AEI.Org: Scholar: Scott Gottlieb

Changing the Doctor Payment Scheme

Tue, 03 Nov 2009 00:00:00 +0100

The Obama health reform plan, embodied most clearly in a bill now before the Senate, rests on a fiscal deception when it comes to the way Medicare pays America's doctors.

First, a Step Back

Thu, 29 Oct 2009 00:00:00 +0100

It is increasingly clear that the initial impact of President Obama's health care reform will be to raise the cost of health insurance and the number of uninsured Americans, perhaps sharply.

Why You Can't Get the Swine Flu Vaccine

Wed, 28 Oct 2009 00:00:00 +0100

U.S. regulations are too cautious. Europe has adopted a more sensible approach.

Baucus Bill Yeas and Nays

Sun, 11 Oct 2009 00:00:00 +0100

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.

How the U.S. Government Rations Health Care

Thu, 01 Oct 2009 00:00:00 +0100

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.

Obama and the Practice of Medicine

Sat, 15 Aug 2009 00:00:00 +0100

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.

Dissecting the Problem with "Death Panels"

Sat, 15 Aug 2009 00:00:00 +0100

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.

Behind the "Bash Insurers" Strategy

Wed, 12 Aug 2009 00:00:00 +0100

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.

The Elmendorf in the Room

Sat, 18 Jul 2009 00:00:00 +0100

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.

Helping Science, Making Money

Fri, 10 Jul 2009 00:00:00 +0100

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.

Government Health Plans Always Ration Care

Thu, 25 Jun 2009 00:00:00 +0100

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.

Fiscal Instability Is the Administration's Real Political Nemesis, Not the Republicans

Wed, 17 Jun 2009 00:00:00 +0100

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.

An Empty Hand

Tue, 09 Jun 2009 00:00:00 +0100

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.

How ObamaCare Will Affect Your Doctor

Tue, 12 May 2009 00:00:00 +0100

Expect longer waits for appointments as physicians get pinched on reimbursements.

How to Make Better Vaccines--Quickly

Thu, 30 Apr 2009 00:00:00 +0100

If the swine flu virus should continue to spread, or the infections worsen, rapid development of a vaccine could be our best protection.

Would the Health Reform Prescriptions Offered by President Obama and Congressional Leaders ...

Wed, 01 Apr 2009 00:00:00 +0100

Several elements of the health reform plans moving proposed by the White House and moving through Congress would be detrimental to patients.

Stem Cells and the Truth about Medical Innovation

Fri, 13 Mar 2009 00:00:00 +0100

The political rhetoric surrounding embryonic stem-cell science reveals a widespread misconception of how medical products are created.

FDA Must Shift Priorities

Tue, 10 Feb 2009 00:00:00 +0100

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.

Relationships with the Drug Industry: Build Trust Based on Good Science

Wed, 04 Feb 2009 00:00:00 +0100

Consumers and doctors need to work more closely with pharmaceutical product developers.

Congress Wants to Restrict Drug Access

Tue, 20 Jan 2009 00:00:00 +0100

A bill in the House could tie your doctor's hands.

What Medicaid Tells Us about Government Health Care

Thu, 08 Jan 2009 00:00:00 +0100

Why would Barack Obama want to build on a system with poor outcomes?

Obama's Unhealthy Medical Plan

Wed, 29 Oct 2008 00:00:00 +0100

Barack Obama's health care plan is likely to control spending by "managing" it, and in some cases rationing drugs, procedures, and medical devices.

How Obama Would Stifle Drug Innovation

Sat, 18 Oct 2008 00:00:00 +0100

If you want cutting-edge health care, don't make it a cost-controlled commodity.

Michelle Obama Is Right about Avoiding the ER

Tue, 02 Sep 2008 00:00:00 +0100

Barack Obama's health policies hamstring community clinics.

Herbal Legends

Tue, 19 Aug 2008 00:00:00 +0100

Trick or Treatment by Simon Singh and Edzard Ernst, M.D., exposes some of the dangers of alternative medicine.

Pharmaceutical Promotion and First Amendment Rights

Thu, 31 Jul 2008 00:00:00 +0100

Appropriate off-label use of drugs that informs proper patient care is fostered by more communication of truthful information.

Biosimilars: Policy, Clinical, and Regulatory Considerations

Tue, 15 Jul 2008 00:00:00 +0100

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.

Washington's Health Wars: You Lose

Thu, 10 Jul 2008 00:00:00 +0100

The pitting of insurers against health care providers for pieces of the Medicare pie is now an annual Washington event.

What's at Stake in the Medicare Showdown

Tue, 24 Jun 2008 00:00:00 +0100

Shibboleths about government health care's "efficiency" are nonsense.

Genetically Engineered Animals and Public Health

Thu, 19 Jun 2008 00:00:00 +0100

Genetically engineered animals embody an innovative technology that is transforming public health through biomedical, food, and environmental applications.

Measuring Biomedical Progress

Tue, 10 Jun 2008 00:00:00 +0100

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.

Measles Madness

Thu, 08 May 2008 00:00:00 +0100

Creating a "philosophical" exemption for mandatory vaccination stokes deadly outbreaks of diseases long since thought to be eradicated.

Obama's Health Care Record

Mon, 05 May 2008 00:00:00 +0100

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.

From FDA, a Good Framework for Distributing Information on Off-Label Uses

Wed, 23 Apr 2008 00:00:00 +0100

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.

Obama's Health Plan

Tue, 04 Mar 2008 00:00:00 +0100

Critical discusses the Democrat's plan to overhaul the American health care system and provides more detail than the candidates have released.

Cops and Doctors

Wed, 27 Feb 2008 00:00:00 +0100

The strategies being used by the Drug Enforcement Administration to tackle themisuse ofprescription drugsare ineffective andare preventing the development of new medicines.

Edwards and Organ Transplants

Fri, 11 Jan 2008 00:00:00 +0100

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.

Stop the War on Drugs

Mon, 17 Dec 2007 00:00:00 +0100

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.

Stop the War on Drugs

Mon, 17 Dec 2007 00:00:00 +0100

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.

Attack of the Superbugs

Tue, 30 Oct 2007 01:00:00 +0100

The only way to stay ahead of bacterial evolution is to escalate the arms race.

Attack of the Superbugs

Tue, 30 Oct 2007 01:00:00 +0100

The only way to stay ahead of bacterial evolution is to escalate the arms race.

The Sweet Lowdown about Weight Gain

Sat, 06 Oct 2007 00:00:00 +0100

When "low fat" diets became the public health rage in the 1960s, it contradicted centuries of caution about too many carbohydrates.

Trial-Lawyer Kowtow

Thu, 20 Sep 2007 00:00:00 +0100

So the Democrats' drug-safety concerns were about enriching the plaintiffs' bar?

Trial-Lawyer Kowtow

Thu, 20 Sep 2007 00:00:00 +0100

So the Democrats' drug-safety concerns were about enriching the plaintiffs' bar?

The War on (Expensive) Drugs

Thu, 30 Aug 2007 00:00:00 +0100

Your taxes fund flawed science to push cheap medicine.

The War on (Expensive) Drugs

Thu, 30 Aug 2007 00:00:00 +0100

Your taxes fund flawed science to push cheap medicine.

The Falling Sickness Story: Healthiest Justice?

Fri, 03 Aug 2007 00:00:00 +0100

What is behind all the confusion concerning Chief Justice John Roberts's recent seizure?

Uncle Sam, M.D.

Mon, 18 Jun 2007 00:00:00 +0100

Congress seems increasingly intent on usurping the judgment of doctors. This will hit the poor especially hard.

Journalistic Malpractice

Tue, 29 May 2007 00:00:00 +0100

When medical journal editors pursue a political agenda,public healthpaysthe price.

How Safe Is Our Food? FDA Could Do Better

Mon, 21 May 2007 00:00:00 +0100

The Food and Drug Administration is woefully underequipped to deal with U.S. food imports.

Drug Safety Proposals and the Intrusion of Federal Regulation into Patient Freedom and ...

Tue, 01 May 2007 00:00:00 +0100

The expansion of risk-management tools is an imprecise solution to the wrong problem.

Drug Danger

Tue, 17 Apr 2007 00:00:00 +0100

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.

Biologics Legislation Will Speed Progress

Mon, 16 Apr 2007 00:00:00 +0100

Legislation to expose today's biologics to easier competition, after legitimate patents have expired, is going to accelerate development of improved products.

Pitfalls of Private Health Insurance

Wed, 04 Apr 2007 00:00:00 +0100

A new book makes the case for more government-run health care.

Breast Cancer Breakthroughs

Mon, 26 Mar 2007 01:00:00 +0100

The United States has the best cancer-survival rates in the world. Why would we import policies that would undo our progress?

Generic Drug Makers Can Afford FDA User Fees

Tue, 20 Mar 2007 01:00:00 +0100

Nobody has asked what financial and scientific burdens new legislation will place on the Food and Drug Administration.

Medicine & Markets

Mon, 12 Mar 2007 01:00:00 +0100

The Democrats have chosen to pursue "ideologically correct" prescription-drug policies rather than free-market solutions which actually work.

Prescription for Trouble

Tue, 06 Mar 2007 00:00:00 +0100

The increasing regulatory burdens on pharmaceutical researchers threaten to hamper medicinal innovation.

Lean New Pharma

Tue, 13 Feb 2007 00:00:00 +0100

As the costs of drug development increase and the selling prices for drugs decrease, some companies are cutting back.

Opening Pandora's Pillbox

Tue, 12 Jul 2005 00:00:00 +0100

How the Food and Drug Administration responds to criticism of its drug safety process will determine whether drug safety actually improves.

FDA Disappoints Lung Transplant Patients

Wed, 08 Jun 2005 00:00:00 +0100

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?

The Great Drug Shift

Mon, 06 Jun 2005 00:00:00 +0100

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.

FDA's Caution Hurting Patients

Mon, 30 May 2005 00:00:00 +0100

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.

Cancer Patients Are Paying for the FDA's Caution

Fri, 27 May 2005 00:00:00 +0100

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.

FDA Goes Straight to Press

Wed, 11 May 2005 00:00:00 +0100

A steady stream of dire announcements will eventually fatigue the public for important warnings and devalue the voice through which the agency speaks.

Biologics Warfare

Thu, 05 May 2005 00:00:00 +0100

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.

Banks: The New HMOs

Fri, 01 Apr 2005 00:00:00 +0100

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.

Putting Profits ahead of Patients

Tue, 15 Mar 2005 00:00:00 +0100

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.

Let the Market Find a Cure for AIDS

Tue, 01 Mar 2005 00:00:00 +0100

If present policies continue around the globe,HIV drug development in the world of big pharma may be gone for good.

Prostate Drug Promise versus FDA Rigidity

Fri, 18 Feb 2005 00:00:00 +0100

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.

FDA Drug Officers

Thu, 03 Feb 2005 00:00:00 +0100

Information technology can revolutionize drug safety monitoring.

The Burden of Staying Alive

Fri, 21 Jan 2005 00:00:00 +0100

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.

FDA Moves Cancer Cures into the Slow Lane

Tue, 18 Jan 2005 00:00:00 +0100

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.

Assaulting Drug Patents

Sat, 01 Jan 2005 00:00:00 +0100

Satisfying the needs of politicians inside the World Health Organization is not going to fight AIDS infection.

The Price of Too Much Caution

Wed, 22 Dec 2004 00:00:00 +0100

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.

A Legion of Little Helpers

Fri, 10 Dec 2004 00:00:00 +0100

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.

Patient Data Could Lead to Scientific Insights

Fri, 03 Dec 2004 00:00:00 +0100

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.

Pharma's Dilemma Is Biotech's Opportunity

Tue, 23 Nov 2004 00:00:00 +0100

Despite all of the regulatory baggage being heaped on the large drug makers in Washington, their biggest drags may be inside their own laboratories.

Pandora's Pill Box

Fri, 12 Nov 2004 00:00:00 +0100

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.

California's Stem Cell Follies

Mon, 01 Nov 2004 00:00:00 +0100

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.

Kerry Win

Mon, 25 Oct 2004 00:00:00 +0100

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.

Kerry's Medicine

Wed, 20 Oct 2004 00:00:00 +0100

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.

The Price for Being Fussy

Fri, 15 Oct 2004 00:00:00 +0100

The British company producing the flu vaccines was not trying hard enough to keep its factory proficient and pristine.

Vaccine Makers Get a Shot in the Arm

Tue, 12 Oct 2004 00:00:00 +0100

America is currently dependent on a single plant located in England for some of its most important vaccines.

Merck's Pain Is Medicine's Gain

Mon, 04 Oct 2004 00:00:00 +0100

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 Medical Technology

Thu, 01 May 2003 00:00:00 +0100

The future of medicine lies in DNA chips, supercomputers, and new drugs, not embryo research, tissue transplants, or stem cells.

Biosensors Are Not Bioshields

Thu, 27 Feb 2003 00:00:00 +0100

The president's ability to rapidly deploy a series of bioweapons sensors provides evidence why the development of appropriate antidotes could take much longer.

More Drugs Will Mean More Lawsuits

Wed, 26 Feb 2003 00:00:00 +0100

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.

Trinity for Biologists

Mon, 16 Dec 2002 00:00:00 +0100

Scott Gottlieb reviews The Demon in the Freezer: A True Story, by Richard Preston.

U.S. Faltering on Smallpox Protection

Mon, 09 Dec 2002 00:00:00 +0100

The recent revelations that Soviet-era scientists might have passed on a genetically modified strain of the smallpox virus to Iraq probably surprised everyone.

Numbers Game Is Bad Medicine

Sun, 24 Nov 2002 00:00:00 +0100

When surgeons display different propensities to use certain procedures, it's rarely a symptom of malfeasance.

A Sorry Epitaph from the FDA

Tue, 05 Nov 2002 00:00:00 +0100

The FDA tags certain diseases as morally superior to others.

Biotech versus Bioterror

Mon, 28 Oct 2002 00:00:00 +0100

The best new drugs come out of entrepreneurial companies looking for profits.

Up the (FDA) Revolution!

Fri, 04 Oct 2002 00:00:00 +0100

The decision of an FDA advisory panel to recommend accelerated approval of the cancer drug Iressa was indeed a revolt of the doctors.

Bioterror

Wed, 02 Oct 2002 00:00:00 +0100

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?

Sniffing Out Terrorists

Mon, 30 Sep 2002 00:00:00 +0100

Acoming generation of biosensor technology promises to provide more accurate monitoring, and perhaps even obviate the need for human inspection of suspected terrorist spots.

The Mount Sinai Calamity--a Patient Dead and a Hospital in the Red

Thu, 19 Sep 2002 00:00:00 +0100

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.

Smokers Are Pissed at Bloomberg

Thu, 15 Aug 2002 00:00:00 +0100

When government officials impose their own values on the people who elect them, it tears at the fabric of the law.

Fads and Big Fat

Fri, 02 Aug 2002 00:00:00 +0100

Diets remain a largely anecdotal science, working for a few people but not for many, and there is no shortage of fads.

What Genes Can Tell Us

Wed, 24 Jul 2002 00:00:00 +0100

Review of Mapping Human History, by Steve Olson.

Mergers Won't Cure Diseases

Wed, 17 Jul 2002 00:00:00 +0100

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.

The Patients' Side of the Story

Sun, 14 Jul 2002 00:00:00 +0100

Unbridled optimism pervades every level of medical care for AIDS.

Open the DNA Doors

Mon, 01 Jul 2002 00:00:00 +0100

While some Celera executives are chagrined that their former boss bypassed elaborate privacy safeguards, the company’s lawyers should be relieved.

Do No Harm

Mon, 17 Jun 2002 00:00:00 +0100

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.

No News Is Bad News

Mon, 06 May 2002 00:00:00 +0100

Every day, information is routinely withheld from thousands of patients participating in clinical trials.

Our Posthuman Future

Wed, 01 May 2002 00:00:00 +0100

Review of Our Posthuman Future: Consequences of the Biotechnology Revolution,by Francis Fukuyama.

Devices Prolong Life--but at a Big Expense

Thu, 04 Apr 2002 00:00:00 +0100

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?

Prevention is Not a Cure

Fri, 01 Mar 2002 00:00:00 +0100

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.

Uncle Sam, M.D.

Wed, 15 Apr 2009 00:00:00 +0100

This collection of essays provides an indication of the range and depth of AEI’s work in health care reform and pharmaceutical policy.

September 15 Health Care Conference Call

Tue, 15 Sep 2009 13:30:00 +0100

Conference Call: Health Care Reform

Wed, 22 Jul 2009 10:30:00 +0100

Patient-Centered Care versus Political Medicine

Fri, 26 Jun 2009 12:00:00 +0100

The Five (Not So) Easy Pieces of Health Reform

Thu, 04 Jun 2009 09:00:00 +0100

Medicare under Pressure: The 2009 Medicare Trustees' Report

Wed, 13 May 2009 09:15:00 +0100

U.S. Markets for Vaccines: Characteristics, Case Studies, and Controversies

Fri, 08 May 2009 10:00:00 +0100

Pharmaceutical Price Regulation: Public Perceptions, Economic Realities, and Empirical ...

Tue, 17 Feb 2009 09:00:00 +0100

Off-Label Uses of Approved Drugs: Medicine, Law, and Policy

Wed, 21 May 2008 09:45:00 +0100

Oncology Drug Development: Rethinking FDA Oversight

Thu, 13 Mar 2008 11:00:00 +0100

Oncology Drug Development: Rethinking FDA Oversight

Thu, 13 Mar 2008 10:30:00 +0100

What Should Congress Do about Generic or Follow-On Biologic Drugs?

Mon, 11 Jun 2007 13:00:00 +0100

The Perils of Re-importation

Fri, 15 Apr 2005 13:00:00 +0100

Shortening Drug Approval Times via Industry Funding of the FDA

Wed, 16 Feb 2005 10:00:00 +0100

Follow-on Drug Development

Wed, 15 Dec 2004 09:15:00 +0100

The Real Obstacles to Treating AIDS, Malaria, and Tuberculosis in Developing Countries

Wed, 12 May 2004 09:00:00 +0100

Politics, Policy, and Progress in Health Care

Wed, 11 Dec 2002 12:00:00 +0100

The Cost of Being Sick

Tue, 10 Nov 2009 00:00:00 +0100

We must make a concerted effort today to increase our capacity for timely development of safe, effective and innovative flu vaccines.

Hearing on Comprehensive Health Reform

Wed, 24 Jun 2009 00:00:00 +0100

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.

Statement Before the United States Senate Committee on Health, Education, Labor and Pensions

Thu, 11 Jun 2009 00:00:00 +0100

The same health care system capable of delivering innovative, intensive services sometimes fails to provide for the most routine care.

Pharmaceutical Communication to Consumers

Thu, 25 Sep 2008 00:00:00 +0100

Many of the current restrictions on information provided to consumers by pharmaceutical companies do notserve our public health goals very well.

Access to Information in the People's Republic of China

Tue, 31 Jul 2007 00:00:00 +0100

Do controls on information about the safety of Chinese food and drugimports hinder the ability of U.S. regulators to protect American consumers?

Access to Information in the People's Republic of China

Tue, 31 Jul 2007 00:00:00 +0100

Do controls on information about the safety of Chinese food and drugimports hinder the ability of U.S. regulators to protect American consumers?

Safety of Chinese Imports

Wed, 18 Jul 2007 00:00:00 +0100

Testimony on steps the U.S. government is taking and should take to ensure that imports from China are safe for American consumers.

Achieving Drug Access and Affordability without Trading on Future Innovation

Mon, 13 Jun 2005 00:00:00 +0100

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?

Increasing Generic Drug Utilization

Wed, 18 May 2005 00:00:00 +0100

We should increase the availability of safe and effective generic drugs and provide a framework for people to make wider use of them.

FDA's Drug Approval Process

Tue, 01 Mar 2005 00:00:00 +0100

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.

Improving Access to Life-Saving Medicines through Modernization of the Regulatory Review ...

Tue, 27 Feb 2007 00:00:00 +0100

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.

Political Roulette and the Public Health

Thu, 21 Jul 2005 00:00:00 +0100

Considers the impact of political intrusions on drug development and the consequence for America's biodefense.

When Population-Wide Politics and Personal Medical Care Collide

Fri, 13 May 2005 00:00:00 +0100

Public health officials may cause harm in their attempt to promote breastfeeding.

The Living Truth about "Death Panels"

Wed, 07 Oct 2009 00:00:00 +0100

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.

Comparative Effectiveness Research: The Need for a Uniform Standard

Tue, 09 Jun 2009 00:00:00 +0100

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.

Vaccine Readiness in a Time of Pandemic

Fri, 08 May 2009 00:00:00 +0100

We have made progress in pandemic preparedness, but we have a long way to go in ensuring a vibrant and responsive vaccine sector.

Promoting and Using Comparative Research

Mon, 02 Feb 2009 00:00:00 +0100

"Comparative effectiveness research," which, if widely adopted, could lead to much stricter government rationing of health care, is not being widely discussed.

Putting Markets to Work in Vaccine Manufacturing

Mon, 01 Nov 2004 00:00:00 +0100

Legislators should adopt policies that encourage companies to make vaccines more quickly and less expensively.

How Obama Would Stifle Drug Innovation

Mon, 03 Nov 2008 00:00:00 +0100

Senator Barack Obama's drug price and access control proposals will distort future investment decisions and smother the financial incentives that inspire innovation.

A Good Framework for Distributing Information on Off-Label Uses

Thu, 08 May 2008 00:00:00 +0100

The exchange of off-label information and the sharing of scientific evidence can sometimes have important public health benefits.

Edwards and Organ Transplants

Wed, 26 Mar 2008 01:00:00 +0100

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.

Stop the War on Drugs

Fri, 04 Jan 2008 00:00:00 +0100

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.

Drug Danger

Mon, 07 May 2007 00:00:00 +0100

Patients would benefit greatly if the Food and Drug Administration let doctors make decisions for patients based on individual needs.

Breast Cancer Breakthroughs

Wed, 25 Apr 2007 00:00:00 +0100

Could regulations restricting the use of certain drugs curb U.S. cancer survival rates?

Small Leaps or Giant Steps

Wed, 13 Jul 2005 00:00:00 +0100

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.

The Great Shift to Specialty Drugs

Wed, 22 Jun 2005 00:00:00 +0100

Economics and regulatory policy are driving pharmaceutical manufacturers away from the market for treating ordinary medical conditions toward drugs for major health problems.

More Drug Use Will Mean More Lawsuits

Sat, 01 Mar 2003 00:00:00 +0100

Drugs can have unforeseen problems when administered to large and old populations, and the ensuing lawsuits may limit drug development and increase drug prices.

FDA Rules Hinder Cancer Vaccines

Sun, 01 Dec 2002 00:00:00 +0100

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.

Patent Mistakes

Fri, 01 Nov 2002 00:00:00 +0100

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.