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WELCOME TO EAST ST. LOUIS,Ill., population 26,700 — and routinely cit-ed year after year as the most dangerous

city in the United States.Here, in a federal courtroom about a mile up the

road from the mighty Mississippi River, the reputa-tions of three of Hamilton’s most vaunted medical in-stitutions and a few of their most prized researcherswill soon be put to a serious test.

The court in East St. Louis has been chosen as theAmerican battleground for a potentially bruising skir-mish over the safety of a drug intimately connectedwith some of Hamilton’s top cardiovascularresearchers.

The drug, known as dabigatran and sold commer-cially as Pradaxa, is an anticoagulant hailed by someheart specialists as a dream come true — a safe, easy-to-take alternative to warfarin.

Warfarin is the long-standing but tricky treatmentof choice for over half a century for patients at risk ofstroke because of a common type of heart arrhythmia.

On one side are nearly 2,300 plaintiffs — or their es-tates, in the case of some dead patients — from acrossthe U.S. who believe they were harmed by Pradaxa, adrug they say should now be considered unsafe.

On the other side is Germany-based pharmaceuticalgiant Boehringer Ingelheim, developer of Pradaxa —originally known as Pradax — which has reachedblockbuster status in three short years, with annualsales of the drug now topping $1 billion.

Dragged into the fight alongside Boehringer Ingel-heim as co-defendants in some of the cases are McMas-ter University, Hamilton Health Sciences and theirjointly operated Population Health Research Institute.

The institute ran the one and only clinical trial forPradaxa, called the RE-LY trial, that resulted in thedrug’s approval in Canada and the U.S.

None of the allegations that have been made againstBoehringer Ingelheim or the three Hamilton organiza-tions have been proven in court.

In the middle is a judge appointed 16 years ago bythen-U.S. president Bill Clinton who has already hand-ed out nearly $1 million in fines against BoehringerIngelheim because of its objectionable behaviour.

SPECIAL REPORT

Trial and errors?In an unprecedented case, McMasterUniversity and Hamilton HealthSciences are facing lawsuits in the UnitedStates over the safety of the drugPradaxa. As The Spectator’s Steve Buistreports, the lawsuits allege thatregulatory approval for the popularanticoagulant was partly based ontainted data from clinical trials led byHamilton researchers.

Pradaxa continues // A10

“HamiltonHealth Scienceshas everyconfidence inthe conduct andintegrity of theresearch of thePopulationHealthResearchInstitute.”STATEMENT RELEASEDBY HHS

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A10 SATURDAY, FEBRUARY 15, 2014 THE HAMILTON SPECTATOR l THE SPEC.COM

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And that’s even before the firstcase has gone to trial.

Boehringer Ingelheim and itsGerman parent are facing allega-tions that include gross negli-gence, misrepresentation, designdefects with the product, failure towarn patients, fraud and fraudu-lent concealment.

The allegations against McMas-ter, HHS and the PopulationHealth Research Institute (PHRI)are just as serious — negligence,negligent misrepresentation,fraud and fraudulentconcealment.

What’s more noteworthy, how-ever, are some of the very seriousspecific allegations that have beenmade in the lawsuits against thethree Hamilton organizations.

The lawsuits allege that Mc-Master, HHS and PHRI:n Failed to adequately designand administer the Pradaxa clini-cal trial.n Failed to properly maintain da-ta related to the clinical trial.n Failed to report serious ad-verse events related to Pradaxa inan effort to gain favour withBoehringer Ingelheim by assist-ing in the process of getting thecompany’s drug approved by theU.S. Food and DrugAdministration.

HHS, McMaster and PHRIwere “under a duty to disclose tothe plaintiffs and the plaintiffs’physicians, hospitals, health careproviders and/or the FDA the de-fective nature of Pradaxa, includ-ing but not limited to the height-ened risks of excessive and/or un-controllable bleeding,” the law-suits allege.

“This is a safety issue, it’s a pub-lic health issue,” Roger Denton,the lead lawyer for the Pradaxaplaintiffs, said in an exclusive in-terview with The Spectator.

“What goes on in these clinicaltrials in this litigation ought to beout in the public,” added Denton,who is based in St. Louis, Mo.

The allegations contained in thelawsuits, if proven true, could be adamaging blow to the reputationof the Population Health ResearchInstitute, which organizes andruns clinical trials in Canada andlocations around the world.

The amount of money at stakein the Pradaxa lawsuits has notbeen established. In Americancourt practice, awards and dam-ages in civil cases are determinedby juries.

THE INVOLVEMENT ofthree Canadian public institu-tions as defendants in an Ameri-can legal battle over the safety of adrug appears to beunprecedented.

There have been no similarcases filed in the U.S. against anyof Canada’s other major universi-ties with medical research facul-ties, based on a search of the U.S.court system’s electronicdatabase.

At the moment, the three Ham-ilton organizations are named asdefendants in two of the Pradaxalawsuits but it’s expected thatonce some legal technicalitieshave been settled, they will likelybe added as defendants in all of thePradaxa cases now pending in theU.S.

“We fully intend to defend thisimportant medication againsteach and every product liabilitycase,” Boehringer Ingelheim saidin a statement released by SaraMcClelland, director of communi-cations for Boehringer Ingel-heim’s Canadian operation, whichhas its head office in Burlington.

“We are confident that the evi-dence reviewed during the litiga-tion process will show that Boehr-inger Ingelheim acted appropri-ately and responsibly in our re-search, development andmarketing of this importantmedication.”

Hamilton Health Sciences de-fended itself and PHRI in a briefwritten statement provided to The

Spectator.“Hamilton Health Sciences has

every confidence in the conductand integrity of the research of thePopulation Health Research Insti-tute,” HHS stated. “Because thismatter is before the courts, wecannot provide furthercomment.”

McMaster spokesperson GordArbeau said university lawyersare reviewing the lawsuit claims.

“The university has every confi-dence in the quality of researchthat’s conducted by the institute,”said Arbeau.

“This matter is before the courtsand so we’ll wait and see how itproceeds.”

The judge overseeing the caseshas selected four so-called “bell-wether trials” to proceed from thenearly 2,300 lawsuits filed andwhat happens with those fourcases could lead to a quicker reso-lution of all the suits.

The first bellwether trial isscheduled to begin Aug. 11.

ATRIAL FIBRILLATION isa heart condition that becomesmore common with age. It’s esti-mated about one in 10 people overthe age of 80 lives with theproblem.

The four chambers of the heartare choreographed with electricalimpulses to pump in a precisesequence.

Sometimes the electrical charg-es to the two upper chambers, theatria, get out of whack. Instead ofbeating rhythmically, they flutterquickly and that disrupts the pushof blood into the larger lowerchambers, called ventricles.

With atrial fibrillation, bloodthat isn’t pushed out can pool in ti-ny pockets and when stagnantblood pools in one place, clots canform. In the worst cases, a clot canget pumped out of the heart, travel

up an artery, lodge in the brainand cause a stroke.

The traditional therapy to pre-vent blood clots in people withatrial fibrillation has been warfa-rin, commonly used since the mid1950s.

The formation of a blood clot in-volves a long, complicated path-way that co-ordinates the releaseof different substances in a partic-ular order. Some of these sub-stances are dependent on vitaminK and warfarin acts by inhibitingthe vitamin K part of the clottingpathway.

The biggest downside to warfa-rin is that it can be difficult to man-age the proper dosage.

An increase in vitamin K in thediet — found in leafy green vegeta-bles, for example — will decreasethe anticlotting action of warfarin,so blood levels of the drug need tobe monitored frequently. Toomuch warfarin, on the otherhand, can cause unexpectedbleeding.

On the plus side, if there is anexcess of warfarin that leads todangerous bleeding, doctors havean antidote available — a dose ofvitamin K.

Physicians — and pharmaceu-tical companies — had beenlooking for an anticoagulant sub-stitute that would provide thebenefits of warfarin without thehigher risk of bleeding or the needfor vigilant monitoring of a pa-

tient’s blood levels.Building a better anticoagulant

has also long been an area of inter-est for Hamilton’s cardiovascularresearchers.

Pradaxa, which can be takenorally and doesn’t require con-stant monitoring like warfarin,seemed to be the answer. Becauseit works on a different part of theclotting pathway, Pradaxa isn’t asdependent on diet or vitamin Klevels.

There is one big drawback withPradaxa, however.

Unlike warfarin, it doesn’t havean antidote, so it’s more difficult tostop a case of unexpectedbleeding.

Proof that Pradaxa workedcame from a large worldwide clin-ical trial that was led by a team ofresearchers from the PopulationHealth Research Institute, whichfalls under the umbrella of Hamil-ton Health Sciences and is operat-ed jointly with McMaster.

The RE-LY trial — the acronymfor “Randomized Evaluation ofLong-Term AnticoagulationTherapy” — involved about18,000 patients in 44 countries.

The trial was divided into threearms: a group that received 110milligrams of the drug twice daily,a group that received 150 mg twicedaily and a group that received thestandard warfarin treatment.

The reviews from the trial wereglowing.

Dr. Stuart Connolly, McMas-ter’s head of cardiology and one ofthe trial’s lead authors, called RE-LY “a landmark study” with “anearth-shattering result.”

Dr. Salim Yusuf, head of PHRIand another of the RE-LY trial’slead authors, said “the most im-portant thing is that this is going tobenefit patients.”

Both Connolly and Yusuf de-clined to comment beyond thewritten statement provided byHHS.

Based on the findings of the tri-al, the U.S. FDA and Health Cana-da approved Pradaxa in October2010 for the reduction of stroke inatrial fibrillation patients.

But some of the FDA’s own in-ternal documents show that is-sues had been raised about thequality of data from the RE-LY tri-al before Pradaxa was approvedfor use.

In February 2010, the FDAturned down Boehringer Ingel-heim’s first attempt to get the drugapproved because of errors thatwere found in the data sets.

AN FDA REVIEW foundtranscription errors, transposi-tion errors and auditing errors inthe data sets from patients in thetrial.

The FDA was also concernedthat there was a large discrepancyin the number of adverse eventsbeing reported in the Hamiltondata versus Boehringer Ingel-heim’s data.

Accurate reporting of the num-ber and severity of adverse eventsis crucial in a clinical trial becausethose numbers have a vital bear-ing on whether the drug isdeemed safe and effective.

“Although we recognized thatthere will be some errors in the da-ta sets from large trials,” the FDAreported, “the errors found by rel-atively unsophisticated means inclinically important data sets dur-ing preliminary review called intoquestion the overall quality ofthose data sets and our confidencein them.”

The FDA then conducted anon-site inspection of Hamilton’sPHRI and found a number of defi-ciencies, including the observa-tion that there was no data man-agement plan in place for the trialuntil 11 months after the first pa-tients were enrolled.

“The most notable finding fromthe inspection at PHRI was lack ofwritten procedures and manualsfor key aspects of the study suchas monitoring, data management,and adjudication,” the FDA reportconcluded.

Pradaxa: ‘A safety issue, a public health issue’Pradaxa continued from // A1

CHRIS NAFFZIGER, SPECIAL TO

THE HAMILTO

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The battleground: The court in East St. Louis, Ill., is located in the most dangerous city in the United States.

The drug: Pradaxa, originally known as Pradax, is an anticoagulant hailed bysome heart specialists. But now 2,300 U.S. lawsuits question its safety.

“The errors found byrelativelyunsophisticatedmeans in clinicallyimportant data setsduring preliminaryreview called intoquestion the overallquality of those datasets and ourconfidence in them.”FDA REPORT Pradaxa continues // A11

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“Additionally, the contract whichdelegated many study functionsto PHRI was not signed until al-most two years into the study.”

Despite the problems uncov-ered, the FDA allowed BoehringerIngelheim and PHRI to go backthrough the data and resubmit it.

Eight months later, the FDA ap-proved Pradaxa for use.

Almost instantly, the drug be-came a runaway success, helpedimmeasurably by the company’saggressive marketing campaign.

In the first two years, nearlyfour million prescriptions for Pra-daxa were filled in the U.S. alone.

Documents show that Boehrin-ger Ingelheim had reportedlyspent $464 million promotingPradaxa in 2011, including the costof advertising and more than amillion “detailing sessions” withphysicians, which are used to edu-cate doctors about the product.

Within a few weeks of Pra-daxa’s approval, however, analarming number of adverseevents were being reported to theU.S. FDA.

By the end of 2011, Pradaxa hadjumped to the top of the list as thedrug responsible for the most ad-verse events reported directly tothe FDA by health professionals— almost twice as many as thenext highest drug.

An analysis of adverse events in2011 showed that Pradaxa wasconnected to 542 deaths, almost2,400 cases of bleeding, nearly 300cases of acute kidney failure, morethan 600 cases of stroke and 15cases of acute liver failure.

In an article last year in the jour-nal Circulation, a prominent Har-vard Medical professor suggestedthe FDA may have been missingimportant signs about the dangersof Pradaxa because of the way thatdata was being analyzed. In con-cluding that Pradaxa was noworse and perhaps even betterthan warfarin, he said the FDAhadn’t been making apples-to-ap-ples comparisons by properly ad-justing its stats for the age andgender of patients.

The data also may not have beentaking into account the severity ofthe adverse events.

Based on an analysis of hemor-rhage cases, a report published inJanuary 2013 by the nonprofit In-stitute for Safe Medication Prac-tices showed that the chances of ableed resulting in the death of apatient were much higher withPradaxa than warfarin.

Last month, the FDA an-nounced it will conduct a newsafety assessment of Pradaxathrough a painstaking review of a

massive database that holds infor-mation from 100 million patients.

IT’S HARD to imagine a moreunlikely place for a high-stakes le-gal battle to unfold than East St.Louis, Ill.

A former industrial hub nestledagainst the Mississippi, the cityhas watched its industry, its busi-nesses and its residents flee.

In the past 50 years, the city’spopulation has dropped by nearly70 per cent. Of those who stuckaround, 98 per cent are black,nearly half of its residents live inpoverty, according to the U.S. Cen-sus Bureau, and the odds of beinga victim of a violent crime are onein 17.

When a number of liability law-suits related to the same productstart popping up in the U.S., theAmerican court process allowsfor all of the cases to be transferredto one district and consolidatedunder the direction of a singlejudge.

In the case of Pradaxa, theSouthern District of Illinois waschosen as the venue and Judge Da-vid R. Herndon was selected tooversee the lawsuits, a pile thatgrows by about 30 new cases ev-ery week.

Herndon is no stranger to thesetypes of multi-district litigationcases, as they’re known in the U.S.He was the judge who ruled onthousands of cases related to thebirth control pills Yaz and Yasminthat resulted in a payout of morethan $1.2 billion by the Bayer drugcompany.

The first lawsuits against Pra-daxa were filed in March 2012 inLouisiana, Tennessee andKentucky.

As the co-ordinator responsiblefor the RE-LY trial, Hamilton’sPopulation Health Research Insti-tute is considered a “contract re-search organization,” and under

FDA regulations, a CRO — evenone outside the U.S. — is subject toAmerican jurisdiction if it hasbeen involved with a product thatlater faces liability claims relatedto safety.

The two lawsuits directly nam-ing McMaster, HHS and PHRIwere filed last July 11 and 12 — thefirst by Samuel Richardson ofCastlewood, Va., and the secondby Billie Jean Benitez of Fair Oaks,Calif.

Richardson claims he sufferedserious gastrointestinal bleedingthat required “multiple life-savingefforts.” Benitez also claims tohave suffered gastrointestinalbleeding serious enough that shewas hospitalized for a month.

The two lawsuits allege Mc-Master, HHS and PHRI “derivedsubstantial profit from its collabo-ration and administration of theRE-LY trials in the United States.”

“On information and belief,”the lawsuits allege, “HHS and Mc-Master University through PHRIknew that data collected in theRE-LY trial was tainted and yet,held it out as valid and relied onsaid data to gain FDA approval,thereby enriching both PHRI andthe (Boehringer Ingelheim) defen-dants, while accomplishing theirgoal of getting a dangerous drug tomarket without accurate and/oradequate testing.”

The lawsuits also allege that“HHS and McMaster Universitythrough PHRI negligently failedto properly maintain data relatedto the RE-LY trial, which calls intoquestion the dependability andsoundness of the RE-LY trialmethodology and results.”

The lawsuits also claim that theEuropean Medicines Agency —Europe’s equivalent of the FDA —found that “PHRI had numerous‘shortfalls and weaknesses’ intheir ‘processes and errors in(their) data.’”

Denton, lead lawyer for theplaintiffs, said he’s “absolutely”confident the allegations madeagainst Boehringer Ingelheim andthe Hamilton organizations willbe proven true.

Boehringer Ingelheim defend-ed the RE-LY trial and its resultsin its statement issued to TheSpectator. “We stand firmly be-hind the safety and efficacy of Pra-daxa, based on the findings of thisextensive research,” the compa-ny’s statement said.

“Any suggestion that data onPradaxa was suppressed is de-monstrably false and withoutfoundation.

“The safety and efficacy of Pra-daxa have been well-studied inmore than 40,000 people world-wide,” Boehringer Ingelheimnoted.

“Both the FDA and EMA havepublicly reaffirmed that Pradaxaprovides an important health ben-efit when used as directed to re-duce the risk of stroke in patientswith atrial fibrillation.”

MCMASTER ALSO defend-ed the Population Health Re-search Institute.

“We know the institute has ahigh degree of integrity in how itconducts its research and thechecks and balances that it followsto ensure the integrity of itswork,” said Arbeau, the universi-ty spokesperson.

Lawyers for the plaintiffs havebeen conducting witness deposi-tions in the U.S. and Europe, andit’s expected that depositions willeventually be taken from re-searchers in Hamilton.

As of September, BoehringerIngelheim had already producedthe equivalent of about 32 millionpages of documents at a cost ofmore than $24 million.

Even still, the fight over docu-ment disclosure during what’sknown as a lawsuit’s discoveryprocess has been particularly acri-monious between the plaintiffsand the drug company.

Frustrated with ongoing prob-lems with the disclosure of evi-dence, lawyers for the plaintiffsfiled a lengthy motion in late fallseeking sanctions against Boehr-inger Ingelheim.

Judge Herndon had alreadyfined the company nearly $30,000three months earlier over similarissues and almost immediately af-ter that ruling, lawyers for theplaintiffs were alleging thatBoehringer Ingelheim was repeat-ing the same behaviours.

The most egregious problem,the plaintiffs claimed, was that thedrug company had failed to notifythe plaintiffs about the existenceof a German professor who wasintimately involved with the de-velopment of Pradaxa. In one in-ternal email, the professor waseven described as the “companyexpert” on the drug.

Yet it was only by accident dur-ing the deposition of another em-ployee that the plaintiffs’ lawyerslearned about the professor.

The plaintiffs’ lawyers also dis-covered that many key documentsassociated with the professor,such as emails and text messages,hadn’t been retained by the com-pany as required by law.

The company also had to ac-knowledge that it supplied em-ployees with smartphones thatwere automatically programmedto delete text messages, eventhough text messages should havebeen saved as part of the evidencedisclosure process. More damag-ing still was a document showingthat the company directed its salesforce to use text messages —which are more difficult to trackelectronically — as the means tocommunicate with supervisorsand district managers.

All that was on top of the hun-dreds of thousands of pages ofdocuments that either hadn’t beenturned over as required or in somecases turned over at the last min-ute before witness depositions.

JOHN

RENN

ISON

, THE HAMILTO

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The clinical giant: Population Health Research Institute is housed in this building at Hamilton General Hospital.

HAMILTO

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The expert: Dr. Stuart Connolly isa cardiac researcher affiliated withMac and the Population HealthResearch Institute.

SPECIAL TO THE HAM

ILTON

SPECTATOR

The expert: Dr. Salim Yusuf, headof PHRI and a lead author of theRE-LY trial, expressed optimismabout the benefits to patients.

Last month, the FDAannounced it willconduct a new safetyassessment ofPradaxa through apainstaking reviewof a massivedatabase that holdsinformation from100 million patients.

THE FOURPRADAXA TESTCASESEstate of Malachy Higgins v.Boehringer IngelheimScheduled start date: Aug. 11,2014Malachy Higgins of New York diedon Jan. 8, 2012, from seriousbleeding, two months after hefirst took Pradaxa. His daughter issuing on his behalf, seeking aminimum of $10 million indamages.

Estate of Ronald Kohn v.Boehringer IngelheimScheduled start date: Nov. 3,2014Ronald Kohn of Albany County,N.Y., died on Sept. 21, 2012 aftersuffering from abdominalbleeding. He had been takingPradaxa for about 18 months. Hiswife and three children are suingon his behalf.

Georgia Primus v. BoehringerIngelheimScheduled start date: Jan. 5,2015Georgia Primus of Waynesville,Mo., began taking Pradaxa inMarch 2012. On July 5, 2012, sheshowed up in hospital sufferingfrom a serious case ofgastrointestinal bleeding.

Helen Jean Hawkins v.Boehringer IngelheimScheduled start date: Feb. 16,2015Helen Hawkins of London, Ky.,began taking Pradaxa on Feb. 7,2011. On March 8, 2011, she wasadmitted to hospital sufferingfrom life-threateninggastrointestinal bleeding.

Pradaxa continues // A12

Pradaxa continued from // A10

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Herndon blistered the companythroughout his 51-page ruling, re-leased two weeks beforeChristmas.

THE JUDGE said it was impos-sible for Boehringer Ingelheimnot to understand what docu-ments needed to be produced.

“The production requests of theplaintiffs are so broad as to coverany possible derivation of meansto document someone’s thoughts,words and deeds short of attach-ing electrodes to their scalps andelectronically downloading whatis contained in their minds,” theexasperated judge wrote.

He found that BoehringerIngelheim had acted in bad faith,had violated court orders and heeven came within an inch of sug-gesting the company had been un-truthful, stating instead thatBoehringer Ingelheim had made“misrepresentations,” both inopen court and in the judge’schambers.

Herndon fined the company$931,500, which represented $500for each of the 1,863 cases thatwere pending at the time. He alsoheld open the possibility that hewould resort to even strongersanctions if the problemscontinued.

Meanwhile, the Pradaxa litiga-tion rumbles on with the first trialjust six months away.

The case of Malachy Higgins ofthe State of New York versusBoehringer Ingelheim beginsAug. 11.

No matter what the result, it willcome too late for Higgins.

He died on Jan. 8, 2012, twomonths to the day after he firststarted taking Pradaxa.

Pradaxa:The firsttrial is justsix monthsaway

Pradaxa continued from // A11

sbuist@thespec.com905-526-3226

“We stand firmlybehind the safetyand efficacy ofPradaxa, based onthe findings of thisextensiveresearch.”PHARMACEUTICAL COMPANYBOEHRINGER INGELHEIM

HAMILTON SPECTATOR FILE PHOTO

Dream drug? Pradaxa, whichdebuted as Pradax, was originallyhailed by some heart specialistsas a dream come true.

FOR THE PAST three de-cades, many Britons hadhoped the rigid class sys-

tem that defined their countryfrom Dickens to Downton Abbeywas finally dying.

Now they fear that class is backon the rise.

From 1979, Britain was led formore than a decade by MargaretThatcher, a grocer’s daughter,and then by John Major, the sonof a music-hall entertainer.

The current leader, DavidCameron, is a descendent of KingWilliam IV whose cabinet isstacked with men, like him, fromthe country’s toniest privateschools and Oxford and Cam-bridge universities.

Even entertainment has amore upper-crust flavour thesedays. A recent Sunday Telegraphstory, with the headline Young,gifted and posh, said Britain’soldest private schools, such asall-male Eton and Harrow, hadbecome a “production line ofyoung talent,” including Home-land star Damian Lewis, Bene-dict Cumberbatch of Sherlockand Dominic West of The Wire.

Major, alarmed by the appar-ent reversals, recently sparked aflurry of debate with a speechthat made front-page headlines.

“In every single sphere of Brit-ish influence, the upper echelonsof power in 2013 are held over-whelmingly by the privately edu-cated or the affluent middleclass,” Major said. “To me, frommy background, I find that trulyshocking.”

So is it true that class divisionsare deepening again?

While the ancestral uppercaste still retains its mystique inBritain, the numbers reflect amore complicated reality. Anelite still dominates, but it is nowa club where money — and theeducation money can buy —counts more than lineage.

This means more women, eth-nic minorities and foreignershave made it to the top.

But the increase in diversitymasks the fact that it’s becomingharder for the poor and uncon-nected to climb the social ladder.

A new wealthy classWhen the Sunday Times

newspaper published its first an-nual Rich List in 1989, Britain’swealthiest individual was QueenElizabeth II.

The top 10 was a snapshot of anelite heavy on titled back-grounds, clubby connectionsand inherited wealth.

The 2013 list is a rollcall of in-ternational capitalists who havemade London their base. Eventhe Queen has dropped out.

The top 10 now includes Uzbekmining magnate Alisher Usma-

nov; Indian industrialists Sri-chand and Gopichand Hinduja;Chelsea Football Club’s Russianowner, Roman Abramovich;Norwegian shipping tycoon JohnFrederiksen’ and Heineken beerheir Charlene de Carvalho.

Philip Beresford, who assem-bles the list, told the BBC: “WhenI first started 25 years ago abouttwo-thirds of the rich list werepeople who had inherited theirwealth. Today, approaching 80per cent are self-made and that’sreally a legacy of the Thatcheryears."

Prestige and politicsIf business has grown more

open, many Britons express con-cern that an old upper class is re-asserting itself at the top ofpolitics.

But here too the picture is morenuanced.

While Britons may focus onthe aristocratic lineage of Camer-on and his finance minister,George Osborne, they often over-look a new category of career pol-iticians, many of them wealthy

individuals with school connec-tions.

And while gender and ethnicdiversity have grown, the partici-pation of working-class candi-dates who enter politics afterholding “real world” jobs haswithered.

When Thatcher became primeminister in 1979, she was one ofonly 19 women in the House ofCommons.

Not one lawmaker out of morethan 600 came from an ethnic mi-nority.

Almost half had attended pri-vate schools, while 36 per centwent to Oxbridge, as Oxford andCambridge are known.

The lawmakers included 96lawyers, 49 teachers and 138businesspeople — but also 98manual workers, including 21former miners.

In the current parliament, 22per cent of legislators are womenand 4.2 per cent are from an eth-nic minority. There are stillscores of lawyers and business-people, but only 25 former manu-al workers.

The song and danceIf the bastions of business, pol-

itics and the professions werehard for working-class people tostorm, there was alwaysentertainment.

You don’t need money or a de-gree to be a movie star or playrock ’n’ roll.

Or do you?Britain’s leading actors appear

to be drawn from a smaller poolcompared to a generation or twoago.

In a list of actors with the high-est box-office earnings, there are10 Britons in the top 50.

The older end of the list in-cludes actors from working-classbackgrounds such as MichaelCaine, son of a fish-market por-ter, and 55-year-old Gary Old-man, son of a sailor and a Londonhousewife.

As the list gets younger, itclimbs the social scale: RalphFiennes, 51, grandson of awealthy industrialist; HelenaBonham Carter, 47, whose great-grandfather was a British primeminister; and Orlando Bloom, 37,educated at private school.

Of the three young stars of theHarry Potter trio, now in their20s, Daniel Radcliffe and EmmaWatson attended private schools;Rupert Grint went to a stateschool.

“I look at almost all the up-and-coming names and they’refrom the posh schools,” actressJulie Walters said recently.

“Don’t get me wrong ... they’rewonderful. It’s just a shame thoseworking-class kids aren’t comingthrough. When I started, 30years ago, it was the completeopposite.”

If actors are becoming posher,surely there’s still plenty of roomfor working class heroes in popu-lar music?

The bestselling British artistsof all time, are The Beatles, LedZeppelin, Pink Floyd, Elton Johnand the Rolling Stones — oftenself-taught musicians, mostlyfrom lower- or middle-classbackgrounds who worked theirway up from small, smoky clubsto the big time.

But that was decades ago.For every working-class singer

made good, such as Adele, there’sa posh, privately educated Cold-play or Mumford & Sons.

That leaves sports — especiallysoccer — as the one arena whosestars are overwhelmingly work-ing class.

Sport provides a parallel elite,complete with an honorary king,David Beckham, who is hand-some and regal.

But in the parallel universe ofsport, only a tiny minority of themost talented can even hope tomake a living.

NICK BRIGGS, THE CAN

ADIAN PRESS

How the other half lived: Laura Carmichael as Lady Edith in Downton Abbey is escorted into a vehicle worthy of her station in life.

THEGREATDIVIDEClass is back on the rise in Britain, ineverything from politics toentertainment, despite hopes frommany Britons that it was on its way out

JILL LAWLESS

The Associated Press

KIRSTY WIGGLESW

ORTH, THE ASSO

CIATED PRESS

Not amused? Back in 1989, Britain’s wealthiest individual was QueenElizabeth II. Now the rich list is a roll call of international capitalists whohave made London their home. The Queen has dropped out.