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DrugWonks
Drugwonks.com is the web log of the Center for Medicine in the Public Interest (CMPI), a forum offering rigorous and compelling research on the most critical issues affecting current drug policy.
Bloggers!Latest News!Written By Comment Count Comment Last Three July 03, 2009
Peter Pitts
Did you watch the President on ABC talking about healthcare reform last week? Don’t worry – neither did anyone else.
For the best recap, have a look at what Tobin Harshaw wrote in the New York Times' “Opinionater” column: “It was a bit like planning the dream wedding only to have a hurricane rip away the chapel roof as you make your way down the aisle.” He also offers useful links to what other reformacenti had to say: Jeff Poor of the Business and Media Institute gives a “thoughtful, respectful and probing” analysis: “Call this a teachable moment, but even with ABC’s best-laid plans to kickstart the debate about health care reform and not allow the “Prescription for America” special to become an “infomercial,” as many have complained – the president spent more than twice as much time as his questioners vaguely answering or not answering the questions asked of him. But the network consistently presented the event as part of the need to fix a “broken system.” When asked, every one of the 164 hand-picked audience members said they felt that health care needed to be changed.” And further … “While Obama had to field some difficult questions — from the audience and ABC — he faced no Republican critics of his proposals. The network also allowed him to dominate the program with long-winded and vague answers. Out of the 75 minutes the network dedicated over the two programs (commercials excluded), the president managed to take 60 percent of that time: 45 minutes to give 19 vague responses – not exactly the “dialogue” advertised by ABC …” Scarecrow at FireDogLake’s Oxdown Gazette, however, thinks the network lured the president into a devilish trap: “For its part, ABC insisted on having Charles Gibson and Diane Sawyer, instead of informed, qualified health care experts, guide the conversation. That was a mistake, but not the worst of ABC’s offensive conduct. Sawyer’s main contribution was to introduce her own uninformed biases/opinions in framing issues and introducing questioners. Gibson’s primary role was to reveal his own misconceptions and then literally read talking points from a Republican letter — an obvious ransom extracted after days of Republican whining about giving the President air time on a critical public issue.” And as far as trading "Good Morning America" for "Healthcare at Night" ... “Gibson’s other role was to interrupt the President every few minutes to announce a commercial break. The all too frequent commercial interruptions served as an apt metaphor for how private commercial interests demand our attention and extract their profits while limiting our ability to discuss critical public policy issues.” Harshaw’s full column can be found here. -
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July 02, 2009
Dr. Robert Goldberg
Then there is this....just the sort of comparative effectiveness research the media and pols love to run with....
Cost-Effectiveness of Cancer Drugs Is QuestionRead Wall Street Journal article here"The widespread use of expensive cancer drugs to prolong patients’ lives by just weeks or months was called into question by an article published Monday in the Journal of the National Cancer Institute. Crunching data from published studies, the authors found that treating a lung-cancer patient with Erbitux, a drug that costs $80,000 for an 18-week regimen, prolongs survival by only 1.2 months. Based on that estimate, extending the lives of the 550,000 Americans who die of cancer annually by one year would then cost $440 billion, they extrapolated." "How to control escalating spending on end-of-life care is one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system. Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S." -
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July 02, 2009
Dr. Robert Goldberg
Very good language in both regarding personalized medicine and patient-level data. Especially the Federal Coordinating Council report. Less so the IOM panel which was filled (with a couple of exceptions) with underachievers and people who were likely to benefit from preserving the status quo. The devil will be in how the dough is doled out for research and how the results are applied when it comes to reimbursing for new technologies in Medicare, Medicaid, VA, etc.
From the IOM report: "This focus of CER reflects the growing potential for individualized and predictive medicine—based on advances in genomics, systems biology, and other biomedical sciences—through the analysis of subgroups with demographic, ethnic, physiologic, and genetic characteristics that could be useful factors in clinical decisions." Then there is this: "A common misapprehension is that CER will lead to uniform, “one-size-fits-all” care that ignores the ways that patients differ. In fact, CER done well should give providers the means to tailor the choice of treatment to the individual patient’s characteristics and preferences. Better comparative effectiveness studies will make it possible to measure the implications of individual differences in disease severity and the presence of comorbidities, to identify predictors of response to treatment, and to incorporate other aspects of a person’s health and preferences. For example, CER might assess the added value of using genomic information in addition to traditional clinical predictors to determine the best treatment for a cancer in a particular patient." There is no misapprehension. The fact is CER has used data from medical claims and randomized trials to compare drug A to drug B to figure out -- on average -- which one provides the most "benefit" for the least amount of money. And CMS is stil proposing such studies today. Moreover, CER is still framed as head to head comparisons conducted largely through randomized clinical trials that take forever and are biased by the cost contaiment goals of government and by definition exclude patient variation as opposed to continuous feedback loop for improving clinical practice. Read more here -
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July 02, 2009
Dr. Robert Goldberg
My letter to the editor of The Hill is a start.... The fact that there have been fewer patent challenges to biologics than for pharmaceuticals is not a rationale for weakening patent protection for biologics..... Is that the new standard for economic and science policy for the Obama administration? Or is it all about cost? Eshoo drug legislation better than Waxman alternative bill By Robert Goldberg, Ph.D., co-founder, Center for Medicine in the Public Interest Posted: 06/30/09 An important part of the healthcare debate is the two competing pieces of House legislation that give the Food and Drug Administration the authority to create modernized pathways for the creation of generic forms of biologic medicine drugs. Known as follow-on biologics, or biosimilars, the FDA currently cannot approve these important medicines because of safety concerns over the difficulty in replicating these types of drugs. House Energy and Commerce Committee Chairman Henry Waxman (D-Calif.) believes the language in his follow-on biologic bill should be included in the broader healthcare legislation in order to reduce the cost of one of President Obama’s top policy agenda items. On the other hand, Rep. Anna Eshoo (D-Calif.) believes her legislation should go through the standard process of committee markup and onto the House floor on its own, allowing for full vetting and debate on one of the key healthcare reforms of this generation. Both pieces of legislation have their merits and both members should be commended for their willingness to take a lead on this important issue, but Eshoo’s bill has the right prescription for getting follow-on biologics to the market. First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines. Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments. Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases. Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering. Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most. -
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July 02, 2009
Peter Pitts
Suffering from the seven-year itch?
Consider what Steve Usdin of BioCentury has to say on the subject of biosimilars in the wake of the recent Federal Trade Commission (FTC) report. -
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July 01, 2009
Dr. Robert Goldberg
![]() ![]() Samson, my yellow labrador and constant companion for 14 years, passed away this morning. Just wanted to share a couple of photos and one of my favorite poems to let everyone know who he was and what he meant... The House Dog's Grave (Haig, an English bulldog)I've changed my ways a little; I cannot now Fred Goodwin
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June 30, 2009
Caroline Patton
It is presently in vogue to blame most any problem or set back on health care costs. And why not? After all, telling Americans that they are one illness from being bankrupted and landing on the street is an effective strategy for getting them to support your solution. A couple weeks ago, I explained in depth why you should not trust statistics that claim that more than 62 percent of bankruptcies in the US are medically linked. But there is another statistic that is popping up here and there, that 1.5 million Americans will lose homes this year due to medical costs. This number comes from an article by Christopher Tarver Robertson, Richard Egelhof and Michael Hoke published last year. You shouldn’t be surprised that the authors thank Elizabeth Warren, one of the authors of the flawed studies on bankruptcy and medical bills, because they have made precisely the same mistakes. First, the authors report that 49 percent of the people surveyed, all of whom were on the brink of foreclosure, said that the situation “was caused in part by a medical problem” (emphasis original). Of this group, 32 percent cited illness or injuries, 23 percent pointed to high health care costs, 27 percent indicated time off from work, and 14 percent mentioned time spent taking care of someone else in their family. The authors then add those who meet a host of other criteria to reach a total reported figure of around 7 in 10 foreclosures being caused in part by health care costs. Again a low threshold of medical bills ($2,000) and being out of work for two weeks in the last two years are among the criteria used to classify addition foreclosures as medically linked. To begin with, it is unclear what exactly the first category, “illness or injury,” covers since both the costs and the lost wages that are the financial consequences of ill health are included separately. The $2,000 threshold is far too low to meaningfully measure whether medical bills were a serious contributor, especially in the absence of information about other debts and costs. Nor is this above the average out of pocket health expenses for a typical American family. And, as I have argued before, time spent out of work, whether for one’s own illness or to care for someone else, is not directly linked to the health care system but to larger social policy issues. Second, the study also includes gambling, addiction, birth, and death in at least some of the calculations of which foreclosures are health care related. The health care expenses associated with the latter two belong with other medical costs. The expense of treating the former two could arguably be included as health care costs, although this is debatable, but the money squandered on such habits certainly should not be. Third, the study relies on self-reporting by the home-owners and had a very low response rate (about 7 percent) or 128 responses, creating significant potential for bias or over reporting. Attempts to control for this were inadequate and rather cursory. Finally, the article looks at only four states and then generalizes from them. As in the case of bankruptcies, other studies have shown significantly different results and the authors admit that “most debtors cited one, two, or three other, completely distinct causes of foreclosure.” Given that the people surveyed are those already stretched by multiple debts and expenses, placing blame on medical costs is simply inaccurate in many, many cases. You can read the whole article here. -
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June 30, 2009
Peter Pitts
Ambiguity is a virus. When it comes to social media, the more the FDA says about what is and what is not “in compliance” vis-à-vis social media, the less we seem to understand – and more conservative we become. This is not the right answer.
The right answer is to understand the medium and use it to advance both the public health and specific marketing objectives. The two are not mutually exclusive. Let's take blogs as our example. Blogging is a potent weapon in both the war of ideas and the marketplace of communications. Blogs are wonderful tools when used appropriately. They are pithy, witty, and timely. A wonderful triple play – but counter-intuitive to many pharmaceutical marketing cultures. Brevity is the soul of wit – but not necessarily of medical marketing. The tools of the blogosphere are immediacy, emotion, humor, asperity and acerbity. “Let me ponder the nuances of your argument” is just so 20th century. The best bloggers are both incisive and sassy. Blogs act as message accelerators. While a good Op-Ed is absorbed, a timely blog is injected, main-streamed into the collective consciousness of a variety of interconnected audiences. Good blogs resonate. How can healthcare companies take advantage of this phenomenon? One word – engage. But engage carefully. Legal and regulatory issues abound, but a smart place to start is to spend quality time identifying which blogistas are the most relevant to a product or an issue or a company and then read them every day throughout the day. The best blogs are updated more than once a day. It's hard work, but it's worth it. And, relative to metrics, it isn't the top 10 – it's the right 10. Blogs are the new frontier of pharmaceutical communications. The best bloggers are activist, educated, unpaid, unprompted and uncontrolled. Blogs are real-time focus groups without either the design or permission of the sponsor. Its voyeuristic marketing – wonderfully, terribly, brutally naked in both honesty and utility. The medium is the message. And the message is being regularly trawled by the mainstream media for “what's next.” I blog every day and regularly get calls from “traditional” journalists to discuss what I'm saying and where I think its going. And if your cognitive mapping is having a hard time accepting this proposition – ask Maureen Dowd. -
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June 29, 2009
Peter Pitts
Some interesting tidbits from the FDA’s June 24th meeting on the issue of transparency. “FDA should make it obvious, to those who are interested, how scientific data leads to its approval decisions.” -- PhRMA Assistant General Counsel Jeffrey Francer. As an example, Francer pointed to FDA approval decisions that do not track with advisory committee recommendations. "That's often confusing, not only to those of us in industry, but people generally." Absolutely. But, since transparency cuts both ways, wouldn’t it be equally beneficial for pharmaceutical companies to proactively release complete response letters received from the agency once a final action has been taken? Transparency thrives in an atmosphere of clarity. And that was also a topic of conversation. BIO’s Director for Science and Regulatory Affairs Andrew Emmett, commented that the FDA does not meet and communicate with firms on a consistent basis early in the development and review process. He urged, and appropriately so, that the agency work with industry to minimize barriers to such meetings. Emmett also called for the agency to provide more information so industry can understand how FDA makes decisions. There needs to be "regulatory transparency and clear articulation of FDA's policies and expectations." Since it can take several years for FDA to finalize guidance, "This leaves companies to ascertain FDA policy by interpreting the agency's regulatory decisions and enforcement actions, which is an inefficient way for industry to understand and meet the agency's regulatory expectations." If we’re going to go “open kimono” on this, then the real 800 pound gorilla in the room is the fact that many inside the FDA prefer to leave guidances in draft form – because that ambiguity gives them almost unlimited and perpetual power. That’s why interpretation of FDA actions is such a vibrant cottage industry. Industry, on the other hand, seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA. Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than broad definitions, is a distinctly more challenging proposition, because changed minds must begin with change agents within the agency itself. FDA transparency cannot be achieved without FDA predictability. Predictability is power in pursuit of the public health. On a related note (and at a different venue – the annual DIA meeting in San Diego), Sandy Kweder (Deputy Director, FDA Office of New Drugs) and Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) discussed the need to begin REMS conversations as early as Phase II. Dal Pan commented that "REMS are as new for us] as they are for all of you. It's not that we hold some secret and we're just not telling anybody about it. We're all navigating through this and trying to figure it out.” -
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June 26, 2009
Peter Pitts
Looks like the FDA is getting down to some serious social science According to the Pink Sheet, a study proposed by FDA to evaluate how benefit information is conveyed through direct to consumer advertisements could end up showing drug marketers how to describe "high" and "low" efficacy drugs. The proposed study will evaluate how consumers' interpretations of a drug's efficacy after viewing DTC ads compare to the efficacy data in the product's label. The study will be conducted in two concurrent parts - one looking at print ads and one at TV ads - and examine three factors: drug efficacy, visual format, and type of statistic. The agency defines drug efficacy as a quantifiable, objective metric that can be conveyed in graphical representations of the drug versus placebo, with "high efficacy" meaning "noticeably better than placebo" and "low efficacy" meaning "minimally better than placebo." The agency traditionally has discouraged companies from making such qualitative claims - or even making too much of quantitative numbers - in its advertising. But the proposed study endpoints suggest a growing FDA comfort with, and even an interest in, consumers receiving this kind of information. Testing Pfizer-like pictographs The study will examine graphs, pictographs and pie charts as ways to visually present that efficacy information, and whether statistical information is best conveyed as frequency, relative frequency, or percentage. The test product will be for a cholesterol treatment and modeled on an actual drug, such as Pfizer's Lipitor (atorvastatin), with labeling used as the reference for defining efficacy levels and the objective metrics for clinical performances. The study will include 4,500 participants, 2,250 in each group (television or print). The subjects will read or view one advertisement version, and then make a series of judgments about the drug in a 20-minute interview. FDA first will test whether, within each format, the participants were able to distinguish between low- and high-efficacy drugs. Then, it will look at whether the participants' efficacy estimates differ across formats and how accurate the estimates are. Comments on the proposed study, called "Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisement for Prescription Drugs," are due by Aug. 21. All to the good. And it sure beats the ignorant "drug facts box" – the a la nutrition facts panel idea,that’s being kept alive via legislation introduced by Senators Jack Reed (D, RI) and Barbara Mikulski, (D, MD) which, BTW, would also require comparative effectiveness information to be included in product labeling. Vey -
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June 26, 2009
Peter Pitts
What's the difference between PhRMA and BIO?
Roche. Roche is leaving the Pharmaceutical Research & Manufacturers of America trade association effective June 30. Roche describes the action as a "business decision" by "the newly combined Genentech-Roche US commercial organization." According to the Pink Sheet, "As a practical matter, the departure will add to the strain on PhRMA for resources as it works on all fronts to build alliances and promote its reform agenda. The pending mergers of Pfizer/Wyeth and Merck/Schering-Plough will further reduce the group's core member base. The association traditionally adjusts dues following periods of consolidation." -
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June 25, 2009
Caroline Patton
From the discussions of how American car companies are put at a disadvantage because they have to pay health insurance costs that firms in other countries avoid, it isn’t surprising that many people have concluded that health care systems in these nations are single payer. In fact, neither Germany nor Japan, two of the countries most commonly cited in this connection are government run or paid. I have already discussed Germany on several occasions, today I want to talk about Japan. The Japanese health care system is rather complicated, with different, somewhat interlinked, plans for citizens depending on their employer and stage of life. Japan’s Employee Health Insurance Program obligates any business with 700 or more people working for it to offer health coverage to its employees. About 85 percent of companies essentially self-insure. For these companies, around 8.5 percent of payroll goes to health care and employee and employers split the cost more or less in half. Around 26 percent of people in Japan fall under this part of the system. Companies with fewer than 700 employees participate in a federal, health insurance scheme for small businesses, run by the state. Approximately 30 percent of Japanese are in this group. Small companies pay about 8.2 percent of payroll and the state then puts in additional money. Those who are self-employed fall under the government’s Citizens Insurance Program. It is managed by municipal rather than national authorities and is paid for by a self-employment tax, taxes on insurance companies and the government plan for small businesses, and, when necessary, direct government contributions. Those who are unemployed retain the coverage they had while working. Finally, the health coverage for the elderly is called Roken and does not have separate financing of its own but is paid for by money from the other three parts of the system and government money. Private health insurance is possible, but rare. In addition to taxes and the percentage of their wages they pay out for health care, people in Japan also have significant co-pays, usually around 30 percent, and other out of pocket costs for medical services. There is a ceiling on co-pays, for a middle class family, it is about $677 a month, and a normal family spends around $2,300 in a year on medical care in addition to what they pay through work. Out of pocket costs amount to about 17 percent of annual medical spending. Japanese hospital and medical facilities are usually privately owned and operated. Small facilities tend to belong to one doctor or family, even those carrying out advanced procedures. Hospitals and doctors in private practice usually get paid a set amount for each treatment or other service and drugs also cost the same throughout the country because the prices are determined by the government. That doesn’t mean that some people haven’t figured out ways to game this system. In some cases, doctors have bribed government officials in charge of setting fees. Doctors also benefit from ordering unnecessary tests and from seeing as many patients as they can in as little time as feasible. As a result, “two-thirds of patients spend less than 10 minutes with their doctor; 18 percent spend less than 3 minutes.” The upside of health coverage in Japan is that it includes almost everything, sometimes reimbursement for travel expenses. Patients can go to any doctor or hospital and usually they do not need a referral or approval from a primary care physician to see a specialist. Technology is highly advanced and very accessible. And, because the cost is the same everywhere, medical facilities compete on the basis of quality or having the latest treatments. Some top hospitals do end up with queues, however, and some people pay illegally to jump to the head of the line. Contrary to the situation elsewhere in the world, many argue that Japan needs to spend more money on health care, which consumed about 8.2 percent of GDP in 2005, less than similar systems in Europe or the US. However, the system is strapped for cash with the costs of care outstripping what is paid in. Further, people in Japan go to the doctor a lot, especially the elderly who pay less out of pocket for their care, whether for minor complaints or just to chat. This is particularly a problem because the elderly account for a staggering 90 percent of the growth in health care costs and are steadily rising in number, producing fear for the future of the system. -
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June 25, 2009
Dr. Robert Goldberg
From an oped by Paul Duncan
"To be sure, if the same public program that competes with the private entities also gets to write and enforce the rules of the competition, that might create a problem. But almost all serious observers anticipate that the public program alternative currently being proposed will not also control the regulatory framework in which services are offered; it will simply be available as another option, and will survive only if it can succeed as a genuine alternative to those private companies. " Read Op-Ed here. Can we say delusional? Let's take a look at how public plans work here and around the world. Do they compete like the postal service (oh sorry, no real competition) or do they set the prices and lowball providers and then just expand budgets in response to demand generated at taxpayer expense without regard to profitability, waste, corruption. Does Medicaid compete? Medicare? How about the Indian Health Service? Further, we already have public options such as Medicaid and SCHIP. What we don't have are more private choices that promote prevention and well-being and that should be the point of reform. Making the government the lowball option is a bait and switch that will eliminate individual choices of health care plans. Why? Government's can tax and spend without the timely accountability that only a private choice based system protects. Aetna's profits declined this year because it lowered prices to gain market share even as it spent more on medical services, disease management and prevention. Reform should encourage more of this and build on such efforts rather than kill them. That's what is at stake. And more. Badtux
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June 25, 2009
Peter Pitts
Just returning from San Diego and the 45th annual Drug Information Association (DIA) conference where I participated on a panel about how to improve FDA communications. It was only 90 minutes long and we didn't solve all of the world's problems -- but there was some forward motion.
The panel was chaired by the always alert Julie Zawisza, CDER's Director of Communications and I was joined on the dais by Ray Kerins (Pfizer) and Steve Usdin (BioCentury). We coverered a lot of ground, but what really was on the mind of the audience was the FDA's stance (or lack of one) on issues related to social media. We talked about DDMAC letters and the risk communications advisory committee, blogging, Facebook, Twitter -- and yes, even Cheerios. And the general consensus was that the agency was behind the curve. I know, duh. But that's when Julie Z. stepped up to the plate with the following comment, "The FDA has no intention to stiffle the use of social media." It might have sounded like a throw-away line -- but if that sentiment is genuine (and Ms. Z, is as genuine as they come), then there's hope for FDA to be both regulator of and partner in using social media to communicate important public health information. In fact, Julie said (twice) that she was going to talk with Janet Woodcock about holding a series of external meetings on the subject of "Web 2.0." She also, aptly, pointed out that when it comes to understanding, regulating, and using social media channels, it's important to understand that "it's not just information, but context and perspective." You go girl. -
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June 24, 2009
Peter Pitts
Venezuela has announced plans to invalidate the patents on a number of medicines and allow local firms to produce cheap generic copies of them, under a reform that would gut the country’s intellectual patent laws.
According to President, Hugo Chavez, “we consider that patents cannot be a restriction or a trap ... An invention or a scientific discovery should be knowledge for the world, especially medicine,” said Chavez, adding: “that a laboratory does not allow us to make a medicine because they have the patent - no, no, no.” The proposals were announced on national television by the Minister of Trade, Eduardo Saman, who told the nation that “patents have become a barrier to production, and we cannot allow barriers to the access of medicine or transnational medicine companies to impose their rights on the Venezuelan people." “We are revising all the doctrines and laws related to patents, which should be compatible with the international treaties that we have signed and respect and honor,” he added. But, there’s always enough money to invest in a vast military. So much for “respect and honor. -
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June 23, 2009
Peter Pitts
Part D, that is.
Last time the prescription drug plan for senior citizens was in the news it was being vilified by many members of the majority party. Some even saw it as an election wedge issue. And then there was the whole Non-Interference Clause thing. And then the politios and pundits saw that Part D was a huge success with America's seniors and coming in well under budget projections. And that was the last we heard of it. Until yesterday. Yesterday's announcement of the $80 million deal not only put Part D back on Page One -- but also introduced a new fan -- President Barack Obama. Now, it seems, we have a President who embraces the program designed to maximize free-market public/private partnerships and provide maximum healthcare choices for program participants. Who'd a thunk it? This plan will also do away with the silly Catch 22 of not being able to include medicines provided via patient assistance programs (PAPs) towards spanning the infamous donut hole -- something that the Bush Administration was not able to do. It's kind of a Nixion-going-to-China thing, although I'm sure the President would wince at such a comparison. Maybe it would be more palatable to say that, when it comes to healthcare reform ... it takes a village. afisher
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June 23, 2009
Peter Pitts
I don’t really want to rain on anyone’s public health parade, but giving the FDA the authority to “regulate” tobacco isn’t that great an idea.
Sorry. And I know how excited everyone is and everything. FDA regulation of tobacco? Bad idea. Really. Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not. One major problem with the legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products. Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. With FDA as the nation's tobacco Tsarcoe Selo it will be difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs. After all, now it’s the FDA’s responsibility. Can you say “FEMA? Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program will be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself -- is that really the way we want to be going. So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one. Sorry about that. Really sorry. -
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June 22, 2009
Caroline Patton
Many Americans’ idea of health care in Europe looks something like Norway. Its health system even has the imprimatur of Michael Moore, who says that although he filmed there as part of his movie Sicko, it did not end up in the final film lest it be found too unbelievable for American viewers. The first thing is that health care in Norway isn’t cheap. Norway spends 8.7 percent of its GDP on health care, less than most of its European neighbors, but this is misleading because with outlays of $4,520 per capita, Norway was the most expensive in Europe on this measure, and the priciest in the OECD other than the US. This cost is funded by central government tax revenues, additional taxes charged by the municipalities, and some out of pocket costs to patients. Contrary to popular belief, the government doesn’t carry out all of the day to day operation of the health care system. Rather, Norway has significant decentralization in providing care. Five regional health authorities oversee access to specialists, while primary care falls under local authorities and these authorities have considerable latitude in their operations. General policy, reimbursement rates, and the annual budget are, however, still set on the federal level. Many doctors and health care workers are paid salaries by the state rather than being reimbursed for the care they provide and The upside of the Norwegian system is that anyone who is a legal resident can participate in the government system. They are entitled to all “necessary health care,” often defined quite inclusively, and neither doctors nor health care officials can deny treatments that fall under this for any reason, even if it creates a financial strain on the system. Some patients are even entitled to spa treatments, paid for by the state. But while being in the hospital costs Norwegians nothing, health care there is not totally free at the point of service. For services not fully covered, patients are charged copays up to an annual individual total, about 1615 kronor in 2006. As an example, a visit to a GP costs about 125 to 235 kronor. Children are not charged copays for all or some medical services, depending on age. Those who are retired or disabled are also exempted. Once a person (or one parent plus children under 16) has reached this threshold, they get a special card and their care is then gratis for the rest of the year. Over 1 million Norwegians reached this point in 2005. For care in areas outside the health system, such as dental and rehabilitation or treatment outside Norway, there is a separate threshold of 2500 kronor, which works the same way. Other costs to patients come from copays for medications, plus having to pay the difference if a patient wants a pricier drug than the system will reimburse for. Overall, around 15 percent of health care spending is out of pocket. The other side of such generosity is that Norway is among the nations whose residents must contend with extensive waits for health care services and rationing of care. This means that it is common for Norwegians to go to other countries to receive care faster than at home. Norway has also fallen prey to the lure of cost-effectiveness, which often comes into conflict with the wide right of Norwegians to “necessary health care.” People in Norway also have only a limited ability to decide which doctor they want to go to since only those listed with the government are acceptable and specialists can only be seen with a referral from the general practitioner. Norwegians can choose their hospital but cannot demand procedures that are not authorized by the doctor. Despite the huge government system in Norway, those who prefer private care can spend their own money to get it. However, private facilities are relatively few and generally located in urban areas. Most Norwegians go private only for “substance abuse treatment, rehabilitation and dental care,” as well as many laboratory tests and scans. Pharmacies are also primarily private. Care outside the government system also is significantly more expensive and generally private policies are purchased to supplement public coverage, not replace it. -
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June 22, 2009
Peter Pitts
I recently participated in the 9th France/USA AGIPHARM Conference. This year’s event was held in
Particle accelerators are, after all, about high-speed collisions. -
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June 22, 2009
Dr. Robert Goldberg
Did you ever think you would see this come to pass...
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