Latest Drugwonks' Blog

Caution needed in helping the FDA
By Boston Herald editorial staff
Sunday, June 25, 2006

The top Republican and Democratic members of the Senate committee dealing with health, Sens. Michael Enzi of Wyoming and our own Ted Kennedy, have begun preparing a bill that would give the Food and Drug Administration new powers over drug safety.

Some new powers are needed, but we fear Congress may go too far.

Senators are reacting to the withdrawal of Vioxx and similar drugs after the discovery that these stomach-friendly painkillers increased the risk of heart attack when taken for 18 months.

The FDA would get the ability to order changes in a drug label after it goes on sale and the power to force manufacturers to live up to any promises to conduct post-approval safety studies. Experience shows these are needed improvements.

But the bill reportedly (a text is not yet available) sets up dispute resolution procedures and requires the FDA to publish formal plans for evaluating and mitigating risks of every new drug, complete with schedules and timetables. All this would just augment the agency’s “avoid mistakes” culture. Its bureaucrats know they will be pilloried for approving a drug that later reveals problems, but will be left alone if overcaution delays the sale of something useful.

Caution has costs. Approval of Erbitux, a new treatment for colon cancer, was withheld in 2001 because not all the study patients had failed conventional therapy. The drug was approved 27 months later. Colon cancer strikes about 8,700 people every month; Erbitux (used with another drug) halts tumor growth for 4.1 months. The delay thus cost about 80,000 person-years of tumor arrest.

The FDA has improved its once-draggy performance. Average time to approval of new drugs fell from 22 months to 14 from 1993 to 2003; time to approval for promising drugs in fast-track review fell from 13 months to six. Congress should do nothing to slow it down.

Frank Lichtenberg of the Columbia Business School has estimated that on the average each new drug approved in 1970-1991 saved 11,200 person-years of life in 1991 alone, and presumably each year thereafter. New drugs yielded a return to society of 40 percent per year on the cost of development, he calculated.

All drugs have side effects. The senators would do well to encourage the taking of worthwhile risks, perhaps by mandating the use of sound cost-benefit analysis in surveillance of drug safety.

Great piece today in the NY Post by Dr. Marc Siegel about how the fearmongering by the media and certain members of Congress is driving his patients away from taking medicines that can keep them alive. Marc has written well about how we should use science — not fear — to guide policy and medical decisions.

Here’s the entire article:


June 23, 2006 — MEDICINES are too often portrayed as either life savers or killers - a polarization of our pills that serves neither science nor health care.

Thanks to two high-profile lawsuits, my patients are now asking me if Lipitor - the cholesterol-lowering drug - is still safe. With the suits claiming that Lipitor can cause brain and nerve damage, my old comeback - “I take the drug myself” - is no longer sufficient to calm fears. One patient tells me that I’m blindly ignoring the risks of serious side effects.

In fact, Lipitor, the country’s top-selling prescription drug, has been shown to prevent the progression of coronary plaques in patients with heart disease, and is likely to be as useful in patients who are at risk for heart attack and stroke from these same plaques.

The most potent drug in the class known as statins, Lipitor has been successfully administered to millions. In very rare cases, it can trigger a severe muscle breakdown known as rhabdomyalysis. It has never been proven to cause memory loss or nerve damage, and I and most other physicians believe it to be a safe and effective drug.

So why the worry? Part of the problem is the way the drug industry hypes its products, setting them up as some kind of panacea. But if it’s sold as a magic elixir, the discovery of any flaw rings alarm bells.

Not all drugs that are victims of the pendulum swing from panacea to panic are as famous or as successful as Lipitor. This month, an FDA safety panel also cancelled a study where 4,000 children were to receive the antibiotic Ketek, an effective treatment for bronchitis and sinus infections. Why stop the study? Ketek, a new drug, has been prescribed to over 5 million people over the past two years, but 12 have sustained liver failure (in four cases, fatally), while 23 others have suffered damaged livers.

Should Ketek be restricted, labeled with ominous warnings or taken off the market entirely? Not without much better evidence of danger. At a time when few new antibiotics are being developed, drug-resistant bacteria continue to emerge, drugs like Ketek are important tools.

Unfortunately, when the media and the lawyers target a drug, they overlook the fact that the side effects are rare, and/or alternative treatments more problematic. Sober statistics-based analysis gets tossed aside. The drug-maker’s stock price and the number of prescriptions written plummet.

Decisions on drug safety should be based on real facts - a weighing of the real risks and benefits. Hysteria doesn’t belong in the drug-safety equation.

Dr. Marc K. Siegel is an internist at NYU Medical Center and associate professor at the NYU School of Medicine.

Owing to genuine concerns about pedigree and counterfeiting (courtesy of the FDA’s aggressive use of the Bully Pulpit), together with the successful rollout of the Part D drug benefit, the issue of foreign drug “re-importation” has lost much of its political allure and momentum. Most of the elected officials calling for the “legalization” of foreign drugs have since abandoned their incautious and dotty schemes. Aeternum vale!

But political bloviation abhors a vacuum. Taking the place of drugs are too expensive is the new clarion call of drugs are not safe. A sure-fire political winner. After all, who could be against “safety?” Safe = Good. Unsafe = Bad, right? Well, not exactly. As Dr. Mark Goldberger, director of FDA’s office of antimicrobial products commented, “It’s more complex than it seems at first glance.”

Safety has been hijacked. Safety is the new Re-Importation. But it’s the same old story.

And it sure plays in Peoria or, perhaps more appropriately, in Des Moines. Not surprisingly, the media loves it because; although the pressure point is different the “victim” (the patient) and “the villain” (the pharmaceutical industry) are the same. And, as everyone knows, it’s more than okay to kick the stuffing out of Big Pharma (or, if you prefer, “Big Pinata”). It’s a free hit. Sanctimonious quotes and macho strutting results in terrific headlines for the folks back home.

A little harmless politicking? Hardly. Just ask the people who no longer have access to the medicines they need (like Vioxx), or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result is a dearth of new medicines in the pipeline.

Is it safe? Ask the FDA. Is it politically safe? Ask a Senator. Is it remunerative? Ask an attorney.

What does “safe” mean, anyway? 100% safe? Certainly not. All drugs have risks as well as benefits. And more often than not the more serious the disease the more serious the risks associated with the treatment. Consider advanced non-small cell lung cancer. Then consider Iressa. Are such medicines risky? Indeed they are. Are the diseases they treat serious enough for patients to accept such risks? Decidedly. Consider Multiple Sclerosis. Then consider Tysabri.

But most importantly, consider the Precautionary Principle, the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines. Fatal like in death.

Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.

I should also add that the VA doesn’t pay pharmacy costs. And that’s anywhere between 20%-40% of the purchase price. One more time folks — a half truth is a whole lie.

Here’s an email I received from a producer at ABC about the Families USA “study.” The fact that it gets plastered and picked up as the default position that has to be defended against should tell you all you have to know about coverage bias…but read the entire email and get a load of the stacked questions I am supposed to answer. The full article about FUSA was attached to the email.

” Pasted below is Families USA News release on the cost of drugs under the Medicare prescription drug plan. World News Tonight Weekend is interested in a possible story looking at the issue of whether prescription are in fact now costing LESS for MORE seniors. Below are some questions. We will forward your responses to the ABC News correspondent and producer working on this story.

-What are your views on whether most seniors are or are not saving money on prescription drugs?If they are saving, could they be saving more? And if so, why not?

-Are prices of many of the most popular drugs going up? And if so, why?

-And what is the longterm impact on the plan of those rising prices?

-Are seniors who are saving on some drugs, just losing those savings to other now more expensive ones?

-And are the drug companies making even more money now because of this plan? “

Oy gevalt!

The battle continues apace. Please have a look at this new op-ed (penned by myself and Dr. Bob) that appears in today’s edition of The Washington Times.

And please pass it along.

Here’s the link:

I am being cautioned not to regard the two page summary upon which most of the news accounts of the Enzi-Kennedy bill are based as definitive or the final version. Indeed, the two page summary ignores the creation of an agency that would support the creation of tools that would accelerate drug development and promote targeted medicines. The agency would use public and private partnerships such as the Critical Path Institute to fufill the mission and objectives of the Critical Path initiative. This is an imaginative and thoughtful effort to modernize the FDA through scientific collaboration.

In context then, the onerous risk management proposals set forth in the two page summary seem to be totally inconsistent with the effort to improve drug safety post market by increasing the pre-marker ability of the FDA and companies to identify and select populations that would respond significantly to medicines and provide biomarker based screens to reduce the rare liver and heart problems associated with drugs.

Instead, the risk management program is mainly busy work and studies of the sort that will never identify rare events with the certainty hope for by proponents. In particular the risk management effort post market makes the nightmare Scott Gottlieb fears — of physicians too worry of prosecution or lawsuits or too busy to comply with yet another mound of risk management paperwork, tests, followups — controlling clinical decisionmaking of doctors. It is also an example of the agency — not the doctor or patient — deciding what is best for them.

How shameless can a politician be…Chuck Schumer attacking Merck for lowering it’s Zocor prices in response to impeding generic competition..Interestingly, when he introduced changes to the law promoting generic drugs he lauded his proposals as “all about promoting competition in the drug industry…” Except when it comes to creating competition for generic drug firms? Since when did they become a protected class and since when did protecting them become more important than consumers. Since about 15 percent of consumers stick with a generic after a switch, a Zocor price slash will save them money, Schumer rather than later.

June 20, 2006, 2:03PM
Senator Raps Drug Giant Over Zocor Price

By DEVLIN BARRETT Associated Press Writer
© 2006 The Associated Press

WASHINGTON â A New York senator accused the drug giant Merck & Co. on Tuesday of conspiring to undercut a cheaper generic alternative to its cholesterol-lowering drug Zocor just days before it becomes available to patients.

Sen. Charles Schumer, a Democrat, charged that Merck is quietly collaborating with health insurance companies to create lower copays for customers buying Zocor than for those buying the generic equivalent.

Zocor generated $4.4 billion in sales last year, and generic alternatives will be available for the first time on Friday. A company executive scoffed at Schumer’s allegations.

“It appears that Senator Schumer is criticizing us because he says that our prices are too low. That’s a new one,” said Ian Spatz, Merck’s vice president for public policy.

“The truth is that we support generic competition and the generic competition for Zocor is good for patients. It’s good for people who have to pay for medicine, which include health plans. We’re going to continue to price it competitively,” he said.

Both Peter and I were concerned about Gardiner Harris’ article in the NYT which depicted the Enzi-Kennedy FDA bill as a throwback to go slow paper gathering approaches to drug safety without regard to 21st century science orproposals to accelerate a response to the more expensive and prevalent ‘side effects’ of having a disease like Alzheimer’s without effective treatments.

As the Yiddish proverb goes: “A half truth is a whole lie.” The bill does encourage risk management activities and trial disclosures. But Senator Enzi and Kennedy have spent a whole lot of time on Critical Path issues and discussing the science behind it, how to fund it, etc. There is a considerable amount of attention and language devoted to accelerating drug development and using biomarkers and other methods to encourage targeted — and safer — medicines.

Why did Gardiner leave this out? Were his sources selective or was he?

One possible clue: Here’s a guy who has a problem differentiating between suicide and suicidal ideation, ignoring research that demonstrates that suicide has gone down with use of SSRIs and the role that genetic mutations play in causing adverse reactions to SSRIs and other antidepressants one of which is suicidal thinking (which is NOT suicide).

But, to be fair, he is not alone in this, so we’ll give Gardiner the benefit of the doubt.

The take away from all this: those opposed to the Critical Path and faster cures will use the MSM to shape public perception. The reality is more robust and hopeful. And as Anna Mathews mentions in the last line of her story in today’s Wall Street Journal, the bill “would authorize some resources for an FDA effort to spearhead research on drug evaluation.”

Can you say penny-wise and pound foolish? This from Health IT News.. The GOP stalls a bill to encourage the diffusion of health IT because it might — I repeat might — drive up health care spending in the short term as people invest in new hardware and systems to achieve interoperability and patient-centered. Would these Republicans have stalled investment in the highway system or the transcontinental railroad because it drove up costs in the short term?

House Republicans stall healthcare IT bill
Healthcare IT News
By Bernie Monegain, Managing Editor 06/20/06

WASHINGTON â A healthcare IT bill the U.S. House of Representives was expected to vote on this week is expected be put on hold.

Congress Daily reports the move to hold off on the bill came after the Congressional Budget Office forecast the legislation would increase spending and reduce revenue.

The bill bill promotes the adoption of healthcare information technology and calls for national standards for implementing electronic health records.


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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