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What Do You Expect From Your Pharmacy?

What evidence standard should exist for health products sold in pharmacies? That’s today’s bleg, and I’m seeking your input.

In most countries, pharmacy is a registered, self-regulated health profession, with a responsibility to optimize the use of drugs. Pharmacist education consists of several years of university-level education and practical training in real-world health care settings. Pharmacists with advanced degrees and post-graduate residencies are common. Not all pharmacists work in community (retail) pharmacies, but that’s where many pharmacists end up, and it’s the public face of the profession.

In most countries, pharmacies are private businesses, either owned by a pharmacist or by a corporation. They are granted a privileged and exclusive right in the provision of health care: certain health products (both prescription and non-prescription) are only available in pharmacies, because pharmacist consultation and availability has been deemed necessary to maximize the safe use of these products. While it’s a setting for health care (and often the first point of contact into the system), retail pharmacy is a business. Pharmacies count on the retail sale of products for revenue and traffic. And in general, pharmacies have the legal right to stock and sell whatever products they want. Tobacco is one exception, where it is no longer sold in most Canadian pharmacies, but remains prevalent in American pharmacies. And as I discussed in a prior post, when we look internationally there can be considerable differences between which drugs are prescription, and these that can be sold over-the counter.

How Much Evidence?

The evidence standard for products sold in pharmacies is facing increasing scrutiny. Concerns have been raised in several countries that pharmacies may be taking advantage of their privileged status as provers of prescription drugs, and are selling products that aren’t supported by good scientific evidence. Some recent examples:
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Posted in: Pharmaceuticals, Politics and Regulation

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Rx, OTC, BTC – Wading into Pharmacy’s Alphabet Soup

Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may be fatal. In other countries, Drug A is the number one cause of acute liver failure.

Should Drug A be available without a prescription?

Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.

Should Drug B be available without a prescription?
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Posted in: Pharmaceuticals, Politics and Regulation

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Chemotherapy versus death from cancer

Editor’s Note: Having pivoted immediately (and dizzyingly) from attending NECSS and participating with John Snyder, Kimball Atwood, and Steve Novella in a panel on the infiltration of quackery into academia to heading down to Washington, DC for the AACR meeting, I’ve neglected my SBM duties a bit this week. After a packed day of talks at the AACR meeting followed by spending an evening with a friend whom I haven’t seen for a long time (complete with a trip to The Brickskeller), there’s–gasp!–no new material today. Because for some reason a decision was apparently made to cut our panel very short in order to get the conference back on schedule, we were unable to answer anywhere near as many questions from the audience as we had originally hoped, I was thinking of doing a post trying to answer a couple of the questions asked by audience members who came up to me after the panel terminated prematurely, because one of them was a particularly dicey situation. Maybe later this week. In the meantime, here’s something that I wrote about a year ago, which I tweaked a bit. It’s a very serious topic, but I think it appropriate because it discusses exactly what science-based medicine tries to prevent using evidence and what “alternative medicine” claims it can prevent based on no evidence.

I’ve written before about the Daniel Hauser case, a 13 year old boy who last year refused chemotherapy for his Hodgkin’s lymphoma, necessitating the involvement of the legal system. Cases like that of Daniel Hauser reprsent supreme “teachable” moments that–fortunately–don’t come along that often. The antivaccine movement, for instance, will be with us always (or at least, I fear, as long as I still walk this earth and beyond), but cases like that of Daniel Hauser tend to pop up only once every couple of years or even less. As tragic as they are, they always bring up so many issues that I have a hard time leaving them alone.

This time around, I wanted to touch on an issue that has come up frequently in the discussions of this case, and that’s the issue of chemotherapy. Specifically, it’s the issue of how horrible chemotherapy can be. Again, make no mistake about it, chemotherapy can be rough. Very rough. But what is often forgotten is that it can also be life-saving, particularly in the case of hematologic malignancies, where it is the primary therapy. What is also often forgotten or intentionally ignored by promoters of unscientific medicine is that doctors don’t use chemotherapy because they have some perverted love of “torturing” patients, because they’re in the pockets of big pharma and looking for cash, or because they are too lazy to find another way. They do it because, at least right now, it’s the best therapy science-based medicine has to offer, and in the case of Hodgkin’s lymphoma, for example, it’s life-saving. You can be sure that if a less harsh way were found to achieve the same results, physicians would jump all over it. Indeed, a major focuse of oncology research these days is to find less brutal regimens and improve the quality of life of cancer patients while still giving them the best shot at survival.
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Posted in: Cancer, Pharmaceuticals

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Genetic Testing for Patients on Coumadin

Anticoagulation is advised for patients who have had a blood clot or who are at increased risk of blood clots because of atrial fibrillation, artificial heart valves, or other conditions. Over 30 million prescriptions are written every year in the US for the anticoagulant warfarin, best known under the brand name Coumadin. Originally developed as a rat poison, warfarin has proved very effective in preventing blood clots and saving lives; but too much anticoagulation leads to the opposite problem: bleeding. A high level of Coumadin might prevent a stroke from a blood clot only to cause a stroke from an intracranial bleed. The effect varies from person to person and from day to day depending on things like the amount of vitamin K in the diet and interactions with other medications. It requires careful monitoring with blood tests, and it is tricky because there is a delay between changing the dose and seeing the results.

In his book The Language of Life, Francis Collins predicts that Coumadin will be the first drug for which the so-called Dx-Rx paradigm — a genetic test (Dx) followed by a prescription (Rx) — will enter mainstream medical practice. FDA economists have estimated that by formally integrating genetic testing into routine warfarin therapy, the US alone would avoid 85,000 serious bleeding events and 17,000 strokes annually.
A recent news release from the American College of Cardiology described a paper at their annual meeting reporting a study of

896 people who, shortly after beginning warfarin therapy, gave a blood sample or cheek swab that was analyzed for expression of two genes — CYP2C9 and VKORC1 — that revealed sensitivity to warfarin. People with high sensitivity were put on a reduced dose of warfarin and had frequent blood tests. People with low sensitivity were given a higher dose of warfarin.

During the first six months that they took warfarin, those who underwent genetic testing were 31 percent less likely to be hospitalized for any reason and 29 percent less likely to be hospitalized for bleeding or thromboembolism than were a group that did not have genetic testing.

Epstein said that the cost of the genetic testing — $250 to $400 — would be justified by reduced hospitalization costs.

At this point, I don’t believe this study. I’ll explain why I’m skeptical. (more…)

Posted in: Clinical Trials, Pharmaceuticals

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The Tamiflu Spin

I will start, for those of you who are new to the blog, with two disclaimers.

First, I am an infectious disease doctor. It is a simple job: Me find bug. Me kill bug. Me go home. I spend all day taking care of patients with infections. My income comes from treating and preventing infections. So I must have some sort of bias, the main one being I like to do everything I can to cure my patients.

Second, in 25 years I have, to my knowledge, accepted one thing from a drug company. The Unisin (that’s how I spell it) rep, upon transfer from my hospital, sent me a Fleet enema with a Unisin sticker on it. I show it proudly to all who enter my office. I do not even eat the drug company pizza at conference, and I cannot begin to tell you painful that is.

As we leave (I hope) the H1N1 season and enter seasonal flu season, there has been a flurry of articles, originating in the British Medical Journal , questioning whether oseltamivir is effective in treating influenza. The specific complaint at issue is whether or not oseltamivir prevents secondary complications of influenza like hospitalization and pneumonia. Although you wouldn’t guess that was at issue from the reporting.  As always, there is what the data says, what the abstract says, what the conclusion says, and what other people say it says.  Reading the medical literature is all about blind men and elephants.

There is, evidently, going to be an investigation by the European Union Council of Europe  into whether or not the H1N1 pandemic was faked to sell more oseltamivir. Sigh.
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health, Science and the Media

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Don’t Believe The Hype: Cholinesterase Inhibitors As A Treatment For Dementia

Don’t Believe The Hype: Cholinesterase Inhibitors As A Treatment For Dementia
I distinctly remember the day I attended a “drug lunch” (as a PM&R resident in New York City) to learn about the value of donepezil (aricept) for the treatment of dementia. I was astonished by the drug’s lack of efficacy – the graph displayed in the PowerPoint show demonstrated a 2-point improvement on the Mini Mental State Exam (MMSE), an effect that began after 6 months of donepezil use, and persisted for only 6 months after that. A 2-point difference on the MMSE has no clinical relevance of which I’m aware. The drug’s common side effects include: nausea, vomiting, diarrhea, loss of appetite, tiredness, drowsiness, trouble sleeping, or muscle cramps. That day I vowed never to prescribe the drug to my elderly patients.
Nonetheless, I was dumbfounded by the number of patients who came to the hospital already on the medication. Over and over again I heard the same story: “mom is becoming forgetful so our doctor started her on this medication to help her memory.”
When I asked if the family if they thought the medicine helped, the response was equally predictable: a shrug and then “what else can we do?”
Here we have a classic example of a medical problem with no satisfactory treatment or cure – and a desperate desire on the part of patients and family members to do something – anything – about it. Many times people in these predicaments turn to alternative medicines, herbal supplements and faith –based remedies. And sometimes they turn to FDA-approved drugs.
The Cochrane Collaborative has reviewed the scientific literature on the use of cholinesterase inhibitors (like donepezil) in mild dementia, and has found:
There is no evidence to support the use of donepezil for patients with mild cognitive impairment (MCI). The putative benefits are minor, short lived and associated with significant side effects. http://www.cochrane.org/reviews/en/ab006104.html
So how did this drug get approved? Well, there do seem to be some small improvements (of dubious clinical significance in my opinion) in measures of cognitive impairment in patients with Alzheimer’s dementia in particular. http://www.cochrane.org/reviews/en/ab005593.html
AHRQ states:
The evidence is mixed, however, about the effects of cholinesterase inhibitors on functional measures such as instrumental activities of daily living (i.e., ability to use the telephone, mode of transportation, responsibility for medication, and ability to handle finances). In general, the studies show little or no effect on functional decline after 6 months of treatment and a small but statistically significant difference from placebo after 12 months of treatment.
Research has found no clinically important differences between people taking cholinesterase inhibitors and those taking placebo in the development of behavioral and psychological symptoms… Studies rarely addressed other important health outcomes such as utilization of health care services, injuries, and caregiver burden.
http://www.ahrq.gov/clinic/3rduspstf/dementia/dementsum.htm
Pfizer’s press release (when they received FDA approval to market Aricept in 1996) noted:
Alzheimer’s disease is a family tragedy. ARICEPT will benefit patients and families alike by improving or maintaining patient function, which in turn may help ease the burden for caregivers and help maintain personal dignity… “ARICEPT represents a significant step forward in addressing the therapeutic needs of the Alzheimer’s disease community…This therapy will help to change the approach to the management of Alzheimer’s disease.
http://www.pslgroup.com/dg/e2aa.htm
Global sales of Aricept were approximately $1.1 billion for 2008 alone.
Me-too cholinesterase inhibitors have seen similar global profits, with sales of namenda at about $1 billion as well in 2008. http://www.businessweek.com/magazine/content/04_14/b3877629_mz073.htm All this while the AHRQ can find no clinically relevant difference between the drugs in this class, and the effects they have are small and short lived.
There are pharmaceutical innovations that have changed the course of history (imagine where we’d be without the polio or smallpox vaccines), while others leverage the tiniest statistically-significant effects to drive global drug empires driven by public feelings of helplessness in the face of currently incurable diseases.
It’s no wonder that the public has a mistrust of pharma – their marketing engines drive sales of drugs that have vastly different clinical value. That means it’s up to physicians and scientists to tease out the legitimate enthusiasm from the marketing hype. And judging from all the patients with mild dementia that I see on cholinesterase inhibitors, I give us a failing grade.

I distinctly remember the day I attended a “drug lunch” (as a PM&R resident in New York City) to learn about the value of donepezil (Aricept) for the treatment of dementia. I was surprised by the drug’s lack of efficacy – the graph displayed in the PowerPoint show demonstrated a 2-point improvement on the Mini Mental State Exam (MMSE), an effect that began after 6 months of donepezil use, and persisted for only 6 months after that. A 2-point difference on the MMSE has no clinical relevance of which I’m aware. The drug’s common side effects include: nausea, vomiting, diarrhea, loss of appetite, tiredness, drowsiness, trouble sleeping, or muscle cramps. That day I realized that the risk-benefit profile did not support its use.

Nonetheless, I was perplexed by the number of patients who came to the hospital already on the medication. Over and over again I heard the same story: “Mom is becoming forgetful so our doctor started her on this medication to help her memory.” (more…)

Posted in: Pharmaceuticals

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James Ray and testosterone replacement therapy (TRT)

For the last four years I have served in a volunteer capacity among a panel of pharmacotherapy experts queried regularly by the ABC News Medical Unit about breaking or upcoming news involving the efficacy and safety of drugs and supplements. Where appropriate, I provide background information that informs the story.

My incentive is largely to put my time where my mouth is when I say that scientists need to take a more active role in making sure medical stories are reported accurately. An additional dividend is paid to my students who then benefit from my presentation of the science behind timely medical developments.

On occasion, perhaps once or twice a year, I’ll be asked for an on-camera interview. Even when this occurs, the resulting story will contain no more than 15 seconds of the interview and some summary by the reporter of other issues we discussed. I take this responsibility very seriously and prepare as much as I can given the deadlines of the press and my daily education and research schedule.

But given airtime constraints, much of what I prepare would normally end up in the abyss of my files and come out in the classroom when I lecture about that particular topic. Blogging, however, now allows us to expand further on stories where we are consulted, giving us an opportunity to air, albeit to a smaller audience, the information we found important from our perspective. Authoring a blog, therefore, takes away the excuse some scientists and physicians have in not wanting to talk to the press: “There’s never enough airtime to tell the whole story the way I would tell it.”

This post was informed by one of those brief appearances, this time on ABC World News Sunday with Dan Harris. The interview was solicited last weekend following the release of information obtained during the execution of a search warrant in lodging occupied by the self-help guru, James Arthur Ray, who led an Arizona sweat lodge ceremony last October where three people ultimately died and almost two dozen were hospitalized. The segment was not archived to the World News website but some ABC affiliates subsequently aired truncated versions of the story.
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Posted in: Diagnostic tests & procedures, Pharmaceuticals, Science and the Media

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Osteoporosis Drugs: Good Medicine or Big Pharma Scam?

A recent story on NPR accused the drug manufacturer Merck of inventing a disease, osteopenia, in order to sell its drug Fosamax. It showed how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution.

Osteoporosis is a reduction in bone mineral density that leads to fractures. The most serious are hip fractures, which require surgery, have complications like blood clots, and carry a high mortality. Many of those who survive never walk again. Vertebral fractures are common in the osteoporotic elderly and are responsible for dowager’s hump and loss of height. There is also an increased risk of wrist and rib fractures.

Bone density tends to decrease with age. Postmenopausal women are particularly susceptible to osteoporosis when their production of estrogen declines. The risk is increased in people taking corticosteroids and in people with certain diseases like rheumatoid arthritis. Other risk factors are European or Asian ancestry, smoking, excess alcohol, a family history of fractures, vitamin D deficiency, too much or too little exercise, malnutrition, and low body weight.

When a measurement like bone density varies widely in a population and decreases with age, how can we decide where to draw the line and call it abnormal? When does it become a disease requiring treatment? (more…)

Posted in: Pharmaceuticals

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Recombinant Human Antithrombin – Milking Nanny Goats for Big Bucks

Antithrombin deficiency is a hereditary disease causing low levels or defects of antithrombin, a blood protein required for controlling clot formation. Patients are at risk of blood clots, organ damage, and death. They usually have to take oral anticoagulant drugs like warfarin for life.

During high-risk procedures like surgery or childbirth, oral anticoagulants must be discontinued to minimize the chance of bleeding complications. While patients are off oral anticoagulants, they are given preventive treatment with antithrombin derived from pooled human blood. With any human blood product there is a small risk of infection with diseases like hepatitis C. And human antithrombin supplies are not plentiful.

Clever researchers found an ingenious solution. Put a human antithrombin gene in goats, milk them, isolate the human antithrombin protein from the milk, and voila! An udderly safe and plentiful source. A Brit might call it bleatin’ brilliant. (more…)

Posted in: Pharmaceuticals, Science and Medicine

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All Medicines Are Poison!

That’s the title of a new book  by Melvin H. Kirschner, M.D. When I first saw the title, I expected a polemic against conventional medicine. The first line of the Preface reassured me: “Everything we do has a risk-benefit ratio.” Dr. Kirschner took the title from his first pharmacology lecture in medical school. The professor said “I am here to teach you how to poison people.” After a pause, he added, “without killing them, of course.” 

He meant that any medicine that has effects has side effects, that the poison is in the dose, and that we must weigh the benefits of any treatment against the risks. Dr. Kirschner has no beef with scientific medicine. He does have a lot of other beefs, mainly with the health insurance industry, the pharmaceutical industry, and alternative medicine. (more…)

Posted in: Book & movie reviews, Pharmaceuticals

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