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This from the NY Times
Stanford University Medical Center will prohibit its physicians from accepting even small gifts like pens and mugs from pharmaceutical sales representatives under a new policy intended to limit industry influence on patient care and doctor education.
….The move is part of a reaction against corporate influence on medicine at a time of growing concern over the safety and rising cost of drugs and medical devices. About 90 percent of the pharmaceutical industryÃ¢s $21 billion marketing budget is directed at physicians, according to an article by an influential group of doctors, scientists and lawyers in The Journal of the American Medical Association in January.
That article called upon academic medical centers to adopt policies like StanfordÃ¢s, saying that existing guidelines, like a prohibition of expensive gifts, did not go far enough. Some studies have shown that even small gifts create a sense of obligation, they wrote, while free drug samples are Ã¢a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective.Ã¢
If someone can explain the relationship between concerns about drug safety and corporate influence — in the form of pens and advertising — please let me know. Does passing out pens corrupt the prescribing process, thereby completing the circle of companies shoving unsafe medicines and ineffective new medicines through the FDA (because of the cozy relation of course) which in turn are marketed through ads that dupe and lavish buffets and junkets that seduce, thereby driving up drug costs which in turn are driving medical costs sky high?
Oh, I forgot the clnical trial data and medical journal articles that are skewed to drug benefit when in fact there is none.
Taken together — since this mantra has been repeated and amplified since the the 1950’s — or rather since this passion play has been produced and reproduced over and over and over again one can only assume that no new drug has any really benefit since they are more expensive than its predecessor and all have been marketed. And moreover, in the past they were marketed more extravagantly and with nicer parting gifts than some cheap pen or mug (I remember a medical student friend of mine getting clocks and briefcases) . So by the logic of the conspiracy theorists, no medicines really should work because they have all gone through this sick, money driven combine and indeed, it should have been worse in the past because the misbehavior was worse years ago.
None of which explains increase life expectancy, declinining mortalility, the fact that drug costs are still the smallest share of the health care dollar and smallest contributor to premium increases or that most of the validated scientific advances — elucidation of biological pathways based on genomics and proteomics — are coming from the pharma and bio industry.
In any event, what will the know it alls do when drug spending increases after all there so-called reforms are implanted in the minds of medical students because the drugs actually work in the clinical setting and their efforts to manage cost without caring for the wellbeing of patients fail.
The attack on drug spending is political, driven by technocrats and arrogant leftists like Jerry Avorn who care nothing about the impact their jihad has on long term health. They want to replace the clinical judgement of doctors with the one dimensional and politically driven decisions of politicians who are more interested in screwing drug companies than they are in saving lives or investing in changes that really save money down the line.
On September 11 of this year, the trial of Hamilton, Ontario pharmacist, Abadir Nasr began. He’s pleaded not guilty to a 12-count indictment alleging that he defrauded the public and pharmaceutical manufacturer Pfizer Products Inc. by the sale of “fake” and “grey market” drugs at his west Hamilton pharmacy.
Selling counterfeit prescription medicines is health care terrorism.
And terrorism is terrorism.
Here’s the rest of the story:
Hamilton Spectator File Photo
King West Pharmacy was where ‘fake’ Norvasc tablets were sold.
By Barbara Brown
The Hamilton Spectator
Beryl Preston was flying home to Canada from a winter holiday in Cuba when one side of her face went suddenly numb.
The retired Dofasco employee, who was taking six different medications for high blood pressure and other ailments, got the attention of a flight attendant, explaining the numbness was spreading across her face toward one eye.
The concerned stewardess offered an Aspirin, hot compress and a cup of tea and Preston, 61, gradually settled down and fell asleep.
Arriving home in Hamilton that February in 2005, she immediately made an appointment to see her doctor. The physician checked her blood pressure, which was high, and told Preston she had probably suffered a minor stroke.
All through the spring, Preston continued to feel tired and unwell. She saw her doctor weekly and underwent a battery of tests, but her blood pressure remained stubbornly high, despite her diet and medication regimen.
In mid-June of that year, the King West Pharmacy where Preston filled her prescriptions made national news when it was raided by the RCMP. Police seized a quantity of fake Norvasc, the same drug her doctor was prescribing to treat Preston’s high blood pressure.
Preston was told by her doctor to pick up a new prescription and have it filled at a different pharmacy.
Fifteen months later, Hamilton pharmacist, Abadir Nasr, 29, has pleaded not guilty to a 12-count indictment alleging that he defrauded the public and pharmaceutical manufacturer Pfizer Products Inc. by the sale of “fake” and “grey market” drugs at his west Hamilton pharmacy.
Assistant Crown attorney Cheryl Gzik asked Preston yesterday what her reaction was to being sold counterfeit and/or unauthorized medication.
“Well, I was dumbfounded. Shocked. Upset,” said Preston. “It was almost disbelief that it could happen.”
The Mounties turned up about 100 patients who were getting Norvasc prescriptions filled at the pharmacy. They began analysing the drugs that were in the cupboards of patients, but had no way of knowing whether any had been receiving fake or unauthorized drugs in the past.
Gzik told Ontario Court Justice Richard Jennis that about 44 patients had counterfeit Norvasc on hand. The drugs contained talc and no active medicinal ingredients.
Another 15 patients were given Norvasc manufactured by Pfizer, but specifically for Egyptian and Mexican markets and not authorized for sale in Canada. Two patients had Norvasc intended for the Turkish market.
Fifteen were dispensed authentic Norvasc properly authorized for the Canadian market, while others had a combination of fake, legitimate and unauthorized tablets.
The investigation began when a customer of the pharmacy noticed one round pill in her bottle of oblong, octagonal-shaped Norvasc tablets.
Frances Laforme had moved to Hagersville but was still driving to Hamilton to have her prescriptions filled. Laforme raised her concern about this odd round pill that was mixed in with her medication to another pharmacist who attended her church.
A few days later, she dropped in to see Michael Marini at the Dover Apothecary. Marini examined the round pill, as well as the rest of the octagonal tablets and compared them to the Pfizer Norvasc in his pharmacy.
He then Googled the code and description of the pills in Laforme’s medicine bottle. He learned from the Internet the pills were similar to Pfizer products then being manufactured for the Asian market.
Marini called Pfizer Canada’s lab in Montreal, which had him courier the samples for testing. Pfizer then sent two investigators to the Hamilton pharmacy with prescriptions to be filled. The drugs obtained by Pfizer’s undercover agents were analysed and as a result, the Mounties were called to investigate.
The pharmacy on King Street West has since been sold to owners who have no connection to the case and the stock has been replaced several times.
Jack Leon, 65, a vocation and bereavement counsellor, was appalled when the RCMP informed him that he had paid $203 for a bottle of talc pills.
Even before the news broke about the counterfeit drugs, Leon said he had noticed his Norvasc tablets — usually a brilliant white — had of late appeared “dusty” and flecked with grey.
Having not yet submitted a receipt to his drug plan, Leon called Nasr and demanded a refund. He said the pharmacist told him he could not return the money but would give him another refill.
“I didn’t go back,” said the twice-shy Leon. “Once bitten …” he added.
Two items of interest:
The first is the report of the U.S. Department of Justice’s Task Force on Intellectual Property. Must reading (and particularly so because they quote the CMPI report on the almost unobstructed growth of counterfeit prescription medicines).
The second is the latest report out of Europe on the same topic.
Both can be found at:
A follow up to the noxious fearmongering and the failure of the media to look at the implications of Congressman Markey, Waxman and the esteemed expert in clinical trial design Charles Grassley to scuttle non-inferiority studies and demand randomized clinical trials to determine safety and effectiveness for all medicines: There is no other way to say it than to state that such an approach would harm the sickest and most vulnerable among us and cripple efforts to accelerate treatments for Alzheimer’s, cancer and AIDS. Perhaps that it why even the NIH regards this politically motivated and doctrinaire approach to be unethical
Consider the following study:
“Enrolling children with asthma in the placebo arm of a clinical trial is common, harmful and ethically unjustified argue researchers from the University of Chicago and the National Institutes of Health (NIH) in the January 2004 issue of Pediatrics. After a systematic review of all clinical asthma trials involving children in the United States published between 1998 and 2001, the researchers found that children with asthma were more than twice as likely to be harmed — defined as forced to withdraw from the trial due to asthma exacerbation — if they did not receive standard asthma therapy compared to children who received standard treatment.”
Or here’s another way to look at it. If, as Markey (who has also pushed for a federal G force standard for rollercoasters) had his way, Ketek would be taken off the market. t’s “lethal” says he. Try telling that to the hundreds of thousands of children who would have died from community acquired pneumonia without it.
To my mind, the real killer in all this is not Ketek, but the politically motivated decisions of pols like Markey who ignore science and mislead the media for their own self serving agenda.
Thanks to the spreading outrage — unreported by the MSM — of the sanctioned anti-Jewish postings on the Moveon.org Actionforum (yes Osama, there was a moderator who saw and knew EVERYTHING) the blog itself has been shut down… Here is how the Moveon folks try to explain it away:
ActionForum Temporarily Offline
The MoveOn Great Goals ActionForum will be down until after the election. So much is happening with the MoveOn PAC Leave No Voter Behind campaign and other projects that our systems are at their limits. Suspending the Forum gives us a margin of safety and is a prudent thing to do. We will bring the forum back up after the election.
Well actually, Moveon changed course and is now imposing a 24 hour delay button its Forum monitors. So much for the margin of safety and prudence…
Wisely. Boldly. Timely.
Who Says What’s Best?
US News & Wold Report
By Bernadine Healy M.D.
Evidence-based medicine has the ring of scientific authority. But it’s not as self-evident as it sounds. EBM is a movement born in the 1990s as an alternative way of practicing medicine, in which “best” evidence, gleaned mostly from randomized clinical trials and cost-benefit studies, is the basis for what docs should or shouldn’t do. Touted as a way to improve patient care and restrain unnecessary treatment, EBM sees itself as a major shift away from traditional medicine that emphasizes the expertise of the medical profession. That includes knowledge of the underlying nature of disease, mechanisms of therapy, basic and clinical research, and physician experience. The autonomy and authority of the doctor, and the subsequent variability in care, are the problems that EBM wants to cure.
It’s no surprise that EBM draws strong support from governments that seek uniform standards to assess performance and cost effectiveness. According to Marc Rodwin, professor of law at Suffolk University Law School in Boston, EBM puts experts trained in social science, public health, epidemiology, and economic analysis on par with physicians and “breaks the lock hold” the profession has over how medicine is practiced and compensated. Depending on where you sit, that may be good or bad. But you still have to recognize that EBM carries its own ideological and political agenda separate from its clinical purpose.
Remember the mammogram wars over whether women should get them during their 40s? The protagonists were the EBM-ers who said no and the radiologists and oncologists who said yes. For the naysayers, randomized clinical trials were inadequate to show that the test saved lives, even though it did detect cancers sooner. Such a mammogram program would be costly, and unnecessary biopsies for false positive readings even costlier. But based on their interpretation of clinical evidence, cancer experts maintained that the test saved lives. What’s more, they factored in the nature of the disease: more aggressive in younger women and best cured if picked up early. But in 1997 the Department of Health and Human Services gave a thumbs down to recommending that women start having mammograms in their 40s. Women promptly exercised their political clout, which led to an HHS reversal. (In fact, the trend has been for more screening in this age group, not less.)
EBM also questions the prostate-specific antigen test, or PSA, for prostate cancer. The evidence-based method concludes that the test brings more harm than benefit, as it leads to unneeded biopsies and surgeries on often slow-growing cancers. This is at odds with the American Cancer Society, which says that men should have annual PSAs starting at age 50, and African-Americans, who have a higher prostate cancer rate, at age 45. This does not help that young primary-care doctor who published a mournful essay in the Journal of the American Medical Association in 2004. He did not get a PSA on his 53-year-old patient, based on his dutiful practice of evidence-based medicine. When found to have advanced prostate cancer, the patient sued and won. The jury put its faith in the medical experts who testified that PSAs are the best way to pick up tumors when they are most treatable.
Sift and sliver. Were these tests not so well known, the selective rules of evidence-based medicine might have prevailed. Patients would have been none the wiser. This concern underlies a scathing commentary on the EBM movement in the International Journal of Evidence-Based Healthcare by Dave Holmes, a professor of nursing at the University of Ottawa. He and his colleagues argue that EBM is “outrageously exclusionary” and even “microfascism” in the way it sifts knowledge. Though harsh, he makes a point: By anointing only a small sliver of research as best evidence and discarding or devaluing physician judgment and more than 90 percent of the medical literature, patients are forced into a one-size-fits-all straitjacket. Ironically, this comes at a time when both human genomics and informed patients are demanding more tailored and personal prescriptions for care.
EBM has its merits, but let’s make it just what it claims to be: a system to gather and synthesize evidence and disseminate it widely in order to enhance medical decision making. Do so using the full range of relevant medical knowledge and science and the foremost thinking of its experts, without political or ideological bias. This “best” EBM should be integrated into medicine, not be at odds with it.
The Froward Five of FDA Reform — U.S. Reps. Edward Markey (D-MA), John Dingell (D-MI), Henry Waxman (D-CA), Bart Stupak (D-MI) of the House Energy and Commerce Committee, and Senate Finance Committee Chairman Charles Grassley (R-IA) — desperately looking for a way to reinvigorate their FDA jihad, have requested that the Government Accountability Office (GAO) investigate the agency’s “reliance” on non-inferiority studies.
(FYI: Mr. Markey’s website refers to the FDA as the “Federal Drug Administration.” Glad he’s on top of these issues.)
Markey remarked, “The Bush Administration’s FDA has been working hand in glove with the drug industry for six years, leaving Americans vulnerable to dangerous drugs and insufficient information about the side effects of those drugs.”
Yes Virginia, before President Bush took office all drugs were 100% safe and label information was clearly commuicated
Also, last time I looked, the GAO wasn’t staffed with clinical trial design experts — they’re at the FDA.
(FYI — Mr. Markey — that’s the Food & Drug Administration.)
Remember the National Institute for Health Care Management (NIHCM) study? Remember NIHCM, the “nonprofit, nonpartisan organization dedicated to improving the effectiveness, efficiency, and quality of America’s health care system that just happened to be brainchild of one CEO of one major HMO who wanted to launch an attack on drug costs to get the press off his back onto the Rx industry? But never mind that. The study, written by one Mick Hunt said that the increase in drug spending between 1995 and 2000 was largely due to spending on medications that the FDA did not categorize as providing significantly improved efficacy or safety even as it ignored the number of new medicines receiving priority review increased and ignored vaccines and biologics. It also ignored research by Lichtenberg (which it was forced to include in a second version of a report) demonstrating that the consumption of the medicines the study derided actually reduced treatment costs and increased life expectancy.
Part of the goal of the study was to demonstrate how out of control drug costs were and are in terms of explaining huge increases in HMO premiums (at least at the Blues) A recent study by Americ’s Health Insurance Plans finds that non-drug medical costs accounted for 70 percent of average health premium increase in 2005.
Increased spending on physician services was the largest single contributor to the 8.8 percent average health premium increase in 2005. Outpatient hospital services such as diagnostic testing accounted for 22 percent of the increase followed by inpatient hospital services which accounted for 18 percent. Prescription drugs? The subject of the NICHM study and a Peter Jennings report based on the report and a slew of mainstrem media attacks? 16 percent? Other medical services were at 6 percent.
Why didn’t the media write stories about this fact? Why didn’t Ms. MickHunt include that in her dissembling and slanderous piece of propaganda? As Mark Twain noted, a lie can travel halfway round the world before the truth even gets its boots on….
Recently I wrote about a research paper in nature describing a procedure that supposedly produced stem cells without harming an embryo. Turns out that the paper had a lot of hot air and spin to it. It was written and published to appeal to those yearning to tip the balance in favor of embryonic stem cell research. But it claimed more than the procedure actually produced. In essence, the authors used science and shading of language to dupe us… Shame on them and on us for not reading more carefully…
What’s the trade-off between quality and speed? Can’t we have both? While this is a regular debate in the world of pharmaceutical development — it’s not so familiar in the realm of diagnostics. Until now — and it’s about time.
The issue at hand is FDA’s new draft guidance on a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients.
Here’s a link to the FDA announcement:
I also suggest, as recommended reading, an article in today’s edition of the New York Times by the always thoughtful Andrew Pollack. (Sorry — I am not able to provide a hot link, but the title is “F.D.A. Seeks to Regulate New Types of Diagnostic Tests.”)
Please note that this is a draft guidance — the agency is accepting comments. Now is the time to help the FDA design a final guidance that will allow for both speedier approval and higher quality.
It can be done. It must be done.