Industry: "Regulatory Incentives languish" for safety and efficacy

The gold standard in the regulated product industry, The Gold Sheet (Vol 43, No 1) has some advice for Regulatory and Quality staff. (RAQA are those staffers who told Peanut Corp of America that it would be illegal and dangerous to sell deadly contaminated peanut butter. ) Last month's Gold Sheet says death and jail is not enough to stop criminal profiteers - RAQA now has to show how complying with the law saves money. Why? because "regulatory incentives languish."

That means for the last 8 years, FDA has not been allowed to do its job. And regulated companies know it.

"FDA officials encourage industry to concentrate on the business benefits of [Quality by Design or] QbD. [Controlling manufacturing or] CMC pilot [program]s raised questions about cost effectiveness."

Peanut Butter and Salmonella, explained

When a product tests out of its specification, the product must be quarantined. That is why specifications exist.

The peanut butter made by the Peanut Butter Corporation of America tested positive for salmonella. It should have been quarantined.

• That doesn't mean it can never be used. The manufacturer can investigate the cause under a plan.
• The manufacturer can find out what was the root cause of the problem.
• The manufacturer can fix the root cause, and may even recondition the food if the plan will eliminate the contamination.

What the manufacturer cannot do, is simply retest to see if another result will be produced. This has been prohibited by law for at least the past 15 years. But that's exactly what PCA did.
How many manufacturers simply retest? Under the current system there is no way to know. FDA, and the public health, depend on employees of the manufacturers themselves to stand up to marketing, sales, and even Presidents and CEOs, to prevent the shipment of contaminated foods, drugs, and devices. Some employees report to corrupt companies in corrupt countries far away. In this US facility, emails from PCA employees disclose a battered staff trying hard to get their company heads to follow the law. These employees are just a paycheck away from not working. This is a one of several gaping holes in the safety net.

FDA has no authority to recall many products without company approval.

FDA needs investigators now.

Is FDA finally free from politically driven decisions?

Just days after the inauguration, exciting projects that had been frozen for political reasons - even after researchers answered all safety and efficacy questions - are now underway.

One project has the promising goal "to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."

Freezing this research that would help spine injured patients and their families was not the only significant politically motivated FDA action during the previous administration. For example, Plan B was delayed only to become the first and only over-the-counter product for preventing unwanted pregnancy that had a different standard for sexually active patients based on their age alone.

Susan Wood, the head of the Office of Women's Health protested, and payback was that women's health was de-funded. Wood then resigned.

Then-Commissiner Crawford admitted he had delayed approval of Plan B, a product that proved it prevented high-risk pregnancies and saved patient lives. The criminal investigation of the Commissioner was revealed in 2006, shortly after he had resigned in September 2005. He had been confirmed by the Senate for less than three months as the permanent FDA commissioner, a position which he had held on an “acting” basis for a couple of years. It turned out he invested in companies with applications pending at FDA.

More FDA Changes: New Acting Commissioner, more allegations

WSJ: The new Acting Commissioner is Food and Drug Administration Chief Scientist Frank Torti.

Dr. Frank Torti, the FDA's science chief, is set to become its acting commissioner. President-elect Barack Obama and his transition team could announce a permanent
appointee to lead the FDA in the next three weeks, sources said. Wall Street Journal, (subscription required) (01/12)

William Gimson III, chief operating officer at the CDC, will serve as acting director after Dr. Julie Gerberding leaves the agency Jan. 20.

Torti will have his hands full right away - nine device scientists report being pressured to approve unsafe and ineffective products. In the letter, the scientists described an agency where President Bush's FDA managers "ordered, intimidated and coerced scientists to manipulate their research results in violation of federal law."

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.

Sacrificing Science and Consumer Health

Toxins, Trailers and Unsafe Toys allowed by the administration:

Delay Of Report Is Blamed On Politics

CHICAGO -- The lead author and peer reviewers of a government report raising the possibility of public health threats from industrial contamination throughout the Great Lakes region are charging that the report is being suppressed because of the questions it raises. The author also alleges that he was demoted because of the report. Chris De Rosa, former director of the division of toxicology and environmental medicine at the Agency for Toxic Substances and Disease Registry (ATSDR), charges that the report he wrote was a significant factor in his reassignment to a non-supervisory "special assistant" position last year. The House Committee on Science and Technology is investigating De Rosa's reassignment, in light of allegations that it was related to the Great Lakes report and his push to publicize the possibility of a cancer risk from formaldehyde fumes in Federal Emergency Management Agency trailers housing victims of Hurricane Katrina.

Product Safety Regulator Hobbled by Decades of Negligence

The nation's premiere consumer product regulator, the U.S. Consumer Product Safety Commission (CPSC), has been crippled by budget cuts and staffing losses that now span decades. Every president since Gerald Ford has proposed cutting the agency's budget at least once, and Congresses controlled by both parties have obliged.

Recent attention surrounding massive product recalls, including contaminated Christmas toys this past year, prompted Congress at the end of 2007 to give the agency one of its biggest funding boosts, and lawmakers are considering additional legislation to ensure consistent long-term funding. President Bush's FY 2009 budget request, announced Feb. 4, proposes level funding for the agency.

US, China Gang up for Greenhouse Gases; World Boos

China, the country that tortures monks, and the US, the country that tortures just about anyone else, joined forces to protect those who pollute and poison the world's residents at the Greehouse Gases Reduction Conference in Bali this week.


When unauthorized parallel meetings were held
at the Conference of 187 countries, leader Yvo de Boer, not known for his emotion, was overcome by jet lag and obstructionism and burst into tears.


According to the UK's Daily Mail:

Officials from China, which feels Western countries should do more to reduce their greenhouse gas emissions, accused UN negotiators of ignoring conference protocol.

Mr de Boer, distinctively dressed in a floral shirt, stepped up to the microphone to defend his staff - only to find that the words would no longer come.
As his unfinished sentences trailed away, he broke down and walked off the platform to supportive applause.

"He wasn't just wiping his eyes, he was in floods of tears," said one observer.
"Three colleagues - one of them a woman - formed a protective group around him and escorted him out of the hall. It was all very dramatic."
Mr de Boer's breakdown came after nearly a fortnight of squabbling over proposals to cut carbon emissions.

Then there was piling by the US, recently overtaken by China for the spot of World's #1 Greenouse Gas polluter. US delegation chief Paula Dobriansky , a pretty face with an ugly message, was booed for refusing to support the Conference goals.


One delegate, from Papua New Guinea, pleaded with the US to lead on the issue. "Lead, follow, or get out of the way."

More info:

NYTimes

Sunday Mirror

Telegraph here and full coverage here

Celsias

Taxes used to fund STDs for your kids

Are Administration scientists the only ones who aren't reading the data?

Talking to your kids about anything is a great idea, and talking to them about sex is an even better idea. However, telling them to wait until marriage may not only get them to roll their eyes and tune out, but studies show those who pledge to wait till marriage merely exchange vaginal intercourse for more risky behavior. Nevertheless, in another occasion of thumbing his nose at science, the Bush administration yes-men at the Department of Health and Human Services are wasting your tax dollars on a TV advertisement for just this kind of behavior.

"[T]eenagers who take "virginity pledges" ... are more likely to engage in oral or anal sex than nonpledging virgin teens and less likely to use condoms once they become sexually active..."

The study, which began producing results as long ago as 2004, shows these pledgers are sexually active but don't understand the continuum of risk among sexual behaviors including oral and anal sex and sex with professional sex workers.

Here's a pix below from the video, and the ad is available here:




According to Medical News Today,

The gap between pledgers and nonpledgers for high-risk behavior was statistically significant, with 2% of virgins who did not pledge reporting engaging in anal or oral sex, compared with 13% of those who did pledge [a 650% increase] (Washington Post, 3/19). According to [study scientist Hannah] Bruckner, the pledgers' increased likelihood of substituting oral or anal sex for vaginal intercourse puts them at risk of contracting STDs, according to Bruckner. Among virgins, boys who had pledged abstinence were four times as likely to have engaged in anal sex as those who did not pledge, and pledgers overall were six times as likely to have engaged in oral sex as teens who were virgins but did not take a pledge, the study found. In addition, teens who made virginity pledges were less likely to use condoms during their first sexual experience and were less likely to get tested for STDs, the study found.

Peter Bearman, the chair of Columbia University's Department of Sociology, who co-authored the study with Hannah Bruckner of Yale, told CBSNews.com: "The point is, substantively, that if you knew someone who pledged, and you knew someone who didn't pledge, you had no basis for thinking that one of them would have an STD over the other," said .

"It's a tragedy if we withhold from these kids information about how not to get STDs or not to get pregnant," said Dorothy Mann, executive director of the Family Planning Council, an organization dedicated to reproductive health services.

This is another shot across the bow from the administration to our nation's once-mighty scientific community to serve an ideology. The casualties in the well-documented War on Science include global warming to prevent deadly climate change, stem cell research to prevent debilitating disease, and Plan B pharmaceuticals to prevent abortion even while the FDA Commissioner buys up regulated company stock.

"Our national policies will not be revoked or modified even for scientists. If the dismissal of ... scientists means the annihilation of contemporary ... science, then we shall do without science for a few years."

Adolf Hitler to Max Planck about the exodus of scientists from the country.

YouTube: John Edwards on Climate Change

YouTube - John Edwards on Climate Change here.

John Edwards on Science

Thanks to A Blog Around the Clock, we have an interview with Presidential candidate John Edwards on the science issues we face today, from NASA and climate change to the issues of bio-terrorism.

In honor of LiveEarth, here is his clip of how we should turn climate change into economic opportunity, just as we did during the environmental movement in the 1970s. When the establishment responded to threats against the status quo by stirring up fears of job losses, we learned they were actually discouraging ingenuity and entrepreneurship, stifling innovation in environmental engineering. Now, environmental engineers earn $3.468 billion a year in 2004.

If you like what he has to say below, vote for Edwards's plan here.

Here's more from Edwards:

We need to make certain that America understands this crisis--that if we have a 4 to 8 degree rise in our temperature then there will be migration of hundreds of millions of people. There won't be enough food or enough water and millions of people will be flooded out of their homes. America must understand it and the president of the United States must understand it.

Here's what's really important to understand: we can actually turn the crisis of global warming into an opportunity. We can create a new, clean energy economy that creates 1 million new jobs, ends our dependence on foreign oil, and brings rural communities back to life. And ultimately, we can become a leader for the rest of the
world.

Our first priority is capping and reducing greenhouse gas pollution. We must do what the consensus of the scientific community says is necessary to stop the Earth from getting more than 2 degrees warmer.

What the Bush administration has done is constantly rewrite what the science says and substitute the talking points of the oil industry. They literally hire lobbyists
into the White House to substitute special interests for science. That's got to stop.
What the scientific community says today is - taking into account what's going on in the developing world --- the U.S. needs to reduce our global greenhouse emissions by 80 percent by the year 2050. As president, I will enact a national cap on carbon emissions that meets that goal.

In terms of how we get there, we need to invest in renewable energies like wind, solar, and biofuels. And we have to raise the fuel-efficiency standards significantly in
this country. I believe the number is 40 miles per gallon by 2016. That would single-handedly reduce oil demand by 4 million barrels per day.

We must lead the world to a new climate treaty that commits other countries--including developing nations--to reduce their pollution. I will insist that developing
countries join us in this effort, by offering to share new clean energy technology and, if necessary, using trade agreements to require binding greenhouse reductions.
I will create a New Energy Economy Fund by auctioning off greenhouse pollution permits and repealing subsidies for big oil companies.

The fund will support U.S. research and development in energy technology, help entrepreneurs start new businesses, invest in new carbon-capture and efficient automobile technology and help Americans conserve energy. Finally, we must reduce the demand for more electricity through efficiency for the next decade,
instead of producing more electricity.

Our generation must be the one that says, "We must halt global warming." If we don't act now, it will be too late. Our generation must be the one that says "yes" to renewable fuels and ends forever our dependence on foreign oil. Our generation must be the one that accepts responsibility for conserving natural resources and demands the tools to do it. And our generation must be the one that builds the New Energy Economy. How do we do it? It won't be easy, but it is time to ask the American people to be patriotic about something other than war.

Republicans raise their hands against science

At the Republican debate, three Senators running for President, Brownback, Huckabee, and Tancredo, raised their hands to signify they don't believe in evolution.

Next, they raise their hands to show they don't believe in gravity. Can they still keep their hands up?

Hmmmmm... why not?

They say evolution is "only a theory." However, in science, a theory is more than a "hunch." A theory is a substantiated hypothesis.

A theory is a logically self-consistent model or framework for describing the behavior of a related set of natural or social phenomena. It originates from and/or is supported by experimental evidence (see scientific method). In this sense, a theory is a systematic and formalized expression of all previous observations that is predictive, logical and testable. In principle, scientific theories are always tentative, and subject to corrections or inclusion in a yet wider theory. Commonly, a large number of more specific hypotheses may be logically bound together by just one or two theories. As a general rule for use of the term, theories tend to deal with much broader sets of universals than do hypotheses, which ordinarily deal with much more specific sets of phenomena or specific applications of a theory.

How do these men demand - and get - respect for espousing a belief that is completely unsupported by evidence? Even more, how about for a belief that requires ignoring and denying evidence?

A hysterical commentary on the race to ignorance is here.

"Evolution is a hoax," began Brownback. "It is hubris of the highest degree for scientists to think they know more than God."

"You're right," continued Huckabee, "But let me add that I believe gravity and electricity are also demonic ideas intended to blind humans to the glory of the Almighty."

Tancredo added his voice. "So true, gentlemen. We have lost our way, and I for one, yearn for that bygone era when religion was respected and permeated every aspect of society. I'm not talking about the 1950s. I'm talking about the 1050s. The Middle Ages, when the natural order of society was in balance."