'Cures' bill raises safety concerns for experts 6/7/15 Washington Examiner

[*GG*]

Medical devices and drugs could reach your hands faster if a massive House bill is approved, but leading experts question whether they will be safe.

Two medical experts are concerned several provisions in the bipartisan 21st Century Cures Act may unnecessarily speed up product approvals at the expense of thorough reviews for safety and effectiveness.

"Changing the Food and Drug Administration's standards to get more drugs on the market is inherently risky to patients," Dr. Aaron S. Kesselheim, associate professor of medicine with Harvard Medical School, told the Washington Examiner.

Kesselheim, with Harvard professor Dr. Jerome Avorn, wrote an editorial in the New England Journal of Medicine that criticizes parts of the measure.

The bill was unanimously approved by the House Energy and Commerce Committee last month and awaits a vote from the full chamber. That vote could happen as early as next month, Committee Chairman Rep. Fred Upton, R-Mich., and Rep. Diana DeGette, D-Colo., told the Examiner.

cont'd

http://www.washingtonexaminer.com/cures-bill-raises-safety-concerns-for-experts/article/2565734

 

[Snow Leopard]

What does this actually mean?

Is it pharma money grab or something else?

 

[*GG*]

Since it is being brought to us by the US gov't, probably not much for the money spent! LOL

Like Pharma wants to CURE disease, then they would have fewer customers!

I think only time will tell, some of the implications is probably letting dying patients try drugs that are in the pipeline. Seems reasonable to me!

GG

 

[sarah darwins]

Well, that's confusing. From the article:

More than two-thirds of new drugs are approved based on data from trials that last six months or less, according to the opinion piece, which cited a separate study of clinical trial data from 2005-12.

In addition, a third of new drugs are approved on the basis of a single trial, the average size of which is about 760 patients, the authors wrote [Kesselheim and Avorn in a New England Journal of Medicine editorial].

"Once the FDA starts its review, it approves new medications about as quickly as any regulatory agency in the world, evaluating nearly all new drug applications within six to 10 months," the article reads.

That evidence juxtaposes a study from Tufts University that found it costs more than $2 billion and takes a decade to get a drug to market.

I had always understood something like the later to be the case — ie. it takes many years and vast sums of money to get a new drug to market. If Kesselheim and Avorn are correct, the drug companies may have been fibbing just a teeny bit. Who knew?

It would be nice to get the truth of this.

 

[barbc56]

@sarah darwins

I could be wrong but I think the approval times are after all the years of studies, ect.

 

[WillowJ]

The authors were pleased, however, that the House gives the National Institutes of Health $10 billion and the FDA $550 million in new funding over five years.

New money (for research for unmet needs?) at least sounds like good news.

"...we took our time drafting the 21st Century Cures Act, worked very closely with the top officials at FDA and included leaders from across all facets of healthcare innovation in our effort."

"All facets of healthcare innovation"? Who is and is not included in that? I also feel confused.

 

[alex3619]

I think only time will tell, some of the implications is probably letting dying patients try drugs that are in the pipeline. Seems reasonable to me!

That has usually been an accepted practice though I think there are a lot of hurdles which are country and possibly even state dependent. If you are dying then some chance might be better than no chance.

 

[*GG*]

That has usually been an accepted practice though I think there are a lot of hurdles which are country and possibly even state dependent. If you are dying then some chance might be better than no chance.

No, I don't think it is an accepted practice. I remember of a young married couple, the wife had Cancer, if I recall correctly, and had less than a year to live. She died and never received the drug that was in the pipeline, that might have helped.

GG

 

[alex3619]

No, I don't think it is an accepted practice. I remember of a young married couple, the wife had Cancer, if I recall correctly, and had less than a year to live. She died and never received the drug that was in the pipeline, that might have helped.

GG

That comes down to hurdles and barriers. It is probably something that is widely done, but it isn't easy to do. Furthermore by the time you figure out all the barriers and how to work around them you could be dead. To complicate matters its often the case that the drug companies require patients to enroll as test subjects. Its not just given without strings. You might also have to pay for the treatment, which will not be covered by insurance.

Take Ampligen for example. Lots of patients were on that outside of existing trials organized trials, and probably still are. Maybe someone still getting Ampligen can comment.

 

[Denise]

Two of FDA's programs that might be relevant to this discussion are the
Expanded Access/Compassionate Use program (http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm20080392.htm)
and

Investigational and Off-Label Drug Use program (http://www.fda.gov/ForPatients/Other/OffLabel/ucm20041767.htm).

 

[sarah darwins]

@sarah darwins

I could be wrong but I think the approval times are after all the years of studies, ect.

OK, I think I understand. So there are two different things here — the development time and the official approval process. It sounds a bit like this bill is aimed at lowering the bar in the second part. I have no idea if that's a good thing or a bad thing. Or both.

 

[*GG*]

LOL, I would say less time for approval is better, bureaucracies kill more people than they help!

GG