Weird Medicine Healthcare for the Rest of Us

May 4, 2017

Nutritional Supplements for Neuropathy

Filed under: Steve's Blog — dr steve @ 7:26 am

As many of you know, I suffered from a “demyelinating polyneuropathy” that gradually worsened last year. My symptoms were ataxia (inability to walk a straight line), loss of proprioception (inability to judge where parts of my body existed in space), and horrible paresthesias (pins and needles) in the extremities. My neurologist basically said “oh well, nothing we can do to fix this!” Frustrated, I did some research on my own and found some medications and nutritional supplements that actually have data behind them to support their use in neuropathies. Below is some of the information I found…maybe it’ll help someone you know.

For patients with cancer who are experiencing Chemotherapy Induced Peripheral Neuropathy (CIPN), duloxetine has the best evidence to recommend it (Grade 2B).

There is insufficient evidence to support a strong recommendation for any other treatment. However, in keeping with the recommendations from ASCO, a therapeutic trial of gabapentin/pregabalin or a tricyclic antidepressant (eg, nortriptyline or desipramine) is reasonable given the limited therapeutic options and the demonstrated efficacy of these drugs for other neuropathic pain conditions. Given the single borderline positive trial in patients with CIPN, it is also reasonable to try a compounded topical gel containing baclofen, amitriptyline HCl, and ketamine, understanding that this can only be manufactured by a compounding pharmacy and that ideally confirmatory results from other randomized trials regarding this treatment are needed.

In a situation where evidence based medicine has failed, it it sometimes appropriate to try, as a last resort, methods that have less strong evidence as long as the treatment plan meets the following criteria:
1) the treatment does not replace a possibly efficacious treatment that has good evidence
2) the treatment’s risk/benefit ratio is favorable
3) there is at least some positive evidence

Other dietary supplements that have some positive data (though none of them have class A evidence (double blind, placebo controlled reproducible trials) and are likely to do little or no harm include:

1) Acetyl L-Carnitine  (ALC)
Http://www.sciencedirect.com/science/article/pii/S0959804905004296
[Curr Pain Headache Rep. 2015 Dec;19(12):56.]
However in one study, ALC was found to worsen chemotherapy induced neuropathy at the 24 week mark
[J Clin Oncol. 2013 Jul 10;31(20):2627-33.]
but this remains controversial:
[J Pain Symptom Manage. 2013 Dec;46(6):887-96.]

2) Alpha Lipoic Acid (ALA)
http://onlinelibrary.wiley.com/doi/10.1111/j.1464-5491.2004.01109.x/full
[J Fam Pract. 2015 Aug;64(8):470-5.]

3) Myo-Inositol
http://www.sciencedirect.com/science/article/pii/002604957990060X

4) Gamma E Complex
Http://www.sciencedirect.com/science/article/pii/S0140673683925989
[Pharmacol Rep. 2014 Feb;66(1):44-8.]
[Int J Vitam Nutr Res. 2013;83(2):101-11]

5) Glutamine (specifically for Chemo Induced Peripheral Neuropathy)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3385273/

6) Vitamin K2-7
http://www.jpharmacol.com/article.asp?issn=0976-500X;year=2018;volume=9;issue=4;spage=180;epage=185;aulast=Mehta

On the “alternative medicine” front, there is some early evidence that Corydalis may be effective in neuropathic pain. Though this remedy has been used for hundreds of years, studies are only now being done and are still murine and murid-based only.
[PLoS One. 2016 Sep 13;11(9):e0162875.]

It should be noted that much of the evidence regarding dietary supplements and neuropathic pain is related to diabetic neuropathy (with the exception of glutamine, noted above), which may require different treatment than chemotherapy induced neuropathy.  Solid evidence continues to be lacking, and patients must be given information regarding the scientific method and how nutritional supplements or off-label drugs may or may not be effective.

Methadone can also be considered in patients with neuropathic pain that is refractory to the above. The advantages of using methadone for refractory pain in cancer patients or in those who could not tolerate the side effects of other opioids are well-cited in recent literature. Advantages of methadone over other opioids include but are not limited to: dual elimination without active metabolites allowing safe use with renal and liver failure, delta receptor activity in addition to mu receptor agonism, multiple routes of administration, rapid onset of action, long half-life, low cost and fewer adverse effects. In particular, methadone has salutary effects on hyperalgesia due to neuropathy, due to its antagonistic effect on NMDA receptors.

Disadvantages of methadone include the large variation in interindividual pharmacokinetics, potential for delayed toxicity,resistance of providers to write this medication, emerging state restrictions on its use, and its association with addiction therapy. Patients need to be screened for congential prolonged QT syndrome prior to initiation of therapy, and need to be followed periodically with EKGs to ensure the QTc is less than 450ms. Patients are counseled to avoid drugs and foods (e.g., ketoconazole or grapefruit juice) that can similarly prolong QT or inhibit CYP450. [Am J Hosp Palliat Care. 2011 Mar;28(2):135-40.]

Fortunately, in my case, my symptoms resolved nearly completely (I still have some hand numbness, but all of the other symptoms are gone) with the nutritional supplements alone. Obviously, my experience is anecdotal, but there’s enough decent evidence in the literature to support at least trying these supplements in refractory patients, because the chance of harm from them is so low. As always, DON’T DO ANYTHING WITHOUT A DISCUSSION WITH YOUR MEDICAL PROVIDER.

So there you go, email me if you have questions regarding the information above, and good luck!

yr obt svt,

Dr Steve

(PS: You can check out the supplements above by going to THIS LINK or click one of the images below.)


April 30, 2017

Study Of 95,727 Kids Re-Confirms That MMR Vaccine Not Linked To Autism

Filed under: Steve's Blog — dr steve @ 10:30 am

By Andrew M. Seaman

(Reuters Health) – The measles, mumps and rubella (MMR) vaccine is not linked to development of autism spectrum disorders, even among children considered to be at risk, a large new study finds.

Among nearly 100,000 children, receipt of the MMR vaccine did not increase the risk for autism spectrum disorder (ASD), regardless of whether kids were at higher risk because an older sibling already had the condition, researchers write in JAMA.

“Even for children who are high-risk, the vaccine does not play a role,” said lead author Dr. Anjali Jain of healthcare consulting firm The Lewin Group in Falls Church, Virginia. “We don’t know what does unfortunately, but it’s not the MMR vaccine.”

The results should be reassuring, she said.  Autism spectrum disorder is a range of symptoms that often includes difficulties with communication and social interaction, according to the U.S. National Institute of Mental Health. It’s may also include restricted and repetitive behaviors. The 1998 study that claimed to find a connection between the MMR vaccine and ASD was later debunked. The Lancet, the medical journal that originally published it, withdrew it. Studies continue to vouch for the safety of the vaccine. Still, some people continue to believe that the vaccine is connected to ASD. Parents of children with ASD may also believe there is a genetic component, and so they decline to vaccinate their other children, Jain and colleagues noted in their report in the Journal of the American Medical Association.

For the new study, the researchers used insurance claims data on 95,727 children followed from birth to at least age five between 2001 and 2012. They also had data on the children’s older siblings. Overall, about 2 percent of the children had an older sibling with ASD. Those children were more likely to go on to develop ASD themselves whether they were vaccinated or not, according to the report. The vaccine didn’t increase their risk, the researchers say.

For example, among high-risk five year olds, ASD developed in 23 of 269 who weren’t vaccinated (8.6 percent), compared to 30 of 796 (3.8 percent) who received two doses of the MMR vaccine.

Among kids not at high risk of ASD, 7,735 were unvaccinated at age five and 56 (0.7 percent) were diagnosed with the condition. That compared to 244 of 45,568 children (0.5 percent) who received two MMR doses. Furthermore, children with an older sibling with ASD were significantly less likely to have received the MMR vaccine in the first place. By age five, about 92 percent of the children without ASD in the family had received at least one MMR dose. By comparison, only 86 percent of children with an older sibling with ASD had been vaccinated by that age.  “I think it’s important to show that the degree of undervaccination in the families with children with autism spectrum disorder was significant,” Jain told Reuters Health.

Alongside the lack of association between the vaccine and ASD, the undervaccination rate deserves attention, she said. Roughly a dozen studies have shown that age of ASD onset and its severity do not differ between vaccinated and unvaccinated children, wrote Dr. Bryan King, program director of the Autism Center at Seattle Children’s Hospital, in an editorial accompanying the new study. The new study, King added, now shows that “the risk of ASD recurrence in families does not differ between vaccinated and unvaccinated children.”

SOURCE: http://bit.ly/1JqtTOK JAMA, online April 21, 2015.

April 14, 2017

Which One of You Created EstebanTheMagnificent.com?

Filed under: Steve's Blog — dr steve @ 8:56 am

Ha ha some genius who lingers WAY longer heard me tell the story of my magic show in the 7th grade, billed as “Esteban the Magnificent,” and what I really did with the silk foulard that was part of my zombie ball trick.

 

Anyway, an artist who actually illustrated a book with a character “ESTEBAN THE MAGNIFICENT” (coinkydink?) reached out to me to see if she could get the domain name.  Since whoever did this signed up private on WHOIS, I can’t reach you any other way.

Perhaps the artist will pay for the domain, perhaps other special treats are in store for you, or maybe just a hearty handshake.  But if you work something out with her, I’ll send you some exclusive merch that no one else will have.

 

Email me through the contact tab on this site!

 

your pal,

 

 

Steve

March 22, 2017

THE TRUTH ABOUT “LOW NORMAL TESTOSTERONE”

Filed under: Steve's Blog — dr steve @ 1:47 pm

I’ve been asked so many times about this, that I am past-due for posting on this subject. This is one of the articles I reference, when discussing the treatment of “low normal” testosterone:

Aging Male. 2012 Dec;15(4):198-207. doi: 10.3109/13685538.2012.699562. Epub 2012 Jul 26.

A randomized, double-blind, placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up.

Behre HM1, et al

Center for Reproductive Medicine and Andrology of the University, Halle, Germany. hermann.behre@medizin.uni-halle.de

Abstract

INTRODUCTION:

The clinical significance of low to low-normal testosterone (T) levels in men remains debated.

AIM:

To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL).

METHODS:

Randomized, double-blind, placebo-controlled study. Men, aged 50-80 years, with serum total T<15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males’ Symptoms (AMS) total score >36, received 6 months treatment with transdermal 1% T gel (5-7.5?mg/day; n =183) or placebo gel (n =179), followed by 12 months open-label with T in all.

RESULTS:

After 6 months, LBM increased in T- treated patients by 1.28?±?0.15?kg (mean ± SE) and FM decreased by 1.16?±?0.16?kg, with minor changes with placebo (LBM +0.02?±?0.10?kg and FM -0.14?±?0.12?kg; all p < 0.001, T group vs. placebo). Changes were largely similar across subgroups of age, baseline total testosterone, and baseline BMI. Total HRQoL improved compared with placebo (p < 0.05, T group vs. placebo).

CONCLUSIONS:

Six months 1% T gel improved body composition and HRQoL in symptomatic men with low to low-normal T, with further improvements over the following 12 months.

 

In other words, in SYMPTOMATIC men (those with symptoms consistent with androgen deficiency, i.e., fatigue, erectile dysfunction, loss of libido, weakness) with “LOW NORMAL” testosterone (i.e., in the low range of “normal” (more on this later)), there is improved QUALITY OF LIFE when these patients are TREATED.

So you may ask, “if they’re in the ‘normal’ range, how can they be also ‘abnormal’?”   The answer is in the way “normal” levels are determined.  Basically take 1000 men and draw testosterone levels on them.  Exclude men with diagnosed hypogonadism (low testosterone), of course.  Then average the results and do a mathematical process to determine 2 “standard deviations from the mean.”   This sets your low and high normal levels.  The real process is a bit more complicated, but that’s the gist of it.

Well, what happens when your pool of “normal” candidates, from whom the normal range is derived, contains a SHIT LOAD of people with undiagnosed hypogonadism?  It is estimated that the vast majority of men with low T go undiagnosed (it may be as high as 95%!).   It follows that these undiagnosed men with hypogonadism will drag the average down, thus creating a normal range that also includes people who have symptomatic disease.

So, if you have symptoms of low T, and they’ve ruled out anemia, sleep apnea, depression and low thyroid, a savvy provider who understands the above may opt to treat (at least for awhile to see if it helps) you even if you’re in the “low normal” range.

Remember, testosterone replacement is real medicine, by prescription only, and should be done under the supervision of a licensed medical provider only.  There are downsides to this as well, and make sure your prescriber discusses the risks, benefits, and alternatives to treatment before embarking on any new regimen.

yr obt svt,

 

Dr Steve

 

 

PS: I’ve fallen to #12 on MoogFest.com!  Until March 23, if you’re reading this, please click on this link:

http://moogfest.com/giveaway?referral=HyuCMEDqe&refSource=copy

click SHARE NOW, enter your first name and email and you’ll get a cool Moog Synthesizer newsletter, and you’ll help Lady Diagnosis and me win a piece of equipment for the studio.  I’m pretty sure there are shenanigans going on with some of the entrants, but I would like to win fair and square.

 

THANKS!

 

 

February 4, 2017

Dietary Supplements and Risk of Cause-Specific Death, Cardiovascular Disease, and Cancer

Filed under: Steve's Blog — Tags: , , , , — dr steve @ 2:19 pm

Here’s a nice article doing some actual SCIENCE on dietary supplements and health.  People ask me all the time, “do dietary supplements work?”  My first question is always “what do you want to accomplish?”  If you say,  “I want to take Vitamin D to prevent rickets,”  I’m all in!  If you say “I want to take Vitamin C to prevent the common cold,” I can’t find any decent data to support it.

So we have to define our endpoints (what do we want to accomplish) then study how various supplements help us reach those endpoints.  Sometimes, as in the case of “antioxidants,” the data may surprise and dismay us.  Other times, we may see a positive result and be able to make general statements about certain supplements.  Read this abstract and I’ll see you at the end for a brief analysis!  [Emphasis added below]

Dietary Supplements and Risk of Cause-Specific Death, Cardiovascular Disease, and Cancer: A Systematic Review and Meta-Analysis of Primary Prevention Trials1,2,3

Abstract

Our aim was to assess the efficacy of dietary supplements in the primary prevention of cause-specific death, cardiovascular disease (CVD), and cancer by using meta-analytical approaches. Electronic and hand searches were performed until August 2016. Inclusion criteria were as follows: 1) minimum intervention period of 12 mo; 2) primary prevention trials; 3) mean age >18 y; 4) interventions included vitamins, fatty acids, minerals, supplements containing combinations of vitamins and minerals, protein, fiber, prebiotics, and probiotics; and 5) primary outcome of all-cause mortality and secondary outcomes of mortality or incidence from CVD or cancer. Pooled effects across studies were estimated by using random-effects meta-analysis. Overall, 49 trials (69 reports) including 287,304 participants met the inclusion criteria. Thirty-two trials were judged as low risk–, 15 trials as moderate risk–, and 2 trials as high risk–of-bias studies.

Supplements containing vitamin E (RR: 0.88; 95% CI: 0.80, 0.96) significantly reduced cardiovascular mortality risk, whereas supplements with folic acid reduced the risk of CVD (RR: 0.81; 95% CI: 0.70, 0.94). Vitamins D, C, and K; selenium; zinc; magnesium; and eicosapentaenoic acid showed no significant risk reduction for any of the outcomes. On the contrary, vitamin A was linked to an increased cancer risk (RR: 1.16; 95% CI: 1.00, 1.35). Supplements with beta-carotene showed no significant effect; however, in the subgroup with betacarotene given singly, an increased risk of all-cause mortality by 6% (RR: 1.06; 95% CI: 1.02, 1.10) was observed. Taken together, we found insufficient evidence to support the use of dietary supplements in the primary prevention of cause-specific death, incidence of CVD, and incidence of cancer. The application of some supplements generated small beneficial effects; however, the heterogeneous types and doses of supplements limit the generalizability to the overall population.

So, given this meta-analysis, if you want to try to reduce your risk of cardiovascular disease, Now Foods Advanced Gamma E Complex, Soft-gels, 120-Count  and Nature Made Folic Acid 400mcg, 250 Tablets (Pack of 3) may be worth a shot. Otherwise, at least for the supplements and outcomes they measured, no other supplements provided a positive effect, and some made things worse (beta carotene and vitamin A, basically).

We’ll stay on this; we’re always looking for new evidence to make your (our) lives better!

 

yr obt svt,

 

Steve

October 3, 2016

Weird Medicine Premium Content

Filed under: Steve's Blog — dr steve @ 4:17 pm

If you visit this site frequently, you’ll notice some changes since October 3, 2016.   If you simply listen to each new show as it comes out, none of this will affect you!  The most recent 5 shows will always be available for free.  Behind the “PayWall” will be the complete archives of Weird Medicine, going back to 2007,  and extra content (mini-shows, interviews, music, whatever I can think of).  If you’re new to the show and want to go back and listen to all the old shows as many do, you can do this behind the paywall, too.

The cost: $1.99/month.  You can cancel any time, and PLEASE let me know if you have any problems with billing or technical issues and I’ll get them fixed immediately.

You can also download the iOS (Apple) app HERE, or the ANDROID app HERE and listen on your multitude of devices without having to screw around with logging in to some crappy website to hear our show.

Why are we doing this?  The reality is that this will help me keep the show going, and help keep RiotCast viable as a network.  We appreciate your support and do not demand anything from our listeners, but if they want to support us in this way (and get access to crap no one else has) we appreciate it!   There are other reasons, too, but you can probably guess what benefit there might be in not having 200+ episodes of me saying wacky things just sitting out there for anyone to hear.  🙂

As always, thank you all so much for your continued support;  we love our listeners and always appreciate your topic ideas, suggestions, and financial aid.  🙂

 

yr obt svt,

 

Dr Steve

August 7, 2016

The Truth about Gardasil

Filed under: Steve's Blog — dr steve @ 12:00 am

–Dr Steve

The Gardasil HPV vaccine hasn’t been proved to have caused the deaths of 32 women.

NIAID/Flickr

CLAIM: The Gardasil HPV vaccine has been proved to have caused the deaths of 32 women.

FALSE

EXAMPLE: [Collected via e-mail, April 2009]

32 Girls Have Died

11,916 adverse events already reported to the CDC … and counting.

Pain and swelling. Life-threatening muscle weakness. Blood clots in the heart and lungs.

And the deaths of 32 innocent girls and young women.

You might think I’m talking about a deadly new disease or a global epidemic …

I’m not.

Sadly, it’s more sinister than that. The health threats listed above have all been linked with Gardasil, the so-called “cervical cancer vaccine.” And thanks to Pharma giant Merck, desperate parents and naive young women believe this vaccine saves lives… they couldn’t be more wrong.

That’s why HSI’s Jenny Thompson has released a new video in which she exposes the deception for what it is — and reveals some truly shocking information no one else is talking about.

And you are the very first to see it.

Please, if you have daughters, granddaughters or friends who might be considering this terrible vaccine, you must watch this video. And please forward it to anyone you think would benefit from the vital information it contains.

If you think you know the whole story on Gardasil, I think you’ll be shocked by what you’re about to see. Just click here to start watching the video. It’s just a few minutes long…and those few minutes might just save a young girl’s life.

ORIGIN:Gardasil is a vaccine intended for girls and young women between the ages 9 to 26 to protect against human papillomavirus (HPV), a virus which is currently linked to an estimated 70% of known cervical cancer cases. Because Gardasil prevents only the onset of HPV infections (rather than curing those who have already been infected by HPV), health officials have advocated that girls be vaccinated for HPV prior to adolescence (or as soon as possible thereafter) in order to head off the occurrence of cervical cancer later in life.

The message quoted above warns that the Centers for Disease Control (CDC) has already received nearly 12,000 complaints about adverse medical issues related to Gardasil vaccinations, and that 32 young women died after receiving Gardasil vaccinations. Although this information is accurate in a strictly literal sense, it is a misleading presentation of raw data that does not in itself establish a causal connection between Gardasil and the posited medical dangers.

The CDC, in conjunction with the Food and Drug Administration (FDA), operates a program known as the Vaccine Adverse Event Reporting System (VAERS). The VAERS program collects and analyzes reports on adverse events following immunizations in order to help track the safety and efficacy of various vaccines. It is important to note that reports collected by VAERS are raw data; they do not in themselves establish causal connections between vaccines and adverse medical issues — such determinations cannot be made until the reports have been investigated, evaluated, and analyzed.

(To illustrate this concept, we offer the following [admittedly far-fetched] scenario: A man who received a flu vaccination and then accidentally hit his hand with a hammer a few hours later might legitimately report that soon after he received the flu vaccine, his hand began to throb painfully. Although such a report would be literally true, it would not establish any causal connection between the flu vaccine and the adverse medical symptom of a throbbing, painful hand.)

As the CDC stated in its 2009 article on “Reports of Health Concerns Following HPV Vaccination,” before the Gardasil HPV vaccine was licensed it was studied in five clinical trials involving over 21,000 girls and women of ages 9 through 26. Since that licensing the “CDC and FDA have been closely monitoring the safety of the HPV vaccine” and found that:

All serious reports for Gardasil have been carefully analyzed by medical experts. Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine.

As of December 31, 2008, there have been 32 U.S. reports of death among females who have received the vaccine. There was no common pattern to the deaths that would suggest that they were caused by the vaccine.

From June 2006 to March 2013, approximately 57 million doses of HPV vaccines were distributed and VAERS received approximately 22,000 adverse event reports occurring in girls and women who received them. As noted in a 2013 CDC follow-up announcement, 92% of those reports were classified as “non-serious,” the other 8% generally encompassed symptoms such as “headache, nausea, vomiting, fatigue, dizziness, syncope, and generalized weakness,” and adverse events reported to VAERS were “consistent with those identified during the vaccine’s pre-licensure clinical trials.” The CDC also noted that:

In 2011, the VSD (Vaccine Safety Datalink) studied the occurrence of specific adverse events following more than 600,000 doses of Gardasil. Adverse events in the HPV vaccinated population were compared to another appropriate population (such as adolescents vaccinated with vaccines other than HPV) and included Guillain-Barré syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope (fainting), allergic reactions, and a potentially life-threatening allergic reaction called anaphylaxis. None of these adverse events were found to be any more common after HPV vaccination than among the comparison groups.

As Matthew Herper wrote for Forbes about the reported “deaths caused by Gardasil” phenomenon:

[L]et’s take a look at those 20,000 adverse events and 100 deaths and figure out what they mean. It’s absolutely clear that these are for the most part not side effects from Gardasil. Nor is the vaccine, which has been given to more than 10 million people, likely responsible for those deaths.

The Vaccine Adverse Event Reporting System was put in place in 1990 as a result of a 1986 law that requires health providers to report harm that comes to patients within a specific time period after vaccination. A great many of these reports can come from sales reps for drug manufacturers who hear about the incidents.

Unfortunately, VAERS data is notoriously spotty — better than nothing, but there’s no way to insure that potential side effects are reported. When a product gets bad press, the number of reported “adverse events” goes up. And there is no way to tell if a particular side effect is linked to the vaccine. Some people will die after any vaccination, not because vaccines cause death but because people, even babies and adolescents, die with terrible regularity.

It’s true that there have been 24,000 reports of adverse events with Gardasil. There have also been 60,000 reports of death with the mumps, measles, and rubella vaccine, and 26,000 following vaccination with Pfizer’s Prevnar, for pneumococcus bacteria. And yes, it’s true that there have been 106 deaths reported after Gardasil vaccination. There have also been 101 deaths reported after vaccination with Prevnar 13, a new version of Prevnar introduced in 2010. It’s normal for these reports to pour in for safe vaccines.

You can’t directly link any of those adverse events or deaths directly to the vaccines, any more than you could blame it on my morning coffee if I got hit by a truck later today. So to try to make use of this data, researchers compare the rates at which negative side effects are reported for different vaccines. The CDC and FDA did this for HPV vaccines in 2009, looking at the first 12,424 reports to VAERS and publishing the result in the Journal of the American Medical Association. They did note 2 cases of unusual neurological symptoms similar to Lou Gehrig’s disease, and there was an increase in patients who had potentially dangerous blood clots, although 90% of those patients had a risk factor for those clots, such as taking birth control pills, that might explain the increase. The researchers specifically looked at Guillain-Barré Syndrome, a neurological disorder that had been linked to a bad batch of flu shots; there wasn’t a signal that this was a problem with Gardasil. The study did result in the FDA advising doctors to watch adolescents after they get their shots, because some faint.

Based on that analysis, it seems that of those dozens of deaths, only a handful could possibly be linked to Gardasil. And based on the data available, it is unlikely (though not impossible) that even those deaths were caused by the vaccine. The risks from the vaccine are very small and may be limited to headaches and fainting caused by the needle, not the vaccine itself. Gardasil has been studied in clinical trials of more than 30,000 people; Cervarix, the competitor vaccine, has run a similar gantlet.

A couple of other pieces of anti-Gardasil misinformation have been widely circulated, such as the video featuring Jenny Thompson of Health Sciences Institute which is linked at the end of the warning reproduced at the head of this page:

Note that this video deals primarily with subjects such as the political and moral issues involved with requiring HPV vaccinations for young girls, the notion that vaccinated girls might mistakenly believe they had been immunized against contracting sexually transmitted diseases (other than HPV), and the claim that cervical cancer deaths can be effectively eliminated through means other than HPV vaccinations. It offers no real evidence that Gardasil vaccinations are dangerous other than to cite the raw VAERS data referenced above (without noting that analysis of those reports failed to establish a causal link between HPV vaccinations and the reported serious adverse events).Likewise, another much-reproduced article claims that in 2009, Dr. Diane Harper (who is consistently misidentified as “the lead researcher in the development of Gardasil and Cervarix”) gave a talk at which she “came clean” and admitted that “Gardasil and Cervarix don’t work, are dangerous, and weren’t tested.” That article grossly misrepresents what Dr. Harper actually said. Dr. Harper has expressed concerns such as how long protection from vaccines such as Gardasil will last (which is not a safety issue, but rather an issue of whether the expected results of an HPV immunization program will justify the financial costs), and whether the marketing of Gardasil might lead some women to avoid taking other STD-preventing precautions, but she has never said that Gardasil “doesn’t work,” “wasn’t tested,” or was “dangerous,” as explained in great detail at the Skeptical Raptor blog:

In a 2012 peer-reviewed article about Cervarix, Dr. Harper states that “Cervarix is an excellent choice for both screened and unscreened populations due to its long-lasting protection, its broad protection for at least five oncogenic HPV types, the potential to use only one-dose for the same level of protection, and its safety.” Again, she speculates that cervical cancer screening may be just as useful, but nowhere does she recommend that the vaccine not be used, that it’s safety profile is unacceptable, or that the vaccine cannot prevent cancer. In fact, she recommends expanding the guidelines for HPV vaccines for older women because as they age, they are more susceptible to other serotypes of HPV, against which Cervarix confers protection. She also states that Cervarix may also have a protective effect against some autoimmune disorders. This does not sound like a researcher who is losing sleep about the HPV vaccine, but who fully supports its use, with some exceptions.

Dr. Diane Harper is one of the leading researchers in biomedical science, an individual who has spent her life studying vaccines. She has the academic training and research credibility at a level that if she said “Gardasil is dangerous,” many of us would stand up and begin to wonder. But the facts are she has not said anything of the sort about Gardasil and Cervarix. In peer-reviewed articles published in important, high impact journals, she has given strong, but scientifically qualified, endorsements to HPV vaccines. These are the facts. Any other allegations about her lack of support for vaccinations is based on misinformation, disinformation and lies.

A 2009 CBS News interview with Dr. Harper is often cited as contradicting this assessment, but it does not: Dr. Harper did not state during that interview that Gardasil doesn’t work, is dangerous, or wasn’t tested. Given questions about how long the vaccine is effective for, she questioned the efficacy of giving shots to girls as young as 11 years old in parts of the world (such as the U.S.) where women regularly undergo safety Pap screening repeatedly over their lifetimes, saying that the chances of their contracting cervical cancer may be less than the “small” risks associated with the vaccine. But Dr. Harper also noted that the risks of death surrounding the administration of Gardasil were “very rare,” and that she “agrees with Merck and the CDC that Gardasil is safe for most girls and women.”

May 12, 2016

Thank You For Being a Part of Our Lives, Pal

Filed under: Steve's Blog — dr steve @ 7:37 pm

Today was a day from hell;  we lost our dear friend Greg Petraitis, known to radio listeners as GVac.  I want everyone to know he died suddenly and did not suffer.  His family is in shock, so please be gentle and give them some time to process this tragic information.

Greg was selfless and loveable, he gladly gave of himself and was never without his sense of humor and infectious laugh.   What an amazing musician, too…he was driving 90 minutes each way to work out a set with Dr Scott and me for an Alzheimer’s benefit;  there was no real benefit to him other than performing and being with his friends.  One of the sweetest (he’d hate that word), nicest people on the planet, and now he’s gone.

Thank you and goodbye, GVac, you were universally loved and our lives will never be the same without you.

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More soon, we’re too devastated to write anything more.  I see these pictures and I immediately become intensely sad again.  His mic will be retired and his person will never be forgotten.

 

yr obt svt,

 

 

Steve

January 28, 2016

Don’t Fear the PPI (but Don’t Take it if You Don’t Need It)

Filed under: Steve's Blog — dr steve @ 10:39 am

Much has been touted in the media and social media about the recent proton pump inhibitor (PPI) study in JAMA relating long term use of these drugs to chronic kidney disease.  There is so much hype that I thought it important to take a closer look.

The study in JAMA is only available to the public as an abstract, which means the authors condensed an 8 page document into 7 paragraphs (basically a half-page).  This is standard…you  have to PAY to be able to read the whole article, and the abstract doesn’t tell the whole story.   Your old pal, an individual who cares about his listeners, arranged to get a full-text copy of the article so we can go over the “numbahs” together.

First, this is a “cohort study” and it’s “retrospective” and therefore “observational.”  This means they took a ton of people who were in another study (Atherosclerosis Risk in Communities (ARiC)) and teased out information they weren’t originally looking for out of the data after the fact.   Basically you take 10,000 or more people and find the ones on long term PPIs and see how many developed kidney disease (and how you define that matters) and compare them against all the people in the group who DIDN’T take PPIs and see if there’s a difference.   This is a decent study, as far as cohort studies go, but when we look at levels of evidence, we see that this kind of study isn’t the best for proving a scientific point:

quality of evidence

There are two levels of evidence above cohort study that are generally considered to result in better quality, and therefore more believable, results.  Performing a double blind, placebo controlled study comparing kidney disease rates in PPI vs Non-PPI users would take another 10 or more years to complete, so this is the best data we have right now (and it’s decent, as I said.)  So let’s go with it.

There were 10482 participants in the ARiC study.   Since this study was not designed to look at PPI use initially (the data was gathered as part of a general information gathering system regarding the patients enrolled), there were some lopsided aspects to the PPI group.  For example, the PPI users were more often obese, white, and hypertensive than the non-PPI users.  This is the kind of thing that can cause bias to creep into a study (hypertensive patients are more likely to develop kidney disease, for example) that would be eliminated from a randomized, control trial.

Of the 10482 participants, there were 1438 cases of chronic kidney disease identified (13.7%).  There were 56 events in the PPI group (of which there were 322 users), amounting to 17.4% (0.174).   In the non-PPI group, 1382 out of 10160 patients developed kidney disease, or 13.6% (0.136).   You can spread this out into patient-years and all kinds of things, but we can see that there is a higher percentage of kidney disease in the PPI group than the non-PPI group, and the difference is 17.4/13.6 or a 27.9% increase.  (They used another cohort to confirm these results and make the data more powerful.)

This is where the headlines come from: “A 30 PERCENT INCREASE IN KIDNEY DISEASE IN PPI USERS!”

So that certainly seems to be “true,” in the sense that to the best of our knowledge, there is an increased risk of chronic kidney disease in people who take PPIs for years and years, but what does that mean for the individual?  And does this make PPIs “bad drugs?”

To figure this out, we need to review the difference between absolute risk and relative risk.

If you have 1000 people in a treatment group and 1000 people in a placebo group, and 10 people have an adverse reaction in the treatment group and only 7 have one in the placebo group, you could say that there is a 30% increase in that adverse reaction in the treatment group.  But the ABSOLUTE increase was only 3 patients out of a thousand so the absolute risk to the individual would be 3/1000 or 0.003 or 0.3%.   In addition, we can take the inverse of this number to figure out the “Number Needed to Harm(NNH)” (i.e., how many people have to take the drug to have one excess incident of the adverse effect), which in this case would be 333.  So the risk to the individual is quite low;  your odds would be 332 to 1 of NOT getting the adverse event.  Another way to look at it is that 99.7% of the time you’d be ok.

Let’s apply this to the case at hand:  The absolute risk of developing chronic kidney disease from taking chronic PPI is 0.174-0.136=0.038.  Therefore the Number Needed to Harm is 1/.038, or 26.  So the risk to you, the individual, taking a PPI for years and years and years, and developing chronic kidney disease associated with PPI use is 25 to 1, or 3.8%.  In other words, you wouldn’t get PPI-associated CKD (assuming this effect is real) 96.2% of the time.  We can look at it another way:  the risk to the individual is very low, but the risk to society (factor that Number Needed to Harm into the MILLIONS of people taking PPIs every year) is greater.   Additionally, this data is from 1996 to 2011, and newer PPIs that were not included may not even have this same effect.

There are other adverse effects from decreasing acid production in the stomach…there may be an increase in bacterial illnesses due to the decrease in bacteria-killing hydrochloric acid in the stomach.  There have been suggestions of increased bone fractures in elderly patients who take PPIs chronically, but the NNH is greater than 1200 on that one and may be erroneous.

The flip side of this is that PPIs are very, very effective at what they do.  The Number Needed to Treat for total healing of erosive esophagitis is 6.  The Number Needed to Treat to reduce GI rebleeding (preventing recurrence after a first GI bleed) is 13.  We used to see dozens of vagotomy/antrectomy procedures a year in a decent sized hospital before the advent of H2 blockers (e.g., ranitidine) and PPIs…I believe we saw ONE in our institution last year and that was for someone with a genetic predisposition to overproduction of acid.   So PPIs have reduced surgery rates and concomitant surgical complications.  In addition, quality of life is improved in patients on PPIs, but only under certain circumstances.  PPIs are still “Generally Considered Safe.

There are adverse effects with every medication (google the number of deaths from acetaminophen last year for an eye opener).  Proper medical treatment involves balancing risk vs benefit.  Proper medical treatment also dictates that people be treated for the proper indication.  It is estimated that 20-70% of people who take PPIs take them without a proper indication.  In addition, being OTC, these medications can be taken for years without a healthcare provider’s supervision.

Lifestyle measures may help a significant fraction of heartburn sufferers treat their symptoms without medication.  For refractory cases, primary care and gastroenterologists have a full array of treatments, surgical, medical, and lifestyle to relieve symptoms and reduce adverse outcomes.  One of the most powerful weapons is still the proton pump inhibitor, so if you’re prescribed one for a proper indication, don’t fear it, just be aware of the risks and benefits and take it only as long as necessary and at the lowest effective dose.   Remember, the risk to YOU, the individual is low (but never zero).

 

yr obt svt,

 

Dr Steve

 

December 9, 2015

Intern Jesse’s Internship Debriefing

Filed under: Steve's Blog — dr steve @ 8:16 am

This is the paper Intern Jesse (now Associate Producer Jesse) had to turn in to his university to get credit for his rotation with us.  He did a great job, and deserved the solid C+ we gave him for his efforts.  🙂

 

Internship Reflection

“It’s Weird Medicine, the first, and still only, uncensored medical show in the history of radio!”  In the last few months, I’ve heard those words more times than I can count.  That one phrase, along with a hefty majority of the rest of the introduction, is burned into my memory.  I can recite SiriusXM channels, website URLs, promotional codes, and phone numbers without even thinking about it.  I’m not complaining, though.  Not by a long shot.

This semester I had the great fortune to intern with Weird Medicine, an established SiriusXM show and podcast on the Riotcast Network, as an assistant producer.  Each week, I met up with Dr. Steve and the rest of the Weird Medicine crew and we recorded the SiriusXM show for that week.  Once a month, we’d all get together at the studio and record enough podcasts to get us through till the next month.  It could be a lot of work sometimes, but I wouldn’t have traded it for anything.

I’m not really sure what I can say that would adequately describe my working with Dr. Steve and the Weird Medicine crew that would also fill up three pages.  Each time I walked into the studio was extremely different than the last.  I had no idea what questions were going to show up that day, whether they be about some devastating illness, the many, many problems that I learned that people can have with their assorted genitalia, or even people calling in just to say hello or to throw in some obscure reference to an Opie and Anthony episode from however many years back that would leave everyone in stitches.  I’ve gotten a lot more practice mixing audio and learning the importance of compressors for broadcast audio.  I’ve screened calls, looked up the Material Safety Data Sheet (MSDS) for obscure chemicals, monitored UStream chatrooms during our live tapings, and made multiple “Best Of” shows for both the podcast and the SiriusXM show.  All in all, the entire experience was a lot of fun and I learned so much from it.

One of the things that I learned during my time with Weird Medicine is the importance of the various social media platforms that we have at our disposal.  Dr. Steve has so many people tweeting at him every day that I was honestly surprised that checking the Twitter wasn’t one of my duties.  Still, he manages to reply to almost every single tweet that gets sent to him every day.  The same goes for any questions posted to the Weird Medicine sub-Reddit and any emails or text messages that his listeners send to him.  He’s made it a point to build a community around these shows, and these people are all united in a way.  People are sharing links to different scientific studies, they’re answering each other’s’ questions or helping point them in the right direction.  They have regular listeners that call in frequently and regular listeners that might not call in, but they’re always there in the UStream chatroom for the live recordings.  No one is judging them for asking for help from some random doctor on the radio, and everyone acts like they’re friends with everyone.  Don’t get me wrong, there are also jokes at each other’s expense, but that’s what friends do.  Right?

As someone who looks at podcasting as a possible career choice, seeing the way that Dr. Steve has built this community around these shows shows me just how important social media is.  In fact, I’ve become quite a bit more active on Twitter since I started the internship and have interacted with the Weird Medicine community quite a bit myself.  I even used a lot of their input when I was building the first “Best Of” show that I made for Dr. Steve.  Believe me, there were a lot of people that were more than willing to tell me the funniest thing they’d ever heard on the show just so I could make sure other people got to listen to it, too.

As I said before, the whole experience was great fun and I learned a lot from it.  Not only that, but I’ve also made some connections with some great people.  Aside from the Weird Medicine crew, I’ve also interacted with another couple of podcasters and even gotten a shout out on one podcast for the work that I put in on my “Best Of” shows.  All in all, I’m so glad that I had this opportunity come my way, and I look forward to helping Weird Medicine and Doctor Steve by producing some more things for the show in the future.

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