Potentially Incompatible Goals at F.D.A.

[maddezmom]

By GARDINER HARRIS
Published: June 11, 2007
Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe.

These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.

~snip~


In February 2006, one of her safety reviewers, Lanh Green, went to her with a problem. The agency’s Office of New Drugs had asked Ms. Green to determine whether eye problems that sometimes resulted from taking Avandia and a similar drug, Actos, were a serious issue. But Ms. Green noted that visual deficits were just one part of a drug-induced swelling problem that could lead to weight gain, ankle swelling and, if left untreated, heart failure.

Alerts about some of these problems were scattered throughout the two drugs’ labels. Ms. Green suggested consolidating them and highlighting the heart risks with a boxed warning, the agency’s most severe. After a weeklong review, Dr. Johann-Liang agreed.

“There’s no doubt these problems are caused by these drugs, and there’s no doubt that patients are continuing to suffer bad outcomes,” Dr. Johann-Liang said.

A week later, top officials from the new drug office walked by Dr. Johann-Liang’s office and into the office of her boss, Dr. Mark Avigan, she said. Nearly an hour later, she said, the door opened, the officials left and Dr. Avigan called her in.

“Mark told me that they were upset with our recommendation,” Dr. Johann-Liang recalled. “They decided to act like the review never happened.”

more:
http://www.nytimes.com/2007/06/11/washington/11fda.html

[nosmokes]

1. I like the part where Sen Grassley says reforms are needed.

yeah, how about we start with getting big pharma out of the gov't by publicly financing elections so congress isn't writing a medicare drug bill to their specs? how do you feel about that Senator? Because while Dr Avigan looks like the big bad wolf in this article and I'm sure he's no choirboy, there's no doubt in my mind but that he was doing *exactly* as his corporate controlled political bosses told/expected him to do.

[MatrixEscape]

2. As long as ...

the profit motive trumps the care and concern about the patients, i.e., real, feeling human beings, involved in the process, there is always a conflict of interests involved.

Anyone who sees, first hand, or knows somebody working in the field of nursing homes and extended health care is aware that profit is the most important aspect of the services provided and the patients are often as good as cattle on their way to slaughter as far as their value and importance in the process is concerned.

I can honestly say, from what I know that you DON'T want to live to be old enough to be in a nursing home or to be so debiltated that you need that kind of care if you are younger if you are NOT WEALTHY. There is a hell on Earth if you compare what you will experience to any decent life-style you are now enjoying. That hell equally applies to the care givers and the patients because the corporate model dominates the paradigm, ensuring low pay for excellent performance and nearly medieval care across the board for residents, from food to medical attention, to care of the mind and needs of those who are trapped in a profit-motivated, cold-hearted, institutionalized system that has its CEO's, executives, and investors as the primary beneficiaries. Your personal, mental, and physical needs won't matter much once you end up at the other end of the almighty dollar's inferno. However, you can rest assured that, should you become comatose with the capacaties of a tomato, you will be kept alive as long as possible, (and your family's love and desire to not let go will be exploited) in order to assure that your bed space produces profit at the lowest cost possible.

That makes the old saying, "Live fast, die young, and make a good looking corpse!" more tenable by today's uncaring, corporate standards.

Read this article carefully if you are concerned about potential and practical revelations and liberating solutions:

http://www.sensiblyeclectic.com/news/index.php?/archives/5507-On-Becoming-Comfortably-Unplugged.html