FDA Review Info Unavailable For Popular Drugs
23 CommentsBy Ed Silverman // January 8th, 2010 // 9:03 am
A review found that safety and effectiveness info analyzed as part of the drug approval process isn’t available on the FDA web site for nine of the top 25 prescribed brand name drugs in the US, such as Lipitor, Plavix, and Synthroid. Of those reviews that are online, most were approved after 1997. The review was conducted by the Sunlight Foundation.
The agency site makes drug approval background documents available online only for drugs that were approved from 1998 on. Some info for drugs approved in 1997 or earlier is online, but only if someone made a Freedom of Information Act (FOIA) request. But in some cases the agency does not plan to post older info online because documents are in poor quality, the foundation reports.
Why does this matter? The background documents contain studies analyzed by the FDA, some of which may not be published in journals read by physicians for clues to patient treatment. This can be problematic. For instance, a study published last year in the New England Journal of Medicine analyzed data in FDA documents for 12 antidepressants and found several don’t work as well as literature published in journals suggests. Of 71 FDA-registered studies surveyed, 31 percent were never published, including 22 studies showing results the FDA had deemed negative or questionable (some background).
patrons99
Bravo! Kudos to the Sunlight Foundation. Sunshine is the best disinfectant. FOIA requests can take years. Some might say that they are actually “stonewalled”.
Ex-FDAer
It’s worse than that.
Over the past several years documents relating to safety of certain drugs used in ADHD have disappeared from the FDA files.
patrons99
Ex-FDAer:
Wow! Sounds like willful malfeasance at FDA. Who would ever have thought? Can you prove that? Who regulates the regulators? Why don’t you go public with that? Lives are potentially at risk. Has someone at FDA made a decision that the risks are “acceptable” and that the public does not have a right to know. Does the FDA have a conflict of interest? Whose interest does FDA represent?
elmore
And all this in light of the new “transparency” the FDA is boasting about. If people are taking drugs approved by the FDA, they have a right to see the documents that led to the approval.
pharmavet
I was involved with putting together the NDA for Synthroid from 1997-2000 after FDA issued its 1997 directive requiring NDA’S for levothyroxine products. In this process we requested safety data on file with FDA through FOIA in order to be able to generate a complete safety package. When we finally received the package, it was an almost uninterpretable amalgamation of data that looked as if it had been cut and pasted together. My guess with some of these other drugs is not the lack of safety data but the lack of readily useable data.
FDA
Pharmavet
There’s a variety of reasons info isn’t available or isn’t in a useful format. Some discussion of this can be found in the minutes for the FDA transparency meetings.
In many cases recent safety data in reviews IS cut and pasted. (If you don’t look you won’t find anything.) Cut and pasting at the FDA is a nearly surefire way to get promoted. It’s referred to by FDA management as being supportive of the strategic plan. In contrast quality objective review is certain to bring intense scrutiny and excessive work just trying to defend your work.
Even when the information is relatively new (within the past 5 years) and does not have the problems that the FDA claims, you find that for certain drugs reviews are posted for certain supplemental indications and not for others for which the indications are politically more sensitive. For example some of the approvals for supplemental indications and other changes to atypical antipsychotics. In addition even when reviews are posted, information is often not discussed in the medical reviews that should have been.
In other cases I have found that information has been redacted when it clearly does not meet the criteria for redaction and instead it’s simply that FDA does not want people to realize that they gave passes to companies who simply didn’t perform adequate studies and so the information was apparently redacted to hide the fact that necessary information was not submitted. (This I can prove as other information that was not redacted clearly indicates this.)
Even so there’s a ton of extremely useful information in publicly available FDA reviews that I’m certain the FDA wishes weren’t public.
patrons99
Even when faced with the facts, FDA rarely, if ever, withdraws an approved drug from the marketplace. This statistic alone (numbers of drugs withdrawn), makes it appear as though there is no drug safety crisis in this country.
Justice in MI
This is simply outrageous.
I essentially got started in this area because of what I found on the CDER site–studies that clearly showed a drug’s marketing materials to be misleading and/or outright lies. It wasn’t easy–you have to keep opening documents until you find what you’re after. And lots of pages blanked out. But the key stuff was there.
This was a drug approved before 1998, so I don’t know why the stuff was still there. But I’m sure glad it was, as were a number of docs with whom I shared it.
Justice in MI
An update related to FDAers comments about materials disappearing. I was wrong about dates. The relevant drug was approved in 2000. The link that used to go to the approval package now goes nowhere. The materials are not on line.
When they were, however, I made copies.
don
thanks for the posting.
sounds like this will be more newsworthy than only posting on a blog. I will look around for more articles on the FDA.
JaT
What we all need to realize is that the science of drug making can only really be confirmed by the reactions of the population. If those reactions are ignored or dismissed then that science loses credibility. It becomes unfinished.
JaT
We found info in Neurology Magazine (archived issues) for comparisons, a graph search on Google Images, The VA.
The info IS there. Older information is better because it is less likely to have been altered. Just don’t be surprised if the current info doesn’t match.
Elaine
FYI — In June 09, without notice even to FDA’s own employees, the website for FDA went down to be entirely revamped — with links to old site not working — cast to the wind? If you had links to FDA for referencing or a research project for example, you were out of luck.
JaT
I noticed that too, Elaine. Had to search again for information as it was all moved. Much harder to find the items. Some had been “updated”. Don’t believe it was an accident that original dates were replaced with the dates of the updates. At least I couldn’t find the original dates on them anymore. Maybe I just missed it. Timelines being of vital importance…
Elaine
Some of what we were working on was replaced with acknowledgement (like it was a good thing?) that the newly linked info was written with the help of the manufacturer. Oh my.
patrons99
Sounds a lot like evidence tampering, doesn’t it? It should be a federal crime. Motive, means, and opportunity. Probably even an agreement. Perhaps, one of the attorneys amongst us might care to comment.
JaT
For awhile we were reclaiming information that was cached. Those cached pages are pretty much gone but you might want to look into it.
Steve
I just have to say I really hate this new font you’re using.
bill inpa
fda is a joke
Justice in MI
The problem with dissing the FDA is that it ends up supporting those mainly responsible: Congress that continues to underfund and underpower; Administrations that politicize the agency; and the various forms of regulatory take-over we’ve seen.
Yes, FDA has its own courtiers, and cowards. But, at core, dissing FDA is like blaming the door because a rapist walked through it.
patrons99
Justice in MI: Well said! It’s probably wrong to broad brush diss the entire FDA. There are some VERY competent people there, who have a conscience, e.g. David Graham. It’s the system that needs repair. FDA Advisory meetings are really nothing more than “kangaroo courts” wherein the real decisions have already been made. There’s a revolving door policy between FDA and pharma. There’s currently a drug safety crisis in this country. Pharma owns most of the blame. FDA owns some of the blame. It will require legislative reform to fix all of the ills in the current system (drug development and drug marketing). Regretably, pharma’s influence ($$$) is pervasive.
pharmavet
I find it ironic that FDA has given itself new powers to order companies to make changes to their safety labeling, while at the same time their antediluvian computer systems makes this a bark with no bite. This is one case where FDA should get a waiver to spend the money earmarked for this purpose on hiring exper outside private contractors to integrate its far-flung computer systems. Instead, the work will go to the lowest bidder, and once again the government will be penny-wise and pound foolish.
M. Black
Didn’t Barry O’s first week in office include an Executive Memorandum DIRECTLY related to FOIA and his promise to light a fire under the heiny of the Attorney General to get rid of hold ups, and guilty-as-they-sound FDA officials pulling that “uuh, uuh, that’s confidential” bill$hit???
Could we replace our Attorney General with Beavis or Butthead? Please???