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Karen Ventii is a science/ medical writer and blogger—Science to Life blog—based in Atlanta GA. She is currently working on her Ph.D. in the field of cancer biochemistry at Emory University. Karen has posted some really cool stuff on her blog. I thought it would be fun to bring a younger perspective to my blog (especially on topics that I know very little about). So, let me know what you think about the following post!

Google Health, the latest service from Google, was launched about three weeks ago as a beta version. Online personal health services have been around for a while (including Revolution Health and Microsoft's HealthVault) but here's what Google says is different about theirs:

1. Portability: Through Google Health, you will be able to have access and control over your health data from anywhere. People who travel will be able to move health data between their various health providers seamlessly and with total control.

2. Ease of use: Clean, easy-to-use user experience that makes managing your health information straightforward and easy.

3. Partnerships: Due to the integration of third-party services you'll be able to automatically import information such as your doctors' records, your prescription history, and your test results into Google Health in order to easily access and control your data. In the future you will be able to do things like schedule appointments and refill prescriptions.

4. Security: Google Health will protect the privacy of your health information by giving you complete control over your data.

I was particularly curious about the security issue. Google Health is not regulated by HIPAA (Health Insurance Portability and Accountability Act)-the national policy on health information privacy-because Google does not provide health care services.

In an Associated Press article, Pam Dixon, executive director of the World Privacy Forum, said that by transferring records to an external service, patients could unwittingly make it easier for the government, a legal adversary or a marketing concern to obtain private information.

Google has provided a chart describing how their data confidentiality practices compare to those mandated by HIPAA. I am no expert on health information security but based on this chart, Google's policies appear fairly similar to HIPAA's.

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Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the FDA to the punch and issued draft guidance for follow-on biologics known in Canada as subsequent entry biologics. The Canadian regulatory agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway.

If approved, a subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly- available safety and efficacy data. Product interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A meeting to review the draft document is scheduled for May. The proposed Canadian legislation is very similar to that adopted by the European Union for biosimilar products (what they are called in Europe). Not surprisingly the recently proposed US legislation is markedly different than the Canadian and European legislation. Go figure!

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Health care spending in the United States grew 6.7 percent in 2006 to $2.1 trillion, or $7,026 per person. This represents a slight increase over the 6.5 percent rate in 2005 (which was the slowest growth since 1999). Health spending accounted for 16 percent of US gross domestic product in 2006, outpacing overall nominal GDP growth by 0.6 percent. However, total health care spending in the US is not the real story here.

The federal government reported that the new Medicare drug benefit called Part D, which was implemented in early 2006, contributed to an 18.7 percent increase in Medicare spending that year, the fastest rate of growth since 1981 and double the rise in 2005.  In 2006, Medicare spending rose to $401.3 billion, up from $338.0 billion a year earlier, according to the government’s annual health spending report.

The impact on funding sources that paid for prescription drug benefits varied. The public share of spending (federal and state)  increased from 28 percent in 2005 to 34 percent in 2006, while funding from private sources (insurers) fell from 72 percent to 66 percent.  The shift in funding was most dramatic for Medicare and Medicaid. Medicare’s share of total retail prescription drug spending surged from just 2 percent in 2005 to 18 percent in 2006, following Part D implementation. Meanwhile, Medicaid’s share fell from 19 percent to 9 percent.

At present, the US government cannot negotiate prescription drug pricing with drug companies that produce the medications–only drug distributors and third party insurers can do that! As the baby boomer retirement continues, the amount of government spending on prescriptions drugs will increase exponentially and ultimately cause healthcare costs in this country to explode. In my opinion there are two options: impose price controls on prescription drugs or provide all US citizens with a national healthcare system that allows the government to negotiate drug pricing directly with drug manufacturers. And for those of you who think national healthcare is a fantasy–over 60% of all healthcare claims in the US are currently handled and paid by Medicare–a federally finaced and run government healthcare system!  We are closer to a national health insurance program than you think!

Until next time...

Good Luck and Good Job Hunting!!!!!!

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Fellow blogger, Jacob Goldstein, over at the WSJ Health Blog posted a story today about a prominent hypertension researcher who was approached by a medical communications agency about  putting her name on an abstract (she did not participate in the research) that was being prepared by the agency for a pharmaceutical client. According to the Health Blog, the researcher was so outraged by the offer that she decided to go public about the alleged “ghost writing” incident. I have no doubt that the story is accurate.  That said,  I think that a comment posted to WSJ’s blog about the story sums it all up nicely:

 “So, this is some new revelation for the WSJ? There are plenty of studies in the medical literature which have been ghost written by an industry-sponsored medical writer, that was then submitted under the name of a highly-recognizable leader in the field–always at a steep price”.

As much as I hate to admit it, the person who posted the comment is right--sort of. Although ghost writing was commonplace in the medical communications industry as recently as a few years ago, the practice is no longer tolerated at most medcom agencies, and, perhaps more importantly, by the would-be authors whose names ultimately appear on the publications. That said, medcom agencies and their clients must remain vigilant in their attempts to eradicate ghost writing entirely so that all medical communications are written (and published) in the most scientifically-sound and ethical manner.

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