waiting room about 15 minutes late, and the nurse asked for the normal urine sample and gave me the normal instructions. "Did the doctor say anything about the dosage?" I asked. "Oh, are you the one that had the real bad reaction?" she asked in return. "No. He sent me an email saying we would discuss it based on another doctor's information," was my reply. She assured me she would check with Dr. Hopkins before preparing any BCG. About 10 minutes later he came in and sat down. I opened with an apology for being so much trouble, which he dismissed with a wave of the hand. We had about a five minute candid conversation. He felt that the published information supported that reduced dosages of one-half or one-third were equally effective, but had no idea where Dr. Lamm's one-tenth dosage came from. He also admitted there was no compelling reason to go with a full dose beyond "habit" and his patients being able to tolerate it. I reminded him of the increased frequency and duration that Lamm had recommended being a bigger factor for long-term toleration. He told me that he used to follow a two-year maintenance BCG protocol based partly on Lamm's research, and that he had recently switched to three years based on more recent research, also by Lamm. So he felt the increased schedule (out to 12 years) at my age would indeed support a reduce dosage. I suggested a compromise that we finish out the current series at full dosage, and then go to reduced dosages for the next series. He thought for a second and replied, "Tolerability and going through all three is the most important thing. What were your side effects?" I told him him (since I had excluded that part from the email I sent him), and he immediately said, "Let's go with half a dose this time, and based on how you react, we can re-evaluate next week." I liked that plan, so that's how we proceeded today.

In fairness to Dr. Lamm two things should be noted. First, his current therapeutic regimen is to perform BCG maintenance with dosages that stop just short of producing any side effects. He has gone as low as 1/60th dose that I know of. Second, he has access to more current data from his practice and studies than has been published, and Dr. Hopkins would have no way of knowing about it. Since I am not Dr. Lamm's patient, nor have I signed up to be a subject in one of his studies, I think the compromise is a reasonable way to proceed.

Gloria came in a few minutes later with my reduced dose. I asked if she was going to make fun of me, having pointed out last week that "even little girls" could take the full dose. She laughed and denied that she would consider such a thing. Since the instillate is the same volume (50cc) with half the BCG, the instillation process was not any easier. Dr. Hopkins mentioned that he had me in a vulnerable position and asked whether I was supporting Utah or TCU in tonight's football game, pointing to his bright red Utah school tie. I laughed and told him that Kathryn and I both went to Baylor, so we had no love for TCU from our Southwest Conference days.

The side effects started one hour sooner, peaked faster, are somewhat more severe. They seem to be tapering off an hour sooner. Jury is out on how long they may last. I should probably have spent less time on blog updating and paid more attention to hydrating! Signing off for now, and to the left there's a drawing of Biohazard Man dashing off to his favorite room! As with ANY graphic on the blog, you can click on it for a larger version.

Details of the side effects are posted on this BCG Maintenance #1 BACKUP PAGE.