The US Food and Drug Administration recently announced (pdf) that it had cleared 35 new drugs during 2012, of which 31 were novel therapies. This is in addition to the literally hundreds of approvals for changes in already approved drugs for changes in packaging, manufacturing, and dozens of other reasons.
In no particular order, here are the top 10 most interesting of the approvals based on my subjective viewpoint, which includes innovativeness, seriousness of disease, and other random factors. In others, no different in importance than all those end-of-year top 10 movie lists. So here we go: Continue reading “2012 Top Ten list for new drug approvals”
Every once in a while, there’s a story that’s so unbelievable, it almost sounds like a myth of legendary proportions. Let me try to write this without laughing.
Each day, I receive news feeds from Google with articles from all over the web regarding my favorite issues. Vaccines, vaccinations, politics, sports, and whatever interests me. The feeds are very specific, so sometimes there are just a couple of articles, sometimes, especially with vaccinations, there are literally several dozen. I scan the headlines, and some become articles here.
One of my feeds is simply “GMO,” or genetically modified crops, which are foods derived from genetically modified organisms (GMOs). All types of agricultural breeding induces genetic modification, but in general, GMO usually implies actual manipulation of the genes. GMO’s are a major controversy because of the use of DNA recombination-introducing genes from one species into another, which usually provides crops with added advantages, such as resistance to pests. A few weeks ago, when the thoroughly debunked “GMO corn causes cancer” story hit the interwebs, and my GMO news feed was filled with articles. Lately, it’s dropped down to a handful. Continue reading “GMO opponents fall for a hoax”
Here we go again with high fructose corn syrup (HFCS), one of the food substances that, along with GMO and MSG, forms the evil tripartite of food substances in the minds of some. And like the overhyped, and subsequently thoroughly debunked, article that tried to link GMO crops to cancers in rats, there is a new a paper
But first, what is high fructose corn syrup? I wrote about HFCS a few weeks ago, debunking some of the myths about HFCS with real science.
Basically, HFCS consists of 24% water, and the rest fructose and glucose. There are two main types of HFCS, HFCS 55 (used mostly in soft drinks) which is approximately 55% fructose and 42% glucose; and HFCS 42 (used in other types of beverages and processed foods), which is approximately 42% fructose, and 53% glucose. There is another type, HFCS-90, approximately 90% fructose and 10% glucose, which is used in small quantities for specialty applications (interestingly, low calorie drinks, because, for the same sweetness about 33% less calories are added), but it is primarily blended with HFCS 42 to make HFCS 55.
Over the past couple of weeks, I have discussed a study by Gilles-Eric Séraliniet al. published in Food and Chemical Toxicology that concluded that glyphosate-resistant NK603 GMO corn developed by Monsanto causes severe diseases such as tumors in rats. Of course, the study was picked up by many anti-science groups and broadcast widely as “GMO foods cause cancer.”
The biggest criticism from both reviews is that Séralini and his team used only ten rats of each sex in their treatment groups. That is a similar number of rats per group to that used in most previous toxicity tests of GM foods, including Missouri-based Monsanto’s own tests of NK603 maize. Such regulatory tests monitor rats for 90 days, and guidelines from the Organisation for Economic Co-operation and Development (OECD) state that ten rats of each sex per group over that time span is sufficient because the rats are relatively young. But Séralini’s study was over two years — almost a rat’s lifespan — and for tests of this duration, the OECD recommends at least 20 rats of each sex per group for chemical-toxicity studies, and at least 50 for carcinogenicity studies.
Moreover, the study used Sprague-Dawley rats, which both reviews note are prone to developing spontaneous tumours. Data provided to Nature by Harlan Laboratories, which supplied the rats in the study, show that only one-third of males, and less than one-half of females, live to 104 weeks. By comparison, its Han Wistar rats have greater than 70% survival at 104 weeks, and fewer tumours. OECD guidelines state that for two-year experiments, rats should have a survival rate of at least 50% at 104 weeks. If they do not, each treatment group should include even more animals — 65 or more of each sex.
“There is a high probability that the findings in relation to the tumour incidence are due to chance, given the low number of animals and the spontaneous occurrence of tumours in Sprague-Dawley rats,” concludes the EFSA report. In response to the EFSA’s assessment, the European Federation of Biotechnology — an umbrella body in Barcelona, Spain, that represents biotech researchers, institutes and companies across Europe — called for the study to be retracted, describing its publication as a “dangerous case of failure of the peer-review system”.
The numerous issues relating to the design and methodology of the study as described in the paper mean that no conclusions can be made about the occurrence of tumours in the rats tested.
Therefore, based on the information published by the authors, EFSA does not see a need to re-examine its previous safety evaluation of maize NK603 nor to consider these findings in the ongoing assessment of glyphosate.
“The design, reporting and analysis of the study, as outlined in the paper, are inadequate,” said the EFSA in a press release, and added that the paper is “of insufficient scientific quality to be considered as valid for risk assessment”.
On the basis of the publication, the BfR has come to the conclusion that the authors’ main statements are not sufficiently corroborated by experimental evidence. In addition, due to deficiencies in the study design and in the presentation and interpretation of the study results, the main conclusions of the authors are not supported by the data.
Séralini refuses to release any of his data for public scrutiny, which is highly unusual for peer-reviewed research. One of the most important features of science is being open to the bright lights of criticism, which means review of data. I guess Séralini isn’t really happy that his research is being blasted by scientists worldwide, since the design, analysis, statistics, and conclusions barely met the standards of a high school science fair.
Scientific denialism (also known as pseudoskepticism) is the culture of denying an established scientific theory, law or fact despite overwhelming evidence, and usually for motives of convenience. Sometimes those motives are to create political gain for their supporters.
Two of the most annoying denier viewpoints are the darlings of the right wing: evolution denialism and global warming denialism. The former is more commonly known as creationism and is mostly an American phenomenon, though it is known in other countries. In the US, creationism is a fundamental part of the Republican Party strategy across the country. The latter is sometimes mistakenly called global warming skepticism, because “skeptic” was stolen by the pseudoskeptics, but plainly is a right-wing belief across the world, often intersecting closely with the evolution deniers. In fact, much of the anti-evolution legislation pushed by Republican legislatures in the United States has an anti-global warming component.
Global warming or evolution is supported by a massive mountain of scientific evidence. Both are theories that are ” well-substantiated explanations of some aspect of the natural world, based on a body of facts that have been repeatedly confirmed through observation and experiment.” As I have stated before, rhetoric and debate are not going to refute these theories. We demand scientific data, produced in world class laboratories that have been published in top tier, high quality journals, subject to withering criticism. After time, they will either be accepted into the body of evidence or rejected. That’s how science works. It’s not a political debate where the person with the loudest voice wins. Continue reading “GMO opponents are the global warming denialists of the left”
Four hundred years ago, the world was so afraid of Galileo’s scientific ideas that the Catholic Church put him under house arrest for the rest of his life. And he was just describing heliocentrism, the astronomical model where the earth revolves around the sun. Very important to our understanding of the universe, but it was not a life or death matter. You would assume that if a new scientific idea that would help people live longer and healthier, then there would be no fear. However, that assumption is disproven again and again with the anti-vaccine gang and the Big Pharma ad hominems that we hear frequently.