Latest Drugwonks' Blog
Editorial from today's edition of the New York Times:
Editorial
Fighting Drug Fakes
Published: December 12, 2006
Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.
In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.
In Panama, dozens of people died after taking counterfeit drugs made with an industrial solvent. Often counterfeiters put in real ingredients for their smell or taste, but heavily diluted. This has sped the emergence of resistant strains of infections, and is probably a big reason some malaria drugs and antibiotics have lost their power.
Drug counterfeiting can be fought. Five years ago, the majority of Nigeria’s drugs were fakes, and the country was a major source of counterfeits abroad. When the Nigerian government donated 88,000 doses of meningitis vaccine to Niger during an epidemic in 1995, the vaccine turned out to be a fake — causing more than 2,500 children to die.
Now the possibility that a drug is fake in Nigeria has dropped to 17 percent, according to the World Health Organization. The country’s drug control agency is informing people through radio and TV jingles about fake medicines. It has also fired corrupt officials, hired a fleet of inspectors to drop in on pharmacies, banned imports from some 30 companies, and begun prosecuting counterfeiters.
One of the problems Nigeria still faces is that the penalty for counterfeiting medicine is as little as a $70 fine — a small price to pay for a crime that can reap a fortune. All over the developing world, governments treat falsifying medicines as a mere copyright infringement, rather than potential murder.
The W.H.O. has recently set up a task force that brings together many groups that work on counterfeit drugs. It is a start. Multinational drug companies — which have been reluctant to report fakes lest they erode consumer confidence in all drugs — need to do more. An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.
Wonder if Senator Vitter will put a "hold" on his subscription to the Gray Lady?
All the news that's fit to print. Amen.
Editorial
Fighting Drug Fakes
Published: December 12, 2006
Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.
In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.
In Panama, dozens of people died after taking counterfeit drugs made with an industrial solvent. Often counterfeiters put in real ingredients for their smell or taste, but heavily diluted. This has sped the emergence of resistant strains of infections, and is probably a big reason some malaria drugs and antibiotics have lost their power.
Drug counterfeiting can be fought. Five years ago, the majority of Nigeria’s drugs were fakes, and the country was a major source of counterfeits abroad. When the Nigerian government donated 88,000 doses of meningitis vaccine to Niger during an epidemic in 1995, the vaccine turned out to be a fake — causing more than 2,500 children to die.
Now the possibility that a drug is fake in Nigeria has dropped to 17 percent, according to the World Health Organization. The country’s drug control agency is informing people through radio and TV jingles about fake medicines. It has also fired corrupt officials, hired a fleet of inspectors to drop in on pharmacies, banned imports from some 30 companies, and begun prosecuting counterfeiters.
One of the problems Nigeria still faces is that the penalty for counterfeiting medicine is as little as a $70 fine — a small price to pay for a crime that can reap a fortune. All over the developing world, governments treat falsifying medicines as a mere copyright infringement, rather than potential murder.
The W.H.O. has recently set up a task force that brings together many groups that work on counterfeit drugs. It is a start. Multinational drug companies — which have been reluctant to report fakes lest they erode consumer confidence in all drugs — need to do more. An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.
Wonder if Senator Vitter will put a "hold" on his subscription to the Gray Lady?
All the news that's fit to print. Amen.
As Jennifer Corbett Doore of Dow Jones reports, "The Food and Drug Administration proposed new regulations Monday that the agency hopes will provide broader access to experimental drugs for seriously ill people who have exhausted all other commercially available treatments."
""This proposed reform is carefully designed to balance several objectives," said FDA Commissioner Dr. Andrew C. von Eschenbach. "One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."
Janet Woodcock, the FDA's deputy commissioner for operations, explained that large patient groups with cardiovascular diseases, cancer and HIV have long been able to access drugs that are currently being developed and are in clinical trials. However, outside of clinical trials, FDA regulations have been confusing and potentially a barrier to small groups and individual
patients who want to receive access to experimental treatments. The new regulations will explain how patients can receive access to such drugs, even though the patients don't fit the exact criteria for participating in the trial.
"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Woodcock said.
The proposed rules are open for public comment for 90 days.
Here's the link:
http://www.fda.gov/cder/regulatory/applications/IND_PR.htm
We will certainly be commenting.
""This proposed reform is carefully designed to balance several objectives," said FDA Commissioner Dr. Andrew C. von Eschenbach. "One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."
Janet Woodcock, the FDA's deputy commissioner for operations, explained that large patient groups with cardiovascular diseases, cancer and HIV have long been able to access drugs that are currently being developed and are in clinical trials. However, outside of clinical trials, FDA regulations have been confusing and potentially a barrier to small groups and individual
patients who want to receive access to experimental treatments. The new regulations will explain how patients can receive access to such drugs, even though the patients don't fit the exact criteria for participating in the trial.
"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Woodcock said.
The proposed rules are open for public comment for 90 days.
Here's the link:
http://www.fda.gov/cder/regulatory/applications/IND_PR.htm
We will certainly be commenting.
The FDA has been pursuing the Critical Path Initiatve and developing a scientific foundation for personalized medicine with little money and lots of effort for nearly three years...as today's FDA Week notes:
"Deputy Commissioner for Operations Janet Woodcock said Monday FDA should not concern itself with determining which drug works better for a greater portion of the population. Instead, FDA needs to facilitate development of biomarkers that can tell physicians who will respond best to which drug. '
So you would think that the pols would pay attention to growing scientific evidence and support this trend and the Critical Path withh funding to promote the public health instead of underpowered one size fits all comparative effectiveness trials pushed by Tom Cruise Health Policy Scholar Marcia Angell
No such luck.
According to FDA Week...
"Rachel Sher, Waxman's health counsel, said Waxman believes federal funding should be allotted for comparative effectiveness studies, keeping in mind any studies by industry would be biased. "
Right and ALLHAT and CATIE were models of objectivity and have told us so much. Five years and $100s of millions of dollars later. Say goodbye to all new medicines.
Henry Waxman and Tom Cruise...perfect together.
"Deputy Commissioner for Operations Janet Woodcock said Monday FDA should not concern itself with determining which drug works better for a greater portion of the population. Instead, FDA needs to facilitate development of biomarkers that can tell physicians who will respond best to which drug. '
So you would think that the pols would pay attention to growing scientific evidence and support this trend and the Critical Path withh funding to promote the public health instead of underpowered one size fits all comparative effectiveness trials pushed by Tom Cruise Health Policy Scholar Marcia Angell
No such luck.
According to FDA Week...
"Rachel Sher, Waxman's health counsel, said Waxman believes federal funding should be allotted for comparative effectiveness studies, keeping in mind any studies by industry would be biased. "
Right and ALLHAT and CATIE were models of objectivity and have told us so much. Five years and $100s of millions of dollars later. Say goodbye to all new medicines.
Henry Waxman and Tom Cruise...perfect together.
We all know Tom Cruise "jumped the shark" when he jumped Oprah's couch in a demonstration of his love for Katie Holmes and started his one person tour disgrace against psychiatry. So now Tom is known for one note, unscientific attack on psychopharmacology and his effort to resurrect his career appears be Mission Impossible
Now meet Marcia Angell, the Tom Cruise of Health Care Policy. Ms. Angell's career had clearly jumped the shark with the publication of a poorly written and scientifically indefensible book "The Truth About Drug Companies" which had one main point: most drugs developed by pharmaceutical firms are just copycats that have no real clinical value to patients and those that do were developed by the government or academics without any biotech or pharmaceutical company input.
Now in the face of mechanistic evidence that different drugs in a therapeutic not only provide clinical benefit to different groups of people based on genetic variation but will be the foundation of drug development in the future, Angell persists in pushing her outdated and dangerous message. Thus, her uncomfortably silly letter in the New York Times this weekend.
To the Editor:
You refer to ''me too'' drugs as offering ''a merely incremental advance over some existing therapy,'' but there is no reason to think that they offer any advance at all.
In the clinical trials required for approval by the Food and Drug Administration, manufacturers do not have to compare ''me too'' drugs with old drugs in the same class, only with placebos.
For all we know, then, each new ''me too'' drug may be worse than existing ones. "
Yes, Marcia that's exactly what the body of clinical evidence shows. The first medicine developed was great and all the rest are incrementally worse than the next and actually make people sicker.
Does being a pathologist mean you are pathetic?
Now meet Marcia Angell, the Tom Cruise of Health Care Policy. Ms. Angell's career had clearly jumped the shark with the publication of a poorly written and scientifically indefensible book "The Truth About Drug Companies" which had one main point: most drugs developed by pharmaceutical firms are just copycats that have no real clinical value to patients and those that do were developed by the government or academics without any biotech or pharmaceutical company input.
Now in the face of mechanistic evidence that different drugs in a therapeutic not only provide clinical benefit to different groups of people based on genetic variation but will be the foundation of drug development in the future, Angell persists in pushing her outdated and dangerous message. Thus, her uncomfortably silly letter in the New York Times this weekend.
To the Editor:
You refer to ''me too'' drugs as offering ''a merely incremental advance over some existing therapy,'' but there is no reason to think that they offer any advance at all.
In the clinical trials required for approval by the Food and Drug Administration, manufacturers do not have to compare ''me too'' drugs with old drugs in the same class, only with placebos.
For all we know, then, each new ''me too'' drug may be worse than existing ones. "
Yes, Marcia that's exactly what the body of clinical evidence shows. The first medicine developed was great and all the rest are incrementally worse than the next and actually make people sicker.
Does being a pathologist mean you are pathetic?
News from today's Pink Sheet is that FDA Deputy Commissioner Scott Gottlieb will leave the agency in January. Bad news for the agency. But the good news is that Scott Unteathered will remain a potent force for the advancement of America's health through, we are sure, many important new endeavors.
On the same topic of “it’s all about the way you ask the question.†How do you think Americans would respond to these polling queries:
Q: Do you want the government to use its muscle to lower the price of gasoline?
Q: Do you want the government to use its muscle to lower the price of foreign imports?
Q: Do you want the government to use its muscle to lower the price of cars?
Q: Do you want the government to use its muscle to lower the price of meat?
Q: Do you want the government to use its muscle to lower the price of box seats at Yankee Stadium?
It’d be pretty easy to get an 85% “yes†rate to any of those questions – unless, per the last one, you’re a Red Sox fan.
So, rather than asking, as the Kaiser Family Foundation did, “Do you think the government should use its buying power to negotiate drug prices,†perhaps we should ask …
Q: Do you favor government price negotiations if it means you will not be able to receive the medicine your doctor has prescribed?
Q: Do you favor price negotiations if it means reducing investment in stem cell research and cures for cancer?
or ...
Q: Do you favor price negotiations even though the non-partisan GAO has reported that government price negotiations will not lower drug prices?
Field our own survey? Maybe we’ll do just that.
Q: Do you want the government to use its muscle to lower the price of gasoline?
Q: Do you want the government to use its muscle to lower the price of foreign imports?
Q: Do you want the government to use its muscle to lower the price of cars?
Q: Do you want the government to use its muscle to lower the price of meat?
Q: Do you want the government to use its muscle to lower the price of box seats at Yankee Stadium?
It’d be pretty easy to get an 85% “yes†rate to any of those questions – unless, per the last one, you’re a Red Sox fan.
So, rather than asking, as the Kaiser Family Foundation did, “Do you think the government should use its buying power to negotiate drug prices,†perhaps we should ask …
Q: Do you favor government price negotiations if it means you will not be able to receive the medicine your doctor has prescribed?
Q: Do you favor price negotiations if it means reducing investment in stem cell research and cures for cancer?
or ...
Q: Do you favor price negotiations even though the non-partisan GAO has reported that government price negotiations will not lower drug prices?
Field our own survey? Maybe we’ll do just that.
Expect stories this weekend in the MSM with headlines like "Americans support government price negotiations for Medicare."
That's going to be the talking point most reporters will swallow from the new poll by the Kaiser Family Foundation. Drugs from Canada too! Quelle surprise.
But here's the real story, buried at the end of the report:
When asked what overall message about the drug benefit they would "send to Washington," 12 percent of seniors said the benefit is working well and no real changes are needed, while 41 percent said it could be improved with some minor changes. Meanwhile, 28 percent said it's not working well and needs major changes. Ten percent said the program should be repealed.
Here's how I'd cume that: 53% say Part D needs some minor changes. 28% say "big changes." 10% say "ditch it."
But the "headline" finding of the report says that about 85 percent of seniors want to let the government use its buying power to negotiate drug prices, including 65 percent who said they strongly favor such negotiations.
It's all in the way you phrase the question.
Remember: Research is like a bikini. What it shows you is interesting, but what it conceals is essential.
Who do you think has the mandate?
And what do you think Robert Pear will write? Hmm.
That's going to be the talking point most reporters will swallow from the new poll by the Kaiser Family Foundation. Drugs from Canada too! Quelle surprise.
But here's the real story, buried at the end of the report:
When asked what overall message about the drug benefit they would "send to Washington," 12 percent of seniors said the benefit is working well and no real changes are needed, while 41 percent said it could be improved with some minor changes. Meanwhile, 28 percent said it's not working well and needs major changes. Ten percent said the program should be repealed.
Here's how I'd cume that: 53% say Part D needs some minor changes. 28% say "big changes." 10% say "ditch it."
But the "headline" finding of the report says that about 85 percent of seniors want to let the government use its buying power to negotiate drug prices, including 65 percent who said they strongly favor such negotiations.
It's all in the way you phrase the question.
Remember: Research is like a bikini. What it shows you is interesting, but what it conceals is essential.
Who do you think has the mandate?
And what do you think Robert Pear will write? Hmm.
When torcetrapib clinical trial results were presented to Pfizer chairman Jeff Kindler, he did not equivocate. Despite the financial implications, the trials were stopped immediately.
Tough choice? Yes. But, more importantly, principled choice.
The principle? Patient safety. And, as my father used to say, it’s not a principle unless it hurts to stand by it.
Bravo.
I must have missed the words of congratulations from the IOM, Senator Grassley, and Sidney Wolfe.
Tough choice? Yes. But, more importantly, principled choice.
The principle? Patient safety. And, as my father used to say, it’s not a principle unless it hurts to stand by it.
Bravo.
I must have missed the words of congratulations from the IOM, Senator Grassley, and Sidney Wolfe.
Patrick Clinton, of Pharmaceutical Executive Magazine, reminds us of the following old joke -- A patient goes to the doctor and learns he needs surgery that will cost $10,000. "I can't pay it, Doc," he says. "That's OK," responds the doctor. "For a hundred bucks I can retouch your X-rays.
Fantasy or Evidence-based Medicine? You make the call.
Clinton uses this joke as a lead-in to an excellent opinion piece on AWP (Average Wholesale Price) and Medicare. He says what he means and it’s a worthwhile read.
Here’s the link:
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=382530
And here's the background: In the US District Court for the District of Massachusetts, Judge Patti Saris is hearing MDL 1456, a multi-jurisdiction case that charges 42 pharmaceutical companies (and likely more to come) with violating various RICO and deceptive-trade-practice acts by artificially inflating the Average Wholesale Price (AWP) they reported to Medicare.
Enjoy.
Fantasy or Evidence-based Medicine? You make the call.
Clinton uses this joke as a lead-in to an excellent opinion piece on AWP (Average Wholesale Price) and Medicare. He says what he means and it’s a worthwhile read.
Here’s the link:
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=382530
And here's the background: In the US District Court for the District of Massachusetts, Judge Patti Saris is hearing MDL 1456, a multi-jurisdiction case that charges 42 pharmaceutical companies (and likely more to come) with violating various RICO and deceptive-trade-practice acts by artificially inflating the Average Wholesale Price (AWP) they reported to Medicare.
Enjoy.
With all the self-indulgent holds removed, Andy von Eschenbach finally gets confirmed. If Andy's defense of the integrity of the scientific process and the FDA during the last Grassley contretremps is a signal of what we are in for, it suggests that he see his ultimate responsibility to the employees of the agency, to patients and the scientific community. And it suggests that he will seek to generate more respect for the scientific enterprise that undergirds FDA's activities and transformation. Finally, the FDA will have someone who can set an intelligent and responsible course for the future, one that integrates the Critical Path with post market safety concerns, something that neither Congress or the IOM panel seems interested in or capable of.
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.
