FDA Scraps Helsinki Declaration

FDA Scraps Helsinki Declaration on Protecting Human Subjects

The FDA formally declared that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration.

The new rule, which goes into effect next October, was supported by the drug industry but opposed by numerous public interest, patient advocacy, and consumer groups.

The new rule requires only that trials conducted abroad by drug manufacturers follow good clinical practices (GCP) and include a review and approval by an independent ethics committee.

There's nothing in GCP guidelines that requires patients in the control arm of a trial get access to already proven therapies.

Has the U.S. become entirely callous about the impact its ill-conceived policies are having on the rest of the world?
http://www.gooznews.com:80/archives/001052.html

Oh that is truly bad news Less and less guarantees for the participants (and later patients) and protocols to adhere to here.

This is not good!

This article explains the significance of the FDA decision.
http://www.nature.com/embor/journal/v7/n7/full/ 7400743.html

Some critics have said that clinicians, consumers and payers need to know whether or not a new treatment is better than other existing comparable treatments, not a (is this better than nothing) placebo.

The trials with people in this instance are ones who ought to be on some sort of medication. So providing them with nothing, rather than an existing drug, is a serious situation.

It's been an ethical question for a long time here in the United States. Some cannot see that anyone would do something so unethical as set up a trial that did not offer the chance at the current standard of therapy versus a new drug.

Being on a placebo for a few months means that a cancer seriously can progress to the point that treatment would no long benefit them. No thanks! I'd skip clinical trials.

There are some medical oncologists utilizing cell-based bio-markers for years in their managment of their cancer patients that feel it is unethical not to use them, as opposed to "trial-and-error" treatment. Science is in the eye of the beholder. If you know something works better than nothing......

Being on a placebo for a few months means that a cancer seriously can progress to the point that treatment would no long benefit them.

Exactly!!! Medical ethics should, in principle and in legal relation, protect people against being misused!!

On assignment for the Scientific American, Merrill Goozner traveled to Romsk, Russia on the western edge of Siberia to get their perspective on the issue of major pharmaceutical companies increasingly moving their clinical trials to countries like this one.
http://science-community.sciam.com/blog-entry/Sciam- Observations/Fda-Drops-Ball-Patient-Rights/570003206

Well, it looks like that is going to change as well and requires more transparency into sponsors etc. before committing to clinical trials in Russia.

A poster at another website stated that on the one hand, the FDA refuses to allow Stage IV cancer patients to take experimental drugs even though they're dying anyway, but at the same time, they'll allow drug companies to conduct clinical trials that don't provide participants with the minimum to survive and/or prolong survival. Where's the consistency?

gpawelski, not being an American, I wonder where are the patient representative groups that are supposed to ask those questions (and get answers) from the very top in government deciding (or giving their authority) to let such inconsistencies exist?

Over the last seven and a half years, America's government has been run by a "business-friendly" republican president, where the belief is that the business of America is "business." The "stealth" policy put out by this administration is that the FDA shouldn't cite anything they don't absolutely have to and cutting or under-funding oversight budgets. A policy that looks after the "profits" of companies before the "safety" of our citizendry.

One example of an enforcement shift has been the drop in FDA warning letters. In 2001, the FDA sent out 1,032 of the letters. In 2007, that fell to 471. The number of warning letters has always been one of the surrogate measures of FDA's enforcement performance. The decline followed a policy shift when the FDA started sending all warning letters through its office of chief counsel.

Since the inception of this administration, it has installed more than 100 top officials who were once lobbyists, attorneys or spokespeople for the industries they oversee. High-level officials who helped govern industries they once represented. These former industry advocates have helped government agencies write, shape or push for policy shifts that benefit their former industries.

They know which changes to make because they had pushed for them as industry advocates. These political appointees made or oversaw profound changes affecting drug laws, food policies, land use, clean-air regulations and many other key issues. Government ethics standards are part of our problem because they don't fully address the kind of issues that have permeated Washington over the last seven and a half years.

Wow, that is such a gloomy development Is there any chance that those changes can be reversed would another administration come to exist following elections? This can't be good. There must be someone who can do something about these obvious worsening of public (health is public) safety? I know everywhere in the world health benefits are getting worse (instead of better, strangely enough) like in the Netherlands I always knew dental care to be cost free and now is not included in the health package insurance anymore - but that is ONLY money, this - what you write above here - is directly endangering people's health (rather chance to be cured). This is real bad...

Is there any chance that those changes can be reversed would another administration come to exist following elections?

That's the million dollar question!!!

We'll see!

Are there any promises being made during these presidential campaigns at all?

Here's an article that caused a buzz a couple of months ago after it was picked up by Google:
http://www.cancermonthly.com/iNP/view_printer.asp? ID=208

By the way, this is a very informative cancer website:
http://www.cancermonthly.com/

Wow - that is a very strong article. The end-message to "mr. presidential candidate" should be published over and over again, until the next president of the U.S. cannot but oblige to this.