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FDA approval of Alzheimer’s disease drug aducanumab – Inspector General may investigate

Alzheimer's disease drug

Last week, the US Food and Drug Administration (FDA) approved the first new drug, Aduhelm (aducanumab), for Alzheimer’s disease in 18 years. The new drug is manufactured by Biogen, a US-based pharmaceutical company, and if you read the news reports and social media posts, you’d think the new drug is a miracle.

Given that Alzheimer’s disease afflicts over six million Americans each year, we wanted to celebrate aducanumab as a miracle. Except, there’s really nothing to celebrate here.

The FDA ignored the advice of its own expert advisory committee, which voted overwhelmingly (eight against approval, one for, and two abstained) to not recommend the drug because, according to the FDA’s own analyses, the drug failed to show that it can do anything to treat Alzheimer’s devastating cognitive decline. Plus aducanumab costs $56,000 per year (yes, $56,000) and comes with a relatively high risk for brain swelling and bleeding.

In response to the outcry, Acting FDA Commissioner Janet Woodcock wrote a letter to the acting inspector general of the Department of Health and Human Services, acknowledging that there has been “significant attention and controversy” surrounding the approval of Aduhelm. In particular, Woodcock said, concerns continue to be raised about the agency’s contacts with Biogen, including “some that may have occurred outside of the formal correspondence process.”

So we have to ask why would the FDA approve this new drug for Alzheimer’s disease, even though aducanumab is expensive, has serious side effects, and probably doesn’t do anything to improve the outcomes of Alzheimer’s patients? And because the drug is so expensive and everyone will demand the drug for the disease, this could add hundreds of billions of dollars to the cost of healthcare in the USA and across the world (don’t believe for a second that this possibly worthless drug is going to cost only $5.00 in Denmark, because it won’t).

The answers to these questions are complicated, and I’ll try to explain. But I think what happened here is disturbing and tragic. And it could have implications for any new drug approved by the FDA.

Continue reading “FDA approval of Alzheimer’s disease drug aducanumab – Inspector General may investigate”
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Canola oil causes Alzheimer’s disease? Dubious evidence

Canola oil causes Alzheimer's disease

Food fads make me want to scream, cry, and hide in a cabin in the mountains. MSG is safe. And high fructose corn syrup is just an awful name for sugar. And only a small number of people have a real gluten sensitivity. And now a published article has caused the internet to explode with the trope that canola oil causes Alzheimer’s disease.

This new internet meme is based on a peer-reviewed article published in a real journal. But as I have written time and again, just because an article seems like it has sterling credentials, it doesn’t mean the article is above criticism. We’ll get to this article below.

As expected, all of the usual suspects in the pseudoscience world have jumped on board with clickbait headlines like, “Scientists finally issue warning against canola oil: Study reveals it is detrimental to brain health, contributes to dementia, causes weight gain.” I always find it ironic when a pseudoscience-pushing website believes in scientists when it supports their belief.

Of course, we need to take a look at this whole issue. Here’s my spoiler alert (but please read the whole article) – there is little evidence that canola oil causes Alzheimer’s disease (AD) or dementia. You can use it safely. Continue reading “Canola oil causes Alzheimer’s disease? Dubious evidence”

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Zombie pig brains – once again, internet exaggerate scientific results

I’m sure many of you read the news – scientists somehow made pig brains come back to life a few hours after the pigs died. Of course, most news sites had to produced clickbait headlines, and since most people don’t read beyond those headlines, there is a whole new mythos about these zombie pig brains. 

We’re here to correct some of that information. Hopefully, a few people will look beyond the headline to examine the science rather than fall for pseudoscientific dreck. Continue reading “Zombie pig brains – once again, internet exaggerate scientific results”

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Measles causes SSPE – child pays price for anti-vaccine misinformation

On 7 March 2015, a four-year-old Italian girl dubbed “Clara” by the media (real name hidden to protect her privacy) died from subacute sclerosing panencephalitis (SSPE), a complication of measles, after prolonged suffering (the girl was in the hospital in which she died for over 4 months, and has been sick at least since last October, and hospitalized elsewhere). Continue reading “Measles causes SSPE – child pays price for anti-vaccine misinformation”

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Marijuana medical benefits – large review finds very few

Marijuana medical benefits

Most states in the USA, and many countries across the world have passed legislation that allows the use of marijuana for medical purposes. Some of this legislation is dependent on various claims, many of which appear to be based on weak or nonexistent scientific evidence. Of all of the purported marijuana medical benefits, only a handful are supported by real evidence.

This review, Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda (pdf, which can be downloaded for free by registering or can be found online here), published by the influential and prestigious National Academies of Science, Engineering, and Medicine, examined more than ten thousand scientific studies that involved cannabis and various medical conditions. The value of such a review is that it examines not only the quantity of evidence supporting a claim but also the quality of such evidence. In the end, it gives much more weight to high-quality evidence.

I know many comments will drop on this article that “you haven’t read that incredible study published in Journal of Weed and Cancer Cures” – that misses the point. The National Academies is a highly respected institution, made up of the most respected scientists in the USA. And the committee that created this review is made up of leading public health, cancer, epidemiology, pharmacology, and psychiatry, all fields germane to understanding clinical and basic scientific research into cannabis.

Moreover, a review like this does two things – it gives more weight to well done clinical trials and pre-clinical studies, and it eliminates poorly done and biased studies. This is how science works – examine ALL of the evidence before coming to a conclusion. Pseudoscience, on the other hand, is to have a conclusion, like “weed cures cancer,” and only seeking evidence that supports that preordained conclusion.

Furthermore, and this cannot be stressed enough, this review is not opinion. It is not belief. It is not cherry picking. It is a critical analysis based on thousands of studies published in peer-reviewed journals. This is not published in a pro-cannabis website that cherry picks, misinterprets, and overrates a one-off study in an obscure journal. The report is over 400 pages long – most of you will not read even a few pages, because it is a dense scientific review written by some of the top scientists in the USA. Before you denigrate the study, I would suggest you read it carefully.

To save you time from reading the 400+ page opus, which I did, I divided up the medical evidence from strong to none of the evidence in support of benefits and of risks from smoking cannabis. Not to bury the lede, but there are only three conditions for which there is strong, overwhelming evidence benefits of marijuana. Just three. Continue reading “Marijuana medical benefits – large review finds very few”

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HPV vaccine and multiple sclerosis – 2 million doses show no link

hpv vaccine and multiple sclerosis

We keep reading false claims about Gardasil, like some link between the HPV vaccine and multiple sclerosis. It is important that we, those who support vaccines, keep focusing on the huge studies that support the facts about the safety of the vaccine.

Despite the established effectiveness of the HPV vaccine in preventing the HPV infection and subsequent HPV-related cancers, the internet rumors about the dangers of the vaccine sometimes feel like it wins the day.

Remember, despite what you read on pseudoscience website or from anecdotes on the internet, there are really only a few ways to prevent cancer. Don’t smoke. Don’t drink alcohol. Stay out of the sun. Keep a very healthy (read low) weight. And get your HPV (and hepatitis B) vaccines.

This post is going to discuss a seminal article about the safety of vaccines – an epidemiological study of over 2 million young women to determine the incidence of neurological disorders in HPV-vaccinated vs. unvaccinated groups. This powerful study tells us one thing – that the continued claims about Gardasil causing all these weird neurological issues is not supported by unbiased, scientifically analyzed, peer-reviewed articles. And head’s up, there appears to be no evidence supporting a link between the HPV vaccine and multiple sclerosis.

Let’s discuss.

Continue reading “HPV vaccine and multiple sclerosis – 2 million doses show no link”

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Vaccines cause multiple sclerosis? No link found in a large scientific review

Vaccines cause multiple sclerosis

There are so many anti-vaccine religious tropes about the safety of vaccines, that it is often hard to keep them all straight. One of the current ones is that vaccines cause autoimmune diseases such as multiple sclerosis. Does scientific evidence support the hypothesis that vaccines cause multiple sclerosis?

Well, I have written about whether vaccines cause multiple sclerosis before, and based on the scientific evidence (see here and here), there simply was no link between them. Of course, with the anti-vaccine religion, evidence be damned, they will stand by their claims. All I can do is repeat myself with more and more evidence, refuting their claims.

There is a new review of the evidence of whether vaccines cause multiple sclerosis, and once again, they found nothing. And once again, I will review the evidence to see if there is something to the claims of the anti-vaccine religion. I should give a spoiler alert, but you all know what’s coming. Continue reading “Vaccines cause multiple sclerosis? No link found in a large scientific review”

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LeRoy neurological disorders – PANDAS, vaccines, and whatever?

leroy neurological disorders

In spring 2012, I had written a few articles about a mystery neurological ailment that had struck about 20 teenagers at a high school and surrounding area in LeRoy, NY, a small town about 30 minutes from the city of Rochester. They suffered tics that mimicked Tourette syndrome, but was never diagnosed as such. Most of them have recovered, although two new cases have appeared. It’s been five years, so let’s update the news about the LeRoy neurological disorders.

I first wrote this article in 2013, yet it continues to be one of the top read articles on this blog. I’m not sure why, it may be because the outbreak was blamed on many factors that cross paths with internet conspiracies about health. Like vaccines.

Since this article about the LeRoy neurological disorders is so popular, I decided to update it (and clean up the huge number of broken links). I have also looked at the recent news about “outbreak,” and I will post links to some of the more intriguing hypotheses here.

Entering the Way-back Machine, let’s see what has happened in the past, just to catch everyone up. Continue reading “LeRoy neurological disorders – PANDAS, vaccines, and whatever?”

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Marijuana treatment of PTSD and chronic pain – probably does not work

marijuana treatment

I’ve written extensively about marijuana treatment for various diseases. For example, using it to prevent or treat cancer? No clinical evidence support its use. In fact, a large review of published science on medical marijuana showed little evidence of it having a clinical benefit except for just a few conditions, one of which was chronic pain.

Apparently, there is little scientific evidence to draw conclusions about the benefits and harms of marijuana treatment for patients with posttraumatic stress disorder (PTSD) and chronic pain, according to two studies published recently in the respected journal Annals of Internal Medicine.

Let’s take a look at these two articles and determine what they say about marijuana treatment of PTSD and chronic pain. Continue reading “Marijuana treatment of PTSD and chronic pain – probably does not work”

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Polio-like illness emerging in California – not vaccine related

polio-like illness

Polio is a crippling and potentially deadly infectious disease caused by the poliovirus, a human enterovirus, that spreads from person to person invading the brain and spinal cord and causing paralysis. Because polio has no cure, the polio vaccine is the best way to protect yourself and the only way to stop the disease from spreading. In a case study that will be presented at the 2014 American Academy of Neurology meeting, researchers report the discovery of a polio-like illness that has been found in a cluster of children from California over a one-year period.

This outbreak isn’t a result of anyone’s refusal to be vaccinated against polio, since all of the children in this study had been previously vaccinated against the poliovirus.

The United States last experienced a polio epidemic in the 1950s, prior to the introduction of the polio vaccine 60 years ago. Today, polio has been eradicated from most of the planet, as the number of worldwide polio cases has fallen from an estimated 350,000 in 1988 to fewer than 223 in 2012—a decline of more than 99% in reported cases.
Continue reading “Polio-like illness emerging in California – not vaccine related”