Monthly Archives - April 2007

AIDS activists upset by dropped wasting drug

Copyright © 2006 Bay Area Reporter, a division of Benro Enterprises, Inc.
AIDS activists upset by dropped wasting drug
by Heather Cassellh.cassell@ebar.com

AIDS activists are mobilizing after Watson Pharmaceuticals last month dropped a common off-label drug used to assist patients with combating wasting and picked up a generic brand of an approved AIDS-related wasting medication that they maintain is not as effective.

“Taking this drug away from people with wasting syndrome is like taking insulin away from diabetics,” said Jason Riggs, deputy director of the Stop AIDS Project. “Thousands of people with HIV depend on this drug to reverse wasting syndrome, a life-threatening illness.”
Patricia Eisenhaur, director of investor relations for Watson Pharmaceuticals, confirmed that Deca-Durabolin, also known as nandrolone decanoate, an anabolic steroid prescribed by physicians to combat AIDS wasting, was discontinued on March 20.

According to Eisenhaur, the active ingredient to manufacture the drug was no longer available from the Food and Drug Administration-approved supplier. Eisenhaur was unable to provide the name of the supplier, which was the only approved manufacturer of the active ingredient. She told the Bay Area Reporter that the supplier did not provide Watson with a particular reason for not being able to provide the ingredient for the medication.
“We depleted all of our existing inventory and we’ve done everything we can to keep the product on the market,” said Eisenhaur. “But without access to the active ingredient we obviously can no longer manufacture and distribute this product.”
Eisenhaur told the B.A.R. that Watson notified its customers – mainly hospitals, wholesalers, and those who purchase products directly from the company – about the discontinuation of the medication through its normal communications process. Watson did not issue a news release regarding its decision and the company does not plan on making any further public announcements, according to Eisenhaur.
AIDS activists upset
On April 4, Sanford Gross, an associate professor at Illinois College of Optometry, posted on the Yahoo Group PozHealth his discovery that Deca-Durabolin was discontinued by Watson.
AIDS physicians and activists don’t believe that the raw ingredient used to make the medication isn’t available. During an AIDS Treatment Activist Coalition phone conference on April 13 to discuss actions to mobilize to have the medication returned to the market, there was speculation about Watson’s decision. Their suspicions grew through this week as they learned that Savient Pharmaceuticals canceled its patient assistance program for Oxandrin, the second most prescribed drug to combat wasting.
Savient made that decision soon after Watson was approved to manufacture a generic brand of Oxandrin in December 2006.
“The company has always been pleased to provide the patient assistant programs over the past several years,” said Anne Marie Fields, investor relations of Savient. “That’s pretty common to cancel patient assistant program for a drug when it goes generic. It just makes sense. The increase of the introduction of the generic and reduction of the price makes the product more accessible for the patients that need them.”
“We are one of the broadest distributors of generic products of the United States,” said Watson’s Eisenhaur. “So having an opportunity to offer new products to our customers is important to us.”
Eisenhaur told the B.A.R. that the decisions for both drugs were unrelated. According to Eisenhaur, Deca-Durabolin “in terms of Watson’s overall revenues, it is a small product.”
AIDS doctors and activists aren’t satisfied with responses from Watson and Savient.
“I think it’s important for citizens to realize that our health care system for the last 30 years has slowly been hijacked by corporations,” said Dr. Richard Loftus of California Pacific Medical Center, Davis Campus.
But not all activists were quick to blame Watson.
“I’m reluctant to put this squarely on the shoulders of Watson Pharmaceuticals,” wrote Tim Horn, senior writer and editor for http://www.AIDSmeds.com, in a e-mail. “The fact is, we – treatment activists – dropped the ball. We should have been pushing for the approval of nandrolone as a bona fide treatment for HIV/AIDS-related wasting 10 years ago … I just don’t see how we’re to be at all effective in terms of pushing a company to continue manufacturing a drug for an indication it doesn’t even have.”
Which can possibly explain some of AIDS physicians’ complaints that Watson didn’t notify them. Deca-Durabolin isn’t approved by the FDA for doctors to prescribe to their HIV-positive and AIDS patients to treat AIDS-related wasting. It was approved for treating anemia, according to Horn.
According to the FDA’s Web site, Deca-Durabolin is an anabolic steroid that was first approved by the FDA in 1962. The Web site also stated that there is no alternative therapy.
This wasn’t news to physicians treating AIDS patients and activists who are troubled by the changes. The medication was highly successful with low side effects, was cost effective, and was included in the AIDS Drug Assistance Program.
According to Loftus and AIDS activists, there aren’t very many viable options available on the market to assist patients with combating AIDS-related wasting. What is also troublesome to them is that the options aren’t as effective treating the condition.
AIDS physicians and activists repeatedly cited the fact that Deca-Durobolin was studied thoroughly, including for AIDS-related wasting. The studies showed that the medication has many benefits, according to Loftus and those that participated in the conference call. One of the benefits is that it has few side effects compared to alternative steroids, such as Oxandrin, Loftus noted.
He said that the problem with Oxandrin is that it has common side effects, but more important, it damages the liver. Deca-Durabolin did not. Oxandrin, the second most prescribed anabolic steroid, is also more expensive.
According to Nelson Vergel, founder of the Program for Wellness Restoration in Houston, Texas, who coordinated the conference call, AIDS-related wasting isn’t the “number two HIV killer anymore in the United States, it is now number eight.” He believes this is due to life-expanding medications, such as protease inhibitors, commonly referred to as “cocktails.”
That doesn’t make a difference to Loftus, who prescribes the medication, or patients who depend on the medication to help them continue living healthy lives.
“We have a real urgent need to treat weight loss in these patients for the sake of survival,” said Loftus.
This isn’t the first time Deca-Durabolin was removed from the market. Organon International, a New Jersey pharmaceutical company, dropped the drug from distribution in 2002 with no plans to return it to the market. AIDS activists mobilized at that time as well. Eventually, Watson picked up the medication. ATAC is hoping this will happen again.
“This is a decision that effects many people’s health that was made by a corporation that did not even have the courteousness to consult patient groups about this decision,” said Loftus. “This goes back to an old adage that we used to say in ACT UP 15 years ago, ‘Their right to own the drug is more important than our right to have access to it to save our lives.'”
Loftus said about 90 percent of his patients with full-blown AIDS and 40 percent of his HIV-positive patients are on Deca-Durabolin. He sees about 300 AIDS and 1,700 HIV-positive patients. He found out about Deca-Durabolin’s discontinuation from Gross’s posting on PozHealth, but he never received a notification from Watson. According to Loftus, Walgreens pharmacy confirmed Watson’s decision on April 17.
For more information on the campaign to put Deca-Durabolin, back on the market, visit http://watsonboycott.blogspot.com/.
04/19/2007

My Upcoming Lecture in Wilmington , DE

Surviving HIV Resistance in the new era of HAART

Date: 04/25/2007
Time: 12-2 p.m.
Place: Doubletree Hotel
Address: 700 King St.
City: Wilmington
State: Delaware
Zip: 19801
Contact Person: Lori Campbell
Organization/Company: AIDS Delaware
Contact Email: campbell@aidsdelaware.org
Contact Phone: 302-652-6776
Contact Fax:
Event Description:
A lecture for patients and clinicians. Topics include how to avoid serious mistakes in choosing the right combinations, data on new medications and how to predict the best response in the treatment of patients with multi-drug resistance. Nelson Vergel,BsChE, founder of salvagetherapies.org, powerusa.org and the Body Positive Wellness Clinic in Houston, will be the featured speaker.

http://www.delawarehiv.org/calendar_view_details.cfm?new_event_date=04/25/2007&id=285&type=state

STOP CONGRESS FROM DENYING US COMPOUNDED MEDICINES

Compounded medications have greatly improved the quality of the lives of many people living with HIV. Several of these medications (hormone therapies, wasting therapies, quality of life therapies) are not cover by most insurance or ADAP/Medicare/Medicaid formularies, so patients rely on access through compounding pharmacies. Now, access to these medications is facing a huge threat.

A small but powerful group of senators is on the verge of introducing legislation that would severely restrict and possibly deny access to critical medications that many patients rely on, such as women prescribed bioidentical hormones, hospice care patients and children.

Even if you don’t currently rely on compounded medicines yourself, you may need them someday – and you know someone who needs them now. Please join me in contacting Congress to stop this legislation and protect patient access to compounded drugs! Visit www.savemymedicine.org to take action.

This is a copy of the letter that savemymedicine.org sends to your congress people after you input your name and address.

Apr 9, 2007

Senator John Cornyn
United States Senate
517 Hart Senate Office Building
Washington, DC 20510-0001

Dear Senator Cornyn,

I know that you are committed to protecting patients and, as a result,
I hope that you share my concerns about the draft Safe Drug
Compounding Act of 2007 that may soon be introduced by Senators Edward Kennedy, Richard Burr and Pat Roberts.

I rely on compounded medications. Without access to them, I will
suffer.

The Safe Drug Compounding Act would restrict and possibly even deny my access to vital compounded medications, medications that my doctor
has determined I need.

As your constituent, I strongly urge you to oppose this legislation
and look forward to hearing your response.

Sincerely,

Mr. Nelson Vergel

*************************************************************************

WATSON PHARMACEUTICALS ABANDONS AIDS WASTING DRUG

FOR MORE INFORMATION ABOUT THIS GO TO http://watsonboycott.blogspot.com/

April 4, 2007

Allen Chao, PhD

Chairman and CEO

Watson Pharmaceuticals

Corporate Headquarters
311 Bonnie Circle
Corona, California 92880

Dear Dr Chao :

I am writing to ask you to reverse your decision of stopping the manufacture of nandrolone decanoate. I am a national treatment advocate and person living with AIDS who has used your product in the past to reverse wasting syndrome and sustain my lean body mass and quality of life. Several HIV studies have shown that nandrolone prevents and reverses the loss of lean body mass (LBM) that has been linked to increased risk of death in HIV while increasing strength and functional capacity. Your decision to abandon this compound affects me, my work, and thousands of people who needed it to keep living a productive life.

At an average cost of $200 a month for dose of 200 mg a week, nandrolone is a lot more cost effective and more tolerable wasting treatment than recombinant human growth hormone (Serostim) ( cost: $6000 a month). You are the sole supplier of several federal-funded AIDS Drug Assistance and Medicaid programs that have recognized its value and have included nandrolone in their formularies to treat thousands of low income HIV-positive patients nationwide.

I have been told by people in your company that you do not have a source of raw materials anymore. It seems that several raw material suppliers are still available. I certainly hope that your decision has not been originated by the DEA and media frenzy over anabolic steroid use in sports. This negative media exposure completely ignores the important medical uses of this medication. For whatever reason, it is irresponsible for Watson to stop supplying this product without a successor that can guarantee that patients in need get access to this important drug.

Thus, unless you decide to reverse your unfortunate decision of abandoning nandrolone decanoate, our organization and many key stakeholders will start a campaign to boycott Androderm and Watson’s other products via press releases, emails and direct mailings to physicians. I certainly hope we do not have to go to these extreme measures and that you show compassion towards people living with HIV.

Please have someone from your medical and legal department call me directly at 713-539-1978 to discuss this matter before the patient and physician communities are activated.

Sincerely,

Nelson R. Vergel

Director

cc:

Mr Jeff Murray- Food and Drug Administration

Ms Karen Tandy- Drug Enforcement Administration
Mr Steve Baragona- HIV Medicine Association (HIVMA)

Mr Rob Banaszak- The American Academy of HIV Medicine (AAHIVM)

Ms. Cathy Olufs- President- The AIDS Treatment Activist Coalition (ATAC)