The Heparin Disaster

Bad Chinese Heparin Supplier Cited by FDA Again

2009-05-14T10:21:00.004-04:00

Despite the deaths of hundreds of Americans last year from tainted Chinese heparin, Scientific Protein Laboratories (“SPL”) has still not cleaned up its act and has been cited again this month for violating safety regulations.

SPL supplied the component ingredients in the bad heparin, called “active pharmaceutical ingredients” ("API") to Baxter from its facility in China. However, despite Baxter and SPL's representations to the public that they were taking great care to assure the safety of their drugs, both companies knew that the Chinese facility had never been inspected by the FDA or any other governmental agency.

Last year, upon investigating the cause of the deaths, the FDA discovered the existence of the Chinese facility. When the International Compliance Team for the U.S. FDA performed an inspection of the Chinese facility from February 20 – 26, 2008, multiple and severe violations were found, including, but not limited to, the lack of any assurances that the processing steps used to manufacture heparin were capable of effectively removing impurities.

As a result, the FDA issued a “Form 483” to SPL last year. A Form 483 is referred to as “Notice of Inspectional Observations.” The 483 is issued by an FDA field investigator after an on-site inspection of a facility and documents significant and serious violations from regulations called “Good Manufacturing Practices” (“GMP”) regulations. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations protect the consumer from purchasing a product which is ineffective, dangerous or contaminated.

After hundreds of Americans died from bad heparin supplied by its facility, you would think that SPL (who is now being defended by Baxter in the ongoing litigation), would have learned its lesson. You would think that the company would insist that its facilities strictly adhere to safety regulations to avoid something like this happening again. Unfortunately, such is not the case.

The FDA recently issued another Form 483 for SPL’s United States plant in Waunakee, Wisc. (See May 13, 2009, FDAnews Drug Daily Bulletin “Scientific Protein Laboratories Gets Form 483 for Heparin Plant,” Vo. 6 No. 93.) The FDA cited six violations of GMP regulations, including for example, incorrect or inadequate data and reports, and failure to follow safety protocols, including the cleaning of tanks used in the manufacture of heparin.

SPL’s ongoing and callous disregard for safety procedures is an absolute insult to every victim of the heparin disaster. The fact that Baxter is defending this company and asking that both itself and SPL not be held responsible for the deaths of innocent men, women and children, is likewise sickening. These companies must be held responsible. There must be consequences when companies balatantly ignore safety regulations, thereby sacrifing human lives for corporate profit. If not, as evidenced by SPL's refusal to learn from the heparin tragedy, history is bound to repeat itself.

The Games Drug Companies Play

2009-05-08T09:44:00.004-04:00

Elsevier, the publisher of many medical journals relied upon by experts in drug litigation, made a chilling announcement yesterday:

Philadelphia, PA, 7 May 2009 - Elsevier, one of the world’s leading publishers of scientific, technical, and medical (STM) information products and services, announced today that Michael Hansen, CEO of Elsevier’s Health Sciences Division, issued the following statement in light of recent allegations of improper Australia based sponsored journal publication practices between 2000 and 2005:

“Elsevier prides itself on operating its business in the most ethical, honest and transparent manner possible. We have been stewards of the scientific record for more than 125 years and we take our role in advancing medical and scientific research seriously.

It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures. This was an unacceptable practice, and we regret that it took place.

We are currently conducting an internal review but believe this was an isolated practice from a past period in time. It does not reflect the way we operate today. The individuals involved in the project have long since left the company. I have affirmed our business practices as they relate to what defines a journal and the proper use of disclosure language with our employees to ensure this does not happen again.

We will continue to partner with all scientists and clinical investigators, including those in the pharmaceutical industry, to help communicate the findings of high-quality, peer-reviewed medical research. We have strict disclosure rules in place so that readers are aware of any financial interests behind a specific article or journal, or when entire compilation products are created for pharmaceutical marketing purposes.

I understand this issue has troubled our communities of authors, editors, customers and employees. But I can assure all that the integrity of Elsevier’s publications and business practices remains intact.”

The AP reported that "Those publications included one titled The Australasian Journal of Bone and Joint Medicine, which heavily favored Merck & Co.'s osteoporosis drug Fosamax and the painkiller Vioxx."

Why is this so troubling? For a number of reasons. First, because it shows how invidious the big drug companies are in pushing their products, even when they know or have reason to know that those drugs have dangers which have not been fully disclosed.

Second, because medical journals are used by expert witnesses in cases such as the Heparin Litigation to support claims or oppose claims that a particular drug causes harm, or that it has been improperly marketed or lacked necessary warnings.

In essence the drug companies use their massive propaganda machine to push doctors into prescribing their drugs and to prevent those who are injured or killed by the drugs to obtain fair compensation.

In Vioxx Merk paid out over $4.6 billion to settle the cases, even after they had succeeded in defending many of the cases at trial. Articles in medical journals about the efficacy of Vioxx and the risks of harm were relied upon by experts for both sides in those trials.

Similarly, in the Heparin Litigation, many of the articles that have been written to date on contaminated heparin include authors whom we know are on the payroll of Baxter. We have made that discovery from a review of the confidential documents produced by Baxter, even though the articles themselves fail to make those disclosures.

The truth can only be learned through vigorous, demanding and diligent review of documents and careful depositions of witnesses. It is possible that this latest revelation could lead to further challenges of the Vioxx settlement, particularly if any experts relied upon the challenged articles in their testimony.

We will continue to vigorously pursue Baxter and the other defendants to hold them responsible for the harm caused by the dirty Chinese Heparin they sold across the continent. On Monday we have a hearing to determine a trial schedule. The papers we filed yesterday asked the Court to set the first cases for trial in the Spring of 2010.

FDA Pushed for Answers Regarding Bad Chinese Heparin

2009-05-06T15:35:00.003-04:00

Like many Americans, including the families of hundreds of innocent victims killed from tainted Chinese heparin last year, Rep. Joe Barton, (R- Texas) is dissatisfied with the lack of information from the FDA regarding the heparin debacle.

Barton, (the ranking member on the House Energy and Commerce Committee), has asked the investigative arm of Congress, the Government Accountability Office, to investigate the FDA’s response to the heparin debacle. He has also sent a letter to Acting FDA Commissioner Joshua Sharfstein, demanding that the FDA turn over any databases relating to their investigation. (See 05/06/09 Article from NASDAQ, Jared A. Favole, “Rep. Barton Presses FDA for Information about Tainted Heparin.”)

An unidentified staffer for the Energy and Commerce Committee is quoted as saying, “We don’t seem to be any further along a year later from understanding [the heparin debacle]. What are they doing about it? Is this an acceptable practice in China?”

Last year, Barton also sent a letter to the former FDA Commissioner, Dr. Andrew von Eschenbach, seeking answers on why the agency took six months to confiscate 11 tainted batches of heparin from Celsus Laboratories (located in Cincinnati, Ohio) even though an inspection in April found that the company's recall was inadequate. (See Dec. 15, 2008 Blog, “Rep. Barton Questions FDA’s Six Month Delay in Seizure of Tainted Heparin.”) At the time, FDA officials said they could not give details because of "an ongoing investigation."

While we applaud these continuing efforts by Congress to get answers for the victims of the tragedy, similar inquiry should also be made of the responsible drug companies, including Baxter. It was Baxter who decided to purchase the cheaper, bad Chinese heparin from a Chinese plant that it knew had not been inspected by the FDA. Why? Corporate Greed. While the FDA certainly has a duty to provide information to the American public, we should not loose sight that it is ultimately the drug companies, including Baxter, who are responsible for ensuring the safety of their supply chains.

Barton wants the FDA to respond to his letter within two weeks. We will continue to keep you updated as to any response from the FDA.

Baxter Files its Trial Proposal - Seeks to delay trials until 2011

2009-05-04T13:46:00.006-04:00

Late last week Baxter filed a Scheduling Proposal with Chief Judge James G. Carr here in Toledo, seeking to delay any trial in the Heparin Disaster litigation until June 1, 2011. We will be filing our response later this week, and will present argument on the issue in a hearing set for May 11th in Cleveland.

In our filing we will try to push for a quick trial date so that the victims of the Heparin Disaster will get their day in court sooner rather than later.

Sadly the goal of Baxter and other big pharma companies whose drugs cause harm typically follow this same pattern of delay: Delay the date of reckoning, delay the date of payment as long as possible, and then pay as little as possible to those you have injured. The only tool we have to bring these big companies to justice is the hammer of a jury trial. So it is our task to prepare for that trial as quickly and diligently as possible.

While we now have received a million pages of documents from Baxter and SPL, almost all have been marked confidential. This prevents us from sharing the content of those documents until the time of trial.

What we can say is that there is nothing good in these documents for Baxter or SPL.

Once trials begin they will be primarily wrongful death cases. The most serious harm caused by the contaminated heparin were wrongful deaths of people who were undergoing dialysis therapy or heart surgery between October 1, 2007 and April 1, 2008. We expect that most of the early trials will focus on cases that meet these criteria.

If you lost a loved one during this period of time who was undergoing dialysis or heart surgery you should immediately seek legal counsel. Some states have one year statutes of limitation while other states may have 2 years, which means that if a claim isn't filed promptly it can be time barred.

Baxter Releases Live Avian Flu Virus

2009-04-29T19:26:00.006-04:00

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Baxter International, the company that brought us contaminated Chinese heparin, has struck again. The Toronto Sun reported earlier this year that it released live flu virus material in Austria.

The World Health Organization is closely monitoring the situation. The contaminated product was a mix of H3N2 seasonal flu viruses and unlabelled H5N1 live avian flu viruses. The viruses could have combined to create an even more dangerous hybrid.

People familiar with biosecurity rules are dismayed by evidence that human H3N2 and avian H5N1 viruses somehow co-mingled in the Orth-Donau facility. That is a dangerous practice that should not be allowed to happen, a number of experts insisted.

Accidental release of a mixture of live H5N1 and H3N2 viruses could have resulted in dire consequences.

While H5N1 doesn’t easily infect people, H3N2 viruses do. If someone exposed to a mixture of the two had been simultaneously infected with both strains, he or she could have served as an incubator for a hybrid virus able to transmit easily to and among people.

That mixing process, called reassortment, is one of two ways pandemic viruses are created.

Amazingly, Baxter refused to reveal information about how the accident happened because of fear of revealing “trade secrets.” According to the Toronto Sun:

Earlier this week [Baxter spokesman Christopher] Bona called the mistake the result of a combination of “just the process itself, (and) technical and human error in this procedure.”

He said he couldn’t reveal more information because it would give away proprietary information about Baxter’s production process.

The cavalier attitude of Baxter towards the release of live flu virus is the same attitude we see in the Heparin case. Baxter failed to secure its supply lines, failed to adequately test, failed to adequately inspect, and when the contamination was discovery, failed to perform an adequate recall. In its quest to grasp the low hanging fruits and profits it ignores the safety of those it should be protecting. It is the same attitude that has plagued Baxter for decades.

For some very interesting history of Baxter International, go to Wikipedia and read the history of Baxter International.

Grassley, Kennedy Introduce Bill to Protect Against Contaminated Imported Drugs

2009-04-27T10:13:00.006-04:00

Sens. Chuck Grassley (R-Iowa) and Edward Kennedy (D-Mass.) introduced new legislation in Congress last week that would broaden the FDA’s inspection and enforcement authority with respect to foreign drugs and medical devices. To view the press release on the proposed legislation, click here.

This legislation, referred to as “The Drug and Device Accountability Act of 2009,” would give the FDA money to conduct foreign drug plant inspections. As stated by Sen. Grassley, “An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn’t know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year. Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work.”

The proposed legislation would also give the FDA the power to detain products from foreign plants when inspectors believe that a drug, (such as the dirty Chinese heparin that recently killed hundreds of Americans), has been adulterated. This is important because the FDA currently has no alternative, but to rely on the overworked and unfunded U.S. Customs to handle the actual seizure of suspect imported goods.

The bill would also give the FDA the power to issue subpoenas allowing the agency to obtain internal business records from careless drug manufacturers who ship production of their drugs overseas in order to increase corporate profit and avoid regulation meant to protect the American public. As discussed previously in our May 21, 2008 blog, “FDA Needs Subpoena Power,” without this ability, the agency is powerless to obtain internal business records from a negligent company who has allowed contaminated drugs to be sold, (such as Baxter who sold the dirty Chinese heparin from a foreign plant that Baxter knew had never been inspected by the FDA or any other governmental agency).

The FDA is one of the few Federal agencies that currently lacks subpoena power. As previously noted by Rep. Bart Stupak, (Chairman of the investigations panel of the House Commerce Committee), in a letter last year to the former FDA Chief, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.”

Finally, the proposed legislation would also require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications.

To fund the new powers, the bill would levy fees on plant inspections, thus putting the cost on the drug manufacturers who decide to send production overseas.

This regulation would likely have prevented the Heparin debacle and saved the lives of hundreds of innocent Americans. As such, we commend and support this important legislation.

Sherrod Brown speaks out for Heparin Victims

2009-04-23T15:23:00.005-04:00

Ohio Senator Sherrod Brown struck a blow for victims of dirty Chinese Heparin yesterday in a speech in our nation's capital. Speaking before the Washington International Trade Association and the George Washington University Elliot School for International Relations, Senator Brown decried the importation of cheap drugs:

Our enormous trade deficit has resulted in our nation not only importing goods and services, but also importing the dangerous safety standards of our trading partners.
In Toledo, Ohio, patients died after taking contaminated Heparin to treat their heart conditions. The manufacturer of Heparin had outsourced the making of the drug, and as a result, did not know where the contamination occurred.
The patients in Toledo, or the factory workers in Reynosa, or the meatpackers in Nebraska illustrate that continuing our trade direction is not a ringing endorsement of our trade agenda. Their stories represent a continuation of a policy of broken promises. [Link to full text of speech]

I discussed the Heparin Disaster with Senator Brown last year in Toledo. He clearly heard the concerns of the victims of big pharma. Senator Brown understands that the big corporations like Baxter Healthcare put profits over people.

We have now received about one million pages of documents from Baxter. These documents show that Baxter went to China for its heparin because it could save a few dollars on its raw material costs. Baxter knew the Chinese facility had never been inspected by the FDA. It knew that there were no inspections being performed on the heparin workshops and consolidators.

Baxter showed reckless indifference even after the contamination was brought to light. We are now learning that Baxter was being criticized by the FDA in September of 2008 for an inadequate recall.

The more we learn, the worse the story. We will continue to uncover the unsavory details and fight in the courtroom for the victims. We ask you to all support Senator Brown as he fights for us in the halls of Congress.

Two Chinese Heparin Suppliers Cited by FDA

2009-04-19T21:11:00.002-04:00

The FDA just cited two Chinese-based drug suppliers, Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co, who manufactured and sold at least 19 lots of contaminated heparin to the U.S. in 2008, despite the fact that the heparin was supposed to be quarantined. (See 04/18/09 Wall Street Journal Article, “FDA Cites Two Chinese Heparin Makers.”) To read the FDA’s letter to Qingdao click here. To read the FDA’s letter to Shanghai No. 1 click here.

The heparin was tainted with over-sulfated chondroitin sulfate (“OSCS”), the same contaminate that has been linked with numerous U.S. deaths.

During the FDA’s inspection of these companies, the FDA found “significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs.” Further, one of the drug suppliers, Shanghai No. I Biochemical, was also was found to have lied to the FDA about the manufacture of its heparin. Specifically, the FDA found that the Chinese drug supplier “used two other manufacturers to produce heparin sodium, failed to notify FDA of this manufacturing arrangement, and affirmatively represented that ‘no contract firms are involved in the manufacturing of the drug substance, Heparin Sodium USP, that is the subject of th[e] Drug Master File.’”

PREEMPTION REJECTED!!

2009-03-04T12:05:00.005-05:00

As addressed periodically on this blog, powerful drug companies such as Baxter, have advocated for complete immunity from the majority of suits involving unsafe medical drugs and devices under a legal concept called “preemption.” Specifically, they have argued that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA.

It looked like for a time, the drug companies were winning in this battle against victims harmed by their defective drugs. This was particularly true a little over a year ago in February 2008, when the United States Supreme Court severely curbed the rights of injured victims in the case of Riegel v. Medtronic, which held that the Federal Food, Drug and Cosmetic Act (FDCA) preempts state-law claims seeking damages for injuries caused by medical devices with premarket approval from the FDA. (The harsh effects of this decision are now being sought to be reversed in a bill sponsored by Congressmen Pallone and Waxman.)

The United States Supreme Court then accepted a case, Wyeth v. Levine, that involved the labeling of a medical drug. Until this morning, the case had not been decided.
In the case, Diana Levine, a professional musician, went to the hospital to treat a migraine headache. However, after being injected with a drug manufactured by Wyeth, she was left with injuries that led quickly to the amputation of her right arm, harming her profession and lifelong passion to be a musician. The drug, Phenergan, was given to Ms. Levine using a method of administration that was permissible under Wyeth’s label instructions. However, Wyeth knew for decades that this method increased risk of contact with arteries and serious injuries, and specifically chose not to warn the medical community and the public of this danger.

After a trial in the case, a Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein. However, the drug company appealed and, backed by the Bush administration, argued that since the FDA had approved the drug’s labeling instructions, victims such as Ms. Levine are barred (i.e. “preempted”) from being able to hold them accountable, even where the company knew its warnings were not adequate.

In a 6-3 decision released this morning, the United States Supreme Court rejected Wyeth's claim that federal approval of its drug should have shielded the drug company from lawsuits like the one filed by Ms. Levine.

This is an important victory, particularly for the injured Americans who will not be denied their constitutional to seek and obtain justice in a court of law.

A copy of the decision is available by clicking here.

FDA Scientists Report Corruption to President Obama

2009-02-17T17:21:00.004-05:00

Last month, a group of nine FDA scientists wrote to the Obama transition team reporting widespread managerial misconduct in a division of the Food and Drug Administration. Specifically, in a letter written on FDA Center for Devices and Radiological Health letterhead, the FDA scientists complained that agency managers use intimidation to suppress scientific debate, leading to the approval of questionable medical devices that may not be safe for the American public.

Various quotes from the letter provided to The Associated Press by a Congressional official, include:

-"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."

-"[Top FDA officials] committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along."

-"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts."

-"Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

-"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around."

This letter continues to confirm that the FDA, whose duty is to protect the safety of the American public, is in desperate need of repair. It also reflects the power of large medical drug and device companies, who care more about profits than people, to influence the highest levels of government. We continue to support lawmakers who are seeking to overhaul the current FDA and once again restore confidence in the agency, so that catastrophic failures such as the heparin debacle will not happen again.

New York Times Reports on Concern Over Drugs Produced Abroad

2009-01-21T15:21:00.003-05:00

According to a recent article in the New York Times, "experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States." (Gardiner Harris, The New York Times 01/19/09 “Drug Making’s Move Abroad Stirs Concerns.”)

In recent years, pharmaceutical companies like Baxter (who sold the majority of contaminated heparin that resulted in numerous U.S. deaths), have imported drugs and/or shipped production oversees in order to increase corporate profit and avoid regulation. Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the FDA in 2007, the article reports that only 13 percent were in the United States. Forty-three percent were in China, and 39 percent were in India.

The article further reports that since drug makers often view their supply chains as trade secrets, the true source of a drug’s ingredients can be difficult or impossible to discover. Indeed, the FDA cannot even identify how many foreign entities ship drugs into the U.S.

As a result, and as made clear from the recent heparin contamination, oversees drug production with little or no government oversight, leaves Americans at risk for tainted drugs. We continue to support Ohio Senator Sherrod Brown, (who has held hearings on this issue), and other lawmakers who remain dedicated to ensuring that America’s drug supply is safe.

Heparin Debacle Tops Chicago Tribune’s Top 10 Local Business Stories of 2008

2009-01-05T10:10:00.004-05:00

On December 31, 2008, the Chicago Tribune reported on the top 10 local business stories of 2008. Heparin contaminated with oversulfated chondroitin sulfate (“OSCS”) that was manufactured and sold by Baxter Healthcare Corporation and Scientific Protein Laboratories, topped this list. (See 12/31/08 Chicago Tribune Article, “Top 10 Local Business Stories of 2008.)

As more and more scientific literature continues to be published linking the contaminate to the hundreds of reported deaths and other adverse events, we expect and hope that this will remain an important public concern this year, particularly for those families who still are awaiting answers whether their loved ones were in fact victims of the tainted heparin.

WORLDFOCUS NEWS STORY ON CONTAMINATED HEPARIN

2008-12-17T16:53:00.006-05:00

Today, Worldfocus editorial consultant Peter Eisner, the former deputy foreign editor of The Washington Post, reported on the deadly contamination of U.S. drugs produced overseas, including heparin.

This news program tells the story of a young couple, Alex and Ann Oryschak, whose infant son, Julien, may have been one of the hundreds of victims who died in late 2007 and early 2008 from tainted heparin that was produced overseas. Producing drugs overseas not only allows powerful drug companies, like Baxter (who sold much of the contaminated heparin), to fly under the FDA radar and avoid government regulation and oversight, but it is cheaper. However, when safety is sacrificed in order to increase corporate profits, there is still a price to be paid. It is Julien Oryschak, Bonnie Hubley, Randy Hubley, Dennis Staples, and the hundreds of others who have lost their lives, who have borne that cost.

We thank reporters like Knut Royce, Peter Eisner, legislators like Representative Bart Stupak, and others, who, like our firm, fight to publicly expose the dirty secrets of the drug industry and effectuate real change.

To view this latest news report by Worldfocus, click here. Also be sure to read Knut Royce's detailed story posted here.

Rep. Barton Questions FDA’s Six Month Delay in Seizure of Tainted Heparin

2008-12-15T17:08:00.002-05:00

On December 10, 2008, U.S. Rep. Joe Barton, (Republican on the House Energy and Commerce Committee), wrote to the Food and Drug Commissioner, Andrew von Eschenbach, asking for information about the six month delay in the FDA’s seizure of contaminated lots of heparin from a manufacturer in Cincinnati, Ohio, Celsus Laboratories Inc.

In November, U.S. Marshalls seized 11 contaminated lots of the blood thinner heparin from Celsus after an April inspection found that the company wasn't properly recalling the product.

The text of the Barton letter states as follows:

The FDA’s management of the heparin issue continues to be of great interest to me and others on the Committee on Energy and Commerce. I commend you for your recent seizure of contaminated heparin from a manufacturer in Cincinnati, Ohio.

However, your November 6, 2008, announcement accompanying the enforcement action indicates that you twice previously informed the manufacturer (during an April 2008 inspection and again in a May 8, 2008, letter) that the company’s actions regarding the contaminated heparin were insufficient to assure an effective recall. I am concerned about this six-month delay between FDA informing the company of its insufficiencies and FDA taking enforcement action, and respectfully request your response to the following:

1. Why did FDA wait until November 2008 to seize the contaminated lots?

2. When was the recommendation to seize this contaminated heparin first made? Who made
it? Was it a written recommendation? Please provide supporting records as appropriate.

3. Please provide all FDA regulations, policies and/or guidances that govern the standards for authorizing this type of seizure.

4. Please list the names, titles, and offices of the FDA officials involved in the recommendation for the seizure of the contaminated heparin.

5. Please list the names, titles, and offices of the FDA officials involved in the decision on whether to approve the recommendation for seizure.

The letter than requested a response in the next four weeks. We will continue to keep you updated.

CDC REPORT IN NEJM FURTHER SUPPORTS LINK BETWEEN OSCS-CONTAMINATED HEPARIN AND DEATHS

2008-12-10T16:51:00.003-05:00

The Centers for Disease Control and Prevention (“CDC”) recently issued a final report in the New England Journal of Medicine (“NEJM”) that confirms a definite link between the man-made contaminant found in heparin, (i.e. over-sulfated chondroitin sulfate, [“OSCS”]) and the patients who experienced reactions. Blossom, David, etc., “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” N. ENGL. J. MED. 359:25, 2674-2684 (December 18, 2008), (available at http://content.nejm.org/cgi/content/full/NEJMoa0806450.)

The CDC was the first to investigate suspected reactions among hospital patients given heparin in November of 2007. Before the contaminant was discovered, the CDC collected data on possible reactions occurring from November 19, 2007 through January 31, 2008 that met its case definition (i.e. development of symptoms within one hour after administration of heparin or the initiation of a hemodialysis session). (In its report, the CDC explained that it used this early case definition as an attempt to reduce misclassification, but recognized that in light of what is being discovered about the contaminate, “some true cases may have been misclassified as noncases.”)

The study did not report or investigate the long term effects of contaminated heparin, the cumulative effect of receiving multiple contaminated doses, delayed onset of symptoms, or the contaminate’s effect on other conditions such as heparin induced thrombocytopenia (“HIT”). Instead, the report simply confirmed that the “reported clinical features” of the limited cases it investigated “further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.”

Washington Post Reports on Needed FDA Overhaul

2008-11-26T18:18:00.004-05:00

The Washington Post reported today that former officials, members of Congress, watchdog groups and various government reports are calling for an overhaul of the FDA, which “desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring.” (11/26/08 Washington Post, “Ailing FDA May Need a Major Overhaul, Officials and Groups Say.”)

The article is worth the read and discusses some of the FDA’s recent failures to monitor imported drugs and consumer products, including contaminated heparin, toothpaste, and pet food from China. As similarly opined in this blog recently, the article also discusses the view that more needs to be done than simply starting to open offices overseas, including sharply boosting inspections abroad, developing strict new regulatory standards, and updating and integrating the FDA's computer systems. To read a copy of this article, click here.

Another Step Closer to Synthetic Heparin

2008-11-25T16:36:00.002-05:00

Today, scientists at the University of North Carolina at Chapel Hill announced that they have discovered how to customize a key human enzyme responsible for producing heparin. (See NewsWise, “Scientists Teach Enzyme to Make Synthetic Heparin in More Varieties.") This important announcement brings researchers closer to developing a more effective synthetic anticoagulant, rather than using raw natural heparin from pigs. As a result, it would shorten the drug chain and make it less susceptible to contamination. This is important because as learned from the heparin debacle, companies such as Baxter and Scientific Protein Laboratories, who are more interested in saving a buck by purchasing product from China rather than protecting the American public, cannot be trusted to ensure the safety of their drug. As stated by Jian Liu, Ph.D., associate professor in the school’s medicinal chemistry and natural products division, “The pig stuff has served us well for 50 years and is very inexpensive, but if we cannot control the supply chain, we cannot ensure the safety of the drug.”

Questions Raised Over FDA's Investigation of Heparin Deaths

2008-11-23T20:57:00.007-05:00

In a letter to the Government Accountability Office (GAO) dated November 19, 2008, Rep. Joe Barton questioned the adequacy of the FDA's ongoing investigation and evaluation of the recent heparin deaths, casting doubt on whether the FDA in fact has used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities. Specifically the letter states, “Based on the available information …there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths.” The letter also questions "whether [the] FDA has confounding or conflicting information about Heparin death cases that has not been made public." A copy of this letter is available by clicking here.

As first described in our July 30, 2008 blog, we also have questions concerning the conclusions reached by the FDA as reported to the Chicago Tribune and Nightline. For example, is the FDA investigating or supporting scientific studies to determine whether the contaminate, OSCS, and its resulting symptoms can cause, contribute to, or leave an individual susceptible to other complications leading to death, such as heart failure? (To date, the FDA admits that it has limited knowledge “since the contaminant was only recently discovered” and that all effects are not yet known. (See FDA Questions and Answers, updated 7/3/08.)) Without such studies, the FDA's conclusions may be premature.

Likewise, if the FDA requires additional information to determine whether additional deaths are related, why isn’t this information being gathered or at least requested from the providers or others who filled out the reports to make an adequate determination? For example, as we stated in our July blog, while we have filed multiple adverse-event reports of clients, to date WE HAVE NEVER BEEN CONTACTED BY THE FDA REGARDING THESE REPORTS, NEVER BEEN ADVISED OF THE STATUS OF THEIR INVESTIGATION, OR TOLD THAT ADDITIONAL INFORMATION IS NEEDED.

We have been contacted, however, by many caring lawmakers, journalists, and scientists who have not forgotten the victims of the heparin disaster. We commend and support their ongoing efforts to obtain answers and accountability from the FDA, Baxter and SPL.

FDA Offices in China: A Baby-Step Toward Public Safety

2008-11-18T09:55:00.005-05:00

In response to the ongoing public outcry for protection from imported drugs and other products, the U.S. Food and Drug Administration is finally taking some action. This week, the FDA is opening three offices in China. (11/17/08, Washington Post, “FDA to open China Offices After Product Scares.”) The first office will be opened in Beijing on Wednesday, followed by one in Guangzhou and another in Shanghai. According to Health and Human Services (HHS) Secretary Mike Leavitt,13 employees will be assigned to work in the FDA offices in China, but he has not said what their role will be.

While this is certainly a good first step, it is only a baby-step. There are thousands of foreign companies who ship drugs into the United States, let alone other consumer products. Thus, additional presence and regulation is needed. Last year the FDA reported that it only had resources to inspect foreign pharmaceutical companies every 13 years. (U.S. Government Accountability Office, Drug Safety: Preliminary Findings Suggest Weakness in FDA’s Program for Inspecting Foreign Drug Manufacturer. Statement of Marcia Crosse, Director of Health Care, before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, November 1, 2007.) It is unclear how much of an impact that three offices with only 13 employees, who must deal with multiple consumer products, (not just pharmaceuticals), will have on the undisputed inability of the FDA to ensure product safety of foreign products.

As often discussed on this blog, this inability to protect the American public underscores why preemption of lawsuits is wrong. Drug and medical device companies argue that Americans injured by defective drugs or medical devices should be barred from bringing suit, because the FDA can adequately protect the American public. The heparin disaster has made it clear that this assumption is inherently flawed.

Indeed, as also reported in this week's news, the House Committee on Oversight and Government Reform released a report showing "that historically the Food and Drug Administration has not sought to preempt state law claims, and that the agency 'viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency's regulatory efforts.'" (11/17/08 Lawyers USA, "Report: FDA Staff Objected to Preemption Policies.") However, during the Bush administration the FDA made a dramatic reversal, adding preemption language to drug regulations. This language has now become "a cornerstone of drug industry preemption arguments."

According to the report, "key career officials" objected to the regulatory changes. The officials "repeatedly warned that the central factual justifications for the agency's new positions were false."

The American Association for Justice ("AAJ") "blasted the FDA over the report, noting that the findings were similar to those in an AAJ report released earlier this month." Geri Voss, Director of Regulatory Affairs at AAJ, said, "In a gift to big negligent corporations, the Bush Administration overrode the advice of career professionals, ignored the agency's history of respect for litigation and put consumer safety on the backburner." For a full copy of “Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability” go to: www.justice.org/getoutofjailfree.

Hubleys and Staples Featured in Time Magazine

2008-11-14T16:38:00.005-05:00

This week our clients, the Hubley Family and Johanna Staples, were featured in Time Magazine regarding the heparin disaster. To read this article, click here. We continue to be proud and honored to represent these brave individuals, who have selflessly agreed to share their private losses and suffering with the public so that the extent and severity of this tragedy may be exposed and hopefully, prevented in the future.

Updated: FDA seizes OSCS Contaminated Heparin

2008-11-07T11:57:00.007-05:00

Yesterday, the FDA seized 11 lots of Heparin products, valued at approximately $112,000, which were found to be contaminated with over-sulfated chondroitin sulfate (OSCS) from Celsus Laboratories in Cincinnati, Ohio. All 11 lots were manufactured with material imported from China, although the FDA reported that the contaminated crude heparin entered the United States prior to the import ban in April 2008. The discovery was found as part of the cooperative efforts by manufactures and the FDA to perform additional testing on all heparin materials to ensure no OCSC contamination. In fact, Celsus informed CNN that these lots had been quarantined by Celsus since March 8, 2008.

The FDA previously reported recalls of heparin products from Celsus Laboratories because of finding that batches of crude heparin Celsus received from their supplier contained OCSC. Celsus was also reprimanded by the FDA earlier this year for insufficient efforts by Celsus to notify its customers about the contaminated heparin products.

Celsus is a private business that has been manufacturing heparin related products, among others, since 1987. It not only provides its products here in the U.S., but also exports to many other countries, such as Australia, Canada, the European Union, and Japan.

Correction to reflect updated information:

USA Today originally reported that the contaminated heparin was imported from Changzhou SPL, the Chinese arm of U.S. based Scientific Protein Labs. USA Today cited FDA Spokeswoman Karen Riley for that information. They have now corrected their story to eliminate SPL as the source of the contaminated heparin after I brought this claim to the attention of the SPL attorney. Celsus had never been listed before as a customer of SPL or CZSPL. It is not clear whether the FDA spokesperson was misunderstood by USA Today, or if the FDA spokesperson was simply wrong as to the source of the contaminated product. Certainly the FDA should clarify this and should announce, publicly, the source of the OSCS contaminated heparin utilized by Celsus.

The FDA says it inspected Celsus Laboratories in April and found that two of its heparin products were contaminated.

The company had sent a letter to its customers telling them its heparin was contaminated, but FDA wanted the company to physically recall the product because of the danger it presented to patients.

FDA sent a follow-up letter to the company again asking for a recall on May 8.

What the federal marshals did Thursday was to seize the contaminated heparin that remained at the company's facilities, Riley says.

Comment: There is nothing in this latest story to establish that importations of contaminated heparin have occurred since April of 2008. But the story does show a conscious disregard by Celsus for the health and safety of the consumer. The FDA should have more power so that they can enforce the recall of these products.

In my opinion the FDA should also focus on inspection of existing health care facilities in this country to insure that all the bad stuff is off the shelf. I am personally more concerned about seizure of existing product in the hands of health care providers than raids to recover product that has already been quarantined.

And I want to know if Celsus used any of the contaminated Heparin in any of the products it shipped since April.

It is going to take much more than this raid to convince Americans that the FDA is doing its job; however the fact that Celsus chose to ignore the FDA request for a recall shows that Celsus has failed to act responsibly and has instead shown callous disregard for the consumer.

UPDATE COMMENT: Celsus should immediately disclose the source of the contaminant. Was Celsus experimenting with the use of OSCS? Did it know the products it sold contained OSCS? Celsus, up to now, has had a very good reputation. Its web site, www.heparin.com states:

Celsus is pursuing the development of a proprietary complex carbohydrate comprising a rare disaccharide sequence that may be prepared by chemical synthesis, genetically modified organism or site selected 6-O-sulfation of dermatan sulfate for medical needs unmet by heparin or its low molecular weight derivatives.

Celsus owes the world an explanation.

Reports of Serious Injuries and Death Linked to Medications Hits a Record High

2008-11-06T10:04:00.005-05:00

On October 23, 2008, The Institute for Safe Medication Practice, (a nonprofit group that educates the healthcare community about safe medication practices), issued a report on the number of serious injuries and death reported to the U.S. Food and Drug Administration in the first quarter of 2008. (See Inst. For Safe Med. Practices: 10/23/08, “Quarter Watch: 2008 Q 1.”)

According to this report, the number of reports of serious injuries and death linked to medications hit a record high. In the first three months of 2008, there were 20,745 new cases of serious injury and 4,824 reports of death. This total was 38% higher than the average for the previous four quarters, and the highest for any quarter. Death cases also accounted for a larger share with 23% for the first quarter of 2008 as compared to a historical average of 16%. This represented a 2.6 fold increase from the previous quarter and the highest number of deaths in a calendar quarter since 2004.

Two drugs accounted for a disproportionate share, including Chantix, a new anti-smoking drug from Pfizer, Inc. (with 1001 cases of serious injury and 50 deaths), and Heparin imported from China, (with 779 cases of serious injury and 102 deaths). (The FDA has actually reported receiving 238 reports of death from contaminated heparin over a longer period, but 102 represent the first quarter.)

Even scarier for the American public is the fact that because reporting is voluntary, these reports represent “only a small fraction of the adverse drug events that occur.” Id. at 1.

As concluded by the Institute, “While prescription drugs bring great benefits to millions of patients and most are used safely, these data show the need for additional progress to better manage the risks to patients….It also underlines the importance of the nation’s system for assuring drug product stability and purity. The scale of injury--hundreds of deaths or serious injuries in a short period—underlines the importance of strengthening oversight of drug manufacture abroad.” Id. at 4.

Boston Globe Editorial on Preemption

2008-10-13T21:03:00.004-04:00

A recent editorial, “No Haven for Dangerous Drugs,” published in the Boston Globe emphasizes the importance of a case often discussed in this blog, Wyeth v. Levine (06-1249), which deals with federal preemption of state drug labeling law and is set to be argued before the U.S. Supreme Court on November 3, 2008.

The Boston Globe Editorial highlights the importance of the issue of preemption in our present times. Given the increasing number of dangerous and defective pharmaceutical drugs and medical devices, such as tainted heparin, and the significant number of Congressional Hearings exposing the shortcomings and clear limitations of the U.S. FDA, barring any claim simply because it received FDA approval is a mistake. Indeed, as noted in the editorial, the U.S. FDA itself is among the many groups who support the argument that federal preemption should not bar a victim’s right to redress.

This editorial is worth reading and is available by clicking here.

The Joint Commission Warns of Heparin Dosing Errors

2008-09-26T11:53:00.002-04:00

On September 24, 2008, the Joint Commission, an independent, not-for-profit organization that accredits and certifies more than 15,000 health care organizations and programs in the United States, issued a heparin safety alert. (See JOINT COMMISSION WEBSITE: 9/24/08 Sentinel Event Alert, “Preventing errors relating to commonly used anticoagulants.”)

According to this report, “anticoagulants have been identified as one of the top five drug types associated with patient safety incidents in the United States.” (Id.) From January 1997 through December 2007, the Joint Commission reported that there 446 medication-related sentinel events (9.3 percent of all events) reported in their event database, with 7.2 percent (32) of these involving anticoagulants; of those, two-thirds (21) involve heparin. (Id. See also the illustrative chart on the Joint Commission Website.) Further, according to the United States Pharmacopeia MEDMARX database, there were a total of 59,316 medication errors related to anticoagulants reported to their database from 2001 to 2006 (these data do not include errors involving heparin lock flush). (Id.) According to the report, “nearly 60 percent of these errors reached the patient and nearly 3 percent resulted in harm or death.” (Id.) Further, “performance error (e.g., administration) is the most common cause of adverse events relating to anticoagulant medications.” (Id.)

The Joint Commission explained in its report that “heparin and warfarin in particular have narrow therapeutic ranges and a high potential for complications, so there is a greater risk of patient harm.” (Id.) It also listed the following factors which also contribute to medication errors involving anticoagulants:

• Lack of standardization for the naming, labeling and packaging of anticoagulants creates confusion. For example, heparin flush syringes have been confused with LMW heparin syringes. In addition, other, lesser-known anticoagulant drug names exist (e.g., enoxaparin, dalteparin, tinzaparin) and are used less commonly, which can result in duplicate medication orders and erroneous dosing.
• Keeping current with different dosing regimens for various patient populations, newer assay methods, the expanding lists of drug interactions, and the potential reversal strategies can be a challenge for providers—especially those who infrequently prescribe or administer anticoagulants.
• The specific and individualized instructions and monitoring information (for example, dose adjustments, lab values, changing patient condition) that accompany the prescribing and administration of anticoagulants may fail to get documented or communicated during transfers and hand-offs.
• Neonates and other pediatric patients are problematic to treat, specifically because the medications are formulated and packaged primarily for adults.

(Id.) The Joint Commission offers suggestions on how to reduce these dangers.

What is missing from the report is the danger of contamination and the lack of updated and appropriate testing for imported drugs, which unfortunately, may have claimed as many lives in a just few months, as dosage errors have claimed in the past ten years.