Drugs/Medical Archive

A Muted Win For Avandia Manufacturer—But Stay Tuned…

July 15th, 2010. By Hunter West

So Avandia has been stayed from execution—for now—by virtue of a majority vote by an expert panel of experts brought together by the US Food and Drug Administration (FDA) that debated the drug’s safety and efficacy for two days this week. The Type 2 diabetes drug that has been under much fire for the past couple of years was further challenged by the long-awaited gathering which ended with a vote to leave Avandia, manufactured by GlaxoSmithKline (Glaxo), on the market for the time being.

But the victory for Glaxo is muted.

While the panel voted 20-12 to leave Avandia on the market, it will not likely be left alone. That’s because at least half of those voting ‘yay,’ according to the July 14^th edition of the Wall Street Journal (WSJ), tied their vote of support to increased restrictions on a drug that has already faced significant reduction of sales since 2007. Supporters of the drug who voted to keep Avandia on the market indicated after the vote that they only did so due to the lack, they said, of hard evidence with regard to potential harm.

They also said Avandia should be used only as a drug of last resort.

That’s good news for rival Actos, manufactured by Takeda Pharmaceuticals. Even though both Avandia and Actos carry black box warnings for fluid retention and the ensuing risk for heart failure, Avandia is thought to carry a greater risk for heart attack than its rival.

So much so, in fact, that the FDA directed the advisory panel to put that matter to a vote, pitting Read the rest of this entry »

Tags: Actos, Avandia, FDA, TIDE
Posted in Drugs/Medical, Emerging Issues | No Comments »

Point of Byetta Study? Warning is Still Needed

July 13th, 2010. By AbiK

Despite a recent study that puts into question the link between Byetta and pancreatitis, I was looking back over Byetta’s history as it relates to FDA labelling. For some background, Byetta came on the market in 2005—to treat patients with type-2 diabetes—and some reports indicate that over 10 million Byetta prescriptions have been written since 2005.

But since 2005, there have been some other interesting (or should I say “disturbing”) developments with Byetta as well. According to the FDA, between April 28, 2005 and December 31, 2006, there were 30 domestic reports of acute pancreatitis in patients who were taking exenatide (the generic name for Byetta). Clearly feeling that thirty such cases within the span of just under two years was perhaps worth raising an eyebrow, the FDA responded with some additional Byetta warnings. Here’s what happened:

October, 2007: the FDA mandated that Amylin and Eli Lilly include stricter, more prominent warning labels about possible Byetta side effects on Byetta’s packaging; the new Byetta warnings included acute pancreatitis.

August, 2008: the FDA issued an alert to healthcare providers regarding six additional cases of necrotizing or hemorrhagic pancreatitis among Byetta patients. Two of those six cases resulted in death.

November, 2009: Between April, 2005 and October, 2008, the FDA had received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Based on this, the FDA issued new safety information on Byetta to include a warning of possible kidney function problems a a side effect.

Now, while I surely don’t believe the FDA is incapable of error or misjudgement (we only have to look to Avandia this week to question such), it does seem that when the number of reports Read the rest of this entry »

Tags: Byetta, FDA, Kidney Function, Medco, Pancreatitis
Posted in Drugs/Medical | 4 Comments »

80% of Approved US Drug Trials Done Outside US – What?!?

July 1st, 2010. By Hunter West

 

“As sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained.”

– Daniel R. Levinson

A recent report by the inspector general of the Department of Health and Human Services reveals just how much pharmaceutical drug testing is going on in the shadow of foreign shores… 

Eighty percent, according to Daniel R. Levinson. That’s 80 percent for trials of all drugs approved for sale in the US by the Food and Drug Administration (FDA) in 2008. 

Wow. 

What’s more, 78 percent of all subjects who participated in clinical trials were enrolled in foreign sites for drugs given the nod that year. 

For some time now, there has been concern about the quality of drugs manufactured offshore. China comes to mind. Look at the heparin debacle of a few years ago. While there is massive incentive for drug companies to manufacture on foreign soil for the cost savings (and the better bottom line that goes along with it), the downside is that often you don’t know what you’re getting. 

And now, the revelation that most drug testing is going on somewhere else. 

That’s troubling, because in both cases—manufacturing and testing—the FDA lacks both the financial and staff resources to properly monitor things. 

Check out some of the numbers contained in Levinson’s report, released towards the end of June and summarized in The New York Times. The FDA inspected fewer foreign clinical trial sites, than Read the rest of this entry »

Tags: Clinical Trials, Drug Approvals, FDA
Posted in Drugs/Medical | No Comments »

Avandia Study Conflicts – and Conflicts of Interest?

June 30th, 2010. By AbiK

So after the latest two Avandia studies came out earlier this week, we then see a third Avandia study—this one will also be debating fodder for the advisory panels at the FDA’s July meeting—the one that will determine Avandia‘s fate. The study was presented late Monday at the American Diabetes Association’s annual meeting by Dr. Richard Bach, associate professor of medicine at Washington University School of Medicine in St. Louis.

Here’s the thing though—the fist two studies basically added a few nails in Avandia’s ever-growing coffin. But this latest study to hit the airwaves actually digresses from the previous two in its findings—it states that there is no increased risk of heart attack, stroke or death associated with taking Avandia.

Hmm. Doesn’t that just make things a little…less definitive?

However, upon looking more deeply into this third study, some things about it just sort of pop out. For example, according to an article from healthfinder.gov, this third study if of a smaller sample size: 2,400 patients—compared to over 35,000 from the study done at the Cleveland Clinic.

There’s more..

• The third study was funded by the National Institutes of Health (NIH). Oh, and GlaxoSmithKline (GSK). Oh, and if you recall, GSK just happens to make Avandia. Conflict of interest? (just asking).
• While death, heart attack and stroke incidence rates were apparently 28 percent lower in the third study for those taking Avandia vs. those not taking a thiazolidinedione (TZD) medication, congestive heart failure was higher—just not at a rate “considered significant”. What was significant was a 45 percent increase in risk of fractures for those who took Avandia. (Ok—not heart-related, but 45 percent sounds more than significant to me).
• Apparently the ages of the participants in the third study were lower than that of the other studies. Translation: the other studies’ participants may have been more frail. Two things here: first, I don’t care what ages folks are who are affected by a drug–everyone’s well-being matters. So if an older population is more adversely affected, they’re still adversely affected. And second, so the tests are not comparing apples to apples–which should detract from the ability to make comparisons and draw conclusions.

Hard to say where the FDA advisory panel will net out in July. Will we still see Avandia on the market? Stay tuned.

Tags: Avandia, Glaxo, GlaxoSmithKline, GSK
Posted in Drugs/Medical | No Comments »

Zimmer and Surgeon Split Ways–FDA in the Middle?

June 22nd, 2010. By janem

Zimmer Holdings, the manufacturer of medical devices, has cut loose its long-time consultant, Dr. Richard A. Berger, after his reports that Zimmer’s mechanical knee replacement is prone to failure. He could’ve been a whistleblower. Instead he complained to Zimmer and his next year’s contract has not been renewed.

I wonder what would have happened if he first complained to the federal government and the FDA—which is typically the first action to take if a whistleblower plans to file a qui tam lawsuit ( claims against pharmaceutical companies are becoming almost commonplace). Second, you find a good attorney.

Getting back to the good doctor. It’s not like he needed the money: according to the New York Times, Zimmer portrayed Dr. Berger as a master surgeon and paid him more than $8 million over a decade. On his website, Dr. Berger freely admits that he “receives royalties and payments from the manufacturers of these devices”.

But in 2005, Dr. Berger implanted Zimmer’s NexGen CR-Flex device in about 125 patients and within about a year, x-rays showed that the device was loose and had not fused completely. Patients were in pain, apparently because of the loose joint. Dr. Berger did his due diligence and reported the problems to the maker.

Here’s the crunch: the FDA never required Zimmer to study the device in patients before selling it. Zimmer dismissed the doctor, saying it was his technique to blame and not a manufacturing defect. Dr. Berger told the Times that other surgeons were soon reporting similar problems.

In the Times article, experts cited that the falling out between Dr. Berger and Zimmer highlights the lack of independent, unbiased information about orthopedic implants, since there is no system of tracking the performance of artificial hips and knees in the US.

Whisteblowers have file qui tam lawsuits against several medical device companies, alleging improper marketing when the products were sold off-label, which resulted in Medicare paying excessive reimbursements. If successful, these suits can reimburse the government big time. But what would happen if a whistleblower came forward in the case of the Zimmer knee replacement, when the FDA didn’t require any controls, nor clinical trials? It would seem that someone should blow the whistle on the FDA…

Tags: Dr. Berger, knee replacement, Medical Device, Zimmer
Posted in Defective Products, Drugs/Medical | 5 Comments »