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

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

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. [↩]

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

1. Physician-critics have said the overall rate of cardiovascular problems among patients in the trial was suspiciously low. Many Avandia patients took statins — 10 percent more than the non-Avandia users — and those cholesterol-fighters are known to cut heart attack risk. Also, they say, a relatively high level of patients dropped out of the trial entirely, which could have compromised the results. [↩]

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

Prescription Psychotropic Infographic via GOOD

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

• Vanderbilt University (my undergrad alma mater) has announced that it has access to a special blood test that can predict a patient’s risk for heart disease. Using genomic factors, along with the patient’s age, history of stable chest pain, and gender — the assay (dubbed Corus CAD) offers a non-invasive alternative in stratifying coronary disease risk.
  

  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.

• On a more dour note, there is renewed interest in the recall of rosiglitazone (Avandia), the Glaxo drug with known associations in causing cardiac disease and risk of death; confidential studies via officials in the FDA are recommending the drug’s withdrawal from the market, potentially leaving Pfizer’s pioglitazone (Actos) as the only market alternative in this class to treat diabetes mellitus, type 2.
  

  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

1. Drugmakers have recently backed Democrats’ plan to overhaul the U.S. healthcare system, making a deal with some senators and the White House to provide around $80 billion in savings and rebates over 10 years. Some lawmakers are concerned price increases could be method to recoup expected loss of profit as the result of final reform bill. [↩]