AHRP in the News

Alliance for Human Research Protection in the Press

Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature

“This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that are the problem.”

Feb 12, 2005: Drug Regulators Are Trying to Quash Study, Senator Says – NY Times

Vera Sharav, president of the Alliance for Human Research Protection, said that the Vioxx story demonstrated that “the F.D.A. has abandoned its public responsibility to protect us from unsafe drugs and is standing by as drug companies market lethal drugs.”

Feb 11, 2005: 14 deaths force halt to drug in Canada – Hyperactivity remedy called threat to kids – Star-Ledger

“Why is the American public entitled to less safety than Canadians?” asked Vera Hassner Sharav, president of the Alliance for Human Research Protection, a non-profit group based in New York. “If you’ve got these deaths and strokes, even in children, who generally don’t get heart attacks and strokes, you should pull the drug off the market until the manufacturer can prove it’s safe.”

Feb 3, 2005: Suicide Rate Down in the Era of Prozac – LA Times

But Vera Sharav, president of the Alliance for Human Research Protection, said the conclusions of the analysis might not be valid because the decline could just as easily be explained by laws introduced around the same time reducing access to firearms – a common means of committing suicide.

Feb 3, 2005: Antidepressant warnings make experts nervous – San Antonio Express-News

In comments on Tuesday, Vera Hassner Sharav, a sharp critic of FDA regulators and drug companies and president of the New York-based Alliance for Human Research Protection, called Licinio’s causal connection between antidepressants and falling suicide rates “fallacious” and urged the drugs be used as a “last resort.”

” If you examine the Brady Bill (on handgun control) and when it was enacted (1993) with the restrictions on firearms, that’s when you see the reduction in homicides and suicides,” she said.

Feb 2, 2005: Fewer Kids Prescribed Drugs for Depression – Sharp Decrease Seen After Reports of Risks – Washington Post

“When parents and physicians were kept in the dark about the scientific evidence, they trusted the drug advertisements that promised wonderful results with no risk,” said Vera Hassner Sharav, founder of the Alliance for Human Research Protection, a patients’ rights organization.

“When given an opportunity to weigh the risks and benefits after learning the facts, parents are making responsible choices for their children,” she said. “They are being cautious and skeptical, as they should be.”

Jan 24, 2005: Sometimes the drugs designed to help people battling depression do more harm than good – News Tribune

Re SSRI induced akathisia: “People cannot take it and will do anything to make it stop,” said Vera Sharav, a patient safety advocate who heads the Manhattan-based Alliance for Human Research Protection.

Jul 21, 2004: Hearing on Antidepressants Canceled – Washington Post

AHRP President Vera Sharav quoted re Rep Greenwood’s retirement & job offer from Biotechnology Industry Organization

Jun 21, 2004: Antidepressants – USA Today Editorial / AHRP OpEd/ WSJ Editorial Bashes Spitzer

USA Today Invited OpEd by AHRP

Jun 14, 2004: Guardian Reports: MHRA to Issue New SSRI Restrictions

Vera Sharav of AHRP quoted in the Guardian: “Given the concern about evidence of a suicide link to Prozac and the other antidepressants, it is an affront to the public that the MHRA would even consider approving Prozac for children.”

January 9, 2003

A cover story interview with AHRP Board member, Dr. Loren Mosher, appeared in the January 9 issue of San Diego Reader. Still Crazy After All These Years by Jeannette De Wyze vol. 32, no. 2, p. 26 et. Seq.

November 30, 2002

The Washington Post. Artificial Heart Implant Leads to Suit Over Consent Process by Debbie Goldberg. p. A-3 “Vera Hassner Sharav, president of the New York-based Alliance for Human Research Protection, said the informed-consent process for many trials is a sham. Clinical trials are “set up in such a way that patients are misinformed and misled,” she said. “Patients and families are not told what the actual and foreseeable risks are, and what they may expect in the way of pain and suffering.”

Oct. 4, 2002

Boston Globe. Institute of Medicine worries that public trust is threatened by deaths. By Michael Kranish and Alice Dembner.

The IOM report did not satisfy some longtime observers. ”The IOM committee, headed by a Harvard University dean, disingenuously recommended entrusting `the responsibility for ensuring that protective rules are followed’ to `the leadership of the organization doing the study,’ Vera Hassner Sharav, president of the Alliance for Human Research Protection, said in a statement. ”That is an example of conflicts of interest.”

George Annas, chairman of the health law department at Boston University’s School of Public Health, said ”We need a lot more reform than the IOM seems to recognize. This is but another voice crying in the wilderness. All their major recommendations have been made over and over again.”

September 5, 2002

Do the Ends Justify the Means in Human Research?

Aug. 20, 2002

Medical Science Violating Children – 450 healthy children targeted – redflagsweekly

Aug. 7, 2002

Los Angeles Times

Some partient advocates are suspicious. “This is like a grab for more power” by UC, said Vera Hassner Sharav, president of the Alliance for Human Research Protection. “In fact, they haven’t earned it at all. They haven’t complied with the existing regulations and law.” She and other critics said the UC system has a history of violating the rights of patients involved in research.

http://www.latimes.com/features/health/medicine/la-me-uc7aug07.story?coll=la%2Dhealth%2Dmedicine

Aug. 5, 2002

San Francisco Chronicle

“Though critics find flaws with both oversight systems, they say it’s the university professors, not the industry profit-seekers, who have more lax rules on human safety.”

“Academics don’t have to meet a payroll or meet a bottom line, so they’re removed from real responsibility, said Vera Hassner Sharav, an East Coast activist who helped expose the UCSF experiment.”

http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2002/08/05/MN47420.DTL

July 29, 2002

San Francisco Chronicle

"Vera Sharav of the Alliance for Human Research Protection based in New York said the UCSF violations show that informal methods of proxy consent are prone to abuse. ‘I think it demonstrates why you must not have this back-door approval process,’ Sharav said. ‘It invites exploitation of incapacitated people.’"

University of California, San Francisco: Patients Rights Violated

May 27, 2002

Redflaggsweekly

PRESCRIBING UNTESTED DRUGS TO CHILDREN

By Nicholas Regush

According to Vera Hassner Sharav of the Alliance for Human Research Protection, the 1997 federal rule should have required the FDA or the Department of Health and Human Services to conduct an impact study "to determine whether, and how, children would be affected adversely" by entering clinical drug tests. Hassner says that, "It is most disturbing that neither the administration nor Congress has seen fit to request an annual report detailing information about pediatric research in order to ensure that children are not being harmed or exploited. Congress does mandate detailed annual reports about the conduct of animal research. Animals are protected under the Animal Welfare Act of 1966; children who are recruited into clinical trials – with cash payments to parents – are unprotected." http://www.redflagsweekly.com/regush/untested_drugs.html

March 20, 2002

The Boston Globe.

FDA Rule Changes: Benefits, Dangers.

By Jeffrey Krasner,

Vera Hassner Sharav, president of the Alliance for Human Research Protection, a nonprofit that seeks to prevent dangerous drugs from hurting people during and after development, said the effort highlights deficiencies in testing before drugs are approved.

”They’re speeding up the drug approval process knowing that there may be some safety hazards, and so they’re post-facto allowing for some tracking of hazards that are likely to follow,” she said. ”They’re pretty much expecting problems because drugs are being approved too quickly.”

Another potentially divisive issue is a new rule under which the FDA could use outside experts to help it review the design of a company’s clinical trials. The company could provide a list of experts for the agency to choose from.
http://www.annieappleseedproject.org/fdarulchanbe.html

March 11, 2002.

American Medical Association News:

Victoria Stagg Elliott

"If the NIH would fund more studies untainted by industry influence, we are likely to find out that other ‘disorders’ are not valid either," said Vera Hassner Sharav, president of the Alliance for Human Research Protection. http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsc0311.htm

2002: National Center for Dissemination of Disability Research,

Research Exchange: Volume 7, Number 1.

What Do Professional and Consumer Organizations Have to Say?

AHRP is the first organization listed, our mission statement posted. http://www.ncddr.org/du/researchexchange/v07n01/7c_consumersay.html

January 27, 2002

The Baltimore Sun

Death in test haunts Hopkins researcher By Tom Pelton

Scientist: Friends say the doctor nearly quit after a fatal experiment but hopes to get back to healing. "Vera Hassner Sharav, president of the Alliance for Human Research Protection, which is based in New York, said there is no excuse to let researchers experiment on people and then not hold them accountable when they fail to take action to avoid tragedies." http://www.sunspot.net/news/health/bal-te.md.togias27jan27.story?coll=bal%2Dhome%2Dheadlines

January 12, 2002

The Washington Post.

A Death During Research By Susan Okie

Although OHRP officials apparently knew of her death while investigating the Hopkins case last summer, university and hospital officials did not publicly announce that a volunteer had died in the Cleveland study until December. In the preceding month, OHRP informed officials at the two institutions that it had found "no evidence to substantiate" concerns that researchers had failed to minimize the risks to participants. Holden-Able’s death was first reported in December by the Cleveland Plain Dealer.

"OHRP knew about it. Nobody was told anything," said Vera Hassner Sharav, president of the Alliance for Human Research Protection. "Now they’re saying, ‘Oh, but everything is fine.’ The major issues are left out." Posted by PHARMACY FORUM. http://www.pharmacyforum.com/Jan2002Articles/a_death_during_research.htm

December 30, 2001

The Washington Post Magazine.

Informed Consent By Jennifer Washburn

The drive to speed up clinical trials has induced many companies to "replace careful patient screening practices with a crude reward system," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, a nonprofit group based in New York. Industry now commonly pays doctors financial incentives ranging from $1,000 to $6,000 for each new patient recruited; top recruiters earn somewhere between $500,000 and $1 million a year. http://www.washingtonpost.com/wp-dyn/articles/A14726-2001Dec21.html

December 20, 2001.

THE BOSTON GLOBE.

Pediatric testing program extended By Alice Dembner

”Congress should have imposed mandatory monitoring of pediatric trials, including unannounced inspections,” said Vera Sharav, president of the Alliance for Human Research Protection. ”The extension of this legislation is a bonanza for the drug industry, and in some cases it may be a real threat to children’s health.” http://www.boston.com/dailyglobe2/354/nation/Pediatric_testing_program_extended+.shtml

December 3, 2001

NEW YORK POST

STUDIES ON RITALIN ARE CHILD ABUSE By Douglas Montero

"They want to see how much these children can tolerate," said Vera Hassner Sharav, who heads the New York-based Alliance for Human Research Protection. "The research is absolutely child abuse." http://www.nypost.com/cgi-bin/printfriendly.pl

November 13, 2001

The Washington Post.

Johns Hopkins Faults Researcher in Human Drug Trial. By Shankar Vedantam

Vera Hassner Sharav, president of the patient advocacy group Alliance for Human Research Protections, said the university report ignored the institution’s own role in permitting the research. She called for an independent investigation. "Internal self-investigation and self-regulation does not work," she said. "The public trust will not be restored with this kind of self-serving finding." http://www.washingtonpost.com/wp-dyn/articles/A18596-2001Nov12.html

October 27, 2001

Daily Record.

Risk, research and the ripple effect By JOE SURKIEWICZ

"It’s a landmark decision," said Howard Fishman, a member of the steering committee of the Alliance for Human Research Protection, a self-funded advocacy group concerned with protecting the rights of human research participants and the director of continuing medical education at Harvard Medical School. "Much to my relief, the court has intervened with a broad and sweeping statement of ethical requirements."

"It’s generally believed that medical science is an unalloyed boon to mankind, and we tend not to be skeptical of medical research."

Yet history shows that science is "ethically neutral" and gives "little consideration" to the application of new knowledge,

the Court of Appeals addressed head-on, Fishman said: "The Johns Hopkins IRB became accomplices to the researchers with the intent of circumventing ethical standards."

For a fuller understanding of the ethical debates over human-subject research, Fishman suggested following the "money trail."

"Federal funding and research funding by major pharmaceutical manufacturers determine the research agenda," Fishman said. "Major academic institutions have found themselves to be dependent on these funding streams.

Particularly in this era of deconstructionism [a term Fishman defined as the perceived right to reinterpret the author’s original intent], moral relativism and muticulturalism," he said, "it’s easy for institutional stakeholders’ to succumb to the temptation to blur ethical rules.

"One sees repeatedly an effort to obfuscate facts and the use of rhetorical devices to justify otherwise unacceptable procedures," he added.

An example: "Kennedy Krieger seems to suggest the risks to medical research are analogous to the everyday risks of life," Fishman said. "These kinds of statements raise our concern that research institutions view ethical

safeguards as inconveniences that should be circumvented."

Fishman praised the Court of Appeals for another aspect of its August opinion. "A related concern expressed by the court is the need to provide protection Îspecifically for the poor and less educated who bear most of the

research burden,’" Fishman said, quoting the opinion. "Research harms are visited disproportionately on poor and minority children."

http://www.mddailyrecord.com/cgi-bin/udt/im.print.story?client=dailyrecord&storyid=60140

Oct. 8, 2001

American Medical Association News.

Ruling Bans Research Where Children Are At "Any Risk." By Andis Robeznieks

Just as the institute has its allies, the other side has its supporters as well – including Vera Hassner Sharav with the Alliance for Human Research Protection, who hailed the appellate court’s decision. "The Maryland court opinion is a powerful reaffirmation of the rights of children not to be exploited as laboratory animals." http://www.ama-assn.org/sci-pubs/amnews/pick_01/prsd1008.htm

September 20, 2001

THE BALTIMORE SUN.

Lead paint rule could limit research in Md. By Tom Pelton

Vera Sharav, president of the New York-based Alliance for Human Research Protection, said it’s important that the court’s decision remain in place. "The court opinion is a powerful reaffirmation of the rights of children not to be exploited as laboratory animals," said Sharav. http://www.sunspot.net/news/local/bal-md.research20sep20.story?coll=bal%2Dlocal%2Dheadlines

September 8, 2001.

IHF: Institute for Health FREEDOM.

Federal Research "Protections" Committee Recommends Waiving Parental Consent Before Enrolling Teenagers in Drug Trials.


"One member of the NHRPAC working group opposed waiving parental consent. Vera Sharav of the Alliance for Human Research Protection asked, "What happens when a child is harmed? Do you bring the parent back [into the decision-making process]?" It’s also important to consider whether teenagers really understand the future implications of sharing their genetic information for research purposes and whether they are capable of deciding the risks versus benefits of enrolling in genetic-based studies." http://forhealthfreedom.org/Publications/Children/TeenDrugTrials.html

August 28, 2001

ASSOCIATED PRESS.

Johns Hopkins Under Fire Over Ethics. By JOHN BIEMER

"It’s unfortunate that the premier medical research institute in the U.S. has all of these problems conducting basic peer review and review of the ethical component of the research it’s conducting," said John H. Noble, a Catholic University health policy professor and member of the Alliance for Human Research Protection. "We need checks and balances, and that’s the fundamental flaw in the system."

Noble said the review boards are not just stretched thin, but also suffer conflicts of interest rooted in doing "business as sub-units of the very institution that gets them funded." The review boards may even rubber-stamp approval if a researcher’s reputation is well-established, he said. http://news.excite.com/news/ap/010828/16/hopkins-struggles

August 24, 2001

THE WASHINGTON POST.

‘MY KIDS WERE USED AS GUINEA PIGS’ By Manuel Roig-Franzia

"There is a culture that has grown up among researchers; it puts science
above human beings — and that’s a very dangerous thing," said Vera Hassner
Sharav, of the Alliance for Human Research Protection, a privately funded
New York advocacy group.
http://www.washingtonpost.com/wp-dyn/articles/A59479-2001Aug24.html

August 20, 2001

The Scientist 15[16]:20, Aug. 20, 2001

     

NEWS

News Notes

   

New Panel to Police Human Research By Bob Roehr

A group of patient and social justice advocates plan to form an Alliance for Human Research Protection to provide oversight on clinical research from laypersons’ point of view, says John H. Noble Jr., a founder and professor of social justice at the Catholic University of America. He lambastes internal review boards (IRBs) designed to protect human subjects as agents of institutions "who are hustling the bucks" from industry and other sources. Noble says IRBs need to be "severed from research institutions" and provided adequate resources as part of the accepted overhead costs of conducting clinical trials. Government commitment to patient protection "without the [funding] is just a sham," he says. Greg Koski, director of the federal Office of Human Research Protections (OHRP), which grants authority to the IRBs, acknowledges that concern over IRB members’ financial ties to industry can be valid. "But I don’t think it’s fair to call [the system] a sham," he says. "While there are legitimate reasons to be concerned about conflicts, it’s also fair to say institutions have an interest in making sure things are done right. We have to work toward ensuring that conflicts do not exist." Koski says he welcomes the creation of any group that broadens public participation in and understanding of research oversight. Comprising lay people, researchers, and ethicists, the alliance would have no regulatory authority, but its founders aim to use public censure to help enforce legal guidelines.

July 31, 2001.

Washington Post.

FDA Urged to Broaden Study Rules By Susan Okie

Waiving parental consent for research participation could subject children to increased risks, said Vera H. Sharav of the Alliance for Human Research Protection. "Why is there such a rush to accommodate research by diminishing the protections that children now have?" asked Sharav, a member of the NHRPAC working group who dissented from the majority position. http://www.washingtonpost.com/wp-dyn/articles/A8479-2001Jul30.html

July 20, 2001

WebMD.

Johns Hopkins Works to Repair Patient Safety Problems:

Patient’s Death Led to Shutdown of Human Experiments.

By Jeff Levine

Vera Hassner Sharav, president of the Alliance for Human Research Protections, a New York-based advocacy group, says the message is that it’s time for a tougher approach to ensuring patient safety. "There’s no incentive [for research institutions] to comply with safety requirements, because we don’t have the legal restraints. We don’t have the independent oversight to make sure that these rules are enforced," Sharav tells WebMD. http://webmd.lycos.com/content/article/1728.84413

July 20, 2001 

THE WASHINTON POST.

Johns Hopkins Halts ALL Medical Volunteer Trials – What Can We Learn From This Tragedy? By Susan Levine and Rick Weiss

The action against Hopkins, said Vera Hassner Sharav, of the Alliance for Human Research Protections in New York, "shows that this is not about an individual aberrant researcher that violated research rules, but about institutional shortcomings. The system is not working if you actually have to shut down an entire research center."

In fact, just two years ago, the HHS inspector general released a report that warned of an imminent breakdown in the nation’s system for overseeing the safety of research participants. In particular, it found that universities’ and medical centers’ institutional review boards, which judge the scientific and ethical merit of human research studies, are severely overburdened, staffed by insufficiently trained people and open to conflicts of interest — all problems raised in the Hopkins closure. http://www.washingtonpost.com/wp-dyn/articles/A23208-2001Jul19.html

Prior to July 15, 2001, Vera Hassner Sharav headed Circare (Citizens for Responsible Care and Reasearch), on whose behalf she spoke, testified, and issued "Veracare Infomails" (news clippings) via e-mail to a wide audience.

June 25, 2001.

THE NEW YORK POST.

ELECTROSHOCK TURNS HILLSIDE TO HELLSIDE By Douglas Montero

A WATCHDOG group says mental patients at Hillside Hospital in Queens are being abused – mentally.
Vera Hassner-Sharav, the president of the city’s Citizens for Responsible Care and Research, called the alleged coercion practice at Hillside "unconscionable."

She said the only recognized use of electroshock is for patients with severe clinical depression who haven’t responded to any other form of treatment.

Zapping Nina Hernandez, who doesn’t suffer from depression, is "contrary to accepted medical standards put forth by the American Psychiatric Association" and, therefore, "that makes it experimental," Hassner-Sharav said.
http://www.nypost.com/commentary/33318.htm

June 21, 2001

NATURE

Asthma Study Death Spurs Inquiry. BY Paul Smaglick,

"The exploratory focus of the asthma experiment has already attracted criticism. Vera Sharav, President of the New York based Citizens for Responsible Care, calls it "a fishing expedition" best reserved for animals, not people. "People should be protected from this kind of experiment," she said." http://www.nature.com/cgi-taf/DynaPage.taf?file=/nature/journal/v411/n6840/full/411873b0_fs.html

March 20, 2001

The Boston Globe

Researchers’ Use of Questionable Tactics to Attract Children into Medical Studies on the Rise. By Alice Dembner

Patient advocates and ethicists have also challenged a study at Yale involving a population whose majority is healthy children and adults. The study is designed to test whether the potent antipsychotic drug Zyprexa can prevent schizophrenia. The crux of the problem in this case deals with the ethicality of exposing normal, healthy children and adults to the potential dangers and side effects of the powerful drug. The study is sponsored in part by Eli Lilly, which through Zyprexa earned more than $2 billion in revenue last year.

Speaking to the Yale case, Vera H. Sharav, president of Citizens for Responsible Care & Research, is quoted by The Globe as asserting that, "A clinical trial involves risk and, if a child doesn’t have a condition, they shouldn’t be put at risk just because they’re helpless and accessible The biggest question is whose children are being sought as subjects.  Do those who profit from research volunteer their own children?" http://hsc.unm.edu/resp/news_children.html

March 2, 2001

Salon.com.

Your heart has been recalled: In the brave new world of body-part implants, what happens when you get a lemon of a ticker? By Dawn MacKeen

"What we’re seeing is that harmful products, be they drugs or devices, are being approved, and then introduced into unwitting people who think they have been thoroughly tested for their safety when obviously they have not," says Vera Sharav, president of Citizens for Responsible Care (CIRCARE), a human rights organization. http://www.salon.com/mwt/feature/2001/03/02/body_parts/index.html

March 2001

CBS News / HeathWatch.

Scientific Study? No One Told Me" By Eric Sabo

"Patients are being encouraged to enter clinical trials with false promises of access to ‘cutting edge, free treatment,’" claims Vera Sharav of Citizens for Responsible Care & Research. "Physicians are earning more money recruiting their patients for clinical trials than treating them with proven treatments."

Informed consent remains the Miranda rule for those entering a clinical trial: Researchers must explain the reasonable benefits and risks that subjects can expect from participating. But how good is this information, and do patients really understand what they’re getting into?

..In fact, withholding relevant information from study volunteers is a major source of trouble. Documents from the National Institutes of Health show that informed-consent problems accounted for 34% of government crackdowns on clinical trials over the past 10 years, making this the second leading reason why researchers were cited for violations. A similar pattern of bad advice is also alleged in several recent lawsuits. http://cbsnews.com/now/story/0,1597,282816-412,00.shtml ;

November 7, 2000

THE WASHINGTON POST

Child Research Study Halted By Rick Weiss

Vera Hassner Sharav,

president of Citizens for Responsible Care & Research, a New York-based human subjects advocacy group, said the experiment was just one of a growing number of inappropriate studies involving healthy children.

"There’s a feeding frenzy for children in research now," Sharav said. "And now the federal government has contributed to the erosion of research ethics by giving its seal of approval to experiments that inflict pain on helpless children and by putting them in harm’s way." http://washingtonpost.com/wp-dyn/articles/A27805-2000Nov6.html

July 25, 2000

Washington FAX

FASEB working with AAU, AAMC on protection of human subjects in research

By Vincent J. Swanson

AAU recommendations don’t get to the heart of the problem, say patient advocates

although academics appear ready to improve their protection of human subjects, some patient advocacy groups say the self-regulatory aspect of human subjects research–the Institutional Review Boards–is the central flaw in the system. They would prefer to see external overseers, contending AAU’s recommendations and even congressional proposals fail to fully protect human subjects.

"The only gate-keepers safe guarding human subjects are the IRB’s, and IRB’s are all in the pockets of special-interests," said Vera Sharav, president of Citizens for Responsible Care and Research (CIRCARE), a group advocating for human subjects’ rights. "Human subjects research is a two-tier system," she told Washington Fax. "Those conducting the research and the subjects who are participating in the trials. No one is protecting the subjects."

Sharav also asserted that most of the human subjects in research are low-income and have no access to health insurance. "The conflict of interest in research is overwhelming," she explained, "IRBs are groups of an elite class of academicians who have vested interests, and the research is being conducted on an underclass." Without oversight by the Inspector General, "there will be no safety in research," Sharav argues.

Sharav has been vocal on the issue of patient’s rights since 1993. Sharav has testified several times and appeared before the National Bioethics Advisory Commission in 1997.

"We are not anti-science," she told Washington Fax. "We want human subject trials to continue, but, we want more disclosure on the adverse effects of trials." http://www.washingtonfax.com/samples/2000/20000725.html

January 31, 2000.

The Washington Post.

Earlier Gene Test Deaths Not Reported NIH Was Unaware Of ‘Adverse Events’

By Deborah Nelson and Rick Weiss

"You have to find out what it is before you can rule out what it’s not. That’s

just logic," said Vera Hassner Sharav of Citizens for Responsible Care and

Research in New York. "Otherwise it’s basically a denial of responsibility."

http://www.unmc.edu/irb/news/Washington%20Post%20re%20gene%20therapy%20deaths%20(1-31-00).txt

May 12, 1999

ABC News.

Risky Research Duke Suspension Sheds Light on Bigger Problems

By Jonathan Dube

Hamsters Yes, Humans No
Vera Sharav,
the director of Citizens for Responsible Care and Research, a New York City-based advocacy group, says that the safeguards in place for clinical trials involving animals are better than those for human subjects.
    
"No one knows how many humans have been harmed by trials, or even how many people are in clinical trials," Sharav says. "Yet if you want to know the number of hamsters in clinical trials between June and December, you can get a very detailed printout."
     Sharav also echoes the DHHS complaint that the institutional review panels, which consist mainly of university officials and researchers evaluating the work of their peers, face potential conflicts of interest.
     "It’s a community that has an interest in the research and in the research dollars continuing to flow," Sharav says. "No one on the boards looks out for the interests of the patients. http://abcnews.go.com/sections/living/DailyNews/duke_irbs990512.html

May 12, 1999

The Washington Post.

U.S. Halts Human Research at Duke By Rick Weiss

Historically, it has not been unusual for the OPRR to exchange letters with research centers for three to five years until problems are resolved, said Vera Sharav, head of Citizens for Responsible Care and Research, a New York City-based advocacy group. Nonetheless, if the OPRR’s vigor is representative of a new, more aggressive attitude by the agency, including cracking down on bureaucratic lapses as well as on frank abuses of patients, then citizens can only benefit, Sharav said. "If no one does anything," she said, "then the violations get greater." http://www.washingtonpost.com/wp-srv/national/daily/may99/duke12.htm

April 22, 1999

The Los Angeles Times.

Feds crack down on drug facilities’ research in L.A. By Terence Monmaney

The recent actions represent a growing awareness that "researchers working with vulnerable populations do not always adhere to requirements for overseeing the well being of human subjects," said Vera Hassner Sharav, head of Citizens for Responsible Care and Research, a New York City-based advocacy group. "Vulnerable populations are at risk of having their conditions worsened in order to afford researchers the opportunity to study their illnesses." http://voice.bloomu.edu/4-22-1999/Nation-World/Nation-World2.html

February 26, 1999

THE BOSTON GLOBE.

Mental illness studies checked: Policy group weighs formal review of several practices By Dolores Kong

The Institute of Medicine, a leading US health policy group, is seriously considering launching a review of studies that induce psychotic symptoms or that withdraw medication from people with mental illness, a top official said yesterday.

”It’s something we are very interested in trying to be helpful on,” said Susanne Stoiber, executive officer of the private nonprofit institute, created to serve as a health policy adviser under a congressional charter granted to the National Academy of Sciences.

The institute’s interest coincides with a recommendation that the institute review the studies, made in November by a presidentially appointed bioethics commission. In making that recommendation, the commission cited a Globe series highlighting the ethical concerns raised by the research.

But some critics of the research questioned whether the institute is the right organization to review the psychosis-inducing and medication-withdrawal studies.

”It can’t in any way be even a semblance of independent investigation,” said Vera Hassner Sharav, president and co-founder of the Citizens for Care in Psychiatry and Research, a leading critic of such studies. ”That is so cynical. The very people who conduct these kinds of illness-exacerbation experiments are members of the IOM.” http://caringonline.com/eatdis/misc/mntlillness.htm

February 2, 1999

The Boston Globe

Study harmed mentally ill, agency reports By Dolores Kong

The agency found that while that study, published in 1987, resulted in no long-term adverse effects, people ”suffered at least some short-term harm or discomfort as evidenced by documentation of schizophrenia relapse in all 28 patients.”

For instance, one of the patients in that study, after being off medication for four weeks, ”became violent and struck a doctor. Another patient … expressed suicidal ideation; and another patient’s symptoms worsened significantly after only one day of being off medication,” according to the agency, citing documents it reviewed as part of its investigation.

The agency’s finding comes five years after a New York-based mental health advocate first filed a complaint with the agency about the 1987 study and raised concerns in the media.

”I really am questioning why it took them so long. What kind of obstacles were there that prevented them from investigating it and determining it sooner?” said Vera Hassner Sharav, president and co-founder of Citizens for Responsible Care in Psychiatry and Research. http://www.kersur.net/~mhci/studyharmed.html

 

Jan 22, 1999

SCIENCE

Volume 283, Number 5401, pp. 464 – 465

BIOETHICS: NIMH to Screen Studies for Science and Human Risks

Eliot Marshall

link to text of article

For more than a year, patient activists and ethicists have been calling for a revolution in the way clinical studies in psychiatry are monitored. They argue that studies of psychiatric disorders, especially trials that exacerbate symptoms or withdraw medication, expose subjects to needless risks. And they have been demanding a more critical, independent review of protocols. These ideas have circulated widely in the press and dominated the work of a national bioethics commission in 1998.