Monthly Archives - May 2007

LECTURES IN FLORIDA – JUNE 2007

TOPIC: SURVIVING HIV RESISTANCE- How to avoid mistakes in using new HIV drugs

Reserve any lecture by calling 1-800- 810-3703 or email HIVSeminars@aol.com

TUESDAY, JUNE 12: MIAMI
11 am- Noon
Jackson Health System
1622 NW 12 Ave ACC West Room 125

WEDNESDAY, JUNE 13- PORT SAINT LUCIE
10:30 am- noon
5150 NW Milner Dr (off Midway Road)


WEDNESDAY, JUNE 13- FORT LAUDERDALE
6:30 pm- 8 pm
ArtServe Library
1350 East Sunrise Blvd


THURSDAY, JUNE 14- TAMPA
Baker & Company General Store & Antique Emporium
2502 N Howard

Companies Abandon AIDS Wasting Patients

On March 20, Watson Laboratories stopped the production of nandrolone decanoate (old brand name: Deca Durabolin), a low cost injectable anabolic used for HIV wasting, citing lack of raw material suppliers for the product. Patients found out when they went to their pharmacies for a prescription a week later.

Although there are other generic makers of the nandrolone internationally (easily located on the Internet), this offers little help to U.S. patients. Anabolic steroids and testosterone are designated by the Drug Enforcement Administration (DEA) as class III drugs, which are illegal to import even for personal and medical uses.

In the past 20 years, anabolic steroids have suffered from a lot of bad publicity and misconceptions due to their use in sports and bodybuilding. However, that did not stop activists in the 90’s from convincing doctors and researchers to look into these medicines to help those with HIV related wasting syndrome. Since then, over 8 studies have been performed that showed nandrolone and oxandrolone ( brand name Oxandrin, an oral anabolic) to be effective and safe for increasing lean body mass (LBM) and strength in men and women with HIV. Many physicians quickly learned how to prescribe them and monitor their use for helping their HIV positive patients to survive what used to be one of the main causes of AIDS mortality.

Watson Laboratories are the only suppliers of thirteen of the 50 AIDS Drug Assistance Programs (ADAPs) that decided to cover payment for these two anabolic agents for patients with low income. “This is the safest and most cost effective anabolic steroid in the world and now we have no manufacturer in the U.S.” says Vergel.

While Watson was abandoning nandrolone, another company was making a decision that would also strain options for HIV wasting patients. Savient Pharmaceuticals informed patients in April 2007 that they stopped their 10 year old patient assistance program (PAP) that gave free Oxandrin (oxandrolone) to HIV patients with no insurance and third-party payment sources. Oxandrin, another anabolic agent used for weight gain in HIV, costs $1300 a month and most people cannot afford it. This PAP was set up by BTG Pharmaceuticals (bought out by Savient later on) in 1996 after activists pressured the company to provide the drug for free to those with no access or means. Like nandrolone, only 13 states include Oxandrin in the ADAPs , so many patients will have no way to afford this drug. Savient informed patients that Watson Pharmaceutical was to sell generic Oxandrin, and thus, there was no further need for patient assistance. Unfortunately, the generic price for Oxandrin sold by Watson is no different than the brand name product, which will still be sold by Savient. Watson will not provide free Oxandrin via a PAP either. This is the first time in AIDS history that a company stops a PAP while still selling the drug.

Oxandrin is an oral anabolic steroid used in HIV wasting and it is approved to treat unintentional weight loss due to illness. It has been shown to be midly effective in men, women and kids with HIV wasting. The advantages of this drug is that it can be taken by mouth daily (nandrolone needs to be injected in the butt once a week) and that it is approved for a weight loss related indication. However, unlike nandrolone, Oxandrin (oxandrolone) can increase liver enzymes and could be problematic for people with liver disease, taking medications heavy on the liver, HIV medications like Reyataz, and those with Hepatitis B and C.

A month supply of Oxandrin (brand name or generic) costs around $1300 for 20 mg a day. Watson’s nandrolone costed around $200 a month for 200 mg a week.

“The decisions of these two companies have a huge impact in many of my patients’ health” said Dr. Richard Loftus, a San Francisco physician with a large HIV practice. “We use nandrolone extensively in patients who have problems gaining weight and who feel fatigued, even with undetectable viral loads. Many of my patients feel better and have experienced no side effects at the doses we use in HIV”, added Dr Loftus.

Even though wasting syndrome has improved dramatically since protease inhibitors were introduced 10 years ago, some patients still need extra help to hang on to their muscle to sustain health and productivity. A study performed at Tufts University School of Medicine by Wanke et al. reported that as many as 29 percent of people with HIV in the era of HAART are still losing weight or lean body mass, despite undetectable viral loads. In the 80’s, researcher Dr Donald Kotler found that the loss of lean body mass can dramatically decrease survival in HIV-positive people

A patient and a doctor himself, Dr. Nathan Sherlock knows first hand about the importance of nandrolone for his health and that of his partner. ”My partner has had a significant problem with wasting due to AIDS and the only way he has been able to stop the dangerous weight loss is to use anabolic steroids. He is also hepatitis B positive. His doctor first prescribed Oxandrin in 1998. Within a couple of weeks he had chemical induced hepatitis with the symptoms of nausea, vomiting, loss of appetite and jaundice. His liver enzymes were all elevated. He stopped Oxandrin and the symptoms promptly resolved. His doctor then prescribed nandrolone 200mg/week and he regained weight back to his norm with no side effects. When he stops taking it the wasting returns so he has been on nandrolone for close to 9 years now”

When asked about his own experience, Dr. Sherlock adds : “I have been taking nandrolone for wasting due to AIDS for over 10 years. Every time I have stopped taking nandrolone I experience rapid weight loss that can only be reversed by resuming the use of nandrolone.”

This belief is also shared by Al Benson, a HIV treatment advocate in Los Angeles.”Nandrolone is truly ‘the Lazarus drug’ …it has brought me back from the brink, restored my health and made all the difference in the quality of my life, ” added Benson.

Compounding Pharmacies- A threatened last option for wasting treatments

Many doctors and patients do not know that nandrolone and oxandrolone can also be obtained legally by prescription in small quantities through compounding pharmacies at a lower cost, but those pharmacies are at risk of being shut down. The DEA has raided several in the past few months, according to one of the owners of one of the pharmacies. Senator Kennedy have tried to pass legislation to regulate these companies more heavily with the help of large pharmaceutical companies. So, no one knows how much longer this option for economical medicines will be available. Fortunately, there is a strong consumer movement to protect these outfits from closure by the government (visit savemymedicine.org)

Compounding pharmacies like Applied Pharmacy (appliedphramacyrx.com), Kronos (Kronospharmacy.com), the Compounding Shop (gotocompoundingshop.com), College Pharmacy ( collegepharmacy.com) and other companies are still economical sources of nandrolone, oxandrolone, and testosterone gels and injections. However, they do not process insurance claims and are not equipped to supply AIDS Drug Assistance Programs (ADAPs), insurance, Medicaids and Medicare Part D vendors.

What other HIV Wasting drugs are out there?

One of the FDA approved products to treat HIV wasting or appetite loss, Megace (megestrol acetate), tends to produce its weight gain due to increases in fat rather than lean body mass — and adding fat during AIDS wasting has not been shown to improve survival. Megace, a female sex hormone based product, has also been associated with side effects such as diabetes, blood clots, impotence and the development of female sex characteristics. Another agent approved to treat HIV wasting, Serostim (recombinant human growth hormone), can cost as much as $6,000 a month, so most insurance companies do not want to pay for it and many ADAPs have limited its use due to prior bribes and scandals created by its manufacturer (Serono). Serostim requires daily injections and can cause joint aches, swelling and diabetes.FDA-approved appetite stimulants such as Marinol contain the psychoactive ingredient in marijuana (THC) that can be an issue for many people with HIV who are in recovery. Also, it’s theorized that Marinol may simply owe its ability to increase weight to a side effect of the THC high — that people get the munchies and tend to eat more.

What can you do?

A nationwide network of activists is swinging into action around this issue. Vergel says, “I feel very strongly that “quality of life” drugs need as much advocacy efforts as HIV antivirals, especially in this era when we are living longer. After all we have done as actvists to secure anti-wasting medicines, I hope we do not lose ground now and fall asleep when important medicines like nandrolone are dropped without notice.”

For more information or to find out how to help, please visit
http://savehivwastingmeds.blogspot.com/

Serono and Serostim’s Corruption

This was first brough to light by Michael Mooney in 1999. It took years but Serono is now paying for this troublesome corporate decision. You can read the original article in 1999 here:

http://medibolics.com/kickback2.htm

Ex-Serono executives acquitted in USA of bribing doctors

04/05/2007
www.pharmatimes.com

A federal grand jury has acquitted four former executives of Switzerland’s Serono, which has just been acquired by Merck KGaA, of charges that they illegally promoted its human growth hormone product, Serostim to treat muscle wasting in patients with AIDS.The US District Court jury in Boston set aside all charges brought in 2005 against the executives (Mary Stewart, John Bruens, Melissa Vaughan and Marc Sirockman) at Serono, which included conspiracy and giving doctors expenses-paid trips to Cannes, France for a medical conference in 1999 where they agreed to write up to 30 prescriptions for Serostim (somatropin), typically costing $21,000 for a 12-week treatment.At about the same time the US Food and Drug Administration approved the drug, protease inhibitors came on the market, making patients less prone to AIDS wasting. Demand for Serostim began to fall and at a meeting in Boston in March 1999, Mr Bruens and Ms Stewart told Mr Vaughn, Mr Sirockman and several other regional sales directors that they needed to “dig their way out” of a financial crisis, according to the indictment.Sales reps were required to identify the highest prescribing physicians in their region and then target them with free trips to boost prescriptions to $6 million in 6 days, prosecutors had claimed.”We believed this is a case that should not have been brought and the speed with which the jury returned its verdict (just three hours) confirmed our beliefs,” said Adam Hoffinger, an attorney for Ms Vaughn. He added that the trip was not offered in exchange for writing prescriptions for Serostim, noting that the defendants “had no intent to bribe any doctors, and they did not bribe any doctors. It was a legitimate medical conference.”Serono agreed a deal with the US Justice Department in October 2005 to plead guilty and pay $704 million to settle charges that it knowingly encouraged the submission of fraudulent claims for Serostim reimbursement under government health programmes.ReutersIt also agreed in 2005 to plead guilty to two criminal charges and to pay a $137 million fine resolving an investigation into how the company marketed the drug called Serostim, which was approved by the U.S. Food and Drug Administration in 1996.The drug was marketed in the United States by Serono Inc. of Rockland, Massachusetts.Also in 2005, Serono agreed to pay $567 million to settle civil charges that it knowingly caused the submission of false claims for Serostim that were not eligible for reimbursement under government health programs.>From 2005 Boston Globe:Some HIV/AIDS advocates have said the “bad blood” with Serono will not affect their position on new uses for Serostim, the Globe reports. However, “it’s clear this vocal and influential constituency, which often weighs in with regulators on AIDS drugs, now doesn’t trust Serono and will be skeptical of any new promises or clinical claims from the company,” according to the Globe

IF YOU HAVE PAID FOR ANY PART OF SEROSTIM’S PRESCRIPTION IN THE PAST, READ THIS:

Mr. Vergel:

I am an attorney involved in the settlement of litigation against Serono. There’s about $2 million available to reimburse anyone who paid anything out of pocket for Serostim. Despite our best efforts to date to spread the word about the settlement and the availability of the money, very few have filed proofs of claim and most of the money is at risk of going unclaimed.

If you think you can help publicize this, please contact me. Your services would not be compensated, so you’d have to be interested in this as a pro bono project.

Richard W. Cohen
Lowey Dannenberg Bemporad Selinger & Cohen, P.C.
White Plains Plaza
One North Broadway, 5th Floor
White Plains, NY 10601
914-997-0500 (main line)
914-733-7239 (direct line)
rcohen@lowey.com