|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 06-14-2004
Mandatory Testing Bolsters Botswana in Combating AIDS
While African nations are gaining better access to HAART treatments (Highly Active Anti-Retroviral Therapy) and the U.S. is ramping up funding for AIDS medicines in developing nations, this article describes some very simple measures that developing nations are taking now that can significantly help to manage the AIDS epidemic. For instance, a critical shift in government policy: instead of offering HIV tests only to those who asked for them (following the Western model that emphasizes patient confidentiality) the government in Botswana now orders tests for everyone who comes into a hospital or clinic, unless that person objects.
The result of this simple change? The HIV testing rate in Botswana has quadrupled and doctors are catching patients in the early, more treatable stages of infection. This is a critical development because doctors will have a realistic chance to use HAART to stabilize patients while they are still healthy and productive, before they become a severe drain on the nation's medical and social resources. Providing affordable medications to developing nations is an important component of efforts to conrol AIDS and other infectious diseases; but at least as important is pairing the right infrastructure and public policies with the right medicines. When any one of the three is missing, disease containment can be effectively crippled.
Novartis, Pfizer Drugs Found Equal in Cutting Cardiac Deaths
The results of a six year study sponsored by Novartis AG pitting their blood-pressure drug Diovan against Pfizer's Norvasc showed that the drugs are equally effective in preventing cardiac related deaths in high risk patients. Norvasc, whose patent will expire in about three years, is an older type of heart disease medication known as a calcium channel blocker, while Diovan is a newer class of drug, an angiotensins receptor blocker. Norvasc is the biggest selling hypertensive drug in the world, and Novartis was hoping to make gains against Prizer's blockbuster drug.
Nonetheless, Diovan did show a superior ability to reduce the onset of diabetes, an important finding considering the increased mortality and morbidity associated with hypertensive patients who develop diabetes. While some observers will argue that Norvasc (soon to become a generic) was the clear winner in this study, the reality is that physicians and patients will have to carefully weigh the increased risk of diabetes attendant with the use of calcium channel blockers versus the increased cost of newer drugs. In other words, the newer, more expensive drug may still turn out to be the preferred treatment for some - perhaps even many - hypertension patients. While head-to-head studies like these are critical components of providing better patient care, readers would be well advised to resist the suggestion that large studies can dictate one-size fits all treatment plans.
Vaccines Show Promise Fighting Parkinson's, Other Brain Diseases
The war against disease is waged on many fronts simultaneously, often with old weapons - like vaccines - deployed in innovative new ways. A range of new vaccines is currently in development that help prevent the cell atrophy associated with neurological diseases like Parkinson's, Alzheimer's, and Huntingdon's. These vaccines, several of which are approaching Phase 3 drug trials, work by enhancing the body's own immune response and accelerating the healing process. One vaccine, given to mice with Parkinson's disease, provided substantial protection - saving about half of the nerve cells that would otherwise have been destroyed by the disease. While observers will have to await the outcome of larger human trials to establish safety and efficacy, there is hope that these vaccines will give doctors powerful new treatments in the struggle against diseases that rob victims of their independence and ability to lead normal lives. The question is, if these vaccines prove successful, will the government attempt to impose price controls on them that hamstring further vaccine development and deployment - one would hope not, but the government's record with other vaccine programs is poor indeed.
One of the benefits of the Medicare drug card is providing seniors - and the media for that matter - with a real sense of not only what drugs cost, but comparisons between newer, more expensive drugs, and their generic equivalents. For instance, as this article notes, in the class of anti-depressants, the generic drug Prozac (fluoxetine) is a therapeutic alternative to the newer, patented drug Zoloft - and sells for a fraction of the price for a 30 day supply ($4.78) versus Zoloft ($72). However, "drugs are not always interchangeable", as this article notes, because fluoxetine can interfere with many heart medications that are often prescribed for seniors. Zoloft also causes far fewer allergic reactions. So which drug is better? This is a question that can only be answered by a consultation between a doctor and patient, weighing the pros and cons of price versus expected benefits for their particular case. The role of the government - well served in this case - is in making this information widely disseminated so that consumers and health care providers can make the best decisions possible.
Pharmacists Offer Drug-Discount Card as Rival to PBMs'
One of the perennial complaints about American healthcare is there are too many players in the game, with myriad healthcare providers and insurers wrangling over every health care dollar, with the result that patients have very little leverage with which to bargain for the best care or the best prices. There is some evidence that that is beginning to change, and the avalanche of information supplied by the Medicare Modernization Act of 2003 deserves some credit for recent advances.
The drug supply chain is certainly one case in point: between manufacturers and prescription drug users there are numerous middlemen (wholesalers, pharmacy benefit managers, and the pharmacists themselves) who help the products reach market, but also add to the cost of prescription drugs. Now that Medicare recipients can purchase drug benefit cards for as little as $30 a year that give them direct access to the medications they need, many of these middle men have incentives to compete with each other to try to capture market share by offering the lowest prices available.
The struggle over pricing has become particularly sharp between independent pharmacists and PBMs (pharmacy benefit managers), who traditionally manage prescription drug programs for health plans and large employers. PBMs are offering their own discount card, and steering seniors to bulk mail order prescriptions, locking local pharmacists out of the equation altogether.
Independent pharmacists have in turn banded together to offer their own card as a non-profit venture, as well as offering full disclosure on the discounts that they receive from manufacturers - a departure from PBM practice, which are usually more secretive about the discounts they receive. Pharmacists insist that their card, Community CareRX, will provide an average discount of 30% off retail prices.
At the same time, PBM's respond that they are providing an unprecedented amount of information about their drug purchases to the Medicare drug program, which is then made public. Overall, PBM's claim that their prices are lower because they encourage more bulk mail order prescription drug purchases.
In the midst of all sniping between trade associations who really wins? Consumers. For the first time, seniors can track drug prices, hunt for discounts, and challenge providers to match competitors prices.
No matter how powerful a medication is, it will inevitably offer less benefits to some patients than to others. The reality is that every patient metabolizes medications via their own unique genetic pathways, and sometimes the differences are substantial enough to cause crippling side effects - or no effect at all.
Statins, cholesterol-lowering drugs, may be the next aspirin - a versatile, powerful, inexpensive medication that will find new uses for decades to come, and benefit tens of millions of patients. On the other hand, researchers have already discovered that patients with certain genetic markers will get less benefit from statin treatment than others.
As it stands now, doctors prescribe the vast majority of drugs (including statins) without really knowing who stands to gain the most from treatment. Trial and error is, unfortunately, still the best standard of care when it comes to drug treatment. However, a study published recently in the Journal of the American Medical Association could lead to a basic genetic test that would determine what statin drug is best for individual patients. This is the long-heralded promise of personalized medicine - a treatment regime that would fit your unique genetic profile like a glove. The study found that "patients with a certain common genetic variant had a 22% smaller drop in total cholesterol and a 19% smaller drop in LDL or 'bad' cholesterol than those patients without the variant." Drug manufacturers and other researchers are calling for further testing on all drugs in the statin class to determine if other genetic variants impact the effectiveness of the drugs.
The promise of personalized medicine - otherwise known as pharmacogenetics - is still in its infancy, but as it is developed and employed earlier in the drug development process, it will revolutionize not only treatment, but also how we develop and market new medicines.
U.N. Agency Drops 2 Drugs For AIDS Care Worldwide
Pharmaceutical companies who develop patented drugs have long expressed concerns that generic drug manufacturers are not required to meet the same standards for drug purity and bioavailibility as their own medications - which are developed under stringent regulatory oversight, and can only be marketed after onerous testing for safety and efficacy. Some of these concerns may have been vindicated recently when the World Health Organization removed two generic anti-retroviral drugs from its list of approved HIV drugs for use in poor countries, "saying a routine check found the manufacturer had not proved that they were biologically equivalent to patented drugs." Although the drugs manufacturer had procured a laboratory to test bioequivalence, the laboratory did not provide the WHO with sufficient documentation and therefore "did not meet the standards known as good clinical and laboratory practice." The real danger may not come from well-established companies like Cipla, but from dozens of other fly-by-night manufacturers who may enter the lucrative generic AIDS drug market when patent restrictions are widely relaxed. Although activists widely deride patent protections, patents benefit consumers by ensuring that regulators have carefully assessed quality and potency; when patents are waived without careful regulatory oversight, patients can be exposed to snake-oil remedies that cost lives.
GAO Uncovers Flaws In Online Drug Sales
Researchers at the Government Accounting Office (GAO) were able to purchase drugs online without prescriptions according to testimony delivered to the U.S. Senate. Out of the nearly 70 purchases made by the GAO over 6 months (January to June) 45 required no prescriptions at all - "even if the medicines were addictive and or had serious safety restrictions." Other products did not have accurate labeling, were not shipped properly, or arrived without adequate information for patients. The GAO's findings underscore the growing amount of evidence documenting that internet drug importation is a gaping hole in U.S. regulation of prescription drugs, a gap easily exploited by unscrupulous internet firms.
Increasing co-pays could ultimately cost employers
Researchers from the RAND Corporation have found that when employers double out-of-pocket expenses for prescription drugs (co-pays), patients reduce the use of prescription drugs for chronic conditions like diabetes, asthma, and ulcers by 23%.
While some employers have shifted rising insurance costs to employees in the form of higher tiered co-pays for prescription drugs, researchers warn that this tactic could backfire in the case of chronic illnesses that can significantly worsen without drug treatment. As a result, employers and insurers may wind up footing higher bills in the long term as patients are driven towards increased emergency room visits and longer hospital stays.
The researchers found the greatest reductions in patient use of nonsteroidal anti-inflammatories and antihistamines: 45 and 44 percent respectively. Among patients with stomach ulcers, asthma, and diabetes, increased co-pays resulted in increased emergency room visits (17 percent) and hospital stays (10 percent). This is yet another reminder that while prescription drugs are expensive, they are often the equivalent of productivity upgrades for human health. Funding new inventory tracking software for your office may seem ridiculously expensive at first, but it pays for itself by reducing spending elsewhere over time. So too with new medicines that are expensive at first, but keep patients healthier and more productive than any other alternative available.
Last year the U.S. imported about a billion dollars in drugs from Canada, not a trivial sum, but only a fraction of the total U.S. prescription drug market - valued by the Congressional Budget Office at over $160 billion in 2003. Expanding that fraction rapidly would probably lead to an exponential increase in illicit or counterfeit drugs reaching consumers, since regulators would be overwhelmed by the sheer magnitude of the market. Even today, GAO researchers have already uncovered disturbing evidence that "narcotics are bought without a prescription from online U.S. pharmacies." Although there may be stricter internet standards in Canada, that still doesn't eliminate the two central hazards posed by wide scale importation: consumers would be hard pressed to distinguish genuine Canadian internet pharmacies from counterfeit sites, and other countries (subject to even less U.S. oversight) would have to fill the gap between Canadian supply and American demand.
Worse still, no other foreign pharmacies in the GAO's study required prescriptions before filling a patient's order: "Investigators found widespread problems purchasing prescription medicines from many foreign countries. Some drugs were counterfeit; many arrived without instructions or patient warnings." In other words, a credit card can get you easy access to prescription drugs on the internet - including narcotics. Until there is a comprehensive plan in place for addressing these problems, Congress would do well to view drug importation with trepidation and take heed from the Hippocratic oath - first, do no harm.
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