The Bush Administration has redefined the nation’s public health.  Regulation of food, safety and health, will now occur only in cases of “market failure.”  Yet the examples of Cox-2 anti-inflammatories like vioxx, and the SARS epidemic have demonstrated similar “market” calculations easily fail, with catastrophic consequences.  Changing the rules for further Federal dysregulation may soon produce a similar result: cefquinome, a fourth generation cephalosporin antibiotic, is poised for FDA approval, against the advice of its own health panel and most experts.

Cox-2 inhibitors

         Aspirin was once the only effective anti-inflammatory drug.  Yet it caused many side effects.  Aspirin related gastric bleeding caused thousands of deaths a year.

         The Cox-1 inhibitors, like ibuprofen and naproxen, were devised to avoid these side effects.  They, too, caused considerable gastric bleeding.

         The Cox-2 inhibitors were originally devised to avoid the gastric ulcers and bleeding created by aspirin and Cox-1 inhibitors.  At first they appeared to succeed, and quickly took over the market.  As one rheumatologist told me five years ago, “they’re expensive, and they’re really no better than the old drugs.  But you’ve got to use them. They’ve become the standard of care.”

         Pfizer and Merck, among others, were making billions in profits on vioxx and celebrex each year. The companies quickly attacked reports of Cox-2 induced heart attacks. The drugs were too profitable to give up.

         Looking back, it is clear even in the public literature that well before the Cox-2s were banned they increased cardiac mortality.  When it became obvious the drugs not only increased heart attack risk but that the companies knew and had suppressed such data, the drugs were taken off the market.

         The costs?  Pfizer and Merck each lost half their stock market value. They have sequestered tens of billions to pay court and malpractice claims.  Perhaps a hundred billion dollars vanished.  Thousands lost their jobs. 

         But those are “market costs.”  Thousands died.  Their heart attacks could have been avoided, if the companies had accepted their own research, or if the FDA had done its job.

SARS

         SARS came out of a nowhere.  A standard cold virus mutated into a lethal killer.

         Toronto, a world class health care center, was the only city in the world hit twice by SARS.  The first epidemic was so severe, travel to and from the city was stopped.  Businesses were furious.  

         As hospital cases decreased, the city and provincial government worked to end the WHO travel advisory.  The technique they adopted was similar to recent Bush administration actions – they changed the rules. The Toronto authorities decided to get rid of the travel advisory by changing the definition of a SARS case.  Infectees were counted as potential SARS only if they had documented previous contact with a known SARS case.

         As expected, the disease counts dropped.  Ten days after the WHO declared Toronto SARS free, a new epidemic flared.

         Community infections had spread from persons who were not diagnosed SARS victims. By  government definition they were not “known cases” – they didn’t count.  The public health disaster severely weakened the Toronto economy.

         Such a scary result may soon recur.  A recent study shows that about half of new AIDS cases can be traced to people who are infected but not yet diagnosable, since they  lack antibody markers of the disease.  By narrow medical definition, these carriers are not afflicted with AIDS.  Stuffed with virus, they can walk into a clinic, be told they’re HIV negative, go out and give others AIDS.

Cefquinome

         The FDA is set to approve cefquinome, a fourth generation cephalosporin, for treatment of bovine respirary disease.  The approval will come as a result of a new Bush administration “guidance document,” number 152.  Unless a direct link to human illness or antibiotic resistance can be demonstrated, the antibiotic “must” be approved.

         Bovine respiratory disease occurs in large part due to densely sequestered cattle being transported hundred of miles to slaughter. A dozen drugs already work to destroy bovine respiratory disease.  Fourth generation cephalosporin animal use in Europe has caused increasing antibiotic resistance to many third and fourth generation cephalosprins, drugs that are needed to treat people.    Approving cefquinome may cause many thousands of Americans to be without effective treatment for a host of fatal illnesses, particularly hospital based infections.

Health or Short Term Profit?

         There is a reason the laws establishing EPA and OSHA made the public health, not cost benefit, the centerpiece for regulation. Survival matters.   You have to protect the population first.

         Cox-2 inhibitors nearly wrecked some of the largest, most effective pharmaceutical companies on earth.  Short sighted policy advisors produced a crisis in Toronto that took years to overcome.  Similar disasters are now scripted for this country, as antibiotic resistance to Methicillin resistant staphyloccocus and clostridium difficile kill thousands each year.

         The first criterion of protection should be the health of all citizens.  The US government spent $5 billion protecting against anthrax.  How many died? Five. Many of those targeted by the anthrax scare where politicians.

         The rest of us also need protection. That protection is needed against both “market failure” and government dysregulation.  It’s no fun being rich when you’re dead.  

Dr. Matthew Edlund, M.D., M.O.H., director of The Center for Circadian Medicine, is an expert on applied public health, sleep medicine and psychiatry. A former professor at Brown and University of Texas medical schools, he can be reached via email to DocME@DoctorEdlund.com. And CLICK HERE to subscribe to our new Fitcast, via the iTunes Store.