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Science Policy Around the Web – March 27, 2018

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By: Patrick Wright, Ph.D

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source: pxhere

Right to Try Drug Access

Why Can’t Dying Patients Get the Drugs They Want?

The United States House of Representatives passed “Right to Try” legislation last week (HR 5247, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018”), which allows terminally ill patients access to experimental drugs that are only required to have completed Phase 1 of a clinical trial, bypassing approval of the Food and Drug Administration (FDA). These patients are those with life-threatening illnesses who have exhausted approved treatment options and are not eligible to participate in a clinical trial (e.g. due to not meeting inclusion criteria) designed to evaluate the desired drug. However, this access still requires cooperation and permission from the drug companies themselves. Hesitation on the side of these companies can be rooted in the potential risk of jeopardizing ongoing clinical trials and the long process of bringing a drug to market. Furthermore, drug companies often do not have a sufficient extra supply of a product to provide to patients. The logistics of granting access could slow efforts to get the drug approved. Opponents of this legislation cite patient safety concerns and the failure to address the fundamental issue of pharmaceutical company denial of access as the most significant problems that still must be addressed.

Some companies acknowledge the importance of FDA oversight and would continue to seek FDA permission even if a Right-to-Try bill becomes law. Dr. Joanne Waldstreicher, the Chief Medical Officer of Johnson & Johnson, said “In our view, the FDA plays a really important role.” It has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.” The legislation includes language that could potentially encourage companies to participate, including preventing the FDA from considering the experiences of patients using the drug when approving drugs. The FDA itself already approves 99 percent of applications to its expanded access program for access to investigational drugs for patients facing serious illnesses.

The Right to Try campaign was initiated by the Goldwater Institute, a libertarian, free-market public policy research and litigation organization, and championed by Vice President Mike Pence. Currently, Right to Try legislation has been enacted by 38 states. Victor Riches, president and Chief Executive Officer of the Goldwater Institute said the passing of this bill “is a win for patients. Millions of Americans who have been told they are out of options and it’s time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first.”

In August 2017, the United States Senate unanimously also passed a Right to Try bill (S 204); notably, it was passed under pressure by Ron Johnson (R-WI) who threatened to hold up a five-year reauthorization of FDA user fee programs if he did not get a vote on the bill. However, the narrower House bill has key differences compared to the Senate version, with House Energy and Commerce Committee Chairman Greg Walden (R-OR), along with FDA Commissioner Scott Gottlieb and other interest groups, having specified additional provisions including limiting the types of patients who can access the pathway and giving the FDA more information regarding the use of the pathway. Because the House bill differs from the earlier Senate bill, the Senate must vote on this revised version. Last week, Senator Minority Leader Chuck Schumer (D-NY) blocked Ron Johnson’s attempt to secure unanimous consent in the Senate to pass the House version of the bill. Senator Schumer stated that the Senate had already passed its version and that he wanted to work on a compromise bill.

(Katie Thomas, The New York Times)

Animal Welfare

Congress Orders USDA to Restore Transparency, Completeness, to Animal Welfare Reports

The U.S. Department of Agriculture (USDA) blacked out a public database containing animal welfare inspection reports and records of enforcement actions that the USDA carried out against violations of the Animal Welfare Act in early 2017. The records were often later reposted after varying levels of redaction, eliciting resistance and objection from proponents of animal research and animal welfare activist groups. Last week, Congress released a report that accompanied the USDA’s 2018 spending bill. It stated that these redactions and the obfuscation in accessing USDA information on inspections and their subsequent enforcement violates previous congressional direction and that “the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws.”

On the same day that the report was released, the Humane Society of the United States (HSUS) filed a lawsuit against the Animal and Plant Health Inspection Service (APHIS), the USDA entity responsible for conducting animal welfare inspections. HSUS had requested documentation (e.g. inspection reports) for three puppy breeding facilities (“puppy mills”) via the Freedom of Information Act (FOIA) and were, in response, provided reports by APHIS with significant contents redacted. The USDA’s FOIA office wrote that because the requested reports were about businesses that operated out of an individual’s private home, they could not be disclosed without that person’s consent. This is not the first lawsuit in response to the blackout that has been filed by animal welfare groups against the USDA. The Animal Legal Defense Fund as part of a coalition with other animal activist organizations (Stop Animal Exploitation Now, Companion Animal Protection Society, and Animal Folks) previously filed a lawsuit in February 2017 against the USDA’s handling of inspection report transparency and availability (Animal Legal Defense Fund v United States Department of Agriculture) that was dismissed by federal Judge William H. Orrick on the grounds that FOIA provides an “adequate, alternate remedy”. The coalition has since appealed the decision.

To explicitly describe the approach and process underlying the blackout and redactions, APHIS states on its website: “APHIS, during the past year, has conducted a comprehensive review of the information it posts on its website for the general public to view. To conduct the review, the entire agency search tool database, along with additional documents, was taken off line. As a result of this review, APHIS has removed certain personal information from APHIS’ website involving the Horse Protection Act and the Animal Welfare Act. APHIS recently reposted certain inspection reports and research facility annual reports that were determined to be appropriate for reposting.” It also states “The agency will continue to review records and determine which information is appropriate for reposting. Those seeking information from APHIS regarding inspection reports not currently posted to the website, regulatory correspondence, and enforcement related matters may submit FOIA requests for that information.”

It appears that the language in the new Congressional report, part of the new omnibus spending bill that was just approved by Congress and President Donald Trump, has support among the animal welfare community. Cathy Liss, president of the Animal Welfare Institute, based out of Washington, D.C., stated “The Animal Welfare Institute applauds Congress for forcing USDA to lift its veil of secrecy.” Similarly, Kathleen Conlee, vice president for animal research at HSUS said she is “very pleased” with the report and that the “HSUS has been working closely with Members of Congress over the past year to address USDA’s outrageous purge and redaction of these vital documents.”

(Meredith Wadman, Science)

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Written by sciencepolicyforall

March 27, 2018 at 12:27 pm

Science Policy Around the Web – February 13, 2018

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By: Saurav Seshadri, PhD

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source: pixabay

Experimental drugs

Trump Endorses “Right to Try” for Terminally Ill Patients

Proponents of the ‘right to try’ received some encouragement from President Trump’s recent State of the Union address, in which he announced his support for such legislation at the federal level.  Right to Try laws are designed to allow terminally ill patients to obtain unapproved but possibly lifesaving drugs directly from pharmaceutical companies, without involving the FDA.  While such laws already exist in 38 states, they are currently superseded by the Food, Drug, and Cosmetic Act; a bill that would eliminate this legal conflict was passed by the Senate last August, but has yet to be approved by the House of Representatives.

In general, Right to Try laws permit terminal patients, with their informed consent, to access investigational treatments if recommended by a physician.  However, they do not mandate that the manufacturer provide the drug or that insurance cover it, and in some cases, they absolve drugmakers and physicians from liability for adverse outcomes.  In addition, the FDA already offers a path to treatment for terminal patients under its ‘expanded access’ program, in which patients are treated as clinical trial participants and their doctor’s office becomes a satellite site, with appropriate regulatory oversight.  Opponents of Right to Try legislation, including FDA Commissioner Scott Gottlieb, argue that bypassing such oversight would critically undermine the clinical trial process (for example, a patient death from a drug obtained under a Right to Try law would not factor into the FDA’s consideration of that drug for approval).  They also suggest that these laws provide false hope for desperate patients – experimental drugs need only clear the safety phase of FDA trials, meaning no data exists on their efficacy – and open patients up to risks of physical harm and medical fraud.

Despite these concerns, Right to Try laws have gained momentum on the strength of anecdotal success stories, and politicians’ unwillingness to appear heartless towards patients suffering from terminal diseases.  Yet in reality, without securing financial support for patients, these laws are likely to result in some patients going bankrupt. Without requiring that treatments be demonstrated to be beneficial and at least safe, these laws are likely to result in patients pursuing ineffective treatments, while reducing their quality of life by enduring side effects, risking complications, and forgoing hospice care.  The future of Right to Try legislation may be influenced by new Health and Homeland Security Secretary (and former Eli Lilly executive) Alex Azar, who seems likely to support Trump’s agenda, though he didn’t mention the right to try in his response to the State of the Union address.  Ideally, the final bill will prioritize the existing drug review process, ensuring safety for the majority of patients while still providing hope for the sickest.

(Ike Swetlitz, STAT news)

Chemical safety

The truth about glyphosate may be getting lost in the weeds

The World Health Organization (WHO) kicked off a massive controversy in 2015 with its report labeling glyphosate, a component of an herbicide marketed by Monsanto, as ‘probably carcinogenic to humans’.  The report has faced stiff opposition from Republican Representatives on the US House Science, Space, and Technology Committee, largely fueled by a pair of Reuters reports suggesting that key data was suppressed by the WHO to support its conclusion.  Now Dr. Christopher Wild, Director of the group that conducted the research (the IARC, International Agency for Research on Cancer) has sent a detailed response to the Committee to rebut these criticisms and defend its original finding.

The response, which was presented at a recent Committee hearing by Democratic Representative Suzanne Bonamici, specifically addresses two issues raised by Reuters.  First, that a senior scientist failed to disclose data that would have exonerated glyphosate: the data was unpublished and therefore didn’t meet IARC’s criteria for consideration.  Second, that the published version of the report had several changes from an earlier draft, all of which involved deleting or revising statements that cast doubt on glyphosate’s link to cancer.  Dr. Wild claims that most of these changes were related to a single review article, whose conclusions were reconsidered when it was found to have been ghostwritten by a Monsanto scientist, and that its drafts are works in progress and therefore confidential.  Still, the response doesn’t explain the IARC’s discrepancy with other regulatory agencies: the European Food Safety Authority (EFSA) and US Environmental Protection Agency (EPA) have both found glyphosate to be safe, and claim their review processes are more transparent than the IARC’s.

The IARC’s stance on glyphosate puts it in a delicate position with the US government, from which it receives ‘valuable support’, especially as the topic becomes more partisan.  Republican lawmakers have already threatened to pull funding to the IARC, ostensibly over its refusal to provide a witness for the hearing (Dr. Wild invited them to visit his facility in France instead).  On the other side, the EPA’s assessment has been called into question by the discovery that an EPA official may have colluded with Monsanto to ‘kill’ investigation into glyphosate, leading Democratic Representative Ted Lieu to request a probe into the issue.  In the midst of a heated debate on climate change, the glyphosate story may initially seem to be another case of Republicans denying science to fight regulations and side with big business; however, the reality may be more complicated.  A recent protest in Paris by farmers, opposed to a proposed ban on glyphosate, highlights how those most affected by such policies must balance their economic stability against potential health risks.  Ultimately, though lawmakers may earn political points by siding with these individuals, if the price is discrediting accurate science and eroding public trust in regulatory agencies, no one wins.

(Corbin Hiar, E&E News)

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Written by sciencepolicyforall

February 13, 2018 at 6:01 pm