Denver Personal Injury Lawyer - FDA & Prescription Drugs

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

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

Fentanyl Patches Made by Actavis Recalled

Jenny Albano — Tue, 19 Feb 2008 00:11:54 GMT

Actavis Inc., in conjunction with the FDA, is recalling 14 lots of its Fentanyl transdermal system CII patches because the patches have a defect that can cause them to leak. The Fentanyl patches were available from wholesalers and pharmacies throughout the United States. Fentanyl patches sold in Europe are not affected by this recall.

The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used.

Being exposed to fentanyl gel can lead to serious side effects, such as respiratory depression, and can result in an overdose and can be fatal. If you, or someone you know comes into contact with this gel, immediately wash the exposed area with water (not soap) and flush the defected patch and any patch that has come into contact with it down the toilet.

Here are the lots being recalled:
27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:
Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

If you have any fentanyl patches by Abrika or Actavis make sure to check the recalled lots.

Originally posted at InjuryBoard by Jenny Albano

Medication Abuse a Problem Among Young Adults

Linda Snyder — Mon, 14 Jan 2008 11:12:53 GMT

A staggering new report released by the Substance Abuse and Mental Health Services Administration stated that 3.1 million Americans ages 12 to 25 have used an over-the-counter cough and cold medicine in order get high.

Cough syrups and cold pills are being used in large doses to get high and induce hallucinations for young people. The 2006 survey was completed with 45,000 people ages 12 to 25 being interviewed. The report also showed that 1 million of young adults are at highest risk of such abuse of medication.

Overall, the level of abuse of these drugs is comparable to levels of LSD, methamphetamine or the drug ecstasy.

The medications most commonly being abused are NyQuil, a Coricidin product, and Robitussin.

As of December 2005, Congress renewed the USA Patriot Act to include the restrictions on sales of medications containing pseudoephedrine which can be used to make methamphetamine. As a result, stores are required to lock up cold medicines such as Sudafed as well as asking consumer to provide a signature and driver's license, limited to purchasing such medication to one box a day and three per month.

The Drug Enforcement Administration took these first steps in order to help prevent the ongoing abuse of over-the-counter drugs.

For more information on this subject, please refer to the section on FDA & Prescription Drugs.

Originally posted at InjuryBoard by Linda Snyder

Merck Takes Responsibility For Vioxx Through $4.85 Billion Settlement(2)

Linda Snyder — Wed, 14 Nov 2007 12:17:26 GMT

It's been since 2004 that Merck & Co., one of the largest pharmaceutical companies in the world, has taken the pain medication Vioxx off of the shelves. Finally, on November 9th, Merck settled the numerous Vioxx lawsuits with agreeing to pay $4.85 billion.

It appears that the Vioxx manufacturer finally recognized, after obtaining mixed results in the early Vioxx cases it forced to trial, that a better approach is to accept responsibility for the injuries and deaths caused by it's product through settlement.

There were 27,000 lawsuits against Merck, claiming that either they or family members suffered injuries or death as a result of taking Vioxx. Merck claimed that the dangerous effects of Vioxx only caused harm after 18 months of use; independent scientists and plaintiff lawyers have since then proved those claims wrong.

The new settlement could still fall through, however with many top U.S. lawyers agreeing to the deal, plaintiffs who choose to not accept will face difficulty in pursuing their own claims.

Past reports of how much Merck would have to settle for ranged from $10 billion to $20 billion. The $4.85 billion settlement is still one of the largest settlements in this industry.

Civil and criminal investigations do continue against Merck from numerous states.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.

Originally posted at InjuryBoard by Linda Snyder

Counterfeit Drug Sales through the Internet a Growing Problem

Courtney Mills — Wed, 05 Sep 2007 14:49:13 GMT

Last month a federal grand jury indicted 18 people on charges stemming from fraud to racketeering over their participation in an international online pharmaceutical sales ring. The company's name was Affpower, and by the time the federal government had shut the sales operation down, Affpower had moved over $126 million in illegally prescribed pharmaceuticals.

The arrests haven't managed to stem the flow of illegal pharmaceuticals from pushers online because of the internet's versatility. Essentially, these online operations are pharmacies with a few doctors signing off on health questionnaires that people have filled out over the internet as to their condition and need for medication.

Online buyers ostensibly pay for prescription drugs at a much higher rate than they would in a conventional pharmacy because no traditional doctor visit is required. In truth, the real reason that pharmaceuticals are so expensive online is because of the added advantage to some buyers, namely addicts, of skirting regulatory agencies.

Online buyers also run the risk of purchasing counterfeit drugs because of the lack of regulatory agencies' oversight. According to a Reuters article today, this has lead to a woman's death after a counterfeit treatment for anemia, deaths in Cambodia because of counterfeit malaria drugs, and children in Haiti and India killed by acetaminophen made with antifreeze.

Policing these unregulated online pharmacies proves very difficult for the FDA, which is already strapped for funds and spread very thin.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Courtney Mills

Avandia Heart Attack Link Known Long Ago?

April Armani — Wed, 23 May 2007 12:59:21 GMT

According to consumer advocacy group Public Citizen, the FDA knew about the link between the Diabetes drug Avandia and heart attacks as long as five years ago.

In 2002, U.S. Food and Drug Administration staff scientists called for reports of congestive heart failure to be included on the label of Avandia as well as Actos, made by Takeda Pharmaceutical Co. Ltd., the group said, citing an internal FDA document.
The group released the memo one day after researchers reported Avandia, or rosiglitazone, raises the risk of cardiovascular-related death by 64 percent and the risk of heart attack by 43 percent.

If you or a family member has suffered a heart attack or other severe side effects as a result of taking Avandia, it may be important to protect your legal rights and contact an attorney.

Originally posted at InjuryBoard by April Armani

Pharmaceutical Company Punished for Pushing Addiction

April Armani — Thu, 10 May 2007 16:39:52 GMT

OxyContin is an incredibly addicting painkiller. Until today, however, few realized that the pharmaceutical company which manufactures the drug actually promoted an OxyContin addiction. Roughly 6.3 million Americans report that they're currently using prescription drugs for nonmedical reasons, according to the U.S. Department of Health and Human Services.

Prescription drug abuse knows no age. The elderly are vulnerable because they're more likely to take many medications, often long term. Also, women may be as much as 55% more likely as men to be prescribed drugs that can be abused, such as narcotics and tranquilizers; therefore, their risk is greater, according to the NIDA. For more information about painkiller addiction, click here. But now there is relief for the addicted and misled.

The maker of OxyContin and three of its current and former executives have pled guilty to misleading the public about the drug's high risk of addiction.

U.S. Attorney John Brownlee stated in a news release today that the pharmaceutical company and its executives will pay $634.5 million in fines. The plea comes just two days after the company agreed to pay $19.5 million to 26 states and D.C. to settle complaints that it encouraged physicians to over prescribe OxyContin. "With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice." To read more, click here.

Originally posted at InjuryBoard by April Armani

Ortho Evra Heat Precautions

Staff Writer — Tue, 16 Jan 2007 18:20:39 GMT

It was already know that Ortho Evra can cause blood clots. Now the maker of the patch is saying that overweight women using the patch are at a particularly high risk of developing blood clots. Janssen-Ortho Inc. (subsidiary of Johnson & Johnson) also warns that women should not expose the Ortho Evra patch to sources of heat such as saunas and whirlpools. The company believes there is a theoretical risk that doing so might cause an unintentional increase in estrogen exposure.

Janssen-Ortho Inc. is a Canadian manufacturer who markets Ortho Evra in the United States. These new warnings were endorsed by Health Canada, the Canadian agency responsible for ensuring the safety and effectiveness of pharmaceutical products in that country. No such precautions exist in the United States concerning heat exposure to the patch.

http://www.creative-weblogging.com/search.php?network=1&keyword=ortho+evra&blog_id=46§ion_id=10

Originally posted at InjuryBoard by Staff Writer