Health Business Blog

Cook Medical makes the Surgisis ES graft, used in surgical treatment of Peyronie’s disease, aka penile curvature. The company has posted a new patient and physician information website, and is attempting to introduce social networking into the mix. It’s a delicate subject to say the least. The problem is usually caused by trauma during sexual intercourse, and the resulting penile curvature can be painful for both the man and his partner. It can lead to inability to have an erection, too.

The website is presented very professionally and carefully. There’s none of the pharma-style, “Ask your doctor if Surgisis ES is right for you,” although the patient is certainly led in that direction, if subtly.

The interesting aspect of the site is the Peyronie’s Q&A Forum, which is billed as a social networking tool for patients, partners, physicians and others. So far there is really nothing posted and I wonder whether that will change over time. I have a difficult time understanding how this is going to work without some serious moderation and encouragement from Cook and others. There will have to be enough added value to make it worthwhile to participate in such a forum on a manufacturer’s site. There is already a Peyronie’s Disease Society Forum that appears to be quite active. It’s a private forum so I don’t know whether Cook is already active there. They may find that a productive place to participate, assuming they are allowed to do so.

I can’t really comment on whether the physician forum is likely to succeed, although it will likely be an uphill battle.

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Ever notice that medical devices are tested on non-Medicare populations and then paid for mostly by Medicare? Dr. Rita F. Redberg did. See (Medicare coverage decisions often based on trials in irrelevant populations)

“I was appointed to the [Medicare Evidence Development and Coverage Advisory Committee] MedCAC in 2002, and my first meeting was called because Guidant had requested expansion of defibrillator coverage in the Medicare population,” co-author Dr. Rita F. Redberg told Reuters Health. “In reviewing the technology assessment, it was obvious that the data were based on a population that was different than the population we were being asked if defibrillators would provide benefit for.”

“It was difficult to make that extrapolation, ‘how would the Medicare population do based on a study in middle-aged healthy men?’” she added. “It made me think that this was not an isolated incident.”

Sure enough, when Redberg and co-author Sanket S. Shruva looked at assessment of cardiovascular technologies between 1998 and 2006 they found that the hunch was true and their study (Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions) was published in The Archives of Internal Medicine published  on January 28, 2008.

The clinical trial participants tended to be about 10 years younger (70.8 v. 60.1) and much more likely to be male (75% v. 44%) than the Medicare population.

My understanding is that the vast majority of these devices are used in the Medicare population, so this is a legitimate point. Still, it would be a shame if the impact of this report were to require companies to do more or larger clinical trials, since it would raise development costs and keep some products off the market.

I’m sure it’s not easy, but it would be great to find a reliable way to extrapolate from typical study participants to Medicare members –or real world users of devices overall. I know that this is already done to some extent through the use of patient registries and databases such as ADHERE.

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IcYou.com has produced brief videos profiling each Presidential candidate’s positions on health care. They’re worth a look before Super Tuesday:

• Hillary Clinton — Is her prior attempt at health care reform a help or hindrance?
• Barack Obama — Not a mandate man
• John McCain — Who dares to mention that costs are a problem
• Mitt Romney — Proud to have implemented a mandate?
• Mike Huckabee –A big believer in prevention over intervention

I haven’t bothered to comment on these plans because I think they’re mostly posturing. Once we get to the general election I’ll offer my views.

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The latest edition of the Cavalcade of Risk is up at The Digerati Life. My piece on CT scan radiation dangers is featured.

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Just spreading the word about a scam email I received. See the Bloptimization blog for an explanation and don’t be taken in. Here’s how it started:

From: liza

> Date: Tue, 29 Jan 2008 17:03:21 +0800
> To: {Me}
> Subject: Domain name of mppllc (TO CEO)
>
>
> Dear CEO,
> We are the domain name registration organization in Asia, deal with the
> domain name registration and dispute internationally. Now we have
> something important need to confirm with your company.
> On the Jan 28, 2008, we received an application formally. One company
> named “Mic-firstone International Holdings Ltd ” wanted to register
> following
> Domain names:
> mppllc.cn
> mppllc.com.cn
> mppllc.net.cn
> mppllc.org.cn
> mppllc.hk
> mppllc.cc
> mppllc.tw
> mppllc.mobi
> mppllc.asia
> Internet brand keyword:
>
> mppllc
>
> through our body.
>
> After our initial examination, we found that the keywords and domain names
> applied for registration are as same as your company’s name and trademark.
> We don’t know whether you have any relation with them. These days we are
> dealing with it. Now we have not finished the registration of
> Mic-firstone International Holdings Ltd yet, in order to deal with this
> issue better, Please contact us by telephone or email as soon as possible.
>
> Best Regards,
> Liza Ding
> _______________________________
>
> Asia Domain Name Registration Limited
> Tel:00852 3059 3057
> Fax:00852 3059 3080
> Email:Liza@asiadns.net.cn
> Web:www.asiadnr.net  www.domaininasia.org

I emailed them back, confirming ownership of mppllc.com and received this reply:

Dear  Sir,
>
> We understand your meaning, and it is our responsibility to inform you. We
> knew you have registered the domain name “mppllc.com” and own the
> intellectual property, this is why we informed you. But now Mic-firstone
> company do not want to register your trademark or domain name
> “mppllc.com”, they wanted to apply for other domain names and keyword you
> have not registered yet. Because domain name takes open registration, this
> is international domain name registration principle. So Mic-firstone
> company or every other third party all has right to register it. As a
> domain name registrar, we have no right to dispute their application. So
> required by our government to inform your company to protect your
> interest.
>
> As the owner of “mppllc.com”, you will get the priority to register these
> domain names and keyword. Of course, each company has their own idea. If
> you don’t think their application will affect your company, you can give
> up, we will finish their registration. But if you think their registration
> will confuse your clients and harm your profits, we can send a dispute
> application form to you and help you register these within dispute period.
> This is the only way to prevent domain name grab. Hope get your decision
> ASAP, so that we can handle the next step.
>
>
> Best Regards,
> Liza Ding
> ____________________________

I asked them to send the “dispute application form,” and got this in reply:

Dear  David,

Attached dispute application form, pls check. We just could help you to dispute these domain name when we get you application form .pls note, all of the registration procedure are all in the application form, pls progress our work follow it. So please fill in and return to us ASAP.Thank’s

Best Regards,
Liza Ding
____________________________

As you can probably guess, the “Domain name&Internet brand keyword Disputed Applicication form” is not a dispute form at all, but an order form, with exorbitant rates to register domains. Here’s the price list:

Single registration fee:
(.cn/.com.cn/.net.cn/.org.cn)Domain name:160USD/ 5 Years Per Name
(.hk/.tw)  Domain name:405USD/ 5 Years Per Name
(.mobi) Domain name:320USD/ 5 Years Per Name
(.cc) Domain name:340USD/ 5 Years Per Name
(.asia)  Domain name:840USD/ 5 Years Per Name
.Internet brand keyword: 705EUR/ 5 Years Per Name

And of course that gave it away right there.

I don’t think these scammers will score too many hits because they are just too greedy. They’d probably make more money by charging a “dispute resolution processing fee” or some other kind of innocuous service charge rather than going for the big score.

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According to the UK’s Daily Telegraph (Don’t treat the old and unhealthy, say doctors)

Smokers, heavy drinkers, the obese and the elderly should be barred from receiving some operations, according to doctors, with most saying the health service cannot afford to provide free care to everyone…

One in three said that elderly patients should not be given free treatment if it were unlikely to do them good for long. Half thought that smokers should be denied a heart bypass, while a quarter believed that the obese should be denied hip replacements…

Gordon Brown promised this month that a new NHS constitution would set out people’s “responsibilities” as well as their rights, a move interpreted as meaning restric­tions on patients who bring health problems on themselves. The only sanction threatened so far, however, is to send patients to the bottom of the waiting list if they miss appointments.

The survey found that medical professionals wanted to go much further in denying care to patients who do not look after their bodies.

Ninety-four per cent said that an alcoholic who refused to stop drinking should not be allowed a liver transplant, while one in five said taxpayers should not pay for “social abortions” and fertility treatment.

Paul Mason, a GP in Portland, Dorset, said there were good clinical reasons for denying surgery to some patients. “The issue is: how much responsibility do people take for their health?” he said.

Even if I am generally sympathetic such thinking, I find such attitudes among physicians troubling, for multiple reasons:

• I’m sure such views are being put into practice even if it’s not official policy
• Doctors can’t be counted on to judge whether people are too old for treatment. I saw it happen with a relative, who was judged “too old” for chemo by his oncologist, even though that’s not well supported by the evidence. The old are often discriminated against in treatment decisions
• Who’s going to make these judgments about whether someone’s on the right side of the line or not?

PS: just saw this article in the Washington Post (Weighty Assumptions) about the tendency of some physicians to treat overweight people unfairly:

Overweight and obese patients have long complained that doctors treat them insensitively and are too quick to attribute health problems to their weight. But their claims of bias were often met with skepticism — until recently. Now research from such academic powerhouses as Yale University and the University of Pennsylvania is adding to evidence that the problem may be real and may affect patients’ quality of care. And actions by the giant health maintenance organization Kaiser Permanente show the medical establishment is beginning to respond.

Two studies in the journal Obesity Research in 2003 found that many physicians harbor negative attitudes toward fat people: A University of Pennsylvania study of 620 primary care physicians found that more than half reported viewing obese patients as “awkward,” “unattractive,” “ugly” and “noncompliant”; a Yale study reported that health professionals strongly associated being overweight with being “lazy” and “stupid.”

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Emergiblog hosts this week’s Grand Rounds.

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From the New York Times (In Pitches to Doctors, Promise of Big Payday)

Using e-mail solicitations that promise high pay, US HIFU (pronounced you es HIGH-foo) is trying to build and train a network of American urologists for its offshore prostate cancer treatments. “The opportunity before F.D.A. approval is very lucrative,” said one message sent by the company…

But some doctors worry that the money could sway doctors to recommend the treatment, even though it is not approved by the Food and Drug Administration…

According to the solicitations, a doctor providing the company’s treatments can receive up to $7,500, which the company says is five times what doctors earn in the United States for performing other types of prostate cancer procedures…

The chairman of the company, Stephen R. Puckett Sr., said that the company believed that financial incentives did not influence medical judgment. About 30 American medical doctors are fully certified to use the equipment, the company says.

I expect that the FDA will determine that this practice is abusive and find a way to crack down. It’s almost funny for a company to call the opportunity “lucrative” and then have the chairman say financial incentives don’t matter.

US HIFU appears to be pursuing an interim strategy to generate revenue from US patients prior to approval in the US, after which it will presumably stop the practice. (At least this is what I infer from the article.) The idea of sending US doctors abroad is unusual and I don’t know of many companies like this.

But this case has broader implications for medical tourism, which might not be obvious at first glance:

Consider the case of a US-based medical device company that decides not to apply for US approval at all, but rather gains approval in one or more medical tourism destinations where approval procedures may be less stringent. That company then encourages –directly or indirectly– US patients to journey abroad for a procedure involving the device, reaping the revenue from US patients who then return to the US. This could happen to J&J for example, which has announced a new, low end line of medical devices for the Indian market. It seems likely that US patients will end up with “Indian” J&J devices, which will cause some problems when those patients need follow-up in the US. Is J&J going to provide information or support in the US for products that aren’t approved here? It won’t make them too popular with the FDA if they do.

It will be exciting to see where this takes us.

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See Diabetes Mine for a first-person account of a Person with Diabetes (PwD) who is also a Pharmaceutical Sales Representative (PSR). Here’s a taste:

As a person with Type 1 insulin-dependent diabetes, I am fiercely independent. I refuse to let my disease control me and strive to control it. I am a “good” diabetic, checking myself an average of 10 times per day. With my career comes the blessing of knowledge exposure and the expectation to own it…

The basis for my job is to bring information to the physician, to be a resource to your doctor. I am also supposed to partner with your doctor’s staff, all in the name of making it better for you as a patient. We bring samples and supplies for the physicians so that they will get the clinical experience, and thereby expertise with our medications in addition to giving the patients a “leg up” when having to start a new medication. While there are many reps out there that seem to monopolize your doctor’s time, we are not all alike. I sympathize with you for what it may in fact appear to be or for that matter actually be somebody who is taking your time up with the doc and making the doctor run late. Just remember: some may do that, but there are others like me that are respectful of you as the patient, the staff and physician, because I know just what it’s like to be you and I respect that. I’m different because I hold myself to a higher standard. I am empowered by my job in pharmaceuticals because the information is with me each and every day. I want each diabetic patient to own their disease with the same determination that I have. I want each of you to be successful in the management of your disease. Bottom line is that I expect a lot from myself as the pharmaceutical rep because I walk in your shoes, and you as the patient should too.

It’s an interesting presumption that a PSR is able to control the amount of time they spend with doctors and disrupt physicians’ schedules. If your doctor’s like that you might want to find someone else! At a bare minimum take it as a cue to make sure you spend the time with the doctor that you need to get your questions answered.

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I spoke recently with Dr. Vincent Carrasco, Chief Medical Officer of RadarFind, a hospital asset and patient tracking company in North Carolina. RadarFind’s real time location system allows hospital administrators to monitor the location and status of patients and equipment. Hospitals generate a return on investment by keeping better track of equipment, reducing the need to buy extra assets.

RadarFind is also useful for infection control initiatives. The equipment status tags broadcast information about where the equipment is and whether the equipment is clean, dirty or in use. Combining that information with patient location and status makes tracking down the source of an infection a lot easier.

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Technical note: This podcast was recorded using my least-preferred method: a conference bridge and call-recording service. The audio quality is low on both ends of the call and so is the sound level. Unfortunately I’ve been having trouble lately with Skype, which lets me use a studio-quality mic on my end. You’ll be able to hear the difference by comparing this podcast’s intro (which I recorded with my good mic) and the rest of the podcast.

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