February 19, 2018

Treatment Scores: Social Media Update: Lies Damn Lies and Medical Statistics

Our common enemy is disease. Yet, there are three kinds of lies in healthcare: lies, damn lies, and medical statistics.* Partly because of this, and partly because of the difficult mathematics, there is an 88% health illiteracy rate (Health.gov) among patients.

Just as bad, 60 – 80% of physicians don’t understand evidence-based medicine depending upon which outcome measure you use. (“Do clinicians understand the size of treatment effects? A randomized survey across eight countries,” by Bradley C. Johnston, PhD, et al.)

You should follow Treatment Scores on social media. The following trendy buzzwords can actually come true using Treatment Scores:


  1. Patient-centered care
  2. Patient engagement
  3. Patient empowerment
  4. Shared decision-making
  5. Evidence-based medicine
  6. Treatment transparency
  7. Personalized medicine
  8. Patient safety
  9. Value-based care determined by patients, doctors, and nurses
  10. Quality-based care determined by patients, doctors, and nurses
  11. Precision medicine
  12. Informed consent

We can also solve health illiteracy with Treatment Scores.

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REFERENCE
*There are three kinds of lies: lies, damn lies, and statistics. - is sometimes credited to Benjamin Disraeli or Mark Twain. We put a slant on the sentence by using medical statistics instead of statistics.

DISCLAIMERS
You must consult your own licensed physician, or other licensed medical professional, for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for informational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We DO NOT CLAIM to cure, treat, or prevent any illness or condition. Nor do our services provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (call 911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

COPYRIGHT:
Copyright © 2018 Treatment Scores, Inc. All Rights Reserved.

February 5, 2018

Solving Health Illiteracy: Pancreatic Cancer, Steve Jobs, & Smart Phones

I’m scared to death of pancreatic cancer. Celebrities like Patrick Swayze (Dirty Dancing) and astronaut Sally Ride have died from pancreatic cancer. Overall, only 1% of patients live for 10 years after being diagnosed with pancreatic cancer. Many friends of friends have died from pancreatic cancer. I hate pancreatic cancer. It's emotionally devastating.


TREATMENTS
When you get sick you need a list of treatments, and you need to know the “net treatment benefit” for each treatment (as summarized from existing medical studies). You would think it would be easy to get the “net treatment benefit” for a medical treatment, but in fact it’s nearly impossible, because the statistics are so disorganized. Also, many medical studies do not have a “control group” that compares treatment versus no treatment, or treatment versus placebo, or treatment vs. sham surgery.

There are two main kinds of pancreatic cancer, “neuroendocrine” and “adenocarcinoma.” Neuroendocrine is less common and less lethal.

There is hope. The American Cancer Society reports that even patients with stage 4, neuroendocrine, pancreatic cancer, who did not have surgery, had a 5-year survival rate of 16%. Stage 1, 2, and 3 are considered less lethal.
https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html

STEVE JOBS
I decided to focus this essay on the most curable type of pancreatic cancer, stage 1, neuroendocrine, pancreatic cancer. Stage 1 is a small cancer localized to the pancreas, and in many studies the 5-year survival is over 50% for these particular patients.

Allegedly, Steve Jobs had “stage 1 neuroendocrine pancreatic cancer.” My apologies to Steve Job’s family and friends. May he rest in peace. I have no inside information about his case, but am using what has been reported in the media, which may or may not be accurate, for learning purposes.

TREATMENTS AND TREATMENTS SCORES
Let’s say that I am diagnosed with pancreatic cancer, neuroendocrine, stage 1. Obviously, I would want to know how much each treatment would increase my 5-year survival.

I call “the net treatment benefit as summarized from the medical literature” the Treatment Score. I need a list of treatments and Treatment Scores. (See disclaimers below). Treatment Scores would fit easily on your smart phone.


In the graphic, I gave surgery a Treatment Score of 10%. I gave the chemotherapy, Gemzar® (gemcitabine), a Treatment Scores of 0%. And, I also scored many other treatments, which I will discuss.

THE NET TREATMENT BENEFIT
To figure out your income, you need the formula:

Net income = gross income – expenses. 

To figure out your medical treatments you need the formula:

Gross Benefit + side benefits – side effects = Net Benefit. 

Follow the graphic in a clockwise direction to get to go from the Gross Benefit to the Net Benefit.


Simple right? No! Figuring out the “net treatment benefit” is anything but simple, it’s complicated. It’s damn near impossible, but it shouldn’t be. Your life is at stake and your health is at risk. What could be more important?

Part of what is so difficult is that the side effects are almost all on different scales. For example, if there is a 20% rate of “delayed gastric emptying” (stomach paralysis) from surgery, you have to convert that side effect onto the 5-year survival scale before subtracting it. That means you must “weight” the side effect and convert it. You must “weight” all the side effects and convert all of them. It’s like converting your expenses in Euros, and your expenses in Pesos, etc. into US dollars, and then subtracting them to figure out your total income in US dollars.

STEVE JOBS
Much of what we might know about Steve Jobs, the former CEO of Apple, and pancreatic cancer comes from the Walter Isaacson authorized biography, Steve Jobs, published in 2012. Many great articles were inspired by Steve Job’s death (and his biography) which are worth reading.

Steve Jobs was diagnosed with pancreatic cancer in October, 2003.
http://fortune.com/2008/03/05/the-trouble-with-steve-jobs/?postversion=2008030510

Steve Jobs had surgery July, 2004.
http://fortune.com/2008/03/05/the-trouble-with-steve-jobs/?postversion=2008030510

Steve Jobs had a liver transplant in 2009.
http://healthland.time.com/2011/10/05/the-pancreatic-cancer-that-killed-steve-jobs/

Steve Jobs died in 2011.

Steve Jobs reportedly tried to treat his cancer with a “special diet.”
http://fortune.com/2008/03/05/the-trouble-with-steve-jobs/?postversion=2008030510

According to the New York Times it was a vegan diet.
http://www.nytimes.com/2011/11/01/health/hindsight-is-kind-to-steve-jobss-decision-to-delay-surgery.html

Steve Jobs may have tried acupuncture, hydrotherapy, and various other treatments.
http://www.sciencebasedmedicine.org/one-more-thing/

After his death, one physician, Dr. Robert Wascher, MD, suggested that Jobs should have tried turmeric (a spice) as a treatment.
https://www.naturalnews.com/033992_turmeric_pancreatic_cancer.html

SURGERY – “THE WHIPPLE”
The surgery for pancreatic cancer is often called the “Whipple Procedure” after Dr. Allen Whipple who invented it at Columbia Presbyterian Hospital in 1935. The medical name is “pancreaticoduodenectomy.”

Pancreatic surgery is one of the most serious and major surgeries patients can undergo. There are many potential complications. There is an excellent video, “The Whipple Procedure,” from Johns Hopkins medicine which will help you understand this massive operation:
https://youtu.be/4Zxvm3MSb8k

SURGERY - BRAGGING
The Whipple procedure is so dangerous that in the past 25% of patients used to die from the operation alone. Surgeons actually “brag” (as they should) in the medical literature about doing a series of surgeries without killing any patients.

German surgeons operated on 118 patients in row without any deaths.
https://www.ncbi.nlm.nih.gov/pubmed/2322039

Japanese physicians (Hiroshima) did 150 surgeries in row without any deaths.
https://www.ncbi.nlm.nih.gov/pubmed/18050288

Australian physicians did 178 in a row without any deaths.
https://www.ncbi.nlm.nih.gov/pubmed/21813392

Brazilian physicians did 214 in a row without any deaths.
https://www.ncbi.nlm.nih.gov/pubmed/27266408

Japanese physicians (Tokyo) did 368 in a row without any deaths.
https://www.ncbi.nlm.nih.gov/pubmed/28103418

TREATMENT – SURGERY – TREATMENT SCORE
As mentioned earlier, I gave surgery a Treatment Score of 10% as an increase in 5-year survival. It was incredibly hard to come up with a reasonable number, because the studies typically being cited are case-series studies without any controls. Stage 1, neuroendocrine, pancreatic cancer is the least lethal type, and many patients, even most patients, may live for 5 years without surgery. The range for the Treatment Score of 10% is large, because there are no controls and not enough patients (which in the future we will show with animations). Here is the background data that has to be converted and subtracted. It's main outcome - side effects = Treatment Score. You will be able to see all this, and more, on your smart phone.


It’s easy to exaggerate the benefit of medical treatments. In fact, it’s easy to lie with medical statistics, because few people understand them, and they are often flawed or biased. One physician, Dr. Birgir Gudjonsson, wrote a great paper about the situation: “Survival statistics gone awry: pancreatic cancer, a case in point.”
https://www.ncbi.nlm.nih.gov/pubmed/12172365

TREATMENT – SURGERY CONTROLS
When I started this project, I expected that surgery vs. no surgery would be a slam dunk. I thought surgery for stage 1, neuroendocrine, pancreatic cancer was wildly successful, nearly 100% successful even, but instead it’s murky. It’s hard to find any controls.

How do we control for surgery vs. no surgery? One idea is to look at 5-year survival and 10-year survival. If surgery is curing everyone at 5 years, there will be no deaths at 10 years, right? One prestigious source has 5-year survival at 61% and 10-year survival at 52%. So, 9% more patients died over the next 5 years. There is the issue of "competing mortality" however.
https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html

I tried to zero in on any controlled study I could find. I found an older one, an imperfect study, that compared surgery to medical treatment in 124 patients total, and reported that only 3% who underwent surgery developed liver metastases while 23% who had medical therapy developed liver metastases. Presumably, preventing liver metastases also prevents death from cancer. Does this mean that surgery cures about 20% of patients?
https://www.ncbi.nlm.nih.gov/pubmed/7916560

What needs to be done? There is a group of 211 patients who did not have surgery, who were stage 1, neuroendocrine, pancreatic cancer. If someone could go back and review their 5-year overall survival we could finally have a “historical” control group. This control group, or any other control group versus surgery, might turn everything we think we know about neuroendocrine pancreatic cancer upside down.
https://www.ncbi.nlm.nih.gov/pubmed/17903729

Evidence-based medicine is done to remove biases and uncertainty about medical statistics. Removing biases, removing fiction from fact is why “blinded” randomized controlled trials are done. But, they are hard to do, and we often look to other controlled studies for help. We definitely need help with understanding the true treatment effects when it comes to pancreatic cancer.

TREATMENT - SURGERY - LEAD-TIME BIAS
All of the benefit from surgery in the medical literature for stage 1 could be due to lead time bias. If you diagnose the disease earlier, in younger people than before, the 5-year survival will go up whether the treatment makes any difference or not. We see this false increase in survival all the time in cancer studies.

TREATMENT – SURGERY – OVERALL SURVIVAL
Exactly how you calculate survival makes a difference too. Are you using simple survival? 100% alive now and 50% alive in 5 years? What about people who die from heart attacks, strokes, accidents and so forth during those 5 years? People who die from things other than their cancer did not benefit from their cancer treatment, so the treatment benefit would go down. Those patients should not count as being cured of cancer, because the patient did not actually benefit. That’s why I prefer the “overall survival” statistic when I can get it. Overall survival takes these things into account, because it adjusts for “reality.”

TREATMENT - ACUPUNCTURE
I gave acupuncture a Treatment Score of NSD (No Specific Data). There are studies in human beings, but there are no studies specifically suggesting acupuncture increases 5-year survival for stage 1, neuroendocrine, pancreatic cancer. In our software, if you click on the Treatment Score, you can see the underlying references. You can verify the references, and you can see that none of them are directly applicable.

TREATMENT – FRUIT DIET
I gave eating a fruit diet a Treatment Score of NSD (No Specific Data), because although there are human studies that suggest a fruit diet may act against cancers, there are no specific human studies suggesting a fruit diet increases survival for stage 1, neuroendocrine, pancreatic cancer.

TREATMENT – HYDROTHERAPY
Hydrotherapy is “water therapy.” It is a form of alternative medicine, where water is used to treat pain or disease. I gave hydrotherapy a Treatment Score of NSD (No Specific Data), because I did not find studies specifically about hydrotherapy increasing survival for stage 1, neuroendocrine, pancreatic cancer.

TREATMENT - TANGENT
As an aside, I do not “hate” alternative medicine. Far from it! I want all medical treatments to work, and to be proven to work, because that would be best for patients. Some alternative medicine treatments, herbs, therapies, and so forth do have good, or even great, medical studies supporting their use. I just want everyone to know what the existing medical studies say for every treatment, and for that information to be presented in an understandable fashion. I also want all alternative medicines that seem to work in the laboratory, or in mice studies, to go on to be tested in human beings in a safe and ethical fashion. I also understand why someone facing death would be willing to try an herb or supplement, when there are no good specific medical studies in humans, especially if that herb or supplement is known to be harmless, and inexpensive. Let’s make WHAT WE DO KNOW perfectly clear, and let’s always present the data in an easy to understand way.

TREATMENT – JUICE FASTING
I gave juice fasting a Treatment Score of NSD (No Specific Data), because although there are human studies that suggest benefits, there are no studies that document a specific benefit for increasing survival in stage 1, neuroendocrine, pancreatic cancer.

TREATMENT – PSYCHIC THERAPY
I gave psychic therapy a Treatment Score of NSD (No Specific Data). There were definitely not any studies showing a survival benefit for stage 1, neuroendocrine, pancreatic cancer. I thought coming up with a Treatment Score for psychic therapy would be fun. Instead, it was a bit of nightmare. There are studies and surveys using human beings, but everything I could find was very off-topic and tangential.

TREATMENT – GEMZAR® (GEMCITABINE)
I gave the chemotherapy, Gemzar® (gemcitabine), a Treatment Score of 0% for 5-year survival. It’s sad, because it is one of the few chemotherapy options. However, Gemzar® may have a positive Treatment Score if you use a shorter time period such as 1-year survival, or 1-month survival. That's a future essay.

TREATMENT – PINEAPPLE
A businessman sent me an incredibly well-written, convincing, article about how pineapple cures cancer. When I dug into it, it was all based on a single laboratory study. Entire bodies of literature show over and over again why lab studies and animal studies do not translate well to human beings. I gave pineapple a Treatment Sore of NHD (No Human Data), because I could not find any human studies related to stage1 , neuroendocrine, pancreatic cancer that were relevant enough to use. There are some intriguing tangential studies with pineapple, or pineapple ingredients (bromelain), that have been done in the laboratory, so I would like to see studies done with human beings.

TREATMENT – VEGAN DIET
I gave the vegan diet a Treatment Score of NSD (No Specific Data), because I could not find any convincing human studies that once you had stage 1, neuroendocrine, pancreatic cancer a vegan diet might increase your survival. Fortunately, there is a study in the works to see if a vegan diet might increase survival in cancer:
https://www.ncbi.nlm.nih.gov/pubmed/27473726

There are studies that suggest a vegan diet might help prevent cancer. But I could not find any specific studies showing a vegan diet would help cure you once you already had this kind of pancreatic cancer.

TREATMENT – TURMERIC
I gave turmeric a Treatment Score of NHD (No Human Data). There are some very interesting laboratory studies with turmeric, so I would love to see some human studies get done. Turmeric has an ingredient, curcumin, that is featured in many laboratory studies as probably having anti-pancreatic cancer effects. Studies in human beings need to be done.

A BETTER WORLD
Wouldn’t it be a better world if there was a graphical user interface (GUI) over evidence-based medicine? Then, you could get a list of treatments and Treatment Scores for whatever you are diagnosed with. Our Treatment Scores system would help solve undertreatment, overtreatment, and mistreatment. It would educate everyone.

What would Steve Jobs have done if all of this information had been organized and ready for him on day 1 of his diagnosis? The unanswerable question is: Would he still be alive today? Remember, 9 months went by between his diagnosis and his surgery. Did the cancer metastasize (spread) and become incurable during those 9 months?

Who could blame anyone for taking some time to think before undergoing a major surgery? The problem is that it literally takes months to read all the studies, find all the medical statistics, and understand them. With Treatment Scores you can do all that in 10 minutes.

It’s frustrating! The entire medical system should be geared toward figuring out the “net treatment benefit” for the patient, but sadly it is not. Let’s change this. What would really be helpful would be a credible group of PhDs, doctors, nurses, and patients, who put patients first. We need people who are not working for Academia, Government, or Industry (or who declare their bias when they are), who produce Treatment Scores that are done transparently. That way we would not have to spend countless hours trying to understand medical treatments, and we could begin to solve the 88% health illiteracy problem.

LIMITATIONS
This essay is not claiming accuracy. It will be redone. It will be improved. Right now, it is for technique. It is about how we need to provide better treatment transparency to patients. The underlying data is highly uncertain (again, something that we will eventually show with animations). Most studies are case-series studies, which are considered low quality, and often are biased. Many assumptions have to be made. For example, I had to assume that surgery for stage 1, neuroendocrine, pancreatic cancer was somewhat similar to surgery for any stage or type of pancreatic cancer, but in theory surgery should be somewhat less risky when the disease is not as advanced.

HELP
The old way is not working. We have an 88% health illiteracy rate (Health.gov). We need experts working on Treatment Scores. If you want to HELP US help patients understand the “net treatment benefit” please email me at Dr.Hennenfent@gmail.com

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DISCLAIMERS
This essay is not medical advice. You must consult your own licensed physician for diagnosis, treatment, and for the interpretation of all medical statistics including Treatment Scores. Treatment Scores are for informational purposes only. Treatment Scores may be incomplete, inaccurate, harmful, or even cause death if used for treatment instead of consulting a licensed medical professional. No medical advice is being given. We (everyone, and every entity, involved in any way) DO NOT claim to cure, treat, or prevent any illness or condition. We DO NOT provide medical advice or constitute a physician patient relationship. Contact a physician or other medical professional if you suspect that you are ill. Call emergency services (911 if available) or go to the nearest emergency room if an emergency is suspected. We are not responsible for any delays in care from using our essay, website, our services, or for any other reason. We are not responsible for any consequential damages of any nature whatsoever. We make no warranties of any kind in connection with our writings or the use of TreatmentScoresBlog.com or TreatmentScores.com. Treatment Scores are about what happened to patients studied in the past; they do not predict the future.

REFERENCES - BEGINNING
Cancer Research UK, (source for 1% survival statistic).
http://www.cancerresearchuk.org/health-professional/cancer-statistics/survival/common-cancers-compared#heading-Zero
Accessed January 22, 2018.

Pancreatic Cancer Survival Rates, by Stage. Last Revised: May 31, 2016.
https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html
Accessed January 26, 20018.

Ranker.com (Source for celebrity deaths)
https://www.ranker.com/list/famous-people-who-died-of-pancreatic-cancer/reference
Accessed January 25, 2018.

Columbia Surgery: History of Medicine: Whipple's Improvised Breakthrough
http://columbiasurgery.org/news/2015/11/12/history-medicine-whipples-improvised-breakthrough
Accessed January 25, 2018.

REFERENCES - LYING WITH STATISTICS
Gudjonsson, Birgir. “Survival statistics gone awry: pancreatic cancer, a case in point.”
J Clin Gastroenterol. 2002 Aug;35(2):180-4.
https://www.ncbi.nlm.nih.gov/pubmed/?term=12172365

REFERENCES - STEVE JOBS
The Pancreatic Cancer That Killed Steve Jobs, by Alice Park. TIME Magazine.
http://healthland.time.com/2011/10/05/the-pancreatic-cancer-that-killed-steve-jobs/
Accessed January 25, 2018.

The trouble with Steve Jobs, by Peter Elkind, FORTUNE, March 5, 2008.
http://fortune.com/2008/03/05/the-trouble-with-steve-jobs/?postversion=2008030510
Accessed January 25th, 2018.

A Tumor Is No Clearer in Hindsight, by Denise Grady. Oct. 31, 2011.
http://www.nytimes.com/2011/11/01/health/hindsight-is-kind-to-steve-jobss-decision-to-delay-surgery.html
Accessed January 25th, 2018.

The early detection of cancer and improved survival: More complicated than most people think, by David Gorski, May 12, 2008.
http://www.sciencebasedmedicine.org/one-more-thing/
Accessed January 1, 2018.

Turmeric spice could have cured pancreatic cancer that killed Steve Jobs, suggests oncologist, by Jonathan Benson. October 27, 2011, Natural News.
https://www.naturalnews.com/033992_turmeric_pancreatic_cancer.html
Accessed January 25th, 2018.

REFERENCES - TURMERIC
Curcumin Induces Autophagy, Apoptosis, and Cell Cycle Arrest in Human Pancreatic Cancer Cells.
https://www.ncbi.nlm.nih.gov/pubmed/29081818

Curcumin sensitizes pancreatic cancer cells to gemcitabine by attenuating PRC2 subunit EZH2, and the lncRNA PVT1 expression.
https://www.ncbi.nlm.nih.gov/pubmed/29048549

Inhibition of Cell Survival by Curcumin Is Associated with Downregulation of Cell Division Cycle 20 (Cdc20) in Pancreatic Cancer Cells.
https://www.ncbi.nlm.nih.gov/pubmed/28165402
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331540/

Curcumin-Free Turmeric Exhibits Activity against Human HCT-116 Colon Tumor Xenograft: Comparison with Curcumin and Whole Turmeric.
https://www.ncbi.nlm.nih.gov/pubmed/29311914

REFERENCES – SURGERY WITHOUT DEATHS
Trede M, Schwall G, Saeger HD. Survival after pancreatoduodenectomy. 118 consecutive resections without an operative mortality. Ann Surg. 1990 Apr;211(4):447-58. Department of Surgery, Klinikum Mannheim, Heidelberg University, West Germany.
https://www.ncbi.nlm.nih.gov/pubmed/2322039

No mortality after 150 consecutive pancreatoduodenctomies with duct-to-mucosa pancreaticogastrostomy. J Surg Oncol. 2008 Mar 1;97(3):205-9.
Murakami Y1, Uemura K, Hayashidani Y, Sudo T, Hashimoto Y, Nakagawa N, Ohge H, Sueda T. Department of Surgery, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.
https://www.ncbi.nlm.nih.gov/pubmed/?term=18050288

One hundred and seventy-eight consecutive pancreatoduodenectomies without mortality: role of the multidisciplinary approach. Hepatobiliary Pancreat Dis Int. 2011 Aug;10(4):415-21. Samra JS1, Bachmann RA, Choi J, Gill A, Neale M, Puttaswamy V, Bell C, Norton I, Cho S, Blome S, Maher R, Gananadha S, Hugh TJ. Upper Gastrointestinal Surgical Unit, University of Sydney, Royal North Shore Hospital, St Leonards, NSW 2065, Sydney, Australia.
https://www.ncbi.nlm.nih.gov/pubmed/?term=21813392

Laparoscopic Pancreatoduodenectomy in 50 Consecutive Patients with No Mortality: A Single-Center Experience. J Laparoendosc Adv Surg Tech A. 2016 Aug;26(8):630-4. Machado MA, Surjan RC, Basseres T, Silva IB, Makdissi FF.
Department of Surgery, University of São Paulo , São Paulo, Brazil .
Sírio Libanês Hospital, São Paulo, Brazil .
https://www.ncbi.nlm.nih.gov/pubmed/?term=27115329

Systematic use of isolated pancreatic anastomosis after pancreatoduodenectomy: Five years of experience with zero mortality. [214 patients] Eur J Surg Oncol. 2016 Oct;42(10):1584-90. doi: 10.1016/j.ejso.2016.05.023. Epub 2016 May 29.
Machado MC, et al. Eur J Surg Oncol. 2016.
https://www.ncbi.nlm.nih.gov/pubmed/?term=27266408

Three hundred and sixty-eight consecutive pancreaticoduodenectomies with zero mortality. Oguro S, et al. J Hepatobiliary Pancreat Sci. 2017. Oguro S1, Yoshimoto J1, Imamura H, Ishizaki Y, Kawasaki S.
Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan.
https://www.ncbi.nlm.nih.gov/pubmed/?term=28103418

Systematic use of isolated pancreatic anastomosis after pancreatoduodenectomy: Five years of experience with zero mortality. [214 patients] Eur J Surg Oncol. 2016 Oct;42(10):1584-90. doi: 10.1016/j.ejso.2016.05.023. Epub 2016 May 29.
Machado MC, et al. Eur J Surg Oncol. 2016.
https://www.ncbi.nlm.nih.gov/pubmed/?term=27266408

REFERENCES – SURGERY URLS
Here is a sample of surgery-related URLS:

http://www.ncbi.nlm.nih.gov/pubmed/25885408
https://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html
https://www.ncbi.nlm.nih.gov/pubmed/11088073
https://www.ncbi.nlm.nih.gov/pubmed/12192322
https://www.ncbi.nlm.nih.gov/pubmed/17903729
https://www.ncbi.nlm.nih.gov/pubmed/25885408
https://www.ncbi.nlm.nih.gov/pubmed/28341868
https://www.ncbi.nlm.nih.gov/pubmed/28464575
https://www.ncbi.nlm.nih.gov/pubmed/28895142
https://www.ncbi.nlm.nih.gov/pubmed/29019886
https://www.ncbi.nlm.nih.gov/pubmed/9339931

REFERENCES – ACCUPUNCTURE
Here is a sample of acupuncture related URLs.

https://www.ncbi.nlm.nih.gov/pubmed/24280575
https://www.ncbi.nlm.nih.gov/pubmed/4808622
https://www.ncbi.nlm.nih.gov/pubmed/26100066

REFERENCES – FRUIT DIET
Here is a sample of fruit diet related URLs:

http://www.ncbi.nlm.nih.gov/pubmed/17524168
https://www.ncbi.nlm.nih.gov/pubmed/11678487
https://www.ncbi.nlm.nih.gov/pubmed/15316829

REFERENCES – HYDROTHERAPY
Here is a sample of URLs about hydrotherapy:

https://www.ncbi.nlm.nih.gov/pubmed/13680321
https://www.ncbi.nlm.nih.gov/pubmed/7992595
https://www.ncbi.nlm.nih.gov/pubmed/7483377
https://en.wikipedia.org/wiki/Hydrotherapy

REFERENCES – JUICE FASTING
Here is a sample of “Juice Fasting” URLs:

https://www.ncbi.nlm.nih.gov/pubmed/16131283
https://www.ncbi.nlm.nih.gov/pubmed/26176887
https://www.ncbi.nlm.nih.gov/pubmed/21086570
https://www.ncbi.nlm.nih.gov/pubmed/28216454

REFERENCES – PSYCHIC THERAPY
Sampling of URLs somewhat related to psychic therapy:

https://www.ncbi.nlm.nih.gov/pubmed/21549256
https://www.ncbi.nlm.nih.gov/pubmed/25685187
https://www.ncbi.nlm.nih.gov/pubmed/11824916
https://www.ncbi.nlm.nih.gov/pubmed/7931113
https://www.theguardian.com/science/2009/may/12/psychic-claims-james-randi-paranormal
https://www.ncbi.nlm.nih.gov/pubmed/25685187

REFERENCES - GEMZAR® (GEMCITABINE)
Here are some URLs about Gemzar® and neuroendocrine cancer:

https://www.ncbi.nlm.nih.gov/pubmed/24413782
https://www.ncbi.nlm.nih.gov/pubmed/15329900
https://www.ncbi.nlm.nih.gov/pubmed/20698050

REFERENCES – PINEAPPLE
Here are some sample URLs about pineapple:

https://www.ncbi.nlm.nih.gov/pubmed/23137025
https://www.ncbi.nlm.nih.gov/pubmed/17893836
https://www.ncbi.nlm.nih.gov/pubmed/10552641
https://www.ncbi.nlm.nih.gov/pubmed/20713174
https://www.ncbi.nlm.nih.gov/pubmed/12565169
https://www.ncbi.nlm.nih.gov/pubmed/25820875
https://www.ncbi.nlm.nih.gov/pubmed/24123777
https://www.ncbi.nlm.nih.gov/pubmed/28157162
https://www.ncbi.nlm.nih.gov/pubmed/22191568
https://www.ncbi.nlm.nih.gov/pubmed/19700238

REFERENCES – TURMERIC
Here are some sample references about turmeric:

https://www.ncbi.nlm.nih.gov/pubmed/29311914
https://www.ncbi.nlm.nih.gov/pubmed/28165402
https://www.ncbi.nlm.nih.gov/pubmed/28259961
https://www.ncbi.nlm.nih.gov/pubmed/28535906
https://www.ncbi.nlm.nih.gov/pubmed/29081818
https://www.ncbi.nlm.nih.gov/pubmed/29048549

REFERENCES – URLS GENERAL
https://www.ncbi.nlm.nih.gov/pubmed/28529726
https://www.ncbi.nlm.nih.gov/pubmed/7916560
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1234386/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4982911/
https://www.ncbi.nlm.nih.gov/pubmed/27473726
https://www.ncbi.nlm.nih.gov/pubmed/27101764
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4844163/
https://www.ncbi.nlm.nih.gov/pubmed/26657045


EBM® Treatment Scores

SOM® Treatment Scores

January 18, 2018

The Net Treatment Benefit of the Mumps Measles & Rubella (MMR) Vaccine

When figuring out the benefits of the mumps, measles, & rubella vaccine, you need to use evidence-based medicine, medical ethics, and shared decision-making. The official name of the vaccine in use in the United States is M-M-R® II, which I will abbreviate as MMR II. Interestingly, you can use the exact same data to be pro-vaccine or anti-vaccine (for this particular vaccine). It depends on the assumptions you make, and the ranges of the data points. Surprisingly, you have to make assumptions, because there are no adequate randomized controlled studies (RCTs).

I’m a 15-month-old fictional toddler named Olivia. I’m telling this story because I’m the patient (you need to suspend your disbelief and assume a 15-month old can do all of this). Evidence-based medicine and medical ethics state that:

1. The patient comes first
2. Patient-Important Outcomes should be used
3. Patient-Centered Outcomes should be used
4. Patient safety is paramount
5. The patient’s values and preferences must be taken into account
6. The patient deserves complete transparency.


TREATMENT SCORES
I, (15-month old Olivia) try to make medical treatments understandable. Usually, you give me a diagnosis and I come up with a list of treatments for that diagnosis with Treatment Scores.

The Treatment Score is defined as the:

“Net treatment benefit for the patient as summarized from the existing medical literature. It is determined by shared decision-making between you and your physician.”

One can see why it’s simpler to call it the “Treatment Score,” or the “net treatment benefit.” The Treatment Score is a way to summarize the “net treatment benefit” for the patient down to one number. I (baby Olivia) got tired of the fact that 88% of the population is health illiterate (Health.gov). For example, people do not understand that a chemotherapy can have a Treatment Score of zero, because that chemotherapy does not increase survival, which happens far more often than you would think.

People also do not understand than an “alternative medicine” can have a Treatment Score of “no data,” because there are no clinical studies of human beings undergoing that treatment. Similarly, people often disregard all “alternative medical treatments” as being bogus, when in fact, sometimes alternative medicines do have good studies to support them. We need a solution to all the confusion. We need Treatment Scores.

THE DIAGNOSIS
The diagnosis is “mumps, measles, and rubella prevention,” but we need to be more specific by making the diagnosis “mumps, measles, and rubella prevention in the United States.” Location turns out to be very important when it comes to risks and benefits.


TREATMENT
The treatment list turns out to be very short. Essentially, the only treatment available to prevent mumps, measles, & rubella (all three at once) is the MMR II vaccine. Having basically only one treatment is unlike other diagnoses such as “migraine headache,” which has 57 treatments, or “insomnia,” for which there are 130 treatments. I am currently unaware of any other treatment that allegedly prevents all three childhood diseases simultaneously, with the possible exception of “improving overall health.”

OUTCOME MEASURE
What is the most important outcome measure for me, a 15-month old toddler? This is where it gets interesting. There are a dizzying number of different outcome measures used in the medical literature. I (Olivia, think of me as an animated cartoon talking to you) am worried about two things:

1. Will the MMR II vaccine prevent me from dying?
2. Will the MMR II vaccine prevent from me from suffering permanent disability from mumps, measles, or rubella?

Here is a treatment list:


One treatment is to do nothing and suffer the “natural history” of measles, measles, or rubella if I should contract any of them. One treatment is to take a placebo (a do-nothing pill) and see if I have a “placebo effect” that magically prevents mumps, measles, or rubella. The treatment I am focusing on now is the MMR II vaccine. My last idea (as an unreal educated toddler) might be to look into any clinical trials that are being done on new treatments to prevent mumps, measles, and rubella.

MAIN OUTCOME MEASURE – MY CHOICE
I will one day grow up to be a strong independent woman, so I am choosing the single most important outcome measure to me: overall survival. Specifically, I am choosing “5-year overall survival.” I want to know how much my “5-year overall survival” will increase if I take the MMR II vaccine. I want to know about “absolute” increases not “relative” increases, because it is easy to exaggerate, mislead, or outright lie with relative numbers.

“There are three kinds of lies: lies, damn lies, and statistics.” – Benjamin Disraeli

“Five-year overall survival” is the best outcome measure for me, because I (the fictional toddler patient) chose it using shared decision-making with my physician, and my parents. That’s how evidence-medicine is supposed to work. Both evidence-based medicine and medical ethics say we are supposed to consider the patient’s “values and preferences.”

“When determining the optimal treatment choice based on the relative benefits and harms of a therapy, the values and preferences of each individual patient must be considered.” – Dr. Gordan Guyatt, et al. (Users' Guides to the Medical Literature: A Manuel for Evidence-Based Clinical Practice 3rd Ed. Page 71).

“Five-year overall survival” is important to me because of “the measles situation.” Measles is the most likely of the three diseases to kill me. And, when measles kills kids, it mostly kills kids who are less than 5-years-old.

“Five-year overall survival” is also a good choice because there is good data about the number of cases of mumps, measles, and rubella that have occurred in the last 5 years.

I also like “5-year overall survival” as my main outcome measure, because it’s a standard time period in medicine when it comes to other diseases such as cancer. Imagine that someone does a randomized controlled trial (RCT), and some patients get placebo pills and other patients get chemotherapy. After 5 years 95% of the patients who got chemotherapy are still alive and 0% of the patients who got placebo are still alive. That 95% difference in 5-year survival is important. That treatment really works!

One last reason to like 5-year overall survival is that there is a general body of medical literature about children from 0 to 5 years old (0 to 60 months).

QUESTIONS I NEED ANSWERS TO
Remember, I am a fictional 15-month old toddler, who is precocious, brilliant, and highly educated.

What will my 5-year overall survival be if take the MMR II vaccine?
What will my 5-year overall survival be if I don’t take the MMR II vaccine?
What will be the difference between the two?

LIFETIME SURVIVAL
Eventually, I really want to know “lifetime overall survival” as well as 5-year overall survival, because mumps, measles, and rubella can affect the young, the old, and the unborn, but that analysis will have to wait for a future essay.

TREATMENT SCORES – WHY?
There is an 88% health illiteracy rate (https://health.gov/communication/literacy/issuebrief/). One way to solve the health illiteracy problem is to summarize a medical treatment down to one number, the net treatment benefit for the patient, which I call the Treatment Score.

SABERMETRICS
In medicine, I often see statistics that do not put the patient first. What the patient needs to know is the net treatment benefit for them. I see all kinds of confusing statistics being given instead of what I (and you) really need to know, the NET TREATMENT BENEFIT.

A great example of the change we (all of us patients) need is Sabermetrics. Sabermetrics was invented for baseball by Bill James. Sabermetrics basically says, “Dear baseball managers, you are using the wrong statistic. This is the statistic, you should be using: runs created.” This concept helped start a revolution in baseball. We need to do the same in medicine. We need to digest all the information down to one number, the Treatment Score, which is the net benefit for the patient. (Animations can be used to show ranges and uncertainty as necessary.) You should watch the movie Moneyball, starring Brad Pitt, which is about Sabermetrics.

ANALOGY - INCOME
Think of your income. You need to know your gross income every year, but more importantly your net income:

Gross income – expenses = net income.

With medical treatments, you need to start with the “gross treatment benefit” and figure out the “net treatment benefit.”

Gross treatment benefit – side effects = net treatment benefit.

It’s more complicated with medical treatments, because there can be “side benefits” as well as negative “side effects” from a medical treatment. A medical treatment might save your life, but it also might save you from disability. So, the formula becomes:

Gross treatment benefit + side benefits – side effects = net treatment benefit.

We need to organize the numbers like this:


I work in a clockwise direction. I find the “gross treatment benefit” and put it top left. I find the “positive side benefits” (green zone) and put them top right. I put the “negative side effects” (red zone) bottom right, and I calculate the net benefit at the bottom left. The net treatment benefit is what the patient needs to know. It is the most important statistic for the patient.

TREATMENT SCORE CALCULATOR™
It’s time to gather some statistics about the MMR II vaccine into the Treatment Score Calculator™ below. The main outcome measure, increase in 5-year overall survival (as a percentage) goes on the left, and the “secondary outcome measures” (also in percentages) such as positive side benefits” (green zone) and negative side effects (red zone) go on the right.


This arrangement is the secret to understanding medical treatments. First, I organize the important statistics, and then second, I summarize them down to one number. We all need to do this for all medical treatments. We need to do this calculation using the medical literature, but also our own values and preferences. The main outcome on the top left is the same as the “gross benefit.” The top right is the “side benefits.” The bottom right is the “side effects.” The bottom left is the “net treatment benefit,” which is the same thing as the Treatment Score. Every statistic in the calculator is a percentage.

The numbers on the right come from sources available to most people on the Internet. I (your fictional toddler) searched PubMed and Google Scholar. I looked at WHO, CDC, UNICEF and FDA data and tried to find the original sources. You need to double check my numbers and improve them whenever possible. For example, I know that the side effect rate of 0.005% for “injection pain, redness, or swelling” must be too low, but I can’t find a better source. People who do studies often ignore the “small side effects” so they don’t collect good information for us patients. But as a patient, I want to know about any pain or suffering a treatment will cause me. Maybe the true number is out there somewhere, but so far, I have not found it.

CALCULATION 1 – THE MAIN OUTCOME MEASURE
The first thing we need is the increase in overall survival, which is the gross treatment benefit, and goes in the top left of our calculator. It’s a very surprising number. The increase in 5-year overall survival for me, personally, taking the MMR II vaccine is so close to zero in the USA it rounds to zero in my calculator. Other medical treatments are not like this. Vaccines are special because of their “invisible benefits.”

Look around. Do you see anyone dying of mumps, measles, or rubella? You could say that the mumps, measles, and rubella vaccine is a victim of its own success. Two of the three diseases have been “declared eliminated” from the USA.

Mumps was almost eliminated from the USA in 2000. There were only 338 reported cases in 2000.
https://www.cdc.gov/vaccines/pubs/surv-manual/chpt09-mumps.html

Measles was declared eliminated from the USA in 2000.
https://www.cdc.gov/measles/about/faqs.html

Rubella was declared eliminated from the USA in 2004.
https://www.cdc.gov/rubella/about/in-the-us.html

RULE OF VACCINES - 1
The better a vaccine works the more the benefits seem to disappear.

By almost eliminating mumps, measles, and rubella from the USA, the direct overall survival benefit seems to disappear for the individual patient. If you get vaccinated, your personal overall survival will not increase but by a very tiny fraction, because the diseases mostly don’t exist.

“There have been no mumps related deaths reported in the United States during recent mumps outbreaks.”
https://www.cdc.gov/mumps/hcp.html

The last confirmed measles death in the USA was in 2015.
https://www.doh.wa.gov/Newsroom/2015NewsReleases/15119WAMeaslesRelatedDeath

One infant died from rubella in 2012.
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6212a3.htm

CALCULATION 2 – (HERD IMMUNITY DISABILITY PREVENTION)
Catching the mumps can make you sick with fever, aches, pain, swelling of the salivary glands, tiredness, and headache. Rare serious side effects including deafness or encephalitis (inflammation of the brain) can happen.
https://www.cdc.gov/mumps/hcp.html

Catching measles can kill you. Measles can also cause diarrhea, ear infections, pneumonia, encephalitis, and seizures.
https://www.cdc.gov/vaccines/pubs/pinkbook/meas.html

Rubella causes pregnant women to lose their babies via spontaneous abortions or stillbirths (https://www.cdc.gov/rubella/about/in-the-us.html).

Rubella also causes babies to be born severely disabled with congenital rubella syndrome (CRS). These babies can have deafness, heart problems, cataracts of the eyes, mental retardation, and premature death.
https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6212a3.htm

What is the value of stopping the complications from mumps, measles, and rubella? We will come back to this number later. For now, I leave it as “not scored.”

CALCULATION 3 – HERD IMMUNITY (DEATH PREVENTION)
Preventing death is the most important thing the MMR II vaccine can do.

Herd immunity can protect our families and friends from death and disability, because we interact with them the most. It can also protect strangers and entire communities.

There is no huge randomized controlled trial (RCT) that perfectly represents the value of herd immunity in preventing death. Instead there are lower quality studies, such as cohort studies, case-control studies, and survey studies. All such studies have flaws and biases.

All survival studies need to control for the “improving nutrition” and “increasing standard of living” which occurs around the world, because those things also increase survival. We have to look for the most recent studies, but there are no perfect studies.

The best available number for the increase in overall survival for the MMR II vaccine that I could find looked at the measles vaccine alone, as measles is the deadliest of the three diseases: mumps, measles, and rubella. I could not find good survival data for all three combined.

How much have I (a toddler named Olivia) already benefitted from the herd immunity of the past 5 years? How much have I benefited in 5-year overall survival today due to the MMR II vaccine before it’s even my turn (to take it or not)?

My preferred study for all-cause mortality found a 2.4 percentage increase in the probability of a child’s survival to 60 months due the measles vaccine (http://jhr.uwpress.org/content/50/2/516.abstract). So, 2.4% was the value I put in the calculator for the side benefit of herd immunity (death prevention).

ANALOGY – CURRENCY EXCHANGE
In the graphic above, think of the main outcome measure, the “gross treatment benefit,” on the top left as being in US dollars. Then, think of the negative side effects on the lower right as being in other currencies, such as pesos, euros, rupees, and rubles. The side effect statistics are “event rates.” It’s the rate that a side effect such as fever occurs in patients after taking the MMR II vaccine (hopefully compared to unvaccinated controls).

When you go to a currency exchange, you convert one currency into another using the “exchange rate.” The exchange rate is different for every currency. The exchange rate “weights” the different currencies in order to exchange them into dollars. The same thing needs to be done with side effects to get them on the same scale as the main outcome measure. Once converted, the negative side effects can be subtracted to get to the net treatment benefit, which we call the Treatment Score.

NEGATIVE SIDE EFFECT - FEVER
The medical literature suggests that there is a 10% chance of getting a fever after the MMR II vaccine. Our main outcome is “5-year overall survival.” How do we get the side effect of fever on that scale so we can subtract it? Sometimes we can use data from studies, and we should always ask the patient. This type of thing is done in medicine - side effects are converted into things called “quality-adjusted life-years.” It’s just not done often enough, and too often the patient’s opinion does not count, but it should, because your personal opinion may be different than the average person’s.

My personal opinion is that getting a fever after an MMR II shot is not a huge negative, because it’s temporary, and can be treated. Getting a fever is “weighted” very low in terms of converting it as a side effect to be subtracted from 5-year overall survival. Five years is 60 months; 60 months is 1,825 days. I just roughly calculated that, for me, with my weighted conversion, this would only be like losing 20 minutes of survival from 5-years (43,800 hours) of overall survival.

NEGATIVE SIDE EFFECT – FEBRILE SEIZURE
Getting a febrile seizure after the MMR II vaccine is more worrisome to me. I ended up putting the event rate at 0.16% (https://www.ncbi.nlm.nih.gov/pubmed/15265850) into my calculator. That means about 1.6 kids out of 1,000 will have a febrile seizure. Getting a febrile seizure is worse to me than just getting a fever, so I will weight it more heavily, using my values and preferences, and subtract this negative side effect from the gross benefit of the MMR II vaccine.

NEGATIVE SIDE EFFECT – EPILEPSY
Epilepsy is scary. A percentage of children get a fever. A percentage of those children have a febrile seizure. And, a percentage of those children go on to have epilepsy (seizures for life). In theory, this stair-step of complications can occur after measles, or can occur after the measles vaccine. The measles vaccine is a live attenuated vaccine, so getting the vaccine is sometimes like getting a weak case of measles. The studies I used placed this possible side effect of the MMR II vaccine at less than 1 in a million, so it shows up as zero in our calculator (we may need to fix this rounding in future versions).

Any child who might be predisposed, or at genetic risk for fever, febrile seizures, or epilepsy should have special consultation before getting the MMR II vaccine. A DNA test is reportedly in the works to test for this tendency.

NEGATIVE SIDE EFFECTS – SERIOUS & RARE
The bottom right of my calculator contains some potentially serious side effects of the MMR II vaccine that are so rare they round to zero. They are things like: deafness, epilepsy, brain damage, encephalitis, encephalopathy, and serious allergic reaction. They are especially rare if your control group is children who do get mumps, measles, and rubella instead of your control group being simply unvaccinated children.

AUTISM – THE ELEPHANT IN THE ROOM
Does the MMR II vaccine cause autism? Maybe. Maybe not.

One study, retrospective cohort study, of 537,303 children in Denmark (http://www.nejm.org/doi/pdf/10.1056/NEJMoa021134) did not find a higher rate of autism in children who got vaccinated for mumps, measles and rubella.

TWO AUTISM CONTROVERSIES
Who do you believe when it comes to autism as a side effect to the MMR vaccine? These two groups represent the controversies:

1. Former British gastroenterologist Andrew Wakefield; Family Medicine physician Rachael Ross, MD, PhD; Pediatrician Jim Sears, MD; and CDC whistleblower Dr. William Thompson. They are all in the movie, Vaxxed.

2. The other side of the controversy is represented by many in the three entities of Academia, Government, and Industry. One autism – vaccine paper was retracted:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(97)11096-0/abstract

Because the side effect of autism is so hotly debated, I did not add it into my calculations. I dived deep into several studies and still did not feel certain about an “event rate” for autism. But, if in your review of the medical studies, you have found a number that you believe is accurate, you can add it into the calculations. That is the beauty of calculating the “net treatment benefit” using the patient’s own ability to understand science, and the patient’s own values and preferences. You can make calculations yourself. You can then assess the risks and benefits with your physician.

UNCERTAINTY IN THE NUMBERS
This essay is a flawed first attempt to quantify the net treatment benefit for the patient from the MMR II vaccine as a Treatment Score, but it is the future. There is a lot of uncertainty in the numbers, because vaccine studies are usually not the Gold Standard: randomized controlled trials, but rather are lesser quality cohort studies, case-series studies, and survey studies. Researchers are learning from the past; however, and are doing better, and larger, studies over time.

Yet, the fact remains that there is uncertainty in all the underlying numbers. There is disagreement about death rates (how often people die if they get one of these diseases) and in the negative side effect rates from the MMR II vaccine.

The MAJOR POINT is that the numbers should be shared with you, and you should decide step-by-step with your physicians and nurses, which numbers come from the most credible sources. You should be able to calculate the net treatment benefit using your judgement by doing shared decision making with your doctors and nurses. That is how to do true informed consent. Part of medicine is dealing with missing data, biased data, and low-quality data.

From our textbook of evidence-based medicine talking about patient decisions:

“They therefore involve value and preference judgments, and it is the preferences of the individual patient that must drive the decision. When the trade-off between desirable and undesirable consequences is a close one, the best—some would argue the only—way to ensure the chosen course of action is right for the individual is through shared decision making.” - Dr. Gordon Guyatt, et al. Users' Guides to the Medical Literature: A Manuel for Evidence-Based Clinical Practice 3rd Edition. Page 83.

Because of the assumptions, uncertainty, and biases in the numbers, and the difficulty in doing the “net treatment benefit” analysis this first time around, the lesson of this essay is not the specific Treatment Score, but the techniques we all need to start using to figure out the net benefits of medical treatments.

MEDICAL ETHICS - WHO HOLDS THE CARDS?
Who decides the ethics? Obviously, the patient does. It’s the patient's life at stake; it’s the patient's health that is at risk. The Hippocratic Oath and the Nuremberg Code put the patient first. Decisions need to be made between the patient and physician with complete transparency: price transparency and product transparency. Product transparency means using patient-centered outcomes. Transparency also means figuring out the net treatment benefit for the patient using shared decision-making.

PLAYING GOD 1 - PATERNALIST MEDICINE IS BAD
Medical ethics says playing God is bad. Patients’ values and preferences must be considered in order to be ethical. The Greatest Generation was sometimes paternalistic to patients, because there was no Internet. Patients were like children, totally dependent on doctors for their medical information. Paternalistic medicine was bad, because in the old days, mostly male doctors were telling patients what to do. This resulted in the epidemic of unnecessary hysterectomies for example.

PLAYING GOD 2 – GUIDELINES AND CONVENTIONAL WISDOM
After the Internet, paternalistic medicine underwent a shift. Instead of the individual physician telling the patient what to do, groups with “authority” and groups with “eminence” started telling physicians what to do, and then physicians told patients what to do. It became paternalism one-step removed. Once again, patients were left out.

The reasoning for this “group type” of paternalist medicine was that, despite having information on the Internet, you, the patient, were felt to be incapable of understanding medical information. Experts with authority and eminence decided they must make medical decisions for you. This gave rise to “guidelines” or “conventional wisdom” provided by authorities and eminent people. Authorities and eminent people told the doctor what to do, and then the doctor told you what to do.

Because unbiased randomized controlled trials (RCTs) are hard to do, we sometimes rely only on authority figures and eminent people using low quality studies. This probably led to a recent epidemic of unnecessary shoulder surgeries.
http://www.thelancet-press.com/embargo/shouldersurgery.pdf

The reaction to “authority-biased medicine” and “eminence-biased medicine” is that patients, doctors, and nurses should be doing shared decision-making with better transparency for all. It’s a new world. I (toddler Olivia) am growing up in a STEM world. I will grow up to be independent, smart, and capable. I will utilize the best information in conjunction with the smartest doctors and nurses I can find to make my own medical decisions. My generation will help democratize medical science.

CONFLICTS OF INTEREST
I study the Conflict of Interest Declarations at the bottom of medical studies, as have my parents before me, and my grandfather before that, and we have noticed something very important. Conflict of Interest Declarations are self-delusional.

Conflicts of interest are caused by money or power. The money can be direct or indirect; it can be cash or it can be goods or services. Therefore, money or power need to be disclosed whether they come from Academia, Government, or Industry. Those three entities: Academia, Government, and Industry are sometimes called the Triple-Helix, as in a medical ethics book entitled: Trust and Integrity in Biomedical Research: The Case of Financial Conflicts of Interest (Edited by Thomas H. Murray and Josephine Johnston. The Hastings Center. New York, 2010).

At the end of many medical studies you see statements like these:

“The author declares no conflict of interest” or
“The authors declare that there are no conflicts of interest.”

Search those phrases and you will find millions of examples. Medical ethics are clear that conflicts of interest in medicine are caused by three entities (in alphabetical order): 1. Academia. 2. Government, and 3. Industry.

Academia is biased because they must “publish or perish,” defend the status quo, succumb to peer pressure, and so on. Government is biased because politics come into play, and because Governments are extremely powerful. When governments make a mistake, those mistakes can be huge. Need I mention the Tuskegee experiment, or later Tuskegee-like experiments? Industry can be biased because companies need to make money to survive.

Almost every author’s declaration should at least say, “I have directly or indirectly been influenced by Academia, Government, or Industry.” Most declarations should be more specific and should add details that go back over the entire lifespan of the author. “Bias begins at birth” according to many medical studies.

HEALTH ILLITERACY & PERSPECTIVE
We have already pointed out the 88% health illiteracy rate in the USA. Physicians have the same illiteracy problem when it comes to medical statistics. In a study of 531 physicians at teaching institutions around the world, 60% to 80% the physicians did not understand the effects of medical treatments, depending on which statistic was used
(http://www.cmaj.ca/content/early/2015/10/26/cmaj.150430).

Essentially, we have the blind leading the blind when it comes to medical statistics and medical treatments. We need to put patients first and fix this. We need to focus on the net treatment benefit for the patient.

We need perspective. We need to know the “net treatment benefit for the patient” and we need to be able to see it. On the scale that is important to you, the patient, is the treatment near 0% or is it near 100% in terms of net benefit to you?


“The best interest of the patient is the only interest to be considered….” - William J. Mayo, M.D. – oldest Mayo brother, and one of the founders of the Mayo Clinic.

FINAL CALCULATION
Remember, the math behind the formula is:

Gross treatment benefit + positive side benefits – negative side effects = the net treatment benefit.

In the future, I want each step to be transparent to you. I want you to be able to verify every statistic and its source. That would be true shared decision-making.

FINAL TREATMENT SCORE
I am leaving the final Treatment Score blank for now. Vaccines are not like other medical treatments, for which it is much easier to figure out the net treatment benefit. Vaccines have side benefits of herd immunity preventing death, and herd immunity preventing disability, which are hard to put a number on. Your personal values regarding herd immunity are very important. In addition, there are more assumptions, uncertainties, and biases present in the studies I have reviewed to be comfortable summarizing the data down to one number (yet). It is much easier with other medical treatments, because it is easier to convert everything to be on the same scale, to have data from the same time period, and to be from the same geographic location. There is more objectivity with other medical treatments.

RULE OF VACCINES – 2
The benefits of a vaccine are a moving target.

When mumps, measles, and rubella are epidemic in a community killing people, and disabling people, it’s easier to see the benefits of the vaccine. As more and more people are vaccinated, the risks of death and disability go down. Eventually, as the vaccine causes death and disability to approach zero, the only damages left to see are the complications of the vaccine. Then, it becomes a tragedy that the disease wasn’t wiped off the face of the Earth, like smallpox was, because even a 1 in a million complication is too much. Vaccines have diminishing returns.

SHOULD YOU GET THE MMR II VACCINE?
Should you get the MMR II vaccine? I would not presume to tell you what to do. I’m not going to decide for you, because it's up to you. You have to look at the data yourself and use your values and preferences to decide together with your physician. That's how evidence-based medicine, medical ethics, and shared decision-making work. I’m not going to be paternalistic.

“The need for easily accessible and transparent information for patients is essential.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4337277/

WILL I GET THE MMR II VACCINE?
I already got the MMR II vaccine. It hurt my arm, but otherwise I was fine. I was essentially an average patient. Most importantly, I understood the science because it was well organized. Using my values, my assumptions, and the best data I could find, after adding it all together, it appears the net treatment benefit is around 3% in terms of increasing 5-year overall survival. 3% more kids alive is a great thing.

LIMITATIONS OF THIS ESSAY
This is deeply flawed essay, because the underlying data is from cohort studies, case control studies, and survey studies. These are low quality studies that can be subject to bias and confusion. This essay is a step in the right direction, and it will be rewritten and improved upon. This will not be the final version. In addition, I am biased to be pro-vaccine, because of the influence of “authority bias” and “eminence bias.” I tried to set my biases aside and be perfectly logical, using numbers only, but I felt my bias, because when I did calculations showing that vaccines were not as beneficial as I had imaged, I felt bad about it. It really is confusing that vaccine benefits are a moving target. Perhaps the bottom line is that we need to keep making vaccines safer and safer.

“The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate. The evidence of adverse events following immunisation with the MMR vaccine cannot be separated from its role in preventing the target diseases.” – V. Demicheli, et al. “Vaccines for measles, mumps and rubella in children.” Cochrane Database Syst Rev. 2012 Feb 15;(2):CD004407.
https://www.ncbi.nlm.nih.gov/pubmed/22336803

SOLUTIONS 
In the future, we will put patients first. As others have said, you are not a statistic; you are a human being. In the future, we will actually do evidence-based medicine and shared decision-making. Doctors and nurses will help patients organize the medical literature and summarize the most important treatment statistics for their disease.

“An important patient right is informed consent. This means that if you need a treatment, your health care provider must give you the information you need to make a decision.” – U.S. National Library of Medicine.
https://medlineplus.gov/patientrights.html

WE NEED A GROUP
It’s frustrating! The entire medical system should be geared toward figuring out the “net treatment benefit” for the patient, but sadly it is not. Let’s change this. What would really would be helpful would be a credible group of patients, doctors, and nurses, who put patients first, who are not working for Academia, Government, or Industry (or who declare their bias when they are), who produce Treatment Scores that are done transparently. That way we all would not have to spend countless hours trying to understand medical treatments, and we could begin to solve the 88% health illiteracy problem.

THANKS 
I (Olivia, the fictional toddler!) asked questions of several experts in order to write this essay. I am thanking them here, but this does not mean that they approve of this essay or its methods. I am not mentioning names, because vaccines are a controversial subject. All the errors, misinterpretations, and assumptions are mine. This essay is only a small step in right direction of providing better treatment transparency for all.

OLIVIA’S CO-AUTHORS
Bradley R. Hennenfent, M.D. (retired)
Stephen Fitzmeyer, M.D.

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DISCLAIMERS
Treatments Scores, Inc. and associated individuals do not claim to diagnose, cure, treat, or prevent any disease. Treatment Scores are an educational system to help you figure out the science of medicine behind treatments, which should be the starting point for shared decision-making. The information on this website should never be used as a substitute for the advice of a qualified, licensed physician or healthcare professional. We are not advocating any treatment, physician, medication, or any other entity. We are informational or educational only. We do not form doctor-patient relationships. Contact your physician for medical treatment. Call 911 if you may have an emergency or go to the Emergency Department. We are not responsible for any delays in care from information obtained from our site, nor for any consequential damages of any nature whatsoever, either directly or indirectly related to the use of this site, or from assumptions made. We cannot predict the future, we are only trying to do a better job of quantifying and reviewing what has happened in the past. We claim ZERO accuracy. We claim zero accuracy, because in medicine every patient is different, every statistic is a flawed statistic in some way, there are always estimations, and there is always bad or missing data. Averages may be used and no patient is average, every patient is unique. We make no promises or warranties whatsoever. ALWAYS SEE YOUR OWN PHYSICIAN FOR DIAGNOSIS AND TREATMENT.

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