Sunday, March 25, 2012

Drug Companies Fail to Promote Life Saving Drug Tranexamic Acid Because . . . Wait For It

There is Very Little Profit In It

There is a low cost generic pharmaceutical that saves lives.  It help reduce blood outflow from a trauma event.  It is used in war zone and saves the lives of soldiers.

For months, a simple generic drug has been saving lives on America’s battlefields by slowing the bleeding of even gravely wounded soldiers.

  It could be used in hospitals to treat trauma victims and save thousands of lives each year, but 

its very inexpensiveness has slowed its entry into American emergency rooms, where it might save the lives of bleeding victims of car crashes, shootings and stabbings — up to 4,000 Americans a year, according to a recent study.

So what’s the problem?

Because there is so little profit in it, the companies that make it do not champion it.

The first question that comes to mind, is it safe?  Apparently so.

The drug, tranexamic acid, has long been sold over the counter in Britain and Japan for heavy menstrual flow. After a groundbreaking 2010 trial on 20,000 hemorrhaging trauma patients in 40 countries showed that it saved lives, the British and American Armies adopted it. The World Health Organization added it to its essential drugs list last year, and British ambulances now carry it.

And it is gaining acceptance in American hospitals, albeit slowly.  This is in large part because physicians dedicated to savings lives as opposed to making money for drug companies are leading the way to get the drug as a treatment for American soldiers.

The United States Army took note when the drug was used on its soldiers in British Army hospitals.

“So we had a dog in that fight,” said Dr. Todd E. Rasmussen, an Air Force colonel who is now deputy commander of the Army Institute of Surgical Research in San Antonio.

American surgeons were skeptical, he said, until he led a follow-up study, called Matters, which looked at the fates of 896 British patients.  It found that severely wounded patients who got the drug survived twice as often as those who had not; that convinced his American colleagues.

So where do things stand now?

Many companies in India and China make tranexamic acid. Pfizer, which makes an injectable form for hemophiliacs (and donated thousands of doses to the Crash-2 trial), declined to give sales figures or even discuss administering it to trauma patients because the Food and Drug Administration has not approved that use. A company spokeswoman declined to say whether Pfizer had applied for approval. (Doctors may prescribe approved drugs for “off-label” uses, but drugmakers cannot endorse off-label uses without F.D.A. permission.)

One can be fairly sure that if Pfizer will not say if they had applied for approval to sell the drug for treating trauma, then they probably have not done so.  After all that would be expensive and the profits may not justify the expense.  It would be interesting to listen to the discussion where the decision is being made about whether or not a seek approval for the drug.

Scientist:  If we get FDA approval we can market this drug in the fight against people bleeding to death and save thousands of lives.

Corporate:  What is the rate of return on our investment in getting approval?

Accountant:  About 2% if we are lucky.

Scientist:  Most of the trial work is already done, it will be very quick and inexpensive to get approval.

Corporate:  We are not in business to save lives, our jobs are to get profits for the shareholders and million dollar bonuses for the executives.  This doesn’t look like a way to do that.  Is there any way we could monopolize the market and charge a huge price for the drug?

Accountant:  No, it is already in generic form. 

Corporate:  Well, too bad, we’ll just have to take our lumps from those bleeding heart liberals who think medicine should serve the patient.  Besides, if we don’t get approval on this thing those bleeding hearts may bleed to death.  Ha Ha.  Hey that’s a joke people, lets hear some laughter.

In America that is called “free markets in action”, you know, the thing that makes this the greatest country in the world.    In the rest of the world that is called a tragedy.

1 comment:

  1. Congress needs to provide for the NIH's doing trials directly in such cases.