If you want to understand why U.S. health care is so expensive, take a look at the chart below. It illustrates how the price of cancer drugs has levitated in recent years, revealing how, in our largely unregulated for-profit health care industry, the seller is the price-maker and the patient is the price-taker. In other advanced countries, the government intervenes with an eye to protecting desperate patients from being gouged. In the U.S. the law specifically prohibits Medicare from trying to negotiate for discounts.
In an article titled “Limits on Medicare’s Ability to Control Rising Spending on Cancer Drugs,” published in a recent issue of the New England Journal of Medicine Dr. Peter B. Bach, a physician and epidemiologist at Memorial Sloan-Kettering Cancer Center, uses this chart to demonstrate the steep rise in Medicare spending on cancer drugs in just the past ten years.
Figure 1. Monthly and Median Costs of Cancer Drugs at the Time of Approval by the Food and Drug Administration (FDA), from 1965 through 2008.
Note that the chart tracks the monthly cost of cancer drugs (vertical axis) from 1960 to 2009 (horizontal axis). What is extraordinary is how the price of the most expensive bleeding edge treatments has jumped, since 1990, from $2,000 a month to $5,000, $10,000 and finally $25,000 a month. Meanwhile, the fine red line traces the rise in the median price of cancer drugs—from well under $1,000 a month in the late 1960s to $6,000 to $7,000 a month today.
Note that the chart tracks the monthly cost of cancer drugs (vertical axis) from 1960 to 2009 (horizontal axis). What is extraordinary is how the price of the most expensive bleeding edge treatments has jumped, since 1990, from $2,000 a month to $5,000, $10,000 and finally $25,000 a month. Meanwhile, the fine red line traces the rise in the median price of cancer drugs—from well under $1,000 a month in the late 1960s to $6,000 to $7,000 a month today.
Overall, the amount that Medicare shells out for drugs administered in a doctor’s office–— a category dominated by drugs used to treat cancer —has spiraled from $3 billion in 1997 to $11 billion in 2004 (an increase of 267%),” Bach notes. Over the same span, total Medicare spending rose from $210 billion to $309 billion (an increase of 47%).
Meanwhile, even patients who have prescription coverage under Medicare Part D face high co-pays. More Part D insurers have put brand-name drugs, including Gleevec (imatinib), Sutent (sunitinib), Tarceva (erlotinib), Thalomid, and Tykerb (lapatinib), on specialty tiers that require cost sharing of 26 to 35 percent for each prescription. Insurers begin picking up 95 percent of the drug’s cost, only after a patient’s annual out of pocket spending reaches $4,350. And many patients don’t even have Part D.
As a result, “Patients who face life-threatening illnesses are also facing out-of-pocket costs for cancer therapies that can threaten their family's financial security,” Bach observes.
“Health economists are concerned, too . . . .because the prices of cancer drugs appear to be rising faster than the health benefits associated with them, at least in some cases,” writes Bach, pointing to studies published here and here.
Big Pharma’s Eureka! Moment
How and why did this happen? In 2006 the New York Times made an announcement: “Big Pharma has discovered cancer.”
That was the first sentence of a story headlined: “New Drugs for Cancer Could Soon Flood Market.” In the past, large, traditional pharmaceutical companies such as Glaxo, Pfizer and Wyeth had shown relatively little interest in selling potions for cancer patients,, the Times explained, preferring to “make drugs for chronic diseases” rather than “treatments for cancer, where patients often die within months.” (There is a saying in the pharmaceutical industry: “a pill that cures is good; a pill that you have to take every day is better.”
Moreover, the Times pointed out: “while cancer as a whole affects many people, the market is divided into different types of cancer.” In other words, a drug that targets a particular type of cancer is limited to a small niche market made up of patients who often don’t have long to live. From a drug-maker’s perspective, this is not an enticing group of customers.
But then, a year or so before the Times article appeared, the pharmaceutical industry’s marketeers had an Eureka! moment. Looking around, they realized that Gleevec, which had been developed by Novartis. to treat two obscure cancers — chronic myelogenous leukemia and gastrointestinal stromal tumor —enjoyed sales year of $2.2 billion in 2005.
Had the pool of patients suffering from these diseases expanded? No, But companies like Novartis were beginning to discover that there is virtually no limit to how much you can charge when you are peddling pills to dying patients. “Some patients will tolerate prices of tens of thousands of dollars a year, making drugs for even rare cancers into big moneymakers,” the Times observed.
By 2006, the Pharmaceutical Research and Manufacturers Association reported that about 400 cancer drugs from 178 companies were in clinical trials. “Competition could also bring down prices, which are now reaching $100,000 a year for some cancer drugs,” the Times speculated.
But, of course, as the chart above reveals, that didn’t happen. As I have explained in earlier posts, while competition brings down the cost of new technologies in most sectors of the economy, the rule doesn’t hold for healthcare. Unlike most consumers, seriously ill patients are not looking for bargains. They don’t want the cheapest product; they want the best. And they are quite easily persuaded that what is newest and most expensive must be top-of-the-line. In addition, a patient cannot wait until “prices come down.” He needs the medication immediately. (Keep in mind: 80 percent of our health care dollars are spent when the patient is very ill.) Thus, when it comes to healthcare, consumers have very little power over pricing.
A year after the Times announced that Pharma had finally figured out that cancer drugs could be blockbusters, the Wall Street Journal picked up the story. In a piece headlined “From Wall Street, a Warning About Cancer-Drug Prices,” the Journal focused on Dr. Steve Harr, an analyst at Morgan Stanley who was cautioning drug-makers that greed could lead to price controls. Congress “will get involved when its constituents can’t get drugs,” Harr told Genentech, which was charging $47,000 for ten months of Avastin, a drug used to treat colorectal cancer.
Is the Drug Worth the Price?
Avastin does not “cure” cancer; it slows the progress of the disease. It won approval from the FDA following a trial showing that the patients who both took the drug and followed a chemotherapy regimen lived an average of 20.3 months, versus 15.6 months for patients treated with chemotherapy alone. Genentech hailed the extra 5 months as a leap forward: “This is one of the largest improvements in survival ever reported in a randomized, Phase III study of patients with metastatic colorectal cancer.”
At the same time, the company acknowledged that patients might experience numerous side effects including Gastrointestinal (GI) perforation–which can be fatal. Researchers also have discovered that use of Avastin can lead to deep vein blood clots, increasing the risk of heart attack or stroke.
Just last October, the Scottish Medicines Consortium (SMC) advised the National Health Services (NHS) that Avastin “is not recommended for use within NHS Scotland for the treatment of patients with metastatic carcinoma of the colon or rectum” because “the manufacturer did not present a sufficiently robust economic analysis to gain acceptance.”
But in the U.S. we do not take “cost-effectiveness” into account when deciding whether to approve or cover a drug.
Harr Warns that Washington Will Begin Regulating Drug Prices
In its 2006 story the Wall Street Journal reported that Dr. Harr had been “shocked” as he saw cancer-drug prices “moving to a new level of the stratosphere in 2004. That year Erbitux, made by ImClone Systems Inc. and partner Bristol
-Myers Squibb Co. was introduced at $10,000 a month, or about $40,000 for a course of treatment “Biotech drugs, which are produced by live cells, were generally more expensive than pills that are a mixture of chemicals.” the Journal explained. “But this was twice the price of other new cancer drugs on the market, and many times the cost of older drugs.”
When Genentech introduced Avastin, Harr, who covered Genetech for Morgan Stanley, buttonholed oncologists and Genentech officials” at a conference, “pressing them about how patients could afford even the co-payment. He raised this concern with Genentech Chief Financial Officer David Ebersman. "Many plans have a 20% co-payment — that's $8,000. That's a big bite," he recalled saying
By 2007 Harr was “stunned” to discover that cancer drugs were projected to account for almost a quarter of the nation's drug spending. He acknowledged that market forces would not bring down prices the "market structure effectively provides no mechanism for price control in oncology other than companies' goodwill and tolerance for adverse publicity.”
Meanwhile, he remained convinced that soaring prices could trigger government controls. Indeed, as the Wall Street Journal noted when it published Harr’s story in March of 2007: “In November, when Democrats took control of Congress, Nancy Pelosi, the incoming Speaker of the House, put controlling drug prices at the top of the Democratic agenda. Soon after, the House passed a bill that would amend the Medicare prescription-drug benefit, to allow the government to negotiate prices with the pharmaceutical industry. The bill is pending in the Senate.”
Of course we now know that Pelosi lost that battle. Instead of allowing Medicare to use its clout to bargain for more reasonable prices, the Medicare Modernization Act specifically forbids the federal agency from trying to negotiate with drug makers.
Today–Will Medicare Reformers Be Able to Cap Prices?
Maybe not. “A unique legislative and regulatory framework shields cancer drugs (as well as a few other specialty drugs) from the strategies that health care payers such as Medicare typically use to hold down prices,” observes Dr. Bach in his recent NEJM article.
He goes on to outline ways that Medicare usually holds down spending. Often, Medicare limits coverage by specifying the types of patients who will benefit from a treatment “For instance, in 2007, Medicare narrowed the coverage of erythropoiesis-stimulating agents (ESAs) for cancer patients”. Amgen then informed investors that changes in coverage would reduce annual sales of the company's ESA, Aranesp to Medicare patients from approximately $1 billion to $200 million.
In other cases, Medicare concludes that several drugs are clinically interchangeable and encourage prices competition. One way to do this, Bach explains, is by “blending” reimbursement. “Under this approach, Medicare reimburses for the use of a particular drug on the basis of a weighted average of prices for that drug and other similar drugs, with the weighting linked to the sales volume of each drug. . . . , lower-priced drugs garner market share because their price is below the blended-reimbursement rate. As the sales of the lower-priced drugs increase and sales of the higher-priced drugs decrease, the blended-reimbursement rate declines. In July 2007, Medicare implemented blended-price reimbursement for two nebulized beta-agonist drugs that were not identical but that Medicare, through one of its contractors, deemed were clinically equivalent in their effect] and thus interchangeable.”
Medicare sometimes uses a “ least-costly-alternative (LCA) strategy, reimbursing at the price of the least costly drug among all those that are interchangeable, no matter which drug is actually used. Manufacturers respond to LCA reimbursement by lowering prices so that they are not higher than the amount of reimbursement a provider can receive after administering the drug.
“Many of the local contractors to the Medicare program have instituted LCA reimbursement for the clinically interchangeable prostate-cancer drugs leuprolide acetate (Lupron, Abbott) and goserelin acetate (Zoladex, AstraZeneca),” Bach reports. “The Office of the Inspector General estimated that in 2002, full use of LCA reimbursement for the two drugs would have saved Medicare $40 million, because the reimbursement rate for the least costly drug (goserelin acetate) was 27% lower than the alternative drug (leuprolide acetate).”
Finally , in the past Medicare has engage a third-party intermediary to obtain competitive bids when clinically interchangeable drugs are available. Under this scenario, Medicare puts out an offer to various intermediaries to bid for goods. These intermediaries negotiate with various competing manufacturers, using their purchasing leverage and the intrinsic competition among the manufacturers to obtain low prices. They then present to Medicare bids that reflect the cost savings they have achieved. Medicare recently completed a pilot program of competitive bidding for durable medical equipment and other supplies (such as home hospital beds, wheelchairs, and home oxygen-delivery machines). Through the bidding process, the Government Accountability Office estimated that Medicare saw a 26% reduction in price.
Legal Barriers to Reducing Costs
No surprise, lobbyists are adamantly opposed to any strategy that might limit their profits. And last year, they manage to persuade Congress to pass the Medicare Improvements for Patients and Providers Act which stopped Medicare’s successful pilot program dead in its tracks: Medicare will not be allowed to implement competitive bidding nationwide.
Meanwhile, the “least-costly-alternative” strategy also suffered a set back. Last year a U.S. District Court ruled that Medicare is required to reimburse for the combination brand-name inhaled drug (Duoneb a.k.a. Dey) “on the basis of the price the company charged for the drug, rather than on the basis of the cost of the drug's two components, albuterol and ipratropium, which are both available as generics.” Medicare was willing to reimburse for what it would cost to buy the two generics separately; the judge ruled it must pay the full cost of the combined brand-name drug. Judge Henry H. Kennedy declared that the policy of paying for only “the least costly alternative” was not permitted under the Medicare law. In a friend of the court brief, another drug company argued that “Congress consciously chose to entrust the amount of reimbursement to the market, not to a government agency or its contractors.” (Of course, as Morgan Stanley’s Harr observes—and as history demonstrates– when it comes to cancer drugs neither “the market” nor the consumer has the power to bring prices down. )
As for Medicare’s “blended reimbursement “strategy, Bach notes that Congress shot it down with a a complex set of laws that make it impossible for Medicare to declare that cancer drugs are interchangeable. A related law “undid a previous attempt at competitive bidding for Part B drugs, Bach notes, “stripping the bidders of any real negotiating leverage that could have come from an ability to designate clinical compounds as interchangeable.”
Manufacturers who sell cancer drugs won yet another victory in Congress when legislators first created Medicare Part D. “Under the law the private insurers that contract with Medicare to offer part D are required to include on their formularies virtually all cancer drugs that were available at the time the p
rogram was implemented in 2006,” Bach explains. “ In 2008, Congress added oral cancer drugs that came on the market after 2006: as of 2010, Part D plans must include all drugs in certain categories in which the treated condition is ‘major’ or ‘life-threatening.’ The prototypical example listed in the law is ‘drugs used in the treatment of cancer.’"
This virtually eliminates any leverage insurers might have when trying to negotiate for better prices; drug-makers know that insurers cannot threaten to leave any cancr drug out of their offerings.
Such laws underline not only the power of the lobbyists, but the general hysteria surrounding the very idea of cancer in this country. Many cancer advocates believe that cancer patients have a right to any treatment that might conceivably help them—whatever the price. The fact there is no medical evidence that the drug will help that particular patient is considered unimportant.
Looking Ahead
“Policymakers are now in a quandary,” Bach observes. “ To be sure, they are worried both by the increased total costs of cancer care and by the fact that high prices are leading to higher out-of-pocket expenses for patients. Yet, it is difficult for them to discount the progress that has been made overall in the treatment of cancer and to wholly disassociate that from the high prices that innovative cancer treatments are able to capture . . ..Some health economists argue for a causal link between high prices and the pace of innovation, which would suggest that efforts to reduce spending on cancer drugs would retard the pace of innovation.”
Yet innovation will do us little good if it produces only more more expensive drugs that neither taxpayers nor patients can afford. This is especially true when so many of these treatments offer neither comfort nor cure, but merely expose patients to the risk of extreme side effects while giving them a few more months of poor quality life.
Moreover, as in so many other areas of healthcare, we have reached a point of diminishing returns. As Back notes, while prices soar, new products are usually only minimally more effective than older, less expensive alternatives. We don’t want to encourage drug-makers to continue in this direction.
As a solution, Bach suggests that Congress consider “judiciously amending or reversinig the laws that limit Medicare's flexibility with respect to cancer drugs, while moving rapidly toward the creation of a center for comparative effectiveness that could guide Medicare's actions. Such a center could help Medicare ensure that cancer drugs are covered when their use is reasonable and necessary but are not covered when it is not. This center could also create a robust framework for classifying cancer drugs and other specialty drugs as interchangeable when they are, basing the judgment on clinical rather than pharmacologic criteria. This would achieve two ends. Manufacturers would seek to prove through clinical research that their products are not interchangeable with other compounds on the market but, rather, are superior to their competitors. Meanwhile, Medicare and other payers could apply formulas for reimbursement that would encourage lower prices when products are in fact clinically interchangeable.”
In addition, Bach notes, Medicare might consider "reference pricing," a version of LCA reimbursement in which the payer covers only the cost of the lowest-priced alternative, and patients pay the difference if they want a higher-priced item. "Payment for results" is a somewhat new idea that involves reimbursement for a drug by the payer only when it "works." One prominent example: under a preliminary agreement, Britain's National Health Service (NHS) will reimburse for doses of bortezomib (Velcade, Johnson & Johnson) when it has a therapeutic effect but not reimburse for the drug when it does not.
All of these are sensible solutions. What is certain is that decisions about how much to pay for cancer drugs, and which ones actually benefit patients, should not be made by legislators who are all-to-likely to be swayed by generous lobbyists and/or tearful advocates. Nor should they be made by judges who may let ideology cloud their thinking. Guidelines for coverage and payment must be made by scientists— unbiased physicians and medical researchers who are capable of taking a clear-eyed look at the wide array products that promise cancer patients so much, and too often, deliver so little.
Just wanted to say HI. I found your blog a few days ago and have been reading it over the past few days.
The shift in the United States, more than 20 years ago, from the institution-based, inpatient setting to community-based, ambulatory sites for treating the majority of the nation’s cancer patients has prompted in large part additional costs to the government and Medicare beneficiaries.
Not only do medical oncologists have complete logistical, administrative, marketing and financial control of the process, they also control the knowledge of the process. The result is that medical oncologist select the product, selects the vendor, decide the markup, conceal details of the transaction to the degree they wish, and deliver the product on their own terms including time, place and modality.
A joint Michigan/Harvard study confirmed that before the new Medicare reform, medical oncologists were more likely to choose cancer drugs that earn them more money. A survey by Dr. Neil Love, published in “Patterns of Care,” showed results that the Medicare reforms have not solved the problem of variations in oncology practice.
Congress wasn’t trying to reduce the payment for cancer care under the new Medicare Modernization Act (MMA) of 2003. They were simply trying to reduce overpayment for chemotherapy drugs, and paying cancer specialists the same as other physicians. The government can’t afford to overpay for drugs, in an era where all these new drugs are fantastically expensive.
Only when the profit incentive is removed from the choice of drug treatments, by taking medical oncologists out of the retail pharmacy business and forcing them to be doctors again, will Medicare be able to rein in the cost of cancer drugs.
I was tracking one of the drugs listed in the study for awhile. Every three months the price was raised. When I first started it was about $6K per month when I stopped watching nine months later it was $9K.
This one drug made the firm the darling of Wall Street during the period as its sales went from about $200 million to $1.2 billion.
Reports are now trickling in that it doesn’t work all that well over the long term and the company’s stock is in disfavor.
Robert, Gregory and runescape money
Thanks for your comments–
Robert–
Yes, that tends to be the trajectory of these drugs. One reason drug-makers are anxious to get them on the market as quickly as possible and begi promoting them immediately is because they realize that they can have a short shelf life.
At first, they are the “new, new thing” and Medical “breakthrough.” Then, as we learn more about them, we realize they are not as good as we thought.
Gregory–
I totally agree: oncologists (and doctors in general) should not be in the retail pharmacy business
The English figured this out in the 19th century (back then doctors prescribed and sold all pills) but somehow we’ve forgotten that lesson.
Some very good oncologists also don’t want to be in the drug business any more.
I’ve also seen the reserach showing that the majority of oncologists wind up choosing the most profitable treatmetns. This is inevitable. I think in most cases it’s
subconscious, but, n medicine, the profit motive always creates a conflict of interest.
What is best for profits often is not what is best for patients.
runescape money– Welcome (and a great moniker if it means what I think it means . . .)
The increasing number of chemotherapy drugs that are available in pill form as a replacement for infusion in a doctor’s office or clinic offers patients a clear convenience benefit even when it doesn’t extend life. That’s worth something. That said, I think this is one area of medicine that lends itself especially well to QALY metrics to help determine coverage and payment policy. If MedPAC recommended, for example, that we shouldn’t pay more than, say, $150K per QALY for cancer drugs and associated physician care combined, drug companies would know that there is a clear limit to what they can charge and will either price the drugs to fall within the limit or cut back on cancer R&D. Maybe cutting back on cancer R&D would be a good thing and maybe it wouldn’t. I don’t know.
At the same time, some years ago, Congress passed the Orphan Drug Act which was intended to provide an incentive for the drug industry to develop treatments for diseases and conditions that affect comparatively small populations. By necessity, to make the economics work, a high price must be charged. The poster child for this is probably Genzyme’s drug for Gaucher’s Disease, Cerezyme. The cost is over $200K per year as I understand it. Patients must take it to survive and they have to keep taking it every year. There are about 6,000 people on Cerezyme in the U.S. and 15,000 or so worldwide. Should we repeal this act and tell people with rare or uncommon diseases or conditions that they’re out of luck? It’s a tough ethical issue.
Barry:
The orphan drug law is perfect illustration of how twisted health care financing is. No rational person would devise a system where specialty treatments like these are made into monopolistic profit centers.
A rational system would have the government running such programs. The R&D and clinical testing could be done under contract just like any other of service that the government buys.
If a treatment proves effective then the government owns the rights (we paid for the studies) and contracts for the drug to be made, again at normal service markups.
There have been few cases where the actual drug was expensive to produce. Even in those limited cases efforts have been devoted to synthesizing replacements for natural extractions.
Given that, one can expect that the actual cost of orphan drugs would be modest. This would save billions in health care costs, provide better care and eliminate gaming the system.
Firms that were interested in making a decent, but not extortionate, profit would be happy to take on the contracts. Greed is now seen not only as a natural condition, but as proper.
This is really a perversion of humanistic values.
I agree with the idea of putting “orphan” drugs under govrnment control.
In fact, since most of the research used to create and perfect new drugs, especially cancer drugs, is already paid for with public or quasi-public money and performed at public or quasi-public institutions, the widely circulated idea that the government and public institutions should retain the rights to the drugs, rather than passing them on at nominal costs to private enterprises, seems like a good idea. Drug companies could be utilized to provide distribution and marketing services, and could be paid a reasonable amount for those services, but the large profits would end and costs would drop.
It seems very strange to me that we have developed a system where the public provides most of the money and risk in development of new drugs, but then pays extortionate amounts for the drugs to private companies that enter the picture very late.
addendum: before we get involved in discussion of what “quasi-public” means, I am talking about nominally private institutions that operate mostly with public money, and nominally private organizations also operating mostly with public money or with “donations” from the general public partly underwritten by tax benefits. Harvard University and the American Cancer Association are examples of these two things.
Pat and Robert,
If the government is already, in fact, largely paying for most of the research that leads to cancer drug development, then I agree that it should retain ownership of the intellectual property. As Pat says, the drug companies would need to be hired to do the marketing and distribution which would, presumably, exclude direct to consumer advertising.
Perhaps Pat could tell us to what extent cancer drugs have been developed outside of the U.S. Was that research largely paid for by government and did the foreign governments retain control of the intellectual property (patents)? If so, were the drugs made available at prices that reflect only normal markups for manufacturing, marketing and distribution?
From a taxpayer perspective, I have the following concern about government sponsored cancer drug research and, for that matter, drug research in general: Suppose the government hires various drug companies or contract research organizations or universities to conduct research on 100 different potential compounds or bioengineered approaches. Most projects are failures and need to be written off but one or two successfully make it through clinical trials and gain FDA approval. Do we price the successful drugs based only on the cost of the successful projects or do we include the cost of all the failures as well? Moreover, with no need to make a profit, how do we know when to pull the plug on projects that ultimately fail? Research budgets are finite even if taxpayers are paying and someone needs to rationally decide how to allocate resources among competing projects.
Barry:
The mechanisms for sponsoring research are well defined. We have had this is place since it emerged at the end of WWII and with Sputnik.
The funding agencies, typically NSF, NIH, DoD, DoE and the like solicit proposals from researchers. Sometimes this in a specific area, but sometimes the range is pretty vague.
Scientists submit proposals which are reviewed by teams of their peers in conjunction with grants administrators at the agencies. Those that are felt to have sufficient merit are funded and the grants administrator provides oversight for the length of the grant.
There are various milestone reports required along the way. The grants may be renewed or not according to circumstance, but if things are working properly this is based upon progress.
With basic research there is little expectation that most research will provide big breakthroughs. This is one of the distortions of the present scheme. Rather than focus on learning about the basic molecular mechanisms for disease and treatment the emphasis is on finding new (marketable) drugs.
Many firms just test thousands of compounds randomly seeking a winner. This isn’t science, it’s playing the lottery.
So, yes, the failures should be absorbed by the government and the successes should be sold at a price based upon cost of manufacture, not the desire to show an overall profit as is the case with a for-profit enterprise.
It wasn’t too long ago that all government funded research had a provision that discoveries became the property of the government. The conservatives changed that so the government bears the costs and private firms the profit.
It doesn’t seemed to have produced the scientific breakthroughs promised, but we did get a new hair tonic out of the process.
In my previous post, that should read “American Cancer Society,” not “Association.”
As far as amortizing the costs of research — it is my impression that most research that fails is not included in cost calculations, whether the research is regarding a new cancer drug or a better trigger for nuclear weapons.
It should be noted that the government and quasi-government agencies are already funding thousands of studies that “fail.” The proposal I have would not change the pattern of how research is paid for, just what happened with commercially valuable results. A critic could argue that our current policy is another example of socialism for the rich, since the drug companies do not pay the costs of the failures but get the profits from the successes.
It would be unusual for there to be hundreds of centers working on the same drug, though not unusual for there to be hundreds of centers working on the same general problem – say breast cancer treatment. Generally, costs of research are written off as costs of research, not applied to any successful research that occurs in the same field. In the setting of the scientific centers doing the work, research is considered valuable whether it succeeds or fails, since the researchers — often people working on degrees — learn something, and science also benefits from lessons from failures. Sometimes there are even interesting and valuable spin-offs from failed research — the post-it note came from development of an adhesive that turned out not to stick very well, x-rays were discovered when a mineral sample fogged film it was stored with but left the pattern of a key set on the film, and antibiotics were discovered when airborne contaminates on culture plates killed bacteria around them.
As far as how European research centers deal with commercially viable research results, I don’t know the answer myself, although a lot of drugs developed in Europe seem to end up in the hands of the same multinational drug companies who control the markets in the US.
My model for how this should work is the classic example of the quest for a cure for polio. Thousands of efforts were funded by the government and the March of Dimes, at the cost of what today would be billions, but only two succeeded. Those two – the development of the Salk and Sabin vaccines – resulted in products that were potentially worth billions in a market desperate for a cure, but were marketed by commercial companies at very small profits. Both the US and the USSR (where Sabin’s vaccine was tested) invested a lot of money in the projects that they never saw again. In the end, the benefit was the conquest of polio and the savings from not having to care for polio victims. At least in the fifties, that was considered enough for the taxpayers and the drug companies involved.
Barry,Robert, Pat S, Barry
Barry–As I have noted in the past, Americans (and the legislators who represent us) have made it clear that we are not willing to put a price on life.
We are not willing to say that an extra year of quality life is worth $100,000 or $120,000 or $90,000.
The UK is forced to do this because they have a much, much smaller health care budget, per capita.
For many Americans, this is a religious matter. Saying we’ll spend $100,000 for an extra year– and no more– means that we are deciding who should die and when.
I don’t happen to be religious, but many people believe that this is a deicision that should be made by God.
I simply don’t want to live in a society where we put a price on an individual’s life. Inevitably, very wealthy individuals would not be subject to the rules (they could pay any extra amount out of pocket) so we would be setting up two tiers –of who should live and who should die.
And no, we don’t want to tell people with rare diseases that they are “out of luck.”
But there is no need for drug companies to charge such exorbitant prices. And there is not need for them or their shareholders to reap double-digit profits (as they have for much of the past 25 years) simply because they have a gun to the customer’s head.
I agree with both Robert and Pat S. Orphan drugs should be put under government control.
Robert– Yes, I agree. And I would prefer to see non-profit firms taking the contracts in exchange for reasonable fees.
For-profit coporations are simply to greedy.
Pat S. —
Yes, the for-profit drug industry piggy-backs on government research–becomes involved late in the game, and then turns around and charges the tazpayers who originally paid for the reserach, exorbitant prices for the product.
At one time, drug companies existed mainly to distribute drugs. I would be very happy to see a return to that model.
See my response to Barry below and the descirpition of how Taxol was developed.
Barry–
First, you worry that if government is developing a drug they won’t pull the plug soon enough if it isn’t working.
This is actually a much bigger problem in the for-profit corporate world. Once a certain amount of money has been invested, resrachers feel that they must make a drug work –or at least get it into phase 3 trials–or risk losing their jobs.
Since everything is about profits, the person who dares say- “I don’t think this is going to work”–makes his boss look bad.
As for spending on drug development, Pharma likes to pretend that it spends a fortune developing 30 drugs for every durg that works–and that’s why they charge so much.
This just isn’t true.
As Pat says, they come into the process cvery late in the game. They don’t like to take risks.
See this description of how Taxol was developed:
“The pharmaceutical industry promotes the idea that the market is responsible for innovations in medicine.
“This statement obscures the enormous role that the federal government plays in the development of new drugs and therapies. The case of Taxol provides a compelling illustration of this pattern. Taxol is used most widely to treat ovarian and breast cancer and Kaposi’s sarcoma. It is also used to treat head and neck cancer, lung cancer and bladder cancer.
“Taxol is a complex compound found in the bark of the Pacific yew tree. The bark was first collected in 1962 and its potential for killing cells was demonstrated in 1964 as part of the National Cancer Institute (NCI)-United States Department of Agriculture (USDA) plant screening program.
In 1971, chemists at the Research Triangle Institute in North Carolina, a NONPROFIT tresearch organization created in 1958 by leaders in academia, business and government, first isolated the compound. The NCI selected Taxol as a development candidate in 1977 and clinical trials began in 1984. The yew bark was supplied by the Natural Products Branch of the NCI, sourced from trees located on National Forest lands. In 1989, the Johns Hopkins University Oncology Group reported that Taxol produced a very high response rate in women with ovarian cancer whose cancer had been unresponsive to other chemotherapeutic agents.
“In December 1989, the NCI chose the pharmaceutical giant Bristol-Myers Squibb as its partner in a Cooperative Research and Development Agreement (CRADA) to work on Taxol. This agreement gave Bristol-Meyers Squibb exclusive rights to develop Taxol for the commercial market and exclusive rights to all clinical data generated by the NCI from trials it had or would undertake to study the drug’s effectiveness. Bristol-Meyers Squibb also got the right of first refusal on all yew products on Federal lands as well as orphan drug status which allows firms up to 7 years exclusive marketing rights over a drug that has not been patented.”
[You might wonder why the government gave all of this to Bristol-Myers . . .Imagine how much Bristol must have spent on lobbyists and campaign contributions . . )
“Sales of Taxol in 1992 were $50 million, and they rose to $580 million in 1995. This represented one third of Bristol-Meyer Squibb’s anti-cancer drug sales in that year. This pattern of the government doing most of the work while the pharmaceutical company reaped the rewards arose from the Reluctance of Firms to Invest in the Development of New Cancer Drugs. Research and development Costs are Enormous and the return in terms of successful drugs is particularly small. For these reasons the government took over the direction of cancer research, including the search for new drugs.”
(Note: the government is interested in the public good–trying to find a cure for cancer. For-profit corporations are not–it’s too risky, too expensive.)
“The National Cancer Institute was established in 1937, and in 1953, the NCI, directed by Congress, initiated a national program of chemotherapy research, which led to the establishment of the Cancer Chemotherapy National Service Center (CCNSC) in 1955. The CCNSC facilitated collaboration between pharmaceutical companies in the collection, synthesis and testing of chemical compounds for anticancer activity. The program generated the world’s largest computerized database for experimental drugs. “In its ‘war against cancer’ (declared by President Nixon in 1971) the US state has (since the mid-1950s) funded and also managed, not just the relevant basic research but also applied research, development, formulation, toxicity testing and clinical trials of many new drugs—that is, all the R&D necessary to take a potential drug almost to the point of full scale production and market launch—in complete contrast to the ideology of “minimum government intervention and relying on market forces to ensure the appropriate allocation of resources. ”
Ideally, we should stop the practice of handing a nearly complete product over to a company like Bristol-Myers, and instead, let university or government resarchers complete development and then contact with a company to distribute it–for a reasonable price.
There should be no need for huge marketing campaigns– and certainly no need for direct-to-cosumer advertising.
Information about the drug should be disseminated through medical conferences and medical journals–and those conferences and journals should be selective, focusing only on drugs that have proven to be more effective when compared to drugs already on the market.
Oncologists will tell you that we have way too many cancer drugs–more than they can keep track of–and many of them marginally effective, at best.
Robert, Pat S.
Robert writes: “It wasn’t too long ago that all government funded research had a provision that discoveries became the property of the government. The conservatives changed that so the government bears the costs and private firms the profit.”
This is true– perhaps new legislation could take us back to the old rules.
Pat S.-
Yes the polio vaccine is a good model.
It’s worth noting that Jonas Salk didnt’ try to patent the vaccine. He said “I would no more try to patent it than I would try to patent sunlight.”
I’m paraphrasing, but he understood it belonged to everyone.
“With basic research there is little expectation that most research will provide big breakthroughs. This is one of the distortions of the present scheme. Rather than focus on learning about the basic molecular mechanisms for disease and treatment the emphasis is on finding new (marketable) drugs.”
Robert and Pat,
Learning about the basic molecular mechanisms for disease and treatment is great, but, at the end of the day, if we don’t develop useful drugs or other treatment approaches, I would consider the research a failure from a patient’s perspective. Accidental discoveries like post-it notes, x-rays and antibiotics are a separate matter.
I raised the issue of accounting for the cost of research failures because of my interest in efficient resource allocation. If the federal budget were to allocate, say, $25 billion per year for drug research, I would at least want to see that money accounted for as part of the cost of our overall healthcare system and I would want other developed countries to do the same. In Pat’s polio vaccine example, I wonder how much more we would have had to charge drug companies in licensing fees to recover the cost of research failures from vaccine revenues and to what extent, if any, would that have limited patient access to the Salk vaccine? Even if the government had to spend money on subsidies to cover the higher cost for people who couldn’t afford it, it would ensure that the cost of medical treatments (polio vaccine in this case) fully reflect the cost of producing them including research failures. I know it may seem like a minor, arcane and even irrelevant point to the doctors, but I think it is important that products and services of all types are priced to fully reflect the costs (including social costs like pollution) of producing them to the maximum possible extent.
“As I have noted in the past, Americans (and the legislators who represent us) have made it clear that we are not willing to put a price on life.”
Maggie,
While we may not (yet) be willing to put a price on life EXPLICITLY, we do it implicitly all the time. To cite just two examples, in the development of air and water pollution control regulations, part of the process includes estimating how much incremental costs would be imposed on business and consumers vs. how many premature deaths from cancer and other diseases might be avoided and how much the other positive health effects might be worth. To take an extreme example, if we thought that a proposed regulation would impose $10 billion of extra costs on the economy but would only prevent one premature cancer death, it is unlikely to become law.
Secondly, one factor that goes into setting wages for various occupations is the extent to which the job is hot, dirty or hazardous. The other factors include skill, education and responsibility as well as supply and demand and general economic conditions. There is a reason why wages are higher for underground coal miners, loggers, steel mill workers, etc. than for bank tellers, general office workers, and retail sales clerks. There are much greater occupational risks in the first category than the second and those risks are reflected in wages. However, even though the jobs are dangerous, at some price, plenty of people are willing to do them.
I simply don’t want to live in a society where we put a price on an individual’s life. Inevitably, very wealthy individuals would not be subject to the rules (they could pay any extra amount out of pocket) so we would be setting up two tiers –of who should live and who should die.
This is naive. ALL SYSTEMS ration healthcare by social class. Do you really believe that the NHS in the UK prohibits patients paying out of pocket for non-approved drugs? No healthcare system in the world does that, which means rich people will ALWAYS have more healthcare options than poor people. The people who have a problem with that need to learn how to deal with it, because no country in the world puts rich and poor people in the same tier when it comes to healthcare. Rich folks will ALWAYS have extra options in medicine that poor folk dont have access to. Learn it, live it, love it.
Good luck finding a nation to live in where rich folks dont have more options than poor people. Such a society does not exist, whether you are in the capitalist system of the USA or the central monopsony payer model of Canada, UK, France, Germany, etc
One of the keys holding back health reform in this country is this naive and stupid insistence that the rich and poor people have to be given “equal” healthcare. The only way to achieve that is to have an outright ban on all privately-purchased healthcare and to outlaw private clinics and doctors who peddle their services to rich clients.
Although I agree that the federal government should run all research trials and control all distribution and pricing of pharmaceuticals, for orphan drugs I dont think you guys will like the outcome.
Lets take the case of Gaucher’s disease posted earlier. The government will have little incentive to spend lots of research dollars on a “cure” for Gaucher’s because they will be at the mercy of lobbyists who demand that HIV/AIDS, cancer, diabetes, HTN, and other major diseases get the vast majority of funding, leaving very little funds for diseases that affect only a few thousand people.
Only when the profit incentive is removed from the choice of drug treatments, by taking medical oncologists out of the retail pharmacy business and forcing them to be doctors again, will Medicare be able to rein in the cost of cancer drugs.
This wont do anything to bring in costs. CMS already instituted a number of reforms to limit oncologist-derived markups for cancer drugs, yet overall cancer drug spending keeps going UP, not down.
The drug companies are still charging outrageous prices regardless of whether oncologists are having their mark-up or not. In fact theres some evidence that the drug companies have INCREASED their prices knowing that its harder for oncologists to have as much of a mark-up for in-house delivered chemo, expecting that big pharma can capture the extra profit that has been stripped away from the oncologists.
You’re also ignoring the fact that many of the in-house chemo drugs require close monitoring of bloodwork and vitals during administration, requiring the oncologists to deliver these drugs under supervision (usually IV drip and not avail in oral pill form). So at some level you HAVE to keep them in the loop, the question is how much of a mark-up should they get in the provision of these services. The nature of chemo drugs means that oncologists HAVE to be “retail pharmacists” in some cases. I guess the alternative is to pay big pharma or a home health care agency millions of dollars to monitor the treatments, but make no mistake, SOMEBODY is going to get paid for delivering these in-house chemo drugs.
Although the new Medicare bill tried to curtail the Chemotherapy Concession, private insurers still go along with it. It’s not that all medical oncologists are bad people, it’s just that it is still an impossible conflict of interest (i.e. it’s the SYSTEM which is rotten). The solution is to change the system. Social science research has shown that people can be biased by self-interest without being aware of it. There are so many ways for humans to rationalize their behavior.
Gregory- thanks for your comment (I will respond to everyone else tomorrow, just starting at the top of the thread)
Gregory:
You write: “It’s not that all medical oncologists are bad people, it’s just that it is still an impossible conflict of interest (i.e. it’s the SYSTEM which is rotten). The solution is to change the system. Social science research has shown that people can be biased by self-interest without being aware of it. There are so many ways for humans to rationalize their behavior.”
I completely agree.
I truly think that most of the respone to perverse fee-for-service incentives is unconscious.
There are so many reasons for doctors to precribe a treatment; it’s impossible, even for the doctor, to sort out that tangle of motives in his mind.
Price competition is fundamental to the capitalist system. In a perfect world, competition leads to the right price for product and results in value to consumers. Such competition however is anathema to health care.
Why?
We have government sponsored patent monopolies which allow patent holders to charge whatever they want for a product for a generation.
Second as noted we find it difficult as a society, as health providers and as consumers to place a monetary value on health care, a surrogate for life itself.
Third, the system is full of conflicts of interests. Providers, patients and industry all have agendas. Patients want to live but don’t fully understand the nuances of the decision. Pricing information is hard to find. Industry’s interest is in profits not the best health care decision. Information on health care decisions is complex and guarded. As a result value in medicine is an oxymoron.
Cancer therapeutic are a special case because pricing is extreme and also because patients with cancer perceive that they face the ultimate dilemma-pay or die.
I have several suggestions that won’t cost a penny and are a good start:
1. Require the government and pharmaceutical companies to negotiate prices for patented medications purchased for government programs and benficiaries. Including Medicaid, Medicare, the Federal Employee program and Tricare this would affect 100 million citizens (1/3 the population of the U.S.) Since we like transparancy we should make the negotiated prices public.
2. Enforce the reasonably pricing provisions of Dole-Bayh. Retrieve the taxpayer’s contribution to drug development costs (approximately 20 billion a year to basic medical research) from patent holders and use these proceeds to defray pharmaceutical prices to consumers. This would also require the disclosure of the real development costs of pharmaceuticals.
3. Prohibit direct to consumer (DTC) advertising. In a 30 second ad full disclosure as outlined below is not possible. As a result patients do not fully understand the limits and costs of any given product. Few countries allow such advertising.
4. If we don’t wish to completely prohibit DTC advertising, require full disclosure. This would include mention of the risks of treatment and a summary of proven benefits and competing approaches in clear language that a lay person can understand. The price of the medication, with estimates of monthly and yearly costs as well as a measure of cost effectiveness (cost/unit of additional survival time or other approved measure) must be also be provided to fully inform the consumer.
5. Require clinical studies to include cost data as well as a measure of cost effectiveness (QALY-Quality adjusted life year or other) in the discussion of any phase II, III or IV study reporting positive results.
6. Monitor the FDA approval process to be certain that generics come to market quickly on patent expiration.
7. The Canadian system controls patented drug prices by not allowing marketing unless the drug is priced right. A similar program could be instituted here to decrease our pricing to the level of other industrialized countries.
8. Alternatively, link the length of patents to reasonable pricing. As part of the patent/FDA approval process the proposed price of the new medication would be compared with similar medications already on the market and with the same medication in other countries. A process similar to that used by Canadian patent drug review board. If priced a significant amount over the comparator, the patent length would be decreased by some period of time to be determinet by the review process–there are many ways such a link could be structured. For unique innovative drugs the cost of development could also be factored into the pricing length of patent equation. Price increases during the duration of the patent would be tied to the rate of inflation. If they exceed that rate the patent length would be proportionally shortened.
http://www.medicynic.com
Barry Joe Blow
Barry–
There is an enormous difference between calculating the value of trying to reduce disease in a large population and
calculating the value of an individual life.
Can you truly not understand why no doctor, nurse or policy-maker wants to look an individual in the eye and say: we’re not giving you the life-saving organ transplant you need becuase you are 86 and at that age, the rules say you’re over the hill.”
Joe Blow-
All societies do not ration essential products by class.
In many countries, certain very expensive marginally effective drugs just aren’t available because they are not in the government’s formulary.
Health care reformers in the U.S. want to make it clear to drug-makers and device-makers that we don’t want them spendign reserach dollars on treatments that only a tiny percent of society could afford.
We don’t need or want more $100,000 treatments for cancer that give you additional months of poor-quality life.
We don’t need or want more artifical knees or hips “made especially for women” at twice the price . (All marketing hype.)
Barry–
Researchers should be focusing on basic reserach because it’s very unlikely that they are going to discover a significant, truly innovative medical product. The low-hanging frut has been pluched.
We are now waiting for
a new wave of research–perhaps based on genome
reserach—that will come 25, 30 or 40 years down the road.
The number of significant, truly new and effective drugs that have come to market in the last 10 or 15 years can be counted on the fingers of one hand. (And came from government resrearc, not the for-profit industry.)
As for measuring the true cost of everything– I’m afraid that’s a Quixotic quest and utlimately, not worth the time it would take.
What we need to measure is not the Price of everything (or cost of everything) but the Value of things. Often, the most valuable things cost very little to make–aspirin, for instance.
Joe Blow- You write:
“The government will have little incentive to spend lots of research dollars on a “cure” for Gaucher’s because they will be at the mercy of lobbyists who demand that HIV/AIDS, cancer, diabetes, HTN, and other major diseases get the vast majority of funding, leaving very little funds for diseases that affect only a few thousand people.”
Who do you think developed the many orphan drugs that we now have? Sometimes private funding got the ball rolling, but ultimately, government was usually heavily involved.
The for-profit drug industry rarely sets out to develop an “orphan drug.”
You don’t seem to understand that many people in government are actually intrested in “the public good”
For 8 years, during the Bush administration, those people were not allowed to do their jobs (I think of McClellan, head of CMS who actually wanted to reform Medicare and had some good ideas.)
But now we have an administration where NIH,
the FDA, CDC etc. will be able to work for the public good -this includes developing orphan drugs, despite pressure to put all of the money into cancer and heart disease.
Joe–Finally, you write: ”
“One of the keys holding back health reform in this country is this naive and stupid insistence that the rich and poor people have to be given “equal” healthcare.”
Joe— It’s “stupid” to believe that poor people should have equal healthcare? I certainly hope you are not a doctor. Someone with your moral vision just shouldn’t be part of the profession.
ON delivery of cancer drugs, we’re moving away from “infusions” that someone has to deliver and toward pills that patients take on their own. See NYT story.
“Can you truly not understand why no doctor, nurse or policy-maker wants to look an individual in the eye and say: we’re not giving you the life-saving organ transplant you need because you are 86 and at that age, the rules say you’re over the hill.”
The doctor, nurse or policy-maker doesn’t have to look the patient in the eye and tell him anything other than “you’re on the waiting list.” As a practical matter, however, the patient will probably never get the transplant. There are some 18,000 kidney transplants done in the U.S. each year while, at any given time, there are about 70,000 people waiting for a kidney. There is a very well established procedure for allocating available organs which is intended to ensure that scarce organs go to patients who will benefit the most which generally means younger patients. If you have a relative willing to donate a kidney, that’s a separate matter.
“We don’t need or want more $100,000 treatments for cancer that give you additional months of poor-quality life.”
Yet, if we have such a drug already on the market, you seem to suggest that everyone who needs it should get it and Medicare should pay for it even for patients who are 85 or 90 or 95 years old. I think we should just refuse to pay for it if it can’t pass a reasonable QALY metric. It shouldn’t be on the formulary or, at best, should be reimbursed at the rate of the least costly alternative treatment. I don’t care if people who can afford to choose to spend their own money for the extra few months of low quality life.
“What we need to measure is not the Price of everything (or cost of everything) but the Value of things. Often, the most valuable things cost very little to make–aspirin, for instance.”
We can’t measure the value of healthcare services, tests, procedures, drugs or devices unless we know the cost of producing or providing them and we can’t know the cost unless we have decent accounting that measures the cost properly and as completely as reasonably possible.
Obviously, we’re on different wave lengths on this one.
I’ll say this again. The only way to ensure that rich people dont get better healthcare than poor people is to OUTLAW all private health entities.
No nation on earth does this. In the UK, if the NHS refuses to pay for Tarceva, the individual is free to pay out of pocket for the expense. There is no ban on privately purchased healthcare, only limits on what the public NHS coffers will spend.
The ONLY way to make healthcare “equal” between rich and poor folks is to outlaw the rich folks from using their private funds to purchase faster MRI scans, faster access to lap cholys, MRIs for every headache no matter how mundane, etc. No country in the world, capitalist or socialist, does this.
Rich people will always have access to private doctors, private imaging, private drugs not available to the poor on the public health system. Trying to “rectify” this problem has never been achieved and has been beaten back everywhere it has been attempted (see the Canada Supreme Court ruling that outlawing private healthcare is unconstitutional).
Lets focus on something we can achieve. Dont let the unobtainable perfect become the enemy of the good. We can have a public health system TODAY that provides a BASEMENT level of healthcare access for everyone. By refusing to accept this system unless it gives “equal” healthcare to rich people and poor folks alike means that reform NEVER happens.
I just attended a cancer conference today sponsored by my local hospital.
Two interesting observations (at least to me):
1) I had forgotten to bring a pen. In the “old days” this was no problem, all of the commercial exhibitors pushing their wares would have had free pens emblazoned with their logo. I would merely have picked up a pen and used it to write with and since I am not an oncologist, I would have had no ability to be seduced by a nice pen with someone’s logo on it. However since January, pharmaceutical companies are no longer allowed to distribute free pens so I had to really search to find a pen to use. Thank god the “nanny state” is protecting me from being influenced by the logo on a free pen. (The government must think docs are really “cheap dates”)
2) You would be surprised by how much money and effort can be spent turning a 15% 5 year survival into a 20% 5 year survival. If I am ever diagnosed with a malignancy that has a 15% 5 year survival, I want to spend thousands on my farewell party rather than on the treatments that will increase my odds by 5%
“In 1989, the Johns Hopkins University Oncology Group reported that Taxol produced a very high response rate in women with ovarian cancer whose cancer had been unresponsive to other chemotherapeutic agents.”
In March 1988, the FDA released the final results of Taxol’s Phase II trials against the most virulent forms of ovarian cancer. The report revealed a response rate (tumor shrinkage) that averaged 30%. That is a far cry from being a very high response rate.
The very first reference I found of dissemination after Taxol-based chemotherapy was a NCI observational study in 1995 that reported experience in their clinic where recurrent systemic disease occurred in all patients for which they received dose-intense Taxol therapy.
I have always felt that Taxol has harmed more patients than has helped them. Having a good tumor-drug match not only would improve survival rates, it would be cost-effective, and the high cost of the newer cancer therapies reinforces the necessity of choosing the right therapy the first time around.
Legacy Flyer, Greg and Barry
I agree with Legacy Flyer that we spend enormous amounts of money developing and marketing drugs that offer just slightly better odds –and then we put enormous financial pressure on the system–and on individuals– to pay enormous sums for those drugs.
This is why I think we need to make it clear to the pharmaceutical industry that we don’t need or want more exorbitantly expensve cancer drugs that extend life by a matter of months or increase odds of survival by 5%.
Doctors need to be honest with patients by explaining to them that
a) you are dying. We just don’t have a cure for your cancer. b) there are drugs that could give you a little more time, but these are the side effects and these are the odds. . .
Perhaps there is something else you would like to do with the time you have left . . .
If it becomes clear that there isn’t a market for some of these drugs, they won’t be available, and the question of who pays for them will fade away.
Gregory– as I understand it, Taxol turned out to be a major disappointment, and may have, as you say, done more harm than good. There is just so much hype surrounding all of these cancer drugs.
Back then, I think doctors thought that if the tumor shrank, the patient was getting better, but we now know that a drug can shrink the tumor, but that doesn’t mean the patient is cured.
Yes, that tends to be the trajectory of these drugs. One reason drug-makers are anxious to get them on the market as quickly as possible and begi promoting them immediately is because they realize that they can have a short shelf life.
At first, they are the “new, new thing” and Medical “breakthrough.” Then, as we learn more about them, we realize they are not as good as we thought.