Colorado Personal Injury Blog - FDA & Prescription Drugs

Beef Bouillon Recalled Due to Allergy Alert

Chrissie Cole — Fri, 25 Sep 2009 12:14:00 GMT

Associated Brands announced a voluntary recall of some “Price Rite Beef Flavored Cubes” because they may contain dairy allergens, according to the U.S. Food and Drug Administration (FDA).

The recall involves 320 cases (about 3,840 selling units) with a UPC Code of 41190 75581 on the label. The lot code, on the top of the jar says 22 JUL 11.

Consumers who have an allergy to milk may be at risk of a serious or life-threatening allergic reaction if they consume foods made with the recalled item.

To date, there have been no reports of illnesses or allergic reactions associated with the recalled products.

Originally posted at InjuryBoard by Chrissie Cole

The Heparin Debacle Part Four – Baxter International Getting Away with Murder?

Linda Snyder — Wed, 07 May 2008 16:42:12 GMT

Getting away with murder? That’s a pretty harsh question to ask when talking about a drug company. But, I question the policy of drug maker, Baxter International to leave a product on the market for as long as possible before issuing a recall. I’ve heard their arguments, that because the side effects are so rare that more patients are being helped that being harmed. That’s an argument that almost makes sense until you talk to the families of the 785 patients that suffered from severe adverse reactions and 81 patients that have died since January 2007.

To help put those numbers in perspective, according to the FDA report, Information on Adverse Reports and Heparin, of those 81 heparin related deaths, 66 deaths occurred between October 2007 and February 2008. In contrast, there were only 3 heparin related deaths for the entire year of 2006.

In October 2007 there were 4 heparin related deaths reported to the FDA. That’s more than the entire year of 2006. In November 2007 there were10 heparin related deaths. In December 2007, 13 deaths, that’s over 4 times as many deaths as the entire year of 2006. In January 2008, 21 deaths and February 2008 there were 18 heparin related deaths. There were no deaths reported in March 2008.Yet it took the FDA and Baxter over four months to issue a recall. If the recall had been issued in November 2007, 52 deaths might have been prevented.

The FDA does state in its report:

• That the heparin related deaths in the report “concern heparin produced by any manufacturer.”

• The fact that someone reports an adverse event does not necessarily mean that a specific drug caused the medical event or death.

      • Reports have to be analyzed to see if there is a plausible causal association between the drug and the medical event.
       •It is often not possible to tell in an individual case if there is a causal relationship between the drug and the medical event or death.
        • Many patients have other serious conditions that could have caused the reported problem.

Is Baxter guilty of murder? According to Wikipedia murder is legally defined as:

…a common law murder is defined as the unlawful killing of a human person with malice aforethought if the defendant acts with any of the following states of mind:

(i) Intent to kill; (ii) Intent to inflict serious bodily harm; (iii) Reckless indifference to an unjustifiably high risk to human life (abandoned and malignant heart); or (iv) Intent to commit a felony (felony-murder doctrine).

Under element (iii) abandoned and malignant heart, the killing must result from defendant's conduct involving a reckless indifference to human life and a conscious disregard of an unreasonable risk of death or serious bodily injury.

Reckless indifference to human life…allowing an additional 52 people die sounds like reckless indifference to me.

Originally posted at InjuryBoard by Linda Snyder

Let the FDA Do Its Job? I Don't Think So.

Linda Snyder — Fri, 02 May 2008 13:49:13 GMT

What planet does Diane Bieri live on? It’s certainly not on the planet earth that I live on. In her commentary, Opposing view: Let FDA do its job, Ms. Bieri goes on and on about how the outcome of a U.S. Supreme Court case will undermine the FDA and it’s the patients who will suffer.

Ms. Bieri claims that we should not “ignore the FDA’s scientific expertise,” and “we should empower the FDA to accomplish the job Americans expect.”

As an “American” here’s what I expect from the FDA. I expect the FDA to not allow drug research studies to be ghost written for the doctors by the drug companies. I expect the FDA to inspect foreign drug plants. I expect the FDA to not approve drugs that have known potential adverse side effects without comprehensive warning labels. I expect the FDA to not allow drug makers to dictate when a drug be recalled that has reports adverse effects or deaths. I don’t expect to have the FDA run by the drug companies.

Ms. Bieri continues, “Now, lawyers are trying to second-guess FDA's expertise regarding the way to warn about potential drug risks.” All I can say to that comment is, thank God for lawyers! Historically the drug companies will not issue a recall or change a warning label until attorneys get involved and file lawsuits on behalf of patients who have suffered from adverse events or have died.

The drug companies are terrified of losing revenue. If, we as patients are more informed about potential adverse effects, we may decide that all of those glorious benefits that we see in the polished television commercials and glossy magazine ads are not worth the risk. A patient who makes an informed decision has the ability to affect the drug companies’ bottom line.

In light of the heparin debacle, the ghost written Vioxx studies and the Vytorin and Zetia mess, I find it appalling that anyone thinks the drug companies need less regulation and that the FDA as it exists today is functioning in the best interests of patients.

Oh, wait a second…Diane Bieri is senior vice president and general counsel of PhRMA (the Pharmaceutical Research and Manufacturers of America).

Originally posted at InjuryBoard by Linda Snyder

The Heparin Debacle Part Three - The FDA Falls Flat

Linda Snyder — Wed, 30 Apr 2008 06:00:00 GMT

“Protecting and Promoting Your Health.” That’s the tag line posted on the U.S. Food and Drug Administration web site. Protecting and promoting your health, doesn’t seem to have the same meaning to the FDA as it does to the U.S. consumer.

Putting it very simplistically, the FDA is charged with ensuring that the food and drugs we consume are safe before they are made available to the public. Recent news has shown that many of the drugs that the FDA has approved have not only not failed to "protect and promote our health," but in fact have deadly consequences.

Consider these facts:

• FDA approved drugs, Oxycodone, Fentanyl and Clozapine, are on the list of top 10 deadliest drugs and are responsible for over 12,000 deaths from 1998 to 2005.
• The American College of Cardiology has recommended that the popular FDA approved drugs, Vytorin and Zetia should only be used after all other cholesterol lowering drugs fail.
• A recently published article in the Journal American Medical Association (JAMA) claims the drug maker Merck drafted many of the research studies for their best selling FDA approved drug Vioxx, then had prestigious doctors put their names on the reports prior to publication.

According to a report from the Government Accountability Office, the FDA would need to spend at least an additional $56 million next year in order to fully inspect foreign plants. The FDA would need at least $15 million a year to inspect Chinese drug plants every two years to comply with US standards.

At its present pace, it would take the FDA nearly 27 years to inspect every foreign manufacturer that exports medical devices to the US. It would take 13 years to inspect every foreign drug plant and 1,900 years to inspect every foreign food plant.

Although the Bush administration acknowledges the problem, President Bush’s budget does not provide the FDA with the funds to hire additional inspectors. There are proposals in motion to increase the FDA’s budget and to shift some of the financial burden onto the domestic and foreign manufacturers to pay fees for inspections.

I don’t know about you, but now when I go to my medicine cabinet and take out that bottle of FDA approved prescription medication that I assumed was safe, because the FDA’s motto is “Protecting and Promoting Your Health”, I get a funny feeling in the pit of my stomach that no medication can fix.

Up Next: The Heparin Debacle Part Four – Is Baxter International Getting Away with Murder?

Originally posted at InjuryBoard by Linda Snyder

The Heparin Debacle Part One

Linda Snyder — Tue, 22 Apr 2008 20:50:42 GMT

Remember what it felt like as a kid when you went into a candy store and you were overwhelmed with how many choices of sweets lay before you? When I read the New York Times article, U.S. Identifies Tainted Heparin in 11 Countries, I felt that same overwhelming indecision, but in a bad way. I was baffled by which angle to take. Do I blog about how the Chinese are trying to pass the buck and blame everyone else for the contaminated Heparin. Do I blog about how the FDA is dismally understaffed to even consider inspecting foreign plants. Do I blog about how huge this Heparin debacle is turning out to be or do I blog about how Baxter International, the manufacturer of Heparin, is more concerned with covering their corporate behinds and is denying that the contaminated drug has caused 81 deaths.

So, I decided to do what any smart kid in a candy store would do…sample a little bit of everything…

In a nutshell, the FDA has found the contaminated drug Heparin, a blood thinner, in 11 countries including, Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Investigators have also established a definite link between the contaminant and the severe reactions that have caused 81 deaths in the Unites States.

Heparin is made from the mucous membranes of the intestines of pigs and the process of rendering the ingredients takes place in Chinese family workshops which are for the most part, unregulated. The contaminant, oversulfated chondroitin sulfate is a cheaper substitute that was able to slip through the usual testing and was not identified until more sophisticated tests were utilized.

There has been speculation that the concentrated number of deaths in the US may be attributed to the practice of American doctors to use large, quickly infused doses of heparin. Additionally, the FDA may be better than its foreign counterparts at tracking serious side effects.

The FDA had reports as early as 2006 that some lots of heparin contained the cheaper additive, which begs the question…why did Baxter International wait until February 2008 to issue a recall?

Up next: The Heparin Debacle Part Two – Chinese Officials Play the Blame Game

Originally posted at InjuryBoard by Linda Snyder

Both Parties Agree – FDA Needs More Money

Linda Snyder — Wed, 16 Apr 2008 17:10:45 GMT

In a rare display of bipartisanship, both Republican and Democratic Senators agreed the Food and Drug Administration is under funded for next year. “To us, it’s clear that they’re seriously under funded,” said Senator Herb Kohl at the Appropriations subcommittee hearing on Tuesday. Kolh, a democrat from Wisconsin, is the head of the Appropriations subcommittee which oversees the FDA’s spending.

Senator Robert F. Bennett, Republican of Utah, the subcommittee’s ranking minority member agreed with Kohl and pressed Dr. Andrew C. von Eschenbach, the food and drug commissioner, to say how much more money the FDA needed. Dr. von Eschenbach replied he would “welcome an opportunity to present a scenario of portfolio options” for financing. He also expressed doubt that the FDA could accommodate the 20 percent budget resolution passed by the Senate last month. That’s an additional $375 million over the 2008 allocated budget which comes from taxpayer revenue as opposed to money that comes from user fees paid by drug and medical device companies.

Consider...

• A report by a panel of outside advisors released last year, asserts American lives were in danger because the FDA didn’t have the money, staff or the scientific expertise to protect them.

• Last month, Dr. von Eschenbach says the FDA “may fail in its mission to protect and promote the health of every American” and that “peril exists.”

• At the hearing on Tuesday, Dr. von Eschenbach reverses his stance and claims, “I believe we have been eminently successful up to this period of time.” He continues, “We are the world’s gold standard.”

• Dr. von Eschenbach testified at the hearing, in response to the heparin controversy, the contamination of heparin whose active ingredient which had been imported from China was “apparently, we suspect, done by virtue of economic fraud,” to enhance profit.

• After the hearing, Dr. von Eschenbach does an about face and says “he probably went too far” in his testimony. He claims the FDA does not have proof that the contamination was deliberate and fraudulent.

So, between a commissioner who flip-flops his position on an almost daily basis and an agency that is seemly run by the drug companies as the FDA approves drugs at the whim of drug companies as shown by the heparin debacle, the Vioxx tragedy, and Vytorin and Zetia half truths, we as consumers need to accept the fact the FDA as it exists today is not functioning in our best interests.

Originally posted at InjuryBoard by Linda Snyder

Vytorin and Zetia Only to be Used as Last Resort

Linda Snyder — Mon, 14 Apr 2008 18:52:32 GMT

The American College of Cardiology has recommended that the popular drugs Vytorin and Zetia should only be used after all other cholesterol lowering drugs fail. The panel's spokesman, Harlan Krumholz of Yale University, said: "Our strongest recommendation is that people need to go back to statins. … If you were put on this drug before you were fully treated on a statin, you should go back."

The panel based its findings on detailed evidence from a controversial study showing Vytorin worked no better than a statin drug currently being sold as a cheap generic.

Zetia was approved in 2002 and Vytorin in 2004 based on research showing that they dramatically reduce levels of LDL. High LDL levels can raise heart attack risk, however these drugs were not proven to actually save lives. Both Zetia and Vytorin are made up of a drug, ezetimibe, which blocks the absorption of bad cholesterol, LDL, in the gut. Vytorin also contains the cholesterol-lowering drug simvastatin. Statins work by blocking LDL synthesis in the liver.

The two-year trial, sponsored by the drugmakers Merck and Schering-Plough, involved 720 patients who had a severe form of inherited high cholesterol. Half were given simvastatin, also sold as Zocor, and a placebo. The rest were treated with the combo sold as Vytorin.

The drugs' performance was evaluated by measuring fatty deposits in the carotid arteries that supply the brain and femoral arteries in the legs. Researchers found no differences between patients who took simvastatin alone and those who took Vytorin.

"There is absolutely no difference … between the two treatment groups," said lead investigator John Kastelein of the Academic Medical Center in Amsterdam at the group's annual scientific session.

What makes this study particularly interesting is, in a second study published in the New England Journal, Krumholz and his co-workers scrutinzed prescribing practices in the US, where a $200-million-a-year consumer advertising campaign helped build Vytorin and Zetia into best-sellers. This marketing effort helped drug makers Merck and Schering-Plough gain a 15 percent market share for cholesterol lowing drugs in the US. In Canada, where direct-to-consumer advertising is banned, the market share was 3 percent.

Furthermore, earlier studies have shown that pharmaceutical companies spend almost twice as much on marketing a drug than they spend on research and development for that same product.

So, the question is…did the drug companies know about or suspect the effectiveness of Vytorin and Zetia before they put these drugs on the market, knowing they could make a large profit before the truth caught up with them? Did they choose to put profit over consumer safety by spending more money on the marketing campaigns instead of research and development?

Appropriately enough, shares of Merck (MRK) and Schering-Plough (SGP), the companies that market Vytorin, plunged this week to their lowest levels in years.

Originally posted at InjuryBoard by Linda Snyder

Top 10 Deadliest Drugs

Linda Snyder — Tue, 08 Apr 2008 16:31:29 GMT

In 1988, the AIDS activist group ACT UP staged a protest that led to a dramatic change in the US Food and Drug Adminstration (FDA) drug approval process. Previously, the drug approval process was slow, bureaucratic and unresponsive to patients who were desperately ill and might not live to see a drug approved. By 1995, the process became streamlined and dying patients with no other options were given early access to promising medications. Drugs that were granted “priority review” status saw the approval times drop from just under three years to as little as six months.

This makes perfects sense for terminal patients and for catastrophic diseases such as AIDS and cancer, however this streamlining process has allowed drugs to be approved before proper testing has been completed. Vioxx, which may have caused up to 100,000 heart attack and stroke related deaths, is a direct result of prioritizing speed over safety. And, studies have shown that drug makers are spending almost twice as much on marketing a drug than they are on research and development.

A dangerous by-product of this streamlined approval process is weaker standards. The arguments made for fatal diseases such as AIDS and cancer were then extrapolated to other less serious conditions. In 1999, Vioxx was approved under these diluted standards and only after millions of people have taken it was research made public showing that high doses of Vioxx increased the risk of heart attack by a factor of 5 compared to a similar painkiller, naproxen (Aleve).

So, what can you do to protect yourself? Be an informed consumer and research any drugs you are taking for any potential safety risks. Some drugs, like Darvon and Darvocet have been found to be no more effective than aspirin, and they may cause heart damage.

1. Oxycodone Prescription opiod painkiller 5548 deaths 1998 - 2005

2. Fentanyl Prescription opiod painkiller 3545 deaths 1998 - 2005

3. Clozapine Anitpsychotic 3277 deaths 1998 - 2005

4. Morphine Prescription opiod painkiller 1616 deaths 1998 - 2005

5. Acetaminophen Over-the-counter painkiller 1393 deaths 1998 - 2005

6. Methadone Prescription opiod painkiller 1258 deaths 1998 - 2005

7. Infliximab Immune-system modulating drug 1228 deaths 1998 - 2005

8. Interferon beta Immune-system modulating drug 1178 deaths 1998 - 2005

9. Risperidone Antipsychotic 1093 deaths 1998 - 2005

10. Etanercept Immune-system modulating drug 1034 deaths 1998 - 2005

Originally posted at InjuryBoard by Linda Snyder

Contaminated Heparin Syringes Recalled

Shannon Weidemann — Fri, 04 Apr 2008 10:23:34 GMT

A second manufacturer of pre-filled Heparin syringes has issued a drug recall for 32 lots of product. The syringes were manufactured by Covidien who received components for making Heparin from the same supplier as Baxter. Baxter has recalled all of the Heparin they manufactured due to contamination with a substance that mimics Heparin.

The Mansfield, Mass., company issued the recall in response to a notification from Scientific Protein Laboratories (SPL), which is the company that supplies Covidien with the active pharmaceutical ingredient used to make heparin.

Covidien, which was formerly known as Tyco Healthcare, said there have been no reports of adverse events associated with its heparin products.

SPL is also the supplier to Baxter Healthcare, whose heparin products have been linked to serious allergic reactions and at least 19 deaths.

Some of the drug components were manufactured by a factory in China. The U.S. FDA and China's similar branch are both investigating the matter. Heparin has been recalled in Europe and Japan as well.

Originally posted at InjuryBoard by Shannon Weidemann

Pharmaceutical Companies Spend Twice as Much on Marketing than on Research and Development

Linda Snyder — Tue, 11 Mar 2008 19:42:10 GMT

PLOS Medicine, an online medical journal conducted a study using numbers from 2004 and concluded that pharmaceutical companies spent almost twice as much on marketing than on their research and development for their United States markets.

As a marketing person, on the one hand I am in awe of these marketing budgets, in excess of $57.5 billion dollars. But as a consumer, I'm a bit dismayed that the figures for research and development come in at just over half that amount at $31.5 billion dollars.

If anyone still believes that the pharmaceutical companies are in business for the good of mankind, let's review those numbers again. $57.5 billions dollars on marketing and $31.5 dollars on research and development. Not that there's anything wrong with that. Pharmaceutical companies are for profit businesses and are in business to make money.

But, let's consider those numbers in light of the recent Heparin recall. What if Baxter had spent more money on research and development? Could more extensive research and development have prevented the estimated 20 plus deaths and 700 plus adverse reactions? Common sense says yes.

The other disturbing trend in the marketing of drugs is now the pharmaceutical companies are marketing directly to consumers. Again, nothing wrong with that. Except we're usually talking about medications that most people need. It's not an optional luxury item for most people; they need this medication to survive. And in the case of medications, the consumer is usually not educated enough to determine if that particular medication is right for them or not. But, they saw it on television and we all know that every advertisement you see on TV is truthful.

Ultimately, it's the consumer is who is paying for that $57.5 marketing budget. I don't know about you, but I rather pay for more research and development.

Originally posted at InjuryBoard by Linda Snyder