FDA Commissioner Margaret Hamburg issued notice yesterday that the FDA is going to be laying down the law. It has been oft-noted here on Eye on FDA that enforcement by the FDA has certainly been lax during the Bush Administration and that improvement should be expected. In her statement yesterday, Commissioner Hamburg made clear precisely how she is directing for enforcement to pick up again. There is no question that there will be greater scrutiny and greater action more quickly as a result.
Her objective is clearly to speed up enforcement actions and to remove some of the obstacles that made timely enforcement all but impossible under the old-FDA mindset. She has outlined six initial steps toward that end:
Setting up post-inspection deadlines – giving companies a 15-day deadline to respond to issues or get a warning letter;
Speeding up the Warning Letter process – no longer reviewed by Office of Chief Counsel unless there are significant legal issues;
Work more closely with FDA’s regulatory partners – i.e., state and local officials;
Faster assessment of corrective actions taken after warning letters;
More immediate responses to public health risks – possibly even before a warning letter is issued;
Developing a “close out” to the Warning Letter process that is posted by FDA to the web site when issues are resolved.
“Health reform is a test of whether this country can function once again as a civil society — whether we can trust ourselves to embrace the big, important changes that require everyone to give up something in order to make everyone better off. Republican leaders are eager to see us fail that test. We need to show them that no matter how many lies they tell or how many scare tactics they concoct, Americans will come together and get this done.” Republicans Propagating Falsehoods in Attacks on Health-Care Reform
Civil society is composed of the totality of voluntary civic and social organizations and institutions that form the basis of a functioning society as opposed to the force-backed structures of a state (regardless of that state’s political system) and commercial institutions of the market.
It is the third group, besides the government, which has the power to use force to achieve things, and the power of business, which has the power to spend money to achieve things. The members of civil society really only have the collective power of numbers to fight the power of government and business.
And for the last 300 years, it has been the most powerful of the three groups. The Age of Enlightenment gave us the tools to empower civil society and allowed us to harness these groups to help the people.
We seem to have lost that power of the civil society. Today, we see certain areas of business and government working to undermine a civil society, to reduce its power while they maintain their own. They do this by spreading lies whose only purpose is to create a bunch two-year olds that only scream ‘No.’
Screaming at each other does not help the civil society. It only provides greater power for certain aspects of government and business. The great breakthough of the Age of Enlightenment was discovering ways to give the civil society greater control of the government and business branches. Permitting these two groups to divide the civil society reduces this control.
Fixing the healthcare problem is not something started by government or business. Those trying to fix the problem are doing so as a result of what people want – at least the majority do. At least those who are adult enough to realize the current system is not sustainable, who realize that other countries will rapidly begin to surpass us in most measures of healthcare, who realize that the strongest civil society is the one where the weakest are protected, not the strongest.
We knew that once. We could disagree but remain civil. We could allow each other to speak without drowning them out with hate. Not much anymore.We have been too divided by the machinations of a few in government and business.
They are the ones who gain power by dividing civil society.
This is really the point, because the healthcare system is broken and unsustainable. It has to be fixed. Yet due to the lies spread by vested interests, one side refuses to engage in a reality-based process to fix it. Simply screaming ‘No’ like a two-year old does not produce any sort of solution to the problem at all. They have been saying ‘No’ for over 20 years but at some point it has to be fixed.
One group acts like adults, trying to find a solution, and another group acts like children who want their diapers changed. I think that a civil society is getting to be largely a pipe dream. Maybe the adults will get the children to stop screaming long enough to change the diapers but it is still more likely that a lot of crap will get thrown around.
Thank God, we actually had a semblance of a civil society at one time so that Social Security and Medicare were passed. Two government-run programs that I am certain few of the children screaming now would want to repeal.
When I hear about idiotic animal rights people arguing against animal research, I always say we should just forbid them from getting any drug that was tested using animals – no antibiotics, cholesterol lowering medication, no heart medicine, no stents, no hip transplants, nothing. We don’t because we are still, mostly, a civil society.
Same with these children. If they hate the idea of a government-run healthcare program, lets remove them the Medicare rolls and prevent them from ever receiving Medicare. Maybe that will actually produce a sustainable program for the adults who realize its importance.
But we won’t do that because we are still, mostly, a civil society. We will give people antibiotics, even while they try and prevent the development of drugs. And we will provide people with Medicare, even while they try to prevent its application to all Americans..
But for how much longer? Will the greatest gift of the Age of Enlightenment, from our Founding fathers – the removal of supreme power from despots and cheats, and its harnessing by civil society – final fade away, with the return of monarchs and plutocrats? Sometimes, I fear that is likely to happen. We have been on the path for some time now. Can that trajectory be forestalled?
Arctic sea ice extent for the month of July was the third lowest for that month in the satellite record, after 2007 and 2006. The average rate of melt in July 2009 was nearly identical to that of July 2007.
The data continues to look discouraging. Not only was the rate of sea ice melting almost as great as the record year of 2007, it was almost 13% greater than last year. The amount of ice in the Arctic in July was the third lowest on record, continuing the trend seen over the last 30 years that has resulted in a 20% reduction in the ice extent.
Remember, this only examines sea ice extent, not volume. All the data indicate that this ice is much thinner than it used to be, meaning that a large amount of volume has disappeared over the years. Having the same extent of ice but being only a few feet thick versus a few yards can have huge effects on overall conditions.
“Karianne’s Pet” by Carl Buell. The large animal in the painting is the hyaenodontid Megistotherium osteothlastes, a contender for the title of biggest carnivorous mammal ever.
As explained in an earlier post (which you may be interested in reading as a bit of background to this one), the earlier part of the Caenozoic (the current era of the earth’s history) was home to a number of mammalian lineages of very mysterious relationships. Very few of the familiar orders around us today had yet put in an appearance, and instead the world was home to such oddities as pantodonts, tillodonts and dinocerates. Among the prominent carnivorous mammals of the time were a group known as the creodonts. Creodonts ranged in size from that of a small cat to lion- or bear-size species, and often converged in appearance with those animals. But what were creodonts?
Current authors regard the Creodonta as including two families, the vaguely cat-like Oxyaenidae and the largely dog- or hyaena-like Hyaenodontidae. Oxyaenids were found in North America and Europe during the late Palaeocene and Eocene, while hyaenodontids were found in Africa, Eurasia and North America from the Late Palaeocene to near the end of the Miocene, though they disappeared from North America not long after the end of the Eocene (Gheerbrant et al., 2006). Many authors have suggested a relationship with modern carnivorans (cats, dogs, weasels, bears, etc.), and they have been included with the latter in a superorder Ferae. Popular as this arrangement has been, however, there’s just one small problem – there’s not a shred of evidence to support it.
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A wonderful post demonstrating why taxonomy at lower levels and biological systematics at higher levels can be so troublesome. we just do not have enough information about some extinct species to make an accurate call.
And his explanation for taxonomic drift is excellent and why taxonomy requires a tremendous depth of knowledge in order to keep things straight. Because even though researchers may be using the same names, they may be describing separate species.
It does make me wish some creodonts survived. Wouldn’t it be nice to have one as a pet?
But I love this site. It describes the results of taxonomic drift thusly:
Eventually, the creodonts were whittled down to their modern content of oxyaenids and hyaenodontids, but, as pointed out by Polly (1996), “Hyaenodontidae and Oxyaenidae are currently grouped together in Creodonta because they are the only taxa that have not been removed from the group, not because there has been specific positive evidence proposed for their grouping”.
[snip]
The only real reason creodonts have been associated with Carnivora for so long seems to be their prior inclusion of the genuinely carnivoran (or stem-carnivoran) miacids. It’s a bit like when one of your friends brings an acquaintance of theirs to a party who just hangs around for hours with everybody being too polite to ask them to leave.
So the group stays with carnivores only for historical reasons, not for any real reason of relatedness. Sounds like an area ripe for new investigations. I wonder if any DNA can been recovered from creodont fossils? Probably too old.
It’s only taken two weeks to go from the blog posts shredding McLean et al to a paper submitted to the Journal of Geophysical Research. The authors are G. Foster, J. D. Annan, P. D. Jones, M. E. Mann, B. Mullan, J. Renwick, J. Salinger, G. A. Schmidt, and K. E. Trenberth and the abstract says:
McLean et al. [2009] (henceforth MFC09) claim that the El Niño/Southern Oscillation (ENSO), as represented by the Southern Oscillation Index (SOI), accounts for as much as 72% of the global tropospheric temperature anomaly (GTTA) and an even higher 81% of this anomaly in the tropics. They conclude that the SOI is a “dominant and consistent influence on mean global temperatures,” “and perhaps recent trends in global temperatures”. However, their analysis is incorrect in a number of ways, and greatly overstates the influence of ENSO on the climate system. This comment first briefly reviews what is understood about the influence of ENSO on global temperatures, then goes on to show that the analysis of MFC09 severely overestimates the correlation between temperature anomalies and the SOI by inflating the power in the 2-6 year time window while filtering out variability on longer and shorter time scales. It is only because of this faulty analysis that they are able to claim such extremely high correlations. The suggestion in their conclusions that ENSO may be a major contributor to recent trends in global temperature is not supported by their analysis or any physical theory presented in that paper, especially as the analysis method itself eliminates the influence of trends on the purported correlations.
This is how science works. A published paper is critiqued and its faults revealed by further publications. As time goes on, a better model of the natural world emerges.
That is how it is supposed to be done.Truth is not decided by who shouts the most, who is the most frightening or who has the best PR machine. Openness and transparency help prevent the distortion of facts.
Facts are facts. If someone has to rely on the use of incorrect approaches in order to change the facts, then that should be revealed. And that is what Science always attempts to do.
Just wish some other areas where facts are important could be as easily dealt with. But then, most scientists have to be rational in order to keep their jobs, while in some careers, rationality is a handicap.
I’m not shedding too many tears over the tsunami of bad press the Australian Vaccination Network (AVN) is receiving right now.
I’ve written about them before, oh yes. They are the ones headed by Meryl Dorey, the woman who says vaccinations are dangerous, who says no one dies of pertussis, who says that it’s better not to vaccinate, who insinuates (at the 11:50 mark of that video) that doctors only vaccinate children because it’s profitable for them. She says that, even though on that live TV program she sat a few feet away from Toni and David McCaffery, parents who had just lost their four week old daughter to pertussis because she was too young to be vaccinated yet and the herd immunity in Sydney was too low to suppress the pertussis bacterium. This year alone, three babies in Australia, including young Dana McCaffery, have died from pertussis.
Not enough parents are vaccinating their children. And groups like the AVN spread misinformation about vaccines, spread it like a foul odor on the wind.
I hope the full force of the law is brought to bear against this people. Their lies result in people dying. Misrepresent facts and children will die.
By spreading misinformation about vaccinations the AVN is scaring parents. The herd immunity is low in part because parents are scared to vaccinate their children. The low herd immunity is killing babies. It really is just that simple.
The works of vaccine denialists are responsible for low vaccination rates which remove the herd immunity that provides so many people protection.
I wonder when we left the Age of Enightenment and entered the Age of Ignorance? We have little hope of surviving the challenges ahead of us if willful ignorance is the primary choice made by so many.
But I guess ignorance is more comforting then actually engaging with the complexities of the real world.
Fixing our health care system is critical for the United States, not only because it might be the humane thing to do but also in order to maintain a competitive economy. 15% of our GDP pays for healthcare and this is projected to raise to about 20% by 2017. Our health insurance premiums have more than doubled in 10 years. We pay more than any other developed country while insuring a smaller portion of the population. Over 50% of all personal bankruptcies are due to medical expenses, something that is not even possible in most developed countries.
Health care costs to businesses are increasing much faster than profits, resulting in the mathematical certainty that either total health insurance costs to businesses will become greater than total profits or even more people will be without health care. Businesses in most other countries do not have the burden of paying healthcare out of their profits, making it easier for them to be profitable.
Finally, health insurance costs raise each year but at an unknown rate. It is quite difficult for most businesses, especially small ones, to forecast just what their health care costs will be each year. This adds another problematic layer for the financial health of small companies.
These should all be part of any debate on health care reform in this country. But we are not seeing that. What we are seeing are the same sorts of bullying, astroturf tactics that have been used before by vested interests to stop debate and to stop the democratic process.
They do not have any interest in our real health concerns. They are concerned solely about maintaining their profits.
Astroturf may be fraud. But it is used constantly by lobbying groups, and others with vested interests.
Rachel Maddow has been doing a great job reporting on the history of this fraudulent approach and who is behind its current usage against health care reform.
Here is some history – the Brooks Brothers riots:
These supposed average citizens were actually operatives hired to be provocative. It worked in 2000 and has only become more sophisticated with online approaches.
These same tactics are now being used across the country in a way that is again designed to shut down debate. In fact, the use of these tactics was delineated in a leaked memo. There is no attempt to carry on any discussion. It is purely to intimidate through the use of violent, angry mobs that can only be called hooligans.
More on orchestrated outrage, with some discussion of the leaked memo describing just what to do to rattle the speaker:
I am sure there are many people who are really angry and acting on their own. But much of their anger is being whipped up by lies spread by groups who want no changes to be made at all in health care, by groups that are quite happy with the bankrupting of our economy, by groups that exist to take money in order to stop debate. It does not happen in a vacuum.
It happens because specific people are spreading known lies in order to provoke others to act out their anger. Although it started with busing of people around to town halls, this meme has spread far enough that it no longer strictly needs constant nourishing. Just like any marketing scheme that takes a life of its own, this deliberate spread of lies to stop debate now needs little care. Just some added lies to keep things going.
“This is professional, corporate-funded, Republican-staffed PR and should be reported as such.”
Liberals have had their own recent incidents where they shamefully tried to stop someone from speaking but I have not seen anyone demonstrate that this was part of a nationwide plan put together by left-wing vested interests and political operatives.
That is what we seem to have here using corporate lobbying groups and political operatives. Normally, most people are not really interested in what happens at the national level. They care about their day to day life and local issues. It takes some real effort to rile them up. Spreading lies works quite well. It always has.
I’ve seen this same approach, this same reliance on generating anger, used by creationists. I personally have been yelled at and talked over in the same intimidating way by people riled up by their minister with lies. It was at a debate on creationism and evolution where I was a member of the audience. I had a question for the speakers. Turns out several Baptist churches had bused over their parishioners to fill the hall.The goal was not to convince me that evolution did not happen. The goal was to shut me up and intimidate anyone else who might agree with me. The feeling that I might now be recognized by crazies who would beat the crap out of me in the parking lot very much made me wish I had not stood up.
I know how easy it would be for any organized effort to rile up a large group of people. And what a negative impact it really has on actual discussion of ideas.
It may be average people doing a lot of this now but the marketing plan has been put together by lobbying organizations paid for by the healthcare industry and insurance companies.
So now we have a group of angry, scared people that no longer wants to actually debate and find a solution. The discussion has degraded to the worst kind of democracy – people yelling at each other. On something we have to solve.
We cannot keep going on the path we are on now. But many vested interests are happy to see America fail as long as their profits continue.
