FDA Bureuacracy Is An Adverse Event
7 CommentsBy Ed Silverman // March 3rd, 2007 // 5:47 pm
No wonder the agency doesn’t know what’s going on.
It turns out the FDA wasted $25 million and lost four years trying to implement a new computer system to track side effects, frustrating safety officers who now lose about 45 minutes every day navigating a ‘dysfunctional’ system. Moreover, this pitiful assessment comes from a report the FDA itself commissioned - and then pressured the authors to deep six.
The situation is “frustrating and undermining…the post-marketing drug safety work” of FDA staff “because they lack some of the basic tools they need to perform their jobs, e.g. a computing system that meets their requirements,” says the report prepared by the Breckenridge Institute, a research and consulting firm.
The report blames a “lack of effective leadership and management” by the center’s Office of Information Technology, which mishandled the system upgrade through bureaucratic infighting, flawed planning and duplicative work performed by outside contractors. There was an internal tussle over a move to use off-the-shelf software that carried a one-time cost of $4.5 million and would have been up and running in 2005. A forthcoming system won’t be ready til 2009.
After the report was completed, the FDA asked the firm to delete much of it. “What they asked me to do was gut the report, and I refused to do it,” Mark Bodnarczuk, the Institute’s executive director, tells The Wall Street Journal (subscription required).
A document prepared by FDA officials in response to the report, which is marked as a draft, said it’s “riddled with editorial conclusions based on misleading or incorrect facts.” Doug Throckmorton, deputy director of the FDA’s drug center, says the firm was asked to extend its work, at no cost, which would have “given us an opportunity to talk about those misunderstandings, those inaccuracies.” Really? At no cost? What an offer.
If there’s any misunderstanding it’s this: Some FDA officials don’t seem to appreciate the extent to which the agency has lost the public’s confidence. And you don’t need a consulting firm to tell you that.
[tags]FDA, Side Effects[/tags]
Melody
In his book “Too Profitable to Cure, Hoadley says:
When a drug manufacturer covers up the flaws in a drug and submits information to government that is artfully skewed to diminish the flaws; when the FDA—that arm of the government meant to afford protection to the citizenry against unscrupulous behavior and dangerous drugs—refuses to give credence to the outcry of adverse events being reported to them; and when the politicians and reporters fail to do their jobs, whether from ignorance, self-aggrandizement or ennui, what is left of the government of the people, by the people, and for the people?
And he further states:
David Kessler (former head of FDA), in the Journal of the American Medical Association, noted the ADR system is entirely voluntary, with 90-99% of all ADRs never reported.
The ADR reports are usually not filled out completely and . . . there are thousands of highly-delineated classifications. Because of the large number of classifications, the likelihood that a single category will be impacted by numerous reports is minimized. For example, there are 160 terms for central nervous system reports. By dividing a large group of symptoms into many smaller categories, the pharmaceutical companies have been provided with a generous amount of “wiggle” room.
This system is so broken, I don’t know that even a first-rate computer system could provide a solution.
ed
Hi Melody,
You make a couple of very good points, which suggests a better computerized AE system has to reflect new thinking about classifying side effects. I haven’t seen what the system will offer, but if it’s not simpler, or somehow streamlined, it would certainly suggest the issue won’t go away.
The other point is, in some ways, more problematic. Many docs seem to avoid the paperwork because it’s time-consuming and, perhaps, fear liability. Perhaps there should be penalties for docs who don’t file AEs after being alerted by a patient, although the AMA will likely howl over liability. But I don’t know how else to insist docs participate in an important system. Any docs want to chime in, it would be welcomed.
ed
Melody
Ed–
The fact that doctors report only about 5% of the AE’s is not the only problem. Individuals who try to make a report are classified as “anecdtoal” and therefore, unmeaningful, inconsequential or downright stupid. Several diabetic acquaintances have tried, unsuccessfully, to report their “anecdotal” experiences. Doesn’t it seem the pinnacle of stupidity that if an event is not witnessed by a highly-educated or highly-trained healthcare expert, the value of the report is totally discredited. IOW, if you suffer an anaphylactic “episode” and are rushed to the hospital for life-saving intervention, the adverse event is purely anecdotal because the onset was not witnessed by “credible” experts.
Doctors do not want to get involved because there is follow-up paperwork–and the profession is already drowning in paperwork! The FDA’s present categorization is so arcane that “red flags” evidently don’t show up UNTIL the legal profession enters the picture with lawsuits–another bane of the medical profession. From a patient’s point of view, doctors want it both ways: by disregarding patient’s “anecdotal” messages, by not creating the needed paper trail, they can claim “they didn’t know.” And then they vocally cry FOUL when patients seek legal redress.
If you watch a video posted on the Diabetics International Forum (http://members.tripod.com/diabetics_world/) you can see how a pharma spokesman dismisses patients’ input. He says, in essense, “if they get a cold, they blame the insulin; if they sneeze, they blame the insulin. If they have a low blood sugar, they forget that they forgot to eat.) When the FDA allows this kind of faulty logic to impact their AE reporting criteria, it appears, to me, that the system is not only badly broken, but has little chance of being repaired.
ed
You make another good point, although, in very general terms, I can see both sides of the debate about what constitutes anecdotal.
Nonetheless, there is some irony to treating patient AE reports this way. The public is continuallly told to watch its collective health, and to so so, its best to be in tune with one’s body. Yet reporting specific changes is considered less than authoritative because specific medical training is lacking. The current approach does pose a conundrum, and would benefit from a re-think.
Laurie
“Some FDA officials don’t seem to appreciate the extent to which the agency has lost the public’s confidence.”
That’s the problem in a nutshell. The FDA still thinks that they are the gold standard, when in fact people have NO faith in their decision making abilities.
The current Adverse reaction reporting is sadly lacking, but even when stunningly simlar side effects are brought to the FDA in hearings, they still dismiss them. This isn’t all about an inadequate reporting system, this is about an FDA who’s focus has changed from their legistlative responsiblity. They are no longer effective….you can change the reporting system, but if the same people are still interpreting the data within the bias that they currently have, nothing will change.
ed
Hi Laurie,
So would a Democrat in the White House change anything? And, therefore, the potential for a new FDA commish with a, theoretically, different mandate?
ed
Laurie
It’s not a partisan thing, in my opinion. It’s about integrity, whoever is currently in control. It’s about chosing a head of the agency that has the ….guts, to say listen to the scientists, investigate the adverse reactions, pull a commericial that is misleading, and most importantly pull a bad drug quickly. Until the conflict of the same agency approving a drug being the one to pull a bad drug nothing will change.
Clinical trial investigation and FULL disclosure of ALL clinical trials being done is imperative The way it stand right now there are drugs being approved based on biased clinical trials. It’s a travesty to have drugs on the market for 10 years or more, and then we have black box warnings issued, based on information that was known to the FDA at approval.
The public didn’t sign up to be a huge clinical trial.
So, no it’s not about Democrat or Republican. It’s about honesty in all aspects of drug approval and tight oversight of clinical trials.