The FDA has announced today Avandia’s official indication. After months of teetering on the brink of availability many times over, GSK’s once star performer has now been relegated to last-ditch status. As of today, Avandia will be restricted to patients with type 2 diabetes whose condition cannot be controlled with other medications. Further, The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Per the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos, the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Although it may be too early to determine what this ruling will mean for GSK, the FDA is clearly sending a message to the Pharma company with respect to its availability in the U.S.[1]: further sales come with a hefty price. It’s hard to imagine many physicians determined enough to pursue dispensation of this drug when so many safer and saner options abound. | LINK
Most — if not all — state regulatory boards of medicine are able to compel the investigated healthcare provider in virtually all cases that come before them. It took a Massachusetts psychiatrist to challenge that state’s medical board on issues of patient confidentiality. In a case involving the anonymous psychiatrist’s pain management of a handful of patients, the Mass. supreme court ruled that the physician had the right to deny a subpoena by the Massachusetts Board of Registration in Medicine requiring the provider to submit records — nixing the board’s contention that it has a duty to uphold public safety at all costs (safety trumps confidentiality).
Paul R. Cirel, the Boston lawyer who represents the doctor, said in an interview that the board already has access to the records of all controlled substances prescribed by Massachusetts doctors. The ruling, he said, clarifies the state’s psychotherapist-patient privilege and prevents the board from obtaining records about the private relationships between therapists and patients.
The board’s investigation found that the psychiatrist’s narcotic prescribing patterns involved over 200 patients — with over 80 percent being prescribed oxycodone, 77 percent being prescribed diazepam (Valium), and a like number prescribed both. | 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
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
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
A couple of weeks before the FDA meets to discuss the safety of the antidiabetic medication Avandia come (coincidentally) more reasons this agent should be withdrawn from the pharma marketplace. One study concludes that Avandia increased the risk of death, heart failure, stroke or heart attack by almost 20 percent compared with its main competitor, Actos. Another trial noting heart-attack risks associated with Avandia found that one of every 52 patients using the drug had an almost 33 percent increased risk of getting one.
Not to be outdone, the pharma manufacturer of Avandia — Glaxo Smith Kline — is standing by the troubled drug, releasing a statement saying that randomized trials show it is, indeed, safe; the American Diabetes Association agrees, saying there is no increase in overall mortality from the drug — independent of its effect on one’s risk of cardiovascular complications. Physicians have gone on record as being, at the very least, circumspect on the safety data trumpeted by GSK — noting flaws[1] every step of the way. | LINK
Unlocking Medicaid fraud can be as tortuous and labyrinthine a process as making sense of the legislation itself. Often, grandiosity characterizes elaborate institutional methods involving private entities bilking the government out of untold billions that essentially are absorbed by the government even after prosecution of the offenders — only adding to the cost outlay of the entitlement program.
Alternatively, fraud indirectly involving Pharma is fast becoming an issue because, for certain populations, Medicaid has been responsible for much of the cost of care delivery via drugs — many of which are branded. Where the legislation should draw the line, however, is in the unauthorized use of many of those medications explicitly granted a warning by the FDA as prohibited. Drugs used to treat mental illness — particularly as unauthorized in children, and reimbursible under Medicaid — fall squarely within this class of rules.
Nowhere is this occurring as rapidly as in the child foster care system, in which these children — often burdened with multiple placements, obvious parental neglect, and the influence of illicit drugs and criminal environments — are exposed to rather abusive prescribing practices by providers using psychotropics to treat what amounts to a troubled lifestyle … instead of frank mental illness. | LINK
What is known about the H1N1 epidemic that plagued the world in 2009 was its influence in global approach to this infection — for good or bad — and the costs to nations which chose to meet its threat head on. What wasn’t known at the time (but may be increasingly apparent if many European countries have their say) is that the trajectory of the influenza strain’s influence as a major media event may have been manufactured, by, of all entities, Pharma and its association with the World Health Organization. The concerns are outlined in an 18-page report criticizing costs deemed by many nations as unnecessary, as were “amplified” fears at the hands of the organization in galvanizing support for guidelines influenced by Pharma makers of the H1N1 vaccine.
Calling the WHO and its response to the H1N1 epidemic “exaggerated” and “lacking credibility”, many European nations are quite vexed that, among other things, guidelines issued by the WHO in response to what it termed as an epidemic came from consultants who received much in the way of fees from two leading Pharma manufacturers of the vaccine that would prevent the virus’s spread: Roche and GSK. The WHO has opened up its own international investigations into the matter — one of which involves the Institute Of Medicine on these shores.
The WHO asserts no potential for conflict of interest within its ranks, as this appears to be the central question in this entire matter. | LINK
One look at the infographic below, and you’ll see that alrazolam (Xanax) was the most prescribed psychotropic in the U.S. last year. Interesting, but not surprising. Via GOOD. | 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
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.
