January 11th, 2007

Counterfeit Drug Trade is Roaring Ahead

Since drug counterfeiting is such an insidious crime — with the evidence being destroyed at ingestion or injection and treatment failure usually chalked up to the underlying disease — I am going to do something I generally don’t do. Reprint a press release almost in its entirety. This came out from the National Association of Boards of Pharmacy a few hours ago, and is chock full of unsettling facts and figures. Counterfeit drugs, a subject I discuss often, affects everyone in the country, for if counterfeits slip into the pharmaceutical distribution system (and with a big profit motive, this is inevitable), they can end out in anyone’s home:

2006 Unprecedented Year of Increased Fake Drug Production, Introduction
into U.S. Drug Supply

WASHINGTON, Jan. 11 /PRNewswireUSNewswire/ — Amid increased concern
over the growing epidemic of counterfeit drugs, the National Association of
Boards of Pharmacy (NABP) issued the following information concerning
worldwide counterfeiting activity. Much of this increased activity is aimed
at pharmacy outlets in the United States. According to a 2006 World Health
Organization report, the current prevalence of counterfeit medicines can
range to over 10 percent of the drug supply globally.
NABP notes that in 2006:

* United States
Nineteen people were indicted in Detroit, Michigan, for importing and
distributing counterfeit products, to include pharmaceuticals. A
portion of the proceeds were used to fund the terrorist organization
Hezbollah.

Eleven people in Georgia, North Carolina, South Dakota and the Central
American nation of Belize were indicted on charges of selling
counterfeit prescription drugs over the Internet. Investigators believe
many of the drugs had little or no medicinal value, and that those
behind the scam netted more than $19 million.

* Canada
One of Canada’s largest Internet pharmacies is selling counterfeit
versions of Lipitor, Crestor, Celebrex and seven other drugs, according
to the Food and Drug Administration (FDA). These counterfeits were
seized en route to American patients.

* Mexico
Eleven tons of counterfeit, expired, stolen, or illegally imported
medicines were reported seized by Mexican authorities in Mexico City,
Guadalajara, Jalisco, and Morelia in November 2006. Six individuals
were arrested and fourteen more are under investigation according to
Mexican news sources.

* South America
It is reported that in underdeveloped countries such as Argentina,
Colombia, and Mexico, up to 40 percent of manufactured pharmaceuticals
are believed to be counterfeit.

* United Kingdom
In July 2005, 70 packs of counterfeit Lipitor, marked with genuine batch
numbers, were found in two separate licensed wholesalers in the UK.
Dutch customs intercepted a consignment of counterfeit Lipitor bound for
Canada and found 10,000 packs in UK packaging. The British Medicines and
Healthcare Products Regulatory Agency (MHRA) recalled the suspect batch
numbers and more than half the 520 packs returned were found to be
counterfeit. Around 2,500 counterfeit packs had already been consumed or
discarded by the National Health Service patients. Days after that
incident came to light a second batch of counterfeit Lipitor was found.

* China
In China, authorities believe that for some drugs, the estimated average
of counterfeit copies can be as high as 50 percent. Chinese police
dealt with more than 4,600 cases involving counterfeit and inferior
goods from January to November 2006, according to the Ministry of Public
Security. One of the most serious cases was the use of tainted drugs
manufactured by Qiqihar No. 2 Pharmaceutical Co., which left 11 people
dead.

* India
20% of medicines sold across India are fake or counterfeit, according to
the Associated Chambers of Commerce of India. Of the 20% fake
medicines, 60% are without active ingredients, 19% have wrong
ingredients while 16% have harmful and inappropriate ingredients, such
as talcum powder.


Also in 2006, NABP introduced a web site to help educate the public
about the dangers of counterfeits and steps they can take to protect
themselves. For more information, visit http://www.dangerouspill.com.

 

January 7th, 2007

Four more indicted in counterfeit Lipitor case

The counterfeit Lipitor investigation from 2003 is apparently still red hot (that is a fake bottle on the right, courtesy of the FDA). An estimated 200,000 bottles were counterfeited.

From the Kansas City Star yesterday:

More defendants were indicted Friday on charges of selling fake Lipitor, bringing to 24 the number charged locally since 2003 for allegedly participating in a wide-ranging counterfeit-drug distribution scheme.

A second superseding indictment handed up by a federal grand jury named six individuals, amending previous indictments by adding four defendants.

The six were allegedly involved in buying and selling prescription drugs in the secondary wholesale market — outfits that buy and sell drugs among themselves and sell drugs to hospitals, clinics, doctors and pharmacies.

The six are accused of selling counterfeit or illicitly imported Lipitor and other prescription drugs in the secondary market. Lipitor, a cholesterol-lowering drug made by Pfizer Inc., is the best-selling prescription drug in the world.

Readers of this space know it is a subject I have covered, and will continue to cover. You can read more about the problems of fake drugs at this link back to my firm’s website.

 

December 28th, 2006

The Sins of Cardinal Health – Putting You at Risk

When New York Attorney General Eliot Spitzer settled two days ago with wholesale drug giant Cardinal Health regarding its trading of drugs with the secondary market, he published what I think is a devastating indictment of the company and how it risked the lives of consumers across the country. Why did Cardinal do this? Fom the AG’s press release is this:

The investigation determined that Cardinal purchased drugs from certain alternate source vendors, despite risks associated with buying from those vendors, to take advantage of higher available profit margins. Cardinal also sold pharmaceuticals to certain customers even in the face of evidence that those customers may have been illegally diverting the drugs outside their intended channels of distribution. (emphasis added)

For those new to the story, this is my post from yesterday on the announcement. While the press release was covered in the newspapers, most (all?) overlooked the specific findings that the AG’s office made regarding Cardinal’s sins. What follows are some of those findings, which give the very distinct appearance to me that Cardinal was being deceptive and/or turning a blind eye to the problem of counterfeits at the time. While problems have now been rectified, it doesn’t excuse the conduct that occurred when it happened.

In reading the AG’s comments below, I noted that when Cardinal employees discuss the risk-benefit issues involved when dealing with the secondary market and suspect medications, they apparently refer to their own risk — as opposed to the risk of patients who may need to take the life saving medications that they are busy trading around.

7. One employee in 2002 wrote an e-mail discussing a newspaper article on a spate of recent counterfeit drug cases. The article quoted one commentator’s view that criminals are bright, rational people “doing the risk-benefit analysis,” and shifting their activities to diverting and counterfeiting prescription drugs. The Cardinal employee wrote, apparently referring to that observation regarding counterfeiters,, “The article mentioned the risk reward ratio of price to penalty when caught.” He concluded: “We obviously need to earn money in this area, but have to manage risk.”

9. At times, Cardinal purchased from sources despite indications that the vendors may have been unsuitable. For example, in January 2004, one employee examined the pedigrees that Cardinal was receiving, and noted suspicious sources in the chain of custody — in his words — firms “which could be bad.” The employee asked that a plan be put together to review those entities. A Cardinal compliance employee indicated that he had already verified that those entities were licensed as wholesalers. That verification was one appropriate step but insufficient. It does not appear that there was any further response to the request for review, nor that the suspect vendors were excluded. The Investigation has shown that some of the entities the employee identified were, as he suspected, engaging in diversion….

10. In March 2004, Cardinal realized that it possessed an anabolic steroid product that customers might perceive as high-risk, although in fact there was no specific evidence of any product integrity issues. It sought to avoid such customer concerns by transferring this product from its trading company, which was known for buying from [alternate source vendors], to its “divisions,” which customers perceived as selling pharmaceuticals purchased from manufacturers. A Cardinal employee sent an e-mail to the head of the Trading Company, noting a substantial inventory in “an anabolic steroid that is on the restricted list due to potential counterfeit. There is plenty of room to pass our inventory to the divisions. What are your thoughts on moving this product to the divisions?’ The reply e-mail instructed simply: “Go ahead and move it.”

11. Cardinal repeatedly sold pharmaceuticals to customers that it knew or should have known were diverting pharmaceuticals. Prior to March 2005, Cardinal made numerous sales of pharmaceuticals to a Nevada company which purported to be a “closed-door” pharmacy that served only nursing homes. In a routine pattern, the Nevada company placed two orders at the same time. One was for products likely to be needed by its stated patient population of nursing home residents, typically in quantities of ones or twos, as would be expected for its needs. The other was for much higher quantities and included products unlikely to be needed by the nursing home residents. Despite this pattern, Cardinal continued to fill the company’s dual orders as described above. Investigation has shown that the company dispensed the products on the small-quantity orders to nursing home residents, and it transferred the products on the large-quantity orders to an affiliated wholesaler for resale on the Secondary Market….

12. Similarly, starting in January 2003, Cardinal was alerted that its customers in the Carrington network of closed-door pharmacies were diverting drugs. One warning came from a Cardinal sales representative who reported visiting the Carrington pharmacies and finding the doors locked, an “Administrative Assistant” on site but no pharmacist, about thirty large boxes awaiting pickup by UPS and delivery to a wholesaler in Kentucky, and purchase orders from a Florida wholesaler with directions to ship to the Kentucky wholesaler. One of the Administrative Assistants explained in detail the process by which the closed-door pharmacy received drugs and sold them to the wholesalers. Cardinal took steps to determine whether the Carrington pharmacies were engaged in diversion, but continued its sales, though at a reduced level, until September 2003. The steps taken by Cardinal, such as seeking assurances from Carrington executives and accepting those assurances, were, in light of other evidence known to Cardinal, inadequate. In December 2003, Cardinal finally severed its business relationship with Carrington after learning from law enforcement that Carrington was under criminal investigation…

13. Cardinal also sold pharmaceuticals to wholesalers who were at the same time on Cardinal’s excluded vendor list — in other words, wholesalers that Cardinal itself deemed sufficiently high-risk that it adopted the policy of never buying product that had passed through their hands. The Trading Company president noted as to one wholesaler in June 2003 that “several things that have happened in the past are making us feel we need to very closely examine our buying” from the wholesaler, while simultaneously noting that “we are fine” with selling to that same wholesaler. In another example from December 2003, the president reported that “we now have been asked by compliance” to add a certain wholesaler to the excluded vendor list, but “We can still sell to them.”

14. Cardinal made “third party” returns to manufacturers on behalf of other wholesalers regardless of where the wholesaler had purchased the product. As a former Cardinal employee testified: “[I]t wasn‘t worth our while to research whether we had [originally] sold it to the alternate source or to this third party or not.” Such practices can support the Diversion Market by giving unscrupulous customers an incentive to divert drugs and then “return” them for full credit….

One can only hope that the folks responsible have long since been fired. If not, then I think top management must have been complicit in the conduct.

Links to this post:

more secondary drug trading fallout
over a year ago drug wholesaler cardinal health announced it would stop trading drugs in the secondary market. such trading was a lucrative sideline for cardinal, offering the potential for much higher margins than the traditional
posted by David E. Williams of the Health business blog @ January 04, 2007 5:49 PM

 

December 27th, 2006

Cardinal Health Settles Drug Inquiry with New York for $11M

Cardinal Health, one of the “Big Three” of the drug wholesaling business, has settled New York’s investigation against it for $11M and agreed to reforms of its business practices. Cardinal is ranked 19th on the Fortune 500 list of America’s largest corporations.

The underlying problem dealt with the company’s purchase and sale of drugs out of the “secondary market,” instead of buying them directly from manufacturers. This gray market in drugs involved some 6,000+ wholesalers as of 2005 when New York’s investigation began, and before changes started to sweep through the industry. Many of those changes I had previously documented on my Counterfeit Drug Resource Page.

The existence of so many secondary wholesalers — who are licensed by a hodgepodge of regulations that vary from state to state — led some to buy and sell pharmaceuticals without knowing exactly where they had been and who had owned them in the past. This opened a gaping hole for counterfeit medications to leak into the legitimate drug supply system. The purchase of such mystery medicines was widely condemned and led to changes by major wholesalers in 2005.

From the press release out of the office of New York Attorney General Eliot Spitzer:

Secondary market trading is not illegal on its face, but can create opportunities for the introduction of unreliable drugs, including counterfeits, into the marketplace. In recent years, there has been an increase in the number of cases of counterfeit drugs in the American supply chain. Secondary market trading also can create an opportunity for companies to divert drugs from their intended distribution channels. Diversion into the secondary market, often to take improper advantage of manufacturer discounts, can begin a series of trades from wholesaler to wholesaler that makes it difficult to trace the origin of a drug and impossible to ascertain its authenticity.

The investigation determined that Cardinal purchased drugs from certain alternate source vendors, despite risks associated with buying from those vendors, to take advantage of higher available profit margins. Cardinal also sold pharmaceuticals to certain customers even in the face of evidence that those customers may have been illegally diverting the drugs outside their intended channels of distribution.

A review of the AG’s findings, which does not seem to appear in newspaper accounts of this settlement, represents in my view a devastating indictment of the conduct of Cardinal Health, which appeared to act in a reckless disregard for the safety of consumers. This will be the subject of a follow-up post.

As per the AG’s office, Cardinal will pay $3 million to New York State, $7 million to a non-profit health research corporation called Health Research, and $1 million to the attorney general’s office to cover costs of the investigation. But wait… there’s much more…it appears it isn’t just about money but about forcing better business practices:

In addition to adopting the Wholesaler Safe Product Practices, Cardinal has agreed that in the regular course of its business it will:

— Buy pharmaceuticals directly from manufacturers and not on the secondary market from alternate source vendors;
— Sell pharmaceuticals only to wholesalers who have certified their compliance with the Wholesaler Safe Product Practices, and have agreed to allow audits of those certifications;
— Adopt “know your customer” provisions and monitor for customer diversion; and
— Hire an external auditor to conduct periodic reviews of its compliance with the settlement.

As I wrote on November 27th , I was one of the people the attorney general had dropped a subpoena on, for the records I had obtained and created in my own investigation regarding the counterfeit drugs taken by a Long Island teenager, Tim Fagan, after he had undergone an emergency liver transplant. It’s nice to see the investigation has paid dividends for New Yorkers, not just in financial recovery, but in a safer pharmaceutical supply chain.

Links to this post:

more secondary drug trading fallout
over a year ago drug wholesaler cardinal health announced it would stop trading drugs in the secondary market. such trading was a lucrative sideline for cardinal, offering the potential for much higher margins than the traditional
posted by David E. Williams of the Health business blog @ January 04, 2007 5:49 PM

 

December 13th, 2006

Counterfeit Drug Legislation Stalls in Court

Passed by Congress in 1987 and signed into law in 1988, critical portions of the Prescription Drug Marketing Act are still not in effect. Specifically, those parts that deal with certain drug wholesalers maintaining a “pedigree” for the drugs they trade. But the FDA had finally decided after all these years that December 1st of this year would be the magic day.

I discussed some of this back on December 1st when some secondary wholesalers — those that are not “authorized” wholesalers, for whom the strict pedigree provisions don’t apply –had obtained temporary relief in court preventing the PDMA from finally being implemented . This is important because accurately tracking the pedigree (or chain of custody) of a drug is a major way to keep control of the supply chain. This is critical to making sure counterfeit drugs don’t leak into our regular drug channels, and thereby into your local pharmacy.

Now a federal judge has ruled on this in favor of the secondary wholesalers, thereby staying the provisions of the law. Since two blogs have already covered this, I won’t re-invent the wheel and will direct you to them:

Both Juvan’s Health Law Update and Adam Fein’s Drug Channels had long discussions on the issues in their blogs on December 10th.

–ET