Baxter | Heparin Deaths

After $500 Million Judgment, Teva Says It Will Stop Making The Anesthetic Propofol

Posted on 29th May 2010 by gjohnson in Uncategorized

Baxter, FDA and propofol, propofol suit, Teva and Baxter negligence suit, Teva Pharmaceutical Industries, Teva-Baxter product liability suit

Less than a month after a jury ordered Teva Pharmaceutical Industries to pay $360 million in a product liability/negligence case involving propofol, the drug giant said it will stop making the anesthetic. http://online.wsj.com/article/SB10001424052748704269204575270900368773506.html?KEYWORDS=Teva+and+propofol

In a statement to federal regulators last week, Teva announced it was stopping production of propofol, according to The Wall Street Journal.

It’s no wonder that Teva is dropping the drug, which has been under fire by federal officials and consumers alike.

Most recently, just earlier this month, Teva and Baxter Health Care Corp. lost a suit filed by a Nevada man who contracted hepatitis C after undergoing a routine colonoscopy where he was anesthesized with propofol.

http://heparin-law.com/blog/2010/05/jury-orders-baxter-teva-to-pay-500-million-in-largest-award-in-nevada%e2%80%99s-history.html?preview=true&preview_id=528&preview_nonce=f654a8d83e

In that case, a jury in Las Vegas awarded Henry Chanin and his wife half a billion dollars in punitive damages, the largest award in Nevada’s history. Teva was ordered to pay $356 million, while Baxter was hit for $144 million.

As many as 114 patients were infected with hepatitis C, when medical workers used single-dose vials of propofol on more than one patient, spreading the incurable disease to those undergoing colonoscopies. Chanin’s lawyer is representing 40 other patients who contracted hepatitis from the vials, and another 4,500 who were among 50,000 who got notices that they may have been exposed to hepatitis during their colonoscopies.

Teva has had other problems with propofol. The pharmaceutical company had to recell some of the anesthetic last July when high levels of toxins wre found at its Irvine, Calif., plant. The Food and Drug Administration in a letter in December told Teva that it had found “significant” violations at that plant, according to The Journal.

In its statement last week saying it was ending its manufacturing of propofol, Teva said, “Our data supports that these products, when used and stored as directed, continue to be safe and effective and perform within the appropriate specifications.”

Propofol and a combination of other drugs were blamed for causing the death of singer Michael Jackson, who used the anesthetic to help him sleep.

Propofol is widely used for surgeries across the country, and federal officials have been worried that there might be a shortage of the anesthetic. So Teva’s news has federal regulators worried, despite the past problems the drug maker and the FDA have had over the drug.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
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Teva, Baxter Acted Out of Corporate Greed, Sparking The Biggest Recorded Hepatitis Outbreak In History

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Posted on 12th May 2010 by gjohnson in Uncategorized

Baxter, heparin, hepatitis C outbreak, hepatitis outbreak, hepatits C, Teva

Last week a Las Vegas jury delivered the largest award ever, $500 million, in the state of Nevada’s history. That’s a very generous verdict, rendered – I think – because the panel believed that two giant drug companies valued their profits much more than the public’s safety. http://www.lasvegassun.com/news/2010/may/07/jurors-reach-verdict-over-hepatitis-c-damages/

As I wrote in a blog yesterday, the judgment was awarded in a case where a man in his 60s went to a clinic in 2006 for what should have been a routine colonoscopy. He left with an incurable liver disease, hepatitis C.

That man, Henry Chanin, and his wife Lorraine won $356 million in punitive damages from Teva Parenteral Medicines and $144 million from Baxter Health Care, the manufacturer and distributor, respectively, of the anesthetic propofol. Teva and Baxter plan to appeal the verdict.

The case raises many questions about corporate responsibility and safety. Baxter is no strange to such questions. It faces a flood of lawsuits from survivors of people, estimated in the hundreds, who died after getting doses of contaminated heparin, a blood thinner, that was imported to the states from China in 2008.

Last week’s $500 million verdict is only the beginning for Teva and Baxter. There are dozens of lawsuits stemming from the hepatitis C outbreak pending against the two pharmaceutical giants, but the Chanins’ case was the first to go to trial. After the award in their trial, if I was representing Teva and Baxter, I would advise them to settle those other lawsuits, pronto.

Patients at several facilities, including the Desert Shadow Endoscopy Center, were exposed to HIV and hepatitis strains C and B when single-dose vials of propofol were used on multiple patients after the vials had been contaminated by nurses reusing syringes on the same patients.

During the opening statements in April for the four-week trial on the Chanins’ lawsuit, attorneys told the jury that Teva and Baxter’s negligent actions sparked the largest recorded hepatitis outbreak in history. http://www.lvrj.com/news/lawer-targets-drug-companies-in-hepatitis-case-opening-statements-91533874.html

Henry Chanin’s lawyer, Robert Eglet, said that a company called SICOR Pharmaceuticals opted to sell propofol in 20 milliliter and 100-milliter vials in order to boost its production and profits. As a result, SICOR was sold at a premium price, $3.5 billion, to Teva in 2003.

But there was a problem with the 50-millimeter vials: That large a dose was enough to knock out a 600-pound gorilla, an anesthesiologist testified at the trial. A human would only need to get 10 to 20 milliliters of the drug in order to undergo a colonoscopy. http://www.lvrj.com/news/doctor-in-endoscopy-trial-testifies-vials-of-sedative-were-too-large-91684569.html

Rather than throw out the leftover propofol in a vial, medical workers were tempted to re-use the single-use vials, which became contaminated when nurses reused syringes on the same patient.

”The pharmaceutical companies were responsible for providing 50 milliliter vials of propofol to ambulatory centers that would require no more than 10 milliliter to 20 milliliter bottles because profit dictated the decision to do so,” Eglet said in a statement after the jury’s verdict. “The larger size vials encouraged multi-dosing becoming weapons of mass infection.”

Teva and Baxter could have remedied the situation. Eglet pointed out that there were 148 reported cases of hepatitis C contamination throughout the U.S. and globally – all before Chanin contracted the disease – and yet Teva and Baxter didn’t take any action. If they had, Chanin would not have the chronic liver disease today.

It was also unfortunate for those who became infected in Nevada because of “double-dipping” in those large vials.

Teva and Baxter were acting out of greed, the public be damned. So many, many people because infected in Nevada, all because of nurses “double-dipping” in those large, cost-effective vials.

Even though the $500 million award is a tidy sum, it’s almost a drop in the bucket to Teva and Baxter, which combined made $13.4 billion last year.

“The $500 million verdict represents two weeks of income to these companies,” Eglet said. “The jury understood the importance of sending a message to stop putting profit over patient safety and making sure this never happens again.”

Jury Orders Baxter, Teva to Pay $500 Million In Largest Award in Nevada’s History

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Posted on 11th May 2010 by gjohnson in Uncategorized

Baxter, Henry Chanin, heparin, hepatitis C, largest Nevada award ever, Lorraine Chanin, Robert Eglet, Teva

Baxter Health Care Corp. and Teva Parenteral Medicines were asked to pay a mere $1.7 million to settle a lawsuit filed against them by a Nevada man who contracted hepatitis C after undergoing a routine colonoscopy. The two drug giants ignored the offer, according to Robert Eglet, the plaintiff’s attorney. http://www.lasvegassun.com/news/2010/may/07/jurors-reach-verdict-over-hepatitis-c-damages/

Well, hindsight is 20/20, as they say. That’s because last Friday a Clark County District Court jury in Nevada awarded Henry Chanin and his wife a half a billion dollars in punitive damages. Teva was ordered to fork over $356 million and Baxter was hit for $144 million, a whopping $500 million total.

That’s the largest award in Nevada’s history.

The Chanins’ complaint against Teva and Baxter alleged product liability, negligence and disregard of known and accepted medical procedures, resulting in Henry Chanin contracting hepatitis C from exposure to contaminated vials of the anesthetic propofol. Baxter was the distributor and Teva the manufacturer of the drug.

This hepatitis case isn’t the only litigation that Baxter has pending against it. The drug maker also faces a barrage of lawsuits stemming from hundreds of people dying after taking tainted heparin, the blood thinner, that had been imported from China in 2008.

Both Baxter and Teva said they plan to appeal the $500 million jury verdict in Nevada, which stems from a hepatitis C outbreak two years ago.

Patients were exposed to HIV and hepatitis strains C and B when single-dose vials of anesthesia medication, propofol, were used on multiple patients. Nurse anesthetists were re-used syringes to withdraw medication from the single-dose vial, creating a back flow of blood resulting in contamination. http://www.lvrj.com/news/teva-plans-appeal-of-hepatitis-verdict-93223949.html

Teva maintains that it has done nothing wrong.

“Teva is reviewing the full judgment and continues to believe that the evidence shows the company acted responsibly,” the drug maker said in a statement.

“The label for its propofol product clearly states that it is for single patient use only and that aseptic procedures should be used at all times. “ Teva said. “Further, the company believes that the Jury should have been allowed to hear all of the evidence in this case. Teva believes that the evidence clearly showed that if the plaintiff contracted hepatitis as alleged, it was because a properly labeled product was blatantly misused at the clinic in question. Teva believes that there are numerous grounds for appeal, and plans to contest the verdict vigorously.”

Anywhere from nine to 114 patients were infected with the incurable disease. In addition to Chanin, Eglet represents 40 more patients who contracted hepatitis C and another 4,500 who were among the 50,000 people who had gotten colonoscopies at the Nevada clinic in question and were notified that they needed to be tested. Not the kind of message you ever want to get.

Chanin’s story is particularly heartbreaking, which is perhaps why the Nevada jury was so generous. He is the headmaster of The Meadows School, a private school founded by Carolyn Goodman, wife of Las Vegas Mayor Oscar Goodman.

Chanin went to the Desert Shadow Endoscopy Center in June 2006 for a colonoscopy, and in addition to having that routine procedure he contracted hepatitis C.

During a four-week trial that started April 19, Chanin said that he and his wife had stopped having sexual relations, for fear that he would spread the disease to her.

”A $1.7 million offer of judgment to settle was ignored by the defense bringing the Chanin’s to this point,” Eglet said in a press release.

“At the core of this case is the responsibility of the pharmaceutical companies as well as that of the health care professionals,” he said. “The conduct of the doctors and nurses demonstrated a disregard for human life in the reuse of contaminated vials and syringes. Equally, the pharmaceutical companies were responsible for providing 50 ml vials of propofol to ambulatory centers that would require no more than 10ml to 20 ml bottles because profit dictated the decision to do so. The larger size vials encouraged multi-dosing becoming weapons of mass infection. The result is nearly immeasurable.”

Before Friday’s verdict, Henry and his wife had already been awarded compensatory damages of $3.25 million and $1.85 million, respectively.

I’ll be writing more about the details of this case, and the significance of the vial sizes, this week.

Baxter’s Heparin Contamination – More on SPL Inspection

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Posted on 29th March 2009 by gjohnson in Uncategorized

Baxter, Chanzghou SPL, FDA recall of Heparin, heparin and punitive damages, heparin attorney, Heparin deaths, heparin recall, House Subcommittee on Oversight and Investigations

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.

Heparin Contamination – Flawed Processes to Determine Purity of the Drug

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Posted on 28th March 2009 by gjohnson in Uncategorized

anaphylactic heparin reaction, Baxter, Baxter recall of heparin, FDA problems, FDA recall heparin, heparin, heparin attorney, heparin lawyer

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.

FDA and Heparin Inspections

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Posted on 6th March 2009 by gjohnson in Uncategorized

anaphylactic heparin reaction, Baxter, Baxter recall of heparin, drug counterfeiting, FDA recall of Heparin, hemodialysis allergic reactions

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.

Army creates team to review security at biolab

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Posted on 8th August 2008 by gjohnson in Uncategorized

anaphylactic heparin reaction, anthrax, Baxter, Baxter Heparin Wrongful Death case Illinois, Chinese toxic imports, FDA recall of Heparin, heparin

We could have filled this and other blogs this week with all of the news and commentary about Anthrax. But what does that have to do with the Heparin Catastrophe. It just drives home even harder, the point we have been making on this blog since February that any firm in the pharmaceutical industry had to do the utmost to insure absolute purity of its drugs. Not only has there been on the front burner of the FDA agenda the risk of counterfeit drugs, but more seriously, the risk of intentional tampering, with malicious intent. Any company that makes drugs, must make them with such utmost security, that no opportunity to infect large numbers of people could exist.

That reality is even more important with a product like Heparin, that is designed to be taken, not only intravenously, but also given to our sickest individuals, those on kidney dialysis. Nothing less than an absolute guarantee of purity is required, and exporting the manufacture of raw materials and expecting a federal agency that has a 30 year backlog, is not the way to do it.

Attorney Gordon Johnson
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©Attorney Gordon S. Johnson, Jr. 2008

Date: 8/8/2008 7:53 PM

By LOLITA C. BALDOR
Associated Press Writer

WASHINGTON (AP) _ The Army has created a team of medical and other military experts to review security measures at the research laboratory where the scientist linked to the anthrax mailings worked.

Army Secretary Pete Geren has asked at least a dozen military and civilian officials to scrutinize safety procedures, quality controls and other policies and practices at the biodefense lab at Fort Detrick, Md., Army spokesman Paul Boyce said Friday.

To date, the Army has offered no explanation for how its biosecurity system, which is set up to catch mentally troubled workers, failed to flag scientist Bruce Ivins for years. Ivins, the microbiologist accused of sending anthrax-laced letters in 2001 that killed five people, committed suicide last week as the FBI began closing in on him.

Boyce said Friday that Geren met with military officials on Thursday night, then traveled to the high-security Army Medical Research Institute of Infectious Diseases, known as USAMRIID, at Fort Detrick on Friday morning to talk with leaders there.

Boyce said the team, which is only now being formed, is not targeting individuals but instead will be reviewing documents, procedures and other safety measures to ensure security at the military biodefense lab. He added that as yet there are no deadlines for reports from the team.

The facility has come under intense public scrutiny as more details have spilled out about therapists’ concerns that in recent years Ivins had become paranoid, delusional and bent on violence.

Investigators said that between 2000 and 2006, Ivins had been prescribed antidepressants, antipsychotics and anti-anxiety drugs. By 2005, the government had matched anthrax in his lab to the strain that killed five people.

It wasn’t until November 2007, after the FBI raided his home, that Fort Detrick revoked Ivins laboratory access.

Army officials have declined to discuss any other efforts to either watch Ivins more closely or put other restriction on him prior to the November action.

Instead, they have stressed that safety procedures at the lab have included ongoing personnel evaluations, which rely largely on employee self-reporting medical or criminal problems and observations by other workers and supervisors.

Boyce said the impending review will be headed by a two-star general, and will include representatives from the medical research command, the Army’s surgeon general, and Army operations.

While the lab has strict security measures meant to weed out troubled scientists, there are lingering questions about why it took so long for supervisors to restrict Ivins access to the deadly toxins.

Ivins’ attorney, Paul F. Kemp, says the government’s evidence was too weak to trigger any action.

But members of Congress have questioned whether adequate action was taken, and they have pledged to investigate the case and lab security as a whole.

Overall, there are nearly 1,400 biological defense labs, with an estimated 14,000 scientists working with the world’s deadliest pathogens.

In 2005, the Pentagon ordered new “biosurety” safeguards requiring workers such as Ivins to be “mentally alert, mentally and emotionally stable.” The program was meant to ferret out workers with mental problems and those who attempted or threatened suicide.

Colleagues have differed in their observations of Ivins, with some saying they never say signs of mental illness, and others describing him as a “manic basket case” or saying they’d seen him openly weeping at his desk.

Ivins himself wrote in a July 2000 e-mail that he might be suffering from a paranoid disorder.

“I get incredible paranoid, delusional thoughts at times, and there’s nothing I can do until they go away, either by themselves or with drugs,” he wrote that August, in an e-mail included in government documents released Wednesday.

Copyright 2008 The Associated Press.

FDA faulted over unapproved uses of medications

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Posted on 27th July 2008 by gjohnson in Uncategorized

Baxter, drug company abuses, FDA, heparin, unapproved drug use

Date: 07/27/2008 05:03 AM

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators.

It typically takes four more months for the company to fix the problem. During that time, a lot prescriptions can be written.

The report from the Government Accountability Office delves into a gray area of medical practice and federal oversight: the use of medications to treat conditions other than the ones the drugs were approved for, a practice known as “off-label” prescribing.

Although widely accepted, off-label prescribing can amount to an uncontrolled experiment. While some patients benefit, others get drugs that do not do them much good and end up wasting their money. Some people have been harmed by unexpected side effects.

What makes the practice so difficult to get a handle on is a web of seemingly contradictory laws and regulations.

Drug companies are forbidden to promote medications for uses that have not been validated by the Food and Drug Administration on evidence from clinical trials. Doctors, however, can use their own independent judgment in prescribing medicines. Also, under guidance proposed by the FDA this year, drug companies could distribute to doctors scientific articles that suggest new and unapproved uses for medications.

The situation has raised concerns for Sen. Charles Grassley, R-Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes.

The review that Grassley requested found the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.

Copyright 2008 The Associated Press.

Heparin Disaster -FDA Inspections Weren’t Sufficient to Rely on Safety of Drug

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Posted on 17th July 2008 by gjohnson in Uncategorized

anaphylactic heparin reaction, Baxter, Baxter Heparin Wrongful Death case Illinois, Chinese toxic imports, heparin

One of the lingering excuses for the Heparin Disaster is that it was the FDA’s responsibility, not the manufacturers, to make sure that Heparin was safe. That is like Wesley Snipes blaming overworked auditors for his tax fraud.

The risk factors of counterfeit drugs are known not only by drug companies like Baxter and SPL, but by the public at large. Every time we struggle to open a sealed package of anything we are reminded of why these seals are on these products: to avoid tampering. The risk of tampering and counterfeit are not something that can be transferred to an imperfect government auditing system, especially in light of what insiders have been saying for years about the thoroughness of FDA inspections.

In previous blogs, we have discussed the testimony before Congress: “Weaknesses Place Americans at Risk” Subcommittee on Oversight and Investigations held April 22, 2008. Click here for those hearings:http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.DrugInspection.shtml

During such hearings, Benjamin England, a former FDA inspector testified as to how inadequate the current FDA was to keep up with the problem of inspections.

Click here for those England’s testimony: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042208.England-testimony.pdf
In his testimony England described his background as follows:

I am founder and owner of an FDA consulting practice, FDA Imports.com, Inc., and a practicing attorney representing foreign and domestic food, drug, medical device and cosmetic companies in matters involving the U.S. Food and Drug Administration (FDA). I am a 17-year veteran of the U.S. Food and Drug Administration (FDA). From 1986 to 2003 I held the positions of Regulatory Microbiologist in FDA’s Baltimore Microbiology Laboratory, Consumer Safety Officer and Compliance Officer in FDA’s Baltimore District Office, Special Agent with FDA’s Office of Criminal Investigations in the Miami Field Office, Compliance Officer in FDA’s Miami Resident Post, and Regulatory Counsel to FDA’s Associate Commissioner for Regulatory Affairs (or ACRA) in Headquarters. I resigned my most recent FDA position as Regulatory Counsel to the ACRA in July 2003 — a position I held in FDA for over three years as a Title 42 appointee.

In his testimony, England stated:

Today we are confronted with serious adverse events involving a widely used drug product that appears to have been made using substituted active ingredients at a foreign facility that was never inspected by FDA – because of some human error in deciding whether an inspection had already been conducted or should be conducted. I believe that we are truly on the brink of a series of these events and that waiting for FDA to take some action that actually mitigates risk or encouraging the agency to act unilaterally will be an exercise in futility. As I said in the press and to your staff, Mr. Chairman, this recent case appears to be the close cousin of the same conduct discovered nearly two decades ago. At that time, it was through intensive and smart facility inspections and by the efforts of forward thinking forensic scientists and investigators the activity was discovered. Moreover, the successfully prosecuted counterfeit bulk drug case was made possible only through the intellectual connections between certain domestic inspections at U.S. facilities by a keen FDA investigator who had previously conducted the foreign inspection of the bulk supplier, coupled with follow up inspections at the foreign supplier, which were themselves targeted with knowledge of where evidence of illegal conduct was likely to be found.

It is no different today – except that we now have available to us significantly improved technological solutions that may prove useful to more precisely and efficiently identify, target, and intercept safety risks prior to their realization in the market place.

In our next blog, we will discuss England’s perspective on the FDA’s failures to use those technological advances to prevent tampering and contaminants in imported drugs.

Baxter CEO Admits Responsibility for Heparin Disaster, Irrespective of Wrongdoing in China

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Posted on 13th May 2008 by gjohnson in Uncategorized

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Robert Parkinson, CEO of Baxter International, Inc. admitted in Congressional testimony on April 29, 2008 that because of the vulnerable patient population that receives Baxter’s products, that Baxter and he are responsible for this disaster, regardless of how and when the contaminant OSCS got into the Heparin. Parkinson, testifying in front of House Oversight and Investigations Subcommittee, under oath, at 3:46 into the Hearing stated the following:

“Baxter has built its reputation over 75 years by consistently preparing quality products for critically ill patients.

“We deeply regret this has happened and I feel a strong sense of personal responsibility.

“I feel this because of who we are and what we do.

“Each day there are over 6 million infusions of Baxter products around the world to patients with life threatening conditions..

“We are not a traditional, pharmaceutical company. We don’t make pills or tablets. We don’t do direct to consumer advertising. And we don’t make lifestyle drugs.

“We develop and manufacture products that are injected, infused or inhaled, by patients who need them to stay alive. They have to be safe and effective each and every time.

“Because our products are used in critical care environments, they have to be safe and effective every time, no matter what the reason.

“This is my responsibility because Baxter’s name was on the product.”

These statements form the fundamental basis of the lawsuit claims against Baxter International. Since the target patient population for all of Baxter’s products are so medically vulnerable, Baxter had to take all precautions to assure safety. According to the FDA, the precautions being taken in China were insufficient to identify contaminants or impurities.

With all that is known in the pharmaceutical industry about counterfeiting, Baxter should have been doing more sophisticated testing for counterfeit or contaminant ingredients. Frankly, considering the now publicly apparent problems in regulating anything made in China, nothing that Baxter produces should be made from Chinese raw materials.

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