Latest Drugwonks' Blog
There are four basic reasons:
(1) It won’t save any money.
(2) The drugs being sent to U.S. customers from Canadian Internet. pharmacies are not “the same drugs Canadians get.”
(3) The state experience has been dismal and politically embarrassing.
(4) National Security concerns.
(For more detail on these points click here: www.drugwonks.com/blog_post/show/5011)
Adding fuel to the reality is a new report just made public at the conference, by the European Alliance for Access to Safe Medicines (www.eaasm.eu). The title says it all, “The Counterfeiting Superhighway.”
The report reveals the scope of the unregulated trade of fake pharmaceuticals. Through extensive research and examination of over 100 online pharmacies and over 30 commonly purchased prescription-only medicines, the report makes one thing very clear – we’re not winning the battle.
Key findings from this report
• 62% of medicines purchased online are fake or substandard (including medicines indicated to treat serious conditions such as cardiovascular and respiratory disease, neurological disorders, and mental health conditions).
• 95.6% of online pharmacies researched are operating illegally.
• 94% of websites do not have a named, verifiable pharmacist.
• Over 90% of websites supply prescription-only medicines without a prescription.
• 78.8 of websites violate intellectual property.
My favorite anecdote is the report’s example of an Internet pharmacy whose products came wrapped in pages from the Mumbai Daily News. The most frightening fact, though, is most of the fake medicines “were delivered in seemingly authentic boxes, accompanied by patient information leaflets in good condition and ostensibly trustworthy blister packs.”
The report concludes by providing recommendations based on the research findings and calls all stakeholders including search engines, credit card companies, shipping companies, patient groups and regulators, to take action and halt this dangerous trend.
Bravo.
The full report can be found at www.eaasm.eu/Media_Centre/News/The_Counterfeiting_Superhighway)
Drug importation is not on their list of solutions.
The take-away for U.S. electoral rhetoric is obvious – Senator McCain and Senator Obama cannot be for enhanced drug safety and for drug importation. It’s simply does not compute.
"Patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries,” Waxman said during a hearing last month on issue. "The result is that one of the most powerful incentives for safety -- the threat of liability -- would vanish."
Okay – once more with feeling, not true. When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, federal preemption does not protect the manufacturer – and they should be held accountable. The threat of litigation can be an important disincentive to such irresponsible behaviors.
The U.S. Chamber of Commerce's Institute for Legal believes that federal law should trump state statutes when there are inconsistencies between the two. It further argues that preemption allows companies that conduct business in different states one set of rules for compliance, instead of a hodgepodge of laws that stifle growth.
As it should be. Why make being “in compliance” difficult. Doesn’t that ultimately hurt consumers?
An important point to remember is that The FDA’s legal authority over labeling for prescription drugs and biological products is plenary. The Federal Food, Drug, and Cosmetic Act establishes mandatory and prohibited labeling content and manufacturers have no choice but to comply with these requirements. Less obvious, but equally important, is the principle that the Act also constitutes a “ceiling.” In other words, a manufacturer cannot add risk information to labeling unless the FDA has specifically granted its permission.
There is some hope for sanity.
"Current preemption policy is nothing novel or radical, but a dynamic response to an increasingly litigious environment that undermines the effectiveness of the long-established FDA regulatory system," said House Oversight and Government Reform ranking member Tom Davis.
Amen.
Watch this space for more details.
“IRONICALLY enough, the dangers of the liberal health-care agenda are being made clear by the care that a liberal icon, Sen. Ted Kennedy, has received since his brain seizure last month.”
And here’s a link to the complete article:
Read New York Post article
A worthwhile and disturbing read.
Caveat Emptor.
Yes – this is the same government that flaunts its disregard for intellectual property rights for, you got it, biopharmaceutical companies!
As Yul Brynner commented in The King and I, “is a puzzlement.”
The ministry's announcement of its pro-biotechnology policy came ahead of the June 17-20 Convention of the Biotechnology Industry Organizations (BIO2008) in San Diego.
Satit Chanjavanakul, secretary-general of the Office of the Board of Investment, said the office has already granted investment privileges worth over 19.5 billion baht to about 45 biotech companies.
''We are trying to attract more investment in this promising field by offering tax privileges to any company investing in biotechnology research and development,'' he said.
Okay, three questions:
1. Is the ministry oblivious to or ignorant of what investors in the biotech sector seek and need-- like the primacy of IPR for innovative research?
2. Is the ministry unaware of the high profile compulsory licensing done by their own health ministry? Is this possible?
3. Or is this effort just a form of (very cheeky) damage control?
Let’s go with cognitive (cheeky) dissonance as in, “Yes, you as an investor are vulnerable to us seizing your property. And, yes, please come and transfer your technology, invest in our country, because we are offering certain advantages to you!"
If Thailand wants to become a biotech hub, they’re going to have to do more than … whistle a happy tune.
Today, accounts and results are far from conclusive ; and this includes healthcare policy where reform is largely non-existent ; words are not deeds.
A recent article in the Quotidien du Médecin (weekly for health professionals) wrote last week : « Indeed, the system of co-payments, vigorously opposed by public opinion, has been implemented but that’s about it. For the rest – be it hospitals, private sector physicians, financing of the public health insurance or the announced revolution through regional health authorities – we are kindly asked to await the autumn or even 2009. »
Well said. In truth, any wholesale reform of « the world’s best system » will have to tackle awesome vested interests, both private and public. Which is why the government is loath to launch any radical initiatives. As in education, the nominal « private » sector remains heavily tied to state authorities. And although reports have shown, quite recently, that productivity is substantially higher in the private hospital sector, the administration consistently squeezes private provision of health care.
And as for being world champion a couple of years ago (in the EHCI index:
www.healthpowerhouse.com/archives/cat_media_room.html
France slipped to third place this year. Something is happening ; let’s hope policy makers have noticed.
Sad news is no less sad when you know its coming.
The New York Times reports that, “Most medical schools the United States fail to police adequately the money, gifts and free drug samples that pharmaceutical companies routinely shower on doctors and trainees, according to a ranking by the American Medical Student Association."
According to Dr. Brian Hurley, president of the AMSA, “These policies are incredibly important to protect the educational experience students have at school and the quality of the education they’re getting.” The Times reports that, "Schools that shield students from marketing messages will produce doctors who provide better care to patients, Dr. Hurley said."
Really? Why is that? No evidence provided. Just empty rhetoric but, since it’s in the New York Times, fit to print.
The Times’ story continues, “The role played by pharmaceutical and device makers in the education of doctors has become an increasingly controversial topic, with some top medical schools placing a growing number of restrictions on the longtime practice of providing free food, gifts and educational seminars to trainees.”
But, again, no facts to show why this isn’t anything more than a tempest in a teapot being brewed by the usual suspects.
And, speaking of the usual suspects – guess what public policy expert the Times quotes on the matter? Yup – Sid Wolfe.
“Most of the medical school bureaucracies are getting too much money and other forms of largess from the drug industry to initiate these healthy, long overdue policies on their own,” Dr. Wolfe said.
Here’s a link to the complete story in today’s Times:
http://www.nytimes.com/2008/06/03/health/03conflict.html?ref=health
Where’s the other side of the argument? Invisible in today's New York Times, but it’s there. It’s important. It’s not hiding. In fact, it’s easy to find and high profile.
Consider the recent op-ed in the Boston Herald by Dennis Ausiello and Thomas P. Stossel (both of
“… Despite extensive training, physicians cannot know the details of all products, especially new ones. Therefore, company salespersons complement physicians’ information derived from many sources. They tell physicians about a limited range of products about which their employers train them under strict FDA regulations.”
“… We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps.”
Here’s a link to their complete op-ed:
http://bostonherald.com/news/opinion/op_ed/view.bg?articleid=1087609
It wasn’t hard to find. In fact, it was made easier by the fact that Dr. Stossel testified in front of Congress on this issue – recently.
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.
