Big Pharma's bribery and corruption linked to opioid epidemic

The Guardian
How big pharma's money--and its politicians--feed the US opioid crisis
Tom Marino might have withdrawn from consideration as Trump's drug czar but drug money is coursing through the veins of Congress-- contributing directily to an epidemic that kills thousands of Amerians each year
 The pharmaceutical industry attempted to place blame for the crisis on the millions who have became addicted instead of the mass prescribing of powerful opioids. Photograph: Dominick Reuter/AFP/Getty Images
Chris McGreal in Washington
Donald Trump was not wrong. Hours before his nominee for “drug czar” withdrew from consideration over his part in a law limiting the Drug Enforcement Administration’s ability to crack down on pharmaceutical distributors feeding the US’s opioid epidemic, the president took a shot at the influence of drug companies over Congress.
“They contribute massive amounts of money to political people,” he said, standing next to Mitch McConnell, the Senate majority leader.
“I don’t know, Mitch, maybe even to you,” he added.
Trump was right on both counts. Pharmaceutical companies spend far more than any other industry to influence politicians. Drugmakers have poured close to $2.5bn into lobbying and funding members of Congress over the past decade.
Hundreds of thousands of dollars have gone to McConnell – although he is hardly alone. Nine out of 10 members of the House of Representatives and all but three of the US’s 100 senators have taken campaign contributions from pharmaceutical companies seeking to affect legislation on everything from the cost of drugs to how new medicines are approved.
Trump’s nominee for drug czar, the US congressman Tom Marino, was forced to withdraw after a report by the Washington Postand CBS’s 60 Minutes highlighted his role in forging legislation that hinders the DEA’s ability to move against drug distributors or pharmacies recklessly dispensing the opioid painkillers at the heart of the epidemic, which claims more than 100 lives a day.
Marino’s acceptance of substantial donations from those same companies compromised his nomination to head the federal agency charged with tackling the opioid crisis.
But for Congress, the process was nothing unusual. Hundreds of millions of dollars flow to lobbyists and politicians on Capitol Hill each year to shape laws and policies that keep drug company profits growing. The pharmaceutical industry, which has about two lobbyists for every member of Congress, spent $152m on influencing legislation in 2016, according to the Center for Responsive Politics. Drug companies also contributed more than $20m directly to political campaigns last year. About 60% went to Republicans. Paul Ryan, the speaker of the House of Representatives, was the single largest beneficiary, with donations from the industry totaling $228,670.
The impact of so much drug company money coursing through the veins of Congress is often incremental or largely unseen by the American public, such as the industry’s efforts to block competitors in India from making generic versions of HIV/Aids medicines that are more affordable to developing countries.
But on occasion it has a hugely visible impact.
In his comments alongside McConnell, Trump was vocal in his criticism of what he said were pharmaceutical manufacturers “getting away with murder” by charging much higher prices in the US than other countries. That is the result of a 2003 law, in effect written by the industry, preventing the federal government from seeking bids for the manufacture of drugs and medical devices – a process used in other areas, such as defence spending.
Instead, the pharmaceutical companies can charge whatever price they want for drugs bought for the publicly run Medicare and Medicaid programmes – and the federal government has no choice but to pay up.
Meanwhile, the drug companies say that to allow foreign imports would endanger the quality and safety of medicines in the US. But that justification has been widely scorned in the face of escalating and sometimes opportunistic pricing, such as the surge in the price of EpiPen antidotes to allergic reactions last year, to $600.
Britain’s National Health Service negotiated a price of about $70 for the same product. Scores of attempts by some members of Congress to introduce legislation to bring down the price of prescription medicines or to let people buy them from Canada, where they are often cheaper, have failed to make it out of committee.
While lobbying shapes medical policy across the board, it has had a profound impact on the opioid epidemic as deaths quadrupled between 1999 and 2015. The pharmaceutical industry poured resources into attempting to place blame for the crisis on the millions who have became addicted instead of on the mass prescribing of powerful opioids.
The relatively small number of members of Congress who led the charge against the epidemic years before it became a significant political issue have struggled to push through legislation.
Representatives Hal Rogers and Mary Bono saw repeated efforts to pass laws curbing the mass prescribing of opioid painkillers fail amid concerted campaigns by the drug makers. Rogers and Bono founded the Congressional Caucus on Prescription Drug Abuse in 2010 and proposed several pieces of legislation over a number of years.
Bono, who was alerted to the opioid crisis after Chesare, her son with the late singer Sonny Bono, became addicted, said there was a false but effective campaign by companies profiting from the epidemic to portray any attempt to rein in the mass prescribing of painkillers as depriving millions of people of legitimate treatment for chronic pain.
“We were getting tremendous pushback from the industry. It was a massive, well-organised effort,” she said. “Of course we felt it, maybe indirectly at times. We didn’t have an awful lot of people lining up to help us.”
Some of the pressure came through industry-funded groups such as the Pain Care Forum, which spent $740m over a decade lobbying in Washington and state legislatures against limits on opioid prescribing and similar issues, according tothe Center for Public Integrity.
Among those who received political contributions from the group were Senator Orrin Hatch, who took $360,00. The senator introduced legislation intended to head off one of the bills put forward by Rogers and Bono by proposing a federal study of pain treatment. Hatch, who is running for Senate again in 2018 even though he previously said he would not, is the recipient of the most political donations from the pharmaceutical industry so far this year, at $208,000.
Bono said the American Medical Association was instrumental in blocking another law, the Ryan Creedon act, to require doctors to get training on the risks of opioids. The AMA objected to it as a burden on physicians.
Drug companies gave more than $200,000 in campaign contributions to Jason Chaffetz (who recently left Congress), acting as the single largest donor to his re-election fights. Chaffetz, as chair of the committee on oversight and government reform, led an effort against the Centers for Disease Control and Prevention to reduce opioid prescribing by recommending that doctors first seek alternative treatments for chronic pain.
Lobbying by the wider healthcare industry also had an important impact on the shape of Barack Obama’s Affordable Care Act (ACA), widely known as Obamacare.
The chair of the committee drafting the ACA legislation, Senator Max Baucus, was at the time the single largest recipient of health industry political donations, with $1.5m given to his political fund over the previous year. Baucus led votes in the committee against the inclusion in the legislation of public insurance strongly opposed by private insurers who saw a threat to its profits.
Baucus was known within the health industry for annual fly-fishing and golfing weekends in his home state of Montana that lobbyists paid handsomely to attend. Other members of the committee received hundreds of thousands of dollars, including Senator Pat Roberts, who at one point tried to hold up the bill by claiming lobbyists needed three days to read it. The drafting of large parts of the ACA was done by a former vice-president of a major health insurer, Wellpoint.
In his attack on drug company money in American politics, Trump failed to mention that the companies were among the leading donors to his inauguration alongside tobacco and oil companies.
Pfizer, the maker of Viagra, was the largest pharmaceutical donor, giving $1m.



New England Journal of Medicine
Medicare Part D — The Product of a Broken Process
Louise M. Slaughter, M.P.H.
Most Americans agree that affordable drug coverage under Medicare has been needed for some time. But instead of a solution to a growing problem, Congress gave the country a prescription-drug plan that achieves few of its original goals. The current problems with Medicare Part D are largely the direct result of the undemocratic way in which the plan was authored and passed. The final legislation, heavily influenced by drug-company and health insurance lobbyists, focused mainly on the needs of those industries instead of those of the seniors it should serve.
The political process used to pass Part D was the worst abuse of the legislative process I have seen during my 20 years in Congress. In the months before its passage, a few powerful Republican leaders worked to undermine conscientious reform proposals. In early 2003, while the House bill was being drafted, Democrats and Republicans authored 59 sensible amendments to it. At the behest of the Republican leadership, however, the House Committee on Rules rejected all but one, preventing them from being debated by Congress. Many of those amendments — among them, one requiring the administration to use beneficiaries' collective purchasing power to negotiate lower prices and one allowing Americans to import cheaper drugs from Canada — would have made the legislation far more effective and probably would have received bipartisan support, had they been allowed onto the floor.
Next, the conference process, whereby the House and Senate versions of legislation are reconciled, was fundamentally corrupted and kept almost entirely secret by senior Republicans. Democrats on the conference committee were excluded from deliberations, to the point of being physically barred from the conference room on one occasion. The pharmaceutical industry, however, was invited in.
Serious conflicts of interest on the part of the bill's primary authors were common. The chairman of the Commerce Committee, Representative Billy Tauzin (R-La.), coauthored the bill while negotiating a $2-million-per-year job as a lobbyist for the Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry's trade organization. The top Republican aide on a subcommittee involved in writing the legislation also left his position soon afterward to lobby for PhRMA. Thomas Scully, the administration's top Medicare official, deliberately understated the program's projected cost by $134 billion, and when the chief actuary of the Centers for Medicare and Medicaid Services (CMS) objected, Scully reportedly threatened to fire him if he shared his true estimate with Congress. Soon after the legislation passed, Scully resumed his career as a health care–industry lobbyist.
When the conference report was brought to the House for a vote, members were given less than one day to read the 850-page bill, a violation of House rules. When the vote was called at almost 3 a.m., voting Democrats stood unanimously with 22 Republicans in opposing the legislation. Had the vote been gaveled down in the customary 15 minutes, the bill would not have passed. So the Republican leadership held the vote open for a record three hours while attempting to change the outcome — through intimidation and other tactics that, again, violated House rules. Finding itself with a narrow lead at 5:53 a.m., the Republican leadership immediately brought the vote to a close.
Many abuses undoubtedly took place that night. Representative Nick Smith (R-Mich.) later revealed what may have been the worst: that former Majority Leader Tom DeLay (R-Tex.) and Representative Candice Miller (R-Mich.) tried to bribe him with political favors to change his vote — an infraction for which the House Ethics Committee later admonished them. Through these means, the Republican leadership succeeded in passing a bill whose goal was, according to Representative Bill Thomas (R-Calif.), to “end Medicare as we know it.”1
Thomas's words proved as prophetic as they were ironic. Part D works better for the pharmaceutical and insurance industries than for beneficiaries. Drug-industry lobbyists worked to prevent the reimportation of cheaper medications from Canada and to add patent protection against generic drug makers. Independent analysts predicted that with such victories, the bill would increase drug-industry profits by $139 billion over the next eight years.2
The elderly and disabled, pharmacists, nursing homes, and families, for their part, have been burdened by a flawed plan that was not drafted with them in mind. Unlike existing government health plans, Part D does not allow the administration to negotiate drug prices with pharmaceutical companies. As a result, these companies are charging taxpayers up to 80 percent more for drugs purchased under Part D than for those purchased under other plans.
Millions of seniors had to enroll in a plan by an arbitrarily selected deadline or face premium increases for each month beyond it — an incentive that clearly benefits insurance companies. Seniors have had little time to choose among plans. And these plans may change drug formularies whenever they want to, without penalty. Doctors, not insurance-company bureaucrats, should be deciding which drugs their patients need, but that fundamental premise of responsible health care was thwarted by this legislation.
Part D is a costly endeavor for patients, states, and consequently taxpayers. The bill requires beneficiaries to pay a $250 deductible and 25 percent of their annual drug costs up to $2,250. They must then cover all annual expenses between $2,251 and $3,600. This “doughnut hole” rule will cost patients a substantial amount of money.
States, already overburdened by health care costs, are required to partially fund Part D. Some states are actually losing money under it, because the formula used to calculate their share is based on a per capita cost for people eligible for both Medicare and Medicaid (“dual-eligibles”).
Implementation of the program was barely considered in the effort to push the bill through Congress, and chaos has ensued. Seniors and their families remain confused about which plans to choose. And many states have had to declare emergencies to ensure that dual-eligibles continued to receive their medications. Lack of communication of key rules to telephone operators at Medicare's toll-free patient hotline has resulted in the failure to provide needed medication to many beneficiaries on time. In addition, faulty CMS eligibility data have resulted in regular denials of prescriptions; and both beneficiaries and pharmacists are regularly paying out-of-pocket costs to ensure continuity of treatment.
Part D has not yet fulfilled its basic promise: to make Medicare's drug coverage closer to universal, especially among the neediest Americans. At least six million Medicare beneficiaries without drug coverage had still not enrolled as of late April. More important, more than 80 percent of beneficiaries in the lowest income bracket had yet to enroll.
The flaws in the legislation and failures in implementation result directly from the conflicts of interest in the drafting of the bill and a corrupted legislative process. In my estimation, the Medicare Prescription Drug and Modernization Act of 2003 violates the tradition, spirit, and intent of Medicare. Americans are now subsidizing insurance and pharmaceutical companies through tax dollars and out-of-pocket expenses, while receiving low-quality care.
Several short-term fixes are obvious. The Secretary of Health and Human Services ought to negotiate directly for lower drug prices, and we need to simplify the types of plans offered and eliminate the doughnut-hole rule. Democrats have fought for these changes and have pledged to take Part D back to the drawing board, should we get the opportunity.
But more broadly, we must reform the way our government does business. Accountability and transparency must be returned to Congress, and free debate and consideration of critical issues must be restored to its halls.
Ms. Slaughter (D-N.Y.) is a member of the House of Representatives and currently serves as the ranking member of the House Committee on Rules.