Comments on: The FDA Is A ‘Fundamentally Broken Agency’ http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/ News, Comment and Conversation Fri, 10 Feb 2012 21:55:05 +0000 http://wordpress.org/?v=2.6.2 By: Justice in Michigan http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-124104 Justice in Michigan Thu, 31 Jan 2008 04:32:48 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-124104 Jaynesday - There has been no shortage of discussion of preemption here. Look it up on the search engine. It happens that my "moniker" is all about that as well. Michigan is the only state in the country that has had a full FDA preemption regime for twelve years. Thus, no Michigan citizens have been able to have a day in court related to any of the drugs that have been withdrawn, or had serious warnings added, since 1996. Add 'em up. If the current Supreme Court rules as is most likely given recent appointees, we are your future. Jaynesday - There has been no shortage of discussion of preemption here. Look it up on the search engine. It happens that my “moniker” is all about that as well.

Michigan is the only state in the country that has had a full FDA preemption regime for twelve years. Thus, no Michigan citizens have been able to have a day in court related to any of the drugs that have been withdrawn, or had serious warnings added, since 1996.

Add ‘em up. If the current Supreme Court rules as is most likely given recent appointees, we are your future.

]]> By: Jaynesday http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-124040 Jaynesday Thu, 31 Jan 2008 03:25:42 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-124040 To me the trends don't look good at all. What we want is not people being injured or killed by products that we buy in good faith. The trends are: Adverse events continue to climb each year, including deaths. It is documented that some Drug companies hide the bad results in their pre and post market studies. It is documented that 1/3 of the scientists in the FDA report that they are pressured to falsify reports in an effort to get drug/devices to market. It is documented that the FDA lacks the money, personell, computer systems and skill to protect the American public. All of that is scary to say the least but have you heard about Preemption? Given all of the above I find it extremely concerning that we stand on the edge of the elimination of product liability if the Supreme Court rules so this spring. Preemption is based on the fact that once the FDA approves the product no further challenge to the product's safety is allowed. Does that make any sense? You're telling me that I should: 1. Trust the Drug/Device Companies to design, test, manufacture and market their products with safety as their number one concern not profit. Evidence says otherwise. 2. Expect the FDA to be able to insure that all products introduced for sale are without a doubt, NO QUESTIONS ASKED, safe to consume. Not going to happen any time soon. 3. Feel safe and if something bad happens to me or my loved ones in the course of using a drug/device, just accept my fate and trust that the folks did the best they could with what they had??? To me the trends don’t look good at all. What we want is not people being injured or killed by products that we buy in good faith. The trends are:
Adverse events continue to climb each year, including deaths.
It is documented that some Drug companies hide the bad results in their pre and post market studies.
It is documented that 1/3 of the scientists in the FDA report that they are pressured to falsify reports in an effort to get drug/devices to market.
It is documented that the FDA lacks the money, personell, computer systems and skill to protect the American public.
All of that is scary to say the least but have you heard about Preemption? Given all of the above I find it extremely concerning that we stand on the edge of the elimination of product liability if the Supreme Court rules so this spring. Preemption is based on the fact that once the FDA approves the product no further challenge to the product’s safety is allowed. Does that make any sense? You’re telling me that I should:
1. Trust the Drug/Device Companies to design, test, manufacture and market their products with safety as their number one concern not profit. Evidence says otherwise.
2. Expect the FDA to be able to insure that all products introduced for sale are without a doubt, NO QUESTIONS ASKED, safe to consume. Not going to happen any time soon.
3. Feel safe and if something bad happens to me or my loved ones in the course of using a drug/device, just accept my fate and trust that the folks did the best they could with what they had???

]]> By: ol cranky http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-123323 ol cranky Wed, 30 Jan 2008 21:35:31 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-123323 Methinks Lord is off his ever-loving rocker. Have you forgotten about the collusion in price fixing; the multiple joint development/licensing agreements; mergers & acquisitions? The free market is not really so free when it comes to prescription meds and the industry has proven time and time again it can not be trusted to police itself (mind you, the FDA has done a right crap job policing pharma too). Justice has the right idea, though I would add that we should split up the FDA so that field auditors can focus on an area of expertise. Methinks Lord is off his ever-loving rocker. Have you forgotten about the collusion in price fixing; the multiple joint development/licensing agreements; mergers & acquisitions? The free market is not really so free when it comes to prescription meds and the industry has proven time and time again it can not be trusted to police itself (mind you, the FDA has done a right crap job policing pharma too). Justice has the right idea, though I would add that we should split up the FDA so that field auditors can focus on an area of expertise.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-123119 Justice in Michigan Wed, 30 Jan 2008 21:02:10 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-123119 Good cow, Lord! Have you been reading Newt or somethin I never understood big gov v. small gov - just right sized gov. To (a) privatize FDA and also (b) insure transparency, have gov. ethics and oversight, clear requirements, etc etc. to me simply to create redundancy probably a larger public system to oversee the private one - and a lot of nooks and crannies where stuff could be hidden, along with a probably irresitable lures to corruption as we already see with CROS, etc.. Let's start with an agency at least able to do the job for which it was mandated. Good cow, Lord! Have you been reading Newt or somethin

I never understood big gov v. small gov - just right sized gov. To (a) privatize FDA and also (b) insure transparency, have gov. ethics and oversight, clear requirements, etc etc. to me simply to create redundancy probably a larger public system to oversee the private one - and a lot of nooks and crannies where stuff could be hidden, along with a probably irresitable lures to corruption as we already see with CROS, etc..

Let’s start with an agency at least able to do the job for which it was mandated.

]]> By: Lord Rupert Everton http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-123075 Lord Rupert Everton Wed, 30 Jan 2008 20:24:40 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-123075 Instead of controlling the industry, we need to have faith in the free market system. At the same time, we also need legislation to protect consumers and hedge against the greed of big pharma. I think it would make sense to dismantle FDA and make it private. In order for drug companies to get approval, they would have to pay higher fees based on the market. In conjunction with federally mandated requirements for private drug monitoring, government ethics and medical oversight committees would have to ensure the accountability and transparency of these private approval firms. Therefore, instead of funding a growing number of FDA employees, reduce the number to a staff of oversight commissioners that will cover private industry regulation for drug companies. It sounds crazy, but can we see a future of bigger government? Big gov only leads to more disappointment. Instead of controlling the industry, we need to have faith in the free market system. At the same time, we also need legislation to protect consumers and hedge against the greed of big pharma. I think it would make sense to dismantle FDA and make it private. In order for drug companies to get approval, they would have to pay higher fees based on the market. In conjunction with federally mandated requirements for private drug monitoring, government ethics and medical oversight committees would have to ensure the accountability and transparency of these private approval firms. Therefore, instead of funding a growing number of FDA employees, reduce the number to a staff of oversight commissioners that will cover private industry regulation for drug companies. It sounds crazy, but can we see a future of bigger government? Big gov only leads to more disappointment.

]]> By: SPRI http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-122395 SPRI Wed, 30 Jan 2008 15:07:25 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-122395 I don't believe that the major problem is the FDA itself, although they obviously have some issues. I think that the most problematic item is that the FDA has to deal with unscrupulous companies day after day after day. These companies are always trying to get away with anything they can. If they're asked to do a post-marketing study, they drag their feet. if a study is done and they need to report within one year, they make it two. They attempt to promote using off-label information. They push the envelope on their ads. If the companies did what they were supposed to do and could be trusted, then the FDA might be able to tackle their job. I believe that we need to go back to the days when science and medicine drove Big Pharma companies instead of marketeers and executives driven by greed and self-interest. As it is now, the need to meet or beat the street expectations is king, but patient health should be. here's a radical idea - control them like utilities on a national scale. I don’t believe that the major problem is the FDA itself, although they obviously have some issues. I think that the most problematic item is that the FDA has to deal with unscrupulous companies day after day after day. These companies are always trying to get away with anything they can. If they’re asked to do a post-marketing study, they drag their feet. if a study is done and they need to report within one year, they make it two. They attempt to promote using off-label information. They push the envelope on their ads. If the companies did what they were supposed to do and could be trusted, then the FDA might be able to tackle their job.

I believe that we need to go back to the days when science and medicine drove Big Pharma companies instead of marketeers and executives driven by greed and self-interest. As it is now, the need to meet or beat the street expectations is king, but patient health should be. here’s a radical idea - control them like utilities on a national scale.

]]> By: ol cranky http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-122271 ol cranky Wed, 30 Jan 2008 14:09:58 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-122271 RTW: I'm not so sure the problems stem from companies having to placate shareholders. Even privately owned companies have a board of directors and, nowadays, the boards of the private companies are comprised of the VCs who put up the capital, who want a huge return on their investment. Very few of these have any direct experience with pharma development and little, if any, understanding of the regulations that govern the industry. Combine them with the very unscrupulous executive management who show a willful disregard to regulations and management techniques used to protect themselves under the guise of plausible deniability (& the dreaded finger pointing) and you have the mess we're in today. This being said, the execs still need their lapdogs and other minions to do their dirty work. Most of those people are willing participants who do get big rewards for doing their master's bidding and many of them take great joy in retaliating against "trouble makers" who urge caution or question non-compliant activities. RTW:

I’m not so sure the problems stem from companies having to placate shareholders. Even privately owned companies have a board of directors and, nowadays, the boards of the private companies are comprised of the VCs who put up the capital, who want a huge return on their investment. Very few of these have any direct experience with pharma development and little, if any, understanding of the regulations that govern the industry. Combine them with the very unscrupulous executive management who show a willful disregard to regulations and management techniques used to protect themselves under the guise of plausible deniability (& the dreaded finger pointing) and you have the mess we’re in today.

This being said, the execs still need their lapdogs and other minions to do their dirty work. Most of those people are willing participants who do get big rewards for doing their master’s bidding and many of them take great joy in retaliating against “trouble makers” who urge caution or question non-compliant activities.

]]> By: Justice in Michigan http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-121378 Justice in Michigan Wed, 30 Jan 2008 05:26:07 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-121378 I totally agree with RTW re: the majority of people who work in pharma, and particularly on the science side, but not only. I'd say the same of FDA. Incredible people doing med, stat, etc. reviews. But some scuz in senior management. As RTW suggests, there is a very delicate tipping point. But once you get there, you can take out a lot of people very quickly. A lot of this is unavoidable because unpredictable. And a lot of it is not. When Ray Gilmartin (former Merck CEO if anyone possibly doesn't know) visited our business school ten days after the Vioxx withdrawal (had been planned months before), he denied there was anything to learn from it at all. It was a statistical anomaly, the 18 month business, his wife took it (he didn't assess his marriage), yada yada. That many people go down, and there is nothing to learn? Yes, I understand that in the immediate legal circumstances, it had to be denial, denial, and denial. But I got the sense, up close and personal, that he truly believed it. I think we need the equivalent of truth and reconciliation hearings in South Africa. It is the only way we will ever seriously address how much to know, and learn, there really is. Take liability off the table for a while. It will save a lot of people in the longer run. I totally agree with RTW re: the majority of people who work in pharma, and particularly on the science side, but not only. I’d say the same of FDA. Incredible people doing med, stat, etc. reviews. But some scuz in senior management.

As RTW suggests, there is a very delicate tipping point. But once you get there, you can take out a lot of people very quickly. A lot of this is unavoidable because unpredictable. And a lot of it is not.

When Ray Gilmartin (former Merck CEO if anyone possibly doesn’t know) visited our business school ten days after the Vioxx withdrawal (had been planned months before), he denied there was anything to learn from it at all. It was a statistical anomaly, the 18 month business, his wife took it (he didn’t assess his marriage), yada yada.

That many people go down, and there is nothing to learn? Yes, I understand that in the immediate legal circumstances, it had to be denial, denial, and denial. But I got the sense, up close and personal, that he truly believed it.

I think we need the equivalent of truth and reconciliation hearings in South Africa. It is the only way we will ever seriously address how much to know, and learn, there really is. Take liability off the table for a while. It will save a lot of people in the longer run.

]]> By: RhetRx http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-121253 RhetRx Wed, 30 Jan 2008 03:49:30 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-121253 So....could someone explain to me why it is Pharma insists that we _can't_ trust drugs that are imported from Canada, but we are supposed to be perfectly fine with drugs that come from uninspected plants in a country that has a track record of using whatever ingredients happen to be cheap? I would love an explanation that is based on scientific evidence rather than "one action hurts our pricing strategy and the other helps it". Rhet So….could someone explain to me why it is Pharma insists that we _can’t_ trust drugs that are imported from Canada, but we are supposed to be perfectly fine with drugs that come from uninspected plants in a country that has a track record of using whatever ingredients happen to be cheap?

I would love an explanation that is based on scientific evidence rather than “one action hurts our pricing strategy and the other helps it”.

Rhet

]]> By: LILI http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-121169 LILI Wed, 30 Jan 2008 02:18:36 +0000 http://www.pharmalot.com/2008/01/the-fda-is-a-fundmentally-broken-agency/#comment-121169 WE DO NOT HAVE THE SAFEST DRUG MARKET IN THE WORLD. DOCTORS ARE NOT THE TV COMMERCIALS WARNINGS---TELL YOUR DOCTOR IF YOU EXPIERENCE THESE SIDE SIDE EFFECTS. TELL YOUR DOCTOR HE SAYS NO. YES THE MEDICAL PROFESSION, HEALTHCATE INDUSTRIES AND PHARMACEUTICALS ARE RUNNING THIS COUNTRY. MEW JERSEY IS THE MOST EVIL WHEN IT COMES TO PATIENT CARE. THE 2004 PATIENT SAFETY ACT WAS NOT FOR THE PATIENTS PROFESSION AND BIG PHARMA. ALL WASTING TAXPAYERS MONEY. BLAME IT ON ELECTED AND APPOINTED OFFICALS WHAT THIS COUNTRY NEEDS IS LEADER LIKE MARTIN LUTHER KING. ! WE DO NOT HAVE THE SAFEST DRUG MARKET IN THE WORLD. DOCTORS ARE NOT THE TV COMMERCIALS WARNINGS—TELL YOUR DOCTOR IF YOU EXPIERENCE THESE SIDE SIDE EFFECTS. TELL YOUR DOCTOR HE SAYS NO. YES THE MEDICAL PROFESSION, HEALTHCATE INDUSTRIES AND PHARMACEUTICALS ARE RUNNING THIS COUNTRY. MEW JERSEY IS THE MOST EVIL WHEN IT COMES TO PATIENT CARE. THE 2004 PATIENT SAFETY ACT WAS NOT FOR THE PATIENTS PROFESSION AND BIG PHARMA. ALL WASTING TAXPAYERS MONEY. BLAME IT ON ELECTED AND APPOINTED OFFICALS WHAT THIS COUNTRY NEEDS IS LEADER LIKE MARTIN LUTHER KING. !

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