|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 05-23-2006
AIDS Drug Trial Turned Away
Samuel Johnson is reputed to have observed that hell is paved with good intentions. The corollary to this should be "particularly the good intentions of activists." In this article, the Washington Post relates how AIDS activists have scuttled foreign trials of the AIDS drug tenofovir, which could—eventually—turn out to be the first successful drug prophylactic against the disease.
In the name of "protecting" prostitutes in poor nations from "Western imperialism" (by the Bill and Melinda Gates Foundation, those imperialists extraordinaire) activists have slowed efforts to find a treatment that could provide those same prostitutes with real protection.
On a Sunday afternoon in November, Yunang Soma stood shoulder-to-shoulder with other prostitutes on a makeshift stage in a park and shouted to the crowd: "The U.S. says it wants to help poor people, but it is killing the poor people!"
Perhaps the activists ought to have thought this one through a bit more. Unfortunately, righteous indignation and anti–corporate ideology seems to have overwhelmed their common sense.
Another quotation comes to mind in this case, this time from Juvenal: Quis custodiet ipsos custodes? Translation: Who guards the guardians?
Read the whole article.
Off label, off base? Many Drug Uses Don't Rest on Strong Science
This is a very interesting article on off–label drug use that is probably unduly alarming on the effects of off–label prescribing. Still, it is well worth reading for a window into the enormous complexity that doctors must grapple with in their attempts to help patients.
Every day in medical offices around the country, physicians hand patients prescriptions for drugs to treat conditions for which the medicines haven't been approved. Once a drug is approved by the Food and Drug Administration (FDA), a doctor can, with rare exceptions, legally prescribe it "off label": for use as he or she sees fit.
The article implies that what we really need is "rational drug use", i.e. treatment based on the "gold standard" for clinical evidence, the double blind placebo–controlled clinical trials often used for FDA approval.
The problem is that human complexity frustrates the attempt to determine how a given chemical will interact with an individual patient's particular genetic background and disease history. Even the best clinical trials tend to restrict enrollment to a very narrow class of patients for a very specific indication at a given dosage. Thus FDA approval, by its very nature, may tell us little about the full utility (or risks) of a drug at the time of its release.
This is neither the fault of the agency nor the industry. It is simply the state of our technology at the present time. Like it or not, the "real world" is where much of our knowledge about drugs will be gained.
For instance, even after a massive government-sponsored effort to study hormone replacement therapy in women, researchers and doctors are still debating the findings.
Advocating for the "rational" use of drugs may be fine in theory, but bad in practice. Until better diagnostic tests are available that can truly personalize routine medical decisions (and these are probably a long way off), physicians will be forced to use trial and error prescribing to help patients when known remedies fail.
The best short term solution to this problem is to improve postmarket drug monitoring through routine analysis of drug and patient databases used by large insurers and health care systems–not to call for larger and longer clinical trials, which may not tell us what we really need to know about drug treatments.
While we're all waiting for the next generation of personalized medicines, the best way to catch a glimpse of your own health future is to look carefully at your family history. This approach is also helping cancer researchers use new technologies to better understand the genetic roots of different cancers and help design treatments to fight them.
Scientists hope that by studying the DNA of patients in families where members across several generations get a particular cancer, they can home in on the genetic variations that make these families susceptible.
States begin overhaul of health insurance for the poor
One of the tipping points in the debate over welfare reform was the growing public consensus that welfare recipients had a responsibility to work in return for their benefits. A similar approach is now being applied in some state Medicaid programs, where policymakers are stipulating that poor Medicaid recipients "sign contracts" to abide by good health guidelines in return for certain types of health care coverage.
While some critics fear that this approach will lead to a decline in health benefits for the poor, this seems unlikely. No politician wants to be accused of denying healthcare to poor families. What it may do, however, is push poor recipients to use health care resources more conscientiously and become more proactive about staying in good health. While this is still a developing policy tool, it is one that should be studied carefully.
West Virginia's Medicaid families could face a reduction in benefits if they refuse to sign contracts promising to show up for doctors' appointments and use the emergency room only for emergencies. Kentucky, meanwhile, is putting new limits on prescriptions and visits to therapists.
Medicare Drug Benefit Viewed as a Work in Progress
The media is rife with speculation as to whether or not the new Medicare prescription drug benefit will wind up hurting or helping the Republicans come November. Knight–Ridder takes a wait and see approach:
The program's flaws and shortcomings were exposed early and often in the first few months after its January launch. However, recent news of lower–than–expected drug costs, patient satisfaction and a seemingly successful enrollment drive have given the program a new bounce that could help Republicans fend off future Democratic attacks.
Realistically, political arguments over the benefit may generate more heat than light. The press surrounding implementation of the benefit has been so relentlessly negative that beneficiaries have been pleasantly surprised by its actual performance. Indeed, opinion surveys thus far have found seniors who signed up for the benefit are saving money and are broadly satisfied with its performance.
Come November, however, other issues—Iraq, the economy, and energy prices—will occupy most voters' attention. For better or worse, Medicare Part D will likely amount to just so much background noise.
Having said that, the real battle over Medicare reform is still at least a year or two away, and that conflict will turn on whether or not seniors have become comfortable with the private management of the drug benefit and are willing to embrace more market driven reforms. In the interim, Democrats will do their best to strip the market elements out of Part D—i.e., adding drug price controls and setting a uniform national formulary. Advocates of market driven Medicare reforms are going to have to roll up their sleeves and start planning the next phase of reform.
To paraphrase John Paul Jones, when it comes to Medicare we have not yet begun to fight.
Study Finds drug benefit caps create unhealthy situation
Our public debate regarding the utility of prescription drugs is often schizophrenic. Take, for example, this article, which points out that caps on patient prescription drug spending often costs insurers more in overall health care spending because of "costly complications" that could've been prevented by appropriate drug treatment.
Placing caps on prescription drug benefits might not actually save insurers money because patients don't take needed medications and often suffer costly complications, according to a study of Medicare beneficiaries published today in the New England Journal of Medicine.
Ironically, after presenting data on the cost–effectiveness of prescription drugs, the article goes on to quote an expert who argues that Medicare ought to "negotiate" drug prices directly with manufacturers.
First of all, the government's market leverage and incentives tend towards price controls and other non–price restrictions on drug use—like mandating the use of generics and restricting access to new medicines. In any event, this would amount to a de facto cap on access to many medicines.
A more rational response would be to pay a premium for treatments—prescriptions drugs or anything else—that reduced illness and total health care costs, instead of limiting spending across the board. Pay for performance would help lower drug spending without punishing the very companies driving medical innovation.
Ultimately, shifting to an outcomes–based payment system would benefit the most efficient health care providers and improve patient care. That won't happen, however, until we end our irrational fixation with controlling line item costs.
FDA clears a generic biotech drug
The Globe reports that the FDA reached an important milestone last week when it approved the first so-called biogeneric drug. It is hoped that, like traditional generics, copies of biotech drugs whose patents have expired will offer patients and providers cheap alternatives for lifesaving medicines.
The Food and Drug Administration yesterday approved a generic human growth hormone, a breakthrough that allows its maker to sell its first copy of a biotechnology product in the United States.
Despite this milestone, much work still has to be done before the FDA has an official approval process for biogenerics. The debate is proceeding slowly because of conflicting arguments over what data should be required to prove that biogenerics are really equivalent to the original products.
Still, this is ultimately a manufacturing question that the FDA should be able to surmount once the underlying technical questions have been resolved. While biotech companies are leery of generic competition, it is in their best interests to work with biogeneric companies to establish a reliable and fair process for biogeneric approvals. Until then, the lack of such a process will only hurt the industry as consumer resentment mounts over the rising cost of biotech treatments.
In short, it is important to strike the right balance between innovation and pricing, and the biotech industry should be proactive about finding that balance.
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