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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.
Any questions?
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?
By comparison:
* 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.
Liz Szaboé¾ article in USA Today (“Cancer care can sap a lifetime of savings”) mixes poor research and reporting to stretch one survivoré¾ pungent views about the price of cancer drugs into a conclusion that cancer drug prices are too high and should be controlled by the federal government. Corrections and context are in order. Szabo claims a study from the journal Cancer, published by the American Cancer Society, states that one in five cancer patients have delayed or missed treatments because of cost. That is untrue as written. The study found that delays or missed treatment were largely due to cost among cancer survivors who were uninsured, unemployed and low income. Thus the study refers to post treatment status where the cost issue deals with seeking physician care. And that is a function of coverage and income, not drug prices.
Ms. Szabo could have written a compelling article about the financial, emotional and physical challenges the survivor, Frank Beck, is facing after beating back late stage colon cancer. Instead, she makes it about the price of cancer drugs. Mr. Beck spent $12000 of his own money on various goods and services, no doubt on cancer drugs as well. Despite the fact that he had to pay a large chunk of the price of the drug out of pocket begs the question as to why he did not seek out help from the companies who make the medicine or why she regards a health plan that would require a cancer patient to pay a percentage of the price of anew cancer drug or cancer surgery to be “good” coverage.
Szabo implies the price of cancer drugs should be lower because the National Cancer Institute discovered or developed half of all cancer treatments in use. Again, not exactly the truth. The National Cancer Institute states that ité¾ involvement in early stage of development resulted in products which eventually were licensed to commercial organizations and reached the market. Thaté¾ something quite different. And it goes out of its way to note that drug development is largely carried out in the private sector and that most of the drugs it had a hand in are 20 years old. NCI spends $300 million on discovery and development. Thaté¾ less than one tenth of what companies and spend on the same activities. To suggest that taxpayers are paying twice for the same drug is nonsense in two respects. There is little overlap in the development plans because of failures, dropouts and different objectives. And in some instances the partnership is precisely what makes the medicine possible.
Finally, she holds up the Veterans Affairs drug-purchasing model as an example of how to reduce prices. She quotes Mr. Beck her case study as stating that the VA gets an automatic 24 percent discount But she fails to note prices are mandated by law to be 24 percent lower than the average manufacturer prices in the private sector or companies canç©° sell to Medicare or Medicaid. Thaté¾ price controls Whaté¾ more, the VA limits access to new drugs to keep costs down. Mr. Beck might be frustrated by the high price of the drugs he takes, Erbitux and Avastin perhaps among them for his late stage colon cancer. But he would be frustrated even more by the fact that in the VA system they are not on the formulary for use. Chances are he wouldnç©° be alive to tell his story to Szabo if the VA approach lauded for its price punishing power were in place.
I see that today’s USA Today has an article about an unfortunate soul with what appears to be terminal colon cancer, the treatment of which has “cost his health plan and family more than $150,000.” Like that NBA player some years back who combined with Michael Jordan for 68 points in a game—-Jordan scored 66 of them—-this patient has spent “more than $12,000 out-of-pocket,” a good part of which has been “for frequent trips to Oklahoma City and Houston to visit specialists,” out of that $150,000 plus. The article is vague in the extreme about the precise proportion of this patient’s care represented by drug therapies.
Well, anyway: This man is using insurance coverage precisely as it should be used in an efficient insurance market—-as protection against financial catastrophe rather than as pre-payment—-but somehow the article spends little time getting to the main point, to wit, the editorial about the evils of the pharmaceutical producers. The feds do not negotiate drug prices. The taxpayers subsidize Big Pharma through the NIH, and then have to pay high prices anyway. Prices for cancer drugs increased 22 percent in 2005, as compared with 3 percent for other drugs. And so on.
Excuse me, but does anyone at USA Today have a sense of what a drug costs when it is not available? In the article, the patient wonders if some additional months of life are worth all the costs—-this is a rare man indeed who cares so very deeply about his insurance company—-and his kids are unanimous in the affirmative. And so in the absence of the hundreds of millions of dollars spend by Genentech to develop Avastin, does USA Today believe that the resulting increased death rates and shorter lives ought to be viewed as “savings?” When an expensive drug is developed, the cost of the attendant improved treatment falls from infinite to something lower. Or relatively cheaper drug therapy is substituted for something else. Why is that a problem? This article is further evidence in support of the proposition that the public discussion of drug costs truly is appalling.
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