Medical Progress Today
  Volume 1, Number 17
  November 12, 2004


In the Spotlight

Mr. President, stay the course.
Robert Goldberg, Ph.D., 11-12-04

Mr. President, America has a drug problem and you're going to have to spend some of that political capital you earned this November to fix it if you want to get to work on some of the other important goals you have set for this country.

I am not talking about drug addiction. I am talking about the fact that over the past several years, and particularly during the last election cycle, the national discourse over prescription drugs has become so shorn of facts and reason that only your leadership can ensure that America remains the world's leader in developing better medicines for treating disease.

Continue reading . . .

Featured News:
Generic Maker Pulls HIV Drugs From WHO Use
Wall Street Journal, 10-4-04
Featured Commentary:
Commentary: Was Withdrawing Vioxx the 'Right Thing to Do'?
Holman W. Jenkins Jr., Wall Street Journal, 11-10-04
Featured Research:
A Critique of the Public Citizen and TB Alliance Reports
Tufts Center for the Study of Drug Development, 11-1-04

News

Keeping us alive is good business: PERSONALISED MEDICINE: Targeting small groups who will benefit most from a drug can be more profitable than first thought
Financial Times, 11-10-04

Personalized medicine - driven by the new science of pharmacogenomics - is the future of the pharmaceutical industry. By targeting the genetic basis of disease, companies that produce targeted drugs like Gleevec or Tarceva can provide higher treatment response in screened patient groups than traditional drugs. As many other commentaries have pointed out, targeted therapies will also help to insulate companies from the kinds of adverse effects (and liability exposure) that occur when drugs are used in very large, unscreened populations.

Take Genentech’s cancer drug Herceptin, which targets the HER/neu protein present in some breast cancers. To see if a patient can benefit from the drug, “physicians perform a genetic analysis of the disease before recommending it, because it has been shown to work well only in patients with a specific profile.” If the patient’s disease has the right protein, they get Herceptin - which also has fewer side effects than traditional chemotherapies.

Are targeted therapies good for a company’s bottom line? So far, the answer is yes. Herceptin “has become a best-seller, generating $450 million last year.” Analysts note that Herceptin, Gleevec and other targeted drugs are extremely effective in screened patients, “and the market will support a higher price for life-saving treatments.” Last, but not least, pharmacogenomics should help to lessen the time and cost involved in drug development, since targeted drugs can be tested in very select patient groups and should show definitive results relatively quickly. The real question is whether or not industry and the FDA can adapt quickly enough to the reality that there is no such thing as a generic disease that is the same in all patients.

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Diet Drug Helps Patients Maintain Lower Weight: Sanofi Pill, Which Blocks 'Munchie' Receptor, Shows Other Health Benefits, Too
Wall Street Journal, 11-10-04

Don't throw away your sneakers yet (or ever, really), but an experimental weight loss drug has shown early evidence that it can not only help patients lose weight, but it may help also them keep the weight off, control "bad" cholesterol, and moderate blood sugar levels. Since both cholesterol and blood sugar are significant risk factors for heart disease and diabetes - which are epidemic in the American population - the drug could turn out to be an enormous boon for patients and physicians. Patients in the latest clinical study of the drug lost an average of 17 pounds the first year of treatment, and "maintained their weight for an additional year."

Researchers say that "the drug blocks receptors in what is called the endocannabinoid system in the brain", "which also reside in fat cells and in nerves in the stomach, [and] play a critical role in regulating appetite." The drug, from Sanofi-Aventis, will be up for FDA drug approval by late 2005 or early 2006.

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Generic Maker Pulls HIV Drugs From WHO Use
Wall Street Journal, 10-4-04

The Bush administration has expressed concerns that generic combination AIDS drugs produced for use in poor nations have not proven their bioequivalence to patented drugs - at least not to the satisfaction of U.S. regulators - and until those concerns are met, the government’s $15 billion AIDS initiative would only purchase FDA approved drugs. This position has only met with scorn and derision from international AIDS activists, who accuse the U.S. of being a shill for the pharmaceutical industry.

However, recent events have vindicated the U.S. position. In August, the World Health Organization, which maintains a list of drugs recommended to treat AIDS, delisted 5 medicines from generic Indian manufacturers - two from Cipla and three from Ranbaxy - after finding discrepancies “between lab data examined during the inspections and lab data that the companies had previously submitted to the WHO to prove equivalency.”

Now the other shoe has dropped and Ranbaxy has withdrawn “all of its generic HIV treatments” from the WHO list, “saying that it can’t be sure the drugs are exact replicas of patented treatments they seek to copy.” The drugs haven’t been pulled off the market - and may still turn out to be safe and effective. But that’s not the point. The entire purpose of regulatory agencies is to ensure the safety and effectiveness of all medicines, no less for generics than for patented drugs. To waive these requirements for generic AIDS drug manufacturers risks substandard medications reaching patients in desperate need of real help. Unfortunately, this issue seems to have been forgotten in favor of a harangue against intellectual property rights. Perhaps now real attention will be paid to the issue.

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Merck Faces U.S. Criminal Probe Over Vioxx Drug
Wall Street Journal, 11-9-04

There are two words that describe the rise and fall of Vioxx: moral hazard. For instance, Vioxx was an expensive drug in a crowded field of prescription pain relievers, including many cheap generic ones. This has earned the company no small amount of criticism. However, Merck is just playing the game according to rules others have written. Physicians and consumer groups have worked hard to tie the hands of insurers and HMOs when it comes to reimbursement - meaning that insurers don't bother much trying to push back against consumers or physician preferences. Physicians, for all of their carping about Vioxx, didn't pay for it, and were only to happy to write a prescription for it if someone asked - even after suspicions were raised about its heart attack risk.

Merck ran a great advertising campaign, it's true, but no one ever runs out and buys an SUV because of a great commercial - because they wind up paying the bill. It might be a different story if an insurer had to write a check every time a consumer opted for the Hummer instead of the Volkswagen beetle.

Vioxx would've been a great drug for a select group of patients, at high risk for gastrointestinal problems, or who couldn't tolerate other NSAIDS. But Merck - and patients, and doctors - all saw a big green light the end of the reimbursement tunnel and they all happily drove through it.

Third party insurance for routine health care creates an enormous moral hazard for all of the players in the health care sector. As Milton Friedman once pointed out, no one uses insurance to buy groceries or mow the lawn, but we do use health insurance to pay for Vioxx when aspirin or ibuprofen might do as well.

The tort lawyers and industry critics, will, of course, write a different story. They will talk about Merck's greed, FDA incompetence, and innocent consumers taken in by seductive advertising. Still, the real culprit driving this particular problem is that Americans have come to treat all health care expenses - major, minor and everything in between - as a Right that someone else has to pay for.

If the rise and fall of Vioxx should teach us anything it should be that the jokes on us - and we're all paying for it.

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New Vision-Loss Drugs Offer Hope
Wall Street Journal, 11-9-04

Macular degeneration is the leading cause of blindness among American elderly and could reach epidemic proportions as baby boomers age. For instance, "by 2025, more than 11 million Americans will suffer from the condition." Although there is currently only one drug approved to treat macular degeneration (Visudyne), several other drugs are on the way. One drug, Lucentis, from Genentech, has shown an ability in early clinical trials to reverse eye damage. Another new drug, Macugen, shows promise as well. "In a trial of over 1,100 patients, those who didn't receive the drug lost twice as much vision as those who got Macugen." As more treatments become available, scientists think that "the brightest hope for macular degeneration treatment may be drug combinations similar to the cocktails that fight cancer and HIV."

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Medicare faces cost crisis; Multitrillion-dollar deficits loom over federal programs
The San Francisco Chronicle, 11-7-04

Compared the unfunded liabilities of the federal government’s Medicare and Medicaid programs, the Social Security deficit pales in comparison. “Looking more than 75 years into the future [one economist] estimates that the nation faces a $62 trillion unfunded liability for Medicare - versus a $12 trillion gap for Social Security.” The choices appear stark and there are no shortage of doomsayers amongst policymakers and pundits.

Still, angst on this issue is generated by many in an attempt to engineer yet more government intervention in health care markets. There is, however, ample reason to reject the notion that the sky will inevitably fall - in 20 years, let alone 75.

The most significant reason for optimism is technology itself. Anyone who thinks they can tell you what health care costs will be like 75 years from now is kidding themselves. No one in the 1970s could predict the enormous productivity gains from the personal computer in the 1990s, and no one now can predict health care advances in the next 10, 15, or 20 years, when new sciences like genomics will really begin to blossom.

Rather than hamstring tomorrow’s health care markets today, we should focus on building more patient control and responsibility into the system, and let industry do what it does best: develop new technologies. A system with the right incentives, including consumer control and high quality information about providers and treatments, will help us solve the insolvable.

Pessimism in measured doses is an important impetus for policy reform; too much pessimism is a recipe for blind panic.

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F.D.A.'s Drug Safety System Will Get Outside Review
The New York Times, 11-6-04

In response to the firestorm raging over Vioxx, the FDA has asked the Institute of Medicine, one of "the government's top scientific review" institutions, to examine the FDA's drug safety system to determine if it is adequate or in need of revision. The FDA has also begun setting up an internal appeals process for regulators within the agency who "feel that superiors have made a mistake by approving a drug or, after approval, refusing to order its recall." In the event of a serious disagreement, "that person will be able to make a case before a committee of experts, from inside and outside the agency, who were not involved in the decision."

This may be all to the good, but it seems to perpetuate an either/or mentality at the agency. The reality is that even drugs like Vioxx, which are safe for the vast majority of users, can be left on market provided doctors have the ability to screen out patients at high risk for adverse events. The crux of a radically new system of patient safety would rely on pharmacogenomics studies and better statistical modeling before and after a drug was approved for marketing to monitor how the drug is metabolized by different groups of patients. Right now, we are a far cry from that goal and won't get any closer to it if the FDA's response is to circle the wagons and become even more risk averse than it already is.

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Vulnerable System -- Behind Flu-Vaccine Shortage: Struggle to Police Drugs Globally -- Chiron Case Shows Failure Of Agencies to Swap Data; A Bad News Wake-Up Call -- Rising Overseas Duty for FDA
Wall Street Journal, 11-5-04

Lurking behind the partisan sniping over the flu vaccine shortage is a troubling issue that has widespread implications for other pharmaceutical issues, from bioterrorism to drug importation.

With the globalization of the pharmaceutical industry, and ongoing consolidation of companies, the FDA is increasingly burdened by the need to inspect manufacturing plants in far-flung corners of the world that supply medicines for the American market. To date, the agency is proving less than equal to the enormity of the challenge. In short, there is no international regulatory system for pharmaceuticals, and the FDA lacks the human resources to inspect foreign plants on a regular, thorough basis. “In 2000, the FDA said in separate reports that it was falling ‘considerably short’ on biennial inspections outside the vaccine area and that the ‘globalization of the pharmaceutical industry is outpacing our resources to inspect pharmaceutical plants world-wide.” This is a huge gap in FDA oversight, and a troubling footnote to the rush to legalize drug importation from countries well-beyond the familiar Canadian market.

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Lawyers Organizing for Mass Suits Over Vioxx
The New York Times, 11-5-04

Lawyers are gathering in this week in Pasadena, California to decide how they will carve up their Christmas turkey - sorry, the Vioxx litigation against Merck, one of the world's largest pharmaceutical companies. The California conference will be open to defense lawyers; an additional conference will be held on November 11 in Las Vegas only for members of the plaintiffs' bar.

Even before Merck withdrew Vioxx from the market, hundreds of cases alleging harm from the drug had been filed against the manufacturer - now, with the stakes increased exponentially, the number of cases is sure to explode. "The plaintiffs' lawyers plan to compare notes next week on the types of clients who may make the strongest cases, with a premium on people who were in demonstrably good health before taking Vioxx. The group also intends to discuss ways to cooperate in gathering evidence and expert testimony, and in devising tactics to influence where the bulk of the cases may end up, as state and federal judges consolidate them. . . . Many lawyers will also be jockeying for roles that will maximize their influence, and ultimately their reimbursement, as the litigation unfolds."

Perhaps, when everything is said and done, the lawyers will all be happy. If they are, however, it is very likely that there will be no more Merck - hardly a good outcome for industry, patients, or global health.

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$18B tab possible in recall of Vioxx: Study says Merck could face more than 50,000 lawsuits
NJ.com, 11-4-04

One FDA researcher estimates that, out of the approximately 20 million people who took Vioxx at one time or another, about 27,000 patients may have suffered serious or fatal cardiovascular events as a result of their exposure to the drug. One investment analyst predicted that "given the large number of Vioxx users, the publicity surrounding the recall, the types of litigation such attention typically generates, and Merck's 'deep pockets', we believe the number of claims filed that do not involve serious cardiovascular events could [be surprising]." Translation: plaintiff's lawyers are likely to file large class action suits with thousands of members, some of them with dubious or nonexistent injuries related to Vioxx. That will increase their leverage in court, although it may also hurt the chances of individuals with serious injuries from receiving the compensation they deserve.

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Flu Vaccine Goes Further With a Shallower Shot: Technique Could Improve Protection, Stretch Supply; Further Testing Is Needed
Wall Street Journal, 11-4-04

Two new studies published in the New England Journal of Medicine suggest that small doses of flu vaccine injected into the skin of “healthy young and middle-aged adults offered similar protection to a full dose injected into muscle, the traditional way of administering vaccines.” The dilution of the vaccine is made possible because there are immune cells in the skin layers that are “poised” to fight off invading infections, rather than in the muscle tissue, where the vaccine must travel to lymph nodes before eliciting an immune response.

Although these findings won’t be validated in time to affect the current flu vaccine shortage, larger clinical trials testing the method could help it to become the standard procedure for delivering vaccines.

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Medicare Tweaks Preventive Plans
Wall Street Journal, 11-4-04

In the U.S., about 80 percent of all health care dollars are spent on 20 percent of the patients. Thus for that small part of the population - suffering from chronic diseases like heart disease, asthma, diabetes, or cancer - advances in the treatment and prevention of those conditions could lead to significant savings in total health expenditures. With this goal in mind, the Centers for Medicare and Medicaid Services is increasing payments to physicians and hospitals by an average of about 4% next year to encourage the use of more preventative forms of health care. “Too many beneficiaries haven’t used services that make it possible to detect and treat illnesses before they lead to serious health problems and avoidable health care costs,” said CMS Administrator Mark B. McClellan. “Under the new law, we’ve modernized Medicare to include preventive benefits and appropriate payments for these services, and we intend to close the prevention gap for seniors.”

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Commentary

Commentary: Was Withdrawing Vioxx the 'Right Thing to Do'?
Holman W. Jenkins Jr., Wall Street Journal, 11-10-04

Mr. Jenkins thinks that the Vioxx withdrawal was a blunder. On balance, the market and physicians had been aware of risks with the drug since a large clinical trial in 2000 first hinted at the problem. Later, the Wall Street Journal ran “a front-page story on the heart risks of Vioxx and other so-called Cox-2 drugs on August 21, 2001.” And, to top it all off, trial lawyers were coordinating a national litigation effort “by early 2002.”

What changed this year? Good question. Jenkins concludes that “Merck is in hot water now not because Vioxx was excessively risky, but because the wrong people were taking it - a problem for which doctors and the insurance system are also to blame.” In fact, according to one researcher, “the biggest determinant of whether a patient takes a Cox-2 or a cheaper drug is whether an insurance company is paying.” Overall, Jenkins concludes - rightfully, we think - that “the Vioxx debacle is symptomatic of a system that shields consumers from price signals and sometimes actually discourages them from making the right health-care choices.”

Commentary: Shortages beyond flu shots
Jennifer Brower, Washington Times, 11-9-04

This op-ed, by a policy analyst at the RAND Corp., points out that the flu vaccine is far from the only problem plaguing the nation’s vaccine supply system. “In the past six years there have been U.S. shortages of more than half of the 12 recommended childhood vaccines, and there could be more.” Ms. Brower recommends quick action to remedy the problems, which she says involves “a combination of tax incentives, liability protection, purchasing guarantees, and patent protections to do much more to ensure the adequate supply of vaccines and protect Americans from one of the largest sources of preventable death.”

Editorial: Medicine Tests
Washington Post, 11-8-04

The Post offers praise for the Medicare Administration's willingness to pay for expensive new drugs and procedures provided that "patients who use them agree to participate in studies of effectiveness." Eventually, the Medicare administration will use the data gathered in such studies to decide which procedures should be eligible for reimbursement, and which should not. "Over time, such studies could begin to force American medical practice to become more evidence-based and less subject to the expensive whims of fashion. If pricey new procedures don't show greater success than older, less costly ones, Medicare should refuse to pay for them."

The Post goes on to wonder if Medicare officials will be able to ward off the lobbyists from companies who champion pricey but ineffective treatments. That, we would argue, is not really the problem. As long as medical care is driven through third-party insurers, perverse incentives will drive spending priorities. Instead, the government should enlist the aid of the only group with real power over spending: consumers. Properly equipped with financial leverage, consumers will demand cost-effective treatments and providers - with, of course, help from the government in assembling information about quality adjusted outcomes.

Remove unnecessary regulatory barriers on development of nutritionally enhanced food staples, Says Campaign for Fighting Diseases
Campaign for Fighting Diseases, 11-4-04

Biotechnology represents one of the most promising new technologies for eradicating hunger, eliminating diseases from nutrient deficiencies, and reducing the use of pesticides in the environment - that is, if regulators can bring themselves to evaluate these new tools honestly and fairly.

The Campaign for Fighting diseases “calls for the removal of unnecessary barriers on the development and use of biotechnology to improve the benefits of food staples in poor countries.” This would be a great gain for the developing world, but some Luddites in the environmental movement in Europe and America (where nutrient deficiencies are practically unheard of) are using the “precautionary principle” to keep poor nations environmentally pristine - while people are dying.

Question: Are these the same people who criticize the pharmaceutical companies for being cold-hearted?

What Federal Workers Are Doing Today that You Can't
Robert E. Moffit, Ph.D., Heritage Foundation, 11-8-04

If you want to see a prototype for consumer driven health care, there is one place that would probably be last on your list: the federal government.

However, the reality is that the Federal Employees Health Benefits Program allows millions of federal employees the power to choose their own insurance plans from a cornucopia of options. Federal employees in the FEHBP have options that few of their fellow citizens have: they can pick from a wide range of health plans (PPOs, HMOs, and Health Savings Accounts), a wide range of benefits packages, deductibles, coinsurance, etc.

Plus, during the open enrollment period (from November 8 through December 13, 2004) enrollees can do something very few Americans can do without quitting their jobs: they can fire their insurer and hire another.

Welcome to our discussion on medical malpractice
James R. Copland, PointofLaw.com, 11-10-04

Given the explosion of Vioxx litigation, and other pharmaceutical related liability issues (regarding vaccines, bioterrorism, etc.), we would like to introduce our readers to our sister website, “Point of Law” (pointoflaw.com), which focuses on reforms and debates related to America’s runaway tort litigation system. More information legal issues can be found at the Manhattan Institute’s Center for Legal Policy, at http://www.manhattan-institute.org/html/clp.htm.

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Research

A Critique of the Public Citizen and TB Alliance Reports
Tufts Center for the Study of Drug Development, 11-1-04

The Tufts Center for the Study of Drug Development has published a very well regarded estimate on the costs of drug development - published in a peer reviewed economics journal - from “invention to regulatory marketing approval”: approximately $800 million. Critics of the pharmaceutical industry, particularly the consumer advocate group Public Citizen, have published their own estimates, which are substantially lower than the Tufts figure. These estimates have been cited approvingly in several public critiques of industry, but according to Tufts “these reports have not undergone anonymous peer review, and have not been scrutinized fully for methodological flaws or the propriety of using results from them as comparators from our work.”

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Angiotensin-Converting Enzyme Inhibition for the Treatment of Hypertension: New Findings in Old Subjects
Medscape, 11-5-04

This study, based in Australia, followed cardiovascular outcomes in elderly patients suffering from hypertension who were randomized to receive either an angiotensin-converting enzyme inhibitor (ACE inhibitor) or a diuretic. After 4 years of treatment, similar blood pressure reductions were noted in both groups (-26/-12 mm Hg), but the ACE inhibitor achieved an “11% reduction in cardiovascular outcomes and death for subjects” relative to the diuretic group. “These findings suggesting that an [ACE inhibitor] are as effective in lowering blood pressure as diuretics in elderly hypertensives…and conferring an additional benefit beyond that from blood pressure reduction alone, are discussed in context of recent trials comparing newer vs. older antihypertensive drug treatments in elderly subjects.”

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Medical Progress Today is published by the Center for Medical Progress at the Manhattan Institute for Policy Research.

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HOME

SPOTLIGHT

Mr. President, stay the course.

NEWS

Keeping us alive is good business: PERSONALISED MEDICINE: Targeting small groups who will benefit most from a drug can be more profitable than first thought
Diet Drug Helps Patients Maintain Lower Weight: Sanofi Pill, Which Blocks 'Munchie' Receptor, Shows Other Health Benefits, Too
Generic Maker Pulls HIV Drugs From WHO Use
Merck Faces U.S. Criminal Probe Over Vioxx Drug
New Vision-Loss Drugs Offer Hope
Medicare faces cost crisis; Multitrillion-dollar deficits loom over federal programs
F.D.A.'s Drug Safety System Will Get Outside Review
Vulnerable System -- Behind Flu-Vaccine Shortage: Struggle to Police Drugs Globally -- Chiron Case Shows Failure Of Agencies to Swap Data; A Bad News Wake-Up Call -- Rising Overseas Duty for FDA
Lawyers Organizing for Mass Suits Over Vioxx
$18B tab possible in recall of Vioxx: Study says Merck could face more than 50,000 lawsuits
Flu Vaccine Goes Further With a Shallower Shot: Technique Could Improve Protection, Stretch Supply; Further Testing Is Needed
Medicare Tweaks Preventive Plans

COMMENTARY

Commentary: Was Withdrawing Vioxx the 'Right Thing to Do'?
Commentary: Shortages beyond flu shots
Editorial: Medicine Tests
Remove unnecessary regulatory barriers on development of nutritionally enhanced food staples, Says Campaign for Fighting Diseases
What Federal Workers Are Doing Today that You Can't
Welcome to our discussion on medical malpractice

RESEARCH

A Critique of the Public Citizen and TB Alliance Reports
Angiotensin-Converting Enzyme Inhibition for the Treatment of Hypertension: New Findings in Old Subjects
Center for Medical Progress 
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