Study Shows Whistle-Blowers from Drug Companies Suffer Hardship

A study conducted at Harvard University found that people who become informants of the U.S. government in health care fraud against the pharmaceutical companies, informants could receive financial rewards, but they suffer sever difficulties.
In fact, 82% of the 22 interviewed informants said that they had been subjected to various pressures from companies in response to their complaints and at least eight insiders said the financial consequences were "disastrous." One of them said: "I just could not get a job. I had to sell his house and I went under financially. Then it becomes really difficult ... I've lost everything, absolutely everything. "
"Whistle-blowers need more support in the process of bringing it forward," Dr. Aaron Kesselheim of Brigham and Women's Hospital in Boston said in a telephone interview.
The study gives an idea of ​​what happens when the whistle-blowers to sue the company under "Qui Tam" lawsuit, in which the individual goes to court and the federal government intervene if it finds evidence of illegal activity. The study said that the six insiders reported divorces, severe marital stress, or other family disputes at this time. Half of the respondents reported stress-related health problems, including shingles, psoriasis, autoimmune disorders, panic attacks, asthma, insomnia, migraine and generalized anxiety.
Kesselheim and his colleagues studied 17 cases of pharmaceutical whistle-blowing in 2001. The largest in the last year of $ 1.4 billion settlement in which Eli Lilly and Co. (LLY.N) was accused of improperly marketing its antipsychotic drug Zyprexa for children and elderly patients, as well as failure to provide information about the side effects of the drug.
Perhaps the most important aspect of this study was that the majority of informants to obtain money and the researchers found that there was no money motivation. Whistleblowers receive a share of the financial recoveries resulting from prosecutions and settlements. "They seemed to want to be right is not so, or to shed light on what was ethically compromised", Kesselheim said. Money was no motivation.
Informants typically found illegal practices, when they moved into a new company, or when they were promoted to new positions. Most tried to stop the practice, talking to the boss or a complaint. They often say just follow orders.
The study, described in a special report published in the May 13 issue of The New England Journal of Medicine, provides what may be the first reliable data on the experiences of those involved in a lawsuit under the federal false claims law.

Peptimmune Initiates Trial Of PI-2301 In Multiple Sclerosis Patients

Peptimmune, Inc a private biotechnology company, announced today that the doctors treated the first participant in a clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of PI-2301 in patients with secondary progressive MS (SP-MS). PI-2301 is a new peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.
Phase Ib multiple ascending dose, double-blind, placebo-controlled, randomized study will include up to fifty-three subjects with SP-MS, who will receive the drug once a week for four doses escalating cohorts. After you create security for potentially therapeutic doses and proof of pharmacologic mechanism, the company plans to begin its Phase II study in patients with multiple sclerosis in early 2009.
PI-2301 is a second generation peptide copolymer from a similar class of compounds in the form of Copaxone (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response to the immune system and thereby control of pathogenic autoimmune response observed in some disease. In one step of increasing the dose, double-blind, placebo-controlled, randomized study, all doses of PI-2301 was safe and well tolerated and no serious side effects were observed. Pharmacodynamic assays demonstrated evidence of immune exposure in accordance with the pharmacologic mechanism of action for PI-2301, and a dose-dependent pharmacokinetics was observed.
PI-2301 has been optimized using the new platform Peptimmune peptide chemistry and in preclinical studies, showed a much more powerful and effective than Copaxone in treating disease models of multiple sclerosis. PI-2301 has also shown efficacy in preclinical models of autoimmune diseases in which immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has introduced a high-quality synthesis and analytical methods that provide the highest level from batch to batch reproducibility in the production of PI-2301.
More than 400,000 Americans with multiple sclerosis (MS), MS, and may affect more than 2.5 million people worldwide. MS an autoimmune disease in which the immune system reacts against individuals of several components of nerve-insulating myelin. The effects of these immune attack can range from relatively benign to somewhat disabling to devastating as communication between the brain and other parts of the body is disturbed.

Medicare New Rules for Equal Visitation Rights for All Hospital Patients

Centers for Medicare and Medicaid Services today proposed new rules for hospitals that participate in the management of health programs that protect the rights of patients to choose their own visitors during their stay in hospital the hospital, including visitors who are same-sex domestic partners. These rules implement orders of President Obama released in April 2010 that "the participating hospitals may not refuse to visit the privilege on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity or disability."
The proposed rules, which will be updated to the current Conditions of Participation (COP), requires that each hospital has written policies and procedures, details of which patients visiting rights, including the patient's right to choose their visitors, and his or her representative for making critical health care system.
Hospitals often bar visitors who are not related to the patient by blood or marriage. Gay activists say that many of them do not respect the efforts of gay couples "to designate a partner to make medical decisions for them if they are seriously ill or injured.
The new rules will not apply only to same-sex unions. They will also affect widows and widowers who were not able to meet with a friend or companion. And they will allow members of some religious orders to designate someone other than family members to make medical decisions.
"Every patient deserves the basic right to appoint who they want to see while in the hospital," said Health and Human Services Kathleen Sebelius. "Today's proposed regulation would ensure that all patients have equal access to visitors of their choice, whether or not those visitors, or are perceived as members of the patient's family."
"This draft resolution is an important step forward in the rights of all Americans expect the same rights and privileges from the health care system, regardless of their personal and family situations," said Marilyn Tavenner, CMS acting administrator. "In turn, this rule promotes, patients and providers can expect improved patient experiences of care."

Anesthetics May Cause Pain After Surgery

Anesthesia drugs used for cutting pain during surgery may increase the pain and discomfort after surgery.
The conclusion from a team of researchers from Georgetown University Medical Center, and offers a mechanism of how anesthetics can cause pain after surgery.
The researchers suggest that "noxious" anesthesia drugs - which are the basic and most frequently used drugs in the market - information specific neurons in the central nervous system, and this leads to pain after surgery. However, another group of drugs anesthesia - sevoflurane - targeting the brain and spinal cord, have no side effects, but they are not as effective.
Scientists have found that side effects of "bad" drugs due to the way drugs affect the nerve cells receptor TRPA1. This receptor is strongly activated by contact with "bad" drugs, which leads to burning pain after surgery.
They tested the "bad" drugs in mice lacking TRPA1 receptors and found that mice anesthetic agents did not feel any pain. The researchers then tested how harmful drugs and sevoflurane in normal mice and found that those exposed to harmful drugs experienced pain and inflammation several hours after exposure to anesthetic.
Finding suggests that the move to a group of anesthetic drugs with no side effects, or to develop more sophisticated methods.
"The choice of anesthesia may be a contributing factor of postoperative pain and inflammation," said Gerard Ahern, who led the study.

New Compounds May Lead to Treatments for Ebola, Marburg Viruses

There is currently no vaccine or effective treatment of Ebola and Marburg filoviruses, two deadly viruses that cause hemorrhagic fever, but a new discovery of U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and AVI BioPharma could lead to the first vaccine may protect against viruses that have a 90% mortality in humans.PMO compounds block viral replication in animal studies
Travis K. Warren Research and his colleagues have found two compounds from a family known as antisense phosphorodiamidate morpholio oligomers, or in the PMO. These compounds block critical genetic viral sequences, viral replication to stop long enough to give the immune system time to protect against viruses and remove it from the body.
Nine monkeys exposed to Ebola virus, and eight of them received PMO compound called AVI-6002. The compound is protected 60% of monkeys infected with Ebola virus. In the second experiment, three of the five monkeys in each group survived at a dose of 40 mg of AVI-6002 per kilogram of body weight.
A second compound called PMO AVI-6003 protected 100% of the monkeys infected with Marburg virus Lake Victoria (Merv). Furthermore, it was more than 90% effective in mice and guinea pigs.

Both compounds appeared to protect animals when administered up to one hour after exposure, suggesting they may also be used to treat people who accidentally become infected in laboratories and hospital.
Ebola and Marburg viruses are usually transmitted through blood and body fluids. However, infection can occur through droplets, causing serious concern as a potential weapon in biological warfare or terrorism.
The researchers presented new applications of the study drug (IND) for AVI-6002 and AVI-6003, to U.S. Food and Drug (FDA) and are clinically tested on a small group of volunteers man.
According to the UN World Health Organization (WHO), about 1850 cases of Ebola have occurred since 1976, resulting in approximately 1,200 deaths.