In the Spotlight
Bangkok Bust - failing AIDS policy, againThe prostitutes in Bangkok are back at work - no doubt relieved that since the AIDS gravy train left town last week they are no longer receiving daily sermons about condom use. But while the oldest profession was the chief local talking point, the main discussion at the recently completed XV International AIDS Society's conference was of the failing policies of the United States. In addition to the usual stream of complaints that the Iraqi war has diverted attention away from HIV/AIDS, the chief concerns were that US policy was driven by drug company desires to protect patents and that the Bush administration was being stingy.
Roger Bate, 7-29-04
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IRS issues final rules for HSAs
Galen Institute, 7-27-04
The IRS has issued its last rules for Health Savings Accounts for 2004. Now, there are few topics guaranteed to glaze eyes as quickly as arcane discussions of tax policy. Nonetheless, HSAs are so important that this bulletin from the Galen Institute is worth reading over a good cup of coffee. For instance, according to the latest IRS interpretation, individuals with family coverage can make annual contributions to the plan of up to $5,150, or the umbrella deductible, or the embedded deductible multiplied by the number of individuals covered by the plan. Translation: the IRS is allowing a higher annual contribution limit for family HSAs than would’ve been expected based on previous rulings. This is good news when it comes to making HSAs more family friendly. Kudos to the Galen Institute for helping readers decipher the jargon.
Postmarketing Studies Becoming Essential to New Drug Development in the U.S.
Tufts Center for the Study of Drug Development, 7-26-04
Over the last five years (1998-2003), the FDA has requested postmarketing commitments for 73 percent of new drugs released in the U.S. Postmarketing studies, usually to study additional safety and efficacy issues, may help decrease the time required to move new medications from lab bench to market, decreasing the financial risks facing manufacturers and speeding the introduction of new treatment options for patients. "Given widely shared concerns about the cost and time needed to develop drugs, and increased attention focused on the safety of newly marketed medicines, PMCs may help streamline premarket approval of drugs while aiding postmarket identification of adverse drug events and other issues related to drug production and use."
Bioshield Too Little For Drug Industry; Companies Want More Protection From Financial Loss
Washington Post, 7-26-04
The Bioshield legislation signed into law last week by the President was a good first step in government's campaign to protect the nation against bioterrorism. But observers have already weighed in on the shortcomings of the bill and are calling for further legislation. Perhaps the most serious defect in the legislation was its lack of liability protection for industry in the event that vaccines or other treatments have unforeseen side effects or aren't fully effective. After all, widespread testing to discover side effects is virtually impossible - short of an actual attack. One drug industry executive frankly remarked that "until the liability question is solved, we're not going to see big drug companies come to the table." Senators Lieberman, Hatch, and Kennedy have already begun writing new legislation (dubbed "Bioshield II") to address this and other loopholes in the law.
In a Shift, Bush Moves to Block Medical Suits
The New York Times, 7-25-04
Asking local juries to conscientiously sift through mountains of complex scientific evidence (that has already been reviewed by experts at the FDA) in the emotionally fraught confines of a court room is asking the tort system to bear a responsibility it is not designed for.
The FDA already has an extensive mechanism for reviewing the safety and efficacy of drugs, and can review evidence from industry, consumer groups, physicians, and policymakers both before and after a drug has been approved for marketing. The FDA's stance on federal pre-emption of tort claims underscores the reality that a single devastating judgment against a drug or device manufacturer could remove an otherwise life-saving device from the market and weaken the broader financial incentives driving medical innovation. For more on this important issue see Robert Goldberg's The Sacking of Troy
and Robert Pollack’s Dems Win Round One in Hinchey V. Troy
Private screening; Health kits make themselves at home, testing for everything from high cholesterol to colon cancer
Chicago Tribune, 7-25-04
When, last week, the government issued recommendations that patients at high or moderate risk of heart attack lower their LDL or "bad" cholesterol to new, lower levels, people who were already being treated for elevated cholesterol levels undoubtedly took note. But what about Americans who have little time or patience for doctor's visits and have no idea what their cholesterol score is? After all, until you know what your own heart disease risk profile is, you won't take steps to monitor or control your cholesterol levels.
This may change in the near future as an increasing number of relatively inexpensive and sophisticated self-testing kits become available to Americans for ailments ranging from high cholesterol to hepatitis C, HIV, colon cancer, and allergies. While these products are designed to "calm fears and assist doctors", they can also make it easier for physicians and patients to monitor whether or not prescription drugs, once taken, are really as effective as they are purported to be. All-in-all, tests like these put more knowledge in the hands of consumers to better guide their health care decisions.
US drug imports rising despite warnings, FDA says.
Reuters News, 7-24-04
According to government officials, "thousands of packages" containing imported prescription drugs enter the U.S. every year, and it is "impossible for border inspectors to check most of them." A flood of cheaper prescription medications may seem like a boon to U.S. consumers, but safety concerns cannot be breezily waived aside, as many industry critics would like. According to one FDA official, "personal importation can never be made safe and effective." Drug importation, however, will happen if policymakers fail to make the case that market driven innovation and improvement of the drug discovery process are not better alternatives than importing Canadian (or European) price controls.
Drug Industry Set Pace for Armstrong Victory
David Gratzer, Investor's Business Daily, 7-27-04
More Americans are surviving cancer than ever before - thanks to America's commitment to market driven pharmaceutical research. Without that research - and the financial incentives that support it - millions of Americans, including Lance Armstrong, wouldn't be around to appreciate the joys of life.
Studies Show Temporary Drug Program Offers Value to Seniors
Grace-Marie Turner, Galen Institute, 7-26-04
Evidence is mounting that the much maligned temporary drug benefit card program is offering real and substantial benefits to seniors who are enrolled in it. Howard Bedlin, vice president of the National Council on the Aging, went so far as to remark that the drug card program is "a no-brainer for low-income seniors to enroll: They've got nothing to lose since the cards are free and a lot to gain since the subsidies and savings are substantial."
Health Savings Accounts Gain Popularity
Grace-Marie Turner, Galen Institute, 7-26-04
A new study has shown that HSAs are proving popular with groups that critics had alleged would be least able to take advantage of them: families, elderly Americans, and workers at all income levels.
Dems Win Round One in Hinchey v. Troy
Robert L. Pollock, Wall Street Journal, 7-26-04
Democrats have placed a rider on an appropriations bill that strips the FDA's general counsel of funding as a sop to the trial bar - who have a vested interest in undermining the FDA's ability to pre-empt tort claims.
The Sacking of Troy
Robert Goldberg, Ph.D., Washington Times, 7-26-04
The attacks by Congressional Democrats on Daniel Troy, FDA general counsel, are politically and financially driven by the tort bar.
Free health care?
Walter E. Williams, Washington Times, 7-22-04
Economics dictates that in a world of scarcity, nothing is really "free". A look at Canada's "free" health care system shows the real costs it inflicts on patients.
A Shortsighted Path To Cheaper Drugs; Drug Reimportation Will Curtail Research
Rocky Mountain News, 7-21-04
Importing European style price controls on drugs will give us European levels of innovation - hurting patient health and the American economy.
Pause for prescription safety
Washington Times, 7-17-04
Congress shouldn't pass any drug importation bill without adequate safety standards - or that endangers medical innovation.
Navigating the Anticommons for Pharmaceutical Patents
Richard A. Epstein, Bruce N. Kuhlik, John. M. Olin Law and Economics Working Paper, 3-1-04
The current U.S. pharmaceutical patent protection regime strikes the right balance between financial incentives to supply innovative new products and generic drug competition.
The Role of Information in Medical Markets: An Analysis of Publicly Reported Outcomes
David M. Cutler, Robert S. Huckman, Mary Beth Landrum
NBER Working Paper
Imagine, for a moment, that you are an employer considering two different health care insurance plans for your employees. Both firms offer nearly identical services, but one is less expensive than the other. Do you take the less expensive offer? Or do you ask yourself which set of services is better designed to offer quality care for your employees?
Unfortunately, comparative information on health care providers is largely absent, although this study shows why everyone with an interest in lowering health care costs and improving patient health should push harder to make risk-adjusted patient outcomes publicly available. In New York, the Cardiac Surgery Reporting System, which reports patient outcomes across hospitals, has affected both the volume of cardiac cases referred to high quality facilities and provided incentives for lagging performers to improve services.
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