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“Low T”: The triumph of marketing over science

A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel…for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.

The Colbert Report, December 2012

 

And now for something completely different…sort of.

After writing so much about the latest developments in the ongoing saga of the cancer doctor who is not an oncologist and not a legitimate cancer researcher, plus a rumination on what’s up with President Obama’s nominee for Surgeon General and our favorite form of unscientific medicine, so-called complementary and alternative medicine (CAM), also known as “integrative medicine,” I thought it was time for a change of pace. I wasn’t sure what I was going to write about as Sunday rolled around, but fortunately, as sometimes happens, the New York Times dropped a topic right in my lap, so to speak, both figuratively and literally. It comes in the form of a long article on something that directly concerns men of a certain age, which unfortunately happens to mean men of my age and older. I’m referring to what pharmaceutical company advertising campaigns have dubbed “low T,” short for low testosterone. It’s not clear how the term “low T” originated but Dr. Abraham Morgentaler, founder of Men’s Health Boston, claims to have coined the term when his patients were embarrassed by their difficulty pronouncing the word “testosterone.” Other sources report that it was Solvay Pharmaceuticals that coined the phrase. It doesn’t really matter where the term “low T” came from. The term has stuck, even though the more “correct” medical term would be hypogonadism, as in a man’s testes not working.
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Posted in: Clinical Trials, Pharmaceuticals, Science and the Media

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Student Health Professionals and Attitudes about CAM

While I’m now two full decades out of pharmacy school, I am occasionally invited to return to give a lecture or facilitate a workshop. Pharmacy education has changed a lot since the 1990′s. For me, pharmacy was a Bachelor’s degree program you started right out of high school. Today, students must have a few years of university completed before they can apply (some already have one degree), and the more common degree granted is doctorate-level, the Pharm.D. The clinical training has been bulked up and the practical training is much more rigorous. I see all this as positive change, as the practice of pharmacy has changed along with the education standard. The era of the “count, pour, lick and stick” pharmacist is disappearing as these tasks are automated or delegated to others. Today’s pharmacist has the opportunity to deliver care in different ways, including new roles like vaccine provider, and medication review/drug therapy optimizer. Many find positions that allow them to leverage their drug-related expertise to other areas of the healthcare system.

With pharmacists’ knowledge of drug products it should not be a surprise that they are consulted widely for advice by patients as well as other health professionals. Public surveys on trust show pharmacists lead other health professionals on this measure. It should also not be a surprise that pharmacists can be quite influential in shaping drug use, particularly when it comes to advice about complementary and alternative medicine (CAM), especially when it is used with conventional, science-based drug treatments. After all, drug stores are becoming (to my professional embarrassment) purveyors of all forms of CAM, ranging from homeopathic “treatments” through aisles of herbal remedies, vitamins, and other supplements. One pharmacy I used to work at sold copper bracelets, magnets, salt lamps, ear candles, homeopathic “first aid” kits, and detox packages that were purported to “balance” your pH. If there was a plausibility limit to what this pharmacy would sell, I never saw it reached. I gave the best science-based advice I could, but eventually left due to my concerns about what was on the shelves. But my time in that setting showed me the opportunity to improve care: the pharmacist is well positioned to advise on the evidence for or against any particular treatment, as well as the describe the potential risks with combining CAM with evidence-based treatment approaches. (more…)

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

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Acetaminophen: Still the pain reliever you should trust?

Recently ProPublica and This American Life (TAL) released the results of an investigation into acetaminophen, the active ingredient in Tylenol. TAL devoted an entire episode to the issue, and ProPublica has published several stories on acetaminophen’s toxicity, how it can cause harm, and how it is regulated.

The investigation summarizes the key “Takeaways” as follows:

  • 150 Americans die per year from accidental acetaminophen overdoses
  • The safety margin (safe dose vs. toxic dose) with acetaminophen is small
  • Both the FDA and the manufacturer, McNeil, have known about the toxicity for years
  • For over 30 years the FDA has failed to implement measures to reduce the risk of harms it knew existed
  • The manufacturer has taken steps to protect consumers but has also opposed other safety measures

While Tylenol is a single brand out of hundreds of prescription and non-prescription products that contain acetaminophen as an active ingredient, it is the brand most closely associated with the chemical. Amazingly for a drug that has no patent and lots of competition, Tylenol products are estimated to make up half of all non-prescription acetaminophen sales in the US, a testament to the power and effectiveness of marketing. (It’s also a clear refutation to alt-med arguments that unpatented products can’t be profitable, or aren’t of interest to the pharmaceutical industry.) While much of the focus of the investigation centers on the corporate behavior of Tylenol’s manufacturer, McNeil, (a division of Johnson & Johnson), it is important to keep in mind that no single company is responsible for acetaminophen sales and marketing. (more…)

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

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The Bendectin Controversy Redux?

When I read that a new study had shown that antihistamines were harmful for patients with morning sickness, I cringed and thought “Here we go again.”

Hyperemesis gravidarum (HG) is a serious complication of pregnancy. Simple morning sickness is more common and less serious. When I started out in medicine, we routinely treated morning sickness with Bendectin. It was a safe and effective remedy, a combination of the antihistamine doxylamine and a B vitamin, pyridoxine. Unfortunately the manufacturer, Merrill Dow Pharmaceuticals, was bombarded with numerous lawsuits claiming that Bendectin caused birth defects. There was a clear scientific consensus that the evidence did not show that Bendectin caused birth defects and there was plentiful evidence of its safety. The lawyers prevailed over the science, and in 1983, Dow voluntarily took Bendectin off the market to avoid further litigation expenses. After the drug’s withdrawal, the rate of birth defects did not decrease, but the rate of hospitalization for hyperemesis gravidarum doubled. (more…)

Posted in: Legal, Obstetrics & gynecology, Pharmaceuticals

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Antibiotics for Low Back Pain

Low back pain is a particularly frustrating condition that is common, poorly understood, and difficult to treat. Could a long course of antibiotics be the answer for some patients? A recent study from Denmark suggests that it might be:  “Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy” by Albert, Sorensen, Christensen and Manniche.  Is this a crazy idea like long-term antibiotics for “chronic Lyme disease” or will it pan out like antibiotic eradication of H. pylori in patients with ulcers? Time will tell. This was a rigorous, well-done study, but we can never rely on the results of a single study until it is replicated or confirmed elsewhere.
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Posted in: Clinical Trials, Pharmaceuticals

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Anti-inflammatory drugs: A closer look at the risks

If science-based medicine reflects the application of the best evidence, then we should expect practices to change when new data emerges. In the long run that’s generally true, and the progressive gains we’ve seen in the management of disease reflect this. But in the short run, change can be maddeningly slow, and there are many areas of medicine where we could be doing a better job of applying what we already know to improve outcomes and reduce harms. One area where this is obvious is drug treatments, which can provide remarkable benefits but are also sources of significant harms.

Somewhat problematically, the real world is often the setting where the full extent of harms from treatments are identified. Bringing new drugs to market means tradeoffs: Do you demand larger and longer clinical trials to get as much information as possible about a drug before it’s sold? Or do you approve based on more preliminary, potentially weaker evidence, to meet (potentially) important patient need? There is no set formula or right answer to this questions – it’s ultimately a value judgement exercised by regulators like the FDA, who decide which drugs are allowed for sale (the benefits are assumed, overall, to exceed the harms) or removed for sale (when the opposite is felt to be the case).
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Posted in: Pharmaceuticals

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Legislative Alchemy: Chiropractic 2013

Via the magic of legislative alchemy, chiropractors are already licensed health care providers in all 50 states. Thus their legislative efforts tend to focus on expanding their scope of practice and forcing public and private insurers to cover their services, in some cases at the same rate as medical doctors. Those efforts continue in 2013 with 65 bills impacting chiropractors introduced so far. Of those including substantive provisions (as opposed to, say, simply raising fees), only one is not to their advantage.

New Mexico chiropractors are once again attempting expansion of their scope of practice. In 2008 and 2009, the New Mexico legislature created a new iteration of chiropractor, called “the certified advanced practice chiropractic physician.” A certain faction of the chiropractic industry is attempting to rebrand chiropractors nationwide as primary care physicians and this was a signature event in those efforts. With 90 hours of additional education, these advanced practice chiropractors can administer a bevy of dubious remedies, such as bioidentical hormones.

The new law also permitted prescription of dangerous drugs and controlled substances and administration of drugs by injection, but only if on a formulary approved by the state pharmacy and medical boards. The chiropractic board didn’t like having to get approval from pharmacists and medical doctors, so they went ahead and added what they wanted to the formulary, ignoring the other boards despite their own attorney’s advice that they couldn’t do this. This got them into a couple of court battles with the pharmacy and medical boards. The International Association of Chiropractors (ICA), the traditional, subluxation-only chiropractic faction, jumped into the fray to oppose this power grab. The ICA believes chiropractic should remain drug and surgery free.

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

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Legislative Alchemy: Naturopathy 2013

A fresh season of state legislative sessions is upon us and with it comes the ubiquitous attempts by purveyors of so called “complementary and alternative medicine” (or “CAM”) to join the health care provider fraternity. Via the magic of legislative alchemy, state legislatures transform pseudoscientific diagnoses (e.g., “chronic yeast overgrowth”) and treatments (e.g., homeopathy) into faux, but legal, health care. Once the imprimatur of legitimacy is bestowed by the state in the form of a health care practice act tailored to their special brand of quackery, these newly licensed health care providers are free to foist their practices onto an unsuspecting public and charge them for the privilege. All of this is done under the false assumption that such legislation is necessary to protect the public health, safety and welfare.

We might well want to consider how far this whole thing is going. Will practitioners of CAM split into an ever-expanding number of CAM provider guilds, all with their own practice acts? First, chiropractors were the only CAM practitioners who managed to get themselves licensed in all 50 states. Then along came acupuncturists, who are now licensed to practice in over 40 states. A few states license homeopaths. Some states licensed naturopaths early on. Now the naturopaths, licensed in 16 states, are in a full court press to catch up and legitimize themselves with licenses to practice “naturopathic medicine.”

Why? Because, according to Lorilee Schoenback, ND, a Vermont practitioner and American Association of Naturopathic Physicians (AANP) Board member:

If the law [the Affordable Care Act, or ACA] is implemented as intended NDs in 16 states will immediately be covered by insurance.

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Posted in: Herbs & Supplements, Homeopathy, Legal, Naturopathy, Pharmaceuticals, Politics and Regulation, Public Health

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Rituximab for Chronic Fatigue Syndrome: Jumping the Gun

Now that the XMRV myth has been put to rest,  patients with Chronic Fatigue Syndrome (CFS) are no longer jumping the gun to demand anti-retroviral treatments. But they are jumping the gun in new ways, based on very preliminary data coming out of Norway.

A correspondent in Norway wrote to tell me patients from Norway with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) are travelling to the US to have Dr. Andreas Kogelnik in San Francisco treat them with IV infusions of rituximab, apparently to no avail. A course of treatment costs over $6000, not to speak of travel and other expenses. (more…)

Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals

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What does a new drug cost? Part II: The productivity problem

A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and also to bring newer, better therapies to market. It’s great when there are lots of new drugs appearing, and they’re affordable for consumers and health systems. But that doesn’t seem to be the case. Pipelines seem to be drying up, and the cost of new drugs is climbing. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we’re told, because developing drugs is a risky, costly, time consuming endeavor. The high prices for new treatments are the price of innovative new treatments, both now and in the future. Research and development (R&D) costs are used to argue against strategies that could reduce company profitability (and presumably, future R&D), be it hospitals refusing to pay high drug costs, or changing patent laws that will determine when a generic drug will be marketed.

The overall costs of R&D are not the focus in Goldacre’s book, receiving only a short mention in the afterword, where he refers to the estimate of £500 million to bring a drug to market as “mythical and overstated.” He’s not alone in his skepticism. There’s a fair number of papers and analyses that have attempted to come up with a “true” estimate, and some authors argue the industry does not describe the true costs accurately or transparently enough to allow for objective evaluations. Some develop models independently, based on publicly available data. All models, however, must incorporate a range of assumptions that can influence the output. Over a year ago I reviewed at a study by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research, which estimated R&D costs at a tiny $43.4 million per drug – not £500 million, or the $1 billion you may see quoted.  Their estimates, however, were based on a sequence of highly implausible assumptions, meaning the “average” drug development costs are almost certainly higher in the real world. But how much higher isn’t clear. There have been at least eleven different studies published that estimate costs. Methods used range from direct data collection to aggregate industry estimates. Given the higher costs of new drugs, having an understanding of the drivers of development costs can help us understand just how efficiently this industry is performing. There are good reasons to be critical of the pharmaceutical industry. Are R&D costs one of them?

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Posted in: Clinical Trials, Pharmaceuticals, Politics and Regulation

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