HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, October 19, 2007

FDA Concludes Many Children Do NOT Need Cold Medicines and the Associated Press report, 

Cold and cough medicines don’t work in children and shouldn’t be used in those younger than 6, federal health advisers recommended Friday.

The over-the-counter medicines should be studied further, even after decades in which children have received billions of doses a year, the outside experts told the Food and Drug Administration. The FDA isn’t required to follow the advice of its panels of outside experts but does so most of the time.

“The data that we have now is they don’t seem to work,” said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the FDA experts gathered to examine the medicines sold to treat common cold symptoms. The recommendation applies to medicines containing one or more of the following ingredients: decongestants, expectorants, antihistamines and antitussives.

The nonbinding recommendation is likely to lead to a shake up in how the medicines — which have long escaped much scrutiny — are labeled, marketed and used. Just how and how quickly wasn’t immediately clear.

In two separate votes, the panelists said the medicines shouldn’t be used in children younger than 2 or in those younger than 6. A third vote, to recommend against use in children 6 to 11, failed.

Earlier, the panelists voted unanimously to recommend the medicines be studied in children to determine whether they work. That recommendation would require the FDA to undertake a rule-making process to reclassify the medicines, since the ingredients they include are now generally recognized as safe and effective, which doesn’t require testing. The process could take years, even before any studies themselves get under way.  . . . .

October 19, 2007 | Permalink | Comments (0) | TrackBack (0)

Impotence Drugs Linked to Hearing Loss

Oops - yet another unsettling side effect of impotence drugs - reports,

Men taking any of three erectile dysfunction drugs -- Viagra, Levitra or Cialis -- may be at increased risk for sudden hearing loss, prompting Food and Drug Administration officials to require label changes for the medications.


The FDA is requiring label changes for drugs that may increase the risk of sudden hearing loss.  The FDA said manufacturers must change the labels "to display more prominently the potential risk of sudden hearing loss," according to the agency's Web site.

Labeling must also be changed for the blood pressure medication Revatio, which has the same active ingredient as the other drugs. Men taking any of the ED drugs and experiencing hearing loss should immediately stop taking the drug and see their physician, the FDA said. . .

   The FDA is requiring the label change for the entire class of drugs -- called Phosphodiesterase Type 5 Inhibitor, or PD-5 inhibitors.

I cannot wait for the new commercials . . .

October 19, 2007 | Permalink | Comments (0) | TrackBack (0)

Thursday, October 18, 2007

Congress Fails to Override SCHIP Veto

The House of Representatives failed to obtain the necessary votes to override President Bush's veto of the SCHIP program.  TPM election central reports,

It's over: The House just voted on the SCHIP bill moments ago, and failed to override President Bush's veto.

The vote was 273-156, falling short of the two-thirds vote needed to overturn Bush's veto.

Incredibly, despite polls showing strong majority support for a veto override, and an aggressive ad campaign targeting Republicans on SCHIP, the GOP was remarkably successful in holding the line and sustaining Bush's veto. Only forty-four Republicans voted for the bill -- almost exactly the same as last time, save for GOP Rep. Pete King, a bill supporter who was absent this time. One-hundred and fifty-four GOPers voted against it.

The roll call is here. has more here and ThinkProgress reports on future efforts to revive the SCHIP program here.

October 18, 2007 | Permalink | Comments (0) | TrackBack (0)

Wednesday, October 17, 2007

Dr. Susan Orr - Acting Ass't Secretary for Population Affairs

President Bush appointed Dr. Susan Orr, formerly Associate Commissioner of the Children's Bureau in the Administration for Children and Families, as the Acting Deputy Assistant Secretary for Population Affairs at the Office of Public Health and Science (OPHS).  There is just one small drawback with her appointments as RHrealitycheck reports

The Office of Population Affairs advises the Secretary and the Assistant Secretary for Health on "a wide range of reproductive health topics, including adolescent pregnancy, family planning, and sterilization, as well as other population issues," says the OPHS website. Sounds like you might want to count contraception as one of your areas of expertise in that post, right? Not Dr. Orr! In 2001, when President Bush proposed eliminating the requirement that federal employees' health insurance offer a range of options for birth control coverage, Dr. Orr, then the senior director for marriage and families at the Family Research Council, told the Washington Post, "We're quite pleased because fertility is not a disease. It's not a medical necessity that you have [contraception]."

Clearly, Dr. Orr's definition of "medical necessity" does not recognize that women in the world over consider controlling their bodies and the number and spacing of their children foundational to their well-being. If that's not a medical necessity, what is?

Mary Jane Gallagher, president of the National Family Planning and Reproductive Health Association, said in a statement that her organization was "appalled" at Orr's appointment and observed that "While her resume suggests a commitment to child welfare and children her professional credentials fail to demonstrate a commitment to comprehensive family planning services for all men and women in need."  . . . .

And ThinkProgress chimes in with some further thoughts from Dr. Orr about the value of contraceptive devices: 

In a 2000 Weekly Standard article, Orr railed against requiring health insurance plans to cover contraceptives. “It’s not about choice,” said Orr. “It’s not about health care. It’s about making everyone collaborators with the culture of death.

Wow, yet another great appointment - I am sure women everywhere feel better about their reproductive health already.  How did President Bush find someone so outstandingly qualified for this job - well - let us look at her credentials:  According to ThinkProgress, "Before joining HHS, Orr served as senior director for marriage and family care at the conservative Family Research Council and was an adjunct professor at Pat Robertson’s Regent University." 

October 17, 2007 | Permalink | Comments (0) | TrackBack (0)

FDA Hearing on Toddler Cold Medicines

As  you are probably well aware, last week several manufacturers of cold medicines for toddlers recalled their products from the market.  This Thursday, the FDA will hold hearings on the safety of these cold medicines.

On Thursday, the Food and Drug Administration will meet to discuss whether over-the-counter cold medicines are safe and effective in children age 6 and under. Earlier this year, the FDA completed a review that found between 1969 and the fall of 2006 there were 54 reported child deaths from decongestants and 69 from antihistamines. Most of the deaths occurred in children under 2. Baltimore Health Commissioner Dr. Joshua Sharfstein headed the push that led to the FDA hearing. He became alarmed when four Baltimore children died after their parents gave them excessive doses of cold medicines. "I didn't quite realize that it could potentially be a life-and-death issue," says Sharfstein.

In August, federal health officials recommended the "consult your physician" advice to parents on the labels of cold and cough medicines aimed at young children be replaced by a warning not to use the medications in children under 2 unless directed to do so by a health care provider.

   Last week, in advance of the hearings, some of the leading manufacturers of cold and cough medicines announced a voluntary recall of more than a dozen cold medicines for infants. The Consumer Healthcare Products Association said the products were being pulled "out of an abundance of caution."

Potential misuse of the medications, not product safety, is driving the voluntary withdrawal, the group said.  In a written statement, the group's president, Linda Suydam said, "It is important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately."  The recall "in no way affects our taking this issue to the advisory committee meeting," said Dr. Joel Schiffenbauer, deputy director for the FDA's Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products, Center for Drug Evaluation and Research. "All potential actions are on the table," he said.

I wonder if some parents will hoard this drugs and continue to use them anyway - as a close friend has predicted.  I am not so sure that I agree about the potential for hoarding but I admit when the doctor informs me that my son, who is coughing and snuffling and quite unhappy, has a virus and all he needs is some TLC, I feel like asking for drugs for myself.

October 17, 2007 | Permalink | Comments (0) | TrackBack (0)

Tuesday, October 16, 2007

Annual Check-Ups Overrated

It turns out those annual visits to your doctor are actually not that helpful.  According to an article in the Chicago Tribune


     Your doctor probably knows it. Medical organizations certainly do. But most  patients have no idea.  The annual physical examination -- that encounter when a physician looks in your throat, listens to your heart, pokes your abdomen, checks your reflexes and tests your blood -- is no longer a generally recommended medical practice. That's because there is scant scientific evidence showing that yearly checkups help prevent disease, death or disability for adults with no symptoms. Many tests and procedures performed during the visits have questionable value, experts say.

Instead of an annual physical, healthy adults should undergo a much-streamlined exam that's focused on prevention every one to five years depending on a person's age, sex and medical profile, the American College of Physicians and other professional groups suggest.

Men and women see physicians more frequently for yearly medical checkups than for any other reason, at a cost of $7.8 billion a year in the U.S., close to the $8.1 billion spent on breast cancer care, according to a recent report in the Archives of Internal Medicine. The figure reflects the strong attachment to this entrenched medical tradition felt by patients and doctors.  "There's a feeling of well-being you get from having your doctor look you over and pronounce you in good health," said Andrew Griffo, 48, a financial adviser who lives in Park Ridge and schedules a physical every year.  Largely out of public sight, however, the medical orthodoxy that all adults should undergo a comprehensive annual medical review to detect potentially significant clinical abnormalities has been under scrutiny since the 1970s. 

Experts' concerns revolve around two components of the traditional checkup: the comprehensive physical exam and an extensive battery of tests checking a person's blood, urine, thyroid and heart. (A third component, an updated patient history, hasn't prompted the same scrutiny.)   . . . .

Some believe that for many patients an annual checkup may not be needed at all. In fact, the new Archives of Internal Medicine study found most patients receive the bulk of recommended preventive care -- such as counseling about weight or blood-pressure checks -- not during physicals but on other occasions, such as when they see doctors about a cold or a chronic condition like diabetes.  The report also estimates that, a third of the time, routine physicals become an occasion for unnecessary tests such as electrocardiograms, boosting medical bills by more than $350 million and contributing to soaring medical expenses.

There's good reason to ask "whether the time and resources being spent are worth it," said Dr. Ateev Mehrotra, the study's lead author and assistant professor at the University of Pittsburgh School of Medicine.

Thanks to Ezra Klein for the link.

October 16, 2007 | Permalink | Comments (0) | TrackBack (0)

Reproductive Health Website

Here is a helpful reproductive health website.

October 16, 2007 | Permalink | Comments (0) | TrackBack (0)

Myths about SCHIP

Here is a nice run-down about some of the truths and myths about the SCHIP program from the folks at Families USA and Firedoglake:

FamiliesUSA has put out a mythbusting fact sheet about SCHIP, a sad and tragic necessity in the wake of the abject lies told by the President of the United States and those who get off licking his shoeleather. To wit:

Claims by the President that this bill raises the CHIP eligibility level to $83,000 (400 percent of the federal of the poverty level) in annual income are unambiguously false. There isn’t a single state in the country with such a high eligibility level. One state, New York, wanted to set the eligibility standard at that level, but its request to do so was denied by the Administration.

I’m also fond of the newfound sense of fiscal responsibility espoused by George Bush, who now says we simply can’t afford that kind of expenditure if it’s kids’ lives on the line instead of, say, nuclear warheads.

October 16, 2007 | Permalink | Comments (0) | TrackBack (0)

Monday, October 15, 2007

Republicans for Health Care Reform

Republicans have moved toward promoting a form of health care reform according to the

Under fierce attack by Democrats over the children’s health insurance plan, House Minority Leader John A. Boehner said Sunday Republicans will unveil their own health care plan over the next few months.

“Republicans are working on a plan that will provide access to all Americans to high quality health insurance, make sure that we increase the quality of insurance that we have in American, and we want to foster a sprit of innovation,” said Boehner on “Fox News Sunday.” “This is a plan we’ll see over the next coming months where we put the patients in charge of their health care.”

Republicans have taken a beating on SCHIP, the $35 billion measure that would expand health insurance for children. The fight quickly turned nasty as Democrats ran campaign ads attacking Republicans who voted against the bill in their home districts.

Should be interesting to see what both parties come up with for health care reform.  Perhaps we might actually see some movement toward more coverage for all.


October 15, 2007 | Permalink | Comments (0) | TrackBack (0)

Sunday, October 14, 2007

Smaller Class Sizes and Health has an interesting article discussing the impact of class size on elementary school children's health:

This week, Dr. Sydney Spiesel discusses a potential link between smaller elementary school class sizes and better health, a safer way to give painkillers, and treatments for ADHD.

Smaller classes, better health?

Question: An extraordinarily provocative article in this month's American Journal of Public Health ties together two seemingly unrelated phenomena: the size of school classes and the health of students. Could smaller class sizes be a good investment not only for educational reasons but for medical ones?

New study: Peter Muennig of the Columbia University School of Public Health and Stephen Woolf of Virginia Commonwealth University in Richmond drew their data from Project STAR, which began in 1985 and randomly assigned almost 12,000 Tennessee kids to classes of different sizes in kindergarten through third grade. Some of the kids were in classes of 22 to 25 students, and others were in classes of 13 to 17 students. Teachers were also randomly assigned. The children were then tracked to determine the effect of class size on educational attainment.

Model: The educational effects were considerable. Now Muennig and Woolf are making use of the findings in a whole new way. They used Project STAR's statistics about educational attainment to build a computer model of a hypothetical group of 5-year-olds exposed for four years to small classes (of 13 to 17) and then followed until the age of 65. The researchers calculated projected earnings, welfare payments, and crime costs based on what we know about the relationship between these outcomes and educational attainment. They also drew on statistics relating degree of education to quality-of-life scores and age-specific mortality. And they accounted for the cost of maintaining smaller class sizes.

Findings: Based on their model, the authors project that reductions in class size would generate a lifetime net cash return of almost $200,000 (presumably in the form of taxes collected) for each additional low-income student who graduates from high school as a result of early placement in a small class. In addition, they project that four years of small classroom size will lead to improvement in health and longevity. These benefits, they calculated, would on average add up to the equivalent of an additional 1¾ years of life in perfect health.

Conclusion: It's important to point out that these numbers are based heavily on assumptions that might not hold true for the future or for places outside Tennessee (kudos, by the way, to that state for supporting this bold experiment). But these are plausible assumptions, at least. And the numbers they generate are astonishing, because they suggest that investment in reducing elementary school classes is better, in cost-benefit terms, than money spent on antibiotics, or hospital buildings, or even vaccines (long thought to be one of the most cost-effective interventions for health care). Perhaps I would do better for my patients if I gave up pediatrics and became a member of my local school board.

October 14, 2007 | Permalink | Comments (0) | TrackBack (0)

Our Teeth and Our Health Care System

Frank Pasquale at Concurring Opinions has some observations about our teeth and the state of our health care system.  He writes,

What is the future of American health care?  Many believe that we need less reliance on government funding.  The current state of American dentistry suggests the likely consequences of such a move--along with the imbalances caused by "marketization" that focuses on the demand side while neglecting a cartelized supply side.

As social stratification deepens, ever more sophisticated cosmetic dentistry becomes the norm for the wealthy.  Meanwhile,

[M]any poor and lower-middle-class families do not receive adequate care, in part because most dentists want customers who can pay cash or have private insurance, and they do not accept Medicaid patients. As a result, publicly supported dental clinics have months-long waiting lists even for people who need major surgery for decayed teeth.

[E]ven as so many patients go untreated, business is booming for most dentists. They are making more money while working shorter hours, on average, even as the nation’s number of dentists, per person, has declined.


Even if more students wanted to enter the profession, states are not moving aggressively to expand dental schools or open new ones. Training dentists is expensive, because dental schools must provide hands-on training — unlike medical schools, which send doctors to hospitals for training after they graduate. Hospitals receive federal subsidies for the training they provide to medical interns and residents, but the equivalent system does not really exist in dentistry. Meanwhile, the A.D.A. does not support opening new dental schools or otherwise increasing the number of dentists. The association says it sees no nationwide shortage of dentists . . . .

So while the doctors' lobby has finally acknowledged the need for more medical schools, the dental lobby is holding a hard line.  One key question: is the problem that Medicaid underpays dentists, or the state's failure to assure the training of enough dentists? Consider the hard line the dental lobby takes against the allied health professions:

Despite the rise in dental problems, state boards of dentists and the American Dental Association, the main lobbying group for dentists, have fought efforts to use dental hygienists and other non-dentists to provide basic care to people who do not have access to dentists.


"What we’re extremely uncomfortable with is that they need to drill teeth and sometimes extract teeth,” said . . . the association’s president. Use of therapists would create a two-tier system where some people have access to dentists, while others must settle for less-qualified practitioners, she said.

The entire post is an interesting and thought-provoking read with a number of potential solutions discussed to the problem of physician shortages.

October 14, 2007 | Permalink | Comments (0) | TrackBack (0)