Saturday, September 24, 2011

Government regulation: does it block progress?

The profit-over-everything motive has led to the excesses of factory farming and food production, and the loss of drugs that are simply not profitable enough.

 Grandmere Mimi  discusses the loss of chemotherapeutics because there's just not enough money in it for Big Pharm. Let's face it:  pharma wants money, and orphan diseases and generic cancer drugs are not profitable.  There has to be some subsidy or motivation for them.

Is it all regulation? Oh, evil government, preventing companies from providing products!   With the Republican mantra of "less regulation",we've endured summers of Salmonella in the egg supply, traced to un-inspected facilities, and bad sprouts,and contaminated tomates. This is the result of the "less government" mantra that the right wingers are promoting. This is why people are getting sick.  In countries where people can buy antibiotics without prescriptions, they no longer work--because overuse leads to resistance.

It's fashionable to blame that Big Bad Government for this. So let me tell you a story.

 Back in the 1950s, pregnant women in Europe and Canada were offered a new drug to counteract morning sickness. It worked! And it was widely prescribed. It was never approved by the FDA in this country, however. An FDA inspector, Dr. Frances Kelsey, had some suspicions about it. Free samples had been sent out, but the data seemed incomplete to her--and no one had followed up on the babies born after its use. Although she was pushed by her superiors and the drug company to approve it, she stood her ground. And it was good that she did.

 The drug was thalidomide, and it was a potent teratogen that disrupted normal development. Soon enough, children were born in Europe, Australia, and Canada who had no legs, and flippers in place of arms, and this was linked to the new wonder-drug. The approval process was halted in the US, and the drug was withdrawn by 1962 in other countries. The government in the US did its job. It protected the people, and saved countless children from severe defects.

 I wonder if anyone ever apologized to Dr Kelsey.

 In recent years, thalidomide has been redeemed for usage in leprosy and multiple myeoloma. However, strong safeguards are in place to prevent its administration to women who are or could be pregnant, to prevent further congenital birth defects.

 Our system works by checks and balances. Our government works this way (or used to): executive balances legislative balances judicial. The regulatory processes of government balance the profit driven motives of industry.

 The key is the balance.

 Abolishing regulations completely is good for business. It is generally bad for people. Ask the kids who grew up limbless if the profits were worth it.

1 comment:

Chris H. said...

On the other hand, we have bills that are so complex and convoluted that the people voting on them admit they haven't read/don't know what's in them, or bills that some researchers say would take years to read and understand.

Even the rules that helped protect from thalidomide are causing problems now. I work in a pharmacy and we have non-stop shortages of very common drugs and skyrocketing prices, sometimes because of corporage greed and sometimes because of new regulations. Part of the problem is that some cheap old drug that worked isn't available anymore because it hasn't gone through the modern drug testing approval system so they can't sell it anymore; you have to buy this "new" name brand drug(a very slight remodel of the old) for $50-100 more instead of $6 because they jumped through the years of testing hoops. This has happened to nitro pills for chest pain, gout meds, and asthma inhalers, among other common stuff. One of my pharmacists pointed out that if aspirin went through modern testing it has so many different effects on the body it would still be a prescription.
The real question is- How does anyone balance anything in Washington anymore?