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By Martha RosenbergNovember 15, 2011
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PART ONE
Big Pharma has been accused of affairs drugs that are so alarming they account afterlife and drugs that account the exact altitude they're declared to treat. The accepted asthma drugs Symbicort, Advair Diskus, Serevent Diskus, Dulera and Foradil do both and absolutely acquaint on their labels that they account an added "risk of afterlife from asthma problems."
Big Pharma and the FDA accept accepted for years that formoterol fumarate, activate in Symbicort, Dulera and Foradil, and salmeterol, activate in Advair Diskus and Serevent Diskus, can paradoxically account asthma deaths, abnormally in accouchement and African-Americans. In actuality the FDA has acute the warnings on the labels several times and convened several hearings about the drugs' assurance and some doctors accept alleged for their complete ban.
But the drugs, alleged connected acting beta agonists, or LABAs, are so lucrative--Advair was the fourth best affairs biologic in the US aftermost year, authoritative about $5 billion--they are marketed admitting their estimated US afterlife assessment of 4,000 a year. That's according to or alike added than the cardinal who die from asthma itself!
LABAs, whose advancing business coincided with the admission of direct-to-consumer biologic advertising, are billed as add-on drugs that amusement asthma in a altered way than acceptable steroid asthma drugs. Traditional, inhaled corticosteriods like Flovent, Pulmicort, Asmanex and Qvar amusement asthma's inflammation, while LABAs, assigned as aliment or "control" drugs, aggrandize attenuated airways and assure adjoin bronchospasm.
But abstraction afterwards abstraction appearance the "bronchoprotective" furnishings accept a downside. They can "mask" asthma that is absolutely accepting worse admitting bodies feel fine, and they can aftermath "desensitization" or "down regulation" additionally accepted as tolerance, in which the added you use them the beneath they work.
In fact, salmeterol, the biologic in Advair and Serevent, is advised so unsafe, a huge balloon alleged the Salmeterol Multi-center Asthma Analysis Trial, or SMART was concluded in 2003 afterwards there were 16 deaths, 44 intubations and 369 hospitalizations on LABAs, mostly in African-Americans.
At FDA hearings afterwards SMART, Pharma doctors accustomed to circuit the after-effects by adage the patients had been sicker to activate with, that they were too apathetic to seek medical affliction and that their self-reports of LABA use couldn't be trusted because patients lie. They additionally said (somewhat contradictorily) that LABAs don't affectation deepening asthma because patientsknow if they are accepting worse (not that they get worse!)--and the deaths can be explained by patients' DNA types. Whew. LABA defenders alike said the SMART after-effects couldn't be trusted because the balloon was chock-full early.
Usually, the absolution for alarming drugs like LABAs is that their allowances outweigh their risk. But at FDA hearings three years later, David Graham, MD, an FDA official, said LABA "benefits, if any, seemed to be baby compared to placebo." He additionally blew the blare on the boundless Pharma allegory that a abatement in US asthma deaths over the aftermost decade is due to LABAs.
"It is accurate that trend for arise asthma deaths has beneath over time," he said in the hearings. "But cipher has apparent that the abatement has annihilation to do with LABA use." Fifty percent of the abatement "is due to the change in allocation coding from IC-9 to ICD-10," said Graham, accepted for testifying afore Congress about Vioxx dangers.
While the cardinal of asthma deaths is down, the cardinal of asthma sufferers is growing--and no one absolutely knows why. Some adduce added pollens in the air from all-around warming, an balance of abhorrence causing constituent air fresheners and the "hygiene theory" that we accept created such a antibody and clay chargeless environment, our allowed systems can't differentiate absolute threats from controllable pollens or dust.
Others adduce beginning decree biologic use. Advisers at Henry Ford Hospital activate accouchement accustomed antibiotics aural their aboriginal six months of activity were added acceptable to advance allergies. Abstracts presented at the American Academy of Allergy, Asthma & Immunology advance accouchement whose mothers took decree acid-blocking drugs like Nexium during abundance are added acceptable to ache affection of asthma. And analysis in the American Account of Respiratory and Critical Affliction Medicine activate that Tylenol may be, "an important accident agency for the development and/or aliment of asthma, rhinoconjunctivitis and eczema in boyish children." Alike statins accept been indicted. Meanwhile, a 1999 European Union address speculates about the role of sex hormones and meat additives in asthma.
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To prove that LABAs are safe and effective, Pharma not abandoned credibility to falling US asthma deaths rates, it credibility to LABAs' admittance in government asthma guidelines. Alike admitting Pharma doctors around wrote the government guidelines!
William W. Busse, MD, from the University of Wisconsin Academy of Medicine and Accessible Health, chaired the able console which developed the government's 2007 National Asthma Education and Prevention Program Guidelines--even admitting he is financially affiliated to GlaxoSmithKline, Merck, Novartis, Pfizer Genentech/Novartis, Schering and bristles added Pharma companies. According to the guidelines themselves.
No admiration federal guidelines acclaim the "established benign furnishings of LABA for the abundant majority of patients who crave added analysis than low-dose ICS abandoned to ascendancy asthma," and alarm LABAs a "preferred option" that "improves lung function, decreases affection [and] reduces exacerbations!" Not that we accept an opinion.
Why is a Pharma doctor autograph federal ache analysis guidelines? And why, on top of 10 Pharma backers, does he accept "research abutment from the NIH" which is our tax-dollars? Aren't abundant tax dollars affairs Medicare and Medicaid-reimbursed LABAs acknowledgment to the "guidelines"?
Since SMART and added arise deaths, the FDA has connected to authority hearings and bind warnings. Currently, warnings say LABAs should abandoned be acclimated aback inhaled corticosteriods don't ascendancy asthma, and for the beeline time accessible and should not be acclimated afterwards corticosteriods or as a "rescue" medication.
Needless to say, if LABAs accept to be acclimated in accession to inhaled corticosteriods and in accession to accomplishment inhalers (like Proventil HFA, ProAir HFA, Ventolin HFA) what they are absolutely acceptable for is not clear--even as Pharma sells a third, possibly surplus drug. No admiration Forbesmagazine calls the LABA-containing Advair, "more a phenomenon of business than of science." Abounding additionally catechism whether the accession of an inhaled corticosteroid, which Symbicort, Dulera and Advair have, alike makes them safer.
Of course, LABA promoters are bent about the admonishing that LABAs should not be acclimated connected term. "Suddenly endlessly medication that is accouterment a aegis for individuals--without acceptable abstract acquaintance to aback it up--is commodity we're actual anxious about," said William Busse at an asthma conference. And aback the FDA arise this year it will retest LABAs, Busse cowrote an affronted letter to the New England Account of Medicine. New trials are accidental he said and calling them "'safety' studies suggests that LABAs accept some absolute toxicity that causes afterlife or leads to hospitalization."
Some bodies adulation LABAs and affirmation their asthma affection accept gone away. But the best they use them, the added acceptable they are to address Advair or Symbicort "poop-out" (like "Prozac poop-out") in which the biologic stops alive and they feel worse than before.
On the drug-rating web armpit askapatient.com, patients additionally address activity "addicted" to the drugs and that their lung accommodation is changing. "My lungs feel altered than normal, like my lungs are activity broiled out and adhesive if that is possible, all at the aforementioned time, letters one actuality about Symbicort. "It seems they are acceptable lazy, like now they cannot absence a dose."
"When I sucked it in, it acquainted like I was annoyed my lungs," says an Advair user in Forbes. The man's doctor told him the biologic "couldn't possibly be authoritative him worse," but it was.
Twenty-five patients on Advair Diskus 100/50 additionally address antagonism and aberrant affection beats, palpitations and the activity of an approaching affection attack.
PART TWO
Long acting beta agonists as activate in Symbicort, Dulera, Foradil, Advair Diskus and Serevent Diskus, (LABAs) are not the abandoned asthma drugs with ambiguous assurance and capability that accept become billion dollar businesses for Pharma. Singulair, a leukotriene receptor adversary or LTRA, was the nation's seventh best accepted biologic aftermost year, according to IMS bloom and becoming added than $4 billion. It ranks abandoned two places beneath Advair in sales. Added LTRAs are Accolate and Zyflo.
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Singulair is heavily marketed to kids for allergies, in accession to asthma, and alike comes in a cherry-flavored chewable formulation. Business included a affiliation with Olympic gold-medalist swimmer Peter Vanderkaay, a basketball "skills challenge" for kids 9 to 14 and abstracts broadcast through (and legitimized by) Scholastic and the American Academy of Pediatrics, said arise reports.
Sales pieces from Scholastic and Merck (who makes Singulair) called, "Health Ed 101-- Learn to Prevent Asthma Symptoms," told parents, "When your adolescent breathes in an asthma trigger, such as pollen from copse or weeds, the anatomy releases leukotrienes (loo-ko-TRY-eens)" and that Singulair blocks the loo-ko-TRY-eens.
The Scholastic sales allotment says Singulair is "steriod-free," implying assurance from steroid ancillary effects. But parents are additionally told that Singulair, "is not a accomplishment medication. Always backpack your child's assigned accomplishment inhaler for emergencies or abrupt symptoms. If asthma affection get worse or your adolescent needs to access the use of fast-acting medicines, alarm the doctor at once."Why is a biologic that needs to be acclimated with a added biologic (like the LABAs Symbicort, Dulera, Advair Diskus) and that may accomplish asthma worse, a bestseller?
Parents are additionally told that kids on Singulair may experience, "hallucinations (seeing things that are not there), irritability, restlessness, sleepwalking, baleful thoughts and accomplishments (including suicide), trembling, and agitation sleeping." Hey, it may advice aqueous noses!
A bulk of Pharma-backed account accessories abutment Singulair kids' sales by adorning allergies into a above bloom problem. One commodity in Current Assessment in Internal Medicine warns that, "Patients with allergic rhinitis generally accept a bargain affection of activity (QOL) not abandoned due to the affection of allergic rhinitis (sneezing, nasal, pruritus, rhinorrhea, and congestion) but additionally because the pathophysiology of allergic rhinitis can agitate sleep," which causes, "fatigue, irritability, anamnesis deficits, daytime somnolence, and depression."
But some FDA biologic reviewers were doubter about Singulair's accomplishments in accouchement from the start. In the New England Account of Medicine, anon afterwards Singulair was approved, FDA reviewers cautioned that developed studies of the biologic "may not be predictive of the response," in children. In FDA new biologic approval abstracts in the backward 1990s, reviewers agenda that Singulair levels in adolescents are altered from "healthy adults," and that an baby monkey, four weeks old, had to be euthanized because "infants may be added acute to the toxicity," of Singulair. Three out of bristles guinea pigs additionally died from "severe anaphylactic responses." (If beastly tests do not extrapolate to animal safety, why are they done?)
In Singulair's new biologic approval documents, array of animal capacity are arise to accept aloof from trials because of "worsening" asthma and breath problems. There's an asthma biologic for you! Reviewers alike address that one study, "demonstrates that it is bigger to leave patients on beclomethasone [Qvar] than to about-face them to montelukast [Singulair]." Inhaled corticosteriods like Qvar, Flovent, Pulmicort and Asmanex were the accepted asthma analysis until drugs like Advair and Singulair were marketed.
Approval abstracts accommodate 10 blanked out pages, apparent "This area was bent NOT to be releasable," and the common phrase, "Portions of this analysis were excerpted anon from the sponsor's submission," as in we didn't apprehend it but we coiled it through.
William Busse, MD, who chaired the able console that wrote the government's 2007 National Asthma Education and Prevention Program Guidelines admitting his abounding Pharma banking links listed in the report, was additionally an investigator in the Singulair approval trials. He was issued an FDA admonishing letter aback an analysis of his ability arise incorrect accord forms, incorrect accommodating enrollments and biologic account and labeling errors, say Singulair's new biologic approval documents.
Meanwhile, added than 100 parents on the drug-rating web armpit askapatient.com address the affection the Merck/Scholastic sales allotment warns about: Singulair acquired hyperactivity, tantrums, depression, crying, academy trouble, facial tics, aberrant eye movements and self-harm in their children, some as adolescent as one. Abounding were put on the biologic for sniffles, asthmatic and aboriginal "symptoms" of asthma, in befitting with Pharma's "early treatment" push.
"Last night was a complete accident over every distinct affair that could accept possibly been a accessory annoyance, such as not actuality able to clasp abundant toothpaste out of the tube, which culminated in a 30-minute agreeable and arrant bonanza," writes the mother of a 7-year-old who has been on Singulair for six months. "I was account belief to her tonight, and she charge accept popped her jaw accessible at atomic 40 times over the advance of two books (mouth accessible advanced like a yawn in fast-forward). I was befitting an eye on her, and a few times I asked her why she kept accomplishing that and she said she didn't know, and she anticipation maybe her aperture was 'itchy.'"
"Do NOT acclaim this biologic to added parents," writes addition mother. "4 year olds that aback allocution about killing themselves are afflicted by a DRUG!!
In 2009, afterwards 15-year-old Cody Miller of Queensbury, NY was accustomed Singulair for hay agitation and took his own activity 17 canicule later, Singulair was accustomed a stronger admonishing for "neuropsychiatric" ancillary effects. And the abutting year, Fox TV arise that kids on Singulair are actuality diagnosed with ADHD, Tourette Syndrome and austere behavioral and acoustic conditions. Best are "cured" aback they go off the drug. Singulair is no agnosticism active added pediatric drugs sales.
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Even adults are put on Singulair for accessory affidavit with above consequences. "I was altogether advantageous above-mentioned to demography this drug," letters a 53-year-old woman about Singulair on askapatient. "Doc noticed I had a little buzz and assigned Singulair. I began to accept the dreams, indisposition and abasement afterwards the aboriginal few days," which led to "suicidal thoughts," she says.
Of course, drugs are not activated for a connected aeon of time afore they are marketed and abiding furnishings can and do arise later. But alike the concise assurance abstracts on which today's blockbuster asthma drugs were accustomed is beneath a acknowledged cloud.
One researcher, William H. Ziering, MD was bedevilled to six months in bastille and absent his medical authorization for adulteration of bristles biologic studies. Ziering conducted trials on salmeterol (the LABA), Flonase and added respiratory drugs and wrote medication-friendly affidavit like "Allergic rhinitis. Measures to ascendancy the misery," and "Diagnosis and analysis of allergic rhinitis and asthma in adolescence and childhood."
During the aforementioned time period, analytic trials of Singulair and at atomic bristles added top asthma drugs conducted at Vivra Asthma & Abhorrence were additionally advised by federal authorities. A "patient mill" was operated at the facility, amid in Tucson, to abridged the advantageous advantage paid for anniversary subject, whether or not participants were adapted , says Robert Davidson, MD, who served as sub-investigator on the trials.
The irregularities at the Vivra ability led to onsite FDA inspections in which assemblage told inspectors they were told to "NOT acknowledgment abeyant risks" to capacity to not "scare them away," and capacity were pressured to participate admitting risks to their heath. (One accountable was ailing from the trials.) Enrolling inappropriate capacity risks both their bloom and approaching users of the drug, whose assurance was "proved" from their participation.
In one study, conducted at Vivra and elsewhere, added than 40 percent of bodies on Singulair and salmeterol (the LABA in Advair) had adverse events, two withdrew with--anybody?-- "worsening asthma" and "one died as a aftereffect of bronchial asthma!" The drugs were "well tolerated," address the researchers.
There is no affirmation that approvals of drugs "tested" by Vivra or Ziering's operation were delayed or revoked nor do the accompanying arise affidavit arise retracted. At atomic one agent is said to accept formed at both facilities.
Among drugs activated at Vivra was the antibacterial Raxar, pulled from the bazaar for baleful affection accent abnormalities and the genetically engineered Xolair, which carries a astringent anaphylaxis admonishing and was advised by the FDA for affection advance and achievement links. Seventy-seven bodies who took Xolair had life-threatening allergic responses in a year and a half, according to FDA reports.
Genetically engineered drugs like Xolair amount as abundant as $20,000 a year and account TB, cancers and cool infections because they abolish the allowed system. But they assume slated to be the abutting big affair in asthma.
A abstraction in May says Xolair can provide, "additional analytic benefit" for patients who are "inadequately controlled" on inhaled corticosteroids. That's absolutely how Advair, Singulair and the added blockbuster asthma drugs were sold. The abstraction was adjourned by Xolair's architect and co-written by William Busse, who headed the government's National Asthma Education and Prevention Program Guidelines.
ENDS
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