Latest Drugwonks' Blog
Which readily available sedative is associated with the most traffic accidents according to the National Transportation Safety Board:
A. Ambien
B. Benadryl
C. Lunesta
D. Sanjaya Malakar
Anyone who answered D has been watching way too much American Idol. The correct answer is B.
Prescription and OTC medicines that can cause drowsiness include analgesics (pain relievers), antianxiety medication, allergy medicines (antihistamines), blood-sugar medicines, antidepressants, tranquilizers, blood pressure medicines, motion sickness medicines, ulcer medicines, antibiotics, antiseizure medicines, cough syrups and decongestants. According to the National Transportation Safety Board (NTSB), the three most commonly used OTC medications that cause drowsiness are pain relievers, antihistamines and antidepressants.
According to a report published by Vanderbilt University, taking sedating antidepressants even 10 hours before driving is equivalent to driving drunk.
A. Ambien
B. Benadryl
C. Lunesta
D. Sanjaya Malakar
Anyone who answered D has been watching way too much American Idol. The correct answer is B.
Prescription and OTC medicines that can cause drowsiness include analgesics (pain relievers), antianxiety medication, allergy medicines (antihistamines), blood-sugar medicines, antidepressants, tranquilizers, blood pressure medicines, motion sickness medicines, ulcer medicines, antibiotics, antiseizure medicines, cough syrups and decongestants. According to the National Transportation Safety Board (NTSB), the three most commonly used OTC medications that cause drowsiness are pain relievers, antihistamines and antidepressants.
According to a report published by Vanderbilt University, taking sedating antidepressants even 10 hours before driving is equivalent to driving drunk.
Some brickbats and bouquets from the March 14 HELP hearing, “Drug User Fees: Enhancing Patient Access and Drug Safety†...
Bouquets to Senator (Chairman) Kennedy who said the user fee system “demonstrates the failure by Congress to give FDA the funds it needs to do the job that the American public counts on it to do.†And that Congress should “correct this failing, so that FDA does not have to rely excessively on user fees for its basic budget.â€
Brickbats to Senator Mikulski who believes there is a “perception that FDA is politicized†because of events like Dr. Susan Wood’s resignation as the Office’s Director, and recent reports that Dr. von Eschenbach intends to cut the Office’s budget by 25%.
And bouquets to Commissioner von E for “clarifying†that reports about a proposed 25% cut in the Office’s budget are “misperceptions.†He stated that he has “no intention to reduce FDA’s commitment to women’s health.â€
Bouquets (along with the Dan Troy Prize for First Amendment Sensitivity) to Senator Richard Burr who pointed out that S. 484’s two-year ban on DTC for certain products “will probably not meet a constitutionality test.â€
And brickbats to Senator Sherrod Brown who shrugged off the relevance of the US Constitution by commenting that he’s not sure if there are constitutional issues related to limiting DTC advertising.
(Note to Drugwonks readers – we are sure.)
We award our final bouquet to Mark McClellan who pointed out to the committee that that FDA “needs the manpower, technical skills, and technical support to carry out their increasingly complex oversight requirements effectively.†And that “we should aim for nothing less than world class data for evaluating drugs through their lifecycle.â€
Amen.
FYI -- Complete witness testimony is available at:
http://help.senate.gov/Hearings/2007_03_14/2007_03_14.html
Enjoy.
Bouquets to Senator (Chairman) Kennedy who said the user fee system “demonstrates the failure by Congress to give FDA the funds it needs to do the job that the American public counts on it to do.†And that Congress should “correct this failing, so that FDA does not have to rely excessively on user fees for its basic budget.â€
Brickbats to Senator Mikulski who believes there is a “perception that FDA is politicized†because of events like Dr. Susan Wood’s resignation as the Office’s Director, and recent reports that Dr. von Eschenbach intends to cut the Office’s budget by 25%.
And bouquets to Commissioner von E for “clarifying†that reports about a proposed 25% cut in the Office’s budget are “misperceptions.†He stated that he has “no intention to reduce FDA’s commitment to women’s health.â€
Bouquets (along with the Dan Troy Prize for First Amendment Sensitivity) to Senator Richard Burr who pointed out that S. 484’s two-year ban on DTC for certain products “will probably not meet a constitutionality test.â€
And brickbats to Senator Sherrod Brown who shrugged off the relevance of the US Constitution by commenting that he’s not sure if there are constitutional issues related to limiting DTC advertising.
(Note to Drugwonks readers – we are sure.)
We award our final bouquet to Mark McClellan who pointed out to the committee that that FDA “needs the manpower, technical skills, and technical support to carry out their increasingly complex oversight requirements effectively.†And that “we should aim for nothing less than world class data for evaluating drugs through their lifecycle.â€
Amen.
FYI -- Complete witness testimony is available at:
http://help.senate.gov/Hearings/2007_03_14/2007_03_14.html
Enjoy.
Meredith Salisbury, is the editor of Genome Technology, the one 'trade' publication everyone must read to learn about the tools and toolmakers that will shape medicine in the 21st century. In the current issue of her publication she has put together the Myths and Misconceptions the people hold about patenting ideas in academia. Most of them comprise the intellectual framework of those that want to drive companies and private investment out of medicine altogether. They are Luddites. As Ms. Salisbury points out concisely and elegantly:
"...More academics follow through on patenting because it can be the fastest and most effective way of getting a research breakthrough to the public. Companies that have to commercialize new technology or other types of discovers want some assurance that they're protected while they're making it ready for market and the first thing they look for is a solid IT position."
For the entire article and to sign up to become a subscriber (you should) go to genome-technology.com
"...More academics follow through on patenting because it can be the fastest and most effective way of getting a research breakthrough to the public. Companies that have to commercialize new technology or other types of discovers want some assurance that they're protected while they're making it ready for market and the first thing they look for is a solid IT position."
For the entire article and to sign up to become a subscriber (you should) go to genome-technology.com
From Marketwatch.com
http://www.marketwatch.com/news/story/lilly-ceo-zyprexa-2007-seen/story.aspx?guid=%7BF408D59C-9B62-4814-872E-6D94F8186E15%7D
Eli Lilly & Co. Chief Executive Officer Sidney Taurel said Wednesday that because of lingering safety concerns, sales of its blockbuster psychiatric drug Zyprexa in 2007 will largely be flat with 2006 sales.
In an interview with reporters, Taurel said that while Lilly
doesn't anticipate a notable decline in Zyprexa sales, it also doesn't see any substantial growth on the horizon, at least for this year.
"The positioning of the drug is for our sales reps to help physicians identify those patients for whom the efficacy of the drug offsets the potential concern for side effects, and those are, in particular, the urgent patients," said Taurel.
Taurel made his remarks during a meeting of the Boston College Chief Executive's Club in Boston.
Used to treat schizophrenia and bi-polar disorder, Zyprexa has been linked with substantial weight gain in some patients and suspected of triggering diabetes in others.
"They (patients) can use it for awhile, and if they find out there's too much weight gain, they can switch to something else," Taurel continued. "I think the product has found its positioning that way and that's why sales have stabilized."
Except people don't switch to something else. They just stop taking drugs. Period. Or, as with the case when the media fed the SSRI scaremongering, they don't take drugs at all. As with depression, untreated, schizophrenia and manic depression can lead to violence, self-mutilation, substance abuse and suicide.
I am afraid that the slowing sales is a signal of tragedy to come. Lilly has been warning of weight gain and diabetes for years. Coming up with something other than trial and error before starting with meds is what we need to shoot for and is best for all. But others have fanned the flames of fear.
http://www.marketwatch.com/news/story/lilly-ceo-zyprexa-2007-seen/story.aspx?guid=%7BF408D59C-9B62-4814-872E-6D94F8186E15%7D
Eli Lilly & Co. Chief Executive Officer Sidney Taurel said Wednesday that because of lingering safety concerns, sales of its blockbuster psychiatric drug Zyprexa in 2007 will largely be flat with 2006 sales.
In an interview with reporters, Taurel said that while Lilly
doesn't anticipate a notable decline in Zyprexa sales, it also doesn't see any substantial growth on the horizon, at least for this year.
"The positioning of the drug is for our sales reps to help physicians identify those patients for whom the efficacy of the drug offsets the potential concern for side effects, and those are, in particular, the urgent patients," said Taurel.
Taurel made his remarks during a meeting of the Boston College Chief Executive's Club in Boston.
Used to treat schizophrenia and bi-polar disorder, Zyprexa has been linked with substantial weight gain in some patients and suspected of triggering diabetes in others.
"They (patients) can use it for awhile, and if they find out there's too much weight gain, they can switch to something else," Taurel continued. "I think the product has found its positioning that way and that's why sales have stabilized."
Except people don't switch to something else. They just stop taking drugs. Period. Or, as with the case when the media fed the SSRI scaremongering, they don't take drugs at all. As with depression, untreated, schizophrenia and manic depression can lead to violence, self-mutilation, substance abuse and suicide.
I am afraid that the slowing sales is a signal of tragedy to come. Lilly has been warning of weight gain and diabetes for years. Coming up with something other than trial and error before starting with meds is what we need to shoot for and is best for all. But others have fanned the flames of fear.
Here's something that should be required reading for all those covering the biotech industry at the WSJ. Think of it as diversity training..
The Business & Media Institute’s new in-depth study Prescription for Bias,†which documents unbalanced media coverage of the pharmaceutical industry. Released today, the report quantifies the bias against drug companies based on analysis of 132 stories on prescription or over-the-counter drugs from the ABC, CBS and NBC evening newscasts between January 1 and Sept. 30, 2006.
Among the study’s key findings:
· Industry Ignored – 80% of stories excluded the viewpoint of the pharmaceutical industry
· Cost to Consumer – Media overemphasized consumer drug costs as opposed to drug development costs at a radio of 11:1
· Companies Unnoticed – Only 22% of the stories even named the company responsible for developing life saving cures
· What Development Costs? – A mere 2% of the stories addressed the cost to companies for researching and developing drugs
The report also includes recommendations to improve network coverage.
The full report can be found at:
http://www.businessandmedia.org/specialreports/2007/PrescriptionForBias/PrescriptionForBias_execsum.asp
Oddly enough, a story that aired on all networks last night was consistent with many of the reports findings. When reporting on the new breakthrough drug Tykerb, the media failed to give due credit to GlaxoSmithKline or report the development costs. You can read about it here:
http://www.businessandmedia.org/articles/2007/20070314165615.aspx
The Business & Media Institute’s new in-depth study Prescription for Bias,†which documents unbalanced media coverage of the pharmaceutical industry. Released today, the report quantifies the bias against drug companies based on analysis of 132 stories on prescription or over-the-counter drugs from the ABC, CBS and NBC evening newscasts between January 1 and Sept. 30, 2006.
Among the study’s key findings:
· Industry Ignored – 80% of stories excluded the viewpoint of the pharmaceutical industry
· Cost to Consumer – Media overemphasized consumer drug costs as opposed to drug development costs at a radio of 11:1
· Companies Unnoticed – Only 22% of the stories even named the company responsible for developing life saving cures
· What Development Costs? – A mere 2% of the stories addressed the cost to companies for researching and developing drugs
The report also includes recommendations to improve network coverage.
The full report can be found at:
http://www.businessandmedia.org/specialreports/2007/PrescriptionForBias/PrescriptionForBias_execsum.asp
Oddly enough, a story that aired on all networks last night was consistent with many of the reports findings. When reporting on the new breakthrough drug Tykerb, the media failed to give due credit to GlaxoSmithKline or report the development costs. You can read about it here:
http://www.businessandmedia.org/articles/2007/20070314165615.aspx
I have been going back and forth in my own mind about my initial reaction to Abbott's decision to not sell new medicines in Thailand pending a shift in the policy of patent theft on the part of the junta-run government there. At first I thought, this will only make the perception worse. But then it struck me it is not as if compulsory licensing has actually made any medicines any more available in any country. The only people who benefit from compulsory licensing appear to be the small circle of generic companies, government bureaucrats and media-thirsty NGOs who use the tactic to use drug companies to divert attention away from the real problems causing disease. Just as free food does not solve the problem of world hunger and free measles shots has not eradicated measles (500,000 African kids a year still die from measles) the short sick history of CL has proven that low cost copycats of drugs do not improve health in third world countries. Just the opposite, it usually makes things worse, encouraging piracy, profiteering and counterfeiting. I have said it before and I will say it again, the NGOs who support CL are more interested in killing drug companies than in saving lives.
Good for Abbott and Novartis for refusing to sell new medicines. Other companies should follow suit... and set up their own distribution programs as necessary.
Good for Abbott and Novartis for refusing to sell new medicines. Other companies should follow suit... and set up their own distribution programs as necessary.
Sid Taurel, Lilly CEO has an editorial in the Boston Herald about the mission of drug companies, of all things. More CEOs should talk about the science they are investing in and do it often.
Taurel writes:
"We are now beginning to understand biology as a set of information processes, and we’re developing realistic models of how disease and aging progress. And, we are developing the tools to reprogram them.
I believe that this represents the most exciting and important story in any technology field in this new century.
It might take decades for biologists to map all of this territory . . . and fully solve these new puzzles. But the good news is that patients will not have to wait decades to see the medical benefits of this massive effort. "
Unless military juntas, backed by certain members of Congress, make a hash of IP globally.
http://news.bostonherald.com/editorial/view.bg?articleid=187903&format=&page=1
Taurel writes:
"We are now beginning to understand biology as a set of information processes, and we’re developing realistic models of how disease and aging progress. And, we are developing the tools to reprogram them.
I believe that this represents the most exciting and important story in any technology field in this new century.
It might take decades for biologists to map all of this territory . . . and fully solve these new puzzles. But the good news is that patients will not have to wait decades to see the medical benefits of this massive effort. "
Unless military juntas, backed by certain members of Congress, make a hash of IP globally.
http://news.bostonherald.com/editorial/view.bg?articleid=187903&format=&page=1
This from fark.com...
FDA and drug makers claim that patients who eat and drive while under the influence of sleeping pills are actually asleep, rather than awake, intoxicated, and making bad decisions.
FDA and drug makers claim that patients who eat and drive while under the influence of sleeping pills are actually asleep, rather than awake, intoxicated, and making bad decisions.
What's the cost of playing politics with health care? Well, in this case, it seems to be $10 billion -- charged to the American tax payer by Representatives Waxman, Barton, and McCrery.
Lawmaker Inquiry May Bump Medicare Costs
By KEVIN FREKING, Associated Press Writer
WASHINGTON -- A lawmaker's inquiry could slightly increase the cost of the Medicare drug benefit if its results are publicized, congressional auditors said Tuesday.
Rep. Henry Waxman, D-Calif., has asked several insurers sponsoring Medicare drug plans to submit information about price concessions they wring from drug manufacturers. That pricing information is given to the Centers for Medicare and Medicaid Services, but cannot be disclosed.
Waxman's request has pharmaceutical companies worried, though he has not said what he would do with the information once he gets it.
The Congressional Budget Office estimates that disclosing the discounts means the cost of the drug benefit would likely increase by less than $10 billion over a 10-year period, and possibly much less.
The program is expected to cost about $45 billion this year alone.
Under the drug program, manufacturers typically give insurers a discount if they agree to cover a particular drug for their customers. The manufacturers would be less likely to offer the large rebates if they had to provide it to other types of insurance plans in the private sector, which would increase costs for the government and for enrollees, auditors said.
The publication of the prices also could encourage "tacit collusion" among the manufacturers of comparable medicines, they said. Such collusion occurs if drug makers offer similar discounts rather than trying to outdo each other in their pricing.
The CBO had originally projected in 2003 that disclosing discounts would increase the cost of the program by $40 billion over 10 years. The CBO lowered its estimate, in part, because Medicare plans are not getting substantially different discounts than what commercial plans get. The CBO had originally projected that Medicare plans would get substantially larger discounts, but the difference has been narrower than expected.
Two Republicans, Reps. Joe Barton of Texas and Jim McCrery of Louisiana, requested the CBO analysis.
Lawmaker Inquiry May Bump Medicare Costs
By KEVIN FREKING, Associated Press Writer
WASHINGTON -- A lawmaker's inquiry could slightly increase the cost of the Medicare drug benefit if its results are publicized, congressional auditors said Tuesday.
Rep. Henry Waxman, D-Calif., has asked several insurers sponsoring Medicare drug plans to submit information about price concessions they wring from drug manufacturers. That pricing information is given to the Centers for Medicare and Medicaid Services, but cannot be disclosed.
Waxman's request has pharmaceutical companies worried, though he has not said what he would do with the information once he gets it.
The Congressional Budget Office estimates that disclosing the discounts means the cost of the drug benefit would likely increase by less than $10 billion over a 10-year period, and possibly much less.
The program is expected to cost about $45 billion this year alone.
Under the drug program, manufacturers typically give insurers a discount if they agree to cover a particular drug for their customers. The manufacturers would be less likely to offer the large rebates if they had to provide it to other types of insurance plans in the private sector, which would increase costs for the government and for enrollees, auditors said.
The publication of the prices also could encourage "tacit collusion" among the manufacturers of comparable medicines, they said. Such collusion occurs if drug makers offer similar discounts rather than trying to outdo each other in their pricing.
The CBO had originally projected in 2003 that disclosing discounts would increase the cost of the program by $40 billion over 10 years. The CBO lowered its estimate, in part, because Medicare plans are not getting substantially different discounts than what commercial plans get. The CBO had originally projected that Medicare plans would get substantially larger discounts, but the difference has been narrower than expected.
Two Republicans, Reps. Joe Barton of Texas and Jim McCrery of Louisiana, requested the CBO analysis.
And what did the military junta expect, a big wet kiss?
Abbott Won't Launch New Drugs
In Thailand After Patent Revocation
By NICHOLAS ZAMISKA
Abbott Laboratories has decided against launching any new medicines in Thailand in response to the military-installed government's decision to revoke the company's patent for its blockbuster AIDS drug, according to people familiar with the matter.
The U.S. drug maker has also withdrawn its current drug applications from the government review process, these people said, adding that Abbott has no plans to stop selling drugs that are currently on the market.
Abbott's move, which could leave patients in Thailand with fewer options for treatment of certain conditions, raises the stakes in a battle between multinational pharmaceutical companies and the Thai government that took power following a military coup last year.
In January, the government said it would suspend patent protections for two drugs to make them more widely available to patients who need them. These included the HIV treatment Kaletra, made by Abbott, of Abbott Park, Ill., and Plavix, a blood-thinning drug originally developed by Sanofi-Aventis SA of Paris and co-marketed in several countries by New York-based Bristol-Myers Squibb Co.
In certain situations, including national emergencies, World Trade Organization rules allow a government to unilaterally make or sell patented drugs without the permission of the drug companies. However, pharmaceutical companies have criticized Thailand for stretching the scope of those rules beyond widely accepted boundaries.
Abbott has withdrawn its application for seven medicines, according to a person familiar with the matter, including a new formulation of Kaletra, the AIDS treatment. Abbott notified the Thai government a few weeks ago, after talks between the two sides broke down, the person familiar with the matter said.
A decision that may keep critical, life-saving drugs away of patients who need them could prove controversial for Abbott. "It's not good for anyone, even the American company because they will lose the market," says Thawat Suntrajarn, director general of the Ministry of Health's department of disease control, who says that he was unaware of Abbott's decision.
Abbott Won't Launch New Drugs
In Thailand After Patent Revocation
By NICHOLAS ZAMISKA
Abbott Laboratories has decided against launching any new medicines in Thailand in response to the military-installed government's decision to revoke the company's patent for its blockbuster AIDS drug, according to people familiar with the matter.
The U.S. drug maker has also withdrawn its current drug applications from the government review process, these people said, adding that Abbott has no plans to stop selling drugs that are currently on the market.
Abbott's move, which could leave patients in Thailand with fewer options for treatment of certain conditions, raises the stakes in a battle between multinational pharmaceutical companies and the Thai government that took power following a military coup last year.
In January, the government said it would suspend patent protections for two drugs to make them more widely available to patients who need them. These included the HIV treatment Kaletra, made by Abbott, of Abbott Park, Ill., and Plavix, a blood-thinning drug originally developed by Sanofi-Aventis SA of Paris and co-marketed in several countries by New York-based Bristol-Myers Squibb Co.
In certain situations, including national emergencies, World Trade Organization rules allow a government to unilaterally make or sell patented drugs without the permission of the drug companies. However, pharmaceutical companies have criticized Thailand for stretching the scope of those rules beyond widely accepted boundaries.
Abbott has withdrawn its application for seven medicines, according to a person familiar with the matter, including a new formulation of Kaletra, the AIDS treatment. Abbott notified the Thai government a few weeks ago, after talks between the two sides broke down, the person familiar with the matter said.
A decision that may keep critical, life-saving drugs away of patients who need them could prove controversial for Abbott. "It's not good for anyone, even the American company because they will lose the market," says Thawat Suntrajarn, director general of the Ministry of Health's department of disease control, who says that he was unaware of Abbott's decision.
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.
