Dartmouth Medical School Professors & consumer watchdogs, Dr. Lisa Schwartz & Dr. Steve Woloshin
"FDA approval does not mean that a drug works well. It means only that the agency deemed its benefits to outweigh its harms."
"Much critical information that the FDA has at the time of approval may fail to make its way into the drug label and relevant journal articles."
--Drs. Woloshin & Schwartz, "Lost in Transmission--the FDA Drug Information That Never Reaches Clinicians" New England Journal of Medicine 361(18):1717, Oct. 29, 2009--
"To market a medication, all you have to do is prove that it's better, on average, than a sugar pill. A drug that works 20% of the time, for instance, may be considered effective--even though it does nothing for 80% of patients."
--Mark Gibson, deputy director of the Center for Evidence-Based Policy at Oregon Health & Sciences University--
Call me naive. I just assumed that when I took a prescription drug it was going to do the job it was approved to do--at least 80% of the time. I didn't know that FDA approval sometimes only means the benefits outweigh the harms.
Call me naive. I just assumed that my doctors clearly knew the effectiveness of the drugs they were prescribing. I didn't know that sometimes critical information on harmful effects, and a drug's effectiveness might never be communicated to doctors.
I definitely had a lot to learn. After reading Dr. Steve Woloshin's and Dr. Lisa M. Schwartz's article, "Lost in Transmission--FDA Drug Information that Never Reaches Clinicians" (NEJM 361(18):1717, Oct. 29, 2009) I will never take a drug's effectiveness and safety profile for granted again. Click here for the article.
Schwartz & Woloshin argue that the FDA needs to communicate clear-easy-to-understand drug information on every prescription label:
- How effective was the drug in research trials? Let's see the statistics.
- What are the harms of this drug? What are the benefits?
- What were the concerns of the experts who reviewed the drug? Let's see them.
- They want the FDA to write the drug labels and include complete information. Currently, the labels are written by the drug companies--and critical information is sometimes left out--as you'll see below.
- The drug companies have a vested interest in their products--they shouldn't be writing the labels.
- Schwartz & Woloshin want the FDA to provide a standardized Prescription Drug Facts Box on every drug label--with a data table of benefits and harms.
This super watchdog duo, who teach at The Dartmouth Institute for Health Policy and Clinical Practice, scoured the FDA's extensive drug reviews for three particular drugs in order to figure out what important information never made its way to the drug label, and into physicians' hands:
- Lunesta--the sleeping drug approved for chronic insomnia--the floating moth ads
- Rozerem--the sleeping drug approved for chronic insomnia--the weird Abraham Lincoln ads
- Zometa--a drug prescribed for abnormal calcium in the blood of some cancer patients
Hidden away in lengthy review documents--that can be anywhere from 80-400 pages long--is all the information that expert FDA reviewers compile about each drug during the lengthy evaluation process.
In these documents you can find all the statistics on how well the drug actually works--what are the risks & side effects--as well as what concerns the reviewers have about approving this drug.
But, remember, as long as a drug's benefits outweigh its risks, it can get approved.
Once it's approved, the pharmaceutical industry writes the labels, although the FDA can negotiate & approve the label.
The Problem: the drug label often omits critical information that never makes its way into journal articles, or into the hands of clinicians.
It could be because the drug industry can decide what it "wants" to go into the label. They want the drug to sell, after all.
1. It can leave out how well the drug did in trials against a placebo or another drug.
2. It can leave out certain mortality & risk data.
3. It can leave out the concerns or skepticism of the FDA expert reviewers.
Lunesta FDA Report Data That Do Not Appear in the Label
Lunesta sales reached $800 million last year, and there is no way for doctors, let alone patients, to know that this drug only helps you fall asleep 15 minutes faster, or sleep 37 minutes longer, than you would with a placebo.
There's no way to know that patients had no improvement in next-day alertness or functioning.
Would you be willing to risk side effects, no matter how minor, or pay for a prescription with this level of effectiveness?
Currently, there's no way for doctors to know from looking at the label which drugs the reviewers endorsed enthusiastically, and which ones they were skeptical about. Isn't it possible that because the drug industry is writing the labels, certain negative information might be left out of the labeling?
Rozerem FDA Report Data That Do Not Appear in the Label
Rozerem ads are all over the TV & print media. With an Abe Lincoln-type character in its ads, could there be a little Honest Abe subliminal messaging here?
Nowhere on the label is there information about how well Rozerem works. No wonder they left it out. For young adults, it helped you to fall asleep 14 minutes faster. Older adults fell asleep 7 minutes faster. This information would not be helpful to sales.
There were no subjective improvements in sleep time, sleep quality--nor did patients even feel like they fell asleep faster. No improvement in falling back asleep, number of awakenings, total sleep time, or sleep quality.
No one even noticed any benefits in two phase-3 outpatient trials.
And it gets worse. The medical review team leader said the team struggled about whether or not to approve this drug--whether it had any benefit at all. There were also several safety concerns because of side effects.
Nowhere on the label are the drug's lack of effectiveness, nor the reviewers' concerns communicated.
How Can You Access the FDA's Medical Reviews on Approved Drugs?
1. Go to Drugs@FDA. Click here.
2. Search for the drug you are interested in.
3. Select the correct drug.
4. Click on Approval History
5. Click on Review
6. Click on Medical Review. Then you'll get read the lengthy PDF with all the information from the expert reviewers.
Does the FDA Plan to Fix This Serious Truth-in-Labeling Problem?
- Sort of
- The FDA has recognized this labeling problem, and in 2006 it added a "highlights" section that emphasizes the drug's indications and warnings.
- The FDA has strongly "encouraged" the drug industry to include information on how effective the drug was in clinical trials--but the labels for Lunesta & Rozerem haven't changed.
- The FDA's Risk Advisory Committee has recommended adoption of clear "Prescription Drug Facts Boxes" that include a data table of benefits and harms.
- The FDA is now deciding whether or not to use these boxes--and if they should go on drug labels.
Thanks to Schwartz & Woloshin my eyes are now wide open when it comes to realizing how little we know about the actual benefits & risks of the prescription drugs we take. Next time I get a prescription (hopefully, that won't be anytime soon) I'm going straight to the FDA Medical Review document, and get the real scoop on what exactly I'm about to take.