Category: Policy and politics

Pharma apologists are out in force

published date
December 5th, 2006 by

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:

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.

Enquiring minds want to know

published date
December 4th, 2006 by

Enquiring minds want to know

Found this disturbing piece in the New York Times:

BILL CLINTON’S identity was hidden behind a false name when he went to New York-Presbyterian Hospital two years ago for heart surgery, but that didn’t stop computer hackers, including people working at the hospital, from trying to get a peek at the electronic records of his medical charts.
The same hospital thwarted 1,500 unauthorized attempts by its own employees to look at the patient records of a famous local athlete, said J. David Liss, a vice president at NewYork-Presbyterian.
The usual approach has been to allow types of personnel who need to see the records to have access and log the results. But logging means nothing without consequences for improper access. What did Columbia do to discipline those who tried improperly to access celebrity charts?
It may be necessary to have a person monitoring the process in real time and denying access in some situations. This is what happened in the era of paper charts for a patient not in the hospital. For a patient in the hospital the chart sat in a rack and if there was a parade of people coming to peek they would have been stopped.

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.