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Archive for November, 2013

You be the judge

Jann Bellamy recently recapped her experience attending a meeting sponsored by her local Healing Arts Alliance. As you re-read her article pay particular attention to the language used by the Alliance to describe themselves and the treatments they offer. For me, there is one word that really stands out. It is emblematic of the attitude of the complementary and alternative medicine community. A word meant to represent a virtue is really a self-serving recusal of critical-thinking. Not wanting to misinterpret their intent, I went the website of the Healing Arts Alliance to get the full context. Here is the mission statement, in full, pasted from their website: (more…)

Posted in: Science and Medicine

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Happy Thanksgiving!

We celebrate Thanksgiving Day in the U.S. on the fourth Thursday in November. Because I live in the U.S. and Thanksgiving falls on my regular blogging day this year, I get the day off.

On this Thanksgiving Day, I am thankful for the cornucopia of blog fodder coming up as we move toward the end of 2013 and into 2014. The Bravewell Collaborative is shutting down this month although it is not giving up on pushing the integrative medicine agenda. On December 13th, the Council for Chiropractic Education, which is only provisionally accredited now due to failure to follow numerous regulatory requirements, will have its day in court before the National Committee on Institutional Quality and Integrity. The NAICI will then recommend to the Department of Education whether or not the CCE should continue as the approved accrediting agency for all chiropractic colleges. On January 1, 2014, Section 2607 of the Affordable Care Act, which prohibits discrimination against state-licensed CAM providers, kicks in along with the rest of the ACA. Lawsuits to follow. Early next year will undoubtedly bring a new batch of proposed state legislation seeking to license naturopaths as primary care doctors. These are always interesting reading as they inevitably include a laundry list of legally permissible quacky naturopathic treatments such as colonic irrigation, organ repositioning and homeopathy. And, given the ACA’s emphasis on, and reimbursement for, primary care, chiropractors will certainly continue their campaign to convince everyone that they are actually PCPs. I expect legislation will be introduced seeking expansion of chiropractic and naturopathic scope of practice. Perhaps acupuncture too.

So stay tuned. And Happy Thanksgiving wherever you live.

Posted in: Announcements

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The FDA and Personalized Genetic Testing

The company 23andMe provides personal genetic testing from a convenient home saliva sample kit. Their home page indicates that their $99 genetic screening will provide reports on 240+ health conditions in addition to giving you information on your genetic lineage. The benefits, they claim, are that you will learn about your carrier status and therefore the risk of passing on genetic diseases to your children. The information will also inform you about health risks so that you can change your behavior to manage them. Finally the genetic information will tell you about how you might respond to different drugs so that you can “arm your doctor with information.”

The home page also contains a link to testimonials about how their DNA testing has changed people’s lives.

This all sounds great – the promise of genomics that we have been hearing about now for about two decades. Isn’t this exactly what we were led to expect once we mapped the human genome?

Why, then, has the FDA recently sent a warning letter to 23andMe instructing them to discontinue marketing their Personal Genome Service (PGS)?

The primary reason appears to be a lack of documentation for the validity and reliability of the tests, but I have concerns that go even deeper. (more…)

Posted in: Public Health

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New Cholesterol Guidelines

On November 15, the American College of Cardiology and the American Heart Association released an updated guideline for the use of statins to prevent and treat atherosclerotic cardiovascular disease (ASCVD). The full report is available online. It has already generated a lot of controversy. The news media have characterized it as a “huge departure” from previous practice and have trumpeted that it will lead doctors to prescribe statins to millions more people. As usual, the truth is much more nuanced. There are some problems with the guidelines, but on the whole they represent an improved, more rational approach to prescribing statins.

Statins have always been a source of controversy: people seem to either love them or hate them, and discussions about them generate a lot of emotion. The International Network of Cholesterol Skeptics denies that cholesterol has anything to do with cardiovascular disease. An article on HuffPo calls statins “an unsafe, unnecessary product that will now be recommended to healthy people to make them sicker.” Mercola says they can actually make heart disease worse and cause premature aging, and no one should take them unless they have the genetic defect of familial hypercholesterolemia. A website collects patient self-reports of adverse effects; but like the vaccine reports on VAERS, these are only anecdotal reports of correlation, not evidence for causation.

At one time the evidence only supported using statins for secondary prevention and for men. We now have better evidence showing that they are effective for both primary and secondary prevention in patients of both sexes and all ages, and that they are more effective for those with higher risk factors. (more…)

Posted in: Pharmaceuticals

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“Low T”: The triumph of marketing over science

A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel…for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.

The Colbert Report, December 2012

 

And now for something completely different…sort of.

After writing so much about the latest developments in the ongoing saga of the cancer doctor who is not an oncologist and not a legitimate cancer researcher, plus a rumination on what’s up with President Obama’s nominee for Surgeon General and our favorite form of unscientific medicine, so-called complementary and alternative medicine (CAM), also known as “integrative medicine,” I thought it was time for a change of pace. I wasn’t sure what I was going to write about as Sunday rolled around, but fortunately, as sometimes happens, the New York Times dropped a topic right in my lap, so to speak, both figuratively and literally. It comes in the form of a long article on something that directly concerns men of a certain age, which unfortunately happens to mean men of my age and older. I’m referring to what pharmaceutical company advertising campaigns have dubbed “low T,” short for low testosterone. It’s not clear how the term “low T” originated but Dr. Abraham Morgentaler, founder of Men’s Health Boston, claims to have coined the term when his patients were embarrassed by their difficulty pronouncing the word “testosterone.” Other sources report that it was Solvay Pharmaceuticals that coined the phrase. It doesn’t really matter where the term “low T” came from. The term has stuck, even though the more “correct” medical term would be hypogonadism, as in a man’s testes not working.
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Posted in: Clinical Trials, Diagnostic tests & procedures, Pharmaceuticals, Science and the Media

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A Rational Approach to Managing Acute Pain in Children

Pain is one of the most common reasons for a parent or caregiver to seek medical attention for their child. Children experience pain for a wide variety of reasons, many that are similar to if not exactly the same as causes of adult pain, but historically pediatric patients have been grossly undertreated. I am 37-years-old and, sadly, if I had undergone a surgical procedure as an infant there would have been a significant chance that I would have received no analgesia at all. Things are better now, but there remains a large gap between what is recommended and how pediatric pain management is practiced in the real world.

The appropriate management of a child’s pain is a vital aspect of compassionate and high quality care, and it is simply the right thing to do. Failing to treat pain effectively is ethically no different than purposefully causing pain in a child, and it can have serious repercussions. Poorly controlled pain can interfere with a child’s recovery because of the negative impact of catecholamine surges and other stress-related chemicals, and impair the ability to take part in physical or occupational therapy. It can also make future encounters with health care professionals more challenging because of anxiety and mistrust.

Untreated pain can interfere with deep breathing, potentially leading to prolonged need for supplemental oxygen and increased risk of pneumonia. It can prevent restful sleep, which has myriad health consequences beyond just cognitive impairment. Pain can interfere with the family unit by significantly increasing parental or caregiver anxiety, which can lead to neglect, abuse, and increased utilization of healthcare resources. Poorly-managed acute pain can increase the likelihood of a patient, even a child, developing chronic pain. There is even good evidence in neonates (my next post I think), that poorly managed acute pain can lead to increased sensitivity and an increased pain response to future occurrences of procedural pain, such as routine immunizations.

Multiple reports throughout the 1970′s and 1980′s revealed that pediatric patients received substantially less pain treatment compared to adults for equivalent conditions, such as broken bones and hernia repair. Despite steady improvement in pain management in kids over the past few decades, we still have a long way to go. Though appropriate anesthesia is now standard of care in children of all ages, many physicians are uncomfortable with evaluating and treating acute pain (chronic pain is another topic) in children. And many parents are resistant to the use of safe and effective pain medications.

Even with physicians that might profess their comfort with recognizing and treating pediatric pain, my admittedly personal experience is that many still allow kids to be in pain at times for a variety of reasons. However, it isn’t that these physicians and caregivers are heartless or enjoy watching their patients, or their children if it is a parent putting up a roadblock, suffer. Even knowing a child is in pain can sometimes be challenging. And there are many misconceptions regarding pain in children that interfere with appropriate treatment. The bulk of these misconceptions involve the use of opioids. All of these misconceptions and false beliefs should be amenable to education and increased awareness of science-based guidelines.

Pediatric pain is a challenging entity. So much so that many institutions have pediatric pain teams. My wife is an expert on pediatric pain and spends her days, and often nights, as a palliative care pediatrician helping to manage pain and other symptoms in children who are approaching the end of life. Her insights and expertise on this topic have been invaluable in my own encounters with pain as a pediatric hospitalist. Her experience, like mine, is that even at major academic institutions pain management is regularly not approached systematically, nor based on the best available evidence.

So what is pain exactly, and how is it assessed in kids?
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Posted in: Science and Medicine

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Do vitamins prevent cancer and heart disease?

It is a triumph of marketing over evidence that millions take supplements every day. There is no question we need vitamins in our diet to live. But do we need vitamin supplements? It’s not so clear. There is evidence that our diets, even in developed countries, can be deficient in some micronutrients. But there’s also a lack of evidence to demonstrate that routine supplementation is beneficial. And there’s no convincing evidence that supplementing vitamins in the absence of deficiency is beneficial. Studies of supplements suggest that most vitamins are useless at best and harmful at worst. Yet the sales of vitamins seem completely immune to negative publicity. One negative clinical trial can kill a drug, but vitamins retain an aura of wellness, even as the evidence accumulates that they may not offer any meaningful health benefits. So why do so many buy supplements? As I’ve said before, vitamins are magic. Or more accurately, we believe this to be the case.

There can be many reasons for taking vitamins but one of the most popular I hear is “insurance” which is effectively primary prevention – taking a supplement in the absence of a confirmed deficiency or medical need with the belief we’re better off for taking it. A survey backs this up – 48% reported “to improve overall health” as the primary reason for taking vitamins. Yes, there is some vitamin and supplement use that is appropriate and science-based: Vitamin D deficiencies can occur, particularly in northern climates. Folic acid supplements during pregnancy can reduce the risk of neural tube defects. Vitamin B12 supplementation is often justified in the elderly. But what about in the absence of any clear medical need? (more…)

Posted in: Herbs & Supplements, Nutrition, Science and Medicine

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The new Surgeon General nominee and CAM: Is there a problem here?

Our fearless leader, Steve Novella, has informed me that he is traveling today. Unfortunately, I am preparing a talk for later today, and no one else seemed able to come up with a post; so I decided to adapt a recent post from my not-so-super-secret other blog and see what a different readership thought of it. I realize that I’m risking subjecting you all to Gorski overload, but, hey, if the world needs more Mark Crislip, why wouldn’t the world need more David Gorski too? Steve will return next Wednesday, as usual.

I don’t normally give a lot of thought to the Surgeon General because, quite frankly, in recent years it hasn’t been a position of much authority or influence. That’s why I didn’t noticed late last week that President Obama had nominated a new Surgeon General. Normally, my failure to notice isn’t such a big deal, because there really hasn’t been a Surgeon General who has really been particularly well-known or had much of an impact since Dr. C. Everett Koop, although back when President Obama first took office Dr. Sanjay Gupta’s name was floated as a possibility for the position. Obviously, he didn’t get it. (I’m guessing that being a neurosurgeon and CNN’s chief medical correspondent probably pays much better than being Surgeon General.) To be honest, I didn’t even know that the prior Surgeon General had stepped down, but apparently she did in July, leaving the position filled by an interim Surgeon General until a new one could be nominated.

The other day, I learned whom President Obama nominated to be her successor, Dr. Vivek Murthy, a faculty member at the Harvard Medical School:

President Obama will nominate Dr. Vivek Murthy of Harvard Medical School and Brigham and Women’s Hospital as surgeon general of the United States, the White House announced Thursday night.

Murthy is a hospitalist at the Brigham and is co-founder and president of Doctors for America, a Washington, D.C.-based group of 16,000 physicians and medical students that advocates for access to affordable, high quality health care and has been a strong supporter of the Affordable Care Act.

If he’s confirmed by the Senate, Murthy would replace acting surgeon general Boris Lushniak. The surgeon general serves a four-year term and the post is essentially a bully pulpit to speak out on public health issues.

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Posted in: Acupuncture, Politics and Regulation, Public Health, Science and the Media

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Faith Healing: Religious Freedom vs. Child Protection

We have written a lot about people who reject science-based medicine and turn to complementary/alternative medicine (CAM), but what about people who reject the very idea of medical treatment?

Faith healing is widely practiced by Christian Scientists, Pentecostalists, the Church of the First Born, the Followers of Christ, and myriad smaller sects. Many of these believers reject all medical treatment in favor of prayer, anointing with oils, and sometimes exorcisms. Some even deny the reality of illness. When they reject medical treatment for their children, they may be guilty of negligence and homicide. Until recently, religious shield laws have protected them from prosecution; but the laws are changing, as are public attitudes. Freedom of religion has come into conflict with the duty of society to protect children. The right to believe does not extend to the right to endanger the lives of children. A new book by Cameron Stauth, In the Name of God: The True Story of the Fight to Save Children from Faith-Healing Homicide, provides the chilling details of the struggle. He is a master storyteller; the book grabs the reader’s attention like a fictional thriller and is hard to put down. He is sympathetic to both the perpetrators and the prosecutors of religion-motivated child abuse, and he makes their personalities and their struggles come alive. (more…)

Posted in: Book & movie reviews, Faith Healing & Spirituality, Politics and Regulation

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The Burzynski Empire strikes back

You might have noticed that I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly-unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction of bad science and bad medicine in a large mainstream news outlet like USA TODAY is rare and gratifying. As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners. Most of this, of course, is no news to SBM readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over two years now. It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog. Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1:

As far as clinical trials go, it was a joke…it was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

And Jaffe’s characterization of the six dozen phase II clinical trials that Burzynski submitted in the late 1990s was this:

A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

I’m just repeating those quotes again, because they can’t be emphasized enough. Quite frankly, if I were Burzynski, I’d fire Jaffe for having published such statements in his book. But that’s just me. In the meantime, let’s take a look at the counterattack and why Burzynski’s excuses regarding the deficiencies found in the FDA reports do not ring true.
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Posted in: Cancer, Clinical Trials, Science and the Media

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