Can the NIH Innovate Faster than Industry?

So it’s come to this: The federal government plans to entice industry with basic bench, and maybe even clinical trial results, to spur drug development.

Concerned that so few promising drugs are in the pipeline, that let alone meet FDA standards, the NIH is setting up a new research shop. Anticipating that penny-pinching Republican House members may give him a hard time about his idea, NIH chief Frank Collins is willing to “cannibalize other parts of the health institutes to bring more resources to the new center,” says the Times.

“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he told the Times. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

For those who need a recount: The FDA approved 21 drugs in 2010, 25 in 2009, and 24 in 2008. No drugmaker, says Fiercebiotech, had more than one drug approved last year. The approval rules are getting tougher: We all saw what happened with the obesity drugs. Collins said in the Times article that industry’s “productivity has been declining for 15 years.”

It doesn’t look like many drugs will be approved this year: The Street said in January that 26 were in the queue and one’s already been rejected: Contrave, the obesity drug.

Industry is all tied up in what it considers a bad situation. While profits are increasing for some members, companies choose to focus on patent expirations, tough regulators – on both sides of the Atlantic – the new U.S. health care reform, and no doubt myriad other issues.

Fiercebiotech penned the apt phrase: A wave of impatience has crashed over the drug development and discovery business.

How did we get here? Another phrase is apt: The perfect storm.

Pharma’s past behavior forced overregulation, which added more costs to R and D. And since no one in discovery appears willing to give up its quest for innovation – read blockbuster – the costs of discovery continue to rise. So mergers and acquisitions make sense, which in our experience has drained talented R and D personnel.

So, academic researchers and advocacy groups may be the ones who drive new innovation, but it's doubtful they'll have enough funds to see any product through all the regulatory challenges. It appears to us no one is reconciling the priorities with the limited dollars available.

In our opinion: Drug research is too inefficient.

Industry critics continue to scream that pharma spends way too much on marketing and has no reason to cry poor mouth. This may be true: But the fact remains that collaboration in pharma is still a business, and pharma must answer to a board of directors, shareholders and its own future. As for the NIH, do we have evidence that research dependent on the federal government for basic bench research is the way out of this mess?

We believe both parties can find new ways to conduct research and conduct clinical trials. We just began working with a company that's ready to break down some of those challenges. We suggest this type of communication, knowledge management and performance measurement tool can help all parties involved in research. 

A comment from researcher Hugo Geerts posted on the Fiercebiotech article regarding the huge dependency on animal studies is another excellent point to consider.

His suggestion: Pharma should use more computer-based mechanistic disease modeling.

Pharma: It Must Invest in Improving Health Outcomes

If you're a businessperson and you see an opportunity, don't you take it? Especially if the opportunity is in a business that doesn't seem particularly interested in protecting its territory.

The territory we’re talking about: the quest for improving health outcomes. In a new Ernst and Young report, the authors say that non-traditional companies are investing in projects designed to improve health outcomes. To be sure, some of these partners are traditional, like Apple and Abbott Labs.

The non-traditional investments far outweigh those of Big Pharma. The non-traditionalists have spent $20 billion since 2006; Big Pharma’s figure was not given, but it wasn’t close to that, according to a Bloomberg story.

The authors say that Big Pharma has no choice but to invest in improving health outcomes, and for two reasons: the current health care system is not sustainable -- but new technologies can make it so. These technologies, the writers say, can drive behavioral change.

Examples of these projects include the insurer UnitedHealth Group, the YMCA, and Walgreens, which are working together in a diabetes management program. Others, according to Bloomberg, include GE, Telus Corp, a wireless carrier, and IBM.

One company, called PharmaTrust, based in Toronto, is creating a device called MedHome that dispenses the appropriate amount of medicines to patients in their homes. At the same time, it communicates with providers and caregivers about patients’ compliance, according to the report.

And Qualcomm, the mobile technology company, is hoping to increase compliance and health outcomes with its “connections:” an Internet-connected pill bottle cap designed to increase compliance and also lets patients refill prescriptions by pushing a button on the underside of the cap; and a “connected” blood glucose meter that tracks how often patients are testing themselves and reminds them when they are running low on supplies. They can even reorder from the device.

“Pharma is significantly behind the medical device industry in thinking about connectivity and using its power for productivity and business model innovation,” wrote one Qualcomm exec.

All we are suggesting is that innovation may quickly become the domain of others. What are the unintended consequences of this lack of pharma innovation? 

Can Pharma See Wisdom in the Sell-Off?

The Street is pushing Big Pharma members to sell off their non-core assets. Why? To keep stockholders happy, of course. Even the media-deprived know that last year was not a stellar year for pharma, finance-wise or any other wise.

The Street people are arguing that some Big Pharma members are worth more dissected than they are whole. If Abbott Labs, for example, were torn asunder and its various pieces sold off, it would make a handsome profit, and its stock price could jump 30%, according to an analyst quoted in Barron’s.

Obviously, that money could be used for what’s needed: R and D.

FiercePharma brings up the point, and it’s a good one, that such dissection would run counter to what pharma members have been trying to do with all these mergers and acquisitions, and that is survive – a sophisticated way of hitting the mattresses, if you will.


Our two cents: We’re with the Street, but not for the same reason. We think it’s time for pharma members to get back to their roots, and that is Research and Development, 24/7. If discovery, trials, regulatory, and so on were the same as they were 30 years ago, it would be one thing, but they are all much tougher today. The amount of focus and concentration needed is exceptional.

Too many divisions cause too many distractions, too many worries.

Barron’s is right: Bigger is not always better. In fact, it can be a real burden.

Clinical Trials: Is Full Disclosure Necessary?

Here’s a hypothetical: Your 85-year-old mother, who has Alzheimer’s, has the chance to enter into a clinical trial for a new Alzheimer's disease drug. Possible dilemma: The type of drug your mother will receive is similar to one that just failed in another trial – in fact, it caused harm. Do you want to know about that failed trial? Is the trial sponsor under any obligation to tell you about it?

The New York Times, which recently discussed the pros and cons concerning full disclosure in clinical trials, said Alzheimer's disease patients and their caregivers may be different than other patients. Cancer patients may want to know all details if a trial is stopped; Alzheimer's disease caregivers, too tired from the daily grind, may not. Certainly, we’re talking about different diseases here: People can survive some cancers. For Alzheimer's disease, there is no cure.

The basis for the article was Eli Lilly’s decision to stop its huge trial on semagacestat because patients showed worse cognitive functioning than those on placebo, and increased skin cancer risk. According to the article, Lilly's drug disrupted gamma secretase, but was an older generation of this drug class. The newer disrupters, the article said, may be safer.

Of course, trial participants sign consent forms. They acknowledge that the drug may not help; there may be side effects; they may not get better -- or even worse. But our point is that industry members could help themselves in the court of public opinion if they take a few more steps to notify trial participants about why a trial was canceled. Leaving this to the clinic that recruited the patient initially is one of its responsibilities, but it should not fall just on that clinic.We encourage industry to consider this approach as a way to invest in its depleted "trust" bank account with patients.