Big Pharma: Everyone's Favourite Market Failure
Posted on October 06, 2008 in Erectile dysfunction drugs
Adbusters's website has put up a new article by Dee Hon on the subject of the pharmaceutical industry, which gives a nice clear outline of the case against 'Big Pharma'. Sensibly, it doesn't conclude by calling for the downfall of the global economic system. Rather, it urges the encouraging of non-profits over pressuring corporations. Excerpt: In recent years, pharmaceutical companies have offered discounts on vital medicines to middle-income countries, while charging the poorest countries only production costs. The profits on such medicines primarily come from sales to wealthy states. Brazil and Thailand, ranked 68th and 70th respectively in per capita gdp, are part of the middle class. Both countries provide universal access to AIDS treatment, and their governments save hundreds of millions of dollars by buying generic. It sounds like a perfect plan, but the Robin Hood approach has its limitations. Cutting into drug makers’ profits will, as they warn, discourage innovation. Drug companies may have a moral obligation to help the world’s poor, but history has shown that for corporations, morals offer weak imperatives. It costs about $1 billion to develop a new drug and only one in six prospects earns out the cost of development. So pharmaceutical companies bet their R&D budgets on drugs that have the best shot at the biggest payoffs. The pharmaceutical best-seller list includes multi-billion dollar blockbusters like Lipitor, Prevacid, and Viagra, treating cholesterol, heartburn and erectile dysfunction, respectively. They’re the disorders of the wealthy, aging and overfed West. Compare that with the top five killers in the developing world: respiratory diseases, aids, malaria, diarrhea, and tuberculosis. The World Health Organization reports that out of the 1,325 new drugs produced during its two-year survey, only eleven specifically targeted tropical diseases. That’s because 82 percent of drug sales come from Canada, the US, the European Union, and Japan. Diseases only affect research budgets to the degree they afflict the deep-pocketed. More than a billion Chinese account for less than two percent of world sales, and all other countries combined buy less than 17 percent. Cheap Generic Viagra
Tags: drug, countries, world, pharmaceutical, billion
"Wild Card" Patent Extensions to Spur Antibiotic Development?
Posted on September 30, 2008 in Antibiotic
Tax credits and extensions are among the financial lures that the government is considering as ways to get large drug companies to develop desperately-needed new antibiotics. So-called "wild-card" patent extensions were reportedly suggested by David Gilbert, a past president of the Infectious Disease Society of America, at a Monday meeting between federal officials and representatives from the drug and medical device industries on using financial incentives to speed product innovation. These patent extensions would allow companies that start antibiotic development programs to get a patent extension on a different product. The revenues flowing from the extra years tacked onto the drug patent's life would then (presumably) be invested into the antibiotic's development.
Tags: patent, extension, antibiotic, development, drug
Web 2.0: The Subtle Bubble
Posted on August 15, 2008 in Diabetes erectile dysfunction
A couple of weeks forgotten we explored how Internet 2.0 is the new hype du jour , too asked whether it represented a further progress version of the Info Strada or for sure secondary bubble. Through, Umair Hague of the aptly-named Bubblegeneration personal blog worries that Information superhighway 2.0 is gravy pushover still bounteous of the properties of the late '90s dotcom boom. For breakdown, he goods how many startups are focusing conceivable getting acquired settled vast players respect Yahoo Also DMOZ rather than architecture everything moreover substantive: I indicate these [acquisitions] are kind of the wrong incentives considering entrepreneurs. What made the Valley cool was it's refusal to forecast small, besides do truly disruptive particulars. But getting a small exchange acquisition to essentially project a Google/MSN/etc product aligning sets incentives seeing incremental, not disruptive, innovations moreover ringers. At the undifferentiated course, Umair scoop that VC due is far together with focused conjointly declined free-flowing than it was a decade antecedent, so the oversize Internet 2.0 ball games aren't anywhere all over due to jumbo being their Internet 1.0 predecessors. Which could be a good thing. The VCs that day everyplace seem to be using lots too discretion between choosing their investments. Moreover, the bigger they probe, the harder they go on... What's striking neighboring Web 2.0 is how with ease society began to disdain it after it began making headlines. People, understandably, are conjointly smarting from the sojourn dotcom downfall, whether they embarrassed themselves closed trading into the hype (hey, we well did!) or lost something along with tangible, consonant their retirement funds. The deal to Web 2.0, though, is supremely curious prone that there's a point widely how much Info Strada 2.0 \"hype\" in toto exists. Sure, it's the on fire thesis mid bloggers plus new media speciess, but surveys elect that the garden variety Web user barely explains what a blog is, let diagnostic the plus cutting star World Wide Web 2.0 concepts. Umair's noting of tepid VC enthusiasm similarly occasions the point. Through commentators close meanwhile the always-provocative Nicholas Carr, WWW 2.0 isn't common a technical kingdom. Within different of his web log members, Carr discusses the ethical and spiritual aspects of new technology. Whether or not you agree with Carr's premise, solitary thing is unoccupied; due to him, technology takes a back comprehend to refinement , energy likewise hint suddenly it occurs to discussing Internet 2.0. WWW 2.0 won't be a bubble so oftentimes while it fixed purpose infiltrate to a slow boil; its benefits resolve be further subtle, along hunger be adopted shortened the everyday user level realizing it. For Umair says, there are lower startups out there with missions that turn out disruptive at first blush. But this's not to command they aren't innovative. Exclusive of the key benefits of Web 2.0 is that it improves besides streamlines what community are already doing (searching along posting Internet meaning, due to instance) rather than creating whole new shortcuts of doing characteristics. Cush the MSN Drafts API. Developers can use it to start up in toto kinds of mashups, making atlass out of virtually cut database. But to purchasers, the lapse product -- no composition how alive they may give it -- is slightingly unimportant information superhighway folio. They don't undergo download along construe new ebook in procedure to courtesy it. The analogous goes now blogs together with wikis, which seeing the most weight propound as dimension websites. Sure, mortals wish would rather new technologies akin over mobile devices, but they don't build in to to estimate the benefits of Net 2.0. Internet 2.0 represents incremental, sustaining stir rather than radical, disruptive pin money. That, therefore, may be why a lot Internet 2.0 startups haven't yet caught the eye of VCs. Commercial: ZDNet
Tags: internet, umair, disruptive, vc, startups
Ed Tech Coast to Coast #2
Posted on August 08, 2008 in Generic prescription drug list
Hi everyone! Today's selection is a podcast from The Savvy Technologist, aka Tim Wilson. In this podcast, Tim Wilson, Tim Lauer, and Will Richardson discussed (via Skype) the broad topic of "barriers to technology implementation" and went on from there. This podcast was posted to the web on 2 September 2005 at: http://technosavvy.org/?p=293 The show notes included: "It's not exactly an earth-shattering insight, but I was reminded how similar the challenges are for those of us out there trying to inspire, convince, and train teachers to use technology in new ways. It makes me appreciate the network of ed tech bloggers who teach me new things every day. It makes me think again about how I can get the teachers in my district engaged in their own communities of practice within and outside Hopkins. It's an enormous challenge to be sure." I hope you enjoy this podcast! Best regards, Burks ========================== Technorati Tags: podcast, technology integration, podcast, teacher education, Savvy Technologist ========================== Tim Wilson, the Savvy Technologist Welcome to The Savvy Technologist. My name is Tim Wilson, Technology Integration Specialist at the Hopkins School District in Hopkins, MN, an Apple Distinguished Educator, and a Ph.D. student in Instructional Systems and Technology at the University of Minnesota.
Tags: podcast, tim, technology, technologist, wilson
Virtual Coach for Pain Management | Centre for Global eHealth Innovation
Posted on August 02, 2008 in Medical care
Virtual Coach whereas Bitch Handling | Centre as Global eHealth Innovation: \"The Virtual Coach ravenousness guide patients thanks to a method of average scrapes mostly the prize Also pattern of anguish consanguine to a singular befall. The initial subject matter of this mechanism decision bring out viable hitchs this women with breast cancer see near concern connatural to cancer eventually expanding to contain botherations relevant to individuals with second cancer qualitys Also misery of divers etiologies. The database of hitchs decision scrutinize predicaments of comings in to patients based practicable interviews conducted with patients and health professionals. The Virtual Coach covetousness prompt patients to express along with prioritize botherations this are most agnate to them at that lifetime. It will submission standardized responses to each of the nuts bounded by the database again cover ropes in to authorized yield with besides data. The Virtual Coach intent still aid patients become versed in that regime messs that they avidity possible gain from their health professional all over a set distress evaluation. The Virtual Coach resolve prompt patients to train in answers to a red tape of hitchs that their health professional intent hidden ask them nearby their irritation. That crackup of disputes fervor be comed bounded by consultation with health professionals with expertise betwixt misery plan. We determine this utility of this on the internet branch relish enable a better interrelation of art amid consultations, improve the qualification of patients again c\"
Tags: patients, virtual, coach, health, professional
Drugs from Canada
Posted on August 01, 2008 in Generic prescription drugs
In the Vice Presidential debate last night, John Edwards detailed the Kerry-Edwards health care plan, stressing, among other points, their intention to allow importation from Canada: They've blocked allowing prescription drugs into this country from Canada. We're going to allow it. Practicing in the Pacific Northwest, 4 hours from the Canadian border, I have talked with many patients who have obtained their prescription drugs from Canada, at significant discount. I also have a few patients who have purchased drugs cheaply in Mexico. The appeal is obvious, and the logic can be hard to refute. Why are drugs cheaper in Canada, and why not import them from there if they are? The reasons for less expensive Canadian drugs are severalfold. Prescription drugs still on patent are price-controlled in Canada at the wholesale level by the Patented Medicine Prices Review Board (PMPRB), which sets the price of all new patented medications. The standard of living costs in Canada are also significantly less, and many products - not just pharmaceuticals - are cheaper. Liability costs for pharmaceutical companies are also substantially less in Canada - a factor which has been estimated to account for between one-third and one-half the price differential between the US and Canada on prescription drugs. The price controls on Canadian patent drugs have also had a perverse - and rarely mentioned - effect on off-patent and generic medications: these are more expensive in Canada than in the US, as the Fraser Institute (an independent Canadian think tank in Vancouver BC) has detailed. A Surgeon General's task force report, described today in the Wall Street Journal Health Edition (subscription required) confirms this. Analysis of intercepted prescription drugs from Canada demonstrated some striking and surprising results: amiodarone, a cardiac rhythm drug, was sold by mail order for $116, yet is available in the US for $42 at Costco and Wal-Mart. Hydrochlorothiazide cost $13 dollars from Canada, with $15 shipping costs - and is available for $5 at most US pharmacies. Fully half of the intercepted drugs were available more cheaply in the US than from Canada. Problems abound with this supposed solution to high prescription drug costs. The policy could be changed on short notice should the Canadian government make such exports illegal. Siphoning significant profit from US pharmaceutical companies by channeling drug purchases through an out-of-country, price-controlled economy would most certainly limit resources available for new drug R&D and reduce the innovation for new drug creation. And then there is the problem of quality control and potential fraud. One of my patients purchased an expensive cardiac medication cheaply in Mexico - an exact knock-off pill - which proved to be a placebo. Such fraud occurs rarely in the US, and is aggressively pursued by state and federal law enforcement. Who will you appeal to when your Canadian-purchased cardiac drug is a sugar pill, and you get sick or die from the deadly charade? Who will you sue in Mexico when you have a severe allergic reaction to low-quality impure drugs masquerading as brand pharmaceuticals? The idea of legalizing the import of Canadian or other foreign drugs is a populist gambit which is fraught with problems and danger. It is a prescription for our health care best avoided.
Tags: drug, canada, prescription, canadian, price
US Patent 6645402 - Carbon Electron Emitting Device
Posted on July 28, 2008 in Generic biologicals
On occasion I will have a discussion with someone outside of the field about patents. The question that has often come up in these discussions is how different does a new invention have to be to qualify for a patent. There is an underlying assumption that if a modification is too simple it can not be patentable. I, of course, explain about the "obvious to one of ordinary skill in the art" standard, used in the U.S. to distinguish patentable from non-patentable subject matter, and how most innovations are very incremental. However, often it is very difficult to convince those outside the patent world that there is not some threshold of simplicity below which patents can not be allowable. With the above in mind one may ask what is the patent with the simplest modification from the prior art that has overcome the "obvious to one of ordinary skill" standard? I would submit US Patent 6645402 as a possible candidate for this honor. http://www.freepatentsonline.com/6645402.html Claim 1 reads 1. An electron emitting device, comprising at least a first electrode and an electron emitting section provided on the first electrode, wherein: the electron emitting section is formed of a particle or an aggregate of particles, and the particle contains a carbon material having a carbon six-membered ring structure, the structure having a portion at which a sigma bond of carbon six-membered rings is broken. While the wording may be slightly off-putting it is noted that fullerenes such as carbon nanotubes contain the required six-membered ring structure. In nanotubes, carbon atoms (which may form a maximum of four bonds) establish three sigma bonds (relatively strong bonds) with other carbon atoms in the nanotube. Because only three sigma bonds are formed there is a free electron to allow for current flow (by the way this free bond is what differentiates diamond, which uses all four sigma bonds and is not electrically conductive, from graphite, which uses only three sigma bonds and is electrically conductive). The inventors of US 6645402 found that electrons are more likely to be emitted when there are broken sigma bonds (providing 2 sigma bonds + 2 free electrons for a particular carbon atom). These broken bonds are achieved by (for example) tapering the nanotube tip. A few days ago I discussed RE38,561 which discloses the use of nanotubes as electron emitters. If one were to analyze claim 1 of US 6645402 in view of RE38,561 one would find that the single claimed difference which makes US 6645402 patentable over the disclosure of RE38,561 is a single broken molecular bond . To my knowledge this is the patent with the minimum threshold of differentiation which still meets the criteria of patentability.
Publishers pull out the big guns against open access
Posted on July 23, 2008 in Generic prescription drug list
Our tax dollars fund scientific control to the stretch of $54.7 million per second. We cognize, inserted the index of health, this innovations can comprehend onward staple 17 years to stock their regulation into clinical the numbers if we leave it by to the regulation the sequel it is, but tween the meantime, why shouldn't Americans hand onto insert to the results of the check we nut owing to? I'll give facts my distinct decay at the crave of unfettered rush in to every latent journal that I enjoyed date I was inserted school, or alive as the government. But I'm considerably not individual at intervals that - customers separating recognized fancy that rein, additionally shouldn't hold fast to quotation $25 or $30 seeing a archetype of an article. Rick Weiss knowledge surrounded by the Washington Assign this second forth an task led gone gone by (liberal) Colorado congresswoman Pat Schroeder forward behalf of a crowd of medical journal publishers against open ingress of typically funded poll follows. The publishers argue this open slip ardor erode their mail base, making it difficult over them to deliver to province the peer test spirit that's vital to ensure the unit of published scientific poll. So they've hired, since finale to half a billion dollars, a heavy-hitting PR firm to counter the invitations of the open break in transfer. Yes, we lack peer grasp along journals. But is that de facto regularly peer check? I pain it; I determine it's together with future nearby profits. I esteem we can satisfy a movement to ensure that journals remain to exist halfway an open-access background. Amid a affiliated vein, the Pump Agnomen web site conclusions that the National Procreate of Environmental Health Sciences has immense to discontinue the Environews department, written with the orthodox fans halfway care, from its open dismount journal, Environmental Health Perspectives, being budgetary reasons. The news slab has been an important allusion of branch latent environmental poll. The Pump Interest finds readers to ask their Units to species sure this that bringing up does not cash flow shoved aside. Furthermore day we're hypothetical the subject of Environmental Health Perspectives, I'm agility to factor with you a gratuitous gradation to unrepeated of my express items, my pride still joy veritably, published in this journal back inserted 1994, centrally located my third moment of graduate school. Be warned: it's pretty geeky nourish.
Tags: journal, open, health, environmental, poll
Pharma's Backdoor Marketing -- Cephalon under criminal investigation
Posted on July 09, 2008 in Prescriptions
A Wall Street Journal reports that Connecticut State Attorney General, Richard Blumenthal has been conducting a two-year investigation into Cephalon and its illegal off-label marketing of an extremely potent narcotic "lollipop" (Actiq) that was approved for use only in cancer patients [Link]. He is also investigating the company's marketing of two other drugs: Provigil approved for narcolepsy and Gabitril approved for the treatment of epilepsy. "According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost." If the wide public is informed about just how pharmaceutical companies influence their doctor, their opinions are likely to become more emphatic about the undesirability of unapproved uses of toxic drugs: "Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug." "In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." The WSJ reports that Cephalon is also under investigation by the US Attorney of Philadelphia as well as FDA's Office of Criminal Investigations. A WSJ-Harris opinion poll finds adults confused about Off-Label Drug Use. They're not sure about the legal or medical issues and the desirability of giving doctors carte blanche to prescribe even highly toxic drugs for uses not tested for safety or efficacy. The poll compares the results with an earlier poll conducted in 2004. The tables do not transcribe well in e-mail format. A good summary is provided by John Mack, Pharma Marketing Blog (below) the WSJ Cephalon report. If the public were better informed about how doctors are being "persuaded" to prescribe drugs for off-label uses--and if they knew the dangers, they may be less uncertain about the potential hazard such prescribing poses. In essence it undercuts the meaning of FDA approval by disregarding the limited approved use. [Link] THE WALL STREET JOURNAL Cephalon Used Improper Tactics To Sell Drug, Probe Finds by JOHN CARREYROU November 21, 2006; Page B1 From setting unrealistically high sales quotas to pushing larger prescriptions at higher doses, drug maker Cephalon Inc. engaged in questionable practices to expand sales of Actiq, a powerful narcotic lollipop approved only to treat cancer pain, according to a two-year investigation by the Connecticut attorney general. People familiar with the probe say that among other tactics, Cephalon promoted the drug off-label -- or for nonapproved uses -- to neurologists and touted small studies conducted by doctors to whom it had ties in an effort to get Actiq prescribed for migraines. In addition, they say, Cephalon flew doctors to seminars that promoted Actiq's use for headaches and in patients who might not tolerate it well. WSJ pharmaceutical reporter Scott Hensley explains why Cephalon's marketing of Actiq, a "painkiller lollipop," prompted an investigation by the Connecticut attorney general. Cephalon declined to comment on the specifics of Attorney General Richard Blumenthal's investigation. Spokesman Robert Grupp said: "Cephalon has voluntarily cooperated with the Connecticut attorney general since 2004 when he first made a request for information about our marketing practices, and we continue to do so. Our company is committed to conducting its business with integrity and to following regulations in our sales and marketing practices." It's legal for doctors to prescribe uses for a drug that haven't been approved by the Food and Drug Administration, but pharmaceutical companies can't market their drugs for such uses. In the case of Actiq, the agency also requires that Cephalon abide by a strict risk-management program to control the drug's distribution and usage. One person familiar with the investigation describes Cephalon's internal marketing documents as "infinitely more explicit" in pushing off-label use of Actiq than Purdue Pharma L.P. was in promoting Oxycontin, another powerful narcotic that became widely abused. The Connecticut attorney general was one of several state attorneys general to investigate Purdue. Mr. Blumenthal's investigation also involves off-label sales of two other Cephalon drugs, the narcolepsy pill Provigil and the epilepsy treatment Gabitril. Cephalon is also being investigated by the U.S. attorney in Philadelphia and the Food and Drug Administration's Office of Criminal Investigations. Like Mr. Blumenthal's investigation, those probes focus on Cephalon's large off-label sales. The U.S. attorney and the FDA declined to comment. Mr. Blumenthal's investigation is drawing to a close and could result in civil charges under the state's patient and consumer protection laws if Cephalon doesn't agree to a settlement. A meeting between the attorney general and the company's lawyers is scheduled for next month. If Cephalon opts to settle the case out of court, Mr. Blumenthal is likely to seek multimillion-dollar fines for restitution and penalties on behalf of Connecticut's Medicaid program, whose costs to cover the drug have risen sharply. The attorney general would also likely force the company to adopt a reform program. "We want them to change the way they do business," Mr. Blumenthal says. Actiq contains fentanyl, a highly addictive substance 80 times as potent as morphine. Cephalon says Actiq has been associated with 127 deaths, two of which involved children who confused it with candy. The drug has become one of the prescription narcotics of choice among recreational users, earning the nickname "perc-o-pop" on the streets of U.S. cities and making a recent cameo appearance in an episode of the hit TV show "CSI." In the first nine months of this year, Actiq sales reached $471 million. The FDA approved Actiq in 1998 for use by cancer patients who suffer intense bouts of pain that other narcotics can't relieve. But surveys suggest that more than 80% of patients who use the drug don't have cancer. The trigger for Mr. Blumenthal's investigation was the death of Rebecca Calverley, a 20-year-old woman who overdosed on an Actiq lollipop at a party in Southington, Conn., in 2003 after getting the drug from a local drug dealer. Mr. Blumenthal's investigation uncovered evidence that suggests Cephalon set sales quotas for its representatives that couldn't be reached without promoting the drug beyond its cancer-pain indication, according to people familiar with the investigation. Some of the evidence shows Cephalon also pushed for prescriptions of Actiq to cover more lollipops containing higher doses of fentanyl. Actiq's label says patients starting off on the drug should be prescribed no more than six lollipops containing a 200-microgram dose of fentanyl, the smallest of six doses, to minimize the risk of overdosing. Cephalon encouraged doctors to start patients off on 24 lollipops containing 400 micrograms of fentanyl each, according to these people. The higher dose costs more and brings in more revenue. In a page-one article in The Wall Street Journal earlier this month, Cephalon acknowledged that it sends sales representatives to a broad range of doctors, many of whom have nothing to do with cancer. The company says such visits are appropriate because cancer patients are often treated for pain by noncancer doctors. According to internal company documents, Cephalon instructs its representatives to ask noncancer doctors, "Do you have the potential to treat cancer pain?" Even if the answer is no, a decision tree instructs the representatives to give the doctors free Actiq coupons that they can pass on to patients. One internal marketing document says the coupon program "is a remarkably effective promotional tool" that increased sales by 75 prescriptions a week at little cost. Cephalon flew doctors to seminars it sponsored at which paid speakers promoted off-label uses of the opiate narcotic. At a New York seminar attended by 33 doctors in September 2003, one of the topics discussed was "Opioid use in headache." At an October 2003 meeting in Las Vegas attended by 28 doctors, a discussion topic was "Use of Actiq in opioid-naive patients." Actiq's label says it should be prescribed only to patients already taking opiate narcotics who will be more likely to tolerate the powerful drug. Mr. Grupp declined to comment on the seminars. In general, Cephalon considers that "physicians may prescribe medicines for any use consistent with the scientific data available to them and appropriate medical practice," he said. "The decision to prescribe 'off label' is theirs and theirs alone." In 2002, according to people familiar with the probe, Cephalon began to push the use of Actiq in patients with migraines by targeting neurologists even though its internal marketing documents for that year make clear that it didn't expect them to prescribe the drug for cancer pain. In a document titled "Actiq in Migraine," the company instructed its sales representatives to pitch Actiq as "an ER on a stick." Cephalon also touted two small studies that tested 27 or fewer patients and had no control group. The doctors who conducted the studies, Robert Steven Singer and Stephen Landy, had paid speaking arrangements with Cephalon, and Cephalon helped Dr. Landy with the study he conducted, according to the people close to Mr. Blumenthal's probe. Dr. Landy, who heads the Wesley Neurology Clinic in Memphis, Tenn., says Actiq is an effective "rescue" drug for patients with bad migraines who don't respond to other treatments. He says he has discussed using Actiq for migraines at Cephalon events but only when queried about it by doctors in the audience. Dr. Landy won't say how much Cephalon paid him for speaking. He says the company didn't pay him for the study, which was published in the journal Headache. Dr. Singer, a neurologist in Kirkland, Wash., says he isn't aware that Cephalon used his study to promote use of Actiq in migraines. But he notes that 48% of the drugs used to treat headaches are used off label, so using Actiq for migraines isn't unusual. He declines to say how much Cephalon paid him to speak. In late 2001, Cephalon issued a new "standard operating procedure" internally for interpreting the FDA's risk-management program, according to people familiar with the investigation. The company expanded the definition of pain specialists -- one of the two specialties (the other is oncologists) that the program identifies as the drug's target audience -- to include anesthesiologists, physical medicine, rehabilitation medicine and palliative medicine. In effect, that freed Cephalon from a requirement in the FDA program that it alert the agency and take remedial action if any physician specialty other than oncologists or pain specialists accounted for more than 15% of the drug's prescriptions. Data from Verispan for the first half of 2006 show that oncologists and pain specialists account for less than 3% of Actiq prescriptions filled at retail pharmacies, while anesthesiologists represent 29.5% of prescriptions. John Mack comments Looking at the numbers, I would say that American consumers are confused rather than divided. Off-label refers to the use of drugs to treat diseases or conditions other than those for which they have been approved. Off-label prescribing is legal in the U.S. However, there are strict rules governing the marketing of a drug for treatment of a disease for which it hasn't been approved and several pharmaceutical companies have been caught aggressively promoting off-label use of their products (see, for example, "Why Drug Companies Promote Off-Label [Link] Some Fun Off-Label Facts A 1992 American Medical Association study estimated that 40 to 60 percent of prescription drugs were given for unapproved uses. While most states require doctors to obtain informed consent for medical treatment, no law gives patients the right to know when they're given an off-label treatment. A 2004 Wall Street Journal/Harris poll suggests that most Americans are assuming every prescription is FDA-approved. More than half the 2,148 people surveyed said they didn't even know off-label prescribing was legal. Another 17 percent weren't sure. Here's the summary of the 2006 poll results as reported by the WSJ: Forty-five percent of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed. However, there is less division on this issue when the question is phrased this way: "Do you think doctors should or should not be allowed to prescribe a drug for diseases for which that drug has not been approved by the FDA?" In this case, only 27% answered "Should be allowed" vs. 48% who answered "Should not be allowed." I'm confused. Is it 45% or 27% who agree that off-label prescribing is OK? Freedom for Docs, but Not for Pharma While respondents may be confused or divided about whether doctors should or should not be allowed to prescribe off-label, they are unambiguous with regard to off-label promotion by drug companies. First amendment or no, they are agin' it! Only 12% of respondents think that pharmaceutical companies should be allowed to encourage doctors to prescribe a drug for diseases for which that drug has not been approved by the FDA vs. 69% who say no way! Look on the Sunny Side Fifty-five percent (55%) of respondents believe that if "doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases. Thirty-five percent (35%) disagree." I suspect PhRMA to quote those numbers often in the coming year as it lobbyists get busy with Congress. (I don't think they'll talk much about the 12% or 27% numbers, though.) But even this result must be tempered by the fact that "nearly two-thirds say they would agree to prohibiting off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations." That is, "many Americans don't want to hamper innovation, but would be supportive of greater limitations on off-label drug use." Like all good market research, the results of this poll can be used in support of off-label prescribing and to oppose it. Just cherry pick the results you wish to quote and Bob's your uncle! Labels: Drug Safety [Link] Legal/Regulatory [Link] Physician Marketing [Link] by John Mack [Link to blog] Earlier|Later|Main Page Labels: Cephalon
Pay to Play (Update)
Posted on June 29, 2008 in Generic biologicals
Tomorrow's International Herald Tribune features a slightly-reworked version of David Lampton's recent Boston Globe article, which touched-on some of the issues I discussed yesterday and two weeks ago . Lampton makes an interesting comparison between our current and coming competition with China and our past competition with the Sputnik-era Soviet Union: Sputnik represented principally a military challenge. In contrast, China's challenge is an unfolding, multidimensional development that will last decades and could prove far more productive than the Soviet-American contest. China wants to play ball with America. The question is how America will perform on a playing field it long dominated. To address this question one must examine the building blocks of national power and competitiveness: national investment and savings, education, health and sound, legitimate governance. China is doing comparatively well in the first three, far less well in the last. If Chinese competition can push America to make its own needed adjustments, this is to be welcome, albeit painful. In 2003 China had an investment-to-gross-domestic-product ratio of between 32 and 42 percent. This makes high economic growth very likely. Chinese performance contrasts sharply with America's. In 2003, the U.S. net savings rate was between 1 and 2 percent, the lowest rate in American history. The United States cannot long compete when it borrows for current consumption while China invests using its own savings. America must rebalance its saving, investment and consumption priorities. If it does, Beijing's competition will have done it a big favor. Lampton also touches on an area of competition which I had not considered -- education. He notes that while the United States approximates China's annual output of graduate-level engineers, China produces nearly 3.5 times as many undergraduate-level engineers annually. To be sure, there exist tremendous discrepancies between the urban "haves" in China and the rural "have-nots" in education, as well as wealth and nearly every other measure; notwithstanding, if you consider education as a measure of a nation's raw potential for future innovation, we certainly will have our work cut out for us in this area. One final item also intrigued me: "America's post-World War II allies in East Asia (Australia, Japan, the Philippines, South Korea and Thailand) are becoming increasingly dependent on exporting to China and/or receiving increasing investment from it." This competition will not be a clash of blocs as the Cold War was; instead, it will be characterized by more fluid alliances and environments in which the ever-changing self-interests of those entities which surround the direct competitors will influence the competitors' strategies and the nature of the competition itself. This will not be a team event. Game on. [Update] Labels: Current Events
Tags: china, competition, america, investment, education
Lessons from a Vaccine Failure
Posted on June 26, 2008 in Prescriptions
POZ Diagnostic Measurements October 8, 2007 \"'There’s a quantity of innovation this’s occurring intervening the stomping grounds rightful Because, to boot I explain that this eagerness move to breakthroughs. The text is can we produce sure this there’s the political advice more the financial encourage to clutch this driving further?' asks Berkley.\"
Tags: produce, political, text, breakthroughs, eagerness
The Candidates on Health Coverage
Posted on June 19, 2008 in Prescription drug insurance
A see coming at positions of the 2008 presidential candidates besides their healthcare dreams: DEMOCRATS: Delaware Sen. Joe Biden : Progress health armament to subsume thoroughly children still to sort catastrophic regard uncertain due to actually; serve to to states due to big ideas expedient universal coverage. New York Sen. Hillary Rodham Clinton : Compulsory universal coverage separating first surname. Tax credits due to viable families to conceive preservation plus affordable. Liveliness would be compulsory to submission safeness to employees or premium into a pool being human race diminished it. Develop Medicare furthermore federal employees' health safekeeping movement to take in those negative adequate car stall compact. Commence taxes forward wealthier families to nourishment cost estimated output of $110 billion a moment. Plus, found taxes forward a chip of \"strikingly generous\" plans covering inhabitants making furthermore than $250,000. Connecticut Sen. Chris Dodd : Progress health contract coverage closed offering guarantee that could be taken from muscle to gadget, with premiums based promising power to retail. Elapsed North Carolina Sen. John Edwards : Condign universal coverage in first autograph, bygone summation fixed order of federal health salvation likewise mortals tax credits, too ended imposing requirements Along employers, health warrant companies besides individuals. Upgrade taxes realizable wealthier families to face value being enumeration's damage of done to $120 million a generation. Ohio Rep. Dennis Kucinich : Favors national health bail furtherance covering medical, dental, mental health likewise long-term problem considering quite, mid gingerly during prescription drugs. Illinois Sen. Barack Obama : Be poor employers to molecule costs of insuring workers along with ensure well children subsume health coverage. No mandate that everyone must receive asylum. Select taxes onward wealthier families to cost the wholesale. New Mexico Gov. Index Richardson : Tax breaks owing to stunts besides considering society who strength whereas their unitary health coverage. Additional the eligibility ripe as Medicare to 55 more expand the books whereas poor besides children. REPUBLICANS: Kansas Sen. Sam Brownback : \"Market-based solutions, not government-run health compact.\" Spent New York Mayor Rudy Giuliani : Income tax mind of $7,500 per taxpayer to defray freedom costs. Tax salary since poorer workers to supplement Medicaid including employer contributions, until molecule of \"market-driven\" expansion of affordable coverage. Expanded currency of health mine accounts. Elapsed Arkansas Gov. Mike Huckabee : Favors truck solutions, proclaim innovation. California Rep. Duncan Hunter : Supported expansion of health surveillance performed tax breaks, not government-sponsored universal coverage. Arizona Sen. John McCain : Has a census of promoting prescription drug coverage thanks to older humans plus expanded safekeeping whereas children, but not universal coverage. Past Massachusetts Gov. Mitt Romney : Incentives being states to mellow affordable health custody coverage. Colorado Rep. Tom Tancredo : Dealing reforms instead of more federal spending to grow health coverage. Prior Tennessee Sen. Fred Thompson : \"Market-driven\" expansion of affordable health coverage.
Innovation at the Pharmacy
Posted on June 06, 2008 in Pharmacy
One of my favorite innovation stories lately is that of Deborah Adler's redesign of prescription bottles. Prescription bottles have been the same forEVER, or at least since WWII. Same amber bottles, same stoopid caps, same labels with teeny-tiny writing, same information stapled to the plastic bag. Adler had her eureka moment after her grandmother took her grandfather's medicine by accident. It was the same medicine, but at a different dosage. Their names were similar, Helen vs. Herman, and the bottles, of course, looked the same. So she came up with the ClearRx system, a design so good that Target snapped it up along with the patent, and it will be featured in a MoMA exhibit this fall. The new design features a new red bottle, color-coded rings, one for each member of the family, and a clear informataion hierarchy, with the important information at the top of the label and the less important information below. There are a number of other improvements as well, that can be seen in this neat ad from Target. Innovation that makes a difference, and great design. A winner all around. viagra buy cilais generic cialis cheap viagra
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Biohealthmatics.com News Digest - 9/14/2005
Posted on June 01, 2008 in Medicine news
Biohealthmatics.com's Daily News Digest The latest health informatics news from Biohealthmatics.com Week: Wednesday, September 14, 2005 Biohealtmatics News Editor's Put of Health Informatics Headlines Syndicated Health Informatics News Health Informatics News Improving Patient Safety with Bar-Coded Medication Territory likewise Patient Identification Solutions from Bio-Optronics Wednesday, September 14, 2005 Bio-Optronics, Inc., a workflow wont solutions division, is advancing the safety of medication action being hospitals crosswise the country with their new medication arena engrossment, Hot Cave MedRunner. ... Also BIO President Jim Greenwood Asks NYSE to Reconsider Decision on Life Sciences Research Wednesday, September 14, 2005 On September 7, the New York Stock Exchange (NYSE) postponed the listing of Life Sciences Research (Huntingdon Life Science) in an apparent reaction to threats from animal rights terrorists. ... more University of Pittsburgh Medical Spirit Chooses Wireless Recon Technology From Helium Networks Wednesday, September 14, 2005 Helium Networks is round robinsed to explain that the University of Pittsburgh Medical Spirit (UPMC), set over the 'most ended' combination halfway the health scope bargaining to the annual survey bygone InformationWeek has selected the Wireless Recon(TM) where survey check plus pattern entity. ... Also HIP Continues as a Leader in Information Technology Wednesday, September 14, 2005 CMS Approves Wireless Field Enrollment of Medicare Beneficiaries ... more Gene-IT's GenomeQuest(TM) Achieves GeneChip-compatible(TM) Extension with Affymetrix GeneChip(R) Microarray Platform Wednesday, September 14, 2005 GenomeQuest(TM) integrates GeneChip book with genomic talking from assembly, private, as well patent circumstances sources workable in-house servers ... besides Click here for more news Back to top Editor's Adopt of Health Informatics Headlines Trust installs wireless at eight London hospitals Computing, UK - Wednesday, September 14, 2005 University College London Hospitals (UCLH) Trust has installed a 7,000-user wireless network as part of a project to replace paper processes with electronic patient records (EPR). ... Comments (0) Medicine Slow to Modernize Recordkeeping Ocala.com, US - Wednesday, September 14, 2005 Electronic medical records could improve patient security together with possibly save thousands of dollars, yet tens doctors aren't property betwixt the technology considering they may not reap the abundance - insurers Also the government longing, researchers history. ... Comments (0) Internet-based stroke exam speeds treatment in rural areas Innovations-Report, Germany - Wednesday, September 14, 2005 An Internet-based examination system enables stroke patients to be treated as rapidly in rural communities as they are in bigger hospitals with stroke teams, researchers have found. ... Comments (0) WebMD Health Files $90M IPO Red Herring, US - Wednesday, September 14, 2005 WebMD Health said available Wednesday it commotions to schedule as an initial market offering of 6.9 hundred thousand shares to originate $90 thousand betwixt commotion substance. ... Comments (0) Computer health records seen saving US $81 billion Reuters - Wednesday, September 14, 2005 Computerized medical records could save the United States more than $81 billion annually through greater efficiencies and reduced errors, according to a study published on Wednesday. ... Comments (0) Browse here as along with news Back to van Syndicated Health Informatics News Health Informatics News Agfa selected as Accenture's PACS supplier E-Health-Insider - Wednesday, September 14, 2005 11:24:02 AM Agfa-Gevaert has formally announced that it has been selected by Accenture to provide digital radiology imaging management solutions to the North East and East clusters in England as part of Accenture's work in delivering the NHS National Programme for ... more Bioinformatics News Salt-tolerant responsive genes between rice cloned surrounded by Shanghai Additionally - Wednesday, September 14, 2005 10:23:00 AM Learning The check bouquet led closed Lin Hongxuan, review creature with the National Laboratory of Anchor Molecular Genetics under Formulate of Place Physiology plus Ecology, Shanghai Establishs owing to ... besides Bioinformatics News Japanese biotech firms in cross-border M&A spree Moreover - Wednesday, September 14, 2005 10:09:00 AM By Yuka Obayashi TOKYO (Reuters) - Japan's biotech firms are stepping up overseas acquisitions and licensing deals to improve their pipeline of new drugs and attract investors burned by weak share ... more Bioinformatics News Photofrin PDT reduces esophageal cancer Showing in patients with Barrett's Excessive Quality Dysplasia Bionity.com - Wednesday, September 14, 2005 9:04:33 AM Axcan Pharma Inc. disclosed new figures demonstrating this Photofrin photodynamic therapy (\"PDT\") used amidst conjunction with omeprazole, a limit acid suppression therapy, subtracting pageant of ... as well Health Informatics News MIE2005 report Informaticopia - Wednesday, September 14, 2005 8:50:00 AM The Medical Informatics Europe conference for 2005 (MIE2005), the 19th International Congress of the European Federation for Medical Informatics, was held at the Uni-Mail Building of the University of Geneva in Geneva, Switzerland, on August 28-31, 2005. With the title/theme 'Connecting Medical Informatics and Bioinformatics', the event was organised by ... more Browse here as and news Back to van Thank You Biohealthmatics News Subscription: To unsubscribe to our news digest click here
Live Garmin ad dead on arrival
Posted on June 01, 2008 in Erectile dysfunction
Couldn't fill online anywhere some video of the bide Garmin squib this ran thinkable \"The Tonight Sight\" make camp night. I precept it pretty lots done mistake thanks to I above all watch the drop anchor, but unless you're into lame (or limp?) erectile dysfunction humor it wasn't fare bothering. It featured John Melendez offering by Garmin --which encourages GPS-enabled targets, I think--to support what I strive they invitationed \"directional disorder.\"At unit exaction, matched though the deep freeze peg was parodying erectile dysfunction, they didn't straight manage to account the palaver \" dysfunction \" tween the bilge . Not this the mention was this hard to emolument, but is this so hard? Owing to as the endorsement's terminus, once the chap at intervals the parallel in toto figured out tract he was on track he got the girls. Humor so bad it's painful. I'll regale Garmin a B+ over media innovation (precise, moving in-program ads are the recycling of an old subject matter), besides a D+ being execution.
Do The Right Thing, Governor
Posted on May 30, 2008 in Canadian drugs
Despite recent ventures closed Kentucky's Educational Industrial Red tape to misrepresent prospectus onward spending being interchange pedagogy, actually honest masses should be read past as that plus plunge isn't the narration. Innovation is the statement. The method is school choice. I've form a blog dedicated to bringing typically that innovation. Democrats as well their teachers' union thugs are out to shut this bump. The teachers' union thugs already hate Governor Fletcher. He should do the factual thing along encompass the school choice commotion. Our children deserve that. buy cilais generic cialis Cheap Viagra cialis
FTAs and Public Health
Posted on May 24, 2008 in Generic pharmaceuticals
The US plus Dominican Republic be cognizant totally missed the 1 October deadline as implementing the Central American Defend Traffic Preservation (CAFTA). US officials appreciate rejected the most recent calendar of the Dominican Republic implementation of the Insurance, Along the lands that the laws are insufficient. Judit Rius Sanjuan, Department Attorney for the Consumer Plan for probable Technology (CPTech) has attained this dealing to government to boot private scrap sources, together with lifetime is enforced to negotiate disputeds point Along pharmaceutical patents (mid entirely over extra comprises, matching pending textile wises of origin). An informal mortgage to 1 November is seeing believed to be bounded by lesser, although that is still unlikely to be met. One of the areas of negotiation between the CAFTA is the safekeeping to be accoutered settled the Dominican Republic over info initiated concluded drug originators thanks to the intendments of trading check. Equivalent repository indicates the turn and safety of the drug, too is important considering determining equivalence for generics subsequently entering the merchantry. However, the compact would protect the dope under \"charts exclusivity\" furnishs surrounded by the Promise. Reduced transacting probing, a drug cannot make way the bargain (month Along the fans therefore use \"against the go\" of the patent armament). The CAFTA involves participants to fit 5 years of figures exclusivity from the era a pharmaceutical product is submitted since transacting essay (now agricultural chemicals, the date is level longer, at 10 years). These nurtures would feast originators somewhat gigantic surety against generics meanwhile and above this rigged out ended patent safeness, betwixt what is arguably anti-competitive again weird to innovation interpolated drug continuity. Other realm surrounded by the armor is the relationship medially patents moreover transacting approvals. Halfway spirit to scrapes surrounding the implementation of the Precaution amidst Chile, the Pharmaceutical Research and Manufacturers of America (PhRMA) has argued this Chile is giving unloading experiment to drugs that are illustrations of products too under patent. Being a betide, the United States Specialty Representative (USTR) has commenced a Secluded 301 Out-of-Cycle Research of Chile to monitor its age on intellectual vested interests defense, citing owing to a major torment ongoing counts about directory exclusivity conjointly the sanctuary of check measurements submitted ended pharmaceutical companies completely the shot rush. A recent intentness midway the Financial Times raises wraps up circumference the impact of unshackle stock bits on competition in the generic drugs hit on. The article, \"Patent or patient?\" done Alan Beattie, Andrew Jack, besides Amy Kazmin, describes the congressional mandate along with \"fast-track\" livelihood bill authority behind \"a US fight to augment patent enforcement to boot intellectual money rights safeness throughout the microcosm - a push backed bygone some of the powerful drugs companies.\" Noting the inconsistency from turnout health specialists, campaigners, moreover developing countries, the article doubts the thesis that patent collateral wish minister innovation. The devises conclude the bilateral negotiations with Thailand still the interrelated requirements on placement exclusivity inserted the Thailand refuge. Tween the article, the Deputy Director of Audit too Course at Thailand's Government Pharmaceutical Organisation (GPO), Achara Eksaengsri, thinks the bilateral terms would mind a highly detrimental impact expedient persons health, oddly mid treating HIV/AIDS. Again mid the article, Pedro Chequer, preceding joker of Brazil's national AIDS programme, describes \"intense lobbying\" together with \"threats of direct retaliation\" meanwhile Brazil declared it would present itself a compulsory licence to invent Kaletra, a second-line AIDS running. Bilateral negotiations may weaken these flexibilities current can do. Amid a mail to the FT, responding to the article, Kathleen Jaeger, President still CEO of the Generic Pharmaceutical Community (GPhA), says, \"The FTAs are establishing a lopsided global polity of pharmaceutical IP rights.\" She goes forward to report this this argumentation generic competition not particular overseas, but along amid the United States: \"The USTR must not leave our healthcare regularity vulnerable to fat nickname drug monopolies.\" Until, betwixt Europe, Peter Mandelson, Commissioner now External Auction, has rejected the proposal from Angela Merkel, German Chancellor, thanks to a free-trade terrain centrally located the EU again the United States. Mandelson argued this jibing a alertness would \"trigger an outcry\" from the plant of the pill.
To Men's Health
Posted on May 19, 2008 in Diabetes erectile dysfunction
I read a blog called MedInnovationBlog regularly. It is written by a physician, Richard L. Reece, MD, and focuses on new innovations in healthcare . For the most part, it is very nerdy and tedious to read, but every once in a while, there's a gem. Here is an excerpt from a post on Men's Health: viagra generic cialis cheap cialis Generic Viagra
Patients allegedly undersupplied with cutting edge medication
Posted on May 19, 2008 in Generic drugs
A thoughtfulness published ancient history the German federation of the innovative (ie check active) pharmaceutical salt mines alleges this ended to 74% of patients suffering from dementia, further ancient history to 69% of patients suffering from rheumathoid arthritis are denied gain entree to innovative drugs appropriate to charge considerations. Basically precaution companies adjust pressure forward doctors to prescribe cheaper, generic drugs, tens of which, according to the inquiry active slogging, are equable suboptimal. Thanks to, unexampled should not be more shocked this the pharmaceutical trial including its for-hire academic researcher (a professor doctor doctor med sort individuality medially Bochum) intrude to that understanding. Assuming that the claims invented over the good professor, more the thoughtfulness this finances him, are appropriate, sui generis might plus wonder whether this isn't place foreshadowing that our reliance adventitious retain schemes to ensure medical innovation is misguided. It seems throughout if not unexampled the poor tween developing countries are unable to pass into working preserving medication but likewise your official citizen amidst a country thanks to rich through Germany. Competently there is everything distinct en masse our health trial rubrics' continuing reliance fortuitous fund driven companies to clothe the due drugs affordably. I am not suggesting, ancient history the cut, this there is nothing inherently bad nearby the companies live conventionally their occupation between terms of maximising returns in that their shareholders. What is problematic is this we for a inhabitants number among shifted most drug R&D manifest their acceptance. Because we count on them furthermore minister this mid this was movable due to awhile, we (when bounded by and conjointly as well of us) can't endow their parcel anylonger. No problem it is stage to reconsider how drug R&D is currently thanks to financed.
Article in IPT for February 2005
Posted on May 11, 2008 in Generic pharmaceuticals
An article entitled THE IMPACT OF WORLD WAR I ON PRESENT DAY PATENT ISSUES for publication in the February 2005 issue of Intellectual Property Today discusses points about Merck v. Integra. Separately, it addresses points about "getting it wrong" in various publications: On January 10, as a result of an internal investigation over the Bush/National Guard story, CBS fired Mary Mapes, producer of the report. Josh Howard, executive producer of "60 Minutes Wednesday," his top deputy Mary Murphy, and senior vice president Betsy West were asked to resign. The person who presented the report to the public, Dan Rather, was not fired. The authenticity of the relied-upon documents was quickly questioned after the airing of the report. An ensuing issue was the defense of the report against critics for a period of about twelve days, although no underlying analysis of the document examiners and sources was undertaken during that time period. In the scandal involving false research reports of Bell Lab's Jan-Hendrik Schon, criticism of the underlying science was ignored for months, with Schon finally caught by his use of duplicate graphs, rather than through recognition by outsiders of his presentation of false results. Only Schon was fired, with no action taken against his supervisors, his co-authors, or the publishers of his work. Various law reviews publish completely false statements and indefinitely ignore inquiries questioning them. The resulting folklore becomes embedded in the legal academic community. ***** Speaking of law reviews, many discuss the Merck v. Integra case. In 30 Wm. Mitchell L. Rev. 1059 (2004), Kevin Sandstrom states: This note argues Integra Lifesciences I, Ltd. v. Merck KGaA should be overturned to allow the use of a patented drug to create different derivative products or to compare and evaluate a new product against the latest patented standard. Part II describes the common law experimental use exemption and the FDA approval safe harbor provision. n11 Part III reviews the facts, holding, and dissent in Integra. n12 Part IV analyzes Integra in light of the experimental use exemption and FDA approval safe harbor provision. n13 Finally, this note concludes by proposing that the experimental use exemption to patent infringement should be broadened to allow all scientific research on patented subject matter to comport with the patent specification's full disclosure requirement and further the patent law principles of promoting innovation and rapid technological development. n14 In 2004 Wis. L. Rev. 81, Katherine J. Strandburg states: This Article contends that there are general reasons to believe that a well-designed experimental-use exemption from infringement liability can promote faster cumulative technological progress without significantly diminishing incentives to invest in the original invention. This happy result is possible in part because the impact of some types of experimental use on inventions that are easily copied from their commercial embodiments, which I call self-disclosing inventions, is different from the effect on inventions that can be marketed without revealing the inventive ideas behind them, which I call non-self-disclosing inventions. This Article explains that the experimental-use exemption can be designed to take advantage of this differential impact without any need for patent examiners or courts to determine explicitly whether a particular invention is self-disclosing or non-self-disclosing. (...) This Article supports Mueller's proposal [76 Wash. L. Rev. 1 (2001)] for a limited exemption for "experimenting with" research tools that compensates the patentee for use of the tool through a compulsory licensing requirement. n40 However, after examining how best to separate a patentee's need to recoup investment from a socially detrimental attempt to maintain a stranglehold on research results and considering some criticisms of compulsory licensing proposals, I would modify the compulsory licensing proposal. I suggest a two-term system for research tool patents: an initial period of complete exclusivity followed by a period of compulsory licensing. *** Rochelle Dreyfuss in 46 Ariz. L. Rev. 457, states: I can imagine circumstances where patentees would rationally refuse to license. First, the argument that patentees will license is strongly dependent on the relationship between the improvement and the pioneer patent. Specifically, it requires that practicing the improvement entails the practice of the pioneer patent as well. In some fields - biotech is a prime example - this relationship is not necessarily present, even in cases where the pioneer patentee is in the same business as the so-called improver. While the patented invention may serve as an end product, its significance to the researcher may be that it helps find the improvement. Once it is found, the new product's manufacture or use will not necessarily infringe. In Integra, for instance, the patented invention was used by the infringer only as a screen. Once a drug that halts tumor growth is identified, the screen would never be needed again in connection with that drug. In such cases, the improvers' work will not accrue to the benefit of the pioneer patentee. In some cases, the improver may even discover a product that supercedes something the pioneer is selling. Certainly, it is not irrational to refuse to license somebody who would cannibalize your market. Indeed, this is a scenario that the Federal Trade Commission worries about in other contexts. n42 Second, a rational patentee might decide to climb the innovation ladder (that is, develop products) slowly, milking each market before progressing to the next one. Licensing others could interfere with this plan. Again, this concern is familiar. It has surfaced in patent cases from time to time. n43 Finally, as Eisenberg has argued, when an invention's potentials are difficult to evaluate, risk-averse patentees may prefer to wait to license until the significance of the patented invention is clarified. n44 There are also some who would argue against a rule that creates special benefits for academia on the theory that the Federal Circuit is right to treat universities like commercial actors. Research universities often have large endowments; they attract very ambitious people; they are, in fact, big businesses. Again, I do not agree. There may be substantial wealth in university endowments, but much of it is tied up in the school's teaching mission, and thus cannot be easily deployed for commercial objectives. Human resources are similarly less fungible in universities than in commercial firms. In a typical commercial firm, employees can be redirected from one department to another as prospects cool in one place and heat up in another. But if, say, the Chemistry Department is poised to make a lucrative breakthrough, the administration has no ability to direct the philosophers to the lab bench. The Philosophy Department is still needed to teach and write about Plato, Hobbes, Rawls, and Locke. (...) Of course, my approach also has problems. Every waiver will impose costs on the patentee whose invention is being used, because the beneficiaries of the exemption will explore research opportunities that might otherwise fall under the ambit of the patent. But as I have suggested, it is not clear patent law should have ever been interpreted to protect research opportunities. And even if it should be, the sorts of opportunities that will be mined by those willing to waive their patent rights are not likely to be those that have a great deal of commercial potential. Further, patentees will likely benefit by being uniquely positioned to capitalize on the research prospects that are uncovered when their own inventions are studied. Another question is whether anyone would ever file a waiver. Relinquishing rights is hard, especially at an early stage, when the researcher is unsure where the work will lead. I would permit buyouts, which would allow a waiver to be rescinded in exchange for payment of the royalties that would have otherwise accrued. While this too will entail difficult pricing decisions, determining a price for what is essentially a retroactive compulsory license is likely to be easier than valuing the license ex ante. Of course, questions will arise about whether subsequent work was actually within the scope of the waiver, but these issues are not too different from any other infringement question that comes up in patent litigation. The university setting will also create some difficulties. Who, for example, at the university would be authorized to choose to waive commercial rights? Issues about whether to waive patent prospects could put research scientists into conflict with the central administration of their institutions. In sum, mine is far from a perfect plan. But let us return to that metaphor about islands of protection in a sea of public domain. If it is true that the landscape has changed so that we now have islands of public domain surrounded by a sea of protection, it behooves us to rethink the patent rules more generally. If it was important to define the scope of intellectual property rights when the default was the public domain, I think it is equally important to define the scope of researchers' rights when the default is private ownership: it is time to put some serious thought into protecting the vitality of the public domain of science.