In the Spotlight
Profits and Progress Cannot Be SeparatedThese days the media is full of critics and complainers who, like Marsha Angell, former editor of the New England Journal of Medicine, believe that drug companies deliberately market medicines that add little or no value to the public health. Worse yet, Angell and others accuse pharmaceutical and biotech companies of conducting their research in ways that pervert science and scientist alike. Their criticism amounts to a demand that the entire pharmaceutical industry should either be replaced by a government run drug development agency or neutered through a strong system of compulsory government licenses.
Robert Goldberg, Ph.D., 8-5-04
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Canada feels squeeze from drug makers; Major drug manufacturers have significantly cut back their supplies to Canadian pharmacies, hoping to curtail purchases by Americans in search of cheaper prescription medications.
The Miami Herald, 8-4-04
Canadian pharmacies don't have enough supply to match mounting American demand, partly because pharmaceutical companies have been limiting their Canadian drug shipments to quantities for Canadian use only. Canadian pharmacies have responded by ordering drugs from places further abroad and harder for companies to monitor, for instance Europe and the Fiji Islands.
Current legislation pending in Congress would open U.S. markets to a similarly long list of international suppliers. This creates an interesting question: if the pharmaceutical companies can't monitor all the global shipments of their own drugs now, how does Congress think federal regulators would ever be able to cope?
In Drug Research, Some Guinea Pigs Are Now Human
The New York Times, 8-4-04
The single largest cost in developing new drugs are those compounds that are shown to be either unsafe or ineffective during late-stage testing - i.e., after enormous amounts of money have been spent on them. "Even a small improvement in the ability to predict failures could save $100 million in development costs per drug, the F.D.A. said in a March report." The FDA and industry have responded by exploring how sophisticated new imaging technology (functional MRIs, positron emission tomography, etc.) can test early on whether or not a drug is having the expected effect in the human body. The new emphasis on early testing of drug targets in humans is called "experimental testing" and should enable researchers and companies to target their efforts on drugs that have the best possible chance of success. (For more information on these and related topics see the FDA's report Challenge and Opportunity on the Critical Path to New Medical Products at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
Checking Up on Hospitals: New Web Site Rates Facilities' Performance in Heart, Pregnancy, Pneumonia Care
Washington Post, 8-3-04
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), one of the nation's largest health care accrediting organizations, has launched a website (www.qualitycheck.org) that allows visitors to compare patient care at hospitals state- and nationwide in four areas: heart attack, heart failure, pneumonia, and pregnancy. JCAHO accredits about 16,000 health centers nationwide and hopes to offer visitors more information on non-hospital settings in the future.
This is a valuable step towards building better health care markets - especially in light of a recent RAND study that found that American patients only received recommended care about 55% of the time. Expanding patient and physician access to comparative information on provider outcomes will help to redirect patients - and funding - towards institutions that provide better treatments. (The RAND study findings are available at http://www.rand.org/publications/RB/RB9053/
Off-Label Treatments, New Drugs Target Mysterious, Debilitating Fibromyalgia
Wall Street Journal, 8-3-04
Fibromyalgia is a disorder that causes its victims, mainly women, to suffer from chronic bouts of debilitating pain, sleep disturbances, fatigue, and headaches. Researchers are finally getting a better understanding of the condition, and as a result are turning to drugs approved for other conditions in order to treat the disease. This is known as "off-label use" and involves taking depression, epilepsy, and even cancer drugs and using them in ways that the FDA and the manufacturer had not originally envisioned. Several off-label treatments, including the cancer drug thalidomide, are currently in clinical trials testing their effectiveness in reducing fibromyalgia symptoms. Although off-label use is something of a wild card in the medical community, it is still an important, if serendipitous, tool in the battle against rare diseases like this one.
Lilly Plans Broad Access to Results on Its Drug Trials
Wall Street Journal, 8-3-04
While in many ways the pharmaceutical industry is a victim of its own success (everyone wants access to effective prescription drugs as cheaply as possible) the industry has sustained some well-deserved criticism for its lack of transparency when it comes to industry sponsored clinical drug trials. As long as some trial data remains undisclosed the industry remains vulnerable to the charge that it places drug profits above patient health.
Finally, however, one company is taking its cue from the well-worn political adage that, when it comes to warding off potential scandals, it is always best to tell all that you know as soon as you know it. With that in mind, Eli Lilly has announced a plan to disclose almost all of its clinical trial data from marketed drugs over the last 10 years. Lilly has also promised to embrace data transparency by continuing to reveal data from all "early to late stage clinical trials, including safety information and outcomes." It will even disclose trials that test established drugs for "off-label uses." Dr. Alan Breier, Lilly's chief medical officer, said that "patient care is served best by open disclosure." Dr. Breier is right - and what is good for patient care is also good for the industry.
Combination AIDS Drugs Moving Through FDA's Approval Process
Wall Street Journal, 8-3-04
One criticism repeated ad nauseam by international AIDS activists is that the U.S. isn't serious about approving generic combination AIDS drugs for use in developing countries because it wants to protect the pharmaceutical industry. Nonetheless, the $15 billion President's Emergency Plan for HIV/AIDS Relief has promised that it will purchase the least expensive and most effective medications available - including generics. At the same time, the FDA has adopted a fast-track program for generic AIDS drugs destined for global use, even if the drugs are patented in the U.S. Once a generic manufacturer files an application, the FDA has guaranteed that it will take no more than 4-6 weeks to review it. One leading Indian generic manufacturer, Ranbaxy Laboratories, has already said that it will seek FDA approval for its generic three drug combination before the end of 2004. U.S government agencies have shown their flexibility - and their commitment to helping AIDS patients in the developing world. Perhaps someday the activists will bring themselves to give credit where credit is due.
Biotech Unsure On Kerry
The Boston Globe, 7-31-04
As well they might be. The Kerry campaign has promised to spur medical innovation by supporting federal funding for stem cell research and other high tech cures. At the same time, he has promised to use Medicare's enormous purchasing power to "negotiate" with industry on drug discounts for seniors and to allow all Americans to purchase prescription drugs from countries with price controls, like Canada.
Both proposals would effectively set prices for prescription medications - but without actually calling them price controls. Perhaps Senator Kerry thinks that federal research could easily substitute for private sector biomedical innovation - or perhaps he thinks that price controls won't deter private investment. We look forward to hearing him develop his views on these issues.
Medicare discount cards living up to their hype; A study found that Medicare drug discount cards deliver on promised savings, but confusion is keeping enrollment down.
The Miami Herald, 7-29-04
In the highly partisan debate over the recently enacted Medicare drug discount card program, observers have often been left with the impression that the perfect is, in fact, the blatant enemy of the good. Perhaps the program can be made less confusing. Perhaps the administration needs to find other ways to enroll more seniors. Nonetheless, the two-month old program is proving itself effective when subjected to independent analysis. A study sponsored by the Kaiser Family Foundation has found that the card offers seniors an average discount of nearly 25 percent over retail prices - and even more savings were found when seniors purchased their prescriptions via mail-order. This is good news by any measure - even during an election year.
Patients Get New Guide To Cancer-Treatment Choices: Government 'Map' Aims To Pull Together Latest Data On Trials and Research
Wall Street Journal, 7-27-04
The National Cancer Institute and the Pancreatic Cancer Action Network are launching a free, web-based "map" that will track research, clinical trials, and treatment programs for pancreatic cancer. Although pancreatic cancer is relatively rare (striking just 32,000 Americans annually) it is also deadly - the five-year survival rate for patients after diagnosis is just 4%. Because the disease is often diagnosed in its latter stages every moment counts in finding available treatments. The map could help patients quickly find the best treatments available, and help researchers coordinate their own efforts. If the pancreatic cancer map proves effective, it may serve as a prototype "for tracking research, trials, and key doctors in other cancers, especially rare forms for which information is hard to come by."
Anesthesia, Without a Knockout Punch
The New York Times, 7-27-04
Two decades ago, 1 in 10,000 patients would die from improperly administered anesthesia during surgery; today that risk is only 1 in 250,000. Indeed, the current anesthesia safety record is one of the great unsung victories of modern medical technology. In fact, anesthesia is so safe and effective that almost half of all surgeries are now done on an outpatient basis.
This quantum leap in safety has been accomplished largely thanks to improved technology that allows anesthesiologists to precisely monitor both the amount of carbon dioxide exhaled by patients during surgery (endtidal capnography) and oxygen saturation of the patient's blood (pulse oximetry). New drugs have also helped to alleviate the side-effects of anesthesia (such as nausea) and help regulate a patient's organ systems while sedated.
Often times, medical progress occurs in subtle ways that are unnoticed outside the medical community. This is one success story that should make anyone facing surgery feel a bit better about the process.
Pharmaceuticals and the Worldwide HIV Epidemic: Can a Stakeholder Model Work?
Roger Bate, Joseph Calfee, Ph.D., AEI-Brookings Joint Center for Regulatory Studies, 8-1-04
The global AIDS pandemic has led many activists to call for scrapping the current system of pharmaceutical intellectual property rights and profit-driven innovation. Bates and Calfee argue that shifting the industry to a public interest or "stakeholder" model of drug development would likely undermine essential R&D while doing little to affect the spread of AIDS.
Washington Post, 7-31-04
While states and localities are racing to facilitate prescription drug sales from Canada, the nagging reality is that these sales remain illegal - and potentially unsafe.
Richard Ralston, Washington Times, 7-29-04
The Democrats have now had time to advance their own health care agenda - and a worrisome mix it is.
Entrepreneurs vs. Bioterror
Wall Street Journal, 7-27-04
Passage of the Bioshield Act increases the nation's ability to deter and neutralize potential terrorist attacks.
How Tightly Do Ties Between Doctor and Drug Company Bind?
Abigail Zuger, M.D., The New York Times, 7-27-04
The modern doctor's office is fraught with complexities and conflicting interests. We have to learn how to navigate them effectively.
Trends in U.S. Health Insurance Coverage, 2001-2003
James D. Reschovsky, Bradley C. Strunk
Center for Studying Health System Change Tracking Report No. 9
The Center for Studying Health System change has found that the number of Americans with employer-sponsored health insurance declined 4 points from 2001 to 2003 (from 67 percent to 63 percent). This translates into nearly 9 million Americans who lost their employer sponsored health insurance.
Our health care system is in crisis because the people who use it are isolated from its costs, and therefore have no incentives to economize on treatments and no leverage to demand better patient care. The situation is further aggravated by the fact that both states and the federal government have inundated insurance markets with regulations that make insurance vastly more expensive. As a result, quality is poor and yet costs still spiral out of control.
These problems are endemic to third-party insurance systems, and won't abate until we place more responsibility for health care decisions with individuals, as opposed to employers or the federal government.
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