FDA To Reconsider Once-Rejected Diet Drug

February 17th, 2012

 

ABC News

 

By: Carrie Gann

 

In the search for treatments to fight obesity, regulators are turning their attention to a diet drug that has already failed to receive government approval as a weight loss treatment.

Next week, a panel of advisors to the U.S. Food and Drug Administration will consider whether or not to recommend the diet drug Qnexa for approval. The move is the latest attempt to give new tools to patients and doctors to fight the obesity that currently plagues one-third of Americans. It also fans a fiery debate about the search for a “magic bullet” alternative to difficult lifestyle changes to help obese people lose weight.

Qnexa was rejected by the FDA in 2010 over concerns about potentially dangerous side effects, such as cardiovascular problems and birth defects. Now, the FDA will consider whether or not the drug’s manufacturer, Vivus, should do a larger clinical trial to investigate the potential for cardiovascular side effects.

But some obesity specialists are, in effect, already giving the drug to their patients by prescribing Qnexa’s two major ingredients, phentermine and topiramate. The practice, called off-label prescribing, is not prohibited by the FDA. Doctors who have prescribed this combination say it has helped patients shed pounds when many other paths to weight loss have failed.

Dr. Ken Fujioka, director of the Center for Weight Management at Scripps Clinic in San Diego, said he often sees obese patients who have changed their diets, started exercising more and still have not been able to lose more than a few pounds. Though bariatric surgery is a lasting, effective option for long-term weight loss, many patients either aren’t morbidly obese enough to qualify for the surgery or are reluctant to resort to such a drastic measure to lose weight. For about 30 of these patients, Fujioka has prescribed low doses of phentermine and topiramate.

“The weight loss with this combination rivals bariatric surgery and I see using these meds in the seriously obese patient as an alternative,” Fujioka said.

Dr. Jana Klauer, a New York City-based doctor specializing in weight management, said her patients lost an average of 40 pounds when taking the drugs along with improved diet and exercise plans.

“The drug combination gives great results, providing diet and exercise are part of the plan,” she said.

Vivus, the company that developed Qnexa, said in a statement that the drug is a combination of low doses of both drugs and it is intended for use in combination with improvements in diet and exercise. Vivus said it does not support the off-label use of phentermine and topiramate.

The drugs work by suppressing appetite, and both have been approved by the FDA for other uses. Phentermine, a stimulant, is already approved for weight loss, but only for short-term use. Topiramate is an anticonvulsant, for which weight loss is a side effect.

But a laundry list of side effects has many experts concerned about the safety of the drugs, if taken over a long period of time. Topiramate creates feelings of mental fogginess, memory lapses and a lack of concentration.

Phentermine, one of drugs that made up the failed diet drug Fen-Phen, can lead to a range of cardiovascular side effects, such as high blood pressure, heart attacks and heart palpitations. Dr. David Katz, co-founder of the Yale University Prevention Research Center, noted that these side effects are the very problems caused by obesity.

Dr. Charles Clark, a professor of pharmacology and toxicology at Indiana University, said the potential side effects are enough to keep him from prescribing phentermine and topiramate to his patients, particularly in light of the failure of Fen-Phen, which was withdrawn from the market in 1997 after causing fatal blood pressure and heart valve problems in patients.

“Given our experience with Fen-Phen, we should be cautious in our use of these agents until larger and longer-term trials are completed,” Clark said.

Others say concerns about side effects of both drugs and their offspring Qnexa are legitimate, but could be managed or avoided if doctors carefully monitor patients while they’re taking the drug. For example, the FDA’s concerns about potential birth defects caused by Qnexa could be resolved by not prescribing the drug to women who could get pregnant. Many doctors say the risks of these drugs may be outweighed by the benefits for some patients with disabling health problems caused by obesity.

In the past 20 years, a parade of diet drugs have come before the FDA, representing an effort by drug companies to give obese patients and their doctors alternatives to difficult, often unsuccessful lifestyle changes. Most of the drugs have failed to meet the agency’s standards for safety and effectiveness. Many come with a list of embarrassing side effects, such as anal leakage, and only one, Alli, is approved for long-term use. A handful of drugs, such as Metabolife and Meridia, were removed from the market because of heart safety concerns.

Some doctors say there is no evidence that Qnexa will perform better than the diet drugs that have already flopped.

“I have made selective use of some weight loss drugs, but have not to date found much reason for enthusiasm for any of them,” Katz said. “I don’t have much for Qnexa.”

Others are more hopeful that Qnexa is different, including Dr. Chip Lavie, medical director of cardiac rehab and prevention at the Ochsner Clinic Foundation in New Orleans. He cites evidence from previous clinical trials that Qnexa helps patients lose a modest amount of weight, which improves their risk factors for diabetes, high blood pressure and other cardiovascular problems. He said cardiovascular and birth defect risks that the FDA cited in its first look at the drug were very slight and “clinically unimportant.”

“Considering the dismal results that many experience with attempted weight loss with diet and exercise, which is always the first choice, and the explosion in the need and use of bariatric surgery, this combination drug should be a major advance, and I hope that it gets approved this time by the FDA,” Lavie said.

 

For The Full Report Go To ABC News

 

Doctors Don’t Tell Patients the Truth About the Treatments They’d Use Themselves

April 12th, 2011

Natural News

By: S.L. Baker

Hopefully, this will never happen to you, but consider this scene: you’ve been diagnosed with a life threatening condition like colon cancer. So you sit down in your doctor’s office to discuss your medical options with your physician and it turns out there are a couple of treatments.

“What would you do, doctor, if you were in my position?” would be a logical question to ask.

And, most likely, you’d expect an honest answer. The trouble is, you might very well not be told the truth.

In fact, according to a survey study published in the April 11 issue of Archives of Internal Medicine, what doctors consider the best choices in treatment for themselves is often not what they tell their patients is best for them.

Here’s how Peter A. Ubel, M.D., of Duke University in Durham, North Carolina, and his colleagues came up with their findings. They surveyed two samples of U.S. primary care physicians. Each group of doctors was presented with one of two clinical treatment possibilities.

For the first scenario, 500 doctors were asked about what sort of treatment they’d recommend if they or one of their patients received a diagnosis of colon cancer. They were given two choices to pick from — both were surgeries they could cure the colon malignancy in 80 percent of patients.

But there was a catch.

One operation had a higher death rate. However, it also had far fewer adverse side effects. On the other hand, the second type of surgery had a lower death rate but a small percentage of patients would be left with serious health problems including chronic diarrhea, intermittent bowel obstruction , a wound infection and/or the need for a colostomy (a surgical procedure that brings one end of the large intestine out through the abdominal wall where stools drain into a bag attached to the abdomen).

Almost half the doctors returned the colon cancer questionnaire and 37.8 percent of them stated that if they had received the cancer diagnosis, they would personally opt for the surgical procedure with a higher rate of death but a lower rate of the serious adverse effects listed above.

On the other hand, the majority of these doctors would have told their patients the operation with a lower death rate but a host of potentially very serious adverse effects was best for them.

The second hypothetical scenario polled 1,600 physicians about how they’d treat patients or themselves if faced with a new strain of avian flu infecting people in the U.S. One group of doctors was asked to imagine they had been infected; the other group was asked to imagine that a patient was infected with this serious influenza.

A single therapy was available for this strain of avian flu — an immunoglobulin treatment. In people with the avian flu who weren’t given immunoglobulin, there would be a 10 percent death rate and a 30 percent hospitalization rate with an average stay of a week. The treatment would reduce the rate of adverse events by half. However, in this scenario, the immunoglobulin therapy would also cause death in one percent of patients and permanent neurological paralysis in four percent of patients.

The avian influenza scenario survey was returned by 698 doctors and a whopping 62.9 percent of them said they’d personally refuse the immunoglobulin treatment when imagining they had been infected, in order to avoid its adverse effects.

But what decision did the docs make when imagining that a patient had been infected with the avian flu? The vast majority stated they’d recommend the immunoglobulin shots.

“Patients facing difficult decisions often ask physicians for recommendations,” the authors stated as background information in the study. “However, little is known regarding the ways that physicians’ decisions are influenced by the act of making a recommendation.”

“In some circumstances, making recommendations could reduce the quality of medical decisions. In at least some circumstances, however, such as when emotions interfere with optimal decision making, this change in thinking could lead to more optimal decisions,” the researchers concluded in their paper.

Curiously, Dr. Ubell and his research team think physicians probably different treatment recommendations for their patients than they would for themselves because of this: “…the very act of making a recommendation changes the way physicians weigh medical alternatives.”

Another common sense alternative explanation could be that doctors are also considering legal ramifications — for example, if they recommend a procedure with a slightly higher mortality rate and the patient dies, a family member might sue.

Whatever the explanation is, one thing is clear. This study is another example of why people should educate themselves about risks and possible benefits of medical treatments and take charge of their own health decisions whenever possible.

Click here for the full report from Natural News

FDA’s Big Drug Problem

September 8, 2010

TIME

by Massimo Calabrese

Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug’s maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company’s $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. The most recent studies of Avandia, the GSK officials told the FDA, had “yielded information that is inconsistent with an increased risk of myocardial ischemic events,” according to sealed court proceedings obtained by TIME.

What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies “strengthens the [cardiac-risk] signal observed in the [previous] analysis.” Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an “increased risk of ischemic event ranging from 30% to 43%!” Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group. (See how to prevent illness at any age.)

But the mixed-evidence argument GSK presented to the FDA worked. After months of deliberation, the agency decided to keep the drug on the market — a move worth billions of dollars to GSK but that also may have put millions of patients at risk.

Such examples of the drug industry’s outmaneuvering FDA regulators are disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring. More than 140 million Americans take at least one prescription drug in any given month, and they rely on the FDA to ensure those drugs are safe. That trust, the story of Avandia illustrates, is a gamble. In July, an FDA advisory group conducted the second hearing on the drug’s safety since its 1999 approval and again concluded that the evidence against the drug was insufficient to pull it from the market. The group instead recommended additional warnings and restrictions on Avandia’s use. In the coming weeks, the FDA will decide whether to take that advice or withdraw Avandia from the market.

Gaming the System
Over the past two decades, as drug after drug has been recalled after winning FDA approval, it has been hard not to wonder if FDA regulators have been captured by the drug industry. FDA critics and industry monitors charge that the drug-approval process is too easy for pharmaceutical companies to game. It is in some ways an unsurprising development. The FDA serves a public insatiably hungry for new medicines. Yet the agency does not have responsibility for performing safety testing. It relies on drug companies to perform all premarket testing on drugs for safety and efficacy. And it relies on industry “user fees” for 65% of its budget for postmarket monitoring of the drugs it approves, thanks to a 1992 law designed to speed treatments to patients. “The FDA’s relationship with the drug industry [is] too cozy,” says Senator Chuck Grassley of Iowa.

Federal studies reveal that the FDA doesn’t have a complete or accurate list of prescription drugs on the market and is missing or has incomplete information on one-third of the drug-safety and efficacy trials under way. Over the past three years, the inspector general at the Department of Health and Human Services found that the FDA had inspected only 1% of clinical-trial sites from 2000 to 2005 and lacked financial disclosure data for clinical investigators in half of all industry drug reviews.

The results of this broken system may prove criminal as well as fatal. In June, FDA whistle-blower Dr. David Graham published an article suggesting that Avandia caused 47,000 more diabetics to suffer heart failure, stroke or death than would have been the case if they had taken an alternative. The risk is especially troubling given that diabetics are already more vulnerable to heart disease because of their condition. Congressional reports revealed that GSK sat on early evidence of the heart risks of its drug. Equally alarming is the revelation that the FDA knew of the dangers months before it informed the public. Now the FDA is investigating whether GSK broke the law by failing to fully inform the agency of Avandia’s heart risks, deputy FDA commissioner Dr. Joshua Sharfstein tells TIME. At the least, the story of Avandia shows how drug companies use uncertainty to their advantage — at a risk to public health.

Risk and Reward
In November 1998, SmithKline Beecham (SB), which more than a year later would merge with Glaxo Wellcome to become GlaxoSmithKline, presented the FDA with an impressive application to market Avandia: dozens of boxes, each containing eight volumes the size of the New York City phone book, filled with trial data and chemical analyses. Avandia, or rosiglitazone, was only the second in a new class of antidiabetes drugs that was showing promise in helping Type 2 patients keep their blood sugar in check. But the first product, troglitazone, or Rezulin, was also causing a troubling amount of liver damage, so doctors and patients were eager for a safer alternative. Aware of this, FDA officials put Avandia on a six-month fast track to approval. As the FDA’s medical, statistical and pharmacological reviewers went through the mountain of documents, they soon found the same thing: Avandia users experienced more cardiovascular issues, including a rise in bad cholesterol (or LDL) and lipids, than those taking other antidiabetes medications or a placebo. But detailed though the pages of data provided by SB were, they didn’t show this danger of heart problems with certainty.

See a quick guide to the FDA.

In public, SB executives defended the safety of their drug. At an April 1999 FDA public hearing featuring outside experts charged with recommending whether to approve Avandia, SB’s head of research and development, Dr. Tadataka Yamada, maintained that Avandia had a “risk-neutral lipid profile” and “cardiovascular safety … comparable to placebo and active comparators.” FDA scientists disagreed. Concerned about the boost in LDL, FDA pharmacologists recommended against approving the drug. Dr. Robert Misbin, the FDA’s medical officer, said he would support approval only if the company committed to a thorough safety trial that would include monitoring for cardiovascular risks.

The hearing committee, three of whose eight voting members had declared financial conflicts of interest in the case, debated the heart issue and eventually recommended that the FDA approve the drug. (TIME requested the forms that waived the conflicts of interest; an FDA official declined to release them and said none of the conflicts involved a relationship with SB.) Then came the horse trading. After outside experts weigh in on a new drug, but before it receives final approval from the agency, the FDA and the drugmaker negotiate which tests the company will perform once large numbers of people are taking it on the open market. (See a video of an athlete with diabetes competing in the Olympics.)

On May 5, 1999, SB sent its proposal for testing Avandia to the FDA. The company didn’t want to do a long-term safety test at all. Less than a week later, in a letter to his superior, Misbin threatened to withdraw his approval recommendation, saying the risk of heart disease may be increased by treatment with Avandia and accusing SB of attempting to divert attention from dangers that Avandia might pose to patients, according to parts of the letter read to TIME.

Then, right at the May 25 deadline for FDA approval, SB made an offer to focus its testing on the drug’s ability, as compared with competitor drugs, to lower blood sugar. It was a side step from the question the agency wanted to answer about the drug’s safety. Instead of focusing on finding out if Avandia posed a heart risk, SmithKline Beecham was going to run a trial its sales representatives could use to promote the drug. “It was really a marketing study,” says Misbin now. But later that day, Dr. John Jenkins, the FDA’s director for new drugs, accepted SB’s proposal for testing the drug on the market and approved Avandia for sale. By agreeing to the company’s version of the postmarket trial, scientists say, the FDA abdicated its responsibility to collect reliable data on Avandia’s safety.

Even with the FDA’s help, the company had its hands full. In 1999, Dr. John Buse of the University of North Carolina at Chapel Hill, a diabetes expert, using slides that SB officials had presented at their approval hearing, did his own calculations based on the data. In speeches, he highlighted the fact that Avandia users experienced a more than fourfold rise in cholesterol compared with those taking a placebo. Because elevated cholesterol levels are a risk factor for heart disease, Buse wrote to the FDA commissioner, warning that Avandia could cause “adverse cardiac outcomes.” In March 2000, officials with the newly merged GlaxoSmithKline got a copy of the letter and, Buse tells TIME, contacted his boss, accusing Buse of being a liar and being for sale, and saying he needed to be muzzled. The company’s stock had dropped, and “they threatened to sue me for something like $4 billion, which was the loss of the company’s valuation,” he says.

In the meantime, the company took measures to promote Avandia. In 2001, GSK worked on an article, later published in the American Heart Association’s journal Circulation by Dr. Steven Haffner of the University of Texas Health Science Center at San Antonio, arguing that the class of drugs that includes Avandia could significantly reduce cardiovascular risk factors in animals. At meetings with doctors in 2001, GSK sales representatives denied Avandia had cardiac side effects, prompting the FDA to issue a public letter of warning against the company.

Keeping the Public in the Dark
By 2004, Avandia sales were earning GSK more than $1.5 billion a year in the U.S. alone. But as more people went on the drug, the picture on cardiovascular risk began to get clearer. GSK began a review of the drug’s heart risks, and in 2005 and 2006 the company produced internal analyses showing 29% and 31% jumps in negative heart events. On May 9, 2006, the company provided these results to the FDA. The agency didn’t immediately release those studies to the public, because its officials “didn’t necessarily agree with some of the methodology used,” says Dr. Janet Woodcock, head of the FDA Center for Drug Evaluation and Research. Instead, the FDA put its own statistician on the job. Just before Christmas that year, Misbin looked at the statistician’s spreadsheet and found that “in virtually every trial, there were more cardiac events with Avandia than with the comparator,” Misbin says. He was convinced enough to call his uncle, who was on Avandia, and advise him to ask his doctor to switch him to another drug.

It was seven years after the drug was approved, and the dangers of Avandia had still not been made sufficiently clear to the public. The FDA was sitting on the new analyses, and GSK, the FDA discovered during an investigation by its inspections unit in the fall of 2007, had failed to report clinical data and other material from 15 tests of Avandia by the end of 2006, according to a March 25, 2008, warning letter to the company. With the company and the FDA maintaining tight control over the full database of information on Avandia’s effectiveness and safety, there was little independent scientists could do to assuage their growing concerns about the drug.

Then came a bit of legal serendipity. As part of a settlement with the state of New York over GSK’s nondisclosure of possible heightened suicide risk among teenagers taking its antidepressant Paxil, the company agreed to put all its recent clinical studies on a website. Aware of the growing concerns among clinicians about the risks posed by Avandia, in April 2007, Cleveland Clinic cardiologist Dr. Steven Nissen Googled the site and downloaded all of the available Avandia trials. After analyzing the 42 trials, he wrote up his findings and in May submitted them to the New England Journal of Medicine. He had found what GSK and the FDA already knew: a 43% higher rate of cardiac events among Avandia patients compared with those taking other drugs or placebos.

By chance, the New England Journal of Medicine chose as a prepublication reviewer of the Nissen article Haffner, the University of Texas doctor who was the lead author on the 2001 paper that had suggested that Avandia’s class of drug could decrease cardiovascular risk. He faxed a copy of Nissen’s article directly to GSK. Now GSK faced the threat of broad public awareness of the hazards of its drug. So with the clock ticking until Nissen’s article was to be published on May 21, 2007, GSK harvested data on cardiac events from the recently completed efficacy trial Jenkins had signed off on back in 1999. Because the trial had been designed to show efficacy, not safety, its cardiac data were inconclusive. (See TIME’s health and medicine covers.)

As it prepared for the pivotal May 16, 2007, meeting in White Oak with FDA regulators, GSK came up with an additional counterattack to Nissen’s study. Unlike the FDA, European regulators had insisted on a long-term cardiac-safety study, called RECORD, when they approved the drug. So GSK argued that the only prudent approach would be to let the RECORD trial run to completion in 2009 to reach a definitive answer on cardiovascular risk. To top agency officials, it seemed like a reasonable solution at the time. But three years and hundreds of millions of dollars in Avandia sales later, it turns out the RECORD trial may not be as reliable a study of cardiac risk as agency officials had hoped.

Regulator, Regulate Thyself
By 2008, after the painkiller Vioxx and the cholesterol-lowering medication Baycol were pulled from the market because of side effects and complications, House and Senate overseers both began investigations of the drug-approval process and the relationship between the drug industry and its federal minders. The Senate Finance Committee concluded in January 2010, after a two-year review, that GSK failed to promptly alert the FDA about Avandia’s drug risks. In response, FDA commissioner Dr. Margaret Hamburg initiated another review of whether to keep Avandia on the market. As part of that review, FDA investigator Dr. Thomas Marciniak presented a devastating report on RECORD’s shortcomings, detailing how the RECORD study minimized Avandia’s heart risks: one death among the drug takers, for example, was missing from the final tally, and discrepancies in some cardiovascular data favored Avandia by a ratio of 4 to 1. The congressional investigation also uncovered e-mails indicating that GSK executives had managed to persuade the trial’s supposedly independent steering committee to publish interim results that demonstrated how inconclusive the heart risk was. The trial’s design, Marciniak found, was “completely inappropriate and biased.”

For its part, GSK insists the drug is indeed safe and says it has played fair with the data. It lists multiple studies that are inconclusive or show no increase in heart risk for Avandia. It says it has disciplined the sales representatives who triggered the FDA admonition; it updated its report on Avandia tests after the FDA’s 2008 warning letter. “GSK continues to stand behind Avandia,” says spokesman Kevin Colgan. “The facts will support our position.” Using the most powerful argument of all, GSK says diabetics desperately want and need drugs to lower their blood-sugar levels. All of this persuaded the FDA advisory group this July to narrowly vote not to pull Avandia off the market, citing a lack of strong evidence that it should be withdrawn. Eleven years after the drug was approved, neither GSK nor the FDA could yet prove Avandia was safe.

GSK certainly had reason to dispel the uncertainty if it could. In 2001, it ran a calculation of what the “net sales downside” would be if the cardiovascular “safety issue intensifies” and found that for 2002‑04, potential lost revenue amounted to $600 million, according to the civil-court proceedings obtained by TIME. GSK reported a 10% drop in profits for the fourth quarter of 2007, partly as a consequence of a drop in Avandia sales following the publication of the Nissen article. Now GSK has other financial concerns. In March the company put aside $3.5 billion for “legal and other disputes.” In May it paid $60 million to settle 700 Avandia civil cases; in July it reportedly offered to pay $460 million to settle civil cases claiming the drug caused heart attacks. GSK declines to discuss the costs of — or anything else about — the investigation the FDA is undertaking against it.

That investigation may indicate that change is coming to the FDA. Government and independent watchdogs say the agency has made some progress. In 2009, government auditors found that the FDA had begun to bolster the role of drug-safety monitors. The Health and Human Services inspector general said last March that the FDA has boosted its prescription database of postmarket reports.

But none of that addresses the issue at the heart of the Avandia case. Science is often inconclusive, and the FDA rightly argues that surveys like Nissen’s are sometimes wrong. Where the FDA fell down on Avandia was in allowing GSK to perpetuate the uncertainty about safety rather than clarify it. In 2007, the FDA gained new powers to require postmarket safety trials, but FDA leaders admit they’re still learning how to use them. Grassley wants to give FDA safety monitors even more power, and former FDA chief Mark McClellan says the agency should use newly computerized medical records to track safety data in near real time.

But with the FDA ever more dependent on industry user fees, and with new drug-safety concerns emerging year after year, it will take more than faster data retrieval to restore the reputation of an agency that was once synonymous with trust in the public mind. The FDA will have to start forcing companies to be transparent and call them out on it when they’re not. Says the medical reviewer Misbin: “Companies are always going to present their best face. It’s our job to say no.” In that sense, the FDA just needs to perform the task it was charged with more than 100 years ago: protecting the public interest by keeping industry honest.

Click here to read the full report

Patient Waits 24 Hours In Waiting Room, Dies Over Blood Clot

June 15, 2010

Natural News

By David Gutierrez

(NaturalNews) A New York City hospital where a Jamaican immigrant died from a blood clot after waiting nearly 24 hours to be seen has agreed to a legal settlement that will place it under federal supervision for five years.

Kings County Hospital (KCHC) in Brooklyn came under state and federal investigation after 49-year-old Esmin Green died on the hospital’s waiting room floor. The scandal broke when security footage was released that showed at least two separate hospital employees looking at her lying there then ignoring her.

A federal investigation uncovered widespread abuse, negligence and malfeasance in the hospital’s mental health ward.

Click here for the full report.

Psychiatrist Held in Stabbing of Woman

February 24, 2010

Cincinnati.com

By Brenna Kelly

A psychiatrist has been charged with stabbing a woman at his Covington office Sunday night.

Douglas Rank, 51, of Golf Manor, was being held Monday in the Kenton County jail where he is charged with first degree assault.

About 7:45 p.m. Sunday, Covington police responded to the third floor of 12 W. Pike St. for a report of an assault with injuries, said Covington Police spokesman Spike Jones.

When police arrived they found Misty Luke, 32, in the doorway with stab wounds to her chest, Jones said. She was taken to University Hospital with serious injuries, he said.

Rank was inside being held by witnesses, Jones said. He was taken into custody and police recovered a sword that they believe to be the weapon, Jones said.

Police were investigating the incident Monday and had not determined the relationship between Rank and Luke, Jones said. He did not know whether she was a patient.

Rank is being held in lieu of $50,000 cash bail. He is listed in jail records as living in Cincinnati, and Hamilton County Auditor records show he owns a home on Stover Avenue in Golf Manor.

According to the Kentucky Board of Medical Licensure, Rank’s license is active this week, but is it set to expire on Sunday.

He graduated from Baylor College of Medicine in Houston in 1984, according to state records.

Rank, who is also board certified in internal medicine, had his license to practice medicine restricted by the board in 2001 it found that after he prescribed “high doses of narcotic prescriptions” to one patient while practicing in Lexington.

The Board of Medical Licensure found that Rank given the patient 57 prescriptions over 14 months. Rank agreed to no longer treat the patient.

Rank also faced disciplinary action from the board in 2000 after he admitted he had sexual intercourse with another patient.

Click here for the full report.

Most Patients Unaware of What Drugs They Are Taking

January 18, 2010

Natural News

By Mike Adams

A recent study published in the Journal of Hospital Medicine has revealed that nearly all hospital patients do not know what drugs are being administered to them. The research revealed that nearly half think thought they were receiving one type of medication when they were actually receiving another and only four percent were able to identify at least one drug they received during their time there.

Researchers from the University of Colorado at Denver’s School of Medicine conducted the study to evaluate whether or not hospital patients understood what treatments they were receiving while under professional medical care. Each participant claimed to be aware of his or her outpatient medications and all were coherent and reasonably informed. What the study revealed was that most patients do not know what drugs they are being given and the few that care to or believe they know are often misinformed.

About one in five hospital medication treatments was also found to be wrong, with either an improper dosage or an incorrect drug being administered. Since the patient is the last stop before a drug is administered, researchers are stressing the importance of patient awareness concerning drug therapies in order to avoid grave errors that could inflict serious harm.

Once out of the hospital, less than 15 percent of patients over age 65 could identify the medications they were told to take. Only 40 percent of those under 65 could properly identify theirs.

Study authors believe that increased patient responsibility and awareness about given and prescribed treatments is necessary in order to prevent medical errors and their potential for serious injury.

Comments by Mike Adams, the Health Ranger
This research reveals the sad, sad state of western health care. The statistic that one in five medication treatments were incorrect is nothing short of astounding. That means 20% of the drugs patients are given in the hospital are either the wrong drugs or the wrong doses.

Astonishing. No wonder so many people die in hospitals!

The other part of this research is just as startling: Most patients didn’t even know what drugs they were being given! This speaks to the incredible dis-empowerment of patients in a western medical setting. When patients don’t even know what medicines they’re being given, it puts all the power in the hands of doctors and medical staff. And this study demonstrates that even medical staff all too frequently make mistakes that can be deadly.

The bottom line is obvious: Don’t go to a hospital except as a last resort. Hospitals are dangerous places where frequent mistakes can easily lead to you being harmed or killed by carelessly-administered pharmaceuticals.

And don’t expect to be kept informed of what’s happening to you at the hospital, either. Real communication between doctors and patients is virtually nonexistent (because they’re too busy to spend more than about two minutes with each patient).

Click here for the full report