There was an article published in Pediatrics that described how educating either teenagers or their parents about HPV vaccinations had little effect on the overall vaccination rate for the vaccine. Essentially, the researchers found that it was a 50:50 probability that any teen would get the vaccine, regardless of their knowledge of HPV and the vaccine itself. Some of the reasons why the HPV vaccine uptake is so low is a result of several myths about Gardasil safety and efficacy.
So I thought about why that Pediatrics study found that education about HPV and Gardasil didn’t move the needle on vaccination uptake. It’s possible that the benefits of the vaccine is overwhelmed by two factors–first, that there’s a disconnect between personal activities today vs. a disease that may or may not show up 20-30 years from now; and second, that the invented concerns about the HPV quadrivalent vaccine, promulgated by the usual suspects in the antivaccination world, makes people think that there is a clear risk from the vaccine which is not balanced by preventing cancer decades from now. It’s frustrating. Continue reading “Gardasil safety and efficacy – debunking the HPV vaccine myths”
Here we go again. We recently wrote about Diane Harper, another “lead developer” of the HPV vaccines, who has a rather complicated view on HPV vaccines. She makes disparaging remarks about the vaccine, yet her peer reviewed publications are generally favorable to the HPV vaccine. Genevieve Rail, a kinesiology researcher at Concordia University in Montreal, Quebec, Canada is the next one being pushed by anti-vaccine activists.
Outrageous claims are made about Genevieve Rail’s expertise with HPV vaccines, like Gardasil. And she helps with the claims by making outlandish comments about the vaccine:
“I’m sort of raising a red flag, out of respect for what I’ve found in my own study, and for the despair of parents who had totally perfect 12-year-olds who are now in their beds, too tired to go to school. Yes, we’re going against the grain, and we are going against those who are believed, i.e. doctors and nurses and people in public health.”
A few years ago, Dr. Diane Harper was the darling of the anti-vaccine world, for two reasons. First, she was one of the researchers who performed clinical trials for Gardasil. And second, she appeared to be against HPV vaccines, specifically Gardasil.
I am an degenerate coffee addict. This has been so since I took my initial drink during my first chemistry finals as a college freshman. My coffee consumption hasn’t decreased much since then. I drink coffee because of its taste and the caffeine. Potential coffee health benefits are, personally, way down the list of reasons for drinking it. And frankly, I’m always skeptical of claimed health benefits for any food, unless there’s some really strong scientific evidence, which is generally lacking.
But recently, news outlets have been touting a couple of robust studies that seem to indicate that there are significant coffee health benefits. For those who know me, I rarely accept popular news sites analysis of scientific research. I think my loyal readers expect me to look at the science and see if there is any validity to the claims made by the press.
Claims about coffee health benefits and claims goes back centuries. It cured alcoholism. Coffee made you work longer. It was good for your heart. Drinking it was bad for your heart. It increases risks of some cancers. Wait, it decreases risks of some cancers. In other words, we really didn’t have vigorous evidence supporting anything definitive with respect to the drink’s health benefits or detriments.
It’s time to look at these two new studies and see what they tell us about drinking coffee.
Coffee health benefits – the first study
The first study we’re going to examine, from Gunter et al., published in the Annals of Internal Medicine. At a meta level, this epidemiological study was run by respected scientists, with the results published in a very high impact factor (17.2020) journal. Moreover, the study included around 520,000 participants in 10 European countries, which makes it one of the largest studies to date on coffee health benefits.
Compared to some of the horrifically bad studies that we have seen making outrageous claims about this or that food, drink or diet, this study is impressive. This is the kind of study that is equivalent to some of the best vaccine epidemiological research out there.
But what does the results say? To be blunt, they found that drinking more coffee would significant lower a person’s risk to all mortality.
The hazard ratio (HR), which compares the risk of dying between the coffee-drinking and non-coffee groups, was 0.88. In other words, there was a 12% reduction in all death causes in men who were in the upper quartile of coffee consumption. The HR for women in the upper quartile of consumption was 0.93, or a 7% reduction.
Frankly, a 12% or 7% difference in mortality is interesting and intriguing, but from a perspective of evidence-based medicine, it’s difficult to say this is clinically meaningful. However, if there are no known risks to coffee, which would have been uncovered by this study, the importance of those decreases in mortality become more substantial.
There were more significant results for certain diseases. The HR for coffee consumption and digestive disease mortality for men was 0.41 (a 59% reduction), and for women was 0.60 (a 40% reduction). Interestingly, for women, the HR for coffee drinking and circulatory disease mortality was 0.78 and cerebrovascular disease mortally was 0.70. However, the HR for coffee drinking and ovarian cancer mortality was 1.31, or a 31% increase.
The authors concluded, without much wiggle room:
Coffee drinking was associated with reduced risk for death from various causes. This relationship did not vary by country.
Review of the first study
Although the results appeared to fairly solid, I think it’s important to be critical of the results. First, we have no data that shows us whether or not coffee drinkers are just a healthier subgroup of people irrespective of their coffee drinking (they did separate out smokers from this study). Maybe coffee drinkers exercise more or eat less fats than the average person – these confounding factors have not examined carefully.
Second, like I discussed before, dose makes the poison, and dose also makes the medicine. Is there a level of coffee consumption at which point the risks outweigh the benefits? That’s not clear in this paper.
The best I could tell you from the data from this particular study of coffee health benefits is that if you’re a coffee drinker, maybe there is a slight decrease in risk of mortality, so keep on drinking. But if you don’t like coffee (yeah, there are those types around), or the caffeine effects of coffee are not to your liking, I’m not sure you should worry about suddenly taking up the habit.
Coffee health benefits – the second study
This second study, from Park et al., was also published in the Annals of Internal Medicine, once again, a very high quality journal. At a meta level, it’s as high quality as the study from Gunter et al., although this study looked at coffee consumption from a slightly different perspective.
Park et al. surveyed over 185,000 African-Americans, Native Americans, Hawaiians, Japanese-Americans, Latinos and whites, a broader ethic diversity than the first study. The researchers compared coffee consumption at various levels to a control group who drank no coffee. They adjusted for confounders such as smoking, age, alcohol intake, body mass intake, exercise, education and other factors.
For those who drank about 1 cup per day (in this case, they mean the English measurement of a cup, about 250 ml, not the standard “cup” in your local Starbucks which is about 500 ml), the HR was 0.88 or 12% reduction in total mortality. For 2-3 cups per day, the HR was 0.82. With consumption ≥ 4 cups per day, the HR was the same 0.82, or 18% reduction. All of these numbers were statistically significant.
Moreover, the researchers found that coffee increases longevity across various races.
Park et al. also found that drinking decaffeinated coffee had no effect, so you have to go for the real stuff to see these health effects.
The researchers concluded:
In summary, higher coffee consumption was associated with lower risk for all-cause death and death from heart disease, cancer, respiratory disease, stroke, diabetes, and kidney disease. Inverse associations were found in African Americans, Japanese Americans, Latinos, and whites; never-smokers, former smokers, and current smokers; those with preexisting heart disease or cancer; and healthy participants. Our findings support the recent dietary guidelines from the U.S. Department of Agriculture (33), which indicate that moderate coffee consumption can be integrated into a healthy diet and lifestyle, by confirming an inverse association with mortality and suggesting that association’s generalizability to different racial/ethnic groups.
Review of the second study
What I like about this study is that it had a better analysis of major confounders, which gives me more confidence that it’s showing a real decrease in mortality rates for coffee drinkers. Moreover, they have the semblance of a dose response which shows 3-4 cups probably gives you the best reduction in death rate, but I’d like to see much higher consumption, like 10 cups. Maybe there’s a lowered benefit as you drink more, so further research will be informative.
But I have to point out again, the reduction in mortality was, at best, 18%, which may not have any clinical significance.
Coffee health benefits – the summary
These two studies show that there is a strong biological possibility that there is some relationship between lowered mortality and coffee drinking. The European study showed that coffee lowered the risk of dying from liver disease, cancers in women, digestive diseases and circulatory disease.
Moreover, both studies showed that those who drank three or more cups a day had a lower risk for all causes of death than people who did not drink coffee.
Finally, we don’t know what compound in coffee has this protective effect against mortality. Coffee may contain over 200 different chemicals and compounds, and it might take decades of additional research to identify what chemical (or chemicals) in coffee may provide these health benefits.
I’m going to stand by my point that I previously made. These results are interesting, but they’re not overwhelming. The large numbers in both of these studies to give credibility to the quality of the statistical analyses, but still the risk reduction from drinking coffee seems less than impressive.
I think my skepticism would be reduced if I knew what may be the contributing factor – is it that coffee drinkers are just better people? Or is it some chemical in the coffee? Maybe unhealthy people don’t drink coffee because of a physician’s recommendation, which adds bias to these studies?
So at this time, drink coffee if you like it. It may provide you with some benefit. If you shouldn’t drink coffee, or don’t like it, I don’t think there is enough evidence for you to suddenly change your habits. Coffee health benefits are intriguing, but not quite overwhelming yet.
Gunter MJ, Murphy N, Cross AJ, Dossus L, Dartois L, Fagherazzi G, Kaaks R, Kühn T, Boeing H, Aleksandrova K, Tjønneland A, Olsen A, Overvad K, Larsen SC, Redondo Cornejo ML, Agudo A, Sánchez Pérez MJ, Altzibar JM, Navarro C, Ardanaz E, Khaw KT, Butterworth A, Bradbury KE, Trichopoulou A, Lagiou P, Trichopoulos D, Palli D, Grioni S, Vineis P, Panico S, Tumino R, Bueno-de-Mesquita B, Siersema P, Leenders M, Beulens JWJ, Uiterwaal CU, Wallström P, Nilsson LM, Landberg R, Weiderpass E, Skeie G, Braaten T, Brennan P, Licaj I, Muller DC, Sinha R, Wareham N, Riboli E. Coffee Drinking and Mortality in 10 European Countries: A Multinational Cohort Study. Ann Intern Med. 2017 Jul 11. doi: 10.7326/M16-2945. [Epub ahead of print] PubMed PMID: 28693038.
The interesting thing about social media (Facebook, Twitter, blogs, Google, reddit) is that it’s fairly easy to push pseudoscientific beliefs. The first problem is that many people read the headlines, and never the underlying discussion. If it can be said in 140 characters, or a misleading infographic, many individuals will share that across the internet as a “fact”. So, if you see an claim that “Polio vaccines infected 98 million Americans with a cancer virus,” many people will immediately see that an accept it without much criticism.
Of course, this leads to a second problem. To refute this claim takes a lot more than 140 characters. The refutation is often complex, nuanced and highly scientific, and may take 2000 words or more to blast the claim into orbit. It’s highly emotional to claim a vaccine can cause cancer. On the other hand, to say it is not isn’t emotional–it’s coldly logical. And takes a lot of words.
And the third problem is that is that social media fallacies have multiple lives, so when someone reads one of these memes a year from now, they think “yeah, this is great information”, and pass it along as if it’s the Truth. Killing zombie memes are just as difficult as killing zombies in real life, or at least, on a TV show. Debunking these zombie memes is a full-time job. And, once it’s been debunked, we move back to the first problem again, again, and again.
The IARC, one of the intergovernmental agencies within the World Health Organization, is widely respected for their research into the causes of cancer. And with respect to glyphosate, the IARC concluded that:
There was limited evidence in humans for the carcinogenicity of glyphosate. Case-control studies of occupational exposure in the USA, Canada, and Sweden reported increased risks for non-Hodgkin lymphoma that persisted after adjustment for other pesticides.
The AHS cohort did not show a signifi cantly increased risk of non-Hodgkin lymphoma. In male CD-1 mice, glyphosate induced a positive trend in the incidence of a rare tumour, renal tubule carcinoma.
A second study reported a positive trend for haemangiosarcoma in male mice. Glyphosate increased pancreatic islet-cell adenoma in male rats in two studies. A glyphosate formulation promoted skin tumours in an initiation-promotion study in mice. Glyphosate has been detected in the blood and urine of agricultural workers, indicating absorption.
Glyphosate and glyphosate formulations induced DNA and chromosomal damage in mammals, and in human and animal cells in vitro. One study reported increases in blood markers of chromosomal damage (micronuclei) in residents of several communities after spraying of glyphosate formulations.
The Working Group classified glyphosate as “probably carcinogenic to humans” (Group 2A).
Unfortunately, when the IARC made its decision two years ago, there was one major problem. According to an extensive article by Kate Kelland in Reuters, one of the members of the IARC’s study group looking at glyphosate knew of recently published data that showed no link between the weed killer and cancer. Aaron Blair, an epidemiologist from the US National Cancer Institute, never mentioned this new data to the study group examining whether glyphosate causes cancer. So the IARC made its decision without all of the available evidence.
Reuters obtained information that lead it to state that:
Previously unreported court documents reviewed by Reuters from an ongoing U.S. legal case against Monsanto show that Blair knew the unpublished research found no evidence of a link between glyphosate and cancer. In a sworn deposition given in March this year in connection with the case, Blair also said the data would have altered IARC’s analysis. He said it would have made it less likely that glyphosate would meet the agency’s criteria for being classed as “probably carcinogenic.”
The IARC acts in a manner that it appears to develop a scientific consensus about what may increase the risks of cancer. As I have mentioned many times, the scientific consensus is a powerful tool in providing us with the collective conclusions of top scientists in a field. However, this consensus must be based on evidence, not opinion or belief. And if a consensus is “proclaimed” without consideration of all of the high quality evidence, then it’s hard to put much value in it.
Now there wasn’t a grand conspiracy that blocked the IARC from considering this new evidence. Blair himself was a senior researcher on the study that showed no link between cancer and glyphosate. The reason the research wasn’t included was simple – the IARC only uses published data to come to its consensus about cancer risk, and Blair’s research could not be included in the discussion. This leads to increased transparency and reduces the risk of claims of “secret evidence” that may lead to accusations of bias.
Now, this rule may seem onerous to some, it does keep the discussion to peer-reviewed data, ignoring data that hasn’t been vetted. This probably works both ways, leaving out data that may move a chemical into a cancer causing category or not.
But this decision by the IARC had some significant consequences. First, it’s hard to read anything about GMO foods, agriculture, or food without someone spouting off that “glyphosate causes cancer.” In fact, there’s a class action lawsuit in California, with 184 individual plaintiffs, who use the IARC analysis on glyphosate, claiming that exposure to the chemical gave them cancer. The plaintiffs allege Monsanto failed to warn consumers of the risks of RoundUp, which Monsanto fiercely denies.
Monsanto claims that the fresh data should have been published in time for use in IARC deliberations on glyphosate. Or, at the minimum, the preliminary data should have been evaluated, considering Blair’s involvement with both the IARC and the new research.
Again, according to Reuters,
The company also goes beyond saying the fresh data should have been published. It told Reuters the data was deliberately concealed by Blair, but provided no specific evidence of it being hidden.
So this gets a bit more troubling.
What did Aaron Blair do? And why?
This is what is troubling to me. Actually, the data that mostly refuted the hypothesis that glyphosate causes cancer was available two years before the IARC assessment meeting. Now, science does move slowly, but that’s glacial.
According to Blair, the data was not published in a timely manner because there was too much data to fit into one scientific paper (which seems like a lame excuse to this writer). Reuters actually asked whether “he deliberately did not publish it to avoid it being considered by IARC.” Of course, Blair denied it. Furthermore, the National Cancer Institute also stated that “space constraints” was one of the reasons why the new data on glyphosate was not published in a timely manner.
Of course, the absence of Blair’s data was a critical oversight – the IARC ended the meeting by concluding that the weed killer is a “probably human carcinogen.”
In fact, the statement based its findings on “limited evidence” of carcinogenicity in humans, but “sufficient evidence” in animal research models. It specifically stated that there was a “positive association” between glyphosate and non-Hodgkin lymphoma, a cancer of the blood.
Beyond the litigation mentioned above, the IARC had all kinds of negative consequences. For example, some countries have pending decisions regarding whether to relicense or ban sales of glyphosate. Some countries have even restricted glyphosate’s use in home gardens and on crops immediately prior to harvest.
And back to the class action lawsuit in California, Reuters reports that:
… (the) California judge took the IARC assessment into account in a separate legal case in March when ruling that the state can require RoundUp to carry a warning label that it may cause cancer. Monsanto is now facing further litigation from hundreds of plaintiffs across the United States who say glyphosate gave them or their loved ones non-Hodgkin lymphoma, citing the IARC assessment as part of their claims.
All, because of an apparently flawed decision without all of the high quality evidence considered. This is frustrating from a scientific standpoint.
What is in Blair’s study?
This unpublished research, and it’s still unpublished, came from the Agricultural Health Study, a large multi-center study led by scientists at the National Cancer Institute. The researchers examined agricultural workers and their families, in the USA, who were exposed to various agricultural chemicals, including glyphosate. Blair himself agreed that the unpublished data showed “no evidence of an association” between exposure to glyphosate and non-Hodgkin lymphoma.
In fact, a review by Acquavella et al., published in 2016, examined the body of research regarding glyphosate and non-Hodgkin lymphoma. The authors concluded that, “overall, our review did not find support in the epidemiologic literature for a causal association between glyphosate and non-Hodgkin lymphoma or multiple myeloma.” That’s a pretty powerful finding with regards to the IARC decision.
Additionally, Robert Tarone also published a paper in 2016 that took IARC’s decision regarding glyphosate to task. He concluded that,
It is shown that the classification of glyphosate as a probable human carcinogen was the result of a flawed and incomplete summary of the experimental evidence evaluated by the Working Group. Rational and effective cancer prevention activities depend on scientifically sound and unbiased assessments of the carcinogenic potential of suspected agents. Implications of the erroneous classification of glyphosate with respect to the IARC Monograph Working Group deliberative process are discussed.
The IARC’s decision that glyphosate causes cancer seems to be under attack by serious researchers.
Blair admitted, while being deposed by Monsanto lawyers, that IARC’s review of whether glyphosate causes cancer would have been different if the Agricultural Health Study data were included. According to Blair, the addition of the missing data would have “driven the meta-relative risk downward.” In non-scientific terms, that means meta-data would have shown a reduced correlation between glyphosate and non-Hodgkin lymphoma.
Essentially, the IARC review ignored a huge body of robust data from a comprehensive study on exposure to glyphosate, and it’s relationship to cancers. This is a major oversight of the IARC decision.
And it’s just shocking to note that one person, Aaron Blair, was on the IARC review committee and had insider access to high quality data that refuted the IARC’s claims of correlation (and causation) between glyphosate and cancer.
Reuters took the data (which, as I stated, still has not been published, although the NCI told Reuters that they are currently working on an updated analysis) to two statistical experts to determine what it may say about whether glyphosate causes cancer. Neither of the experts had seen the data, and neither had a conflict of interest with respect to glyphosate or Monsanto.
The experts came to two key conclusions after examining the data:
There was “no apparent scientific preseason for not publishing the data” from the large study. In other words, absent some issue like bias or bad study design, they felt that the data was publishable in its current form.
The data shows no evidence that glyphosate causes cancer, especially non-Hodgkins lymphoma.
Of course, you’d think that the IARC would reconsider it’s decision about glyphosate, relying upon all the science, not just what they had already decided. Apparently, that’s not going to happen.
Reuters wrote to the IARC about Blair’s new data and whether they would reconsider their position. They responded by email,
IARC declined to say whether Blair informed IARC staff about the unpublished data, whether he should have, and whether that data might have changed IARC’s evaluation of glyphosate had it been published in time. The agency said it had no plans to reconsider its assessment of the chemical.
That’s not very scientific. The consensus must change with new, high quality data. It seems like the IARC is being stubborn about their decision rather than looking at more robust evidence that contradicts their conclusions.
Glyphosate causes cancer – the Summary
As I wrote in 2015, without the data from the Agricultural Health study, I, and other researchers, felt that the IARC decision was suspect. It seemed to rely upon very weak associations between glyphosate and non-Hodgkin lymphoma, while ignoring high quality evidence that showed no correlation.
With this data, as yet unpublished, the IARC’s decision about the carcinogenicity of glyphosate just doesn’t pass scientific credibility.
I hope that when Blair’s study finally gets published, the IARC will review its findings and follow the science to a more defensible conclusion. What should trouble the IARC is that many scientists are starting to look askance at their decisions regarding carcinogens. The evidence just doesn’t support their conclusions on glyphosate, but what if their decisions about other chemicals is also this badly done?
Monsanto glyphosate (Roundup) is a broad-spectrum systemic herbicide used to kill weeds, especially annual broadleaf weeds and grasses that are known to compete with commercial crops grown around the world. It has several advantages over many herbicides in that it breaks down in the soil into non-toxic organic molecules, reducing or eliminating contamination of groundwater and lower soils.
Monsanto has developed genetically modified (GMO) grains that are resistant to glyphosate, so that agriculture can apply the herbicide to kill the competitive weeds while not harming the crop. This allows farmers to suppress the weeds while allowing better production out of the grain crop.
Whatever the benefits of Monsanto glyphosate, GMOs and the herbicide are tied together in many minds. And there has been an ongoing effort by many people to claim that glyphosate causes cancer. But let’s look at the science, because maybe we’ll get some information.
It has been well established that human papilloma virus (HPV) is closely linked to numerous cancers. Recently, evidence has been uncovered that show a link between HPV and prostate cancer. This provides us with more evidence that preventing these infections with the HPV vaccine can lead to a reduction in many types of cancers in both men and women.
Because vaccine deniers lack any scientific evidence supporting their unfounded belief system about immunizations, they tend to rely upon unscientific information like anecdotes, logical fallacies, misinterpretation of data, or Italian provincial courts to make their case about the lack of safety of vaccines. One of the latest ones involves a so-called lead Gardasil researcher, Dr. Diane Harper, a former “consultant” to Merck (and GSK, who manufacturers Cervarix, a bivalent HPV vaccine), who apparently had some research role in the clinical trials of the HPV vaccines. But what are the facts?
It’s rather easy to debunk these claims, but because of the nature of the internet, old news is recycled as “brand new,” requiring a whole new round of blog posts to discredit the misinformation. It’s impossible to recall one single instance where a vaccine refuser made a statement about vaccines that was not, in fact, rather quickly debunked. Not one.
Subjectively, one the wilder claims one can find on social media is that marijuana cures cancer. Or cannabis prevents cancer. It doesn’t matter what form – smoked, eaten, hemp oil (which is manufactured from the seeds of cannabis plants that don’t contain much THC, or tetrahydrocannabinol, the active hallucinogenic agent of cannabis) – some advocates for cannabis will try to make the argument that it is some miracle drug for cancer.