pharma

Will the Sunshine Act Curb Pharma Payments to Doctors?

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Just two weeks ago, as part of the Affordable Care Act, the Centers for Medicare and Medicade Services published its final rule on the reporting mandates for physician payments from pharmaceutical and medical device makers. Called the Physician Payment Sunshine Act, this law requires:

applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (“covered recipients”).

Why Is This Important?

For too many physicians, the medications they choose to prescribe are influenced by these payments. A case control study at a university hospital found that physicians who requested a new drug be added to the formalary were 19X more likely to have received money or gifts from the drug company. According to the New England Journal of Medicine as of 2007 fully 94% of all physicians accepted gifts from pharma, although by 2009, only 84% of physicians accepted gifts from pharma.

In their Dollars for Docs series, Propublica not only detailed the trail of money from the pharmaceutical industry to physicians and the changes in prescribing practices that ensued, but also, found that over 250 of the physicians receiving these payments had been disciplined by their state’s medical boards with the public never the wiser.

Wouldn’t you want to know if your physician was receiving payments to ‘consult’ on a particular drug or medical device? What if that drug or device turned out to be dangerous like, Avandia or Vioxx or in the case of women’s health Yasmin, Yaz or Ocella or even the vaginal mesh implants?  I would. And soon, you will be able to find this information, at least for those physicians that accept medicare or medicade. For the remaining physicians, we’ll have to rely on the stellar, investigative reporting of organizations like Propublica.

What Is the Physician Payment Sunshine Act?

The Physician Payment Sunshine Act mandates payments or ‘transfer of value’ to physicians be reported to the Secretary of Health and Human Services. Collection of this information is set to begin in August with full compliance and reporting expected in 2014.

The cool thing about this act, if it is implemented correctly, is that payment or transfer of value includes money for marketing activities, such as promotional or conference talks and consultation services. It also will include research grants and “charitable” contributions (which usually come with some promotional strings attached), funding to attend conferences, honoraria and royalties and license fees. The pharmaceutical and device companies making these payments will be required to list names, address, amount of payment, date of payment(s) and describe the service for the payment made for anything over $10. The database will be searchable so that patients can determine what monies their physicians received from pharma or device companies.

Where the Sunshine Act Fails

From the original to the final regulations, a work-around for paying physicians to speak at pharma sponsored continuing medical education (CME) events was added. According to the regulations, so long as the sponsoring company doesn’t pay the physician/speaker directly, those fees are acceptable and need not be listed publicly. Instead, the pharma company must pay a third party vendor to arrange and pay the speakers. CME conferences are where most physicians learn the latest drug therapy, device or medical technique. It is unlikely that speakers at these conferences will speak against the sponsor’s product. Funneling the payments through a third party vendor, who is also paid by the sponsor, is no more than a quick pass at laundering the fees.

What Do Physicians Think About the Sunshine Act?

The opinions are mixed, at least publicly. Some physicians are fully behind the new efforts in transparency and have begun their own campaigns to disentangle the marketing relationships between pharma and physicians. The National Physicians Alliance sponsors the Unbranded Doctor campaign:

The National Physicians Alliance’s Unbranded Doctor is unmasking the pharmaceutical industry’s bogus claim that its marketing efforts are just educational ventures for physicians. By signing up physicians to renounce gifts, lecture fees, and “education” from companies, the Alliance is championing objectivity, integrity, and professionalism.

—Jerome Kassirer, MD
former Editor-in-Chief, New England Journal of Medicine

Similarly, the British Medical Journal (BMJ) has positioned itself as a lead proponent of transparency and open data. On the other hand, CME released a survey of over 500 physicians asking if the new regulations to list publicly whether industry sponsored their attendance at CMEs would curtail their attendance. The result was a resounding – yes.

  • 75% of physicians said the disclosure rules would affect their decision to attend at least somewhat.
  • 47%  of physicians said the disclosure rules would affect their decision to attend to a great extent.
  • 46% of CME speakers said the disclosure rule would affect their decision to participate as a panelist or presenter to a great extent
  • 25% percent said it would somewhat affect their participation

Will the Sunshine Act Curb Pharma Payments to Doctors?

Probably not. Unless and until full transparency about medical research, clinical trials and adverse events are made open and accessible to patients and physicians, medical marketing, fabricated data or omitted data, publication bias, and conflicts of interest will continue to pervade our healthcare system. Dangerous medications like the Yasmin suite of birth control pills and unsafe medical devices like J&J’s Gynecare Prolift will remain on the marketplace long after any reasonable person could vouch for their safety.

The Sunshine Act will, however, give patients one more tool to evaluate their physicians and give researchers, investigators and others a way to identify and publicize bad behavior. Who knows, maybe it will even save some money.

To find out if your physician receives money from the pharmaceutical industry go to Dollars for Docs.

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Photo by kike vega on Unsplash.

Photo by Hush Naidoo Jade Photography on Unsplash.

 

 

Health at the Nexus of Economics and Innovation

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Health innovation exists largely because of the promise of great profits. Whether it is new drugs, devices or even health insurance, the development of these products are firmly established capitalist endeavors. Health itself, however, like life, liberty or even the pursuit happiness exists on a different plane entirely, more closely aligning with the right of life than with a corollary product or commodity. Where it gets squishy is in determining who is responsible for paying for that right, especially when someone chooses to ignore the responsibility of good health, is genetically burdened with ill-health, faces poverty, or as is the case in modern industrial society, is sold ill-health by companies whose very existence depends upon products that cause illness.

Where do one’s right of life and presumably some quality of life or health end and the right to profits begin? Who shall pay for these rights? And are there innovation opportunities in defining or re-defining health as a right versus a product or a commodity?

Understanding Moral Hazard and Modern Health Care

In 2009, with the financial system in ruins, the phrase moral hazard burst into the daily lexicon. One could not listen to a news report without hearing how those responsible for the crisis pushed all of the risks of their highly profitable ventures on to everyone else – textbook moral hazard. And then, to make matters worse, we were being asked to bail out these giant institutions that crumbled our economy, while they continued to reap huge salaries and bonuses. The gall…

Many view health insurance and by association, healthcare, as an industry based upon moral hazard. Unlike the moral hazard of the current financial markets, however, where the chosen few distribute risk downward to the many, the moral hazard in health care presumes that the many distribute the risk back up to the few, those presumably responsible individuals, who are healthy. Indeed, the distribution of risk penalizes good health with the increased cost of bad health borne by all. “How dare we be asked to pay for our neighbor’s smoking or obesity?” The gall…

What is often missed in our moral outrage, is how being sick reduces the profitability for those at the top of the insurance industry. This is the crux of modern health care’s fatal flaw – a skewed version of moral hazard where health care is a commodity that few at the top of the food chain are willing to risk on those at the bottom.

Health Economics

Modern theories of health economics argue that the act of providing health care services to all and the distribution of those costs amongst everyone will reduce the total financial risks but also increase the need for care, and therefore reduce profits. The presumption is that when people are given low-cost health care will, they will choose to partake in more health care services in much the same way that lower prices encourage other product purchases.

Appendectomy anyone?

Despite the almost comical notion that people enjoy going to the doctor’s office and/or to the hospital in the same way they enjoy purchasing a new handbag, or that these services are like any other commodity driven purely by access and cost, this concept of moral hazard pervades the health care/insurance debate, with nary a question of its legitimacy or utility. What is more, this model likely reduces overall profitability of the industries that seek to reap the rewards from health while increasing the profits of those who benefit from illness or at least benefit from ignoring the illnesses their products cause.

Health Innovation

If health innovation (the products within the health care system, new drugs, devices, programs, vitamins etc.) are only developed on the promise of great profits, how does that square with the notion that individuals really don’t want to go to the doctors unless they have to? How do we reconcile the need for health innovation to maintain our economic and health vitality and the premise that health care isn’t a product in the traditional sense; that it isn’t needed or wanted until it is needed?

Marketing Health (or Illness)

The current healthcare business model answers that question with marketing. Make the consumer or the physician want or believe they need the products being sold. The pharmaceutical industry is quite successful marketing must-have medications and products and they do so by employing the same tactics and strategies used to market any other consumer product.

Indeed, the newer model products/drugs are akin to the designer versions of a handbag and yield the same ‘must-have’ response from the consumer (even the physician) who is willing to pay premium prices for the latest and greatest medication. Like the must-have handbags, newer drugs often have no more efficacy than older ones (sometimes are worse), often contain only single isomer changes  (meaning molecularly they are almost entirely the same drug as the earlier, cheaper version e.g. Lexapro and Celexa) and more often rest the perceived utility solely on re-branding. A brilliant model if it wasn’t health or life and death that was for sale.

Another Way

What would happen if health was re-conceptualized as a right? If it were considered a right, then there would be a duty to protect it, legally. The current practice approving drugs and devices would look very different than it is today. From a market standpoint, the backlash from those who profit from illness would be swift and intense, but the potential for innovation and profits from other sectors could be equally strong, if the opportunity is recognized.

As it stands, we have big pharma, big agriculture (pesticide and herbicide use), big coal, big tobacco and other industries profiting wildly from their products, while distributing the health and economic risks downward to the masses in the classic model of moral hazard. These industries bear little to no responsibility for the true health costs of their products. Those risks are dispersed over time and over millions of people.

On the other side, we have the health care industry, straddled with the burden of caring for an ever less healthy populous while simultaneously having to answer to shareholders demand for profits. Their model of moral hazard proscribes increased profits for the top, increased cost for the healthy, and reduced services for everyone else. The health care industry pushes back on the individual, dis-enrolling, reducing access, but pays little attention to the purveyors of bad health. They buy hook-line-and-sinker the notion that the individual is solely responsible for his/her health. And while that is true in many cases, in today’s cesspool of environmental carcinogens, dangerous and eventually recalled (although not before the damage is done), pharmaceuticals and devices, endocrine disruptors, and generally unhealthy food supply, no individual alone can avoid all contact with the garbage that is in our environment and ultimately causes illness. And they shouldn’t have to. If the industries that currently lose money from illness (insurance, hospitals, employers), would step in and push back against those that profit from illness, we would see a radical change in disease rates, an enormous reduction in health care costs and an incredible increase in innovation.

If health were a right akin to the right of life, then products that affect health would be judged not just on the perceived profit margin, but on the actual cost/benefit ratio to health. The economics of health would switch from how do we distribute the cost of ill-health among the masses to how do we reduce ill-health of the masses. If a product causes more ill health and costs more than it benefits, perhaps it shouldn’t be on the market. Right now the debate is over how not to break the bank by including sick people on the insurance rolls or providing access to care for the poor, perhaps the math would work better if we looked how to prevent illness in the first place.

Women’s Hormones: An Intellectual and Ethical Cul de Sac

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Menopause is barreling down with a ferocity that is difficult to ignore. Like many women my age, I’ve had my share of health challenges and, until recently, blindly trusted the pharmaceutical industry to fix all that ailed me. Health by chemistry was a great thing; oral contraceptives, a fabulous invention, allergy meds – ditto, pain killers – wonderful, and on, and on. Take a pill and feel better, isn’t that what we all want? But I, like so many women, have lost faith in pharmaceuticals. It’s not because the science isn’t cool, it is, in every area of pharmacology, except women’s hormone therapies. Here, intellectual curiosity and innovation have been replaced by status quo. Little has changed in this area of hormones and health in 60 years.

Hormones, Hormones, Everywhere and No Innovation in Sight

Since their inception, hormone replacement therapies (HRT) and oral contraceptives have dominated women’s health, immediately moving from seemingly narrow applications when first introduced to the almost mythical status as cure-alls for any female and many general health ailments. The history of both these pills is strikingly inglorious and utterly dumbfounding. Just on general principle, why would anyone believe any medication could be so widely beneficial for so many apparently disparate conditions? It is physiologically impossible.

For HRT especially, if one believes the marketing, the pills provide a veritable fountain of youth. Where is the science? But believe we did, and generations of women may now be paying the consequences.

From the very first estrogens synthesized and marketed to women everywhere (diethylstilbestrol- DES), through today’s HRTs and OCs, profit appears to override health concerns. Even in the 1930’s and 1940s before these drugs came to market, the carcinogenic risks were well known, and yet, they garnered FDA approval and were sold to millions, upon millions of women.

Synthetic Hormones

I have personal experience only with the often ignored side effects of oral contraceptives, as I have yet to reach the age of menopause. In my 20s, while on the presumable high estrogen dose of oral contraceptives that were common then, I had intense bouts of vertigo that would develop even when lying down and ever increasing blood pressure. After years of expensive testing could find no neurological cause for the vertigo and after repeated prescriptions to lower my blood pressure, I stopped taking the pill. I had enough. The vertigo stopped fairly soon thereafter and the blood pressure returned to normal. Over those several years, there was not a single physician that suggested I stop taking the pill, indeed I was prescribed more and more meds to counter the apparently unknown side effects of oral contraceptives and it was recommended I see a shrink because the vertigo had to be psychosomatic.

I look back at that time and I wonder how many other women suffered similar circumstances. What is this propensity to prescribe and continue prescribing medications in the face of apparent ill effects? Why are we ignoring, even at the patient level, the possibility that some meds may not work for some women (or men). The statistics bear this out, but there seems to be a natural inclination to minimize these risks. This is compounded of course, by intense marketing.

As I approach this menopausal stage, I again will be faced with yet another hormone-issue for which the choices are bad and worse. We know from the Women’s Health Initiative (WHI) in 2002, that HRT is not the panacea it was marketed to be and the risks associated with this medication are not benign.

Over a one year period, for every 10,000 women taking and estrogen plus progestin, the risk of developing these conditions increases by:

• Heart disease: 7 additional cases
• Breast cancer: 8 additional cases
• Stroke: 8 additional cases
• Blood clots: 18 additional cases

For estrogen only:

• Stroke: 12 additional cases
• Blood Clots: 6 additional cases

Consider however, the millions of women who will take or have taken HRT for years. As of 2010, over eight million women in the US alone take HRT, and will likely do so for at least a couple years. In this light, the increased risk of disease looks a lot scarier.

• Heart disease: 5600 new cases per year; 28,000 in five years
• Breast cancer: 6,400 new cases per year; 32,000 in five years
• Stroke: 6,400 new cases per year; 32,000 in five years
• Blood clots: 14,400 new cases per year; 72,000 in five years

When the WHI was published, some 17 million women in the US had been taking HRT for many, many years, even decades. That’s 13,600 new cases of breast cancer per year, 68,000 in five years! Despite these data, and the thousands of lawsuits that followed, HRT is still one of the most frequently prescribed medications worldwide. I think we can do better.

Statistics from the Mayo Clinic

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