Stories written by Jo Ciavaglia, award-winning multimedia newspaper reporter at the Bucks County Courier Times in Bucks County, a suburb of Philadelphia, Pa.
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A charity connected with a suspended Lower Southampton deputy constable and a former Lower Southampton public safety director who were indicted on money laundering charges has been ordered to stop accepting donations after the state determined that it was improperly registered.
The order issued on Aug. 30 bars the H.O.P.E. for Single Parents and Families -- an organization that lists Bernard Rafferty, 62,the suspended deputy constable from Lower Southampton, as a co-founder -- from soliciting contributions in the state until it provides the Bureau of Corporations and Charitable Organizations with “all previously requested information and duly registers” or provides proof that it is exempt from registration because its income is less than $25,000 a year.
The order did not state what information was previously requested.
Department of State spokeswoman Wanda Murren declined to comment further on either H.O.P.E. or another Rafferty-founded charity, Your Giving Hands, which merged with H.O.P.E. in 2012. She said the charities may not have to register if they provide proof that they meet certain criteria for exemption, but that department officials had not received this proof by Aug. 30, when they issued the cease-and-desist order. The order is still in place as of Monday afternoon, Murren confirmed.
The cease and desist order was mailed to Tullytown and Feasterville addresses associated with co-founder, CEO and President Kelly Harold. The nonprofit’s website lists the former Doylestown Township law office of Robert Hoopes, the former Lower Southampton public safety director, as its headquarters and the location where donations could be mailed or dropped off.
H.O.P.E.-Your Giving Hands, as it is identified in the order, was one of 14 organizations the state charities bureau took action against in August, according to a news release. It is one of three organizations that receiveda cease and desist order and could face civil fines and fees if it continues fundraising.
Bernard Rafferty and HOPE co=founder Kelly Harold
Murren added that before the state issues a cease and desist order it would attempt to assist an unregistered organization to bring it into compliance with the registration law.
Hoopes, Rafferty and then-Lower Southampton District Judge John Waltman were indicted in December 2016 on federal charges of conspiracy and money laundering. The trial for the men is scheduled to take place this month in U.S. District Court. This news organization was unsuccessful in reaching Hoopes; Hoopes’ attorney, Megan Scheib; Rafferty; or Rafferty’s attorney, Brian Puricelli for comment.
The cease and desist order was issued three months after this news organization published an investigation into the charities following the arrests. The investigation found that neither organization or the merged charity has been designated as afederally recognized nonprofit, which allows donors to make tax-deductible donations and frees organizations from paying state and federal taxes on any money collected or anything they buy, nor have theyfiled state or federal financial disclosure documents showing how much money was collected and distributed annually.
But the charities did collect money. Your Giving Hands received at least one $500 donation and H.O.P.E. received at least $1,500 in donations -- including $1,100 in “community grants” from the Feasterville Business Association -- in 2012 and 2013, according to H.O.P.E.’s website, Lower Southampton supervisor meeting minutes and interviews with donors and others familiar with the organization.
The findings brought the charities to the attention of Bucks County Consumer Protection Director Michael Bannon, who filed a complaint with the state Bureau of Corporations and Charitable Organizations. Bannon said last week that he was pleased the state looked into the groups’ practices and took action.
In response to Facebook messages sent Thursday and Friday seeking comment, Harold said she filed forms with the state confirming the nonprofit had not been active since August 2013.
Harold has described H.O.P.E. as a transitional housing program for middle and working-class families, but said it “never received any donations.” A planned 2013 fundraiser to raffle off a car was canceled and the money collected returned to ticket-buyers, she said.
“We were not active long at all,” she said.
Harold also said that she has not spoken to Rafferty in years and his involvement with the nonprofit took place “way before he got into any trouble.”
Rafferty was named executive vice president of H.O.P.E.in July 2012, according to the H.O.P.E. website. Previously, Harold said that Rafferty became part of the organization because he had “connections.”
Before he joined H.O.P.E., Rafferty registered Your Giving Hands as a nonprofit corporation with the Pennsylvania Department of State on Dec. 31, 2009; the nonprofit is still listed as active, according to the state agency’s website. Its headquarters is listed as a Lower Southampton gas station, according to copies of the filing documents.
Your Giving Hands had a website that was active in September 2011, according to the internet archive the Way Back Machine. It described nonprofit as providing a “helping hand to people in need within our community,” and listed Rafferty as its contact.
It is unknown exactly how much either charity raised since neither filed financial disclosure statements required by the Internal Revenue Service for charities. At least nine events billed as fundraisers to benefit H.O.P.E. were held in 2012 and 2013 and multiple Facebook posts -- before the page was removed -- also solicited client applications and business affiliates and sponsors for its program through 2014.
The former treasurer for H.O.P.E., Tim Doyle, declined to answer questions, saying he had not been with the organization “for years.”
A lawyer representing a New Jersey man in a federal class action suit against Bucks County and its prison believes a mugshot could be worth nearly $700 million.
A U.S. District Court judge gets the final say on whether Daryoush Taha, 46, of Sicklerville, and possibly others, are awarded as little as $1,000 or as much as $680 million in what one Temple University law professor called a precedent-setting class action suit.
“It’s a very novel case,” said attorney Jonathan Shub, who is representing Taha, the lead plaintiff in the suit. “This statute has never been tested.”
Taha sued the county four years ago, alleging it violated his civil rights when it included on its online inmate lookup tool his mugshot and other information from a 1998 arrest in Bensalem on charges of harassment, disorderly conduct and resisting arrest.
Taha was accepted into a one-year trial diversion probation program for non-violent first offenders, which he completed, and his arrest information was ordered expunged in January 2000.
Bucks County created its electronic inmate lookup search tool in January 2011 and later that year, Taha claims he learned his arrest information and mugshot were still listed on the site, according to the suit. The county removed all inmate mugshots and most arrest information from the website in June 2013, as a result of Taha’s lawsuit.
Last year a U.S. District Court judge found that the county violated the Pennsylvania Criminal History Record Information Act, known as CHRIA, when it disseminated Taha’s arrest information and mug shot. The law prohibits the dissemination of a person’s criminal history record to anyone outside law enforcement when the person hadn’t been convicted of the crime.
The judge also granted Taha’s motion to certify his case as a class action suit, which opened the possibility of 68,000 class members -- other individuals whose criminal history record information was made available on the county prison’s inmate look up tool before it was revamped, Shub said.
The county appealed the class action certification to the Third Circuit Court, which in August issued a decision upholding the class action status. As a class action suit, any punitive damage award would be divided among all the members of the class action and its attorneys.
Philadelphia attorney Burt Rublin, who is representing the county, declined to comment, saying county officials did not authorize him to speak about the case.
If the court decides the county “willfully” violated the statute, the punitive award is $1,000 to $10,000 per violation, under the law.
“We think we can prove willfulness and each posting of another name is a willful violation,” Shub added. “Bucks County faces a serious predicament.”
But Ken Jacobsen, a Temple University law professor, has doubts. He has specialized in class action suits for 30 years.
While the court found Bucks County violated CHRIA -- which entitles Taha and the class members to punitive damages -- it did not award Taha actual damages because he did not contend that he suffered any economic losses as a result of his arrest information being posted online. If the case goes to trial, it’s possible a jury could find Taha isn’t entitled to punitive damages, which are typically seen as a secondary punishment to deter egregious conduct, Jacobsen said.
Another crucial factor will be how the court defines willful conduct, Jacobsen said: Is it simply the act of putting the arrest information online, or does there need to be evidence the county intended to humiliate and harm individuals when it put the information online?
Even if the court determines the county willfully violated the law, the bigger unknown is what the court determines is a violation.
Bucks County contends in court documents the posting of the 68,000 individuals constitutes a single violation, meaning the damage award would be between $1,000 and $10,000. Shub believes each individual posting is a violation, upping the potential damage award to $68 million to $680 million.
But since Taha couldn’t prove he suffered actual damages, it’s less likely that other members of the class can prove damages, too, Jacobsen said.
“Unless there is some statutory minimum without proof of harm, it’s going to be interesting to see how damages are proved for these 60,000 other people,” Jacobsen said. “It’s an interesting case.”
After Richard Griffin stole an SUV that was left idling in the parking lot of a Bristol Township convenience store, he quickly learned an 11-year-old passenger was in the backseat.
Once the boy made his presence known, Griffin pulled over and let him out before driving away, according to court records in the 2009 crime.
The boy wasn’t hurt. Griffin was arrested and later pleaded guilty in Bucks County Court to charges including theft, receiving stolen property and interference with custody of children.
The custody offense is the only reason the Philadelphia man is a registered sex offender in Pennsylvania.
Sen. Stewart Greenleaf, R-12, of Upper Moreland -- who led the Senate effort to adopt Megan’s Law in 1996 -- believes offenders like Griffin don’t belong on the state’s sex offender registry.
The lawmaker has introduced legislation that would remove interference with custody of children as an offense requiring sex offender registration under the state’s Megan’s Law, which carries repercussions including loss of personal freedom and loss of privacy. It can also lead to a person being socially ostracized.
“I thought that was the most logical thing to do. The most clear thing to do,” Greenleaf said Wednesday. “I want to make sure no one ever has that quandary to deal with again.”
Greenleaf previously cited this news organization’s July 23 investigation, which found at least 34 Pennsylvania residents with no known record of sexual crimes are listed as sex offenders on the state’s Megan’s Law registry as the catalyst for his proposed legislation. Those offenders account for at least 75 percent of those on the registry for interference with custody of children, a felony that carries an automatic 15-year registration obligation in the state.
At least one-quarter of those 34 registered sex offenders with no sex crime record are noncustodial parents convicted of violating a court order or otherwise improperly taking their own children, according to this news organization’s investigation. Other offenders were convicted of interference with child custody for crimes such as stealing a car with a child passenger, like Griffin, 36, who declined comment when reached recently.
Senate Bill 854, which was referred to the Senate Judiciary Committee Greenleaf chairs, would correct an “unintended consequence” of the state’s 2011 update of the sex offender registration law that added interference with custody of children to the list of offenses requiring registration; the only other state where a custody crime conviction requires registration is Louisiana, but its law exempts the parents of a victim child.
Pennsylvania’s law, which took effect in December 2012, has no parental exemption, though one was included in the original state Senate version of the bill adopting the federal Adam Walsh Act, according to Greenleaf and Senate records. But the bill underwent extensive changes in the House and the exemption was removed from the version that received unanimous approval in the House and Senate.
Steve Miskin, a spokesman for the House Judiciary Committee, which removed the original Senate parent exemption, previously indicated that it also plans to review “a number of topics” under Megan’s law including interference with custody of children. This news organization was unsuccessful in reaching Miskin Wednesday for comment.
Removing interference with custody of children from the list requiring sex offender registration is a good first step, said Aaron Marcus, an attorney with the Defenders Association of Philadelphia who has handled at least a dozen cases involving people forced to register as sex offenders for custody crime convictions.
“I am pleased to see the Senate remove this offense, which has caused a large number of people irreparable harm, but this legislation is not a solution,” Marcus said. “I believe much more action is needed to address the outrageous conditions imposed upon thousands of Pennsylvanians who have served their sentence and pose no continuing danger to the community.”
It remains unclear how the bill, if it were signed into law, would impact individuals currently on the registry for custody crimes. Generally criminal laws do not operate retroactively, according to Patrick Crawley, counsel to the Senate Judiciary Committee, which helped draft the bill.
“But as a constitutional matter, the courts may see this as something that must work retroactively,” he said.
Marcus, of the Defenders Association, added the law could be applied to offenders on the registry since interference with custody would no longer be considered a “sexually violent offense” under the law. “Basically, I think the legislation would apply retroactively and those who are registering for interference should be removed,” he added.
Lehigh County resident Shaquana Green, 26, who has been on the sex offender registry for four years after pleading guilty in 2013 to interference with custody of children, was stunned to learn Wednesday that legislation had been introduced that would remove her crime from the registry.
Green, whose story was featured in the July 23 story published by this news organization, disappeared with her then-toddler-age daughter during a scheduled weekly supervised visit. Green is a noncustodial parent. Her daughter’s paternal grandmother is the legal guardian. The daughter was returned unharmed fewer than three hours later and court records in the case mention no allegations of sexual contact.
Green, a single mom who now has a nearly 2-year-old son, recounted the hardships she has encountered as a registered sex offender, including rejections from potential landlords and employers, as well as social service programs involving children.
Since her story went public, she continues to encounter difficulties. She recently was turned down for two jobs because, she said, her potential employer was wary of her sex offender status.
“This is amazing. This is a blessing,” Green said Wednesday. “I’m just at a loss for words right now.”
Just under 2,100 Pennsylvania newborns whose mothers had Medicaid were diagnosed with narcotics withdrawal syndrome last year, but only 972 infants were reported to county child welfare authorities as having been exposed to drugs in the womb.
In 2015, the first year the state broke out data for those substance-exposed newborns, 707 infants were reported to child welfare as being exposed to narcotics, but 2,350 babies were diagnosed with withdrawal from narcotics, known as neonatal abstinence syndrome, according to the statistics from the state Department of Human Services.
Yet no gap should exist between the number of babies diagnosed and those reported to child welfare agencies, since all cases of infants who were exposed to legal or illegal narcotics must be reported to those government agencies under the 2003 U.S. Child Abuse Protection and Treatment Act, known as CAPTA. Before infants are sent home with their parents who might be struggling with drug addiction themselves, the county agencies are required to assess the home environment and create a safe-care plan, including services to drug-dependent parents.
But Pennsylvania's interpretation of the federal law has led to confusion among health care providers about when child protective services should be notified, according to county officials and child advocates.
The Pennsylvania Department of Human Services interpreted the federal mandate to apply only to babies whose mothers took illegal drugs or misused prescription drugs during pregnancy. As a result, health care providers aren't required to report drug-exposed babies born to mothers who were legally prescribed narcotics — like oxycodone or heroin —replacement drugs like methadone — if they took them as directed under medical supervision.
The full extent of the number of drug-exposed newborns in Pennsylvania is unknown because the only data collected is on those covered by Medicaid, the federal health insurance program for the poor and disabled. No agency collects newborn-exposure data on the privately insured.
The prescribed-narcotics exception in Pennsylvania law was intended to reduce the social stigma surrounding parental substance abuse, which discourages pregnant women from entering drug treatment, said Cathleen Palm, founder and executive director of the Center for Children's Justice in Berks County. But the exception created unanticipated consequences, she added.
“It takes the eyes off the baby because you don’t want to punish the mom. But you need to focus on mom and baby. Sometimes parents with a drug history don’t need child welfare in their lives, but if you don’t check, you don’t know,” Palm said. “You’ve really diminished the commitment to the baby in an attempt, rightfully, to not judge the actions of the mom.”
The conflict between the state and federal laws also means some health care providers report all newborn narcotic exposures and others only report exposure to illegal drugs, as evidenced by discrepancies in the numbers reported on the local and state levels, child welfare officials and advocates say.
The number of drug-exposed births at St. Mary Medical Center increased from 185 in 2014 to 270 of the 2,291 Middletown hospital's births last year, officials said. St. Mary reports all drug-exposed births to child welfare, whether the drug the mother used was legal or illegal.
State hospital discharge records show only 93 newborns were reported as being exposed to “illegal” drugs at all three Bucks County hospitals with maternity units during fiscal year 2014-15, the most recent year available. St. Mary didn't have fiscal year data available for drug-exposed births, but a hospital official said the state discharge data was inaccurate.
"In some situations, we can discern between babies born with exposure to legal versus illegal drugs, however, our ability to draw that distinction relies on the mom's health history and a drug screen of the baby, " Dr. Carrie Hufnal, interim director of St. Mary's Neonatal Intensive Care Unit. "A drug screen in and of itself will only reflect exposure to opiates but will not tell us if the exposure is related to prescription or street drug use."
Bucks County Children and Youth received 209 hospital referrals under CAPTA for babies born to county residents last year, up from 129 in 2015. The first six months of this year, the agency received 112 referrals, according to agency director Lynne Kallus-Rainey. But she suspects that there are more births that should have been reported.
"We know not all (drug-exposed) babies are being reported,” Kallus-Rainey said. “We are not totally able to access when, and why, some get reported, while others don't
In Montgomery County, Abington Hospital-Jefferson Health has seen its drug-exposed births increase from 31 to 93 between the 2012-13 and 2015-16 fiscal years. The hospital also reports all drug-exposed births involving prescribed and illegal drugs, but doesn't differentiate between exposures to legal or illegal narcotics, an official said.
Montgomery County Children and Youth Director Laurie O'Connor acknowledged the 114 CAPTA referrals it received from area hospitals last year may not represent all drug-exposed newborns born to county residents, because referrals for drug-exposed infants under age 1 without any hospital record of newborn exposure are classified differently. “It may be suspected that the child was born drug-affected, given the mother’s history of addiction, but without completion of testing by the hospital (at birth) there is only speculation,” O’Connor said.
Palm suspects confusion over the reporting law coupled with a lack of understanding about prenatal drug exposure and its prevalence is responsible for the divergence in reporting.
"No one has really been paying attention to this issue," she said. “There is a big bucket of kids that we may not know if they were prenatally exposed to drugs, so all the provisions of law and the safety mechanism for them may never get triggered.”
State vs. local laws
The state's CAPTA interpretation became legally binding in 2015, when the Pennsylvania Child Protective Services Law was amended. However, Congress updated the federal law in 2016 to clarify that health care providers must refer all cases of drug-exposed infants to child welfare agencies, regardless of whether the exposure was to legal or illegal drugs.
The Pennsylvania Department of Human Services was supposed to submit a plan to the federal government to bring the state into compliance or risk losing child welfare service funding by June 30, but it recently received an extension. The state agency has assembled a group to develop recommendations for lawmakers to amend Pennsylvania's law to bring the state into compliance with the infrastructure and guidance necessary, according to state Rep. Katharine Watson, R-144, of Warrington. As chairwoman of the House Children and Youth Committee, she gets updates from the group.
DHS said there is no timeline to fix the law and Watson acknowledged the state law is failing some babies.
“I’m very much worried about that,” she said. “I have a problem that we knowingly are sending babies home with people who aren’t ready to take care of them.”
Complicating the situation is the fact that not all infants born exposed to drugs will develop withdrawal symptoms, neonatal doctors said. And while symptoms typically appear within 24 hours after birth, they can appear up to 10 days later — long after most infants leave the hospital.
Health care providers say the growing number of pregnant and parenting women who secretly misuse legally prescribed or illegally obtained narcotics complicates their ability to identify drug-exposed newborns.
This year, Abington Hospital-Jefferson Health anticipates delivering 120 drug-exposed babies, said Dr. Joel Sorosky, chairman of the OB-GYN department. Three-quarters of them will be born to privately insured women taking prescribed opioids for pain-related issues — a number that has tripled over the last four years. Some of these women don't tell their obstetrician about the drug use because they don't believe they're drug-dependent, Sorosky said, and most are unaware the fetus can become dependent on opioids in as little as two weeks.
Area hospitals also are seeing pregnant heroin users who self-medicate with opioids like methadone or suboxone they obtained illegally, believing it's healthier for the baby and a way to stay under government radar, health workers and drug treatment specialists said.
If a pregnant woman discloses dependence early, hospitals can connect the family with alternative pain management or drug treatment providers, Sorosky said. At a minimum, neonatal staff can prepare for observation and, if needed, medical intervention, if the infant experiences withdrawal, he said.
"The challenge comes when we are caught unaware and the baby withdrawals," Sorosky said. "Sometimes, the significant other is just as surprised and it creates an adversarial relationship (between the parents). We can avoid that by knowing early on and have a chance to treat the mother and help the baby.”
A Bucks County lawmaker has introduced legislation that would close a loophole in state law that allows some newborns with prenatal drug exposure to fall under the radar of county child protection authorities, violating a 2003 federal law.
Rep. Katharine Watson, R-144, of Warrington, on Friday introduced a bill that would reverse a 2015 amendment to the state’s Child Protective Services Act that created exempted health care providers from reporting infants born exposed to drugs when mothers were legally prescribed addictive narcotics during pregnancy.
“For the sake of the adult, for the sake of that child, I think we need to check on them,” said Watson, who also chairs the House Child and Youth Committee. “At the very best, if you are by yourself, recovery is tough, and add in the responsibility of another human life with it, and I cannot imagine.”
The legislation was introduced weeks after this news organization exposed the dramatic gap between the number of drug-exposed newborns reported under Medicaid and the number of child welfare reports for prenatal drug exposure. The story was part of our ongoing “Born into Addiction” series, which examines the impact of the drug epidemic, led by opioid and opiate addiction, on the lives of children.
Watson, who credited the series with inspiring the legislation, cited data from the series in her co-sponsorship memo.
Our findings — which Watson called “startling" — included data showing that just under 2,100 Pennsylvania newborns whose deliveries were funded by Medicaid health insurance were diagnosed with narcotics withdrawal syndrome. But, only 972 newborns were referred to county child welfare authorities for assessment.
In 2015, the first year the state broke out data for substance-exposed newborns, 707 infants born to mothers on Medicaid were reported to child welfare as being exposed to narcotics, but 2,350 babies were diagnosed with withdrawal from narcotics, according to the statistics from the state Department of Human Services.
None of those numbers include exposed newborns born to mothers with private health insurance because no agencies collect that data.
The gap shouldn't exist under the federal Child Abuse Protection and Treatment Act, known as CAPTA. It requires health care providers to advise child welfare authorities of all prenatal exposure to narcotics or alcohol or infants that show signs of withdrawal. Those authorities are required to assess the infant’s home environment and develop a safe-care plan, which may include services to drug-dependent parents, before a newborn is sent home.
Congress updated the federal law again in 2016 to clarify that health care providers must refer all cases of drug-exposed infants to child welfare agencies, regardless of whether the exposure was to legal or illegal drugs. But the Pennsylvania Department of Human Services has long interpreted the federal mandate to apply only to babies whose mothers took illegal or unprescribed drugs or misused prescription drugs during pregnancy. Its interpretation was made law when it was added to an update of the state’s child protection law in 2015.
As a result, Pennsylvania health care providers involved in the delivery or care of substance-exposed newborn aren't required to report the birth to child protection — and child protection officials aren't obligated to get assess them if the mothers were legally prescribed narcotics, such as oxycodone or methadone.
Medication Assisted Therapy uses opiate replacement drugs as part of drug treatment of pregnant women dependent on synthetic opiods or opiates like heroin. The therapy exposes developing babies to the drugs, which increases their risk of experiencing narcotic withdrawal symptoms soon after birth.
The Pennsylvania Department of Human Services has created a task force to develop recommendations for lawmakers to amend the state law to bring it into compliance with the federal law. It failed to meet a June 30 federal deadline to submit a plan, but received an extension.
“Our state’s laws should not allow the sending of any substance-exposed newborns — or any newborn, for that matter — home with mothers who by virtue of their substance abuse disorder are unable to properly care for the infant or who may put the infant in serious danger,” Watson said.
She emphasized the change shouldn't be seen as punitive against women who enter drug treatment during pregnancy or women in long-term recovery. Watson said she believes her bill strikes a balance between protecting vulnerable newborns and encouraging pregnant women to enter or continue drug treatment.
Child advocate Cathleen Palm agreed the challenge for advocates and lawmakers is finding balance between recognizing the needs of these newborns and parents who may be struggling with addiction. Palm is the founder and director of the Center for Children’s Justice in Berks County.
“I would encourage people to look beyond what we have always done, which is divide ourselves into the 'camp for mom' or the 'camp for the baby,' ” Palm said. “I think we all have to be in the camp for the mom and the baby together.”
Palm said she suspects the bill will give lawmakers the opportunity to talk about issues related to funding for treatment for pregnant and parenting women and related issues such as safe housing and child care, which are the two biggest barriers that prevent women from entering drug treatment.
Rep. Gene DiGirolamo, R-18, of Bensalem, who chairs the House Human Services Committee, and Rep. John Galloway, D-140, of Falls, on Monday said they support Watson’s bill and plan to sign on as cosponsors. Reps. Todd Stephens, R-151, of Horsham, Thomas Murt, R-152, of Upper Moreland, and Bernie O’Neill, R-29, of Warminster are already cosponsors.
“Of course, I'm concerned,” Rep. Scott Petri, R-178, of New Hope, wrote in an email expressing support for the bill. “You would have to be heartless to not want to help newborn children who have become addicted through no fault of their own.”
Matt Bellina is dying. But he hopes he lives long enough to play a game of touch football with his oldest son.
It’s a wish that his 5-year-old son, JP, made on a dandelion he picked during a walk with his dad last year.
“Like any dad, I knew my job was to help him make his wish come true,” Bellina said.
But medical textbooks suggest that Bellina, a 34-year-old father of three from Northampton, is nearing the end of his life. He has amyotrophic lateral sclerosis, better known as ALS or Lou Gehrig’s disease, an incurable and fatal disorder that progressively attacks the central nervous system. Those with the condition eventually lose their ability to speak, eat, move and breathe. The former U.S. Navy pilot can feed himself, but he can no longer write. He uses a walker and a wheelchair to get around.
When Bellina was definitively diagnosed with ALS in 2014 — eight years after he first showed symptoms — his illness was too far along for one federally approved drug for ALS patients and not advanced enough for the other. Clinical trials for new drugs are underway, but Bellina hasn’t qualified for them. Drug companies typically seek participants in early stages of a disease since the approval process can take at least 10 years — double the average life expectancy of an ALS patient.
And while federal law gives Bellina and others with terminal illnesses access to clinical trials of treatments and drugs that haven't been approved by the U.S. Food and Drug Administration, the "compassionate use" process to get that access is time-consuming and burdensome.
“If I’m not going to make it anyway, why shouldn’t I get to try (experimental drugs)?” asked Bellina, who has testified before Congress and campaigned online to get people with terminal illnesses better access to potentially lifesaving drugs.
Right to Try bills, laws
Thirty-seven states and the U.S. Senate agree.
They've passed so-called Right to Try bills and state laws, which are designed to ease the process for terminally ill patients to get experimental drugs and treatments.
Bills are in various stages of action in the Pennsylvania and New Jersey legislatures. However, since state laws can't supersede federal law, they are mostly symbolic.
The U.S. Senate bill, which passed earlier this month, would let terminally ill patients circumvent the FDA’s lengthy "compassionate use" application to get speedier access to experimental drugs.
A patient's doctor could directly request such medications from drug companies that have successfully completed preliminary safety testing, said Starlee Coleman, a spokeswoman for the Goldwater Institute. The Libertarian think tank developed the template on which the federal and most state bills are modeled.
Drug companies would continue to advise the FDA of adverse effects on terminally ill patients as they do on everyone in a clinical trial, but data on "compassionate use" patients couldn't be used against pharmaceutical companies in the drug approval process as it is now, Coleman said. The Senate bill also protects drug companies and prescribing doctors from liability for bad reactions to these experimental drugs.
The House version of the bill, co-sponsored by Bucks County Congressman Brian Fitzpatrick, R-8, of Middletown, was introduced earlier this year and is expected to be voted on by the full House, though there's no indication when. Fitzpatrick described the measure as another avenue to expand access beyond the existing FDA protocol.
“For too many, access to these potentially lifesaving treatments will come too late, or not at all,” Fitzpatrick said in a statement. “Whether it’s a father courageously battling ALS or a brave child living with Duchenne muscular dystrophy, they deserve the right to try.”
Journey to diagnosis
Bellina was 28 and a new dad when a neurologist first told him the symptoms that had plagued him for years might be ALS. He experienced balance problems, persistent muscle aches and hand cramping when he was a Navy pilot flying electronic-warfare jets.
The Navy grounded Bellina about three years after he first noticed the twitching in his hands. In 2012, he was placed on administrative duty and deployed to east Africa and the Korean peninsula to work as an anti-terrorism officer. He medically retired with the rank of lieutenant commander in 2015.
Obtaining his diagnosis was complicated by his youth and lack of a family history of ALS, Bellina explained. When it was finally confirmed in 2014, he was 31. JP was almost 2 and Kip was 2 months old.
Bellina has outlived others with his diagnosis and his doctors suspect he may have a slower progressing form of the disease than most people.
“I’m really lucky to do what I can do,” he said.
And what he can do lately is more than what he could do earlier this year.
Two weeks before his youngest son, Paxson, was born 5 months ago, Bellina started taking an experimental drug provided by a manufacturer he declined to identify. It was the first and only drug company to grant his "compassionate use" out of the nearly 20 he approached.
Since he started the medication, Bellina and his wife, Caitlin, said they've noticed improvements. He can get out of a chair unassisted. He can whistle again. His breathing is better. He has more energy. He no longer drags his feet. And his muscle cramps have eased.
Vomiting, the drug's main side effect, is tolerable.
“When you’re dying, side effects are … eh,” he said.
Longtime state Rep. Robert Godshall, R-53, of Souderton, knows what that's like.
He's the driving force behind the Pennsylvania bill, which was inspired by his firsthand experience as a patient with a terminal diagnosis and no traditional medical options. Twelve years ago, Godshall had an unapproved stem cell transplant for multiple myeloma, a fatal, incurable blood cancer. The FDA age cutoff for the procedure was 65. Godshall was 72.
Now 84, Godshall said he used his political clout to pressure doctors at the University of Pennsylvania Health System to ignore medical protocol. The approval process took two months and involved legal paperwork that absolved the hospital and doctors from liability.
The transplant, which he said his health insurance covered, kept the disease at bay for two years. That was enough time for Godshall to enroll in a Penn clinical trial of a new drug. He was in the trial until recently, when the drug stopped working after 10 years and his cancer returned “full-blown,” Godshall said.
“I don’t think you should have to be in the Legislature to save your life,” he said.
Some medical ethicists, including Art Caplan, argue there is no need for Right to Try legislation.
The FDA has historically approved 99 percent of "compassionate use" requests, which typically number fewer than 2,000 a year, he said, and the agency recently streamlined the process to address time lags. The real obstacle for patients is drug companies that may reject compassionate use requests for a variety of reasons, including fear an adverse effect could delay FDA approvalas it could under current law, he said.
“The decisions are still in the hands of drug companies that have the research and nothing about these laws shapes their willingness to give the drug,” said Caplan, founding director of the medical ethics division at New York University’s Langone Medical Center.
Right to Try laws generally don't address the price of some experimental drugs or require insurers to cover them, or treat people for potential medical complications from experimental drugs, Caplan said. There's no funding to help lower income people afford the drugs or to assist smaller drug companies to make them available, he added.
Finally, Caplan said, using experimental drugs could risk patient eligibility for end-of-life supports, including hospice and home health care — depending on their insurance coverage.
“I don’t see (the federal law) making a wit of difference for access," Caplan said. "It’s nice to pass feel-good laws, but families will quickly find if they want to get drugs from little companies, they may have to pay a lot of money and travel to get the drug.”