HHS Grants $727 Million To Community Health Centers

The Patient Protection and Affordable Care Act (PPACA) continues to make headlines.  Recently the Department of Health and Human Services (HHS) awarded $727 million for construction and renovation projects at 143 community health centers across the country.  HHS Secretary Kathleen Sebelius noted that

[t]here is no question that the economic downturn has made it harder for some Americans to get health care and important preventive services.  Community Health Centers provide quality healthcare services to Americans across the country but are a life line for those who have lost coverage or are between jobs.  These funds from the Affordable Care Act will help get more people care in some communities where there have not been many options in the past.  The newly constructed or expanded community health centers will provide care to an additional 745,000 patients and much needed employment opportunities in both rural and urban underserved communities.

According to the National Association of Community Health Centers, there are approximately 1,200 centers across the country.  They provide care for 20 million patients.  Seventy-one per cent of these patients have family incomes at or below the poverty line while 38% are uninsured and 36% are on Medicaid.

Over the next five years, PPACA will provide $11 billion in grants to fund the construction, operation, and expansion of community health centers.  These grants come at the right time as Mary K. Wakefield, Administrator of HHS’ Health Resources and Services Administration, observes how

[m]any of these community health centers need more modern space to meet the increasing patient demand for services. These funds will help community health centers build new facilities and modernize their current sites in their continuing effort to provide the best care possible to more and more people in need.

The PPACA funding is in addition to the $2 billion allotted for health centers under the American Recovery and Reinvestment Act of 2009 (ARRA).  ARRA provided health centers with $500 million to expand services to new patients and $1.5 billion to support facility construction and renovation as well as equipment acquisition.  (Click here to see a list of grantees receiving ARRA funding.)

The Hum of Healthcare Reform

Shhhh.  Can you hear it?  Among all of that partisan pre-midterm election cheering and jeering? There’s a faint hum.  The cogs of healthcare reform have started to turn.

Thursday marked the six-month anniversary of the Patient Protection and Affordable Care Act (PPACA) and the implementation of several consumer protection provisions.  Can you believe it?  We now live in a society where:

• Children under 19 years old can no longer be excluded because of pre-existing health conditions;
• “Young adults” (19-25 years old “dependents”) can stay on their parent’s plan until they turn 26 years old;
• Insurers can no longer impose lifetime limits on benefits;
• Insurers can no longer deny payment for services once a consumer gets sick nor search for errors on a consumer’s application in order to deny payment for services once that consumers gets sick (a practice called “rescission”);
• Depending on your age, all new plans must provide certain preventive health services — such as colonoscopies, mammograms, routine vaccinations, and diabetes tests — without co-payments or deductibles;
• Annual limits on insurance coverage will be restricted; and
• Consumers are ensured the right to appeal coverage determinations.  If the insurer upholds its own decision, consumers can  appeal to an external review process.

Granted, these protections aren’t perfect.  For instance, “grandfathered” group plans do not have to offer coverage to young adults who qualify for group coverage at work nor do they have to offer the free preventive health services.  Mary Agnes Carey of the Kaiser Health Network points out that most consumers won’t benefit from these protections anyway until their new health year plan begins after January 1, 2011.  (Carey provides a basic Q&A on the provisions here.)

The greatest challenge for PPACA right now, though, seems to be the misperceptions circulating around the country.  A recent AP poll found that:

[m]ore than half of Americans mistakenly believe the overhaul will raise taxes for most people this year….

Many who wanted the health care system to be overhauled don’t realize that some provisions they cared about actually did make it in. And about a quarter of supporters don’t understand that something hardly anyone wanted didn’t make it: They mistakenly say the law will set up panels of bureaucrats to make decisions about people’s care — what critics labeled “death panels.”

The uncertainty and confusion amount to a dismal verdict for the Obama administration’s campaign to win over public opinion….

Yet, folks, PPACA provides long overdue protections that will have a tremendous positive effect.  The White House predicts that around 72,000 uninsured children with pre-existing conditions will gain coverage.  Getting Covered, a campaign dedicated to helping parents and young adults benefit from the healthcare reform, estimates that New Jersey has 209,000 uninsured young adults, but next year that number will have been reduced by almost 28,000.

These protections come in the nick of time, too.  Sabriya Rice of CNN reports that the impact of the bad economy has taken its toll on healthcare as:

[a] recent population report from the U.S. Census Bureau says there has been a dramatic increase in the number of people without health insurance in the United States. Between 2008 and 2009, the number of uninsured people increased by 16.7 percent, to nearly 51 million. An estimated 6.5 million people were no longer covered by private health insurance and equally as many had lost employment-based health benefits.

Patient advocates say Thursday’s changes are only the beginning. “The big resolutions will come in 2014 when you will start to see tens of millions of people getting coverage,” says Avram Goldstein, communication director for the Health Care for America Now, a liberal grass roots health advocacy organization.

Rice highlights a young man named Joshua Armstrong who took a break from school, lost his mom’s health insurance coverage and became one of the approximately 118,000 uninsured young adults in Alabama, and ran up a $10,000 emergency room bill after a car accident.  According to Getting Covered:

Alabama is actually one of ten states that have not required employers to expand dependent coverage at all. As a result, most family plans in Alabama currently only offer coverage to young adults up to age 19 or after college graduation. With the new law, young adults in Alabama will now be able to join their parent’s plan for longer even if they are financially independent, out of school, married, or live far away.

The new protection provision won’t help Armstrong with that emergency room bill — he’s worked out a repayment plan with the hospital — but it will help him secure insurance for the future.

AP reporter Carla Johnson similarly highlights three families affected by the PPACA protections: one whose son is uninsurable because he’s a cancer survivor, one whose son lost coverage when he maxed out the $1 million lifetime limit, and a man whose insurer retroactively canceled his coverage after he had a stroke.  The father of the latter summed up the situation quite nicely: “It’s despicable to leave a man who’s recovering from a stroke with no insurance.”  Yes.  Yes it is.  Keep on humming, PPACA.

Fourth Annual Student Health Law Conference To Be Held at Seton Hall Law on October 22nd

The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law will co-sponsor the Fourth Annual Student Health Law Conference: Taking the Health Law Career Path on Friday, October 22, 2010, in Newark, New Jersey.

This conference, which is attended by law students from law schools throughout the country, seeks to expose law students to the myriad career paths for attorneys in health and life sciences. The conference provides an introductory session on health law, panels on a variety of employment opportunities in health law, and a networking reception with the conference speakers. Career paths that will be represented include academia, compliance, private firms, government agencies, nonprofit organizations, drug and device companies, health insurers, and hospitals. Speakers for this year’s conference have been chosen for their health law expertise and background.

The format of the conference is a series of panels focused around a particular kind of health law career. Each panel is approximately one hour long and comprised of two to four panelists. Students will have the opportunity to explore nontraditional employment opportunities across the health law spectrum, receive support and guidance from professionals familiar with the experience needed for various careers as well as recruitment and hiring processes, and network with health law attorneys.

Interested in learning more about career paths for attorneys in health and  life sciences?  Click here for information on attending the conference.

Renewed Efforts to Reduce Industry Funding of CMEs

Last week’s Journal of the American Medical Association (JAMA) reported on the challenges that certain medical schools and medical centers across the country are facing as they decrease or eliminate industry funding of their continuing medical education (CME) programs.  These institutions have shown concern over the potential conflicts of interest when pharmaceutical and medical device companies fund educational programs which could bias future prescribers/customers toward their targeted products.  The adoption of industry-free CMEs could help filter out any potential marketing messages, and leave behind a balanced and evidence-based perspective.  After all, as the New York Times has reported, there are over 700 accredited CME providers in the United States and CME spending hovers around $2.5 billion per year, nearly half of which is paid by pharmaceutical and medical device companies.

Last year, three medical schools declined industry support for their CMEs: the University of Missouri-Kansas City School of Medicine, Nova Southeastern University College of Osteopathic Medicine, and Touro University Nevada College of Osteopathic Medicine.  This past June, the University of Michigan Medical School (UMMS) announced an actual policy change, effective January 1, 2011, whereby the school will no longer accept industry funds, which presently comprise almost 45% of its total CME funding.  UMMS believes contributions from various departments will help offset this sizable loss, as will higher CME registration fees and “less glamorous venues.”  UMMS is the first medical school to introduce such a policy and does so noting “we should take pride in our position as a national leader on this issue.”

This is all well and good, but in light of the enormous industry contributions, the $64,000 question really becomes: “Is Industry-free CME a Sustainable Model?“  And that’s exactly what speakers and attendees asked at the June 25, 2010, PharmedOut Conference entitled “Prescription for Conflict: Should Industry Fund Continuing Medical Education.” The conference was held at Georgetown University (PharmedOut is a Georgetown University Medical Center project funded by the Attorney General Consumer and Prescriber Education grant program.  Its team of physicians and academics lecture on the physician-pharma relationship, and provide access to online and industry-free CMEs).  Dr. Robert Wittes, Physician-in-Chief at Sloan-Kettering’s Memorial Hospital for Cancer and Allied Disease (”Memorial Hospital”), told his colleagues during the Conference that:

[t]here is life in CME after you do something like this.  But you have to be willing to prioritize the activity, such as putting institutional funds toward the balance [previously covered by commercial funds] and/or charge registration fees for CME activities that involve outside physicians.

Memorial Hospital stopped accepting industry money for its CMEs in 2007.  Dr. Wittes acknowledged that “[w]e don’t have these things in hotels in mid-Manhattan anymore; we have them on our own premises.”  Yet he cautioned against any institution from completely severing ties with the industry because there are positive interactions which can result in improved products and commercial science.

For further reading, check out Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy’s whitepaper on “Drug and Device Promotion: Charting a Course for Policy Reform.”  The Center makes several recommendations for overhauling the CME funding mechanism.  It also points out that accountants, lawyers, and other professions pay for their continuing education programs.   Be sure to check out Michael Ricciardelli’s post on industry funding of CMEs for nurse practitioners and Kate Greenwood’s post on ACCME Standards for Commercial Support too.

We May Need More Than A Spoonful Of Sugar To Help Our Medicine Go Down

Today CNNMoney reports that drug recalls quadrupled from 426 in 2008 to a record 1,742 in 2009.  The recalls have been attributed to “manufacturing lapses” in raw material quality, labeling and packaging, and contamination.  Generic and over-the-counter drugs have been affected the most.  CNNMoney notes that the race to put generic products on the market and the pressure to cut costs have caused drug companies to

sometimes fail to spend enough time learning how best to make the drug….  And since generic and over the counter drugs aren’t as lucrative for drugmakers as prescription drugs, companies may not be investing enough resources to make high-quality, safe products.

One such cost-cutting measure involves outsourcing production to foreign manufacturing sites and this measure seems to have received the most attention.  (Check out fellow blogger Jae W. Joo’s post on outsourcing.)

Earlier this month, Senator Michael Bennet (D-Colorado) introduced the Drug and Safety Accountability Act of 2010 which seeks to ensure the safety and efficacy of drugs sold in America, regardless of their manufacturing location.  The bill would require, among other things, that:

• manufacturers have quality management plans which the FDA can inspect;
• manufacturers maintain supply chain documentation;
• the Secretary of Health and Human Services track facilities manufacturing drugs or active ingredients for the American market; and
• the FDA be given more power to ensure drug safety, including the authority to enact mandatory recalls for batches of drugs that pose risks and to assess civil penalties for violations of the Federal Food, Drug, and Cosmetic Act.

Click here for more details about the bill and here for Sen. Bennet’s own promotion of it.  Sen. Bennet has lamented how:

[f]or too long, the FDA has lacked the proper authority to adequately safeguard our drug supply.  Americans need to be able to trust that the drugs in their medicine cabinets are safe, no matter where they’re made.

A father of three, Sen. Bennet has said that the recent McNeil recall of over-the-counter children’s medicine spurred him into action.

Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson has issued a statement in response to the bill, saying that:

[t]he lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop.  Brand-name pharmaceutical companies make tremendous investments in quality control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply.

In addition, drug manufacturing for the U.S. market — regardless of where it occurs — is regulated under Good Manufacturing Practices (GMP) by the Food and Drug Administration (FDA).  These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the U.S. prescription drug supply.

The U.S. regulatory system for prescription drugs is the toughest and safest in the world….

Okay.  But other people here don’t think so.  (Click here to read a good opinion by Dr. Lynn Parry, Chair of the Colorado Prescription Project, on why this bill should pass.)

According to a recent Pew Prescription Project poll, less than 10% of Americans feel confident about medications manufactured in India and China.  89% of Americans support Congressional action to introduce new drug safety measures.  How many of those people realize that approximately 80% of the materials used to make or package drugs sold in America comes from foreign sources?  I didn’t, but then, is such high a percentage really that surprising?

Reading through the CNNMoney report, I was reminded a little of a scene from a seventh season episode of Friends:

Phoebe: It’s amazing! My headache is completely gone! What are those pills called?
Monica: Hexadrin.
Phoebe: Oh, I love you, Hexadrin!  Oh look!  It comes with a story!
Monica: No, Phoebe, those are, like, the side effects and stuff.
Phoebe: Say what?
Monica: You know, the possible side effects.
Phoebe: Oh my God!  Dizziness, nervousness, drowsiness, facial swelling, nausea, headache…  Headache! Vomiting, stomach bleeding, liver damage!  Now, okay, I don’t recall any of this coming up when you gave me these little death capsules! Oh, I’m sorry, extra-strength death capsules!

Admittedly, the scene concerns how potential side effects can be worse than the problem being treated (and that’s a whole other blog post).  Yet it’s also a reminder of how we can forget about the other potential hazards of these potent drugs, delivered in easy-to-swallow capsules/tablets/liquids, if there are quality control or other manufacturing issues.  It’s as easy to forget as it is to pop them, well, like candy.

Developments In Domestic and Global HIV/AIDS Strategies

The White House recently released its HIV/AIDS strategy to reduce the number of new infections in the United States by 25% over the next five years.  During a press conference, President Obama observed that “[t]he question is not whether we know what to do, but whether we will do it.  Whether we will fulfill those obligations… to prevent a tragedy.”  Those obligations primarily concern reducing the number of new infections through HIV prevention programs, increasing access to and quality of care for those living with HIV, and decreasing HIV-related health disparities.  Right now there are 56,000 new infections in the United States every year.  Approximately 1.1 million Americans are living with HIV, but 1 in 5 don’t know it.

Advocates have criticized both the administration and Congress for failing to adequately fund HIV/AIDS efforts at home and abroad.  A recent AIDS Healthcare Foundation (AHF) “Who’s Better on AIDS?” advocacy advertisement unfavorably compared President Obama’s track record to that of President Bush.  (In 2003, the Bush administration implemented the President’s Emergency Plan for AIDS Relief (PEPFAR), a multibillion dollar initiative which has proved successful in lowering the AIDS death rate in Africa, though not the rate of HIV infection).   Michael Weinstein, President of AHF, told CNN that:

“when you see what this administration has done on AIDS, you have to give them very low grades.”

Obama has “consistently underfunded AIDS” programs, Weinstein said.  The president “did not mention the word AIDS for the first five months of his administration.  This national AIDS strategy has been worked on for 15 months, [and] I think it could have been done in 15 minutes.  There’s nothing new in it.”

Weinstein [also] criticized the administration’s intention to redirect money to those groups at greatest risk of contracting HIV/AIDS.  “It’s not good to pit one group against another and it’s unnecessary,” he said.  “The bottom line is that we should be seeking to get all sexually active people to get an HIV test.”

Some recent Canadian research also suggests another bottom line: treating people with HIV reduces the number of new infections.  And there the treatment is free.

The Center for Disease Control (CDC) recently presented its findings that heterosexuals living below the poverty line ($10,000 or less) in American cities were twice as likely to be infected with HIV as their higher-income neighbors.  The statistics translate to 1 in 42 people (the national average is 1 in 222 people).  Most studies focus on sexual orientation, race, and/or intravenous drug use.  None of those factors were included here though.  Kevin Fenton, a CDC HIV/AIDS expert, said that “HIV clearly strikes the economically disadvantaged in a devastating way.”  Researchers found that the risk of spreading HIV came from a lack of access to medical care and unawareness of infection.  Dr. Carlos del Rio, Chair of Global Health at Emory University’s Rollins School of Public Health, frames the issue differently as “[y]ou can talk about ‘Can we decrease the HIV burden in the United States?’  I would say, ‘What can we do to decrease poverty in the United States?’”

The 18th International AIDS Conference took place last week in Vienna, Austria.  Policymakers, researchers, advocates, and persons living with HIV met to draw attention to the epidemic and assess the global response to it.  According to the Associated Press, Julio Montaner, President of the International AIDS Society and Chairman of the Conference, opened the event by pointing to how:

the G-8 group of rich nations has failed to deliver on a commitment to guarantee so-called universal access and warned this could have dire consequences.

“This is a very serious deficit,” Montaner said.  “Let’s rejoice in the fact that today we have treatments that work … what we need is the political will to go the extra mile to deliver universal access.”

With the global economic crisis in full swing, AIDS activists are concerned about developed countries reducing their foreign aid, including funding for AIDS assistance.

In its annual report released last week, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the Kaiser Family Foundation found that global AIDS spending has “flattened.”  Although public and private sources contributed $15.9 billion in 2009, the amount was $7.7 billion short of the estimated $23.6 billion needed to combat AIDS in low and middle-income countries.  Contributing governments included the U.S. (58%), United Kingdom (10.2%), Germany (5.2%), the Netherlands (5%), France (4.4%), and Denmark (2.5%).  The report noted that “without U.S. funding, international AIDS assistance from donor governments would have significantly declined between 2008 and 2009.”

Possible Repeal of Massachusetts Ban: A Gift to Prescribers, Patients or Industry?

Next month marks the second anniversary of the enactment of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, a law requiring pharmaceutical and medical device manufacturing companies to designate a compliance officer and implement a compliance program reflecting the commonwealth’s regulations on meals, CME sponsorship, use of non-patient identified prescriber data, gifts and other payments, etc.  The law, which went into effect on July 1, 2009, builds upon the Pharmaceutical Research and Manufacturers of America’s revised Code  on Interactions with Healthcare Professionals (”PhRMA Code“) and the Advanced Medical Technology Association’s revised Code of Ethics on Interactions with Healthcare Professionals (”AdvaMed Code“), two voluntary codes intended to eliminate any influence — perceived or otherwise — of the industry over healthcare professionals with respect to gifts, entertainment, recreation, educational programs, professional meetings, scholarships, and the like.

The Massachusetts law is more restrictive, however, than its PhRMA and AdvaMed counterparts.  It prohibits companies from sponsoring continuing medical education programs that do not meet Accreditation Council for Continuing Medical Education guidelines.  The PhRMA and AdvaMed Codes do not.  It prohibits any company employee from providing meals outside of a hospital or office setting.  The PhRMA Code only restricts sales representatives and their immediate supervisors to a hospital or office setting.  The AdvaMed Code does not impose any restrictions on the location of meals.

Furthermore, starting on July 1, 2010, the law requires companies to annually certify their compliance with commonwealth regulations and, among other things, to disclose any gifts or payments valued over $50 and given to anyone who can prescribe, purchase, or dispense drugs or devices.  Effectively, it’s a ban on all gifts to prescribers (and in so doing goes a step further than the PhRMA and AdvaMed Codes which make an exception for educational gifts).  Companies must also submit $2,000, payable to the commonwealth’s Department of Public Health, with each annual disclosure report.  Violations can result in penalties up to $5,000 per occurrence.  The first round of disclosures were due 16 days ago and covered activities for the July 1, 2009 to December 31, 2009 period.  Next year companies will be expected to report on their activities for the January 1, 2010 to December 31, 2010 period.  Or will they?

The Massachusetts House recently passed an economic development bill that repeals the disclosure requirement/gift ban (the bill also establishes a sales tax holiday and consolidates commonwealth economic agencies).  The Senate version of the bill does not include the repeal.  It’s a wait-and-see as to how the two chambers will work out the final bill through their conference committee.

Opponents of the gift ban claim it has adversely affected pharmaceutical clinical research as well as the restaurant and convention industries.  Almost two years ago, PhRMA Senior Vice President Ken Johnson expressed his disappointment over the law, saying:

[it is] very likely damaging for medical partnerships, clinical research and patients in Massachusetts….

Public disclosure of a pharmaceutical company’s arrangements with principal investigators of its clinical trials also could reveal sensitive, proprietary business information to a company’s competitors.  This could erode the independent decision-making of companies trying to bring science from research facilities to patient care setting….

The disclosure requirements subjects all of the physicians, academic institutions and hospitals involved in such trials to publicity in a form that may be difficult to understand and likely will generate unwanted and unnecessary public scrutiny.  This could make Massachusetts an unattractive place for academic scientists to live and work — and for pharmaceutical research companies to do business.  Such a policy clearly is not in the best interest of public health — and it flies in the face of the ongoing efforts to further cultivate the life sciences industry within Massachusetts.

Indeed, the Wall Street Journal and Boston Herald report that some medical groups either have threatened to take their annual meetings elsewhere or have actually done so in protest of the law.

Supporters of the law say otherwise.  Health Care For All, a Massachusetts-based advocacy organization, views banning gifts as a step in the right direction.  According to the organization:

[t]he pharmaceutical industry gives gifts to promote their drugs and make a higher profit.  Under the guise of promoting welfare for all, the industry maximizes their own revenue….

Experts living within the guidelines of the gift ban find that it is not interfering with their work or professional relationships according to Dr. David Coleman, Boston University School of Medicine.

‘The Massachusetts Gift Ban legislation is an important step in the process of reducing both biases in therapeutic decision-making and healthcare costs.  The Ban has not adversely impacted the important relationships of our physician-faculty with the pharmaceutical and device industries….’

Health Care For All also maintains there is no connection between the decrease in restaurant revenues and the law as:

[t]he Massachusetts Prescription Reform Coalition has researched the decrease in restaurant profits, and found sales are down across the country — including in states without a gift ban.   According to the trade paper, Restaurants & Institutions, sales at the nation’s top 100 independent restaurants were down 10% in 2009….

Massachusetts Senators, who recognize the value of the gift ban legislation, also see that these lost profits mirror similar recession-caused losses in the restaurant industry across the country.

Georgia Maheras, Private Market Policy Manager at the Massachusetts Prescription Reform Coalition, considers the current House bill to be a “significant step backward” in the fight to curb medical costs.

Massachusetts is not alone in attempting to reform pharmaceutical and medical device marketing practices.  Neighboring Vermont has a similar, and in fact more stringent, law which even allows the Attorney General’s office to track free samples given to physicians (though a reporter for the Times Argus, a Vermont newspaper, worries how a repeal in Massachusetts might have a ripple effect).  California, the District of Columbia, Maine, Minnesota, Nevada, and West Virginia also have some form of a marketing code.  The federal government’s Patient Protection & Affordable Care Act includes the Physician Payment Sunshine Provision (”Provision”) requiring disclosure of payments made to physicians and teaching hospitals by manufacturers of products covered under Medicaid, Medicare, and SCHIP (click here to read a summary).

So who has it right?  It would seem as though PhRMA and AdvaMed opened the door for state and federal government to codify modified versions of these industry codes.  From a compliance perspective, it must be quite inefficient — and headache inducing — to wade through state marketing disclosure laws that lack uniformity.  Starting January 1, 2012, the Provision will preempt state disclosure laws except for where the state requires additional information.  Maybe this will help, maybe it will add to the headache, or maybe this particular episode will no longer matter.   For now, though, from a patient perspective, a repeal of the Massachusetts disclosure requirement/gift ban, or that of any other state, would feel more like a gift to the industry and prescribers than a service to the “best interest of public health.”

The Center for Health & Pharmacy Law & Policy here at Seton Hall Law has issued two white papers addressing these issues: Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” in which the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research; and Drug and Device Promotion: Charting a Course for Policy Reform,” in which the Center proposes legal and policy changes to address conflicts of interest in the relationship of medicine and industry– including the recommendation “that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians.”

The Center has also recommended “the adoption of federal legislation to ban the use of gifts, meals, and other perks to promote drugs and devices. The states have taken the lead to date–Massachusetts, California, Minnesota, and the District of Columbia have passed laws to limit or ban gifts and meals that are now routine in marketing practices. Concluding that industry self-regulation is not sufficient, the Center calls for national legislation to create uniform practices by industry and physicians. As urged by Professor Boozang, ‘the benefits of drugs and devices should drive promotion and physicians’ decision to prescribe, not a marketing model that depends on gifts and meals.’”

Obviously, the adoption of additional federal standards in this regard will lessen the ability of industry to pit one state against another and make compliance easier. The Physician Payment Sunshine Provision is a step in that direction, the Massachusetts development bill is a step back.

BP Isn’t Alone — Other Risks Lurk Beneath the Gulf Waters

Photo by kenhodge13 via Flickr

This isn’t Health Reform per se, but it’s hard to believe that that much oil in an eco-system (never mind the dispersants released which “had “no toxicity studies” done to support their use“) isn’t going to adversely impact public health long and short term. Time Magazine:

The question is what shape the impact of that catastrophe will take — mentally, physically, emotionally — on the people of the Gulf, now and for generations to come. Much is unknown about the long-term health dangers of an oil spill; few spills have been studied in this way.

A group of doctors and scientists who gathered in New Orleans on June 22 and 23 for a conference on the issue, hastily put together by the Institute of Medicine, came to the inevitable conclusion that a massive, multilateral effort must be launched now to track the health effects of the spill over time — and that researchers were already falling behind. “We have an unknown number of people exposed to an unknown danger,” said Dr. Lynn Goldman, a professor at the Bloomberg School of Public Health at Johns Hopkins University, at the conference. “There has not been preparedness in the public-health community for dealing with something of this magnitude.”

According to Daily Finance:

From the few studies of past spills, one of them by the National Institute for Occupational Safety and Health (NIOSH) after the Exxon Valdez spill, certain acute symptoms were expected, and already Gulf residents and cleanup workers are experiencing them: headaches, nausea, vomiting, diarrhea, throat irritation, eye pain, coughing or choking and dizziness.

Of greater concern is a more recent study of those exposed in Spain after the 2002 Prestige oil tanker spill, which found an increase in DNA damage. Other potential long-term risks include lung, kidney and liver damage.

Time also notes that “In the wake of the Exxon Valdez spill, the small Alaskan fishing port of Cordova saw a rise in domestic abuse, alcoholism and eventually suicide.”

And now perhaps more?

Brace yourself.  In the wake of the BP disaster (seriously, it’s not a “spill” anymore) an AP investigation has discovered there are 27,000 abandoned gas and oil wells in the Gulf of Mexico, some of which date back to the 1940s.  3,500 of those wells have been “temporarily abandoned” — as in, a company has told our government that it plans to reuse or permanently close a well within 12 months.  The now infamous BP well was being capped for temporary abandonment when it blew (click here to see how much land the oil would cover if it the blowout had occurred near you).  Yet three-quarters of the 3,500 temporarily abandoned wells have been left in limbo, anywhere from one year to 40.

Abandoned wells, including those “permanently” abandoned, can weaken from exposure to sea water, underground pressure, poor workmanship, age, and other factors.  The AP reporters found that neither industry nor government officials are in the habit of inspecting them.  Eric Kazanis, a U.S. Mineral Management Service petroleum engineer (whose department was recently renamed the Bureau of Ocean Energy Management, Regulation, and Enforcement), said that “[o]nce a well is plugged with cement, it’s no longer a risk….  It’s not supposed to leak.”

Yet warnings on the environmental risks of abandoned wells — published by the Government Accountability Office, the Environmental Protection Agency, and even the former Mineral Management Service — have been repeatedly ignored.  The AP reporters found that:

[s]tate officials estimate that tens of thousands [of wells] are badly sealed, either because they predate strict regulation or because the operating companies violated rules.  Texas alone has plugged more than 21,000 abandoned wells to control pollution, according to the state comptroller’s office.

Offshore, but in state waters, California has resealed scores of its abandoned wells since the 1980s.

In deeper federal waters, though… the official policy is out-of-sight, out-of-mind.

In light of this stunning revelation, Colorado Senator Mark Udall (a proponent for renewable energy)  immediately wrote to Interior Secretary Ken Salazar asking if any of the abandoned wells are in federally regulated waters, what environmental threat they might pose, and how the department may be obligated to respond.

Let’s hope the response is a little faster than what we’ve been witnessing in the Gulf so far.  By the way, BP is expected to attempt to “bottom kill” its well in the next couple of weeks.  I’m not holding my breath on either count. But perhaps– considering the the acute symptoms of exposure, Gulf residents should.

Fast Food, Childhood Obesity & the Hidden Costs of that Free Toy

Late last month, a consumer advocate group called the Center for Science in the Public Interest (CSPI) announced its intention to sue McDonald’s for using toys to market Happy Meals to children.  In an open letter to McDonald’s, CSPI litigation director Stephen Gardner alleged the toys were part of an unfair and deceptive marketing tactic which gave children “pester power” and taught them unhealthy eating habits.  Mr. Gardner further alleged the company violated Massachusetts, New Jersey, Texas, and California consumer protection laws.  Apparently McDonald’s recent Shrek 3 toy promotion was the final straw (and, somehow, the risk of cadmium exposure isn’t a concern here).  In a follow-up press release, Mr. Gardner also compared McDonald’s to:

… the stranger in the playground handing out candy to children.  McDonald’s use of toys undercuts parental authority and exploits young children’s developmental immaturity — all this to induce children to prefer foods that may harm their health.  It’s a creepy and predatory practice that warrants an injunction.

McDonald’s must decide later this month whether it will continue its Happy Meal toys or succumb to pressure.  So far the company believes that “[g]etting a toy is just one part of a fun, family experience….”

Before you completely write-off this lawsuit and characterization as over-the-top theatrics, just remember that CSPI already has a proven track record.  In 2006, the group sued KFC for using partially hydrogenated oils to deep-fry its food.  KFC subsequently switched to a trans-fat-free frying oil.  That same year CSPI also negotiated a settlement agreement with the Kellogg Company which set certain nutrition standards for marketing to children.  Better not tell CSPI about Cracker Jack and removable tattoos or Topps baseball cards and chewing gum.

In all fairness, CSPI isn’t the only group focusing on marketing to children.  Earlier this year in California, the Santa Clara County Board of Supervisors banned the inclusion of toys with meals numbering 485 calories or more.  Granted, Supervisor Donald Gage voted against the ordinance because “[i]f you can’t control a 3-year-old child for a toy, God save you when they get to be teenagers.”  The Los Angeles Times has reported on the increasing number of fast food television advertisements directed at children, particularly non-white children.  Likewise, CNN has reported on successful junk food marketing campaigns through the use of cartoon characters.  Perhaps CSPI and its supporters should go after DreamWorks and other studios whose agents negotiate these marketing agreements.  Just a thought.

This concern over McDonald’s Happy Meals and developing good eating habits in children coincides with the Trust for America’s Health (TFAH) report “F as in Fat: How Obesity Threatens America’s Future 2010.”  The report found that 38 states have adult obesity rates above 25 percent, a sharp increase from 20 years ago when no state had an obesity rate above 20 percent.  (Click here to see how your state weighs in.)  According to TFAH executive director Jeffrey Levi:

[o]besity is one of the biggest public health challenges the country has ever faced, and troubling disparities exist based on race, ethnicity, region, and income….  Millions of Americans still face barriers — like the high cost of healthy foods and lack of access to safe places to be physically active — that can make healthy choices challenging.

The report suggested a connection between income disparities and adult obesity: “35.3 percent of adults earning less than $15,000 per year were obese compared with 24.5 percent of adults earning $50,000 or more per year.”  The report also showed that “more than 12 million children and adolescents are considered obese” and half of Americans believe this is an important issue to address.  However, rather than suggesting that consumers sue fast food and junk food companies, the report recommended investing in public health initiatives and prevention programs.

I’m not a parent, so I won’t preach about better parenting skills when it comes to “pester power” and how a child’s eating habits are determined as much by their parents as the cartoon characters selling the food.  I’ll just say that there was seldom any debate with my parents over the foods that I ate as a child.  Admittedly, there sometimes are no other alternatives.  Whether you’re a high school athlete on the road, a parent with no time to make dinner, or looking for an inexpensive meal, fast food is the cheap and easy way to go.  Perhaps the key is moderation?

Does this mean CSPI should hold the fast food (and junk food) companies responsible for the development of our eating habits, from childhood to adulthood?  The TFAH report also referred to obesity liability laws in 24 states protecting restaurants, manufacturers, and marketers from weight-related lawsuits.  Take note, CSPI.  (And you, dear reader, take note of Michael Ricciardelli’s post containing some staggering numbers relating to the healthcare costs of managing Type-2 diabetes, in which obesity plays a factor, and Professor Pasquale’s beverage tax utilitarian calculus.)

San Francisco Has Cancer on the Brain

Recently, the San Francisco Chronicle reported that the city’s Board of Supervisors has thrown its hat into the ring of the great cell phone brain cancer debate.  The Board voted 9-1 in favor of an ordinance requiring local retailers to display specific absorption rate (SAR) notices detailing radiation levels in cell phones.  SAR measures the rate at which radiofrequency electromagnetic energy is absorbed in a body when using a cell phone.  The FCC requires that cell phones sold in the U.S. not exceed a SAR level of 1.6 watts per kilogram.  (If you’re curious about your own cell phone, check out CNET’s SAR level list for voice calls).  Mayor Gavin Newsom is expected to sign off on the ordinance and his spokesman says “this is a very reasonable and quite modest measure that will provide greater transparency and information to consumers for whom this is an area of interest or concern.” If this really does come through, it won’t affect retailers until 2011 or so.

Meanwhile, the industry trade group CTIA-The Wireless Association has issued a statement admonishing and punishing the Board for its vote:

“CTIA and the wireless industry are disappointed that the San Francisco Board of Supervisors has approved the so-called ‘Cell Phone Right-to-Know’ ordinance.  Rather than inform, the ordinance will potentially mislead consumers with point of sale requirements suggesting that some phones are ’safer’ than others….  [A]ll phones sold legally in the U.S. must comply with the Federal Communications Commission’s safety standards….  While we have enjoyed bringing our three day fall show to San Francisco five times in the last seven years, which has meant we’ve brought more than 68,000 exhibitors and attendees and had an economic impact of almost $80 million to the Bay Area economy, the Board of Supervisors’ action has led us to decide to relocate our show [starting in 2011].”

So is this just fear-mongering or does San Francisco’s Board know something that the rest of us don’t?  According to the 10 year Interphone study conducted by the World Health Organization’s International Agency for Research on Cancer and published online last month by the International Journal of Epidemiology, there is no conclusive evidence supporting or disaffirming any connection between cell phones and the risk of brain tumors.  The study was not without controversy, though, even among the researchers themselves — and it had nothing to do with industry trade organizations– the Mobile Manufacturers’ Forum and the GSM Association– contributing funds for the study.  Last month, the Wall Street Journal reported that the Interphone researchers were puzzled by their data because

[t]he result is a strange set of numbers.  Many levels of cellphone use appeared to reduce the chance of developing a tumor.  Only the people who talked on cellphones the most had a significantly greater chance of developing glioma [a type of tumor] - 40% greater - than those who didn’t use cellphones.

The use of cell phones might reduce the chance of developing a brain tumor?  Go figure.  For now, our very own FDA supports the Interphone study and refers to others which have shown no increased health risk.

Perhaps San Francisco politicians and consumers, like the rest of us, are really just facing a case of caveat emptor.  However, until there is a study which can definitively support or disaffirm any connection between cell phones and the risk of brain tumors,  I wouldn’t mind knowing whether one phone has a higher or lower SAR level than another.  CTIA needn’t worry though.  Having such information won’t make me break my contract with AT&T or stop me from eagerly awaiting the arrival of my iPhone 4 (whose SAR level, according to FCC documents, appears to be lower than my current iPhone 3G but higher than the iPhone 3GS).  At least I’ve now given some thought about the risks to which I may be exposing myself.  So too have the folks in San Francisco.

Balancing Patient Demands and Physician Orders for Radiation Tests at the ER and Elsewhere

[Ed. Note: We are pleased to welcome Jennifer Jascoll to HRW. She is a second-year evening student at Seton Hall Law and a Research Assistant for the school’s Healthcare Compliance Certification Program.  She received her bachelor’s degree in Political Science from Bryn Mawr College and her master’s degree in Comparative Politics (Empire) from the London School of Economics and Political Science.]

Falling down stairs.  Hitting my head on a bowling ball.  Breaking my ankle and tearing two ligaments.  These are a few of the incidents that have landed me in the emergency room with a CT scan or an X-ray.  The AP has recently run four thought-provoking articles about the problems of balancing necessary and unnecessary tests administered during visits to the ER and elsewhere.

When should a person go to the ER? The American College of Emergency Physicians Foundation and other sources provide “tips” about the necessity of an ER visit when a person experiences symptoms such as:

• Difficulty breathing or shortness of breath
• Chest or upper abdominal pain or pressure lasting two minutes or more
• Loss of consciousness or sudden dizziness and weakness
• Confusion or changes in mental status

Fair enough.  The Foundation further advises patients to lower costs and “avoid unnecessary tests and procedures” by asking:

• Is this the best test or treatment?
• What are its costs, benefits, and risks?
• Are there alternative tests that are cheaper or less risky?
• Why do I need this test now, and what would happen if I don’t get it now?

Seems like common sense.  But just how many of us question the tests and procedures we undergo at the local ER?  Probably as many who think to ask whether our attending ER physician, in addition to the ER itself, is covered by our insurance.  After all, if a person is experiencing dizziness and confusion after hitting her head on a bowling ball, I doubt she will haggle over the necessity of a CT scan (or whether her attending physician is covered, which my father later tackled with the insurance company).

These tips may not get patients very far, however, as many ER physicians are said to overtest and overtreat for fear of malpractice lawsuits.  Lindsey Tanner, an AP reporter, writes that:

[t]he fear of missing something weighs heavily on every doctor’s mind.  But the stakes are highest in the ER, and that fear often leads to extra blood tests and imaging scans for what may be harmless chest pains, run-of-the-mill head bumps, and non-threatening stomachaches.

Maybe there shouldn’t be too much surprise here.  According to Dr. Angela Gardner, president of the American College of Emergency Physicians, ER physicians are among the 10 specialists most likely to be sued:

Our society puts more weight on technology than on physical exams….  In other words, why would you believe a doctor who only examines you when you can get an X-ray that can tell you something for sure?

Increased patient demand for imaging tests coupled with a concern that not placating that demand will create unhappy and litigious patients would also seem to play a role.

Overtesting doesn’t just apply to ER visits.  AP medical writer Marilynn Marchione reports a trend in this country favoring imaging tests over physical examinations, in particular the CT scan which requires radiation (as opposed to the ultrasound or the MRI which does not).  You can receive 10-20 millisieverts (measurement for radiation dose) from a single chest or abdominal CT scan.  Compare that number to the 2 millisieverts you receive from exposure to the sun and soil every year.  Have one or two CT scans in a year and you’re looking at 20-40 millisieverts or 10-20 times your annual exposure to natural background radiation.  (For a list of other comparisons, click here.)

Our citizens receive more medical radiation than those in any other country and no one — neither physicians nor patients — really seems to be keeping track of the dose accumulation.  At least for the moment.  Marchione writes that:

[d]octors don’t keep track of radiation given their patients — they order a test, not a dose.  Except for mammograms, there are no federal rules on radiation dose. Children and young women, who are most vulnerable to radiation harm, sometimes get too much at busy imaging centers that don’t adjust doses for each patient’s size.

That may soon change….  FDA officials [have] described steps in the works, including possibly requiring device makers to print the radiation dose on each X-ray or other image so patients and doctors can see how much was given.

The FDA also is pushing industry and doctors to set standard doses for common tests such as CT scans.

There are efforts to educate patients on the risk of side effects from unnecessary radiation exposure in order to curb demand.  AP medical writer Lauran Neergaard reports on a Minnesota health cooperative which displays national radiology guidelines in a patient’s electronic medical records whenever a physician orders a scan.  The guidelines help physicians deal with patient pressure and determine whether a radiation scan is necessary.  The cooperative estimates it prevented 20,000 unnecessary tests and saved $14 million through this process.  Archives of Internal Medicine, an American Medical Association journal, also started a “Less is More” feature which, according to editor Dr. Rita F. Redberg, offers articles “that document cases in which less health care results in better health and offer[s] commentary on the specific implications.”

Patients are advised to question the necessity of a radiation scan and physicians are advised to reconsider ordering one, but just how many will do so and what will it really take to get people to listen on a national scale?

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