Latest Drugwonks' Blog
Meat and milk from cloned animals! Calls for absurd, unscientific labeling!
Just another day at the FDA.
According to the FDA, “the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
Perhaps this cause will be taken up by a new consumer advocacy organization – MOOveOn.org.
(Sorry about that.)
Just another day at the FDA.
According to the FDA, “the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
Perhaps this cause will be taken up by a new consumer advocacy organization – MOOveOn.org.
(Sorry about that.)
Eureka! It works.
Attention Speaker Pelosi ...
ASSOCIATED PRESS
WASHINGTON – At first, Ruth Goundry wasn't sure about participating in the new Medicare drug benefit. It was too confusing, she said. But in the end, she gave it a try. She's glad she did.
As the program's first year draws to a close, Goundry estimates that she saved about $150 a month on her five medicines, compared with what she was spending before Medicare Part D began. “I would say I'm very impressed with the whole thing. I have no complaints,†said Goundry, a resident of Chesapeake Beach, Md. “It's meant a tremendous savings. I know other people who are saved by it. I mean that. They don't hardly pay anything.â€
Goundry is like millions of seniors who say they are happy with the benefit, which cost the federal government about $30 billion in 2006. But the program affects seniors and the disabled differently, depending upon their income and health. There are many people who believe the program could be improved.
Just down the street, at the Chesapeake Care Pharmacy, Wesley Copeland is not so impressed. In August, he began picking up all the cost of his medicine – about $300 a month. Plus, he had to continue paying his monthly premium of $38. That gap in coverage is called the doughnut hole. “We've got a lot of people in my neighborhood who are seniors like me on retirement. We have to stretch pennies, so when it gets to that doughnut hole, we have to scramble like hell to keep going,†Copeland said.
Goundry and Copeland represent the millions of stories surrounding the addition of a drug benefit to Medicare this past year. The drug coverage has often been described as the biggest change in Medicare in the program' 40 years. Under the program, seniors and the disabled enroll in a private plan. They pay a monthly premium to the plan. The government also pays the plan.
The Bush administration estimates that the coverage saves the average beneficiary about $1,200. But many in Washington, particularly Democratic lawmakers, say the savings could be greater if the government were allowed to negotiate with drug manufacturers concerning the cost of medicine rather than leaving that chore to the plans.
Overall, about 22.5 million people enrolled in private plans during the programs first year. Nearly 7 million more people get their medicine through their employer, and those employers get a tax credit for providing that coverage. That total of nearly 30 million getting coverage through Part D is much less than was originally projected. However, analysts also didn't realize that so many seniors had insurance coverage for their medicine through other programs.
The Bush administration acknowledges the program got off to a rough start as hundreds of thousands of people showed up in pharmacy computers as not being enrolled in a plan. Beverly Dillon, a pharmacy technician in Chesapeake Beach, said that in the program's early weeks, her store advanced about 75 to 100 patients medicine to help them get by. “We would not let patients go without their medication,†she said.
The state of Maryland also stepped in to pick up the cost of medicine for poor beneficiaries, she noted. Most other states did as well. “January and February were absolutely crazy,†she said. “I would say that around March, or late February, things started to calm down.†She said many seniors are still confused about the program. To prove her point, a customer came into the store to get a refill. Dillon noted that she was in a Part D plan, but the customer was insistent that she was not and that she had coverage through another program. Dillon relented, not wanting to upset her.
Dillon said most customers who did not have insurance coverage prior to the past year are saving money. She has noticed that the checks they write to the pharmacy now are much smaller. “There's definitely a significant savings,†she said. “(But) the program just got off to such a bad start in the beginning, it just has not been smooth.â€
Dillon is bracing for some rough spots in the coming weeks too. That's because some seniors are switching plans. Others have been automatically enrolled in new plans. Herb Kuhn, deputy administrator at the Centers for Medicare and Medicaid Services, said that he believes the federal government learned many lessons from the past year that will make this year's startup run more smoothly. “We have a much more sophisticated and built up infrastructure from a year ago,†Kuhn said.
Kuhn said his biggest concern going into the new year are those beneficiaries who waited until the final days of the open-enrollment period to change drug plans. He said seniors should bring to the pharmacy any kind of identification or acknowledgment letter from their plan that would show proof of membership.
Overall, Kuhn said that 2006 was a good year for beneficiaries. “We believe it's been a very positive year for Part D,†he said. “As a result of the new program, beneficiaries are living better. They're saving money.â€
Attention Speaker Pelosi ...
ASSOCIATED PRESS
WASHINGTON – At first, Ruth Goundry wasn't sure about participating in the new Medicare drug benefit. It was too confusing, she said. But in the end, she gave it a try. She's glad she did.
As the program's first year draws to a close, Goundry estimates that she saved about $150 a month on her five medicines, compared with what she was spending before Medicare Part D began. “I would say I'm very impressed with the whole thing. I have no complaints,†said Goundry, a resident of Chesapeake Beach, Md. “It's meant a tremendous savings. I know other people who are saved by it. I mean that. They don't hardly pay anything.â€
Goundry is like millions of seniors who say they are happy with the benefit, which cost the federal government about $30 billion in 2006. But the program affects seniors and the disabled differently, depending upon their income and health. There are many people who believe the program could be improved.
Just down the street, at the Chesapeake Care Pharmacy, Wesley Copeland is not so impressed. In August, he began picking up all the cost of his medicine – about $300 a month. Plus, he had to continue paying his monthly premium of $38. That gap in coverage is called the doughnut hole. “We've got a lot of people in my neighborhood who are seniors like me on retirement. We have to stretch pennies, so when it gets to that doughnut hole, we have to scramble like hell to keep going,†Copeland said.
Goundry and Copeland represent the millions of stories surrounding the addition of a drug benefit to Medicare this past year. The drug coverage has often been described as the biggest change in Medicare in the program' 40 years. Under the program, seniors and the disabled enroll in a private plan. They pay a monthly premium to the plan. The government also pays the plan.
The Bush administration estimates that the coverage saves the average beneficiary about $1,200. But many in Washington, particularly Democratic lawmakers, say the savings could be greater if the government were allowed to negotiate with drug manufacturers concerning the cost of medicine rather than leaving that chore to the plans.
Overall, about 22.5 million people enrolled in private plans during the programs first year. Nearly 7 million more people get their medicine through their employer, and those employers get a tax credit for providing that coverage. That total of nearly 30 million getting coverage through Part D is much less than was originally projected. However, analysts also didn't realize that so many seniors had insurance coverage for their medicine through other programs.
The Bush administration acknowledges the program got off to a rough start as hundreds of thousands of people showed up in pharmacy computers as not being enrolled in a plan. Beverly Dillon, a pharmacy technician in Chesapeake Beach, said that in the program's early weeks, her store advanced about 75 to 100 patients medicine to help them get by. “We would not let patients go without their medication,†she said.
The state of Maryland also stepped in to pick up the cost of medicine for poor beneficiaries, she noted. Most other states did as well. “January and February were absolutely crazy,†she said. “I would say that around March, or late February, things started to calm down.†She said many seniors are still confused about the program. To prove her point, a customer came into the store to get a refill. Dillon noted that she was in a Part D plan, but the customer was insistent that she was not and that she had coverage through another program. Dillon relented, not wanting to upset her.
Dillon said most customers who did not have insurance coverage prior to the past year are saving money. She has noticed that the checks they write to the pharmacy now are much smaller. “There's definitely a significant savings,†she said. “(But) the program just got off to such a bad start in the beginning, it just has not been smooth.â€
Dillon is bracing for some rough spots in the coming weeks too. That's because some seniors are switching plans. Others have been automatically enrolled in new plans. Herb Kuhn, deputy administrator at the Centers for Medicare and Medicaid Services, said that he believes the federal government learned many lessons from the past year that will make this year's startup run more smoothly. “We have a much more sophisticated and built up infrastructure from a year ago,†Kuhn said.
Kuhn said his biggest concern going into the new year are those beneficiaries who waited until the final days of the open-enrollment period to change drug plans. He said seniors should bring to the pharmacy any kind of identification or acknowledgment letter from their plan that would show proof of membership.
Overall, Kuhn said that 2006 was a good year for beneficiaries. “We believe it's been a very positive year for Part D,†he said. “As a result of the new program, beneficiaries are living better. They're saving money.â€
In the heydays of “drugs from Canada,†there were news stories aplenty about the “Winnipeg Wunderkids,†the young pharmacists who were selling drugs to Americans and driving around in Dodge Viper sportscars. These reports rarely mentioned that they were trafficking in illegal merchandise. And there was a lot of talk of “it’s not about the money, it’s about helping people.â€
That, as it turned out, was soooo 2004. Today they going out of business and, well, it’s all about the money. People are losing their jobs – but it doesn’t seem that those who got rich quick are doing anything to help those they led down the primrose path of ill-gotten gains – except maybe letting their former employees wash their fancy cars.
Here’s the story as reported in the Winnipeg Free Press.
MINNEDOSA -- The Internet pharmacy pioneers who gave birth to a half-billion-dollar industry in Canada, most of it in Manitoba, are exiting the industry. MediPlan, founded almost six years ago by four Winnipeg wunderkids ages 21 to 26, will close its doors at the end of this month here, 200 kilometres northwest of Winnipeg. About 75 people are being thrown out of work.
At its peak, MediPlan employed 170 people in Minnedosa. "There's nobody here... We're just winding down," said a woman in the human resources department on the MediPlan's second floor last week.
CanadaDrugs.com in Winnipeg has purchased MediPlan and the jobs will move to the capital city. At least 30 new employees will be needed at CanadaDrugs, a spokesman said. As the industry leader for much of its run, MediPlan, which also goes by RxNorth, had been the prime target for opponents like non-Internet pharmacies, the drug giants, and Canadian and American governments.
A person who knows MediPlan president Andrew Strempler said Strempler simply got worn down from fighting. "It was just time to get out to capture as much value as possible," the person said.
The final salvo came this summer when the United States Food and Drug Administration alleged MediPlan and another Internet pharmacy had sold counterfeit drugs into the U.S. Strempler and the Internet pharmacies association vehemently denied the claims. However, MediPlan drug shipments began being seized at the U.S. border.
"The reality is that Andrew Strempler is a man of integrity, and is committed to patient safety and patient care, and the truth of the matter is if a patient can't receive safe and affordable medication on time, then they are at risk," said CanadaDrugs spokesman Troy Harwood-Jones.
So, Strempler phoned friend Kris Thorkelson, CanadaDrugs owner. Although competitors, Strempler and Thorkelson have always maintained a friendship and mutual respect. Initially, Thorkelson agreed to take over just MediPlan's distribution practices so MediPlan drugs could reach patients. That caused the layoff of 15 people in Minnedosa in September. "As things went along, it became obvious it was a great business opportunity" for Thorkelson to purchase all of MediPlan, said Harwood-Jones.
CanadaDrugs is the largest Internet pharmacy in Canada with about 250 employees, and was 50 per cent larger than MediPlan at the time. Jobs have been offered to MediPlan employees, but Harwood-Jones didn't know if anyone had accepted. As for Strempler, he's out of the business he founded. "He's a young guy (about 32) and he's been very successful and I'm very confident he will be very successful again," Harwood-Jones said.
Strempler bought out partners Mark and Chantelle Rzepka in an amicable settlement last year. Phone messages left with Strempler's lawyer requesting an interview with Strempler weren't answered.
MediPlan was highly aggressive from start, taking out pricey full-page ads in major American dailies like the New York Times and publishing complete lists of their cheaper drugs. They also charmed many people along the way. MediPlan customers, mostly American senior citizens with chronic ailments, received their medicines in flowery pastel wrapping, with little handwritten thank-you notes attached -- more like presents at a baby shower. It was the idea of "the girls," Catherine Strempler and Chantelle Rzepka, the wives of the two pharmaceutical degree graduates.
It said much about the foursome: young, naive, energetic, idealistic, respectful, smart. Their employees were nearly all older than they were and the fresh-faced bosses were more apt to treat them like aunts and uncles.
No question, the four original partners in MediPlan walked away multimillionaires. Projections from someone inside the industry suggest MediPlan owners may have made anywhere from $10 million to $30 million. "Anyone worth their salt was making millions of dollars," during the past five years, said the Internet pharmacist, who did not wish to be named.
Mark and Chantelle Rzepka, before their marriage dissolved last year, purchased a new $2-million, 6,800-square-foot home in East St. Paul. Andrew and Catherine Strempler recently purchased Leonard Asper's $2-million, 6,500-square-foot home on Wellington Crescent. But that kind of money also presented life-in-the-fast-lane temptation. Strempler nearly killed himself when he ran his Dodge Viper sports car into a tree on the Yellowhead Highway within Neepawa town limits.
For Minnedosa and the surrounding area, MediPlan's demise is a bit like Dorothy and Toto waking up back in bed in Kansas. Six years ago, MediPlan fell into Minnedosa's lap. No one knew what it was. Almost overnight, it became the area's biggest employer and payroll. Not only were many of the jobs well-paying, but they were "clean jobs," as one person put it, meaning you didn't have dirt under your fingernails at the end of the day.
Minnedosa businesses are bracing for the fallout. Second Century Furniture and Appliance just closed its doors, but it isn't known if MediPlan is a factor. Minnedosa businesses face stiff competition from new big box stores in Brandon.
"It's almost like a gold mine strike," said Minnedosa chief administrator Ken Jenkins. "It's here, and then one day it's gone. But while it was here, it sure was nice."
MediPlan's local philanthropy will also be missed. Robert Dunston, mayor of the town of Neepawa, where the Stremplers still own a house, recalls one time when Andrew Strempler showed up unexpectedly at an annual banquet of the Neepawa Natives of the Manitoba Junior Hockey League.
The banquet always includes a fundraiser where players' sweaters are auctioned off. The auctioneer started off by asking who wanted to give him $1,000 for the first sweater. It was a joke. Sweaters might go for $300 tops.
"I do," Strempler piped up. The room went completely silent. Dunston said it was the first time he'd seen an auctioneer speechless.
However, there is some anger in Minnedosa at the federal government for not doing more to protect their biggest employer.
"The disappointment is it wasn't a business demise. It was political. For Minnedosa, that was the biggest disappointment," said John Mendrikis, who runs John's Tax Service and Accounting in Minnedosa.
Mendrikis added: "The perception out there is that large companies influence policy, and this plays into that."
No, not political. Financial. They took the money and ran.
That, as it turned out, was soooo 2004. Today they going out of business and, well, it’s all about the money. People are losing their jobs – but it doesn’t seem that those who got rich quick are doing anything to help those they led down the primrose path of ill-gotten gains – except maybe letting their former employees wash their fancy cars.
Here’s the story as reported in the Winnipeg Free Press.
MINNEDOSA -- The Internet pharmacy pioneers who gave birth to a half-billion-dollar industry in Canada, most of it in Manitoba, are exiting the industry. MediPlan, founded almost six years ago by four Winnipeg wunderkids ages 21 to 26, will close its doors at the end of this month here, 200 kilometres northwest of Winnipeg. About 75 people are being thrown out of work.
At its peak, MediPlan employed 170 people in Minnedosa. "There's nobody here... We're just winding down," said a woman in the human resources department on the MediPlan's second floor last week.
CanadaDrugs.com in Winnipeg has purchased MediPlan and the jobs will move to the capital city. At least 30 new employees will be needed at CanadaDrugs, a spokesman said. As the industry leader for much of its run, MediPlan, which also goes by RxNorth, had been the prime target for opponents like non-Internet pharmacies, the drug giants, and Canadian and American governments.
A person who knows MediPlan president Andrew Strempler said Strempler simply got worn down from fighting. "It was just time to get out to capture as much value as possible," the person said.
The final salvo came this summer when the United States Food and Drug Administration alleged MediPlan and another Internet pharmacy had sold counterfeit drugs into the U.S. Strempler and the Internet pharmacies association vehemently denied the claims. However, MediPlan drug shipments began being seized at the U.S. border.
"The reality is that Andrew Strempler is a man of integrity, and is committed to patient safety and patient care, and the truth of the matter is if a patient can't receive safe and affordable medication on time, then they are at risk," said CanadaDrugs spokesman Troy Harwood-Jones.
So, Strempler phoned friend Kris Thorkelson, CanadaDrugs owner. Although competitors, Strempler and Thorkelson have always maintained a friendship and mutual respect. Initially, Thorkelson agreed to take over just MediPlan's distribution practices so MediPlan drugs could reach patients. That caused the layoff of 15 people in Minnedosa in September. "As things went along, it became obvious it was a great business opportunity" for Thorkelson to purchase all of MediPlan, said Harwood-Jones.
CanadaDrugs is the largest Internet pharmacy in Canada with about 250 employees, and was 50 per cent larger than MediPlan at the time. Jobs have been offered to MediPlan employees, but Harwood-Jones didn't know if anyone had accepted. As for Strempler, he's out of the business he founded. "He's a young guy (about 32) and he's been very successful and I'm very confident he will be very successful again," Harwood-Jones said.
Strempler bought out partners Mark and Chantelle Rzepka in an amicable settlement last year. Phone messages left with Strempler's lawyer requesting an interview with Strempler weren't answered.
MediPlan was highly aggressive from start, taking out pricey full-page ads in major American dailies like the New York Times and publishing complete lists of their cheaper drugs. They also charmed many people along the way. MediPlan customers, mostly American senior citizens with chronic ailments, received their medicines in flowery pastel wrapping, with little handwritten thank-you notes attached -- more like presents at a baby shower. It was the idea of "the girls," Catherine Strempler and Chantelle Rzepka, the wives of the two pharmaceutical degree graduates.
It said much about the foursome: young, naive, energetic, idealistic, respectful, smart. Their employees were nearly all older than they were and the fresh-faced bosses were more apt to treat them like aunts and uncles.
No question, the four original partners in MediPlan walked away multimillionaires. Projections from someone inside the industry suggest MediPlan owners may have made anywhere from $10 million to $30 million. "Anyone worth their salt was making millions of dollars," during the past five years, said the Internet pharmacist, who did not wish to be named.
Mark and Chantelle Rzepka, before their marriage dissolved last year, purchased a new $2-million, 6,800-square-foot home in East St. Paul. Andrew and Catherine Strempler recently purchased Leonard Asper's $2-million, 6,500-square-foot home on Wellington Crescent. But that kind of money also presented life-in-the-fast-lane temptation. Strempler nearly killed himself when he ran his Dodge Viper sports car into a tree on the Yellowhead Highway within Neepawa town limits.
For Minnedosa and the surrounding area, MediPlan's demise is a bit like Dorothy and Toto waking up back in bed in Kansas. Six years ago, MediPlan fell into Minnedosa's lap. No one knew what it was. Almost overnight, it became the area's biggest employer and payroll. Not only were many of the jobs well-paying, but they were "clean jobs," as one person put it, meaning you didn't have dirt under your fingernails at the end of the day.
Minnedosa businesses are bracing for the fallout. Second Century Furniture and Appliance just closed its doors, but it isn't known if MediPlan is a factor. Minnedosa businesses face stiff competition from new big box stores in Brandon.
"It's almost like a gold mine strike," said Minnedosa chief administrator Ken Jenkins. "It's here, and then one day it's gone. But while it was here, it sure was nice."
MediPlan's local philanthropy will also be missed. Robert Dunston, mayor of the town of Neepawa, where the Stremplers still own a house, recalls one time when Andrew Strempler showed up unexpectedly at an annual banquet of the Neepawa Natives of the Manitoba Junior Hockey League.
The banquet always includes a fundraiser where players' sweaters are auctioned off. The auctioneer started off by asking who wanted to give him $1,000 for the first sweater. It was a joke. Sweaters might go for $300 tops.
"I do," Strempler piped up. The room went completely silent. Dunston said it was the first time he'd seen an auctioneer speechless.
However, there is some anger in Minnedosa at the federal government for not doing more to protect their biggest employer.
"The disappointment is it wasn't a business demise. It was political. For Minnedosa, that was the biggest disappointment," said John Mendrikis, who runs John's Tax Service and Accounting in Minnedosa.
Mendrikis added: "The perception out there is that large companies influence policy, and this plays into that."
No, not political. Financial. They took the money and ran.
Woke up this morning early from a recurring dream. Something to do with suiting up with a new bunch of team mates and an old high school football coach. I want to show them I can still grind out the yardage. No sense of frustration, just hope and confidence.
Don't know what to feel as I see the first headlines of the new year. I careen between frustration and hope about breaking through...not in terms of getting people to agree with what we write here but at least to be more well-rounded and less beholden to the MSM echo chamber.
So here's my opening take on 2007, borne both of hope and frustration. From the Pink Sheet:
Medicaid AMPs May Include More PBM Discounts, If CMS Can Figure Out How
CMS wants to include a broader array of pharmacy benefit manager price concessions in calculating Medicaid average manufacturer prices for reimbursing outpatient prescription drugs.
Compare this lead to the Page One story in the WSJ on the health "middlemen", the final (thankfully) installment of this seris on "Health Care Gold Mines":
"Chicken producer Perdue Farms Inc. used to hire a big health insurer to bargain with doctors. Gradually, over a decade it cut out the middleman, dealing directly with doctors and hospitals just as Wal-Mart Stores Inc. often buys directly from manufacturers instead of using wholesalers. That has helped Perdue keep its health costs below the national average."
Really? How much? Does Perdue have an open or closed formulary. What else is Perdue doing? It just received an award for innovation in health care promotion and prevention. That might have something to with it to especially since drugs are only a small percentage of a health plans cost......
I am waiting for the first Democrat to use Perdue as the example for why Medicare should "negotiate" directly with drug companies. But in fact, government already does negotiate directly with drug companies through Medicaid. It just happens to do than PBMs on most drugs (atypicals seem to be the exception) but CMS can't figure out how to shift Medicaid into the marketplace. And of course no one ever counts the cost of restrictive formularies and prescription limits on Medicaid patients.
So are PBM's saving money or not? Compared to government price controls, the answer is markets move faster and generate discounts more effectively without restricting choice. There's a value to that. The WSJ articles on PBMs glance over the most important point: PBMs are simply paid to save money on drugs, not on health care costs. They are not disease managers and have no stake or ability to prevent or predict disease at an individual level. What's more important: price or value? Do we want to "squeeze" or "eliminate" firms or individuals that can provide such insight? Do we want to replace PBMs with one big government PBM that is just obsessed with drug costs? Then we are back to the Medicaid model and one size fits all drug dispensing and we move away from patient-centric medicine.
Here's another one from the Pink Sheet:
Increasing Clinical Trial Failures Highlighted In GAO Report On Drug R&D
A “systematic analysis†of why drugs fail during clinical testing could help curb the rising number of trial failures and prevent companies from repeating others’ trial mistakes, the Government Accountability Office suggests in a recent report..
Duh.
Peter and I along with a great group of people that formed our 21st Century FDA Task Force (none of whom would have been allowed on the IOM Drug Safety Task Force, include Nobel Prize Winner Josh Lederberg because of conflicts alleged by IOMatrix Sheila Burke) came to that conclusion a year ago as did the FDA with its Critical Path report. And of course a systematic analysis could help reduce the number of rare adverse events in the post market but instead we are going to drink the IOM's kool-aid and spend millions on genomically and phenotypically insensitive claims data that might spot a safety signal years later.
Your PDUFA and tax dollars at work.
Don't know what to feel as I see the first headlines of the new year. I careen between frustration and hope about breaking through...not in terms of getting people to agree with what we write here but at least to be more well-rounded and less beholden to the MSM echo chamber.
So here's my opening take on 2007, borne both of hope and frustration. From the Pink Sheet:
Medicaid AMPs May Include More PBM Discounts, If CMS Can Figure Out How
CMS wants to include a broader array of pharmacy benefit manager price concessions in calculating Medicaid average manufacturer prices for reimbursing outpatient prescription drugs.
Compare this lead to the Page One story in the WSJ on the health "middlemen", the final (thankfully) installment of this seris on "Health Care Gold Mines":
"Chicken producer Perdue Farms Inc. used to hire a big health insurer to bargain with doctors. Gradually, over a decade it cut out the middleman, dealing directly with doctors and hospitals just as Wal-Mart Stores Inc. often buys directly from manufacturers instead of using wholesalers. That has helped Perdue keep its health costs below the national average."
Really? How much? Does Perdue have an open or closed formulary. What else is Perdue doing? It just received an award for innovation in health care promotion and prevention. That might have something to with it to especially since drugs are only a small percentage of a health plans cost......
I am waiting for the first Democrat to use Perdue as the example for why Medicare should "negotiate" directly with drug companies. But in fact, government already does negotiate directly with drug companies through Medicaid. It just happens to do than PBMs on most drugs (atypicals seem to be the exception) but CMS can't figure out how to shift Medicaid into the marketplace. And of course no one ever counts the cost of restrictive formularies and prescription limits on Medicaid patients.
So are PBM's saving money or not? Compared to government price controls, the answer is markets move faster and generate discounts more effectively without restricting choice. There's a value to that. The WSJ articles on PBMs glance over the most important point: PBMs are simply paid to save money on drugs, not on health care costs. They are not disease managers and have no stake or ability to prevent or predict disease at an individual level. What's more important: price or value? Do we want to "squeeze" or "eliminate" firms or individuals that can provide such insight? Do we want to replace PBMs with one big government PBM that is just obsessed with drug costs? Then we are back to the Medicaid model and one size fits all drug dispensing and we move away from patient-centric medicine.
Here's another one from the Pink Sheet:
Increasing Clinical Trial Failures Highlighted In GAO Report On Drug R&D
A “systematic analysis†of why drugs fail during clinical testing could help curb the rising number of trial failures and prevent companies from repeating others’ trial mistakes, the Government Accountability Office suggests in a recent report..
Duh.
Peter and I along with a great group of people that formed our 21st Century FDA Task Force (none of whom would have been allowed on the IOM Drug Safety Task Force, include Nobel Prize Winner Josh Lederberg because of conflicts alleged by IOMatrix Sheila Burke) came to that conclusion a year ago as did the FDA with its Critical Path report. And of course a systematic analysis could help reduce the number of rare adverse events in the post market but instead we are going to drink the IOM's kool-aid and spend millions on genomically and phenotypically insensitive claims data that might spot a safety signal years later.
Your PDUFA and tax dollars at work.
This from China...
Pfizer Inc. won a trademark case in China blocking drugmakers there from copying its Viagra impotence pills' blue diamond shape.
A Beijing court ordered the three companies to pay a $38,000 fine to Pfizer, stop producing the blue, diamond-shaped pills -- which didn't contain the active ingredient in Viagra -- and print a public apology in a Chinese legal newspaper.
(Viagra is known affectionately as "great brother" in China. Obviously lots of folks who purchased the the pill without the active ingredient wound up with "weak sister"instead. )
Now if we can only get Rahm Emanuel, Byron Dorgan, Debbie Stabenow, et al, to print a public apology in an American paper for sponsoring legislation that would encourage these companies to continue producing fake drugs.
Pfizer Inc. won a trademark case in China blocking drugmakers there from copying its Viagra impotence pills' blue diamond shape.
A Beijing court ordered the three companies to pay a $38,000 fine to Pfizer, stop producing the blue, diamond-shaped pills -- which didn't contain the active ingredient in Viagra -- and print a public apology in a Chinese legal newspaper.
(Viagra is known affectionately as "great brother" in China. Obviously lots of folks who purchased the the pill without the active ingredient wound up with "weak sister"instead. )
Now if we can only get Rahm Emanuel, Byron Dorgan, Debbie Stabenow, et al, to print a public apology in an American paper for sponsoring legislation that would encourage these companies to continue producing fake drugs.
Sea Slug Offers Clues to Human Brain Disorders....
Why am I not surprised?
According to an article at livescience.com :
The marine slug has a relatively simple nervous system, with about 10,000 large neurons that can be easily identified, compared with about 100 billion neurons in humans. Even so, the animal is capable of learning and its brain cells communicate in ways identical to human neuron-to-neuron messaging
They found specific genes linked to learning and memory. "We've now identified a whole bunch of receptors for serotonin. So we can see what their function is in various cells and which ones participate in the learning process," Kandel told LiveScience.
The scientists also analyzed 146 human genes implicated in 168 neurological disorders, including Parkinson's and Alzheimer's diseases, and genes controlling aging. They found 104 counterpart genes in Aplysia, suggesting the animal will be a valuable tool in understanding and ultimately treating neurodegenerative diseases."
Why study a sea slug...there are so many members of Congress with even less complex neuron messaging systems that are hardly being used.....but I guess they want to look at a brain that somewhat similar to humans.
And speaking of intellectual sluggishness, this will get the actively ignorant activists at Breast Cancer (In)action launched into another work of junk science....
High-Tech Mammograms Will Change Breast Cancer Care
By Meryl Hyman Harris
HealthDay Reporter
posted: 31 December 2006
11:35 am ET
(HealthDay News) -- The mammogram is changing for the better.
New computer-driven technologies should make the yearly exam more accurate and easier on patients than ever before, experts say.
High-tech computer-based digital mammography is already available at about 10 percent of diagnostic centers in the country and growing steadily at a rate of about 4 percent a month, said Priscilla F. Butler, senior director of the American College of Radiology Breast Imaging Accreditation Programs.
While filmless mammography doesn't feel any different to women while they are being screened, doctors are discovering that there are benefits for particular patients.
A study of more than 40,000 women published last fall found that compared with standard mammograms, computer-based digital "pictures" were more beneficial for more than half the women.
The findings of that study, the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial, were that younger women with dense breast tissue, those under 50 and those who are premenopausal, would benefit most from digital mammograms. The range was so large that some doctors have since concluded that dense breast tissue in all groups is better seen with the help of a computer.
Here's the full article:
http://www.livescience.com/healthday/531925.html
Anti-screening kooks have tried to scare younger women away from mammograms by peddling a hodge-podge of smaller clinical trials in the form of meta-analyses showing no benefit. Well, a meta-analysis of crappy smaller studies is just a large cesspool..which is a perfect place to store Breast Cancer Action's so-called research. The DMIST will break new ground and move us to biomarker based prediction or nano-based prediction which in turn will lead to earlier intervention with private sector developed medicines which will lead to longer lives. THAT will really overwhelm the single cell messaging systems of opponents....
Why am I not surprised?
According to an article at livescience.com :
The marine slug has a relatively simple nervous system, with about 10,000 large neurons that can be easily identified, compared with about 100 billion neurons in humans. Even so, the animal is capable of learning and its brain cells communicate in ways identical to human neuron-to-neuron messaging
They found specific genes linked to learning and memory. "We've now identified a whole bunch of receptors for serotonin. So we can see what their function is in various cells and which ones participate in the learning process," Kandel told LiveScience.
The scientists also analyzed 146 human genes implicated in 168 neurological disorders, including Parkinson's and Alzheimer's diseases, and genes controlling aging. They found 104 counterpart genes in Aplysia, suggesting the animal will be a valuable tool in understanding and ultimately treating neurodegenerative diseases."
Why study a sea slug...there are so many members of Congress with even less complex neuron messaging systems that are hardly being used.....but I guess they want to look at a brain that somewhat similar to humans.
And speaking of intellectual sluggishness, this will get the actively ignorant activists at Breast Cancer (In)action launched into another work of junk science....
High-Tech Mammograms Will Change Breast Cancer Care
By Meryl Hyman Harris
HealthDay Reporter
posted: 31 December 2006
11:35 am ET
(HealthDay News) -- The mammogram is changing for the better.
New computer-driven technologies should make the yearly exam more accurate and easier on patients than ever before, experts say.
High-tech computer-based digital mammography is already available at about 10 percent of diagnostic centers in the country and growing steadily at a rate of about 4 percent a month, said Priscilla F. Butler, senior director of the American College of Radiology Breast Imaging Accreditation Programs.
While filmless mammography doesn't feel any different to women while they are being screened, doctors are discovering that there are benefits for particular patients.
A study of more than 40,000 women published last fall found that compared with standard mammograms, computer-based digital "pictures" were more beneficial for more than half the women.
The findings of that study, the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial, were that younger women with dense breast tissue, those under 50 and those who are premenopausal, would benefit most from digital mammograms. The range was so large that some doctors have since concluded that dense breast tissue in all groups is better seen with the help of a computer.
Here's the full article:
http://www.livescience.com/healthday/531925.html
Anti-screening kooks have tried to scare younger women away from mammograms by peddling a hodge-podge of smaller clinical trials in the form of meta-analyses showing no benefit. Well, a meta-analysis of crappy smaller studies is just a large cesspool..which is a perfect place to store Breast Cancer Action's so-called research. The DMIST will break new ground and move us to biomarker based prediction or nano-based prediction which in turn will lead to earlier intervention with private sector developed medicines which will lead to longer lives. THAT will really overwhelm the single cell messaging systems of opponents....
Es ist nichts schrecklicher als eine thatige Unwissenheit…That’s Goethe for “There is nothing scarier than an active ignorance.â€
I wrote that in response to a post I found something called The Health Care Blog back in July (Here's the link to my post way back then www.drugwonks.com/2006/07/too_many_cancer_drugs.html ) I bring it up as an example of the thinking that provides the left with its rationalization for price controls, restrictive formularies, biased arguments in favor of single payer health system (as in people wait in Europe and Canada cause they are so rural or because they like to wait or have a cultural preference to waiting).
It's the crap -- now applied to deadly illnessess -- that we have way too many drugs that add too little benefit marketed to exploit the sick and dying. And all this dovetails with something friends and acquaintances ask me with surprising regularity:
Don't the drug companies have a cure for cancer or HIV but just don't want to make it available since it would put them out of business?
So drug companies and biotech firms actually spend billions on medicines that fail to make it to market 92 percent of the time because.. Maybe someone could .explain how this fits into the conspiracy theory?
And the genetic tests that help identify which patients will respond best to what treatments... like this most recent test that predicts patients with eye cancer...
"Identifying patients at high risk for metastasis is an important first step toward reducing the death rate of this cancer, which kills nearly half of its patients."
Ocular melanoma attacks the pigment cells in the retina. Earlier studies discovered that patients who are missing one copy of chromosome 3 in their tumor tissue are more likely to have highly aggressive cancers. Half of these patients die within five years, due to metastasis to the liver and other organs.
"When physicians know upfront which patient has a poor prognosis, they will monitor the person more closely to detect metastasis earlier and consider more aggressive treatments to increase their chance of survival, ..Knowledge of metastatic risk will also help patients and their physicians decide whether to pursue clinical trials of experimental therapies that target metastasis."
See New Genetic Test Predicts Risk Of Metastasis In Patients With Deadly Eye Cancer http://www.sciencedaily.com/releases/2006/11/061116100809.htm
Yeah but that means even more cancer drugs. Don't we have enough already?
I wrote that in response to a post I found something called The Health Care Blog back in July (Here's the link to my post way back then www.drugwonks.com/2006/07/too_many_cancer_drugs.html ) I bring it up as an example of the thinking that provides the left with its rationalization for price controls, restrictive formularies, biased arguments in favor of single payer health system (as in people wait in Europe and Canada cause they are so rural or because they like to wait or have a cultural preference to waiting).
It's the crap -- now applied to deadly illnessess -- that we have way too many drugs that add too little benefit marketed to exploit the sick and dying. And all this dovetails with something friends and acquaintances ask me with surprising regularity:
Don't the drug companies have a cure for cancer or HIV but just don't want to make it available since it would put them out of business?
So drug companies and biotech firms actually spend billions on medicines that fail to make it to market 92 percent of the time because.. Maybe someone could .explain how this fits into the conspiracy theory?
And the genetic tests that help identify which patients will respond best to what treatments... like this most recent test that predicts patients with eye cancer...
"Identifying patients at high risk for metastasis is an important first step toward reducing the death rate of this cancer, which kills nearly half of its patients."
Ocular melanoma attacks the pigment cells in the retina. Earlier studies discovered that patients who are missing one copy of chromosome 3 in their tumor tissue are more likely to have highly aggressive cancers. Half of these patients die within five years, due to metastasis to the liver and other organs.
"When physicians know upfront which patient has a poor prognosis, they will monitor the person more closely to detect metastasis earlier and consider more aggressive treatments to increase their chance of survival, ..Knowledge of metastatic risk will also help patients and their physicians decide whether to pursue clinical trials of experimental therapies that target metastasis."
See New Genetic Test Predicts Risk Of Metastasis In Patients With Deadly Eye Cancer http://www.sciencedaily.com/releases/2006/11/061116100809.htm
Yeah but that means even more cancer drugs. Don't we have enough already?
Steve Hofman, my friend, mentor, fellow Yankee fan has come up with the best new health care idea for 2007.
In an article he has written for next week's Busineeweek (Jan 8, 2007) Steve suggests that the way to get Medicare's house in order is not -- as Democrats are demanding -- to impose price controls or restrict access to products or procedures. Rather:
"We need a way to mobilize recipients into an army ready to battle uncontrolled Medicare spending. Remember that modern armies have one thing in common: Members get paid. Every Medicare beneficiary must be paid to be part of the Medicare solution."
Pay seniors to save their own money and control Medicare spending to boot.
How would it work?
"Medicare beneficiaries would receive an annual rebate of 50 cents for each dollars they save the program. If someone saves Medicare $500, she would get $250. For saving Medicare $5000,, a beneficiary would get $2500. It's that simple."
There are right and wrong ways to cut spending. That's the point of Steve's proposal We have been doing all wrong for too long. We never gave seniors incentives to make healthy and economic choices, they same kind we all would make if we were investing our own dollars to pay our own bills.
One gee-whiz number to chew on: "If the 35 million nondisabled Medicare beneficiaries reduced their spending by a mere 5%, then $13.12 billion would be saved annually. And each 1% reduction adds $2.62 billion in further savings..."
That dough would be split 50-50 by seniors and the Treasury.
All the more reason to promote preventive and effective medicine. We haven't even begun to figure out what a combination of diet, exercise, preventive screens and right meds can do for the cost and impact on chronic illness, at least on a personal level. Steve's proposal makes it possible.
In an article he has written for next week's Busineeweek (Jan 8, 2007) Steve suggests that the way to get Medicare's house in order is not -- as Democrats are demanding -- to impose price controls or restrict access to products or procedures. Rather:
"We need a way to mobilize recipients into an army ready to battle uncontrolled Medicare spending. Remember that modern armies have one thing in common: Members get paid. Every Medicare beneficiary must be paid to be part of the Medicare solution."
Pay seniors to save their own money and control Medicare spending to boot.
How would it work?
"Medicare beneficiaries would receive an annual rebate of 50 cents for each dollars they save the program. If someone saves Medicare $500, she would get $250. For saving Medicare $5000,, a beneficiary would get $2500. It's that simple."
There are right and wrong ways to cut spending. That's the point of Steve's proposal We have been doing all wrong for too long. We never gave seniors incentives to make healthy and economic choices, they same kind we all would make if we were investing our own dollars to pay our own bills.
One gee-whiz number to chew on: "If the 35 million nondisabled Medicare beneficiaries reduced their spending by a mere 5%, then $13.12 billion would be saved annually. And each 1% reduction adds $2.62 billion in further savings..."
That dough would be split 50-50 by seniors and the Treasury.
All the more reason to promote preventive and effective medicine. We haven't even begun to figure out what a combination of diet, exercise, preventive screens and right meds can do for the cost and impact on chronic illness, at least on a personal level. Steve's proposal makes it possible.
Thinking back on all the postings Peter and I...posted, it's amazing to consider just how much of a hassle the echo chamber of journalists, politicians and anti-capitalist 'experts' have become to the advance of medical progress.
When you consider the coverage of drug importation, drug safety "issues" such as Ketek or SSRIs, Part D, PDUFA or the release of big government run comparative trials like ALLHAT and CATIE as well as the release of the IOM drug safety report, we at drugwonks are reminded of what Shmuel Goldfish -- Sam Goldwyn -- the head of MGM once said about a particular bad movie his studio produced:
Go see it and see for yourself why you shouldn't go see it.
In general the coverage was objective in the sense that journalists reported what was being fed to them. Given tight deadlines and less space, reporters don't have the luxury of offering perspective or opinion...or do they?
In several instances, articles -- in our opinion -- were clearly written in a way to garner front page placement. That meant objectivity, balance, scientific rigor were sacrificed. That was the case with most coverage regarding Ketek, SSRIs and most recently Zyprexa and the cost of cancer drugs. For the most part, the best coverage on these issues -- the reporting that was comprehensive and balanced -- came from trade publications such as Biocentury, Genome Web, Drug Discovery and Development. Fellow bloggers and newsletters offered more in-depth analysis that was not tainted or spun by the usual suspects, namely Sid "Vicious" Wolfe.
Our point of view is clear: let science shape policy and guide decisions in a transparent fashion. Give patients and regulators the tools to make medicine predictive, personalized and prospective. We are tired of the either-or debate about formularies, DTC, pricing. Science and informatics is allowing us to move away from such obtuse choices. As Janet Woodcock, the Mother Courage of personalized medicine, has put it: medicine is no longer a matter of running studies to determine whether everyone should get drug A or drug B. It's a matter of developing tools to help people decide who gets drug A and who gets drug B.
Indeed, I am awaiting the results of a new genetic test to determine which statin will work best for me. No more trial and error, no more running to the doctor's office after one side effect after another. And imagine what it means for drug advertising when mass marketing of medicines doesn't matter or when one size fits all guidelines become even less relevant?
But I digress. In general the inability to place discussion of these contentious issues in context of where medical science is heading has contributed to public misunderstanding and poor policy.
Which is why I beat up on the IOM drug safety report so consistently. The report fails to look at post market surveillance as part of a complete feedback system for information that includes drug researchers and patients. It fails to integrate the scientific tools of the critical path and the emergence of personalized medicine into it;'s discussion and offers America more data dredging of little value. The IOM drug safety committe is a group of false prophets peddling 19th century solutions to 21st century challenges.
Drugwonks will provide alternatives that, unlike the IOM recommendations, will promote patient safety in real time, won't strangle drug development and discourage the best and brightest from advising the FDA.
And we will seek to provide the scientific foundation -- and personalized medicine viewpoint -- of any healthcare policy issue.
As we move ahead we will be guided by what Eric Hoffer noted about adapting in a era of turmoil and transition:
"In times of change, learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists."
When you consider the coverage of drug importation, drug safety "issues" such as Ketek or SSRIs, Part D, PDUFA or the release of big government run comparative trials like ALLHAT and CATIE as well as the release of the IOM drug safety report, we at drugwonks are reminded of what Shmuel Goldfish -- Sam Goldwyn -- the head of MGM once said about a particular bad movie his studio produced:
Go see it and see for yourself why you shouldn't go see it.
In general the coverage was objective in the sense that journalists reported what was being fed to them. Given tight deadlines and less space, reporters don't have the luxury of offering perspective or opinion...or do they?
In several instances, articles -- in our opinion -- were clearly written in a way to garner front page placement. That meant objectivity, balance, scientific rigor were sacrificed. That was the case with most coverage regarding Ketek, SSRIs and most recently Zyprexa and the cost of cancer drugs. For the most part, the best coverage on these issues -- the reporting that was comprehensive and balanced -- came from trade publications such as Biocentury, Genome Web, Drug Discovery and Development. Fellow bloggers and newsletters offered more in-depth analysis that was not tainted or spun by the usual suspects, namely Sid "Vicious" Wolfe.
Our point of view is clear: let science shape policy and guide decisions in a transparent fashion. Give patients and regulators the tools to make medicine predictive, personalized and prospective. We are tired of the either-or debate about formularies, DTC, pricing. Science and informatics is allowing us to move away from such obtuse choices. As Janet Woodcock, the Mother Courage of personalized medicine, has put it: medicine is no longer a matter of running studies to determine whether everyone should get drug A or drug B. It's a matter of developing tools to help people decide who gets drug A and who gets drug B.
Indeed, I am awaiting the results of a new genetic test to determine which statin will work best for me. No more trial and error, no more running to the doctor's office after one side effect after another. And imagine what it means for drug advertising when mass marketing of medicines doesn't matter or when one size fits all guidelines become even less relevant?
But I digress. In general the inability to place discussion of these contentious issues in context of where medical science is heading has contributed to public misunderstanding and poor policy.
Which is why I beat up on the IOM drug safety report so consistently. The report fails to look at post market surveillance as part of a complete feedback system for information that includes drug researchers and patients. It fails to integrate the scientific tools of the critical path and the emergence of personalized medicine into it;'s discussion and offers America more data dredging of little value. The IOM drug safety committe is a group of false prophets peddling 19th century solutions to 21st century challenges.
Drugwonks will provide alternatives that, unlike the IOM recommendations, will promote patient safety in real time, won't strangle drug development and discourage the best and brightest from advising the FDA.
And we will seek to provide the scientific foundation -- and personalized medicine viewpoint -- of any healthcare policy issue.
As we move ahead we will be guided by what Eric Hoffer noted about adapting in a era of turmoil and transition:
"In times of change, learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists."
Excellent series of papers on the the relationship between obesity, diabetes, heart disease, inflammation, etc....the genetic and cellular mechanisms that control all and the variations thereof.
Here's the link..
http://www.nature.com/nature/supplements/insights/dia_obe_age/index.html
Oh wait, the supplement produced by Nature was sponsored by Nestle's the food conglomerate. Probably can't trust it...Must be some sort of conspiracy to make us think that gorging on hot chocolate and Nestle's Quik won't lead to weight gain...scrap it...I am sure Arnie Relman, Jerry Kassirer and everyone else who made their money selling reprints to drug companies wouldn't approve..
Here's the link..
http://www.nature.com/nature/supplements/insights/dia_obe_age/index.html
Oh wait, the supplement produced by Nature was sponsored by Nestle's the food conglomerate. Probably can't trust it...Must be some sort of conspiracy to make us think that gorging on hot chocolate and Nestle's Quik won't lead to weight gain...scrap it...I am sure Arnie Relman, Jerry Kassirer and everyone else who made their money selling reprints to drug companies wouldn't approve..
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
