Lately, Doctor Pundit has been reporting some tidbits from the arena of medical research. Here are a few more to make the wires for 9/1.

• Is it really possible? For now you’ll just have to ask the mice taking it. Metformin, the country’s most widely used antidiabetic agent, could lead to the prevention of lung, breast, and prostate malignancies. | LINK
• Speaking of cancers, are certain heritable forms of breast cancer prevented by a certain surgical technique? | LINK
• Again, on the topic of cancer: an anti-tumor drug may be altered to serve as the basis for a novel agent to prevent the formation of senile plaques seen in the central nervous system in virtually all Alzheimer patients. | LINK
• Finally, on the lighter side of things — the all-star line-up for the “Stand Up to Cancer” telethon is almost finalized. | LINK

The huge drive to immunize the masses against threat of H1N1 in the 2009/10 influenza season (which the WHO has officially declared concluded) has created more than a watershed moment in 21st century public health response to a potential biological catastrophe, it has also touched off a political debate that’s just getting started. And it all has to do with authoritarian mandate of the vaccine for healthcare workers.

Contrary to popular thought, many healthcare workers do not receive the vaccine; in fact, approximately 40 percent of said workers actively refused [PDF link] the vaccine last year — during infection’s peak. This notion does not sit well with a couple of policy organizations — one academic and one medical. Both groups say mandatory influenza vaccine should be a condition of employment. The groups stress increased availability of the vaccine, a steadier supply of healthy workers to administer care in times of a crisis, and an overall decrease in the incidence of influenza-related deaths in already compromised inpatients with other medical problems.

Already, the state of New York is hard at work in developing regulatory actions for its public healthcare workers. | LINK

The AARP today released a watchdog analysis (using Medicare claims data) depicting the general increase in the price of the most popular prescription medications relative to prevailing inflationary trends. And, surprise! The lobbying group notes an almost 10 percent increase in the price of branded preparations straight from the manufacturer for 2009. Apparently, all but 6 of the over 200 brands studied showed any increase over the rates of inflation for that period. Pharma is quick to dispute the group’s findings as they do not include more precise reporting of actual point of purchase data to the consumer, forgoing mentions of rebates and plan discounts. | PDF LINK of AARP’s report

Pharma company Eli Lilly recently scrapped further development of an anti-Alzheimer drug designed to fight the disease from the plaque mechanism; its compound would inhibit the enzyme responsible for catalyzing the process in forming the amyloid plaques pathognomonic for the disorder.

Their reasoning? That the enzyme also works on the formation of other proteins in the brain that have no consequence in the natural histopathological history of the disease. Scientists working on the R&D for this drug have also gone as far as to question this hypothesis as a valid point of research into anti-Alzheimer development. The implications of these second thoughts have yet to be fully realized, but there could be an immediate effect on other Pharma companies researching similar treatments for degenerative dementia should they decide to follow like concerns. | LINK

I know Facebook exists, but I am not part of its ever-growing half-a-billion member network. But a pharma company apparently is. Novartis — maker of such patented mainstays as Lotrel and hot seller Diovan — was sent a notice by the FDA in which the government agency accused the drugmaker of violating Facebook terms in relation to their misleading potential consumers over a leukemia drug.

Once the drug info is viewed on the popular social network, users can spread the word about all of its benefits, but about none of its risks. In the ad for the drug, claims were made that it outperforms other anti-leukemia drugs on the market; those claims have not been proven. | PDF LINK

In addition to re-evaluating its pharmacotherapeutic review process against the backdrop of reform, the FDA is proposing changes to its medical device review process. Essentially, it’s focusing on the scheme in which medical device makers have to prove their product is similar to one already in the marketplace before launching it commercially. This proposal may be in response to critics of the present process, which bypasses clinical trial rigor — potentially releasing an unsafe device to public. Other points the FDA is considering:

• Making the approval process smoother for so-called medical devices brand-new to the market (novel), as those would not be similar to a product currently on the market but are still relatively low-risk.
• Issuing guidelines on when a device on the market shouldn’t be used as the basis for approval of a new device; so that approvals cannot be based on an unsafe product.
• Issuing alerts/bulletins to medical device makers to better communicate changes in preapproval expectations.

LINK

Confirming what many, if not all providers in healthcare delivery already know, a study in the Annals of Int. Med. confirms the rampant favorability of results in pharma industry sponsored trials. In the meta analysis of over 500 trials, researchers found that industry-funded trials received positive outcomes approx. 80 percent of the time, compared to positive outcomes in just 50 percent of government-funded ones. Also, results of industry-funded studies were published within two years of study completion 32 percent of the time compared with 54 percent for government trials — suggesting not only certain bias in reporting in heavily invested outcomes, but also that government funding occurs sooner in trails when results may not seem as certain to produce a favorable outcome. The government’s registry of trials in development provides excellent information on study quality of over 90,000 investigations for those interested in getting at the true purpose of a proposed clinical trial. | LINK

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.

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

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

1. Sens. Baucus and Grassley published a report questioning the FDA’s rationale for keeping the drug available while GSK knew about the drug’s risks. [↩]

Although the results of a study from the Annals of Internal Medicine are out today noting an increase in the rate of sexually transmitted infections (STIs) among those taking drugs for erectile dysfunction, this item “hot off  the wires” practically invites the media to take a stance assuming direct causation.

Jokes aside — and you can assume that lead-ins are probably replete with them — the compelling numbers^[1] suggest a greater problem afoot: the overall numbers of sexually active men over 55 years of age is increasing. Re-evaluating incidence and prevalence rates to include this ever-burgeoning population will only become more commonplace in medical education as this retrospective study underscores one major point: the necessity of other types of trials studying the effects of preventive practices toward STIs in those much younger and applying them to this patient population. | LINK

1. Researchers followed over 1M men (average age of 60) by examining their insurance records. Among non-users of drugs like Viagra, 106 in 100,000 contracted an STD. That number increased to 214 in 100,000 for men who were using Viagra, Cialis or Levitra — the major drugs to treat ED. [↩]