FDA”s ‘Know the Label’ campaign is nice, but does it really help patients?

The FDA has announced a new program to help doctors check the approved indications and other information in drug “labels.”  These “labels” are the FDA-approved educational information sheets that drug companies package with medication. See information below:

Online Service Enables Physicians To Check FDA-Approved Medication Labeling Via EHRs.

Healthcare IT News (1/27, Merrill) reported that to “boost drug safety, a new online service has been launched that allows doctors to check the FDA -approved labeling for the most commonly prescribed drugs.” The service is part “of a new campaign” called “Know the Label,” which is being “launched in concert with the FDA’s efforts to provide up-to-date and complete prescribing information to physicians.” It is being delivered to all US physicians and providers “electronically via the websites of PDR Network, The Doctors Company and other liability carriers, via EHR systems. … ‘We congratulate The Doctors Company and PDR Network for finding a practical and novel way for physicians to access the full updated labeling through electronic means and have it available at the point of prescribing,'” said Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research.

I doubt this new program to disseminate the label information is going to help patients much.  At least in my field, use of medication is based on  patients’ individual conditions and results of studies that go far beyond what’s in the FDA-approved “label.”  Medications are used for conditions other than FDA-approved uses.  Different doses are used.  Combinations that the FDA-approved label says are bad may often be exactly what a patient needs. I guess it won’t hurt to give doctors the information on FDA-approved medication labeling, unless it discourages doctors from giving patients needed treatments for unapproved conditions.

For best results, a doctor’s  good judgment is the best guide to treatment.

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Why can we trust new drugs? Pharma experts tell us on Getting Better Health Care

Clinical trials bring us the new wonder drugs that would have been considered either magical or miraculous in earlier times. Are you interested in how drugs are tested to assure efficacy and safety?

On two episodes of Getting Better Health Care, clinical researcher Bea Abrams, PhD, with over 30 years experience in pharmaceutical development, explains the process of clinical trials done to bring a new drug to market.  She shares with us critical information that lets us know how much we can trust new drugs and what to look out for.

In a subsequent episode, I’ll be talking with Dr. Lawrence Friedhoff — author of the book, New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients — about myths that surround new drug development.

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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)

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

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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Your smart pill is watching you?!

Reuters reported that the drug company Novartis has developed a chip-in-pill technology that can record when patients take their medication.  This is amazing and, well, a little bit chilling.  The idea in this case is to help make sure people who have had a transplant take the immunosuppressive medication they need to assure that they don’t reject the transplanted organ.

Poor use of medication is way too common.  Much of my research has been on how poorly patients with skin disease use their medicine and what can be done to help patients use their medications better.

Chips-in-pills that are activated by stomach acid is an interesting, “Star Wars” approach that could appeal to some people. And it shows the efforts that the health care system has to go to in order to get patients to use their medications well — which highlights the extent of this intractable problem.

But one  thing that I have found in my research is that making sure patients are satisfied with their care and trusting of their doctors — through the use of patient satisfaction feedback like we do at DrScore.com — is one of the (low-cost) ways to improve medication use.   I’m pretty sure that we could help improve patients’ care more by helping them better use available, low cost medications than by developing new, high cost medications and taking the Star Wars approach to making sure they use it.

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Pay for delay is not right for generics

Apparently there are senators from both parties seeking to remove a ban on generic drug settlements from an upcoming appropriations bill. The proposal would stop brand-name drug makers from making deals with generic manufacturers to keep generics off the market.

I’m not sure why we would need such legislation. That kind of deal sounds like the kind of collusion that should be impermissible under competition/anti-trust law.

Here are some of my other blogs on generic drugs:

It’s unfair to keep generics off the market

Pay for delay in generic drugs isn’t good for the patient

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Whether it’s TSA or medicine, transparency is a good thing

NPR reports that Congressman John Mica has been pushing to replace TSA airport screening employees with screeners from private companies, and that those companies have been major contributors to Congressman Mica.  Maybe replacing TSA employees with private screeners is a good idea, maybe it isn’t.  But do we trust the opinion of a Congressman who is taking money from the companies that would benefit from this policy?  Doesn’t that money make us question his judgment on this issue?

The reason I ask has nothing to do with airport screening.  The doubt that I feel when I hear this Congressman pushing policies that help the people who give him money makes we wonder if this is how some patients feel about the advice they get from their doctor — knowing the doctor received money for services provided to drug companies.

There are growing regulations at many levels on the relationship between health care providers and drug companies.  There is also greater transparency as drug companies start reporting what they give doctors. Transparency is a good thing.

It’s too bad that when it comes to politicians, it seems we are moving in the other direction — more money and less transparency.

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Politics at the FDA?

The Washington Post reports that the FDA may try to recall a device that was approved for repairing damaged knee joints.  The report says that the device was originally approved with little testing under rules that allow fast-track approval for products that are similar to other products already on the market.

Apparently FDA scientists thought more testing needed to be done, but the product was approved because of political pressure.

The FDA has a tough job.  It has to assure the efficacy and safety of new drugs and medical devices.  But there’s no way to show that anything is completely safe.  There has to be a balance between assuring safety and making products available to help patients in need.

I don’t know how much need there was for this knee joint replacement product.  It may be that getting it to market quickly helped far more people than it hurt.  Ideally, though, it would be good if objective decisions about benefits and risks could be made without political interference.  But it’s also important that the folks at the FDA not be allowed to spend too much time and resources assuring safety if in doing so they block patients’ access to helpful new treatments.

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The efficiency of electronic prescribing

More doctors are using electronic prescribing.  I am.  It’s cool that the prescription goes straight to the pharmacy, perhaps ready for the patient by the time the patient arrives at the pharmacy.  And no more worries about bad handwriting (instead, we’ll have worries about hitting the wrong button).

I imagine the prescription pad will soon find a place next to slide rules and dial telephones among what our kids regard as old relics and antiques.

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The joys of electronic records

Each day brings new joys from the electronic medical record system.  Being able to pull up graphs of patients’ laboratory results makes it so easy to assure that patients aren’t having a serious reaction to medication.  Doing refills is a snap — no more writing out prescriptions — just a couple of clicks, and it is done.  Checking for drug interactions and allergies is automatic.

And I don’t know if it is all that advantageous, but it is certainly cool to click “Send Electronically” and know that prescription will probably be ready at the pharmacy by the time the patient gets there.

We talk more about the use of electronic medical records to improve health care on my radio program, Getting Better Health Care.

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