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Food fights in the courtroom

SBM post natural bean dip

What’s in a name? Will sugar by any other name taste as sweet? Well, yes, but calling sugar “evaporated cane juice” in an ingredient list may get food manufacturers into trouble. Consumers in several class action suits allege that companies are trying to disguise the amount of sugar in their products by calling it something else.

Robin Reese filed a class action suit against Odwalla, a subsidiary of Coca-Cola, saying use of the term “evaporated cane juice” instead of sugar fooled her into thinking she was getting a healthier product when she purchased Odwalla juice. Odwalla told the judge the suit should be dismissed because it’s up to the FDA to decide the issue. The FDA issued draft guidelines, in 2009, taking the position that the term “evaporated cane juice” should not be used because it’s not a “juice” as defined in the Federal Regulations. For unknown reasons, no final guidelines were issued and food companies seem to be honoring the draft guidance more in the breach. The FDA reopened the draft guidelines for comment in March of this year, for 3 months, but still hasn’t decided. Meanwhile, similar class actions against other companies were dismissed or stayed pending the FDA’s making up its mind. (more…)

Posted in: Health Fraud, Legal, Nutrition, Science and Medicine

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Another Lawsuit To Suppress Legitimate Criticism – This Time SBM

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I suppose it was inevitable. In fact, I’m a bit surprised it took this long. SGU Productions, the Society for Science-based medicine, and I are being sued for an article that I wrote in May of 2013 on Science-Based Medicine. My SBM piece, which was inspired by an article in the LA Times, gave this summary:

The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).

The claims and practice of Dr. Tobinick have many of the red flags of a dubious medical practice, of the sort that we discuss regularly on SBM. It seems that Dr. Tobinick does not appreciate public criticism of his claims and practice, and he wants me to remove the post from SBM. In my opinion he is using legal thuggery in an attempt to intimidate me and silence my free speech because he finds its content inconvenient.

Of course, we have no intention of removing the post as we feel it is critical to the public’s interest. This is what we do at SBM – provide an objective analysis of questionable or controversial medical claims so that consumers can make more informed decisions, and to advance the state of science in medicine.

We also feel it is critical not to cave to this type of intimidation. If we do, we might as well close up shop (which I suspect the Tobinicks of the world would find agreeable). Defending against even a frivolous lawsuit can be quite expensive, but we feel it is necessary for us to fight as hard as we can to defend our rights and the work that we do here at SBM.

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Posted in: Announcements, Legal

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Medical Malpractice Lawsuits

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We hear a lot about medical malpractice suits and how they affect the practice and the cost of medicine. Doctors sometimes get the feeling that a lawyer is looking over their shoulder as they interact with patients, and sometimes they practice “defensive medicine,” ordering unnecessary tests and doing what they think would look best in court rather than what is really in the patient’s best interests. One of my colleagues in the Air Force, a psychiatrist, said at his retirement ceremony that he considered his career a success because he had never been sued. That struck me as a sad commentary on what it means to practice medicine today.

Some of my preconceived ideas on the subject of malpractice were challenged by a recent survey. Medscape asked 3,480 U.S. physicians about their experience with malpractice suits. 60% of responding physicians reported they had never been named in a lawsuit, 31% had been sued in conjunction with other defendants like hospitals, and only 9% were sued as individuals. (more…)

Posted in: Legal

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The false hope of “right-to-try” metastasizes to Michigan

Nurse administers chemotherapy

Ed. note: Please read disclaimer in Dr. Gorski’s profile!

There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures lately known as “right to try” bills. Jann Bellamy and I have both written about them before, and with the passage of the first such bill into law in Colorado in May, I had been meaning to revisit the topic. Although “right-to-try” laws are a bad policy idea that’s not new, versions of such bills having been championed by, for example, the Abigail Alliance for at least a decade, the recent popularity of the movie Dallas Buyers Club appears to have given them a new boost, such that Colorado state Senator Irene Aguilar even frequently referred to her state’s right-to-try bill as the “Dallas Buyers Club” bill. It’s a topic I’ve been meaning to revisit since the news out of Colorado, but apparently I needed a nudge, given that it’s two months later now.

Unfortunately, that nudge came in the form of a right-to-try bill (Senate Bill 991) being introduced into the legislature in Michigan by Senator John Pappageorge and unanimously passing, almost without comment by the committee and certainly with minimal news coverage, through the first hurdle, the Michigan Senate Health Policy Committee. In parallel, the same legislation (House Bill 5651) has been introduced into the Michigan House of Representatives.
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Posted in: Cancer, Pharmaceuticals, Politics and Regulation

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Lemons and Lyme: Bogus tests and dangerous treatments of the Lyme-literati

Tick

It’s that time of year when every day I can expect to see at least one patient with a concern about Lyme disease. In Lyme-endemic regions such as Western Massachusetts, where I practice pediatrics, summer brings a steady stream of children to my office with either the classic Lyme rash (erythema chronicum migrans, or ECM), an embedded tick, a history of a tick bite, or non-specific signs or symptoms that may or may not be due to Lyme disease. Sometimes the diagnosis is relatively straightforward. A child is brought in after a parent has pulled off an engorged deer tick, and there is a classic, enlarging ECM rash at the site of the bite. More often the presentation is less clear, requiring detective work and science-based reasoning to make an informed decision and a diagnostic and therapeutic plan based on the best available evidence. Depending on the story, the plan may include immediate treatment without any testing (as in the straightforward case described above), immediate testing without treatment pending test results, or waiting as we watch and see how a rash progresses before doing anything. An example of this latter course of action would be when a patient comes in with a pink swelling at the site of a new tick bite. In this case, it may not be clear if the swelling is a Lyme rash or simply a local reaction to the bite, a much more common occurrence. The classic ECM rash (an enlarging, red, circular, bull’s-eye rash at or near a tick bite) typically develops 1-2 weeks after a tick bite, but can occur anywhere from 3-30 days later. It then expands and darkens over another 1-3 weeks before fading. This classic rash is not the most common rash of Lyme disease, however, as it occurs in only about 30% of cases. Instead, the rash may be uniformly pink or red (or even darker in the center) without the target-like appearance, or may be a linear rash, expanding outward from the tick bite site. In the case of a patient who comes in with a vague, pink swelling within a day few days of a tick bite, we will typically wait and see what happens to the rash. If it is a local reaction, it will likely resolve within another few days. With Lyme disease, the rash will continue to enlarge and declare itself as an ECM rash. Another unclear and not uncommon situation is when a patient comes in with non-specific symptoms such as fatigue, musculoskeletal pains, and headache. If warranted by the history and the physical exam, we may in this case order Lyme testing. This may not give us an answer even if the patient has Lyme disease, because results are often negative in the first few weeks of the disease. In this case, if symptoms persist or evolve, we will repeat the testing in another few weeks at which point true Lyme disease will test positive and can then be treated. The good news is that the treatment of Lyme disease, particularly in the early, localized phase of the disease, is extremely safe and effective with a 14-day course of antibiotics. The testing is also relatively straightforward, with very good sensitivity and specificity when performed correctly. And this is where the bad news comes… (more…)

Posted in: Science and Medicine

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NuVet: Pet Supplement Snake Oil

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I’m a dog person. I always wanted a dog as a child, and while my extended family all had dogs, we never had one in our home. I finally got my wish just over a decade ago. My wife and I were referred to a breeder with an excellent reputation for raising healthy, family-friendly Labrador Retrievers. Within moments of meeting a tiny black lab, we immediately put a deposit down. When we took Casey home a few months later she was healthy – a ball of kinetic energy. The breeder offered us a health guarantee – free of hip and elbow dysplasia, supported by certifications from the dog’s parents and grandparents. The breeder recommended we use a specific brand of food (which we ignored), and other than vaccinating her and promising not to breed her, there were few conditions for the guarantee. We were excited “parents” and that first year was a lot of fun.

At about 12 months of age, Casey started limping. At first we thought it was a temporary consequence of boisterous play. It was initially subtle, but then became very obvious – she started walking differently, and it didn’t go away. The x-rays confirmed what we feared: elbow dysplasia. Our breeder was deeply apologetic – consistent with the guarantee, she offered to replace our dog. Giving up our pet was out of the question, so we started looking at treatment options. The veterinarian offered surgery, but even he wasn’t enthusiastic, citing the very real likelihood it would do nothing. Knowing the toxicity of anti-inflammatory drugs, I wasn’t optimistic that would be tolerable for the long run. Instead we went the supplement route. (more…)

Posted in: Science and Medicine

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Acupuncture for Menopausal Symptoms

Acupuncture

A newly published meta-analysis of studies looking at acupuncture for symptoms resulting from natural menopause (not drug or surgically induced) by Chiu et. al. is entirely negative. That is not what the authors or the press release conclude, however.

This disconnect between the study results and the interpretation of those results is a persistent problem in medicine generally to some degree, but is endemic and profound within the CAM (complementary and alternative medicine) culture. Acupuncture in particular is promoted almost entirely based on this type of misinterpretations – the kind that can magically turn negative studies into positive studies.

In the abstract the authors conclude:

This meta-analysis confirms that acupuncture improves hot flash frequency and severity, menopause-related symptoms, and quality of life (in the vasomotor domain) in women experiencing natural menopause.

Let’s take a close look at the results, however. Indeed, when comparing acupuncture to no treatment controls there was a significant decrease in subjective symptoms in the pooled data. Outcomes were hot flash frequency, hot flash severity, other menopausal symptoms, and quality of life. Some of the included studies were large controlled trials, which the authors used to argue that their results are valid. They also point out that their results showed heterogeneity and lack of publication bias.

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Posted in: Acupuncture

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Evaluating Treatment Claims: A Primer

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I recently wrote about the claim that acupuncture can improve vision in patients with macular degeneration. In response, I received this e-mail:

At Discovery Eye Foundation we have an education and outreach program for people with age-related macular degeneration, the Macular Degeneration Partnership. We are constantly getting calls from people who have heard of a new “cure” or a way to stop their vision loss. It is always hard to interject reality into the conversation and hear the hope leave their voice, replaced by frustration or despair.

The e-mail suggested I write an article providing guidelines for consumers to help them evaluate the validity of treatment claims for themselves. On SBM we are constantly stressing the need to apply critical thinking to what you read, and the many pitfalls to be avoided. I’ll try to synthesize some of the principles into a handy list of questions. (more…)

Posted in: Science and the Media

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The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

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As I begin this post, I’m on a miserably crowded, hot, stinky flight winging my way home from TAM. This puts me in the perfect mood to write about my bête noire to conquer all bêtes noires, namely Stanislaw Burzynski, the Polish expat doctor who claims to have much better results treating deadly brain cancers than conventional oncology, even though he is not an oncologist and has never even completed the prerequisite training for an oncology fellowship, namely an internal medicine residency. Actually, I don’t mean that in the way that you probably think I mean it. This time around, unlike the last time around, writing about Burzynski will put me in a better mood to endure being slapped into a sardine can in coach, barely able to move, barely able to type, but needing to get a blog post out on Monday.

If you remember, the last time I wrote about Burzynski, the Food and Drug Administration (FDA) had caved, and by “caved” I mean that it had lifted the partial clinical hold on Burzynski’s clinical trials. As is usual with the long and winding saga that is Burzynski, I feel compelled to give a brief review for any newbie who might encounter this post. Old hands at this story can skip ahead or just skim.

Two years ago, a child named Josia Cotto died of hypernatremia (elevated sodium level in the blood) due to receiving treatment for a brain tumor from the Burzynski Clinic using Burzynski’s “miracle drug” antineoplastons. Hypernatremia is a known complication of ANP treatment, and, as a result of this child’s death, the FDA put a partial clinical hold on Burzynski’s clinical trials for pediatric patients, which meant that he could continue to treat children already enrolled in his clinical trials but could not enroll any new patients. Six months later, this partial hold was extended to all of Burzynski’s clinical trials, and in early 2013 the FDA inspected the Burzynski Clinic and Burzynski Research Institute (BRI). (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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The Truth?

Facepalm
Summertime and the living is easy. I am in Sunriver, Oregon for the week and I though, hilariously, that I would have plenty of time to write a post. Between the hiking, the biking, the golf, the food and the beer, there has been little time to sit in from of a keyboard. There may be no better place to spend a week if you like the outdoors, but they do not have internet on the hike around Paulia Lake. So while a caramel banana cake bakes for a dinner tonight, I have an hour or so churn out a post. Do not expect much.

One person’s ethics is another’s belly laugh, but in medicine ethics are formalized. The basic principles in the US are

  • Respect for autonomy – the patient has the right to refuse or choose their treatment (Voluntas aegroti suprema lex)
  • Beneficence – a practitioner should act in the best interest of the patient (salus aegroti suprema lex)
  • Non-maleficence – “first, do no harm” (primum non nocere)
  • Justice – concerns the distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality).

These are guidelines, not mandated, but if you get an ethics consult in my institutions the above concepts are the framework within which the consult will be completed.

Patients can only be autonomous if they are given accurate, truthful information with which to make a decision about their treatments. You can’t lie to patients, but we all know how you phrase an idea can subtly alter the response. Do you say an 80% success rate or a 20% failure rate? I tend to say both. And not everyone can handle the unvarnished, blunt truth. Part of the art of medicine is trying to tell each patient the truth, the whole truth and nothing but the truth in a manner palatable for the individual patient. It is not easy and I am certain I do not always do a good job. (more…)

Posted in: Medical Ethics, Science and Medicine

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