DOCTOR PUNDIT » Science & Research

Poll: Negative Attitudes & Beliefs about Reform Trending Downward

Michael Douglas, MD, MBA — Fri, 30 Jul 2010 13:10:57 +0000

Republicans and Dems are waiting to see just exactly how public opinion continues to be shaped on the issue of healthcare reform in this country in the run-up to the 2010 mid terms. If the results of a new tracking poll [PDF] are any indication, there is comfort for the latter party.

The July Health Tracking Poll indicates overall public support for the health reform law is steady from June, while unfavorable views of the law have trended downward. Half the public (50%) now expresses a favorable view of the law, while 35 percent say they have an unfavorable opinion (down from 41% in June).

The results don’t exactly show that misconceptions do exist, however.

[L]arge shares of seniors mistakenly believe the law includes provisions that cut some previously universal Medicare benefits and creates “death panels.”

Results are over at the Kaiser (kff.org) website, a link from this blog in the Blogroll.

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Report: FDA Pharma Approval Process Undermines Patient Access to Timely Healthcare

Michael Douglas, MD, MBA — Wed, 28 Jul 2010 15:58:46 +0000

A conservative health and public policy think tank reports on the consequences of a federally managed pharmaceutical approval and regulatory process and how that impacts patient access to timely and appropriate care — with respect to pharma availability. The Pacific Research Institute released its white paper detailing what it describes as the bureaucratic morass of “stymied pharmaceutical regulation” within the FDA’s drug approval process. A snippet:

During a 12-month period in 2008 and 2009, the European Union’s European Medicines Authority (EMA) and the Food and Drug Administration (FDA) approved a total of 39 new medicines. Fifteen were approved only by the FDA, 11 were approved only by the EMA, and 13 were approved by both regulators.

In five of the 13 cases where the FDA and EMA both approved the medicine, the EMA was the first to approve, and it issued those approvals 552 days faster than the FDA, on average. Even if we include all 13 medicines approved by the FDA and the EMA, the EMA approved those 97 days faster, on average.

The report goes on to describe the effects on impassive procedures of the FDA and its correlation to unnecessary medical tourism for similarly approved pharmacological treatments elsewhere. Although the report confirms what we all know about the costs of healthcare respect to governmental and regulatory mechanisms, perhaps this is another area in which Obama’s pick to head another regulatory agency addresses the need to apply quality and efficiency to the rather staid and arcane process of pharma approval.

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NEJM Updates Website for 21st Century Medical Education

Michael Douglas, MD, MBA — Sun, 25 Jul 2010 17:41:17 +0000

The New England Journal of Medicine, long a standard in peer-reviewed medical research, has updated its website and become a portal of an essential library of text, audio, and video — a thriving primary online brand of itself. What a treat.

Our electronic archive now includes every issue back to the first one, published in 1812. The NEJM Archive from 1812 to 1989 has more than 150,000 articles. All articles are fully searchable, with the content back to 1945 presented in an HTML format similar to that for the current issues. For all the articles in the archive, the PDF files show the original versions as they appeared in print, complete with ads, notices, and various curiosities from earlier eras.

Nice. It was enough for me to subscribe to the Journal (and its online content) for the first time in over 10 years. | LINK

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FDA Rejects Plan to Increase Controls on Opioid Prescribing

Michael Douglas, MD, MBA — Sat, 24 Jul 2010 13:55:49 +0000

Besides making news on the antidiabetic treatment front recently with Avandia, the FDA has also been tackling the push by some advocacy groups to tighten or restrict the use of some opioid medications — most notably drugs like oxycodone. The FDA voting panel rejected concerns of its various advisory panels on the subject to enforce the restrictions (it usually follows its advisory recommendations).

Had the agency gone ahead with the recommendation to restrict usage, providers giving the drug would have been subjected to special training based upon the new rules for prescribing. At this time, only registration with the DEA is needed for physicians to give most opioids. Perhaps due to political pressures from providers and systems involved in chronic pain treatment, the FDA did not want to go down that road at a time when reform will probably produce more bureaucratic weight on the agency than what it can normally endure. Here’s to a sound decision on that point. | LINK

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FDA Tells Pharma Co. to Halt Recruitment for Its Own Safety Trial

Michael Douglas, MD, MBA — Thu, 22 Jul 2010 14:55:33 +0000

Embattled pharma company GSK may be celebrating the continued availability of its once-blockbuster drug Avandia on the market, but it’s bemoaning the fact that the FDA is putting the breaks (halting recruitment) on a safety trial it has begun initiating in an effort to restore positive PR for its troubled drug. As part of its 20-12 ruling to keep the drug on the pharma market, the FDA is also requiring the IOM to investigate the ethics surrounding GSK’s commission of the trial.The study, though not officially canceled, is suspended while the FDA continues to soak in the data and come to its own definitive conclusions regarding the safety of Avandia. | LINK

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Under Reform, Insurers Will Cover Certain Preventive Medical Costs

Michael Douglas, MD, MBA — Fri, 16 Jul 2010 13:26:49 +0000

The U.S. Preventive Services Task Force, an independent, non-partisan body made up of primary care physicians involved in developing preventive medical guidelines based upon evidence-based medicine, has always reveled in its staunch self-governance. That could change ever so slightly in the new age of health reform.

The academic research-oriented group will continue to make recommendations on best-preventive practices and supply ratings (“A”, “B”, etc.); but this time, under reform, insurers will be required to cover services that receive such a rating. The Obama administration hopes that this increase in access (which will require a small premium increase by insurers in the near term) will reap savings in the future — as costs for preventive testing, screening for certain chronic diseases, vaccinations, and well-child visits would be covered (without health plan co-pays and deductibles) if so rated by the USPSTF.

Besides having to consider methodology involved in formulating its ultimate recommendations, the group will also have to contend with the specter of political agenda setting if lobbying groups and disease advocacy organizations have their way under this bit of legislation — scheduled to go into effect in September. | LINK

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Research Trends Positively Influence Approach to Alzheimer Dementia

Michael Douglas, MD, MBA — Thu, 15 Jul 2010 19:59:16 +0000

Research into better treatments and possible cures of Alzheimer dementia is one of the bright spots in the potential for better healthcare delivery in the decade of the 2010s. There are many signs that bode well for the approach to this disorder at the dawn of the second decade of the 21st century.

New research into alternate pathways of disease development is starting to generate excitement among primary care physicians and geriatricians (such as myself) as potential arenas for new classes of drugs to combat Alzheimer’s. Better care delivery models in long term care of the elderly as part of new initiatives in the Affordable Care Act are already starting to impact chronic disease care management strategies.

Perhaps most important, there is new evidence to suggest that earlier detection of this cognitive disorder can enhance those developments, and more. At an annual meeting of top dementia researchers, guidelines were proposed to expand on the research from the ’00s to diagnose the disorder earlier — a strategy that benefits more than just those potentially afflicted with Alzheimer’s.

If the guidelines are adopted in the fall, as expected, some experts predict a two- to threefold increase in the number of people with Alzheimer’s disease. Many more people would be told they probably are on their way to getting it. The Alzheimer’s Association says 5.3 million Americans now have the disease.

Heavier use of newly discovered biomarkers for earlier detection of the pathology behind Alzheimer dementia will be a closely watched process by both physicians and health policy analysts alike. | LINK

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FDA Discussions on Avandia Enter 2nd Day

Michael Douglas, MD, MBA — Wed, 14 Jul 2010 11:32:26 +0000

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.

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Report: Pharma Company Covered Up Known Cardiovascular Risks of Drug

Michael Douglas, MD, MBA — Tue, 13 Jul 2010 14:56:46 +0000

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

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Obama Announces First National HIV Policy Strategy

Michael Douglas, MD, MBA — Mon, 12 Jul 2010 14:17:10 +0000

HIV is once again in the news lately — first with news of a new strategy to combat the infection with enhanced vaccination research, the commitment of HHS in reallocating funds for HIV research on a global scale, and now the creation of the first “national HIV strategy” by a sitting president.

In the report, the administration calls for steps to reduce the annual number of new H.I.V. infections by 25 percent within five years. [..] [T]he administration will redirect money to areas with the greatest need and population groups at greatest risk, including gay and bisexual men and African-Americans.

Obviously, simple “redirection” of federal funds for medications and treatments of HIV/AIDS is not the final mechanism of care access for the millions of patients afflicted with this chronic disease; it is unclear where these funds will provide an absolute siphon for spending. Kudos to the administration in its efforts to reacquaint an entirely new generation of Americans on the urgency of this disease, but it’s got a long way to go to reduce sharply its transmission rates and healthcare policy atrophy in this area. | LINK

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