Wednesday, November 13, 2013

Why government needs regulation

Disclaimer: this post will take a Hobbesian view of humans by saying that generally they are concerned with their own self-interest and advancement.

The recent Johnson & Johnson lawsuit concerning their inappropriate marketing of the antipsychotic drug Risperdal marks the "third-largest pharmaceutical settlement in United States history and the largest involving the marketing of antipsychotic and anti-seizure drugs to older dementia patients" according to the NY Times. The suit also marks the largest whistleblower payout in US history with the four whistle blowers receiving as much as $167.7 million according to CNN Money.

Here are some facts about the conditions of the suit:

  • Risperdal's primary function is to treat schizophrenia. Johnson & Johnson ignored FDA regulations by marketing Risperdal to children before the FDA approved its use in children and outright defied the FDA by expanding their market to geriatric patients even after the FDA rejected the company's legal attempts to market to older consumers.
  • Johnson & Johnson is not pleading guilty to the civil suit that they paid doctors off to prescribe the drug more frequently than necessary. 
  • The company knew of the possible side-effects that Risperdal could cause in patients, especially children and geriatric dementia patients, yet marketed the drug extensively.
  • Risperdal was among Johnson & Johnson's highest revenue-producing products. "In 2004, for example, Risperdal brought in $3.1 billion in sales, accounting for about 5 percent of Johnson & Johnson's total revenue that year, according to company filings"(Thomas, 2).

  • Johnson & Johnson will pay criminal fines amounting to about $485 million and civil penalties of $1.72 billion. This totals to about $2.2 billion that Johnson & Johnson will pay to "put the chapter to rest" and hide the marketing scandal.

So why do I say that regulation is necessary and that humans are essentially selfish creatures?

The executives at Johnson & Johnson knew that the drugs they were marketing were not the safest they could possibly be because they ran in to trouble with the Food and Drug Administration when they attempted to expand their market legally. BUT they tried to poke holes in the system to get what they wanted at the expense of people who can't defend themselves effectively. They didn't care that they were endangering people by marketing Risperdal. Thankfully, the system caught up to them and forced the company to compensate for the damages it had caused. Without this regulation in place, Johnson & Johnson could have continued to harm innocent people for the sake of profit.

Maybe it would be more effective for me to say that government needs whistleblowers? (I think the whistleblowers were also acting out of self-interest - I doubt all of them would have come forward if they weren't getting a reward for their actions. I like to hope that they would have but I'm not certain). For all intents and purposes FDA regulation was dodged fairly easily until four people not associated with the government came forward and revealed Johnson & Johnson's wrongdoings. Then regulation started to work again, as exemplified by the lawsuit.   




2 comments:

  1. Big corporations should be monitored more heavily as they are the ones who have money they can throw around and find illegal ways of avoiding or attempting to avoid the scrupulous eye of the law.

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  2. It would be great if more TV shows and movies featured warnings that advised audiences of their philosophical underpinnings. With Hobbes, it is important to remember that the original argument for regulation was a conservative, law and order one: people are selfish, and we need a strong authority to keep them in check. The problem is that the authority can become cosy with those it regulates, at which point it is not clear what is the right course of action.

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