Posted on 06/01/2005 2:55:49 AM PDT by FairOpinion
Almost 13 years after the Food and Drug Administration made it easier for companies to speed life-saving medicines to patients, US Representative Edward J. Markey says the system of accelerated drug review is ''broken" and fails to protect patients.
Markey, Democrat of Malden, said he came to that conclusion after reviewing documents he requested from the FDA and the Securities and Exchange Commission detailing whether drug companies conducted required clinical trials and reported that information to shareholders.
Under legislation he expects to introduce next week, drug companies could face millions of dollars in fines if patients are harmed because tardy trials keep some health risks from being publicized. The proposed legislation would require drug companies to change the wording on labels to indicate that the safety and efficacy of conditionally approved products have not been proven.
(Excerpt) Read more at boston.com ...
An exxcellent relevant editorial:
Protecting us from the good things?
http://www.townhall.com/columnists/JohnStossel/js20050601.shtml
It's natural to fear freedom. Tell most Americans that we'd be better off if we clear-cut the regulatory jungle and simply let the market decide what products are sold, and you're likely to be told how dangerous the world would be. Most people think government keeps us safe. It's why the Food and Drug Administration (FDA) is regarded as absolutely necessary. It protects us from snake-oil sellers. Who could argue with that?
I will, because years of consumer reporting have taught me that the regulators, by protecting us from bad things, protect us from good things, too. When we let the government use force to limit our choices, we deprive ourselves of innovation that makes life better. Even genuinely compassionate officials can literally regulate us to death.
Some years ago, the FDA held a news conference and proudly announced, "This new heart drug we're approving will save 14,000 American lives a year!" No one stood up at the press conference to ask, "Doesn't this mean you killed 14,000 people last year -- and the year before -- by keeping it off the market?" Reporters don't think that way, but the FDA's announcement did mean that. Thousands will die this year while other therapies wait for approval.
You may want to wait. Many of us want to be absolutely sure a drug is safe before we take it. It's natural to want the "experts" to protect us. But why isn't the choice left to us? Why does the FDA get to force us to wait and, in some cases, die, when there are experimental drugs, however risky, that might save our lives?
Health ping
Catch 22. Speed it to market but if someone is harmed you get nailed by the same gov that ordered you to speed it to the market.
All this will do is slow things down again. Nothing good ever came from Mass politicians.
FDA should ADVISE, but not have the final say, whether a drug is available or not.
There are lots of medications that have been in use in Europe, helping people for years, that the FDA won't approve in the US, because they demand that all studies be redone in the US. This is ridiculous.
Nothing is without risk.
First of all we need some serious tort reform, then the decision should be between the doctor and the patient, weighing hte benefits against the risks.
Nothing is without risk.
First of all we need some serious tort reform, then the decision should be between the doctor and the patient, weighing hte benefits against the risks.
I guess these drugs have saved to many lifes and the Democrats are upset about that.
Democrats think the government should force private companies to conduct their studies or not, instead of leaving the decision to the companies.
The FDA wants to control us completely.
There are MANY drugs that FAIL the tests. We do not know which are good BEFORE the tests.
Are you proposing the release of ALL trial drugs for public use WITHOUT testing? Sure it will make them cheaper - the costs of testing will be carried by the users.
It's natural to want the "experts" to protect us. But why isn't the choice left to us?
So you want the drug companies to produce drugs, sell them and not to be responsible for the results?
Unfortunately, bottom line is not patients' health, but $$$ in many cases of fast tracked drugs.
Perfect example, recently fast track of Tysabri (MS drug), company knew there were deaths involved, but insiders of one company sold stock days before the announcement was made to the FDA (the company withdrew the drug voluntarily at that time.)
Stockholders took the hit financially.
Ms patients who had been in the trials or taken the newly released drug were left to deal with the questions, which still have not been answered about whether or not the drug or a combination of that drug and another were the cause of the deaths.
Correction, the Democrats want to control us completely.
ping
The Microsoft model of software development applied to drugs. Except the Blue Screen of Death is the light at the end of the long tunnel.
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