|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 01-31-2005
Nanomedicine's Promise Is Anything but Tiny
Nanotechnology—the study and art of manipulating matter on a molecular or atomic scale—will redefine medicine in the coming decades, as diseases are cured or prevented by tiny devices and medicines that repair the human body at the cellular level.
For the time being, nanomedicine is more science fiction than science fact, but there have been some very promising early developments. For instance, researchers are using “quantum dots” (tiny bits of silicon, 2-billionths of a meter long) as “research tools to help them understand how proteins, DNA and other biological molecules catch rides on the various transportation systems inside cells” and to help diagnose disease at the molecular level.
Other “nano” devices may be used for cancer treatment—for instance “photo-thermal nano-shells…gold coated spheres about 130 nanometers in diameter.” These spheres are great at absorbing infrared light that penetrates the human body but is harmless under normal circumstances. However, researchers found that when they infused the nanospheres into mice with cancer, the spheres accumulated around tumors and, when bombarded with infrared light, heated up to 122 degrees—effectively cooking the tumors and killing them. “Months later, the animals were still cancer free.”
The promise of nanotechnology is enormous—but can we embrace it? Currently, the FDA is struggling to develop protocols for tracking traditional drugs, in traditional settings—let alone cutting edge forms of nanotechnology or genetic medicine. Making the leap into the 21st century will require enormous imagination and flexibility from an agency that faces ruthless criticism every time it does something flexible or original.
Every year, millions of patients will develop serious infections during their treatment in U.S. hospitals, according to the CDC. “It says that these may lead to nearly 90,000 deaths annually—more than the toll from breast cancer or car crashes. Hospital-acquired infections add roughly $5 billion a year to the cost of patient care in the U.S., according to a study in the American Journal of Infection Control in 2002.”
As a result, there is a growing movement to require hospitals to disclose their infection rates and “laws requiring hospitals to compile and publish their infection rates have recently passed in Pennsylvania, Illinois, Florida…and Missouri.”
Requiring hospitals to publish standardized, risk-adjusted infection rates in a transparent medium would give patients and the physicians who refer them for hospital treatment the ability to avoid bad performers and demand more safety procedures to ward off infection. The CDC is helping with this effort and is trying build consensus on a national infection reporting program—and may use as a model New York State’s successful experience “reporting on hospitals’ mortality rates in coronary-artery bypasses.”
Of course, some hospitals would prefer to keep such information private, out of fear of lawsuits, or because they are worried that they will be penalized for taking hard to treat patients, who may be at very high risk of infection (like, say, AIDS patients).
But it is possible to adjust reporting laws to take these issues into account and empower consumers to demand safety reforms.
The consumer advocate group Public Citizen has recently accused drug giant Pfizer—and Pfizer’s former partner, Pharmacia—of hiding data from a 1999 study that associated Pfizer’s COX-2 drug Celebrex with an elevated risk of “heart attacks and other cardiovascular side effects.” The 1999 clinical trial was only recently posted on a clinical trial’s website.
Still, the initial furor around the study seems to be more about the failure to publish the study sooner than any link between Celebrex and heart disease. According to one of the safety-board members who oversaw the trial, “The Public Citizen analysis was flawed…because it lumped together side effects that could have different causes. In some cases…the same patient might have been counted more than once as well. And it happened by chance that the patients in the Celebrex groups were sicker overall than those in the placebo group.”
Still, this is one more argument that the industry badly needs to regain public trust by doing more to encourage rapid disclosure of significant clinical trials, no matter what the results. The absence of transparency (or even a voluntary system) is sure to invite skepticism and suspicion when companies are least able to afford it. After all, the time to protect your reputation is before a crisis—not after one develops.
An Injection May Stall Lymphoma
A new antibody-based drug called Bexxar is generating excitement as a potential new treatment for follicular non-Hodgkins lymphoma, the second most common type of that cancer. “Overall, about 20,000 Americans die from non-Hodgkins lymphoma annually, according to the Leukemia and Lymphoma Society.”
Bexxar is a targeted cancer treatment of a variety called immunotoxins, which use antibodies to identify and latch onto diseased cells in order to deliver a fatal dose of medicine - in this case radioactive iodine, which kills cancer cells.
In the study reported in this article, Bexxar was injected into 76 patients with late stage follicular lymphoma (which is often fatal) during a weeklong course of treatment. University of Michigan researchers, who developed Bexxar, reported that “95% of the patients responded to treatment with Bexxar and that 75% - or 57 patients - had a complete response or effectively had their cancer cured. So far, 40 patients have remained disease free after at least 5 years.”
F.D.A. May Approve an Implant as a Treatment for Depression
The FDA is considering approval of an implantable electronic “pacemaker for the brain” to treat patients with depression that aren’t responding to other therapies. The FDA has asked Cyberonics, the manufacturer, to meet a number of conditions prior to tentative approval, but the company thinks it could meet the FDA requirements May 2005.
“The device…is the size of a pocket watch, is implanted in the upper chest and connected via thin wires to the vagus nerves in the neck. It sends pulses through the nerves into parts of the brain associated with the diseases being treated.”
As many as 4.4 million Americans have treatment-resistant depression that could respond to this device. The FDA committee that recommended approval did so because these patients have run out of other options and are considered a very high suicide risk.
NIH Grant Recipients Are 'Asked' to Post Data New Policy on 'Public Access' Draws Criticism
The first rule of medicine is “do no harm.” The first rule of government policymakers is “when in doubt, regulate.”
The NIH has reacted to Congressional criticism over employees who had not disclosed their contracts with industry by instituting draconian ethics rules. The rules have elicited a firestorm of protest from NIH staffers that will probably “have ripple effects on NIH’s ability to recruit and retain talent for years to come.”
At a “town hall” meeting recently with NIH employees, NIH Director Elias Zerhouni faced fierce criticism over the new guidelines - especially one requiring “thousands of employees” (including their spouses and dependents) “to divest themselves of all stock holdings in drug, biotech, and other medically oriented companies.” Even low-level staffers with no influence over NIH grants or policy will have their investments capped at $15,000. Another rule that drew outrage forbids employees from accepting stipends associated with “the vast majority of scientific and public service awards.”
When government surrounds itself with a thicket of impenetrable rules to ward off corruption it inevitably hamstrings the effectiveness of public institutions. In the biotech and pharmaceutical sectors, close collaboration between academia, government, and industry is not only natural - it is necessary. Sharply restricting researchers ability to consult with private industry will only hinder the NIH’s ability to recruit and retain the best talent and chill the working relationship between industry and government.
10-year goal: Help millions more get health insurance
The nation is facing a massive crisis in Medicaid spending and the Bush administration is proposing to spend $140 billion to get more Americans access to health insurance, if it can offset that with $60 billion in savings for Medicaid.
“The administration’s proposed savings would come from stopping what it says are accounting tricks that states use to get more federal Medicaid funds, making lower payments for prescription drugs and tightening rules to keep seniors from giving away assets in order to qualify for the program.”
The administration's proposal would use tax credits to help low-income Americans buy their own health insurance, as many as 12-14 million more over 10 years. This would allow the government to get out of the business of managing Medicaid benefits, which it does very badly. Insurers would have more ability to offer a rational package of benefits at an affordable price, and Medicaid beneficiaries could escape from the program’s onerous regulations.
Glaxo Drug Quickly Suppresses HIV in a Human Clinical Trial
Researchers note that a GlaxoSmithKline drug given “fast track” status by the FDA has shown promising results in an early clinical trial and “suppressed blood levels of the AIDS virus in 31 patients by about 98% after just 10 days of treatment.” The drug, called by the charming name 873140, “blocks entry of the AIDS virus into human cells” via what is known as a CCR5 receptor, one of the cellular “doorways” the virus uses to enter human cells.
Researchers were excited by the early findings, and pointed out that “the agility of the AIDS virus in developing resistance to existing types of AIDS drugs makes new classes of drugs [like this one] ‘absolutely critical.”
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