Latest Drugwonks' Blog

On the Mark

  • 09.20.2007
MarkMonitor that is.

Congress may soon consider legislation that would allow Americans to buy prescription drugs from foreign countries. Lawmakers who plan to vote for it should first read a new report on online pharmacies published by the respected Internet fraud expert MarkMonitor.

Published in August while Congress was on vacation, it found that of the 3,160 online pharmacies it studied, almost all of them were likely selling fake medicine.

This shocking finding should cause the congressional supporters of drug importation to change their minds, as many of their constituents will be turning to such websites for their prescriptions if the bill becomes law.

Here's a taste:

"The FDA has caught a number of pharmacies that claimed to be based in Canada -- but were operated out of China and sold medicine that was manufactured there. It's not clear how many online pharmacies are doing this, but anecdotal evidence suggests that the number is large. MarkMonitor found that 18 percent of the Web sites it evaluated were based in China, and that 12 percent were in the former Soviet Union."

And here's a link to an op-ed from today's Detroit News ...

http://www.detnews.com/apps/pbcs.dll/article?AID=/20070920/OPINION01/709200323/1008

Unsafe online pharmacies would be among the first to capitalize on legalized importation. If Americans care about their safety, they ought to log off online pharmacies. And lawmakers ought to shut down their push for drug importation.

On the Money

  • 09.20.2007
Last night, on the CNBC program "On the Money, Betsey McCaughey (Hudson Institute) and me were interviewed by Melissa Francis on "the drug dilemma" -- whether or not drug companies are doing enough to explain potential side-effects of their products.

Here's the video link:

http://www.cnbc.com/id/15840232?video=522416099&play=1

On the money? You decide.
Peter and I received inquiries about where CMPI received our funding from a nice young man from Senator Byron Dorgan's office name Ben Klein. We both spoke to him and told Ben as we have told everyone that CMPI receives the bulk of our support -- proudly -- from pharmaceuetical and biotech firms that do the heavy lifting in the search for better medicines and search for cures. We are forthright and transparent in that respect. We offered to send a 990 once it's complete... a real one made in the USA, not imported from Canada.

We believe in disclosure and transparency and in that spirit, here's where Senator Dorgan got his money for his 2004 campaign....



Agribusiness $127,180
Communic/Electronics $442,767
Construction $26,300
Defense $57,998
Energy/Nat Resource $181,266
Finance/Insur/RealEst $458,100
Health $161,400
Lawyers & Lobbyists $562,214
Transportation $148,864
Misc Business $303,683
Labor $345,000
Ideology/Single-Issue $211,255
Other $83,360

http://www.opensecrets.org/races/sector.asp?ID=NDS1&cycle=2004&special=N

So the next time Dorgan talks issues someone should question his integrity by asking him if he gets support from such and such industry first.....

And here is where he spreads the pork... earmarks include $350,000 for leafy-spurge eradication efforts and $200,000 for the International Peace Gardens. In North Dakota? How about my backyard to replace the poison sumac?

And just so we know what the Dorgan standard for disclosure is, let's go back to 2005 when he was holding court on the Abramhoff scandal and "forgot" to disclose how he used Jack's corporate box as a fundraiser and pocketed campaign contributions that, while legal, gave the appearance of a conflict of interest...

From the Boston Globe in 2005...

The Democrat helping to lead the Senate investigation into Jack Abramoff's Indian lobbying had his own connections to the controversial lobbyist's team and clients, including using his sports arena skybox to raise money.
Senator Byron Dorgan, a North Dakota Democrat, acknowledges he got Congress in fall 2003 to press government regulators to decide, after decades of delay, whether the Mashpee Wampanoag tribe of Massachusetts deserved federal recognition.

Dorgan met with the tribe's representatives and collected at least $11,500 in political donations from Abramoff partner Michael D. Smith, who was representing the Mashpee, around the time he helped craft the legislation, according to interviews and documents obtained by the Associated Press.

The senator also didn't reimburse another tribe, the Mississippi Choctaw, for the use of Abramoff's skybox in 2001, when the tribe held a fund-raiser for him there, instead treating it as a tribal contribution. He only recently reimbursed the tribe for the box, four years later, after determining it was connected to Abramoff.

Dorgan, who is vice chairman of the Senate Indian Affairs Committee that is investigating Abramoff, says he sees no reason to step down from the probe, which he and Senator John McCain, an Arizona Republican, are leading. He said he had no idea at the time that any of the transactions were connected to Abramoff or the alleged fleecing of tribes.

''I never met Jack Abramoff, but I am appalled by what we have learned about his actions," Dorgan said Thursday. ''So I have never felt there was any conflict in my helping to lead that investigation. I think Senator McCain would agree our investigation has been relentless and that neither of us will be diverted."

Dorgan's contacts, donations, and fund-raisers involving Abramoff tribal clients and lobbying associates, as well as those of other lawmakers, have not been examined during the Senate hearings into the lobbyist's roughly $80 million in charges to the tribes.

The senator didn't volunteer the information, although he did disclose his donations in campaign reports over the years.

Larry Noble, the government's former chief election enforcement lawyer, said Dorgan should have considered stepping aside from the inquiry and should have disclosed all his own intersections with Abramoff's associates and tactics.

''I think any way you look at it, he had an obligation to disclose," Noble said. ''It is hard for anyone not to see a conflict when you're investigating the same activity you yourself were involved with."

Over the past month, the AP has reported that about four dozen lawmakers, Republicans and Democrats, collected donations from Abramoff's tribal clients and firm around the time they wrote letters to the Bush administration or Congress favorable to the tribes.

Congressional ethics rules require lawmakers to avoid even the appearance of a conflict of interest in performing official duties and accepting political money. The Justice Department is investigating whether Abramoff, already charged with fraud in a Florida case, won any undue influence through donations and favors.

Dorgan on Monday sharply criticized the AP for reporting last week that he collected $20,000 from Abramoff's firm and tribes in the period when he wrote a letter urging the Senate Appropriations Committee to fund a school construction program that Abramoff's clients and other tribes wanted.

The senator, who has Indian tribes in his state, said he long supported the program and the letter and donations had no connection.

He asserted that he never took any action or received campaign help that knowingly involved Abramoff.

Dorgan's office acknowledged he met in 2003 with representatives of the Mashpee, the Massachusetts tribe that Abramoff signed as a client and Smith represented.

The senator used his position as a member of the joint House-Senate committee that approved the final Interior Department spending bill for 2004 to craft a provision that pressed the agency to ''complete its review of the Mashpee petition as expeditiously as possible."

http://www.boston.com/news/nation/washington/articles/2005/12/03/abramoff_prober_had_ties_to_lobbyist/

Hope we've been helpful Senator. Let's have lunch soon.
That's Bridges as in John FP Bridges, CMPI Senior Fellow and Assistant Professor, Department of Health Policy & Management at the Johns Hopkins Bloomberg School of Public Health.

John has co-authored a very timely, important and intriguing new paper in The Expert Review of Pharmaceoeconomic and Outcomes Research, "Promoting patient empowerment in the healthcare system: highlighting the need for patient-centered drug policy."

Timely because it coincides with many Presidential candidates releasing their plans for revitalizing the American health care system.

Important because the paper seeks to define precisely what "empowerment" means and identify its constituent variables.

And intriguing because, well, it is.

Here's what Bridges, et al consider the "Antecedents to Empowerment" ...

* Knowledge
* Health Literacy
* Patient Initiative
* Access to Services and Drugs

And "Activities for Empowerment" ...

* Information Sharing
* Doctor-Patient Communication
* Choice
* Shared Decision Making

And, as a result, the "Outcomes of Empowerment" ...

* Health Status
* Patient Satisfaction
* Self-Efficacy
* Adherence

Here is a link to the complete article:

Download file

Viva Bridges!
There are some bloggers anxious to absolve themselves of responsibility for the jump in suicides because of SSRI related fearmongering who are claiming that the 2004 data is just a blip.

Nice try with incomplete data. The jump in suicides was pronounced among youths but increased across ages 10-64 from 2003-2004. The jump in 2004 came after a 15 year decline among kids. And if the suicide rate decline in 2005 -- which I hope is the case -- holds up among kids specifically it only goes to show that the fearmongering was the principal factor not the other way 'round.

At least such pundits like Phil Dawdy of Furious Season with whom I rarely agree but whose trenchant style I admire are seeking to offer an alternative and plausible data-driven explanation. http://www.furiousseasons.com

They are not claiming -- like David Healy -- that the jump is a result of treating kids with atypicals. Healy, who is now a paid consultant to the trial bar suing Lilly and other companies who make such drugs has no shame. What a tool.

Hard Evidence

  • 09.18.2007
From The Times of London ...

Fake world of the Viagra plotters

For tens of thousands of men the medicines offered by Ashish Halai and his gang appeared to be the answer to two of their most worrying and embarrassing health concerns: impotence and baldness.

But the unsuspecting customers, buying what they thought were Viagra and Propecia, were victims of one of the most ambitious and elaborate of counterfeiting crimes. Halai and his associates were buying fake drugs from Chinese suppliers for as little as 25p a tablet and selling them for up to £20.

Details of their vast network – stretching from Britain to Hong Kong, Dubai, the US and the Bahamas – emerged yesterday as justice finally caught up with the conmen.

In the largest drug counterfeiting case in Britain, and after a trial lasting more than seven months, Halai, 33, was jailed at Kingston Crown Court for four and a half years as one of the key players in the plot.

From his £1 million home in Borehamwood, Hertfordshire, he helped to mastermind an operation in which fake pills were produced at secret factories in China and Pakistan and smuggled to the US and Europe. The rewards, the court was told, were “immense”.

The investigation, the largest conducted by the Medicines and Health-care products Regulatory Agency (MHRA), uncovered profits of more than £2 million. The agency said that this was the “tip of the iceberg”.

“The geographical spread was global and the financial rewards were immense,” Sandip Patel, for the prosecution, told the court.

The case dates back to 2003 and 2004, when counterfeit batches of Viagra and Cialis, impotence drugs made by Pfizer and Eli Lilly, were seized while being smuggled into Heathrow and Stansted airports.

The MHRA immediately launched an investigation which alerted them to a major manufacturing and smuggling operation. Samples showed that the medicines contained about 90 per cent of the active pharmaceutical ingredients found in genuine tablets. Most of the fake pills were sold via the In 2003 the MHRA contacted the US Food and Drug Administration, which seized 8,000 packages of Viagra in Miami. Then, in July 2003, MHRA officers seized more than 120,000 fake Viagra tablets. internet, but some found their way into chemists were they were sold as prescription medicines.

The full story can be found here:

http://www.timesonline.co.uk/tol/life_and_style/health/article2477868.ece?EMC-Bltn

Caveat emptor is not sound health care policy.
See what I mean?

This is a lot better than bureaucrats guessing...

http://ap.google.com/article/ALeqM5iX6mwtAXZaZ-NdJ3C9SQh4nOBrqQ
Genomas has lead the way to identifying the genetic links to painful side effects associated with statins. (I was honored to have been able to use their gene chip to guide my selection of statins.) This is the right and cost effective way of optimizing drug selection...


"Research by Genomas and collaborators at Hartford Hospital, University of California San Francisco and Yale has demonstrated a strong association between myalgia (muscle pain) arising during statin treatment and variability in genes related to pain perception. The research has been published in the September issue of the leading neurological journal Muscle and Nerve*, published by Wiley InterScience. The findings suggest that serotonergic neurotransmitter receptor function may contribute to the muscle pain induced by statins in some patients inheriting specific variants of the receptor genes. "

For more information go to http://www.genomas.net
Steve Usdin makes the point in this week's Biocentury that companies who fail to come up with personalized algorithms for dosing and medicines will find themselves at the mercy of micromanagers and second-guessers at FDA panels, CMS and cost cutters generally. But the challenges, legal, economic, regulatory are great in this era of of no good deed going unpunished or sued. As Usdin writes "These studies, along with observational data, paint a complex, nuanced picture. Indeed, the panel members spent much of the meeting focused on an apparent paradox: attempting to increase Hb in kidney disease patients to levels approximating those in healthy individuals is harmful, but actually achieving higher Hb levels is usually beneficial.
The committee also grappled with the potential association between increased mortality risk and low response rates to ESAs, a circumstance that could affect as many as 40% of dialysis patients."

So much for the value of randomized trials in personalizing dosing regimens.


Meanwhile, as if we did not need another reminder that it won't stop at ESAs, Biocentury has a story about how patients waiting for Revlimid in the UK will have to wait years to produce comparative effectiveness data of the sort that Hillary's Best Practice Institute will generate.

According to Biocentury:

"Multiple myeloma patients in the U.K. will have only limited
access to one of the newer drugs for the disease, Velcade bortezomib, as a result of NICE’s recent recommendation to shave the number of patients who would be indicated for the drug. And they will have limited access in the foreseeable future
to another new drug, Revlimid lenalidomide from Celgene Corp., which is in no hurry to undergo the NICE process..."

Who can blame them, because it takes at least a year and, in the case of the UK, years to get reimbursement approval.

The pace is going to be slower in the U.K. Although Revlimid is available to patients who have private insurance, going through the country’s reimbursement
process is not near the top of CELG’s list because NICE takes such a long time.
Indeed, Gill said the company does not even have a timeline for when it will begin the process. “We will work with NICE as expeditiously as possible, but historically it takes years.”

Best Practice Indeed
Two U.S. Department of Health and Human Services agencies will collaborate in the most comprehensive study to date of prescription medications used to treat attention deficit hyperactivity disorder (ADHD) and the potential for increased risk of heart attack, stroke or other cardiovascular problems.

Thank you Dr. Nissen and Dr. Furberg....

AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

Researchers supported by the Agency for Healthcare Research and Quality and the U.S. Food and Drug Administration will examine the clinical data of about 500,000 children and adults who have taken medications used to treat ADHD, to determine whether those drugs increase cardiovascular risks.

Because medications used to treat ADHD can increase heart rate and blood pressure, there are concerns about the drugs' potential to increase cardiac risks. It is also thought these risks may be different for adults and children, but more evidence is needed about the long-term effects of using ADHD medications.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01700.html
CMPI

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.

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