Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, March 06, 2009

Canada-US Project : A Blueprint for SPP on Steroids

But first : a quiz !
Can you spot the main difference between the two pictures below?
Take your time ... don't rush it ...






[The answer is in comments.]

In the top picture, Harper is holding the latest Canadian foray into deep integration : From Correct to Inspired : A Blueprint for Canada-US Engagement from the Canada-US Project.

Appearing with him are Canada-US Project luminaries (L to R) Colin Robertson, on loan from the Department of Foreign Affairs and International Trade to Carleton University to direct the project; Fen Osler Hampson, Canada-US Project co-chair and director of the Norman Paterson School of International Affairs at Carleton University; and Derek Burney, former Canadian ambassador to the US and co-chair of the Canada-US Project at Carleton. Burney and Robertson are also SPP and NAFTA alumni.

Contributors to the "blueprint" include Thomas D'Aquino of the Canadian Council of Chief Executives; Perrin Beatty of the Canadian Chamber of Commerce; three former American ambassadors to Canada : David Wilkins, James Blanchard, and Gordon Giffin; and serial Canada-basher Michael "Canada blew it!" Hart.

"Blueprint" authors Fen Hampson and Michael "Canada blew it!" Hart appeared before the Standing Committee on Foreign Affairs and International Development on Feb 23 to complain that the Canada - US relationship has :

"an awful lot of informal, below-the-radar relationships," Mr. Hart said.
"I mean hundreds of relationships among officials and so on, but none of that is provided with a kind of from-the-top political guidance as to what the objectives are."
The two professors went on to say Canada must redefine its relationship with the U.S. in a way that will strengthen security but also enhance trade.
Ideally, they recommended broadening, among other things, NORAD to create a secure land, sea and air perimeter around North America, while dropping the national border to create a Schengen-type arrangement.

The Schengen Area is a group of twenty-five European countries which have abolished all border controls between each other.

Two days later Thomas d'Aquino of the Canadian Council of Chief Executives told the Commons' Foreign Affairs committee on Feb. 25 that the North American Security and Prosperity Partnership "is probably dead." However something else will inevitably replace it, he said.

The Canada-US Project is certainly making a good run at it.

Here's some not altogether random quotes from their above-mentioned "Blueprint for Canada-US Engagement" :

  • The two governments should re-examine the benefits of a perimeter approach to the border.
  • The two governments should also take a blowtorch to regulatory differentiation and overlap that serve no useful purpose other than to preserve some government jobs and to perpetuate a preference for differentiation for its own sake.
  • On Afghanistan : Canada certainly has earned the right in blood and treasure to influence stronger US leadership and to spur a more substantive, more cohesive international effort.
  • Domestically, the enthusiasm that greeted the election of Obama will fade in the face of the persistent unease of Canadians about getting too close to Canada’s giant neighbour.
    Crisis, a convergence of national interests, and the need for economic recovery should help to bring us together. Canadians are ready ... They accept that the border has become dysfunctional and that minor regulatory differences make little sense.
    Obstacles to achieving this agenda are chronic indifference in Washington and wariness or narcissism in Canada.
  • Redefining the way the two governments manage the interoperability of Canadian and US forces is an important next step. Putting NORAD on a permanent footing was a start, but there is a need for appropriate institutions for land and maritime forces as well.
  • Canada’s role in Afghanistan is proving critical to re-establishing its credentials as a credible security partner. The government will need to be prepared to offer help in other trouble spots.
  • As Obama takes office, he will pursue a faster drawdown in Iraq with compensatory emphasis on Afghanistan. This may put pressure on the prime minister’s vow to take Canadian combat troops out of Afghanistan by 2011. Cutting Canada’s losses on a costly and unpopular mission may prove popular at home but will at the same time reduce Canadian influence and visibility with a new administration.
  • The most pressing bilateral issue is the need to re-think the architecture for managing North America’s common economic space.
    Re-imagining the border
    . ... the border has become an instrument to address yesterday’s problems. It may be time to resurrect the “perimeter” concept and find a better balance between security and economics. Integrating national regulatory regimes into one that applies on both sides of the border. But to make this work, the two governments must also develop joint rules and procedures to coordinate regulatory policy on an ongoing basis.
  • Building an enhanced capacity for joint rule making. The two governments may need to establish a few institutions that are capable of providing political leadership as well as political oversight.
  • Part of the solution may lie in making better use of the “hidden wiring” in the relationship. Over many years, relations have grown and deepened at many levels – from the state-provincial and business-to-business to nongovernmental, and legislative levels.
  • [I]t is not in Canada’s best interests to restrict energy exports to the United States at this time – a situation that will remain unchanged for quite a number of years.
  • The third major challenge is to bring the rules governing the cross-border movement of goods and services into line with the reality of deep integration. Border security has become economic protectionism in a new guise.
    Additionally, it is critical that the two governments find a joint approach to border management in the event of a major terrorist attack in either the United States or Canada. There is no agreed contingency plan to deal with such a crisis.
  • Finally, the smooth operation of the integrated Canada-US economy requires that the two countries come to grips with what some have called the narcissism of small differences in the regulatory structures of the two countries. Health Canada spends an enormous amount of time and money testing drugs that have already been tested and approved by the US Food and Drug Administration.
    North American economic integration has grown and an enhanced Canada-US trading relationship needs to reflect that reality. Canada can speed the process of convergence by making a concerted effort to align a wide range of regulatory requirements with those in place in the United States.
  • [O]nly Canada’s inveterate anti-Americans can take satisfaction in seeing their neighbours in such trouble. The over-hyped talk among the pundits about the death of the American market economy model is nonsense.

Apparently their polls that show that "Canadians are close to unanimous (95 per cent) in their desire to see the federal government strengthen the relationship with the United States", hindered only by "the chattering classes" - a rather odd reference given that co-author Derek Burney is Chairman of the Board of Canwest Global Communications Corp. - but doesn't all this sound like a blueprint for SPP on steroids to you?

OK, on to the exciting quiz answer in comments ...

Cross-posted at Creekside

Sunday, March 04, 2007

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.