Ask More, Listen Better

A new study in JAMA suggests that nearly one-in-three drugs approved by the FDA between 2001 and 2010 had post-market safety issues, which caused safety communications to physicians and consumers, "black-box" warnings on labels, and drug withdrawals.

It is not clear how many patients may have died or otherwise harmed by these issues.

Some complain the FDA takes too long to approve new drugs, but Kaiser Health News pointed out that the same Yale researchers had previously found that the FDA actually approves faster than European counterparts, and the study found that clinical trials typically involve less than 1,000 patients, and usually for less than six months.

Lead author Joseph Ross, M.D., noted: "No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals," and urged "that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively."

Dr. Eric Topol, who was not involved in the research, told the Washington Post that he was troubled but not surprised by the findings, and similarly suggested: "Why not have a standard where we put every new drug under watch, and see if we could catch a problem before the drug is widely advertised?"

Why not indeed?

In fact, why just new drugs, and why only drugs?

Take medical devices.  The FDA has a formal process for medical device reporting, which they say results in "several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions."

That sounds ominous.

Still, though, these reports require that the manufacturer report instances when their device "may have caused or contributed to a death or serious injury," which requires that someone -- a facility, a doctor, patient, etc -- tell them.  Of course, deciding what "caused or contributed" to a death or serious injury is probably as unclear as what entails a "serious injury."

Last year the FDA cited 12 hospitals for failing to report such issues, while also warning that "we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals."  Reporting by the actual patients and their families is voluntary, and most of us probably would not think of doing so in most circumstances.

Even worse, as Elizabeth Rosenthal profiled in An American Sickness, manufacturers can sometimes avoid FDA approval entirely, as happened with, for example, hip implants and surgical mesh.   Such problems may never be reported, or only after damaging enough patients that someone finally realizes there is a problem.

One has to believe more doesn't get reported than does.

This lack of ongoing oversight is a pervasive problem in our health care system.  Ever read those warning labels on drugs, which detail all the potential side effects?  Do they make you feel better, or worse?  Do they help you understand how likely you are to have them?

Chances are, none of the clinical trials had patients with your specific set of health issues or with your exact combination of other medications, so it's anyone's guess how you might respond to a drug, new or old.

More to the point, if you do suffer any side effects, what are you supposed to do?  You may just accept them.  Or perhaps tell your doctor, who maybe switches drugs, or maybe not.  In any event, probably no one is tracking or reporting the incidence of most such side effects.

This is not just a problem with drugs and devices.  Maybe you had a surgery.  If you ask your doctor before the surgery how back to "normal" you can expect to get, when, chances are he/she can't tell you -- and if he/she does, you'd be well-advised to question the source of those numbers.  There may be statistics on, say, how many patients get re-hospitalized and/or get an infection, but as to when you'll be walking without a limp, it's pretty subjective.

We track loads of "quality" metrics and conduct numerous patient satisfaction surveys, but not many people believe we're actually measuring quality, much less how a specific patient is doing today.  Nor do we have any firm idea what that patient should expect to feel like tomorrow.

Our mechanisms for tracking how patients are doing after we do something to them are minimal at best.  Physicians tend to rely on patients calling with any problems and on follow-up visits, but both leave lots of cracks to fall through -- and even they do not usually end up being recorded in any useful way.

This kind of "squeaky wheel" reporting is antiquated.  It comes from an age when it was hard to effectively track how people were dealing with their heath issues, and impossible to make sense of the mass of data that would be generated even if it was collected.

None of that is true now.

We have wearables.  We have online surveys.  We have medical device registries.  We have automated calls and texts.  We have patient review sites like Yelp (which may do better than formal surveys in tracking patient issues).  We'll soon have Internet of Things options that we can barely even imagine, from devices we won't even realize are there which are "listening" to us 24/7.

We should be able to track almost anything we wanted to about how a person is feeling, in real-time or near real-time.

No human could track all the data that will be generated, much less already-to-busy physicians.  That's OK; we have AIs that are becoming more and more able to sift through all this data and drawing meaning from it.  AIs could quantify the likelihood that you would get a side effect from a new drug, determine that you are suffering from a side effect from that drug, tell you when you should be able to walk how far after your knee implant.   They'll be able to alert your physician when something appears off.

Our current approach -- relying on someone to complain about problems -- is a way to uncover problems, but it is not nearly as effective as actively collecting and analyzing the data that would reveal the problems.  The good news is that we now can.  The bad new is that we are not.

We need to ask more, and listen better.