Tag Archives: Food and Drug Administration

Why cheaper drugs may not be good news for patients

English: Methylphenidate packages from several...

Wikipedia

 

Major  drug companies

facing  job losses

and closures

 

For years it has been known that drug companies have a very, very close relationship with Doctors and the NHS.

Some would have said too close, especially those cancer patients who suffered from drug side effects and found doctors surprisingly unhelpful.

  •  But there were advantages.  Drug companies needed help from NHS to run clinical trials.
  • Patients who took part in clinical trials were told that they had much better chances.
  • And the end result was cancer survival rates generally improved.

In the ’80s and ’90s, people and politicians began to talk openly about cancer.  Drug companies realised there were billions to be made in producing drugs that helped prolong the life of cancer patients, and started to invest heavily in research and trials, searching for the holy grail of cancer treatment.

Drug companies became the darlings of the stock market.  Yes, the initial outlay was stupendous. But, if a pharmaceutical manufacturer came up with a drug that could be prescribed to treat cancer and prolong life, this was almost a licence to print money.  Don’t knock it though – if you have a company pension it was probably a big investor in drug company shares, seen as ‘blue chip’ investments.

But now there is a new problem looming:  cheap Generic Drugs.

Rise of Generic Drugs

A generic drug is a drug defined as “a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.

A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.   The FDA’s use of the word “identical” is very much a legal interpretation, and is not literal.

This has meant that generic drugs can have cheaper ingredients, which can sometimes react badly on patients.  But because they are cheaper, NHS doctors will always prescribe a generic drug if one is available;  and where patients have to buy their own drugs, they will tend to buy the cheaper version.  And many insurance companies will only pay for the cheaper version.  Hence drug companies will lose out.

Most drugs are patented to ensure that the company that develops them doesn’t lose their commercial advantage by others copying the drug.  Copying would be fairly easy to do;  any company developing a drug has to let the health watchdogs know what the drug was made of – making it easy to copy a successful drug – if it weren’t for patents which make this almost impossible, due to strict legal controls.

But drugs developed during the heydays of research are now coming to the end of their 20- year patent protection, enabling other companies to copy the formula.

So who is going to be first to suffer?

This problem has been growing, and drug maker AstraZeneca has just announced that it will cut another 7,300 jobs in Britain.

This comes a year after Pfizer announced it would close its UK research site.

There are still large profits being made, but there are pressures on the whole industry.

Jonathan de Pass, chief executive of the company EvaluatePharma, says  “It’s just an immensely challenging time for big pharmaceutical companies. Their whole business model is under huge strain – the whole research model is under pressure.”

What about new drugs?

Not so easy.   As Prof.  David Phillips of the Royal Society of Chemistry told the BBC, “It’s a fact that the easy targets, in the body, for the production of drugs have, essentially, all been used up.

“The cost of producing new pharmaceuticals, new drugs, is so astronomical now that it only takes one failure of a drug which doesn’t perform as well as was expected or has side effects – one withdrawn from the market that way can really cripple a company.”

A year ago AstraZeneca wrote down £281m when it discontinued research on Motavizumab , a respiratory medicine. In February 2011, late-stage clinical trials were halted on the prostate cancer drug zibotentan.

Patents usually last 20 years, during which market exclusivity allows companies to recover the research and development costs and make a profit. However, once the patent expires any company can make a “generic” version of the drug and sell it for a tiny fraction of the price.

In the USA the biggest-selling drug in the world – Lipitor (the cholesterol-lowering statin) earned Pfizer £8bn two years ago.  The patent expired in November last year and cheaper alternatives are now on offer.

This could cause a problem for AstraZeneca, as it makes a statin called Crestor. Although its patent does not run out until 2016, it has been suggested that cheap Lipitor could damage sales.

“It’s still early days, but people are going to be prescribed generic Lipitor – that is bound to have an effect,” said Mr De Pass.

So what can be done to ensure continued research into drugs of benefit to patients?

Prof.  Phillips said the key would be research on the fundamental science: “We need to get a stimulus to get that research done in the small companies and in universities so the bigger companies, later down the line, can pick up the promising leads and develop them from there.”

Co-payments

Case Study:  when a cancer patient at Chelsea and Westminster Hospital asked for Monofer (an iron-infusion for aneamia) instead of the one prescribed, which the drug makers said was more suitable for cancer patients.  The patient offered to pay the difference in price;  the hospital refused.  So the patient had the less-suitable drug infused, and six months down the line it has cost the hospital well over £1,000 to pay for consequences of giving wrong infustion – and they have now had to administer Monofer.

When Alan Johnson was Labour Minister of Health, he was made to agree that patients could co-pay for difference in drug costs.  However, this climb-down seems to have been forgotten, so it is up to patients to point out the law to the NHS, and if they would rather have a more expensive drug – they should be allowed to pay the difference.

Pension plans

Almost all pension plans will be investors in drug companies.  They are some of the largest and most profitable in the world, so it makes sense for pension plans to invest in them.  However, if they start losing money, not only will patients lose out, but their pension plan payouts will too.

So what of the future?

Drug companies are beginning to realise that they will have to become more open when talking to patients.  In Britain, we have one of worst compliance records (taking drugs) in world;  oncologists don’t have time to deal with drug side effects, so patients give up and don’t take their drugs.

This is not only bad for patients (according to World Health Organisation French cancer patients on average live over four years longer than Britons), but as we die earlier and don’t take drugs, this affects the drug companies’ profits.

Eventually drug companies will realise that to keep up their profits, so shareholders will authorise reasearch costs for new drugs, they will have to consult more with patients.  When this happens, it will be a win-win situation for both parties – but don’t hold your breath!

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Vitamin D could help handle pain from Cancer Drugs

Various pills

They prolong life - or do they make it seem longer? Wikipedia

ONCOLOGY NURSE ADVISOR

Magazine has some advice

 

A recent article in this highly-regarded magazine asked,

How do you ensure that your patients with breast cancer adhere to their aromatase inhibitor regimen, despite its painful side effects?

At last – someone acknowledges we DO have problems.

Their solution “may be a high-dose vitamin D supplement”, according to a recently published paper by Antonella L. Rastelli, MD, assistant professor of medicine at Washington University School of Medicine in St. Louis, Missouri, and colleagues.

The researchers found that high-dose vitamin D relieves joint and muscle aches for many breast cancer patients taking estrogen-lowering drugs.

Impact of Side Effects

“Although the side effects of adjuvant aromatase-inhibitor therapy are different from those associated with chemotherapy, approximately half of patients on these medications experience severe musculoskeletal pain and stiffness in the hands, wrists, knees, hips, lower back, shoulders, and feet”.

Symptoms can often be so intolerable that some patients choose to discontinue therapy.

Rastelli’s colleague, Marie E. Taylor, MD, assistant professor of radiation oncology at Washington University School of Medicine, was the first in the group to realize that patients on aromatase inhibitors who experienced this discomfort obtained some relief from high doses of vitamin D.

Aromatase inhibitors also cause bone loss. Rastelli manages a survivorship clinic for patients with breast cancer; therefore, she concentrates on bone health to lessen bone loss. Aromatase inhibitors have the opposite effect on bone mass preservation than does tamoxifen. “With aromatase inhibitors we see bone loss and fractures, and it is very important to take care of this problem early on,” Rastelli explained.

Treat the Symptoms

Patients were coming to the clinic with complaints of pain similar to the pain of osteomalacia, a condition characterized by extremely low vitamin D levels—usually less than 10 ng/mL. “These patients would tell us they hurt all over, cannot climb stairs well, and have pain in every part of their body. We did not believe these patients had overt osteomalacia, but because cancer patients often have low levels of vitamin D, we checked and found their vitamin D levels were very low,” she said.

Rastelli and her colleagues decided to treat the patients who were in pain with high doses of vitamin D. Many of them reported their aches were more tolerable or completely resolved. Some said their energy level improved as well. Rastelli’s group decided to design a double-blind, placebo-controlled trial to confirm that their patients’ results were more than a placebo effect.

Trial

They enrolled 60 patients who had pain and discomfort associated with anastrozole (Arimidex, generics), one of three FDA-approved aromatase inhibitors. (The other FDA-approved aromatase inhibitors, letrozole [Femara, generics] and exemestane [Aromasin, generic], also cause musculoskeletal symptoms.)

In addition to pain, all study participants also had low vitamin D levels. Half of them were randomly assigned to receive the recommended daily dose of vitamin D3 (400 IU) plus a 50,000-unit vitamin D2 capsule once a week. The other half received the recommended daily dose of 400 IU of vitamin D3 plus a weekly placebo capsule. All of the participants took 1,000 mg of calcium daily throughout the study.

The high-dose vitamin D formula used was the plant-derived D2. Although the D2 dose was prescription-strength, the researchers stressed its safety due to its rapid elimination. D2 is usually eliminated 7 to 10 days after ingestion. Vitamin D3, which is animal-derived, stays in the system longer (more than 15 days) and can build up, especially at high doses. The researchers also noted that some study participants returned to the clinic after being switched from a weekly regimen to a monthly regimen, reporting they felt better on the weekly regimen than they did on the monthly regimen. Apparently, this finding was the result of how rapidly vitamin D2 is metabolized: in order for the effect to persist the patient must take it weekly.

Longer-term treatment 

Patients were allowed to continue taking NSAIDs or acetaminophen during the study, if they chose; however, those patients who did experienced minimal benefit. Of course, these analgesics cannot be taken safely for a long time. Rastelli emphasized, “We have to consider this regimen long term. Patients have to stay on the aromatase inhibitors for at least 5 years, if not longer.”

Oncologists now believe that if patients tolerate the drug fairly well and are not having tremendous bone loss, they should continue therapy for a longer period.

Some studies suggest that patients who develop joint aches and arthralgia symptoms may be the ones who benefit the most from the medication, and they may even have fewer recurrences of breast cancer. Therefore, it is very important to keep these patients more comfortable and capable of continuing aromatase inhibitor therapy.

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Are airports putting cancer patients lives at risk?

Anti-terrorism measures

set to impact on cancer patients

 

 MEP Syed Kamal is working to try and resolve problems for cancer patients.

 

Anyone who flies will know that anti-terrorism checks can take up more time than the flight itself.

No-one would grudge spending this time, if it is for our safety – BUT – the very equipment that is about to come into use could put cancer patients’ lives at risk.

Currently in Britain we are trialling new types of so-called X-ray backscatter machines.

In the States these machines have been trialled for over a year, and when introduced caused enormous concerns.

Research said  that they were safe

  • but how safe was the research?
  • and who had paid for this?

Don’t forget manufacturers of these machines stand to make billions world wide once they are adopted.  They are coy about price (saying it depends on individual airports) but one U.S. site gave an approx. figure around £110,000 per machine. Each airport security gate is going to need at least one machine, and probably more for heavy traffic.   Major airports could be made to install multiple machines per exit – you’ll need big envelope to work out cost of that!

Where America leads – we follow

In the States, concerns raised by Congress and others over full-body scanners used at airports have prompted the head of the Transportation Security Administration to order that  they undergo further testing to address a “perception” they are unsafe.

Regulating these machines falls under the TSA’s jurisdiction—and it doesn’t see what all the fuss is about. The TSA has repeatedly asserted that these machines are safe despite widely-held scientific opinion that even modest doses of ionizing radiation can increase one’s cancer risk;  research is suggesting that as many as 100 people a year could contract cancer on account of this exposure—although the amount of radiation emitted from each machine is small.

In its defense, the TSA has supplied research studies supporting this point, though none of them have been published in a peer-reviewed journal (normally mandatory for any research to be accepted).

And America’s Food and Drug Administration, the strict Government controlled body, has no jurisdiction over approving these machines, as it can only test medical equipment.

However, the great John is now admitting, “I am concerned that there’s a perception that they’re not as safe as they could be”.

Newark Liberty and Philadelphia International airports are equipped with millimeter wave scanners, which use radio waves, not X-rays, to peer through passengers’ clothes, and so far have not been linked to health risks.

Administrator has red face

Researchers have raised concerns that even the tiny dose of radiation emitted by the scanners could mean a small number of fliers contract cancer. But with the TSA saying the machines are safe, Pistole told senators one scan exposes fliers to 1/1000th of the amount of radiation they would get from a chest X-ray.

Rep. Rush Holt (D-12th Dist.), a long-time critic of X-ray scanners, issued a statement in reaction to Pistole’s congressional testimony,

“I would hope that the TSA wants to deal with facts, not just perceptions,” said Holt, who in April co-sponsored a bill to ban all scanners until the National Academy of Sciences deemed them safe. “No one should be subjected to radiation unnecessarily.”

TSA Administrator John Pistole eventually had to apologise when these machines were introduced.  Operators made such a hash of the procedure that the great John was made to apologise – abjectly – to cancer patients who had been mortified by procedure.

This wouldn’t happen in UK;  in States cancer charities are all-powerful, made a huge media fuss and forced Pistole to go on TV and apologise in person.  Here, although cancer  charities have tried to raise concerns, these are arrogantly ignored by our Dept. for Transport (DfT), equivalent of the TSA.  Cancer patients aren’t seen as a threat – we are too polite.

MEP carrying out campaign

Whatever we think of Brussels and the EU, one very good thing is our representative MEPs;  very like MPs were in the old days.  They don’t have to do what they are told by the Party – normally they act according to what is wanted by their constituents.

So when I contacted my MEP, Syed Kamal, and told him of my concerns, immediately he came back to say he would be raising a question in the EU Parliament.  In the succeeding twelve months he has asked another question, been in constant touch with our major cancer charities, and even had a meeting with the BAA.

What would reassure cancer patients?

The Thalimodide disaster is still recent history.  Millions of women were reassured it was safe during pregnancy, and ended up with deformed children.  So the public’s fears should be listened to, as we don’t want similar disasters.

In the States, Passengers can opt out of scans in favor of a metal detector test and a pat-down.

This is what cancer charities in the UK are asking for – but the arrogant DfT has refused.

Last month a dentist, travelling through Manchester Airport, asked that instead of going through the machine, as his job exposes him to high levels of rays, could be have a pat-down instead?  Told no, he decided he couldn’t take the risk, and went home.

This is a really sad indication of the arrogance of airport authorities.

Background

David Brenner, a Columbia University radiological researcher, has said X-ray scanners delivered a radiation dose 20 times higher than the figure reported by the TSA, when specifically gauging exposure to the scalp.

In October 2011, Pistole told the committee he would retest the X-ray machines, when senators raised the issue one day after publication of a story by ProPublica and PBS New Hour reporting that officials had downplayed concerns about the scanners.

In August, Pistole responded to privacy concerns by announcing that scanners would be reprogrammed to produce generic imagery, rather than anatomically detailed outlines of individual fliers’ bodies.  But when cancer charities were surveyed, most respondents replied that they weren’t too concerned about the image of their bodies appearing on a screen.

What you can do

Ask the airline you fly by what is procedure – then if their airport is using these machines, express concern and threaten to take the car, go by Eurostar, or cancel your flight.  When airlines see profits being hit – they will put pressure on DfT to offer cancer patients a sensible alternative.

The only reason why DfT won’t agree is that it will take more time to train the lowly-paid airport ‘security’ staff in how to give acceptable pat-downs (there have been some memorable incidents when they didn’t heed passengers’ warnings over stoma bags).  So it boils down to a question of cost, whilst cancer patients’ genuine fears are ignored.

And your call could be what tips the scales.  Currently the DfT’s Press Office is very jittery – a sure sign they know they are being wrong-footed of policy.  Supposedly no-one was in office until 1000 (there is supposed to be a press officer in from 0800 – so if they are not available ….) then when I asked a normal question about what is cost of each machine, suddenly they say they don’t have to answer that.  So ask the Airport Security Desk who makes the machines?  and get a very suspicious answer, “I’ll come back to you on that”.

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It's Patients' Week – and hospital food shows signs of improvement

 

Putting the ‘oooh’

back into food

Do you remember when you were young, and ill in bed – your Mum coming in with a tray with lots of tempting food?

Well, thanks to James Martin and other brave chefs, Danielle Faulkner of British Food Fortnight says,

“there has been a significant uptake of hospitals taking part in British Food Fortnight this year.

 

Chelsea and Westminster Hospital had a fruit cart outside the door;  sadly, with the cold weather this has disappeared, but whilst it was there friends could buy small packets of delicious peaches, cherries, bananas and other fruit, hygienically wrapped, and easy to carry in to patients.

Perhaps the Governors might be a bit more pro-active and give the vendor permission to operate inside the hospital?  After all, they permit flowers to be sold inside the foyer.

Some of the hospitals who have been in contact with British Food Fortnight include:

  • Roseberry Park Hospital
  • Royal Brompton Hospital
  • Countess of Chester Hospital
  • Southmead Hospital
  • Basildon Hospital

although many more take part too!

British Food Fortnight

Next year dates 27 July – 12 Aug  –   during the Olympics!

If you want to improve your hospital food, keep on at Governors.

Make them realise you are worried about the amount of hospital food that is thrown away.

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Bisphosphonates and other Osteoporosis news

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Latest news

 


In the States, the FDA (Food and Drug advisory committee) wants the agency to limit the duration of bisphosphonate therapy for treatment of osteoporosis.

But the committee could not agree on what that time limit should be.  However, their findings are below.

While in Britain, there are very, very small signs that the ‘new’ NHS                                                                                                                  might be looking for ways  to increase revenue from hospitals, and osteoporosis patients could benefit.

Exercise for Osteoporosis

With the NHS desperately looking for ideas to increase funding, now is the time to hit hospitals with ideas to provide exercise classes for those with osteopororis.  Even – what a revolutionary idea! – help prevent patients getting the disease.

Called to a discussion with a Foundation Hospital, it was evident that they were finally receptive to ideas to increase revenue.  Talking over requirements for exercise classes, their eyes lit up when I cited another hospital where patients were willing to pay £7 or £8 for other classes, provided they could come in every week.  There had been talk about this being a ‘club’ whose members only met to gossip – but when it was pointed out that this ‘club’ were happy to pay the fees ad infinitum as long as they could feel they were getting exercise, ideas changed.

This also meant that once patients had received a referral letter, they then went on to pay for classes so there would be no need to stop after six weeks for usual referrals.  Once set up, the classes could continue without much administration.

What is needed

Hospital gym with suitable exercise equipment :  with

  • treadmill
  • wobble boards
  • bouncer
  • anything encouraging weight-bearing exercises

A physio to supervice, set the class in motion, give out exercises that progress from 5 – 10 different stations, then give call when it is time to move to next station.  Once first induction class was over, generally patients followed a pattern themselves, and only needed ‘keeping an eye on’.

Once set up, regular patients knew exactly what they need to do, and were content to move around the room when given ‘time up’ signal.

How to find members

Initial administration costs would come with finding patients willing to take classes.  In this area these came via LINk, OAPs clubs, GP referral, Cancer support centres, word of mouth, etc.  Signs are that more classes are going to have to be organised.

Times

If the gym is fully utilised, these classes can easily take place after normal closing time – say 4 pm to 8 pm.

There were plenty of Physios happy to supervise if they received overtime payment.

What Patients can do

Set up a discussion with the hospital Chief Executive;  and/or PALS.  Get Governors involved, or if there is one – the hospital Patients’ Association.  Ask your GP to lobby.

Find out from Physios if they would be prepared to supervise classes – and possibly work overtime in the evening.

Get a list of possible class members.

Then present this to the hospital – and Good Luck!

BISPHOSPHONATES

Earlier this year, the FDA in America required that all bisphosphonates used to prevent or treat osteoporosis warn on their labels that optimal duration of use hasn’t been determined, and that all patients on bisphosphonate therapy should have their need for continued therapy re-evaluated periodically.

This issue has become a hot potato for the FDA, as reports have emerged linking long-time bisphosphonate therapy with increased risk of atypical fractures.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee has discussed whether emerging reports of adverse events should spur the FDA to change the label to indicate that the drug should not be used long term.

Committee members voted 17-6 to endorse a label change — but then backed away from setting a hard deadline, citing a lack of data to pinpoint an ideal therapeutic time limit.

Placebo-controlled trials typically provide data for only five years of therapy, but there is no strong clinical evidence that bisphosphonates work better after they’re used for a long period of time, nor is there firm evidence that long-term use causes harm, the panel said.

Bisphosphonates are prescribed to some five million patients annually to stave off or treat osteoporosis and are highly effective at reducing the risk of osteoporotic fractures. In the States, brand-names Actonel, Atelvia, Boniva, and Reclast, have been shown to reduce the risk of breaking a hip by 40% to 50% and fracturing a vertebra by between 40% and 70% by inhibiting bone resorption to prevent loss of bone mass.

Latest information

In 2010, the FDA required makers of bisphosphonate drugs to add a warning to their labels about a small increased risk of atypical femur fractures after an American Society for Bone and Mineral Research task force concluded that the risk, although it is small, is real.

The panel heard from women who were taking bisphosphonates to prevent osteoporosis when suddenly and painfully, they broke their femurs. One woman was on a subway train that screeched to a halt, and as her weight was thrust onto one leg, her femur snapped and she collapsed. Other women had similar stories — a teacher reaching something in front of her students, a grandmother taking a large step to walk toward her grandchild, a woman walking down a front stoop to pick up the morning newspaper — and in each case the women collapsed to the ground as their femurs snapped.

The panel was also concerned with the drug’s link to deterioration of the jawbone. In 2005, the FDA added a warning on bisphosphonates about osteonecrosis of the jaw, a rare disease in which the bone in the jaw dies. In data presented Friday, an FDA reviewer said the risk for osteonecrosis of the jaw appears more prevalent after four years or more of use.

There are also some data suggesting a link to long-term use of bisphosphonates and esophageal cancer, although solid evidence is lacking, the panel said. In 2009, a study in the New England Journal of Medicine used data from FDA’s Adverse Event Reporting System to identify and describe 23 patients taking alendronate who were diagnosed with esophageal cancer.

Findings

Taken together, there’s no clear answer on the long-term safety of bisphosphonate therapy for the prevention and treatment of osteoporosis, the panel said and called for more studies to hone in on the long-term risks and benefits of the drug.

“There’s no doubt that these are very efficacious drugs that reduce fractures and mortality, and there are many women who should be on these drugs that aren’t on them,” said Sonia Hernandez Diaz, MD, associate professor of epidemiology at Harvard School of Public Health. “But what we’re talking about today is using these drugs for more than three years, and I’m not convinced at all that there are any good data that, even for subgroups of patients, they should be continued [past three years].”

The panel was also asked to discuss the idea of a “drug holiday” or taking a break for bisphosphonate treatment in order to minimize risks, but agreed there wasn’t enough evidence to warrant recommending a drug holiday as a treatment plan.

More information:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm

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Drug companies versus Government agencies

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AFTER ALL THE DRAMA

WHERE IS USA ON THE 

AVASTIN ISSUE?

 

FREEDOM OF ACCESS TO MEDICINES NEWSLETTER (FAMEDS) has just published a very interesting update to the row going on in the States over the drug Avastin.

FAMEDS say, “on the surface things may look quite bad but in reality, matters are on target to turn out rather well”.

This is interesting news for people abroad, particularly in Britain, with the NHS poised to crack down on expensive drugs under the Health Bill – wrapped up under ‘consumer benefits’ etc.  Already many NHS patients are experiencing problems when renewing their prescriptions.

Drug companies Genetech and Roche, the makers of Avastin, aren’t going to give up without a fight.  You might remember their campaign song, brilliantly composed to sound like a college kid fighting for his mother

and with a lot of humour, which always gets them.

Latest update

Things look bad because of the four 6-0 decisions made by the Oncologic Drug Advisory Board (ODAC) against Avastin at the FDA hearing on June 29, 2011. As FAMEDS had warned before the hearing, ODAC was nothing but a Kangaroo court whose members had made up their minds prior to the hearing.

Lest we think the FDA and ODAC, “got away with it”, think again. Because of the brazen actions taken against Avastin, Congress is very likely to insist on major changes to future FDA advisory boards. These changes will come as a direct result of the Avastin debacle, where only six of the 13 ODAC members even showed for the June hearing. The reform of ODAC and other FDA advisory boards is tied to renewal of the Prescription Drug User Fee Act (PDUFA), which throws off a lot of revenue to the FDA from the drug companies. The FDA wants this act reauthorized in 2012 and but will only see this occur with major changes to ODAC, the selection of ODAC members, etc. This reform comes too late for the Avastin decision but it will benefit all those affected by future hearings regarding other drugs.

FAMEDS followed the strategy of creating sufficient noise against the FDA in the belief that this would dissuade the Centers for Medicare and Medicaid Services (CMS) from following the same route.

This appears to have worked.  But those of us worried about the provisions of Britain’s Health Bill, should watch carefully what has happened, and sharpen those pens, swords etc.!

Current position in the States

Even though there are no final rulings, FAMEDS believes that Avastin will continue to be available for those current Avastin patients who are either currently covered by Medicare or who will become eligible in the future.

The next question is this: what about those women taking Avastin who are not covered by Medicare and who are unlikely to be eligible any time soon? These are the patients, primarily younger, currently using private insurance. FAMEDS believes that the majority of these patients will continue to be covered by their private insurers, many of whom follow the NCCN guidelines. The National Comprehensive Cancer Network (NCCN) voted again recently 24-0 to retain Avastin for use with Taxol (a chemotherapy) for treating women with metastatic breast cancer.

NCCN experts recommend bevacizumab for treating metastatic breast cancer

There are likely to be some private insurers who balk at Avastin coverage for women with MBC; these companies are not known for their benevolence. FAMEDS stands ready to publicly pressure these “outlier” insurers if that is required and we will seek your help to create this pressure. Furthermore, FAMEDS believes that for the small percentage of patients covered neither by CMS nor by private insurance that Genentech, the manufacturer of Avastin, should step up and cover these women on a compassionate use basis. In summary, while this is all speculation, FAMEDS believes that all current patients using Avastin for MBC will continue to receive the drug and will be covered by insurance or the donation of Avastin. It is our collective duty to make sure that this becomes reality.

In Future

The bigger question is what happens to the women who are not current Avastin patients but whose oncologists wish to prescribe this drug in future? Here the picture is less bright and even more speculative. At best CMS and some private insurers might still provide coverage for the use of Avastin with a few selected chemotherapies, such as Taxol, which have shown the best results with Avastin. The worst-case scenario is that future patients will be covered neither by CMS nor by private insurance. FAMEDS is cautiously optimistic that CMS will provide coverage for some limited use possibly with other restrictions in place. As Genentech has committed to further trials of Avastin with Taxol, usage may be tied in some way to the results of these future trials.

August 4th was the deadline for submitting public comments to the FDA’s docket. As with most soap operas, the Avastin saga featured some last minute drama when Genentech submitted a so-called “middle ground” option to the FDA for their consideration, on the last day for submissions. Among other requests, Genentech asked for special exemptions for triple negative and her2-negative breast cancer patients. These patients have few options for treatment, as they do not respond to most drugs on the market.

This has created a further dilemma for FDA Commissioner Margaret Hamburg, who will soon make the final decision on Avastin. There has been much speculation that she will rule on August 15, 2011 or thereabouts but FAMEDS does not think this likely. For the FDA to process this most recent request by Genentech as well as all the other public comments submitted will take at least through September and possibly into October.

The pressure on Dr. Hamburg is enormous and this is likely to be her biggest decision as head of the FDA. On the one hand, if she overrules the decision of Avastin, she will incur the wrath of her staff and undermine their current modus operandi. On the other hand, we have the Avastin patients and their advocates, the NCCN, many oncologists, and some members of Congress who will not take kindly to a negative decision on Avastin.

As the FDA and CMS are both part of Health and Human Services (HHS) and as all heads are political appointees, the decision is likely to take political realities into account. With the 2012 elections on the horizon, the President does not need another election issue on his plate, with charges of rationing, death panels, etc. FAMEDS believes that the Secretary of HHS, Kathleen Sibelius, will broker a deal between CMS and the FDA, if she has not done so already. The deal will be essentially this: the FDA will continue its negative stance against Avastin when Commissioner Hamburg rules but the political fallout will be limited by CMS’s coverage of patients. It is possible that Dr. Hamburg will surprise us with some limited exemptions (such as grandfathering in current patients) for Avastin but FAMEDS is not overly optimistic based on the FDA’s consistent stance against Avastin.

However, depending on CMS’s continued coverage of Avastin, Commissioner Hamburg’s much anticipated decision may be of little practical importance. Follow the money, which right now needs to come from CMS, the private insurers and Genentech.

While we await the outcome of this epic battle, we thank you, the loyal supporters of FAMEDS, for your continued support of these brave women. If FAMEDS is correct in its speculation as to the outcome, this will only have been possible because of the public outcry over this matter.

You have been warned – NICE may replay this scenario very shortly over many of the cancer drugs we take.  I only hope not – but ….

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FDA says NO to Avastin for breast cancer

Fda

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America’s Food and Drug Agency

turns down Avastin appeal

 

In Washington, advisers to the Food and Drug Administration voted 6-0 to halt the use of cancer drug Avastin for the treatment of breast cancer.

They say studies have failed to show Avastin is effective for that purpose.

Makers Genetech had mustered a mass of testimonies from doctors and advocacy groups, and patients such as  Crystal Hanna, a mother of two who will celebrate her 36th birthday Friday.

“I’m a testament that the drug does work…I’m not just a statistic,” she said. “Keep breast cancer on the label so that I and others like me can celebrate more birthdays.”

This was a very hard-fought political battle, and Advisers acknowledged the emotional nature of the issue, but said  science should prevail. “I think we all wanted Avastin to succeed,” said Natalie Compagni-Portis, a member of the committee. “And yet what we have to do today is respond to the research that’s been presented to us…these studies didn’t bear out that hope.”

The drug will remain on the market for other cancer treatments, but the FDA’s withdrawal will likely mean insurance companies won’t cover it for breast cancer patients. As a result, many women won’t be able to afford the treatments, which can cost up to $100,000 a year.

Though the FDA will make the final decision, it rarely ignores recommendations of its advisers. One of the rare instances was in 2008, when the agency approved Avastin for breast cancer treatment for the first time. The decision came under the agency’s “accelerated approval” process, which fast-tracks potentially life-saving drugs on a conditional basis.

WASHINGTON…A panel of advisers to the Food and Drug Administration voted 6-0 to halt the use of cancer drug Avastin for the treatment of breast cancer, saying studies have failed to show Avastin is effective for that purpose.

The recommendation Wednesday came after two days of testimony from patients, doctors, and advocacy groups. The panel faced several tearful accounts, like that of Crystal Hanna, a mother of two who will celebrate her 36th birthday Friday. “I’m a testament that the drug does work…I’m not just a statistic,” she said. “Keep breast cancer on the label so that I and others like me can celebrate more birthdays.”

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Advisers acknowledged the emotional nature of the issue, but said the science should prevail. “I think we all wanted Avastin to succeed,” said Natalie Compagni-Portis, a member of the committee. “And yet what we have to do today is respond to the research that’s been presented to us…these studies didn’t bear out that hope.”

The drug will remain on the market for other cancer treatments, but the FDA’s withdrawal will likely mean insurance companies won’t cover it for breast cancer patients. As a result, many women won’t be able to afford the treatments, which can cost up to $100,000 a year.

Though the FDA will make the final decision, it rarely ignores recommendations of its advisers. One of the rare instances was in 2008, when the agency approved Avastin for breast cancer treatment for the first time. The decision came under the agency’s “accelerated approval” process, which fast-tracks potentially life-saving drugs on a conditional basis.

Approval was based on a single study by the manufacturer, which suggested the drug prevented the disease from advancing for an average of 5.5 months. But subsequent studies have failed to replicate the results, and have shown the drug carries serious risks like high blood pressure, heart attacks, and bleeding.

“We are very disappointed by the committee’s recommendation,” said Krysta Pellegrino, a spokesperson for Genentech, which is based in South San Francisco. The company has successfully marketed Avastin as a blockbuster drug for treating colon, lung, and brain cancers.

What next?

According to reports, approval was based on a single study by the manufacturer, which suggested the drug prevented the disease from advancing for an average of 5.5 months. But it was said that subsequent studies failed to replicate the results, and showed the drug can carry serious risks like high blood pressure, heart attacks, and bleeding.

In Britain, this might mean drug companies paying much more attention to keeping patients happy, instead of ignoring side effects that patients present.  With the new broom sweeping through the NHS, patients are going to be demanding value for money, and questioning if the sometimes horrendous side effects actually produce a compensating benefit to them, rather than the drug company’s profits.

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Sensible advice when taking new drugs

Homewood Museum, Johns Hopkins University, Bal...

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Why don’t they tell us?

Johns Hopkins University in Baltimore, USA, has one of the most renowned medical research establishments in the cancer field.

So when they advise on how to take new drugs – I listen.

 

And their latest research makes a lot of sense;  they advise when you begin a new medication, the key to avoiding side effects is to take the lowest possible dosage that still gives you the benefit you need — whether that intended benefit is relieving arthritis pain, reducing cholesterol levels, or maintaining healthy levels of blood sugar to prevent the long-term complications of diabetes.

Unfortunately, there is frequently no “one size fits all” dosage, because people vary in their responses to drugs.  So when your doctor says ‘take X pills a day’, they could be advising a dose for someone larger or smaller than you.

Johns Hopkins says “the dosage must be tailored to you and your specific medical needs. The goal is to identify the minimum effective dosage of the drug: one that provides sufficient benefit with minimum side effects and at the lowest cost. On the other hand, the maximum useful dosage is the point beyond which increasing the dosage offers no additional benefit and, potentially, increases the risk of side effects”.

As a rough analogy, consider the process you go through to salt your food. You first sprinkle a bit on, but you can’t quite taste the salt. So you sprinkle a little more, and now it tastes just right — akin to the minimum effective dosage. Add a little more and the food will taste distinctly salty but remain edible, akin to the maximum useful dosage. Finally, give the shaker a few more shakes and the food will be too salty for eating. Now you are experiencing a side effect from too much salt: unpleasant-tasting food.

Finding the minimum effective dosage of a drug depends a lot on your doctor’s experience, skill, and judgment. You may also have to undergo tests to determine whether the drug is working as expected. For example, drugs for high blood pressure take time to exert their maximal effect. Doctors commonly start at a low dosage and gradually increase it until they see an adequate treatment response. This, of course, means you will have to undergo periodic blood pressure measurements.

This sounds eminently sensible to me – and advice that might have saved me from nasty side effects with drugs I have taken previously.

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Sometimes, we DO know best when it comes to our health

Capsules
Image by Auntie P via Flickr

Side effects of cancer drugs

often surface years after

drug approval

.

Have you had a medical problem, which you think might have been caused by one of the drugs you are prescribed – but doctors pooh – poohed any suggestion these might be the cause?

Recently Reuters Health reported  on a story released by Canadian researchers, saying that  “serious and sometimes life-threatening side effects often go unreported until years after cancer drugs have been approved”.  Reuters Health compiles serious analysises of medical research and treatment emanating from major studies.

For many patients, drugs are life-extending.  We wouldn’t have improved survival statistics if it wasn’t for these products.  However, a growing minority are experiencing side effects caused by these drugs – some of which are very nasty.

Sounds familiar?

When asked if they have experienced problems, for many cancer patients the answer will be a resounding yes.  Often   they have tried to get their medical team to listen if  they report  problems, but find it impossible to get them to even check if symptoms might – just might – be caused by a drug they were or are on.

If you have experienced problems, researchers from the University of Toronto have discovered, “within four years of approval, five of the 12 drugs they looked at had earned a “black box warning” from the U.S. Food and Drug Administration, which approves new medications”.

The research was led by Prof. Ian F. Tannock, who says  “it’s a warning to be very careful.,”  Tannock is an oncologist at the University of Toronto, and said “patients need to be informed that with a new agent there may be added risks.”

Tannock’s team examined so-called targeted therapies, a budding class of cancer drugs that work by interfering with specific molecules involved in tumor growth. Therefore it was expected that the medicines would be safer than traditional chemotherapy.

However, results questioned this assumption.  When questioned by Reuters Health, Dr. Thomas J. George commented, “it’s concerning to say the least. When we as oncologists prescribe new therapies we have to be on the constant lookout for side effects and outcomes that aren’t necessarily what the trials would have predicted,” added George, of the University of Florida.   (George was not involved in the study).

The new findings come in the wake of research showing that most trials of experimental cancer drugs report increases in at least one severe or life-threatening side effect.

So what about your experiences?

You might have had nasty problems, and wondered if these were caused by the drugs you were put on.  But when you ask your oncologist, they tell you, “I have never seen/heard of this before”.

But they need to be more vigilant, and keep up with what the researchers come up with.

After all, who would have connected carpal tunnel syndrome with a commonly-prescribed aromatase inhibitor?  Or heart problems, skin lesions, blindness, etc?  All symptoms that have recently been acknowledged as possibly been caused by drugs patients were taking.

Some of these horrid conditions may have had nothing to do with the drugs they were taking, but the medical profession needs to undertake more research and LISTEN to patients, before they dismiss their fears.  Most patients won’t challenge a doctor, but sadly they often need to do so.

Why does this happen?

According to the Reuters report, one reason why this can happen is that trials, which form the basis for FDA drug approval, might be too small for rare side effects to surface, or they include only highly select patients.

To help yourself, you can now point to this research, and other studies, and demand more investigation.

What happens in UK

In Britain, cancer survivors have long suspected that drugs they are on might cause problems, but with the limited average of ten minutes allocated for an NHS visit to an oncologist in Clinic, many don’t have time to discuss what might be causing these.  The solution is often the easy option of  “come off the drugs”.

This is not fair on the patient, who wants the reassurance that the drugs might help them to live longer.  But may well be a contributory factor to why, in Britain, our survival rates lag behind those of most European countries.  From personal experience, when I had nasty side effects, and had been told to “come off the drugs”, I didn’t.  Instead I went off to hospitals in France and Germany, where the side effects I experienced were well documented, and immediately the doctors to whom I spoke suggested clinically trialled solutions – which worked.

But this took time :  the doctors had to listen to me, examine me, take samples, swabs,  go through my medical notes, ask questions, etc.  in order to come up with a solution which worked.  This type of treatment is something that the NHS has less and less time to offer to patients.

Or the drug companies tell the patient to “fill in the Yellow Card”.  These are a fairly long form that the patient fills in, listing symptoms.  Patients will often have to phone round to get facts confirmed.  Once filled in, they are sent off – and that’s the last the patient hears.  When I phoned to ask what had happened to ‘my Yellow Card, I was told “because of Data Protection Act   we can’t tell you – even though you filled in the card.  So I gave up.

Solution would be to be more helpful to patients, and take a pro-active stance in investigating – but drug companies hide behind convenient rules and regulations, which mean that patients have the frustration of trying to find information, but coming up against brick walls. Then they are told to go back to their doctor – the very person who has originally dismissed their concerns and told them “I have never seen this before”, or similar statements.

Or else the solution means going to a major cancer centre in Europe get solutions.  But who can afford this every time?

Why does this happen?

Tannock says the problem is that very few doctors actually look at the labels. Instead, they stick with the published studies that led to the drug’s approval and first label.

Focusing only on drugs with updated labels, Tannock’s team found that half of the 76 serious side effects described in them hadn’t been on the initial label. Of potentially fatal side effects — such as blood clots, strokes and lung problems — that number was 58 percent.

“Many of the reports that led to the warnings did not come from published studies,” added Tannock, whose findings appear in the Journal of Clinical Oncology.

So if you have unexplained side effect:

Print out report link.reuters.com/byd27m

1.  Take this to your Oncologist and/or CNS

2.  And don’t take no for an answer.

Background on Prof. Ian F. Tannock

Currently working for Ontario Cancer Institure, gained his PhD at Inst. Cancer Research UK in London etc.

If you Google him you come up with a lot of very interesting info, particularly his statement, “I have a long-standing interest in improving methods for undertaking clinical trials, and especially in use of endpoints such as quality-of-life that reflect patient benefit directly. We have applied these endpoints in clinical trials for patients with prostate and breast cancer, and are interested in the mechanisms by which chemotherapy may cause fatigue and cognitive dysfunction.

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