Comments on: HDL Cholesterol May Not Help The Heart After All

By: Nathan

Nathan — Thu, 05 Jun 2008 00:56:36 +0000

Condor,
$1 Billion was spent on a single CV mechanism of actions. Far, far more than that is being spent on the entire field of CV research. If I had to take a stab at it based on my company’s expenditures, I would say that about 15% of research budgets are spent on CV research. At my company, about 20-25% is spent on cancer research.

I realize that in this comment thread no one has suggested we can buy off the FDA. It has, however, been suggested many times that big pharma can simply get nearly anything approved given enough money. The failure of this $1 billion to generate a single drug (so far) clearly illustrates that cold, hard science is really behind drug approval — not behind the scenes payoffs. That was my point. (I realize you weren’t suggesting this, but I know full-well many commenters on this site believe that to be true)

By: Condor

Condor — Wed, 04 Jun 2008 23:13:44 +0000

Hi Nathan — I guess I missed the part of anyone’s post where it was insinuated that the FDA can be “bought” — I know just the opposite to be true. Odd, though, that you’d phrase it in that way, when no one suggested it.

Now, actually — over 41,000 people die in car crashes in America each year, far outstripping death by CVD — that, in fact, is the No. 1 preventible cause of death in America, Nathan. See the Federal Department of Transportation report:

http://hazmat.dot.gov/riskmgmt/riskcompare.htm

But of direct concern to pharma, here, according to the CDC’s 2006 report, of the 220,267,000 Americans over the age of 18, 15,820,000 had one or more forms of cancer, while a slightly larger number, or 24,107,000 had some form of heart disease. See this PDF:

http://www.cdc.gov/nchs/data/series/sr_10/sr10_235.pdf

So, if I were to accept your figures as generally accurate — $40 to $50 billion spent, annually, in pharma research — I guess I’d ask why are we spending ONLY $1 billion on R & D in the field of heart disease?

How much is spent in R & D in the field of cancer?

Where is the other 98 percent going? [And I KNOW it doesn't go to payola for FDA or EU authoriites, to be silly, but also abundantly clear.]

So, I guess I do see a fair basis to question competencies of pharma management — IF your R & D figures are accurate.

By: Nathan

Nathan — Wed, 04 Jun 2008 15:39:52 +0000

Condor,
Cardiovascular disease is the #1 killer in the US and accounts for 30% of ALL deaths in the US every year. Is that $1 billion in research really due to incompetent management? We spend about $40-$50 billion EVERY YEAR in pharma research. This $1 billion was a drop in the bucket.

In spite of what many of you think, big pharma money won’t buy anything at the FDA - only good science will get a drug approved.

By: Condor

Condor — Wed, 04 Jun 2008 14:49:42 +0000

Ding! Marilyn Mann hit that nail on the head.

It may be a three-or four step (or more) chain — low HDL, tied to ?, tied to mutations(?), tied to increased risks, tied(?) to the MECHANISM used to raise HDL levels — as opposed to any simple one-for-one cause and effect.

And Nathan — this level of spending (north of $1 billion!) probably tells us more about the relative competencies of management at some drug companies — than it does, about what such drugs really cost. [Or SHOULD cost.]

By: Lipid Doc

Lipid Doc — Wed, 04 Jun 2008 14:43:41 +0000

I think that this is an extrapolation that goes too far. Just because low HDL-C levels in this population do not confer increased risk for CVD eveents, doesn’t mean that low HDL-C in patients with high LDL-C and TG or high CV risk will not be of benefit. Either way, we need evidence to decide. Epidemiologic results sometimes yield strange results.

By: Marilyn Mann

Marilyn Mann — Wed, 04 Jun 2008 12:48:00 +0000

Aren’t there studies of the effect of HDL levels that control for trigs and remnant lipoproteins? Anyway, the questions of whether low HDL due to a particular type of mutation is linked to heart disease, and whether a drug that raises HDL by some other mechanism prevents heart disease seem like quite separate issues.

By: CMC guy

CMC guy — Wed, 04 Jun 2008 03:34:01 +0000

Laurie this is just the scientific method in the real world IMO. Everything starts as an idea then assumptions/connections get built and tested with often limited real solid/complete evidence and correlations so always on the edge of unknown. Don’t know full story yet does seems could have been questioned sooner. Here it seems that had animal models where translation to humans not holding up which is regular part of pharma (cancer cures in mice). Common sense may suggest most scientists should have gone to business or law school rather than pursue careers of continual frustration and infrequent successes that most endure.

By: Laurie

Laurie — Wed, 04 Jun 2008 02:20:16 +0000

One billion dollars spent on a drug to treat something that “may” not be a pathological problem. Common sense would tell one to confirm the negative effect of a condition before making a drug to treat it.

By: Nathan

Nathan — Wed, 04 Jun 2008 01:19:09 +0000

More than $1 billion spent pursuing something that may not even produce a viable drug… That should give everyone a clue why drugs are so expensive.