Again, in the last week I have come across a few reports and news items which are worth passing on. These include first:
Senate passes sweeping drug-safety bill
The FDA's powers and staff would be enlarged to more quickly scan the marketplace for risky medications.
By Ricardo Alonso-Zaldivar
Times Staff Writer
May 10, 2007
WASHINGTON — The Senate overwhelmingly approved a landmark drug safety bill Wednesday, doubling the number of government scientists assigned to ferret out risky side effects in medicines already on the market.
The measure also would create a computerized network to scan medical insurance and pharmacy records for signs of trouble with new drugs, and significantly expand the Food and Drug Administration's power to require drug makers to reduce risks.
"This is unquestionably the biggest change in the FDA's regulatory authority in a very long time," former agency Commissioner Mark B. McClellan said. "It is really a new era for the FDA that will start after this law is implemented."
The Senate bill was drafted in response to highly publicized safety lapses — including the belated withdrawals of the painkiller Vioxx and the diabetes drug Rezulin, as well as the FDA's tardy warning about the suicide risks of antidepressants.
Rezulin, which was found to cause liver failure, was pulled from the U.S. market after being cited in more than 500 deaths. Vioxx was found to increase the risk of heart attacks.
David Willman, a veteran reporter in The Times' Washington Bureau, won a Pulitzer Prize in 2001 for his investigation into FDA approval of seven drugs, including Rezulin. The Times investigation found that the FDA had given the drug fast-track approval despite concerns within the agency over its safety.
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Key Points of Legislation
Drug safety
Some highlights of the prescription drug safety bill passed by the Senate:
• Creates a computerized system to monitor potential problems with new drugs.
• Gives the Food and Drug Administration stronger legal powers to require follow-up safety studies and stronger warnings for medications already on the market.
• Provides significant increases in funding and staff for the FDA drug safety office.
• Expands public disclosure of clinical trials and their results.
• Requires the FDA to release dissenting opinions of agency scientists.
• Imposes stricter conflict-of-interest rules for the FDA's outside advisors.
This is really a major set of changes for the US Food and Drug Administration to try and improve drug safety and drug side effect monitoring. Of course it is only through more effective use of Health IT that such improved outcomes and safety can be achieved.
In Australia we will soon have a new regulator. The new regulator will be the Australia New Zealand Therapeutic Products Authority (ANZTPA), and will replace Australia's TGA and NZ's Medsafe in evaluating the risks and benefits of prescription and non-prescription medicines, blood products and medical devices. This planned new regulatory agency should look very hard at what is happening in the US in this area.
Second we have:
http://www.e-health-insider.com/comment_and_analysis/index.cfm?ID=212
Deal or no deal?
| 10 May 2007 |
With a full blown bid for iSoft by Australia's IBA Healthcare now appearing imminent, a number of pressing questions are raised by the potential deal.
Not least, is whether the acquisition of the principal clinical software supplier to the NHS IT programme by a smaller Australian rival would best serve the interests of the NHS?
First, it's worth remembering that iSoft is not spoilt for choice of suitors. IBA Health is the only potential bidder to yet identify itself publicly. Press reports suggest that the likes of health IT giant McKesson withdrew after taking an initial look.
After a suffering a litany of body blows in the past 18 months – most notably mounting delays in delivering the key Lorenzo product, ongoing regulatory and financial investigations and being forced to restate its accounts – iSoft has seen its stock market valuation plummet, together with City confidence.
Since taking over at the helm last summer executive chairman, John Weston, has managed to bring stability and cut costs sufficiently to ensure the company remains a going concern until November. But it must deliver the next generation Lorenzo product to its key LSP customer, Computer Sciences Corporation, and has a pressing requirement to secure long-term funding or find a buyer.
The key question for NHS customers remains whether IBA will be able to deliver Lorenzo any quicker or more effectively than iSoft or whether it would instead offer alternative products – potentially iSoft legacy products. The current stated delivery deadline for Lorenzo is early 2008; would an IBA acquisition make this more or less likely to happen?
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It will be fascinating to see how this plays out. It is well worth while to read the whole article for background. My views on this proposed takeover are to be found here:
http://aushealthit.blogspot.com/2007/02/some-gratuitous-advice-for-iba-health.html
To date I have had no reason to change my views.
Third we have:
http://www.healthleadersmedia.com/view_feature.cfm?content_id=89387
Avoiding the Iceberg: Technology's Affect on Operations
Cynthia Centerbar, for HealthLeaders News, May. 10, 2007
Over the past 20 years, healthcare information technology has improved dramatically (remember when a 14K speed modem was considered fast?). Likewise, healthcare managers have become more sophisticated technologically-speaking. There is no shortage of meticulous IT implementation plans replete with specific objectives, critical success factors and detailed timelines. However, more often than not these plans neglect a crucial element that can determine whether the entire project fails or succeeds: The effect of the technology on operations.
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This article is well worth a read and makes the vital point that the impact of technology on those at the workplace is a very important aspect of health IT technology implementation.
Fourth we have:
http://www.fcg.com/Research/FCGNewsletters-HealthcareIndustryNewsSummary.aspx
Healthcare Industry News Summary
April 2007
This News Summary contains synopses of, and commentary on, health-related articles that have been published in the industry and popular press. The Summary is posted by FCG to this website monthly to help you stay abreast of industry issues and trends. The Summary is not intended to be a comprehensive review of these publications, but it will highlight innovations, advances in the state of the art or practice, interesting facts, and "scuttlebutt" about the industry that will help you keep up with what is happening. The information has been sorted into categories to assist you in identifying information that is relevant to your interests.
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This monthly newsletter from the First Consulting Group in the USA – which is a major Health Consulting firm with a very significant interest in Health IT – typically extends to 30+ pages of very useful summaries on topic of interest to readers of this blog. I strongly recommend those interested sign up for the monthly alert.
Last we have:
Privacy concerns over Government net plans
Adam Turner
May 8, 2007
Next
Privacy advocates fear the introduction of a single-user name and password for accessing all online government services has the potential to become a digital national ID card.
Today's Federal Budget allocates $42 million to create a single sign-on service as part of the Australian Government Online Service Point. To be built at australia.gov.au, the service will enable Australians to carry out transactions with multiple government agencies, and move between government websites, without the need to reconfirm their identity.
In addition, australia.gov.au will use "smart forms" to automatically draw a user's details from various government departments - such as inserting Medicare details into electronic tax forms. The site will also offer a National Government Service Directory and a change of address service to eliminate the need for users to notify multiple government departments when they move house.
Around 500,000 people currently visit the site every month and 20 government agencies use australia.gov.au to provide search services for their own websites. From next year, users will have the option to create a single sign-on account.
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This particular announcement may have not attracted your attention but, at first look, this seems to be yet another identity management system which has the potential to create yet another data-base of the Australian citizenry. The list of these demographic databases existing or planned in the federal public sector now seems to include the Access Card Database, the various Medicare Australia demographic databases, the Document Verification System database, the NEHTA IHI and now this current proposal.
One really wonders why we can’t develop a co-ordinated national approach to electronic individual identity management.
More next week.
David.
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