|Given the active and early election campaign and the emergence of health care as the No. 1 domestic issue, health-related topics grabbed many headlines over the past year. Recurring themes included health reform, changes in disease prevalence, and that perennial problem, drug safety. Here, in approximate chronological order, is a recap of the issues that got much ink and provided fodder for policy wonks and talking heads. (See the August 2007 Health Letter for a glossary of...|
|Given the active and early election campaign and the emergence of health care as the No. 1 domestic issue, health-related topics grabbed many headlines over the past year. Recurring themes included health reform, changes in disease prevalence, and that perennial problem, drug safety. Here, in approximate chronological order, is a recap of the issues that got much ink and provided fodder for policy wonks and talking heads. (See the August 2007 Health Letter for a glossary of frequently-used terms in the health care debate.)|
"Health care reform is in the air,” wrote Paul Krugman in The New York Times on January 1st. Indeed, the year began with stirrings that the push for universal health coverage would begin anew in 2007. Democrats began talking about extending coverage to all children, potential presidential candidates such as John Edwards and Hillary Clinton echoed the call for health reform, and newly-installed governors resolved to cover the uninsured in their respective states.
- Confronting increasing evidence of conflicts of interest, the Food and Drug Administration (FDA) restricted those who can serve on its advisory panels: the regulatory agency prohibited those who earn more than $50,000 per year from pharmaceutical and other enterprises regulated by the agency from serving as consultants and advisors to FDA staff members, with what they described as “rare exceptions.”
- Breast cancer deaths dropped, the decline being attributed to increased screening and, more importantly, the reduction in the number of women on hormone-replacement therapy (HRT). The decline was 8.6 percent between 2001 and 2004; this drop meant that in 2003 and 2004 there were 30,000 fewer deaths than would have occurred if previous trends had continued unabated. Additional studies coming out in the course of the year confirmed both the decline and its likely association with the lower use of HRT.
- Data suggested that Baby Boomers could very well be the first generation whose health was worse than their parents’. This was explained by the increase in obesity and in sedentary lifestyles.
- The diabetes drug Avandia (rosiglitazone), for which 11.3 million prescriptions were filled in 2006, was found to increase the risk of heart attacks by 43 percent in a study published in the New England Journal of Medicine. The publication of this finding had numerous repercussions: sales of the drug plummeted, GlaxoSmithKline stock decreased precipitously, study subjects in ongoing trials of the drug dropped out, and the FDA called for a black box warning for both Avandia and similarly-acting Actos, indicating that both drugs were “associated with an increased risk” of heart failure. More recently, a tepid warning about increased risk of heart attacks with Avandia was ordered by the FDA. Still, the FDA’s drug safety oversight board narrowly voted in favor of keeping the drug on the market; the final vote was eight to seven. (See article on page 3 of this issue about Avandia updates.)
- Michael Moore’s movie “Sicko” furthered the debate on health reform in the U.S. While critics and policy analysts predictably differed on their appraisal of the film, most agreed that the movie raised important questions concerning our broken health system and who we are as a people.
- Alli (orlistat) became the first (and only) over-the-counter weight-loss drug available in the U.S., entering the market despite serious concerns about its efficacy, disturbing side effects and the fact that it has caused pre-cancerous changes in the colons of animals. Marketed together with a kit providing advice on exercise and healthy diets, the drug is aimed at those who are committed to following a reduced-calorie, low-fat diet in addition to taking the drug.
- On July 1, new legislation came into effect which required most Massachusetts residents to be insured or pay a penalty. Hailed as the triumph of caring consensus over partisan bickering, the bill creating the Massachusetts plan nevertheless had a number of undefined provisions that caused problems in implementation. The state ended up exempting 60,000 residents because they could not afford any of the offered health plans, thereby seriously undermining its hopes for universal coverage.
- The State Children’s Health Insurance Program (SCHIP) came up for re-authorization, igniting a Congressional battle between those who wanted to extend coverage by raising the income threshold for eligibility and those who feared “crowd out” (i.e., beneficiaries foregoing private coverage to enroll in the public program). President Bush, squarely on the side of the latter, vetoed the legislation, only the fourth such action during his tenure. Overriding the veto would have required a two-thirds majority in both houses, which the bill’s supporters were not able to muster.
- We have heard a lot about the “obesity epidemic” but the term acquired new meaning in 2007: it referred not to the rising prevalence of overweight people, but rather to the process by which they got there. The idea of obesity being “contagious” (i.e., spread like an epidemic among contiguous or affinity groups) entered the popular conscience and vocabulary. Researchers found that weight depends on behaviors of people that are up to three degrees removed in a social network, and that these networks amplify the behaviors with which they are seeded. The good news: weight reduction can spread through the same pathways, and the current epidemic can be controlled and even reversed through similar mechanisms.
- The FDA increased the fees it charges pharmaceutical and device companies to review their applications. While the Prescription Drug Users’ Fee Act (PDUFA) was enacted in 1992, its reauthorization in September 2007 in effect strengthened the conflicts of interest inherent in a regulatory agency relying on those it regulates for part of its budget. Public Citizen’s Health Research Group expressed its opposition to PDUFA early and forcefully, urging its repeal and underlining that the reauthorization bill “favors drug approval at the expense of drug safety.” As of this year, the majority of funds to pay for the drug review process at the FDA comes directly from the industry.
- Facing imminent action by the FDA, a number of drug manufacturers voluntarily recalled a small number of infant cough and cold medicines. The recall included medications produced under the brand names of Dimetapp, Little Colds, Pediacare, Robitussin, Triaminic and Tylenol. Between 1969 and 2006, there were 54 reported deaths associated with the use of decongestants, and 69 associated with the use of antihistamines. Citing studies showing that the remedies were not only unsafe but also no better than a placebo, an FDA advisory panel voted to ban over-the-counter cough and cold medicines for children younger than 6. The ban applies to medicines containing at least one of the following: decongestants, expectorants, antihistamines and antitussives. Public Citizen’s Health Research Group recommends that no cough and cold medicines be given to children under 12, citing evidence that the remedies are of no benefit to older children either.
- Methicillin-resistant staphylococcus aureus (MRSA) emerged again as a deadly “superbug,” responsible for more than 94,000 serious infections and nearly 19,000 deaths each year. The pathogen, which thrives in hospitals, clinics and dialysis centers, has elicited concern intermittently. It was recognized as a major threat only after researchers assessed its actual toll, publishing their results in the Journal of the American Medical Association.
- In a $4.85 billion settlement, Merck agreed to pay 47,000 plaintiffs who used the painkiller Vioxx (rofecoxib), which was withdrawn from the market because it caused heart attacks and strokes. The settlement was widely seen as a victory for the company, which cut its losses and ended the public relations nightmare resulting from individual lawsuits. Company shares rose 2.1 percent following the settlement. Public Citizen attacked the settlement as being too small and thus unfavorable to too many injured patients.
- Not satisfied with the two basic classes of pharmaceuticals – prescription and over-the-counter – the FDA proposed a “behind the counter” category for drugs that would require the advice of a pharmacist but no medical prescription. (At present, only the emergency contraceptive Plan B is sold “behind the counter,” but this is only to check the age of the person to make sure that they are 18 or older, not to involve a pharmacist, and is a measure taken for political rather than medical reasons). The proposal was supported by pharmacists who saw this as a way to safeguard patient safety and bolster their professional status. It was opposed by the over-the-counter industry, which does not want access to its products curtailed in any way. Public Citizen testified against the adoption of the new class on other grounds. Citing a GAO study of 10 countries that have a behind-the-counter provision, Dr. Sidney Wolfe called the proposal “neither new nor good”: the experience in the countries that have the proposed class showed that it did not increase the public’s access to drugs, and had no effect on costs. Moreover, counseling by pharmacists was infrequent and incomplete, which is not surprising given their limited time and lack of reimbursement.