Boston Scientific (Natick, Massachusetts) and Guidant (Indianapolis) reported that the FTC granted antitrust approval for their $27.2 billion merger and they finalized the deal in late April just after the May issue of Biomedical Business & Technology went to press.

At the end of March, Boston Scientific reported that the companies' respective shareholders voted "overwhelmingly" to approve the combination of the companies at separate special meetings, this despite all the problems Guidant has had with its cardiac rhythm management products over the past year.

More than 96% of the shares represented at the meeting and more than 73% of the outstanding shares of Boston Scientific were voted in favor of the transaction at the Boston Scientific shareholders meeting. More than 98% of the shares represented at the meeting and more than 66% of the outstanding shares of Guidant were voted in favor of the transaction at the Guidant shareholders meeting.

"We are pleased and gratified by the strong support we have received from Boston Scientific's and Guidant's shareholders," said Boston Scientific president and CEO Jim Tobin. "We are excited about the prospect of creating a global leader in cardiovascular devices, and we are eager to begin working with our colleagues at Guidant to realize the substantial benefits this combination will bring to shareholders, employees, physicians and patients." "In Indiana-speak, that's pretty close to unanimous," quipped Guidant CEO James Cornelius.

The merger had been approved earlier in April by European Commission antitrust regulators.

In addition, Boston Scientific said the FTC also cleared the proposed $6.4 billion acquisition of Guidant's vascular intervention and endovascular businesses by Abbott Laboratories (Abbott Park, Illinois). The deal with Abbott was made to satisfy concerns that the combined company could command too great a share of the market for heart stents.

Abbott agreed to pay $4.1 billion in cash, and provide a $900 million loan to Boston Scientific and acquire $1.4 billion in Boston Scientific stock.

Guidant shareholders benefited from the delay in the closing of the merger which was supposed to be completed by March 31.

According to the merger agreement Guidant shareholders received an additional $0.0132 in cash per share for each day beginning on April 1 through the closing date of the merger – translating to roughly $4.5 million a day.

Boston Scientific on Jan. 25 won a nearly two-month bidding war with Johnson & Johnson (New Brunswick, New Jersey) to buy Guidant and its business in the fast-growing market for implantable defibrillators. The company has projected about one-quarter of its sales will come from Guidant's pacemakers and defibrillators.

U.S. med-tech – not translating to health?

It is commonly acknowledge that America is the primary generator of new medical technologies. U.S. companies have produced the most important new developments in cardiology, advanced imaging and a whole range of the latest in minimally invasive and robotic surgical systems. Capitalism’s profit motive is a huge driver for risk-taking activity that will frequently drill the proverbial “dry wells” but also result in those infrequent huge gushers in terms of technological advance.

And the U.S. governmental regulation system generally offers a developmental venue with as many incentives as restraints upon healthcare profit, as opposed to limitations on the for-profit motives in Canada and the regulatory and reimbursement restraints typical of other countries. Add to this other key factors: America’s acknowledged high “standard of living,” its well-reported ability to spend out-of-pocket dollars on all sorts of health products and services, and the soaring amount of money that Americans are putting into healthcare.

But there is evidence that these large drivers don’t translate to superior healthcare delivery and outcomes – a conclusion that can be drawn from a penetrating new study released in May, comparing a narrowly defined group of U.S. and British citizens.

The study looked at a group of white middle-class Americans and white middle-class British, comparing the health status of the two groups.

Its conclusion: that the group of Americans was not as healthy as their English counterparts. The healthiest Americans in the study – those in the highest income and education levels – had rates of diabetes and heart disease similar to the least healthy in England – those in the lowest income and education levels there. The research was supported by the National Institute on Aging (NIA), part of the National Institutes of Health and British government agencies.

The researchers chose comparable samples of people ages 55 to 64 from two large, national health surveys – 4,386 from the U.S. Health and Retirement Study and 3,681 from the English Longitudinal Study of Aging. Each sample was divided into three socioeconomic groups based on education and income. Both samples were limited to non-Hispanic white populations, allowing the researchers to control for special issues in different racial/ethnic communities in both countries.

Comparing self-reports of chronic diseases such as diabetes and heart disease between the two countries, the researchers found that Americans reported significantly higher levels of disease than the English. As one example, the prevalence of diabetes in the age group was twice as high in Americans as in the English. Also, the lowest income and education group in each country reported the most cases of diabetes, hypertension, heart disease, heart attacks, strokes and chronic lung disease, while the highest income and education groups reported the least.

The only disease for which this inverse relationship was not true was cancer. The study also found that differences between the two countries in smoking, obesity and alcohol use explained little of the difference.

James Smith, PhD, of the RAND Corp., Zoe Oldfield, MSc, of the University of London, and Sir Michael Marmot, MD, and James Banks, PhD, both of University College London, reported the comparison in the May 3 issue of the Journal of the American Medical Association. “This comparison raises some important questions about the relationship among health, education and income in both countries,” said Richard Hodes, MD, director of NIA. “As many nations try to address the challenges of population aging, it will be critical to know why these differences in health status appear.”

“This study challenges the theory that the greater heterogeneity of the U.S. population is the major reason the United States is behind other industrialized nations in some important health measures,” says Richard Suzman, director of NIA’s Behavioral and Social Research Program. “By focusing on the comparable white populations, this study still finds the U.S. lagging.”

Smith, Marmot and colleagues point out that the differences exist despite greater American health care expenditures, similar patterns in life expectancy between the two countries, and the fact that smoking behavior in the two countries is similar. The authors suggest some possible areas for further consideration and study.

The reasons for the difference?

One conclusion to be drawn, and perhaps the easiest, may be differences in insurance coverage policies of the two countries, with the large and increasing number of uninsured Americans being a primary culprit. Interestingly, most of those commenting on the study did not draw this conclusion, noting that, insured or not, the two groups seem to show about the same amounts of unhealthy behaviors.

Rather, a common theme was the overworked, stressed-out lifestyles of U.S. residents as opposed to the more vacation-friendly work patterns in Britain. This, of course, is a bleak conclusion for Americans.

And ever-improving technology isn’t likely to provide the path to improved health. Rather, it is more likely that unhealthy lifestyles will continually soak up more and more technology just to keep us alive, and that this pattern will continue to emphasize the euphemistic content of the term “healthcare,” and provide increasing amounts, at higher prices, of sickcare.

But dental care favors the U.S.

While the above U.S./Britain comparison favors the British, a comparison of dental care between the two countries clearly favors the U.S., at least according to a recent article in The New York Times.

Titled “In a Dentist Shortage, British (Ouch) Do It Themselves,” the article highlights the frequency of “snaggly toothed” Britain’s, pinpointing deficiencies in the country’s state-financed dental service, primarily a lack of dentists in the National Health Service. The system, according to the Times writer, is “stretched beyond its limit, no longer serves everyone and no longer even pretends to try.”

The article goes on to cite two results of this: residents combining dental care with holiday trips abroad in “dental vacations” and self-dentistry – that is, purchase of do-it-yourself materials to replace fillings, replace cracked crowns or perform other simple procedures while they wait for a regular dental appointment.

This has been a boon to a company called Passion for Health DenTeck which supplies these materials. The company has reported a 40% increase in sales over the past year. The article interviewed the company’s director of sales and marketing who noted a sort of sentinel difference between Americans and British: “In the U.S., we go through a spool of dental floss in six weeks, on average. Here, it’s a year and a half.”

A black eye for user fee program

Simmering discontent by medical device manufacturers with the FDA’s device user fee program was pushed into the spotlight last month, with the release of a new report indicating broad doubts concerning the program’s effectiveness and value to the industry. The impressions and reactions of these companies concerning the program are presented in a new report from The Lewin Group, titled “Medical Device Industry Perspectives on MDUFMA,” summarizing opinions concerning the program by 58 med-tech developers and device manufacturers

Device user fees, developed via MDUFMA legislation, were initiated as an attempt to provide assistance to the FDA to support its regulatory approval processes and, it was hoped by the industry, to accelerate the path to product commercialization. But the companies surveyed said that there has been “little evidence of improved return on investment (ROI),” according to a summary of the report. And: “The majority of industry respondents reported not being aware of hard data showing the impact of the program on ROI. This lack of evidence of the program’s impact increases concerns about unpredictable increases in user fees.”

That comment comes at a time when the user fee program is positioned to be re-instituted, and thus provides little support for that action.

Overall, the Lewin report points to the program’s “laudable intent” – and rather significantly – broad support of those purposes from the industry, but it found that those surveyed cited many more shortcomings than benefits.

The report says that 70% of the manufacturers who responded to the study “perceived that MDUFMA goals have not resulted in meaningful improvements in either the predictability or timeliness of device review.” And: “Many expressed that review times have, at best, remained ‘about the same’ compared to pre-MDUFMA experiences, possibly due to agency staffing and other operational constraints.”

The industry sees the user fees as a “double tax” and says that, instead, “the cost of premarket reviews should be included in annual appropriations,” according to the report.

Rather pointedly, it also details four “unintended consequences” of the user fee program:

That FDA reviewers “’game the system,’ intentionally or unintentionally, to meet MDUFMA goals” by stopping the review clock in a variety of ways, such as by issuing formal requests for additional information. This has resulted in delays that are not reflected in the final regulatory timeline. The report says that at least half of the companies surveyed reported this as a “perception.”

That there is no method for handling “minimal information requests” as an alternative to formal requests. And the report says that most manufacturers prefer “clock-stopping” pathways for these less formal requests since the more formal pathways tend to result in delays of from 30 to 90 days.

That the program has resulted in FDA staff giving “greater priority to MDUFMA deadlines than communication with technology sponsors. This may have its most acute effect in the early stages of product development, where understanding the nuances of FDA’s requirements for a particular submission . . . is pivotal to key matters.”

That the prospect of “unpredictable increases in user fees can dampen anticipated ROI of novel products, particularly when such user fees are of a consequential magnitude compared to early product development costs for companies with limited resources or funding streams from other products.”

Among the other major shortcomings that the survey found among those responding was a lack of transparency in reporting performance data and explanations for user fee increases and rather widespread “cynicism” concerning the program’s resulting in the hiring of new staff to bolster the program.

Rare diseases to be new NIH effort

The National Institutes of Health (NIH; Bethesda, Maryland) has rolled out plans to launch the first clinical studies of its Rare Diseases Clinical Research Network (RDCRN), which was funded at $71 million for the initiative in 2003. More than 20 studies are expected to open in the next few months at about 50 sites across the U.S. and in several other countries including the UK, Japan and Brazil.

“The idea is that we’re really trying to set up a model of research of rare diseases in which you use multiple research sites throughout the country, and in fact, there are several international studies as well focusing on particular diseases [with] a common protocol for many of the studies,” Stephen Groft, director of the NIH Office of Rare Diseases (ORD), told BB&T. He noted that the emphasis will be on the genetic basis of these diseases, in essence requiring more “personalized” therapies.

“During the past year, we’ve gotten about 23 studies that have been approved by the NIH to start, and we’re just in the process of rolling out the studies to people who have these diseases and provide ready access to research sites,” Groft said.

He estimated that there are more than 6,000 rare disorders – specifically defined as a disease or condition affecting fewer than 200,000 persons in the U.S. But the cumulative effect is “a lot,” he said. The NIH estimates that such diseases impact 25 million Americans.

A central data and technology coordinating center and 10 research consortia will be established to conduct these investigations.

“By studying the genetic component of these rare diseases, we hope to be able to better predict the course of the illnesses and provide more effective, personalized treatments for those afflicted,” said Elias Zerhouni, MD, director of NIH. “Ultimately, this individualized approach, completely different from how we treat patients today, will allow us to prevent or to promptly treat the complications arising from these genetic disorders.”

Groft said the NIH first began considering the program because it recognized that the government needed to “do more” to provide incentives to private pharmaceutical companies to conduct such studies.

The initiative includes interventional trials to test new therapies or drugs, as well as longitudinal or natural history studies that will provide information about the characteristics of rare diseases and their progression over time. The data produced will be made publicly available with appropriate safeguards for patient confidentiality, NIH said.

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