It has now been more than a year since the DePuy ASR implant was recalled due to an alarmingly high rate of failure of the device, which was first documented in Australia and Europe years ago, at a time when the hip implants enjoyed continued strong sales in the United States.

For tens of thousands of patients, the past 15 months or so have been ones filled with extreme anxiety, pain, and frustration because of the following:

• Receiving countless empty promises, significant delays, and the proverbial “run around” from the Broadspire “claims program,” which has been far more kind to surgeons and healthcare providers with unpaid bills than to injured patients.
• Experiencing significant fear and apprehension over blood tests showing elevated levels of cobalt and chromium in their bloodstream, without any clear answers as to what harm this might cause them over time and what can be done about it.
• Enduring yet another painful hip implant revision surgery.  In some cases, within mere months of their original surgery (at which time, they were promised by DePuy that they would not have to undergo this ordeal for 15 years or more due to the alleged proven performance and superiority of the DePuy ASR and other metal-on-metal hip implant products over traditional ceramic and plastic liners).

Thousands of patients have suffered significant complications and have had less than favorable outcomes due to the trauma of extra procedures, complications stemming from metallosis and inflammatory reactions to the metal-on-metal surfaces, pseudotumor formation, infections, and other serious side effects.

Thankfully, scientists are working to answer questions that DePuy should have answered long before their first DePuy metal-on-metal device was implanted in patients.  Several studies have been recently published that help to expand the understanding of the systemic reaction that is triggered by metal-on-metal implants in patients as well as why these devices are failing at alarmingly high rates.  The recent most findings by scientists are:

• Cobalt and Chromium Ions Reduce Human Osteoblast-Like Cell Activity In Vitro, Reduce the OPG to RANKL Ratio, and Induce Oxidative Stress, published in the Journal of Orthopaedic Research, on October 24, 2011 – This study focused on how elevated levels of cobalt and chromium in the blood reduce the number of osteoblast-like cells and essentially impair the body’s ability to normally regenerate and maintain healthy bone.  Ultimately, the authors concluded that patients with elevated levels of chromium and cobalt in the blood are at risk for impaired bone health and that consideration should be given to removal of their metal-on-metal hip implants, even when x-rays and other evidence indicate that the DePuy ASR or other metal-on-metal implants are properly positioned without solid evidence of loosening.

• Corrosion Fatigue of Biomedical Metallic Alloys:  Mechanisms and Mitigation, published in the Acta Biomaterialia, in 2011 – This highly complex medical article from Brazil includes a review of the professional literature that has been published around the world on the scientific explanation for the widespread premature mechanical failure of metal-on-metal hip devices due to corrosion.  The study focuses on a number of different metals and alloys including titanium, surgical-grade stainless steel, cobalt, chromium, and magnesium.  The study also focuses on wear patterns, development of fatigue cracks, pitting corrosion, and formation of crevices at the taper junction, which allow infiltration and pooling of bodily fluids that induce corrosion and cause the release of metallic ions.  The processes of corrosion and metal fatigue combine to lead to premature failure of the devices, which necessitated the recall of the DePuy ASR implants, but, so far, has not resulted in the recall of a number of other metal-on-metal devices manufactured by DePuy (including some models in the popular Pinnacle family) as well as similar MOM products manufactured by Zimmer, Stryker, Biomet, Smith & Nephew, and other medical device companies.

• Pseudotumor from a Metal-on-Metal Hip, published in The Journal of Rheumatology, in 2011 – This publication from physicians in Tokyo includes a graphic, intra-operative photograph of a revision surgery where the synovial tissue has been stained due to the metallosis process.  This same staining as well as the presence of abnormal appearing inflammatory fluid and even metal shavings have been noted in other patients, including some of my clients, who have undergone revision surgeries following the DePuy ASR recall.  In the Japanese patient featured in this medical report, the surgeons noted the presence of pseudotumors in the patient’s pelvis, thigh, and gluteal region, which were triggered by a breakdown in the chemical properties of the metallic surfaces of the patient’s hip implant. This patient’s pseudotumors and obvious inflammatory reaction occurred about three years after being implanted with an Encore Medical metal-on-metal hip implant, a product that is now sold by DJO Surgical of Austin, Texas.

While the steady stream of new scientific reports are helpful to patients pursuing lawsuits against DePuy and other manufacturers, it is little comfort to those duped into implanting themselves with a toxic, defective product and are now faced with scary prospects with regard to their medical and surgical future.  While the Food & Drug Administration (“FDA”) has noted that it has been looking into safety issues for the past 15 months, the FDA’s slow pace in issuing stronger safety alerts and/or recalling defective metal-on-metal implants has resulted in tens of thousands of patients not being properly monitored for toxicity due to a lack of awareness by surgeons, patients, and the public.  I hope that the flood of new information will be disturbing enough for the FDA to act more definitively.

“Quid pro quo” happens in business all the time. You scratch my back, I’ll scratch yours.

Usually, the exchange is relatively even and the result doesn’t really cause any harm to anyone… or at least any harm of real consequence.

But, give me a million dollars for my “quo” and your “quid” must be huge!

That is what is happening between doctors and medical device manufacturers. Both drug companies and medical device manufacturers have been playing this game for decades. Whether it is a case in which the doctor gets paid for putting their name on an article they did not write and supporting the latest, greatest drug or they are paid for “consulting fees” that result in the doctor’s support of a particular new medical device. The result is the same – a respected name gets attached to the latest, greatest widget and sales rise.

The Chicago Tribune reports that “orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers…” Yes. You read that correctly – hundreds with six 0’s following them.

In 2007, device manufacturers were told they were going to be required to disclose payments made like this; so, since then the total amounts in tribute paid has dropped, while the amount of individual payments has gone up. So, manufacturers are simply being more selective in choosing “which” doctor and agreeable to paying a 40 % higher amount of “tribute” to each. The average payments per doctor have risen from $212,740 to $233,108; with some individual payments being as high as $1 million according to an analysis of statistics by Dr. Robert Steinbrook from Yale University School of Medicine.

Dr. Steinbrook notes that conflicts of interest continue as recently reported in The Spine Journal, in connection with a Medtronic clinical trial for recombinant bone morphogenetic protein:

“Financial information was available for 12 of the 13 original studies: “the median-known financial associations between the authors and Medtronic Inc were found to be approximately $12,000,000 to $16,000,000 per study (range, $560 000-$23 500 000). An editorial noted ‘a rising, if not malignant, doubt about the spine field’s ability to honestly assess and report on clinical practice and new technologies.”

Only 4% of physicians ever are treated with these bonuses by medical device manufacturers; so is it really a problem?

Yes.

The way your physician makes decisions about recommending drugs and medical devices is by reading about them in journals, going to conferences, and hearing about them from manufacturer sales representatives. The sales reps are a given that the information is slanted in favor of the manufacturer.

So, that leaves articles and conferences.

If the respected men and women in a given field are willing to receive payment for supporting a particular medical device or drug by making speeches at conferences or by talking to fellow physicians at them, then we are down to journal articles. We have already read the reports about articles being ghost written by marketing professionals and “experts” being paid to add their names as authors.

Who can your physician trust? Your physician who is simply trying to provide the best care he or she can – how do they make the best judgments of which device is the best and which new drug is the most effective? They read. They listen. The problem is…who are they listening to?

There are growing safety concerns over the anti-arrhythmia drug Multaq, (dronedarone), which is manufactured and marketed by Sanofi-Aventis and has generated a great deal of controversy and concern in just a few short years.

Multaq was first approved by the Food & Drug Administration (“FDA”) in 2009 for use as an anti-arrhythmic drug in heart patients with paroxysmal or persistent atrial fibrillation.  Atrial fibrillation is essentially an irregular heartbeat that may be a sign of an asymptomatic problem or may be a sign of a significant and life threatening problem. People with atrial fibrillation are exposed to things such as fainting, congestive heart failure, and stroke. Paroxymal refers to patients with symptoms that resolve in less than (7) days and persistent to patients with symptoms resolving in over (7) days.

The drug, Multaq, was prescribed in particular for patients with severe heart disease, including those who were elderly, had other serious medical conditions such as hypertension or diabetes, a history of a previous stroke or cerebrovascular accident, or had evidence of serious heart disease or heart failure based up on their EKG and echocardiogram findings. The drug carries a “black box warning” (the strongest level of warning on a prescription drug) informing physicians that Multaq should not be prescribed for patients with severe congestive heart failure because of  concerns that use of the drug might worsen patients’ heart failure symptoms or increase their chances of dying.

Here is just a glimpse into the questionable history of Multaq:

• July 1, 2009 – Multaq, (dronedarone hydrochloride), was approved by the FDA for sale in the United States.  The drug was subject to a Risk Evaluation and Mitigation Strategy (REMS), which essentially means that the drug had been identified as one that would require special care in its prescription and use. As such, it was accompanied by special patient materials and warning labels not distributed with other drugs that are evaluated as posing less risk to patients.
• Early 2010 – FDA warned of possible problems with congestive heart failure in patients taking Multaq.
• Spring 2010 – FDA warned of a possible link between Multaq and a potentially fatal ventricular arrhythmia known as torsades de pointes.  Other drugs, such as Propulsid, have been recalled due to links to this same life-threatening arrhythmia as well as an electrical conduction problem in the heart known as “long QT syndrome.”
• September 2010 – FDA includes Multaq in a report entitled “Potential Signals of Serious Risks/New Safety Information Indentified by Adverse Event Reporting System (AERS) between July – September 2010,” which was part of a new initiative by the FDA to alert the public and medical community about potential, emerging drug-related safety issues.  This same report included some other drugs that remain under a cloud of suspicion and/or are the subject of current litigation efforts, including Epogen and Procrit (possible contamination with lamellae); Gemzar (liver toxicity); Keppra (linked to Stevens Johnson Syndrome and Toxic Epidermal Necrolysis); and Actos (rhabdomyolysis).
• January 14, 2011 – The FDA issued a Drug Safety Communication directed to patients and healthcare professionals regarding its receipt of numerous adverse event reports (also known as AERs) relating to liver toxicity, serious liver injuries, and acute liver failure requiring a liver transplant in patients taking Multaq.  At that time, it was estimated that more than 147,000 patients had taken the drug in the 18 months since it was approved.

Often, the potential for a new drug to cause liver failure is not identified until the drug is given to a large number of patients after the drug is placed on the market, and these patients, sadly, unknowingly serve as real world guinea pigs for new drugs that are tested on too few and under aggressively-controlled study protocol, such that study participants are often pulled from the pre-marketing clinical studies at the first signs of any toxicity and before it is possible to detect potential liver problems.  Drug-induced liver problems are a serious health issue in the United States, with more than 400 prescription and over-the-counter drugs being linked to hepatoxicity, with only a fraction of these drugs being recalled due to liver-related safety issues.

• February 11, 2011 – Drug warning label enhanced to include the risks of acute liver failure or hepatic toxicity.  The symptoms associated with acute liver failure include jaundice, abdominal pain, dark urine, itching, fever, malaise, anorexia, vomiting, and nausea.  Patients may also have abnormal blood tests slowing elevated liver enzymes.
• March 11, 2011 – Drug warning label further changed to discuss the potential for drug interactions, especially with warfarin (also known as Coumadin).
• June 21, 2011 – Multaq’s warning label was changed yet again to note that some patients who had taken the drug had developed serious pulmonary and respiratory problems, including interstitial lung disease, pneumonitis, and pulmonary fibrosis.  These serious lung problems had not been noted in the limited clinical trials completed to evaluate the safety of Multaq prior to FDA approval.
• July 21, 2011 – The FDA issued a “Drug Safety Communication” to doctors and patients regarding the increased risk of death and serious cardiovascular adverse events noted in an ongoing clinical trial involving patients taking Multaq (or dronedarone) for permanent atrial fibrillation (an indication for use of the drug that had not yet been approved by the FDA).  This clinical study is known as the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) Study.  The July of 2011 safety alert indicated that from July of 2009 through June of 2011 approximately 241,000 patients had ingested Multaq.  At that time, patients were urged to consult with their physicians regarding whether they should discontinue the medication, and were encouraged to report adverse events to the FDA and Sanofi-Aventis.  Physicians were also urged not to prescribe Multaq to patients with permanent atrial fibrillation, an off-label use of the drug. At that time, the FDA indicated that the data showing potential safety issues in the PALLAS clinical trial was preliminary, and that the Agency would be conducting a more thorough review to determine whether the same increased risk of cardiovascular death or serious heart-related side effects noted in study patients with permanent atrial fibrillation might also be seen in patients taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter, conditions for which the drug had been approved by the FDA in 2009.
• August 5, 2011 – The Food & Drug Administrator and the manufacturer of Multaq updated the “Risk Evaluation and Mitigation Strategy (REMS)” plan, in order to further outline efforts to be undertaken to provide better information to patients and prescribing physicians in hopes of preventing future injuries and death to patients using Multaq.  In addition, patients who have suffered serious adverse reactions were urged to report them to the Food & Drug Administration at 1-800-FDA-1088 or at www.fda.gov/medwatch.  Patients have also been cautioned to consult with their physicians prior to discontinuing Multaq, as there are serious potential side effects if patients abruptly stop taking this medication.
• August 22, 2011 – The warning label was again modified to reflect that patients may experience changes in their kidney function while taking Multaq.  Adverse event reports have noted that patients experienced elevations in their creatinine and blood urea nitrogen (BUN) levels while taking Multaq.
• September 22, 2011 – The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), the drug safety organization similar to the FDA that oversees drug safety in the European Union, met to discuss safety concerns over Multaq and whether the drug should continue to be prescribed in Europe.

In the past, the EMA has shown that it is more inclined to move swiftly to recall dangerous drugs and to put the welfare of patients before the interests of the pharmaceutical industry, unlike the FDA which has shown a tendency to move at a much slower pace while it studies safety issues relating to drugs (and, sadly, to give the drug manufacturers a few more months or years for last-ditch efforts to peddle unsafe pills).  The EMA committee recommended that use of Multaq be limited in light of evidence that the drug was associated with serious adverse effects on the liver, heart, and lungs.

Meanwhile, patients in the United States are faced, yet again, with a difficult situation.  So, what should Multaq patients do?  Patients should consult with their physician now and on a regular basis to determine whether continued use of Multaq, in the face of growing safety concerns, is warranted given their particular medical history and personal risk factors.

Patients should also urge the drug manufacturers and the FDA to be more proactive in removing dangerous drugs from the market rather than continuing to issue press releases and revised warning labels which, obviously, are failing to protect patients from drug-induced injuries.

For additional resources related to Multaq, please visit these sites:

Manufacturer’s web site

Medication Guide for Patients

REMS

July 2009 label

February 2011 label

March 2011 label

June 2011 label

August 2011 label

FDA summary memo regarding review of the new drug application for Multaq

FDA drug approval package

7/21/2011 Safety Alert

1/14/2011 Safety Alert

January 2011 – FDA podcast on liver toxicity

Many physical, social, and chemical changes happen to a woman both before and after her pregnancy.  These changes can lead to women suffering from a number of symptoms including depression.  In fact, it has been said that one out of every five women has symptoms of depression during their pregnancy.

Naturally, women seek help to battle these illnesses and often resort to medicine to prevent adverse effects to themselves and their child.  However, using medications containing sertraline hydrochloride, such as Zoloft, to combat depression can lead to serious issues for a developing child.

Zoloft was approved by the FDA in 1991 and is currently manufactured by Pfizer, Inc.  Zoloft is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) and works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.  Zoloft has proven to be a large source of revenue for Pfizer and in 2010, brought in $532 million in revenue, a 3% increase in sales from 2009; nearly a billion dollars in sales in just two years.

Zoloft has been used to treat illnesses such as:

• depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over)
• panic attacks, (sudden, unexpected attacks of extreme fear and worry about these attacks)
• post-traumatic stress disorder (psychological symptoms that develop after a frightening experience)
• social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life)

Research has demonstrated that Zoloft can cause adverse effects in babies that include: heart problems, low birth weight, and high blood pressure in the arteries that supply blood to the lungs (pulmonary hypertension).  These side effects have been so serious that the FDA has released warnings of Zoloft’s danger like this one posted in July 2006:

“The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) was recently published in a medical journal. Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies.  Babies with PPHN can be very sick and may die.  The study results showed that babies born to mothers who took selective serotonin reuptake inhibitors (SSRIs), the family of medicines Zoloft® belongs to, 20 weeks or later in their pregnancies had a higher chance (were 6 times as likely) to have PPHN than babies born to mothers who did not take antidepressants during pregnancy (6-12 per 1000 births versus 1-2 per 1000 births). The FDA plans to further look at the role of SSRIs in babies with PPHN.”

Additionally, doctors such as Peter R. Breggin, MD, who published a study on the topic, concluded:

“Pregnant mothers should avoid taking SSRI antidepressants—they are hazardous to the developing fetus, cause withdrawal symptoms in the newborn baby, and induce biochemical and morphological abnormalities in the brain. If pregnant mothers need help with sad or anxious feelings, they should seek counseling or psychotherapy, especially family therapy involving the child’s father, as well as other sources of emotional support.”

As Dr. Breggin has recommended, depression can be treated in several ways. Support groups may help.  But most importantly, if you know a woman that is taking an antidepressant and wants to get pregnant, make sure that she talks to her health care provider beforehand. Together, they will decide whether she should keep taking the medication, change the medication, gradually reduce the dose, or stop taking it all together.

Wow, the federal regulatory agency, Federal trade Commission (FTC), has taken a firm stand on products that promise “a better way to a better butt”. The FTC has reached a settlement with shoemaker, Reebok, over its claims concerning the popular EasyTone shoes.

I must confess that until reading the article in The Washington Post, I had not heard of EasyTone shoes and the claims Reebok was making about them. Apparently both the claims and the advertising were something that hit home with consumers because Reebok reportedly sold over $500 million of them in 2010.

I wanted to do a little investigating since I had never seen any of the commercials for EasyTone or the shoes that make similar claims made by Skechers. Here is one of the commercials:

I can understand why the FTC would get so worked up about the claims if they are false. I mean assuming they do not do what they claim; we could have sagging all over America. What if you actually had to exercise? I mean its absolutely outrageous.

Okay, I agree that if any manufacturer makes a claim about a product and it is not true (although Reebok and Skecher claim theirs is true), they should have to pay a price for false advertising. In this case, the FTC settled with Reebok for $25 million; probably representing some fraction of their profit margin in a single year. That is significant and important – and, it is exactly what the Federal Trade Commission is in the business to do.

I guess my “tongue in cheek” reaction results from comparing the FTC nailing Reebok for sagging butts, while drug manufacturers play in advertising Shangri-La on a regular basis. Take a look at the Reebok ad again. See all the imagery and visual suggestion? Drug companies do exactly the same thing; except drug companies are selling drugs, not the newest “uplift” device.

Ask yourself, what does attractive, successful, professional women sitting in a very expensive bar, have to do with Yaz birth control medication? Or, what does Humira have to do with planting sun flowers? How does Vioxx really relate to walking down a beach to go fishing as the sun rises radiantly over the ocean?

Drug manufacturers spend billions every year trying to tell us about the latest disease and, oh yeah, sell us their latest cure for the latest disease. In 2005 alone drug companies spent over $58 billion for promotion of pharmaceutical drugs to consumers. Drugs consumers can not just go buy, but must get a prescription from their doctor in order to obtain them.

In 2005, drug companies only spent $32 billion on research. That is nearly 50% of what they spent on advertising and that is both a startling and telling statistic.

What are the priorities for Big Pharma? They need the latest, greatest disease so they can tell you about it, suggest you may have it and convince you that they have the answer for you. And, the pressure is on them, because they have to do all of this before the studies come out that tell us the latest cure is simply making people sicker, killing people or that it simply does not really work. The profit must be made before the truth is known.

Be sure that drug companies are in the profit business. Although I know there are plenty of well-intentioned scientists employed by Big Pharma companies who are interested in helping people, finding the great cure for the worst disease. But, at the end of the day, drug companies make decisions based from profit motives and their marketing departments drive decisions a whole lot more than their research and science departments.

So, I am happy that the FTC takes their job seriously and, if Reebok’s claims were untrue, I am happy that they were forced to pay some penalty.

But when will the Food & Drug Administration take some pages from the FTC’s playbook and start bringing down real regulation on drug company advertising to consumers. When will the FDA put a stop to advertising that dilutes drug complications, expands drug benefits and suggests to consumers that if they do not feel sick, maybe they should think about it a little more

I went back and took a look at many of the drug companies advertisements and I seem to have remembered seeing every one of them. The Reebok ad, though, is one I missed and, I am reasonably certain I would have remembered it.

Your blood needs to clot, but it is a delicate balance. Insufficient clotting leads to excessive bleeding and too much clotting leads to obstructed blood flow, pulmonary embolism and strokes.

So, it is understandable that the Food & Drug Administration became worried about reports that birth control medications containing drospirenone were causing excessive clotting in women taking them. The FDA decided to conduct a review of literature and investigate the potential risks associated with birth control drugs such as, Yasmin, Zarah, Syeda, Safyral, Ocella, Yaz, Loryna, Gianvi, and Beyaz.

The Food & Drug Administration has now reached some preliminary conclusions that would be disturbing to me if I were a woman taking these medications. The FDA believe s that the increased risk for blood clots, pulmonary embolism and stroke are around 1.5 times more in women taking the drugs than in women taking other types of similar medications for birth control.

The manufacturer of Yaz and Yasmin agreed with the FDA in 2010 to amend its labeling to alert users of the potential for venous thromboembolism (VTE), but also indicated the risk was no greater than with other oral contraceptive preparations.

There are really two central issues.

The study and investigation being conducted by the Food & Drug Administration is exactly the same evaluation which should have been conducted by the manufacturers of these drugs BEFORE they were placed on the market. Where were the manufacturers when these drugs were being evaluated through clinical testing? Were risks of VTE suppressed during clinical trials? Were all the data of clinical trials provided to the FDA at the time the drug was submitted for final approval?

When Bayer began producing its commercials for Yaz depicting young, successful, attractive women talking about the miracles of Yaz, did they know? When Bayer began pushing the envelope by trying to promote Yaz as a treatment for acne in young women, did they know about the increased risks of stroke? When Yaz commercials with their fun loving, balloon flying commercials tried to lure young women to Yaz, did Bayer know that each person faced a potential one and one half times greater risk they would develop a stroke or risk death as a result of a pulmonary embolus?

So, it is great that the FDA is now evaluating these dangers of medications like Yaz, Yasmin and Beyaz; but where were these investigations and studies when manufacturers were making billions of dollars through the sale of them to young women?

The evidence condemning Metal on Metal (MOM) implants continues to grow. In a recent announcement by the National Joint Registry for England and Wales (NJR), it was revealed that 30% of MOM implants manufactured by DePuy Orthopaedics, Inc., a division of Johnson & Johnson require removal and revision within six years of implantation. The industry standard is 15 years or more.

In its report, the NJR revealed that MOM hip devices experience “by far” the highest rate of revision including removal and replacement. NJR data indicates that these devices are failing at double or triple the rate of others at five years. In addition, the report indicates that as time passes, the failure rate increases when compared to other hip implants. The data also tell us that women fared worse than men.

This report follows DePuy and Johnson & Johnson’s recall of both its ASR XL Acetabular and ASR Hip Resurfacing systems in August of 2011. It appears the recall was warranted. At the time of the recall, the reported failure rate for these two systems was 13%. This new data suggests the failure rate was even higher at 17%. At six years the NJR reported that 29% or almost one third of these devices required revision. Even a lay person with no medical training should recognize that failure rate as staggering. It also calls into question how the company and regulators would fail to identify this problem before doctors started pounding these rods and cups into the hips of thousands of patients!

The sad truth is they didn’t. Even if the company did, it’s unclear what they would have done with the information. A DePuy “spokesperson” said in response to the reported 1/3 failure rate that it, “shouldn’t necessarily be taken as gospel.”

Unlike other consumer recalls, dealing with the problem is not as simple as taking your car into the dealership for repairs. These patients have the defective devices implanted in their bodies. Fixing the problem requires undergoing painful revision surgery. Doctors are on record saying that revision surgery is much more complicated than the original surgery and carries far more risks. Many are unsuccessful leaving the patient with permanent disabilities.

In addition to regulatory action in Europe, the FDA has ordered 21 manufacturers of MOM implants to carefully study the issue of whether patients with these implants are being poisoned by the release of metal shavings or debris that is cast off when the device fails. Studies of patients with MOM implants have reported abnormally high blood levels of Cobalt and Chromium which are potentially dangerous. The FDA is studying the long term effects of heavy metal poisoning in these patients.

If you are a user of bisphosphonate drugs – be a very active participant in your therapy; do periodic research; ask questions; and demand reasonable answers.

An advisory panel to the Food & Drug Administration has recently taken action on the danger presented by drugs such as: Actonel, Fosamax and Boniva. These are drugs originally marketed by Merck (Fosamax) and prescribed for people suffering from osteoporosis. Sadly, the decisive action the committee panelists decided to take was to affirmatively do nothing. So, unless the FDA itself acts to strengthen warnings or information provided to patients at the time these drugs are prescribed, it will require vigilance on the part of patients to protect themselves.

Osteoporosis is a thinning of bone tissue and a loss of density in bone that usually develops over time. It is the single most common form of bone disease known. Ironically, bisphosphonates have been found by a number of researchers to cause atypical thigh and jaw fractures in patients taking them. This is particularly remarkable after patients have been taking the drugs for around five years or more.

One of the members of the advisory panel, Lewis Nelson, director of medical toxicology at New York University, said, “…be very clear that efficacy may fall off after a period of time, perhaps five years. Serious concerns have been raised about risk, and those need to be continually evaluated as well.”

Bisphosphonate sales has been a huge money maker for pharmaceutical companies:

• Fosamax’s, Merck, reached sales as high as $3.19 billion in 2005 before other maker’s products sharply reduced those yearly sales.
• Actonel’s maker, Warner Chilcott had 2010 sales of $579 million.
• All together bisphosphonate sales generated $4.2 billion in the U.S. and $7.6 billion in sales worldwide during 2010.

Merck ten year clinical studies demonstrate that Fosamax’s benefits outweigh its potential hazards to osteoporosis patients – there is a big surprise.

In a 17 to 6 vote, some panelists felt new, stronger warnings should be provided to patients. Other panelists felt there was insufficient data to warrant stronger warnings than already exist.

Dr. Jennifer P Schneider has a little different view. She was taking bisphosphonate drugs for osteoporosis, but was otherwise a completely healthy woman, when her femur fractured as she was simply standing and waiting for a New York subway train. She sets forth:

What should we advise our patients?  Bisphosphonates are stored in bone for up to 10 years after their consumption is stopped, although their metabolic effects are of shorter duration.  Studies have shown the efficacy of bisphosphonates in the first five years of therapy in improving bone density and diminishing the risk of fractures. After that, until additional studies are done that clarify the risks of non-traumatic fractures and delayed healing in patients on long-term bisphosphonates, and which risk factors, if any, can help predict which patients are at increased risk of these adverse events, it is reasonable to suggest to patients to stop the drug after several years, continue weight-bearing exercise and calcium, and wait to see what the next scheduled DEXA scan shows.

Well I am neither a doctor nor a scientist; which may help explain why I am scratching my head in bewilderment after reading the latest article at msnbc.com.  The article sets forth an association between common household NSAID’S (non-steroidal anti-inflammatory drugs) with an elevated risk of miscarriages. You are familiar with the NSAID drugs, like Aleve and Ibuprofen that we are encouraged to use for headaches and other pain.

According to a study in the Canadian Medical Association Journal there is almost 2.5 times an increase in the risk of miscarriage while using these drugs. As the article states it’s no time to “freak out”, but it certainly seems like a time to take notice. The marketing machines behind some of these drugs portray that these over the counter medications are almost like taking a multivitamin. This study once again shows that things aren’t always as simple or benign as they are represented in drug company advertising.

Listen, if I do not take NSAID’s, obviously this one issue doesn’t directly affect my body, but I have a wife and 3 beautiful girls to worry about.

When I view this newest concern with recent Celebrex ads I’ve watched it has not left me with warm and fuzzy feelings for Big Pharma and their methods. When a product that was essentially pulled from the market place, like Celebrex, now in the “new roll out – take 2” mode,  comes out swinging with commercials that boast Celebrex essentially has the same exact cardiovascular risk factors as common household NSAIDS, I am left a little empty.  So over the counter NSAID’s are just as risky? Great, am I supposed to feel better about Celebrex or should I be a heck of a lot more concerned about existing over the counter NSAID products? For me, I continue to be confused….

I have also learned a lot more about NSAID’S and their role in causing Stevens-Johnson syndrome. According to Skin Association there are links to Stevens-Johnson syndrome, a potentially deadly skin disease that usually results from a drug reactions, and NSAID’S. Think of Stevens – Johnson syndrome as something that burns your skin from the inside out; ultimately resulting in 3^rd degree burns all over your body. It is painful and ultimately can be fatal – all the result of the way some drugs react.

I know, I know, it’s all very confusing. Should we trust these studies or “links” when they conflict with the ones that drug manufacturers set up?

Or even better, should it simply be a “buyer beware” in the arena of chemicals, compounds and drugs?

Should consumers be required to not only read the very tiny, tiny fine print on the drug labels, but also maintain sufficient chemical engineering acumen to truly understand them?

Plus, even if you read the scientific and legalese mumbo jumbo put out in the past there have been strong concerns that inadequate warnings have existed associating the NSAID’s with all of these issues. Considering these products are in the homes of almost every American, being used by the young, the old and yes, even those who are pregnant, should not more be done to properly warn the unsuspecting consumer?

Our modern times have created a hectic life and not everyone has the time to read complicated details in fine print stuffed in the bottom of discarded boxes. Not everyone reads scientific articles, which often require medical knowledge to understand them as a part for their work, as I do.

I think these various warnings should be delivered to all us consumers in a manner, at least equally effectively, if not more so than the slickly produced ads that run on TV and in print to sell drugs.

The last time I got an Advil coupon in my Sunday paper it wasn’t in tiny black and white print, folded up 15 times, and laying at the bottom of the newspaper sleeve to be easily discarded. It was in full color, large print and had pretty decorations – well, except the part about when it expired.

Since the 1980s, many have turned to medications such as Prozac to combat their depression.  However, those who are pregnant or attempting to get pregnant need to think again before taking these drugs.  In fact, Prozac, when taken during pregnancy, has resulted in many birth defects, some of which include limb defects, craniosynostosis, anal atresia, persistent pulmonary hypertension of the newborn (PPHN), omphalocele, heart defects, and neural tube birth defects.

On July 19, 2006, the FDA released a warning that SSRI antidepressants can cause serious or life-threatening lung problems in newborns whose mothers took the medication while pregnant. The warning came after a study was published in the New England Journal of Medicine that showed infants were six times more likely to suffer Persistent Pulmonary Hypertension in the Newborn (PPHN) after being exposed to SSRIs, the class of drugs that includes Prozac, Paxil, Celexa, Effexor, Lexapro, Pristiq, and Zoloft.   Babies whose mothers took Prozac and other antidepressant drugs in this class while pregnant may also suffer withdrawal symptoms such as agitation, poor feeding, and insomnia.

Prozac (also known as fluoxetine) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. Prozac affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.  In the early 1970s, evidence of the role of serotonin in depression began to emerge, and the hypothesis that enhancing 5-HT neurotransmission would be a helpful way to combat depression was put forward.  On the basis of this hypothesis, efforts to develop agents that inhibit the uptake of 5-HT were initiated. These studies led to the discovery and development of Prozac, which was approved for the treatment of depression by the FDA in 1987.

Prozac has been manufactured and marketed by Eli Lilly & Company, which is based in Indianapolis, Indiana.  However, on August 2, 2011, Lily’s patent for this profitable drug expired.  This has resulted in an estimated loss of  $2.4 billion in annual sales for Lilly.   The patent was invalidated after a lengthy legal battle waged by a small, aggressive generic-drug company called Barr Laboratories.  The loss of this patent lawsuit by Lilly will allow other companies that want to sell the drug to be able to do so.  Now, a 20-milligram capsule that presently retails for $2.50 likely will fall to less than 25 cents per capsule.  This will significantly affect Lilly’s revenues, which were reported during the 2010 fiscal year to be $23 billion in total sales and $5 billion in net income.  Since it was launched in early 1988, Prozac has been one of the biggest-selling drugs in history; its $21 billion in sales represents about 30% of Lilly’s revenues in that period.  Lilly is also the manufacturer of other well-known psychiatric drugs, including  Cymbalta and Zyprexa.

It is unclear at this time how this change in the patent protection for Prozac will affect some of the pending and upcoming litigation being filed on behalf of children who have suffered devastating birth defects as a result of their mother’s ingestion of this drug during the first trimester of their pregnancies.  Nonetheless, the drug is still being prescribed and children are still being born with birth defects.

It is important that patients obtain the facts about antidepressants and use of the drugs during pregnancy.  It is also important that patients understand what remains unknown about the potential safety risks that Prozac and other drugs pose to a developing fetus, facts that would be shocking to most patients especially since the drugs have been marketed for more than 20 years!  Most importantly, speak with your doctor before doing anything, especially before getting off the medication, as it is very important that patients be properly weaned from antidepressants and that other supportive therapy be administered to manage the depression.