U.S. regulations are too cautious. Europe has adopted a more sensible approach.
More than anything, the Baucus plan is about exerting control over the delivery of medical care as a way to control cost--and the Centers for Medicare and Medicaid Services will be the instrument of that coercion.
The controversy over aspects of the House health care legislation that have been inappropriately equated with "death panels" has obscured the real problems with these provisions.
President Barack Obama deflects criticism that his health care plan will bring on government rationing of medical care by arguing that insurance companies ration care, but Medicare has been rationing care for years.
Cost consideration must be internalized at the point of care by patients and doctors with a stake in the price, as well as the outcome.
The new health care proposals do not include "death panels," but there are real problems with the end-of-life provisions in the current health care bill.
President Barack Obama and his allies are shifting their health reform rhetoric into an attack on the insurance industry, but their goal remains universal health coverage.
Comments this week by Congressional Budget Office director Douglas Elmendorf reveal a basic if not ultimately fatal flaw of President Obama's current health care plan.
Clinical trials cover a broad range of medical matters, including the testing of new devices, theories and approaches to care. But the most extensive clinical-trial testing is done on new drugs.
If politically safe proposals are implemented and fail to produce savings, government will turn to a less appealing but more familiar tool to cut health care costs: the regulation of access to drugs and medical services.
We owe it to ourselves to make sure decisions to regulate access to medical care are based on sound science and a fair and transparent process.
New spending on health reform could deter foreign investors from buying U.S. treasuries, driving up interest rates and reducing the value of the dollar.
The same health care system capable of delivering innovative, intensive services sometimes fails to provide for the most routine care.
If a new comparative effectiveness research agency is allowed to use different--or inferior--scientific standards than those imposed on the private sector, the government will be the only voice in CER.
President Obama's odds of enacting major health care reform this year are worse than winning at blackjack, despite the fact that it is his game, at his table, and with his dealer.
Expect longer waits for appointments as physicians get pinched on reimbursements.
We have made progress in pandemic preparedness, but we have a long way to go in ensuring a vibrant and responsive vaccine sector.
If the swine flu virus should continue to spread, or the infections worsen, rapid development of a vaccine could be our best protection.
Several elements of the health reform plans moving proposed by the White House and moving through Congress would be detrimental to patients.
The political rhetoric surrounding embryonic stem-cell science reveals a widespread misconception of how medical products are created.
A tainted peanut butter case in Georgia is illustrative of the systemic changes needed so the FDA can focus on what really matters to consumers.
Consumers and doctors need to work more closely with pharmaceutical product developers.
"Comparative effectiveness research," which, if widely adopted, could lead to much stricter government rationing of health care, is not being widely discussed.
A bill in the House could tie your doctor's hands.
Why would Barack Obama want to build on a system with poor outcomes?
AEI Online
November 3, 2008
Senator Barack Obama's drug price and access control proposals will distort future investment decisions and smother the financial incentives that inspire innovation.
Barack Obama's health care plan is likely to control spending by "managing" it, and in some cases rationing drugs, procedures, and medical devices.
If you want cutting-edge health care, don't make it a cost-controlled commodity.
Many of the current restrictions on information provided to consumers by pharmaceutical companies do notserve our public health goals very well.
Barack Obama's health policies hamstring community clinics.
Trick or Treatment by Simon Singh and Edzard Ernst, M.D., exposes some of the dangers of alternative medicine.
Appropriate off-label use of drugs that informs proper patient care is fostered by more communication of truthful information.
The evolution of the European Union’s approach to regulating biosimilars is a potential model upon which we can design a process that facilitates access to biosimilars while providing assurances of safety.
The pitting of insurers against health care providers for pieces of the Medicare pie is now an annual Washington event.
Shibboleths about government health care's "efficiency" are nonsense.
Genetically engineered animals embody an innovative technology that is transforming public health through biomedical, food, and environmental applications.
Chamber of Commerce
June 10, 2008
Many new medical technologies reduce direct health costs, but when they reduce costs in the short run, they often increase costs over the long run.
Creating a "philosophical" exemption for mandatory vaccination stokes deadly outbreaks of diseases long since thought to be eradicated.
The exchange of off-label information and the sharing of scientific evidence can sometimes have important public health benefits.
Barack Obama wants to lower the cost of health care, but his record in Illinois shows that he tends to vote for mandates that raise the cost of insurance.
Rigid adherence to restrictions on the exchange of off-label informationleads to failureto recognize that the sharing of scientific evidence can have important public health benefits.
AEI Online
March 26, 2008
Organ transplantation, like many areas of medicine, provides a poor basis fora political thesis that single-payer health care offers a more equitable allocation of scarce resources.
Critical discusses the Democrat's plan to overhaul the American health care system and provides more detail than the candidates have released.
The strategies being used by the Drug Enforcement Administration to tackle themisuse ofprescription drugsare ineffective andare preventing the development of new medicines.
Contrary to John Edwards's populist rhetoric, the United States performs more organ transplants per capita than countries with single-payer health care systems, with better outcomes.
AEI Online
January 4, 2008
Politicians wage broad wars on medicine to claim thin strips of ideological terrain. This would be good political theater if there weren't so many human victims.
Politicians wage broad wars on medicine to claim thin strips of ideological terrain. This would be good political theater if there weren't so many human victims.
Politicians wage broad wars on medicine to claim thin strips of ideological terrain. This would be good political theater if there weren't so many human victims.
The only way to stay ahead of bacterial evolution is to escalate the arms race.
The only way to stay ahead of bacterial evolution is to escalate the arms race.
When "low fat" diets became the public health rage in the 1960s, it contradicted centuries of caution about too many carbohydrates.
So the Democrats' drug-safety concerns were about enriching the plaintiffs' bar?
So the Democrats' drug-safety concerns were about enriching the plaintiffs' bar?
Your taxes fund flawed science to push cheap medicine.
Your taxes fund flawed science to push cheap medicine.
What is behind all the confusion concerning Chief Justice John Roberts's recent seizure?
Do controls on information about the safety of Chinese food and drugimports hinder the ability of U.S. regulators to protect American consumers?
Do controls on information about the safety of Chinese food and drugimports hinder the ability of U.S. regulators to protect American consumers?
Testimony on steps the U.S. government is taking and should take to ensure that imports from China are safe for American consumers.
Congress seems increasingly intent on usurping the judgment of doctors. This will hit the poor especially hard.
When medical journal editors pursue a political agenda,public healthpaysthe price.
The Food and Drug Administration is woefully underequipped to deal with U.S. food imports.
Patients would benefit greatly if the Food and Drug Administration let doctors make decisions for patients based on individual needs.
The expansion of risk-management tools is an imprecise solution to the wrong problem.
AEI Online
April 25, 2007
Could regulations restricting the use of certain drugs curb U.S. cancer survival rates?
Patients would be better off if the FDA focused on unearthing information to help doctors determine which pills will perform the best for each individual patient.
Legislation to expose today's biologics to easier competition, after legitimate patents have expired, is going to accelerate development of improved products.
A new book makes the case for more government-run health care.
The United States has the best cancer-survival rates in the world. Why would we import policies that would undo our progress?
Nobody has asked what financial and scientific burdens new legislation will place on the Food and Drug Administration.
The Democrats have chosen to pursue "ideologically correct" prescription-drug policies rather than free-market solutions which actually work.
The increasing regulatory burdens on pharmaceutical researchers threaten to hamper medicinal innovation.
For unmet medical needs, FDA also needs to move away from its prevailing orthodoxy that approval is a binary event in the life of a drug.
As the costs of drug development increase and the selling prices for drugs decrease, some companies are cutting back.
Considers the impact of political intrusions on drug development and the consequence for America's biodefense.
New drug treatments often take time to prove their effectiveness, and medical progress will slow if the lack of immediate and dramatic results disqualifies new drugs from research and use.
How the Food and Drug Administration responds to criticism of its drug safety process will determine whether drug safety actually improves.
Economics and regulatory policy are driving pharmaceutical manufacturers away from the market for treating ordinary medical conditions toward drugs for major health problems.
Japanese Diet
June 13, 2005
How do we continue to pay for new drugs and and more innovative treatments, especially when this additional progress also comes with an additional economic cost?
How many lives will recent criticism of the FDA by camera-keen congressmencost when promising new treatments are kept out the hands of patients who otherwise are going to die?
For the shift away from everyday drugs toward longshot, big-payoff remedies, you can thank regulators, insurers' reimbursement schemes, and the madness of tort litigation.
Daily Oklahoman
May 30, 2005
While the FDA is trying to save patients from the harmful effects of new medicines,manymore patients will die waiting for the good medicines than from using bad ones.
Medical Progress Today
May 27, 2005
Under current Food and Drug Administration cancer policies, many more patients will die waiting for the “home-run” drugs than would be harmed by mediocre ones.
We should increase the availability of safe and effective generic drugs and provide a framework for people to make wider use of them.
Independent Women's Forum
May 13, 2005
Public health officials may cause harm in their attempt to promote breastfeeding.
A steady stream of dire announcements will eventually fatigue the public for important warnings and devalue the voice through which the agency speaks.
Drugpolicymaking seems to have left the patient out of the equation, while focusing only onthe political calculus of how angry politicians can take a bite out of the industry's hide.
A transformation is under way in health care that will displace the entrenched giants among the ranks of America's health maintenance organizations and pharmacy benefit managers.
Forbes.com
March 15, 2005
Price regulations are discouraginginnovation,and big drug makers are diverting capital away from research and development and pumping it into the less risky business of generic drugs.
If present policies continue around the globe,HIV drug development in the world of big pharma may be gone for good.
The Food and Drug Administration's mission has become increasingly complex. As the sophistication of its mission increases, so must the tools it uses for accomplishing its work.
We ought to make sure the Food and Drug Administrationis infused with the thinking and the resources to advance alongside the science it's charged with regulating.
Medical Progress Today
February 3, 2005
Information technology can revolutionize drug safety monitoring.
If the Food and Drug Administration's policy stands, cancer patients will have to wait many more years to get access to new drugs, and they will have fewer options in the process.
A fresh crop of caution inside the FDA may keep the agency out of the news, but it won't keep cancer patients from dying.
Global AIDS Link
January 1, 2005
Satisfying the needs of politicians inside the World Health Organization is not going to fight AIDS infection.
New York Sun
December 22, 2004
When it comes to making new drugs safer, most of the obvious solutions are already accounted for; we have reached the flat part of a curve that measures incremental safety against the additional cost.
In a culture where we medicate at every opportunity, the real surprise in the wake of baseball's steroid mess may be not how many players used the drugs to gain an edge, but how few.
Wall Street Journal
December 3, 2004
We should be providing pathways for practical data collected from real patient experiences to be used for drug label changes inside the FDA and quick payment decisions by Medicare.
Despite all of the regulatory baggage being heaped on the large drug makers in Washington, their biggest drags may be inside their own laboratories.
New York Sun
November 12, 2004
Patients claiming they were harmed byMerck's drugare likely to prove that the company tried to sit on hard medical evidence with hopes that it could run out the clock on its drugs' patent.
AEI Online
November 1, 2004
Legislators should adopt policies that encourage companies to make vaccines more quickly and less expensively.
If Proposition 71(a state initiative to fund stem-cell research)passes, cash-strapped California taxpayers will be spending their money on a handful of second-rate biotech companies.
If John Kerry's campaign rhetoric matches his governing style, after the election things could get much worse for the scientists and companies that make medical products.
New York Sun
October 20, 2004
John Kerry's plan for lowering U.S. health care costsincludes the importation of European and Canadian drugs. But Americans may not like what they would get under this arrangement.
Washington Times
October 15, 2004
The British company producing the flu vaccines was not trying hard enough to keep its factory proficient and pristine.
America is currently dependent on a single plant located in England for some of its most important vaccines.
Health care hawks in Congress may seize on painkillerVioxx’s woes to push for major changes in the Food and Drug Administration’s drug approval process.
The future of medicine lies in DNA chips, supercomputers, and new drugs, not embryo research, tissue transplants, or stem cells.
Drugs can have unforeseen problems when administered to large and old populations, and the ensuing lawsuits may limit drug development and increase drug prices.
Washington Times
February 27, 2003
The president's ability to rapidly deploy a series of bioweapons sensors provides evidence why the development of appropriate antidotes could take much longer.
New York Sun
February 26, 2003
Without product liability reform, prescription drug coverage will morph into a full employment act for the lawyers, limiting development of new drugs and driving up prices for everybody.
New York Sun
December 16, 2002
Scott Gottlieb reviews The Demon in the Freezer: A True Story, by Richard Preston.
Washington Times
December 9, 2002
The recent revelations that Soviet-era scientists might have passed on a genetically modified strain of the smallpox virus to Iraq probably surprised everyone.
AEI Online
December 1, 2002
The Food and Drug Administration must use rigorous drug trials, but these tests should not be so strict as to deny cancer patients access to potentially lifesaving drugs.
Los Angeles Times
November 24, 2002
When surgeons display different propensities to use certain procedures, it's rarely a symptom of malfeasance.
New York Sun
November 5, 2002
The FDA tags certain diseases as morally superior to others.
AEI Online
November 1, 2002
Washington must continue to guarantee drugmakers a certain period of exclusivity, increase the transparency of the patent system, and close legal loopholes used by drugmakers and generic competitors.
The Weekly Standard
October 28, 2002
The best new drugs come out of entrepreneurial companies looking for profits.
The Wall Street Journal
October 4, 2002
The decision of an FDA advisory panel to recommend accelerated approval of the cancer drug Iressa was indeed a revolt of the doctors.
USA Today
October 2, 2002
If terrorists exposed your hometown to a deadly virus, which would you want: a vaccine that prevents infection or a drug that effectively treats it after a person has become ill?
Forbes
September 30, 2002
Acoming generation of biosensor technology promises to provide more accurate monitoring, and perhaps even obviate the need for human inspection of suspected terrorist spots.
New York Sun
September 19, 2002
It's because hospitals like Mount Sinai admitted difficult medical cases, deployed expensive technology, and performed difficult operations that they now find themselves deep in the red.
New York Sun
August 15, 2002
When government officials impose their own values on the people who elect them, it tears at the fabric of the law.
Wall Street Journal
August 2, 2002
Diets remain a largely anecdotal science, working for a few people but not for many, and there is no shortage of fads.
The New York Sun
July 24, 2002
Review of Mapping Human History, by Steve Olson.
Wall Street Journal
July 17, 2002
Pfizer has acquired the ability to realize extended cost savings that will gun its earnings over the next several years as the combined shop realizes a whopping $2.5 billion in savings by 2005.
Los Angeles Times
July 14, 2002
Unbridled optimism pervades every level of medical care for AIDS.
The American Spectator
July 1, 2002
While some Celera executives are chagrined that their former boss bypassed elaborate privacy safeguards, the company’s lawyers should be relieved.
Barron's Online
June 17, 2002
Medical datais sealed up at the FDA, in applications and reports that researchers must file before receiving the agency's approval to conduct trials or market new drugs.
American Spectator
May 6, 2002
Every day, information is routinely withheld from thousands of patients participating in clinical trials.
Review of Our Posthuman Future: Consequences of the Biotechnology Revolution,by Francis Fukuyama.
What happens when a new lifesaving medical treatment comes along that is so good, it is difficult to deny to a patient, but so expensive it could bankrupt the entire system if given to everyone who needed it?
The American Spectator
March 1, 2002
Managed care wasn't conceived as a cheaper alternative to the fee-for-service indemnity insurance of the years when insurers cheerfully paid for all the health care doctors prescribed.
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