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Latest News!Written By Comment Count Comment Last Three January 28, 2010
Dr. Robert Goldberg
Just a sampling of the desperation and self-confessionial screeds coming from liberal health policy "experts"
Ezra (Moment of the Mind) Klein: That said, many are hoping that the State of the Union was the start, not the end, of Obama's renewed sales pitch. As I write, the president is in Tampa, making many of the same arguments, in much the same way, as he did last night. He sounds like he did on the campaign. He has more events scheduled in the next few weeks. It was a good beginning, say some on the Hill, but that's not enough. http://voices.washingtonpost.com/ezra-klein/2010/01/what_obama_did_and_didnt_say_o.html Jonathan Cohn (giving it the " we just need to explain it more and better excuse") Fortunately, Obama seems to grasp this too. He acknowledged, explicitly and with a sense of humor, his administration's failure to explain the plan--and noted that few people understand exactly what it would do. He also reminded people, in simple terms, of the reasons he took up the challenge. He talked about people suffering because they had no insurance or their insurance was inadequate--and he talked about the economic importance of controlling health care costs. http://www.tnr.com/blogs/the-treatment And my favorite from Senator Baucus “We’re not going to put it down,” Baucus said. “We’re moving expeditiously. And expeditiously means quickly, solidly, thoughtfully.” http://news.yahoo.com/s/politico/32191 -
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January 27, 2010
Dr. Robert Goldberg
Rosner's Domain: The why-Haiti-but-not-Gaza nonsenseWhile Israel is making an effort to save life in Haiti, the never-happy-with-Israel crowd is trying this new line of over-sophisticated counter-intuitive argument: Haiti is easy, but what about Gaza. Here's Derfner saying: "the Haiti side of Israel that makes the Gaza side so inexpressibly tragic. And more and more, the Haiti part of the national character has been dwarfed by the Gaza part". Here's the Electronic Intifada criticizing the media for its positive spin of this humanitarian effort: "A few media outlets have pointed out the discrepancies in Zionist self-congratulation". And the estimable NYT showing very little understanding of Israel's true feelings by claiming that "Israelis have been watching with a range of emotions, as if the Haitian relief effort were a Rorschach test through which the nation examines itself. The left has complained that there is no reason to travel thousands of miles to help those in need - Gaza is an hour away". "Range of emotions" meaning what? that 99% support the effort and 1% complaining about Gaza? That 99% feel proud about this humanitarian effort and 1% feel the need to politicize even the simplest act of compassion and demonstrate, yet again, that they've lost their collective minds? Anyway. Since this the why-Haiti-but-not-Gaza nonsense is gaining traction, maybe some reminders are necessary. Here we go: 1. Because Haitians never bombed Israeli towns. 2. Because the government of Haiti never declared that it wanted Israel to be eliminated. 3. Because no Haitian suicide bomber was caught trying to reach an Israel bus stop of cafe. 4. Because while Gazans' suffering should not be belittled, I don't remember any report claiming that 100,000 Gazans are dead because of Israeli blockade. Not even the Goldstone report. 5. Because it's easier sending rescue workers and doctors in uniform into a place in which Israelis in uniform are well received. 6. Because no Israeli soldier is being kept hostage in Haiti, and there's no standing Haitian demand for the release of hundreds of terrorists from Israeli jails. 7. Because Haiti had no way of stopping the earth-quake and the government of Gaza can easily make life better for its people by changing course. If you're smarter than a fifth grader, I'm sure you can add many more such points. If you're smarter than a fifth grader you know that sometimes being too-smart is being stupid.-
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January 27, 2010
Mario Coluccio
With the AFL-CIO opposing passage of the Senate health bill on account of the “Cadillac tax” and House members increasingly skittish in the wake of Scott Brown’s victory in Massachusetts, it appears unlikely the House of Representatives will pass the bill. That said, it’s worth exploring the motivation behind the so-called Cadillac tax, which is one of the main obstacles to the health bill’s passage in the House. Rep. Jerrold Nadler acknowledged the obvious absurdity of this Cadillac tax concept a couple weeks prior to the deal struck with Big Labor. Nadler said “The fact that premiums are higher does not mean that benefits are better.” Duh. Something far more sinister is at work here. Patricia Murphy at Politics Daily nails it in just two paragraphs: Despite the politically powerful unions that oppose it, the tax is enormously attractive to government economists because it both raises revenue -- $149 billion over 10 years -- and should depress the rate of health care inflation by discouraging companies from offering more generous health plans. The Joint Committee on Taxation and the CBO credit the tax as the largest factor in "bending the cost curve" and cutting the federal deficit, as Senate Democrats say the bill will do. Christina Romer, a senior economic adviser to the president, predicted in October that the tax would encourage "both employers and employees to be more watchful health care consumers." But research released last week by Mercer, an employee benefits consulting firm, showed that in addition to considering lower-cost plans, two-thirds of companies polled said they would also raise health care costs for workers through higher co-pays and deductibles, regardless of whether the employee is a CEO or a line worker at a factory. This is odd as we have been told to the point of exhaustion that insurance companies are shamelessly denying people health care as a matter of course all in the name of profit. But that’s the dirty little secret – these so-called health reformers believe Americans consume far too much medical care. Of course they won’t come right out and say that for political reasons. Instead, they simply rail against insurance companies, the drug companies, and whatever other bogeymen they have created to pollute this debate. This tax on “Cadillac” plans would create the groundwork for a situation whereby we all end up paying substantially more for health care but get appreciably less in services than that which we are accustomed. It’s eerily similar to the Japanese health model. Insurance companies are heavily regulated. The Japanese pay unusually high co-pays, a large chunk of their insurance premiums (employers picking up the rest) and out-of-pocket health expenses for services not covered by the modest insurance plans. This works to ensure more equality of medical treatment – but it’s sub-par treatment. While Japanese patients want American-style treatment, their policymakers are alarmed. With a huge national debt and corporations worried about higher taxes, they say Japan can't afford to pour money into treatments that can't extend life span by very much. "America did too much of this and that's why their medical costs have grown," said Masaharu Nakajima, a surgeon and former director of the Health Bureau at the Ministry of Health, Labor and Welfare. Since Japan enacted universal health insurance in the early 1960s, the emphasis has been on a minimum standard of care for all. People must pay a monthly health-insurance fee, and large companies pay also. Coverage decisions, doctors' pay, and other rules are set by the central government. Japanese doctors complain that they have no time to spend with patients. The experience of seeing a doctor is summarized as "a three-hour wait for a three-minute visit." “Minimum standard of care for all.” Those are the key words. The commitment to "social justice" is driving this idea and not any commitment to sound health policy. It’s hard to believe Americans in 2010 are prepared to give up their Cadillacs in exchange for Pintos. -
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January 27, 2010
Mario Coluccio
Paging Michael Moore… The Washington Post reports on the deaths of 26 mentally-ill patients from hypothermia at one of Cuba’s largest hospitals. The cause? Faulty windows and substandard care. The Post notes: “Communist Cuba provides free health care to all its citizens but, though the quality of its medical system is celebrated in leftist circles around Latin America, it is also plagued by shortages. Patients are expected to bring their own sheets and towels and sometimes their own food during hospital stays.” Not to worry, the benevolent Cuban government has its priorities in order. Cuba revealed last week that it has been lining up folks for sex-change operations at the government’s expense. The Revolution lives! -
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January 27, 2010
Mario Coluccio
While Nebraska has been the target of much criticism and the central focus of the special deals that tainted the process of securing Senate passage of a health care bill, there are other states that received equally insidious protections. A Drugwonks reader recently emailed me in an uproar about President Obama’s home state of Hawaii being on the receiving end of a special deal as well in the Senate bill. Not giving the claim much credence initially, I looked into it and, lo and behold, she was right. The Hawaii Reporter explains the specific exemption in the bill: “H.R. 3590 also includes a provision requested by Senator Akaka which preserves Hawaii’s system of employer-mandated health care. A large percentage of Hawaii residents have health insurance because of the state’s employer-mandated health care system which depends on a long-standing exemption from the Employee Retirement Income Security Act (ERISA). The Patient Protection and Affordable Care Act includes a provision that is intended to preserve Hawaii’s unique ERISA exemption and the employer-mandated insurance that the exemption enables.” Hawaii has a law that mandates employers provide robust health plans to employees who work at least 20 hours a week. It is a law that has been on the books since 1974. The Senate health bill has no such employer mandate. This comment from Honolulu arbitrator and labor lawyer Michael Nauyokas stands out: “We don’t need the feds to go in and mess up our system.” One might argue the state of Massachusetts sent Congress that exact same message last week on behalf of the other 49 states. -
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January 26, 2010
Dr. Robert Goldberg
Something that was ignored throughout the long ponderous, hollow debate over healthcare reform is clearly articulated by Jim Pinkerton:
"Healthcare is a great driver for the economy. It's the biggest employer, and medicine--not "health insurance"--is a product that people want to consume, sometimes desperately, ravenously. And not just Americans, but people around the world. So if that's not an economic engine, what is? Isn't that what we want? But the argument has to be made. And alas, since, 98 percent of the discussion over healthcare has been over controlling costs--that is, shrinking the healthcare sector, perhaps provoking a recession in one of the few vibrant sectors of the economy--then it's little wonder that the country doesn't think of healthcare and medicine as an economic driver. Serious Medicine Strategy has always been an economic strategy--now is the time to make that case." seriousmedicinestrategy.blogspot.com/2010/01/democrats-slam-brakes-on-health-care.html -
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January 25, 2010
Dr. Robert Goldberg
The movie Extraordinary Measures chronicles the story and struggle of John and Aileen Crowley to find a treatment to save the lives of their two children, both of whom have Pompe Disease, an irreversible and rare disorder that prevents the body from breaking down glycogen (a form of sugar). Glycogen accumulates around the heart and skeletal muscles leaving children unable to walk or breathe on their own. I won't provide a movie review here since information about this new release is available everywhere, except to say that Extraordinary Measures is a family movie in two important ways.
First, it is a movie that parents and kids (13 and up in my opinion) can and should see together. It demonstrates the power of love and the determination parents have, even under the most dire circumstances, to provide children with hope and happiness each moment of their life. It shows that you can go up against and use the system to make a difference and that the "system" will invest in that risk and reward it. However the movie shows that making a miracle involves going against the grain, which is why meaningful change or advances take time. And the movie does the best job of explaining the interesection of capital, science, passion and faith the constitutes the process of biomedical innovation. A thoughtful, impactful movie about biotech and drug development? Extraordinary Measures is that and more because it ties the process of innovation to the ultimate purpose and people who benefit. Second, the movie itself is the culmination of a process that has created a family of relatives, friends, supporters around the Crowleys. I was fortunate to have attended a post-movie reception that Geeta Anand, the gifted and gracious author of The Cure held in NYC yesterday. The group that gathered (including the Crowleys) -- including people involved in the movie, Geeta's literary agent (and mine) Joelle Delbourgo, former associates, etc. shared not only in the success of her book but in the spirit the book, the movie and the release of both have created: A sense that while anything may not be possible, nothing great happens without passionate intensity, friendship and cooperation and support of those you love. Such is the recurring source of hope. Seeing the movie and reading The Cure will allow you to share in that experience. Few movies have been made to convey such a message. You read more about Extraodinary Measures and The Cure at the link below. http://www.thecurebook.com/ -
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January 22, 2010
Peter Pitts
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January 21, 2010
Dr. Robert Goldberg
Let the big government types defend comparative effectiveness generated decisions that exclude and undermine the health of minorities... We are supporting a different, more compassionate and equitable approach...
Prospective Health Consortium: Development and Assessment of Predictive Tools in Disease Prevention and Wellness Promotion We are proud to support the launch of a consortium that would develop and evaluate a tool for health risk assessment and treatment selection based on predictive information relatively unique to that individual that can be used to reduce disease and promote wellness in medically underserved communities. The idea of a consortium is based on discussions held in May at Brookings Institution at a meeting entitled “A Critical Path for Personalized Medicine”. That meeting -- chaired by Dr. Mark McClellan and Sir Michael Rawlins -- discussed ways to demonstrate how predictive or personalized medicine could be used to improve the quality of care and health outcomes. In particular, Ralph Snyderman MD, Chancellor Emeritus of Duke University Medical Center and CEO of Proventys, called for an evaluation of an tools bringing together the latest technologies to predict events and enable intervention before damage occurs. Combining personalized risk prediction and strategic health-care planning will facilitate what Snyderman calls ‘prospective health care’. -
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January 21, 2010
Dr. Robert Goldberg
Maggie Mahar -- another liberal health care "expert" -- on why a bipartisan healthcare effort should not be pursued:
"Conservatives blame the sick for being sick, and they fault the poor for being poor. Health care reform must be compassionate, and it must be equitable." Read more here. -
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January 20, 2010
Dr. Robert Goldberg
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January 20, 2010
Peter Pitts
ITP? Not ASAP.
John Dalli, Commissioner-designate for Health and Consumer Policy (SANCO) has pledged new initiatives to break the deadlock on Commission proposals to liberalize controls on the provision of prescription drug information to patients. And we all know how fast Brussels operates. As Pharma Times reports: - In the new European Commission, the move of responsibility for the pharmaceutical industry from the Directorate General (DG) for Industry and Enterprise to DG Health and Consumer Safety (SANCO) has been welcomed by consumer and patient groups. One of the reasons holding back progress on the information directive has been concern that it was drafted by DG Enterprise and Industry - whose responsibilities include regulatory and industrial policy for the pharmaceutical industry – rather than DG Sanco, which is concerned with consumers and public health. While countries including Denmark, Sweden and the UK support the Commission’s proposals, a number of others – including France, Germany and Spain - oppose any move to liberalize controls on the provision of prescription drug information, for reasons including the fact that the draft does not distinguish sufficiently between “information” and “advertising.” They also believe that the industry should have no role in the provision of information to patients and that the proposals would drive up health costs by increasing demand and because of the need to set up monitoring mechanisms. -
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January 20, 2010
Peter Pitts
Don’t think about Scott Brown as the 41st vote against healthcare reform. Consider him the 1st vote towards a new, more thoughtful approach. A more honest approach. An approach that doesn’t require Uncle Sam to become Uncle Sam, MD. An approach that doesn’t tax the middle class, gut Medicare and abolish Medicare Advantage. An approach that doesn’t put the power of government reimbursement decisions into the hands of a politically appointed panel without any oversight by elected officials. Perhaps even an approach that takes into consideration reform via a partnership between government and the private sector (a la Part D). And maybe even an approach that considers allowing Americans to buy insurance policies across state lines so that we can all benefit from a significant economy of scale and radically lower premiums. A study by University of Minnesota shows that Congress could boost by more than 12 million the number of people who have health insurance without spending taxpayer dollars. The change required is to allow people to buy health insurance across state lines, so they can shop for less expensive policies. For example, a typical health-insurance policy in heavily regulated New York costs more than three times as much as in less regulated Iowa ($388 a month versus $98 a month for the same coverage).
But – for starters – how about an approach that’s open and transparent. -
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January 19, 2010
Dr. Robert Goldberg
What exactly about the Scott Brown victory does Ezra (the mind of moment) Klein not get?
"There's nothing about Scott Brown's victory that needs to derail health-care reform in particular, or the rest of Obama's 2010 agenda in general. But if Democrats decide to cower and hide, they can end Obama's presidency on Brown's behalf. That said, I really wonder what the Democratic Caucus thinks will happen if they let health-care reform slip away and walk into 2010 having wasted a year of the country's time amidst a terrible recession. It won't be pretty, I imagine. If health-care reform passes, the two sides can argue over whether it was a success. If it fails, there's no argument." voices.washingtonpost.com/ezra-klein/ I have heard that petulant "it's all about me" tone before.. It's the gift that keeps on giving to those of us seeking sensible health care reform consistent with the need to sustain job creating biomedical innovation... I hope Klein and others keep pushing Dems to ignore the outrage of the voters... It will produce more Scott Browns. -
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January 19, 2010
Dr. Robert Goldberg
Michael McCaughan's blog in RPM First Take reveals that the operational definition of a follow on biologic is simply someone else's product that we want to copy...
therpmreport.com/Free/4e767e88-bc84-40e1-871a-4025e307e300.aspx Saturday, January 16 2010 Teva’s Hedge on Complex Generics By Michael McCaughan Generic applications for Lovenox and Copaxone have become bellwethers for the emerging follow-on biologics pathway in the US. Teva is on both sides. Who says you can’t have your cake and eat it too? When it comes to the follow-on biologics space, there are plenty of companies who are likely to try. As we’ve written before, the looming new pathway for abbreviated approval of biosimilars opens up opportunities for lots of companies—brand, generic and biotech—to consider whether to play as a true “follow-on” supplier, focus on improved “biobetters,” or do both. But no one is in quite the same position as Teva. Not only is the company doing that analysis for the longer term biosimilar opportunity (you can read more about its latest thinking in “The Pink Sheet” DAILY here), but it is on both sides of the issue for two near-term decisions on complex molecules that are regulated as drugs. Teva is one of three companies (along with Momenta and Amphastar) with pending applications to market a generic version of Sanofi Aventis’ enoxaparin (Lovenox). In that case, Teva wants FDA to agree that, while enoxaparin is a relatively complex molecule, it is not too complex to allow for a fully substitutable generic approval. On the other hand, Teva’s largest and most important product is the branded multiple sclerosis therapy glatiramer (Copaxone). There are two would-be generics pending, Momenta’s and Mylan's. In that case, Teva is arguing that Copaxone is far too complex a molecule to be copied closely enough to allow for substitutability—and is even suggesting that other manufacturers may have trouble even getting a non-interchangeable product approved without full clinical studies. Teva, of course, is aware that this may sound like trying to have your cake and eat it too. But they don’t see a contradiction. Here is how Teva CEO Bill Marth put it during the Goldman Sachs CEO “unplugged” conference Jan. 6: “When you think about Copaxone, many people try to equate it to Lovenox. It is much, much different—vastly more complex—than Lovenox will ever be. We have not characterized it. We don't believe it can be fully characterized. If one cannot fully characterize Copaxone, I'm not sure how you get it approved without a clinical study since the method of action is not well understood and exactly what the active sequence is. And, by the way, we think there are multiple methods of action, and potentially multiple reasons for that. We think that it is virtually impossible to prove your efficacy without a clinical study. So it really falls into more of that sweet spot of the biologics.... I think it is much different with Lovenox than it is with Copaxone because with Lovenox, the active sequence has been identified by us. It hs been identified by the innovators. It has been identified of course by Momenta and Amphistar. So it is defined. It is a sugar. When you look at those sugars and you look at the active sequence, then what you really have to do is understand what is the other stuff or junk that is within your protein or sugar, and there make sure that you don't have improper immunogenicity. They have asked us for immunogenicity testing. We have done that. And it seems to be acceptable so far.” In other words, Teva thinks it can kept its Copaxone cake and take a huge slice of Sanofi-Aventis’ Lovenox cake too. But there are other outcomes. From Teva’s perspective, an outright rejection of substitutable Lovenox wouldn’t be so bad, since it would underscore the company’s position that substitutable Copaxone is a pipe dream. And while Teva would dearly love to tap into the $2 billion Lovenox market, at best it will only get a percentage of a big generic opportunity. With Copaxone, Teva hopes to maintain its own multi-billion dollar brand in something like perpetuity. How important is that to the company? During its January 7 investor day, Teva’s bullish forecasts for growth for 2015 included what the company called a “conservative” forecast for Copaxone, with sales peaking at $3 billion and then eroding over time to $2 billion in 2015. But the erosion, in Teva’s view, will come only in the face of competition from other MS agents (including Teva’s own oral product)—not from any substitutable generic competition. So call it a hedge: if generic Lovenox is rejected, Teva’s Copaxone franchise is more secure. If Copaxone can’t be protected, at least Teva will have some generic enoxaparin revenues to fill in the hole. There’s really only one scenario where Teva loses. If one of the other applicants (Momenta being the most likely candidate) actually has superior technology, it could potentially get approval for generic Lovenox and generic Copaxone, while no one else can. For Teva, that would be more like a pie in the face. -
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January 19, 2010
Peter Pitts
From the UL newspaper, The Telegraph: The Government’s drugs rationing body, the National Institute for Health and Clinical Excellence (Nice), has provisionally said that it does not intend to recommend the use of the drug, called Tocilizumab, or Roactemra.Nice claims that the £9,000 a year drug, for rheumatoid arthritis, has not proved that it is cost effective.But patients in Scotland are to receive the treatment after it was recommended by the body which regulates drugs on the Scottish NHS, the Scottish Medicines Consortium (SMC). The move will reopen accusations of medical ‘apartheid’ within Britain. It follows an outcry after patients in Scotland were given access to expensive cancer drugs denied on the NHS in England and Wales. Roactemra has been described as a “life changing” drug because it can be taken after other medications have failed, a common problem in the treatment of rheumatoid arthritis.Patients groups last night said that denying the medication to tens of thousands of patients with the crippling condition in one part of the country was “cruel”. Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society (NRAS), said: “I have heard patients stories that would make you weep. “People are virtually suicidal because they have nowhere else to go and yet they know that there are other drugs out there that they could have access to but cannot because of Nice.” She added that it was “ludicrous” that the drug would be available in Scotland “and yet two miles on over the border you can’t get it.” The drug - the first new arthritis treatment for a decade - is already used in most other European countries, including France and Germany. It offers another option for patients for whom other treatments have failed or no longer work and is used in combination with a standard anti-inflammatory drug, called methotrexate.Currently many rheumatoid arthritis patients receive methotrexate as a first-line treatment to ease their symptoms. In later years they are offered another class of drugs, called anti-TNFs, together with methotrexate, but even combined the effects of the drugs can wear off. In combination Roactemra has been found to improve the rates of remission of the illness sixfold in comparison with just methotrexate alone. The SMC - set up in the aftermath of devolution to make decisions about drugs north of the border - has agreed that the drug can be used for patients suffering from moderate to severe forms of the disease for whom other medications no longer work. Prof John Isaacs, from Newcastle University, said: “This is fantastic news for people in Scotland who suffer from this disabling, lifelong disease. “However, it also highlights the disparities in accessing treatments between Scotland and the rest of the UK. “Because Roactemra works in a completely different way to the existing drugs it is likely to be effective in some patients where the other drugs don’t work or have stopped working, providing an extremely important option for these individuals.” Neil Betteridge, chief executive of Arthritis Care and vice president of the European League against Rheumatism (EULAR), said: "There are a number of treatments for RA currently available but they simply don't work for everyone. "There are people who are most severely affected by this debilitating condition – living in intense pain, unable to work, often struggling even to walk – who have been failed by existing treatments, and it's for them that tocilizumab could provide real hope.” He called on Nice to follow the lead of the SMC and approve the drug for use in England and Wales. Up to 37,000 patients across Britain would be eligible for the drug. But local health care trusts do not have to pay for drugs which have not been approved by Nice. In December Nice took the unusual step of challenging Roche, the drug’s manufacturers, to provide more evidence of that the drug was cost effective. A final Nice appraisal of the drug is expected later this year. Around 646,000 people in Britain are though to suffer form rheumatoid arthritis, in which their own immune systems start to attack their joints. The condition can be extremely painful and debilitating. Around half of sufferers are too disabled to work within a decade of the disease taking hold. The direct and indirect costs of the disease are estimated at £3.8 billion to £4.75 billion a year in the UK alone. Nice has previously come under fire for refusing drugs which have been approved by the SMC. Herceptin, a £21,000-a-year drug for breast cancer, was initially turned down by Nice but available in Scotland, which has its own health budget. A climb-down, ordered by Patricia Hewitt, the then health secretary, allowed the drug in England and Wales. Patients in Scotland also had access to Tarceva, a lung cancer treatment, which costs about £1,700 a month, two years before the rest of the country. Nice also provoked outcry by turning down Lucentis, a £20,000-a-year treatment available in Scotland for wet age-related macular degeneration, one of the most common causes of blindness, although it later also reversed that decision. -
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January 18, 2010
Dr. Robert Goldberg
This is prompted by the latest posting of one of the "leading" liberal health care "experts", Ezra Klein. Expert not because he has practiced medicine (he has not), or published anything close to an original piece of research on health care delivery or economics (nothing there either) or worked in health care (no).. Rather he is an expert by virtue of his position as a blogger he has helped shape liberal opinion and policy that went into the current malformation of a proposal that is causing Democrats to go down in flames.
Thanks Ezra. Part of Klein's contribution to Democrat demise is perpetuating the belief that all people cared about was the total cost of the bill, which he once again argues, is really not so big when you consider say, what it would cost to build the entire fleet of Starships for the Federation. Well, okay, maybe not that much but here is Klein at his misleading and misinformed best: "by the standards of the health-care system, it's not that big at all. It goes two-thirds of the way on covering the uninsured. It makes a courageous, but insufficient, start on cost control. This is the beginning, not the end, of reform. Let's begin by breaking down the numbers. The $900 billion price tag is repeated with the regularity of a rooster's crow. That's a shame, as the number is, somewhat impressively, misleading in both directions. On the one hand, that $900 billion is stretched over 10 years. But people don't think in 10-year increments. They don't pay taxes once a decade. Put more simply, the bill will cost an average of $90 billion a year. But that number is meaningless without context. Ninety billion is a lot more than you probably paid for, say, your house. But is it a lot of money in the context of national health-care spending? Not really. In 2008, we spent $2.3 trillion on health care. Ninety billion is about 4 percent of that. In other words, a drop in the bucket." In Massachusetts, which has enacted what is essentially the Democrats' health plan, mandatory premiums account for about 60 percent of overall costs, according to the Massachusetts Taxpayers Foundation. On-budget government spending is just 40 percent. By my count, mandatory premiums accounted for a similar share of the Clinton health plan's projected cost. So while the CBO estimates that the coverage expansions in the House Democrats' legislation would trigger about $1 trillion of new federal spending over ten years, the actual cost of those coverage expansions is more like $2.5 trillion."
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January 15, 2010
Mario Coluccio
Throughout the health care debate, the pharmaceutical and biotech sectors have repeatedly given more and more to Congress and the Obama Administration in a good faith attempt to contribute to health care reform. What have the Big Labor unions sacrificed? What about the trial attorneys? In fact, the generic drug firms are spared from the numerous taxes in the health care bill. Brand-name drug producers and medical device manufacturers aren’t so lucky. Now the industry has given $10 billion more on top of the original $80 billion agreement. But that’s not enough for President Obama and Congressional leaders. Politico reports: President Obama told House Democrats on Thursday that he wants to reduce the amount of time certain biotechnology treatments are protected under an agreement in both the House and Senate bills. His comments come as negotiators seek billions in additional revenue from the pharmaceutical industry. Ironically, his last-minute push, which comes as negotiators try to bridge divisions between the House and Senate bills, undermines one thing that both bills share: a 12-year exclusivity deal allowing the producers of so-called biologics to make and market treatments without competition from generic manufacturers. One option on the table would reduce the exclusivity period to 10 years, sources say. A drug industry source didn't know how much the change could cost the industry largely because drug makers were caught off guard when Obama decided to weigh in on the issue yesterday. “It’s a significant loss if we lose that,” the source said. The source predicted the move could rattle Democratic lawmakers from Colorado, Massachusetts, North Carolina and other states that have a significant industry presence. Representatives Anna Eshoo (D-CA) and Mike Rogers (R-MI) worked diligently to secure widespread bipartisan support for the 12-year exclusivity deal. President Obama and Congressional leaders should not at this stage in the process look to further harm the future of drug innovation in this country by squashing this provision. At some point the industry has to say enough is enough. -
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January 15, 2010
Dr. Robert Goldberg
Now that the unions are getting a tax break on their health plans the rest of us will not get, the President is dialing for dollars to cover the cost. He is actually picking up the phone and calling members of Congress to shorten the amount of time before generic companies can try to produce their own version of biotech drugs from 12 years to 8 years and allow a short cut around the FDA’s efforts to come up with an approach that insures that medicines meant to heal don’t maim.
For every 10 percent shaved off the life of patent protection, biotech investment declines by 10 percent. Over the next 15 years, the Obama deal would cut biotech investment, heavily concentrated in the Bay State, by 33 percent. Every biotech dollar invested has a ripple effect in terms of jobs, spending and investment in related businesses. Cut biotech spending by a third and the impact on economic growth will be magnified in reverse. Then there is the human element. For cancer an increase in the number of biotech drugs iis associated with an increase in both the one-year and the five-year survival rate for all forms of the illness. For orphan disease, it has meant longer lives for people with lupus, cystic fibrosis, MS, Gaucher’s disease, HIV, etc. Less investment, fewer drugs, more deaths sooner. That’s one way to keep costs down and pay for the union tax break. Finally, Obama wants to save a few million by cutting corners on drug safety. Current proposals require genetic companies to demonstrate 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. Even changing the size of the molecule of the same protein can turn of biosimilar from avatar of health into an avalanche of deadly side effects. But Obama wants safety to meet budgetary, not scientific standards. -
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January 15, 2010
Peter Pitts
Having been rebuffed in his own committee on follow-on biologics, Mr. Waxman is trying to roll the President. That’s petty politics and bad public health policy.
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