Tagged U.S. Congress

Congressman’s Ties To Foreign Biotech Draw Criticism

When a small Australian biotechnology company, Innate Immunotherapeutics, needed a clinical trial for an experimental drug it hoped to turn into a huge moneymaker, the company landed a U.S. partner where it had high-level connections: Roswell Park Cancer Institute in Buffalo, N.Y.

The company is partly owned by Rep. Chris Collins, a wealthy Republican entrepreneur from Buffalo, whose enthusiasm for Innate helped persuade others to invest. Former Rep. Tom Price, now secretary of Health and Human Services, bought Innate stock after Collins told him about it, Price said at his Senate confirmation hearing. Other shareholders include Collins’ campaign supporters, some of whom are key figures in Buffalo’s medical corridor, company and government documents reveal.

Federal money is in play, too: National Cancer Institute funds are being used to test an application for Innate’s drug that could make the company more attractive to potential buyers. Innate has said in presentations to investors that it hopes to sell itself to a major pharma company by the end of 2017.

The Roswell clinical trial, which could start this month, will investigate whether MIS416 might have an application as an ingredient in a vaccine for ovarian cancer. Innate’s primary strategy, however, is to develop the drug for advanced multiple sclerosis and it has told investors that the results of early-stage human trials in Australia and New Zealand against MS will be reported by this fall.

With its tangled web of medicine, politics and money, Innate’s story has proven irresistible for U.S. news media, whose initial reports in December that Price received discounts on Innate stock purchases helped place the secretary on the hot seat as he won confirmation. Now, the story is exploding half a world away, and the focus is shifting to Collins. The Australian newspaper’s website reported Feb. 6 that a former securities regulator there alleged Collins may have violated disclosure requirements in the country’s securities laws in acquiring his Innate stake and also by not reporting his close relationships with other large shareholders. The Australian government’s Takeovers Panel said Feb. 15 that it has not decided whether to convene a panel to investigate the allegations.

Innate CEO Simon Wilkinson said in a statement that company financial documents “fully informed” financial markets about Collins’ investments. The company was “not in the slightest bit concerned” about the allegations, which “are politically motivated and have been peddled by hack journalism,” he said.

Compared with Price, the potential conflicts could run even deeper for Collins who — along with two children — owns more than 21 percent of Innate’s shares. He is its largest shareholder, company reports show.

Collins, who is ranked by the Center for Responsive Politics as the 14th-wealthiest member of Congress, sits on the health subcommittee of the Energy and Commerce Committee, where he helps oversee health care funding. He was a member of President Donald Trump’s transition team and is a liaison between the new administration and Capitol Hill.

Congressional ethics rules do not prohibit Collins and other members from investing in companies whose businesses overlap with the committees they serve on and the government agencies those committees oversee, legal experts said. Even so, they added, members must take care to disclose possible conflicts of interest because they can erode the public’s trust in government.

“Members should not have large holdings in health care stocks while serving on committees that oversee health policy,” said Richard Painter, former chief ethics lawyer for President George W. Bush.

Collins’ spokesman said his boss has done nothing improper.

“Congressman Collins is not going to apologize because a company he has a relationship with is attempting to help conquer cancer,” said Collins communications director Michael McAdams. “It’s sad the media is attempting to launch partisan attacks insinuating otherwise.”

‘I Talk About It All The Time’

Collins has been candid about his promotional efforts on Innate’s behalf.

In an interview with CNN, Collins said he often talks to people about Innate. “I talk about it all the time, just as you would talk about your children,” he said.

Last month, Collins was overheard by reporters boasting on a cellphone call just off the House floor about the “many millionaires” he had made talking up Innate, according to Politico.

Innate’s drug is an immune response stimulator discovered in the 1990s that had initially been developed as a potential treatment for HIV/AIDS or to boost the efficacy of childhood vaccines.

Founded in 2000, the company later tried MIS416 in a number of medical uses, but never found a marketable niche, Innate’s financial reports and news reports show.

Collins’ ties to Innate go back to 2005 — seven years before he was first elected to Congress — when the successful Buffalo businessman decided to invest after meeting Wilkinson while the CEO was in the U.S. seeking investors, Wilkinson said.

Collins joined the board in 2006 and the company first sold shares to the public in 2013. From 2013 to 2016, he bought Innate shares then worth between $3.5 million and $16 million and has not sold any, according to his congressional disclosure statements. Collins now owns nearly 38 million shares of the company, worth about $25 million based on the stock’s recent closing prices on the Australian stock exchange. That price peaked at $1.35 a share on Jan. 25 and is now under $1.

Innate has never had a revenue-producing product and has relied mainly on investor capital for funds. The congressman made four personal loans to Innate in 2012 and 2013 totaling $1.3 million that were later converted to shares and options to buy more shares at discounted prices, according to company financial reports.

Collins also promoted Innate among people in his professional and social circles, drawing investors whose share purchases have helped keep the company afloat.

Americans own 44 percent of Innate, according to a company-funded research report on its website. Many of those shareholders seem to come from an interconnected circle of prominent Buffalo investors with Collins at the center, based on company documents, congressional disclosure statements and political contributions reported in Federal Election Commission filings.

Investors who bought stock in two private placements by Innate have contributed at least $105,000 to Collins’ congressional campaigns, according to the Public Accountability Initiative in Buffalo, a nonprofit that investigates politics and government, which compared an Innate shareholders’ document with FEC filings.

One was Glenn Arthurs, an executive in the Buffalo office of UBS, the Swiss financial services giant. Another was Paul Harder, who runs a private investment firm in Buffalo, CHEP II. Arthurs and CHEP II both ranked among Innate’s top 20 shareholders last year, according to the company’s annual report. Both have also contributed to Collins since 1998, the year of his first — and unsuccessful — congressional campaign, FEC records show.

Collins’ congressional chief of staff, Michael Hook, who began working for Collins early last year, bought shares of Innate 28 times last year, according to his disclosure statements. Sometimes he purchased thousands of dollars of stock multiple times in a single day, those filings show.

Bill Paxon, a former congressman from Buffalo and a lobbyist whose clients include PhRMA, the major drug makers’ trade group, has invested in Innate. So has Lindy Ruff, the former coach of the Buffalo Sabres hockey team, who is now head coach of the Dallas Stars. Both were identified in a public company document for shareholders.

Ruff declined to comment on his Innate investment. Paxon, Arthurs, Harder and Hook did not reply to repeated requests from KHN for comment.

Mark Lema, Roswell’s head of anesthesiology, told The Buffalo News recently that he became an Innate investor after overhearing Collins discussing it at a meeting for Buffalo visitors that Collins hosted in Washington, D.C. But he’s never discussed Innate or MIS416 with study researchers at Roswell, he said in a subsequent interview with KHN.

A Complaint In Australia

Recent published reports in the U.S. detailing Collins’ ties with Innate are what provoked Sydney lawyer — and Innate shareholder — James Wheeldon to question Collins’ adherence to Australian securities laws, according to the 10-page letter that he sent Feb. 3 to Innate and the Australian Securities and Investment Commission.

Wheeldon alleged that Collins failed to disclose his large holdings in Innate to the Australian Securities Exchange within two business days of becoming a substantial stockholder, as the country’s law requires.

Stating that Collins owned more than 15 percent of the company before Innate went public in December 2013, Wheeldon alleged that Collins did not inform the exchange how much he owned until almost 18 months later.

Wheeldon also said that published reports about Collins’ “family, professional, political and financial relationships” with other Innate shareholders like Price had never been disclosed to the Australian financial market to his knowledge, “but rather has only come to light as a consequence of these press reports.”

Collins, his children, political allies and his donors control at least 27.25 percent of the company — giving Collins greater influence over the company than has been disclosed to shareholders, Wheeldon wrote.

“Mr. Collins duty is not to enrich the business and political elite of Buffalo, New York. His overarching duty is to the company,” read Wheeldon’s letter.

The stakes may be high, but the data from the Roswell study might not produce strong conclusions. Twelve people will be in the study, which is to be completed in August 2018, according a listing on clinicaltrials.gov. The start of the trial has been postponed five times since July and is now scheduled for this month. Recruiting for participants has not started yet, according to the listing.

Innate and Roswell began collaborating in 2009 and as both sides tell the story, Collins — the man who first connected the Australian biotech firm to Buffalo — had nothing to do with it. According to Roswell, the doctor running the trial, Kunle Odunsi, learned about MIS416 that year when Wilkinson, the CEO, pitched the drug at a presentation in Buffalo to prospective collaborators. Roswell researchers have been testing the vaccine in mice with tumors since first receiving the National Cancer Institute grant in 2011.

The trial is called an “investigator-initiated” trial, meaning that Odunsi has an agreement with Innate to explore the use of MIS416 for a cancer vaccine for free. Innate donates the drug, Roswell sponsors for the trial and if it’s successful, researchers could approach a medical journal to publish the results.

“A publication by a reputable clinical center (e.g., Roswell) in a prestigious journal […] would almost certainly increase off-label usage, thus increasing sales,” Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, wrote in an email.

Wilkinson said Collins has played no role in lining up the clinical trial at Roswell or getting the NCI funds to pay for it. McAdams, Collins’ spokesman, said Collins had “zero involvement” in the grant.

Categories: Health Industry, Syndicate

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Right-To-Die Fight Hits National Stage

Opponents of aid-in-dying laws are claiming a small victory. They won the attention of Congress this week in their battle to stop a growing movement that allows terminally ill patients to get doctors’ prescriptions to end their lives.

The Republican-led effort on Capitol Hill to overturn the District of Columbia’s aid-in-dying law could fail by Friday. But advocates worry the campaign will catalyze a broader effort to fully ban the practice, which is legal in six states and being considered in 22 more.

“The D.C. legislation has catapulted the issue of medical aid in dying onto the federal agenda at a time when Congress has the power to enact a ban on this end-of-life care option nationwide — even criminalizing the practice in the six states where this option is currently authorized,” warned Jessica Grennan, national director of political affairs and advocacy for Compassion & Choices, which supports right-to-die laws.

“If that happens, it will set the end-of-life care movement back to the last century,” Grennan said.

No matter how the effort plays out, both sides agree that the debate on Capitol Hill, featuring a Republican moral protest, could be only a taste of what’s to come.

In a vote that hewed closely to party lines, the Republican-controlled House Oversight Committee on Monday approved a bill that would knock down D.C.’s law, which won approval from the mayor and City Council in December. While D.C.’s law mirrors those passed in other states, Congress has unique power to intervene in D.C.’s affairs. Under the Home Rule Act of 1973, Congress has 30 legislative days to overturn any law D.C. passes.

“It’s of deep, personal moral conviction that I stand in opposition” to D.C.’s law, said Rep. Jason Chaffetz of Utah, who chairs the committee, in Monday’s hearing.

The clock is running out on his effort. Republicans in the House and Senate have introduced joint resolutions attempting to block D.C.’s law, but the bills would need to pass the full House and Senate and gain President Donald Trump’s signature. Trump has declined to take a public stance on the matter. If those steps don’t happen by Friday, D.C.’s law will take effect.

Dr. David Stevens, CEO of the Christian Medical & Dental Associations, which opposes medical aid in dying, said even if Republicans fail to overturn D.C.’s law, their efforts may have broader impact.

“As representatives and senators become more educated about the dangers of physician-assisted suicide,” Stevens said, “I wouldn’t be surprised” if members of Congress introduce laws to “prohibit or at least more closely regulate” the practice.

(Courtesy of Amazon.com)

(Courtesy of Amazon.com)

If Congress passes such a law, the only hope for advocates such as Grennan “would be for the Supreme Court to intervene,” she said. But she noted that Trump’s pick for the Supreme Court, Neil Gorsuch, a federal appellate judge on the U.S. Court of Appeals for the 10th Circuit, has published a book against aid-in-dying efforts. The book, she said, notes “the Supreme Court’s power to overturn the state medical aid-in-dying laws.”

Away from Capitol Hill, the aid-in-dying movement has gained steam: The practice is legal in Oregon, Washington, Vermont, Colorado, California and Montana.

Energized by victories in California and Colorado last year, aid-in-dying supporters are pushing ahead to battlegrounds nationwide. So far this year, 21 states have introduced aid-in-dying legislation, according to Compassion & Choices. And in South Dakota, proponents are trying to get the practice approved through a ballot initiative.

Hawaii, Maryland and Maine appear the most likely to pass new legislation this year, said Peg Sandeen, executive director of the Death With Dignity National Center, another national advocacy group.

But opponents have beaten back similar measures in many states in recent years. And in Alabama, South Dakota and New York, they have gone on the offensive, introducing bills to preemptively outlaw the practice or prohibit insurance from paying for the lethal drugs.

Chaffetz, who is leading the charge to overturn D.C.’s law, has enraged Democrats and D.C. officials, who accuse him of overreaching his power by meddling in local affairs. But Chaffetz and fellow House Republicans at Monday’s vote said moral concerns trump local autonomy.

“Only God gets to decide” when a person’s life ends, declared Rep. Paul Mitchell, a Michigan Republican, during the debate.

If Republicans fail this week, they could attack D.C.’s Death With Dignity law in April, when Congress approves D.C.’s proposed budget. D.C. has proposed to spend some local money to build a database tracking the assisted-dying program.

Republican Sen. James Lankford of Oklahoma, who introduced the Senate resolution blocking the bill, also made a legal argument, citing a 1997 law passed under President Clinton that bans the use of federal money for physician-assisted death. Because of that law, Medicare and the Department of Veterans Affairs do not pay for the lethal drugs, so patients must pay out-of-pocket or use private or state-funded insurance. Lankford challenged D.C. to show that its assisted-dying program wouldn’t conflict with that law.

Advocates dismissed that argument. Sandeen, of the Death With Dignity National Center, said D.C.’s program will not use any federal money to help people die. She called the legal argument a “red herring effort,” aimed at distracting attention from politicians’ true reasons for trying to strike down D.C.’s law.

“I’d rather that they said, ‘For religious purposes, I disapprove of this law,’” she said.

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

Categories: Aging, Mental Health, Syndicate

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Docs Bill Medicare for End-of-Life Advice As ‘Death Panel’ Fears Reemerge

End-of-life counseling sessions, once decried by some conservative Republicans as “death panels,” gained steam among Medicare patients in 2016, the first year doctors could charge the federal program for the service.

Nearly 14,000 providers billed almost $35 million — including nearly $16 million paid by Medicare — for advance care planning conversations for about 223,000 patients from January through June, according to data released this week by the Centers for Medicare & Medicaid Services. Full year figures won’t be available until July, but use appears to be higher than anticipated.

Controversy is threatening to reemerge in Congress over the funding, which pays doctors to counsel some 57 million Medicare patients on end-of-life treatment preferences. Rep. Steve King, R-Iowa, introduced a bill last month, the Protecting Life Until Natural Death Act, which would revoke Medicare reimbursement for the sessions, which he called a “yet another life-devaluing policy.”

“Allowing the federal government to marry its need to save dollars with the promotion of end-of-life counseling is not in the interest of millions of Americans who were promised life-sustaining care in their older years,” King said on Jan. 11.

While the fate of King’s bill is highly uncertain — the recently proposed measure hasn’t seen congressional action — it underscores deep feelings among conservatives who have long opposed such counseling and may seek to remove it from Medicare should Republicans attempt to make other changes to the entitlement program.

Proponents of advance care planning, however, cheered evidence of program’s early use as a sign of growing interest in late stage life planning.

“It’s great to hear that almost a quarter million people had an advance care planning conversation in the first six months of 2016,” said Paul Malley, president of Aging with Dignity, a Florida nonprofit. “I do think the billing makes a difference. I think it puts it on the radar of more physicians.”

Use of the counseling sessions are on track to outpace an estimate by the American Medical Association, which projected that about 300,000 patients would receive the service in the first year, according to the group, which backed the rule.

Providers in California, New York and Florida led use of the policy that pays about $86 a session for the first 30-minute office-based visit and about $75 per visit for any additional sessions.

The rule requires no specific diagnosis and sets no guidelines for the end-of-life discussions. Conversations center on medical directives and treatment preferences, including hospice enrollment and the desire for care if patients lose the ability to make their own decisions.

The new reimbursement led Dr. Peter Sutherland, a family medicine physician in Morristown, Tenn., to schedule more end-of-life conversations with patients last year.

“They were very few and far between before,” he said. “They were usually hospice-specific.”

Now, he said, he has time to have thorough discussions with patients, including a 60-year-old woman whose recent complaints of back and shoulder pain turned out to be cancer that had metastasized to her lungs. In early January, he talked with an 84-year-old woman with Stage IV breast cancer.

“She didn’t understand what a living will was,” Sutherland said. “We went through all that. I had her daughter with her and we went through it all.”

The conversations may occur during annual wellness exams, in separate office visits or in hospitals. Nurse practitioners and physicians’ assistants may also seek payment for end-of-life talks.

The idea of letting Medicare reimburse such conversations was first introduced in 2009 during debate on the Affordable Care Act. The issue quickly fueled allegations by some conservative politicians, such as former Republican vice presidential candidate Sarah Palin and presidential candidate John McCain, that they would lead to “death panels” that could disrupt care for elderly and disabled patients.

The idea was dropped “as a direct result of public outcry,” King said in a statement.

“The worldview behind the policy has not changed since then and government control over this intimate choice is still intolerable to those who respect the dignity of human life,” he said.

But in 2015, CMS officials quietly issued the new rule allowing Medicare reimbursement as a way to improve patients’ ability to make decisions about their care.

End-of-life conversations have occurred in the past, but not as often as they should, Malley said. Many doctors aren’t trained to have such discussions and find them difficult to initiate.

“For a lot of health providers, we hear the concern that this is not why patients come to us,” Malley said. “They come to us looking to be cured, for hope. And it’s sensitive to talk about what happens if we can’t cure you.”

2014 report by the Institute of Medicine, a panel of medical experts, concluded that Americans need more help navigating end-of-life decisions. A 2015 Kaiser Family Foundation poll found that 89 percent of people surveyed said health care providers should discuss such issues with patients, but only 17 percent had had those talks themselves. (KHN is an editorially independent program of the foundation.)

Use of the new rule was limited in the first six months of 2016. In California, which recorded the highest Medicare payments, about 1,300 providers provided nearly 29,000 services to about 24,000 patients at an overall cost of about $4.4 million — including about $1.9 million paid by Medicare.

The data likely reflect early adopters who were already having the talks and quickly integrated the new billing codes into their practices, said Dr. Ravi Parikh, an internal medicine resident at Brigham and Women’s Hospital in Boston, who has written about advance care planning. Many others still aren’t aware, he said.

Data from Athenahealth, a medical billing management service, found that only about 17 percent of 34,000 primary care providers at 2,000 practices billed for advance care planning in all of 2016.

The numbers will likely grow, said Malley, who noted that requests from doctors for advance care planning information tripled during the past year.

To counter objections, providers need to ensure that informed choice is at the heart of the newly reimbursed discussions.

“If advance care planning is only about saying no to care, then it should be revoked,” Malley said. “If it truly is about finding out patient preferences on their own turf, it’s a good thing.”

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

Categories: Medicare, Syndicate

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Influence of GOP Doctors Caucus Grows as Congress Looks to Replace Health Law

The confirmation of Tom Price, the orthopedic surgeon-turned-Georgia congressman, as secretary of Health and Human Services represents the latest victory in the ascendancy of a little-known but powerful group of conservative physicians in Congress he belongs to — the GOP Doctors Caucus.

During the Obama administration, the caucus regularly sought to overturn the Affordable Care Act, and it’s now expected to play a major role determining the Trump administration’s plans for replacement.

Robert Doherty, a lobbyist for the American College of Physicians, said the GOP Doctors Caucus has gained importance with Republicans’ rise to power. “As political circumstances have changed, they have grown more essential,” he said.

“They will have considerable influence over the considerable discussion on repeal and replace legislation,” Doherty said.

Price’s supporters have touted his medical degree as an important credential for his new position, but Price and the caucus members are hardly representative of America’s physician in 2017. The “trust us, we’re doctors” refrain of the caucus obscures its heavily conservative agenda, critics say.

“Their views are driven more by political affiliation,” said Mona Mangat, an allergist-immunologist and chair of Doctors for America, a 16,000-member organization that favors the current health law. “It doesn’t make me feel great. Doctors outside of Congress do not support their views.”

For example, while the American College of Obstetrics and Gynecology has worked to increase access to abortion, the three obstetrician-gynecologists in the 16-member House caucus are anti-abortion and oppose the ACA provision that provides free prescription contraception.

While a third of the U.S. medical profession is now female, 15 of the 16 members of the GOP caucus are male, and only eight of them are doctors. The other eight members are from other health professions, including a registered nurse, a pharmacist and a dentist. The nurse, Diane Black of Tennessee, is the only woman.

On the Senate side, there are three physicians; all of them Republican.

While 52 percent of American physicians today identify as Democrats, just two out of the 14 doctors in Congress are Democrats.

About 55 percent of physicians say they voted for Hillary Clinton and only 26 percent voted for Donald Trump, according to a survey by Medscape in December.

Meanwhile, national surveys show doctors are almost evenly split on support for the health law, mirroring the general public. And a survey published in the New England Journal of Medicine in January found almost half of primary care doctors liked the law, while only 15 percent wanted it repealed.

Rep. Michael Burgess, R-Texas, a caucus member first elected in 2003, is one of the longest serving doctors in Congress. He said the anti-Obamacare Republican physicians do represent the views of the profession.

“Doctors tend to be fairly conservative and are fairly tight with their dollars, and that the vast proportion of doctors in Congress [are] Republican is not an accident,” Burgess said.

Price’s ascendancy is in some ways also a triumph for the American Medical Association, which has long sought to beef up its influence over national health policy. Less than 25 percent of AMA members are practicing physicians, down from 75 percent in the 1950s.

Price is an alumnus of a boot camp the AMA runs in Washington each winter for physicians contemplating a run for office. Price is one of four members of the caucus who went through the candidate school. In December, the AMA immediately endorsed the Price nomination, a move that led thousands of doctors who feared Price would overturn the health law to sign protest petitions.

Even without Price, Congress will have several GOP physicians in leadership spots in both the House and Senate.

Those include Rep. Phil Roe of Tennessee, the caucus co-chair, who also chairs the House Veterans Affairs Committee, and Burgess, who chairs the House Energy and Commerce subcommittee on health. Sen. Bill Cassidy of Louisiana sits on both the Finance and the Health, Education, Labor and Pension Committees. Sen. John Barrasso of Wyoming chairs the Senate Republican Policy Committee.

Roe acknowledges that his caucus will have newfound influence. Among his goals in molding an ACA replacement are to kill the requirement that most people buy health insurance (known as the individual mandate) as well as to end the obligation that 10 essential benefits, such as maternity and mental health care, must be in each health plan.

He said the caucus will probably not introduce its own bill, but rather evaluate and support other bills. The caucus could be a kingmaker in that role. “If we came out publicly and said we cannot support this bill, it fails,” Roe said.

The GOP Doctors Caucus has played a prominent role in health matters before Congress. For example, in 2015, when former House Speaker John Boehner needed help to permanently repeal a Medicare payment formula that threatened physicians with double-digit annual fee cuts, he turned to the GOP Doctors Caucus. It got behind a system to pay doctors based on performance — the so-called doc fix.

“When the speaker had a unified doctors’ agreement in his coat pocket, he could go to Minority Leader Nancy Pelosi and show that, and that had a lot to do with how we got this passed,” Roe said.

But not all doctors are unified behind the caucus. Rep. Raul Ruiz, one of the two physicians in the House who are Democrats, said he worries because few doctors in Congress are minorities or primary care doctors.

Ruiz, an emergency room physician from California who was elected in 2012, said he is wary about Price leading HHS because he is concerned Price’s policies would increase the number of Americans without insurance.

Indeed, many doctors feel the caucus’ proposals will not reflect their views — or medical wisdom. “My general feeling whenever I see any of their names, is that of contempt,” said Don McCanne of California, a senior fellow and past president of the Physicians for a National Health Program. “The fact that they all signed on to repeal of ACA while supporting policies that would leave so many worse off demonstrated to me that they did not represent the traditional Hippocratic traditions which place the patient first.”

Christina Jewett contributed reporting.

Categories: Syndicate, The Health Law

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