Heparin Deaths

Merck and Schering Plough settle investigation

2009-07-15T14:37:00.000-07:00

Another case of large pharmaceutical in trouble with the FDA for improper disclosure. This time it is Merck and the drugs are Zetia and Vytorin. The legal settlement is for peanuts and is clearly being done to expedite a Wallstreet acquisition. But why is it that our drug companies continue to mislead?

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com

Date: 7/15/2009 5:23 PM

MARLEY SEAMAN,AP Health Writer

NEW YORK (AP) — Drugmakers Merck & Co. and Schering-Plough Corp. said Wednesday they will pay $5.4 million to settle a multistate investigation that the companies delayed the release of test results casting doubt on the effectiveness of two blockbuster cholesterol drugs.

The companies settled with attorneys general from 35 states and the District of Columbia. The investigation centered on allegations the companies kept quiet the results from an unfavorable study, violating consumer protection laws. Merck and Schering-Plough will pay back the costs of the investigation, but don't have to make other payments or admit wrongdoing or liability.

In January 2008, the companies released study data showing Vytorin and Zetia, sold by the Merck/Schering-Plough Pharmaceuticals joint venture, were not more effective than an older, much-cheaper drug at reducing plaque buildup in the blood vessels of the neck. The testing was finished in 2006 and the companies faced criticism for not releasing the results sooner.

The study compared Zetia and Vytorin to Zocor, a drug that is one of Vytorin's ingredients. Zocor is available as a low-cost generic drug. Later studies raised additional concerns about safety and effectiveness.

Kentucky Attorney General Jack Conway said the companies agreed to get advance Food and Drug Administration approval for all TV advertisements aimed at consumers and comply with FDA suggestions to modify that advertising. Additionally, the companies will register clinical trials and report results and agreed to comply with rules barring the deceptive use of those trials, avoid ghost writing of articles by physicians, and reduce conflicts of interest on boards monitoring clinical trials.

The state of Kentucky — where the agreement was filed — will receive $100,000 in the settlement.

Merck, of Whitehouse Station, N.J., and Schering-Plough, based in Kenilworth, N.J., said they will continue to comply with laws requiring the truthful and non-misleading marketing of their drugs. A study published in the New England Journal of Medicine showed Merck and Schering-Plough spent $200 million to market Vytorin and Zetia to consumers in 2007.

"We think this agreement is consistent with what we've said and what we believe, which is that the company conducted the ENHANCE trial in good faith and that our promotion of Zetia and Vytorin were in compliance with the law," said Merck spokesman Ron Rogers.

Rogers said settling for legal costs was in the best interest of all concerned and lets Merck and Schering-Plough remain focused on creating new medicines and vaccines.

The settlement does not resolve all the lawsuits and investigations involving the drugs, however. In a May regulatory filing, Merck disclosed that subcommittees from the U.S. Senate and House of Representatives have asked the company and Schering-Plough to interview employees and examine documents related to Zetia and Vytorin. Merck also disclosed that the Justice Department is investigating the companies' conduct in selling the drugs, and the possibility that they may have submitted false claims to federal health care programs as they promoted Vytorin.

Merck said it was then aware of 145 civil class action lawsuits related to the drugs.

The 35 states involved in Wednesday's settlement are Arizona, Arkansas, California, Colorado, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.

Merck is in the process of buying Schering-Plough for $41.1 billion. Merck shares rose 55 cents, or 2 percent, to close at $27.71. Schering-Plough stock added 45 cents, or 1.8 percent, to $25.37.

Copyright 2009 The Associated Press.

FDA clears Eli Lilly's blood thinner Effient

2009-07-13T07:15:00.000-07:00

The FDA is back in the news today, with the story another blood thinner, but not Heparin this time, but Effient. Let us hope that the FDA's oversight of such new drug will not just be limited to its approval, but also how it is made and where it is made. Approving a drug is one thing. Making sure it is that drug that is administered to the sick, is another.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com

Date: 7/10/2009 6:08 PM

MATTHEW PERRONE,AP Business Writer

WASHINGTON (AP) — The Food and Drug Administration on Friday approved a highly anticipated blood thinner from Eli Lilly, though the drug must carry the agency's sternest warning because of its bleeding risks.

The approval makes Lilly's Effient the first real competition to the blood thinner Plavix, the world's second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb.

The FDA delayed its decision on Effient multiple times during an 18-month review, as agency staffers weighed the drug's benefits versus its risks.

A study of over 13,000 patients conducted by Lilly found that Effient prevents more heart attacks than Plavix, but also causes more internal bleeding.

The FDA said Effient will carry a boxed warning to alert physicians to the risks of "significant, sometimes fatal, bleeding." The boxed warning is reserved for issues that can cause serious injury or death.

The drug should not be taken by patients with a history of bleeding, stroke or who are undergoing surgery, the FDA said.

"Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug," said Dr. John Jenkins, FDA's director of new drugs.

The drug offers an alternative treatment for preventing dangerous blood clots that can lead to heart attack or stroke, Jenkins said.

The boxed safety warning could curb sales, but not to a large extent, according to Miller Tabak & Co. analyst Les Funtleyder.

"The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare," said Funtleyder. "But it still has the ability to somewhat limit sales."

Company studies showed 7 percent of patients taking Effient experienced nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death were similar for both drugs.

Indianapolis-based Lilly developed Effient, known chemically as prasugrel, with Japanese drugmaker Daiichi Sankyo Co. The two companies will share revenue.

"After more than a decade of research and testing, we are proud to provide this new treatment option to patients with acute coronary syndrome," Daiichi President Takashi Shoda said in a statement.

Wall Street analysts say Effient sales could reach an estimated $1 billion annually, compared with the $4.9 billion racked up by Plavix last year.

Like Plavix, Effient prevents blood platelets from sticking together and forming potentially dangerous clots. But where Plavix is approved for use in a wide range of patients, Effient is only approved for those undergoing angioplasty, a procedure in which an inflatable balloon is used to clear arteries clogged with plaque, which are often propped open with a stent.

Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire by 2013.

But even if the drug reaches the $1 billion mark, it will have trouble replacing the revenue of Lilly's best-selling product, the anti-psychotic Zyprexa, which garnered $4.7 billion in sales last year.

Copyright 2009 The Associated Press.

FDA Funding Increase in Wake of New Head for Agency

2009-05-08T07:32:00.000-07:00

The below story from the AP about Obama's pick for the FDA is good news for all Heparin advocates because it signals a shift from a corporate friendly FDA to one based on science and consumer safety. Nominated for head of the FDA, Dr. Margaret Hamburg has received little opposition in committee and her confirmation is expected soon. More significant is the Obama administration intent to substantially increase the FDA's budget and to stop political appointees from silencing the scientists at the FDA.

More money and independence is absolutely needed at the agency. Swine flu is only a small part of the agenda. Food and drug contamination are bigger threats. The FDA can simply not allow a thirty-year backlog on inspections of overseas drug plants. The FDA cannot do its job with a regulatory structure that allows the new plants to produce until the FDA finds something out of compliance. The law must require inspection and compliance, before drugs are shipped to the U.S. The conditions found by the FDA at Chanzghou SPL where Heparin was contaminated, cannot be allowed to exist in facilities making pharmaceuticals.

Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2009

WASHINGTON (AP) — President Barack Obama's pick to oversee food and drug safety pledged on Thursday to revamp protection of the nation's food supply to help prevent future disease outbreaks.

Dr. Margaret Hamburg, a bioterrorism expert who once served as New York City health commissioner, breezed through her confirmation hearing before the Senate Health, Education, Labor and Pensions committee, with no senators expressing opposition.

Hamburg, 53, said she wants to restore public confidence in the Food and Drug Administration by putting science first and running an open and accountable operation.

The full Senate is expected to vote on her nomination before Memorial Day. If confirmed, Hamburg's most immediate task will be to oversee development of a vaccine for the new swine flu. But she said food safety will be her major ongoing project.

"The agency is facing a range of new and daunting challenges," Hamburg told senators. "These include the globalization of food and drug production, the emergence of new and complex medical technologies, and the risk of adulteration or deliberate terror attacks on our food and drug supplies."

The FDA oversees products ranging from peanut butter to cancer drugs to medical imaging machines — a portfolio that represents about a quarter of consumer products. A few years ago, it was shaken by the withdrawal from the market of Vioxx, a painkiller that turned out to have serious heart risks. More recently, outbreaks of foodborne illness have exposed haphazard oversight of the nation's far-flung food supply chain. Within the agency, scientists in the medical devices center are in revolt over what they say is management interference. And a federal judge recently ruled that the FDA improperly politicized a decision on emergency birth control during the Bush administration.

On top of all that, the FDA must play a critical role in developing a vaccine for the new swine flu virus and ensuring that enough vaccine can be made to protect the public.

Hamburg, as an assistant health secretary under President Bill Clinton, helped lay the groundwork for the government's bioterrorism and flu pandemic preparations.

The swine flu vaccine will be her first task. "I look forward to being actively involved in discussion on such critical issues as how much vaccine to make, whether to alter seasonal vaccine manufacturing, and, ultimately, whether to recommend vaccination for the American people," Hamburg said.

Vaccinating the entire population for swine flu would be a huge undertaking, and might require more than one shot. It would also have to be coordinated with preparations for the regular flu season. But such a large scale effort may not be needed if the virus turns out to be mild.

Turning to food safety, Hamburg said it will require sustained effort, more money, and stronger laws to improve the situation. She wants to shift from chasing outbreaks after they have broken out to preventing them first. That would require all food companies to follow written safety plans, overseen by federal and state inspectors. Traceability and import safety — weak links in the system — would have to be strengthened.

Obama's budget, released Thursday, calls for a $260-million increase for the FDA's food safety program. Past budget cuts have hit the food inspection program hard, and part of the new funding would go to rebuild the ranks of inspectors.

Hamburg said she supports FDA regulation of tobacco and allowing Americans to import low-cost brand name prescription drugs from abroad, positions consistent with Obama's.

Hamburg's professional career has centered on public health. She is the daughter of two doctors, and her family background includes African-American and Jewish heritage. Her mother was the first black woman to earn a medical degree from Yale University. She credits her father's side of the family for imbuing in her a passion for social concerns.

___

Associated Press writer Erica Werner contributed to this report.

Rep. Barton Demands Answers about Heparin Contamination

2009-05-07T16:56:00.000-07:00

Finally someone in Washington has remembered that there are still consequences to what they called a “catastrophe” last year.

According to the Dow Jones Newswire, Rep. Joe Barton, R.-Texas, "is pressuring the U.S. Food and Drug Administration for more information about contaminated heparin from China amid concerns that the agency doesn't know what caused U.S. patients to get sick or die while taking the blood thinner last year."

Barton is a member of the House Energy and Commerce Committee which held hearings last year. He has written a letter to the FDA demanding the agency turnover databases on the Heparin contamination. According to Dow Jones:

Barton is trying to determine whether anyone in China has been held responsible for contaminating heparin that ultimately sickened and killed U.S. citizens.

"We don't seem to be any further along a year later from understanding" this issue, said an Republican staffer for the committee, who asked not to be named. "What are they doing about it? Is this an acceptable practice in China?"

It is time that the FDA went public with all it knows about the Heparin Catastrophe. Freedom of Information Requests have been pending before the agency for more than a year now. What does the FDA know? Why are they not telling the American public about the full breadth of this poisoning?

Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2009

FDA Warns Qingdao Heparin Company, conclusion

2009-05-03T22:03:00.000-07:00

The FDA warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. concluded as follows:

Please also address in your response to this letter the following issues:

During the inspection, the investigators were informed that your firm does not distribute heparin sodium directly to the U.S. and that the product manufactured was shipped to Shanghai. During an inspection conducted at a U.S. facility, we found purchase orders and information indicating that since 2005, heparin sodium manufactured at your facility was being shipped into the U.S. Please clarify whether you shipped drugs directly to the U.S. and provide a list of all lots of heparin sodium (intended for experimental or commercial use) shipped to the U.S. since your firm started to manufacture heparin sodium. Please also identify whether you shipped drugs that you understood were ordered by or ultimately destined for the U.S., even if you did not ship them directly to the U.S. yourself. Also include a list of any other customers to whom you have supplied heparin sodium or other substances intended for the U.S. market. Include the amounts shipped and dates of all  shipments.

Please also explain the relationship between your firm and (b)(4). Please provide information regarding any lots of heparin sodium that were shipped by (b)(4) on your firm’s behalf, including lot numbers, dates of shipments and amounts.
In light of the above and the fact that your predecessor (Qingdao Kangyuan) was never inspected by FDA and apparently no longer manufactures heparin sodium, we expect you to address the reliability of any information generated regarding the manufacture, processing, testing, packaging, and labeling of heparin sodium shipped to the U.S. and used to support your DMF 22222.

One way you can do this is by employing a third party auditor to conduct a validity assessment of the information you have provided or intend to provide to support your DMF regarding the production of heparin sodium. Conducting such an audit could expedite the process of re-qualifying your facility.

The listed deficiencies are not to be considered an all inclusive list of deficiencies at your facility. FDA inspections are audits, which are not intended to address all deviations from CGMP or all violations which may exist at a firm. If you wish to ship your products to the U.S., you are responsible for ensuring compliance with all U.S. standards for CGMP and all other applicable U.S. laws and regulations.

Until FDA has confirmed corrections of the deficiencies and compliance with CGMP, this office may recommend withholding approval of any new applications listing your firm as the drug manufacturer. In addition, shipments of articles manufactured at Qingdao Jiulong Biopharmaceutical Co., Ltd located at Jiulong Indusrial Garden Jiaozhou, Qingdao, Shangdon Providence 266319, People’s Republic of China facility and shipped into the U.S. are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act [21 U.S.C. 381(a)(3)], in that, the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of Section 501(a)(2)(B) of the FD&C Act [21 U.S.C. 351(a)(2)(B)].

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice. Please respond to this letter within 30 days of receipt. Please identify your response with FEI 3006745882. If you have any questions concerning this letter, you may contact Carmelo Rosa, Compliance Officer at the address and telephone numbers shown below.

U.S. Food & Drug Administration  Center for Drug Evaluation and Research  Division of Manufacturing and Product Quality  International Compliance Team  White Oak Building 5110903 New Hampshire Avenue  Silver Spring, Maryland 20993  Tel: (301) 796-3667  Fax: (301) 301-847-8741

Sincerely,
/s/
Richard L. Friedman  Director  Division of Manufacturing and  Product Quality  Office of Compliance  Center for Drug Evaluation and Research  Office of Compliance

Maybe you should write the FDA and tell them what you think about importing dangerous drugs from China?

Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2009

FDA Warns Qingdao Heparin Company, continued

2009-05-01T10:12:00.000-07:00

In the third part of the FDA warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. the focus was on the presence of the OSCS contamination:

3. Your firm failed to investigate specific discrepancies related to the lots of impure drugs supplied to your customers. We learned that heparin sodium lots manufactured at your facility were determined to be contaminated with OSCS. At the time of the inspection, no investigation had been conducted into this repeated and unacceptable contamination.

From our investigation, it appears that your customer requested that your firm investigate the OSCS contamination. Although the contamination of these lots was discussed during the inspection, you apparently had not initiated an investigation to determine the root cause of the contamination, identified whether other lots were implicated, or taken appropriate corrective actions to prevent recurrence of this contamination.

Your firm’s failure to investigate these significant customer complaints is a serious deviation from CGMP. It is your firm’s responsibility to ensure that drugs manufactured at your facility are produced in compliance with CGMP. This includes establishing adequate systems to detect such quality issues before an adulterated product is distributed, and promptly implementing corrective measures to prevent recurrence.

No information was provided to assure that any of your firm’s internal practices or upstream sources (e.g., suppliers) that may have been involved in the contamination of the 19 lots produced has been identified and removed from your supply chain. Please include in your written response to this letter a copy of all investigations regarding OSCS that may have been conducted after the inspection, the root cause of the contamination, and the corrective actions implemented to prevent recurrence. Also include the list of the crude and other upstream suppliers for all of the contaminated lots.

The investigators were informed during the inspection that all lots of heparin sodium produced at your facility would be tested using the CE and NMR methods beginning in September 2008. Please state in your response whether your firm has begun to test the heparin sodium using these methods or if these analyses are being outsourced, and when this testing commenced. If your firm has decided to outsource these tests, include in your response the identity of the contract laboratory, their physical address and the qualification report.

Only one inference is possible from these detailed complaints by the FDA: The Chinese don't seem to care about the safety of a drug intended for IV use with the sickest of Americans. Such complete failure could not have slipped by even the most cursory of investigation.

Attorney Gordon Johnson
http://heparin-law.com
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800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

FDA Heparin Warning Letter, continued

2009-04-30T17:48:00.000-07:00

A different wrongdoer, but so many similar complaints to what the FDA found wrong with Baxter/SPL's production of Heparin. Here is the second part of the FDA warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. Like Chanzghou SPL, insufficient quality review was pervasive.

2. Failure to conduct and document regular product quality reviews for the drugs produced that would include at a minimum, a review of your critical in-process controls and test results; review of all batches that failed to meet the established specifications; and investigation of process deviations and complaints to ensure your product remains within specifications and that corrective actions have been implemented.

In a letter sent to your attention on September 29, 2008, we informed you that your written response to the FDA-483 of August 13, 2008 was found deficient and lacked specific information related to the responsibilities of your quality control unit. In your letter of November 07, 2008, you acknowledge our concerns regarding the failure to perform product quality reviews by committing to perform Annual Product Reviews. You indicate that most of the product review activities were documented as part of your annual internal auditing reports. However, during the inspection, the investigators noted that your annual internal reviews involved only completing a check box document. This product quality review is inadequate in that it lacks adequate content or information, such as explanation of all deviations from established procedures and outcome of  investigations of critical deviations.
Although in your response of November 7, 2008 you include a new SOP specifying that “Annually, QA shall perform annual quality review on all products manufactured, distributed and marketed by the Company,” the corrective action implemented is inadequate. We are concerned that you have only committed to conduct an “annual product review for product lots produced during 2008.” As you are aware, 19 lots of heparin sodium manufactured at your facility during 2007 and shipped to the U.S. were found contaminated with OSCS.

Please include in your response a copy of complete product quality review reports covering the manufacturing of heparin sodium for all lots that remain within expiration. Include the following:

A review of all critical in-process controls and critical test results.  • A review of all batches that failed to meet established specifications.  • A review of all critical deviations or non-conformances and related investigations.  • A review of any changes carried out to the process or analytical methods.  • A review of the stability monitoring program.  • A review of all quality-related returns, complaints (formal or informal from all customers) and complaints.  • A review of adequacy of corrective actions implemented (also include the conclusions).

OSCS again. Is there a common thread here?

Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2009

FDA Warning Letter for Bad Chinese Heparin

2009-04-22T07:04:00.000-07:00

The problem of bad Chinese Heparin, and even OSCS, has continued into 2009. Yesterday we outlined the problems the FDA cited with Qingdao Jiulong Biopharmaceuticals Co. Ltd. manufacture. Here is the first part of the FDA warning letter to Qingdao.

WARNING LETTER  WL NO. 320-09-02
April 14, 2009

VIA FEDERAL EXPRESS
 Ms. Wang Weiru  President  Qingdao Jiulong Biopharmaceuticals Co. Ltd.  Jiulong Industrial Garden,  Jiaoshou City  Qingdao, People’s Republic of China (PRC) 266319

Dear Ms. Weiru:

This is regarding an inspection of your pharmaceutical manufacturing facility, Qingdao Jiulong Biopharmaceutical Co., Ltd. (QJBC) located at Jiulong Industrial Garden Jiaoz, Qingdao, Shangdon Providence 266319, People’s Republic of China, conducted by Investigator Carl Lee and Compliance Officer Zi-Qiang Gu, Ph.D., during the period of July 28 to August 1, 2008. The inspection and other information revealed significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs.

Deviations were listed on an Inspectional Observations Form (FDA-483) issued to you at the close of the inspection. These and other CGMP deviations cause your heparin sodium to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 351(a)(2)(B)]. Section 501(a)(2)(B) of the Act requires that all drugs, as defined in the Act, be manufactured, processed, packed, and held according to CGMP.

We have reviewed your August 13, 2008 written response to the FDA-483 observations and subsequent response of November 7, 2008 to our Request for Additional Information Letter of September 29, 2008. We note that you assert that some corrections have been completed or will soon be implemented. However, your response does not adequately address some of the deficiencies. Our review of the information revealed the following CGMP violations:

1. Your firm’s quality unit fails to have the appropriate system and procedures to provide confidence that the drugs manufactured at your facility meet the intended specifications for identity, strength, quality and purity.
In April 2008, FDA learned that 19 lots of heparin sodium were contaminated with Over-Sulfated Chondroitin Sulfate (OSCS), and these lots were later determined to have been manufactured at your facility. Although this heparin sodium did not ultimately reach U.S. patients, your firm has not demonstrated that it has conducted an investigation of these contaminated lots, identified the source of this contamination, and taken appropriate corrective actions to ensure the quality of heparin sodium produced at this site. There is no assurance that your quality unit has systems in place to prevent manufacture and distribution of heparin sodium that has been contaminated with OSCS or other hazardous contaminants. These lots were supplied to Shanghai No. 1 Biochemical Pharmaceutical Co., Ltd. (Shanghai) over an extended period, spanning 2007 and 2008, for distribution under their name.

We are concerned that your firm lacked adequate systems to ensure the safety of raw materials used in your manufacturing, particularly to prevent the substitution of an unsafe substance (OSCS) in place of heparin sodium. It is essential that strict controls over your suppliers be established to prevent any such supply chain breach.
Your firm also failed to ensure that manufacturing and testing procedures apparently transferred to your facility provided for acceptable drug identity, strength, quality, and purity. It is critical for a firm to assess the impact of a change in manufacturing facility, including determining how production and control practices and conditions at the new facility may affect the identity, strength, quality, and purity of a drug.

During the August 2008 inspection, our investigators learned that your current manufacturing process for Heparin Sodium USP was apparently transferred in 2005 from Qingdao Kangyuan, which you assert is a related business entity, to your site and that Qingdao Kangyuan no longer manufactures heparin sodium. However, no information regarding the procedures, protocols and reports related to this technology transfer were available for review. Only estimated dates of when Qingdao Kangyuan ceased manufacturing heparin sodium and when your firm initiated production were provided.

In our next blog, we will continue with the warnings given to Qingdao with respect to its failure to conduct regular product quality reviews.

Attorney Gordon Johnson
http://heparin-law.com
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©Attorney Gordon S. Johnson, Jr. 2009

FDA Cites Chinese Heparin Makers

2009-04-21T23:03:00.000-07:00

The FDA on April 14 issued a warning letter to two Chinese companies for shipping Heparin after the FDA closed Chinese imports of the drug- Qingdao Jiulong Biopharmaceuticals Co. Ltd. and Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd. The Warning letter to Qingdao Jiulong Biopharmaceuticals Co. Ltd. (Qingdao) highlights similar problems in production as were found in the Inspection of Chanzghou SPL, discussed recently on this blog. Those problems included:

1. Qingdao's quality unit failed to have the appropriate system and procedures to provide confidence that the drugs manufactured at the facility met the intended specifications for identity, strength, quality and purity.
2. Qingdao failed to conduct and document regular product quality reviews for the drugs produced that would include at a minimum, a review of critical in-process controls and test results; review of all batches that failed to meet the established specifications; and investigation of process deviations and complaints to ensure the product remains within specifications and that corrective actions had been implemented.
3. Qingdao failed to investigate specific discrepancies related to the lots of impure drugs supplied to its customers. The FDA learned that heparin sodium lots manufactured at Qingdao's facility were determined to be contaminated with OSCS. At the time of the inspection, no investigation had been conducted into this repeated and unacceptable contamination.

We will look at each specific issue on these warning letters in our subsequent blogs. However, that these problems are now occurring at other Chinese suppliers shows how perilous it was for Baxter to import Heparin from a place so seemingly incapable of controlling quality, purity and standards.

Attorney Gordon Johnson
http://heparin-law.com
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g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Baxter - Heparin: A Funny Way to Apply Expertise

2009-04-07T09:51:00.000-07:00

Yesterday we ended our series of the four serious problems that the FDA found with the Changzhou SPL plant in China with the statement that Baxter’s failure to control what SPL was doing in China was outrageous. Today, I discovered this quote on Baxter’s website, http://www.baxter.com/about_baxter/news_room/news_releases/2009/03_05_09_world_kidney_day.html

Baxter International Inc. (NYSE:BAX) develops, manufactures and markets products that save and sustain the lives of people living with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

If Baxter’s mission is to apply a unique combination of expertise, how could they have delegated the critical steps in making an intravenous pharmaceutical to a company who didn’t have anyone on site who understood what he was doing? Poor quality control of the manufacture of Heparin API at Changzhou SPL, meant poor quality control of Baxter Heparin. If the stuff which Heparin is made from isn't pure, the Heparin can't be.

Baxter claims they inspected Changzhou SPL but how could such inspection done within six months of the FDA inspection, not have uncovered such blatant systemic problems? That failed inspection may have been responsible for thousands of deaths. Isn't it time for justice for those casualties?

Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2009

Heparin - FDA's SPL Inspection - No One in Charge

2009-04-06T09:09:00.000-07:00

Today we discuss what has to be the most staggering aspect of the manufacturing situation at the Changzhou SPL plant in China, Baxter's source of the API which made up the contaminated Heparin: No one with specialized knowledge of Heparin, was working for SPL in China.

These quotes are taken from the April 29, 2008 hearings before the House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Regina Brown of the FDA was questioned in those hearings by U.S. Representative, Jan Schakowsky:

Question by Schakowsky: There was no person with special knowledge of Heparin at the firm to guide decisions made by the quality unit. So Ms. Brown, I would assume that if a plant was making Heparin API, it would want to have a person with “special knowledge” of that product, in case deviations from any manufacturing process were observed, wouldn’t you agree?

Answer by Brown: They had a quality unit there, which consisted of four people, they were trying to track what was going on with the firm. The person with the special knowledge I mentioned, because when I arrived, management was aware that there were Baxter recalls, and that there were adverse drug events and deaths in the United States. It was middle of February, the general manager of the firm, Mr. Wong, was the one who described the process to me and how he thought that impure materials were removed from the crude heparin to make it into the heparin API and he said he wasn’t a heparin expert. And so, he was really the person who gave me my fullest extent of knowledge during the inspection.

Q: So, neither he nor the others had any special knowledge, he had the most knowledge?

A: I believe so, yes.

Unbelievable. SPL is manufacturing a drug that is going to be put in to the veins of our sickest people and they don't have anyone on site with specialized knowledge as to how to make Heparin? How could Baxter have allowed this? Any superficial investigation would have determined that Changzhou SPL didn't know what it was doing. Such a breakdown in the process of making an intravenous pharmaceutical is outrageous and is an institutional catastrophe.

Heparin - More on SPL Inspection

2009-04-02T07:48:00.000-07:00

Today we discuss additional problems with the equipment used at the Changzhou SPL plant in China when that plant was inspected by Regina Brown of the FDA.

Again, these quotes are from the April 29, 2008, House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Brown was questioned in those hearings by U.S. Representative, Jan Schakowsky:

Answer by Brown: Another piece of equipment that was the centrifuges that they used to get rid of the waste protein. They used two of them. They had one that would be in use and they would clean the sludge out of the other one, while, to find out how long they should run the one that was going, that would last 30 minutes, without getting to full. And that was a very unusual manufacturing step. It wasn’t described in the procedures for how to use the centrifuges. So you had to actually be at the plant to try and figure out what they were doing.

Normally you see one centrifuge and you run your material thru it and separate the solid from the liquid.

A third piece of equipment that was outstanding to me was their lyophilizer, it was, they didn’t have the software that would provide for the person running it, for the perimeters, that he put in it.

Q by Rep. Schakowsky: What is that?

A: The lyophilizer is a big freeze dryer.

Put in trays of liquids and they turn into solids after days, sometime. You freeze the liquid and you warm it up slowly, they are under vacuum. So it turns into a solid material. So and for this lyophilize there were no records of the actual perimeters that were punched into the screen at the front of it. But there was no screen at the front of it. No way to tell what temperature they actually used to dry the material.

Q: So this is clearly substandard or not up to par, or what should be?

A: Yeah, the settings weren’t there.

Q: Why couldn’t Baxter’s audit have found these things, do you think?

A: I don’t know. I walk thru facilities as part of my inspection. I don’t know if they do that.

What is so disturbing about this revelation is that this was not a matter of simple neglect, made worse by a long standing practice of poor oversight. This was a flawed process from its inception. This process does not even contemplate a scientific process to assure that the API is pure.

Baxter's Heparin Contamination - More on SPL Inspection

2009-03-29T17:02:00.000-07:00

In our previous blogs, we discussed the first of the four essential problems with the manufacture of Heparin API at the Changzhou SPL plant in China. Today, we discuss the second, which is non-sterile equipment found during the FDA’s inspection of Changzhou SPL plant in China. Changzhou SPL was the supplier of the contaminated Heparin to Baxter.

Again, these quotes are from the April 29, 2008, House Subcommittee on Oversight and Investigations hearings, see: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

Regina T. Brown, FDA Consumer Safety Officer was the FDA Officer at the Changzhou SPL plant. U.S. Representative, Jan Schakowsky’s, questioning of Brown included the following with respect to the substandard equipment:

Question by Rep. Schakowsky: You found that the equipment SPL used to manufacture heparin may not have been suitable for its intended use, isn’t that correct?

Answer by Brown: Yes.

Q: And how was it unsuitable and why is this important?

A. There were three different pieces of equipment that I found unsuitable for use.

The first was these big polyethylene tanks that they dissolved heparin up in, just prior to the last manufacturing step, which was a liofolization, a freeze drying step. And these PE tanks were scratched on the bottom, very scratched, as if somebody had been chopping stuff out of them with plastic. I ran my fingernail along it and it was like playing an accordion. And there also was stuff adhering to the bottom of these tanks.

Q: This was inside?

A: On the inside of the tanks where crude heparin would be right before it became heparin API. So I scratched stuff off the inside of the tank. And this was tank that was marked clean.

A second PE tank I turned over and liquid fell out of the handle, the molded, PE comes from a mold polyethylene, and stuff, a liquid fell out of the handles into the bottom of the tank. And it was marked cleaned. So it wasn’t a clean tank.

Q: Stuff. Do we know what stuff was in there?

A: The stuff I scratched off? No I don’t know what it was. It was a little gray colored, it wasn’t white. That is all I know.

If Brown was describing the conditions of a commercial kitchen, this would be a serious area of concern. But that such non-sterile conditions could occur in the manufacture of an intravenous medicine to be given to ill people, is simply outrageous. Baxter claims to have inspected this plant in the months before word of this calamity reached the U.S. market. It is hard to imagine how an honest inspection could have been done by Baxter, in light of what the FDA inspection showed.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
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http://thelegaltimes.net
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800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Heparin Contamination - Flawed Processes to Determine Purity of the Drug

2009-03-28T05:53:00.000-07:00

In our previous blog, we discussed the four essential problems with the manufacture of Heparin API at the SPL found during the FDA’s inspection of Changzhou SPL plant in China, which was the supplier of the contaminated Heparin to Baxter.

On April 29, 2008, the House Subcommittee on Oversight and Investigations initiated hearings: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

There were four majors areas of problems with production at Changzhou SPL highlighted in the testimony of Regina T. Brown, Consumer Safety Officer who did the inspection for the FDA. The first area was that inadequate procedures were being followed to determine what was in the Heparin API. Ms. Brown was questioned by U.S. Representative, Jan Schakowsky/: from Illinois, as follows:

Q of Rep. Schakowsky: Isn’t it true that SPL’s processing steps provided no assurance that they were capable of removing impurities:

Answer of Brown: YES.

Q: Now can you tell us why understanding the origin, quality and purity of these materials are essential for meeting Good Manufacturing Practices, particularly when you are making a biologic, such as Heparin?

A: In particular for Heparin, the Certificate of Analysis that came with the crude material into Changzhou SPL was the only source identifying it as crude heparin from a porcine source, from pigs.

Q: And why is that important that that was the only document?

A: Changzhou SPL had just begun PCR testing, which verifies the pig origin of the crude heparin in June or July of 07. So it was a relatively new test that they were doing. Prior to that, they hadn’t done it at all in China.

Q: Didn’t you find that the test methods performed by Changzhou SPL not been verified to assure suitability under actual conditions of use, is that what you are saying that it was unverified?

A: Yes, unverified. The tests that they ran were USP Compendial methods and we ask firms to verify that methods are suitable for use with their particular product.

Q: So what does it mean when the FDA says Changzhou SPL tests methods had not been verified to assure suitability under actual conditions of use, and why is this important?

A: One of the tests they ran was a protein test, that was a turbidity test, they put required solution in a in a big test tube, then added there substance to it and if turbidity showed up, the crude heparin did not have protein in it and if it did show up, it did have heparin in it and the crude heparin didn’t have heparin in it.. if it did show up, their was protein there. I think it was the opposite. If it got turbid there was protein in it.

A: “It is kind of a crude test, the first steps of the purification process, for heparin, involved getting rid of protein, so when they tried to do a process validation, and they use this turbidity test, in the process validation too, they never showed that it was repeatable and it may not have been suitable for use as an in product test or a even as a finished product test.”

The problem with this test is that it is not just a crude test. It is only an inclusion test. It tells SPL only that there is Heparin in the raw material, not that other impurities are not in the product.

Our next blog will discuss Regina Brown’s testimony with respect to non-sterile equipment that was used to make this drug.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
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http://vestibulardisorder.com
http://thelegaltimes.net
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g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Heparin Contamination - More than Just OSCS

2009-03-25T12:25:00.000-07:00

One of the surprising things to me when I consider the scope and controversy about the Baxter Heparin debacle, is that all of the focus is on OSCS (the identified anaphylactoid agent) not the total lack of sterility in a IV drug. Defense tactics in major cases are all about misdirection and even though it seems somewhat self-defeating to do so, Baxter has succeeded in limiting the inquiry into the Heparin deaths to the issue of whether there was OSCS in a given dose.

That is wrong. This is a drug intended for intravenous administration to extremely sick people. To assume that the only problem with Baxter’s manufacture of an IV drug outside the U.S. is this one identified contaminant, is naive. What we know from the Congressional testimony of those who inspected the Chanzghou SPL plant is that no proper procedures were being followed, no one on site had any meaningful expertise in the manufacture of heparin and that they were using unsanitary equipment that was being used to product that had to be sterile and pure.

On April 29, 2008, the House Subcommittee on Oversight and Investigations held hearings entitled, The Heparin Disaster: Chinese Counterfeits and American Failures
For more on those hearings, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml

The link provides written transcripts of the prepared remarks of the witnesses at such hearing, which included four panels, detailed below. However, the transcript of such hearings has never been added to that page, and I have been unable to find a copy of it online. Further, I requested such transcript the day of the hearing but have never received it.

All of that testimony is significant and I have quoted some of that before. But on the issue of the non-sterility of this IV drug, I believe the Testimony of Regina T. Brown, Consumer Safety Officer might be the most important. I will begin my discussion of her testimony in today's blog and continue it in later blogs this week.

In such testimony, Brown identified a series of problems with the way in which SPL (Baxter's supplier of heparin API) was producing heparin at the Changzhou SPL in China. She identified specifically these things about the way Heparin was being manufactured at Changzhou SPL:

That inadequate procedures were being followed to determine what was in the Heparin API,
That the tanks in which Heparin was being made were unsanitary,
Three that the centrifuges which were being used to separate out the Heparin from other raw materials were not calibrated; and
That no one on site had any real expertise in the manufacture of Heparin.

All of these issues point to the inference that this bad Heparin could have contained contaminants far more diverse than OSCS. Almost anything that goes through the small intestines of a pig could have been in that Heparin API. The NEJM of study in June of 2008,
"Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System" identified that the contaminated lots not only contained OSCS, but also another troubling compound: Dermatan Sulfate. But what of germs, other impurities or organic compounds that could cause a completely different but deadly disease process than OSCS?

In our next blogs, we will work thru the different issues identified by Regina Brown in her inspection of the Chanzghou SPL plant.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://thelegaltimes.net
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g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Heparin - Frequently Asked Questions - How Many People?

2009-03-24T13:05:00.000-07:00

9. How many people were poisoned?

Baxter still isn't giving a straight answer to this question, so we don't even know how many cases to fully investigate. But we want to create a ground swell of public opinion demanding full public disclosure. We do know that millions of vials of contaminated heparin were put into the health system. How many people were poisoned? We won’t know unless each and every case in which a person died or was severely injured who was on heparin is investigated.

Contact your Congressman, demanding answers. Write the FDA demanding answers. If you were part of Barack Obama's campaign, contact them or the Whitehouse. This is one of the most important issues impacting public health and the Federal Government must demand the same sort of answers that they are now demanding of AIG.

Heparin Frequently Asked Questions Continued

2009-03-22T10:15:00.000-07:00

More Frequently Asked Questions on the Baxter Heparin Catastrophe:

8. What if there was a death or a serious injury consequence from HIT?

HIT is short for heparin induced thrombocytopenia. See http://en.wikipedia.org/wiki/Heparin-induced_thrombocytopenia HIT is a condition where the body reacts to heparin causing the blood to clot. This clotting can result in death, serious injury such as gangrene and may leave survivors with severe consequences, such as amputations. The evidence is beginning to mount that OSCS may cause or exaggerate a HIT response or reaction. Thus, all cases of HIT after 2007. and up to this date, should be investigated.

We also are concerned that OSCS may cause a cumulative sensitization phenomenon, similar to what often happens with a bee sting. Most people experience little more than local pain and brief swelling with repeated stings by bees. Some people, however, become increasingly more sensitive until the person reaches the point of a severe allergic reaction or even death. In the case of OSCS, a second or later exposure may cause the catastrophic consequence. Thus, we are not ruling out a case where heparin was given during the presumptive contamination period – September 13, 2007 through April 30, 2008 – and then a catastrophic reaction to heparin occurred, even if the second dosage of heparin was not contaminated.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://thelegaltimes.net
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g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Heparin Frequently Asked Questions Part V

2009-03-19T09:52:00.000-07:00

Our recent blogs have been addressing Frequently Asked Questions. We have addressed:
1. When did the Baxter Heparin contamination begin?
2. When did Heparin return to being Safe?
3. How severe of a reaction should we have before calling?
4. What is the process should when I call the Johnson Law Office?
5. Will this Involve a Class Action?
Today, we continue with:

6. Are these Federal or State Court Actions?

Each plaintiff has a choice as to whether to file a non-class action case in Federal or State Court. The class action cases (non-severe consequences) are being handled in Federal Court. The Johnson Law Office, as well as our affiliated firm, The Nolan Law Group, are licensed in Illinois, the state where Baxter has its home office. Baxter has agreed to allow our claimants to bring these cases in Cook County, Illinois. Our litigation affiliate, The Nolan Law Group of Chicago, has a long track record of excellent results in Cook County, Illinois, including the Air Philippines case which was settled in 2007 for $165 million.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://thelegaltimes.net
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Heparin Frequently Asked Questions Part IV

2009-03-17T00:19:00.000-07:00

Our recent blogs have been addressing Frequently Asked Questions. We have addressed:

1. When did the Baxter Heparin contamination begin?
2. When did Heparin return to being Safe?
3. How severe of a reaction should we have before calling?
4. What is the process should when I call the Johnson Law Office?

Today, we continue with:

5. Will this Involve a Class Action?

There are two types of cases involving heparin: those where people had death or severe reactions and those where people had minor or imperceptible reactions. The first type of case should be handled as separate, individual cases. Clients hire a lawyer, who specifically investigates and handles the details of what happened. If serious injury or damage can be proved, then this particular claimant should receive specific economic damages for all losses that occurred, including wrongful death, survivorship claims, loss of society and companionship, medical expenses, funeral expenses, lost wages and pain and suffering. The Johnson Law Office is only handling cases involving serious injury and death.

A class action suit would be more appropriate for individuals who were administered contaminated Heparin where neither death or serious injury occurred.

The Johnson Law Office is not representing individuals in the class action. Other lawyers are handling cases where no tangible damage can be shown.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://thelegaltimes.net
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Heparin Frequently Asked Questions Part III

2009-03-15T20:30:00.000-07:00

For the last few days, we have been discussing Frequently Asked Questions. On previous days we have addressed:

1. When did the Baxter Heparin contamination begin?
2. When did Heparin return to being Safe?
3. How severe of a reaction should we have before calling?

Today, we continue with:

4. What Happens when I Call?

All Heparin calls are answered by my paralegal, Jayne Zabrowski, jayne@tbilaw.com If Jayne misses your call she will call you back if you leave a message. Jayne carefully listens to the details of how the death or serious injury occurred and will ask appropriate follow-up questions. Jayne cares and will sincerely listen to those who can benefit by our representation. If you have the type of case that we handle, you will then hear from the nurse paralegal who will assist in obtaining medical records and additional information.

Jayne has talked to every potential Heparin client, since our first client told us about a Heparin death in February of 2008. Melissa Scott had a severe reaction and died shortly after being administered Heparin during home dialysis. Jayne's hours of talking to victims makes her uniquely qualified to understand the pain that this poison has caused and is experienced at prioritizing the cases for investigation.

Jayne is one of the country’s best paralegals and comes to the Heparin claims after a decade of work with the debilitating complexities of representing brain injured people in the bulk of the Johnson Law Office’s case load. She annually attends the national trial lawyers convention (AAJ) each year and is very knowledgeable and experienced in forensic medical issues.

Heparin - Frequently Asked Questions Part II

2009-03-13T23:01:00.000-07:00

2. When did the Heparin return to being Safe?

Officially, all of the contaminated heparin should have been off the shelves by April of last year. However, recalling millions of vials of contaminated heparin is an enormously complex process, especially in hospital settings where different supplies of heparin may have been commingled. If the your loved ones death or catastrophic reaction after heparin fits the resembles an alergic reaction to a bee sting type, call us regardless of how recently the adverse event occurred.

3. How severe of a reaction should we have before calling a lawyer?

All cases of death should be investigated especially those after January 1, 2007 until the present day as I write this in March of 2009. Further, all cases of “severe consequences” should also be investigated. "Severe consequences” means adverse reactions involving significant additional medical care, hospitalization or damage to any body organ or limb.

For example, if heart damage occurred, you should call. If the heart stopped and the body was deprived of oxygen or blood flow for a documented period of time, you should call. If there was gangrene or injury to any limb, you should call. There may even be cases of amputation resulting from contaminated heparin. All such cases should be identified.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://thelegaltimes.net
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

Heparin - Frequently Asked Questions Part I

2009-03-13T13:07:00.000-07:00

Heparin FAQ's

The Heparin Catastrophe has left thousands of people with questions. We have heard most of them we over and over, and have done our best to answer those we could. Many answers are still unknown. In those thousands of heparin conversations, we have been asked tens of thousands of questions. Below and the series of blogs to follow are our answers to the most frequently asked questions.

1. When did the Heparin contamination begin?

Baxter claims it started shipping contaminated Heparin on September 13, 2007, but we believe there is at least circumstances that make us believe that it may have started sooner. This September 13, 2007 start date means that any death or severe consequences occurred in the administration of heparin after that date, requires an investigation. Baxter claims to have tested all heparin shipped from China, even going back years and has alleged that the OSCS contaminant began on that date. But the conditions that allowed for this contaminant and didn't properly test for it, leaves doubts as the purity of Heparin even before that date.

While at one time we felt fairly comfortable turning down cases that occurred before that time, we are no longer doing so just based on that September date. As additional disclosures have trickled in, we are seeing more and more evidence that clearly suggests some contaminated heparin was in the supply chain earlier in 2007, especially in hospital settings, such as in cardiac surgery. If you know of a death or severe consequence following heparin administration at any time in 2007, call us and we will investigate.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
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http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

FDA Use of Private Inspectors Raises Doubts

2009-03-06T22:16:00.001-08:00

As if they had been reading this blog, the New York Times and the Rachel Maddow Show today blasted the FDA's "chicken guarding the hen house" choice of inspectors. The FDA has allowed industries being inspected to be the ones who hired the FDA inspectors. For the Rachel Maddow video, see http://www.msnbc.msn.com/id/26315908/#29561173

The New York Times, at http://www.nytimes.com/2009/03/06/business/06food.html?_r=1 said:

"With government inspectors overwhelmed by the task of guarding the nation’s food supply, the job of monitoring food plants has in large part fallen to an army of private auditors like Mr. Hatfield. And the problems go well beyond peanuts."

The total abrogation of its responsibility to regulate has left both of the FDA's mandates - food and drugs - vulnerable. The NY Times article highlights peanuts and salmonella. The Heparin Catastrophe is the poster child for what is wrong with the FDA's drug inspections. But the spirit of deregulation has harmed Americans in virtually all aspects of their lives.

One must ask, what was the SEC doing all those years, giving Bernie Madoff and Citibank, clean bills of health? What was the Justice Department doing worrying about Martha Steward and not Wall Street?

Ronald Reagan's infamous quote: "government is not the solution to our problem; government is the problem" has left a legacy of a broken economic system, grossly disproportionate income distribution, corruption, and now, disease. We must allow government to go back to monitoring business. We must stop the absurd out cry outcry against a mild return to a progressive tax system. And we must use the Justice Department to prosecute crimes, not curry politic favor. For those who have been killed or made sick by Baxter's greed, there must be justice.

Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
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http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009

FDA and Heparin Inspections

2009-03-06T07:03:00.000-08:00

Yesterday, I railed against the FDA’s increasing inability to assure that our drug supply is pure. Earlier this week, our blogs quoted a familiar name, Janet Woodcock, about some of those same failings. Woodcock should be a familiar name to those who have followed the Heparin Catastrophe. It was Woodcock who last year testified to Congress about foreign inspections, the in wake of first reports of Heparin deaths.

Last year, Woodcock explained the new and improved approach of the FDA to Congress as follows:

FDA conducted more foreign inspections in Fiscal Year (FY) 2007 than any other in the Agency’s history. For example, in FY 2007, FDA conducted 332 inspections of foreign drug manufacturers, compared to 260 in FY 2004, 266 in FY 2005, and 212 in FY 2006. We plan to conduct 500 in FY 2009. While, inspections are an important component of the Agency’s systematic approach to ensuring the safety of imported medical products, they alone cannot fully address these challenges.

Beyond Our Borders Initiative. The FDA Beyond Our Borders Initiative is a multi-pronged approach to promote and verify compliance of imported food, cosmetics, and medical products with FDA requirements. This Initiative includes increased FDA presence in China, increased FDA inspections, greater sharing and use of foreign competent authority inspection reports and other information, use of third party certification, and increased capacity building with countries that have less developed regulatory systems to ensure product safety.

Foreign Presence. China is one of the largest exporters of drug products for the U.S. market. Recently, FDA and HHS leadership, the Department of State, and the U.S. Ambassador to China committed to establishing an FDA office in China this year. On March 8, 2008, the Department of State approved FDA to place 13 total staff in China (eight FDA personnel and five Foreign Nationals). This staff will be responsible for building closer working relationships with our Chinese counterparts, carrying out inspections, and working with Chinese inspectors to provide training. FDA is in the process of making the necessary arrangements and preparing to hire staff. This effort builds on two recently-signed Memoranda of Agreements (MOA) with two Chinese FDA counterpart agencies that facilitate broader access to Chinese production facilities on an expedited basis. This is a significant step toward ensuring the safety and efficacy of medical products produced for the U.S. market.

FDA’s efforts will build stronger cooperative relationships with counterpart agencies in China, enhance technical cooperation with these agencies, and foster the flow of information between regulatory systems. Having an overseas presence in China will improve our ability to inspect facilities in China and, very importantly, foster greater interactions between FDA staff and Chinese manufacturers to help ensure that products shipped to the U.S. meet FDA standards for safety and manufacturing quality. In addition, FDA is working to establish beneficial collaborations with India, another large exporter of drug products to the U.S.

Well, the Heparin Catastrophe demonstrates how flawed the FDA’s approach has been. Eight American inspectors for all of China? The goal is to increase inspections from 300 to 500? That is like having 500 auditors for the entire IRS. And I wonder how many of those eight people will speak Chinese?

The Congressional hearings told about the horrors of Chinese drug facilities, just in terms of basic things like cleanliness, not even to mention sterility. Hopefully, massive increases in inspections will at least address those concerns. What good is it for doctors to wash their hands if the drugs they give aren’t sterile?

But the biggest problem the FDA faces is purity. While that sounds like the same thing, I refer to the sterility issue as assuring that bacteria or viruses don’t contaminate drugs. By purity, I mean that the drugs are diluted by a substance that is put in there to dilute the drug, by using cutting agents that are being cleverly disguised to look like the real thing, such as with OSCS and Heparin. The problem with the cutting agents that are disguised to look like the real thing is that these compounds are not innocuous like sugar,. They are in fact complex organic compounds that may have very complex and poorly understood consequences.

But just imagine that the cutting agent was as innocuous as sugar. Well, that would be fine if you weren’t giving it to a diabetic. The problem with any cutting agent is you don’t know who will be hypersensitive to it. The FDA can impose all of the stringent trial and research requirements it wants before approving a drug, but if what is actually sold under that label, isn’t pure, it is a disaster.

You are not going to catch clever counterfeiters with inspections. This type of misconduct can only be detected by rigorous and ever more vigilant testing for purity. It may never be practical to catch each new and progressively more clever attempt to dilute the purity of drugs. Which is why we should not allow any drug to be imported. But if that is too protectionist for the free marketers, and our global trading partners, then at a minimum we must ban the importation of drugs used for intravenous or other sterile administration.

As all Baxter does, according to its Chairman Robert Parkinson is, “manufacture products that are injected or infused or inhaled by patients who need them to stay alive," Baxter should never have imported any part of what it sells. Baxter should begin its reparations for poisoning Americans by leading the U.S. drug industry towards this type of protectionism – protecting the American patient.
Attorney Gordon Johnson
http://heparin-law.com
http://tbilaw.com
http://waiting.com
http://vestibulardisorder.com
http://youtube.com/profile?user=braininjuryattorney
g@gordonjohnson.com
800-992-9447
©Attorney Gordon S. Johnson, Jr. 2009