Health business blog

Health business blog has moved

2006-12-21T21:26:00.000-05:00

The Health business blog has moved to www.healthbusinessblog.com.

Bye bye Blogger! Goodbye Google!

2006-12-21T20:58:00.000-05:00

The Health business blog is moving to www.healthbusinessblog.com. After almost two years and more than 1000 posts, I've also decided to switch from Blogger to WordPress. Blogger served its purpose, but it had a number of maddening problems that I'll be glad to put behind me. So far I have only good things to say about WordPress.

Blogger has just launched a new version of its software, which promises to fix many of the earlier glitches. From what I've seen it still won't match WordPress. In addition, Blogger is being more closely integrated into its corporate parent, Google. Google is an amazing company but I am wary of them. I'd just as soon keep my distance.

If you get the Health business blog via RSS feed and you use the Feedburner feed (http://feeds.feedburner.com/Healthbusinessblog) , you don't need to do anything --your feed will still work. If you use the http://www.mppllc.com/pages/atom.xml feed, please subscribe to the Feedburner feed or use http://www.healthbusinessblog.com/?feed=rss2.

I'll be leaving the old blog up, I just won't be updating it. So if you have linked to any old posts you'll still be able to access them.

If you have any questions or comments about any of this, send me an email: dwilliams@mppllc.com.

Thanks for your readership and I look forward to your visits to the new Health business blog.

The value of private funds for drug research

2006-12-20T13:47:00.000-05:00

Babies with “short bowel syndrome” are fed intravenously to keep them alive. Unfortunately prolonged IV feeding often leads to liver failure. Doctors at Children’s Hospital in Boston haven’t been satisfied with that trade-off and have experimented with a variety of ways to avert liver problems. A particularly promising remedy is to use Omegaven, a fish-oil based formula that’s on the market in Europe (for adults) but not the US.

Omegaven’s maker, Fresenius AG doesn’t want to market Omegaven here. Basically, they’ve decided it’s not in their commercial interest. Instead Fresenius has a new product in development that they’d prefer to bring to market. Meanwhile Fresenius is happy to sell its existing product, Intralipid. That’s tough luck for babies who need treatment now. Fresenius has actively resisted efforts to allow testing of Omegaven, and the FDA hadn’t been too helpful either. The Wall Street Journal wrote an article on the topic (A Doctor’s Push For Drug Pits Him Against Its Maker) a month ago.

Now, according to another Wall Street Journal article (Trial to Test Drug for Sick Babies) the trial is going ahead. The FDA relented and The March of Dimes stepped in with funding. The trial will pit Omegaven against Intralipid. Babies who start on Intralipid will be able to switch to Omegaven if they develop liver damage. Likewise babies starting on Omegaven will be able to switch to Intralipid if they have problems.

Meanwhile Fresenius is getting a free lesson in how not to build a corporate reputation in the US.

Based on what I read in the Journal, I’m going to make a donation to the March of Dimes, and I suggest you consider doing the same. The donation link is here. (MedImmune is matching donations dollar for dollar during December, up to $50,000.)

Henry Ford regulates pharma reps

2006-12-19T20:24:00.000-05:00

The Henry Ford Health System is banning free lunches and gifts by pharmaceutical and medical equipment sales reps, starting January 1, according to the Detroit Free Press. Representatives will also have to schedule appointments with physicians and pay a $100 certification fee to Henry Ford before being allowed to do so.

"The evidence shows that when physicians are exposed to pharmaceutical representatives, their decisions are different," Dr. A. Mark Fendrick, a U-M drug price specialist, told the Detroit Free Press. "It is very unusual to find generic drugs in a physician's sample closet."

The program is portrayed as a way to keep industry in line, but I look at it as part of the maturation of the relationship between pharma and docs. Sales reps buy lunch and provide gifts because doctors want that to happen; many expect it as a kind of entitlement. It's just as well to have that practice end. I'd suggest Henry Ford use that $100/rep tax to fund an education program for physicians to help them get the most out of their interaction with drug reps. Maybe an online course to explain industry economics and help doctors ask the right questions.

There are at least a couple of companies I can think of that could benefit from Henry Ford's decision:

PreferredTime, which schedules rep appointments with physicians
Medvantx, which makes machines that provide generic samples in doctors' offices

Grand Rounds is up at Nurse Ratched's Place

2006-12-19T07:55:00.000-05:00

Grand Rounds, the best of the week's medical blogging, is up at Nurse Ratched's Place. Check out the Christmas theme.

Getting the hang of blog-related marketing

2006-12-18T15:58:00.000-05:00

Marketers are trying to figure out how to use health care and medical blogs to pitch their products. A lot of the early attempts have been ham-handed, such as advertising for bariatric surgery on a cancer patient's blog or surrounding posts that criticize drug makers with DTC ads for the drugs mentioned in the blog.

Thinklabs is being more intelligent with its sponsorship of this year's Medical Weblog awards. The company is providing an electronic stethoscope as a prize, touting its sponsorship online and having its PR agency contact bloggers like me.

Clive Smith, Thinklabs' CEO and a blogger himself, says in a press release:

Thinklabs' electronic stethoscope helps doctors and nurses listen to their patients' hearts and lungs with greater clarity. Blogs are the stethoscopes of the Internet, listening out for anything that doesn't ring true, and bringing attention to problems that would otherwise go undetected.

Pretty clever positioning.

Just to make sure people are interested, Thinklabs is throwing in an iPod, which lets users record heart and lung sounds from the stethoscope... or listen to AC/DC while writing up patient reports.

Missing the point on biogenerics

2006-12-18T14:05:00.000-05:00

A Boston Globe article, Lobbyists focus on safety in debate over generic drugs, describes the positions taken by the biotech industry and generic industry over proposals to create a regulatory pathway for generic versions of biotech drugs. In essence:

Biotech manufacturers want generic players to conduct extensive clinical trials before gaining regulatory approval. According to their association, "Unlike a pharmaceutical product, where you can simply demonstrate that you have the same chemical formula and you don't need the clinical data, a follow-on biologic is a very, very different process." Obviously this will drive up the cost of entry dramatically and delay the introduction of new products.
Generic manufacturers admit there is something to the argument, but they want legislation to explicitly authorize biotech generics.

Generic versions of chemically based drugs have helped keep drug spending under control, and there's an implicit assumption that the only way to control biotech prices is with biogenerics. However, there is another way, as I've discussed in A better idea than biogenerics:

Allow biotech drugs to be approved and marketed as they are now, without price regulation
After patent expiration or after a certain number of years on the market, regulate price. The price could be based on cost of goods, a percent of the previous selling price, or some other mechanism

Biotech and generic company lobbyists aren't going to be interested, but lobbyists for taxpayers should be!

Cracking down on abusive medical debt collection practices

2006-12-18T13:24:00.000-05:00

Thank goodness for the Boston Globe. The four-part series on Debtors' Hell that ran over the summer highlighted the abusive nature of the debt collection business. Now, at least some Massachusetts counties are responding.

The headlines from the summer series more or less tell you what you need to know:

Part 1: Preying on Red-Ink America. No mercy for consumers
Part 2: A Court System Compromised. Dignity faces a steamroller
Part 3: Enforcers' might goes unchecked
Part 4: National Crisis, Official Silence. Regulators, policy makers seldom intervene

One of the articles in part four, For some, a bitter remedy for overdue medical dental bills, described the following, all-too-common situation:

When Marcy Armington objected to her obstetrician's bill, believing her health insurance should cover the $300 balance due for the birth of her daughter, she had no idea that such a common dispute would leave her vulnerable to the ''The Hubbard Law Office Experience.''

That would be attorney Richard R. Hubbard of Uxbridge. Hubbard sued Armington on behalf of Dr. Thomas A. Spina of Hopedale - though the suit listed the wrong address, so she knew nothing about it. Last March, two Worcester County sheriff's deputies came to her Milford home to take her car. To keep it, Armington had to pay $983, to cover the $383 court judgment and the $600 sheriff's fee.

Debt collection is a very sleazy business to begin with as the series describes---

Constables...carry badges and have arrest powers -- yet are untrained and unmonitored. [M]any do the dirty work of property seizure for some of the most aggressive debt collectors in the state... In Boston, 88 of the 186 constables have criminal arrest records of one kind or another...

--so I'm not surprised that debt collectors would try these tactics. But what's appalling to me is that unpaid, contested medical bills are considered legitimate debt and that sheriffs so willingly participate. Anyone in the medical field knows bills are often just plain wrong and almost always hard to understand.

There's still nothing like front-page exposure in a big city newspaper to effect change. The Globe reported today that sheriffs in three large counties are no longer seizing cars to repay medical and dental expenses, nor when the amounts owed are less than $1500. Those changes have been enough to drop seizures by half, which tells you something about how common these cases are.

As previously reported, medical bills are a major contributor to bankruptcy filings. Even people with health insurance can end up in BK if they encounter a serious, prolonged illness. One reason is that medical care is expensive. Another is that administrative errors, bureaucratic indifference, and aggressive "debt" collection are enough to drive people over the edge.

Tissue snatchers?

2006-12-15T15:31:00.000-05:00

Author Michael Crichton has a disturbing opinion piece in today's Wall Street Journal (Body Snatchers, 2006) in which he describes a lawsuit over the disposition of prostate tissue samples at Washington University. According to Mr. Crichton,

When [prostate-cancer surgeon] Dr. [William] Catalona left Washington University for Northwestern, he wanted to take... tissues with him. Six thousand patients notified the university that they wished their tissues to go with him. Ignoring the requests of patients, Washington University claimed the tissue collection as its own, and sued Dr. Catalona. In March of this year the district court ruled the collection belonged to the university. Judge Stephen Limbaugh found that the patients had given their tissues to WU as a gift, and therefore the university owned the tissues outright.

Crichton argues that the judge overstepped his bounds and took away patients rights. The ultimate harm will come from patients' loss of confidence in university research centers.

We only have Crichton's side of the story here and I don't find it terribly credible. What does he mean for example that "six thousand patients notified the university that they wished their tissues to go with him?" And why should a researcher be surprised that the university would assert its rights to tissues --or anything else-- that was donated to the university? Why, in general, should we trust researchers more (or less) than universities?

I do agree with his last piece of advice (except the lawyer part),

In short, caveat patiens, keep copies of everything you sign, bring a lawyer to every medical appointment, and always, always watch your back

You won't have to hide your bong

2006-12-14T13:17:00.000-05:00

You won't have to hide your bong

Novo Nordisk failed to convince a federal judge to take Pfizer's bong-shaped insulin inhaler, Exubera off the market. Novo claims Exubera infringes on Novo's patents for insulin inhalation. Novo's product isn't even slated for launch until 2011, which implies a gap of 5 years for inhalable products. If I were an Exubera user I'd be pretty mad at Novo for trying this stunt.

And Novo still has a chance to prove its infringement case and collect whatever damages it's owed. From the Wall Street Journal:

The judge, in deciding not to grant the injunction, said that "money damages will be readily available" if Novo Nordisk were to prevail at trial. "The amount of Exubera users will be easy to track and any decline in Novo's sales due to alleged infringement will be readily ascertainable," Judge Sand said.

Sounds right to me.

Health Wonk review is up at MSSP Nexus Blog

2006-12-14T07:38:00.000-05:00

Health Wonk review is up at MSSP Nexus Blog

Check out the latest Health Wonk Review, a collection of the best health policy posts from the past fortnight, at Rita Schwab's MSSP Nexus Blog.

Lovely, Rita!

Backscatter chatter

2006-12-13T23:46:00.000-05:00

Backscatter chatter

There's been talk recently of using new "backscatter" machines for passenger screening to detect explosives and other dangerous items that a metal detector would miss. Most of the commentary has been about the threat to privacy, since the machines essentially look through your clothes. That's to be dealt with by degrading the images to a certain extent.

I'm not too worried about privacy. After all, how much privacy and dignity do we really have left at airport checkpoints these days any way. On the other hand, backscatter is produced by radiation. In other words passengers will be going through X-ray machines. Patients are getting exposed to some alarmingly high doses of radiation from CT without anyone taking notice, so I wondered about the effects of backscatter on frequent fliers like me who might go through them hundreds of times every year.

I got some reassurance from a Health Physics Society article, which reports that it would take 200 screening scans in one year to reach the federally-defined Negligible Individual Dose. The Nuclear Regulatory Commission considers it safe to hit at least 25 times this number, or 5000 scans per year.

Meanwhile Rapiscan, a maker of backscatter systems, says each full-body scan is equivalent to what a person gets in five minutes from background environmental radiation.

I'm not an expert on this topic but from what I've read so far I'm not as alarmed as I thought I might be.

Preparing to say "bye" to Blogger

2006-12-13T11:05:00.000-05:00

Preparing to say "bye" to Blogger

Blogger and I are getting ready to divorce. (I'm citing irreconcilable differences.) You may notice a couple hiccups on this site over the next few days while I make the transition. (I couldn't manage to post yesterday, for example.) Stay tuned and you'll see a new and improved, Blogger-free site shortly.

Thanks for your patience.

Pharma Pheel Good

2006-12-11T09:41:00.000-05:00

Pharma Pheel Good

From Instapundit:

A GUY WHO WORKS AT PFIZER wrote me about my book -- nothing really relevant here -- but in my reply to him I wrote:

BTW, we love Pfizer in my house because your exotic anti-arrhythmic drug Tikosyn has changed my wife's life. It's genuinely a miracle drug for her.

He emailed back:

I will pass your thanks along to the guys in the lab. You have no idea how much this kind of message matters to them --and to all of us. We KNOW there's a pony in there somewhere but some days it's not easy to remember that.

It's kind of sad that such a small email means so much, but I suppose that these guys get a lot more criticism than praise, despite the miracles they produce. But it occurs to me that -- while so-called "Big Pharma" may not be perfect -- drug companies have done a lot more to make my life better than their critics have. Maybe someone should point that out more often.

Ok, Glenn, it's duly noted.

Correlation or causation?

2006-12-11T09:29:00.000-05:00

Correlation or causation?

Do epidurals 'lead to breast-feeding troubles'?

Women who have painrelieving epidurals during childbirth have more difficulty breast-feeding and are twice as likely to give up within six months than those who give birth naturally, researchers say. Up to 40 per cent of British women are routinely given epidurals during childbirth, involving a catheter being inserted into the spine to allow the infusion of pain-killing drugs. These deaden the nerves that relay sensation from the lower body and legs.

Some of the drugs used in epidurals can make their way into babiesÂ bloodstreams, subtly affecting their brains and making them sleepy and less willing to breast-feed, a study published today in the International Breastfeeding Journal suggests. It is the largest study of its kind.

The most likely cause of the problem was fentanyl, an opioid drug used widely as a component of epidurals, the authors suggest. Such drugs pass quickly into the bloodstream and cross easily into the placenta to reach the unborn baby.

This sounds possible, but it seems unlikely to last more than a day unless there is some huge imprinting effect on a baby's desire to breastfeed or a big rush to substitute a bottle in the first day.

An alternative explanation is that women who opt for epidurals are more likely to give up on breast feeding because of the birth experience, their personality, lifestyle or surgical recovery:

Pat O'Brien, a spokesman for the Royal College of Obstetricians and Gynaecologists, said it was possible that fentanyl had an effect on the baby.

But he added: "There are other factors which may explain this link, including that if a woman chooses not to have an epidural, she may also be more motivated to persevere with breastfeeding.

"Also, a lot of those women who had epidurals also went on to have Caesarean sections which - unless you have a lot of support - make it difficult to breastfeed because it's harder for women to pick their babies up."

Thanks to Mickey.

Road Hazard

2006-12-11T09:03:00.000-05:00

Road Hazard

Check out the winner of the 2006 Not My Job Award.

Mr. Consistency

2006-12-11T08:55:00.000-05:00

Mr. Consistency

I liked what Biogen CEO Jim Mullen had to say when I saw him a couple months back.

He wants us to regain perspective on risk. The "safe and effective" mantra doesn't make sense. Actually drugs are inherently unsafe, even OTC products. Instead we should look at the risk of unforeseen outcomes (i.e., adverse events) versus the risk of forgoing therapy.

On Sunday, he was interviewed in the Boston Globe's On the Hot Seat column. I enjoyed this exchange, which was consistent with what I heard him say before:

Q Do you support the creation of a new group at the FDA to specifically look at post-marketing studies and analyze the incidence of adverse events?
A We don't need a new group. They definitely need some more systems, and we need some harmonization with the Japanese and European regulators. It's a very poor idea to propose a safety agency. It loses context. Safety can only be reviewed in the context of the medical condition you're treating.

Putting the Informed into Informed Consent

2006-12-08T15:48:00.000-05:00

Putting the Informed into Informed Consent

Physicians and clinical trial coordinators often view "informed consent" as just a form that needs to be filled out or a procedure that needs to be undertaken. A common consequence is that those who have consented have not necessarily been well informed. Informed consent should really be treated as an ongoing process, with a chance for patients to absorb and discuss information over time.

A new study of informed consent for clinical trials conducted in the ICU comes to the not very surprising finding that most patients who consented to participation in a trial don't really know what's going on. I would have been shocked if the data showed anything else.

A more useful study, in my view, would examine how many patients undergoing elective procedures or enrolling in clinical trials outside of the hospital understand what is happening.

In health care, the rich and powerful really aren't insulated

2006-12-07T20:03:00.000-05:00

In health care, the rich and powerful really aren't insulated

Princeton economist Uwe Reinhardt wrote a letter to the Wall St. Journal last week, tweaking the Journal for espousing market forces in health care in the form of high-deductible plans. After all, writes Reinhardt, corporate executives often receive generous, lifetime health insurance and are even reimbursed for out-of-pocket expenses. Shouldn't they have "skin in the game," too?

Today the Journal published a thought-provoking response by Matthew Huggins:

Perhaps the... isolation from the market... makes [corporate executives] ill-suited to oversee the wholesale purchase of health-care services for others. [I]nstead of stripping executives of their... coverage, as Prof. Reinhardt wryly suggests, in furtherance of sounder markets, why not strip them of their predominant role in purchasing health-care services? Reassign such purchasing decisions to individual patients by dismantling the regulations and tax incentives that tend greatly to enhance the relative purchasing power of large employers and governmental bodies.

Another letter by Brian Acker pointed out that we don't advocate equality in other sectors, so we shouldn't worry about inequality in health care benefits either.

Actually, there is more equality in access to health care services than there is for most other things. For example, think about disparities in transportation from Boston to Washington:

Lots of people don't have enough money to go. They stay home.
Others take the bus
Some drive --in cars of various levels of comfort
Some fly coach
Others fly first class
Some (like the executives we talked about earlier) go by private jet

Now think about what happens to someone who needs to go to the hospital in Boston

Anyone can go to a top hospital like the Brigham and Women's or Mass General and be treated pretty much the same. You might get hassled by accounting if you don't have insurance, but the doctors and nurses don't tend to give you a hard time based on your economic status
If you're someone special (e.g., a big donor) you might find yourself on a VIP floor at Mass General (though it's unlikely elsewhere). The room's not that much better, though, and you probably won't receive better care. And I'll go out on a limb and say your chance of having something go wrong due to medical "error" is not much affected by being up there. Maybe you can get access to better or more prominent physicians, but not necessarily. And anyway, do you really know how good or bad they are?

Overall, the rich and powerful are highly constrained in their ability to get exceptional service and quality in health care compared to other spheres in their lives. That's one reason that corporate executives are interested in improving the quality and service levels of the US health care system. They are not insulated from commoners in health care the way they are everywhere else. Unlike Huggins, I wouldn't take health care purchasing out of their hands just yet.

A novel idea for measuring quality: focus on the patient!

2006-12-06T22:15:00.000-05:00

A novel idea for measuring quality: focus on the patient!

It's kind of pathetic that this is just being recognized.

Speakers at a forum hosted by the Alliance for Health Reform and the Commonwealth Fund... said that "patient-centered care" is important in efforts to measure health care quality.. [S]peakers said that patient-centered care measures can include the level of patient involvement in their health care, the effectiveness of coordination of care among different providers, routine feedback to hospitals, clinical information systems that support high-quality care and publicly available information on patient-centered care... [T]he Joint Commission Journal on Quality Improvement found that patients who received patient-centered care were less likely to experience complications and death than other patients...

Anything that makes "experiencing death" less likely is probably good.

And the winner is...

2006-12-06T22:11:00.000-05:00

And the winner is...

Medgadget announced the winners of their first annual medical sci-fi contest:

Many of the stories we received involved transferrance of one kind or another: neuron transplants that reversed dementia but caused subtle, creepy personality changes... A mother who gives her all to help a daughter in kidney failure...
But the best story, in our judgment, featured a transferrance of a more primitive, fundamental sort. In the not-too-distant future, with fears of bird flu gripping the planet, scientists race to disseminate a vaccine. We loved everything about this tale -- its exposition and pacing, its dramatic climax, and how it turns the strengths and vulnerabilities of our global community on its head. Just brilliant!

House moves to stop dextromethorphan abuse

2006-12-06T20:30:00.000-05:00

House moves to stop dextromethorphan abuse

In the olden days some kids used to chug cough syrup to get high, and apparently they still do. The internet has also heralded the arrival of bulk sellers of raw dextromethorphan. I did a couple quick searches on Google and came up with places to buy and tips for getting high.

The Consumer Healthcare Products Association has been working with the Partnership for a Drug Free America and Community Anti-Drug Coalitions of America to try to cut down on the availability of dextromethorphan. Today the US House of Representatives passed a bill that prohibits the sale of bulk dextromethorphan to anyone other than FDA-registered drug and device producers. It sounds like a reasonable idea and I hope the Senate goes along.

I'm hopeful that the dex problem can be addressed without having to take cough medicines off drug store shelves. I wasn't thrilled to see Sudafed sales restricted even though I understand why it was done.

There's more information on dex abuse here (check out the animations) and here.

Cavalcade of Risk is up at Cato@Liberty

2006-12-06T15:17:00.000-05:00

Cavalcade of Risk is up at Cato@Liberty

Have a look at the latest Cavalcade of Risk, which is up at Cato@Liberty. Several posts on health care topics, as usual.

Pharma apologists are out in force

2006-12-05T23:16:00.000-05:00

Pharma apologists are out in force

I've gotten a chuckle out of the recent round of post-election scare-mongering articles about how the Democrats are going to destroy the pharmaceutical industry. I had the chance to read two that were published on the weekend:

What's good for pharma is good for America in the Boston Globe, by Hoover Institution fellow Richard Epstein. (I assume the headline is meant to be ironic, but who knows?)
Of Politics and Pills, an interview of Eli Lilly CEO Sidney Taurel by Wall Street Journal's editorial board member Robert Pollock.

Key assertions in both pieces have been exposed as nonsense by the same newspapers. For example, Epstein writes:

One consequence [of regulation] is that it has become ever harder to persuade companies to invest in drugs that attack diseases or conditions that afflict small populations -- thus exposing companies to the charge that they heartlessly put profits before patient health.

Leaving aside for a moment that this "consequence" has occurred under the Republicans, pharma companies have been investing plenty in diseases affecting small numbers of people. They've been so successful in charging high prices for drugs for rare diseases that yesterday's Boston Globe led with a story about how the proliferation of specialty products is a primary driver of the rise in health insurance premiums.

The increasing use of expensive specialty drugs, including powerful treatments developed by Massachusetts biotechnology companies for rare diseases, is making health insurance more expensive for everyone, the state's major health insurers say.

The Wall Street Journal interview was uncharacteristically amateurish. The interviewer didn't seem to have any real understanding of the pharmaceutical industry, but rather a reflexive disdain for any government involvement in the market.

Mr. Taurel tells me how his company responded to the Prozac patent loss by raising R&D expenditures to the highest level in the industry. One of its newer products is Xigris, the first-ever treatment for sepsis, a deadly blood infection that kills more than 200,000 Americans annually...

Why didn't he ask Mr. Taurel to comment on allegations --reported previously in the press-- that Xigris isn't that effective and that Lilly has been using improper practices to influence guidelines and quality measures?

I also liked this line:

Mr. Taurel concedes the government can play a role in funding basic science.

That's awfully gracious of him. A better question might be whether the pharmaceutical industry can play a role in basic science and drug discovery. The evidence isn't encouraging.

I too have concerns about overregulation of the pharmaceutical industry. But we need a more nuanced debate. Articles like the Taurel interview and Epstein opinion piece don't do much to move the debate forward.

Grand Rounds is up at The Antidote

2006-12-05T23:14:00.000-05:00

Grand Rounds is up at The Antidote

Check out the latest edition of Grand Rounds at The Antidote. You'll find the best of the week's medical blogging.