Latest Drugwonks' Blog
"A drug company brings a new drug to market based on government-funded research. It charges a huge price for the drug, but since its the insurance companies money, it's everyone's money, which means it's no one's money. So no one complains -- for a while. What does Teva do with the huge cash flow that comes from selling this very expensive drug to a small population of MS sufferers? It funds clinical trials to show it's drug is superior to other in the field, which it shows, sort of. But the trials are never really good enough to prove superiority, just good enough to establish market dominance, which was probably the real goal of the trials. So the government has to sort things out, but it gets back into the game very late and very slowly. The insurance industry, fed up with paying extraordinarily high prices, starts putting the financial onus on patients."
www.gooznews.com/archives/cat_drugs.html
Goozner is referring to the Tier 4 payment category which by itself is crazy. But all of a sudden comparative clinical trials are no good. Maybe they should be bigger and government run. Then there would be no drugs except the one drug selected by government to hit the market. But wouldn't that create a monopoly price? No problem. In the Gooz's world. The price would be slashed by licensing out product to generic companies who would sell the rights to produce the breakthrough at pennies per dose.
Because innovation all flows from government anyways and all the R and D and the marketing and education carried out by private companies is sort of just greedy rent-seeking behavior of the basest sort... I would have no problem have a respectful debate on the best way to advance medical progress but Goozner and others want to shut off debate by attacking motives and funding sources. As I have noted, it cuts both ways but the media and the blogging world are intensely hypocritical on that score.
One other Goozworthy note...He claims I don't support embyronic stem cell research. He infers that because he asserts I am a conservative and CMPI is conservative and therefore assumes I hold down the line social conservative positions. In otherwords, Goozner who never bothered to check or ask me. For the record, I support ESC research though I have tremendous respect for the positions of those that do not and I don't write about it because it is not an area that is CMPI's central focus.
Doctors' protests are symptoms of a sick society
By Jacob Arfwedson
Corralling doctors has been an objective of French health policy for more than 20 years, with restricted entry to medical schools and financial incentives for early retirement.
The justification for such coercive guidelines around
Restricting access to doctors or treatments frequently results in costly invasive surgery, and/or longer hospital stays. Good healthcare inevitably means people live longer, which inevitably increases costs. But is the unspoken position of finance ministries that they would prefer citizens not to live so long?
Doctors and patients are increasingly weary of government-imposed healthcare management systems that lead to waiting lists and one-size-fits-all treatments. Many seek care abroad:
People value time and attention from doctors. In
Wrong-headed government attacks on standards are provoking protest among a profession with little natural inclination for going onto the streets. In
Two-thirds of German doctors resent the interference that limits them to a maximum of ten minutes for most patients and that penalises them for prescribing expensive drugs. More than half the German public reckon they are no longer getting the optimum treatment from their doctors.
Doctors’ protests are symptoms of a sick system. Healthcare should be viewed not as a burden but as an investment. Market-based provision and financing is the only way to turn healthcare into the growth industry it should be.
Doctors have yet to make their voices heard in the battle of ideas between the guardians of socialised medicine and proponents of a free healthcare market. The outcome will shape the fate of their patients and their own profession. They can ill afford to ignore the debate.
Jacob Arfwedson is director of the Centre for Medicine in the Public Interest in
To that end, CMPI (the public policy home of drugwonks.com) is pleased to offer a new omnibus overview of what the EU refers to as "Information to Patients" (ItP) -- "Who wants to know?"
"Who wants to know" is written by CMPI senior fellow Jacob Arfwedson. He's the chief of our Paris bureau. A Swede who speaks French and German and writes in English.
And he's controversial in any (and every) language.
To access "Who wants to know," go to www.cmpi.org and look under "research papers."
"In theory," because the meeting did address this issue -- but the majority of the time was spent discussing other things.
First up was supposed to be Kit Aikin to present the FDA's proposed study protocol -- but she was feeling under the weather and was replaced by the very capable (and very pregnant) Amy O'Donoghue.
Amy discussed the FDA's proposed research experiment (sampling, design, proposed stimuli, etc.) and the always fascinating Federal Paperwork Reduction Act. The latter because she needed to remind the committee about our fourth branch of government -- the Office of Management and Budget -- and how OMB regulations impact the general timing of the FDA rule-making process.
(When asked how long it could take to complete the rule making process, Kristin Davis of DDMAC commented, "You're looking at a couple of years." And this is after the 24 months the FDA has to complete the research study. One committee member was incensed and commented that Congress' intent was probably to delay the issue indefinitely and that something should be done about this OMB thing.)
BTW -- all the presentations, including the research protocol slides, can be found at www.regulations.gov. (reference docket FDA-2008-N-0226).
Some of the issues that came up:
* The use of the terms "adverse event" and "side effect" being used inter-changeably. Just what do consumers think they mean? The committee seemed to think that the FDA should look into this.
* How can poly-pharmacy patients report an adverse event when they can't be sure what's caused it?
* Will an 800 number (presented via a super, audio, or both) cause a "power of suggestion" situation, thus producing a kind of adverse event "placebo effect."
These general themes led the committee to worry (and rightfully so) that information reported via an 800 number would likely provide the FDA with data of questionable quality and utility. A serious "signal-to-noise" issue. Of particular worry was how the FDA would then use this information relative to communicating "early safety signals." Talk about unintended consequences!
* Speaking of FDA's use of information, it came out that DDMAC isn't looking at MEDWATCH reporting data. Explantation: they don't have the staff time to do the extra work. Bad excuse. Seemed to me, based on the response of the agency folks present, that this isn't something DDMAC's ever even thought about.
* Per how to best present an 800 number, there was general committee consensus that it would require both a super as well as audio. The "super-only" concept was shot down by one panelist who commented that "people aren't going to have pens and paper at the ready to copy down a number."
(Note to pharma physician detailers -- maybe a new use for pens.)
One committee member even suggested a "CNN-like crawl" that might run continuously during TV ads. (So now we're going to make risk information less distracting by making DTC ads more distracting?)
* Much discussion as well on how a regularly communicated 800 number would advance "the FDA brand" -- by showing that the agency is taking the lead not only in drug safety, but in safe use of medicines. Committee Chair Fischhoff commented that "the better the FDA brand, the better the industry brand."
Amen.
The concept of an FDA public service announcement on reporting adverse events/side effects was discussed at great length -- as well as how the agency might pay for production and get media placement. And there were a lot of "creative" ideas about the PSA. At this point, lots of people in the audience began picking at their blackberries.
* Much time also spent discussing the need to educate the American public that all drugs have both risks as well as benefits.
Where have I heard that before?
Here's the brief Reuters report of Day Two:
www.reuters.com/article/healthNews/idUSN1641693720080516
My favorite comment came from a note handed to me during the meeting that said, "Hmm, a 1-800 number for ED ads? I thought those would be 1-900 lines and cost $3.99 a minute."
As always -- where some see a problem others see opportunity.
vimeo.com/1020779
Speaking to an FDA advisory committee is one thing, speaking to the American public --the ultimate advisory committee -- is something else entirely.
(And the latter is more intimidating.)
Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER).
They all presented their terrific work. All the more so considering the shoe-string budgets under which they operate.
But what does any of this have to do with DTC and under-served communities?
Let's just say it's tangential.
But (and not surprisingly) it really caught the attention of the committee. Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep.
Danger, Will Robinson, danger.
Day One closed with "Committee Discussion." Some nutty. Some really useful.
Some examples:
* A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts.
* The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA"). Good idea.
* A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry.
Yes, industry.
A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea.
* And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced." And my other favorite, that DDMAC should pre-review "media placements."
At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information.
Onwards to Day Two and a stimulating conversation on 800 numbers for television ads.
In closing, I urged the committee to ponder this question posed by T.S. Eliot:
"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information?
Is anybody listening?
Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary."
The recommendations of the committee -- more research.
Very helpful.
This hearing is beginning to be like treading water in treacle.
Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket). He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck."
I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future.
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.
