Latest Drugwonks' Blog

The Letter "D"

  • 07.31.2006

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 Szabo龝 article in USA Today (“Cancer care can sap a lifetime of savings”) mixes poor research and reporting to stretch one survivor龝 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 it龝 involvement in early stage of development resulted in products which eventually were licensed to commercial organizations and reached the market. That龝 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. That龝 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 can穰 sell to Medicare or Medicaid. That龝 price controls What龝 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 wouldn穰 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.

Now is the time. Post your comments and support here.

I’ll bet all those pols and pundits who naively call for a “conflict-free code” for FDA advisory committee members don’t realize that such a zero-tolerance policy would lead to the destruction of the most open, transparent — and successful programs of clinical review in the world.

Consider Canada and Europe where advisory committees meet in secret, deliberating behind closed doors, commenting publicly only after they have reached a decision.

During my tenure at the FDA I was the senior official in charge of advisory committees. I recollect a meeting with officials from Health Canada — the FDA’s equivalent in Ottawa — who were aghast that our adcomm meetings were regularly attended by members of the media, financial analysts, patient groups, politicians — and that the meetings were recorded for public consumption.

I explained that such transparency was what made the meetings so valuable. At an FDA adcomm the agency is put to the test, to explain and defend its scientific thinking in public, before a panel of experts with the breadth and depth of experience to dissect the results, to challenge conclusions, and to make sure that no clinical stone goes unturned.

And the cornerstones of every adcomm are the clinical experts who serve on them. The best and the brightest our nation has to offer.

But Dr. Scott Gottlieb (the FDA’s Deputy Commissioner for Medical and Scientific Affairs) is worried (and rightfully so) that the value of these committee meetings could be eroded, “if current legislative proposals become law, and FDA is hampered in its ability to put experience and expertise as the paramount criteria when recruiting members to serve on these committees.” Gottlieb is concerned “by some who want appearance to trump acumen — who want the lack of private sector work to trump a plethora of scientific experience as a criterion when we are selecting who to put on our committees.”

In order to increase public confidence in the integrity of the advisory committee process, the FDA plans to take the following steps to help ensure advisory committees continue to be scientifically expert and independent and that the advisory committee process is transparent:

* Issue a guidance identifying more clearly the conditions under which conflict of interest waivers are granted. Currently, for example, waivers can be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities.

* Issue a guidance specifying when waivers of conflict of interest will be disclosed to the public and what information will be made available.

* Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available.

* Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee list serve and posting on the FDA web site.

* Implementation of a more streamlined approach to the appointment of members to the agency’s drug-related advisory committees.

At a panel discussion today on government-sponsored advisory committees organized by the Center for Science in the Public Interest (a group whose regular criticism of the agency makes Charles Grassley’s aureate prattle look meek by comparison), Gottlieb is expected to say that it “would be a significant step backwards if our primary criterion for selecting members to our committees becomes their lack of private sector work, if we exclude people for deep experience rather than embrace them for it. The public health will not be served if we’re no longer able to attract the kind of very active medical practitioners and clinical trialists who are able to inform our meetings with some very unique medical insights that only comes from years of experience both seeing patients and developing and looking at clinical data, sometimes in some very narrow fields or for specific indications.”

Yet pols and pundits continue to ask simplistic questiones, phrased more as accusations than inquiries. For example — “Why can’t the FDA just appoint panels with experts who don’t have conflicts and, therefore, won’t need waivers?”

It sounds good as a soundbite, but even a little homework shows the ignorance inherent in the question. FDA doesn’t appoint adcomm members meeting-by-meeting, case-by-case, action-by-action. FDA adcomms are standing committees, with members recruited and appointed sometimes years in advance, and who serve for defined terms of up to four years. And, according to Gottlieb, “This serves us well, since there is a value from having people who have institutional experience from serving on these committees. It is similar to the way the Senate works, where you don’t want all the members being brand new each year, or appointed just to vote on each individual issue.”

Gottlieb continues, “And this leads me to the heart of the problem: When we appoint these committee members, it is impossible to tell who is going to have relationships that could present the potential for an appearance of a conflict around a specific issue, and therefore require them to get a waiver, since we don’t know what issues are going to come up a year or two in advance. If we err on the side of caution, and only appoint members who have had absolutely no associations of any kind with any regulated products or industries, then we’re going to be hard pressed to find people that have also been engaged in relevant and unique scientific endeavors, since a lot of medical product research is done in collaboration, at least in part, with sponsors.”

“If we were prevented from being able to grant waivers in the first place, we’d have to recruit people who had no such associations, and were unlikely to develop them for the length of their tenure on our committees. I’m not only worried that such people would be very hard for us to find, especially since it’s sometimes not obvious to researchers themselves that their institution might have received a grant for research they had no involvement in, or a clinical trial they are working on might have received partial funding from a private source.”

Might we really pass legislation that bans the best and the brightest from serving the public health by disallowing their service on advisory committees because their preeminent expertise has also been viewed as valuable by the pharmaceutical industry?

Well, maybe not outright ban, but a codicil tucked in at the very end of the Enzi/Kennedy bill (page 98 for you really dedicated drugwonks out there) would make the process seem like persecution. The bill calls for the HHS Inspector General to review “on an on-going basis” the financial interests of a representative sample of individuals who have served on an FDA advisory committee.

I can attest, as a former senior FDA official, that it is very difficult to recruit the best and the brightest. This would make it almost impossible. After all, who would want to serve on an advisory committee when you’re viewed as a potential criminal before the ink on your appointment is even dry? Independent-thinking adcomm members will feel threatened and suffocated by the unspoken threat of federal investigators knocking at their clinic doors. Such legislation amounts to adcomm Lettres de Caches for folks like CSPI, posturing pols and Page One hungry reporters.

Ad captandum vulgus.

Our friend, Minnesota Governor Tim Pawlenty, just called pharmaceutical advertising “silly” and said that Congress should enact a two-year moratorium … if it would hold up in court.

Nice two-step Tim.

Coincidentally, Governor Pawlenty is in a tough reelection battle with Minnesota Attorney General Mike Hatch, author of the infamous 51-page, “Follow the Money: The Pharmaceutical Industry — The Other Drug Cartel.”

Silly? Only if getting more people to visit their physicians is silly. Silly? Only if earlier diagnosis of diabetes and heart disease is silly. Silly? Only if the distigmatization of depression and, yes, even erectile dysfunction, is silly.

Governor Tim also repeated the anti-pharma NewSpeak that drug ads raise drug prices. Sorry Gov — not so. When you compare all the drugs in any given therapeutic category, the ones that advertise the most do not always cost the most. In short, no correlation between ad spending and product cost.

To further flex the Governor’s pecs, Brian McClung, Pawlenty’s spokesman, noted that Pawlenty took on the White House early in the administration with a “first-in-the-nation” proposal to facilitate the buying of less expensive drugs in Canada.

But, according to the Minneapolis Star-Tribune, “… only about 18,000 prescriptions were ever obtained under the program, despite Pawlenty’s prediction that 700,000 Minnesotans would benefit.”

Silly indeed.

CMPI

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.

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