In the Spotlight
The War on Carcinogens vs. The War on Cancer
How misuse of animal tests and the war on "carcinogens" hurts America.
Elizabeth Whelan, Center for Medical Progress, 3-11-05
One might argue that America is losing the War Against Cancer by conducting a War on "Carcinogens."
A thicket of current federal and state laws and regulations (including Superfund, Prop 65 in California, and EPA and FDA regulation of pesticides and food additives) assume that a rodent is a little man. Such laws cause substantial disruption of our nation's economic productivity (including inducing fear of safe foods and removal of safe consumer products) by banning any chemical that at high doses causes cancer in animals, as though it were necessarily a carcinogen for humans as well. This knee-jerk practice - based on no epidemiological evidence using human data - represents a threat not only to our quality of life - but also to our very lives and health.
Continue reading . . .
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.
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.
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.
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.
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.
Drug blocks cravings
Chicago Tribune, 3-6-05
Eat less. Quit smoking. Cut back on the drinking. Sound too good to be true?
“Acomplia, a drug soon to be submitted for Food and Drug Administration approval, could help by effectively blocking [cravings that lead to over eating or smoking]. Even better, there’s promise that it can help people stop smoking and possibly curb alcohol abuse…”
Patients in clinical trials taking Acomplia “lost an average of 20 pounds in a year as well as 3 inches off their waists. In addition, their HDL (good) cholesterol rose about 25 percent. Twice as many smokers were able to quit as those who tried quitting without taking Acomplia, and they did so without gaining weight.” The NIH is planning a trial to see if Acomplia can help reduce alcohol abuse.
This drug, if approved, will have enormous appeal to physicians and patients. But do we have the right safety procedures at the FDA to ensure that it is used as effectively and safely as possible?
Now is the time for the FDA and industry to focus on making sure that “blockbuster” drugs like Acomplia come equipped with the underlying diagnostics and safety monitoring tools to prevent another Vioxx-like scandal.
A scan - but not as we know it: The AmpliChip, a revolutionary breakthrough in genetic diagnostics, has brought 'Star Trek' medicine a step closer
Financial Times, 3-4-05
Its always easy to overstate the benefits of new technology, but in this case the hype is probably well deserved.
“In January, Roche, the Swiss drugs and diagnostics group, and Affymetrix, a US genetics company, announced US regulatory approval for the first market application for their revolutionary AmpliChip diagnostics technology…Simply put, the [AmpliChip] uses breakthroughs in genetics to isolate individual genes – called bio-markers – uniquely identified with certain medical conditions. Crucial parts of the genes are replicated to make them usable for diagnostic purposes.”
The first chip sounds like a Star Wars robot - CYP450 - but it will help doctors gauge patient sensitivity to a “to a wide range of commonly prescribed drugs.” Now that the basic technology behind the AmpliChip has been mastered, other similar chips will follow that build and improve the same design. For instance, AmpliChip P53 will provide “a cancer test to determine how aggressively a tumor may grow” and consequently what kinds of treatments should be brought to bear by physicians.
Roche is at the cutting edge of medical progress because it is creating the diagnostic tests that will drive drug development over the coming decades. After all, if you understand and can effectively test for biomarkers for diseases like cancer or Alzheimer’s you can use that knowledge to improve drug development and then guarantee effectiveness - and reimbursement - once your products are launched.
Warning for Cholesterol Drug
Wall Street Journal, 3-3-05
The FDA is adding a warning label to the statin drug Crestor “that starter doses should be reduced in Asian-Americans and some other patients.” Crestor, like other statin drugs, can lead to a serious, even potentially fatal, muscle wasting condition. However, one clinical trial has turned up specific evidence that “levels of Crestor in Asian patients were double those of Caucasians taking the same dose, increasing the chance of muscle damage.”
“The new label urges physicians to start Asian patients, those with severe kidney disease, and patients taking cyclosporine at the lowest dose level. The lowest available dose would be five milligrams, compared with a maximum dose of 40 milligrams.”
Now, imagine that you are a doctor with a access to one of Roche’s AmpliChips. You can measure how your patients will metabolize statins like Crestor, and change dosages and drugs depending on the results. That’s better than any warning label the FDA can supply on a package insert.
Administration considers pay-for-performance for Medicare providers
Associated Press Newswires, 3-2-05
As we noted earlier in our discussion of patient compliance, offering financial incentives for better disease management is getting a lot of attention in the health care world, particularly in government programs trying to stretch their limited health care budgets just a bit farther.
This charge is being led by Medicare Administrator Mark McClellan as “the Bush administration [overhauls] the way it reimburses Medicare providers by financially rewarding those who meet certain standards and punishing those who don’t.”
This may, of course, seem like a radical idea, until you remember that this is the way businesses that actually have set budgets work. Suppliers who meet their contracts get more business. Those who don’t will see their funding streams slashed or be replaced by firms that can provide better quality services.
Medicare’s enormous and rapidly growing budget is, of course, a prime target for pay-for-performance measures, and demonstration projects are already underway that are testing how effectively they work. While performance pay might not slow spending, McClellan is confident that “a change in reimbursement methods would have the potential to affect the bottom line for health care providers” and giving them real incentives to improve quality - which in this case, means patient health.
Health Policy on a Budget
Joseph R. Antos, Ph.D., Health Policy Outlook, American Enterprise Institute, 3-10-05
Antos says that mounting federal Medicare outlays are a “hot potato [that] has landed squarely in the lap of Congress, and we can only hope that it does not drop it. The president’s major objectives - to cut the deficit in half over the next four years, reduce taxes, and reform Social Security - require an extraordinary degree of political cooperation on Capitol Hill and willingness to make hard calls on where to reduce federal outlays.”
While the media have focused on the costs of the drug benefit and demands from some sectors for the government to “negotiate” (translation: set prices) with drug manufacturers, the reality is that “even without the drug benefit, Medicare would face a $45 trillion obligation that would have to be paid over and above the revenues that are specifically earmarked for the program. Consequently, the political focus on setting drug prices misses a larger point: Medicare’s fiscal crisis is a product of its own design, not solely the result of adding an expensive new benefit. Until we come to grips with the defects of a program that rewards providers for more services, not more results, we will see unnecessary costs mount inexorably.”
Weight Loss Maintained With Rimonabant After Two Years
Rimonabant is the active ingredient in Acomplia, the weight reduction/smoking cessation drug mentioned earlier. This article describes the latest clinical trial findings demonstrating its potential for long term weight control.
“After two years of treatment with rimonabant, a novel endocannabinoid inhibitor, overweight and obese patients were able to maintain weight loss and reductions in waist circumference, a finding that paves the way for Sanofi-Aventis to file for the drug’s approval by the U.S. Food and Drug Administration by July of this year…Participants in the study were randomized to either low-dose (5 mg) or high-dose (20 mg) rimonabant or placebo. All patients were told to reduce their daily caloric intake by 600 calories, but they were not given any specific dietary guidelines, nor were they given recommendations about exercise…after two years patients receiving the 20-mg dose of rimonabant had maintained a 7.2-kg weight loss compared with a 2.5-kg loss among patients receiving placebo.”
Acomplia was developed based on the interesting observation that smoking pot (cannabis) spurs the “munchies”, i.e. it makes people hungry. Researchers theorized that if the same chemicals (cannabinoids) that spiked appetite in the brain could be blocked from their receptors, patients would experience fewer hunger pangs and lose weight. So far, their bet appears to be paying off.
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