RSS

Revolutionary Change in How Drugs Are Discovered!

Francis Collins, the Director of the NIH, has started a new effort to socialize part of the research effort.

There is a huge barrier between basic science and practical development of therapy. That barrier is MONEY. Francis Collins, Director of the NIH, wants to solve this by creating a government-run drug discovery effort withing the NIH. Nowadays, there are many ways that drugs receive funding. Sometimes the receive it from a private organisation with a personal stake in the development, then there are people like Lindsay Rosenwald who owns a number of corporations that finance drug startups for the development of medicine that, otherwise, would never have seen the light of day.

As for Francis Collins, his reasons for doing this may worry a lot of people. For all the crying from Michael Moore about the costs of American medicine, hidden in that cost is a simple fact. Almost ALL of new drug development comes from the American market. The reason is simple. It costs $500,000,000 to 1 billion to do the trials needed to prove that a drug can work. Even the kindliest of drug company executives can only commit that sort of money if they see a profit. When no profit is visible, then no money is available.

Since most foreign countries practice socialized medicine, the incentives to develop new drugs are her … in the lucrative USA. Healthcare reform in the USA threatens drug discovery world wide!

The corporate process is this: If we biologists show that some molecule is likely to affect disease, drug companies screen large libraries of potential drugs to see if any of these work. While this part of their process does not cost the billions needed for clinical trials, its does mean that each large drug company has a huge investment in its own database of molecules and the effects of these molecules.

Collins effort should work to decrease the costs of competition. A small startup will no longer have t sell its soul to some over capitalized bug company, to access the tools needed to find a small molecule that works. This an example of socialism fascillitating capitalism!

I see three issues with this.

First,I wonder ift i might not be cheaper for the federal government ot offer to buy out the IP? If this new center is going to replace the value of having your own data, why wouldn’t the drug companies want to make the best of the deal by selling what they have to the public domain?

Second, the information from this new center will be public, as available to foreign companies as it is to US start ups. Is this a good idea?

Third, the cost of clinical trials will remain high. If the new molecules are not proprietary, why would pharma spend the money to develop them?

From The NY Times: (Excerpted)

… drug industry’s research productivity has been declining for 15 years, “and it certainly doesn’t show any signs of turning upward,” said Dr. Francis Collins, director of the (NIH and former head of the Human Genome Project.)… Collins has been predicting for years that gene sequencing will lead to a vast array of new treatments, but years of effort and tens of billions of dollars in financing by drugmakers in gene-related research have largely been a bust.

As a result, industry has become far less willing to follow the latest genetic advances with expensive clinical trials. Rather than wait longer, Collins has decided the government can start the work itself.

The job of the new center, to be called the National Center for Advancing Translational Sciences, is akin to that of a home seller who spruces up properties to attract buyers in a down market. In this case, the center will do as much research as it needs to do to attract drug company investment.

That means that in some cases, the center will use one of the institutes’ four new robotic screeners to find chemicals that affect enzymes and might lead to the development of a drug or a cure. In other cases, the center might need to discover not only the right chemicals but also perform animal tests to ensure that they are safe and even start human trials to see whether they work. All of that has traditionally been done by drug companies, not the government.

“None of this is intended to be competitive with the private sector,” Collins said. “The hope would be that any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector.”

…….

Under the plan, more than $700 million in research projects underway at various institutes and centers would be brought together at the new center. Officials hope the prospect of finding new drugs will lure Congress into increasing the center’s financing well beyond $1 billion.

Hopes of new money may be optimistic. House Republicans have promised to cut the kind of discretionary domestic spending that supports the health institutes, and officials are already bracing for significant cuts this year.

But Collins has hinted that he is willing to cannibalize other parts of the health institutes to bring more resources to the new center.

….. Mark Lively, a professor of biochemistry at Wake Forest University and a member of an advisory council to the research resources center, said he could not understand why the administration was moving so quickly with its plans.

“And the NIH is not likely to be very good at drug discovery, so why are they doing this?” Lively asked.


Your Comment