Dr. David Brownstein fought Shingrix, and Shingrix won

Michigan, and Detroit in particular, are unfortunately like most large states and metropolitan areas in that here we have our share of “holistic” doctors and other practitioners peddling nonsense, including antivaccine pseudoscience. For instance, in the northern suburbs we have a naturopath named Doug Cutler peddling all manner of antivaccine quackery, along with the usual naturopathic quackery. (Of course, the two almost always go together.) Among the “real” doctors (i.e., actual, honest-to-goodness MDs or DOs), one prominent antivaxer is Dr. David Brownstein, a board-certified family physician practicing in the northern suburbs who’s big into “integrative medicine” (or, as I like to put it, the “integration” of mysticism, pseudoscience, and quackery into real medicine). Sadly, it seems that the northern suburbs seems to have an unusually high concentration of such “holistic” doctors, at least compared to the rest of the Detroit metropolitan area.

I’ve written about Dr. Brownstein a couple of times before, having first become aware of him when a friend and local internist named Dr. Peter Lipson took him to task for promoting antivaccine fear mongering among the large Jewish community in the area where he practices. Specifically, he was protesting the requirement for vaccines for Jewish children to attend Camp Tamarack, a Jewish summer camp. Both Dr. Lipson and I discussed how full of misinformation Dr. Brownstein’s screed was. Later that same year, I was amused by Dr. Brownstein’s unhappiness over the preponderance of questions on his family practice board recertification examination about medications and medication interactions. It was a tantrum full of sound and fury, signifying nothing, at least nothing with much, if any, science behind it. Now, I can understand the unhappiness with board recertification examinations, as I am facing my own surgery board recertification in early December. Such exams are massive time (and money) sinks that have never been shown to improve patient care. However, I complain about them for the right reason (that they are massive time and money sinks that have never been shown to improve patient care, particularly for subspecialists like me), not because they don’t include quackery and pseudoscience on them.

Dr. Brownstein, not surprisingly, is at it again. This time around, he’s very unhappy over the new recommendation that basically everyone over 50 receive the new shingles vaccine, Shingrix. Hilariously, he entitled is little screed I am trying NOT to write about vaccines… I can only retort that, for someone trying not to write about vaccines, Dr. Brownstein sure does write about vaccines a lot. For instance, a recent post on his blog complains about the “CDC whistleblower manufactroversy” and how, three years later, nothing has been done. Of course, the CDC whistleblower nonsense is an antivaccine conspiracy theory with basically nothing behind it touted by Andrew Wakefield and company, and I’ve written about it more times than I can remember. Then, another recent post by Dr. Brownstein is his annual rant against the influenza vaccine, full of the usual antivaccine tropes specific to the flu vaccine. Other recent posts by Dr. Brownstein include rants about how supposedly the AMA opposes vaccine research (hint: it doesn’t—it just opposes a “vaccine commission” headed by an antivaxer like Robert F. Kennedy, Jr.) and a post about the measles outbreak among Somali immigrants in Minnesota, in which he once again complains that nothing has been done about the CDC whistleblower. I could go on, but why bother, at least here? It’s the same old antivaccine pseudoscience regurgitated again and again.

The reason I took note of Dr. Brownstein’s latest bit is because he seems to think he’s found a slam-dunk line of argument against vaccines. As I go through his post, see if you can pick apart his argument before I get around to doing it later in this post. It’s an argument that he seems to think to be so clever that he’s used it in multiple recent posts. Before I get to that, though, I can’t help but note that laughed out loud at his introduction:

During our week in Colorado, we saw Suzy [Suzy Cohen—America’s Pharmacist] and her husband Sam many times. During one visit, we were talking about our respective blogs and I stated to her, “I am trying not to write about vaccines.” Suzy commented, “But you always write about vaccines, why are you trying not to write about them?”

I explained to Suzy and Sam that I am tired about writing about the problems with vaccines. I have been writing about the toxic ingredients of vaccines for well over a decade now. I do not want to be defined as an anti-vaxxer.

You see, I am not anti-vaccine. I am pro-health. If vaccines were safe and effective, I would be on-board with the CDC’s (Centers for Disease Control and Prevention) recommendations. However, we are presently giving too many ineffective vaccines which contain toxic ingredients and do not work as advertised.

“I am not antivaccine. I am pro-health.” Yep, Dr. Brownstein is antivaccine. Anyone who says something like that is 99.999% likely to be antivaccine, and Dr. Brownstein hasn’t provided me any evidence to suggest he’s part of that 0.0001% who say things like that and isn’t antivaccine.

Let’s just put it this way. If Dr. Brownstein is trying not to be perceived or defined as an antivaxer, he sure as hell is doing a piss-poor job of it. At least a third to a half of the posts on his blog are antivaccine rants. I’ve never seen him write or say anything good about vaccines, other than grudgingly admitting that the MMR vaccine does decrease the incidence of measles. Even then, he immediately followed that tortured admission with caveats, such as bemoaning how the vaccine doesn’t produce “natural immunity” and how it causes autism (even though it doesn’t). Let me put it this way: Does Dr. Brownstein routinely recommend any vaccine for any patient? I suspect you know the answer to that one. I certainly do. If he does think any vaccine is worth giving, I’ve yet to see a public statement from him saying so.

But let’s get to his “devastating” argument against the shingles vaccine. As you might have seen in the news, recently the CDC recommended a new vaccine against shingles, Shingrix, manufactured by GlaxoSmithKline, for all adults over 50 years of age without contraindications to the vaccine. For those unfamiliar with shingles, it’s a condition caused by the varicella zoster virus that can cause a painful rash and even nerve damage. Basically, if you’ve ever had chickenpox (and most of us over a certain age have—certainly I had it when I was seven years old or so), you’re at risk. Basically, after the chickenpox passes, the virus lays dormant in nerve cells, and can reactivate as shingles, where it can a painful rash that can include ugly skin ulcers along the distribution of major nerve roots. The illness can cause strokes, encephalitis, spinal cord damage, and, if it affects one of the facial nerves or optic nerves, loss of vision. One in three people with shingles can have lasting sequelae, such as chronic nerve pain that is difficult to treat. So, yes, shingles is a big deal. Personally, before my next visit to my doctor, I’m going to make sure he has the vaccine to give me, along with the hepatitis A vaccine given the outbreak going on in my area.

Dr. Brownstein, however, thinks the vaccine is worthless because…well, I’ll let him explain:

Let’s look at the Shingrix data. I went to the Physicians Desk Reference information on Shingrix. In section 14, the clinical trials used to get the vaccine approved are described. There were 14,759 subjects aged 50 years and older who received two doses of either Shingrix or placebo. In the NYT article, it was written that SHingrix was about 98% effective at preventing shingles for one year. The PDR report stated that same thing. If this vaccine was truly 98% effective, then I would have to seriously consider recommending Shingrix.

Here’s the actual data:

Six people out of 7,344 who received the two doses of Shingrix developed shingles—that is 0.08%. 210 out of 7,415 people who received the placebo became ill with shingles—that is 3%. How do they get 98% efficacy out of these numbers? Again, I have written about how the Big Pharma Cartel manipulates statistics to make a poorly performing drug or therapy look better than it actually is by using the relative risk (RR). Dividing .08% by 3% and subtracting from one provides the RR decline of nearly 98%. However, the relative risk is an inaccurate statistical model that should never be used to make clinical decisions. The more appropriate statistical model to determine if a drug or therapy should be used is the absolute risk reduction (ARR).

The ARR for this study can be calculated here: 3%-0.08%=2.9%. Therefore, a more appropriate determination of the effectiveness of Shingrix is that it is 2.9% effective at preventing shingles for a median of 3.1 years (the length of the study). And, a true statement about Shingrix is that it takes 34 people to be vaccinated with Shingrix (1/2.9%) to prevent one case of shingles. That means the drug failed 33 out of 34 who took it which is a 97% failure rate!

No, no, no, no. It is not a 97% “failure” rate. It’s not true that the vaccine “failed” in 97% of the cases. What happened is that for those 97%, the vaccine was irrelevant to whether they got shingles because they wouldn’t have gotten shingles anyway. Among the people destined to get shingles, though, it was highly effective. Of course, this sort of calculation is an issue for any intervention designed to prevent disease, like a vaccine. In any population, the vast majority of the population won’t get the disease that the intervention is intended to prevent, whether they get the intervention or not.

Let’s look at an example that I like to use to demonstrate that ARR is an important measure. I bring it up myself many times when referring to the efficacy of chemotherapy. A good rule of thumb is that, in appropriate patients, adjuvant chemotherapy for breast cancer reduces the relative risk of recurrence and death by roughly 30%. (I’m rounding for ease of computation; the number can vary a bit depending on the subtype of breast cancer and the chemotherapy regimen chosen.) In early stage breast cancers, that means that the actual ARR can be fairly small. For instance, let’s say a woman has a breast cancer with a ten year recurrence-free survival rate of 90% without chemotherapy, meaning she has a 10% chance of having a recurrence and dying if nothing is done. A 30% relative reduction in that risk due to chemotherapy would translate to an absolute risk reduction of around 3% (0.3 x 10% risk of recurrence and death = 3%). Her chances of survival would then be 93%. What that means is that, for 90% of women in this population who undergo adjuvant chemotherapy, the chemotherapy had no bearing on their disease. They wouldn’t have recurred anyway. For 7%, the chemotherapy “failed,” in that they recurred despite chemotherapy, while the chemotherapy prevented relapse and death in 3%. The problem, of course, is that we have no reliable way of predicting which women will recur and which won’t, which is why we treat them all. Basically, the chemotherapy saves 3 women out of a hundred (on average) from death. That means 33.3 women have to be treated to prevent one death, for a “number needed to treat” (NNT) of 33.3.

Of course, I also can’t help but point out that the benefits of adjuvant chemotherapy for breast cancer in terms of absolute risk reduction increase along with the risk of recurrence. If you have a patient with a 50% chance of recurrence and death in 10 years, then a 30% relative risk reduction would translate into an absolute risk reduction of 15%, resulting in a 65% chance of long term survival.

The reason I bring up the example of breast cancer is because of the similarity in the numbers to Dr. Brownstein’s example, at least for early stage breast cancer. Let’s just put it this way. Many women view an ARR of 3% of dying at the cost of undergoing toxic chemotherapy to be an acceptable tradeoff. Now let’s consider the Shingrix. Take a vaccine with minimal risk in order to cause a 3% decrease in the absolute risk of getting shingles. Look at it another way. Basically, this translates into a number needed to treat (NNT) to prevent one case of shingles of 33 or so. For a vaccine, that’s a pretty damned good NNT! For any preventive intervention in medicine intended for patients without symptoms, that’s a hell of a good NNT, particularly given how safe the vaccine is. But it’s even better than that. Out of the 3% who would get shingles in the time frame of the study (median 3.1 years of followup), the vaccine prevents 98% of cases. That is simply incredible efficacy.

Dr. Brownstein, as clever as he thinks he is being, is blatantly downplaying the benefits of the shingles vaccine using a misunderstanding of the statistics of preventive interventions. Notice that he focuses on just 3.1 years (the median duration of observation of the subjects in the study) and the general population. In other words, the ARR for shingles is 3% at one year, but what about subsequent years? Well, we can get an idea from the graphs showing vaccine efficacy from one of the actual studies (Study 1 and Study 2). In the second study, I note that the curves showing the incidence of shingles in the vaccinated and unvaccinated populations were still separating at four years after vaccination. In other words, the ARR was continuing to grow, because, as time goes on, more and more of the patients in the study were at risk for developing shingles. I’m betting that a subsequent publication of the data from this study, which is now five years old, will likely show that the ARR is much larger than what Brownstein cites.

You can look at the issue in terms of absolute numbers, as well, given that the law of large numbers means that even a relatively small ARR can translate into a lot of cases of disease prevented. Consider: There are over 100 million Americans over the age of 50 now, a number that is still growing. What’s 3% of 100 million? Three million. So if every older American were vaccinated with Shingrix, that would, by Brownstein’s own interpretation, prevent 3 million cases of shingles over roughly three years, a number that would definitely grow as time goes on.

Finally, let’s look at Dr. Brownstein’s hypocrisy for a moment. Using ARR to dismiss a treatment is disingenuous when it is not applied to other treatments. For instance, can Dr. Brownstein produce evidence for any of his favored treatments, which I’ve listed before, that indicates an NNT for disease prevention better than that of Shingrix? Let’s list some of them again:

• Acupuncture
• Massage Therapy
• Polarity Therapy
• Manipulative Medicine
• N.A.E.T.
• Micro-current Facials
• J.M.T.
• N.M.T.
• Emotional Freedom Technique (E.F.T.)
• Vitamin and Mineral Supplementation
• Intravenous Vitamin and Mineral Therapies
• Elimination and Allergy Diets
• Body Composition Analysis (B.I.A)
• Electro-Dermal Screening (E.D.S.) Full Bio-Profile Reports

Oh, and Dr. Brownstein is a graduate of the Desert Institute School of Clqssical Homeopathy. Homeopathy is, of course, The One Quackery To Rule Them All, being basically water mixed with sugar pills. Given that Dr. Brownstein he accepts an NNT of infinity as being acceptable, as long as it’s not one of those evil pharmaceuticals or vaccines being used, for which an NNT of 33 or so is utterly unacceptable.

Besides, if you don’t get the vaccine and get shingles, Dr. Brownstein has just the thing for you:

Yes, shingles is a horrible illness. I had it a year ago. A great treatment for shingles is ozone injections into the nerve root where shingles is occurring. It works nearly every time if it is done within a few days of the onset of the illness. Also, taking vitamin C (5-10,000mg/day) and L-lysine (1,000mg three times per day) helps.

Does Dr. Brownstein have any clinical trials to show that any of these interventions does any good whatsoever for a case of shingles? Of course not. He’s using interventions with an unknown ARR or efficacy that is almost certainly zero, meaning that he prefers to wait until disease develops and then use quack treatments with NNTs of infinity, instead of recommending a vaccine with an NNT of 33. Why? Because he is antivaccine. It’s the only explanation for such idiocy.