Thoughts on thoughts . . .

THE HUMAN BRAIN is astoundingly complex, according to a report on ScienceDaily, "Human Brains Share a Consistent Genetic Blueprint and Possess Enormous Biochemical Complexity". Indeed, the human mind is astoundingly complex in both construction and operation. Scientists at the Allen Institute for Brain Science reported in the latest issue of the journal Nature that human brains share a consistent genetic blueprint and possess enormous biochemical complexity. The findings stem from the first deep and large-scale analysis of the vast data set publicly available in the Allen Human Brain Atlas.

And while we all don't think alike, our minds are all pretty much the same:This dataset profiles 400 to 500 distinct brain areas per hemisphere using microarray technology and comprises more than 100 million gene expression measurements covering three individual human brains to date. Among other findings, these data show that 84% of all genes are expressed somewhere in the human brain and in patterns that are substantially similar from one brain to the next.
• 84% of all genes are expressed, or turned on, somewhere in the human brain.
• Many previously uncharacterized genes are turned on in specific brain regions and localize with known functional groups of genes, suggesting they play roles in particular brain functions.

But it's when brains malfunction, that is of concern. Psychoanalysis is a process of conjecture, when contending with human minds and their mysterious motivations, and as the West became urbanized, it appeared that more and more people were experiencing mental maladjustment, indeed, head problems.

Then Miltown, or Meprobamate was discovered in 1950, launched in 1955, the first blockbuster psychotropic drug. Right after, came Thorazine, or chlorpromazine, and the side-effects blossomed, as the "thorazine shuffle" became the gait of the afflicted.

And Big Pharma jumped in on this with both feet. 

Decades later, the effectiveness of these psychotropics is being rightly questioned.

THE WILSON QUARTERLY is a delightful, thoughtful site, with a wonderful article by Tanya Marie Luhrmann, "Beyond the Brain", which looks at the failure of the pharmaceutical industry to deal with schizophrenia:

In the 1990s, scientists declared that schizophrenia and other psychiatric illnesses were pure brain disorders that would eventually yield to drugs. Now they are recognizing that social factors are among the causes, and must be part of the cure.
• • •
Psychoanalysis and even psychotherapy were said to be on their way out. Psychiatry would focus on real disease, and psychiatric researchers would pinpoint the biochemical causes of illness and neatly design drugs to target them.
• • •
Yet the outcome of two decades of serious psychiatric science is that schizophrenia now appears to be a complex outcome of many unrelated causes—the genes you inherit, but also whether your mother fell ill during her pregnancy, whether you got beaten up as a child or were stressed as an adolescent, even how much sun your skin has seen. It’s not just about the brain. It’s not just about genes.

But orthodox medical people are slow to change, and the prescription drug abuse and damage is becoming even more of a problem, according to Dr. Peter Breggin, whose web site, Psychiatric Drug Facts is a useful compendium of information and ideas, including his latest book, "Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists, Patients and their Families". So, why should you care? Because information and knowledge are your best defence against the horrors that could be prescribed for you or those you love.

The Therapeutic Drug Initiative sends out a final warning

From the CBC a story warning about a blood thinner.

A new blood thinner is easier to use to prevent blood clotting and strokes, but researchers in B.C. caution it may pose serious risks for some patients.

The Therapeutic Drug Initiative at the University of British Columbia is world renown for spotting dangerous drugs. In BC the group has saved taxpayers $50 million annually helping to keep dangerous drugs out of BC pharmacies. The provincial funding was $1 million per year. It's easy to understand why Big Pharma doesn't much like the Therapeutic Drug Initiative.

Gordon Campbell, the premier who resigned and then appointed himself interim leader, has gifted the people of BC with a new deal - he's killed it, and he's made sure the researchers who have staffed the TDI are not allowed to involve themselves in any new drug review process in BC. 

Campbell and the orks which occupy the BC cabinet table have caved, and I mean totally caved, to Big Pharma. From Friday's Time Colonist:

The walls of the Therapeutics Initiative are papered with accolades and letters of support from around the world. A leading medical journal called it "the only source of critical assessment of new treatments in Canada that is not political or partisan." Another commendation referred to the Therapeutics Initiative as "one of the best sources of information about pharmaceuticals ... in the world."

But no good deed goes unpunished. Drug companies have been lobbying for years to get rid of the agency.

It's worth considering the various motives involved. The Therapeutics Initiative's job is to disbelieve anything it hears about a drug until evidence can be found to support it. That makes it an industry critic. 

And of course pharmaceutical firms want to sell their products. They are on the other side of the fence.

But where does this leave the provincial government? Sitting on the fence -- until a few days ago. 

For some years, a succession of health ministers tried to square this circle: How to placate the drug industry, which is a major contributor to the Liberal party, without gutting the Therapeutics Initiative. 

[...]

The Ministry of Health has just outlined a new assessment process. First, the Therapeutics Initiative will have no further role. Its funding is terminated. 

Second, whereas the drug industry had no voice in the old system, it will have extensive influence in the new one. Conflict-of-interest rules have been substantially weakened. And the industry has been given four separate points of engagement. 

Third, in what can only be considered an act of spite, staff at the Therapeutics Initiative are to be kept off the new drug benefit council that will manage the process. The experts who ran Canada's most successful drug review program have been told they are not wanted.

Any questions? The Campbell government isn't interested in your health. They are bought and paid for by their dollar contributing big business buddies.

Bedpans or Bombs? Decisions, Decisions . . . .

Wow!

With savings like this nearly 20 more wars could be funded.

Maybe a debate between Big Pharma/Big Insurance and the Military/Industrial Complex is in order.




Let the campaign donations begin . . . .



(Cross-posted from Moved to Vancouver)

Before you eat that USDA Prime steak, read this.

Unless you've had a severe respiratory or food-borne infection you have probably never heard of cefepime. It's a fourth-generation cephalosporin antibiotic forming the last line of defence in humans suffering from specific food-borne multiple drug resistant strains of bacterial infections. It is administered with great care because the last thing we would want is for bacteria to successfully mutate enough to render cefepime ineffective.

The Bush administration is about to do just that. (Emphasis mine)

The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.

You might want to stop for a minute to understand that the division of drug classes means that the most potent and effective are held exclusively for use by medicine to combat microbiological mutations that occur after treating animals with a lower class or generation of drugs.

The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.

It would stand to reason then, that the US Food and Drug Administration would simply reject the sale and deployment of cefquinome on the basis of an increasing health risk to humans. It's what used to happen. But, no, things have changed and the reason is horrifying.

Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented "guidance document" that codifies how to weigh the threats to human health posed by proposed new animal drugs.

The wording of "Guidance for Industry #152" was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs like cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization.

Right. Because the World Health Organization is a part of the United Nations and Bush doesn't need a hall pass from the UN... for anything.

"The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open."

Make no mistake about it. The industry we're talking about here is big pharmaceutical companies. It's the manufacturers of the drugs who are pushing this. While cattle ranchers, I'm sure, would like to reduce the mortality rates of their herds due to pneumonia with a stronger drug, it is big pharma trying to cash in that is driving this. And the logic they use would never have worked twenty years ago. They would have had to prove no risk from use of a drug in animals to humans. The new Guidance #152 places the onus on the FDA to prove that a risk to humans exists. In other words, the drug companies are willing to err on the side of their ability to market a product which they do not know will not cause a microbiological mutation and pass on food-borne infections to humans. Because they don't know it and the FDA cannot state categorically that it will, the FDA, under its new guidance, must approve use of the drug.

The FDA knows how hard it can be to close that door. In the mid-1990s, overriding the objections of public health experts from the Centers for Disease Control and Prevention (CDC), the drug agency approved the marketing of two drugs, Baytril and SaraFlox, for use in poultry. Both are fluoroquinolones, a class of drugs important for their ability to fight the bioterror bacterium that causes anthrax and a food-borne bacterium called campylobacter, which causes a serious diarrheal disease in people.

Before long, doctors began finding fluoroquinolone-resistant strains of campylobacter in patients hospitalized with severe diarrhea. When studies showed a link to poultry, the FDA sought a ban. But while Abbott Laboratories, which made SaraFlox, pulled its product, Baytril's manufacturer, Bayer Corp., pushed back.

"They fought this tooth and nail. It took years," said Kirk Smith, an epidemiologist at the Minnesota Department of Health.

Finally, late in 2005, Bayer gave up, but not before fluoroquinolone resistance had spread even further.

There's the dig. It's already happened in a different class of drugs. The fact that one of the big pharmaceuticals was defiant in the FDA's attempt to withdraw Baytril demonstrates the lack of concern they actually have for the health of the populations they sell to.

InterVet developed cefquinome to treat bovine respiratory disease, the most common disease in cattle. Recognizing the potential public health implications of using a close cousin of cefepime in animals, the FDA's Center for Veterinary Medicine, which oversees animal drug approvals, convened its expert advisers in September.

One of the first things the group learned was that more than a dozen medicines are already on the market for the respiratory syndrome, and all are still effective.

"If we have no susceptibility problem, why do we need one more new drug?" asked James E. Leggett Jr., a professor of medicine at Oregon Health & Science University, whom the FDA brought in as a consultant on the cefquinome question.

So, why a new drug? Because a drug company wants to position itself in the marketplace as having the most effective defence against bovine respiratory diseases, which develop as a result of cattle being kept in tightly confined spaces and being shipped thousands of miles in cramped rail cars. The FDA, however, wasn't allowed to point that out and had to stick to the language of Guidance #152.

A related problem is that the guidance's definition of "food-borne" is conservative, said Margaret Mellon of the Union of Concerned Scientists, a science policy advocacy group. For example, most urinary tract infections are caused by intestinal bacteria acquired from food, and cefepime is prescribed for those infections. If the FDA counted those infections as food-borne, then the guidance's formula would call for rejecting cefquinome for cattle.

"But FDA didn't do that," Mellon said. "That restricted the analysis right there."

Moreover, the guidance does not take into account that when microbes become resistant to fourth-generation cephalosporins, they often gain resistance to third-generation versions, too.

In short, the veterinary pharmaceuticals fully intend to proceed and the FDA with the new guidance document is virtually powerless to stop them.

How many times have we heard Bush, Cheney or any other of a number of Bush administration mouthpieces state that the first job they have is the protection of the American people?

Yeah, it wasn't believable then either.

More at Robert Prior.

Thanks to reader Cat.