When I was a member of the Massachusetts Public Health Council, a policy-setting division of the Department of Public Health, I had to recuse myself every time we voted on a proposal in which I had a personal financial stake. In fact, I often couldn’t participate in the discussion or make a decision whenever there was an appearance of a conflict of interest, even when there really wasn’t a conflict at all. Massachusetts took this matter very seriously and had a number of lawyers scrutinize every council member and every vote to make sure we were scrupulously following the roles. So it came as quite a shock when I learned that roughly 30% of US senators and 20% of House members hold assets in biomedical and health care companies but are perfectly free to introduce, discuss, and vote on legislation that significantly impacts those companies.

According to a report by STAT, a new non-profit organization devoted to investigative journalism in the health care industry, our Congressional representatives are substantial investors in Pfizer, Johnson &Johnson, and Merck, along with assorted other companies. Their investments exceeded $68 million in 2014. The people who have the biggest stake often use their influence in Congress to promote legislation that just happens to coincide with their personal interest. Republican representative Chris Collins, for example, has co-sponsored a bill that would repeal the recently instituted tax on medical devices (which is one of the ways the Affordable Care Act pays for health insurance for the previously uninsured) and he just happens to be invested in the medical device industry, which vociferously opposes the tax. He also has supported abandoning FDA surveillance of products after they are on the market and just happens to be the single largest stockholder in a biotech company. This in the face of the recommendations of an independent Institute of Medicine report that the absence of any meaningful post-market surveillance is one of the weakest links in the FDA and has been responsible for delays in discovering drug toxicity that have led to numerous deaths.

It’s not just Republicans who influence health care policy despite their clear and unequivocal personal financial stake. Democrat Scott Peters has spearheaded an effort to essentially allow drug companies to prolong their already lengthy patent protection of drugs, the principal bulwark against price competition in the pharmaceutical industry. His wife is a major investor in the industry, buying over half a million dollars worth of stock in 2015 alone.

Even when they have what appears to be a conflict of interest, our congressional representatives sometimes vote against their own interests. STAT cites the case of Senator David Ritter who introduced a bill that would allow US consumers to buy medications from Canada, something that the pharmaceutical industry opposes. He has a modest personal investment (in the neighborhood of $100,000) in health care stocks. But by and large, those with the greatest influence in Congress also have the largest stakes. Collins, for instance, is a member of the House Energy and Commerce Committee—which is charged with overseeing the FDA.

Why is this a geriatric issue? Older  people are disproportionately large users of medications and devices. By way of example, more than 60% of all total knee replacements are inserted in people over age 65. The mean for pacemaker insertion is 75.5 and the mean age for ICD (implantable cardiac defibrillator) is 66.2. In the drug arena, data from 2010 showed that seniors account for 13% of the population but consumer 34% of all prescription drugs. So while conflict of interest in Washington affects us all, it affects older people most dramatically. And older people vote—they can vote out those who support their personal interests and not those of their constituents.

We've known about the perils of conflict of interest among legislators for some time, just as we've known about potential conflict of interest among physicians who prescribe drugs and devices for their patients. The widely accepted solution to the problem is disclosure. And in fact it is the federal disclosure requirement that generated the thousands of pages of congressional disclosure forms which STAT used to generate its report. Maybe this is just the first step: maybe disclosure, when analyzed the way STAT has done, will lead to shaming and behavioral change. More likely, it won’t lead to any meaningful change. Disclosure isn’t enough. Transparency isn’t enough. We need to change the rules of the game.                                                                                              

In his 2005 book, On the Take, former New England Journal of Medicine editor Jerome Kassirer inveighed against the influence that drug and device companies exerted over physicians. Through a variety of strategies, ranging from subsidizing elaborate meals at medical conferences to lucrative consulting arrangements to all-expenses-paid travel to exotic resorts in exchange for product endorsement, corporate America affected and sometimes determined physician behavior. In response, many academic medical centers have banned pharmaceutical sales reps, the “detail men” of yesteryear and put sometimes stringent conflict of interest policies into effect. The Sunshine provision of the Affordable Care Act requires drug companies and device manufacturers to reveal how much money they gave to doctors and to hospitals and to whom they gave it. As of September, 2014 this information is publicly available on a special website maintained by the Centers for Medicare and Medicaid Services. Is this provision having an effect? Will it?

An article written by a health economist and a health lawyer predicted the law would be unlikely to have a direct effect on either patients (by dissuading them from seeing particular physicians) or on physicians (by shaming them into severing their relationship with drug or device manufacturers). It suggested there might nonetheless be a beneficial effect if what the authors called “learned intermediaries,” such as health insurance companies, begin discriminating against people or institutions that are the recipients of what they regard as excessive largesse.

Six states had already introduced legislation requiring disclosure of payments in the form of gifts, food, travel and fees long before the Sunshine Act was passed, and the results in those states give us a preview of what is to come. One study of the Massachusetts law, which went into effect in 2009, concluded that the disclosure requirements were associated with a fall in the total volume of prescriptions, a decrease in the use of brand name drugs, and a rise in the use of generic drugs. But it’s hard to tease out how much of the change was due to the law and how much due to other simultaneous changes in the culture of medicine.

It’s too soon to draw conclusions about the federal law, but some preliminary observations are raising red flags. According to an investigative journalism piece just published in the New York Times, the information available on OpenPayments, the CMS database, is incomplete and replete with errors. Some companies, whether intentionally or accidentally, misspell the names of their drugs and devices or use different names for the same drug in different sections of the database. All told, 40% of the records in the database are missing the names of the doctor or the hospital that received the payment. And indeed, when I checked this out by looking up a local academic hospital, I found that if I entered "Beth Israel Deaconess Hospital," the report said there were no conflicts entered for this facility, but when I entered "Beth Israel Deaconess Medical Center," I found dozens of them.

Even if the reporting were accurate, the real question is whether transparency alone will have a significant effect. I’m doubtful. For some time, medical journals have had disclosure requirements for articles. The result is that the reader knows about consulting relationships, advisory board memberships, and other financial ties authors have with their sponsors. Perhaps the reader will take more seriously those papers in which the authors have no disclosures to make than those where they have a litany of them. But in either case, the article has passed muster: it has made it past the gauntlet of peer review, it has the journal’s stamp of approval. Does anyone seriously discredit a paper because of the author’s pedigree?

Does any of this matter? In particular, what does it have to do with medical care for older people? A great deal. Older patients comprise a huge part of the market for most drugs and most devices.  The average 65-year-old takes 4 prescription medications a day. The average nursing home resident takes closer to 9. In 2015, Medicare spending on Part D, the prescription drug benefit, is expected to account for 14% of total Medicare expenditures in 2015, or $76 billion.

And while the top ten prescription drugs dispensed to older people include such inexpensive generics as hydrochlorothiazine and atorvastatin, many ultra-expensive specialty drugs are used principally in older people. Some of these drugs are one-of-a-kind; many are life-saving. This is where the concern about undue influence of the manufacturer comes in. Precisely because older people take so many medications (and use so many devices) and precisely because they amount to such a big chunk of health care resources, we need to be concerned with what drugs doctors prescribe. Public disclosure of gifts from PhRMA is unlikely to make much of a difference in the all important power of the pen. 

If we want to assure the integrity of the prescribing process--and this is critical because of the number and cost of the medicines taken by older people--we need to prohibit certain kinds of corporate/physician interactions, and to give such bans teeth.