HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, January 3, 2009

Third-Hand Smoke

Images The New York Times reports on the new term - third-hand smoke.   Apparently smoking is even worse than we thought in terms of lingering air pollution.   The story states,

Parents who smoke often open a window or turn on a fan to clear the air of second-hand smoke, but experts now have identified another smoking-related threat to children’s health that isn’t as easy to get rid of: third-hand smoke.

      

That’s the term being used to describe the invisible yet toxic brew of gases and particles clinging to smokers’ hair and clothing, not to mention cushions and carpeting, that lingers long after smoke has cleared from a room. The residue includes heavy metals, carcinogens and even radioactive materials that young children can get on their hands and ingest, especially if they’re crawling or playing on the floor.

Doctors from MassGeneral Hospital for Children in Boston coined the term “third-hand smoke” to describe these chemicals in a new study that focused on the risks they pose to infants and children. The study was published in this month’s issue of the journal Pediatrics. . . .

Third-hand smoke is what one smells when a smoker gets in an elevator after going outside for a cigarette, he said, or in a hotel room where people were smoking. “Your nose isn’t lying,” he said. “The stuff is so toxic that your brain is telling you: ’Get away.’” . . .

But far fewer of those surveyed were aware of the risks of third-hand smoke. Since the term is so new, the researchers asked people if they agreed with the statement that “breathing air in a room today where people smoked yesterday can harm the health of infants and children.” Only 65 percent of nonsmokers and 43 percent of smokers agreed with that statement, which researchers interpreted as acknowledgement of the risks of third-hand smoke. . . .

Dr. Philip Landrigan, a pediatrician who heads the Children’s Environmental Health Center at Mount Sinai School of Medicine in New York, said the phrase third-hand smoke is a brand-new term that has implications for behavior.

Among the substances in third-hand smoke are hydrogen cyanide, used in chemical weapons; butane, which is used in lighter fluid; toluene, found in paint thinners; arsenic; lead; carbon monoxide; and even polonium-210, the highly radioactive carcinogen that was used to murder former Russian spy Alexander V. Litvinenko in 2006. Eleven of the compounds are highly carcinogenic.

January 3, 2009 | Permalink | Comments (0) | TrackBack (0)

Friday, January 2, 2009

Good-Bye to the Drug Company Freebies

The New York Times reports on the voluntary moratorium on free pens, notepads etc. from drug companies.  It states,

Starting Jan. 1, the pharmaceutical industry has agreed to a voluntary moratorium on the kind of branded  goodies  — Viagra pens, Zoloft soap dispensers, Lipitor mugs — that were meant  to foster good will and, some would say, encourage doctors to prescribe more of the drugs. . . .

Some skeptics deride the voluntary ban as a superficial measure that does nothing to curb the far larger amounts drug companies spend each year on various other efforts to influence physicians. But proponents welcome it as a step toward ending the barrage of drug brands and logos that surround, and may subliminally influence, doctors and patients. . . .

The new voluntary industry guidelines try to counter the impression that gifts to doctors are intended to unduly influence medicine. The code, drawn up by Pharmaceutical Research and Manufacturers of America, an industry group in Washington, bars drug companies from giving doctors branded pens, staplers, flash drives, paperweights, calculators and the like.

The guidelines also reiterate the group’s 2002 code, which prohibited more expensive goods and services like tickets to professional sports games and junkets to resorts. And it asks companies that finance medical courses, conferences or scholarships to leave the selection of study material and scholarship recipients to outside program coordinators.

Diane Bieri, the executive vice president of Pharmaceutical Research and Manufacturers of America, said the updated guidelines were not an admission that gifts could influence doctors’ prescribing habits. Instead, she said, they were meant to emphasize the educational nature of the relationship between industry and doctors. . . .

But some critics said the code did not go far enough to address the influence of drug marketing on the practice of medicine. The guidelines, for example, still permit drug makers to underwrite free lunches for doctors and their staffs or to sponsor dinners for doctors at restaurants, as long as the meals are accompanied by educational presentations. . . .

About 40 drug makers, including Eli Lilly & Company, Johnson & Johnson and Pfizer, have signed on to the code. Representatives of several pharmaceutical makers said their companies intended to comply with the guidelines, but they declined to discuss past marketing programs involving branded gifts.

The restrictions come as a blow to the makers and distributors of promotional products, an industry with an annual turnover of about $19 billion, according to Promotional Products Association International, a trade group. Such companies, accustomed to orders of up to a million pens a drug, stand to lose around $1 billion a year in sales as a result of the drug industry’s voluntary ban, the group said. . . .

January 2, 2009 | Permalink | Comments (0) | TrackBack (0)

New Animals Helping the Disabled

The New York Times reports on the new types of animals helping the disabled and the controversy surrounding accommodating individuals who use guide animals other than the canine variety.  The article states,

On Halloween night in a suburb of Albany, a group of children dressed as vampires and witches ran past a middle-aged woman in plain clothes. She gripped a leather harness — like the kind used for Seeing Eye dogs — which was attached to a small, fuzzy black-and-white horse barely tall enough to reach the woman’s hip. “Cool costume,” one of the kids said, nodding toward her.  But she wasn’t dressed up. The woman, Ann Edie, was simply blind and out for an evening walk with Panda, her guide miniature horse.

There are no sidewalks in Edie’s neighborhood, so Panda led her along the street’s edge, maneuvering around drainage ditches, mailboxes and bags of raked leaves. At one point, Panda paused, waited for a car to pass, then veered into the road to avoid a group of children running toward them swinging glow sticks. She led Edie onto a lawn so she wouldn’t hit her head on the side mirror of a parked van, then to a traffic pole at a busy intersection, where she stopped and tapped her hoof. “Find the button,” Edie said. Panda raised her head inches from the pole so Edie could run her hand along Panda’s nose to find and press the “walk” signal button.

Edie isn’t the only blind person who uses a guide horse instead of a dog — there’s actually a Guide Horse Foundation that’s been around nearly a decade. The obvious question is, Why? In fact, Edie says, there are many reasons: miniature horses are mild-mannered, trainable and less threatening than large dogs. They’re naturally cautious and have exceptional vision, with eyes set far apart for nearly 360-degree range. Plus, they’re herd animals, so they instinctively synchronize their movements with others. But the biggest reason is age: miniature horses can live and work for more than 30 years. In that time, a blind person typically goes through five to seven guide dogs. That can be draining both emotionally and economically, because each one can cost up to $60,000 to breed, train and place in a home. . . .

What’s most striking about Edie and Panda is that after the initial shock of seeing a horse walk into a cafe, or ride in a car, watching them work together makes the idea of guide miniature horses seem utterly logical. Even normal. So normal, in fact, that people often find it hard to believe that the United States government is considering a proposal that would force Edie and many others like her to stop using their service animals. But that’s precisely what’s happening, because a growing number of people believe the world of service animals has gotten out of control: first it was guide dogs for the blind; now it’s monkeys for quadriplegia and agoraphobia, guide miniature horses, a goat for muscular dystrophy, a parrot for psychosis and any number of animals for anxiety, including cats, ferrets, pigs, at least one iguana and a duck. They’re all showing up in stores and in restaurants, which is perfectly legal because the Americans With Disabilities Act (A.D.A.) requires that service animals be allowed wherever their owners want to go.

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January 2, 2009 | Permalink | Comments (0) | TrackBack (0)

Thursday, January 1, 2009

Happy 2009!

Fireworks Hope that you and your loved ones have a wonderful 2009! 

January 1, 2009 | Permalink | Comments (0) | TrackBack (0)

Drug Companies and Doctors

Marcia Angell has a new article in the New York Times Review of Books.  She reviews three recent books concerning the relationship between drug companies and doctors.  The books are:

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial          

by Alison Bass     

Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs           

by Melody Petersen

Shyness: How Normal Behavior Became a Sickness           

by Christopher Lane

She writes,

Recently Senator Charles Grassley, ranking Republican on the Senate Finance Committee, has been looking into financial ties between the pharmaceutical industry and the academic physicians who largely determine the market value of prescription drugs. He hasn't had to look very hard.

Take the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard's Massachusetts General Hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age.

Legally, physicians may use drugs that have already been approved for a particular purpose for any other purpose they choose, but such use should be based on good published scientific evidence. That seems not to be the case here. Biederman's own studies of the drugs he advocates to treat childhood bipolar disorder were, as The New York Times summarized the opinions of its expert sources, "so small and loosely designed that they were largely inconclusive."[1]

In June, Senator Grassley revealed that drug companies, including those that make drugs he advocates for childhood bipolar disorder, had paid Biederman $1.6 million in consulting and speaking fees between 2000 and 2007. Two of his colleagues received similar amounts. After the revelation, the president of the Massachusetts General Hospital and the chairman of its physician organization sent a letter to the hospital's physicians expressing not shock over the enormity of the conflicts of interest, but sympathy for the beneficiaries: "We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them." . . .

No one knows the total amount provided by drug companies to physicians, but I estimate from the annual reports of the top nine US drug companies that it comes to tens of billions of dollars a year. By such means, the pharmaceutical industry has gained enormous control over how doctors evaluate and use its own products. Its extensive ties to physicians, particularly senior faculty at prestigious medical schools, affect the results of research, the way medicine is practiced, and even the definition of what constitutes a disease.

Her reviews of these books are in-depth and thought-provoking.  They are books to add to the year's reading list.  Ezra Klein has some further thoughts on the reviews as well.

January 1, 2009 | Permalink | Comments (0) | TrackBack (0)

Wednesday, December 31, 2008

Genetic Testing: People Not Ready for Unclear Results

Genes National Public Radio's All Things Considered had a short story on a family who decided to have some genetic testing completed after a loved one died of cancer.  The results were not quite what they expected.  Here is an excerpt from the show,

"Information is power," has become a common mantra. But for many people seeking answers through genetic testing, all the DNA probing ends in this twist: Less certainty, not more.  This sometimes leads to tough personal decisions amid ambiguity. Nashville novelist Susan Gregg Gilmore learned this lesson the hard way.

Gilmore, a happily married, 47-year-old mother of three daughters, sought testing for flaws in two long genes known as BRCA 1 and BRCA 2. A number of mutations in those genes, first identified in the mid-1990s, have been strongly associated with an increased risk of breast and ovarian cancers.

The risk is particularly elevated for women; having one of the harmful mutations increases the lifetime risk of breast cancer to somewhere between 36 percent and 85 percent, according to the National Cancer Institute. The range reflects the differing risk estimates that have turned up in different studies. A BRCA mutation increases the ovarian cancer risk to between 16 percent and 60 percent.

Though she had heard of the test, Gilmore says, she never thought much about it before getting a call from her mother-in-law, Martha, a few years ago. Eighteen months after defeating breast cancer, Martha Gilmore, a Methodist minister, was diagnosed with ovarian cancer, at age 63. Though most cases of breast and ovarian cancer are not inherited, Martha and her doctors wondered if a BRCA mutation might be behind both diseases in her case. She had called to tell Susan that she was considering taking the test so that her children and grandchildren would have more information. . . .

Martha did turn out to have one of the mutations in BRCA 1 that's been tied to cancer. Eventually, she died of the illness, with Susan and other family members at her bedside. And not long after Martha's funeral, further testing showed that her son Dan Gilmore — Susan's husband — had also inherited the mutation. . . .

. . . she decided, would be to get tested herself for BRCA mutations. It would put her mind at rest, and give her daughters "a more complete medical history on both sides of our family." Susan's mother is still alive and healthy, and Susan has lots of middle-aged female cousins and sisters who are all cancer-free. The doctors told her it was extremely unlikely she had a BRCA mutation. All the more reason to get tested, she thought. . . .   

Susan and her family had been counting on good news — or at least a clear thumbs up or thumbs down. But, as the counselor explained, a variant mutation of "undetermined significance" turns up in roughly 10 percent of all case of BRCA tests, and even more often among African-American families. It means there is definitely a mutation, but one that hasn't been linked to illness, in all the research that's been done so far. Susan's "variant" could turn out to be harmless … or not. At this point, no one can say for sure. . . .

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December 31, 2008 | Permalink | Comments (0) | TrackBack (0)

Calories v. Nutrition

Fruit The Washington Post reports on the new direction food assistance programs may take under the Obama administration.  The article states,

The worsening economic crunch is causing the tab for food assistance programs to balloon, and with the rising costs has come an intensifying debate over whether -- and how -- the U.S. government can tackle simultaneously the paradoxically linked problems of hunger and obesity.

The statistics spell out the dilemma. The number of Americans on food stamps topped 31.5 million in September, a record high. Obesity, too, is at epidemic levels: In 30 states, at least 25 percent of the population is dangerously overweight. Nationally, 31.9 percent of children are considered overweight or obese.

For decades, the government has treated hunger and obesity as unrelated phenomena. But at a news conference last week in Chicago, Tom Vilsack, President-elect Barack Obama's choice for agriculture secretary, said he would put "nutrition at the center of all food assistance programs," a signal that he will get involved next year when Congress moves to reauthorize nutrition programs that support school breakfasts and lunches as well as summer food for children.  "For a long time, we've looked at hunger and obesity separately," said  Sen. Tom Harkin (D-Iowa), chairman of the committee that will draft the legislation. "It's not a zero-sum game."

Public health advocates have long hoped to link food assistance to good nutrition. To the anti-hunger lobby, however, mandating what kind of food needy people should eat is impractical and smacks of paternalism. It would be impossible, they say, to determine which of the 50,000-plus products in the grocery store should be classified as healthful. . . .

But with hunger and obesity reaching unprecedented levels, some anti-hunger activists are beginning to soften their stance. According to a report by the Partnership for America's Economic Success, toddlers whose families have gone hungry are three to four times as likely to be obese. If the current recession resembles past downturns, the independent Center on Budget and Policy Priorities predicts, the number of Americans in poverty could rise by as many as 10 million, driving up obesity, diabetes and cardiovascular disease. . . .

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December 31, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, December 30, 2008

Health Care Rationing Editorial

The Wall Street Journal has an article by Sally C. Pipes about the potential for rationing of health care under an Obama Administration.  She writes,

People are policy. And now that President-elect Barack Obama has fielded his team of Tom Daschle as secretary of Health and Human Services and Melody Barnes as director of the White House Domestic Policy Council, we can predict both the strategy and substance of the new administration's health-care reform.

The prognosis is not good for patients, physicians or taxpayers. If Mr. Daschle meant what he wrote in his book "Critical: What We Can Do About the Health-Care Crisis," Americans can expect a quick, hard push to build more federal bureaucracy, impose price controls, restrict medicines and technology, boost taxes, mandate the purchase of health insurance, and expand government health care.

In his book, Mr. Daschle proposes a National Health Board to regulate the way health care is provided. This board would have vast powers in regulating the massive federal health-care system -- a system that includes Medicare, Medicaid, and other programs. Under Mr. Obama, it is likely that that system will be expanded and that new government insurance for the nonelderly, nonpoor will be created.

Given the opportunity, Mr. Daschle would likely charge the board with determining which treatments and drugs are cost effective and therefore permissible to use for patients covered by the government. And because the government is such a big player in the health-care market (46% of health-care spending comes from the government), the board would effectively set parameters for private insurers.

It is nearly certain that the process of determining which drugs and which treatments would be approved for use would be quickly politicized. The details of health-care policy may not be kitchen table conversation, but the fact that a Washington committee can deny grandma a hip replacement due to her age, or your sister a new and expensive drug, is. Health care is personal and voters will pressure lawmakers on access to care. . . .

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December 30, 2008 | Permalink | Comments (0) | TrackBack (0)

Pill-Cutting and Medical Care Saving Attempts

Pills Daily Kos has a story on people trying to save money by extending the life of their medications.  Turns out not to be a good idea.  Jed L links to a recent MSNBC story and  writes,

As far back as October, the Kaiser Health Foundation found that almost half the people in the country had somebody in their family who was skimping on medical care to save money:

Nearly half (47%) of the public reports someone in their family skipping pills, postponing  or cutting back on medical care they said they needed in the past year due to the cost of care.  For example, just over one-third say they or a family member put off or postponed needed care and three in ten say they skipped a recommended test or treatment – increases of seven percentage points from last April’s tracking poll which asks the same question.

. . .  It's a clear demonstration of the downside of allowing drug manufacturers to charge ever-higher sums for medicine, and it's just another reason why the Obama team is correct to make health care an important component of their stimulus plan.

December 30, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, December 29, 2008

Biology in your Garage??

The NewsHour had an interesting story about people taking biology into their own hands and making up synthetic organisms in their labs.  The NewsHour covered this development as an overall good but I do have some concerns about people making things in their garages that could be released with unfortunate results for all of us.  Anyway, it is an interesting development that seems to have quite a bit of support.

December 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Massachusetts Health - Model Reform??

Charlie Baker at HealthCareBlog provides a critique of the Massachusetts health reform plan and whether it will serve as a model for the rest of the nation.  He writes about whether Massachusetts can serve as a model when there are quite a few differences between health insurance there and elsewhere.  His article states, 

. . . . There were profound differences between Massachusetts and the rest of the country before health care reform took center stage here that make relying on our experience somewhat challenging for the nation as a whole. For example, Massachusetts already had guaranteed-issue requirements for individual health insurance coverage even before reform. Today, most states don’t. So in Massachusetts, individual coverage was available to anyone who wanted to buy it, but it was really, really expensive.

That’s because most of the people who buy individual coverage -- absent a mandate to purchase -- usually plan to use health care services once they purchase the insurance. Insurance works through risk pooling - a small number of people who get sick spend the premiums paid by a much larger group of people who don’t.  If most of the people who buy the product plan to use it, there’s not enough healthy people to keep the overall price down.

When the state merged the individual health insurance market with the small group health insurance market (businesses with 1-50 employees) as part of its reform efforts, prices for individual coverage went down by 25 percent (on a per capita basis, individuals spend a lot more on health care than small business employees - hence the big drop in price for the individuals when they got mushed together with all the small business employees).  At the same time, small group prices went up by 2 percent to pay for including the cost of all those individual purchasers in their risk pool. This was mostly missed during the implementation of reform, because medical expense trends went up by 10% over the same period of time, shielding the shift in expenses from individuals to small group.

In addition, most other states permit medically underwritten individual insurance - which weeds out people seeking to purchase coverage who might be high risk enrollees. They either get denied coverage, or shifted to a high risk pool for high risk enrollees. As a result, individual insurance in many states is very, very inexpensive for those who can access and purchase coverage.  Any national move to guarantee issue individual coverage - even with a mandate to buy - virtually assures that these people - and there are millions of them throughout the country - will pay a lot more for their health insurance coverage than they pay now. This is exactly the opposite of what happened when reform was passed in Massachusetts, and needless to say, this would make all those folks who have individual insurance now very unhappy.

Massachusetts also heavily regulated the small group health insurance market before reform, using rating  rules that capped how far apart the prices for expensive and inexpensive (relatively speaking) products could be, and prohibiting medical underwriting in the small group market. Today, most states allow significantly more flexibility than MA did before reform, and the MA rules today are even more restrictive than they were before reform. . . .

Third, Massachusetts had a declining population, a tight labor market, high per capita income, and relatively rich plan designs in its public and private health insurance programs to begin with. Our unemployment rate has been below the national average for the past couple of years, but not because we’ve been creating new jobs faster than the nation overall. It’s because our working population has been shrinking for years, making it easier for the state’s economy to appear to be relatively healthy compared to its peers. . .

Fourth, state government was already making significant - and calculable - investments in paying for hospital-based services provided to people in Massachusetts who did not have insurance. It was worth about $1 billion, and was funded by a combination of assessments on health plans and providers, money from the state itself, and federal reimbursements through a Medicaid waiver. There is no calculation anywhere at the national level that could possibly help people understand what the “savings” from getting everyone covered might be to the system overall. Moreover, because Massachusetts already had so much money “in the game” so to speak, the Commonwealth did not have to raise taxes (much) to make the prospect of universal coverage a reality. I would think this trick will be much harder to pull off at the federal level.

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December 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Sunday, December 28, 2008

Cuts in Medicaid

The Washington Post reports on the latest in rather horrific cuts in Medicaid - just as the economy seems to be falling even further into deep recession.  The Post story provides,

States from Rhode Island to California are being forced to curtail Medicaid, the government health insurance program for the poor, as they struggle to cope with the deteriorating economy. With revenue falling at the same time that more people are losing their jobs and private health coverage, states already have pared their programs and many are looking at deeper cuts for the coming year. Already, 19 states -- including Maryland and Virginia -- and the District of Columbia have lowered payments to hospitals and nursing homes, eliminated coverage for some treatments, and forced some recipients out of the insurance program completely.

Many are halting payments for health-care services not required by the federal government, such as physical therapy, eyeglasses, hearing aids and hospice care. A few states are requiring poor patients to chip in more toward their care.. . .

Medicaid, a central piece of the Great Society safety net created in the 1960s, is the nation's largest source of government health insurance. It covered 50 million Americans last year. The program is a shared responsibility of the federal government and the states, with federal money paying an average of 57 percent of the bills and states providing the rest. Federal health officials set minimum rules about who can enroll and what care must be covered, but states are free to add to the basics. Those optional patients and services are what many states are rethinking now.

With the program the largest or second-largest expense in every state's budget, governors and state legislators have been pleading with Congress and the incoming Obama administration for help. The Democrats, who hold majorities in the House and the Senate, are sounding sympathetic for now. They are considering close to $100 billion to increase the share of Medicaid's costs that the federal government would pay during the next two years.

President-elect Barack Obama also is open to extra help for Medicaid as part of a broad strategy to spur the economy. "We are considering a number of proposals . . . including helping states meet Medicaid needs; reducing health-care costs; rebuilding our crumbling roads, bridges and schools; and ensuring that more families can stay in their homes," said Nick Shapiro, an Obama transition spokesman.  According to a Washington source who is in close contact with lawmakers, some in Congress also are beginning to entertain the idea of allowing unemployed people who have lost health benefits to sign up for Medicaid, with federal money paying the entire bill. . . .

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December 28, 2008 | Permalink | Comments (0) | TrackBack (0)