Latest Drugwonks' Blog
Here's the gift that will keep on giving...
From the LA Times round up of the year's top ten scams...
"Natural" Viagra turned out to be not so natural in some cases.
Some over-the-counter supplements, with names as unsubtle as 4Everon, claimed to remedy erectile dysfunction as effectively as the prescription drug.
The Food and Drug Administration found that they indeed did their job well. But that was because the active ingredient in the concoctions was the same as in real Viagra.
The scam could have serious consequences because the "supplements" posed health problems if mixed with drugs taken for diabetes and other conditions.
The FDA forced 4Everon off the market."
As for names...I still like the Chinese rip-off of Viagra name...Big Brother
http://www.latimes.com/business/la-fi-consumer16dec16,1,2647940.story?coll=la-headlines-business
From the LA Times round up of the year's top ten scams...
"Natural" Viagra turned out to be not so natural in some cases.
Some over-the-counter supplements, with names as unsubtle as 4Everon, claimed to remedy erectile dysfunction as effectively as the prescription drug.
The Food and Drug Administration found that they indeed did their job well. But that was because the active ingredient in the concoctions was the same as in real Viagra.
The scam could have serious consequences because the "supplements" posed health problems if mixed with drugs taken for diabetes and other conditions.
The FDA forced 4Everon off the market."
As for names...I still like the Chinese rip-off of Viagra name...Big Brother
http://www.latimes.com/business/la-fi-consumer16dec16,1,2647940.story?coll=la-headlines-business
On the Presidential election and drug importation as a "hickory stick" to beat the pharmaceutical industry.
Download file
The article's conclusion says it all:
"The facts are not important. This is all about rhetoric. The facts against drug importation as sound health care policy are enormous. The argument for drug importation are political and rhetorical."
Download file
The article's conclusion says it all:
"The facts are not important. This is all about rhetoric. The facts against drug importation as sound health care policy are enormous. The argument for drug importation are political and rhetorical."
From the pages of the Boston Globe …
Judge shoots down Maine law curbing access to prescription data
BANGOR, Maine—Relying heavily on a ruling in New Hampshire, a federal judge has overturned a new state law that restricts access by medical data companies to doctors' prescription information.
U.S. District Judge John Woodcock concluded that the law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment."
Here’s the rest of the story:
http://www.boston.com/news/local/maine/articles/2007/12/22/judge_shoots_down_maine_law_curbing_access_to_prescription_data/
In addition to First Amendment issues, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.
When it comes to public health trumping politics -- remember the Maine verdict.
Judge shoots down Maine law curbing access to prescription data
BANGOR, Maine—Relying heavily on a ruling in New Hampshire, a federal judge has overturned a new state law that restricts access by medical data companies to doctors' prescription information.
U.S. District Judge John Woodcock concluded that the law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment."
Here’s the rest of the story:
http://www.boston.com/news/local/maine/articles/2007/12/22/judge_shoots_down_maine_law_curbing_access_to_prescription_data/
In addition to First Amendment issues, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.
When it comes to public health trumping politics -- remember the Maine verdict.
Hey Michael, I thought this happened only in America
Japanese woman dies searching for care
By CHISAKI WATANABE, Associated Press Writer 37 minutes ago
TOKYO - An 89-year-old woman died after an ambulance crew spent two hours trying 30 hospitals before finding one that would accept her for treatment, Japanese officials said Friday.
http://news.yahoo.com/s/ap/20071228/ap_on_re_as/japan_ambulance_deat
Japanese woman dies searching for care
By CHISAKI WATANABE, Associated Press Writer 37 minutes ago
TOKYO - An 89-year-old woman died after an ambulance crew spent two hours trying 30 hospitals before finding one that would accept her for treatment, Japanese officials said Friday.
http://news.yahoo.com/s/ap/20071228/ap_on_re_as/japan_ambulance_deat
The following article could have been written in any election cycle ...
Pocketbook worries outweigh voters' concerns over war in Iraq
By JIM KUHNHENN and TREVOR TOMPSON, Associated Press Writers
WASHINGTON (AP) — Voters began to worry more about their pocketbooks over the last month — even more than about the war in Iraq....
"...This latest AP-Yahoo! News survey of more than 1,800 people by Knowledge Networks offers a unique opportunity to track changes in public attitudes as the presidential campaign unfolds. The first poll was last month and set a base line to measure national sentiment.
In the new results, men and women approaching retirement were especially attentive to the economy and health care, with six out of 10 ranking both issues extremely important. Politically, the attention to such domestic issues hangs darkly over Republicans. Voters say they are far more likely to trust Democrats to handle the economy and health care."
Consider Linda Zimmerman, a 50-year-old sheep farmer from Thurmont, Md. Her daughter and son-in-law are having trouble keeping up with two mortgages on a town house, she said. One street in her neighborhood has five homes for sale, and one has been on the market for two years.
Registered as a Republican, she's ready to reconsider.
"We're Republicans and I'm very unhappy with them, and I've been watching the Democrats," she said. "We did better when (Bill) Clinton was in than we did with Bush. It's just terrible."
Terrible? Aren't things going better in Iraq? Wasn't that the real downer in America according to the media just a couple of months ago? And how did they ever find a sheep farmer in Thurmont, Md?
As 2008 and the election year approaches, there is really nothing new in the political playbook. For the Dems and the media worse is always better and the good news is always in the past.
http://news.yahoo.com/page/election-2008-political-pulse-voter-worries
Pocketbook worries outweigh voters' concerns over war in Iraq
By JIM KUHNHENN and TREVOR TOMPSON, Associated Press Writers
WASHINGTON (AP) — Voters began to worry more about their pocketbooks over the last month — even more than about the war in Iraq....
"...This latest AP-Yahoo! News survey of more than 1,800 people by Knowledge Networks offers a unique opportunity to track changes in public attitudes as the presidential campaign unfolds. The first poll was last month and set a base line to measure national sentiment.
In the new results, men and women approaching retirement were especially attentive to the economy and health care, with six out of 10 ranking both issues extremely important. Politically, the attention to such domestic issues hangs darkly over Republicans. Voters say they are far more likely to trust Democrats to handle the economy and health care."
Consider Linda Zimmerman, a 50-year-old sheep farmer from Thurmont, Md. Her daughter and son-in-law are having trouble keeping up with two mortgages on a town house, she said. One street in her neighborhood has five homes for sale, and one has been on the market for two years.
Registered as a Republican, she's ready to reconsider.
"We're Republicans and I'm very unhappy with them, and I've been watching the Democrats," she said. "We did better when (Bill) Clinton was in than we did with Bush. It's just terrible."
Terrible? Aren't things going better in Iraq? Wasn't that the real downer in America according to the media just a couple of months ago? And how did they ever find a sheep farmer in Thurmont, Md?
As 2008 and the election year approaches, there is really nothing new in the political playbook. For the Dems and the media worse is always better and the good news is always in the past.
http://news.yahoo.com/page/election-2008-political-pulse-voter-worries
Book argues that Bell stole phone idea (AP)
BOSTON - A new book claims to have definitive evidence of a long-suspected technological crime — that Alexander Graham Bell stole ideas for the telephone from a rival, Elisha Gray.
http://tech.yahoo.com/news/ap/techbit_bell_book
BOSTON - A new book claims to have definitive evidence of a long-suspected technological crime — that Alexander Graham Bell stole ideas for the telephone from a rival, Elisha Gray.
http://tech.yahoo.com/news/ap/techbit_bell_book
Consider the story of Eric Lester, an oncologist in St. Joseph, Michigan, who was trying to find a way save the lives of his patients with advanced lung cancer. Instead of waiting for someone else to develop diagnostic tools, Lester developed his own test to see what kind of genetic factors were causing the cancer to grow. It turned out that epidermal growth factor receptor was the culprit and that a drug called Tarceva, designed to shut off that receptor, would work.
Instead of waiting to use Tarceva when all else was failing, he decided to use it as part of a tailor-made drug cocktail for his patient based on the information from the diagnostic he developed while staying within the bounds of the FDA. The patient fared better than most of the patients Lester sees.
It’s not a cure, but the results of Lester’s experiment—and others like it—are being shared with academic researchers and drug companies to accelerate the development of cancer drugs tailored to variations of growth factors causing lung cancer. Patients like Lester’s would receive tests that look for biomarkers—biochemical indicators of a disease—to see which drug would work best with fewest side effects. Such collaboration could bring about a new generation of cancer-killing treatments in years.
For more check out the Journal of Life Sciences at:
http://www.tjols.com/article-482.html
And that will explain the title.
Instead of waiting to use Tarceva when all else was failing, he decided to use it as part of a tailor-made drug cocktail for his patient based on the information from the diagnostic he developed while staying within the bounds of the FDA. The patient fared better than most of the patients Lester sees.
It’s not a cure, but the results of Lester’s experiment—and others like it—are being shared with academic researchers and drug companies to accelerate the development of cancer drugs tailored to variations of growth factors causing lung cancer. Patients like Lester’s would receive tests that look for biomarkers—biochemical indicators of a disease—to see which drug would work best with fewest side effects. Such collaboration could bring about a new generation of cancer-killing treatments in years.
For more check out the Journal of Life Sciences at:
http://www.tjols.com/article-482.html
And that will explain the title.
From The Times of London ...
Hospitals fight NHS ban on patients using private drugs
Sarah-Kate Templeton, Health Editor
HOSPITAL chiefs are demanding an urgent review of the government’s policy of withdrawing National Health Service care from patients who pay privately for additional cancer medicines.
The NHS Confederation, which represents hospital chief executives and managers, says denying NHS treatment to patients who pay for top-up drugs is “perverse†and against “common senseâ€.
The move comes after it emerged that women suffering from breast cancer have been threatened with losing NHS care if they seek to improve their chances by paying privately for an extra drug.
Ministers claim that to allow patients to pay for top-up drugs would be unfair on those who cannot afford them and lead to a two-tier NHS. Their policy was laid down in guidance issued this summer but was criticised last week after The Sunday Times highlighted the case of Colette Mills, 58, from near Stokesley, North Yorkshire.
Mills, a former nurse, has been told that if she pays for the cancer drug Avastin, which the NHS does not fund, she will have to foot the £10,000 total monthly bill for her care.
Another breast cancer patient, Debbie Hirst, 56, from St Ives, Cornwall, has now revealed that she, too, has been told that if she wants to pay for Avastin in addition to her NHS medicines, she will be forced to pay for all her care.
The Royal Cornwall Hospitals NHS Trust issued the threat despite three other patients being allowed to top up their NHS care. The trust says the three had started their private treatment before the guidance was issued.
Hirst, a grandmother, said: “We put our house up for sale in order to pay for this drug. My only option now is to take the treatment they offer on the NHS or go private, which would be totally unaffordable.â€
Nigel Edwards, the NHS Confederation’s director of policy, said: “The position appears to run counter to common sense. This should ring alarm bells that something is wrong with the policy.â€
Edwards said patients are already regularly combining private and NHS care. For example, thousands mix NHS dental care with treatments available only privately.
Co-payments should be allowed, he said, provided they did not deprive other patients of resources, and those paying for the drugs are well informed of their limitations.
It was also reported yesterday that a 62-year-old woman had won a legal battle for the right to be treated with Avastin for bowel cancer. She will pay for the drug while Cumbria Primary Care Trust funds the rest of her care.
Mills and Hirst are to launch a campaign for all patients to have the right to pay for medicines not funded on the NHS. They are backed by the Patients Association, Doctors for Reform and Saga, the organisation for the over-fifties.
Andrew Goodsell, Saga chief executive, said: “People are less concerned about a two-tier health service than whether they have the opportunity to resolve what can be a life or death situation.â€
The health department said: “It is a fundamental principle of the NHS, supported by all the main political parties, that treatment should be free at the point of need. Co-payments would undermine this.â€
Hospitals fight NHS ban on patients using private drugs
Sarah-Kate Templeton, Health Editor
HOSPITAL chiefs are demanding an urgent review of the government’s policy of withdrawing National Health Service care from patients who pay privately for additional cancer medicines.
The NHS Confederation, which represents hospital chief executives and managers, says denying NHS treatment to patients who pay for top-up drugs is “perverse†and against “common senseâ€.
The move comes after it emerged that women suffering from breast cancer have been threatened with losing NHS care if they seek to improve their chances by paying privately for an extra drug.
Ministers claim that to allow patients to pay for top-up drugs would be unfair on those who cannot afford them and lead to a two-tier NHS. Their policy was laid down in guidance issued this summer but was criticised last week after The Sunday Times highlighted the case of Colette Mills, 58, from near Stokesley, North Yorkshire.
Mills, a former nurse, has been told that if she pays for the cancer drug Avastin, which the NHS does not fund, she will have to foot the £10,000 total monthly bill for her care.
Another breast cancer patient, Debbie Hirst, 56, from St Ives, Cornwall, has now revealed that she, too, has been told that if she wants to pay for Avastin in addition to her NHS medicines, she will be forced to pay for all her care.
The Royal Cornwall Hospitals NHS Trust issued the threat despite three other patients being allowed to top up their NHS care. The trust says the three had started their private treatment before the guidance was issued.
Hirst, a grandmother, said: “We put our house up for sale in order to pay for this drug. My only option now is to take the treatment they offer on the NHS or go private, which would be totally unaffordable.â€
Nigel Edwards, the NHS Confederation’s director of policy, said: “The position appears to run counter to common sense. This should ring alarm bells that something is wrong with the policy.â€
Edwards said patients are already regularly combining private and NHS care. For example, thousands mix NHS dental care with treatments available only privately.
Co-payments should be allowed, he said, provided they did not deprive other patients of resources, and those paying for the drugs are well informed of their limitations.
It was also reported yesterday that a 62-year-old woman had won a legal battle for the right to be treated with Avastin for bowel cancer. She will pay for the drug while Cumbria Primary Care Trust funds the rest of her care.
Mills and Hirst are to launch a campaign for all patients to have the right to pay for medicines not funded on the NHS. They are backed by the Patients Association, Doctors for Reform and Saga, the organisation for the over-fifties.
Andrew Goodsell, Saga chief executive, said: “People are less concerned about a two-tier health service than whether they have the opportunity to resolve what can be a life or death situation.â€
The health department said: “It is a fundamental principle of the NHS, supported by all the main political parties, that treatment should be free at the point of need. Co-payments would undermine this.â€
Soldiers, that is, on behalf of the public health.
From the pages of the Buffalo News ...
Innovation can’t survive without ownership
By Peter Pitts
If you wrote a book, would you be happy to see it published under someone else’s name?
What if you spent several years of your life — and invested a large chunk of your savings — developing a new product that made life easier for you and your family? Would you regret having done so if it became “public property†at the stroke of a lawmaker’s pen?
It would probably be the end of your inventing career.
Yet when it comes to lifesaving drugs and treatments, some seem to believe that the rules of human nature and economic reality don’t apply.
In Thailand, the military-appointed government has granted the stateowned Government Pharmaceutical Organization (GPO) the authority to produce generic versions of several patented medicines. The Thai government has claimed that its goal is to provide these drugs to poor Thais, but in reality, government leaders are hoping that the GPO will become a new and highly profitable hub for the manufacture and export of all manner of copycat drugs.
Amazingly, such actions are supported by public health activists and nongovernmental organizations. Earlier this month, representatives from Doctors without Borders, Oxfam International and other organizations defended the Thai junta’s actions at a conference on drug patents held in Thailand.
And earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for the Thai government’s renegade action. But history demonstrates the folly of such actions.
In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death†in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.
In other words, even if the elimination of patent rights makes drugs less costly, it doesn’t produce greater access.
There is a reason why virtually all the world’s “miracle drugs†have been developed in Western countries. It’s called incentive. Because innovation is honored and protected, inventors are rewarded for their work.
Unfortunately, once a lifesaving drug or treatment exists, it’s seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality.
And because we need it, we expect it to be free. But if we allow our emotions to trump reason, and cloud our minds to the realities of human nature and economics 101, we’ll end up with a lot less innovation.
And fewer lifesaving drugs to take for granted.
From the pages of the Buffalo News ...
Innovation can’t survive without ownership
By Peter Pitts
If you wrote a book, would you be happy to see it published under someone else’s name?
What if you spent several years of your life — and invested a large chunk of your savings — developing a new product that made life easier for you and your family? Would you regret having done so if it became “public property†at the stroke of a lawmaker’s pen?
It would probably be the end of your inventing career.
Yet when it comes to lifesaving drugs and treatments, some seem to believe that the rules of human nature and economic reality don’t apply.
In Thailand, the military-appointed government has granted the stateowned Government Pharmaceutical Organization (GPO) the authority to produce generic versions of several patented medicines. The Thai government has claimed that its goal is to provide these drugs to poor Thais, but in reality, government leaders are hoping that the GPO will become a new and highly profitable hub for the manufacture and export of all manner of copycat drugs.
Amazingly, such actions are supported by public health activists and nongovernmental organizations. Earlier this month, representatives from Doctors without Borders, Oxfam International and other organizations defended the Thai junta’s actions at a conference on drug patents held in Thailand.
And earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for the Thai government’s renegade action. But history demonstrates the folly of such actions.
In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death†in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.
In other words, even if the elimination of patent rights makes drugs less costly, it doesn’t produce greater access.
There is a reason why virtually all the world’s “miracle drugs†have been developed in Western countries. It’s called incentive. Because innovation is honored and protected, inventors are rewarded for their work.
Unfortunately, once a lifesaving drug or treatment exists, it’s seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality.
And because we need it, we expect it to be free. But if we allow our emotions to trump reason, and cloud our minds to the realities of human nature and economics 101, we’ll end up with a lot less innovation.
And fewer lifesaving drugs to take for granted.
From the pages of FDA News ...
Critical Path Wants Adaptive Clinical Trial Designs, Temple Says
The FDA is encouraging the use of adaptive trials, saying the practice will modernize the development process and shorten the time needed to show a drug is effective. The agency’s associate director for medical policy, Robert Temple, said the Critical Path Initiative encourages the use of this kind of trial when researchers use accumulating data to modify the ongoing trial. Temple, speaking at the Critical Path Executive Briefing sponsored by FDAnews and the Center for Medicine in the Public Interest, said the FDA is working on an adaptive design guidance it promised to release in 2008.
Some of the more familiar adaptations include changing sample sizes based on variance and starting and dropping extra trial groups. When researchers determine a drug effect is present in a population subset, they can adapt the trial by modifying the trial’s entry criteria or increasing the number of patients assigned to receive the effective treatment.
While almost every clinical trial uses enrichment in some way to improve the trial’s patient population, there are more steps that can be taken to increase the chances a drug effect is detected, Temple said. Some enrichment efforts can decrease variants while others can choose high-risk patients or patients more likely to respond to treatment because of some genetic characteristic.
“Everyone agrees about finding the people who are most likely to respond … it enormously enhances the power of the study,†Temple said. Enrichment will help researchers by decreasing heterogeneity and identifying a population that responds to the treatment.
For example, researchers can screen patients with the treatment first and then enroll them in the study if they respond to the drug. In addition, researchers can study a large group of patients and only randomize those with a good response.
Scientists are beginning to be able to search for genetic characteristics or other factors that will predict a patient’s response to a drug, Temple said. Part of the Critical Path Initiative is to identify biomarkers and determine why some patients and not others experience adverse events with the same drug.
Researchers can select trial subjects based on either understanding of a disease or a drug mechanism, but they also can run a trial in patients to link a genetic baseline finding with a drug response, Temple added.
Critical Path Wants Adaptive Clinical Trial Designs, Temple Says
The FDA is encouraging the use of adaptive trials, saying the practice will modernize the development process and shorten the time needed to show a drug is effective. The agency’s associate director for medical policy, Robert Temple, said the Critical Path Initiative encourages the use of this kind of trial when researchers use accumulating data to modify the ongoing trial. Temple, speaking at the Critical Path Executive Briefing sponsored by FDAnews and the Center for Medicine in the Public Interest, said the FDA is working on an adaptive design guidance it promised to release in 2008.
Some of the more familiar adaptations include changing sample sizes based on variance and starting and dropping extra trial groups. When researchers determine a drug effect is present in a population subset, they can adapt the trial by modifying the trial’s entry criteria or increasing the number of patients assigned to receive the effective treatment.
While almost every clinical trial uses enrichment in some way to improve the trial’s patient population, there are more steps that can be taken to increase the chances a drug effect is detected, Temple said. Some enrichment efforts can decrease variants while others can choose high-risk patients or patients more likely to respond to treatment because of some genetic characteristic.
“Everyone agrees about finding the people who are most likely to respond … it enormously enhances the power of the study,†Temple said. Enrichment will help researchers by decreasing heterogeneity and identifying a population that responds to the treatment.
For example, researchers can screen patients with the treatment first and then enroll them in the study if they respond to the drug. In addition, researchers can study a large group of patients and only randomize those with a good response.
Scientists are beginning to be able to search for genetic characteristics or other factors that will predict a patient’s response to a drug, Temple said. Part of the Critical Path Initiative is to identify biomarkers and determine why some patients and not others experience adverse events with the same drug.
Researchers can select trial subjects based on either understanding of a disease or a drug mechanism, but they also can run a trial in patients to link a genetic baseline finding with a drug response, Temple added.
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.
