Saturday, April 26, 2008

Missing evidence in the US presentation

As it did in the run-up to the first US debacle in the Middle East of this century, the Washington Post is putting the pro-War propaganda on Syria and Iran on the front page. Why? War sells papers! Unlike the past, it does include information that challenges the administration. However the facts are buried today on page A12. Here it is: "Missing Evidence in the U.S. Presentation:"

"The Bush administration this week asserted that an Israeli airstrike in Syria Sept. 6 destroyed a nuclear reactor being constructed with the assistance of North Korea... The intelligence community said it had ... "medium confidence" that North Korea was involved, and "low confidence" that Syria had a related weapons program.... The full range of U.S. intelligence information on the site is unclear, but skeptics have pointed to several key uncertainties:
  • No fuel,
  • No repocessing,
  • No electrical power lines, and
  • No weapons design.
It sounds like my golf game: no grip, no stance, no backswing and no follow-through.

Friday, April 11, 2008

Hillary vs. Obama

STOP IT.

I say this as a first-grade student in the year Hillary graduated from college. When everyone said they wanted to be President, I said so too. Even teachers laughed. Imagine the power that gave to the students to deflate the dreams of elementary school girls.


Imagine the derision aimed at the smart, accompished, promising women of Wellsley in 1969, the same year. The year Hillary graduated.

An undated photograph of Hillary Rodham, center, during her days as a student at Wellesley College, from 1965 to 1969.

The women, and the men who benefit from their work, discoveries, and support, who read these words owe those women a debt that can never be paid. If you don't want Hillary, don't support her. But acknowledge this debt.

Saturday, April 5, 2008

One World, One Dream for Hu Jia

This week, a Beijing court sentenced human rights activist Hu Jia to 3 1/2 years in prison for subverting state authority and to one additional year's loss of his "political rights." He was arrested in part for co-authoring, with Teng Biao, an open letter on human rights. The Washington Post prints Human Rights Watch's translation of the Sept. 10, 2007, letter descriing the imprisonment, torture, censorship, forcible removal form homes, and exile of hundreds of thousands of people in Beijing and China.

Thursday, March 20, 2008

Qualify your vendors: Heparin from China

FDA has user fees to review drug applications but this administration has forced budget cuts that have decimated it's ability to inspect manufacturing plants not just for drugs, but for devices, biological products, food, and veterinary medicine. FDA inspectors wait until the agency can bundle up foreign establishment inspections, and then only give FDA inspectors a few days in each site to spot-check records.

That means facilities must police themselves.

Instead, the Heparin contamination is just another example of how US companies have downsized their operations and their Quality units to please shareholders, and now these companies obtain many of their components from the third world where corruption is common, contamination from dirty water and unhygienic practices is unavoidable, and subcontractors think nothing of exchanging expensive ingredients and equipment with unacceptable replacements. US companies don't know their vendors, they don't adequately audit them, and they don't know where their vendors get their supplies, either. This despite the fact that the idea of qualifying vendors has been around since 1951.

WSJ writes without much new insight that "The recent problems with heparin from China highlight the difficulty of monitoring the often diffuse and poorly regulated supply chains there -- for both Chinese drug makers and the multinational pharmaceutical companies that buy from them."

Like many regulated companies, this one falls into the trap of bragging that it built a new "GMP facility;" then fails to make sure the people and products brought into its new walls are free from contamination.

WaPo quotes William Hubbard, a former FDA official, who says it is not surprising that tainted drugs supplied though agency-approved channels are showing up from abroad. "The history of some of these developing countries in terms of substituting or counterfeiting concerns is a long and well-documented one," he said. "And at this point, the FDA doesn't have the resources or system in place to make sure some of these bad drugs don't get through to the public."

In the meantime, FDA budget is still a fraction of NIH's, and increases for FY09 are barely enough to cover cost of living adjustments, and certainly won'y allow improvements in inspections. Even industry wants to give FDA more money.

Sunday, February 24, 2008

The John Edwards Effect on Clinton, Obama and the DNC

According to the NY Times, John Edwards' policies are running for President. Ironically, Universal Health Care may be more his legacy than Obama's or even Clinton's.

As the architect of these policies, Edwards deserves a place to bring them to reality. He has the ability and courage to do this.

To understand the extent of the Edwards effect, you have to think about what might have been.

At the beginning of 2007, it seemed likely that the Democratic nominee would run a cautious campaign, without strong, distinctive policy ideas. That, after all, is what John Kerry did in 2004.

If 2008 is different, it will be largely thanks to Mr. Edwards. He made a habit of introducing bold policy proposals — and they were met with such enthusiasm among Democrats that his rivals were more or less forced to follow suit. It’s hard, in particular, to overstate the importance of the Edwards health care plan, introduced in February.

Before the Edwards plan was unveiled, advocates of universal health care had difficulty getting traction, in part because they were divided over how to get there. Some advocated a single-payer system — a k a Medicare for all — but this was dismissed as politically infeasible. Some advocated reform based on private insurers, but single-payer advocates, aware of the vast inefficiency of the private insurance system, recoiled at the prospect.

With no consensus about how to pursue health reform, and vivid memories of the failure of 1993-1994, Democratic politicians avoided the subject, treating universal care as a vague dream for the distant future.

But the Edwards plan squared the circle, giving people the choice of staying with private insurers, while also giving everyone the option of buying into government-offered, Medicare-type plans — a form of public-private competition that Mr. Edwards made clear might lead to a single-payer system over time. And he also broke the taboo against calling for tax increases to pay for reform.
Suddenly, universal health care became a possible dream for the next administration. In the months that followed, the rival campaigns moved to assure the party’s base that it was a dream they shared, by emulating the Edwards plan. And there’s little question that if the next president really does achieve major health reform, it will transform the political landscape.

* * * *

Furthermore, to the extent that this remains a campaign of ideas, it remains true that on the key issue of health care, the Clinton plan is more or less identical to the Edwards plan. The Obama plan, which doesn’t actually achieve universal coverage, is considerably weaker.

One thing is clear, however: whichever candidate does get the nomination, his or her chance of victory will rest largely on the ideas Mr. Edwards brought to the campaign.

* * * *

If Democrats manage to get the focus on their substantive differences with the Republicans, ... polls on the issues suggest that they’ll have a big advantage. And they’ll have Mr. Edwards to thank.