Health Business Blog

Disclosure isn’t enough

Most cancer patients in clinical trials don’t care if their doctor has financial ties to the trial’s sponsor, according to a study decribed in the Washington Post. The article says the survey

undermines “full disclosure” as a central tenet of clinical research.

The authors think that patients may be too overwhelmed by their disease to think critically about such conflicts. That may be true. However, I’m not surprised that disclsoure doesn’t work. It reminds me of the situation in financial services, where equity analysts with clear conflicts of interest wrote bullish reports on the companies they covered. Those conflicts were often disclosed but it didn’t stop investors from treating the reports as objective. More likely, the investor or patient assumes the analyst or doctor will bend over backwards to ensure objectivity once disclosing the conflict. That’s a bad assumption.

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Roll on Columbia, roll on

From the Columbia University Spectator:

When it comes to patents, Columbia is the big man across campuses.According to the University, patent-related deals pulled in more than $230 million in the 2006 fiscal year, more than almost any other university earned on such deals. The University has made patent-building one of its most significant endeavors, focusing on high-powered discoveries and pushing scientific research toward lucrative investment.

In light of this, other institutions have taken a cue; the Crimson reported in November 2004 that after Harvard made $24 million to Columbia’s $178 million in 2003, the university planned to overhaul its own technology transfer office in hopes of cashing in.

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Grand Rounds is up at Notes from Dr. RW

Dr. RW Donnell has done a nice job putting together this week’s Grand Rounds. I even got the email address right this week so my submission is included.

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Abortion in the UK and Spain

A couple of articles in European newspapers today reveal a real difference in attitudes between the US and Europe. In More women have abortions as it loses social stigma in The Daily Telegraph, the head of the British Pregnancy Advisory Service (BPAS) says,

The idea of just drifting into unplanned motherhood is seen not to be a good thing and you could argue that among many groups of people in society abortion is seen as a more responsible response to being a victim of uncontrolled fertility

There’s one small paragraph devoted to a rebuttal from an anti-abortion group. It’s an interesting attitude to consider fertility as a nuisance.

An article from Spain’s El Pais (La mitad de las extranjeras que aborta no emplea anticonceptivos, segun un estudio) presented the results of a study by an association of abortion clinics about the characteristics of immigrants who have abortions. Half don’t use contraceptives, 8 in 10 are ignorant of the morning after pill, and many lack good access to health and family planning services. The study recommended providing better access to health services. The article treated the study as a typical public health report and didn’t include any political commentary.

I wonder whether European countries will ever tie the abortion/fertility issue to the continent’s low birth rate.

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Hospital financing in France

Saw this cute little item in The Daily Telegraph on my way back to the US.

The chairman of Paris Saint-Germain football club is to contribute to the hospital fees of a member of a racist, anti-Semitic group of fans injured by a black policeman during an attack on a rival Jewish fan…

Another PSG fan died after the policeman opened fire when around 100 hooligans attacked him last Thursday. The officer was shielding a supporter of the Israeli club Hapoel Tel-Aviv, who the fans were trying to assault outside the… stadium.

Politicians and commentators regularly accuse PSG of turning a blind eye to fans with links to the far-Right.

I wonder why.

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A better idea than biogenerics

Generics are a bright spot in the world of health care costs. Safe, efficacious generics are available in an increasing number of key therapeutic classes. Producer level prices have been low for years. Thanks to Wal-Mart those low prices are now making their way through to patients. With Democrats in control of Congress, barriers to the introduction of generics are likely to fade.

But there’s a large and growing exception to the generic trend: biotech. Biotech drugs are an expensive and rapidly growing component of drug spending and the trend is likely to continue.
It’s hard if not impossible to make exact copies of biotech drugs and there’s no clear regulatory framework for their approval. According to the Wall Street Journal (Democrats’ Rx? Generics):

Some biotech officials argue that generics makers will need to redo all the studies performed by the original manufacturer, in order to guarantee their copycat products are effective and safe for patients. That would likely eliminate much, or all, of the price advantage offered by the generics rivals. “There is no way to characterize a biological,” says James Greenwood, a former congressman who heads the Biotechnology Industry Organization, a trade group.

You should take the self-interested statements above with a grain of salt. Still it probably doesn’t make sense to apply the same generic model to the biotech industry, even though it’s worked well for traditional drugs. Instead I suggest the following:

• 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

This would avoid the costs and risks of biogeneric development and regulatory approval while delivering the benefits of lower costs to payers. The original maker of the product should be happy too. Although their price will be lower than it is today, they won’t have to share the market with generic players or spend money blocking the entry of new players. They will still enjoy a substantial period of high margin sales as they do today. It just won’t go on forever.

When, at some point in the future, science improves to the point where truly identical biogenerics can be developed, these rules could be revisited.

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Another reason to be cautious about early PSA screening

Some researchers now advocate starting PSA screening for prostate cancer at age 40, rather than 50. The idea is to establish a baseline that is useful in interpreting scores later on. I expressed my objection on the basis of the stress of false positives. However, I didn’t think about the potential pain of the biopsy itself until I saw Tara Parker-Pope’s Health Mailbox column about it in the Wall Street Journal. Lots of readers wrote in and a good number had something unpleasant to say about the procedure. It’s anecdotal information but worth considering.

First, on the positive side:

“It was totally painless. I would suggest that routinely calling it a painful procedure is a mistake. It depends on the doctor’s skill and how the patient reacts to the anesthetic, and can range from totally painless on up.”

“I just went through the procedure yesterday… Piece of cake…”

Others were less encouraging:

“…I had six biopsies, and each was worse than the last. True, I had no anesthetic, and I can tell it you, it really smarts. Then for quite a while you have bloody red ejaculate, which is another turn-off they don’t seem to mention.”

“The biopsy was for me terrible. I have learned that like so many things with prostate cancer it varies greatly from one man to the next. The prostate surgery itself was a piece of cake by comparison.”

From my perspective, it’s worth taking into account the physical and emotional downsides of a biopsy when deciding whether to have a PSA test in the first place.

Disclaimer: I’m not offering medical advice. Figure out with your doctor what makes sense for you.

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All you really need to know about “unschooling”

I got a chuckle out of a front-page article in the Sunday New York Times about “unschooling” (No School, and the Child Chooses What to Learn.)

On weekdays, during what are normal school hours for most students, the.. children do what they want. One recent afternoon, time passed loudly, and without order or lessons, in their home…

As the number of children who are home-schooled grows — an estimated 1.1 million nationwide — some parents like Ms. Walter are opting for what is perhaps the most extreme application of the movement’s ideas. They are “unschooling” their children, a philosophy that is broadly defined by its rejection of the basic foundations of conventional education, including not only the schoolhouse but also classes, curriculums and textbooks…

What kind of parent would be foolish enough to choose this path for their kids? There’s a clue later in the article:

Ms. Walter, a natural-childbirth instructor, has had to assuage tense feeling from some of her peers.

Natural childbirth can be a wonderful experience when everything works out well. The natural childbirth advocates have some valid criticisms of the medical system, and unschoolers have some valid criticisms of the education system.

When natural birth advocates include a rigid insistence on home birth and a rejection of OBs, results can be devastating when things go wrong. I’m willing to bet the unschoolers are going to cause society plenty of problems.

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Happy Thanksgiving

Enjoy your turkey or tofurkey.

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The future of Rx marketing

Pfizer is taking an unusual tack in marketing its new smoking cessation drug, Chantix, according to the Wall Street Journal. Rather than taking an aggressive approach –which it could, considering the product has demonstrated superiority over existing treatments– Pfizer is soft-pedaling the drug with consumers and physicians.

Insurers are reluctant to pay for smoking cessation drugs, so Pfizer is focusing on the self-pay segment. Pfizer is offering the product at a moderate price and is providing support systems, including call centers, to help customers succeed in stopping smoking. As consumers begin to get used to going without drug insurance, expect more brand name pharma products to be pitched to customers who are paying themselves, and for companies to provide realistic information about what the drug can and can’t do. It will be an effective antidote to the backlash against over-promising DTC campaigns and heavy physician detailing.

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