Not respectful –> no response.

John

The relative meaninglessness of most external sanctions with the possible exception of very large product liability lawsuits (like fen-phen’s $20B). Otherwise, as has been noted, even the highest penalties can be “folded in” in a number of ways.

All that said, I would certainly be interested in thinking about ways of adjusting the system so that extending exclusivity might be a “reward” for other things–no fraud/negligence violations over a period of time; appropriate ROIs (understand can of worms); and so on. I see nothing sacred in any aspect of the incentive/discincentive strucure that could not, conceivably, be changed.

The discussion will come down to chicken/egg type questions. On the farm as it stands, I’d change the barnyard first and see whether, indeed, we see changes in pricing, quality, significant innovation, amount of malfeasance, etc.–all that we’ve been promised over the years if we only got rid of (you name it): FDA, product liability, limits on off-label promotion, Hatch-Waxman…..

It may have seemed like it, but it was not so.

So when one departs from a false premise, all the rest falls, of its own weight.

Namaste

When was this halycon era when you were a kid? Serious questions. As you know, the Kefauver-Harris amendments were originally about price fixing. It was only after thalidomide that they turned out to be about safety, efficacy, and scientific evidence.

The Senate hearings of the late seventies were largely the same.

Anyway, taken from another context, here is my own summary about the structural sources of “moral hazard.” As you’ll see, many of the points are the same, or close, to yours:

“There are certain structural features in the industry that make it extraordinarily easy to “stray.” These include: the always-ticking patent clock, the “blockbuster model” on which company’s entire annual sales depends on the fate of a few products, an enormously competitive marketplace which is not conducive to the highest standards if a company is to fare well (often bemoaned by CEOs themselves); a relatively malleable FDA; the “evidence-free zone” before a drug’s full array of risks and benefits are known (which may be a number of years); the ease (and sometimes accuracy) of demonizing one’s “enemies” (trial lawyers, ambitious politicians, muckraking journalists, etc.); the ease of resting on the laurels of the good things one’s company has genuinely done; and the fact that the great majority of people will continue to rely on the industry, whatever problems arise. Given these and other factors, it is, in a way, surprising that things go as ethically well as they generally do.”

Given the factors that go beyond H-W, I’d like to see anything more that can help us understanding the impact of H-W in particular; and that shows, reasonably enough, that its costs (which are real) outweigh its benefits (which I believe are also real)

In that mythical land bounded by “reality“, “thoughtfulness” and “respect“. . . I offer an earnest question — in reply to yours:

Do you really, thoughtfully and respectfully mean to suggest that LONGER periods of patent monopolies on live-saving drugs would SOLVE any of the ills you’ve perceived?

I am sorry, sir, but I cannot even conceive of a straight-faced argument in that direction. Yours is a classic non-sequitur.

If I’ve misunderstood you, please elaborate.

Otherwise, there is little point or purpose — to addressing your supposed con-numb-drum.

With all due respect,

Namaste

When I was a kid, pharmaceutical companies produced new products, ran the clinical trials, and sold the products for (by current standards) affordable prices in perpetuity without generic competition. Henry Waxman thought these prices were too high, and decided to fix the system by making it easier to bring generic drugs to market. The Hatch-Waxman act dramatically lowered the bar to generic market entry by allowing generic companies to use innovator companies’ proprietary clinical trial data to obtain approval of their products.

So, pharmaceutical profits plummetted and consumers saved tens of billions of dollars per year, right?

What actually happened is

1) As one might have predicted, innovator companies raised the prices on patented drugs to replace the profits lost due to generics.

2) We created two classes of patients. Those who use new pharmaceuticals in the first 10 years or so they are on the market (who pay out the nose and thereby provide the innovator companies with their return on investment), and those who use them after they go off patent (who pay only for the cost of manufacturing).

3) We created an industry made up of large cap companies that derive most of their profits from 3 - 5 products (instead of say, 20 - 30), each of which can only be replaced by a risky, extraordinarily expensive, 10 - 15 year development process. Isn’t this pretty much the definition of moral hazard?

Realistic, thoughtful, respectful comments will be responded to in kind.

“The aniti-pharma crowd…chhoses to live in an alternate reality in which they envision a Utopian world where all drugs would have 100% efficacy with no side effects.”

No. Those who speak critically of particular episodes are usually asking some version of the questions:

1. What did they know?
2. When did they know it?
3. What did they do?

It is certainly true that answers to such questions can often be complex and open to a range of plausible interpretations. But the “Utopian world,” as described, is something I’ve never heard or imagined here.

What if Pasteur’s Germ Theory of Disease is wrong? What about the risk of promoting antibiotic resistent and antiviral resistent microbes throughout the Third World?

“There are no specific diseases; there are specific disease conditions.” - Florence Nightingale

“Illnesses, hover constantly above us, their seed blown by the winds, but they do not set in the terrain unless the terrain is ready to receive them.”—Claude Bernard.

“Bernard avait raison. Le germ n’est rien, c’est le terrain qui est tout.” (‘Bernard was right. The seed is nothing, the soil is everything.’)—Louis Pasteur

http://www.whale.to/v/nightingale_h.html
http://www.theadjustingroom.com/Weekly%20Reader%2020%20February%202009.pdf
http://www.webmm.ahrq.gov/perspective.aspx?perspectiveID=62