Red Tape Choking Us

  • by: |
  • 10/21/2005

From the pensive pen of Dr. Sally Pipes:

“We are not prepared for a pandemic,” Health and Human Services Secretary Michael Leavitt said earlier this month. We do, however, face a significant risk of being hit by one. A new strain of the avian flu, known as H5N1, has killed at least 60 people in Asia since 2003. So far, humans cannot pass it to one another — virtually everyone infected caught the virus from a diseased bird.

The risk to people is nevertheless grave. The 1918 Spanish flu epidemic, blamed for 50 million deaths, also started among birds, but it mutated and spread to humans. Scientists fear the same thing could happen now. As an expert epidemiologist recently told the Wall Street Journal, “It龝 not a question of if, but when.” The Centers for Disease Control (CDC) estimates that an avian-flu pandemic could kill between 89,000 and 207,000 Americans. There is no publicly available vaccine for the new strain.

Now that the threat is upon us, the administration says it plans to bolster vaccine production in the United States and purchase huge quantities of antiviral drugs. But the question is: Why weren’t we ready in the first place?

The United States once had a large vaccine industry. In 1957, 26 companies supplied the market for standard children’s vaccines — but now only four companies do. Three decades ago, at least 10 U.S. firms manufactured vaccines to treat seasonal flu. By the late 1990s only five remained. And in 2004, the entire U.S. flu-vaccine market depended on just two companies — a French firm with a factory in Pennsylvania, and a California firm with a factory in Great Britain. Hence, our sense of crisis during last year’s flu season, when contamination at the British plant curtailed supply.

The only avian-flu vaccine likely to be available soon is made by the French company Sanofi-Aventis — the same firm we rely on for seasonal flu vaccines. The Sanofi-Aventis vaccine against H5N1 is undergoing preliminary U.S. government testing and showing early signs of success, but it’s not clear how soon it could be available. California-based Chiron — the one with the contaminated British plant — says it will have an H5N1 vaccine ready for testing by the end of the year.

To develop new and better flu vaccines is well within the reach of science. So why don’t U.S. drug companies, which dominate the global medicine market, make vaccines?

First, vaccines are subject to excessively strict screening by the Food and Drug Administration (FDA). So, for example, FluMist, a flu vaccine delivered via nasal spray, has only been approved for use for people aged between five and 49. It is our youngest and oldest, however, who run the greatest risk of catching the flu. This means that the cost of researching and developing new vaccines is needlessly expensive.

Second, vaccines are very expensive to produce. Using one older method of making flu vaccine, it costs about $300 million to build a factory and takes almost five years to get it completed and inspected. The company that makes FluMist, Maryland-based MedImmune Inc., could produce 20 million doses a year, but only about two million would get by the regulators. Because flu vaccine doesn’t keep, in 2003 MedImmune was forced to discard four million doses of its product.

Third, out-of-control lawsuits have scared companies away from developing and producing vaccines. For example, a researcher claimed in the 1970s that the whooping-cough vaccine caused brain damage. More than 800 lawsuits were subsequently filed in the U.S. against vaccine makers. Scientists later proved conclusively that there was no link between the vaccine and brain damage, but by that time the manufacturers were already out of business.

If companies stood a chance of recouping their investments, all these high costs of doing business might be manageable. Government price controls, though, make getting a return next to impossible. The Vaccines for Children Program was the final nail in the coffin of the American vaccine industry. Established by the Clinton administration in 1994, it established a single-buyer system for children’s vaccines. The government now buys 57 percent of all childhood vaccines, forcing steep discounts on manufacturers.

In short, litigation, regulation, and price controls have strangled our ability to prevent deadly diseases, among them avian flu. It doesn’t have to be this way. America leads the world in making medicine. Pharmaceuticals created by U.S. firms have made our lives longer, more comfortable, and more productive in ways our forefathers couldn’t have imagined. People everywhere clamor for AIDS and cancer medications invented in the United States. If we remove the red tape that has choked off vaccine production, we could have a healthy vaccine industry too.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog