How the Sunshine Act Will Save You Money

by Gary Pepper M.D. | Nov 30, 2014 | diabetes, health, health insurance, Medical Economics | 0 comments

By Gary Pepper, M.D.

Have you noticed that medication costs are skyrocketing? Even if you donâ€™t take medication these higher costs are passed along to you in your health insurance premiums. The recently enacted Sunshine Act will combat these economic forces but in ways you may not realize. The legislation requires pharmaceutical companies to report all payments made to doctors. Physicians receiving substantial amounts of money from these companies include “thought leaders” who are sponsored by the drug companies to lecture the nationâ€™s doctors on newly approved medications. Not surprisingly the driving force behind the pharmaceutical company activities is corporate profit not education. By controlling the educators, drug companies are able to influence the prescribing habits of the nationâ€™s doctors. In almost every case the medications being promoted are much more expensive than existing medications, and donâ€™t always provide additional benefit. A case in point involves new drugs used for diabetes treatment costing 100 times more than the established, generic medications,Â The Sunshine Act, by forcing disclosure of the financial relationship of the educator and the drug company, can help spotlight paid drug promotions masquerading as medical education.

The Sunshine Act is under attack by many in the medical field. The law is being called inaccurate, misleading and misguided. A full page editorial deploring the Sunshine Act as hurting medical education just appeared in the quarterly newsletter published by the primary organization of endocrinologists, the American Association of Clinical Endocrinologists. My thought is just the opposite. I believe the Sunshine Act will improve medical education which is now more and more dependent on money tied to drug promotion. When money received by individual doctor/teachers reaches the amounts revealed at the Sunshine Act website, the goal of the information being shared can no longer be trusted.

For those doubting this type of influence is already being wielded by the pharmaceutical industry, a prime example in the field of diabetes care is that of Dr. Talker (not his real name). After years of ground breaking research, the doctor now appears to be spending his time traveling the country paid by pharmaceutical companies to deliver promotional lectures. When Dr. Talker speaks the nation’s doctors listen. His latest focus is promoting the use of combinations of new drugs at an early stage of diabetes rather than following the standard approach of adding medications one at a time as the disease evolves. To maximize the impact of his comments, a front page banner headline was devoted to his lecture in Clinical Endocrinology News, a publication distributed free to doctors, supported by ads from the pharmaceutical industry. At this point the Sunshine Act illuminates a potential problem; specifically that Dr. Talker is highly compensated by the producer of two medications in the combination he advocates. The open payment section of theÂ Sunshine Act websiteÂ quickly reveals how much he received for his efforts. There are 15 pages of recorded payments to the doctor by drug manufacturers for the months August through December 2013 totaling approximately $112,000. Of these payments about $21,000 was from Astrazeneca, the company manufacturing 2 of the 3 drugs promoted by Dr. Talker.

Why should the public care about the influence the pharmaceutical companies wield over the nationâ€™s doctors? Using the example of the three drug diabetes treatment advocated by Dr. T, we can see what the economic impact is. Instead of starting treatment with generic drugs alone, which costs between zero (yes zero) to $41 dollars for a three month supply, Dr. Tâ€™s combination now should cost approximately $2200 for 3 months, based on existing prices of these medications. If the combination had been proven to be substantially better for treating diabetes than the generic alone, a patient might feel the price was worth it. However, there is no proven benefit of the combination over the generic alone. Furthermore, instead of being exposed to potential side effects of a single medication the patient will be exposed to three. Dr. T is lecturing from his individual viewpoint which happens to coincide with his sponsorâ€™s bottom line. The influence of higher costs for diabetes medications affects not just those paying for the drugs but everyone pays more reflected in the form of astronomical monthly medical insurance premiums and deductibles.

The Sunshine Act protects the nationâ€™s health care consumers. I urge you to join an internet campaign to support the continuation of this protection. Please leave a comment for Senator Bernie Sanders, head of the Senate subcommittee investigating the high price of prescription medications, with your own comment or the following words, â€œI support protecting patients from the consequences of pharmaceutical industry control of medical education. I support the Sunshine Act.â€ If Facebook is preferred, leave a comment on his page â€˜Senator Sandersâ€™ or you can contact the Senator on twitter, @SenSanders.

The opinions expressed here are solely those of the author who is not affiliated with any political party or pharmaceutical company.

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Welcome to the Thyroid Project

The mission of the The Thyroid Project is to encourage sharing of information and experience between the public and the medical community about the treatment of hypothyroidism (low thyroid function). For at least the past few decades there is a growing awareness of â€œsomething missingâ€ in the way suffers of hypothyroidism are treated for their disease.

Too many patients, as documented in an on-line study of 12,000 individuals conducted by the American Thyroid Association published in June 2018, (https://doi.org/10.1089/thy.2017.0681) , complain of persistent symptoms of hypothyroidism despite what their doctors believe is successful treatment with levothyroxine (brands include Synthroid, Unithroid, Tirosent, Levoxl). We believe something needs to be done to resolve this conflict between patients and their doctors.

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The Prediabetes Puzzle: What the Blood Tests Mean

Diabetes can be defined simply as elevated blood sugar levels. What exactly is high blood sugar and when should someone be concerned about their level? Does having prediabetes mean diabetes is around the corner? Metabolism.com tackles this tricky but important topic in this comprehensive review.

Unmasking the Dark Side of the Ozempic Craze

By Gary M. Pepper, M.D. Ozempic, Rybelsus, Trulicity, Wegovy, Saxenda are the central players in the weight loss craze sweeping across the globe. Metabolisim.com has been monitoring this phenomenon from its beginnings in 2008 with its report “Lizard Spit Reduces Blood Sugar and Appetite”, regarding the first drug in this class, Byetta (exenatide). Caught In the middle of the current chaos are the medical experts who treat diabetes and have been prescribing these medications for more than a decade. Here is a brief commentary from one such board certified endocrinologist; “I started treating Type 2 diabetics with GLP-1 agonists more than 10 years ago. In some respects, these medications have revolutionized the treatment of diabetes by lowering blood sugar effectively and promoting weight loss at the same time, a unique combination of benefits. Not everyone benefits from these drugs to the same degree unfortunately, and I have seen lots of patients experience unacceptable side effects from them. Nothing though, has prepared me for what is happening now. Too often, I find myself confronting someone who expects me to prescribe one of these drugs just so they can lose weight. Sadly, one extreme example was someone who, despite battling a life threatening medical condition, was insistent on getting a prescription. At the same time my diabetic patients are scrambling to find a place to buy their medications if they can even afford it. It is disheartening, to say the least, and I dread the negative interactions with some of my patients I now face almost daily.”

Off- Label Use

The FDA is the U.S. government’s department tasked with evaluating and approving drugs for specific medical conditions. When a new medication is approved for treating a medical condition by the FDA the agency will, at the same time, set strict guidelines for exactly which patients may use the newly approved drug. When a medication is used “off-label” it means that these limitations are being overridden by the provider for a potential benefit which outweighs the drugs risks. It is a general misconception that off-label means illegal; it does not. This practice has been going on for ages and more than 20% of prescriptions in the United States are prescribed off-label. A common example is the use of beta-blockers (approved for heart problems) for the treatment of performance anxiety.

GLP-1 agonist drugs, as discussed recently by metabolism.com. were originally approved for the treatment of Type 2 diabetes in adults. In the past few years most of these same medications have gained unprecedented popularity for their “off-label” weight loss benefit. Of the 5 GLP-1 agents presently in U.S. pharmacies only Wegovy (semaglutide) and Saxenda (liraglutide) are FDA approved for treating obesity. Of these two, Wegovy is the newer and had been much more popular that its sister drug Saxenda, probably due to being dosed only once weekly compared to daily for Saxenda and less likely to cause side effects. Due to Wegovy’s soaring popularity, its manufacturer, Novo Nordisk, increased the price of Wegovy two times since its initial release.

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Anti-obesity Medications 2023: The Controversy Continues

by Gary M. Pepper, M.D. and Sam Jeans, MSc The global anti-obesity drug market, in 2021was valued at over $2 billion. Within one year this figure had skyrocketed to $8 billion and is expected to climb to nearly $ 20 billion by 2027. This astounding growth is a reflection of soaring obesity rates, and the arrival of a new class of weight loss medication fueling a craze both in the USA and across the world.

The FDA and global health regulators, until very recently, had maintained a very tight ship when it comes to treating obesity with medication, placing the emphasis on diet and exercise rather than weight loss drugs. Since the 80s, anti-obesity drugs continued to be controversial, and a more stringent FDA implemented ongoing safety trials along with other precautions. There is some speculation that a shift in attitude toward approval of weight loss medication by the FDA , is underway

Weight loss drug controversies are far from over and, in fact, may soon rival the amphetamine crisis of the 70’s. For that reason, metabolism.com has felt it important to provide our guide to weight loss drug issues, past and present.

Anti-Obesity Drugs Timeline

Prescription drugs for lifestyle diseases such as obesity were marketed heavily throughout the 1950s to the 1970s. Amphetamines entered the public domain after the Second World War where they were used extensively in the military.

In the 50s, walk-in clinics prescribed diet pills with other medications almost at random, with or without genuine concern for one’s weight. These brightly colored pills became known as “rainbow pills”.

In the 1960s and 1970s, the so-called “rainbow pill diet” of pills was finally coming to an end as the FDA began to systematically ban many of the drugs involved. A high-profile expose by investigative journalist Susanna Mcbee, published in Life magazine, brought attention to this new modern public health crisis.

The rainbow pill diet combined amphetamines, laxatives, thyroid hormones, and even diuretics to produce extreme weight loss, combined with benzodiazepines, barbiturates, and steroids to reduce side effects, and antidepressants to suppress medication-induced insomnia and anxiety.

In 1968, rainbow pills were linked to over 60 deaths, with numerous accounts of their devastating impact surfacing in the news and media. Within just two months, 48 million pills were seized and destroyed. Nevertheless, amphetamine-based diet pills remained extremely popular throughout the 1970s. In 1978, some 3.3 million prescriptions for amphetamines were written each year, with some 50 million pills a year ending up in the black market.

In 1979, the FDA banned amphetamines as a weight loss aid, but that is hardly the end of the USA’s love affair with obesity medication.

Here’s a brief timeline of recent anti-obesity drugs: