No-Part Harmony

09/28/2007 07:27 AM |

The Patent Reform Act of 2007 (S. 1145) seeks to “harmonize” the American patent system with those of other nations. But, as Kevin Kearns of the U.S. Business and Industry Council has written, “do we really need to be "harmonized" with a calcified European system or the impossibly unfair Japanese system, not to mention the Chinese system, where intellectual property theft is a way of life?”

Bottom line is that the pending legislation would make it harder for patent holders to enforce their rights or win just compensation from those who infringe their rights. It would be harder to prove "willful" infringement, which entails punitive damages. The bill also includes a mandatory apportionment test that would lessen the value assigned to patents in most products.

Not only would the bill reduce the value of patents, but it would facilitate patent theft.

Under our current system, inventors can "opt-out" of having their application published by filing "only" in the United States and not in another country where it can be ripped off. The current bill would eliminate the opt-out provision.

Think “health care innovation.” Then think “India.”

According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without robust intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.

There are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits.

Does our patent system need reform? That’s a question for patent experts. Should we facilitate a patent system that disincentivizes pharmaceutical innovation? That’s a no-brainer.  Read More & Comment...

FDA Reform Act: Personalized Medicine vs The Plaintiffs Priesthood

09/27/2007 03:57 PM |

President Bush signed the FDA reform bill into law today. Now we'll see who gains control of the future of drug regulation: those who support personalized medicine and develop tools to make medicines safer and more effective by tailoring treatments to those best suited for them. Or the plaintiffs priesthood, the Grahams, the Avorns, the Nissens, the Furbergs who will cherry pick clinical trial data on the trial attorney/Soros/Public Citizen/ dime. The choice is between those who want to really reduce risk through better science and those who want to distort data to make us more afraid.  Read More & Comment...

Been There Done That (Critical Path)

09/27/2007 03:28 PM |

Our friends at the C-Path Institute have blazed that trail of personalized drug safety. Go to the C-Path website..it is full of initiatives and partnerships with the FDA. Ditto the folks at BG Medicine who have a CRADA with the FDA on a liver tox biomarker. Then there is the work of Dr. Ruano (that I have benefitted from directly -- put that in there because I know my critics just hate when I use personal examples ) with regard to side effects from statins at Genomas.

As Ray Woosley of C-Path asks about Personalized Medicine. When? Why Not Now?

http://www.cpath-institute.org
http://www.bgmedicine.com
http://www.genomas.net  Read More & Comment...

What Janet wants Janet gets

09/27/2007 09:39 AM |

From today's edition of the Wall Street Journal ...

Consortium to Study Genetics, Drug Safety
By JENNIFER CORBETT DOOREN


WASHINGTON -- A group of seven pharmaceutical companies and academic institutions today will announce an alliance designed to look for genetic links to safety problems associated with medicines.

The group, known as the International Serious Adverse Events Consortium, will launch two studies to look for genetic markers that researchers hope will predict which people are at risk for serious drug-related adverse events.

The first study, with results tentatively slated for release about a year from now, will look at whether variations in a person's DNA are responsible for the development of a rare drug-related skin condition known as Stevens-Johnson Syndrome. Stevens-Johnson is typically marked by a painful, blistering skin rash that causes the top layer of the skin to die. It can be fatal if a person is exposed to the drug that initially caused Stevens-Johnson again.

The second study will look at genetic variations behind serious drug-induced liver injury. Arthur Holden, a former Baxter International Inc. executive who is chairman of the consortium, said he hoped results from that study would be available in two years.

"Everyone's talking about drug safety, and this is what we need to do to improve drug safety," Mr. Holden said in an interview. The seven companies, Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer Inc., Roche Holding AG, Sanofi-Aventis SA and Wyeth are providing "millions" of dollars for the research effort, he said.

The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis. The DNA from the individuals with side effects will be compared with DNA from "control" subjects who didn't have drug side effects to see if there are genetic variations among the two groups.

Mr. Holden said that if the first two studies are successful, the consortium would then move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class.

The data from the consortium will be made public and could be used by government regulators such as the Food and Drug Administration.

Janet Woodcock, the FDA's chief medical officer, will work with the consortium, although the agency isn't formally a member. "We want this kind of information," she said of the genetic studies, so the agency can find ways to prevent drug side effects or to better manage them. Dr. Woodcock said it is possible that FDA regulations and guidelines on drug development and approval could change if the studies yield clear results.

Many serious drug side effects, such as an increased risk for heart attacks and strokes seen with Merck & Co.'s withdrawn painkiller Vioxx, don't become apparent until after drugs hit the market and thousands or millions more people are exposed. Most clinical studies used to gain approval for a drug involve several hundred to a few thousand patients.

Already, the FDA is highlighting genetic information to help doctors and patients manage drug side effects. Last month alone, the agency said as many as one-third of people on the blood-thinning drug warfarin metabolize the drug differently than expected and warned that breast-feeding women on painkillers with codeine could expose the infant to too much codeine if they are "ultra-rapid" metabolizers of the drug. However, the FDA stopped short of recommending that patients undergo genetic testing to see how they might process the drugs  Read More & Comment...

Comparative Effectiveness Conflicts

09/27/2007 08:53 AM |

I forgot to mention (because it's beaten into the mainstream mindset that only free market thinkers can be "conflicted")) that the comparative effectiveness crowd has some conflicts of their own, starting with the fact that they are funded by insurance companies. But I guess taking money from organizations that switch people from one molocule to another without telling patients is okay for bloggers like Health Care Renewal. The science linking statin response to genetic mutation is pretty compelling -- but maybe HCR wants to challenge the science in this area too?

Then there is the trial attorney/Soros/Avorn connection that is never disclosed. Drugwonks posted on that previously.

http://drugwonks.com/2007/02/iom_safety_committee_conflicted_and_confused.html  Read More & Comment...

Bad Medicine

09/27/2007 07:12 AM |

“If you want to save money and save lives, the "switching" we need in the United States is a one from a focus on acute care to one on chronic care.”

So begins a new op-ed in The Journal of Life Sciences.

The complete article can be found at:

http://www.tjols.com/article-289.html

To cut healthcare costs, we need to focus on early treatment of chronic conditions, rather than force patients to switch to generic alternatives that may not be equivalent to the medicines they are using.

The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.  Read More & Comment...

Health Care Renewal Defends Avorn, Defames Me

09/26/2007 11:14 PM |

Here's a weak effort to discredit my argument through misdirection and personal attacks. Only my kids can do that with any success.


http://hcrenewal.blogspot.com/2007/09/over-top-denunciation-of-comparative.html

I have posted my response below in case HCR doesn't see fit to publish it.

If you are going to attack me you had better have your facts right. Not even close.

1. You treat congestive heart failure with anti-hypertension drugs. Ask any doctor.

2. At the risk of being deliberately misconstrued again, I will refer you to the A-HeFT study and it's design which included BiDIl with OTHER anti-hypertensives to prolong survival from congestive heart failure.

3. As for the ALLHAT study, nice of you to ignore step 1. Let me quote Dr. Michael Weber who was an investigator in ALLHAT on the design of the study and it's impact on blacks..."it was poorly designed, the interpretations were disingenuous, it violated appropriate scientific reporting, and most frightening, it did something that was so unethical that if a pharmaceutical company had done it or any of us as individual academics had done it, we would not only be thrown out of our jobs, we would be pilloried and maybe even be facing criminal charges: And one thing that did show up in favor of diuretics, the fact that they cause fewer strokes than one of the other drug classes, was driven entirely by a 40% excess stroke rate in black patients that was predictable before the study began. "

Like I said Avorn attacked BiDil for being a lousy study but peddles his academic detailing plan and uses ALLHAT as a dispensing model.

You can try to sling mud about the fact that CMPI accepts grant from drug companies -- and we do so proudly because they actually invent things that help people -- but get your freakin facts right. If you don't know that hypertension drugs are used to treat heart failure don't talk about them. And I know a lot more about the ALLHAT situation then you ever will. What's nonsense is you trying apologize for a movement that places the cost of drugs over the quality of human life. As for the rest of the post, I am still waiting to see evidence that people are less interesting in hating drug companies than in helping people live. Most of the post are biased in that they believe drugs are part of the apparatus by which corporate capitalism maintains inequalities that harm society and the health care system. Keep drugs off the market and strike a blow for economic justice and health equity. If people die in the process so what? The end justifies the means. That is what drives the comparative effectiveness movement.  Read More & Comment...

Personalized Cancer Cures In Development...What Will CMS Knuckleheads Say

09/25/2007 10:30 AM |

Let's restrict access out of cost considerations and use safety as the excuse!!!

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/09/19/ncancer219.xml  Read More & Comment...

Sail on, sCHIP of State

09/25/2007 09:22 AM |

PRINCIPLES FOR REAUTHORIZATION OF sCHIP

From the Health Policy Consensus Group

* The primary focus of the State Children’s Health Insurance Program should be to cover children in families with incomes at or below 200 percent of poverty. States that wish to expand sCHIP to cover children and adults in higher-income families are free to do so with their own state funds.

For those above 200 percent of poverty, the appropriate federal mechanism for support is through a combination of tax reform and direct financial subsidies to help families purchase the private health insurance of their choice.

* The program’s subsidies should be re-structured to encourage the purchase of private health insurance. sCHIP subsidies could be used to allow parents to purchase the health coverage that they believe is best for their children, including adding them to policies that may be offered at their workplaces. Research shows that children and their parents benefit if the whole family is covered.

* The federal-state matching ratio for sCHIP funding should be changed to eliminate the distortions that exist in today’s system. States receive a higher federal matching rate for covering sCHIP recipients (which today include many adults) than they receive for covering children eligible for Medicaid, even though these Medicaid children are in families with lower incomes. Congress should focus on fixing the perverse incentives that reward states at a higher level for enrolling higher-income sCHIP children over poorer Medicaid children. The current funding formulas also mean more federal sCHIP dollars will go to wealthier states that can afford to expand the program than to poorer states that do not have sufficient state funds to expand their programs.

* sCHIP must not be turned into another entitlement program modeled after Medicaid, with unlimited federal funds matching state spending on benefits. That would add to the taxpayers’ already-overwhelming burden of tens of trillions of dollars in unfunded entitlement liabilities. It also would encourage states to use accounting tricks to inappropriately increase federal payments, as they have done for years in the Medicaid program. sCHIP must remain as a capped funding program to the states, and Congress must require states to live within their allocations.

Here is the complete Consensus Group statement:
Download file

Two-thirds of uninsured children are eligible for either sCHIP or Medicaid under current law, including many children under 200 percent of poverty who are not yet enrolled. Expanding sCHIP to children in higher-income families would mean shifting the focus away from these children who most need help and would grow the program into a middle-class entitlement that goes far beyond its current mission of helping near-poor children. Reauthorization of sCHIP should concentrate on reducing the number of near-poor children who are eligible for coverage.  Read More & Comment...

Let It (Not) Bleed

09/25/2007 07:22 AM |

Additional thoughts on warfarin, genetic testing and personalized medicine courtesy of Dr Caroline Wright of the Foundation for Genomics and Population Health (a charitable company registered in England and Wales) …

“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug (see previous news article), the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.

Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.

The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.

FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicine”

Remember – PDUFA page 182. Working together we can accomplish great things for the public health.  Read More & Comment...

Fearmongering on SSRIs as a PR Tool

09/24/2007 12:43 PM |

Alison Bass (a former Boston Globe reporter with a long hate the industry bias) is the latest apologist for the increase in suicides as a result of the fearmongering over SSRIs. In an editorial called "Suicide Rates as a PR Tool" she attributes better mental health care and gun control (!) Really? So how are kids killing themselves now in the wake of better mental health care and stricter gun controls if SSRIs have nothing to do with it. The idiocy of zealot courtesy of another anti-medication fanatic, Univ of Maryland researcher Julie Zito.

Oh, Bass is the author of a forthcoming book entitled, "Side Effects: A Best-selling Drug on Trial." How about fearmongering and demeaning those who have struggled to combat suicide as a PR tool. Where does a suicide denier stack up next to a Holocaust denier.

http://www.boston.com/news/globe/editorial_opinion/



Others like Alex (I stole the documents) Berenson dismiss the number of suicides as so small as to really merit concern. Funny, when Steve (I want to cause people's hands to tremble a little bit before they write that prescription," )Nissen and Curt Furberg were foaming at the mouth about 25 'unexplained' heart attacks among kids taking ADHD drugs over a ten year period that was enough to demand a black box an entire class of drugs and for the NY Times to run story after story validating as opposed to questioning the concerns.

http://www.nytimes.com/2006/02/10/health/policy/10drug.html

http://www.nytimes.com/2006/02/21/health/21psyc.html?fta=y

Keep it coming. Every time these whack jobs and their apologists take a run at the work of Robert Gibbons -- which has been verified by Greg Simon at Group of Health Puget Sound and J. John Mann and many others -- the most extreme and dangerous they appear.  Read More & Comment...

Page 182

09/24/2007 11:34 AM |

In PDUFA, that is. Page 182. That's where the language creating the Reagan/Udall Foundation begins. And if you want to talk about real FDA reform -- its really the most important part of the whole package.

But what's been written about it can be summed up in two words -- almost nothing.

All the more reason to watch this space.  Read More & Comment...

My Take On Hillarycare

09/24/2007 09:53 AM |

The new Hillarycare  Read More & Comment...

SG as ASG

09/24/2007 07:29 AM |

Steve Galson is a man of honor, integrity, passion, and intelligence -- and he's a terrific choice for Acting U.S. Surgeon General.  Read More & Comment...

Yom Kippur

09/21/2007 08:15 AM |

Drugwonks will be closed and will not be updated until after Yom Kippur is over.. We leave you with a story that reflects the essence of Rabbi Israel Salanter, a leader of the Mussar (Orthodox Jewish values and ethics) movement in Vilna..

Two unforeseen developments rocked Reb Yisroel's stay in Vilna. The first was related to Reb Yisroel's attitude toward matters of health. He accepted doctor's orders as halachah (Torah law), implicit in the command of ''V'Nishmarsem M'od L'Nafshoseihem", "And you shall guard your lives" (Devarim 4:15). When health concerns conflicted with other halachos, he usually decided with a consistent leniency as far as the latter was concerned. He seemed to share Reb Chaim Brisker's view: "I am not lenient in regard to Shabbos or Yom Kippur; rather I am stringent in the laws of preservation of life!"15

Since Reb Yisroel never rendered any halachic decisions in Vilna, not even for his own household,16 he must have experienced enormous personal conflict during the peak of a cholera epidemic that devastated Vilna in late summer 1848. Reb Yisroel had committed himself to the city's welfare - renting hospital quarters with five hundred beds, while his own talmidim nursed the stricken around the clock, seven days a week, with patient care on Shabbos no different than on the other days of the week. As Yom Kippur approached, he feared that the fast would weaken the people and make them dangerously susceptible to the often-fatal disease. Reb Yisroel hung placards throughout Vilna urging all who felt weak to eat on the fast day, to stave off any threat. He did this without consulting others because he apparently realized that he would not gain a consensus for such a radical, yet - in his view - essential move. Immediately after Shacharis on Yom Kippur, he himself rose to the bimah, and according to some accounts, publicly made Kiddush and ate some cakes to encourage all those in need to follow suit. Needless to say, there were great protests, but Reb Yisroel ignored them and reportedly made his way to other shuls as well, to urge others to join him.

We join with others in wishing everyone "gmar khasime tova" ... That everyone should be enscribed for a good year.  Read More & Comment...

Sirtris and Harvard Discover New Mechanism to Slow Aging: CMS Optimal Dose Soon To Follow

09/20/2007 12:45 PM |

We don't want people living too long now, do we? Not cost-effective. Thank goodness we have the know it alls at CMS who can quickly come up with the optimal lifespan. Once you have the optimal dose for ESAs down pat why stop there? Something for Herb Kuhn and co to think about as they defend their decision and peddle their brilliance to congressional staff in the weeks ahead....

http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20070920005089&newsLang=en  Read More & Comment...

Pelosi Pays Off the Trial Bar...Introduces Nissen-Furberg FDA Premption Amendment to PDUFDA Reup

09/20/2007 10:59 AM |

As Scott Gottlieb's piece in the WSJ demonstrates, FDA reform is now all about legal pork, not public health. But what Scott didn't note is how our good friends Nissen and Furberg have played and will play a pivotal role in greasing this greed machine.

It all comes together.

The Dems -- under orders from Nancy Pelosi -- have inserted a legal loophole into the FDA reform bill that would give trial lawyers the right to sue drug companies if they don't provide additional information about the risks of drugs independent of what the FDA tells them to provide to the public. This is way to undermine the sole authority -- upheld by courts -- to determine if a drug is safe and effect. It is part of this general trend toward drug safety vigilantism which is being aided and abetted by free lancers inside and outside the FDA who leak and release hastily produced studies to Congress and to the media -- before and after duly constituted FDA review periods.

This shameful assault on the public health is fueled and funded by the trial bar who have pressured and paid for Democrats to slip this last minute provision into a bill that is required to keep the FDA operating.

Now where in the world will the trial bar get the evidence that a drug is unsafe independent of FDA decisions.

Enter Nissen, Furberg, Graham, Avorn, et. al who with the help of the nutroots on the internet (some whom are funded by the trial bar) stoke fear and provide story ideas for the media and copy for an eternally bent over medical journal establishment that is willing to receive what ever they deliver about how dangerous drugs are. No surprise that the "studies" of Furberg -- the 'unpaid' advisor to the trial bar figure prominently in the argument for what the Dems are calling a rule of construction that would allow lawyers to sue companies for not including warnings (based on studies generated by people like Nissen and Furberg) even when the FDA prohibits a company from including warnings without it's consent. The FDA does not engage -- with the exception of a handful of cranks -- in fearmongering. Guys like Nissen do it because it increases their power. And Trial Lawyer Inc. has allied with them because their fearmongering fertilizes the ground from which they reap profits.

The result? Fewer new drugs, fewer new uses, less innovation and less medical benefit.


http://online.wsj.com/article/SB119025325354433415.html?mod=opinion_main_commentaries  Read More & Comment...

On the Mark

09/20/2007 09:16 AM |

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.  Read More & Comment...

On the Money

09/20/2007 07:07 AM |

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.  Read More & Comment...

Disclosure Cuts Both Ways Senator Dorgan

09/19/2007 11:13 PM |

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.  Read More & Comment...