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Compassionate Use” Leaves Little Hope for Dying Patients

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Compassionate Use” Leaves Little Hope for Dying Patients DEAD ON ARRIVAL FEDERAL “COMPASSIONATE USE” LEAVES LITTLE HOPE FOR DYING PATIENTS By Mark Flatten, National Investigative Reporter, Goldwater Institute YOU ARE DYING AND HAVE NO HOPE. our disease is 100 percent medication is so rigged with bureaucracy fatal. It’s only a short time and disincentives that it is bound to fail before it kills you. in most cases. Critics say it was designed There are no treatments that way, ensuring that only a tiny number that have been approved of patients are able to navigate the by the federal Food and complex, costly, and time-consuming YDrug Administration. maze that must be cleared just to file a There is a new therapy that could compassionate use application for the FDA save your life. But it is still being tested to consider. in people who have the same disease in The problem with the current system is rigidly controlled studies called clinical not just that it takes doctors 100 hours or trials that you are too sick to qualify for. more to complete the application process It will be a decade or more before the for FDA approval. new drug is available to your doctor. You Or that clinical trials take too long and will be long dead by then. cost too much. What are you willing to do, and how Or that new cures for deadly diseases much risk are you prepared to take to try like cancer are typically being developed to save your life? by cash-strapped small companies that Those are questions thousands of risk financial ruin if they grant early access Americans face every year after being to their products to save the lives of dying diagnosed with a deadly disease for which patients. there is no cure, at least none that has It’s the way all of those things been approved by the FDA. interconnect into an unworkable system For them, their only chance at survival that strips dying patients of their final will be to get access to an innovative new option to save their own lives. drug before it’s too late. It is a system of all risks and no rewards. It may be a faint hope, or even a false And the lynchpin that binds it all one. But it is their only hope. together is the regulatory scheme created The FDA’s compassionate use program by the FDA. is supposed to be that one last chance. To sell a new drug in the United Formally known as expanded access, States, and make any money off of it, compassionate use is meant as a way to pharmaceutical developers must get treat dying patients with medications the FDA to certify that it is safe for use that are still being tested in clinical trials in humans and effective in treating the and are therefore not otherwise available. targeted condition. Compassionate use must be requested by The only way to prove that is through the patient’s doctor, endorsed by the com- clinical trials: slow, tightly controlled, pany that makes the drug, and approved carefully monitored tests that normally by officials at the FDA. consist of three phases in which the But an investigation by the Goldwater therapy is given to a select group of Institute shows that the entire system patients to gauge its effects. for gaining access to an unapproved 2 A DEAD ON ARRIVAL “The whole system is built to be completely nonfunctional. It’s a system that just is so fraught with barriers and disincentives and reasons not to do it.” DEAD ON ARRIVAL A 3 ith everything riding on those trials, Drug developers get no direct benefit from drug companies rarely do anything compassionate use. that could raise their risk of failure, They do not get government funding, and are rarely or draw the ire of the FDA. That paid for making their products available. especially includes giving their Even if the patient does well and makes a Wtreatment to a dying patient, whose death could be miraculous recovery, that does nothing to help the counted against the company seeking approval. product in formal clinical trials. Those facing imminent death cannot access a drug If something goes wrong, it is counted against the while it is being tested, even if early results show that drug by the FDA. it works better than existing treatments, unless they All serious reactions or patient deaths, called are among the fortunate few who qualify for clinical “adverse events,” must be reported to the FDA. The trials. That amounts to a death sentence for most agency can, and has, suspended clinical trials because patients, even though their cure may have already patients receiving treatment through compassionate been found. use have died. It takes an average of 10–15 years for a new drug to The FDA maintains that such suspensions are rare, get through testing and be approved by the FDA for but it is a widespread fear in the drug industry. sale to doctors and patients, according to government There also is the chance that a bad outcome and industry estimates. will cause investors to question a drug’s value and Most fail. abandon the company’s stock, leaving it with no way Drug companies spend an average of $1.4 billion to to raise the money necessary to continue testing. get a product approved by the FDA. The cost of bring- ing revolutionary new treatments to market can reach Loaded with Disincentives $5 billion. Virtually all of those costs must be paid by In short, the entire regulatory and financial structure of drug companies before they can sell their first dose. the drug industry is so loaded with disincentives that The trials are all or nothing. Failure at any stage treatment under compassionate use is rare by design. usually means the product is dead. “The whole system is built to be completely non- Small drug companies developing innovative functional. It’s a system that just is so fraught with treatments are normally a collection of scientists and barriers and disincentives and reasons not to do it,” businesspeople who find a new way to treat a disease said Steve Walker of the Abigail Alliance, a patient and set about raising money from private investors advocacy group. “Our entire system is set up, including to pay for the early stages of clinical trials, usually with very unchallengeable enforcement authority by through the sale of stock or equities. the FDA, to prevent people from gaining access to a Once the product reaches later stages of testing drug of any kind that has not yet been approved by and shows promise, the inventors typically sell it to a the FDA.” large drug company, either outright or through some The Goldwater Institute has spearheaded the type of licensing arrangement, according to industry adoption of state Right to Try laws, which allow experts and company records. That business plan doctors and drug companies to proceed without FDA evolved because few start-up drug developers will approval in providing treatment to dying patients who ever be able to raise the billions of dollars required to have no other options. Those laws have passed in take a product through all phases of clinical testing, 24 states with overwhelming bipartisan support and especially since they won’t make any money from the almost no opposition. drug until after the FDA approves it. Critics of Right to Try say it is not needed, that Only big pharmaceutical companies have that kind compassionate use under FDA rules is the appropriate of money, staff, and regulatory expertise. mechanism for dying patients to get the treatment For the small innovators, making their drugs they need. Drug companies are unlikely to risk the available to a dying patient through compassionate wrath of the FDA by providing their products to use is risky. patients based on state laws alone, so the laws will They often don’t have the staff to deal with not lead to widespread access to investigational patients or the money to provide their products medications, they argue. through compassionate use. But even critics concede that Right to Try laws Their primary selling point to investors is that have raised public and political pressure on the FDA their drug shows promise in clinical trials that are to change its system for allowing those with no proceeding smoothly. Any deviation is enough to send other options to seek treatment with investigational investors fleeing and potentially ruin the company. drugs. That includes Dr. Arthur Caplan, director of the 4 A DEAD ON ARRIVAL division of medical ethics at the New York University Beyond that, there is no way to know how many Langone Medical Center. doctors simply refuse to make compassionate use “Right to Try, as much as I fume and fuss about requests for individual patients because of the long, it, has brought the issue forward,” he said. “It has cumbersome, and costly process required by the FDA. pushed the issue to the forefront. Congress must pay “If you have to deliver the application at the top attention. Ethicists must pay attention; companies, level of Mount Everest, they will approve it,” said media. Even if I think the laws are not going to get us Garo Armen, chief executive officer of Agenus Inc., far in getting drugs to people, I think it put the issue a small biopharmaceutical company developing front and center.” immunotherapies to help treat cancer and other diseases. “The FDA will do the approval process, but ‘Successful Program’ everything that needs to be put into place, which is an FDA officials and their defenders insist the current sys- FDA requirement, makes the process very onerous.” tem works well, and the agency is not an impediment The best evidence against the FDA’s claim that to terminal patients getting the care they need.
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