Latest Drugwonks' Blog
Any minute now Senator Byron Dorgan is expected to propose an amendment to PDUFA IV that would allow for (drum roll please) drug importation.
Now Senator Dorgan is tough to reach, so rather than leaving endless phone messages and e-mails, we opted for an op-ed piece in his hometown paper, the Grand Forks Herald.
Here it is ...
Download file
Sorry Senator, those pesky facts keep getting in the way.
Now Senator Dorgan is tough to reach, so rather than leaving endless phone messages and e-mails, we opted for an op-ed piece in his hometown paper, the Grand Forks Herald.
Here it is ...
Download file
Sorry Senator, those pesky facts keep getting in the way.
Jamie Love went on a predictable rant about the exit of Randall Tobias from running the President's Emergency AIDS Program: Tobias is hypocrite for soliciting prostitutes (which Tobias acknowledges) and practicing unsafe sex (how does Love know?) and therefore unfit to run the program which he (again according to the all knowing JL) used to stress abstinence and condoms over HIV drugs.
http://www.huffingtonpost.com/james-love/randy-tobias-risky-sexua_b_47160.html
I heard Desmond Tutu on the radio (Howard Stern, no less www.howardstern.com ) where he told his interviewer about the the ABC's of HIV prevention: Abstain, Be Faithful, Condomise.
So according to Jamie's logic, Desmond Tutu was also getting massages from high priced escort services too.
Also according to Jamie's logic, no one who is sexually promiscuous and practices unprotected sex should be an ambassador on HIV issues. So I guess that excludes Bill Clinton and his Clinton HIV Foundation, right? Should I start in on the Hollywood types that are your co-bloggers Jamie?
http://www.huffingtonpost.com/james-love/randy-tobias-risky-sexua_b_47160.html
I heard Desmond Tutu on the radio (Howard Stern, no less www.howardstern.com ) where he told his interviewer about the the ABC's of HIV prevention: Abstain, Be Faithful, Condomise.
So according to Jamie's logic, Desmond Tutu was also getting massages from high priced escort services too.
Also according to Jamie's logic, no one who is sexually promiscuous and practices unprotected sex should be an ambassador on HIV issues. So I guess that excludes Bill Clinton and his Clinton HIV Foundation, right? Should I start in on the Hollywood types that are your co-bloggers Jamie?
"The doctor of the future will give no medicine, but will interest her or his patients in the care of the human frame, in a proper diet, and in the cause and prevention of disease"
-- Thomas A. Edison
Welcome to PiP.
For those of you drugwonks out there who aren't fans of Charles Dickens, here's the Cliffsnotes background on the literary character of the same name ...
Great Expectations is the story of Pip and his initial dreams and resulting disappointments that eventually lead to him becoming a genuinely good man. The significant changes that Pip's character goes through are very important to one of the novel's many themes. Dickens uses Pip's deterioration from an innocent boy into an arrogant gentleman and his redemption as a good-natured person to illustrate the idea that unrealistic hopes and expectations can lead to undesirable traits.
Yes, Pip as an allegory for Pharma.
Now welcome to PiP -- Personalized Information to Patients
As Congress debates the (clearly unconstitutional) idea of granting the FDA authority to ban DTC for any new drug's first two years of availability, the science of personalized medicine will ultimately make this debate meaningless.
As we attain the knowledge to prescribe the right medicine in the right dose for the right patient at the right time, patients and physicians will rely more on gene testing than product advertising. Indeed information will no longer only mean information about a medicine or a disease -- it'll mean information about your personal biochemistry -- hence Personalized Information to Patients.
In the not so distant future, ads for gene tests may very well replace and surpass those for medicines. Talk about disease awareness! Talk about early and accurate diagnosis! Talk about moving from an acute to a chronic care model!
But it needs to be more than just science talk and silly pieces of ersatz legislation. And that's where the FDA's Critical Path program comes into play.
If we want health care advertising to move beyond the current Cliffsnotes of health information -- DTC -- to the real deal -- Personalized Information to Paitents -- PiP -- we must create the regulatory tools that allow it to happen.
Otherwise it's just talk.
-- Thomas A. Edison
Welcome to PiP.
For those of you drugwonks out there who aren't fans of Charles Dickens, here's the Cliffsnotes background on the literary character of the same name ...
Great Expectations is the story of Pip and his initial dreams and resulting disappointments that eventually lead to him becoming a genuinely good man. The significant changes that Pip's character goes through are very important to one of the novel's many themes. Dickens uses Pip's deterioration from an innocent boy into an arrogant gentleman and his redemption as a good-natured person to illustrate the idea that unrealistic hopes and expectations can lead to undesirable traits.
Yes, Pip as an allegory for Pharma.
Now welcome to PiP -- Personalized Information to Patients
As Congress debates the (clearly unconstitutional) idea of granting the FDA authority to ban DTC for any new drug's first two years of availability, the science of personalized medicine will ultimately make this debate meaningless.
As we attain the knowledge to prescribe the right medicine in the right dose for the right patient at the right time, patients and physicians will rely more on gene testing than product advertising. Indeed information will no longer only mean information about a medicine or a disease -- it'll mean information about your personal biochemistry -- hence Personalized Information to Patients.
In the not so distant future, ads for gene tests may very well replace and surpass those for medicines. Talk about disease awareness! Talk about early and accurate diagnosis! Talk about moving from an acute to a chronic care model!
But it needs to be more than just science talk and silly pieces of ersatz legislation. And that's where the FDA's Critical Path program comes into play.
If we want health care advertising to move beyond the current Cliffsnotes of health information -- DTC -- to the real deal -- Personalized Information to Paitents -- PiP -- we must create the regulatory tools that allow it to happen.
Otherwise it's just talk.
Last week Andy von Eschenbach commented that "We all talk about change -- but usually change in somebody else." Keeping that in mind, have a look at today's lead editorial from the Washington Times ...
The recent food scares
Watching the never-ending hearings Democrats are now holding on the Food and Drug Administration reminds us of Al Capone's assertion that "I have built my organization on fear." Indeed, a day has not gone by that a show trial has not been held claiming that our drugs are unsafe, and, now that our food is poisoned because the agency is compromised by a cozy relationship between the industries, it is supposed to police and the regulators themselves. The four most common bacteria, including salmonella and e-coli, contribute to about 5,000 deaths each year and cost our economy nearly $7 billion annually. The recent spate of food-related problems -- ranging from spinach contamination to a peanut butter recall and now to the discovery that a poisonous additive may be in animal food imported from China -- underscores the importance of ensuring the safety of the nation's food supply.
But adding more bureaucrats, or, alternatively, threatening FDA officials with salary cuts, are not the responses our nation needs. The recent problems have a common theme: They are the product of a more global and industrialized process of food production that allows pathogens to spread and emerge more rapidly than was the case 20 years ago. Better tools for identifying and detecting outbreaks and contaminants in the food supply in real-time fashion are available but not in widespread use at this time.
The United States has a surveillance system in place for detecting emerging pathogens called Foodnet. In turn, it is supported by a series of labs called PulseNet that subtypes and electronically compares pathogens as they are discovered and detected. This network needs to be upgraded and enhanced.
Moreover, both the FDA and the Department of Agriculture should clear the path for the use of nanotechnology devices that will be able to detect toxins, pathogens and chemicals in the production and packaging of foods on the spot. Such devices could monitor the presence of such materials without on-site inspection. Also, they could be used to alert consumers to tainted products at the retail level.
Unfortunately, Congress is more interested in building up the size of government through fear-mongering rather than insuring the public safety with advances in technology. Capone would be proud.
Where's Elliot Ness when we need him?
The recent food scares
Watching the never-ending hearings Democrats are now holding on the Food and Drug Administration reminds us of Al Capone's assertion that "I have built my organization on fear." Indeed, a day has not gone by that a show trial has not been held claiming that our drugs are unsafe, and, now that our food is poisoned because the agency is compromised by a cozy relationship between the industries, it is supposed to police and the regulators themselves. The four most common bacteria, including salmonella and e-coli, contribute to about 5,000 deaths each year and cost our economy nearly $7 billion annually. The recent spate of food-related problems -- ranging from spinach contamination to a peanut butter recall and now to the discovery that a poisonous additive may be in animal food imported from China -- underscores the importance of ensuring the safety of the nation's food supply.
But adding more bureaucrats, or, alternatively, threatening FDA officials with salary cuts, are not the responses our nation needs. The recent problems have a common theme: They are the product of a more global and industrialized process of food production that allows pathogens to spread and emerge more rapidly than was the case 20 years ago. Better tools for identifying and detecting outbreaks and contaminants in the food supply in real-time fashion are available but not in widespread use at this time.
The United States has a surveillance system in place for detecting emerging pathogens called Foodnet. In turn, it is supported by a series of labs called PulseNet that subtypes and electronically compares pathogens as they are discovered and detected. This network needs to be upgraded and enhanced.
Moreover, both the FDA and the Department of Agriculture should clear the path for the use of nanotechnology devices that will be able to detect toxins, pathogens and chemicals in the production and packaging of foods on the spot. Such devices could monitor the presence of such materials without on-site inspection. Also, they could be used to alert consumers to tainted products at the retail level.
Unfortunately, Congress is more interested in building up the size of government through fear-mongering rather than insuring the public safety with advances in technology. Capone would be proud.
Where's Elliot Ness when we need him?
The pun couldn't be more perverse or the message more clear -- men in high public office need to keep it zipped. The fact that Mr. Tobias represented our nation on AIDS issues (like abstinence) makes this even more unfortunate. Who vetted this guy anyway? On a personal note, I served on a United Way of Indiaia committee with Tobias when he was at the helm of Eli Lilly. Hs good works were well known. But now he will be remembered for other, less noble deeds. Shameful.
From the Moscow Times ...
The State Duma will examine plans to stiffen penalties for manufacturers and distributors of counterfeit pharmaceuticals Friday, one of the sponsors of the proposed bill said Thursday.
"It will be the first reading of a bill to create a new statute in the legal code covering the manufacture, intent to supply, supply, storage, transportation and importation of counterfeit pharmaceuticals," said Pyotr Shelishch, a member of the Duma's Legislation Committee.
Counterfeit medicine is a serious problem on the Russian market, Shelishch said.
"It's difficult to say what the amount of counterfeit drugs is, but estimates range from fractions of a percentage up to 10 percent," he said. The country's pharmaceutical market is worth around $10.7 billion, according to estimates by industry consultant Pharmexpert
According to the new proposals, the minimum penalty would rise to 500,000 rubles ($20,000) and the maximum penalty would be a 15-year prison term, Shelishch said.
"The maximum sentence would be applicable if it led to the deaths of two or more people," he said.
The new measures come as a result of glaring shortcomings in existing legislation, lawmakers and analysts said.
"I welcome this new move, as we still do not have any law to punish those people that produce counterfeit drugs in Russia," said Nikolai Demidov, general director of Pharmexpert.
In November, pharmaceuticals firm Bryntsalov-A was handed a 40,000 ruble fine after being found guilty of offenses including the improper storage of drugs.
Manufacturers welcomed the proposed legislation but said new laws needed to be backed up by tougher action. "Any changes in legislation should be followed by relevant enforcement measures. Legislative amendments are meaningless without strong support of control activities from executive authorities," a GlaxoSmithKline Russia spokesman said.
"We would like to see examples being made where those found to knowingly trade in counterfeit medicines are prosecuted and receive meaningful penalties," the spokesman said. "We would also like to see an increase in checks on pharmacies and warehouses."
With international standards such as the good manufacturing practices code as yet not obligatory in Russia, Demidov said overall production control needed to be sharpened.
The prevalence of counterfeit medicine in the country has consistently been one of the major factors hampering Russia's entry into the World Trade Organization.
"Of course we are thinking first of all about our citizens, but if these measures help facilitate Russia's entry into the WTO, then that is also positive," Shelishch said.
The urgency of these requirements makes it likely that the legislative changes will be passed by the end of the year, Demidov said.
"I hope that this law will be adopted not later than September. I am linking this with the WTO membership bid," he said.
It's a good start, but the Russian government can still Duma. (Get it.)
The State Duma will examine plans to stiffen penalties for manufacturers and distributors of counterfeit pharmaceuticals Friday, one of the sponsors of the proposed bill said Thursday.
"It will be the first reading of a bill to create a new statute in the legal code covering the manufacture, intent to supply, supply, storage, transportation and importation of counterfeit pharmaceuticals," said Pyotr Shelishch, a member of the Duma's Legislation Committee.
Counterfeit medicine is a serious problem on the Russian market, Shelishch said.
"It's difficult to say what the amount of counterfeit drugs is, but estimates range from fractions of a percentage up to 10 percent," he said. The country's pharmaceutical market is worth around $10.7 billion, according to estimates by industry consultant Pharmexpert
According to the new proposals, the minimum penalty would rise to 500,000 rubles ($20,000) and the maximum penalty would be a 15-year prison term, Shelishch said.
"The maximum sentence would be applicable if it led to the deaths of two or more people," he said.
The new measures come as a result of glaring shortcomings in existing legislation, lawmakers and analysts said.
"I welcome this new move, as we still do not have any law to punish those people that produce counterfeit drugs in Russia," said Nikolai Demidov, general director of Pharmexpert.
In November, pharmaceuticals firm Bryntsalov-A was handed a 40,000 ruble fine after being found guilty of offenses including the improper storage of drugs.
Manufacturers welcomed the proposed legislation but said new laws needed to be backed up by tougher action. "Any changes in legislation should be followed by relevant enforcement measures. Legislative amendments are meaningless without strong support of control activities from executive authorities," a GlaxoSmithKline Russia spokesman said.
"We would like to see examples being made where those found to knowingly trade in counterfeit medicines are prosecuted and receive meaningful penalties," the spokesman said. "We would also like to see an increase in checks on pharmacies and warehouses."
With international standards such as the good manufacturing practices code as yet not obligatory in Russia, Demidov said overall production control needed to be sharpened.
The prevalence of counterfeit medicine in the country has consistently been one of the major factors hampering Russia's entry into the World Trade Organization.
"Of course we are thinking first of all about our citizens, but if these measures help facilitate Russia's entry into the WTO, then that is also positive," Shelishch said.
The urgency of these requirements makes it likely that the legislative changes will be passed by the end of the year, Demidov said.
"I hope that this law will be adopted not later than September. I am linking this with the WTO membership bid," he said.
It's a good start, but the Russian government can still Duma. (Get it.)
"We have the possibility of getting a very, very powerful predictive test that measures your risk of developing type 2 diabetes," said Dr. Kari Stefansson, president and CEO of Icelandic company deCODE genetics Inc.
Meanwhile AHIP wants the FDA to impose more costs and regulation to get approval of such predictive tests but proposes spending $8 billion a year to make one size fits all recommendations on which diabetes drugs Medicare should pay for.
Meanwhile AHIP wants the FDA to impose more costs and regulation to get approval of such predictive tests but proposes spending $8 billion a year to make one size fits all recommendations on which diabetes drugs Medicare should pay for.
Another story in the WSJ today about a "study" about conficts in medicine cooked up by people who have conflicts themselves, at least in the way they define conflicts. Blumenthal and Rothman's IMAP gets money from the liberal Soros whose drug companies aggressively marketed testosterone products off-label and works with Community Catalyst, which rakes in money suing drug companies through its Prescription Drug Access Litigation Project.
At least the story gets in one good quote from Tom Stossel who said it best ""If a physician can be influenced into prescribing certain drugs just because he had pizza with a pharmaceutical guy, then it's the fault of his training and not the drug company." Or his or herself.
In general, if I had a choice of doctors being "influenced" by pizza deliveries from drug reps or trial attorney funded front groups...guess which one I would choose?
Make that a pie with extra cheese.
http://content.nejm.org/cgi/content/full/356/17/1742
At least the story gets in one good quote from Tom Stossel who said it best ""If a physician can be influenced into prescribing certain drugs just because he had pizza with a pharmaceutical guy, then it's the fault of his training and not the drug company." Or his or herself.
In general, if I had a choice of doctors being "influenced" by pizza deliveries from drug reps or trial attorney funded front groups...guess which one I would choose?
Make that a pie with extra cheese.
http://content.nejm.org/cgi/content/full/356/17/1742
Brazil is now demanding that Merck lower the price for its HIV drug Efavirenz to what it is being sold in Thailand. (From $1.59 to 65 cents) If Merck does not agree (which it will) then Brazil's health minister will seek a compulsory license for the drug.
Again, unless companies come up with a long term strategy to deal with pricing in emerging or middle markets, NGOs will continue to use the CL route to ratchet down the price of ALL medicines.
No way to run a business.
Again, unless companies come up with a long term strategy to deal with pricing in emerging or middle markets, NGOs will continue to use the CL route to ratchet down the price of ALL medicines.
No way to run a business.
America's Health Insurance Plans that the Center for Medicare and Medicaid Services be “given explicit authority by Congress to us available data on comparative effectiveness and cost-effectiveness in determining in coverage policies. Similarly CMS should be empowered to set its reimbursement rates for new technologies more in alignment with added (for marginal) value of a new technology over established alternatives.“
AHIP's Steve Pearson claims that NICE cost effectiveness decisions have a high level of acceptance by physicians which are due in large part to the "very early and explicit attention to the quality of the data they use. NICE has earned a well-deserved reputation for methodological rigor, transparency, and an ability to learn."
http://www.cmwf.org/publications/publications_show.htm?doc_id=252181
Read Peter's post for a reality check.
AHIP is sucking up to the D's in Congress plain and simple. And it is working with the Commonwealth Fund to enact rationing of new medicines and devices (check out what AHIP wants the FDA to do on new device and diagnostic regulation!)
I thought AHIP had more sense and compassion. You can read the whole report that calls for the creation of a NICE like entity in America here:
http://www.ahip.org/content/pressrelease.aspx?docid=19476
AHIP's Steve Pearson claims that NICE cost effectiveness decisions have a high level of acceptance by physicians which are due in large part to the "very early and explicit attention to the quality of the data they use. NICE has earned a well-deserved reputation for methodological rigor, transparency, and an ability to learn."
http://www.cmwf.org/publications/publications_show.htm?doc_id=252181
Read Peter's post for a reality check.
AHIP is sucking up to the D's in Congress plain and simple. And it is working with the Commonwealth Fund to enact rationing of new medicines and devices (check out what AHIP wants the FDA to do on new device and diagnostic regulation!)
I thought AHIP had more sense and compassion. You can read the whole report that calls for the creation of a NICE like entity in America here:
http://www.ahip.org/content/pressrelease.aspx?docid=19476
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.
