dangerous prescription
homethe fdainterviewsdiscussion

join the discussion: Do you feel safe when you put a prescription drug in your mouth? Should the FDA speed up its drug approval process -- or take it more cautiously?

ekg photophoto of pills in handphoto of baycol

Dear FRONTLINE,

In the closing scene of 'Dangerous Prescription', Dr. John Kelly, spokesman for PhRMA, said, "[O]nce, twice, and again, last year, the Congress decided that the best way to fund the FDA was to look to the pharmaceutical industry to provide a portion of the funds to help support review. That's the decision of the Congress."

I find it remarkable that Frontline stopped there, without at least mentioning the degree to which Congressional election campaigns are underwritten by pharmaceutical industry money.

---

By the way, I'm not unsympathetic to the challenges faced by drug companies. Many pharmaceuticals truly are modern miracles, but they are difficult and costly to develop. And I'm a supporter of FDA, although a somewhat grudging one. Why? Because even a flawed FDA, working with an intensely capitalist drug industry, yields an infinitely better result than the almost total freedom from oversight that Congress has accorded the "alternative medicine" industry (which, perhaps not coincidentally, is another source of hefty campaign contributions).

Karl Sutterfield
Thornton, CO

FRONTLINE's editors respond:

On the homepage of this web site you'll find a good analytical piece, "Politics, Profits and Pharma," that looks at how the pharmaceutical industry is one of Washington's most powerful interest groups. And, on Dec. 28th 2004, FRONTLINE is rebroadcasting its much-discussed report on alternative medicine, "Alternative Fix." (You can also watch it online -- just go to our series homepage, www.pbs.org/frontline/ and click on VIEW section.

Dear FRONTLINE,

Great show! Excellent reporting on a subject that is timely and pertinent considering the growing number of us in our ìGolden Years.î I was particularly impressed with the perceptive responses from others in your viewing audience. It is comforting to know that there are others who are informed and concerned.

It is my opinion, however, the problem is not just the pharmaceutical industry. The same type of Frontline program could be presented on the military industrial complex or the oil industry. We need to treat the disease not just the symptoms.

Senator Fritz Hollings (The Post and Courier, Wednesday, November 17, 2004) is quoted as saying:
ìThe main culprit, the cancer on the body politic, is money.î ìWe donít have time for each other; we donít have time for constituents, except for the giversÖ. Weíre in real trouble.î

Letís face it. Campaign contributions are simply bribes. In my opinion, the cure for our disease is strong laws that preclude public officials from accepting money or favors in any form.

Richard Wehle
Mt Pleasant, SC

Dear FRONTLINE,

I am SHOCKED! SHOCKED I tell you to find out that the drug lobby is controlling the FDA!
FEN-PHEN, VIOXX, these were obviously mistakes!

Millions in profits have absolutly nothing to do with withholding AIDS drugs from developing nations, nor do they have anything to do with my parents, who just happen to on a fixed income, being unable to get prescription drugs from Canada.
Reason being that the drugs they receive may not be safe.
So you are telling me that American drug companies are selling unsafe drugs to the Canadian people?

Why not? They are selling them to us...

Dave Upton
Russellville, Alabama

Dear FRONTLINE,

This is the second time I watched this rerun story on the FDA and it was no easier to stomach. Of course, the latest news on Viox was added and there is talk of a new whiz bang independant oversight government group to now oversee drugs once they are approved. Well that is just great! - and so predictable. Rather than hold the FDA and their managers, at all levels, accountable for not doing their jobs in the first place, we'll just create a new group to oversee them! Then we can have even more people on the government payroll-benefits gravy train who can line their pockets and sell out the public in behalf of the drug companies.

This breaks my heart. I feel like such an idiot for loving this country so much when everything it does is so hateful and opposite to what it is supposed to stand for.

Anyway, I am old now, so I guess it doesn't matter what I think, but it sure makes me feel sorry for the American generations ahead of me who will only know this as the status quo and accept it as the norm. In the end, those with all of the money always win in America. I wonder what the founding fathers think about that as they look down on this - their gift to world.

Mark Cole

Dear FRONTLINE,

After watching this Frontline on the FDA's captalistic approach to medicine... prehaps we need a clean sweep of the FDA.
And listen to those who have left the department.

Thomas Brown

Dear FRONTLINE,

Merck just recalled its arthritis drug Vioxx, not because it had to, but because it believed it was the best thing for patients. The scale of that recall is among the billions.

Unfortunately there is no frontline coverage on that, nor the fact that medical technology today is better than ever. President Clinton has been successfully treated after his scare from heart disease using among other things; beta blockers.

Personally, i feel quite lucky to be living in this day and age. Everyone loves to target rich people and profitable corporations. The media is an effective platform for persuasion, but the facts should be looked closely.

Mr PBS

Dear FRONTLINE,

The last topic of your excellent show mentioned the expansion of the use of pharm. co. money into supporting more FDA staff for "safety" evaluations. An industry spokesman defended this as being merely following the dictates of laws passed by Congress. The show thus ends with a glaring omission: disclosure of how many millions of lobbing dollars the industry spends to influence Congress into passing such legislation in the first place.

The frightening conclusion is that within both the executive and legislative branches, the pharmaceutical industry is buying out our government!

Please follow up.

Ronald Vitale
Upper Saddle River, NJ

Dear FRONTLINE,

You have provided an exceptionally rare opportunity for we grassroot American's to unite ,organize, stand up and in this case re-invent the mouse trap and effect the necessary overhaul from top to bottom, side to side, inside and out and let the chip's fall where they may to return to safty and effacy for all prescription and over the counter drugs I want to be part of the solution. So all ye out there with the same kind of fire in your belly, stamine ,endurance, and resilience of character and an unquenchable hunger for truth,I want hang with you to work on this grassroots endeavor.

I strongly encourage each person to read all of the supporting web site documentation FRONTLINE has provided. If you are willing to share your time for this effort free contact me or me you by e-mail and let's just do it. jlsassy1234@aol,com
l and let's just do it.

Jacqueline Lynn
Eudora,, Kansas, 66025

Dear FRONTLINE,


I felt that the show was excellent. The public needs to know that prescription medications have incredible potential for good or bad and must be respected.

I would like to comment on your coverage of who participates in Medwatch. In the hospital setting it is definitly a cooperative effort. Nurses generally report a symptom, physicians may note that symptom and a correlation to drug usage in the chart, and the pharmacy department looks at the entire picture and files a Medwatch form, if needed. (I believe that pharmacists actually file the largest number of such forms, you could check that with the FDA.)

The public needs to know that as outpatients THEY can be a valueable part of this team by suggesting filing of Medwatch forms to their doctor or pharmacist. (In the retail setting this is much harder for pharmacists as they do not generally have access to enough of the patient's record.) If you ever revisit this topic I would urge you to inform the listeners of how active they can be. They could even file their own form!



Alan Daters
riverhead, new york

Dear FRONTLINE,

One thing I noticed about the MedWatch system is that, except for the use of fax technology, it appears to be entirely manual. In such a system each adverse event report is filed under only one category, and links related to other categories can get lost. The solution is to create a Web-based system which allows the creation of adverse event reports by filling in a form on-line, such as the one on the PBS website that I am using to create this message. Then all the events associated with a given drug can be put into a database. Reports run against this database can allow an FDA employee to get answers to questions such as:

How many adverse effect reports have there been for effect A and drug B?

Such a report would take into account all the adverse events listed in one MedWatch report, not just the primary adverse event in that report.

Susan Crayne
Hartsdale, New York

Dear FRONTLINE,

I had by pass surgery in 2002, and my doctors prescribed various medications to lower my cholestrol, ie, Lipitor, Pravachol, Altocor ER, and Zocor, along with Zetia. All these medications caused pain and numbness in my legs and feet. i have subsquently
stopped taking these drugs as my pain had become to severe. My doctor had only one answer, and that was another drug.
i was very pleased to see your program on 11/13/03, Frontline, that confirms a lot for me. Prescription drugs are very harmful and dangerous.

Ken Jackson
Montebello,Ca.,

Dear FRONTLINE,

You're looking at a 57 yr old male who hasn't put a single pill in his mouth for over 25 years. Watching your expose confirms my belief that pharmaceuticals in general cannot be trusted at all. I am appalled and dismayed to see the millions who flock to pills as a soulution to what ails them. So many desperate fools, it's sad.

You've only scratched the surface. What about all those highly addictive pain killers Rush Limbaugh was reported to be hooked on ? What about the narcotic pills being given to kids, Ritalin, Adderall etc. ? How about the "revered" and actually nefarious Prozac ? What about the Dexedrin Elvis got hooked on in the US Army in Germany, which eventually led to his demise?

I expect Frontline to continue its crusade to bring to the fore the truth about the chemical-substance (prescription drugs) epidemic that is crippling the population of this pitiful planet.

Ray Prada
Saint Louis, MO

Dear FRONTLINE,

While your show was timely and informative, the American public need only to look back to the hemophilia scandal that erupted in the late 80s and early 90s to see the influence of the drug companies and the Federal government on the FDA. Both my son and my father were victims of these practices. The hemophilia community generated an enormous amount of publicity in this country and throughout the world. Sadly, the general population didn't pay as much attention as they should have. I always stated in every interview I gave that if these practices were going on with us, what was going on with other drugs? The answer seems to be the same things. Certainly I mourn the loss of my child and my father and the thousands of others who died, but I also mourn the fact that as a people we failed to learn the lessons that were there for all to see.

Judy Trullinger
Philadelphia, PA

Dear FRONTLINE,

This program needs to be repeated. As an RN and a former pharmaceutical representative I have personally seen the inside workings of drug companies and the outward effects patients suffer because physicians know virtually nothing about the medicines they prescribe. I have filed Med watches, yet found that few of my fellow professionals even know what one is. It is easier in many cases for a doctor to write another prescription to cover a side effect than to look into the problem.

We must insist that medical schools increase the number of hours students spend in pharmacology classes. We must teach all health care providers to file Med watches. And we must not allow an agency which has failed to protect us, any access to controlling our herbs and vitamins.

As our population ages, it is even more imperative that we address the problems which surround the prescribing of pharmaceutical therapies.

Sandy Wilks

Dear FRONTLINE,

Thanks for a very informative program - However, it would seem
you have just scratched the surface of this problem. We need a more immediate means to understand these drugs! How about a BLOG that addresses drug reactions / interactions that would be run by the FDA or someone like Consumer Reports that we could trust to keep the discussion to stay on track?

WE can't trust the Drug companies to inform us!

Roger Rydberg
Plymouth, MN

Dear FRONTLINE,

As a consultant working with a range of pharmaceutical companies over 20 years, I would like to contribute three comments.

First, I think that the FDA interviews have underestimated the enormous cohersive power that the FDA has upon the pharmaceutical industry. When the FDA "suggests" a voluntary action by the manufacturer, the only response by a mature company will be "how high should I jump?".

There are famous examples of one or two new biotech companies challenging the FDA, and the dire consequences to those companies. For example, in the case of Cetus, a CEO lost his job over disagreeing with the FDA. The FDA power to delay the review of a new drug application is sufficient for any mature pharmaceutical company to bend over backwards to accomodate the agency. This cohersive power is healthy for the strength of the agency and the protection of the consumer.

Given this climate, I can't think of any scandals I have seen involving the agency or the industry.

However, I think there is one huge scandal that is tolerated on an ongoing basis. Adverse event reporting is mandatory for manufacturers, distributors and even hospital-based pharmacists, but it is entirely voluntary for physicians, the ones who are in the best (and sometimes only) position to observe and report the adverse events. The problem here is that physicians feel that they may share some liability in the adverse event, that is, it may have happened because the drug was mis-prescribed. The status quo of the federal government avoiding legislation requiring mandatory adverse event reporting by physicians is perhaps the biggest scandal in the US pharmaceutical system. By contrast, reporting is mandatory for physicians in Europe.

Another "scandal" that is tolerated is that medical and surgical procedures are not regulated in any way comparable to regulation of drugs and devices. Doctors are relatively free to offer the most unbelievably risky procedures for patients (in spite of the fact that human experimentation is subject to local institutional review boards, and doctors are subject to revocation of hospital admitting privileges - but these are more local "peer-review" processes). Did you ever wonder how liposuction ever came into practice? When I was a physician in training (1973-1977), surgeons would laugh at me when I asked why fat tissue could not be surgically removed. They said it would leave major physical deformities and cause uncontrollable bleeding. Yet some physician received permission to perform this medically unnecessary procedure, and now it is a major enterprise. If a medical procedure, no matter how dangerous, is done without new drugs or devices, then it is out of the jurisdiction of the FDA or any other federal agency.

In the interest of consumer protection, there is no reason why medical and surgical procedures should not be regulated in the same way that drugs and devices are regulated.

Dana Ludwig

more

 

home + introduction + hazardous to your health? + defending the fda + politics, profits & pharma + producer's notebook
producer's chat + interviews + faqs & links + a dirty dozen + discussion
tapes & transcripts + press reaction + credits + privacy policy
FRONTLINE + wgbh + pbsi

posted november 13, 2003

background photograph copyright © 2003 getty images - all rights reserved
web site copyright 1995-2014 WGBH educational foundation

 

SUPPORT PROVIDED BY

FRONTLINE on

ShopPBS