It’s enough to make your blood boil.
Last week it was revealed that the US Food and Drug Administration (FDA) admitted that it bowed to political influence when it approved a medical device its own scientists had deemed repeatedly as affording little benefit to the patient.
The name, or indication of the device matters little. Neither does the identity of the manufacturer involved, or the four members of Congress who applied what was described as relentless pressure (read lobbying) to get a product approved. Who they are doesn’t matter.
What matters are the process, and the loss of principle.
In a nutshell, a device that was deemed unsafe by FDA scientists because it often failed was approved anyway by the agency. Behind the approval was the relentless lobbying of a handful of Congressmen who represented the state where the manufacturer involved calls home. The Congressmen involved also, according to a September 24th report in the New York Times (NYT), received political contributions from the executives of the manufacturer involved.
The intense lobbying began a few months after those contributions were made. It would not be long before the FDA Commissioner, who stepped down this past January, became personally involved in the issue. The NYT reported the position of one FDA manager who had concluded that the FDA Commissioner “was demanding not only an expedited process but also an outcome in favor of” the manufacturer.
There is no argument that the medical device and drug industry is often a license to print money. The health care field has become big business.
However when did that become the role of the FDA? It’s the federal agency that serves as the watchdog over our health care system. It’s the agency that is charged with the granting of approval for new drugs and medical devices. It’s the monitoring entity that is supposed to ensure that a drug, or medical device delivers the goods and does what it says it does.
Rid the market of unsafe drugs, slap the wrists of the manufacturing offenders who try to pull the wool over our eyes in the name of greed, and make sure that what DOES show up on pharmacy shelves, or ultimately placed in our own bodies, is the best and safest available.
And nobody’s interest, opinion or position can supersede a process based on safety and efficacy.
That’s the perception, isn’t it? That’s what America believes. If a tub of meat is stamped USDA choice, it MUST be good. If a drug is stamped FDA approved, we can put our fears to rest.
Thursday’s revelation is exactly why we can’t.
First the FDA is understaffed and underfunded—even though, it has been reported, part of its funding comes from the industry it serves. That’s a problem in itself. If there was ever a blatant conflict of interest, it is thus.
The FDA has been slow to react to drugs that have proven to be dangerous. Trasylol is an example. In spite of mounting evidence the ‘people’s health watchdog’ appeared to drag its heels in the face of mounting evidence that the drug was dangerous.
And the FDA doesn’t appear to have the mandate to order a dangerous drug off the market. All it can do is lobby the manufacturer to take action.
The true power of the FDA, it appears, is in the approval process—and even then there is plenty of opportunity for things to slip through the cracks. According to a rule that’s been around since 1972 any medical device that is deemed substantially similar to something that is already on the market can enjoy an approval process that is fast-tracked. The thinking has been, if a new device is substantially similar to something that has already been tested and approved, and is performing well on the market, then why go through an elongated testing and approval process all over again?
Supporters of that position may have a point. However a succession of medical devices that are ‘substantially similar’ to the most recent device on the market probably bears little resemblance to the first product, way back there, that went through rigorous testing. Thus, those testing safeguards become diluted over time.
And there is no guarantee that a drug—any drug—is completely safe. Safety is not even the criteria. The criteria, in reality: is the drug effective for the purpose and for the indications to which it was designed? And does the benefit outweigh the risk?
In the end, the FDA has the final say on whether a drug, or a medical device gets the nod to go to market. For that job the agency employs a stable of scientists and engineers whose job it is to vet, without influence, a new product. The stakes are always high. The manufacturer could stand to make millions, if not billions from a new drug. What if it is turned down?
Some drugs and medical devices ARE rejected. However Thursday’s revelation points to a troubling aberration. A medical device was approved in spite of the best opinions of its own scientists, in the face of intense lobbying by four members of Congress who represent the American state housing the manufacturer, (members who accepted political contributions from individuals representing that manufacturer) and as the result of influence of a commissioner who overruled his own scientists and experts.
Would you go to a doctor if he had a drug company in his back pocket? No. Would you dare walk into a hospital that subscribed to looking after you according to what was best for the business, rather than what’s best for you?
Of course not.
If there is anything good to say on this issue, it’s that it even came out at all. That’s a good sign. There has to be some degree of transparency in government entities and this is healthy. What will come of it is another matter. Health care in this country, in some fashion, is going to be reformed. Obama will see to that. How far will it go and what it will look like is the bigger question. Negotiation and compromise is key. That’s just how Congress works.
But compromise, negotiation and influence simply does not have a place in the agency charged with watching over the drugs we take and the medical devices that get implanted into our bodies.
Thursday’s revelation is ample proof that the FDA needs to be re-designed from the ground up. Funding needs to come from government, not the industry. The FDA should also be shielded from lobbying. Give the FDA a sharper mandate. When the majority of learned doctors, scientists and engineers in its employ conclude that the risks of a product outweigh the benefits, upper management cannot have power to veto that majority decision.
And once a product is out there, on the market the FDA needs to be much more than simply ticket-writers. Give the agency the authority of the police. It should have the mandate to lay charges, and pull a dangerous product off the market regardless of the opinions of the manufacturer, which is biased anyway.
The FDA should be above undue influence, lobbying, and special interests. It should be 100 percent taxpayer funded. It should have the power to approve and remove as needed.
Ultimately, the FDA needs to become what most Americans perceive it as: the drug police. Only the FDA is not the police. Its mandate appears to allow manufacturers to do what they want. Beg forgiveness, rather than seek permission—then laugh all the way to the bank. Until changes are made, the kids will be allowed to roam free in the candy store without a parent in sight….