By Alex Roslin November 19, 2009 The Georgia Straight [see the story at the Straight website] Chris Shaw wasn’t always skeptical about vaccines. The neuroscientist at the University of British Columbia had his teenage son vaccinated with most of the recommended shots. But then he started studying some of the ingredients commonly found in vaccines. What he discovered caused him to go cold turkey on all shots for his six-year-old daughter. And that includes the vaccine for the H1N1 flu. “I am not convinced H1N1 is sufficiently hazardous to most people to risk the potential downside of the vaccine,” Shaw said over the phone from his office in the research pavilion at the Vancouver Coastal Health Authority. Shaw isn’t an easily dismissed vaccine conspiracy theorist. He is a leading expert on amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) and Parkinson’s disease. While investigating unusually high rates of ALS and other neurological disorders among veterans who have Gulf War syndrome, he found evidence that the cause may have been aluminum salt, an ingredient in the cocktail of vaccines given to soldiers before deployment [see sidebar, below]. Although aluminum salt isn’t present in the H1N1 vaccine, Shaw’s discovery made him concerned about other vaccines, including the swine-flu shot. He isn’t alone in his thoughts. Despite a full frontal assault of news about the dangers of the flu and the importance of vaccination, a survey in late October revealed that only 36 percent of Canadians said they would get the shot. Lack of trust in the vaccine was cited as the main reason for vaccine opposition. Another poll in November found that 65 percent of Canadians believe the media has overreacted to the threat of swine flu. Even many health workers aren’t convinced. In two separate surveys, in the U.K. (Pulse) and Hong Kong (British Medical Journal), published in August, half of health-care professionals said they didn’t intend to get the vaccine. Canadian health officials and some newspaper columnists have reacted by accusing vaccine opponents of being conspiracy mongers or just plain irresponsible. Who is right? Is the cure really worse than the disease? Let’s look at some numbers. First, the disease. Swine flu had killed 161 Canadians as of November 12. That works out to one death per 200,000 Canadians in the past six-and-a-half months. Over the same period of time, major cardiovascular diseases typically claim 240 times more Canadian lives (about 39,000), cancer claims 230 times more (37,000 deaths), pneumonia kills 18 times more (2,800), and accidental falls claim eight times more (1,260), according to calculations based on 2005 Statistics Canada figures. H1N1 has about the same death rate as hernias. But we don’t see scary front-page headlines for months on end about hernias, pneumonia, or falling down. “It’s really not causing—and is not going to cause and nowhere has caused—significant levels of illness or death,” Dr. Richard Schabas, Ontario’s former chief medical officer of health, told the CBC on November 12. Schabas said H1N1 “has ultimately turned out to be, from a pandemic perspective, a dud”. What about the vaccine? Is it safe? Despite the onslaught of confident pronouncements from health officials and doctors, Shaw says he hasn’t seen enough information on the safety of the vaccine. “If the science were there, we could make a rational decision. But it’s a coin toss.” Looking for answers, Shaw turned to the 24-page product-information leaflet on the vaccine released by drug giant GlaxoSmithKline. Health Canada used this document in approving the shot. The leaflet leaves Shaw cold. “You couldn’t turn this in as a master’s thesis anywhere I know of and get a passing grade,” he said, calling the leaflet a “shocking document”. Shaw said the material lacks basic information. For example, there is no safety data at all for several groups of people—pregnant women, people aged over 60, kids aged 10 to 17, and children under three. For kids three to nine years old, there is only “very limited” data. “Where is the safety data that the government used to license the vaccine?” Shaw asked. Health Canada would not talk to the Straight, and the Public Health Agency of Canada did not respond to a request for an interview. The H1N1 vaccine includes a component called an adjuvant—which is used to boost the drug’s effectiveness—that has raised a lot of questions. GlaxoSmithKline says the adjuvant has been tested on 45,000 people worldwide and that clinical trials are now being done on children. In an e-mail, spokesperson Melanie Spoore said the company is planning 25 trials of its various H1N1 vaccines before November 2010. She also said a different but closely related vaccine made by the company, for the H5N1 flu, includes the same adjuvant and “is generally well-tolerated and has an acceptable safety profile” in both kids and adults. But Shaw has concerns about the company’s trial results for the H5N1 vaccine. The product leaflet mentions a study in which the company injected the vaccine into pregnant rats. It found “an increased incidence of fetal malformations” and “delayed neurobehavioural maturation”. Another study did not produce the same outcome. But Shaw says the rat results deserve more study. “Anytime you observe such outcomes, it is a concern,” he said. The leaflet also mentions a study on ferrets. The animals were given adjuvanted and nonadjuvanted H5N1 vaccines and then exposed to the flu. The ferrets that got the adjuvanted vaccine were protected by the vaccine. But those that got the nonadjuvanted vaccine all died. This result could be a concern, Shaw said, because Canadian authorities are telling pregnant women to get the nonadjuvanted H1N1 vaccine since the adjuvanted version hasn’t ever been tested on pregnant women. Shaw also said the animal-study information in the leaflet lacks many important details and would be “unpublishable” as presented. “Any [medical-journal] referee would kick this out the window.” The company’s leaflet also paints a picture of the vaccine’s side effects in humans somewhat different than the usual line from health authorities. The Public Health Agency of Canada says on its Web site that the adjuvanted vaccine is as safe as the nonadjuvanted shot. It also says the rate of “serious adverse events” from vaccination is extremely low—typically “about one for every 100,000 doses of vaccine”. What we don’t often hear is that the adjuvanted vaccine caused dramatically more side effects than the nonadjuvanted version. Ninety percent of 62 subjects reported pain (versus 37 percent of 62 people for the nonadjuvanted vaccine), 34 percent had muscle soreness (compared to 8 percent with the nonadjuvanted shot), and 14 percent experienced a headache (as opposed to 8 percent for the nonadjuvanted shot), according to the product-information sheet. Although these reactions are minor, the leaflet also says four of 253 people studied experienced “severe adverse reactions”. Three of the four were deemed to be unrelated to the vaccine, but one case of hypersensitivity (which can mean anything from an allergic reaction to autoimmune disease) was determined “to be related to vaccination”. That one serious reaction might not sound like a lot, but it actually translates into a rate of 395 cases per 100,000 people. That’s more than 50 times the rate of hospitalization due to H1N1 itself: 7.3 per 100,000 Canadians. Sucharit Bhakdi is concerned some serious vaccine reactions could go unnoticed. He is a professor of medical microbiology at the Johannes Gutenberg University of Mainz in Germany. In October—in a coauthored paper in the journal Medical Microbiology—he warned of a possible increase in the risk in heart problems due to mass H1N1 vaccination. Speaking by phone from his office, Bhakdi cited the higher rate of heart problems when 1.4 million U.S. soldiers were vaccinated for smallpox before the 2003 Iraq war. Soldiers who received the vaccine had almost 7.5 times the rate of heart inflammation of nonvaccinated personnel, according to a study by U.S. military medical researchers in 2004 in the American Journal of Epidemiology. “Unexpected serious adverse effects thus may follow in the wake of a general vaccination program,” Bhakdi’s paper said. Yet health authorities and doctors are urging people with heart problems to get the H1N1 vaccine on a priority basis and do not appear to be monitoring them for possibly elevated risks, he said. Shaw is also concerned about Canada’s monitoring of the side effects of vaccinations, calling the system “flimsy”. What especially worries Shaw is the possibility of longer-term side effects from the vaccine. Most vaccine safety studies monitor patients for a few days or, at most, several months. That isn’t enough, Shaw says. With some vaccines, the most serious reactions have taken years to surface. “Neurological problems don’t happen overnight,” he said. “It took five to 10 years to see the bulk of the Gulf War–syndrome outcomes.” One of the best examples involves a controversial ingredient present in the H1N1 vaccine: thimerosal. Thimerosal is a form of mercury used in some vaccines as a preservative. Drug makers agreed to phase it out of most vaccines after the U.S. Food and Drug Administration found in 1999 that mercury levels in children who had gotten multiple shots often exceeded safety levels set by the Environmental Protection Agency (EPA). Nonetheless, thimerosal still remains in many flu vaccines. Controversy has raged for years about whether or not thimerosal is behind soaring childhood autism rates. While that debate continues, a 2008 study in the U.K. journal Toxicological and Environmental Chemistry found that boys who were given a vaccine containing thimerosal were nine times more likely to have developmental problems than unvaccinated boys. The Public Health Agency of Canada says on its Web site that thimerosal is safe and that the amount in the H1N1 vaccine is below Health Canada’s daily safety limit set for mercury. “There’s significantly less mercury in the vaccine than you would find in a can of tuna fish,” the site states. In fact, the amount of mercury in the nonadjuvanted H1N1 vaccine does actually exceed the daily safety level for pregnant women. Health Canada has established the safe dietary level of mercury for pregnant women at 0.2 micrograms (millionths of a gram) per kilo of body weight. The nonadjuvanted H1N1 vaccine contains 25 micrograms of mercury. Simple math tells us an average Canadian pregnant woman—weighing 80 kilograms at term—gets about 56 percent more than the daily safe level of mercury when given a dose of the nonadjuvanted vaccine. By the EPA’s stricter standards, that same dose is actually triple its daily safe level. What’s more, Shaw notes, those daily safety levels were set for consumption of mercury in food, not for injection directly into the body. Injecting a neurotoxin like mercury has much more impact than eating it, he said. Squalene is another controversial component of the swine-flu vaccine. It’s an oil found in animal livers and is used as an adjuvant in vaccines and also as a moisturizer in cosmetic products. It is primarily gotten from shark livers—a fact that has upset conservation groups worried about endangered shark populations. Some companies, like Unilever and L’Oréal, have agreed to stop using squalene in cosmetic products. Debate has raged for years about whether or not squalene is responsible for Gulf War syndrome. Most research suggests that’s not the case, but in recent years much more solid evidence [see here, here, here and here] has found squalene can cause autoimmune diseases like lupus and rheumatoid arthritis in animals. Still other questions have been raised about polysorbate 80, another component of the H1N1 vaccine adjuvant. Studies have found it can cause severe allergic reactions and hypersensitivity [see here, here and here]. In the end, we might only get a good picture of the vaccine’s side effects long after swine flu has run its course. Then again, with Canada’s lax monitoring system for side effects, we may never know which was worse. Chris Shaw's Key Findings UBC neuroscientist Chris Shaw’s research raises serious questions about a substance used in many vaccines for decades and long thought to be safe—aluminum salt. Shaw started out looking for an explanation for high rates of He found that mice injected with aluminum salt showed symptoms similar to His studies [see here and here] conclude the soldiers may have gotten Aluminum salt isn’t present in the H1N1 vaccine, but it is present in nearly half of all vaccines licensed in Yet, Shaw said no one has followed up on his study to his knowledge. “It’s one of those topics that’s seen as problematic,” he said. “The lack of official curiosity is kind of disturbing.”
What’s in Your H1N1 Flu Vaccine?
Creeping Desert
Will climate change push fertile prairie to desolate wasteland?
By Alex Roslin
Canadian Wildlife
September/October 2009
Water is the lifeblood of the Canadian Prairies—essential for its ecosystems, drinking and economy. But water experts say life could be turned upside down there as climate change brings severe drought, dried-up rivers and near-desertification to the Prairies in coming decades. Some of the impacts are already well underway.
“There is going to be tremendous stress on ecosystems,” says James Byrne, chair of the geography department at the
“There will be a fair amount of problems in terms of agricultural production,” says Suren Kulshreshtha, an agricultural economist at the
Temperatures across the Prairies have already gone up by between one and four degrees Celsius in the past century, depending on the region. By 2100, they’re expected to go up a further 6.5 degrees under a median climate-change forecast in a landmark study coauthored by
Warmer temperatures, in turn, are behind a few parallel trends that are combining to imperil the Prairie water supply: melting glaciers and diminishing snowpacks in the
Some of the hardest hit glaciers are in
But high up in the
“All of a sudden the park needs to be renamed because there are no glaciers,” says Stefan Kienzle, a
Many rivers and streams will dry up, and wildlife that depends on them will be devastated. “A large number of Prairie aquatic species are at risk of extirpation,” the review said.
Byrne, who was one of the lead authors of the study, says the Prairies will eventually turn into an arid tropical zone like
River flows in the three
One of the key unanswered questions is the fate of the massive Columbia Icefield straddling the
But this icefield is also retreating. One of its main components, the Saskatchewan Glacier, which is the primary water source for the
Low river flow in the late summer will have significant implications for wildlife in the watershed, says Kienzle. “It will put more stress on the ecosystem and on all species that depend on the rivers.”
“We were shocked by how extreme the changes in river flows had been,” a profile of Schindler in the journal quoted him saying. He added that the decline of
Free Lunches Come at a Price
In the end, “it’s the patient who pays”
Critics say doctors should be forced to disclose goodies they receive from drug company reps
Alex Roslin
Saturday, September 12, 2009
The Montreal Gazette
Adam Hofmann is used to getting teased about his lunch. It’s not because his mom gave him something uncool to eat. It’s because he paid for it.
Hofmann is a doctor and fifth-year medical resident at
Sales reps from pharmaceutical and medical-equipment companies provide the food and sponsor the speaker at many of the talks, he said.
The sessions, known as “rounds” among doctors, occur two to four times a month within any given hospital discipline like cardiology or internal medicine, Hofmann said.
Drug reps also frequently provide food and sponsor speakers at monthly “grand rounds”—talks to entire hospital departments like pediatrics or family medicine—and “journal clubs,” meetings at restaurants or doctors’ homes at which medical papers are discussed, he said.
While his coworkers partake in sushi takeout or a catered spread, Hofmann sticks to cafeteria fare and braces for the funny looks. He is virtually always the only attendee to pay for his meal. “I have occasionally gotten sarcastic remarks. I’ve been called a ‘pinko’ and a ‘communist’,” he said with a laugh.
With 10 to 20 rounds taking place each day in an academic hospital, Hofmann said staff are able to eat lunch for free all week if they want to, and some do. “A few residents have made it a game to never pay for lunch if at all possible, even going to the length of seeking out lectures they would not otherwise be interested in,” he said.
He estimated that the average resident in academic hospitals eats for free two or three times a week.
For Hofmann, brown-bagging it is a small price to pay to avoid the cozy interactions that many medical professionals have with pharmaceutical sales reps.
Questions about drug marketing practices are coming under growing scrutiny in
Last week, the drug giant Pfizer Inc. agreed to pay $2.3 billion
Little data exists on the extent of the marketing activities in Quebec. One of the few Canadian studies found, in 2006, that 42 per cent of general practitioners in B.C. got visits from drug sales reps several times a week. Two-thirds saw them at least once a month.
The visits are part of vast, multi-billion-dollar marketing campaigns that include food brought to doctors’ offices, restaurant meals, trips, high-paying gigs as consultants and speakers, drug samples, research grants and continuing-education talks that doctors attend to maintain their licences.
Critics say the marketing is poorly regulated and that a growing pile of studies shows the perks sway doctors to prescribe costlier drugs that aren’t necessarily the best ones for their patients—a major reason for soaring health-care costs.
“The gross majority of interactions that physicians have with pharmaceutical companies are unnecessary and problematic,” said Hofmann.
***
Pushing pills involves fantastic amounts of money. In a study in 2008 in the journal Public Library of Science Medicine, two Canadian academics, Joel Lexchin and Marc-André Gagnon, calculated that pharmaceutical companies spent $57.5 billion on marketing in the U.S. in 2004. That was nearly double the $32 billion spent on researching and developing drugs.
The marketing budget included $20.4 billion for an army of 100,000 “detailers,” as the sales reps are known in the business. That worked out to about one detailer for every nine doctors; their numbers had swelled by nearly three times since 1995.
In Canada, there were 5,190 detailers in 2002, or one for each 11.4 doctors, according to a 2006 study by the University of Victoria’s Drug Policy Futures research group.
All those detailers and marketing bucks have big impacts on medical decisions of doctors, according to one of the most comprehensive scientific reviews of the question, done by Dr. Ashley Wazana, now a psychiatrist at the Jewish General.
In a paper in the Journal of the American Medical Association in 2000, he reported that doctors who accepted funding for a trip to a company-sponsored conference prescribed that company’s drugs 80- to 190-percent more often than those who hadn’t.
Those who “occasionally” ate pharma-sponsored meals were 2.7 times more likely to request that the sponsor’s drug be added to a hospital formulary (a hospital-approved list of drugs). Doctors who “often” ate the meals were 14 times more likely to do so.
The review also noted that hearing a drug salesman at a talk led doctors to recommend “inappropriate treatment” more often than other doctors, including treatment that cost more and was more invasive.
Wazana also found that just one in five doctors agreed that pharma reps “fairly portray their product.” Three-quarters of residents said the reps “may use unethical practice.”
Despite this, most doctors have some interaction with detailers. Four in five residents attended industry-paid meals, with the average resident eating on the corporate dime 14 to 15 times a year, Wazana found. Interns did so 31 times a year.
Among doctors, 85 to 87 per cent said they had some interaction with detailers, with an average of three to four encounters a month. Eighty-six per cent accepted free drug samples, and half got research grants.
The interactions start right in med school. A survey of 826
In fact, many doctors rely on detailers more than any other source for information about new drugs.
That study also reviewed 616 prescriptions the doctors had written. The doctors cited pharma reps more often than any other factor as influencing their prescription choice. The reps were cited 39 per cent of the time, far more than concern about the drug’s side effects (17 per cent) or prescribing guidelines developed by the medical community (15 per cent).
The marketing has paid off in spades for the pharmaceutical industry, according to a 2002 study by Yale University marketing professor Dick Wittink. He found that each dollar spent lobbying doctors through sales reps and pharma-sponsored events returned nearly $12 in increased prescriptions for brand-name drugs.
At the Quebec Medical Association, which represents 9,000 doctors and medical students, an official said the research is news to him. “We are not aware of that. We haven’t studied this question,” said Robert Nadon, the association’s director of professional affairs.
“We think doctors are professionals and that they will respect their ethics code.”
Russell Williams, president of Rx&D, the Canadian lobby group for brand-name drug companies, said member companies follow an ethics code, which says product information given to medical professional must be “accurate and fair” and that gifts to doctors can’t be “excessive” and must be limited to “modest meals and/or refreshments.”
The code adds, “Hospitality should not be utilized as the primary access to meet with health care professionals, but as an opportunity to expand the business discussions.”
“I believe our industry is dealing with this issue in an upfront way,” said Williams. “We’re not selling shoes here. These are complex molecules. We need to have dialogue with doctors.
“There is a significant engagement from our side to make sure that the relationship is of the highest ethical standards. It is working quite well.”
Officials at the McGill University Health Centre, the Jewish General and the Centre hospitalier de l’Université de Montréal couldn’t be reached for comment.
The body that represents
Côté referred calls to the Quebec College of Physicians. The college said it expects doctors to abide by its ethics code, which says continuing education classes must be “balanced” and that doctors should avoid conflicts of interest. Doctors can’t accept commissions or benefits for having prescribed a drug, but they can accept “customary presents and gifts of modest value.”
But critics say the rules are nebulous. “It’s so vague as to be completely useless,” Hofmann said.
“Also, there are generally minimal and infrequent repercussions associated with these kinds of ethics code violations.”
“Drug companies would not be detailing physicians if they didn’t have a huge return on investment. They’re in the business of making money,” said Jeff Connell, spokesman for the Canadian Generic Pharmaceutical Association.
Connell said his association’s members lose business and patients pay more when detailers steer doctors to more expensive brand-name drugs that aren’t necessarily more effective than similar generic versions. When a drug’s patent is about to expire, he said, brand-name pharmaceutical companies often make minor changes so they can patent the medicine anew and then get doctors onside with aggressive marketing campaigns.
Indeed, of 177 new drugs approved in Canada since 2001, federal regulators deemed that 156 (or 88 per cent) fell in a category of drugs that show “moderate, little or no therapeutic advantage over comparable medicines.” Just 19 of the drugs were considered “a breakthrough or substantial improvement,” according to data from the federal Patented Medicine Prices Review Board.
Rx&D’s Williams disputed the board’s data, calling it “inadequate in reflecting serious, incremental innovation. It’s not telling the real story.”
***
When Shahram Ahari was hired as a detailer in
“They were 200 or 300 of the most attractive people I had ever seen. The physical appeal was only part of it. They were vivacious, well-coiffured, well-dressed, engaging people,” he said.
The training was part
“It was analogous to training in spy agencies. You instantly suss up the person’s personality and look for points of entry. You capitalize on sexual appeal. My more attractive colleagues would say, ‘I’m going to wear my short skirt today,’ or ‘I’m going to wear my low-cleavage top. He (the doctor) seems to get a kick out of that,’” he said.
His in with many doctors was their belly. “Food is a pretty powerful catalyst for sales. I sometimes saw myself as a glorified caterer,” he said.
Food would often have a greater impact than his best arguments about a drug’s merits. “I would argue with doctors until I was blue in the face (about a drug). Then I’d take them out to dinner and see their (prescription) numbers rise,” he said.
Ahari often provided food at hospital “rounds,” and he was also careful not to neglect the staff at doctors’ offices; they could be useful for scheduling appointments with doctors and putting in a good word about his company’s drugs.
“There’s almost a sub-art to figuring out which food people will like. How successful and delicious your lunch is has a sway in terms of how quickly you can get meetings (with the doctor),” he said.
He rewarded high prescribers with an invitation to join the company’s “speaker’s bureau.” That meant lucrative gigs addressing other doctors at company-sponsored lunch and dinner meetings and medical symposiums. Speakers typically earned $100 to $500 for a lunch or dinner presentation and up to $10,000 for a major conference talk.
“We’re constantly monitoring our return on investment. We’re not a charity,” Ahari said. “There’s no such thing as a free lunch. It’s the patient who pays.”
***
The revelations about drug marketing practices have pushed a few U.S. states to ban gifts to doctors, limit their value or require them to be disclosed publicly.
In
But critics say a handful of academic detailers can’t possibly counter the huge numbers of pharma reps and that doctors have shown they can’t police themselves.
Ahari and Hofmann both said doctors should be forced to publicly disclose any benefits they receive. Another measure, said Hofmann, would be for revenue authorities to require doctors to include free drug samples and meals as income and to tax it.
Ahari said he eventually quit his job as a detailer because of his rising ethical concerns. “Not only are you fooling your (doctor) clients, you’re fooling yourself that you’re doing something good,” he said. “I felt I had become such a calculating social manipulator I would be thinking like a chess game in every social encounter with my girlfriend and family. It was horribly disconcerting.”
Ahari has since spoken before Congress, at medical schools and to the American Medical Association about detailing and conflict of interest. He is now attending medical school himself at the University of California at Davis.
Back at McGill, Hofmann hopes his cafeteria lunches will get a colleague or two to question the price of the food they’re enjoying.
“It’s an obvious stance that physicians should take. Getting gifts from an industry that seeks to manipulate your prescribing practices and may adversely affect your patients is unethical.”
Alex Roslin is vice-president of the Canadian Centre for Investigative Reporting.
