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More drugs, more supplements, and potentially more problems

drugs and supplements

Early in my career I was fortunate to be offered a role as a hospital pharmacist, working on an inpatient ward along with physicians, nurses, and a number of other health professionals. My responsibilities included conducting a detailed medication review with each newly admitted patient. We would sit together, often with family members, going through what was sometimes a literal garbage bag full of medications, and documenting the drug, the dose, and the reason for use. I can’t remember the most medications I ever counted, but a dozen or more was normal. Some were taking medications four or five times per day, every day. Were all these drugs necessary? In many cases, no. They’d been started at different times, often by different physicians. Some drugs treated the side effects of other medications. Few had ever had a health professional document them all in a single list. There had rarely been an overall review for safety and appropriateness. Few patients knew the treatment goals of their medications. Often, they’d never been asked about their treatment preferences.

In addition to auditing every prescribed medication, I asked about vitamins, supplements and over-the-counter drugs. I usually encountered the same scenario – multiple products, often without any clear medical need. There were vitamins for “eyes”, tonics for “the blood”, and supplements believed to treat or prevent illness. There was regular (and sometimes dangerous) over-the-counter painkiller consumption. Sometimes all of these combinations were clearly antagonistic: concurrent laxatives and treatments for diarrhea, or sleeping pills taken along with stimulants. Worryingly, few had disclosed the use of many of these products to their physician beforehand.

Medication reviews were a tremendous amount of work – but enormously rewarding. It was not difficult to find one or more cases of drugs potentially causing harm, or situations with clear drug-drug or drug-supplement interaction. In some cases, it was the medications that had put them in the hospital in the first place. Working with the residents and medical staff we could usually find ways to simplify their regimen, often discontinuing one or more drugs, reducing the doses of others, and suggesting ways to cut their supplement and over-the-counter drug use – or at a minimum, reduce the risk that these products could cause problems. Not only did patients end up with simpler medication schedules, we were helping them feel better, too. Before every patient was discharged, they’d get a follow-up visit from me. I’d provide a detailed list of current medications with a simplified schedule designed to make medication use easier. We’d provide copies for them to take to the pharmacy and to any specialist. In many cases, patients were still on a long list of drugs. But we’d cleaved away the most harmful and unnecessary, trying to leave only the medications that were appropriate. (more…)

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

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Testing Testosterone Treatments

hey

Whatever is in this water, it isn’t testosterone

Ponce de Leon is said to have been looking for the Fountain of Youth when he explored Florida. That’s only a myth. Now there’s a new myth, that testosterone supplements are a Fountain of Youth for aging men. Men are urged to get their testosterone levels checked if they have any of a long laundry list of vague symptoms. Anti-aging clinics promote testosterone supplementation in many forms: prescription, bioidenticals from compounding pharmacies, natural remedies, testosterone boosters, and precursors. There are highly inflated estimates of the number of men who need supplementation, often relying on broadened criteria for diagnosis or non-standard lab tests. Testimonials abound: “My depression symptoms disappeared in 20 minutes when I started using Androgel.” (That one’s particularly hard to believe. Suggestion can be powerful.)

Until recently, evidence for the benefits of testosterone supplements was scanty, and there was concern about increased cardiovascular and prostate risks and other side effects. A 2013 study found that while testosterone was clearly indicated for younger men with classic hypogonadism caused by known diseases, a general policy of testosterone replacement in all older men with age-related decline in testosterone levels was not justified. In 2003 an Institute of Medicine panel called for a set of coordinated clinical trials to determine whether testosterone would benefit older men who had low testosterone levels for no known reason other than age and who had clinical conditions to which low testosterone might contribute. The results of those trials are starting to come in. The findings to date were covered in an article in the New England Journal of Medicine in February 2016. The full text is available online.
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Posted in: Pharmaceuticals

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The hijacking of evidence-based medicine

One of our heroes at SBM: John Ioannidis.

One of our heroes at SBM: John Ioannidis.

It’s no secret that I’m a fan of John Ioannidis. So, I daresay, are pretty much all of the editors and regular contributors to this blog. (If you don’t believe me, just type Ioannidis’ name into the blog search box and see how many posts you find.) Over the last couple of decades, Ioannidis has arguably done more to reveal the shortcomings of the medical research enterprise that undergirds our treatments, revealing the weaknesses in the evidence base and how easily clinical trials can mislead, than any other researcher. Indeed, after reading what is Ioannidis’ most famous article, “Why Most Published Research Findings Are False“, back in 2005, I was hooked. I even used it for our surgical oncology journal club at the cancer center where I was faculty back then. This was long before I appreciated the difference between science-based medicine (SBM) and evidence-based medicine (EBM). So it was with much interest that I read an article by him published last week and framed as an open letter to David Sackett, the father of evidence-based medicine, entitled “Evidence-based medicine has been hijacked: a report to David Sackett.” Ioannidis is also quoted in a follow-up interview with Retraction Watch.

Before I get to Ioannidis’ latest, I can’t help but point out that, not surprisingly, quacks and proponents of pseudoscientific and unscientific medicine often latch on to Ioannidis’ work to support their quackery and pseudoscience. They’ve been doing it for years. Certainly, they’re already latching on to this article as vindication of their beliefs. After all, their reasoning—if you can call it that—seems to boil down to: If “conventional” medicine is built on such shaky science, then their pseudoscience isn’t wrong after all, given that the same scientific enterprise upon which conventional medicine is based produces the findings that reject their dubious claims and treatments. Of course, whenever I hear this line of argument, I’m reminded of Ben Goldacre’s famous adage, seen in one form on Twitter here:

The adage can be generalized to all EBM and SBM as well. Just because big pharma misbehaves, EBM has flaws, and conventional medicine practitioners don’t always use the most rigorous evidence does not mean that, for example, homeopathy, acupuncture, or energy medicine works.

Still, when Ioannidis publishes an article with a title provocatively declaring that EBM has been “hijacked,” we at SBM take notice. (more…)

Posted in: Basic Science, Clinical Trials, Medical Academia, Pharmaceuticals, Politics and Regulation

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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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