IPAK also conducts and supports research in the following Project Areas. Donations can be made to specific Project Areas, or to the IPAK General Fund.
ADHD Overdiagnosis In 1995, Dr. Gretchen LaFever-Watson and colleagues at Eastern Virginia Medical School conducted a study that found that ADHD was overdiagnosed. They worked to set up community programs to help students perform better in school without the use of amphetimines. Dr. Watson was targeted by the pharmaceutical industry, these highly effective programs were shut down. The US Centers for Disease Control now recognizes that ADHD is overdiagnosed. It is now widely recognized as a serious epidemic of overdiagnosis, with inappropriate medication of millions of children. Worldwide, ADHD is diagnosed at a rate between 1% and 3%. In some areas in the US, ADHD is diagnosed at a rate as high at 20%. These facts earned ADHD Overdiagnosis a prominent place in the book by our Founder, “Cures vs. Profits: Success Stories in Translational Research”. IPAK works with researchers, educators, parents, and clinicians to verify ADHD diagnosis and to educate the public and stakeholders on the current status of research on the long-term safety and efficacy of the use of drugs being used to treat ADHD. Funds to support our activities can be donated directly to the IPAK ADHD Overdiagnosis Fund.
Accuracy in Treatments. Patients who endure chemotherapy for some cancers can have tissue from their tumors tested in the lab to determine if they are likely to respond, or not respond, to the chemotherapies available for their type of cancer. This prevents them from wasting time and enduring side effects of ineffective treatments during a critical period of time. Empowered by the information from such assays, patients and their doctors can make more informed choices about treatment options. The research behind many of these assays is robust and extremely compelling. However, the FDA is stalemated on the classification of such assays, and has allowed them to linger in a grey area as “Laboratory Developed Tests”. This leaves reimbursement decisions up to payers (insurance companies), leaving many patients either in the dark, or having to pay for the assays on their own. It makes sense for payers to provide coverage, otherwise they end of up paying for a larger number of ineffective treatments. Some insurers have studied the research for specific assays, and see the clinical and economic utility, provide coverage. Some, however, do not. IPAK works with patients, doctors, and other stakeholder to insure proper interpretation of the results from research studies on chemosensitivity and chemoresistance assays, such at Helomics’ ChemoFX test for gynecological cancers. We want to spread awareness of these assays, and bring the science to bear on the policy makers’ decisions. We will also provide partial payment for qualified patients from donations made to support this project area. Funds to support our activities can be donated directly to the IPAK ADHD Accurate Treatments Fund.
Compassionate Use Paperwork Simplification. Patients at the end stage of terminal illnesses often have little time, energy and resources to apply for Compassionate Use approval for experimental or off-label treatments that might save their life. Read Ken Kam’s Article on Compassionate Use in Forbes Magazine. Cancer Consulting/Clinical Trials Accrual The learning curve for new cancer patients is steep. Since the 2006, the Founder has been asked by friends, colleagues, family members and friends and acquaintances of friends and family members to assist people with new and existing cancer diagnoses to help them interpret their doctor’s advice, their medical reports, and to help them find best available routes to FDA-approved treatments. Sometimes acting as a Patient Advocate, he has guided people through diagnosis, treatment and care for breast cancer, prostate cancer, kidney cancer, pancreatic cancer, and a number of rare types of cancer. This rewarding personal service highlights a need in the community for a panel of knowledgeable and trained experts who will be available to help patients, and their doctors, find suitable and promising clinical trials. From an oncology research perspective, many clinical trials have trouble accruing sufficient numbers of patients to the study to insure statistical power. IPAK will provide, free of charge to the patient, consulting services to assist them in their understanding of the nature of their disease, the reason why specific treatment options may be inferior, or superior for them, and to help them identify (if necessary) additional diagnostic and prognostic tests and clinical trials that may aid in their survival. Donations to support these activities can be made to the IPAK Cancer Consulting/Clinical Trials Accrual Program Area Fund.
Colon Cancer Prevention. Each year in the US, 50,000 people die from colon cancer. This disease is highly preventable in many people via diet. However, lifestyle changes are sometimes difficult to maintain. In 2000, a group of researchers discovered that feeding a naturally occurring compound called Uroguanylin prevents colon cancer in mice. Our Founder gave a lecture of PharmEd Association Members on the likely utility of uroguanylin for the prevention of colon cancer fifteen years ago. He presented data that showed that if unchecked, 500,000 American would die from colon cancer over the next decade. Now, fifteen years later, a synthetic form of that compound is nearing FDA approval for use in intestinal disorders. While the company that manufactures the drug cannot make health claims that the drug will prevent colon cancer, as clinical trials have not yet been conducted to demonstrate efficacy in preventing colon cancer, there is every reason to believe that the widespread use of this drug in the treatment of chronic gastrointestinal conditions such as chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) will restore proper gut functioning, reduce inflammation, and decrease the incidence of colon cancer. IPAK, therefore, is engaged in a campaign to spread the word about the possible and likely utility of this drug in the prevention of colon cancer. We seek to understand, via retrospective studies and prospective studies, whether uroguanlyin-based treatments do, in fact, safely and effectively reduce colon cancer rates in high-risk populations. We therefore work, independently of Synergy Pharmaceuticals, to educate the high-risk colon cancer population about ongoing trials of the use of two uroguanlyin-based treatments (Plecanatide and SP-333) as potentially useful for the prevention of polyps formation and recurrence. We will help patients who want to enroll in such a study make connections. We will also act to encourage law makers to allow temporary exclusive profit rights to pharmaceutical industries that make important discoveries on the efficacy of naturally occurring compounds that may have profound and widespread public health consequences. Donations to support activities in this area can be donated to the IPAK Colon Cancer Prevention Fund.
FDA Clinical Trial "Gold Standard" Reform. Many clinical studies are restricted in their nature by ethics, by the size of the clinical population, and by factors outside of the investigator’s control. The results of randomized, prospective clinical trials often show significance changes in a clinical measurement (e.g., size of tumor, blood pressure) in a group of patients after treatment. However, FDA statisticians are trained to require significant differences between a treatment group, and a control group, even in Phase I and II clinical trials. Moreover, it has been known for years that pure randomization of patients to treatment and control arms causes many studies to have baseline differences. These differences are minimized when computational matching approaches are used during random allocation to insure an even distribution of factors between treatment and control groups. When computational matching is conducted, and the treatment group shows significant change due to treatment, but the control group does not show any major effect, the result is very likely due to the treatment being effective. However, such results are often eschewed as meaningless due to a fallacy in the early years of statistics. This topic is explored in detail in "Cures vs. Profits: Success Stories in Translational Research”. IPAK is working to effect reform to mandate consideration of these types of results as on par, or even superior to, results from the current gold standard across-group comparisons. Donations to support these activities can be made to the IPAK FDA Clinical Trials Reform Project Area Fund.
Infectious Disease Rapid Assay Development. Emerging diseases like Ebola require rapid assay development – and they must be both highly sensitive, and highly specific. Working with investigators at Penn State University and the University of Illinois Urbana-Champaign, IPAK is poised to create a rapid assay development workflow that use novel molecular signal amplication techniques to enable fast, accurate and safe field testing for infectious agents. Derived from the Ebola Rapid Assay Development Consortium, this group focuses on solving the problem of detection computationally, building real-life detectors after extensive laboratory validation of the sensitivity and specificity of the component molecules. Donations to support these activities can be made to the IPAK Infectious Disease Rapid Assay Development Project Area. Total Outcomes Awareness No area of business can thrive without accurate accounting of customer satisfaction. It is ironic, therefore, that after the corporatization of health care, information on the outcome of one specific treatment option compared to others is difficult to obtain. Outcomes research is critically important to improve health care practice and to reduce costs. It is also critically important to both patients and payers in their selection of treatment options. It would seem critically important, therefore, for medical industry to be required to collect and report outcomes of alternative means of care as a public service. Outcomes data would help health care providers self-assess their own efficacy. If conducted in a universal way across institutions and states, they could also rapidly learn of the most efficacious treatment options for their patients. Adverse events could also be reported, as well as unexpected interactions and side effects. Donations to support these activities can be made to the IPAK Total Outcomes Awareness Project Area.
Vaccine Safety Science Reform Few know that the level of evidence required to have vaccines approved for routine use is far lower than the level of evidence required for new drugs. The FDA called for the ban on Thiomerosal in vaccines many years ago - and the CDC has staunchly refused to remove it from all vaccines. Merck removed Thimerosal from pediatric vaccines in 2013 - but four vaccines remain that contain >25 ug of the ethyl mercury. In 2014, stunning revelations that the CDC Vaccine Safety science conducted that demonstrated, over and over, no link between regressive autism and vaccines was severely compromised by scientific misconducted alleged by a senior CDC scientist, Dr. William Thompson. IPAK will work with partners to explore ways to insure reform in the conduct of clinical studies and retrospective epidemiological studies to insurevalid Vaccine Safety science. Donations to support these activities can be made to the IPAK Vaccine Safety Project Area.
Veterans Mental Health. Suicide among war veterans is at an all-time high. Since 1999, there have been 5,127 deaths due to combat and war-related injuries. During the same period, there have been over 128,000 deaths among veterans due to suicide. Research in psychiatry has shown that suicides are more likely in veterans who have seen combat (although a new study by the Department of Veterans Affairs concludes otherwise). Risk factors have been studied, including evaluation of key words and phrases during combat veterans’ mental health sessions with clinical psychiatrists. IPAK is conducting research to identify ways not only to reduce the rates of suicide among veterans, but to research ways of predicting veterans likely to be of high risk for suicide, effectiveness of programs for integration, and the effects of long-term follow up counseling on veteran’s benefits. We will work to develop prediction algorithms that use risk factors and key words as features in generalizable multivariate prediction models that would be suitable for clinical use to calculate actionable probabilities of suicide and indicators of intervention. Donations to support these activities can be made to the IPAK Veterans Mental Health Project Area.