FDA scientists complain to Obama of 'corruption'
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer Ricardo Alonso-zaldivar, Associated Press Writer Thu Jan 8, 6:22 pm ET
WASHINGTON – In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.
"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.
The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA's drug review division a few years ago during the safety debacle involving the painkiller Vioxx.
The FDA declined to publicly respond to the letter, but said it is working to address the concerns.
In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.
"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."
A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.
"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.
FDA spokeswoman Judy Leon said in response: "We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members' concerns and take appropriate action."
Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency's reputation.
The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.
In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.
Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA's in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.
Top FDA managers "committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along," the letter said.
A spokeswoman said the Obama transition team had no comment.
Copyright © 2009 The Associated Press. All rights reserved. The information contained in the AP News report may not be published, broadcast, rewritten or redistributed without the prior written authority of The Associated Press.
http://news.yahoo.com/s/ap/20090108/ap_on_go_ot/fda_dissidents/print
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Friday, January 9, 2009
Saturday, January 3, 2009
The Politics of Marketing Gardasil
August 20, 2008
The Evidence Gap
Drug Makers' Push Leads to Cancer Vaccines' Rise
By ELISABETH ROSENTHAL
In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West's disease of the moment.
Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.
One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion; proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall. Even the normally stingy British National Health Service will start giving the other vaccine — Cervarix, from GlaxoSmithKline — to all 12-year-old girls at school this September.
The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines, which offer some protection against infection from sexually transmitted viruses, are far more expensive than earlier vaccines against other diseases — Gardasil's list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits (and often only partially covered by health insurance).
Award-winning advertising has promoted the vaccines. Before the film "Sex and the City," some moviegoers in the United States saw ads for Gardasil. On YouTube and in advertisements on popular shows like "Law and Order," a multiethnic cast of young professionals urges girls to become "one less statistic" by getting vaccinated.
The vaccine makers have also brought attention to cervical cancer by providing money for activities by patients' and women's groups, doctors and medical experts, lobbyists and political organizations interested in the disease, sometimes in ways that skirt disclosure requirements or obscure the companies' involvement.
Even critics of the marketing efforts recognize the benefits of the vaccines. Girls who get the shots are less likely to have Pap tests with worrisome results that would lead to further treatment, saving themselves anxiety and discomfort and, in those cases, saving money. When it occurs, cervical cancer is a dreadful disease; genital warts, partly prevented by the Merck vaccine, can be a painful nuisance.
But some experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them. They say that because of the aggressive marketing, even parents of girls who are far from being sexually active may feel pressured into giving them a vaccine that is not yet needed and whose long-term impact is still unclear. Legislative efforts to require girls to have the vaccine only add to the pressure.
In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.
"There was incredible pressure from industry and politics," said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the Centers for Disease Control and Prevention that recommended the vaccine for all girls once they reached 11 or 12........Much more at the link
http://www.nytimes.com/2008/08/20/health/policy/20vaccine.html?fta=y&pagewanted=print
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The Evidence Gap
Drug Makers' Push Leads to Cancer Vaccines' Rise
By ELISABETH ROSENTHAL
In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West's disease of the moment.
Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.
One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion; proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall. Even the normally stingy British National Health Service will start giving the other vaccine — Cervarix, from GlaxoSmithKline — to all 12-year-old girls at school this September.
The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines, which offer some protection against infection from sexually transmitted viruses, are far more expensive than earlier vaccines against other diseases — Gardasil's list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits (and often only partially covered by health insurance).
Award-winning advertising has promoted the vaccines. Before the film "Sex and the City," some moviegoers in the United States saw ads for Gardasil. On YouTube and in advertisements on popular shows like "Law and Order," a multiethnic cast of young professionals urges girls to become "one less statistic" by getting vaccinated.
The vaccine makers have also brought attention to cervical cancer by providing money for activities by patients' and women's groups, doctors and medical experts, lobbyists and political organizations interested in the disease, sometimes in ways that skirt disclosure requirements or obscure the companies' involvement.
Even critics of the marketing efforts recognize the benefits of the vaccines. Girls who get the shots are less likely to have Pap tests with worrisome results that would lead to further treatment, saving themselves anxiety and discomfort and, in those cases, saving money. When it occurs, cervical cancer is a dreadful disease; genital warts, partly prevented by the Merck vaccine, can be a painful nuisance.
But some experts worry about the consequences of the rapid rollout of the new vaccines without more medical evidence about how best to deploy them. They say that because of the aggressive marketing, even parents of girls who are far from being sexually active may feel pressured into giving them a vaccine that is not yet needed and whose long-term impact is still unclear. Legislative efforts to require girls to have the vaccine only add to the pressure.
In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.
"There was incredible pressure from industry and politics," said Dr. Jon Abramson, a professor of pediatrics at Wake Forest University who was chairman of the committee of the Centers for Disease Control and Prevention that recommended the vaccine for all girls once they reached 11 or 12........Much more at the link
http://www.nytimes.com/2008/08/20/health/policy/20vaccine.html?fta=y&pagewanted=print
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Friday, January 2, 2009
Fosomax-type drugs linked to jaw necrosis
USC dentist links Fosomax-type drugs to jaw necrosis
Posted On: January 1, 2009 - 5:30pm
Researchers at the University Of Southern California, School Of Dentistry release results of clinical data that links oral bisphosphonates to increased jaw necrosis. The study is among the first to acknowledge that even short-term use of common oral osteoporosis drugs may leave the jaw vulnerable to devastating necrosis, according to the report appearing in the January 1 Journal of the American Dental Association (JADA).
Osteoporosis currently affects 10 million Americans. Fosomax is the most widely prescribed oral bisphosphonate, ranking as the 21st most prescribed drug on the market since 2006, according to a 2007 report released by IMS Health.
"Oral Bisphosphonate Use and the Prevalence of Osteonecrosis of the Jaw: An Institutional Inquiry" is the first large institutional study in the U.S. to investigate the relationship between oral bisphosphonate use and jaw bone death, said principal investigator Parish Sedghizadeh, assistant professor of clinical dentistry with the USC School of Dentistry.
After controlling for referral bias, nine of 208 healthy School of Dentistry patients who take or have taken Fosamax for any length of time were diagnosed with osteonecrosis of the jaw (ONJ). The study's results are in contrast to drug makers' prior assertions that bisphosphonate-related ONJ risk is only noticeable with intravenous use of the drugs, not oral usage, Sedghizadeh said. "We've been told that the risk with oral bisphosphonates is negligible, but four percent is not negligible," he said.
Most doctors who have prescribed bisphosphonates have not told patients about any oral health risks associated with the use of the drugs, despite even short-term usage posing a risk due to the drug's tenacious 10-year half life in bone tissue. Lydia Macwilliams of Los Angeles said no one told her about the risk posed by her three years of Fosamax usage until she became a patient of Sedghizadeh at the School of Dentistry. "I was surprised," she said. "My doctor who prescribed the Fosamax didn't tell me about any possible problems with my teeth."
Macwilliams was especially at risk for complications because she was to have three teeth extracted. The infection is a biofilm bacterial process, meaning that the bacteria infecting the mouth and jaw tissues reside within a slimy matrix that protects the bacteria from many conventional antibiotic treatments, and bisphosphonate use may make the infection more aggressive in adhering to the jaw, Sedghizadeh said. The danger is especially pronounced with procedures that directly expose the jaw bone, such as tooth extractions and other oral surgery. After her extractions, two of the three extraction sites had difficulty healing due to infection, Macwilliams said. Luckily, with treatment as well as the rigorous oral hygiene regimen USC dentists developed especially for patients with a history of bisphosphonate usage, the remaining sites slowly but fully healed. "It took about a year to heal," she said, "but it's doing just fine now."
Sedghizadeh hopes to have other researchers confirm his findings and thus encourage more doctors and dentists to talk with patients about the oral health risks associated with the widely used drugs. The results confirm the suspicions of many in the oral health field, he said. "Here at the School of Dentistry we're getting two or three new patients a week that have bisphosphonate-related ONJ," he said, "and I know we're not the only ones seeing it."
Source: University of Southern California
http://www.sciencecodex.com/usc_dentist_links_fosomaxtype_drugs_to_jaw_necrosis
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Posted On: January 1, 2009 - 5:30pm
Researchers at the University Of Southern California, School Of Dentistry release results of clinical data that links oral bisphosphonates to increased jaw necrosis. The study is among the first to acknowledge that even short-term use of common oral osteoporosis drugs may leave the jaw vulnerable to devastating necrosis, according to the report appearing in the January 1 Journal of the American Dental Association (JADA).
Osteoporosis currently affects 10 million Americans. Fosomax is the most widely prescribed oral bisphosphonate, ranking as the 21st most prescribed drug on the market since 2006, according to a 2007 report released by IMS Health.
"Oral Bisphosphonate Use and the Prevalence of Osteonecrosis of the Jaw: An Institutional Inquiry" is the first large institutional study in the U.S. to investigate the relationship between oral bisphosphonate use and jaw bone death, said principal investigator Parish Sedghizadeh, assistant professor of clinical dentistry with the USC School of Dentistry.
After controlling for referral bias, nine of 208 healthy School of Dentistry patients who take or have taken Fosamax for any length of time were diagnosed with osteonecrosis of the jaw (ONJ). The study's results are in contrast to drug makers' prior assertions that bisphosphonate-related ONJ risk is only noticeable with intravenous use of the drugs, not oral usage, Sedghizadeh said. "We've been told that the risk with oral bisphosphonates is negligible, but four percent is not negligible," he said.
Most doctors who have prescribed bisphosphonates have not told patients about any oral health risks associated with the use of the drugs, despite even short-term usage posing a risk due to the drug's tenacious 10-year half life in bone tissue. Lydia Macwilliams of Los Angeles said no one told her about the risk posed by her three years of Fosamax usage until she became a patient of Sedghizadeh at the School of Dentistry. "I was surprised," she said. "My doctor who prescribed the Fosamax didn't tell me about any possible problems with my teeth."
Macwilliams was especially at risk for complications because she was to have three teeth extracted. The infection is a biofilm bacterial process, meaning that the bacteria infecting the mouth and jaw tissues reside within a slimy matrix that protects the bacteria from many conventional antibiotic treatments, and bisphosphonate use may make the infection more aggressive in adhering to the jaw, Sedghizadeh said. The danger is especially pronounced with procedures that directly expose the jaw bone, such as tooth extractions and other oral surgery. After her extractions, two of the three extraction sites had difficulty healing due to infection, Macwilliams said. Luckily, with treatment as well as the rigorous oral hygiene regimen USC dentists developed especially for patients with a history of bisphosphonate usage, the remaining sites slowly but fully healed. "It took about a year to heal," she said, "but it's doing just fine now."
Sedghizadeh hopes to have other researchers confirm his findings and thus encourage more doctors and dentists to talk with patients about the oral health risks associated with the widely used drugs. The results confirm the suspicions of many in the oral health field, he said. "Here at the School of Dentistry we're getting two or three new patients a week that have bisphosphonate-related ONJ," he said, "and I know we're not the only ones seeing it."
Source: University of Southern California
http://www.sciencecodex.com/usc_dentist_links_fosomaxtype_drugs_to_jaw_necrosis
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Monday, December 29, 2008
Many Older Americans Take Risky Drug Combos
Millions of older Americans use risky drug combos
from The Associated Press
CHICAGO December 24, 2008, 06:24 am ET · At least 2 million older Americans are taking a combination of drugs or supplements that can be a risky mix — from blood thinners and cholesterol pills to aspirin and ginkgo capsules — a new study warns.
Among older men, the numbers are particularly alarming — one in 10 are taking potentially harmful combinations, according to the study.
The results aren't always disastrous, but older people are more vulnerable to side effects and drug-to-drug interactions. And patients need to know that just because lots of medicines and supplements don't require prescriptions doesn't mean they're harmless. Nor are some of these safe to take when you're prescribed other medications.
Experts say the take-home advice is to ask about any side effects of prescription drugs, and tell your doctor before taking other medicines.
The report showing just how many older people are using risky combinations comes from a study of nearly 3,000 interviews with people aged 57 to 85. The research, funded by the National Institutes of Health and University of Chicago, appears in Wednesday's Journal of the American Medical Association.
It's well-known that as people age, their medication use goes up. But the study highlights the potential problems with some sobering statistics.
Ninety-one percent in this age group use at least one medication, often for heart disease and related problems. That translates to more than 50 million people. More than half use at least five remedies, including prescriptions, over-the-counter medicines or supplements.
Virtually every medicine can have side effects, and with so many being used by so many older adults, the potential for harm is high.
For example, warfarin, a potent prescription clot-fighting drug, was often taken with aspirin. Both increase the risk of bleeding, so the odds are even higher when both drugs are taken. The researchers said these risks also occur when warfarin is taken with garlic pills, which some studies have suggested can benefit the heart and help prevent blood clots.
Signs of bleeding problems include bruising easily, hard-to-stop bleeding from the gums or from cuts and blood in the urine.
Other commonly used and risky combinations included:
—Aspirin taken with over-the-counter ginkgo supplements, increasing chances for excess bleeding.
—Lisinopril, a blood pressure drug, taken with potassium, which combined can cause abnormal heart rhythms. Potassium is often prescribed to restore low levels of this important mineral caused by certain blood pressure drugs.
—Prescription cholesterol drugs called statins taken with over-the-counter niacin, a type of vitamin B that also lowers cholesterol. This combination increases risks for muscle damage.
"Patients need to know that while medications are often beneficial, they're not always safe," said lead author Dima Qato, a University of Chicago pharmacist. "If they need to self-medicate with over-the-counter or dietary supplements, they should definitely consult with their physicians or pharmacists."
The study relied on data from in-person interviews with 2,976 adults questioned about which medications they routinely used. The nationally representative survey was done between June 2005 and March 2006, and results were extrapolated to the general population.
The researchers assessed how many people routinely used at least two medications of any type known to have dangerous or even fatal interactions. The number totaled at least one in 25, corresponding to 2.2 million nationwide.
Those interviewed weren't asked if they'd ever had a bad reaction from taking those combinations. And the study didn't assess whether patients were taking medications inappropriately.
Dr. Jerry Gurwitz, chief of the geriatric medicine division at University of Massachusetts Medical School, said taking multiple medications, despite possible bad interactions, isn't necessarily a bad idea as long as patients are in close contact with their doctor.
"There are definitely many instances where if they're monitored carefully and there's good reason for using them, that they could be used safely," said Gurwitz, who wasn't involved in the study.
Prescription drugs were the most commonly used and nearly one-third used at least five prescription drugs.
Michael Cohen, a pharmacist and president of the Institute for Safe Medication Practices, called the study an important snapshot of medication use in older Americans. But as someone who takes at least five medications himself, Cohen said the widespread prevalence isn't surprising.
Cohen said his group recently launched a new Web site, http://www.consumermedsafety.org that will allow consumers to enter names of their medications to check for any potentially dangerous interactions.
———
On the Net:
JAMA: http://jama.ama-assn.org
Institute for Safe Medication Practices: http://www.ismp.org
http://www.npr.org/templates/story/story.php?storyId=98676403
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from The Associated Press
CHICAGO December 24, 2008, 06:24 am ET · At least 2 million older Americans are taking a combination of drugs or supplements that can be a risky mix — from blood thinners and cholesterol pills to aspirin and ginkgo capsules — a new study warns.
Among older men, the numbers are particularly alarming — one in 10 are taking potentially harmful combinations, according to the study.
The results aren't always disastrous, but older people are more vulnerable to side effects and drug-to-drug interactions. And patients need to know that just because lots of medicines and supplements don't require prescriptions doesn't mean they're harmless. Nor are some of these safe to take when you're prescribed other medications.
Experts say the take-home advice is to ask about any side effects of prescription drugs, and tell your doctor before taking other medicines.
The report showing just how many older people are using risky combinations comes from a study of nearly 3,000 interviews with people aged 57 to 85. The research, funded by the National Institutes of Health and University of Chicago, appears in Wednesday's Journal of the American Medical Association.
It's well-known that as people age, their medication use goes up. But the study highlights the potential problems with some sobering statistics.
Ninety-one percent in this age group use at least one medication, often for heart disease and related problems. That translates to more than 50 million people. More than half use at least five remedies, including prescriptions, over-the-counter medicines or supplements.
Virtually every medicine can have side effects, and with so many being used by so many older adults, the potential for harm is high.
For example, warfarin, a potent prescription clot-fighting drug, was often taken with aspirin. Both increase the risk of bleeding, so the odds are even higher when both drugs are taken. The researchers said these risks also occur when warfarin is taken with garlic pills, which some studies have suggested can benefit the heart and help prevent blood clots.
Signs of bleeding problems include bruising easily, hard-to-stop bleeding from the gums or from cuts and blood in the urine.
Other commonly used and risky combinations included:
—Aspirin taken with over-the-counter ginkgo supplements, increasing chances for excess bleeding.
—Lisinopril, a blood pressure drug, taken with potassium, which combined can cause abnormal heart rhythms. Potassium is often prescribed to restore low levels of this important mineral caused by certain blood pressure drugs.
—Prescription cholesterol drugs called statins taken with over-the-counter niacin, a type of vitamin B that also lowers cholesterol. This combination increases risks for muscle damage.
"Patients need to know that while medications are often beneficial, they're not always safe," said lead author Dima Qato, a University of Chicago pharmacist. "If they need to self-medicate with over-the-counter or dietary supplements, they should definitely consult with their physicians or pharmacists."
The study relied on data from in-person interviews with 2,976 adults questioned about which medications they routinely used. The nationally representative survey was done between June 2005 and March 2006, and results were extrapolated to the general population.
The researchers assessed how many people routinely used at least two medications of any type known to have dangerous or even fatal interactions. The number totaled at least one in 25, corresponding to 2.2 million nationwide.
Those interviewed weren't asked if they'd ever had a bad reaction from taking those combinations. And the study didn't assess whether patients were taking medications inappropriately.
Dr. Jerry Gurwitz, chief of the geriatric medicine division at University of Massachusetts Medical School, said taking multiple medications, despite possible bad interactions, isn't necessarily a bad idea as long as patients are in close contact with their doctor.
"There are definitely many instances where if they're monitored carefully and there's good reason for using them, that they could be used safely," said Gurwitz, who wasn't involved in the study.
Prescription drugs were the most commonly used and nearly one-third used at least five prescription drugs.
Michael Cohen, a pharmacist and president of the Institute for Safe Medication Practices, called the study an important snapshot of medication use in older Americans. But as someone who takes at least five medications himself, Cohen said the widespread prevalence isn't surprising.
Cohen said his group recently launched a new Web site, http://www.consumermedsafety.org that will allow consumers to enter names of their medications to check for any potentially dangerous interactions.
———
On the Net:
JAMA: http://jama.ama-assn.org
Institute for Safe Medication Practices: http://www.ismp.org
http://www.npr.org/templates/story/story.php?storyId=98676403
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Vaccine Charges etc.
NPR's morning edition had this interesting news article on vaccine problems which have everything to do with finances and medical policies and nothing to do with the so-called "anti-vaccination crowd."
Charges For Vaccines Vary Widely, Study Finds
by Brenda Wilson
Morning Edition, December 29, 2008 · A study published in this month's Pediatrics journal found that there was an exceedingly wide variation not only in what pediatricians and family practitioners paid for vaccines, but also in the reimbursements they received from insurers and managed care organizations.
Dr. Gary Freed of the University of Michigan Health Systems says he undertook a study of physician costs associated with childhood immunization because he kept hearing complaints from physicians that they couldn't make ends meet and were losing money on immunizations.
"It turns out," Freed says, "that some physicians were paying over three times what other physicians were for the exact same vaccine. By the same token, we found that some physicians were being reimbursed twice as much as other physicians for the same vaccine. So, some were paying too much and getting reimbursed too little."
For example, the study showed that some doctors reported buying the vaccine for chickenpox (varicella) for about $66 a dose. Other physicians paid as much as $87 for the same vaccine. Reimbursement from the most common insurers was as low as $57.
Some Physicians Unsure Of Costs
Private practices are like small business. But that's not how many physicians run them. When Freed called some physicians he says he found "some physicians that quite honestly didn't know what they were paying for vaccines and had to dig up records and make new calculations to figure that out."
As late as 2000, the study shows, the full course for the recommended schedule of childhood vaccines cost $600 per child in the private sector. Now, with more than 20 recommended childhood vaccines, the cost is up to $1,500.
Richard Lander, a pediatrician in Livingston, N.J., became aware of the costs as the number of childhood immunizations grew along with those costs. He says he stopped buying the vaccines directly from the manufacturers and started shopping around. He noticed that he would pay one price for the vaccine, and the insurer would reimburse him $1 less. He began keeping close tabs.
He says he began tracking where he bought the vaccines and whether he was able to get them at a good price or not.
"We will bill for the vaccine we've administered and we will bill for the vaccine administration fee. Many managed care organizations will say 'Why are you so interested in getting paid more for the vaccine administration fee? Look how well I pay you for the vaccine.' We're talking about a product and we're talking about a service. Don't pay me for one and not pay me for the other," he says.
Costs Add Up
Those aren't the only costs associated with childhood immunization that physicians must bear. There are the administrative costs for the time and staff to keep record of vaccinations and to order and stock the vaccines. There's the cost of refrigerators to store vaccines and the costs of electricity and insurance.
As a consequence, many physicians are in fact losing money on childhood immunizations.
"Some of these vaccines cost over $100 a dose and if you are thinking about stocking 60 to 100 doses in your practice, that is a significant outlay," he says.
It can take anywhere from 30 to 90 days for physicians to be reimbursed.
At least a fifth of family practitioners say they can no longer afford to vaccinate children, which can be a problem particularly in rural areas of the country where there are often no alternatives. Only 5 percent of pediatricians say they are considering not vaccinating, but 40 percent of them feel inadequately paid by insurers, according to the study.
The government buys about half of all vaccines that are provided free for children who are not insured. Ninety percent, however, are administered by private practitioners, and the government pays only a nominal fee — about $11 —for administering the vaccine.
Susan Pisano, a spokesperson for the health insurer advocacy group America's Health Insurance Plans, says private insurers are being asked to pick up the government's slack.
"What has happened is that because government, Medicare and Medicaid typically pays providers, doctors and hospitals less, those doctors and hospitals have been expecting greater payment from employer-sponsored plans," she says. "Most doctors and pediatricians are operating at a profit and employers and consumers should not have to pay for the inefficient ones."
Looking Ahead
To reduce his costs, Lander who chairs a committee of the American Academy of Pediatrics on managing practices, has also been working with other pediatricians to get better reimbursement rates. He started a group purchasing organization. Doctors who join can buy vaccines at a discount.
But he says he's still losing money on insurers. One insurer wanted to pay him even less than the federal government does. He dropped the company. Patients covered by the company who decided to stay with him got medical care at a discount.
Organizing would help, Freed says, but pediatricians and family practitioners are working at a disadvantage in that physicians are barred by law from sharing information about costs and reimbursements.
http://www.npr.org/templates/story/story.php?storyId=98743907
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Charges For Vaccines Vary Widely, Study Finds
by Brenda Wilson
Morning Edition, December 29, 2008 · A study published in this month's Pediatrics journal found that there was an exceedingly wide variation not only in what pediatricians and family practitioners paid for vaccines, but also in the reimbursements they received from insurers and managed care organizations.
Dr. Gary Freed of the University of Michigan Health Systems says he undertook a study of physician costs associated with childhood immunization because he kept hearing complaints from physicians that they couldn't make ends meet and were losing money on immunizations.
"It turns out," Freed says, "that some physicians were paying over three times what other physicians were for the exact same vaccine. By the same token, we found that some physicians were being reimbursed twice as much as other physicians for the same vaccine. So, some were paying too much and getting reimbursed too little."
For example, the study showed that some doctors reported buying the vaccine for chickenpox (varicella) for about $66 a dose. Other physicians paid as much as $87 for the same vaccine. Reimbursement from the most common insurers was as low as $57.
Some Physicians Unsure Of Costs
Private practices are like small business. But that's not how many physicians run them. When Freed called some physicians he says he found "some physicians that quite honestly didn't know what they were paying for vaccines and had to dig up records and make new calculations to figure that out."
As late as 2000, the study shows, the full course for the recommended schedule of childhood vaccines cost $600 per child in the private sector. Now, with more than 20 recommended childhood vaccines, the cost is up to $1,500.
Richard Lander, a pediatrician in Livingston, N.J., became aware of the costs as the number of childhood immunizations grew along with those costs. He says he stopped buying the vaccines directly from the manufacturers and started shopping around. He noticed that he would pay one price for the vaccine, and the insurer would reimburse him $1 less. He began keeping close tabs.
He says he began tracking where he bought the vaccines and whether he was able to get them at a good price or not.
"We will bill for the vaccine we've administered and we will bill for the vaccine administration fee. Many managed care organizations will say 'Why are you so interested in getting paid more for the vaccine administration fee? Look how well I pay you for the vaccine.' We're talking about a product and we're talking about a service. Don't pay me for one and not pay me for the other," he says.
Costs Add Up
Those aren't the only costs associated with childhood immunization that physicians must bear. There are the administrative costs for the time and staff to keep record of vaccinations and to order and stock the vaccines. There's the cost of refrigerators to store vaccines and the costs of electricity and insurance.
As a consequence, many physicians are in fact losing money on childhood immunizations.
"Some of these vaccines cost over $100 a dose and if you are thinking about stocking 60 to 100 doses in your practice, that is a significant outlay," he says.
It can take anywhere from 30 to 90 days for physicians to be reimbursed.
At least a fifth of family practitioners say they can no longer afford to vaccinate children, which can be a problem particularly in rural areas of the country where there are often no alternatives. Only 5 percent of pediatricians say they are considering not vaccinating, but 40 percent of them feel inadequately paid by insurers, according to the study.
The government buys about half of all vaccines that are provided free for children who are not insured. Ninety percent, however, are administered by private practitioners, and the government pays only a nominal fee — about $11 —for administering the vaccine.
Susan Pisano, a spokesperson for the health insurer advocacy group America's Health Insurance Plans, says private insurers are being asked to pick up the government's slack.
"What has happened is that because government, Medicare and Medicaid typically pays providers, doctors and hospitals less, those doctors and hospitals have been expecting greater payment from employer-sponsored plans," she says. "Most doctors and pediatricians are operating at a profit and employers and consumers should not have to pay for the inefficient ones."
Looking Ahead
To reduce his costs, Lander who chairs a committee of the American Academy of Pediatrics on managing practices, has also been working with other pediatricians to get better reimbursement rates. He started a group purchasing organization. Doctors who join can buy vaccines at a discount.
But he says he's still losing money on insurers. One insurer wanted to pay him even less than the federal government does. He dropped the company. Patients covered by the company who decided to stay with him got medical care at a discount.
Organizing would help, Freed says, but pediatricians and family practitioners are working at a disadvantage in that physicians are barred by law from sharing information about costs and reimbursements.
http://www.npr.org/templates/story/story.php?storyId=98743907
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Thursday, December 25, 2008
Mass Media Science Reporting with reference to misleading statistics about statins
Making Sense of Science Reporting
By Deborah Howell
Sunday, December 7, 2008; B06
The job of science reporters is to take complicated subjects and translate them for readers who are not scientifically sophisticated. Critics say that the news media oversimplify and aren't skeptical enough of financing by special interests.
That led me to review papers that are to be published soon as part of a project sponsored by the American Academy of Arts and Sciences on how the media cover science and technology, and to interview a half-dozen experts, from scientists to teachers of science writing. Here's my take:
· Look for the evidence. News organizations should give weight to scientific evidence, whether it is about global warming or what the medical establishment says about Lyme disease.
Post science reporter David Brown, who is also a physician, talked about this in a recent speech at the University of Iowa. It will be published next year. "In science, there is a natural tension between evidence and opinion, and evidence always wins. What authority figures have to say about anything in science is ultimately irrelevant. Unfortunately, in a lot of science reporting, as in a lot of reporting in general, that isn't the case.''(my italics)
Science reporters should give readers enough information to judge "the strength of a claim" and report "how the news fits into what's already known about the subject," Brown said. "It isn't always easy to boil down research findings to a few numbers that capture the essence" of a study. "Sometimes it can't be done or can't be done on deadline," he said. So follow-ups are important.
Brown recommends noticing how much space in an article is devoted to describing the evidence of the newsworthiness of the story and how much is devoted to someone telling you what to think about it. "If there isn't enough information to give you, the reader, a fighting chance to decide for yourself whether something is important, then somebody isn't doing his job, or hers."
· Look for context. Are the results preliminary? Does the research conflict with or confirm earlier work? Has it been published in a reputable science journal or been presented at a science meeting?
· Look beyond the lead paragraph and headline. Remember that antioxidants were touted to prevent all sorts of disease; research proved that not to be true. One recent Page 1 story, by veteran Post science reporter Rob Stein, attracted comment and criticism. Stein wrote that a study produced "powerful evidence" that a blood test designed to monitor inflammation could identify "seemingly healthy people who are at increased risk for a heart attack or stroke" and that a widely used statin drug offered "potent protection against the nation's leading killers." The story quoted the study's author and other prominent experts as calling the findings a "breakthrough," a "blockbuster" and "absolutely paradigm-shifting."
The Foundation for Integrative AIDS Research (FIAR) -- which has a stake in the issue because AIDS drugs can raise "bad" cholesterol levels -- said stories about the study reflected "shoddy boosterism for the pharmaceutical industry rather than a careful and balanced analysis."
FIAR Director George M. Carter's chief complaint was that stories emphasized a change in "relative risk" -- a 44 percent fall in the number of heart attacks, strokes and surgical procedures among people taking the statin, compared with those in the placebo group. He said the fact that everyone in the study had an extremely low "absolute risk" for heart problems should have been emphasized more. About 1.36 percent of people taking the placebo suffered a heart attack or stroke; that fell to 0.8 percent among those taking the statin. That means that nearly 97 percent of the people using the drug would not see any benefit, he said.
Stein quoted a skeptic in the ninth paragraph and noted near the story's end that "the actual risk reduction for an individual would be very small, given the relatively low risk for most middle-age people, so that the benefits easily could be outweighed by the costs of thousands more people taking tests, drugs and being monitored by doctors."
Stein said, "While I would have liked to have explored many of the nuances of this study more fully, I feel confident we struck a responsible balance. I think it's crucial to provide readers with both the evidence supporting new claims and enough context and interpretation to help them gauge its significance." Independent experts, he said, concluded the study was "a very well done, very convincing piece of research."
One of the issues in science reporting is that most readers aren't schooled in statistics. Harold Varmus, former director of the National Institutes of Health, recommends looking more deeply into the numbers. "The percentages may be high, but what is the risk of an event in the first place? If the risk is low, there's a much smaller benefit." Varmus, a Nobel laureate, is chief executive of Memorial Sloan-Kettering Cancer Center.
Marcia Angell, a physician and former editor of the New England Journal of Medicine who is now a senior lecturer at Harvard Medical School, said journalists can write "overly dramatic" stories for "gullible" readers. "Everyone has an interest in hyping news of medical research -- the researcher, the institution, reporters. Readers should be very skeptical of new findings. Newspapers are in the business of telling you the news, which needs to be startling or counterintuitive or flies in the face of what we knew. By definition these stories are less likely to be accurate."
Don J. Melnick, professor of conservation biology at Columbia University, said that if a story "doesn't sound newsworthy or front page-worthy, it will be buried or not printed at all. That tends to promote people hyping the research. They have to convince their editors to put it in the paper."
Nils Bruzelius, The Post's science editor, said, "I thought the story and Page 1 play were justified because the potential impact was significant, even as I understand the criticisms. There's an inevitable tension between the desire of reporters and editors to get good play for their stories and the need to avoid hype or overstatement, and we feel this very acutely in dealing with scientific or medical stories, because the advances, even those that prove to be part of something very big, usually come in incremental steps. I've long believed that science and medical stories enter this competition at some disadvantage. I certainly don't have data on this but I suspect that most of the top editors who make the front-page decisions tend to be less drawn to these topics than the average reader because, with a few exceptions, they are a naturally self-selected group who got to where they are by dint of their interest and ability in covering such topics as politics, international relations, war and national security -- not science."
· Who sponsored the research and who makes money from its findings? Angell, a critic of drug companies' influence on medical research, said, "The caveats are at the end [of the story]. The pharmaceutical industry is spreading money everywhere and the researchers have their hands out."
That was true of the statin story. In the last six paragraphs, readers learned that the study was financed by AstraZeneca, which makes the statin Crestor, and that the study's author and his hospital will receive royalties on the blood test that was studied. Drugmakers fund many large medical studies. The story said that the company had no influence over the analysis.
Varmus said there is no mechanism for support or motivation to conduct clinical trials without drug industry money. "Obviously, companies have a vested interest in a good outcome and being truthful and getting answers that won't cause them grief later on," he said. Such trials also must follow Food and Drug Administration regulations.
"It's not new that the industry is the primary source of funding clinical research," Angell said. "What is new is the strings attached and the willingness of medical schools and faculty to accept these strings. They have influence over every detail of clinical trials."
Jonathan Weiner, who teaches science writing at the Columbia University Graduate School of Journalism, said, "It's a very messy, complicated problem. With government funding tight, many doctors rely on industry for funding. People in research medicine can't stay current without going to industry-funded conferences that have the quality of junkets." Weiner wrote "The Beak of the Finch," a book about evolutionary biology that won the Pulitzer Prize for general nonfiction in 1995.
For readers, Brown's best advice is this: "In the end, all that counts is evidence."
A longer version of this column appears online. Deborah Howell can be reached at 202-334-7582 or at ombudsman@washpost.com.
View all comments
http://www.washingtonpost.com/wp-dyn/content/article/2008/12/05/AR2008120502959_pf.html
null
By Deborah Howell
Sunday, December 7, 2008; B06
The job of science reporters is to take complicated subjects and translate them for readers who are not scientifically sophisticated. Critics say that the news media oversimplify and aren't skeptical enough of financing by special interests.
That led me to review papers that are to be published soon as part of a project sponsored by the American Academy of Arts and Sciences on how the media cover science and technology, and to interview a half-dozen experts, from scientists to teachers of science writing. Here's my take:
· Look for the evidence. News organizations should give weight to scientific evidence, whether it is about global warming or what the medical establishment says about Lyme disease.
Post science reporter David Brown, who is also a physician, talked about this in a recent speech at the University of Iowa. It will be published next year. "In science, there is a natural tension between evidence and opinion, and evidence always wins. What authority figures have to say about anything in science is ultimately irrelevant. Unfortunately, in a lot of science reporting, as in a lot of reporting in general, that isn't the case.''(my italics)
Science reporters should give readers enough information to judge "the strength of a claim" and report "how the news fits into what's already known about the subject," Brown said. "It isn't always easy to boil down research findings to a few numbers that capture the essence" of a study. "Sometimes it can't be done or can't be done on deadline," he said. So follow-ups are important.
Brown recommends noticing how much space in an article is devoted to describing the evidence of the newsworthiness of the story and how much is devoted to someone telling you what to think about it. "If there isn't enough information to give you, the reader, a fighting chance to decide for yourself whether something is important, then somebody isn't doing his job, or hers."
· Look for context. Are the results preliminary? Does the research conflict with or confirm earlier work? Has it been published in a reputable science journal or been presented at a science meeting?
· Look beyond the lead paragraph and headline. Remember that antioxidants were touted to prevent all sorts of disease; research proved that not to be true. One recent Page 1 story, by veteran Post science reporter Rob Stein, attracted comment and criticism. Stein wrote that a study produced "powerful evidence" that a blood test designed to monitor inflammation could identify "seemingly healthy people who are at increased risk for a heart attack or stroke" and that a widely used statin drug offered "potent protection against the nation's leading killers." The story quoted the study's author and other prominent experts as calling the findings a "breakthrough," a "blockbuster" and "absolutely paradigm-shifting."
The Foundation for Integrative AIDS Research (FIAR) -- which has a stake in the issue because AIDS drugs can raise "bad" cholesterol levels -- said stories about the study reflected "shoddy boosterism for the pharmaceutical industry rather than a careful and balanced analysis."
FIAR Director George M. Carter's chief complaint was that stories emphasized a change in "relative risk" -- a 44 percent fall in the number of heart attacks, strokes and surgical procedures among people taking the statin, compared with those in the placebo group. He said the fact that everyone in the study had an extremely low "absolute risk" for heart problems should have been emphasized more. About 1.36 percent of people taking the placebo suffered a heart attack or stroke; that fell to 0.8 percent among those taking the statin. That means that nearly 97 percent of the people using the drug would not see any benefit, he said.
Stein quoted a skeptic in the ninth paragraph and noted near the story's end that "the actual risk reduction for an individual would be very small, given the relatively low risk for most middle-age people, so that the benefits easily could be outweighed by the costs of thousands more people taking tests, drugs and being monitored by doctors."
Stein said, "While I would have liked to have explored many of the nuances of this study more fully, I feel confident we struck a responsible balance. I think it's crucial to provide readers with both the evidence supporting new claims and enough context and interpretation to help them gauge its significance." Independent experts, he said, concluded the study was "a very well done, very convincing piece of research."
One of the issues in science reporting is that most readers aren't schooled in statistics. Harold Varmus, former director of the National Institutes of Health, recommends looking more deeply into the numbers. "The percentages may be high, but what is the risk of an event in the first place? If the risk is low, there's a much smaller benefit." Varmus, a Nobel laureate, is chief executive of Memorial Sloan-Kettering Cancer Center.
Marcia Angell, a physician and former editor of the New England Journal of Medicine who is now a senior lecturer at Harvard Medical School, said journalists can write "overly dramatic" stories for "gullible" readers. "Everyone has an interest in hyping news of medical research -- the researcher, the institution, reporters. Readers should be very skeptical of new findings. Newspapers are in the business of telling you the news, which needs to be startling or counterintuitive or flies in the face of what we knew. By definition these stories are less likely to be accurate."
Don J. Melnick, professor of conservation biology at Columbia University, said that if a story "doesn't sound newsworthy or front page-worthy, it will be buried or not printed at all. That tends to promote people hyping the research. They have to convince their editors to put it in the paper."
Nils Bruzelius, The Post's science editor, said, "I thought the story and Page 1 play were justified because the potential impact was significant, even as I understand the criticisms. There's an inevitable tension between the desire of reporters and editors to get good play for their stories and the need to avoid hype or overstatement, and we feel this very acutely in dealing with scientific or medical stories, because the advances, even those that prove to be part of something very big, usually come in incremental steps. I've long believed that science and medical stories enter this competition at some disadvantage. I certainly don't have data on this but I suspect that most of the top editors who make the front-page decisions tend to be less drawn to these topics than the average reader because, with a few exceptions, they are a naturally self-selected group who got to where they are by dint of their interest and ability in covering such topics as politics, international relations, war and national security -- not science."
· Who sponsored the research and who makes money from its findings? Angell, a critic of drug companies' influence on medical research, said, "The caveats are at the end [of the story]. The pharmaceutical industry is spreading money everywhere and the researchers have their hands out."
That was true of the statin story. In the last six paragraphs, readers learned that the study was financed by AstraZeneca, which makes the statin Crestor, and that the study's author and his hospital will receive royalties on the blood test that was studied. Drugmakers fund many large medical studies. The story said that the company had no influence over the analysis.
Varmus said there is no mechanism for support or motivation to conduct clinical trials without drug industry money. "Obviously, companies have a vested interest in a good outcome and being truthful and getting answers that won't cause them grief later on," he said. Such trials also must follow Food and Drug Administration regulations.
"It's not new that the industry is the primary source of funding clinical research," Angell said. "What is new is the strings attached and the willingness of medical schools and faculty to accept these strings. They have influence over every detail of clinical trials."
Jonathan Weiner, who teaches science writing at the Columbia University Graduate School of Journalism, said, "It's a very messy, complicated problem. With government funding tight, many doctors rely on industry for funding. People in research medicine can't stay current without going to industry-funded conferences that have the quality of junkets." Weiner wrote "The Beak of the Finch," a book about evolutionary biology that won the Pulitzer Prize for general nonfiction in 1995.
For readers, Brown's best advice is this: "In the end, all that counts is evidence."
A longer version of this column appears online. Deborah Howell can be reached at 202-334-7582 or at ombudsman@washpost.com.
View all comments
http://www.washingtonpost.com/wp-dyn/content/article/2008/12/05/AR2008120502959_pf.html
null
Friday, December 19, 2008
Did a "big pharma" company contaminate a Nobel Prize selection?
From The Times
December 19, 2008
AstraZeneca row as corruption claims engulf Nobel prize
David Charter
The integrity of the Nobel prize was called into question last night after it emerged that a member of the jury also sat on the board of a pharmaceuticals giant that benefited from the award of this year's prize for medicine.
Prosecutors were studying whether AstraZeneca, the London-based multi-national pharmaceutical company, could have exerted undue influence on the award.
The joint winner of this year's Nobel Prize for Medicine, Harald zur Hausen, was recognised for his work on the human papilloma virus (HPV), which can lead to cervical cancer. AstraZeneca has a stake in two lucrative vaccines against the virus.
Two senior figures in the process that chose Mr zur Hausen have strong links with the pharmaceutical company, which has also recently begun sponsoring the Nobel website and pro-motional subsidiary. The company strongly denies any wrongdoing.
It is not the only question mark hanging over the probity of the Stockholm-based foundation. The Swedish prosecutor yesterday opened a parallel investigation into bribery allegations after several members of Nobel committees admitted enjoying expenses-paid trips to China to tell officials how candidates are selected for prizes.
Other members of the Nobel Foundation are said to be gravely concerned that the reputation of an organisation that honours the highest achievements in human endeavour is under threat from companies and nations hungry for Nobel glory.
Questions began to be asked about AstraZeneca's role after it agreed to sponsor Nobel Media and Nobel Web. Neither the company nor the foundation will say how much the contracts are worth, although they are estimated to run into hundreds of thousands of dollars over the next three years.
Further concerns were raised by Swedish radio, which revealed that Bertil Fredholm, the chairman of the five-strong committee that assesses Nobel candidates, was a paid consultant for AstraZeneca in 2006. Bo Angelin, a member of the 50-strong committee that votes for the winner, also sits on the board.
Last year, AstraZeneca acquired a company that developed a key component licensed for the production of two HPV vaccines made by other companies.
Christer van der Kwast, the director of the Swedish police anticorruption unit, ordered a preliminary investigation. His actions have been dismissed by Michael Sohlman, executive director of the Nobel Foundation, who told Scientific American magazine: "How should I put this? He often appears in the media."
Mr van der Kwast told The Times last night: "My initiative was to look into this to see if there were grounds for investigation. I have ordered the prosecutor-in-charge to look into this."
A spokesman for AstraZeneca rejected any suggestion that its influence over the Nobel Foundation was improper. He said: "We have no influence over the prizewinners nor would we ever seek to.AstraZeneca as a company is not involved in the process of Nobel prize selection. Bo Angelin's involvement on the Nobel committee is completely independent of his role on AstraZeneca's board. Bertil Fredholm is a well-respected expert. He did some work for us in 2006, as we work with many people who are experts in their field. The relationship was . . . no more than that.".......
http://www.timesonline.co.uk/tol/news/world/europe/article5367941.ece?print=yes&randnum=1229699021867
null
December 19, 2008
AstraZeneca row as corruption claims engulf Nobel prize
David Charter
The integrity of the Nobel prize was called into question last night after it emerged that a member of the jury also sat on the board of a pharmaceuticals giant that benefited from the award of this year's prize for medicine.
Prosecutors were studying whether AstraZeneca, the London-based multi-national pharmaceutical company, could have exerted undue influence on the award.
The joint winner of this year's Nobel Prize for Medicine, Harald zur Hausen, was recognised for his work on the human papilloma virus (HPV), which can lead to cervical cancer. AstraZeneca has a stake in two lucrative vaccines against the virus.
Two senior figures in the process that chose Mr zur Hausen have strong links with the pharmaceutical company, which has also recently begun sponsoring the Nobel website and pro-motional subsidiary. The company strongly denies any wrongdoing.
It is not the only question mark hanging over the probity of the Stockholm-based foundation. The Swedish prosecutor yesterday opened a parallel investigation into bribery allegations after several members of Nobel committees admitted enjoying expenses-paid trips to China to tell officials how candidates are selected for prizes.
Other members of the Nobel Foundation are said to be gravely concerned that the reputation of an organisation that honours the highest achievements in human endeavour is under threat from companies and nations hungry for Nobel glory.
Questions began to be asked about AstraZeneca's role after it agreed to sponsor Nobel Media and Nobel Web. Neither the company nor the foundation will say how much the contracts are worth, although they are estimated to run into hundreds of thousands of dollars over the next three years.
Further concerns were raised by Swedish radio, which revealed that Bertil Fredholm, the chairman of the five-strong committee that assesses Nobel candidates, was a paid consultant for AstraZeneca in 2006. Bo Angelin, a member of the 50-strong committee that votes for the winner, also sits on the board.
Last year, AstraZeneca acquired a company that developed a key component licensed for the production of two HPV vaccines made by other companies.
Christer van der Kwast, the director of the Swedish police anticorruption unit, ordered a preliminary investigation. His actions have been dismissed by Michael Sohlman, executive director of the Nobel Foundation, who told Scientific American magazine: "How should I put this? He often appears in the media."
Mr van der Kwast told The Times last night: "My initiative was to look into this to see if there were grounds for investigation. I have ordered the prosecutor-in-charge to look into this."
A spokesman for AstraZeneca rejected any suggestion that its influence over the Nobel Foundation was improper. He said: "We have no influence over the prizewinners nor would we ever seek to.AstraZeneca as a company is not involved in the process of Nobel prize selection. Bo Angelin's involvement on the Nobel committee is completely independent of his role on AstraZeneca's board. Bertil Fredholm is a well-respected expert. He did some work for us in 2006, as we work with many people who are experts in their field. The relationship was . . . no more than that.".......
http://www.timesonline.co.uk/tol/news/world/europe/article5367941.ece?print=yes&randnum=1229699021867
null
Tuesday, November 18, 2008
Call for Caution in the Rush to Statins- New York Times
November 18, 2008
Well
A Call for Caution in the Rush to Statins
By TARA PARKER-POPE
Is it time to put cholesterol-lowering statin drugs in every medicine cabinet?
Judging by recent headlines, you might think so. Last week heart researchers reported that millions of healthy people could benefit from taking statins even if they don't have high cholesterol.
Although many doctors hailed the study as a major breakthrough, a closer look at the research suggests that statins (like Crestor, from AstraZeneca, and Lipitor, from Pfizer) are far from magic pills. While they clearly save lives in people with a previous heart attack or other serious heart problems, for an otherwise healthy person the potential benefit remains small.
Many doctors who believe in using statins for heart disease say they needn't be given to healthy patients. Instead, they say, the focus should remain on encouraging healthful behavior and screening for traditional risk factors like high blood pressure and cholesterol.
"Statins have many biological effects that appear to be quite meaningful," said Dr. Valentin Fuster, director of the heart program at Mount Sinai Medical Center in Manhattan and past president of the American Heart Association. "But I don't think the answer is a magic drug to prevent disease. The answer is to change behavior."
Still, the latest study, called Jupiter, is sure to fuel interest in a blood test for something called C-reactive protein, or CRP. The test, which can cost $20 to $50, measures inflammation. Studies have shown that patients with high CRP are at higher risk for heart attack, even if they have normal cholesterol.
The researchers sought out men 50 and older and women 60 and older who had elevated CRP but not high cholesterol. The goal was to determine whether statins could improve their health.
But of nearly 90,000 people who were screened, only 17,802 were selected. That means 80 percent of the recruits were excluded for a variety of reasons — another inflammatory condition like arthritis, medication use, high blood pressure, a history of cancer and so on.
"If you extrapolate that, it means there are not all that many people exactly like those who were studied," said Dr. Nieca Goldberg, director of the women's heart program at New York University Langone Medical Center.
"But I can see a lot of people will be wanting a CRP test," she went on. "My greatest concern is that there will be many people who don't fit the criteria of the study, but based on this they will get blood tests and statin therapy."
And because of the way the Jupiter results were reported, many healthy people are likely to get an exaggerated view of statins' benefits. While the investigators reported an impressive-sounding 50 percent reduction in the risk of serious heart problems among the statin users, in reality everyone in the study had a low risk to begin with.
Only 1.8 percent of the subjects who took a placebo had a major cardiovascular problem during the study period. Among statin users, 0.9 percent did. In other words, the absolute risk of a serious cardiovascular problem (as opposed to the relative risk) was reduced by less than one percentage point.
"Absolute differences in risk are more clinically important than relative reductions in risk in deciding whether to recommend drug therapy," The New England Journal of Medicine noted in an editorial accompanying a report on the study.
An important indicator of the usefulness of a drug is the "number needed to treat," a measure of how many people needed to take a pill for just one person to be helped. There is disagreement about what Jupiter showed. The New England Journal editorial concluded that treating 120 people for about two years would help one person. The study authors, using different criteria, came up with a figure of 95.
Some researchers think the number is actually much lower. Extrapolating the data to five years, the study's authors concluded that just 25 healthy people would need to take a statin to prevent one serious heart problem.
As a result, some doctors say they will start testing for CRP and will offer statin therapy to patients whose levels are high.
"This was definitely a pretty stunning result," said Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "I, for one, will be checking CRP in more patients. If it's elevated, we will be treating them."
Doctors said one worrisome trend did emerge in the study. In the statin group, 3 percent of the people developed diabetes during the study period, compared with 2.4 percent in the placebo group.
Moreover, because the study was stopped early (so those in the placebo group could begin taking statins for their presumed heart benefits), it did not yield much insight into the drugs' long-term safety. Nor is it clear that the early benefit shown in the statin group would have held up over a longer period or whether other risks might have emerged.
"This study does not indicate that we should be putting statins in the drinking water or fortifying cereal with statins," said Dr. Goldberg, of N.Y.U. "There are millions of people who haven't gone in and even gotten their cholesterol checked, but everybody wants the new thing. They want to believe the new thing will be the total answer."
well@nytimes.com
http://www.nytimes.com/2008/11/18/health/18well.html?8dpc=&pagewanted=print
http://snipurl.com/5segz
Well
A Call for Caution in the Rush to Statins
By TARA PARKER-POPE
Is it time to put cholesterol-lowering statin drugs in every medicine cabinet?
Judging by recent headlines, you might think so. Last week heart researchers reported that millions of healthy people could benefit from taking statins even if they don't have high cholesterol.
Although many doctors hailed the study as a major breakthrough, a closer look at the research suggests that statins (like Crestor, from AstraZeneca, and Lipitor, from Pfizer) are far from magic pills. While they clearly save lives in people with a previous heart attack or other serious heart problems, for an otherwise healthy person the potential benefit remains small.
Many doctors who believe in using statins for heart disease say they needn't be given to healthy patients. Instead, they say, the focus should remain on encouraging healthful behavior and screening for traditional risk factors like high blood pressure and cholesterol.
"Statins have many biological effects that appear to be quite meaningful," said Dr. Valentin Fuster, director of the heart program at Mount Sinai Medical Center in Manhattan and past president of the American Heart Association. "But I don't think the answer is a magic drug to prevent disease. The answer is to change behavior."
Still, the latest study, called Jupiter, is sure to fuel interest in a blood test for something called C-reactive protein, or CRP. The test, which can cost $20 to $50, measures inflammation. Studies have shown that patients with high CRP are at higher risk for heart attack, even if they have normal cholesterol.
The researchers sought out men 50 and older and women 60 and older who had elevated CRP but not high cholesterol. The goal was to determine whether statins could improve their health.
But of nearly 90,000 people who were screened, only 17,802 were selected. That means 80 percent of the recruits were excluded for a variety of reasons — another inflammatory condition like arthritis, medication use, high blood pressure, a history of cancer and so on.
"If you extrapolate that, it means there are not all that many people exactly like those who were studied," said Dr. Nieca Goldberg, director of the women's heart program at New York University Langone Medical Center.
"But I can see a lot of people will be wanting a CRP test," she went on. "My greatest concern is that there will be many people who don't fit the criteria of the study, but based on this they will get blood tests and statin therapy."
And because of the way the Jupiter results were reported, many healthy people are likely to get an exaggerated view of statins' benefits. While the investigators reported an impressive-sounding 50 percent reduction in the risk of serious heart problems among the statin users, in reality everyone in the study had a low risk to begin with.
Only 1.8 percent of the subjects who took a placebo had a major cardiovascular problem during the study period. Among statin users, 0.9 percent did. In other words, the absolute risk of a serious cardiovascular problem (as opposed to the relative risk) was reduced by less than one percentage point.
"Absolute differences in risk are more clinically important than relative reductions in risk in deciding whether to recommend drug therapy," The New England Journal of Medicine noted in an editorial accompanying a report on the study.
An important indicator of the usefulness of a drug is the "number needed to treat," a measure of how many people needed to take a pill for just one person to be helped. There is disagreement about what Jupiter showed. The New England Journal editorial concluded that treating 120 people for about two years would help one person. The study authors, using different criteria, came up with a figure of 95.
Some researchers think the number is actually much lower. Extrapolating the data to five years, the study's authors concluded that just 25 healthy people would need to take a statin to prevent one serious heart problem.
As a result, some doctors say they will start testing for CRP and will offer statin therapy to patients whose levels are high.
"This was definitely a pretty stunning result," said Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "I, for one, will be checking CRP in more patients. If it's elevated, we will be treating them."
Doctors said one worrisome trend did emerge in the study. In the statin group, 3 percent of the people developed diabetes during the study period, compared with 2.4 percent in the placebo group.
Moreover, because the study was stopped early (so those in the placebo group could begin taking statins for their presumed heart benefits), it did not yield much insight into the drugs' long-term safety. Nor is it clear that the early benefit shown in the statin group would have held up over a longer period or whether other risks might have emerged.
"This study does not indicate that we should be putting statins in the drinking water or fortifying cereal with statins," said Dr. Goldberg, of N.Y.U. "There are millions of people who haven't gone in and even gotten their cholesterol checked, but everybody wants the new thing. They want to believe the new thing will be the total answer."
well@nytimes.com
http://www.nytimes.com/2008/11/18/health/18well.html?8dpc=&pagewanted=print
http://snipurl.com/5segz
Sunday, November 16, 2008
More analysis questioning the Crestor Study
While the New York Times, National Public Radio and all the usual uncritical media promoters of pharmaceutical "miracles" are touting the results of using statins to treat people with "normal" cholesterol levels, there are a few analysts carefully shifting through the actual data and context. Merrill Goozner of Gooznews is one of our defenders against hype, here is what he is saying about the Crestor study.
Duncan
November 09, 2008
CRP -- The Next Chapter in Medical Waste?
The latest study on statins and heart disease, which appeared in the New England Journal of Medicine website yesterday and in all the major papers this morning, is worth a second look, not because of what it says about heart disease, which is mildly interesting at best, but because of what it reveals about profit-driven medical research and how it contributes to making the U.S. health care system the most bloated and wasteful in the world.
The randomized clinical trial, code-named Jupiter, involved giving a statin drug or placebo to 17,802 "apparently healthy men and women" (their words) with normal cholesterol but elevated levels of a biomarker for inflammation called C-Reactive Protein (CRP). Did it reduce CRP levels, and did that reduce heart attacks, strokes and, most importantly, sudden death from cardiovascular disease?
The answer to both those questions is yes. But before we go to the data, the first thing you need to know about this trial is that its lead investigator, Paul Ridker of Brigham and Women's Hospital in Boston, owns a patent on the $20 test that measures CRP, and the trial was funded by AstraZeneca, whose $3.45-per-day or $1,250-per-year statin (rosuvastatin or Crestor), was used in the trial. If they can get two million more "apparently healthy men and women" on rosuvastatin, it's an additional $2 billion-plus in sales for AstraZeneca. If they can test 10 million people to find the estimated two million with elevated CRP levels (they had to screen nearly 90,000 people to find the 17,800 eligible for the trial), it's $200 million in test sales, which, if the royalty is only 1 percent, amounts to a hefty $2 million a year in extra income for Dr. Ridker.
I don't mention these conflicts of interest to cast doubt on the validity of the data presented in the NEJM paper. Rather, it puts me, as it should all analyzers of this trial, on guard to see if there were any flaws in its construction, biases in its analysis, or slants in its presentation. The answer to all three of those questions is yes.
First let's take a look at these "apparently" healthy people (men over 50 and women over 60). The median body mass index for the group was 28.3, which means more than half were significantly overweight. Indeed, a third were categorized as obese, which isn't surprising since 41 percent had metabolic syndrome, a suite of conditions that suggests the person is well down the road to developing Type II diabetes.
This profile raises some disturbing questions about the ethical oversight of this trial. Were these trial participants offered counseling about lifestyle changes necessary to avoid developing diabetes, which is recommended for people with metabolic syndrome? The methods section suggests they were only offered the right to participate in the trial, which involved taking a drug that might prevent a heart attack because they had heightened levels of CRP.
The data monitoring committee overseeing the trial stepped in to halt it once it became apparent there would be a statistically significant reduction in cardiovascular events. Where were they when the protocols were being written? Why didn't they step in at the beginning to insist that the at-risk portion of this patient population be offered the best available treatment (diet and exercise counseling) for their condition (metabolic syndrome)?
This oversight becomes even more glaring when we look at one of the more disturbing findings of the trial, noted in an accompanying editorial but "not adjudicated" by the study's endpoint committee. The group on rosuvastatin developed diabetes at a higher rate than the group given a placebo, 3.0 percent versus 2.4 percent, an increase of six-tenths of a percentage point.
Keep the size of that percentage in mind as I now turn to the actual benefits of giving the statin for elevated CRP. While the overall rate of cardiovascular incidents fell from 2.8 percent to 1.6 percent by giving the statin, the number of so-called hard events -- heart attacks and strokes, including those that were fatal -- fell from 1.7 percent in the placebo group to 0.9 percent in the statin group, a drop of eight-tenths of a percentage point.
In other words, for every person who didn't get a serious cardiovascular event, three-quarters of a person got diabetes.
We can look at the benefits another way -- in terms of the number of people who need to be treated to avoid a serious event. In this trial, 120 patients had to be treated for 1.9 years to prevent one serious cardiac event. Remember what rosuvastatin costs? $1,250 a year. That's $285,000 per event prevented just for the statin pills. The physician visits, CRP tests and lab work add additional thousands more. Can you imagine how many heart attacks and strokes could be prevented if that money were targeted at people who are truly at risk of heart disease (the obese, smokers, hypertensives, diabetics) to help them modify their lifestyles and get treatment for their underlying conditions?
There's one other curious element in the trial data. In table 4, Ridker and his fellow authors report that the number of "serious adverse events" in both arms of the trial was almost exactly equal: 15.2 percent in the statin arm versus 15.5 percent in the placebo arm. Presumably, all cardiovascular events (2.8 percent and 1.6 percent, respectively) were included in this total.
On the one hand, I'm not surprised that one in seven trial participants suffered a serious health event during the two years of this trial. The median age of this predominantly overweight group was 66, with some as old as 90.
But what were those other serious events? Alas, the study is silent on this point. I, for one, would like to have seen that data published since the raw number suggests that at the end of the day, both of these groups fared almost exactly the same. In other words, giving a statin to people with elevated CRP did nothing to improve this population's overall health.
So there you have it. A possibly unethical trial with marginal results gets trumpeted in the media as showing "wide benefit" (New York Times). Based on the laudatory quotes coming from the leaders of the American College of Cardiology, this off-label use of statins will quickly find its way into clinical practice guidelines and drug compendia. Within a few years, health care payers will be forking over billions more dollars to the statin drug makers in the name of preventing heart disease.
Meanwhile, our health care outcomes -- including cardiovascular disease -- will still rank somewhere between Romania and Poland. Health care costs will still be rising at twice the rate of overall inflation. And those truly at risk of heart disease still won't be getting the counseling that might save their lives.
Posted by gooznews at November 9, 2008 10:44 PM
http://www.gooznews.com/archives/001243.html
http://snipurl.com/5mq69
Duncan
November 09, 2008
CRP -- The Next Chapter in Medical Waste?
The latest study on statins and heart disease, which appeared in the New England Journal of Medicine website yesterday and in all the major papers this morning, is worth a second look, not because of what it says about heart disease, which is mildly interesting at best, but because of what it reveals about profit-driven medical research and how it contributes to making the U.S. health care system the most bloated and wasteful in the world.
The randomized clinical trial, code-named Jupiter, involved giving a statin drug or placebo to 17,802 "apparently healthy men and women" (their words) with normal cholesterol but elevated levels of a biomarker for inflammation called C-Reactive Protein (CRP). Did it reduce CRP levels, and did that reduce heart attacks, strokes and, most importantly, sudden death from cardiovascular disease?
The answer to both those questions is yes. But before we go to the data, the first thing you need to know about this trial is that its lead investigator, Paul Ridker of Brigham and Women's Hospital in Boston, owns a patent on the $20 test that measures CRP, and the trial was funded by AstraZeneca, whose $3.45-per-day or $1,250-per-year statin (rosuvastatin or Crestor), was used in the trial. If they can get two million more "apparently healthy men and women" on rosuvastatin, it's an additional $2 billion-plus in sales for AstraZeneca. If they can test 10 million people to find the estimated two million with elevated CRP levels (they had to screen nearly 90,000 people to find the 17,800 eligible for the trial), it's $200 million in test sales, which, if the royalty is only 1 percent, amounts to a hefty $2 million a year in extra income for Dr. Ridker.
I don't mention these conflicts of interest to cast doubt on the validity of the data presented in the NEJM paper. Rather, it puts me, as it should all analyzers of this trial, on guard to see if there were any flaws in its construction, biases in its analysis, or slants in its presentation. The answer to all three of those questions is yes.
First let's take a look at these "apparently" healthy people (men over 50 and women over 60). The median body mass index for the group was 28.3, which means more than half were significantly overweight. Indeed, a third were categorized as obese, which isn't surprising since 41 percent had metabolic syndrome, a suite of conditions that suggests the person is well down the road to developing Type II diabetes.
This profile raises some disturbing questions about the ethical oversight of this trial. Were these trial participants offered counseling about lifestyle changes necessary to avoid developing diabetes, which is recommended for people with metabolic syndrome? The methods section suggests they were only offered the right to participate in the trial, which involved taking a drug that might prevent a heart attack because they had heightened levels of CRP.
The data monitoring committee overseeing the trial stepped in to halt it once it became apparent there would be a statistically significant reduction in cardiovascular events. Where were they when the protocols were being written? Why didn't they step in at the beginning to insist that the at-risk portion of this patient population be offered the best available treatment (diet and exercise counseling) for their condition (metabolic syndrome)?
This oversight becomes even more glaring when we look at one of the more disturbing findings of the trial, noted in an accompanying editorial but "not adjudicated" by the study's endpoint committee. The group on rosuvastatin developed diabetes at a higher rate than the group given a placebo, 3.0 percent versus 2.4 percent, an increase of six-tenths of a percentage point.
Keep the size of that percentage in mind as I now turn to the actual benefits of giving the statin for elevated CRP. While the overall rate of cardiovascular incidents fell from 2.8 percent to 1.6 percent by giving the statin, the number of so-called hard events -- heart attacks and strokes, including those that were fatal -- fell from 1.7 percent in the placebo group to 0.9 percent in the statin group, a drop of eight-tenths of a percentage point.
In other words, for every person who didn't get a serious cardiovascular event, three-quarters of a person got diabetes.
We can look at the benefits another way -- in terms of the number of people who need to be treated to avoid a serious event. In this trial, 120 patients had to be treated for 1.9 years to prevent one serious cardiac event. Remember what rosuvastatin costs? $1,250 a year. That's $285,000 per event prevented just for the statin pills. The physician visits, CRP tests and lab work add additional thousands more. Can you imagine how many heart attacks and strokes could be prevented if that money were targeted at people who are truly at risk of heart disease (the obese, smokers, hypertensives, diabetics) to help them modify their lifestyles and get treatment for their underlying conditions?
There's one other curious element in the trial data. In table 4, Ridker and his fellow authors report that the number of "serious adverse events" in both arms of the trial was almost exactly equal: 15.2 percent in the statin arm versus 15.5 percent in the placebo arm. Presumably, all cardiovascular events (2.8 percent and 1.6 percent, respectively) were included in this total.
On the one hand, I'm not surprised that one in seven trial participants suffered a serious health event during the two years of this trial. The median age of this predominantly overweight group was 66, with some as old as 90.
But what were those other serious events? Alas, the study is silent on this point. I, for one, would like to have seen that data published since the raw number suggests that at the end of the day, both of these groups fared almost exactly the same. In other words, giving a statin to people with elevated CRP did nothing to improve this population's overall health.
So there you have it. A possibly unethical trial with marginal results gets trumpeted in the media as showing "wide benefit" (New York Times). Based on the laudatory quotes coming from the leaders of the American College of Cardiology, this off-label use of statins will quickly find its way into clinical practice guidelines and drug compendia. Within a few years, health care payers will be forking over billions more dollars to the statin drug makers in the name of preventing heart disease.
Meanwhile, our health care outcomes -- including cardiovascular disease -- will still rank somewhere between Romania and Poland. Health care costs will still be rising at twice the rate of overall inflation. And those truly at risk of heart disease still won't be getting the counseling that might save their lives.
Posted by gooznews at November 9, 2008 10:44 PM
http://www.gooznews.com/archives/001243.html
http://snipurl.com/5mq69
Thursday, November 13, 2008
Crestor for Healthy People: A Deeper Analysis
Duncan here: If you listened to Morning Edition this morning you
would have heard an absolutely gushing piece of news about the use of
statins (specifically, Crestor) and reduction of heart attacks and
strokes in people with low cholesterol. Now if you just like your
news to be almost completely positive then go here:
http://www.npr.org/templates/story/story.php?storyId=96941206
If you would like a more skeptical view that analyzes the actual
statistics and raises a few questions about taking Crestor at $1200
for the rest of your life, then read below. It is a piece written by
Maggie Mahar author of Money-Driven Medicine and Bull Market as well
as head honcho at the Health Beat Blog.
November 10, 2008
Advice for the “Seemingly Healthy”: Know Your Chances (Part I)
Here we go again. If you haven’t yet heard the news from the American Heart Association meeting that was held in New Orleans yesterday, here is Bloomberg’s report on a medical breakthrough that, some say, will “change the way we practice medicine.”
Bloomberg, Nov. 9: “AstraZeneca Plc's Crestor [a cholesterol-lowering medication] slashed the risk of heart attack, stroke and death by nearly half in people with normal or low cholesterol in a study, potentially opening a way to save the lives of thousands of seemingly healthy people.”
I like that last phrase: “seemingly healthy people.” As we all know, there are no truly healthy people. Even if you think you might be healthy—you’re worried. You know there is probably something wrong with you.
Here, I can’t help but think of “The Last Well Person.” This was the title of an “Occasional Note” that Tennessee physician Clifton Meader wrote for The New England Journal of Medicine in 1994. His fiction was set in the not-too-distant future, and focuses on a 53-year-old professor of freshman algebra at a small college somewhere in the Midwest. He is…you guessed it, the very last healthy American. Using advanced medical screening, physicians have found something wrong with everyone else.
Now medical science is catching up with Meader’s science fiction. It’s beginning to look as if all of should be taking Crestor, or some other cholesterol-lowering drug (a.k.a. a statin) even if we don’t have high cholesterol.
The trial of Crestor reported at the AHA conference yesterday, showed the effect of the drug on patients who did not suffer from high levels of “bad” cholesterol—but did show high levels of a protein called CRP. It turns out that CRP is a marker for inflammation. It is tied to heart risk even in “well” people with no additional symptoms. At the moment, Crestor is approved by U.S. regulators only to lower bad cholesterol. Now, it appears that it also reduces inflammation, and other statins may have the same effect.
As a result, some experts say the study supports broad use of a high-sensitivity CRP test to find people who may be falsely assured by low cholesterol levels that they are protected from trouble. High-sensitivity CRP tests are available just like cholesterol lab tests, and some insurers will cover the cost.
Bloomberg cannot help but gush: if enough people are tested, the news “may help double Crestor's yearly sales to $6.33 billion by 2015, expand the $34 billion market for all cholesterol-lowering medicine and prevent 50,000 heart complications a year, analysts and doctors said. The results suggest an additional 6 million men over age 50 and woman over age 60, the group studied, should take the drugs.
“‘Half of heart attacks and strokes happen among apparently healthy men and women with normal or even low levels of cholesterol,’” observes Paul Ridker, the lead investigator from Harvard Medical School in Boston. “‘We as physicians simply cannot assume our patients are at low risk just because they have low cholesterol.’”
There you go. Just because you look healthy and feel healthy doesn’t mean you are healthy. (Ridker, by the way, holds a "use patent" on CRP testing for heart disease risk. According to NPR, “he says the patent hasn't affected his judgment and that the data speaks for itself.”)
Ridker’s statement reminds me of an ad from New York City’s Memorial Sloan Kettering Hospital that ran in the New York Times :
The early warning signs
of colon cancer
~~~~~~~~~~~~~~~~~~~~~~
You Feel Great
You Have a Healthy Appetite
You’re Only 50.
Drs. Steve Woloshin, Lisa Schwartz and H. Gilbert Welch reproduce this ad at the very beginning of their excellent new book: Know Your Chances: Understanding Health Statistics (How To See Through the Hype in Medical News, Ads and Public Service Announcements).
They use the ad (which looks like a tombstone) to illustrate how health care advertising can leave you “with an exaggerated sense of risk” The ad “says that you need to worry: if you feel well, you may have colon cancer.”
Then there is this message: “Colon Cancer will strike about 150,000 Americans.” Of course, to make sense of this statement, you need to ask “150,000 out of how many?” The answer is 150,000 out of 300 million—or just 0.5 percent of the population.
Putting the Numbers in Context
Know Your Chances is all about putting the numbers describing risks and benefits in context. And this is what Americans need to do when they hear the news stories about Crestor. Should everyone be tested for CRP? If it turns out your CRP levels are high should you start downing Crestor, “just to be safe? “
In an editorial in the current issue of the New England Journal of Medicine, Mark Hlatky, a professor of medicine at Stanford University takes a closer look at the Cresetor study. On the one hand, “The relative risk reductions achieved with the use of statin therapy in [the study] were clearly significant,” Hlatky writes. In other words, when you compare the placebo group to the group that took the medication, you find that the percentage who suffered “hard cardiac events” was indeed cut in half.
But then he goes on to examine “absolute differences” in risk—which involves looking at the actual number of people who benefited, while also considering the possible side effects and other costs of taking the medication. When you put the numbers in that context, you find that the risk/benefit equation looks quite different.
First, while the headlines tell you that the drug slashed the combined number of heart attacks , strokes and deaths in half—what that really means is that the number who suffered one of these “adverse events” was pared from 1.8% (157 out of 8901 patients who received a placebo) to .9% (83 of the 8901 patients who took Crestor).
Hlatky sums up the medical miracle: “120 participants were treated for 1.9 years to prevent one event.” 120—that’s the number of subject researchers needed to treat in order to spare one person a stroke or a heart attack. (Note, not all adverse events led to death.) For more on “number needed to treat,” to find one patient who benefits, see Niko’s excellent post here on Health Beat.
Here is the question you have to ask yourself: would you want to take this drug for the rest of your life based on the possibility that you might be the 1 out of 120 who benefits? It depends.
First, it depends on how you feel about the side effects. The patients who took Crestor showed “significantly higher glycated hemoglobin levels and incidence of diabetes,” Hlatky points out (3.0%, vs. 2.4% in the placebo group). Translation: There were 270 cases of diabetes among patients who took Crestor compared with 216 among those on placebo.
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Friday, October 17, 2008
Pfizer Accused of Data Manipulation
Experts Conclude Pfizer Manipulated Studies
By STEPHANIE SAUL
The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.
Pfizer's tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, "spinning" negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs' lawyers.
One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out "a publication strategy meant to convince physicians of Neurontin's effectiveness and misrepresent or suppress negative findings." CLICK A LINK FOR MORE
http://www.nytimes.com/2008/10/08/health/research/08drug.html?partner=rssnyt&emc=rss&pagewanted=print
http://snipurl.com/4g7ug
By STEPHANIE SAUL
The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.
Pfizer's tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, "spinning" negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs' lawyers.
One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out "a publication strategy meant to convince physicians of Neurontin's effectiveness and misrepresent or suppress negative findings." CLICK A LINK FOR MORE
http://www.nytimes.com/2008/10/08/health/research/08drug.html?partner=rssnyt&emc=rss&pagewanted=print
http://snipurl.com/4g7ug
Thursday, October 16, 2008
Lies, damn lies and statistics
Another article that explores how people including the professionals can be confused by statistics.
Duncan
Drug Claims Often Misleading
Even Doctors Are Confused by Medical Statistics, Study Shows
By LEE DYE
Oct. 15, 2008—
If you were told a drug you are taking has been found to increase the risks of death by 100 percent, would you stop taking it? Of course. But does that statement really mean you are much more likely to die if you keep taking the drug? Absolutely not.
Statistics like that, touting drugs and their possible side effects, can be so misleading that even doctors frequently misunderstand them, according to a major international study that brands many health care professionals as "statistical illiterates."
The report, published in the current issue of Psychological Science in the Public Interest, cites numerous instances of grossly overstated benefits, or adverse effects, of drugs and medical procedures, which, in some cases, has had devastating results.
The researchers accuse drug companies of knowingly using misleading statistics to promote their products because a "big number" can lead to a big headline and lots of sales. And a well-meaning institution might also seek a big number to warn of possible dangerous side effects of a drug, even if that number implies a much greater risk than actually exists.
Statistical skullduggery strikes at just about every level, from professional medical journals to health care workers to medical writers who convey the bad numbers that frequently come from news releases promulgated by some of the leading research institutions in the world, the report says.
"Many doctors, patients, journalists, and politicians alike do not understand what health statistics mean," according to the study, authored by two medical professors at Dartmouth Medical School, Steven Woloshin and Lisa M. Schwartz, and their collaborators, psychologists Gerd Gigerenzer, Wolfgang Gaissmaier and Elke Kurz-Milcke of the Max Planck Institute for Human Development in Berlin.
One of many cases they cite had tragic consequences. In 1995, the United Kingdom Committee on Safety of Medicines issued a warning that "third-generation oral contraceptive pills increased the risk of potentially life-threatening blood clots in the legs or lungs twofold -- that is, by 100 percent," the report states. It was a big number, and it got a lot of attention, but it was very misleading.
"This information was passed on in 'Dear Doctor' letters to 190,000 general practitioners, pharmacists, and directors of public health and was presented in an emergency announcement to the media," the report continues. "The news caused great anxiety, and distressed women stopped taking the pill, which led to unwanted pregnancies and abortions."
The scare was blamed for 13,000 abortions the following year, many involving teen pregnancies.
But who can argue with 100 percent? The report adds:
"The studies on which the warning was based had shown that, of every 7,000 women who took the earlier, second-generation oral contraceptive pills, about one had a thrombosis; this number increased to two among women who took third-generation pills. The absolute risk increase was only one in 7,000, whereas the relative increase (among women who developed blood clots) was indeed 100 percent."
That's right. An increase from one to two, but that's out of 7,000.
That omission of key information, namely the numbers, is common to many -- perhaps most -- claims about drugs and medical interventions, regardless of the source of the claims, according to the study. It's routine in drug advertisements. It's common in announcements from many institutions that have found a dangerous side effect and want to be sure they get your attention.
But it's wrong.
There are several other ways that statistics can be very misleading, like overstating survival rates, or implying that in all cases early screening can lead to early detection and more successful treatment, the researchers contend.
In his unsuccessful attempt to win his party's nomination for president, Rudy Giuliani said in a campaign advertisement: "I had prostate cancer, 5, 6 years ago. My chance of surviving prostate cancer -- and thank God, I was cured of it -- in the United States? Eighty-two percent. My chance of surviving prostate cancer in England? Only 44 percent under socialized medicine."
That is flat out wrong, according to the researchers. "Giuliani's numbers are meaningless for making comparisons across groups of people that differ dramatically in how the diagnosis is made," the report states.
Giuliani's claim that men are nearly twice as likely to survive in the United States as in England is based on a five-year survival rate after detection. In a 2000 study, 49 British men per 100,000 were diagnosed with prostate cancer, of which 28 died within five years, about 44 percent. But screening for prostate cancer is different in England than in the United States. This country relies heavily on a prostate-specific antigens (PSA) test, which can sometimes detect cancer earlier. But the test is not widely used in England. Thus, the detection, and the five-year survival rate, spans a different time in the lives of patients in the two countries.
To illustrate the point, the report turns to a hypothetical situation:
"Imagine a group of prostate cancer patients currently diagnosed at age 67, all of whom die at age 70. Each survived only three years, so the five-year survival of this group is 0 percent. Now imagine that the same group is diagnosed with prostate cancer by PSA tests earlier, at age 60, but they all still die at age 70."
If the patients in the second group lived to the age of 65, their five-year survival rate would be 100 percent, although they all died by age 70.
"Even though the survival rate has changed dramatically, nothing has changed about the time of death," the report notes.
"Are American men half as likely to die from prostate cancer as British men are?" the study continues. "The answer is no; the risk is about the same: About 26 prostate cancer deaths per 100,000 American men versus 27 per 100,000 in Britain."
Not to worry, the doctor always knows best, right? Not necessarily, according to the report.
In several studies, physicians were asked if they really understood what the widely known 25 percent risk reduction by mammography screening really means. If 1,000 women are tested, how many fewer will die of breast cancer?
The answers were all over the map, ranging from one out of 1,000 to 750 out of 1,000. Fortunately, most gave the correct answer, the researchers say, which is one. One more survivor will be added to the list, and that's 25 percent of the total number of survivors. But even after the answer was revealed, one physician insisted it should be 250.
Copyright © 2008 ABC News Internet Ventures
http://abcnews.go.com/print?id=6034371
http://snipurl.com/4f14k
Duncan
Drug Claims Often Misleading
Even Doctors Are Confused by Medical Statistics, Study Shows
By LEE DYE
Oct. 15, 2008—
If you were told a drug you are taking has been found to increase the risks of death by 100 percent, would you stop taking it? Of course. But does that statement really mean you are much more likely to die if you keep taking the drug? Absolutely not.
Statistics like that, touting drugs and their possible side effects, can be so misleading that even doctors frequently misunderstand them, according to a major international study that brands many health care professionals as "statistical illiterates."
The report, published in the current issue of Psychological Science in the Public Interest, cites numerous instances of grossly overstated benefits, or adverse effects, of drugs and medical procedures, which, in some cases, has had devastating results.
The researchers accuse drug companies of knowingly using misleading statistics to promote their products because a "big number" can lead to a big headline and lots of sales. And a well-meaning institution might also seek a big number to warn of possible dangerous side effects of a drug, even if that number implies a much greater risk than actually exists.
Statistical skullduggery strikes at just about every level, from professional medical journals to health care workers to medical writers who convey the bad numbers that frequently come from news releases promulgated by some of the leading research institutions in the world, the report says.
"Many doctors, patients, journalists, and politicians alike do not understand what health statistics mean," according to the study, authored by two medical professors at Dartmouth Medical School, Steven Woloshin and Lisa M. Schwartz, and their collaborators, psychologists Gerd Gigerenzer, Wolfgang Gaissmaier and Elke Kurz-Milcke of the Max Planck Institute for Human Development in Berlin.
One of many cases they cite had tragic consequences. In 1995, the United Kingdom Committee on Safety of Medicines issued a warning that "third-generation oral contraceptive pills increased the risk of potentially life-threatening blood clots in the legs or lungs twofold -- that is, by 100 percent," the report states. It was a big number, and it got a lot of attention, but it was very misleading.
"This information was passed on in 'Dear Doctor' letters to 190,000 general practitioners, pharmacists, and directors of public health and was presented in an emergency announcement to the media," the report continues. "The news caused great anxiety, and distressed women stopped taking the pill, which led to unwanted pregnancies and abortions."
The scare was blamed for 13,000 abortions the following year, many involving teen pregnancies.
But who can argue with 100 percent? The report adds:
"The studies on which the warning was based had shown that, of every 7,000 women who took the earlier, second-generation oral contraceptive pills, about one had a thrombosis; this number increased to two among women who took third-generation pills. The absolute risk increase was only one in 7,000, whereas the relative increase (among women who developed blood clots) was indeed 100 percent."
That's right. An increase from one to two, but that's out of 7,000.
That omission of key information, namely the numbers, is common to many -- perhaps most -- claims about drugs and medical interventions, regardless of the source of the claims, according to the study. It's routine in drug advertisements. It's common in announcements from many institutions that have found a dangerous side effect and want to be sure they get your attention.
But it's wrong.
There are several other ways that statistics can be very misleading, like overstating survival rates, or implying that in all cases early screening can lead to early detection and more successful treatment, the researchers contend.
In his unsuccessful attempt to win his party's nomination for president, Rudy Giuliani said in a campaign advertisement: "I had prostate cancer, 5, 6 years ago. My chance of surviving prostate cancer -- and thank God, I was cured of it -- in the United States? Eighty-two percent. My chance of surviving prostate cancer in England? Only 44 percent under socialized medicine."
That is flat out wrong, according to the researchers. "Giuliani's numbers are meaningless for making comparisons across groups of people that differ dramatically in how the diagnosis is made," the report states.
Giuliani's claim that men are nearly twice as likely to survive in the United States as in England is based on a five-year survival rate after detection. In a 2000 study, 49 British men per 100,000 were diagnosed with prostate cancer, of which 28 died within five years, about 44 percent. But screening for prostate cancer is different in England than in the United States. This country relies heavily on a prostate-specific antigens (PSA) test, which can sometimes detect cancer earlier. But the test is not widely used in England. Thus, the detection, and the five-year survival rate, spans a different time in the lives of patients in the two countries.
To illustrate the point, the report turns to a hypothetical situation:
"Imagine a group of prostate cancer patients currently diagnosed at age 67, all of whom die at age 70. Each survived only three years, so the five-year survival of this group is 0 percent. Now imagine that the same group is diagnosed with prostate cancer by PSA tests earlier, at age 60, but they all still die at age 70."
If the patients in the second group lived to the age of 65, their five-year survival rate would be 100 percent, although they all died by age 70.
"Even though the survival rate has changed dramatically, nothing has changed about the time of death," the report notes.
"Are American men half as likely to die from prostate cancer as British men are?" the study continues. "The answer is no; the risk is about the same: About 26 prostate cancer deaths per 100,000 American men versus 27 per 100,000 in Britain."
Not to worry, the doctor always knows best, right? Not necessarily, according to the report.
In several studies, physicians were asked if they really understood what the widely known 25 percent risk reduction by mammography screening really means. If 1,000 women are tested, how many fewer will die of breast cancer?
The answers were all over the map, ranging from one out of 1,000 to 750 out of 1,000. Fortunately, most gave the correct answer, the researchers say, which is one. One more survivor will be added to the list, and that's 25 percent of the total number of survivors. But even after the answer was revealed, one physician insisted it should be 250.
Copyright © 2008 ABC News Internet Ventures
http://abcnews.go.com/print?id=6034371
http://snipurl.com/4f14k
Wednesday, September 17, 2008
Cure! We Don't Need No Stinking Cure!!
This is from the New Yorker and can be found with many others at their cartoon site: http://www.cartoonbank.com/
Here is a comment about the cartoon from John Mack at http://pharmamkting.blogspot.com/
"Are cures for high blood pressure, diabetes, Alzheimers, insomnia, etc. going to come from the drug industry? Not unless you believe that taking a pill every day for the rest of your life is a cure. What I'd like to have is a course of treatment for high blood pressure that involves two weeks of drug therapy and then no more high blood pressure for years or the rest of my life! You know, just like some of the first drugs ever developed: antibiotics!"
Why Free Samples Aren't So Free
This was published at the PharmaTimes site:
Free drug samples "can cost patients more:" US study
16 September 2008
Free drug samples which physicians receive from pharmaceutical manufacturers and then hand on to their patients may actually prove more expensive in the long term for people without health insurance, a new study finds.
The availability of free samples, which are only available for brand-name drugs, greatly impacts on whether an uninsured patient is given a prescription for a generic or a brand-name drug, it says......
........"Physicians and medical organizations need to ask themselves if samples are doing more harm than good," commented Dr Miller. "While doctors might intend to help someone by handing them a free sample, in the long run, it could cost them more. And removing samples from a practice can help doctors focus on which medication is best for a patient, rather than which medication happens to be available for free."
For the whole story click the links:
http://www.pharmatimes.com/WorldNews/article.aspx?id=14353&src=EWorldNews
http://snipurl.com/3r539
Free drug samples "can cost patients more:" US study
16 September 2008
Free drug samples which physicians receive from pharmaceutical manufacturers and then hand on to their patients may actually prove more expensive in the long term for people without health insurance, a new study finds.
The availability of free samples, which are only available for brand-name drugs, greatly impacts on whether an uninsured patient is given a prescription for a generic or a brand-name drug, it says......
........"Physicians and medical organizations need to ask themselves if samples are doing more harm than good," commented Dr Miller. "While doctors might intend to help someone by handing them a free sample, in the long run, it could cost them more. And removing samples from a practice can help doctors focus on which medication is best for a patient, rather than which medication happens to be available for free."
For the whole story click the links:
http://www.pharmatimes.com/WorldNews/article.aspx?id=14353&src=EWorldNews
http://snipurl.com/3r539
Thursday, September 11, 2008
UT Researcher Added to Suspicious Behavior List
Here is an item from the Wall Street Journal about another researcher at a major university who did not disclosure significant payments from a pharma company:
Karen Wagner, a child psychiatrist at the University of Texas Medical Branch, is the latest academic psychiatrist to be criticized by Sen. Chuck Grassley (R-Iowa) for failing to fully disclose drug industry ties.
Grassley said in a letter that Wagner didn't disclose more than $150,000 in consulting and speaking fees she received from GlaxoSmithKline in recent years, the WSJ reports. Wagner worked on an NIH study of the treatment of teenage depression that included Glaxo's antidepressant Paxil. Wagner didn't respond to the WSJ's requests for comment. The university said it would look into the alleged discrepancies.
CLICK LINK FOR MUCH MORE
http://blogs.wsj.com/health/2008/09/11/sen-grassley-blasts-psychiatrist-for-failure-to-disclose-industry-funding/
http://snipurl.com/3pde2
Karen Wagner, a child psychiatrist at the University of Texas Medical Branch, is the latest academic psychiatrist to be criticized by Sen. Chuck Grassley (R-Iowa) for failing to fully disclose drug industry ties.
Grassley said in a letter that Wagner didn't disclose more than $150,000 in consulting and speaking fees she received from GlaxoSmithKline in recent years, the WSJ reports. Wagner worked on an NIH study of the treatment of teenage depression that included Glaxo's antidepressant Paxil. Wagner didn't respond to the WSJ's requests for comment. The university said it would look into the alleged discrepancies.
CLICK LINK FOR MUCH MORE
http://blogs.wsj.com/health/2008/09/11/sen-grassley-blasts-psychiatrist-for-failure-to-disclose-industry-funding/
http://snipurl.com/3pde2
Wednesday, August 27, 2008
And Then There Are Just Mistakes. Yikes!!
Sometimes the problem is not side effects, poor research, or slick marketing; sometimes simple but deadly mistakes are made in the hustle and bustle of hospital life. Here is an intro with link, to a piece from Forbes on Hospital Risks.
Duncan
Scariest Hospital Risks
Matthew Herper and Melanie Lindner 08.25.08, 4:15 PM ET
Hospitals manufacture miracles by the millions. They can also be hazardous to your health.
According to The Institute of Medicine, a non-profit organization chartered by the U.S. National Academy of Sciences, at least 1.5 million Americans fall prey to hospital error every year.
"Errors will happen anytime you take a complex system and put human beings inside of it," says Dr. Brent James, vice president of medical research and executive director of Salt Lake City's Intermountain Institute for Health Care Delivery Research. "The notion that you can train doctors to completely avoid mistakes is just false."
The mistakes aren't exactly minor, either. Between 40,000 and 100,000 people die every year because of shoddy handiwork, including surgical mishaps and drug mix-ups. One big problem: Hospital patients may get the wrong drug one time out of five, according to a study by Auburn University. The death toll from mistakes is at least as bad as that from car accidents or breast cancer, and maybe as bad as that from strokes.....follow the link for more
http://www.forbes.com/2008/08/25/hospital-risk-pneumonia-ent-manage-cx_mh_0825riskhospital_print.html
http://snipurl.com/3ke6b
Duncan
Scariest Hospital Risks
Matthew Herper and Melanie Lindner 08.25.08, 4:15 PM ET
Hospitals manufacture miracles by the millions. They can also be hazardous to your health.
According to The Institute of Medicine, a non-profit organization chartered by the U.S. National Academy of Sciences, at least 1.5 million Americans fall prey to hospital error every year.
"Errors will happen anytime you take a complex system and put human beings inside of it," says Dr. Brent James, vice president of medical research and executive director of Salt Lake City's Intermountain Institute for Health Care Delivery Research. "The notion that you can train doctors to completely avoid mistakes is just false."
The mistakes aren't exactly minor, either. Between 40,000 and 100,000 people die every year because of shoddy handiwork, including surgical mishaps and drug mix-ups. One big problem: Hospital patients may get the wrong drug one time out of five, according to a study by Auburn University. The death toll from mistakes is at least as bad as that from car accidents or breast cancer, and maybe as bad as that from strokes.....follow the link for more
http://www.forbes.com/2008/08/25/hospital-risk-pneumonia-ent-manage-cx_mh_0825riskhospital_print.html
http://snipurl.com/3ke6b
Tuesday, August 26, 2008
Doctors, Marketing, and Money = Messy
Here is a item from CNN on physicians, money, marketing and ties to pharmaceutical and medical device companies. We, of course, would like to believe that all physicians are objective and only interested in our welfare. I wish it were true but sometimes........... Duncan
ATLANTA, Georgia (CNN) -- Linda Lewis says that when she had back surgery two years ago, her surgeon didn't do what was best for her health; he did was best for his bank account.
If Linda Lewis had known of her surgeon's financial ties to a device maker, she'd have sought a second opinion.
If Linda Lewis had known of her surgeon's financial ties to a device maker, she'd have sought a second opinion.
Lewis, a graduate student who lives in Sherman Oaks, California, says Dr. John Regan, a surgeon in Beverly Hills, put in an artificial disc to help relieve her lower back pain.
"He said my back would be better than ever," said Lewis, 45. "I'm thinking, 'Wow, disc replacement is the best thing since sliced bread.' "
But after the surgery, Lewis says, she ended up in debilitating pain, could walk only with the assistance of a walker and had to have a second procedure to correct the first one.
"I couldn't take enough drugs for the pain," she said. "Having that surgery was the worst decision of my life."
Lewis said she was "livid" when she later found out that Regan had financial ties to the company that makes the disc, saying she believes that those ties prompted Regan to recommend the disc over other treatment options.
In an e-mail to CNN, Regan's office manager said he "is not available for comment."
How likely is it that your doctor has a tie to a company that makes drugs or devices? Very likely, according to Dr. Robert Steinbrook, who wrote an article on doctor/industry ties this month in the New England Journal of Medicine. Video Watch more on medical marketing and doctors »
"Most physicians in the United States have financial relationships with industry, ranging from the acceptance of meals to the receipt of large sums of money for consulting, speaking, or conducting research," he wrote.
For example, two physicians made more than $8 million each from Dupuy Orthopaedics Inc., which lists the payments on its Web site.
"Consumers should absolutely know where their doctor is coming from," said Steven Findlay, a health care analyst at Consumers Union. "Doctors think they won't be influenced by these financial relationships, but the research shows that they are.".........click on the link for the rest.
Don't become a victim of medical marketing - CNN.com
ATLANTA, Georgia (CNN) -- Linda Lewis says that when she had back surgery two years ago, her surgeon didn't do what was best for her health; he did was best for his bank account.
If Linda Lewis had known of her surgeon's financial ties to a device maker, she'd have sought a second opinion.
If Linda Lewis had known of her surgeon's financial ties to a device maker, she'd have sought a second opinion.
Lewis, a graduate student who lives in Sherman Oaks, California, says Dr. John Regan, a surgeon in Beverly Hills, put in an artificial disc to help relieve her lower back pain.
"He said my back would be better than ever," said Lewis, 45. "I'm thinking, 'Wow, disc replacement is the best thing since sliced bread.' "
But after the surgery, Lewis says, she ended up in debilitating pain, could walk only with the assistance of a walker and had to have a second procedure to correct the first one.
"I couldn't take enough drugs for the pain," she said. "Having that surgery was the worst decision of my life."
Lewis said she was "livid" when she later found out that Regan had financial ties to the company that makes the disc, saying she believes that those ties prompted Regan to recommend the disc over other treatment options.
In an e-mail to CNN, Regan's office manager said he "is not available for comment."
How likely is it that your doctor has a tie to a company that makes drugs or devices? Very likely, according to Dr. Robert Steinbrook, who wrote an article on doctor/industry ties this month in the New England Journal of Medicine. Video Watch more on medical marketing and doctors »
"Most physicians in the United States have financial relationships with industry, ranging from the acceptance of meals to the receipt of large sums of money for consulting, speaking, or conducting research," he wrote.
For example, two physicians made more than $8 million each from Dupuy Orthopaedics Inc., which lists the payments on its Web site.
"Consumers should absolutely know where their doctor is coming from," said Steven Findlay, a health care analyst at Consumers Union. "Doctors think they won't be influenced by these financial relationships, but the research shows that they are.".........click on the link for the rest.
Don't become a victim of medical marketing - CNN.com
Thursday, August 21, 2008
A No-good Rotten Pharma Joke
The devil visited a pharma rep's home office and made him an offer. "I can arrange some things for you, " the devil said. "I'll increase your income five-fold. Your cluster mates will love you; your docs will respect you; you'll have four months of vacation each year and live to be a hundred. All I require in return is that your wife's soul, your children's souls, and their children's souls rot in hell for eternity."
The rep thought for a moment. "What's the catch?" he asked.
(a tip of the hat to John at http://pharmamkting.blogspot.com/, this was originally about only a Merck sales rep)
The rep thought for a moment. "What's the catch?" he asked.
(a tip of the hat to John at http://pharmamkting.blogspot.com/, this was originally about only a Merck sales rep)
HPV Vaccines Questioned
Here in Texas, Governer Rick Perry tried by fiat to make the HPV virus mandatory but such a howl of protest arose that he backed down.
As frequently happens, now that there has been some time to consider whether taking such a vaccine is really a benefit, there are some real doubts arising.
Here is part of an article in the New York Times to addresses some of the questions.
Duncan
Researchers Question Wide Use of HPV Vaccines
By ELISABETH ROSENTHAL
Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week's New England Journal of Medicine conclude.
Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer.
The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.
http://www.nytimes.com/2008/08/21/health/21vaccine.html?_r=2&adxnnl=1&oref=slogin&ref=health&adxnnlx=1219335271-x9SgZFwVczlgNJxDckKSUQ&pagewanted=print
Click this link for the rest of the story:
http://snipurl.com/3ig07
As frequently happens, now that there has been some time to consider whether taking such a vaccine is really a benefit, there are some real doubts arising.
Here is part of an article in the New York Times to addresses some of the questions.
Duncan
Researchers Question Wide Use of HPV Vaccines
By ELISABETH ROSENTHAL
Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week's New England Journal of Medicine conclude.
Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer.
The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.
http://www.nytimes.com/2008/08/21/health/21vaccine.html?_r=2&adxnnl=1&oref=slogin&ref=health&adxnnlx=1219335271-x9SgZFwVczlgNJxDckKSUQ&pagewanted=print
Click this link for the rest of the story:
http://snipurl.com/3ig07
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