Big Pharma's Dirty Little Secret

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http://www.cancer-coverup.com/newsletter/03-2004/Big Pharma's Dirty Little SecretMonthly Newsletter |

www.cancer-coverup.com |March 2004BY KATHLEEN B. DEOULA stunning admission from a senior official of the pharmaceutical giantGlaxoSmithKline has vindicated critics of the drug industry. At a Londonconference last December, Dr. Allen Roses, a senior vice president ofGlaxoSmithKline candidly admitted that most prescription drugs work only part ofthe time, and in many instances less than HALF of the time!Dr. Roses, one of the world's leading geneticists did not intend his comments asa criticism of existing prescription drugs. Rather, he was arguing for somethingcalled "pharmacogenomics," the use of human genetics to create "tailored" drugsfor patients with different genes. This method, he believes would result in moreeffective pharmaceuticals and elimination of what he calls the "trial and error"method of prescribing drugs currently

employed by most physicians.While his vision of a future in which drugs are custom-designed for particularpatients or groups of patients may be intriguing, the notion of physicianswriting prescriptions by guess and by gosh is chilling.And how bad is the problem?DRUGS DON'T WORKAccording to Dr. Roses, the problem is much worse than anyone might haveimagined.He told the audience that fully 90% of prescription drugs only work 30% to 50%of the time!More important, some of the least effective drugs are the ones whose failure tobe effective would have the most serious consequences.For example drugs to treat Alzheimer's disease work 30% of the time or less!Cancer drugs are at best effective 25% of the time, and in some instances, theeffectiveness can be as little as 2%!Drugs intended to treat hepatitis C are effective less than half the time.Even drugs for more common and less life-threatening

conditions have poor trackrecords.For instance, drugs to treat migraines are at best a 50/50 proposition.Similarly, incontinence pharmaceuticals only work about 40% of the time.Even widely used and expensive COX-2 pain relievers like Vioxx and Celebrex arefar less effective than the public would be lead to believe.What is perhaps most shocking about Dr. Roses' admission is that it came as nosurprise to other drug industry executives. One industry expert asked to commenton Dr. Roses' claim said "Roses is a smart guy and what he is saying willsurprise the public, but not his colleagues."As it turns out, the fact that drugs do not work is one of Big Pharma's bestkept dirty little secrets.But, what about doctors? Don't they know whether or not the drugs they areprescribing are effective?The short answer is no.In this era of managed care and 7 minute time limits on patient visits, fewdoctors

take the time to really research the drugs they prescribe. Instead, theyrely on the handouts dutifully delivered by the "detail" men and women - thefancy name for salespersons used by Big Pharma - to assess the efficacy of newprescription items.CONSUMER ADS A CONSUMER CONBut that's not all.So-called "direct to consumer" advertising encourages patients to requestspecific drugs, and more often than not, doctors go along with those requests.For example incontinence drugs are widely promoted in television ads that implythat they can provide miraculous improvement in this condition. What the ads donot say is that the drugs, to the extent that they work at all, are effectiveless than HALF THE TIME! More important, they don't mention that the drugs havepotentially serious side effects. Given the significant quality of lifeconsequences of incontinence, it is no surprise that the ads have caused a sharpincrease in patients

requesting such products or that doctors have given in totheir patients and prescribed them.But these drugs still represent an improvement in efficacy - right?Wrong!THE OTHER DIRTY LITTLE SECRETTwo recent studies have exposed another of Big Pharma's dirty little secrets:many of the new and expensive drugs they're pushing on patients and doctors arenot as effective as the ones they're intended to replace!Researchers in St. Louis examined claims data from a major Midwestern healthprovider to see if the actual results of using expensive pain relievers likeVioxx and Celebrex matched the assumed efficacy of the studies used todemonstrate their value.The results of their analysis were reported in the November, 2003 issue of theJournal of Managed Care.One of the things they examined most closely was the rate at which patientstaking COX-2 inhibitors were also using drugs to prevent heartburn or

ulcers.According to the research presented to win approval of these drugs, patientstaking them shouldn't have to take the anti-ulcer and heartburn medications.Well, as it turns out, like much drug company research, the claim was a lot ofhooey!Patients given the newer COX-2 drugs were also given prescriptions foranti-ulcer and heartburn medicines. The real stunner, though, was that thepatients taking the newer drugs were actually prescribed the anti-ulcer andheartburn drugs MORE often than those on the older pain relievers - 20% for thenew drugs vs. 18% for the old!Now, understand what's happening here. A bottle containing 50 capsules of aCOX-2 inhibitor like Vioxx or Celebrex is going to set you back around $180.00.In contrast, you can buy a bottle of 200 generic ibuprofen tablets for around$13.00, 500 acetaminophen (Tylenol) tablets for around $12.00 or 500 genericaspirin tablets for around $7.00!The whole

rationale for taking the more expensive drug is that you wouldn't haveto take a second drug to protect against ulcer or heartburn with the newermedication. Otherwise why would you pay the extra $160.00? As it turns out,that's not true, so all the hype about COX-2 inhibitors is little more than away for Big Pharma to fatten its profits at the consumer's expense - once again!Still, the phony assumptions about COX-2 inhibitors only tell half of the story.The other half comes from another study published in the Journal of Managed CarePharmacy.THE REST OF THE STORYIn a September, 2003 article, researcher Brenda K. Motheral, Ph.D. examined thecost-effectiveness of ulcer treatments.Currently, most physicians prescribe expensive drugs like Prilosec or Nexium,the so-called Proton Pump Inhibitors or PPI's as the first line of attack. Ifthat should fail, most often they recommend surgery. The only problem is thatthe

assumption underlying the PPI treatment - that ulcers are caused by excessstomach acid, aspirin, or stress - is wrong! Researchers have discovered that in90% of the cases, they are caused by a bacterial infection that can be easilytreated with a combination of cheap antibiotics and bismuth subsalicylate e.g.Pepto-Bismol!According to Dr. Motheral, the bismuth-based therapy is both cheaper and moreeffective than using PPI's. This is no small consideration. Ulcer medicationsare among the most widely prescribed, and are costly. A typical prescription fora PPI runs between $150 and $200 per month, and patients generally have to takethem for their entire lives. This can come to hundreds of thousands of dollarsover time - indeed PPI's account for fully 8.9% of total drug costs and a hugeproportion of drug company profits. But they represent something else as well:hundreds of thousands of dollars per patient that are not available for

othermedical care.And keep in mind - even when an ulcer is surgically removed, if the cause is abacteria, it will come back! So the risk and expense of the surgery would havebeen for nothing.Dr. Motheral put it in perspective "Given that patients pay portions of premiumsand copays, promoting cost-effective treatment decisions ultimately controls notonly payers costs buy also patients' out-of-pocket expenditures."It's not just the St. Louis researchers, however, who are blowing the lid offBig Pharma's efficacy scam. Take for example high blood pressure drugs.Last year, Big Pharma got a windfall when the National Institutes of Healthmoved the goalposts on high blood pressure. It used to be that blood pressure of130/85 was considered normal. But late in 2002, the Institute of Medicinedecided that was no longer the case and created a new category"prehypertensive," for people with blood pressures between 120/80 and

139/89.All of a sudden Big Pharma got tens of millions of customers for its expensivehigh blood pressure drugs!What they didn't know was that at that very moment, someone was about to pullthe rug out from under them.A December 2002 article in the Journal of the American Medical Association(JAMA) reported the findings of a study encompassing over 42,000 individualscomparing the benefits of four types of high blood pressure drugs - diuretics,ACE inhibitors, calcium channel blockers and alpha-adrenergic blockers. The newswas, to say the least, unwelcome in Big Pharma's corporate offices.What the researchers discovered was that cheap, generic diuretic drugs that havebeen around for years were far superior to the new and expensive high bloodpressure medication Big Pharma has been touting.The individual results were stunning. In the case of ACE inhibitors, thepatients averaged 2 points higher on systolic pressure and

had a 15% higher riskof stroke. For African-American participants, the risk of stroke was 40% higher!For calcium channel blockers systolic blood pressure was only about 1% higherbut they had a 38% greater risk of developing heart failure. The portion of thestudy using the alpha-adrenergic blocker was actually stopped because peopletaking the drugs had a 25% higher rate of heart disease than those on diureticsand were suffering double the rate of heart failure!Given these facts, it would make sense for the medical community to pushdiuretics, but that doesn't seem to be happening. There's too much money atstake for Big Pharma to give up their hypertensive drug cash cows.For example Pfizer's Norvasc, which sells for around $172 for a month's supplywas projected to earn the company $4 billion in 2003, and that's just oneexample. Like Norvasc, most of these drugs, regardless of class, cost around$175 for a month's supply. With

tens of millions of new potential customers, BigPharma is not about to give up its market without a fight.One of their latest tactics is to simply stop manufacturing diuretics.Doctors in Norway recently protested Merck & Co.'s decision to stop makingDichlotride, the only pure form of hydrochlorotiazide (the most commonly usedthiazide) available. There is no generic alternative available on the market.Although Norway's situation is unusual in having no generic alternative, it isnot apparently unique, as several other European countries have reporteddifficulty in obtaining the thiazide diuretics as well.Although the problem has not yet spread to the United States, can there by anydoubt that what Big Pharma is really doing in Europe is testing whether it canget away with suppressing a cheaper alternative to its expensive and ineffectiveanti-hypertensives? Can there be any doubt that they will do the same thing hereif

they believe they can get away with it?Not if you know Big Pharma!REGULATORS FAIL TO ACTWhere, you might ask is the government? After all, how can Big Pharma advertisethese drugs as being effective when they are not? Doesn't the governmentregulate pharmaceutical advertisements? Won't it make sure that they aretruthful?The answers to those questions are yes, and no.Yes, the government is supposed to regulate pharmaceutical company ads.Specifically, they are supposed to look out for ads that are misleading. WithBig Pharma spending over $2.8 billion on direct to consumer ads, this certainlyis an important task. The trouble is that the FDA is falling down on the job.Since direct to consumer ads were first allowed in 1999, the proportion of FDAcitations per complaint regarding drug advertisers has steadily dropped. In themost recent year for which complete data are available, the FDA cited onecompany for each

eight complaints it received. The year before, however, it hadcited one company for each seven complaints.What is more important, though, is that it took on average six months from thetime an ad campaign was initiated until some action was taken. This meant that amisleading ad could run for HALF A YEAR before anything was done about it. Eventhen the most likely action would be to ask the drug company to stop running thead.And that's just the average!It took the FDA a full year to tell the giant Aventis pharmaceutical company tostop running misleading ads about its drug Taxotere.But even when warning letters go out, they're hardly more than a slap on thewrist.FDA Commissioner Mark McClellan has promised to make enforcement measurestougher, but only time will tell if he means what he says.The good news is that the FDA Commissioner seems sincere in his promise, and nowwith studies such as those done in

St. Louis and for JAMA, there is a growingbody of evidence on which to base regulatory decisions. Still, it remains to beseen whether real change will take place, or whether Big Pharma will be able touse its influence to squash critics. Until the future is clear, consumers willhave to rely on the old adage that holds "If it sounds too good to be true, itprobably is."

 

 

 

 

karl theis jr

http://groups.msn.com/exposureofthetruth

 

 

 

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