Archive for the 'Science and Medicine' Category

Feb 14 2019

FDA Wants Better Supplement Regulation

It has been 25 years since the 1994 Dietary Supplement Health and Education Act (DSHEA), which reduced the FDA’s power to regulate supplements. Since DSHEA supplements have been regulated like food, not drugs, with no preapproval process. The FDA can only take action after a product is on the market, and they have the burden of proof of either harm or adulteration (for example, by containing actual drugs).

Unsurprisingly:

Since the law was enacted, the industry has grown from 4,000 products and $4 billion a year in sales to as many as 80,000 products and $50 billion in sales, according to the FDA.

There is no evidence that those additional 76,000 products and $46 billion per year have provided any health benefits to the public, and in fact are probably a net health negative. Anything genuinely useful, like prenatal vitamins, or supplements for actual deficiencies, were already available. The new products are mostly snake oil.

The situation is almost comically ridiculous. Herbal supplements are rampant with substitutions, contaminations, and adulterations. But even if the label is accurate, most herbs do not do what is claimed for them. They are simply not medical useful.

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Feb 12 2019

Kidney Organoid Breakthrough

We are on the cusp of several technologies that promise to transform medicine – genetic manipulation, brain-machine interface, and stem cell therapies among them. One of the hopes for stem cells is that we will be able to grow from them entire replacement organs. Imagine that you have kidney failure, and face years of dialysis with the hope of finding a kidney donor, so you can exchange that dialysis for a regimen of anti-rejection drugs. You may wait years on the list because we simply don’t have enough organs to go around.

Now imagine that even before your kidneys completely fail doctor take a skin or mucous membrane sample from you, and then over the next few month they grow a new kidney from your own cells. The kidney is your own tissue, and so there is no rejection at all. Eventually the new kidney is surgically implanted and you are good to go.

It doesn’t take much imagination to see how awesome this could be. If we could grow new hearts, lungs, livers, pancreases or kidneys from one’s own tissue that would transform medicine. The threshold for doing transplants could go way down, because we no longer need donors, we can grow them. The risk would go down because there is no longer the possibility of rejection and therefore the need for powerful anti-rejection drugs, so we could do transplants in more situations. We wouldn’t have to wait for organs to completely fail. Also, if you have cancer we don’t have to try to preserve as much of the organ as possible – just take the whole thing out, making sure you get all the cancer, and replace it with a new one.

This would be a truly transformative medical advance that would bring us into a new age of medicine. I don’t think we are close (meaning <10 years) to such applications, but we are close enough to say that researchers are working on it, and to see a path to get there. It’s enticing.

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Feb 08 2019

Oral Insulin

Insulin is a protein. Like all protein (or peptide) drugs it needs to be injected, you can’t take it in pill form. This is because proteins are digested in the GI tract, are generally large and difficult to absorb intact, and if they make it that far they then have to deal with the liver before they can get to their intended target. So protein or peptide drugs are simply not able to be delivered orally.

The need to give daily injections is literally a pain, however. There has therefore been extensive research in the pharmaceutical industry into methods to allow for oral, transdermal, or mucous membrane administration of so-called biologicals. As this review states:

These problems can be overcome by adopting techniques such as chemical transformation of protein structures, enzyme inhibitors, mucoadhesive polymers and permeation enhancers.

A new study which is getting some media attention takes a completely different approach – they have created an autoinjector that you swallow, which then injects insulin into the stomach from the inside. The research is the result of collaboration between academics and industry:

Giovanni Traverso, an assistant professor at Brigham and Women’s Hospital, Harvard Medical School, and a visiting scientist in MIT’s Department of Mechanical Engineering, where he is starting as a faculty member in 2019, is also a senior author of the study. The first author of the paper, which appears in the Feb. 7 issue of Science, is MIT graduate student Alex Abramson. The research team also includes scientists from the pharmaceutical company Novo Nordisk.

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Jan 10 2019

Children and Screen Time

Most parents worry about how much time their children are spending in front of computer screens, smartphones, and other electronic devices. This is a reasonable worry – this is a fairly dramatic cultural change, and the experience is different than what most of today’s parents experienced when they were children.

Pediatricians have also been warning about excessive screen time, which has been linked to obesity. But current research and recommendations are getting more nuanced, and pediatric organizations have recently walked back or altered their recommendations.
A recent review published in the BMJ found:

We found moderately strong evidence for associations between screentime and greater obesity/adiposity and higher depressive symptoms; moderate evidence for an association between screentime and higher energy intake, less healthy diet quality and poorer quality of life. There was weak evidence for associations of screentime with behaviour problems, anxiety, hyperactivity and inattention, poorer self-esteem, poorer well-being and poorer psychosocial health, metabolic syndrome, poorer cardiorespiratory fitness, poorer cognitive development and lower educational attainments and poor sleep outcomes. There was no or insufficient evidence for an association of screentime with eating disorders or suicidal ideation, individual cardiovascular risk factors, asthma prevalence or pain. Evidence for threshold effects was weak. We found weak evidence that small amounts of daily screen use is not harmful and may have some benefits.

The evidence is weak, and correlational only. This means we cannot conclude that screen time causes obesity, anxiety, or other issues. It may be, for example, that children who are sedentary for other reasons are both overweight and engage in sedentary activities, many of which involve screen time.
Based on this review, The Royal College of Paediatrics and Child Health said that there is insufficient evidence to conclude that screen time in itself is “toxic.”

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Jan 07 2019

Crowdfunding Quackery

A recent study in The Lancet highlights a disturbing trend – cancer patients using crowdfunding sites to pay for worthless and misleading fake cancer treatments, like homeopathy. They found that in June of 2018 there were 220 active GoFundMe campaigns for “alternative” treatments for cancer.

In this study, which focused specifically on homeopathy (which is 100% complete snake oil), 38% were seeking to use homeopathy in addition to conventional treatment, 29% instead of conventional treatment, and 31% after conventional treatment had failed. The authors, Snyder and Caulfield, were appropriately concerned about these trends.

At this point the most common question to ask is, “What’s the harm.” Well, it is extensive and severe – let me elaborate. In 2017 a study looked at cancer patients, their use of alternative treatments, and their survival. They found that overall if you used alternative treatments you were 2.5 times as likely to die during the study. For the most treatable cancers, like breast cancer, the risk of death was almost six times higher. That is a massive increased death rate. This increased risk of death was controlled for how sick the patients were. The most likely contributor to the increased death rate was delay in conventional treatment.

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Dec 10 2018

To Screen Or Not To Screen

Should you regularly see a physician for preventive medicine and to screen to potential health problems? Of course, and this has been consistent messaging to the public for decades. However, specific decisions about whether or not to perform a specific screening test can be complicated, and this muddies the messaging.

The problem is that there is a disconnect between how optimal medical decisions are made, and how individuals approach their own medical care (or that of their loved-ones). Optimal medical decision-making, which results in the best possible outcomes, are based on careful analysis of the best evidence available. Specifically, it considers risk vs benefit – what is the net effect of doing, or not doing, any medical intervention compared to the alternatives? This is necessarily a statistical determination, because we cannot literally see the future.

But people don’t like making cold, hard statistical decisions, especially about something as personal and important as health care. They prefer to prioritize hope. Also, people tend to be risk-averse, but also wish to avoid missing out on a potential benefit. Therefore, psychologically we will tend to go for the option that offers the most hope, not the option that has the statistical best outcome. This is part of the role of the physician – to advise their patients with the hard analysis.

All this is just considering individual decisions, but increasingly we are making societal decisions. These often include cost-effectiveness. This is because we are resource-limited, and decisions about what health care to provide and how to provide it has a dramatic impact on, again, statistical outcomes. If you are on the board of health of a state deciding how to spend your Medicare dollars, then you have to decide, for example, to pay for one liver transplant to save one life, or more basic medical care that might save hundreds of lives for the same money.

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Nov 15 2018

Spain Seeks to Ban Alternative Medicine

It’s nice to get the occasional good news, to know that there are other people out there who respect facts and science. The Spanish government announced that it plans to ban alternative medicine from state health centers. This is a bold move, and completely justified. In fact, any other approach is nothing short of outrageous.

In Spain there is a robust state health system, which covers all people living and working in Spain – about 90% of the population use public health care. About 19% use private health care to some extent. Spain is considered to have one of the best health care systems in the world, and has the life expectancy to go with it.

Now they want to make their health care system even better by purging it of harmful and wasteful pseudoscience. They have not yet provided a comprehensive list of what they consider “alternative” but gave homeopathy and acupuncture as examples (a good place to start). The Guardian reports:

The proposal, unveiled by the science and health ministers, aims to avoid the “potential harmful effects” of the practices when they are used as an alternative or a complement to treatment that is itself based on “proof and scientific rigour”, the government said in a statement.

At its core it is a simple and even obvious standard – provide health care that the best available scientific evidence says is safe and effective, and is the best option available, provided by licensed professionals. I have yet to hear even a semi-reasonable argument against this basic approach. The “alternative” is to use treatments that are not safe, not effective, or have been inadequately tested, provided by those who are not legitimate experts or professionals.

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Nov 08 2018

Echinacea Does Not Work for the Cold

We are heading into cold and flu season, so Time magazine decided to helpfully tell us what the science says about echinacea and the common cold. Unfortunately, they completely bungled their report, getting the bottom line wrong. Exactly where they go wrong, however, is extremely common and instructive.

The terrible article is partly not the fault of the author. They spoke to experts and tried to do a balanced piece. Unfortunately, there are experts out there who are biased and just wrong. The author was not able to make sense of the evidence themselves, and so they helplessly just passed along whatever nonsense they were told. This is another manifestation of the infiltration of “alternative” medicine into our system – there are always going to be “experts” out there who are just alternative cranks, but they will get quoted along side more serious scientists.

For example, they write:

Other experts say there is evidence that echinacea can be helpful. “Echinacea is popular because it does work for at least some people,” says Kelly Kindscher, a professor of environmental studies at the University of Kansas who has written a textbook on echinacea. While some clinical trials have not shown echinacea to be effective, Kindscher says others have found benefits.

I understand listening to someone who wrote a textbook on the topic, but this conclusion flies in the face of published reviews. The next statement shows where they go wrong:

A 2010 study published in the Annals of Internal Medicine compared echinacea to a placebo and to no treatment at all. It found evidence that echinacea outperformed both when it came to reducing the duration of the common cold — but these benefits were too small to be considered statistically significant.

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Oct 30 2018

Anti-Vaxxers on the Rise

A new report looking at vaccine confidence in the EU shows some troubling trends. Belief in the safety and effectiveness of vaccines seems to be very regional. We see this in the US as well as Europe. In this survey they found:

The results of the survey suggest that a number of member states – including France, Greece, Italy, and Slovenia – have become more confident in the safety of vaccines since 2015; while Czech Republic, Finland, Poland, and Sweden have become less confident over the same period.

In some countries anti-vaxxers have a stronger foothold, and are actually decreasing acceptance of vaccines. But there are two other trends that are more disturbing. First, in the countries with decreasing vaccine acceptance there is high levels of vaccine skepticism among general practitioners.

While GPs generally hold higher levels of vaccine confidence than the public, the survey found that 36% of GPs surveyed in Czech Republic and 25% in Slovakia do not agree that the MMR vaccine is safe and 29% and 19% (respectively) do not believe it is important.

Those are shockingly high numbers for physicians. This is one of my greatest fears about the advance of alternative medicine and anti-scientific medical views – that they will affect the medical profession itself. Once unscientific ideas creep into the culture of medicine, the game is all but lost. This is why teaching pseudoscience in medical school is such an alarming problem. In this survey, the countries with higher levels of GP vaccine skepticism, had higher levels of public skepticism and lower levels of vaccine compliance.

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Oct 29 2018

Study Questions Glasses for Colorblindness

I am what is known as a mild protan. That means that the cones of my retina that perceive red and green wavelengths are not as separated in their frequency response as they should be. This overlap causes some shades of red and green to look similar. As far as I am aware, the only deficit this has caused in my life is the inability to see some of those numbers in the circles of colored dots used to test color vision. Although some color combinations, such as the orange and green of the Miami Dolphins jerseys, are uncomfortable to look at.

But other people have more severe forms of color blindness that can actually affect their lives, such as the ability to distinguish red and green traffic lights.

I was therefore intrigued on a personal as well as scientific level when I first heard the claims for glasses that can compensate for some forms of color blindness. To me the claims sounded only semiplausible. The problem with partial color-blindness is in the cones – the retinal cells that perceive color – so how could you correct this by simply filtering the frequency of light? But I left open the possibility that by specifically altering some colors you could enhance their separation, making them easier to distinguish.

I never had the opportunity to test the glasses (they are expensive) but fortunately there is now an independent study of their effectiveness. Specifically researchers at the University of Granada tested the EnChroma® glasses.  As the researchers note, the company that makes the EnChroma glasses has been watering down their claims in the typical way that supplement manufacturers often do, which for me is a huge red flag. They now state on their website:

“EnChroma glasses are an optical assistive device for enhancement of color discrimination in persons with color blindness; they are not a cure for color blindness. Results vary depending on the type and extent of color vision deficiency per individual.”

Sounds an awful lot like the “structure function” claims of supplements, which cannot claim to treat or cure any disease. I could not find more specific claims made by the manufacturer on their website. They also say things like:

“EnChroma color blindness glasses can have a profound impact on how people see their world.”

Yeah – so do sunglasses. This is a clever implied claim here, without actually making a specific claim. They also present reviews on their site, quoting other people who make more profound claims. This is the common “testimonials” approach – let other people make the claims so you don’t have to.

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