Health Business Blog

Reuters (via Yahoo! News) has a story about the double whammy of a lung cancer diagnosis. (See Lung cancer patients fight stigma.)

“I’m sorry. You don’t have breast cancer,” the oncologist told Charmaine Atkenson.
The 48-year-old mother of two had something far worse — stage 4 lung cancer. It had spread to her spine, bursting the bone open. It was not only a sentence of death; it was a judgment.

Even though Atkenson never smoked, she felt almost ashamed. “I found that I never would even say what kind of cancer I had. Or I would always start by saying I never smoked and I never lived with a smoker,” she said in a telephone interview.

The article goes on to explain that funding for lung cancer research is much lower per patient than for breast cancer or prostate cancer, two of the top-funded variants.

This is not exactly a new story. I wrote about a very similar article three years ago. (See Research funding levels are only part of the story.) Yet it seems the advocates are still on the case as well they should be.

It’s an interesting question of equity: How should research dollars be doled out? I wouldn’t mind seeing a system that laid out a set of parameters and weights to determine funding. Certainly dollars per patient would be a metric, but there would be others, too. For example, disease severity, ability to efficiently use research dollars, economic impact of the disease, and yes, possibly even impact of lifestyle in getting the disease should be considered. I suggested in my earlier post that the lung cancer people should follow the example of the Myelin Repair Foundation in encouraging efficient use of resources and rapid progress. I still believe that.

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Earlier this month I wrote about YourMisdiagnosis.com. (See Don’t believe everything you read (about Health 2.0)). My take on it was that the site was gaining much more prominence than its measly number of posts (1 then, 3 now) merited, and that journalists writing about it must not have bothered to check out the site itself. Now Dr. Mintz is attacking the blog as a deceptive commercial site. I don’t think I’d go that far but his message to pay attention to who’s behind what you read makes sense.

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Dr. Mark Thornton, former medical officer at the FDA’s Office of Oncology Products, takes Senator Charles Grassley (R-IA) to task on the Wall Street Journal’s op-ed page. (See Grassley’s War on Cancer Patients.) Thornton is upset that Grassley is challenging the FDA’s acceptance of surrogate endpoints and accelerated approval timelines. As Thornton writes:

This kind of measurement [surrogate endpoints] – as opposed to an assessment of a drug’s impact on a patient’s overall survival – has dramatically increased the pace of cancer clinical trials. It also has won near-universal acceptance within the cancer community. The FDA does require follow-on studies to assure that a surrogate finding shows clinical benefit. But if all cancer clinical trials were required to show a survival benefit from the get-go, progress in cancer-drug development would slow to an absolute crawl.

Enter Mr. Grassley. It seems not a week goes by without him making a public accusation of evil doings within the drug industry or the FDA. Yes, Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA. But he and his staff should have kept their eyes on the ball. In the case of Avastin, the senator implied in his GAO request that something sinister occurred during the FDA’s premarket deliberations, and that surrogate endpoints were the new bogeyman. Nothing could be further from the truth…

The damage done by Mr. Grassley’s decision to make an issue of this decision cannot be understated. Having served at the FDA during the Congressional hearings over the Imclone/Martha Stewart insider trading scandal, I can attest to how an action like this GAO inquiry will resonate within the halls of FDA. An extremely cautious and protective bureaucracy will respond to such intimidation by being even more protective…

Mr. Grassley’s legacy could be thousands of additional cancer deaths.

Pretty harsh stuff, but I generally agree with Thornton. Surrogate endpoints aren’t bad, and neither are accelerated approval timelines. However Grassley isn’t totally off base. In particular, not all surrogate endpoints are actually meaningful. Sometimes they’re elevated in importance at the end of a study to salvage a drug when a primary endpoint fails. Combine a situation like that with accelerated approval and a failure to conduct post-marketing studies in a timely fashion and it’s a recipe for trouble.

It’s clear Thornton is speaking from experience when he talks about the bureaucracy becoming “even more protective.” This is really something to avoid and Grassley probably doesn’t realize the harm he’s doing here by putting a chill on the examiners.

It would be more useful if Grassley and others put pressure on FDA to accept (or even encourage!) the use of new assessment technologies, endpoints and personalized medicine in clinical development. Companies often take the path of least resistance and use old-fashioned, ill-suited tests like the Hamilton Anxiety Scale in drug development just because they’ve been used before and the FDA is accustomed to seeing them.  If Senators want to shake FDA out of its conservatism they need to draw attention to some of the hidebound practices, not inadvertently encourage their perpetuation as Grassley seems to be doing.

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Hank Stern at InsureBlog has posted an excellent Health Wonk Review, playing it straight for once!

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I was happy to see that Global HealthNet CEO Sandip Madan, a contributor to my MedTripInfo website, is now publishing in the Wall Street Journal as well. (See We Need Free Trade in Health Care). Along with Columbia University professor Jagdish Bhagwati, he presents the case for increased trade in health care services as an antidote to what ails the US system. I agree with about half of what’s printed there.

The authors use the World Trade Organization’s framework to segment health care trade into four modes:

• Mode 1: Arm’s length services that can be performed at a distance, e.g., claims processing and telemedicine
• Mode 2: US patients traveling abroad, i.e., medical tourism
• Mode 3: Creating and staffing medical facilities in other countries
• Mode 4: Medical personnel moving to where patients are

The authors argue that about half of Mode 1 savings are already being realized as claims processing and customer service have shifted abroad. They’d also like to see much more international telemedicine, and I agree with them there. The concept, which I call “virtual medical tourism” is a good one. In particular it’s worthwhile to support primary care physicians in chronic care management and for second opinions. Eventually payers will realize that consultations by foreign physicians will reduce costs, since physicians from abroad are likely to recommend the less aggressive and less costly interventions they provide at home.

Mode 2 has been discussed at length on the Health Business Blog and on MedTripInfo. It has merit, but the direct impact isn’t likely to be huge anytime soon.

Mode 3 is an interesting concept. The authors think we may see foreign-owned medical facilities open in the US, to compete with US-owned facilities on price. I don’t think that’s likely because there are too many barriers to entry and costs won’t end up being any lower. I do foresee the development of US or foreign-owned clinics that ally with overseas facilities for telemedicine and medical tourism.

Madan and Bhagwati are most enthusiastic about Mode 4:

Mode 4 concerns doctors and other medical providers going where the patients are. It offers substantial cost savings, since the earnings of foreign doctors are typically lower than those of comparable suppliers in the U.S.

But the importation of doctors is even more critical in meeting supply needs than in providing lower costs. According to the 2005 Census, the U.S. had an estimated availability of 2.4 doctors per 1,000 population (the number was 3.3 in leading developed countries tracked by the OECD).

Comprehensive coverage of the over 45 million uninsured today will require that they can access doctors and related medical personnel. An IOU that cannot be cashed in is worthless.

Massachusetts ran into this problem: Few doctors wanted (or were able, given widespread shortages in many specialties) to treat many of the patients qualifying under the program. The solution lies in allowing imports of medical personnel tied into tending to the newly insured.

There is a certain logic and attraction to this argument but I don’t completely buy it. I’m definitely in favor of free immigration of physicians (see Biting the hand that feeds you, sutures you, fills your prescription.. ) but it won’t lower costs overall. A larger supply of physicians is likely to drive more demand, making costs higher. We may have fewer doctors than some OECD countries, but we have a lot more than Singapore, where the figure is only 1.4 physicians per thousand people and there is universal access to care. Our problem here is two-fold: too much demand for health care services and reimbursement for specialty care (especially procedures) that is too high relative to primary care. If we work on those issues, through education, consumer directed health care and adjustments to reimbursement then we won’t need to boost the number of physicians.
In the meantime, primary care physicians are becoming the new lettuce pickers. (See The primary care bottleneck to health care reform.) Where’s the 21st century Cesar Chavez when we need him?

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Readers of this blog know my concerns about excessive radiation dosing from CT scans, especially for children. (See Image gently, or when the diagnosis is worse than the disease.) So I’m interested in a new resolution in the US House of Representatives that calls for a reduction of radiation dosage delivered to children. From what I can tell it’s part of the Image Gently campaign.
House Resolution 1216, introduced by Representative Sue Myrick (R-NC) reads as follows:

Supporting the efforts to reduce unnecessary radiation exposure through computed tomography scans for children, and for other purposes.

Whereas medical imaging provides valuable and often life-saving medical information for patients and their families;

Whereas there is often a need to tailor techniques used in pediatric imaging to children’s smaller bodies to avoid radiation exposures that are greater than necessary;

Whereas this is especially true regarding computed tomography (CT) scans;

Whereas nationwide there are approximately 7,000,000 CT scans performed on children each year, the number may be increasing at approximately 10 percent per year, and about half of these examinations involve children under 10 years of age;

Whereas CT is the largest contributor to medical radiation dosing in the United States;

Whereas radiation can have recognized harmful effects;

Whereas children’s body tissues are more radiosensitive, and children absorb a larger dose for a given level of radiation than adults;

Whereas there are many techniques that can be used to dramatically lessen the amount of radiation to which children are exposed during CT scans, while still enabling diagnostic quality images; and

Whereas parents can help determine whether or not their imaging provider adjusts dose techniques for children by asking if their imaging facility is accredited and technologists are credentialed: Now, therefore, be it

Resolved, That the House of Representatives–

(1) encourages radiologists, radiologic technologists, medical physicists, pediatricians, other pediatric health care providers, and parents to consider the different needs of children when it comes to radiation dosing;

(2) encourages appropriate used of computed tomography scans in children; and

(3) encourages radiation protection efforts in pediatric imaging so that children may be properly diagnosed and efficiently treated for injury and disease.

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Hope you are enjoying it! I’m taking the day off.

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I was traveling from Chicago’s Midway Airport today and had my first encounter with a new TSA system that lets passengers sort themselves into the appropriate security lane based on their experience traveling and whether they’re with their family. The coding is like on a ski slope. Green/circle lanes are for families and those needing special assistance. Blue/square lanes are for casual travelers and black/diamond lanes are for expert travelers. My colleague and I took the expert lane, which said it was designed for people who travel more than twice a month, elite status fliers, people who know the TSA 3-1-1 rules and so on. That’s us.

I’d read about these lanes before and heard that their kickoff had been surprisingly smooth, with reduced stress all around.

When we got to the front of the line we were surprised that the person in front of us was taking so long. He didn’t seem to have his act together and my colleague joked with him that this was the expert lane. He got a little defensive. He finally went through the metal detector but once his bag made it through the X-ray machine he was taken aside. The TSA agent opened his bag and pulled out a giant bottle of shampoo and a giant bottle of mouthwash. The guy must have come straight from Costco to the airport! He was acting very innocent and I really wonder what he was thinking.

Looks like they may need to open up a double black diamond lane next time.

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A May 17 article in the Economist (Quagmire to goldmine?) describes the impending entry of global pharmaceutical companies into developing world markets. Traditionally the big companies like Pfizer and GSK have avoided the third world, preferring to sell blockbuster drugs at high prices in the US, Western Europe, and Japan. Sales in poor countries have typically been low or negative margin, typified by HIV drug giveaways in Africa.

That’s changing now:

• TPG, a big US private equity group, has backed Moksha8, which licenses branded drugs from big pharma to sell to rich customers in poor countries
• GSK is reorganizing to sell into poorer countries directly
• Novartis and Merck are doing research in places like China and India, which represent a new pool of talent but also opportunities to combat diseases that are rare in the rich world

As high-end pharmaceutical products reach the market in significant numbers, supply chain security becomes a major challenge — or opportunity, depending on where you sit:

• Counterfeiting is a problem and will become a bigger one. Moksha8 customers, for example will want guarantees that they are getting the real deal
• Business models that contemplate vastly different prices among countries and even within countries will be irresistible targets for arbitragers

Companies are using different colored pills, different packaging and audits in order to keep things straight. That’s not such a robust solution. It does little to address counterfeiting and diversion is likely to occur anyway. More promising will be technologies such as package-level and even dosage-level identification and tracking, in some cases through covert means. It will be interesting to see whether these technologies catch on first in the developing world and then spread to wealthier countries.

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This is a transcript of my podcast interview with Don R. Powell, CEO of the American Institute for Preventive Medicine.

David Williams: This is David Williams, co-founder of MedPharma Partners and author of the Health Business Blog. I am at the Consumer Health World Conference in Las Vegas where I spoke today with Don Powell, PhD, President and CEO of the American Institute for Preventive Medicine, a for-profit wellness company that is celebrating its 25th year in business.

Don and I spoke about how the wellness field has evolved over time, how employers think about the benefits of wellness programs, and about the kinds of customization and integration that are required to achieve success.

Don, thanks for being here today.

Don Powell: Thank you, David. Nice to be here.

David: What is the American Institute for Preventive Medicine?

Don: It is a for-profit company celebrating its 25th anniversary this year. We work with companies, hospitals, managed care organizations, unions, and government agencies to help reduce health care costs, lower absenteeism, and improve productivity by providing a variety of health management interventions.

David: What’s the scope of services that you provide?

Don: It’s both wellness and what is referred to as “demand management,” teaching employees to become wiser health care consumers and make better decisions. The company has four major products: one, our medical self-care guides, which are books that use a flowchart format to help a consumer better understand what physical symptoms they are having and what level of care they should receive in response to those symptoms. If it’s an emergency go to the ER, otherwise if it’s something you should see the doctor for or maybe something you should simply call the doctor about or consider self care.

Secondly, we provide wellness lifestyle change programs for tobacco cessation, weight control, stress management.

Thirdly, we have a variety of health communications materials, including a health newsletter, health calendars, brochures, booklets, little care kits, even refrigerator magnets to help get the health messages out.

Lastly we do a lot of customization. We developed a self-care guide for the United States Army geared toward the issues of basic training. Another one for Blue Cross Blue Shield of Massachusetts is geared toward their most frequently used ICD9 codes; an educational piece for the CIA on health fraud; another piece on antibiotic resistance for Chrysler; so, varied types of projects of a customized nature.

David: Congratulations on celebrating your 25th anniversary. That’s quite an accomplishment. Tell me how the field has changed over that time period and in the last couple of years in particular.

Don: In some ways it’s changed a great deal. In other ways it’s kind of gone back to the way it was. Like fashion, economics, health care things follow trends. You know, what’s certainly different today is the use of the Internet, and a lot of people are seeing that as the future of health care.

I take exception to that though in that I feel that there is still a very important place for more high-touch strategies as opposed to high tech. When you look at the data on whether anybody saved any money because they put up a very elaborate e-health portal on their intranet I am not aware of any study that’s documented that, whereas we have hundreds of studies on the more traditional wellness activities, such as health fairs, health coaching, health newsletters, medical self care guides, group classes and so forth. They have all shown anywhere from a three to five to one return on investment.

David: Do employers mainly look at return on investment or do they have other motivations? How do they look at the balance and is that something that has changed as well?

Don: They say they look at return on investment, but when it comes down to it probably only about 30 percent really look at that as the reason for justifying continuation of their wellness program or even starting it.

You still see where people just think it is the right thing to do. An ounce of prevention is worth a pound of cure certainly makes sense. They are kind of up in the air as to what else can they do. With health care costs rising around 9 to 10 percent per year for the last 10 years or so employers at least look at wellness as one strategy.

They also feel it can improve morale. Employees appreciate the employer taking an interest in them, and yes, hopefully at the end of the day there will be some reduction either in absenteeism, reduced health care costs when they go back to their insurer or –what seems to be a slightly growing body of literature– improved productivity, although I think the literature on that is still rather weak.

David: I have been surprised to see recently some of the large and sophisticated companies announcing that they really do see a return on investment in wellness. I think IBM cited a number of something like $100M in annual benefit that they were getting. It was the reason that they were expanding their wellness programs to dependents. Have you seen that as a trend, or is that more of an anomaly?

Don: No, there is a return on investment that can occur. In terms of how many people will go into it with that being the expectation is where I said 30 percent or maybe as high as 40 to 50 percent. But, not everybody just looks at it as a ROI issue. We do have some very impressive studies and a number of review articles that have been published in the American Journal of Health Promotion.

A series of them by Ken Pelletier have substantiated what we’ve said for the last 25 years. We can reduce health care costs and absenteeism with wellness interventions. The key though, David, is that what is wellness? People define it in different ways. I hasten to say that wellness is not because you have a no smoking policy. Wellness is not because you offer a newsletter once a month or a health fair once a year.

Wellness is a combination of a variety of activities that work together, from health screenings to a health risk assessments to health coaching to communication materials to one-on-one counseling and so forth. These types of comprehensive programs are the ones that are showing a return on investment –not something more piecemeal in nature.

David: How much customization is required within a given employer’s population for things like different generations? I assume the Generation X or Generation Y are different from some of the older folks, the retirees. Presumably, there could even be some differences depending on location or ethnicity or other factors. Can you comment on that?

Don: Yes. Clearly, the older population wants to focus more on musculoskeletal types of issues. If you have a large African American work force there’s a greater prevalence of diabetes and hypertension. Any good vendor would look at customizing their program to the needs of the population group, but there are certain similarities that run across just about all populations. We know on average 21 percent of employees are going to smoke cigarettes. Sixty percent are going to be obese. Six to eight percent are going to have diabetes. Forty-eight percent will be under excessive levels of stress.

So, using those national statistics we can generally decide what types of interventions to offer, but clearly you want to also understand that population for more specific types of interventions.

David: We are here at Consumer Health World in Las Vegas. I was wondering if you could tell me what you are doing here, if you are speaking and what you hope to get out of the conference.

Don: Besides enjoying the Las Vegas nightlife I am here to speak on the essential characteristics of successful worksite wellness programs. I have identified a number of key benchmarks that any employer or managed care organization would want to make sure are included in their worksite wellness program in order to get that return on investment, David, that you alluded to.

David: I have been speaking today with Don Powell, PhD. He is President and Chief Executive Officer of the American Institute for Preventive Medicine. Don, thanks for your time again today.

Don: Thank you, David. Very nice to be here.

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