Tuesday, October 27, 2009
Cereal manufacturers market their least healthy products to children according to a study by Yale University’s Rudd Center for Food Policy and Obesity, Yale University. The FOODnavigator-USA.com reports on the study:
Researchers found that cereals marketed directly to children have 85 percent more sugar, 65 percent less fiber, and 60 percent more sodium than cereals marketed for adult consumption. In addition, of the 19 cereal brands that were marketed directly to children, not one meets the nutrition criteria required to advertise to children in the United Kingdom. But every one meets industry’s own standards for ‘better-for-you’ foods, the report said.
“In spite of their pledges to reduce unhealthy marketing to children, the large cereal companies continue to target children with their least healthy products,” it said. Researchers analyzed 277 individual cereal varieties across 115 brands. Brands were identified as ‘child brands’ if they were marketed directly to children on television, the internet, or through licensed characters, such as Dora the Explorer. They found that preschool-age children in the US see an average of 642 cereal commercials a year on television alone, “almost all for cereals with the worst nutrition rankings.”
Director of the Rudd Center for Food Policy and Obesity Kelly Brownell said: “Ceding authority to the food companies to regulate themselves is a mistake. The companies want to be seen as public health allies making good faith efforts to change, but their actions indicate otherwise.” Six of the ten cereals that fared worst were from General Mills, which also advertised to children more than any other cereal company. According to the report, cereal companies spend almost $156m a year on advertising to children
Thursday, October 22, 2009
Survival after surgery appears higher at teaching hospitals than at non-teaching hospitals, but this benefit is experienced by white patients and not black patients, according to a report published in February of 2009 called Silber et al., Hospital Teaching Intensity, Patient Race, and Surgical Outcomes, 144 Arch Surg. 113-20 (2009).
While the teaching versus non-teaching setting was not associated with different rates of complications for either white or black patients, whites are less likely to die following complications at teaching hospitals, a survival benefit not seen for black patients.
Putting this report together with the new study Ghaferi, A. et al., Variation in Hospital Mortality Associated with Inpatient Surgery 361 N.Eng. J. Med. 1368-75 (2009) discussed in my post, High Post-Surgical Mortality Rates Related to Failure to Rescue, and it appears that whites are being rescued from post-surgical complications while blacks are not.
ScienceDaily reports on the study of teaching hospitals and explains that
[l]ower death rates at teaching hospitals might result from preventing complications or preventing death after complications (preventing a failure-to-rescue). "While teaching hospitals are generally larger and have more advanced technology, greater volume and better nurse staffing (attributes that may aid in both preventing complications and successfully treating complications), it is by no means clear whether all patients benefit equally from these attributes," the authors write.
Jeffrey H. Silber, M.D., Ph.D., and colleagues from the Center for Outcomes Research at The Children's Hospital of Philadelphia and the University of Pennsylvania, analyzed Medicare claims from 4,658,954 patients ages 65 to 90 who underwent general, orthopedic or vascular surgery at 3,270 acute care hospitals in the United States between 2000 and 2005. They compared rates of death within 30 days, in-hospital complications and the probability of death following complications between hospitals based on teaching intensity (defined as the number of resident physicians per hospital bed). Among all hospitals and all surgical procedures combined, the overall 30-day mortality rate was 4.23 percent, complication rate was 43.39 percent and rate of death occurring after complications was 9.75 percent.
"Combining all surgeries, compared with non-teaching hospitals, patients at very major teaching hospitals demonstrated a 15 percent lower odds of death, no difference in complications and a 15 percent lower odds of death after complications (failure to rescue)," the authors write. The associations were adjusted for patient illness on admission and did not change even when the researchers considered income, suggesting that the differences in death after complications is not due to unequal access to teaching hospitals between patients in different economic classes.
However, the survival benefits associated with teaching intensive hospitals were not experienced by black patients, who had similar odds of death, complication and failure-to-rescue at teaching and non-teaching hospitals. Furthermore, such differences were apparent even when analyses compared white and black patients inside the same hospital. There are several possible reasons for this disparity, the authors note.
One previous study reported black patients experienced longer delays before beginning defibrillation than white patients, suggesting potential differences in levels of monitoring. "Unintentional differences in communication might lead to less appropriate or less accurate monitoring of black patients or less involvement in their care by personnel who could make a difference in reducing failure to rescue," the authors write. There could also be varying levels of involvement by physicians-in-training in the care of patients in different racial groups, they note.
The WSJ Health Blog reports that the new figures on medical school applications from the Association of Medical Colleges came out on Tuesday. They show that the ratio of applications per available slot has stayed essentially the same for the past decade - two applicants for every slot:
The Association of American Medical Colleges: 42,269 applicants for 18,390 first-year slots. That compares to 38,443 applicants for 16,221 slots in 1999. are out today from the
Despite the long-term stability, there are some year-to-year variations. Between 2008 and 2009, the number of applicants didn’t change much. But there are about 350 more first-year students this year, largely because four new med schools seated their first entering classes (some existing schools also expanded their first-year classes).
The new schools are affiliated with Florida International University, Texas Tech and the University of Central Florida; a fourth school, the Commonwealth Medical College, in Pennsylvania, is independent.
Tuesday, October 20, 2009
The assumption is that high mortality hospitals have high complication rates. But a new report, Variation in Hospital Mortality Associated with Inpatient Surgery, 361 N.Eng. J. Med. 1368-75 (2009), shows complications are common after major surgery -- about one in six patients. What distinguishes good and bad hospitals is how proficient they are at rescuing patients from those complications. Patients at high mortality hospitals are twice as likely to die from a post-surgical complication. The story in ScienceDaily explains:
The report in Thursday's New England Journal of Medicine confirms that serious complications are common after major surgery – about 1 in 6 patients – but the study shows what drives hospital mortality is failure to rescue.
Low mortality hospitals have medical teams with the ability to rescue patients by recognizing and heading off potentially catastrophic complications such as deep wound infections, pneumonia, kidney failure, blood clots, and strokes.
In spite of similar patterns of complications, patients at high mortality hospitals are nearly twice as likely to die after developing a serious post-surgical complication, according to the study. It's a new view of what defines the safest hospitals for surgery.
"The general assumption has been that high mortality hospitals simply have higher complication rates. We were quite surprised to find that that's not true," says study author John D. Birkmeyer, M.D., professor of surgery and chair of surgical outcomes research at U-M. "Our finding was what distinguishes high quality hospitals and low quality hospitals is how proficient they are at rescuing people once a complication has happened," he says.
The study used data on 84,730 patients undergoing general and vascular surgery at 186 hospitals participating in the American College of Surgeons – National Surgical Quality Improvement Program.
Monday, October 19, 2009
Swine Flu Vaccine Shortfall, H1N1 Found in U.S. Swine and Mandatory Vaccination of Health Workers in NY Blocked
Nature.com’s blog The Great Beyond calls attention to three Swine Flu stories of interest.
The first story relates to the vaccine shortfall and reports that "the US Centers for Disease Control and Prevention (CDC) now expects to have 28-30 million doses of swine flu vaccine by the end of October — down from the 45 million doses predicted in August and previous estimates of 120 million forecast earlier in the summer.”
The problem is caused by an inadequate supply of antigen. The antigen is the part of the virus that is used in the vaccine to trigger the body to create the antibodies that are necessary to the body’s immune response. See also NY Times, AFP, Reuters, and Bloomberg.
The second story relates to the discovery of the first case of H1N1 in U.S. Swine. The U.S. Department of Agriculture has announced that they may have identified cases of Swine Flu in swine at the Minnesota state fair. If confirmed, these will be the first cases of the disease among American domestic livestock. Further tests are being performed. (USDA statement).
The third story reports that a judge has issued an order halting the mandatory vaccination of health workers in New York. Three nurses who filed suit to block mandatory vaccination for both seasonal and H1N1 Flu were granted a temporary restraining order on Friday. As the New York Times reports:
The temporary restraining order by the judge, Thomas J. McNamara, an acting justice of the State Supreme Court in Albany, comes amid a growing debateabout the flu vaccine. On Friday afternoon, the State Department of Health vowed to fight the restraining order, saying that the authorities “have clear legal authority” to require vaccinations, and noted that state courts had upheld mandatory vaccinations of health care workers against rubella and tuberculosis. Justice McNamara scheduled a hearing for Oct. 30 on the three cases before him, involving the flu vaccine. The state health commissioner, Dr. Richard F. Daines, through the State Hospital Review and Planning Council, issued a regulation on Aug. 13 ordering health care workers to be vaccinated by Nov. 30 or face fines. Dr. Daines later explained the reasoning behind the vaccine, saying in a statement on Sept. 24: Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination – not the 40-50 percent rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed. Terence L. Kindlon, a lawyer for three nurses who sued the state, asserting that the order violated their civil rights, said the judge’s ruling was a victory. New York was the only state in the country to mandate vaccinations for health care workers, he said. [KVT]
The third story reports that a judge has issued an order halting the mandatory vaccination of health workers in New York. Three nurses who filed suit to block mandatory vaccination for both seasonal and H1N1 Flu were granted a temporary restraining order on Friday. As the New York Times reports:
The temporary restraining order by the judge, Thomas J. McNamara, an acting justice of the State Supreme Court in Albany, comes amid a growing debateabout the flu vaccine. On Friday afternoon, the State Department of Health vowed to fight the restraining order, saying that the authorities “have clear legal authority” to require vaccinations, and noted that state courts had upheld mandatory vaccinations of health care workers against rubella and tuberculosis. Justice McNamara scheduled a hearing for Oct. 30 on the three cases before him, involving the flu vaccine.
The state health commissioner, Dr. Richard F. Daines, through the State Hospital Review and Planning Council, issued a regulation on Aug. 13 ordering health care workers to be vaccinated by Nov. 30 or face fines.
Dr. Daines later explained the reasoning behind the vaccine, saying in a statement on Sept. 24:
Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination – not the 40-50 percent rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed.
Terence L. Kindlon, a lawyer for three nurses who sued the state, asserting that the order violated their civil rights, said the judge’s ruling was a victory. New York was the only state in the country to mandate vaccinations for health care workers, he said.
Sunday, October 18, 2009
According to the HealthGrades Report on patient outcomes at 5000 hospitals, the quality gap continues. Patients who have access to high quality hospitals have a 52% lower chance of dying.
- Overall, inhospital, risk-adjusted mortality at the nation's hospitals improved, on average, 10.99% from 2006 through 2008.
- Across all 17 procedures and diagnoses in which mortality was studied, there was an approximate 71.64% lower chance of dying in a five-star rated hospital compared to a one-star rated hospital.
- Across all 17 procedures and diagnoses studied, there was an approximate 51.53% lower chance of dying in a five-star rated hospital compared to the national average.
- If all hospitals performed at the level of a five-star rated hospital across the 17 procedures and diagnoses studied, 224,537 Medicare lives could potentially have been saved from 2006 through 2008.
- Approximately 57% (127,488) of the potentially preventable deaths were associated with just four diagnoses: sepsis (44,622); pneumonia (29,251); heart failure (26,374) and respiratory failure (27,241).
- Over the last three studies, Ohio and Florida consistently have had the greatest percentage of hospitals in the top 15% for risk-adjusted mortality.
- Across all procedures in which complications were studied, there was a 79.69% lower chance of experiencing one or more inhospital complications in a five-star rated hospital compared to a one-star rated hospital.
- Across all procedures studied, there was a 61.22% lower chance of experiencing one or more inhospital complications in a five-star rated hospital compared to the U.S. hospital average.
- If all hospitals performed at the level of a five-star rated hospital, 110,687 orthopedic inhospital complications may have been avoided among Medicare patients over the three years studied.
- Joint Commission stroke-certified hospitals were almost twice as likely to attain five-star status in stroke (30.1% of certified hospitals were five-star versus 15.7% of non-certified), and fewer of the stroke-certified hospitals fell into the one-star category (12.3% versus 19.6%).
- Joint Commission stroke-certified hospitals have an 8.06% lower risk-adjusted mortality rate compared to hospitals that were not stroke-certified.
The HeathGrades Report is based on the following process:
HealthGrades rates each of the nation's 5,000 nonfederal hospitals in nearly 30 procedures and diagnoses, allowing individuals to compare their local hospitals online at http://www.healthgrades.com. The ratings are objective, created from data provided by the Centers for Medicare and Medicaid Services and 17 states that publish outcomes data. HealthGrades' hospital ratings are independently created; no hospital can opt-in or opt-out of being rated. No hospital pays to be rated. Each hospital receives a one-, three- or five-star rating for each procedure or diagnosis, reflecting the mortality or complication rates at that hospital. Mortality and complication rates are risk-adjusted, which takes into account differing levels of severity of patient illness at different hospitals and allows for hospitals to be compared on equal footing.
Friday, October 16, 2009
What does it mean when expert psychiatric witnesses in a court case reach opposing conclusions on the same sets of evidence? Does it mean that one side or the other is necessarily being less than honest? According to a report in ScienceDaily, a new study suggests via mathematical modeling that both analyses can be completely accurate.
The study which was published online in Law and Human Behavior, the journal of the American Psychology-Law Society was led by Douglas Mossman, MD, director of the UC College of Law’s Glenn M. Weaver Institute of Law and Psychiatry and the forensic psychiatry fellowship at the UC College of Medicine. The study looked at a group of psychiatrists who evaluated mental competence from case files of 156 criminal defendants and concluded that the group performed at a strikingly high level of accuracy.
In an average of 29 out of every 30 cases, the psychiatrists could distinguish competent defendants from incompetent defendants. That’s a level of performance that exceeds standard diagnostic performance in other areas of medicine, such as spotting breast cancer in mammograms or using advanced imaging methods to detect Alzheimer’s disease.
“These results help us see how courtroom experts can be quite accurate in distinguishing competence from incompetence, but still reach different conclusions,” says Mossman of the study, which was published online in Law and Human Behavior, the journal of the American Psychology-Law Society. “It’s a matter of where experts draw the line on the issue of competence.”
Continues Mossman: “Experts may disagree with each other even though they are very good at making all the right distinctions. You’re apt to get disagreement when you ask experts for a ‘yes’ or ‘no’ answer, as the courts do, on issues that can have gray areas, like competence to stand trial.”
The problem is there is no independent, infallible “gold standard” to establish conclusions in forensic psychiatry, as there is in most other areas of medicine.
“If there were some way, however, to measure accuracy without a ‘gold standard,’ mental health experts might be more credible,” Mossman says. “Over the last two decades, statisticians have developed mathematical techniques that – in some cases – make it possible to estimate diagnostic accuracy without gold standards.”
These techniques – which have been successfully used in areas as diverse as imaging liver cancer and detecting infections in dairy cattle – form the backbone of the study. Using statistical methods known as latent class modeling, the study looked at the performance of psychiatrists who made evaluations based on the 156 case files presented to them.
“The techniques are applicable to lots of questions in law and mental health,” Mossman says. “There are many, many other kinds of cases where courts depend on mental health experts’ opinions. If you have the right kind of data, these methods would allow you to evaluate the accuracy of court evaluations.”
Mossman, himself an experienced psychiatric expert from dozens of court cases, says that by using this method to establish the accuracy of experts, the value of their opinions can be demonstrated and even assigned a mathematical quantity. But experts are still going to reach different conclusions.
“The legal system asks experts to give ‘yes’ or ‘no’ answers, but that’s not how things usually are in medicine,” he says. “Very often, a physician’s diagnostic judgment really is a probability, an in-between answer. In courtroom testimony, experts are supposed to provide a clear opinion, not an ambiguous answer, even when the problem involves a shade-of-gray kind of question. That’s where the real opportunity for difference of opinion comes into play.”
Thursday, October 15, 2009
Statehealthfacts.org, which is part of the the Kaiser Family Foundation website, has recently added new and updated data on Demographics and the Economy, Health Coverage & Uninsured, Medicaid & CHIP, Medicare,Providers & Service Use, and Minority Health.
- Population Characteristics
The latest demographic data for the population including age, gender, citizenship status, family structure, income, metropolitan area, and race/ethnicity based on analysis of the Census Bureau’s 2009 Current Population Survey (CPS) by the Kaiser Commission on Medicaid and the Uninsured and the Urban Institute are now available for all states and the nation. Updated demographic data on people living in povertyare also available for all states.
- Households in Poverty
Updated data from the Census Bureau on poverty rates and median incomes based on household income have been added for 2006-2008 and 2007-2008 for all states and the nation.
- Employment Status
Updated household employment data from the Bureau of Labor Statistics (BLS) on workers represented by unionsfor 2008 have been added and are available for all states and the nation. The 2008 state-by-state distribution of workers by occupationalcategory based on the 2009 CPS is also available by state.
The latest data from the BLS on unemployment rates have been added for all states and the nation for August 2009.
- Food Stamp Program
The most recent information from the United States Department of Agriculture’s (USDA) Food and Nutrition Service on monthly food stamp enrollment is now available for all states and the nation for July 2009.
- State Fiscal Distress
Aggregate state rankings in foreclosures, unemployment, and food stamp participation have been updated with the most recent unemployment data and the latest food stamp enrollment data.
- Health Insurance Status
Health coverage data for key populations - the nonelderly, children, adults, men, women, parents, and adults without dependent children– have been updated to 2008 based on analysis of the 2009 CPS by the Kaiser Commission on Medicaid and the Uninsured and the Urban Institute. New data on the health insurance status of childrenand adultsbased on income ranges outlined in health reform bills currently being debated in Congress have also been added and are available for all states and for the nation.
- Coverage Trends
Data on state and national health coverage trends from 2005-2008 and 2007-2008 based on analysis of the CPS are now available for the nonelderly, adults, and children.
- Medicaid Budget Policy
Updated data from the latest 50-state Medicaid budget survey by the Kaiser Commission on Medicaid and the Uninsured on state Medicaid budget policies to control costs in Medicaid or to expand the program are now available for state FY 2009 and FY 2010. The number of states that have implemented or proposed Medicaid cost-containment actionsrelated to provider payment changes, eligibility cuts, pharmacy controls, benefit reductions, co-pays, managed care expansions, disease and case management, fraud and abuse, and long term care are available by state. Also available is information about “positive” Medicaid policy actions, such as increased provider payments, expanded benefits, increased eligibility, and changes in the delivery of long term care services.
- Medicare Population Demographics
Updated demographic data on Medicare enrollees by age, federal poverty level, gender, and race/ethnicity based on analysis of the 2009 Current Population Survey have been added and are available for all states and the nation.
- Access to Care
Updated data from the Center for Disease Control and Prevention’s Behavioral Risk Factor Surveillance System Survey on the percentage of the adults who reported not seeing a doctor due to cost are now available for 2008.
- Health Care Employment
Updated data from the Bureau of Labor Statistics on the population employed in the health care field are now available for 2008 for all states and the nation.
- Minority Population
The latest Black, Hispanic, Asian-American/Pacific Islander, and Native American population data based on analysis of the 2009 Current Population Survey have been added for all states and the nation.
Tuesday, October 13, 2009
UK Border Agencies Start Pilot Program Using DNA Testing to Prove the Origin of Asylum Seekers Claiming to Be From Somalia
The UK Border Agency came under attack for its proposed plan to use genetics to determine nationality. According to a report in Nature, a pilot project was implemented to confirm the claims of 100 asylum seekers that they are from war-torn Somalia. The plan calls for checking the individuals for specific mutations called SNPs (single polymorphisms) in mitochondrial DNA, the Y chromosome and elsewhere in the genome. But those geneticists contacted by Nature for their views on the merits of the plan were more than skeptical. According to one geneticist “[t]he idea that genetic variability follows national boundaries is absurd.” The article goes on to explain why:
It is true that the recent development of large SNP databases have made it possible to determine the geographic origins of Europeans to within a few hundred kilometers (see Nature 456, 98–101; 2008). But comparable data on many human populations, especially in regions such as Africa, remain patchy at best, and it is unclear what data the border agency will use to establish the origins of these particular asylum-seekers.
On a more fundamental level, the idea that genetic variability follows man-made national boundaries is absurd. Cross-border migration is common throughout the world; Y-chromosome analysis can easily be thrown off by a distant male ancestor; and SNP-based identifications are inexact to say the least. As an example of this last point, individuals whose parents come from two geographic regions are often classed into a third region from which neither parent originated.
These problems seem to be ignored in the guidelines provided to border agents testing the asylum-seekers. Given the scientific credibility of DNA evidence, it is not difficult to imagine that these agents — who are presumably not geneticists — might place undue weight on results that are, at best, difficult to interpret and, at worst, spurious.
Migration organizations and geneticists alike have been vocal in their protests against the plan, and in response the UK government seems to have backpedalled. In a statement released earlier this week from the Home Office, which runs the border agency, the program was described as only a proof-of-concept project that would not be used to make decisions about any asylum-seeker.
Monday, October 12, 2009
Hispanic children with brain tumors have less access to specialists in neurosurgery than other children. This disparity in access could negatively impact both immediate prognosis and long-term survival according to research by a team from Johns Hopkins. The study, which was published in this October’s Pediatrics , is called Disparities in Access to Pediatric Neurooncological Surgery in the United States .
The study looked at 4,421 children with brain tumors over the span of 18 years. The study found that access was worst among Hispanics, as well as among those of lower socio-economic status and those living in areas with higher immigrant population and with few neurosurgeons.
'What was shocking to us was the finding that, despite the push over the last decade to equalize access to high-quality care, gaps are still there, particularly among Hispanics, and, if anything, they may be getting even worse,’ said lead investigator Raj Mukherjee, M.D., M.P.H., a postdoctoral fellow in the Department of Neurosurgery at Hopkins.
Research has shown that patients treated at specialty hospitals that admit a high volume of patients with similar conditions fare better in the long and short term, investigators say. For example, studies show that patients undergoing brain surgeries in hospitals that perform the fewest neurosurgeries have up to 16 times the mortality rate of patients treated in hospitals performing the highest number.
‘Given that brain tumors are the most common solid tumors in children, lack of access to specialized care simply means that thousands of pediatric patients are getting less-than-optimal treatment, putting them at risk for relapse and a host of neurological complications,’ says pediatric neurosurgeon George Jallo, M.D., co-author on the study and director of Neurosurgery at Johns Hopkins Children's Center.
Sunday, October 11, 2009
A new blog called "Legal Issues in Health Reform" was announced by Timothy Westmoreland, the Co-Director of Legal Solutions in Health Reform, O’Neill Institute for National and Global Health Law at the Georgetown University Law Center. Tim's announcement reads as follows:
The initial posts by Mark Hall and Tim Jost engage the debate over "the constitutionality of health reform," specifically the constitutionality of an individual mandate. Check it out at http://oneillhealthreform.wordpress.com.
One of the primary purposes of the blog is to create a venue for more extensive analysis of legal issues that may first appear in the media.
Mark's and Tim's posts rebut arguments - made recently in the Washington Post, Wall Street Journal, LA Times and elsewhere - that Congress lacks the constitutional authority to enact major components of reform proposals now moving through Congress. Other recent posts include discussion of whether the individual mandate is a tax, federalism and procedural due process, and a response to the proposed legislation amending health insurance anti-trust laws.
As health reform legislation continues to develop and move forward, the O'Neill blog will be a community resource for thoughtful analysis of the legal issues presented in the various bills. You can sign up for the blog's RSS feed as a way to conveniently follow these important debates. And feel free to join the discussion - the blog is open to comments from the public.
Saturday, October 10, 2009
This interactive side-by-side compares the leading comprehensive reform proposals across a number of key characteristics and plan components. Included in this side-by-side are proposals for moving toward universal coverage that have been put forward by the President and Members of Congress. In an effort to capture the most important proposals, we have included those that have been formally introduced as legislation as well as those that have been offered as draft proposals or as policy options. It will be regularly updated to reflect changes in the proposals and to incorporate major new proposals as they are announced. This side-by-side offers a summary of the major components of these proposals; detailed descriptions of provisions relating to the Medicare and Medicaid programs can be found online.
Thursday, October 8, 2009
A Challenge to the FDA’s Entire Regulatory Scheme for Health Care Products: Botox Manufacturer Files Lawsuit Asserting First Amendment Protection for Off Label Drug Claims
In a move that could undermine the entire FDA premarket approval process for all health care products, the maker of Botox has filed a legal action against the government claiming first amendment protection for the distribution of “truthful, relevant information” to doctors regarding off-label uses of its drugs.
As Natasha Singer of the New York Times reports:
The Food and Drug Administration approves medicines for specific therapeutic indications. Once a drug is approved for a specific use, doctors are then free to use their medical judgment to prescribe the drugs for other unapproved, or off-label, uses. Manufacturers, however, are prohibited from promoting off-label uses to medical providers or advertising such uses directly to the public.
Botox, an injectable drug that can temporarily reduce muscle or gland activity, is approved in the United States to treat crossed eyes, eyelid spasms, excessive sweating, severe neck contortions and wrinkles. But many doctors use the drug for unapproved indications like facial spasms, vocal cord problems and migraine headaches.
‘If you could get a drug approved for one narrow use and then market it for everything else, there would be no incentive or motivation for a company to prepare data to ensure that it meets the standard for safety and efficacy,’ said Marc J. Scheineson, a lawyer specializing in food and drug regulation at Alston & Bird in Washington.
It appears that the Botox suit is claiming free speech protections that are similar to those provided for dietary supplements. See Pearson and Shaw v. Shalala, 1999 U.S. App. LEXIS 464 (Jan. 15, 1999). However, dietary supplements are targeted to healthy portions of the population to help maintain or enhance health. Drugs are marketed to unhealthy, vulnerable portions of the population claim to aid in an individual’s struggle to return to normal health. This difference should be outcome determinative in the Botox case.
In an attempt to place this issue in historical context, the following provides a very brief summary of the long history of the relationship between the Food Drug and Cosmetic Act, the FDA and predatory commercial interests which suggests that there are lessons from the past that can assist in the analysis of this current regulatory issue.
Over the 100 year history of the FDA, Congress has been steadfast in balancing the protection of individual choice in matters involving self-regarding behavior, such as food choices, with the need to protect vulnerable consumers from harm from third parties who are marketing health care products. It has done so by linking the level of product regulation with the health status of the product’s targeted population. Accordingly, the greatest amount of regulatory protection has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individual’s struggle to return to normal health. Examples of products that fall into this category include drugs and devices.
For these products, the modern FDCA establishes a premarket enforcement process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process prior to distribution to the public. Without premarket approval from the FDA, these products will be deemed both adulterated and misbranded as a matter of law. Conversely, the FDCA requires less regulatory protection when products are targeted to healthy populations for use in maintaining or improving a normal state of health. Examples of products that fall into this category are foods and narrow categories of functional foods and dietary supplements. For these products, the FDA carries the burden of removing an unsafe or ineffective product by proving that it is adulterated or misbranded.
A review of the history of quack medicines supports this public health strategy. The late nineteenth and early twentieth centuries saw a remarkable growth in the marketing of sham products to treat and cure disease. At that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product. This scientific lag time created a period when there was an information void that predatory commercial interests were quick to use to their advantage. As the FDA carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial interests were able to profit from scientific uncertainty to the detriment of public health.
During this long period in U.S. history, the curative claims of predatory sham medicine salesmen were limited only by the gullibility of their targets. In many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. The more dire the condition, the more vulnerable an individual was to the ‘flim flam’ of the greedy snake oil salesman. And the more dire the condition, the greater the degree of harm when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. Thus, this lag time between initial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product’s safety and effectiveness was very costly in terms of human suffering and loss of life.
It took a series of highly publicized public health crises [including the thalidomide crisis described below] to create the political will needed to pass legislation to close this ‘space between’ created by scientific uncertainty. This was accomplished by switching the burden of proof of safety and effectiveness from the FDA and onto drug manufacturers. As more fully discussed in the following sections, it was not until 1962 that legislation was passed that required manufacturers to obtain premarket approval for new drugs from the FDA by producing “substantial evidence” that the product is both safe and effective for its intended use. The Drug Amendments of 1962 allowed the FDA to make the transition from its former inefficient and costly police role of enforcing specific statutory prohibitions by removing adulterated and misbranded products from the market, to its current gatekeeper role of preventing those products from entering the market in the first place. Thus, from 1962 until 1994 [with the passage of DSHEA dealing with dietary supplements], manufacturers were no longer able to ‘play in the grey’ and take commercial advantage of the scientific uncertainty over the safety and effectiveness of a product to the detriment of public health.
See Van Tassel, K.,Slaying the Hydra: The History of Quack Medicine, The Obesity Epidemic and the FDA's Battle to Regulate Dietary Supplements, 6 Indiana Health L. J. 203-251 (2009).
What the manufacturer of Botox wants to achieve is the ability for drug manufacturers to once again promote drugs while there is scientific uncertainty over their safety and effectiveness. They are taking the first step toward this goal by claiming this free speech in the context of communication to physicians. While the debate starts over this question, it will be prudent to recall the lessons taught by the Thalidomide case which occurred prior to the 1962 Drug Amendments and involved the distribution of drug to thousands of patients by doctors while there was still scientific uncertainty over its safety:
Thalidomide was widely distributed in Germany, Japan and the United Kingdom for sedative purposes and for the treatment of nausea in pregnancy for several years. In 1960, William S. Merrell Company, the manufacturer of the American version of Thalidomide, Kevadon, applied for FDA approval. However, it was clear to Dr. Frances Kelsey, one of the FDA officers examining the application, that the drug had not been adequately tested for safety before distribution. In spite of pressure to approve the drug placed by the manufacturer on both the FDA and Dr. Kelsey individually, Dr. Kelsey insisted that the drug needed additional testing to prove safety before FDA approval could be granted. In 1961, Dr. Kelsey learned of a possible connection between nerve damage in adults and Thalidomide. [These babies were born with phocomelia, which is a Greek word that combines the words ‘seal’ and ‘limb’ … where the long bones of the infants’ arms had almost completely failed to grow; their arms were so short that their hands extended almost directly from their shoulders. Their legs were less affected but showed signs of a similar distortion of growth . . . .”]. She requested that Merrell provide studies on the use of its Thalidomide product on pregnant women. In 1962, it was discovered that Thalidomide was causing serious birth defects in children. While the application for Thalidomide was pending for FDA approval, hundreds of severely deformed babies were being born in Germany. [Worldwide, it is estimated that 8,000 severely deformed babies were born because of thalidomide].Without the FDA’s knowledge, Thalidomide had already been provided to 20,000 patients in the United States as part of an “investigational study.”
Is now the time to use an emergency exception to the FDA approval process for the addition of adjuvants to the H1N1 vaccine? Some argue that this measure should be taken in the U.S. order to protect people in other countries from the flu pandemic.
What exactly are adjuvants and why are they added to vaccines? The New York Times reports that
[t]he term adjuvant, from a Latin word meaning “to help,” was coined in the 1920s by Gaston Ramon, a veterinarian at the Pasteur Institute in France, who observed that horses given diphtheria toxin had a stronger immune response if they had some inflammation at the injection site. Among his first adjuvants were bread crumbs and tapioca.... Within a few years, scientists discovered that aluminum salts could prompt an immune response. Alum, as this adjuvant is often called, is now used in various vaccines, including those for tetanus and hepatitis B. It is a relatively weak adjuvant. But about 80 years after its discovery, it is still the only one used in vaccines the United States.
What are the benefits of adjuvants?
That is the crux of a debate over adjuvants — a class of substances that somewhat mysteriously increase the potency of vaccines. Early studies suggest that adjuvants (pronounced AD-joo-vants) could allow four times as many people to be immunized against the H1N1 pandemic influenza with a given amount of vaccine. So with the world facing possibly severe shortages of vaccine, the World Health Organization and some health experts have been calling for the use of adjuvants to stretch the vaccine supply.
However, the United States appears to be hesitant to add adjuvants to its H1N1 vaccine. Some officials fear that the addition of adjuvants, with unknown risks, will add to the controversy over vaccinations generally and discourage people from getting vaccinated.
What are the potential risks officials are referring to? Reporter Andrew Pollack of the NYT explains that
[w]hile adjuvants tend to increase the temporary pain, swelling or fatigue caused by a vaccine, the main concern is whether they might cause an autoimmune disease, like rheumatoid arthritis, in which the immune system attacks the body’s own tissues. Some animal studies have suggested that possibility.
Because very little is known about our body’s immune system response to foreign substances such as adjuvants, and because the adjuvanted H1N1 vaccine has not gone through the FDA approval process, the safety of an adjuvanted vaccine is unknown. Moreover, even after the FDA approval process, there will still be a level of uncertainty over the safety of an adjuvanted vaccine for some time. This is because studies have shown that fifty percent of the side effects produced by any drug are not apparent until after FDA approval and the drug has been distributed to the population.
Because the adjuvanted H1N1 vaccine has not gone through the standard FDA approval process, its use would fall under a so-called emergency use authorization. The question becomes whether this is the time for the FDA to use its emergency approval powers?
Coupled with the unknown risks that adjuvants may harbor is the public fear that this uncertainty brings. An unintended consequence may be that the lack of empirical studies will be used by the anti-vaccine movement to bolster their cause.
The benefits and risks of adding adjuvants to the H1N1 vaccine will have to be assessed more closely in the coming weeks. The unanswered question is whether this is the time to use an emergency exception to FDA approval for adjuvants in order to protect people in other countries from the flu pandemic.
Marissa Anne Del Mauro
The non-partisan Congressional Budget Office released its much-anticipated report on the Senate Finance Committee legislation to revise the Health Care System reports the New York Times, The Washington Post, Los Angeles Times, BBC and The Wall Street Journal. The cost analysis demonstrated that the bill will reduce deficits by a total of $81 billion over the next 10 years while providing health insurance to 29 million uninsured Americans.
According to the NYT:
The report clears the way for the Finance Committee chairman, Senator Max Baucus, Democrat of Montana, to push for a panel vote within the next few days, and sets the stage for Democrats to take legislation to the floor for debate by the full Senate this month.
▪ 29 million uninsured will be covered.
▪ 25 million, one-third illegal immigrants, remain uncovered.
▪ Portion of non-elderly with insurance will increase over 10 years to 94% from 83% today.
▪ A proposed expansion of Medicaid to include an additional 14 million people will add $345 billion to federal Medicaid spending and $33 billion in State Medicaid spending over the next 10 years.
▪ Subsidies to help low and middle income people buy insurance will add $201 billion in federal costs over 10 years.
And here are the main savings and revenue provisions:
▪ A proposed tax on high-cost insurance policies would raise $201 billion over 10 years.
▪ Penalties of $750 per year would be paid by people who go without insurance would total $4 billion over 10 years (less than the $20 billion expected under the original proposal).
▪ Employers who did not provide health benefits would pay $23 billion in penalties (down from $27 billion).
▪ A Medicare commission would be created, with power to make cutbacks in the program, unless blocked by subsequent legislative action which would save $22 billion over 10 years.
▪ The bill would establish insurance cooperatives, to compete with private insurers. But the budget office said the co-ops would not establish “a significant market presence in many areas.”
▪ The budget office found that the Finance Committee would reduce payments to private Medicare Advantage plans by $117 billion over 10 years while cutting the growth of Medicare payments to other health providers by $162 billion.
Sunday, October 4, 2009
As usual, the month-to-month gain wasn’t huge — about 19,000 new health-care jobs were added during September, bringing the total to 13.67 million, according to the seasonally adjusted estimate out Friday from the Bureau of Labor Statistics.
But over the past year, with consistent gains, the sector has added about 300,000 jobs. During the same period, the total number of nonfarm jobs nationwide fell by about 6 million, to 131 million.
Every subcategory within health care showed job growth in September. The biggies: Doctors’ offices added 5,300 jobs, hospitals added 4,600 slots, home health-care services added 3,400 jobs and nursing-care facilities added 2,100 jobs.