Showing posts with label regulation. Show all posts
Showing posts with label regulation. Show all posts

Friday, August 20, 2010

Commercialization of the Human Genome_Issues of Privacy and Protection

Last week, the California Department of Public Health (CDPH) instructed UC Berkeley to modify its “Bring Your Genes to Cal” program. From the beginning, UCB’s controversial plan to test the DNA of incoming freshman for three genes, brought into bold relief many of the complex questions that engulf emerging biotechnologies, for example: how best to protect privacy rights; informed consent; the integrity of medical testing and research; and how to identify and reduce conflicts of interest?

Mark Schlissel, UC Berkeley’s dean of biological sciences, underscored another issue likely to be the subject of ongoing consideration: academic freedom. Defending the UCB program against the CDPH’s interpretation of relevant law, Schlissel declared that, "We have taken every precaution and are committed to following the letter of the law…, but we believe this is a flawed reading of the statute that raises questions about who has control over teaching at the university…" How expansively we view academic freedom depends, in part, on recognizing the conflicts of interest that exist on the part of those doing the “teaching.”

Deep structural conflicts of interest exist when science-entrepreneurs, who may stand to benefit downstream from emerging biotechnologies, use their positions as university academics to normalize the commercialization of those technologies. UCB’s press release describes the lead professor associated with the program, Jasper Rine, as a “genetics professor.” Yet he, like many of his academic colleagues, has strong commercial ties to the industry developing genetic technologies. Rine has served on the advisory boards of a number of biotech companies and has co-founded several California biotech companies, including his own genetics testing company. UCB’s implicit endorsement of genetic testing as consumerism is especially audacious given the serious criticism that this type of testing has come under. Testifying at last week’s California Assembly Committee on Higher Education oversight hearing, Council for Responsible Genetics President, Jeremy Gruber, related that federal sources had dubbed such testing “snake oil,” and “not ready for prime time.”

From the 1940's to the 1960's, Princeton, Yale, Wellesley, and many other elite universities required incoming freshman to participate in medical anthropology/eugenic research by posing nude for photographs designed to document posture and body type, seeking correlations between physique and temperament. Since then, in the clear-sightedness of another era, many such photos have been destroyed. But many yet remain. How much humiliation and trauma could have been prevented if more disinterested authority could have prevailed? Those incoming freshmen who laid bare their DNA revealed the most intimate biological information not only of themselves but of those related to them. They chose to do so without prior opportunity to discuss the ramifications of their decision, without full disclosure of the scope of the conflicts of interest involved, and without clarity as to when or how the information would ultimately be disposed. They, and those who come after them, need protection from the overzealous interests and conflicts of interest of the institutions in which they arrive, trusting, to learn.

M. L. Tina Stevens, PhD
Director, Alliance for Humane Biotechnology
Visit AHB online

Tuesday, November 10, 2009

PFIZER PAYS 430 MILLION IN CRIMINAL FINES

Pfizer Broke the Law by Promoting Drugs for Unapproved Uses
BY DAVID EVANS Nov. 9 (Bloomberg) --
Prosecutor Michael Loucks remembers clearly when lawyers for Pfizer Inc., the world’s largest drug company, looked across the table and promised it wouldn’t break the law again.
It was January 2004, and the attorneys were negotiating in a conference room on the ninth floor of the federal courthouse in Boston, where Loucks was head of the health-care fraud unit of the U.S. Attorney’s Office. One of Pfizer’s units had been pushing doctors to prescribe an epilepsy drug called Neurontin for uses the Food and Drug Administration had never approved.
In the agreement the lawyers eventually hammered out, the Pfizer unit, Warner-Lambert, pleaded guilty to two felony counts of marketing a drug for unapproved uses.
New York-based Pfizer agreed to pay $430 million in criminal fines and civil penalties, and the company’s lawyers assured Loucks and three other prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes.
What Loucks, who’s now acting U.S. attorney in Boston, didn’t know until years later was that Pfizer managers were breaking that pledge not to practice so-called off-label marketing even before the ink was dry on their plea.
On the morning of Sept. 2, 2009, another Pfizer unit, Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.


For more on this interesting story with many details......go to this link:

Monday, November 2, 2009

AMGEN IN TROUBLE WITH DRUG KICKBACK SCHEME


States Sue Amgen Over Alleged Kickbacks Plan

By CHAD BRAY
NEW YORK—New York, 13 other states and the District of Columbia sued Amgen Inc. and other drug suppliers over an alleged kickback scheme designed to boost sales of the anemia drug Aranesp, New York Attorney General Andrew Cuomo said Friday.
Mr. Cuomo said in a statement the multistate intervenor lawsuit filed in U.S. District Court in Boston alleges that Amgen, AmerisourceBergen Corp., and AmerisourceBergen's drug wholesaler, ASD Healthcare, and specialty group purchasing unit International Nephrology Network encouraged doctors to bill third-party payers, such as Medicaid, for free samples of Aranesp.
David Polk, an Amgen spokesman, said in a statement, "We believe that the allegations are without merit, and we look forward to the opportunity to examine these matters with the states before the court."
Mr. Cuomo said the lawsuit alleges that Amgen conspired with INN and ASD Healthcare to offer improper kickbacks to medical providers—such as sham consultancy agreements, weekend retreats or other services—to induce them to purchase and prescribe Aranesp.
"Drugs should be prescribed to patients on the basis of need, effectiveness, and safety, not on a corporate giant's promise of an all-expense paid vacation," Mr. Cuomo said. "In an egregious violation of the law, Amgen allegedly bribed medical providers and left taxpayers footing the bill for free drug samples."
The lawsuit was filed in connection with a whistleblower complaint first brought in U.S. District Court in Boston in 2006 against Amgen and others for allegedly illegal marketing of Aranesp. The whistleblower complaint was brought on behalf of the U.S. government and a number of states, including New York.
Amgen's Mr. Polk said the company has a solid compliance program and a code of conduct called "Do The Right Thing." The company expects all employees to follow it at all times, he said.
Michael Kilpatric, an AmerisourceBergen spokesman, said in a statement, "We've had no contact in this case with anyone in the N.Y. AG's office or any other state attorneys general offices and we expect to defend ourselves vigorously. We have received a subpoena from the Department of Justice related to the issues that are set forth in this case and we have been cooperating fully with the Department of Justice, and DOJ has not intervened in this case to date."
The states which brought the suit Friday are California, Delaware, the District of Columbia, Florida, Hawaii, Illinois, Indiana, Louisiana, the Commonwealth of Massachusetts, Michigan, Nevada, New Hampshire, New York, Tennessee, and the Commonwealth of Virginia.
Write to Chad Bray at chad.bray@dowjones.com

Sunday, November 1, 2009

Public Trust in Public Health and Safety


Here is a link to a "must read", tongue in cheek article regarding public rights to public health and safety,.... or rather the lack of it. It is worth a read since it holds many truths about how our legal and regulatory systems are designed to enhanced unfettered corporate interests, crippling the public's trust and rights to public health and safety. Written by Carolyn Raffensperger...it is a winner.

Wednesday, April 1, 2009

SCIENTIFIC PROPAGANDA: THE EMBRYONIC STEM CELL AND REGULATION


It is amazing to me how much scientific propaganda, euphemisms, gibberish and skillful verbal engineering are used to promote the scientific agenda with disregard to public health and safety and bioethics. So I intend to post a “Scientific Propaganda” series every so often to enlighten the public toward intentional misinformation.

Below is an example of Scientific Propaganda Tactic #1:
ONLY PROVIDING PART OF THE ANSWER IN ORDER TO MISREPRESENT THE TRUTH


The Business Journal recently published an article asking Robyn Shapiro the following question concerning regulations imposed upon human embryonic stem cell research performed in private industry:

Q. For embryonic stem cell research going on in the private sector, are there rules or guidelines those researchers must follow?
Robyn Shapiro's answer: “The FDA (Food and Drug Administration) regulates this kind of research. It’s ironic, but at the end of January, the FDA gave approval for the first clinical trial use of embryonic stem cells in spinal cord conditions, so 10 patients are in that trial. I think (the FDA) spent a year looking at that, but that is, of course, privately funded research.”

(From Ms. Shapiro’s answer one gets the impression that private industry is stringently regulated. Wrong!)

The more complete answer should have been:
There are no regulations on the private sector in regards to human embryonic stem cell research except at the human clinical trial level. The FDA regulates private industry only during human clinic trials, but not basic research or developmental research. This lack of regulation includes the access and research use of the human embryo. Dangerous embryonic stem cell research is occurring in private industry; but it remains unseen and hidden since the private sector is under no federal regulations or obligation toward oversight. Private industry very often uses trade secret abuse to avoid public criticism and disclosure. Ethical and safety oversight is impossible in private industry since they are not regulated at the basic research level.
Please send your favorite scientific propaganda to watchdogonscience.