2010 FDA Decisions to Watch
By Brian Orelli
December 31, 2009 | Comments (7)
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Being a drug-company shareholder before the Food and Drug Administration makes decisions about those companies' drugs can be scary, but it can also lead to spectacular returns. If you have the guts to buy, here are a few drug companies hoping for those kinds of returns next year.
Exubera 2.0?
The biggest hurdle for Mannkind's (Nasdaq: MNKD) inhaled insulin, Afresa, probably won't be getting past the FDA near its PDUFA date of Jan 16. Insulin is a pretty basic drug, and Afresa seems to have a better profile than other options; unlike current offerings, it mimics natural insulin spikes seen in non-diabetics after they eat.
Instead, Mannkind's biggest obstacle will be on the marketing front, keeping from following in the footsteps of Pfizer (NYSE: PFE) and Nektar Therapeutics' inhaled insulin, Exubera. Not too many doctors were exuberant about Exubera; the drug/device registered a measly $12 million in sales during its first nine months on the market before Pfizer gave up and handed the drug back to Nektar.
Afresa is smaller than Exubera, and Mannkind is working on an even smaller device whose size will be a selling point. Ultimately, though, it will come down to whether doctors are interested in trying out a new product when the current offerings work well enough and whether patients request a needle-free alternative.
Mannkind may be able to get some traction, but I expect a slow uptake.
678 fewer injections
Amylin Pharmaceuticals (Nasdaq: AMLN) and Eli Lilly's (NYSE: LLY) Byetta is a great drug. It controls diabetics' glucose well, keeping them from having to go onto insulin. It even has an added benefit of causing weight loss.
The only problem is that the drug has to be injected twice a day. That's fairly burdensome compared with popping pills like Merck's (NYSE: MRK) Januvia, and sales have suffered, reaching only $679 million last year and falling slightly through the first three quarters of this year as some worries of pancreatitis have arisen.
The duo's solution is a once-weekly formula of Byetta using Alkermes' extended-release technology. The decreased injections should increase sales, but first they'll have to get past the FDA in March. The efficacy data looked good -- it beat Januvia and Takeda's Actos in head-to-head trials -- but the FDA may be leery of an approval because of the side-effect issue. Novo Nordisk's once-daily liraglutide, which is in the same class, has been waiting for an FDA approval since last March.
Once-weekly Byetta should be approved, but don't expect a speedy FDA decision.
2 years in the making
After the FDA's somewhat shocking denial of Dendreon's (Nasdaq: DNDN) prostate-cancer treatment Provenge in May of 2007, the company will have another date with the FDA on May 1 of next year.
The data the FDA previously requested turned out positive, so an approval seems more likely than not. The biggest risk is that the FDA finds something wrong on the manufacturing side of things. The treatment takes immune cells from a patient and trains them to become cancer-fighting machines before putting them back into the patient. The FDA needs to be certain that Dendreon can accurately repeat the process.
Here's hoping that Dendreon doesn't end up sending out another mayday to investors on May Day.
Potential obesity-drug approvals: size XXXL
2010 could see the FDA weighing in on three obesity drugs. Arena Pharmaceuticals and VIVUS (Nasdaq: VVUS) both submitted their applications to the FDA this month, and Orexigen Therapeutics expects to file in the first half of next year.
Of the three, VIVUS' Qnexa probably has the best weight-loss data, but Arena's Lorcaserin may have the best safety profile. The latter is important, since diet and exercise work pretty well as treatments for obesity and the agency is likely to be very safety conscious. An approval for any or all of the drugs isn't a slam dunk, but considering the large market, the risk could be worth the reward.
Usual disclosures apply
Keep in mind that the FDA sets up PDUFA dates, but they're not a deadline that the agency is required to meet. Trying to day-trade around the PDUFA date can be dangerous to your portfolio. A much better strategy is to think longer-term. Find a company you like at a price you can live with, and don't worry about any delays the FDA may throw at your investment.
Any other FDA decisions you're looking forward to in the new year? Let us know in the comment box below.
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Report this Comment On December 31, 2009, at 2:52 PM, norman1066 wrote: Thanks for an interesting article,
Afresa will have no trouble outselling Exubera. Pfizer's drug was more costly than injectable insulin yet was neither more effective nor safer. On the other hand Afresa works just as well, doesn't cause weight gain, and is measurably SAFER.
This last point is important as it will potentially allow physicians to prescribe Afresa earlier in type 2 diabetics disease progression. It is possible that Afresa could become the first line therapy (not in 2010 but possibly in a couple of years). If that occurs Mannkind will have a mega drug on its hands.
The big hurdle for Mannkind appears to be getting a big pharma partner for the drug as MNKD isn't your typical bio start-up eager to take any bone thrown its way. With Al Mann's deep pockets they have chosen to blaze their own trail right through to FDA approval. It should be entertaining to see what deal they eventually strike and how the street perceives it.
Report this Comment On December 31, 2009, at 3:33 PM, goyocafe wrote: "...when the current offerings work well enough..."
Comments like this only demonstrate a lack of appreciation for diabetes treatments that exist today. If this were true, why then is there such a huge untapped market for new treatments for this terrifying disease?
Report this Comment On December 31, 2009, at 4:34 PM, pharmagenius wrote: Why no mention of GENEREX's ORAL-LYN? Their oral insulin product is coming up for FDA approval in 2010. Its currently in Phase III trials in Canada and the U.S. They already have FDA approval for emergency use and ORAL-LYN is already in use in several countries.
Report this Comment On December 31, 2009, at 5:03 PM, JPG101 wrote: Generex doesn't actually sell insulin if you look at their balance sheet. They are in trouble in India. Management pays itself very well for a small company with no partnerships or institutional buy in.
I think this is a scam company that will go broke with time. The individual small investors will get seriously burnt with this company.
Report this Comment On January 01, 2010, at 5:03 PM, AlexKalman wrote: FOOL, MISSES PHASE III FOR SOME CANCERS?
Next Dendreon? Novelos' CEO Eyeing "Revolutionary" Phase III Results
Written by M.E.Garza
Wednesday, 16 December 2009 00:00
"What's interesting about Novelos is that we're in a Pivotal Phase III trial for lung cancer under both SPA and Fast Track for our NOV-002 lead compound," explains Novelos Therapeutics' (OTC: NVLT) Chief Executive Officer, Harry S. Palmin.
The study, a randomized, open-label, Phase 3 Trial of NOV-002 in Combination with Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin alone for the treatment of advanced non-small cell lung cancer is being conducted under the FDA's Special Protocol Assessment. It blinds Novelos from seeing any results as it progresses.
In other words, there is no interim analysis. There is only "one look" and that look occurs once 725 deaths take place during the trial.
"These patients with a median survival of eight to ten months unfortunately die pretty quickly," explains Novelos Therapeutics' Chief Executive Officer, Harry S. Palmin. "One year survival, which is another way to look at this, is just about 40%."
The pivotal study itself began more than three years ago, in November of 2006. By March of 2008, the enrollment target of patients had been reached and now, over a year and a half later, the 725th event has not yet occurred.
It's become pretty obvious, even to the most casual observer, that the patients involved in the trial are living longer than expected and that, in fact, is one of the reasons why Wall Street has begun to take more interest in the company and the study. Originally, most observers, including insiders at the company, expected that the trial might reach a conclusion some time during the middle of this year.
"It's a very unique value proposition," says Palmin. "If you think of Avastin, Roche's drug, it's the only drug in non-small cell lung cancer, first line treatment that showed a survival advantage. They showed a two month survival advantage, 12.3 months versus 10.3, but the drug has severe toxicities associated with it on top of the chemotherapy toxicities and it's very expensive. It's also only available to very few lung cancer patients because the histology it works for is non-squamous.
"The point that I'm trying to make is that given our current statistical projections, because our trial is going late, if we assume that the control group does in fact what it's supposed to, around a ten month median survival, and there's historical data on some four-thousand patients with advanced stage lung cancer that have taken our type of chemotherapy (paclitaxel/carboplatin [standard of care in the U.S.]), then we should be on track to achieve or possibly even exceed our possible twelve and a half month median survival target.
"By way of background, we started the pivotal Phase III on lung cancer on the back of three Phase II's," explains Palmin. "Same patient population and in two of the trials that were done in Russia, we saw dramatic survival advantages, better anti-tumor effects and in the United States, we saw doubling response rates and better toleration of chemotherapy. So there are three lung cancer trials that were the basis for the pivotal Phase III. We, of course, have applicability to other indications because we're not tumor specific and we're not chemotherapy specific."
That is an important point that has not gone unnoticed. This year, Perdue Pharma has invested over $19 million dollars in Novelos. The company itself, since going public over 5 years ago, has raised over $70 million dollars.
"We had good data out of Russia in non-small cell lung and it is the number one cancer killer, currently; late stage lung cancer," says Palmin. "There are north of two-hundred thousand new patients each year and more than one hundred and sixty thousand deaths and it's a huge market. Just lung cancer is north of a $3.5 billion dollar market.
"Since we have applicability, really, to all solid tumors, in Russia the drug is already approved for general use with chemotherapy. Here in the United States, we've had two positive Phase II results in ovarian and breast cancer. Channel 7 in Miami recently profiled a breast cancer patient that was in our Phase II breast cancer trial and went into complete remission. No signs of cancer. That's based on publicly available information where we've had forty percent of the patients have had no sign of their cancer after treatment of chemo and our drug.
"In addition, the patients that take our drug with the chemotherapy have a much better quality of life while under that treatment, versus being on chemo alone. Plus, very importantly, there is the efficacy improvement. That makes this a very different approach to the treatment of cancer."
Report this Comment On January 03, 2010, at 9:56 PM, larssral wrote: Chelsea Therapeutics (CHTP) is wrapping a phase three trial for Droxidopa (indication for orthostatic hypotension) which it successfully petitioned changes to the study's endpoint.
They were asked to conduct an additional trial, which should put them in place to submit an NDA by the end of 2010, if not sooner
Wednesday, January 6, 2010
Friday, December 18, 2009
A $5 footlong success story
Subway's $5 sandwich, the brainchild of an obscure Miami franchisee, is the fast-food success story of the recession.
[Related content: savings, save money, food prices, frugal, food]
By BusinessWeek
Stuart Frankel isn't what you'd call a power player in the world of franchising.
Can Subway challenge McDonald's?
Five years ago, he owned two small Subway sandwich shops at either end of Miami's Jackson Memorial Hospital. After noticing that sales sagged on weekends, he came up with an idea: He would offer every footlong sandwich (the chain also sells 6-inch versions) on Saturday and Sunday for $5, about a buck less than the usual price.
"I like round numbers," says Frankel, a brusque New Yorker who moved to Miami in 1972 and owned a drugstore before opening his first Subway outlet in 1988.
Customers liked his round number, too. Instead of dealing with idle employees and weak sales, Frankel suddenly had lines out the door. Sales rose by double digits. Nobody, least of all Frankel, knew it at the time, but he had stumbled on a concept that has unexpectedly morphed from a short-term gimmick into a national phenomenon that has turbocharged Subway's performance.
"There are only a few times when a chain has been able to scramble up the whole industry, and this is one of them," says Jeffrey T. Davis, the president of restaurant consultancy Sandelman & Associates. "It's huge."
In fact, the $3.8 billion in sales generated nationwide by the $5 footlong alone placed it among the top 10 fast-food brands in the U.S. for the year ended in August, according to NPD Group. That puts the $5 menu's success just a notch behind Yum Brands' (YUM, news, msgs) KFC and ahead of Arby's (WEN, news, msgs) and Domino's Pizza (DPZ, news, msgs). It helped privately held Subway, of Milford, Conn., lift U.S. sales 17% last year at a time when most restaurant chains, save for industry leader McDonald's (MCD, news, msgs), struggled.
Actually, make that soon-to-be-former industry leader McDonald's. Subway's low-cost franchising model and mainstream appeal have allowed it to add 9,500 locations in the past five years, for a total of about 32,000 outlets. At its current growth rate of 40 new stores a week, Subway is poised to surpass McDonald's in worldwide locations sometime early next year.
Measured by total sales, McDonald's $30 billion still dwarfs Subway's $9.6 billion, although Subway has now supplanted both Wendy's and Burger King (BKC, news, msgs) in market share.
'A life of its own'
Frankel's $5 footlong idea illustrates how a huge company can wake up and eventually seize on a good idea that's not generated at headquarters. Frankel, along with two other local managers in economically ravaged South Florida, ceaselessly championed the idea to Subway's corporate leadership amid widespread skepticism. Once it was approved, Subway's marketing team quickly generated a memorable campaign that firmly established the $5 footlong nationwide. The promotion's success spawned imitators and created an unprecedented demand for staple ingredients such as turkey, ham and tuna.
"The whole thing took on a life of its own," says Jeff Moody, the CEO of Subway's franchise-owned advertising arm, the Subway Franchisee Advertising Fund Trust.
The fact that a sandwich, the quintessential American food, has grabbed the spotlight right now comes as no surprise to some. Its appeal goes beyond the low sticker price -- you can share a footlong with a co-worker or a friend (something that's not quite as easy with a Big Mac).
"People are not eating out as much anymore, so anything that brings people together through food is much more compelling nowadays," says Michelle Barry of the Hartman Group, a Seattle consultancy that employs anthropologists and sociologists to ferret out consumer perceptions for such companies as Kraft Foods (KFT, news, msgs) and Wal-Mart Stores (WMT, news, msgs).
For Frankel, the biggest surprise from his $5 promotion was that his profit margins didn't decline. Many promotions are so-called loss leaders designed to draw customers in the hope they'll buy higher-margin items alongside the featured specials. That's one reason most offers have a time limit. Frankel's food costs did rise as a percentage of sales, but that was offset by the overall boost in volume and the increased productivity of his employees, who had less down time. Even after adding two new staffers, Frankel made money on each $5 sandwich.
Frankel kept the weekend promotion going for more than a year. At the same time, Subway's top brass was growing tired of a national ad campaign that featured spokesman Jared Fogle, who had lost 245 pounds almost a decade earlier by eating Subway 6-inch subs for lunch and dinner. Company insiders envied the success of McDonald's dollar menu and wanted a "value" offering of their own.
In September 2007, Steve Sager, a Subway development agent who oversaw about 225 franchises across South Florida, heard about the success of Frankel's $5 deal. He decided to try it in a troubled Fort Lauderdale, Fla., outlet on Commercial Boulevard, a gritty thoroughfare dotted with strip malls. On the first day of the promotion, the store nearly ran out of bread and meat. Sales doubled.
Video: Subway's recession-friendly fare
Sager called Subway co-founder Fred DeLuca, who lives in the vicinity, and excitedly shared the news. An intrigued DeLuca came by the shop and, Sager says, "saw the potential instantly." (DeLuca declined to comment.) Charlie Serabian, the owner of 50South Florida Subways, decided to launch the promotion in some of his stores. To advertise, he slapped crude homemade signs in the windows that spelled out "ALL FOOTLONGS $5." DeLuca joked that they looked like ransom letters. It didn't matter: Sales rose as much as 35%. Some locations, such as those housed inside Wal-Mart stores, did even better.
Moody, the marketing chief, hopped a flight to Fort Lauderdale a month later. He arrived at one store at 11 a.m. to find a line out the door. Frankel and Sager, who accompanied him, jumped behind the counter to help make sandwiches, while Moody talked to customers. Most were buying footlongs, and some were saving half for later.
Clearly, the South Florida crew was onto something. The question was whether it would resonate elsewhere. "Unless it was in your store, you were skeptical," Moody says. At a meeting of the franchisee marketing board that fall, Frankel presented his idea. Many owners thought the promotion would send food and labor costs soaring, erasing any hope of profits. A motion to roll it out nationally failed.
Annoying jingle
But others picked up on Frankel's idea and tried it in locations ranging from Washington to Chicago. Right before Christmas 2008, the board voted again, and the motion passed. (Franchisees still had the option to not do it.)
Moody pushed ahead with a national campaign, despite having no market research to back up the idea. "It violated all our normal processes," says Moody, whose annual ad budget is around $500 million.
Subway soon brought in its ad agency, MMB of Boston. "Let's not overcomplicate this," MMB managing partner Chad Caufield recalls thinking. The idea was to use hand gestures and an irritatingly addictive jingle to convey both the price (five fingers) and the product (hands spread about a foot apart). MMB also shot on a soundstage, giving the commercial a stylized, campy look. "We wanted to create the feeling that this was a movement taking hold," Caufield says.
The campaign was launched on March 23, 2008 -- the same month that Bear Stearns collapsed into the arms of JPMorgan Chase (JPM, news, msgs). "The timing could not have been better," says Dennis Lombardi, the executive vice president at restaurant consultancy WD Partners. Over the first two weeks, franchisees reported that sales shot up 25% on average. Within weeks, 3,600 videos of people performing the jingle appeared on YouTube. Fogle, attending the NCAA Final Four college basketball tournament soon after the launch, was serenaded with the song by students. The $5 footlong was mentioned on ESPN, "The Tonight Show" and celebrity gossip site TMZ. The North Carolina State Fair even held a $5 Footlong Song Challenge -- an "American Idol"-style event for the 4-H crowd.
The franchisee marketing board quickly voted to extend the four-week promotion to seven weeks. When that ended, Subway kept it going but limited the number of $5 sandwiches to just eight, removing items with high ingredient costs, such as the Chicken & Bacon Ranch sandwich.
Video: Subway's recession-friendly fare
Suddenly, Subway needed 50% more food supplies. Bread shortages became a problem, as the ratio of 6-inch sandwiches to footlong orders, normally 2-to-1, flipped. Subway's franchise-owned Independent Purchasing Cooperative, or IPC, had to scramble to find new sources of bread. Even mundane items, such as plastic sandwich bags from China, nearly ran out.
"I was in a panic," recalls IPC Chief Executive Jan Risi, who furiously worked the phones, cajoling her network of suppliers to run extra shifts.
Even cheaper
Soon, copycat offers emerged. Boston Market offered 11 meals for $5 each, while Domino's sold sandwiches for $4.99, and KFC launched $5 combo meals. T.G.I. Friday's began selling $5 sandwiches.
"Five dollars is the magic number now," restaurant consultant Malcolm Knapp says. "It's become a price point that consumers respond to," says Judy Cantrell, Boston Market's chief brand officer.
The question now is when the campaign will run out of steam. MMB's Caufield concedes the issue keeps him up at night: "Are we riding this pony too long?" Tony Pace, a senior executive who works with Subway's marketing arm, replies bluntly: "If you had a brand that represented nearly $4 billion in sales, would you plan an exit strategy for it?"
Can Subway challenge McDonald's?
Pace says the footlong will remain "as long as it makes good economic sense," so a decline in footlong sales could force price increases or limits, such as $5 after 4 p.m. only. (Serabian has gone the other way as the South Florida economy has worsened, offering footlongs for $4 in his stores.) There are also concerns that Subway's focus on the footlong could distract it from new growth areas, such as a planned push into breakfast items or international expansion. (Save for some tests in Australia and Canada, the $5 footlong hasn't gone beyond the U.S.)
Meanwhile, Frankel has moved on to a new idea. Now he's pushing for Subway loyalty cards that let purchasers accrue points toward free sandwiches. Driving down Interstate 95 on a cloudy autumn day, Frankel chronicles the frustrations he's had convincing DeLuca and others that this could be a hit. Maybe now that Frankel is the father of the $5 Footlong, they'll listen.
This article was reported by Matthew Boyle for BusinessWeek.
Comment
I eat $5 footlongs once or twice a week, and enjoy them.
[Related content: savings, save money, food prices, frugal, food]
By BusinessWeek
Stuart Frankel isn't what you'd call a power player in the world of franchising.
Can Subway challenge McDonald's?
Five years ago, he owned two small Subway sandwich shops at either end of Miami's Jackson Memorial Hospital. After noticing that sales sagged on weekends, he came up with an idea: He would offer every footlong sandwich (the chain also sells 6-inch versions) on Saturday and Sunday for $5, about a buck less than the usual price.
"I like round numbers," says Frankel, a brusque New Yorker who moved to Miami in 1972 and owned a drugstore before opening his first Subway outlet in 1988.
Customers liked his round number, too. Instead of dealing with idle employees and weak sales, Frankel suddenly had lines out the door. Sales rose by double digits. Nobody, least of all Frankel, knew it at the time, but he had stumbled on a concept that has unexpectedly morphed from a short-term gimmick into a national phenomenon that has turbocharged Subway's performance.
"There are only a few times when a chain has been able to scramble up the whole industry, and this is one of them," says Jeffrey T. Davis, the president of restaurant consultancy Sandelman & Associates. "It's huge."
In fact, the $3.8 billion in sales generated nationwide by the $5 footlong alone placed it among the top 10 fast-food brands in the U.S. for the year ended in August, according to NPD Group. That puts the $5 menu's success just a notch behind Yum Brands' (YUM, news, msgs) KFC and ahead of Arby's (WEN, news, msgs) and Domino's Pizza (DPZ, news, msgs). It helped privately held Subway, of Milford, Conn., lift U.S. sales 17% last year at a time when most restaurant chains, save for industry leader McDonald's (MCD, news, msgs), struggled.
Actually, make that soon-to-be-former industry leader McDonald's. Subway's low-cost franchising model and mainstream appeal have allowed it to add 9,500 locations in the past five years, for a total of about 32,000 outlets. At its current growth rate of 40 new stores a week, Subway is poised to surpass McDonald's in worldwide locations sometime early next year.
Measured by total sales, McDonald's $30 billion still dwarfs Subway's $9.6 billion, although Subway has now supplanted both Wendy's and Burger King (BKC, news, msgs) in market share.
'A life of its own'
Frankel's $5 footlong idea illustrates how a huge company can wake up and eventually seize on a good idea that's not generated at headquarters. Frankel, along with two other local managers in economically ravaged South Florida, ceaselessly championed the idea to Subway's corporate leadership amid widespread skepticism. Once it was approved, Subway's marketing team quickly generated a memorable campaign that firmly established the $5 footlong nationwide. The promotion's success spawned imitators and created an unprecedented demand for staple ingredients such as turkey, ham and tuna.
"The whole thing took on a life of its own," says Jeff Moody, the CEO of Subway's franchise-owned advertising arm, the Subway Franchisee Advertising Fund Trust.
The fact that a sandwich, the quintessential American food, has grabbed the spotlight right now comes as no surprise to some. Its appeal goes beyond the low sticker price -- you can share a footlong with a co-worker or a friend (something that's not quite as easy with a Big Mac).
"People are not eating out as much anymore, so anything that brings people together through food is much more compelling nowadays," says Michelle Barry of the Hartman Group, a Seattle consultancy that employs anthropologists and sociologists to ferret out consumer perceptions for such companies as Kraft Foods (KFT, news, msgs) and Wal-Mart Stores (WMT, news, msgs).
For Frankel, the biggest surprise from his $5 promotion was that his profit margins didn't decline. Many promotions are so-called loss leaders designed to draw customers in the hope they'll buy higher-margin items alongside the featured specials. That's one reason most offers have a time limit. Frankel's food costs did rise as a percentage of sales, but that was offset by the overall boost in volume and the increased productivity of his employees, who had less down time. Even after adding two new staffers, Frankel made money on each $5 sandwich.
Frankel kept the weekend promotion going for more than a year. At the same time, Subway's top brass was growing tired of a national ad campaign that featured spokesman Jared Fogle, who had lost 245 pounds almost a decade earlier by eating Subway 6-inch subs for lunch and dinner. Company insiders envied the success of McDonald's dollar menu and wanted a "value" offering of their own.
In September 2007, Steve Sager, a Subway development agent who oversaw about 225 franchises across South Florida, heard about the success of Frankel's $5 deal. He decided to try it in a troubled Fort Lauderdale, Fla., outlet on Commercial Boulevard, a gritty thoroughfare dotted with strip malls. On the first day of the promotion, the store nearly ran out of bread and meat. Sales doubled.
Video: Subway's recession-friendly fare
Sager called Subway co-founder Fred DeLuca, who lives in the vicinity, and excitedly shared the news. An intrigued DeLuca came by the shop and, Sager says, "saw the potential instantly." (DeLuca declined to comment.) Charlie Serabian, the owner of 50South Florida Subways, decided to launch the promotion in some of his stores. To advertise, he slapped crude homemade signs in the windows that spelled out "ALL FOOTLONGS $5." DeLuca joked that they looked like ransom letters. It didn't matter: Sales rose as much as 35%. Some locations, such as those housed inside Wal-Mart stores, did even better.
Moody, the marketing chief, hopped a flight to Fort Lauderdale a month later. He arrived at one store at 11 a.m. to find a line out the door. Frankel and Sager, who accompanied him, jumped behind the counter to help make sandwiches, while Moody talked to customers. Most were buying footlongs, and some were saving half for later.
Clearly, the South Florida crew was onto something. The question was whether it would resonate elsewhere. "Unless it was in your store, you were skeptical," Moody says. At a meeting of the franchisee marketing board that fall, Frankel presented his idea. Many owners thought the promotion would send food and labor costs soaring, erasing any hope of profits. A motion to roll it out nationally failed.
Annoying jingle
But others picked up on Frankel's idea and tried it in locations ranging from Washington to Chicago. Right before Christmas 2008, the board voted again, and the motion passed. (Franchisees still had the option to not do it.)
Moody pushed ahead with a national campaign, despite having no market research to back up the idea. "It violated all our normal processes," says Moody, whose annual ad budget is around $500 million.
Subway soon brought in its ad agency, MMB of Boston. "Let's not overcomplicate this," MMB managing partner Chad Caufield recalls thinking. The idea was to use hand gestures and an irritatingly addictive jingle to convey both the price (five fingers) and the product (hands spread about a foot apart). MMB also shot on a soundstage, giving the commercial a stylized, campy look. "We wanted to create the feeling that this was a movement taking hold," Caufield says.
The campaign was launched on March 23, 2008 -- the same month that Bear Stearns collapsed into the arms of JPMorgan Chase (JPM, news, msgs). "The timing could not have been better," says Dennis Lombardi, the executive vice president at restaurant consultancy WD Partners. Over the first two weeks, franchisees reported that sales shot up 25% on average. Within weeks, 3,600 videos of people performing the jingle appeared on YouTube. Fogle, attending the NCAA Final Four college basketball tournament soon after the launch, was serenaded with the song by students. The $5 footlong was mentioned on ESPN, "The Tonight Show" and celebrity gossip site TMZ. The North Carolina State Fair even held a $5 Footlong Song Challenge -- an "American Idol"-style event for the 4-H crowd.
The franchisee marketing board quickly voted to extend the four-week promotion to seven weeks. When that ended, Subway kept it going but limited the number of $5 sandwiches to just eight, removing items with high ingredient costs, such as the Chicken & Bacon Ranch sandwich.
Video: Subway's recession-friendly fare
Suddenly, Subway needed 50% more food supplies. Bread shortages became a problem, as the ratio of 6-inch sandwiches to footlong orders, normally 2-to-1, flipped. Subway's franchise-owned Independent Purchasing Cooperative, or IPC, had to scramble to find new sources of bread. Even mundane items, such as plastic sandwich bags from China, nearly ran out.
"I was in a panic," recalls IPC Chief Executive Jan Risi, who furiously worked the phones, cajoling her network of suppliers to run extra shifts.
Even cheaper
Soon, copycat offers emerged. Boston Market offered 11 meals for $5 each, while Domino's sold sandwiches for $4.99, and KFC launched $5 combo meals. T.G.I. Friday's began selling $5 sandwiches.
"Five dollars is the magic number now," restaurant consultant Malcolm Knapp says. "It's become a price point that consumers respond to," says Judy Cantrell, Boston Market's chief brand officer.
The question now is when the campaign will run out of steam. MMB's Caufield concedes the issue keeps him up at night: "Are we riding this pony too long?" Tony Pace, a senior executive who works with Subway's marketing arm, replies bluntly: "If you had a brand that represented nearly $4 billion in sales, would you plan an exit strategy for it?"
Can Subway challenge McDonald's?
Pace says the footlong will remain "as long as it makes good economic sense," so a decline in footlong sales could force price increases or limits, such as $5 after 4 p.m. only. (Serabian has gone the other way as the South Florida economy has worsened, offering footlongs for $4 in his stores.) There are also concerns that Subway's focus on the footlong could distract it from new growth areas, such as a planned push into breakfast items or international expansion. (Save for some tests in Australia and Canada, the $5 footlong hasn't gone beyond the U.S.)
Meanwhile, Frankel has moved on to a new idea. Now he's pushing for Subway loyalty cards that let purchasers accrue points toward free sandwiches. Driving down Interstate 95 on a cloudy autumn day, Frankel chronicles the frustrations he's had convincing DeLuca and others that this could be a hit. Maybe now that Frankel is the father of the $5 Footlong, they'll listen.
This article was reported by Matthew Boyle for BusinessWeek.
Comment
I eat $5 footlongs once or twice a week, and enjoy them.
Wednesday, December 16, 2009
Nano Cancer Cures?
December 15, 2009 9:15 PM PST
Can we diagnose and destroy cancer in one sitting?
by Elizabeth Armstrong Moore Font size Print E-mail Share 1 comment Yahoo!
Let's say you find a lump somewhere and decide to go in for an exam. And let's say there was a little box to check that allows you to get a shot that targets and kills cancerous cells right then and there, no surgery, no waiting, and possibly no radiation or chemo therapy down the road. Would you check the box?
These nanoshells target tumors in the lungs and, upon excitation with near-infrared light, destroy only the cancerous tissue.
(Credit: The Alliance for NanoHealth)
Since time matters when it comes to cancer, the creation of a single nanoparticle--traceable in real time via MRI--that tags and zaps cancer cells all in one procedure has a team of researchers raising their eyebrows in hopeful arches.
"Some of the most essential questions in nanomedicine today are about biodistribution--where particles go inside the body and how they get there," says Naomi Halas, a nanomedicine pioneer at Rice University in Houstin, Texas, whose findings have just been published in Advanced Functional Materials. "Noninvasive tests for biodistribution will be enormously useful on the path to FDA approval, and this technique--adding MRI functionality to the particle you're testing and using for therapy--is a very promising way of doing this."
The all-in-one particles are modeled on nanoshells, a cancer treatment Halas invented in the '90s that are now in human clinical trials. The shells harvest laser light that would typically pass through the body harmlessly and convert that light into heat that destroys cancerous cells.
Halas, who designed the new particle with assistant professor Amit Joshi of Baylor College of Medicine's Division of Molecular Imaging, added a fluorescent dye to the nanoshell so that it glows when hit by near-infrared (NIR) light.
Tracking the nanoparticles by their fluorescence, the team confirmed that the particles do indeed target cancer cells and kill them with heat. Even though human clinical trials are probably a few years out, the hope is that eventually patients will be able to get a shot with a cocktail of these nanoparticles and antibodies tailored to specific cancer types, and then sit back and watch the war on tumors in real time via MRI and/or NIR imaging.
Halas adds that the team has been careful to choose components that are either already approved for medical use or are already in clinical trials: "We're putting together components that all have good, proven track records."
Can we diagnose and destroy cancer in one sitting?
by Elizabeth Armstrong Moore Font size Print E-mail Share 1 comment Yahoo!
Let's say you find a lump somewhere and decide to go in for an exam. And let's say there was a little box to check that allows you to get a shot that targets and kills cancerous cells right then and there, no surgery, no waiting, and possibly no radiation or chemo therapy down the road. Would you check the box?
These nanoshells target tumors in the lungs and, upon excitation with near-infrared light, destroy only the cancerous tissue.
(Credit: The Alliance for NanoHealth)
Since time matters when it comes to cancer, the creation of a single nanoparticle--traceable in real time via MRI--that tags and zaps cancer cells all in one procedure has a team of researchers raising their eyebrows in hopeful arches.
"Some of the most essential questions in nanomedicine today are about biodistribution--where particles go inside the body and how they get there," says Naomi Halas, a nanomedicine pioneer at Rice University in Houstin, Texas, whose findings have just been published in Advanced Functional Materials. "Noninvasive tests for biodistribution will be enormously useful on the path to FDA approval, and this technique--adding MRI functionality to the particle you're testing and using for therapy--is a very promising way of doing this."
The all-in-one particles are modeled on nanoshells, a cancer treatment Halas invented in the '90s that are now in human clinical trials. The shells harvest laser light that would typically pass through the body harmlessly and convert that light into heat that destroys cancerous cells.
Halas, who designed the new particle with assistant professor Amit Joshi of Baylor College of Medicine's Division of Molecular Imaging, added a fluorescent dye to the nanoshell so that it glows when hit by near-infrared (NIR) light.
Tracking the nanoparticles by their fluorescence, the team confirmed that the particles do indeed target cancer cells and kill them with heat. Even though human clinical trials are probably a few years out, the hope is that eventually patients will be able to get a shot with a cocktail of these nanoparticles and antibodies tailored to specific cancer types, and then sit back and watch the war on tumors in real time via MRI and/or NIR imaging.
Halas adds that the team has been careful to choose components that are either already approved for medical use or are already in clinical trials: "We're putting together components that all have good, proven track records."
Tuesday, December 15, 2009
Volunteering Computers for Science - Wall Street Journal
OCTOBER 20, 2009
Users Make Their Home PCs Available to Chase Medical By JEREMY SINGER-VINE
The next cure for a major disease is as likely to be discovered on a computer as on a laboratory bench—and scientists are enlisting ordinary citizens to volunteer to help crunch the data.
Advances in computer science have enabled medical researchers to test how proteins fold, genes interact and pandemics spread in complex digital simulations of natural environments. As these simulations become more intensive and widely used, however, computers at academic institutions and other research facilities can't keep up with the demand for medical processing power.
Indian border security guards, who regularly contract malaria, are required to carry repellents and masks. Instead, scientists are tapping into a vast network that allows the research to be parceled out in tiny workloads that can be performed on anyone's household computer when it's not otherwise being used. So far, hundreds of thousands of people in countries around the world have volunteered their computers' processing power to help advance the cause of medical research.
Here's how it works: Volunteers download an application onto their home computer that links them into a network that includes other citizen volunteers and research scientists. The network assigns each computer a small bit of a project's puzzle to solve. The process, which continues as long as the computer is turned on but idle, typically takes several hours, but can vary depending on the project and the individual computer's power. When complete, the results are automatically sent back to the network's server.
In 2003, epidemiology researcher Nicolas Maire and his colleagues at the Swiss Tropical Institute in Basel began simulating how potential malaria vaccines would affect populations where the disease is most prevalent. They ran the program on a network of several dozen of their institute's computers. But as the research team graduated to the second phase of their project in 2006, adding more variables, complex interactions and data to their model, it became clear that they needed more processing power.
The new simulations could take months or years to complete on their network, and other local computing facilities had long waits or were too expensive, the team concluded. Instead they bet that, given the project's humanitarian appeal, they could recruit volunteers to crunch the data. The wager paid off: Today, nearly 35,000 users run malariacontrol.net's calculations while their computers are idle, allowing the team to complete simulations far more quickly than would otherwise have been possible. Some of the research group's findings, based on its network of home-computer users in the U.S., Europe, South America, Australia and elsewhere, have been reported in leading journals like Parasitology and Malaria Journal.
Volunteer computing, as it's known, dates back to 1996, when a group of researchers enlisted participants in a search for ever-larger prime numbers, an effort that continues to break world records. Several years later, volunteers flocked to SETI@home, a project to sift through the static in radio telescope data for signs of extraterrestrial life.
In Myanmar, medicine is distributed to control malaria, a disease that is easy to treat but remains one of the nation's biggest killers. The government's health-care spending is the lowest world-wide
In the last five years, biomedical researchers have caught on to the possibilities of volunteer computing, and so too have the volunteers. James Whitus, who describes himself as "just an average Joe helping out," had been contributing his home computer's processing power to SETI@home until late 2004. Then he heard about the World Community Grid, a not-for-profit IBM project that provides research support to a number of different medical and humanitarian studies.
"I figured why search for extraterrestrials when you can help with research?" Mr. Whitus says. "Something that could actually make a difference here on this planet."
Today, the 28-year-old car inspector in Lafayette, Ind., and his fiancee support the grid's projects—which range from cancer-drug research to improving crop yields in developing countries—on their two desktop computers and on an old laptop that they devote solely to the cause.
Such volunteer computing projects are generally based on open-source software called the Berkeley Open Infrastructure of Network Computing, or Boinc. Volunteers download the simple application from boinc.berkeley.edu, and sign up for the projects they want to support. (Not all projects have lofty goals: One searches for the Sudoku puzzle with the fewest initial entries.)
Security Risks
An open network of so many computers might seem a security risk, and it is. But David Anderson, the Berkeley scientist who founded Boinc in 2004, says he has taken two key precautions. The first uses a system of digital signatures so that hackers cannot hijack an existing project's network. The second cordons off, or "sandboxes," all Boinc activity from the rest of a host computer, so that even if a bug or malicious code did slip into a project, it would cause minimal damage.
Still, volunteers should learn more about projects before joining them, Dr. Anderson suggests. Several sites, including Boinc's official page, host message boards where volunteers can discuss projects. After five years and more than 300,000,000 tasks performed by volunteers' computers, "there have been zero security incidents," according to Dr. Anderson.
There's also the cost to volunteers, in a higher energy bill, from keeping a computer running at all times. According to an estimate on Boinc's community-edited Web page (from the Boinc home page, search Heat and Energy Considerations), running Boinc costs about $3 a month more than leaving a computer on but idle, and about $8.80 a month more than leaving it off all the time, based on typical U.S. energy costs. The typical cost in Europe is about 200% higher, the site says.
Helping Out
See some biomedical research projects enlisting volunteer computers at boinc.berkeley.edu.
Downloading, setting up and running Boinc is no more difficult than for most other software, although it lacks the polished interface and technical support of many higher-end applications. Users with older computers should be prepared for certain frustrations, as one reporter learned by trial. A few projects refused to send any work to this volunteer's 2004 mid-range laptop, for lack of computing power. What parcels of work that were received took up to 18 hours of idle time to complete. (System requirements for individual projects are usually available on their Web sites.) After upgrading to a newer laptop, work parcels flowed where they had previously been blocked, and each took closer to four hours to complete.
Advances in personal-computer and Internet speeds have helped to triple the combined power of the volunteer computing efforts over the past two years, according to data from the site boincstats.com. Today the approximately 60 projects using Boinc harness in total about 2,500 teraflops—or twice the operations per second of the world's most powerful computer—from four million computers owned by nearly two million users. About 20 of those projects are related to medical research, to which more than 300,000 volunteers contribute. That includes the various efforts that comprise the World Community Grid.
Any scientist with the skills to set up a server can become part of the Boinc network. Researchers in most cases must pay for the servers that dispatch, gather and analyze the volunteers' data. But those costs are a small fraction of the roughly $1 million a year it costs to run a low-end supercomputer. (IBM's World Community Grid is free of cost to researchers, but the projects must be approved by an external advisory board.)
The top-supported biomedical project on Boinc is Rosetta@home, which simulates how proteins fold and could lead to novel treatments for a range of diseases. The sequence of the amino acids that comprise a protein—what may look like a whirling, intertwined, chaotic mess—precisely determines its structure and biological function. But exactly how these proteins bend along each amino acid is a vastly complex problem, one that the project's 80,000 volunteered computers help to solve by testing various permutations looking, essentially, for the most stable structure.
Don't Exist in Nature
The findings allow the Rosetta lab, run by David Baker at the University of Washington, to design proteins that don't exist in nature. Some new proteins could deactivate viruses such as the flu—as Dr. Baker's lab is trying to do for this year's H1N1 strain—by attaching to and smothering the sections of the pathogens that harm human cells. The project's biggest breakthroughs in the last couple of years have been in creating catalysts, which selectively speed up chemical reactions and which regulate almost every biological process, Dr. Baker said. One catalyst in development, for instance, is an enzyme that could slice apart genes in female mosquitoes, potentially preventing malaria transmission without using toxic chemicals.
Scientific studies that make use of the Boinc network have shown some promise, but no breakthroughs, researchers say. Findings from Rosetta@home have been published in the journals Science and Nature. But "what we haven't done yet is create enzymes that cure diseases," Dr. Baker said.
Similarly, projects associated with World Community Grid have generated dozens of research papers published in highly regarded journals. But, said Joseph Jasinski, an IBM engineer who works closely with the projects: "Have we discovered a new drug for curing AIDS? No. But we've found some great candidates."
Comment
I support this project and donate all my desktop time to it. It is my little contribution to science and research.
Users Make Their Home PCs Available to Chase Medical By JEREMY SINGER-VINE
The next cure for a major disease is as likely to be discovered on a computer as on a laboratory bench—and scientists are enlisting ordinary citizens to volunteer to help crunch the data.
Advances in computer science have enabled medical researchers to test how proteins fold, genes interact and pandemics spread in complex digital simulations of natural environments. As these simulations become more intensive and widely used, however, computers at academic institutions and other research facilities can't keep up with the demand for medical processing power.
Indian border security guards, who regularly contract malaria, are required to carry repellents and masks. Instead, scientists are tapping into a vast network that allows the research to be parceled out in tiny workloads that can be performed on anyone's household computer when it's not otherwise being used. So far, hundreds of thousands of people in countries around the world have volunteered their computers' processing power to help advance the cause of medical research.
Here's how it works: Volunteers download an application onto their home computer that links them into a network that includes other citizen volunteers and research scientists. The network assigns each computer a small bit of a project's puzzle to solve. The process, which continues as long as the computer is turned on but idle, typically takes several hours, but can vary depending on the project and the individual computer's power. When complete, the results are automatically sent back to the network's server.
In 2003, epidemiology researcher Nicolas Maire and his colleagues at the Swiss Tropical Institute in Basel began simulating how potential malaria vaccines would affect populations where the disease is most prevalent. They ran the program on a network of several dozen of their institute's computers. But as the research team graduated to the second phase of their project in 2006, adding more variables, complex interactions and data to their model, it became clear that they needed more processing power.
The new simulations could take months or years to complete on their network, and other local computing facilities had long waits or were too expensive, the team concluded. Instead they bet that, given the project's humanitarian appeal, they could recruit volunteers to crunch the data. The wager paid off: Today, nearly 35,000 users run malariacontrol.net's calculations while their computers are idle, allowing the team to complete simulations far more quickly than would otherwise have been possible. Some of the research group's findings, based on its network of home-computer users in the U.S., Europe, South America, Australia and elsewhere, have been reported in leading journals like Parasitology and Malaria Journal.
Volunteer computing, as it's known, dates back to 1996, when a group of researchers enlisted participants in a search for ever-larger prime numbers, an effort that continues to break world records. Several years later, volunteers flocked to SETI@home, a project to sift through the static in radio telescope data for signs of extraterrestrial life.
In Myanmar, medicine is distributed to control malaria, a disease that is easy to treat but remains one of the nation's biggest killers. The government's health-care spending is the lowest world-wide
In the last five years, biomedical researchers have caught on to the possibilities of volunteer computing, and so too have the volunteers. James Whitus, who describes himself as "just an average Joe helping out," had been contributing his home computer's processing power to SETI@home until late 2004. Then he heard about the World Community Grid, a not-for-profit IBM project that provides research support to a number of different medical and humanitarian studies.
"I figured why search for extraterrestrials when you can help with research?" Mr. Whitus says. "Something that could actually make a difference here on this planet."
Today, the 28-year-old car inspector in Lafayette, Ind., and his fiancee support the grid's projects—which range from cancer-drug research to improving crop yields in developing countries—on their two desktop computers and on an old laptop that they devote solely to the cause.
Such volunteer computing projects are generally based on open-source software called the Berkeley Open Infrastructure of Network Computing, or Boinc. Volunteers download the simple application from boinc.berkeley.edu, and sign up for the projects they want to support. (Not all projects have lofty goals: One searches for the Sudoku puzzle with the fewest initial entries.)
Security Risks
An open network of so many computers might seem a security risk, and it is. But David Anderson, the Berkeley scientist who founded Boinc in 2004, says he has taken two key precautions. The first uses a system of digital signatures so that hackers cannot hijack an existing project's network. The second cordons off, or "sandboxes," all Boinc activity from the rest of a host computer, so that even if a bug or malicious code did slip into a project, it would cause minimal damage.
Still, volunteers should learn more about projects before joining them, Dr. Anderson suggests. Several sites, including Boinc's official page, host message boards where volunteers can discuss projects. After five years and more than 300,000,000 tasks performed by volunteers' computers, "there have been zero security incidents," according to Dr. Anderson.
There's also the cost to volunteers, in a higher energy bill, from keeping a computer running at all times. According to an estimate on Boinc's community-edited Web page (from the Boinc home page, search Heat and Energy Considerations), running Boinc costs about $3 a month more than leaving a computer on but idle, and about $8.80 a month more than leaving it off all the time, based on typical U.S. energy costs. The typical cost in Europe is about 200% higher, the site says.
Helping Out
See some biomedical research projects enlisting volunteer computers at boinc.berkeley.edu.
Downloading, setting up and running Boinc is no more difficult than for most other software, although it lacks the polished interface and technical support of many higher-end applications. Users with older computers should be prepared for certain frustrations, as one reporter learned by trial. A few projects refused to send any work to this volunteer's 2004 mid-range laptop, for lack of computing power. What parcels of work that were received took up to 18 hours of idle time to complete. (System requirements for individual projects are usually available on their Web sites.) After upgrading to a newer laptop, work parcels flowed where they had previously been blocked, and each took closer to four hours to complete.
Advances in personal-computer and Internet speeds have helped to triple the combined power of the volunteer computing efforts over the past two years, according to data from the site boincstats.com. Today the approximately 60 projects using Boinc harness in total about 2,500 teraflops—or twice the operations per second of the world's most powerful computer—from four million computers owned by nearly two million users. About 20 of those projects are related to medical research, to which more than 300,000 volunteers contribute. That includes the various efforts that comprise the World Community Grid.
Any scientist with the skills to set up a server can become part of the Boinc network. Researchers in most cases must pay for the servers that dispatch, gather and analyze the volunteers' data. But those costs are a small fraction of the roughly $1 million a year it costs to run a low-end supercomputer. (IBM's World Community Grid is free of cost to researchers, but the projects must be approved by an external advisory board.)
The top-supported biomedical project on Boinc is Rosetta@home, which simulates how proteins fold and could lead to novel treatments for a range of diseases. The sequence of the amino acids that comprise a protein—what may look like a whirling, intertwined, chaotic mess—precisely determines its structure and biological function. But exactly how these proteins bend along each amino acid is a vastly complex problem, one that the project's 80,000 volunteered computers help to solve by testing various permutations looking, essentially, for the most stable structure.
Don't Exist in Nature
The findings allow the Rosetta lab, run by David Baker at the University of Washington, to design proteins that don't exist in nature. Some new proteins could deactivate viruses such as the flu—as Dr. Baker's lab is trying to do for this year's H1N1 strain—by attaching to and smothering the sections of the pathogens that harm human cells. The project's biggest breakthroughs in the last couple of years have been in creating catalysts, which selectively speed up chemical reactions and which regulate almost every biological process, Dr. Baker said. One catalyst in development, for instance, is an enzyme that could slice apart genes in female mosquitoes, potentially preventing malaria transmission without using toxic chemicals.
Scientific studies that make use of the Boinc network have shown some promise, but no breakthroughs, researchers say. Findings from Rosetta@home have been published in the journals Science and Nature. But "what we haven't done yet is create enzymes that cure diseases," Dr. Baker said.
Similarly, projects associated with World Community Grid have generated dozens of research papers published in highly regarded journals. But, said Joseph Jasinski, an IBM engineer who works closely with the projects: "Have we discovered a new drug for curing AIDS? No. But we've found some great candidates."
Comment
I support this project and donate all my desktop time to it. It is my little contribution to science and research.
Gaps in DNA banks lead to tragedy
Tens of thousands of missing samples prevent police from solving crimes
Jeffrey Phelps / AP
Police say murder suspect Walter Ellis, shown in September, eluded capture for 20 years because authorities did not have his DNA on file.
Most viewed on msnbc.com
updated 5:40 p.m. ET, Mon., Dec . 14, 2009
MADISON, Wis. - During what police say was a 20-year killing spree in Milwaukee, Walter Ellis left his DNA behind all along the way — everywhere but the one place where it might have saved a life.
Ellis should have given a DNA sample to the state crime databank during a prison stint in the early part of this decade, but he had another inmate pose as him, authorities say. As a result, when analysts tried to identify DNA in bodily fluids from one of the slayings back in 2003, no matches turned up.
Investigators didn't connect Ellis to the crimes until this fall, when they seized genetic material from his toothbrush. By then, it was too late for the woman police say was Ellis' seventh and final victim.
"If they would have got his DNA when they were supposed to get it, maybe my cousin would still be here," said Sarah Stokes, whose cousin, 28-year-old prostitute Ouithreaun Stokes, was found beaten and strangled in an abandoned rooming house in 2007.
An Associated Press review found tens of thousands of DNA samples are missing from state databanks across the country because they were never taken or were lost. The missing evidence — combined with big backlogs at the nation's crime labs that result in DNA samples sitting on shelves for years without being analyzed and entered into the databanks — is preventing investigators from cracking untold numbers of cases. And some of those gaps have had tragic consequences.
"If you got missing samples, some of those people are out there raping your wives and abducting and murdering your children this week," said former Charlottesville, Va., police Capt. J.E. Harding, who helped uncover missing samples in that state during a search for a serial rapist.
Confusing laws blamed
Crime lab supervisors, state police and prison officials blame the failure to collect samples on new and confusing laws and a lack of coordination among the many different law enforcement agencies and institutions responsible for taking DNA.
"I would just about guarantee you every state has an issue with this," said Lisa Hurst, who tracks DNA convictions for Gordon Thomas Honeywell, an organization that lobbies on public safety and biotechnology issues.
The AP review found 27 states either failed to collect some DNA samples or are unable to say whether they took one from every offender who owes one.
The case against Ellis, who is set to go trial this spring, prompted an audit in Wisconsin that found 12,000 convict samples are missing. The AP review further found that Illinois failed to get DNA from about 50,000 offenders, Colorado from 2,000, and Virginia from about 8,400.
Exactly how many samples are missing across the country is unknown. The National Institute of Justice estimated in 2003 that offenders owed up to 1 million uncollected samples and as many as 300,000 samples may be waiting for processing. The backlog grew to about 450,000 by 2008. The institute had no updated estimate of uncollected samples.
Backlog at labs
At least 13 states are dealing with more samples than they can handle. Kansas, for example, has nearly 40,000 on its crime lab shelves, waiting for upload.
Police in Columbus, Ohio, say Robert N. Patton Jr. committed 37 rapes over a decade and a half. As with Ellis in Milwaukee, he could have been stopped earlier.
Patton had submitted his DNA in 2001 while behind bars for burglary, but it was not entered into the database until 2004, two days before he climbed through an apartment window and raped Diana Cunningham. Police say he attacked 13 women in all after supplying his DNA.
If Patton's genetic material "had been processed in a timely fashion, he never would have gotten to me or gotten to any of the others," said Cunningham, now 25. "It's scary how many more people are going to be victimized because their attackers aren't going to be caught. And it would be so easy for them to be caught if they could make the matches."
Patton is now serving a 68-year prison sentence.
Comment
QWhy donmt we spend some of the stimulus money to get up to date? That would create American jobs, right?
Jeffrey Phelps / AP
Police say murder suspect Walter Ellis, shown in September, eluded capture for 20 years because authorities did not have his DNA on file.
Most viewed on msnbc.com
updated 5:40 p.m. ET, Mon., Dec . 14, 2009
MADISON, Wis. - During what police say was a 20-year killing spree in Milwaukee, Walter Ellis left his DNA behind all along the way — everywhere but the one place where it might have saved a life.
Ellis should have given a DNA sample to the state crime databank during a prison stint in the early part of this decade, but he had another inmate pose as him, authorities say. As a result, when analysts tried to identify DNA in bodily fluids from one of the slayings back in 2003, no matches turned up.
Investigators didn't connect Ellis to the crimes until this fall, when they seized genetic material from his toothbrush. By then, it was too late for the woman police say was Ellis' seventh and final victim.
"If they would have got his DNA when they were supposed to get it, maybe my cousin would still be here," said Sarah Stokes, whose cousin, 28-year-old prostitute Ouithreaun Stokes, was found beaten and strangled in an abandoned rooming house in 2007.
An Associated Press review found tens of thousands of DNA samples are missing from state databanks across the country because they were never taken or were lost. The missing evidence — combined with big backlogs at the nation's crime labs that result in DNA samples sitting on shelves for years without being analyzed and entered into the databanks — is preventing investigators from cracking untold numbers of cases. And some of those gaps have had tragic consequences.
"If you got missing samples, some of those people are out there raping your wives and abducting and murdering your children this week," said former Charlottesville, Va., police Capt. J.E. Harding, who helped uncover missing samples in that state during a search for a serial rapist.
Confusing laws blamed
Crime lab supervisors, state police and prison officials blame the failure to collect samples on new and confusing laws and a lack of coordination among the many different law enforcement agencies and institutions responsible for taking DNA.
"I would just about guarantee you every state has an issue with this," said Lisa Hurst, who tracks DNA convictions for Gordon Thomas Honeywell, an organization that lobbies on public safety and biotechnology issues.
The AP review found 27 states either failed to collect some DNA samples or are unable to say whether they took one from every offender who owes one.
The case against Ellis, who is set to go trial this spring, prompted an audit in Wisconsin that found 12,000 convict samples are missing. The AP review further found that Illinois failed to get DNA from about 50,000 offenders, Colorado from 2,000, and Virginia from about 8,400.
Exactly how many samples are missing across the country is unknown. The National Institute of Justice estimated in 2003 that offenders owed up to 1 million uncollected samples and as many as 300,000 samples may be waiting for processing. The backlog grew to about 450,000 by 2008. The institute had no updated estimate of uncollected samples.
Backlog at labs
At least 13 states are dealing with more samples than they can handle. Kansas, for example, has nearly 40,000 on its crime lab shelves, waiting for upload.
Police in Columbus, Ohio, say Robert N. Patton Jr. committed 37 rapes over a decade and a half. As with Ellis in Milwaukee, he could have been stopped earlier.
Patton had submitted his DNA in 2001 while behind bars for burglary, but it was not entered into the database until 2004, two days before he climbed through an apartment window and raped Diana Cunningham. Police say he attacked 13 women in all after supplying his DNA.
If Patton's genetic material "had been processed in a timely fashion, he never would have gotten to me or gotten to any of the others," said Cunningham, now 25. "It's scary how many more people are going to be victimized because their attackers aren't going to be caught. And it would be so easy for them to be caught if they could make the matches."
Patton is now serving a 68-year prison sentence.
Comment
QWhy donmt we spend some of the stimulus money to get up to date? That would create American jobs, right?
Tuesday, December 1, 2009
Looking For Waste in the Health Care System? Try Anywhere
Francine Hardaway - Serial entrepreneurship veteran
Posted: December 1, 2009 12:00 PM BIO Become a Fan Get Email Alerts Bloggers' Index
Looking For Waste in the Health Care System? Try Anywhere
Read More: Health Care, Maggie Mahar, Mammograms, Medicare Fraud Cost, Pharmaceutical Industry, Simivastin, Vitorian, Zetia, Living News
How much of our rising health care costs comes from fraud in the health care system by players who know how to game it for their own benefit? Enough to cloud the reform debate, that's for sure. And it can't be pinned on one player; it's up and down the value chain in medical care.
On the one hand, you have the recent 60-Minutes report on drug dealers in Miami who defraud Medicare by opening fake clinics and pharmacies. They get reimbursed for artificial limbs ordered for patients whose IDs they have bought on a black market for Medicare information.
Further up the line you have hospitals who bill Medicare for procedures that could be done in an outpatient setting where they would cost less, or for total care of a patient whose actual care is split between two hospitals, both of whom bill for the entire care. (Go look on the Center for Medicare and Medicaid Services web site for the Recovery Audit Contractor pilot program in which this was discovered.
And then there's the sweetheart deal the insurers got to participate in the Medicare Advantage program, which was started when CMS was afraid not enough providers would participate in Medicare. In Medicare Advantage, all the players get paid more than by regular Medicare for providing the same services. Medicare Advantage is targeted by the cost-cutting initiatives, but here's what the plans said: "many commenters contend that, if rates are reduced, MA organizations will have trouble maintaining their provider networks, because they will have to pay providers less, and will have to raise premiums, increase co-pays and deductibles, especially in rural areas, Puerto Rico, in the case of Special Needs Plans (SNPs), PACE plans, and plans that are in direct competition with cost plans."
Finally, we get to the pharmaceutical companies, where we learn that "by suppressing negative studies, relentlessly pursuing positive trial results, and paying academic researchers to promote their therapy, Merck Schering-Plough has managed to hold onto a $4.6 billion market for a drug that has never been proven to be better than cheaper generics in preventing heart attacks or death. "
That's a pretty shocking allegation from the HealthBeatBlog, where Maggie Mahar, maker of the film "Money-Driven Medicine," does her investigative work. It seems that Merck Schering-Plough holds the patents on Vitorin and Zetia, two widely advertised drugs that in studies have proven no more effective than the vitamin niacin and a generic statin, simivastin.
And this doesn't even begin to touch controversial issues like outcomes-based medicine, which might mean fewer mammograms, CT scans, and other procedures that irradiate us often unnecessarily as the doctor either tries to prevent malpractice allegations or perhaps even owns the imaging center.
Everywhere you look there is waste and downright fraud in the health care system, perpetrated by both payers and providers, public and private. I have no doubt that Obama is right that we could fund health care reform by cleaning up the waste, but the lobbyists for the staus quo don't want it cleaned up. They are profiting from waste and fraud, not from legitimate services, IMHO
Comment
cuppajoe
I would suggest that it is not all just out and out fraud. Here, in a community of about 80,000 where I currently reside, one can go to one hospital for a specific lab test, and Medicare is charged about $225.00; In a second hospital in the same basic community, the exact same test, bills Medicare approximately $80.00 for the same test.
And, to further look at this, there are an estimated 5,000 of these tests performed in this community each month; it is estimated that the more expensive hospital performs 75% of these tests. If my math is correct, 75% of 5000 is 3750. and the difference between $225. and $80 is $145.00 $145 x 3750 = $543,750 per month, or $6,525,000 per year, for one test, in one community. If these numbers apply, even remotely to the national picture, this one test, which is necessary, may well be costing Medicare more than a BILLION dollars more than it need cost.
It makes no sense to me. The test does not require the intervention of, nor the direct supervision of a physician, uses an inexpensive test strip, and one nurse can comfortably accomplish, with no rush, about 4 or 5 tests per hour. Without any degradation of nurses, is it really necessary to bill medicare approximately $1000 per hour for a nurse's time?
Posted: December 1, 2009 12:00 PM BIO Become a Fan Get Email Alerts Bloggers' Index
Looking For Waste in the Health Care System? Try Anywhere
Read More: Health Care, Maggie Mahar, Mammograms, Medicare Fraud Cost, Pharmaceutical Industry, Simivastin, Vitorian, Zetia, Living News
How much of our rising health care costs comes from fraud in the health care system by players who know how to game it for their own benefit? Enough to cloud the reform debate, that's for sure. And it can't be pinned on one player; it's up and down the value chain in medical care.
On the one hand, you have the recent 60-Minutes report on drug dealers in Miami who defraud Medicare by opening fake clinics and pharmacies. They get reimbursed for artificial limbs ordered for patients whose IDs they have bought on a black market for Medicare information.
Further up the line you have hospitals who bill Medicare for procedures that could be done in an outpatient setting where they would cost less, or for total care of a patient whose actual care is split between two hospitals, both of whom bill for the entire care. (Go look on the Center for Medicare and Medicaid Services web site for the Recovery Audit Contractor pilot program in which this was discovered.
And then there's the sweetheart deal the insurers got to participate in the Medicare Advantage program, which was started when CMS was afraid not enough providers would participate in Medicare. In Medicare Advantage, all the players get paid more than by regular Medicare for providing the same services. Medicare Advantage is targeted by the cost-cutting initiatives, but here's what the plans said: "many commenters contend that, if rates are reduced, MA organizations will have trouble maintaining their provider networks, because they will have to pay providers less, and will have to raise premiums, increase co-pays and deductibles, especially in rural areas, Puerto Rico, in the case of Special Needs Plans (SNPs), PACE plans, and plans that are in direct competition with cost plans."
Finally, we get to the pharmaceutical companies, where we learn that "by suppressing negative studies, relentlessly pursuing positive trial results, and paying academic researchers to promote their therapy, Merck Schering-Plough has managed to hold onto a $4.6 billion market for a drug that has never been proven to be better than cheaper generics in preventing heart attacks or death. "
That's a pretty shocking allegation from the HealthBeatBlog, where Maggie Mahar, maker of the film "Money-Driven Medicine," does her investigative work. It seems that Merck Schering-Plough holds the patents on Vitorin and Zetia, two widely advertised drugs that in studies have proven no more effective than the vitamin niacin and a generic statin, simivastin.
And this doesn't even begin to touch controversial issues like outcomes-based medicine, which might mean fewer mammograms, CT scans, and other procedures that irradiate us often unnecessarily as the doctor either tries to prevent malpractice allegations or perhaps even owns the imaging center.
Everywhere you look there is waste and downright fraud in the health care system, perpetrated by both payers and providers, public and private. I have no doubt that Obama is right that we could fund health care reform by cleaning up the waste, but the lobbyists for the staus quo don't want it cleaned up. They are profiting from waste and fraud, not from legitimate services, IMHO
Comment
cuppajoe
I would suggest that it is not all just out and out fraud. Here, in a community of about 80,000 where I currently reside, one can go to one hospital for a specific lab test, and Medicare is charged about $225.00; In a second hospital in the same basic community, the exact same test, bills Medicare approximately $80.00 for the same test.
And, to further look at this, there are an estimated 5,000 of these tests performed in this community each month; it is estimated that the more expensive hospital performs 75% of these tests. If my math is correct, 75% of 5000 is 3750. and the difference between $225. and $80 is $145.00 $145 x 3750 = $543,750 per month, or $6,525,000 per year, for one test, in one community. If these numbers apply, even remotely to the national picture, this one test, which is necessary, may well be costing Medicare more than a BILLION dollars more than it need cost.
It makes no sense to me. The test does not require the intervention of, nor the direct supervision of a physician, uses an inexpensive test strip, and one nurse can comfortably accomplish, with no rush, about 4 or 5 tests per hour. Without any degradation of nurses, is it really necessary to bill medicare approximately $1000 per hour for a nurse's time?
Loneliness can be contagious, new study finds
Feelings of isolation can spread through groups of friends as easily as a cold
Loneliness can not only make you feel more socially isolated, it can make you more anxious, more shy and cause you to believe you have poor social skills.
Ex-Miss Argentina dies after cosmetic surgery
Lone cop kills suspect in slaying of 4 officers
Some aren’t surprised by Tiger Woods mess
Rothstein charged in $1 billion Ponzi scheme
By Diane Mapes
msnbc.com contributor
updated 8:40 a.m. ET, Tues., Dec . 1, 2009
We’re used to hearing about people spreading colds and flu. But according to a new study in the Journal of Personality and Social Psychology, there’s another human condition that’s equally contagious: loneliness.
“Loneliness spreads across time,” says John Cacioppo, a neuroscientist and psychologist at the University of Chicago and one of the authors of the study. “It travels through people. Instead of a germ, it’s transmitted through our behaviors.”
The longitudinal study, conducted by the University of Chicago, the University of California-San Diego and Harvard, interviewed more than 5,000 people over the course of 10 years, tracking their friendship histories and their reports of loneliness. Participants were part of the Framingham Heart Study, which has studied cardiovascular risks in people in Framingham, Mass., since 1948 and has since been expanded to include other research topics such as loneliness and depression.
In the study, researchers found that lonely individuals tend to move to the fringes of social networks (and, no, we’re not talking about Facebook or Twitter here), where they have fewer and fewer friends.
But before they move to the periphery, they “infect” or “transmit” their feelings of loneliness to their remaining friends. With fewer close relationship, these friends then become lonely and eventually move to the fringes of the social network, again passing their loneliness on to others. Thus, the cycle continues.
“When people get lonely, they’re more likely to interact negatively with others they encounter,” says Cacioppo. “If you have two neighbors and they’re friends and one becomes lonely, they’ll start to treat the other less friendly. Ultimately, they’re less likely to be friends.”
Ironically, loneliness can not only make you feel more socially isolated, it can make you more anxious, more shy and cause you to believe you have poor social skills. Cacioppo says previous research also shows that loneliness can make people less trustful of others and can make the brain more “defensive.”
“Your brain tells you people are rejecting you,” he says. “Loneliness may warp the message that you’re hearing.”
A biological signal
While loneliness can be “contagious,” Cacioppo says it’s important to note it’s not a disease, nor is it a personal weakness. It’s actually a biological reaction, much like hunger or thirst or pain.
“Society tends to think of it as an individual characteristic — there are just loners,” he says. “But that’s the wrong conception of what loneliness is. It’s a biological signal motivating us to correct something that we need for genetic survival. We need quality relationships. We don’t survive well on our own.”
Studies, in fact, show loneliness can actually be harmful to both mental and physical health, leading to depression, high blood pressure, increases in the stress hormone cortisol, and compromised immunity.
Unfortunately, quality friendships can sometimes be difficult to find or maintain in our busy, BlackBerried society.
“I get lonely sometimes but I tend not to seek people out to do things because they’re all married or committed or need to find a babysitter and then it just turns into a circus,” says Tina Kurfurst, a 46-year-old database coordinator from Seattle. “I went out to dinner with some people from work the other night and one of the women kept saying, ‘Wow, you’re funny, why don’t we hang out more often?’ And I just thought, ‘Well, because you have a husband and a 12-year-old and a 17-year-old and it just doesn’t happen. You don’t have time for me.”
Stephanie Smith, a clinical psychologist with a private practice in Erie, Co., says she tries to encourage her lonely patients — which can range from college students to stay-at-home moms to high-powered CEOs — to find at least one friend in their same situation.
“If you have kids, know at least one other person who has kids,” she says. “Or if you don’t, find someone who doesn’t. It’s important to have people in your life who share your interests and your stage of life.”
But you don’t have to have a slew of BFFs.
“Sometimes people get overwhelmed and think ‘I need to have 15 best friends,’” she says. “But it doesn’t need to be that big. One friend, one relationship, can be very powerful.”
Click for related content
Why we can't remember who we've told what
Why memory lane is such a mortifying stroll
Sleepless in ... West Virginia?
Looking at nature makes you nicer
Facebook and Twitter are no substitute for the real thing, though.
“If you’re isolated due to a disability or a spouse with Alzheimer’s, then Facebook can be a real boon,” says Cacioppo. “But if you’re spending your time on Facebook rather than face-to-face with friends, it increases your loneliness. It’s about quality. Lonely people use social networks as a substitute; non-lonely people use them to synergize the relationships they already have. The person with 4,000 friends on Facebook may well be a very lonely person.”
The secret, says Cacioppo, is realizing loneliness is nothing more than your body sending you a signal.
“All normal humans feel lonely at some point in time, just like they feel hunger and thirst and pain,” he says. “But while we have cupboards filled with food, taps for water and medications for pain, we don’t have anything comparable for loneliness. I’m not saying you need a cupboard full of friends, but if you feel lonely, pay attention and take the time to repair it.”
Comment
I cant remember who said it but somebody said they judge ones mental health by the quality and quantity of their friendships.
Loneliness can not only make you feel more socially isolated, it can make you more anxious, more shy and cause you to believe you have poor social skills.
Ex-Miss Argentina dies after cosmetic surgery
Lone cop kills suspect in slaying of 4 officers
Some aren’t surprised by Tiger Woods mess
Rothstein charged in $1 billion Ponzi scheme
By Diane Mapes
msnbc.com contributor
updated 8:40 a.m. ET, Tues., Dec . 1, 2009
We’re used to hearing about people spreading colds and flu. But according to a new study in the Journal of Personality and Social Psychology, there’s another human condition that’s equally contagious: loneliness.
“Loneliness spreads across time,” says John Cacioppo, a neuroscientist and psychologist at the University of Chicago and one of the authors of the study. “It travels through people. Instead of a germ, it’s transmitted through our behaviors.”
The longitudinal study, conducted by the University of Chicago, the University of California-San Diego and Harvard, interviewed more than 5,000 people over the course of 10 years, tracking their friendship histories and their reports of loneliness. Participants were part of the Framingham Heart Study, which has studied cardiovascular risks in people in Framingham, Mass., since 1948 and has since been expanded to include other research topics such as loneliness and depression.
In the study, researchers found that lonely individuals tend to move to the fringes of social networks (and, no, we’re not talking about Facebook or Twitter here), where they have fewer and fewer friends.
But before they move to the periphery, they “infect” or “transmit” their feelings of loneliness to their remaining friends. With fewer close relationship, these friends then become lonely and eventually move to the fringes of the social network, again passing their loneliness on to others. Thus, the cycle continues.
“When people get lonely, they’re more likely to interact negatively with others they encounter,” says Cacioppo. “If you have two neighbors and they’re friends and one becomes lonely, they’ll start to treat the other less friendly. Ultimately, they’re less likely to be friends.”
Ironically, loneliness can not only make you feel more socially isolated, it can make you more anxious, more shy and cause you to believe you have poor social skills. Cacioppo says previous research also shows that loneliness can make people less trustful of others and can make the brain more “defensive.”
“Your brain tells you people are rejecting you,” he says. “Loneliness may warp the message that you’re hearing.”
A biological signal
While loneliness can be “contagious,” Cacioppo says it’s important to note it’s not a disease, nor is it a personal weakness. It’s actually a biological reaction, much like hunger or thirst or pain.
“Society tends to think of it as an individual characteristic — there are just loners,” he says. “But that’s the wrong conception of what loneliness is. It’s a biological signal motivating us to correct something that we need for genetic survival. We need quality relationships. We don’t survive well on our own.”
Studies, in fact, show loneliness can actually be harmful to both mental and physical health, leading to depression, high blood pressure, increases in the stress hormone cortisol, and compromised immunity.
Unfortunately, quality friendships can sometimes be difficult to find or maintain in our busy, BlackBerried society.
“I get lonely sometimes but I tend not to seek people out to do things because they’re all married or committed or need to find a babysitter and then it just turns into a circus,” says Tina Kurfurst, a 46-year-old database coordinator from Seattle. “I went out to dinner with some people from work the other night and one of the women kept saying, ‘Wow, you’re funny, why don’t we hang out more often?’ And I just thought, ‘Well, because you have a husband and a 12-year-old and a 17-year-old and it just doesn’t happen. You don’t have time for me.”
Stephanie Smith, a clinical psychologist with a private practice in Erie, Co., says she tries to encourage her lonely patients — which can range from college students to stay-at-home moms to high-powered CEOs — to find at least one friend in their same situation.
“If you have kids, know at least one other person who has kids,” she says. “Or if you don’t, find someone who doesn’t. It’s important to have people in your life who share your interests and your stage of life.”
But you don’t have to have a slew of BFFs.
“Sometimes people get overwhelmed and think ‘I need to have 15 best friends,’” she says. “But it doesn’t need to be that big. One friend, one relationship, can be very powerful.”
Click for related content
Why we can't remember who we've told what
Why memory lane is such a mortifying stroll
Sleepless in ... West Virginia?
Looking at nature makes you nicer
Facebook and Twitter are no substitute for the real thing, though.
“If you’re isolated due to a disability or a spouse with Alzheimer’s, then Facebook can be a real boon,” says Cacioppo. “But if you’re spending your time on Facebook rather than face-to-face with friends, it increases your loneliness. It’s about quality. Lonely people use social networks as a substitute; non-lonely people use them to synergize the relationships they already have. The person with 4,000 friends on Facebook may well be a very lonely person.”
The secret, says Cacioppo, is realizing loneliness is nothing more than your body sending you a signal.
“All normal humans feel lonely at some point in time, just like they feel hunger and thirst and pain,” he says. “But while we have cupboards filled with food, taps for water and medications for pain, we don’t have anything comparable for loneliness. I’m not saying you need a cupboard full of friends, but if you feel lonely, pay attention and take the time to repair it.”
Comment
I cant remember who said it but somebody said they judge ones mental health by the quality and quantity of their friendships.
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