"When many cures are offered for a disease, it means the disease is not curable" -Anton Chekhov
''Once you tell people there's a cure for something, the more likely they are to pressure doctors to prescribe it.'' -Robert Ehrlich, drug advertising executive.
"Opinions are like sphincters, everyone has one." - Chris Rangel
Did I tell you I'm being sued for $160,000? A big lummox of an Irishman, while drunk, fell downstairs after beating up his wife- so much so that she walked out on him after the accident and started divorce proceedings against him. He finally died as a result of another fall, on top of the first one and after being twice in the hospital, drunk as hell in between and generally out of control- he weighed 250 pounds if he weighed an ounce. So she is suing me because I neglected him! And me after sitting between the two of them through it all. Just because he didn't get double indemnity because when he fell he was drunk and I said he was drunk. So if the case comes up and I have to start over again on a nickel - won't it be a joke, it will. I'm insured for $25,000, but what's that? They say I have nothing to fear- it all happened over three years ago now - but at times it disturbs me. Life is sour enough without that.
It was ever thus.
It was even worse in earlier times, on the frontier. Consider the case of Mary Rowland, a physician in Kansas at the turn of the twentieth century. In her memoir, As Long As Life: The Memoirs of a Frontier Woman Doctor, she describes what happened to her when a mother blamed her for the death of her children from diphtheria. (The doctor's husband had just been murdered, leaving her the sole caretaker of an infant daughter. She was understandably reluctant to nurse children with an infection that she would risk taking home to her own infant. And yet, somehow, it still seems as if she betrayed the traditional professional ethic):
When I arrived to make an examination of the children, I found them suffering. I was afraid to take care of them because of the intimate care I was giving to my baby, therefore I told them that I would send the county doctor with antitoxin. The county doctor put off going for two days and, when he finally went, forgot to take the antitoxin. It was another day before the children received it and they both died.
The distracted mother blamed me for their deaths. She became unbalanced and came to my house where she raved and upbraided me for not taking care of her little girls. She said that I had saved the children of her neighbor, but had refused to treat hers. Now they were dead. Suddenly, she drew out a butcher knife and said she was going to kill me, but her husband and another man finally subdued her. posted by Sydney on
11/26/2004 01:49:00 PM
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GE, Bringing Good Things to Themselves: General Electric's medical malpractice insurance branch, Medical Protective, has given ammunition to opponents of tort reform by claiming that tort reform doesn't work:
One of the nation's largest medical-malpractice insurance companies told regulators that recently enacted caps on noneconomic damages in Texas would save it little money.
...Medical Protective's filing was made public by the Foundation for Taxpayer & Consumer Rights, a Santa Monica, Calif., consumer group that has opposed such caps. The foundation has also opposed rate increases by Medical Protective and others in the state of California.
"When the largest malpractice insurer in the nation tells a regulator that caps on damages don't work, every legislator, regulator and voter in the nation should listen," said the foundation's executive director, Douglas Heller.
The claims was part of a document they submitted to the Texas Department of Insurance to request a rate increase. Spokesmen for the company are now backpedalling, saying their remarkes were taken out of context, and that tort reform and caps are necessary to rein in premium rates. The damage has been done, however. You can't have your cake and eat it, too.
Which is exactly what Medical Protective and GE are trying to do. I have no knowledge of what goes on inside the Ge boardroom, but the company acts in every way like a company eager to get rid of its malpractice insurance branch. Being a nationwide company hasn't helped them in this era of litigation. They've been raising their rates across the board, dropping doctors after two claims, no matter how frivolous, and leaving markets all together. It's almost as if they're trying to plump up the bottom line as much as possible to make themselves attractive to a buyer. They may be the largest medical malpractice insurer, but they aren't the most committed.
Medical Protective has been raising its medical liability insurance rates nationwide. The company filed for a 19 percent rate increase here in Texas to be effective June 1, 2004. I did not feel that this increase took into account, among other things, the full effect of the reforms enacted by Proposition 12, which was passed by Texas voters last year. While the increase Medical Protective was seeking is lower than what they are implementing in other states, I do not feel it is justified.
The Texas market is strong and getting stronger. Ten (10) new carriers have recently taken concrete steps to enter the Texas marketplace and many more have indicated an interest in doing business in Texas. Rates have stabilized and competition is returning. This action by Medical Protective in no way reflects on the viability of the medical liability market in Texas.
GE Medical Protective took their case to court (apparently without irony) and persuaded a judge to let them raise rates:
The Texas Department of Insurance has tried since May to block G.E. Medical Protective Co.'s rate increase, which regulators have said is excessive.
The fight between regulators and the company, also called MedPro, has been a closely watched test for the effectiveness of 2003 legislation designed to lower soaring insurance costs for doctors by reducing the number of medical malpractice lawsuits.
An administrative judge issued a proposed decision, finding that there is enough competition in the medical malpractice market to allow MedPro to set its own rates.
Jim Hurley, a spokesman for the Insurance Department, said the department disagrees with the ruling and will be filing exceptions to the judge's findings. A final decision by the judge is expected in January.
That decision will go to the insurance commissioner, who can accept or reject it.
Bet he rejects it.
UPDATE: While visiting with family over the Thanksgiving weekend, the topic of medical malpractice premium costs and GE's insurance line came up. One of my relatives pointed out that GE was hit particularly hard on 9/11. As GE's CEO put it:
I had an airplane with my engines hit a building I insured, covered by a network I owned – and I still [expect to] increase earnings by 11 per cent.
Sometimes, it's better to have an insurance company that isn't so widely diversified.
posted by Sydney on
11/26/2004 01:30:00 PM
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The Next Flu: This year's flu season has yet to begin, but world flu experts are worried that a future flu will be deadly and widespread:
Every country in the world must come up urgently with a plan to deal with an inevitable influenza pandemic likely to be triggered by the bird flu virus that hit Asia this year, a top global health expert said on Friday.
....The H5N1 virus, which has already killed 20 Vietnamese and 12 Thais, arrived in Asia about a year ago, probably spread by migrating birds, especially wild fowl heading to warmer climes at the onset of the northern winter.
Governments have slaughtered tens of millions of poultry in a bid to eradicate it but WHO experts say it is now probably a permanent fixture.
The wild birds, which can carry the virus without falling ill, are flying south through Asia to escape the northern winter and, in an alarming development, domesticated ducks are showing they too can have the virus without showing it, Omi said.
Experts say a pandemic will emerge from an animal, most probably a pig, which can harbor both flu viruses that affect humans and the avian flu variety. The two would mate and produce a virus to which people have no immunity, they say.
Here's thanking every pilgrim soul who made their doubts remove and crossed the sea to these shores. posted by Sydney on
11/25/2004 01:30:00 AM
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Thanksgiving Eve and Early Morn: I think the day before Thanksgiving is just about my favorite day of the year. Everyone is in a good mood the day before Thanksgiving, much more so than the day before Christmas. My office hours always go smoothly the day before Thanksgiving. No one comes in with a hidden agenda, unlike Christmas Eve, when invariably someone comes in ostensibly for a sore throat but really because they're feeling suicidal. Maybe it's because Thanksgiving is always on a Thursday, giving it the singular joy of making a Wednesday feel as if it's a Friday. Or maybe it's because it's free of the gift-giving burden and angst that goes with Christmas. But most likely, it's because Thanksgiving is a holiday that we can all enjoy, regardless of religious belief (or lack of belief.) Its roots might lie in the thanks and praise to God of a small religious sect, but most of us really think of the holiday as a celebration of our immigrant roots, even if we don't descend from the original Pilgrims.
We are not only the Protestants who left England to escape the Catholics, but the Catholics who left England to escape the Protestants. We are the Europeans who left the Old World to escape taxes, monarchy, and Napoleon. We are the slaves brought against their will, and the indentured servants hoping for a better life. We are the Irish escaping the English, the Italians escaping anarchy, and the Jews escaping everyone. And that's just my family. posted by Sydney on
11/25/2004 01:27:00 AM
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Pumpkin Pie: I'm sitting here waiting for the pumpkin pie to finish baking so I can go to bed. Got a late start. Just as well. I'm on also on call and I've been getting paged every ten to fifteen minutes. If I were trying to sleep, I'd be really frustrated by now. But instead, I've been reading my father-in-law's United States of America War Office Cook Book, circa 1950. (Also called TM 10-412-AFM 146-3)
Here's the recipe for pumpkin pie:
6 1/2 pounds brown sugar
1 1/2 ounces cinnamon
1/2 ounce mace
1 1/2 ounces salt
30 eggs, slightly beaten
Six 14.5 ounce cans evaporated milk
3 quarts water
Two No. 10 cans pumpkin (the preface helpfully explains that a No. 10 can is a little over 6 pounds, depending on its contents)
1. Mix sugar, cinnamon, mace, and salt together.
2. Add beaten egg; mix thoroughly.
3. Mix milk and water; heat. Add hot milk and pumpkin to egg mixture; mix thoroughly
4. Place unbaked pie shells in oven. Pour one quart of filling into each pie shell.
5. Bake in hot oven (400 to 425 degrees Fahrenheit) about 15 minutes. Reduce heat and continue baking 15 minutes or until center of pie filling has risen level with crust. Remove immediately from oven.
A girl of 15 has survived rabies without vaccination. Jeanna Geise was given a combination of drugs which cured her rabies.
Her doctors induced a coma in order to stop the spread of the infection. They then started administering a cocktail of drugs. A spinal tap after treatment showed that her immune system was effectively fighting off the virus. She was kept in coma for a week.
Dr Rodnay Willoughty, Wisconsin's Children's Hospital, said "No one had really done this before, even in animals. None of the drugs are fancy. If this works it can be done in a lot of countries."
...Jeanna had been bitten by a rabid bat while attending a church service. Unfortunately, she did not get treatment immediately. About five weeks later she started showing symptoms of rabies - it had attacked her nervous system.
..Rabies is a fairly big killer - about 100 people a day die from it (worldwide).
Knowing that rabies, after onset of the infection, is virtually 100% fatal, doctors decided (with parent's consent) to try the experimental treatment within four hours of receiving her.
Don't look for this to take the place of rabies vaccination, but it might provide hope for those who for some reason fail to get the vaccine after being bitten. (And remember, bats are assumed rabid until proven otherwise.) posted by Sydney on
11/24/2004 08:11:00 AM
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A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings prom-ised by the U.S. Food and Drug Administration more than a year ago.
Each bottle of the drug, amiodarone -- sold under the brand names Cordarone and Pacerone as well several generics -- is supposed to include a new advisory that warns of its risks and symptoms of fatal side effects and explains how the medication is supposed to be used. But the advisory, planned since October 2003, remains in draft form, bouncing back and forth between the FDA and the drug maker assigned to write it.
Why is it left to the manufacturer to write the warning? Shouldn't the FDA do it?
Amiodarone is a fairly toxic medication. It's approved for treating ventricular arrhythmias, which can be deadly. But in the late 1990's it gained some favor as a treatment for recalcitrant atrial fibrillation, a much more common but less deadly arrhythmia. At the time, there was some controversy over whether it was best to let the heart beat irregularly and just slow down its rate or to try to convert it to a regular rhythm. One way to change the rhythm is shock therapy. Amiodarone provided a potential alternative to that, or in many cases, an adjunct.
The conventional wisdom has swung in favor of controlling the rate. It's very difficult in many cases to convert atrial fibrillation to a normal rhythm. It's often the result of worn out heart tissue in the elderly, and it's just impossible to get it to work correctly. And yet, amiodarone does seem to be used for this, at least according to Knight-Ridder:
According to recent data, doctors wrote more than 2 million prescriptions in a single year for atrial fibrillation and other heart conditions that amiodarone wasn't approved to treat. A Knight Ridder investigation last year found that those prescriptions represented 82 percent of all the amiodarone dispensed from retail pharmacies during the 12-month period ended July 31, 2003.
Earlier this month, a class-action lawsuit was filed in New Jersey that accuses drug makers of promoting amiodarone for common heart ailments in an effort to boost profits. The suit contends that more than 1,000 people have died, 100 have had vision problems and thousands of others have suffered severe medical complications.
I'm not sure how they knew what conditions the amiodarone prescriptions were meant to treat. Doctors don't usually write diagnoses on their prescriptions. But I've seen a dramatic decrease in amiodarone use for atrial fibrillation by the cardiologists in our area over the past couple of years. I suspect that most cardiologists are using it appropriately.
We See What We Want to See: The CDC has admitted that its claim that obesity is overtaking smoking as a public health threat was wrong:
A widely reported government study that said obesity was about to overtake smoking as the No. 1 cause of death in the United States contained statistical errors and may have overstated the problem, health officials acknowledged Tuesday.
...The Centers for Disease Control and Prevention said in March in a study co-authored by its director, Julie Gerberding, that a poor diet and physical inactivity were responsible for 400,000 deaths in 2000, a 33 percent jump from 1990.
....Although CDC officials declined to specify the corrected number of deaths, the Wall Street Journal reported that the agency may have overstated the number by 80,000, representing an increase of less than 10 percent from 1990 to 2000. The errors were first reported by the Journal on Tuesday.
The mistakes consisted of simple mathematical errors, such as including total deaths from the wrong year, the newspaper reported.
Ideologies and pet theories can be just as blinding to objectivity as profit motive. posted by Sydney on
11/24/2004 07:26:00 AM
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Tuesday, November 23, 2004
Coming Soon to a Bookstore Near You:Druglords, an FDA tell-all:
Dr. David J. Graham, the drug safety reviewer who denounced his employer, the Food and Drug Administration, before a Congressional panel last week, said yesterday that he feared being fired and had sought legal help from a group that protects whistle-blowers.
'My concern is retaliation from these people,' Dr. Graham said in a telephone interview.
His lawyer, Thomas Devine, legal director of a public-interest group, the Government Accountability Project, said that he had received anonymous telephone calls trying to discredit Dr. Graham and that he believed the calls were from people in 'F.D.A. management.'
Now, can he get Russell Crowe to play him in the movie?
The FDA's response to the controversy caused by Graham's accusations of persecution:
In 2001, a project officer [presumably Graham] in ODS[Office of Drug Safety] expressed interest in a scientific collaboration between the Office of Drug Safety and Kaiser Permanente of Northern California on the cardiovascular safety of cox-2 drugs. FDA provided partial funding for this pilot project in August 2001 and again a year later, and our project officer served as the project manager.
Last February, our project officer submitted an abstract to the International Society for Pharmacoepidemiology (ISPE) for presentation at the group's August meeting in Bordeaux, France. It described the final study population of nearly 1.4 million patients and the events being studied, but it included no results.
When this draft was shared with the project officer's supervisors within ODS to obtain review and clearance on August 11th, ODS supervisors immediately recognized the importance of the project officer's work and the need to complete a study report for FDA review and publication in a peer-reviewed scientific journal.
Some FDA scientists questioned some of the conclusions in the abstract and, as a result, the project officer voluntarily chose to revise his conclusions, and he did so, in his own words, "without compromising my deeply held convictions."
This poster was presented in Bordeaux in August and discussed publicly at that time. When he returned, his supervisors in ODS asked him to submit a draft report on his findings within two weeks. It was not submitted to the Center for review until September 30th, after Vioxx was voluntarily withdrawn from the market. Senior drug experts in FDA did not have this report or the underlying data prior to that time.
Second, more recently, the project officer notified his supervisors that he had submitted his findings in a paper to The Lancet. He did this without going through the long-established peer review and clearance process established for scientific papers submitted by FDA scientists. When FDA scientists learned that this paper had been accepted for publication in The Lancet, despite not having gone through the normal peer review process, the director of FDA's Center for Drug Evaluation and Research contacted the journal's editor, out of respect for the scientific peer review process.
Let's see. The whistle blower doesn't hand in his assignments on time and he ignores inhouse rules about peer review so he can rush his paper to The Lancet, which is notoriously lax when it comes to critically reviewing papers - especially papers that are topical and fit in with the news story of the day. (It was The Lancet, remember, which published the paper wrongly linking the MMR vaccine to autism, and it was The Lancet which rushed to publish a deeply flawed statistical analysis of Iraqi civilian deaths just days before our Presidential election.) Sounds like he's more interested in burnishing his own image. Our drug approval process certainly has its problems, but there's something fishy about this guy. posted by Sydney on
11/23/2004 11:45:00 PM
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Worth Noting: Among the data in the statin/muscle injury study mentioned below was this graphic illustrating the rocketing ascent of Lipitor over the past ten years compared to other statins. Do you suppose it could have anything to do with articleslikethese? Note that two of those studies were inherently designed to give the edge to atorvastatin over the comparison drug by using twice the dose. Nonetheless, they were published in our two most prestigious medical journals with nary a comment on their bias. Pharmaceutical companies and medical researchers certainly have a tendency to skew results favorably, but they're amply aided and abetted by the editors who publish their papers in the journals.
posted by Sydney on
11/23/2004 11:03:00 PM
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Those We Love to Hate: The pharmaceutical industry can't get no respect:
New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.
This time it's Baycol, a cholesterol-lowering statin that Bayer AG withdrew in 2001 after some who took it developed a severe and sometimes fatal muscle disorder. A new study found that the risks were far greater than had been believed.
....Six papers on the issue were to be released Monday and will be published Dec. 1 in the Journal of the American Medical Association. Its editors called for a new, independent office separate from the FDA to monitor drugs after they're on the market.
'It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong,' they write.
All of the articles are available on the JAMA website for free, although some of the links don't work or are mislabeled. Here's the one that takes Baycol's maker to task. It's authors may have their own conflict of interest. They're expert witnesses for plaintiff's attorneys in Baycol lawsuits. (The Bayer lawyer responds here, and the expert witnesses get the last word here.) The expert witnesses do, however, provide a nice summary of how and when things changed at the FDA:
In the late 1980s and early 1990s, the pressure from companies and patients alike was not for additional safety evaluations but for shorter approval times. In response to the criticism that the FDA approval times were too long, the US Congress introduced user fees in 1992. Pharmaceutical companies that sought drug approvals paid fees that enabled the FDA to hire additional staff, and the FDA was expected to meet new requirements for the timeliness of new drug approvals. During the approved lifetime of cerivastatin, however, the 1992 User Fee Act and its reauthorization in 1997 prohibited the agency from spending users fees "on post-marketing surveillance or other drug-safety programs." The FDA received no additional funds from the US Congress for postmarketing safety despite the fact that many new drugs were first marketed in the United States. In 2001, for instance, the FDA’s Center for Drug Evaluation and Research approved 66 new drugs, 24 of which were new molecular entities never before marketed in the United States. This approach—more and faster new approvals without additional funds for safety surveillance—relied increasingly on the pharmaceutical industry to conduct its own postmarketing safety evaluations.
That would seem to be a problem. Having the industry fund the body that's supposed to be regulating them is an inherently bad idea, and the mandated timelines for drug approvals need to be revisted. It's one thing to work fast to get a potentially life-saving drug to market for a disease that's fatal (such as cancer drugs), but it's quite another to put a rush on these preventive medications of marginal value. As Paul Abramson points out in Overdosed America, 100 people have to take statins for two years to prevent just one heart attack. They deserve a little more scrutiny, especially when it comes to long term side effects.
One of the free JAMA articles looks at the rates of one complication among statins - the break down of muscles, called rhabdomyolysis, and declares the majority of them to be safe (brackets are mine):
The incidence rates for rhabdomyolysis for monotherapy with atorvastatin [Lipitor], pravastatin [Pravachol], or simvastatin [Zocor] remained statistically indistinguishable over time. For therapy intervals of less than 6 months, 6 to 12 months, 13 to 24 months, and more than 24 months, the incidence of rhabdomyolysis per 10,000 person-years was 0.7 (95% CI, 0.3-1.6), 0.2 (95% CI, 0.01-1.2), 0.2 (95% CI, 0.01-1.1), and 0.6 (95% CI, 0.1-2.1), respectively. A similar pattern was observed with cerivastatin [Baycol] and fibrate [Lopid] monotherapy.
But this week's Medical Letter takes a look at the literature and finds a slightly higher incidence of rhabdomyolysis:
Dose-related muscle complaints are the most commonly reported adverse effects of statins. The most serious, myositis with rhabdomyolysis, is rare and often associated with drug interactions; about
1-3 cases have occurred per 10,000 treated patients, with a mortality rate of 8%. The rate of rhabdomyolysis appears to be similar with all currently marketed statins.
For this study, the researchers compared the brains of 26 volunteers who had been suffering from back pain for more than a year with those of 26 people without back pain. They found that the decrease in gray matter volume was directly linked to the length of time the patient had been in pain.
Hard to tell what the clinical significance of this is, except that this comment was interesting:
"Chronic pain patients, and specifically chronic back pain patients, seem to have impairment in emotional decision making," Dr. Apkarian said.
The study doesn't mention if their subjects used any drugs or if they did, what types of drugs, to try to control their pain. Were all of the chronic back pain sufferers also chronic narcotic users? If so, couldn't that have had an effect on brain volume, just as alcohol does? posted by Sydney on
11/22/2004 08:36:00 PM
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Brainy Matters: What happens when you blow your nose too hard. (Joking. This was the result of an auto accident.) posted by Sydney on
11/22/2004 08:16:00 PM
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"Why not change minds instead of bodies?" asks Alice Domurat Dreger in her new book in reference to people who are born with bodies different from those of us who consider ourselves normal. Her primary subject is conjoined twins, one of the most extreme examples, but she also brings into the story people with cleft lips, dwarfs, giants, and hermaphrodites. Since we cannot conceive of being willing to live with these abnormalities, we usually think that such conditions should be fixed by modern medicine, if possible. That, says Dreger, is the problem. Normalization procedures may sometimes be the best choice, but they are not the only option. Many people with unusual anatomies are completely comfortable with their bodies and derive their personal identities from them. It is the discomfort of their families and communities that most often exerts the pressure to change them.
Conjoined twins are in some ways the most urgent issue to confront, since high-risk separations are more often life-or-death situations than are other corrective procedures. Dreger understands the reasons for such separations, especially the fact that modern medical techniques have made them possible and usually successful, but she challenges our idea of what constitutes success. She finds it is often limited to the brief survival of one or both twins or subjecting survivors to years of hospitalizations and surgeries. Separations that require the deliberate sacrifice of one child in order to increase the viability of the other also force us into extremely difficult ethical decisions.
Politician Medical Watch: Condeleeza Rice had surgery last week. She had a uterine fibroid destroyed by embolization. Unlike Arafat and Chief Justice Rehnquist, there's every reason to believe that she really will be back to work next week. posted by Sydney on
11/21/2004 08:37:00 AM
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Salesmanship: An Ohio businessman has made a fortune selling faux pharmaceuticals. He's coming under attack by consumer groups and the Ohio attorney general and the FDA for false advertising. But, as he points out, what he's really selling is the placebo effect:
Warshak considers it misguided to talk about the effectiveness of Berkeley's products.
'It's not about whether something works or doesn't work,' he said. 'It's more about whether it can help or not.' posted by Sydney on
11/21/2004 08:34:00 AM
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Rolling Downhill: All the bad press the drugs have been getting lately about side effects and unforeseen risks is the fault of general practitioners, so says the head of Astra-Zeneca:
McKillop proposed that the industry should adopt a system of conditional approval, whereby new drugs would be closely monitored for side effects after receiving their initial marketing licence.
McKillop said this could prevent some of the controversies that have battered the pharmaceutical industry in recent years. It would prevent innovative — and therefore potentially risky — new medicines being indiscriminately prescribed by inexpert general practitioners.
Does that mean they'll drop direct to consumer advertising for these new drugs? And detailing by sales reps?
And by the way, the number one prescribers of Crestor, Astra-Zeneca's controversial new cholesterol medicine, are cardiologists, at least in my geographical area. They're giving it out like it was candy. posted by Sydney on
11/21/2004 12:13:00 AM
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