Doctors say the federal travel ban has sown widespread fear. The Medical Colleges Association estimates that about 18,000 current medical residents are not U.S. citizens. Other foreign doctors are practicing on non-immigrant visas.

This article first appeared February 2, 2017 on ProPublica.

By Marshall Allen

Get sick in Toledo, Ohio, and chances are good you'll be treated by a doctor born in another country. If you have allergies, stomach issues or neurological problems, the chances are even better. At least half of those doctors are foreign-born, Ohio Medical Board data shows — some from the seven countries listed on President Trump's travel ban.

Allergist Syed Rehman, for instance, was born in Iraq, attended medical school in Pakistan and came to the United States for his specialty training in 1984. Neurologist Mouhammad Jumaa was born in Syria, went to medical school in Damascus, then did eight years of training in Pittsburgh. And Dr. Imran Ali, a professor of neurology at the University of Toledo Medical School, left Pakistan to complete his training in North Carolina.

For decades, foreign-born doctors like Rehman, Jumaa and Ali have played a vital role in shoring up American's health care system. The doctors come to the United States for residency, drawn by cutting edge medical training and American ideals, then stay to fill the country's growing need for doctors. But Trump's executive order this week — and worries it may expand to other countries, such as Pakistan — has touched off a wave of anxiety, anger and dire predictions that immigrant doctors, faced with hostility or uncertainty, may go somewhere else. The news made the front pages of media outlets across Pakistan and India.

"Overall the thing that attracts people to America is the society, the people, the freedom to pursue your dreams," said Ali, who has raised three kids in Toledo. "If that paradigm changes then what's the reason to come?"

And that, Ali and other physicians said, should worry everyone.

Foreign-born doctors often are willing to work in the isolated rural areas, small towns and blighted urban centers that many American-born doctors shun. It's estimated that about 10,000 foreign-born doctors have served such stints. There are about 926,000 active doctors in the United States, according to the Kaiser Family Foundation. As of 2013, about 45,000 of them came from India, 11,000 from Pakistan and 10,000 from the Philippines, according to data gathered by the American Medical Association. Another 3,800 came from Syria and 3,900 from Iran, which are included in Trump's ban, the data showed.

The need for foreign doctors is likely to grow. A 2016 report by the Association of American Medical Colleges projected a shortage of between 62,000 and 95,000 primary care and specialty physicians over the next decade as the population grows and ages. Monday, the association, which represents medical schools and teaching hospitals, said Trump's 90-day ban on visitors from seven predominantly Muslim countries could cause long-term damage to patients and health care in the United States.

The significant role of foreign-born doctors in many communities can be seen in Toledo, a Rust Belt city of about 285,000 residents. Some foreign-born doctors there estimate that as many as 40 percent of their peers were born outside the U.S., although there's been no official count. Eight of the 14 specialists in the University of Toledo neurology department come from other countries. "I can't even imagine what medicine would look like without foreign-born doctors," said Dr. Gretchen Tietjen, an American-born neurologist who is chair of the department.

Trump's temporary ban is limited to Iran, Iraq, Libya, Somalia, Sudan, Syria and Yemen. It's unknown whether it will be extended or applied to other countries, though such possibilities have been mentioned. Its chaotic implementation caused high-profile examples of doctors being stranded or detained en route to the U.S.

Doctors say the ban has sown widespread fear, even among practitioners from countries it doesn't include. The Medical Colleges Association estimates that about 18,000 current medical residents are not U.S. citizens. Other foreign doctors are practicing on non-immigrant visas. As a result, in Toledo some doctors say colleagues have decided not to go home to Pakistan, or bring loved ones from abroad, because they're afraid of getting caught up in a travel ban. 

The ban could also create bias in the process of matching residents to programs in teaching hospitals throughout the country. The Medical Colleges Association estimates that about 1,000 foreign medical school graduates from the seven banned countries have applied for American residency and fellowship programs this year. Many other applicants could be affected if the ban is expanded to other countries.

On Tuesday, the American Medical Association sent a letter to the Department of Homeland Security voicing concern that residencies may go unfilled and urging it to "provide details and mitigate any negative impact on our nation's health care system," the letter said.

It's resulted in an uncomfortable quandary for Tietjen, who is currently deciding how to rank applicants for four coveted neurology residency positions. Residents are a crucial part of the workforce, she said, helping staff about 1,000 beds at multiple hospitals. Of the 40 applicants who made it to the interview phase, five come from countries under the ban, she said. Now, for the first time, she can't simply judge their skills and potential, she must also look at their nationality and their chances of getting through immigration. Five of the 16 current residents are from Pakistan, and one is from Iran. 

"It just feels morally wrong not to look at people by their qualifications rather than where they came from," she said. "I feel empathy for people who don't get a spot because of this ban."

The White House press office did not respond to an email and phone call.  

In interviews, Toledo doctors from countries such as Syria and Iraq said Trump's ban is likely to discourage others like them from coming to the United States for residency. The physicians are taking a risk and cannot afford to have their time wasted, said Rehman, the allergy specialist, who's affiliated with multiple hospitals in Toledo. "It will hurt us in the near future," he said.

Egyptian radiologist Haitham Elsamaloty came to the United States in 1994 and is the interim chairman of the radiology department at the University of Toledo. He worries his home country may soon be added to Trump's ban and wonders whether others may choose not to follow his path.

"This ban is going to limit students who are very good and have all the drive and motivation to be the scientists of the future," Elsamaloty said. "They will look to Canada. Canada has open arms. Or Germany, France or the U.K. They are all open societies and don't have a ban." 

Jumaa, the stroke specialist from Syria, said the U.S. will always be attractive to foreign doctors because it has the best medical education in the world. But it's a high-risk, once-in-a-lifetime investment to apply for residency in the U.S., he said. Will potential residents from the seven countries still want to come if their families can't visit, or their travel might be restricted?

"I would tell them not to go through the uncertainty and to pursue medical education in another country," he said.

After a task force of experts said evidence didn't support some cancer screenings, it became the target of lawmakers, including Price and others with health industry ties.

This article first appeared February 3, 2017 on ProPublica.

By Marshall Allen

This story was co-published with NPR's Shots blog.

If the last few years are any guide, one group that may find itself in the crosshairs of Rep. Tom Price, President Trump's pick to lead the Department of Health and Human Services, is an influential panel of medical experts.

The U.S. Preventative Services Task Force, a group of mostly physician and academics from top universities, reviews medical practices to see whether they are supported by research and evidence.

Under the Affordable Care Act, the group's recommendations have been used to guide private insurers. If the group gives a test high marks, insurers are required to cover it. If it doesn't, they are free not to.

But letters reviewed by ProPublica show that Price twice pushed HHS to quash the task force's recommendations to limit widely used cancer screenings. The panel said that the screenings too often led to unnecessary biopsies and other harmful treatment.

Democrats on the Senate Finance Committee boycotted a Tuesday vote on Price's nomination, citing unanswered ethics questions.

In 2011, Price and other lawmakers signed a letter asking the head of HHS to "push for the withdrawal" of the panel's draft prostate screening recommendations. The panel was made up of "bureaucrats," the letter said, and decisions about prostate testing were best left to doctors and their patients. "This recommendation jeopardizes the health of countless American men," the letter said.  

The task force went ahead and in 2012 recommended that men of all ages forgo using blood tests to search for prostate cancer. The recommendation didn't apply to men with a history of prostate cancer.

Three years later, Price signed two letters protesting the task force's proposed recommendations that mammograms be given every two years for healthy and risk-free women between the ages of 50 and 74, and by individual choice for women between 40 and 49. Other groups, including the American College of Radiology, recommend starting mammograms at 40 and having them every year or two.

In May 2015, Price and other lawmakers wrote that the task force recommendations "would jeopardize access to screenings." In June, a second letter signed by Price and others with the GOP Doctors Caucus, went further, urging the head of HHS to ensure the recommendations weren't finalized. The recommendations, the letter said, could "result in thousands of additional breast cancer deaths."  

Despite the complaints, the mammogram recommendations were issued in 2016. Proponents praised them as the fruit of the task force's independent and evidence-based approach. But the guidelines raised the ire of a much more powerful constituency: the urologists and radiologists who made billions of dollars off the testing and related procedures.

The dirty underbelly of screening is that it's a great way to get more patients," said Dr. Gilbert Welch, professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice and a close observer of the task force's work. "The financial underpinnings are huge."

The health-care industry spends more money lobbying Congress than almost any other sector, according to the tracking site OpenSecrets.org. Price, an orthopedic surgeon, took in $479,000 in health professional donations in the 2016 campaign cycle, one of the largest sums to any member of Congress.

To be sure, the industry has a host of more pressing concerns, from the ACA and Medicare and Medicaid to the cost of drugs. But the task force's recommendations have continued to draw complaints by lawmakers who received financial support from the industry.

In November, lawmakers bashed its screening recommendations during a hearing of the health subcommittee of the House Committee on Energy and Commerce. The task force "can deprive patients of lifesaving services," said Rep. Michael Burgess, a Republican from Texas who received nearly $611,000 from health professionals in the 2016 campaign cycle. 

His colleague, Rep. Marsha Blackburn, a Tennessee Republican who received $259,000 in donations from health professionals in the 2016 campaign cycle, predicted equally dire outcomes. The task force, she said, "turned its back on over 20 million women by finalizing erroneous guidelines that would limit access to mammograms."

Earlier this month, Blackburn re-introduced legislation that would, among other things, add specialists to the panel. The group currently consults with specialists in the areas they are reviewing. Critics of the proposed bill say specialists are not ideal to perform the task force's broad array of evidence reviews, and adding them could create conflicts of interest. "There is considerable support for 'draining the swamp' in Washington," Welch wrote in testimony he submitted for the hearing. "But there is no swamp currently in the task force. Please don't create one."

Questions sent to Price's office were answered by Ryan Murphy, who is currently an HHS adviser. Murphy was most recently communications director for the House Budget Committee, of which Price is chairman.

"Dr. Price's concerns — shared by others as you noted — were with specific recommendations made by the task force," Murphy said. "As a physician, Dr. Price knows firsthand the value of scientific research as well as how important it is to ensure patients and their doctors are able to make choices regarding treatments that they agree are in the best interest of the individual patient."

Price has embraced task force findings that recommend more treatment. In 2014, for example, he co-signed a letter to the HHS secretary and the Medicare administrator asking that Medicare expand its coverage for lung cancer screenings for smokers based on task force recommendations.

With the shifts in power both in Congress and under the Trump administration, proponents of the task force fear setbacks in the decades-long push for evidence-based medicine. The task force has 96 current recommendations, which it routinely updates. Its $11.6 million budget is funded through HHS's Agency for Healthcare Research and Quality, which has been on the lawmakers' chopping block in the past. If confirmed, Price or congressional Republicans could reduce the task force's influence or independence, or cut its funding.

"Science is really under attack," said Fran Visco, president of the National Breast Cancer Coalition. "We've spent decades building a scientific and research infrastructure and community all in order to produce the evidence that will save lives. Sometimes the science doesn't give us the answer we would like, but it actually gives us the facts and the evidence."

While some disagree with the task force's recommendations, its work is in line with a global push toward evidence-based medicine and with the guidelines of some other groups. The International Agency for Research on Cancer says there isn't enough evidence to recommend for or against mammograms for women between 40 and 49. Like the task force, the American College of Physicians says mammograms should be an individual decision for women between the ages of 40 and 49 and be provided every other year at the patient's request.

The task force and others found widespread screening often led to false positives, painful biopsies and life-altering operations for patients who were not actually at risk of cancer. Unnecessary screening also contributes to an overtreatment epidemic that the Institute of Medicine has estimated costs $210 billion a year.

Dr. Kirsten Bibbins-Domingo, chairwoman of the task force, is a internist and epidemiologist at the University of California, San Francisco. She said the attacks by Blackburn and others risk misleading patients about the effectiveness of screening for patients who are not at risk and are free of symptoms. "Patients and clinicians need to understand the benefits and the harms so they are empowered to make the best decisions for themselves," Bibbins-Domingo said. 

Regardless of what happens politically, she said, patients and doctors will still need evidence-based recommendations to make informed decisions.

The evidence-based work of the task force could be "endangered" because the panel is caught up in the political fight around the ACA, said Dr. Sheldon Greenfield executive co-director of the Health Policy Research Institute at the University of California, Irvine. "It wouldn't surprise me if it does become a casualty."

The worst outcome, he said, would be for health care in the United States to revert to the way it used to be. The old joke is that doctors ignore science and say, "I know best," Greenfield said, trumping evidence-based medicine with "eminence-based" medicine. 

Marshall Allen is examining how waste and overtreatment are affecting patients and raising the cost of care. If you have evidence of wasted health-care dollars, please email him at marshall.allen@propublica.org.

Penalties against companies that serve as middlemen between drug companies and pharmacies have been relatively scarce—until recently.

This article first appeared January 27, 2017 on Kaiser Health News.

By Charles Ornstein

This story was co-published with NPR's Shots blog.

As the toll of the opioid epidemic grows, scores of doctors have lost their licenses and some have gone to prison. Pharmacies are being sued and shuttered. Pharmaceutical manufacturers are under investigation and face new rules from regulators.

But penalties against companies that serve as middlemen between drug companies and pharmacies have been relatively scarce — until recently.

In the past month, two major drug distributors, also known as wholesalers, have formally agreed to pay millions of dollars to settle claims that they failed to report suspicious orders for controlled substances to the Drug Enforcement Administration, as required by law.

McKesson Corp., the largest such company in the U.S., last week agreed to pay a $150 million fine. And late last month, Cardinal Health reached a $44 million settlement with the federal government. That's on top of another $20 million that Cardinal Health agreed this month to pay the state of West Virginia, which has been among the hardest hit by opioid overdoses. Other distributors have also agreed to pay smaller amounts to West Virginia within the past few months. AmerisourceBergen, for instance, will pay $16 million.

"Have the distributors gotten the message? I would hope so," said Frank Younker, who worked at the DEA for 30 years and retired as a supervisor in its Cincinnati field office in 2014. "The distributors are important. They're like the quarterback. They distribute the ball. … There's plenty of blame to go around."

The death toll from drug overdoses topped 52,000 in 2015, including 33,000 involving an opioid, according to the Centers for Disease Control and Prevention. Although the epidemic began with prescription pills, it is now being driven largely by heroin and various synthetic opioids.

The fines, some of which had been in the works for years, come as news organizations have raised questions about the significant role distributors have played by failing to stop or report pharmacies that appeared to be dispensing more pills than seemed reasonable.

The Charleston Gazette-Mail reported in December how drug companies shipped nearly 9 million hydrocodone pills over two years to one pharmacy in the town of Kermit, West Virginia, population 392. All told, the newspaper reported, drug wholesalers distributed 780 million pills of oxycodone and hydrocodone in the state over six years. "The unfettered shipments amount to 433 pain pills for every man, woman and child in West Virginia," the story said.

The Washington Post reported in October how DEA leadership delayed and blocked enforcement actions as the overdose epidemic grew. Civil case filings against distributors, manufacturers, pharmacies and doctors dropped from 131 in fiscal 2011 to 40 in fiscal 2014, the Post reported. Immediate suspension orders (the toughest sanction the DEA has) fell from 65 to 9.

Later, the Post reported why that may have been: The drug industry had hired dozens of officials from the DEA, leading some current and former officials to ask whether the industry sought to hire away those who presented "the biggest headaches for them."

Reports also have suggested that the DEA's ability to go after problem distributors has been hobbled by watered down enforcement powers. The Los Angeles Times reported in July how Congress passed a bill supported by industry that allows companies accused of failing to report suspicious orders to delay enforcement proceedings against them if they submit a "corrective action plan." It also made it harder for the agency to immediately suspend the licenses of those it oversees. President Barack Obama signed it into law in April 2016. Critics say it removed key tools at the DEA's disposal.

In response to written questions for this story, the DEA said it has always held distributors "accountable for preventing the diversion of controlled and abused prescription drugs, including the opioid painkillers."

Asked if its recent fines were too little, too late, the agency replied, "We don't think so. We hope large fines such as this one [against McKesson] will get the attention of the companies' leaders and stockholders and prompt them to be responsible corporate citizens, because people are dying as a result of the diversion of the opioid drugs they sell, and that can't continue."

In statements released when the distributors finalized their settlements, the companies said they have improved their performance in recent years. McKesson noted that the settlement covers reporting practices dating back to 2009. "Since 2013, McKesson has implemented significant changes to its monitoring and reporting processes," the company said in a statement.

As part of the settlement, the DEA will suspend the registrations of four of McKesson's distribution centers, on a staggered basis, blunting the effect of the punishment.

"Pharmaceutical distributors play an important role in identifying and combating prescription drug diversion and abuse," John H. Hammergren, chairman and chief executive officer, said in the statement. "McKesson, as one of the nation's largest distributors, takes our role seriously."

The DEA had previously taken action against McKesson in 2008 for failing to report suspicious orders, a factor cited in the latest fine.

Cardinal Health's fine was the last aspect of a 2012 settlement with the DEA, which included a two-year suspension of its Lakeland, Florida, distribution center. "These agreements allow us to move forward and continue to focus on working with all participants in addressing the epidemic of prescription drug abuse," Craig Morford, its chief legal and compliance officer, said in a statement last month.

Federal prosecutors who worked on the McKesson case said that distributors play an important role in the overall system in which controlled substances get distributed. "What Congress envisioned is that there would be gatekeepers along the way in this closed system," said Kurt Didier, an assistant U.S. attorney in Sacramento, in an interview. "It starts with the physician writing the prescription and the pharmacist filling the prescription. In between, you have entities like the distributors.

"In this overall scheme, a distributor is obligated to report to DEA prescriptions or orders that it views are suspicious," Didier said.

The agencies regulating the industry have had their own problems. The Gazette-Mail reported that the West Virginia pharmacy board didn't pay much attention to its own rules requiring that wholesalers report such orders. The board also had not examined reports from distributors regarding suspicious orders by pharmacies, nor had it shared those with law enforcement.

For its part, the DEA also has been faulted several times by the Government Accountability Office for, among other things, how it sets annual quotas for the amount of controlled substances that can be produced, the information and guidance it provides to the entities it regulates, and how it uses confidential informants.

The Healthcare Distribution Management Association, the trade group that represents the distributors, asked the DEA in 2010, 2011 and 2013 to clarify the companies' roles and responsibilities, but it received no response.

Younker said he's worried that the law Congress passed last year, allowing distributors to sign corrective action plans instead of being sanctioned, could hamstring the DEA. "That's a very big blow. ... Will you again see these large-scale fines? I personally doubt it."

In its responses to ProPublica, the DEA said that it worked extensively with Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I., to develop the new law. "That law doesn't change our role as regulators but it does impact the tools that we have to take action against distributors who aren't meeting their responsibilities to prevent diversion."

Chuck Rosenberg, the DEA's acting administrator, told a Senate panel last year that his agency was working to improve itself and its interactions with those it regulates. "In many ways, I think we're broken...," he said. "I think we've been slow. I think we've been opaque. I think we haven't responded to them."

Jim Geldhof, who retired in January 2016 after more than 40 years with the DEA, most recently as a manager in the Detroit field office, said the recent fines are important, but he wonders if they will make any difference. "It's going to be pretty hard to undo the damage that's been done," said Geldhof. "Do they get it? I don't know. I don't have a real lot of faith in industry frankly."

Critics maintain that the 21st Century Cures bill, which passed the House Wednesday, hasn't received the scrutiny that such sweeping legislation deserves.

This article first appeared November 30, 2016 on ProPublica.

By Alec MacGillis

Update, Nov. 30, 2016: This week, Congress is taking back up a sweeping bill introduced last year that would expand medical research funding while also loosening the regulations for approving new drugs and medical devices. While the legislation has undergone revisions, it still includes many of the deregulatory provisions that have drawn criticism from some consumer safety advocates. Back in October 2015, we detailed the bill's origins and the massive lobbying push by the drug and device industry supporting it.

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This might seem to be a rough political patch for the pharmaceutical and medical device industries. The exponential price increases of several drugs have brought scrutiny to the overall rise in drug costs and have prompted several 2016 candidates, most notably Hillary Clinton, to vow action to rein in the industry. Meanwhile, thousands of complaints are pouring into the Food and Drug Administration about a contraceptive implant made by Bayer.

In Congress, however, things are looking better for the manufacturers. Legislation is advancing that would speed up the FDA's approval process for medications and medical devices, offering a rare example of how major initiatives can get traction even in today's gridlocked Washington.

The industry has mounted a major lobbying and public relations push for the 21st Century Cures Act. The bill, in turn, has garnered an unusually broad range of support, ranging from Republican lawmakers and conservative think tanks to the White House, patient advocacy groups, Democrats and nonprofit organizations that are typically leery of deregulatory efforts by industry. One reason: Lawmakers softened up the usual opponents of looser rules with a big carrot — billions of dollars in new federal medical research funding for the National Institutes of Health. After years of austerity, that money is awfully difficult to turn down.

But the enthusiasts have left a small band of critics warning that bipartisan consensus does not necessarily affirm the bill's worth. Far from showing that Washington can still get big things done, they say, it shows how a lobby can blow past skeptics if the pot of resources is sweet enough. They maintain that the bill, which easily passed the House in July and has a counterpart soon to be introduced in the Senate, hasn't received the scrutiny that such sweeping legislation deserves.

"Expanding NIH funding in a substantive amount is a grand and wonderful thing," said Susan Wood, a former assistant FDA commissioner for women's health who is now a professor at George Washington University. "But the price of that expansion should not be the gutting of the FDA."

Wood's criticism is echoed by other former FDA officials including David Kessler, who was appointed commissioner by President George H.W. Bush, as well as by two Harvard medical school professors who argued in a leading journal that the bill "could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit."

For their part, the bill's proponents say it would spur innovation, particularly when it comes to finding cures for rare diseases — of the 10,000 or so known diseases, 7,000 are considered rare and treatments exist for only 500. Francis Collins, director of the NIH and a leading champion of the bill, says it now takes "around 14 years and $2 billion or more" to develop a new drug and notes that all but five percent of drugs fail during development.

If the legislation passes the Senate and is signed by President Obama, the FDA would be encouraged to develop faster routes to the approval of new products. Under the current system, most new drugs and devices must pass through multiple levels of clinical trials that can take years to conclude. One alternative would be to make more frequent use of so-called "biomarkers" that gauge physical responses to a drug rather than waiting for the final results from a patient trial.

To increase the incentive for drug makers to seek cures for rare diseases, the bill also would grant an extra period of exclusive marketing rights to a company if an existing drug were approved to treat a rare disease after having been previously approved for a different disease.

"The 21st Century Cures legislation is viewed very positively by both political parties and the public at large," said Michael Castle, a former House Republican from Delaware who is the vice chairman of Research America, an organization that lobbies for biomedical research funding. "If you get down to a list of substantive legislation that has actually a chance of passage now, something like 21st Century Cures is very high on that list."

The legislation is responding, in part, to the demand from many patients' groups for medical breakthroughs. "It doesn't mean you give the industry free rein, but are you really protecting the public if you're preventing real cures from getting to them?" said Brian Baird, a former Democratic congressman from Washington state who supports the bill.

The bill's critics have argued that the FDA has already greatly streamlined its approval processes. A recent analysis by Forbes found that so far this year the FDA has rejected only three never-before marketed drugs, and approved 25, an approval rate of 89 percent, up from 66 percent just seven years ago. "We're the fastest regulatory agency in the world," said Gregg Gonsalves, a prominent HIV activist now working as a research scholar at Yale Law School. "Pharma would just be very pleased to do less work for more gain."

Stephen Ostroff, now the FDA's interim commissioner, has said the agency initially had concerns about the House bill, but that officials were reassured by revisions. The version that passed would only encourage the agency to use the alternate approval methods, rather than require them. Still, critics note that the FDA would get only $550 million to administer the new approval processes, far less than it says it needs to do so properly.

The legislation has its roots in a longstanding push by conservative groups to liberate drug and device development from red tape. "Now, I don't want to get your hopes up, but Phase Three, maybe we'll take out FDA," said Newt Gingrich during the Republican Revolution of 1994, when he also called the agency the nation's "leading job killer." More recently, the deregulatory crusade against the FDA has been led by conservative think tanks such as the Goldwater Institute and Manhattan Institute, which launched its "Project FDA" to reform the agency so that it provides a "more predictable, transparent, and efficient pathway" for new medications and devices.

The cause was taken up in Congress over the last couple years by House Energy and Commerce Committee Chairman Fred Upton, a Michigan Republican who will be giving up his gavel to term limits next year and is, his colleagues say, eager for a major legislative capstone before he leaves. Upton has received major backing from the drug and device industries—in the last election cycle, they contributed about $370,000 to him and his associated political action committee, according to the Center for Responsive Politics, more than all but two other business sectors.

Besides campaign contributions, the industry has invested in lobbying. The Pharmaceutical Research and Manufacturing Association, which represents drug makers, increased its quarterly lobbying from $3.96 million to $5.44 million as Upton prepared to release the legislation early this year. The Advanced Medical Technology Association, which represents device makers, increased its quarterly lobbying spending from $550,000 to $740,000 in the same period. Drug and device makers themselves also increased their lobbying expenditures, the records show.

But the key for the legislation's proponents has been to earn support beyond Republicans and the industry. Early on, Upton enlisted help in crafting the bill from Rep. Diana DeGette, a Colorado Democrat, for whom the legislation was a chance to make a mark on the Energy and Commerce committee, and Rep. Gene Green, a Texas Democrat whose physician daughter took great interest in aspects of the bill.

Then many other Democrats, including New Jersey's Frank Pallone, the ranking member on Energy and Commerce, lined up behind the legislation when Republicans in June added nearly $9 billion in new support for the NIH over the next five years. The agency has seen its funding essentially flat-line for more than a decade at about $30 billion per year. Pallone did manage to scale back many of the "marketing exclusivity" provisions.

The NIH money also brought the bill support from patient advocacy organizations, from the American Cancer Society to smaller groups seeking cures for rare diseases, which the bill's proponents say would benefit particularly from the deregulatory reforms.

"I don't see this as a pro-industry bill," said Ellen Sigal, the founder and chairwoman of the Friends of Cancer Research. "It's a bill for innovation and research at basic levels." She added: "It's hard, frankly, not to support it. There are very few people who are not supporting it."

The promised NIH money also brought on board major universities, which carry out about $15 billion of all NIH-funded research. "It was the investment in NIH that led everyone to get behind it," said Atul Grover, chief public policy officer at the Association of American Medical Colleges. "As soon as we talked about innovation, people said, look, you can try to grease the skids on the approval process, but if we're not investing as a nation in research, then this other stuff is not going to make much difference. You have to invest in cures to get them."

The list of entities lobbying on the bill now runs to about 1,800 quarterly entries in the Senate's lobbying database, with more than 1,100 lobbyists registered as working on it, which is staggering even by the standards of Washington. And what has been so beneficial for the legislation is that the vast majority of those entities are not companies or trade associations, which are motivated by bottom-line demands, but patient groups and universities, which have a far more neutral sheen.

"Members of Congress who wouldn't be responsive to pharma's lobbying did respond to universities' lobbying or to patients' lobbying," said Diana Zuckerman, president of the National Center for Health Research, an advocacy group that has spoken out against the legislation. "It was a perfect storm of lobbying."

In fact, there is considerable overlap between the sets of advocates. Drug and device makers have long provided financial support to many patient and disease groups—some of the money that those groups are spending in pushing for the legislation is also coming from industry coffers. Similarly, many academic researchers whose institutions are lobbying for the legislation in Washington have received consulting and speaking fees from the industry.

The lobbying has also gotten a big boost from Michael Milken, the former junk-bond king who took up the cause of medical research after surviving prostate cancer. Milken has been hosting events in Lake Tahoe, New York, and elsewhere to bring members of Congress together with researchers, patient advocates and industry executives who support the bill.

Meanwhile, an array of the bill's promoters, including industry representatives, patient groups and scientific associations, are monitoring the legislation's progress in weekly conference calls and monthly meetings at the office of the American Association of Medical Colleges, regular contacts that the association says it has been hosting for years to push for funding.

The overlap was on display recently at the annual luncheon for one of the nonprofit groups backing the bill, Research America. At the Newseum in Washington, dozens of industry officials, patient advocates and academic researchers mingled with the event's sponsors, which included the drug companies Astellas, Shire, Janssen, Celgene and Gilead, as well as AdvaMed, the device lobby. Various panel discussions ranged widely across the challenges facing medical research, but throughout the event there was a steady drumbeat urging those in attendance to keep pushing Congress to pass 21st Century Cures.

"We want them to hear us in the Capitol," said Research America director Mary Woolley as she kicked off the event. "Decisions made just a few blocks from here this fall will be consequential." (Research America itself receives support from the industry to help cover its costs, which includes Woolley's roughly $500,000 in annual compensation.)

She was followed by Jeffrey Bloss, Astellas' senior vice president for medical affairs, who hailed the "groundswell of support" and "massive effort" for the bill. "We need to count on your impassioned advocacy for these changes," he said.

In an interview afterward, Woolley hailed the coalition behind the legislation. "It's a very broad consensus—as broad as you can have," she said. "It's patient groups, it's physicians, it's industry, it's the academic community, it's everybody. It's a goal America can embrace. This is legislation that can make everybody look good."

And she dismissed the notion that concerns about the bill's impact on drug safety were being cast aside. "Industry are people too, and they're patients too," she said. "The idea that industry is just in this to peddle toxic drugs to sick people is absurd." She added, "You'd have to think that people from industry and their families are exempt from disease. It's preposterous. Mistakes hurt everybody."

Also buttressing the coalition are experts and organizations that in the past have sometimes cautioned against FDA deregulation. One of the bill's strongest early proponents was the Bipartisan Policy Center, which in January announced a one-year initiative to overhaul the FDA led by former Senate majority leader Bill Frist, the Tennessee Republican and physician.

The bill has also gotten vocal backing from the center-left Brookings Institution, whose director of health care policy, Mark McClellan, served as FDA commissioner under George W. Bush. "None of [the bill's reforms] is replacing or modifying the FDA's standards that it needs to be confident that a drug is safe before approval," he said. "It's just modifying the evidence that can be brought to bear in making that decision." McClellan said his support for the bill had zero connection to the funding Brookings receives from drug and device companies, which includes between $500,000 and $999,000 from Genentech and between $100,000 and $249,000 from Amgen. "Those are gifts to the overall institution and they are a small fraction of support to the institution," he said.

The bill has even gotten support from Pew Charitable Trusts, which has in the past taken the lead in advocating for drug safety. More recently, though, it has taken up the cause of developing antibiotics to combat dangerous infections, and the legislation includes language to speed the development of new antibiotics. Allan Coukell, Pew's director of health programs, says the organization has endorsed only that portion of the bill, along with a section on prescription painkiller abuse. "I have to limit myself to talking about the provisions we're working on," he said. But in promoting those sections of the bill, Pew has also not issued public criticisms of other sections of the bill, to the dismay of some of its usual allies.

"The most difficult thing for the consumer-protection groups has been seeing these seemingly nonpartisan groups sweeping in and embracing the bill as if it's good for science when everything shows it has the opposite effect," said Vijay Das, a health care advocate with the watchdog group Public Citizen.

The legislation passed the House by a lopsided 344-77 vote in July. All eyes are now on Lamar Alexander, the Tennessee Republican who chairs the Senate Health, Education, Labor and Pensions Committee, which is expected to release its own version of the bill soon. Alexander has also spoken out for the need to speed up drug approvals—he co-authored a Bipartisan Policy Center report calling for an FDA overhaul—which leaves it likely that the deregulatory language in the Senate version will mirror that in the House. What remains to be seen is whether the Senate will match the House in mandating additional billions for the NIH, an approach that would break from the Senate's traditional appropriations process.

Meanwhile, the White House has also expressed support for the legislation, while suggesting some changes, lauding it as a rare example of bipartisan action and a breakthrough against GOP-led budget austerity.

But David Ross, a former deputy director of drug evaluation at the FDA who now oversees HIV, hepatitis and public health pathogen treatment for the Veterans Administration, still questioned the bill's underlying justification — that it would result in a higher number of effective drugs getting to market much faster.

"We definitely need more effective drugs, but just calling something effective doesn't make it so," Ross said. "It's a little like gluing some feathers together and calling it a duck. Most drugs that go into studies don't make it not because the FDA is too strict, but because they don't just work."