Latest Drugwonks' Blog
Andy was dandy today in front of the H.E.L.P. committee. If you’re into reading tea leaves, consider the fair and equitable demeanor of Senator Kennedy. What about the Murray/Clinton hold? It’s looking more self-serving and silly by the minute.
According to Leo Rosten in the Joys of Yiddish, a mensch (or mentch) is “someone to admire and emulate, someone of noble character. The key to being “a real mensch” is nothing less than character, rectitude, dignity, a sense of what is right, responsible, decorous.”
Some have carped that Andy von Eschenbach stirred the pot too much and broke too much china at his stint over at NCI. The same critics complained that as FDA commissioner he was too low key and spent too much of his limited time in pubilc simply saying the same things.
But if you are someone who has survived three forms of cancer your time horizon and your reaction to the cookie cutter criticisms of others can be quite different. You go at your own pace even as you are driven to complete a mission and engage others. You do it by not berating, bleating or browbeating. You are tough but you don’t show it by bulling others or throwing your weight around.
That’s a mensch and that’s Andy von Eschenbach. That was the person who testified in between long rants and howls that comprise the latest installment of the reality TV show, Hillary Knows Best, starring Sens. Hillary Clinton and Patty Murray. This week, as with last week and the week before and week before and week before and week before was an encore presentation of the show on Plan B and WHY THEIR HOLD ON THE FDA NOMINATION IS SAVING SCIENCE.
He was patient and concise, explaining to Senator Dodd why in an era when the science of drug development will allow us to determine that a drug most effective for a patient is also the safest we should seek to integrate safety and efficacy data, not chop it up into two agencie. (Dodd: “Yeah I understand that. But when a drug is on the market, shouldn’t a separate agency from the division that approved the drug pull it from the market….”) He invoked the Critical Path and the importance of transparency. But he also insisted that scientists who disagree with the consensus not claim that the majority is bought and sold or wrong and that they are right and do so by running to the media or some media-hungry Senator. He didn’t say that exactly. Rather he insisted on a standard of conduct, dignified, decorous and responsible. And he demonstrated that standard, behaving in stark contrast to many of the howling handful ho skewered him (Senator Kennedy being a dignified exception) and to those who have made book on counting out Andy in the past.
Andy von Mencshenbach….maybe he can change his name when he gets confirmed…
In a recent op-ed appearing in The Hill (“Medicare’s elephant in the room: The rising cost of pharmaceuticals”), Senator Jay Rockefeller has come out full-bore in favor of negating Federal non-interference for Medicare Part D. It’s chock full of errors. One example:
“In recent years, high-quality, affordable healthcare has eluded consumers, and the No. 1 culprit is skyrocketing prescription-drug costs.”
Nope. Imagine American health care spending as a dollar bill divided into a hundred pennies. How many pennies do you think represent spending on prescription drugs? 60? 80? Wrong. 10.5. The rest (otherwise known as 85%) represent everything else — from physician services (21.9%) to hospital care (31.3%). And, by the way, the 10.5% of US health care costs spent on Rx drugs includes both generics and on-patent pharmaceuticals.
What’s a better bargain: time spent in the hospital, or drugs that keep Americans healthy and productive? The answer is clear. Fewer cents make the most sense.
So why is this blog entry called “Rocky I?” Unfortunately it’s because I don’t think it’ll be my first and final comment on Senator Rockefeller’s newest issue.
Here is the response of Sens. Murry and Clinton on the news that Plan B might be available without an prescription to women 18 yrs and older:
“Today’s announcement is nothing more than another delay tactic. The FDA continues to shirk its duty to serve as an independent agency dedicated to no other goal than the promotion of sound science and the well-being of the American people,”
As Peter and I have asked before: Denying the FDA a permanent commissioner over Plan B advances the public health exactly how? Placing a hold on a FDA appointment because of condom labeling or having a Senate commitee review scientific decisions promotes sound science in what specific ways?
We look forward to the day when a member of congress places a hold on a nomination or pledges to boost FDA to dramatize the lack of effective treatments for Alzheimer’s or childhood cancers or taks a stroll over to HHS to thank FDA employees for approving a lifesaving treatment. Until then, the sounds of silence about how the FDA is shirking sound science from the Beltway blowhards would be a relief and might even reduce the oppresive humidty.
Like I said below — Letter B/Let it Be.
Here’s the headline:
FDA Announces Framework for Moving Emergency Contraception Medication to Over-the-Counter Status
And here’s the statement:
FDA announced today it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option. The Agency and the Sponsor will discuss the Sponsor’s proposed restricted distribution and risk management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older. FDA and the Sponsor have agreed to meet immediately to discuss the approvability of the Sponsor’s amended application and the framework by which this medicine can be made available over-the-counter. The Agency hopes that as both sides are committed to working diligently through these issues, the process can be wrapped up in a matter of weeks.
This decision is the result of a thoughtful and comprehensive scientific and public policy process undertaken by the Agency to resolve the novel and significant issues presented by the Sponsor’s amended application. Foremost in the Agency’s concerns is to establish a framework that strikes a balance between providing access to medicines considered safe and effective and ensuring the right policies are in place to promote their safe use. The Acting Commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step in moving the Agency’s broad and critical agenda forward.
One of things I miss about having kids under the age of 7 (mine are 19 and 15 so pray for me) is Sesame Street. I know, lots of “politically correct” issues, but even so it’s very educational and entertaining.
I especially liked the songs about the various letters of the alphabet. My favorite? “Letter B” sung to the tune of “Let it Be.” But I digress.
What I really want to talk about it the letter “D” — yes like in Part D.
“D,” in this context, does not and should not stand for “donut hole” — but that’s what the MSM thinks it means. What it actually stands for is “decision” — the decision to accept the responsibility for making smart health care choices. But that’s not a sexy news story and the media-savvy apostles proselytizing for Son of HillaryCare are doing a superb job feeding the frenzy with their anecdotes of woe.
Why are the anti Part D-ites focusing on the donut hole? Simple — because it paves the path for their ultimate message that “health care is complicated, so let Uncle Sam do all the work for you.”
Wrong! The consumer must be a partner in health care as well as health coverage — and not the junior partner either.
Those opting to focus on the donut hole today are the same people who, putting politics in front of the public health, worked tirelessly to frighten people away from signing up in the first place. One of their tactics was repeating the lie that there are no Part D insurance plans that provide for donut hole coverage.
Remember: “D” doesn’t stand for “donut hole”, it stands for “decisions” — and the right to have more than one.
Congratulations to Jeff Kindler on his elevation to the post of Chairman and CEO of Pfizer. We know Jeff and know him as a thoughtful person dedicated to the public health through a focus on medical research and development and smart public policy.
Good news for Pfizer. Good news for Pharma. Good news for the advancement of 21st century medicine.
The NYT’s Stephanie Saul hit another reporting low with her article on drug companies providing lunch to docs and their staff as part of their promotional pitch. For a minute, reading how all that pizza and Chinese food worked its way into the price of medicine, (probably half the price of the cost of Aricept right Stephanie) I thought it was a piece from the Onion. I mean, doctors who rely on the free food to pay for the lunch of staff because they can’t meet payroll and still get eggroll? Where did she find these people?
But then I realized she was serious, indeed in earnest. No dbout she was fed — pardon the pun — this story from the Soros funded group - No Free Lunch — a group of left wing docs who believe that physicians are corrupted by pens, coffee mugs and deli wraps.
So earnest that I guess she forgot to mention that the former BMS exmployee Kathleen Slattery-Moschkau she quotes extensively is also the writer-producer of a movie called “Side Effects” about her life as a sales rep. But I guess giving someone free publicity to promote their move without disclosing it even though that knowledge might shape your view of the article is ok while providing lunch to docs is unethical?
Let me add to Dr. Bob’s comments (see below).
As long ago as May 23 (gee whiz — a whole two months + three days ago), the anti Part-D-ites(aka: the gang that couldn’t enroll straight) was flacking a Commonwealth-sponsored study that claimed that 38% of those enrolled in Part D would fall into the abyss of the donut hole. Now that the generally accepted number is below 10%, I am shocked, just shocked that the headline in USA today read “More patients fall into a hole in drug benefit.”
Call me naive (my wife does), but I was sorta looking forward to something more like, “Initial estimates of donut hole victims cut by three-quarters.”
Dr. Bob asks why more of these folks (and in particular the folks profiled in the USA Today story) didn’t sign up for a policy that covered donut hole expenses. Part of the answer is that during the sign-up period, many pundits, pols, and special interest groups were actively peddling incorrect information about both the process and the various available plans. I did many radio call-in shows during the sign-up period, and I can attest that there was a lot of misinformation being purposely promulgated by those who wanted to hold down the volume of Part D enrollment.
One of these mistruths was that “there is no plan that will cover the donut hole.” And I heard it repeated again and again.
Shame. Shame. Shame.
But there is some sweet jelly in the middle of the donut. As USA Today did manage to report, “A USA TODAY/Gallup Poll in April, however, found voters by 2-to-1 were more likely to back members of Congress who voted for the prescription-drug law.”
I read the news today. Oh boy.
Here’s the most recent example of SchadenFDAude (noun. Pleasure derived from the misfortunes of the FDA) …
According to the Union for Concerned Scientists (UCS), FDA scientists are unhappy with the way the agency is doing business. But just who is UCS, what are they “concerned” about, and who are the unhappy FDA campers?
First UCS. Perhaps the best way to put into perspective this “unbiased” organization is to point out that their “fact sheet” (you should excuse the expression) uses the following as examples of “recent examples of abuses of science at the FDA” — Antidepressants, Vioxx, Plan B, and Ketek.
The grand slam of FDA-bashers. Unbiased? Nope. So, comment one — consider the source (which is more than the MSM did when reporting this story).
Second, who are the unhappy scientists at the FDA? Consider who filled out the UCS “research” instrument:
* 34% fewer than 5 years of FDA service
* 34% GS 9-12
* 34% Consumer Safety Officer
While the opinions of junior reviewers are certainly important, are their musings on what goes on at the highest levels of the FDA (or even within their own divisions) really relevant?
* 5% Commission Corp (USPHS)
* 2% Title 42 (Public Health Scientists)
(And perhaps the most telling statistic is that less than 17% even responded to the survey. Draw your own conclusions.)
So, pardon the bluntness, but the UCS study is more about junior staff not liking their junior opinions modified or corrected by the bosses. Not coincidentally, the percentage of “unhappy scientists” uncovered by this new “unbiased” study seems to generally fall into the thirty percent range.
Research is like a bikini. What it shows you is interesting, but what it conceals is essential.