Archive for Basic Science

The 21st Century Cures Act: The (Somewhat) Good, The (Mostly) Bad, and The (Very) Ugly

The 21st Century Cures Act: Unnecessary and misguided.

The 21st Century Cures Act: Unnecessary and misguided.

The approval of new drugs and medical devices is a process fraught with scientific, political, and ethical landmines. Inherent in any such process is an unavoidable conflict between rigorous science and safety on the one side, which tend to slow the process down by requiring large randomized clinical trials that can take years, versus forces that demand faster approval. For example, patients suffering from deadly diseases demand faster approval of drugs that might give them the hope of surviving their disease, or at least of surviving considerably longer. This is a powerful force for reform, as evidenced by HIV/AIDS activism in the 1980s and 1990s that led to the development of fast-track approval mechanisms for drugs for life-threatening conditions, a change whose effects have been mixed. It’s also a powerful force potentially for ill, as I’ve documented in my posts about the understandable but misguided “right-to-try” movement. After all, what politician can say no to a constituency representing desperately ill people who only want a shot at survival? It’s not all desperate patients, however. Also wanting more rapid drug approval are powerful business interests in the form of the pharmaceutical and medical device industries, for whom the time and expense of prolonged clinical trials eat into profits and make some drugs not worth developing from a business standpoint.

In 1962, after Frances O. Kelsey, MD, PhD (who died on Friday at the age of 101) successfully prevented the approval of the drug thalidomide in the US, a drug found to cause serious birth defects, Congress passed the Kefauver-Harris Drug Amendments to the Federal Food, Drug, and Cosmetic Act. These amendments required that drug companies not just show safety before their drugs could be FDA-approved, as had been the case prior to the amendments, but also to provide substantial evidence of effectiveness for the product’s intended use. That evidence had to be in the form of adequate and well-controlled clinical trials, which at the time was considered a revolutionary requirement. (Believe it or not, no requirement for high quality clinical trials existed before 1962.) This led to the current system of phase I, II, III, and IV clinical trials in force in the United States today. The amendments also included a requirement for informed consent of study subjects and codified good manufacturing processes, as well as the requirement that adverse events be reported. This has been, with some tweaking over the years, the law of the land regarding how the FDA approves drugs for specific indications

Medicine is a lot more complex now than it was in the 1960s however, and there has been a growing sentiment that the system is, if not broken, at least functioning in a way that is behind the times, a manner that was acceptable and appropriate 40 years ago but is no longer so in this era of genomics, precision medicine (formerly known as “personalized medicine”), and targeted therapies. The new drug approval process, which can take up to a decade and cost a billion dollars, it is argued, is too rigid, cumbersome, and slow for the 21st century. (Why it wasn’t too rigid, cumbersome, and slow in the 20th century, no one seems to say. I guess that “21st century” sounds way cooler.)

Into this ongoing controversy have marched Rep. Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.), who have sponsored a bill passed by the House of Representatives in a rare display of bipartisanship in July. The bill, H.R.6, is entitled the “21st Century Cures Act“. Given how it passed the House by a vote of 344-77, one would think that it should glide through the Senate easily. Certainly, its sponsors and supporters have mounted a mighty PR effort. That might not be the case, given that in the Senate a single senator can hold up or even kill a bill through a filibuster, and to shut down a filibuster or prevent a threatened filibuster requires 60 votes. Be that as it may, I’m not so much interested in the politics of this bill, which, if it survives the Senate, will almost certainly be significantly amended, but rather what the bill does.

Posted in: Basic Science, Clinical Trials, Politics and Regulation

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ASEA, ORMUS, and Alchemy

Ormus powder. “Ormus could be the source of all metals. Therefore, we identify the Ormes elements in relationship to the metal they can unfold into (e.g. Ormus copper, Ormus gold, Ormus rhodium, etc.)”

An example of Ormus powder. “Ormus could be the source of all metals. Therefore, we identify the Ormus elements in relationship to the metal they can unfold into (e.g. Ormus copper, Ormus gold, Ormus rhodium, etc.)”

I got an e-mail from a woman who had read my article on ASEA, a multilevel marketing diet supplement that I characterized as an expensive way to buy water.  She had not tried ASEA products but was applying for a position as an accountant with the company, and she chastised me for not doing my due diligence and researching the new science of ORMUS.

First she dismissed science, saying “science as we know it is no longer valid and quantum physics clearly shows this.” Then she claimed there was valid science that would support ASEA’s claims. She had personally done a sea salt cleanse with good results. If ASEA is only salt water, that doesn’t negate its validity, since ORMUS material is from sea salt and when minerals are rearranged they no longer register as the original element. Alchemy is not a myth, and the “quantum non-mainstream sciences” prove it is real. Quantum physics “explains that particles can interact without actually being on contact, this is a form or property of superconductivity.” She thinks ORMUS material is superconductive and constitutes a percentage of the human brain mass, allowing transmission of thoughts to others who tune in to these superconductive energy transmissions.

But wait, there’s more! She went on to tell me about an experiment where a dog’s entire blood volume was replaced by seawater. She shared her belief that the power of the mind can heal all disease, and she explained that she relies on a natural knowing within herself and only uses outside evidence to confirm her beliefs. She has been studying subjects like sacred geometry, Vedic mathematics, the golden ratio, quantum physics, and extraterrestrials.

Orbitally Rearranged Monoatomic Elements

This woman is obviously misguided and misinformed, but what is this ORMUS she’s talking about? I’d never heard of it, so I started with Rational Wiki:

ORMUS, also called ORMEs (Orbitally Rearranged Monoatomic Elements) and m-state materials, is a fictitious group of substances exhibiting many miraculous properties, such as healing powers and superconductivity at room temperature. They were supposedly discovered in 1975 by David Hudson, a cotton farmer from Arizona.


Posted in: Basic Science, Energy Medicine, Herbs & Supplements

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Bastions of quackademic medicine: Georgetown University

The cover of Georgetown Medicine Spring/Summer 2015 issue. This image will drive Mark Crislip crazy, as it features yet another acupuncturist not using gloves while sticking needles into people. Dr. Gorski loves watching Dr. Crislip's reactions to such photos.

The cover of Georgetown Medicine Spring/Summer 2015 issue. This image will drive Mark Crislip crazy, as it features yet another acupuncturist not using gloves while sticking needles into people. Dr. Gorski loves watching Dr. Crislip’s reactions to such photos.

We frequently discuss a disturbing phenomenon known as quackademic medicine. Basically, quackademic medicine is a phenomenon that has taken hold over the last two decades in medical academia in which once ostensibly science-based medical schools and academic medical centers embrace quackery. This embrace was once called “complementary and alternative medicine” (CAM) but among quackademics the preferred term is now “integrative medicine.” Of course, when looked at objectively, integrative medicine is far more a brand than a specialty. Specifically, it’s a combination of rebranding some science-based modalities, such as nutrition and exercise, as somehow being “alternative” or “integrative” with the integration of outright quackery, such as reiki and “energy healing,” acupuncture, and naturopathy, into conventional medicine. As my good bud and fellow Science-Based Medicine (SBM) blogger Mark Crislip put it, mixing cow pie with apple pie does not make the cow pie better, but we seem to be “integrating” the cow pie of quackery with the apple pie of science-based medicine thinking that somehow it will improve the smell, taste, and texture of the cow pie.

I remember how, when I first discovered how prevalent outright pseudoscience and quackery had become in medical academia (which was before I became one of the founding SBM bloggers), I was in denial. I couldn’t believe it. Then I tracked this phenomenon with something I called the Academic Woo Aggregator. It turned out to be a hopeless endeavor because, as I soon discovered, the phenomenon was so pervasive that it was really hard to keep the Aggregator up to date. Since then, I’ve generally only focused on particularly egregious examples, naming names when institutions like my alma mater embrace anthroposophic medicine; “respectable” journals publish “integrative medicine” guidelines for breast cancer patients; cancer organizations include “integrative oncology” in their professional meetings; NCI-designated comprehensive cancer centers promote reiki to pediatric cancer patients or offer high dose unproven vitamin C treatment to patients; or respected academic institutions embrace traditional Chinese medicine (TCM) and the quackery that is function medicine. You get the idea. It’s depressing just how far medical academia has fallen in terms of being “open-minded” to the point of brains falling out when it comes to medical pseudoscience.

Posted in: Acupuncture, Basic Science, Energy Medicine, Homeopathy, Medical Academia

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Aging and Longevity: Science for Spring Chickens

Spring Chicken

We’re all going to die, but we don’t like to think about it. I’ll reach the proverbial threescore years and ten next month, so I’ve been thinking more about it, wishing I knew some reliable way to ensure that I would live many more years and remain fully functional until I suddenly collapsed like the Deacon’s wonderful one-hoss shay. There are myriad “longevity clinics” and “anti-aging” formulas, and every centenarian has an explanation that is the direct opposite of some other centenarian’s explanation. But what does the scientific evidence say? In his new book Spring Chicken: Stay Young Forever (Or Die Trying), Bill Gifford has done us a great service by investigating the latest scientific evidence about aging and presenting his findings in an engaging narrative form. He interviews some of the major players and introduces us to health fanatics who are convinced they can prolong their lives by doing things like monitoring their own blood cholesterol levels on a weekly basis, exercising obsessively, severely restricting their calorie intake, fasting intermittently, deliberately exposing themselves to stress like swimming in icy water, competing in extreme athletics, taking boatloads of hormones and supplements, experimenting on themselves with investigational drugs, and doing other questionable and sometimes bizarre things.

Are there limits to human life expectancy?

There is no documented case of anyone living longer than Jeanne Calment of France, who died at the age of 122. Jay Olshansky thinks biological forces limit how long we can live. Aubrey de Grey thinks some people alive today will live to be a thousand years old. Gifford explains the controversy and the reasoning behind both sides. Will we someday be able to re-engineer human biology to overcome the limits? The jury is still out. (more…)

Posted in: Basic Science, Book & movie reviews

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The measles vaccine protects against more than just the measles

Vaccines Protect

One of the disadvantages of writing for this blog is that sometimes I feel as though I spend so much time deconstructing bad science and pseudoscience in medicine that I’m rarely left with the time or the opportunity to discuss some interesting science. Of course, even when I do that, usually it’s in the context of that very same bad science or pseudoscience, and this post won’t be different. Still, there was some interesting science with respect to vaccines published last week in Science, and I think it’s worth looking over. The only thing that surprises me is that the antivaccine movement hasn’t jumped all over it yet. On the other hand, its press coverage was relatively minimal, and I didn’t really notice it until an article appeared on (sadly, yes) The Huffington Post entitled “The Measles Vaccine Can Protect Against Much More Than Measles, According To New Study“:

A new study suggests the measles shot comes with a bonus: By preventing that disease, the vaccine may also help your body fight off other illnesses for years.

It’s long been known that contracting measles weakens the immune system for weeks or months, putting people, especially children, at increased risk for potentially fatal infection by a host of germs.

Now, scientists find that this vulnerable period goes on much longer than thought, up to three years. So the benefit of avoiding measles also extends longer than was appreciated. Researchers also found that measles vaccination campaigns were followed by a drop in deaths for other infectious diseases.

Experts said the work is a wake-up call to parents who don’t vaccinate their children out of unfounded fears about a link between vaccines and autism.


Posted in: Basic Science, Vaccines

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Angelina Jolie, surgical strategies for cancer prevention, and genetics denialism (revisited)

Angelina Jolie

Angelina Jolie

Sometimes, weird things happen when I’m at meetings. For example, I just got home from the Society of Surgical Oncology (SSO) meeting in Houston over the weekend. Now, one thing I like about this meeting is that, unlike so many other meetings these days—cough, cough, ASCO, I’m looking at you—at the SSO there wasn’t a single talk I could find about “complementary and alternative medicine” (CAM) or, as its proponents like to call it now, “integrative medicine.” It’s also a great chance to get caught up on new science and clinical guidelines in cancer surgery, as well as to see people I tend only to see at these meetings.

However, I must admit that by the last day I tend to be “meeting-ed” out and sometimes my attention wanders. Unfortunately, there are ample ways to indulge that attention deficit. Actually, it’s my iPhone. And it’s Twitter. So it was an odd coincidence that right after a talk by Dr. Deanna Attai about whether surgical oncologists can or should offer genetic counseling services to their patients, when I somehow let myself get into an exchange with Sayer Ji, the “natural health expert” responsible for GreenMedInfo, over BRCA1 mutations and the risk of breast and ovarian cancer, in other words, exactly the sort of thing that Dr. Attai had just discussed. For example:

After a bit of back-and-forth, I got fed up:

This minor Twitter exchange came about because of Angelina Jolie’s announcement in a New York Times op-ed last week entitled “Diary of a Surgery” that she had had her ovaries removed to prevent ovarian cancer due to her being a carrier of a high-risk mutation in BRCA1. As you might recall, I wrote about Jolie’s case two years ago, when she first announced in a NYT op-ed entitled “My Medical Choice” that she had undergone a bilateral mastectomy with reconstruction to decrease her BRCA1-related risk of breast cancer. Although I had discussed the story before, I thought it worth doing again here in a bit more detail. (more…)

Posted in: Basic Science, Cancer, Surgical Procedures

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Psychology Journal Bans Significance Testing

p-valuesThis is perhaps the first real crack in the wall for the almost-universal use of the null hypothesis significance testing procedure (NHSTP). The journal, Basic and Applied Social Psychology (BASP), has banned the use of NHSTP and related statistical procedures from their journal. They previously had stated that use of these statistical methods was no longer required but can be optional included. Now they have proceeded to a full ban.

The type of analysis being banned is often called a frequentist analysis, and we have been highly critical in the pages of SBM of overreliance on such methods. This is the iconic p-value where <0.05 is generally considered to be statistically significant.

The process of hypothesis testing and rigorous statistical methods for doing so were worked out in the 1920s. Ronald Fisher developed the statistical methods, while Jerzy Neyman and Egon Pearson developed the process of hypothesis testing. They certainly deserve a great deal of credit for their role in crafting modern scientific procedures and making them far more quantitative and rigorous.

However, the p-value was never meant to be the sole measure of whether or not a particular hypothesis is true. Rather it was meant only as a measure of whether or not the data should be taken seriously. Further, the p-value is widely misunderstood. The precise definition is:

The p value is the probability to obtain an effect equal to or more extreme than the one observed presuming the null hypothesis of no effect is true.


Posted in: Basic Science, Clinical Trials, Science and Medicine

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Skeptic’s Guide to Debunking Claims about Telomeres in the Scientific and Pseudoscientific Literature

The New Year starts with telomeres as the trendiest of trendy biomarkers. As seen in Time, telomeres are the means to monitor our well-being so we can protect ourselves from all sorts from threats, including early death.

A skeptic needs to do considerable homework in order to muster the evidence needed to counter the latest exaggerated, premature, and outright pseudoscientific claims about telomere length being a measure of “cellular aging” and therefore how long we’re going to live.


What is a telomere and why does its length matter?

Harriet Hall recently described telomeres:

Every chromosome has a telomere, a repeated sequence of nucleotides at the end of the DNA strand. It is a disposable section that carries no genetic information. For vertebrates, the nucleotide sequence is TTAGGG; this repeats from 300 to several thousand times according to the species of animal. Telomeres are sort of like the aglet, that little hard piece on the end of a shoelace that keeps it from unraveling. They protect the end of the chromosome and keep it from losing important genes or sticking to other chromosomes.

By Ian W. Fieggen (Own work) [GFDL ( or CC BY-SA 3.0 (], via Wikimedia Commons

Telomeres are sort of like aglets. Photo by Fieggen CC BY-SA 3.0 via Wikimedia Commons

Talk of telomeres isn’t just being used to sell dubious diagnostic tests and dietary supplements. There is a strong push to make telomere length the currency of how we think, measure, and do science about our health and well-being, and how we target our health interventions. Strong efforts are made to attach the science of telomeres to urgings that we take up yoga, meditation, and “being there” to save our lives.


Posted in: Basic Science, Nutrition, Science and Medicine, Traditional Chinese Medicine

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Is cancer due mostly to “bad luck”?

One of the more difficult conversations to have with a patient as a cancer doctor occurs when a patient, recently informed of her diagnosis of, for example, breast cancer, asks me, “Why did I get this? What caused it?” What almost inevitably follows is an uncomfortable conversation in which explanations of the multiple known causes of breast cancer do not satisfy the patient. The reason, of course, is because when a patient asks, “What caused it?” she doesn’t mean what causes breast cancer in general or in statistical terms. Rather, she means, what caused my breast cancer? It’s a question that can only occasionally be answered. For instance, if it’s lung cancer and the patient is a smoker, then it was almost certainly smoking that caused the cancer, because lung cancer is a relatively rare cancer in the absence of smoking. In the case of breast cancer, contrary to the prevailing belief that leads women with breast cancer to be puzzled about how they could get it when there’s “no cancer” in their families, only around 5-10% of cases have a familial or genetic component. That means that around 90% of breast cancers are what we call “sporadic,” which means that we can’t identify a specific cause. Or, as I like to say, “We just don’t know.” Worse, in the case of breast cancer, the environmental factors we know about appear to contribute modestly at best to the risk of cancer. (More on this later.)

Understandably, patients hate hearing “We just don’t know,” some vague handwaving about genes, and that there is nothing that we know of that they did that caused their cancer. People—including oncologists—really don’t like the concept of “sporadic” cancer, mainly because humans crave explanation. The default assumption is that everything must happen for a reason and there must be a cause for every disease or cancer. Perhaps the most ridiculously emphatic statement of this that I’ve encountered thus far comes from (who else?) über-quack Mike Adams when he heaped contempt on the idea of sporadic disease as “spontaneous disease.” He did this in the context of a story describing how, after Dr. Mehmet Oz had followed recommended care and undergone screening colonoscopy to look for polyps, he was shocked that he actually had some. This led Adams, in his usual inimitable fashion, to construct a straw man so massive that it could be seen from space when he set it on fire, declaring that “colon polyps, in other words, appear without any cause!” and that “mainstream medicine…believes in the theory of ‘spontaneous disease’ that ‘strikes’ people at random.”

Not exactly.

On the other hand, there is a lot of randomness in disease, not just cancer, as hard as it is for Mike Adams, or anyone to accept. Just because there is a varying amount of randomness in who gets a disease does not mean that mainstream medicine claims there is no cause to these diseases. Rather, for diseases like cancer, it’s a stochastic process, meaning that chance can play a role—sometimes a big role—in determining who gets sick. Indeed, just last week there was more evidence supporting this idea published in Science. Unfortunately, much of the mainstream press coverage presented the message of the paper a bit too simplistically. Even more unfortunately, it was the authors who encouraged this, as did the Johns Hopkins University press release about the study, which was entitled “Bad Luck of Random Mutations Plays Predominant Role in Cancer, Study Shows“. Yes, I groaned when I read this title.

Posted in: Basic Science, Cancer, Epidemiology, Science and the Media

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Selective pressures on alternative medicine


(Editor’s note: I was away at Skepticon over the weekend, where I gave a talk entitled “The Central Dogma of Alternative Medicine”. (When the talk’s up on YouTube, I’ll provide a link, of course.) Because of all the fun and travel delays I didn’t get a chance to turn my slides and notes into a blog post yet. Also, I’m on vacation this week. However, this gives me the opportunity to resurrect a blog post from 2007 on my not-so-super-secret other blog, because I think the concept is interesting. I even use it in a slide that shows up in many of my talks (above). I’ve updated dead links and added some text to include relevant links to posts written since. Enjoy, and I’ll definitely be back next week with original material, if not sooner, given that there are others here who might have the temerity to take part or all of this week off.)

I wish I had thought of this one, but I didn’t. However, I never let a little thing like not having thought of an idea first to stop me from discussing it (even if Steve Novella’s also discussed it), and this particular idea is definitely worth expanding upon because (1) it’s interesting and (2) it combines two of my interests, alternative medicine and evolution. I agree with parts of the idea, but it’s not without its shortcomings. Indeed, I’d very much welcome any of the evolutionary biologists who read this blog to chime in with their own ideas.

A colleague of mine, Martin Rundkvist over at Aardvarchaeology, has proposed a rather fascinating idea regarding the evolution of alternative medicine in which he argues that alternative medicine evolves according to certain selective pressures. As you may or may not know, evolution is not just for biology, but has been proposed as a mechanism in cultural memes, for example. Since alternative medicine is a cultural phenomenon, it is not unreasonable to look at such non-evidence-based medicine and hypothesize what might be the selective pressures that shape its popularity and evolution. After all, if we’re going to discourage the use of non-evidence-based medicine or even quackery, it’s helpful to understand it. We already know that alt-med terminology has evolved considerably into the current preferred term, “integrative medicine.” (See also the image above and my blog posts on this evolution here and here.)

Posted in: Basic Science, Evolution, Science and Medicine

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