ACT UP wins price break on Crixivan
Commission orders 33% cut in "other local priorities"
Mandatory military AIDS discharge to be repealed
Engineered AIDS vaccine not effective - U.S. study
HIV-infected patients get boost from massage therapy
Bayer offers $270 million to settle HIV lawsuits
New technology available for cleaner water
ACT UP wins price break on Crixivan
ACT UP Golden Gate, ACT UP New York, ACT UP Philadelphia and the PWA Health Group have forced Stadtlanders mail order pharmacy to offer a 19.5% cash discount on the retail price of Crixivan, a powerful new AIDS drug manufactured by Merck & Co. of Blue Bell, PA. Stadtlanders, based in Pittsburgh, is the sole commercial distributor of the drug. The AIDS activist groups had threatened to initiate a boycott of Stadtlanders if the company failed to reduce the price. Stadtlanders had been charging a 37% markup on Crixivan for uninsured persons and for many insured people who must pay a percentage of their prescription costs. Stadtlander's markup brought the price of Crixivan to $495 per month. The average industry markup ranges between 6% and 17%. In the face of activist pressure, the company lowered its markup to 10%.
Four members of ACT UP New York were arrested the night before Stadtlanders capitulated. The activists plastered the company's showcase New York City store with signs denouncing the company's "price gouging" and "AIDS profiteering." Commented ACT UP New York member Mark Milano, "We wanted to bring the message home to New York City that Stadtlanders wouldn't get away with price gouging people with AIDS."
Stadtlanders will offer to enroll People with AIDS (PWAs) who are paying out of pocket for Crixivan in a discount program. The drug will be available for a contract price of $398 per month. The discount program has an enrollment fee of $18.00 per year, and buyers who have already paid cash for the drug will be offered a refund based on the discounted price. People paying cash will save about $100 per month; those paying a 20% insurance co-payment will save about $20 per month under the new plan.
Added ACT UP Philadelphia's Bob Kahn, "It is inhumane for Stadtlanders to use its monopoly position as sole distributor of Crixivan to exploit the desperation of tens of thousands of people with HIV who have few remaining treatment options."
"The price of Crixivan is still too high, and we want to send a message to Abbott Labs, Merck, and Hoffman-La Roche that we will not tolerate price gouging," commented ACT UP Golden Gate's Bill Thorne. "Those companies are next." All three companies manufacture powerful new AIDS drugs called protease inhibitors, and all have come under scrutiny for the extremely high price of their drugs. The price of Abbott's protease inhibitor is $8,500 a year. In addition, most PWAs must take several expensive therapies concurrently.
Merck has stated that it will not provide Crixivan to patients who have been denied coverage by their insurance companies. Insurers, however, are reluctant to provide coverage due to the high cost of Crixivan. In addition, the program will bar people with AIDS from receiving the drug if they live in a state where Crixivan has not been added to the AIDS Drug Assistance Program. Many public programs cannot afford to include Crixivan in the drugs offered to patients. Managers for Pennsylvania's AIDS Drug Assistance Program, called the Special Pharmaceutical Benefits Fund (SPBP), are in the process of adding Crixivan and other protease inhibitors to the list of what SPBP will cover. Governor Ridge has proposed a 30% cut in funding for SPBP, and it is unclear how the program will pay for the new drugs.
AIDS activists have also called on Merck to expand the eligibility criteria for the its patient assistance program. The program is intended to provide Crixivan to people in need who do not have insurance and are unable to pay full price. The company has stipulated that patients earning more than $20,000 per year will be ineligible for patient assistance. Crixivan will cost about $6,000 under the program, and patients generally require at least two other costly medications. "The $20,000 income cap is ludicrous," commented ACT UP Golden Gate's Edward Zold. "A person's drugs alone can easily cost $20,000. Thousands of people with AIDS will be left out in the cold. Merck must raise the maximum income cap to a minimum of $30,000 per year, more for couples and families."
The activists stated that they will closely monitor Stadtlanders over the next weeks to ensure that the new discount program is well promoted and running smoothly. "This drug has meant new hope for a lot of individuals with HIV," said ACT UP Philadelphia member Steven Parmer. "We will continue fighting to make certain that Stadtlanders meets the needs of people with AIDS." Patients interested in obtaining Crixivan can contact Stadtlanders' hotline at 1-800-238-1548.
Commission orders 33% cut in "other local priorities"
The Philadelphia HIV Commission, at its April 24th continuation of an earlier emergency meeting, ordered a 33% reduction in funding to the area of indirect services known in AIDS planning documents as "other local priorities."
An ad hoc committee of the Commission will meet before May 1st to decide exactly how to spread the cut among the services listed in that category. The services under fire include Consumer Involvement, Coordination of Meetings, Needs Assessment, New Jersey Planning and Coordination, OASIS, Regional Food Coordination, MIS, Case Management Coordination, and Quality Assurance. Of these service categories, Regional Food Coordination, Needs Assessment and Case Management Coordination have already had a previous reduction of 20% as a result of cuts made by the Commission on April 10th.
The cuts stem from a HRSA announcement late last month that Philadelphia would lose about $1.8 million dollars of Ryan White Title I Supplemental money currently being used to support services in the region for people living with HIV/AIDS. The cuts were enacted against Philadelphia effective April 4th, but the city health department redirected $157,000 to keep the services afloat for this month while the Commission decided how to distribute the loss of federal funds. To date it is still not clear why Philadelphia was reduced in funding in this year's competitive process for Ryan White Supplemental funds, although there has been much speculation that both federal politics and a poor Philadelphia application may have played a part.
Also announced at the meeting was the results of the Commission-ordered AACO inquiries to local AIDS service providers to see if there might be voluntary cuts in agency budgets that could be offered by the agencies. The cuts would be used to help offset the $1.8 million loss while at the same time not disrupting direct services to people with AIDS. Some local AIDS services providers volunteered cuts totaling $133,588. Of the 54 agencies currently receiving Ryan White funds, 22 providers volunteered cuts, 9 responded that they could not make any cuts, and 23 did not respond at all. The voluntary cuts were proposed by providers in the following service areas:
Medical Care: $56,463
Case Management: $29,354
Home Health Care: $11,851
Mental Health Therapy: $7,767
Client Advocacy: $1,394
Information and Referral: $6,600
Respite Care: $4,626
Risk Reduction: $900
Transportation: $355
Translation Interpretation: $5,000
Systemwide Coordination: $9,278
Total $133,588
Of the $1.8 million in cuts the Commission had to make, all but approximately $200,000 have been approved, so far without impacting on "direct services" to people with AIDS. There seems to be consensus within the Commission that direct services will be spared if at all possible in the cuts, targeting instead indirect services that support coordination activities, services that could be billed to other sources of revenue besides Ryan White, etc.
The Commission will hold its next meeting on May 1st from 3:00 p.m. to 5:00 p.m. at 1199C Union Hall, 1319 Locust Street in Philadelphia. The meeting is open to the public. At this meeting it is expected that the Commission will order the additional necessary cuts and approve the specifics of the cuts already ordered in "other local priorities".
Also the Commission will review the results of another AACO inquiry which the Commission has requested, this one directed to the 23 agencies that did not respond to AACO's first request for voluntary budget cuts as well as the 9 agencies which did respond but did not offer any voluntary cuts. This time AACO will hold individual conversations with these agencies and make specific recommendations to them on what cuts the agencies may want to offer that would not harm direct services to people with AIDS.
Mandatory military AIDS discharge to be repealed
House and Senate budget lawmakers agreed Wednesday to repeal the mandatory discharge policy for members of the military testing positive for HIV.
Senate Appropriations Committee Chairman Mark Hatfield told reporters the repeal would be included in a fiscal 1996 spending bill currently being negotiated with the House and the Clinton administration.
Hatfield said "we have succeeded in repealing that regulation relating to HIV in the military." The Oregon Republican had sponsored the repeal which had passed the Senate as part of its version of the 1996 spending bill.
Leading the fight against the repeal was House Republican Bob Dornan of California. Hatfield speculated that another attempt to impose the mandatory discharge would be made in the House when it considers the 1997 defense authorization. The mandatory discharge was opposed by the administration, the military and defense policy leaders.
Hatfield said the repeal would take effect once the entire spending package is adopted by Congress and signed into law. Several obstacles to that outcome remain, including disputes over environmental policy. These are currently being negotiated between Republicans, Democrats and the White House.
Engineered AIDS vaccine not effective - U.S. study
A five-year clinical study of a genetically engineered AIDS vaccine has shown it to be ineffective in helping to halt progress of the deadly disease, the U.S. military announced last month.
The study of the candidate vaccine "gp160," made by Microgenesys Inc. of Meriden, Connecticut, was conducted by Walter Reed Army Institute of Research in collaboration with the National Institute of Allergy and Infectious Diseases and civilian medical centers around the United States.
The study ended in December and involved a major cooperative effort by military and civilian doctors using 608 volunteers with early infections resulting from HIV.
"While gp160 was hoped to slow the progression of the disease, unfortunately results from the study show no clinical improvement that could be attributed to the vaccine used as adjunct therapy (along with other treatments) for HIV infection," the Army said.
Officials said the test, in which infected civilian and military volunteers were divided about equally, was the first successful HIV vaccine therapy trial ever performed with a vaccine engineered artificially in a laboratory.
The Army Medical Research and Materiel Command said that while gp160 did not help slow progression of the disease, it showed that such interagency trials could be successfully conducted among early-stage volunteers infected with HIV.
Enrollment of 608 volunteer subjects began in November of 1990 and subjects were given regular injections of either the vaccine or a placebo every two months. Of the 608 volunteers, 483 completed the study, 104 dropped out and 21 died before the study was completed, the Army said.
Aside from determining whether individuals whose immune systems were threatened by HIV would respond to the vaccine, the test was run to show the feasibility of conducting such a large and complicated long-term study.
"The study demonstrates that multi-year, interagency, multi-medical center trials can be successfully conducted in early-stage, HIV-infected volunteer subjects," the Army research group concluded.
HIV-infected patients get boost from massage therapy
Patients infected with HIV who received a 45-minute massage five days a week for four weeks raised their immune system's ability to fight the infection, researchers report in the International Journal of Neuroscience.
The researchers, of the University of Miami School of Medicine's Touch Research Institute, found that when massage therapy was employed, HIV-infected patients experienced an increase in the number of disease-fighting natural killer cells and natural killer cell cytotoxicity (the ability to destroy infected cells). In addition, the subjects felt less anxiety and had lower levels of the stress hormone cortisol after receiving a massage, the researchers reported.
In order to evaluate the effects of massage therapy, 29 HIV-infected men were given a daily massage for one month. Some of them also were monitored during a period of no massage as a control group.
"These immune measures may be especially important in protecting health in HIV-positive people since HIV destroys CD4 cells; thus, the natural killer cells and cytotoxic cells represent another type of immune cell which may still afford some protection," said Dr. Gail Ironson, professor of psychology and psychiatry and the study's chief investigator.
Bayer offers $270 million to settle HIV lawsuits
German chemicals giant Bayer AG has offered to pay around $270 million to settle several U.S. lawsuits accusing the group of selling HIV-tainted blood products to hemophiliacs.
"The four companies involved have offered to pay a total of $600 million and our share of that would be around 45 percent," said Christina Sehnert, a Bayer spokeswoman.
She added the sum represented an offer which had not been accepted by the plaintiffs.
Rhone-Poulenc, Baxter International Inc. and Alpha Therapeutics Inc. joined Bayer in making the offer to settle around 750 lawsuits filed around the United States.
"We hope that these lawsuits which have been looming over us for years, will be settled
soon," Sehnert said.
Portions of the settlement would go to as many as 10,000 patients or their families, according to Corey Dubin, head of the "Committee of 10,000" which represents the plaintiffs.
But Dubin was skeptical about the chances of the offer being accepted, partly because nearly every plaintiff involved must accept the offer.
"I think we'll find that the deal won't fly," he said. "These people are not about to give up their rights."
If accepted, however, the deal would mark the third time Bayer settled lawsuits filed worldwide after it and other groups sold blood products infected with the HIV virus to hemophiliacs.
Hemophiliacs were infected with HIV -- the virus that causes AIDS (Acquired Immune
Deficiency Syndrome) -- from imported blood products.
In March, Bayer and four other groups agreed to make a one-time total payment of $420,000 and continuing monthly payments to over 450 claimants or their families in Japan.
Sehnert said Bayer's portion of that settlement was $66.4 million.
In Germany, a similar settlement was reached in the late 1980s with firms paying a total of about $166 million to patients and families.
Sehnert said the U.S. lawsuits were the last outstanding claims involving HIV-tainted blood products.
Dubin, representing the hemophiliacs, said that despite the problems with the deal the HIV-infected and hemophiliac community would like to see a settlement.
Plaintiffs issue response
Attorneys for the plaintiffs in the blood case issued the following statement upon the Bayer announcement.
"The public announcement by the manufacturers of Factor concentrate to offer $600 million for a proposed class action settlement of the claims of members of the hemophilia community infected with the AIDS virus, plus some amount for costs and attorneys' fees, is made in obvious recognition of industry's potential legal liability for the tragedy which their products caused to thousands of our fellow citizens.
"The ongoing consolidated litigation in Chicago managed by the court appointed plaintiffs' steering committee has raised serious questions of legal responsibility and culpability. The pretrial investigation and discovery which has been conducted in these cases raise profound questions as to why Factor concentrate derived as it was from the pooled plasma of thousands of paid donors and infected with virus was not sterilized or purified at a point in time even before the AIDS virus entered the blood supply. To be sure, the defendants continue to deny any liability as they have from the outset.
"The public at large and the hemophilia community in particular should recall the fact that months after Judge John F. Grady initially certified a class in August, 1994, the fractionators challenged that ruling, eventually obtaining a favorable opinion from the Seventh Circuit Court Of Appeals requiring the decertification of the class. The manufacturers had all sorts of reasons at that time to claim that a class action was not appropriate. Now, almost two years later, the defendants have decided that they should attempt a class action settlement after all. What may have changed in the interim is their awareness that they now face legal exposure in hundreds of individual cases.
"Significantly, the defendants -- in their actual written proposal to me -- make clear that a condition of their offer is that 95% of the plaintiffs in the currently filed court cases will support their plan; otherwise, they are entitled to withdraw the offer. What this means in plain English is that if the hundreds of plaintiffs with individual claims filed in court do not agree to drop their cases in exchange for accepting whatever they might manage to get from the global settlement fund, all bets can be off. In addition, the actual written offer makes clear that among the thousands of victims who could participate, not more than 100 can decline to go along with the terms and conditions of the defendants' proposal. Otherwise, once again, the defendants can pull the plug. Furthermore, the defendants have set a deadline of May 20 for this 95% target to be reached, a deadline which could likely prove unrealistic in terms of any thoughtful decision-making by the plaintiffs involved. In fact, the proposal does not make a flat out offer. It says that the manufacturers are "contemplating an offer" which could be made "subject to important conditions." So great care must be exercised in dealing with this proposal to assess whether it is fair and realistic under present circumstances.
"But whatever the motives behind this offer and whatever may be currently stated conditions, we welcome this proposal as a responsible step on the road to a final settlement of a vast majority of the claims. We stand ready to work in a cooperative spirit with the manufacturers to consummate an agreement which will permit the amicable resolution of these claims and justify court approval.
"The plaintiffs' steering committee will continue aggressively to complete the pretrial preparation of the consolidated litigation before Judge Grady in the Chicago federal court. We are now approaching the final phase of that pretrial effort after more than two years of extensive investigation and discovery. That work effort will continue unabated in support of individual cases, some number of which will certainly be prosecuted through trial to a jury verdict.
"In the interim, my advice to every affected member of the hemophilia community is for each person, in consultation with any attorney of his or her choosing, to consider the risks and benefits of the proposed settlement. The bottom line questions should include: what will I receive and when will I receive it? What are my alternatives if I decline to participate? What are the risks and strengths of my individual case? If I have a lawsuit pending, is it more likely than not that what I stand to receive from the settlement is more than what may be obtained at trial or through a subsequent individual settlement?"
New technology available for cleaner water
As the debate rages on over stricter enforcement of the 1974 Safe Drinking Water Act versus limited funds available for necessary upgrades, growing public awareness and concern for our nation's drinking water is prompting an immediate need for solutions to this vital issue. In response, Sionix Corp., a research and development company based in San Diego, says that it has the technology that may satisfy both sides of the debate. Public water districts can now upgrade outdated equipment and efficiently operate their treatment facility at an affordable price, the company says. By improving the methods of how to treat the billions of gallons of water pumped daily out of their plants and into people's homes, the plants will ensure that quality drinking water will be provided to consumers.
According to U.S. Environmental Protection Agency reports in the Federal Register, more than 50,000 communities in the United States are currently in violation of the Safe Drinking Water Act, and those numbers will increase as new EPA rules for smaller rural public water systems become effective.
"We recognize all the challenges the industry faces and know we have solutions to help them," said Michael Maung, president of Sionix. "Oftentimes, consumers are warned too late that their water has been contaminated. We want to work hand-in-hand with the water industry to solve a very serious problem."
After years of independent research and field studies, Sionix says it has developed an array of patented products incorporating inexpensive breakthrough technology for the water industry. The software program can operate an entire water treatment plant and works in conjunction with modules that monitor a variety of parameters such as pH, temperature, turbidity, and redox. This will help the water industry to comply with complex U.S. EPA regulations as well as assist them in running the day to day operation of their facilities. No longer will a plant operator spend precious hours typing and filing tedious reports required by the Health Department, the company said. The software includes a report generator that can assist the operator in compiling and filing the data. Also included in the package is an extensive library on federal and state Clean Water Act regulations, operator educational training program, and a management application.
More importantly, Sionix says it's technology will help to ensure that incidents like the 1993 Cryptosporidium outbreak in Milwaukee will not happen again. Although Milwaukee's filtration system met industry standards, it failed to detect and remove these microscopic organisms. The incident hospitalized more than 4,000 residents; and to-date, over 120 people -- mostly people with AIDS -- have died as a result of that epidemic. The Milwaukee outbreak is now being referred to as a "wake-up call" by water treatment industry leaders.
"There is no logical reason why our water supply cannot be contaminant free," said Maung. "Our technology is aimed at making a that possible."
Sionix designed its automation software and control hardware for small rural water districts who have limited financial resources; yet it may be installed in major metropolitan communities to efficiently operate a larger scale system.