Diagnostics & Imaging Week Washington Editor

Former senator Tom Daschle announced yesterday that he is withdrawing his name from consideration for the post of the Secretary of Health and Human Services. Daschle's announcement comes at an especially sensitive time, given the urgency on the part of the Democratic Party to reshape healthcare in short order.

Daschle's announcement came almost simultaneously with an announcement by another Obama nominee, Nancy Killefer, who was tagged to serve as the administration's chief performance officer, a new post in the executive branch. Killefer failed to pay taxes for household help, and the District of Columbia placed a lien on her home in 2005 over unemployment compensation taxes, which are said to have come to roughly $950.

Daschle's tax liabilities loomed much larger. The former Senate majority leader last week paid back taxes and associated interest of more than $140,000 in connection with limousine services he used for three years at no charge. However, Senate Republicans also questioned his ties to the insurance industry, citing numerous speaking fees and other financial ties, especially given President Obama's promise to staff a cabinet that is free of special interests. However, Daschle's purported seven-figure salary for entities such as the law firm of Alston & Bird (Washington) also tore away at some of the support he might have enjoyed.

Senate Finance Committee chairman Max Baucus (D-Montana), who earlier in the day had addressed a healthcare policy gathering in Washington, said in a statement released yesterday afternoon, "it was with regret but with respect for his decision that I learned of Senator Daschle's request to withdraw his name from consideration for Secretary of Health and Human Services." Baucus noted that Daschle "would have been a terrific partner at HHS on health reform, and I hope and fully expect that he will continue to play a leading and valuable role in health policy for this country."

Baucus made no mention of the development yesterday morning, and his office had published the previous day an announcement that the Finance Committee would take up the nomination in a Feb. 10 hearing.

The committee's ranking member, Chuck Grassley (R-Iowa), had a less amicable view of the nominee's problems, and his comments may foreshadow an early end to the bipartisan comity the Obama administration hoped to develop. According to wire service reports, Grassley said, "I don't know whether I'm finding so much fault with people like Daschle and Geithner as I am with a president that wanted to get his administration up and running, bragged about the vetting process, bragged about not having ethics problems and conflicts of interest, but just look at the stumbles that have been made."

The bipartisan feeling was also not abetted by the fact that no Republicans and 11 Democrats voted against the House's version of the economic stimulus bill, which the Senate is currently considering.

Sen. Dick Durbin (D-Illinois), noted that the development "really sets us back a step," given that the former South Dakota senator "understood Congress" because he served in both chambers, and because ""he certainly had the confidence of the president."

In a written statement, Obama said, "now we must move forward with sadness and regret," but Daschle denied any pressure from the White House.

White House promises FDA pick

The Obama administration is promising to announce its selection to take over the commissioner's post at FDA in the coming days, but the White House is still playing it's hand closely.

According to wire service reports, Robert Gibbs, White House spokesman, told reporters at a press conference that Obama "hopes in the next few days to announce a pick for commissioner at FDA." Gibbs made the comments in the shadow of the salmonella-tainted peanut butter outbreak, noting that "whether it was our own regulatory system or a company that repeatedly found salmonella in its own testing (and) would continue to ship out that product is beyond disturbing for millions of parents."

However, any nominee will likely have to wait until Daschle's back-tax embarrassment clears the Senate, a process whose end is not yet in sight.

Among the now-expanded list of potential commissioners are Joshua Sharfstein, MD, who runs the public health department for the city of Baltimore and Robert Califf, MD, a cardiologist at Duke University Medical Center (Durham, North Carolina). However, cardiologist Steve Nissen of the Cleveland Clinic (Cleveland) apparently also is still in the running.

Frank Torti, MD, is currently serving as the interim commissioner at FDA. Torti was named the agency's chief science officer last April.

Obama wants 'complete review' of FDA

President Barack Obama is said to have ordered a "complete review" of operations at FDA as a result of the distribution of salmonella-contaminated peanut products that have sickened more than 500 people and may involved in eight deaths in an interview aired Sunday on the Today Show.

According to wire service reports, Obama told Matt Lauer, co-host of the Today Show, that the agency's failure to recognize and intercept the products was only one of numerous "instances over the last several years" in which the agency "has not been able to catch some of these things as quickly as I expect them to catch."

Obama told Lauer in the interview, which was recorded Sunday at the White House, that at a minimum, American citizens should "be able to count on our government keeping our kids safe when they eat peanut butter."

Proton beams for prostate cancer still stuck in limbo

The Centers for Medicare & Medicaid Services has to cope with the impact of new technology on medical treatment, but sometimes some old-timer technologies resurface as reimbursement issues. This is the decidedly the case where proton beam therapy (PBT) is concerned, especially in connection with a proposal last year to examine the possibility of covering PBT treatment of prostate cancer. However, the situation is unresolved and the change of administration seems to offer little prospect of action anytime soon

One opponent of such an expansion of coverage is Mark Thompson, MD, of the Florida Radiation Oncology Group (Orange Park, Florida), who wrote in an Aug. 8, 2008 letter to CMS that "the results in treating prostate cancer are no better than using IMRT (intensity-modulated radiation therapy from an X-ray source) or prostate brachytherapy, which cost a fraction of proton therapy." Thompson made the case that until the data for PBT "support superior results ... protons for prostate cancer should not be funded."

Taking a different tack is Leonard Artz, executive director of the National Association for Proton Therapy (NASP; Silver Spring, Maryland), who faxed to Diagnostics & Imaging Week a copy of the Sept. 26, 2008 letter he sent to CMS on the matter. Artz wrote that "authoritative evidence does exist demonstrating that the benefits ... far outweigh any anticipated risks" thanks to the therapy's "greater precision" in terms of dosing area.

Artz's position is backed by a Sept. 25, 2008, letter to CMS from Ruthita Fike, CEO of the Loma Linda University Medical Center (Loma Linda, California), which states that "PBT can be distinguished from IMRT based on both the volume of normal tissue treated ... and the amount of radiation exposure to normal tissue," adding that increased exposure from IMRT "can lead to a second malignancy or unwanted side effects to the normal tissue, which make take years, perhaps decades, to develop."

A third position was offered by the American Society for Radiation Oncology (ASTRO; Fairfax, Virginia), whose Sept. 25, 2008, letter, e-mailed to D&IW, recommended "that the coverage with study participation policy be applied" to a "comparative registry study (possibly with a parallel randomized clinical trial arm)," which "is likely to provide meaningful answers" on the safety and efficacy of PBT in this use."

Neither ASTRO nor NASP would comment for the record.

FDA guidance on enterovirus assays

FDA released a guidance on for class II controls for assays that use nucleic acid amplification for detection of the enterovirus, ratcheting down the requirement for this class of diagnostic from a class III device. However, the guidance addresses only such tests when using samples from the patient's cerebrospinal fluid, and sponsors will have to conduct clinical trials in at least three sites that are "representative of where you intend to market the device."

According to the accompanying announcement in the Jan. 2 edition of the Federal Register, diagnostics maker Cepheid (Sunnyvale, California) "submitted a petition dated March 9, 2007," requesting the reclassification in reference to the company's Xpert EV system.

The guidance states that sponsors will still have to demonstrate that their assay "can detect all serotypes (currently 64 serotypes) that have been associated with aseptic meningitis," a list that includes coxsackievirus in addition to enterovirus. FDA states also that the guidance does not apply to assays testing for enterovirus in asymptomatic individuals, noting that such an intended use would require study designs that deal with a screening function.

With regard to reagents employed in an applicant's assay, the agency states that it is working on a "draft guidance regarding nucleic acid amplification testing, which will be particularly relevant when it is finalized." As for external controls, sponsors will have to employ them "every day of testing for the duration of the analytical and clinical studies."

In order to establish the precision of the assay, sponsors are expected to "test sources of variability (such as operators, days, assay runs) for a minimum of 12 days (not necessarily consecutive) with two operators each performing two runs per day and two replicates of each sample per run."

As for the trials, FDA recommends "prospective clinical studies" that may use archived samples from patients "from whom fresh specimens may not be readily available." The trial should be designed to generate a "90% sensitivity with a lower-bound of the two-sided 95% confidence interval greater than 80%." FDA is not opposed to outside-U.S. data as indicated by the statement "at least one of the study sites should be a U.S. site." Also, one of those sites "may be in-house."

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