|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 11-29-2004
Novel Vaccine Activates HIV Immunity, Slows AIDS Virus
To date, AIDS vaccine development has been a tale of great hopes followed by crushing failures.
However, one experimental vaccine has shown preliminary effectiveness in human beings after being studied in mice and monkeys. The so called “designer” vaccine is created by extracting cells from an AIDS patient’s own immune system and HIV isolated from the patient’s blood. The immune cells are then “loaded” with pre-killed HIV viruses and reinjected into the patient, helping to activate a powerful immune response against the virus.
Patients in one small study who received the designer vaccine saw their viral loads drop by 80%. “After a year, eight of the 18 patients still had a 90% drop in HIV levels”, and T cell counts in all the patients had stabilized. Researchers involved in the project warn that their study is only a “proof of principle”, and that randomized clinical trials will be required to prove efficacy. Still, a ray of hope is better than none at all.
When it comes to cancer, many physicians are reconsidering the entire concept of what constitutes an “untreatable disease”. New targeted radiation and chemotherapy treatments have made cancer therapy more bearable, even as clinical evidence suggests that many patients can bear more radiation exposure than had been previously thought possible.
“The shift is largely being driven by new thinking among doctors about how much radiation a person can stand, and by technology that makes it possible to deliver treatment straight to a tumor and spare surrounding organs. Previously inoperable tumors in the lungs, liver, head and neck can now be isolated, shrunk, and then removed using minimally invasive surgical techniques.”
Of course, there is always the question of whether the pursuit of treatment in a terminally ill patient will merely prolong suffering, but a wide range of new medicines and technologies are giving patients with advanced cancer a fighting chance that they never had before.
UPDATE: 2-Cipla anti-AIDS drugs back on WHO approved list.
The WHO has reinstated two generic AIDS medicines formerly withdrawn by the Indian company Cipla, six months after they were first removed when concerns surfaced regarding the quality of data Cipla had submitted to prove that its drugs were equivalent to patented medicines. “The life-extending drugs are back on the list of WHO-approved products after fresh inspection proved they were equivalent to their patented counterparts, the United Nations agency said, pledging continued ‘rigorous assessment and monitoring’ of anti-AIDS drugs known as retrovirals.”
A total of 28 Indian generic AIDS drugs were on the WHO list as of early last summer. Since then, 18 have been removed, 2 were reinstated, and 16 remain delisted. Dr. Roger Bate, a Fellow at the American Enterprise Institute, thinks that the WHO is focused more on meeting treatment quotas than ensuring that generic anti-retroviral drugs (ARVs) perform as advertised.
Dr. Bate says that “in its attempt to see others treat three million HIV patients by the end of next year, The World Health Organization has cut corners on the quality of medicines it approves. The latest re-instatement of two Cipla ARVs, previously withdrawn over the summer, and after 16 other Indian copy drugs have been withdrawn in the past 6 months, points to an honor system that is so flawed that one wonders at the quality of the drugs that remain on the pre-qualification list. The WHO should scrap its pre-qualification process and take the FDA up on its offer to test all ARVs for bioequivalence. Only then will we know which drugs actually work. Let us be clear, this is an issue of safety - if the drugs do not work properly then patients will die.”
No Relief Seen In the Growth Of Employers' Health Costs
Through the first two quarters of 2004, health care costs rose at about the same rate as in 2003, 7.5 percent. The growth was “largely driven by the growth in hospital costs,” “both for overnight stays and outpatients,” along with new hospital construction. This has led some industry observers to the belief that shifting more responsibility for health care spending to consumers won’t have much effect on overall cost trends.
Exactly how they come to this conclusion isn’t stated, so we’re left to guess. But the upshot is that the only force capable of moderating health care spending is the federal government, presumably through universal insurance coverage combined with price caps. This may cut costs, but not accomplish much else – rationing health care leads to reductions in health care quality and access that drives overall societal costs up, not down.
Michael Porter, director of the Institute for Strategy and Competitiveness at Harvard University, puts the problem this way: competition in health care is at the wrong level. Everyone – insurers, physicians, providers, etc. – competes on the basis of cost, not quality or efficiency. Overall, the system “wrangles over the wrong things, in the wrong locations, and at the wrong times. System participants divide value instead of creating it....[stakeholders] shift costs onto one another, restrict access to care, stifle innovation, and hoard information - all without truly benefiting patients.” Government control over health care would merely amplify the current emphasis on cost controls and crowd out incentives for innovation and efficiency.
Health care may never be cheap, but before we give up on the market, we might try having one first. Cost pressures and competition in every other industry drives innovation and efficiency that result in better outcomes for consumers. However, health care remains one of the few industries where bad outcomes are rewarded without batting an eye. Until this changes, and health care providers directly compete for customer dollars based on quality, our national obsession will remain health care costs, which is the wrong outcome to measure.
U.S. drug safety system shaky, experts say; Recently, troubling news about several high-profile drugs has sapped confidence in the system charged with exposing dangerous medicines.
According to a 2001 report from the national Institute of Medicine, approximately 100,000 people die every year due from preventable medical errors. Does this mean that America’s physicians are evil, greedy, unrepentant killers?
No, but it does seem to be the attitude engendered towards the pharmaceutical industry in the wake of Vioxx’s market withdrawal and other high-profile safety issues at the FDA (pediatric anti-depressants, Baycol, and the flu vaccine shortage).
Some pause for rational reflection would seem to be in order. We need to remember that adolescent suicide has been in a decade-long decline, even as prescriptions for anti-depressants have risen dramatically. Rates for cancer, stroke, and heart disease mortality have all fallen since the early 1990s, when the FDA allegedly was scooped up into the pocket of the pharmaceutical industry and released a flood of unsafe drugs into the nation’s medicine chest.
Is the nation’s drug safety system in need of an upgrade? Yes, but let’s keep the problem in perspective: Americans have access to more of the world’s new drug launches than any other nation, and benefit from that both in terms of health outcomes and economic growth. Instituting a jihad against industry and the FDA is unmerited based on the facts and will have real consequences as valuable new drugs are kept off the market longer or are scrapped altogether by risk-averse FDA regulators.
Safety – in terms of medical errors or prescription drugs – means creating a system wherein the right incentives are aligned for both providers and consumers, and health care information is divulged and shared among providers in a timely fashion. That is, basically, a structural problem, not a fatal flaw in the way we approve and market new medicines. Let’s concentrate on fixing the real problems rather than making political hay with misguided corporation-bashing.
Americans Relying More on Prescription Drugs, Report Says
This is true, but it is also true that life-expectancy is climbing (to 77.3 years, a record), and there are continuing declines in heart disease, cancer, and stroke – the nation’s leading causes of mortality.
Overall, “more than 40 percent of Americans take at least one prescription drug, and 17 percent take three or more.” Americans are also spending more on health care across the board – up 9.3 percent in 2002 – but any anxiety over cost has to be offset by the improvements in many health categories. The question is, how much bang is the nation receiving for its health care buck? Assuredly there is some waste in the system, but there are also many diseases that are, by most clinical standards, undertreated. Studies consistently show that increased spending on pharmaceutical innovation generate returns to society that far outweigh their costs.
Even so, we are only at the very first stages of new technologicial developments that will allow us to deliver health care more efficiently and effectively on an individual basis. Empowering consumers to spend their own health care dollars would help to accelerate this revolution and remove the unease that now surrounds prescription drug spending.
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