It’s about Cancer, Stupid.

Lance Armstrong’s cancer forum is putting the wrong people under the lights. Even if the presidential candidates found a cure for cancer right there on stage, with the way the media covers politics the rest of us would never know. How is it possible that after discussing their approaches to winning – dare I say it – the war on cancer -- the headlines are about which candidate is willing to take which lobbyists’ money? I thought journalists were taught not to bury the lead. Well the lead is the toll in death and suffering cancer is taking, not the campaign contributions candidates are taking.

The press continues to confuse healthcare economics with curing diseases. The benefit of Lance’s gathering is it forces candidates to go beyond the “more money” argument and into how they would change something. In a discussion about curing and surviving cancer, it is folly to debate which lobby groups are “acceptable” as donors. The last time major health players were left out of the game, they defeated a popular President by putting two actors playing man and wife sitting around a kitchen table shaking their heads. If we are going to create medical solutions for cancer, we will need everybody at the table with open minds, collaborative natures, and valuable human and financial resources. And not shaking their heads.

Lance was right to ask the field of future Presidents how they would attack cancer. Now let's start asking the press to cover the answers and not let them change the subject to pick silly fights.

Greg Simon, President, FasterCures

See You in September…

When Congress comes back in session this September, some heavy lifting is needed to ensure that two agencies vital to advances in biomedical research have adequate resources.

The FDA appropriations process for fiscal year 2008 continues. We appreciate the Senate’s 11% increase above the enacted 2007 budget, and see this as a first step towards a five-year effort to increase the FDA budget. We were happy to see an increase, and hope that the House will accept the Senate number. It is vital that the agency be given more funding, end of story.

Other important work on drug safety will need action in September. The Prescription Drug User Fee Act (PDUFA) reauthorization needs to be addressed since it expires at the end of September. The PDUFA reauthorization contains some key initiatives to move us forward on drug safety and address some of the concerns outlined in the IOM’s report on the topic released almost a year ago. Two areas covered in PDUFA that we are paying close attention to are the FDA Critical Path Initiative which needs more resources, and the proposed Reagan-Udall Foundation which needs to be launched immediately. We believe this Foundation can serve as the research arm of the FDA. There is a wealth of information that resides within the FDA that can be brought to bear on drug safety analysis and drug development issues.

Finally, bills for NIH appropriations will also be considered when Congress returns to session in September. The House and Senate numbers offer slight increases, and there is great concern that NIH will continue cost-cutting if more funds aren’t appropriated.

We certainly need to continue investing in medical research now, in order to accelerate medical solutions for later.

Margaret Anderson, COO, FasterCures

What Has Five Hats and a Hundred Thousand Hands?

So I’m with my family and 50,000 of our closest friends at the Live Earth concert near New York City when these five college aged guys with backward hats start whooping and hollering like they had found gold or were giving birth to those little creatures in Alien. I was hesitant to turn around and inquire “Are you ok? Have you been invaded?” Soon I noticed that the noise level was way beyond five guys, in fact it had started to spread in a pattern. Great, I thought, we’re all being invaded.

Soon the noise was way away from us and we could see it and it was…The Wave…

Let’s just say those five guys were pretty proud of themselves for moving 50,000 people to follow their lead. Five hats moved 100,000 hands. Go figure. We understand that challenge at FasterCures. We have been trying to move a $100 billion research enterprise in this country on a budget of only a few million dollars a year. Now, with our grant from Sumner Redstone of $35 million, we have a chance to start a real wave. But, it is still a huge challenge for even $35 million to move $100 billion. And, that is why we are gathering our “five hats” -- smart friends and advisors to help us determine how to create a wave that will move $100 billion to accelerate the discovery of cures. Seems impossible, but then again…I was at a concert the other day and there were these five guys with backward hats…

Greg

The FDA and You

You might be shocked to hear that the Superintendent of the Montgomery County schools has a budget akin to what FDA Commissioner von Eschenbach has to run an agency that regulates a whopping 25% of American consumer spending. Think about how you use FDA-regulated products each day -- when shampooing, brushing our teeth, taking aspirin or prescription drugs, applying makeup, putting on sunscreen, talking on a cell phone, cooking food in a microwave, and even watching TV. It starts to seem like there is little in our daily lives that isn't affected.

In recent weeks, I've been participating in hill visits with the FDA Alliance (I also sit on their Board) to talk to Congressional staff about FDA's resources. We've been making headway to increase awareness about the need for increased appropriations for FDA. We have yet to meet with anyone who disagrees with the argument that the agency needs more money. How much of an increase we'll see remains to be seen, but the next few weeks will be critical.

The FDA budget has been going backwards not forwards because of inflation, increasing costs, expanded missions, and scientific advancement. The current budget levels are far from adequate. We're asking for $2 billion for fiscal year 2008 (plus user fees on top of that).

I think we'd all agree we look to the FDA to be at the ready as scientific innovation flows through the pipeline. Otherwise what's the point of investing in innovation in the first place? We're expecting cures, and we'd like them sooner than later. The agency needs to be a cutting-edge regulator, one that is a "Gold Standard" worldwide. We need to be maximizing the potential of things like large datasets of electronic health records. This will aid in monitoring drug safety.

The list of things that FDA staff are thinking about now is no doubt long, but they can't scratch the surface without adequate funding. We are all either patients now, or will be one at some point. We need a strong and robust FDA. The 111 members of the FDA Alliance representing consumers, patients, professional societies, and industry all uniformly agree on that point. Increasing FDA's budget is a win-win for public health and the economy. Wouldn't you agree?

Margaret Anderson, COO, FasterCures

Working For You?

I had all of 4 minutes on CNBC this week – which I shared with Merrill Goozner -- to answer the question, “Should the FDA be speeding cancer drugs to market?” What a question.

Answer: YES -- if they work, NO -- if they don’t! (Merrill agreed. that left 3 minutes of dead space.)

But there’s the rub. What does it mean for a drug to “work?” Is extending life three months at a cost of ten to twenty thousand dollars per patient “working?” Is a drug that has a 92% chance of not being a placebo effect “working” compared to a drug that has a 95% chance?

This issue came to a head at the recent meeting of the American Society of Clinical Oncologists – otherwise known as “cancer doctors.” According to the New York Times, several people who had spoken out against a particular cancer drug received threats, even death threats. Apparently some patients felt they had the right to have this drug approved as a last resort even if many scientists felt it did not “work.” And if those scientists didn’t support “saving their lives”, these angry patients felt comfortable threatening them. This is an example of a system that is not working.

Or rather, the system is working just as we set it up to work. We have a $100 billion research enterprise feeding products into a $1 billion drug review system, funded to an ever growing degree by industry user fees. At the front end, we have some pretty strict rules for what constitutes “working.” And anything less than a high “non-randomness” score (i.e. 95% chance of not being random) won’t “work.” Try telling that to terminally ill patients who want to take a drug that has a score of 90 or 85.

Meanwhile, those user fees have been restricted for years from being applied to post market surveillance of newly approved drugs. If you can’t do post market surveillance, you don’t know how a drug is working in the real world until someone reviews random adverse event reports from doctors and starts comparing them to previously obtained clinical trial data that may or may not have tested for the reported effect. And then when deadly effects are discovered in some people, all hell breaks loose because nobody was monitoring whether the drug “worked.”

Avandia. Vioxx. Accutane. Thalidomide. All these drugs work for some people in some very important ways. For other people, they don’t just not work, they’re deadly. Until we have a system that works, it will be hard to tell whether the drugs are working ….or wasting both money …and lives.

Greg