ASCO Drug Shortage Session

First in a series of reports on the sessions I attended at the Annual  ASCO meeting. 

I attended the Drug Shortages:Why is this happening and how can we treat our patients session at ASCO presented by Dr Kantarjian, Mr Neas and Dr Schilsky.

How has the shortage of chemo drugs affected the treatment of patients?
Most generic drugs do not have real alternatives that patients can be given. So this has created problems for the regular treatment of cancer patients and those on clinical trials. Oncologists can delay treatment which increases patients anxiety. Onocologists may also choose to use an alternate drug but that drug may not be as effective nor will the provider necessarily have experience administering the drug or be as familiar with the side effects of the drug. If the patients are switched to the brand-named drug then drug companies may require higher copays or patients may have to pay the cost out of pocket.

If there is a shortage is of a drug being used in a clinical trial the accrual of patients may have to be lowered or the trial might be stopped all together. If the drug is switched that might be a violation of the protocols of the trial and my confound the data.

What about the gray market or counterfeit drugs? 
The gray market is made up of secondary drug distributors. These distributors might hoard drugs and then charge exorbitant prices for the drugs that are in short supply.
As you may know counterfeit Bevacizumab was provided to wholesalers who then sold the drug in the US. This is an international problem not just a problem in the US.

Why can't other pharmaceutical companies just pick up the slack?
It takes 1 and a half years to build a sterile injectable facility. So even if a company decides now they want to produce a drug that is in short supply it will take over a year and a half and FDA site approval before any drug can be manufactured. What if a company already produces other sterile injectable drugs in an FDA approved facility the process must be approved by the FDA before the drug can begin to be manufactured.

What does the future holds?
A recent federal law will require companies to provide a 6 month notification of a shortage or plant shut-down.
Pharmaceutical companies have provided the FDA with $1.5 billion to help shorten the approval process of the manufacturing facilities.

Recommended by the speakers was further FDA approval of foreign manufacturing facilities and
the establishment of a pricing floor for generics.


After listening to the speakers I was pleased to see the active part that ASCO took over the past few months in resolving the drug shortage issues.

Dee
Every Day is a Blessing!

Doxil Shortage Development

On the Doxil web page Rob Bazemore , the president of Janssen Products ( J&J is the parent company) , states;

"I am saddened to share news today that Ben Venue Laboratories, Inc. (BVL), our third-party supplier who manufactures DOXIL^®, announced its temporary suspension of manufacturing and distribution of drug products. Click here to read a posting on the BVL website announcing this news and here to read our related official communication to healthcare providers.

This voluntary decision is a result of an internal BVL review, which indicated that routine preventive maintenance did not happen at a specified time for some manufacturing equipment. This required maintenance included steps to ensure that machinery meet all qualifications before being used again. BVL is halting production to conduct a site-wide assessment to determine the potential impact, if any, and will implement any corrective actions if needed.

This temporary suspension of manufacturing by BVL impacts the production and release of DOXIL^®, which is currently in short supply and not available beyond product already allocated to patients in the DOXIL^® C.A.R.E.S. Physician Access Program. We are not able to estimate timing when DOXIL^® may return to the market as BVL has not provided a commitment on when its manufacturing operations will resume. In light of this situation, patients should speak with their physicians about alternate treatment options.

"

For the complete statement please see http://www.doxil.com/doxil-supply-shortage.

Doxil is a doxorubicin Hydrochloride encapsulated in liposomes for intravenous use. The manufacture of Doxil includes a fermentation process ( a streptomyces bacterium is used) and subsequent chemical conversion processes to reach the final drug stage. In Europe, Doxil is know as Caelyx. The patent on Doxil expired in 2009 but it has orphan drug exclusivity until May 2014 . Orphan Drug status is given to those drugs that are used to treat rare conditions with less than 200,000 patients using it per year. Yes, ovarian cancer is considered a rare condition with ~25,000 women diagnosed a year. That status protects J&J from generic drug competition and allows the company to recoup its development and marketing costs.

Prior to teaching I was a process chemical engineer for an over -the-counter product manufacturer. I understand the need for maintenance. I remember how long it took for the manufacturing plant to break apart the pipes , clean & sterilize them and restart. It is not an overnight procedure. It may take upwards of two weeks. Then the fermentation must begin again so that also adds time to the process. My hope is that J&J does not wait to find a new back-up contract manufacturer. In this economy there may be other manufacturers just waiting to fill the void. It will take them the same time to startup the process but then all the women who need it will have access to the drug. Or J&J can give up it's drug exclusivity and allow other manufacturers to produce the drug.

Please don't wait J&J, women's lives are at stake.

Dee

Every Day is a Blessing!

Petition to End Ovarian Cancer Drug Shortages

In the past few months I have written about chemotherapy drug shortages. I personally know three women whose chemo has been changed or delayed because of the doxil shortage.

Just imagine getting a cancer diagnosis and learning that the drug that could eliminate the cancer is unavailable.

Please go to this petition site sponsored by OCNA and sign the petition. I did!

Dee

Every day is a Blessing!

Chemo Drug Shortages

Over the past few weeks I've been reading a number of articles on chemotherapy drug shortages. Here is just one video and article on the topic.

On June 16, 2011 Paclitaxel the generic brand of Taxol was put on the American Society of Health System Pharmacists current shortage list(ASHP). These drugs are manufactured in various milligram dosages from 6mg too 300 mg. The reasons given in the bulletin were:

Manufacturing shortage - Teva

Increased demand - APP

No reason - Bedford

There is no direct substitution for paclitaxel.

On June 23,2011 ASHP added carboplatin solution for injection to the list.

The reason for the shortage was given as:

Manufacturing shortage- Sandoz, Teva, Hospira

Discontinued manufacturing in May 2011- Bedford

These two chemotherapy drugs are the standard of care for women initially diagnosed with ovarian cancer and for many who recur. Paclitaxel is also used by women diagnosed with breast cancer and off label for other cancers.

From the ASCO in ACTION website I learned:

June 23, 2011

Drug Shortages Legislation Introduced in the House
This week, Representatives Tom Rooney (R-FL) and Diana DeGette (D-CO) introduced H.R. 2245, legislation that would amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration (FDA) with improved capacity to prevent drug shortages. As an important first step in addressing the complex issue of drug shortages, this bill is consistent with recommendations from the November 2010 Drug Shortages Summit co-convened by ASCO. The proposed legislation includes provisions that would expand FDA authority to require manufacturer notification of shortages and market withdrawals, and enhance communication among health care providers and stakeholders in the pharmaceutical supply chain about the nature and expected duration of shortages. ASCO and the Summit co-conveners provided input on this legislation and have sent letters to the sponsors thanking them for taking action on this issue and in support of the legislation.

I am happy that some action is being taken by Congress to address this issue that effects cancer patients throughout the country.

Carboplatin and Paclitaxel are just two drugs on this list. There are other chemotherapy drugs listed as well. Will lives be lost due to this drug shortage? How much worse will the impact be on patients treated at small chemo clinics?How many patients will have their treatment delayed or switched? What about Taxol? Why is there not a shortage of the name brand?

Let us hope that manufacturing rates increase in the near future.

Dee

Every Day is a Blessing!