Category: Policy and politics

Disclosure isn’t enough

published date
November 30th, 2006 by

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.

Abortion in the UK and Spain

published date
November 28th, 2006 by

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.

A better idea than biogenerics

published date
November 27th, 2006 by

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.

All you really need to know about “unschooling”

published date
November 27th, 2006 by

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.

On Fairness and Rationality

published date
November 20th, 2006 by

On Fairness and Rationality

One of the enjoyable things about trade publications of any kind is their tendency to take the side of their readership. It’s especially comforting in industries where it seems like no one understands you. I especially liked the lead headline in today’s “PharmaLive Product Marketing Weekly”:

NICE Subject to Potential Judicial Review Following Unfair and Irrational Decision on Treatments for Alzheimer’s

Basically, Eisai and Pfizer are upset that their product, Aricept won’t be getting reimbursement from the NHS as they’d hoped for. Would they have objected to an “Irrational” but “Fair” decision? (No.) How about an “Unfair” but “Rational” one? (Probably.)