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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
Whether it’s said in an American accent or a more refined British one, what's most important is to accent the truth – comparative effectiveness is bad medicine when you use healthcare technology assessment (HTA) tools (aka "Evidence-based Medicine") that misuse and misrepresent data derived from RCTs. Doing so yields results that budget managers want – regardless of whether or not it yields what’s best for the patient.
It’s the choice of short-term, short-sighted politicians.
Consider what’s going on in the UK.
The Association of the British Pharmaceutical is fighting proposals by the Office of Fair Trading to overhaul the pharmaceutical price regulation scheme so drugs companies will be forced to evaluate the benefit to the patient and the National Health Service when they set the prices.
Richard Barker, ABPI director-general, called the OFT's proposals "dangerous and anti-innovative". "The OFT has failed to understand the nature of scientific progress is step by step," he said, arguing that without a commercial incentive to introduce incremental improvements, more significant breakthroughs in new medicines would not take place.
He said the industry's two principal demands were to enhance the methods used for "health technology assessment", which would scrutinize the efficacy and cost benefits of new medicines; and to boost the often poor "uptake" of new medicines recommended by the National Institute for Clinical Excellence, the medicines advisory body.
His comments came ahead of hearings set to begin in the coming weeks by the Commons' health committee on the operation of the institute, which is studying why the agency's decisions are increasingly being questioned and whether public confidence in the organization is waning.
MPs will discuss the evaluation process and whether any particular groups are disadvantaged by the process, the speed of publishing guidance, the appeal system, comparison with the work of its Scottish counterpart, and implementation of its guidance.
Here’s the full story from the Financial Times:
http://www.ft.com/cms/s/88cd12b8-f2c8-11db-a454-000b5df10621.html
It’s the choice of short-term, short-sighted politicians.
Consider what’s going on in the UK.
The Association of the British Pharmaceutical is fighting proposals by the Office of Fair Trading to overhaul the pharmaceutical price regulation scheme so drugs companies will be forced to evaluate the benefit to the patient and the National Health Service when they set the prices.
Richard Barker, ABPI director-general, called the OFT's proposals "dangerous and anti-innovative". "The OFT has failed to understand the nature of scientific progress is step by step," he said, arguing that without a commercial incentive to introduce incremental improvements, more significant breakthroughs in new medicines would not take place.
He said the industry's two principal demands were to enhance the methods used for "health technology assessment", which would scrutinize the efficacy and cost benefits of new medicines; and to boost the often poor "uptake" of new medicines recommended by the National Institute for Clinical Excellence, the medicines advisory body.
His comments came ahead of hearings set to begin in the coming weeks by the Commons' health committee on the operation of the institute, which is studying why the agency's decisions are increasingly being questioned and whether public confidence in the organization is waning.
MPs will discuss the evaluation process and whether any particular groups are disadvantaged by the process, the speed of publishing guidance, the appeal system, comparison with the work of its Scottish counterpart, and implementation of its guidance.
Here’s the full story from the Financial Times:
http://www.ft.com/cms/s/88cd12b8-f2c8-11db-a454-000b5df10621.html
There is an old joke about the definition of chutzpah being someone who kills his parents and then asks for mercy from the judge because he's an orphan.
Now we have the journalist equivalent. Alex Berenson has an article in today's NYT: "US Wonders If Drug Data Was Accurate." You might recall Berenson helped ferret documents in violation of a court order to help build a biased case against Eli Lilly about well known side effects about Zyprexa and who was slammed by Judge Harvey Weinstein for doing so. And now he is writing about Zyprexa using the same documents he stole. Once again, Berenson uses the "one paper out of several thousands of documents" approach to depict Lilly as a criminal corporation.
And then at the end of the article Berenson writes: "A federal judge has criticized The Times for violating a protective order that covered the documents."
C'mon Alex we can be more accurate. We have the actual transcript describing YOUR behavior without violating the protective order. Didn't Judge Weinstein describe what you did as conspiring " to obtain and publish documents in knowing violation of a court order not to do so, and that they executed the conspiracy using other people as their agents in crime."
And as another report noted, Weinstein further described the actions of the men as "illegal," "stealing," a "brazen flouting" of his order and, in the case of Berenson, "reprehensible." He took occasion to quote from a 2004 version of the Times' handbook on ethical journalism: "Staff members must obey the law in pursuit of news."
On the heels of intense criticism of the NYT coverage of the Duke rape case and the paper's falling earnings, the Berenson reporting is another example of the Times decline.
Now we have the journalist equivalent. Alex Berenson has an article in today's NYT: "US Wonders If Drug Data Was Accurate." You might recall Berenson helped ferret documents in violation of a court order to help build a biased case against Eli Lilly about well known side effects about Zyprexa and who was slammed by Judge Harvey Weinstein for doing so. And now he is writing about Zyprexa using the same documents he stole. Once again, Berenson uses the "one paper out of several thousands of documents" approach to depict Lilly as a criminal corporation.
And then at the end of the article Berenson writes: "A federal judge has criticized The Times for violating a protective order that covered the documents."
C'mon Alex we can be more accurate. We have the actual transcript describing YOUR behavior without violating the protective order. Didn't Judge Weinstein describe what you did as conspiring " to obtain and publish documents in knowing violation of a court order not to do so, and that they executed the conspiracy using other people as their agents in crime."
And as another report noted, Weinstein further described the actions of the men as "illegal," "stealing," a "brazen flouting" of his order and, in the case of Berenson, "reprehensible." He took occasion to quote from a 2004 version of the Times' handbook on ethical journalism: "Staff members must obey the law in pursuit of news."
On the heels of intense criticism of the NYT coverage of the Duke rape case and the paper's falling earnings, the Berenson reporting is another example of the Times decline.
Pfizer's New combo drug-diagnostic for HIV got through the FDA Adcomm... I still wonder what prompted the FDA to dump all the safety concerns ahead of the commitee meeting?
http://blogs.wsj.com/health/2007/04/24/pfizer-aids-drug-gets-fda-panel-support/
http://blogs.wsj.com/health/2007/04/24/pfizer-aids-drug-gets-fda-panel-support/
The FDA announced today that all supplements and products derived from kryptonite would have a black box warning. Dr. David Graham had pressured the agency after noting that the presence of kryptonite would pose a serious and life threatening danger to Superman, Supergirl and other survivors of the planet Krypton. Graham had been pushing Congress to expand it's drug safety program to move beyond "merely planetary surveillance activities" and into galactic exploration of pharmacovigilance matters. The FDA said in a press release " this pilot project is part of our effort to develop a global and indeed galactic risk management program." The agency had planned to establish this program in partnership with Luthor Industries and the Justice League of America but was attacked by members of Congress for being too "cozy" with special interests.
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.
