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Check out the latest edition of Grand Rounds at A Chronic Dose.

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In his Software Advice blog (The Double Standard for Web-Based EMRs), Houston Neal argues that some physicians are unreasonably wary of using web-based electronic medical records:

Why are some physicians still fearful of web-based electronic medical records (EMRs) when most of them are comfortable using web banking and e-commerce sites?

Many physicians allow all of their personal financial information to be transmitted over the Internet – including actionable credit card data – but fear using the same methods for managing their patient records.

It’s not irrational to be worried about security breaches on the web. But what is the likelihood of compromising patient data through a web-based EMR? Is it a higher or lower risk than web banking or e-commerce? And who would try to hack that information anyways?

Neal suggests that the data on privacy and security violations don’t support the notion that web-based EMRs are dangerous compared with traditional paper-based systems that fall into the wrong hands when they’re thrown into the dumpster, faxed to the wrong party, or handed to the wrong patient. Neal advises physicians to review the 10 CCHIT criteria related to security and reliability and make sure their vendors are up to speed on them.

I think Houston is about right. Web-based EHRs are really not that much of a threat to security if they’re set up right.

However, medical identity theft remains a big problem. I was surprised a few months ago to learn that stolen medical information is more valuable than stolen credit cards. (See Why stolen personal health information is so valuable.) I think that’s because banks are quick to notice fraudulent card use and cancel cards, whereas insurance companies could take forever to notice someone’s medical identity being used fraudulently. This problem would exist even without web-based EHRs, however.

Thanks, Houston for an informative post.

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From the New York Times (F.D.A. Panel Votes to Ban Asthma Drugs)

A panel of federal drug experts voted on Thursday that the drugs Serevent and Foradil should be banned from use in the treatment of asthma, but the experts said that Advair and Symbicort, which together are far more popular, should continue to be used.

Advair contains Serevent and a steroid. Symbicort contains Foradil and a steroid.

Doctors face difficult choices with children whose asthma remains uncontrolled with low-dose steroid treatment. If they increase the steroid dose, the risks include stunted growth, acne, greater vulnerability to infections and changes to skin, eyes and bone. If they add a long-acting beta agonist, the risk of death, although small, increases.

The beta agonists, by relaxing bronchial spasms, treat mild symptoms and make patients feel better immediately. Feeling better, these patients may decide against taking the steroids since steroids have few immediate benefits. Indeed, patients prescribed both drugs separately get fewer refills of the steroid than of the beta agonists. Such patients leave themselves vulnerable to severe attacks and death.

This information is hardly new. SimulConsult’s Michael Segal MD PhD has been warning about these drugs at least since his 1992 letter to the New England Journal of Medicine. His guide to asthma is essential reading.

It will be interesting to see if Obama’s proposed Comparative Effectiveness Institute or the FDA’s Sentinel Initiative tackles issues like this one. It hasn’t been in any manufacturer’s interest to study this issue and so there’s been little attention paid to it despite the warning signs.

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As I’ve written before, rapid increases in the use of medical imaging, especially CT, have led to alarming increases in radiation exposure in addition to the financial cost. This is a particular issue for kids, especially since they often receive radiation doses that are needlessly high. Initiatives such as Image Gently are doing their best to educate physicians on the need to use lower settings for kids.

However, even radiologists who know not to dose young kids with adult-strength radiation settings may not realize the need to be careful with teenagers as well. According to AuntMinnie (Smaller teens sometimes get adult-sized CT dose, study finds) teenagers often receive adult levels of radiation despite smaller body sizes.

“This discovery was unexpected and alarming, considering that more than 50% of teenage children who receive CT exams at [the Medical University of South Carolina] don’t have the body mass of a fully formed adult,” said Dr. Dobrinka Dimitrova, a radiology resident, during her scientific poster presentation…

“Above the age of 12 years, kV and mAs are standardized to fully formed adult bodies,” Dimitrova said. “Because children over the age of 12 have different growth rates, a 15-year-old girl, for example, may have a body size comparable to a 10-year-old. She may receive a lot higher dose than needed because the set parameters are for adults.”

“Some of the CT scans I’ve investigated have as much as 25 mSv of radiation dose. Two of these will put a pediatric patient into a category of high incidence of solid tumors or lymphoma. [Emphasis mine.] Radiologists need to be the gatekeepers to protect children from unnecessary and excessive radiation dose.”

This is a major issue for the medical community. Until things are sorted out parents should respectfully challenge radiologists who suggest CT scans. It may be an uncomfortable thing to do,  but your kid may thank you later.

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Vince Kuraitis has done a masterful job of crafting the latest Health Wonk Review at his e-Care Management Blog. Gotta love the Dragnet theme!

He was kind enough to squeeze in a last minute submission from me, as well.

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Merck has made a wise decision to pursue the development of generic biologic drugs. (See Merck Restructuring Puts a Focus on Generic Drugs.) Merck and its traditional big pharma rivals are suffering because they’ve failed to develop novel chemistry-based products and because their existing products face generic competition. Although the biotech sector has not been stellar, at least biotech companies are still developing and launching innovative products. Meanwhile, the generic biotech market doesn’t really exist yet (except a bit in Europe).

As the market has shifted, biotech products are taking up a higher and higher share of total drug spend. Individual biotech products can be frightfully expensive: often tens or even hundreds of thousands of dollars per year per patient. And unlike with chemistry-based drugs, there’s no relief valve of generic competition to drive prices down 30, 50, or 90 percent. The biotech industry has been around for a couple of decades now, so products are going off patent but maintaining their monopoly.

From a policymaker’s standpoint, the time would appear to be ripe for bio-generics. After all, the Hatch-Waxman Act, which created a pathway for generic drugs, led to a vibrant generic industry and affordable drug prices. Why not do the same thing with biologicals? Merck and others are banking on action from Congress that will enable a bio-generic industry to form. It’s a good bet.

But as I’ve written before (Paradox or Idiocy?), bio-generics are a bad idea. Generic versions of drugs like Zocor can be substituted directly by pharmacists. If the doctor writes “Zocor” the pharmacy can (and often is mandated to) fill the prescription with generic simvastatin instead. Generic companies sell based on price, which drives prices way down once a few companies reach the market. Generic companies just have to show their drugs are chemically the same –they don’t have to conduct clinical trials.

That’s not how it’s likely to work for bio-generics. These products will be considered “bio-similars,” not directly substitutable by pharmacists. That’s because biologics are much more complex to manufacture, and it’s very difficult to make an exact match. Companies will also have to perform some clinical trials on human patients in order to get approval. If you think about it, this is really much more similar to the traditional big pharma model than it is to the generic market. And the result will probably be like the big pharma model, too, not the generic market.

Back in the day when the pharmaceutical industry was launching new classes of drugs, every big pharma would rush to develop a “me too” product in the same class. The drugs were similar, but not directly substitutable. The statin class is a good example: Mevacor came out first, followed by many others including Zocor, Lipitor, Lescol, Pravachol and Crestor. Companies spent serious money to persuade physicians and payers to cover these products. Each company looked for ways to position its product slightly differently to emphasize the real and imagined distinctions among the products. This included large sales forces, follow-up clinical studies, direct to consumer marketing and other big pharma activities. You can be sure prices didn’t fall as a result of all the statins reaching the market!

Merck is probably counting on developing the same model in biologics. The company plans to bring to market a competitor to Amgen’s Aranesp, but I’ll bet you they won’t position the product as “generic Aransep.” Instead they’ll emphasize subtle differences in the product to pitch it as an alternative therapy. They’ll deploy a salesforce that visits physicians and will look to expand the overall market. Maybe they’ll price the product somewhat lower than Aranesp. Then again, maybe they won’t.

If policymakers want to control the cost of biologics, there’s a much simpler and easier way. Simply regulate the price of biologics once their patents expire. That would have several advantages:

• Guaranteed lower pricing and certainty about when lower pricing will be available
• No need to subject patients to the hazards of clinical trials
• No need for FDA to stretch itself further monitoring new biologics manufacturing facilities –which are notoriously difficult to run well

It wouldn’t even be that bad for biologics companies. They’d already have earned their profits during the patented life of the product, and would retain 100 percent market share post-patent expiration. They can’t really complain about the government interfering with the free market, considering that patents are granted by the government in the first place.

The only real losers in this plan would be generic biologics companies. Since the industry doesn’t even really exist yet, now is a good time to implement my scheme.

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The job market may be tough but demand for egg donors and surrogate mothers remains firm, according to the Wall Street Journal (Ova Time: Women Line Up To Donate Eggs — for Money).

Women typically receive $3000 to $8000 for egg donation, occasionally a lot more. There’s also significant screening, physicial discomfort, lifestyle restrictions (e.g.,  no sex) and sometimes emotional pain involved, along with a risk of complications, so it’s not such a great deal. An egg donor agency in Chicago reports,

“We’re even getting men offering up their wives. It’s pretty scary.”

With supplies of egg donors and surrogate moms up, waiting has become a thing of the past for clients, which is a good thing at least.

It’s not exactly surprising that demand is holding up. After all, time is not on the side of infertile couples. A lot of the demand is apparently coming from Europe, where it’s illegal to pay donors.

The American Society of Reproductive Medicine (ASRM) frowns on compensation for egg donors above $10,000, considering it to be coercive. On the other hand, you won’t find a policy statement from ASRM discussing the moral level of compensation for Reproductive Endocrinologists, who can easily earn in the 7 figures annually.

Oh, and sorry fellas. The price for sperm donation is $100 tops.

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Check out the latest edition of Grand Rounds at SharpBrains.

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The National Business Coalition on Health (NBCH) is a coalition of employer-led coalitions that focus on “value-based purchasing” in health care. I spoke today with Andy Webber, NBCH President and CEO. We talked about value based purchasing, the future of the employer-based health care system, and his expectations for health care reform during the Obama Administration. I was slightly surprised to hear Webber say that his membership is not wavering in its enthusiasm for employer-based health care coverage and private insurers, despite the limited success in controlling costs and boosting quality.

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David Williams interviews Andy Webber of the National Business Coalition on Health Play Now | Play in Popup | Download

From The Boston Globe (Should I take an aspirin before a plane flight to avoid getting blood clots?)

No, according to new guidelines issued in June by the American College of Chest Physicians, though if you already take aspirin for general cardiovascular health, you should continue to do so while you travel.

In everyday life, aspirin helps prevent clots in arteries by keeping platelets, the major element in plaque, from building up in ones arteries.

But the type of clots triggered during long plane flights are different. They start in deep leg veins, says Dr. Michael Jaff, medical director of the vascular center at Massachusetts General Hospital.

Deep vein clots are composed predominantly of fibrin, which aspirin does not affect.

With the economy down fewer people will be taking these long flights anyway. But the article does provide a number of practical tips if you are winging it.

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