OT:Pharmacies 'flunked' FDA test

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Pharmacies 'flunked' FDA test

2003 analysis: 34 percent of drugs from compounders misformulated

By peter korn

The Portland Tribune, May 11, 2007 (4 Reader comments)

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A 2003 Food and Drug Administration analysis of drugs supplied

by " compounding pharmacies " that sell over the Internet found that

34 percent of the drugs were not formulated as advertised.

Most of the 29 sampled drugs that failed the FDA standards were much

less potent than stated on labels. But one of the samples failed

tests for not containing the medication it was supposed to have, and

another failed a contamination test.

The 34 percent failure rate on the drugs' composition compares with

a failure rate of less than 2 percent for drugs produced by major

manufacturers, according to the FDA study.

Drugs from manufacturers are regulated by the FDA and routinely

sampled. Drugs produced by compounding pharmacies — a designation

traditionally reserved for small pharmacies that mix medications not

available from manufacturers — do not require sample testing by any

government agency.

The safety of drugs produced by large compounding pharmacies, which

often sell via the Internet, has become spotlighted since the deaths

in late March and early April of two Portland residents and a woman

from Yakima, Wash.

All were injected with a poisonous batch of the drug colchicine. A

large batch of the drug was supplied to the Southwest Portland-based

Center for Integrative Medicine by ApothéCure Inc., a Texas-based

compounding pharmacy.

Because it calls itself a compounding pharmacy rather than a

manufacturer, ApothéCure does not have to abide by FDA regulations,

even though it sells large batches of drugs nationally that also are

made by drug manufacturers.

In fact, a physician at the now-closed Center for Integrative

Medicine said the clinic used colchicine from ApothéCure for

intravenous treatment of back pain because it was cheaper than the

same drug from a manufacturer.

Pharmacy experts say that companies such as ApothéCure can afford to

sell more cheaply because they do not have to bear the costs of

meeting FDA requirements for equipment and personnel. Some believe

compounding pharmacies that sell over the Internet should be

considered manufacturers and be subject to FDA regulation.

The FDA analysis of the drugs from compounding pharmacies was a

small sample, but may be the only test done by a governmental agency

that compares the drugs of compounding pharmacies with those of

manufacturers, according to Dr. Leonard Wartofsky, an

endocrinologist at Washington Hospital Center in Washington, D.C.,

and president of the Endocrine Society, a national physicians'

organization.

" It's a random sampling done by a reputable organization with strict

standards, and the compounds flunked the test, " Wartofsky said.

Committee looks at problem

Wartofsky recently testified before the U.S. Senate Special

Committee on Aging, which is looking into compounding pharmacies and

unregulated alternative medicines called bioidentical hormones that

are produced by the pharmacies.

" I might expect randomly one might flunk a test, two perhaps, "

Wartofsky said in an interview. " But my gosh, it certainly rings an

alarm bell that so many are not meeting standards, that this is a

generalized problem. "

Oregon Sen. Gordon , the ranking Republican member on the

Committee on Aging, said in an interview Wednesday that he believes

that the committee is going to take action to ensure better

regulation of large compounding pharmacies.

began looking into compounding pharmacies before the details

of the colchicine poisonings became public.

In April, the committee held a hearing to look at the proliferation

of bioidentical hormones, which commonly are produced and sold by

compounding pharmacies as alternatives to synthetic hormone

medications for women in menopause. But the compounding pharmacies

themselves soon became a focus of the committee.

At the hearing, held up a bottle of progesterone cream that

his staff had bought without a prescription from a compounding

pharmacy over the Internet. He displayed a poster from the

compounding pharmacy's Web site that made the claim " this product …

will greatly decrease your risk of breast cancer. "

also produced a warning letter from the Federal Trade

Commission that had been sent to the company selling the cream. The

letter told the company it needed to stop the false advertising; the

letter had been issued to the supplier years before.

also noted at the hearing that in 2005, the FDA and FTC sent

out 34 similar warning letters to online compounding pharmacies and

resellers of drugs. According to , 32 of the 34 companies that

received FTC warning letters are still in business and still selling

drugs with false advertising.

Where to draw the line?

said the April hearings produced testimony that convinced him

that more needs to be done. Asked the most important discovery, he

said: " How much is going on without any regulation. The specific

claims that are being made without any scientific basis and

candidly, as colchicine demonstrates, this is going on with pharmacy

compounding at a level that is alarming and maybe deadly. "

But establishing a workable definition for when a compounding

pharmacy crosses over and becomes a manufacturer will be one of the

most difficult tasks facing and others who would add

regulations for compounding pharmacies.

All pharmacies are licensed to compound, or mix their own drugs. But

most pharmacies choose to simply dispense drugs produced by

manufacturers. A few pharmacies — compounders — still prepare

medications on their own, usually niche products that are not

offered by drug manufacturers.

But companies such as ApothéCure have grown up with the Internet,

selling large batches of medicine for office use by medical

practitioners.

" The definitions need to be spelled out, " said Wartofsky, who

emphasized he has no problem with small compounding pharmacies that

supply individualized prescriptions.

" The state pharmacy boards need to not only have greater power, but

put some teeth into that power so they can do something about these

compounding pharmacies. They are not supervised; they can do

anything they want. It's back to the Wild West of the 1800s with

snake oil. "

said he has asked the Congressional Research Service to

prepare a report that will guide legislation. The report will look

at regulations and enforcement for compounding pharmacies in all 50

states. Among the topics he said would be addressed will be adverse-

event reporting.

Most states, including Oregon, do not require compounding pharmacies

to report any side effects suffered by people using their

medications. Under FDA rules, manufacturers are required to report

adverse events that result from use of their drugs.

The report is due back to 's committee within a few months.

said soon after receiving the report his committee will take

action.

" Something will happen, " he said. " When we get the data we will put

together legislation. "

peterkorn@...

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Suit seeks $2 million in drug death

The family of a Portland woman believed to have been poisoned by a

bad batch of a controversial drug filed suit in federal court

Wednesday against the Texas company that made the drug.

The lawsuit seeks $2 million in damages but leaves open the

possibility that the family could ask for a larger award.

Margrit Long was one of three area patients who died shortly after

receiving injections of a drug called colchicine supplied by the now-

closed Center for Integrative Medicine in Southwest Portland.

According to toxicology reports performed for the Oregon medical

examiner, the drug administered to all three came from a batch that

was mistakenly mixed to be 10 times as potent as labeled — strong

enough for one injection to kill.

The batch came from ApothéCure Inc., a Texas drug supplier that

calls itself a " compounding pharmacy " but operates on a national

scale, supplying drugs to patients and health professionals through

an Internet-based business.

The suit was filed on behalf of Long's family by Spellman,

Long's daughter, who lives in Lake Arrowhead, Calif. Long's two sons

live in the Portland area.

The defendants include Osborn, president of ApothéCure, and six

corporations that make up the ApothéCure family of companies in

Dallas.

Wednesday, Osborn released a statement acknowledging ApothéCure's

role in the poisonings.

" We are heartbroken that our policies and procedures were apparently

not followed in the production of one batch of colchicine, " the

statement said. " This breach in protocol apparently resulted in the

batch being more potent than was indicated on the label. "

The Long family's Portland attorney is Tom Powers, who specializes

in pharmaceutical litigation. " From my experience this looks like a

case where something went terribly wrong, " Powers said.

" The purpose of filing the lawsuit is to figure out what went wrong,

get justice for the families, hold these defendants accountable and

prevent something like this from happening again, " he said.

Powers said the requested $2 million in damages might be just a

starting point.

" If there is evidence that there was reckless conduct, then punitive

damages may very well be the best remedy, " he said.

— Korn

Reader comments

Re: Pharmacies 'flunked' FDA test

In 2003, Senators Bond and held a Senate hearing about

pharmacy compounding as a result of the incident in

Missouri. Also in 2003, the Missouri Board of Pharmacy implemented

random statewide testing of compounded drugs. The results:

" A total of 410 products have been tested since the inception of the

program in November 2003. A total of 81 compounds collected from 59

pharmacies tested outside acceptable limits, representing a failure

rate of 19.8 percent. " (Missouri Department of Economic Development

News Release-April 5, 2005.)

In February of 2007, the Ohio Board of Pharmacy disciplined a

pharmacist who had distributed a minimum of 100 nebulizer medication

prescriptions that tested as sub-potent, with some of the

medications having as little as 27% of what was labeled. There was

fungal contamination found in 23 prescriptions. Were all the

patients and prescribers notified? Was anyone harmed by using what

they thought were safe, effective, sterile nebulizer medications

when in fact patients were taking subpotent or contaminated

medications?

The Ohio State Board of Pharmacy fined the pharmacist $1500.00,

required her to take additional training in sterile compounding and

work in a position under a supervisor until she has been approved by

the State Board to do sterile compounding without supervision.

I applaud Senator 's actions and encourage all members of

Congress to step up and introduce legislation that protects

patients. We need a national solution to this nationwide problem

today - before one more patient is harmed.

" Fusco- "

(Not verified)

Fri, May 11, 2007 at 05:15 AM

Lets keep this in perspective...

In the compounding debate, follow the money....

Big pharmaceutical companies spend tens of millions of dollars every

year to influence members of Congress. A recent report that was

issued by the Center for Public Integrity showed just how big

Pharma's lobbying efforts have become.

According to their report, drug companies and their trade groups

spent $155 million from January 2005 through June 2006 and employed

about 1,100 lobbyists to do their bidding in each of the past two

years (giving the drug companies two lobbyists for every one member

of Congress!).

Wyeth Pharmaceuticals, in their effort to limit or eliminate the

compounding of bioidentical hormones (a safer alternative to hormone

replacement therapy than Premarin or Prempro), is leading the

effort. Wyeth is supposedly concerned about the safety of

compounding but fails to mention the disasterous side affects of

Prempro.

In an National Institute of Health study of 8,000 women who

took " Prempro " , a combination of the drug, Premarin, and synthetic

progestin (medroxyprogesterone acetate). Prempro was supposed to

enhance health, not endanger it, but five years into the eight-year

study, the monitoring committee put a stop to it, and announced that

the side effects weren't worth the risk.

Blood clots increased 100%, stroke increased 41%, heart attacks

increased 29%, heart disease increased 22%, and most ominously, the

risk of invasive breast cancer increased 26%. Prempro now has the

dubious distinction of increasing the risk of all of the leading

causes of death in older American women.

So, when it comes to compounding, lets keep this incident in

perspective.

" Soule "

(Not verified)

Fri, May 11, 2007 at 11:25 AM

Re: Pharmacies 'flunked' FDA test

Follow the money--Indeed! The typical profit margins on compounded

drugs may exceed 99%--these drugs are made cheap and sold at

extraordinary prices, considering they do not meet federal

requirements for establishing safety and effectiveness and they are

not manufactured according to federal requirements. The fact that

they do not meet federal requirements is not disclosed in

advertising and marketing materials nor on prescription labels

allows the drugs to infuse the market without detection: this

facilitates the growth of unapproved drug markets and expands

profits for pharmacies, however, the model generally conflicts with

basic standards of pharmacy professionalism which are based in part

on the dissemination of important drug safety information.

If you are a patient who may have a procedure in a physician's

office, you should ask if the drugs that are being dispensed to you,

or infused or injected into your body are guaranteed to be pure,

potent and sterile according to federal standards. If they are

compounded, there is no guarantee they are. Even your doctor may not

fully appreciate the distinction between a compounded drug and an

FDA-approved one, and there is no requirement that a pharmacy

disclose this information to you or your doctor.

" Don't throw the baby out with the bath water " relies on a general

understanding the water is dirty and needs to be disposed of—in the

case of compounding, the fact that there may be a danger is being

withheld from doctors and patients—caveat emptor (doctor and

patient, beware).

" Tara Gates "

(Not verified)

Fri, May 11, 2007 at 02:56 PM

Re: Pharmacies 'flunked' FDA test

I am truly sorry to see such poor performance on the part of

compounding pharmacies. I would, however, like to see all of the

study data to understand exactly what was studied and how the study

was conducted. Every pharmacy I have ever worked in has done some

compounding, and as far as I know almost every pharmacy in the

United States does at least a little compounding, so this really is

an important issue for anyone that takes medication. If pharmacies

stopped compounding medications, then some people would go without

their meds because certain drugs are not manufactured by drug

companies. Before I became a pharmacist, I was an industrial

chemist. I have an undergraduate degree in chemistry and a graduate

degree in condensed matter physics/polymer chemistry. I really do

not understand why the results obtained in industry are not being

obtained in pharmacies unless non-pharmacists are doing the

compounding. Of course, when I worked in industry technicians did

most of the bench work and the scientists provided oversight. It is

true that pharmacists are not chemists, but there is more than

adequate training in pharmacy school to allow a pharmacist to

expertly compound high quality medications from " raw ingredients " .

Maybe there is not enough oversight by the pharmacists. Maybe the

problem is driven by finances. Whatever the problem is, I hope it

starts to be addressed because most of the IVs you might get in the

hospital are compounded by a pharmacist or under the supervision of

a pharmacist. I do not want to use any medications that have not

been made according to some sort of nationally recognized compendia.

Pharmacists, in my opnion, are generally very well paid. They are

not paid for nothing - they should be making sure the policies and

procedures followed in their pharmacies are enhancing health and not

harming it.

" Alaskan Pharmacist "

(Not verified)

Sat, May 12, 2007 at 09:26 PM