Medical Progress Today
  Volume 2, Number 11
  March 17, 2005


In the Spotlight

The Cost of Germs

Betsy McCaughey, New York Sun, 3-17-05

Too often, patients are contracting deadly infections in hospitals. The humanitarian reasons to correct this problem are obvious. But there is also a compelling economic case, and now is the time to make it, as the Medicaid budget is being discussed.

Continue reading . . .


Featured News:
Drugmakers likely to lob softer pitches Consumer ads come under scrutiny
USA Today, 3-16-05
Featured Commentary:
Life is Too Short Here to Worry About HIV
Roger Bate, Tech Central Station, 3-11-05
Featured Research:
Bevacizumab Combined With Chemotherapy Prolongs Survival for Some Patients with Advanced Lung Cancer
National Cancer Institute, 3-14-05

News

Drugmakers likely to lob softer pitches Consumer ads come under scrutiny
USA Today, 3-16-05

Direct-to-consumer advertising by pharmaceutical companies is coming under increasing public scrutiny and criticism.

“Not only has the Food and Drug Administration promised to step up policing of consumer drug ads that make unrealistic claims, but legislators in four states also have recently introduced bills that would ban or curb consumer drug ads in their states.”

However, the backlash against pharmaceutical advertising threatens to throw out the baby with the bathwater. Advertising for medicines increases public awareness of new treatments for illness and even improves how doctors treat diseases like depression, which is still, by most accounts, undertreated.

Drug companies have powerful incentives to advertise, since drugs are very expensive to create, and companies often reach market with similar products nearly simultaneously - meaning that they compete for market share and profits with the same groups of patients.

Competition in the marketplace leads companies to sponsor head to head studies (on drugs like statins, or medical devices like drug eluding stents), educates physicians on which treatments are best for which patients, and even produces valuable new scientific knowledge.

Advertising also has bottom line benefits for patient health. Deaths from heart disease in the U.S. have plummeted in recent years, mostly due to lifestyle changes (less smoking), and better surgical procedures (angioplasty, heart bypass) but also thanks to the proliferation of statins - safe, relatively cheap drugs that keep heart disease in check. If companies couldn’t maximize their revenues through advertising, they would have less of an incentive to ensure that Americans at risk of heart disease receive appropriate treatment.

Still, the poster child for successful pharmaceutical advertising is depression. The treatment of depression became much more common over the past decade in large measure as a result of advertising for a new class of drugs (SSRIs) and one drug in particular, Prozac.

David Cutler, an economics professor at Harvard University, writes in his book Your Money or Your Life, that “Prozac clearly revolutionized the treatment of depression in medicine…[and] highlights the power of financial incentives in medicine. Prescription medications cost an enormous amount to develop…But after the drugs have been developed, producing additional pills is very cheap. Pharmaceutical companies charge a lot for a pill to recoup their initial research and development and to earn profits….Responding to this incentive, Eli Lilly (Prozac), Pfizer (Zoloft), SmithKline Beecham (Paxil), and the rest of the pharmaceutical industry spent billions of dollars getting people to see their doctors for depression and getting doctors to diagnose and treat disease.” [Ed: emphasis added.]

Cutler admits that there some forms of advertising may step over the line, and that some drugs may be over prescribed as a result. However, he also disagrees with the idea that government should prohibit advertising. “We need to remember the good side of this behavior - pharmaceutical company outreach gets depressed people into the doctor’s offices and on medication. Under diagnosis and under treatment were major problems with the old system. Pleading with doctors and government advisories never solved these problems. Advertising and detailing are somewhat noxious, but they work.”

Vioxx has taught the industry something about the perils of advertising blockbuster drugs to mass numbers of consumers. The pharmaceutical industry already seems to be shifting from advertising specific medicines directly to consumers to more of a disease education approach. However, heavy handed regulation - or even worse, an outright ban on drug advertising - would do more harm than good.

When it comes to educating the public and treating diseases that affect large population groups quickly and effectively (for heart disease, depression, and similar diseases), advertising is and will remain a valuable tool for improving public health.

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Doctors seek cure to rash of anti-drug advertising: US medics are worried about 'alarmist' warnings spread by lawyers searching for new clients
Financial Times, 3-16-05

To continue our discussion of direct-to-consumer advertising, consider the issue of someone with high blood pressure or severe depression, who seeks treatment from a doctor because they saw a drug ad or heard about a new treatment. Whether or not you like pharmaceutical companies or drug advertising, it is at least arguable that those ads have tangible health benefits because they encourage people to seek help from a professional.

Now, imagine you are person with one of these disorders who is under a doctor’s care. One day, while riding on a subway, you see an advertisement describing how the medicine your doctor prescribed for you has horrible side-effects. Terrified, you stop taking your medicine without even consulting your doctor (who, if you listen to the plaintiff’s attorneys, is really just an unwitting dupe of the drug companies).

This is exactly what is happening in New York, where doctors are concerned that advertising by plaintiff’s lawyers exaggerates the risks of commonly used medicines and is leading patients to discontinue valuable treatments.

“One advertisement on the New York subway can be enough to undo years of careful treatment of mentally ill patients in the care of [Dr.] Ralph Aquilla. Usually, about 400 people walk in every day for medical treatment and job training at Fountain House, where Dr. Aquilla works in Manhattan’s Hell’s Kitchen district. But some patients suddenly stop coming to see him – even after months of regular contact, he says - in response to warning that their medication, known as atypical antipsychotics, can be harmful for schizophrenics. The adverts are an example of what doctors, companies, and independent experts say is a rapidly growing national problem of alarmist and misleading claims by lawyers seeking new clients. Attorneys use the ads to claim that [these drugs used to treat mental illness] can cause diabetes and even complications that lead to comas or death.”

Says Dr. Aquilla: “It’s a pretty tough kind of thing for people who don’t necessarily have the (mental) resources to weight what’s going on. The repercussions can be truly, truly, tremendous.”

Advertising by pharmaceutical companies is carefully monitored by the FDA. Advertising by attorneys is much more loosely regulated by the Federal Trade Commission, which “pays little attention [to the ads] because the messages are either protected by a constitutional right to free speech or are the responsibility of state authorities because they are broadcast only locally.”

In other words, attorneys have a financial incentive to “scare up” new business by exaggerating the real - but very rare - side effects of medicines that treat severe mental illnesses. Drug companies are under stringent FDA regulations to prove that the benefits of their medicines outweigh their risks, and that their advertising is truthful and accurate. Unfortunately, personal injury attorneys don’t have to meet the same test.

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Genentech Drug Shows Effect on a 2nd Cancer
The New York Times, 3-15-05

A new clinical trial sponsored by the National Cancer Institute has shown that Genentech’s cancer drug, Avastin, increased survival in patients with advanced lung cancer.

Avastin is a drug in a new class of cancer therapies that inhibits the growth of blood vessels in tumors (antiangiogenesis) effectively starving them of the nutrients they need to grow.

“In the trial…patients who received Avastin along with standard chemotherapy drugs had a median survival of 12.5 months, compared with 10.2 months for those receiving only the chemotherapy.”

The lead investigator in the trial, said that “it was the first big trial he was aware of in which survival for patients in the advanced stage of nonsmall lung cancer - the most common type – exceeded one year.”

One noted side-effect of the treatment, bleeding from the lungs, is a very serious and even potentially fatal side-effect. Genentech and the researchers will present their full findings in May at the yearly meeting of the American Society of Clinical Oncology.

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Aspirin Sensitivity Found in More Than One Quarter of Cardiac Patients on Aspirin Therapy
Medscape, 3-14-05

Americans take millions of aspirin every day in the hopes that this commonly used drug will help reduce the risk of a heart attack or stroke from coronary artery disease. Aspirin is cheap, relatively safe, and proven effective.

That is, for people who aren’t “aspirin resistant.”

“Chinese investigators report finding a high prevalence of aspirin resistance in patients with cardiovascular disease on aspirin therapy. Aspirin resistance has been linked to an increased risk of adverse cardiac events…Overall, 27% had aspirin resistance, they found. Those most likely to have resistance are those most at risk of mortality from their disease.”

Chinese researchers found that aspirin resistance varied by population group and co-morbidity: “women (46.1%), smokers (11.5%), diabetics (39.1%), those with hypertension (72.7%), hyperlipidemia (68.8%), renal insufficiency (18.8%), and low-dose aspirin (90.6%) had the highest incidence of resistance….The highest incidence of aspirin resistance occurred in those taking 100 mg daily or less, while no resistance was found in those taking more than 300 mg daily.”

Identifying patients with aspirin resistance is critical so that doctors can adjust dosage or use other therapies. However, currently, there is no test that is “ready for prime time."

Aspirin resistance is another example of the growing need for personalized medicine - tools that can help doctors create individual treatment regimens for patients that take into account the enormous variability of the human population.

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New Therapy Shows Promise In Heart Attacks --- Addition of Blood Thinner Is The First Big Improvement In Drug Treatment in a Decade
Wall Street Journal, 3-10-05

Researchers conducting two studies have found that giving a blood thinner (called Plavix) to heart attack patients as part of “the usual emergency drug regimen can help save lives and prevent second heart attacks.”

“In the bigger of the two studies, there were 7% fewer deaths in patients given Plavix. The other, smaller trial showed 20% fewer serious heart ‘events’ after 30 days, including death and a second heart attack. The combined treatment can also significantly improve chances that the affected artery will remain open after treatment…a result associated in other studies with improved long term recovery and survival from a heart attack.”

The development of new drug therapies is critical because although the “the optimal treatment for a major heart attack” is balloon angioplasty, “only about 20% of hospitals -- mostly major medical centers -- have the technology to perform them. In most communities, patients usually can't be transported from other facilities in time for effective care.” As a result, most hospitals treat heart attack patients with drugs alone.

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Commentary

A Troubling Drug Combination
The New York Times, 3-15-05

The New York Times says that “Pfizer’s plan to market a promising new cholesterol drug only in combination with one of its existing products may well make sense as a business decision. But it will limit the flexibility of doctors to prescribe the best mix of medicines and is a disservice to patients who might fare better taking the new drug alone or in combination with drugs that Pfizer doesn’t make. It’s also a terrible precedent for the pharmaceutical industry.”

Pfizer may tie its new drug, torcetrapib, with its established statin drug Lipitor, which goes off-patent in 2010, ensuring the combination of drugs will reap continued sales and profit from Lipitor after its goes off-patent.

While the Times considers this a cause for concern, we would add an important caveat. Torcetrapib will probably turn out to be just the first drug in this new class of medicines - cholesteryl ester transfer protein (CETP) inhibitors - and not the last. Just as there are 6 different statin drugs competing for market share, CETP inhibitors will, if successful, turn out to be an equally crowded class of drugs.

Is it “bad” for Pfizer to tie its statin with this new drug? That is far from clear right now. It may actually, in the long run, hurt Pfizer’s sales of the drug if a competitor comes out with a stand-alone CETP inhibitor that allows doctors to prescribe it with any statin. Or, on the other hand, combination statin drugs may become popular because of their convenience and efficacy.

In the meantime, there is no reason to worry. Companies should remain free to maximize their profits and respond flexibly to a highly competitive market environment. Ultimately, boosting profits now means more research and more medicines in the future.

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Rules Are Killing Good Science
Henry Miller, M.S., M.D., Los Angeles Times, 3-14-05

Miller addresses an issue we have written on quite a bit recently, the backlash against new conflict of interest rules at the National Institutes of Health by NIH employees.

“The National Institutes of Health has used a bazooka to kill a mosquito. And now the NIH is facing a revolt from its scientists, who are suffering collateral damage.”

Miller believes that “requiring that federal employees disclose outside consulting arrangements is entirely appropriate, and an NIH scientist should not hold significant equity in or be an officer of a company that wants to sell something to his agency, or whose product he is testing in a clinical trial.; nor should he receive cash awards from institutions whose grants he can influence.”

However, as long as scientists competently discharge their duties and disclose “extramural activities”, they should “enjoy significant latitude to become involved in outside part-time employment or volunteer work, as is largely the case in academia.”

Miller believes that the new rules are draconian and punitive, and that “America will pay the price if the nation’s preeminent research institution is jeopardized, and its accomplishments diminished.”

In short, “Heaven protect us from the good intentions of bureaucrats.”

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The Quality Cure?
The New York Times, 3-13-05

The subject of this extended article and interview is David Cutler, renowned Harvard economist and health care guru. Cutler is a smart and articulate advocate for shifting our national debate on health care from costs to quality, and encourages policymakers to begin “paying for [health care] performance.”

“[Cutler] says that most health-care spending is actually good. Spending has been rising, he says, because it delivers positive, and measurable economic value, and because it can do more things that Americans want. Therefore…we should focus on improving the quality of care rather than on reducing our consumption of it.”

Cutler thinks we can accomplish this transformation through a twofold approach: “First, he proposes a variant of the voucher system. let the government finance people’s – everyone’s – health care, with tax credits to be spent on private providers or insurers. But vouchers would only broaden the system, not improve it. To accomplish the latter, Cutler wants insurers, both public and private, to redesign the way doctors and hospitals are compensated, to give them an incentive to compete on quality.”

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Life is Too Short Here to Worry About HIV
Roger Bate, Tech Central Station, 3-11-05

Discussion of the AIDS crisis in Africa hinges mostly on funding and foreign aid, particularly for antiretroviral drugs. Unfortunately, less discussion is devoted to how we should address the political and economic roadblocks that hinder treatment and magnify the diseases’ terrible toll.

For instance under Robert Mugabe’s dictatorship, “Zimbabwe's rapidly escalating humanitarian disaster, which has manifested itself in chronic shortages of food, medicine, fuel, electricity and hard cash, has driven over three million Zimbabweans into South Africa, Botswana and other neighboring states. Prior to the crisis, Zimbabwe's population estimate was 12 million, which means that over 25 percent of the population is now living elsewhere. The diaspora of Zimbabweans into neighboring countries either to escape political victimization by President Mugabe's regime or to find work is substantially worsening the AIDS problem in southern Africa. Many refugees report being assaulted or raped on arrival and destitute young women frequently end up as prostitutes.”

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RX FOR MEDICARE
Lois Quam, The Boston Globe, 3-11-05

Another way to implement the “quality cure” mentioned by Cutler is for health care providers to improve how they treat and manage patients with chronic diseases like diabetes and heart disease, which are very expensive conditions that make up a disproportionately large share of private and public health care expenditures.

Quam believes that the survival of both the Mediciad and Medicare programs may depend on transitioning these enormous federal programs to a payment model that rewards health care providers for treating chronic diseases more effectively.

“Chronically ill patients with five or more medical conditions made up only 20 percent of all Medicare beneficiaries in 2004 but accounted for more than two-thirds of the program’s $302 billion in costs…Too often these patients must make sense of an array of confusing, even conflicting information. This fragmentation of care can lead to poor health outcomes that are unnecessarily costly and draining for patients and physicians alike. We can reduce this burden by organizing our resources more efficiently and effectively. The traditional Medicare and Medicaid fee-for-service systems are structured primarily to provide acute care, not to meet the needs of the chronically ill. These latter patients require comprehensive management of their health, emphasizing coordination of multiple treatments, health maintenance, and prevention of disease.”

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Research

Bevacizumab Combined With Chemotherapy Prolongs Survival for Some Patients with Advanced Lung Cancer
National Cancer Institute, 3-14-05

Researchers at the National Cancer Institute have released the “preliminary results from a large, randomized clinical trial for patients with previously untreated advanced non-squamous, non-small cell lung cancer [showing] that those patients who received bevacizumab (Avastin™) in combination with standard chemotherapy lived longer than patients who received the same chemotherapy without bevacizumab.”

Patients who received standard chemotherapy in combination with Avastin “had a median overall survival of 12.5 months compared to patients treated with the standard chemotherapy alone, who had a median survival of 10.2 months…Detailed results from this trial will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO) to be held in Orlando, Fla., on May 13-17, 2005.”

Designer or “targeted” cancer treatments like Avastin work by "targeting molecular pathways critical to the growth and survival of cancer cells” and represent some of the most promising new treatments for cancer.

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

For more information about Medical Progress Today, please contact the managing editor, Paul Howard, at phoward@manhattan-institute.org, or via telephone at 212.599.7000.

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SPOTLIGHT

The Cost of Germs

NEWS

Drugmakers likely to lob softer pitches Consumer ads come under scrutiny
Doctors seek cure to rash of anti-drug advertising: US medics are worried about 'alarmist' warnings spread by lawyers searching for new clients
Genentech Drug Shows Effect on a 2nd Cancer
Aspirin Sensitivity Found in More Than One Quarter of Cardiac Patients on Aspirin Therapy
New Therapy Shows Promise In Heart Attacks --- Addition of Blood Thinner Is The First Big Improvement In Drug Treatment in a Decade

COMMENTARY

A Troubling Drug Combination
Rules Are Killing Good Science
The Quality Cure?
Life is Too Short Here to Worry About HIV
RX FOR MEDICARE

RESEARCH

Bevacizumab Combined With Chemotherapy Prolongs Survival for Some Patients with Advanced Lung Cancer
Center for Medical Progress 
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