Grand Rounds: “Communicating the Benefits and Harms of Prescriptions Drugs”

December 19, 2007

Bellevue AmphitheaterCommentary by Puja Korabathina PGY-3

This week’s medicine Grand Rounds was presented by Drs. Steven Woloshin and Lisa Schwartz , both alumni of NYU’s residency program who are currently performing research and practicing medicine at the Department of Medicine at Dartmouth Medical School. During their years of residency at Bellevue, they became interested in understanding the elements of and barriers to patient-doctor communication. Their current area of research — communicating the risks of prescription drug benefits in an accurate and thoughtful manner — is an extension of this original interest.

Patients make good decisions based on a combination of facts and values. How these facts are presented is a key message of this talk. Currently, the dense, scientifically written information about a particular drug printed in tiny font in the package insert is not amenable for the consumer to understand. Rather, pharmaceutical companies spent $5.2 billion in 2006 in direct-to-consumer advertising focusing on celebrity attestations and fancy diagrams. (Amazingly, this figure was ten times more than was spent in direct-to-doctor advertising in medical journals!) Interestingly, the FDA is not required by law to review the drug information that is presented to the public. Dr. Woloshin mentioned the abundance of clinical information and its accessibility to the public via the FDA’s website  (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm). While abundant and accessible, the material is poorly organized and dense and difficult to quickly glean key facts. Ultimately it is via negotiation between the FDA and a pharmaceutical company that a small portion of this information is extracted and presented to the public in the form of a “drug label.” Overall, important information may be lost by the time it gets to doctors and patients – especially, data on how well drugs work.

After years of frustration, Drs. Woloshin and Schwartz were inspired by a box of Cocoa puffs. Similar to a table of nutritional contents easily displayed on the side panel, they created a “drug facts box.” The box is organized into a descriptive section, a data table with efficacy and side effect data and a safety warning about new drugs. They have conducted studies showing that consumers like and understand the box. Most recently, in a national study, they showed that people who were shown the “drug box” (vs a standard direct-to-consumer ad) were more likely to choose the more effective heartburn drug: 71% vs 9% chose the proton pump inhibitor as much more effective than the H2 blocker. Drs. Woloshin and Schwartz are hopeful that their concept of the drug box will be become more widespread (in collaboration with the FDA) and will improve communication about how well drugs work. Below is a sample of this drug box:

 

Prescription Drug Facts: LUNESTA (eszopiclone)
What is this drug for? To make it easier to fall or to stay asleep
Who might consider taking it? Adults age 18 and older with insomnia for at least 1 month
Who should NOT take it? People under age 18
Recommended testing No blood tests, watch out for abnormal behavior
Other things to consider doing Reducing caffeine  (especially at night), exercise regular bedtime, avoid daytime naps
LUNESTA Study Findings

 

788 healthy adults with insomnia for at least 1 month — sleeping less than 6.5 hours per night and/or taking more than 30 minutes to fall asleep– were given LUNESTA or a sugar pill nightly for 6 months.   Here’s what happened:

 

What difference did LUNESTA make? People given

a sugar pill

 

People given

LUNESTA

(3 mg each night)

Did LUNESTA help?    
LUNESTA users fell asleep faster (15 minutes faster) 45 minutes

to fall asleep

30 minutes

to fall asleep

LUNESTA users slept longer (37 minutes longer) 5 hours

45 minutes

6 hours

22 minutes

Did LUNESTA have side effects?    
Life threatening side effectsNo difference between LUNESTA and a sugar pill  

None observed

Symptom side effects
More had unpleasant taste in their mouth   (additional 20% due to drug) 6%

6 in 100

26%

26 in 100

More had dizziness   (additional 7% due to drug) 3%

3 in 100

10%

10 in 100

More had drowsiness    (additional 6% due to drug) 3%

3 in 100

9%

9 in 100

More had dry mouth    (additional 5% due to drug) 2%

2 in 100

7%

7 in 100

More had nausea     (additional 5% due to drug) 6%

6 in 100

11%

11 in 100

How long has the drug been in use? Lunesta was approved by FDA in 2005.  As with all new drugs we simply don’t know how its safety record will hold up over time.  In general, if there are unforeseen, serious drug side effects, they emerge AFTER FDA approval (when a large enough number of people have used the drug).

One Response to Grand Rounds: “Communicating the Benefits and Harms of Prescriptions Drugs”

  1. Dan on June 1, 2008 at 9:48 pm

    The Benefits of Generic Medications: Is the Efficacy There?

    More now than in the past, generic medications have been encouraged by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable. Branded meds are still prescribed often, though, mainly due to samples of such meds provided at a doctor’s office from the sales reps who promote these meds. Generics typically are not sampled due to lack of funds compared with branded pharmaceutical companies. Yet generics cost a small fraction, such as a third of the cost, of the same branded meds that have the same molecular bioequivalence. Yet not all branded meds have a generic formulation due to patent exclusivity and therefore cannot be produced until the expiration of this patent of the branded med. This is further complicated by possibly a degree of apathy with health care providers, who appear largely demoralized with aspects of the U.S. Health Care System. More likely, however, is that samples do, in fact, help out the patients.
    Not long ago, generic meds were not prescribed that often, or produced to a great degree because of the cost of bringing such a med to the market, which at the time required the same protocols as branded meds. Fast forward to 1984, when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else included in the approval process. The reduced cost of generic production allowed for more of these meds to saturate the market, and doctors started prescribing more generic meds as a result. Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds, through such tactics as reformulation, which is called Evergreening, of their meds and frivolous patent infringement lawsuits, which delay generic availability for a longer period. Yet pharmacies support generic use, as they make more money off of generics compared with branded meds. So delays will not prevent the utilization of generics, overall. Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics.
    Also, other reasons for increased generic prescribing is due to the awareness and clinical experience of the previous branded med that has been replicated by the generic med. Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known med creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. It should be available to all health care providers for their access.
    Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers. Knowledge is a good thing.
    Yet some doctors insist that you get what you pay for, so they are convinced that branded meds are always more efficacious and tolerable than generic meds. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. Yet there may be some truth to decreased efficacy of generic meds over their branded equivalents.
    Considering the health care crisis in our country and the over-priced treatment methods in our system, as with branded pharmaceuticals, generic medications should be considered when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of this pharmaceutical system and request generics when being prescribed a med by their health care provider. In other words, they should question authority figures such as doctors are perceived to be, as patients definitely have a right to acquire knowledge and use this for their benefit with situations as their choices for treatment options, as this will be for their financial benefits while improving their well-being with generic medications- an ideal way to reduce health care costs and improve compliance with their meds because generics are an affordable asset to public health.

    “What good fortune for those in power that the people do not think.” — Adolph Hitler

    Dan Abshear

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