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Is the FDA setting us up for the Super Bug?
Perspective on the News
Monday, April 11, 2011
Ed DeShields

In August 2010, a Belgian man was involved in a car accident during a trip to Pakistan. He was hospitalized with a major leg injury and immediately repatriated to Belgium.  He later died; not from his injuries but from something far more sinister.

The man would become posthumously famous as the first reported death due to a bacteria modified by the nasty, drug-resistant gene called the NDM-1 enzyme. NDM-1 causes cholera and dysentery proving the theory that it is not solely a hospital-acquired infection but is present in the environment.   Worse yet, NDM-1 can transform up to a dozen common bacteria species into killer sicknesses that drugs can’t stop.

The man had become infected while being treated in a hospital in Pakistan.  Despite being administered Colistin, a powerful antibiotic, he didn’t have a chance. 

It takes about 10 years, and about $1 billion dollars, to get a new antibiotic through the development pipeline and into the market.  Bacteria can begin developing resistance to most drugs within a year of its deployment in patients. After that, once local resistance to an antibiotic appears in approximately 20% of patients, physicians will cease prescribing it for fear their patient will be one of that 20%.

So, to recap: 10 years, $1 billion; short market life; rapid obsolescence. 

Doctors are calling for urgent global action to prevent the spread of this multi-drug-resistant "superbug" after it has now been found in water supplies in the Indian capital of New Delhi.  A study in The Lancet medical journal said that New Delhi NDM-1 producing bacteria have been discovered in 51 out of 171 samples taken from water pools and rivers and two out of 50 tap water samples in the city.  Positive samples included those collected in and around India, Pakistan and even in Great Britain.

Mohammed Shahid, from the Jawaharlal Nehru Medical College and Hospital in India's northern Uttar Pradesh state, says that potential for a wider, international spread of the superbug was "real and should not be ignored.”  Similarly, the World Health Organization has called for monitoring after cases of infection are being reported around the globe. 

In India, NDM-1 represents a serious problem -- 650 million citizens do not have access to a flush toilet and even more probably do not have access to clean water.  If a tipping point is one day reached in an over-populated city like New Delhi, millions would die.  It’s just a matter of when.

The length of time and cost to bring a drug to market was significantly changed when Congress enacted amendments to the Food, Drug and Cosmetic Act in 1962 to increase FDA oversight of the drug industry. The amendments required firms to show that new drugs were safe and effective before receiving FDA marketing approval.  The procedures for demonstrating safety and efficacy have become increasingly costly.

Studies of that 1962 policy change and other FDA policies have found that more regulations have increased the real U.S. drug development costs by an average of 6 percent per year and have reduced by half the number of new drugs introduced in the United States. Those regulations have also increased the share of U.S. pharmaceutical R&D performed outside the U.S. where reguluations are less stringent.   In addition, they have increased patients' suffering by denying them new drugs and have limited the usefulness of drugs by barring their use in self-medication and in proven but non-FDA-approved treatments.

There is no debate that drugs must be proven safe.  However, as a result of the FDA’s increased regulation of the approval process there have been numerous studies showing no corresponding reduction in the number of harmful or bad drugs.  Drugs were as safe then, as now.  Yet, the cost in increased mortality and morbidity could be valued as high as $1 billion per year.

The government must review its drug approval process to lower costs and help prevent a cataclysmic event where millions could be lost to new superbugs like NDM-1.

About Ed DeShields

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