In 2001, Foundation Coal Holdings Inc. and Peabody Energy Corp. asked retired surgeon Derrell Crowder to help reduce their health care expenditures.

Crowder set out to negotiate price reductions with local providers in Wyoming, where most employees lived. He figured the providers would listen to a pitch from two companies that employed nearly 20% of the population in their towns.

The providers blew him off. They thought they had a monopoly on medical services in the area.

Crowder was unfazed. “Even if I got a discount” he told Bloomberg, “Bad care at a discount is still bad care and it’ll be more expensive in the long run” due to costs associated with avoidable complications, unnecessary tests and longer hospital stays.

Crowder then prepared a list of the top hospitals based on national quality indicators and determined how they stacked up on costs. He found among other things that the Mayo Clinic received very high quality ratings and charged approximately $67,000 for coronary bypass surgery, whereas the coal companies’ local hospital received low ratings and charged $98,000 for the same.

Now mine workers at the two companies can choose to undergo certain elective procedures at a national center of excellence. Their employers pay all travel and lodging costs, and reduce co-payments as well.

In the 3 years since the mining companies instituted Crowder’s plan, their health care costs have dropped 5% per year. Nationally, corporate spending on health rose 7% per year during the same period.

No one knows whether cell phones cause brain cancer, and it may be awhile before anyone does.

Many had hoped the Interphone Study would answer the question. Interphone enrolled 14,000 people from 13 countries. It began in 2000, involved 50 scientists and cost $30 million.

Unfortunately, Interphone scientists are now struggling to interpret its data, which has been badly compromised by flaws in study design. The acrimony has pushed back the release date for the final paper from this month to next year.

It hasn’t helped that some Interphone scientists have already published preliminary studies that are based on samples of the Interphone data. Some of these studies contain bizarre conclusions such as a protective effect against certain brain cancers for mobile cell phone users.

The study design flaws are gaping. For example “regular mobile-phone use” was defined to include people who use a phone once each week as well as heavy users. This assures that any moderate adverse effect of regular mobile phone use will be masked.  As well, its retrospective design forces participants to recall specifics of their cell phone 10 years earlier. Do you recall how much you used your phone in 1998?

It remains to be seen whether the data scrubbers can make sense of it all. Meanwhile in the absence of clarity, Interphone scientists have staked out every conceivable position on the matter.

Tainted milk produced in China has sickened 53,000 children and tarnished the nation’s reputation as a food exporter. And the scandal isn’t going away soon.

Toxic melamine, a nitrogen-rich product used to make plastics and by scoundrels to drive up apparent protein concentrations in watered-down milk, has now been detected in yogurt, cake and sweets. Several countries in Africa and Asia have banned diary imports from China after receiving shipments of affected milk. European chocolate-maker Cadbury recalled its China-produced products as well.

A month ago, China’s government did an abrupt about-face on the matter. In the run-up to the Olympics, government-controlled Internet portals squelched stories about the scandal. After the Olympics, the government made a showy effort to get out front. It detained the chairwoman of Sanlu, one of the dairy concerns at the heart of the scandal.  It arrested some milk distributers and detained others. The mayor and local Communist Party leader of Sanlu’s home city have resigned, as has the head of China’s national quality control bureau.

It’s unlikely these steps will fix China’s food-processing systems. Local party leaders are responsible for quality control, and many enjoy cozy relations with food producers.

Foreign companies have known the Chinese system was suspect. Unilever ended joint ventures with local producers years ago. McDonald’s developed a closed supply chain for its signature offerings, and Coca-Cola monitors suppliers with enormous vigor.

Emergent BioSolutions of Rockville, Maryland has been the government’s only provider of anthrax vaccine ever since it secured a half billion dollar sole source deal several years ago to stockpile 19 million doses of its version, known as BioThrax.

BioThrax has limitations though. It must be refrigerated for example. Inoculated conscripts have reported serious complications, and 6 injections over 18 months are needed to produce a sufficient immune response.

The US government has thus just awarded development contracts to two companies, Emergent and its rival PharmAthene, to create improved vaccines.

Emergent Biosystems secured $29.7 million to develop an improved version of BioThrax that will require fewer injections. It will still require refrigeration, however.

The government’s decision was a coup for PharmAthene. It received $83.9 million to create a vaccine that requires only 1 or 2 injections and can be stored at room temperature.

The split decision heightens anticipation for the announcement later this fall of the big prize, a contract (or contracts) to supply 25 million doses of recombinant (genetically engineered) anthrax vaccine to the US Strategic National Stockpile. 

The agency that awarded the two contracts is the Biomedical Advanced Research and Development Authority (BARDA). It sits within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. According to the HHS web site, BARDA’s mission is “to provide an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.”

Few companies are benefiting from the financial crisis, but business networking sites such as LinkedIn and Xing are doing just that. These sites have grown rapidly as economic conditions have soured. In the last several weeks, an unprecedented number of LinkedIn members updated their profiles, preparing themselves perhaps for the possibility they may lose their jobs.

LinkedIn and Xing provide platforms allowing business professionals to get their names out there, keep track of peers and industry leaders, establish new contacts and form groups with common interests.

LinkedIn is a privately held, Silicon Valley based company that has 29 million members. It was started in 2002 and is now valued at $1 billion on revenues of approximately $100m. LinkedIn’s revenues derive from members as well as headhunters and companies that pay to troll their databases.

Xing is a German company that has 6 million members. It was founded in 2003 and went public in 2006. It had revenues $24m in the first half of this year. Xing’s revenues derive primarily from subscription fees, because the site emphasizes networking rather than job search.

Their business concept now proven, these two companies now must fend off competition. Facebook has the capacity to play in this space, for example. Even the venerable Wall Street Journal and New York Times have nascent professional networking features on their sites.

America hasn’t had landed a man on the moon in 36years and it has no immediate plans to return there. Meanwhile, China can now boast it has the moon in its sights.

This after three Chinese astronauts parachuted to Earth yesterday following an error-free mission which included China’s first spacewalk. Crowds gathered before outdoor TV monitors across China to cheer the spectacle.

China’s leaders are riding a wave of nationalism following the Olympics. There is no public opposition to their space program, and they face few of the budgetary constraints that have plagued NASA for decades.

China plans to construct a space station within 5-10 years and land an unmanned probe on the moon shortly after that. It is a matter of time before China announces plans to put a man on the moon.

China’s latest space success created less angst in the US than its last one, in which it blew up a failed weather satellite with an anti-satellite missile some 21 months ago. China’s space program is run by the military, but China insists its program is peaceful.

With many nations’ economies in tatters, those who are still inspired by human space exploration will be gazing up at red flags for the foreseeable future.

Medtronic’s spinal devices unit has been in bunker mode since the FDA alerted surgeons about serious complications associated with off-label use of its products. Yesterday, the medical device giant received more bad news when sealed documents from a 2002 lawsuit were leaked to the Wall Street Journal.

The suit was filed by a former Medtronic lawyer. It alleges that the spinal devices unit provided surgeons incentives to use its products. The incentives included entertainment at a Memphis strip club, fishing expeditions to Alaska, free rides on Mardi Gras parade floats and royalties on inventions they didn’t develop.

The federal government does not allow companies to provide incentives that encourage physicians to use products covered by Medicare and Medicaid.

The spinal devices unit is already under investigation by Sen. Charles Grassley (R-IA) who wants to know whether incentives like the ones alleged in this lawsuit have driven widespread off-label use of Infuse, a growth factor that promotes healing following lower back surgery. Medtronic had refused to provide documents from the case to Sen. Grassley’s staff.

Medtronic denies engaging in improper behavior of any kind and added that it is “committed to reform and transparency in the industry.”

Britain’s National Institute for Health and Clinical Excellence (NICE) new treatment guidelines for attention-deficit hyperactivity disorder (ADHD) suggest that drugs should be used as first line therapy only for those who are severely impaired.

British physicians are strongly encouraged to implement the NICE recommendations, but they are not obligated to do so. Widespread adoption of the new guidelines would result in dramatic reductions in the use of Ritalin (Novartis) Concerta (Johnson & Johnson) and Strattera (Eli Lilly).

The NICE recommendations call for group-based parent education and training programs as the first line intervention for children with mild or moderate impairment due to ADHD. These behavioral/social interventions are also recommended, along with drug therapy, for severe cases.

NICE also stated that primary care physicians should neither diagnose ADHD nor start drug treatment on their own. These decisions should be left with psychiatrists, pediatricians or those having expertise in ADHD.

Approximately 3% of all school aged children are thought to have ADHD, but only a small percentage of them are severely impaired. In the US, more than 2.5 million children take drugs for ADHD.

Digg Inc., a social-networking site where users share their favorite content from anywhere on the web, plans to double its staff to 150 in the next year, expand into international markets and move into spiffy new, uh, digs.

A $28.7 million investment led by Highland Capital partners of Lexington, Massachusetts will fund the expansion. As part of the fresh funding, Highland’s Richard de Silva will sit on Digg’s board.

Digg was founded in 2004 and now claims to have 30 million visitors to its site each month, twice as many as one year ago. Its expansion comes at a time when traditional media companies are struggling as readership and advertising revenues shift to the Internet.

At the time of this post, the three most popular items on Digg were:  You liberals could put a negative spin on anything (a comment exchange from Flickr), Craig Ferguson on McCain suspending his campaign (a YouTube video), and Listen to yourself (a web comic).

Couric Grills Palin on Foreign Policy

In July, the American Academy of Pediatrics (AAP) updated its guidelines for managing high cholesterol in children. The revisions generated a blizzard of media attention that surprised many in the pediatrics community.

After all, the revisions were for the most part incremental compared with previous iterations: slightly more comprehensive screening, an emphasis on the quality of fat intake rather than total fat intake, and a reduction in the recommended age for initiating drug therapy from 10 to 8 years.

There was one thing though, that was not incremental. The AAP now recommends statins as potential first-line cholesterol-lowering drugs for kids in whom efforts to lose weight and exercise fail to sufficiently reduce high cholesterol level. The older version made no mention of statins and recommended bile acid-binding drugs instead.

The bile acid binders don’t work well and are poorly tolerated. Statins work exceedingly well and are well tolerated in adults. The problem is that there is only limited, short-term data showing statins are safe in kids. In selecting a drug to recommend, the AAP had to trade-off unknown long-term risks of statins vs. their clear superiority as cholesterol lowering agents.

Sales of statins are already in the billions and how exactly can we subject our kids to unknown risks like that? The reasons for the firestorm are clear.

Now, two Harvard clinicians have posited that the epidemic of childhood obesity is the larger contextual issue at work here. That is what drives unprecedented numbers of kids to the point where they need cholesterol-lowering drugs in the first place. And that is what forces pediatricians to use other powerful “adult” drugs like diuretics and beta blockers for high blood pressure, insulin sensitizers for metabolic syndrome, and even aspirin for coagulopathies that these kids end up with in addition to high cholesterol. We don’t know much about how these drugs work in kids, either.

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Nearly 60% of the clinical trials that the FDA reviewed during its approval processes for new drugs between 1998 and 2000 were not published in peer reviewed journals within 5 years after the drugs went to market, according to research published in PLoS Medicine. 

24% of the non-published studies were “pivotal” trials focusing on safety and effectiveness in humans. Within this cohort, the PLoS study revealed publication bias: trials showing significant benefits for a new drug were more likely to be published than those showing no benefit.

Pharmaceutical companies sponsor the studies in question and they get to decide whether to pursue publication of trial results or squelch them.

PLoS study investigators concluded that Big Pharma’s failure to publish the results of all trials amounted to “scientific misconduct” that “harms the public good” because it prevents physicians from making informed decisions on behalf of their patients.

Things may be about to change at least a little however. The 2007 FDA Amendments Act mandated that substantial detail from all trials used in support an FDA approval process must be posted on the NIH clinical trials site. This is a good step, but maybe not enough. Clinicians may or may not recognize the unique value of the newly informed NIH site, much less use it. And it doesn’t address the problem with publication bias at all.

Previous Worst Time Out in History

It’s yesterday morning. The Big O’s peeps call their Republican counterparts to suggest releasing a joint statement on the financial crisis. The Republicans agree. For six hours there’s no contact, and then look! It’s Top Gun on the tube! He’s suspending his campaign and stepping out to help solve the financial crisis.

Thank heavens! Washington needs his vast economic expertise right now.

McCain also says he wants to suspend Friday’s debate. A time out in the middle of a presidential campaign? Technical foul!

Here is how the Big O responded: “It is my belief that this is exactly the time when the American people need to hear from the person who, in approximately 40 days, will be responsible for dealing with this mess. It is going to be part of the president’s job to deal with more than one thing at once.”

Thanks to an acclaimed state initiative, 439,000 more Massachusetts residents have health insurance now than in 2006. Ironically however, many of them cannot find a doctor.

Massachusetts didn’t have enough primary care doctors to begin with, but the flood of newly insured people means that Bay Staters have to wait as long as 100 days to see a PCP. Those who have urgent problems or who are OK seeing a nurse practitioner can get seen sooner, but others have resorted to ER visits, which is what they did before they obtained insurance in the first place.

Legislators have approved many new laws to alleviate the problem. One allows UMass Medical School students to waive tuition in return for a promise to work as a PCP in the state for four years. The state has also agreed to repay medical school loans for PCPs who work in underserved areas for two years. Inexpensive housing loans are also available for PCPs in the state.

Unfortunately, these “initiatives have a long lag time,” says Bruce Auerbach, President of the Massachusetts Medical Society. Auerbach believes that increased payment and reduced administrative burdens would more effectively address the state’s PCP shortage.

In a move lauded by advocates as a major step in the country’s understanding of mental health, the House and Senate approved bills yesterday requiring private insurers to provide mental health benefits equivalent to those for physical illness.

Currently, private insurers can limit mental health coverage to 30 doctor visits and 30 hospital days per year. The new law prohibits insurers from setting such limits if they don’t set limits for medical conditions like heart disease.

The house version of the bill was sponsored by Jim Ramstad (R-Minn), a recovering alcoholic, and Patrick Kennedy (D-RI), who has faced drug and alcohol problems.

The bill has bipartisan support in Congress. It is backed by the medical community, insurance companies, the private sector and the White House.

Still, it’s not clear the bill will become law. The House and Senate versions differ in their financing mechanisms. As well, the House version is a standalone bill, while the Senate rolled the legislation into a bill that includes $150 billion in tax cuts. Congress adjourns in a few days.

“We’ve come so…far,” noted Andrew Sperling, director of legislative affairs for the National Alliance on Mental Illness. “We are in a…world of trouble if we don’t get this done (now).”

The EPA will not to set safety standards for perchlorate in drinking water after all. White House and Pentagon officials have pressured the EPA for years to refrain from establishing safe allowable levels of the chemical. Recently, these officials deleted sections of a report by EPA scientists that underscored the dangers of perchlorate and advocated for its regulation.

The report estimates that 16 million Americans are exposed to unsafe levels of the chemical. Independent scientists using state and federal data suggest the number is twice as high.

Perchlorate is a rocket fuel additive that causes thyroid abnormalities in newborns and children. Redacted from the EPA report were results from research by UMass professor Robert Zoeller, who found that even tiny amounts of perchlorate can impair thyroid hormone production. This can cause irreversible loss of IQ and increased perception and behavioral problems in children.

Nearly all perchlorate in drinking water results from lax disposal methods at chemical plants, rocket test sites and military installations. A national cleanup would cost several hundred million dollars.

The Bush administration has “distorted the science,” Zoeller said. “Infants and children will continue to be damaged, and that damage is significant.”