In the April, 2008 issue of the Reader's Digest there is a very interesting article called, "Strong Medicine". It is a report on what is ailing the FDA in the U.S. and what it means to those that live in the U.S. I urge anyone who has been putting off stem cell therapy only because the procedure is not FDA approved, to read this article.
Reader's Digest article
- Thread starter barbara
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Until I can get my hands on this article, could you post your "Reader's Digest version" of this Reader's Digest article!!
i.e. what is the synopsis of it?
FDA article recap
Harv - The article is rather a long one, but it starts out with "Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days.....
Many of the nation's leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year old agency learns of dangers too late and then moves too slowly to remedy them.
It goes on to say that insiders say it is woefully underfunded (this seems to be the excuse for many things these days, although with a budget of $2 billion and tasks that include regulation of $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, animals feed and drugs, cell phones, gene therapy and much much more, this could be a good reason), understaffed and fractured by bitter internal tensions. It says Americans are no longer depending on the FDA, they are doubting it and for good reason.
It continues on with some chilling instances of drug safety gone awry. There is also the problem of user fees which the FDA collects from drug companies which in turn many feel puts pressure on the FDA to speed decisions and soft-pedal problems. Some risks of a new drug may not be revealed for years, until thousands or even millions have used it the article says. The article only gets worse as it talks about Ketek, the antibiotic that resulted in many tragedies. The issues surrounding the approval and use of that drug were mind-boggling and it tells the reader why. The article also covers sloppy record keeping, conflicts of interest, muzzled experts and tells us what we can do and what Congress must do. It was a good, although very disconcerting article, especially if you are a great believer in the FDA.
Harv - The article is rather a long one, but it starts out with "Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days.....
Many of the nation's leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year old agency learns of dangers too late and then moves too slowly to remedy them.
It goes on to say that insiders say it is woefully underfunded (this seems to be the excuse for many things these days, although with a budget of $2 billion and tasks that include regulation of $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, animals feed and drugs, cell phones, gene therapy and much much more, this could be a good reason), understaffed and fractured by bitter internal tensions. It says Americans are no longer depending on the FDA, they are doubting it and for good reason.
It continues on with some chilling instances of drug safety gone awry. There is also the problem of user fees which the FDA collects from drug companies which in turn many feel puts pressure on the FDA to speed decisions and soft-pedal problems. Some risks of a new drug may not be revealed for years, until thousands or even millions have used it the article says. The article only gets worse as it talks about Ketek, the antibiotic that resulted in many tragedies. The issues surrounding the approval and use of that drug were mind-boggling and it tells the reader why. The article also covers sloppy record keeping, conflicts of interest, muzzled experts and tells us what we can do and what Congress must do. It was a good, although very disconcerting article, especially if you are a great believer in the FDA.
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I understand.
The FDA does not want to stand in the way of the multi-billion dollar profiteering of the big drug companies, and obviously steps aside so that they can sell their latest drugs. Taking the case of Vitorin/Zetia (which I took) the drug company and FDA knew a year before the data was released that Vitorin/Zetia were bad news. But, they left them alone until a few months ago, and they actually ran television commercials selling Vitorin and Zetia for 9 months, knowing that the bad test result news was coming!! Can you imagine? Padding their bank accounts before the lawsuits started coming.
And, of course, the FDA knew about the whole thing, and should have stepped in and told them that they could not run these ads.
I look forward to reading the article.
FDA mistakes
Harv - You have first hand experience then of what is going on. How horrible this really is. Somehow, this type of thing has become commonplace and people seem to tolerate it for some reason or another until they or someone they know are affected. I urge members to e-mail or call their congressional representatives and tell them that the FDA is in dire need of a complete makeover. At least this will tell you how concerned your representatives are about your own health and welfare or you may find out that they are in bed with the big drug companies too. At any rate, we are the ones that get to vote and we should do that wisely.
Harv - You have first hand experience then of what is going on. How horrible this really is. Somehow, this type of thing has become commonplace and people seem to tolerate it for some reason or another until they or someone they know are affected. I urge members to e-mail or call their congressional representatives and tell them that the FDA is in dire need of a complete makeover. At least this will tell you how concerned your representatives are about your own health and welfare or you may find out that they are in bed with the big drug companies too. At any rate, we are the ones that get to vote and we should do that wisely.
I keep politics out of my posts on this forum, but I can state that I am waiting for a new administration. I personally will not tolerate this babying of the drug companies and their money manufacturing a short time after the current administration leaves Washington. Business as usual is not going to cut it after 2008, at least not if I have any voice.
Donate to your favorite drug company
I do have to agree that Congress appears to be the real culprit here. This has been going on longer than the present administration. No matter where the blame lies, all of us are getting shortchanged and we must demand changes. What is going on at the FDA appears to be nothing more than a charity operation for pharmaceutical companies.
I do have to agree that Congress appears to be the real culprit here. This has been going on longer than the present administration. No matter where the blame lies, all of us are getting shortchanged and we must demand changes. What is going on at the FDA appears to be nothing more than a charity operation for pharmaceutical companies.
A new president CAN influence change for this, it all depends on what is tolerated and what legislative changes are called for and/or demanded. The president can not turn their back on what are the current practices of the FDA and drug companies.
Now...
Whether such legislation after being introduced passes both houses of congress is another matter that the president can not control.
I will personally write, call and email any legislator within my districts and/or state, and suggest that everyone do the same. I will tell them that I demand something different for the FDA and drug companies.
We CAN have something different, it is a matter of how many people demand a change.
Now...
Whether such legislation after being introduced passes both houses of congress is another matter that the president can not control.
I will personally write, call and email any legislator within my districts and/or state, and suggest that everyone do the same. I will tell them that I demand something different for the FDA and drug companies.
We CAN have something different, it is a matter of how many people demand a change.
The FDA has overdosed on pharmaceutical companies
Harv - I am behind your idea completely. The FDA as it is has lost its purpose for existing. The entire operation needs a huge overall and both Congress and the new President must pay attention to this. You hear so much campaigning about health care, but if our health care isn't healthy for people, what's the point? Call, write, e-mail, do whatever, but make some noise people.
Harv - I am behind your idea completely. The FDA as it is has lost its purpose for existing. The entire operation needs a huge overall and both Congress and the new President must pay attention to this. You hear so much campaigning about health care, but if our health care isn't healthy for people, what's the point? Call, write, e-mail, do whatever, but make some noise people.