by Reuben A. Guttman and Caroline M. Poplin, M.D., J.D.
Guttman practices law with Guttman, Buschner & Brooks PLLC and was counsel for whistleblowers in cases involving Abbott, Pfizer, GSK, CHS and Pharmerica, among others. Poplin, M.D., J.D., is Medical Director and Of Counsel for Guttman, Buschner & Brooks PLLC and also was involved in cases against Abbott, Pfizer, GSK, CHS and Pharmerica.
In recent months, Planned Parenthood, a health care provider for low-income women, has been under the focused scrutiny of a Congressional oversight committee. Among its many healthcare services, many of which involve preventive care, Planned Parenthood also provides abortions. The organization has been accused in political circles of selling fetal tissue. Though this may be a crime, there have been no criminal indictments let alone convictions and the evidence seems flimsy, if not fabricated, with congressional oversight itself pretextual.
Of course, if Capitol Hill politicians are sincerely interested in looking into how federal dollars are being spent for preventive medicine, care for the nation’s children, and care for the infirmed and the elderly, there are real targets to focus on; targets where billions of dollars have been spent for medical care which, in some cases, has neglected the fundamental tenet that has passed from practitioner to practitioner through the ages: “first, do no harm.”
For starters, look no farther than the pharmaceutical industry where some of the world’s largest drug companies – which feed on funds from Medicare, Medicaid, and the Veterans Administration – have pled guilty to conduct that has admittedly placed lives at risk. Abbott, GlaxoSmithKline, Pfizer, and Johnson & Johnson are just a few of the names that make the list.
In 2012, Abbott Labs pled guilty to violating the Food Drug and Cosmetics Act when it off-label marketed its drug Depakote to the elderly and children for purposes outside of the drug’s FDA-approved indication. In 2013, Janssen Pharmaceuticals – a subsidiary of Johnson & Johnson which makes baby powder and other products – pled guilty to misbranding its billion dollar anti-psychotic drug, Risperdal. Through ongoing litigation and investigation, information about how that drug was marketed is still trickling out to the public and undoubtedly not completely known.
Where would Congress start an investigation? Look no further than big pharma’s representations to Wall Street analysts touting sales goals well exceeding the reasonable revenue streams from the FDA’s approved indication for the product. Juxtapose those goals with company documents challenging company sales reps to meet their “mark,” drill down on the documents showing company-sponsored Hawaiian getaways for employees who exceed sales expectations, and maybe find a few company-sponsored contests which challenge sales teams to spin marketing messages, and the story begins to come into focus. Congressional investigators might also look at big pharma strategies to plant marketing messages in “scientific publications.”
For the legislator whose campaign coffers are so dependent on big pharma dollars to make inquiry a political non-starter, there are the pharmacies that serve the nursing homes. These Long Term Care (LTC) pharmacies are responsible for prudently dispensing prescriptions and providing honest information about pharmaceutical products to the doctors who write them. Notwithstanding their obligation as medical providers, some of the LTC pharmacies – including Omnicare and Pharmerica – have paid millions to settle claims that rebates paid to them by big pharma were no more than bribes to promote a product.
Congressional oversight might start with a look at public filings with the Securities & Exchange Commission which hint at impropriety. Pharmerica’s August 2015 Form 10-K Report filed with the Securities & Exchange Commission discloses that “we currently receive rebates from certain manufacturers and distributors of pharmaceutical products for achieving targets of market share or purchase volumes. Rebates are designed to prefer, protect, or maintain a manufacturer’s products that are dispensed by the pharmacy under its formulary.” It’s actually too bad that most patients don’t think to read SEC filings, and undoubtedly most Wall Street analysts never realize that one day they too may be patients.
Last year, Community Health Systems, which operates more than 100 local hospitals, settled government charges that it schemed to admit patients from the emergency room whose admission was not necessary according to prudent medical practice.
Big pharma, corporate hospital chains, and several publicly traded LTC pharmacies have collectively paid billions to settle these cases. Some of these include repeat offenders. Pfizer and Phamerica, for example, merited new corporate integrity agreements—the corporate equivalent of a return to rehab.
In many cases, the price of wrongful conduct has been measured in the dollars that are spent on unnecessary products and services by federal and state health care plans and sometimes by private payors.
Unfortunately, where drug company promotional activity places a promotional spin on the science of medicine it is difficult, if not impossible, to unscramble and put back together the market for honest medical information. And how does one pinpoint with precision the injury – both short-term and perhaps even latent – attributable to drugs that are administered without medical necessity or prudent instructions for their use? It is indeed a problem. Not to belabor the point: These are also issues about life or the right to life worthy of Congressional oversight.