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Eight years after approving its use, the FDA finds Lorcaserin (Belviq) is linked to cancer.

We encourage collaboratively sharing in medical decisions with your doctor based on a rigorous review of the benefits, risks, alternatives, and unknowns of all diagnostic or treatment plans.

The recent FDA announcement that a strong clinical trial it had ordered as a condition of its approval of Belviq for weight loss revealed an increase in cancer risk highlights the reasons for our collaborative philosophy of medical care. The FDA had ordered the trial to measure to any possible cardiovascular toxicity because it had found such toxicity after it approved prior weight loss drugs. Instead, it found an unexpected cancer risk.

While the risks of obesity are high, and the benefits of weight loss for that condition are also high, and the alternatives to medications like Belviq are also risky, finding a potential cancer risk reveals why using a treatment with so many unknowns should be approached with great caution, even after a long period of experience with the treatment by many doctors. You should have a say in deciding how such risks fit into your own goals and values.

It also reveals why even drugs considered to be “safe” based on their long term use warrant careful consideration each time they are prescribed. How long would it have taken for the cancer risk signal to have been discovered for Lorcaserin had the FDA not ordered a rigorous trial for a toxicity completely unrelated to the one it discovered? Few approved drugs receive such an order for more rapid rigorous analysis.

Take charge of your medical care by collaborating with your doctor. We can help educate, coach, and advocate to help. Call us at 203-692-4422, or email us at ajc@operamhealthcare.com for an introductory consultation.

Influenza vaccine is a critical decision in the COVID-19 era.

We most certainly agree that as with any medical decision, the decision to get vaccinated against influenza must be made in the context of a full understanding and evaluation of the benefits, risks, alternatives, and unknowns.

This year, that analysis is even more fraught with importance. Please carefully consider getting vaccinated early against influenza.

This year, Operam Healthcare is offering free consultation to those who wish assistance in making their decision regarding influenza vaccine. If you would like such coaching, please email or call, or check out our website for further information.

New developments in the Hydroxychloroquine controversy further reveal why you should fully share in your medical decisions

The COVID 19 pandemic has put enormous pressure on the medical and scientific communities to find answers quickly. The behavior of doctors and scientists under stress reveals cracks that have always been present, but have now become gaping fissures.

We recently reviewed the way hydroxychloroquine illustrates Sir William Osler’s famous observation that “medicine is a science of uncertainty and an art of probability.” The recent retractions of two large observational studies by two widely-respected medical journals highlight the powerful wisdom of Osler’s missive.

Many physicians rely on the information they read in those medical journals. However, many don’t take the time to dissect every study. They rely on experts to do it, and follow guidelines created by those experts to help them make their medical decisions.

The hydroxychloroquine dust-up reveals how even experts may miss critical flaws in research methods. That’s why it’s so critical that you collaborate well with your doctors. You should ask the hard questions they may not have.

Careful review of the benefits, risks, alternatives and unknowns is the powerful tool to fully explore the science behind difficult decisions. Knowing how to ask hard questions about what the experts say will help assure that any medical decision will account for the uncertainty, and apply the probability in a way that respects your own goals and values.

We can help to educate, coach and advocate to help you better collaborate with your doctors. If you would like to learn more, call 203-692-4422, or email ajc@operamhealthcare.com.

Hydroxychloroquine and Coronavirus: goals and values rise to the top for shared decisions-making

Our health and healthcare have fallen off a cliff, it seems. The current global pandemic highlights the importance of sustaining good relationships in our healthcare system and in our daily lives.

This pandemic will forever change the way we relate to our doctors, and the way health care gets delivered to us. Our social network has crossed a tipping point; just as water seems perfectly serene until the moment it begins to change into steam, new processes will now rapidly and relentlessly emerge in the American health care system.

In the midst of this crisis we have learned the value of good relationships between doctors and their patients. It is much easier to share in uncertain decisions about treatments with unclear evidence when we trust the way our doctors share our medical decisions with us.

If we follow the simple rule of fully examining the benefits, risks, alternatives and unknowns of any medical decision, and fully understating our own goals and values, we can come to a decision that makes sense even in the midst of its stark uncertainty and powerful exigency.

For now, hydroxychloroquine and azithromycin seem to be the simplest and safest alternative for preventing the novel coronavirus from becoming a devastating infection. But even if that turns out to be true, it doesn’t mean it’s the right treatment for everyone. It will take a long time to learn whether or not its safety and efficacy outweigh its risk in widespread use for this disease with such diverse manifestations – from asymptomatic to overwhelmingly lethal. Although one of the most widely used medications in the world as treatment for malaria, rheumatoid arthritis and systemic lupus erythematosis treatment, hydtoxyurea’s use in those settings is so radically different than its use for COVID 19 that we cannot easily use its long safety record to guide its wider application.

Currently, the decision to use it can only be guided by individual goals and values. We must each decide how comfortable we are with unknown risks and unclear benefits when our lives are on the line. We’ve witnessed decisions go both ways. We simply encourage our readers and members to fully explore theirs, and we hope for the best outcomes for all.

If you would like to explore more about how to make good shared decisions with your doctors, or to learn more about the details of various treatments for COVID 19, email ajc@operamhealthcare.com or call 203-692-4422 for a consultation.

Another FDA approved drug is recalled. “Approved” does not mean fully tested.

The weight loss drug Belvique has been withdrawn from the market by its producer, Esai Pharmaceuticals After post-marketing studies revealed an increased risk of cancer.

The FDA approved the drug for routine prescription, but only if the maker conducted “post-marketing” study of a potential cancer risk identified in preliminary research. That five year follow up study revealed an increased risk of cancer among those taking the approved drug. This is another example of why “approved” does not mean fully tested.

All medical decisions should be made with your full collaboration and understanding of the benefits, risks, alternatives, and unknowns of the treatment being prescribed.

If you would like to learn more about how we can help educate you about medical facts, or coach you to collaborate better with your doctor regarding your medical decisions, email us or call 203-692-4422 for a free introductory consultation.

When the prescribed cure is the actually the cause of an epidemic, the real cure is collaborative critical analysis.

Imagine going to your doctor with a problem, and getting a prescription that not only worsened it, but has a one in ten chance of actually killing you instead.  
The dramatic cognitive error that led medical experts to overlook an accepted medication as the cause of a serious epidemic is not rare. This essay from Massive Science  details how this kind of medical error has happened more than a few times in modern medical history.  We’ve witnessed many of those kinds of episodes over our 42 years in the healthcare field.
The cognitive bias built into the medical paradigm of treating diseases with poisons or clever devices designed to control biological functions (all medications poison some part of the biological system) often leads doctors to fail to distinguish the cure from the disease.  
Only robust doctor-patient collaboration to relentlessly analyze the benefits, risks, alternatives and unknowns of medical decisions can mitigate this powerful limitation of medical science and culture.
The essay vividly illustrates 2 critical problems that impede such shared health care decisions.  
First, the frequency of unknown effects of many treatments after they are approved for use but not adequately tested for all adverse effects.  
Second, the cultural blindness many experts and doctors have to those unknown possibilities.
The essay reviews some deadly illnesses that were attributed to diseases rather than to the side effects of their treatment that were causing those illnesses.  It reveals the cognitive biases built into the medical paradigm of treating diseases with approved medications but not considering the unknown possibilities of the adverse effects of the treatment on the patient.
It also reveals how difficult it is for even the best doctors to avoid that trap.  We at Operam have witnessed the effect over our long careers in healthcare, and we are dedicated to helping you ask your doctors the kinds of questions that can help them avoid the trap as they make medical decisions with you for your care.  
If you would like to learn more about how we can educate and coach you to better collaborate with your doctors, call us at 203-662-4422, or email ajc@operamhealthcare.com for a free introductory consultation