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I’ve just returned from the Third International Conference for Improving Use of Medicines (ICIUM). The meeting was held in Antalya, Turkey – not that there was any Thanksgiving-related iconography.
The first thing to remember is that in the world of NGO healthcare policy, “international” means “non-Western.”
There were quite a lot of government officials from Africa, Asia, the Middle East, and a dusting of officials from the US (mostly USAID) and the EU.
The third ICIUM, for the first time, included members of the innovator pharmaceutical industry. They were not asked to wear yellow stars. Noticeable by their absence were any generics manufacturers.
Not surprisingly, most of the ICIUM participants fall into the category of old familiar faces, although there were some noticeable by their absence – like Jamie Love. Well, absence makes the heart grow fonder.
It was an acronym-heavy event, with the most commonly used abbreviation being “RUM” for “Rational Use of Medicine.” (And remember, you can’t spell “rational” without R-A-T-I-O-N.) The other acronym of note was LMIC (“Lower/Middle Income Countries) also referred to as “indexed countries” (IC).
Every day brought a slew of interesting commentary. For those of you unable to make the voyage, some selected tidbits:
Kathleen Anne Holloway (WHO) raised the issue of the deleterious impact of competition among NGOs (as well as the WHO) for project funding. She was blunt about the negative consequences of “competition for prestige, attention, and priorities.” Those negative consequences, it turns out, result in less funding for some WHO projects. Not that the majority of the audience gives marketplace competition any credence – although it’s surprising such incredulity also seems to extend to the marketplace of ideas.
Klaus Leisinger (Novartis Foundation for Sustainable Development) spoke about the need for everyone engaged in the international debate over the improved use of medicines to stop stereotyping each other. (Amen. It’s about time we fought to put the “civil” back in “civil society.”) He then called for the creation of a “grand coalition” think tank to address the opportunities that working together might offer. Klaus – sign me up.
Richard Laing (WHO), after praising GSK CEO Andrew Witty for his company’s devotion to corporate social responsibility, offered that “There is often an unfortunate disconnect between pharma HQs and their marketing departments when it comes to the issue of access to medicines.” Is a word to the wise sufficient?
(Remember -- A Word to the Wise was a 1770 play by the Irish writer Hugh Kelly. His first work was the 1767 hit False Delicacy.)
Dr. Laing also acknowledged the absence of both national and global generics companies from the ICIUM event -- a rather gaping hole that needs to be filled next time around. This issue came up again and again as panelists pointed out (again and again) that in many markets the prices of both branded and non-branded generics are actually higher than (off-patent) innovator medicines.
The role of generics cannot be overlooked considering that something on the order of 98-99% of all medicines on the WHO’s Essential Drug List were either never patented of their patents have long since expired in the IC countries. That being the case, there must be other reasons (beyond the traditional whipping boy of intellectual property rights) to explain why millions of people do not enjoy regular and reliable access to life-saving medicines.
Eva Ombaka (identified only as “formerly of the Tanzanian Ecumenical Pharmaceutical Network”) suggested that pharmaceutical companies should redirect their spending on “inappropriate marketing” to the public health dissemination of “access to medicine information.”
Note to Big Pharma – please refocus all “inappropriate marketing” line items to this effort.
Batool Jaffer Suleiman (Oman Ministry of Health) said that, when it comes to promoting RUM programs, government should “be seen as a support rather than the police.” Indeed. But support for whom and for what? Price or patients? She also shared that her office publishes a regular RUM newsletter called “Pharmaco-Logical.” Who said Omanis don’t have a sense of humor?
Jing Sun (China National Health Development Research Center, Ministry of Health, China) offered an excellent presentation on her nation’s nascent healthcare reform efforts. Her complete presentation will shortly be available on the ICIUM website, http://www.inrud.org/ICIUM/ICIUM-2011.cfm.
She noted that China currently spends 5.14% of GDP on healthcare and (of that 5.14%) 44.5% is spent on pharmaceuticals (about 2.5% of total GDP). When you compare this to the roughly 17% of GDP spent on healthcare by most western nations (with roughly 12% directed towards medicines), there should be some questions asked. And the first one should be; is the higher Chinese percent spend on pharmaceuticals a good thing or a bad thing?
Time and again, speakers from the LMICs noted that their spending on pharmaceuticals was regularly in the 30-40 percent range of their annual healthcare expenditures (i.e., Jordan with 10% of GDP spent on healthcare and 34% of that amount on medicines). Considering that product costs for index nations are significantly lower than western prices, perhaps the higher LMIC spend on pharmaceuticals is because medicines are something these nations can offer their populations – making up for a dearth of spending on the medical professionals and hospitals they do not have – but which represent the lion’s share of western healthcare spending.
In this respect, the high percentage of spending on modern medicines is akin to the LMIC telecom leap-frogging that has created a much higher penetration of mobile phones per capita than in the West. Something to think about.
Another question to ponder is to what extent government interventions may account for higher medicine prices in LMICs. Many governments implement aggressive protectionist policies that allow local generics companies to charge higher prices for products that are off patent – paying too much for older medicines that should be available to patients at commodity prices.
Saul Walker (Department for International Development, United Kingdom) bemoaned the unfortunate and counterproductive tension between “sustainability and innovation.” He also pointed out, with great honesty, that “government is not a unified entity” when it comes to developing and implementing healthcare policy. (He was directing his comments at the LMICs – but it’s equally true across the board and around the globe.) He also mentioned “Big P and Small P” battles being fought both within governments and NGOs. And the P (in case you haven’t guessed) stands for “politics.” Perhaps a panel at the next ICIUM can focus on a new definition of “P value for public health.”
(And, while we’re on the subject of ICIUM IV, there should be a subject track on safety. There was almost no discussion of bioequivalence, GMPs, narrow therapeutic indexing, therapeutic switching, or biosimilars.)
Jonathan Quick (Management Sciences for Health, USA) asked if universal health care was “the golden ring or a Trojan horse?” His answer seemed to be “yes,” concluding that “failure to fully maximize needed expertise” is a major reason that universal healthcare systems are failing. One might also add “failure to understand the realities of market-based economies.” Socialism, as they say, works great until you run out of other people’s money.
Maryam Bigdeli (WHO) made the excellent point that, “Many of today’s problems are because of yesterday’s solutions.” Or as Abraham Lincoln said, “You cannot escape the responsibility of tomorrow by evading it today.”
Danya Qato (Brown University), offering one of the few US-centric presentations, made the excellent point that when it comes to medicines (specifically) and healthcare (more broadly) the barrier isn’t just cost. (Shocking, right?) Her US-based research among a largely Medicare-eligible population demonstrates that racial, social, and geographic disparities play a major role and that “access does not equate to use.” Reality. What a concept.
The other US-based presentation was by Elissa Ladd (MGH Institute of Health Professions). Her talk was on the detailing practices of Big Pharma towards the growing population of nurse-prescribers. (According to Ms. Ladd, there are 150,000 nurse-prescribers in the US, compared with only 100,000 physicians in general practice.) You’ve heard the argument before – pharmaceutical detailing is “bad” because it helps to “sell” products for profit!
She provided no evidence (anecdotal or otherwise) that the information pharmaceutical detailers provide to nurse-prescribers is in any way slanted or anything other than factual and 100% FDA-compliant. Her organization undertook some “educational” efforts that resulted in nurse-prescribers questioning the reliability of pharma-provided information. She positioned this as “success.” But – is having nurse-prescribers (or, for that matter, any prescriber) discount important medical information really a move in the right direction?
And then there’s the Access to Medicine Index (ATMi). The ATMi is an attempt to measure and compare the corporate social responsibility of both innovator (20) and generics (7) companies based on a number of different (and often quixotic) indicators. According the Access to Medicine Foundation, the index “aims to help poor people in developing countries gain access to medicine by encouraging the pharmaceutical industry to improve its commitments and practices related to this issue.” Since it’s a comparison, the theory is that competition amongst companies will drive desirous “socially responsible” behaviors.
A noble goal – but the devil is in the details. Consider subjectivity. For example (and most notably) the index’s four strategic pillars are “commitments, transparency, performance, and innovation.” And its “technical” benchmarks include such vague categories as General Access to Medicines Management, Public Policy and Market Influence, and Capability Advancement in Product Development and Distribution.
As Goran Tomson (Karolinska Institute) pointed out, the index’s methodology cannot be reproduced, hence it cannot be considered statistically valid -- unless you choose to abide the Marxist (Karl not Groucho) maxim that “a special environment creates a special class.”
There are also troubling issues relative to the ATMi’s metrics for success. As the index’s methodological designer, Afshin Mehrpouya (HEC, Paris), opined, the only current measurements are “web hits and media coverage.” Not very exciting, plausible, or helpful from a health policy analysis perspective.
Another ATMi metric is the opinion of patient groups. When asked why certain patient groups were chosen (they are not named in the ATMi), the answer was that groups were chosen based on their “credibility.” In NGO-land that’s code for groups who do not accept funding from the pharmaceutical industry or may not share the anti-private sector bias of the party line. At minimum, that’s a dubious selection bias.
Most damning was Dr, Mehrpouya’s admission that the index, “doesn’t take the patient viewpoint into perspective.
Dr. Tomson also pointed out that the ATMi’s “review committee” consisted almost entirely of “familiar faces,” thus creating an issue of normative bias.
These are all polite ways of saying that the design criterion stacks the deck. But, hey – doesn’t the end justify the means?
What the ATMi has succeeded in doing is getting the attention of innovator companies who want to strut their corporate social responsibility stuff index-wise. The result is that many LMICs are considering the index when making national formulary decisions, thus giving additional points to innovators over generics companies. Some observers at the ICIUM conference viewed this as an unintended negative consequence. But the truth hurts.
To paraphrase Adlai Stevenson, “If NGOs and generics companies will stop telling lies about pharmaceutical innovators, perhaps Big Pharma will stop telling the truth about them.”
One suggestion that came up during the panel debate on the ATMi is to create a parallel index that measures LMICs by whether or not their policies and political environment facilitate or hinder their citizens’ access to healthcare. One such measure, as bravely noted by Jeffrey Kemprecos (Merck), is to measure and address the 800-pound gorilla in the room – the lack of transparency in the public sector and – yes, he dared utter the word -- corruption.
Goran Tomson put the discussion about the ATMi -- as well as the entire ICIUM enterprise -- into perspective when he said the index lacked for “higher ambitions.”
Any maybe that’s the best go-forward message from and for ICIUM – let us strive for “higher ambitions” as colleagues who can (in the words of Klaus Leisinger) “agree to disagree.” Easier said than done. But it’s worth a try.
In other words – let’s talk turkey.
During my tenure at the FDA I served on the agency’s first Counterfeit Drugs Taskforce. Alas, one of the items in our draft report – that criminal penalties for counterfeiting be significantly enhanced – didn’t make it into the final recommendations since it was seen as exceeding the agency’s mandate (and stepping on toes at the Department of Justice).
Well – better late than never. A new bipartisan (and bicameral) effort has been introduced to stiffen the penalties counterfeiters will face for putting illegal and unsafe medicines into the medicine chest of unsuspecting Americans.
The Counterfeit Drug Penalty Enhancement Act will increase penalties for the trafficking of counterfeit drugs to reflect the severity of the crime and the harm to the public. While it is currently illegal to introduce counterfeit drugs into interstate commerce, the penalties are no different than those for the trafficking of other products, such as electronics or clothing. The Counterfeit Drug Penalty Enhancement Act will target violators that knowingly manufacture, sell or traffic counterfeit medicines to the USA.
On the Senate side the bill is sponsored by, Patrick Leahy (D, VT), Chuck Grassley (R, IA), Michael Bennet (D, CO), and Richard Blumenthal (D, CT) and on the House side by Patrick Meehan (R, PA) and Linda Sanchez (D, CA).
Senator Leahy: “While the manufacture and sale of any counterfeit product is a serious crime, counterfeit medication poses a grave danger to public health that warrants a harsher punishment. This legislation will raise those penalties to a level that meets the severity of the offense. Deterring this epidemic problem is a bipartisan effort.”
Senator Grassley: “Counterfeit medicines are some of the most profitable commodities for criminal organizations. Purchases of counterfeit drugs by unsuspecting customers are growing at alarming rates, especially over the internet.” These drugs present a serious threat to the health and safety of people around the world. It’s important we address this threat by imposing harsher penalties on criminals who counterfeit these medicines.”
It’s about time.
Alas Avastin.
Rather than rehashing the debate, let’s just say (1) this decision wasn’t a surprise and (2) it’s a missed opportunity for advancing regulatory science.
Regardless of where you stand on Avastin for HER2-negative metastatic breast cancer – this was a “teaching moment” for the FDA. And the agency missed it.
Specifically, it was an opportunity for the FDA to talk about the future of molecular diagnostics and how it wants to be a partner with industry in their development. Peggy & Co. should have taken the opportunity to go beyond communicating a specific regulatory decision and seized a leadership position on a crucial healthcare policy issue. This is even more disappointing considering the high profile the agency has given recently (and appropriately so) to its Advancing Regulatory Science Initiative (ARSI).
Alas not.
When politics trumps the public health bad things happen. The current conversation surrounding the reauthorization of the Prescription Drug User Fee Act (PDUFA) must focus on (among other things) the First Principle of Predictability as well as ensuring that the FDA can fulfill its role as an important ally in advancing healthcare in America.
Please join the Center for Medicine in the Public Interest (www.cmpi.org) and some of the nation’s top experts in PDUFA and FDA reform for an interactive panel discussion of “Defining the Future of the FDA: PDUFA V and Beyond.”
RSVP to Mario Coluccio: mcoluccio@cmpi.org
DELI LUNCH TO BE SERVED
DATE: Tuesday, November 29th
TIME: 12:00 – 1:30PM
LOCATION: RM. 2168 (Gold Room) Rayburn House Office Building
Peter J. Pitts (Moderator), Former FDA Associate Commissioner, President of the Center for Medicine in the Public Interest
The Honorable Michael C. Burgess, M.D., Vice-Chairman, Subcommittee on Health, U.S. House of Representatives
Vincent J. Ventimiglia, Jr, Former Assistant Secretary for Legislation at the US Department of Health and Human Services, Senior Vice President in the Health and Life Sciences Practice at B&D Consulting, a division of Baker & Daniels LLP.
Paul T. Kim, Former Deputy Staff Director for health policy for Senator Edward M. Kennedy, Partner at Foley Hoag LLP in the Government Strategies practice.
Michele J. Orza, Former Assistant Director of the Health Care Team at the Government Accountability Office, Principal Policy Analyst at the National Health Policy Forum.
Tim Franson, Former Vice President, Global Regulatory Affairs, Eli Lilly & Co., President, USP Convention, Senior Vice President, Health and Life Sciences Sector, B&D Consulting.
RSVP to Mario Coluccio: mcoluccio@cmpi.org
- GRASP spokesman Evan Siegfried
This was in response to the Congresswoman’s comment about Gardasil earlier this week in Iowa, where she told a parent that her daughter shouldn’t “have to live with the ravages of this vaccine.”
Plan Would Delay Sales of Generic for Lipitor
By DUFF WILSON
"The biggest introduction of a generic drug in pharmaceutical history is being met with tough business strategies by Pfizer and pharmacy benefit companies, according to recent letters to pharmacists.
Many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins.
Medco Health Solutions, among the nation’s largest pharmacy benefit managers, is one of the companies issuing instructions, seeking to have pharmacists keep filling prescriptions with the more expensive Lipitor for six months."
http://www.nytimes.com/2011/11/12/health/plan-would-delay-sales-of-generic-for-lipitor.html?_r=2
Except that it won't be more expensive to consumers...
"Pfizer has agreed to large discounts for benefit managers that block the use of generic versions of Lipitor, according to a letter from Catalyst Rx, a benefit manager for 18 million people in the United States. The letters have not previously been made public.
A pharmacy group and an independent expert say the tactic will benefit Pfizer and benefit managers at the expense of employers and taxpayers, who may end up paying more than they should for the drug.
Pharmacy benefit managers are middlemen between drug companies (the sellers) and insurers and employers that sponsor insurance plans (the buyers). "
Let's presume Wilson's unsupported assertion that employers and taxpayers will pay more is correct even though it isn't since PBMs benefit whether the price drops due to discounts or generic drug introduction. Should patients who are on Lipitor be forced to instantly switch to a generic version? Did Duff consider the impact of drug switching to save money in the short term on the ability to reach optimal lipid levels?
No. And he should have. An across the board switch can and does affect compliance. And in the short term at least a percentage of patients (of all ages) saw their bad cholesterol levels increase. Switching from high-efficacy lipid-lowering therapies to simvastatin and low-density lipoprotein cholesterol goal attainment in coronary heart disease/coronary heart disease-equivalent patients. Tunceli K, Sajjan SG, Ramey DR, Neff DR, Tershakovec AM, Hu XH, Tomassini JE, Foody JM. J Clin Lipidol. 2010 Nov-Dec;4(6):491-500
How many strokes and heart attacks occured as a result? Duff doesn't care.
I am not making a case against using generic drugs or even switching. Rather, I am asking why the NY Times and every other major media outlet never considers the impact on price-driven changes on the total health or cost of care. Switching has to be done carefully and has to be explained to patients that equivalent generic drugs are generally as safe and as effective as the innovator product. So a six month transition process, paid for by Pfizer and PBMs is not sticking it the taxpayer. It could be smart and patient-centered medicine.
Does Duff understand that?
In the case of the Commerce Clause and whether the government can compel people to purchase health insurance the Court is, following the reasoning of Judge Silberman, The Court will look at " four factors in determining whether legislation represents a valid effort to use the Commerce Clause power to regulate activities that substantially affect interstate commerce. I am paraphrasing from the Supreme Court decision to invalidate the Gun-Free School Zones Act of 1990 on the grounds is exceeded the authority of Congress to regulate under the Commerce Clause:
Whether the activity was non-economic as opposed to economic activity; previous cases involved economic activity.
Whether the purchase of insurance is an interstate commerce activity
Whether there had been Congressional findings of an economic link between not purchasing insurance, the economy and/health care costs at any point in time
Whether there is a link between regulated activity or inactivity and interstate commerce. http://en.wikipedia.org/wiki/United_States_v._Lopez
The third factor is the one that Silberman focused on. And like other judges who did so they bought the argument that without a mandate people who didn't have insurance would add costs to the system at some point and therefore not buying coverage is, broadly defined, an economy activity. However, one aspect of the Lopez case not always considered in current discussions. The Court of Appeals that ruled the Gun Free Act unconstitutional found the findings and evidence presented before Congress to justify the passage of the Act pursuant to the federal Commerce Clause power was simply insufficient to uphold the Act. http://en.wikipedia.org/wiki/United_States_v._Lopez#cite_note-9
I don't know if the states bringing suit against the federal government have raised or will raise this argument. I don't know if doing so is a plausible legal strategy. But it would seem pretty easy to poke holes in the claim that the lack of a mandate is responsible for rising health care costs and to argue that the findings and evidence presented by Congress are not enough to support the health care law.
It's probably a point worth pursuing for the following reason: I still believe that whatever the Court decides it won't be to the advantage of the proponents of the law and President Obama in particular. If the Court overturns the mandate the administration has made it clear that the rest of the expansion of government power can go on, as well it can. And if the Court upholds the law, it will re-ignite resentment and then some. Whatever happens, Obamacare will become an important campaign issue, as will it's repeal or wholesale revision. That is as it should be.
The Supreme Court said on Monday it would consider the challenge to last year's health care reform law, setting up a major ruling on the Obama administration's signature legislative achievement just months before the presidential election.
The case is likely to be heard in March, meaning that a final decision is likely at the end of the Court’s term, in June.
Apparently in recognition of the complexity of the issues presented by the cases, the Court has asked for an unusual amount of time for oral arguments. The order said the court would listen to five and a half hours of arguments—a rare departure from its usual practice of allocating an hour to hear a case.
The Court has asked lawyers to answer four legal questions about the law in their briefs, signaling that it will issue rulings on each of them.
Read more here.
The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) proposed by Senator Kay Hagen (D,NC) would create two new FDA approval pathways. Drugs would be eligible for "progressive" or "exceptional" approval if they provide meaningful advances in the treatment of an unmet serious or life threatening condition. FDA could also approve drugs based on approval in the EU as well as in Australia, Canada and some other countries.
TREAT would permit progressive approval based on data "reasonably likely" to predict clinical benefit, the standard currently used for accelerated approval. Unlike accelerated approval, drugs could receive progressive approval without data from a surrogate endpoint. Exceptional approval could be granted when the data necessary to satisfy the standard for approval "cannot ethically, feasibly or practicably be generated." would also relax conflict of interest restrictions for advisory committee members, create a fixed term for the FDA commissioner, and revise FDA's mission statement to emphasize the promotion of biomedical innovation.
The draft bill can be found here.
http://washingtonexaminer.com/opinion/columnists/2011/11/david-salzmans-valiant-fight-what-truly-matters
David Salzman's valiant fight for what truly matters
By: Diana Furchtgott-Roth | 11/10/11 8:05 PM
It was December 2006, just before Christmas, when my friend David Salzman called. "I have bile duct cancer, and they've given me only three months to live."
That was almost five years ago. At 1 am on Saturday morning, David, age 53, a Maryland entrepreneur, succumbed to an infection, dying at Johns Hopkins Hospital in Baltimore, with his mother, Nancy Salzman, next to him.
He was one of the longest-surviving patients with bile duct cancer. As well as his mother, he leaves his wife, Beth Kevles; two children, Michael, 16, and Joel, 14; and his brothers, Andy and Jimmy.
For David, our health insurance system worked. As an entrepreneur, he had small-business insurance through Blue Cross Blue Shield. It didn't drop him and never questioned his care. David had only praise for Blue Cross.
I met David in Washington, D.C., in 1986. With two degrees in physics, a B.S. from Yale and a Ph.D, from the University of Chicago, he could have taken the usual academic route. Instead, he founded startups to develop new products.
One of his first companies was Polychip, where he pioneered proximity chip-to-chip communication, which dramatically increases the data rate between chips by stacking them on top of each other.
David sold that patent to Sun Microsystems, later bought by Oracle, which now has a government contract using the technology to develop a new generation of supercomputers.
Another of his companies, LightSpin Technologies, uses new ways to manipulate, detect, and generate light. When David died, he was developing ways to use light waves to find land mines. He considered this vital because of the danger posed by hidden mines.
One of his partners, Eric Harmon, told me, "You shake the ground with a loud noise, and then use the pattern of the sound waves to find the land mines."
Right until his death, David was active in community meetings about the new Montgomery County rail line, the Purple Line. He was intensely concerned with the way politics were overcoming science, and showed how studies justifying the project were artificially inflating ridership and energy savings and minimizing the noise levels.
David was more than just a scientist, he was a modern Renaissance man, able to enjoy literature, opera, and politics with equal knowledge and gusto. That's why my husband and I asked him to be the godfather to our third son, Godfrey, hoping a little magic would rub off.
"There wasn't anything that could be learned that David didn't want to learn," his mother told me on Wednesday.
This extended to his cancer treatments. David's college buddy, Phil Schiff, organized a team of friends to drive David to Hopkins for his weekly treatments so that Beth could spend more time with the boys. I was honored to be on the team.
At the hospital, David would go over the printouts of the blood tests, questioning the nurses and technicians. He chose the most aggressive treatments possible, overcoming pain and side effects, anything to have more time with his family.
Thoughts of his family spurred him on. David kept going by trying to survive until specific events such as Michael's bar mitzvah, Joel's bar mitzvah, and then, the final goal, Michael's 16th birthday on Sept. 23.
Beth told me on Thursday, "David did not want to be remembered for his cancer. Cancer was what he had, not what he was." On the drives to Hopkins we'd talk not about cancer treatments, but about how our various children were doing in school and what they would do over the summer.
Because, in the end, that's what matters.
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.
