Last December, a consumer watchdog group questioned the legality of advertising medical devices on YouTube, and called on regulators to crack down on such promotions. The videos tout the benefits of the devices but do not mention the risks, according to the group, in contravention of US Food and Drug Administration rules requiring a balanced picture of benefits and risks.

The FDA has also been panned (again) for its expedited 510(k) medical device review process designed to promote innovation. A breast cancer patient whose doctor recommended brachytherapy using the MammoSite system was “shocked” to discover that the device was still experimental. Although it has since been used in about 45,000 cases, MammoSite was given expedited clearance on the basis of a study involving only 25 women.

Neither the study nor the FDA approval process addressed MammoSite’s effectiveness against breast cancer. There appears to be still no conclusive proof that brachytherapy works as well as conventional radiation for the breast, but one hospital that has used MammoSite to treat 600 patients so far said breast cancer recurred in only three of them, a result better than would have been expected with standard radiation therapy.

Critics contend that the public might misinterpret FDA approval to mean that a device is indeed medically effective. A national study of MammoSite’s effectiveness is underway but could take decades to conclude whether it is better than conventional radiation.

The 501(k) process has become “a barrier to evidence development,” one analyst told HealthLeaders writer Reed Abelson, but its defenders argue that it provides patients with the opportunity to choose promising alternatives.

Among those promising alternatives is the genomic test for diagnosis of predisposition to disease. A group of concerned scientists in the UK who think such tests may be inaccurate and even harmful has asked the British government to tighten regulation. The group’s objections include:

  1. The tests do not determine the implications of their own findings,
  2. The pin-prick blood tests required for some tests could be invalidated by contamination with other body fluids, and
  3. The integrity of body fluids sent in the mail could be affected by temperature and other factors.

Innovation is also under attack on ethical, scientific, and financial grounds. Citing the case of CT scans, which “have never been proved in large medical studies to be better than older or cheaper tests [and] expose patients to … a small but real cancer risk,” Alex Berenson and Reed Abelson wrote in a New York Times article in June 2008 that “A faith in innovation, often driven by financial incentives, encourages American doctors and hospitals to adopt new technologies even without proof that they work better than older techniques.”

Whether that assertion is true or not, how is proof to be obtained before a technology is sufficiently widely adopted to enable scientifically valid and reliable evaluation? There is a prima facie case in favor of the hypothesis that CT angiography is better than conventional angiography in the images alone: When primary-care doctors see CT images, one cardiologist told the reporters, “they become true believers.” “The scans sort of sell themselves,” said one primary-care doctor.

Some detractors admit that improved future versions of CT could “revolutionize the treatment of heart disease,” but for now, the CT angiogram is “a great technology searching for a great application,” as one expert put it.

The reporters wrote a fairly well researched and balanced piece, but in our view they overstate the claim that profit drives “faith” in innovation, underestimate physicians’ desire to practice better medicine and deliver better healthcare, and fail to put the issue fully into the context of paradigmatic change in the business and practice of healthcare.

In contrast, an IEEE and National Institute of Standards and Technology (NIST) conference in 2007 on Economic Strategy for Health Care through Standards and Technologies did just that. The conference conclusions:

  1. The current state of healthcare expenditure is neither sustainable nor commensurate with lower costs and improved quality.
  2. Current economic models and research strategies are not sufficient to provide for the development of new diagnostic, therapeutic or preventative approaches; the diagnostic testing required for reversing the increasing trend of health spending; and meeting expectations for quality of life.
  3. A paradigm shift in health care delivery is only possible with implementation of biological and information technologies and appropriate standards.
  4. The implementation of these technologies and standards requires a long-term economic strategy that facilitates identification and implementation of the most promising and necessary technologies and their validation and standardization requirements.
  5. Research and academic expenditures for ground-breaking, government-supported, scientific studies need to be supported by long-term economic strategy.
  6. A national process for developing a long-term economic strategy should be developed and involve all healthcare stakeholders.

The conference called for a shift to personalized healthcare delivery at the molecular level, but noted that a shift of such magnitude could be achieved only through the integration of breakthrough technologies into current best practices. In particular, we must develop HIT that reduces the “staggering” volumes of molecular-level data into simple hypotheses about health and disease.

There is no doubt that imaging technologies add to the healthcare bill. All we ask is that discussion of remedies is made in light of the broader context of accelerating change, as presented at the IEEE conference and frequently urged in our own commentaries.

Doctor Shortage

The same need to factor in accelerating change in a broader context applies to discussion of the alleged impending doctor shortage. It is claimed that the US faces a doctor shortage of 200,000 in the year 2020, of whom apparently only 4,080 will be cancer doctors. The general physician shortage already has resulted in a rapid increase in the number of nurse practitioners, who could also be trained to take over some aspects of cancer care, a member of the American Society for Clinical Oncology said. However, nurse practitioners may be less able to ameliorate the decline in general surgery, one of the few fields where the absolute number of surgeons is actually shrinking.

We can also expect patients themselves to ameliorate the doctor shortage. Indeed, “Helping people to do more for their own health care may be the only thing that saves health care reform,” wrote Don Kemper recently on the Health Care Blog. Giving people, and incentivizing them to use, efficient and effective tools for self-care, disease self-management, and decision support will also help alleviate “the overtreatment and under-caring so prominent in today’s health care system,” Kemper continues.

As noted above, one medical tool increasingly available to the public is the genetic test. Emily Singer reports in Technology Review that “paternalistic concerns” about people’s ability to understand the results of these “somewhat subtle” tests have been “subdued” by two recent studies suggesting that most patients cope easily with negative genetic information (that tells them, for example, that they are susceptible to Alzheimer’s later in life).

Perhaps the most obvious way to deal with the doctor shortage is to increase enrolment at medical schools, and that is indeed happening, according to a conference report published last October by the Josiah Macy, Jr. Foundation. It reported that nine new allopathic medical schools are under development with at least five more in planning and all but 18 of the 126 existing schools are increasing class size, which will result in an additional 5000 physicians each year by 2020, not counting those coming from nine new osteopathic schools added since 2000 to the 19 already in existence, with more planned.

Unfortunately, if the 200,000-physician deficit is correct, that number is clearly a drop in the bucket; and more unfortunate still, the report added: “the enormous changes that have transformed medicine over the past century have outstripped the ability of the [extant model of medical education] to prepare future physicians adequately for the challenges and expectations of the new century.” Two paragraphs from the report resonate with arguments we have made repeatedly:

The overarching theme that coursed through the discussions was the urgent desire to bring medical education into better alignment with societal needs and expectations. Hence, much of the discussion focused on contemporary realities that are not yet adequately reflected in the preparation of future physicians. Notable examples include the accelerating pace of scientific discovery; the determined calls for more public accountability; the unsustainable rise in healthcare costs; the well-documented shortfalls in healthcare quality; the unconscionable racial and ethnic disparities in health and healthcare; and the inexorable increase in the burden of chronic illness and disability.

Among the tasks identified for medical schools were the following: (a) re-define the science that is the foundation of medicine; (b) underscore the importance of problem solving and self-directed learning in an era of exploding knowledge; (c) ensure that students experience continuity of care for individual patients, especially those with chronic illnesses; (d) provide students with opportunities to learn the principles of quality improvement and patient safety; (e) place less emphasis on hospital venues and more on community settings as “classrooms” for educating future physicians; (f) prepare students to work effectively as members of interprofessional teams; (g) broaden the understanding of public health and non-biologic determinants of illness; (h) foster long-term relationships between students and faculty; and (i) develop the teaching and mentoring skills of faculty.

Biotech Patent System Broken

While the West worries about the cost of too much new intellectual property (IP) in healthcare, the system that controls it is denying lifesaving technologies to people in both developed and developing countries, according to a report released last September by an international coalition of experts. The reasons:

  1. Lack of trust between industry, researchers, and potential recipient communities,
  2. An increasingly dysfunctional industry that relies on outdated conceptions of IP,
  3. Fixation on patents and privately-controlled research, and
  4. A pharmaceutical industry with an increasingly bare medicine cabinet.

The report recommends the usual solutions—work together, develop partnerships, standardize the international IP system, transparency, etc.

In any event, the IP system seems to be offering less and less protection to industry. Bloomberg News reported last year that seizures of bogus prescription medicines jumped 24 percent to 1,513 incidents in 2007, and illicit versions of 403 different prescription drugs were confiscated in 99 countries. This $3 billion-worth of counterfeit drugs included not only generic copies that violate patent laws but also products lacking active chemical ingredients or containing improper dosages.

In the decade since Internet sites began selling illegal copies of Viagra, counterfeiters have diversified, marketing pills to treat heart disease, arthritis, asthma, AIDS, and cancer.

It will only get worse, unless we find ways for the consumer to validate the authenticity of drugs.


Designer Babies

Early this year a Los Angeles clinic began offering couples the chance to design their own babies, choosing gender, eye, hair, and skin color, via pre-implantation genetic diagnosis (PIGD). According to a BBC report in March, the clinic’s website at that time said it made “NO guarantees as to ‘perfect prediction’ of things such as eye color or hair color.” We just checked, and there is no longer any mention of any genetic selection service on the website except gender selection (which is “100 percent guaranteed”), so the controversy over the morality of designer babies perhaps has had an effect–we don’t know.

Our growing ability to design babies for health and not just aesthetic reasons could feed demand. Last year British scientists created a gene “karyomapping” test that can tell parents-to-be in a matter of weeks whether their embryos are affected by any one of 15,000 inherited diseases.

The chairman of the British Fertility Society told the BBC: “… obviously, the ethical question is, if you can screen for anything, where do you draw the line?” It is surely indisputable that gender selection alone amounts to baby design. Furthermore, it is illegal in many countries (though that is not stopping an apparently growing demand for the service.) One wonders, then, why an arbitrary line would appear to have been drawn under gender selection but above eye-color selection at the LA clinic.

The ethical debate is urgent and important, not because it might put a stop to designer babies (it won’t) but because it gives society at least some opportunity to regulate the practice to prevent excesses and abuses.

Simulators vs. Animals

PETA, a US animal rights group, is among groups putting pressure on hospitals and other

medical institutions to limit or replace the use of animals to practice. One hospital was sued for its use of cats for pediatric intubation practice, another for use of ferrets for intubation practice and live pigs for surgeries.

The pressure seems to be having an effect. A program developed by the American Heart Association and taught across the country “does not require or endorse the use of live animals” during the courses. A similar course uses hi-tech mannequins instead of animals. The lifelike mannequins are able to blink, give blood pressure readings, and simulate a collapsed lung. They “have developed to the point where they are able to mimic conditions that are ‘pretty close’ to live humans, reports Todd Frankel in the St. Louis Post-Dispatch.

US Set to Retake ESC Ground from the UK

President Obama’s removal of restrictions on federal funding of embryonic stem cell research, imposed by President Bush in August 2001, is likely to cause an explosion of advances as pent-up research gets under way.

Biotech firm Geron plans to take an embryonic stem cell treatment for spinal cord injury into the clinic. The firm wants to inject embryonic stem cells directly into the spine of newly paralyzed patients. In trials on rats, the animals regained some function. Geron says it has enough undifferentiated stem cells to potentially treat every spinal cord injured patient in the United States for the next two decades. Geron’s next application will be for a stem cell treatment for heart failure. It’s also working on treatments for diabetes, liver disease, bone and cartilage repair.

Meanwhile, although the UK has been even more aggressive legislatively than the US (its Human Fertilisation and Embryology Act of 2008 allows “human-admixed” embryos to be created from a combination of human and animal genetic material for research, for example), red tape and poor investment threatens the future of UK stem cell work moving from research to real life therapies.

An example is Moorfields Eye Hospital, which is using stem cells to treat blinding ocular surface disorders. It took them five-years of struggling with regulators and financing sources to get the treatment from the bench into the clinic.Another is the London Project to Cure Blindness at University College London, which has made a bank of stem cells with the potential to treat some six million patients who have age-related macular degeneration. But all of the funding to move the work from the bench to the bedside has come from the US. and unless more investment comes in from the UK then this project will go to the US. That seems quite likely to happen, given the British bureaucrats’ response:

  1. Soothe: “The Department of Health believes that stem cell research offers enormous potential to deliver new treatments for diseases and is spending more than £40m a year on all types of research;”
  1. Delay: “The Department of Health and its Gene Therapy Advisory Committee are currently working with other regulators in the field to produce a ‘Regulatory Route Map’ to provide further clarity on the regulatory requirements for the clinical use of stem cells;” and
  1. Deny: “The Medical Research Council said it was unaware of any clinical studies or trials that had been held up by regulatory procedures.”

China Health System Reform

The US is not the only country trying to reform a huge health system. The Chinese government once covered more than 90 percent of medical expenses but today it covers only about 17 percent, forcing public hospitals to seek profits from medical services and drug prescriptions to cover their operating expenses. The public has suffered as a result. Major reforms, to be tested in a few cities over three years, will subsidize medical equipment, academic research, physician training, retiree health costs, and the construction of some 2,000 county-level hospitals.


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