False positive HIV test results in the news

Posted by Editor on August 30, 2004

There have been several stories where "false positive HIV test results" have been surfacing. First is a story about HIV tests that have a high number of false positive test results. The US government will be using them.

Next is the story of a California man sentenced to death with a "false positive" HIV test result and toxic AIDS meds.

A young man in India with a positive test result that nearly ruined his life. June 2004.

Here is a letter demanding accountability for tests that continually react as "HIV positive," statistics that make no sense and years of wasteful government spending in the name of AIDS. From Michael Wright.

Maryland General Hospital has been accused of sending out hundreds of inaccurate test results for hepatitis and HIV, and a woman is suing for negligence.

Here is a letter to doctors from Ortho Clinical Diagnostics explaining that the HIV test currently on the market is causing too many false positives. From December 23, 2003.

Here is the sad story of someone who was told he was HIV positive, took the drugs for years, only to dicover that he wasn't HIV positive after all. August 27, 2004. From The San Francisco Chronicle.

False diagnosis of HIV discovered after 8 years
Veteran's life severely affected after VA doctor made mistake

For eight years, Hayward resident Jim Malone attended biweekly counseling sessions for men living with HIV. His rent was paid in part by a county health program. Project Open Hand delivered free meals. A nurse visited him at home every two weeks.

He lost weight, grew depressed and thought the end was near each time he caught a cold. He had been told in 1996 that he was HIV positive.

Earlier this month, Malone, 59, was summoned to his doctor's office. He listened as the doctor delivered the stunning news: He is HIV negative. The doctor acknowledged the error, writing in a letter dated Aug. 4: "As his primary care provider, I take full responsibility."

"He told me, 'We made a very big mistake. We did not do our job,' " said Malone, who is gay and has lost friends to AIDS. "I said, 'You mean to tell me that all you have to say is you are sorry? Sorry that I lived for all this time believing I was going to die?' "

Malone says he is relieved but angry. He lived for a long time with a disease he didn't have. Family relationships that had been strained were severed after his diagnosis. Romance became a thing of the past. Planning for the future seemed pointless. The array of services he received for free could have gone to someone else.

His misdiagnosis is rare but undisputed and shows the far-reaching damage wrought by medical mistakes and the potential for flaws in burdened health care systems.

Officials at the Oakland Department of Veterans Affairs' outpatient clinic where he was treated admit the mistake and have launched an investigation into what went wrong and how the error was perpetuated year after year. VA officials were taken by surprise by the Aug. 4 letter in which the doctor accepted blame and admitted the error. Malone's physician, Dr. Richard Karp, was not available for comment as the case is under investigation.

Karen Pridmore, a spokeswoman for VA's Northern California Health Care System, which has eight clinics and a medical center and serves more than 65,000 patients, said Malone had arrived at the clinic in 1996 with lab results from an outside testing firm in Southern California. Those results showed he was HIV positive. The VA did its own confirmatory HIV test on Malone and found he was negative.

"It appears he was never informed of the negative result," Pridmore said last week. Malone was not placed on AIDS medication because his routinely tested blood work was fine.

"An HIV positive person can have good T-cell counts and undetectable viral loads over a long period of time," Pridmore said. "And in this case, the patient exhibited symptoms that could be consistent with an HIV diagnosis."

The VA's mistake came to light thanks to the health care system's internal software program, which tracks its HIV patients and conducts a periodic review of cases. It had done its job and raised a red flag, but the computer's human handler's apparently failed their job: For eight years, the life-changing results showing Malone is HIV negative were never relayed.

Malone, who has been on disability since 1984, when he ruptured two disks in his back while at work, has myriad health problems including heart disease and scoliosis.

In a Sept. 2003 letter from Karp, Malone was classified as "permanently disabled and unable to work or participate in any stressful situation whatsoever." His medical prognosis was deemed "very poor." The letter said Malone was being treated for 20 medical conditions, the first condition being HIV. The sixth item on the list, nausea and vomiting, was said to be "related to condition 1."

Malone, who is thin and voluble and walks with a cane, said that he attributed his frequent nausea, vomiting, diarrhea and weight loss to being HIV positive.

"When I wasn't able to eat, when I was sick, my in-home health care nurse would say, 'Well, Jim, it goes with your condition.' That's the way I thought," said Malone, who feared when he learned he is HIV negative that he would be charged with fraud.

In response to his fear, Karp wrote the exculpatory Aug. 4 letter. He said that his patient should not be held responsible for services rendered by county health agencies and local nonprofit groups.

"He naturally sought funds and services available to HIV patients," Karp wrote. "Mr. Malone should, in no way, be responsible for falsely receiving these benefits or services because he had been told for years he was positive for HIV."

Malone said none of the agencies that served him has asked for reimbursement.

A Hayward resident for most of his life, Malone was in the first graduating class of Mount Eden High School. Upon graduation, he enlisted in the Army and served for three years as a clerk typist in Germany.

When he returned home in the late 1960s, he landed a job as an ambulance driver. After 17 years in the business, he went to work for a mortuary company, where he injured his back.

To please his family, he said, he lived a kind of double life. He was married for nearly seven years and has a daughter who is now 34 and a granddaughter who will be 13 in October.

"The social norm at the time said that if you get married and have children, being gay will go away," Malone said. "Well, it didn't go away. It doesn't go away."

Malone said he had grown more confident over the years with his sexuality and now proudly displays a rainbow flag in the window of his home.

His recent painful life lesson has a practical side, he noted. "I would tell people to get not just one HIV test, but multiple tests," he said. "I would say test, test and retest."

Dr. John Stansell, professor of medicine at UCSF and medical director of HIV programs at San Francisco General Hospital, called false positive tests "extraordinarily rare."

Since 1984, standard screening for HIV has included both the so-called Elisa and Western Blot tests. If done together, as is customary, the results are nearly infallible.

"If a person only got the Elisa, and it wasn't followed up with the Western Blot, there is a small and I emphasize small chance you could have a false positive," Stansell said. While it's always acceptable to ask for a second test, he said, false results for tests done correctly are remote.

"Even the new tests, the one that use saliva, or a drop of blood, have a very high sensitivity," Stansell said. "You should confirm those, but in all likelihood, they are accurate."

Dr. Jon Green, chief of infectious diseases at VA Northern California, also noted the reliability of the tests. He added, however, that mistakes can happen through handing and reporting.

"Everyone has to be on their best guard to check their work in this area," Green said.

VA spokeswoman Pridmore added that Malone's case was "very isolated."

Similar cases are being played out in courts across the country.

This month, a Maryland woman sued a local hospital for her false-positive HIV diagnosis. She believed for eight months that she was HIV positive and is seeking $2 million in damages.

In 2002, a man who was wrongfully told he was infected with HIV won a $1.4 million judgment from a county health department in Oklahoma County. The man said he suffered severe emotional distress as a result of the health department's negligence. He lived for four years believing he was HIV positive.

Malone has retained an attorney and expects to file a malpractice claim against the VA Health Care System.

'Flawed' HIV diagnosis nearly kills youth
TIMES NEWS NETWORK
MONDAY, JUNE 07, 2004

FARIDKOT: It's a scandal that's going to make anyone's blood boil. Call it a fall from grace or a disgraceful misdiagnosis by a doctor here, Jasvir Singh's life, as he knew it, was changed utterly when he was wrongly diagnosed a HIV positive patient at Chandigarh Clinical Laboratory here a little over a month ago.

On April 23, Jasvir had gone to Guru Gobind Singh Medical College and Hospital here as he was having some skin problem. The doctor at the hospital advised blood tests.

Jasvir got his tests done from Chandigarh Clinical Laboratory here. One of the blood reports found him to be HIV positive. Soon after the scandalous revelation, he became a social pariah, his engagement collpased (he was to get married two months later) and his mother Gurdial Kaur had a heart attack and was hospitalised.

The trauma overwhelmed Jasvir so much that he even tried to commit suicide. After more than two weeks of relentless mental torture, Jasvir decided to seek a second opinion. On May 15, he went to Guru Gobind Singh Medical College and Hospital for re-examination of his blood.

Much to his relief, the blood tests at the medical college found him HIV negative.

To be 100 per cent sure, Jasvir sought a third opinion and got himself examined from Arashdeep Laboratory at Amritsar. This test also declared him HIV negative.

Another sharp U-turn in Jasvir's fortunes, this time for better. But for Jasvir, the news of his innocence has come much too late in the day. He has sought legal action against Dr Adarsh Kumar of Chandigarh Clinical Laboratory for damaging his social and family life.

Dr Adarsh is, however, unfazed. He sees a conspiracy of his business rivals in the allegations of Jasvir Singh.

The doctor said that Jasvir Singh and his brother (who works in the police department) wanted to blackmail him and when he declined to succumb to their tactics, Jasvir threatened legal action.

In his defence, Dr Adarsh said that only preliminary test for HIV are conducted at his laboratory and these are never conclusive as two more test are required for a final diagnosis.

May 13, 2004
GAO FraudNET
441 G Street NW
Washington, D.C. 20548
Dear General Accounting Office Officials:

In the 90s I was awarded two federal grants for AIDS/HIV research projects.  These came from the Small Business Innovation Research Program of the National Cancer Institute. This AP story is one of many documents which confirm my experience in this regard:

http://www.aegis.com/news/ap/1995/AP950317.html

By the end of the project I was thoroughly disillusioned with the AIDS program.  It is based upon very flawed science and its public support rests on an entrenched program of disinformation.  There was an award-winning expose of this by The Wall Street Journal in 1996, but the article did not probe deeply enough into the issues and does not appear to have achieved any concrete results in terms of policy changes:

http://www.pulitzer.org/year/1997/national-reporting/works/2.html

I'll describe an example of disinformation and waste here in Oklahoma.  For several years, Planned Parenthood of Central Oklahoma has been distributing a brochure with the deceitful claim that there are between 1 and 2 million HIV-infected persons in the U.S.   There was never any justification for this estimate.  The current official estimate is between 850,000 and 950,000.  Most likely this Planned Parenthood brochure is produced with the support of AIDS funds originating with the CDC and distributed to local organizations by state health departments.

The testing procedure which supposedly identifies HIV antibodies is non-specific and yields an unacceptably high number of false positive results.  Here is a bibliography of scientific articles reporting dozens of factors known to trigger false positives:

http://www.virusmyth.net/aids/data/cjtestfp.htm

In October 1987, Dr. Stephen Pauker of the New England Medical Center in Boston gave Congressional testimony about the risk of false positive HIV test results. He testified:

We come here before you today to argue against the widespread use of serologic tests for evidence of HIV infection in so-called low-risk populations. We firmly believe that widespread screening for such infection, as has been proposed for immigrants, marriage license applicants, and, at least in one state, members of the general population, is unwise; it may in fact lead to a social catastrophe.

Dr. Pauker used the example of Peoria, a community he expected to have a true HIV prevalence of only 1 infection per 10,000 persons. After studying various laboratory proficiency studies, he and his colleagues concluded that the false positive rate for the ELISA/Western Blot testing procedure was 1 in 300 and 1 in 98 for samples in participating laboratories.   Another survey found the joint false positive rate to be 1 in 25. He concluded that widespread HIV antibody-testing in a community like Peoria would result in 400 false positives for every truly infected person identified, because of the extremely low actual prevalence of HIV.

[Source: Quality AIDS Testing, Congressional Hearing No. 100-32, First Session, 100th Congress, October 19, 1987, p. 28-29.]

Finally, I invite you to read my statement describing how my own project, supported by $406,000 in federal grant funds, was sabotaged by waste, mismanagement, and fraud in the AIDS program:

http://members.aol.com/mpwright9/aids10.html

Sincerely,

Michael P. Wright
504 E. Brooks St.
Norman, Oklahoma 73071
405/329-6688
mpwright9@aol.com
[reply by email or telephone preferred]

Patient sues over HIV test mistake
Maryland General named in first lawsuit to be filed after laboratory scandal; Hospital calls suit 'frivolous'

By Julie Bell
Sun Staff
Originally published August 13, 2004

An Owings Mills woman is suing Maryland General Hospital for $2 million, claiming that the Baltimore hospital "derailed my life" by inaccurately telling her she was HIV-positive.

Robyn Joynes-Carey, 35, filed the suit Wednesday in Baltimore Circuit Court, alleging that the hospital was negligent.

Hospital spokesman Lee Kennedy called the lawsuit "frivolous" and said in a statement that the allegations against the hospital were false.

"The hospital will defend [itself] vigorously," he said.

Maryland General said this is the first lawsuit by a patient alleging false test results since state regulators found this year that the hospital's laboratory had sent out hundreds of potentially inaccurate HIV and hepatitis test results.

The lab scandal prompted state and federal investigations, congressional hearings and the resignation of the hospital's chief executive officer. New CEO Colene Y. Daniel is scheduled to start next week.

"I was devastated," Joynes-Carey said yesterday about how she felt last August when her gynecologist told her that she had tested positive for HIV based on results from Maryland General's laboratory.

She said she became depressed and didn't want to live with the thought of developing AIDS. Unable to concentrate, she said, she quit her job as a Baltimore health inspector and was dropped from Morgan State University's master's program in public health for failing to meet academic standards.

Joynes-Carey cried as she explained that her relationship with her teenage daughter also suffered. "My body was there," she said, "but literally I just wasn't there."

In March, after The Sun reported that the hospital had distributed potentially faulty test results, Joynes-Carey's gynecologist's office called to say that retesting of her blood revealed that the lab had made a mistake and that she was not HIV-positive, the suit said.

But in an unusually lengthy statement, Maryland General's Kennedy offered a different version of events.

Maryland General, he said, did send Joynes-Carey's physician a test report on July 31 last year showing that her initial HIV test was positive. But Kennedy said the report informed the doctor not to presume that his patient had HIV based on this one test, which was considered an initial screening.

The report sent to the physician instead said the hospital would send her specimen to an outside laboratory to confirm the finding, a standard procedure for a positive test. The hospital sent the specimen to a state health department laboratory.

Maryland General said it could not disclose the results of tests done there for patient confidentiality reasons. But it said those test results were sent to Joynes-Carey's personal physician by Maryland General last August.

"At no time did MGH ever diagnose Ms. Joynes-Carey as having HIV," Kennedy said.

Joynes-Carey, who is represented by attorney Marvin Ellin, said she now works as a grants compliance monitor with the public school system in Washington. She said she also has been accepted back into Morgan State, though she intends to enroll in a Johns Hopkins University leadership development program instead.

"Ultimately, it's the pain and the stress," she said about why she decided to sue. "It derailed my life."

Copyright © 2004, The Baltimore Sun

IMPORTANT USER NOTIFICATION ORTHO
Antibody to HBsAg ELISA Test System 3 and ORTHO Antibody to HBsAg ELISA Test System 3 Confirmatory Test

Dear Customer,
Ortho-Clinical Diagnostics Inc., (OCD) after consulting with the Food and Drug Administration (FDA), is notifying you of reports of increased initial reactive (IR) and repeat reactive (RR) rates obtained with our Antibody to HBsAg ELISA Test System 3 donor screening assay with false repeat reactive results being confirmed using the Antibody to HBsAg ELISA Test System 3 Confirmatory Test.

We are currently examining available information as to the causes of these events. While our investigation continues, we recommend that you consider implementing the following measures to mitigate the problems noted for the donor screening assay:

Prepare only enough substrate for use within two hours or less.

Where feasible, use the semi-automated wash method for initial and/or repeat testing.

If you are using the Ortho Summit Processor (OSP):

Daily maintenance should also include running the Weekly Maintenance software function. Complete only the procedures performed automatically by the software.

The Weekly Maintenance software function is accessed by selecting the following choices from the software menu:

1. Main menu – select Services/Maintenance

2. Maintenance menu – select Procedure/Weekly

Allow the instrument to run through the three phase rinse cycles of the OSP system and tubing.

Quality Control Procedures

Section 5. Calculation of Percent Reduction Results

b. Calculation of Percent Reduction of the Specimen

The following text has been added to explain how to calculate the percent reduction of the specimen:

Calculate percent neutralization for each pair of control and test wells. Confirm only when % neutralization calculations are ≥ 50%.

Consistent with the addition of the above instructions, the note quoted below that is in the current labeling for the product is no longer applicable and will be deleted:

“Note: Cross control and test values until neutralization of ≥ 50% is obtained or until all four possible calculations are performed.”

Specimen Dilution/Repeat Testing and Interpretation Summary

In order for a specimen to be considered confirmed positive:

a. The optical density values of both control wells must be greater than or equal to the confirmatory test cutoff.

b. Confirmation is achieved only when both test wells reduce the reactivity of the specimen by at least 50%.