Drug Safety

FDA may get $275 million more for staff, outsourcing

Wed, 11 Jun 2008 06:59:54 -0400

The Bush administration is asking Congress for an additional $275 million for fiscal 2009 to allow the FDA to add more workers, expand programs and technology, and perhaps most interestingly, outsource some of its regulatory work. Given an earlier FDA request to expand its budget, the total added funds would come to about $404.7 million in fiscal 2009 than fiscal 2008, a 17.8 percent climb in spending. This will allow for 490 new FDA jobs. The funding request also asks Congress to expand FDA authority, notably to outsource some of its regulatory work by accrediting independent, third-party organizations to conduct voluntary inspections. These organizations would have the right to ban imports by a company if it delays, limits or denies access to agency inspectors.

To learn more about the new FDA budget (and outsourcing plans):
- read this Modern Healthcare article (reg. req.)

Related Articles:
FDA says it needs bigger budget
FDA moves to allay drug-import fears
FDA can't guarantee drug safety

Studies show problems with four big-name drugs

Tue, 29 Apr 2008 06:59:56 -0400

It looks like yet another set of popular drugs are facing allegations that they pose safety risks. Drugs named this week in unfavorable studies include Fosamax, which may create heart problems for women who take it for osteoporosis and epilepsy med Dilantin, which may put young women at higher risk of developing osteoporosis. Another study concludes that diabetes drugs Avandia and Actos double or triple the odds of non-spinal fractures, particularly among patients who took the drugs for a year or more. Particularly given other drug safety controversies still very much in the public eye, this can't be giving pharma marketers a warm and fuzzy feeling.

To find out more about the studies:
- read this FiercePharma item

Related Articles:
Merck expects $1.8B hit on Fosamax
Avandia problems erode GSK profits
Takeda touts Actos as heart attack-free
Despite safety issues, Vioxx still in demand

ALSO NOTED: WellPoint exposes patient data; ED visits go up when OR trims Medicaid rolls; and much more...

Fri, 25 Apr 2008 06:59:50 -0400

> Security pros are lambasting WellPoint, which may have inadvertently allowed Web users to access data on 130,000 of its beneficiaries. FierceHealthIT

> A new study has found that when Oregon dropped a large group of Medicaid enrollees, the state's ED traffic went up. FierceHealthFinance

> It seems that pharmaceutical companies are waaaay behind on the drug effectiveness and safety studies that they're supposed to do once the drugs are approved. Surprised? FiercePharma

> Harvard president Drew Faust argues that the government's system for funding biotech research is broken. FierceBiotech

And Finally... What's really entertaining about reading this drug ad parody is that for a minute or two, you don't realize you're being taken for a ride. (Warning: Don't be drinking or eating anything when you read the advisory for squirrels). Site

Study: Errors caused 200K+ deaths from '04 to '06

Wed, 09 Apr 2008 06:59:55 -0400

The story doesn't get any prettier the more often its told. This set of data, from the fifth annual Patient Safety in American Hospitals study, makes a point often made elsewhere--that preventable deaths are far too common. In this case, it found that from 2004 through 2006, patient safety errors resulted in 238,337 potentially preventable deaths of U.S. Medicare patients and cost the program $8.8 billion. The study, published by healthcare ratings organization HealthGrades, found that if a patient was treated by a top-performing hospital, they were on average 43 percent less likely to experience an error than patients at the worst-performing hospitals. The overall error rate was 3 percent for all Medicare patients, which is equivalent to about 1.1 million safety incidents during the three years studied.

For more data from the study:
- read this HealthDay News item

Related Articles:
HIMSS: Patient safety top reason for IT investment. Safety report
Trend: Hospitals move to cut high-alert drug errors. Safety report
AHRQ: Patient safety improving, but slowly. Safety report
Study: Healthcare quality movement stalled. Quality report

ALSO NOTED: TN Medicaid to test e-prescribing program; NIH alerts patients of stolen personal information; and much more...

Tue, 25 Mar 2008 07:59:50 -0400

> Tennessee's Medicaid program and one of its Medicaid managed care providers have announced that they plan to kick off an e-prescribing pilot program in 13 of the state's rural counties. Report

> New calls for old drug data in the U.K. have experts second-guessing big drug-safety scandals. If scientists and regulators had had access to every bit of data on Vioxx from the get-go, for instance, would heart attacks and strokes have been averted? Report

> After waiting for nearly a month, officials at the NIH alerted some 2,500 people that their names, addresses and detailed personal health information gathered from heart scans in a clinical trial were purloined when an unknown person stole a government laptop with the data on it. Report

And Finally... Looks like breakfast really is the most important meal of the day. Article

Congress poised to give more power to the FDA

Thu, 20 Sep 2007 06:59:58 -0400

The U.S. House of Representatives has approved a bill designed to give the FDA more money and more authority to monitor and enforce drug safety rules. The bill, which is expected to pass the Senate this week, has pulled off the rare trick of winning over both consumer and industry groups. Not only did the president of the Consumers Union praise the measure, pharmas generally support it, too, according to the Pharmaceutical Research and Manufacturers of America. While its main immediate impact will be to reauthorize funding for the agency, it's far more than a standard reauthorization measure, observers say.

Among other things, the comprehensive bill includes a provision that will kick up fees to pharmas and drug makers which should generate an additional $400 million for the agency. The measure would also require drug makers to publicly post the results of any clinical trials involving approved medicine, and allow the agency to force drug makers to conduct new clinical trials for already-approved medications.

To get more details on the measure:
- read this article in The New York Times

Related Articles:
Researcher challenges FDA approval process. Report
Bill giving FDA more drug safety powers could pass. Report
FDA emphasizing speed over safety? Report
FDA boosts reviews for new drugs. Report
Report faults FDA's post-marketing vigilance. Report

Study: Physicians dismiss complaints about statins

Wed, 29 Aug 2007 06:59:54 -0400

A recent study suggests physicians may be dismissing or minimizing patient complaints about possible side effects from statin drugs like Lipitor, Zocor and Crestor. University of California-San Diego researchers found physicians tended to attribute potential statin side-effects like muscle pain, memory loss and numbness in hands and feet to aging, or said the side effects could not have come from the drug. To draw this conclusion, researchers surveyed 650 patients, largely U.S. residents in their early 60s.

Researchers, who published the study results in the journal Drug Safety, said the study raises questions about drug safety, given that doctors are unlikely to file adverse event reports with the FDA if they don't attribute side effects to medications.

To learn more about the study:
- read this Kaiser Daily Health Policy Report article

Related Articles:
Bill giving FDA more drug safety powers could pass. Report
FDA emphasizing speed over safety? Report
FDA boosts reviews for new drugs. Report
Report faults FDA's post-marketing vigilance. Report

SPOTLIGHT: Outsiders should see FDA safety data

Wed, 07 Mar 2007 19:01:32 -0500

Some say that if outside researchers had access to drug safety data, disasters like the Vioxx scandal might have been avoided. At present, however, the FDA doesn't let outsiders see clinical trial data unless forced to do so. This secrecy can only do harm, suggests a new commentary in Health Affairs. Report

Physicians, hospitals not thrilled by FDA proposals

Sun, 11 Feb 2007 19:01:37 -0500

With physicians and hospitals offering only lukewarm support to proposed FDA reforms of its drug safety policy and communications with the public and providers, Congress is likely to push ahead with plans of its own to regulate the agency, experts say. Physician groups like the AMA and Medical Group Management Association said they were pleased with the FDA's plans to notify physicians more quickly about drug safety concerns, though as MGMA president noted, the FDA still has little authority to force pharmas to do post-approval research on drugs. (This is probably the point at which legislators will be jumping in.)

Ultimately, advocacy group Public Citizen summed up much of the public response, arguing that FDA's proposals were appropriate, but "generally weak," focused mostly on follow-up study, panels and the like rather than concrete action plans, said Peter Lurie, deputy director for its Health Research Group. This sets the stage for Congress to take its own shots, observers like Lurie suggest.

To get more background on the response to FDA reforms:
- read this piece from Modern Healthcare

Related Articles:
FDA boosts reviews for new drugs. Report
IOM slams FDA, calls for major reforms. Report
Report faults FDA's post-marketing vigilance. Report
FDA's Crawford charged with lying about stock. Report

Cerner to acquire Galt & Associates

Wed, 14 Jun 2006 20:01:36 -0400

This is another noteworthy deal for Cerner, which as been the subject of rumors involving the massive NHS IT project in the U.K. The Kansas City-based maker of healthcare software appears to be making good on Neal Patterson's pledge to expand into new territory with the acquisition of Galt & Associates, a maker of drug safety and clinical data management systems. The Fairfax, VA-based company has 10 employees and recorded $9.5 million in revenue last year.

- see this article from the Business Journal of Kansas City