For the second time in as many months, the Centers for Medicare & Medicaid Services is being sued by an organization that has deep suspicions about the reason the agency chose to conduct a so-called National Coverage Analysis of the controversial Provenge prostate cancer vaccine, which was approved last spring by the FDA.
This time around, Judicial Watch is demanding that CMS hand over documents that the organization believes will shed light on the review process, which the organization contends may have been undertaken in an effort to begin rationing healthcare. In explaining the reason for filing its lawsuit, Judicial Watch maintains that "cost is the major factor in the unusual decision by CMS" (read the statement). The Dendreon vaccine costs $93,000 per patient, although some analysts say the price tag may be no costlier than treating some patients with chemotherapy.
The lawsuit comes two months after a CMS advisory panel voted that Dendreon’s Provenge shows “clinically significant” improvement in survival as part of the NCA process, which was triggered by questions raised by Medicare contractors amid concerns over off-label use. Such a meeting is unusual, though, given that Medicare generally pays automatically for FDA-approved oncology meds (read what one former CMS official had to say here).
Provenge was approved based on a study showing a four-month survival benefit and most patients who qualify for Provenge treatment also qualify for Medicare. However, the outcome of the recent advisory panel meeting is not the final word. CMS will not issue a coverage proposal until March and a final decision is not expected until June.
Last month, an activist patient and investor group called Care To Live filed a similar lawsuit because, like Judicial Watch, its efforts to obtain documents were rebuffed (read this). The group has argued government bureaucrats conspired with financially conflicted cancer specialists and behind-the-scenes investors in rival treatments to continually delay Provenge from becoming available.
Meanwhile, RW Baird analyst Chris Raymond issued an investor note this morning that physician awareness of Provenge is rising - 90 percent of oncologists, up from 84 percent in August and 47 percent in May. Also, he writes that, despite limited availability, twice as many oncologists in his survey (16 out of 90) have treated a patient with Provenge versus eight out of 84 in August. And the average number of patients treated was five, up from just one.
He adds that four out of four physicians say they were reimbursed for Provenge, up from 67 percent last summer. Obviously, he is dealing with small sample sizes, but he pointed out the insurers include such big names as Aetna and Blue Cross/Blue Shield and Medicare. Finally, he writes that 69 percent of docs expect to prescribe Provenge, compared with 59 percent last August.
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So much for Honesty in Government:
THE WHITE HOUSE Office of the Press Secretary
For Immediate Release January 21, 2009
January 21, 2009
MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES SUBJECT: Freedom of Information Act
A democracy requires accountability, and accountability requires transparency. As Justice Louis Brandeis wrote, "sunlight is said to be the best of disinfectants." In our democracy, the Freedom of Information Act (FOIA), which encourages accountability through transparency, is the most prominent expression of a profound national commitment to ensuring an open Government. At the heart of that commitment is the idea that accountability is in the interest of the Government and the citizenry alike.
The Freedom of Information Act should be administered with a clear presumption: In the face of doubt, openness prevails. The Government should not keep information confidential merely because public officials might be embarrassed by disclosure, because errors and failures might be revealed, or because of speculative or abstract fears. Nondisclosure should never be based on an effort to protect the personal interests of Government officials at the expense of those they are supposed to serve. In responding to requests under the FOIA, executive branch agencies (agencies) should act promptly and in a spirit of cooperation, recognizing that such agencies are servants of the public.
All agencies should adopt a presumption in favor of disclosure, in order to renew their commitment to the principles embodied in FOIA, and to usher in a new era of open Government. The presumption of disclosure should be applied to all decisions involving FOIA.
The presumption of disclosure also means that agencies should take affirmative steps to make information public. They should not wait for specific requests from the public. All agencies should use modern technology to inform citizens about what is known and done by their Government. Disclosure should be timely.
I direct the Attorney General to issue new guidelines governing the FOIA to the heads of executive departments and agencies, reaffirming the commitment to accountability and transparency, and to publish such guidelines in the Federal Register. In doing so, the Attorney General should review FOIA reports produced by the agencies under Executive Order 13392 of December 14, 2005. I also direct the Director of the Office of Management and Budget to update guidance to the agencies to increase and improve information dissemination to the public, including through the use of new technologies, and to publish such guidance in the Federal Register.
This memorandum does not create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
The Director of the Office of Management and Budget is hereby authorized and directed to publish this memorandum in the Federal Register.
BARACK OBAMA
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based on their mission statement, judicial watch should really be suing caretolive rather than medicare, but it sounds like dendreon got to them first :)
Finally Dendreon decided to restore its image, and recruited a proper activist group who accepts donations that are tax-deductible. ... None of these changes the fact that Provenge does not work, however.
dendreon management (mitch gold & co), advisors (phil kantoff & jim gulley), lobbyist (glover park group & judicial watch) and investors (caretolive) should all volunteer to receive provenge if they truly believe it is safe and efficaceous (it would prevent their future prostate cancers without harming them, if it works like they say, right?). overall, if they did this, i think that would solve a lot of problems in the world today.
rorschach...bring it on! I'd be the first in line if I was diagnosed with PCa.
Pardon my biochemistry, but how can you generate an autologous vaccine for a condition you don't have yet? The condition of possibility is absent unless your argument is that all males actually have prostate cancer but 'don't know it yet?'
Take a deep breath, rorschach, you are hyperventialing on this one.
PS - Personal question - are you realy as striking a figure as you were in "Watchmen?"
well, provenge doesn't really work, so it shouldn't really matter :)
ps. i do pardon your biochemistry. provenge is not a vaccine but immunotherapy. the "autologous" part is cellular not antigenic. the antigen used to activate patient-derived cells is not in itself patient-derived or patient-specific (pap-gmcsf). so the stage of administration of provenge shouldn't matter (whether metastatic PCa, pre-metastatic PCa, or pre-PCa). in fact dendreon itself is trying to expand the label to early stage disease. so i guess they would pardon your biochemistry too.
Dendreon tried to recruit Glen Beck, but he was too expensive, so they went with Tom Fitton of Judicial Watch. ... May I also suggest Ann Coulter and Rush Limbaugh for the next wave of Provenge lobbying?
Christopher Chance's immuno-depletion hypothesis turned out to be a comic book assertion.
And, rorschach's reasoning is about as revealing as an inkblot.
Guys - Thanks for the laugh and good luck tomorrow!
rorsschach:
Thanks for your pardon "Governor" - and I apologize for the slip. The word should have been "treatment." My mind wandered back over 15 years to the description used by ANTIGENICS - "personalized cancer vaccine." They are both autologous but not the same. 'Primacy - Recency' took over.
That said, there is a difference between 'early' and 'non-existent.' And, unfortunately, given their involvement, none of the persons named would be able to qualify for a rigorous clinical trial due to their relationship with the company - IMHO.
ahhh chrissy and rorschach are quite the tandem! i bet your short hurt on friday.
It appears that some are using the same political plot to salvage the failed product. The CMS vote results indicated sub-substantial evidence used in support of the approval. What a shame! The federal regulations state clearly that substantial evidence is required for FDA approval. A mistake was made, but the destruction to patients should be stopped in the spirit of being honest and caring of those suffering from the disease. Further effectiveness evidence is apparently needed for this product.
Real scientific findings are not afraid of being examined further and should be reproduciable for the sake of patients and taxpayer money. But some are scared of CMS reexamination of its "efficacy" and shout off any idea of doing further investigation. Why? Simply, they want the modern, wolf-with-sheep-clothing scam continued to cheat patients and scientificlly lazy practioners and so to make more dark-hearted money.