Latest Drugwonks' Blog
I am preparing for my very first colonoscopy today. Scheduled for tomorrow morning at 10 am. I am looking at it as getting done to me what Democrats will do to seniors and medical progress if they win control of Congress and get a hold of Medicare.
Very important story by Steve Usdin in this week's edition of BioCentury.
The first paragraph sets the stage:
"FDA's rejection of Replidyne Inc.'s farapenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections. But the absence of agency guidance forces developers to guess what protocols might work, a burden industry may not choose to take on despite the fact that the U.S. spends $8.5 billion on oral antibiotics in the U.S. annually."
And further ...
"The agency's action reflects arguments that the effectiveness of comparator antibiotics has not been established against placebo, making a non-inferiority result of doubtful value. And with the exception of CAP (community-acquired pneumonia), where the role an antibiotics isn't questioned and where FDA will still accept non-inferiority studies, the other indications are self-limiting, and thus the urgency to treat is said to be lower."
Many issues here, not the least of which are the ethical implications. As Usdin points out, "By requiring superiority trials in ABS (acute bacterial sinusitis) and AECB (acute exacerbation of chronic bronchitis), FDA has taken sides in a debate among clinicians, academic researchers, politicians and industry over whether it is necessary, ethical, or possible to conduct such trials."
On one side is Donald Poretz, Georgetown School of Medicine and a member of the FDA's Anti-Infective Drugs adcomm, "For years we thought is was unethical to do placebo-controlled trials in sinusitis, bronchitis, and otitis media, but now it seems it is ethical" ... because it isn't clear that antibiotics are helpful.
On the other side, James Hadley, University of Rochester Medical Center and past president of the American Academy of Otolaryngology, "It is very difficult in the U.S. under current law and regulations, and with IRBs that regulate clinical trials to offer a placebo to patients in view of an active disease process."
Show me the guidance!
The first paragraph sets the stage:
"FDA's rejection of Replidyne Inc.'s farapenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections. But the absence of agency guidance forces developers to guess what protocols might work, a burden industry may not choose to take on despite the fact that the U.S. spends $8.5 billion on oral antibiotics in the U.S. annually."
And further ...
"The agency's action reflects arguments that the effectiveness of comparator antibiotics has not been established against placebo, making a non-inferiority result of doubtful value. And with the exception of CAP (community-acquired pneumonia), where the role an antibiotics isn't questioned and where FDA will still accept non-inferiority studies, the other indications are self-limiting, and thus the urgency to treat is said to be lower."
Many issues here, not the least of which are the ethical implications. As Usdin points out, "By requiring superiority trials in ABS (acute bacterial sinusitis) and AECB (acute exacerbation of chronic bronchitis), FDA has taken sides in a debate among clinicians, academic researchers, politicians and industry over whether it is necessary, ethical, or possible to conduct such trials."
On one side is Donald Poretz, Georgetown School of Medicine and a member of the FDA's Anti-Infective Drugs adcomm, "For years we thought is was unethical to do placebo-controlled trials in sinusitis, bronchitis, and otitis media, but now it seems it is ethical" ... because it isn't clear that antibiotics are helpful.
On the other side, James Hadley, University of Rochester Medical Center and past president of the American Academy of Otolaryngology, "It is very difficult in the U.S. under current law and regulations, and with IRBs that regulate clinical trials to offer a placebo to patients in view of an active disease process."
Show me the guidance!
While looking for a white paper on the WHO website I was surprised, excited, and pleased to see that their updated fact sheet on counterfeit drugs cites CMPI on the projected growth of global sales of fake medicines.
Here's the precise citation:
"The Centre for Medicine in the Public Interest, in the United States, predicts that counterfeit drug sales will reach US$75 globally in 2010, an increase of more than 90% from 2005."
So, now that we've given ourselves a nice pat on the back (and don't you love the quaint spelling of "Centre"), it's important to pass along the link for the WHO fact sheet. It's an important reference.
Have a look:
http://www.who.int/mediacentre/factsheets/fs275/en/print.html
Here's the precise citation:
"The Centre for Medicine in the Public Interest, in the United States, predicts that counterfeit drug sales will reach US$75 globally in 2010, an increase of more than 90% from 2005."
So, now that we've given ourselves a nice pat on the back (and don't you love the quaint spelling of "Centre"), it's important to pass along the link for the WHO fact sheet. It's an important reference.
Have a look:
http://www.who.int/mediacentre/factsheets/fs275/en/print.html
Want to know what happens when the NIH toes the conflict free holier than thou line espoused by Marcia Angell, JAMA, NEJM.....
"Ethics rules send NIH scientists packing
By RITA BEAMISH, Associated Press WriterSat Oct 28, 6:06 PM ET
Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income.
Most scientists say the ethics crackdown is too severe, and nearly three-quarters of them believe it will hinder the government's ability to attract and keep medical researchers, according to a survey commissioned by the government's premier medical research agency.
The tightened rules were put in place last year after NIH found dozens of scientists had run afoul of existing restrictions on private consulting deals that had enriched them with money from drug and biotechnology companies.
Outside income from such companies is now banned. NIH also is placing greater restrictions and disclosure requirements on employees' financial holdings....."
What's so delicious about all this is Jim Greenwood, now chairman of BIO was one of the Congressman who beat up NIH on this COI issue. Now BIO is bemoaning the fact that NIH is losing the smartest people, particularly at NCI and testified before the NIH Blue Ribbon Panel on conflict of interest against the very limits that are sending scientists packing.
And if you think it's bad now, just wait till Dingell and Waxman get control of the relevant committees....Fewer scientists conducting less research in cooperation with scientists in academia and companies in such areas as stem cell research, Alzheimer's, cancer, etc. That means less investment in these critical areas and less progress. Way to go.
"Ethics rules send NIH scientists packing
By RITA BEAMISH, Associated Press WriterSat Oct 28, 6:06 PM ET
Nearly 40 percent of the scientists conducting hands-on research at the National Institutes of Health say they are looking for other jobs or are considering doing so to escape new ethics rules that have curtailed their opportunity to earn outside income.
Most scientists say the ethics crackdown is too severe, and nearly three-quarters of them believe it will hinder the government's ability to attract and keep medical researchers, according to a survey commissioned by the government's premier medical research agency.
The tightened rules were put in place last year after NIH found dozens of scientists had run afoul of existing restrictions on private consulting deals that had enriched them with money from drug and biotechnology companies.
Outside income from such companies is now banned. NIH also is placing greater restrictions and disclosure requirements on employees' financial holdings....."
What's so delicious about all this is Jim Greenwood, now chairman of BIO was one of the Congressman who beat up NIH on this COI issue. Now BIO is bemoaning the fact that NIH is losing the smartest people, particularly at NCI and testified before the NIH Blue Ribbon Panel on conflict of interest against the very limits that are sending scientists packing.
And if you think it's bad now, just wait till Dingell and Waxman get control of the relevant committees....Fewer scientists conducting less research in cooperation with scientists in academia and companies in such areas as stem cell research, Alzheimer's, cancer, etc. That means less investment in these critical areas and less progress. Way to go.
When it comes to improving postmarketing surveillance there are a few acronyms to keep in mind: FDA, MIT, and AEGIS.
Note to publicity hungry politicians, pundits, and Prophets of the Precautionary Principle: One acronym not mentioned above (or in the important article below) is"CYA."
Have a look and see what real progress looks like:
Download file
Note to publicity hungry politicians, pundits, and Prophets of the Precautionary Principle: One acronym not mentioned above (or in the important article below) is"CYA."
Have a look and see what real progress looks like:
Download file
My oped today in the NY Dailly News nydailynews.com
End sick crusade against breast cancer research
By ROBERT GOLDBERG
Saturday, October 28th, 2006
Every October, as Breast Cancer Awareness Month rolls around, we wear pink ribbons and focus our attention on a terrible disease that takes the lives of some 40,000 American women every year. But this year, a group known as Breast Cancer Action has seized the stage - and, claiming to speak on behalf of breast cancer patients themselves, is making conspiratorial, offensive and irresponsible statements. They must be exposed as the fearmongers they are.
In a national media campaign that includes newspaper and TV ads, the upstart organization is advising women to "think before you pink" because - get this - they consider corporate donations to fight cancer research tainted by the profit motive. The group warns women against the breakthrough treatments corporate-funded research might yield.
And most alarmingly, the organization has advised against mammograms, apparently believing that they too are part of some corporate conspiracy. According to Barbara Brenner, executive director of the group, "benefit of routine mammograms for healthy premenopausal women is unproven."
This is a blatant lie that threatens women's lives. The scientific consensus is that routine mammography reduces the risk of dying of breast cancer in women 50 and older by up to 30%.
And in their crusade against corporate-funded research, what kind of breakthroughs is Breast Cancer Action targeting? Work by people like Northwestern University's Dr. Boris Pasche. By identifying women with variations of two specific genes that have been linked to an increased risk of cancer, Pasche and his colleagues are approaching a breakthrough that could successfully test for cancer risk in 30% of women. That could spare mothers needless trips to the doctor, exhausting rounds of chemotherapy and hospitalitzation.
In the perverse world of Breast Cancer Action, Dr. Pasche's research is suspect - because part of his financial support comes from the Avon Foundation. What's wrong with the Avon Foundation? Well, it seems the mere fact that it's linked to a profit-making company is cause enough for concern: "Breast cancer has become the poster child of corporate cause-related marketing campaigns, as companies try to boost their image and their profits by connecting themselves to a good cause," Breast Cancer Action complains on its Web site.
Perversely, this organization blames corporations for doing too much - and, at the very same time, not enough. As Brenner recently explained, "I understand that people want to do something, but if shopping could cure breast cancer, it would be cured by now." Brenner apparently isn't aware that over the last decade, thanks to countless researchers and millions of dollars in funding, the death rate from breast cancer has declined by 2.3% per year for all women. And it could go down much further, much faster, if research accelerates.
Breast Cancer's Action's twisted crusade would have corporations forget research funding and have women forgo potentially livesaving treatments. And what should replace research and science? A fight for a cleaner environment. In particular, the group insists there is irrefutable proof that chemicals called PCBs - pollutants that were in some manufactured goods before being banned in 1977 - cause breast cancer. There's no biological evidence to support such a link.
During Breast Cancer Awareness Month, this terrible disease is a formidable enough target for America to fight. We shouldn't also have to contend with the lies and hysteria being peddled by Breast Cancer Action.
End sick crusade against breast cancer research
By ROBERT GOLDBERG
Saturday, October 28th, 2006
Every October, as Breast Cancer Awareness Month rolls around, we wear pink ribbons and focus our attention on a terrible disease that takes the lives of some 40,000 American women every year. But this year, a group known as Breast Cancer Action has seized the stage - and, claiming to speak on behalf of breast cancer patients themselves, is making conspiratorial, offensive and irresponsible statements. They must be exposed as the fearmongers they are.
In a national media campaign that includes newspaper and TV ads, the upstart organization is advising women to "think before you pink" because - get this - they consider corporate donations to fight cancer research tainted by the profit motive. The group warns women against the breakthrough treatments corporate-funded research might yield.
And most alarmingly, the organization has advised against mammograms, apparently believing that they too are part of some corporate conspiracy. According to Barbara Brenner, executive director of the group, "benefit of routine mammograms for healthy premenopausal women is unproven."
This is a blatant lie that threatens women's lives. The scientific consensus is that routine mammography reduces the risk of dying of breast cancer in women 50 and older by up to 30%.
And in their crusade against corporate-funded research, what kind of breakthroughs is Breast Cancer Action targeting? Work by people like Northwestern University's Dr. Boris Pasche. By identifying women with variations of two specific genes that have been linked to an increased risk of cancer, Pasche and his colleagues are approaching a breakthrough that could successfully test for cancer risk in 30% of women. That could spare mothers needless trips to the doctor, exhausting rounds of chemotherapy and hospitalitzation.
In the perverse world of Breast Cancer Action, Dr. Pasche's research is suspect - because part of his financial support comes from the Avon Foundation. What's wrong with the Avon Foundation? Well, it seems the mere fact that it's linked to a profit-making company is cause enough for concern: "Breast cancer has become the poster child of corporate cause-related marketing campaigns, as companies try to boost their image and their profits by connecting themselves to a good cause," Breast Cancer Action complains on its Web site.
Perversely, this organization blames corporations for doing too much - and, at the very same time, not enough. As Brenner recently explained, "I understand that people want to do something, but if shopping could cure breast cancer, it would be cured by now." Brenner apparently isn't aware that over the last decade, thanks to countless researchers and millions of dollars in funding, the death rate from breast cancer has declined by 2.3% per year for all women. And it could go down much further, much faster, if research accelerates.
Breast Cancer's Action's twisted crusade would have corporations forget research funding and have women forgo potentially livesaving treatments. And what should replace research and science? A fight for a cleaner environment. In particular, the group insists there is irrefutable proof that chemicals called PCBs - pollutants that were in some manufactured goods before being banned in 1977 - cause breast cancer. There's no biological evidence to support such a link.
During Breast Cancer Awareness Month, this terrible disease is a formidable enough target for America to fight. We shouldn't also have to contend with the lies and hysteria being peddled by Breast Cancer Action.
Here are some of the more interesting headlines from this week's health and medical breakthrough news:
From Sciencenewsdaily.com
Elderly Men With Low Testosterone Levels More Likely To Fall
Low testosterone levels may be associated with a higher risk of falling in older men, according to a report in the October 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals....
Punchlines are welcome
And then there's this from that cutting edge healthcare system North of the border
Unique Bra Eases Women's Recovery From Heart Surgery
A national clinical trial led by a University of Calgary researcher has found that wearing a specialized compression bra significantly reduces women's breast pain following heart surgery.
So let's get this straight. HealthCanada will pay for this but not Plavix or Herceptin...
The autism aliens will not be convinced that mercury (the element, not the planet) does not cause that disease not matter how much scientific evidence is amassed and no matter how many death threats they send to scientists and public health officials...
Government rejects vaccine petition
By ANDREW BRIDGES, Associated Press Writer
A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.
Federal health officials won't put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.
"We're not accepting that answer," said Dr. Mark Geier, one of the petitioners.
Gee, what a surprise.
And speaking of not pleasing the paranoid, here's a headline that will make Steve Nissen, Curt Furberg and Ariana Huffington (who would ever think to see them in the same sentence?) miserable:
From Medical News Today
Popular ADHD Drug Safe And Effective For Pre-schoolers But Monitor Youngsters Closely For Side Effects, Researchers Caution
No heart problems guys. However, the study shows that in some kids side effects can include weight loss limits on height. It did not compare the impact of Ritalin with Strattera which is not a stimulant and does not have the same effect on appetite...
From Sciencenewsdaily.com
Elderly Men With Low Testosterone Levels More Likely To Fall
Low testosterone levels may be associated with a higher risk of falling in older men, according to a report in the October 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals....
Punchlines are welcome
And then there's this from that cutting edge healthcare system North of the border
Unique Bra Eases Women's Recovery From Heart Surgery
A national clinical trial led by a University of Calgary researcher has found that wearing a specialized compression bra significantly reduces women's breast pain following heart surgery.
So let's get this straight. HealthCanada will pay for this but not Plavix or Herceptin...
The autism aliens will not be convinced that mercury (the element, not the planet) does not cause that disease not matter how much scientific evidence is amassed and no matter how many death threats they send to scientists and public health officials...
Government rejects vaccine petition
By ANDREW BRIDGES, Associated Press Writer
A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.
Federal health officials won't put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.
"We're not accepting that answer," said Dr. Mark Geier, one of the petitioners.
Gee, what a surprise.
And speaking of not pleasing the paranoid, here's a headline that will make Steve Nissen, Curt Furberg and Ariana Huffington (who would ever think to see them in the same sentence?) miserable:
From Medical News Today
Popular ADHD Drug Safe And Effective For Pre-schoolers But Monitor Youngsters Closely For Side Effects, Researchers Caution
No heart problems guys. However, the study shows that in some kids side effects can include weight loss limits on height. It did not compare the impact of Ritalin with Strattera which is not a stimulant and does not have the same effect on appetite...
In case your copy of the People's Daily didn't arrive this morning, some important news ...
Chinese get genetic tests to determine disease risk
More than 300 Chinese have undergone genetic testing to determine their odds of developing cancers and other diseases. According to China's first and only genetic testing clinic at the No.1 hospital affiliated with Zhejiang University School of Medicine, more than 300 Chinese have had their DNA sampled at the center since it opened last October. "We look at a patient's medical history and family history, take their blood to analyze their DNA to look for genes that would possibly cause diseases," said Qi Ming, director of the center and professor at the university. Such tests help identify people more likely to get a disease and allow patients to take action to reduce their risk, he said. More than 1,000 genes have been found to relate to diseases. Breast cancer, colon cancer, abnormal heart rate, amyotrophic lateral sclerosis and other diseases can be detected by the DNA tests, Qi said. The tests cost between 75 U.S. dollars and several hundred dollars, he said.
This needs to become standard practice in the US if we are to successfully scale the Great Wall of EBM (evidence-based medicine).
Chinese get genetic tests to determine disease risk
More than 300 Chinese have undergone genetic testing to determine their odds of developing cancers and other diseases. According to China's first and only genetic testing clinic at the No.1 hospital affiliated with Zhejiang University School of Medicine, more than 300 Chinese have had their DNA sampled at the center since it opened last October. "We look at a patient's medical history and family history, take their blood to analyze their DNA to look for genes that would possibly cause diseases," said Qi Ming, director of the center and professor at the university. Such tests help identify people more likely to get a disease and allow patients to take action to reduce their risk, he said. More than 1,000 genes have been found to relate to diseases. Breast cancer, colon cancer, abnormal heart rate, amyotrophic lateral sclerosis and other diseases can be detected by the DNA tests, Qi said. The tests cost between 75 U.S. dollars and several hundred dollars, he said.
This needs to become standard practice in the US if we are to successfully scale the Great Wall of EBM (evidence-based medicine).
On the heels of a report that a state legislator in NY wants to make it illegal to drive while under the influence of Ambien, this piece of chilling news....
There is a massive increase in the number of people who have cars in developing countries where road traffic accidents are the fourth leading cause of death in adults aged 15-59.
Can't you see the connection? It's the Ambien, stupid. Where is Senator Grassley when we need him?
There is a massive increase in the number of people who have cars in developing countries where road traffic accidents are the fourth leading cause of death in adults aged 15-59.
Can't you see the connection? It's the Ambien, stupid. Where is Senator Grassley when we need him?
In the November issue of Commentary I make the point that Big Pharma needs to be seen as focusing more on promoting the public health than they do on promoting products.
Pfizer has just taken a significant step in that direction.
The world's biggest pharmaceutucal company has announced a collaboration that gives access to its library of medicinal compounds – the world’s largest – and also brings scientists from developing countries into Pfizer’s laboratories for training in drug discovery techniques.
The collaboration with The Special Program for Research and Training in Tropical Diseases of the WHO (WHO/TDR) is part of a new effort to link the research resources of a major pharmaceutical company to a global network of discovery research, and speed the search for new drugs to combat some of the world’s most deadly parasitic diseases, including malaria, leishmaniasis, African trypanosomiasis, onchocerciasis, schistosomiasis and Chagas' disease.
Under the arrangement, scientists in institutes affiliated with the WHO/TDR-sponsored Compound Evaluation Network are testing thousands of compounds from the Pfizer library. In a process called “screeningâ€, the researchers are seeking to identify “hits†– compounds that show initial activity against a range of tropical parasites.
Well done!
Pfizer has just taken a significant step in that direction.
The world's biggest pharmaceutucal company has announced a collaboration that gives access to its library of medicinal compounds – the world’s largest – and also brings scientists from developing countries into Pfizer’s laboratories for training in drug discovery techniques.
The collaboration with The Special Program for Research and Training in Tropical Diseases of the WHO (WHO/TDR) is part of a new effort to link the research resources of a major pharmaceutical company to a global network of discovery research, and speed the search for new drugs to combat some of the world’s most deadly parasitic diseases, including malaria, leishmaniasis, African trypanosomiasis, onchocerciasis, schistosomiasis and Chagas' disease.
Under the arrangement, scientists in institutes affiliated with the WHO/TDR-sponsored Compound Evaluation Network are testing thousands of compounds from the Pfizer library. In a process called “screeningâ€, the researchers are seeking to identify “hits†– compounds that show initial activity against a range of tropical parasites.
Well done!
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.
