Archive for Pharmaceuticals

“Female Viagra?” Misleading Headlines and Regulatory Dilemmas

addyiThe FDA recently approved flibanserin (brand name Addyi) for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women. The story of flibanserin illustrates several of the issues we have confronted on this blog:

  • It was hyped in the media.
  • Misleading headlines called it the female Viagra.
  • It was initially rejected by the FDA and was approved only after extensive lobbying efforts.
  • The drug is only minimally effective and has a lot of drawbacks.
  • Two of the three supporting scientific studies claimed effectiveness based a surrogate measure but failed to show any measurable improvement in sexual desire.
  • A campaign to support “women’s sexual health equity” pushed for approval, framing it as a step towards correcting what they perceived as gender bias (they claimed the FDA was biased because it had provided Viagra to help men have sex but hadn’t done anything to help women have sex).
  • And the validity of the diagnosis of HSDD itself has been questioned.


Posted in: Pharmaceuticals, Politics and Regulation

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Here be Dragons: Caring for Children in a Dangerous Sea of sCAM

Here be dragons large map

As a pediatrician working in a relatively sCAM-inclined region, it is not uncommon to find myself taking care of patients who are also being followed by so-called alternative medicine practitioners. This often creates a major obstacle to providing appropriate care and establishing an atmosphere of mutual trust in the provider-patient/parent relationship. It usually makes me feel like I’m battling invisible serpents in a sea of sCAM.

While these double-dipping parents utilize a variety of sCAM providers, including naturopaths, homeopaths, chiropractors, and a smattering of “holistic healers”, most are taking their children to one of a few “wellness” centers near my practice where they are seen by actual medical doctors practicing so-called “integrative medicine”. Many of these children have vague, chronic, usually non-specific complaints that are difficult to explain and thus to treat. Some have behavioral and mental health problems, or neurodevelopmental conditions such as autism for which parents are seeking explanations and treatments.

What I find to be a common theme with these patients is that they and their parents are summarily taken advantage of by their alternative care providers when they are given a fictitious diagnosis and treated with a variety of useless potions, elixers, and false hopes. Often, parents bring their children to these providers because they are frustrated by their child’s chronic complaints of fatigue, pain, or other somatic issues that have eluded a satisfactory diagnosis or treatment. Invariably, the diagnosis that has remained so elusive to me is quickly found and treated by these much more “holistic” and open-minded providers. In fact, I have never seen a consultation note from one of these providers indicating any uncertainty as to diagnosis or treatment regimen. Typically a large battery of expensive, inappropriate, and sometimes outright fraudulent lab tests is ordered, often from equally questionable laboratories. Again, there are invariably interesting findings prompting tailored and bizarre treatments. In typical red-flag sCAM fashion, some of these providers have their own supplement store, available online only to their patients, prominently displayed on their website. These providers are perceived as being more holistically informed about health and wellness then “conventional” doctors like myself, as if there are two distinct ways of treating illness and maintaining health…as if there is truly such a thing as alternative medicine.

It can be very difficult to manage patients who are being simultaneously “treated” by such providers. Sometimes the treatments complicate or confuse the picture, but it always indicates a failure of trust in the “conventional” method of practice, which is science and evidence based, and in science itself.

Below are a few examples of patients cared for by my practice and simultaneously followed by alternative medicine practitioners. They provide a good picture of just how problematic these co-practitioners can be. No names or identifying information are revealed. (more…)

Posted in: Diagnostic tests & procedures, Herbs & Supplements, Naturopathy, Pharmaceuticals, Science and Medicine

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An Alternative to Appendectomy: Antibiotics

An appendix, mid-appendectomy.

An appendix, mid-appendectomy.

My title doesn’t refer to alternative medicine, it refers to an alternative within medicine: treating appendicitis with antibiotics instead of surgery. You may be surprised to learn that patients with appendicitis don’t always automatically need an appendectomy. A recent randomized controlled trial in Finland compared surgery to medical treatment.

History of appendicitis treatment

There is an excellent, detailed history of appendicitis available online, complete with anecdotes illustrating its importance. The appendix was not mentioned in early anatomical studies, probably because they were done on animals that didn’t have an appendix. The organ was first described in 1521. The existence of appendicitis (called “typhlitis” until 1886) was gradually recognized during the 19th century, and by the end of that century surgical removal of the appendix had become the standard treatment. Walter Reed, the yellow fever researcher for whom the Army hospital was named, died of a ruptured appendix. King Edward VII’s coronation was delayed while he underwent a life-saving appendectomy.

Appendectomy predated antibiotics, and it was believed that appendicitis would invariably progress to perforation. Once antibiotics were available, doctors experimented with treating appendicitis with them instead of with surgery, starting as early as 1956. The published trials had limitations, so the new study was done to try to get a more definitive answer to the question of whether the antibiotic approach was as effective as the surgical approach.


Posted in: Clinical Trials, Pharmaceuticals, Surgical Procedures

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Legislators want “pharmaceutical cost transparency”. Are they asking the wrong question?

Drug Costs

If science-based medicine is unaffordable, then your care won’t be science-based. Prescription drug costs are one of the biggest concerns in health care today. There seems to be no upper limit on prices, with some new treatments costing over $1,000 per day. The arrival of new drugs to treat (and cure) hepatitis C has created a perfect pharmaceutical storm: highly effective treatments, a large population of potential patients, and huge per-patient costs. It’s renewing the debate about whether important medical treatments are being priced out of the reach of the patients that need them. It’s not just hepatitis. Cancer drug costs are rising as well, driven by more patients and new drugs that in some cases are transforming our expectations about what cancer drugs can do. And while many of us rely on some form of drug insurance to protect us from high drug costs, insurers are struggling with balancing coverage and premiums: A report by Express Scripts paints a grim picture:

An estimated 576,000 Americans spent more than the median household income on prescription medications in 2014. This population of patients grew an astounding 63% from 2013. Further, the population of patients with costs of $100,000 or more nearly tripled during the same time period, to nearly 140,000 people. The total cost impact to payers from both patient populations is an unsustainable $52 billion a year.

This isn’t just an issue in the United States. Prescription drug costs are climbing around the world, because we’re effectively all in this together: We all rely on private companies to bring new drugs to market, and we’re largely buying the same drugs from the same small group of companies. Because ready access to safe and effective prescription drugs is so important to the practice of medicine and the delivery of health care, the pharmaceutical industry is heavily regulated – not just by the FDA, but by regulators worldwide. Yet despite the dual requirements of regulatory disclosure and the financial obligation to be transparent (as many pharmaceutical companies are publicly-held), little is known about how much it costs to bring drugs to market, and how manufacturers arrive at their selling prices. Pharmaceutical manufacturers claim that high drug costs reflect the high costs of research and development (R&D), and provide the incentives for companies to invest heavily and take risks, when many drugs may never make it to market. Are they correct? (more…)

Posted in: Pharmaceuticals, Politics and Regulation, Science and Medicine

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As in 2014, “right-to-try” laws continue to metastasize in 2015

As in 2014, “right-to-try” laws continue to metastasize in 2015

Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as “right-to-try.” Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures, which I likened to Dallas Buyers Club laws. Both Jann Bellamy and I wrote about how these laws are far more likely to do harm than good, and that is a position that I maintain today. The idea behind these laws is to give terminally ill patients access to experimental drugs—in some cases drugs that have only passed phase I testing—that might help them. It’s an understandable, albeit flawed argument. After all, it’s perfectly understandable why terminally ill patients would fight for drugs that give them hope, and it’s just as understandable why politicians and the public would see such a goal as a good thing. In practice, as I will explain again in the context of this update, such laws are far more likely to harm patients than help them. Indeed, as you will see, in the year since the first wave of right-to-try laws have passed, not a single patient that I can find has obtained access to experimental drugs under a right-to-try law, much less been helped by them.

Unfortunately, given how effectively “right to try” has been sold on grounds of providing terminally ill patients hope and as a matter of personal freedom, it’s clear that this wave is not going to abate. Since Colorado passed the very first right-to-try law almost exactly a year ago today, a total of 17 more states now have passed passed similar legislation, the most recent being Tennessee, and 22 others have introduced legislation. It’s a good bet that right-to-try will pass in all of those states, because, as I’ve explained many times before and in many interviews, if you don’t understand clinical trial ethics and science, opposing the concept of right-to-try comes across like opposing Mom, apple pie, and the American flag, and leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of enjoying drop kicking puppies through flaming goalposts.

Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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Less benefit, more risk. Our assumptions about health treatments are probably wrong.

Patient discussing treatment options with a pharmacist.

Patient discussing treatment options with a pharmacist.

I’m a health professional, but sometimes a patient as well. And like most patients, I generally don’t want health decisions being made without my input. Yes, I want the best medical information, and the advice of medical professionals, but ultimately I want to make my own decisions about my care. That’s the norm in health care today, but relatively new in the history of medicine.

Medical paternalism, where patient preferences are secondary (or even ignored), is disappearing. Even informed consent, where patients are given information on risks and benefits, doesn’t adequately describe the drive towards a two-way exchange, with an empowered, engaged patient. Today the goal is shared decision making, which describes a mutual decision that is informed by a health professional’s medical knowledge and advice, but also incorporates a patient’s own preferences and wishes. Truly shared decision-making includes an explicit consideration of a treatment’s expected benefits and potential harms, yet reflects patient values.

Screening is a textbook example of why shared decision-making should be our goal. Given the benefits of a disease screening program may be modest, and not without harms, understanding and incorporating individual preference is essential. Some may value the small but incremental benefits of screening, and choose to be screened despite the risks of false positives, investigations, and possible overtreatment. Given the exact same circumstances, another individual may opt to forgo screening, making a different, yet equally acceptable decision. While there are some health interventions for which the benefits are unequivocal, and others for which the harms are just as clear, most health treatments (and interventions like screening) have both benefits and potential harms that must be carefully assessed within the context of patient preferences. Research published earlier this year has identified a significant barrier to truly effective shared decision-making and risk assessment: Across a wide range of interventions, we routinely overestimate the benefits of health treatments, and underestimate their risks. (more…)

Posted in: Diagnostic tests & procedures, Pharmaceuticals, Science and Medicine, Science and the Media

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Anesthesia-Assisted Rapid Opioid Detox

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor's Office of Drug Control Policy.

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor’s Office of Drug Control Policy.

Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.

How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like naltrexone, methadone and buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.

One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation.


Posted in: Clinical Trials, Legal, Pharmaceuticals, Politics and Regulation

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The DC as PCP? Drug Wars Resume

Coming soon, to a chiropractor's office near you?

Coming soon, to a chiropractor’s office near you?

Chiropractors are once again engaged in intra-fraternal warfare over the chiropractic scope of practice, a saga we’ve chronicled before on SBM. (See the references at end of this post.) Every time it looks like the warring factions have buried their differences, they come rising to the surface like zombies.

The International Chiropractors Association (ICA), representing the “straight” faction, wants chiropractic to continue as a drugless profession. They are happy to detect and correct subluxations, thereby removing “nerve interference” and “allowing the body to heal itself” in the tradition of Daniel David Palmer. But the American Chiropractic Association (ACA) has bigger fish to fry.

This time, the ICA is upset that the ACA House of Delegates up and decided to establish a “College of Pharmacology and Toxicology,” which would operate under the auspices of the ACA Council on Diagnosis and Internal Disorders. The ACA’s announcement of the “College” is rather vague on details:

The purpose of the College is to further educate the chiropractic profession on clinical matters related to the widespread use of both prescription and over-the-counter medications and nutritional supplements.

I e-mailed the ACA several days ago asking for more information but have yet to receive a reply.

The ICA sees this move as yet another attempt by:

forces at work within some organizations actively promoting incorporating drugs into the chiropractic scope of practice.


Posted in: Chiropractic, Herbs & Supplements, Humor, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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Stem cells versus Gordie Howe’s stroke


Note: There is now a major update to this story published here, which explains a lot of the questions remaining in this blog post.

Seven years ago I returned to Michigan, where I was born and spent the first quarter century of my life, after an absence of more than 20 years. In the interim, I had done my surgical residency and earned my PhD in Cleveland, a surgical oncology fellowship in Chicago, and worked in New Jersey at my first academic job for eight and a half years. Then I was lured back with a job in Detroit. One of the odd things about this return after such a long absence was the culture shock, how much I had forgotten about the Detroit area. One of those things that I had forgotten is just how crazy about hockey Michigan, in particular Detroit (meaning the Detroit metropolitan area), is. Detroiters love their Red Wings—love them. Hockey is ingrained in the suburban culture from a very young age, so much so that many Canadians would feel right at home here. Memories of trying and failing to be halfway decent at street hockey and of not being anywhere good enough a skater even to try real hockey as a teen came flooding back to me. (It didn’t help that back then I was approaching six feet tall and weighed only 135 lbs.; “beanpole” didn’t even begin to describe me back then.) In fact, the “cultural center” of the town where I live consists of—I kid you not—a hockey rink and some classrooms that are used for various community functions. No, really, it’s named the city’s Cultural Center.

So it should be no surprise, given how much Detroiters love hockey in general and their Red Wings in particular that it was big news here in late October when Red Wing legend Gordie Howe at age 86 suffered a debilitating stroke that paralyzed the right side of his body, a condition known as hemiplegia. Understandably, there was an outpouring of good wishes for recovery, coupled with retrospectives of Howe’s stellar hockey career. Indeed, I remember that Howe’s condition sounded bad enough from the tenor of the news reports at the time that it seemed likely that he would not survive. But survive he did, and is apparently recovering slowly, with occasional setbacks, such as a recent hospitalization in early December for a suspected “mini-stroke” that turned out to be dehydration and several much smaller strokes before that. The most recent press report I saw before the announcements I’m going to discuss described Howe as on the upswing again.

Then, on Friday, I saw headlines all over the place that were basically similar to this Detroit Free Press headline, “Gordie Howe underwent stem cell clinical trial in Mexico.” The story consisted largely of a press release from Howe’s family that read:

Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Science and the Media

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Using the fear of Ebola to promote the placebo legislation that is “right to try”


Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates. Under this views, these cures, long held back by the dam of the FDA, would flow immediately to the people, and there would be much rejoicing. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.

Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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