WASHINGTON
WASHINGTON (Reuters) – The U.S. House of Representatives on Thursday approved legislation to temporarily avert looming pay cuts for doctors under the government’s Medicare health insurance program for older Americans and the disabled.
The measure was approved in a voice vote.
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Good news for members of congress and their staffs. There is a benefit to them that is not, astonishingly, available to ordinary citizens. As Pete Kasperowicz at the Hill reports, unlike millions of Americans, they:
… have a way to opt out of ObamaCare — retirement.
Until 2010, when the Physician Payments Sunshine Act passed, requiring doctors to disclose payments, the only thing better than working for Pharma was being a doctor wined and dined by Pharma.
Pfizer jetted 5,000 doctors to Caribbean resorts where they enjoyed massages, golf and $ 2,000 honoraria charges to sell its painkiller Bextra (withdrawn from the market in 2005 for heart risks). GSK sent doctors to lavish resorts to promote Wellbutrin, the Justice Department charged. Johnson & Johnson bestowed trips, perks and honoraria on Texas Medicaid officials to get its drug Risperdal preferred on the formulary, a state lawsuit charged. Bristol-Myers Squibb enticed doctors to prescribe its drugs with access to the Los Angeles Lakers and luxury box suites for their games, California regulators say. In China GSK is charged with using a network of 700 middlemen and travel agencies to bribe doctors with cash and sexual favors, and Victory Pharma, an opioid drugs maker, was charged with treating doctors to strip shows. Nice.
Of course, Pharma reps did as well as the doctors. Thanks to their Barbie and Ken doll looks and the free samples, gifts and lunches they would bring medical staff, they would often waltz in to see the doctor before the sick and waiting patients. Some had their own lounges at medical offices. Since the 2010 sunshine law, part of the Affordable Care Act, went into effect in 2013, drug companies must display the doctors and groups they pay on their websites. That includes their payments to faux grassroots groups like Go Red For Women and the National Alliance on Mental Illness, or NAMI, which are widely seen as Pharma fronts. But will it make a difference? For years, doctors have also begun presentations with slides detailing their Pharma funding but it doesn"t seem to alter their credibility or audience cynicism.
When it comes to acknowledging the influence of gifts and money on behavior, doctors, like everyone else, suffer from self-delusion. Most say they believe it affects the other guy, not them, and many become offended at the idea that they are “for sale.”
“My prescribing never changes because once a month a drug rep brings in a tray of sandwiches,” Maria Carmen Wilson told the Tampa Bay Times. (Wilson was Eli Lilly"s number-two earner in Florida in 2009, the paper reports.) It"s tempting to ask such doctors that if the largesse doesn"t affect them, when was the last time they prescribed the competitor"s pill? Would anyone believe or even read the journalism of a reporter who accepted an honorarium or speaker"s fee from the subject she reported on? Even if she claimed it didn"t influence her?
Trips to resorts and strip clubs will likely continue to diminish under the Physician Payments Sunshine Act, but there are many other ways, often sneaky, that Pharma can entice doctors to prescribe its expensive, patent drugs.
1. Spying on Prescribing
Like the NSA spying program, shameless spying on doctors" prescribing habits spares almost no one. Recently, the full sweep of IMS Health Holdings" prescription data mining was revealed by ProPublica, which reported that its collection includes over 85 percent of the world"s prescriptions and “comprehensive, anonymous medical records for 400 million patients.” In 2007, there was a backlash against another seller of medical information: the AMA itself. By selling the names, office addresses and practice types of almost every doctor in the US to marketing firms the AMA netted almost $ 50 million a year, the American Medical Student Association and the National Physicians Alliance charged at the AMA"s convention. The database of 900,000 doctors does not violate privacy, counters the AMA, since doctors can opt out.
Psychiatrist Dan Carlat wrote in the New York Times that he was “astonished at the level of detail that drug companies were able to acquire about doctors’ prescribing habits” and that his drug reps told him “they received printouts tracking local doctors’ prescriptions every week.” A 2011 Supreme Court ruling found the collection and dissemination of prescribing behavior was “speech” and protected by the First Amendment. (See: a corporation is a person.)
2. Continuing Medical Education Courses
In order to keep their state licenses and satisfy insurance regulations, doctors must enroll in a certain amount of CMEs—continuing medical education courses. Not surprisingly, these classes are often “taught” for free by Pharma-funded specialists, sparing doctors from having to pay for them but providing the objectivity of a time-share presentation.
One such class, “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough,” funded by Seroquel maker AstraZeneca was taught by former Emory University psychiatrist Charles Nemeroff, who lost his department chairmanship due to unreported Pharma income. Another CME called “Bipolar Disorder: Individualizing Treatment to Improve Patient Outcomes,” was “taught” by Trisha Suppes, who admits to funding by Abbott, AstraZeneca; GlaxoSmithKline, Janssen, Novartis, Pfizer, Wyeth, Bristol-Myers Squibb, Eli Lilly, Shire and four more Pharma companies. Another CME, “Individualizing ADHD Pharmacotherapy with Disruptive Behavioral Disorders” was taught by the Johnson & Johnson-funded Robert L. Findling and refers to Risperdal or its generic version, risperdone, 13 times. Many CMEs teach doctors about the lucrative new disease category of Adult ADHD and how to keep kids from going off their ADHD meds when they get to college. Ka-ching.
3. Ghostwriting
Being published in medical journals is essential to academic doctors but researching, writing and reworking papers is a formidable job. Luckily for doctors, Pharma is willing to help—as long as they write what Pharma wants. In just three years, medical writers associated with Parke-Davis, which became Pfizer, wrote 13 papers extolling the benefits of Neurontin, including in the prestigious Cleveland Clinic Journal of Medicine, in the names of the “author” doctors. Medical writers at Wyeth, also now Pfizer, wrote more than 50 papers pushing the now discredited Hormone Replacement Therapy (HRT) in the names of doctor “authors.”
“Is There an Association Between Hormone Replacement Therapy and Breast Cancer?” asked one article in the Journal of Women"s Health. Guess what it concludes? “The Role of Hormone Replacement Therapy in the Prevention of Postmenopausal Heart Disease,” another ghostwritten paper is titled, despite HRT"s established heart risks, appearing in the Archives of Internal Medicine. And despite HRT"s links to dementia, another paper, which also ran in the Archives of Internal Medicine, was titled “The Role of Hormone Therapy in the Prevention of Alzheimer"s disease.”
4. Speakers Bureaus
Few things combine the ego stroking and fast cash of being paid to speak—and Pharma has no trouble finding takers at $ 750, $ 1000 and more per pop. Psychiatrist Dan Carlat wrote in theNew York Times that his experience speaking about Wyeth"s Effexor degenerated as he sensed skepticism and contempt in the audience. “I feared I had become—a drug rep with an M.D.” A district manager soon expressed reservations (“My reps told me that you weren’t as enthusiastic about our product at your last talk”) and Carlat ended his speaking career.
In her book, The Truth About Statins, cardiologist Barbara Roberts echoes Carlat"s experience. She agreed to speak about Pfizer"s Lipitor and gender-specific aspects of heart disease in women, but told Pfizer “that I wasn’t interested in just getting up in front of a bunch of doctors and plugging one or another of Pfizer"s medicines.” Declining to use Pfizer-supplied slides, she created her own slides for the speeches “until one night a regional manager attended one of my talks—and suddenly I was no longer invited by Pfizer to give lectures.”
Carlat and Roberts are in the minority. Despite academic restrictions, faculty at many top institutions including division chiefs “stay on the industry lecture circuit, where they can net tens of thousands in additional income,” reported ProPublica in 2010. Even at the prestigious Cleveland Clinic where the chairman of cardiovascular medicine, Steven E. Nissen, calls industry-paid speakers “whores,” the practice flourishes, ProPublica reported.
5. Clinical Trials
Pharma-funded clinical trials can be paydirt to doctors, yielding as much as $ 10,000 per patient in some cases. In 2010, Sen. Charles Grassley (R-Iowa) addressed the frequent conflict of interest of doctors accepting major Pharma revenue while also accepting NIH money, our tax dollars. The medical institutions where the doctors work also are swimming in Pharma money. It is a situation exacerbated by the “technology-transferring” Bayh-Dole Act of 1980 which dangled the riches of “industry” before medical institutions just as the former were floundering and the latter was booming, says Marcia Angell, former editor-in-chief of the New England Journal of Medicine. ”Harvard’s Clinical Research Institute (HCRI), for example, originally advertised itself as led by people whose "experience gives HCRI an intimate understanding of industry’s needs, and knowledge of how best to meet them,"” writes Angell, “as though meeting industry’s needs is a legitimate purpose of an academic institution.”
Not all clinical trials are kosher. Another sneaky way Pharma gets doctors to prescribe its drugs is to set up faux clinical trials to influence doctors. A 1995 study billed as assessing the safety, efficacy and tolerability of Neurontin was nothing but a ruse to get the 772 participating doctors to prescribe the drug, said an article in the Archives of Internal Medicine, because it gave them familiarity and experience with the drug. (This indirect sales job parallels what is said to happen with speaker"s bureaus: the speakers may not convince anyone else, but they begin prescribing the drug themselves.) In addition to misleading the doctors who thought the trials were valid, the study also misled the patients who did not know it was a marketing, or “seeding” study, and whose participation was overseen by investigators with insufficient training and clinical experience. Eleven of the 2,759 patients in the trials died, 73 suffered severe adverse events and 997 experienced less serious side-effects.
More than 10 million people tuned in to see the special 50th anniversary episode of Doctor Who in the UK, according to overnight viewing figures.
At its peak, the show was watched by 10.61 million viewers, with an average of 10.2 million across the 75-minute running time.
It comfortably beat X Factor on ITV, which was seen by 7.7 million people.
But Strictly Come Dancing was Saturday night’s most popular show, peaking at 11.7 million viewers (10.6m average).
‘Beautiful reinvention’
The Day of the Doctor was broadcast in 94 countries at the same time as it aired on BBC One on Saturday night – earning it a Guinness World Record as “the world’s largest ever simulcast of a TV drama”.
Featuring three Doctors – Matt Smith, David Tennant and John Hurt – it delved deep into the character’s psyche over 75 minutes.
Amid the special effects and multiple time zones, critics were particularly impressed with the interplay between the actors.
The Telegraph’s Ben Lawrence wrote: “Tennant is edgy and mercurial, likely to turn on a pin. Smith is gentler, with a boyish eccentricity and other-worldly strangeness. They sparred terrifically with a fair amount of trademark humour.
“Smith’s Doctor teased Tennant’s about his ‘sand shoes’ and his weight. ‘Ooh. That is proper skinny. Hello matchstick man!’
“And yet they were both skilled enough to convince the viewer that they were one and the same person, both sharing a compassion, an acute intelligence and a formidable nose for danger.”
In a five star review, the Mirror’s Jon Cooper singled out writer Steven Moffat as the real star.
“He’s put something together here that not only gives hardcore fans a beautiful reinvention of their favourite show but also gives casual viewers a stonking story and a reminder why we all love this show so much,” he wrote.
“This had labour of love stamped throughout it,” agreed Simon Brew on the Den Of Geek website.
“It felt like a real treat, a gift to Who fandom, but more importantly, a strong episode in its own right.”
Opening with the show’s original credit sequence from 1963, the special featured the Daleks and the return of rubber suited, shape-shifting aliens the Zygons, who first appeared in 1975.
But the principal villain was potentially the Doctor himself.
The last few minutes affected me quite deeply”
End Quote
Neil Perryman, Doctor Who fan
Moffat’s story played with the idea, introduced when the science-fiction show re-launched in 2005, that the Doctor was the “last of the Time Lords”.
It transpired that Hurt’s version of the Doctor had committed mass genocide in order to halt a “Great Time War” – and the 75-minute episode saw him fighting to come to terms with that decision, aided by two future versions of himself.
There were also cameos from former star Tom Baker, and Peter Capaldi, who replaces Smith later this year.
“The last few minutes affected me quite deeply,” wrote Neil Perryman on the Guardian’s website.
He conceded that some of the details “didn’t make a lot of sense on first viewing” but added: “I don’t care – I’ll be watching it again this evening”.
Speaking immediately after the broadcast, star Matt Smith said: “I think what’s really clever about it is that what he [Moffat] has managed to do is change the mythology of the character – which, after 50 years, is an achievement.”
Aside from the emotional drama, the episode was filled with comedic moments – including a proposal, a marriage and “a machine that goes ding”.
“Is there a lot of this in the future?” John Hurt asked as David Tennant kissed Queen Elizabeth I.
“There is a bit, yes,” deadpanned Matt Smith.
The UK viewing figures are the science fiction programme’s highest since the 2010 Christmas Special.
They do not take into account people who taped the show, or watched it later on iPlayer – and are therefore likely to rise once consolidated figures become available.
Accepting the show’s Guinness World Record, Moffat said: “For years the Doctor has been stopping everyone else from conquering the world. Now, just to show off, he’s gone and done it himself!”
Tim Davie, from BBC Worldwide, said: “We knew we were attempting something unprecedented in broadcast history, not only because Doctor Who is a drama, unlike a live feed event such as a World Cup football match or a royal wedding, but because we had to deliver the episode in advance to the four corners of the world so that it could be dubbed and subtitled into 15 different languages.
“If there was any doubt that Doctor Who is one of the world’s biggest TV shows, this award should put that argument to rest”.
The global broadcast included 3D screenings in more than 1,500 cinemas in 94 countries – from Russia to Ethiopia.
They attracted hundreds of fans in fancy dress, including bow ties, fezzes and Dalek outfits.
A gala event at the BFI in London was attended by Smith, Hurt, Moffat and their co-star Jenna Coleman.
They received a huge cheer as the end credits rolled, while Tom Baker’s surprise cameo also received a large round of applause.
Photo by Alexander Raths/Shutterstock
Listen to Episode No. 6 of The Checkup: Talking Back to Your Doctor
The Checkup is a new health podcast, a collaboration between Slate and WBUR, Boston’s NPR News Station. You’ll find all six episodes on The Checkup’s individual feed.
Welcome to The Checkup. Our sixth episode, “Talking Back to Your Doctor,” opens with a question: Why do so many of us find it so hellishly hard to speak freely with our doctors? What is it about a white coat that makes even normally assertive people clam up?
We begin with the dramatic story of Alicair Peltonen, an administrative assistant diagnosed with a rare cancer who had to have a chunk the size of a baseball removed from her thigh. Throughout her medical saga, she found that she often had urgent questions echoing in her mind, but felt too inhibited to voice them. She set out to discover why. We speak with Dr. Jo Shapiro of Brigham and Women’s Hospital in Boston about what she calls “Conversation Deficit Disorder” among doctors. And we hear from Dr. Annie Brewster, who has special insight into doctor-patient communication because she’s both a practicing doctor and a multiple sclerosis patient who decided not to follow her doctor’s recommendations about taking a particular medication.
Your hosts are Carey Goldberg and Rachel Zimmerman, former newspaper reporters and co-producers of WBUR’s CommonHealth blog. Each episode of The Checkup features a different topic—previous topics included college mental health, sex problems, the Insanity workout, and vaccine issues.
The Checkup Podcast is produced at WBUR by George Hicks.
Like CommonHealth on Facebook, and tell us and other listeners what you think of this week’s edition. Or drop a note to podcasts@slate.com.
Dr. Anthony Garcia, 40, is pictured in this photo released by the Omaha Police. Omaha Police Chief Todd Schmaderer said that Garcia was arrested Monday, July 15, 2013, in Illinois. Garcia has been linked to both the May 2013 Omaha slayings of 65-year-old Roger Brumback and 65-year-old Mary Brumback and the 2008 stabbing deaths of an 11-year-old Thomas Hunter and his family housekeeper, 57-year-old Shirlee Sherman. The slain Brumback and Hunter fired Garcia in 2001 when he was a pathology resident at Creighton Medical School. (AP Photo/Omaha Police)
Dr. Anthony Garcia, 40, is pictured in this photo released by the Omaha Police. Omaha Police Chief Todd Schmaderer said that Garcia was arrested Monday, July 15, 2013, in Illinois. Garcia has been linked to both the May 2013 Omaha slayings of 65-year-old Roger Brumback and 65-year-old Mary Brumback and the 2008 stabbing deaths of an 11-year-old Thomas Hunter and his family housekeeper, 57-year-old Shirlee Sherman. The slain Brumback and Hunter fired Garcia in 2001 when he was a pathology resident at Creighton Medical School. (AP Photo/Omaha Police)
Omaha Police Chief Todd Schmaderer speaks at a news conference at police headquarters in Omaha, Neb., Monday, July 15, 2013. Chief Schmaderer said 40-year-old Dr. Anthony Garcia was arrested Monday, July 15, 2013, in Illinois. Garcia has been linked to both the May 2013 Omaha slayings of 65-year-old Roger Brumback and 65-year-old Mary Brumback and the 2008 stabbing deaths of an 11-year-old Thomas Hunter and his family housekeeper, 57-year-old Shirlee Sherman. Schmaderer says Brumback and Hunter fired Garcia in 2001 when he was a pathology resident at Creighton Medical School for erratic behavior. (AP Photo/Nati Harnik)
40-year-old Dr. Anthony Garcia is pictured in this photo released by the Omaha Police. Omaha Police Chief Todd Schmaderer said that Garcia was arrested Monday, July 15, 2013, in Illinois. Garcia has been linked to both the May 2013 Omaha slayings of 65-year-old Roger Brumback and 65-year-old Mary Brumback and the 2008 stabbing deaths of an 11-year-old Thomas Hunter and his family housekeeper, 57-year-old Shirlee Sherman. The slain Brumback and Hunter fired Garcia in 2001 when he was a pathology resident at Creighton Medical School. (AP Photo/Omaha Police Department)
Omaha Police Chief Todd Schmaderer walks past a photo of Anthony Garcia after speaking at a news conference at police headquarters in Omaha, Neb., Monday, July 15, 2013. Chief Schmaderer said 40-year-old Dr. Anthony Garcia was arrested Monday in Illinois. Garcia has been linked to both the May 2013 Omaha slayings of 65-year-old Roger Brumback and 65-year-old Mary Brumback and the 2008 stabbing deaths of an 11-year-old Thomas Hunter and his family housekeeper, 57-year-old Shirlee Sherman. Schmaderer says Brumback and Hunter fired Garcia in 2001 when he was a pathology resident at Creighton Medical School for erratic behavior. (AP Photo/Nati Harnik)
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OMAHA, Neb. (AP) — Authorities arrested an Indiana doctor Monday on suspicion of carrying out two attacks in Omaha over the past five years in which four people were killed who had ties to a local university medical school that fired him in 2001.
Dr. Anthony Garcia, who now lives in Terre Haute, Ind., was arrested by Illinois State Police during a traffic stop Monday in Union County, which is in the south of the state near Illinois’ borders with Indiana and Missouri, Omaha Police Chief Todd Schmaderer said. Officers said he appeared to be intoxicated when they arrested him that he had a .45-caliber handgun with him.
Garcia, 40, was being held in Illinois on suspicion of four counts of first-degree murder and four counts of using a weapon to commit a felony, Schmaderer said. An Illinois State Police official declined to discuss details of Garcia’s arrest or detention, and said any questions should go to Omaha police.
Garcia didn’t have a listed phone number in Terre Haute or in Chicago, where he previously lived, and it wasn’t immediately clear if he had an attorney. No one answered the phone at his family’s home in Walnut, Calif., Monday evening.
Public records show that since 2003, Garcia has held medical licenses in California, Illinois and Indiana, but his temporary Indiana license expired in January.
Investigators believe that in May, Garcia broke into the Omaha home of Creighton University medical school pathology professor Roger Brumback and fatally shot him and stabbed his wife Mary to death, Schmaderer said. They also believe Garcia was behind a 2008 home invasion in which the 11-year-old son and family housekeeper of another pathology department professor, William Hunter, were stabbed to death.
In 2001, Roger Brumback and Hunter fired Garcia, who was a department resident, because he had displayed erratic behavior, Schmaderer said. The police chief didn’t provide further details of the alleged behavior and he declined to discuss the evidence used to build the case against Garcia.
A task force of local, state and FBI investigators has been working on the case, and its members believe Garcia fits all the criteria of a serial killer, Schmaderer said.
“We didn’t feel this individual would stop unless an arrest was made,” he said.
Schmaderer said investigators believe Garcia acted alone, and that they are also searching several places where Garcia has lived since 2001.
The Omaha attacks happened in neighborhoods where homicides are rare. The city averages about 40 per year.
One of the Brumbacks’ three children, Darryl, said the family had no comment about the arrest. A male relative of Sherman’s also declined to speak. The Hunter family didn’t respond to a phone message seeking comment.
Hunter’s son, Thomas Hunter, and housekeeper, Shirlee Sherman, were killed at the family’s 3,700-square-foot home in the historic neighborhood of Dundee, which is home to some of the city’s most prominent residents, including billionaire investor Warren Buffet. The case was featured last year on an episode of “America’s Most Wanted,” and a $ 54,000 reward was offered.
Schmaderer said Monday that investigators don’t believe the boy and the housekeeper were the intended targets of the attack.
Authorities have released few details about the attack on the Brumbacks, other than manner in which they were killed. Their bodies were discovered in their west Omaha home on May 14.
The task force was set up after the Brumbacks’ deaths to investigate whether they were tied to the unsolved 2008 killings. Schmaderer declined to say what led investigators to Garcia.
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Associated Press writer Grant Schulte contributed to this report from Lincoln.
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Follow Josh Funk on Twitter at http://twitter.com/funkwrite
For the last 33 years, David Healy, an Irish psychiatrist and professor at Cardiff University School of Medicine in Wales, has written heavily researched university press books and academic journal articles on various aspects of psychopharmaceuticals. His output includes 20 books, 150 peer-reviewed papers and 200 other published works. He is not only well-pedigreed, with degrees and fellowships from Dublin, Galway and Cambridge medical schools, he is a widely recognized expert in both the history and the science of neurochemistry and psychopharmacology.
Yet Healy says his output and reputation have had little to no effect—both on the pharmaceutical industry he argues buries relevant information about prescription drug harms, and on the psychiatric and medical professions he claims are being “eclipsed” by drug companies.
“It’s been clear to me that writing books or articles banging on the risks and hazards of drugs is just going to increase the sale of drugs,” said Healy, who speaks calmly, dresses mostly in black and looks a bit like Rod Serling.
Rather than write another university publication, Healy has taken his frustration to the street. In November, he launched a nonprofit website called Rxisk.org with a group of like-minded and highly credentialed international colleagues. The site aggregates FDA data about prescription drug side effects and urges patients to submit a detailed report on their own pharmaceutical drug reactions.
Healy is not the first psychiatrist to express boiling frustration with the pharmaceutical industry or to pen dire warnings about drug-based healthcare. He is joined by people like American psychiatrist Peter Breggin, who has written several books critical of “biological psychiatry,” and Irving Kirsch, who directs the Program in Placebo Studies at Harvard Medical School/Beth Israel Deaconess Medical School and is best known for The Emperor’s New Drugs: Exploding the Antidepressant Myth. Healy is the author of such dire sounding titles as Pharmageddon and Let Them Eat Prozac: The Unhealthy Relationship Between the Pharmaceutical Industry and Depression.
For years, it was fairly easy for people in the pharmaceutical and medical industries to label Healy, Kirsch and Breggin as alarmists. But two summers ago, one of the most prominent members of U.S. medical establishment, Marcia Angell, former editor-in-chief of New England Journal of Medicine, published an article damning the over-prescription of psychoactive drugs. In two essays in the June 23, 2011 and July 14, 2011 New York Review of Books, Angell backed arguments by the university clinician Kirsh, the mental heath journalist Robert Whitaker, and Boston psychiatrist Daniel Carlat that there is something extremely suspicious about the following trends: the number of people treated for depression has tripled since the launch of Prozac in 1987; 10 percent of Americans over age six are taking antidepressants; and 30 antipsychotics like Risperdal, Zyprexa and Seroquel are replacing cholesterol-lowering agents as the top-selling class of drugs in the U.S., largely because they are being prescribed to children.
Angell’s articles should have been a bomb on the medical establishment. She wrote:
“The industry-sponsored studies usually cited to support psychoactive drugs—and they are the ones that are selectively published—tend to be short-term, designed to favor the drug, and show benefits so small that they are unlikely to outweigh the long-term harms. … Both the pharmaceutical industry and the psychiatry profession have strong financial interests in convincing the public that drug treatment is safe and the most effective treatment for mental illnesses, and they also have an interest in expanding the definitions of mental illness.”
But like Healy, Angell’s warnings have fallen on deaf ears. Recent data indicates that U.S. prescription drug use is growing. The September 2012 Consumer Reports National Research Center report found that among the 46 percent of American adults taking prescription drugs, a fourth of those ages 18 to 39 regularly take two prescription drugs, indicating that multiple drug use is no longer confined to older Americans. Congressional testimony in 2012 by the American Society of Interventional Pain Physicians revealed that Americans consume 80 percent of opiate painkillers produced in the world. And a January 2011 report from Stanford University Medical School warned that antispychotics are now regularly being prescribed to treat conditions for which they have not been approved, including anxiety, attention-deficit disorder, sleep difficulties, behavioral problems in toddlers and dementia.
According to a Feb. 7, 2013 report from Drugs.com, the No. 1 best-selling U.S. drug (in dollar volume) is an atypical antipsychotic for schizophrenia treatment called Abilify. Sales for the last quarter of 2012 soared to $ 1.5 billion, because Abilify is widely prescribed off-label—i.e., not for schizophrenia in adults, but, for example, for irritability in children. Although Bristol-Myers Squibb, the maker of Abilify, was fined $ 515 million in September 2007 for recommending off-label uses of Abilify, doctors are still doling out the drug. Why?
“The reason for the increase in prescription drug use is that the entire Western medical complex is run by pharmaceutical companies,” said a Stanford University professor of medicine who preferred to remain anonymous (and who was not involved in the 2011 report on antipsychotics). “The medical training you get in Western medical schools is largely about learning which drugs to treat which diseases.” She added: “You would think that recent studies, such as the one that said antidepressants are no more helpful than a placebo, would have an effect. But they haven’t.”
Other university psychiatrists and medical doctors I contacted for this article either wouldn’t talk on the record or didn’t want to be interviewed, confirming an atmosphere Healy describes as “McCarthyist.” “There is a climate of fear,” he said during our interview. “You find that they are very nervous about saying anything about drug treatments or adverse effects of drugs at all. Doctors keep patients on lots of drugs, even if they are uncomfortable with it. And if you ask them why they’re doing so, the answer you’ll get is: ‘Well, this is the standard of care, and if I don’t take care of it this way, I’m going to be in awful trouble.’”
This standard of care is why Rxisk is directed at patients, not doctors, whose financial ties to the pharmaceutical industry are well documented. Rxisk allows users to enter into its search engine the name of a prescription drug and to see the side effects that have been reported to the FDA’s MedWatch website since 2004 as well as from Rxisk’s international data base, for more than 35,000 drug names from 103 countries, totaling 4.5 million adverse drug event reports. The site has information “zones for sex, violence, hair, skin, and withdrawal, designed to increase awareness of seldom-publicized drug effects. Rxisk.org also allows users to add their own reports of adverse drug reactions, creating their own “Rxisk report” to share with their doctor or pharmacist. Since November 2012, the website has collected 1,500 reports.
One could argue that Rxisk is doing the same thing as MedWatch, the FDA’s online gateway for “reporting serious problems with human medical products.” But Kalman Applbaum, a Rxisk founder and professor of medical anthropology and global studies at the University of Wisconsin, argues that MedWatch isn’t for patients—especially those “trying to sort out whether it’s the drug or the illness that’s causing the suffering.”
“We felt there were a number of things that were lacking on most or all of the FDA sites that collect information about drug side-effects,” said Applbaum. “First, there’s a reliance on doctor reporting, and doctors report very little, very infrequently—and this is true all over the world for a variety of reasons. And what they report is extremely slim. Very common is a single word to describe a side effect, such as hypertension, ataxia, etc.” Meanwhile, said Applbaum, research shows that patients are much more motivated to report than doctors. And more importantly, “their reported data is very high quality data, because they spend a lot of time,” said Applbaum.
Since the November 2012 launch, Rxisk has received only 10,000 visitors per month. But Healy, Applbaum and the other founders, like Nancy Olivieri, a senior scientist at Toronto General Hospital and University of Toronto Professor of Pediatrics, Medicine, and Public Health Sciences, are not particularly concerned and plan to ramp up and market their efforts slowly. “We’re doing something that’s new and it’s probably going to take awhile for people to cotton on to what’s new about it,” said Healy.
**
David Healy does not consider himself a radical. He prescribes antidepressants and other prescription drugs to his patients. He runs a national university school of psychological medicine. “I’m fairly conservative. I’m a very mainstream doctor, really,” he said. But as New York Times reporter Benedict Carey pointed out in a 2005 story, the Irishman living on an island off the coast of Wales “has achieved a rare kind of scientific celebrity: he is internationally known as a scholar and pariah.”
Healy’s status as an outcast arises from his grave concern that blockbuster drugs like Prozac and other antidepressants can lead to suicide, murder and unforeseen mental health problems. In the 1990s, he began to publish academic journal papers providing evidence that antidepressants could increase the risk of suicide. Although many colleagues denied the link, by 2004 American and British drug regulators issued strong warnings supporting Healy’s and other’s claims.
This was vindication for Healy. But it did not prevent him from losing in 2001 a job offer to direct the Center for Addiction and Mental Health in the University of Toronto’s Department of Psychiatry. There is an entire website devoted to Healy’s travail, what’s known as the “Toronto Affair.” The assembled documents—a lecture by Healy, email exchanges, and Healy’s legal claim against the university (which he won out of court)—form a parable on the limits of academic freedom. They also show how radical Healy’s beliefs are when set against the standards of privately supported research universities.
In a brief, sweeping and somewhat rambling history of psychopharmacology, Healy hit a lot of fly balls. He said that drugs “have played or threaten to play a part in a changing of the social order.” He intimated that psychiatric drugs, unlike illegal drugs, are a form of institutional control. In the Nov. 30, 2000 lecture, titled “Psychopharmacology and the Government of the Self,” he also made the following statements:
What’s amazing about Healy’s lecture is that he thought he could deliver it and still work at a university psychiatry department. According to the UK Guardian, the Center for Addiction and Mental Health has received more than $ 1.5 million in recent years from Eli Lilly, the manufacturers of Prozac. On the other hand, nothing that Healy said in Toronto, he hadn’t said before.
In the most comprehensive news article on the Toronto Affair, the Guardian’s Sarah Boseley reported that Lilly and Healy had previously “crossed swords” in the U.S. courts: “Dr. Healy has been an expert witness against [Lilly], backing the claims of families who say the drugs have caused people to kill and commit suicide. In June 2001, just six months after his Toronto job was rescinded, a US jury agreed with him that Paxil (Seroxat in the UK), an SSRI manufactured by the British giant GlaxoSmithKline, caused Donald Schell to kill his wife, daughter, granddaughter and himself and awarded the remaining family members £4.2m compensation.”
More recently, Healy has tried to draw attention to the connection between the increasing use of antidepressants and antispychotics and the increasing number of school shootings. On a Jan. 30, 2013 blog and video on Rxisk.org, he claimed that 90 percent of school shooters in North America and Europe were on or withdrawing from meds at the time of the incident. In our interview he pointed to a list on SSIRStories.com, a patient anecdote website that is being integrated into Rxisk, that documents which perpetrators were on which drugs for violent acts in schools between 1988 and 2011.
The only semi-mainstream figure to have paid attention to this claim is filmmaker Michael Moore, who created a video on the subject in 2012, calling for an investigation. Unsurprisingly, there has been no move to look at the correlation, since one could argue that the school shooters are psychologically disturbed and should be on more meds. Indeed, across the country, there is a drive to keep a lookout for students with possible mental health problems and to report those who seem odd.
“The problem is,” says Healy, “that it’s really going to lead to a greater use of pills. The key thing is to make sure that people who get put on them are really going to be helped by them. Once you identify the problem, the pill will be the answer, because it’s the answer for the person who has identified the problem. It may not be the answer for the person who is having to take the pill.”
One of Healy’s main problems these days is that few people listen to him. “I published a list of 98 drugs that can cause you to commit suicide or homicide. I was waiting for the world to come to an end, but nothing happened.” He continued, “If I make a claim and I don’t have scientific proof to back it up, pharmaceuticals are going to sue me.” There have been no lawsuits, which makes Healy think that silence is part of pharmaceutical companies’ tactics. “They’ve learned that the worst thing they can do is argue. If they jump up and down and say, ‘Listen to the foolish things Healy is saying,’ that would be a good way to hear about Healy. So they’re very good at not responding, maintaining their cool.”
All of this sounds rather paranoid, but then again none of the dozen university psychiatrists or drug company scientists I reached out to wanted to talk about Healy or his claims. Neither Eli Lilly nor GlaxoSmithKline could “find time” to respond to my inquiries about Healy and Rxisk. I was permitted, however, to send questions by email to MedWatch, the website that culls adverse reactions to pharmaceuticals run by the FDA. Dr. Lisa Kubaska of the FDA’s press arm, CDER Trade Press, wrote, “Rxisk.org’s efforts to increase awareness of drug/medication associated risk, harm and best practices, along with their message about the value of voluntary reporting may also serve to advance this patient safety goal in parallel with FDA’s work.” But when I emailed her back, to ask how the FDA works with a pharmaceutical company if it gets multiple reports from patients or doctors about an adverse effect to a drug, I received no answer.
***
Among David Healy’s many concerns about the state of modern medicine is the marginalization of doctors. Doctors, he’s said, are like cogs in a machine, spending a minimum of time with patients, doling out drugs pushed by pharmaceutical companies, and wrangling with insurance companies over costs. He argues that one rectification to the sad state of his profession is to abandon “evidence-based medicine” for “data-based medicine.” The difference between the two goes to the root of why Healy founded Rxisk.org.
Evidence-based medicine categorizes different types of clinical evidence—such as randomized, triple-blind, and placebo-based control trials—and rates or grades them. Because evidence-based medicine relies on scientific methods that can have wide acceptance among medical practitioners, it has become the standard approach to health services and public health—and is one of the ways nations can arrive at universal healthcare systems.
But Healy and his colleagues at Rxisk argue that evidence-based medicine is flawed because important information ends up being systematically buried or corrupted. In his 2012 book Pharmageddon, Healy argues (and provides evidence) that close to 30 percent of the clinical drug trials that have been undertaken remain unreported; and of the 50 percent that have been reported, almost all are ghostwritten by scientists for pharmaceutical companies.
Perhaps more frighteningly, Healy reports that roughly 25 percent of published clinical drug trials are statistically altered, to provide evidence that a drug works well and is safe. And in 100 percent of the cases, the data from the trials remain inaccessible to scrutiny. Yet, he writes, 80 percent of the reports on adverse consequences of drug treatment, dismissed as anecdotes, have turned out to be correct. “Given these facts,” Healy writes, “it is not reasonable to suggest that the observations of doctors and patients are less reliable than clinical trial evidence.”
Healy’s push to abandon evidence-based medicine is not at attempt to get rid of randomized, triple-blind and placebo-based control trials, but to show the degree to which these trials are controlled by the pharmaceutical industry. So Rxisk’s preference for “data-based medicine” is simply a euphemism. It’s a push to expand evidence-based medicine to include full clinical trial transparency and to put anecdotes, specifically from patients, into the wider scientific analysis of drug efficacy.
It seems reasonable. But can it be done?
***
Tanya Jensen is a fairly typical middle-aged woman. She is 37 years old, has two little kids, and occasional bouts of mild depression. (To protect her identity, her name has been changed.) When her husband lost his job in 2008 and had trouble finding work, Tanya took on a full-time job with a long commute and a part-time job. Within a few months, she felt frazzled. She began to notice that some of her mom friends, who had their own reasons for feeling frazzled, were taking antidepressants, especially Celexa. So at a checkup with her general practitioner, she inquired whether she could try the drug. Her physician agreed and wrote her a prescription for the generic version of Celexa, citalopram, at 10 mg a day, the lowest dosage, asking Jensen to check in if anything went wrong.
Jensen liked the drug. It made her feel less anxious. But a year later, the Jensens’ situation improved and Tanya decided it was time to wean herself from the pills. Jensen said she worried “about being on the drug for the rest of her life, when it was unclear how it could affect her brain or behavior long-term.” As recommended by her physician, Jensen cut the dosage to 5 mg a day for 10 days and then to 5 mg a day every other day for the next 10 days. But at the end of the 20-day period, she had withdrawal symptoms: night sweats, emotional volatility, anger, aggression, suicidal impulses. Her husband begged her to go back on citalopram and she did.
A year passed, and Jensen decided she was ready to go off citalopram again. She proceeded with the same reduced dosage regimen and by the end of the 20-day period was, she said, “as close to manic as I hope I’ll ever come: full of rage, prone to tantrums, sweating buckets at night, and feeling suicidal, especially while driving.” Again her husband begged her to go back on citalopram and she did so.
That’s when Jensen started doing Internet research on citalopram and found Rxisk.org. There, she said, she found the best available information on citalopram and other people’s withdrawal symptoms, including a long list of adverse side-effects and the percentage of people who had reported them. When Jensen filled out a Rxisk Report, she received a 9+ score, indicating that she had become drug dependent. “This was alarming, but not really surprising,” she said.
Per RxISK’s recommendation, Jensen made an appointment with her doctor to discuss her problem. Jensen had switched health insurance providers, so she had a new general practitioner, a female MD with a degree from the University of Bombay, whom she chose, “hoping that she would be a less typical American doctor.” But Jensen was disappointed. The doctor said, “But you feel less anxious, and your dose is so low. When I fill out a prescription for 10 mg of citalopram, the computer prompts me to up the dose. It actually recommends I prescribe 20 mg, not 10 mg.” Jensen asked if she had other recourse, but her doctor waved off her concern. Before leaving the examination room, she handed Jensen a six-month prescription of citalopram. Jensen did get her doctor’s permission to review her Rxisk Report. But Jensen said that since emailing the report on May 10, 2013, she has heard nothing from her doctor.
“What upsets me most,” Jensen said, “is that my original doctor never told me about citalopram’s very well-documented withdrawal problems. This was just never part of the discussion, either because she didn’t have the time or didn’t know that stopping citalopram can be very tricky for some people. And what’s scary is that when I tried to communicate my problem with the second doctor, I was patted on the head like a child and handed 900 more pills.”
Healy is aware that changing doctor’s views on pharmaceuticals is a David and Goliath battle. That’s why he and his colleagues have another potential audience for Rxisk data: investors and insurance companies. “The shrewd investor in pharma companies wants to know what the adverse effects of a drug are,” said Healy. Rxisk is therefore positioning itself to provide data from the trials the companies are most keen to hide. In addition, Rxisk hopes to find clients in HMOs and insurance companies, which are looking for ways to cut drug costs.
“Many of drugs advertised are rigged to look better than previous generations of drugs and are costed sometimes 10, 20, 30, or 40 times higher than the generic drug,” Rxisk co-founder Applbaum said. “A bit of research through the data will show that the claims of improvement are false.”
Applbaum and Healy also point out that the cost of adverse side-effects to prescription drugs in the U.S. is huge—estimated to be $ 100 million in hospital costs alone. The same 1998 University of Toronto study they cite found that pharmaceuticals are the country’s fourth leading cause of death. Healy and Applbaum point to other galling statistics: the U.S. spends twice as much on healthcare as anyone else in the world, consuming a total of 45 percent of the world’s pharmaceuticals. Meanwhile, the World Health Organization ranks the country 37th in the quality of our care.
“So it’s killing the economy overall, and the recognition is seeping in that we’re doing something wrong,” said Applbaum. “We believe that our little piece of it—the over-prescription of drugs, the polypharmacy, the prescribing of drugs when none are needed—can help healthcare costs come down.”
Both Applbaum and Healy believe the FDA won’t or can’t be a force for change. Since the Drug Efficacy Amendments were passed in 1962, requiring drug manufacturers to prove to FDA the effectiveness of their products before marketing them, Healy says drug makers must show, first, that a drug works, and second, that it is safe. “The result has been that the effectiveness profile has taken over and safety has been lost sight of,” said Healy. “At Rxisk, we’re trying to restore safety to its due place.”
BEIRUT (AP) — At least 300 seriously wounded residents of an embattled Syrian town near the border with Lebanon need to be evacuated for medical treatment, a doctor told The Associated Press on Monday, as fighting in Qusair raged for the third straight week.
Kasem Alzein, who coordinates treatment in several makeshift hospitals in Qusair, said the wounded are being treated in private homes after the town’s main hospital was destroyed during fighting between the Syrian army — backed by Lebanese Hezbollah guerrillas — and rebels fighting to topple President Bashar Assad’s regime.
Speaking to the AP from Qusair via Skype, Alzein pleaded for help, saying evacuation efforts by local medical teams had failed after a convoy was attacked last week and 13 of the wounded were killed. He said medical supplies are running out and doctors treating the wounded most urgently need oxygen to keep the 300 people — mostly women, children and elderly — alive.
“The humanitarian and medical conditions are terrible,” Alzein said, adding that no medical supplies have reached the town since the government launched an offensive on Qusair May 19. “We are treating people in homes in an unsterilized environment. We tried to evacuate the wounded and we can’t. No one is helping us.”
Alzein said 50 abandoned homes around Qusair have been turned into makeshift hospitals. Four of the homes have been converted into operating theatres. He said the doctors had stocked up on medical supplies, but they are running out of antibiotics, bandages and anesthetics. Oxygen supplies are already exhausted, he added.
The shelling of the town continued Monday, Alzein said. “Every day we have new wounded.”
Appeals by the United Nations and other aid organizations to allow humanitarian workers to enter Qusair have gone unheeded by authorities in Damascus as fighting drags on and neither side has been able to deliver a decisive blow. Syrian regime troops and fighters from Hezbollah have gained ground, but rebels have been able to defend some positions and appear to be dug in the north and west of the town.
On Sunday, U.N. chief Ban Ki-moon called Syrian Foreign Minister Walid al-Moallem to express concern over the situation in Qusair, according to Syria’s state-run news agency SANA. However, al-Moallem told the U.N. chief that the Red Cross and other aid agencies will only be able to enter Qusair “after the end of military operations there,” SANA said.
The European Commissioner for International Cooperation, Humanitarian Aid and Crisis Response, Kristalina Georgieva, on Monday said she was joining the U.N and the Red Cross in appealing for a safe passage for civilians in the town, describing the situation in Qusair as a “tragedy.”
“All right-thinking people will join me in appealing for all parties to this savage conflict to respect the fundamental rights of civilians to safe passage,” she said in statement. “These appeals have been falling on deaf ears. In a moment like this we must together all raise our voices ever more loudly until our protests can no longer be ignored.”
Also on Monday, Hezbollah guerrillas fought Lebanese Sunni militants trying to reach Qusair to join the Syrian rebels. Residents said clashes were taking place in the Syrian village of Jousih, about 13 kilometers (eight miles) from Qusair. There were no immediate reports on casualties.
Over the weekend, three rockets from Syria struck Lebanon’s northeast and 18 rockets and mortar rounds hit its eastern Baalbek region, a Hezbollah stronghold.
From Saturday night into Sunday, Hezbollah fighters inside Lebanon ambushed Syrian rebels and allied Lebanese fighters whom they suspected of rocketing Baalbek, a Lebanese security official said. The clashes were the worst yet inside Lebanon, where the Syrian conflict has intensified since Hezbollah’s involvement in Qusair fighting has been public recent weeks.
A Hezbollah fighter and several rebels were killed in Monday’s clashes, which happened in a remote area near the Syrian border, said the official, who spoke on condition of anonymity in line with regulations.
Elsewhere in Lebanon, gunmen fired on a prominent pro-Hezbollah Sunni cleric in the port city of Sidon on Monday but failed to hit him, security officials said. The attack on Sheik Maher Hammoud increased fears that the Syrian conflict could re-ignite the country’s explosive sectarian mix that mirrors the one in Syria. Lebanon’s 15-year civil war ended in 1990.
Hammoud was fired on by assailants in a moving vehicle as he walked from his home to the al-Quds Mosque where he preaches, the officials said. His bodyguards returned fire but no one on either side was hurt, they said, speaking on condition of anonymity in line with regulations.
Hammoud is a longtime supporter of Hezbollah, whose power base lies in Lebanon’s Shiite Muslim community and which is supported by Iran. The group’s role in Syria’s civil war has become more apparent in recent weeks as the group buried dozens of fighters who have been in an ongoing battle for Qusair.
They fight on behalf of President Bashar Assad’s regime, dominated by his Alawite sect that is an offshoot of Shiite Islam.
Sidon is a majority Sunni Muslim city, and many Lebanese Sunnis back Syria’s Sunni-dominated rebels. It was not clear who was behind the shooting. Hammoud told Lebanon’s private Al-Mayadeen TV that he assumed it was linked to his support for “Hezbollah’s jihad” in Syria.
Rival sectarian factions have frequently clashed inside Lebanon during the 2-year-old Syrian conflict.
In the north, fighting between Sunnis and Alawites in the city of Tripoli raged overnight into the early hours of Monday. Security officials said five people have been killed and 34 wounded since Sunday. They spoke on condition of anonymity in line with regulations.
By daytime, fighting had largely subsided although snipers were still active in the most affected neighborhoods, Lebanon’s official news service said. The army was patrolling the city, and universities, schools and business had opened, it added.
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Associated Press writer Zeina Karam contributed to this report.
