About CMPICenter for Medicine in the Public Interest is a non-partisan, non-profit educational charity. The Mission of CMPI is to discuss, debate and demonstrate how exponential and accelerating technological progress coupled with smart public policy will enhance and advance 21st Century health care by predicting, preventing, diagnosing, and treating diseases with greater speed, more precision and less cost.Related Blogsfightingdiseases.orgCNEhealth.org RX Daily Dose Gooznews Medpundit Medrants Quackwatch CA Medicine man Biotech Blog Health Care for All Pharmablogger Instapundit Powerline Club For Growth Washington Monthly Hugh Hewitt Little Green Footballs Polipundit Real Clear Politics Kaus Files National Review Town Hall Opinion Journal Nurses For Reform Nurses For Reform Blog Media Research Center Newsbusters Internet Drug News Pharmalot AHRP BrandweekNRX EyeOnFDA Healthy Skepticism KevinMD OnPharma Orange Book Peter Rost Pharmagossip Pharma Marketing Blog PharmaRag Shark Report TortsProf StateHouseCall.org The Cycle CMPI Podcasts What's an Adverse Event? ArchivesLast 400 postsFull Archive coming soon! CategoriesCategory search coming soon! |
blog May 16 2008 | Robert Goldberg www.macleans.ca/science/health/article.jsp 0 Comments May 16 2008 | Peter Pitts Speaking of DTC, here's what I had to share with Mike Schneider on Bloomberg TV: vimeo.com/1020779 Speaking to an FDA advisory committee is one thing, speaking to the American public --the ultimate advisory committee -- is something else entirely. (And the latter is more intimidating.) 0 Comments May 15 2008 | Peter Pitts The second half of Day One was all about what the FDA is doing to help spread the message of safety/efficacy -- with a particular focus on the issue of "safe use" of drugs. Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER). They all presented their terrific work. All the more so considering the shoe-string budgets under which they operate. But what does any of this have to do with DTC and under-served communities? Let's just say it's tangential. But (and not surprisingly) it really caught the attention of the committee. Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep. Danger, Will Robinson, danger. Day One closed with "Committee Discussion." Some nutty. Some really useful. Some examples: * A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts. * The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA"). Good idea. * A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry. Yes, industry. A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea. * And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced." And my other favorite, that DDMAC should pre-review "media placements." At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information. Onwards to Day Two and a stimulating conversation on 800 numbers for television ads. 0 Comments May 15 2008 | Peter Pitts To spice up my testimony, I enlisted help from Samuel Johnson, Juvenal, Woody Allen , and W. Edwards Deming. In closing, I urged the committee to ponder this question posed by T.S. Eliot: "Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information? Is anybody listening? 0 Comments May 15 2008 | Peter Pitts Andreas Lord, of Eastern Research Group, presented a lit search of studies done relative to DTC issues and the "under-served" populations discussed in FDAAA. Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary." The recommendations of the committee -- more research. Very helpful. This hearing is beginning to be like treading water in treacle. 0 Comments May 15 2008 | Peter Pitts Only two people offered public comment. One was a woman talking about advertising for atypical antipsychotics. The other was me. The buzz among the press corps was "where's pharma?" Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket). He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck." I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future. 0 Comments May 15 2008 | Peter Pitts Blogging to you live from the FDA's Risk Communications Advisory Committee. I will post the days complete musings later this evening, but for now here's a taste of the action: Kristin Daivs (Deputy Director, DDMAC) made a very good presentation on what FDAAA asks FDA to do vis-a-vis "at risk groups" (specifically on "under-served" communities -- minorities, the elderly, socio-economic populations, etc.). She did a nice job -- but the real action was during the Q&A. One item worth repeating was one panelists request that DDMAC make available to the committee a case study of how DDMAC dealt with an actual marketing campaign. Not an unfair request -- except that correspondence between DDMAC and a company requesting pre-review (and all of the ensuing back-and forth) is commercial confidential. Kristin then said, "I'd make a plea to the industry to supply these case studies." Amen. Now let's see who will step up to the plate. She was also asked "why DDMAC takes so long to issue fewer and fewer letters." Politely, she let it be known that the question is both wrong and simplistic. Go get 'em Kristin. I guess that means she's off Mr. Waxman's Christmas card list. During the break, someone suggested that DDMAC should publish metrics that report on the increased volume of pre-review required of DDMAC. After all, if you can't measure it -- it doesn't count, right? Stay tuned. 0 Comments May 14 2008 | Peter Pitts Very pleased to announce the launch of "The Patient," the new benchmark journal for peer-reviewed authoritative and practical articles on the application of pharmacoeconomics and quality-of-life assessment to optimum drug therapy and health outcomes. According to the publisher (Wolters Kluwer Health), The Patient is "an invaluable source of applied pharmacoeconomic original research and educational material for the healthcare decision maker. The journal is dedicated to the clear communication of complex pharmacoeconomic issues related to patient care and drug utilization." Here's a link to the magazine's website John Bridges (Johns Hopkins School of Public Health and Senior Fellow, Center for Medicine in the Public Interest) is the journal's lead editor. (And, in the interest of full disclosure, I am on the editorial board.) Here is a link to the magazine's website: http://thepatient.adisonline.com We welcome this important new voice to the debate. 0 Comments May 14 2008 | Robert Goldberg Raising premiums and squeezing providers...that will just put HMOs on the political hot seat again. Ultimately the health care decisions and dollars will have to flow doctors and patients and the real solution will be found in technologies based on underlying mechanisms of disease.. washingtontimes.com/apps/pbcs.dll/article 0 Comments May 13 2008 | Peter Pitts 0 Comments May 12 2008 | Peter Pitts Very thoughtful and appropriately provocative editorial in the May issue of Nature, "Nothing to see here." Here's how it begins: "The Journal of the American Medical Association (JAMA) played a considerable part in manufacturing media outrage last month over an article revealing Merck's use of ghostwriters and rubber stamp experts in the preparation of clinical research articles on Vioxx (rofecoxib). Although the JAMA article (299, 1800-1812, 2008) revealed nothing new about the ghostwriting practice and so-called guest authorship, the JAMA editors nevertheless felt moved to introduce a new, stricter set of policies on authorship and conflicts of interest." Here's the complete editorial from Nature: Click Here to Download And here's how the editors of Nature conclude their essay: "But the editors of JAMA and other journals would do well to focus on content, not process. JAMA's attack casts a cloud over the entire industry. Stigmatizing any paper that comes from the private sector on the basis of an analysis of one company's poor publishing practices over five years ago is not only unjustified, it is discrimination pure and simple." 0 Comments May 12 2008 | Robert Goldberg First, more on the context behind the Brownlee-Lenzer attack on Peter Pitts and Fred Goodwin. I have written about how the two failed to reveal their bias against SSRIs in their previous selective reporting. This is relevant since the point of the article Peter and I wrote in the Washington Times "Tabloid Medicine" was precisely about such one-sided coverage about how SSRIs "caused" or were "linked" to suicides. Turns out that they are, but not in the way people like Brownlee and Lenzer had reported: the decline in SSRI prescribing that fear mongering contributed is associated with an increase in suicides. Now comes word from the exec producer of the Infinite Mind that Lenzer pitched a segment about so-called hidden corporate ties in reporting, which was rejected, before running the Slate piece. "....In the interest of full disclosure, I also should note for the record that Lenzer, who co-authored the Slate article, called me a few days after the "Prozac Nation: Revisited" program aired to pitch a program that she wanted us to do for The Infinite Mind, called "Journalists on Prozac," which would feature her and her writing partner Shannon Brownlee. Checking into Lenzer's credentials, I found a troubling article in The New York Times taking her to task for a British Medical Journal article that suggested that Eli Lilly and Company, which makes Prozac, had concealed documents about the link between anti-depressants, suicide and violence. The BMJ subsequently retracted the article, with full apologies, and the whole matter was widely covered in the news media. After we told Jeanne Lenzer that we would not be proceeding with a program featuring her, she and Brownlee wrote the article for Slate." fray.slate.com/discuss/forums/thread/1237086.aspx (Lichtenstein also notes that he did not ask Peter about his working for Manning, Selvage and Lee.) On another front, and speaking of fronts, the Prescription Project has released “Toolkits to Guide Hospitals and Medical Schools with Conflicts of Interest” The guides follow the same flow as the recommendations coming out of the AAMC taskforce. . From the titles of the tool kit modules along with the recommendations in the tool kit it appears that they had significant time to digest the AAMC recommendations and take them several steps further to advance their cause (this to be expected). www.policymed.com/2008/04/aamc-and-prescr.html You can see where this is heading ultimately. Small bites at private sector innovation until nothing is left.
0 Comments May 12 2008 | Peter Pitts Here are some excerpts from Bob Goldberg's excellent piece in today's edition of The Washington Times, "Health Care Realities" ... Ah, the rites of spring! Baseball, cherry blossoms and the annual report of the Medicare trustees, who duly report that Medicare is going broke. Yet each year we have the routine response of politicians and pundits who wring their hands about the unsustainable rate of growth in health care expenditures. Here's a typical comment: "Despite a massive increase in health expenditures together with a marked expansion in health workers over the past decade, the nation's health has improved less than expected. The benefits have not appeared to justify the costs. ... We have emphasized high-cost, hospital-based technologies " a situation " made all the more serious by the lack of emphasis on prevention of disease." Those observations were not made yesterday. They were made by Dr. John Knowles in a book titled "Doing Better and Feeling Worse: Health in the It is useful to look back to see far how we have come even as some things stay the same. In 1974, cardiovascular disease was the cause of 39 percent of all deaths. Today it is about 25 percent. Cerebrovascular diseases were responsible for 11 percent of deaths back then. In 2004 they caused 6.3 percent of deaths. Kidney diseases were linked to 10.4 percent of deaths and now they are associated with 1.8 percent. Of course, the longer people live the more likely they are to die from cancer or Alzheimer's. The percentages of deaths attributed to influenza and pneumonia have remained almost constant, as have the percentages of people dying from respiratory diseases. As As the genetic variations that predict our risk of disease and response to treatment are translated into tests and treatment, the waste from trial and error or unproductive intervention will fall as well. But there is a lot we can do without much effort to save money and improve health. More prevention, shifting care to lower-cost settings and rewarding people for healthier living can move us forward. That's not a crisis; that's an opportunity. Here's a link to the complete op-ed: 0 Comments May 12 2008 | Peter Pitts Have you noticed that we're not hearing folks in Washington, DC ask this question any more? The Lancet 2008; 371:1551 DOI:10.1016/S0140-6736(08)60663-7 Editorial Combating counterfeit drugs Last week, the US Food and Drug Administration (FDA) told a Congressional hearing that it believes a contaminant found in batches of heparin, which have killed at least 81 patients, might have been deliberately added. The source of the contaminant—oversulfated chondroitin sulphate—has been traced back to a Chinese supplier of drug manufacturer Baxter International. Why the stocks might have been intentionally contaminated is unclear, but the fact that oversulfated chondroitin sulphate is structurally similar to heparin but about 100 times cheaper, raises the very real possibility that it could have been added by counterfeiters. If counterfeiting is behind the heparin case, it would not be that surprising; trends indicate that counterfeit medicines, defined by WHO as drugs that have “been deliberately and fraudulently mislabelled with respect to identity and/or source”, are a growing, global problem. The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing countries, where drug regulatory systems can be weak or non-existent, around 10–30% of medicines might be counterfeit. Antimalarials have been a particular target for counterfeiters, and fakes have flooded the market in many Asian countries. The substances used to adulterate medicines can vary from chalk, to antibiotics, to highly lethal substances that cause alarming spikes in mortality rates. Subtherapeutic levels of the genuine medicine, such as an antimalarial, can also lead to death or the development of fatal drug resistance. But these deaths, mainly in developing countries, are largely hidden in public-health statistics. This situation is only likely to worsen as counterfeit drugs are becoming more difficult to combat. Criminals are using more sophisticated techniques to bypass standard laboratory testing such as the addition of cheaper substances that mimic genuine drugs. Holograms on drug packaging, designed to make counterfeiting more difficult, are also being copied with increasing accuracy making boxes of fake products hard to detect by the human eye. These deceptive measures have unfortunately led to a booming, lucrative trade. The Center for Medicine and the Public Interest estimates the sales of counterfeit drugs will reach US$75 billion in 2010. So what is being done to address the problem? At the international level, the World Health Assembly adopted a resolution against counterfeit and substandard drugs in 1988, and at the end of 2006, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) was set up by WHO to mobilise action. However, despite these moves, few concrete steps have been taken by countries and political will to adopt anti-counterfeiting measures is lacking. Most WHO member states are doing a poor job of reporting counterfeiting cases. Incredibly, between 2002 and 2004, WHO received no reports of counterfeit drugs. In many countries, counterfeiting medicines is not even considered a crime and when it is, the penalties for those found guilty often do not tally with the severity of the action. For example, in the UK, the prison sentence and fine for counterfeiting a T-shirt with a trademarked logo can be greater than for counterfeiting a medicine. Tougher prison sentences and heftier fines need to be introduced by governments to deter counterfeiters. Countries must also strengthen their ability to regulate the drug supply. According to WHO, only 20% of its member states have well-developed drug regulatory systems, and around 30% have no or weak drug regulation. Twinning food and drug authorities in rich countries with ones in resource-poor countries might help nations that are struggling to regulate the market. Drug authorities also need to work effectively with customs, the police, scientists, health workers, WHO, and INTERPOL. This type of collaborative approach has proved successful in tackling counterfeit antimalarials in southeast Asia. The pharmaceutical industry also has its part to play. It should be legally required to report suspected cases of counterfeiting to the relevant national drug authority—a practice which is currently voluntary. Companies must also be encouraged to lower the prices of their products in developing countries to reduce the economic incentive for counterfeiters. There is no magic bullet to deal with counterfeit medicines. Countries need to adopt multipronged, multidicisplinary approaches to combat the problem. WHO and donor countries should provide support to developing nations to strengthen their drug regulatory systems. But individual governmental commitment to this goal is essential. Without it, public safety will continue to be compromised. 0 Comments May 09 2008 | Peter Pitts Per yesterday’s E&C Subcommittee on Oversight and Investigations "Direct to Consumer Advertising: Marketing, Education or Deception?" hearing (aka: “MED Ed”), some of the remarks offered by James T. Sage (Pfizer’s Senior Director/Team Leader for Lipitor): 0 Comments May 09 2008 | Peter Pitts According to our buddy David Lepay, the FDA's senior advisor for clinical science, the agency and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards (IRBs), the first of the FDA’s efforts to issue regulations instead of guidances for clinical trials. Existing FDA regulations do not take into account all the different types of organizations — vendors, co-investigators, site management organizations and contract research organizations — involved in conducting clinical trials. FDA regulations fail to account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms. “We are working with groups within and outside the FDA to address this,” Lepay said at the annual conference of the Association of Clinical Research Professionals. The FDA also is working to improve its internal processes to address “why it takes so long to disqualify clinical investigators” caught in wrongdoing, Lepay said. Recently, U.S. Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.) asked the Government Accountability Office to examine why the agency has been so slow to discipline investigators. It's not a question of doing it fast. It's a question of doing it right. 0 Comments May 08 2008 | Peter Pitts Senator Kohl has assured that $275 million in additional funding for FDA will be included in the Senate version of the FY 2008 emergency supplemental bill. The Senate Appropriations Committee mark-up is scheduled for next week. The fate of the Kohl amendment is likely to be decided, in part, by House and Senate leadership when they determine the extent to which final Congressional legislation will fund programs other than defense and the war effort. We'll see. 0 Comments May 08 2008 | Robert Goldberg Apparently Shannon Brownlee buys into the Tom Cruise notion of mental illness, that it is some mystery or perhaps (my inference with no basis) a Thetan induced stated of disturbance. Here's Ms. Brownlee 'splaining what depression and manic depression is really all about... "The mind and its illnesses remain as mysterious as the cosmos.." Meanwhile, all scientists did was support the drug companies in developing medicines that were based on a flimsy excuse to abandon Freud. Shannon again: "It's not as if physicians can administer a blood test to determine if a patient is depressed or anxious or obsessive-compulsive. Rather, psychiatry defines -- and diagnoses -- psychiatric disorders on the basis of subjective symptoms that are reported by patients or observed by doctors." Right, and there are no blood tests for Alzheimer's, Parkinson's, MS, dementia, cerebral palsy or schizophrenia...so I guess there aren't real diseases either... Brownlee then crosses the Neutral Zone and into Scientology territory... "The notion that depression is a biological ailment, like Alzheimer's, proved enormously appealing to patients. It relieved much of the stigma of mental illness, which could now be viewed not as a personal or moral failing, but as a glitch of biology. The serotonin theory also appealed to the medical community, for a slightly different reason. It made the mind seem more knowable, less like a black box, and psychiatry seem more like real science, instead of a lot of Freudian talk about repression and sex. Psychiatrists could now say to patients, you are sick because of a deficiency, and these drugs will restore you to normalcy and mental health. If only psychiatric disease were that simple. In reality, there is little research to show that being a quart low on serotonin leads to depression, and even less to suggest that patients who commit suicide have lower levels of serotonin than normal people. And nobody really knows what SSRIs actually do in the human brain." This is called ignorance by choice. So of course the marketing and prescribing of drugs to people who don't need will lead to horrible events like death, anxiety, etc. But Brownlee and the Scientology types beg a question: if mental illness is not biological in nature, and we know so little about serotonin and other neurotransmitters, how would drugs that can't restore people to health then harm so many? Sorry, I am interrupting her rant: "What's more likely is that the field of psychiatry, with its shifting, subjective diagnostic categories and its enthusiasm for new drugs, has been acutely vulnerable to "disease mongering." This is the increasingly common practice on the part of the pharmaceutical industry to broaden the perceived market for a drug by persuading doctors and the public that huge numbers of people suffer from this or that disorder. Between disease mongering and some doctors handing out SSRIs like Pez, antidepressant prescriptions for children have surged 27 percent since the mid-1990s. Today, between 1 million and 3 million kids under the age of 19 are on one or more of these drugs for diagnoses ranging from attention deficit disorder to migraines to schizophrenia. Taking SSRIs has become so commonplace that young people talk casually about needing to "adjust their meds" in response to a rough week at school or a bad breakup. Meanwhile, doctors have been prescribing these medications without knowing until just recently that, according to the FDA, 2 to 3 percent of their young patients could be at risk for drug-induced suicidal thoughts or actions. Maybe that's because academic psychiatry has been too busy performing research with a very different agenda to answer the fundamental questions. In their haste to partake of industry research funds and other perks, academic researchers have focused much of their effort on what Carroll calls "experimercials" -- studies aimed at expanding the drugs' "off-label," or unapproved, markets. And so doctors still can't tell which patients are most likely to benefit from taking an SSRI. Nor can they predict which ones are most likely to suffer devastating reactions. They still don't have any idea how, biochemically, the drugs might trigger suicide and bipolar disorder. In his book "Let Them Eat Prozac," psychiatrist Healy writes that the story of the SSRIs "reveals a lack of research so complete that academics cannot avoid questions about how well the health science research community serves us." PS David Healy is a paid expert witness for trial attorneys. Something Brownlee never mentions... Add her bias against using medicines to treat mental illness, indeed her belief that mental illness is just a marketing gimmick, you might understand why she and Jeanne (I stole the documents) Lenzer who openly collaborated with Peter Breggin (who has his own ties to Scientology) would attack Fred Goodwin and Peter. Like I said, context matters. And there is a lot more of it to come. paxilprogress.org/forums/showthread.php 0 Comments May 08 2008 | Peter Pitts Today's House hearing on pharmaceutical DTC goes forward under the title,"Direct to Consumer Advertising: Marketing, Education or Deception?" Let's just call it MED Ed. The prosecution (yes, because it's really a show trial) is led by Representative Bart Stupak (D, MI). Nuff said. The real action (meaning where real and meaningful conversations will take place on this issue) takes place later this month when the FDA advisory committee on risk communications meets to discuss DTC and how it can be made better. That's the right way to do things. As far as today's hearing being good theater, my advice is to go see Ironman. (Per full disclosure, neither www.drugwonks.com nor www.cmpi.org receives any funding from Marvel Comics.) 0 Comments May 08 2008 | Peter Pitts Gov. David Paterson inherited a $4.4 billion budget deficit. To close part of it, state Assembly members put public health on the chopping block when they passed the budget last month. Of course, they promised that their legislation would ensure that "quality, affordable health care is available for all New Yorkers." But it will have the opposite effect. One of the budget's more damaging provisions restricts the medicines doctors can prescribe by applying the "Preferred Drug List" — medications physicians are allowed to prescribe to Medicaid recipients — to the more than 500,000 New Yorkers enrolled in Family Health Plus, a state-run health care program for low-income families. The list consists mainly of older, cheaper alternatives to cutting-edge medicines. Considering that prescription drugs represent only 4.9 percent of the state's Medicaid budget, it's a penny-wise, pound-foolish proposition. This policy isn't anything new. Some drugs have always required over-the-phone approval by The results of this reform could be worse than anyone realizes. One survey by Project Patient Care and Harris Interactive found that in 2001 alone, drug restrictions caused 1.1 million Americans to experience negative health outcomes and 1.9 million to experience serious side effects because they couldn't get the meds they needed. The irony is that this cost-saving plan won't even work. Numerous studies have shown that instituting a rigid list of approved medicines doesn't save any money. This seems obvious — if a patient is denied the appropriate drug, he'll end up visiting the hospital and emergency room more often. The new budget also hits pharmaceutical companies for the right to treat poor patients. In order to get a drug approved and onto the Preferred Drug List, pharmaceutical companies have to pay a large "rebate" to the state. Drugs that aren't heavily discounted by the manufacturer are often left off the approved list. Fleecing drug companies in this way isn't only unfair, it threatens public health by siphoning money from research and development on tomorrow's cures. In the long run, this lowers the quality of health care for everybody, not just low-income New Yorkers. 0 Comments |