Pharmaceutical research and development: what do we get for all that money?

BMJ ^ | 7 August 2012 | Donald W Light, professor 1, Joel R Lexchin, professor2

[sakic]

Since the early 2000s, industry leaders, observers, and policy makers have been declaring that there is an innovation crisis in pharmaceutical research.

A 2002 front page investigation by the Wall Street Journal reported, “In laboratories around the world, scientists on the hunt for new drugs are coming up dry . . . The $400 billion a year drug industry is suddenly in serious trouble.”1

Four years later, a US Government Accounting Office assessment of new drug development reported that “over the past several years it has become widely recognized throughout the industry that the productivity of its research and development expenditures has been declining.”2

In 2010, Morgan Stanley reported that top executives felt they could not “beat the innovation crisis” and proposed that the best way to deal with “a decade of dismal R&D returns” was for the major companies to stop trying to discover new drugs and buy into discoveries by others.3

Such reports continue and raise the spectre that the pipeline for new drugs will soon run dry and we will be left to the mercies of whatever ills befall us.4

[sakic]

It's a pay to read the article piece, but is summarized a bit more here: http://theincidentaleconomist.com/wordpress/

[the invisib1e hand]

gun control?

[Citizen Tom Paine]

Dear reader: we are witnessing two things. One which is first and foremost is the decline of “Western Medicine” as we have know it. The second is that the major drug companies are not trying to find a “cure” for a disease, they are trying to find a drug which the can patent and make a billion or two dollars from. Under such conditions many promising lines of research will not be funded, and more importantly, good researcers will not be encouraged to follow those lines of research. Such is the state of the world today.

[sakic]

Stories like this should be front page. Unfortunately, very few seem interested in the big picture, only the little stupid moments.

[upchuck]

BUMP!!

You read something enticing about a cure and then never hear any more about it. Happens over and over.

The drug companies are making billions and billions treating symptoms. They’d lose a ton of cash if they cured something.

So what, if any, is the solution?

[stormer]

[upchuck]

As an example of my reply #5 above, go look at this. Wonderful news!! But you won't see that in any lamestream publication.

And I bet we hear no more about this.

[Theoria]

Diabetes May Be Reversed by Long-Used Vaccine for TB

'A tuberculosis vaccine in use for 90 years may help reverse Type 1 diabetes and eliminate the life- long need for insulin injections, say Harvard University researchers raising money to conduct large, human studies. '

-snip-

'Faustman and her colleagues at Massachusetts General in Boston are working to get the vaccine to market. After their early findings in studies with mice, she said they tried to interest every major drugmaker in developing the vaccine as a possible cure for diabetes. All told her there wasn’t enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said. '

[sakic]

You're half-right. You won't see this in any lamestream OR any other kind of large publication. Both sides are on the wrong side of this one.

[corkoman]

It doesn't sound as if you are coming from a position of insight - yes indeed many breakthroughs are given too much press and usually too early. To get a new chemical entity approved by FDA extensive testing is required. Because of an expectation of very low risk, very low, any serious adverse event during clinical testing causes the train to derail.

As for cure vs palliative - ANY company that develops a cure CAN make these billions for which you seem to denigrate. Right now there are several companies sprinting to bring a Hepatitis C cure with drugs that are taken orally - the cure thing is HUGE the ability to do that without the current toxic infusions therapy is HUGER.

I am convinced that the big companies have had to develop such extensive PROCESSES to satisfy FDA and stay in business their internal pharmacology / medical chem / development capabilities are stifled from the bureaucracy. Hence having to buy super expensive small R+D organizations.

[sakic]

Yet medications with major adverse effects hit the market over and over, with some getting pulled.

Imagine how much money would be lost by drug companies if insulin was no longer a needed product. What is their incentive to develop a cheap, generic product to replace insulin, a very major cash cow?

[sakic]

Where are the Jonas Salks of today?

"In 1947, Salk accepted an appointment to the University of Pittsburgh School of Medicine. In 1948, he undertook a project funded by the National Foundation for Infantile Paralysis to determine the number of different types of polio virus.

Salk saw an opportunity to extend this project towards developing a vaccine against polio, and, together with the skilled research team he assembled, devoted himself to this work for the next seven years.

The field trial set up to test the Salk vaccine was, according to O'Neill, "the most elaborate program of its kind in history, involving 20,000 physicians and public health officers, 64,000 school personnel, and 220,000 volunteers." Over 1,800,000 school children took part in the trial.[3]

When news of the vaccine's success was made public on April 12, 1955, Salk was hailed as a "miracle worker", and the day "almost became a national holiday." His sole focus had been to develop a safe and effective vaccine as rapidly as possible, with no interest in personal profit. When he was asked in a televised interview who owned the patent to the vaccine, Salk replied: "There is no patent. Could you patent the sun?"[4]

[onona]

Crap and Drivel.

The article and post is pure $hite

[sakic]

Your comment was expressed beautifully, argued cogently, and eloquent.

[corkoman]

Both good Qs: The requirements for commercial approval include large clinical trials - thousands of patients. There are examples of adverse events that are so rare they are exposed only when millions of patients are exposed. So it may be a severe reaction but of such a small incidence that the risk of the event is miniscule. That’s a problem with all products. But those severe adverse events make headlines.

Insulin is not a patented medicine - anyone can make it if you are willing to pay for developing and obtaining approval for a new generic product. There are billions at stake for developing a cure for Type 1 diabetes - to think that someone would prevent a billion-dollar possibility from going to market to keep selling generic insulin? Does that make sense?

[sakic]

Does it make sense? No.

Is it happening? Yes.

The why seems clear.

[corkoman]

You are saying that there is a potential blockbusting cure but its being kept from the market to keep selling generic insulin? Please share with us your insights on this - please post links unless its just your feelings.

[sakic]

It has already been posted in this thread.. No drug company is interested in pursuing it.

This is not just about drug companies, though. I have had two personal experiences that illustrate how the good of the people is of no importance.

1. In the 70’s I managed a film crew. We filmed the experiments of a scientist who discovered a much better fire extinguisher. The fire extinguisher lobby blocked it.

2. In the 90’s I led a group demonstrating a new way to clean water facilities without using chlorine. Europe already used it back then. At every demo, the people enthusiastically wanted it. The chlorine lobby blocked it.

The problem isn’t gov’t or corporations. The problem is that they are one.

Libs blame corporations. Cons blame gov’t. Until everyone figures it out, nothing will change.

[corkoman]

I checked and it is not included in this thread. Please describe to us your insights on how a cure for diabetes is being withheld to allow the continued sale of generic insulin. Please provide a link. Or are you just operating on feelings. Your dodge makes it sound like feelings.

[SuziQ]

That DOES look interesting. If Universities didn't have to worry about tort lawsuits if someone dies during treatment, apart from negligence by the research departments, the Universities could patent and distribute the drugs themselves. The drugs may not make BILLIONS, like the drug companies prefer, but they could make a tidy profits for the Universities. It would also end the practice of drug companies buying up the patents, then never doing anything with them.

The treatment of all types of cancer is a HUGE expense in this country; just think of how much could be saved on healthcare costs if there were more effective, and lower cost treatments available.

[dfwgator]

“The years passed, mankind became stupider at a frightening rate. Some had high hopes the genetic engineering would correct this trend in evolution, but sadly the greatest minds and resources where focused on conquering hair loss and prolonging erections.”

-Idiocracy

[FreedomPoster]

I expect a good part of the reason for that is that getting the drug approved by the FDA for a new usage is quite expensive.

[Reeses]

FDA regulation compliance and paper pushing make up 90% of the costs. Most executives at pharma companies are lawyers, not doctors. If drug companies can no longer afford to invent new drugs, blame it on lawyers and bureaucrats bleeding the industry to death. Routine costs of doing business include multi-billion dollar fines and judgements. These extra costs are passed directly on to the sick.