Category Archives: Patents

Evidence that bexarotene decreases the amount of amyloid in the brains of mice and improve cognitive functioning is causing massive reaction in the Alzheimer’s disease community. 

The drug, bexarotene, whose trade name is Targretin, quickly cleared abnormal plaques of a protein called beta amyloid from the brain and improved memory in three different mouse models of Alzheimer’s disease, according to a study published Thursday in the journal Science. Beta amyloid is just one feature of Alzheimer’s disease in humans.

The article in Science from Case Western Reserve University found:

Oral administration of the RXR agonist, bexarotene, to a murine model of Alzheimer’s disease resulted in enhanced clearance of soluble Aβ within hours in an apoE-dependent manner. Aβ plaque area was reduced >50% within just 72 hours. Furthermore, bexarotene stimulated the rapid reversal of cognitive, social, and olfactory deficits and improved neural circuit function. 

Bexarotene is approved for use in a rare skin malignancy T cell lymphoma and, as such, has had mixed benefits.  The fact that it seems to benefit mice, however, provides great hope for those with Alzheimers.

Medicynical Note:   There is always a but when advances are postulated without proof and for bexarotene there are several.  There is no evidence, none, that in humans it will have a similar profound effect in cases where the disease has progressed—or even in early cases.  At a cost of over $1000/day the drug is unaffordable.  Lastly, The drug is a close relative of Accutane a drug that has severe and often unacceptable side-effects.  For the drug to have a use in a chronic progressive disease it would have to be used continually and for long periods of time.  Anticipated and unanticipated side effects are likely. 

That being said I look forward to further study of the drug. 

A word of caution, only a small number of “miracle advances” turn out to be miraculous.

Nice clear explanation of accountable care and global payments:

  It is widely acknowledged that continued growth in health care spending is threatening the viability of the U.S. health care system. Although there are no clear comprehensive solutions to this problem, most observers see payment reform as the next best hope for reining in out-of-control costs. Our current fee-for-service payment system provides incentives to physicians to increase the delivery of services, which results in excessive utilization. Moreover, neither individual physicians nor the patients receiving the services bear the brunt of these utilization decisions. Rather, they’re reflected in ever-rising health insurance premiums or tax-financed government expenditures shared by all. Many observers are therefore calling for fundamental redesign of the ways in which physicians and hospitals are compensated for the care they provide. Most options call for bundling payments to physicians; specific approaches range from prospective payments for discrete episodes of care (e.g., coronary-artery bypass surgery) to global payment or risk-based models of care.

And:

Conceptually, global payment represents an important opportunity for changing the perverse incentives inherent in our current fee-for-service system. To be successful, however, ACOs must pass these incentives along to their member physicians, who continue to be responsible for most utilization decisions. Although organizations can implement various managerial strategies to influence physicians’ decision making (e.g., radiology decision support and prior authorization), ACOs are unlikely to reduce the rate of increase in health care spending without some essential changes in the behavior of member physicians — and therein lies the rub. The fundamental questions become how ACOs will choose to divide their global budgets and how their physicians and other service providers will be reimbursed. Thus, this system for determining who has earned what portion of payments — keeping score — is likely to be crucially important to the success of these new models of care.

Read the article to understand the ACO’s and our global payment future.

Medicynical Note:  What’s missing from these interventions is control of the constant upward pressure on health care costs from suppliers, often with patent protected monopolies. 

It’s hard to imagine a single diagnostic test costing thousands, single drugs of any sort, much less ones of questionable efficacy, costing more the average and median family income for a year.  Yet that is the reality in our current non-system.  Until these excessive and irrational cost issues are addressed the system will continue to fail.  Health reform is a start but reining in profit expectations at all levels and patent reform are additional needs. 

But, always a but, with our Congress in the pay of medical industrial complex real cost containment seems a long shot.

The New England Journal of Medicine (NEJM) (Oct. 12, 2011) looks at the proposal to require drug companies to offer low income Medicare beneficiaries the same prices given Medicaid recipients:

Seems like a reasonable money saving idea but:

Reducing Part D payments for low-income beneficiaries, it is argued, could undermine incentives for the pharmaceutical industry to invest in research and development, as well as create illusory savings by shifting drug costs to other parties. In considering the wisdom of such deficit-reduction proposals, it’s important to consider how well the market is working for Part D and whether there are important inefficiencies that can be eliminated, resulting in budget savings.

It is pointed out however that the market doesn’t seem to work well with the indigent elderly who most often of the medicare group have multiple chronic conditions (30% of the group) and spends more on drugs than others in the medicare group.

It concluded that:

The approach obtains savings without undermining incentives for developing important new medical treatments. The anticipated side effects would be outweighed by the size of the estimated budget gains. This is as close to a win–win solution as we can get.

Medicynical Note: Put pressure on drug companies to offer more affordable drugs, why that may be Un-American. Consider that drug companies spend more on marketing than research; pay nothing to the government for drugs developed from government funded research; all have increased their prices and revenue by incredible amounts during a recession/depression.

Big PHarma will oppose this initiative preferring that we continue to pay more for drugs than any other industrialized country in the world. That’s really Un-American.

It’s been a long time coming but companies in China and in other emerging economies are finally tiring of the outrageous pricing of drugs by U.S. and other western drug manufacturers. Charging more for a drug, than people earn is not an acceptable business practice in my view. Blackmail would be a more honorable business practice than the drug companies practice of charging more for drugs that might benefit (most don’t have a significant effect) those with serious life threatening illness.

So, it appears drug manufacturers elsewhere are producing these new drugs at a fraction of the cost.

Chinese and Indian drug makers have taken over much of the global trade in medicines and now manufacture more than 80 percent of the active ingredients in drugs sold worldwide. But they had never been able to copy the complex and expensive biotech medicines increasingly used to treat cancer, diabetes and other diseases in rich nations like the United States — until now.

Medicynical Note: 80% of the world market supplied by drugs made in China and India. Amazing.

The drug industry does everything it can to influence physician’s and patient’s treatment decisions. They spend more on drug promotion than on drug research. They have innumerable physicians, research and practicing, on their payrolls–by offering grants, honorariae, or simply putting them on salary. And it works, it’s well documented that these conflicts of interest influence physician’s choices of treatment.

So it was not surprising to learn that these companies “data mine,” review records of prescriptions at pharmacies, to learn what doctors are prescribing and where to put their emphasis as they propagandize. What is surprising is the recent Supreme Court decision that it is unconstitutional to limit the right of drug companies access to these confidential records.

Concern about detailing has prompted at least 25 states to consider legislation to curtail it by restricting the transfer and use of physician-identifiable prescribing data.13 Laws passed in 3 states — Vermont, New Hampshire, and Maine — were swiftly challenged by PDIs and a trade association of pharmaceutical manufacturers.14-16 One of these challenges reached the nation’s highest court this year, and on June 23, the Supreme Court struck down Vermont’s statute by a vote of 6 to 3,17 holding that in practical effect, the law unconstitutionally restricted the speech of pharmaceutical companies and PDIs on the basis of the viewpoint it expressed. In this article, we review the Court’s reasoning and examine the implications of its holding.

What’s remarkable is that the Court views this a “freedom of speech” issue, once again elevating corporations to the level of citizenship. (As they did with political contributions)

The NEJM concluded:

The Sorrell decision impedes states’ efforts to curb detailing. Clever lawmakers may, however, be able to write their way around the Court’s ruling. The decision might also offer an unexpected dividend to opponents of data mining: the surrounding publicity might alert physicians to their right to opt out of sharing their prescribing information through the PDRP. Although the Supreme Court swept aside data-mining laws with the stroke of a pen, physicians who object to data sharing can escape it with the click of a mouse.

Medicynical Note: Our single minded Supreme Court appears to value the “citizenship” of corporations over individuals. Money appears to be a form of free speech whether in the form of political contributions or the ability to unduly influence prescribers in our non-system of health care. More American Exceptionalism.