Riding The Wave – Multiple Myeloma

“Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves?”

There was a bit of a dust up when this article came out in the January Issue of Vanity Fair, “Deadly Medicine“. I learned of it from a regular poster on Beth’s Myeloma ListServ. I went over to the story and got depressed. I couldn’t even finish reading it. I sent it to a couple of Myeloma folks I respect and got two interesting viewpoints and calmed down. I meant to take a stab at writing a little more about it, but first, I had to be able to get through the article.

As I have mentioned before, the media are Chaos Merchants. I have to realize that going in. As I do that, I’m struck by the title of the story, opening salvo (above), and then this very powerful piece of graphics that you hit right away in the story. So before you even get into any details and hopefully some FACTS, you may be predisposed to the view of the authors vs. the view of the facts. Maybe that’s why I got depressed and stopped reading. Secretly all the little skulls in the capsule did it. Subliminal messages… But then, maybe I will agree with the authors completely after examining his presentation and FACTS. Who knows… A strong cup of coffee first, and then plow on ahead. (I will tell you the story fell pretty flat overall in the fact that it got little to no MSM coverage.)

Caption Read "Take Two Aspirin"

Article: “They have gone there to find people willing to undergo clinical trials for new drugs, and thereby help persuade the U.S. Food and Drug Administration to declare the drugs safe and effective for Americans.”

Really? “persuade the FDA?” Can you really persuade the FDA? Is that how it works? I would expect that like the FDA or not, they have a standard that Pharmas adhere to whether its overseas testing or testing on legal American Citizens. I agree that the FDA has a whole host of issues I object to, one is their authorizing members who approve such drugs, having all manner of conflicts of interest. But is testing on nonAmericans the problem or FDA process and enforcement?

Article: “Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do.”

Really? Human bodies that are nonAmerican metabolize drugs differently?

Article: “It’s also easier to recruit patients, who often believe they are being treated for a disease rather than, as may be the case, just getting a placebo as part of an experiment.”

Really? How is this different than trials in the US? (see TMB Opinion Article by Dr. Jim Omel)

Article: “Regulations in many foreign countries are also less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent.”

This is definitely a human right’s concern, but clearly makes the running of trials significantly less risky and costly for the Pharmas. While I like to think people have high moral/ethical standards, and generally I believe to my core they do, we tend to conjure up the Enron/Madoff’s of our society. While it is up to the regulations of the country, the fact that you can, doesn’t mean you should.

While the article goes on to cite criminal researchers conducting trials in other countries and then the FDA failing in it’s duties to accept warnings about subsequently approved drugs, I was thinking, well, we have that here too. How is this different because it is being run on nonAmericans or not on European soil? I submit to you there is no difference, though admittedly there may be more opportunity, as the article goes on, about subcontracting clinical trials to for-profit, US Companies. So what is the problem really? I suggest to you it is FDA (American) and Pharma (American) problem. The more removed you get from the company’s mission and powers at be, the easier it is to have “plausible deniability.” But is this an overseas outsourcing problem? No, its a government/corporation problem.

Article: “The F.D.A. gets its information on foreign trials almost entirely from the companies themselves. It conducts little or no independent research. The investigators contracted by the pharmaceutical companies to manage clinical trials are left pretty much on their own. In 2008 the F.D.A. inspected just 1.9 percent of trial sites inside the United States to ensure that they were complying with basic standards.”

Well that is definitely not an overseas outsourcing problem, but an FDA problem.

The article goes on to talk about death tolls and the Justice Dept’s investigation of one drug company under the “Foreign Corrupt Practices Act”. But so far, the article, while concentrating on the outsourcing of clinical trials really shines the light on American pitfalls within the FDA, which like our States, gets unfunded mandates by Congress that it has no manpower to enforce adequately.

Article: “The only people who seem to care about the surge of clinical trials in foreign countries are the medical ethicists—not historically a powerhouse when it comes to battling the drug companies. A team of physician-researchers from Duke University, writing last year in the New England Journal of Medicine…”

The NEJM linked article WAS NOT provided in the online version of Vanity Fair’s article, nor even its title for reference. Tisk, tisk.

Article: “And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.”

Emm, I agree that because its clearly cheaper and easier to get participants to run trials overseas, the shear volume of clinical trials that can now be run, will produce MORE of everything. MORE drugs that might save lives (as we Myeloma folks are very interested in) and MORE unethical practices with less oversight just due to the geographical proximity. If FDA investigators can’t seem to get to Atlanta to look over a trial on site, imagine the difficulty of getting over to India!

Bottom line I came away with a couple of things. One, cheaper trials means more potential life saving drugs potentially getting to market. But as one friend, not being of the more conventional medical path, aptly points out, that for us Myeloma folks, this raises some very sensitive issues. Indeed it does.

My second friend pointed out that we have these same issues in American trials, as I have pointed out in my assessment of the article as well. That while the FDA has its problems, it does indeed turn down approval requests and pull drugs off market. In addition, he pointed out to me that drugs are denied by FDA because overseas trials were not adequate in their data. So while imperfect, it is doing its job. But imagine, without increased federal funding up against increased investigative responsibilities and now increased clinical trials abroad, we are in need of some serious efforts to beef up FDA’s ability with real manpower to do the job it has be asked to do.

Secondly, we definitely don’t want our life saving drugs on the backs of dead poor people/children in foreign lands. That price, for me, as a caregiver, who loves my husband dearly is indeed too high. But I would feel that way if they were American people/children too.

As Myeloma folks, hanging on every breath of the latest research finding, we want our new drugs fast tracked through FDA, what MMRF does. But are we prepared to deal with the potential problems? (i.e., Revlimid Scare). Are we willing to take that risk? Some are and some are not.

Your thoughts?

Personally, I hate drugs. Well let me say really, I hate that so many of us are on so many of them! I have spent most of my adult life staying off of them. I have a small medicine cabinet full of a few first-aide things. If someone needs an Advil I usually have to call a neighbor (but I have Aspirin?). That is until Dave got sick. Then I needed an entire carry-on suitcase to transport his drugs back and forth from Arkansas. It is a Love/Hate relationship. Drugs can, and do, help to save lives. But relying on them as a primary source of relief for every little thing, is something I still steer clear of. I will use them though, I’m not a puritan – after a recent dental surgery, where I passed on the knock-me-out sedation – “Yeah man, give me my Percocet!”

Tags: Deadly Medicine, Outsourcing drug research, postaweek2011, Vanity Fair January 2011