Wednesday § March 10, 2010
A major focus of President Obama’s healthcare reform initiatives included over $1B in funding for comparative effectiveness research — a discipline designed to study the most efficacious, efficient, and low-cost methods for healthcare delivery. Perhaps the most basic scenario is defined by the study of two different pharmacological therapies for the same problem. A trial published in this week’s JAMA states, however, that relatively few studies were devoted to this research modality, a cornerstone of Obama’s pledge to research better ways to deliver healthcare more cheaply. Only a third of 328 studies published in six top medical journals from June 2008 through September 2009 met the definition of comparative effectiveness, according to the investigators.
Naturally pharma companies aren’t invested in such matters, with the majority of funding for CE trials paid for by public sources. Typical pharma-financed trials are usually designed to show positive results. Although the need for unbiased, pure research is high given Obama’s admirable concern for such resource deployments, the road to drug research using such models is a long one filled with roadblocks — as long as Pharma has a stake. Perhaps a better way to ensure greater adoption of this initiative is not only to earmark a steady stream of federal funds targeted at comparative effectiveness research, but also to compare newer treatments with longstanding existing modes of treatments (pharma or otherwise) whenever possible.
RELATED: House bill concerning CE [PDF] | Senate bill [PDF]
Saturday § February 20, 2010
Tuesday § January 26, 2010
Given time, anything can be politicized. Take the hysteria surrounding influenza A. Seems as though, since 9/11, the issue of mass casualties — be it via any cause — has, as a matter of policy, become a staple political topic among many policy organizations, governments, lawmakers, think tanks — you name it. With the formation of the Department of Homeland Security, protecting this country against the real or perceived threat of terrorism has become a necessary, yet arduous task, on the road toward providing and maintaining its national security. Military might is understood; in fact it is one of the exemptions President Obama seeks to the spending freeze he’ll announce at the SOTU address on Wednesday.
The spectre of biological warfare is another issue.
Read the rest of this entry »
Tuesday § November 24, 2009
Pharma company Merck withdrew the popular anti-inflammatory agent Vioxx (rofecoxib) from the marketplace in 2004 for increased risk of death due to adverse cardiovascular events, including death. This followed testimony from that company’s CEO before a committee in the Senate in which he said that there was no difference in cardiovascular risk between this drug and placebo — based upon “combined data from randomized controlled clinical trials”.
Could the CEO have been relaying data based upon selective manipulation or interpretation of trial results? This combined data he was referring to was the result of meta-analyses, or pooled trial results from several smaller studies utilized to obtain more favorable results better than individual trials alone. Increasing the statistical power meant that this statement could have been made, as trials involving rofecoxib up to late 2001 had results based upon outcomes data involving bleeding — but not clotting (the major risk associated with the cardiovascular deaths in the plaintiffs’ cases against Merck). Read the rest of this entry »
It’s official. The FDA will NOT withdraw propoxyphene-containing drugs from the market. Known better as Darvon and Darvocet (with acetaminophen), these products stirred controversy when pharma watchdog groups petitioned for their recall, based upon their arguments and spin on adverse effects. The move is probably seen as a relief to pain specialists who routinely give such potent narcotics in their practice. With all of the recent brouhaha surrounding acetaminophen (Tylenol) and its current review, the fear of providers’ livelihood in the medical specialty of pain management has just been abated somewhat.
Kevin, MD has some great reportage on this issue. Essentially, the FDA’s new maxim of transparency and policy change for the benefit of public safety under new leadership has been a clarion call for third parties (mostly watchdogs) that desire greater restrictions to access to certain drugs. Pain agents, currently represented by Tylenol, are just the latest class of drugs in the groups’ crosshairs. Unsurprisingly, a different set of lobbying has emerged in this respect: physicians and pharma companies who have major stakes in their products’ availability. | LINK
In the march toward his overall healthcare reform plan, President Obama has reversed a George W. Bush administration regulation that gave the feds the ability to trump state governments’ decisions concerning liability with medical devices. Device makers were essentially shielded from healthcare consumer lawsuits Bush generally deemed as “frivolous” in nature. Also, Big Pharma was helped by such actions since the FDA often did not follow regulatory guidelines in implementing new drug indications.
Obama in a two-page memo wrote that federal agencies and departments could claim state law is pre-empted by federal law only when there is a well-defined legal basis. The memo stated that state laws are important because they supplement federal regulations. “State and local governments have frequently protected health, safety and environment more aggressively than has the national government,” Obama wrote.
If efforts at stopping government pre-emption give the patient more of an incentive in trusting public delivery of healthcare, at the same time cutting massive bureaucratic waste from lack of government regulation in healthcare delivery, this effort of Obama’s is to be praised. On the contrary, concerns over a flurry of patient lawsuits from Republicans should be a nonissue since Obama acknowledges the rights of individual states in this case. | LINK
Out of the distribution of the hundreds of billions President Obama has signed into law as part of the ‘09 Recovery & Reinvestment Act, it’s easy to overlook the relatively “minor” earmarks as part of this stimulus package with respect to his commitment to healthcare reform. One of those areas is in pharmaceutical research. However, it probably isn’t what you’re thinking when you hear that word.
Via his healthacare stimulus package, Obama has asked for researchers to study the effectiveness of drugs after they have gained approval by the FDA. Strictly speaking, comparative effectiveness research, as it’s called, is the study of utilization patterns, costs due to procurement, costs due to adverse effects, insurance coverage, and expected outcomes among drugs in certain classes. This data compares drugs in the same pharmacologic classes to find the most economically efficient and medically effective ones. It’s just another tool to examine the effect of a major source of the cost of healthcare today — the pharmaceutical industry. | LINK
Medicaid fraud is so pervasive, it’s hard to believe any serious effort at reform will get much traction anytime soon, at least before significant changes in Medicare occur. All any healthcare policy wonk can do is sigh.
The court papers claim that between 2000 and 2006, Wyeth offered steep discounts to thousands of hospitals for two versions of [pantoprazole], a drug that suppresses stomach acid. By law, manufacturers of brand-name drugs are required to offer the same rebates to state Medicaid programs that they provide to other customers.
Rebates offset the cost of drug for negotiating entities who chose to cover it. There is a loss to the pharma company, of course. But one can only surmise that Wyeth thought that even this amount was just too much of a liability to bear on its books. | LINK | US DOJ news release here
The association between certain newer antipsychotic drugs and glucose intolerance, a pre-diabetic state, has always been the bane of patients, their prescribers — let’s not forget — the poor, hapless pharma manufacturers which market them. Time to give Pfizer and its blockbuster Zyprexa a break and now place the focus on AstraZeneca and its huge seller, Seroquel. Otherwise known by its generic name, quetiapine, Seroquel has always enjoyed a reputation of crossover utilization between psychiatry and primary care; this is due to its versatility in treating both psychosis and lesser “acute” states: everything from an FDA indication of bipolar disorder to the mundane diagnosis of primary insomnia. All of this and a low potential for psychological dependence, to boot.
This extreme breadth of written prescription power at the hands of multiple specialties and the drug’s perceived versatility has made it a solid perfromer for AstraZeneca on Wall Street. Although the potential for the patients who take Seroquel to develop overt diabetes mellitus is definitely more than theoretical, the bad press its congener cousin Zyprexa has received over the issue has created and maintained the spectre of Seroquel’s relative safety among prescribing healthcare professionals. That is…until now. Read the rest of this entry »
Tuesday § February 10, 2009
Sometimes, one just has to wonder how the FDA prioritizes things. In an otherwise boring year in which very few NDAs will be introduced, I guess we have our answer: time to get serious about tighter regulations on the patterns of prescription narcotic writing in this country. The organization is just now paying attention to this issue? Apparently so.
Yesterday, the FDA announced it was stepping up efforts to reduce unsafe use of some 24 narcotics products — methadone pills, fentanyl patches and extended-release pills containing morphine, oxymorphone and oxycodone — all agents and formulations with a well known propensity for drug dependence and street trafficking. Alrighty, then. | LINK
