2010 biggest stories

8/8/2019 2010 Biggest Stories

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The most important healthcare stories in 2010

December 6, 2010 The Healthcare Channel

2010 was a more positive year for American healthcare than recent years. The

stock markets were less volatile and the big cloud of uncertainty related to healthcarereform was out of the way, or so it seemed. There was no global pandemic his year likethe swine flu of 2009, and fewer jobs in Big Pharma were eliminated as M&A settleddown from the record pace of last year.

Several major advancements in clinical care occurred during 2010, as well as newrisks and uncertainties developing. The Healthcare Channel has narrowed down the mostimportant events of 2010 to the following:

#17 Boston Scientific loses a $1.7 Billion patent lawsuit to Johnson and Johnson : Inwhat would become the only good news for JNJ this year, BSX lost yet another billion-plus lawsuit. This time, the courts ruled that BSX's stents violated

IP owned by JNJ. The loss caused the company to sell more assetsin order to meet 2011 loan obligations stemming from theoverpriced Guidant acquisition.

Meanwhile, the new BSX CEO, Ray Elliott, seems to bedoing an adequate job at turning around the distressed companyand making smarter strategic acquisitions. For his effort, he islisted again this year by the NY Times and WSJ as one the highestcompensated CEO's.

#16 Genzyme woes, Carl Icahn, and Sanofi-Aventis takeover bids: The GENZAllston manufacturing plant inspection problems of 2009

continued into 2010 with a formal consent decree (as The HCCpredicted). As a result, a global shortage ofCerezyme to treatGaucher disease developed. This opened the door forcompetitors, Shire's Vpriv and Protalix BioTherapeutics'Taliglucerase, to fill the demand for Gaucher disease enzymereplacements.

Sensing an undervalued company hindered by bad management, activist investorCarl Icahn swooped in, gained control of the board, and started to position the companyfor sale. Taking the bait, Sanofi-Aventis, suffering setbacks in its own pipeline, made anoffer to buy GENZ for $18.5 Billion, which was declined by Icahn

#15 Large DOJ fines to Big Pharma for bad practices: The Department of Justicesettled numerous Big Pharma investigations with fines close to a billion dollars.GlaxoSmithKline settled for $750 M, AstraZeneca for $520 M, JNJ is rumored to beclose to settling the Risperdal marketing kickback probe, and in 2009, PFE and LLYwere stuck with tabs exceeding $1 Billion. Those are significant amounts even for BigParma.

Some critics in the media said that this was indicative of the anti-business policiesof the Obama administration, while others said that financial fines were not enough of a
http://online.wsj.com/article/SB10001424052748704393604575614852198144276.html?KEYWORDS=highest+paid+CEOhttp://www.reuters.com/article/idUSN2620418520100226http://www.protalix.com/glucocerebrosidase.htmlhttp://www.protalix.com/glucocerebrosidase.htmlhttp://www.reuters.com/article/idUSTRE67T1JL20100830http://online.wsj.com/article/SB10001424052702304879604575582603173894296.html?KEYWORDS=glaxo+750http://www.reuters.com/article/idUSTRE63Q49J20100427http://www.fiercepharma.com/story/jj-jnj-talks-risperdal-marketing-settlement/2010-11-11?utm_medium=rss&utm_source=rsshttp://www.fiercepharma.com/story/jj-jnj-talks-risperdal-marketing-settlement/2010-11-11?utm_medium=rss&utm_source=rsshttp://www.reuters.com/article/idUSTRE63Q49J20100427http://online.wsj.com/article/SB10001424052702304879604575582603173894296.html?KEYWORDS=glaxo+750http://www.reuters.com/article/idUSTRE67T1JL20100830http://www.protalix.com/glucocerebrosidase.htmlhttp://www.reuters.com/article/idUSN2620418520100226http://online.wsj.com/article/SB10001424052748704393604575614852198144276.html?KEYWORDS=highest+paid+CEO


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Wall Street Journal

penalty to dissuade executives from repeating the behavior and called for real jail time. Alarge criminal investigation related to bribery of overseas doctors and officials by thedrug industry is ongoing. A similarprosecution into the medical deviceindustry did lead to jail time for one

JNJ executive. The FDA has alsoopened a criminal investigation of itsown into JNJ related to Puerto Ricoplant drug recalls (see JNJ recall storybelow).

#14 Better, smaller, safer LVADs:The heart pumping assist devices known as LVADs, like the one implanted in Vicepresident Dick Cheney, continued to evolve with impressive data on the HeartWare(HTWR) centrifugal pump. Thoratec tried to acquire HTWR but was not allowed by theFTC. Since the HeartWare device is smaller, longer lasting, easier to implant, and has

less infection than the current state-of-the-art ThoratecHeartMate 2, THOR shares saw a beating.The remaining issues to be resolved with these devices

are unique coagulopathies caused by the rapidly spinning pumpsthat break down clotting molecules resulting in GI bleeding andstroke. However, when compared to death caused by lack ofdonor heart transplant supply, LVADs are major advancementfor heart failure.

#13 Heart valves implanted without open-heart surgery: The first pivotal trial onminimally invasive aortic valves was published this year. The trial was conducted by

Edwards Lifesciences (EW) and was called PARTNER. This first version of the trialcompared the Sapien valve to an easy-to-beat controlcohort of valvuloplasty. The tougher comparison tomore effective traditional open-heart valve surgery ispending. The remaining serious issue that needs to beresolved with these catheter-based valves is theproblem of embolic stroke. Nevertheless, this studyrepresents one of the most effective new therapiesever in the field of interventional cardiology.

The cardiac surgeons and the cardiologists will be fighting turf wars as thesedevices develop. The larger cardiology community will likely win unless the stroke

problem via catheter implantation is insurmountable. Stay tuned.
http://www.reuters.com/article/idUSTRE68M1QN20100923http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=1&scp=1&sq=bribery%20clinical%20trials&st=cse


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ABC

#12 Failure of magic pills for weight-loss: With projections that half of Americans willbecome Type-2 diabetics within our lifetimes, a magic pill that would reduceuncontrollable gorging of junk food would be a blockbuster new drug class.Unfortunately, three potential weight-loss drugs were rejected by the FDA in 2010. FDAadvisory committees rejected Vivus's (VVUS) Qnexa and Arena Pharmaceutical's

(ARNA) lorcaserin. Abbott's Meridia, already on the market but plagued by safetyconcerns, was officially pulled from the market. The embarrassing heart valve safetyproblems that arose from Fen-Phen have increased the safety bar for the FDA.

The one bright moment for this drug class arose when the OrexigenTherapeutics (OREX) AdCom voted to approve Contrave (naltrexone SR/bupropionSR) with post marketing safety studies.

#11 Diabetes drug scandals and rejections: The Avandia (rosiglitazone) safety tug-of-war between the cartel opposing Avandia, led by Steve Nissen, and proponents led byGlaxoSmithKline, resulted in a second FDA AdCom voting to keep the drug on the

market. The FDA followed up the AdCom with strict prescribing

guidelines, or REMS. All of this undoubtedly impacted theregulatory fate of the Amylin (AMLN)/Eli Lilly (LLY) drugBydureon (long-acting exanatide), which was delayed by theFDA yet again.

The entire class of Type-2 diabetes drugs is becoming aless desirable market for Big Pharma as the FDA has issuedguidance documents for stricter safety standards in clinical trial.To learn more, see The HCC interview with The CDER Directorand numerous other expert interviews this year.

#10 Johnson and Johnson OTC drug recalls: The Golden Child, JNJ, once known as

having the best brand in industry, fell from grace with congress as problems with PuertoRico manufacturing plants led to numerous recalls of OTC drugs like Children's Tylenol.Members of congress pounced upon the big corporation much as they did with GoldmanSachs and dragged the CEO, Bill Weldon, before an oversight panel.

More recalls are still being announced almost weekly, and senior JNJ executiveshave already lost their jobs. Once one of FortuneMagazine's "50 most powerful women in business",head of JNJ global consumer products, ColleenCoggins, was sacrificed to the gods of congress. It isrumored that the 61-year-old CEO might be the next toretire.
http://www.reuters.com/article/idUSTRE6AM0NH20101123http://www.reuters.com/article/idUSTRE6AM0NH20101123


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NY Times

#9 CT scan screening of lung screening saves lives: After decades of controversywhether screening smokers with costly radiation emitting CT scans really helps to reducemortality in smokers, the definitive NIH trial demonstrated benefit in the cohort screenedwith CT scans. The champion of this concept, Dr. Claudia I. Henschke, had receivedmuch criticism in the press and academic

literature over the years. Her researchmethods, financial conflicts, and personalintegrity were all questioned. The NIH studyserves as a vindication late in her career,somewhat.

#8 Amgen's denosumab prevents complications from bone mets: Amgen's (AMGN)large molecule antibody drug branded as Prolia and Xgeva met the primary endpoint inthe trial studying the cancer indication of preventing complications from bone metastases,or skeletal related events (SRE). Prolia is already approved to prevent post-menopausalosteoporosis (PMO). If the data remain robust upon complete publication, this will be

another major clinical advance made in the year 2010.In addition to the cancer indication, the PMO indication was

indirectly helped by new warnings on the bisphosonate class of drugs.Long-term use, more than four years, appears to cause the bones tobecome brittle. The femur and hip can fracture with normal exertion.Prolia does not appear to have such a complication.

#7 Prophylactic Truvada lowers chance of getting HIV in gaymen: In a landmark NIH study, Gilead's (GILD) combo-HIV pillTruvada reduced the risk of contracting HIV in men having sex withmen. Anti-retrovirals have been used to prevnt HIV infection after needle stick injuries or

sex, but this is the first study of its kind to show that prophylactic use is effective.

#6 Insider trading in healthcare sector stocks: In November, the Wall Street Journalbegan breaking a series of stories related to consulting firms supplying insiderinformation to hedge and mutual funds. Many of the trades causing arrests andinvestigations deal with M&A of healthcare stocks or clinical data from pivotal trials. Ifthe investigations lead to arrests of senior hedge fund titans, this could become thebiggest Wall Street criminal prosecution ever.
http://www.nlm.nih.gov/medlineplus/news/fullstory_105177.htmlhttp://www.businessweek.com/lifestyle/content/healthday/644359.htmlhttp://www.nejm.org/doi/pdf/10.1056/NEJMoa0906768http://online.wsj.com/article/SB10001424052748704170404575624831742191288.html?http://online.wsj.com/article/SB10001424052748704170404575624831742191288.html?http://www.nejm.org/doi/pdf/10.1056/NEJMoa0906768http://www.businessweek.com/lifestyle/content/healthday/644359.htmlhttp://www.nlm.nih.gov/medlineplus/news/fullstory_105177.html


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#5 Awareness of the cancer risk from radiation delivered by medical imaging: Asthe usage of CT scans and other medical imaging has skyrocketed over the last 15 years,only recently has it been learned that the radiation doses are comparable to levels seen in

Hiroshima and Nagasaki atom bomb survivors. Dental practices alsouse 3-D imaging that deliver high doses of radiation. In the wake of

publicized tragic radiation overdoses from CT scans, the FDA hastaken measures to strengthen safety of the devices.

Not only can medical imaging be harmful to the patient, butit has ballooned into one of the largest expenditures in Americanhealthcare. The Healthcare Channel was the first to discuss thisissue in 2007. Our most recent interview with Bruce Hillman, MD,

Editor-in-Chief of The Journal of the American College of Radiology (JACR), discussesthe problem and what the radiology community plans to do about it.

#4 Record prices set for newly approved drugs: Several new categories of drugs wereapproved to treat unmet medical needs. That was the good news. However, taking

advantage of loopholes not addressed in the ACA healthcare reform law wherebyMedicare still cannot directly negotiate drug prices, the drug companies have set everhigher prices for new drugs.

The Dendreon (DNDN) prostate cancer therapy, Provenge, which prolongssurvival by only for months if one believes the company's interpretation of the data, wasset at $93,000 for a course of therapy. Novartis' new multiple sclerosis drug, Gilenya(fingolimod), was set at more than $40,000 per year: more than the large moleculeTysabri. Bristol-Myers Squibb promising melanoma drug, Ipilimumab, is rumored tobe priced at $200,000 if it is approved.

#3 Easier to use alternatives to warfarin: With the FDA approval of Boehringer

Ingelheim's Pradaxa (dabigatran), and possible approvals ofAstaZenenca's Brilinta(ticagrelor) and Bayer/JNJ's Xarelto (rivaroxaban), numerous new alternatives to theoral anticoagulation medicine Coumadin (warfarin, or rat poison) are emerging. As everypatient on it and doctor prescribing it knows, warfarin is a very problematic drugrequiring constant blood testing.

If Pradaxa and the other drugs maintain a safe profile in the real world setting ofnon-valvular heart atrial fibrillation, then a major breakthrough in medicine will havebeen achieved, and along with it, some much needed new blockbusters for Big Pharma.To learn more, see our roundtable discussion on the matter.

#2 Passage of the ACA healthcare bill, and midterm elections: This historic event is

listed only as the second most important story of the year on our list only because of themidterm elections which promise to stall important aspects of the bill, if not outrightrepeal it. The outcome of this great fight will certainly be one of the biggest stories of2011 and the decade.
http://well.blogs.nytimes.com/2010/11/22/radiation-in-the-dentist-chair/?scp=1&sq=dental%20radiation&st=csehttp://www.currentmedicine.tv/2010/medical-centers/univ-miami-med-ctr/kottil-rammohan-md-the-new-ms-drug-gilenya-fingolimod/http://www.currentmedicine.tv/2010/specialties/cardiology/pradaxa-dabigatran-approval/http://www.currentmedicine.tv/2010/medical-centers/univ-miami-med-ctr/kottil-rammohan-md-the-new-ms-drug-gilenya-fingolimod/http://www.currentmedicine.tv/2010/other-categories/policy/bruce-hillman-md-medical-imaging-expenditure-growth/http://www.currentmedicine.tv/2010/specialties/cardiology/cardiologyinterventional/mahadevappa-mahesh-phd-the-cancer-risk-from-ct-scan-exposure/http://well.blogs.nytimes.com/2010/11/22/radiation-in-the-dentist-chair/?scp=1&sq=dental%20radiation&st=cse


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Vanity Fair

#1 Awareness of problems with outsourcing clinical trials: The number one mostimportant story for 2010 on our list is still off the radar screen for most analysts. It is theconcerning trend of Big Pharma outsourcing clinical trials used to approve Americandrugs to small third-world countries with little oversight of the trial process: humanguinea pigs.

The Healthcare Channel interviewed the author of the OIG report that detailedthis problem, then later spoke with the FDA's Director of CDER. Vanity Fair publishedan article focusing on the impact to patients andhow the integrity of the data are in question. TheWSJ reported on the expanding criminalinvestigation being led by the DOJ and SEC relatedto bribery of doctors by large pharmaceuticalcompanies.

This developing story is the most importantof the year because it impacts almost all new drugtrials. A long list of drugs pending approval were

studied in trials that provided what is now known to be questionable data given theDOJ/SEC probe. For example, AstraZeneca's blood thinner, Brilinta (ticagrelor), ispending approval. However, the U.S. and Canadian patients in the pivotal PLATO trialshowed no benefit. The study met endpoints based on the overseas cohort data.

2011 should be the year when this story develops. Register here to follow ourcoverage.
http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101?printable=true#ixzz16xNpaZi3http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101?printable=true#ixzz16xNpaZi3http://thehcc.tv/htm/register.phphttp://online.wsj.com/article/SB10001424052748704847104575532091781199092.html?KEYWORDS=Michael+Rothfeld+october+5http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101?printable=true#ixzz16xNpaZi3http://www.vanityfair.com/politics/features/2011/01/deadly-medicine-201101?printable=true#ixzz16xNpaZi3


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2010 biggest stories

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