In the Spotlight
Faster Cures For the Future
Robert Goldberg, Ph.D., Medical Progress Today, 5-13-05
On April 21, the Milken Institute held its annual Global Conference in Los Angeles where I was able to meet, talk and mostly listen to many of the world’s best medical researchers, along with the investors who have bank rolled the genomic revolution.
Continue reading . . .
Test tells how much aspirin you need
Heart disease is one of America’s most deadly diseases, and low-dose aspirin therapy has become a popular treatment for preventing the platelet clotting that can cause heart attacks. But, as science advances, researchers have become aware that, like other drugs, different patients respond to aspirin very differently:
New research suggests that up to 27 percent of people taking aspirin may be resistant to it. Those most at risk for aspirin resistance include women, people over 65, diabetes patients and people taking less than 100 milligrams of aspirin. …More recently, doctors from Brigham and Women's Hospital in Boston reported that, for healthy women over 45, a low-dose aspirin (100 milligrams) every other day didn't seem to prevent heart attacks, although it did reduce their risk for stroke.
Thankfully, a quick and cheap blood test, called Verify Now, can tell patients whether low-dose aspirin is really helping them or just a placebo. Patients who are aspirin resistant can then talk to their doctors about taking a higher dose or switching to a different therapy.
Next Step Toward Digitized Health Records
Wall Street Journal, 5-9-05
Experts believe that developing digitized health-care records for patients will help providers coordinate care, reduce errors, and improve overall treatment. Physicians, however, face significant start-up costs for improving IT infrastructure—for instance, “entering mountains of bulging medical charts into computers.” Patient privacy concerns, competing technical standards, and sheer inertia are also slowing down the effort.
Still, one for-profit company associated with the American Medical Association hopes that it can spur consumer demand for electronic health-records:
Medem Inc., today plans to unveil an Internet-based "personal health record" that patients can use to organize their family's medical histories, much as they might electronically manage financial records or bank accounts. …the program helps patients record emergency contacts, insurance, and medical information such as conditions, medications and allergies. Patients access their record online using a password, and they can provide access to doctors, hospitals or loved ones: In case of an out-of-town emergency, for example, a husband could provide hospital staffers with his wife's password to ease treatment; patients seeking second and third opinions could provide their password to new doctors to get them quickly up to speed.
The records are available free at ihealthrecord.org and on some doctor’s Web sites.
As personalized medical treatments and diagnostics become more prevalent, consumer demand for electronic health records should take off. Eventually, EHRs will become as indispensable to consumers as credit cards—you won’t think of shopping for health care without one.
States and Employers Duel Over Health Care
The New York Times, 5-6-05
The New York Times chronicles a growing movement among state governments to “shift more of the burden” of providing health care coverage for the working poor from state Medicaid programs to employers.
…nearly two dozen states, struggling with the growing burden of providing public assistance to people with jobs but no insurance, are looking to shift more of the financial burden onto the workers’ employers. Last month, for example, Maryland, which spends roughly $350 billion a year on health care for the uninsured, passed a bill requiring the state’s very largest employers to spend at least 8 percent of their payrolls on health benefits for their workers. …
What the article doesn’t say is that states themselves are to blame for escalating insurance premiums and Medicaid budgets. State regulations mandating insurance benefits (for instance, chiropractic care) pass added costs to small and medium sized businesses through higher insurance premiums. As premiums rise, many small employers find themselves priced out of the market for even “basic” coverage. For instance, the Council for Affordable Healthcare Insurance found that:
…mandated benefits currently increase the cost of basic health insurance from a little less than 20% to more than 50%, depending on the state. Mandating benefits is like saying to someone in the market for a new car, if you can’t afford a Lexus loaded with options, you have to walk. …
States that offer expanded Medicaid eligibility through programs like Family Health Plus can also lure low-income workers out of private insurance markets because they charge lower premiums than employer-based coverage.
The bottom line result: state regulations push or pull more people into Medicaid programs, leaving taxpayers on the hook. Before state legislators lambaste employers like Wal-Mart for dumping health care costs onto taxpayers they should first heed the old adage: Physician, heal thyself.
HSAs More Than Double in Six Months, New AHIP Study Shows
America's Health Insurance Plans, 5-5-05
Health Savings Accounts are gaining market momentum just two years after they were created by the Medicare Modernization Act of 2003.
America’s Health Insurance Plans reports that, based on a survey of its members (“representing almost all the health insurance plans offering HSA-eligible plans”)
As of March 2005, 1,031,000 people were covered by HSA/HDHP products. This is more than double the HSA/HDHP coverage of 438,000 reported by AHIP members in September 2004.
Even more encouraging were AHIP’s findings that 37% of individual policies were purchased by formerly uninsured individuals; that 27% of policies in the small group market were sold to employers who didn’t previously offer coverage; and that “nearly half of people covered by HSA-eligible insurance are over the age of 40.” More information on HSA policies can be found at www.HSADecisions.org.
When it comes to health care there is no one “quick-fix” that will solve all of our problems. But, by making basic health insurance more affordable and putting some consumer skin in the game, high-deductible Health Savings Accounts can help to slow the growth of health care costs while still expanding insurance coverage.
New Drugs Aid Ethnic Patients In Varying Ways Drug Makers Find Ethnicity Affects Efficacy Cancer Drug, Deemed Failure, Helps Asians
Wall Street Journal, 5-5-05
FDA regulators and drug manufacturers are struggling to come to grips with the reality that new “targeted” drugs work more effectively for certain patient sub-populations than others. For instance, the cancer drug Iressa appeared to be a failure in post-marketing studies designed to confirm its efficacy—until data mining showed that it may work particularly well for some Asian cancer patients.
Iressa has proved effective at treating lung cancer in Asian patients, even as it has flopped in helping Caucasians, blacks and just about everybody else. Asians respond well to the therapy because they are more likely to have a certain genetic mutation in their cancer cells that Iressa is good at targeting, scientists believe. As a result, AstraZeneca, which initially planned on big sales of Iressa in the U.S., is now adjusting its marketing plan to focus on Japan, China and other Asian markets. For years, drug companies focused on finding drugs that could be sold to mass markets around the globe. Now, as researchers invent more precise treatments that target a particular genetic cause of a disease, drug companies are finding, sometimes unexpectedly, that their products work only on certain clusters of patients.
AstraZeneca is doing more research on Iressa to better understand how it works, and for whom.
Some commentators, in the meantime, have argued that targeted drugs won’t be as lucrative for industry as mass-market blockbusters. This may turn out to be the case for certain treatments that focus on very rare genetic conditions. But drugs like Iressa are proving that new indications for targeted drugs will undoubtedly be discovered as long as companies have powerful financial incentives to find them.
TAMING MEDICAID Taming NY's Medicaid beast NY taxpayers spend twice as much on Medicaid than those in the next closest state
Earlier we noted that state legislatures are eager to pass Medicaid costs to the private sector. Newsday
weighs in with a shrewd editorial that pinpoints the source of New York State’s burgeoning Medicaid program ($44 billion and climbing fast), along with some potential solutions:
New York's Medicaid bill is way out of line, compared to other states…its $44-billion annual cost exceeds spending on education, law enforcement, environmental protection, transportation and all social services. …
What most separates this state from the Medicaid pack is what it pays for hospital and nursing care. This is due largely to a tradition of delivering a disproportionate amount of care at costly, heavily regulated teaching hospitals. Market forces at work in other states have been slow to take here. Reimbursement rates and pay have been boosted beyond the national average by powerful trustees and union leaders who pool their clout to lobby lawmakers. This explains why the state's Medicaid spending has been well above others for years.
Newsday calls the naked emperor to account: New York’s legislators view Medicaid spending through the skewed lens of special interests. Until states face up to the real dynamics driving Medicaid spending, real reform will remain elusive.
FDA goes straight to press
Dr. Scott Gottlieb, USA Today, 5-11-05
Gottlieb worries that the FDA’s new approach to drug safety—quickly releasing public health advisories to the media when they become aware of potential problems—generates public anxiety before the risks are well understood or communicated to doctors.
No doubt, this approach is the agency's response to critics, but a press release is no place for a regulatory agency to flex its muscle. FDA is absorbed in an atmosphere that emphasizes managing drug risks over maximizing overall public health benefits. The agency's response to its critics is to move away from carefully tempered scientific statements made mostly on drug labels and through "Dear Doctor" letters and toward the bully pulpit. The agency is also issuing press releases that shine a spotlight on "emerging risks" rather than focusing on scientifically proven drug side effects. Critics eager to see a tough FDA may be assuaged by hard-talking headlines, but…shotgun warnings fall indiscriminately on both the right and wrong ears. …
All drugs have certain risks, so when regulators choose to highlight one in the press, it should be for good reason. Too much information, especially when it is poorly conceived or scientifically shaky, can be as bad as too little. Overstating a product's risk can discourage legitimate use, too.
Health Care Won't Solve Auto Woes
Tom Bray, New York Sun, 5-11-05
Thomas Bray takes on what he calls an urban legend: “that American manufacturers can’t compete because of high and rising health-care costs.” The Big Three automakers, for instance, cite retiree health care costs as one reason they are unable to meet foreign competition. The solution, proponents of this argument say, is to create a “national healthcare system of our very own.”
Bray points out that enlarging U.S. welfare entitlements (and taxes) would erode U.S. economic growth, as has happened in Europe and Japan. Finally, Bray argues that automakers have only themselves to blame for promising their employees platinum-health insurance at a fraction of its real cost:
For decades, union and management at big companies like General Motors have tried to create their own welfare states. Having failed, they now would like us to believe that what's needed is an even bigger welfare state. What's really needed is for American industry to face reality and stop making promises they - and nobody else - can keep.
Commentary: Prescription for Disaster; The District's proposal to regulate the price of drugs would hinder scientific progress.
Washington Post, 5-8-05
The Post weighs in on a topic we discussed last week: legislation passed by the D.C. City Council designed to ensure “reasonably priced” prescription drugs by threatening to steal drug patents from companies who resist the city’s strong arm tactics.
Under the guise of protecting the "public health and safety" of District residents, the D.C. Council passed a bill last week that would allow the District essentially to steal the patents for prescription drugs from pharmaceutical companies that do their own research and development and give them to generic drug manufacturers to produce the drugs at "lower costs" [Metro, May 4]. …
If the District wants to protect “public health and safety” of its residents, it should spend its money on health programs for its residents, such as a better emergency response system, expanded prenatal care and more accessible health clinics.
Wonder Land: From Spin City to Fat City
Daniel Henninger, Wall Street Journal, 5-6-05
Henninger uses our national obsession with “fat” (i.e., obesity) to make the point that public policy is often driven by scientific jingoism (like “preventable deaths”) rather than real science or even common sense.
The day the munching died is March 9, 2004, when the Journal of the American Medical Association gave its imprimatur to a study by the U.S. Centers for Disease Control [CDC], announcing that "obesity" had caused 400,000 deaths in 2000, a whopping 33% increase from 1990. …Within months, HHS said it might let Medicare pay for "anti-obesity interventions," suggesting obesity was now officially an illness, which in turn would pressure all insurers to pay for weight-loss "interventions."
Later, the CDC’s fat facts melted away. It turned out that the CDC’s math was seriously flawed and that “the new number of obesity-related deaths” was not 400,000 but 26,000. Henninger says this should be a cautionary tale for the media and elected officials: crying wolf over every intellectual fad reduces public attention to really serious problems that require sustained attention.
Center for the New Europe, 5-1-05
The Center for the New Europe highlights the findings of a study by the European Cancer Research Managers Forum (partly funded by the European Commission) that the gap between cancer research funding in the U.S. and E.U. is much larger than had been expected:
US per capita spending (17.63) is seven times that in the EU (2.56), and its spending as a percentage of gross domestic product is four times that in the EU. …
Gordon McVie, senior consultant to the European Institute of Oncology in Milan, described the findings as "a clarion call" to the European Commission…to increase its funding. "The survey shows that Europe is a second class continent in terms of cancer research funding." …
At least part of this gap can be explained by European restrictions on pricing and access to new medicines, even for cancer. Research talent and investment capital, consequently, follow the best returns on investment, which are found in the U.S.
Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?
Paul A. Offit, Health Affairs, 5-1-05
Vaccinations for preventable diseases are amongst the most cost-effective health expenditures a society can make. Why, then, has the number of vaccine manufacturers fallen steadily in recent decades, from “twenty six in 1967 to seventeen in 1980 and to five in 2004”.
Offit delivers an eloquent catalogue of the many disincentives plaguing vaccine production, from low prices in the federal Vaccines for Children Program to liability concerns. But two factors that deserve much more sustained discussion are the rising costs of regulatory compliance, and risk-aversion at the FDA:
The cost to develop and make many vaccines is greater than that to make most drugs, because products given to healthy people are often held to higher standards of safety than to those given to people who are sick. In 1998 the FDA licensed a vaccine to prevent rotavirus, a common cause of fever, vomiting, and diarrhea in young children. After the vaccine had been on the market for one year—and was given to about one million—children—the CDC detected a rare adverse event: About one of every 10,000 children who received the vaccine developed intussusception, a blockage of the intestine. As a consequence, the rotavirus vaccine was withdrawn. …
Following the withdrawal of the rotavirus vaccine in 1999, children have continued to be hospitalized for and killed by the rotavirus. Although many more children would have been helped by a rotavirus vaccine than hurt by it, the current culture does not allow for any serious side effects from a vaccine. …
New rotavirus vaccines are under development by Merck and GlaxoSmithkline, but in large and expensive “pre-licensure trials that include more than 140,000 children” and cost about $400 million. Other reforms are undoubtedly necessary to boost vaccine production—but one of the first things we should do is reassess the cost-effectiveness of regulations governing vaccine approval.
High Cost Medicare Beneficiaries
Congressional Budget Office, 5-1-05
Researchers and policymakers are hoping to rein in public and private health care costs by focusing on the relatively small number of patients with multiple chronic conditions who account for the vast majority of health care expenditures. This study by the CBO shows that this is, in principle, possible—but it is also probably very difficult.
For example, high-cost beneficiaries (those in the top 25 percent in terms of their spending) accounted for 85 percent of annual expenditures in 2001 and for 68 percent of five-year cumulative expenditures from 1997 to 2001. In addition, those high-cost beneficiaries, compared with beneficiaries in the bottom 75 percent in terms of their spending, were slightly older, more likely to suffer from chronic conditions, such as coronary artery disease and diabetes, and more likely to die in a given year.
The real challenge, however, is reliably identifying those beneficiaries and treating them in a way that saves money. Currently, the Centers for Medicare and Medicaid Services are running several demonstration projects on various strategies for reducing expenditures on high-cost beneficiaries, while still offering quality care. We’ll know more about what works—and what doesn’t—when those studies are completed.
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