Posts Tagged ‘medications’

Deadly Super Bugs on the rise.

Wednesday, April 13th, 2011

Health scares are common and are many times overblown. However, the evolution of bacteria that are resistant to antibiotics (dubbed Super Bugs) is a very real and growing danger. Yahoo Health is reporting that two especially dangerous bacteria – MRSA and CRKP – are becoming resistant to all but the most advanced antibiotics, which is posing a major health threat.

Klebsiella is a common type of gram-negative bacteria that are found in our intestines (where the bugs don’t cause disease). MRSA (methacillin-resistant staphylococcus aureus) is a type of bacteria that live on the skin and can burrow deep into the body if someone has cuts or wounds, including those from surgery.

The reason for this new resistance is likely over-use (which includes mis-use) of antibiotics by health care providers (with likely some contribution from use of antibiotics in animals). For a few years now, there has been a growing recognition that doctors are over-prescribing antibiotics, i.e., routinely prescribing antibiotics when they are not necessary. For example, in 2005, U.S. News reported a Harvard study that revealed that doctors routinely prescribed antibiotics for sore throats in children when they were not indicated. A 2007 study indicated that Dutch doctors (whom are generally considered more careful in their use of antibiotics) routinely prescribed antibiotics for respiratory tract infections when they were not indicated.

The Problem with “Overuse”

The danger this poses is that antibiotics – even effective ones – typically leave some bacteria alive. These tend to be the stronger or more resistant bacteria, which then leads to the development of more and more resistance. This occurs in a single individual body in which a patient may have less response to an antibiotic after earlier use of that same antibiotic, but because of the easy spread of bacteria in our world, it also occurs on a global scale. For certain strains of bacteria, doctors are becoming hard-pressed to treat these infections.

CRKP – worse than MRSA?

Thankfully, MRSA is still responsive to several antibiotics so it is still considered a treatable infection. CRKP, however, is of more concern because it is only responsive to Colistin, which can be toxic to the kidneys. Therefore, doctors have no good options when treating CRKP. While so far, the risk of healthy people dying from MRSA and CRKP remains very low, the most vulnerable of us (the elderly and the chronically ill) remain at risk because of their lowered immune system and because the elderly are in nursing homes or other long-term care facilities where infections tend to spread more easily than in the general community.

CRKP has now been reported in 36 US states—and health officials suspect that it may also be triggering infections in the other 14 states where reporting isn’t required. High rates have been found in long-term care facilities in Los Angeles County, where the superbug was previously believed to be rare, according to a study presented earlier this month.

It is essential that we rein in the casual use of antibiotics before we are left with infections that have no cure. Doctors must be better trained to know when antibiotics are necessary and when they are not. For example, antibiotics are useless against viruses (such as the common cold), but how many of you have been given an antibiotic by a doctor “just in case” or because your symptoms have gone on slightly longer than a typical cold would last? It is unfortunately a more common occurrence than we realize. The past success of antibiotics has naturally led doctors to want to give them to patients to relieve suffering. No one wants to turn down a patient who is seeking relief.  However, it makes no sense to give antibiotics to a patient who has no bacterial infection or whose illness will clear up on its own.

Patient Awareness is key

The problem, however, is more than just educating doctors. Patients share some blame too. We – the public – need to learn that antibiotics are not always needed, which can be a difficult lesson to learn when we’re sick. Everyone knows that antibiotics are a quick and effective remedy against common bacterial infections. Antibiotics have saved countless lives over the years and have relieved untold human suffering. So naturally, when we are sick (or our child is sick) and we go to the doctor, we want to see results. We want something that will alleviate the pain and symptoms, not simply be told to wait for the illness to run its course. Sometimes, however, that is the best course when you consider the side-effects of antibiotics and the dangers of over-use. That being said, who wants to hear that when you’re in pain and want relief? It is very easy to demand of doctors that they use all available means to treat a sick child. Doctors need to be able to stand-up to patients and educate them on why antibiotics are not necessarily the best course of treatment in a specific situation.

Don’t kill the good ones!

Doctors also have to teach patients that antibiotics are not targeted killers.  The body contains a lot of good bacteria that are vital to our body’s functioning.  Antibiotics kill those bacteria as well, which some researchers believe can adversely affect health by allowing harmful bacteria to proliferate.  (If you have seen “probiotocs” advertised on certain food products – like yogurt – that is an attempt to introduce good bacteria back into your body.).

Some basic steps to take

In order to protect yourself (or a loved one), good hygiene remains the most effective method of remaining infection-free.  Thankfully, neither MRSA or CRKP are transmitted through the air.  They are typically transmitted through person-to-person contact, or else through hospital equipment such as IV lines, catheters, or ventilators.  If you have a loved one in a hospital or nursing home, be vigilant with your hand-washing and those of the healthcare providers caring for your loved one.

Also, if you are a patient who has been prescribed antibiotics, follow your pharmacist’s orders scrupulously and take the medication in the proper dosage and for the proper amount of time.  Stopping antibiotics too soon can leave bacteria alive, which contributes to the evolution of more resistant bacteria.  You may feel better and want to stop the medication, but it is important to take the full dose.

So – now that you know the risks of over-using antibiotics, are you willing to forego antibiotics when you are sick in order to do your part for the greater good?

UPDATE: (Editor – Brian Nash) Within an hour of posting Mike Sander’s blog on MRSA (and CRKP), I came across a tweet about Manuka Honey is being used for dressings to fight the spread of Super Bugs – particularly MRSA.

Researchers now believe that it can also put a stop to the rates at which superbugs are becoming resistant to antibiotics.

Anyone know of this practice being used in your area hospital or clinics? Does anyone know if this really works? If so, most interesting and useful. Here to spread the word – how about you spreading it too?

Follow-up Blog: Important questions and answers on Pradaxa

Monday, January 10th, 2011

Some months ago, we published a blog to announce what we thought was important medical news about a new product called Pradaxa. That blog, entitled A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?, was widely viewed by many readers since October, 2010. Following our posting, a number of those readers have sent us questions about this new drug. To better serve our readers, we have invited Dr. Steven M. Davis to be our guest blogger on Pradaxa, and to answer some of these important questions.

Dr. Davis is the Associate Professor of Pharmacy at the Campbell University College of Pharmacy and Health Sciences in Buies Creek, NC. He is also the Clinical Coordinator for Pharmacy Services at Wake Forest University Baptist Medical Center in Winston Salem, NC. Dr. Davis has a PharmD with a specialty certification in geriatric pharmacology.

Below are the most frequently asked reader questions:

  1. How does Pradaxa differ chemically to Coumadin (Warfarin)?
  2. Do things with high Vitamin K (like spinach, lettuces, and broccoli) interfere with Pradaxa?
  3. If one were to start Pradaxa, how long would it take the blood to thin? If one were already taking Coumadin (Warfarin), what is the recommended method of switching to Pradaxa?
  4. How long would it take to reverse the effects of Pradaxa? I have been told Coumadin (Warfarin) stays in the body and before any surgery a patient has to wait 5 days.
  5. Why doesn’t the blood coagulation need monitoring if Pradaxa thins out the blood? Why wouldn’t the blood protime (PT) need monitoring with Pradaxa?
  6. How would someone adjust Pradaxa to keep the protime (PT) at a desired level?
  7. Are there any restrictions to other medications such as Aspirin?

Dr. Davis’ responses are listed below:

Question 1: Pradaxa (Darbigatran) is a direct thrombin inhibitor.  Thrombin is one of many clotting factors in the body necessary for coagulating blood.  Coumadin (Warfarin) works by a completely different mechanism. Coumadin/Wafarin prevents the activation of 4 clotting factors that depend on Vitamin K .

Question 2: Since Pradaxa works by directly inhibiting the clotting factor thrombin, the amount of vitamin K in the diet does not matter.

Question 3: When switching from Coumadin to Pradaxa, a physician will usually wait for a patient’s INR to drop below 2 before starting Pradaxa.  In most patients taking Pradaxa, blood will be appropriately thinned 2 to 3 days after starting the medication.

Question 4: Pradaxa is still a blood thinner and care must be used before surgery.  Pradaxa has a shorter life in the body (that is why it is dosed twice daily) and it is cleared from the body quicker than Coumadin (Warfarin).  It is recommended that a patient discontinue Pradaxa 1-2 days before surgery if they have normal kidney function and 3-5 days if they have impaired kidney function.  Of course you would NEVER stop this medication without consulting your physician first.

Question 5: Prothrombin time (PT) and INR measure the ability of Coumadin (Warfarin) to prevent the activation of the Vitamin K dependant clotting factors.  Again, since Pradaxa does not affect these factors, the prothrombin time does not change and, therefore, does not need to be monitored.

Question 6: The biggest advantage to Pradaxa is that there are fewer drug interactions, less food/drug interactions (Vit K containing foods), and thus no need to monitor prothrombin time or INR.

Question 7: Combining Pradaxa with aspirin will increase a patient’s risk of bleeding.  Both medications are used together frequently but ONLY under the direction of a physician.

Dr. Davis offers the following advice to patients considering taking or taking the drug Pradaxa.

This is a new medication and as with all new medications, it has not been used in a large population of patients yet.  New side effects and drug interactions may be discovered as this drug is used more frequently.  The Food and Drug Administration (FDA) monitors these reports and will issue statements as necessary.

From Brian Nash: I want to take this opportunity to thank Dr. Steven Davis for providing us with this information for our readers.

To our readers: Please keep in mind that we, at Nash & Associates, are not physicians. While Dr. Davis was so kind to provide the information he did regarding Pradaxa, this is not the usual approach we would take to our blog postings. From time to time we try to make you aware of important and/or interesting medical news. However, if you have questions about Pradaxa, we strongly urge you to speak with your personal physician.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Drug information found lacking

Thursday, August 19th, 2010

Millions of people take daily or weekly medications for a variety of health concerns.  As we all know, each prescription we get comes with a leaflet or other print-out from the pharmacy that explains what the drug is, how it is to be taken, what the side effects are, etc.  The National Institute of Health and Reuters Health are reporting a new study that raises serious questions as to how useful and effective these leaflets actually are.

Dr. Carole Kimberlin and her colleagues at the University of Florida, Gainesville, studied product leaflets on two common medications:  lisinopril (a blood-pressure medication sold as Prinivil and Zestril) and metformin (a diabetes drug sold as Glucophage and Fortamet).  The study found a “great deal of variance” among the various leaflets, including substantial differences in word count, content, and readability.  The reason for these variances?  Unlike prescription labels, which are subject to strict FDA regulation, the leaflets provided by pharmacies are not.  The FDA only provides recommendations for leaflets.  Private publishing companies actually provide the content for leaflets and the pharmacy then decides what information to put on its leaflet, as well as the format of the leaflet.

The differences found by Dr. Kimberlin were striking.  Word counts on leaflets for the same medication ranged from 30 words to 2,500, with a corresponding difference in the amount of drug content contained on each leaflet.  Only three percent of leaflets for the drug lisinopril met at least 80% of the FDA’s recommendations of usefulness criteria.  Only one leaflet for metformin met this same criteria.  The study also found lacking the amount of information related to drug interactions, i.e., how the medication may react to other drugs the patient is taking.

While the differences in content were significant, the study found that even greater differences existed in readability.  It is up to each pharmacy to format its leaflets so there can be large differences in the size of type, the spacing of the text, and general visual clutter – including store ads or coupons.  All of this can make deciphering these leaflets even more difficult.

In general, Kimberlin told Reuters Health, the biggest shortcoming was in the leaflets’ readability. On average, leaflets from all pharmacies met less than half of the criteria for “comprehensibility/legibility.”  For example, Kimberlin said, the content should be written at sixth- to eighth-grade reading level, but only 10 percent of lisinopril and 6 percent of metformin leaflets met that standard.

The bottom line – carefully read the product leaflet that comes with your prescription.  And if you have any concern about the drug’s usage, side-effects, drug interactions, etc., be sure to talk to your pharmacist or doctor directly.  You may not be able to rely on the information contained in the product leaflet.


Stevens-Johnson Syndrome: one mother’s plea to ‘get the word out’ and one son’s story of horror.

Sunday, July 25th, 2010

Last week I wrote a blog based on a report in USAToday about how many doctors and parents – primarily the latter – are likely to avoid giving their children pain medication when it’s prescribed and needed.

Within minutes of posting this piece, I received a reply on Twitter from a woman who seemed to take exception to the blog or at least wanted me to be aware of the potential dangers of using pain medication in children. Specifically, she wanted me to be aware of what had befallen her son after he had taken Motrin – he was stricken with a horrible condition known as Stevens-Johnson Syndrome.

After communicating back and forth with her that day and going to her blog about her son’s coming home from the hospital following his treatment, I asked her if I could use her son’s story as the nucleus for a blog on Stevens-Johnson Syndrome and how medication can be a cause for this potentially fatal problem. She told me this would be fine since she wanted to get the word out about Stevens-Johnson Syndrome and the role medications can have in its development.

What is Stevens-Johnson Syndrome?

Rather than paraphrase the experts on what this syndrome is, here’s how the Mayo Clinic defines it online.

Stevens-Johnson syndrome is a rare, serious disorder in which your skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed.

Stevens-Johnson syndrome is an emergency medical condition that usually requires hospitalization. Treatment focuses on eliminating the underlying cause, controlling symptoms and minimizing complications.

The authors then note that it can take “weeks to months” to recover from Stevens-Johnson Syndrome. If it’s determined that it was caused by a medication, then “you’ll need to permanently avoid the medication and all others related to it.”

What are the risk factors?

While Stevens-Johnson Syndrome (SJS) is a rare and unpredictable condition, certain factors can increase a person’s risk to suffering this complication: viral infections (such as the common cold), HIV and systemic lupus erythematosus (SLE) – relative compromises of the body’s immune system. It is also reported that if you carry a gene known as HLA-B12, you may be more susceptible to SJS. Some claim that people of Asian ancestry are at increased risk if taking certain medications (Carbamazepine (Tegretol); screening for such special susceptibility is available, according to some reports.

How sick are people who suffer from SJS?

They typically require hospitalization in an intensive care unit. As mentioned, the treatment can take weeks to months.

How is it treated?

There is no known treatment other than supportive care in the form of fluid replacement, skin care and medications to treat the symptoms (e.g. antihistamines for itching, steroids for inflammation of your skin, pain medication and the like) and to prevent the progression of SJS by giving immunoglobulin intravenous (IGIV) therapy to improve and bolster the patient’s immune system.

What areas of the body are affected by SJS?

According to an article published on emedicine.medscape.com:

SJS typically involves the skin and the mucous membranes. While minor presentations may occur, significant involvement of oral, nasal, eye, vaginal, urethral, GI, and lower respiratory tract mucous membranes may develop in the course of the illness. GI and respiratory involvement may progress to necrosis. SJS is a serious systemic disorder with the potential for severe morbidity and even death (my emphasis).

What is Toxic Epidermal Necrolysis (TEN) and what is the difference between SJS and TEN?

SJS is often discussed in the same literature that relates to the another condition known as Toxic Epidermal Necrolysis (TEN). While there is some disagreement among those in medicine, a number of experts consider SJS and TEN to be expressions of erythema multiforme.  Often the conditions are commonly referred to as SJS/TEN. One definitional classification differentiates the two conditions in this manner:

  • Stevens-Johnson syndrome – A “minor form of TEN,” with less than 10% body surface area (BSA) detachment
  • Overlapping Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) – Detachment of 10-30% BSA
  • Toxic epidermal necrolysis – Detachment of more than 30% BSA

What are the causes of SJS/TEN?

While opinions vary, the causes are often listed as (1) infectious, (2) drug-induced, (3) malignancy-related, and (4) idiopathic (unknown). Some report that more than half the patients with SJS/TEN have had a recent upper respiratory tract infection.

What medications can cause SJS/TEN?

SJS and TEN are often associated with taking certain forms of medications: NSAIDS (non-steroid anti-inflammatory drugs -), Allopurinol, Phenytoin (Dilantin), Carbamazepine, barbiturates, anticonvulsants, and sulfa antibiotics (common examples - Septra®, Bactrim® and Pediazole®).

What race, sex and age groups are most affected?

Caucasian males between ages 20 and 50. (Source: emedicine.medscape). Needless to say, this group is simply identified as the most statistically likely to suffer from SJS/TEN. For example, the ratio is 2:1 for men; children as young as old as three (3) months of age have been diagnosed with this dreaded condition. Some claim that African-Americans and Asians are at increased genetic risk for SJS/TEN. One wonders – are these statistics really helpful in making a diagnosis?

What are the signs and symptoms of SJS/TEN?

Once again, relying on the experts at the Mayo Clinic, here is a list of some of the signs and symptoms:

  • Facial swelling
  • Tongue swelling
  • Hives
  • Skin pain
  • A red or purple skin rash that spreads within hours to days
  • Blisters on your skin and mucous membranes, especially in your mouth, nose and eyes
  • Shedding (sloughing) of your skin

If you have Stevens-Johnson syndrome, several days before the rash develops, you may experience:

  • Fever
  • Sore throat
  • Cough
  • Burning eyes

How many people affected by SJS/TEN die?

Mortality is determined primarily by the extent of skin sloughing. When BSA sloughing is less than 10%, the mortality rate is approximately 1-5%. However, when more than 30% BSA sloughing is present, the mortality rate is between 25% and 35%, and may be as high as 50%. Bacteremia/sepsis may also contribute to mortality. (See source)

What is the lesson, if any, learned?

Needless to say, this posting is not in any way intended to be a full-blown medical research article on SJS/TEN. Having heard this mother’s story of her son’s fight to overcome the ravaging effects of SJS, his continuing problems with scarring and her concern that such might befall some other parent’s child, I decided to simply “get the word out” on this little known but horrible syndrome.

Where does the answer lie on this issue of medications? How does one assess the risks versus the benefits of taking medication? I don’t purport to have the answers to these questions. Be aware of the risk; be aware if you are in a risk group; be aware of the signs and symptoms.

Seek immediate medical care if you believe you are having an adverse reaction to a medication.

While there is no magic pill or cure, immeidiate supportive medical management and care in a proper facility are essential to minimizing the ravaging effects of the syndrome. As noted by many medical authors, since SJS/TEN is such a relatively rare disorder, it is many times not diagnosed in a timely fashion. If you suspect that what you are seeing is SJS or TEN – even as a lay person – raise the issue with your treating physician. Remember – early, effective intervention is your best chance to arrest the progress of this horrible condition.

Many thanks to my new friend on Twitter, who brought this issue to my attention and let me use her son’s story to “get the word out.” Speedy and complete recovery to you, Andrew!

FDA reports says Avandia can hurt heart: NY Times investigative report

Saturday, February 20th, 2010

From a report in Yahoo News, which is the source for this posting  - FDA reports says Avandia can hurt heart: report:

According to a report by the NY Times yesterday, February 19, 2010, Confidential U.S. government reports recommend that GlaxoSmithKline Plc’s diabetes drug Avandia be pulled from the market because it can hurt the heart.

Two authors of the report, Dr. David Graham and Dr. Kate Gelperin of the FDA, both concluded that it should be removed from the market.

According to Yahoo News, Sales of Avandia, once Glaxo’s second biggest-selling product, plummeted two years ago after a U.S. study linked it to an increased risk of heart attack in a conclusion disputed by Glaxo.

According to the Times reporter, Gardiner Harris, an FDA advisory board voted, 8-7, in 2007 to accept the advice of an independent committee that while Avandia might increase the risk of heart attack, it should stay on the market.

A U.S. Senate investigation into the product “said Glaxo failed to warn patients earlier that Avandia was potentially deadly” – according to the Times report.

The Times said the internal FDA findings reflected a fierce debate inside the agency about Avandia. The newspaper quoted Glaxo as saying it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” heart attack risk.

At the end of last year, Dr. Janet Woodcock, director of the FDA’s drug center, wrote an internal memorandum that “there are multiple conflicting opinions” about Avandia and ordered officials to assemble another advisory committee to reconsider if the drug should be sold.

The Times quoted FDA Commissioner Margaret Hamburg as saying on Friday, “I await the recommendations of the advisory committee.”

FDA and International Serious Adverse Events Consortium Complete Third Data Release

Saturday, February 20th, 2010

Do you know what ‘adverse event reporting’ is all about?  Well, in case you don’t, here it is – as defined by the Food and Drug Administration (FDA):

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

Yesterday, February 19, 2010, the FDA issued a news release -Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release – concerning data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).  This consortium report was the product of the combined efforts of the U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC).

The concept behind their efforts is the identification of genetic factors  in a subset of patients and thereby assist researchers to better predict an individual’s risk of developing these serious complications.

Drug-induced liver injury occurs in a small subset of patients and is often associated with a drug that is an unpredictable liver toxin, and may be the cause of acute liver failure in some patients. Although the exact mechanism behind drug-induced liver injury is unknown, research suggests that a person’s genes contribute to their likelihood of developing this injury.                                                                                    

Drug-induced SSRs, such as Stevens-Johnson, present as allergic-like skin reactions (blistering and peeling of the skin) and are considered serious enough to discontinue treatment with the medication. These reactions can be fatal if the signs and symptoms are not quickly recognized.

“FDA is pleased with the Consortium’s progress,” said ShaAvhree Buckman, M.D., Ph.D., director of the Office of Translational Sciences in the FDA’s Center for Drug Evaluation and Research. “The continued accumulation of scientific information on the genetic basis of adverse drug events provides researchers with invaluable tools for understanding why some people respond to medicines differently than others.”

If you have ever seen or read about a person suffering from a condition such as Stevens-Johnson Syndrome (SJS), you can well appreciate the significance of this research project.

Use Of Acetaminophen In Pregnancy Associated With Increased Asthma Symptoms In Children

Saturday, February 6th, 2010

Medical News Today recently issued a report on a study, done by the Columbia Center for Children’s Environmental Health at Columbia University’s Mailman School of Public Health, in which children who were exposed to acetominophen (Tylenol) prenatally were at increased risk to have asthma symptoms by age 5.  Use Of Acetaminophen In Pregnancy Associated With Increased Asthma Symptoms In Children.

While the study involved 300 African-American and Dominican Republic children living in New York City, the potential relevance for broader concern for African-American and Hispanic children  is evident.

[The study] found that the relationship was stronger in children with a variant of a gene, glutathione S transferase, involved in detoxification of foreign substances. The variant is common among African-American and Hispanic populations. The results suggest that less efficient detoxification is a mechanism in the association between acetaminophen and asthma.

“These findings might provide an explanation for some of the increased asthma risk in minority communities and suggest caution in the use of acetaminophen in pregnancy,” says Matthew S. Perzanowski, PhD, assistant professor of Environmental Health Sciences at the Mailman School of Public Health.

What is of some related interest is the fact that online postings regarding acetaminophen suggest that this may be the drug of choice for conditions as short-term fever and minor pain during surgery.

For example, Medicinenet.com’s posting, (which certainly predates this study) states in pertinent part:

SIDE EFFECTS: When used appropriately, side effects with acetaminophen are rare.

This most recent study appears to have some similarity to a prior study, at least according to the article on Medical News Today:

In a similar study conducted in the UK, the frequency of acetaminophen use during pregnancy and the magnitude of association in the UK study were similar to that in New York City.

So – Moms-To-Be, consider discussing this study with your OB before reaching for that bottle of Tylenol.

Boston Anesthesiologist Charged with Fraud: The United States Department of Justice – United States Attorney's Office – District of Massachusetts

Monday, January 18th, 2010

This past Friday, January 15, 2010, the FDA issued an announcement regarding a criminal information/charge being filed by the United States Department of Justice against Dr. Scott Reuben.  The details of the charge are contained in the official announcement of the DOJ - The United States Department of Justice – United States Attorney’s Office – District of Massachusetts.

In essence, here is the nature of the charge:

The Information alleges that REUBEN solicited and obtained research grants from pharmaceutical companies to perform research studies on pain management, often associated with various surgical procedures, but that he did not actually perform the research studies. Instead he made up patient data, submitted it to medical journals and caused false articles to appear in a number of medical journals.

If convicted on this charge, REUBEN faces up to 10 years imprisonment, to be followed by 3 years of supervised release and a $250,000 fine.

As the DOJ correctly notes, this is only a charge against Dr. Reuben.  To use its words, “The details contained in the Information are allegations. The defendant is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.”

It does make you wonder, however, just how carefuly so-called ‘peer reviewed’ articles and research papers ARE scrutinized and ‘reviewed.’

FDA announces research program for prescription drugs in pregnancy

Saturday, January 2nd, 2010

On December 30, 2009, the FDA announced that a new collaborative research program to study the effects of prescription medications taken by women during pregnancy.  This program is called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) and will be a collaborative effort among the FDA, and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.

The FDA references in its announcement an article in the American Journal of Obstetrics and Gynecology, which states  that it estimates that two-thirds of women who are pregnant take at least one prescription medication during their pregnancy.

One might think that there had been a number of clinical trials relating to medications taken during pregnancy prior to this collaborative effort; however, this appears not to be the case since there were too many concerns about the health of the mother and fetus preventing such a study in the past.

For more details  on this long-overdue research study, see the FDA’s announcement.