February 15, 2008
FDA Proposes Lack-of-Evidence-Based Medicine Policy
The Food and Drug Administration today proposed giving drug industry detailers the right to hand physicians reprints of journal articles touting the off-label use of prescription drugs. The proposed guidance was immediately blasted by Rep. Henry Waxman (D-CA), chairman of the House Oversight and Reform Committee, who called it "terrible for the public health. It caters to the industry’s desire to market their products without adequate testing or review."
Last December, Waxman's staff uncovered minutes of a meeting between top FDA officials and Dan Troy (who was general counsel at FDA during President Bush's first term) and other drug industry lobbyists. The industry spokesmen "expressed concerns about Federal prosecutors pursuing distributors of (joumal reprints) for criminal misconduct," according to the minutes. "There is confusion about the rules, possibly an FDA guidance could clarify the rules."
Waxman demanded the agency hold off on issuing its guidance until Congress passed a law protecting physicians and the public from a new burst of off-labeling marketing that would surely result from liberalization of the rules. His efforts were backed by state attorneys general fighting to hold down costs in their Medicaid programs and trial lawyers suing drug companies over illegal marketing schemes (the use of journal reprints promoting off-label use was a major element in the Neurontin case).
So what was in today's proposed guidance? It pretty much gives industry everything it was looking for. It would allow drug salespersons to drop off article reprints as long as they came from a peer-reviewed journal that had a conflict-of-interest disclosure policy. Articles from industry-funded supplements would not be allowed.
The policy also said the reprint couldn't be marked up in any way to highlight specific points, and must include a copy of the approved FDA label for the drug or device. It also couldn't be accompanied by other promotional literature for the approved uses.
Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research. All the proposed guidance says is that the studies should be "adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training."
This is an open door for the drug industry to conduct more so-called seeding trials that encourage off-label uses. Because of their small size and lack of a control group, these trials are almost always of limited value in judging the true benefit of the drug in that off-label use.
Unfortunately, there are lots of second-tier journals in every medical specialty that publish dozens of such trials every year. And they will be happier than ever to take them since, should this guidance get adopted, they are likely to see reprint requests from drug companies soar.
Moreover, in exchange for the right to distribute literature on off-label uses, the company won't even have to pledge to submit an application to the FDA seeking approval for that off-label use. Not now, not three years from now, not ever.
As the nation grapples with how to pay for skyrocketing health care costs and policy wonks grapple with how to get more physicians to follow evidence-based medical practices, the Bush administration's FDA (the guidance was written by Randall Lutter, who was at the American Enterprise Institute before taking over the agency's policy shop) has proposed opening the floodgates to wider promotion and use of unproven drugs.
There's a name for that kind of policy: Lack-of-Evidence-Based Medicine.
Posted by gooznews at February 15, 2008 05:47 PMand he (Waxman) is wasting my tax dollars on HGH....aint that a bomber or an iceberg?
Posted by: rawdawgbuffalo at February 16, 2008 12:41 AMMerrill,
You are so Right!
Send this post in as a comment into the FDA.
We have 60 days to kill this terrible idea!
.
My guess - this is the last gasp idea if the Big Pharma moles inside the FDA and the PhRMA lobbyists in Congress
Ignored in the articles is the fact that most of the studies are corrupt products of industry funding. The peer review process never looks at raw data or CSRs which are summaries of study results submitted to the FDA. The published results often directly contradict the actual data and FDA assessments of the study results.
The FDA never corrects the public record because the CSRs are "confidential" and of course the FDA is incompetent and in the pocket of big Pharma.
Many if not most review articles are ghost written by contract organizations like STI.
The Vigor and Advantage trials of Vioxx which were corrupt appeared in the NEJM and Annals of Internal Medicine. The Celebrex fraud appeared in JAMA.
No journal looks at data; no journal even performs IRS like random audits. After the perps were exposed no investigation ensued. Not at the Universities, not by the US Attorneys and not by Congress or the FDA.
Posted by: david egilman at February 16, 2008 08:27 AMWell at least it's good to know that there's absolutely no encouragement by anyone in pharmaland for docs to prescribe off label now! Of course, this minor detail (ha ha) could change all that!
Posted by: Matthew Holt at February 16, 2008 10:07 AMI'd like to think that this isn't FDA acting on its own, but merely as an extension of the Executive.
Let's face it, the guiding mantra of The Right is less governement (unless, of course, it concerns what you are doing in the privacy of your own bedroom) and more free market.
I would hope that Mr. Waxman and other sensibile leaders in Congress view this one as DOA.
Posted by: Jeff Lazar at February 16, 2008 11:11 AMMerrill--
This is a very important story. Thanks for
throwing a spotlight on it.
Troy has done so much damage at the FDA.
Ten more months. And then, I know, you will keep the FDA in the spotlight. With the next administration, we should see a huge turn-around.
You know what you get for laundering research?
A Ph.D.. /rimshot
Seriously, off label marketing is not ok in any way, shape or form. I should not be able to market to doctors or eventually have commercials on TV that say my nasal spray is a treatment for E.D. without clinical trials that prove it is safe and effective. (Ask your doctor about Enzyte!- That's it the whole comercial, with Smiling Bob. *FDA approved Nasal Decongestant.*)
Big Pharma is becoming just like "Smiling Bob" you know from Enzyte... That penis enlargement Nasal Spray.
I blame the FDA's user-fee system for this. That made sense in 1992, but Congress has grown too reliant on the practice, which, in the words of Dr. Marcia Angell (a senior lecturer at Harvard Medical School) "In effect, the user fee act put the FDA on the payroll of the industry it regulates."
That may be true, but apparently, the FDA has forgotten that they are not there to serve the needs of the industries they regulate, they are there to ensure the nation's food, drugs, biopharmaceuticals and medical devices are safe. In recent years, we have seen an unraveling of the FDA's reputation for doing even that, ranging from e-coli infected spinach in our salad bowls, to problems with countless drugs, a lack of inspecting of suppliers, and everything else.
Considering these problems, it is inconceivable that this would be introduced NOW. What on earth are they thinking? Perhaps Andy Von Eschenbach should step down, as some are calling for!
Posted by: Scott at February 17, 2008 12:34 AMQuackery – The FDA Promotes Unproven Medicine For Profit
Editorial
“Like ghouls feasting on the bodies of the dead and the dying…” – Morris Fishbein, M.D., (1889 – 1976), editor of the Journal of the American Medical Association (JAMA) from 1924 to 1950.
The FDA is promoting quackery – unproven medicine for a profit. They have issued a “proposed guidance” which will allow drug dealers (Big Pharma) to hire drug pushers (detail men) to promote FDA drugs for use in unproven treatment.
What? Under the twisted logic of FDA and Big Pharma, their partners in crime, the FDA is now suggesting that it may be proper to allow drug pushers to promote drugs for unproven uses.
Why? Because billions of dollars hang in the balance. And the drug pushers have no interest in public safety if it interferes with their bottom line.
The FDA – in its present form – can not provide safe food.
The FDA – in its present form – can not provide safe drugs.
The FDA must be dismantled.
The Food Administration should be created with a “Citizens Advisory Board” in complete control. This will allow The Food Administration to act in the public interest instead of the interests of Big Food.
The Drug Administration should be created with a “Citizens Advisory Board” in complete control. This will allow The Drug Administration to act in the public interest – instead of the interests of Big Drug.
Stop the madness.
Take action.
The health and welfare of America hangs in the balance.
For the truth about unproven drugs and cancer contact…
People Against Cancer
Phone: 515-972-4444
Fax: 515-972-4415
Email: Info@PeopleAgainstCancer.com
Web: www.PeopleAgainstCancer.com
Jeff Lazar, you state: "Let's face it, the guiding mantra of The Right is less governement (unless, of course, it concerns what you are doing in the privacy of your own bedroom) and more free market."
We see agency after agency headed/run by what, to all appearances, is incompetent cronies. At first, I thought this was a case of poor judgment; I now think otherwise. If ALL government is 'missing in action', WE THE PEOPLE will demand less government . . . but we need to remember a couple of things. FIRST, we ARE the government . . . at least, without our tax dollars, there would be no government. If the current administration succeeds in disabling our economy, there may be no tax dollars to fund much of government (and you can bet the first to go will be important regulatory agencies). SECOND, less BAD government is STILL bad government. We need to end cronyism and revolving-door political appointments that ARE the current paradigm. And the only way we have to do this is with our votes (and prayers that they can be counted accurately).
Once upon a time, we had public servants who crusaded on behalf of WE THE PEOPLE. These sorts of individuals also seem to be missing in action; hopefully, they're just biding their time. But maybe they have been so overwhelmed with massive misconduct they have grown weary and abandoned the task.
If FDA caves on this latest pharma entitlement scheme, we will be forced to do battle with our healthcare providers in what may become "dueling science." When we express real concerns to our doctors and find we are 'educated' with industry-sponsored 'pseudo' scientific articles, offered in the interests of brevity and 'irrefutable scientific proof,' how can we remain involved in our own healthcare?
Posted by: Melody at February 17, 2008 06:14 PMThe stated justification for this new F.D.A. proposal – saving lives – is humbug and fear-mongering. A truly important new drug or new off-label application will sell itself through professional communication channels among physicians. The hubris of the pharmaceutical corporations in presuming to be the essential conduit of life-saving information is breathtaking.
The F.D.A. would require that the promotional off-label articles be peer-reviewed and come from a journal with an expert editorial board. This veneer of objectivity might sound good to the F.D.A. but it won’t fool anybody else. Pharmaceutical corporations have a long history of co-opting key opinion leaders (KOLs) in academic medicine to publish corporate infomercials in all the best journals. The corporations will even write the articles for the KOLs.
A detailed case study of the systematic deceits used by KOLs and corporations to promote off-label drug use by corrupting first-tier medical journals is available on the Health Care Renewal blog for 16 January 2008 (http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html ) and a companion case study of corruption in continuing medical education appeared on 22 January (http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html). The principal KOL in these cases, a member of the Institute of Medicine no less, has a long history of ethical controversy.
Thus, the safeguards the F.D.A. proposed for this new plan were broken long ago. All in all, this is a very, very bad idea.
Merrill, thanks so much for giving insight on this new policy that is trying to be enacted. As a policy major, I am appalled at the idea of a policy such as this one even being brought to the table. I cannot believe that anyone would really think that this would be beneficial for either physicians or patients. Not only does this pose a possible threat to patients, but it could potentially be more costly for physicians and even the pharmaceutical companies if these drugs prove to have adverse effects when using them for off-label purposes. I am curious to know if the people who would be put in these so-called clinical investigations are aware of what they are putting themselves through. Even if they did, you are correct in saying that the result of these studies could be misconstrued. Who can assure us that the proved benefits of taking a medicine are not the result of another confounding factor. It makes me very weary of where the FDA's heart really is if they are willing to propose something that could potential even take someone's life. While pharmaceutical companies might make more money rapidly, the long term effects and cost for the country cannot be measured. It is imperative that we keep the same type of test and trials that we have been doing in order to ensure knowledge of the true benefits of these drugs. I would hate to see so much money go to waste trying to recover from such a crisis that a policy like this poses.
Posted by: AIV at February 20, 2008 08:17 AM