Even as drug makers are settling or scrambling to resolve disputes with regulators over dubious ways they peddle products, Big Pharma is busting records for its spending to lobby lawmakers on skyrocketing prices, easing industry oversight, and other issues critical not only to the sector but also to tens of millions of consumers.
It’s distressing how news reports continue to show not only the flood of money in prescription drugs but also how medication makers put profit motives ahead of other concerns like the public interest.
Take for example the $280 million that Celgene has agreed to pay to settle fraud claims over its marketing of Thalomid and Revlimid for unapproved uses.
The cancer drugs are the legacy of a medical horror. They’re cousins to thalidomide, the German sedative and anti-nausea medication prescribed in the 1950s and 1960s to thousands of expectant mothers—until researchers linked it to a worldwide wave of birth defects. Thalidomide was yanked from markets and led to major revisions in how regulators test and approve prescription medications.
Doctors later found that thalidomide could be helpful in treating leprosy and immune-related disorders. Celgene spent five years reviving a different formulation of the drug, and getting it approved for treatment of “rare” diseases, which federal regulators define as conditions affecting 250,000 or fewer patients.
But a company whistleblower has brought forth information that Celgene, even before its new versions were approved, had paid doctors, hired copywriters, and prepared to dispatch armies of sales people (which it did) to push “off label” uses of Thalomid and Revlimid, especially in cancer care. Sales of the drugs and yet another successor, Pomalyst, boomed, bringing in more than $8 billion annually.
Although the lawyer representing the whistleblower denounced the company for exploiting desperately ill cancer patients in targeting them with Thalomid and Revlimid, Celgene has denied any wrongdoing. It says it is more sensible for it to settle fraud claims rather than to battle the federal Food and Drug Administration.
That corporate shrug and acceptance of the idea that sizable settlements are just a cost of doing business also may be coming into play for United Therapeutics. It has announced that it has set aside $210 million to resolve federal claims it engaged in kickbacks and false claims in payments to patient charity assistance groups.
United, a Silver Spring, Md.-based drug maker, Johnson and Johnson, Pfizer, and Biogen all are said to be under federal investigation for ostensibly helping patients cover out-of-pocket prescription costs via charity assistance groups. Drug makers have donated to the groups, sums which investigators say may violate laws against kickbacks and false claims. United is the first company to acknowledge the probe, to say it believes it can defend itself against any charges, and to formally set aside money for settlement.
These and other drug maker crackdowns are occurring even as Big Pharma is spending big to lobby lawmakers in Washington, D.C., for regulatory relief, especially as the public clamor grows for Congress to do something about soaring drug costs.
Individual companies, especially those confronting oversight woes, are amping up their lobbying, while Big Pharma’s industry groups —after a hectic first quarter—are raising dues and building war chests heading into the midterm campaigns. Donations to candidates and their political action committees may not surface for a bit yet. But Sanofi, Pfizer, Amgen, Express Scripts, and AbbVie are the leading pharma donors in the first half of 2017, with each giving members of Congress tens of thousands of dollars.
The independent, nonpartisan Kaiser Health News Service deserves credit for developing a data base on pharmaceutical companies’ lobbying expenditures, an effort that already has offered a revealing look at how Mallinckrodt is responding to public and regulators’ scrutiny of its opioid painkillers and a drug for which it hiked the price to $34,000 a vial.
In my practice, I see the harms that patients suffer while seeking medical services and the damages that dangerous drugs can cause, as well as the heartbreaking struggles that too many Americans go through to try to afford exorbitantly priced prescription medications. It’s sad to see how fast and far President Trump has run from his pronouncements about how Big Pharma “gets away with murder” and how he would get drug prices down. Congress, meantime, has jammed itself up so badly with majority Republicans’ failed efforts to repeal and replace the Affordable Care Act, aka Obamacare, that lawmakers may be months away from even starting to try to curb high drug prices.
They’re out of control and maddening, as well illustrated by Elisabeth Rosenthal, a non-practicing doctor, former New York Times reporter, and author of an excellent book on the runaway costs of America’s corporatized medical care. She’s penned a small piece about the crazy obstacle course she ran to get a relative a common, basic but now prescription med. Her frustration grew as she found that a dozen doses might cost her as much as $190, while she can get on a London visit the comparable drug, over the counter, in an apothecary, for $7.50. As she walks through the (lame) cost justifications, inquiring minds will, no doubt, be devising other suitable places and recipients for the med in question—torpedo-shaped, hydrocortisone suppositories for hemorrhoid care.