Pharmaceuticals

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Why Antibiotic Use Scares Me

Editor’s note: Today we present a guest post from fourth-year medical student Joshua Horton, about the looming problem of antibiotic resistance. Welcome!

Antibiotic sensitive (left) and resistant (right) bacterial colonies. They probably shouldn't be that close together.

Antibiotic sensitive (left) and resistant (right) bacterial colonies. They probably shouldn’t be that close together.

I read a study recently that alarmed me: acute bronchitis is a condition that rarely requires antibiotics, but three quarters of patients presenting with this condition receive a prescription for antibiotics. Even more worrisome, this statistic has not changed in 20 years. To those of us on the cusp of a career in medicine – I am a fourth year medical student – this is terrifying because we are going to have to deal with the consequences. Antibiotic overuse leads to:

  • Increased morbidity and mortality for patients infected with resistant bugs
  • Unnecessary and exorbitant healthcare expenditures
  • The potential to cultivate multi-resistant bacteria that could spread to pandemic proportions

We still take them for granted, but antibiotics are a finite resource. Each time we breed a bug that is resistant to a particular drug, we are forced to relinquish that gun from our armamentarium. With fiscal impetus for pharma to develop new antibiotics waning, we may have reached a point of no return. That’s why this study scared me. Hopefully, clever techniques based on behavioral theory designed to reduce antibiotic prescribing may pull us back from that edge – read on to learn more. (more…)

Posted in: Pharmaceuticals, Public Health, Science and Medicine

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Statin Side Effects

statins

A recent article in The New England Journal of Medicine by Andrew L. Mammen, MD, PhD, reviewed statin-associated myopathies. Reading his article prompted me to revisit the subject of statin side effects.

It can no longer be disputed that statins statistically benefit patients who have cardiovascular disease or who are at high risk of cardiovascular disease. But there are still disputable issues. Which patients should be treated? The recent treatment guidelines have been widely criticized. And the actual magnitude of the benefit is small, although we know the benefits are greater for patients at higher risk. It has been argued that as many as 99% of patients who take statins will take them unnecessarily, risking side effects for no benefit. The problem is that we can’t identify which patients those are. Until we learn more, we are stuck treating the many to help the few. As with any medication, there are risks to be balanced against the benefits. What do we really know about the side effects of statins?

Lots of anecdotes, conflicting evidence

It’s very hard to pin down the truth. The Internet is full of anecdotal reports of devastating side effects from statin drugs, including cancer, dizziness, depression, anemia, acidosis, pancreatitis, cataracts, heart failure, hunger, nausea, sleep problems, memory loss, ringing in the ears, “a sense of detachment,”… the list goes on. When symptoms such as these have been evaluated in controlled studies, they have not been shown to occur more often with the drug than with placebo.
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Posted in: Pharmaceuticals

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Patient Beware: Off-label drug promotion by pharmaceutical companies

In truth, physicians are rarely this happy to see a drug rep.

In truth, physicians are rarely this happy to see a drug rep.

Pharmaceutical companies and their sales reps can distribute information, such as medical journal articles, about unapproved (“off-label“) uses of their drugs as long as they adhere to FDA guidelines. However, the FDA takes the position that this information must be distributed separately from information that is “promotional in nature,” i.e., for marketing purposes, a position that is now open to question.

Off-label promotion of a drug for a use that has not been approved by the FDA is, in the FDA’s view, a violation of the federal Food, Drug & Cosmetic Act (FDC Act). It is subject to criminal prosecution, because promoting a drug for new, unapproved uses is evidence of an intent that the drug be used before it has gone through the extensive process of clinical trials and a review of the evidence of safety and efficacy by a panel of experts, as required by law before a drug can be marketed. Thus, off-label promotion is seen as an end-run around the approval process that perverts the purpose of the FDC Act, which is to protect the public from ineffective and unsafe drugs.

Studies show that personal sales visits to physicians by pharmaceutical reps (called “detailing”) drives prescriptions in favor of the drugs being promoted. This is true even though physicians’ view of detailing ranges from neutral to highly negative, a “necessary evil,” and physicians are aware of potential conflicts of interest these visits precipitate.

While there are restrictions on off-label promotion, off-label prescribing by a physician is not illegal. Physician practice is regulated by the states and not within the jurisdiction of the FDA. In fact, off-label prescribing is considered both ethical and within the standard of care in appropriate circumstances. (I am currently taking a drug for an off-label use, and was informed of this, plus the risks and benefits, by my physician prior to his prescribing it.) It is also common, according to an article by law professors Ryan Abbot and Ian Ayers in the Duke Law Journal, which is well worth reading:

for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounts for approximately 21% of prescriptions. Moreover, off-label uses may be the norm in some areas of practice, such as oncology, pain management, and palliative care, and in some patient populations, such as children, the elderly, and the severely ill. For example, about 80 percent of all drug prescriptions for children are off-label, and between 80 and 90 percent of all drug prescriptions for rare diseases are off-label. [Footnotes omitted.]

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

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Stem Cells and Chiropractic

As good a source of stem cells as any chiropractor.

As good a source of stem cells as any chiropractor.

My local newspaper is a constant source of topics to blog about. It regularly features ads for untested dietary supplements and for chiropractors who offer non-chiropractic treatments and don’t identify themselves as chiropractors. Recently, a full-page ad for NW Pain Relief Centers trumpeted “Stem Cell Technology Takes Joint Treatment to the Next Level.” It said stem cell treatments could heal and regenerate tissue in conditions such as knee osteoarthritis, carpal tunnel, peripheral neuropathy, spinal stenosis, hip pain, and tendinitis. A table titled “Consider these facts” compared stem cell therapy to surgery, saying stem cell treatments involve no known side effects, little or no pain, and immediate recovery; whereas surgery involves complications, poor outcomes, addiction to pain medications, severe pain for months, and a prolonged recovery over months and years. It said, “Call now if you experience any degree of joint pain or discomfort…Space is limited to the first 30 callers!”

A few days later there was another full-page ad for NW Pain Relief Centers, this time for hyaluronic acid injections into the knee for osteoarthritic knee pain. It reprinted the same table of comparisons with surgery, with an additional line comparing costs (that didn’t actually compare costs, but only vaguely mentioned insurance coverage, deductibles, copays, and time off work. It featured the same “Call now, space limited” ploy.

These ads reminded me so much of chiropractic ads that I had to wonder what was going on. They mentioned an “allied team of health professionals.” I guessed there must be at least one MD on their team if they were injecting stem cells and hyaluronic acid into joints. I guessed chiropractors were a prominent part of the team. I guessed right. (more…)

Posted in: Chiropractic, Pharmaceuticals

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Pseudoscience sneaks into Ohio guidelines for non-drug pain treatment

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.

Ohio recently issued Acute Pain Prescribing Guidelines as part of an effort to reduce the epidemic of opioid abuse and death from overdose. They were drafted under the auspices of the Governor’s Cabinet Opiate Action Team (GCOAT), assisted by medical organizations and other groups.

The guidelines include recommendations for non-pharmacologic treatment, a typical feature of pain treatment guidelines and a worthy effort to avoid prescribing opioids for pain. Unfortunately, the guidelines include treatments that are not evidence based and potentially harmful. We’ll return to that issue shortly.

But first, a brief look at the extent of the opioid problem. According to the CDC, opioids are used to treat moderate-to-severe pain and are often prescribed following surgery, injury, or for painful health conditions, like cancer. In the past few years, there has been a dramatic increase in the acceptance and use of prescription opioids for the treatment of chronic, non-cancer pain, such as back pain or osteoarthritis. From 1999 to 2013, opioid prescription and sales in the U.S. have nearly quadrupled, and overdose deaths have quadrupled right along with them. (more…)

Posted in: Acupuncture, Chiropractic, Guidelines, Pharmaceuticals, Politics and Regulation

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Chronic Fatigue Syndrome: Rituximab Revisited

rituximabThree years ago I wrote about an experimental treatment for chronic fatigue syndrome (CFS): rituximab (brand name Rituxan). I was concerned that doctors who offered it, like Andreas Kogelnik, were jumping the gun by offering it before the evidence was in, and that they might be putting patients at risk.

A correspondent who has been following the CFS forums asked me to revisit this issue. She sent me links to forum posts indicating that Dr. Kogelnik is treating CFS patients with the drug, that they are not being enrolled in clinical trials, that information about results is not available, and that at least one patient may have developed a life-threatening side effect. I want to stress that I don’t have any evidence that those statements are true. These are only posts on a forum, and I have no way to verify the information. I tried to get more information from Dr. Kogelnik’s clinic, but was unsuccessful. Nevertheless, even if everything in those forum posts is false, I think the issue is serious enough to bring it to the attention of the public again. My purpose is to provide accurate information about rituximab and to get people to think about the principles involved, not to make claims or accusations or cast any blame. (more…)

Posted in: Pharmaceuticals

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Statins: The Impact of Negative Media Reports and the Risks of Discontinuing Treatment

image courtesy of www.kevinmd.com

Image courtesy of www.kevinmd.com

The evidence is clear: statin drugs are effective in reducing the rate of heart attacks and death in people who have already had a heart attack as well as in people who are at high risk of having one. Some people refuse to believe that evidence; they are statin deniers, similar to the climate change deniers and AIDS deniers (and there are even germ theory deniers!) who manage to disregard the strong evidence that proves their opinions wrong. The deniers demonize statins, cherry-picking studies to minimize the benefits and exaggerate the side effects.

A new study found that negative media reports about statins were correlated with patients discontinuing statin therapy. It also found that discontinuing statin therapy was correlated with an increase in heart attacks and death.
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Posted in: Pharmaceuticals, Science and the Media

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The Amarin case: off-label promotion and a double standard for prescription drugs vs. dietary supplements

Screenshot 2015-10-14 23.04.19

A recent court decision enjoined the FDA from threatening prosecution against a drug manufacturer for off-label promotion of a prescription drug. Based on this and an earlier decision by an appellate court, it appears that the FDA can no longer prosecute a pharmaceutical manufacturer for a truthful and non-misleading off-label promotion to health care professionals, at least within the jurisdiction of the United States Court of Appeal for the Second Circuit, which covers Connecticut, New York and Vermont.

For this reason, the case, Amarin Pharma, Inc. v. FDA (Amarin), received a good deal of attention in the world of drug regulation. (Here is an excellent analysis by two attorneys who practice in the area of drug regulation.) First, we’ll take a look at the issue of off-label promotion. Then we’ll look at an issue that really didn’t engender much comment, but that I find fascinating: how the same substance can be subject to very different regulatory treatment, depending on whether it is sold as a dietary supplement or prescription drug.

Background: Initial approval of Vascepa and subsequent research

In 2012, the pharmaceutical manufacturer Amarin received FDA approval for a new drug, Vascepa, as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (triglycerides ≥ 500mg/dL). Approval was based on a single phase 3 clinical trial.

Following that approval, Amarin designed a second single phase 3 clinical trial to look at the effect of Vascepa on triglyceride levels among statin-treated patients with persistently high triglycerides (≥ 200 and ≤ 500 mg/dL). Pursuant to an agreement with the FDA that, if it met certain conditions, Vascepa would obtain approval for this use, Amarin proceeded with an FDA-approved protocol. As a further condition of the agreement, it also began enrolling patients in a third trial to see if Vascepa actually reduced major cardiac events. (more…)

Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Pharmaceuticals, Politics and Regulation

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“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.

(more…)

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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