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Drugwonks
Latest News!Written By Comment Count Comment Last Three April 02, 2008
Dr. Robert Goldberg
Pharmalot blogs on the Consumer's Union report that one out of six people have had a bad enough reaction from a drug that they went to the hospital.
http://www.pharmalot.com/ Which raises the question: are people and doctors taking enough responsibility for how they take their medicines? Another question: are companies doing enough to treat consumers of medicines as customers, resolving problems, addressing side effects on an individualized basis instead of behind a battalion of lawyers.. My guess is the answer is no. Therefore simply dialing up the FDA to complain about one own's sloppy behavior is no way to resolve the issue. A better way would be to get patients with similar meds, conditions and characteristics to report and share information about their experience with all drugs, OTC, prescription, supplements within a virtual community. Then that information can be scrubbed and reviewed for trends and safety signals. Which is why CMPI is a proud sponsor of http://www.iguard.org the first patient created and patient centered source of information on how drugs are affecting people like you and me. The Consumers Union recommendation is well intentioned but old school. The way and wave of the future is http://www.iguard.org -
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April 02, 2008
Dr. Robert Goldberg
Peter Huber notes that new medicines replace what Lewis Thomas termed as half-way technology or palliative care and eliminates jobs and buildings along the way..
"Diagnosis used to be almost all doctor; now it's almost all lab--and the lab technicians rely on higher-caliber dipsticks, assays and reagents developed and mass-produced by the same teams of top-tier doctors, research hospitals and big drug companies. When drugs get good enough, they displace hours of ineffectual (but remunerative) human monitoring and palliative care. Drugs displace doctors, nurses and hospital beds because they really work and because they often work long before bad chemistry morphs into clots, plaques, lumps and other symptoms that require scalpels and beds. In the first half of the 20th century almost all medically supplied gains in health and life expectancy came from germ-killing vaccines and antibiotics. All the important gains since have come from arrays of drugs that target clogged arteries, strokes, cancer and other diseases rooted in our own human chemistry. Human eyes can't see and human hands can't handle most of the things that make us sick--bacteria, viruses, white blood cells, antibodies, proteins, enzymes, fats and genes." This is a variation of Lewis Thomas wrote over 30 years ago: "A multiplicity of new variants of antibiotics and chemotherapeutic agents has appeared on the market, but one would not expect that the rational use of this technology, even allowing for the high cost of development and marketing, would have proven to be anything like the previous cost of hospital care in the absence of such a technology..typhoid was a 12 to 16 week illness; meningitis often require several months of care through convalesence; these and other common infectious diseases can now be aborted promptly, within just a few days..." Thomas concludes: If our society wishes to be rid of the diseases, fatal and non-fatal, that plague us the most, there is really little prospect of doing so by mounting a still larger healthcare system at still greater cost for delivering essentially today's kid of technology on a larger scale....The harvest of new information from the biological revolution of the past quarter century is just now coming in, and we can probably begin to figure out the mechanisms of major diseases which were black mysteries a few years back as accurately and profitably as was done for the infectious diseases earlier in the century." In the 30 years or so since Thomas wrote that, his prediction has come to pass. We still have more to harvest however. And as Huber points out, to think we can do it without commercializing research reflects a hostility to capitalism and protectionism of the worst sort. Read Full Article -
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March 21, 2008
Dr. Robert Goldberg
For those in Soros/Essential Action camp who fervently believe the way to develop drugs for global health is to have the government coordinate and run trials with IP seized from private companies, the latest HIV vaccine failures underscore the ideologically riven fecklessness of their position.
The notion that prizes to investigators plus a pittance to those who develop and manufacture medicines under a government-run clinical trial operation will yield breakthroughs is naive: the risky part, the hard part, the part requiring hundreds of billions of dollars a year, is development. That is why commercialization is critical to medical progress, as are profits. The Soros/Essential Action model is based on hatred of capitalism not science. And in the end, it will doom the dying around the world to continued suffering. The groups will have their press clippings and accolades from the Left and those in need of breakthroughs will have nothing. Such is the perverted definition of "progress" advanced by George Soros and Essential Action -
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March 14, 2008
Dr. Robert Goldberg
Here's a link to a a video that shows how atherosclerosis happens. This arterial tour gives you a graphic view of how unhealthy habit and genes can conspire to clog the major routes that supply blood to the heart and back again. No butter with your popcorn when watching this movie. Steve Nissen makes a cameo appearance as an avenging LDL molecule..(Not really.)
Read Full Story -
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March 13, 2008
Dr. Robert Goldberg
The committee voted against restricting the use of ESAs to small cell lung cancer.
Question 2--Should FDA require that product labeling be modified? Please address each of four potential approaches to mitigating risks through revised labeling separately. a. To date, only clinical trials in small cell lung cancer have reasonably excluded an increased risk for death among patients receiving ESAs. Trials have demonstrated an increased risk of death and/or tumor promotion in head/neck, non-small cell lung cancer, breast (neoadjuvant and metastatic settings), lymphoid malignancies, and cervical cancers. Tumor types, other than those listed above, have not been adequately studied. Should the current indication be modified to restrict use only to patients with small cell lung cancer? Vote: YES-- 6 NO-- 8 Question 2--Should FDA require that product labeling be modified? Please address the following potential approaches to mitigating risks through revised labeling. b. Vote: The PREPARE trial demonstrated decreased relapse-free and overall survival in breast cancer patients receiving neoadjuvant chemotherapy. The risk/benefit assessment is different for patients receiving neoadjuvant and adjuvant chemotherapies than for patients with metastatic or incurable cancers. Should the current indication be modified to include a statement that ESA use is not indicated for patients receiving potentially curative treatments? Vote: YES--11 NO--2 The current indication should be modified to say that it should not be used in the adjuvant setting. c. Vote: Although increased tumor promotion and/or decreased survival have been demonstrated in several tumor types, adverse findings have been duplicated in two malignancies-breast cancer and head and neck cancer Should the current indication be modified to include a statement that ESA use is not indicated for patients with breast and/or head & neck cancers? (If yes, please specify breast and/or head & neck cancer). Vote: YES--9 NO--5 Modified to say that ESA use not indicated for metastatic breast and head and neck cancers. -
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March 09, 2008
Dr. Robert Goldberg
Leave it to the mainstream media to pump out the ultimate scare: Big Pharma pollutes the water supply!!!!
AP probe finds drugs in drinking water By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers "A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows." What no Viagra? What about OTC products? Is this some off-label use conspiracy? "To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe." Trillion? How about gazillion? "But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health." Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so. "And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife." Yes, truly alarming, especially when you claim we don't know the risks. "We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency." Yes and so does I.M. Krankee assistant administrator for administrators at the EPA. The evidence is overwhelming. The AP actually conducted a 5 month investigation. Most significant: "Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water." Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too? The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation: "We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany." Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together... Read Article Here -
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February 28, 2008
Dr. Robert Goldberg
While Peter was trying to calm the risk communication waters..here's my suggestion about embedding reporters: Don't.
There was some important research in JAMA about how 60 percent of adolescents don't respond to the first anti-depressants they receive but respond well to the second line of meds and cognitive behavioral therapy. That jives with earlier results of cross-over studies that demonstrate about 60 percent failure rate among depressed adults and their first SSRIs. Read More Of course that could explain why, in many studies, you get the zero effect vs placebo. That, and as Fred Goodwin has pointed out, the FDA refuses to allow crossover designs (adaptive trials of a sort) in neuropharm. And of course as genetic testing gets closer in antidepressants, as David Meltzer and others noted at a conference held by the ...that trial, error and miss approach to medication might be history. But you had to search mightily for that story yesterday in the media or the blogosphere. Instead, it was a sloppy meta-analysis (meta, as in sort of, analysis as in let the computer do it) of lots of placebo controlled trials of varying quality, design, exclusivity criteria that seemed to suggest what anyone who has taken an antidepressant knows is crap: they don't work. And of course while the media and the blogosphere sneer at the source research funding they are willfully blind to the incredibly poor study design of the meta-analysis in question as well as the limits of meta-analysis in general. Here's one of many hard sci bloggers piling on the silly stew of studies that was passed off as science. "Way too loose of p-values for false positives in studies, in medicine (and social sciences) compared to natural sciences, is one reason to not read too much into any individual study that claims antidepressants are ineffective, like the Public Library of Science meta-analysis of individual studies did. P-values of the same looseness as in medicine/social sciences have been used to claim intercessory prayer actually works on sick people (http://www.religioustolerance.org/medical6.htm), for example, or here (http://skepdic.com/refuge/bunk21.html) "I’m not saying that the results of a meta-analysis are no stronger than the weakest study in its umbrella. I am saying that, with p values as loose as they are in health/medicine (and social sciences), is that no massive amount of individual research studies being included under one meta-analysis will make the meta-analysis’ results anything more than a little bit stronger than the best individual study. In other words, in medicine, and in social sciences, meta-analysis adds a very modest bump, nothing more. The problem is, most people believe it does much more than that when it doesn’t. Or, to put it another way, meta-analysis is no better than the material it’s analyzing." Read More And here's another question: if they don't work, then why do they have such horrible but rare side effects? Is it really possible that drug companies just pumped drugs that were completely worthless except for the fact that they caused kids to commit suicide? But that's precisely the mindset of the media and to even more greater extent http://www.pharmalot.com and http://www.fiercepharma.com. Both sites totally ignored the JAMA study and focused on the meta-analysis. The JAMA study was a randomized controlled trial and the meta-analysis...well what can I say except what my high school English teach used to say regarding the difference between Cliff Notes and a novel: that meta-analysis is to real research what masturbation is to sex. Does anyone do any analysis of related analysis anymore or are journalist and bloggers just posting the facts that fit their pre-conceived notions. Does it tell you anything that the meta-analyses are easy to churn out and rush into print just before, say, the next FDA meeting of import? Such perspectives only encourage people not to take medicines or encourage them to stop taking them because they "don't work." It's irresponsible. Oh yeah... Here's the study that made antidepressants worthless.... Read More -
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February 19, 2008
Dr. Robert Goldberg
The Tufts Center for Drug Development -- enemy territory for drugwonks because of its concentration of RedSox rooters -- held a session on business models to improve R and D productivity recently...The takeaway point:
“No company – big, medium, or small pharma, or biotech – will develop new drugs entirely alone,” claimed the Center’s director, Kenneth Kaitin, at a recent panel meeting of industry executives in the US. “Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organisations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company’s core competence,” he added. Read More Meanwhile the Institute on Medicine as Profession, which is leading the purge of all contacts between industry and academia has a new program designed to cut the private sector out of drug development altogether. It is being lead by one of the leaders in drug discovery, David Rothman, PhD. ....Where would the government -- yes the government would be in charge -- get the money? What's in your wallet? Read More -
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February 15, 2008
Dr. Robert Goldberg
Here's Bart Stupak, head of the Health subcommittee on Energy Commerce, who is running the series of show trials on the FDA and the pharmaceutical industry (only anti-industry and FDA malcontents need testify) on the "link" between SSRIs and suicide:
"SSRI’s have not been proven effective in treating adolescent depression. To the contrary their use may actually increase the suicide rate of its young patients. In response to these reports of increased suicide rates with SSRI use, FDA officials suppressed their own post marketing surveillance, prohibited FDA employees from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRI remain on the market without a clear medical benefit to the patient." Setting aside the recent tragedy in Northern Illinois where the gunmen went off his meds, went on a shooting spree and killed himself. ...Stupak's statement is not only scientifically incorrect, it is downright misleading and dangerous. There should be a black box warning around everything Stupak says regarding medicines, particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides. And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general. Stupak held several fear-drenched hearing about antidepressants in 2003-2004. He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide. So the question is: And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn't he being held accountable? Here's Bart Stupak on the "link" between SSRI's and suicide -
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February 13, 2008
Dr. Robert Goldberg
Fiercemarket publishing adds another publication to its lineup today. Along with it's excellent coverage of the business and science of pharma and biotech it will now follow the money in FierceHealthcareFinance. The newsletter will cover managed care reimbursement policies,state and federal regulation, medical billing and coding and IT solutions for finance along with other issues.
Go to fiercehealthcarefinance.com for more information and subscription links. Best of luck! -
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February 08, 2008
Dr. Robert Goldberg
I find the hypocrisy on the Victoria Hampshire case amusing, predictable and disgusting. But it's just symptomatic of a larger trend fueled largely by hypocrisy.
Let's grant that Dr. Hampshire did find a serious problem with Pro-Heart and that Wyeth responded not by addressing the facts of the matter instead challenged Dr. Hampshire because she received $160 for prescribing a competitor's products through a website that gave her a cut of the drug sales. Once the supposed "conflict" was identified, all the alarms went off at the FDA. Senator Grassley and the media depicted this as some sort of intimidation of a whistleblower. How is Wyeth's behavior and the hell that Dr. Hampshire went through any different than when the roles reversed on any well meaning physician or researcher who follows the data but then is undercut by the COI canard? Is it only a COI when a drug company is involved? How about this...recently the Josiah Macy Foundation released a report demanding that industry funded CME must end and that any academic who receives industry funding should be barred from participating in CME events because of this COI stuff. Turns out that the report, was prepared as thecarlatblog.com notes by the brightest minds in medicine "The report was the product of a conference attended by many of the brightest minds in medicine", including Catherine DeAngelis, editor-in-chief of JAMA, David Blumenthal of Mass General and head of the Soros funded Institute on Medicine as a Profession which is leading the purge of academics who deign to work with industry; Harvey Fineberg, president of the Institute of Medicine, and David Leach, recent executive director of the Accreditation Council for Graduate Medical Education. Dan Duffy a senior adviser to the ABIM Foundation is a spin-off of the American Board of Internal Medicine, which profits from compulsory certification by internists and internal medicine subspecialists. As of 2005, the ABIM Foundation had over $60 million in its reserves, and its leadership has declared “professionalism,” as it defines it, as its mission.It was chaired by Suzanne Fletcher, emeritus primary care professor at Harvard Medical School The conference was held in lovely Bermuda not in downtown Baltimore. Next month, the IOM is holding a meeting on the issue of COI in CME as part of a study funded in part by...the Josiah Macy Foundation and the ABIM Foundation. Last year the IOM held a meeting, also paid for, in part, by Macy and ABIM. Here were some of the participants: Suzanne Fletcher Dan Duffy David Korn, VP for Research, AAMC and colleague of David A. Davis Eric Campbell, Phd who works under David Blumenthal at the Massachusetts General Hospital -- and is also associated with the Soros funded IMAP -- where he regularly compiles based on surveys what physicians have what financial connections with industry. These surveys are also paid for by IMAP. High profile medical journals publish the data. The New England Journal of Medicine appropriately prevents him from interpreting the results, but in response to press inquiries he clearly imparts that these relationships are dangerous and was quoted comparing company gifts to physicians to baseball umpires being wined and dined by team management. The JAMA let him conclude that “financial relationships are prevalent and therefore must be disclosed and managed.” Who is on the IOM Conflict of Interest Committee? Eric Campbell for one. Here is the sampling of the orientation of others on this supposedly objective panel: Bernard Lo, MD, Chair. He is an ethicist from UCSF who participated in the 1990s Clinton health plan. He has not published extensively on FCOI, although he published a survey of FCOI policies in The New England Journal of Medicine in 2000 (“Conflict of interest policies for investigators in clinical trials” volume 343, pp 1617-1620). In that publication he states: “We suggest that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research.” Robert P Kelch, MD, Executive VP, University of Michigan Health System whose last publication listed on Pub Med is entitled: “Maintaining the public trust in clinical research,” a summary in the New England Journal of Medicine in 2002 of the AAMC COI guidelines. Its conclusion states: “One cannot work simultaneously as an inventor-entrepreneur and a physician or other health care provider and maintain the trust of patients and the public.” And my favorite: George Lowenstein, PhD, Professor of psychology at Carnegie Mellon University and in the vanguard of the “social science research” that concludes physicians, contrary to their beliefs, do not know when they are being manipulated by sales techniques. At the AAMC symposium on “The scientific basis of influence and reciprocity” Loewenstein “stressed the following conclusions (pp. 23-24):” “Conflicts of interest will inevitably bias physician behavior, however honorable and well-intentioned specific physicians may be. Bias may distort their choices, or they may look for and unconsciously emphasize data that support their personal interests. The only viable remedy is to eliminate COIs whenever possible – e.g. eliminate gifts from pharmaceutical companies to physicians. This should include gifts of any size, because even small gifts can result in unconscious bias." So perhaps Dr. Hampshire was likewise suffering from unconscious bias or false consciousness. Or more generally, does that transcendent property only adhere to cash from drug firms and not trips to Bermuda from the same Foundation that is underwriting both the study designed to influence the IOM study and the IOM study itself? As I have written before, the issue of COI is largely a red herring. COI is all about the Left's discomfort with perceived corporate influence in medicine. The giveaway of course is this absurd idea that doctors don't know when a pen will corrupt them psychobabble that is the scaffolding of this purge. The compiling of gift and speaking registries, the movement to centralize all commercial support of research and education, conduiting it through central AHC administrations instead of to individual faculty members, ban all corporate samples and gifts to physicians and prohibit company sales representatives from visiting AHC faculty are all assaults on the free exchange of information and a threat to very canons of science. This assault on the free speech of academics -- which as I will show is nothing more than a thinly veiled and funded effort by trial attorneys to make it easier to sue doctors and overturn the FDA pre-emption doctrine with respect to what is on a drug label -- will not stand. The Academic Senate of the University of California System, recently rejected such proposals (“Proposed Guidelines Regarding Vendor Relations”), declaring them “vague, overbroad, addressing perceived rather than real concerns and in violation of academic freedom” (reported in Nature 448: 394, 2007). So to did the University of Medicine and Dentistry of NJ. This is just the beginning of a fight to take back medicine from the ideologues and tort lawyers. Ambrose Bierce defined hypocrisy as "prejudice with a halo." Exactly. Time to knock that halo off. -
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February 05, 2008
Dr. Robert Goldberg
Josh consulted extensively with biotech and drug firms. So apparently he would be barred by the likes of Daniel Carlat, Relman, Cassirer, Angell, Health Care Renewal bloggers and the Macy Foundation from any participation on FDA Adcomms or CME.
What is the difference between boycotting academics because of their affiliation with industry and boycotting academics because of their affiliation with Israel? Is this isn't a looming crisis of academic and intellectual freedom, it will be. -
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January 28, 2008
Dr. Robert Goldberg
Attacking the "conflicts" and "coverups" of companies and affiliated researchers in an attempt to discredit the commercialization of medical research comes at a price: undermining confidence in the science and the use of products themselves. As with all Ad Hominem attacks, particularly circumstancial, the fact that a researcher may stand to benefit from the acceptance of their research does not affect the validity of the research itself, since scientifically established evidence can stand or fall on its own merits. The failure to challenge such research in this fashion is of course, intellectually dishonest and manipulative. The consequence and object of such manipulation is to "frame" the choice or perspective of research as a risk to be avoid and as not relying on the research and its results as a place of certainty..
Which lead us to the spike in whooping cough cases triggered by the decline in the number of kids being immunized: "Before the development of a vaccine, whooping cough was a major public health threat, particularly from the 1920s to the '40s, when it infected as many as 265,000 Americans a year and killed as many as 9,000 a year, said Dr. Mary Healy, director of the Texas Children's cocoon-strategy program. Since the vaccine, she said, its annual incidence dropped to around 30,000 in the 1950s and as low as about 1,000 in 1976. It began creeping up in the 1980s and 1990s." Click Here for More Info Parents are convinced vaccines are unsafe not because of any evidence they are dangerous but because critics claim that the people pushing vaccines like Paul Offit are "conflicted" and therefore should not be trusted. ....Ditto the decline in SSRI and rising suicide rates because of "conflicts" and "coverups". This is now the new standard for determining whether or not research or a scientist is acceptable. Truth is now function of political correctness and adherence to the view that the commercialization of medical research is inherently corrupting. Can someone say Lysenko? Pseudoscience leads to pseudocertainty which leads to a decline in the public health. Those who claim that it "seems that negative studies are suppressed" are substituting emotion and bias for the scientific method. So too are those who change the subject from the outcomes to the studies to the character of those who sponsored them. Or as Saul Bellow once said: "A great deal of intelligence can be invested in ignorance when the need for illusion is deep." -
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January 25, 2008
Dr. Robert Goldberg
Just a matter of time before the juggernaut switched gears from Vioxx to Vytorin. (How cool that they go in alphabetical order, it will make life easier for the paralegals at least.)
Now we at drugwonks get to play our version of connect the dots as the purists line up on the side of the bottom feeders offering their services as consultants, their opinions in the media, white papers, policy support through web sites and groups like the Soros funded Prescription Project and the Institute on Medicine as Profession. We already have two"dots": Susan Wood, recipient of silicone breast implant settlement cash (where no evidence of wrongdoing or harm existed) Read More "Schering says there were problems with the way the data from the study were collected and analyzed, and that it needed all this time to fix those problems. Susan Wood, a professor at George Washington University and former Food & Drug Administration official, doesn't buy that. "You can't just say, 'Wait, we'll fix it,'" she says. "You have to get it out and let people decide." The other dot is Steve Nissen who of course has been conducting (for pay) his own set of studies to determine whether increase HDL (regardless of genetic variation) can lead to plaque reversal and can correlate with a reduction in death using his own imaging studies. According to Matt Herper he is gunning for Zetia. (Here's a link to an article where Nissen gushes over the plaque reversing power of a drug he was working on but has never, ever made it into human trials.) Read Full Article Here The lesson here: Don't you dare do a plaque reversal study with imaging as your surrogate endpoint without using Steve Nissen. Oh, another lesson: Steve Nissen does no work on genetic sensitivity to statins or personalized medicine, the real future. The ENHANCE study in its backhanded way essential demonstrated that Vytorin is the drug which can lower cholesterol for a small genetic subset but not reduce plaque. In any event, what people think about this matter -- and what to do about it -- will be shaped by their views of capitalism and medicine, not by the science. Will every large clinical trial of a drug on the market now become an opportunity to attack, expose, sue and investigate. I think so. The "dots" profit from it in terms of publicity, consulting fees, foundation grants, their cut from class action suits and consolidation of control over the conduct of clinical trials, prescribing patterns, etc. -
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January 25, 2008
Dr. Robert Goldberg
The New York Times "breaks" the story that the American Heart Association receives support from Schering and Merck. The implication is that the AHA came out with a statement as a result of that connection. Let's assume for argument's sake that this is correct. And let's forgive the AHA for putting Donny Osmond on their website.
Here is the gist of the AHA statement: Because Vytorin does not appear to be unsafe, lipid-lowering therapy with simvastatin is of proven benefit, and some patients have been prescribed Vytorin because a statin alone may not have been sufficiently effective in lowering their LDL or was not appropriate for them because of other medical conditions, we do not believe patients should stop taking the drug on their own,” said Dr. Jones. “However, patients on this combination drug should check with their doctor to see if they should stay on the drug, be switched to a statin alone, or take another combination of drugs for their cholesterol.” Does anyone have a problem with that statement. If I were a Schering or Merck handler I would not think I got my money worth. Or maybe the critics are not thinking conspiratorially enough. AHA also gets money from Novartis, GSK, Pfizer and other companies. Maybe they used their financial clout to water down what was going to be a hearty endorsement of the drug. Or maybe the money went to the millions AHA gives out in research grants to academic medical centers for CME and other reasons. Which is it? We don't know. And of course the rest of the pontificators have rushed to judgment based on the NY Times without regard to the essence of the AHA ENHANCE statement. The next point of course is that if the AHA is simply a paid for mouthpiece for Big Phama, it goals, views, tactics, etc by virtue of receipt of financial support, then that cause and effect relationship must apply equally to organizations and individuals who receive support from organizations. So therefore, physicians, researchers, etc who receive money from foundations such as Commonwealth, the Open Society Institute, Pew, Josiah Macy, etc to share its biases and ideology. Similarly, people from HMOs, insurance companies, CMS, Medicaid who share a cost cutting view will reflect that bias and particular view of technology. Finally, there is the so what question? As Ezekiel Emanuel as stated regarding for-profit IRBs: "What we should really focus on then is not the ideology of profit status but these substantive outcome data." No one has proven that the purist approach will produce better health, better drugs, safer medicines. The movement against so-called conflict of interest is all based on a revulsion towards the profit motive in health. It is more like the Taliban trying to purify the planet than a systematic effort to make medicine more patient centered based on an mechanistic undestanding of how to predict and prevent illness. The purists skip right past personalized medicine because it is not part of the grand scheme to rid medicine of the corruption. Quite the opposite, the evidence that expelling "commercial interests" from CME (I guess that would mean Danny Carlat and Howard Brody since they make money off books and lectures), academic detailing, state formularies based on so-called evidence based medicine, conflict free FDA advisory committees, the application of the precautionary principle to the development and use of medicine (don't use any new medicine for 7 years according to Public Citizen), turn over all drug development to government and shorten patents and of course a single payer system would improve health. Academic detailing according to CATIE and ALLHAT? One size fits all medicine? Paying doctors to prescribe generic when will have genetic tests and algorithms that indicate otherwise? The attempt to discredit researchers who have worked or have received funding from pharma is an intellectually dishonest and weak way to simply not engage in discussion or consider important, mechanistically valid research. It is the new Lysenkoism. You wouldn't know from all the rapid pharma hating that mortality and morbidity has been declining worldwide in direct proportion to the rate of introduction of new drugs, devices and surgical techniques. Medical technology has done more to advance and enhance humanity than anything else we could have come up with. Check that, the commercialization of medical technology. Rather, the piling on is just an expression of a hatred of capitalism. To paraphrase Aaron Wildavsky, my critics see medical technology as part of the apparatus by which corporate capitalism maintains inequalities that harm society and the public health. The piling on is a product of a particular view of how the world works. These are angry, fearful people who have a utopian plan to take medicine back to a pristine time that never existed. The disturbance is, in fact, in their psyche and souls. Their success in enacting their plan comes at the expense of the reputation of good scientists everywhere, trust in science generally and medical progress. To make themselves right, they would destroy others and rule over the rest. -
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January 23, 2008
Dr. Robert Goldberg
Jan 22, 2008 20:58 | Updated Jan 23, 2008 9:48
Oxford Union stages 'farcical' debate By JONNY PAUL, LONDON From the Jerusalem Post Oxford University's debating society is being accused of childishness and sensationalism by Jewish groups after inviting participants with alleged anti-Israel backgrounds to support a motion questioning Israel's right to exist in a debate on Thursday.... Proposing the motion are Norman Finkelstein, formally of De Paul University in Chicago, and Ted Honderich, professor of philosophy at University College London. Finkelstein's books include The Holocaust Industry: Reflections on the Exploitation of Jewish Suffering and Image and Reality of the Israel-Palestine Conflict. On his Web site, he hosts Brazilian cartoonist Latuff, whose work won second prize in Iran President Mahmoud Ahmadinejad's Holocaust denial art competition in December 2006.... Opposing the motion in the Oxford debate is Palestinian scholar and activist Ghada Karmi, who believes that Jews do not constitute a nation and they lack "biological, racial or national characteristics." Joining Karmi is Israeli academic Ilan Pappe, currently at Exeter University in the UK. Last February, Pappe declared his warm friendship with Hamas leader Ismail Haniyeh and suggested that Hizbullah leader Hassan Nasrallah "should be put on the committee to decide the future of Israel." Emily Partington, president of Oxford University Union told The Jerusalem Post: "The motion was decided upon as it is a current topic of discussion, and people who might not have extensive knowledge about the State of Israel may well question the existence of a state which appears to differ so greatly from others. Much of the interest in the motion derives from the debate about what constitutes Israel, and what Israel does. All of the participants in the debate will be arguing from their own independent perspectives, rather than representing anything or anyone else." Translation: we excluded people who support Israel from the debate who are "paid" to represent Israel and who therefore are obviously biased in their view of a what a state is and should be is so different (and by our standards, racist.) So our debate is really the fair and balanced one because our participants independently concluded Israel should be wiped off the map. Excluding scholars because they associate with Israel or disqualifying them because they represent Israel is just plain wrong. The same goes from barring them from engaging in important research, holding faculty positions, sitting on panels, etc? Where does the the game of connect the dots turn into outright persecution? Isn't it wrong in other areas of intellectual and political life as well? Read More -
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January 21, 2008
Dr. Robert Goldberg
Let me respond to the latest tut-tut from Roy Poses who insist he isn’t calling physicians who work for drug companies or consult for them prostitutes but just wants transparency about their funding sources. I see a backtracking big time, much hypocrisy and huge bias. There is no doubt Poses is part of the “I hate Pharma” crowd along with many in the blogosphere. And he presumes that the only source of bias that affects the public health adversely – mostly without empirical evidence – is financial inducements from drug companies. He even uses the pejorative term “collaboration” as in drug companies are “now are the largest collective source of medical research money, they are thus under great pressure to collaborate with these companies. An academic trying to raise research money from one such company might find it hard to resist offers of consulting fees, speaker’s honoraria, advisory board positions, etc from that company. But once the academic thus starts to work part time for the company, who knows where his or her interests lie?”
So for Poses the mere receipt for pharmaceutical research dollars is like alchemy, transforming the pure, virginal scientist into someone who – along with his or her results – can be twisted into something that reflects the desire for profits, not the public health. By his standards Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses just got one Merck grant back in 1997-1999 (which he never declared on his blog). He gives two examples “For the final words, let me quote Dr Stefan Kertesz, who was commenting on the pervasiveness of conflicts of interest affecting the 2004 National Cholesterol Education Panel guidelines that suggested drastic lowering of cholesterol for patients with heart disease and diabetes. (Hat tip for this to DB's Medical Rants.) These controversial guidelines may be one reason physicians feel compelled to use drugs to lower cholesterol which have, like ezetimibe, no proven independent benefits for their patients.” Controversial? Most of the people who Poses and Kertesz slime by association did the original work to establish the value of statins in the 1980’s. Does Poses not prescribe statins to people with high LDL and low HDL. And for him to say he won’t prescribe Vytorin because it has not proven independent benefit is shocking. It is both wrong and demonstrates he practices political science, a science driven by his guilt by association mentality. Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to “natural” cholesterol lowering products that they sell, etc. No conflict there? Is it ok for physicians to promote and consult for companies pushing this approach? Let us go further. So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind or biased eye towards other sources of conflict. Indeed, he ignores his own position stated in another post: “I think Anaissie et al have demonstrated the glaring need for tough regulations requiring disclosure of all financial (and probably political) conflicts of interest affecting anyone who can make decisions, for individuals or organizations, in health care. Basically similar regulations should apply not only to government agencies and academic medical institutions, but also all other health care organizations, not-for-profit and for-profit included.” Indeed, by focusing exclusively on financial conflicts and indeed only one subset of such monetary influences – ignoring funding from foundations, government business grants such as SBIR funds, money from consulting for trial attorneys or tort settlements, -- Poses and others ignore other forms of biases that can be as or more dangerous. As John P. A. Ioannidis wrote in Why Most Published Research Findings Are False: “Conflicts of interest and prejudice may increase bias, u. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Prejudice may not necessarily have financial roots. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings. Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations. Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable]. But let us focus on other forms of bias. For instance, the Prescription Project, which according to it’s website seek to ensure that “ industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information is essential to promoting sound and cost effective health care.” The Prescription Project has advisory committee members that consult for or work for the largest HMOs and the generic lobbying group. It obtains substantial funding from George Soros, as do many other organizations intertwined with The Prescription Project. The PP also “collaborates” with the Community Catalyst Group, another leftist organization that receives support from the Prescription Access Litigation Project. So the Prescription Project benefits indirectly from an organization that receives funding from trial lawyers. Should Poses be suspicious about the choice of drugs made by The Prescription Project based on their source of funding? Not a peep. In the end, Poses may be right to be cautious but the caution should be comprehensive or it is simply part of an ideological push or grab for power. The point is, conflicts are a problem but ideological agendas and professional hubris can be deadly or truly damaging. I have not even touched the human cost of Steve Nissen’s attack on ADHD medicines, Avandia, etc. or the hype surrounding vaccines or SSRIs. I will only quote Marcia Angell who noted: “Modern history is replete with instances of fervent beliefs or conventional wisdom being proved wrong by scientific research. Only a commitment to evidence can test the hopes, fears and biases that otherwise would have full sway. Science is sometimes messy and slow, but it’s the only method we have to answer questions about the material world and to evaluate the many health scares that recurrently sweep across the country. Like democracy, it’s better than whatever is second best, and we ignore it at our peril.” -
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January 16, 2008
Dr. Robert Goldberg
A non-addictive drug for chronic pain? A breakthrough that sounds too good to be true. And to make matters worse, it's an "just" an "incremental improvement on an existing medication." And horrors of horrors, the brains behind this Clifford Woolf -- one of the world's experts on the molecular pathways of pain -- has been (sorry to say) a consultant to several drug companies.
So obviously nothing he develops can be trusted. Particularly if it relies on techniques developed through partnerships created to promote the Critical Path via the Reagan Udall Foundation. A poisoned source will only produce poison. Especially if the funding is from Big Pharma at any point in time it's forever tainted and untrustworthy. Everything else said and done and funded from all other sources can be relied on without a doubt. So the rule of thumb(s) should be. Let us call them the Poses Postulates in honor of Roy Poses MD of the Health Care Renewal bog who believes that anyone who receives any funding from Pharma cannot be trusted. Don't trust Pharma research or the researchers they pay. Don't trust the drugs they produce or market since the FDA is nothing but a tool or client of Pharma. Don't use any drugs, especially those developed since PDUFA was enacted since that institutionalized the incest. So if and when these new pain drugs come out...those who abide by this ideological approach to prescribing should avoid these treatments out of precaution and principle. Read More Right Dr. Poses? Pharmb366
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January 15, 2008
Dr. Robert Goldberg
Here are two of the qualities Leon Wieseltier in The New Republic like about about John McCain that make him a nearly ideal presidential candidate. "anxiety over the environment and contempt for pharmaceutical companies."
Contempt for pharmaceutical companies? And how does that translate into good public policy? Pushing for drug reimportation? Patent seizures? I think there is a bit of projection on Leon's part but what prompts this hatred? What did drug company's do wrong that deserves contempt? I know this will tick off the whack jobs that equate anything that is sponsored by drug companies as a pollutant or a criminal activity, but I really would like to know. kookimebux
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January 01, 2008
Dr. Robert Goldberg
"VANCOUVER, Wash. -- A McDonald's employee in Vancouver is a new mom after a fast delivery at the fast-food restaurant.
Danielle Miller, 16, was working at the McDonald's on Gher Road and state Route 500 on Dec. 21 when she suddenly felt ill and ran to the bathroom, reported television station KPTV in Portland, Ore. A friend and co-worker of Miller's followed her into the restroom and asked her if she was pregnant. Miller said no. But moments later, with the assistance of a 911 dispatcher, the friend helped Miller deliver her baby in the McDonald's restroom." Gives a new meaning to "Do you want fries with that?" http://www.wesh.com/family/14953330/detail.html -
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