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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.

May 10, 2000: Senator Byron Dorgan co-sponsors the following amendment:

“NONINTERFERENCE. — In administering the prescription drug benefit program established under this part, the Secretary may not — (1) require a particular formulary or institute a price structure for benefits; (2) interfere in any way with negotiations between private entities and drug manufacturers, or wholesalers; or (3) otherwise interfere with the competitive nature of providing a prescription drug benefit through private entities.”

Six years and 180 degrees later …

July 2006: Senator Byron Dorgan plans to offer the following amendment:

“REQUIREMENT TO NEGOTIATE PRICES WITH MANUFACTURERS. — In order to ensure that each Part D individual who is enrolled under a prescription drug plan or an MA-PD plan pays the lowest possible price for covered Part D drugs, the Secretary shall negotiate contracts with manufacturers of covered Part D drugs, consistent with the requirements of this part and in furtherance of the goals of providing quality health care and containing costs under this part.”

Yep — Senator Dorgan was for it before he was against it.

As Lord Byron wrote, “I’ll publish right or wrong. Fools are my theme, let satire be my song.”

Here are the facts behind the posturing:

The CMS chief actuary has already rejected the idea that Federal “interference” will save money:

“In considering these issues, we believe that direct price negotiation by the Secretary would be unlikely to achieve prescription drug discounts of greater magnitude than those negotiated by Medicare prescription drug plans responding to competitive forces.”

And the CBO has made a similar determination:

“We estimate that striking [the non-interference] provision would have a negligible effect on federal spending because CBO estimates that substantial savings will be obtained by the private plans and that the Secretary would not be able to negotiate prices that further reduce federal spending to a significant degree.”

The fact is that robust competition among Medicare Drug Plans continues to drive down costs for beneficiaries and taxpayers, while stimulating enrollment.

* According to CMS, the net total cost of the drug benefit to the federal government over the next decade is about 20% (or $180 billion) lower than the total cost estimated last year.

* The vast majority of this reduction is the result of lower-than-expected drug costs and higher-than-expected price breaks negotiated by Medicare drug plans. According to CMS, data from Part D plans demonstrate that rebates and discounts on drugs are much larger than originally projected.

When’s the last time a government-negotiated program delivered such numbers?

(Hint: Never.)

According to government experts, eliminating “noninterference” won’t save money, but it will lead to government price controls and a government controlled benefit.

CBO has found that multiple, competing private sector plans contain costs more effectively than a government-controlled benefit through competition and plans’ use of price discounts, rebates, and other tools. (Surprise! Everything you learned in Econ 101 was right.) The noninterference provision protects this approach by preventing government bureaucrats from getting in the way of these negotiations.

Repeal of the noninterference provision would also repeal the prohibition on the government setting a national, one-size fits all, formulary. Yikes!

According to CBO, allowing the government to negotiate prices may not result in current VA prices for Medicare Part D — The VA Health Care System is a public health system with statutory price controls and other special arrangements representing a very small share of the market.

For more on why VA is not a better way, please see my previous blog (“VA is not the way,” 3/13/06).

Bottom line? The Medicare Drug Benefit gives Medicare beneficiaries the same negotiating power that works for Members of Congress and 190 million other Americans.

Federal interference was a bad idea when Senator Dorgan was against it in 2000. And it is still a bad idea now that he is for it in 2006.

Competition works. Politics gets in the way.

To once again quote Lord Byron, “Always laugh when you can. It is cheap medicine.”

And, methinks, Lord outranks Senator.

NPR’s Joanne Silberner has an informative and compassionate look at the progress — so far — of the use of pharmacogenomics in improving drug prescribing in her broadcast today. The link to the podcast and excellent FAQ about personalized medicine is posted below. She, along with Cathy Arnst of Businessweek and Anne Underwood of Newsweek have provided solid coverage of this field.


  • 07.20.2006

Remember the Madonna video?

Vogue. Strike a pose.

That’s what’s behind the ill-considered and dangerous Vitter amendment that would neuter US Customs and Border Protection from actually protecting US citizens — by removing their authority to seize illegal, potentially unsafe and counterfeit prescription drugs that Americans import “from Canada.”

“From Canada?” Not necessarily.

All of the large Canadian internet pharmacies openly admit that the drugs they send to unsuspecting Americans are not “the same” drugs that Canadians get at their local pharmacy. They’re from other places — many from Europe. So what’s wrong with that? Two words — parallel trade — the term Europeans use for drug importation. Senator Vitter may only want drugs “from Canada” — but that’s impossible — because EU law makes it so. According to the Treaty of Rome, parallel trade is completely legal and Articles 30 and 36 prohibit manufacturers from managing their European supply chains in their own or patients’ interests.

Sorry Senator, the truth is inconvenient.

Last year 140 million individual drug packages were parallel imported throughout the European Union — and a secondary wholesaler repackaged each and every one. (The same type of secondary wholesaler that we are trying to eliminate in the US because of their role as “weak link in the chain” — the chain of custody that is.)

This means that, literally, parallel traders in Europe open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.

Vogue. Strike a pose.

This means that drugs purchased from a British pharmacy to an unknowing American consumer (or a blissfully ignorant United States Senator) could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by British pharmacies. In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.

Stubborn facts.

No time to Vogue.


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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