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 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 in tap water. 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 a host of 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.”

The Senate Committee on Aging will soon hold a hearing about direct-to-consumer ads for medical devices.

Herb Kohl (D-Wisc), Chairman of the committee, indicated the hearing was necessary to decide whether the FDA ought to ramp up its oversight of device promotions to match what it already does for drug ads. “The medical device industry is just beginning to get into the game,” he said.

DTC advertising for medical devices nearly doubled between 2005 and 2007, to approximately $193 million. This is peanuts compared to the $5 billion spent annually on prescription drug promotions, but some people believe medical device advertising can have a disproportionately large impact on consumers. Surgery is after all usually required to implant medical devices and the devices remain in situ for years.

Currently, TV promos for medical devices are not required to address risks and benefits as are those for pharmaceuticals.

Johnson & Johnson promotes its artificial hips with ads featuring iconic Duke basketball coach Mike Krzyzewski. The ad shows people jumping rope and surfing, among other things. In spots for its competing product, Biomet features former Olympic gold medalist Mary Lou Retton.

When food prices surged this year, experts attributed the run up to increasing demand, higher energy costs and drought. It turns out there may be another explanation as well-rampant price fixing and collusion in the food industry.

Federal prosecutors announced yesterday that they have started separate criminal investigations of large egg producers and California tomato processors to determine whether such activities have occurred. The Feds recently also opened similar price fixing investigations in the dairy, fertilizer and citrus fruit industry.

The price of tomatoes rose 16% this year, nearly three times more than the overall rise in food prices. Domestic egg prices rose by 40% earlier this year after the 3 largest domestic egg producers began exporting small amounts of eggs to the Middle East and Europe.

It will be awhile if ever, before the Feds are ready to make their case. Even now though, analysts are predicting that the food industry will not deny allegations of price fixing but argue instead that their behavior is legal under obscure antitrust exemptions like the Capper-Volstead Act, which was promulgated in 1922 to help small farms negotiate with large food processors.

Conventional wisdom is that the health care sector is recession-proof. That isn’t the case right now.

The number of prescriptions filled has fallen more than 2% in the last year for example, while overall physician office visits declined 1.2% and Ob-Gyn visits declined 6% during the same period. Nearly 22% of individuals responding to a survey by the National Association of Insurance Commissioners indicated that deteriorating family finances have caused them to use fewer health services in the last year.

Among uninsured Americans, drop-offs in health services utilization s are particularly dramatic. Quest Diagnostics, Inc. reports that there has been an 8% decline in lab testing for such people.

But those with health insurance are cutting back as well, probably because out-of-pocket expenses have grown dramatically in recent years. According to the Kaiser Family Foundation, average annual family plan deductibles are nearly $760 for HMOs and $3,600 for high-deductible plans. These figures are twice as high as they were 7 years ago.

Then there’s the cost of gasoline. For some, an 80 mile round trip to get blood sugars checked is simply out of the question even if the visit is covered.

For years, the idea of adapting to climate change has been anathema to environmentalists. Adaptation is admitting defeat or at the least taking the eye off the ball, which is prevention.

Those attitudes may be changing for two reasons. First, climate change is happening a lot faster than most thought it would. According to Manish Bapna of the World Resources institute for example, it is too late to avoid “dangerous consequences, so we must… adapt.”

Second, it’s becoming clear that global warming disproportionately impacts the most destitute people on the planet. The poorest of the poor depend on arid climate agriculture, subsistence fishing and rain forests-things that are directly and immediately affected by climate change.  If any group needed to adapt it is this group, but the very poor cannot afford the irrigation systems, flood control systems and complex public health initiatives necessary to adapt.

Destitute people happen to have minute carbon footprints. The irony of this is not lost on UC Berkeley’s Kirk Smith who reminds us that climate change is “the world’s biggest regressive tax: the poorest pay for the behavior of the rich.”