New rules promulgated last November obligate Medicare to pay for expensive cancer drugs in hundreds of situations where the drugs are not approved by the FDA.

Medicare now covers Eli Lilly’s Gemzar for 16 different cancers for example. The FDA approves the $5,000 per month drug for four.

And Genentech’s Avastin, which can cost twice that, will now be covered by Medicare for use in cancers of the ovary, brain and kidney. The FDA has approved no such thing.

The windfall is the result of Medicare’s new plan to delegate coverage decisions to a set of reference guides.  If one guide recommends it, Medicare pays unless another guide specifically says you’ve got to be crazy.

Medicare didn’t seem to mind that scientists it retained to study the guides found they “cited very little of the available evidence,” or that they varied markedly in their recommendations according to Amy Abernethy, a Duke oncologist who headed an investigation on the matter. Abernathy’s report is due out shortly.

And guess what? The editors of the guides have financial ties to Big Pharma!

One guide is produced by the National Comprehensive Cancer Network, for example. The Network routinely retains experts on the dole from drug companies.

Then there’s the American Hospital Formulary guide, compiled by the American Society of Health-System Pharmacists.

Last year, the Society inked a deal with a “Foundation” which  accepts $50,000 application fees in return for assuring the applicant’s favorite oncology drug gets reviewed by the guide within 90 days.

No word on whether applicants get their money back if the guide rejects their proposal. (more…)

In 2001, an additive placed in Washington DC’s water had the unintended effect of leaching lead out of the pipes and into the water supply. The plume didn’t resolve until 2005 and District residents have worried ever since what effect it had on their children.

To address the matter, Dana Best and colleagues from Children’s National Medical Center reviewed 28,000 lead level test results performed at their facility.

They found that among children younger than 16 months of age and hence most vulnerable to lead’s deleterious effects, the percent of tests that exceeded the official threshold for concern (10 micrograms) jumped from 0.5 to 4.8 by the peak of the crisis in late 2001.

By 2004, that fraction had dropped to 1.8%.

Best’s group used that and other data to estimate that in 2003-2004, an incremental 900 children developed dangerously high lead levels as a result of the tainted water supply.

A few extrapolations later, the scientists ventured to guess that these kids lost 2-3 IQ points on average and sustained a slightly increased risk of behavioral problems as a consequence.

The study is in Environmental Science & Technology.

The investigators warn however, that there is no legitimately “safe” level when it comes to lead exposure. Even at levels below 10 micrograms scientists have detected similar reductions in IQ.

That’s why Bruce Lanphear, a lead-poisoning expert at Simon Fraser University told the Washington Post, “we suspect that there are thousands, possibly tens of thousands, of children who have experienced harm as a result of increased lead exposure” in the District.

So is 2-3 IQ points a lot?

Best was optimistic. “With enrichment, with a good school environment, it is likely that the loss will not affect your child in a significant way,” she told the Post (leaving open the question as to whether these things were available to all kids in the District).

Last week the FDA’s Cardiovascular and Renal Drugs Advisory Committee unanimously agreed that Eli Lilly’s clot-buster Effient should be approved for the prevention of thrombosis in several acute coronary syndromes.

The FDA normally follows its panel recommendations, and if so Lilly will at long last have an answer to Plavix, the world’s second leading drug by sales with 2007 revenues in excess of $7 billion.

Plavix is co-marketed by Sanofi-Aventis and Bristol Meyers Squibb. Its patent expires in 2011.

The Committee green-lighted Effient for unstable angina and acute myocardial infarction. It was supposed to vote as well on whether to approve the drug for stent thrombosis prophylaxis, but maybe they had planes to catch. 

The Committee’s decision was driven by results from the TRITON-TIMI study, a head-to-head smackdown between Effient and Plavix in which the former proved superior when it came to reducing death from myocardial infarction.

It was saddled with an annoying tendency to kill people via bleeding complications, though.

To deal with the risk-benefit trade-offs, the Committee members recommended that Effient’s go-live should include label warnings regarding the risk of bleeding, especially in those with a history of stroke or who are scheduled for coronary bypass.

There was also a bit of haggling over the excess cancer cases and deaths observed in Effient-treated patients during TRITON-TIMI, but ultimately the committee decided that was a fluke. 

In TRITON-TIMI, 33 people who received Effient died of cancer whereas only 21 died in the Plavix group.

But “the trial was not designed to answer questions about cancer. The cancers diagnosed in TRITON are probably coincidental,” William Macias, Lilly’s medical director told MedPageToday.

And the committee tended to agree. “I wouldn’t have a problem giving this drug to a family member, said James Udelson, a Committee member and the chief of cardiology at Tufts.

Now that the Big O’s nixed the idea of a car czar and tasked Tim Geithner and Larry Summers to deal with the Big 3 who are asking for boatloads more money as we speak, let’s hope those economic titans understand the entire auto parts industry is about to go pfffft unless it gets bailed out, too. 

The parts suppliers requested federal aid 10 days ago. $25.5 billion was the opening bid made by the Motor & Equipment Manufacturers Association, a trade group representing 400 companies in the sector.

It’s probably just coincidence that the amount is nearly identical to the handouts already received by GM, Chrysler and their flailing finance divisions…so far.

“Without immediate assistance to suppliers, the country will face massive job losses and the eventual breakdown of the entire automotive sector in the United States,” according to an 11-page request from the Association that was obtained by the Wall Street Journal.

Last week GM and Chrysler reported breathtaking declines in domestic vehicle sales for January: GM dropped 49% and Chrysler was off 55%.

In 2008, 40 auto parts suppliers filed for bankruptcy protection. That number is likely to be surpassed this year almost no matter what.

The suppliers propose that $7 billion be used to fund a “quick pay program” allowing the beleaguered auto makers to pay suppliers 10 days after receipt of goods. That’s substantially less than the 45 days or more that has become their norm.

They also want $10.5 billion to guarantee receivables and $8 billion in federal loans.

Failure of key parts suppliers could cripple the industry faster than a rabbit on skates because the Big 3 use just-in-time supplier management systems meaning they have essentially no inventory on hand to feed the assembly line.

Republican Senator Charles Grassley has been all over the medical device industry for years.  Why just a month ago he called out the University of Wisconsin in the Zdeblick-Medtronic debacle.

“I am concerned that Wisconsin’s reporting requirements do not go far enough to fully capture a physician’s potential conflict of interest,” he said a moment after revealing the surgeon had pocketed $19 million, most of it undisclosed from Medtronic, the nation’s largest spinal device producer.

That was quite a performance, but now Grassley is movin’ in for serious carcass. Last week, he and Herb Kohl, who ironically is a cheesehead, reintroduced legislation that would require device makers and Big Pharma to list all financial ties with physicians on a .gov Web site.

The public is clamoring for transparency,” Kohl said of the Physician Payments Sunshine Act.

And other parts of the government are providing precision support for the senators on multiple fronts. 

In 2007 for example, the Justice Department forced knee and hip makers to accept its oversight as a quid pro quo for not looking further into allegations they bribed physicians to use their stuff.

In fact Justice already requires knee and hip makers to disclose all payments to physicians on corporate Web sites and has capped per-day consulting payouts to physicians at a measly $500.

Even some hospital systems are getting into the act. Kaiser Permanente for example does not permit its physicians to accept income from the private sector and requires that device makers compete for contracts on price, perish the thought.

Federal officials said last week that Peanut Corporation of America,  the Georgia firm at ground zero of the salmonella outbreak that has killed 8 and sickened 500 in 43 states and Canada, knowingly distributed  contaminated peanut butter a dozen times in the last 2 years.

According to investigators from the FDA and CDC, company-sponsored tests on outgoing products from the Blakely, Georgia plant were positive for the pathogen 12 times since 2007.

PCA shipped the products anyway, occasionally after receiving a clean report from an independent laboratory.

Food producers don’t have to disclose the results of internal testing, so regulators were clueless until after the pigeons flew the coop, the Washington Post reported.

Until closing the plant and then filing for bankruptcy in the aftermath of the fiasco, PCA sold peanut butter and paste produced at the Blakely plant to companies that make candies, cereal, cookies, crackers, cookies, energy bars, and ice cream.

The FDA and PCA have recalled 2,000 possibly tainted products so far. Peanut butter sold in supermarkets appears to be clean.

Remarkably, until the outbreak the woefully understaffed FDA had never set foot inside the Blakely facility.

State inspectors did visit Blakely last October, right when the tainted products were being made. Alas, they didn’t test for salmonella.

Why, the Post wanted to know?

“We do pull product samples from time to time, but we can only run 4,500 samples in a year, and we have 16,000 food-processing and food-sales stores in the state,” Oscar Garrison, a Georgia consumer protection official answered reassuringly.

Even the Big O was outraged.

“That’s what Sasha eats for lunch,” Obama told Matt Lauer. “Probably 3 times a week. I don’t want to worry about whether she’s going to get sick as a consequence of eating her lunch.”

A decade ago, the US government decided we should switch from analog to digital TV. It was a no-brainer. People would get improved reception and the Feds would rake in $20 billion by selling the analog spectrum to cell phone carriers.

The only problem was wiring 20 million US households that watched the tube the old fashioned way. Many of them rely on TV for news about things like impending floods, severe weather and other life-threatening events.

Low income, elderly and Hispanic viewers were particularly likely to be analog users.

These people needed a converter box which cost $80. Senator Ed Markey reasoned government was going to profit from the transition, so it should pay for the boxes.

He wanted to give consumers two $60 coupons each, which would cost $4 billion. Republicans said what are you crazy and capped the program at $1.5 billion.

Meanwhile, the FCC thought the NTIA was supposed to do consumer education but the NTIA was dead in the water due to laughably frequent leadership changes. It turned out the FCC was supposed to do it.

Now the deadline was approaching and the people wanted their coupons.

Not a problem, the NTIA told Congress in November. “The coupon program has both sufficient funds and system processing capabilities to…distribute…more than 50 million coupons (in time)…and to do so without…a backlog.”

So on January 4 the coupon program ran out of money and millions had no coupons.

And Congress had mandated that the coupons be distributed third class mail which we think involves horses and buggies so it was taking a month to get there anyway.

“Millions of Americans, including those in our most vulnerable communities, would have been left in the dark if the conversion had gone on as planned,” sighed the Big O upon signing a bill postponing implementation for 4 months.

Health care conglomerate Johnson & Johnson reported that its Q4 2008 revenues declined 4.9% to $15.2 billion, and braced investors to expect that 2009 will bring the first revenue drop for the company since 1933.

“Consumers and patients are becoming more frugal,” William Weldon told analysts last week. J&J’s Chief Executive added “there is downward [economic] pressure in lots of areas of health care.”

Until things went so wrong for everyone during Q4, J&J’s diversified product portfolio had served it rather nicely compared with competing organizations that concentrated on pharmaceuticals such as Merck and Pfizer.

In Q3, the company told investors the weakening economy was impacting only women’s health products and sports-medicine product lines, but this time around it expanded the list to include vision care products, diabetes monitors and other products that are often paid for out of pocket.

J&J’s pharmaceuticals unit fared poorly in Q4. There, revenues dropped 11% to $5.7 billion. J&J’s best-seller, the atypical antipsychotic Risperdal, lost patent protection in 2008 precipitating a 67% drop in Q4 revenues to $285 million.

Remicade, the company’s anti-inflammatory drug had sales of $886 million, off 2.4% from the previous year due to competition from Amgen’s Enbrel and Abbott’s Humira.

J&J did manage to post a 14% rise in Q4 profit, as expense reductions and one-time gains offset the revenue shortfall.

The weak stock market might tempt J&J to explore acquisitions in 2009, according to Weldon. “This economic environment creates opportunities we may never see again, so we need to be in a position to go after them,” he told the Wall Street Journal.

Mr. Weldon suggested that health IT and wellness companies were “fertile areas” for J&J.

In January, Russian cyber-militia knocked Kyrgyzstan off the grid for a week using a denial-of-service attack similar to the ones it leveled against Georgia and Estonia last year.

The attack targeted Kyrgyzstan’s 2 largest ISPs which provide over 80% of the nation’s bandwidth, according to Don Jackson SecureWork’s director of threat intelligence.

The cyber-attack overwhelmed key government Web sites and rendered emailing impossible, among other things.

At the time, neither Russian nor US officials would comment on the matter and Kyrgyz officials, ahem, couldn’t be reached for comment.

People wondered why would Russia cyber-bully an impoverished nation of 5.3 million that doesn’t mouth off to Vlad the Impaler or have a gas pipeline coursing through it, but now we have the answer.

Last week Kyrgyz President Kurmanbek Bakiyev announced he’s decided to shutter the US’ last remaining air base in Central Asia, just as the Big O was getting set to fire up the base in support of his plans to deploy 30,000 more troops to Afghanistan.

With Russian President Dmitry Medvedev glowering at his side, Bakiyev claimed the Americans were unwilling to pay more money for the use of Manas Air Base, and that locals were chafing at the military presence, established in 2001 to support the US-led invasion of Afghanistan.

“We have repeatedly raised with the United States the matter of economic compensation for the existence of the base in Kyrgyzstan, but we have not been understood,” he said.

Medvedev didn’t just call off the cyber-dogs though. Nice guy that he is, he agreed to loan the former Soviet Republic $2 billion, cough up $150 million in direct financial aid and write off $180 million in debt, according to the Washington Post.

The US pays Kyrgyzstan $150 million each year, 40% of which amounts to rent for the base.

Last fall, the Milbank Memorial Fund authored a white paper on the status of maternity care in the US.

The report concluded that excessive reliance on high tech gadgetry, monitoring and testing made our country by far the most expensive place on Earth to have a baby, yet we graded out average among developed nations when it came to neonatal and maternal mortality.

Last week NIH investigators reported in Obstetrics & Gynecology that if anything, things are getting worse.
 
Elena Kuklina and colleagues of the National Institute of Child Health and Human Development performed a cross-sectional study of 32 million discharge records from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project.

They found that the rate of severe delivery-related complications increased 26% between 1998-1999 and 2004-2005; from 64% per 1,000 deliveries to 0.81%.

Meanwhile, Caesarean deliveries as a fraction of all deliveries rose during the period from 21.2% to 31.1%.

Roughly 2,760 women died from delivery-related complications during the study period, while 227,333 experienced one or more severe complications.

“During the study period, there was a greater than 20% increase in rates of renal failure, respiratory distress syndrome, shock, and ventilation, a 52% increase in rates of pulmonary embolism, and a 92% increase in rates of blood transfusion,” wrote the authors.

The findings could not be explained by differences in maternal age, multiple births (including Octomoms), pre-existing conditions or insurance status.

Increased utilization of C-sections “seemed to explain the observed change over time for renal failure, respiratory distress syndrome, and ventilation,” they wrote.

But that explained only half the rise in blood transfusions, shock and pulmonary embolism, according to the authors. As for the rest of it, who knows?