In the Spotlight
A limited solution for a limited problem.
California’s program for affordable prescription drugs.
Sally C. Pipes, Center for Medical Progress, 2-10-05
California Governor Arnold Schwarzenegger is taking on one of the year’s highest profile public policy issues - the affordability of prescription drugs for people with limited means and who lack prescription coverage.
Unlike other politicians who need publicity stunts to catch the media’s attention, Arnold did not bother with the seductive but ultimately empty idea of using taxpayer money to encourage Californians to break federal law and endanger their health by importing drugs from foreign countries. Instead, the governor proposes a plan that would target Californians in need of less expensive medicines without spending millions of taxpayer dollars and creating a whole new bureaucracy. If Arnold is successful, he will have created a program for other governors to emulate.
Continue reading . . .
Pharma Prophet: Garret FitzGerald saw the Cox-2 debacle coming. Now he sees the drugs' salvation.
Garret FitzGerald began voicing concerns about COX-2 inhibitors shortly after Merck introduced its COX-2 drug Vioxx in 1999, and has kept up his criticisms of the drugs ever since - that is, until now. Today FitzGerald believes that the drugs should remain on market, provided that they can be modified or targeted at patients who truly need them.
“A handful of drug companies, including Merck, Ono Pharmaceutical and France’s Servier, are now working with FitzGerald…to unearth successors to the now-disgraced COX-2 class of painkillers.”
FitzGerald thinks that the problem with COX-2 inhibitors was that they were aimed at the wrong target. The COX-2 enzyme is actually the precursor for a wide ranging group of “biochemical signals” called prostaglandins that the body needs. One of the prostaglandins, called prostacylcin, actually protects the heart.
FitzGerald hopes that “If drug developers could better target their inhibitors farther down the prostaglandin chain, they might produce powerful drugs that could fight pain and avoid unknown, possibly fatal, side effects.” He hopes that further research could even lead to blood tests that would measure prostaglandin levels and allow doctors to predict which patients can take COX-2 drugs safely. “We have to find a way to use these drugs chronically in people at low cardiovascular risk but high risk of stomach problems. They’re going to be a nice case of individualized medicine.”
FitzGerald is right—and diagnostic tests like these will revolutionize drug development, patient treatment and FDA regulation. After all, current clinical models are based on the “one size fits all” dosage model that presumes that adverse drug effects are basically random and largely unpreventable. In a world of personalized medicine, drugs will increasingly be developed using biomarkers for specific patient profiles that allow doctors to maximize efficacy and eliminate the worst adverse effects.
Health Group offers remedy to businesses; A coalition is moving into South Florida to increase healthcare quality and lower costs for large employers
The Miami Herald, 2-8-05
A group of South Florida’s largest employers has joined forces with a 21 year-old Orlando-based employer coalition to form the Florida Health Care Coalition, which will push for improved health care quality and lower costs for their employees and dependents.
Driving the merger are South Florida’s enormous health care costs, among the highest in the nation. “Studies of Medicare data by Dartmouth researchers show that the average senior in the region costs Medicare almost twice as much as a senior in Minneapolis. Private health plans report similar differences.”
According to some estimates, the Orlando-based coalition (formerly the Central Florida Health Care Coalition) saves its members $50 million every year in hospital costs alone. Orange County Public Schools, one of its members, has used its savings to hire 50 new teachers. The Coalition’s tactic is “to gather data on healthcare trends and prices, determine the best scientifically based standards for quality care and then work quietly with providers to make changes.”
Cost isn’t the only factor. The coalition is acutely aware that “discounts [don’t] heal patients.” Better health care does. For instance, hospital data for obstetricians at one Central Florida practice showed a spike in cesarean sections on Fridays - perhaps because doctors didn’t want to work weekends. The coalition brought the anomaly to the attention of the practice group and their C-section rates dropped.
Their solution is as simple as it is elegant. “When people know they are being watched, their behavior changes…So much of this is just common sense.”
Novartis Weighs Cap on Prexige Use: Company May Seek Limits On FDA Approval, at First, To Study Effects on Heart
Wall Street Journal, 2-7-05
What do you do when you have a treatment with known benefits and some unknown risks? Novartis is asking itself this question as it considers applying for FDA “limited initial approval” for its new COX-2 painkiller. Limited approval would restrict the drugs use to a narrow group of patients until the drug builds up a proven safety track record.
Prexige is in the same class of drugs (COX-2 inhibitors) as the drug Vioxx, which was withdrawn from the market after it showed an increased risk for heart attacks and strokes. Will Prexige exhibit the same risk profile?
Novartis conducted its own 52-week study on Prexige in 18,000 patients with osteoarthritis. The study followed the number of gastrointestinal injuries in patients taking Prexige compared to ibuprofen and naproxen, two older and much cheaper painkillers that are known to cause potentially dangerous stomach disorders. The study found that Prexige was easier on the stomach, but Novartis didn’t have enough data to completely rule out any increased risk of heart attacks and stroke.
By asking the FDA for limited approval “only for pain sufferers with serious gastrointestinal problems who need a painkiller that won’t aggravate the stomach” Prexige would be allowed on market and could become a real boon for these patients. It could then accumulate safety data that Novartis could use to make the case for additional indications.
While this approach is no substitute for the development of personalized medicine, in this case it may be the best way for industry and the FDA to balance safety and risk without stifling medical progress.
Power tools for the gene age ; New test can help doctors in prescribing medications
The San Francisco Chronicle, 2-7-05
Gene chips - small wafers of glass or nylon that are coated with DNA - are a technology that can be used to help doctors view the genetic profiles of their patients and prescribe medicines that match the profile.
“[Gene chips will soon allow doctors] to order a test to find out whether patients have unusual gene variations that predict whether they’ll suffer bad reactions to certain drugs. The diagnostic chip can reveal whether patients clear drugs from their systems too quickly or too slowly. Too fast and the normal dose is too low to do much good. Too slow, and the drug builds up in the bloodstream at potentially dangerous levels.”
The device, AmpliChip CYP450 “is the first diagnostic test approved by the Food and Drug Administration that belongs to the class of gene-scanning tools called DNA microarrays.”
Hopefully, AmpliChip is only the vanguard of many new gene tests that will allow doctors and their patients to turn drug therapy from guesswork into a true science.
Internet pharmacies forced to open shop overseas; Concerned about Ottawa crackdown
The Globe and Mail, 2-7-05
As Canadian policymakers edge towards restricting Internet drug exports from their country into the U.S., Internet pharmacies are looking far and wide for ways around the ban.
And we do mean far and wide. One Internet pharmacy group imports drugs from over 30 countries to meet the demand for 10,000 prescriptions a week from American customers.
Still, Canadian exporters are concerned that eventually competitors from Europe, Asia, and Latin America will skip the middlemen and market their wares directly to Americans.
This raises questions about the safety of prescriptions purchased over the Internet - which is basically open to all comers. Purchasing drugs from directly from Canada is one thing, but widely expanding the pool of Internet imports to meet U.S. demand makes it impossible to effectively regulate the industry.
Are the Canadians likely to become the sole supplier for American drugs? Not at all. There just isn’t enough Canadian supply. The Canadian Health Minister has himself said that Canada’s Internet drug industry “is based on a false economy and on a price differential that was created for the benefit of Canadians and not for the consumption of Americans.” The real question is how long it will take Americans to recognize that fact.
F.D.A. May Approve an Implant as a Treatment for Depression
The New York Times, 2-4-05
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
Washington Post, 2-4-05
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
USA Today, 2-4-05
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.
An Injection May Stall Lymphoma
Wall Street Journal, 2-3-05
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.”
Free the Scientists! Conflict-of-interest rules purport to cure a problem that doesn't exist - and are stifling medical progress.
Dr. Stossel takes issues with the recently enacted NIH restrictions on employees accepting funding from or taking a financial stake in companies in the health care sector.
“The theory behind the rules is that a financial interest causes an academic scientist to lose objectivity and report biased facts. In the real world, however, these restrictions address nearly nonexistent scientific corruption and ultimately impede medical progress by depriving pharmaceutical companies of access to biomedical scholars.”
Dr. Stossel believes that such private-public collaborations have been “overwhelmingly beneficial” and that the bias against such relationships is just that—a bias. “Editors of high-profile medical journals vilify the pharmaceutical industry, provide forums for antibusiness tactics, tout theoretical evils of conflict-of-interest and promote an idealized view of research. The ideological commentaries appear side by side with peer-reviewed scientific reports, thus carrying the weight of objective truth to reporters and to the public.”
Medicaid needs Surgery
David Gratzer, The Weekly Standard, 2-14-05
Gratzer, a senior fellow at the Manhattan Institute, notes that President Bush is facing a steep uphill climb in his drive to limit federal contributions to Medicaid. Although the administration is floating the idea of giving more flexibility to the states in return for a hard cap on federal contributions, state governors and even some Republican Senators are aghast at the idea that the flood of federal funding might slow even a little.
Why? “The basic problem with Medicaid is that Washington foots the bulk of the bill, yet most of the administrative decisions are made at the state level…For every three dollars worth of new service [the states] provided their residents, Washington has picked up two.”
The states have been all too happy to take a program originally designed only to offer bare-bones medical coverage to America’s neediest and transform it into Cadillac coverage for huge numbers of the near-poor and middle class.
Example: Vermont. Under Howard Dean’s watch families with up to $51,000 in income were allowed to quality for Medicaid benefits, and roughly 1 in 5 Vermonters are now on the Medicaid rolls. But Vermont is far from the only state that acts as if it is playing with house money when it comes to Medicaid benefits.
As a solution Gratzer touts Governor Jeb Bush’s plan to give all Medicaid recipients a need-based voucher to buy health insurance. Any money left over could go into a flexible spending account for out-of-pocket health expenses. Under Jeb’s plan Florida’s role would be to “ensure transparency of the private plans and counsel Medicaid recipients about their choices.”
Science Needs A Profit Motive
Steven Pearlstein, Washington Post, 2-4-05
Pearlstein says that “most systems work best when lubricated with a bit of moral ambiguity”—which is another way of saying that you should never let the perfect become the enemy of the good.
He believes that the “bright line” drawn by the NIH against its scientists taking a stake in commercial enterprises will hinder the development of life-saving new medicines and medical devices.
Pearlstein asks: “What great public purpose is served by preventing them from making a buck by sharing [their informal knowledge] with profit-making companies?” Just a few years ago the major complaint against the NIH was that it was an “ivory tower” institution that didn’t produce medical products that people really needed.
Now it appears headed for another bout of self-imposed isolation.
Do abuses happen? Sure, but rather than dealing harshly with individuals who willfully ignored ethics regulations the agency has “caved to pressure from Capitol Hill to prohibit drug and biotech-related investments and commercial entanglements by their researchers.” Building a Chinese wall between industry and the NIH is like keeping the FBI from talking to the CIA. They may have different missions, but neither one of them will do its job as effectively if they can’t share valuable insights and intelligence.
Pearlstein concludes that “having a fuzzy line, and giving administrators some flexibility in enforcing it” was better for all involved. Undoubtedly, the NIH will come to agree with him.
Galen Institute, 2-4-05
Galen takes issue with a new article in Health Affairs alleging that “half of all bankruptcies in the United States are caused by medical problems, especially inadequate insurance coverage.”
Galen criticizes the article for withholding enrollment information about the study population, and poor scholarship generally. Galen notes that the “greatest flaw in the study is the way it defines ‘Major Medical Bankruptcy.’ The authors define it as meaning anyone who declared bankruptcy and had at least $1,000 in ‘medical debts,’ OR were off the job for two weeks due to an illness. These conditions didn’t have to cause the bankruptcy or even contribute to it. The could be merely incidental to someone declaring bankruptcy.”
Suicide Rates Have Decreased With Increased Use of SSRIs, New-Generation Non-SSRIs
Medscape , 2-7-05
A recent article in the Archives of General Psychiatry found that although “antidepressant medication prescription was not significantly related to suicide rate,” prescriptions for SSRIs and other newer antidepressants “were associated with lower suicide rates, both within and among counties.”
The study collected data from all US suicides from 1996 to 1998, and calculated county level suicide rates divided by age, sex, income and race, along with antidepressant use “expressed as the number of pills prescribed.”
The study’s main outcome “was the suicide rate in each county expressed as the number of suicides for a given population size.”
While noting that their aggregate data doesn’t establish a causal relationship between newer antidepressants and lower suicide rates, it may be “a marker for those counties with more limited access to quality mental health care and inadequate treatment and detection of depression, which in turn can lead to increased suicide rates.”
The Cost of U.S. Pharmaceutical Price Reduction
Thomas A. Abbott, John Vernon, NBER Working Paper Program No. 11114, 2-1-05
The authors find that pharmaceutical price controls “will significantly diminish the incentives to undertake early stage R&D investment.” They estimate that “cutting prices 40 to 50 percent in the U.S.” will lead firms to have “30 to 60 percent fewer R&D projects” in early-stage development.
Estimating the Impact of Medical Innovation
Mark Duggan, William N. Evans, NBER Working Paper No. 11109, 2-1-05
A decade ago (1995), AIDS was the eighth-leading cause of death among men, and the single greatest killer of men ages 25-44.
Three years later, the number of AIDS deaths plunged by nearly 70 percent. The authors use data from 1993-2003 to create “a sample of more than 10,000 Medicaid recipients from the state of California” diagnosed with HIV to gauge the impact of new antiretroviral treatments (ARVs) on declining AIDS mortality.
Their conclusions “demonstrate that the increase in the use of the four [ARV] drugs approved by the FDA in late 1995 and early 1996 was responsible for more than 90 percent of the drop in the mortality rate from 1995 to 1998.”
They conclude that although the new drugs tripled lifetime Medicaid spending for these patients, “the new treatments were cost effective, with the average additional cost in Medicaid spending per life-year saved equal to $23,000.”
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