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What Happened in Health Care in 2009

December 2009

Public Citizen Health Letter

2009 … the year that began with the promise of change! It started with speculation on key political appointments in the health arena and what these would mean. Key among these was the nomination of Tom Daschle as both White House “health czar” and Secretary of the Department of Health and Human Services. Revelations that Daschle had not paid $128,000 in back taxes forced him to withdraw after 10 days of gossip, delayed hearings, repeated Presidential and Congressional support and editorials from key media.

The rumor that Dr. Sanjay Gupta would be named Surgeon General spread throughout the media, eliciting comments from both supporters (who thought that his TV persona would be perfect for the job) and detractors (who questioned both the relevance of neurosurgery for the role of advocate for the public’s health, and the wisdom of some of his judgments). Two months later, Gupta withdrew his name from consideration.

The first food scare of 2009 involved peanut butter produced by the Peanut Corporation of America (PCA). By the third week of January, more than 500 cases of salmonella poisoning and eight deaths had been reported. Two weeks later, the number of sick reached 600. Because the company that manufactured the contaminated product sold it to more than 400 other companies, the recall also included cookies, other snacks and even pet food. Investigations revealed that the company had been cited a dozen times, and had done nothing to change its processes. Photographs of the plant in which the peanut butter was manufactured showed egregious deficiencies: leaky roofs, insalubrious manufacturing and storage facilities, pests. The pictures could not have been more eloquent. At Congressional hearings, PCA officials invoked their Fifth Amendment right to avoid self-incrimination.

The Food and Drug Administration (FDA) was further placed under a magnifying glass when the Government Accountability Office (GAO) issued a report strongly criticizing the FDA for failing to protect the public by its lax or minimal testing of medical devices. The conclusions of the report were echoed by a group of nine scientists within the FDA’s device division. In a letter to then president-elect Barack Obama and to Congress, the scientists described a corrupt review process in which medical devices are given quick approval following perfunctory testing because manufacturers tell the FDA that their products are ”me, too” devices that operate similarly as older devices that have already received agency approval. The scientists subsequently followed up their letter with a memorandum to the FDA pointing out that imaging equipment to detect breast cancer and an orthopedic knee device had been inappropriately approved by the agency. They also charged the FDA with allowing hospitals to wash and reuse surgical devices intended for one-use only.

Congress approved a $787.2 billion economic stimulus bill that included a number of health care provisions. These included $87 billion for state Medicaid programs, an allocation to promote the adoption of electronic health records and federal subsidies to extend the COBRA program.

A federal appeals court upheld the requirement that fast-food restaurants in New York include the calorie count the items on its menus. This was hailed as a victory for consumer advocates and those seeking to control the epidemic of obesity. The case was also important because other states (e.g., California, the city of Philadelphia) were awaiting the decision before adopting similar regulations. Public Citizen’s Litigation Group argued this case, winning a significant victory.

Kathleen Sebelius was named Secretary of Health and Human Services. Her prior health-related background included being insurance commissioner in Kansas and governor of Kansas. She was the last of President Obama’s cabinet to be confirmed.

The battle over health reform, a perennial issue but one that was back-burnered during the Bush years, gained new energy under the Obama-Biden administration. Unlike previous years, however, there is a growing consensus that the U.S. cannot afford to leave close to 50 million of its inhabitants uncovered. But there are a myriad issues revolving around means rather than ends, with those who want an altogether different health care delivery system pitted against those who just want more money for the inefficiency-ridden, fragmented, costly system we have now. A “Health Reform Summit” conducted in early March brought some of these issues to the fore.

In Wyeth vs. Levine, the Supreme Court ruled 6-3 in favor of allowing patients to sue in state court for harmful side effects of drugs that are not properly disclosed even if the drug has been approved by the FDA. The suit arose when Diane Levine sued Wyeth after receiving Phenergan intravenously and losing an arm to gangrene. A New York Times editorial hailed the ruling as “a win for injured patients” and a “wise and surprising decision.” The case was also deemed “the most important business case in years.” The Public Health Litigation Group was heavily involved in the case.

The desire to diversify their products in a precarious market led to major mergers in the pharmaceutical industry. Roche Holding acquired controlling shares in Genentech; Merck & Co. bought Schering –Plough for $41.1 billion; and Pfizer acquired Wyeth for $68 billion.
Citing the need to separate science from policy, President Obama reversed the Bush administration’s restrictions on federal financing for stem-cell research. The decision was generally welcomed by researchers but condemned by those who construed it as an assault on life.

The appointments of Drs. Margaret Hamburg and Joshua Sharfstein at FDA raised expectations that the agency would assign a higher priority to safety and efficacy and address the agency’s weaknesses. Evidence of some of the problems besetting the FDA emerged with the revelation that an 11-year old study linking the schizophrenia drug Seroquel to weight gain and diabetes was never published. Comparisons of Seroquel to the older drug Haldol found not only that patients on Seroquel gained an average of 11 pounds per year, but also that the new drug was not more effective than Haldol in preventing psychotic relapses. AstraZeneca, the company which produced Seroquel, never published the study results or shared them with physicians. FDA had access to the study, but the agency lacked the authority to publicize the results. AstraZeneca ended up paying the government $520 million to settle the case later in the year.

The PSA blood test, which has been used for more than 20 years to screen for prostate cancer, was found to save few lives. The test was also found to lead to risky and unnecessary treatments for many men. Two large-scale studies were conducted in the United States and Europe. The European study found that 48 men were told they can prostate cancer and needlessly treated for it for every man whose death was prevented within 10 years having undergoing a PSA. The U.S. study found no reduction in deaths for prostate cancer after the men had been followed for a decade.

The peanut scare was followed by warnings that pistachios were infested with salmonella. The problem was caught early by the firm which grows and markets the nuts. The recall of pistachios involved 31 states, and seems to have averted any outbreak of the disease. In quick succession, alfalfa sprouts were also found to be contaminated with salmonella.

Following a court ruling that the FDA decided not to challenge, the agency allowed selling Plan B (the ”morning after” contraceptive) without prescription to persons 17 years old. The prior minimum age requirement was set at 18.

At the end of April, the confirmation of 20 cases of swine flu (more accurately referred to as the H1N1 influenza) spread over 5 states led the U.S. Homeland Security Agency and the Centers for Disease Control and Prevention to declare a public health state of emergency. In Mexico, where more than one thousand cases and over 100 deaths were reported, the government instituted strict control measures, including distributing surgical masks to the population, closing schools and churches and canceling sports events, and alerting the population concerning signs and symptoms of the disease and how to protect themselves. Because the disease originally appeared to be largely confined to North America, several European countries issued travel alerts against travel to Mexico and the United States; some countries instituted quarantine measures at their borders to monitor the health of incoming visitors. The World Health Organization (WHO) issued periodic alerts ratcheting the level of concern upwards. But the strain of the virus turned out to be less virulent than anticipated, and many felt that it had been more a media than a health event. By the end of May, the U.S. could state that the emergency was over; in President Obama’s words, the correct response was one of “concern” rather than “panic.” By the end of June, however, more than 127 deaths due to H1N1 flu had been reported in the U.S. The WHO declared the flu a “pandemic” in mid-June. This did not mean that the condition was more lethal, but rather that its spread was considered unstoppable. WHO was motivated to increase the level of concern because of widespread diffusion beyond the region of origin. China, eager to avoid the panic that accompanied its cover-up of the SARS outbreak (2003), took drastic measures against H1N1, quarantining any person with a temperature and instituting other measures that the CDC considered disproportionate to the threat. International tourists were caught in the dragnet, confined to their hotels or hospitalized.

An unlikely coalition of diverse interests – including labor, the drug and device industries, and health insurance lobbyists – met with the President and other members of the Obama administration and indicated their willingness to control costs voluntarily. The industry groups later hedged on their initial pledge, which was supposed to reduce cost increases by 1.5 per cent per year and save $2 trillion over 10 years. Instead, they said they had merely agreed to work towards that eventual goal, promising no definite outcome.

The House voted to authorize the FDA to regulate tobacco products. The legislation was passed by the Senate and signed by President Obama. The law allows the agency to regulate the many of the contents of products, requires companies to make public their ingredients, prohibits most flavoring, mandates larger warnings, and controls marketing campaigns, particularly those aimed at youths. The legislation, long in coming, was considered a significant victory for the anti-smoking lobby.

In June, the FDA issued a consumer warning against the use of Zicam, a popular cold remedy, after hundreds of reports that the zinc in the drug destroyed users’ sense of smell, a condition called anosmia. Despite the FDA’s alert and having had to pay millions to settle lawsuits bought by consumers of the product who suffered damages, the manufacturer did not recall the product.

Summer began without Nestlé’s toll house cookies because the cookie dough was contaminated with E. coli. Nestlé’s recalled its product after receiving reports of illness from 66 persons in 29 states.

President Obama named Dr. Regina Benjamin as U.S. Surgeon General. Dr. Benjamin, who built and rebuilt a clinic in the bayous of Alabama, is known as a committed advocate for health care as well as a member of the American Medical Association’s board of trustees. While the job of Surgeon General is often largely symbolic, some previous SGs have used the position as an effective platform to push for important health issues such as smoking cessation and testing for HIV.

The dog days of summer, the time when “all creatures become languid,” proved hostile to the debate on health reform, which was characterized more by the stridency of the town hall exchanges than for the clarity of the arguments. Among the major issues that were batted back and forth: whether “advanced directives” implied euthanasia; whether the public option was essential or something to be bargained away in the negotiation process; and whether health coops could replace the public option, achieving some of the same ends without raising as many hackles. In addition, the fact that the President had made major concessions to the pharmaceutical industry – agreeing to forego both leveraging the power of government to bargain for lower drug prices and importing drugs from Canada in exchange for PhRMA’s acquiescence – rankled key members of his own party, who felt that these concessions were premature at best, plain wrong at worst. For the most part, the only option that Public Citizen supports – a Medicare-for-all single payer health insurance system – was kept out of the debate.

The president’s September speech on health care was variously described as a “game changer” by his supporters, but was ineffectual in winning over those opposed to health reform. The immediate audience reflected the existing partisan divide, with cheering and clapping on the part of Democrats and long faces, sour miens, and protests (as well as one memorable heckler) on the part of Republicans.

The data on the number of the uninsured for 2008 showed a rise from the previous year, the result of rising unemployment and a contraction in the number of employers offering coverage. Although there is a rule-of thumb that a rise of one percent in the unemployment rate will lead to a commensurate increase in the rise of uninsured, the full impact of job losses was temporarily blunted by an increase in Medicaid and SCHIP beneficiaries.

In September, the FDA admitted that ‘undue influence’ on the part of four New Jersey Congressman and former FDA commissioner Andrew von Eschenbach had led to the approval of ReGen’s Menaflex, a knee implant to treat meniscus tears. The device was not approved by agency scientists, who were over-ruled in the final decision. The agency is therefore reopening the matter and reassessing the device.

A Dutch and a Danish study both found that Yasmin, an oral contraceptive widely used in the U.S., and oral contraceptives containing the progestin desogestrel are both more likely than other, older pills to cause blood clot injury. In many women, this can lead to pulmonary embolisms, wherein blood clots can travel from the legs to the lungs. Drospirenone, a type of progestin, was implicated in the higher risk found with Yasmin.

After appearing to agree to a number of concessions on health reform (e.g., no exclusions for pre-existing conditions, no rescissions), America’s Health Insurance Plan (AHIP), the lobbyist for the health insurance industry, commissioned a report which concluded that the reform would significantly drive up insurance premiums. The costs estimated by PricewaterhouseCoopers for AHIP were premised on the proposed mandate being ineffectual in attracting younger, healthier populations into the insurance pool. The estimates also assumed that taxes on higher-end plans and other health care sectors would be passed on to consumers, thereby raising the price tag on coverage, and that cuts to Medicare would result in fee increases for other patients. While health economists and policy analysts questioned the accuracy of these assumptions, the report added yet another weapon to the arsenal of scare tactics that have been mustered in the U.S. health debate. Furthermore, the report dashed the Obama administration’s hopes of achieving some sort of accommodation with private insurers, and intensified the debate on having a public option competing with the health insurance companies.

By mid-October, Congressional committees had produced no fewer than five different bills on health reform. All except one included a public option. The attempt on the part of the Democrats to come up with a single bill was hamstrung by the fact that everyone seemed to object to at least part of whatever was proposed. Olympia Snowe emerged as the only Republican willing to incur the wrath of her party in exchange for some type of reform, and she was duly wooed and courted by the Democrats as well as shunned and vilified by her own party.

In a shift from its previous policy and messages, the American Cancer Society adopted a more conservative stance in its advocacy of screening for certain types of cancer. The ACS stated that the advantages of screening had been overstated, especially in the case of breast and prostate cancers, and that screening had led to an over diagnosis of those cancers that did not benefit from early treatment.

After years of downplaying the problem, or even recognizing its existence, the Accreditation Council for Continuing Medical Education (ACCME) took stronger measures to avoid conflicts of interest resulting from the fact that many of the continuing education courses under their aegis are sponsored by drug companies that predictably shape the message to promote their products. The chief executive of the ACCME completed action on 12 inquiries concerning commercial bias in 2008-2009, and had found only five that were violating the rules. While there is growing consensus on the part of different stakeholders that continuing medical education should be free of industry influence, there is less agreement on what this means for industry funding.

On October 24, President Obama declared the H1N1 outbreak a national emergency. While this did not alter the preparations already in place, it gave states greater flexibility in taking measures to arrest the epidemic and treat those affected. The announcement coincided with the realization that the supply of much-promised H1N1 flu vaccine was going to fall significantly below initial projections, the planned 160 million doses that were promised in July dwindling to a mere 28 million by Halloween. The shortfall was due to snags at different steps in the production process, from the virus not growing as fast as expected in the eggs that culture the vaccine, to difficulties in putting the vaccine into vials and syringes.

On November 9, 2009, the Hose of Representatives voted 220 to 215 to approve health reform legislation. The 1990-page bill was complicated enough to have something to please and to concern practically everyone. But it did extend health care coverage (though not to everyone), altered some of the rules under which health insurers operate, strengthened primary care, and made a number of tax changes designed to raise revenues. Part of the price of securing the vote on the broader bill was allowing a vote on an amendment to prohibit coverage of abortion by any plan that is that is purchased with the help of federal subsidies through newly created insurance exchanges. As this goes to press, the focus of health reform moves to the Senate, where the process of interest-aggregation will be equally complicated.

By mid-November, the CDC had revised the mortality estimated due to H1N1 upward, estimating that 3,900 cases had resulted in deaths in the U.S., a number still lower than the usual number of deaths from flu at this time of year.

In a major change from previously-recommended established practice, the U.S. Task Force on Prevention issued new guidelines for breast cancer screening. The new recommendations raise the recommended age for screening for women from 40 to 50 and the frequency of screening from annual to every two years until age 74. In addition, the Task Force is no longer endorsing breast self-examinations. These changes have caused much debate and controversy among different professional and advocacy organizations, with not all of them falling in line with the new guidelines.