By Gardner Harris
New York Times.com

Nine dissident scientists at the Food and Drug Administration who say they were forced to approve high-risk medical devices sent a letter to President Obama on Monday stating that agency officials might have made them the targets of a criminal investigation into their complaints.

“It has been brought to our attention that F.D.A. management may have just recently ordered the F.D.A. Office of Criminal Investigations (O.C.I.) to investigate us rather than the managers who have engaged in wrongdoing!” states the letter…”It is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress.”

…The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective…Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one…

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By: British Broadcasting Company News Online

Stem-cell transplants may control and even reverse multiple sclerosis symptoms if done early enough, a small study has suggested. Not one of 21 adults with relapsing-remitting MS who had stem cells transplanted from their own bone marrow deteriorated over three years. And 81% improved by at least one point on a scale of neurological disability, The Lancet Neurology reported. Further tests are now planned, and a UK expert called the work “encouraging”.

It is not the first time this treatment – known as autologous non-myeloablative haemopoietic stem-cell transplantation – has been tried in people with MS, but there has not been a great deal of success…

Stem cells were harvested from the patients and frozen while drugs were given to remove the immune cells or lymphocytes causing the damage. The stem cells were then transplanted back to replenish the immune system – effectively resetting it. Five patients in the study relapsed, but went into remission after receiving other therapy…

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By Aaron Pressman
BusinessWeek.com

As Barack Obama closed in on the Presidency last year, investors got increasingly skittish…Obama’s health-care reform plan is likely to include letting Medicare negotiate lower drug prices, overturning a ban on government-driven discounts that was in the original 2003 “Part D” program.

But Medicare pricing is only part of the story for drugmakers…Investors may be overlooking substantial benefits to pharmaceutical companies because Obama is also likely to get the Food & Drug Administration moving again…The FDA has been widely criticized for weak oversight and inefficiency, and its congressional overseers have had a testy relationship with the agency…

Heath-care reform is also likely to improve prospects for generic drugmakers. With patents on drugs representing $25 billion in annual sales set to expire by 2012, the generic industry is already sitting pretty. The new Congress is planning to revisit the question of allowing generic versions of biologic drugs (those developed from living cells rather than chemical components, which is currently illegal)…

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By Alan Schwarz
New York Times.com

Brain damage commonly associated with boxers has been found in a sixth deceased former N.F.L. player age 50 or younger, further stoking the debate between many doctors and the league over the significance of such findings.

Doctors at Boston University’s School of Medicine found a condition called chronic traumatic encephalopathy in the brain of Tom McHale, an N.F.L. lineman from 1987 to 1995 who died in May at age 45. Known as C.T.E., the progressive condition results from repetitive head trauma and can bring on dementia in someone in their 40s or 50s…

“This is a medically significant finding,” said Dr. Daniel P. Perl, the director of neuropathology at the Mt. Sinai School of Medicine in New York, who is not affiliated with the Boston University group. “I think with a sixth case identified, out of six, for a condition that is incredibly rare in the general population, there is more than enough evidence that football is clearly strongly related to the presence of this pathology.”

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By Julia Medew
Sydney (Australia) Morning Herald.com

…Alex Wodak, a physician who has worked on HIV since it was identified in the 1980s, has called for parents to be educated about the benefits of circumcision after research showed it reduced the likelihood of transmission between heterosexuals in Africa.

“This is an intervention which is effective, inexpensive, lifelong, safe and could dramatically alter the course of an epidemic,” said Dr Wodak, who is also director of the Alcohol and Drug Service at St Vincent’s Hospital in Sydney. “It’s been estimated by mathematical modelling that if the whole of Africa had high levels of male circumcision at the start of the AIDS epidemic, there would have been 5.7 million fewer cases of HIV alone.”

Although circumcision has become unfashionable and even considered child abuse in some circles, Dr Wodak said government departments and health professionals should encourage the circumcision of infant males in Australia as the number of heterosexual transmissions of HIV had increased in recent years.

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By Barbara L. Brush, Julie Sochalski and Anne M. Berger
HealthAffairs.org

Within the first two decades of the twenty-first century, the U.S. population is projected to grow at least 18 percent, and the population age sixty-five and older will increase at three times that rate. Meeting the demand for registered nurses (RNs) that an aging population will require will be a challenge. The U.S. Department of Health and Human Services (HHS) estimated that the United States was weathering a shortfall of 111,000 full-time-equivalent (FTE) RNs in 2000 and projected that this figure will grow to 275,000 by 2010. That imbalance will nearly triple in the subsequent decade, reaching a shortfall of 800,000 FTE RNs by 2020.

U.S. health care facilities, which confront the nursing shortage twenty-four hours a day, are adopting a host of strategies to attract nurses to fill current nursing vacancies and to stave off future shortfalls. Among these strategies is the recruitment and employment of foreign nurses. This is not a new phenomenon, (but)…today, however, (there) is the marked expansion of organized international nurse recruitment; the growth of private, for-profit agencies to do this work; and an increasing number of countries sending nurses abroad. Many of these countries are poorly positioned to surrender large numbers of qualified nursing staff. The consequences for these sending countries have become the focal point of growing international debate that is rising to the highest policy-making levels, although with little resolution…

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By Kevin Sack and Kaite Zezma
New York Times.com

Medicaid rolls are surging, by unprecedented rates in some states, as the recession tightens its grip on the economy and Americans lose their employer-sponsored health coverage along with their jobs.

In a number of states, Medicaid populations grew by 5 percent to 10 percent in the last 12 months and, in many, the growth rate was at least double what it had been in the previous year. State Medicaid officials also say that because enrollment often lags behind job losses by several months, the growth in 2008 may represent only the leading edge of heightened demand.

…In a nationwide survey, with 40 states responding, The New York Times found that in some cases the surge in enrollment had overwhelmed social services agencies, and prompted state fiscal analysts to shred estimates that were often only six months old…

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By Brandon Keim
Wired.com/Science

…In a study of three decades of health data from 51 U.S. cities, researchers found that people are living about three years longer than they did before. Controlling for changes in income, education, demographics and smoking, about five months of that can be chalked up to air improvements.

“Our efforts in the past 20 years to reduce air pollution through better technology and regulation have actually worked,” said Majid Ezzati, an international health expert at the Harvard School of Public Health. “People are living longer as a result of it.”

Ezzati declined to speculate on whether the Bush administration’s approach to air pollution, criticized as being lax and industry-friendly, would reverse some of these gains…

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By Ezra Klein
InThesetimes.com

…(Q:)…Why don’t we begin with each of you giving us the “elevator pitch” of what your groups are advocating for?

Steffie Woolhandler (Co-Director, Physicians for a National Health Program): Our group of more than 15,000 physicians supports single-payer national healthcare insurance. We support that because it’s the only way to affordably cover all Americans. That’s because single-payer allows you to generate huge administrative savings by going to a more simplified payment structure.

If you don’t go with single-payer and you continue with the current system of multiple-payers and the participation of private insurance, you continue to have tremendous administrative waste. And then the only way to get more coverage is to spend more money, and that quickly becomes economically unfeasible.

Richard Kirsch (National Campaign Manager, Health Care for America Now): Health Care for America Now’s goal is to have a guarantee of quality, affordable healthcare for everyone in the nation. And we’ve come together as a coalition that includes 480 organizations that represent community groups, labor, healthcare providers and faith-based groups, among a whole variety of organizations on a common set of principles: That everyone should be covered. That the coverage should be affordable based on people’s income. That the benefits should meet people’s needs. That the coverage should be affordable to employers. And that, in order to do this, we need to have really strict regulation of the private health insurance industry, so that it can’t continue to have a business model that drops people when they need healthcare.

We also need to give people a choice of healthcare coverage. So, in addition to keeping their own healthcare coverage, they have the choice of a public health insurance plan. Private insurance isn’t the only choice. The primary goal is to look at healthcare as a public good.

The reason healthcare in this country costs so much more than in any other country is because we’re the only country that treats healthcare as a commodity.

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By Claudia Kalb
Newsweek.com

The warfare over vaccines and autism is heating up yet again. This week, Alison Singer, the executive vice president of communications and awareness at Autism Speaks, one of the nation’s leading autism advocacy groups, announced her resignation, citing a difference of opinion over the organization’s policy on vaccine research.

“Dozens of credible scientific studies have exonerated vaccines as a cause of autism,” she wrote in a statement. “I believe we must devote limited funding to more promising avenues of autism research.” Singer, who has an 11-year-old daughter with autism, joined the organization when it launched in 2005. Singer praised Autism Speaks and its founders, Bob and Suzanne Wright, but said she could no longer work for a group that supports spending limited resources on vaccine research.

Calling Singer’s resignation “disappointing and sad,” Bob Wright says more authoritative research needs to be conducted on the safety of vaccines given to children under 2. “We all know that autism has genetic causes, but it’s highly associated with environmental factors we can’t get our hands around,” says Wright. “Vaccines fall into that category.”

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