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Archive for Pharmaceuticals

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.

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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.

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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. It also leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of taking pleasure from drop kicking yipping puppies through flaming goalposts. (I exaggerate, but only slightly, I assure you.)
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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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