Latest Drugwonks' Blog
In the movie “Marathon Man,” Lawrence Olivier’s Mengele-inspired dentist threateningly asks, “Is it safe?” That same question, under post-Vioxx fear, apprehension and recriminations, has the real threat of crippling open and honest scientific exchange at some high profile FDA advisory committees in September. Worse is the possibility that today’s bilious environment will keep new treatments from waiting patients. Worse still is the risk that such a Precautionary Principle-driven climate will drive the pharmaceutical industry away from important new therapies towards only the safest, least innovative R&D projects. These are frightening thoughts — and attention must be paid lest we find ourselves, micron-by-micron, abdicating the hope of 21st century medicine to politically expedient measures that serve only to further the political aspirations of sound-bite hungry politicians and the voracious appetites of trial lawyers.
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.
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.
