Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 03-08-2005

With Risks of Painkillers Unclear, A Long-Term Study Is Proposed
Wall Street Journal, 3-8-05

The problem with focusing on the risks of new drugs is that we often have poor information about the risks of the older drugs they are designed to replace. The poster child for this problem is the recent discovery of cardiovascular risk in a very small percentage of patients taking Cox-2 inhibitors.

Is this risk unique to Cox-2 drugs? Or is there a similar risk with all non-aspirin NSAIDs? We know that NSAIDS have a high risk of gastrointestinal injury, but do they have a cardiovascular risk associated with them because they also inhibit Cox-2 enzymes to some degree?

Older NSAIDs like naproxen or ibuprofen were approved under less stringent FDA rules than new Cox-2 drugs, and haven’t been studied for long term safety in the patient groups most likely to be taking them - seniors who are more vulnerable to heart attack and stroke.

As a result, “Robert Temple, director of medical policy for the FDA's Center for Drug Evaluation and Research, has proposed a long-term study that would pit a half-dozen drugs, including Celebrex, ibuprofen and naproxen, against one another. The test would look for cardiovascular and gastrointestinal risks in patients who need medicine to manage arthritis pain. ‘I find the totality of the evidence sort of difficult to comprehend,’ says Dr. Temple, referring to studies to date. ‘There's just lots of data that doesn't line up very well."

The idea of holding a “mega-trial” that would pit a number of pain medicines (old and new) head to head is an intriguing idea, but it raises a number of questions that would have to be considered before hand.

For instance, is a large clinical trial the best way of understanding how individual patients react to specific drug treatment regimens? While we might find out some very interesting things about population-wide side effects and efficacy profiles, that information might not turn out not to be very helpful for individual doctors and patients.

After all, if I’m a patient with crippling arthritis, I don’t need to know what drug is safe and effective on average, I need to know what drug is safe and effective for me.

Not every drug works equally well or is equally hazardous for every patient. As one arthritis specialist noted, we need more “studies that would help predict which patients would respond to particular drugs” because doctors simply keep prescribing different medicines until they find one that works. Currently, trial and error prescribing is the best we have, and no mega-study will change that.

Large trials might reassure some safety experts or statisticians, but not many patients or their doctors.

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Quit smoking with a pill? Researchers say new drugs show promise
Associated Press Newswires, 3-8-05

According to the American Cancer Society, 440,000 Americans die every year from some form of tobacco use, which is more than alcohol, car accidents, suicide, AIDS, homicide, and illegal drugs combined. At least 30% of all cancer mortalities (and nearly 90% of all lung cancer deaths) can be attributed to cigarette smoking alone.

However, physicians still lack many effective tools to help Americans quit smoking beyond moral suasion. Currently, many of the patches and pills used to treat nicotine addiction merely substitute one form of nicotine for another in the hope that smokers can eventually kick the habit.

However, “major pharmaceutical companies and small startups see the potential for billions of dollars in sales for a vaccine or a nicotine-free pill that could end addiction at the chemical level for America’s 50 million smokers.” Researchers are rushing to create drugs that can break the cycle of addiction by “[mimicking or blocking] nicotine’s chemical reactions with the body.” One drug, varenicline, currently in Phase III trials, was designed in the hopes that it would “attach to nicotine receptors in the brain, preventing overpowering cravings from setting in when someone stops smoking.”

Is there a magic pill on the horizon that will help smokers quit cold turkey? Probably not. But as companies bring new treatments to market the proliferation of options and technologies increases the likelihood that every smoker can chart their own individual course to better health.

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The Informed Patient: Doctors' Dilemma: How to Make Patients Stick to Their Regimens
Wall Street Journal, 3-9-05

A well publicized study from the Institute of Medicine has shown that tens of thousands of Americans die every year from preventable medical errors. Less well known is that patient compliance - following doctors’ orders and taking prescription drugs as recommended - is also a serious, indeed life threatening, problem.

“[F]or reasons ranging from forgetfulness to denial, roughly half [of patients] don’t follow doctors’ orders or take medicines as prescribed…According to the Merck Manual, the leading medical text, noncompliance leads to 23% of nursing-home admissions, 10% of hospital admissions, and countless extra doctors visits, tests, and procedures. Noncompliance among patients with cardiovascular disease alone causes 125,000 deaths annually.” [Ed.: emphasis added]

In other words, non-compliance mortalities are about three times larger than the number of people killed (40,000) in auto accidents on our nation’s highways.

Compliance isn’t just an issue of personal responsibility. Non-compliance - of patients with diabetes, heart disease, depression or other expensive chronic illnesses - drives up costs for public and private insurers and consumes scarce health care funding. How to improve compliance?

Put a price tag on it.

Some health plans charge increased premiums and co-pays to patients who don’t manage their illnesses effectively; others offer lower premiums for enrollees who follow wellness guidelines. Another company, HealthSpring from Tennessee, “is asking doctors at Sumner Medical Group…to coordinate with call-center nurses at American Healthways to keep closer tabs on 1,400 patients with chronic conditions like heart disease, diabetes, and asthma…The two [groups] coordinate efforts to reach out to patients and share information about scheduling and follow-up, as well as personal information about why a patient might be having trouble complying with medications, such as a death in the family or financial concerns about drug costs.” HealthSpring foots the bill for the call-center because the firm understands that a patient who remembers to take their cholesterol medicine regularly is a cheaper patient in the long run than one who winds up in a hospital intensive care ward with a heart attack.

By putting a price signal on generating better health outcomes - for both patients and physicians - public and private managers can leverage market forces, control costs, and save lives at the same time.

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Support for Drug Importation Varies
Washington Times, 3-9-05

Are you comfortable importing prescription drugs from Canada? How about Indonesia? Egypt?

A new poll has found that while “sixty-nine percent of Americans support importing prescription drugs from Canada”, “more than half oppose importing from other nations.”

The survey, released by the Polling Company, showed that while Americans trust their northern neighbor to send them medicines, 54 percent of respondents opposed importation from European Union countries, 41 percent from other European countries, and 41 percent from Asian countries.

Their most interesting finding was that senior citizens, “were the least likely of all survey respondents to support importing prescription drugs regardless of their origins.”

When Americans think about legalizing the importation of price-controlled medicines, they imagine surfing the Web and buying prescription drugs from a Canadian importer. In truth, Canadian importers can’t meet U.S. demand from Canadian supply alone. As more people turn to the Internet to purchase medicines, Canadian wholesalers will inevitably look farther and farther abroad to get more supply, creating tempting opportunities for drug counterfeiters and perhaps even terrorists.

The survey tells us that while importation may be popular in some quarters, its support is certainly hedged with a lot of caveats.

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Newer Therapies Lower Stroke Risk
Wall Street Journal, 3-9-05

A clinical trial funded by Pfizer but analyzed independently appears to show that patients with high-blood pressure are better off “taking a mix of newer drugs [which] may cut their risk of strokes by 25% and dangerous heart complications by 15% compared with [patients]” who take older (and cheaper) generic drugs called beta-blockers and diuretics. Patients on diuretics and beta blockers were also 30% more likely to develop diabetes.

The new drugs used in the study were Pfizer’s Norvasc (a calcium channel blocker) and Aceon (an ACE inhibitor), both designed to combat hypertension. One investigator who participated in the study said that the “[the] data will cause doctors to re-evaluate guidelines for using beta-blockers as first line treatments for hypertension.”

The battle between new drugs and old drugs illustrated above is, naturally, about both patient health - and money. Drug companies, of course, have incentives to maximize the sales of new drugs as old ones come off patent. Government bureaucrats, on the other hand, want to maximize the use of older, cheaper drugs to save money, even in cases where those drugs may be less effective or have more side effects than their newer counterparts. However, while insurers, government bureaucrats, and drug manufacturers haggle over formularies and prices, patient health must be the bottom line issue.

Thankfully, disputes like these will become largely obsolete in the future as more sophisticated diagnostic tests and datamining techniques - like the AmpliChip line made by Roche and clinical practice improvement studies - come online and allow physicians to more objectively determine the best treatment for each patient, whether it is a new drug, an old drug, or something else entirely.

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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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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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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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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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Eminent Domain Urged As Tool to Cut Drug Costs
Washington Post, 3-17-05

Editor’s Notes:

There is a proposal in the District of Columbia, according to The Washington Post, to have the city use “one of the government’s traditional powers [eminent domain]” to seize drug patents and transfer them to generic companies to produce the drugs the city buys for its public health care programs like Medicaid.

The Post says that “the issue propelling the bill is the skyrocketing expense of brand-name drugs. The country’s spending on prescription medicines has more than quadrupled since 1990, according to the Kaiser Family Foundation, and is on track to maintain double-digit increases annually through 2013.”

We would add that most of the increase in U.S. prescription drug spending is due not to drug-price inflation but to increased utilization of prescription drugs. In other words, drugs are enormously valuable medical tools, and we’re using more of them. If D.C. lashes out at pharmaceutical companies, by breaking patents, it will be cutting off its nose to spite its face.

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Company spent nearly 18 years developing drug; Amylin diabetes drug wins FDA approval - It's first new treatment since insulin introduced
The San Diego Union-Tribune, 3-17-05

Editor’s Notes:

As a side bar to the San Francisco Chronicle article on IVAX we discussed above, here is an article on another company’s tortuous odyssey to FDA approval for a new diabetes drug called Symlin.

Amylin Pharmaceuticals said yesterday that federal regulators have approved the use of its drug Symlin to treat diabetes, capping a drug development process that began almost 18 years ago. Symlin represents the first new drug for the treatment of diabetes since insulin was introduced in the 1920s. It also is San Diego-based Amylin’s first product to win clearance by the U.S. Food and Drug Administration…Amylin experienced a number of setbacks in its protracted quest to develop a new diabetes drug, which included clinical trials involving more than 5,300 people. The process required the company to raise $1.3 billion.
Until Symlin was approved, Amylin’s investors sunk millions of dollars into the company in the faith that one day - hopefully - they would produce a blockbuster drug. Amylin’s win is a victory both for its investors and for diabetics, who “just don’t get many new drugs.”

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State program debuts to assist with medications | Public linked to discounted, free drugs
The San Diego Union-Tribune, 3-17-05

Editor’s Notes:

The San Diego Tribune weighs in on California’s latest attempt to supply affordable prescription drugs to patients who may lack prescription-drug insurance. The plan, Rx Help for Californians, is “a new $10 million program sponsored by the pharmaceutical industry”, and “acts as a clearinghouse, providing individuals with access to more than 350 discount and assistance programs and 2,300 medications.” You can find an early evaluation of Rx Help by Sally Pipes here.

Despite the fact that “more than 60 patient and health care advocacy organizations support the program,” Rx Help is already drawing some criticism from consumer advocates who think that the state should “negotiate” directly with pharmaceutical companies for lower prices. “Negotiate” is, of course, just a code for government inflicted price controls. Legislators should carefully consider the impact of price controls on pharmaceutical R&D, and remember that mandating cheap drugs now will rob future patients of access to better medicines.

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Project FDA.


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