Archive for October, 2008

Panel Calls Out the FDA on BPA

October 31st, 2008 | No Comments | Source: Washington Post

A scientific advisory panel has determined that the Food and Drug Administration used flawed methods and ignored key facts in deciding that a chemical used to harden plastic in baby bottles is safe.

The panel included academic and government scientists. Its critique lambasted the regulatory agency for examining an insufficient number of baby formula samples in its study of bisphenol A (BPA) and focusing solely on mean BPA values without regard for the fact that some samples had very high BPA values.

The report also cites the FDA for failure to mention animal studies which have shown links between BPA and diabetes, prostate cancer and other medical conditions, as well as National Toxicology Program studies that suggest BPA might adversely affect brain development in infants.

Because the FDA did not account for such findings, it ended up recommending a “safe level” of BPA that may not be safe at all, the report concluded.

An FDA spokesperson seemed to accept some aspects of the critique. The “FDA agrees that due to the uncertainties raised in some studies relating to the potential effects of low doses of bisphenol-A that additional research would be valuable,” Judy Leon told the Washington Post.

The FDA has begun to carry out additional research on the matter. Meanwhile, John D. Dingell (D-Mich.), Chairman of the House Committee on Energy and Commerce, his colleague Rep. Bart Stupak (D-Mich.) and the attorneys general in several states are on record saying the bottle makers ought to just get rid of the stuff right now.

Canada recently enacted such a ban, and some retailers now sell BPA-free formula bottles in response to consumer outcries. The trade group representing BPA manufacturers has indicated its constituents will comply with FDA regulations once they are promulgated.



Having it Their Way

October 31st, 2008 | No Comments | Source: Economist

For 20 years Burger King left China’s exploding fast food market to McDonald’s and Yum! Brands, which operates Pizza Hut and KFC. Burger King joined its rivals on the mainland in 2005, but as recently as this April, it had only 12 storefronts in China.

Now, the King wants in on China’s $29 billion fast-food market and who can blame them?

This summer Burger King announced plans to open 300 outlets in China over the next 5 years. That still places it a distant third behind KFC, with 2,200 outlets and McDonald’s with 1,000.

And there’s a lot of work to do. For example, Burger King must get up to speed on Chinese food preferences. Chinese consumers it turns out, prefer chicken over beef-which is more or less what’s inside its trademark Whopper (known locally as huangbao, or Emperor Burger).

Burger King can thank its larger rival for some pioneering work in this regard. McDonald’s spent a ton of Yuan over the last decade convincing Chinese consumers that there are health benefits associated with eating beef (we promise to reveal these benefits once we learn what they are).

Even after tweaking its menu, the King knows it needs a killer strategy to make up for lost time. Right now its plan is to target younger, independent-minded consumers that want to distinguish themselves from older family members who prefer the “traditional offerings” served at Micky-D’s and KFC.

Hmmm…that might work, but a Cantonese version of “hold the pickles hold the lettuce, we don’t let special orders upset us,” wouldn’t be a bad backup.


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Wyeth v. Levine Set for Next Week

October 31st, 2008 | No Comments | Source: Wall Street Journal

Several years ago, Vermont guitarist Diana Levine lost her arm and her livelihood to gangrene after a health care provider administered a nausea drug improperly. Levine argued in state court that drug maker Wyeth should have affixed stronger warnings to the nausea drug’s label. A jury awarded her $7 million in damages.

The US Supreme Court hears the appeal next week. Wyeth will argue that the Food and Drug Administration had approved the drug label and that decisions by federal regulators like the FDA should supersede state law on the matter of product safety. 

 “This case is worth tens of billions to the pharmaceutical industry,” Ms. Levine’s lawyer Richard Rubin told the Wall Street Journal.

The 2008 model of the Supreme Court is among the most pro-business in generations. Even Steven Breyer is on record as strongly supporting FDA primacy in similar situations.

But consumer advocates have reminded the Court that the FDA doesn’t always get things right when it comes to product safety. According to these groups, recent settlements against Eli Lilly (Zyprexa), Merck (Vioxx), and Wyeth itself (fen-phen) suggest that a patient’s right to sue-in state court if need be-may be the most effective means to fight against corporate shenanigans.

Wyeth v. Levine has drawn additional interest as a possible precedent for cases outside health care. What happens for example, when states set environmental or fuel efficiency standards that are tougher than those set by federal agencies? The case could also impact future product liability suits covering the gamut from autos to baby cribs.

Anybody got tickets?


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Beth Israel Pulls up its Skirt

October 30th, 2008 | No Comments | Source: Boston Globe

Odds are, the quality of care at Beth Israel Deaconess hospital is roughly the same as that provided at Boston’s other teaching hospitals, which is to say it is excellent.

So why is it that there seems to have been a ton of medical screw-ups at The Deek lately? Almost certainly this has to do with CEO Paul Levy’s bold policy to be forthcoming when medical errors do occur rather than the typical approach in which hospital leaders try mightily to bury these stories.

Credit Levy and his team for true leadership on the matter.

To be sure, it seems like The Deek has been haunted lately. In June, the hospital fired a cosmetic surgeon after he appeared to nod off while performing liposuction. Days later, another surgeon operated on the wrong ankle of a female patient. Earlier this month, a previously terminated drug abusing staff anesthesiologist was found in a hospital closet, dead as a door nail. Cue the ghoulish music.

Medical errors big and small happen with striking regularity at all hospitals. By some counts, 15 million errors occur each year in the US (thankfully few are this egregious, however).

That’s why Levy’s relentlessly transparent approach, if he backs it up with a data-driven, scientifically based, hospital-wide improvement program, may eventually elevate The Deek’s performance to truly outstanding levels.




Yammer Tweaks Twitter

October 30th, 2008 | No Comments | Source: NY Times

Some scoffed when Yammer went live 8 weeks ago. With 3 million people Twittering away, did the world really need another microblogging platform?

No one’s laughing now, and it turns out the 2 companies could not be more different in many important aspects.

Twitter burst onto the scene 2 years ago and almost overnight created a new verb that entrenched itself in modern lexicon to nearly the same degree as “to Google.” “To Twitter,” users simply logon with a computer or cell phone and respond to the question, “what are you doing?”

Responses, or “Tweets” are limited to 140 characters. They range from profound and poetic to decidedly humdrum, like “I should have worn a sweater.” 

But despite Twitter’s enormous popularity and brand recognition, it has zero revenue. Not a cent. Not even from advertisements.

Twitter has argued that YouTube had little revenue when it sold to Google for $1.7 billion, and Facebook has a similar valuation on revenues of only $150 million. “Get the eyes first, worry about revenue later,” is the mantra. “Oh and by the way? Twitter registrations are up 600% this year.”

Which brings us to Yammer, the West Hollywood start-up that tweaked Twitter’s microblogging concept into an internal corporate communication tool and started generating revenue the day it went live.

As with Twitter, anyone can join Yammer for free, but they must have a corporate email account to do so.  Yammer users (Yammerers?) answer a Twitteresque question, “What are you working on” to communicate with company colleagues.  If the company wants to assume administrative control over the chatter, they pay Yammer.

It has been called Twitter with a business model, and it was enough for Yammer to secure the prestigious TechCrunch 50 prize last month. Yammer claimed that 10,000 people and 2,000 organizations signed up for the service the day it launched.



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Collateral Damage in Iceland

October 30th, 2008 | No Comments | Source: Economist

What can the financial collapse in Iceland teach us about health care start-ups close to home? Plenty, it turns out.

The north-Atlantic island nation is home to two innovative health care companies, DeCode Genetics and Actavis, and although they are not to blame, both have been staggered by Iceland’s economic catastrophe.

DeCode Genetics pioneered personal genomics by perfecting DNA-sequencing processes and leveraging its access to Iceland’s unique national genetic database. It made breakthroughs in the last 2 years that leave no doubt it is a player. For example, it identified genes associated with basal cell carcinoma and possibly causative gene mutations for schizophrenia.

DeCode cut its burn rate by half earlier this year to guard against financial hard times, but it wasn’t nearly enough. Like many early-stage biotech companies, DeCode has tiny revenues and large cash flow needs. It is now encountering severe difficulties accessing credit. Worse, Lehman Brothers tied up $30m of DeCode’s reserves in risky US auction-rate securities before it went bust a month ago. There are no buyers for the securities right now.

Actavis, Iceland’s other health care jewel had risen to become the world’s fifth-largest generic drug maker through a series of smart acquisitions. The company had diversified product offerings and built a global distribution system which should have insulated it from financial hard times.

Not so. Actavis’ problem is that Thor Bjorgolfsson, a billionaire who controls the company had a large stake in an Icelandic bank and that money vaporized when the bank was nationalized 3 weeks ago. Now many speculate that Bjorgolfsson will sell Actavis to recoup some cash.

Both companies are likely to survive since they demonstrably create value for shareholders, but not without a good deal of hand wringing, soul searching and tumult. US biotech companies take notice.


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Gates Foundation Gets Jiggy

October 29th, 2008 | No Comments | Source: Washington Post

As part of its Grand Challenges Explorations program, the Bill & Melinda Gates Foundation has awarded 104 grants in the amount of $100,000 to fund some of the wilder ideas to come from medical researchers in years.

How wild are they? Hiroyuki Matsuoka believes mosquitoes can be recruited into flying syringes that deliver vaccines rather than diseases. Nobel Prize winner Andrew Fire thinks it’s possible to fight viral infections by deactivating a single gene, and another researcher wants to develop “stealth weapons” against HIV.

The Gates foundation rarely funds fringe ideas like this, but the concept behind the program is similar to that used by venture capitalists: if one or two of the funded ideas bear fruit, the entire investment may prove worthwhile. 

The 2-page online application did not require lengthy arguments or data to support a hypothesis, only a legitimate way to test it. And the selection process did not involve peer review. That’s because, “peer review-by definition almost excludes innovation because innovation has no peers,” Tadataka Yamada, the Foundation’s Director of Global Health told the Washington Post.

Yamada ought to know. A gastroenterologist by training, he ridiculed a hypothesis put forth by Australian researchers Robin Warren and Barry Marshall that peptic ulcers were caused by bacteria rather than stomach acid. Marshall eventually swallowed a carafe of the bacteria to prove his point, and nearly died from an ulcer before being cured with antibiotics.

The Australian pair won the Nobel Prize a few years later.


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China Reforms Land Ownership Laws

October 29th, 2008 | No Comments | Source: Economist, NY Times

Last Sunday Xinhua, China’s state-run news agency announced that Communist Party leaders approved a historic land reform policy allowing farmers to lease, exchange or transfer land-use rights for the first time.

The major economic reform capped a week of speculation after leaders hinted at breakthroughs in their thinking about rural property rights.

The new policy allows peasants to consolidate small, inefficient plots into larger, more productive combines, monetize their property in other ways and achieve significantly increased income for the first time in decades. It is also likely to increase per capita agricultural output just as domestic demand for food has surged.

Until now, Chinese farmland had been owned collectively. Local party officials could, at their discretion lease land to peasants on 30-year contracts but the land could not be mortgaged, traded or sold. Worse, the local officials often repossessed land for urban expansion projects without compensating the farmers.

The government’s announcement was timed to correspond with the 30th anniversary of China’s last major land reform policy initiated by Deng Xiaoping. Those reforms triggered a brief jump in rural income, but this has stagnated for two decades while urban income has exploded.

The marked rural-urban income discrepancy and the corrupt practices of local officials had triggered hundreds of protests from Chinese farmers as well as a mass exodus into its cities. Despite the migration, more than 700 million Chinese still live in rural areas.



Crazy Good

October 29th, 2008 | No Comments | Source: Harvard Med. Alumni Bull.


People have suspected for at least 2000 years that mental illness is disproportionately common among artists. Aristotle for one believed that great philosophers and artists alike had to endure some form of melancholy. Irving Stone’s Lust for Life, a 1934 tome about Vincent van Gogh’s lifelong struggles with psychosis (and the 1956 film adaptation starring Kirk Douglas and Anthony Quinn) helped popularize the presumed association.

Writing in this month’s Harvard Medical Alumni Bulletin, psychiatrist Richard Kogan explores the link for classical music composers such as Mozart, Beethoven, Schumann and others.

Kogan has particularly interesting anecdotes about the Russian composer, Pyotr Tchaikovsky. Among other things, Tchaikovsky was convinced that his head was about to fall off his neck. He was chronically depressed and expressed suicidal ideation many times in his diary. He self-medicated with alcohol and once confessed, “I’m drunk every evening, and I cannot live otherwise.” (aha! Pizaazz now understands why the man felt his head was about to fall off his neck)

Kogan tells us that composing music did alleviate Tchaikovsky’s suffering. Tchaikovsky’s ballet masterpieces such as Swan Lake, The Nutcracker and Sleeping Beauty are musical fantasylands where, it is said, Tchaikovsky could escape his own despair.

Tchaikovsky also lived in constant fear of being outed as a homosexual, and with good reason. In czarist Russia, this behavior was punishable by banishment to Siberia.


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MD Age, Specialty Impact Care Post-MI

October 28th, 2008 | No Comments | Source: Canadian Med. Assoc. J., MedPageToday

Older physicians and non-cardiologists are less likely to prescribe proven effective medicines for patients that recently sustained a heart attack, according to a study published in this week’s Canadian Medical Association Journal.

Peter Austin and colleagues at the University of Toronto conducted the study. They reviewed administrative data from 132,778 myocardial infarction (heart attack) patients in Ontario between 1992 and 2005.

Overall, the scientists found a heartening rise in utilization of beta-blockers, ACE inhibitors and statins in post-MI patients over the course of the study period. Prescriptions for these medications rose from 42.6%, 42% and 4.2% respectively at the beginning to about 80% for all three groups by 2005.

However, physicians that had practiced medicine for at least 29 years adopted best practices more slowly and in the end were 19% and 29% less likely to prescribe statins and beta-blockers than their younger colleagues.

Similarly, non-cardiologists were 18-54% less likely than cardiologists to discharge patients on these medications.

Medical evidence had established the efficacy of beta blockers by 1992. Final verdicts on ACE inhibitors and statins were nailed down by 1995 and 1998 respectively. In general, these drugs reduce mortality, reduce complications and improve functional status post-MI.



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