Last week the New York State Pharmacy and Therapeutics
Committee met to discuss adopting an evidence-based medicine approach to state reimbursement practices. Except that’s not what the proponents of the measure really want. What they really want is to ration health care in New York State. Evidence-based medicine, according to the definition, is “The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine requires the integration of individual clinical expertise with the best available external clinical evidence from systematic research and a patient’s unique values and circumstances.” Sounds good, right? Wrong. Because what was being presented in Albany was what’s known as “Rational Use of Drugs,” better known as “rationing of drugs.” It’s the same drivel that the eurocrats in Brussels and Geneva have been trying to sell for years to an EU citizenry sick and tired of long waits and poor outcomes. As David Sackett wrote in a 1996 article in the British Medical Journal, “Doctors practicing evidence-based medicine will identify and apply the most efficacious interventions to maximize the quality and quantity of life for individual patients; this may raise rather than lower the cost of their care.” As a particularly pithy bit of testimony at the recent hearing put it, “The people of New York, especially vulnerable Medicaid patients, should not become unwitting subjects in this experiment, especially absent their informed consent.” Amen.

Ambush in Angleton

By RICHARD A. EPSTEIN
August 22, 2005

CHICAGO — The most memorable observation in Frederick Wiseman’s
film, “The Thin Blue Line,” runs like this: “It takes a good Texas
prosecutor to convict the guilty … and a great Texas prosecutor
to convict the innocent.” Today, this wry remark applies to
plaintiffs lawyers, now that Mark Lanier, down in Angleton, Texas,
has drawn blood from Merck for its former blockbuster drug, Vioxx.

Forget the jury’s whopping quarter-billion-dollar verdict in Ernst v. Merck, because it’s cut 90% by the caps that Texas law places on
punitive damages. Still, where do $25 million in actual damages come
from? Robert Ernst died in his sleep, without pain and without
medical bills. His lost income as a Wal-Mart employee was small. But
the $24 million price tag for anguish and loss of companionship to
his widow Carol is off the charts. And for what?

Not the death of her husband, whose arteries were 70% clogged and who died, so Dr. Maria Araneta’s death certificate states, of arrhythmia, or irregular heart beat. No mention of any heart attack. But in his
dramatic eleventh-hour maneuver, Mr. Lanier whisked Dr. Araneta back
from the Arabian peninsula to testify conveniently that she really
thought that an undetected blood clot had caused the death, but had
been dislodged in the last-ditch efforts at resuscitation.

Pretend that this new account is true, and it still doesn’t show that Vioxx caused the blood clot. Long before Vioxx, people died of heart
failure from all sorts of causes, including physical exertion and
dehydration. That second causal link to Vioxx was not made even if
the first one to a blood clot is generously presumed. Carol Ernst’s
lawsuit should be DOA right here, but a clever set of jury
instructions allowed the jury to say that Vioxx may have been a
contributory cause of death.

By what odds? Merck’s clinical trials showed an elevated risk of
heart attacks but only in persons that took Vioxx in heavy doses for
intestinal polyps for 18 months or more. Ernst took Vioxx only for
eight months. In post-trial interviews, the jury members revealed
their anger that the company didn’t show “respect” for its customers
by telling the truth about Vioxx’s risks. And they clearly were moved by Mr. Lanier’s expert bashing of Merck’s medical employee, Dr. Nancy Santanello, who struggled to explain how Merck tried to show the efficacy of the drug in response to criticisms of it.

All this goes to show that physicians under the gun make lousy
witnesses, which we already knew. To understand the Angleton verdict, one would think that Vioxx were the moral equivalent of mustard gas.
But in truth, we should be grateful to any firm that speeds its
product to market when its anticipated use promises many more
benefits than adverse side-effects. Merck should not apologize for
pushing hard to win quick market acceptance; before Vioxx was
withdrawn, countless people with chronic pain were able to get on
with their lives. Now these folks are left far worse off because of a double whammy: a Food and Drug Administration that yanks too many
drugs off the market because it has no idea how to evaluate risk, and individual jurors who think it is their solemn duty to “send a
message” to the drug companies on whose products we so desperately
depend.

So, in return, I would like to send my message to Mr. Lanier and
those indignant jurors. It’s not from an irate tort professor, but
from a scared citizen who is steamed that those “good people” have
imperiled his own health and that of his family and friends. None of
you have ever done a single blessed thing to help relieve anybody’s
pain and suffering. Just do the math to grasp the harm that you’ve done.

Right now there are over 4,000 law suits against Merck for Vioxx. If
each clocks in at $25 million, then your verdict is that the social
harm from Vioxx exceeds $100 billion, before thousands more join in
the treasure hunt. Pfizer’s Celebrex and Bextra could easily be next. Understand that no future drug will be free of adverse side effects,
nor reach market, without the tough calls that Merck had to make with Vioxx. Your implicit verdict is to shut down the entire quest for new medical therapies. Your verdict says you think that the American
public is really better off with just hot-water bottles and leftover
aspirin tablets.

Ah, you will say, but we’re only after Vioxx, and not those good
drugs. Sorry, the investment community won’t take you at your word.
It realizes that any new drug which treats common chronic conditions
can generate the same ruinous financial losses as Vioxx, because the
flimsy evidence on causation and malice you cobbled together in the
Ernst case can be ginned up in any other. Clever lawyers like Mr.
Lanier will be able to ambush enough large corporations in small,
dusty towns where they will stand the same chance of survival that
Custer had at Little Big Horn. Investors can multiply: They won’t bet hundreds of millions of dollars in new therapies on the off-chance of being proved wrong. They know they’ll go broke if they win 90% of the time.

Your appalling carnage cries out for prompt action. Much as I
disapprove of how the FDA does business, we must enact this hard-
edged no-nonsense legal rule: no drug that makes it through the FDA
gauntlet can be attacked for bad warnings or deficient design. In
plain English, Mr. Lanier, you’re out of court before you make your
opening statement. You’ve already proved beyond a reasonable doubt
that the fancy diagrams that university economists use to explain why the negligence system maximizes social welfare is an academic
delusion that clever lawyers use to prop up a broken tort system.

So where does that leave Merck? Perhaps in Chapter 11, where this
madness may be brought to a halt.

Mr. Epstein, the James Parker Hall Distinguished Service Professor of Law at the University of Chicago and the Peter and Kirsten Bedford
Senior Fellow at the Hoover Institution, has consulted extensively
for the pharmaceutical industry. His book on the industry will be
published next year by Yale University Press.

There is not a short supply of politicians who think they know better than the FDA when it comes to protecting the public health. The most recent is California Attorney General Bill Lockyer. Mr. Lockyer feels that the FDA’s warning about tuna and mercury isn’t strident enough (even though the tuna industry went ballistic when they were issued) — and he wants to take the matter into his own hands. He wants to require signs on store shelves or labels on tuna cans in California warning of the dangers of mercury. I guess he was not aware that labels on food are, by dint of the federal Nutrition Labeling and Education Act, under the suzerainty of the FDA. Fortunately the FDA was more than happy to remind him. In a recent letter, FDA Commissioner Crawford helpfully reminds Mr. Lockyer that, “California should not interfere with FDA’s carefully considered approach of advising consumers of both the benefits and possible risks of eating seafood.” Sometimes the same lesson has to be learned more than once. In 2004, when the state tried to add warnings onto nicotine patches, the California Supreme Court ruled that FDA-approved warning labels for the products precluded the state from requiring additional warnings. It’s sad that, in Prop 65 World, products like nicotine patches that help you quit smoking, and tuna that provides valuable health benefits — even to pregnant women — require more warnings but not more educational promotion — particularly from the Bully Pulpit of elected office. Plato’s “Allegory of the Cave” puts forth the proposition that the unenlightened cannot tell the difference between shadow reflections and reality. In California, the “Allegory of the Tuna” teaches us that only politicians can see the truth — and science be damned.

Here’s what Senator Charles Grassley had to say in wake of yesterday’s Vioxx verdict, “The Food and Drug Administration was also negligent in the Vioxx case … Those running the nation’s public safety agency repeatedly dismissed the concerns of their own scientists and seemed to do everything possible to keep the public in the dark about emerging problems with Vioxx.” Not only is this untrue and unfair to the 10,000 FDA career employees who work tirelessly on behalf of the public health, it is also a very clear sign that the Senator from Blameland is more interested in chest-thumping than helping to advance the public health. Chalk up another one for “Body Slam Chuck,” the King of Destructive Criticism. And talk about bellying up to the tort bar! I wonder how much more money the Senator will get from the trial lawyer lizards as a reward for such vituperative rants?

A rant appeared on Dr. John Grohol’s World of Psychology blog assailing GlaxoSmithKline for targeting a direct-to-consumer education campaign at, well, the consumer. The author is peeved not only because GlaxoSmithKline and other drug companies actually make a profit, but that they are advertising their products by repackaging already available information. He argues instead that drug companies should spend shareholder dollars promoting free online depression information or, better yet, send people directly to psychologistsâ offices without mention of any drug. (This is particularly rich since the host site, which repackages and serves as a portal to already available information, prominently pushes a book by Grohol on which he is presumably earning a profit.)

It might never occur to the author that the advertising from a drug company is actually the impetus that pushes a person suffering from depression into a doctor’s office. After all, GlaxoSmithKline and all other drug companies are powerless to 1) force anyone to purchase company products or 2) even sell products directly to consumers. Drug companies must rely on the professional opinion of doctors who may or may not prescribe the company’s product that provided the push to get the patient to seek professional help.

If one thinks that depression is an under-treated condition that has negative consequences for individuals, rants such as this are irrational. Perhaps the author might want to spend some quality time on a couch.

I hope this verdict will not chill the nascent movement towards more open and transparent sharing of information between the pharmaceutical industry, FDA, physicians, and patients. Now is not the time to let lawyers rule.

Nope, not a typo. Fee Speech. Like in speech you get paid for. Specifically the kind of speech doctors use when they get paid to talk with the investment community. Some (now including the venerable NY Times) believe that doctors participating in clinical trials shouldn’t talk to investors for fear that they will share confidential information. Should clinical investigators share confidential information — most certainly not — but that’s a lot different than saying they shouldn’t be allowed to speak with Wall Street types. It’s a slippery slope, friends. First ne parlez pas avec investors and then, who else? How about reporters? How about patients? How about each other? Are we really willing to say adieu to the free exchange of (appropriate) scientific information? It’s odd to me (but, alas, not surprising) that the same people who want full disclosure of clinical trial data want to muzzle trial clinicians. This isn’t to say that loose lips shouldn’t be slapped shut, they should —but the way to deal with blabbermouth docs is to aggressively put an end to such behavior through legal and professional remedies, not by selectively applying the First Amendment.

The Los Angeles Times uncovered a price-gouging scam on our nation’s pharmaceutical consumers. Americans, eager to acquire price controlled brand-name drugs from Canada, have been filling there generic prescriptions up North as well. They’ve been overpaying by as much as 78 percent compared to what they could have purchased at the corner drugstore, according to a study by the Fraser Institute, on which the story relies. Canada’s complicated price control system, which also controls competition and provides an effective floor as well as a ceiling for prices, makes generic drugs a bad deal in Canada. The Fraser Institute study pegs the cost difference at 78 percent for the 100 most popular generic drugs. It has long been known among serious researchers, as opposed to bus hopping activists and politicians, that it’s unclear if the basket of drugs Americans actually purchase, due to an abundance of generics, costs more or less in the United States than it would in Canada.
One thing is clear: It’s the fierce competition of free market in the United States that produces both the innovation necessary for the cutting-edge drugs that Canada’s government price controls and the low, low prices for generic drugs that have lost patent protection.

Let me be blunt: The current political assault on direct-to-consumer advertising of pharmaceuticals is absurd, in that the essential “insight” underpinning such criticism is the preposterous premise that patients can be made better off by withholding information from them. But that eternal truth has not prevented those convinced that ordinary people are morons from arguing that the recent Vioxx fiasco (the public discussion, not the drug itself) would have been tempered had advertising not misled people into “overuse” of the drug. Oh, please. Consider an adverse drug effect that shows up in, say, three people in 100,000. In a clinical trial of 20,000 patients, it easily might not show up at all; that is the basic nature of the inference (“type 1/type 2” error tradeoff) problem afflicting all statistical analyses. Is it due to “negligence” that unknown problems might emerge in the general population of consumers? Or is it more fundamentally the result of the harsh reality that clinical trials are not free, and that larger ones would engender even greater costs, and thus fewer medicines and more human suffering over the long term? Only within the Beltway and among the plaintiffs’ bar is “a” the correct answer. And probably also in California.

There is a ballot initiative to be decided by the voters of California this fall — Proposition 79 — that would attempt and fail to deliver steep pharmaceutical price discounts to over half of the state population, even as it would enrich the lawyers. Call it the “Fewer Medicines and More Lawsuits” initiative. It would attempt to force those discounts for the middle class by excluding from the MediCal (California Medicaid) formulary drugs from producers refusing to accept the California price controls imposed by the bureaucrats and politicians. So much for the actual health interests of the poor and near-poor. In any event, the federal government (the Centers for Medicare and Medicaid Services) will not allow benefits for the poor to be mortgaged in favor of attempts by the political class to subsidize the middle class. That is what actually happened (or failed to happen) in Maine. What will emerge is an avalanche of lawsuits, because the initiative allows any citizen (that is, any lawyer) to sue on grounds of “profiteering” whenever a prescription is filled at an “unconscionable” price or at a price yielding a profit “unjust” or “unreasonable.” By the way, none of those terms is defined, and, no, the attorney needs no actual client. And the “antidiscrimination” provisions would force the price controls onto the entire market, and other states would find themselves unable to resist the pressures to impose a similar program, lest consumers in other states pay less. Presto! The long run collapse of the pharmaceutical sector would be upon us. Such are the wages of left-wing compassion.

This just in from the London Daily Telegraph, “Illegal sales of counterfeit medicines are booming, fuelled by a combination of the arrival of lifestyle drugs for ‘embarrassing’ conditions such as impotence, hair loss and obesity and their easy marketing on the internet, Britain’s drugs watchdog said yesterday.” Is this the first step towards blaming pharmaceutical companies for the frightening increase in global ethical drug counterfeiting? I’m sure there are some who will make that argument (hello Marcia!), but that’s not going to help address the problem. It’s like the old story about the police asking famous bank robber Willy Sutton why he robbed banks. His reply, “Because that’s where the money is.” The solution to drug counterfeiting isn’t fewer medicines, it’s increased vigilance. But, somehow I feel there are will be others who are ready and willing to blame pharmaceutical firms. How about this for a solution, no new drugs.

FDA Commissioner Lester Crawford has just announced that he and other members of senior agency management will travel to Miami, Boston, and Phoenix to hold open public meetings, according to the Wall Street Journal, “on any area the agency regulates, which includes drugs, medical devices, dietary supplements and most food products.” Well, that should certainly make for an interesting trip. Hopefully Les and crew will hear from some real people and not just politicians, “advocates,” and other sundry usual suspects. If you’d like to get on the agenda, visit http://www.grad.usda.gov/vision.

When Pfizer Vice Chairman Karen Katen appeared alongside Billy Tauzin at PhRMA’s recent announcement of the trade organizations DTC “Guiding Principles,” there was a lot of doubt as to whether her comments were anything more than supportive rhetoric. Well, today Pfizer proved they are willing, ready and able to really make a difference to DTC advertising and, more importantly, to truly advancing the public health.

At present risk information in DTC ads is neither designed nor delivered to be user-friendly. At present it is designed to be “in compliance” — and to truly advance the public health these things cannot be mutually exclusive. One of the things that Pfizer announced today is that they will undertake research (with input from the FDA and third parties) to help improve risk communication in DTC TV advertising, and will adjust risk communications accordingly. And, as far as the so-called “brief summary” is concerned, Pfizer has submitted to the FDA for review a new consumer-friendly and consumer-tested print brief summary. I hope they share their concepts more broadly, because if it works, there are broader public health communications lessons to be learned. And it’s about time because, as folks within FDA are fond of saying, the current brief summary is like the Holy Roman Empire. It is neither brief nor a summary. And it most certainly is not a useful public health tool. If Pfizer can help change this, more power to them — and to all of us.

And when it comes to disease awareness, the world’s biggest pharmaceutical company is stepping up to the plate and putting their money where their mouth is. In 2006, Pfizer will invest on par with what it spends on a branded advertising to create more disease awareness with advertisements that do not mention a product; address crucial public health issues such as health literacy, compliance and improving the patient/physician relationship through additional non-product advertising; and continue a dedicated advertising campaign to promote their “Pfizer Helpful Answers” program that helps people who need help affording the medications they need.

These announcements are more than programs inoculating Pfizer against the anti-DTC desperados. It’s about saving lives and saving our health care system big bucks. Improving disease awareness, treating people appropriately and promoting compliance with medical treatments helps eliminate the costs associated with under-diagnosis, under-treatment and untreated conditions, which often lead to more surgeries and expensive hospital care. Understandable and accessible information, in the form of direct-to-consumer advertising (disease awareness as well as branded messages) also helps with other costly factors, such as low health literacy (which costs our health care system approximately $58 billion annually) and noncompliance (estimated at more than $100 billion a year in increased emergency room visits, hospital and nursing home admissions, and lost productivity).

Kudos Karen.

The debate over FDA’s new Drug Watch plan is a bellweather for how the FDA views both the pharmaceutical companies it regulates and the public it must keep informed. PhRMA’s position is that “Plans by U.S. regulators to release preliminary information about potential drug side effects could lead to unnecessary confusion and irrational fears about medicines.” And, according to Reuters, “PhRMA also voiced concern that the FDA may not provide companies with adequate notice of new information for the Web site or a chance for input.” These are all rational concerns. Where’s Aristotle when you need him? Where is the moderation? Does the public deserve to know about potential risks earlier? Of course. But what does that mean? It should not mean scaring people with the results of early, often ambiguous studies. Unfortunately, the media and some politicians jump on these FDA postings to bash drugs that are, overwhelmingly, safe. Precipitous postings only magnify the media’s thirst for “the next Vioxx,” and magnify the unintended consequences of non-compliance. And unintended consequences are not in the best interest of the public health. But this does not mean that swifter release of appropriate science isn’t a crucial goal. It most certainly is and on this both sides agree. The proper answer, the “how to,” is somewhere in the middle — but seeking that out through dialogue and debate is exceedingly hard in today’s highly-charged political environment. It’s time for politics to take a back seat to science and the public health. It’s time to abandon the Precautionary Principle for the Aristotelean Mean.

Remember when Wrong-Way Rod Blagojevich said he was going to buy flu vaccine from non-FDA approved sources? Well, now it seems that he doesn’t want to pay for the roughly 700,000 doses because of a provision that allows termination for “unforeseeable circumstances beyond its reasonable control, including governmental regulation.” Last time I looked, the FDA told the Governor NOT to buy the vaccine in the first place BECAUSE IT WAS ILLEGAL.

But that’s never stopped Wrong-Way Rod before. Somehow I don’t think the “savings” earned from his embarrassing drug importation schemes are going to cover the cost of this latest fiasco.

Well, at least the White Sox are winning.

A welcome breath of sanity from from the leader of the Utah State Senate …

Preferred drug lists come with problems

Last week, the Utah Legislature’s Executive Appropriations Committee
declined to institute a Preferred Drug List policy that would require
Medicaid recipients to use drugs on a discount list or go through a prior authorization process. A few reporters and editors were quick to broadcast their assumption that this decision was driven by political contributions. That assumption is wrong. In 2001, the state of Maine implemented a PDL policy — one of the first in the nation. Six months ago, it issued a report which scrutinized Maine’s system and found what it characterized as “disturbing trends.” According to the report Emergency room visits have increased; Hospital admissions and patient referrals to specialists have increased;Many patients experience a worsening of their medical conditions as they jump through the hoops to get medications not on the PDL; Many patients are forced to go to the doctor multiple times to get the right medicine; Medical staff time and attention is diverted from patient care to handle “voluminous paperwork” and increased calls from patients; Doctors are cutting off or limiting the number of Medicaid patients they accept due to the increased administrative burden; and Quality of care has decreased and patients have suffered painful consequences. They reported, “while (a PDL) is an important cost containment tool, aspects of its implementation have adverse consequences directly affecting the health care of thousands.” Other PDL states are also experiencing serious problems. I found these concerns to be compelling. As a taxpayer and legislator, I would like nothing more than to save money in our Medicaid program. The bottom line for me, however, is that I am unwilling to conduct medical experiments on our most vulnerable residents. Some have asked why we don’t just approve a limited program to see how it would work. The answer is simple. We imagine that we might well save a significant amount of money in the short term, as have Maine and the other PDL states. Short-term savings, however, are only part of the equation. Let’s look at the dynamics that would be set in motion. A limited program is
likely to generate quick positive numbers while the long term impact and human cost would remain unquantifiable for several years.
Stories of frustration and tragedy would have a difficult time competing with clear financial data that would build political momentum in favor of PDLs, to the injury of a population that is already striving to overcome immense challenges. In other words, this train has no brakes. I do not want it to start rolling down the mountain when we know there are people on the tracks below.
Maine is currently investigating the administrative problems caused by its PDL program. At some point in the future, Maine plans to try to quantify the human damage caused by the program to determine if the money it saved was worth the cost. At this point, I am unwilling to plunge Utah into a similar experiment.Perhaps we can revisit the issue when the bugs are worked out of the PDL system. Seven legislators on Utah’s Executive Appropriations Committee voted for a
Utah PDL; nine voted against it. Each was lobbied fiercely from all sides of the issue. Each has their own reasons for the judgment call they had to make. They are all good legislators. They did their job.
You will find your representatives to be far more informed, far more
sincere, and more compassionate than the two-dimensional caricatures
portrayed by recent media accounts.

John L. Valentine is president of the Utah State Senate.

The one thing I got out of Gardiner Harris’ story in Saturday’s NY Times is that the current drug label isn’t a terrific public health tool. Just like its crainial cousin, the “brief summary,” it’s written more for liability protection than for physician/patient utility. And that’s a shame — especially now that the FDA is adding so many more warnings to already crowded spaces. While approprite language is crucial to responsible use, more and more black boxes won’t make the label any more used today than it was before the Grassley Inquisition. In fact, it might even lead to a hideous unintended consequence of “label fatigue,” where a black box is no longer viewed as an extraordinary thing. What a shame to cry wolf and only end up with Sid Wolfe.

Today’s words of wisdom from Nobel Prize-winning drug researcher and United States Senator Charles Grassley, “The F.D.A. should not be slowing things down or speeding them up depending on how the wind blows.” That certainly carries a lot of weight from a man who wears a weathervane on top if his head and, during Commissioner Crawford’s confirmation vote, needed to be reminded that the FDA doesn’t have the authority to mandate label changes. The answer, my friend, is not bloviating in the wind. Rather than commenting on the prevailing winds (which certainly seems a classic case of projection) perhaps Mr. Grassley should work to increase the FDA’s budget.

I’m sorry, did somebody say that counterfeit drugs are a “red herring” of the global pharmaceutical industry? The only comment I can make is, WHO’s on first.

LONDON - Worldwide, the WHO believes counterfeits make up between 5 and 8 percent of the $550 billion of medicines sold each year. But WHO spokeswoman Daniela Bagozzi said this was based on incomplete information and the actual amount could be higher.

“It represents a huge number of people who are suffering and in some case dying,” she said. “A lot of deaths could be avoided if the drugs being taken were not substandard counterfeits.”

Here’s a thoughtful article from a doctor who’s having a hard time “donating” staff time to helping patients navigate the often difficult paperwork problems of patient assistance programs. He’s trying to do the right thing. How can we help? URL for this article:
http://online.wsj.com/article/0,,SB112292676704701785,00.html