Latest Drugwonks' Blog
Another dividend from the politics of fear: an empty antibiotic pipeline and an FDA that has pushed the safety bar for new drugs against bugs to unachievably high standards.
More people will die because of the absence of new drugs. The policies that have brough this about were built on false premises and false fears. mistrust has become an important source for scientific investigations themselves. Scientists nowadays build a career on technophobia within society. They are the first group who form the
scientific core of the precautionary coalition. They feed this information to consumer groups and politicians who, through the media and policies and hearings institutionalize mistrust, fear and suspicion.
The politics of fear breads both inaction and regulatory paternalism. Nothing is safe so everything must be regulated and tested. More is studied but nothing new is introduced because novelty has unknown risks which are judged more dangerous than the problem it was designed to solve.
So we are left with hardly any new drugs against emerging pathogens. That is the way the Luddites would have it. Better dead people than thriving, profitable drug companies.
http://www.nj.com/business/times/index.ssf?/base/business-3/11941492275600.xml&coll=5
More people will die because of the absence of new drugs. The policies that have brough this about were built on false premises and false fears. mistrust has become an important source for scientific investigations themselves. Scientists nowadays build a career on technophobia within society. They are the first group who form the
scientific core of the precautionary coalition. They feed this information to consumer groups and politicians who, through the media and policies and hearings institutionalize mistrust, fear and suspicion.
The politics of fear breads both inaction and regulatory paternalism. Nothing is safe so everything must be regulated and tested. More is studied but nothing new is introduced because novelty has unknown risks which are judged more dangerous than the problem it was designed to solve.
So we are left with hardly any new drugs against emerging pathogens. That is the way the Luddites would have it. Better dead people than thriving, profitable drug companies.
http://www.nj.com/business/times/index.ssf?/base/business-3/11941492275600.xml&coll=5
Like they say, everything you read in the newspaper is true except for those things you know about personally. This isn't always how urban myths begin -- but is certainly one of the most potent ways they are perpetuated.
Three of the most common "urban myths" of American health care (courtesy of folks like Michael Moore, Paul Krugman, et. al.) are that (1) the infant mortality rate in the US "proves" the total inadequacy of our system, (2) there are 47 million uninsured Americans -- proving the inequity of our system, and (3) We spend "too much" on health care -- proving the wastefulness of our system.
As the Ol Perfessor used to say, "Let's look at the numbers."
1. Infant Mortality
According to N. Gergory Mankiw, Professor of Economics at Harvard University, "The United States has lower life expectancy and higher infant mortality than Canada, which has national health insurance." This fact, according to Mankiw, is often taken as evidence for the inadequacy of the U.S. health system. But a recent study by June and Dave O'Neill, economists at Baruch College, from whom these numbers come, shows that the difference in health outcomes has more to do with broader social forces.
According to Manikow, "Americans are more likely than Canadians to die by accident or by homicide. For men in their 20s, mortality rates are more than 50 percent higher in the United States than in Canada, but the O'Neills show that accidents and homicides account for most of that gap. Maybe these differences have lessons for traffic laws and gun control, but they teach nothing about the U.S. system of health care.
Americans are also more likely to be obese, leading to heart disease and other medical problems. Among Americans, 31 percent of men and 33 percent of women have a body mass index of at least 30, the dividing line between overweight and obese, versus 17 percent of men and 19 percent of women in Canada. Research by the Harvard economists David Cutler, Ed Glaeser and Jesse Shapiro concludes that the growing obesity problem in the United States is largely attributable to its ability to supply high-calorie foods inexpensively.
Infant mortality rates also reflect broader social trends, including the prevalence of infants with low birth weight, which is correlated with teenage motherhood. Whatever its merits, a Canadian-style system of national health insurance is unlikely to change the sexual mores of American youths"
2- 47 Million Uninsured
This number from the Census Bureau is often cited as evidence that the health system is failing for many families. Yet, as Mankiw observes, "by masking tremendous heterogeneity in personal circumstances, the figure exaggerates the magnitude of the problem."
The 47 million includes about 10 million residents who are not U.S. citizens. Many are illegal immigrants. Even with national health insurance, they would probably not be covered.
The "Big Number" also includes millions of the poor who are eligible for Medicaid but have not yet applied. Per Mankiw, "they are uninsured in name only."
And about a quarter of the uninsured have been offered employer-provided insurance but declined coverage.
3- We spend "too much" on health care
In 1950, Americans spent about 5 percent of their income on health care. Today the share is about 16 percent. Mankiw believes that "many pundits take the increasing cost as evidence that the system is too expensive.But increasing expenditures could just as well be a symptom of success."
And he hits a homerun with a clear. concise, and uncomplicated explanation. "The reason Americans spend more than their grandparents did is not waste, fraud and abuse, but advances in medical technology and growth in incomes. Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap."
Consider the question posed by economists Charles Jones of the University of California and Robert Hall of Stanford: "As we grow older and richer, which is more valuable: a third car, yet another television, more clothing - or an extra year of life?"
Perhaps this should be added as a question to the next spate of Presidential debates?
Three of the most common "urban myths" of American health care (courtesy of folks like Michael Moore, Paul Krugman, et. al.) are that (1) the infant mortality rate in the US "proves" the total inadequacy of our system, (2) there are 47 million uninsured Americans -- proving the inequity of our system, and (3) We spend "too much" on health care -- proving the wastefulness of our system.
As the Ol Perfessor used to say, "Let's look at the numbers."
1. Infant Mortality
According to N. Gergory Mankiw, Professor of Economics at Harvard University, "The United States has lower life expectancy and higher infant mortality than Canada, which has national health insurance." This fact, according to Mankiw, is often taken as evidence for the inadequacy of the U.S. health system. But a recent study by June and Dave O'Neill, economists at Baruch College, from whom these numbers come, shows that the difference in health outcomes has more to do with broader social forces.
According to Manikow, "Americans are more likely than Canadians to die by accident or by homicide. For men in their 20s, mortality rates are more than 50 percent higher in the United States than in Canada, but the O'Neills show that accidents and homicides account for most of that gap. Maybe these differences have lessons for traffic laws and gun control, but they teach nothing about the U.S. system of health care.
Americans are also more likely to be obese, leading to heart disease and other medical problems. Among Americans, 31 percent of men and 33 percent of women have a body mass index of at least 30, the dividing line between overweight and obese, versus 17 percent of men and 19 percent of women in Canada. Research by the Harvard economists David Cutler, Ed Glaeser and Jesse Shapiro concludes that the growing obesity problem in the United States is largely attributable to its ability to supply high-calorie foods inexpensively.
Infant mortality rates also reflect broader social trends, including the prevalence of infants with low birth weight, which is correlated with teenage motherhood. Whatever its merits, a Canadian-style system of national health insurance is unlikely to change the sexual mores of American youths"
2- 47 Million Uninsured
This number from the Census Bureau is often cited as evidence that the health system is failing for many families. Yet, as Mankiw observes, "by masking tremendous heterogeneity in personal circumstances, the figure exaggerates the magnitude of the problem."
The 47 million includes about 10 million residents who are not U.S. citizens. Many are illegal immigrants. Even with national health insurance, they would probably not be covered.
The "Big Number" also includes millions of the poor who are eligible for Medicaid but have not yet applied. Per Mankiw, "they are uninsured in name only."
And about a quarter of the uninsured have been offered employer-provided insurance but declined coverage.
3- We spend "too much" on health care
In 1950, Americans spent about 5 percent of their income on health care. Today the share is about 16 percent. Mankiw believes that "many pundits take the increasing cost as evidence that the system is too expensive.But increasing expenditures could just as well be a symptom of success."
And he hits a homerun with a clear. concise, and uncomplicated explanation. "The reason Americans spend more than their grandparents did is not waste, fraud and abuse, but advances in medical technology and growth in incomes. Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap."
Consider the question posed by economists Charles Jones of the University of California and Robert Hall of Stanford: "As we grow older and richer, which is more valuable: a third car, yet another television, more clothing - or an extra year of life?"
Perhaps this should be added as a question to the next spate of Presidential debates?
Rahm Emanuel wants a stand alone vote on drug importation. So do many erstwhile Republicans like Grassley who have made a mini-career terrorizing the public about the risks of unsafe drugs. How do they square their claim the FDA is unable to protect public against unsafe medicines with a GAO report that the FDA can event inspect the overseas facilities that would import the medicines that Grassley et al assert the FDA is in a position to certify as safe?
Audit: FDA hampered in review of imported drugs
"By Douglas Stanglin, USA TODAY
The Food and Drug Administration can't adequately inspect foreign drug manufacturers because its database is so outmoded it doesn't even know how many foreign firms are shipping drugs to the United States, a government watchdog group and former FDA officials told Congress on Thursday. "
Grassley and Emanuel couldn't be playing politics with drug safety? Neither could AARP or Consumers Union who lead the charge against Kennedy Enzi because it claimed it was too lax and who supports drug importation. Of course not!! The common theme of course: screw drug companies no matter what the impact on patients or the public health because it scores political points.
http://www.usatoday.com/news/health/2007-11-01-fda-imports_N.htm
Audit: FDA hampered in review of imported drugs
"By Douglas Stanglin, USA TODAY
The Food and Drug Administration can't adequately inspect foreign drug manufacturers because its database is so outmoded it doesn't even know how many foreign firms are shipping drugs to the United States, a government watchdog group and former FDA officials told Congress on Thursday. "
Grassley and Emanuel couldn't be playing politics with drug safety? Neither could AARP or Consumers Union who lead the charge against Kennedy Enzi because it claimed it was too lax and who supports drug importation. Of course not!! The common theme of course: screw drug companies no matter what the impact on patients or the public health because it scores political points.
http://www.usatoday.com/news/health/2007-11-01-fda-imports_N.htm
Spending on medicines is down and the number of new drugs reaching the market is declining as well. No one wants to acknowledge the while a cautious FDA is part of the problem the overarching challenge facing industry -- and us -- is just how new all the targets current drug development targets are and how difficult it will be to personalize or tailor treatments to specific groups of patients. And the tools for doing so and improving the preventive capacity of next generation drugs will be snatched from companies if the industry's enemies get their way and blow up the Critical Path before it even gets started. The campaign of disinformation regarding the goals of the Critical Path and the science behind still shocks me. The ideological hatred borders on a psychological disturbance.
Where did Cong. Rosa DeLauro get her ban the Reagan Udall idea from?...And where did she get the idea that biomarkers are somehow a source of inferior science? this from Kaisernet...
" FDA seems to be moving "with unusual speed" to organize a private-public foundation to help support the agency, and some critics are saying the initiative might be "little more than a front for the industries it regulates," CQ Today reports. The group, known as the Reagan-Udall Foundation, was established in the FDA reauthorization legislation, which President Bush signed into law Sept. 27.
The 14-member board of the foundation must include three academics, two consumer advocates, one health care provider, four industry representatives and four "at-large" members with "experience relevant to the purpose of the foundation." While five of the nominees will be chosen by FDA, some critics are concerned the at-large seats will be filled by industry representatives (Adams, CQ Today, 10/2). FDA began taking nominations on Wednesday (Edney, CongressDaily, 10/3).
The foundation largely will be financed through private donations, including those from food, pharmaceutical and medical device companies, according to CQ Today (CQ Today, 10/2). It is meant to help fund research to modernize the agency, according to CongressDaily.
Critics are concerned that if drug makers gain too much influence on the foundation, the resulting criteria established for evaluating products could be excessively industry-friendly. Merrill Goozner, head of the Center for Science in the Public Interest's Integrity in Science Project, said, "The last thing you want is an industry-run board in which they create a science-sounding rationale before they put the FDA rubber stamp of approval on something that hasn't been proven." Diana Zuckerman, president of the National Research Center for Women & Families, said, "You have a situation where most of the money will be from (industry groups) -- they're going to control the board and therefore they're going to control the executive director, staff and the research."
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47990
Shame on Goozner and the rest for deliberately misleading Del Lauro and the media on what biomarkers do and can offer people in terms of safer drugs. I was there at Critical Path conference he blogged on when Janet Woodwock patiently explained the difference between a surrogate endpoint (cholesterol levels) and genetic markers that are predictive of disease progression or drug response. He is either dumb or manipulative. Or both. Here's what the FDA recently said in a guidance on drug-induced liver toxicity regarding biomarkers:
"As part of the Critical Path Initiative, 3 the FDA is working with industry, academia, and other experts to broaden our understanding of the biochemical and genetic bases of DILI. In June 2006, the FDA co-sponsored a scientific workshop to determine the feasibility of developing a mathematical (in-silico) model for DILI from which other predictive experimental models can be derived to characterize potential hepatotoxicity. The long-term goal is to develop a model, or models, that can help researchers identify criteria for determining when early clinical intervention (i.e., stopping the drug) is appropriate. It is also hoped that predictive bioassays and biomarkers can be identified that will help determine which patients most likely will suffer liver toxicity from specific compounds.
This urgently needed research is not a regulatory requirement, but is an important opportunity. At present, we are able only to search among patients with drug-induced injury to predict what might happen to others. Ideally, we should seek to identify individuals at increased risk before administering a drug that they cannot tolerate. The goal is to be able to identify persons who should never be exposed to a given drug because they are idiosyncratically hypersusceptible to, or unable to recover from, DILI caused by it. If tests that screen for people susceptible to severe DILI can be developed, a hepatotoxic drug could remain available to people who are not susceptible to severe DILI, instead of having to withdraw the drug from the market, allowing no one to benefit from it.
* In addition, identification of common genotypic characteristics among patients experiencing DILI in response to one or more class-related hepatotoxic agents might permit the development of in vitro or ex vivo tests or genetically altered animal strains that can be used to better predict serious hepatotoxic potential, or the lack thereof, of new drugs belonging to the same or closely related classes. "
Yeah, I guess a foundation that will develop tools designed to screen drugs for safety and effectiveness based on genetic markers and standardize that approach for evaluation is a bad thing. Even worse to have the companies themselves foot the bill.
I give DeLauro a pass for not knowing enough in this instance. (Note to the FDA: Hie thee to Rosa's office for a briefing on what's what. ) Not so Goozner and Zuckerman. Anyone can be wrong. Only idiots persist in their errors. Or miscreants.
" FDA seems to be moving "with unusual speed" to organize a private-public foundation to help support the agency, and some critics are saying the initiative might be "little more than a front for the industries it regulates," CQ Today reports. The group, known as the Reagan-Udall Foundation, was established in the FDA reauthorization legislation, which President Bush signed into law Sept. 27.
The 14-member board of the foundation must include three academics, two consumer advocates, one health care provider, four industry representatives and four "at-large" members with "experience relevant to the purpose of the foundation." While five of the nominees will be chosen by FDA, some critics are concerned the at-large seats will be filled by industry representatives (Adams, CQ Today, 10/2). FDA began taking nominations on Wednesday (Edney, CongressDaily, 10/3).
The foundation largely will be financed through private donations, including those from food, pharmaceutical and medical device companies, according to CQ Today (CQ Today, 10/2). It is meant to help fund research to modernize the agency, according to CongressDaily.
Critics are concerned that if drug makers gain too much influence on the foundation, the resulting criteria established for evaluating products could be excessively industry-friendly. Merrill Goozner, head of the Center for Science in the Public Interest's Integrity in Science Project, said, "The last thing you want is an industry-run board in which they create a science-sounding rationale before they put the FDA rubber stamp of approval on something that hasn't been proven." Diana Zuckerman, president of the National Research Center for Women & Families, said, "You have a situation where most of the money will be from (industry groups) -- they're going to control the board and therefore they're going to control the executive director, staff and the research."
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47990
Shame on Goozner and the rest for deliberately misleading Del Lauro and the media on what biomarkers do and can offer people in terms of safer drugs. I was there at Critical Path conference he blogged on when Janet Woodwock patiently explained the difference between a surrogate endpoint (cholesterol levels) and genetic markers that are predictive of disease progression or drug response. He is either dumb or manipulative. Or both. Here's what the FDA recently said in a guidance on drug-induced liver toxicity regarding biomarkers:
"As part of the Critical Path Initiative, 3 the FDA is working with industry, academia, and other experts to broaden our understanding of the biochemical and genetic bases of DILI. In June 2006, the FDA co-sponsored a scientific workshop to determine the feasibility of developing a mathematical (in-silico) model for DILI from which other predictive experimental models can be derived to characterize potential hepatotoxicity. The long-term goal is to develop a model, or models, that can help researchers identify criteria for determining when early clinical intervention (i.e., stopping the drug) is appropriate. It is also hoped that predictive bioassays and biomarkers can be identified that will help determine which patients most likely will suffer liver toxicity from specific compounds.
This urgently needed research is not a regulatory requirement, but is an important opportunity. At present, we are able only to search among patients with drug-induced injury to predict what might happen to others. Ideally, we should seek to identify individuals at increased risk before administering a drug that they cannot tolerate. The goal is to be able to identify persons who should never be exposed to a given drug because they are idiosyncratically hypersusceptible to, or unable to recover from, DILI caused by it. If tests that screen for people susceptible to severe DILI can be developed, a hepatotoxic drug could remain available to people who are not susceptible to severe DILI, instead of having to withdraw the drug from the market, allowing no one to benefit from it.
* In addition, identification of common genotypic characteristics among patients experiencing DILI in response to one or more class-related hepatotoxic agents might permit the development of in vitro or ex vivo tests or genetically altered animal strains that can be used to better predict serious hepatotoxic potential, or the lack thereof, of new drugs belonging to the same or closely related classes. "
Yeah, I guess a foundation that will develop tools designed to screen drugs for safety and effectiveness based on genetic markers and standardize that approach for evaluation is a bad thing. Even worse to have the companies themselves foot the bill.
I give DeLauro a pass for not knowing enough in this instance. (Note to the FDA: Hie thee to Rosa's office for a briefing on what's what. ) Not so Goozner and Zuckerman. Anyone can be wrong. Only idiots persist in their errors. Or miscreants.
Rosa L. DeLauro. The "L" stands fro "Luddite." Consider this press release that just crossed our desk:
Washington, DC – Congresswoman Rosa L. DeLauro (Conn. – 3), as part of an on-going effort to ensure that science – and not industry interests – informs decisions within the Food and Drug Administration, sent a letter to Dr. Andrew von Eschenbach, FDA Commissioner, expressing concern about the Reagan-Udall Foundation and seeking information about its creation.
“While the intended goals of the Reagan-Udall Foundation are worthy, given that it will be funded primarily by pharmaceutical companies, the FDA would be responsible for ensuring that the Foundation does not further increase the industry’s influence within the FDA,†DeLauro wrote. “Although the mission of the foundation is intended to support research that encourages an expedited FDA approval process, I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.â€
We have previously commented on such absurdity on October 15th ("Concerned Scientists") and again on October 17th ("Critical Wrath").
And, yes, this is same Rosa DeLauro who spoke so passionately in favor of H.R. 2693, The Popcorn Workers Lung Disease Prevention Act.
What else can be said?
Washington, DC – Congresswoman Rosa L. DeLauro (Conn. – 3), as part of an on-going effort to ensure that science – and not industry interests – informs decisions within the Food and Drug Administration, sent a letter to Dr. Andrew von Eschenbach, FDA Commissioner, expressing concern about the Reagan-Udall Foundation and seeking information about its creation.
“While the intended goals of the Reagan-Udall Foundation are worthy, given that it will be funded primarily by pharmaceutical companies, the FDA would be responsible for ensuring that the Foundation does not further increase the industry’s influence within the FDA,†DeLauro wrote. “Although the mission of the foundation is intended to support research that encourages an expedited FDA approval process, I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.â€
We have previously commented on such absurdity on October 15th ("Concerned Scientists") and again on October 17th ("Critical Wrath").
And, yes, this is same Rosa DeLauro who spoke so passionately in favor of H.R. 2693, The Popcorn Workers Lung Disease Prevention Act.
What else can be said?
If you took the industy's more strident, conflicted and ideologically motivated critics at face value (Avorn, Wolfe, Nissen, Angell, Kassirer,Relman, Goozner, Consumers Union, Families USA/Soros, etc. )...the FDA is a rubber stamp, user fees are payoffs that turned the agency into a lapdog for instant approvals of every unsafe and ineffective medicine, marketing is just a series of bribes to doctors to prescribe useless drugs when generics are available...and companies could price every new drug at higher and higher prices.
Oh wait, drug approvals are at an all time low and generic drug use is at an all time high.
If this group was right these would be the best of times because they are uncontrolled monopolies with endless power. Of course if this group was right, kids would not be dying from underuse of SSRIs and VA patients would not be dying sooner than seniors in Part D.
But everything has limits and goes through cycles. Science, competitive strength, even the intelligence of the critics. Check that. Some things never change. To paraphrase Fred Allen, every time they open their mouths they subtract from the sum of human understanding.
Oh wait, drug approvals are at an all time low and generic drug use is at an all time high.
If this group was right these would be the best of times because they are uncontrolled monopolies with endless power. Of course if this group was right, kids would not be dying from underuse of SSRIs and VA patients would not be dying sooner than seniors in Part D.
But everything has limits and goes through cycles. Science, competitive strength, even the intelligence of the critics. Check that. Some things never change. To paraphrase Fred Allen, every time they open their mouths they subtract from the sum of human understanding.
FDA Says Consumers Continue to Buy Risky Drugs Online
Self-medication a concern; FDA-approved generics may be cheaper alternative
A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.
The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.
"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription," said Randall Lutter, Ph.D., FDA's deputy commissioner for policy. "In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice."
These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city, all parcels suspected by customs and border patrol of containing pharmaceuticals were stopped for a period of 24 hours. FDA then recorded data on the contents of these parcels, before handling them in accordance with its usual procedures.
In general, a Web site can appear legitimate, but in fact be a front for an illegal operation. FDA urges consumers to beware of unregulated Internet drug sellers, because many of their products might not contain the correct ingredients and could contain toxic substances. Several drugs found in this survey require special monitoring by physicians or other health care professionals for potential adverse events and to ensure their effectiveness. These include antibiotics, antidepressants, the blood thinner warfarin, and levothyroxine (a thyroid replacement hormone).
Self-medication a concern; FDA-approved generics may be cheaper alternative
A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.
The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.
"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription," said Randall Lutter, Ph.D., FDA's deputy commissioner for policy. "In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice."
These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city, all parcels suspected by customs and border patrol of containing pharmaceuticals were stopped for a period of 24 hours. FDA then recorded data on the contents of these parcels, before handling them in accordance with its usual procedures.
In general, a Web site can appear legitimate, but in fact be a front for an illegal operation. FDA urges consumers to beware of unregulated Internet drug sellers, because many of their products might not contain the correct ingredients and could contain toxic substances. Several drugs found in this survey require special monitoring by physicians or other health care professionals for potential adverse events and to ensure their effectiveness. These include antibiotics, antidepressants, the blood thinner warfarin, and levothyroxine (a thyroid replacement hormone).
Headline in today’s edition of the Wall Street Journal reports on a new IMS report that, “Prescription-Drug Sales Growth Is Expected to Slow.â€
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB119387833538878513.html?mod=dist_smartbrief
What the headline means is that the sales volume of on-patent drugs will slow, not that the use of pharmaceutical products will decrease. Important distinction.
As the WSJ reports, “IMS forecasts that about two-thirds of prescriptions dispensed in the U.S. next year will be generics, up from 50% in 2003.â€
The article also comments on the pipeline and regulatory environment, “Drug companies, meanwhile, aren't churning out enough new medicines to keep dollar sales growing at the same pace. And regulators such as the Food and Drug Administration, burned by several drug-safety scandals, are casting a tougher eye on new products before allowing them on the market.â€
First, as to the FDA “casting a tougher eye,†the agency always casts a tough, educated, professional eye on its actions. And new legislation gives the FDA even more authority and funding to do its job better. “Better†not “Tougher†– it’s an important distinction.
As to the fact that drug companies aren’t “churning out†enough new medicines, one thought – new drugs are never “churned out.†That’s a pretty glib statement considering that, despite the increase in R&D spending, the number of new innovative products being submitted to the FDA for approval is decreasing. In fact, output of new products has been dropping since 1997. FDA is now receiving fewer applications for new drugs than in mid-1990’s. The number of new device applications is also decreasing.
And the rate of failure is increasing. Almost 50% of applications are failing in late-stage Phase 3 trials. This costs companies millions of extra dollars and is driving up the cost of successfully bringing a new drug to market. In 2003, researchers at Tufts Center for the Study of Drug Development estimated these costs to be $802 million, and some sources suggest that the total cost is closer to $1.7 billion.
As the late US Senator Everitt Dirksen once said, “A billion here and a billion there, and pretty soon you’re talking about real money.â€
The high cost of R&D is forcing many companies to make the short-term business decision to focus product-development on those molecules that have a much higher potential to recoup expenditures. Unfortunately, this trumps attempts to develop potentially risky but breakthrough products for diseases affecting smaller populations, the orphan drugs.
Consider the implications if FDA could help companies to fail faster. Using the lower end of the Tufts drug development number …
* A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.
* Shifting 5% of clinical failures from Phase 3 to Phase 1 reduces out of pocket costs by $15-$20 million
* Shifting ¼ of failures from Phase 2 to Phase 1 would reduce out of pocket costs by $12-$21 million.
Hence the urgency of the FDA’s Critical Path program.
Here’s a link to the complete WSJ story:
http://online.wsj.com/article/SB119387833538878513.html?mod=dist_smartbrief
What the headline means is that the sales volume of on-patent drugs will slow, not that the use of pharmaceutical products will decrease. Important distinction.
As the WSJ reports, “IMS forecasts that about two-thirds of prescriptions dispensed in the U.S. next year will be generics, up from 50% in 2003.â€
The article also comments on the pipeline and regulatory environment, “Drug companies, meanwhile, aren't churning out enough new medicines to keep dollar sales growing at the same pace. And regulators such as the Food and Drug Administration, burned by several drug-safety scandals, are casting a tougher eye on new products before allowing them on the market.â€
First, as to the FDA “casting a tougher eye,†the agency always casts a tough, educated, professional eye on its actions. And new legislation gives the FDA even more authority and funding to do its job better. “Better†not “Tougher†– it’s an important distinction.
As to the fact that drug companies aren’t “churning out†enough new medicines, one thought – new drugs are never “churned out.†That’s a pretty glib statement considering that, despite the increase in R&D spending, the number of new innovative products being submitted to the FDA for approval is decreasing. In fact, output of new products has been dropping since 1997. FDA is now receiving fewer applications for new drugs than in mid-1990’s. The number of new device applications is also decreasing.
And the rate of failure is increasing. Almost 50% of applications are failing in late-stage Phase 3 trials. This costs companies millions of extra dollars and is driving up the cost of successfully bringing a new drug to market. In 2003, researchers at Tufts Center for the Study of Drug Development estimated these costs to be $802 million, and some sources suggest that the total cost is closer to $1.7 billion.
As the late US Senator Everitt Dirksen once said, “A billion here and a billion there, and pretty soon you’re talking about real money.â€
The high cost of R&D is forcing many companies to make the short-term business decision to focus product-development on those molecules that have a much higher potential to recoup expenditures. Unfortunately, this trumps attempts to develop potentially risky but breakthrough products for diseases affecting smaller populations, the orphan drugs.
Consider the implications if FDA could help companies to fail faster. Using the lower end of the Tufts drug development number …
* A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.
* Shifting 5% of clinical failures from Phase 3 to Phase 1 reduces out of pocket costs by $15-$20 million
* Shifting ¼ of failures from Phase 2 to Phase 1 would reduce out of pocket costs by $12-$21 million.
Hence the urgency of the FDA’s Critical Path program.
Without fanfare or media coverage the European Medicines Agency reaffirmed that use of epo shoudl be handled by doctors -- not by bureaucrats -- and that there should be no hard and fast hemoglobin level imposed from above, rather a flexible level achieved as befits the needs and quality of life of individual patients.
That puts Europe light years ahead of our CMS that has deemed it cost effective and safe to toss tons of seniors into the dark ages of blood transfusions. I wonder what Pharmalot and others who had predicted a tightening of EMEA guidelines will say? Ditto the fact that the EMEA also took a mature approach to Avandia. But that is a post for another day.
For now, it is clear that CMS over-reached using the wrong data to achieve an over-restrictive decision inconsistent with the emergence of patient-centric medicine. EMEA is moving in that direction. So is FDA. Both have Critical Path programs designed to integrate the tools and knowledge to promote patient variation into the development and use of new drugs. Why not a Critical Path for CMS to achieve the same goal in developing insights into the value of new treatments?
So here's my proposal for a Critical Path for Comparative Effectiveness for CMS. Comments and thoughts welcome.
CMS should initiate a Critical Path for comparative effectiveness much as the FDA developed a Critical Path for drug approval and development. “The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured.†CMS needs to initiate in a manner that is as transparent and as collaborative as that undertaken by the FDA to promote a national effort to modernize the science information the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA critical path are genetic variations and biomedical informatics that predict and inform individual responses to treatment, CMS needs to establish a process to incorporate knowledge and tools that personalize evidence of response in its decisions.
It should to the extent possible use coverage to evidence development, research grants and partnerships with industry, the FDA, NIH, the new Reagan-Udall Critical path institute to “ harness the potential of bioinformation used to evaluate and predict safety, effectiveness, and value of treatments for each patients.
Rather than focusing on coverage decisions, CMS should focus on identifying opportunities and developing tools to improve clinical decision-making based on new science. The FDA has developed a Critical Path opportunities list in cooperation with many interested parties that provides 76 concrete examples of how new scientific discoveries—in fields such as genomics and proteomics, imaging, and bioinformatics—could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products. CMS should begin the process of developing a similar list of ways new discoveries and tools such as electronic patient records could be used to improve the predictive and prospective nature of medicine.
As a first step, CMS could use the reopening of the ESA coverage decision as example for how to achieve a more targeted and patient-centered use of ESAs in chemotherapy. An opportunities list could be generated around this particular issue with continued coverage conditioned upon participation in Critical Path activities.
That puts Europe light years ahead of our CMS that has deemed it cost effective and safe to toss tons of seniors into the dark ages of blood transfusions. I wonder what Pharmalot and others who had predicted a tightening of EMEA guidelines will say? Ditto the fact that the EMEA also took a mature approach to Avandia. But that is a post for another day.
For now, it is clear that CMS over-reached using the wrong data to achieve an over-restrictive decision inconsistent with the emergence of patient-centric medicine. EMEA is moving in that direction. So is FDA. Both have Critical Path programs designed to integrate the tools and knowledge to promote patient variation into the development and use of new drugs. Why not a Critical Path for CMS to achieve the same goal in developing insights into the value of new treatments?
So here's my proposal for a Critical Path for Comparative Effectiveness for CMS. Comments and thoughts welcome.
CMS should initiate a Critical Path for comparative effectiveness much as the FDA developed a Critical Path for drug approval and development. “The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured.†CMS needs to initiate in a manner that is as transparent and as collaborative as that undertaken by the FDA to promote a national effort to modernize the science information the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA critical path are genetic variations and biomedical informatics that predict and inform individual responses to treatment, CMS needs to establish a process to incorporate knowledge and tools that personalize evidence of response in its decisions.
It should to the extent possible use coverage to evidence development, research grants and partnerships with industry, the FDA, NIH, the new Reagan-Udall Critical path institute to “ harness the potential of bioinformation used to evaluate and predict safety, effectiveness, and value of treatments for each patients.
Rather than focusing on coverage decisions, CMS should focus on identifying opportunities and developing tools to improve clinical decision-making based on new science. The FDA has developed a Critical Path opportunities list in cooperation with many interested parties that provides 76 concrete examples of how new scientific discoveries—in fields such as genomics and proteomics, imaging, and bioinformatics—could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products. CMS should begin the process of developing a similar list of ways new discoveries and tools such as electronic patient records could be used to improve the predictive and prospective nature of medicine.
As a first step, CMS could use the reopening of the ESA coverage decision as example for how to achieve a more targeted and patient-centered use of ESAs in chemotherapy. An opportunities list could be generated around this particular issue with continued coverage conditioned upon participation in Critical Path activities.
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.
