Big Pharma Gives Millions to Congress

Pharmaceutical companies contribute millions of dollars to U.S. senators and representatives as part of a multipronged effort to influence health care lawmaking and spending priorities. Kaiser Health News (KHN) recently developed a database of contributions by pharmaceutical manufacturers to members of Congress for the past 10 years (1). This was done by examining campaign finance reports from the Federal Election Commission to track donations from political action committees (PACs). The amounts are totaled quarterly and the exact amounts but can change as amendments and refunds are reported. Occasionally, refunds are reported in a different cycle from the original contribution, resulting in a negative total for the cycle. The database can be used to look up any individual candidate or pharmaceutical company and will be updated periodically according to KHN. Contributions to members of Congress from the Southwest states of Arizona, California, Colorado, Hawaii, Nevada and New Mexico are summarized in Appendix 1.

The drug industry ranks among lawmakers' most generous patrons. In the past decade, Congress has received $79 million from 68 pharma political action committees, or PACs, run by employees of companies that make drugs. The amount has steadily increased each year from $11.8 million in 2008 to $15.8 million last year. Since the beginning of last year, 34 lawmakers have each received more than $100,000 from pharmaceutical companies. In the Southwest one of those – Rep. Kevin McCarthy of California, the House Republican majority leader, received more than $200,000 so far this election cycle (2017 and 2018 to date) and has received more than $1,000,000 over the past 10 years (Appendix 1).

While PAC contributions to candidates are limited, a larger donation frequently accompanies individual contributions from the company's executives and other employees. According to Medpage Today, it also sends a clear message to the recipient, one they may remember when lobbyists come calling: “There's more where that came from” (2).

The KHN analysis shows that pharmaceutical companies give generously to a wide swath of lawmakers. Since the beginning of 2017, drug makers contributed to 217 Republicans and 187 Democrats, giving only slightly more on average to Republicans, who currently control both chambers of Congress (2). This was also the case for Democrats during the 2010 election cycle, when they controlled Congress.

Money also tends to flow to congressional committees with jurisdiction over pharmaceutical issues that can affect things like drug pricing and FDA approval. in early 2017, For Example, Rep. Greg Walden from Oregon has watched his coffers swell since he became chairman of the powerful House Committee on Energy and Commerce (1). Walden has received over $278,000 this election cycle. The six members of the committee from Southwest states (Reps. Walters, Eshoo, DeGette, Matsui, McNerney, and Peters) have also received $415,500 to date.

Nearly 50 drug makers made contributions with the amount roughly following the size of the company. Genentech, Pfizer, Amgen, Bristol-Myers Squibb and Eli Lilly were the top 5 over the past 10 years. The PAC for Purdue Pharma, the embattled opioid manufacturer, gave to only a handful of members this cycle. However, it focused much of its giving on lawmakers from North Carolina, its headquarters for manufacturing and technical operations. Insys, the opioid manufacturer from Chandler, Arizona, was not listed as making any contributions.

Campaign contributions tell only part of the story. Drugmakers also spend millions of dollars lobbying members of Congress. So far over $430 million has been spent this election cycle by pharmaceutical companies lobbying Congress (3). Another source is indirect lobbying through to patient advocacy groups, which provide patients to testify on Capitol Hill and organize social media campaigns on drug makers' behalf. A previous investigation by Kaiser Health News, "Pre$cription for Power," examined charitable giving by top drugmakers and found that 14 of them donated a combined $116 million to patient advocacy groups in 2015 alone (4).

Previous studies have suggested that political contributions may influence voting behavior. These sizable contributions may help explain, at least in part, why drug prices in the US are the highest in the world and why Congressional legislation regulating these prices has been so difficult to pass.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Lucas E, Lupkin S.   Pharma cash to Congress. Kaiser Health News. October 16, 2018. Available at: https://khn.org/news/campaign/ (accessed 10/23/18).
2. Huetteman E, Lupkin S. Drugmakers funnel millions to lawmakers. Medpage Today. October 16, 2018. Available at: https://www.medpagetoday.com/washington-watch/electioncoverage/75737?xid=nl_mpt_investigative2018-10-23&eun=g687171d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=InvestigateMD_102318&utm_term=InvestigativeMD (accessed 10/23/18).
3. Pharmaceuticals/health products. OpenSecrets.org. August 28, 2018. Available at: https://www.opensecrets.org/lobby/indusclient.php?id=h04 (accessed 10/23/18).
4. Kopp E, Lucas E, Lupkin S. Pre$cription for power. Kaiser Health News. 2018. Available at: https://khn.org/patient-advocacy/#+initialWidth=1170&childId=patient_advocacy&parentTitle=Pre%24cription%20For%20Power%3A%20KHN%20Patient%20Advocacy%20DatabaseKaiser%20Health%20News&parentUrl=https%3A%2F%2Fkhn.org%2Fpatient-advocacy%2F (accessed 10/23/18).

Cite as: Robbins RA. Big pharma gives millions to Congress. Southwest J Pulm Crit Care. 2018;17(4):117-8. doi: https://doi.org/10.13175/swjpcc113-18 PDF 

Trump Nominates Former Pharmaceutical Executive as HHS Secretary

President Trump on Monday announced Alex Azar, a former pharmaceutical executive, as his choice to succeed Dr. Tom Price as secretary of Health & Human Services (HHS) (1). HHS is an 80,000-employee federal agency that oversees the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the National Institutes of Health, and the Centers for Disease Control and Prevention. Price resigned in September following reports of his extensive use of government and charter air travel.

Azar, a lawyer, formerly headed Eli Lilly & Co.'s U.S. division. Before that, he served as HHS general counsel and deputy secretary during the George W. Bush administration. During that stint, he received praise for his management competence. Azar "will be a star for better healthcare and lower drug prices!" Trump tweeted.

Andy Slavitt, CMS administrator under the Obama administration, also a lawyer and former United Healthcare executive, offered cautious praise for Azar. "I have reason to hope he would make a good HHS secretary," Slavitt said in a written statement. "He ... has real-world experience enough to be pragmatic, and will hopefully avoid repeating the mistakes of his predecessor in over-politicizing Americans' access to healthcare."

If confirmed, Azar would inherit an agency currently torn by political and policy divisions in the wake of Price's departure (2). He will have to make key decisions to avoid further disruption in the individual health insurance market; how much leeway to give states to make big changes in their Medicaid expansion program; and face pressure to address rising prescription drug costs. One management issue Azar would quickly face is how to deal with Price's ambitious Reimagine HHS initiative to streamline the department's operations and with the White House’s proposal to slash the HHS' budget for 2018 by 18%.

Azar has been a sharp critic of the Affordable Care Act, saying in May that the ACA is "fundamentally broken" and "circling the drain." In June, he envisioned the Trump administration shifting the ACA in a more conservative direction even without repeal and replacement of the law. He also has opposed reducing prescription drug prices or allowing purchasing drugs from other countries where prices are lower.

If confirmed, Azar will represent a return to the recent tradition of selecting Secretaries of HHS with no medical background. Before, Price, only Dr. Otis Bowen (1985-9) and Dr. Louis Sullivan (1989-93) were physicians of the 11 non-interim Secretaries.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Meyer H. Can Trump's pick to lead HHS navigate the churning political waters of healthcare? Modern Healthcare. November 13, 2017. Available at: http://www.modernhealthcare.com/article/20171113/NEWS/171119968?utm_source=modernhealthcare&utm_medium=email&utm_content=20171113-NEWS-171119968&utm_campaign=am (accessed 11/14/17).
2. Pradhan R, Diamond D. Price investigation continues to roil HHS. Politico. November 13, 2017. Available at: https://www.politico.com/story/2017/11/13/tom-price-private-jets-probe-hhs-244793 (accessed 11/14/17).

Cite as: Robbins RA. Trump nominates former pharmaceutical executive as HHS secretary. Southwest J Pulm Crit Care. 2017;15(5):221-2. doi: https://doi.org/10.13175/swjpcc140-17 PDF

California Enacts Drug Pricing Transparency Bill

The Mercury News is reporting that California governor Jerry Brown signed a bill Monday making drug pricing more transparent (1). The legislation requires pharmaceutical companies to notify health insurers and government health plans at least 60 days before making price hikes and explain the reason for the increase. The pharmaceutical industry had lobbied hard against the measure, worried that it could become a national model and the first big step toward price controls. “The essence of this bill is pretty simple,” Brown told a room filled with supporters of Senate Bill 17. “Californians have a right to know why their medical costs are out of control, especially when the pharmaceutical profits are soaring. That’s the take-away message.”

“It is disappointing that Gov. Brown has decided to sign a bill that is based on misleading rhetoric instead of what’s in the best interest of patients,” said Priscilla VanderVeer, spokeswoman for the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America. She added that there is “no evidence that SB 17 will lower drug costs for patients.”

The bill does not actually control drug prices, leading some critics to suggest it is toothless. However, the bill’s backers say that transparency in other health care sectors has been successful in reducing costs. Anthony Wright, executive director of Health Access California, agreed. He said the advance notice and information required under SB 17 “is invaluable” to large health care purchasers such as insurers, union trusts and employers, and would enable them to drive a better deal for consumers.

Brown also signed a related bill on Monday. Assembly Bill 265 will prohibit prescription drug manufacturers from offering discounts for name-brand drugs, if a less-expensive equivalent brand is available, preventing the use of higher-priced drugs when unnecessary.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Seipel T. Gov. Brown signs drug pricing transparency bill. The Mercury News. October 8, 2017 (updated October 9). Available at: http://www.mercurynews.com/2017/10/08/gov-brown-to-sign-drug-price-transparency-bill/ (accessed 8/10/17).

Cite as: Robbins RA. California enacts drug pricing trasparency bill. Southwest J Pulm Crit Care. 2017;15(4):159. doi: https://doi.org/10.13175/swjpcc122-17 PDF 

Gottlieb, the FDA and Dumbing Down Medicine

Gottlieb, the FDA and Dumbing Down Medicine

In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7.  However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1). Others praised Gottlieb as the right man to lead the FDA.

As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2). Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight answer when asked to share his thoughts on drug importation. While President Donald Trump has supported increased drug importation and is reported to be working with Democratic lawmakers on drug importation legislation, Dr. Gottlieb had previously opposed the measure (1). When asked if he opposes importing cheaper drugs from foreign countries, he said, "I can tell you I have a lot of ideas that I want to work on right away on how I think we can get more product competition onto the market."

Gottlieb stated that the FDA could speed up approval of new drugs and devices (1). However, a letter to the editor published in the New England Journal of Medicine examined compared review times for new therapeutic agents that were approved by the FDA or the European Medicines Agency (EMA), the primary drug regulator in Europe, between 2011 and 2015 (3). The median total review time was 306 days (interquartile range, 239 to 371) at the FDA, as compared with 383 days (interquartile range, 327 to 446) at the EMA.

In welcome news to many physicians, Gottlieb voiced uneasiness over increasing regulation of physicians’ practices (1). “My concern that the agency was losing confidence in physicians and felt it need[ed] …to supplant their judgment for the judgment of doctors,” Gottlieb said. He had previously referred to the FDA’s action on Arcoxia, a pain killer that was rejected in April 2007 because of concern that it could increase the risk of heart attack and stroke with prolonged use despite being meant for short-term pain relief. Gottlieb stated the opioid epidemic would be his "highest and most immediate priority." He added that the epidemic is a "public health emergency on the order of Ebola and Zika" that requires dramatic action from the FDA. "[T]o address it now, the types of actions that we are going to need to take are going to be more dramatic, perhaps, than the types of actions we would have taken 10 years ago."

Gottlieb did not note that some have linked the present opioid crisis to meddling by bureaucrats, administrations and politicians as an unattended consequence of the pain scale, opioid prescribing guidelines and patient satisfaction ratings (4). Furthermore, he did not note that increasing prescribing authority has been given to non-physicians with less education and clinical experience, e.g., unsupervised nurse practitioners in the Department of Veterans Affairs (5). Whether these non-physician clinicians will use drugs any more or less appropriately than physicians is unclear.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Dickson V. Gottlieb favors regulations that empower doctors while keeping FDA standards. Modern Healthcare. April 5, 2017. Available at: http://www.modernhealthcare.com/article/20170405/NEWS/170409965 (requires subscription, accessed 4/11/17).
2. Dodgson L. Trump has suggested vaccines cause autism — an idea that couldn't be more wrong. Business Insider. January 24, 2017. Available at: http://www.businessinsider.com/trump-vaccines-autism-wrong-2017-1 (accessed 4/11/17).
3. Downing NS, Zhang AD, Ross JS. Regulatory review of new therapeutic agents — FDA versus EMA, 2011–2015. N Engl J Med. 2017Apr 6;376:1386-7. [CrossRef] [PubMed]
4. Robbins RA. Pain scales and the opioid crisis. Southwest J Pulm Crit Care. 2017;14(3):119-22. [CrossRef]
5. Department of Veterans Affairs. VA grants full practice authority to advance practice registered nurses. December 14, 2016. Available at: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2847 (accessed 4/11/17).

Cite as: Robbins RA. Gottlieb, the FDA and dumbing down medicine. Southwest J Pulm Crit Care. 2017;14(4):166-7. doi: https://doi.org/10.13175/swjpcc047-17 PDF