Wednesday, October 15, 2008

Heroes and False Prophets of Vaccine Safety

Congressman Henry Waxman “is a hero on this debate.”

That sentiment has frequently been expressed by liberal-leaning organizations on a wide range of issues during Waxman’s long 34-year career in Congress.

The current praise comes, however, from a more unlikely source: the top pharmaceutical policy expert at the American Enterprise Institute. The issue: upholding the public’s confidence in childhood vaccinations in light of a purported (and still unproven) link to autism.

The California Democrat got that ringing endorsement on Oct. 10 from Jack Calfee, who typically addresses health care issues from a position almost diametrically opposed to Waxman. From the AEI perspective, Waxman is often the epitome of too much government regulation and too much the friend of liability lawyers.

But on vaccine safety, the representatives of two ideologies find themselves aligned. The confluence of views on vaccine safety between AEI and Waxman should bode well for a continued climate of support for vaccines from the federal government, but challenges still persist.

The chief challenge is the continuing political appeal of the groups seeking to link autism to vaccinations.

Calfee’s praise for Waxman came during a question and answer session at an October 10 AEI session on a new book on the science and politics of autism by Paul Offit, the chief of the vaccine education division at Children’s Hospital of Philadelphia.

Offit’s book, “Autism’s False Prophets,” recounts how the proponents of a link between childhood vaccines and autism have pressed the issue into common parlance. The book traces the origins and issues raised from the decade-old effort to describe a link.

Offit, who bravely accepts the challenge to counter the attempt to tie autism to vaccines, notes that there has been a long history stretching back over 200 years of people looking at vaccines as the source of diseases arising from unknown causes. “Vaccines have been blamed for many diseases for which there are no clear causes,” he told AEI, citing multiple sclerosis, epilepsy, diabetes and mental retardation.

“Autism, like those disorders, has no clear cause or cure.” In that context, Offit observes, “it was just a matter of time” until a link to autism was suggested.

During the AEI event, Stephen Cha, an aide to Waxman, noted that the congressman has also taken a public stand to keep attention focused on the weight of scientific studies refuting the link between autism and vaccines.

Waxman recently sent a summary of the major studies to other members of Congress recently to counter arguments at a briefing on autism sponsored by Rep. Carolyn Maloney (D-NY).

Maloney, a liberal Democrat from Manhattan, is the sponsor of a bill (HR 2832) to require the National Institutes of Health to conduct a comparative study of vaccinated and non-vaccinated populations as a way to examine the allegations of a link between thimerosol and autism.

According to blog reports, the Maloney hearing drew representatives from 59 House offices and 30 Senate offices, including Barack Obama’s office.

The high attendance at the Maloney event demonstrates the persistent political attention to the issue. It even raised its head during the presidential campaign earlier in the spring, pushing Obama, John McCain, and even traditional supporters of vaccines like Hillary Clinton to speak out for caution.

Offit suggests that some of the skepticism about vaccine safety arises ironically from well-intentioned but maladroit efforts to reassure the public.

Offit’s account of the problems generated for vaccines by responding to safety questions too rapidly holds a lesson and warning for other segments of the drug industry and for drug regulators as they head further into the age of post-marketing surveillance reports from a wide variety of sources.

“The precipitous and frightening removal” of thimerosol from vaccines for young children rapidly within three years of the first charges of danger from the preservative actually fed concerns about vaccine safety, Offit told AEI. The effort to get the ingredient out rapidly was led by the American Academy of Pediatrics and “to a lesser extent” by the Centers for Disease Control & Prevention.

By handling the removal “in the manner that it was done,” it scared parents, Offit maintains. Because of the rush parents reasonably “would ask why would one take this ethyl-mercury containing preservative out of vaccines in such a precipitous manner if it wasn’t harmful.”

Offit notes that the “American Academy of Pediatrics put themselves in a position to try to communicate something that was virtually impossible to communicate: ‘yes we are taking it out, but there is not a problem.’”

The academy was put in the awkward position of trying to explain why it had urged action if it felt that vaccines were safe. “If you look at the way that they describe” the push to get thimerosol removed, Offit said, “they say that there is no evidence that thimerosol-containing vaccines are harmful, but to make safe vaccines even safer we’re going to take it out.”

“If it had not been shown to be harmful, how does taking it out make it any safer?,” Offit asks. “It doesn’t; it only makes it perceived to be safer.”

If there is a lesson from the autism debate, the right responses to safety concerns for vaccines (and drugs) in the future are going to take fortitude, careful judgment—and more heroes.

Erik Tomas' Raceline Radio Network Newsletter... Oct. 15, 2008

From Erik Tomas, Raceline Radio (www.raceline.ca)

Wow.

Last time I spoke with Helio Castroneves, he had just had his IRL win at Belle Isles Detroit taken away and handed to Justin Wilson because Helio was charged with blocking.

The likeable Brazilian, with a bright and enthusiastic personality, has been charged again… with something a LOT more serious.

And if he’s found guilty, he could serve jail time. He might even be deported!

Castroneves has been charged with 6 counts of tax evasion on 5.5 million dollars in income the Internal Revenue Service claims went unreported between 1999 and 2004.

Helio was led into a Miami Florida court room crying. They had him in handcuffs and leg chains. Seems a little severe considering that’s the same way murderers are fettered, and Helio is not a flight risk.

He entered a plea of not guilty to these very serious allegations. How serious? Bail was set at 10 million dollars, 10 million! It was posted and Castroneves was released after he surrendered his passport and was ordered not to leave the United States.

He told reporters he will “win this race too!”. He then left for Road Atlanta where he and his Penske IRL team mate Ryan Briscoe won the LMP-2 division in the 10 hour endurance race, so this tax mess obviously didn’t mount a huge distraction.

For now.

Helio’s sister Katiucia, his business manager has also been cited in the indictment, as has his lawyer/agent Alan R. Miller. They did not enter pleas and were released on bail.

The Miller angle presents a potential opener of a huge can of worms, as the attorney also represents other drivers including NASCAR Sprint Cup star and 2-time defending champ Jimmie Johnson. J.J says he’s shocked at the charges, saying Miller’s been his lawyer since he was 15 years old, and will sit tight to see how it all plays out.

You have to think “IF” Miller’s in trouble in connection with Castroneves, might his other clients be under IRS scrutiny? It’s logical thought, but not every client employs the same services. I know of one Canadian driver who has Miller do some of his contract work, but nothing to do with his tax prep.

Miller says he’s done nothing wrong.

The tax evasion case is just the tip of the iceberg for Castroneves, even thought it’s an iceberg big enough to sink a dozen Titanic’s!

He can’t leave the States since his passport’s been seized. That means he can’t race for Team Penske at the non-points IRL show in Australia later this month, unless he’s given special consideration.

It will mean Penske will likely have to find a replacement. Roger could look to swing Sam Hornish from his NASCAR arm back to the IRL for now, but a better choice would be our own Paul Tracy. He’s a former Penske pilot and he’s won Oz before.

That may be a permanent adjustment, since Castroneves’ future with Penske is certainly in question, even though the team officially has taken an “innocent until proven guilty” stance. It’s a known fact Roger Penske likes a squeaky-clean image for his charges.

I wondered about this “innocent until proven guilty” stuff. My Dad worked for Revenue Canada for 25 years. He did farm audits. He would often remind us that in tax evasion cases, unlike most legal cases, the government is right until proven wrong. In other words when you are charged, you are guilty until YOU prove the government’s wrong.

Helio catches a break here because the U.S Constitution guarantees a man is innocent until proven guilty, but most lawyers will tell you once The IRS brings charges, it’s pretty much a done deal.

It means Helio Castroneves, who was on top of the world when he won those back-to-back Indy 500’s and that “Dancing with the Stars” thing on TV, is in for the fight of his life to not only stay out of jail, but to remain in the United States to continue his IndyCar career.

I like Helio a great deal. He’s a great guy, and a wonderful personality.

I only hope he’s innocent of these charges, and perhaps was the victim of bad advice.

But the IRS won’t care if you got bad advice. All they know is millions of dollars were made and they charge there are millions of dollars in tax still owing on the income.

If found guilty, Castroneves will have to pay the tax plus interest, pay a huge fine, and very possibly, serve jail time.

No, you’re right…..it doesn’t look good.

And it might not stop with Castroneves.

Wow.

Next week, the FIA power play that threatens to cancel the Formula One Canadian Grand Prix, after the story has a week to simmer.

ET

Council of State Races

Treasurer:

Janet Cowell 44
Bill Daughtridge 41

I have heard that Daughtridge is on television and Cowell is not- I guess I don't watch the right channels to see his ads. If true that would be a continuation of Cowell's disciplined campaigning in the primary where she held back on spending her money toward the tail end even as David Young went on the air earlier and saw his poll numbers improve. Given that Cowell is leading at this point anyway it seems she should be in good shape.

Insurance Commissioner:

Wayne Goodwin 43
John Odom 33
Mark McMains 10

Goodwin is starting to really pull away here.

Labor Commissioner:

Cherie Berry 45
Mary Fant Donnan 41

This is an improvement for Berry from last month although I'm not aware of either candidate really spending any money. Could just be statistical noise.

Full results here.

NASCAR TRUCKS: Martinsville marks Truck Series debut for TRG development driver Ben Stancill (plus JR Fitzpatrick mention)

Mooresville, N.C. (October 15, 2008) -   TRG Motorsports development driver Ben Stancill will add another chapter to his developing career when he makes his NASCAR Craftsman Truck Series debut on Saturday at Martinsville (Va.) Speedway.  The 19 year-old driver will be making his first career NCTS start in the No. 71 Zero Seconds / “Get Well Grace” Chevrolet, after two previous and successful starts for TRG Motorsports in the ARCA RE/MAX Series which resulted in seventh and 12th place finishes.

The Ayden, North Carolina native will be competing in one of three Chevrolet’s fielded by TRG Motorsports at the 0.526-mile oval.  Stancill and his teammates - T.J. Bell and J.R. Fitzpatrick - will negotiate the tight half-mile Virginia short-track in a rare three truck effort by TRG.   TRG Motorsports’ Team Principal, Kevin Buckler, commented on bringing Stancill up through the ranks.  “We are truly excited to be a part of Ben’s ascension through the NASCAR ranks,” said Buckler.  “This boy has talent.  This will be his first Truck Series race and we will be working hard to give him a great truck, great team and a strong finish.  This is all part of the bigger picture though, we are trying to prepare him for a full season next year so we need to be a little careful but then again - this is Martinsville and it's going to be a real street fight.  This is going to be good and we have a ton of confidence in his abilities.” 

While Stancill is new to the NASCAR Craftsman Truck Series and Martinsville Speedway, he is very excited about the track because it fits his style of racing.   “I am excited about competing with TRG in the NASCAR Craftsman Truck Series and I think Martinsville is one of the most exciting races on the circuit,” he explained.  “The racing that goes on at Martinsville fits comfortably with my short track experience and is a great place to catch up with many of my fans.   I have a strong fan base in the Virginia area and every time we visit these tracks we see many of the same faces.   It has a great stock car racing heritage, and I owe a lot of gratitude to these fans.   I am sure we will put on a great show.”

This race will also give Stancill the opportunity to send several messages.  The hood of his No. 71 Chevrolet will feature the Zero Seconds campaign and the rear quarter panels will be a tribute to Stancill’s childhood friend Grace who is living with Guillain-BarrĂ© Syndrome.  Grace was a classmate of his from kindergarten through high school.   While attending Mt. Olive College in North Carolina, Grace was stricken with this rare disorder which affects the body's immune system, attacking part of the peripheral nervous system.   While there is no known cure for the disease, therapy can lessen the severity of the illness and accelerate the recovery in most patients.   Stancill’s wish is that his simple 700 horse power “Greeting Card on Wheels” can assist in motivating a speedy recovery for Grace.

Stancill will roll out his “Greeting Card on Wheels” when the Series hits Martinsville Speedway on Saturday, October 18th for the Kroger 200.  Live television coverage will be provided by the SPEED Channel at 2:30 p.m. ET with radio coverage coming to you live courtesy of MRN Radio.

From Jamie Maynard / TRG

Governor's race still close as can be

Bev Perdue 45
Pat McCrory 44
Michael Munger 4

Not a whole let new to say here. The candidates have been within three points of each other every time we've polled this race since Labor Day.

Some people think independents are helping McCrory stay in this race, and while they do support him by a 41-37 margin, the bigger issue for Perdue is that she's losing too many voters from her own party. While McCrory has the support of 82% of Republican voters, Perdue's only at 74% with folks in her party. If she brings that closer to 80% she'll probably win.

Perdue is doing a good job of lining up the black vote- she is now polling at 82% with them. But McCrory is winning a full quarter of the white Democratic vote.

Perdue would also be in better shape if she was as popular with young voters as running mates Barack Obama and Kay Hagan. Each of them have a 30+ point lead with voters under 30, while Perdue is only up 11 with them. If she can get more of trickle down from the top of the ticket her standing will improve.

This one seems likely to be close to the end.

Full results here.

Tire shopping made easy for Canada’s Nissan and Infiniti owners

LANGLEY, B.C. (October 15, 2008) – Replacing their original equipment tires just got easier for the owners of Nissan and Infiniti cars and SUVs thanks to an agreement between Nissan Canada Inc. and Yokohama Tires (Canada) Inc.

The full line of premium Yokohama tires, including an updated line of state-of-the-art winter tires, will be available through Canada’s 180 Nissan and Infiniti dealers, effective immediately. The agreement gives Nissan and Infiniti owners convenient access to the right tires for their vehicles with the added confidence of dealing with their favourite dealer.

“This agreement not only helps Nissan and Infiniti dealers maintain their good service relationships with their customers, it helps expand Yokohama’s retail presence without compromising our existing tire dealer network,” explained Eric Dedoyard, Director of Sales for Yokohama Canada. The dealerships will work with existing Yokohama dealers to manage product distribution.

The broad Yokohama product range is ideally suited to the extensive line of Nissan and Infiniti models that ranges from efficient sub-compacts to capable family cars and SUVs, and includes premium sedans and high performance sports coupes, said Dedoyard.

Yokohama Tire (Canada) Inc. markets and distributes a full line of tires for high performance, passenger car, light truck, and commercial truck applications, as well as off-the-road tires for mining, forestry and construction applications. It maintains distribution centres across Canada to serve more than 700 independent tire dealers.

Internet Safety for Children

With the internet being such a vast tool today, it's easy for kids to get into mischief there-- whether they know it or not. Attorney General Tom Corbett's office presented an internet safety program at the Children's Museum of Pittsburgh that over 100 local school children attended. Child Watch of Pittsburgh Executive Director Amy Raslevich said the attorney general listed three ways for kids to be safe, including: not posting information like a full name and address with pictures, staying away from profiling Web sites such as Myspace.com and chatrooms, and telling a parent or adult if they find something that looks suspicious.

Parents can also help by closely monitoring their children when they use the internet and tell them what is appropriate and what isn't.

World Leadership Conference in Pittsburgh

The International Women's Forum (IWF) is holding its annual World Leadership Conference in Pittsburgh. Leaders from more than 60 different countries are meeting to talk about sustainable cities and how to attain them. Attendees will pay careful attention to Masdar City in the United Arab Emirates, which is being built to be the world's first "zero-carbon, zero-waste, car-free city."

IWF President Esther Silver-Parker says the conferences are always focused on developing more women leaders, and on how women can become involved in worldly situations.

They have previously met in places like Seattle and Buenos Aires, Argentina. They plan to meet in Hong Kong in the spring.

Michelle Obama coming to Pittsburgh

The Wife of Democratic presidential nominee Barack Obama will rally voters in Oakland Thursday. Michelle Obama will host a “Change We Need” rally at Soldiers and Sailors Memorial. Doors open at 10:30. The campaign says the event is free and open to the public but reservations are recommended. Michelle Obama is expected to talk about, “The issues at stake in this year’s election” and “The challenges of everyday Americans.”

BNY Mellon Gets Contract to Administer Bailout Funds

BNY Mellon will not be making any decisions on how the funds will be spent and invested but it will hold all of the cash, assets and securities for the Treasury Department. The company will eventually run the auctions for the assets. BNY Mellon was one of 70 financial institutions to submit a bid to manage the fund. The three-year contract to administer the funds can be renewed on a year-by-year basis each of the 4 years following the initial contract. Also announced yesterday was the investment of $3Billion of the $700 Billion bailout fund in BNY Mellon preferred stock. It was one of 9 banks the feds invested in Tuesday. None were deemed to be in distress. BNY Mellon spokesperson Ron Gruendl says the purchase of the stock will not have any impact on the management of the company and it will also not dilute the dividends that will be announced Thursday. Gruendl says it is unclear how the contract will impact the Pittsburgh workforce.

Where have all the PUMA's gone?

The following report is also available in PDF form on our main website:

There was a lot of bluster from certain supporters of Hillary Clinton, particularly in the days soon after Barack Obama became the presumptive nominee, that a huge chunk of Democratic voters would vote Republican or stay at home this fall. A lot of summer polling backed up their point, and showed a significant unity gap between Democratic and Republican voters.

In our final pre-convention polls of seven battleground states John McCain was winning 87% of the vote from self identified Republicans while Barack Obama was getting just 78% from Democrats. On average McCain’s lead with voters of his own party was 14 points greater than Obama, and the discrepancy was particularly remarkable in Florida, Missouri, North Carolina, and Ohio. At that point McCain was winning in three of these states, losing in three of them, and tied in the seventh.

State

Democrats

Republicans

Difference

Colorado

Obama 85-11

McCain 84-11

D+1

Florida

Obama 76-16

McCain 84-12

R+12

Michigan

Obama 84-8

McCain 87-9

R+2

Missouri

Obama 78-15

McCain 92-7

R+22

North Carolina

Obama 69-19

McCain 86-6

R+30

Ohio

Obama 75-17

McCain 89-7

R+24

Virginia

Obama 84-12

McCain 89-8

R+9

Average

Obama 78-14

McCain 87-9

R+14

Current polling data, however, indicates that any PUMA effect that may have been present in summer polling is long gone in the post-convention period:

State

Democrats

Republicans

Difference

Colorado

Obama 89-7

McCain 85-10

D+7

Florida

Obama 81-15

McCain 84-11

R+7

Michigan

Obama 89-6

McCain 85-11

D+9

Missouri

Obama 89-7

McCain 92-7

R+3

North Carolina

Obama 79-18

McCain 89-7

R+21

Ohio

Obama 84-9

McCain 89-8

R+6

Virginia

Obama 91-6

McCain 89-8

D+4

Average

Obama 86-10

McCain 88-9

R+3

Now there is just a three point gap between the level of support McCain is getting from Republicans and that Obama is getting from Democrats. Obama has increased his average support within the party by 12% over the last two months while McCain has gained just a single point with voters in his.

One thing these numbers speak to is why Sarah Palin was such a poor choice of running mate for John McCain. For all the claims that she has motivated the Republican base the reality is that, enthusiastic about him or not, Republicans were already unified behind McCain before the convention. They would have come out to vote for him anyway out of dislike for Obama, and their unenthusiastic votes would have counted just the same as their enthusiastic ones.

He didn’t need to make a choice to mollify conservatives in the party who are less than enamored with him. Rather he needed to win over independents and conservative Democrats. But our polling has shown over and over again that Democratic voters really don’t like Palin, and that is particularly true with female voters who might have originally supported Hillary Clinton. The Palin pick has helped to unify support for Barack Obama among folks in his party.

Other factors helping lead to this increased party unity have been the downturn in the economy, helping to focus Democratic voters on the need for their party to be in power to deal with these issues, and the more enthusiastic support for Obama among Bill and Hillary Clinton.

Whatever the reason for the increased unity, there isn’t much doubt what its effect on the race has been:

State

Pre-Convention Poll

Most Recent Poll

Shift

Colorado

Obama +4

Obama +10

Obama +6

Florida

McCain +3

Obama +3

Obama +6

Michigan

Obama +3

Obama +10

Obama +7

Missouri

McCain +10

Obama +2

Obama +12

North Carolina

McCain +3

Obama +3

Obama +6

Ohio

Tie

Obama +6

Obama +6

Virginia

Obama +2

Obama +8

Obama +6

Average

McCain +1

Obama +6

Obama +7

Obama’s average gain across the board is seven points, with the shifts remarkably consistent: six point gains in five states, one seven point gain, and one twelve point gain.

The PUMA effect provided for an interesting media narrative during parts of the summer, but it doesn’t appear likely to end up having a real impact on the election.

Tuesday, October 14, 2008

West Virginia

I know you all want West Virginia, and frankly we do too.

If someone can get me a random sample of people who voted in the 2004 general election, 2006 general election, or 2008 primary in West Virginia then we will poll it. Concern about being able to get a sample of sufficient quality there is what makes us, and I'm guessing other companies that do registration based sampling, hesitant to poll there. That's not a problem with most other states.

1-mile, 65,000 seat speedway announced for Fort Erie, Ontario

PRESS RELEASE

An investment consortium led by Kuwaiti Islamic investment bank Bayt Al Mal Investments will bring a major motor-sport, entertainment and commercial complex to the Niagara region of Ontario and with it, additional foreign direct investment (FDI), jobs and tourists from across the US-Canadian border.

"This is an outstanding example of how FDI supports growth in Ontario," Bayt Al Mal did their homework, recognized Ontario's tremendous potential and made a wise decision to invest here. This investment is only the beginning and will help to widen the investment corridor between the Middle East and Ontario," said The Honorable Sandra Pupatello Minister for International Trade and Investment, Ontario, Canada.

Bayt Al Mal has seized a first-mover advantage in Ontario, and we certainly consider them a leader in this respect. On our part we are committed to providing the necessary support to help make this initiative a success," she added.

Peter Partington, Regional Chairman for Niagara, underscored the substantial economic impact of the investment.

"This project will generate over C$34 million per year in new tax revenue alone and create over 1,200 jobs. The region will receive a huge shot-in-the-arm through increased economic development and tourism."

Looking ahead Shams Faiz, Chief Operating Officer at Bayt Al Mal Investments stated, "Our aim is to be a GCC-Canada investment specialist and we will soon be announcing our 'Invest Canada' program that will open a number of well studied investment projects for our regional investors."

Bayt Al Mal has already acquired 623 acres of land in Fort Erie, six kilometers from the US-Canadian border, where this master-planned complex will be built.

"This is a strategic location giving us access to a motor-sport fan base of over 120 million people," said Faiz,

"This is a vanguard project being the first GCC investment of this magnitude in Canada which also gives Bayt Al Mal a market-leading edge. Having successfully secured this transaction, we are now exploring other potential business opportunities in Canada." said Suleiman AlQimlas Chairman Bayt AlMal Investment.

"We have invested significant capital and management resources in Canada and have developed major alliances that will provide our investors with a unique advantage in accessing high quality high return investment opportunities there. We have local presence in Canada through our subsidiary Emirates Consulting, which oversees our investor interest and helps us in developing proprietary transactions and business relationships," added Faiz.

"We have been working closely with Bayt Al Mal for the past 18 months", stated Mayor of Fort Erie, Douglas Martin whose city will host the complex. "This agreement has generated great excitement and anticipation amongst my regional colleagues and my fellow Mayors of Niagara Falls, St. Catherines, Welland, and Port Colborne."

FACT FILE:

Bayt Al Mal has purchased 623 acres of land in Fort Erie, six kms from the U.S. border.

It would hire 1,200 people to construct the facility, and 120 full time employees to run the ongoing operation

Currently, over seven engineering firms with 45 Ontario based engineers and consultants have been engaged by the project.

Initially a 65,000 seat facility, expandable to 100,000, will encompass a 1 mile oval track and 2.5 mile road course essential to the broader economy.

Bayt Al Mal's local partner managing the Fort Erie initiative is Toronto-based Emirates Consulting.

The full release appears here.

UPDATE: The Buffalo News' story is here. Niagara This Week has a piece here.

Where should we poll next week?

This democracy thing worked out last week so let's try it again. Seven choices on where we can poll next week:

-Arizona. With Hispanic voters in the region unifying around Barack Obama, it could be at a surprising level of competitiveness. A refresh of how Janet Napolitano and John McCain might face off in 2010 would also be interesting.

-Georgia. This is one of three states I'm offering up as possibilities because their large black populations could make them surprisingly competitive if whites and blacks turn out at similar rates and Obama can pull off enough of the white vote. And of course the Senate race has become very tight.

-Indiana. I don't think any explanation is really needed.

-Michigan. That's what we would regularly be polling this week but it seems less pressing with McCain pulling out of the state. I like polling it because it's where I come from but beyond that...

-Mississippi. Similar to Georgia, and also with a compelling but under polled Senate race.

-Nevada. I'm sure this is firmly in the Obama column at this point but there still hasn't been that much polling confirming it.

-South Carolina. Similar to Mississippi and Georgia. When we polled it in July Obama was only down by six. Plus I'm curious to see how Stephen Colbert would stack up against Jim DeMint in 2010.

Personally I'm voting for South Carolina- but the majority will rule. Poll is at the top of the page and I'll keep it going until around 4 PM Thursday.

Missouri: Other Offices

As Barack Obama's standing in Missouri has improved, so has that of most other Democrats running for statewide office in the state.

Jay Nixon leads Kenny Hulshof 52-39 for Governor, up from 48-42 when we polled it in August.

Sam Page is making the race for Lieutenant Governor competitive. The challenger trailed Republican incumbent Peter Kinder 48-37, now it's just 47-44.

Robin Carnahan was a cinch for reelection as Secretary of State then, and she still is now. Her lead has increased from 49-39 to 54-39.

The race for Treasurer appears to be extremely close. Democrat Clint Zweifel is now up 42-41 after trailing Brad Lager 41-36 during the summer.

The margin in the contest for Attorney General has seen the least change. Democrat Chris Koster now leads 45-41, just a slight up tick from his previous 42-39 lead.

Full results here.

Obama takes a small lead in Missouri

Barack Obama 48
John McCain 46

Barack Obama has taken a small lead in Missouri after trailing by ten there in PPP's most recent previous poll of the state, conducted in late August.

A big trend between the two polls is increased Democratic unity in the state. Over the summer Obama was winning just 78-15 among voters in his own party. That's now up to 89-7. Obama has also cut down significantly on John McCain's margin with white voters. What was a 56-35 lead for the Republican with that group is now down to 52-42.

As it is in every state the economy appears to be a key factor in Obama's Missouri success. 63% of voters list it as their top concern, and among them he leads 57-38.

Part of what's making this state a tossup after it went for Bush in 2004 is shifts in suburbia. The 2004 exit poll showed the Republican winning 52-48 in the suburbs, but Obama currently has a 55-40 lead there.

Full results here.

Taxpayer Assistance Forum Tomorrow

A forum tomorrow is aimed at helping Allegheny County residents who are having trouble paying their real estate taxes or mortgages. The county's Treasurer, Controller and Sheriff will all attend. Controller Mark Patrick Flaherty says they want to hear suggestions about what the county can do to help residents who are having problems with taxes or foreclosures. So far, the county has delayed its annual filing of real estate tax liens. Normally, they're filed in August. A new date has not been set. A Taxpayer Task Force is also studying ways the county can help taxpayers.

The forum will be held in the Allegheny County Courthouse's Gold Room tomorrow from 5 to 7 pm.

Rick Young's 'Rick at the Races' Oct. 11/12, 2008

PIC 1     Miss Motorsports poses by Brett Hearn's car
PIC 2     Pete Bicknell makes an exit from the 358 race
PIC 3     Billy Decker wins the 358 race
PIC 4      Jeff Rudalavage at Five Mile Point
PIC 5      Alan Brown and 'yours truly' at Five Mile Point
PIC 6    Five Mile Point Feature winner Mike Colsten
PIC 7     Giles Godard at Syracuse
PIC 8     The # 4 Pro Stock of Roch Aubin at Syracuse
PIC 9    Joey Ladouceur recieves at cheque at Syracuse
PIC 10   Sean Corr wins the Pro Stock race at Syracuse
PIC 11   Stuart Friesen prior to the RITE AID 200
PIC 12   'yours truly' with Dale Planck prior to the RITE AID 200
PIC 13   Frank Cozze wins the big one.

You can see more of Rick Young's work at: www.rickattheraces.com
 
Due to work commitments I had to wait a couple of days before I could return SUPER DIRT WEEK at Syracuse following my visit to the 'Happy Hour' this past Wednesday. That meant I had to miss the two 358 'satellite' events at Brewerton (Thurs) and Rolling Wheels (Fri) , that went ahead free from weather related problems , unlike the Can Am show on Wednesday that got rained out.

I left my place at Long Sault at 5-15 on Saturday morning and met up with my buddy, Jim Clarke for breakfast at 8-00 am at the Grist Mill , in Parish NY on the I 81. From there we drove down to Syracuse.

By 9-00 am on Saturday morning (Oct 11) we were parked up at the Fairgrounds for the first of the two headline events of the weekend.

With all the diabolical weather we've experienced this year, where rain has caused so many issues, I was fearing the worst for Syracuse, but just like Wednesday, it was warm and sunny. It was a beautiful day and the forecast was good for the rest of the weekend.

It was warm enough for T shirts and I'm sure that Miss Motorsports Tiffany Skias was a 'happy camper' for her traditional Saturday lunchtime bikini 'photo shoot' at the AARN booth.

Everything went well, and it wasn't long before Billy Decker was celebrating his victory in the 358 'Salute to the Troops' 150 lapper (around 5-00pm). Top Canadian, and past winner Pete Bicknell of St Catherines (Ont) was an early casualty after a first lap incident.

I decided to give the Sportsman race and the 'satellite' events at Rolling Wheels ( Sprint Cars) and Weedsport ( the last chance Modified qualifier) a miss and took off in a southerly direction to Binghampton. The non-DIRTCAR sanctioned track of Five Mile Point were running a “Southern Tier' 50 lap Modified race that night and this was a track I hadn't been to before. Most years when based in Syracuse I try to do something 'different from the rest' on the Saturday night.

I arrived at Five Mile Point a bit late as I had difficulty finding a room for the night, but got there in good time for the feature. Prior to the race they had an on-track 'meet the drivers' session where I was able to take some close up photos. While doing this I met up with Jeff Rudalavage # 112. A couple of years ago I was taking photos of Jeff on a regular basis, when he was a team owner and Alan Johnson was driving his car. I remember having a beer and a chat with him in the Lebanon Valley Speedway bar that year.

The next familiar face I bumped into was Allan Brown from Comstock Park , Michigan. Allan is a fellow 'Trackchaser' and publisher of the National Speedway Directory , the 'must have' , book for all race fans. He presented me with a complimentary 2008 copy in recognition for one of my photos used on the cover ( Pat O'Brien and Danny Johnson side by side at Can Am). I sat with Allan and his friend Freddy Pearson to take in the action.

I really enjoyed what I saw, and the racing was first class. There was a great four way battle for most of the race involving Mike Colsten, Joey Grammes ,Tony Kawalchuk and Rudalavage . It was Mike Colsten who was at the front when it mattered. After the races I walked round the pits with Freddy and he introduced me to Joey and Tony.

FIVE MILE POINT became # 172 on my TRACKCHASING Totals

After staying overnight in Binghampton, I drove the one hour and thirty minutes back to Syracuse in the morning. Again the sun was shining and for the second day running I was wearing a T shirt. Today was the big one, the RITE AID 200 ( formerly the Eckerd 200) for Big Block Modifieds and the place was packed with eager DIRT fans.

As always the support race was a 25 lapper for DIRT ProStocks. My buddy Joey Ladouceur who was on the front row told me how he'd blown his engine the day before, during qualifying and an unknown donor had loaned him a replacement motor. There were two other friends of mine from Ontario in the race, Roch Aubin from Alexandria and Giles Godard from Cornwall. Normally the Pro Stock division provide fans with succession of cautions but on this occasion they behaved themselves quite well and the race went reasonably well. Lebanon Valley Speedway regular Sean Corr # 8C won this one.

When the Modifieds took to the track , it was Tim Fuller and Matt Shepherd who led the pack, but in a 200 lapper like this it means nothing, as anything can happen. Once again fuel and pit stop strategy was a key factor and as the laps ticked away many of the main contenders fell by the way side. Frank Cozze # 44 took the lead from Vince Vitale # 56 on lap 124 and with various others in hot pursuit, many people were wondering if he'd got enough fuel. As the white flag came out Cozze , who must have been 'running on fumes' and with Shepherd on his tail managed to power it round the final mile to take the checkers. It was a popular win with the fans, (me included), who've been waiting a long time to see the Wind Gap, Pennsylvania driver get the big one. Both Canadian drivers, David Hebert and Stuart Friesen put up great performances and were never too far from the front.





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Nearing an End to the Longest Review?

Ovation reached a milestone this month in its quest to get its GABA-transaminase inhibitor vigabatrin (Sabril) on the market: It received confirmation from the Food & Drug Administration of a tentative date for an advisory committee meeting.

Given that FDA has held 30 advisory committee meetings so far this year, that doesn’t sound like groundbreaking news. But in the case of Sabril, it’s a major development given the difficulty FDA has had in finding enough qualified advisory committee members under the new conflict of interest guidelines.

We wrote about Sabril as a worst-case example of the approval delays in the new user fee era in last month's issue of The RPM Report. But is also a poster child for what can go wrong under FDA's new conflict of interest guidelines. (We'll have more on that on this blog and in the next issue of The RPM Report.)

But for now, here's the short story: An advisory committee meeting for Sabril was originally scheduled for August, but there was one (tiny) hiccup. It turns out that the only pediatric neurologist on the committee, Dartmouth Medical Centers Greg Holmes, did work on the original NDA when it was owned by Sanofi-Aventis predecessor company Marion Merrell Dow.

That’s a definite no-no under FDA’s new guidelines. Holmes was recused, and it has taken until now for the agency to reschedule the meeting for January 7-8, as reported in this week's issue of "The Pink Sheet." Of course, that’s assuming FDA can find a qualified pediatric neurologist who hasn’t run a clinical trial for vigabatrin (or a competitor), or invested more than $50,000 in Ovation (or a competitor), or is conflicted in some other way.

But perhaps the Greg Holmes snafu is only fitting for a drug like vigabatrin, which has already had an excruciatingly long pathway toward approval.

Vigabatrin was developed in the 1980s by Merrell Dow as an anticonvulsant. Three advisory committee were convened (in 1984, 1985 and 1989) in light of toxicity signals seen in animal models. An NDA finally was submitted in 1994 by Marion Merrell Dow; FDA turned it down twice before it was outlicensed to Ovation in 2004 by Aventis (now Sanofi-Aventis).

Ovation has had much more success with vigabatrin, having moved from the licensing deal to a priority review for a more targeted indication of infantile seizures in three years. (Ovation also is pursuing the original indication for use in complex partial seizures; the company submitted a response to FDA's questions about that application late last year.)

FDA's deadline for a decision on both indications was June 27--more than three months ago. Between the missed user fee deadline and the immense difficulty in finding enough experts to staff an advisory committee, Sabril is the worst-case example of drug regulation today.

Will there be more? Probably. Will it be yours? Stay tuned.

Senate race tightens

Kay Hagan 46
Elizabeth Dole 44
Christopher Cole 5

Elizabeth Dole's been throwing everything but the kitchen sink at Kay Hagan for weeks now, and it finally appears to be having some impact. Hagan's lead in this race is now back within the margin of error for the first time since mid-September.

The movement here is similar to that seen in the Presidential race. Hagan is holding steady with an 11 point lead among independents, but Dole has made some in roads with Democrats, who now report supporting Hagan by a 75-16 margin, down from 79-12 last week. In her first race Dole benefited from a lot of support with conservative Democrats and she'll need to keep a lot of those voters in her camp to win reelection.

The good news for Hagan? Voters who are undecided for Senate overwhelmingly support Barack Obama for President, 50-27. She just needs to make sure they vote the rest of their ballot when they come out to vote Democratic for the top office, and she'll probably win.

One other note here: Libertarian Christopher Cole continues to poll very well in this race even as Bob Barr has become pretty much a complete non-factor. I think it is entirely possible that he will get a decent percentage of the vote, benefiting from folks disgusted with the mudslinging between Hagan and Dole. This will doubtless tempt pundits who don't do their research to declare that Cole is serving as as a spoiler for the Republican Dole, but the reality is that Cole's supporters go 40-36 for Barack Obama for President. Thus it would appear he is most likely taking equally from Hagan and Dole.

Full results here.

Obama maintains small NC lead

Barack Obama 49
John McCain 46
Bob Barr 1

Barack Obama continues to hold a small lead in North Carolina, although it is down from six points last week.

The McCain campaign has just recently started to really contest the race here, with the candidate making his first appearance in the state in five months yesterday. He has also ratcheted up his advertising, which seems to be having a mixed effect on his poll numbers. Independents, who may be turned off by the negativity of his campaign, have moved more toward Obama in the last week. What was a 46-40 lead with them is now a 52-37 advantage for the Democrat.

They may be helping on some fronts though. There has been six points of movement in McCain's direction among Democratic voters since the last poll, with what was an 82-15 advantage for Obama now down to 79-18. Obama's standing in the state had improved with each passing week as more conservative Democrats who sometimes choose Republicans for Preisdent had moved toward his camp. With McCain's campaign now trying even harder than usual to paint Obama as an extremist that may be having the effect of helping to get more of those folks to cross over to the Republican candidate.

Obama's unusually strong standing here continues to be fueled by voters in suburbia. They voted for George W. Bush in 2004 but Obama leads with them 57-39 this time around. That's the fastest growing group of the electorate in North Carolina, and if they continue to lean Democratic the state is going to be competitive at the national level for cycles to come.

Democrats had hoped that Bob Barr might play the role of spoiler here and take enough support away from John McCain that Obama could win the state with just 48 or 49% of the vote, but the Libertarian candidate has pretty much ceased to be a factor here.

The economy is polling as the top issue for a new record high of North Carolina voters: 65%. Obama leads 59-36 with those voters.

Full results here

Lilly/Imclone: Hedging Payor Risk

Imclone’s Erbitux is a quintessential example of a high priced cancer medication of the type routinely cited by advocates for some form of national comparative effectiveness project in the US.

So it may seem odd to argue that Lilly’s decision to step in and buy Imclone away from Bristol reduces the company’s exposure to a potentially tougher pricing climate in the US.

But in one important sense it does: It gives Lilly about $400 million in annual revenues that are sheltered from any impact of the upcoming debate over price negotiation under the Medicare Part D program in the US.

Like most Big Pharma companies, Lilly’s product line is heavily tilted towards the types of products paid for under the new Part D program: chronic, oral medications like Zyprexa and Cymbalta. And, like most Big Pharma’s with mature product lines, that means Lilly has benefited from a de facto price increase, thanks to the transfer of a lot of use of those medicines out of the price-controlled Medicaid market and into the managed care plan-administered Part D program.

And, like most Big Pharma companies, Lilly is concerned that the US government is about to do something about that.

Here is what Lilly SVP-corporate policy and strategy had to say during FDC-Windhover’s Pharmaceutical Strategic Alliances Conference about the potential impact of a price negotiation model in the US.:
“Eliminating the non-interference clause in the Medicare program could have a significant impact….When the government starts to enter into direct negotiation and they pay for the majority of the drug in the county, inevitably the political pressure and budget pressure will end up damaging the ability of the industry to continue to innovate. So I do have a concern, and I’m not sure that the whole of the biotech industry is perceiving that danger. But we, the big large companies that have experience in working in those countries where indeed there are price controls, I think we have a better perception of what that will mean. And in my opinion it might hurt the willingness of investors to continue to put money into research.”
Erbitux, like most infused biologics, is paid for under the Medicare Part B program. Now there are plenty of opportunities for the government to meddle then—but it isn’t on top of the agenda at the moment.

Interestingly, a lot of Big Pharma companies are modeling the impact of government price negotiation under Part D as about a 3%-4% hit in the US. Lilly’s US business is about $10 billion. How nice to have about $400 million in new revenue coming from a product that isn’t touched by price negotiation…

For some background reading on how price negotiation may translate into real price pressure, start here. For more on how companies approach the two different payor models in the US, start here.