Flap's Blog – FullosseousFlap's Dental Blog

The Wine Bet looks even better now:

Bush Poised to Nominate Dozens For Judgeships, GOP Insiders Say

The White House is preparing to send a raft of new judicial nominations to the Senate in the next few weeks, according to Republican strategists inside and outside the administration — a move that could challenge the durability of last week’s bipartisan filibuster deal and reignite the political warfare it was intended to halt.

The Bush administration has been vetting candidates for 30 more federal district and appeals court vacancies that have been left open for months while the Senate battled over previous nominations stalled by Democrats. Now that Democrats have agreed not to filibuster any new candidates except in “extraordinary circumstances,” Republicans are eager to test the proposition.

Great and test the resolve of the Gang of 7.

Will they support their President and Party?

Republicans feel this is a good moment to move forward with judicial nominations,” said Sean Rushton, executive director of the Committee for Justice, a group formed by C. Boyden Gray, who was White House counsel under President Bush’s father, to support the current president’s judicial appointments. “It’s time to move on and also to get past the Clinton period” when Democrats salted the federal judiciary with more liberal appointments.

Rushton said he expects “a large swath” of nominations in the next few weeks unless Chief Justice William H. Rehnquist or another Supreme Court justice decides to step down at the end of the term later this month, an event that would throw current plans out the window. Administration and congressional officials, who spoke on the condition of anonymity because no announcement has been made, said they, too, expect a flurry of lower-court nominations within weeks. “There’s about 20 waiting in the wings,” a Senate Republican official said.

Flap handicaps two Supreme Court vacancies at the end of the term (end of June), so this flurry of nominations may be postponed.

Democrats called on Bush to abide by the Senate agreement’s provision, urging him “to consult with members of the Senate, both Democratic and Republican, prior to submitting a judicial nomination to the Senate for consideration.”

“We do consult,” Bush said at his news conference this week. “Obviously, we consult on district judges and . . . we listen to their opinions on appellate judges — ‘their’ opinions being the opinions from the home state senators, as well as others.”

Yet Bush found the deal sufficiently hazy that he could not predict its effect. “Whether that agreement means that a [nominee] is going to get an up-or-down vote, I guess it was vague enough for people to interpret the agreement the way they want to interpret it,” he said. “I’ll put a best face on it, and that is that since they’re moving forward with Judge Owen, for example, and others, that ‘extraordinary circumstances’ means just that — really extraordinary.”

He paused. “I don’t know what that means,” he said to laughter. “I guess we’re about to find out when it comes to other appellate judges.”

And find out we will.

Paul, the Firstone winery is located in the Santa Ynez Valley, California

It looks like Flap, Patterico and Xrlq will win their wine bet:

This is what Flap wants Paul.

and Why?

It appears that former Interior Department Solicitor General William Myer’s nomination to the 9th Circuit Court of Appeals will be filibustered by Senate Democrats:

In that now-famous, or perhaps infamous, compromise deal by 14 U.S. senators hoping to end a quarrel over judicial filibusters, the name of former Interior Department Solicitor General William Myers (search) was excluded from an agreement not to filibuster.

For months, Republicans claimed to have the votes to confirm Myers to the 9th Circuit Court of Appeals were it not for democratic filibusters. But now he remains in judicial limbo. Detractors say it is because he lacks the necessary Washington gravitas. The American Bar Association rated him “qualified,” but supporters say that’s too lukewarm.

Two-thirds of the judges on the 9th Circuit were appointed by Democratic presidents, one-third by Republicans. GOP sources in the Senate confirm they plan to call for a vote on Myers sometime this month.

Democrats are expected to filibuster, and key senators in that compromise deal confirm that a filibuster of Myers will not trigger the “nuclear” or “constitutional” option, meaning the nominee may not get an up-or-down vote.

But, this is not the first time nor the first nominee that has had their nomination blocked by Senate Democrats.

Tuesday, July 20, 2004

Senate Democrats on Tuesday blocked a former Interior Department official who once worked for mining and cattle interests from becoming a federal appeals judge, using the debate to criticize President Bush’s environmental record.

The Senate’s majority Republicans were unable to muster the 60 votes needed for the confirmation of William Myers for the San Francisco-based 9th U.S. Circuit Court of Appeals. The final vote was 53-44, making Myers the seventh Bush judicial nominee to be stopped by Senate Democrats.

So, when will Bill Frist call him up?

Will the Gang of 7 (McCain, DeWine, Snowe, Warner, Graham, Collins Chafee who is not present) let him be blocked by filibuster? Or….

Will Frist and the President show some guts, enforce party discipline and invoke a change of Senate rules – THE NUCLEAR OPTION?

Why did the Democrats ever choose Dr. Dean as their national chairman?

Look, what he said today:

Howard Dean, appearing before the Take Back America convention, denounced the idea of having to stand in line 8 hours to cast a vote. Agreed. He then continued:

“Republicans, I guess, can do that ’cause there are a lot of them that have never made an honest living in their lives.”

What a moron!

President Bush criticized Senate Democrats on Tuesday for “stalling” a vote on John R. Bolton’s nomination as ambassador to the United Nations, and indicated that he would not grant them access to intelligence documents they have demanded to see before allowing the confirmation to go ahead.

Mr. Bush’s statements, at a news conference in the Rose Garden, suggested that he was intent on winning the battle over Mr. Bolton on his own terms when the Senate reconvenes next week, rather than negotiating a deal with Democrats and some Republicans who have been advocating a compromise.

And why should he bother?

The Lefties like Biden and Boxer will vote against Bolton in any case.

The Senate has stalled long enough – the Senate Democrats must either filibuster him or give him an up or down vote.

Move on!

Confirm Them has the poop on the William Rehnquist, Chief Justice of the Unites States Supreme Court stepping down here:

I don’t think this news will come as a surprise to anyone, but I just received a phone call from an extremely reliable source who tells me that it’s a done deal.

My prediction: President Bush will tap Judge Michael W. McConnell of the U.S. Court of Appeals for the 10th Circuit to fill the Rehnquist vacancy and to be the next Chief.

Flap’s short list is here:

A short list of possible Bush nominees to the United States Supreme Court is being reported in the Washington Times here:

Judge Michael W. McConnell on the 10th U.S. Circuit Court of Appeals

Judge Edith Hollan Jones, who practiced law in Texas and now sits on the 5th U.S. Circuit Court of Appeals in New Orleans.

Samuel Alito, a 3rd U.S. Circuit judge from Philadelphia.

J. Michael Luttig of the 4th Circuit Court of Appeals, considered one of the most conservative judges on the federal bench.

J. Harvie Wilkinson III, also on the 4th Circuit, who is considered more moderate than Judge Luttig but could be opposed by liberals over his opposition of affirmative action.

Emilio Garza of the 5th Circuit, who would give Mr. Bush the chance to name the first Hispanic justice, but whose conservative views on abortion could prompt liberal outcry.

Flap’s bet is for at least two appointments this summer to replace Chief Justice Rehnquist and Justice Sandra Day O’Connor.

Flap’s handicap for Chief Justice is Antonin Scalia.

Update #1

SCOTUS Blog has this take on the possible nomination of Apeals Court Judge Michael McConnell to Unites States Supreme Court:

Tony Mauro has this article (via How Appealing) on the increasing prominence of Judge McConnell in discussions of prospective Supreme Court nominees.

Two things about the article struck me. First, the suggestion of “detractors” that McConnell moved to Utah to further “his judicial aspirations” by becoming “a constituent of powerful Sen. Orrin Hatch, R-Utah” seems absurd to the point of hilarity. Others know the Judge much better than I do, but those who do know him think of him as among the least manipulative and calculating people you could meet.

Second, the article quotes Jay Sekulow not only as strongly favoring Judge McConnell’s nomination but also heartily endorsing John Roberts. The former is not at all surprising — given Judge McConnell’s views on Roe and church-state relations — but the latter may be quite signficant, given that Judge Roberts’s short track-record on abortion and religion might otherwise have been thought to give religious conservatives pause. In that community, you cannot have a more prominent champion than Jay Sekulow.

Flap is reposting this alert for dentists and physicians. Initially, this warning was posted some months ago here.

A May 18, 2005 advisory from MedWatch: Zometa (zoledronic acid) & Aredia (pamidronate dis odium) Associated with Osteonecrosis of Jaw is found here:

May 18, 2005–Novartis and FDA notified dental healthcare professionals of revisions to the prescribing information to describe the occurence of osteonecrosis of the jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia (pamidronate disodium) and Zometa (zoledronic acid). The prescribing information recommends that cancer patients receive a dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa), and avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition.

Read the Novartis Dear Healthcare Professional letter below. The and revised labels for Zometa and Aredia are attached.

Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936

IMPORTANT DRUG PRECAUTION FOR DENTAL HEALTH PROFESSIONALS WITH PATIENTS BEING TREATED FOR CANCER

(second copy for other dental health professionals in your practice)

May 05, 2005

Dear Doctor:

We are writing to inform you of an adverse event Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia and Zometa, which may have an impact on the dental care of patients within your practice. While on treatment, invasive dental procedures should be avoided, if possible.

The prescribing information recommends that cancer patients:

1. • receive a dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa); and
2. • avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. Clinical judgment by the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

Aredia is used in the treatment of hypercalcemia of malignancy, Paget’s disease, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. Zometa is used in the treatment of hypercalcemia of malignancy, the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.

In the U.S. Package Insert for both Aredia and Zometa, the following information on osteonecrosis of the jaw has been added under the Precautions Section.

Precautions

Osteonecrosis of the jaw

Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

ONJ is a complex problem with multiple risk factors. Typical signs and symptoms of ONJ include, but are not limited to: pain, swelling, or infection of the gums; loosening of the teeth; poor healing of the gums; numbness or a feeling of heaviness in the jaw; drainage and exposed bone. The seriousness of ONJ ranges from patient being asymptomatic to requiring sections of the jaw to be removed.

Dentists, oral surgeons, periodontists, prosthodontists, dental hygienists, and other dental health professionals can play a vital role in identifying ONJ and other oral complications of cancer and cancer therapy.

For more information about dental treatment for cancer patients receiving bisphosphonate therapy, please refer to the enclosed:

1. • “Expert Panel Recommendations for the Prevention, Diagnosis and Treatment of Osteonecrosis of the Jaws: June 2004″
2. • Revised package inserts on complete prescribing information for both Aredia and Zometa
3. • Patient brochure, “Taking Care of Yourself While Living With Cancer: Dental Health and Osteonecrosis of the Jaw,” which you can share with patients who request more information on the topic (ONC-8155-01)
4. • Copy of this letter, which we ask you to share with other dental health professionals in your practice, including dental hygienists

Additional copies of the patient brochure are available at no charge by calling Novartis at [1-800-521-9445] using the order number provided above.

Healthcare professionals are strongly encouraged to submit a report of any serious adverse events that occur with the use of Aredia or Zometa to Novartis Pharmaceuticals Corporation at [1-800-882-6577] or fax [1-888-299-4565] or to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm ] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Please contact Novartis Oncology Medical Services at [1-888-669-6682] if you have questions.

Sincerely,

John A. Hohneker, MD Alan L. Bess, M.D.

VP, Novartis Oncology Medical Affairs & Services VP, Clinical Safety & Epidemiology One Health Plaza One Health Plaza East Hanover, NJ 07936 East Hanover, NJ 07936

Contacting MedWatch

U.S. Food and Drug Administration
MedWatch Office, 5600 Fishers Lane, HFD-410
Rockville, MD 20857
Fax: 301-827-7241

Downloads
20036s030lbl.pdf
Zometa_PI_nov2004.pdf

Flap will report with additional advisories as they become available.