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Pfizer will directly fund basic research in an open-ended collaboration with Univ of Calif San Francisco..I hope this gives the connect dots crowd angina (that drugs developed through this deal with Satan can treat) so that they in turn can refuse them based on the Pharmalot principles:
1. Any drug developed by a collaboration with BIG PHARMA is by definition less effective and more dangerous than literature and FDA documents state and is more dangerous and less effective than bloggers, trial lawyers and unbalanced patients proclaim.
2. Any older drug is safer and more effective than any newer drug even though every older drug was developed in the same fashion as newer drugs.
3. Newer drugs are more dangerous and less effective older drugs because older drugs are made by generic companies who don't market products and newer drugs are approved by an FDA run by a Bush administration appointee.
4. Any research produced by anyone who has ever consulted with or conducted research for a biotech or pharmaceutical firm is tainted and the results, though reproduced and validated by scientific methods, are false.
5. Except Steve Nissen.
6. Or Curt Furberg
www.sfgate.com/cgi-bin/article.cgi
That would be the he Office of Criminal Investigations, the OCI. It seems that many of the usual suspect FDA-bashers (Senator Grassley, Mr. Stupack, Mr. Barton) are “concerned” that the OCI is being pressured to pursue some cases (like the abuse of scheduled medicines such as Oxycontin or ingredients for methamphetamine) while ignoring others (like the brouhaha over Ketek clinical trial oversight).
It's also important to mention the OCI's central role in fighting counterfeit drugs (aka: international healthcare terrorism). But saying "thank you" isn't in the current Congressional lexicon. Too bad. OCI's earned it many times over.
According to the Journal, “Mr. Grassley has already cut into OCI's autonomy. For nearly a decade, OCI worked under a little-known memorandum of agreement that gave OCI precedence over the Inspector General's office at Health and Human Services Department in conducting internal-affairs cases. That authority was withdrawn at the end of 2007 after Mr. Grassley complained that OCI selectively investigated FDA whistleblowers.”
There’s a difference between whistleblowers and felons. Note: Releasing internal FDA documents to the media is a felony.
As if the slight to the very hard working and dedicated OCI staff wasn’t bad enough – the WSJ article singles out the OCI’s director, Terry Vermillion, for particular abuse.
“Mr. Vermillion hasn't been made available for interviews. He came under fire from Democrats and Republicans last year when news reports revealed that large bonuses pushed his take-home pay for 2006 to $198,000, more than that of a member of Congress or a Supreme Court justice."
Note to Alicia Mundy: What about all those Congressional perks? They sure add up --and quite nicely. FDA perks are restricted to parking spaces at HQ. Sloppy reporting. (I assume the Supremes must have pretty nifty perks too.)
Terry is a tough mother you-know-what. Precisely the kind of guy you want running the FDA’s Office of Criminal Investigations. And I say that from personal, first-hand knowledge and experience.
Another shameful show trial? Yes. But what’s worse is that it continues to erode FDA morale and dampen esprit de corps -- just at a time when the agency (and the country) needs it more than ever.
Here are the first two paragraphs from his op-ed in today’s edition of the New York Post:
“FEW relationships are more personal - and private - than the one between patient and doctor. Unfortunately, this fact appears to be lost on
Gov. Paterson is now backing legislation designed to limit the influence drug companies wield over doctors. The goal may sound reasonable - but the bill itself would bring a massive and unnecessary government intrusion into individual medical decisions.”
Click here for the complete article
To see Dr. Weber discuss this and similar issues on a recent CMPI video podcast, click here:
As Dr. Weber writes, “Gov. Paterson means well in promoting these "reforms" - but he's wrong. The bill would only drive up medical costs by producing reams of added paperwork for doctors, patients and administrators alike.”
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.
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.
