Latest Drugwonks' Blog
While the “universal” consensus was that ethics are primary – economics came in a very close second. One robustly debated theme was the idea of “an ethical standard based on resources.”
The New York Times reports that,
"A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators."
Point One: How did a phrase like "fuel an explosion" make it past an editor? This is journalism?
The Times continues,
"By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at
Okay - that's the genesis of the story - Drs. Biederman and Wilens didn’t fill out their disclosure forms properly. They should know better. Transparency is a serious business that needs to be taken seriously - and they deserve to be taken to task for their bureaucratic ineptitude.
That's what Senator Grassley is upset about - and it serves as a timely anecdote in support of the physician sunshine legislation he's pursuing. But there are other agendas at play here - and Senator Grassley is being played (unwittingly one hopes) like the proverbial violin. When it comes to Conflicts of Interest, its COI polloi.
The not-so-hidden agenda is that anyone who supports the use of psychiatric pharmaceuticals for any reason needs to be humiliated and destroyed.
In that respect this is all about a new definition of R&D. Now it means RICO and Destruction.
Here's how the Times smoothly segues into this, far more nefarious story,
"The Harvard group's consulting arrangements with drug makers were already controversial because of the researchers' advocacy of unapproved uses of psychiatric medicines in children."
Already controversial? Really? According to whom? The Times doesn't every really say. The article's only mysteriously refers to”experts," as in "experts say." Maybe they're part of the New York Times expert witness protection program.
And the one person they do quote represents an activist group with an anti-medication agenda,
"Longtime critics of the group see its influence differently. "They have given the Harvard imprimatur to this commercial experimentation on children," said Vera Sharav, president and founder of the
This despite the fact that deeper in the story the Times casually mentions that, "The Grassley investigation did not address research quality."
There's a lot of that going on. A lot of what the Grassley investigation did not address. To wit, the Times adds that, "Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money."
And consider this paragraph,
"In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists; their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen."
Another example of amazingly bad editing. Marketing department "brethren?" "Terrific pitchmen?" Do these words belong in a news story outside of third party quotations?
Somebody should bring this to the attention of the New York Times Ombudsman.
The goal of Vera Sharav and her "brethren" is to scare away any research grants from anyone who supports the use of pharmaceutical treatment for psychiatric disorders. Let's face it, this story didn't come up because Senator Grassley's staff was looking at disclosure forms alphabetically and just happened to reach the Bs. There's no such thing as a coincidence when it comes to an opportunity to attack top tier researchers who accept pharmaceutical industry funding.
Unable to win on merit, activists go to motives. And the article seems to fall all over itself going back and forth between referring to how "world renowned" Bierderman and Wilens are while repeating and magnifying the insinuation made by the skeptics that, "for money," world class researchers are willing to aid and abet greedy pharmaceutical companies, "disease mongering" to create a Brave New World.
Here's a link to the complete story:
http://www.nytimes.com/2008/06/08/us/08conflict.html?scp=1&sq=biederman&st=nyt
Consider the comments of the only named "expert," Dr. E. Fuller Torrey, the executive director of the Stanley Medical Research Institute. It isn't even a comment on the quality of the Biederman/Wilens research. "In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money."
Certainly more money is needed - but why is government money any better than industry money? Should perception, rather than data, drive science? That's the agenda. It's frightening.
And so is McCarthyism.
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.
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.
