There’s a lot of talk about how our use of pharmaceuticals needs to be “more efficient.”

But what does “efficient” mean?

Does it mean more cost-effective or more medically efficient? Does it mean either?

Let’s call a spade a spade — “efficient” means short-term savings for payors (although, as we shall see in a moment, only in penny wise but pound foolish ways). Restrictive formularies (in the US both public and private) and health care systems (in the EU, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.

Perverse in so many ways — not the least of which is that “savings” are entirely transitory.

Consider the facts. A longitudinal prospective study by Dr. Susan Horn, et al.*, examined the relationship between HMO cost-containment strategies and utilization and total cost of health care for a number of medical (non-psychiatric) illnesses. The study showed that the tighter the formulary restrictions, the higher the overall cost of care — and what drove the increased costs was the association between formulary restrictions and utilization of care. (Many thanks to Dr. Frederick Goodwin — a CMPI board member — for calling this study to our attention.)

A blunter way of putting this is that “efficient,” as the term has come to be defined, has nothing to do with patient care. “Efficient” is a cost-based word and patient-centric concerns be damned.

Welcome to the world of health technology assessment, aka evidence-based medicine, aka rational use of medicine.

And remember, you can’t spell rational without r-a-t-i-o-n.

* If you would like to see the full study, here’s the full citation: Horn SD, Sharkey PD, Tracy DM, et al., Intended and unintended consequences of HMO cost-containment strategies: results from the Managed Care Outcomes Project. Am J Managed Care 1996;2:253-264

Jerry Avorn, the man who would be FDA commissioner in a Democrat administration, tried to show those of us lacking in the intelligence and Olympian insights that only a physician and researcher of his stature possess that permits him to teach at the Harvard School of Public Health based on the data dredging of grad students could understand why it is so important that we let him — and him alone - decide what medicines to take and when.

Jerry used a charming parable called “The Sting of Ignorance” to teach us what evidence based medicine really and truly is. Written in the NY Times it was a story of Jerry frolicking in the ocean blue when —jeepers creepers — a mean old jelly fish bit our Homeric health care hero on the calf (I know there’s a more scientific term for that muscle mass but I a taking a page from Jerry and keeping it simple) . Well no one— I mean no one— not even the wise and worldly author knew what to do to treat the pain. It took a nurse who JUST HAPPENED TO WALK BY to tell Jerry and all the First Aid trained lifeguards to stop applying alcohol and ice and make sure the jellyfish stinger was completely out.

Now as an aside, I am not Harvard trained and nor do I teach at Harvard. But I had a Bubbie. (You see I can be colloquial too. That’s SAT speak for folksy.) And when I was stung by a bee, before putting an ice pack on my arm where I was stung…my Bubbie made sure the entire stinger was out. I was about six then and it was something that every camp counselor knew whether it applied to yellowjackets or jellyfish.

But not in Jerry’s world. In Jerry’s world regular folks are morons and he lumps himself in their to prove a point (That’s a strawman folks.) In his NY Times article Jerry goes to the internet to do a google search to find out applying cold to a jelly fish stinger only helps spread the neurotoxin…he does that to make a point…wouldn’t it be wonderful if we could do a Google search on diseases to get a instant print out of what drugs to prescribe in each and every case.???

Yes indeed. One press of a button and you would get the right medicine for every illness in the same way that Jerry found the answer to how treat a jelly fish stinger when the rest of the boobs were screwing things up. And best of all, Jerry has been toling away to give the world the information they need to usher in this evidence based Uber Alles.

Except here’s the problem. Either Jerry is dishonest or those jellyfish neurotoxins have travelled to those neurotransmitters that control his memory….Jerry is really keen on warning old people not to take Vioxx because of the risk of heart attacks but he forgets his own research and that of others demonstrating that older people with rheumatoid arthritis are at higher risk for heart problems. He loves to talk about how restrictive formularies that shove generics down people’s throats increase compliance with drug regimens but ignores the mounting research demonstrating that such limits combvined with tiered copays discourage people from taking needed medicines. And in touting ALLHAT and claming that diuretics are more effective that calcium channel blockers, he ignores new research demonstrating that many sub groups live longer on newer agents and are less likely to have diabetes and kidney failure.

I could continue to point out the holes and exceptions and inaccuracies that, when woven together, make up Avorn’s ideologically-driven approach to evidence-based prescribing. But I couldn’t quite do it justice. It takes a degree of arrogance and condescension made possible only by repeated exposure to jellyfish neurotoxins.

http://www.nytimes.com/2006/09/16/opinion/16avorn.html

Knock. Knock.

Who’s there?

David Vitter.

David Vitter who?

David Vitter who doesn’t think that international drug counterfeiting is a problem.

Someone should put a hold on the junior senator from Louisiana — like a half nelson kind of hold.

I have repeatedly written that the Clinton-Murray hold on the von Eschenbach nomination would undermine the public health and FDA not because of the particular issue but because of the precedent of allowing a grandstanding senator to comingle politics with public healht by holding up the confirmation process. Well guess what? According to UPI:

“Fresh from giving the green light on Plan B in order to satisfy two Democrats holding up the nomination of Andrew von Eschenbach to head the FDA, two Republican Senators now say they have demands of their own that will have to be met prior to his elevation to the post. Senator David Vitter is demanding that the government provides a compromise agreement on importing drugs from Canada and Senator Jim DeMint is demanding that the abortion drug RU-486 is taken off the market, according to a report in The New York Times. Neither action is likely anytime soon and Vitter is predicting that Eschenbach’s nomination will remain in limbo until next year. Only yesterday, though, analysts were predicting clear sailing for his nomination in a vote scheduled for next week.”

Not this analyst. I had predicted that anyone who was intellectually feeble enough to strip law enforcement of the power to inspect pharmaceutical packages despite the fact it was an important part of the war against jihadists and organized crime (that’s Vitter) would hold the FDA commish nomination hostage until he got his way. The DeMint hold is the flip side of Plan B. I won’t get into the politics or the merits.. The DeMint stunt (why not just ban all forms of birth control while we are at it and roll back the availability of the HPV vaccine and medicines for STDs since they promote sexualy activitiy among minors?) .It is another step towards the political prostitution of the FDA. Will or does anyone have the guts to tell these granstanders to stand down? And when the will Senate put a limit on the use of holds for such destructive purposes?

I got a glimpse of what Medicare will be like after Mark McClellan leaves. There will be an emphasis on prevention, with a focus on using the drug benefit or rather tailoring it to the individual to keep people health and prevent chronic illness. Plans have responded to the desire to not only keep premiums low or avoid the coverage gap with new approaches. They are also developing — in cooperation with Medicare and thousands of volunteers and countless agencies — ways to coordinating the drug benefit so that it becomes a tool for preventing disease. McClellan and others discussed — at a My Health, My Medicare briefing at HHS — the importance of giving seniors the ability to obtain the best health value from the Medicare program. Ultimately, giving consumers control over health care dollars with the best clinical and cost information will make that possible. Medicare will drive this point home by making sure seniors get a checkup, flu and pneumoccal shots, colonoscopies and other preventive screens that are now part and parcel of the Medicare benefit. And all of this will be rolled out as seniors choose new plans during the month of October.

I can’t wait to see Democrats and the sourpusses at Families USSR try and scare seniors out of making these important decisions. Medicare has become a third rail of American politics again — but this time it’s because people feel a sense of ownership not entitlement as in the past. Watch when the D’s try to replace what Mark has helped create with a one size fits all price control system….

Yesterday the Washington Times ran an unsigned editorial pointing out that Move.org has a history of anti-semitism

Here is the editorial

MoveOn’s problem
TODAY’S EDITORIAL
September 13, 2006

In recent weeks, since drawing criticism for anti-Semitism on MoveOn.org’s Action Forum, the parent political organization has been finding a way to retreat without claiming responsibility for the thoughts and statements of its followers.
First, MoveOn.org decided to suspend the site’s operation until after the election to give the organization what it termed “a margin of safety.” When that looked too political, it restarted the site with a pledge to delay all postings by a day.
MoveOn’s political action director Eli Pariser insists that the organization knew nothing about the comments until they found out about them around Aug. 14.
Nice try. MoveOn itself notes it has full-time monitors who “spend the vast majority of their time looking for comments to pass on to the MoveOn team and doing weekly forum summaries.”
Mr. Pariser’s letter to the Anti-Defamation League claims MoveOn members “rose to sharply criticize the hate speech that was posted — even before it was brought to our attention.” But MoveOn monitors deleted criticisms from Bill Levinson of Israpundit.com well before it deleted anti-Semitic rants. Meanwhile, a post claiming “Jews control all the media” was made on Aug. 17, which is after MoveOn claims it “discovered” the problem.
Mr. Pariser tried to blame the comments “on a right-wing campaign to target the organization.”An Aug. 29 Op-Ed demonstrated that the forum’s anti-Semitism was just an extreme expression of what the most powerful radical-left political organization — one that gives money and support to Democrat candidates — really thinks and feels. Suggesting President Bush’s fight against terror is largely the result of excessive Jewish influence over Congress and the media is anti-Semitic. Asserting that Jewish policy-makers and Zionists in the Bush administration had a secret plan to invade Iraq and conquer the Middle East — a plan pushed by the all-powerful “Israel lobby” — is anti-Semitic.
MoveOn’s followers made that case time again, referring to “greedy Jewish pigs” and “Zionazis” in the process. And when a 2003 MoveOn position paper claims that Bush foreign policy advisers who supported the invasion of Iraq have “dual loyalties,” making policy decisions in the interests of Israel as much as the United States, it says the same thing with less colorful language.
Judging by its actions in the wake of this scandal and the tone of the paper, we can say with “a margin of safety” that MoveOn still has a Jewish problem. So do the candidates who fail to renounce the support MoveOn is giving them.

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 industryâs $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 Stanfordâs, 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 âa powerful inducement for physicians and patients to rely on medications that are expensive but not more effective.â

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:

http://www.cmpi.org

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…

http://www.nature.com/news/2006/060904/full/443012a.html

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:

http://www.fda.gov

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.

Arguably the most hardworking and innovative health care administrator in US history announced that he is leaving his position as administrator of the Center for Medicare and Medicaid Services. Mark McClellan has done more to change thinking and the culture of healthcare away from command and control, government run systems to a consumer driven approach that dovetails with the technological trend towards personalized medicine. Mark oversaw and helped engineer both transformations first as FDA commissioner through the Critical Path initiative and then as administrator of CMS with the implementation of MMA which apart from giving seniors drug coverage for the first time via Medicare has also caused millions of seniors to take charge of their health care dollars.

Mark’s tenure was not without controversy. He took on those who wanted to import unsafe drugs as a political stunt and threatened to demoralize and scare seniors into not signing up for the new benefit. But as Ronald Reagan said: “A leader, once convinced a particular course of action is the right one, must have the determination to stick with it and be undaunted when the going gets rough.”

That was the essence of McClellan as a health care policy leader.

On August 15 I had an op-ed in the Baltimore Sun on the growing dangers of counterfeit drugs (“Pharmaceutical Fakery is Health Care Terrorism”). I pointed out that one of the weakest links in the chain is the European practice of parallel trade.

I believed it then. I believe it now. Here’s a link to my original article:

http://www.cmpi.org

But I clearly ruffled some feathers Over There. Richard Freudenberg, the Secretary General of the British Association of European Pharmaceutical Distributors, dashed off a very defensive letter that appeared in The Sun on August 25.

(Here’s a link to the letter: http://www.baltimoresun.com/news/opinion/letters/bal-ed.le.25aaug25,0,2130712.story?coll=bal-oped-headlines.)

Among other things, he rants that my “allegations are, at best, unfounded, at worst blatently false.”

But not only does he think I am completely wrong, he proposes that he is completely right. He continues, “In fact, to date, there has not been a single case of counterfeit drugs in Europe which have entered the legitimate supply chain via parallel trade.”

To rebut Mr. Freudenberg, I asked Graham Satchwell, one of the world’s undisputed experts on counterfeit prescription medicines, to address the issue. Here is what Mr. Satchwell had to say — unexpurgated — and he pulls no punches.

RESPONSE BY GRAHAM SATCHWELL TO RICHARD FREUDENBERG:

Over two years ago I published a book on counterfeit medicines and organized crime. Since that time the matter has gained greater attention and one could reasonably believe that the Pharmaceutical Industry, the middle-men and the American public were becoming more aware — as indeed they must if they are to be adequately protected. It was heartening for instance to see the British regulatory authority, the FDA and World Health Organisation and others beef up there anti-counterfeiting efforts.

As part of the global campaign to raise awareness Mr. Peter Pitts wrote an article published in the Baltimore Sun on August 15 (“Pharmaceutical Fakery is Health Care Terrorism”).

So much to the good.

How disappointing then that the leader of the British Association of European Pharmaceutical Distributors has apparently had his head up his harness for the last two years.

In his response to the cautionary article by Peter Pitts, Richard Freudenburg commented, “Peter Pitts incorrectly links the worrisome issue of counterfeit medicines with the perfectly safe and legal practice of parallel distribution of medicines in Europe.”

Mr. F is of course wrong to glue the words perfectly safe to legal in the way he does, for they are certainly not inseparable. After all, prostitution, pot-holing, drunkenness, bungee jumping, and suicide are amongst the many types of behavior that are often legal but dangerous they also certainly are — similarly parallel trade in medicine — legal but not always safe.

Mr. F goes on to contend that, “parallel distributors source and sell products exclusively from EU countries and therefore do not facilitate the entry of products from non-EU countries such as Russia.” If only Mr. Fraudenberg could guarantee that that were always the case. However, if were to do so he would he would be naive, stupid or dishonest.

It seems to be a matter of overwhelming logic that in any given population you will have those who comply with the rules and who usually behave ethically and those who will break the rules because of perceived self interest or negligence. Were it not so then our planet would surely witness a race, tribe or occupation where crime and punishment were unknown.

Nevertheless, unprepared to leave his criticism there, Mr. F continues, and it seemed to me by this stage of reading Mr. F’s critique that he was developing a style, for he again links to distinct notions as if one, “Associating counterfeiting with Europe’s parallel distributors, who have operated successfully and safely for decades, is unjustified and irresponsible.”

“Successfully and safely?” The former means that they have made a lot of money, the latter is provably untrue for there have indeed been occasions on which counterfeit medicines have been found in the distribution chain and in the hands, or from the hands of those holding parallel traders licenses.

Perhaps Mr. F is unaware? Perhaps he shouldn’t be. Perhaps he should do a little research. Perhaps he would do a greater public service to the American public if he were to highlight the extreme weaknesses in the systems within Europe for the movement of pharmaceutical products and the dangers — real and potential — which that threat poses. But hang on, who does he represent? Well he is paid to represent the interests of those very European traders who benefit from parallel trade — strange coincidence you might think.

Mr. F’s slip is really showing when he offers the following, ‘In fact, to date there has not been a single case of counterfeit drugs in Europe which have entered the legitimate supply chain via parallel trade.” How very wrong you are Mr. F, please do some research.

Of course it might be that in Mr. F is only talking about the performance of his membership, which comprises, across Europe, only about 70 companies. Let me remind Mr.F. lest it slipped his memory, there are literally thousands of parallel traders licenses in existence in Europe.

The erstwhile Mr. F assures us “member companies across the EU, adherence to strict Good Distribution Practice guidelines is mandatory.” Yes Mr. F, like speeding restrictions on our roads, politicians declaring all their expenses properly, and little boys washing behind their ears.

Mr. F assures us all, “The idea that the EU’s latest enlargement round has compromised the safety of the European pharmaceutical supply chain also belies reality.” At this stage one might wonder about whose reality we are discussing here, Mr.F’s or the rest of the civilized world? For anyone with any doubt about the increased risk of all sorts of criminality which faces Western Europe from the newest members of the Union, please (a) do a Google search on such criteria as fraud+Eastern Europe, or (b) read what the EU officials or WHO or Interpol have said on the subject, or (c) read the rather detailed report of Dr. Jonathan Harper, or (d) simply ask any reasonably informed law officer.

There can be little doubt that few parallel traders would want to deal in counterfeit medicines, but as Mr. F knows, or should, it is the very act of removing original packaging with anti-counterfeiting features and repackaging those goods in translated items before shuffling them from country to country and dealer to dealer that affords the opportunity for the unscrupulous few to do real harm.

Two years ago I took the opportunity to publicly debate some of these issues, yet Mr. F. seems unaware of the evidence that so clearly undermines his position, surely he cannot have forgotten? If he has, then let me invite Mr. F to publicly debate these issues with me at any venue of his choice. This is a real and specific opportunity for Mr. F to set the record straight and once again here some hard facts.

Want to do it Mr.F?

There was a time when there were many voices in Europe and the USA echoing the sentiments of the bold Mr. F. Most have been embarrassed into silence, it is time for Mr. F to stop insulting the intelligence of consumers.

If any US reader wants to know more about the real situation in Europe then visit my website (PocoSolutions.com) go to articles and see the full text of A Sick Business and other articles.

Thank you, Graham. Well said.

Ringside seats for this debate between Mr. F and Mr. S (when scheduled) will be available at www.drugwonks.com.