Apples and Fries: The New Look of McDonald’s Happy Meals (Toys Still Included)

Responding to pressure from parents and consumer groups, McDonald’s announced on Tuesday its “Commitments to Offer Improved Nutrition Choices” and serve up more nutritionally-balanced meal options, particularly for children.  Starting in September, Happy Meals will have apple slices and a smaller serving of French Fries (1.1 ounces instead of 2.4 ounces).  The company stated that “[b]y adding fruit in every Happy Meal, McDonald’s hopes to address a challenge children face in meeting the recommended daily consumption of produce” and noted that “[f]or those customers who prefer a side choice of apples only, two bags of apple slices will be available, upon request.”   McDonald’s vice president Ben Stringfellow has said that the company is considering other fruit choices such as “pineapple spears, raisins and carrot sticks.”  Other planned  changes in the next year include a 10% sodium reduction in chicken products, new beverage options of fat-free chocolate milk and 1% low fat white milk (in addition to the traditional sodas),  and increased access to nutrition information through mobile apps for iPhone, iPad, Blackberry, and Android devices.

Once the nutritional changes take effect, a Happy Meal with chicken nuggets will shrink from 530 calories and 23 grams of fat to 435 calories and 17 grams of fat.  Samantha Graff, director of legal research at Public Health Law and Policy, told Prescriptions, The New York Times health blog, that “McDonald’s has taken an extremely important step to help parents who want to please their kids while providing them with at least minimally nutritious food. We think it’s a terrific move.”  In an opinion piece, Chris Woolston, a writer for Booster Shots, the Los Angeles Times health blog, wonders whether healthier McDonald’s meals are the answer as

[t]o reshape their kids’ diets, parents need to make more meals at home, where they can write the menus and control the ingredients and portion sizes. If more healthful Happy Meals translate into more trips to the golden arches — as McDonald’s obviously hopes — the end result may be something other than happiness.

Sure, for companies like McDonald’s, it’s about the bottom line.  For parents, it’s about the health of their children.  Good, responsible eating does start in the home… but why let it end there?

(Click on these links for two posts from Booster Shots on calorie labeling and the push among health experts for a public calorie database.)

Take Them Away: Has Severe Childhood Obesity Really Come to This?

As a follow up to my previous post on junk food marketing to children and my earlier post on MyPlate — and any other post that I’ve written about children and fast food or junk food — I would like to direct your attention to a commentary recently published in the Journal of the American Medical Association which has caused quite a stir.  In “State Intervention in Life-Threatening Childhood Obesity,” Dr. David Ludwig (Director of the Optimal Weight for Life Program at Children’s Hospital in Boston, Massachusetts) and lawyer Lindsey Murtagh (Research Associate for the Department of Health Policy and Management at Harvard School of Public Health) confront severe childhood obesity — which is “characterized by a body mass index (BMI) at or beyond the 99th percentile” — with what appears to be a wild and rash line of thought: remove severely obese children from their homes and place them into foster care.

In their commentary, Dr. Ludwig and Ms. Murtagh write that

[s]tate intervention may serve the best interests of many children with life-threatening obesity, comprising the only realistic way to control harmful behaviors. Child protective services typically provide intermediate options such as in-home social supports, parenting training, counseling, and financial assistance, that may address underlying problems without resorting to removal. These less burdensome forms of legal intervention may be sufficient and therefore preferable in many cases. In some instances, support services may be insufficient to prevent severe harm, leaving foster care or bariatric surgery as the only alternatives. Although removal of the child from the home can cause families great emotional pain, this option lacks the physical risks of bariatric surgery.

However, the authors also acknowledge that

removal from the home does not guarantee improved physical health, and substantial psychosocial morbidity may ensue. Thus, the decision to pursue this option must be guided by carefully defined criteria… with less intrusive methods used whenever possible.

Reading through the commentary, one senses an exasperated tone more than anything else.  After all, the authors cite a mind-numbing statistic: there are approximately 2 million severely obese children in the United States.  And how should we treat this epidemic?  With bariatric surgery you say?  And so the authors wonder aloud whether “removal from the home may be justifiable from a legal standpoint because of imminent health risks and the parents’ chronic failure to address medical problems.”

Let’s set aside the legal arguments for a minute and discuss the heart of the matter: America’s eating habits.  Specifically, America’s childrens’ eating habits.   In a response post on MSNBC, Arthur Caplan, Director of the Center for Bioethics at the University of Pennsylvania, criticized Dr. Ludwig and Ms. Murtagh by focusing on other obesity-causing factors, such as the unhealthy “food culture,” that pervades the United States.  Professor Caplan wrote

I am not letting parents off the hook. But, putting the blame for childhood obesity on the home and then arguing that moving kids out of homes where obesity reigns is the answer is short-sighted and doomed to fail. We need the nation to go on a diet together and the most important places to start are at the grocery store, schools and media.

On Booster Shots, the Los Angeles Times health blog, Chris Woolston wrote that removing children from their homes and placing them into foster care will not fix poor eating habits because

[c]hildhood obesity is complicated. Fast food, sodas, TV, video games — many staples of modern life are pushing kids in the wrong direction. While researching a book on this topic a few years ago, I spoke with several moms who were tackling their child’s weight troubles with varying levels of success. One considered putting locks on her cabinets to keep her son from sneaking food in the middle of the night.

Her son was definitely on the large side — beyond that, really — but it’s not because his mom didn’t care. And even if someone had placed him in a foster home it wouldn’t have solved his problems. As a rule, those places have food in their cupboards, too.

Hear, hear.  Wake up, folks.  We need a food culture revolution with healthier and affordable alternatives.  One which teaches our children to choose healthy foods and to eat in moderation.  Because what else must we do before everyone finally, in the words of Professor Caplan, “[d]emonize[s] the companies that sell and market food that is not nutritious” and “[p]ut[s] exercise back on the menu for all school kids”?  Institute state programs that remove severely obese children from their homes and place them into foster care?  Oh, wait….

The Junk Food Marketing Debate: A First Amendment Right or Just Making Sure Kids Aren’t What They Eat?

Remember the Omnibus Appropriations Act of 2009 (H.R. 1105) that President Obama signed on March 11, 2009?   No?  Good, me neither, but my excuse is that I was busy applying to law schools.  If you and I had been paying closer/any (take your pick) attention, we would have seen that the Act included, among other things, a provision calling for the Federal Trade Commission, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Department of Agriculture to create an Interagency Working Group on Marketed Food to Children (“Working Group”) composed of representatives from each agency.  The Working Group would research and recommend standards for the marketing and advertising of food to children age 17 years and younger.   These recommendations would be presented to Congress down the road.

Well, a couple of years passed, but in April 2011 the Working Group released its 26-page “Preliminary Proposed Nutrition Principles to Guide Industry Self-Regulatory Efforts” for public comment (which you can submit by clicking here before July 14). The Working Group notes that

… in the FTC’s 2008 study on Marketing Food to Children and Adolescents, three food categories — breakfast cereal, restaurant foods, and snack foods — represented approximately 70% of food marketing expenditures directed to children under 12. Similarly, three categories of foods — carbonated beverages, restaurant foods, and non-carbonated beverages — represented 69% of the food marketing expenditures for adolescents ages 12-17 year….  [Overall] [t]he categories most heavily marketed to children and adolescents, ages 2 -17 years are: breakfast cereals; snack foods; candy; dairy products; baked goods; carbonated beverages; fruit juice and non-carbonated beverages; prepared foods and meals; frozen and chilled deserts; and restaurant foods. The Working Group is therefore recommending that the food industry focus its efforts on ensuring that any advertising or marketing of food products within these ten categories meet the nutrition principles set out below. (Emphasis added.)

The Working Group focuses on two nutritional principles “that both improve the nutritional quality of foods marketed to children and can be feasibly implemented by industry with sufficient time to accomplish reformulation,” namely, “Meaningful Contribution to a Healthful Diet” (Principle A)  and “Nutrients with Negative Impact on Health or Weight”  (Principle B).  Principle A ensures that foods marketed to children contain two or more of the following food groups: “fruit, vegetable, whole grain, fat-free or low-fat milk products, fish, extra lean meat or poultry, eggs, nuts and seeds, or beans.”  Principle B ensures that foods marketed to children have limited amounts of saturated fat, trans fat, sodium, and added sugars.  The Working Group makes sure to point out (several times in fact) that its recommendation are based on the 2010 Dietary Guidelines for Americans.

Really, this all sounds quite sensible, if not a little over-protective… but considering, as The Washington Post has reported, that Type 2 diabetes has significantly increased among people age 20 years and younger, what else can this country do to curb obesity and poor eating habits?  Even if we could reduce the cost of nutrient-rich and quality foods so that everyone could afford them, how do we neutralize the marketing of junk food to children?  In a report last month, NPR noted how

[the Working Group] broke from the past by seeking to include 12- to 17-year-olds in its guidelines. Traditionally, limits on marketing focused on the very young. But the government sought to expand them to older children, in part because they are heavy consumers of social media, cell phone messages and online games — the new frontier for ads.

That new frontier of advertising to children through online games — also known as “advergaming” (forgive my use of Wikipedia but Merriam-Webster doesn’t list the word) — includes Asylum 626 and Hotel 626, two advergames sponsored by Doritos.  As NPR reported,

“[w]hat we’re talking about are very complicated and very subtle forms of marketing that aren’t always clear as such,” says Kathryn Montgomery, a professor of communications at American University and an advocate for limiting food ads to teens.

[...]

Montgomery says such ads work subliminally and use friends to influence other friends.

But efforts to restrict ads to teens draw lots of opposition from the food and advertising industries. The industries say the overlap between teen and adult audiences makes the proposed restrictions impractical.

Critics, including the U.S. Chamber of Commerce, have questioned the constitutionality and logic of the Working Group’s nutritional proposals.  The Hill’s Healthwatch has reported that some critics see a First Amendment issue because

“[w]hat they’re doing is trying to simultaneously … suppress speech, while insulating it from judicial review,” said Northwestern law Professor Martin Redish, one of the panelists at a Chamber of Commerce discussion Thursday. “Because if these regulations were truly just advisory, there would be no case or controversy.”

[...]

“Industry’s rights are being violated here,” Redish said, “but there’s something deeper and darker that’s going on: The government is treating us like sheep.”

While constrained to commercial speech, Redish said that attitude has broader implications. People, he said, “can’t be sheep in the commercial realm and then all of a sudden, in the political realm, they’re free-thinking adults who can make basic choices.”

NPR has reported that other critics question the logic behind the proposal and the implicated age range.

Elaine Kolish directs an industry-funded program called the Children’s Food and Beverage Advertising Initiative. For the past five years this initiative sponsored its own voluntary standards that focus only on the 12-and-under set.

“You know, we let kids drive and we let them hold jobs when they’re 16. They can get married in some states, and they can join the military with permission, and they can be held criminally responsible for their actions in a number of situations,” she says. “So I think that the notion that you’d have to have nutrition standards that say you can’t let a kid see an ad for a french fry but you can let them join the military doesn’t really make a lot of sense.”

So where do we go from here?  Is industry self-regulation the answer to making products that better fit on MyPlate?  As I’ve noted in a previous post about McDonald’s Happy Meal toys, sometimes the answer can be stricter parenting (just say “no”).  Yet how can parents instill and maintain healthy eating habits in their kids when advertisements for unhealthy food bombard them through television, social media, and online games?

A Pyramid No More: You Are A Plate of Quadrants and A Dairy Circle

Step aside, food pyramid, there’s a new dietary guide in town: MyPlate.  During a press conference on Thursday, First Lady Michelle Obama and Department of Agriculture Secretary Tom Vilsack released MyPlate –whose color-coded quadrants of fruits, vegetables, grains, and protein — plus dairy circle — are intended to serve as “a quick, simple reminder for all of us to be more mindful of the foods that we’re eating.”  MyPlate replaces the 2005 MyPyramid and the 1992 “old school” USDA Food Pyramid, both of which have been criticized as misleading or difficult to understand (I dare say that the MyPyramid color scheme was a little reminiscent of a similarly confusing color-coded federal government alert system).  MyPlate complements the federal government’s 2010 Dietary Guidelines for Americans, released earlier this year, which reminds consumers about:

Balancing Calories

• Enjoy your food, but eat less.
• Avoid oversized portions.

Foods to Increase

• Make half your plate fruits and vegetables.
• Make at least half your grains whole grains.
• Switch to fat-free or low-fat (1%) milk.

Foods to Reduce

• Compare sodium in foods like soup, bread, and frozen meals — and choose the foods with lower numbers.
• Drink water instead of sugary drinks.

MyPlate is meant to be an “easy-to-understand visual cue.”  Among the noticeable changes to the food guide are the absence of the “fats, oils, & sweets” section which once sat atop the 1992 food pyramid and the relabeling of the 2005 MyPyramid sections of “milk” to “dairy” and “meat and beans” to “protein.”  The AP reports that

[t]he guidelines and the icon were subject of lobbying by food industries who want to see their products promoted and not discouraged. Fruit and vegetable growers were celebrating their victory over half of the plate Thursday, while dairy producers said they were also pleased with the cup beside it. The president of the beef industry group National Cattleman’s Beef Associaton, Bill Donald, said he is not concerned about the elimination of the word “meat” because beef is so associated with the word “protein.”

According to the New York Times, MyPlate is the brainchild of the Department of Agriculture, the First Lady’s Child Obesity Task Force, and other federal health officials.  During the press conference, First Lady Obama noted that

[w]hen mom or dad comes home from a long day of work, we’re already asked to be a chef, a referee, a cleaning crew. So it’s tough to be a nutritionist, too. But we do have time to take a look at our kids’ plates. As long as they’re half full of fruits and vegetables, and paired with lean proteins, whole grains and low-fat dairy, we’re golden. That’s how easy it is.

Nutritionists cautiously welcomed MyPlate.  For instance, Marion Nestle, a New York University professor, told the New York Times that

“[i]t’s better than the pyramid, but that’s not saying a lot”….

Dr. Nestle praised the plate for being generally easy to understand, but she said that labeling a large section of the plate “protein” was confusing and unnecessary, because grains and dairy products also are important sources of protein and most Americans get far more protein than they need.

But she said the emphasis on fruits and vegetables was a significant step.

Dawn Jackson Blatner, a registered dietician in Chicago, told The Wall Street Journal Health Blog that “we went from something that was complex and hard for people to remember to something that is very visual, clear and based in science. People don’t eat off a pyramid, they eat off a plate.”  Except maybe for the people who designed the original food pyramid.

It’s early days yet, folks, but I agree with Ms. Blatner.  At least the food guide finally looks more like my dinner plate and less like a jumble of colors and pyramidal fragments.  Be sure to click here for an article from the Los Angeles Times to learn how other countries have visualized their food guides.

Discount Prescription Program Available To Some Locals

Listen up, Hoboken, Newark, and Orange residents.  There’s a new prescription discount program in town: Coast2Coast Rx Card.  Well, the program isn’t all that new to the area: Newark launched it last year and Hoboken launched it in January.  However, I didn’t learn about Coast2Coast Rx Card until I filled a prescription at my local CVS last month.  Since my prescription wasn’t covered by my health insurance (I always joke to the pharmacist that it kind of defeats the purpose of having health insurance, but I never get any laughs), I was bracing myself for the out-of-pocket cost.  So imagine my surprise when the pharmacist said that I owed $35 instead of $50.  When I pointed out the “mistake,” I was handed a Coast2Coast Rx Card.

While it isn’t a substitute for health insurance, the free Card does offer discounts on prescription drugs, laboratory tests, and imaging tests.  Specifically, the Card boasts such features as:

• 59,000+ participating pharmacies including all major chains and most independents
• Over 60,000 drugs included in formulary
• Save up to 65% on a brand name or generic drugs
• Overall annual savings range from 30% to 45%
• Card is good for an entire family
• Cardholder pays no fees for the card
• No paperwork to fill out — card is ready to use
• There are no health, age or income restrictions; everyone qualifies
• Card has no expiration date and can be used as often as needed
• Card can be used to fill pet prescriptions at participating pharmacies
• Card is primarily for uninsured although insureds can use the card if they have a high deductible
• Insureds can use the card if their drug isn’t covered by their insurance
• In some instances the card can be used during the Medicare Part D “donut hole.”
• Cardholder information is held confidential and is not used for any other purpose.
• The card includes 50%-80% discounts on lab and imaging tests

According to The Florida Times-Union, Financial Marketing Concepts, Inc. (FMC), a Florida-based company, issues the Card on behalf of WellDyneRx, a national pharmacy benefit management company.  In the past three years, FMC has secured agreements with 57 cities and counties in Alabama, Arizona, California, Florida, Illinois, Massachusetts, Mississippi, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Texas (which may or may not look something like this.)  These agreements give FMC a small fee for each prescription filled through the program.  FMC in turn passes along a royalty to the city or county.

If you’re like me, you may already be in the habit of calling pharmacies and comparing the cost of prescriptions, regardless of whether or not your health insurance covers them — and it’s surprising how the cost can vary.  So if you live in Hoboken, Newark, or Orange, be sure to check out whether the Card gives you any discounts.  Can’t hurt.

This Film is Rated “R” for… Smoking?

Earlier this month, the Wall Street Journal Health Blog reported on several anti-smoking groups waging a campaign against Rango, a Paramount Pictures animation about animal characters in a Wild West town.  In one scene, a character swallows a cigar and burps fire into the face of another character.  Seemingly harmless fun in the world of animation, right?  Well, not everyone thinks so… and the burping fire and possible physical scarring isn’t the issue here.

Smoke Free Movies, the American Legacy Foundation, the Campaign for Tobacco-Free Kids, and the American Academy for Pediatrics have rallied against the portrayal of smoking in Rango and other films marketed to children.  (SceneSmoking provides a tally of the number of “smoking incidents” – over 50 – in Rango.)  The groups maintain that exposing children to smoking on the silver screen leads to smoking in real life; thus, such films should have an R-rating.  Rango is rated PG “for rude humor, language, action, and smoking.”

In response to the release of Rango, Cheryl Healton, CEO of the American Legacy Foundation, stated that

[t]he public health community has made great progress in making every studio aware of the harm to America’s youth when they release films with smoking and animated films are no exception….  Even the cartoon Joe Camel has long been barred from reaching children to sell cigarettes. So it is a mystery why Hollywood’s masters of storytelling and visual effects have not found a better way to depict their characters without the danger of influencing young people to light up.

Similarly, Smoke Free Movies took out a one-page advert in Variety and The Hollywood Reporter criticizing Paramount Pictures and the film industry for the depiction of tobacco use in Oscar-nominated films and citing National Cancer Institute research connecting silver screen exposure to an increased likelihood of real-life smoking.  Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California-San Francisco (and head of Smoke Free Movies), said “[a] lot of kids are going to start smoking because of this movie.”  On the other side, Virginia Lam, a Paramount Pictures spokeswoman, replied that “[t]he images of smoking in the film, which primarily involves the animals, are portrayed by supporting characters and are not intended to be celebrated or emulated. Rango [the title character] is never depicted as smoking.”

So are these anti-smoking groups overreacting or must the Motion Picture Association of America (MPAA) reevaluate its ratings system?  In August 2010, the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report printed some research that found “[e]xposure to onscreen smoking in movies increases the probability that youths will start smoking.  Youths who are heavily exposed to onscreen smoking are approximately two to three times more likely to begin smoking than youths who are lightly exposed.”  (Note Prof. Glantz contributed to that report.)  USAToday has reported that “[o]f more than 2,500 movies rated from May 2007 to May 2010, nearly three-fourths of those that depicted smoking were rated R, and instances of smoking in films not rated R have declined” though this is not enough for the anti-smoking groups.

So what is the difference between a PG-rated film and an R-rated film?  According to the MPAA, a PG-rated film requires

investigat[ion] by parents before they let their younger children attend.  The PG rating indicates… that parents may consider some material unsuitable for their children, and parents should make that decision.  The more mature themes in some PG-rated motion pictures may call for parental guidance.  There may be some profanity and some depictions of violence or brief nudity.  But these elements are not deemed so intense as to require that parents be strongly cautioned beyond the suggestion of parental guidance.  There is no drug use content in a PG-rated motion picture.

(Emphasis added.)  On the other hand, an R-rated film will

contain some adult material.  An R-rated motion picture may include adult themes, adult activity, hard language, intense or persistent violence, sexually-oriented nudity, drug abuse or other elements, so that parents are counseled to take this rating very seriously.  Children under 17 are not allowed to attend R-rated motion pictures unaccompanied by a parent or adult guardian. Parents are strongly urged to find out more about R-rated motion pictures in determining their suitability for their children.  Generally, it is not appropriate for parents to bring their young children with them to R-rated motion pictures.

(Emphasis added.)  Elizabeth Kaltman, a spokeswoman for the MPAA, told TheWrap that

underage smoking has always factored into movie ratings, but as of May 2007, all smoking is included as a ratings factor, along with language, nudity and other adult content. Kaltman adds that movies depicting smoking in a fantastical rather than realistic manner are more likely to receive slack on the ratings front.

As for Smoke Free Movies’ suggestion that smoking and the PG rating don’t mix? Kaltman notes that the purpose of the ratings system is to provide parents with information, not to service activists.

People younger than 18 years can’t buy cigarettes.  Tobacco companies should not target children and teenagers.  Should the same rules apply to tobacco use in films?  How much responsibility should be imposed on the MPAA (whose rating system has been called into question by This Film Is Not Yet Rated and others) and how much responsibility should rest with parents who can choose not to take their children to a film with smoking in it?  What about re-runs of television shows from the 1950s, 1960s and 1970s which show people smoking?  Should Popeye, Maxwell Smart, and Lieutenant Columbo lose their pipe, cigarette, and cigar?  As a kid, I saw re-runs of shows with these characters and I didn’t become a smoker.  Should such shows be banned from television all-together so children aren’t exposed to smoking or only aired after 9pm to limit the chance of exposure?  Where and when do we draw the line?

Time To Tighten That Belt….

Keep an eye out for the April edition of the American Journal of Medicine.  In it, the Los Angeles Times and U.S. News Health Blog report that you will find a new study from the Centers for Disease Control and Prevention (CDC) which identifies the “diabetes belt.”  Almost 26 million Americans – that’s 8% of the population – have type-2 diabetes, the most common form of diabetes (as opposed to type-1) often connected with weight and physical activity.  In a county-by-county census, the CDC  identifies 644 counties in 15 states where the type-2 diabetes rates are higher (11%) than the national average (8.5%).  Ethnicity, age, weight, and a sedentary lifestyle were found to be key factors.

The Los Angeles Times describes the “belt” as stretching “down the southeastern seaboard, ’round the silty Mississippi Delta and following the Appalachian Mountains north across Tennessee, Kentucky and West Virginia” and including parts of Pennsylvania (but stopping short of New Jersey).  Dr. Lawrence Phillips, who studies diabetes at Emory University, told Reuters that

[s]ince diabetes is one of what we call the silent killer diseases … it’s important for the public to be aware that this is a problem….  What this does is to give health care providers ammunition. A provider can say, ‘We’re in the diabetes belt. All of these things are increased in part because of the way we live, and all of these things can be improved to a certain extent. Our risks can be decreased … by eating healthier and to the extent that we can, being less sedentary.’”

The “diabetes belt” appears to overlap with the decades-old “stroke belt” and the recently identified “heart failure belt.” Be sure to check out whether your home state falls within one of these belts.  And then remember to tighten yours.

High School Just Says No to Medical Marijuana

Remember the “Just Say No” and D.A.R.E. anti-drug campaigns way back in the day?  I do.  That’s when the high school kids would come to my elementary school, put on a play, and divide us into small groups for a talk on how we shouldn’t use drugs.  I think there was even a song in there somewhere.  Remember those bizarre zero-tolerance policy stories too?  The ones about a middle school student who was suspended for touching and refusing a proffered Adderall pill or a little kid who was suspended for bringing a camping utensil to school and then required to attend an alternative school for 45 days?

So what should parents and teachers do when a high school student may legally take medical marijuana lozenges to treat diaphragmatic and axial myoclonus, a rare condition which causes him to suffer seizures that can last for 24 hours, but may not legally do so when the seizures occur at school?  As The Colorado Independent reports, that’s the question facing a Colorado Springs teenager who needs to take such lozenges for seizures that can happen without warning and a high school that doesn’t want him to have the lozenges on its property.

You see, 15 states – Alaska, Arizona, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Jersey, New Mexico, Oregon, Rhode Island, Vermont, and Washington — and the District of Columbia have legalized medical marijuana.  Nine states — Connecticut, Delaware, Idaho, Illinois, Maryland, Mississippi, New Hampshire, New York, and Oklahoma — have similar legislation pending.  In November 2000, 54% of Colorado voters approved the legalization of medical marijuana through Ballot Amendment 20.  The law went into effect on June 1, 2001.  (Nine years later, Governor Bill Ritter signed House Bill 1284 and Senate Bill 109 into law, providing a regulatory framework for dispensaries and addressing potential fraud and abuse.)

The Colorado Department of Public Health and Environment (CDPHE) maintains the Medical Marijuana Registry program which accepts and processes applications for Registry Identification cards.  The registration process is fairly straightforward.  Under 5 CCR 1006-2, an adult patient/applicant (over the age of 18) must submit a notarized application which includes name, address, date of birth, Social Security number, name and address of primary-care giver (if applicable), written documentation from the applicant’s physician confirming his or her debilitating medical condition, name and address of the applicant’s physician, and a copy of an identity document.  For a minor patient/applicant (under the age of 18), a parent residing in Colorado must submit written consent and the applicant’s name, address, date of birth, Social Security number, written documentation from two of the applicant’s physicians confirming his or her debilitating medical condition, the name and address of the two physicians, consent from the applicant’s parents residing in Colorado, and documentation from one of the physicians about the risks/benefits of the medical marijuana treatment.

In June 2010, CDPHE reported that 95,477 Coloradan patients possess valid Registry Identification cards… and only 24 of those patients — a mere 0.0251%  — are minors.  However, if you read the fine print in C.R.S.A. § 25-1.5-106(12)(B)(IV), you’ll note that “[a] patient or primary caregiver shall not: possess medical marijuana or otherwise engage in the use of medical marijuana in or on the grounds of a school or in a school bus.”  What should minors do if they’re still in school and need to take their medicine?

So maybe the Colorado Springs high school isn’t without reason for prohibiting this student from bringing his lozenges onto its property.  It’s an oversight on the part of the legislature to be sure and I wonder if any of the other 23 registered minors have experienced similar problems.  The obvious compromise would be to allow the student to go home and take his medicine as needed — The Colorado Independent reports that he switched schools last year to be closer to home for this very reason — and then return to school.  Yet until this past week the school told the student that this wasn’t an option.  Besides, it’s not a wholly satisfactory compromise if the student has to walk home while having a seizure.

Senate Votes Against Repeal: Out of the Woods but for How Long?

Last Wednesday, the Senate voted 47-51 against the “Repealing the Job-Killing Health Care Law Act.”  50  Democrats and one Independent voted against the Act while all 47 Republicans voted in favor of it (click here to view results).  No surprises there… but where do we go from here?

The Washington Post and the New York Times report that pro-repeal Senators and activists remain energetic and optimistic.  Senator John Cornyn (R-Texas) observes “[t]hese are the first steps in a long road that will culminate in 2012.”  Marilyn Shachter, a tea party activist, predicts a repeal “definitely will happen. It may take until 2012, or after 2012, when we get rid of Mr. Obama and a lot of these borderline senators that are up for reelection are replaced.”  Keith Hennessey, former Assistant to the President for Economic Policy and Director of the National Economic Council, outlines a two-year “path to repeal” the Patient Protection and Affordable Care Act (PPACA):

• Keep up the pressure in 2011 and 2012:
  • maintain and strengthen Republican unity toward full repeal;
  • repeatedly attack the bill legislatively on all fronts, knowing that most votes will pass the House and fail in the Senate;
  • continue legal pressure through the courts; and
  • tee up repeal as a key partisan difference in the 2012 Presidential and Congressional elections;
• In 2012 win the White House, hold the House majority, and pick up a net 3 Republican Senate seats to retake the majority there; and
• In 2013, use reconciliation to repeal ObamaCare, requiring only a simple majority in the Senate.

ABC News notes that the latest repeal attempt “was just one of three ways the Republicans are trying to kill the health care law.”  The second way involves the constitutional challenges filed in the courts.  The third way involves Senator Lindsey Graham (R-SC) and Senator John Barrasso’s (R-WY) proposed legislation allowing states to opt out of certain PPACA provisions, such as the individual mandate.

I would add a fourth way: good ol’ public relations (see my previous post on renaming/rebranding PPACA).  For instance, last Thursday Alaska Governor Sean Parnell announced that he had asked the state attorney general whether implementing and enforcing PPACA would violate his oath of office.  The Governor described himself as being “caught between a federal government that says, ‘You must pursue this, you must pursue this,’ and I have the duty to uphold the rule of law.”  There’s some solid, dramatic PR right there.

Be that as it may, the Senate has spoken.  The lower courts have spoken.  Senators Graham and Barrasso have spoken.  Governor Parnell has spoken.  Members of this blog have spoken.  Must we wait until Mr. Hennessey’s two year “path to repeal” has been successfully implemented or foiled before the Supreme Court chimes in?

A “Sputnik Moment”? Hopes for Renewed Drug Development With A Little Help From Our NIH Friends

In his State of the Union Address, President Obama tried to spark the “creativity and imagination” of the American people when he proclaimed

[t]his is our generation’s Sputnik moment.  Two years ago, I said that we needed to reach a level of research and development we haven’t seen since the height of the Space Race.  And in a few weeks, I will be sending a budget to Congress that helps us meet that goal.  We’ll invest in biomedical research, information technology, and especially clean energy technology… an investment that will strengthen our security, protect our planet, and create countless new jobs for our people.

Now I don’t know what came first — the chicken or the egg — but President Obama’s speech about investing in biomedical research and technological innovation follows National Institutes of Health (NIH) Director Francis Collins’ proposal to create a National Center for Advancing Translational Sciences (NCATS) to encourage drug discoveries and facilitate translational research in compounds overlooked by or abandoned by pharmaceutical manufacturers.  So does Dr. Collins’ proposal qualify as a “Sputnik moment”?

You might not have realized it, given those never-ending TV and magazine advertisements for prescription products (whose side effects sometimes sound worse than their benefits, but that’s another blog post), but pharmaceutical manufacturers have reduced their investment in researching and developing drugs.  According to the New York Times, pharmaceutical manufacturers spend over $1 billion developing a drug, with some “typically spend[ing] twice as much on marketing as on research” though that’s “a business model that is increasingly suspect.”  (For a brief overview of the research and development process, click here.)  The Pharmaceutical Research and Manufacturers of America (PhRMA) estimates that its members spent $45.8 billion in 2009 in research alone.

Even so, the number of drugs approved by the Food and Drug Administration (FDA) has dropped over the last 15 years and that’s not due to a lack of scientific information or higher FDA standards.  In November 2010, Forbes health blogger Matthew Herper reported on  the annual meeting of the American Society of Human Genetics at which Dr. Collins

implored his colleagues in genetics to work to develop new treatments for rare diseases. His point was that the NIH and the Food and Drug Administration are increasingly able to handle preclinical and early clinical drug development, and that with these first steps taken medicines are more likely to be brought to market by large pharmaceutical companies.

Mr. Herper also noted that a few organizations, such as the Cystic Fibrosis Foundation and the Multiple Myeloma Research Foundation, have taken a similar route in pushing along research  until a pharmaceutical manufacturer picks up the slack.  Then a month later, Arthur H. Rubenstein, dean of the University of Pennsylvania School of Medicine and chair of the NIH Translational Medicine and Therapeutics Working Group, told the Wall Street Journal Health Blog, “[b]asic science has exploded but it has not translated into benefit for the public.  The question was what to do about it.”

In stepped NIH to ease, in the words of the WSJ Health Blog, the “mounting frustration that a wealth of new information about the molecular basis of diseases hasn’t produced more new therapies.”  On December 7, 2010, NIH’s Scientific Management Review Board (SMRB) voted 12-1 in favor of adding NCATS to NIH.  Dr. Collins notified Health and Human Services Secretary Kathleen Sebelius of the decision.  Then on January 14, 2011, Secretary Sebelius sent a letter to Congress.  However, the decision to add NCATS  meant dismantling one of the 27 NIH centers and institutes, per the requirements of a 2006 law (“27″ is the “magic number”).  The lone SMRB dissenter, Jeremy Berg, director of the National Institute of General Medical Sciences, said he was “concerned that the implications for the rest of NIH hadn’t been adequately discussed.”

And therein lies some of the controversy.  NIH envisions NCATS as a link between basic discovery research and therapeutics care by:

• providing a visible, central locus for access to resources, tools, and expertise related to translational medicine;
• streamlining and improving the process of therapeutics development;
• serving as a catalyst, resource, and convener for collaborative interactions by supporting novel and innovative partnerships between multiple key stakeholders, including academia, government, industry, venture capitalists, and non-profit organizations;
• expanding the pre-competitive space by, among other things, enabling and providing incentives for greater sharing of scientific information and publication of negative results;
• supporting and strengthening translational medicine and therapeutics research, including providing access to services and resources for high-throughput screening, assay development, medicinal chemistry, and preclinical modeling;
• training translational research investigators; and
• enhancing communication among all stakeholders.

PhRMA Senior Vice President David E. Wheadon supports NCATS because

[c]ollaboration — including industry, NIH and academia — is one element driving innovation in drug development, particularly early stage — and ‘bold and ambitious’ proposals, such as Dr. Collins’, will be key to how we collectively progress in discovering novel compounds for addressing patients’ unmet medical needs….

The fact remains that biopharmaceutical research companies today and in the future will play a pivotal role: Our companies create the vast majority of new medicines from start to finish and, for the remainder, in close collaboration with academia and NIH, fulfill the critical final phase that transforms promising molecules into actual medicines for patients.

The WSJ Health Blog notes that NCATS isn’t NIH’s first foray into developing drugs.  In 2009, NIH created the Therapeutics for Rare and Neglected Diseases (TRND) program for basic research on rare diseases.  This early stage of drug development, WSJ Health Blog notes, is “expensive, time-consuming… prone to failure” and often not worth the effort for pharmaceutical manufacturers since the related market is small.

However, this time NIH must restructure several programs to accommodate NCATS, including the Molecular Libraries screening program, TRND, and the National Center for Research Resource’s (NCRR) Clinical and Translational Science Awards.  NCATS would house all three programs, along with the in-the-works Cures Acceleration Network (a drug-development program created by the Patient Protected and Affordable Care Act).

Staff members and researchers connected with the NIH community aren’t too thrilled over the restructuring, particularly with respect to NCRR.  If you visit Feedback NIH, the online forum for public commentary on NIH initiatives, you can read through the 1,100+ lengthy NCATS-related comments.  You’ll also see the “Separating Fact & Fiction” post by Dr. Francis Collins, which begins:

[b]y now, many of you have read the recent New York Times article or related news coverage, about NIH’s plan to establish the National Center for Advancing Translational Sciences (NCATS).

While we are pleased that the news media have recognized NIH’s efforts as a significant development for translational research, the Times article contains some misleading statements that we would like to clarify. Those statements suggest that a much larger shakeup of NIH is underway than is actually contemplated.

So, to set the record straight, we want to share with you what we know at this point in time…

(internal links removed).  The “we” includes Members of the Institute and Center Directors NCATS Working Group.  The post attempts to clear up concerns about budget cuts (House Republicans have already promised to cut the discretionary spending that supports NIH), the security of existing programs, and the misconception that NCATS will be a drug company.

Despite the negative responses, Dr. Collins remains optimistic.  In an interview with ScienceInsider, he emphasized that

the NIH director is called upon to look for scientific opportunities that aren’t being met and to figure out how to make them happen, and that sometimes requires moving things forward at a rapid pace, and that affects a lot of people.

And of course change is always distressing, especially if people aren’t quite sure where it’s going. So I understand the anxiety that currently exists.

But let’s wait a year and see when this has all taken shape how people feel at that point. Will they say at that point that projects or programs at NCRR got dealt a bad deal? I bet they won’t. Will they say they’re excited about the translational science opportunities that are taking shape in the form of this new center? I bet they will.

Perhaps if purse strings weren’t so tight and the healthcare reform debate was settled — or if NIH wasn’t limited to 27 centers and institutes — the creation of NCATS might not upset so many people.  Yet has Dr. Collins displayed a little of that “Sputnik moment” spirit by accelerating the development of drugs for diseases and other areas overlooked by pharmaceutical manufacturers?  Sure.  Just don’t expect him to take us to the moon.

What’s In A Name? Possibly the Future of American Healthcare

Recent news about House GOP efforts to push through a bill nicknamed the “Repealing the Job-Killing Health Care Law Act” that would scale back healthcare reform has reminded me of a passage from Shakespeare’s Romeo and Juliet:

“What’s Montague? it is nor hand, nor foot,
Nor arm, nor face, nor any other part
Belonging to a man. O, be some other name!
What’s in a name? that which we call a rose
By any other name would smell as sweet;
So Romeo would, were he not Romeo call’d.”

So Juliet Capulet reasons through her love for Romeo Montague, who comes from a rival family, and suggests the two set aside their family names and rivalries for the sake of their love.  Okay, so the situation here isn’t quite the same and I daren’t suggest that certain political characters set aside their rivalries for the sake of the American people’s health and well-being (although, heaven forbid, it might be in our best interest!).  Yet the discussion of names — in terms of how the people associated with them can bring us together or tear us apart, branding, and even media spin — seems appropriate for our current political and social climates.  Starting with the Protected Patient Affordable… wait, errr… Obamacare… no, wait, got it, the Patient Protection and Affordable Care Act, also known as the “Affordable Care Act.”

In “Why The Affordable Care Act Needs A Better Name: ‘Americare’” (Health Affairs, August 2010), William Sage, vice provost for health affairs at UT-Austin, makes the most sensible suggestion of rebranding the healthcare law so it “become[s] something that beneficiaries would not only accept, but would also defend.”  Professor Sage proffers “Americare” as a name that:

would assert a collective interest in health system value and efficiency. It would build courage to do more than tinker at the margins with new payment methods, organizational structures, and professional skills. Most important, a shared identity would signal our decision to rein in special interests and begin a social conversation about redesigning health care delivery to produce the most cost-effective results.

Promoting a new name that fosters a collective identity — and, furthermore, that is catchy and inspiring — is not only sensible, but obvious (consider the “No Child Left Behind Act” — the policy may have its critics, but the name sure is catchy and who would argue in favor of leaving a child behind?).  So obvious, in fact, that I don’t know how the healthcare reform proponents missed the boat (Professor Sage considers three reasons why), because their opponents not only caught the boat, but started steering it right at them:  “Obamacare” (which, even if you believe it’s a friendly term (and I don’t), still focuses on the individual – the President – rather than the collective health of the American people), ”death panels,” and the “Repealing the Job-Killing Health Care Law Act.”

The AP recently reported on some statistics forecasting healthcare-related job losses that are wildly circulating around our nation’s capital.  The nonpartisan Congressional Budget Office (CBO) projected that the current healthcare law “will reduce the amount of labor used in the economy by a small amount –roughly half a percent– primarily by reducing the amount of labor that workers choose to supply” because people won’t be trapped in a job just to get the health benefits.  A recent report by House GOP leaders has cited the CBO projections and has interpreted them to mean some 650,000 jobs could potentially be in jeopardy.

Yet far from cutting the number of available jobs, the current law enables people to voluntarily leave the workforce (by retiring earlier) or continue to work in less demanding jobs.  AP reporters found that:

the law’s penalties on employers who don’t provide health insurance might cause some companies to hire fewer low-wage workers, or to hire more part-timers instead of full-time employees…. But the main consequence would still be from more people choosing not to work.

So what has the CBO (actually) said about the “Repealing the Job-Killing Health Care Law Act” (before more numbers start wildly circulating)?  In a letter to Speaker of the House John Boehner, the CBO analyzed, among other things, the bill’s potential impact on federal budget, discretionary spending, and the number of insured.  With respect to the effects on the number of insured, the letter states that under the bill:

about 32 million fewer nonelderly people would have health insurance in 2019, leaving a total of about 54 million nonelderly people uninsured. The share of legal nonelderly residents with insurance coverage in 2019 would be about 83 percent, compared with a projected share of 94 percent under current law (and 83 percent currently).

That projected difference of 32 million in the number of uninsured people in 2019 reflects a number of differences relative to circumstances under current law. Approximately 24 million people who would otherwise purchase their own coverage through insurance exchanges would not do so, and Medicaid and the Children’s Health Insurance Program would have roughly 16 million fewer enrollees. Partly offsetting those reductions would be net increases, relative to the number projected under current law, of about 5 million people purchasing individual coverage directly from insurers and about 3 million people obtaining coverage through their employer.

Even if the Senate doesn’t approve the bill, CNN reports that healthcare law opponents, such as House Majority Leader Eric Cantor (R-VA), promise to, at the very least, defund and delay healthcare reform provisions.  Either way, healthcare law proponents must rethink their campaign to maintain (or rally, depending on how things go) support among the American people…  starting with an inspiring, new name.

(My thanks to my dad for emailing me the AP article that inspired this post and to Kate Greenwood for directing my attention to Professor Sage’s article).

New Year’s Resolution #1: Preventive Care and Negotiated Costs

Happy 2011, folks!  It’s a new year of reformed eating, exercising, spending, and no-smoking habits.  It’s a new Congress with promises or threats (depending on your view) of healthcare repeal.  And with the help of U.S. Preventive Medicine, Inc., it’s a new year for Sam’s Club shoppers to reach their health goals with the “The Prevention Plan.”  Or is it?

For $99 a year, Sam’s Club shoppers can access:

a personalized, step-by-step health management program designed to help people take control of their individual health.  Via an online health assessment and at-home blood test [measuring cholesterol, blood glucose, and Hemoglobin A1c levels]… members can take the first steps in identifying potential individual health issues.  From there, a personalized plan is created to address risks.  Personal health coaching, ongoing support, a variety of tools and a plan-wide health challenge are provided through The Prevention Plan to keep members motivated to maintain a healthy lifestyle.

Although the Plan includes a 24/7 nurse line, 20 online education programs, recommended prevention screenings, and a detailed member report, it isn’t a substitute for regular health insurance… or for a primary care physician.  In a CNNMoney report, U.S. Preventive Medicine CEO Christoper Fey suggested that shoppers “[t]hink of it as what a financial planner does.   He takes all the information you provide, assesses the risk and gives you a plan on how to improve your financial health.  The prevention plan does a similar thing, but for your health.”  In the same report, a director of health policy at Families USA, a consumer advocacy group, said that she “worr[ied] about people thinking of this prevention plan as a substitute for an annual checkup at a doctor’s office.”

Participating in preventive care and services makes a lot of (dollars and) sense.  Okay, a little lame joke.  Seriously, though, why sit around when you can take measures to try to maintain your health and to prevent certain diseases from occurring?  The Patient Protection and Affordable Care Act recognizes the benefit of preventive care and services — remember, there’s that provision concerning free access to important screenings, tests, vaccinations, and the like.

Yet I’m somewhat skeptical about the benefits of paying $99 to enroll in this Sam’s Club Plan.  For starters, it sounds like the same kind of educational information and health tips can be found on other sites such as WebMD… and at no cost to the consumer/patient.  Okay, well, maybe WebMD doesn’t come with a 24/7 nurse line.  Yet after you take the at-home blood test, upload the results, and figure out your health summary, you’ll still need to consult a doctor to figure out whether any additional screenings are required.  So take that $99 and add to it the cost of your co-pay… or whatever you might pay out-of-pocket if you don’t have insurance.

Speaking of which, be sure to check out a recent New York Times article which reminds us how (most of) everything in life is negotiable, including healthcare and prescription costs.  Similarly, a NPR blog post discusses how some drug manufacturers offer coupons or subsidy cards to reduce prescription costs–but as Kate Matos mentioned the other day here at HRW, that too comes with a cost.

Anti-Smoking Efforts Light Up

In an effort to discourage Americans from smoking, the Food and Drug Administration (FDA) recently unveiled a proposal requiring cigarette packages and advertisements to display large, color graphic warnings.  The proposal calls for nine warning statements accompanied by a color graphic depicting the health consequences of smoking, such as addiction, stroke and heart disease, cancer, open sores, harm to children via second-hand smoke, harm during pregnancy, and death.  (Click here and here to see the 36 proposed statements and color graphics.)  Members of the public can submit their comments to the FDA until January 11, 2011.  The FDA will make its selection in June 2011.  Come October 2012, the warnings will cover 50% of the front and back of a cigarette package, and 20% of the space of a cigarette advertisement.

So what brought about this change?  You may have missed the news last summer, but a new law called the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave the FDA the authority to regulate tobacco products and required these large, graphic modifications to cigarette packages and advertisements.  According to FDA Commissioner Margaret Hamburg, “every pack will become a mini-billboard that tells the truth about smoking.”  The American Academy of Physicians notes that

[t]he FDA has taken several steps since it was given authority to regulate the tobacco industry last year. The agency already has prohibited the use of the terms ‘light,” “low” and “mild” in cigarette marketing and packaging; banned cigarettes with fruit, candy, and spice flavors; and restricted the sale and marketing of tobacco products so that young people are less likely to be exposed to tobacco ads.

Approximately 20% of Americans smoke.  The government hopes to reduce that number to 12% by 2020.

In August 2009, R.J. Reynolds Tobacco Company (maker of Camel, Pall Mall, Doral, Kool, Winston, and Salem) and several other tobacco companies filed a lawsuit in the Western District of Kentucky to “protect their First Amendment right to communicate with adult tobacco consumers products.”  ¶51 of the complaint stated that

[b]ecause the Act virtually eliminates Plaintiffs’ ability to communicate to adult consumers through advertising, the only remaining vehicle for such communication is product packaging. But the Act destroys this as well, seizing a substantial portion of Plaintiffs’ packaging for a Government-drafted anti-tobacco message–including, for cigarette packaging and advertising, the use of shocking, graphic color imagery–as well as other mandated information….

The tobacco companies didn’t win on that point.  Obviously.

However, America won’t be the first country to employ “scare tactics” (and I use that phrase in a neutral way).  Canada, England, Brazil, Thailand, Turkey, and Australia are among the 39 countries to cover their cigarette packages with graphic warning labels that “tell it like it is” (that phrase was less neutral).  Last month, the Canadian Cancer Society released its “Cigarette Package Health Warnings: International Status Report” which summarized health warning requirements by country/jurisdiction and showed graphic labels from around the world.  (Ironically, the report comes across as a little competitive when it compares the size of the graphic labels.)

Yet supporters and critics alike question the effectiveness of this approach.

Take our neighbors to the north.  Although The Wall Street Journal reported that smoking rates dropped 3% among Canadians after their graphic warning labels appeared, the newspaper also noted how “other tobacco prevention measures, such as cigarette tax increases and new restrictions on public smoking, came at the same time.”  On NPR’s All Things Considered, David Sweanor, a law professor at the University of Ottawa, observed that

[w]hat we see with these sorts of warnings is that it does increase motivation…. People are more aware of the risks. They are wanting to quit. But that has to be combined with services that make it more likely.

Professor Sweanor went on to say that the desired outcome — fewer smokers – has been disappointing because the “[Canadian] government hasn’t provided enough access to smoking cessation programs.”

At home, The Wall Street Journal interviewed Jonathan Whiteson, medical director of NYU Langone Medical Center’s cardiac and pulmonary wellness and rehabilitation program, who suggested the labels should promote a “positive message” emphasizing the benefits of a smoke-free life, because

[w]hen we emphasize feeling good, the sense of mastery that comes from making a behavioral change or the promise of an enhanced chance of avoiding heart disease or cancer — that [produces] a much more positive and effective response from patients.

Mr. Whiteson added that smokers already are aware of the negative consequences of smoking, but just might be in denial about them.  He also noted how the public generally becomes desensitized to shocking images.

So could reverse psychology work better?  A relatively recent study published in the Journal of Experimental Psychology found that certain smokers who based their self-esteem on smoking were not deterred by death-related warnings.  Instead, the study found that

warning messages that were unrelated to death effectively reduced smoking attitudes the more recipients based their self-esteem on smoking. This finding can be explained by the fact that warnings such as ”Smoking brings you and the people around you severe damage” and ”Smoking makes you unattractive” may be particularly threatening to people who believe the opposite, namely that smoking allows them to feel valued by others or to boost their positive self-image. To the degree that warning messages undermine the high smoking-based self-esteem, smoking may be devalued.

I was interested to come across this study because Prescriptions, a NY Times blog, recently wrote about R.J. Reynolds’ special-edition packs of Camel linking the cigarettes with hip images of certain American cities, including the Williamsburg neighborhood in Brooklyn.  The Williamsburg package says

Some call it the most famous hipster neighborhood.  But it’s not about hip. It’s about breaking free. It’s about last call, a sloppy kiss goodbye and a solo saunter to a rock show in an abandoned building.  It’s where a tree grows.  It’s Camel in the Williamsburg corner of Brooklyn.

If self-esteem and smoking are connected for some people… well, I can see a spin-off warning statement and graphic there which might be an effective deterrence.  Can you?

Alongside the FDA graphic warnings proposal, the Department of Health and Human Services has announced other tobacco-related projects in the works, including:

• The Affordable Care Act is giving Americans in private and public health plans access to recommended preventive care, like tobacco use cessation, at no additional cost.
• The American Recovery and Reinvestment Act (ARRA) invested $225 million to support local, state and national efforts to promote comprehensive tobacco control and expand tobacco quitlines.
• The Prevent All Cigarette Trafficking Act (PACT) aims to stop the illegal sale of tobacco products over the Internet and through mail order, including the illegal sale to youth. [...]
• The Children’s Health Insurance Program Reauthorization Act (CHIPRA) raised the federal cigarette tax by 62 cents per pack.  Raising the price of tobacco products is a proven way to reduce tobacco use, especially among price-sensitive populations such as youth.

Just as an FYI, check out this NY Times article about ongoing efforts in other countries to restrict the the marketing of cigarettes.

The Boys Are Back In Town… But Will They Have Much Repeal?

A week before the election, the  L.A. Times quoted Senator Orrin Hatch (R-Utah) as saying his party “could come up with a healthcare system that American people would not only be proud of, but would actually love.”  That same article reported how Republican and other conservative candidates have been promising to repeal the Patient Protection and Affordable Care Act (PPACA) without proposing a viable alternative.  In fact, the Republican track record for the past decade isn’t anything to trumpet.  Rather than lowering healthcare costs and expanding access to care,

from President George W. Bush’s election in 2000 to the end of GOP congressional majorities in 2006, Republicans failed to pass major healthcare changes despite evidence of an escalating crisis.

American workers saw their health insurance premiums jump 78%, as the average price tag for an employer-provided family health plan surged to $11,480 a year, according to a survey of employer health benefits by the nonprofit Kaiser Family Foundation and the Health Research & Educational Trust.

That took a toll on businesses and employees. In 2000, 69% of employers provided their workers with health benefits, the Kaiser surveys found. In 2006, 61% were offering health insurance.

By the time Republicans lost control of Congress, an estimated 43.6 million Americans did not have health insurance, up from 41.3 million six years before.

Be that as it may.  The election has taken place, the Republicans have regained control of the House, and the country is left to wonder: are the days of PPACA — or any kind of healthcare reform — numbered?  The Washington Post observes that election day “[e]xit polls showed… roughly half the public wants to repeal the bill but that the other half wants to keep or expand it, setting the stage for a potential showdown.”  Prescriptions, a N.Y. Times health blog, interviewed a a portfolio manager and health care strategist, and found that he “‘[didn't] think anybody wants to kiss off 30 million new customers’….  What the health insurers and drug and device makers want is not repeal, he argued, but ‘reform light.’”

Granted, the Democrats still control the Senate, a Democratic president remains in office for at least two more years, and the Republicans didn’t win enough seats to override a presidential veto.  So if an outright repeal isn’t in the cards, then what other options do the Republicans have to scale back this “monstrosity,” to borrow the colorful phrase used by incoming House Speaker and Minority Leader John Boehner (R-Ohio)?

The N.Y. Times suggests that Republicans might direct Congress to chip away at or eliminate the less popular PPACA provisions, such as the tax on manufacturers of medical devices, the requirement for many employers to contribute to insurance for employees, or the mandate that everyone have health insurance.  The article notes that

with Republicans winning control of many governors’ mansions and making gains at the state legislative level, they will be able to determine how the new law is carried out locally.

Republicans in Congress said they would try to give states more latitude and discretion on issues like the design of health insurance exchanges. The law calls for creation of an exchange in each state and says only government-approved insurance plans can be sold on the exchange.

The new rules, though stricter than in the past, may well be less stringent than they would have been if Democrats had not taken what Mr. Obama described as “a shellacking.” In addition, Republicans said they would try to cut the budget for federal enforcement of the law and related rules.

On Wednesday, Rep. Boehner expressed his belief that “the health care bill will kill jobs in America, ruin the best health care system in the world and bankrupt our country.”  In response to these claims, Kaiser Health News asked 3 dozen people across the country,  including physicians, CEOs and Presidents, administrators: ”[i]f you ended up in an elevator with Rep. Boehner, what single thing would you urge him to do about health care in this country?”  (Click here to read their responses.)  I’d urge him to repeal his stance.

Develop Your Lawyering Skills Now and Your Health Law Job Will Follow

On Friday I attended the Fourth Annual Student Health Law Conference: Taking the Health Law Career Path co-sponsored by Seton Hall Law School and the American Society of Law, Medicine & Ethics (ASLME).  Originally I planned to attend only the morning session — both for my own benefit as a possible health law practitioner and because I’m a research assistant at the law school’s Center for Health & Pharmaceutical Law & Policy — but I found the panelists to be so engaging that I stuck around for the afternoon session and the networking reception.

Despite some recent good news concerning the job prospects for law students, especially for those in New Jersey, recent graduates and third or fourth year law students don’t need a Magic 8-Ball to tell them that compared to the hiring fests of 2005 and 2006,  the present “outlook [is] not so good.”  So what about health law jobs?  There are regular reports on how the healthcare industry has weathered the economic storm better than others (see Michael Ricciardelli’s blog posts on the continued growth of the healthcare industry here and here).  Peter Leibold, Executive Vice President & Chief Executive Officer of the American Health Lawyers Association, delivered a great keynote speech at the Conference emphasizing, among other things, how the field of health law is growing and, in particular, which areas of health law are flourishing.

Still, in the current clime finding a job as a health law practitioner fresh out of law school can seem like a rather daunting challenge.  But should it be?  Not so, said the panelists.

I attended five panels (out of 18) addressing the career opportunities available for those interested in “When a Medical License is at Stake,” “Health Information & Technology Practice,” “In-House Counsel: Pharmaceutical Companies,” “Government Enforcement of Health Care Fraud, and “Hospitals & Medical Groups: Compliance & Risk Management.”  The panelists represented a variety of employers, including the New Jersey Office of the Attorney General, the New York State Office of the Medicaid Inspector General, the United States Attorney’s Office for the District of New Jersey, Bristol-Myers Squibb, sanofi-aventis, Saint Peter’s University Hospital, and Saint Barnabas Health Care System.  Three panelists had worked for boutique or large firms but eventually branched out on their own.

Many of the panelists relayed a mixture of humor and frankness in their discussions about the current job market and their own past experiences in job searching.  Several noted that their current job came from prior work experiences that had built upon one-another.  Others outlined networking strategies and urged students to apply for internships.  However, one piece of advice could be heard over and over again: develop your lawyering skills now and your health law job will follow.

Maybe you want to work for a law firm specializing in health law. Maybe you want to be in-house counsel for a pharmaceutical company.  Or maybe you want to work for the government.  Regardless of which career path appeals to you, a recent law school graduate may hit a wall with potential employers looking for experienced candidates.  Both in-house counsel panelists acknowledged that pharmaceutical companies tend to prefer people with a few years of work experience. So if it’s in-house pharma you really want, you’ll just have to work your way there.

So while you search for a health law job, focus on developing a solid set of skills by taking that first job — even if it isn’t in health law — and learning how to be an effective lawyer.  That way you will have a marketable set of skills at the ready when a health law job does come your way. Always working towards the goal.

If you’re a recent graduate but you haven’t found a job, it’s suggested that you try the small firms, solo or dual practitioner offices– where you’re as likely as not to have complex files and entire cases dropped in your lap– amounting to invaluable and marketable experience. Barring that, look for freelance work or volunteer your legal services with an organization.  It’s better for you to have some legal experience on your resume than none at all.  For example, the Division of Law within the New Jersey Office of the Attorney General has a Volunteer Associate Program which enables recent graduates, deferred associates, and similarly-situated attorneys to hone their skills.  Participants must commit to 20 hours per week for 3 months.  Search around the internet or contact your career services office to find other organizations and government agencies offering similar programs.

Below are some other tidbits of information I gathered from the Conference.

Make yourself an expert and then use social media to market yourself. It is never too early to start making yourself an expert in a particular area of health law.  As a health law student or as a recent graduate, you can write articles on topics covered in class and then get your name “out there” by submitting those articles to blogs and other health law news sources.  If your articles are published, make sure to maintain a portfolio that you can present to prospective employers and update your resume accordingly.  If your articles are published online, you also can create a Twitter account and then make links to those articles. If you doubt the value in that, look up in the right hand corner of this blog and see in “Places Cited” where articles from Health Reform Watch have been cited– everything from the Health Care Blog to the New York Times and Washington Post and Maggie Mahar’s Health Beat. In addition, Seton Hall Law student Jordan Cohen presently holds one of the top rated google searches in America for “Accountable Care Organization.” Not a bad accolade or writing sample to bring a prospective employer.

Intern while you’re in school. Internships are key in this economy.  Internships help you develop lawyering skills, add work experience to your resume, provide work references, and give you additional contacts for your job search.  Note: if you are interested in working for the government, focus on internships with state and local agencies as well as federal agencies.

Remember your cover letter. To get your foot in the door for an interview, pay attention to your cover letter as well as your resume.  This is especially so if your background does not exactly match the position to which you’re applying (e.g., person with public interest background applies for a hospital compliance officer position).  Your cover letter presents the best opportunity to answer any questions that might arise in a prospective interviewer’s mind.  Be sure to check for typos.

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