After a two-year investigation into disclosure issues surrounding a top University of Minnesota physician faculty member, the case is now closed — accompanied by a stern “cautionary letter” which
instructed him to take corrective measures to prevent further problems, but decided against further disciplinary action. A review committee found no evidence of fraud or misrepresentation. However, the committee found that Polly failed to sufficiently disclose the Medtronic relationship in connection with two medical journal publications and a conference presentation.
He no longer does work which requires scrutiny for disclosure since the investigation’s launch in November 2009. | LINK
It’s got bipartisan support, and it would call for transparency the amount that Medicare pays providers for treating patients.[1] Sens. Wyden (D-MA) and Grassley (R-IA) are introducing the Medicare Data Access for Transparency and Accountability Act . Its passage into law would override an existing 1979 proviso that keeps such numbers confidential. The original intention of such a law is out of step with the tenets of reform and the new bill’s introduction is a welcome sight in the race to combat Medicare fraud. It is interesting to note that the current injunction has languished for over thirty years — its origins resulting from the obligations of a Florida district court on behalf of the AMA and that state’s medical association to keep such data secret.
The AMA still has that position, arguing that release of providers’ Medicare billing info violates privacy in this area and amounts to a form of identity theft. A pretty weak argument when one considers the reason for transparency in this situation: last year the WSJ ran a series of articles highlighting physicians receiving payments in the millions for running unnecessary testing, surgeries, and procedures on Medicare beneficiaries based upon access to limited Medicare claims data. | Sen. Grassley’s statement here | LINK 2
The Senate passed unanimously the Physician Payment and Therapy Relief Act of 2010 (summary here [PDF]), which will extend the period forgoing cuts to Medicare physician reimbursements for another month.[1] The 23 percent reductions in those reimbursements was to go into effect on 12/1. Although the vote was expected in this lame duck session of Congress, the move marks a step in the right direction as lawmakers — particularly those on the powerful Senate Finance Cmte. — see the value in maintaining Medicare solvency over the next decade.
The so-called successive “doc fixes”, as these iterations have been called, appear to be setting the stage for modifying the SGR formula upon which such reimbursements are based. Several lobbies, among them the AMA, have been vociferous in their attempts to get Congress to act on legislation which would, at the very least, guarantee adequate reimbursements until the end of 2012.
As a product of the Bush II administration, the Medicare Modernization Act (2003) allowed managed care plans to contract with Medicare to offer alternatives to beneficiaries in a healthcare marketplace radically different than what exists now. Meant as another mode of entry of third parties into the care of the elderly while emphasizing preventive care, Medicare Advantage — as it was dubbed — opened the floodgates of myriad options, pricing, and coverage schemes to beneficiaries and employers alike under the banner of quality that was superior to traditional Medicare fee for service.
It didn’t take long for the abuses to occur on the side of the payer to Medicare, however, as bad marketing practices and sales of these plans became increasingly prevalent in a relatively short time — allowing yet another target of healthcare reform that justified correction by the Obama administration. Unsurprisingly, Republicans countered that reform of MA plans was tantamount to threatening Medicare for all seniors; they have vowed to consider everything from lawsuits to repeal of the reform law — a strategy that could be serving them well on the eve of the midterm elections. Arguing that Democrats’ push for cuts to many MA plans under reform are ultimately hurting seniors’ right to quality delivery, four senate GOPers are now asking for a re-examination of proposed cuts based upon the release of a CMS actuarial report that apparently backs up the party’s claims. | LINK
The vote is 20-12 against withdrawing GSK’s troubled drug Avandia from the marketplace. Essentially, the FDA says that — in spite of the earlier vote the committee had on positively acknowledging the cardiac risks associated with the drug — those risks were not deemed strong enough to warrant removal. Twelve of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven wanted to add stiffer language to the current label, and 10 wanted both stiffer language and restrictions on its use.
What is known now is that, according to the FDA, unless there is more long-term data on a link between Avandia’s use and cardiovascular death, there is nothing in terms of evidence currently convincing enough to warrant pulling the drug from the market. That’s the official statement by the agency, anyway.
As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably say a lot about the process that leads to it. The latest salvos from Day 1?
An FDA scientist, speaking of GSK’s studies of the drug minimizing risk: You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.
GSK’s VP of Clinical Development: Our studies provide the most robust and reliable data to assess Avandia’s safety, and those studies have found no evidence to suggest the drug increases the risk of heart attack or stroke in its users.
Testimony continues today with a decision expected on whether to pull the drug or apply restrictions to its use.
GSK (then known as SmithKline Beecham) knew in a 1999 trial that Avandia, the drug undergoing scrutiny on its fate in the pharma marketplace today, posed a signficant cardiac risk when compared to its major competitor Actos — and it purposefully covered up that information. This, according to a report obtained by the NYT.
The reports … say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart.
GSK has always stuck to its guns in defending its assertions that statements like that are based upon faulty safety information gleaned from major trials casting the drug in a negative light — like the well-known RECORD trial, which found that the overall risk of cardiovascular death of Avandia was not statistically significant. That meta-analysis was commissioned by GSK at the request of the FDA.
This is just the latest revelation in a very public battle over a Pharma company’s credibility in the healthcare marketplace and the validity of new information from a Senate investigation into that company’s handling of the trial results. Implications on who controls subsequent drug safety and treatment data years after a drug’s initial availability and what it means for the welfare of the public taking the drug versus pharma profits from the sale of the drug should be weighing greatly on the FDA panel making the decision on the drug’s ultimate fate. | LINK
It’s official. The FDA will convene this Tuesday (13) to discuss and come to a decision on the fate of GSK’s Avandia. I guess you could literally call this agent a wonder drug — as its continued availability in the Pharma marketplace in spite of hundreds of class action lawsuits, multiple studies stretching back to at least 2005 documenting a clear association with an increase in heart attack risk, and copious physician calls for its withdrawal — continues to amaze healthcare policy watchers.
For the first time it appears that the handwringing on both sides of this hotly debated drug (Pharma/GSK vs. medical critics) appears to be taking on an overtly political tone, as even within the government agency itself, there is a deep devision over just how this entire case should be handled. The hoopla surrounding the removal of Vioxx and Bextra (anti-inflammatories with similarly documented cardiac risks) was never this contentious. Even U.S. senators have weighed in on the issue.[1] What will the fate of this drug be? Tighter restrictions on its use, or complete removal from the pharma marketplace? Perhaps the answer says as much about the FDA as it does about GSK. | LINK
Add yet another blow to GSK’s once-blockbuster diabetes drug, Avandia (rosiglitazone). The ongoing soap opera that is this drug’s manufacture and continued presence begins another chapter in its struggle to retain some semblance of competition in the pharma marketplace. Avandia’s troubles and brushes with near-market revocation are greater amidst news of the FDA considering axing its inclusion in a safety study involving itself and its much safer congener, Actos (pioglitazone).
The concerns over Avandia’s possible involvement in increasing death due to cardiovascular problems are legion and stretch back at least nine years, with its most recent actions coming this past February — as Senators Max Baucus (D-MT) and Charles Grassley (R- IA) released a report on the drug in February as well as a 2008 memorandum from two FDA drug safety reviewers who recommended pulling the drug from the U.S. market. | LINK
Conflict of interest takes on an entirely new meaning in the latest on the ongoing issue regarding physician disclosures as it relates to medical device companies. Iowa Republican Senator Charles Grassley (Finance Cmte.) has been investigating the roles of Pharma and device companies and their ties to physicians who reap significant remunerations from the participation of those physicians in the promotion of their products.
At issue here at the University of Minnesota medical school is the involvement of one of its most highly regarded research and clinical faculty; perhaps more problematic than the more than $1M this physician pocketed from such arrangements is the apparent inaccurate and evasive testimony he gave to the senate committee invetigating the matter. Additionally, he may have misrepresented himself to the medical school’s own ethics committee.
Grassley’s work in defining the poorly understood world of physicians’ ethical violations and conflicts of interest of this nature is to be commended. Payouts such as this do nothing to increase the confidence of the American public in an administration committed to lowering the cost of healthcare in this country. The clandestine million dollar exchanges between well-profited device companies and physicians who “take the money and run” offer a tremendous example of the clash of physician morals, responsibility to the guaranteed delivery of healthcare to patients, and his or her duty to disclose honestly any ancillary fiduciary relationship to the public. | LINK | PDF summary of Finance Cmte. report
On Wednesday, the chairman of the panel, Senator Max Baucus, Democrat of Montana, and the senior Republican, Charles E. Grassley of Iowa, unveiled a set of detailed recommendations intended to slow the growth of Medicare, hold doctors and hospitals more accountable, and improve the care of patients with chronic illnesses. Mr. Baucus said the changes in Medicare could be an engine driving a “transformation of the health care delivery system.” After a six-hour meeting to discuss the proposals with members of both parties, Mr. Grassley said, “I did not find a lot of dissension.”
The NYT is reporting that, because mainly of allegations made by Sen. Charles Grassley (R-IA), a medical publishing company plans to investigate an article “improperly” ghostwritten by pharma giant Wyeth to promote its patented estrogen, Prempro. Medical ghostwriting is not a new practice. It’s merely just another promotional tool in marketing a pharma company’s product, end user beware. The problem arises, however, when the ugly spectre of misrepresentation occurs. Intentional or apparent? | LINK
Originating from Saint Paul, Minnesota, [doctorpundit.com] is a weblog about the policy of healthcare and where it intersects with politics and public opinion; it is edited by Michael Douglas, MD, MBA. Welcome, and please consider my take on what is Healthcare 2.0, complemented by a few of my thoughts on my personal avocations and guilty pleasures: music, prose, and writing. Follow Doctor Pundit via RSS above.
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DOCTOR PUNDIT @ ONE YEAR | An occasional DP series from 2010 highlighting healthcare policy trends over the period from 2009-2010 in a compare/contrast format.
