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Drugwonks
Latest News!Written By Comment Count Comment Last Three April 29, 2006
Peter Pitts
Finally, something we can really pin on the pharmaceutical industry … Annual deaths in U.S. drop in biggest decline in nearly 70 years Do I hear a call for Congressional hearing? -
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April 28, 2006
Peter Pitts
Did you see Bill Maher’s naive and unfunny op-ed in yesterday’s LA Times? Just incredulous. Check it out if you’ve got a strong stomach for stupidity and a few minutes to waste. Here’s the letter I just sent in to the LA Times editorial page in response … RE: “Pill Popper Nation,” April 27, 2006 To the editor: So now Bill Maher is a health care expert? His opinion piece was so full of errors and vitriol that I could write a treatise. But I will limit my comments to two of his absurdities. First, he characterizes the Citizen”s Petition submitted by the Coalition for Healthcare Communications as from “the drug lobby.” Not only is this not true, but PhRMA, the industry’s trade association, doesn’t even support it. Maher writes that the petition wants to “get rid of the warnings in drug ads.” Also wrong. The petition (which I helped to draft) calls for more user-friendly warnings. After all, warnings that people don’t understand don’t help advance the public health. But what really got my dander up was Mr. Maher’s libelous and mean comment that all the FDA does is “protect the profits of pharmaceutical companies.” This is an unfair, unearned, and unjust attack on the 10,000 overworked, underpaid —and exceptionally devoted staff of the FDA. When it comes to health care, Maher is less. Peter J. Pitts Pitts is Director of the Center for Medicine in the Public Interest and a former Associate Commissioner at the FDA -
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April 26, 2006
Peter Pitts
When I was at the FDA and we announced a new draft guidance on DTC print advertising, Dr. McClellan commented that when it came to the brief summary “less may indeed be more.” Today the agency is calling for more research into this issue — but solid metrics already exist. Right now, as we speak, the FDA possesses a broad body of high quality research that has been conducted on the brief summary — with protocols reviewed and commented on by the folks at DDMAC. The news item below is all well and good — but calling for more research is a poor excuse for lack of action on this important public health issue. (FYI — Inside the agency the brief summary is often derided as being like the Holy Roman Empire — it is neither brief nor a summary). FDA Will Survey Consumers on Brief Summary The FDA plans to survey consumers on the content and format of the brief summary in direct-to-consumer ads, according to an advance Federal Register notice released April 24. “In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements” because the detailed, technical prescription drug information geared toward physicians increasingly was used in ads for the public as a way for advertisers to fulfill the vague brief summary requirements, the notice states. The FDA plans to investigate the role of context in providing useful information to consumers, such as comparing consumer perceptions after viewing mock ads with risk information in chart or paragraph form. The agency also will study whether listing side effects and placebo rates of occurrence influences perception. Additionally, the FDA will survey the effectiveness of brief summary information provided in question-and-answer, highlights and drug facts formats. The agency will accept comments for 60 days after publication in the Federal Register under docket number 2006N-0133. -
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April 25, 2006
Peter Pitts
An unpublished letter by drugwonks commentator Ben Zycher. A loss to Washington Post readers — but a drugwonks.com bonus! To the Editor of the Washington Post, Shankar Vedantum’s article (“Comparison of Schizophrenia Drugs Often Favors Firm Funding Study,” April 12) misses the central reason that comparative drug tests funded by a given pharmaceutical producer usually report superiority for that producer’s drugs. The research and development process for new drugs aims to improve upon the clinical experience of existing treatments, which always are weak for some patients and for some of the many dimensions of such disorders as schizophrenia. To the extent that the research and development process is successful, studies conducted to determine whether or not the new treatments offer improvement for some patients in terms of some symptoms will find, quite honestly, that they do indeed. Moreover, no advertising or promotion of such new drugs may proceed until the data are reviewed and approved by the FDA. And the argument of some that studies funded by government systematically will yield unbiased comparisons is incorrect: The government has powerful incentives to promote certain (older) drugs, the use of which will reduce budget pressures. Pharmaceutical producers have profit incentives not to mislead themselves, and doctors and patients have strong reasons to find the most effective treatments. -
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April 25, 2006
Peter Pitts
Here’s a link to a new paper (by me) discussing how Europe can learn from America’s DTC experiences (both positive and otherwise) to create a more robust 21st century environment for patient empowerment. My premise is that health care communication is the consumer’s Rosetta Stone. Your thoughts and comments are much appreciated. -
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April 24, 2006
Peter Pitts
Such a revelation! GAO reports that the FDA can do better on post-market surveillance! The headlines and statements from Senator Grassley shout “OMG!” But those in the know remark, “Duh.” The issue, dear Senator must not begin and end with a press conference. (The headlines taste good, but 45 minutes later you’re hungry again.) The debate and road to amelioration must begin with more dollars and authority for the FDA. Senator, for the umteenth time — SHOW FDA THE MONEY! As for Dr. Goldberg’s comments below, ditto. -
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April 22, 2006
Dr. Robert Goldberg
Genetic tests that will screen people to see if they are high responders will be used in combo with proteomic or metabolomic tests to develop optimal doses and imaging markers to determine best response. Such work is already going on in cancer and with such drugs as Avastin. More on that later. -
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April 22, 2006
Dr. Robert Goldberg
Yesterday David Brailer, who leads the nation’s health IT efforts, announced he is stepping down from that post to spend more time with his family. Brailer has spent the last two years herding cats but also championing the need to get serious about investing in all forms of health IT. He helped created a vision and a critical mass as well as — dare I use the term — a tipping point towards the development of a framework in which health information becomes an important tool for improving health and preventing disease. We should thank him for a great job and for devoting his time and energy to public service.
http://news.ft.com/cms/s/8bd2bdb6-d094-11da-b160-0000779e2340,s01=1.html -
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April 21, 2006
Peter Pitts
According to the MIT Technology Review an international group of scientists has demonstrated a new tool for personalized medicine that makes it possible to predict nearly any adverse reaction an individual might have to drugs. Rather than being based on genetic screening, which up to now has been the dominant approach to personalized medicine, the new test relies on profiling an individual’s metabolic products. Called pharmaco-metabonomics, the technique involves screening urine for metabolite: small molecules that are involved in or produced by the metabolic processes that sustain an organism. Besides predicting adverse drug reactions, pharmaco-metabonomics also has the potential to determine more effective dose levels for each individual. “There is no genetic technique that can do that,” says Jeremy Nicholson of Imperial College London, the researcher who led the investigation. Here’s a link to the complete article: -
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April 21, 2006
Peter Pitts
On Thursday, Medicare officials released new statistics showing that 8.1 million people are now enrolled in stand-alone Medicare prescription drug plans, an increase of 1.7 million in the past four weeks. More than 30 million of the nation’s nearly 43 million Medicare recipients now receive some assistance in paying for their medications. -
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April 20, 2006
Peter Pitts
“Strike up the Klezmer and start acting like a man. You’re about to have a Truth Mitzvah.” — Steven Colbert According to a widely reported new paper, every psychiatric expert involved in writing the standard diagnostic criteria for disorders such as depression and schizophrenia has had financial ties to drug companies that sell medications for those illnesses. The American Psychiatric Association, which publishes the Diagnostic and Statistical Manual (DSM), said it is planning to require disclosure of the financial ties of experts who write the next edition of the manual — due around 2011. The manual carries vast influence over the practice of psychiatry in the United States and around the world. And that’s as it should be. Disclosure and transparency are, as Martha would say, “good things.” John Kane, an expert on schizophrenia who worked on the last edition, commented that, “It shouldn’t be assumed there is a true conflict of interest.” Kane said the report’s conclusions were driven only by science. “To me, a conflict of interest implies that someone’s judgment is going to be influenced by this relationship, and that is not necessarily the case.” Indeed. I guess Citizen Kane didn’t get the memo that explains why, if you are in any way associated with the pharmaceutical industry, you are guilty of crimes against humanity even if you’re innocent. And if you’re innocent you’re naive and are being used by the industry for its nefarious purposes. Witness the headline in the Washington Post, “Experts Defining Mental Disorders Are Linked to Drug Firms.” Can you say “leading the witness?” Steven Sharfstein, president of the American Psychiatric Association, said, “I am not surprised that the key people who participate have these kinds of relationships. They are the major researchers in the field, and are very much on the cutting edge, and will have some kind of relationship — but there should be full disclosure.” You bet. Disclosure. Disclosure. Disclosure. But here’s the question phrased differently — Why does the pharmaceutical industry only do business with the smartest minds in medicine? Answer: Because they are the smartest minds in medicine. The analysis could not determine the extent or timing of the financial ties because it relied on disclosures in journal publications and other venues that do not mention many details, said Sheldon Krimsky, a science policy specialist at Tufts University who also was an author of the new study. Whether the researchers received money before, during or after their service on the panel did not remove the ethical concern, he said. And, in the interest of transparency and disclosure, Mr. Krimsky is the author of the book “Science in the Private Interest,” so we certainly can guess at his general perspectives on the issue. Should professional relationships be disclosed? Most certainly. Should the best minds in medicine be recused from sharing their wisdom? Certainly not. -
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April 20, 2006
Dr. Robert Goldberg
Drugwonks.com is pleased to be part of a blogposium on Clinical Informatics, a neighborhood of folks with a passion to advance understanding on how bioinformatics and electronic patients records can improve health care. Jack Mason is the blogposium’s chair. He can be contacted at healthnex@gmail.com.
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April 20, 2006
Dr. Robert Goldberg
Yesterday the CDC reported that life expectancy rose faster and death rates declined faster last year than in the past 30 because of new medicines. This bodes well for those getting the Medicare drug benefit in record numbers. But meanwhile Families USA wants to shove seniors into a VA style plan that limits access to these new medicines. Limiting access to new drugs and keeping them off formulary is a form of rationing and way to keeping formulary closed, ,which itself is a bargaining tool for driving down drug costs. In fact a study by Columbia University’s Frank Lichtenberg shows that the VA drug lag has actually increased death rates and reduced life expectancy among seniors. This is what is going on in the UK by the way where breakthrough by breakthrough the government is finding ways to say no to drugs for cancer, Alzheimer’s, MS and diabetes that increase life expectancy and quality of wellbeing. The justification of the VA and UK are similarly and depressingly striking. Actually studies show that limiting access drives up total costs and makes seniors sicker. Why would Families USA want that? Perhaps their hatred of drug companies outweighs their concern for the lives of seniors. Ron “The Godfather” Pollack the Don of Families USA wants everyone to believe that the VA just hands the off formulary medicines like candy after a friendly sort of negotation. Not so. Even the non-formulary drugs have to be discounted by at least 40 percent or you can’t get them. Getting on the formulary costs even more. So if you are biotech company that makes no money what incentive do you have to even try? No wonder the VA drug lag is growing and seniors are suffering as a result. Imagine if this little drill was applied to Medicare as a whole just like the Godfather wants? -
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April 19, 2006
Peter Pitts
Yesterday the UK’s National Institute of Clinical Excellence (which goes by its Orwellian acronym of NICE) rejected Exubera (inhaled insulin) for NHS use on the grounds that the drug isn’t “cost-effective.” That means they don’t want to pay for it — not because it doesn’t work or it isn’t an advance — but because, well, they just don’t want to pay the additional 10 pounds (about $17.83) per week for those patients who would prefer inhaling rather than injecting their insulin. NICE’s dismissal of resultant savings from enhanced compliance and decreased complications? Total. Dr. Kate Lloyd, the UK medical director for Pfizer (Exubera is a Pfizer product) called the decision “perverse and short-sighted.” It’s refreshing to hear such a clear and unambiguous shot across the bow from a pharmaceutical company. Kiss me Kate. Not surprisingly Diabetes UK (the largest diabetes patient organization in Britain) is — no pun intended — up in arms. Says Simon O’Neill, their director of care and policy, “The government has put patient choice on the NHS agenda. Diabetes UK is disappointed that the (NICE) guidance on inhaled insulin does not reflect this as we believe it could offer an alternative treatment in improving the lives of some people with diabetes.” To which Dr. Andrea Sutcliffe (NICE’s deputy chief executive) responds, “The clinical experts we asked advised us that using injected insulin is not usually a concern for the majority of people with diabetes.” Well … what about a sizable minority? Once again we witness the victory of equality vs. quality — the hallmark of government-sponsored “universal health care.” If you believe in cost-based medicine (referred to most commonly in the US by the equally Orwellian moniker of “evidence-based medicine”), then this is what you get. And you better get used to it … or get involved in the debate. Prime Minister Blair admits that Britain’s health care is at a “crunch point,” but insists that the UK is still on an historic “end to traditional waiting” by 2008. Makes sense to me. Disallow all new treatments and I too would predict an historic end to waiting — as well as a permanent end to quality health care. Let’s not allow what’s going on “over there” go unrecognized over here. -
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April 19, 2006
Peter Pitts
Here’s an editorial from the Rocky Mountain News. That fresh mountain air certainly produces some clear-headed thinking. Don’t target ads in drug-buying bill Is Senate Bill 1 right for Colorado? If it did nothing more than let the state join a purchasing pool that cuts Medicaid drug spending, we would be inclined to say yes. But to again paraphrase the TV ads, SB 1 has some serious side effects. The most dangerous is an onerous disclosure provision that would force drug companies to spend money defending their advertising budgets rather than, say, producing life-saving treatments. If the disclosure requirement remains in SB 1, which is scheduled for a Senate vote today, we urge Gov. Bill Owens to veto the bill should it ever reach his desk. That would be an unfortunate necessity if proponents of SB 1 are right: They say the state could save $20 million of $170 million it is spending on Medicaid drugs this year. That may be an exaggeration. State health officials suggest the savings would be more like $3 million to $4 million. Still, that’s real money. Under the bill, the state department of health policy would join a purchasing pool with other states to buy drugs for Medicaid recipients. People who earn too much to get Medicaid (up to $50,000 for a four-person household) but do not have medical insurance or whose policies do not pay for prescriptions could join the pool for $25 a year and purchase drugs at the discounted rate. We supported a somewhat similar bill last year that Owens vetoed. We oppose SB 1, however, because of its inexplicable disclosure requirements, which could have been written by Ralph Nader. Asserting that advertising and lobbying leads to “an inordinate and unnecessary escalation of the cost of prescription drugs to consumers,” the bill would force every pharmaceutical company to detail its marketing budget to the state. Every year, each drug maker would have to list promotions directed toward “any physician, medical student, hospital, nursing home, pharmacist, health benefit plan,” etc. We’re guessing that would include an accounting for the pens pharmaceutical reps hand out to receptionists. They would also have to report all gifts worth more than $50, and naturally, how much they spend on lobbying, and who got the money. Why? The Naderite left has long claimed that recent advances in medical science are mainly an illusion. Instead, drug companies largely repackage similar formulations and use promotional gimmicks to hoodwink doctors into prescribing new medications their patients don’t need. Tell that to the arthritis patient who lives a relatively normal life because she can take Celebrex rather than megadoses of aspirin, or the diabetes sufferer who can test his own blood sugar with a pocket monitor. Besides, if drug makers were forced to satisfy elaborate disclosure mandates, that would divert their focus from healing people — which is why, in its current form, SB 1 offers the wrong diagnosis. -
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April 19, 2006
Dr. Robert Goldberg
I gave out the wrong address to the new medical news media watch website… It is www.healthnewsreview.org I apologize for confusing people more than I usually do. Thanks to Antoine Clarke for picking up the boo-boo. The link to the Health news review rating of the CBS news treatment of the Evista study is posted below as is the review itself. As I noted in my last post, I think their review underscores the need for the oncology community to get on with the job of tailoring treatments according to how well people respond to certain cancer drugs. I have included an article that deals specifically with tamoxifen and other estrogen modifying agents and pharmacogenomics below. http://www.healthnewsreview.org/review/review.php?rid=303 This story reports on a potentially important development in the prevention of breast cancer among high risk, postmenopausal women. The story is clear that this is an existing drug for osteoporosis that has not been approved by the FDA for use in breast cancer prevention. The story also does not make claims about when it may be approved for that purpose. There is no obvious disease mongering; the story accurately represents the prevalence and seriousness of breast cancer Although there is mention of a clinical trial, the story does not describe the study design. Also not mentioned was the fact that the results have not yet been published or peer reviewed, so interpretation of the clinical significance of these results are difficult at this time. Benefits of treatment are quantified in relative terms only. The viewer is told that raloxifene and tamoxifen both reduce the incidence of breast cancer by about 50%, however there is no context provided for these numbers. Most viewers would want to know “50% of what?” They want the absolute risk reduction. Viewers should have been told that even though the women in the study were high risk, the incidence of breast cancer over 5 years was still very low. The story also does not mention that raloxifene does not reduce the incidence of ductal carcinoma in situ (DCIS, which tamoxifen does), so it is not clear that when the story says the benefits are equivalent between the two drugs, if it will hold true if they include all breast cancer events (including DCIS, which is found quite commonly these days). The story also omits an important fact: the decrease in incidence of uterine cancer and clots in the raloxifene group was not statistically different from the tamoxifen group. Although uterine cancer and blood clots are mentioned as harms of treatment, there is no mention of how often they occur. Other harms such as cataracts and stroke are not mentioned. No costs are mentioned. According to the website for the STAR trial, the cost of Raloxifene is about $75 per month, while Tamoxifen costs about $100 per month. Because these drugs have to be taken for long periods of time, cost is an important issue. -
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April 18, 2006
Peter Pitts
I should also point out, in light of all the positive media surrounding the STAR study, the absurdity of Lilly having had to cop a plea and pay a $36,000,000 fine (“equitable disgourgement” indeed!) for allegedly disseminating information about the utility of Raloxifene “too soon.” Too soon? For whom? Certainly not for patients, their spouses, children, extended families and friends. Certainly not for … doctors? In the meantime, those who don’t find out about this important information today — or remember it for the year or so it’ll take for the supplemental application to be approved — won’t have the benefit of this very important (let alone newsworthy) information. Something to ponder next time a pundit or politician pontificates on the need to further restrict the communication of health care information. -
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April 17, 2006
Peter Pitts
The big news today is that a federal judge ordered the Food and Drug Administration to rule on a human growth hormone product made by a Novartis AG unit, adding pressure for the agency to deal with the high-stakes question of generic copies of biotechnology drugs. The decision by Ricardo M. Urbina, a judge in the U.S. District Court for the District of Columbia, came in response to a suit filed by Sandoz, a generics unit of Novartis, a Swiss pharmaceuticals maker. The suit, which named top officials of the FDA and its parent agency, the Department of Health and Human Services, alleged that the agency violated federal law by failing to either approve or reject Sandoz’s July 2003 application to market Omnitrope, a version of human growth hormone. The judge’s opinion issued today — saying the agency is required to meet a statutory deadline in its decisions on whether to approve drugs — could strengthen the hands of drug companies. Judge Urbina wrote that the FDA had “identified no compelling reason for this court to excuse its delay.” Silence, it seems, is not always golden. Sandoz’s application “remains stuck in the ether,” the judge wrote, citing the “egregiousness of the delay.” The opinion says the FDA must meet statutory requirements, which include the option of giving the company a hearing before the Secretary of Health and Human Services about whether its drug is approvable. The moral of the story is that delay based on silence doesn’t wash. Nor should it. Silence is the excuse of a weak argument. However, delay based on lack of expertise is a very good reason to defer a decision. Since Judge Urbina offered a hearing before the Secretary as a remedy, I predict that is precisely what will be offered. Who wins? You make the call. -
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April 17, 2006
Dr. Robert Goldberg
“Americans United” is a labor and Democrat party funded front group and they are wrong on the facts to boot. Why is there no caveat about where they get their funding at the end of their editorial in today’s USA Today? (See below.) The design of the drug plan is exactly the same as that designed by President Clinton and supported by Families USA and the Democrats in 1999. How do they explain being for the drug plan before being against it? As for officials not wanting you to know about the enrollment breakdown, it’s right there on the damn HHS website, press release, etc. You would have to be an idiot not to see it … or Brad Woodhouse. Actually there were 11 million seniors that lacked drug coverage before the program and 8.3 million have voluntarily signed up. My math puts me at 75 percent and we are not at May 15. 70 percent have reaped savings. that’s another way of saying 30 percent have not yet. As for the donut hole, guess what, a large chunk of seniors won’t hit it and those that will have actually purchased coverage that fills it.
17 April 2006 USA Today - By Brad Woodhouse The Medicare prescription drug program is costly, confusing and corrupt, and it has left millions of Americans to conclude that President Bush and Congress designed the plan with pharmaceutical and health insurance companies in mind, not seniors. Medicare Part D is so hopelessly flawed that the enrollment deadline of May 15 must be extended to give Congress time to fix this debacle. The deadline also must be extended to give people more time to sign up without penalty. It would be immoral to penalize seniors and the disabled for their failure to sign up for a plan that should have never been this difficult and confusing in the first place. The Bush Administration claims that roughly 29 million Americans of the 42 million who are eligible have enrolled. What officials don’t want you to know is that almost three-quarters of those enrolled — some 21 million Americans — were dumped into Part D automatically. Only about half of those eligible for Part D who can voluntarily enroll have done so. The reasons are clear: cost and confusion. A recent Washington Post/ABC News poll found that more than one in every three Americans who have enrolled reported that they have realized no savings — and when many begin to fall into the infamous “doughnut hole,” that figure is sure to rise. In addition, millions of Americans have been deterred from enrolling because of the maze of confusion that has been a staple of the prescription drug plan. With more than 500 plans nationally, each with different premiums, co-pays and formularies — all of which are subject to change — it is little wonder that so many have yet signed up. The fatal flaw in this law is that it prohibits Medicare from negotiating with pharmaceutical companies for lower prices, and from eliminating confusion by offering a simple and affordable plan to seniors directly from Medicare. The deadline must be extended so more people can sign up and so Congress can fix Part D to make it simple, affordable and guaranteed. Brad Woodhouse is communications director for Americans United, an advocacy organization based in Washington -
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April 16, 2006
Dr. Robert Goldberg
The amount of conservative complaining about Governor Romney’s health care plan has been nothing short of amazing to me. If you replace the words “health care” in the bill with “Medicare Part D” or “Medicare Advantage” you would have the same sort of vehicle for expanding coverage and promoting competition. Sure, there are things not to like about the Romney plan, including the employer fine and things it does not do, like provide enough low cost, non community rating choices. But how about fighting to fix those? As for the whining that it will be a model elsewhere, how about building our own models? Finally, conservatives need some to educate themselves about what will really save health care dollars or at least make them more valuable. Health care financing models are only means to an end. The tidal wave of retirement needs to be reversed or transformed by enhancing health or prolonging productivity. Better health and longer life through more personalized medicine and preventive technologies are the key to revolutionizing health care. We need to start talking about and developing approaches that reward and capture these innovations. And we need both the guts and brains to carry the fight through or just get out of the way. It’s easy to gripe, hard to lead, harder to win. -
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