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PostPosted: Sat Dec 04, 2004 2:18 pm 
http://www.berkshireeagle.com/Stories/0 ... 22,00.html

Particularly,
Berkshire Eagle Online wrote:
This conscientious patriot should be left to do his job, for the statistical evidence certainly suggests that for the past four years the FDA has been generous to a fault in accommodating the food and drug industries that fatten Republican-party accounts. During Bill Clinton's second term, 10 drugs deemed dangerous by the FDA were taken off the market. In the Bush years, just three were, and one of those, Vioxx, was removed voluntarily and belatedly. Warning letters on dishonest drug advertising plummeted, too, from 480 cease-and-desist letters from the second Clinton administration FDA to 130 in the past four years.


I haven't looked for the first term figures, but why only state the figures from Clinton's second term? That seems to me like comparing apples and oranges. What were the similar figures from Clinton's First term?

Are there figures on how many drugs weren't taken off the market even though they were dangerous for both administrations? What if there were less dangerous drugs in bush's era? The whistleblower they're talking about now only listed 5 dangerous drugs for this term, and I'm not sure how many of those were among the 3 pulled. You can't pull more dangerous drugs than dangerous drugs that are in use and exist.

I think the news rags really need to start posting their backing statistics for all of their articles...


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PostPosted: Sat Dec 04, 2004 10:35 pm 
Kazriko wrote:
Particularly,
Berkshire Eagle Online wrote:
This conscientious patriot should be left to do his job, for the statistical evidence certainly suggests that for the past four years the FDA has been generous to a fault in accommodating the food and drug industries that fatten Republican-party accounts. During Bill Clinton's second term, 10 drugs deemed dangerous by the FDA were taken off the market. In the Bush years, just three were, and one of those, Vioxx, was removed voluntarily and belatedly. Warning letters on dishonest drug advertising plummeted, too, from 480 cease-and-desist letters from the second Clinton administration FDA to 130 in the past four years.


I haven't looked for the first term figures, but why only state the figures from Clinton's second term? That seems to me like comparing apples and oranges. What were the similar figures from Clinton's First term?

They were comparing a four-year period to a four-year period. Doing otherwise would be considered statistically dishonest. IIRC, some of the Bush campaign's attacks on John Kerry's voting record used this cheat.

The underlying assumption in this comparison would be that new drugs are coming on the market at a steady rate, at least to the extent that two four-year periods should have roughly the same number of drugs being put up for approval, and that the failure rate should remain more or less constant. Note that the change in both statistics was a factor of 4 to 1 or 5 to 1, not a small percentage change that might be attributed to random chance. If the number of new drugs brought on the market crashed by 75% or more over the course of a couple of years, that would represent a catastrophic collapse in research output for the pharmaceutical industry. I'm sure we would have heard about it.

Kazriko wrote:
Are there figures on how many drugs weren't taken off the market even though they were dangerous for both administrations?...

Any such figures would be highly subjective, unless you had testing resources available roughly comparable to those of the FDA. I'm sure there are anti-medical establishment activists who could provide information on this, but an educated guess/polemic of that sort doesn't have the power to persuade that you get from a dramatic statistical factoid.

Kazriko wrote:
What if there were less dangerous drugs in bush's era?...

Unless someone has clear evidence to the contrary, a steady flow of drugs to the market from industry labs should provide a more or less constant rate of successes and failures. The key figure here is the total number of drugs introduced each year. If it is very small, the chance of variability from year to year is much greater. However, comparing a four-year period to a four-year period during which the technology only incrementally changes should dampen the variability curve even more.

Note that the statistic for the false-advertising warnings is of the same magnitude as the statistic for dangerous drugs. It would seem extremely unlikely that the torrent of advertising the industry puts out got four times as honest after the debut of an pro-business administration that essentially promised them more leeway to lie and cheat if they were so inclined.

As a counter-claim, one could suppose that the FDA under the Clinton administration was overzealous and denied approval to drugs at four times the rate that would have been expected from an objective agency. That would mean that seven or eight of the drugs labeled dangerous in his second term were unfairly labeled, and the companies involved should be seeking to have those rulings changed.

Kazriko wrote:
I think the news rags really need to start posting their backing statistics for all of their articles...

I'm in favor of that, definitely. Of course, as you might expect, my belief is that George Bush would never have been elected President in either election if the major media outlets had actually fact-checked his charges and claims. Many of them were manipulations or outright fabrications; factcheck.org had so many of these falsehoods in their files they put out an entire book on the topic.

I'll note that the two statistics are only part of a larger argument the whistleblower is making, at considerable risk to his future in his field, and that the punishments the administration routinely dishes out to officials who contradict the party line are unethical and dangerously corrupt, even if the whistleblowers are exaggerating or wrong.


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 Post subject:
PostPosted: Sun Dec 05, 2004 3:58 am 
I attribute it to God being with Bush, inspiring medical researchers and making advertisers more honnest.


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 Post subject:
PostPosted: Sun Dec 05, 2004 11:09 am 
Quote:
Unless someone has clear evidence to the contrary, a steady flow of drugs to the market from industry labs should provide a more or less constant rate of successes and failures. The key figure here is the total number of drugs introduced each year. If it is very small, the chance of variability from year to year is much greater. However, comparing a four-year period to a four-year period during which the technology only incrementally changes should dampen the variability curve even more.


Actually, I'm not so sure that it would. There are general trends in the pharmaceutical industry and you see "generations" of drugs; a lot of the same drugs that come out in a given decade are related compounds. These generations usually come with similar risks and benefits.

Also, drugs don't come to market all that often. I question if a four year term is enough time to be an accurate sample size for either president. I think it may well be statisticly meaningless.

Oh and oh yeah, the FDA is corrupt, does not have the best interests of the American people at heart, is incompetent, and needs to be completely rebuilt or abolished. But that's a story for another post and I don't blame it on any given president.


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PostPosted: Sun Dec 05, 2004 2:19 pm 
Berken wrote:
They were comparing a four-year period to a four-year period. Doing otherwise would be considered statistically dishonest. IIRC, some of the Bush campaign's attacks on John Kerry's voting record used this cheat.


I know THAT, but why only ONE four year period for comparison?
Why not give statistics for several periods for the sake of completeness?

Quote:
The underlying assumption in this comparison would be that new drugs are coming on the market at a steady rate, at least to the extent that two four-year periods should have roughly the same number of drugs being put up for approval, and that the failure rate should remain more or less constant. Note that the change in both statistics was a factor of 4 to 1 or 5 to 1, not a small percentage change that might be attributed to random chance. If the number of new drugs brought on the market crashed by 75% or more over the course of a couple of years, that would represent a catastrophic collapse in research output for the pharmaceutical industry. I'm sure we would have heard about it.


Things very well could have changed in the making of drugs with the availability of more powerful supercomputers to do theoretically testing before the fact... Without sufficient information we really can't know for certain, even though this article is trying to lead us one way by showing a handful of statistics that support their point while leaving others that might not off.

Quote:

Kazriko wrote:
What if there were less dangerous drugs in bush's era?...

Unless someone has clear evidence to the contrary, a steady flow of drugs to the market from industry labs should provide a more or less constant rate of successes and failures. The key figure here is the total number of drugs introduced each year. If it is very small, the chance of variability from year to year is much greater. However, comparing a four-year period to a four-year period during which the technology only incrementally changes should dampen the variability curve even more.


See above. Without more statistics on numbers of drugs issued, improved testing technologies, etc... We really can't know for sure. There are way more lurking variables than you're letting on here. All of these are just guesses without having the source data available. When I was reading this page the first time, it threw up every red flag for bad statistics I had. I hate it when people use statistics as a way to support their case without fully exploring whether it may not support their case.

Quote:
Kazriko wrote:
I think the news rags really need to start posting their backing statistics for all of their articles...

I'm in favor of that, definitely. Of course, as you might expect, my belief is that George Bush would never have been elected President in either election if the major media outlets had actually fact-checked his charges and claims. Many of them were manipulations or outright fabrications; factcheck.org had so many of these falsehoods in their files they put out an entire book on the topic.


Nod, although there were fabrications and omissions on both sides. Like the "Tax on the 200,000+ bracket only hurts the rich, not small businesses." Most of those fact-check websites were only checking for falsehoods on the arguments of one side.

Lastly, If the article is true, why are we trusting an organization that can be manipulated through politics to handle something so important. Drug safety, like food safety, like personal safety is too important for the government to handle.


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PostPosted: Sun Dec 05, 2004 3:57 pm 
Kazriko wrote:
Berken wrote:
They were comparing a four-year period to a four-year period. Doing otherwise would be considered statistically dishonest. IIRC, some of the Bush campaign's attacks on John Kerry's voting record used this cheat.


I know THAT, but why only ONE four year period for comparison?
Why not give statistics for several periods for the sake of completeness?

Because We The People have the general attention span of an addled gnat and wouldn't read or care about any issue that presented more than two periods at most?

There's a real need to stop marketing news as the only source of information on any topic, and start making it a gateway that encourages people to seek out their own answers. Unfortunately, the established media have no interest in encouraging such a paradigm shift.


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PostPosted: Sun Dec 05, 2004 9:00 pm 
Kazriko wrote:
Berken wrote:
They were comparing a four-year period to a four-year period. Doing otherwise would be considered statistically dishonest. IIRC, some of the Bush campaign's attacks on John Kerry's voting record used this cheat.


I know THAT, but why only ONE four year period for comparison?
Why not give statistics for several periods for the sake of completeness?

I would hazard that the whistleblower didn't add the extra sentence or two because he was only sampling quotes to reinforcement his case, which he would have given in greater detail in his testimony and report. As a trained scientist, he would be used to that process.

The reporter, of course, should be fact-checking up and down the line. Or, if this was his "beat" as a journalist, he might have had the knowledge already and didn't feel it important enough to put in a short article. Stripping a story down to fit a column is something every journalist must learn to do, even if he never learns the names of all the cabinet members.

Either way, the guy doing the writing should know the answer. This is the sort of thing a reader should be able to ask the media source and the media source should be able to toss back the stats right back to you.The pity is that reporters as a professional have gotten so shallow and biased over the last two decades that it is hard to tell if they have done their report properly.

(Note: for sheer entertainment value of the high-brow sort, try the New York Review of Books. It gives its intellectual elite writers whole columns to fire back volleys at their critics.

Kazriko wrote:
Lastly, if the article is true, why are we trusting an organization that can be manipulated through politics to handle something so important? Drug safety, like food safety, like personal safety is too important for the government to handle.

Who else is there? It’s a tough question.

They tried letting private business handle this sort of thing on the honor system back in the 19th Century and found that the industries as a whole couldn't be trusted. A major share of the drug market was taken up by patent medicines that were useless, at best, and at worst, poisonous to the users. The food industries sold spoiled goods, grain products mixed with substantial quantities of rat filth, dirt, and sawdust, and meat treated with formaldehyde as a preservative.

Unfortunately, raw capitalism often doesn’t work well when the infrastructure is complicated enough to provide cover for unethical providers. Suppose you multiply the volume of sausage you put out by 10% using sawdust as filler. A certain number of people will be made sick or less healthy by this non-digestible material, and others will realize they are being cheated by being charged for something that isn’t really food. However, if you are part of a complex food delivery system, chances are only a few people will trace their illness directly to your contaminated products, and only slightly more will learn that you are selling them ground wood falsely identified as meat.

Now, your company is at the top of the social/political hierarchy and almost all of your customers are at the bottom. You can keep knowledge of your unethical actions from spreading using political and media muscle, even to sending in thugs and lawyers in to harass troublemakers.

Essentially, if you manage the process correctly, honest dealers in food and medicine can’t compete with that 10% advantage you’ve created and are driven out of business or reduced to nuisance shares.

Religious groups have been involved in some cases. For instance, almost all kosher food inspections in this country are performed by trained rabbis employed by government agencies for this purpose. In the 1870s, the Grant administrations tried to battle corruption in Indian policy by appointing idealistic Quakers to many positions in or near reservations. Unfortunately, the forces outside the agency---military men, political appointees, and business interests---proved too powerful for the Quakers to do the work they had been hired for and most of them quit.

Over the course of the last two centuries in America, inspection of food and medicines became duties assigned to city inspectors and state and government agencies because the politically active citizenry felt this was the only way to avoid the risk of being poisoned by the goods they were buying.

In an attempt to make these agencies more trustworthy, some have been replaced by independent boards, the Federal Reserve being the most important. Regulatory agencies like the FDA are considered semi-independent, in that they are staffed by professionally trained civil servants and their day-to-day affairs are in the hands of an appointed board with fixed terms of office. When the system is working properly, there are no direct contacts between the regulatory staff and political appointees and few or no means for businesses to threaten or corrupt agency staff. This provides a reasonably trustworthy watch on unethical businesses. The system, however, can fail if the high-level appointees act as instruments of the political operatives or allow unofficial contacts to be made between staff, and political operatives, and businesses.

In other words, the agency system is designed so it can only be easily corrupted from the top down. If the top people do not believe in the agency’s purpose---remember, they are sworn in specifically to enforce that purpose, as defined by federal statute---then the agency’s effectiveness is compromised. If the top people are also politically corrupt, the agency is crippled.

Ultimately, no government, private, or semi-private regulatory body can do its job if the people in power don’t believe in it. If you don’t have a regulatory body that can enforce standards, the complexity of the industry infrastructure allows thieves and poisoners to flourish.


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