Latest Drugwonks' Blog
I recently had the privilege of discussing the future of drug development with CMPI advisory council member, Joseph A. DiMasi, PhD, Director of Economic Analysis Tufts Center for the Study of Drug Development, Tufts University.
Here are some tidbits you may find of interest —
Q: How will 21st century science help advance the future of drug development?
A: There are hopeful signs that new technologies and analytical approaches will improve the pharmaceutical R&D process in the 21st century. If successful, they will reduce costs and facilitate getting the right drugs to the right people at the right time. There is a growing recognition that genetic and other biomarkers that predict efficacy and toxicity responses or measure disease progression need to be developed, validated, standardized and included in drug development programs. The resulting increase in predictive power can eventually permit smaller and more informative clinical trials. Sharing of blinded clinical outcomes data from failed as well as successful trials across companies can also improve the efficiency of the clinical development process. Bioinformatics, data mining, and Bayesian statistical analysis can also help. Given the high costs of investigating the numerous drugs that eventually fail in testing, advances in discovery and preclinical development technologies that result in a higher hit rate for successful drugs can substantially reduce development costs.
Q: Will these advances impact cost?
A: All of the above technologies and techniques can lower the overall cost of drug development. It is hard to know how much they will do so, but reductions of one-quarter or one-third in average costs seem attainable from increases in success rates or reductions in development times.
Q: What can the FDA do to facilitate these improvements?
A: There is much that the FDA can do, in conjunction with industry, academia, and other government agencies, to modernize the development and regulation of new medicines. These include collaborations to develop and validate biomarkers, facilitating the analysis of pooled data on outcomes across clinical trials, developing guidance on how pharmacogenetic data can be used in labeling, how to utilize outcomes data from post-marketing drug surveillance, where and when it is appropriate to use Bayesian analysis and observational studies, and the evaluation of and standards for electronic medical records submissions.
Sound familiar?
As we’ve discussed before — how about a standing FDA advisory committee on communications issues? See attached article from this week’s Pink Sheet.
It’s not a “stop-the-presses” moment, in truth it’s kind of a “duh,” but here’s a story that crossed the wires today that speaks to, among other things, the power of the FDA’s bully pulpit.
And here’s to more use of it.
AP — Prescription drug prices soften dramatically even with moderate competition, the Food and Drug Administration said Tuesday in an analysis that shows the arrival in the marketplace of just two generic versions of a brand-name medicine can nearly halve the price consumers pay.
When a brand-name drug faces just one generic competitor, that challenger typically sells for 94 percent of the cost of its branded rival. More competition quickly widens that discount: Once a second generic manufacturer appears, the average price of a generic drug drops to just 52 percent of the brand-name version’s cost per dose, according to the analysis posted on the FDA Web site.
Prices continue to tumble, albeit more slowly but almost without exception, as more manufacturers join the market, the analysis shows. By the time nine manufacturers are producing generic versions of a drug, their products typically sell for just 20 percent of the price of the brand-name medicine, according to the federal analysis of 1999-2004 retail sales data on single—ingredient drug products collected by IMS Health Inc.
Jamie Love, who has written and lobbied obsessively about how pharmaceutical IP is the single barrier to making medicines affordable worldwide threw yet another bomb today from his blog at huffingtonpost.com. This time, in a broadside tamely entitled “Terrorism Pfizer-Style” Love accuses Pfizer of killing Filipinos by suing to block the illegal production of a generic version of Norvasc, Pfizer’s top selling blood pressure drug. http://www.huffingtonpost.com/james-love/terrorism-pfizer-style_b_18290.html?view=print
Norvasc is expensive in the Philippines relative to prices in Pakistan and India for example which have robust — and illegal — generic markets. But the wholesale and retail markup on Norvasc in the Philippines is also nearly 100 percent of the manufacturer price according to the WHO, a fact that Love leaves out in his attack. He also ignores the fact that Pfizer offers a 30 percent discount to people who sign up for their discount plan and does not object to a legitimate licensee making a generic version.
Affordability of medicines is a big problem worldwide. But IP is not the main barrier more often than not. Where it is, companies and countries can come together to work out innovative solutions that protect innovation and limit piracy. Most essential drugs are already generic. Markups, taxes and tariffs matter. And getting medicines to people even when they are free (as inthe case of measles and TB drugs) is often difficult even when the governments are not corrupt or engaged in war. For Love to call Pfizer a terrorist reflects immaturity at the least. At the worst, it reflects a lack of sensitivity to those Filipinos that have been slaughtered by the Abu Sayyaf Group and other militant Islamic groups. Such statements, along with the willingness to ignore all the facts, are yet more reasons to not afford Jamie Love the credibility he constantly craves.
Uwe Reinhardt is the smartest health care policy expert in the history of the world…just ask Reinhardt and he will tell you so in 5000 words or more. It could be that he is confusing the the fact that he is a speed dial holdover of journalists from the Clntoncare debacle (when the Clintonistas disrespected his genuis to the point that he was good for a quote a minute about how stupid Bill, Hllary and Ira Magaziner were) with being the light unto generations, but who am I to argue? His most recent target of contempt is Al Hubbard, the president’s point man on health care who is pushing an effort to make the price of hospital and physician services transparent. It’s a good idea and was never offered as a panacea but since Uwe didn’t come up with it, he is defining it as simplistic and stupid.
But it takes one to know one. If you really want to see what Uwe is really like, get a load of his rant on the Physicians for a National Health Plan web site written back in 2001. He calls Americans weak, selfish, stupid, childish, dupes en rouote to venting his frustration as to why they won’t accept rationing and a government run health plan. It is a rambling, hyper screed. I have posted the entire rant because it reveals the Left’s contempt of the American character and its rapid hatred of anything that smacks of free choice.
http://www.pnhp.org/news/2001/august/uwe_reinhardt_commen.php
As discussed in an earlier blog (Bonjour Amigo, 3/27/06) the issue of an informed and empowered patient is at last gaining traction in Europe. Here are some comments from the panelists:
James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General)
* Part of the problem of course is that information and advertising are not mutually exclusive; legislation cannot decide it, although it has to play a role.
Colin Webb (Patient Advocate Representative on the Enterprise & Industry Directorate General)
* We are in this ludicrous situation in Europe, where anyone is free to give information, quite legally, about pharmaceutical products, except the industry which makes them.
James Copping
* Many points made by Peter Pitts about DTCA are important and we can learn from those lessons. As both Peter and Colin said, the focus has to be on communication. The key issue is to think about how we can go forward.
* The member states have all the power in terms of patient information, but often not the resources needed. One key constituency — the industry — conversely has the resources, but not the power to engage. From the Commission’s perspective, there has to be a balance which allows us to put resources, skills and knowledge to good use without threatening the states’ responsibility for health care and control of health systems and pharmaceutical budgets.
* From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.
* We have an unsustainable mix of regulations, focused very heavily on the statutory information, and the legislation on advertising was largely drafted in the 1980s, before the Internet became a daily feature of many people’s lives. This needs to be addressed in the review.
* The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.
Colin Webb
The entire argument is really not whether information should be given to the wider public; generally people agree to this. The question is: who is going to be the gatekeeper?
For a full transcript of the debate, please visit www.cmpi.org
Just to show that we are not joyless wonkmeister’s who download reports on drug development as a leisure activity, I want to let you know that I was a part-time music critic/reviewer a few years back covering what was know as alternative adult or indie performers. One of the best then — and now — is Jennifer Kimball whose musical versatility and lyrical intelligence makes her hard to categorize and mass market. Thus, despite her charm, humor and talent, she never broke out on an established label. But this is a new day. Digital dowloads and emails are creating microchannels and links to devoted fans that in turn create robust markets for performers like Jennifer and her new recording Oh Hear Us. Jennifer has produced the CD under her own label. The title song is my personal slogan for the new Center for Medicine in the Public Interest. (You can’t bring about change without bringing part of yourself along for the ride. We want to be heard because we believe we have a mission not simply a position. ) You can go to cmpi.org to see what I mean and go to http://www.jenniferkimball.com when you what to be both delighted and moved. Go hear Jennifer, in person if you can.
I debated — or rather tried to debate — Families USA’s Ron Pollack yesterday at a Mercatus Center luncheon briefing for congressional staff on whether to lift the ban on price controls in Medicare. Mercatus usually wants the person proposing change — in this case it was Ron since he wants to impose price controls on Medicare drug purchases - but Ron had asked if I could go first since he wanted a chance to eat his chicken wrap, salad and cookies. No problem, since I had eaten a protein bar beforehand.
I tried getting him to explain why he was for a drug plan that did not include price controls in 2000 and was opposed to the same kind of plan now. It’s okay to change your mind, after all. Though I asked Ron 7 times during our exchange about his flip-flop he never addressed the issue. The same goes for how he can categorize as negotiations a system that requires biotech and drug companies to give the VA a 24 percent discount below wholesale price or lower or be barred from dealing with Medicare, Medicaid and the Public Health Service is a “neogtiation”. Never explained that either. Like a robot programmed to stick to two messages, insulting my intelligence (I had called him a hypocrite in my American Spectator article so I wasn’t expecting compliments ) or trying to con people into believing that a federal law requiring price discounts and no price increases above the CPI is a negotiation, Ron just ignored my questions.
He took issue with a study by Frank Lichtenberg that demonstrated that for every dollar spent on new drugs to treat a medical condition, Medicare and consumers will save nearly 8 by not using more invasive medical procedures. He thought the conclusions absurd though he never read the paper. Here’s my source and a link to the paper itself: “For the Medicare population, average medical expenditure per condition is 57 percent higher ($1,286 versus $817) than for the entire population. Thus the savings from newer drugs are also somewhat higher. The total prescription drug expenditure per medical condition will increase by about $21,but the reduction in total non-drug spending per condition falls $176, yielding a $155 net reduction. Hospital cost reduction accounts for 58 percent of the savings ($102). Home health care is trimmed $37, and office visits $34.” (http://papers.nber.org/papers/w8996)
Typically, he called the Lichtenberg study, which is in a peer-reviewed economics journal, a “Phrma financed study.” I have no idea if it was or not. In any event, he didn’t take kindly to my pointing out that the substance was more important than who financed it just as his receiving funding from currency wrecker George Soros should not divert attention from his basic message.
I don’t think Ron and I will be having lunch again anytime soon.
Per this morning’s press conference (see blog below), an additional point — PhRMA has stepped up to the plate and hit a solid series of singles with their voluntary guiding principles. It’s time for the FDA to step out of the batter’s box and take a few swings.
Remember in the not-too-recent past many blustering elected officials regularly called the threat of counterfeit prescription medicines a “ploy” by the pharmaceutical industry? Well, they ain’t bloviating these days. Consider this frightening piece of news that has just crossed the wire …
DETROIT — The U.S. Attorney’s Office today indicted 18 people it alleged took part in a multimillion-dollar international conspiracy to smuggle cigarettes and counterfeit Viagra to raise money for the Mideast terrorist group Hezbollah.
“The enterprise operated from Lebanon, Canada, Brazil, Paraguay, China, North Carolina, Florida and the Dearborn, Michigan area, perpetrating crimes in the states of Michigan, California, Florida, Georgia, Illinois, North Carolina and West Virginia (and points in between),” the indictment alleges.
Unfortunately this is part of a dangerous global trend. The EU recently went on the record (again) with its concern about the rise of counterfeit drugs in Europe (see 3/28 drugwonks.com blog entry) and Canadian authorities reported that they have made arrests in their on-going “Project Piranha,” seizing a Hell’s Angels gang’s supply of marijuana, hashish — and counterfeit prescription drugs (see 3/25 drugwonks.com blog entry).
When, two years ago, the FDA stated publicly that counterfeit drug schemes were being used to fund global terrorist organizations, certain governors and members of Congress accused the agency of “being in the pocket of Big Pharma.” Well, they are strangely silent today.
And I don’t believe in coincidences.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
