Patient Safety Blog

The FDA says it is re-investigating the issue of whether drugs like Fosamax, which are given to post-menopausal women, can actually cause fractures of the thigh bone (femur).

A number of lawsuits are pending about death of jaw bone tissue allegedly caused by this family of drugs, called biophosphonates.

Previously the FDA said it had seen no link between these drugs and femur fractures. But new studies reported at the annual meeting of the American Academy of Orthopaedic Surgeons raised questions about the risks for long-term use of bisphosphonates by post-menopausal women.

The FDA says it will consult with outside experts. Meantime, it says people on the medications should continue taking them but should talk to their doctors if get any new hip or thigh pain. See the FDA's news release here.

Bisphosphonates have combined annual sales topping $3.5 billion. In addition to Fosamax, drugs in the group includes Actonel marketed by Sanofi-Aventis and Procter & Gamble, Boniva marketed by Roche and GlaxoSmithKline, Novartis’s Reclast and P&G’s Actonel.

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New ethics rules that bar Harvard doctors from giving speeches paid by drug manufacturers have prompted one doctor to give up his prestigious academic position in favor of keeping the income from the speeches. The physician is Dr. Lawrence M. DuBuske, an allergy and asthma specialist who is quitting his positions at Boston's Brigham and Women’s Hospital and Harvard Medical School. According to the Boston Globe, Dr. DuBuske made about $100,000 in three months last year giving some 40 speeches for six drug makers, including GlaxoSmithKline.

The ethics rules were put in place by Partners HealthCare, the physicians' group that employs most Harvard-connected doctors.

One Globe reader put this in a good perspective:

It's a good thing that he resigned. Now, when he speaks, the information he presents will be judged by the standards of a paid speaker employed by an entity with interests, rather than a disinterested academic. Meanwhile, he remains an expert allergist, and will likely find a place to practice.

The contacts between drug companies and academic medicine are extensive. They should be. You want the best, smartest, most creative docs involved in drug (and device) production. But the money involved is huge, and some will get seduced by the Green Side of the Force. Full disclosure of interests is a step, but only a step.

For patients, it helps to know if the prescription the doctor is writing for you has even a hint of a special interest from the drug maker. The many blandishments that drug makers lavish on doctors -- even small things like pens and scratch pads, plus free meals and "fees" for speaking at seminars -- are known to do their job of creating subtle influence on the prescription writer.

That's why I recommend that patients look for doctors who have the "no free lunch" philosophy: they accept nothing whatsoever, including samples, from the drug makers. That leaves their judgment completely independent.

You can read more about the "no free lunch" movement in medicine at this website.

I have a whole chapter in my book, "The Life You Save," on how to become a smart consumer of medicines.

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Posted In: Conflicts of Interest , Medications

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In a logically designed drug safety system, data from new studies would automatically be pooled so that as more and more patients take a drug, researchers can see potential harms across all the data at one time, rather than looking at individual research studies in isolation. Alas, that is not our world.

A new proposal would change that, but it would take an act of Congress to do so.

As described in the Archives of Internal Medicine, a group of researchers analyzed all the studies published on Merck's anti-arthritis drug Vioxx to see when the risk of heart attack could have first been identified. The drug was first put on the market in 1999 and was taken off the market in September 2004 when Merck said it first realized there were many heart attacks in patients taking it.

The researchers led by Joseph Ross, M.D., now say that their analysis, pooling data from 30 separate clinical trials, shows there was statistically significant increase in heart attacks in Vioxx patients as early as June 2001, three years before the drug was removed from pharmacy shelves. The studies after 2001 only strengthened the statistical association, they say.

If we had a system in place that automatically pooled all safety data on drugs as new studies are published, many safety risks could be identified much sooner.

But the head of drug safety at the Food and Drug Administration, Dr. Janet Woodcock, said Congress would have to authorize a change in the existing monitoring system to make for these automatic updates. Currently, she told the New York Times, the FDA does such combined-study reviews but only when a particular drug catches the eye of FDA safety officers.

Consumers are well advised to hold off on taking new drugs until they have been on the market for seven years. This is the advice I give in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

Seven years is enough time for safety experts to see whether the new drug has enough benefits that outweigh its harms. In theory, the approval by the FDA to let a drug be sold should provide that green light, but before a drug is approved, only a few thousand patients typically are studied, while many hundreds of thousands will take a drug in the years after approval.

The new study by Dr. Ross and colleagues is yet another example of how far we have to travel before consumers can be assured that a brand new drug is right for them.

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Posted In: Medications

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Most doctors have to take regular continuing education courses to maintain their medical licenses. But what if the courses have a hidden agenda -- promoting the drugs of a sponsoring manufacturer?

That hidden influence has occurred far too often for the comfort of patient safety advocates, who want prescribing doctors to receive fair, balanced and neutral advice in the important subject of what prescriptions to write for sick patients.

Now the group that gives the official seal of approval for continuing education courses is taking tentative steps to curb the drug industry's influence on these courses. The group is called the Accreditation Council for Continuing Medical Education (ACCME). Its approval is necessary for a doctor to get official credit for any course taken. The head of the ACCME, Dr. Murray Kopelow, told the New York Times he will:

First, make public in the next few weeks a list of the classes and educational companies that have already been found to have broken the rules against commercial bias. This list was previously secret. Apparently there are less than a dozen names on the list as of now.

Second, consider further steps such as requiring the sponsor of a course found to be biased to send out corrective material to the doctors who took the course.

A doctor who is pushing for these and stronger reforms is Dr. Bernard Carroll, who filed a lengthy complaint about an online course on treatment of major depression, which he said was strongly biased by hiding bad information about the drugs of the sponsor, AstraZeneca.

The Times reported:

Dr. Carroll faulted the accrediting council for taking nine months to resolve the complaint, allowing the program to rerun and failing to notify doctors who had taken it. “They’re more interested in protecting the providers than watching what gets put out there as education,” Dr. Carroll said in an interview.

Here is Dr. Carroll's own blog posting on the subject.

The steps taken so far by the accrediting body are modest, but go in the right direction. Let's keep watching. As another industry critic, Dr. Bernard Lo, said, it's okay for the drug industry to support medical education. What's not okay is to create commercial bias in favor of one or another company's products.

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Posted In: Accessibility of Healthcare , Conflicts of Interest , Disclosure , Medications

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A few brave medical journal editors are cracking down on the common practice of drug companies ghost-writing articles for authors who are willing to lend their names to drug industry propaganda. But at other journals, editors seem to have a "don't ask, don't tell" policy. For patients, it is vital that the truth come out.

The problem with ghost-written medical articles is that they purport to be something that -- once the disclosure of who wrote them is made -- they clearly are not: independent, objective evaluations of which medications work best for a particular disease. Instead, the ghosted articles turn out to be elaborate infomercials, disguised by the author's prestigious name and studded with multiple footnotes and the other signs of scholarly elbow grease. Yet because they are published under false pretenses, these articles can be very effective at selling their sponsors' products.

What first broke open this scandal was lawsuits against Wyeth for breast cancer and other injuries caused by its hormone drugs Prempro and Premarin. Attorneys for the patients found multiple examples in the manufacturer's records of prominent medical researchers putting their names on articles written by someone hired by the drug company.

Some of the medical school professors who were caught tried to brazen their way out of it by saying that of course, they wouldn't put their name on something they didn't agree with, and they just happened to agree with every single word that was written for them. For example:

Dr. Gloria Bachmann of the Robert Wood Johnson School of Medicine said in a published report: “This is my work, this is what I believe, this is reflective of my view.”

With shameless attitudes like that rife in the medical academic world, it's important for the editors who control what goes into the journals to step up and enforce some accountability. The first steps down that road have been cautious at best. As the New York Times reported:

Dr. Cynthia E. Dunbar, the editor in chief of Blood, said that, in the future, the journal would consider a ban of several years for authors caught lying about ghostwriting, in addition to retracting their ghosted articles.

But, said Dr. Dunbar, who is a hematologist at the National Institutes of Health in Bethesda, “I hope we don’t have to do that.”

The Times reported on another journal that took a stand:

In an editorial last week calling for a zero tolerance policy, the editors of the medical journal PLoS Medicine, from the Public Library of Science, called for journals to identify and retract ghostwritten articles and banish their authors.

“Any papers where this breach is substantiated should be immediately retracted,” the editors wrote. “Authors found to have not declared such interest should be banned from any subsequent publication in the journal and their misconduct reported to their institutions.”

Click here to read the full editorial.

Other journal editors told the Times that because they banned ghostwriting, they didn't really have to have a specific policy enforcing the ban. Huh???

For an amusingly arch, tell-it-like-it-is take about medical ghostwriting from someone outside the medical industry, I recommend English professor Margaret Soltan's blog, University Diaries.

The ghostwriting scandal, and the cautious, tepid response from many in the medical journal world, are the latest proof of why I advocate that patients be skeptical about prescription drugs, especially those with expensive marketing campaigns behind them. Read more in Chapter 7 of my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." The chapter is titled: "Drugs: A Dose of Reality About the Prescription Drug Industry and How You Can Safely Use Medicines."

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Posted In: Communication , Conflicts of Interest , Disclosure , Medications

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A lawsuit by the state of South Carolina has turned up evidence that one sales representative for Eli Lilly bet golf scores with a doctor client -- and the payoff was the doctor's agreement to write more prescriptions for the drug Zyprexa.

According to an article by Bloomberg News, notes from this and other sales reps showed attempts to get the doctors to prescribe Zyprexa for "off-label" uses -- those for which the manufacturer had not shown evidence to the FDA that the drug was safe and effective.

The state is trying to get a court to force Eli Lilly to refund excessive spending in the state Medicaid program on Zyprexa prescriptions. Lilly has settled one state lawsuit from Alaska and also agreed to a U.S. Justice Department settlement that involved thirty other states.

The inducements to doctors to prescribe the powerful antipsychotic drug included deep-sea fishing trips and speaker fees for those doctors who would address meetings of their colleagues, according to the suit.

This is yet another example of why I urge patients to be skeptical about drugs and to try to find a primary care doctor who doesn't take freebies from drug manufacturers. Even the most innocuous of handouts from drug companies can influence how a doctor writes prescriptions. Read more about this in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst."

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Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are "ghost-written" by drug manufacturers.

According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth's hormone replacement drugs Premarin and Prempro show that over several years, Wyeth repeatedly hired ghost writers who placed 26 articles in 18 prestigious medical journals, all promoting the drugs in the guise of objective analysis by medical experts:

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The Times article made an interesting comparison to professional baseball's steroids scandal.

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

“The filter is missing when the reader does not know that the germ of an article came from the manufacturer,” said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

The same concern about ghostwriting applies to patients who read literature on the Internet. People can be easily misled if they think an article is truly objective.

My advice, as I write in my book, "The Life You Save," is to rely on truly independent groups like the Medical Letter and Public Citizen's Health Research Group for objective information about drugs.

Some top medical journals like the Journal of the AMA now require authors to fill out detailed forms describing exactly how much input they had into the writing of an article. But many do not have such requirements. Consumer, beware.

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Posted In: Communication , Conflicts of Interest , Medical Device Safety , Medications , Product Safety

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They seem so benign -- those free samples of prescription drugs in bubble packs that your doctor hands out at the end of an office visit. But there are plenty of hidden costs in free samples, and two prominent doctors have written an essay asking that the pharmaceutical industry stop the $15 billion a year practice of what is called "sampling." In an article by Susan Chimonas and Jerome Kassirer (former top editor at the New England Journal of Medicine), they write:

The samples that drug representatives offer are almost never time-worn and well-tested drugs, nearly never generics, and usually comprise the newest agents on the market. As such, they expose patients to risks not yet identified in clinical trials. The experience with Vioxx is a case in point. By 2002, only three years after Vioxx was introduced, it became the most widely distributed sample [3], and two years later the drug was withdrawn from the market because of an excess risk of myocardial infarctions and strokes [9]. Needless to say, Vioxx was not the only drug given extensively as samples and later found to enhance risk. Samples given to pediatric patients have similarly been associated with notable safety concerns. In 2004, four of the 15 medications most frequently given as samples to children in the US received new or revised “black box” warnings from the US Food and Drug Administration within two years of approval [10]. Finally, patients may not be the only ones at risk from distribution of free samples. Physicians who offer samples to patients and fail to supply appropriate cautions and warnings about the use of these drugs may be subject to liability, along with the company that promoted the drug [11].

There are plenty of other problems with "sampling." It encourages casual use and misuse of potent drugs. It doesn't really help indigent people get affordable medications. It bypasses the pharmacist, who provides user-friendly educational pamphlets that can alert patients to potential problems with the drug.

The authors conclude:

The tradition of physicians dispensing samples has many serious disadvantages and is as anachronistic as bloodletting and high colonic irrigations. As the profession begins to slowly extract itself from the influential grip of industry, it must also deal with the undue influence of free samples.

The article is also reprinted in Public Citizen's "Worst Pills, Best Pills" newsletter.

In Chapter 7 of my new book on health care, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, I discuss the idea that safe and wise use of prescription drugs includes not taking a drug during its first five to seven years on the market. That's because the real hazards of a new drug are not well known until it has been widely used. For the same reason, it's a good idea to avoid free samples, which usually are newer drugs that don't have the safety track record of established drugs. The only exception is for "breakthrough" drugs that truly offer treatment where no drug was available before.

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The recent news that an FDA advisory panel has proposed that Vicodin and Percocet be taken off the market because of their acetaminophen content has prompted a discussion about the overall safety of this drug, which is best known as Tylenol and is present in a number of both prescription and over-the-counter pain drugs.

The New York Times' Tara Parker-Pope had a good summary in her Well blog, in which she said acetaminophen is generally safe when taken within the maximum dosing guidelines of no more than four grams -- 4,000 milligrams or 8 extra-strength tablets -- per day. But there is one big exception that she didn't discuss: for people who regularly drink alcohol, the daily limit of acetaminophen should be much lower. I explained this in a comment to her blog entry. Here is the text of what I posted:

The link between acetaminophen and alcohol deserves to be clarified because it is not that straightforward but is actually pretty easy to understand. Regular alcohol drinking “induces” a metabolic pathway in the liver called P-450 2E1, making the liver more efficient at breaking down alcohol with this 2E1 enzyme. This happens within a few days of drinking 2 or 3 or 4 drinks a day. That’s why steady drinkers can “hold” their liquor better, because they are breaking it down faster and so less alcohol gets in the blood. When you stop drinking for a few days, the liver reverts back to its old self and so the first time you drink again, your liver is less efficient at breaking down the alcohol so you get a “buzz” with the first drink. Here’s how this relates to acetaminophen: The same 2E1 enzyme turns acetaminophen into the toxic byproduct (called NAPQI) that can destroy the liver. So regular drinking produces more 2E1 and hence more NAPQI, and the more acetaminophen you take, the more the NAPQI can overwhelm the liver’s other defense mechanisms and cause liver cell death. But here’s the twist: drinking alcohol at the same time as you take acetaminophen puts both drugs into the liver at the same time, competing for the same 2E1, and thus drinking at the same time actually can protect against liver damage. The deadly pattern is when a drinker gets sick, with the flu for instance, stops drinking and starts taking acetaminophen near the maximum 4 grams a day, and that can cause catastrophic liver failure (because the 2E1 has nothing else to do but turn the acetaminophen into the NAPQI). I know about this because as a lawyer I represented a number of Tylenol victims in lawsuits in the mid-1990s that helped get the alcohol warning onto acetaminophen labels. I took many depositions of the medical people at McNeil, the Tylenol manufacturer.

Anyone who drinks regularly should take no more than 2 grams of acetaminophen a day. Any liver specialist will tell you that.

I talk about what I call the safe and skeptical approach to taking medicines in my new book: “The Life You Save: Nine Steps to Finding the Best Medical Care — and Avoiding the Worst.”

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At the annual conference of the American Society of Clinical Oncology, scientists presented a new study that found certain antidepressants may interfere with the effectiveness of tamoxifen, a drug commonly taken by breast cancer survivors to keep the cancer from coming back, according to an Atlanta Journal-Constitution article.

Tamoxifen has been used for decades to treat breast cancer and, for the survivors, to prevent tumors from forming again. One of the most common side effects of tamoxifen is hot flashes, which can be controlled by SSRI (selective serotonin reuptake inhibitor) antidepressants such as Paxil and Prozac. The new study shows that this cocktail of drugs seems to account for a higher recurrence rate of breast cancer. The study followed almost 1,500 women whose average age was in the early 50s. Researchers found that women who took both tamoxifen and the SSRI antidepressants were almost twice as likely to have their breast cancer return within two years.

At the same ASCO conference, another paper was presented that found no correlation between breast cancer recurrence rate and use of antidepressants. However, authors of this second study pointed out that this study included a much smaller pool of subjects, and they join authors of the first study in recommending that other options should be considered to treat hot flashes.

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Posted In: Cancer , Medications

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Stroke experts have widened the window for when the clot-busting drug tPA can be given intravenously. The previous U.S. guideline was to give the drug only if treatment could be started within three hours of the onset of symptoms. Many patients did not get the drug because they didn't get to the hospital in time or it took too long to do tests to make sure the drug could be helpful. (Everyone with stroke symptoms has to have a CT scan to make sure the stroke is not caused by bleeding in the brain, because if tPA is given on top of bleeding, it could worsen the hemorrhage or even kill the patient.)

The new guideline widens the effective time window to four and one-half hours after symptoms start. It comes from the American Heart Association/American Stroke Association and is based on European studies.

Stroke experts stress that just because there is more time now to administer this drug does not mean patients or doctors should think they can go slow. The faster treatment is begun, the more likely it is to help break up the clot and restore normal blood flow in the brain. Anyone with stroke symptoms needs to be rushed to a hospital with special expertise in stroke treatment.

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Posted In: Medications , Standard of Care--Hospitals , Stroke

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Acetaminophen, the unpronounceable name for the active ingredient in Tylenol, is the most widely used pain reliever in the United States. But it can destroy the liver in ordinary or near-ordinary doses. That fact is news to many consumers but is old hat to liver specialists who every week treat patients at death's door from acute liver failure due to acetaminophen.

It has now been documented that acetaminophen is the most common cause in the U.S. of acute liver failure, which can result in death if a liver transplant cannot be done.

The Food and Drug Administration has recognized that acetaminophen poisoning is a public health issue and has slowly taken steps to educate the public to this popular drug's dangers. In April 2009, the FDA mandated a new warning label, which will say on 500-mg products (Extra Strength Tylenol and its generic equivalents): “Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than eight tablets in 24 hours, the maximum daily amount.” It will also warn against using it with other acetaminophen products or with alcohol use of three or more drinks a day. The FDA rejected a request from the Tylenol manufacturer McNeil to water down the warning by removing the word “severe” and adding the word “overdose,” which the agency said could lead consumers to believe they had to greatly exceed the recommended dosage before jeopardizing their livers.

This warning won't take effect until spring 2010. FDA advisors first recommended such a liver warning in 1977.

In the meantime, an FDA advisory panel will meet in late June to consider other steps intended to make it harder to accidentally cause liver failure from taking too much acetaminophen. A "working group" of advisors has recommended among other things:

• limiting the single adult dose to a maximum of 650 mg, and limiting tablet size to 325 mg (down from the current extra-strength size of 500 mg and single dose of 1000 mg);
• lowering the maximum daily dose for adults from 4000 mg to no greater than 3250 mg (and less than that for chronic alcohol users);
• restricting pediatric liquid formulations to a single mid-strength concentration;
• eliminating acetaminophen from combination products.

You can read the working group's recommendations at the FDA's web site here.

In the 1990s, Patrick Malone was one of the first attorneys in the United States to successfully sue the Tylenol manufacturer for hiding the dangers of acetaminophen from doctors and the public. Read about his case of Benedi v. McNeil here. Watch the ABC Prime Time Live segment on this subject by clicking here.

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Posted In: Medications , Product Safety , Self-care

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Starting July 1, Vermont residents will be able to learn exactly how much money any doctor in that state is receiving from the drug and medical device industry. The state is also banning most gifts like free meals to doctors, nurses, pharmacists and other health care providers.

This is an important step forward in eliminating the conflicts of interest that plague use of prescription drugs in the United States.

Vermont already has publicized non-doctor-specific data on drug industry payments intended to influence doctors. Even in a small state like Vermont, the total spent last year was $2.9 million, with most of the money targeted to doctors thought to be influential with their peers. The biggest single payment was $112,000 to a psychiatrist. And the drugs which topped the list for money paid were Strattera, a drug for attention deficit disorder, and Cymbalta, for depression and anxiety.

The new legislation was reported in an article by Natasha Singer in the New York Times.

Doctors and drug companies often deny that free meals and payments of consulting fees have any influence on doctors' prescribing habits. The mere fact that the industry spends hundreds of millions of dollars each year on such marketing suggests otherwise. Commendably, the Vermont Medical Society supported the new disclosure law.

Patrick Malone discusses conflicts of interest and how patients can use drugs -- sensibly, skeptically and safely -- in his new book: The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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Posted In: Conflicts of Interest , Disclosure , Medications

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One day after the FDA approved a new antiwrinkle drug (Dysport) in April 2009, the agency issued a new requirement that these drugs must carry a “black-box” warning label, the strongest safety warning typically reserved for drugs with very serious risks, Natasha Singer reports in a New York Times story. A popular antiwrinkle drug in the U.S. is Botox.

Botox and Dysport are injectable drugs developed from botulinum toxins, which temporarily paralyze the muscle into which they are injected. When administered for approved uses at approved doses, the botulinum toxins cause no harm. However, if used improperly, the toxins can travel from the injection site to other parts of the body, causing difficulty with swallowing or breathing.

Approved uses of injectable botulinum toxins include treatments for crossed eyes, eyelid spasms, severe underarm sweating, frown lines, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position.

According to the new FDA requirement, the drug manufacturers not only have to add the black-box warning labels, they also have to inform doctors of the risk information in writing, and make available a medication guide to patients at the time of injection.

Patients are well advised to read all handouts on drugs they take, especially something used for cosmetic purposes. Every drug has risks and must be taken with caution.

Ten rules for safer drug use can be found at Public Citizen's Health Research Group website. These rules and more tips for safe drug use are discussed by Patrick Malone in his book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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Posted In: Disclosure , Medications , Product Safety

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Strokes cause more disability than just about any other disease, but they don't have to. Effective treatments are known for the most common type of stroke; delivering them to the right patients has proven to be difficult. Now a group of researchers is proposing some changes in how stroke care is organized, with the hope of matching reality to the promise and greatly improving stroke outcomes.

In 1995, a landmark study was published showing that the impact of stroke on the human brain could be greatly diminished by using clot-busting drugs to dissolve the clots that kill brain cells in ischemic stroke. (Ischemic stroke is responsible for about four of five strokes. In ischemic stroke, brain tissue dies because blood clots or narrowed blood vessels block flow of oxygen-rich blood to brain tissue. In hemorrhagic stroke, which affects about one in five stroke patients, brain tissue dies because a burst blood vessel causes bleeding in the tissue.)

Today, though, it is estimated that fewer than one in ten victims of ischemic stroke are treated with either intravenous tPA, the main clot-dissolving drug, or other effective treatments, such as breaking up the clot with a mechanical device inserted inside the blood vessel.

The accepted convention is that tPA does not work unless the i.v. is started within three hours of the onset of stroke symptoms. Most patients don't get to the hospital that quickly, and even when they do, time is eaten up by the necessity to give everyone a CT scan to make sure they are not having a bleeding stroke, for which use of the clot-dissolving drugs could be a disaster.

A new article by Drs. Reza Hakimelahi and R. Gilberto González, "Neuroimaging of Ischemic Stroke With CT and MRI: Advancing Towards Physiology-Based Diagnosis and Therapy," advocates these changes to help deliver more of these proven treatments to more patients:

* Doctors need to recognize that the three-hour window for treatment sometimes is much longer in patients who have blockages of smaller vessels in the brain with some temporary compensation through "collateral" vessels. Better imaging studies can identify these patients who have an "ischemic penumbra" that would benefit from clot-dissolving drugs.

* Many patients can benefit, even after the three hours has expired, by direct intervention with mechanical devices to break up clots from the inside of the vessels. Because this requires expertise in interventional neuroradiology, a field with only a few hundred practitioners in the United States, the authors recommend cross-training for doctors in related fields who know how to use tiny tubes inside blood vessels to deliver treatments. These include interventional cardiologists.

* Hospitals that are recognized as expert in care of acute strokes could be divided between advanced and general levels of expertise. On the general level, any such hospital needs to have 24-hour CT scanning and the ability to give clot-busting drugs in the emergency department. To qualify as an advanced stroke center, the hospital would have to have the ability to do interventional treatments inside blood vessels ("endovascular therapy"), a neuro-intensive care unit, and a team of doctors from multiple specialties that work together to decide the best treatment for each patient.

(NOTE: To read this article, you have to sign up for a free membership at Medscape.com.)

As these ideas are debated in the medical industry, the best strategy for patients is to have some advance knowledge and basic planning. Knowing how common strokes are, and how urgent the timeline is ("Time Is Brain" in stroke treatment) once stroke symptoms start, here is what I advocate:

* Know the basic symptoms of stroke, and don't rationalize your way out of a trip to the hospital if the symptoms seem mild or go away after a few minutes. Here is a basic list from the American Stroke Association:
* Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
* Sudden confusion, trouble speaking or understanding
* Sudden trouble seeing in one or both eyes
* Sudden trouble walking, dizziness, loss of balance or coordination
* Sudden, severe headache with no known cause

* Know which hospital in your area has advanced stroke treatment staff and machines. Ask if they have a multi-disciplinary team. (It should include both neurosurgeons and endovascular therapists.) Ask if they have a neuro-intensive care unit (an ICU that treats only patients with brain or spinal cord problems).

* If a loved one suffers stroke symptoms, do not let the rescue squad take them to the nearest emergency room UNLESS the same hospital has advanced stroke treatment abilities.

* A multi-disciplinary team is important because conflicts of interest can drive doctors to advocate for therapy they can do when a safer, more effective treatment might be available from a doctor with different training. Having doctors work together to help the patient and family decide treatment is the best approach.

In his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, Patrick Malone discusses one tragic case in which a patient needed a teamwork approach to her neurological problem but didn't get it because the hospital had no effective team in place. The book discusses the questions to ask to make sure your doctors are working together and not as competitors for your health care business.

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Posted In: Accessibility of Healthcare , General , Medications , Standard of Care--Hospitals

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An Institute of Medicine report released on April 28, 2009, denounces the adverse effects that the health care system suffers from the free gifts regularly pumped into hospitals, medical schools, and doctors’ offices, writes New York Times’ Gardiner Harris. The report strongly advises doctors to stop accepting the gifts. The report says that accepting gifts would “create conflicts of interest, threaten the integrity of their missions and their reputations, and put public trust in jeopardy.”

When doctors accept gifts from drug companies – which may be money, drug samples, office supplies or food – they change their prescribing habits. This change may or may not be conscious, but the “reciprocity instinct” that prompts people to return a favor is part of human nature that has been recognized by psychologists and anthropologists. And when this happens, the patients are the real victims: their doctors may prescribe new drugs that are yet to be tested for their safety or effectiveness, or drugs that patients can easily replace with diet or lifestyle changes.

In his new book, The Life You Save: Nine Steps to Finding the Best Medical Care – and Avoiding the Worst, Patrick Malone discusses steps patients can take to avoid being victims of such conflicts of interest. He also explains how an average patient can dissect statistics on drug performance to determine if a particular drug is really as effective as it’s marketed to be.

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Posted In: Disclosure , Doctor-Patient Relationship , General , Medications

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In its letters sent to 14 pharmaceutical companies in March 2009, FDA required risk information to be included in the Internet search advertisements of drugs – a move welcomed by consumer advocates, reports Stephanie Clifford in a New York Times story.

The short text ads that appear to the right of Google search results are limited to 95 characters, in which space pharmaceutical companies are now required to include not only the drug’s name but also its risk information. Although the drug companies had made risk information available just one click away from the search ads, which linked to a webpage containing detailed information of the drugs including side effects, the FDA issued this new requirement to ensure consumers are not misled.

Rita Chappelle of the FDA said in an NYT interview that it’s “vital and critical” that consumers do not mistakenly believe the drugs to be safer or more effective than they really are. This precaution is especially important in drugs that have frequently occurring or serious side effects, such as depression, liver damage, infections or severe allergic reactions.

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Posted In: Disclosure , Medications , Product Safety

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Blood clots that develop in the large veins of the calf can kill if they break off and travel up to the heart. That's what is called a pulmonary embolism, the killer of some 100,000 Americans every year. Now there's evidence that statin drugs for lowering cholesterol, and thereby preventing clogging of the arteries in the heart (thus lowering heart attack risk), may also lower the risk of clots developing in the veins, and dramatically so.

But don't demand a statin drug prescription from your internist just yet. You have to understand your own statistical risk first.

According to a major study of 18,000 patients, as reported in the New York Times, the patients who took the potent statin drug Crestor (rosuvastatin) had a 43 percent lower risk of blood clots in the leg veins than patients who took a placebo pill in the same study.

That's an impressive number. But more revealing, perhaps, is the actual number of patients that percentage represents. In the 18,000 patients, only 94 developed blood clots -- 34 in the group taking Crestor and 60 in those taking the dummy pill, thus the 43 percent difference. But the overall risk is so small that no responsible doctor would recommend people take a statin drug long-term to prevent blood clots in the legs, UNLESS you have some specific high risk for such blood clots -- such as a history of having them in the past.

This blog has made a similar point with other "breakthrough" reports on drugs -- actually on the same study with the same drug, when it reported in late 2008 that Crestor might reduce heart attack risk even in patients without high cholesterol. You have to count the actual numbers of patients affected and understand where you fit, before you can make an intelligent commitment to long-term use of a drug. This issue is discussed in more depth in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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Never underestimate the ingenuity of the pharmaceutical industry in promoting its products to the American public. The latest example: The "Real Age" questionnaire that millions of people have filled out on the Internet, to tell them if their "real age," based on lifestyle and family history, is younger or older than their chronological age.

It turns out that the company that sponsors the Real Age web site sells to pharmaceutical companies the detailed information it receives from patients who fill out the 150 questions in its survey. The actual names and email addresses of patients do not get transmitted to the drug companies, but Real Age sends emails to patients on behalf of the drug companies, and these emails are targeted to what a drug company thinks that patient might be interested in, based on the patient's responses to the Real Age questions.

All this happens, according to a report by Stephanie Clifford in the New York Times, whenever a patient clicks "yes" to the multiple opportunities offered during the Real Age questionnaire to "become a member" of the Real Age community. Once a patient says yes to membership, his information becomes part of a database that is then combed to see what pharmaceutical drugs might appeal to the patient.

"It's free," as the Real Age web site keeps reminding people.

But is it really? Patients who are drawn toward a drug by "direct to consumer" pitches like this are likely to sign on for a prescription they may not really need, and every prescription drug carries side effects that may outweigh the drug's benefits. In the early years of a drug's marketing, when manufacturers are most keen on pushing their products, the risks are not fully known to the medical community. That's because the studies done on drugs to win FDA approval are usually limited to a few thousand carefully selected patients.

The safest approach to using prescription drugs is explored by Patrick Malone in his new book, The Life You Save. See chapter 7.

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The U.S. Supreme Court has rejected a strong push by the pharmaceutical industry to win immunity from lawsuits filed by injured plaintiffs. In a 6-3 decision in the case of Wyeth v. Levine, the Supreme Court ruled that the Food and Drug Administration's approval of a drug's label does not mean that the manufacturer has no obligation to improve the warnings on the label if new information comes to the attention of the manufacturer.

This is a big victory for patient safety. The case will help doctors too, by keeping the pressure on the drug manufacturers to keep their product labels up-to-date so that doctors can be educated about the safest way to use drugs. Medical leaders, such as a group of editors of the New England Journal of Medicine, had filed "friends of the court" briefs urging the Supreme Court to take the side of the injured patient.

The heroic patient who pushed this case was Diana Levine, a Vermont musician who lost her arm and her career after being injected too rapidly with an anti-nausea drug called Phenergan. The drug is well known to cause terrible injuries if it gets into an artery. She contended, and the jury and the Vermont Supreme Court agreed, that the drug's manufacturer, Wyeth, knew about this risk and should have warned doctors on the label to avoid the "i.v. push" technique that carried a high risk of inadvertent injection into an artery.

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Posted In: Medical Error , Medications , Product Safety

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In a recent initiative against contaminated weight-loss products, the FDA finds 69 drugs to be contaminated with prescription drugs and chemicals, and expects the list of brands to grow even longer in the next few weeks, reports Natasha Singer of the New York Times. A complete list of the tainted drugs found so far is available on FDA’s website.

One of the best known drugs on FDA’s list is StarCaps, endorsed by many celebrities, which was found to be tainted with bumentanide, a powerful diuretic that can give rise to serious side effects. FDA’s Michael Levy said that many of the products “either contain dangerous undeclared ingredients or…have no effect at all.”

These weight-loss products are not only illegal – FDA considers a supplement unapproved if it contains an undeclared active pharmaceutical ingredient – they also pose dangerous risks for consumers. For one thing, the ingredients on their own can cause problems like elevated blood pressure or seizures. Worse, the hidden ingredients can have toxic interactions with other medications, making it difficult for doctors to diagnose patients or manage their illnesses.

Although many of the distributors of these 69 drugs have voluntarily recalled the products, others continue to sell them on the internet. Consumers taking weight-loss supplements should monitor FDA’s growing list of products they should avoid and consult their doctors for a healthy and safe weight management plan.

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Posted In: General , Medications , Product Safety , Self-care

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Seroquel is an atypical antipsychotic drug used to treat mental illnesses, such as bipolar disorder and schizophrenia. But patients who take Seroquel are 70% more likely to become diabetic than those who don’t take this drug, a risk that the drug manufacturer AstraZeneca was aware of as early as 2000. Joe Schneider and Margaret C. Fisk of Bloomberg.com report AstraZeneca’s release of its internal studies that suggested causal links between Seroquel and “diabetes and related conditions.”

Not only should patients watch out for the increased risk of diabetes that Seroquel and similar drugs (they are in a class called “atypical antipsychotics,” including Abilify, Zyprexa, and others), they need to be aware of the mental illnesses that these drugs are approved to treat. A Reuters article reports that an AstraZeneca sales representative marketed Seroquel as a depression-treating drug to a physician, which is an unapproved use of the drug. Although it is not clear from the article what dangers are associated with treating depression with Seroquel, it is safest to limit use of these powerful drugs to what they're approved to treat.

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Nearly every week, we hear more evidence that American children are over-medicated, especially with drugs that affect mood and behavior. Most recently, a panel of experts has denounced the overuse of Risperdal, a powerful antipsychotic drug, for attention deficit disorder. The drug has too many side effects, including potential development of permanent muscle twitching, to justify its use in mild conditions like ADD for which other options exist, according to the expert panel convened by the Food & Drug Administration to advise it on labeling changes.

What is behind the explosion in use of antipsychotic drugs in children (besides Risperdal, they include Zyprexa, Seroquel, Abilify and Geodon) is a drumbeat of support from leaders in child psychiatry. But that leadership is tainted by their ties to the drug industry -- ties that frequently don't get mentioned in public when these same doctors are lecturing their colleagues and advising worried parents. One leader, Dr. Joseph Biederman, a child psychiatrist at Harvard, was revealed by a Congressional investigation to have accepted $1.4 million from manufacturers of antipsychotic drugs that he did not disclose to his university. Another psychiatrist leader, Dr. Charles B. Nemeroff of Emory, had to step down as chair of psychiatry after it was revealed that much of his consulting pay from drug makers, which totaled over $2.8 million in seven years, had been hidden from his university.

Now another influential psychiatrist has been exposed for his secret ties to the drug industry. He is Dr. Frederick Goodwin, former chief of the National Institute of Mental Health, who hosted a popular show on National Public Radio, "The Infinite Mind." Senator Charles Grassley of Iowa released data to the New York Times showing that Dr. Goodwin received $1.3 million from drug manufacturers from 2000 to 2007 for giving marketing lectures to other doctors. The money was never mentioned on his radio show, and NPR now says the show has been canceled and all reruns will stop soon.

According to the Times' Gardiner Harris, on one day in 2005, Dr. Goodwin received $2,500 from GlaxoSmithKline to give a talk about its mood stabilizer drug Lamictal at a Ritz Carlton resort in Florida. On his radio show broadcast the same day, Dr. Goodwin said that children with bipolar disorder who did not get treatment could suffer brain damage (a controversial prognosis) but he reassured his listeners that mood stabilizer drugs were a safe and effective way to treat the problem.

Senator Grassley has sponsored legislation to require drug makers to post publicly all the payments they make to doctor consultants. That would help the public to know whether the recommendations they see from doctors for medicating their children are truly unbiased or should be taken with a grain of salt.

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Posted In: Disclosure , Doctor-Patient Relationship , Medications

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Millions of people with normal cholesterol levels in their blood could be started on cholesterol-lowering statin drugs based on a new research study, but if patients understood the numbers behind the study, they might not move so fast to put statins in their medicine cabinet. Every patient can benefit from a closer understanding of how statistics work in medicine to push people toward treatments that they may or may not really benefit from.

The latest study involves people who were put on cholesterol-lowering statins because they had a high result on a blood test called C-Reactive Protein, even though the same people did not have high cholesterol.

As reported by Tara Parker-Pope in the New York Times' "Well" blog, here are the key numbers:

* The researchers reported an impressive sounding 50 percent reduction in heart attacks in the group treated with statins, as compared to patients in the same study who got a sugar pill (placebo) instead.

* But the real numbers of actual patients helped by the statins were only around nine in every 1,000 people treated -- less than one percent.

How do those numbers fit together? In the placebo group, 18 of every 1,000 patients suffered a heart attack or some other serious heart event during the study. In the group taking the statin drug, nine of every 1,000 patients had a serious heart event. That's how the researchers could report that the risk had been cut in half -- from eighteen to nine -- although the actual numbers of patients were few. Comparing eighteen to nine is called a relative risk ratio. Comparing 18/1,000 to 9/1,000 is called comparing the absolute risk. The absolute risk number is usually more meaningful.

Another important number for patients to understand in figuring out if a new medicine is for them is called the "number needed to treat." How many patients need to be treated with the new drug for one patient to benefit?

According to a New England Journal of Medicine editorial which analyzed the new study, 120 patients would need to be treated with statins over two years for just one of those patients to benefit.

That number might be enough to persuade some patients to take the drug. But it's a lot different than fifty percent. Bottom line: to make intelligent choices about treatments, patients need to understand how many patients like them are really expected to benefit from the treatment.

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The Institute for Safe Medication Practices, a watchdog group, points out that the number of deaths (4,825) and injuries (21,000) from prescription drugs have reached record levels in the first quarter of this year, representing nearly triple the number of deaths in the last quarter.

The blood thinner heparin and the anti-smoking drug varenicline are the most dangerous, according to the statistics.

And where do these statistics come from? That is the worrying part, because they are probably underestimating the reality of the situation:

The data came from voluntary reports of adverse effects to the Food and Drug Administration, which made the data public after stripping information that identified victims. Because the reporting is voluntary, researchers have speculated that fewer than 10% of adverse events actually makes it into the system.

However, the article points out that since the dangers associated with heparin have been recognized, deaths and injuries have gone down. Varenicline is a different story:

Varenicline remains an ongoing problem, however, according to institute officials. Since the drug -- sold in the United States by Pfizer Inc. under the brand name Chantix -- was approved in 2006, it has been linked to 3,325 serious injuries and 112 deaths.

Some reports were linked to people attempting suicide or causing injury to themselves after using the drug, which can evoke serious psychiatric problems. Others were linked to blackouts, seizures or loss of consciousness, perhaps tied to sudden disturbances in heart rhythm...

...One possible explanation for the link might have been the success of the drug and the large number of people using it, the report said. But investigation showed that, during the quarter, varenicline accounted for more reports of serious injury than the top 10 best-selling prescription drugs combined.

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Posted In: Medications , Product Safety

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We have all looked at the newspaper and noted with interest that some new drug cures 75% of the people who take it.

Some of us may have even based our medical decisions around information acquired in this way, maybe by going to the doctor and asking for that particular drug.

Unfortunately, the study that said the drug was very effective might have been funded by the same people who made the drug--and the article might not have told you that.

From the article:

The mainstream media often fail to report when drug company funding is used for studies of medications, a new review found.

What's more, there's a tendency among both medical and mainstream reporters to use brand names, rather than generic names, when referring to specific medications.

And both of these factors work to skew public and medical opinion toward commercial interests, according to the review, published in the Oct. 1 issue of the Journal of the American Medical Association.

This, despite newspaper editors' assertions to the contrary, the study authors found.

The lead author of the study, Dr. Michael Hochman, argues that everyone should try to refer to drugs by their generic names rather than by their brand names--in order to separate specific drug companies from the discussion of what drug is best for a patient.

Everyone who gets information about drugs from the media should keep this in mind as we read.

It's also a good idea to follow the seven-year rule -- do not take a drug within its first seven years on the market. That is because the injuries and dangers from the drug often don't become well known until it's been on the market for some time. See Public Citizen's Health Research Group web site for a good discussion of practical advice for patients in reducing their risks of harm from drugs.

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Forbes Magazine has an informative article on the frequency of hospitals making mistakes while caring for patients, pointing out that 1.5 million Americans fall victim to such errors every single year.

Some of these errors occur through sheer carelessness: for example, 100,000 people a year die from "superbugs," bacteria that are resistant to available antibiotics. Infections from these superbugs can frequently be prevented by hand-washing. Yet other errors are the system's fault and not the fault of any individual. They occur because of overcrowding and the consequent inability of doctors and nurses to spend sufficient time with each patient.

The article also cites an Auburn University study showing that hospitals administer the wrong drug one time out of five. The dosage of the drug is another common source of error. A famous recent example of a drug error is from last November when actor Dennis Quaid's newborn twins were given 1,000 times the intended dose of the blood-thinner heparin. Luckily the hospital detected the error before permanent damage was done.

What is the bottom line? There are no magical solutions, especially since most of these problems are systemic. As a doctor quoted in the article says: "If you're sick, the best way to avoid getting sicker is to take charge of your care." Asking questions and being unafraid to make demands is the most any individual patient, or their loved ones, can do to reduce risk of error.

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Posted In: Doctor-Patient Relationship , Medical Error , Medications , Standard of Care--Hospitals

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Tara Parker-Pope recently had an article on how fewer and fewer patients trust their doctors.

About one in four patients feel that their physicians sometimes expose them to unnecessary risk, according to data from a Johns Hopkins study published this year in the journal Medicine. And two recent studies show that whether patients trust a doctor strongly influences whether they take their medication.

The distrust and animosity between doctors and patients has shown up in a variety of places. In bookstores, there is now a genre of “what your doctor won’t tell you” books promising previously withheld information on everything from weight loss to heart disease.

What are the reasons for this new distrust? Several factors appear to be involved:

(1) Patients often don't understand what is going on with their health care because doctors and nurses are too rushed to explain things to them. Dr. Sandeep Jauhar, cardiologist and author of Intern: A Doctor's Initiation, is quoted in the article with a story of a patient who was transferred from one hospital to another with no explanation for why. He blamed a "broken system" for such failures to communicate.

(2) There has been greater coverage in the news of medical error, the power of the drug industry and the flaws in health care administration.

(3) The Internet makes information much more available, so patients can be informed skeptics. Drug companies also market directly to patients, so they come into the doctor's office with their own desires and opinions on what medications they should take. The upside to this is that patients have the information to challenge a doctor's errors. The downside is that many end up taking a drug commercial, for instance, at face value and will not listen to a doctor's reservations about the efficacy of a drug.

Again, from the article:

“Doctors used to be the only source for information on medical problems and what to do, but now our knowledge is demystified,” said Dr. Robert Lamberts, an internal medicine physician and medical blogger in Augusta, Ga. “When patients come in with preconceived ideas about what we should do, they do get perturbed at us for not listening. I do my best to explain why I do what I do, but some people are not satisfied until we do what they want.”

The whole article is worth reading. In addition, the article's page also has an embedded video clip of interviews with people discussing their attitudes to their doctors.

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Laura Landro, in her column "The Informed Patient," discusses the problem of adults neglecting to get vaccinated for new illnesses. Not only that, but adults forget or are unaware that some childhood vaccinations lose efficacy after some time and need to be re-done. Skipping pre-travel vaccinations is also a common error.

Part of the problem is insurance: not only is vaccination for the very young more likely to be encouraged, but it is also more likely to be covered by insurance providers.

The whole column is worth a read, but here are some disturbing statistics Landro cites:

-only 2.1% of adults are vaccinated for tetanus, diphtheria and whooping cough, despite the existence of a combination vaccine for all three.

-only 1.9% of adults have been vaccinated for shingles. The shingles vaccine is recommended for all adults over 60.

-only 10% of women from 18 to 26 have received the vaccine for human papillomavirus, which can lead to cervical cancer, and which most insurance providers will cover.

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Posted In: Cancer , Infections , Medical Error , Medications , Vaccinations

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Previously, this blog has discussed the contaminated heparin (a blood-thinning medication) found in the U.S. and linked to deaths and injuries.

Now the Food and Drug Administration has received reports of deaths tied to medical devices that use heparin, although they are not currently sure whether the heparin in these devices is contaminated.

From the article:

The FDA said the majority of the adverse events, which occurred from Jan. 1 to May 14, were associated with the use of heparin-lock flush solutions but also include heparin-coated oxygenators and circuits used during cardiopulmonary bypass procedures.

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After his newborn twins were given near-fatal doses of the blood-thinner heparin, actor Dennis Quaid testified in front of Congress defending consumers' rights to file suit against pharmaceutical companies.

From the article:

Beginning with the Bush administration, the Food and Drug Administration has stepped into suits on the side of defendant pharmaceutical companies, arguing that federal regulation of drugs pre-empts state suits.

The article also reminds us that thousands of people die each year from medical errors. Lawsuits like the one Quaid is filing against Baxter Healthcare Inc. (the maker of the heparin) are one way of holding those who make these errors accountable.

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Tara Parker-Pope of the NY Times has an article on how more than half of the writers of the DSM-IV--the Diagnostic and Statisical Manual of Mental Disorders--have financial links to the drug industry.

The DSM is the most commonly used handbook of psychiatric disorders. Clearly these financial links suggest a conflict of interest.

From the article:

It’s not the first time the D.S.M. has been linked to the drug industry. Tufts University researchers in 2006 reported that 95 — or 56 percent — of 170 experts who worked on the 1994 edition of the manual had at least one monetary relationship with a drug maker in the years from 1989 to 2004. The percentage was higher — 100 percent in some cases — for experts who worked on sections of the manual devoted to severe mental illnesses, like schizophrenia, the study found.

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Oral contraceptives significantly reduce risks of ovarian cancer in women, says a new large-scale study. The pill has been linked to reduction in breast cancer rates as well, but not so large as the reduction in ovarian cancer rates.

The risk reduction persists up to thirty years after a woman stops taking the pill, although it declines with time. The risk reduction is also stronger in women who take it for long periods of time.

Furthermore, as the linked article says:

The proportional risk reduction for every 5 years of use was 29 per cent up to 10 years of stopping use, 19 per cent for 10 - 19 years after stopping, and 15 per cent for 20 - 29 years after stopping.

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Out of nineteen industrialized nations, the U.S. has the most deaths that could have been prevented by access to timely, effective medical care.

Ellen Nolte and Martin McKee of the London School of Hygiene and Tropical Medicine performed the study, looking at deaths before the age of seventy-five caused by numerous diseases and complications. They found that France performed the best by this measure--though France, and other countries that ranked higher than the U.S., spends less money on health care than the U.S. does.

Not only was the U.S. the worst in these rankings, but we Americans are also ranked four places lower than we were in the last study (which covered 1997 and 1998). We are getting worse and spending more money.

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Posted In: General , Medical Error , Medications , Standard of Care--Hospitals , Surgery

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Anti-psychotic drugs such as Haldol and Risperdal were developed to treat schizophrenia, but have recently been used for much broader purposes. They have been used to treat aggression in people suffering from everything from attention-deficit disorder to depression to the intellectually handicapped.

A new study finds, however, that these drugs are no more effective than placebos in treating aggression in the mentally disabled. This suggests that the drugs are being abused, and should be prescribed less often.

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A thirty-year analysis shows that anemia drugs produced by Amgen Inc. and Johnson & Johnson raise the risk of leukemia incidence.

The following drugs are implicated in this study: Aranesp and Epogen (by Amgen Inc.), and Procrit (by Johnson & Johnson).

In addition, the steroid danazol was linked to higher risk of leukemia.

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Shockingly, nursing homes having been giving elderly residents anti-psychotic drugs--not to combat actual psychosis, but rather to quiet symptoms of Alzheimer's or other forms of dementia and make the patients more docile and controllable.

This overuse of anti-psychotics is so rampant that it accounts for why Medicaid has recently spent more money on anti-psychotics than on any other type of pharmaceuticals.

This is not wholly due to malicious intent on the part of the nursing homes, but also on the fact that federal insurance programs are more willing to give money for drugs rather than for the extra staff that are needed to care for elderly patients with dementia.

This report highlights how medical institutions can harm the most vulnerable patients by giving them medications they do not require in order to meet economic or administrative goals.

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Posted In: Medications , Standard of Care--Hospitals

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Acute sinusitis is often treated with antibiotics, and possibly also a topical steroid.

However, a recent study found this common treatment to be no more effective than a placebo.

Commenters on the study have noted that there may be some patients for whom antibiotics might help, but there is no reliable way for a clinician to tell those patients from the others.

It is possible that this result is due to the greater level of resistance to antibiotics that has resulted from increased use of antibiotics over the last few years.

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