Medical Device Daily Executive Editor
And MDDs

In the early 1980s, the Federal Communications Commission pursued an effort to regulate the TV advertising of highly sugared products — primarily candies and cereals — directed at children, saying that such advertising led to significant increases in tooth decay and other childhood ills.

Dubbed "kidvid," that effort failed to block such advertising but tended to have the more general effort of moving television programming into specific time slots.

Now, the FCC is taking on a broader and bulkier issue, the media's role in childhood obesity.

The FCC has established a 30-member task force that will target the subject and reportedly will hold a meeting on the topic next month, zeroing in on the methods food manufacturers pitch their products to children and perhaps adding to the problem of childhood obesity.

Those supporting the approach say that, at the very least, discussion of the topic at the federal level may encourage the food industry to make voluntary changes in their approaches in order to avoid government regulation.

Critics argue that changes in advertising won't have much impact on the problem since it requires much more fundamental changes in exercise and general behavior.

Current estimates put the number of obese children in the U.S. — those between the ages of 6 and 11 — at about 15% of all children, and the figure is slightly higher for adolescents.

Insurance expansion plan proposed

The Federation of American Hospitals (Washington), a large hospital group — representing an estimated 17% of U.S. hospitals — last week proposed a plan to expand healthcare coverage to all Americans, adding to a growing debate on this issue and likely to be a hot topic in the already-initiated positioning by presidential candidates.

The plan, titled "Health Coverage Passport," calls for expanding eligibility for the current Medicaid and state children's health insurance programs for lower-income people. It would provide subsidies for those who are employed and have access to an employer plan, but cannot afford it, and to those purchasing individual private plans. Some parts of the plan would include tax breaks for those buying private coverage plans.

Individuals purchasing coverage on their own would also be subsidized, according to income, and they could deduct insurance costs from income taxes as employers do now.

"Our Health Coverage Passport addresses the flaws in our system that have left so many Americans uninsured without unraveling the private and public coverage that so many Americans depend on today," said Chip Kahn, president of the federation in a statement. "All Americans can be covered without turning the world upside down — the Health Coverage Passport shows the way."

The reference to avoiding "turning the world upside down," is seen as an attempt by the group to maintain private insurance plans rather than moving to a one-payer government plan. It has also been noted that Kahn was a strategist leading opposition to the efforts by the Clinton administration to develop comprehensive government insurance.

Some have suggested that the proposal may be as much symbolic as actual, noting that Kahn has acknowledge that he didn't see enactment of this or any other similar proposal until after the 2008 presidential election. The plan, he indicated, has the initial goal of influencing debate on the topic.

It has been estimated that adding the additional coverage would cost somewhat north of $115 billion annually.

With roll-out of its plan, the federation also released the results of a survey that it said found that 86% of Americans want action by federal legislators to address the problem of the large numbers with no healthcare insurance.

Cardio warnings issued for ADHD drugs

Faulty drugs have more than an adverse impact on patients. They often create work for other sectors of the med-tech industry.

The FDA on Friday said it is requiring manufacturers of all drugs approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

The FDA put the frequency of ADHD at 3%-7% of school-aged children and about 4% of adults.

The agency said its review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

It said that another of its reviews showed an increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems. And it advised those considering treatment for ADHD with drugs to work with clinicians "to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, MD, director, Center for Drug Evaluation and Research. "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

FTC to host 'authentication' workshop

The Federal Trade Commission last week reported that it will hold a public workshop on new technologies for identify authentication on April-24.

The workshop, "Proof Positive: New Directions in ID Authentication," will involve a variety of groups to discuss methods to reduce identity theft through enhanced authentication, focusing on technological and policy requirements for developing better authentication processes, including the incorporation of privacy standards and consideration of consumer usability issues.

The agency said it is seeking public comments in planning the agenda for the workshop, and is inviting parties interested in participating as panelists to notify the agency. The agency invites comments on ways to improve authentication processes to reduce identity theft, including, but not limited to, comments on the following:

How can individuals prove their identities when establishing them in the first place?

What are some current or emerging authentication technologies or methods — for example biometrics, public key infrastructure, and knowledge-based authentication — and what are their strengths and weaknesses?

To what extent do these technologies meet consumer needs, such as ease of use, and to what extent do they raise privacy concerns?