Why Drug Companies Oppose “Free To Choose” Medicine

Thirty-one states have passed “Right To Try” legislation that, in theory, makes it easier for patients with terminal diagnoses to use drugs that are in the investigational stage but haven’t yet been approved by the FDA. I use the phrase “in theory” because state legislation doesn’t mean much in the field of drug regulation: it’s all determined by the federal government, which has the power to shut down unapproved uses of medications, even if the state government says otherwise.

 

The idea behind “Right To Try” state legislation is compelling: from a common-sense perspective, there aren’t many good reasons why terminally ill patients should not be allowed to “try” medicines their doctor believes might help them, even if the medicine isn’t yet approved. After all, many of the approved medicines for terminally ill conditions aren’t that useful. For example, most pharmaceutical cancer treatments have been approved on the basis of “surrogate markers” (like reduced tumor growth rates) instead of being actually shown to improve mortality.

 

But “Right To Try” has a couple problems with it. To me, the biggest problem is that doctors end up prescribing medication blindly. Consider Siddhartha Mukherjee’s recent article, “The Improvisational Oncologist,” in which Mukherjee describes choosing the medication he prescribed for a woman with myelodysplastic syndrome by testing the patient’s bone marrow against three-hundred different medications at three different doses each. The context of Mukherjee’s article suggests those were all approved medications. When it comes to medications that aren’t yet approved, the situation is even worse: the drug companies typically keep the vast majority of scientific data on drugs confidential. The doctor is thus blindly hoping that the drug they prescribe will have an effect, and they’re blindly hoping that the drug won’t also come with serious side effects that might leave the patient even worse off.

 

A new proposal to help many of the same patients, called “Free To Choose Medicine,” has been getting a big push from economists such as by Alex Tabarrok and Bartley Madden. “Free To Choose Medicine” would set up a completely separate track whereby patients can access drugs that have made it to “stage II” clinical trials, and it wouldn’t be limited to terminally ill patients. The biggest difference from the “Right to Try” legislative scheme, however, is that this access would be tied to public access into data about how well the drugs are working. As Madden explains:

 

FTCM legislation would provide for government oversight of an open-access, Internet-accessible database. It provides up-to-date information for patients and doctors about a FTCM’s drug’s potential benefits and risks before they choose to use it. This is a self-adjusting system wherein more patients use FTCM drugs that work well and vice versa.

The open-access database would contain treatment results of FTCM patients including their genetic makeup and relevant biomarkers. This database (not part of Right To Try legislation) would reveal subpopulations of patients who do extremely well or poorly with the new drug. Pinpointing such groups of patients is a huge benefit to, not only patients, but to biopharmaceutical researchers working on new breakthroughs in medicine.

 

Such a database could be immensely useful, so long as it is built properly and so long as it is provided with enough information. To me, that means two essential components.

 

First, the database would have to be mandatory. The FDA already has an “Adverse Event Reporting System,” which tracks side effects from approved drugs, but it is by no means perfect. The biggest problem is that it’s entirely voluntary; consequently, only a small fraction of doctors, hospitals, and patients actually submit reports to it. The “Free To Choose Medicine” track would be an even smaller number of patients and so, to have a viable database, reporting to it would have to be mandatory. This isn’t as difficult as it sounds: require the prescribing physician to regularly submit reports of all patients in the process, and compensate them for their time in doing it. Such a mandatory database would also be far more useful than the existing database, because it would allow researchers to draw more firm conclusions about a causal link between the medicine and side effects (as well as the medication’s efficacy). Moreover, it would prevent drug companies from hiding side effects — in Japan, for example, drug companies are regularly cited for failing to properly report side effects.

 

Second, the database would have to include easy access to literature about the drugs, including internal literature generated by the drug companies. We want doctors and patients to be able to make informed decisions about these unapproved drugs, but we can’t expect them to all become experts in pharmacovigilance (the science of reviewing adverse event database) nor can we expect them to spend hours on Google Scholar looking for recent literature on the drugs. The websites need to be able to point doctors directly to the medical literature, and the drug companies need to be responsible for keeping those databases up-to-date and for including their own literature. If, for example, a drug company does a study in primates that shows the drug has a high risk of a certain side effect, that information should be made available immediately to any doctor prescribing the drug and any patient using it. If, for another example, a drug company does a study in transgenic mice that shows the drug isn’t effective, that, too, should be made available immediately. Anything less would create a situation in which doctors are prescribing, and patients are using, unapproved drugs with less than full scientific information about the drugs, the exact situation that “Free To Choose Medicine” is trying to avoid.

 

And that’s the big catch: I highly doubt the big pharmaceutical companies would ever allow that kind of access into their internal data. The big drug companies don’t want doctors or patients to know the real scientific data about their drugs. Rather, they want them to have a narrow slice of it, just the good parts. But if we’re going to start giving patients access to unapproved medications, true transparency is the only way we can prevent drug companies from exploiting the process by dumping unsafe and untested medications on the public.

Why Drug Companies Oppose “Free To Choose” Medicine syndicated from http://helloinjuryhelpnowposts.tumblr.com

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