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I noticed a recent letter to the editor of The Hill from Congressman Anne M. Northup, arguing that the importation of drugs subject to foreign price controls would be consistent with both safety and patent protection. (Yes, Ms. Northup is a woman; “Congressman” is a title and not a description.) She is incorrect in both dimensions because she ignores the implications of foreign price controls on pharmaceuticals. As it would be very difficult to monitor the shipments, reverse shipments, cross shipments, and other machinations to which the legalized importation of drugs would give rise, pharmaceuticals purportedly imported from, say, Germany, in fact would carry a real risk of actual production almost anywhere. North Korea and Pakistan come to mind. And there is no need to speculate about this: The recent discovery of thousands of doses of counterfeit Lipitor in the UK is only the latest example of the fake drugs about which we know. Moreover, the foreign price controls are forced upon the pharmaceutical firms by governments threatening to confiscate patents; it is Orwellian, to say the least, for Northup and others to argue that only “patent-protected” drugs would be imported.

Northup and others argue that the importation of pharmaceuticals subject to price controls would be a manifestation of “free trade.” Please. That is analogous to an argument that the purchase of stolen merchandise from the back of a truck is “free enterprise.” It is the effort of foreign governments to use price controls to obtain free rides on the research and development costs borne by U.S. consumers that is the real problem; the importation of foreign price controls will merely reduce future cures in favor of present wealth transfers. Sadly, Northup is concerned above all with present voters.

New segmentation schema for the food pyramid: Tall. Grande. Venti.

Just saw this news item —

Statin drug may save lives of heart attack patients, according to a study of more than 170,000 patients. A study published in the American Journal of Cardiology shows that taking statin such as Pfizer Inc.’s Lipitor, the world’s best-selling prescription drug, within 24 hours of admission for a heart attack can markedly reduce the risk of early complications and of dying in the hospital.

“This is the largest study to look at whether very early use of statin therapy after (a heart attack) can influence clinical outcomes,” Dr. Gregg C. Fonarow, from the University of California Los Angeles, was quoted as saying by Reuters Health. The results do, in fact, “suggest that statins offer additional protective effects early.” The research led by Fonarow involved comparing records of more than 170,000 patients in the National Registry of Myocardial Infarction. The registry, coordinated by Genentech Inc., has collected data on more than 2.3 million heart-attack patients since 1990.

That’s certainly good news, but here’s the question — would statins be approved today under the current political environment? Unfortunately, that’s a debatable question. It’s worthwhile to remember that “back in the day,” Bob Temple saw the value of statins when the category was new and the data was spare. Temple saw the wisdom and lives were (and are) saved. FDA serves us best when it strives to both protect and advance America’s health. Imagine health care today minus statins. Imagine the dollars spent on hospitalizations. Imagine the lives lost. The wisdom of Temple is wonderful, but the FDA as Temple of Wisdom is essential. And science and politics don’t mix.

Down the Hatch

  • 08.29.2005

Last we heard from Minnesota Attorney General (and presumptive Democrat gubernatorial candidate) Mike Hatch, he was thumping his chest while announcing the state’s intention to sue drug companies for their attempts to keep drugs earmarked for sales in Canada in Canada. It seems Mr. Hatch took exception to drug companies telling their Canadian distributors that if they sold drugs illegally to Americans their supply would be cut off. I know, it sounds strange — a state AG suing drug companies for trying to keep foreign pharmacies from purposely breaking US law. But this is, after all, Minnesota. In any event, Mr. Hatch’s announcement got a lot of news coverage and garnered him a prominent speaking engagement in front of the Families USA national conference in Washington, DC (after me and before Senator Ted Kennedy). That was over two years ago. The news on Friday that a Federal judge dismissed the case went almost unnoticed. But the ruling says it all — “Denied as Moot.” There is sanity in the world of pharmaceutical litigation after all.

Designer Drugs

  • 08.29.2005

Business Week offers an insightful cover story on the promise of and impediments to smart drugs — products that target narrower subsets of a population depending on individual genetics and the specifics of the condition. The stories are fascinating reads, containing material familiar to industry insiders and hangers on but news to the public.

Embedded in the tale is the central role of profit-seeking companies, such as Switzerland’s Roche. The company bet against the best advice of its own scientific advisors and laid down $300 million in 1991 on a poker hand that indirectly led to the development of AmpliChip, a device that promises to pinpoint which drugs will help specific individuals. The stifling role of regulation is indirectly covered through a feature on FDA Deputy Commissioner Janet Woodcock, who recognizes and is addressing legitimate industry fears about narrow markets and overbroad regulation. “It isn’t that there are some bad drugs and some good drugs,” says Woodcock, in a quote that could be entered by the defense in any number of Merck’s Vioxx trials. “It’s that some drugs run into bad problems with a small subset of people.”

And, of course, unnamed naysayers and professional worriers appear, fretting that any progress may lead to increased spending on health care and life insurance denials.

“Not only is the field still immature but it is also beset with concerns about public policy and privacy. Experts fear individuals may be denied life insurance, health insurance, or even a job if they’re known to harbor genes for a debilitating illness. Also, there is a debate about whether personalized medicine will reduce or increase health-care spending. Better diagnostics would let doctors intervene more quickly, avoiding some costly procedures. But hospitals may also order more and more tests indiscriminately to cover themselves against possible lawsuits for not detecting diseases before it’s too late. And those tests can be expensive: A test for abnormalities on the BRCA1/2 genes implicated in certain breast and ovarian cancers costs $3,000 a piece.”

The possible lawsuits ought to be addressed with medical malpractice reform, not a halting of progress. As for the $3,000 price tag, ask yourself if this is too much to pay if the person in question was your husband or wife, partner, child, mom, or yourself? I’d take two just for safety, as would many others. The larger issue has to do with price controls. Although unstated, every promised advance detailed in this feature would disappear tomorrow if drugs were subject to price controls. That’s the real risk.

BRAC FDA

  • 08.28.2005

BRAC FDA

Dan Troy is right. The more FDA’s critics attack the agency, the more conservative some of the career staff becomes. This is partially defensive (think “turtle retreating inside the shell”) — but it’s worse. It’s the FDA sliding down the slippery slope of the Precautionary Principle wherein safety, rather than being a relative concept, becomes finite. And that’s just not possible. Perfection is an ideal to strive for, not a reality to wait on. If the FDA’s professional staff chooses to wait for perfection then new drugs will simply not come to market and the implications of that are just too profound to ignore. It’s time for an FDA BRAC process to begin. It’s time that Bureaucrats Realize Actions Count.

It is time to supersize Bill Lockyer’s brain because the California AG just keeps making the same basic mistake. He doesn’t understand that the FDA has jurisdiction over food safety. His latest attempt at playing Elliott Spitzer Jr. is to demand warning labels on potato chips and French fries (which, by the way, he admits “sure taste good”). Bill, lockyer self in a room and read the Nutrition Labeling and Education Act.

And be particularly cautious about those beachballs — especially in California.

MICHAEL KINSLEY
Whose Vioxx is gored?
Michael Kinsley

August 28, 2005

Litigators are circling like alligators around the quivering drug company Merck. Estimates of what Merck ultimately may have to pay people who used its pain pill, Vioxx, rise every day: $50 billion is the highest bid so far. Last week, in the first case to come to trial, a Texas jury awarded Carol Ernst $253 million over the death of her husband. She may get a mere tenth of that. But there are nearly 5,000 Vioxx lawsuits. Just type “Vioxx” into your favorite Internet search engine to see why that number may rise to 20,000.

Merck has set aside $675 million just to cover its legal expenses. But the lawyers collect from both sides. If Carol Ernst gets $25 million, about $8 million of that â the traditional one-third â will go to her lawyer, Mark Lanier. Lanier says that after he pays off the law firm that turned the case over to him, plus other expenses, he’ll be “lucky to get 10%.” Shucks.

You may be under the impression that Merck did something terribly wrong in putting Vioxx on the market. But the Vioxx cases don’t generally claim that.

Instead, they are based on the last refuge of the tort lawyer: the “duty to warn.” Any product carries some risk. If you slice up a beach ball, saute it and eat it, the consequences could be dire. But even the world’s greatest lawyer would hesitate to argue that this is the fault of the beach ball manufacturer. That doesn’t mean the lawyer won’t take your case. He or she will take it and argue that the manufacturer should have warned purchasers that beach balls are not edible, cooked or raw.

The duty to warn is one of the law’s great celebrations of hindsight. When something actually has gone wrong, it is hard to argue (especially to a jury) that this development is too unlikely to worry about. And it is nearly impossible to argue that consumers shouldn’t be given information to decide for themselves.

Speaking for myself, I set aside one day a month exclusively for reading all the warning labels on products I have bought, such as beach balls. Then I assess whether the risk I am undertaking exceeds the benefit I hope to gain. But I wonder how many of my fellow citizens are so scrupulous.

I wonder, in particular, how likely it is that Carol Ernst’s husband would even have noticed such a warning on the side of the box or bottle or speed-mumbled during one of those eerily atmospheric TV commercials for prescription drugs.

Or, if he noticed it, would he have acted? It might have saved his life, but only in the way that deciding to take a later flight has saved your life when the earlier plane crashes. There is no actual connection. The studies Merck is accused of ignoring suggest a small increased risk of a heart attack among people using Vioxx for more than 18 months. Robert Ernst had used Vioxx for only eight months, and he didn’t die of a heart attack. He died of a different heart ailment known as arrhythmia. Lanier persuaded the jury that the arrhythmia could have been caused by an earlier heart attack that left no trace.

The absurdities pile on. Everyone but a few extreme libertarians can agree that the government has a legitimate role to play in protecting us from dangerous prescription drugs. Only the government can make rules that are uniform and consistent over time, so that investors in drug research can rely on them.

But in our current system, the government plays two conflicting roles. The FDA approves or disapproves a new pharmaceutical, weighing the trade-off between risk and benefit. And then the court system comes along and sees that trade-off differently. The fact that Vioxx was approved by the FDA carries little authority in Tort World, where thousands of juries in hundreds of courts of the 50 states will draw the line in other places.

Vioxx was a nearly unnecessary product. It came on the market in 1999 as an expensive alternative painkiller for people whose stomachs couldn’t handle cheap pills such as ibuprofen. Merck’s real offense was selling Vioxx to millions of people who didn’t need the stuff. It did so by abusing the power of advertising, the reality of insurance and our national penchant for shortcuts in the pursuit of happiness. But the entire pharmaceutical industry is guilty on those charges, which apply to safe drugs as well as dangerous ones.

Then there is justice. Foreigners look with amazement on a society that gives Carol Ernst $17 million or so in trade for her 59-year-old husband — more than he’s worth to anyone else and yet almost insultingly inadequate to her — and gives tens of millions to a few lawyers like Lanier, and is about to institute a transparently phony plan to provide prescription drugs that do work to people who need them, but with no money to pay for them.

From an interview with Janet Woodcock that will appear in the September 5 cover story of Business Week …

Q: What’s your vision of how drugs can be used in better, more targeted ways?

A: The overall vision is a medical vision: that we can get better outcomes for people and get a higher percentage of people who actually respond to any given treatment. Instead of your doctor telling you that 40% of the population responds to a drug, he can tell you that if you take this drug, you have a 90% chance of responding.

On the flip side, our vision is that there aren’t bad drugs or good drugs. Instead, some drugs run into bad problems with a small subset of people. Instead of taking all those drugs off the market or putting warnings all over them, we need to make sure that people who are at high risk for a side effect don’t get the drug in the first place.

The vision is that this will actually decrease the cost of health care. We know there is a tremendous burden from adverse events of drugs, and everyone agrees we can do a much better job.

Thanks Janet. Hopefully words presage deeds.

Smart Shopping

  • 08.26.2005

When asked how consumers can save money on their prescriptions (other than caveat emptor importation), I always point out that comparison-shopping between pharmacies can have a huge impact. So kudos to Cigna for their new web site that shows drug prices for 52,000 pharmacies nationwide (both brick-and-mortar and Internet). This site allows Cigna customers to compare the costs of both brand name and generics. (The prices vary based on the kind of insurance held.) The web site will also alert patients when drugs they are shopping for may interact with other medications they’re taking — not only saving out-of-pocket costs, but potential costly hospitalizations and other complications.

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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