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
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
A safety review of GSK’s Avandia, under fire and intense scrutiny for its role in the possible development of cardiac adverse effects is nearing completion. In spite of the continued negative press, the pharma company has issued a thirty page rebuttal [PDF] of the Senate Finance Committee’s report alleging those safety issues.
The pharma company faces an uphill battle. In the wake of 24-hour, always on news cycles which seemingly filter only stories of negative sensationalism, it should be taking its damage control cues from Toyota these days.
Among the report’s most “glaring omissions” is its lack of discussion about the final results of the ADOPT, DREAM, or RECORD trials, the company said in a release. It said data from these three trials were reviewed by an FDA advisory committee in 2007 that voted overwhelmingly to keep rosiglitazone on the market.
Perhaps, but the issue now is that GSK chose to keep this information from the meta analysis of these trials from prescribers and patients, according to the Cleveland clinic physician responsible for bringing this data to the forefront. | LINK
The test was developed as a part of a new medical field called genomic medicine, which enables doctors to further personalize patient care based on the unique genomic makeup of individual patients — an important factor for many visiting the doctor. For this reason, the blood test interests many physicians.
Count me among those interested.
The company has faced criticism that it has known about the heart-attack risks associated with Avandia for years. Glaxo added a “black-box” warning to Avandia in November 2007 that says the drug can cause or exacerbate congestive heart failure. The company has also faced accusations that it attempted to intimidate scientists and doctors outside the company who raised questions about the safety of Avandia. The company has said that it didn’t try to intimidate anyone.
Pharma giant Pfizer announced today that it will be funding a Stanford University-led initiative to provide industry continuing medical eduction (CME) which will not depend upon direct corporate “influence” on the curriculum. Sounds pretty ironic, at best, and downright insidious at worst. According to Stanford , there is room for the unbound dissemination of medical didactic method free of corporate influence while allowing Pharma industry financing.
“We believe that the education of practicing physicians should be based solely on the best scientific evidence presented in a fair and balanced way,” said Jackler, professor and chair of otolaryngology. “Unfortunately what’s happened is that the partnership with industry has led CME astray, to the point where the curricula are too often biased toward business interests.
“So we set out to see if industry would be willing to partner with us to create a high-quality curriculum, under the condition that Stanford faculty would choose the topics and design the curriculum independent of the relationship with industry,” he added. “We sought not to prevent partnerships with industry, but rather to redefine it.”
Redefinition. I guess it’s all in the semantics. | LINK
Pharma has no comment on it. Congressional Democrats are wasing no time in investigating it. The concern over Pharma’s recent move to inflate drug prices on prescription branded agents is drawing scrutiny from the powerful House Ways & Means Cmte. As much as a 9 percent increase for the most widely prescribed medications today has apparently been implemented. The Dept. of Health & Human Svcs. has also been asked to investigate. Against the backdrop of strident efforts to reform what are seen as excessive cost drivers in the healthcare marketplace, the price increases set by Pharma represent an easy target by lawmakers.
Alleging the gamut of rationale to include everything from pre-emptive revenue enhancement ahead of reform[1] to outright price gouging, lawmakers have also asked the General Accounting Office to come up with a proposal to continually monitor Pharma for such increases for the benefit of Congress. If Democrats’ concerns pan out, it would question Pharma’s motives, especially in light of the possible benefits to the industry as the result of reform. | LINK
How can a drug’s study results involving just over 200 or so participants shake up healthcare policy? If the name of that drug is Zetia, there’s already enough political baggage that is making that happen. Statements like the following from the study’s lead investigator are pretty definitive — and to Merck, pretty damning:
“The results are very clear,” says lead investigator Allen Taylor of the Medstar Research Institute. “Niacin was superior.”
You read right. Niacin, a commonly used (and cheap) B vitamin did a significantly better job of shrinking artery plaque than the billion-dollar blockbuster ezetimibe (Zetia), also a component in the top-selling agent, Vytorin. Critics may claim — and rightly so — that this trial, involving just 208 people — is just too small to have a significant impact on clinicians who prescribe Zetia and/or Vytorin to treat this country’s number one killer — heart disease. However, there is no denying that the impact beyond this result is huge and is based upon the fact that ezetimibe’s lackluster trial data was the third iteration in two years[1] to challenge the effectiveness of one of the world’s most popular heart drugs, with $21B in sales since it was introduced in 2003.
The result was so pronounced that the study was stopped in 14 months. Although the use of ezetimibe, an expensive branded drug not automatically covered on all drug plans, was not found to be superior to the much, much insanely cheaper niacin, it does represent a niche for doctors treating patients who have yet to reach cholesterol goals and who cannot tolerate some of the more bothersome adverse effects[2] of niacin. Of course, Merck “stands by” Zetia, but they have to be preparing themselves for the inevitable onslaught of patient concern of paying in a major way for a drug found to be no better than a lowly B vitamin in the treatment and secondary prevention of heart disease. | LINK
If you’re a pharma company that thrives on innovation (and, really, are there any which don’t?), and you’ve got to get product out; you have two things working against you: an economy which won’t begin to see its brightest days until year or so from now, and huge stakes on whatever decision lawmakers fashion out of the health reform debate. Although high powered lobbyists for the drug industry probably have your back, you’re still a little reticent about unleashing a new agent.
Then again, you could just throw caution to the wind and release a drug, make news at the same time, and pray for immediate profits to please shareholders so that they can keep the investments coming based upon a portfolio which aches to show any improvement over the previous quarter’s.
That’s the route Schering-Plough has taken by releasing Saphris (asenapine), a new agent in the treatment of bipolar disorder and schizophrenia. It’s joining an already crowded field of other drugs in its class to treat these disorders. Time will tell if it makes a difference in patients’ lives, but for its pharma company, it better be sooner — as its spin has already started.
“Basically these drugs have tended to fall into two baskets,” Robert Consalvo, director of global product communications and advocacy relations for Schering-Plough, says. One group is potent but has side effects such as weight gain or blood sugar issues, while others are better tolerated but not as effective, Consalvo explains. “We see asenapine combining the potency with that acceptable metabolic profile.”
[...]
If that’s the case, then asenapine would make a contribution to the field, notes Jeffrey Lieberman, MD, the Lawrence E. Kolb Chairman of Psychiatry at Columbia University’s College of Physicians and Surgeons and director of the New York State Psychiatric Institute. “But the data that have emerged so far haven’t shown that,” he says. “The studies haven’t shown that it provides any unique therapeutic advantage. The main contribution is that clinicians and patients will have yet another choice.”
Choice. It’s what happens when innovation isn’t disrupted. How will it continue to be financed? | 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.
RT @markraganceo: 14 ways social media may change doctors' visits http://t.co/CXpyRFRV #hcsm #physicians
FCC proposes allocation of spectrum for Medical Body Area Networks (for vote on 5/24) http://t.co/bAiyRaRk #mHealth
#eHealth News: These Stocks Will Thrive, Obamacare or Not http://t.co/6uXhFARZ http://t.co/b7p882rP
#pharma news: Playoff Trifecta Means Windfall Curbed by L.A. Traffic http://t.co/voOlghpt
RT @Ziggy_Daddy: Hunger Growing Problem Among Seniors | Crooks & Liars http://t.co/FRRGv4d4 But hey #GOP, let's turn #Medicare into a voucher system, right?
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.
