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Is the placebo effect real? A closer look at the PLoS study on the benefits of placebo in treating Irritable Bowel Syndrome (IBS).

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If only placebo effects were real …

The journal PLoS published a randomized, controlled study reporting the benefits of placebo in the treatment of Irritable Bowel Syndrome (IBS).  The study, based on the idea that the body has a “powerful self-healing network,” has been purported to demonstrate that placebos actually do something beneficial for patients’ diseases and are “profoundly good news to anyone but investors in Pfizer, Roche and GlaxoSmithKline”.

I wouldn’t rush to sell my shares in drug companies (full disclosure: I don’t have any such shares, except perhaps within mutual funds) or give up on the benefit of FDA-approved medications.  The PLoS study compared two groups:

  • Patients who were told they were being given a placebo (and were told that the placebo effect is powerful, the body can automatically respond to taking placebo pills like Pavlov’s dogs who salivated when they heard a bell, a positive attitude helps but is not necessary, and taking the pills faithfully is critical), and
  • Patients who were told they were being given no treatment.

The study assessed the patients’ report of how they were doing. There was no objective measure included to test whether there was any change in inflammation or any other real change in the body from the treatment.

The study did find a difference in what patients reported.  The study found a statistically significant  global improvement in the group given placebo compared to the group getting no treatment.  That sounds good, but global improvement was measured on a 1 to 7 scale.  On average, the no treatment group reported no change, while the placebo group reported just slight improvement, not moderate or substantial improvement.  As is done all too often, the graph of the results that was published in the PLoS study lopped off large portions of the scale in what seems to me to be an attempt to make the global improvement results look more significant than they really were.

These two graphs show the same data. The graph on the left shows how the data was presented in the study, magnifying the apparent improvement associated with placebo, while the graph on the right provides a more accurate illustration of the degree of benefit found.

The PLoS study does show that patients who are told they are being given a placebo report slight improvement in their condition, but the placebo may only be changing how the patients respond to a survey, not any actual change in their condition.  The PLoS study did not look for, much less demonstrate, any benefit in any objectively measurable sign of actual healing.

I’m quite enthusiastic about some of the modern miracle drugs we have.  They’ve been rigorously tested and proven to help correct physiologic changes associated with a wide range of diseases.  I specialize in the treatment of psoriasis.  New miracle drugs like etanercept, infliximab and adalimumab are extraordingary treatments for patients with severe psoriasis.  In the study of those drugs, placebo groups had improvements in their psoriasis of about 15 to 20 percent.  But that improvement appears to be largely due to the way the study was done, not to actual improvements in the disease.

Placebo effects may be great in theory, but they appear ephemeral, disappearing when subjected to close scrutiny.

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I received an email from the National Psoriasis Foundation about some of their recent accomplishments.

If you or a family member have a chronic illness, consider joining a patient advocacy group.  You can learn about diseases, find out about new treatments or even help support research toward a cure.  You can find a comprehensive  list of patient advocacy groups on DrScore.com.

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A National Psoriasis Foundation survey reports that one in three people with psoriasis do not receive proper treatment for their disease due to health insurance issues. There are modern medical miracles to be had, but one of the biggest problems we face today is simply accessing them.

Here are some things to keep in mind:

  • If the insurer says no to paying for a certain treatment, appeal.
  • If they still say no, consider contacting a patient advocacy group (we have a list on the home page of DrScore.com, just scroll down to the bottom). In the case of psoriasis, it would be the National Psoriasis Foundation. You could also contact your state insurance commissioner. I suspect that if the treatment really is appropriate, most times the insurer will cover the product on appeal.
  • Also, look into patient assistance programs. My personal experience is that there are some generous programs out there designed for people who can’t afford the medication or even the copay. You can start at http://www.pparx.org/.

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While problems with FDA-approved medications make huge news, I encourage people to have great confidence in FDA-approved products.

When we learn of problems with FDA-approved products, the problems are usually very uncommon to very rare, and they are only detectable when huge numbers of patients have been treated. One psoriasis drug was approved based on studies of thousands of patients. When three or four patients (out of tens of thousands treated) were found to develop a rare infection, the drug was taken off the market. No drug is completely safe, but even this rare event was enough for this drug to be taken off the market.

The recent recall of some McNeill products (http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc) heightens my perception of the safety of FDA-approved products.  “Glass is half empty” kind of people might think a recall is a sign that there’s a safety problem. But the opposite is true, in my opinion. Here the drug was recalled without any known safety problem being evident. It was just an extra precaution.

That degree of caution is the kind of caution that should give the public a strong reassurance that their FDA-approved medications are safe to take under the direction of their physician. When it comes to products that aren’t FDA-approved, people should be wary.

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As a dermatologist, I see many patients who have psoriasis. One of the most valuable resources I can offer my psoriasis patients is the National Psoriasis Foundation, an organization of people devoted to improving the lives of people with psoriasis through education, advocacy and research.  

A National Psoriasis Foundation volunteer, 17-year old Lauren Henschel, was named one of Florida’s top youth volunteers for her work with the foundation’s Walk to Cure Psoriasis in Miami. Way to go, Lauren! This is an event that she and her family spearheaded to raise money for research and to dispel common misconceptions about psoriasis. Their local walk has helped generate more than $750,000 to support psoriasis research and education in the past four years. With young leaders like Lauren, the future is looking bright. 

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Patient advocacy groups are a huge help to patients. As a dermatologist who specializes in treating patients with psoriasis, I have had the opportunity to work extensively with the National Psoriasis Foundation over the past 20 years. Like so many other patient advocacy groups, the Psoriasis Foundation is a wonderful group of people dedicated to finding a cure, to educating patients, doctors and the public, and to advocating on behalf of patients.

The Foundation is creating a nationwide network of psoriasis activists. They will be organized through the National Psoriasis Foundation’s new community divisions. If you have psoriasis, I encourage you to check this out. It may be just what you are looking for. If you have some other chronic disease, there is likely to be a patient advocacy group for you, too. You can get a list of many of these at the DrScore.com website, http://www.drscore.com/advocacy/list.cfm.

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The news reported that cocaine may be adulterated with other dangerous drugs (http://www.bloomberg.com/apps/news?pid=20601124&sid=aN454DsoGaj4). Cocaine itself is a dangerous, potentially lethal, product. The take home message of this story is that unscrupulous manufacturers can adulterate any unregulated substance.

The FDA has documented many examples of so-called herbal and natural remedies that have been adulterated with real drugs (http://www.fda.gov/NewsEvents/Testimony/ucm184497.htm). Watch out. I have a lot of faith in the purity of regulated, prescription products. I have a lot of faith in over-the-counter products produced by large companies that have reputations to protect. I’d be circumspect about too-good-to-be-true claims of “natural” products that are supposed to work like miracles without drug side effects, especially when fly-by-night companies market those products.

Back in the 1990s, one of the most effective products ever seen for patients with skin disease was introduced and marketed as “natural”: a spray-on zinc product. Some thought it was a miracle cure for psoriasis. But then, lo and behold, researchers analyzed the product and found that it contained one of the most powerful steroids known to man.

We hear all about the side effects of real drugs. No drug is completely safe. Large clinical trials and careful follow up studies of drugs in widespread use are able to identify rare but serious side effects and increased risks of drug products. We know a lot about the benefits and risks of regulated drug products. It is folly to think that natural products are going to be able to magically produce the benefits of real drugs without any of the risks.

I’m not saying there isn’t a place for non-medicinal products. I am saying: Be Careful! Make sure you let your physician know all the products you are using, even if they aren’t prescription products. And take special care with products that come from companies you’ve never heard of. Such companies may have something to gain and little to lose by adulterating their products.

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The issues raised in the This American Life program on health care reform resonated with me as they are common issues in my practice. As a dermatologist, one of the most common problems my patients have is psoriasis, a red, scaly rash that can affect different parts of the skin. These spots on the skin are caused by inflammation; in other words, they are caused by an overactive immune system. When psoriasis is particularly severe, the inflammation causes internal problems. Psoriasis is associated with arthritis, heart disease and depression.

Psoriasis can help us better understand the costs in our health care system. A patient with relatively mild psoriasis (a few red, scaly spots on the elbows and knees) has several options for treatment, the first being a high-potency topical cortisone medication, which typically clears up the spots if the patient uses it regularly. The topical cortisone medicines are reasonably safe; however, with persistent long-term use, cortisone medicines can cause some thinning of the skin. 

  • The high potency topical corticosteroids have been around a long time. Generic versions are available in creams and ointments and can be purchased for only a few dollars a tube; however, they can be messy.
  • If patients prefer less mess, they can choose newer formulations of topical corticosteroids, including a spray or foam. These are easier to use but significantly more expensive, costing $100 to $200 per container.
  • Patients also have the option of a vitamin D cream or ointment. These drugs are considerably more expensive than generic topical cortisones, but have fewer long-term side effects. One company developed a combination cortisone/vitamin D ointment that contains both products. While this is a convenient way to get the benefit of both drugs at once, a large tube of the medication can cost $800 or more.

The newer options may perform better on a patient’s psoriasis than the first, but patients tend to choose the drug based on the type of insurance they have: 

  • If patients are uninsured, have no prescription benefit or have a high co-payment for medications, they will often choose one of the low cost, generic topical cortisone medications.
  • If patients have good prescription coverage as part of their insurance, they may choose a branded cortisone medication. I had one patient who had terrific drug coverage in their insurance plan. When offered the choice of a low-cost generic cortisone, the less messy/more costly high strength cortisone in the spray, and the highest cost combination cortisone/vitamin D medication, the patient said, “Doc, give me the spray and the combination drug. I’ll try them both and see which I like better. My insurance covers the cost of my medications.”

The cost of medical care doesn’t follow the rules of cost that apply to most consumer goods because the people who consume the medical care aren’t the ones directly paying for it. If well insured patients are given a choice between a $10 drug that may work reasonably well and a $10,000 drug that might work 10 percent better, the patient is quite likely to choose the $10,000 drug. That kind of thing doesn’t happen at a place like Best Buy. People won’t pay a 100 times higher price for a computer that offers just 10 percent more RAM or a camera that has 10 percent more pixels.

If people were paying for care out of their own pockets, they wouldn’t buy $50 aspirin pills in the hospital —they would pay for less expensive products that met their needs. They would search for the best deals on medical care. Providers of services would be forced to compete on price, and the price of health care services would drop, making care more affordable for everyone.

There are people who argue that medical care is inherently different from other services we purchase, that we need health insurance companies to make decisions for us and to pay for things that we can’t afford. Certainly the growth in the cost of health care is different from other goods, but much of the high cost is caused by health insurance, not solved by health insurance.

Yes, there are emergencies and complexities that make purchasing health care somewhat different from purchasing other products. But it isn’t completely different — there are non-health care emergencies and other incredibly complex products and services that we purchase regularly.

The difference is that when we buy those products with our money, our tendency to search out low prices and only pay for those things that are worth the price. 

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