Tuesday, July 31, 2007
Patrick Carpentier, (Driver, No. 22 Zellers Dodge Charger)
What are you looking forward to this weekend? “I am looking forward to going back to Montreal. I haven’t raced there in a couple years, but I am really looking forward to driving these cars in the Busch Series let me tell you. Forty-three cars coming into that tight corner one there is going to be a good show for the fans. We tested yesterday a little bit and things went pretty well. We’re really happy and now we’re looking forward to it. I’m really looking forward to go there. I think the guys are going to like the city there.”
How different is racing a stock car compared to some of the other cars you’ve raced? “From the Indy cars it’s a world apart. You’ve got so much downforce in an Indy car that you can’t compare. With the Grand Am I was pleasantly surprised. It’s very close to what I am driving now in the Rolex Series where you sit on the left side. There was a high-speed corner where we went testing yesterday at the track in Kershaw, North Carolina. I was impressed with the speed that these cars can take the fast corners. It’s unbelievable to carry that much weight around with the car and not a lot of downforce. The grip that the car had was unbelievable. For me, I really had a good time yesterday. We didn’t drive too long because it rained most of the day. We only drove like an hour but it was enough to see what the car felt like. Because I have done the Rolex and stuff it feels like a world apart now.”
Are you ready for the bumping and banging that comes with driving stock cars on a road course? “I was in the shop this morning having mirrors inside the car because you see nothing out of these things. Man, how do you know who is inside you and outside you and all of that stuff like that so we kept adding mirrors this morning. I know you have spotters, but I always feel more comfortable when you can see what is on your right side, so we kept doing that this morning. The guys were like, ‘Huh, that is the first time that I’ve seen that with mirrors.’ It’s good.”
Can you talk about the adaptability of race car drivers in general? “I think once you get to a certain level whether it’s a guy that comes from Indy or NASCAR, if you get to the ovals, I’ve done a lot of ovals in different series and the Rolex and CASCAR and this and that, then you end up getting an idea of what any car should pretty much feel like. For me what the concern is that it’s so competitive NASCAR now a days. For a race in Montreal I don’t know if the brakes, how you need to save the brakes because it is a very hard track on the brakes. The tires and stuff like that is my concern. To do a quick lap and stuff like that I think you can do it. Paul Wolfe, who is chief mechanic on the team, yesterday made some changes in the car and we gained over two seconds in one change and then we were right up there with the times that Robby Gordon did at the test last week at the track. I was pretty happy about that but my concern is the race. When you enter the race it’s always a different story. That is when experience comes into play a little bit. There are some guys there that really know their stuff. For me there is always a learning curve and right now I am trying to shorten it as much as I can, but we’ll see how it goes in the race.”
Do you think motorsports champions have common traits and abilities? “I think so. I think if you can see it with Montoya you know. He drove Indy cars, F1 and now with NASCAR. He did pretty well last weekend at The Brickyard. Tony Stewart was in IRL before he went to NASCAR. I think the guys that run fast, and are champions as you’ve called them, whatever series they do whether it’s F1 or anything, if they are in a good car surrounded with a good team they’ll do well in pretty much any kind of circuit. They’ll adapt to the track very quickly. It’s like Montreal, a lot of guys don’t know the track but come Thursday before lunch time everybody will know the track. Everybody will know the little tricks here and there. They’ll have caught up with the guys at the front. It’s guys that really can adapt very quickly that can do any type of car or race track that they are in to if the equipment is good of course.”
What is the response you’ve gotten from the people in Montreal? “It’s been fun. You know what we did for Zellers, one of the sponsors on the car, all last week we did pretty much all of the stores in Quebec trying to bring more attention to the race and bring people into the race. I was amazed. I would say that three quarters of the fans that came in and we signed autographs for, in a few places we signed for like two hours, and we had to stop the line at the end because we had more people coming in. I was amazed because most of the fans coming in were NASCAR fans, not necessarily a Carpentier fan but just NASCAR fans. They were happy that I was getting into the series and that. A lot of people follow NASCAR and I was really impressed with that. NASCAR brings a huge fan base with Montreal and that. I did a few races with Indy cars and stuff. I think if we put it together we’ll have a good crowd. You have guys like Robby Gordon, Carl Edwards and all these guys that are coming to Montreal. They’ll attract a lot of people. The response has been amazingly great.”
Who is the driver that you would most like to beat in the Busch Series? “There is probably going to be like 42 of them that I would really like to beat, (Laughs), in the series. To run in the top 10 or the top five with these guys I would love to but it’s so competitive. I’ll try and run up with these guys and just have a good time with the fans and the people. That is what I want. If I can do that it would be great. You always want to beat the best of them, so we’ll see who runs fast in Montreal. There is nobody in particular that I would like to beat. I would more like to run with the guys, battle with them and have fun and run. Whether you finish the race first, second, third, forth, whatever, or wherever you finish just being able to enjoy it and battle with these guys. That is what I would like.”
Are there some keys to the Montreal track that you think will help you based on your experience there? “Yeah, I thought it was going to help me, but then they went and put a test day on Thursday, so everyone will know the track. Before I knew they were going to put a test day on Thursday I was like, ‘Oh, this is good nobody will know the track and we will only have a couple practices.’ Now with the test on Thursday I think it is going to be pretty much a level playing field.”
You’ve raced some of the other open wheel folks before. What are your thoughts on them? “I am still racing them. They are all in the Rolex Series now. The prototype series. The Grand Am. I am going to race that on Friday also. I have raced a lot of guys. There is Michael Valiante that is going to be there. I don’t know if it’s finalized yet or not, but all these guys and Robby Gordon, who I raced in CART at the time. It’s quite a few guys. It’ll be good to talk with them and race with them again in a different kind of car.”
Do you ever see yourself running in the NEXTEL Cup Series? “I would love to. For me what I love the most is hopefully with the sponsors with Zellers and Dodge, hopefully we get a good race, a good showing and they love the crowd reaction and what’s happening there. Hopefully that puts us into the Busch Series. I think I need to do a few races and a few runs in the Busch Series just to learn the do’s and don’t’s of how the guys race on an oval and a road circuit. We’re already talking I might be back in a Busch car on an oval this year, so it’s looking a little bit better.”
Did any of the NASCAR fans that you’ve met say that they have ever attended a NASCAR race? “Yes, Watkins Glen and New Hampshire. A lot of guys have been to quite a few races. The most popular one that I saw, because there are a lot of people that go from Canada to Florida, is Daytona. A lot of people went to a Daytona race. They have their seats reserved there and they go every year. That is the one that I heard the most.”
Do you expect a lot of wrecks due to a small amount of run-off space on the road course? “A lot of people are thinking that there are going to be quite a few wrecks on the track in Montreal, but they had a race last year with NASCAR Canada and it was not to bad at all. The show was fantastic. The guys on the last four or five laps kept passing each other and they kept fighting all the way to the finish. It was one of the most exciting races that we’ve seen so in the Busch cars it’s going to be exciting. I don’t think that you are going to see as many crashes or things that people expect. There is only one place near the pit road, they call it the Quebec wall, where if you miss the corner you are going to be in the wall like a street circuit. The wall is right there by the track so I’m sure you have to be careful. The other corners you have a little bit of run off area and you can come back on the track.”
What is a realistic goal for this weekend? “I’d like to be a top 10. If I’m top 10 then I will be happy with that. That is a good goal. I’m aiming higher than that. I hope to be in the top five, but realistically a top 10 after this long race I’ll be happy. For me I really want to try to show well and do well. I’m hoping to a little bit. We tested well yesterday and our crew chief Paul Wolfe made some changes that were really encouraging. He told me that maybe in Montreal we’ll be able to set it up well and if I race well we’ll end up there, but top 10 I would be happy with that.”
Do you see NASCAR as being in your future? “I don’t miss the open wheel. I’ve gotten calls from Rahal and a couple other teams that have wanted me to get back into it. I said, ‘No, we are going to focus on Busch.” I would like to spend a couple of years, I really like driving this kind of car. For me I like the ovals, I always have. I don’t want to do the ovals in the IRL anymore for safety reasons and I want to do it with NASCAR. I think the cars are a lot of fun. When I did CASCAR, NASCAR Canada, last year on the oval I had a blast. We’re aiming for it. We already have talks about doing an oval this year in the Busch Series, so that would be great. There seems to be a lot of interest from the sponsors to come in for next year, so hopefully we go that route.”
How important is it to be the top Canadian in Montreal? And which Canadian is going to be the toughest to beat? “I don’t know. Michael tested last week and was very fast. He is in a good car. I think he is in Juan Pablo Montoya’s car that he had in Mexico when he won the race. He is going to be fast and you can not undermine the experience of a guy like Ron Fellows who is going to be very fast. Not only is he going to be very fast but he is very patient and he really understands these cars. He is going to save his car all the way to the end of the race. I think he is going to come in at the end of the race also. I don’t know, honestly it all depends on the teams that we have and how good of job they do on the track over the weekend. It’s going to be really hard to tell. I would say Ron Fellows with his experience is going to be tough.”
Have you talked to Paul Tracy about how to bump guys out of the way? “No, not very much. I know from Paul that he has bumped me a couple of times. I haven’t talked to him. I have talked to Robby Gordon. I have talked to a few guys and they kind of explained to me a little bit racing in the Busch Series. I am trying to get as much information as I can from the right guys who will tell me the truth.”
Is there a voice that tells you since Montoya won at Mexico with little experience that you can do the same in Montreal? “Yes, but I don’t say it to loud. I don’t want to pressure myself. It would kind of be a dream comes true for me. It would help us motivate the sponsors for us to keep running in the Busch.”
DAYTONA BEACH, Fla. (July 31, 2007) – NASCAR announced today that Tony Stewart has been fined $25,000 and penalized 25 NASCAR NEXTEL Cup Series driver championship points, as a result of using inappropriate language during a post-race televised interview following his victory Sunday at Indianapolis Motor Speedway.Stewart, driver of the No. 20 Chevrolet, retains his fifth-place standing in the series points, with his total points reduced to 2,599.Stewart violated Section 12-4-A of the series rule book (actions detrimental to stock car racing) by using the inappropriate language.In addition, Stewart’s car owner, Joe Gibbs, has been penalized 25 car owner championship points because of the infraction.
- From NASCAR
A large portion of the company’s clients are from North Carolina: NCAE, SEANC, NC Center for Voter Education and the NC Beer Wholesalers Association. Politically, the Telephone Strategies Group works for Democrats, including the DNC and North Carolina Congressman Brad Miller.
The company is mostly known for voter contact services, like robocalls and live person ID, GOTV, and persuasion calls. I can only find evidence of two polls they have conducted; one for the realtors and another in Tennessee.
Given that the poll had only 20 questions and none were open ended leads me to think it may have been an automated poll, but there is no documentation either way. If anyone knows, please correct me.
Trident Racing's owner-driver, Richard Durivage is pleased to confirm that the Saint-Eustache-based team will field two entries in the forthcoming 'NAPA AUTOPRO 100' at Circuit Gilles Villeneuve, Montréal on Saturday 4th August - Round 6 of the 2007 NASCAR Canadian Tire Series Presented by Sirius Satellite Radio.
Durivage will return to the series behind the wheel of the #18 Chevrolet Monte-Carlo, enjoying primary support from Habitations Eric Alary with additional partners, CHOM 97.7 and La Ronde on-board for what is undoubtedly the highlight of the inaugural NASCAR Canadian Tire Series - this weekend's race supporting the first ever NASCAR Busch Series race in Canada, the 'NAPA Auto Parts 200 - Presented by Dodge'.
Habitations Eric Alary specializes in custom projects for new houses and renovations as well as hard wood flooring. Based out of St-Michel de Napierville, Québec, the company, run by 32-year-old Eric Alary, services Montréal and the surrounding area. Joining Habitations Eric Alary in supporting the #18 entry this weekend is CHOM 97.7 FM - better known as 'The Spirit of Rock' in Montréal, one of the most listened to radio stations in the city, and La Ronde, Québec's largest amusement park and part of the renowned Six Flags Family.
In addition to fielding Durivage, Trident Racing will run a second entry for the first time in its short history with France's Michel Disdier running the #46 Chevrolet Monte-Carlo in Montréal. The 33-year-old, a seasoned open-wheel racer and former French motocross champion, will make his stock car debut at the famed 2.71-mile Circuit Gilles Villeneuve road course.
While Disdier gets set for his maiden start, team boss Richard Durivage will be hoping to avoid the misfortune which blighted his race at the circuit last year. A blown clutch frustratingly ended his day early but the 38-year-old arrives this season armed with track knowledge and more seat time as he continues in his efforts to put together a full-time campaign for the 2008 season.
Having recently sold the team's entries in the NASCAR Whelan All-American Cummins Pro-Truck Series in order to concentrate further on the NASCAR Canadian Tire Series, Durivage is determined to make the most of Saturday's hometown appearance in Montréal.
"I'm delighted that we've been able to attract companies like Habitations Eric Alary, CHOM and La Ronde for this race," stated Durivage. "I know Eric (Alary) is a huge race fanatic and we're pleased to partner with him for our home event. Additionally CHOM and La Ronde are Montréal icons so we're honored to represent them this weekend. I'm excited that Michel Disdier is joining us as well, he's got a ton of road racing experience in Europe and I'm hoping that we have a strong outing together. This weekend offers us a great showcase as we look to the future of the team!"
The 'NAPA AUTOPRO 100' - Round 6 of the 12-race 2007 NASCAR Canadian Tire Series, starts on Saturday 4th August at 10am with TSN broadcasting the Montréal race as a tape-delay on Saturday 18th August at 2pm EST.
Produced by Stuart Morrison Public Relations
The back to back wins out west by the Milwaukee Electric Tools team have tightened up the point standings and created a tremendous enthusiasm for the NASCAR Canadian Tire Series. The dramatic last lap pass by J.R. in Edmonton for the victory have also added to the excitement and we’re only reaching the halfway mark of the season. “This Milwaukee Electric Tools Chevy team is really riding the wave right now” said Fitzpatrick. “I made some mistakes early on and we had a mechanical failure that hurt us at Barrie but we are on our game now. We’ve just got to keep working the way we did at the western events and keep it going now that we’re back in the east”.
This weekend will mark the second time that Fitzpatrick will participate in the Home Hardware Chevy at a NASCAR Busch Series event. Earlier this season he traveled to the Mexico City road course event. “It was such a great experience for everyone to go to Mexico and get a taste of the atmosphere surrounding the Busch Series. We’ve taken a lot of information and used the time to build our own car for this race and I really think it’s going to be a tremendous weekend”
Fitzpatrick has been looking forward to the first ever Busch Series event in Montreal since the race was announced. “We’ve kind of had this one highlighted for a long time” he smiled. “Everyone thought it was a great opportunity for us to show what we can do and to be in this first race in Montreal at such a challenging track will be very special”.
Adding to the excitement of the NASCAR Busch Series event will be several Cup series regulars that will also join the field. 2007 Daytona 500 winner Kevin Harvick, RCR teammate Jeff Burton is entered and so to are Carl Edwards and Greg Biffle. “I’m looking forward to seeing them on the track and talking with them in Montreal” said Fitzpatrick. “Anytime you can run with some of the best it’s positive and I think they’ll be pleased with how well all of the Canadian drivers perform this weekend in both races”.
After claiming their second straight victory JR Fitzpatrick and the Milwaukee Electric Tools team have jumped to second in the NASCAR Canadian Tire Series championship standings after five events.
The Milwaukee Electric Tools look to make it three straight wins as the NASCAR Canadian Tire Series will race next at Circuit Gilles Villeneuve in Montreal on August 4th. JR will race the Home Hardware Chevy the same day in the NASCAR Busch Series event. More information can be obtained by visiting www.nascar.ca You can watch J.R. and the Milwaukee Electric Tools Chevy race to victory at Vernon & Edmonton and all NASCAR Canadian Tire Series events on TSN.
This release prepared by TL Sports & Entertainment
With support from Dwight Kennedy and Northern Provincial Pipelines DJ Kennington has participated in several Busch Series events already this season working with fellow Canadian Randy McDonald and had some very strong outings. We had a great run at IRP last weekend picking up at 25th place finish. That really helped a lot. It gave us a confidence boost and like every weekend we learned more about the car and the series”.
With this being the first ever NASCAR Busch Series race held at Circuit Gilles Villeneuve it will also bring out several Cup series regular drivers like Daytona 500 winner Kevin Harvick, his RCR racing teammate Jeff Burton, Greg Biffle and Carl Edwards. Kennington is looking forward to participating this weekend with some of the best stock car racers in the world. “It’s always great to measure yourself against some of these racers” said the Castrol Dodge pilot. “It’s also a real opportunity to learn from them. Whenever I get the chance to see how they’re working a particular corner on the track and talk with them in the garage I make the most of it”.
Kennington also knows that running both races this weekend as well as other select Busch series events presents unique challenges to the Castrol Team. “The toughest part for us is that we’re not full-time participants in the Busch series and we have to get up to speed quickly at each race”. said Kennington. “The long days and nights that all of the crew put in is really something they should be proud of, I’m proud of their effort and they should be too”.
After five races DJ Kennington and the Castrol Dodge team sit fourth in the overall NASCAR Canadian Tire Series point standings.
The NASCAR Canadian Tire series race will precede the NASCAR Busch Series event this coming Saturday, August 4th at Circuit Gilles Villeneuve on Ile Notre Dame in Montreal. The twelve race NCATS schedule features events from coast to coast in Canada including stops at the best ovals in the Country along with temporary street circuits in Edmonton and Trois Rivieres. Look for more information all season at www.nascar.ca All twelve races of the NASCAR Canadian Tire Series will also be broadcast on TSN.
This release prepared by TL Sports & Entertainment
Long time racer Jud Buchanan of Campbelville, Ontario took his restored/super-tuned 1967 Acadian Canso to Newfoundland finishing 3rd overall in the inaugural Targa Rally Race in 2003.
He podiumed 3rd overall again in ’04 then down a notch to 4th in 2005. Last year in the ’06 edition of the Canada’s highest profile tarmac rally, Jud and co-driver Jim Adams, of Pickering, ON ran in the top three overall for the entire rally. Suddenly disaster struck preventing the team from top spot; leading the rally by 16 seconds a transmission failure limped them to 2nd place in the final special stage of the rally.
“This year, thanks to Castrol’s sponsorship, we’re bring home the trophy,” promises Buchanan. He certainly knows how to win with a slew of autoslalom championships dating back 25 years and 1st place in the 2002 Yokohama Winter Rally Series on his mantle.
Anthony Stadelman, Wakefield Canada’s director of marketing, notes that Castrol has been a principal Targa sponsor since the beginning and has seen Buchanan win his Classic class several times. “It’s now time for Jud to switch from being the bridesmaid! This year we want to see Jud win the whole thing,” Stadelman says in his role as chief cheerleader.
Follow the Buchanan/Adams driven Canso at Targa Newfoundland beginning September 8, 2007.
Castrol Motorsport for 2007
Castrol’s track heritage spans more than 100 years during which the company has sponsored everything from Land Speed Records to John Force’ fabled NHRA Funny Car career. In Canada, Castrol is the founding sponsor of the Canadian Motorsport Hall of Fame and was a long time significant sponsor of CASCAR during that organization's many seasons.
This year the company has helped establish one of the country’s most successful ever series racing series for touring cars titled the Castrol Canadian Touring Car Championship. Also for 2007, Castrol has expanded its participation in the Canadian Rally Championship through the creation of the Castrol Cup. The Castrol Cup will provide a major prize fund for the Canadian Rally Championship with significant cash prizes to be awarded participants in the championship.
Elsewhere, Castrol has added its sponsorship weight to an emerging series in the Alberta/B.C. region announcing the Western Canadian Drift Championship presented by Castrol. With a four-round series running in Calgary, Edmonton and Vernon, this series nicely compliments the Castrol Drift Mania Canadian Championships (DMCC) that runs in Eastern Canada.
Castrol’s long time stock car presence continues in 2007 aboard DJ Kennington’s Number 17 car in the NACAR Canadian Tire Series and Kevin Dowler’s hard driving programs. The title sponsored multi- faceted facility, Castrol Raceway in Edmonton and many other sponsoring roles with drivers and series all over Canada contribute to an unprecedented Canadian motorsport summer for the Castrol brand.
For more information: John@marcovitchpr.ca; 416 963-3222
NASCAR drivers Michael Waltrip and David Reutimann will be in Mississauga on August 1 to celebrate the NAPA AUTO PARTS 200, the first NASCAR race in Canada and join NAPA Auto Parts in celebrating the opening of its new store at 1825 Dundas Street East, in East Mississauga (between Dixie and the 427).
Michael and David will meet with NASCAR racing fans and sign autographs from 1:00 pm to 2:45 pm at the NAPA Auto Parts East Mississauga Store. The event is open to the public with NASCAR consumer products for sale and door prizes to be awarded including tickets to the NAPA AUTO PARTS 200 to be held at Montreal’s Circuit Gilles Villeneuve on Aug. 4.
David Reutimann is the driver of the #00 Domino's/ Burger King Nextel Cup Toyota Camry and will be driving the #99 NAPA Auto Parts Toyota Camry in the NAPA AUTO PARTS 200. David is currently the second in Busch series points.
Michael Waltrip is a two-time Daytona 500 winner and currently drives the #55 Napa Auto Parts Toyota Camry in the Nextel cup series. Michael Waltrip Racing also owns the #44 UPS Toyota Camry driven by Dale Jarret and the #00 Toyota Camry driven by David Reutimann.
The NAPA AUTO PARTS 200 will be the third road course race and will feature the NASCAR Busch series’ spectacular drivers and more than 40 of its powerful V8 700 HP stock cars. The NAPA AUTO PARTS 200 is poised to become one of the most attractive sporting events in Canada.
“I think it will be a fantastic night for the series,” series administrator Kathy Nicholson said. “I know all our drivers are looking forward to the night, especially with the changes to the regular format.”
The change Nicholson is talking about is that the Ontario Pro Challenge drivers will do a two lap – combined – qualifying session to set the grid instead of the usual heat races to set the grid for the feature.
“This is a new thing for all our drivers, and I am sure each will be pushing hard to get on the pole for the 50 lap feature,” Nicholson added.
The Ontario Pro Challenge Series is a fan favourite wherever they travel, and when they head to Sunset Speedway this Saturday, the fans won’t be left out. “After the qualifying, a lucky fan will draw a pill out of the back to see how many places we invert for the 50-lap feature,” Nicholson said.
After the lucky fan picks the inversion, the cars will be lined up in that order and the 50 lap feature will begin. Clearly it will be a big night for not only the drivers, but the fans of the series as well.
Racing action will kick off at Sunset Speedway on Saturday night at 6:00pm, and the Ontario Pro Challenge Qualifying is set for 8:00 pm – 8:30 pm.
For more information and directions to Sunset Speedway, visit www.sunsetspeedway.ca
Ontario Pro Challenge Series Fast Facts;
The Ontario Pro Challenge Series (www.prochallengeracing.com) is a touring stock car series in Southern Ontario. The Pro Challenge Cars are spec ¾ scale, tube framed Nextel Cup styled cars powered by sealed Kawasaki Ninja 1100cc engines. The 12 race series travels throughout Ontario’s oval racetracks during the summer. For more information on the Ontario Pro Challenge Series, contact Kathy Nicholson at 519-754-2001 (firstname.lastname@example.org). or Russ Bond at 905-852-2900 (email@example.com)
Release prepared by Russ Bond Agency
Amgen and Johnson & Johnson got some good news when the Centers for Medicare & Medicaid Services finalized its proposed policy on coverage of erythropoietin stimulating agents (ESAs) in cancer patients. The final policy is about as good as it could be for the companies under the circumstances—much better than the agency originally proposed.
CMS agreed to continue to cover EPO in a number of important chemotherapy settings and also dropped some of the toughest dosing restrictions in the proposed policy. So the worst may be over for darbepoetin (Aranesp) and epoetin (Procrit) in the cancer market. Both Amgen and J&J reported sharp revenue declines for their respective brands during the quarter in response to safety concerns—and especially payment changes—but both expect growth to resume from the new, lower baseline.
CMS may have backed off from the most draconian aspects of its proposed limits on EPO coverage, but the agency is not backing off from the position that it does not have to defer to the Food & Drug Administration when it comes to responding to emerging drug safety issues.
In that sense, the final coverage policy is not a change from the agency’s initial proposal—and that is a message that the rest of the biopharmaceutical industry cannot afford to miss.
The RPM Report has written extensively about the activist role taken by CMS in the EPO safety debate. Simply put, there are now two agencies—FDA and CMS—that manufacturers have to consider when thinking about regulatory responses to drug safety issues.
CMS made it abundantly clear in the proposed EPO policy that it does not intend to wait for FDA to finalize its review of the safety issues before acting. And in the final policy, CMS is sticking to that position.
“CMS and FDA are separate agencies with different statutory missions, and operate under distinct legal authorities,” the final policy notes. “We are encouraged that the separate and independent analyses of the FDA and CMS have raised similar serious concerns about the use of ESA treatment in patients with cancer and related neoplastic conditions.”
“FDA deliberations are not public and their timeline for making changes (if any are made) in the labeling for ESAs is unknown. We believe the safety concerns that we have identified in this document required CMS to act quickly to protect beneficiaries.”
There are still plenty of regulatory hurdles ahead for ESAs. FDA hasn’t finalized labeling changes for EPO in response to the safety issues—and both FDA and CMS are just getting started on reviewing use of the agents in the renal failure market.
But one thing is clear: CMS is not going to take a back seat to FDA when safety issues arise.
By Jim Clarke, Kawartha Speedway PR
Kawartha Speedway and Brighton Speedway Park have teamed-up to present the 2007 edition of the Fast and Furious Weekend. 2 shows, back-to-back Friday, August 10th on the paved 3/8ths of a mile layout at Kawartha and Saturday, August 11th on the tight, 3rd of a mile clay at Brighton.
Kawartha Speedway’s show features the second visit of the year by the fastest cars on Canadian pavement, the OSCAAR Outlaw Super Late Models and the Ontario Legends. The pair of touring groups will join Kawartha’s Late Models and the Discount Car and Truck Rental Mini Stocks. During the 50 lap Mini Stock invitational July 6th at Kawartha, a number of Brighton cars were entered and just as many are likely to attend Friday, August 10th.
Your double-header racing weekend continues the next night at Brighton Speedway Park. The popular oval, promoted by Mark and Angela Rinaldi is celebrating its 40th anniversary season and will feature a regular show - plus the ground-pounding Southern Ontario Sprint cars - Saturday, August 11th.
NASCAR Busch Series Makes Inaugural Stop in Montreal with NAPA Auto Parts 200 Live on TSN and TSN HD, this Saturday
Kevin Harvick, the reigning Daytona 500 winner and two-time NASCAR Busch Series champion, leads the list of big-name drivers competing in Montreal. The field also includes current Busch points leader Carl Edwards, Jeff Burton, who has won 24 races on the Busch circuit, and Robby Gordon, whose resume boasts three NASCAR NEXTEL Cup Series victories, a NASCAR Busch Series win and five Top-10 finishes at the Indianapolis 500.
The Canadian contingent at the NAPA Auto Parts 200 features such popular drivers as Quebec's Patrick Carpentier, the local favourite who is making his NASCAR Busch Series debut behind the wheel of the Fitz Motorsports Dodge, veteran Ron Fellows of Mississauga, Ont., one of the most distinguished and accomplished Canadian NASCAR drivers ever, and 19-year-old J.R. Fitzpatrick of Cambridge, Ont., the 2006 CASCAR champion.
TSN's Brent Wallace will be on site at Circuit Gilles Villenueve providing reports for SportsCentre, including a post-race wrap-up on Saturday that will include a one-on-one interview with the winner of the race.
Fans in attendance at Circuit Gilles Villeneuve on Saturday will be able to watch NASCAR Canadian Tire Series' (NCATS) sixth race of the season. The 23-lap race takes place at 10 a.m. ET just prior to the Busch Series qualifying. The NCATS-Montreal race will air on TSN and TSN HD on August 19 at 12 noon ET.
TSN's NASCAR coverage is the most comprehensive ever this season, with live coverage of 30 NASCAR NEXTEL Cup Series races, all 35 NASCAR Busch Series races, and highlight shows of the entire 12-race NASCAR Canadian Tire Series. All NASCAR NEXTEL Cup Series and NASCAR Busch Series races are available in High Definition on TSN HD.
TSN, a division of CTVglobemedia, is Canada's Sports Leader. Setting the Canadian sports broadcasting standard, TSN's flagship news program, SportsCentre, was voted the number-one source for sports news by sports fans from across the country.* TSN's comprehensive broadcast schedule also features the NHL and first three rounds of the Stanley Cup Playoffs; Toronto Maple Leafs hockey; International Hockey including the IIHF World Junior Championship; the Olympic Games through 2012; CFL including Friday Night Football; NFL including Sunday and Monday Night Football; PGA TOUR and all four golf Majors; Season of Champions Curling; NASCAR including the Daytona 500; Formula One including the Canadian Grand Prix; IRL including the Indy 500; Blue Jays baseball; Raptors basketball and the NBA Finals; Tennis and all four Grand Slam events; EURO 2008 and UEFA Champions League Soccer; and HBO World Championship boxing. TSN HD offers more sports coverage, more hours and more events in High Definition than any other network in Canada, reinforcing TSN's position as Canada's Sports Leader in High Definition. TSN is available in 9 million households. TSN's programming and news content is also available online at TSN.ca.
Claiming bias is also a good way to avoid having to analyze polling results. Just cast the results aside as biased and you’re done with it. The N&O fell in that trap yesterday when discussing our recent Raleigh survey concerning Dorothea Dix Park. Ryan Beckwith makes the observation:
A follow-up question asked if voters would support leasing a smaller section of the park, but it's tainted by wording of the "historic core" that is "crucial to the success of a future destination park."
Fair enough. But he doesn’t report the results of the question, and most importantly misses the fact that while he considers the wording tainted, it is still true. Sometimes the truth is biased and that’s not a bad thing. Bias is also a matter of opinion. Some may consider a question biased, while others disagree. Some polling questions are also intentionally biased as a scientific way to measure the strength of an argument.
I tried to avoid simply claiming bias when discussing the most recent poll released by the NC Association of Realtors. The poll was biased, no doubt. But instead of claiming bias and walking away, I tried to point out instances when the question wording was not just bias, but factually inaccurate or misleading.
I didn’t further analyze the results of that poll on this blog, but there are lessons to be learned from the results. And in counties that will now face a transfer tax referendum, I suggest people look at these poll results for insight into how their pro-and-anti-transfer tax campaigns should be run.
Even in the face of bias we shouldn’t be scared to analyze, there is still something to be learned. Factual inaccuracy, however, is a different story.
Monday, July 30, 2007
But they voted 20-3 that Avandia increases the cardiac ischemic risk in type 2 diabetes. What an odd vote.
We don't think it means very much and that Avandia, for all intents and purposes, is dead. See our previous post below. What do you all think?
The final blow to GlaxoSmithKline's diabetes drug Avandia was not delivered by FDA whistleblower and director for science and medicine in the office of surveillance and epidemiology David Graham, although he gave the most persuasive presentation during the morning session of today's advisory committee meeting on the troubled product. It was his boss, drug safety director Gerald Dal Pan.
Graham gave the last presentation before lunch and predictably came to the conclusion that Avandia should be pulled from the market. He went through a detailed, half-hour talk explaining why he came to his conclusion, using a combination of results from long-term, placebo controlled studies, and meta-analyses to show rosiglitazone's benefits did not outweigh its cardiovascular risks.
"There is no evidence, none whatsoever, to support the benefits of rosiglitazone with these outcomes," Graham said refering to a host of cardiovascular adverse events including heart attack. He paralleled the Avandia situation to Warner-Lambert's Rezulin, saying it had cardiovascular risks other drugs (read Takeda's Actos) in the class did not have. Rezulin was pulled for showing fatal liver toxicities other drugs in the class did not have (read our earlier post).
Everyone expected that from Graham. But it was Dal Pan's endorsement of Graham's findings that effectively killed this drug, even if it does stay on the market with a black box warning. If Glaxo's legal team wasn't already in crisis management mode, they certainly will be now.
Dal Pan was noticeably reserved about the meta-analysis finding of a 43% increased risk of heart attack linked to Avandia during an early July Congressional House hearing. He was not ready at that point to make any determination on Avandia. Now, he has reached his conclusion: it should be pulled. The benefit/risk profile of Avandia "is not favorable" Dal Pan concluded.
Best case scenario for Glaxo, Graham says, is that Avandia was responsible for 40,000 excessive cardiovascular events in 6.5 years since 1999. Graham puts the real number at 80,000 excess cases. A real nightmare, if true.
Dal Pan gives credibility to Graham's findings that did not previously exist. The only reason the Office of Drug Safety did not make a formal withdrawal recommendation is that the whole drug safety team had not had a chance to review the analysis as of yet, according to Graham.
There is clearly a line in the sand between the Office of New Drugs and the Office of Surveillance and Epidemiology (drug safety) within FDA's Center for Drug Evaluation & Research. OND wants to keep it on the market, OSE wants it off. CDER office of drug evaluation II director Robert Meyer argued eloquently against Graham and Dal Pan's conclusions, adding that he himself had not decided on the appropriate "regulatory action."
But that doesn't mean much anymore. Whether or not it stays on the market, GSK's Avandia is dead.
The city of Raleigh is currently attempting to buy the Dorothea Dix property from the state government in order to turn it into a city park. Would you support or oppose an 80 million dollar bond referendum to help the city purchase Dorothea Dix?
The state government may offer to lease the city of Raleigh approximately 200 of the 306 acres of Dix land for 99 years on the condition that Raleigh would spend millions to improve the land as a park. However, the state offer would not include the main hill and historic core of the Dix property. Dix Park advocates claim that the historic core is crucial to the success of a future destination park. Should Raleigh accept or reject such an offer from the state?
Complete results here.
(BOWMANVILLE, ON – July 30, 2007) The powerful stock cars of the NASCAR Canadian Tire Series are set to make their second visit to Mosport, this time at the Speedway, as Canada's top stock car drivers take to Canada's fastest half-mile oval in the Full Throttle Energy Drink 200 presented by Canadian Shield Anticrime Response Corporation on Saturday, August 11.
The NASCAR Canadian Tire Series is the nation's top-level stock car championship, and features drivers such as current points leader and former Champ Car racer Andrew Ranger of Roxton Pond, Quebec (who won the Dickies 200 at Mosport International Raceway on Father's Day Weekend) and 2006 national stock car champion JR Fitzpatrick of Cambridge, Ontario.
Among the other veteran racers that will be on the starting grid, are past Mosport Speedway winners DJ Kennington of St.Thomas, Ontario and Dave Whitlock of Petrolia, Ontario and five-time national champ Don Thomson, Jr. of Ayr, Ontario.
In addition to the exciting racing action taking place on-track, the Speedway's got some great attractions off-track too. The Canadian Tire Fast Track Tour will be on hand inside the front gates to entertain and educate race fans. It's an interactive attraction built for those with the need for speed. You can test your NASCAR/ Canadian Tire knowledge and learn more about Canada's rich racing history, and see if you've got what it takes on the Playstation simulator.
The gates open at 2:00 p.m. and time trials are set for 4:00 p.m. Fans will also want make sure they bring their pens and posters for the driver autograph session that will get underway at 5:00 p.m. on the front straight. The green flag for the Full Throttle Energy Drink 200 presented by Canadian Shield Anticrime Response Corporation, a 200 lap, 100 mile race, drops at 7:00 p.m.
Advance tickets are just $25 until August 8 ($30 at the Gate) and parking is free. Children 12 and under are free when accompanied by a paid adult admission.
From Mosport Speedway // Lee Bailie, Mosport
Thorold, Ontario (July 30) When Race fans and race teams arrive at Merrittville Speedway Monday August 6th – they can expect quite an event as the Thorold Track hosts it’s biggest race of the season when the Advance Auto Parts Super DIRTcar Series makes a visit for the 100 lap Trevor Wilkens Memorial.
“It’s a big event for us,” relates (Merrittville GM) Erica Bicknell, “and it just got huge as we’re ecstatic to announce the launch of As the Dirt Flies … it will be a pre-race like no other.”
Race fans surely tune in to SPEED weekly for the latest Trackside and Hollywood Hotel type pre-race shows and that experience will make its debut on the deck of Dipper’s Turn 1 Bar August 6th.
As the Dirt Flies will be anchored by Merrittville’s Announce Team of Erik Tomas, Clinton Geoffrey and Fran Buschardt with a special guest host – Shane Andrews – the voice of the Advance Auto Parts Super DIRTcar Series in addition to the Brewerton, Fulton and Cayuga County Fair Speedways.
“Drivers … DIRTcar Officials and the announcers will mix it up when the live unfiltered pre-race show premieres,” adds Bicknell, “the latest news … inside scoops … As the Dirt Flies will get everyone pumped up and ready for the adrenaline rush of the Toolneeds Big Block Spectacular.”
As the Dirt flies will feature visits from DIRTcar Series Officials Cory Reed, Tom Skibinski, Gary Spaid and Dave Farney, select Big Block Drivers and Merrittville Speedway’s 358 Modified home town heroes.
Farney will also join Merrittville Speedway Starter Doug Leonard up on the Starter’s Stand for the night and when the checkered flag drops on the 100 lap Main Event – you’ll probably see four of them flying in a double double salute to the race winner.
Be a part of the As the Dirt Flies crowd at Merrittville Speedway when the gates open at 4:00 prior to the Club Castropignano Pasta Dinner that begins at 4:30. Bring your lawn chair and enjoy one of the best deals on dirt and get settled in for the Countdown to Green that begins at 5:00.
For the last couple years, Merrittville Speedway has welcomed the staff from Club Castropignano for a taste of dirt racing and with their Pasta Dinner – you can’t go wrong – Pasta and Meatball, Salad, Dinner Roll and a Pepsi for just $10 and you won’t go away hungry.
Pasta Dinner Tickets must be purchased by the close of Saturday August 4th’s Dirt Weekly Racing Series Event however.
To purchase yours – call 905-892-8266 or stop by the Speedway Office during business hours. When Hingston Metal Fabricators presents another episode of the Marshall and its Motorcycle Show and Shine August 4th – Tickets will be available for the final time from either Dipper’s Turn 1 Bar or the Merrittville Speedway Novelty Trailer located just inside the front gates.
Your local Dirt Track is where it’s at and it’s at Merrittville Speedway Monday August 6th. The star studded Advance Auto Parts Super DIRTcar Series Big Blocks are set to challenge our home town heroes in the 100 lap Trevor Wilkens Memorial presented by Toolneeds. With plenty of free camping, the Club Castropignano Pasta Dinner and much more – it’s puts Merrittville Speedway on the map as a must see event. It’s been a Holiday Tradition since 1972 – make it yours in 2007! To learn more call 905-892-8266 or visit www.merrittvillespeedway.com.
For Immediate Release // From Jim Irvine - Merrittville Public Relations
Clermont, Ind. (July 27, 2007) - Peter Shepherd knew he would be going to school when he got to O'Reilly Raceway Park (ORP). The young driver had never been to the challenging .686-mile oval but was well aware of the challenges he would face as he made his first laps around the legendary speedway.
Shepherd struggled to get comfortable with the racetrack in the first practice session, but got faster with each lap. By the end of the final session, Shepherd's No. 50 Northern Tool + Equipment Ford had shot up the charts to the fourth position, leaving Shepherd and crew feeling good about their chances. When rain began to fall at the end of the final practice session, it dampened more than just the racetrack. The spirits of the No. 50 crew were crushed when qualifying was canceled, setting the field by 2007 owners points.
Shepherd started in the 21st position, but began to drop positions in the early going. By the time the first caution flag flew at lap 31, Shepherd showed in the 25th position. He reported to the crew that he was fighting a tight condition and that the Northern Tool + Equipment Ford did not want to rotate through the corners. With some of the leaders electing to come to pit road for service, Shepherd restarted in the 20th position when the green flag was displayed at lap 43.
Shepherd continued to make the most of his handling problems, completing laps and staying out of trouble until he had a chance to come to pit road for adjustments. Shepherd got the break he needed at lap 77, when an incident between the No. 10 and 61 trucks brought out the caution flag. Shepherd came down pit road to the attention of the Northern Tool + Equipment crew for tires, fuel and a track bar adjustment. Shepherd restarted in the 21st position, and would continue to hold the position for the next several laps.
Shepherd seemed to be in position to bring the Northern Tool + Equipment Ford home with a solid finish and all four fenders in place when the No. 16 truck of Kenny Hendrick made contact with Shepherd in turn four, sending the No. 50 into the outside wall. Shepherd came to pit road for tires and damage repair, returning to the track one lap down to the leaders. Shepherd managed to make it to the checkered flag without further incident, but the dejected driver was obviously upset with the way his day ended.
"We had a little bit of a rough day," said Shepherd. "The rain kind of hurt us today. We were fourth fastest in practice but we didn't get a chance to qualify. Track position is very important here. It's nearly impossible to pass. We kept making adjustments to the Northern Tool + Equipment Ford F-150 but couldn't get it just right. We got hit and taken about by the 16 (Kenny Hendrick) there towards the end. That was pretty unfortunate. We came in and got some new tires and we were really good in the closing laps. We were trying to get everything we could back out of it. We fell back pretty far after that and fought to get back towards the front. I'm disappointed for all the guys. Everybody was working really hard. We did the best we could."
The Craftsman Truck Series next competes at Nashville Superspeedway on Saturday, August 11.
About Northern Tool + Equipment
Northern Tool + Equipment has been a supplier of high-quality tools and equipment for more than 25 years, selling products through direct mail, the Internet and at nearly 60 retail locations in 11 states. Along with a deep selection of hand, power and air tools, Northern Tool + Equipment carries a wide variety of products, including generators, pressure washers, air compressors, hydraulics, small engines, trailers, water pumps, tractors, welding equipment and much more. Northern Tool + Equipment also serves as the exclusive distributor of NorthStarTM brand equipment, which is fabricated and assembled at the company's 250,000 sq. ft. manufacturing facility. For more information, visit www.northerntool.com.
About Roush Fenway Racing
Roush Fenway Racing is NASCAR's largest team operating 14 motorsports teams, five in NASCAR NEXTEL Cup with drivers Matt Kenseth, Jamie McMurray, Greg Biffle, Carl Edwards and David Ragan; five in the Busch Series with Kenseth, Biffle, Edwards, McMurray, Ragan, Todd Kluever, Michel Jourdain Jr. and Danny O'Quinn Jr.; and three in the Craftsman Truck Series with Edwards, Peter Shepherd, Travis Kvapil, Erik Darnell and T.J. Bell; and one in the ARCA/REMAX Series with Colin Braun and Darnell. For more information on any of the Roush Fenway Racing teams, log onto www.RoushFenway.com. For sponsorship inquiries please contact Robin Johnson at 704.720.4645.
From Rory Connellan, Roush Fenway Racing
By DARCY MACRAE // THE TELEGRAM
Although J.R. Fitzpatrick’s is making his first visit to Newfoundland, the 19-year-old race car driver is proud of his roots in this province.
Fitzpatrick, an up-and-comer in NASCAR (National Association for Stock Car Auto Racing), soaked up the sights and sounds of St. John’s during a quick drive through downtown Thursday, never taking his gaze off the historic buildings of Water Street or the boats coming and going through the narrows. The native of Cambridge, Ont., was impressed with what he saw and particularly happy to finally get the chance to travel to Bell Island, where his father, John Fitzpatrick, grew up.
“I always wanted to come here since I was a little kid,” said Fitzpatrick. “It’s a very beautiful place. It’s a very relaxing place, it doesn’t seem as busy as back home.”
... continued at the link above
According to insiders, the top internal candidate is Martin Mackay, who spent most of his nearly 12 years at Pfizer on the discovery side; he’s only been running development since the beginning of the year.
But all the insiders and outsiders we spoke with think that Pfizer CEO Jeff Kindler will need to look externally, too (we understand he's using Spencer Stuart on the search).
Insider or outsider, however, he'll want someone who can straighten out the maze--cultural, bureaucratic, and physical--created from Pfizer's series of acquisitions. Not just the big ones, Warner-Lambert and Pharmacia, but also the myriad of biotechs, plus Pharmacia's acquisitions, too--many of which hadn't been fully integrated when Pfizer bought it.
Perhaps unsurprisingly, not a lot of names dropped from the trees we shook (mostly recruiters at a variety of white-shoe firms). “Who would want that job?” they chorused. Most obviously, Pfizer’s got an enormous challenge in replacing Lipitor in 2011 – a no-win situation, they said, even if the new guy creates the sleekest, best-looking R&D organization in the industry.
Or could there be a way out after all? We think maybe there could. Granted, if Vytorin and generic Zocor continue to munch away at Pfizer’s share of the statin business at the current rate, Pfizer could see $11 billion Lipitor turn into a $5 billion drug several years before patent expiration. In that case, Pfizer stock could reach the floor pretty soon. That's bad news for lots of employees (the layoff program will speed up) but it's good news for a new R&D chief (and his stock options): starting at the bottom is better than starting on a downward slope.
Plus, given all the corporate motivation provided by the loss of billions in revenue, the R&D boss would clearly be allowed to make some big changes--something that stymied previous R&D chiefs, in particular Peter Corr, who was pushed out of the job.
What's more, there are plenty of people who would simply love the ego boost that comes from managing a $7.4 billion budget.
So, we asked, which outsiders is Pfizer likely to approach? Our sources put them into two groups: the usual suspects and the less usual ones. In this post, we'll go through the former group. Tomorrow, we'll consider the less likely candidates.
Bob Ruffolo, Wyeth’s by-the-numbers R&D boss. He’s certainly shaken up the organization, but no one expects him to budge before he sees some of the fruits of his restructuring.
John Patterson, now a board member and head of development at AstraZeneca, the driver behind the effort to root out AZ’s nearly fatal NIH syndrome, and the architect of the industry’s most ambitious business development program.
Joerg Reinhardt, now CEO of Novartis Vaccines and Diagnostics, and the former development chief. But Reinhardt is joined at the hip with CEO Dan Vasella and probably will be his successor, say the jungle drums.
Jeff Leiden, former head of research and COO at Abbott, now a partner at Clarus Ventures (not, like the other senior folks at the fund, a "managing director" -- whatever that distinction means). Was a star academic physician (and a founder of several biotechs) before joining Abbott and would certainly add a start-up shine to Pfizer.
All of these folks would be relatively safe choices for Pfizer--execs with street cred. But Pfizer will need to do a terrific sales job to get any one of them.
- Pretty soon they'll be putting it in the water. A couple pieces in the UK Guardian over the weekend about the potential fluoridization of statins in the UK. Followed up this morning, here, is the plan's downside.
- GPC Biotech continues to deal with the wake of its satraplatin review. Late Friday night the company reported the first class-action lawsuit it will face. And over the weekend Reuters reported that GPC's largest investor, SAP co-founder Dietmar Hopp, increased is stake in the company to more than 14% as its shares have slipped.
- A new use for those old pills. The AP reports on drug-disposal companies that can turn pharmaceuticals into energy.
- Finally, a big day for Avandia today ... more to come on the IN VIVO Blog.
Friday, July 27, 2007
ST-EUSTACHE, QC – Top American-Canadian Tour (ACT) stock car drivers Jean-Paul Cyr and Patrick Laperle are each in search of their first main event victory of the season, and will be taken to task at the $43,000+ ACTion Super Series 200 at Autodrome St-Eustache on Saturday night at 5:30pm. The flat 4/10-mile race track, located just 10 minutes from Montréal, is expected to draw more than 40 teams from the United States and Canada to the $6,000-to-win combination event for the ACT Late Model Tour and the Série ACT Castrol.
Milton, VT driver Cyr leads the ACT Late Model Tour point standings entering Autodrome St-Eustache. Despite a string of five-straight podium finishes to open the season, he has yet to win a race.
“We should have had three or four (wins) by now,” said the six-time ACT Late Model Tour Champion. “We’ve been running well, but we just haven’t been lucky enough to win yet.” Cyr was the runner-up at the New England Dodge Dealers 150 at Maine’s Oxford Plains Speedway in April, and has since turned in four consecutive third-place finishes.
Like most of the American drivers entered in the ACTion Super Series 200, Cyr has never raced at Autodrome St-Eustache. “I’ve never even seen the place,” he admitted. “I have a plan in my head on how to attack the race track, but we could get there and have to scrub the whole thing. It’s a situation where you have to think a lot.”
Laperle is now focusing his efforts on the Série ACT Castrol title chase in his native Canada, and currently ranks fourth overall on the strength of six top-ten finishes. The St-Denis, QC racer was within 15 laps of winning an event at Autodrome St-Eustache in May before he crashed with Sylvain Lacombe.
“I think our car will be in better shape for the 200 this weekend than it was in the spring,” Laperle said. “We could have won the last time we raced at St-Eustache, but now the car is performing the best it has been all year.”
Cyr and Laperle share a common goal in aiming at the $6,000 top prize in the ACTion Super Series 200. “The money in the Super Series races is always good,” said Cyr. “It’s nice to win any race, but Super Series wins are a better reward for all of the hard work the team puts in on the car.”
Laperle agreed, saying, “I won a Super Series race (2005 Vermont Milk Bowl at Thunder Road), and the money is good for a small family team like mine. I hope I do well in front of my home crowd at St-Eustache and win that money.”
Cyr and Laperle will square off against each other and the likes of Lacombe brothers Sylvain and Martin of Terrebonne, QC, Brent Dragon and Scott Payea of Milton, VT, Donald Theetge of Boischatel, QC, and Groveton, NH’s Randy Potter. Also gunning for the win will be “Rocket” Roger Brown of Lancaster, NH, winner of the TD Banknorth 250 at Oxford Plains last Sunday.
Qualifying events for the ACTion Super Series 200 are scheduled to begin at 5:30pm. Autodrome St-Eustache is located on Boulevard Arthur-Sauvé in St-Eustache, QC, just outside of Montréal and Laval. More information, call (802) 244-6963 or visit www.acttour.com .
From ACT / Justin St. Louis
“This is a wonderful partnership,” said Robert Yates, founder of Robert Yates Racing. “This gives us a clear vision how to get to the top. It is our goal to continue to build so this team will be better positioned to contend for the championship.”
“I am very proud of our accomplishments in the Champ Car World Series and hope we can have the same success in NASCAR,” added Carl A. Haas, who has been a team owner in NASCAR’s Cup series on two previous occasions. “We have been looking to add other forms of racing to our Champ Car program and when the opportunity came along to work with Robert Yates Racing, a team that shares the same drive for success that we do, it was too good of an opportunity to pass up. I think that the NASCAR and Champ Car programs can learn something from each other and only enhance the championship level that Robert Yates Racing and Newman/Haas/Lanigan Racing have competed at in previous years.”
“We have always been an engineering driven team,” said Paul Newman, a partner in Newman/Haas/Lanigan Racing. “We think we have something special to add to the benefit of both. This in no way lessens our commitment to open wheel racing -- we want to broaden our horizons.”
“The opportunity of joining Robert and Doug Yates is an opportunity of a lifetime,” added Michael Lanigan, a new partner in Newman/Haas/Lanigan Racing. “The Yates family has been competing against the best and winning for many years. We look forward to a long and productive association.”
Since Robert Yates Racing was formed in 1988, the now two-car team has posted 57 victories and 48 poles in addition to winning the 1999 NASCAR championship with Dale Jarrett. Current Nextel Cup drivers Ricky Rudd and David Gilliland pilot the No. 88 and No. 38 Ford Fusion’s, respectively. The agreement also includes RYR’s Busch program with Stephen Leicht, driver of the No. 90 Ford Fusion. Drivers such as Davey Allison, Ernie Irvan, Dale Jarrett, Ricky Rudd, Kenny Irwin, Elliott Sadler and David Gilliland have driven for RYR.
RYR and NHR/NHLR have had close ties with Ford Motor Company for many years. RYR has been powered by Ford all 20 seasons. Of NHR/NHLR’s 101 wins and 103 poles, 55 of each have been earned with Ford power. In addition, four of their seven titles were powered by Ford (1993 – Nigel Mansell; 2004-2006 – Sebastien Bourdais).
“NASCAR Nextel Cup racing is rapidly moving, technology-wise, to engineering areas that Newman/Haas/Lanigan has years of experience with already,” said Dan Davis, director of Ford Racing Technology. “And Robert Yates Racing brings years of engine development and race craft in the sport that is invaluable to this operation. Put that expertise together, along with joint ownership that is clearly committed to winning, and we have a Ford program that will be a contender for years to come."
About Robert Yates Racing …
Robert Yates Racing was formed in 1988 by Robert Yates and the team is in their 20th season. In the premier series, they have won 57 races, 48 poles and one championship with Dale Jarrett (1999). Drivers such as Davey Allison, Ernie Irvan, Dale Jarrett, Ricky Rudd, Kenny Irwin, Elliott Sadler and David Gilliland have competed for the team. The team added a Busch Series program in 2002 and recently earned their first win with driver Stephen Leicht in June 2007. For more information log on to www.RYR.com.
About Newman/Haas/Lanigan Racing…
Newman/Haas/Lanigan Racing LLC (NHLR), owned by actor/race car driver Paul Newman, racing entrepreneur Carl A. Haas and businessman Michael Lanigan is the most successful team competing in the Champ Car World Series and one of the most successful overall competing today. The Lincolnshire, Ill.-based team began their 25th season of Champ Car competition in 2007 and has earned seven championships, 101 wins and 103 pole positions to date. Sebastien Bourdais and Graham Rahal were preceded at the team by Mario and Michael Andretti, Nigel Mansell, Paul Tracy, Christian Fittipaldi, Cristiano da Matta, Bruno Junqueira and Oriol Servia. For more information log onto www.newmanhaaslanigan.com.
QUOTES FROM KEY INDIVIDUALS
Robert Yates, founder of Robert Yates Racing…“This is a wonderful partnership. This gives us a clear vision how to get to the top. It is our goal to continue to build so this team will be better positioned to contend for the championship.”
Doug Yates, president of Roush-Yates Racing Engines…“What they do well complements us and what we do well complements them. This new venture is exciting to me in a lot ways. Incorporating their engineering program will prepare us for future competition. We look forward to sharing much success and getting our teams among the NASCAR elite.”
Carl A. Haas, co-founder of Newman/Haas Racing and co-owner of Newman/Haas/Lanigan Racing…
“I am very proud of the hard work that went into our accomplishments in the Champ Car World Series and hope we can have the same success in NASCAR. We have been looking to add other forms of racing to our Champ Car program and when the opportunity came along to work with Robert Yates Racing, a team that shares the same drive for success that we do, it was too good of an opportunity to pass up. I think that the NASCAR and Champ Car programs can learn something from each other and only enhance the championship level that Robert Yates Racing and Newman/Haas/Lanigan racing have competed at in previous years.”
Paul Newman, co-founder of Newman/Haas Racing and co-owner of Newman/Haas/Lanigan racing…
“We have always been an engineering driven team. We think we have something special to add to the benefit of both. This in no way lessens our commitment to open wheel racing - - - we want to broaden our horizons.”
Michael Lanigan, co-owner of Newman/Haas/Lanigan Racing and Carl A. Haas Motorsports…“The opportunity of joining Robert and Doug Yates is an opportunity of a lifetime. The Yates family has been competing against the best and winning for many years. We look forward to a long and productive association.”
Dan Davis, director, Ford Racing Technology…“I'm very excited at the prospect of putting these two Ford championship-winning teams together. We have had an outstanding relationship with both teams over the years, and we believe their individual strengths compliment each other extremely well. NASCAR Nextel Cup racing is rapidly moving, technology-wise, to engineering areas that Newman/Haas/Lanigan has years of experience with already. And Robert Yates Racing brings years of engine development and race craft in the sport that is invaluable to this operation. Put that expertise together, along with joint ownership that is clearly committed to winning, and we have a Ford program that will be a contender for years to come.”
Edsel B. Ford II, board member, Ford Motor Company…“We're excited about this new partnership between two teams that have already won championships for Ford in motor racing. We've had a long, successful relationship with both of these organizations. Now, going forward, they each will be able to take their specific expertise and help us create a stronger overall Ford program in NASCAR.”
Ricky Rudd, driver of the No. 88 Ford Fusion…“I am so excited for Robert and Doug – Newman/Haas/Lanigan Racing is at the top of their game in the Champ Car World Series. Their history certainly complements the history of Robert Yates Racing.”
David Gilliland, driver of the No. 33 Ford Fusion…“Joining forces with Robert Yates Racing was a dream come true for me. Adding the resources of an organization like Newman/Haas/Lanigan to the mix only makes things better. I look forward to a long and successful career with the Yates/Newman/Haas/Lanigan team.”
Stephen Leicht, driver of the No. 90 Ford Fusion Busch car…“I am just proud to be a part of the Yates Family. And look forward to watching our organization continue to grow.”
Kyle Krisiloff, driver of the No. 14 Lilly/Walgreens Ford Fusion…“I am really honored to be part of this new organization and proud of Carl, Paul and Mike for taking this step to make sure our team has all the tools necessary to win races and contend for championships. It’s really exciting to be a part of Robert Yates Racing because they have always been a leading team in NASCAR and for Ford Racing. I know this new partnership will benefit Lilly and Walgreens as we continue to grow the program.”
Sebastien Bourdais, three-time reigning Champ Car champion and driver of the No. 1 McDonald’s Champ Car for NHLR…“It’s obviously a great opportunity for Newman/Haas/Lanigan Racing to be able to expand and to show our engineering capabilities. NASCAR is a very competitive series and this will be a new challenge for the team.”
From: Kathi Lauterbach / Director of Public Relations // Newman/Haas/Lanigan Racing
GSK is hunkering down for continuing assaults on its number two drug, battered initially by Cleveland Clinic’s Steve Nissen whose meta-analysis showed a 43% increase in heart attack risk for Avandia patients compared to control.
During the company's second quarter conference call, CEO JP Garnier clearly was using the "If you sound like a winner, you are a winner" strategy when it came to discussing Avandia with investors, analysts and media.
"We are still encouraged [about Avandia] because we have seen...a lot of evidence recently," Garnier said of the data GSK has submitted to the agency in advance of a Monday advisory committee fact-gathering meeting. "The evidence is supportive of Avandia's risk/benefit ratio, and of its effect on cardiovascular safety."
GSK is hyping a 400,000-patient epidemiology study of patients on Avandia and Takeda's Actos among other treatments that apparently bodes well for the diabetes drugs.
Glaxo has said that they simply have been unsuccesful in boiling down their message on Avandia to a "7-second soundbyte" which is the reason for the more than 45% decline in new Avandia scripts. " In the US, the media has ... had more of an impact on physician and patient impressions than the data itself," GSK's pharma operations chief David Stout said on the call.
Clearly, the message from GSK is: We stand behind Avandia. Unfortunately for the company, there are some discouraging parallels between their diabetes drug and Warner-Lambert's Rezulin.
Warner-Lambert pioneered the glitazone class, but Rezulin caused liver toxicity that ultimately led to its withdrawal. A recap of the regulatory history suggests some uncomfortable parallels with Avandia and the concerns about cardiovascular safety.
Two months after it got to market in 1997, FDA slapped Rezulin with a stricter warning on its packaging (thanks to 35 post-marketing reports of liver injury). At that point, 500,000 patients were already on the drug. Several "Dear Doctor" letters later, FDA's Endocrine and Metabolic Drugs Advisory Committee reviewed the liver tox issues, and recommended keeping Rezulin on the market, but only for patients not well-controlled on other diabetes drugs. One year later, the drug was taken off the market when reports kept coming in.
For Avandia, the toxicity is different--cardiovascular rather than liver--but the slow motion, repeated regulatory reactions are similar.
Avandia labeling was rewritten to strengthen cardiovascular safety warnings in 2001, and the company issued a "Dear Doctor" letter on the topic at that time. The concerns were raised more directly in the context of the review of Avandia for an indication for use with insulin; that use was ultimately approved in 2003. The Nissen paper now has put the regulatory machinery into fast forward, and an advisory committee will discuss Avandia's fate on Monday.
All of that is uncomfortable enough, but there is another parallel to the end of Rezulin emerging at the worst time for GSK: a Senate Committee is raising concerns that FDA reassigned a medical officer who wanted to put stronger warnings on Avandia.
If that sounds familiar, it should. In early March 2000, FDA senior medical officer Robert Misbin wrote a letter to Rep. Henry Waxman (D-Calif.) expressing frustration over FDA's handling of Misbin's attempts during the previous two months to convince the agency's Center for Drug Evaluation & Research that Rezulin had to be withdrawn from the market. Misbin asserted that FDA officials had stopped him from releasing information related to deaths of Rezulin patients.
One other thing: Misbin was the primary reviewer on Avandia and was taken off of the review several years ago. (Apparently, he's not the whistleblower this time around -- for more speculation on who the whistleblower might be, see the next post.)
All in all, Monday's advisory committee meeting doesn’t look good for Avandia. Even if the medical officers keep quiet, FDA will not be presenting a united front to the committee. That's because the agency is once again going to let its most prominent whistleblower, director for science and medicine in OSE David Graham, make a formal presentation. Graham most recently helped ensure that Merck's Arcoxia died a painful public death before an FDA advisory committee. FDA has apparently concluded that they have to let Graham speak at these meetings rather than wait for him to go to Congress to make his presentations. (Here is our coverage of the Arcoxia debacle.)
On Avandia, Graham has already made his position clear in FDA briefing documents. He argues that the current postmarketing studies (in particular the key RECORD study) can't, statistically, demonstrate a heart attack risk related to Avandia: they're underpowered. In other words, the current scientific evidence is all FDA is going to get to make their decision on the future of GSK's drug. Anyone want to venture a guess at where Graham will stand on Avandia?
And its not like FDA won't let the discussion go into whether the drug needs to be pulled. Quite the opposite. Here is one question posed to the committee: "Does the overall risk-benefit profile of Avandia support its continued marketing in the US (VOTE requested)? If yes, please comment on what FDA should do to maximize the risk-benefit considerations (e.g., limit to certain patients, incorporate a boxed warning….)"
That question means FDA is thinking awfully hard about whether this drug should stay on the market. You could argue that they added the question for political cover in order to leave it on the market, but I'm not buying it. I think they really want to know the experts' opinion.
And what will that opinion be? Nissen himself has said Avandia should remain on pharmacy shelves. NIH's Malozowski told us that he didn’t think FDA would pull it. “They will probably add a warning for a subpopulation of patients and a contraindication for its use with insulin."
I also asked Tom Garvey, a former FDA reviewer who runs his own drug development consulting business, what he thought. He concurs with Malozowski. Sort of.
Rezulin could be pulled off the market with less risk, he argued, because there were two other marketed drugs without Rezulin’s liabilities. Moreover, "the absolute risk found by Nissen is small (if, indeed, it exists) and the benefit conferred by Avandia is not inconsequential, especially in certain types of type II diabetics.”
But then he added, surprisingly: “All of this having been said, I too get the sense that the drug is probably doomed."
In short, as with Rezulin, an FDA advisory committee could recommend keeping Avandia on the market, in a limited way—while, in parallel, the political and historical momentum builds to yank it off. On the scientific front, the data isn’t clear. Nissen's meta-analysis has come under intense fire, but his results were confirmed by FDA's own meta-analysis, and they had access to a much larger data set. Meanwhile, GSK's RECORD study has been inconclusive on the heart attack risk question.
But the political front will evolve in its own way. And if history really is rhyming, if not precisely repeating itself, FDA will have a hard time keeping Avandia on the market.
Previously it was revealed that the former Deputy Director of the Division of Drug Risk Evaluation in the Office of Surveillance and Epidemiology (OSE) Rosemary Johann-Liang, who recently left the agency, had been verbally reprimanded for recommending that a black box for congestive heart failure be placed on Avandia. Now Baucus and Grassley allege a second reviewer was taken off the review.
"During a recent interview with Finance Committee staff," their letter says, "a senior medical officer in the Office of New Drugs (OND), who at one point was the primary reviewer for Avandia, told staff investigators that s/he was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia. Since 2005, the senior medical officer believed that there was enough evidence to support a black box warning regarding the risk of CHF."
Next, we talked with former Avandia primary reviewer Saul Malozowski, now a senior advisor on endocrine physiology in NIH's National Institute of Diabetes and Digestive and Kidney Diseases, who left FDA in 2001. "Nobody under my direct supervision was ever removed from any task in either Avandia or other drugs," he said via email. "I hope you have access to my review of this drug where I underscored the potential pitfalls in the documentation provided and the dangers that patients with cardiac condition could encounter. I also was concerned about the weight gain." So he wasn’t the whistleblower either.
Raleigh Parks Bond
City Council at-large first choice (voters get two choices)
Complete results here. Next week we will release more results from this survey concerning the future of the Dorothea Dix property.
EDMONTON, AB – The last half of the season begins this weekend for race teams of the Northern Provincial Pipelines Ltd. Late Model Series. It’s also the only race of the season which starts in the afternoon and finishes in the early evening hours. “Reacting to changing track conditions will be crucial for race teams this Saturday,” indicates N.P.P. Series announcer Gord Craig, “drivers that adapt the quickest will be at the front when the checkered flag waves.” Adding to the pressure is the fact that this will be the final race of the season that all drivers in the points chase have a mathematical chance at winning the 2007 N.P.P. Series Championship. Defending Series Champion Dwight Kennedy (Edson, Alberta) knows he’s got to shine this weekend. “We had a tough weekend in Southern Alberta with a flat tire last Friday and a transmission going Saturday. We were leading both races when this happened.” Kennedy, who now sits fifth in the standings, had won two of three race events before the southern Alberta swing. Rookie driver Curtis Moore is looking forward to the race in Rimbey and the run for rookie of the year honors. “Time is running out for us to get back into the top ten,” says the Sherwood Park, Alberta driver, “we have had a little bit of problems here and there and that has allowed Rod Wilde and Paul Grundberg to sneak a head of us in the rookie race. We’ve got the car to do it and a good set up crew we intend to be there at the end.”
POINT LEADER BEAULIEU TO MISS RIMBEY RACE
EDMONTON, AB – The current N.P.P. Late Model Series point leader will not be racing at Central Alberta Raceway in Rimbey, Alberta this weekend. However, the All Weather Windows sponsored #46 which Jason Beaulieu normally drives will be on the track. “It was a tough decision,” indicates Beaulieu, “but I am racing my first ever dirt Modified Nationals event in Elma Washington this weekend. Brad Purdey will be filling in for me.” Purdey is an accomplished dirt racer from Port McNeill, BC but a little known driver to other N.P.P. Series race teams. “I wouldn’t put just anyone in my car,” says Beaulieu, “I don’t consider this a risk to my point lead at all. In fact it wouldn’t surprise me if he finished in the top five on Saturday night." Purdey is not taking this weekend’s race lightly. “Jason’s basically handed me the keys to his race car and the point lead and is saying go have some fun in my place. I know I will."