DOCTOR PUNDIT » Food & Drug Administration

Report: FDA Pharma Approval Process Undermines Patient Access to Timely Healthcare

Michael Douglas, MD, MBA — Wed, 28 Jul 2010 15:58:46 +0000

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.

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FDA Rejects Plan to Increase Controls on Opioid Prescribing

Michael Douglas, MD, MBA — Sat, 24 Jul 2010 13:55:49 +0000

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

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FDA Tells Pharma Co. to Halt Recruitment for Its Own Safety Trial

Michael Douglas, MD, MBA — Thu, 22 Jul 2010 14:55:33 +0000

Embattled pharma company GSK may be celebrating the continued availability of its once-blockbuster drug Avandia on the market, but it’s bemoaning the fact that the FDA is putting the breaks (halting recruitment) on a safety trial it has begun initiating in an effort to restore positive PR for its troubled drug. As part of its 20-12 ruling to keep the drug on the pharma market, the FDA is also requiring the IOM to investigate the ethics surrounding GSK’s commission of the trial.The study, though not officially canceled, is suspended while the FDA continues to soak in the data and come to its own definitive conclusions regarding the safety of Avandia. | LINK

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FDA: Avandia Stays on Market

Michael Douglas, MD, MBA — Wed, 14 Jul 2010 21:32:12 +0000

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.

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FDA Discussions on Avandia Enter 2nd Day

Michael Douglas, MD, MBA — Wed, 14 Jul 2010 11:32:26 +0000

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.

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Report: Pharma Company Covered Up Known Cardiovascular Risks of Drug

Michael Douglas, MD, MBA — Tue, 13 Jul 2010 14:56:46 +0000

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

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FDA to Decide Fate of Diabetes Drug This Week

Michael Douglas, MD, MBA — Mon, 12 Jul 2010 00:32:44 +0000

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

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.

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Diabetes Drug Once Again under Scrutiny

Michael Douglas, MD, MBA — Tue, 29 Jun 2010 13:12:19 +0000

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

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.

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Tuesday Newswire: MN Nurses Overwhelmingly Approve Move to Strike & More

Michael Douglas, MD, MBA — Tue, 22 Jun 2010 13:17:45 +0000

It’s on. The mega union only needed 66%. They got over 80% ‘yea’. [LINK]
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Hospital executives who have worked with Dr. Berwick describe him as a visionary, inspiring leader. [..] Republicans are using the nomination to revive their arguments against the new health care law, which they see as a potent issue in this fall’s elections, and Dr. Berwick has given them plenty of ammunition. In two decades as a professor of health policy and as a prolific writer, he has spoken of the need to ration health care and cap spending and has confessed to a love affair with the British health care system.

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A Disturbing Pattern of Medicaid Fraud Rapidly Unfolds in Plain Sight

Michael Douglas, MD, MBA — Thu, 17 Jun 2010 13:25:28 +0000

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

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