Latest Drugwonks' Blog
Consider the headline from this week's BioCentury on the new ESA label, "FDA the enforcer."
Authored by the thoughtful and no-nonsense Steve Usdin, the article calls the agency's action, "a dramatic example of how the FDA is willing to use its new powers ..."
And while this isn't a Clark-Kent-Fortress-of Solitude denouement, it is significant -- and as much for the obvious reasons as for some interesting unintended consequences.
The obvious conclusion is that label changes will happen with greater alacrity. An intended consequence of the FDAAA. On this issue, where you stand depends on where you sit. We think it's a good thing because it does away with delaying tactics that served more of a marketing purpose than a public health one. At the end of the day, intelligent people can disagree -- but it's the FDA's job to make the ultimate call.
A less obvious consequence is enhanced transparency in the label discussion process. Usdin writes:
"FDA has been unusually transparent about its interactions with Amgen over ESA labeling in the cancer setting. The agency has released correspondence with the company that describes labeling negotiations, detailed points of disagreement and explained its position in interviews with BioCentury and other news media, and posted redlined copies of the label that highlight changes."
We think that enhanced transparency is a good thing too.
Further, according to Usdin, "The disclosures suggest it would have taken longer to negotiate the changes, and the final language would have been different, in the absence of the new authorities."
Faster? Yes. Different? Maybe. But we now know who wanted what and why. And that's important.
Consider Amgen's statement:
"Amgen has worked closely with the FDA to develop the new label and has no plans to appeal. Although we may have disagreed on specific points, we are pleased that the final label permits physician discretion and recognizes the known benefit:risk profiles of ESAs at this time."
Well, so much for FDA being in the pocket of those it regulates.
We'll give Richard Pazdur the last word (because that's the way he likes it):
"This is a journey and we have not completed it."
(And he's worth listening to.)
See for yourself on our latest vidcast here.
Much hand wringing and speculation over the FDA’s recent Vanda decision. And the big question being asked is:
Is this the end of the dynamic duo of safety/efficacy and the beginning of a new Holy Trinity that includes comparative effectiveness?
Most reporting went something like this (courtesy of the Washington Post):
“Vanda Pharmaceuticals' stock tumbled 73 percent Monday after federal regulators rejected the
In fairness, the FDA didn’t actually say anything. This is how Vanda chose to represent the communications it received from the agency.
But rather than looking at this through the lens of comparative effectiveness – perhaps a better way to think about it is via comparative safety. Should inferior performance in some settings (for example if you won't know about it for weeks) be a molecule killer? The debate isn’t only (or primarily) whether it's bad to be worse – but also whether it can be easily monitored.
A tough situation for the FDA and a potential opportunity for those who would exploit this situation to call for a NICE-like system in the U.S. – such as Senators Baucus and Conrad and their “Comparative Effectiveness Research Act of 2008”
But it’s really just the latest example of why dogmatic approaches to drug regulation don’t work -- and why the Critical Path program is so essential.
Nobody said the FDA’s job was an easy one.
"The government could start paying impartial experts to visit doctors to talk about the safety, effectiveness and cost of prescription drugs and other treatments.
The idea would be to give presentations along the lines of those given by company drug reps. But the federally funded presentations would provide a counterweight to the industry messages on specific drugs.
A bill to that end is likely to be introduced today in both houses of Congress, according to the Prescription Project, a nonprofit that backs this sort of thing."
Impartial? Hardly. Right off the bat bias is built in...the government subsidized detailing will reduce drug costs..or else? Already a conflict of interest is introduced..the federal drug reps will be beholden to Senators Kohl, Grassley who have one objective...using detaiing to restrict the use of brand drugs.
And who will benefit? I noticed the Prescription Project supports the measure. No coincidence that Jerry Avorn who runs his own academic detailing company and contracts with state Medicaid agencies is an advisor to the Prescription Project, which in turn benefits from suing drug companies. And Avorn using ALLHAT as an example of conflict free prescribing. Problem is, ALLHAT undertreats most African Americans who have stroke.
This is beyond academic medicine rent seeking behavior as the previous post pointed out...this is a power grab that punishes patients. Worse, can you imagine have federal drug reps reporting on the who, what and where or what doctors are doing... Talk about a pharmaceutical police state..Don't like what docs are prescribing, call in DEA 2.0
A new study in the Journal of Public Health shows that German physicians have "a feeling" when evidence-based medicie is being used as a cost containment tool rather than a clinical tool to improve patient outcomes. The study also indicates that for certain disease states (i.e., diabetes) EBM may play a greater role than in others (i.e., CNS ).
Here’s the abstract:
The MHRA started investigating Mr Essadki in January 2006 after receiving information from Pfizer that customers had complained about two websites advertising Viagra and Cialis for sale. On March 2006 MHRA enforcement officers, accompanied by representatives from Pfizer and Eli Lilly together with the Metropolitan Police, went to Mr Essadki’s home address and found a quantity of Viagra and Cialis tablets. These were seized along with computers, mobile phones and a laptop.
Mick Deats, Group Manager of Enforcement at the MHRA said, “The MHRA will not hesitate to take action against those who undermine public health. There is considerable risk to the public from obtaining medicines through unregulated websites. A medicine bought in this way has no guarantee of safety, quality or effectiveness. It could be counterfeit. It may not contain the right amount of medicine. At worst it may cause a severe side effect."
First – the operation began in March 2006 – over two years ago.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
